VisRx Dose Pack

pseudoephedrine, methscopolamine, and chlorpheniramine

Dosage Form: controlled-release tablets

VisRx Dose Pack Description

Each White AM tablet contains:	Each Green PM tablet contains:
Pseudoephedrine HCl .......................... 120mg	Chlorpheniramine Maleate ....................... 8mg
Methscopolamine Nitrate ...................... 2.5mg	Methscopolamine Nitrate ...................... 2.5mg

Chlorpheniramine maleate is an antihistamine having the chemical name 2-pyridinepropanamine, gamma-(4 chlorophenyl)-N, N-dimethyl-, (Z)-2-butenedioate (1:1).; C16H19ClN2•C4H4O4, MW = 390.86.

Pseudoephedrine hydrochloride is a nasal decongestant. Chemically it is [S-(R*,R*)]-α-[1(methylamino) ethyl]-benzenemethanol hydrochloride; C10H15NO•HCl, MW = 201.7.

Methscopolamine nitrate is an anticholinergic having the chemical name 3-oxa-9-azoniatricyclo [3.3.1.0 2 4] nonane, 7-(3-hydroxy-1-oxo-2-phenylpropoxy)-9, 9-dimethyl-, nitrate, [7(S)-(1α, 2β,4β, 5α, 7β)]; C17H21NO4•CH3NO3, MW = 380.4.

Inactive Ingredients

Each white tablet contains: dicalcium phosphate, hydrogenated cottonseed oil, hydroxypropyl methylcellulose, stearic acid, silicon dioxide, and magnesium stearate.

Each green tablet contains: calcium phosphate, hydrogenated cottonseed oil, hydroxypropyl methylcellulose, stearic acid, magnesium stearate, silicon dioxide, hydroxypropyl cellulose, D & C yellow lake # 10, FD & C blue lake #1.

VisRx Dose Pack - Clinical Pharmacology

Pseudoephedrine HCl is an indirect-acting sympathomimetic amine that exerts a decongestant action on the nasal mucosa. It does this by vasoconstriction, which results in reduction of tissue hyperemia, edema, nasal congestion, and an increase in nasal airway patency. In the usual dose it has minimal vasopressor effects. Pseudoephedrine HCl is rapidly and almost completely absorbed from the gastrointestinal tract. It has a plasma half-life of 6 to 8 hours. Alkaline urine is associated with slower elimination of the drug. The drug is distributed to the body tissues and fluids, including the central nervous system (CNS). Approximately 50% to 75% of the administered dose is excreted unchanged in the urine; the remainder is apparently metabolized in the liver to inactive compounds by N-demethylation, parahydroxylation, and oxidative deamination.e

Chlorpheniramine maleate is an alkylamine-type antihistamine. This group of antihistamines is among the most active histamine antagonists and is generally effective in relatively low doses.

Methscopolamine nitrate is a quaternary ammonium derivative of the anticholinergic scopolamine. As a class, these agents are poorly and unreliably absorbed. Methscopolamine nitrate has limited ability to cross the blood-brain barrier. Its antimuscarinic effect causes inhibition of salivary secretions, reduction in volume and total acid content of gastric secretion, and inhibition of gastrointestinal motility. Drug effects appear in about one hour and persist for about 4 to 6 hours. It is excreted primarily in the urine and bile, or as unabsorbed drug in feces.

Indications and Usage for VisRx Dose Pack

For the temporary relief of symptoms associated with allergic rhinitis, vasomotor rhinitis, and the common cold.

Contraindications

VisRx is contraindicated in patients with hypersensitivity to pseudoephedrine HCl, methscopolamine nitrate, and chlorpheniramine maleate. Also, VisRx is contraindicated in patients with severe hypertension, severe coronary artery disease, patients on monoamine oxidase inhibitor (MAOI) therapy or within 14 days of stopping monoamine oxidase inhibitor (MAOI) therapy, and in nursing mothers. VisRx is also contraindicated in patients with narrow-angle glaucoma, urinary retention, peptic ulcer, and during an asthmatic attack.

Warnings

Sympathomimetic amines should be used cautiously in patients with hypertension, diabetes mellitus, ischemic heart disease, hyperthyroidism, increased intraocular pressure, and prostatic hypertrophy. Sympathomimetics may produce central nervous system stimulation with convulsions or cardiovascular collapse with accompanying hypotension. The elderly (60 years or older) are more likely to exhibit adverse reactions. Antihistamines may cause excitability, especially in children. At dosages higher than the recommended dose, nervousness, dizziness, or sleeplessness may occur. Do not exceed recommended dosage.

Hypertensive crisis can occur with concurrent use of pseudoephedrine HCl and MAOI, and for 14 days after stopping therapy. Methscopolamine nitrate may produce drowsiness or blurred vision.

The patient should be cautioned regarding activities requiring mental alertness such as operating a motor vehicle or performing hazardous work while taking VisRx.

Co-administration of sildenafil citrate and other organic nitrates has been shown to potentiate the hypotension effects of nitrates. Co-administration of VisRx and sildenafil citrate has not been studied. Therefore, the use of sildenafil citrate and VisRx together is not recommended.

Precautions

General

VisRx should be used with caution in patients with diabetes mellitus, hypertension, cardiovascular disease, and hyperactivity to sympathomimetic amines. Antihistamines may cause drowsiness, and ambulatory patients who operate machinery or motor vehicles should be cautioned accordingly. Methscopolamine nitrate should be used with caution in the elderly and all patients with autonomic neuropathy, hepatic or renal disease, or ulcerative colitis.

Drug Interactions

Do not prescribe VisRx for use in patients that are now taking prescription MAOIs (certain drugs for depression, psychiatric or emotional conditions, or Parkinson’s disease), or for 14 days after stopping MAOI drug therapy. Beta-adrenergic blockers and MAOIs may potentiate the pressor effect of pseudoephedrine HCl. Concurrent use of digitalis glycosides may increase the possibility of cardiac arrhythmias. Sympathomimetics may reduce the hypotensive effects of guanethidine, mecamylamine, methyldopa, reserpine and veratrum alkaloids. Concurrent use of pseudoephedrine HCl with other sympathomimetic amines may increase pressor or cardiovascular effects of either medication.

The use of pseudoephedrine HCl may result in additive CNS depressant effects when coadministered with alcohol, antihistamines, psychotropics, or other drugs which produce CNS depression. Concurrent use of tricyclic antidepressants may antagonize the effects of pseudoephedrine HCl.

Additive anticholinergic effects may result from concomitant use with antipsychotics, tricyclic antidepressants, and other drugs with anticholinergic effects. Concomitant administration with antacids may interfere with the absorption of methscopolamine nitrate.

Carcinogenesis,Mutagenesis, Impairment of Fertility

Animal studies to assess the long-term carcinogenic and mutagenic potential or the effect on fertility in animals or humans have not been performed.

Pregnancy: Category C

It is not known whether VisRx can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. VisRx should be given to a pregnant woman only if clearly needed.

Nursing Mothers

It is not known whether this combination drug is excreted in human milk. However, pseudoephedrine HCl administered alone distributes into the breast milk of lactating human females; therefore, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.

Pediatric Use

The safety and effectiveness in children under 12 years of age have not been established.

Geriatric Use

The elderly (60 years and older) are more likely to experience adverse reactions to sympathomimetics. Overdosage of sympathomimetics in this age group may cause hallucinations, convulsions, CNS depression, and/or death. Pseudoephedrine HCl is known to be substantially excreted by the kidneys and the risk of toxic reactions to this drug may be greater in patients with impaired renal function. Because elderly patients are more likely to have decreased renal function, care should be taken in dose selection, and it may be useful to monitor renal function.

ADVERSE REACTIONS

Adverse reactions include drowsiness, lassitude, nausea, giddiness, dryness of mouth, blurred vision, cardiac palpitations, flushing, and increased irritability or excitement (especially in children). Some individuals may display sympathomimetic amine effects such as tachycardia, palpitations, headache, dizziness, or nausea. Sympathomimetics have been associated with certain untoward reactions including fear, anxiety, nervousness, restlessness, tremor, weakness, pallor, respiratory difficulty, dysuria, insomnia, hallucinations, convulsions, CNS depression, arrhythmias, and cardiovascular collapse with hypotension. Urinary retention may occur in patients with prostatic hypertrophy. Antihistamines and anticholinergics may cause drowsiness, dizziness, blurred vision, and excessive dryness of the nose, throat, and mouth.

DRUG ABUSE AND DEPENDENCE

Rebound congestion may occur after vasoconstriction subsides when pseudoephedrine HCl is discontinued. Patients may increase the amount of drug and frequency of use, producing toxicity and perpetuating the rebound congestion. Excessive use may cause systemic effects which are more likely in the elderly. Habituation and toxic psychosis have followed long-term, high-dose therapy.

OVERDOSAGE AND TREATMENT OF OVERDOSAGE

The treatment of overdosage should provide symptomatic and supportive care. Induction of emesis and gastric lavage may be performed if the patient is alert and seen within early hours after ingestion. Drug remaining in the stomach may be absorbed by the administration of activated charcoal. Stimulants should not be used because they may precipitate convulsions. If convulsions or marked CNS excitement occurs, treatment with appropriate measures is indicated. Since the effects of VisRx last up to 12 hours, the patient should be monitored for at least that length of time and treated as necessary.

DOSAGE AND ADMINISTRATION

Adults and children 12 years of age and over: One White AM tablet in the morning and one Green PM tablet in the evening. VisRx is not recommended for children under 12 years of age.

How is VisRx Dose Pack Supplied

VisRx Dose Pack 10 (NDC 68013-014-20), containing 20 controlled-release tablets in one (1) blister card as follows:

10 White AM, oval tablets with “VP” scored “7” on one side and plain on the other side, each containing 120 mg of pseudoephedrine HCl and 2.5 mg of methscopolamine nitrate.

10 Green PM, oval tablets with “VP” scored “6” on one side and plain on the other side, each containing 8 mg of chlorpheniramine maleate and 2.5 mg of methscopolamine nitrate.

VisRx Dose Pack 30 (NDC 68013-014-60), containing 60 controlled-release tablets in three (3) blister card as follows:

30 White AM, oval tablets with “VP” scored “7” on one side and plain on the other side, each containing 120 mg of pseudoephedrine HCl and 2.5 mg of methscopolamine nitrate.

30 Green PM, oval tablets with “VP” scored “6” on one side and plain on the other side, each containing 8 mg of chlorpheniramine maleate and 2.5 mg of methscopolamine nitrate.

Keep this and all medications out of the reach of children.

Store at 20-25°C (68°-77°F) excursions permitted to 15°-30°C (59°-86°F) [see USP Controlled Room Temperature]

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

Manufactured for:

Vision Pharma, LLC

Estero, FL 33928

www.visionpharma.com

By:

Nexgen Pharma, Inc.

17802 Gillette Avenue

Irvine, CA 92614

PACKAGE DISPLAY

VisRx Dose Pack 10 Blister Pack Display

NDC 68013-014-20

VisRx Dose Pack 10

Each Complete Dose Pack Contains 10 white tablets and 10 green tablets.

KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN.

Store at controlled room temperature between 20°- 25° C (68°- 77° F).

VisRx Dose Pack 30 Blister Pack Display

NDC 68013-014-60

VisRx Dose Pack 30

Each Complete Dose Pack Contains 30 white tablets and 30 green tablets.

KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN.

Store at controlled room temperature between 20°- 25° C (68°- 77° F).

VisRx Dose Pack  pseudoephedrine, methscopolamine, and chlorpheniramine  kit

Product Information Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 68013-014

Packaging # NDC Package Description Multilevel Packaging 1 68013-014-20 1 BLISTER PACK In 1 PACKAGE contains a BLISTER PACK 1 1 KIT In 1 BLISTER PACK This package is contained within the PACKAGE (68013-014-20) 2 68013-014-60 3 BLISTER PACK In 1 PACKAGE contains a BLISTER PACK 2 1 KIT In 1 BLISTER PACK This package is contained within the PACKAGE (68013-014-60)

QUANTITY OF PARTS Part # Package Quantity Total Product Quantity Part 1   10  Part 2   10

Part 1 of 2 VISRX WHITE AM CONTROLLED RELEASE  pseudoephedrine hydrochloride and methscopolamine nitrate   tablet

Product Information       Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength PSEUDOEPHEDRINE HYDROCHLORIDE (PSEUDOEPHEDRINE) PSEUDOEPHEDRINE HYDROCHLORIDE 120 mg METHSCOPOLAMINE NITRATE (METHSCOPOLAMINE) METHSCOPOLAMINE NITRATE 2.5 mg

Inactive Ingredients Ingredient Name Strength No Inactive Ingredients Found

Product Characteristics Color white Score 2 pieces Shape OVAL (Tablet) Size 14mm Flavor Imprint Code VP;7 Contains

Packaging # NDC Package Description Multilevel Packaging Package Information Not Applicable

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved drug other 03/20/2010 04/30/2011

Part 2 of 2 VISRX GREEN PM CONTROLLED RELEASE  chlorpheniramine maleate and methscopolamine nitrate  tablet

Product Information       Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength CHLORPHENIRAMINE MALEATE (CHLORPHENIRAMINE) CHLORPHENIRAMINE MALEATE 8 mg METHSCOPOLAMINE NITRATE (METHSCOPOLAMINE ) METHSCOPOLAMINE NITRATE 2.5 mg

Inactive Ingredients Ingredient Name Strength No Inactive Ingredients Found

Product Characteristics Color green Score 2 pieces Shape OVAL (Tablet) Size 14mm Flavor Imprint Code VP;6 Contains

Packaging # NDC Package Description Multilevel Packaging Package Information Not Applicable

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved drug other 03/20/2010 04/30/2011

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved drug other		03/20/2010	04/30/2011

Labeler - Vision Pharma, LLC (137210295)

Revised: 02/2011Vision Pharma, LLC

More VisRx Dose Pack resources

• VisRx Dose Pack Side Effects (in more detail)
• VisRx Dose Pack Use in Pregnancy & Breastfeeding
• VisRx Dose Pack Drug Interactions
• VisRx Dose Pack Support Group
• 2 Reviews for VisRx Dose Pack - Add your own review/rating

• VisRx Dose Pack Concise Consumer Information (Cerner Multum)


• Dallergy PSE Sustained-Release Tablets MedFacts Consumer Leaflet (Wolters Kluwer)


• DryMax Syrup MedFacts Consumer Leaflet (Wolters Kluwer)

Compare VisRx Dose Pack with other medications

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Procto-Kit 2.5% cream, ointment, suppository

Generic Name: hydrocortisone rectal (cream, ointment, suppository) (hye dro KORT i zone REK tal)

Brand Names: Anucort-HC, Anumed-HC, Anusol-HC, Cortizone-10 Anal Itch Cream, Hemorrhoidal HC, Hemril-30, Hemril-HC Uniserts, Preparation H Hydrocortisone, Procto-Kit 1%, Procto-Kit 2.5%, Procto-Pak 1%, Proctocort, Proctocream-HC, Proctosert HC, Proctosol-HC, Proctozone HC, Proctozone-H, Recort Plus, Rectasol-HC, Tucks HC

What is hydrocortisone rectal?

Hydrocortisone is a steroid medicine that reduces inflammation in the body.

The information in this medication guide is specific to hydrocortisone rectal cream, ointment, or suppository.

Hydrocortisone rectal is used to treat itching or swelling caused by hemorrhoids or other inflammatory conditions of the rectum or anus.

Hydrocortisone rectal is also used together with other medications to treat ulcerative colitis, proctitis, and other inflammatory conditions of the lower intestines and rectal area.

Hydrocortisone rectal may also be used for purposes not listed in this medication guide.

What is the most important information I should know about hydrocortisone rectal?

The information in this medication guide is specific to hydrocortisone rectal cream, ointment, or suppository.

Do not take hydrocortisone rectal by mouth. It is for use only in your rectum.

This medication comes with patient instructions for safe and effective use. Follow these directions carefully. Ask your doctor or pharmacist if you have any questions. You may need to use this medication for up to 8 weeks.

Call your doctor at once if you have any bleeding from your rectum, feeling short of breath (even with mild exertion), swelling of your ankles or feet, or rapid weight gain.

There may be other drugs that can interact with hydrocortisone rectal. Tell your doctor about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal products. Do not start a new medication without telling your doctor.

Call your doctor if your symptoms do not improve or if they get worse after using this medicine for a few days.

What should I discuss with my health care provider before using hydrocortisone rectal?

Ask a doctor or pharmacist if it is safe for you to use this medicine if you have:

• 
  

  congestive heart failure;

  
  


• 
  

  a history of tuberculosis;

  
  


• 
  

  stomach ulcer or diverticulitis;

  
  


• 
  

  a colostomy or ileostomy;

  
  


• 
  

  fever or any type of infection;

  
  


• 
  

  kidney disease;

  
  


• 
  

  high blood pressure; or

  
  


• 
  

  myasthenia gravis.

  
  

Also tell your doctor if you have diabetes. Steroid medicines may increase the glucose (sugar) levels in your blood or urine. You may also need to adjust the dose of your diabetes medications.

FDA pregnancy category C. It is not known whether hydrocortisone rectal will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant while using this medication. It is not known whether hydrocortisone passes into breast milk or if it could harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby.

How should I use hydrocortisone rectal?

Use exactly as prescribed by your doctor. Do not use in larger or smaller amounts or for longer than recommended. Follow the directions on your prescription label.

Do not take hydrocortisone rectal by mouth. It is for use only in your rectum.

This medication comes with patient instructions for safe and effective use. Follow these directions carefully. Ask your doctor or pharmacist if you have any questions. You may need to use this medication for up to 8 weeks.

Wash your hands before and after using this medicine.

Try to empty your bowel and bladder just before using hydrocortisone rectal.

Remove the outer wrapper from the suppository before inserting it. Avoid handling the suppository too long or it will melt in your hands. The rectal suppository can stain clothing or other fabrics it comes into contact with.

For best results from the suppository, lie down after inserting it and hold in the suppository. The suppository will melt quickly once inserted and you should feel little or no discomfort while holding it in.

For best results from the cream, use only the applicator provided with the medication. Otherwise, follow the directions provided with your rectal cream.

Avoid using the bathroom for one to three hours after inserting the cream or suppository.

Apply the ointment to the rectum and surrounding skin of the rectal area as directed on the package label.

Call your doctor if your symptoms do not improve or if they get worse after using this medicine for a few days.

Store the rectal cream at room temperature away from moisture and heat. Store the rectal suppositories at cool room temperature away from moisture and heat. Do not refrigerate or freeze them.

What happens if I miss a dose?

Use the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not use extra medicine to make up the missed dose.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

An overdose of hydrocortisone rectal is not expected to produce life-threatening symptoms. However, long-term use of high steroid doses can lead to symptoms such as thinning skin, easy bruising, changes in the shape or location of body fat (especially in your face, neck, back, and waist), increased acne or facial hair, menstrual problems, impotence, or loss of interest in sex.

What should I avoid while using hydrocortisone rectal ?

Avoid getting a vaccine during your treatment with hydrocortisone rectal. Vaccines may not work as well while you are using a steroid medicine.

Hydrocortisone rectal side effects

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat. Call your doctor at once if you have a serious side effect such as:

• 
  

  feeling short of breath, even with mild exertion;

  
  


• 
  

  swelling of your ankles or feet;

  
  


• 
  

  muscle weakness;

  
  


• 
  

  rapid weight gain, especially in your face and midsection;

  
  


• 
  

  severe rectal pain or burning;

  
  


• 
  

  bleeding from your rectum;

  
  


• 
  

  severe stomach pain;

  
  


• 
  

  sudden and severe headache or pain behind your eyes; or

  
  


• 
  

  seizure (convulsions).

  
  

Less serious side effects may include:

• 
  

  mild rectal pain or burning;

  
  


• 
  

  acne;

  
  


• 
  

  changes in your menstrual periods;

  
  


• 
  

  increased sweating; or

  
  


• 
  

  increased facial or body hair growth.

  
  

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What other drugs will affect hydrocortisone rectal ?

Before using hydrocortisone rectal, tell your doctor if you also use insulin or take oral diabetes medication.

There may be other drugs that can interact with hydrocortisone rectal. Tell your doctor about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal products. Do not start a new medication without telling your doctor.

More Procto-Kit 2.5% resources

• Procto-Kit 2.5% Side Effects (in more detail)
• Procto-Kit 2.5% Use in Pregnancy & Breastfeeding
• Procto-Kit 2.5% Drug Interactions
• Procto-Kit 2.5% Support Group
• 0 Reviews for Procto-Kit 2.5% - Add your own review/rating

Compare Procto-Kit 2.5% with other medications

• Anal Itching
• Aphthous Stomatitis, Recurrent
• Atopic Dermatitis
• Dermatitis
• Eczema
• Gingivitis
• Hemorrhoids
• Proctitis
• Pruritus
• Psoriasis
• Seborrheic Dermatitis
• Ulcerative Colitis, Active

Where can I get more information?

• Your pharmacist can provide more information about hydrocortisone rectal cream, ointment, or suppository.

See also: Procto-Kit 2.5% side effects (in more detail)

Ionil T Shampoo

Pronunciation: kohl tar
Generic Name: Coal Tar
Brand Name: Examples include Doak Tar and Ionil T

Ionil T Shampoo is used for:

Relieving itching, scaling, dryness, and flaking of the skin due to dandruff, psoriasis, and seborrhea. It may also be used for other conditions as determined by your doctor.

Ionil T Shampoo is a keratolytic. It works by slowing bacterial growth and loosing and softening scales and crust.

Do NOT use Ionil T Shampoo if:

• you are allergic to any ingredient in Ionil T Shampoo


• you have a condition that makes you sensitive to sunlight (eg, lupus, allergy to sunlight)

Contact your doctor or health care provider right away if any of these apply to you.

Before using Ionil T Shampoo:

Some medical conditions may interact with Ionil T Shampoo. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

• if you are pregnant, planning to become pregnant, or are breast-feeding


• if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement


• if you have allergies to medicines, foods, or other substances


• if you are using any other treatment for psoriasis, including ultraviolet radiation or a prescription medicine


• if you have eczema

Some MEDICINES MAY INTERACT with Ionil T Shampoo. However, no specific interactions with Ionil T Shampoo are known at this time.

This may not be a complete list of all interactions that may occur. Ask your health care provider if Ionil T Shampoo may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use Ionil T Shampoo:

Use Ionil T Shampoo as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• Wet the scalp and hair. Apply the medicine to the scalp, massage into a lather, and allow it to remain on the scalp for 5 minutes. Rinse thoroughly and repeat.


• Wash your hands after using Ionil T Shampoo.


• If you miss a dose of Ionil T Shampoo, use it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not use 2 doses at once.

Ask your health care provider any questions you may have about how to use Ionil T Shampoo.

Important safety information:

• Avoid getting Ionil T Shampoo in your eyes, nose, and mouth. If you get Ionil T Shampoo in your eyes, immediately wash them out with cool tap water.


• Ionil T Shampoo may be harmful if swallowed. If you may have taken Ionil T Shampoo by mouth, contact your local poison control center or emergency room immediately.


• Do not use Ionil T Shampoo on open, raw, inflamed, or infected skin.


• Do not use Ionil T Shampoo in or around the genital area, groin, or rectum unless you doctor tells you otherwise.


• Do not use Ionil T Shampoo over a large area of your body without first talking to your doctor.


• Do not use Ionil T Shampoo for a prolonged period of time without consulting your doctor.


• Ionil T Shampoo may cause increased sensitivity to the sun. Avoid exposure to the sun, sunlamps, or tanning booths until you know how you react to Ionil T Shampoo. Use a sunscreen or protective clothing if you must be outside for a prolonged period.


• Ionil T Shampoo may stain hair, skin, and clothing.


• Do not use soap, detergent, or other shampoo on your hair before or after using Ionil T Shampoo.


• Use Ionil T Shampoo with extreme caution in CHILDREN younger than 2 years of age. Safety and effectiveness in this age group have not been confirmed.


• PREGNANCY and BREAST-FEEDING: If you become pregnant, discuss with your doctor the benefits and risks of using Ionil T Shampoo during pregnancy. It is unknown if Ionil T Shampoo is excreted in breast milk. If you are or will be breast feeding while you are using Ionil T Shampoo, check with your doctor or pharmacist to discuss the risks to your baby.

Possible side effects of Ionil T Shampoo:

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Itching, burning, tenderness, or redness; sensitivity to sunlight.

Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); irritation.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

See also: Ionil T side effects (in more detail)

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately.

Proper storage of Ionil T Shampoo:

Store Ionil T Shampoo at room temperature between 68 and 77 degrees F (20 and 25 degrees C). Store away from heat, moisture, and light. Do not store in the bathroom. Brief storage at temperatures between 59 and 86 degrees F (15 and 30 degrees C) is permitted. Keep Ionil T Shampoo out of the reach of children and away from pets.

General information:

• If you have any questions about Ionil T Shampoo, please talk with your doctor, pharmacist, or other health care provider.


• Ionil T Shampoo is to be used only by the patient for whom it is prescribed. Do not share it with other people.


• If your symptoms do not improve or if they become worse, check with your doctor.


• Check with your pharmacist about how to dispose of unused medicine.

This information is a summary only. It does not contain all information about Ionil T Shampoo. If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.

Issue Date: February 1, 2012

Database Edition 12.1.1.002

Copyright © 2012 Wolters Kluwer Health, Inc.

More Ionil T resources

• Ionil T Side Effects (in more detail)
• Ionil T Use in Pregnancy & Breastfeeding
• Ionil T Support Group
• 0 Reviews for Ionil T - Add your own review/rating

Compare Ionil T with other medications

• Dermatitis
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Fentanyl Spray

Pronunciation: FEN-ta-nil
Generic Name: Fentanyl
Brand Name: Lazanda

Fentanyl Spray can be harmful or fatal if taken by children, patients for whom it has not been prescribed, or patients who are not tolerant to narcotic (opioid) pain medicine. Keep Fentanyl Spray out of the reach of children.

Fentanyl Spray is only for breakthrough pain caused by cancer in patients 18 years old and older who are already using and are tolerant to around-the-clock narcotic pain medicine. Severe and sometimes fatal breathing problems can occur in patients using Fentanyl Spray, especially in patients who are not already using other narcotic medicines or patients who are taking certain other medicines. Ask your health care provider if Fentanyl Spray may interact with other medicines that you take. Do not use Fentanyl Spray for short-term pain (including headache, dental pain, or migraine) or for pain that occurs after surgery or injuries.

Do NOT take more than the recommended dose or use more often than prescribed. You must wait at least 2 hours after your last dose of Fentanyl Spray before treating a NEW episode of breakthrough pain with Fentanyl Spray.

Do not switch between Fentanyl Spray and other medicines that contain fentanyl without first talking with your doctor. Different types of medicines that contain fentanyl may release different amounts of Fentanyl Spray into your body. This may cause severe and possibly fatal overdose. Talk with your doctor or pharmacist for more information.

Fentanyl Spray is used for:

Managing breakthrough pain in cancer patients 18 years of age and older who are already using and are tolerant to around-the-clock narcotic pain medicines.

Fentanyl Spray is a narcotic (opioid) analgesic. It works in the brain to decrease pain.

Do NOT use Fentanyl Spray if:

• you are allergic to any ingredient in Fentanyl Spray or to any similar medicine (eg, sufentanil)


• you have not been taking other narcotic pain medicines (eg, morphine, codeine) on a regular schedule


• you have mild or short-term pain, including pain from injuries, surgery, dental pain, headache, or migraine


• you are taking sibutramine or sodium oxybate (GHB)


• you are taking or have taken a monoamine oxidase inhibitor (MAOI) (eg, phenelzine) within the past 14 days

Contact your doctor or health care provider right away if any of these apply to you.

Before using Fentanyl Spray:

Some medical conditions may interact with Fentanyl Spray. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

• if you are pregnant, planning to become pregnant, or are breast-feeding


• if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement


• if you have allergies to medicines, foods, or other substances


• if you have a history of mental or mood problems (eg, depression), hallucinations, or suicidal thoughts or actions


• if you have severe drowsiness; lesions, growths, or increased pressure in the brain; or a recent head injury


• if you have lung or breathing problems (eg, asthma, slow or difficult breathing, chronic obstructive pulmonary disease [COPD]), urinary blockage, heart problems (eg, slow or irregular heartbeat, ventricle problems), liver or kidney disease, inflammation in the mouth, an enlarged prostate or benign prostatic hypertrophy (BPH), stomach or bowel problems (eg, constipation, inflammatory bowel disease, pseudomembranous colitis, stomach pain), an underactive thyroid, low blood pressure, or seizures


• if you or a family member has a history of alcohol, narcotic, or other substance abuse or dependence


• if you have been very ill, have a fever, have poor health or nutrition, or have had a recent surgery (eg, stomach or bowel surgery)


• if you stop taking your around-the-clock narcotic pain medicine

Some MEDICINES MAY INTERACT with Fentanyl Spray. Tell your health care provider if you are taking any other medicines, especially any of the following:

• Amiodarone, antihistamines (eg, diphenhydramine), aprepitant, azole antifungals (eg, ketoconazole), benzodiazepines (eg, diazepam), calcium channel blockers (eg, diltiazem, verapamil), cimetidine, macrolides (eg, erythromycin, clarithromycin), MAOIs (eg, phenelzine), nefazodone, other opioid medicines (eg, oxycodone), phenothiazines (eg, chlorpromazine), protease inhibitors (eg, ritonavir), skeletal muscle relaxants (eg, cyclobenzaprine), sleep medicines (eg, zolpidem), sodium oxybate (GHB), or telithromycin because they may increase the risk of Fentanyl Spray's side effects, including serious breathing problems, severe light-headedness or dizziness, or severe drowsiness


• Serotonin reuptake inhibitors (eg, fluoxetine) or sibutramine because a severe reaction that may include fever, rigid muscles, blood pressure changes, mental changes, confusion, irritability, agitation, delirium, and coma may occur


• Mixed agonist/antagonist analgesics (eg, pentazocine, buprenorphine, butorphanol), nalmefene, naloxone, or naltrexone because they may decrease Fentanyl Spray's effectiveness and withdrawal symptoms may occur


• Barbiturates (eg, phenobarbital), carbamazepine, corticosteroids (eg, prednisone), efavirenz, modafinil, certain nasal decongestants (eg, oxymetazoline), nevirapine, oxcarbazepine, phenytoin, pioglitazone, rifamycins (eg, rifampin), St. John's wort, or troglitazone because they may decrease Fentanyl Spray's effectiveness

This may not be a complete list of all interactions that may occur. Ask your health care provider if Fentanyl Spray may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use Fentanyl Spray:

Use Fentanyl Spray as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• Fentanyl Spray comes with an extra patient information sheet called a Medication Guide. Read it carefully. Read it again each time you get Fentanyl Spray refilled.


• When you first start to use Fentanyl Spray, your doctor may adjust your dose to find the dose that controls your pain the best. Be sure to follow the directions for using Fentanyl Spray provided by your doctor. Do NOT change your dose of Fentanyl Spray without checking with your doctor.


• Do not remove Fentanyl Spray from the child-resistant container until you are ready to use it. Replace the bottle in the child-resistant container between doses of Fentanyl Spray. Keep Fentanyl Spray, both unopened and opened bottles, in the child-resistant container and out of the reach of children at all times.


• Before you use a new bottle for the first time, you will need to prime it. Prime the bottle according to the directions in the medication guide. Contact your pharmacist if you are unsure how to prime the bottle.


• To be sure that Fentanyl Spray is ready to be used, be sure that you see either a green bar or a number in the counting window.


• If you have a runny nose, blow your nose before using Fentanyl Spray.


• To use a dose of Fentanyl Spray, remove the protective cap from the tip and sit up with your head upright. Hold the bottle with your thumb on the bottom, and your first and middle fingers on the finger grips. Place the tip of the spray container into the nose and point it toward the bridge of your nose. Using a finger from your other hand, press against the opposite nostril to close it off. Press down on the finger grips until you hear a click. Breathe in gently through your nose and out through your mouth 1 time after spraying. Do not sniff after spraying Fentanyl Spray in your nose.


• If your dose is equal to 2 sprays of Fentanyl Spray, repeat these steps in the other nostril. Do NOT use more than 1 dose of Fentanyl Spray per episode of breakthrough pain.


• Stay seated for at least 1 minute after using Fentanyl Spray. Avoid blowing your nose for at least 30 minutes after each spray.


• After you are done using your dose, replace the protective cap on the tip of the bottle and return the bottle to the child-resistant container.


• After each spray, the number in the counting window will increase by 1. When you see a red number 8 in the counting window, the bottle is finished. You may still see medicine in the bottle but there is not enough for a full dose.


• If your breakthrough pain does NOT get better within 30 minutes after your dose, follow your doctor's directions about taking other medicine to manage your pain. If your breakthrough pain does not get better, contact your doctor.


• Wait at least 2 hours after your last dose of Fentanyl Spray before treating a NEW episode of breakthrough pain. If you have more than 4 episodes of breakthrough pain per day, tell your doctor.


• Dispose of Fentanyl Spray if you have used 8 sprays from a bottle, if it has been 5 days since you last used it, or if it has been 14 days since you primed it. If Fentanyl Spray is no longer needed, dispose of it as soon as possible. Ask your doctor or pharmacist how to dispose of Fentanyl Spray properly.


• Check with your doctor before including grapefruit or grapefruit juice in your diet while you use Fentanyl Spray.


• Fentanyl Spray is usually used as needed. If you forget to use a dose of Fentanyl Spray and you still have pain, use it when you remember and as directed by your doctor. Do not take 2 doses at once.

Ask your health care provider any questions you may have about how to use Fentanyl Spray.

Important safety information:

• Fentanyl Spray may cause drowsiness or dizziness. These effects may be worse if you take it with alcohol or certain medicines. Use Fentanyl Spray with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.


• Do not drink alcohol while you are using Fentanyl Spray.


• Check with your doctor before you use medicines that may cause drowsiness (eg, sleep aids, muscle relaxers) while you are using Fentanyl Spray; it may add to their effects. Ask your pharmacist if you have questions about which medicines may cause drowsiness.


• Fentanyl Spray may cause dizziness, light-headedness, or fainting; alcohol, hot weather, exercise, or fever may increase these effects. To prevent them, sit up or stand slowly, especially in the morning. Sit or lie down at the first sign of any of these effects.


• Constipation is a common side effect of Fentanyl Spray. Talk with your doctor about using laxatives or stool softeners while you use Fentanyl Spray to prevent or treat constipation. It is also important to maintain a diet adequate in fiber, drink plenty of water, and exercise to prevent constipation.


• Do NOT take more than the recommended dose, use more often than prescribed, or suddenly stop using Fentanyl Spray without checking with your doctor.


• Tell your doctor or dentist that you use Fentanyl Spray before you receive any medical or dental care, emergency care, or surgery.


• Contact your doctor if your pain is not relieved or if it worsens after you use Fentanyl Spray. Contact your doctor if your usual dose stops providing pain relief. Be sure to tell your doctor or health care provider how your pain is responding to Fentanyl Spray so that your dose can be adjusted if needed.


• Do not switch between Fentanyl Spray and other medicines that contain fentanyl without first talking to your doctor. Different types of medicines that contain fentanyl may release different amounts of Fentanyl Spray into your body. This may cause severe and possibly fatal overdose. Discuss any questions or concerns with your doctor or pharmacist.


• Use Fentanyl Spray with caution in the ELDERLY; they may be more sensitive to its effects, especially breathing problems.


• Fentanyl Spray can be harmful, even fatal, if used in CHILDREN. Keep Fentanyl Spray out of the reach of children.


• PREGNANCY and BREAST-FEEDING: Fentanyl Spray may cause harm to the fetus. If you think you may be pregnant, contact your doctor. You will need to discuss the benefits and risks of using Fentanyl Spray while you are pregnant. Fentanyl Spray is found in breast milk. Do not breast-feed while using Fentanyl Spray.

When used for long periods of time or at high doses, Fentanyl Spray may not work as well and may require higher doses to obtain the same effect as when first taken. This is known as TOLERANCE. Talk with your doctor if Fentanyl Spray stops working well. Do not take more than prescribed.

When used for long periods of time or at high doses, some people develop a need to continue taking Fentanyl Spray. This is known as DEPENDENCE or "addiction."

If you suddenly stop taking Fentanyl Spray, you may experience WITHDRAWAL symptoms, including anxiety; diarrhea; fever, runny nose, or sneezing; goose bumps and abnormal skin sensations; nausea; vomiting; pain; rigid muscles; rapid heartbeat; seeing, hearing, or feeling things that are not there; shivering or tremors; sweating; and trouble sleeping.

Possible side effects of Fentanyl Spray:

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Constipation; dizziness; drowsiness; headache; nasal discomfort; nausea; stuffy or runny nose; taste changes; vomiting.

Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, throat, or tongue); chest pain; confusion; coughing up blood; difficult or painful urination; fainting; fast, slow, or irregular heartbeat; fever; hallucinations; mood or mental changes (eg, depression); seizures; severe drowsiness; severe or persistent dizziness or headache; severe or persistent stomach pain; shortness of breath; slowed, shallow, or trouble breathing; unusual weakness or tiredness.

If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

See also: Fentanyl side effects (in more detail)

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately. Symptoms may include loss of consciousness; muscle rigidity; pinpoint pupils; severe drowsiness or dizziness; slow or shallow breathing; very slow or weak heartbeat.

Proper storage of Fentanyl Spray:

Store Fentanyl Spray below 77 degrees F (25 degrees C). Store in the original package, away from heat, moisture, and light. Do not store in the bathroom. Do not freeze. Keep Fentanyl Spray out of the reach of children and away from pets.

General information:

• If you have any questions about Fentanyl Spray, please talk with your doctor, pharmacist, or other health care provider.


• Fentanyl Spray is to be used only by the patient for whom it is prescribed. Do not share it with other people.


• If your symptoms do not improve or if they become worse, check with your doctor.


• Check with your pharmacist about how to dispose of unused medicine.

This information is a summary only. It does not contain all information about Fentanyl Spray. If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.

Issue Date: February 1, 2012

Database Edition 12.1.1.002

Copyright © 2012 Wolters Kluwer Health, Inc.

More Fentanyl resources

• Fentanyl Side Effects (in more detail)
• Fentanyl Use in Pregnancy & Breastfeeding
• Fentanyl Drug Interactions
• Fentanyl Support Group
• 149 Reviews for Fentanyl - Add your own review/rating

Compare Fentanyl with other medications

• Anesthesia
• Anesthetic Adjunct
• Breakthrough Pain
• Pain
• Postoperative Pain
• Sedation

Ixempra

Generic Name: ixabepilone (IX ab EP i lone)

Brand Names: Ixempra

What is ixabepilone?

Ixabepilone is used to treat advanced breast cancer.

Ixabepilone is usually given after other cancer medications have been tried without successful treatment.

Ixabepilone may also be used for purposes not listed in this medication guide.

What is the most important information I should know about ixabepilone?

Do not use ixabepilone if you are pregnant. It could harm the unborn baby. You should not receive this medication if you are allergic to ixabepilone, or to a medication ingredient called Cremophor (synthetic castor oil). You may not be able to receive ixabepilone if you have severe liver disease, or severely low platelets or white blood cell counts.

Before you receive ixabepilone, tell your doctor if you have liver disease, heart disease, nerve problems, diabetes, bone marrow suppression, or a weak immune system.

Ixabepilone can lower blood cells that help your body fight infections. Avoid being near people who are sick or have infections. Your blood may need to be tested often. Visit your doctor regularly.

Tell your doctor at once if you develop signs of infection, such as fever, chills, body aches, flu symptoms, pale skin, easy bruising or bleeding, or sores in your mouth and throat. Avoid drinking alcohol during your treatment with ixabepilone.

What should I discuss with my health care provider before receiving ixabepilone?

You should not receive this medication if you are allergic to ixabepilone, or to a medication ingredient called Cremophor (synthetic castor oil). You may not be able to receive ixabepilone if you have severe liver disease, or severely low platelets or white blood cell counts.

To make sure you can safely receive ixabepilone, tell your doctor if you have any of these other conditions:

• 
  

  liver disease;

  
  


• 
  

  heart disease;

  
  


• 
  

  nerve problems (especially in your hands or feet);

  
  


• 
  

  diabetes; or

  
  


• 
  

  bone marrow suppression or weak immune system.

  
  

FDA pregnancy category D. Do not use ixabepilone if you are pregnant. It could harm the unborn baby. Use effective birth control, and tell your doctor if you become pregnant during treatment. It is not known whether ixabepilone passes into breast milk or if it could harm a nursing baby. You should not breast-feed while receiving ixabepilone.

How is ixabepilone given?

Ixabepilone is injected into a vein through an IV. You will receive this injection in a clinic or hospital setting. Ixabepilone must be given slowly, and the IV infusion can take up to 3 hours to complete.

Ixabepilone is usually given every 3 weeks.

About 1 hour before you receive ixabepilone, you may be given other medications to help prevent certain side effects.

Ixabepilone can lower blood cells that help your body fight infections. This can make it easier for you to bleed from an injury or get sick from being around others who are ill. Your blood may need to be tested often. Visit your doctor regularly.

What happens if I miss a dose?

Call your doctor for instructions if you miss an appointment for your ixabepilone injection.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

What should I avoid while receiving ixabepilone?

Avoid being near people who are sick or have infections. Tell your doctor at once if you develop signs of infection.

Avoid drinking alcohol during your treatment with ixabepilone.

Ixabepilone side effects

Get emergency medical help if you have any of these signs of an allergic reaction: hives; warmth or tingly feeling; difficulty breathing; swelling of your face, lips, tongue, or throat. Tell your caregivers at once if you have any of these serious side effects:

• 
  

  numbness, tingling, burning pain, discomfort, or loss of feeling anywhere in your body;

  
  


• 
  

  fever, chills, body aches, flu symptoms, sores in your mouth and throat;

  
  


• 
  

  easy bruising, unusual bleeding (nose, mouth, vagina, or rectum), purple or red pinpoint spots under your skin;

  
  


• 
  

  pale skin, feeling light-headed or short of breath, rapid heart rate, trouble concentrating;

  
  


• 
  

  sudden numbness or weakness, especially on one side of the body;

  
  


• 
  

  sudden severe headache, confusion, problems with vision, speech, or balance;

  
  


• 
  

  pain or burning when you urinate;

  
  


• 
  

  chest pain or heavy feeling; or

  
  


• 
  

  redness, swelling, and pain on the palms of your hands or the soles of your feet.

  
  

Less serious side effects include:

• 
  

  tired feeling;

  
  


• 
  

  joint or muscle pain;

  
  


• 
  

  hair loss;

  
  


• 
  

  nausea, vomiting, stomach pain, loss of appetite;

  
  


• 
  

  diarrhea or constipation; or

  
  


• 
  

  problems with your fingernails or toenails.

  
  

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What other drugs will affect ixabepilone?

Many drugs can interact with ixabepilone. Below is just a partial list. Tell your doctor if you are using:

• 
  

  bosentan (Tracleer);

  
  


• 
  

  dexamethasone (Cortastat, DexPak, Solurex);

  
  


• 
  

  St. John's wort;

  
  


• 
  

  rifabutin (Mycobutin), rifampin (Rifadin, Rifater, Rifamate), or rifapentine (Priftin);

  
  


• 
  

  an antibiotic such as clarithromycin (Biaxin), dalfopristin/quinupristin (Synercid), erythromycin (E.E.S., EryPed, Ery-Tab, Erythrocin), nafcillin (Nallpen, Unipen), or telithromycin (Ketek);

  
  


• 
  

  an antidepressant such as nefazodone;

  
  


• 
  

  antifungal medication such as clotrimazole (Mycelex Troche), itraconazole (Sporanox), ketoconazole (Extina, Ketozole, Nizoral, Xolegal), or voriconazole (Vfend);

  
  


• 
  

  a barbiturate such as butabarbital (Butisol), secobarbital (Seconal), pentobarbital (Nembutal), or phenobarbital (Solfoton);

  
  


• 
  

  heart or blood pressure medication such as diltiazem (Cartia, Cardizem), felodipine (Plendil), nifedipine (Nifedical, Procardia), verapamil (Calan, Covera, Isoptin, Verelan), and others;

  
  


• 
  

  HIV /AIDS medicine such as atazanavir (Reyataz), delavirdine (Rescriptor), efavirenz (Sustiva), etravirine (Intelence), indinavir (Crixivan), nelfinavir (Viracept), nevirapine (Viramune), ritonavir (Norvir), or saquinavir (Invirase, Fortovase);

  
  


• 
  

  medicines to treat narcolepsy, such as armodafanil (Nuvigil) or modafanil (Progivil); or

  
  


• 
  

  seizure medication such as carbamazepine (Carbatrol, Tegretol), felbamate (Felbatol), fosphenytoin (Cerebyx), oxcarbazepine (Trileptal), phenytoin (Dilantin), or primidone (Mysoline).

  
  

This list is not complete and other drugs may interact with ixabepilone. Tell your doctor about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal products. Do not start a new medication without telling your doctor.

More Ixempra resources

• Ixempra Side Effects (in more detail)
• Ixempra Use in Pregnancy & Breastfeeding
• Ixempra Drug Interactions
• Ixempra Support Group
• 0 Reviews for Ixempra - Add your own review/rating

• Ixempra Prescribing Information (FDA)


• Ixempra Monograph (AHFS DI)


• Ixempra Advanced Consumer (Micromedex) - Includes Dosage Information


• Ixempra Consumer Overview


• Ixempra MedFacts Consumer Leaflet (Wolters Kluwer)


• Ixabepilone Professional Patient Advice (Wolters Kluwer)

Compare Ixempra with other medications

• Breast Cancer
• Breast Cancer, Metastatic

Where can I get more information?

• Your doctor or pharmacist can provide more information about ixabepilone.

See also: Ixempra side effects (in more detail)

Dioctyl Capsules

1. Name Of The Medicinal Product

Dioctyl 100 mg Capsules.

DulcoEase, 100 mg capsules

2. Qualitative And Quantitative Composition

Docusate sodium 100 mg.

For excipients, see Section 6.1.

3. Pharmaceutical Form

Capsules

A two colour (opaque white and opaque yellow) soft, oval, gelatin capsule with a clear, colourless liquid fill.

4. Clinical Particulars

4.1 Therapeutic Indications

a) To prevent and treat chronic constipation.

(i) to soften hard, dry stools in order to ease defaecation and reduce straining at stool; and

(ii) in the presence of haemorrhoids and anal fissure, to prevent hard, dry stools and reduce straining.

b) As an adjunct in abdominal radiological procedures.

4.2 Posology And Method Of Administration

Route of administration: Oral

Adults and elderly:

Up to 500 mg should be taken daily in divided doses. Treatment should be commenced with large doses, which should be decreased as the condition of the patient improves.

For use with barium meals:

400 mg to be taken with the meal.

Children under 12 years:

Not recommended.

4.3 Contraindications

These capsules should not be administered when abdominal pain, nausea, vomiting or intestinal obstruction is present.

This product should not be given to patients with a known hypersensitivity to Dioctyl capsules or any of the components.

Patients with rare hereditary problems of fructose intolerance should not take this medicine.

4.4 Special Warnings And Precautions For Use

Organic disorders should be excluded prior to the administration of any laxative.

The treatment of constipation with any medicinal product is only adjuvant to a healthy lifestyle and diet, for example:

• Increased intake of fluids and dietary fibre.

• Advice on appropriate physical activity

If laxatives are needed every day, or if there is persistent abdominal pain, consult your doctor.

Contains sorbitol: do not use this medicine if you are intolerant to small quantities of sugar (sorbitol, fructose).

Contains colouring E110 which may cause allergic reactions.

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

These capsules should not be taken concurrently with mineral oil.

4.6 Pregnancy And Lactation

There are no adequate data from the use of the drug in pregnant women. Animal studies are insufficient with respect to effects on pregnancy and embryonic foetal development. The potential risk for humans is unknown. During wide use, no adverse consequences have been reported.

Use in pregnancy only if the benefits outweigh the risks.

Docusate sodium is excreted in breast milk and should therefore, be used with caution in lactating mothers.

4.7 Effects On Ability To Drive And Use Machines

None known.

4.8 Undesirable Effects

Rarely, these capsules can cause diarrhoea, nausea, abdominal cramps or skin rash.

4.9 Overdose

In rare cases of overdose, excessive loss of water and electrolytes should be treated by encouraging the patient to drink plenty of fluid. Electrolyte loss should be replenished where appropriate.

5. Pharmacological Properties

5.1 Pharmacodynamic Properties

ATC code: A06A02 Laxatives, softeners, emollients

Docusate sodium is an anionic wetting agent, which acts as a faecal softener by lowering the surface tension and allowing penetration of accumulated hard dry faeces by water and salts.

Docusate Sodium also possesses stimulant activity.

5.2 Pharmacokinetic Properties

Docusate sodium exerts its clinical effect in the gastrointestinal tract. There is some evidence that docusate sodium is absorbed and is excreted in the bile. There is also evidence that docusate sodium is capable of enhancing absorption of certain compounds administered concomitantly.

5.3 Preclinical Safety Data

None Stated

6. Pharmaceutical Particulars

6.1 List Of Excipients

Macrogol 400

Propylene glycol

Gelatin 195 bloom

Purified water

Sorbitol special

Glycerol

Titanium dioxide E171

Quinoline yellow E104

Sunset yellow E110

6.2 Incompatibilities

None.

6.3 Shelf Life

3 years.

6.4 Special Precautions For Storage

Do not store above 25ºC. Store in the original package in order to protect from moisture.

6.5 Nature And Contents Of Container

PVC/PVdC blister packs with aluminium foil containing 10, 20, 30, 40 or 50 capsules.

Polyethylene / polypropylene containers, e.g.: securitainers / tampertainers containing 30, 100 and 250 capsules.

Not all pack sizes may be marketed.

6.6 Special Precautions For Disposal And Other Handling

None

7. Marketing Authorisation Holder

UCB Pharma Limited

208 Bath Road

Slough

Berkshire

SL1 3WE

United Kingdom

8. Marketing Authorisation Number(S)

PL 00039/0737

9. Date Of First Authorisation/Renewal Of The Authorisation

28 February 2008

10. Date Of Revision Of The Text

Thioplex

Generic Name: thiotepa (THYE oh TEP a)

Brand Names: Thioplex

What is Thioplex (thiotepa)?

Thiotepa is a cancer (antineoplastic) medication. Thiotepa interferes with the growth of cancer cells and slows their growth and spread in the body.

Thiotepa is used in the treatment of cancers of the breast, ovary, bladder, and others.

Thiotepa may also be used for purposes other than those listed in this medication guide.

What is the most important information I should know about Thioplex (thiotepa)?

Thiotepa should only be administered under the supervision of a qualified healthcare provider experienced in the use of cancer chemotherapeutic agents.

Serious side effects have been reported with the use of thiotepa including: allergic reactions (difficulty breathing; closing of the throat; swelling of the lips, tongue, or face; or hives); severe heart damage with prolonged use; decreased bone marrow function and blood problems (extreme fatigue; easy bruising or bleeding; black, bloody or tarry stools; fever or chills; or signs of infection); severe nausea, vomiting, diarrhea, and loss of appetite; and others. Talk to your doctor about the possible side effects from treatment with thiotepa.

What should I discuss with my healthcare provider before using Thioplex (thiotepa)?

Do not use thiotepa without first talking to your doctor if you have

• kidney disease;


• liver disease; or


• 
  

  poor bone marrow function.

  
  

The use of thiotepa may be dangerous if you have any of the conditions listed above.

Thiotepa is in the FDA pregnancy category D. This means that thiotepa is known to be harmful to an unborn baby. Do not use thiotepa without first talking to your doctor if you are pregnant. Discuss with your doctor the appropriate use of birth control during treatment with thiotepa if either you or your partner is of childbearing potential. It is not known whether thiotepa passes into breast milk. Do not take thiotepa without first talking to your doctor if you are breast-feeding a baby. The safety and effectiveness of thiotepa in children has not been established.

How should I use Thioplex (thiotepa)?

Thiotepa should only be administered under the supervision of a qualified healthcare provider experienced in the use of cancer chemotherapeutic agents.

Your doctor will determine the correct amount and frequency of treatment with thiotepa depending upon the type of cancer being treated and other factors. Talk to your doctor if you have any questions or concerns regarding the treatment schedule.

Your doctor will probably want you to have regularly scheduled blood tests and other medical evaluations during treatment with thiotepa to monitor progress and side effects.

Skin accidentally exposed to thiotepa should be rinsed thoroughly with soap and warm water.

Your healthcare provider will store thiotepa as directed by the manufacturer. If you are storing thiotepa at home, follow the directions provided by your healthcare provider.

What happens if I miss a dose?

Contact your doctor if you miss a dose of thiotepa.

What happens if I overdose?

If for any reason an overdose of thiotepa is suspected, seek emergency medical attention or contact your healthcare provider immediately.

Symptoms of a thiotepa overdose tend to be similar to side effects caused by the medication, although often more severe.

What should I avoid while using Thioplex (thiotepa)?

Thiotepa can lower the activity of your immune system making you susceptible to infections. Avoid contact with people who have colds, the flu, or other contagious illnesses and do not receive vaccines that contain live strains of a virus (e.g., live oral polio vaccine) during treatment with thiotepa. In addition, avoid contact with individuals who have recently been vaccinated with a live vaccine. There is a chance that the virus can be passed on to you.

Skin accidentally exposed to thiotepa should be rinsed thoroughly with soap and warm water.

Thioplex (thiotepa) side effects

If you experience any of the following serious side effects from thiotepa, seek emergency medical attention or contact your doctor immediately:

• 
  

  an allergic reaction (including difficulty breathing; closing of the throat; swelling of the lips, tongue, or face; or hives);

  
  


• 
  

  decreased bone marrow function and blood problems (extreme fatigue; easy bruising or bleeding; black, bloody or tarry stools; or fever, chills, or signs of infection);

  
  


• 
  

  tissue or vein reactions near the site of administration;

  
  


• 
  

  liver damage (abdominal pain, yellowing of the skin or eyes);

  
  


• 
  

  severe nausea, vomiting, or loss of appetite;

  
  


• 
  

  fever, chills, or other signs of infection; or

  
  


• 
  

  painful or difficult urination.

  
  

Other, less serious side effects may be more likely to occur. Continue taking thiotepa and talk to your doctor if you experience:

• 
  

  fatigue or weakness;

  
  


• 
  

  mild to moderate nausea, vomiting, or loss of appetite;

  
  


• 
  

  redness or inflammation of the eyes;

  
  


• 
  

  dizziness, headache, or blurred vision;

  
  


• 
  

  temporary hair loss;

  
  


• 
  

  a loss of skin coloration; or

  
  


• 
  

  decreased menstruation in women and decreased sperm production in men.

  
  

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What other drugs will affect Thioplex (thiotepa)?

Do not receive "live" vaccines during treatment with thiotepa. Administration of a live vaccine may be dangerous during treatment with thiotepa.

Drugs other than those listed here may also interact with thiotepa. Talk to your doctor and pharmacist before taking any other prescription or over-the-counter medicines, including herbal products, during treatment with thiotepa.

More Thioplex resources

• Thioplex Side Effects (in more detail)
• Thioplex Use in Pregnancy & Breastfeeding
• Thioplex Drug Interactions
• Thioplex Support Group
• 0 Reviews for Thioplex - Add your own review/rating

• Thioplex Advanced Consumer (Micromedex) - Includes Dosage Information


• Thiotepa Prescribing Information (FDA)


• Thiotepa Professional Patient Advice (Wolters Kluwer)


• Thiotepa MedFacts Consumer Leaflet (Wolters Kluwer)

Compare Thioplex with other medications

• Bladder Cancer
• Breast Cancer
• Cancer
• Lymphoma
• Ovarian Cancer
• Serosal Cavity Neoplastic Disease

Where can I get more information?

• Your healthcare provider may have additional information about thiotepa that you may read.

See also: Thioplex side effects (in more detail)

progestin Oral, Parenteral, Vaginal

Commonly used brand name(s)

In the U.S.

• Aygestin


• Camila


• Crinone


• Errin


• First-Progesterone VGS


• Jolivette


• Megace


• Megace ES


• Next Choice


• Ovrette


• Plan B


• Prochieve


• Prometrium

In Canada

• Alti-Mpa


• Megace Os

Available Dosage Forms:

• Tablet


• Suspension


• Capsule, Liquid Filled


• Gel/Jelly


• Cream


• Kit


• Suppository

Uses For progestin

Progestins are hormones. They are used by both men and women for different purposes.

Progestins are prescribed for several reasons:

• To properly regulate the menstrual cycle and treat unusual stopping of the menstrual periods (amenorrhea). Progestins work by causing changes in the uterus. After the amount of progestins in the blood drops, the lining of the uterus begins to come off and vaginal bleeding occurs (menstrual period). Progestins help other hormones start and stop the menstrual cycle. .


• To help a pregnancy occur during egg donor or infertility procedures in women who do not produce enough progesterone. Also, progesterone is given to help maintain a pregnancy when not enough of it is made by the body.


• To prevent estrogen from thickening the lining of the uterus (endometrial hyperplasia) in women around menopause who are being treated with estrogen for ovarian hormone therapy (OHT). OHT is also called hormone replacement therapy (HRT) and estrogen replacement therapy (ERT).


• To treat pain that is related to endometriosis, a condition where the endometrial tissue which lines the uterus becomes displaced in other female organs.


• To treat a condition called endometriosis, to help prevent endometrial hyperplasia, or to treat unusual and heavy bleeding of the uterus (dysfunctional uterine bleeding) by starting or stopping the menstrual cycle.


• To help treat cancer of the breast, kidney, or uterus. Progestins help change the cancer cell's ability to react to other hormones and proteins that cause tumor growth. In this way, progestins can stop the growth of a tumor.


• To test the body's production of certain hormones such as estrogen.


• To treat loss of appetite and severe weight or muscle loss in patients with acquired immunodeficiency syndrome (AIDS) or cancer by causing certain proteins to be produced that cause increased appetite and weight gain.

Progestins may also be used for other conditions as determined by your doctor.

Depending on how much and which progestin you use or take, a progestin can have different effects. For instance, high doses of progesterone are necessary for some women to continue a pregnancy while other progestins in low doses can prevent a pregnancy from occurring. Other effects include causing weight gain, increasing body temperature, developing the milk-producing glands for breast-feeding, and relaxing the uterus to maintain a pregnancy.

Progestins can help other hormones work properly. Progestins may help to prevent anemia (low iron in blood), too much menstrual blood loss, and cancer of the uterus.

Progestins are available only with your doctor's prescription.

Once a medicine has been approved for marketing for a certain use, experience may show that it is also useful for other medical problems. Although these uses are not included in product labeling, progestins are used in certain patients with the following medical conditions:

• Carcinoma of the prostate


• Corpus luteum insufficiency


• Hot flashes


• Polycystic ovary syndrome


• Precocious puberty

Before Using progestin

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to medicines in this group or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Although there is no specific information comparing use of progestins in children or teenagers with use in other age groups, progestin is not expected to cause different side effects or problems in children or teenagers than it does in adults.

Geriatric

progestin has been tested and has not been shown to cause different side effects or problems in older people than it does in younger adults.

Pregnancy

Progesterone, a natural hormone that the body makes during pregnancy, has not caused problems. In fact, it is sometimes used in women to treat a certain type of infertility and to aid in egg donor or infertility procedures.

Other progestins have not been studied in pregnant women. Be sure to tell your doctor if you become pregnant while using any of the progestins. It is best to use some kind of birth control method while you are receiving progestins in high doses. High doses of progestins are not recommended for use during pregnancy since there have been some reports that they may cause birth defects in the genitals (sex organs) of a male fetus. Also, some of these progestins may cause male-like changes in a female fetus and female-like changes in a male fetus, but these problems usually can be reversed. Low doses of progestins, such as those doses used for contraception, have not caused major problems when used accidentally during pregnancy.

Breast Feeding

Although progestins pass into the breast milk, they have not been shown to cause problems in nursing babies. However, progestins may change the quality or amount (increase or decrease) of the mother's breast milk. It may be necessary for you to take another medicine or to stop breast-feeding during treatment. Be sure you have discussed the risks and benefits of the medicine with your doctor.

Interactions with Medicines

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking any of these medicines, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using medicines in this class with any of the following medicines is not recommended. Your doctor may decide not to treat you with a medication in this class or change some of the other medicines you take.

• Boceprevir


• Dofetilide

Using medicines in this class with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Felbamate


• Isotretinoin


• Theophylline


• Tizanidine


• Tranexamic Acid

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other Medical Problems

The presence of other medical problems may affect the use of medicines in this class. Make sure you tell your doctor if you have any other medical problems, especially:

• Asthma or


• Epilepsy (or history of) or


• Heart or circulation problems or


• Kidney disease (severe) or


• Migraine headaches—Progestins may cause fluid retention which may cause these conditions to become worse.

• Bleeding problems, undiagnosed, such as blood in the urine or changes in vaginal bleeding—May make diagnosis of these problems more difficult.

• Blood clots, or history of or


• Breast cancer, or history of or


• Deep vein thrombosis (blood clot in the leg), active or history of or


• Heart attack, active or history of or


• Liver disease, including jaundice, or history of or


• Pulmonary embolism (clot in the lung), active or history of or


• Stroke , active or history of or


• Venous thromboembolism (clot in the veins), or history of—Progestins should not be used in patients with these conditions.

• Breast disease (such as breast lumps or cysts), history of—May make this condition worse for diseases that do not react in a positive way to progestins.

• Diabetes mellitus—May cause an increase in your blood sugar and a change in the amount of medicine you take for diabetes; progestins in high doses are more likely to cause this problem.

• Memory loss (dementia)—May make this condition worse.

• Vision changes—progestin may cause changes in vision; your medicine may need to be stopped if these conditions become worse.

Proper Use of progestin

To make the use of a progestin as safe and reliable as possible, you should understand how and when to take it and what effects may be expected. Progestins usually come with patient directions. Read them carefully before taking or using progestin.

Take progestin only as directed by your doctor. Do not take more of it and do not take it for a longer time than your doctor ordered. To do so may increase the chance of side effects. Try to take the medicine at the same time each day to reduce the possibility of side effects and to allow it to work better.

Progestins are often given together with certain medicines. If you are using a combination of medicines, make sure that you take each one at the proper time and do not mix them. Ask your health care professional to help you plan a way to remember to take your medicines at the right times.

Dosing

The dose medicines in this class will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of these medicines. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

• For medroxyprogesterone


• For oral dosage form (tablets):
  
  • For controlling unusual and heavy bleeding of the uterus (dysfunctional uterine bleeding) or treating unusual stopping of menstrual periods (amenorrhea):
    
    • Adults and teenagers—5 to 10 milligrams (mg) per day for five to ten days as directed by your doctor.
    
    
  
  
  • For preparing the uterus for the menstrual period:
    
    • Adults and teenagers—10 milligrams (mg) per day for five or ten days as directed by your doctor.
    
    
  
  
  • For preventing estrogen from thickening the lining of the uterus (endometrial hyperplasia) when taking estrogen for ovarian hormone therapy in postmenopausal women:
    
    • Adults—When taking estrogen each day on Days 1 through 25: Oral, 5 to 10 milligrams (mg) of medroxyprogesterone per day for ten to fourteen or more days each month as directed by your doctor. Or, your doctor may want you to take 2.5 or 5 mg per day without stopping. Your doctor will help decide the number of tablets that is best for you and when to take them.
    
    
  
  


• For intramuscular injection dosage form:
  
  • For treating cancer of the kidneys or uterus:
    
    • Adults and teenagers—At first, 400 to 1000 milligrams (mg) injected into a muscle as a single dose once a week. Then, your doctor may lower your dose to 400 mg or more once a month.
    
    
  
  


• For subcutaneous injection dosage form:
  
  • For treating pain related to endometriosis:
    
    • Adults and teenagers—104 milligrams (mg) injected under the skin of the anterior thigh or abdomen every three months (12 to 14 weeks) for not more than 2 years.
    
    
  
  

• For megestrol


• For oral dosage form (suspension):
  
  • For treating loss of appetite (anorexia), muscles (cachexia), or weight caused by acquired immunodeficiency syndrome (AIDS):
    
    • Adults and teenagers—800 milligrams (mg) a day for the first month. Then your doctor may want you to take 400 or 800 mg a day for three more months.
    
    
  
  


• For oral dosage form (tablets):
  
  • For treating cancer of the breast:
    
    • Adults and teenagers—160 milligrams (mg) a day as a single dose or in divided doses for two or more months.
    
    
  
  
  • For treating cancer of the uterus:
    
    • Adults and teenagers—40 to 320 milligrams (mg) a day for two or more months.
    
    
  
  
  • For treating loss of appetite (anorexia), muscles (cachexia), or weight caused by cancer:
    
    • Adults and teenagers—400 to 800 milligrams (mg) a day.
    
    
  
  

• For norethindrone


• For oral dosage form (tablets):
  
  • For controlling unusual and heavy bleeding of the uterus (dysfunctional uterine bleeding) or treating unusual stopping of menstrual periods (amenorrhea):
    
    • Adults and teenagers—2.5 to 10 milligrams (mg) a day from Day 5 through Day 25 (counting from the first day of the last menstrual cycle). Or, your doctor may want you to take the medicine only for five to ten days as directed.
    
    
  
  
  • For treating endometriosis:
    
    • Adults and teenagers—At first, 5 milligrams (mg) a day for two weeks. Then, your doctor may increase your dose slowly up to 15 mg a day for six to nine months. Let your doctor know if your menstrual period starts. Your doctor may want you to take more of the medicine or may want you to stop taking the medicine for a short period of time.
    
    
  
  

• For progesterone


• For oral dosage form (capsules):
  
  • For preventing estrogen from thickening the lining of the uterus (endometrial hyperplasia) when taking estrogen for ovarian hormone therapy in postmenopausal women:
    
    • Adults—200 milligrams (mg) per day at bedtime for 12 continuous days per 28-day cycle of estrogen treatment each month.
    
    
  
  
  • For treating unusual stopping of menstrual periods (amenorrhea):
    
    • Adults—400 milligrams (mg) per day at bedtime for ten days.
    
    
  
  


• For vaginal dosage form (gel):
  
  • For treating unusual stopping of menstrual periods (amenorrhea):
    
    • Adults and teenagers—45 milligrams (mg) (one applicatorful of 4% gel) once every other day for up to six doses. Dose may be increased to 90 mg (one applicatorful of 8% gel) once every other day for up to six doses if needed.
    
    
  
  
  • For use with infertility procedures:
    
    • Adults and teenagers—90 milligrams (mg) (one applicatorful of 8% gel) one or two times a day. If pregnancy occurs, treatment can continue for up to ten to twelve weeks.
    
    
  
  


• For injection dosage form:
  
  • For controlling unusual and heavy bleeding of the uterus (dysfunctional uterine bleeding) or treating unusual stopping of menstrual periods (amenorrhea):
    
    • Adults and teenagers—5 to 10 milligrams (mg) a day injected into a muscle for six to ten days. Or, your doctor may want you to receive 100 or 150 mg injected into a muscle as a single dose. Sometimes your doctor may want you first to take another hormone called estrogen. If your menstrual period starts, your doctor will want you to stop taking the medicine.
    
    
  
  


• For vaginal dosage form (suppositories):
  
  • For maintaining a pregnancy (at ovulation and at the beginning of pregnancy):
    
    • Adults and teenagers—25 mg to 100 milligrams (mg) (one suppository) inserted into the vagina one or two times a day beginning near the time of ovulation. Your doctor may want you to receive the medicine for up to eleven weeks.
    
    
  
  

Missed Dose

If you miss a dose of progestin, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

For all progestins, except for progesterone capsules for postmenopausal women: If you miss a dose of progestin, take the missed dose as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

For progesterone capsules for postmenopausal women: If you miss a dose of 200 mg of progesterone capsules at bedtime, take 100 mg in the morning then go back to your regular dosing schedule. If you take 300 mg of progesterone a day and you miss your morning and evening doses, you should not take the missed dose. Return to your regular dosing schedule.

Storage

Keep out of the reach of children.

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Do not keep outdated medicine or medicine no longer needed.

Precautions While Using progestin

It is very important that your doctor check your progress at regular visits. This will allow for your dosage to be adjusted and for any unwanted effects to be detected. These visits will usually be every 6 to 12 months, but some doctors require them more often.

The Prometrium® capsules contain peanut oil. If you have an allergy to peanuts, make sure your doctor knows this before you take this brand of progestin.

Progestins may cause some people to become dizzy. For oral or vaginal progesterone, dizziness or drowsiness may occur 1 to 4 hours after taking or using it. Make sure you know how you react to progestin before you drive, use machines, or do anything else that could be dangerous if you are not alert.

Unusual or unexpected vaginal bleeding of various amounts may occur between your regular menstrual periods during the first 3 months of use. This is sometimes called spotting when slight, or breakthrough menstrual bleeding when heavier. If this should occur, continue on your regular dosing schedule. Check with your doctor:

• If unusual or unexpected vaginal bleeding continues for an unusually long time.


• If your menstrual period has not started within 45 days of your last period.

Missed menstrual periods may occur. If you suspect a pregnancy, you should stop taking progestin immediately and call your doctor. Your doctor will let you know if you should continue taking the progestin.

If you are scheduled for any laboratory tests, tell your health care professional that you are taking a progestin. Progestins can change certain test results.

In some patients, tenderness, swelling, or bleeding of the gums may occur. Brushing and flossing your teeth carefully and regularly and massaging your gums may help prevent this. See your dentist regularly to have your teeth cleaned. Check with your medical doctor or dentist if you have any questions about how to take care of your teeth and gums, or if you notice any tenderness, swelling, or bleeding of your gums.

You will need to use a birth control method while taking progestins for noncontraceptive use if you are fertile and sexually active.

If you are using vaginal progesterone, avoid using other vaginal products for 6 hours before and for 6 hours after inserting the vaginal dose of progesterone.

Since it is possible that certain doses of progestins may cause temporary thinning of the bones by changing your hormone balance, it is important that your doctor know if you have an increased risk of osteoporosis. Some things that can increase your risk for having osteoporosis include cigarette smoking, abusing alcohol, taking or drinking large amounts of caffeine, and having a family history of osteoporosis or easily broken bones. Some medicines, such as glucocorticoids (cortisone-like medicines) or anticonvulsants (seizure medicine), can also cause thinning of the bones. However, it is thought that progestins can help protect against osteoporosis in postmenopausal women.

progestin Side Effects

Along with their needed effects, progestins used in high doses sometimes cause some unwanted effects such as blood clots, heart attacks, and strokes, or problems of the liver and eyes. Although these effects are rare, some of them can be very serious and cause death. It is not clear if these problems are due to the progestin. They may be caused by the disease or condition for which progestins are being used.

The following side effects may be caused by blood clots. Although not all of these side effects may occur, if they do occur they need immediate medical attention.

Get emergency help immediately if any of the following side effects occur:

Rare

• Symptoms of blood clotting problems, usually severe or sudden, such as:


• headache or migraine


• loss of or change in speech, coordination, or vision


• numbness of or pain in chest, arm, or leg


• unexplained shortness of breath

Check with your doctor as soon as possible if any of the following side effects occur:

More common

• Changes in vaginal bleeding (increased amounts of menstrual bleeding occurring at regular monthly periods, lighter vaginal bleeding between menstrual periods, heavier vaginal bleeding between regular monthly periods, or stopping of menstrual periods)


• symptoms of blood sugar problems (dry mouth, frequent urination, loss of appetite, or unusual thirst)

Less common

• Mental depression


• skin rash


• unexpected or increased flow of breast milk

RareFor megestrol—During chronic treatment

• Backache


• dizziness


• filling or rounding out of the face


• irritability


• mental depression


• nausea or vomiting


• unusual decrease in sexual desire or ability in men


• unusual tiredness or weakness

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common

• Abdominal pain or cramping


• bloating or swelling of ankles or feet


• blood pressure increase (mild)


• dizziness


• drowsiness (progesterone only)


• headache (mild)


• mood changes


• nervousness


• pain or irritation at place of injection site


• swelling of face, ankles, or feet


• unusual or rapid weight gain

Less common

• Acne


• breast pain or tenderness


• brown spots on exposed skin, possibly long-lasting


• hot flashes


• loss or gain of body, facial, or scalp hair


• loss of sexual desire


• trouble in sleeping

Not all of the side effects listed above have been reported for each of these medicines, but they have been reported for at least one of them. All of the progestins are similar, so any of the above side effects may occur with any of these medicines.

After you stop using progestin, your body may need time to adjust. The length of time this takes depends on the amount of medicine you were using and how long you used it. During this period of time check with your doctor if you notice the following side effect:

For megestrol

• Dizziness


• nausea or vomiting


• unusual tiredness or weakness

• Delayed return to fertility


• stopping of menstrual periods


• unusual menstrual bleeding (continuing)

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

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