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Repaglinide and Metformin Hydrochloride

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Overview

What is Repaglinide and Metformin Hydrochloride?

Repaglinide and metformin hydrochloride tablets for oral use contain repaglinide, a glinide, and metformin, a biguanide.

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. Repaglinide is a white to off-white powder with molecular formula CHNO and a molecular weight of 452.6 with the structural formula as shown below. Repaglinide is freely soluble in methanol and ethanol. The pKa of repaglinide in acid is 3.9, and the pKa in amine is 6.0.

Metformin hydrochloride (N,N-dimethylimidodicarbonimidic diamide hydrochloride) is a white to off-white crystalline compound with a molecular formula of CHN•HCl and a molecular weight of 165.63. Metformin HCl is freely soluble in water and is practically insoluble in acetone, ether, and chloroform. The pKa of metformin hydrochloride is 12.4. The pH of a 1% aqueous solution of metformin hydrochloride is 6.68. The structural formula of metformin hydrochloride is:

Repaglinide and metformin hydrochloride tablets contain 1 mg repaglinide with 500 mg metformin HCl (1 mg/500 mg) or 2 mg repaglinide with 500 mg metformin HCl (2 mg/500 mg) formulated with the following inactive ingredients: hypromellose 6cp, magnesium stearate, meglumine, microcrystalline cellulose, polacrillin potassium, poloxamer 188, polyethylene glycol, povidone, sorbitol, talc and titanium dioxide. Iron oxide yellow is present in the 1 mg/500 mg repaglinide and metformin hydrochloride tablets. Iron oxide red and propylene glycol are present in the 2 mg/500 mg repaglinide and metformin hydrochloride tablets.



What does Repaglinide and Metformin Hydrochloride look like?



What are the available doses of Repaglinide and Metformin Hydrochloride?

Tablets:

What should I talk to my health care provider before I take Repaglinide and Metformin Hydrochloride?

How should I use Repaglinide and Metformin Hydrochloride?

Repaglinide and metformin hydrochloride tablets are indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus who are already treated with a glinide and metformin or who have inadequate glycemic control on a glinide alone or metformin alone.

Limitation of Use

Repaglinide and metformin hydrochloride tablets should not be used in patients with type 1 diabetes mellitus or for the treatment of diabetic ketoacidosis.

General Dosage and Administration information

Administer repaglinide and metformin hydrochloride tablets orally 2 to 3 times a day with meals up to a maximum daily dose of 10 mg repaglinide/2500 mg metformin. No more than 4 mg repaglinide/1000 mg metformin should be taken per meal.

Instruct patients to take repaglinide and metformin hydrochloride tablets within 30 minutes before meals. In patients who skip meals, instruct patients to skip the scheduled dose of repaglinide and metformin hydrochloride tablets to reduce the risk of hypogylcemia. In patients who experience hypoglycemia, the dose of repaglinide should be reduced .

Patients Inadequately Controlled with Metformin Monotherapy

The recommended starting dose of repaglinide and metformin hydrochloride tablets 1 mg repaglinide/500 mg metformin twice daily with meals. Gradually increase dose based on glycemic response to reduce the risk of hypoglycemia with repaglinide.

Patients Inadequately Controlled with Glinide Monotherapy

The recommended starting dose of metformin component of repaglinide and metformin hydrochloride tablets is 500 mg metformin twice daily with meals. Gradually increase dose based on glycemic response to reduce gastrointestinal side effects associated with metformin.

Patients Currently Using Repaglinide and Metformin Concomitantly

Initiate repaglinide and metformin hydrochloride tablets at the dose of repaglinide and metformin similar to (but not exceeding) the patient's current doses. Titrate as needed to achieve glycemic control up to the maximum daily dose.


What interacts with Repaglinide and Metformin Hydrochloride?

Sorry No Records found


What are the warnings of Repaglinide and Metformin Hydrochloride?

Sorry No Records found


What are the precautions of Repaglinide and Metformin Hydrochloride?

Sorry No Records found


What are the side effects of Repaglinide and Metformin Hydrochloride?

Sorry No records found


What should I look out for while using Repaglinide and Metformin Hydrochloride?

ID1042

Repaglinide and metformin hydrochloride tablets are contraindicated in patients with:

Post-marketing cases of metformin-associated lactic acidosis have resulted in death, hypothermia, hypotension, and resistant bradyarrhythmias. The onset of metformin-associated lactic acidosis is often subtle, accompanied only by nonspecific symptoms such as malaise, myalgias, respiratory distress, somnolence, and abdominal pain. Metformin-associated lactic acidosis was characterized by elevated blood lactate levels (> 5 mmol/Liter), anion gap acidosis (without evidence of ketonuria or ketonemia), an increased lactate/pyruvate ratio; and metformin plasma levels generally >5 mcg/mL

Risk factors for metformin-associated lactic acidosis include renal impairment, concomitant use of certain drugs (e.g., carbonic anyhydrase inhibitors such as topiramate), age 65 years old or greater, having a radiological study with contrast, surgery and other procedures, hypoxic states (e.g., acute congestive heart failure), excessive alcohol intake, and hepatic impairment.

Steps to reduce the risk of and manage metformin-associated lactic acidosis in these high risk groups are provided in the full prescribing information

If metformin-associated lactic acidosis is suspected, immediately discontinue repaglinide and metformin hydrochloride tablets and institute general supportive measures in a hospital setting. Prompt hemodialysis is recommended


What might happen if I take too much Repaglinide and Metformin Hydrochloride?

Repaglinide

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 is dialyzable using hemodialysis.

Metformin

Overdose of metformin has occurred, including ingestion of amounts greater than 50 grams. Hypoglycemia was reported in approximately 10% of cases, but no causal association with metformin has been established. Lactic acidosis has been reported in approximately 32% of metformin overdose cases Metformin is dialyzable with a clearance of up to 170 mL/min under good hemodynamic conditions. Therefore, hemodialysis may be useful for removal of accumulated drug from patients in whom metformin overdosage is suspected.


How should I store and handle Repaglinide and Metformin Hydrochloride?

Store at 25°C (77°F); excursions permitted to 15-30°C (59-86°F) [see USP Controlled Room Temperature].Repaglinide and metformin hydrochloride tablets are supplied as biconvex tablets available in 1 mg/500 mg (yellow) and 2 mg/500 mg (pink) strengths. 1 mg/500 mg tablets are debossed with 'V41' on one side and 'LU' on the other side and 2 mg/500 mg tablets are debossed with 'V42' on one side and 'LU' on the other side. The tablets are colored to indicate strength.Store at 25°C (77° F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature]. Protect from moisture. Keep bottles tightly closed.Dispense in tight containers with safety closures.Repaglinide and metformin hydrochloride tablets are supplied as biconvex tablets available in 1 mg/500 mg (yellow) and 2 mg/500 mg (pink) strengths. 1 mg/500 mg tablets are debossed with 'V41' on one side and 'LU' on the other side and 2 mg/500 mg tablets are debossed with 'V42' on one side and 'LU' on the other side. The tablets are colored to indicate strength.Store at 25°C (77° F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature]. Protect from moisture. Keep bottles tightly closed.Dispense in tight containers with safety closures.Repaglinide and metformin hydrochloride tablets are supplied as biconvex tablets available in 1 mg/500 mg (yellow) and 2 mg/500 mg (pink) strengths. 1 mg/500 mg tablets are debossed with 'V41' on one side and 'LU' on the other side and 2 mg/500 mg tablets are debossed with 'V42' on one side and 'LU' on the other side. The tablets are colored to indicate strength.Store at 25°C (77° F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature]. Protect from moisture. Keep bottles tightly closed.Dispense in tight containers with safety closures.Repaglinide and metformin hydrochloride tablets are supplied as biconvex tablets available in 1 mg/500 mg (yellow) and 2 mg/500 mg (pink) strengths. 1 mg/500 mg tablets are debossed with 'V41' on one side and 'LU' on the other side and 2 mg/500 mg tablets are debossed with 'V42' on one side and 'LU' on the other side. The tablets are colored to indicate strength.Store at 25°C (77° F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature]. Protect from moisture. Keep bottles tightly closed.Dispense in tight containers with safety closures.