pneumococcal 13-valent vaccine, diphtheria conjugate Intramuscular

NOO-moe-KOK-al 13-VAY-lent VAX-een, dif-THEER-ee-a KON-joo-gate

Commonly used brand name(s)

In the U.S.

• Prevnar 13

In Canada

• Prevnar

Available Dosage Forms:

• Suspension

Uses For pneumococcal 13-valent vaccine, diphtheria conjugate

Pneumococcal 13-valent diphtheria conjugate vaccine is an active immunizing agent used to prevent infection by pneumococcal bacteria. It works by causing your body to produce its own protection (antibodies) against the disease.

Pneumococcal infection can cause serious problems, such as pneumonia, which affects the lungs; meningitis, which affects the brain; and bacteremia, which is a severe infection in the blood. Pneumococcal infection is also an important cause of ear infections in children.

Unless otherwise contraindicated, immunization (vaccination) against pneumococcal disease is recommended for infants and young children 6 weeks to 5 years of age (prior to the 6th birthday) or to adults 50 years of age and older.

For infants and young children, immunization requires 1 to 4 doses of the vaccine, depending on the age at the first dose. This vaccine can be given at the same time as other routine vaccinations.

This vaccine is to be administered only by or under the supervision of your doctor.

Before Using pneumococcal 13-valent vaccine, diphtheria conjugate

In deciding to use a vaccine, the risks of taking the vaccine must be weighed against the good it will do. This is a decision you and your doctor will make. For this vaccine, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to pneumococcal 13-valent vaccine, diphtheria conjugate 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

The pneumococcal 13-valent diphtheria conjugate vaccine is generally well-tolerated and effective in infants. The safety and effectiveness in infants younger than 6 weeks of age and in children older than 6 years of age have not been established.

Geriatric

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of pneumococcal 13-valent diphtheria conjugate vaccine in the elderly.

Pregnancy

	Pregnancy Category	Explanation
All Trimesters	B	Animal studies have revealed no evidence of harm to the fetus, however, there are no adequate studies in pregnant women OR animal studies have shown an adverse effect, but adequate studies in pregnant women have failed to demonstrate a risk to the fetus.

Breast Feeding

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

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. Tell your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.

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 this vaccine. Make sure you tell your doctor if you have any other medical problems, especially:

• Apnea in premature babies (breathing stops for short periods)—Use with caution. May make this condition worse.

• Immune system problems (e.g., cancer, HIV, kidney or spleen problems)—This vaccine may not work as well in patients with a weak immune system.

Proper Use of pneumococcal 13-valent vaccine, diphtheria conjugate

A nurse or other trained health professional will give you or your child this vaccine. This vaccine is given as a shot into one of the muscles, usually in the thigh or upper arm.

For infants and young children 6 weeks to 5 years of age (prior to the 6th birthday): This vaccine is usually given as 4 separate shots over several months. Your child's doctor will tell you the correct number of shots that are needed and the schedule to be followed for the vaccine.

For adults 50 years of age and older: This vaccine is given as a single dose.

It is very important for your child to receive all of the shots for the vaccine.

The vaccine needs to be given on a fixed schedule. Try to keep all of the scheduled appointments. If your child misses a dose, call your child’s doctor for another appointment.

Precautions While Using pneumococcal 13-valent vaccine, diphtheria conjugate

It is very important that your child return to your doctor’s office at the right time for all of the doses. Be sure to notify your doctor of any side effects that occur after your child receives this vaccine.

This vaccine may cause a serious type of allergic reaction called anaphylaxis. Anaphylaxis can be life-threatening and requires immediate medical attention. Tell your doctor right away if you or your child has a rash, itching, swelling of the tongue and throat, or trouble breathing after receiving the vaccine.

The pneumococcal 13-valent diphtheria conjugate vaccine will not protect you or your child against all types of pneumococcal infections. It will also not treat an active infection.

pneumococcal 13-valent vaccine, diphtheria conjugate Side Effects

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor or nurse immediately if any of the following side effects occur:

More common

• Fever

Rare

• Chest pain


• chills


• coughing, wheezing, or shortness of breath


• difficult or labored breathing


• difficulty with swallowing


• fast heartbeat


• noisy breathing


• seizures


• shortness of breath


• skin itching, rash, or redness


• sneezing


• sore throat


• swelling of the face, throat, or tongue


• tightness in the chest

Incidence not known

• Bladder pain


• blistering, peeling, or loosening of the skin


• bloody or cloudy urine


• bluish lips or skin


• body aches or pain


• choking


• confusion


• decreased urine output


• diarrhea


• difficult, burning, or painful urination


• dilated neck veins


• ear congestion


• extreme fatigue


• fainting


• frequent urge to urinate


• general feeling of discomfort or illness


• headache


• hives


• irregular breathing


• irregular heartbeat


• itching


• joint or muscle pain


• large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs


• lightheadedness


• loss of appetite


• loss of voice


• lower back or side pain


• muscle aches and pains


• nasal congestion


• nausea


• not breathing


• puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue


• rapid, shallow breathing


• red, irritated eyes


• runny nose


• shivering


• sore throat


• sores, ulcers, or white spots in the mouth or on the lips


• sweating


• swelling of the face, fingers, feet, or lower legs


• swollen, painful, or tender lymph glands in the neck, armpit, or groin


• trouble sleeping


• troubled breathing


• unusual tiredness or weakness


• vomiting


• weight gain

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

• Decreased appetite


• decreased sleep


• irritability


• red streaks on the skin


• swelling, tenderness, or pain at the injection site

Rare

• Abdominal or stomach pain


• crying


• hives or welts


• weakness

Incidence not known

• Bleeding, blistering, burning, coldness, discoloration of the skin, feeling of pressure, hives, infection, inflammation, itching, lumps, numbness, rash, redness, scarring, soreness, stinging, tingling, ulceration, or warmth at the injection site


• burning, dry, or itching eyes


• eye discharge or excessive tearing


• pain


• stomach cramps


• tenderness

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.

See also: pneumococcal3-valent vaccine, diphtheria conjugate Intramuscular side effects (in more detail)

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More pneumococcal 13-valent vaccine, diphtheria conjugate Intramuscular resources

• Pneumococcal 13-valent vaccine, diphtheria conjugate Intramuscular Side Effects (in more detail)
• Pneumococcal 13-valent vaccine, diphtheria conjugate Intramuscular Use in Pregnancy & Breastfeeding
• Pneumococcal 13-valent vaccine, diphtheria conjugate Intramuscular Drug Interactions
• Pneumococcal 13-valent vaccine, diphtheria conjugate Intramuscular Support Group
• 0 Reviews for Pneumococcal3-valent vaccine, diphtheria conjugate Intramuscular - Add your own review/rating

Compare pneumococcal 13-valent vaccine, diphtheria conjugate Intramuscular with other medications

• Pneumococcal Disease Prophylaxis

Histacol BD Drops

Generic Name: brompheniramine, dextromethorphan, and pseudoephedrine (brom fen EER a meen, dex troe me THOR fan, soo doe e FED rin)

Brand Names: Allanhist PDX Drops, Anaplex DM, Anaplex DMX, Andehist DM NR Syrup, Brom Tann, Bromaline DM, Bromdex D, Bromfed DM, Bromhist PDX, Bromhist-DM Drops, Bromophed-DX, Bromph DM, Bromplex DM, BroveX PSE DM, Dallergy DM, EndaCof-DM, Histacol BD Drops, Myphetane DX Cough, Neo DM, PBM Allergy, Pediahist DM Drops, ProHist DM, Q-Tapp DM, Resperal-DM Drops, Robitussin Allergy & Cough, Sildec DM

What is Histacol BD Drops (brompheniramine, dextromethorphan, and pseudoephedrine)?

Brompheniramine is an antihistamine that reduces the effects of the natural chemical histamine in the body. Histamine can produce symptoms of sneezing, itching, watery eyes, and runny nose.

Dextromethorphan is a cough suppressant. It affects the signals in the brain that trigger cough reflex.

Pseudoephedrine is a decongestant that shrinks blood vessels in the nasal passages. Dilated blood vessels can cause nasal congestion (stuffy nose).

The combination of brompheniramine, dextromethorphan, and pseudoephedrine is used to treat runny or stuffy nose, sneezing, itching, watery eyes, cough, and sinus congestion caused by allergies, the common cold, or the flu.

This medicine will not treat a cough that is caused by smoking, asthma, or emphysema.

Brompheniramine, dextromethorphan, and pseudoephedrine may also be used for purposes not listed in this medication guide.

What is the most important information I should know about Histacol BD Drops (brompheniramine, dextromethorphan, and pseudoephedrine)?

Do not give this medication to a child younger than 4 years old. Always ask a doctor before giving a cough or cold medicine to a child. Death can occur from the misuse of cough and cold medicines in very young children. You should not use this medication if you have severe constipation, a blockage in your stomach or intestines, or if you are unable to urinate. Do not use cough or cold medicine if you have untreated or uncontrolled diseases such as glaucoma, asthma or COPD, high blood pressure, heart disease, coronary artery disease, or overactive thyroid. Do not use cough or cold medicine if you have used an MAO inhibitor such as furazolidone (Furoxone), isocarboxazid (Marplan), phenelzine (Nardil), rasagiline (Azilect), selegiline (Eldepryl, Emsam, Zelapar), or tranylcypromine (Parnate) in the last 14 days. A dangerous drug interaction could occur, leading to serious side effects.

What should I discuss with my healthcare provider before taking Histacol BD Drops (brompheniramine, dextromethorphan, and pseudoephedrine)?

Do not use cough or cold medicine if you have used an MAO inhibitor such as furazolidone (Furoxone), isocarboxazid (Marplan), phenelzine (Nardil), rasagiline (Azilect), selegiline (Eldepryl, Emsam, Zelapar), or tranylcypromine (Parnate) in the last 14 days. A dangerous drug interaction could occur, leading to serious side effects. You should not use this medication if you have severe constipation, a blockage in your stomach or intestines, or if you are unable to urinate. Do not use cough or cold medicine if you have untreated or uncontrolled diseases such as glaucoma, asthma or COPD, high blood pressure, heart disease, coronary artery disease, or overactive thyroid.

Ask a doctor or pharmacist if it is safe for you to take this medication if you have:

• 
  

  a blockage in your digestive tract (stomach or intestines), a colostomy or ileostomy;

  
  


• 
  

  diabetes;

  
  


• 
  

  liver or kidney disease;

  
  


• 
  

  epilepsy or other seizure disorder;

  
  


• 
  

  cough with mucus, or cough caused by emphysema or chronic bronchitis;

  
  


• 
  

  enlarged prostate or urination problems;

  
  


• 
  

  low blood pressure;

  
  


• 
  

  pheochromocytoma (an adrenal gland tumor); or

  
  


• 
  

  if you take potassium (Cytra, Epiklor, K-Lyte, K-Phos, Kaon, Klor-Con, Polycitra, Urocit-K).

  
  

FDA pregnancy category C. It is not known whether this medication will harm an unborn baby. Do not use cough or cold medicine without medical advice if you are pregnant. This medicine may pass into breast milk and may harm a nursing baby. Antihistamines and decongestants may also slow breast milk production. Do not use cough or cold medicine without medical advice if you are breast-feeding a baby.

How should I take Histacol BD Drops (brompheniramine, dextromethorphan, and pseudoephedrine)?

Use exactly as directed on the label, or as prescribed by your doctor. Do not use in larger or smaller amounts or for longer than recommended. Cough or cold medicine is usually taken only for a short time until your symptoms clear up.

Do not give this medication to a child younger than 4 years old. Always ask a doctor before giving a cough or cold medicine to a child. Death can occur from the misuse of cough and cold medicines in very young children.

Do not take for longer than 7 days in a row. Talk with your doctor if your symptoms do not improve after 7 days of treatment, or if you have a fever with a headache or skin rash.

Measure liquid medicine with a special dose-measuring spoon or medicine cup, not with a regular table spoon. If you do not have a dose-measuring device, ask your pharmacist for one.

If you need surgery or medical tests, tell the surgeon or doctor ahead of time if you have taken a cough or cold medicine within the past few days. Store at room temperature away from moisture and heat. Do not freeze.

What happens if I miss a dose?

Since cough or cold medicine is taken when needed, you may not be on a dosing schedule. If you are taking the medication regularly, take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not take 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.

Overdose symptoms may include severe forms of some of the side effects listed in this medication guide.

What should I avoid while taking Histacol BD Drops (brompheniramine, dextromethorphan, and pseudoephedrine)?

This medicine may cause blurred vision and may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be alert and able to see clearly. Drinking alcohol can increase certain side effects of this medication. Ask a doctor or pharmacist before using any other cold, allergy, cough, or sleep medicine. Antihistamines, cough suppressants, and decongestants are contained in many combination medicines. Taking certain products together can cause you to get too much of a certain drug. Check the label to see if a medicine contains an antihistamine, cough suppressant, or decongestant.

Avoid taking this medication if you also take diet pills, caffeine pills, or other stimulants (such as ADHD medications). Taking a stimulant together with a decongestant can increase your risk of unpleasant side effects.

Avoid becoming overheated or dehydrated during exercise and in hot weather. This medication can decrease sweating and you may be more prone to heat stroke.

Histacol BD Drops (brompheniramine, dextromethorphan, and pseudoephedrine) side effects

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

• 
  

  fast, slow, or uneven heart rate;

  
  


• 
  

  severe headache, mood changes, hallucinations;

  
  


• 
  

  severe dizziness or anxiety, feeling like you might pass out;

  
  


• 
  

  tremor, seizure (convulsions);

  
  


• 
  

  easy bruising or bleeding, unusual weakness;

  
  


• 
  

  fever;

  
  


• 
  

  urinating less than usual or not at all;

  
  


• 
  

  feeling short of breath; or

  
  


• 
  

  dangerously high blood pressure (severe headache, blurred vision, buzzing in your ears, anxiety, confusion, chest pain, uneven heartbeats, seizure).

  
  

Less serious side effects may include:

• 
  

  mild headache;

  
  


• 
  

  mild dizziness, drowsiness;

  
  


• 
  

  dry mouth, nose, or throat;

  
  


• 
  

  nausea, diarrhea, constipation, upset stomach;

  
  


• 
  

  feeling nervous, restless, or irritable;

  
  


• 
  

  blurred vision; or

  
  


• 
  

  sleep problems (insomnia).

  
  

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 Histacol BD Drops (brompheniramine, dextromethorphan, and pseudoephedrine)?

Ask a doctor or pharmacist before using this medicine if you regularly use other medicines that make you sleepy (such as narcotic pain medication, sedatives, sleeping pills, muscle relaxers, and medicine for seizures, depression or anxiety). They can add to sleepiness caused by brompheniramine or dextromethorphan.

Ask a doctor or pharmacist if it is safe for you to take this medication if you are also using any of the following drugs:

• 
  

  atropine (Atreza, Sal-Tropine);

  
  


• 
  

  benztropine (Cogentin);

  
  


• 
  

  topiramate (Topamax);

  
  


• 
  

  zonisamide (Zonegran);

  
  


• 
  

  an antidepressant such as citalopram (Celexa), duloxetine (Cymbalta), escitalopram (Lexapro), fluoxetine (Prozac, Sarafem, Symbyax), paroxetine (Paxil, Pexeva), sertraline (Zoloft), venlafaxine (Effexor), and others;

  
  


• 
  

  anti-nausea medications such as belladonna (Donnatal), dimenhydrinate (Dramamine), droperidol (Inapsine), methscopolamine (Pamine), or scopolamine (Transderm Scop);

  
  


• 
  

  bladder or urinary medications such as darifenacin (Enablex), flavoxate (Urispas), oxybutynin (Ditropan, Oxytrol), solifenacin (Vesicare), tolterodine (Detrol), or Urogesic Blue;

  
  


• 
  

  bronchodilators such as ipratropium (Atrovent) or tiotropium (Spiriva);

  
  


• 
  

  irritable bowel medications such as dicyclomine (Bentyl), hyoscyamine (Hyomax), or propantheline (Pro Banthine); or

  
  


• 
  

  ulcer medicine such as glycopyrrolate (Robinul) or mepenzolate (Cantil).

  
  

This list is not complete and other drugs may interact with brompheniramine, dextromethorphan, and pseudoephedrine. 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 Histacol BD Drops resources

• Histacol BD Drops Use in Pregnancy & Breastfeeding
• Histacol BD Drops Drug Interactions
• Histacol BD Drops Support Group
• 0 Reviews for Histacol BD - Add your own review/rating

• Anaplex DMX Suspension MedFacts Consumer Leaflet (Wolters Kluwer)


• Bromdex D Prescribing Information (FDA)


• Bromfed DM Elixir MedFacts Consumer Leaflet (Wolters Kluwer)


• Bromfed DM Prescribing Information (FDA)


• Myphetane DX Prescribing Information (FDA)


• Neo DM Suspension MedFacts Consumer Leaflet (Wolters Kluwer)


• Resperal-DM Drops MedFacts Consumer Leaflet (Wolters Kluwer)

Compare Histacol BD Drops with other medications

• Cough and Nasal Congestion

Where can I get more information?

• Your pharmacist can provide more information about brompheniramine, dextromethorphan, and pseudoephedrine.

carbinoxamine, methscopolamine, and pseudoephedrine

Generic Name: carbinoxamine, methscopolamine, and pseudoephedrine (car bin OX uh meen, meth sko PAW luh meen, and soo doh ee FED rin)

Brand names: Pannaz, Pannaz S, Pseudox M, Nacon

What is carbinoxamine, methscopolamine, and pseudoephedrine?

Carbinoxamine and methscopolamine are antihistamines that reduce the natural chemical histamine in the body. Histamine can produce symptoms of sneezing, itching, watery eyes, and runny nose.

Pseudoephedrine is a decongestant that shrinks blood vessels in the nasal passages. Dilated blood vessels can cause nasal congestion (stuffy nose).

Carbinoxamine, methscopolamine, and pseudoephedrine is used to treat sneezing, runny or stuffy nose, itchy or watery eyes, hives, skin rash, itching, and other symptoms of allergies and the common cold.

Carbinoxamine, methscopolamine, and pseudoephedrine may also be used for purposes other than those listed here.

What is the most important information I should know about carbinoxamine, methscopolamine, and pseudoephedrine?

Always ask a doctor before giving a cough or cold medicine to a child. Death can occur from the misuse of cough and cold medicines in very young children. Do not use a cold medicine if you have used an MAO inhibitor such as isocarboxazid (Marplan), phenelzine (Nardil), rasagiline (Azilect), selegiline (Eldepryl, Emsam), or tranylcypromine (Parnate) within the past 14 days. Serious, life-threatening side effects can occur if you take cold medicine before the MAO inhibitor has cleared from your body. Do not use any other over-the-counter cough, cold, allergy, or sleep medication without first asking your doctor or pharmacist. If you take certain products together you may accidentally take too much of one or more types of medicine. Read the label of any other medicine you are using to see if it contains an antihistamine or decongestant.

What should I discuss with my healthcare provider before taking carbinoxamine, methscopolamine, and pseudoephedrine?

Do not give this medication to a child younger than 2 years old, even if the label has dosing instructions for children this young. Death can occur from the use of carbinoxamine in very young children. Talk with your doctor about other FDA-approved products available for young children with cold or allergy symptoms. Do not use a cold medicine if you have used an MAO inhibitor such as isocarboxazid (Marplan), phenelzine (Nardil), rasagiline (Azilect), selegiline (Eldepryl, Emsam), or tranylcypromine (Parnate) within the past 14 days. Serious, life-threatening side effects can occur if you take cold medicine before the MAO inhibitor has cleared from your body.

Before taking this medication, tell your doctor if you are allergic to carbinoxamine, methscopolamine, or pseudoephedrine, or if you have:

• 
  

  epilepsy or another seizure disorder;

  
  


• 
  

  peripheral vascular disease such as Raynaud's syndrome;

  
  


• 
  

  thyroid problems;

  
  


• 
  

  asthma, emphysema, or chronic obstructive pulmonary disease (COPD);

  
  


• 
  

  diabetes;

  
  


• 
  

  glaucoma;

  
  


• 
  

  an ulcer or an obstruction in the stomach;

  
  


• 
  

  an enlarged prostate or urination problems;

  
  


• 
  

  heart disease or high blood pressure;

  
  


• kidney disease; or


• liver disease.

If you have any of the conditions listed above, you may not be able to take carbinoxamine, methscopolamine, and pseudoephedrine, or you may require a dosage adjustment or special tests during treatment.

FDA pregnancy category C. This medication may be harmful to an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant during treatment. Carbinoxamine, methscopolamine, and pseudoephedrine can pass into breast milk and may harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby.

How should I take carbinoxamine, methscopolamine, and pseudoephedrine?

Take this medication exactly as it was prescribed for you. Do not take the medication in larger amounts, or take it for longer than recommended by your doctor. Follow the directions on your prescription label.

Carbinoxamine, methscopolamine, and pseudoephedrine can be taken with or without food.

Take this medicine with a full glass of water. Do not crush, chew, or break an extended-release tablet. Swallow the pill whole. It is specially made to release medicine slowly in the body. Breaking the pill would cause too much of the drug to be released at one time.

Measure the liquid form of this medicine with a special dose-measuring spoon or cup, not a regular table spoon. If you do not have a dose-measuring device, ask your pharmacist where you can get one.

Call your doctor if you have a fever, or if your symptoms get worse or do not improve after taking this medicine for 7 days.

Store this medication at room temperature away from moisture and heat.

See also: Carbinoxamine, methscopolamine, and pseudoephedrine dosage (in more detail)

What happens if I miss a dose?

Since cold or allergy medicine is usually taken only as needed, you may not be on a dosing schedule. If you are taking the medication regularly, take the missed dose as soon as you remember. If it is almost time for your next dose, skip the missed dose and take the medicine at your next regularly scheduled time. Do not take extra medicine to make up the missed dose.

What happens if I overdose?

Seek emergency medical attention if you think you have used too much of this medicine.

Overdose symptoms may include dry mouth, blurred vision, flushing, nausea, vomiting, hyperactivity, hallucinations, fainting, or seizure (convulsions).

What should I avoid while taking carbinoxamine, methscopolamine, and pseudoephedrine?

This medication can cause side effects that may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be awake and alert. Avoid drinking alcohol. It can increase some of the side effects of this medication. Do not use any other over-the-counter cough, cold, allergy, or sleep medication without first asking your doctor or pharmacist. If you take certain products together you may accidentally take too much of one or more types of medicine. Read the label of any other medicine you are using to see if it contains an antihistamine or decongestant. Cold or allergy medicine, narcotic pain medicine, sleeping pills, muscle relaxers, and medicine for seizures, depression or anxiety can add to sleepiness caused by carbinoxamine, methscopolamine, and pseudoephedrine. Tell your doctor if you need to use any of these other medicines while you are taking this drug.

Carbinoxamine, methscopolamine, and pseudoephedrine 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. Stop using this medication and call your doctor at once if you have any of these serious side effects:

• 
  

  feeling light-headed, fainting;

  
  


• 
  

  urinating less than usual or not at all;

  
  


• 
  

  wheezing, tightness in your chest;

  
  


• 
  

  fast or pounding heartbeat; or

  
  


• 
  

  pale skin, easy bruising or bleeding.

  
  

Continue taking this medication and talk to your doctor if you have any of these less serious side effects:

• 
  

  drowsiness, dizziness;

  
  


• 
  

  lack of coordination;

  
  


• 
  

  upset stomach;

  
  


• 
  

  stuffy nose, chest congestion;

  
  


• 
  

  sleep problems (insomnia);

  
  


• 
  

  feeling restless or excited (especially in children);

  
  


• 
  

  dry mouth or nose; or

  
  


• 
  

  blurred vision.

  
  

Side effects other than those listed here may also occur. Talk to your doctor about any side effect that seems unusual or that is especially bothersome.

Carbinoxamine, methscopolamine, and pseudoephedrine Dosing Information

Usual Adult Dose for Rhinitis:

Syrup: 5 to 10 mL orally four times a day.

Tablet, extended release: 1 tablet orally every 12 hours not to exceed 2 doses per day.

Usual Pediatric Dose for Rhinitis:

6 yrs to 11 yrs:
Syrup: 5 mL orally four times a day.
Tablet, extended release: 0.5 tablet orally every 12 hours not to exceed 2 doses per day.

12 yrs to 17 yrs:
Syrup: 5 to 10 mL orally four times a day.
Tablet, extended release: 1 tablet orally every 12 hours not to exceed 2 doses per day.

What other drugs will affect carbinoxamine, methscopolamine, and pseudoephedrine?

There may be other drugs that can affect carbinoxamine, methscopolamine, and pseudoephedrine. Tell your doctor about all the prescription and over-the-counter medications you use. This includes vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start using a new medication without telling your doctor.

More carbinoxamine, methscopolamine, and pseudoephedrine resources

• Carbinoxamine, methscopolamine, and pseudoephedrine Side Effects (in more detail)
• Carbinoxamine, methscopolamine, and pseudoephedrine Dosage
• Carbinoxamine, methscopolamine, and pseudoephedrine Use in Pregnancy & Breastfeeding
• Carbinoxamine, methscopolamine, and pseudoephedrine Drug Interactions
• Carbinoxamine, methscopolamine, and pseudoephedrine Support Group
• 0 Reviews for Carbinoxamine, methscopolamine, and pseudoephedrine - Add your own review/rating

Compare carbinoxamine, methscopolamine, and pseudoephedrine with other medications

• Rhinitis

Where can I get more information?

• Your pharmacist has additional information about carbinoxamine, methscopolamine, and pseudoephedrine written for health professionals that you may read.

See also: carbinoxamine, methscopolamine, and pseudoephedrine side effects (in more detail)

Nitro-Dur 0.2

Generic Name: nitroglycerin (Transdermal route)

nye-troe-GLIS-er-in

Commonly used brand name(s)

In the U.S.

• Minitran


• Nitrek


• Nitro-Bid


• Nitro-Dur

In Canada

• Nitrodur 0.2


• Nitro-Dur 0.2


• Nitro-Dur 0.3


• Nitrodur 0.4


• Nitro-Dur 0.4


• Nitrodur 0.6


• Nitro-Dur 0.6


• Nitro-Dur 0.8


• Transderm-Nitro


• Trinipatch 0.2


• Trinipatch 0.4


• Trinipatch 0.6

Available Dosage Forms:

• Ointment


• Patch, Extended Release

Therapeutic Class: Antianginal

Chemical Class: Nitrate

Uses For Nitro-Dur 0.2

Nitroglycerin transdermal is used to prevent angina (chest pain) caused by coronary artery disease. It does not work fast enough to relieve the pain of an angina attack that has already started.

Nitroglycerin transdermal belongs to the group of medicines called nitrates. It works by relaxing the blood vessels and increasing the supply of blood and oxygen to the heart while reducing its work load. When used regularly on a long-term basis, this helps prevent angina attacks from occurring.

This medicine is available only with your doctor's prescription.

Before Using Nitro-Dur 0.2

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine 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

Appropriate studies have not been performed on the relationship of age to the effects of nitroglycerin transdermal in the pediatric population. Safety and efficacy have not been established.

Geriatric

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of nitroglycerin transdermal in the elderly. However, elderly patients are more likely to have age-related liver, kidney, or heart problems, which may require caution and an adjustment in the dose for patients receiving nitroglycerin transdermal.

Pregnancy

	Pregnancy Category	Explanation
All Trimesters	C	Animal studies have shown an adverse effect and there are no adequate studies in pregnant women OR no animal studies have been conducted and there are no adequate studies in pregnant women.

Breast Feeding

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

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

• Sildenafil


• Tadalafil


• Vardenafil

Using this medicine 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.

• Alteplase, Recombinant

Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Acetylcysteine


• Aspirin


• Dihydroergotamine


• Pancuronium

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. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Other Medical Problems

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

• Cardioversion (medical heart procedure) or


• Defibrillation (medical heart procedure)—Use with caution. The patch should be removed before having these procedures.

• Congestive heart failure or


• Heart attack, recent or


• Hypertrophic cardiomyopathy (a heart disease) or


• Hypotension (low blood pressure) or


• Hypovolemia (low amount of blood)—Use with caution. May make these conditions worse.

Proper Use of nitroglycerin

This section provides information on the proper use of a number of products that contain nitroglycerin. It may not be specific to Nitro-Dur 0.2. Please read with care.

Use this medicine exactly as directed by your doctor. Do not use more of it, do not use it more often, and do not use it for a longer time than your doctor ordered. It will only work if applied correctly.

This form of nitrate is used to reduce the number of angina attacks over a long time. It will not relieve an attack that has already started because it works too slowly. The ointment and patch forms release medicine gradually to provide an effect for 7 to 10 hours. Check with your doctor if you also need a fast-acting medicine to relieve the pain of an angina attack.

You should use this medicine first thing in the morning and follow the same schedule each day. This medicine works best if you have a "drug-free" period of time every day when you do not use it. Your doctor will schedule your doses during the day to allow for a drug-free time. Follow the schedule of dosing carefully so the medicine will work properly.

This medicine comes with a patient information leaflet. Read and follow the instructions in the leaflet carefully. Ask your doctor if you have any questions.

For patients using the ointment:

• Before applying a new dose of ointment, remove any ointment remaining on the skin from a previous dose. This will allow the fresh ointment to release the nitroglycerin properly.


• This medicine comes with papers to help measure the dose. Use them to measure the length of ointment squeezed from the tube and to apply the ointment to the skin. Do not rub or massage the ointment into the skin. Spread it in a thin, even layer, and cover an area of skin that is the same size each time it is applied.


• Apply the ointment to skin with little or no hair that is free of scars, cuts, or irritation.


• Apply each dose of ointment to a different area of skin to prevent irritation.


• If your doctor has ordered an airtight covering or dressing (such as plastic kitchen wrap) be placed over this medicine, make sure you know how to apply it. Airtight dressings will increase the amount of medicine absorbed through the skin and may cause more side effects. Use them only as directed and check with your doctor if you have any questions about this.

For patients using the patch system:

• Wash your hands with soap and water before and after applying a patch. Do not touch your eyes until after you have washed your hands.


• Do not try to trim or cut the adhesive patch to adjust the dosage. Check with your doctor if you think the medicine is not working as it should.


• Apply the patch to a clean, dry skin area with little or no hair that is free of scars, cuts, or irritation.


• Always remove a previous patch before applying a new one.


• Apply a new patch if the first one becomes loose or falls off.


• Apply each patch to a different area to prevent skin irritation.

Dosing

The dose of this medicine 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 this medicine. 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 angina prevention:
  
  • For transdermal dosage form (ointment):
    
    • Adults—At first, 7.5 milligrams (mg), one-half inch of ointment, two times a day. Apply the first dose in the morning right after you wake up, and the second dose 6 hours later. Your doctor may increase your dose as needed.
    
    
    • Children—Use and dose must be determined by your doctor.
    
    
  
  
  • For transdermal dosage form (skin patch):
    
    • Adults—Apply one patch once a day in the morning. Leave the patch in place for a total of 12 to 14 hours.
    
    
    • Children—Use and dose must be determined by your doctor.
    
    
  
  

Missed Dose

If you miss a dose of this medicine, apply 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.

If you forget to wear or change a patch, put one on as soon as you can. If it is almost time to put on your next patch, wait until then to apply a new patch and skip the one you missed. Do not apply extra patches to make up for a missed dose.

Storage

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

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

After removing a used patch, fold it in half with the sticky sides together. Make sure to dispose of it out of the reach of children and pets.

Precautions While Using Nitro-Dur 0.2

If you will be taking this medicine for a long time, it is very important that your doctor check your progress at regular visits to make sure that this medicine is working properly. Blood tests may be needed to check for unwanted effects.

Do not take sildenafil (Viagra®), tadalafil (Cialis®), or vardenafil (Levitra®) while you are using this medicine. Using these medicines together may cause blurred vision, dizziness, lightheadedness, or fainting. If you are taking these medicines and you experience an angina attack, you must go to the hospital right away.

This medicine may cause headaches. These headaches are a sign that the medicine is working. Do not stop using the medicine or change the time you use it in order to avoid the headaches. If you have severe pain, talk with your doctor.

Dizziness, lightheadedness, or faintness may occur, especially when you get up quickly from a lying or sitting position. Getting up slowly may help.

Dizziness, lightheadedness, or fainting is also more likely to occur if you drink alcohol, stand for long periods of time, exercise, or if the weather is hot. While you are taking this medicine, be careful to limit the amount of alcohol you drink. Also, use extra care during exercise or hot weather or if you must stand for long periods of time.

Do not stop using this medicine without checking with your doctor first. Your doctor may want you to gradually reduce the amount you are using before stopping it completely.

Tell the doctor in charge that you are using this medicine before having a magnetic resonance imaging (MRI) scan. Skin burns may occur at the site where the patch is worn during this procedure. Ask your doctor if the patch should be removed before having an MRI scan. You might need to put on a new patch after the procedure.

Nitro-Dur 0.2 Side Effects

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

More common

• Lightheadedness

Less common

• Arm, back, or jaw pain


• blurred vision


• chest pain or discomfort


• chest tightness or heaviness


• confusion


• dizziness, faintness, or lightheadedness when getting up from a lying or sitting position suddenly


• fainting


• fast or irregular heartbeat


• nausea


• shortness of breath


• sweating


• unusual tiredness or weakness

Rare

• Bluish-colored lips, fingernails, or palms


• dark urine


• difficulty with breathing


• fever


• headache


• pale skin


• rapid heart rate


• sore throat


• unusual bleeding or bruising

Incidence not known

• Blistering, burning, crusting, dryness, or flaking of the skin


• cough


• difficulty with swallowing


• hives


• itching, scaling, severe redness, soreness, or swelling of the skin


• puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue


• skin rash


• wheezing

Get emergency help immediately if any of the following symptoms of overdose occur:

Symptoms of overdose

• Blurred or loss of vision


• bulging soft spot on the head of an infant


• change in consciousness


• change in the ability to see colors, especially blue or yellow


• cold, clammy skin


• disturbed color perception


• double vision


• feeling of constant movement of self or surroundings


• halos around lights


• headache, severe and throbbing


• loss of consciousness


• night blindness


• overbright appearance of lights


• paralysis


• sensation of spinning


• tunnel vision

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:

Rare

• Burning, itching, redness, skin rash, swelling, or soreness at the application site

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.

See also: Nitro-Dur 0.2 side effects (in more detail)

The information contained in the Thomson Reuters Micromedex products as delivered by Drugs.com is intended as an educational aid only. It is not intended as medical advice for individual conditions or treatment. It is not a substitute for a medical exam, nor does it replace the need for services provided by medical professionals. Talk to your doctor, nurse or pharmacist before taking any prescription or over the counter drugs (including any herbal medicines or supplements) or following any treatment or regimen. Only your doctor, nurse, or pharmacist can provide you with advice on what is safe and effective for you.

The use of the Thomson Reuters Healthcare products is at your sole risk. These products are provided "AS IS" and "as available" for use, without warranties of any kind, either express or implied. Thomson Reuters Healthcare and Drugs.com make no representation or warranty as to the accuracy, reliability, timeliness, usefulness or completeness of any of the information contained in the products. Additionally, THOMSON REUTERS HEALTHCARE MAKES NO REPRESENTATION OR WARRANTIES AS TO THE OPINIONS OR OTHER SERVICE OR DATA YOU MAY ACCESS, DOWNLOAD OR USE AS A RESULT OF USE OF THE THOMSON REUTERS HEALTHCARE PRODUCTS. ALL IMPLIED WARRANTIES OF MERCHANTABILITY AND FITNESS FOR A PARTICULAR PURPOSE OR USE ARE HEREBY EXCLUDED. Thomson Reuters Healthcare does not assume any responsibility or risk for your use of the Thomson Reuters Healthcare products.

More Nitro-Dur 0.2 resources

• Nitro-Dur 0.2 Side Effects (in more detail)
• Nitro-Dur 0.2 Use in Pregnancy & Breastfeeding
• Nitro-Dur 0.2 Drug Interactions
• Nitro-Dur 0.2 Support Group
• 0 Reviews for Nitro-Dur 0.2 - Add your own review/rating

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• Angina Pectoris Prophylaxis
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Halobetasol Ointment and Ammonium Lactate Ointment

Pronunciation: HAL-oh-BAY-ta-sol/a-MOE-nee-um LAK-tate
Generic Name: Halobetasol Ointment and Ammonium Lactate
Brand Name: Halonate

Halobetasol Ointment and Ammonium Lactate Ointment is used for:

Treating inflammation and itching caused by certain skin conditions. It may also be used for other conditions as determined by your doctor.

Halobetasol Ointment and Ammonium Lactate Ointment is a kit that contains a topical corticosteroid and a humectant. The corticosteroid reduces skin inflammation (redness, swelling, itching, and irritation). The humectant moisturizes and softens the skin.

Do NOT use Halobetasol Ointment and Ammonium Lactate Ointment if:

• you are allergic to any ingredient in Halobetasol Ointment and Ammonium Lactate Ointment

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

Before using Halobetasol Ointment and Ammonium Lactate Ointment:

Some medical conditions may interact with Halobetasol Ointment and Ammonium Lactate Ointment. 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 or other substances


• if you have rosacea, any kind of skin infection, cuts, scrapes, or lessened blood flow to your skin


• if you have had a recent vaccination; you have measles, tuberculosis (TB), chickenpox, or shingles; or you have had a positive TB test


• if you are taking prednisone or similar medicines

Some MEDICINES MAY INTERACT with Halobetasol Ointment and Ammonium Lactate Ointment. However, no specific interactions with Halobetasol Ointment and Ammonium Lactate Ointment are known at this time.

Ask your health care provider if Halobetasol Ointment and Ammonium Lactate Ointment 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 Halobetasol Ointment and Ammonium Lactate Ointment:

Use Halobetasol Ointment and Ammonium Lactate Ointment as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• To use the halobetasol ointment: Apply a small amount of medicine to the affected area. Gently rub it in until it is evenly distributed. Wash your hands after you apply Halobetasol Ointment and Ammonium Lactate Ointment, unless your hands are part of the treated area.


• Do not bandage or cover the treated skin area unless directed by your doctor.


• To use the ammonium lactate mousse: Keep mousse can in upright position when dispensing. Do not turn can upside down. Apply to dry skin and rub in completely 2 times daily or as directed by your doctor. Wash your hands right away after you apply Halobetasol Ointment and Ammonium Lactate Ointment, unless your hands are a part of the treated area.


• If you miss a dose of Halobetasol Ointment and Ammonium Lactate Ointment, apply 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 apply 2 doses at once.

Ask your health care provider any questions you may have about how to use Halobetasol Ointment and Ammonium Lactate Ointment.

Important safety information:

• Halobetasol Ointment and Ammonium Lactate Ointment is for external use only. Do not get it in your eyes, nose, or mouth. If you get it in any of these areas, rinse right away with cool water.


• Do not use halobetasol on the face, in the groin area, or under the armpits.


• Do NOT use more than the recommended dose or use for longer than 2 weeks without checking with your doctor.


• If your symptoms do not get better within 2 weeks or if they get worse, check with your doctor.


• Talk with your doctor before you receive any vaccine while you are using halobetasol.


• Do not use Halobetasol Ointment and Ammonium Lactate Ointment for other skin conditions at a later time.


• Talk with your doctor before you use any other medicines or cleansers on your skin.


• Overuse of topical products may worsen your condition.


• Ammonium lactate may cause temporary stinging or burning when applied to cracked or scraped skin (eg, after shaving).


• Ammonium lactate may cause you to become sunburned more easily. Avoid the sun, sunlamps, or tanning booths until you know how you react to Halobetasol Ointment and Ammonium Lactate Ointment. Use a sunscreen or wear protective clothing if you must be outside for more than a short time.


• Halobetasol Ointment and Ammonium Lactate Ointment has a corticosteroid in it. Before you start any new prescription or nonprescription medicine, read the label to see if it has a corticosteroid in it too. If it does or if you are not sure, contact your doctor or pharmacist.


• Tell your doctor or dentist that you take Halobetasol Ointment and Ammonium Lactate Ointment before you receive any medical or dental care, emergency care, or surgery.


• Serious side effects may occur if too much of Halobetasol Ointment and Ammonium Lactate Ointment is absorbed through the skin. This may be more likely to occur if you use Halobetasol Ointment and Ammonium Lactate Ointment over a large area of the body. It may also be more likely if you wrap or bandage the area after you apply Halobetasol Ointment and Ammonium Lactate Ointment. The risk is greater in children. Do not use more than the prescribed dose. Contact your doctor right away if you develop unusual weight gain (especially in the face), muscle weakness, increased thirst or urination, confusion, unusual drowsiness, severe or persistent headache, or vision changes. Discuss any questions or concerns with your doctor.


• Corticosteroids may affect growth rate in CHILDREN and teenagers in some cases. They may need regular growth checks while they use Halobetasol Ointment and Ammonium Lactate Ointment.


• Halobetasol Ointment and Ammonium Lactate Ointment should not be used in CHILDREN younger than 12 years old; safety and effectiveness in these children have not been confirmed.


• PREGNANCY and BREAST-FEEDING: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Halobetasol Ointment and Ammonium Lactate Ointment while you are pregnant. It is not known if Halobetasol Ointment and Ammonium Lactate Ointment is found in breast milk after topical use. If you are or will be breast-feeding while you use Halobetasol Ointment and Ammonium Lactate Ointment, check with your doctor. Discuss any possible risks to your baby.

Possible side effects of Halobetasol Ointment and Ammonium Lactate Ointment:

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:

Dryness; itching; mild, temporary burning, irritation, peeling, redness, sensitivity, or stinging.

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, or tongue); acne-like rash; burning, cracking, irritation, or peeling not present before you began using Halobetasol Ointment and Ammonium Lactate Ointment; excessive hair growth; inflamed hair follicles; inflammation around the mouth; muscle weakness; symptoms of high blood sugar (eg, flushing, confusion, drowsiness, increased thirst, increased urination); unusual weight gain, especially in the face.

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.

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 increased thirst or urination; muscle weakness; unusual weight gain, especially in the face.

Proper storage of Halobetasol Ointment and Ammonium Lactate Ointment:

Store Halobetasol Ointment and Ammonium Lactate Ointment at room temperature, between 59 and 86 degrees F (15 and 30 degrees C). Store away from heat, moisture, and light. Do not freeze. Do not store in the bathroom. Keep Halobetasol Ointment and Ammonium Lactate Ointment out of the reach of children and away from pets.

General information:

• If you have any questions about Halobetasol Ointment and Ammonium Lactate Ointment, please talk with your doctor, pharmacist, or other health care provider.


• Halobetasol Ointment and Ammonium Lactate Ointment 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 Halobetasol Ointment and Ammonium Lactate Ointment. 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.

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• Halobetasol Ointment and Ammonium Lactate Use in Pregnancy & Breastfeeding
• Halobetasol Ointment and Ammonium Lactate Drug Interactions
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MOVICOL Plain 13.7g sachet, powder for oral solution

1. Name Of The Medicinal Product

MOVICOL Plain 13.7g sachet, powder for oral solution

2. Qualitative And Quantitative Composition

Each sachet of MOVICOL Plain contains the following active ingredients:

Macrogol 3350	13.1250 g
Sodium Chloride	0.3508 g
Sodium Hydrogen Carbonate	0.1786 g
Potassium Chloride	0.0502 g

The content of electrolyte ions per sachet when made up to 125 ml of solution is as follows:

Sodium	65 mmol/l
Chloride	53 mmol/l
Potassium	5.4 mmol/l
Hydrogen Carbonate	17 mmol/l

For excipients, see Section 6.1.

3. Pharmaceutical Form

Powder for oral solution. Free flowing white powder.

4. Clinical Particulars

4.1 Therapeutic Indications

For the treatment of chronic constipation. MOVICOL Plain is also effective in resolving faecal impaction, defined as refractory constipation with faecal loading of the rectum and/or colon.

4.2 Posology And Method Of Administration

Chronic Constipation

A course of treatment for constipation with MOVICOL Plain does not normally exceed two weeks, although this can be repeated if required.

As for all laxatives, prolonged use is not usually recommended. Extended use may be necessary in the care of patients with severe chronic or resistant constipation, secondary to multiple sclerosis or Parkinson's Disease, or induced by regular constipating medication, in particular opioids and antimuscarinics.

Adults, adolescents and the elderly: 1-3 sachets daily in divided doses, according to individual response.

For extended use, the dose can be adjusted down to 1 or 2 sachets daily.

Children (below 12 years old): Not recommended. Alternative MOVICOL products are available for children.

Faecal impaction

A course of treatment for faecal impaction with MOVICOL Plain does not normally exceed 3 days.

Adults, adolescents and the elderly: 8 sachets daily, all of which should be consumed within a 6 hour period.

Children (below 12 years old): Not recommended. Alternative MOVICOL products are available for children.

Patients with impaired cardiovascular function: For the treatment of faecal impaction the dose should be divided so that no more than two sachets are taken in any one hour.

Patients with renal insufficiency: No dosage change is necessary for treatment of either constipation or faecal impaction.

Administration

Each sachet should be dissolved in 125ml water. For use in faecal impaction 8 sachets may be dissolved in 1 litre water.

4.3 Contraindications

Intestinal perforation or obstruction due to structural or functional disorder of the gut wall, ileus, severe inflammatory conditions of the intestinal tract, such as Crohn's disease and ulcerative colitis and toxic megacolon.

Hypersensitivity to the active ingredients or to any of the excipients.

4.4 Special Warnings And Precautions For Use

Diagnosis of impaction/faecal loading of the rectum should be confirmed by physical or radiological examination of the abdomen and rectum.

Mild adverse drug reactions are possible as indicated in Section 4.8. If patients develop any symptoms indicating shifts of fluid/electrolytes (e.g. oedema, shortness of breath, increasing fatigue, dehydration, cardiac failure) MOVICOL Plain should be stopped immediately and electrolytes measured, and any abnormality should be treated appropriately.

The absorption of other medicinal products could transiently be reduced due to an increase in gastro-intestinal transit rate induced by MOVICOL Plain (see section 4.5).

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

Macrogol raises the solubility of medicinal products that are soluble in alcohol and relatively insoluble in water.

There is a possibility that the absorption of other medicinal products could be transiently reduced during use with MOVICOL Plain (see section 4.4).There have been isolated reports of decreased efficacy with some concomitantly administered medicinal products, e.g. anti-epileptics.

4.6 Pregnancy And Lactation

Pregnancy

There are no or limited amount of data from the use of MOVICOL in pregnant women. Studies in animals have shown reproductive toxicity (see section 5.3).

Breastfeeding

No effects on the breastfed newborn/infant are anticipated since the systemic exposure of the breast-feeding woman to Macrogol 3350 is negligible

MOVICOL can be used during breast-feeding.

4.7 Effects On Ability To Drive And Use Machines

MOVICOL Plain has no influence on the ability to drive and use machines.

4.8 Undesirable Effects

Reactions related to the gastrointestinal tract occur most commonly.

These reactions may occur as a consequence of expansion of the contents of the gastrointestinal tract, and an increase in motility due to the pharmacologic effects of MOVICOL Plain. Mild diarrhoea usually responds to dose reduction.

The frequency of the adverse effects is not known as it cannot be estimated from the available data.

System Order Class	Adverse Event
Immune system disorders	Allergic reactions, including anaphylaxis, angioedema, dyspnoea, rash, erythema, urticaria and pruritus.
Metabolism and nutrition disorders	Electrolyte disturbances, particularly hyperkalaemia and hypokalaemia.
Nervous system disorders	Headache
Gastrointestinal disorders	Abdominal pain, diarrhoea, vomiting, nausea, dyspepsia, abdominal distension, borborygmi, flatulence, anal discomfort.
General disorders and administration site conditions	Peripheral oedema

4.9 Overdose

Severe pain or distension can be treated by nasogastric aspiration. Extensive fluid loss by diarrhoea or vomiting may require correction of electrolyte disturbances.

5. Pharmacological Properties

5.1 Pharmacodynamic Properties

Pharmacotherapeutic group: Osmotically acting laxatives.

ATC code: A06A D65

Macrogol 3350 acts by virtue of its osmotic action in the gut, which induces a laxative effect. Macrogol 3350 increases the stool volume, which triggers colon motility via neuromuscular pathways. The physiological consequence is an improved propulsive colonic transportation of the softened stools and a facilitation of the defaecation. Electrolytes combined with macrogol 3350 are exchanged across the intestinal barrier (mucosa) with serum electrolytes and excreted in faecal water without net gain or loss of sodium, potassium and water.

For the indication of faecal impaction controlled comparative studies have not been performed with other treatments (e.g. enemas). In a non-comparative study in 27 adult patients, MOVICOL cleared the faecal impaction in 12/27 (44%) after 1 day's treatment; 23/27 (85%) after 2 days' treatment and 24/27 (89%) at the end of 3 days.

Clinical studies in the use of MOVICOL in chronic constipation have shown that the dose needed to produce normal formed stools tends to reduce over time. Many patients respond to between 1 and 2 sachets a day, but this dose should be adjusted depending on individual response.

5.2 Pharmacokinetic Properties

Macrogol 3350 is unchanged along the gut. It is virtually unabsorbed from the gastro-intestinal tract. Any macrogol 3350 that is absorbed is excreted via the urine.

5.3 Preclinical Safety Data

Preclinical studies provide evidence that macrogol 3350 has no significant systemic toxicity potential, based on conventional studies of pharmacology, repeated dose toxicity and genotoxicity.

Indirect embryofoetal effects were noted in the rabbit at clinically relevant doses. Treatment caused an increased incidence of malrotated limbs, reduction in foetal and placental weights, reduced foetal viability and abortions at maternally toxic doses. The safety margin was 1.1 x the maximum recommended dose for faecal impaction in a 60 kg adult for malrotated limb and 2.9 x below the maximum recommended dose for the remaining findings. Rabbits are sensitive animal test species to the effects of GI acting substances and the studies were conducted under exaggerated conditions with administered high dose volumes. The relevance of these findings to humans is unknown.

There are no long-term animal toxicity or carcinogenicity studies involving macrogol 3350, although there are toxicity studies using high levels of orally administered high molecular weight macrogols that provide evidence of safety at the recommended therapeutic dose.

6. Pharmaceutical Particulars

6.1 List Of Excipients

None

6.2 Incompatibilities

None are known.

6.3 Shelf Life

3 years.

Reconstituted solution: 6 hours.

6.4 Special Precautions For Storage

Sachet: Do not store above 25°C.

Reconstituted solution: Store at 2-8°C (in a refrigerator and covered)

6.5 Nature And Contents Of Container

Each sachet contains 13.7 g of powder.

Sachet: laminate consisting of four layers: low density polyethylene, aluminium, low density polyethylene and paper.

Pack sizes: boxes of 6, 8, 10, 20, 30, 40, 50, 60 or 100 sachets.

Not all pack sizes may be marketed

6.6 Special Precautions For Disposal And Other Handling

Any unused solution should be discarded within 6 hours

7. Marketing Authorisation Holder

Norgine BV

Hogehilweg 7

1101 CA Amsterdam ZO

The Netherlands

8. Marketing Authorisation Number(S)

PL 20142/0004

9. Date Of First Authorisation/Renewal Of The Authorisation

12 September 2006 / 25 January 2011

10. Date Of Revision Of The Text

05/05/2011

Stannous Fluoride Rinse

Pronunciation: STAN-us FLOOR-ide
Generic Name: Stannous Fluoride
Brand Name: Examples include Gel-Kam and Perio Med

Stannous Fluoride Rinse is used for:

Preventing cavities.

Stannous Fluoride Rinse is a fluoride rinse. It works by strengthening the teeth and decreasing the effects of acid and bacteria on the teeth.

Do NOT use Stannous Fluoride Rinse if:

• you are allergic to any ingredient in Stannous Fluoride Rinse

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

Before using Stannous Fluoride Rinse:

Some medical conditions may interact with Stannous Fluoride Rinse. 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 joint pain or an ulcer

Some MEDICINES MAY INTERACT with Stannous Fluoride Rinse. However, no specific interactions with Stannous Fluoride Rinse are known at this time.

Ask your health care provider if Stannous Fluoride Rinse 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 Stannous Fluoride Rinse:

Use Stannous Fluoride Rinse as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• Use Stannous Fluoride Rinse after brushing your teeth, as directed by your doctor.


• Stannous Fluoride Rinse must be mixed with water before you use it. To mix Stannous Fluoride Rinse, pour it to the 1/8 fluid oz mark in the measuring cup provided. Add water to the 1 fluid oz mark and mix.


• Use Stannous Fluoride Rinse immediately after mixing.


• Place half of the mixture into the mouth. Swish well for 1 minute, then spit. Repeat with the remaining mixture.


• Do not swallow Stannous Fluoride Rinse.


• Do not eat or drink for 30 minutes after using Stannous Fluoride Rinse.


• If you miss a dose of Stannous Fluoride Rinse, 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 Stannous Fluoride Rinse.

Important safety information:

• Do NOT use more than the recommended dose or more often than prescribed without checking with your dentist.


• Stannous Fluoride Rinse may cause staining of the teeth. Proper brushing may prevent this. The staining is not harmful or permanent, and can be removed by your dentist. Tell your dentist if you notice tooth staining.


• Be sure to show CHILDREN how to use Stannous Fluoride Rinse in order to decrease the chance of swallowing it.


• Check with your doctor before you use Stannous Fluoride Rinse in CHILDREN younger than 12 years old.


• PREGNANCY AND BREAST-FEEDING: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Stannous Fluoride Rinse while you are pregnant. It is not known if Stannous Fluoride Rinse is found in breast milk. If you are or will be breast-feeding while you use Stannous Fluoride Rinse, check with your doctor. Discuss any possible risks to your baby.

Possible side effects of Stannous Fluoride Rinse:

All medicines may cause side effects, but many people have no, or minor, side effects. When used in small doses, no COMMON side effects have been reported with Stannous Fluoride Rinse. 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, or tongue).

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.

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 Stannous Fluoride Rinse:

Store Stannous Fluoride Rinse at room temperature, between 68 and 77 degrees F (20 and 25 degrees C). Store away from heat, moisture, and light. Do not freeze or expose to extreme heat. Keep tightly closed when not in use. Keep Stannous Fluoride Rinse out of the reach of children and away from pets.

General information:

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


• Stannous Fluoride Rinse 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 Stannous Fluoride Rinse. 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 Stannous Fluoride resources

• Stannous Fluoride Use in Pregnancy & Breastfeeding
• Stannous Fluoride Support Group
• 3 Reviews for Stannous Fluoride - Add your own review/rating

Compare Stannous Fluoride with other medications

• Prevention of Dental Caries