Comet XR 1gm Tablet (Extended Release)

Indications of Comet XR 1gm

Metformin Hydrochloride is indicated as an adjunct to diet and exercise to improve glycemic control in patients with type 2 diabetes. Metformin is also indicated for use in combination therapy with an oral hypoglycemic agent or insulin when diet and exercise does not result in adequate glycemic control.

Pharmaceutical Name

ACME Laboratories Ltd.

Pharmacology

Metformin is a biguanide type oral antihyperglycemic drug used in the management of type 2 diabetes. It lowers both basal and postprandial plasma glucose. Its mechanism of action is different from those of sulfonylureas and it does not produce hypoglycemia. Metformin decreases hepatic glucose production, decreases intestinal absorption of glucose and improves insulin sensitivity by an increase in peripheral glucose uptake and utilization.

Dosage & Administration of Comet XR 1gm

Metformin immediate release tablet: Dosage of Metformin Hydrochloride must be individualized on the basis of both effectiveness and tolerance, while not exceeding the maximum recommended daily doses.

▪ Adult: The usual starting dose of Metformin is 500 mg twice a day or 850 mg once a day, given with meals. Dosage increases should be made in increments of 500 mg weekly or 850 mg every 2 weeks, up to a total of 2000 mg per day, given in divided doses. For those patients requiring additional glycemic control, Glucomin may be given to a maximum daily dose of 2550 mg per day. Doses above 2000 mg may be better tolerated given three times a day with meals.

 ▪ Children: The usual starting dose of Metformin is 500 mg twice a day, given with meals. Dosage increases should be made in increments of 500 mg weekly up to a maximum of 2000 mg per day, given in divided doses. Metformin extended-release tablet: Swallow Metformin XR tablet whole and never crush, cut or chew.

▪ Adult: The usual starting dose of Metformin XR is 500 mg once daily with the evening meal. The dose should be increased in increments of 500 mg weekly, up to a maximum of 2000 mg once daily with the evening meal, alternatively increased to 1000 mg twice daily taken with a meal. Patient receiving Metformin immediate-release tablet may be switched to a Metformin extended-release tablet up to a maximum recommended daily dose.

▪ Children: Metformin extended-release tablet has not been studied in children.

▪ Renal impaired patient: Do not use Metformin in patients with eGFR below 30 mL/min/1.73 m2. Assess the risk/benefit of counting if eGFR falls below 45 mL/min/1.73 m2. The typical treatment period is seven days. Depending on the severity of the infection, this can be done for up to 14 days.

Adults and children over the age of 12:

The recommended should take 200-400 mg (1 to 2 capsules) every day, either in one dose or in two divided doses. A single oral dose of Cefixime 400 mg is suggested for the treatment of uncomplicated cervical/urethral gonococcal infections.

Children (6 month or older): Usually 8 mg/kg/day given as a single dose or in two divided doses or may be given as follows

• ½-1 year: 75 mg daily.
• 1-4 years: 100 mg daily.
• 5-10 years: 200 mg daily.
• 11-12 years: 300 mg daily
• In typhoid fever, the dosage should be 10 mg/kg/day for 14 days.

Children (under 6 months): Cefixime's safety and efficacy in children less than 6 months have not been established.

Interaction of Comet XR 1gm

Co-administration with Carbonic anhydrase (Topiramate, Zonisamide) may increase risk of lactic acidosis. Drugs (Ranolazine, Dolutegravir, Cimetidine) that reduce Metformin clearance may increase the accumulation of Metformin. Alcohol can potentiate the effect of Metformin on lactate metabolism.

Contraindications

Metformin Hydrochloride is contraindicated in patients with severe renal impairment, hypersensitivity to Metformin, acute or chronic metabolic acidosis and diabetic ketoacidosis, with or without coma.

Side Effect

The most common side effects are diarrhea, nausea, vomiting, flatulence, asthenia, indigestion, abdominal discomfort and headache

Pregnancy & Lactation

Published studies have not reported a clear association with metformin and major birth defects, miscarriage, or adverse maternal or fetal outcomes when metformin was used during pregnancy.

Lactation: Metformin is excreted into human breast milk. No adverse effects were observed in breastfed newborns/infants. However, a decision on whether to discontinue breastfeeding should be made or taking into account the benefit of breastfeeding and the potential risk to an adverse effect on the child.

Precautions & Warnings

Metformin Hydrochloride is known to be substantially excreted by the kidney and the risk of Metformin accumulation and lactic acidosis increases with the degree of impairment of renal function. Metformin may lower vitamin B12 levels. It also increases the risk of hypoglycemia when using in combination with insulin or insulin secretagogues.

Therapeutic Class

Biguanides

Storage Conditions

Keep below 30°C temperature, protected from light & moisture. Keep out of the reach of children.

Generic of Comet XR 1gm

Metformin Hydrochloride