XORMET XR

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XORMET XR Product Information Leaflets
Brand Name:
XORMET XR
Generic Name:
Metformin HCI Extended Release

DESCRIPTION:

XORMET XR (Metformin HCl Extended Release) is an oral anti-diabetic medicine that belongs to the group of biguanides.

Metformin, the active ingredient in XORMET XR, reduces hepatic glucose production, increases insulin sensitivity in muscles and delays intestinal glucose absorption.

COMPOSITION:

XORMET XR 500mg: Each extended release tablet contains Metformin HCI B.P. 500mg. XORMET XR 1000mg: Each extended release tablet contains Metformin HCI B.P. 1000mg.

INDICATIONS:

XORMET XR is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.

DOSAGE & ADMINISTRATION:

XORMET XR should be taken once daily with the evening meal. The dosage of XORMET XR must be individualized on the basis of both effectiveness and tolerability, while not exceeding the maximum recommended daily dose of 2000 mg. The starting dose of XORMET XR in patients who are not currently taking metformin is 500 mg once daily, with the evening meal. The dose can be up titrated in 500 mg increments no sooner than every 1-2 weeks if a higher dose of XORMET XR is needed and there are no gastrointestinal adverse reactions. If XORMET XR is considered appropriate for a patient already receiving immediate-release metformin, the patient can be switched to XORMET XR once daily at the same total daily dose, up to 2000 mg once daily. XORMET XR tablets must be swallowed whole and never split, crushed or chewed. If a dose of XORMET XR is missed, patients should be cautioned against taking two doses of 2000 mg the same day. Resume dosing as according to prescribing recommendations. Co-administration of XORMET XR with an insulin secretagogue (e.g., sulfonylurea) or insulin may require lower doses of the insulin secretagogue or insulin to reduce the risk of hypoglycemia.

CONTRAINDICATIONS:

METFORMIN is contraindicated in patients with: • Renal impairment (e.g., serum creatinine levels ≥ 1.5 mg/dl for men, ≥ 1.4 mg/dl for women or abnormal creatinine clearance), which may also result from conditions such as cardiovascular collapse (shock), acute myocardial infarction, and septicemia. Known hypersensitivity to metformin hydrochloride. Acute or chronic metabolic acidosis, including diabetic ketoacidosis. Diabetic ketoacidosis should be treated with insulin.

UNDESIRABLE EFFECTS:

The reported adverse effects of metformin are Diarrhea, nausea, vomiting, flatulence, asthenia, indigestion, abdominal discomfort (abdominal pain & abdominal distention), headache, abnormal stools, hypoglycemia, myalgia, lightheaded, dyspnea, nail disorder, rash, sweating increased, taste disorder, chest discomfort, chills, flu syndrome, flushing, palpitation, constipation, dyspepsia, heart burn, dizziness & upper respiratory tract infection. Patient may have taste disturbances, there may be a weight loss. Skin reactions have been reported rarely. Hypoglycemia is rare with biguanide given alone, although it may occur if other contributing factors or drugs are present.

PRESENTATION:

XORMET XR 500mg tablets: Blister pack of 5 x 10's tablet. XORMET XR 1000mg tablets: Blister pack of 5 x 10's tablet.

PREGNANCY & LACTATION:

Lactic acidosis can occur due to metformin accumulation. The risk increases with conditions such as sepsis, dehydration, excess alcohol intake, hepatic insufficiency, renal impairment, and acute congestive heart failure. The symptoms include malaise, myalgia’s, respiratory distress, increasing somnolence, and nonspecific abdominal distress. Laboratory abnormalities include low pH, increased anion gap and elevated blood lactate. If acidosis is suspected, discontinue XORMET XR and hospitalize the patient immediately. · Conditions associated with hypoxia, such as acute heart failure, recent myocardial infarction. or shock, may increase the risk of lactic acidosis. · Care should be taken in patients with renal impairment. Renal function should be monitored throughout the therapy. If renal dysfunction is anticipated particularly in elderly patients, renal function should be assessed more frequently and drug should be discontinued if evidence of renal impairment is present as it may increase the chance of lactic acidosis. Dehydration may contribute to renal impairment. · Alcohol is known to potentiate the effect of metformin on lactate metabolism. Patients, therefore, should be warned against excessive alcohol intake while receiving XORMET XR. · XORMET XR should generally be avoided in patients with clinical or laboratory evidence of hepatic disease. · Driving: Diabetes Mellitus, its complications and the medications used to treat it, may affect a patient’s’ ability to drive safely. · Owing to the possibility of decreased vitamin B12 absorption, annual monitoring of vitamin B12 concentrations is advisable during long term treatment. · Safety and effectiveness of METFORMIN in pediatric patients under 18 years has not been established. · May also need to be temporarily stopped for examinations using contrast media in some patients (intravascular administration of iodinated contrast materials in radiologic studies can lead to renal failure, metformin should be discontinued prior to, or at the time of the test and not reinstituted until 48 hours afterwards, and only after renal function has been re-evaluated and found to be normal). · Should be discontinued in patients undergoing surgery and only restarted once normal renal function has been established.

Patients should consult with their physician before taking any medicine.