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Sivoformin

Adpharm Pharmaceuticals Limited
60, Ajao Road, Surulere, Lagos State, Nigeria
Email: adpharm2010@yahoo.com; info@adpharmltd.com
Tel: +234(0)818-839-0519, +234(0)807-408-4334. Mobile: 08033481022
Website: http://adpharmltd.com/

Brand Name

Sivoformin

Manufacturer

Globela Pharma Pvt. Ltd 357, G.I.D.C., Sachin Surat -394 230. Gujarat. (India) www.globelapharma.com Mfg. Lic. No. : G/25/1749

Therapeutic Class

Antidiabetic, Biguanides

Dosage Form, Composition & NAFDAC Registration Number (NRN)

Tablet (NRN: B4-0487): Metformin Hydrochloride BP 500 mg.

Excipients q.s.

Pack size: 10 Tablets Alu - PVC blister packed, such 10 blister packed in one carton. 

Sivoformin Tablet

Pharmacology

PHARMACOLOGICAL CLASSIFICATION:

A 21.2 - Oral Hypoglycaemic.

PHARMACOLOGICAL ACTION:

SIVOFORMIN is a biguanide oral anti-hyperglycaemic agent. Its mode of action is thought to be multifactorial and includes delayed uptake of glucose from the gastrointestinal tract, increased peripheral glucose utilisation mediated by increased insulin sensitivity, and inhibition of increased hepatic and renal gluconeogenesis. No hypoglycaemia occurs when SIVOFORMIN is used alone but can occur when given concomitantly with a sulphonylurea, insulin or alcohol.

IDENTIFICATION: SIVOFORMIN 500 mg Tablets - White, round, uncoated tablets.

Indications

Non-insulin dependent diabetes when diet has failed and especially if the patient is overweight.

SIVOFORMIN can be given alone as initial therapy, or can be administered in combination with a sulphonylurea.

In insulin-dependent diabetes, SIVOFORMIN may be given as an adjuvant to patients whose symptoms are poorly controlled.

Contra-indications

Sensitivity to metformin hydrochloride. Diabetic coma and ketoacidosis, impairment of renal function, chronic liver disease, cardiac failure and recent myocardial infarction. History of, or states associated with, lactic acidosis such as shock or pulmonary insufficiency, alcoholism (acute or chronic), and conditions associated with hypoxemia.  Pancreatitis.  The use of SIVOFORMIN during pregnancy is not advised. There is no information available concerning the safety of SIVOFORMIN during lactation.

Precautions/Warnings

Sensitivity to metformin hydrochloride. Diabetic coma and ketoacidosis, impairment of renal function, chronic liver disease, cardiac failure and recent myocardial infarction . History  of, or states associated with, lactic acidosis such as shock or pulmonary insufficiency, alcoholism (acute or chronic), and conditions associated with hypoxemia. Pancreatitis. The use of SIVOFORMIN during pregnancy is not advised. There is no information available concerning the safety of SIVOFORMIN during lactation.

Interactions

Adverse Effects

Gastro-intestinal adverse effects with anorexia, nausea and vomiting.

Metallic taste.

Lactic acidosis has been associated with SIVOFORMIN but, has occurred to a greater extent in patients with contra-indications to therapy. In patients with a metabolic acidosis lacking evidence of ketoacidosis (ketonuria and ketonaemia) lactic acidosis should be suspected and SIVOFORMIN therapy stopped. Lactic acidosis is a medical emergency which must be treated in hospital.

SIVOFORMIN is excreted by the kidney and regular monitoring of renal function is advised in all diabetics. SIVOFORMIN therapy should be stopped 2-3 days before surgery and clinical investigations such as intravenous urography and intravenous angiography and reinstated only after control of renal function has been regained.

The use of SIVOFORMIN is not advised in conditions which may cause dehydration or in patients suffering from serious infections, trauma or on low calorie intake. Patients receiving continuous SIVOFORMIN therapy should have an annual estimation of Vitamin B12 levels because of reports of decreased Vitamin B12 absorption. During concomitant therapy with a sulphonylurea, blood glucose should be monitored because combined therapy may cause hypoglycaemia.

Stabilisation of diabetic patients with SIVOFORMIN and insulin should be carried out in hospital because of the possibility of hypoglycaemia until the correct ratio of the two drugs has been obtained. Reduced renal clearance of SIVOFORMIN has been reported during cimetidine therapy, so a dose reduction should be considered.

An interaction between SIVOFORMIN and anticoagulants is a possibility and dosage of the latter may need adjustment Contra-indications should be carefully observed.

KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT:

Hypoglycaemia can occur when SIVOFORMIN is given concomitantly with a sulphonylurea, insulin or alcohol. In excessive dosage, and particularly if there is a possibility of accumulation, lactic acidosis may develop. Intense symptomatic and supportive therapy is recommended which should be particularly directed al correcting fluid loss and metabolic disturbance.

Dosage & Administration

It is important that SIVOFORMIN tablets be taken in divided doses with meals.

Adults: Initially, one 850 mg tablet twice a day or one 500 mg tablet three times a day, with or after food. Good diabetic control may be achieved within a few days, but it is not usual for the full effect to be delayed for up to two weeks.

If control is incomplete a cautious increase in dosage to a maximum of 3 g daily is justified. Once control has been obtained it may be possible to reduce the dosage of metformin. 

Children: SIVOFORMIN is not recommended for use.

Elderly: SIVOFORMIN is indicated in the elderly, but not when renal function is impaired.

Combination therapy - see "Special Precautions"

Storage/Handling Recommendations

Store in cool and dry place, Protect from light and moisture. Keep out of reach of children.

Review Date

2017-08-17 01:55:30