Omarol Tablet

Omarol is indicated for the treatment of adults with type 2 diabetes.

Omarigliptin is a long-acting inhibitor of the enzyme dipeptidyl peptidase-4 (DPP- 4). DPP-4 rapidly degrades incretin hormones. Incretins lower blood glucose concentrations in response to a meal by increasing insulin and decreasing glucagon levels in a glucose-dependent manner. Thus, Omarigliptin's mechanism of action augments the action of incretin hormones.

Route of administration: Omarigliptin tablets should be taken in oral route.

Recommended dosage: The recommended dose of Omarigliptin is 25 mg once weekly as monotherapy or as add-on therapy for optimisation of glycemic control. If patient misses a dose, advice to take the missed dose as soon as possible and then follow the regular weekly dosing schedule. Never take two doses at one time.

Renal impairment: The dosage in patients with severe renal dysfunction or with end-stage renal failure or in those requiring hemodialysis or peritoneal dialysis should be according to the following:

Severe end-stage kidney failur-

• Men: CrCl>1.9: 12.5 mg once a week
• Women: CrCl >1.4: 12.5 mg once a week.

Use in children and adolescents: Safety and efficacy of omarigliptin in children and adolescents have not been established.

Drug interaction with medication: Omarol interacts with metformin, glimepiride, oral contraceptives and atorvastatin. Other anti-diabetic drugs (in particular, insulin preparation or sulfonylurea) should be used with caution in combination with Omarol, as they may cause hypoglycemia. Precaution must be taken with drugs that enhances the hypoglycemic action (3-blockers, salicylic acid agents, monoamine oxidase inhibitors). Blood glucose level should be carefully monitored when using drugs that attenuate the hypoglycemic action (adrenaline, adrenocorticotropic hormone, thyroid hormone).

Omarigliptin is contraindicated in patients with hypersensitivity to omarigliptin or any other component of this product. It is also contraindicated in severe ketosis, diabetic coma or precoma in type 1 diabetes patients. Omarigliptin is contraindicated in severe infection in which glycemic control is desired by insulin injection, before and after surgery and in patients with severe trauma.

The adverse effects of Omarol are generally well tolerated. The most common side effects are nasopharyngitis, hypoglycemia, constipation, diarrhea, gastrointestinal problem, skin and subcutaneous tissue disorders.

Clinical trials on use of omarigliptin in pregnant women have not been performed. It should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Breastfeeding should be avoided in mothers taking omarigliptin.

Omarol should be administered with caution in following patients or conditions which might cause low blood sugar such as pituitary dysfunction or adrenal insufficiency; malnutrition, starvation, irregular dietary intake, lack of dietary intake or debilitated state; intense muscle movement; excessive alcohol intake and elder person. Caution should be taken in patients engaged in aerial work or operation of an automobile.

No data is available regarding overdose of Omarol. In the event of overdosage, supportive care is advised.

Dipeptidyl Peptidase-4 (DPP-4) inhibitor

Store in a cool (below 30°C) & dry place protected from the light. Keep away from the reach of children.