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Repaglinide (Repaglinide)

Trade Name : Repaglinide

Paddock Laboratories, LLC

TABLET

Strength 0.5 mg/1

REPAGLINIDE Glinide [EPC],Potassium Channel Antagonists [MoA]

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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 Repaglinide (Repaglinide) which is also known as Repaglinide and Manufactured by Paddock Laboratories, LLC. It is available in strength of 0.5 mg/1 per ml. Read more

Repaglinide (Repaglinide) 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.

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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.

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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.

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  • No data
  • Repaglinide tablets are indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.
  • Limitation of Use:
  • Repaglinide tablets should not be used in patients with type 1 diabetes mellitus or for the treatment of diabetic ketoacidosis.
  • Repaglinide tablets are a glinide indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.
  • Limitation of Use:
  • Not for treatment of type 1 diabetes mellitus or diabetic ketoacidosis
  • No data
  • 1cn- 1c
  • Tablets: 0.5 mg, 1 mg, 2 mg
  • Repaglinide tablets are contraindicated in patients with:
  • No data
  • Hypoglycemia
  • Serious Cardiovascular Adverse Reactions with Concomitant NPH-insulin
  • Macrovascular outcomes
  • The following serious adverse reaction is also described elsewhere in the labeling:
  • Hypoglycemia n
  • The most common adverse reactions (5% or greater incidence) among patients treated with repaglinide tablets were: hypoglycemia, upper respiratory infection, headache, sinusitis, arthralgia, nausea, diarrhea, and back pain. (6.1)
  • Clinically Important Drug Interactions with Repaglinide Tablets
  • Table 3 includes a list of drugs with clinically important drug interactions when administered concomitantly with repaglinide tablets and instructions for preventing or managing them.
  • Table 3: Clinically Important Drug Interactions with Repaglinide Tablets
  • Clopidogrel
  • Cyclosporine
  • CYP2C8 and CYP3A4 Inhibitors and Drugs That May Increase the Risk of Hypoglycemia
  • CYP2C8 and CYP3A4 Inducers and Drugs That May Decrease the Blood Glucose Lowering Effect of Repaglinide tablets
  • Drugs That May Blunt Signs and Symptoms of Hypoglycemia
  • No data
  • u2022
  • Lactation
  • Severe hypoglycemic reactions with coma, seizure, or other neurological impairment may occur and constitute medical emergencies requiring immediate hospitalization. Hypoglycemic symptoms without loss of consciousness or neurologic findings should be treated aggressively with oral glucose and adjustments in drug dosage and/or meal patterns. Close monitoring may continue until the physician is assured that the patient is out of danger. Patients should be closely monitored for a minimum of 24 to 48 hours, since hypoglycemia may recur after apparent clinical recovery. There is no evidence that repaglinide tablets are dialyzable using hemodialysis.
  • Repaglinide Tablets, USP are an oral blood glucose-lowering drug of the glinide class. Repaglinide, S(+)2-ethoxy-4(2((3-methyl-1-(2-(1-piperidinyl) phenyl)-butyl) amino)-2-oxoethyl) benzoic acid, is chemically unrelated to the oral sulfonylurea insulin secretagogues.
  • Structural Formula of Repaglinide
  • Repaglinide is a white to off-white powder with molecular formula CHNO and a molecular weight of 452.6. Repaglinide Tablets, USP contain 0.5 mg, 1 mg or 2 mg of repaglinide. In addition, each tablet contains the following inactive ingredients: anhydrous dibasic calcium phosphate, microcrystalline cellulose, corn starch, polacrilin potassium, povidone, glycerin, magnesium stearate, meglumine and poloxamer, and colloidal silicon dioxide. The 1 mg and 2 mg tablets contain ferric oxides (yellow and red, respectively) as coloring agents.
  • No data
  • In a 104-week carcinogenicity study in rats at doses up to 120 mg/kg/day, which is approximately 90 times clinical exposure on a mg/m basis, the incidences of benign adenomas of the thyroid and liver were increased in male rats. No evidence of carcinogenicity was found in female rats. The higher incidences of thyroid and liver tumors in male rats were not seen at lower dose of 30 mg/kg/day and 60 mg/kg/day respectively (which are over 20 and 45 times, respectively, clinical exposures on a mg/m basis). In a 104-week carcinogenicity study in mice at doses up to 500 mg/kg/day, no evidence of carcinogenicity was found in mice (which is approximately 187 times clinical exposure on a mg/m basis).
  • Repaglinide was non-genotoxic in a battery of and studies: Bacterial mutagenesis (Ames test), in vitro forward cell mutation assay in V79 cells (HGPRT), chromosomal aberration assay in human lymphocytes, unscheduled and replicating DNA synthesis in rat liver, and in vivo mouse and rat micronucleus tests.
  • In a rat fertility study, repaglinide was administered to male and female rats at doses up to 300 and 80 mg/kg/day, respectively. No adverse effects on fertility were observed (which are over 60 times clinical exposure on a mg/m basis).
  • No data
  • Repaglinide Tablets, USP are supplied as round tablets with beveled edges on both sides available in 0.5 mg (white, debossed with u201cP240u201d on one side), 1 mg (yellow, debossed with u201cP241u201d on one side) and 2 mg (pink, debossed with u201cP242u201d on one side) strengths.
  • Store at 20u00b0 to 25u00b0 C (68u00b0 to 77u00b0 F) [see USP Controlled Room Temperature].
  • Protect from moisture. Keep bottles tightly close.
  • Dispense in tight containers with safety closures.
  • Hypoglycemia
  • Inform patients that repaglinide tablets can cause hypoglycemia and instruct patients and their caregivers on self-management procedures including glucose monitoring and management of hypoglycemia. Inform patients that their ability to concentrate and react may be impaired as a result of hypoglycemia. In patients at higher risk for hypoglycemia and patients who have reduced symptomatic awareness of hypoglycemia, increased frequency of blood glucose monitoring is recommended n
  • Administration
  • Instruct patients to take repaglinide tablets within 30 minutes before meals. Instruct patients to skip their dose of repaglinide tablets when a meal is skipped. n
  • Drug Interactions
  • Discuss potential drug interactions with patients and inform them of potential drug-drug interactions with repaglinide tablets. n
  • Manufactured By
  • Perrigou00ae
  • Minneapolis, MN 55427
  • 2203658
  • 8Z400 RC J4
  • Rev 12-19 C
  • Rx Only
  • NDC 0574--05
  • Repagliniden- Tablets, USPn- 0.5 mg
  • 500 Tablets
  • The following image is a placeholder representing the product identifier that is either affixed or imprinted on the drug package label during the packaging operation.
  • Rx Only
  • NDC 0574--05
  • Repagliniden- Tablets, USPn- 1 mg
  • 500 Tablets
  • The following image is a placeholder representing the product identifier that is either affixed or imprinted on the drug package label during the packaging operation.
  • Rx Only
  • NDC 0574--05
  • Repagliniden- Tablets, USPn- 2 mg
  • 500 Tablets
  • The following image is a placeholder representing the product identifier that is either affixed or imprinted on the drug package label during the packaging operation.

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