There are currently no drugs listed for "Spina bifida".
Definition of Spina bifida:
Spina bifida (SB) is a neural tube defect (a disorder involving incomplete development of the brain, spinal cord, and/or their protective coverings) caused by the failure of the fetus's spine to close properly during the first month of pregnancy.Harvard Health Guide:
Generic Name: methyldopa (METH il DOE pa)
Brand Names: Aldomet
Methyldopa lowers blood pressure by decreasing the levels of certain chemicals in your blood. This allows your blood vessels (veins and arteries) to relax (widen) and your heart to beat more slowly and easily.
Methyldopa is used to treat hypertension (high blood pressure).
Methyldopa may also be used for purposes not listed in this medication guide.
Before you take methyldopa, tell your doctor if you have a history of liver disease, kidney disease (or if you are on dialysis), heart disease, angina (chest pain), or a history of heart attack or stroke.
Avoid getting up too fast from a sitting or lying position, or you may feel dizzy. Get up slowly and steady yourself to prevent a fall.
Your blood pressure will need to be checked often. To be sure this medication is not causing harmful effects, your liver function may need to be tested. Visit your doctor regularly.
liver disease (especially cirrhosis); or
a history of liver problems caused by taking methyldopa.
To make sure you can safely take methyldopa, tell your doctor if you have any of these other conditions:
kidney disease (or if you are on dialysis);
a history of liver disease;
heart disease, angina (chest pain); or
a history of heart attack or stroke.
Take exactly as prescribed by your doctor. Do not take in larger or smaller amounts or for longer than recommended. Follow the directions on your prescription label.
This medication can cause unusual results with certain medical tests. Tell any doctor who treats you that you are using methyldopa.
Your blood pressure will need to be checked often. To be sure this medication is not causing harmful effects, your liver function may need to be tested. Visit your doctor regularly.
See also: Methyldopa dosage (in more detail)
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.
Overdose symptoms may include extreme drowsiness, vomiting, slow heartbeats, or fainting.
Avoid getting up too fast from a sitting or lying position, or you may feel dizzy. Get up slowly and steady yourself to prevent a fall.
slow heart rate;
pale or yellowed skin, fever, confusion or weakness;
nausea, upper stomach pain, itching, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes);
skin rash, bruising, severe tingling, numbness, pain, muscle weakness;
feeling short of breath, even with mild exertion;
swelling in your hands, ankles, or feet;
easy bruising, unusual bleeding (nose, mouth, vagina, or rectum), purple or red pinpoint spots under your skin; or
muscle movements you cannot control.
Less serious side effects may include:
weight gain;
drowsiness, dizziness, weakness;
headache;
joint pain or swelling, muscle pain;
dry mouth;
vomiting, stomach pain;
swollen or "black" tongue;
constipation, diarrhea, bloating, gas;
depressed mood, unusual thoughts, nightmares;
numbness or tingly feeling;
stuffy nose;
missed menstrual periods; or
breast swelling or discharge.
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.
Usual Adult Dose for Hypertension:
Initial dose: 250 mg orally 2-3 times a day or 250 to 500 mg IV over 30 to 60 minutes every 6 hours, up to a maximum of 3 g/day.
Maintenance dose: 500 mg to 2 g orally divided in 2 to 4 doses, up to a maximum of 3 g/day.
Usual Adult Dose for Hypertensive Emergency:
250 to 500 mg IV over 30 to 60 minutes every 6 hours up to a maximum of 1 g every 6 hours or 4 g/day. Switch to the oral route at the same dosage once blood pressure is under control.
Tell your doctor about all other medicines you use, especially:
ferrous gluconate, a type of iron (Ferate, Fergon);
ferrous sulfate, a type of iron (Feosol, Fer-in-Sol, Feratab, and others);
lithium (Eskalith, Lithobid); or
any other blood pressure medications.
This list is not complete and other drugs may interact with methyldopa. 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.
See also: methyldopa side effects (in more detail)
Preventing or treating symptoms of hay fever and other upper respiratory allergies or the common cold, such as runny nose, sneezing, itching of the nose and throat, and itchy, watery eyes, and relieving cough. It may also be used for other conditions as determined by your doctor.
Clemastine is an antihistamine. It works by blocking the action of histamine, reducing the symptoms of an allergic reaction.
Contact your doctor or health care provider right away if any of these apply to you.
Some medical conditions may interact with Clemastine. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:
Some MEDICINES MAY INTERACT with Clemastine. Tell your health care provider if you are taking any other medicines, especially any of the following:
This may not be a complete list of all interactions that may occur. Ask your health care provider if Clemastine 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.
Use Clemastine as directed by your doctor. Check the label on the medicine for exact dosing instructions.
Ask your health care provider any questions you may have about how to use Clemastine.
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:
Dizziness; drowsiness; dry mouth, throat, and nose; excitability; thickening of mucus in nose or throat.
Severe allergic reactions (rash; hives; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); convulsions; fast heartbeat or pounding in the chest; decreased alertness; hallucinations; tremor; wheezing.
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: Clemastine side effects (in more detail)
Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately. Symptoms may include coma; excitement; hallucinations; loss of consciousness; muscle twitching; seizures; tremor; weakness.
Store Clemastine at room temperature, between 68 and 77 degrees F (20 and 25 degrees C), or according to directions on the package label. Store in the original package or container. Store away from heat, moisture, and light. Do not store in the bathroom. Keep Clemastine out of the reach of children and away from pets.
This information is a summary only. It does not contain all information about Clemastine. 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.
Treating certain children or adults when the body does not produce enough growth hormone. It is also used to treat certain children who are not growing normally because of Turner syndrome or certain other conditions (eg, idiopathic short stature, short stature homeobox-containing gene [SHOX] deficiency). It may also be used for other conditions as determined by your doctor.
Humatrope Cartridge is a growth hormone. It works by stimulating growth in patients who do not make enough natural growth hormone.
Contact your doctor or health care provider right away if any of these apply to you.
Some medical conditions may interact with Humatrope Cartridge. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:
Some MEDICINES MAY INTERACT with Humatrope Cartridge. Tell your health care provider if you are taking any other medicines, especially any of the following:
This may not be a complete list of all interactions that may occur. Ask your health care provider if Humatrope Cartridge 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.
Use Humatrope Cartridge as directed by your doctor. Check the label on the medicine for exact dosing instructions.
Ask your health care provider any questions you may have about how to use Humatrope Cartridge.
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:
Back pain; headache; increased cough; mild flu-like symptoms; mild swelling (eg, of the hands or feet); muscle or joint pain; redness or itching at the injection site; sore throat; stuffy or runny nose.
Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); breast enlargement in males; burning, tingling, or numbness; change in appearance or size of a mole; chest pain or discomfort; confusion; ear pain, discharge, or discomfort; fever; hearing problems; hip or knee pain; limp; nausea or vomiting; new growth on the skin; one-sided weakness; persistent or severe cough or sore throat; severe or persistent muscle or joint pain; severe or persistent stomach or back pain; severe or persistent swelling of the hands, ankles, or feet; shortness of breath; slurred speech; snoring or irregular breathing during sleep; sudden, severe, or persistent headache or dizziness; symptoms of high blood sugar (eg, increased thirst, hunger, or urination; unusual weakness); thickened or hardened skin at the injection site; trouble breathing; unusual bruising; vision changes.
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: Humatrope side effects (in more detail)
Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately. Symptoms may include swelling of the hands, ankles, or feet; symptoms of high or low blood sugar (eg, dizziness; fainting; fast breathing; fast heartbeat; flushing; increased sweating; increased thirst, hunger, or urination; vision changes; unusual weakness).
Store new (unopened) cartridges in the refrigerator, between 36 and 46 degrees F (2 and 8 degrees C). Do not freeze. Protect from light. Do not use Humatrope Cartridge past the expiration date on the product label.
After mixing, store cartridges in the refrigerator, between 36 and 46 degrees F (2 and 8 degrees C). Do not freeze. Store without the needle attached. Throw away cartridges after 28 days, even if they still contain medicine.
Contact your pharmacist if you have any questions about how to properly store Humatrope Cartridge. Keep Humatrope Cartridge out of the reach of children and away from pets.
This information is a summary only. It does not contain all information about Humatrope Cartridge. 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.
Class: Sulfonylureas
VA Class: HS502
Molecular Formula: C24H34N4O5S
CAS Number: 93479-97-1
Brands: Amaryl, Avandaryl
Special Alerts:
[UPDATED 02/04/2011] FDA notified healthcare professionals and patients that information on the cardiovascular risks (including heart attack) of rosiglitazone has been added to the physician labeling and patient Medication Guide. This information was first announced by FDA on September 23, 2010 as part of new restrictions for prescribing and use of this drug.
Rosiglitazone is sold as a single-ingredient product under the brand name Avandia. Rosiglitazone is also sold as a combination product under the brand name Avandamet (contains rosiglitazone and metformin) and under the brand name Avandaryl (contains rosiglitazone and glimepiride).
In addition to describing the cardiovascular risks, the drug labels have been revised to state that rosiglitazone and rosiglitazone-containing medicines should only be used:
In patients already being treated with these medicines
In patients whose blood sugar cannot be controlled with other anti-diabetic medicines and who, after consulting with their healthcare professional, do not wish to use pioglitazone-containing medicines (Actos, Actoplus Met, Actoplus Met XR, or Duetact).
[Posted 09/23/2010] ISSUE: FDA notified healthcare professionals and patients that it will significantly restrict the use of the diabetes drug rosiglitazone (Avandia) to patients with Type 2 diabetes who cannot control their diabetes on other medications. These new restrictions are in response to data that suggest an elevated risk of cardiovascular events, such as heart attack and stroke, in patients treated with rosiglitazone
BACKGROUND: Rosiglitazone is in a class of drugs known as thiazolidinediones, or TZDs. It is intended to be used in conjunction with diet and exercise to improve glucose (blood sugar) control in patients with Type 2 diabetes mellitus. Rosiglitazone also is available in combination with other diabetes medications, metformin under the brand name Avandamet or glimepiride under the brand name Avandaryl.
RECOMMENDATION: FDA will require that GSK develop a restricted access program for rosiglitazone under a risk evaluation and mitigation strategy, or REMS. Under the REMS, rosiglitazone will be available to new patients only if they are unable to achieve glucose control on other medications and are unable to take pioglitazone (Actos), the only other drug in this class. Current users of rosiglitazone who are benefiting from the drug will be able to continue using the medication if they choose to do so.
Doctors will have to attest to and document their patients' eligibility; patients will have to review statements describing the cardiovascular safety concerns associated with this drug and acknowledge they understand the risks. The agency anticipates that the REMS will limit use of rosiglitazone significantly. For more information visit the FDA website at: and .
Antidiabetic agent; sulfonylurea.1 53
Used alone or in combination with one or more other oral antidiabetic agents or insulin as an adjunct to diet and exercise for the management of type 2 (noninsulin-dependent) diabetes mellitus (NIDDM).1 5 54 100 101 102 103 104 105 106 107 c
Pending revision, the material in this section should be considered in light of more recently available information in the MedWatch notification at the beginning of this monograph.
Use fixed combination with rosiglitazone (Avandaryl) when treatment with rosiglitazone and glimepiride is appropriate.c Safety and efficacy of switching to the fixed combination of glimepiride and rosiglitazone in patients with type 2 diabetes mellitus previously receiving other oral antidiabetic agents not established.114
Metformin is the preferred initial oral antidiabetic agent for patients with type 2 diabetes mellitus.118 Sulfonylureas are one of several second-line classes of agents used with other antidiabetic agents (e.g., metformin) in patients who are inadequately controlled on their current therapy.118
Not effective as sole therapy in patients with type 1 diabetes mellitus or diabetic acidosis, ketosis, or coma; insulin is necessary.1 14 28 29 42 45 114 d
Not routinely recommended in hospitalized patients with diabetes mellitus.31 Long duration of action precludes rapid dosage adjustments.1 31 Increased risk of hypoglycemia in hospitalized diabetic patients with irregular eating patterns.31
Adjust dosage according to tolerance and fasting glucose determinations.1 114 Monitor regularly (e.g., fasting blood or plasma glucose determinations) to determine therapeutic response and minimum effective dosage.1 114 Undertake any change in therapy with care and monitor appropriately.114 Monitor glycosylated hemoglobin (hemoglobin A1c, HbA1c) every 3–6 months to determine the patient’s continued response to therapy.1 114
Use lowest effective dosage (either as monotherapy or combined with metformin hydrochloride or insulin) to reduce both fasting glucose concentrations and HbA1c values to normal or near normal.1 17 18 24 31 28
Pending revision, the material in this section should be considered in light of more recently available information in the MedWatch notification at the beginning of this monograph.
If inadequate glycemic control and/or secondary failure occurs during monotherapy with glimepiride, initiate add-on therapy with metformin, insulin, or rosiglitazone (e.g., as the fixed combination of glimepiride and rosiglitazone).1 114 With concomitant glimepiride and metformin therapy, adjust dosage to the minimum effective level for each drug.1
When initiating therapy, consider the benefit-to-risk ratio of monotherapy versus combination therapy.c
Pending revision, the material in this section should be considered in light of more recently available information in the MedWatch notification at the beginning of this monograph.
Administer glimepiride alone or in fixed combination with rosiglitazone once daily with the first main meal.1 5 6 114 d
If a dose is missed, take the missed dose as soon as it is remembered.d If the missed dose is remembered at the time of the next dose, skip missed dose and resume the regular schedule.d Do not double dose to replace missed dose.d
Dispensing errors have occurred involving Amaryl (the trade name for glimepiride) and Reminyl (the former trade name for galantamine hydrobromide, an acetylcholinesterase inhibitor used for treatment of Alzheimer’s dementia).111 112 Serious adverse events (e.g., severe hypoglycemia, death) have occurred because glimepiride was used in patients for whom the drug was not prescribed.111 Exercise extra care in ensuring the accuracy of both oral and written prescriptions for these drugs.111 112 To avoid future dispensing errors, the manufacturer of Reminyl changed the trade name for galantamine hydrobromide from Reminyl to Razadyne.113
Pending revision, the material in this section should be considered in light of more recently available information in the MedWatch notification at the beginning of this monograph.
With the fixed combination of glimepiride and rosiglitazone maleate, dosage of rosiglitazone component expressed in terms of rosiglitazone.114
Initially, 1–2 mg once daily for previously untreated patients or patients transferred from other antidiabetic agents.1 In patients receiving 1 mg daily, increase dosage to 2 mg daily after 1–2 weeks if adequate glycemic control has not been achieved.53 Increase dosage in increments of no more than 2 mg daily at 1- to 2-week intervals up to a maximum of 8 mg once daily.1 Usual maintenance dosage is 1–4 mg once daily.1 53
Maximum initial dosage should not exceed 2 mg once daily.1
Pending revision, the material in this section should be considered in light of more recently available information in the MedWatch notification at the beginning of this monograph.
Previously untreated patients: Usual initial dosage is 1 mg of glimepiride and 4 mg of rosiglitazone once daily.120
Patients inadequately controlled on sulfonylurea or rosiglitazone monotherapy: Initially, 1 or 2 mg of glimepiride and 4 mg of rosiglitazone once daily.114
In patients previously receiving thiazolidinedione monotherapy, allow approximately 1–2 weeks to assess therapeutic response to newly initiated glimepiride component before adjusting dosage.114 If additional glycemic control is needed after 1–2 weeks, increase dosage of the glimepiride component in increments of ≤2 mg.c Assess response to increase in glimepiride component after 1–2 weeks to determine need for further dosage adjustment.c If additional glycemic control is needed, increase dosage of glimepiride and rosiglitazone until adequate glycemic control is achieved or maximum daily dosage of 8 mg of rosiglitazone and 4 mg of glimepiride is reached.c
In patients previously receiving sulfonylurea monotherapy, allow 2 weeks to observe reduction in blood glucose concentrations and 2–3 months to observe full therapeutic response to newly initiated rosiglitazone component.114 If additional glycemic control is needed after 8–12 weeks, increase dosage of the rosiglitazone component.c If additional glycemic control is needed 2–3 months after an increase in rosiglitazone component, increase dosage of glimepiride and rosiglitazone.c
For replacement of concurrent therapy with the drugs given as separate tablets, dosage of the fixed combination is based on the patient’s current dosages of glimepiride and/or rosiglitazone.114
If hypoglycemia occurs, reduce dosage of glimepiride component.114
Initially, 8 mg once daily and a low insulin dosage in patients whose fasting plasma or serum glucose concentration exceeds 150 mg/dL despite appropriate oral antidiabetic monotherapy, diet, and exercise.1 31
Adjust insulin dosage upward at approximately weekly intervals until adequate glycemic control is achieved.1 31 53 Periodic adjustments in insulin dosage may be necessary during continued combination therapy.1
Initially, 1–2 mg once daily.1 1 2 May discontinue other sulfonylurea agents immediately.1 2 3 96 During transfer from chlorpropamide (a sulfonylurea with a long elimination half-life), monitor closely for hypoglycemia during the initial 1–2 weeks of the transition period.1
The initial dosage of glimepiride during transfer from other therapy should not exceed 2 mg daily.1
Glimepiride monotherapy: Maximum 8 mg daily.1
Fixed combination with rosiglitazone: Maximum 4 mg of glimepiride and 8 mg of rosiglitazone daily.114
Glimepiride monotherapy: Initially, 1 mg once daily.1 Conservative initial and maintenance dosages recommended.1
Fixed-combination preparation with rosiglitazone: Initially, 1 mg of glimepiride and 4 mg of rosiglitazone daily.114 Conservative initial and maintenance dosages recommended in patients with mild hepatic impairment; these individuals may be particularly sensitive to the hypoglycemic effects of glimepiride.c Do not initiate therapy with fixed combination of glimepiride and rosiglitazone in patients with clinical evidence of active liver disease or elevated serum aminotransferase concentrations (ALT >2.5 times ULN).114
Glimepiride monotherapy: Initially, 1 mg once daily.1 Titrate dosage upward based on fasting glucose concentrations.1 Dosages >1 mg daily may not be required if Clcr <22 mL/minute.1 8
Fixed-combination preparation with rosiglitazone: Initially, 1 mg of glimepiride and 4 mg of rosiglitazone daily.114 Conservative initial and maintenance dosages recommended; individuals with renal impairment may be particularly sensitive to the hypoglycemic effects of glimepiride.c
Geriatric individuals may be particularly sensitive to the hypoglycemic effects of glimepiride.1 114 c
Glimepiride monotherapy: Initially, 1 mg once daily.1 Titrate dosage upward with care.1 114 Conservative initial and maintenance dosages recommended.1 53 114
Fixed-combination preparation with rosiglitazone: Initially, 1 mg of glimepiride and 4 mg of rosiglitazone daily.114 Conservative initial and maintenance dosages recommended.c
Fixed-combination preparation with rosiglitazone: Initially, 1 mg of glimepiride and 4 mg of rosiglitazone daily.114 Conservative initial and maintenance dosages recommended; these individuals may be particularly sensitive to the hypoglycemic effects of glimepiride.c
These individuals may be particularly sensitive to the hypoglycemic effects of glimepiride.1 c
Glimepiride monotherapy: Initially, 1 mg once daily.1 Conservative initial and maintenance dosages recommended.1
Fixed-combination preparation with rosiglitazone: Initially, 1 mg of glimepiride and 4 mg of rosiglitazone daily.114 Conservative initial and maintenance dosages recommended.c
Known hypersensitivity to glimepiride or any ingredient in formulation.1 114 d
Diabetic ketoacidosis, with or without coma.1 114
Increased cardiovascular mortality reported with certain other antidiabetic agents (i.e., tolbutamide, phenformin).1 99 114 However, the American Diabetes Association (ADA) considers the benefits of intensive glycemic control with insulin or sulfonylureas to outweigh the risks overall.31 58 64 99
Possible severe hypoglycemia, especially in geriatric, debilitated, or malnourished patients and those with adrenal, pituitary, hepatic, or renal insufficiency.1 114 Increased risk of hypoglycemia with strenuous exercise, alcohol ingestion, insufficient caloric intake, or use in combination with other oral antidiabetic agents (e.g., rosiglitazone, metformin).1 114
Hypoglycemia may be difficult to recognize in geriatric patients and in those receiving β-adrenergic blocking agents.1 114
Appropriate patient selection and careful dosing are important to avoid glimepiride-induced hypoglycemia.1 114
Possible loss of glycemic control during periods of stress (e.g., fever, trauma, infection, surgery); administration of insulin may be required.1 114 May reinstitute oral antidiabetic therapy after an acute episode has resolved.114
Efficacy of therapy may decrease over time (secondary failure).1 Addition of metformin or insulin to therapy may be required.1 54 (See Diabetes Mellitus under Uses.)
Pending revision, the material in this section should be considered in light of more recently available information in the MedWatch notification at the beginning of this monograph.
When used in fixed-combination with rosiglitazone, consider the cautions, precautions, and contraindications associated with rosiglitazone.114
Category C.1 114
Many experts recommend use of insulin during pregnancy to maintain optimum control of blood glucose concentrations.1 114 c
Distributed into milk in rats; other sulfonylureas distributed into human milk.1 Use not recommended.1 114 If oral antidiabetic therapy discontinued and diet alone is inadequate for optimal glycemic control, consider institution of insulin.1 114
Glimepiride: Safety and efficacy not established in children <16 years of age.1 53
Fixed combination with rosiglitazone: Safety and efficacy not established in children <18 years of age.114 d
ADA states that use of oral antidiabetic agents may be considered in children with type 2 diabetes mellitus because of the greater compliance and convenience and lack of evidence demonstrating better efficacy of insulin for type 2 diabetes mellitus.93
No substantial differences in safety, efficacy, or pharmacokinetics relative to younger adults, but increased sensitivity cannot be ruled out.1
Possible increased risk of adverse effects due to age-related decreases in renal function.1 Renal function monitoring recommended, and care should be taken in dosage selection.1 (See Geriatric Patients under Dosage and Administration.)
Increased risk of hypoglycemia; may be difficult to recognize in geriatric patients.1
Monitor liver function in all patients receiving glimepiride in fixed combination with rosiglitazone prior to initiation of therapy and periodically thereafter.114 Monitor more frequently if used in patients with mild hepatic impairment (ALT ≤2.5 times the ULN).114 Recheck ALT as soon as possible if ALT increases to >3 times the ULN.114 Discontinue therapy with fixed combination if ALT remains elevated at >3 times ULN.114 Check liver function if manifestations suggestive of hepatic dysfunction (e.g., unexplained nausea, vomiting, abdominal pain, fatigue, anorexia, dark urine) occur.114 Decision to continue therapy pending results of laboratory tests should be guided by clinician judgment.114 Discontinue if jaundice develops.114
Increased risk of hypoglycemia; conservative dosing recommended.1 (See Hepatic Impairment under Dosage and Administration.)
Decreased clearance.1
Increased risk of hypoglycemia; conservative dosing recommended.1 (See Renal Impairment under Dosage and Administration.)
Dizziness, asthenia, headache, nausea.1
Metabolized by CYP2C9.1 114
Pharmacokinetic interactions likely with drugs that are inhibitors and inducers of CYP2C9; possible alteration in metabolism of glimepiride.1 114
Potential pharmacokinetic interaction (increased hypoglycemic effect).1 114 (See Specific Drugs under Interactions.)
Close observation recommended when initiating or discontinuing concomitant therapy with a highly protein-bound drug.1
Potential pharmacologic interaction (loss of glycemic control).1 114
Close observation recommended when initiating or discontinuing concomitant therapy.1 114
Drug | Interaction | Comments |
|---|---|---|
ACE inhibitors (e.g., ramipril) | No evidence of clinically important adverse interactions in clinical studies1 114 | |
Antifungals, oral (i.e., miconazole) | Increased hypoglycemic effect; severe hypoglycemia reported1 114 | Not known whether interaction occurs with IV, topical, or vaginal antifungal dosage forms1 114 |
β-Adrenergic blocking agents (e.g., propranolol) | Highly protein-bound drugs may displace glimepiride from plasma proteins and potentiate hypoglycemic effect1 114 Increased peak plasma concentrations and half-life and decreased clearance of glimepiride with concomitant propranolol1 114 | Observe carefully for hypoglycemic effects when initiating concomitant therapy or loss of glycemic control when discontinuing such therapy1 114 Exercise caution with concomitant therapy114 No evidence of clinically important adverse interactions in clinical studies1 114 |
Calcium-channel blockers | No evidence of clinically important adverse interactions in clinical studies1 | |
Chloramphenicol | Highly protein-bound drugs may displace glimepiride from plasma proteins and potentiate hypoglycemic effect1 114 | Observe carefully for hypoglycemic effects when initiating concomitant therapy or loss of glycemic control when discontinuing such therapy1 114 |
Corticosteroids | Potential for decreased hypoglycemic effect1 114 | Observe carefully for loss of glycemic control when initiating concomitant therapy or hypoglycemic effects when discontinuing such therapy1 114 |
Coumarin anticoagulants (e.g., warfarin) | Highly protein-bound drugs may displace glimepiride from plasma proteins and potentiate hypoglycemic effect1 114 No change in warfarin protein binding with concomitant administration but slight decrease in pharmacodynamic response1 114 | Observe carefully for hypoglycemic effects when initiating concomitant therapy or loss of glycemic control when discontinuing such therapy1 114 No clinically important pharmacokinetic interaction with warfarin reported1 |
Diuretics (e.g., thiazides) | Potential for decreased hypoglycemic effect1 114 | Observe carefully for loss of glycemic control when initiating concomitant therapy or hypoglycemic effects when discontinuing such therapy1 114 |
Estrogens | Potential for decreased hypoglycemic effect1 114 | Observe carefully for loss of glycemic control when initiating concomitant therapy or hypoglycemic effects when discontinuing such therapy1 114 No evidence of clinically important adverse interactions in clinical studies1 |
Fluconazole | Increased AUC and half-life of glimepiridea | Concomitant use may increase the risk of hypoglycemiaa |
H2-receptor antagonists (e.g., cimetidine, ranitidine) | No clinically important pharmacokinetic interactions observed.1 114 | |
HMG-CoA reductase inhibitors (statins) | No evidence of clinically important adverse interactions in clinical studies1 | |
Hormonal contraceptives | Potential for decreased hypoglycemic effect1 114 | Observe carefully for loss of glycemic control when initiating concomitant therapy or hypoglycemic effects when discontinuing such therapy1 114 |
Isoniazid | Potential for decreased hypoglycemic effect1 114 | Observe carefully for loss of glycemic control when initiating concomitant therapy or hypoglycemic effects when discontinuing such therapy1 114 |
MAO inhibitors | Highly protein-bound drugs may displace glimepiride from plasma proteins and potentiate hypoglycemic effect114 | Observe carefully for hypoglycemic effects when initiating concomitant therapy or loss of glycemic control when discontinuing such therapy1 114 |
Niacin | Potential for decreased hypoglycemic effect1 114 | Observe carefully for loss of glycemic control when initiating concomitant therapy or hypoglycemic effects when discontinuing such therapy1 114 |
NSAIAs | Potential for increased hypoglycemic effect1 114 No evidence of clinically important adverse interactions in clinical studies1 | Observe carefully for hypoglycemic effects when initiating concomitant therapy or loss of glycemic control when discontinuing such therapy1 114 |
Phenothiazines | Potential for decreased hypoglycemic effect1 114 | Observe carefully for loss of glycemic control when initiating concomitant therapy or hypoglycemic effects when discontinuing such therapy1 |
Phenytoin | Potential for decreased hypoglycemic effect1 114 | Observe carefully for loss of glycemic control when initiating concomitant therapy or hypoglycemic effects when discontinuing such therapy1 114 |
Probenecid | Highly protein-bound drugs may displace glimepiride from plasma proteins and potentiate hypoglycemic effect1 114 | Observe carefully for hypoglycemic effects when initiating concomitant therapy or loss of glycemic control when discontinuing such therapy1 114 |
Rifampin | Decreased AUC and half-life of glimepirideb No clinically important pharmacodynamic interactions reportedb | |
Salicylates (e.g., aspirin) | Highly protein-bound drugs may displace glimepiride from plasma proteins and potentiate hypoglycemic effect1 114 Increased glimepiride clearance with concomitant aspirin (1 g 3 times daily); no change in blood glucose concentrations or evidence of hypoglycemia1 114 | Observe carefully for hypoglycemic effects when initiating concomitant therapy or loss of glycemic control when discontinuing such therapy1 114 No evidence of clinically important adverse interactions in clinical studies1 |
Sulfonamides | Highly protein-bound drugs may displace glimepiride from plasma proteins and potentiate hypoglycemic effect1 114 No evidence of clinically important adverse interactions in clinical studies1 | Observe carefully for hypoglycemic effects when initiating concomitant therapy or loss of glycemic control when discontinuing such therapy1 114 |
Sympathomimetic agents | Potential for decreased hypoglycemic effect1 114 | Observe carefully for loss of glycemic control when initiating concomitant therapy or hypoglycemic effects when discontinuing such therapy1 |
Thyroid hormones | Potential for decreased hypoglycemic effect1 114 No evidence of clinically important adverse interactions in clinical studies1 | Observe carefully for loss of glycemic control when initiating concomitant therapy or hypoglycemic effects when discontinuing such therapy1 114 |
Completely absorbed; oral bioavailability of 100%.1 114 Peak blood concentrations attained within 2–3 hours.1 114
Fixed-combination preparation containing 4 mg of glimepiride and 4 mg of rosiglitazone is bioequivalent to the individual components administered separately at the same dosages in fasted state.c
Time to maximum effect about 2–3 hours.1
Glucose-lowering effect persists for 24 hours.1
Food increases the time to peak blood concentrations by about 12%.1 The mean peak blood concentration and AUC are decreased by 8 and 9%, respectively.1
Pediatric patients: Peak serum concentrations and AUC attained in children and adolescents 10–17 years of age were comparable to values in adults.c
Volume of distribution: 8.8 L (113 mL/kg).1
Not known if glimepiride is distributed into human milk.1
>99.5%.1 114
Metabolized by CYP2C9 and by cytosolic enzymes to active and inactive metabolites.1 114
Excreted in urine (60%) and feces (40%) predominantly as metabolites.1 114
Averages 5.3 hours after a single dose in healthy individuals.1 Averages 9.2 hours in patients with type 2 diabetes mellitus at steady state.1
Renal impairment: Decreased serum drug concentrations and increased concentrations and half-lives of the metabolites.1
Geriatric patients: At steady state, lower mean AUC (13%) and increased clearance (11%) compared with younger patients.114
Glimepiride: Well-closed containers at 15–30°C.1
Fixed combination of glimepiride and rosiglitazone: Tight, light-resistant containers at 25°C (may be exposed to 15–30°C).114 d
Reduces both fasting and postprandial blood glucose concentrations and HbA1c in a dose-dependent manner.1 5 6 20
Lowers blood glucose concentration principally by stimulating postprandial secretion of endogenous insulin from the beta cells of the pancreas.1 9 10 11 28 54 114 Also enhances peripheral sensitivity to insulin.1 2 3 5 6 49 50 114
Provides overall glycemic control without appreciably increasing fasting insulin secretion.1 2 3 5 6 49 50
Ineffective in the absence of functioning beta cells.1
Inform patients of the potential risks and advantages of glimepiride therapy and of alternative forms of treatment.1 114
Importance of taking the medication each morning with breakfast or with the first main meal.1 114
Importance of adhering to diet and exercise regimen.1 13 15 16 114 d
Importance of hygiene and avoidance of infection.31
Advise patients about the nature of diabetes mellitus, prevention and detection of complications, and importance of glycemic control.18 31 22
Importance of appropriate management of hypoglycemia and hyperglycemia.1 Risks of hypoglycemia.1 114 Importance of patients and responsible family members understanding symptoms and treatment of hypoglycemic reactions and identifying conditions that predispose to the development of such reactions.1 114
Importance of regular monitoring of blood glucose (preferably self-monitoring) and of HbA1c.1 114 d
Discuss potential for alterations in dosage requirements in special situations (e.g., illness, fever, trauma, infection, surgery); importance of informing clinician promptly if such situations occur.d
Importance of understanding primary and secondary failure to therapy.1
Importance of women informing clinicians if they are or plan to become pregnant or plan to breast-feed.1 d
Importance of informing clinicians of existing or contemplated concomitant therapy, including prescription and OTC drugs and dietary or herbal supplements,1 as well as any concomitant illnesses (e.g., type 1 diabetes mellitus, kidney or liver disease).d
Advise patients receiving β-adrenergic blocking agents about potential risk for hypoglycemia.114
Importance of informing patients of other important precautionary information.1 (See Cautions.)
Excipients in commercially available drug preparations may have clinically important effects in some individuals; consult specific product labeling for details.
* available from one or more manufacturer, distributor, and/or repackager by generic (nonproprietary) name
Routes | Dosage Forms | Strengths | Brand Names | Manufacturer |
|---|---|---|---|---|
Oral | Tablets | 1 mg* | Amaryl (with povidone; scored) | Sanofi-Aventis |
2 mg* | Amaryl (with povidone; scored) | Sanofi-Aventis | ||
4 mg* | Amaryl (with povidone; scored) | Sanofi-Aventis |
Routes | Dosage Forms | Strengths | Brand Names | Manufacturer |
|---|---|---|---|---|
Oral | Tablets | 2 mg with Rosiglitazone Maleate 4 mg (of rosiglitazone) | Avandaryl | GlaxoSmithKline |
2 mg with Rosiglitazone Maleate 8 mg (of rosiglitazone) | Avandaryl | GlaxoSmithKline | ||
4 mg with Rosiglitazone Maleate 4 mg (of rosiglitazone) | Avandaryl | GlaxoSmithKline | ||
4 mg with Rosiglitazone Maleate 8 mg (of rosiglitazone) | Avandaryl | GlaxoSmithKline |
This pricing information is subject to change at the sole discretion of DS Pharmacy. This pricing information was updated 03/2011. Actual costs to patients will vary depending on the use of specific retail or mail-order locations and health insurance copays.
Amaryl 1MG Tablets (SANOFI-AVENTIS U.S.): 30/$33.2 or 90/$71.49
Amaryl 2MG Tablets (SANOFI-AVENTIS U.S.): 30/$43.42 or 90/$102.15
Amaryl 4MG Tablets (SANOFI-AVENTIS U.S.): 30/$67.09 or 90/$176.55
Avandaryl 4-1MG Tablets (GLAXO SMITH KLINE): 30/$155.31 or 90/$434.86
Avandaryl 4-2MG Tablets (GLAXO SMITH KLINE): 30/$156.67 or 90/$447.65
Avandaryl 4-4MG Tablets (GLAXO SMITH KLINE): 30/$155.31 or 90/$434.86
Duetact 30-2MG Tablets (TAKEDA PHARMACEUTICALS): 30/$263.99 or 90/$766.95
Duetact 30-4MG Tablets (TAKEDA PHARMACEUTICALS): 30/$245.98 or 90/$685.99
Glimepiride 1MG Tablets (PERRIGO PHARMACEUTICALS): 30/$12.99 or 60/$19.98
Glimepiride 2MG Tablets (DR.REDDY'S LABORATORIES INC.): 90/$18.99 or 180/$37.98
Glimepiride 4MG Tablets (PERRIGO PHARMACEUTICALS): 30/$14.99 or 90/$41.99
This report on medications is for your information only, and is not considered individual patient advice. Because of the changing nature of drug information, please consult your physician or pharmacist about specific clinical use.
The American Society of Health-System Pharmacists, Inc. and Drugs.com represent that the information provided hereunder was formulated with a reasonable standard of care, and in conformity with professional standards in the field. The American Society of Health-System Pharmacists, Inc. and Drugs.com make no representations or warranties, express or implied, including, but not limited to, any implied warr
Beechams Breathe Clear Hot Honey & Lemon Menthol Flavour powder for oral solution
|
|
|
|
|
|
|
|
|
|
|
|
For a full list of excipients, see section 6.1.
Powder for Oral Solution.
Off-white to beige, free-flowing, heterogeneous powder with an odour of honey, lemon and menthol.
The relief of symptoms of influenza, feverishness, chills and feverish colds including headache, sore throat pain, aches and pains, nasal congestion, sinusitis and its associated pain, and acute nasal catarrh.
Directions for use
Empty contents of sachet into beaker. Half fill with very hot water. Stir well. Add cold water as necessary and sugar if desired.
Recommended Dose and Dosage Schedule
Adults (including elderly) and children aged 12 years and over:
One sachet to be taken every four hours, if necessary, up to a maximum of six sachets in any 24 hours.
Do not take continuously for more than 7 days without medical advice.
Not to be given to children under 12 years of age except on medical advice.
Hypersensitivity to the active substances or to any of the excipients.
Concomitant use of other sympathomimetic decongestants.
Phaeochromocytoma.
Closed angle glaucoma.
Hypertensive patients or those taking of have taken in the last two weeks monoamine oxidase inhibitors, tricyclic antidepressants or beta-blockers (see section 4.5). Hepatic or renal impairment, diabetes, hyperthyroidism and cardiovascular disease.
Care is advised in the administration of paracetamol to patients with severe renal or severe hepatic impairment. The hazard of overdose is greater in those with non-cirrhotic alcoholic liver disease.
Medical advice should be sought before taking this product in patients with these conditions:
• An enlargement of the prostate gland
• Occlusive Vascular disease (e.g. Raynaud's Phenomenon)
This product should not be used by patients taking other sympathomimetics (such as decongestants, appetite suppressants and amphetamine-like psychostimulants).
Patients with rare hereditary problems of fructose intolerance, glucose-galactose malabsorption or sucrase-isomaltase insufficiency should not take this medicine.
Do not exceed the stated dose.
Patients should be advised not to take other paracetamol-containing or any other cold, flu or decongestant products concurrently.
If symptoms persist consult your doctor.
Keep out of the reach and sight of children.
Special label warnings
Do not take with other flu, cold or decongestant products. Do not take with any other paracetamol-containing products.
Immediate medical advice should be sought in the event of an overdose, even if you feel well.
Special leaflet warnings
Immediate medical advice should be sought in the event of an overdose, even if you feel well, because of the risk of delayed, serious liver damage.
The speed of absorption of paracetamol may be increased by metoclopramide or domperidone and absorption reduced by colestyramine. The anticoagulant effect of warfarin and other coumarins may be enhanced by prolonged regular daily use of paracetamol with increased risk of bleeding, occasional doses have no significant effect.
Phenylephrine should be used with caution in combination with the following drugs as interactions have been reported.
|
|
|
|
|
|
|
|
|
|
|
|
Due to the phenylephrine content this product should not be used in pregnancy or whilst breast-feeding without medical advice. Phenylephrine may be excreted in breast milk.
Patients should be advised not to drive or operate machinery if affected by dizziness.
Paracetamol
Adverse events from historical clinical trial data are both infrequent and from small patient exposure. Accordingly, events reported from extensive post-marketing experience at therapeutic/labelled dose and considered attributable are tabulated below by system class. Due to limited clinical trial data, the frequency of these adverse events is not known (cannot be estimated from available data), but post-marketing experience indicates that adverse reactions to paracetamol are rare and serious reactions are very rare.
|
|
|
|
|
|
|
|
|
|
* There have been cases of bronchospasm with paracetamol, but these are more likely in asthmatics sensitive to aspirin or other NSAIDs.
Phenylephrine
The following adverse events have been observed in clinical trials with phenylephrine and may therefore represent the most commonly occurring adverse events.
|
|
|
|
|
|
|
|
|
|
Adverse reactions identified during post-marketing use are listed below. The frequency of these reactions is unknown but likely to be rare.
|
|
|
|
|
|
|
|
Paracetamol
Liver damage is possible in adults who have taken 10g or more of paracetamol. Ingestion of 5g or more of paracetamol may lead to liver damage if the patient has risk factors (see below).
Risk factors:
If the patient
a. Is on long term treatment with carbamazepine, phenobarbitone, phenytoin, primidone, rifampicin, St John's Wort or other drugs that induce liver enzymes.
OR
b. Regularly consumes ethanol in excess of recommended amounts.
OR
c. Is likely to be glutathione deplete e.g. eating disorders, cystic fibrosis, HIV infection, starvation, cachexia.
Symptoms:
Symptoms of paracetamol overdosage in the first 24 hours are pallor, nausea, vomiting, anorexia and abdominal pain. Liver damage may become apparent 12 to 48 hours after ingestion. Abnormalities of glucose metabolism and metabolic acidosis may occur. In severe poisoning, hepatic failure may progress to encephalopathy, haemorrhage, hypoglycaemia, cerebral oedema, and death. Acute renal failure with acute tubular necrosis, strongly suggested by loin pain, haematuria and proteinuria, may develop even in the absence of severe liver damage. Cardiac arrhythmias and pancreatitis have been reported.
Management:
Immediate treatment is essential in the management of paracetamol overdose. Despite a lack of significant early symptoms, patients should be referred to hospital urgently for immediate medical attention. Symptoms may be limited to nausea or vomiting and may not reflect the severity of overdose or the risk of organ damage. Management should be in accordance with established treatment guidelines, see BNF overdose section.
Treatment with activated charcoal should be considered if the overdose has been taken within 1 hour. Plasma paracetamol concentration should be measured at 4 hours or later after ingestion (earlier concentrations are unreliable). Treatment with N-acetylcysteine may be used up to 24 hours after ingestion of paracetamol, however, the maximum protective effect is obtained up to 8 hours post-ingestion. The effectiveness of the antidote declines sharply after this time. If required the patient should be given intravenous N-acetylcysteine, in line with the established dosage schedule. If vomiting is not a problem, oral methionine may be a suitable alternative for remote areas, outside hospital. Management of patients who present with serious hepatic dysfunction beyond 24 hours from ingestion should be discussed with the NPIS or a liver unit.
Phenylephrine Hydrochloride
Symptoms and signs:
Phenylephrine overdosage is likely to result in effects similar to those listed under adverse reactions. Additional symptoms may include hypertension and possibly reflux bradycardia. In severe cases confusion, hallucinations, seizures and arrythmias may occur. However the amount required to produce serious phenylephrine toxicity would be greater than required to cause paracetamol-related toxicity.
Treatment
Treatment should be as clinically appropriate. Severe hypertension may need to be treated with an alpha blocking drug such as phentolamine.
Ascorbic Acid
Symptoms and signs
High doses of ascorbic acid (>3000 mg) may cause transient osmotic diarrhoea and gastrointestinal effects such as nausea and abdominal discomfort. Effects of overdose of ascorbic acid would be subsumed by severe liver toxicity caused by paracetamol overdose.
Paracetamol provides the analgesic and antipyretic actions.
Phenylephrine Hydrochloride is a sympathomimetic agent and provides relief from nasal congestion due to its vasoconstrictor action.
Ascorbic Acid is commonly included in combination cold products to compensate for vitamin C losses that may occur in the initial stages of acute viral infections, including the common cold.
Paracetamol - Is readily absorbed from the gastrointestinal tract. It is metabolised in the liver and excreted in the urine, mainly as glucuronide and sulphate conjugates.
Ascorbic Acid - Is readily absorbed from the GI tract and is widely distributed in the body tissues, 25% bound to plasma proteins. Ascorbic acid in excess of the body's needs is eliminated in the urine as metabolites.
Phenylephrine Hydrochloride - Due to irregular absorption and first pass metabolism by monoamine oxidase in the gut and liver, phenylephrine has reduced bioavailability from the gastrointestinal tract. It is excreted in the urine almost entirely as the sulphate conjugate.
None stated.
Ascorbic acid, Sucrose, Sodium citrate, Citric acid, Maize starch, Menthol, Honey flavour, Honey Flav-o-lok, Lemon flavour, Caramel SCS (E 150), aspartame, saccharin sodium.
None stated.
36 months.
Store below 25°C.
The product is packed in laminate sachets comprising paper / polythene / aluminium foil / polythene. Five or ten sachets may be contained in a box board carton.
No special requirements.
Any unused product or waste material should be disposed of in accordance with local requirements.
Beecham Group plc
980 Great West Road
Brentford
Middlesex
TW8 9GS
United Kingdom
Trading as GlaxoSmithKline Consumer Healthcare
Brentford
TW8 9GS
U.K.
PL 00079/0674
29/07/2011
29/07/2011
