Zuvog 0.3 mg Tablet

Voglibose Tablets 0.2mg / 0.3mg

Each uncoated tablet contains:

Voglibose……………….0.2mg / 0.3mg

Excipients q.s.

Dosage Form: Tablets.

Dosage Strength: Voglibose 0.2 mg and 0.3 mg per tablet.

4.1 Therapeutic Indication

For improvement of post prandial hyperglycaemia in diabetic mellitus only when diet and/or exercise or oral hypoglycemic drugs or insulin preparations in addition to diet and /or exercise do not result adequate glycemic control.

4.2 Posology and method of administration

ZUVOG is orally administered in a single dose of 0.2 mg three times daily just before or with each meal.

ZUVOG should be administered in conjunction with diet treatment or diet plus a sulphonylurea.

In case of inadequate effect, the single dose may be increased up to 0.3 mg under close observation of the course of the disease.

4.3 Contraindication

• Hypersensitivity to voglibose or to any component of the formulation.
• Diabetic ketoacidosis, diabetic pre-coma.
• Severe infection, before and after surgery, serious trauma.
• Gastrointestinal obstruction or predisposed to it

4.4 Special warnings and precautions for use

Hypoglycaemia

While on voglibose tablets, patients should be instructed and explained to recognize hypoglycaemic symptoms and its management.

Loss of Control of Blood Glucose

When diabetes patients are exposed to stress such as fever, trauma, infection, or surgery, a temporary loss of control of blood glucose may occur. At such times, temporary insulin therapy may be necessary.

4.5 Drugs interactions

Anti-Diabetic Drugs: When voglibose is used in combination with derivative(s) of sulfonylamide, sulfonylurea or biguanide, or with insulin, hypoglycemic symptoms may occur. Therefore, when used in combination with any of these drugs, care should be taken, such as to initiate therapy with lower dosage.

Drugs Affecting Glycemic Control: When voglibose is administered concomitantly with drugs that enhance or diminish the hypoglycemic action of antidiabetic drugs, caution should be taken as this might additionally delay the action of voglibose on the absorption of carbohydrates. Examples of drugs enhancing the hypoglycemic action of antidiabetic drugs include alpha-blockers, salicylic acid preparations, monoamine oxidase inhibitors, and fibrate derivatives. Examples of drugs diminishing the hypoglycemic action of antidiabetic drugs include epinephrine, adrenocortical hormone, and thyroid hormone.

Warfarin: Voglibose does not affect the pharmacokinetics of warfarin; hence, it can be safely administered along with warfarin.

4.6 Use in special populations

Pregnant Women

Pregnancy Category B. The safety of voglibose in pregnancy has not been established. Animal studies do not indicate harmful effects with respect to pregnancy, embryonal or fetal development, parturition or post-natal development. However, no adequate and well controlled studies have been done in pregnant women. Therefore, voglibose should be given to pregnant women only when the potential benefits to the mother outweigh the possible hazards to the fetus.

Lactating Women

Animal studies (e.g., rats) have revealed a suppressive action of voglibose on body weight increase in newborns probably due to suppression of milk production due to reduced carbohydrate absorption. Although the levels of voglibose reached in human milk are exceedingly low, it is recommended that voglibose may not be administered to lactating women. When the administration of voglibose is unavoidable, nursing should be discontinued.

Paediatric Patients

The safety and effectiveness of voglibose in children has not been established. Thus, Zuvog Tablets are not recommended for use in paediatric patients.

Geriatric

Patients Since elderly patients generally have a physiological hypofunction, it is desirable to initiate therapy with lower dosage. Moreover, this drug should be carefully administered under close observation, throughout the course of the disease, with careful attention to the blood sugar level and the onset of gastrointestinal symptoms.

Renal Impairment Patients

Voglibose is poorly absorbed after oral doses and renal excretion is negligible. Thus, in general, no dosage adjustment is required in patients with renal dysfunction.

Effects on ability to drive and use machines

4.7 Effects on ability to drive and use machines

With voglibose, effect on ability to drive a vehicle or operating machinery has not been reported.

4.8 Undesirable effects

• Gastrointestinal: Gastrointestinal adverse events such as diarrhoea, loose stools, abdominal pain, constipation, anorexia, nausea, vomiting, or heartburn may occur with the use of voglibose. Also, abdominal distention, increased flatus, and intestinal obstruction like symptoms due to an increase in intestinal gas may occur with use of voglibose.
• Hypersensitivity: Rash and pruritus may rarely occur. In such cases, voglibose should be discontinued immediately.
• Hepatic: When voglibose is administered to patients with liver cirrhosis, hyperammonia may worsen with the development of constipation followed by disturbance of consciousness.
• Laboratory Tests: Elevation of SGOT (serum glutamate oxaloacetate), SGPT (serum glutamate pyruvate transaminase), LDH (lactate dehydrogenase), alpha-GPT (alpha-glutamate pyruvate transaminase) or alkaline phosphatase may infrequently occur.
• Hypoglycemia: When voglibose is used in combination with other antidiabetic drugs, hypoglycemia may occur (0.1% to <5%).
• Psychoneurologic: Headache may rarely occur.
• Hematologic: Anemia, thrombocytopenia, and leucopoenia may rarely occur.
• Others: Numbness, edema of face, blurred vision, hot flushes, malaise, weakness, hyperkalemia, increased serum amylase, decreased HDL-cholesterol, diaphoresis, or alopecia may occur rarely with the use of voglibose.

Reporting of suspected adverse reactions

Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via email to:medico@zuventus.com

Website: https://www.zuventus.co.in/drug-safety-reporting

4.9 Overdose

Voglibose is unlikely to produce hypoglycemia in overdose, but abdominal discomfort and diarrhoea may occur. If overdose occurs, supportive and symptomatic treatment should be provided.

5.1 Mechanism of Action

Voglibose competitively and reversibly inhibits the alpha glucosidase enzymes (e.g., glucoamylase, sucrase, maltase, and isomaltase) in the brush border of the small intestine. Alpha-glucosidase enzymes are essential for hydrolysis/decomposition of complex carbohydrates (starch, dextrin, polysaccharides, and disaccharides) into simpler carbohydrates (such as glucose/dextrose or fructose). Inhibition of these enzymes leads to delay in the absorption of glucose into the bloodstream resulting in improvement of post-prandial hyperglycemia.

5.2 Pharmacodynamic properties

Voglibose exerts its activity in the intestinal tract. Alpha glucosidase enzyme normally converts complex carbohydrates into simple monosaccharides (glucose) which can be absorbed through the intestine.

The action of voglibose depends on an inhibition of intestinal enzymes (alpha-glucosidase) involved in the degradation of ingested disaccharides, oligosaccharides, and polysaccharides into monosaccharides. Inhibition of these enzyme systems reduces/delays the rate of digestion of complex carbohydrates. As there is delay in digestion of complex carbohydrates, monosaccharides release slowly and hence absorbed more slowly into the blood i.e., less glucose absorption from intestine into the blood circulation. Voglibose, thus dose dependently reduces the postprandial rise in blood glucose level.

Although voglibose reduces the impact of complex carbohydrates on blood sugar level, it does not affect/inhibit absorption of glucose from the intestine.

Alpha-glucosidase inhibitors such as voglibose do not stimulate insulin release and therefore do not result in hypoglycemia. Voglibose improves post-prandial hyperglycemia and thereby lowers abnormally high levels of glycosylated hemoglobin. Voglibose is highly useful in elderly patients or in patients with predominantly post-prandial hyperglycemia.

5.3 Pharmacokinetic properties

Absorption: Voglibose is poorly absorbed after oral doses. Plasma concentrations after oral doses have usually been undetectable. Following repeated administration to healthy subjects (n=6) in a single dose of 0.2 mg, 3 times a day, for 7 consecutive days, voglibose was not detected in plasma or urine. Similarly, when voglibose was administered to healthy male adults (n=10) as a single dose of 2 mg, voglibose was not detected in plasma or urine.

Distribution: After ingestion of voglibose, the majority of active unchanged drug remains in the lumen of the gastrointestinal tract to exert its pharmacological activity.

Metabolism: Voglibose is metabolized by intestinal enzymes and by the microbial flora. Excretion: Voglibose is mainly excreted in the feces.

6.1 Animal Toxicology or Pharmacology

A study demonstrated that voglibose can potentiate CCl4 (carbon tetrachloride) and APAP (acetaminophen) hepatotoxicity in rats by inducing hepatic CYP2E1.

Voglibose is an alpha-glucosidase inhibitor used to manage postprandial blood glucose levels in patients with type 2 diabetes mellitus.

Chemical name: (1S, 2S, 3R, 4S, 5S)-5-(1,3-dihydroxypropan-2-ylamino)-1-(hydroxymethyl) cyclohexane-1,2,3,4-tetrol.

Molecular formula: C₁₀H₂₁NO₇

Molecular mass: 267.28 g/mol.

Structural formula:

8.1 Incompatibilities

Not applicable.

8.2 Shelf-life

Refer on pack

8.3 Packaging information

Zuvog 0.2 / 0. 3: A blister strip of 10 tablets

8.4 Storage and handing instructions

Store below 25°C. Protected from moisture.

• Take this medicine exactly as prescribed by your doctor. Do not change the dose or stop therapy without consulting your doctor.
• Pregnant women and breastfeeding mothers should not use this medicine without doctor consultation.
• Don’t medicine for the treatment of diabetic ketoacidosis or diabetic pre-coma.
• This medicine is not advisable for use in children.
• Avoid use of this medicine during severe infection or before and after surgery or in serious trauma cases.

10/10/2024