Glimepiride (Glimepiride)

Trade Name : Glimepiride

Teva Pharmaceuticals USA, Inc.

TABLET

Strength 1 mg/1

GLIMEPIRIDE Sulfonylurea [EPC],Sulfonylurea Compounds [CS]

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Trade Marks displayed in compliance with provisions of: Trademark Act, 1999 u/s 30 and 30 (1) of "Fair use"

GNH India is WHO GDP and ISO 9001 2015 Certified Pharmaceutical Wholesaler/ Supplier/ Exporters/ Importer from India of Glimepiride (Glimepiride) which is also known as Glimepiride and Manufactured by Teva Pharmaceuticals USA, Inc.. It is available in strength of 1 mg/1 per ml. Read more

Glimepiride (Glimepiride) is supplied for Tenders/ Emergency imports/ Un - licensed, Specials, Orphan drug/ Name patient line/ RLD supplies/ Reference listed drugs/ Comparator Drug/ Bio-Similar/ Innovator samples For Clinical trials. Click to know price. Read less

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No data

Glimepiride tablets are indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus n
Limitations of Use
Glimepiride tablets should not be used for the treatment of type 1 diabetes mellitus or diabetic ketoacidosis, as it would not be effective in these settings.
Glimepiride tablets are a sulfonylurea indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. ()
Limitations of Use:

Not for treating type 1 diabetes mellitus or diabetic ketoacidosis. ()

Glimepiride tablets should be administered with breakfast or the first main meal of the day.
The recommended starting dose of glimepiride tablets is 1 mg or 2 mg once daily. Patients at increased risk for hypoglycemia (e.g., the elderly or patients with renal impairment) should be started on 1 mg once dailyn
After reaching a daily dose of 2 mg, further dose increases can be made in increments of 1 mg or 2 mg based upon the patientu2019s glycemic response. Uptitration should not occur more frequently than every 1 to 2 weeks. A conservative titration scheme is recommended for patients at increased risk for hypoglycemia n
The maximum recommended dose is 8 mg once daily.
Patients being transferred to glimepiride tablets from longer half-life sulfonylureas (e.g., chlorpropamide) may have overlapping drug effect for 1 to 2 weeks and should be appropriately monitored for hypoglycemia.
When colesevelam is coadministered with glimepiride, maximum plasma concentration and total exposure to glimepiride is reduced. Therefore, glimepiride tablets should be administered at least 4 hours prior to colesevelam.

Recommended starting dose is 1 or 2 mg once daily. Increase in 1 or 2 mg increments no more frequently than every 1 to 2 weeks based on glycemic response. Maximum recommended dose is 8 mg once daily. ()
Administer with breakfast or first meal of the day. ()
Use 1 mg starting dose and titrate slowly in patients at increased risk for hypoglycemia (e.g., elderly, patients with renal impairment). ()

Tablets (scored): 1 mg, 2 mg, 4 mg ()

Glimepiride tablets are contraindicated in patients with a history of a hypersensitivity reaction to:

Hypersensitivity to glimepiride or any of the productu2019s ingredients. ()
Hypersensitivity to sulfonamide derivatives. ()

No data

Hypoglycemia: May be severe. Ensure proper patient selection, dosing, and instructions, particularly in at-risk populations (e.g., elderly, renally impaired) and when used with other anti-diabetic medications. ()
Hypersensitivity Reactions: Postmarketing reports include anaphylaxis, angioedema and Stevens-Johnson Syndrome. If a reaction is suspected, promptly discontinue glimepiride, assess for other potential causes for the reaction, and institute alternative treatment for diabetes. ()
Hemolytic Anemia: Can occur if glucose 6-phosphate dehydrogenase (G6PD) deficient. Consider a non-sulfonylurea alternative. ()
Potential Increased Risk of Cardiovascular Mortality with Sulfonylureas: Inform patient of risks, benefits and treatment alternatives. ()
Macrovascular Outcomes: No clinical studies establishing conclusive evidence of macrovascular risk reduction with glimepiride or any other anti-diabetic drug. ()

The following serious adverse reactions are discussed in more detail below and elsewhere in the labeling:
u00a0Common adverse reactions in clinical trials (u2265 5% and more common than with placebo) include hypoglycemia, headache, nausea, and dizziness. ()
To report SUSPECTED ADVERSE REACTIONS, contact TEVA USA, PHARMACOVIGILANCE at 1-866-832-8537 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

No data

Certain medications may affect glucose metabolism, requiring glimepiride dose adjustment and close monitoring of blood glucose. ()
Miconazole: Severe hypoglycemia can occur when glimepiride and oral miconazole are used concomitantly. ()
Cytochrome P450 2C9 interactions: Inhibitors and inducers of cytochrome P450 2C9 may affect glycemic control by altering glimepiride plasma concentrations. ()
Colesevelam: Coadministration may reduce glimepiride absorption. Glimepiride should be administered at least 4 hours prior to colesevelam. (, )

No data

An overdosage of glimepiride, as with other sulfonylureas, can produce severe hypoglycemia. Mild episodes of hypoglycemia can be treated with oral glucose. Severe hypoglycemic reactions constitute medical emergencies requiring immediate treatment. Severe hypoglycemia with coma, seizure, or neurological impairment can be treated with glucagon or intravenous glucose. Continued observation and additional carbohydrate intake may be necessary because hypoglycemia may recur after apparent clinical recovery n

Glimepiride Tablets USP are an oral sulfonylurea that contain the active ingredient glimepiride, USP. Glimepiride, USP is a white to yellowish-white, crystalline, odorless to practically odorless powder formulated into tablets of 1 mg, 2 mg, and 4 mg strengths for oral administration. Glimepiride Tablets USP contain the active ingredient glimepiride, USP and the following inactive ingredients: lactose monohydrate, magnesium stearate, microcrystalline cellulose, povidone, and sodium starch glycolate. In addition, Glimepiride Tablets USP, 1 mg contain ferric oxide red, Glimepiride Tablets USP, 2 mg contain ferric oxide yellow and FD&C Blue #2 aluminum lake, and Glimepiride Tablets USP, 4 mg contain FD&C Blue #2 aluminum lake.
Chemically, glimepiride, USP is identified as 1-[[p-[2-(3-ethyl-4-methyl-2-oxo-3-pyrroline-1-carboxamido)ethyl]phenyl]sulfonyl]-3-(trans-4-methylcyclohexyl)urea.
The structural formula is:
CHNOS M.W. 490.62
Glimepiride, USP is practically insoluble in water.

No data

Studies in rats at doses of up to 5000 parts per million (ppm) in complete feed (approximately 340 times the maximum recommended human dose, based on surface area) for 30 months showed no evidence of carcinogenesis. In mice, administration of glimepiride for 24 months resulted in an increase in benign pancreatic adenoma formation that was dose-related and was thought to be the result of chronic pancreatic stimulation. No adenoma formation in mice was observed at a dose of 320 ppm in complete feed, or 46 to 54 mg/kg body weight/day. This is at least 28 times the maximum human recommended dose of 8 mg once daily based on surface area.
Glimepiride was non-mutagenic in a battery of and mutagenicity studies (Ames test, somatic cell mutation, chromosomal aberration, unscheduled DNA synthesis, and mouse micronucleus test).
There was no effect of glimepiride on male mouse fertility in animals exposed up to 2500 mg/kg body weight (> 1,500 times the maximum recommended human dose based on surface area). Glimepiride had no effect on the fertility of male and female rats administered up to 4000 mg/kg body weight (approximately 4,000 times the maximum recommended human dose based on surface area).

A total of 304 patients with type 2 diabetes already treated with sulfonylurea therapy participated in a 14-week, multicenter, randomized, double-blind, placebo-controlled trial evaluating the safety and efficacy of glimepiride monotherapy. Patients discontinued their sulfonylurea therapy then entered a 3-week placebo washout period followed by randomization into 1 of 4 treatment groups: placebo (n = 74), glimepiride 1 mg (n = 78), glimepiride 4 mg (n = 76), and glimepiride 8 mg (n = 76). All patients randomized to glimepiride started 1 mg daily. Patients randomized to glimepiride 4 mg or 8 mg had blinded, forced titration of the glimepiride dose at weekly intervals, first to 4 mg and then to 8 mg, as long as the dose was tolerated, until the randomized dose was reached. Patients randomized to the 4 mg dose reached the assigned dose at Week 2. Patients randomized to the 8 mg dose reached the assigned dose at Week 3. Once the randomized dose level was reached, patients were to be maintained at that dose until Week 14. Approximately 66% of the placebo-treated patients completed the trial compared to 81% of patients treated with glimepiride 1 mg and 92% of patients treated with glimepiride 4 mg or 8 mg. Compared to placebo, treatment with glimepiride 1 mg, 4 mg, and 8 mg daily provided statistically significant improvements in HbA compared to placebo (Table 3).
A total of 249 patients who were treatment-nau00efve or who had received limited treatment with antidiabetic therapy in the past were randomized to receive 22 weeks of treatment with either glimepiride (n = 123) or placebo (n = 126) in a multicenter, randomized, double-blind, placebo-controlled, dose-titration trial. The starting dose of glimepiride was 1 mg daily and was titrated upward or downward at 2-week intervals to a goal FPG of 90 to 150 mg/dL. Blood glucose levels for both FPG and PPG were analyzed in the laboratory. Following 10 weeks of dose adjustment, patients were maintained at their optimal dose (1, 2, 3, 4, 6, or 8 mg) for the remaining 12 weeks of the trial. Treatment with glimepiride provided statistically significant improvements in HbA and FPG compared to placebo (Table 4).

Glimepiride Tablets USP are available as:
1 mg - mottled pink, round tablet, bisected on both sides. One side of the tablet is debossed with u201c9u201d on one side of score and u201c3u201d on the other. The other side of the tablet is debossed with u201c72u201d on one side of score and u201c54u201d on the other. Available in bottles of 100 (NDC 0093-7254-01).
2 mg - mottled green, round tablet, bisected on both sides. One side of the tablet is debossed with u201c9u201d on one side of score and u201c3u201d on the other. The other side of the tablet is debossed with u201c72u201d on one side of score and u201c55u201d on the other. Available in bottles of 100 (NDC 0093-7255-01).
4 mg - mottled light blue, round tablet, bisected on both sides. One side of the tablet is debossed with u201c9u201d on one side of score and u201c3u201d on the other. The other side of the tablet is debossed with u201c72u201d on one side of score and u201c56u201d on the other. Available in bottles of 100 (NDC 0093-7256-01) and 250 (NDC 0093-7256-52).
Store at 20u00b0 to 25u00b0C (68u00b0 to 77u00b0F) [See USP Controlled Room Temperature].
Dispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure (as required).

Hypoglycemia
Explain the symptoms and treatment of hypoglycemia as well as conditions that predispose to hypoglycemia. Inform patients that their ability to concentrate and react may be impaired as a result of hypoglycemia and that this may present a risk in situations where these abilities are especially important, such as driving or operating other machinery n
Hypersensitivity Reactions
Inform patients that hypersensitivity reactions may occur with glimepiride and that if a reaction occurs to seek medical treatment and discontinue glimepiride n n
Pregnancy
Advise females of reproductive potential to inform their prescriber of a known or suspected pregnancy n
Lactation
Advise breastfeeding women taking glimepiride to monitor breastfed infants for signs of hypoglycemia (e.g., jitters, cyanosis, apnea, hypothermia, excessive sleepiness, poor feeding, seizures) n
Manufactured In Israel By:
Teva Pharmaceutical Ind. Ltd.
Jerusalem, 9777402, Israel
Manufactured For:
Teva Pharmaceuticals USA, Inc.
North Wales, PA 19454
Rev. O 2/2019

NDCn- -7254-
Glimepirideu00a0n- Tablets USPu00a0n- 1 mg
ONCE A DAY
Rx only
100 TABLETS
TEVA

NDCn- -7255-
Glimepirideu00a0n- Tablets USPu00a0n- 2 mg
ONCE A DAY
Rx only
100 TABLETS
TEVA

NDCn- -7256-
Glimepirideu00a0n- Tablets USPu00a0n- 4 mg
ONCE A DAY
Rx only
100 TABLETS
TEVA

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Glimepiride (Glimepiride)

Trade Name : Glimepiride

TABLET

Delivery Process

Product information is meant for

Disclaimer

Trade Marks displayed in compliance with provisions of: Trademark Act, 1999 u/s 30 and 30 (1) of "Fair use"

Packaging and Delivery

About GNH

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Glimepiride (Glimepiride)

Trade Name : Glimepiride

TABLET

Delivery Process

Product information is meant for

Disclaimer

Trade Marks displayed in compliance with provisions of: Trademark Act, 1999 u/s 30 and 30 (1) of "Fair use"

Packaging and Delivery

About GNH

Similar Products

Desogestrel And Ethinyl Estradiol (Emoquette)

Diphenoxylate Hydrochloride And Atropine Sulfate (Diphenoxylate Hydrochloride And Atropine Sulfate)

Fluoxetine Hydrochloride (Fluoxetine)

Metoprolol Succinate (Metoprolol Succinate)

Losartan Potassium (Losartan Potassium)

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Swiss Drugs

NZ Drugs

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