PRANDIN Tablet (2019)
Βιβλιογραφική αναφορά
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Amneal Pharmaceuticals LLC
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1. Indications and Usage
PRANDIN is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. <u>Limitation of Use:</u> PRANDIN should not be used in patients with type 1 ...
2. Dosage and Administration
2.1 Recommended Dosage and Administration The recommended starting dose for patients whose HbA<sub>1c</sub> is less than 8% is 0.5 mg orally before each meal. For patients whose HbA<sub>1c</sub> is 8% ...
3. Dosage Forms and Strengths
1 mg tablets (yellow, round, biconvex tablets, debossed with 745 on one side and C on the other side) 2 mg tablets (pink, round, biconvex tablets, debossed with 747 on one side and C on the other side) ...
4. Contraindications
PRANDIN is contraindicated in patients with: Concomitant use of gemfibrozil <em>[see Drug Interactions (7)]</em> Known hypersensitivity to repaglinide or any inactive ingredients
5. Warnings and Precautions
5.1 Hypoglycemia All glinides, including PRANDIN, can cause hypoglycemia <em>[see Adverse Reactions (6.1)]</em>. Severe hypoglycemia can cause seizures, may be life-threatening, or cause death. Hypoglycemia ...
6. Adverse Reactions
The following serious adverse reaction is also described elsewhere in the labeling: Hypoglycemia <em>[see Warnings and Precautions (5.1)]</em>
6.1. Clinical Trials Experience
Because clinical trials are conducted under widely varying designs, the adverse reaction rates reported in one clinical trial may not be easily compared to those rates reported in another clinical trial, ...
6.2. Postmarketing Experience
The following additional adverse reactions have been identified during post approval use of PRANDIN. Because these reactions are reported voluntarily from a population of uncertain size, it is generally ...
7. Drug Interactions
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 ...
8.1. Pregnancy
Risk Summary Limited data with PRANDIN and repaglinide use in pregnant woman are insufficient to inform a drug-associated risk for major birth defects or miscarriage. There are risks to the mother and ...
8.2. Lactation
Risk Summary There is no information regarding the presence of PRANDIN in human milk, the effects on the breastfeeding infant, or the effects on milk production. Repaglinide was detected in rat milk, though ...
8.4. Pediatric Use
Safety and effectiveness have not been established in pediatric patients.
8.5. Geriatric Use
In clinical studies of 24 weeks or greater duration, 415 patients were over 65 years of age and no patients were greater than 75 years of age. In one-year, active-controlled trials, no differences were ...
8.6. Renal Impairment
Pharmacokinetic studies of repaglinide were conducted in patients with mild to moderate renal function impairment (CrCl = 40 to 80 mL/min), and severe renal function impairment (CrCl = 20 to 40 mL/min). ...
8.7. Hepatic Impairment
A single-dose study was conducted 12 patients with chronic liver disease. Patients with moderate to severe impairment of liver function had higher and more prolonged serum concentrations. Therefore, PRANDIN ...
10. Overdosage
Severe hypoglycemic reactions with coma, seizure, or other neurological impairment may occur and constitute medical emergencies requiring immediate hospitalization. Hypoglycemic symptoms without loss of ...
11. Description
PRANDIN (repaglinide) is 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 ...
12.1. Mechanism of Action
Repaglinide lowers blood glucose levels by stimulating the release of insulin from the pancreas. This action is dependent upon functioning beta (β) cells in the pancreatic islets. Insulin release is glucose-dependent ...
12.2. Pharmacodynamics
A four-week, double-blind, placebo-controlled dose-response trial was conducted in 138 patients with type 2 diabetes using doses ranging from 0.25 (not an approved dose) to 4 mg taken with each of three ...
12.3. Pharmacokinetics
The pharmacokinetic parameters of repaglinide obtained from a single-dose, crossover study in healthy subjects and from a multiple-dose, parallel, dose-proportionality (0.5, 1, 2 and 4 mg) study in patients ...
13.1. Carcinogenesis, Mutagenesis, Impairment of Fertility
In a 104-week carcinogenicity study in rats at doses up to 120 mg/kg/day, which is approximately 60 times clinical exposure on a mg/m² basis, the incidences of benign adenomas of the thyroid and liver ...
14. Clinical Studies
14.1 Monotherapy Trials A double-blind, placebo-controlled trial was carried out in 362 patients treated for 24 weeks. HbA<sub>1c</sub> for the PRANDIN- treated groups (1 and 4 mg groups combined) at the ...
16.1. How Supplied
PRANDIN (repaglinide) tablets, <b>1 mg</b>, are supplied as yellow, round, biconvex tablets, debossed with 745 on one side and C on the other side. They are available as follows: Bottles of 100 NDC 60846-882-01 ...
16.2. Storage and Handling
Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Protect from moisture. Keep bottles tightly closed. Dispense in tight containers with safety closures.
17. Patient Counseling Information
Hypoglycemia 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 ...