Omari 25.5 mg (omarigliptin)

Description

Indications

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

Pharmacology

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.

Dosage & Administration

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 ecacy of omarigliptin in children and adolescents have not been

established.

Interaction

Drug interaction with medication: Omari 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 Omari, 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).

Contraindications

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.

Side Effects

The adverse effects of Omari are generally well tolerated. The most common side effects are nasopharyngitis,

hypoglycemia, constipation, diarrhea, gastrointestinal problem, skin and subcutaneous tissue disorders.

Pregnancy & Lactation

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.

Precautions & Warnings

Omari should be administered with caution in following patients or conditions which might cause low blood sugar

such as pituitary dysfunction or adrenal insu ciency; 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.

Overdose Effects

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

Therapeutic Class

Dipeptidyl Peptidase-4 (DPP-4) inhibitor

Storage Conditions

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