Glimepiride (Glimepiride)

Trade Name : Glimepiride

Mylan Pharmaceuticals Inc.

TABLET

Strength 1 mg/1

GLIMEPIRIDE Sulfonylurea [EPC],Sulfonylurea Compounds [CS]

Delivery Process

Submit a Request

You can fill in a request for your medicine through the form provided. You can access the form by clicking on the ‘Get Price’ button.

We’ll Get in Touch

Once we review your request, we’ll send you an estimated price for the medicine within 2-5 days.

Confirmation and Payment

You can fill in a request for your medicine through the form provided. You can access the form by clicking on the ‘Get Price’ button.

Submit a Request

You can fill in a request for your medicine through the form provided. You can access the form by clicking on the ‘Get Price’ button.

Product information is meant for

Wholesalers Suppliers Exporters Doctors MOH Tender Supplies Hospitals Brand CROs Comparator Supplies Generic Cooperate Sourcing Individual Patients Indian Institutional Buyers

Disclaimer

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 Mylan Pharmaceuticals 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

Packaging and Delivery

Validated Cold Chain Shipment

We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

Inquire directly from our website and get 5% off on any medicine!

We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

Read more

About GNH

We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

Read more
  • 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:
  • u2022
  • 1
  • 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 daily n
  • 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.
  • Glimepiride Tablets, USP are available containing 1 mg, 2 mg or 4 mg of glimepiride, USP.
  • Tablets (scored): 1 mg, 2 mg, 4 mg ()
  • Glimepiride tablets are contraindicated in patients with a history of a hypersensitivity reaction to:
  • No data
  • The following serious adverse reactions are discussed in more detail below and elsewhere in the labeling:
  • Common 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 Mylan at 1-877-446-3679 (1-877-4-INFO-RX) or FDA at 1-800-FDA-1088 or
  • No data
  • 2.1n- 7.4
  • No data
  • 8.5n- 8.6
  • An overdosage of glimepiride tablets, 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 recoveryn
  • Glimepiride tablets, USP are an oral sulfonylurea that contains the active ingredient glimepiride. Chemically, glimepiride is identified as 1-[[-[2-(3-Ethyl-4-methyl-2-oxo-3-pyrroline-1-carboxamido)ethyl]phenyl]sulfonyl]-3-(-4-methylcyclohexyl)urea (CHNOS) with a molecular weight of 490.62. Glimepiride, USP is a white, crystalline, odorless to practically odorless powder and is practically insoluble in water.
  • The structural formula is:
  • u00a0
  • Glimepiride tablets contain the active ingredient glimepiride and the following inactive ingredients:lactose monohydrate, magnesium stearate, microcrystallinecellulose, povidone, sodium lauryl sulfate and sodium starch glycolate (potato). In addition, the 2u00a0mg and 4 mg tablets contain D&C Yellow No. 10 Aluminum Lake and the 4 mg tablets also contain D&C Red No. 27 Aluminum Lake.
  • 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 46-54 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 tablets 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 tablets 1 mg (n = 78), glimepiride tablets 4 mg (n = 76), and glimepiride tablets 8 mg (n = 76). All patients randomized to glimepiride tablets started 1 mg daily. Patients randomized to glimepiride tablets 4 mg or 8 mg had blinded, forced titration of the glimepiride tablets 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 tablets 1 mg, 4 mg, and 8 mg daily provided statistically significant improvements in HbA1C compared to placebo (Table 3).
  • A total of 249 patients who were treatment-naive or who had received limited treatment with antidiabetic therapy in the past were randomized to receive 22 weeks of treatment with either glimepiride tablets (n = 123) or placebo (n = 126) in a multicenter, randomized, double-blind, placebo-controlled, dose-titration trial. The starting dose of glimepiride tablets was 1 mg daily and was titrated upward or downward at 2-week intervals to a goal FPG of 90-150 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 tabletsprovided statistically significant improvements in HbA1C and FPG compared to placebo (Table 4).
  • Glimepiride Tablets, USP are available containing 1 mg, 2 mg or 4 mg of glimepiride, USP.
  • The 1 mg tablets are white to off-white, oval, scored tablets debossed with to the left of the score and to the right of the score on one side of the tablet and on the other side. They are available as follows:
  • NDC 0378-4011-01bottles of 100 tablets
  • The 2 mg tablets are light yellow, oval, scored tablets debossed with to the left of the score andto the right of the score on one side of the tablet and on the other side. They are available as follows:
  • NDC 0378-4012-01bottles of 100 tablets
  • The 4 mg tablets are peach, oval, scored tablets debossed with to the left of the score andto the right of the score on one side of the tablet and on the other side. They are available as follows:
  • NDC 0378-4013-01bottles of 100 tablets
  • 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 using a child-resistant closure.
  • Hypoglycemia:n- [see ]
  • Hypersensitivity Reactions: n- [see ].
  • Pregnancy:n- [see ].
  • Lactation: n- [see ].
  • Mylan Pharmaceuticals Inc.n
  • Revised: 1/2019GLIM:R8
  • NDC 0378-4011-01
  • Glimepiriden- Tablets, USPn- 1 mg
  • Once A Day
  • Rx only u00a0u00a0u00a0u00a0u00a0100 Tablets
  • Each tablet contains:Glimepiride, USP 1 mg
  • Dispense in a tight, light-resistantcontainer as defined in the USPusing a child-resistant closure.
  • Keep container tightly closed.
  • Keep this and all medicationn- out of the reach of children.
  • Store at 20u00b0 to 25u00b0C (68u00b0 to 77u00b0F).n- [See USP Controlled Roomn- Temperature.]
  • Usual Dosage:
  • Mylan Pharmaceuticals Inc.
  • Mylan.com
  • RM4011A3
  • NDC 0378-4012-01
  • Glimepiriden- Tablets, USPn- 2 mg
  • Once A Day
  • Rx only u00a0u00a0u00a0u00a0u00a0100 Tablets
  • Each tablet contains:Glimepiride, USP 2 mg
  • Dispense in a tight, light-resistantcontainer as defined in the USPusing a child-resistant closure.
  • Keep container tightly closed.
  • Keep this and all medicationn- out of the reach of children.
  • Store at 20u00b0 to 25u00b0C (68u00b0 to 77u00b0F).n- [See USP Controlled Roomn- Temperature.]
  • Usual Dosage:
  • Mylan Pharmaceuticals Inc.
  • Mylan.com
  • RM4012A3
  • NDC 0378-4013-01
  • Glimepiriden- Tablets, USPn- 4 mg
  • Once A Day
  • Rx only u00a0u00a0u00a0u00a0u00a0100 Tablets
  • Each tablet contains:Glimepiride, USP 4 mg
  • Dispense in a tight, light-resistantcontainer as defined in the USPusing a child-resistant closure.
  • Keep container tightly closed.
  • Keep this and all medicationn- out of the reach of children.
  • Store at 20u00b0 to 25u00b0C (68u00b0 to 77u00b0F).n- [See USP Controlled Roomn- Temperature.]
  • Usual Dosage:
  • Mylan Pharmaceuticals Inc.
  • Mylan.com
  • RM4013A3

Browse Our Services And Processes

Comparator Sourcing for Clinical Trials

Comparator Sourcing for Clinical Trials

GNH India brings over 10 years of experience in Comparator

Read More

Name Patient Supply

Name Patient Supply

Today, the exact cause for many rare diseases remains unknown

Read More

Validated Cold Chain Shipment

Validated Cold Chain Shipment

With shifting of pharma industry from synthetic molecules to biologic

Read More

Clinical Trials Supply

Clinical Trials Supply

STOP SOURCING..... START SMART SOURCING...... COME STRAIGHT TO THE SOURCE

Read More

Dossiers and Stability Studies

Dossiers and Stability Studies

STABILITY STUDIES STABILITY, BA / BE STUDIES Due to our active

Read More

Pharmaceutical Contract Manufacturing

Pharmaceutical Contract Manufacturing

GNH Provides Contract Manufacturing services for: Generic Medicines with following

Read More

Pricing

Pricing

PRICING POLICY Terms of sales are typically prepaid, unless otherwise

Read More

Disclaimer

Please see the Legal Notice for detailed terms and disclaimers. The Legal Notice governs the use of this Website and by accessing and using this Website you agree to be bound by and accept the Legal Notice.

Browse from other international pharmaceuticals

General

64020 Products

GNH India Brings to over 64036 Product SKUs from India all at 1 place with easy access and global deliveries.

US NDC

71247 Products

GNH India Brings to over 71252 Product SKUs from India all at 1 place with easy access and global deliveries.

Canadian DIN

51046 Products

GNH India Brings to over 51047 Product SKUs from India all at 1 place with easy access and global deliveries.

Swiss Drugs

150 Products

GNH India Brings to over 150 Product SKUs from India all at 1 place with easy access and global deliveries.

NZ Drugs

13296 Products

GNH Brings to over 13298 Product SKUs from India all at 1 place with easy access and global deliveries.

FAQ

Check out our delivery process

Can’t find what
you’re looking for?

Contact US
Pharmexcil
DB
FIEO-2016
SiteLock

Copyright © 2024 GNHIndia .com. All Rights Reserved. Please read Legal Notice for further details.

Disclaimer: Product names, logos, brands and other trademarks featured or referred to are the property of their respective trademark holders.