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Glypin®

PRESENTATION:

Glypin Tablet 1mg: Light pink, oblong flat bevelled edge tablet embossed ‘COSMOS’ on one side and scored on the other side. Each tablet contains:Glimepiride USP 1mg, Lactose and other excipients. Glypin Tablet 2mg: Light yellow, oblong flat bevelled edge tablet embossed ‘COSMOS’ on one side and scored on the other side. Each tablet contains:Glimepiride USP 2mg, Lactose and other excipients. Glypin Tablet 3mg: Light green, oblong flat bevelled edge tablet embossed ‘COSMOS’ on one side and breakline on the other side. Each tablet contains:Glimepiride USP 3mg, Lactose and other excipients. Glypin Tablet 4mg: Light blue, oblong flat bevelled edge tablet embossed ‘COSMOS’ on one side and scored on the other side. Each tablet contains:Glimepiride USP 4mg, Lactose and other excipients.

CLINICAL PHARMACOLOGY:

Glimepiride is a sulphonylurea that acts mainly by directly stimulating the release of insulin from functioning beta cells of pancreatic islet tissue. To achieve this, it inhibits the ATP potassium channels on the beta cell membrane and potassium efflux. This results in depolarization and calcium influx, calcium-calmodulin binding, kinase activation, and release of insulin containing granules by exocytosis. Pharmacokinetics: Glimepiride has a high protein binding (>99%). Mean dominant serum halflife, which is of relevance for the serum concentrations under multiple-dose conditions, is about 5 to 8 hours. After single-dose radio labelled glimepiride, 58% of the radioactivity was recovered in the urine and 35% in the faeces. No unchanged substance was detected in the urine. Pharmacokinetics were similar in males and females, as well as in young and elderly patients.

USES: Uncomplicated and non-ketonic diabetes mellitus (maturity onset type II diabetes).

 

DOSAGE AND ADMINISTRATION: Usual daily doses in patients with well controlled diabetes are 1 to 4 mg Glypin.

CONTRA-INDICATIONS: Diabetes complicated by keto-acidosis; coma; Raynauds’s disease; pregnancy; gangrene; severe trauma; fever; severe renal/hepatic/thyroid function impairment; juvenile diabetes mellitus; severe and unstable diabetes; severe inflammation. Interactions: Glypin is metabolised by cytochrome p450 2C9 (CYP2C9). This should be taken into account when Glypin is co-administered with inducers (e.g. rifampicin) or inhibitors (e.g. fluconazole) of CYP 2C9.

The following interactions must be considered:

Potentiation of the blood-glucose-lowering effect and thus, in some instances, hypoglycaemia may occur when one of the following drugs is taken, for example: -insulin and other oral antidiabetics -MAO-inhibitors -ACE-inhibitors -miconazole -anabolic steroids and male sex hormones Weakening of the blood-glucose-lowering effect and, thus raised glucose levels may occur when one of the following drugs is taken, for example: -acetazolamide -laxatives (after protracted use) -barbiturates -nicotinic acid (in high doses) -corticosteroids Side effects: GI disturbances; blood dyscrasia; hypoglycaemia; jaundice; skin rashes; hypersensitivity reactions; headache; dizziness; oedema; hyponatraemia; paraesthesia; and photosensitivity. Pregnancy and Lactation: Glypin must not be used in pregnant or breast-feeding women, as safety has not been shown.

PHARMACEUTICAL PRECAUTIONS:

Store in a dry place below 25ºC. Protect from light. Keep all medicines out of the reach of children.

LEGAL CATEGORY: Prescription Only Medicine (POM)

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