Repaglinide (Prandin)

Trade Name : Prandin

Novo Nordisk

TABLET

Strength 0.5 mg/1

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

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 Repaglinide (Prandin) which is also known as Prandin and Manufactured by Novo Nordisk. It is available in strength of 0.5 mg/1 per ml. Read more

Repaglinide (Prandin) 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!

About GNH

No data

PRANDIN is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.
PRANDIN is a glinide indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus n n
Limitation of Use:

No data

The recommended starting dose is 0.5 mg orally before each meal if HbA1c is less than 8%; and 1 or 2 mg orally before each meal if HbA1c is 8% or greater. (n )n
The recommended dose range is 0.5 mg to 4 mg before meals, with a maximum daily dose of 16 mg. (n )n
The patientu2019s dose should be doubled up to 4 mg with each meal until satisfactory glycemic control is achieved. At least one week should elapse to assess response after each dose adjustment. (n )n
Instruct patients to skip the dose of PRANDIN if a meal is skipped. In patients who experience hypoglycemia, the dose of PRANDIN should be reduced. (n ; n )n
Instruct patients to take PRANDIN within 30 minutes before meals. (n )n
In patients with severe renal impairment (CrCl = 20 u2013 40 mL/min), recommended starting dose is 0.5 mg orally before each meal. (n )n
Dose modifications are required when used concominantly with some medications. (n ,n )n

Tablets: 0.5 mg, 1 mg, 2 mg (n )n

PRANDIN is contraindicated in patients with:

Concomitant use with gemfibrozil (n )n
Known hypersensitivity to repaglinide or any inactive ingredients (n )n

No data

Hn- yn- pn- on- gn- lycemia
Sn- en- rn- ious Cardiovascular Adverse Reactions with Concomitant NPH-insulin
Macrovascular outcomes

The following serious adverse reaction is also described elsewhere in the labeling:
Hypoglycemia n n
The most common adverse reactions (5% or greater incidence) among patients treated with PRANDIN were: hypoglycemia, upper respiratory infection, headache, sinusitis, arthralgia, nausea, diarrhea, and back pain. (n )n
To report SUSPECTED ADVERSE REACTIONS, contact Gemini Laboratories, LLC at (855) 346-8326 or FDA at 1-800-FDA-1088 or n . n

Clinically Important Drug Interactions with PRANDIN
Table 3 includes a list of drugs with clinically important drug interactions when administered concomitantly with PRANDIN and instructions for preventing or managing them.

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 PRANDIN
Drn- un- gn- s That May Blunt Signs and Symptoms of Hypoglycemia

No data

Lactation: PRANDIN is not recommended when breastfeeding (n )n

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 PRANDIN is dialyzable using hemodialysis.

PRANDIN (repaglinide) is an oral blood glucose-lowering drug of the glinide class. Repaglinide, S(+)2-ethoxy-4(2((3-methyl-1-(2-(1u00ad 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 Cn Hn Nn On and a molecular weight of 452.6. PRANDIN tablets contain 0.5 mg, 1 mg or 2 mg of repaglinide. In addition, each tablet contains the following inactive ingredients: calcium hydrogen phosphate (anhydrous), microcrystalline cellulose, maize starch, polacrilin potassium, povidone, glycerol (85%), magnesium stearate, meglumine and poloxamer. The 1 mg and 2 mg tablets contain iron oxides (yellow and red, respectively) as coloring agents.n

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/m2 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/mn 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/mn basis).n
Repaglinide was non-genotoxic in a battery of n n and n n studies: Bacterial mutagenesis (Ames test), n n forward cell mutation assay in V79 cells (HGPRT), n n chromosomal aberration assay in human lymphocytes, unscheduled and replicating DNA synthesis in rat liver, and n n mouse and rat micronucleus tests.n
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/mn basis).n

No data

PRANDIN (repaglinide) tablets are supplied as biconvex tablets available in 0.5 mg (white), 1 mg (yellow) and 2 mg (peach) strengths.
All strengths of Prandin are not being marketed.
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.

Hy
p
og
l
y
cemia
Inform patients that PRANDIN 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 n n
Administration
Instruct patients to take PRANDIN within 30 minutes before meals. Instruct patients to skip their dose of PRANDIN when a meal is skipped. n .n
Drug Interactions
Discuss potential drug interactions with patients and inform them of potential drug-drug interactions with PRANDIN. n n n n n
PRANDINn is a registered trademark of Gemini Laboratories, LLC.n
Rev. 01-2019-00
Manufactured for:n nGemini Laboratories, LLCn nBridgewater, NJ 08807n
For information contact:n nGemini Laboratories, LLC atn n(855) 346-8326 or FDA atn n1-800-FDA-1088 orn n n

0.5 mg Tablet
NDC 0169-0081-81
List 008181
Prandinn n n n
(repaglinide) Tablets
0.5
100 Tablets

1 mg Tablet
NDC 0169-0082-81
List 008281
Prandinn n n n
(repaglinide) Tablets
1
100 Tablets

2 mg Tablet
NDC 0169-0084-81
List 008481
Prandinn n n n
(repaglinide) Tablets
2
100 Tablets

Browse Our Services And Processes

Comparator Sourcing for Clinical Trials

GNH India brings over 10 years of experience in Comparator

Name Patient Supply

Today, the exact cause for many rare diseases remains unknown

Validated Cold Chain Shipment

With shifting of pharma industry from synthetic molecules to biologic

Clinical Trials Supply

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

Pharmaceutical Contract Manufacturing

GNH Provides Contract Manufacturing services for: Generic Medicines with following

Pricing

PRICING POLICY Terms of sales are typically prepaid, unless otherwise

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

71245 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?

Get Price

Repaglinide (Prandin)

Trade Name : Prandin

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)

Browse Our Services And Processes

Disclaimer

Browse from other international pharmaceuticals

General

US NDC

Canadian DIN

Swiss Drugs

NZ Drugs

FAQ

Can’t find what
you’re looking for?

COMPANY

SERVICES

QUICK LINKS

CONTACT US

Repaglinide (Prandin)

Trade Name : Prandin

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)

Browse Our Services And Processes

Disclaimer

Browse from other international pharmaceuticals

General

US NDC

Canadian DIN

Swiss Drugs

NZ Drugs

FAQ

Can’t find what you’re looking for?

COMPANY

SERVICES

QUICK LINKS

CONTACT US

Can’t find what
you’re looking for?