INHIBAMET 12.5/1000MG 30TAB alogliptin, metformin, blood glucose regulators .
INHIBAMET 12.5/1000MG 30TAB
ACTIVE-INGREDIENT OF INHIBAMET 12.5/1000MG 30TAB
Each tablet contains: 12.5 mg of Alogliptin and 1000 mg of Metformin hydrochloride
INDICATION OF INHIBAMET 12.5/1000MG 30TAB
1- Monotherapy and Combination therapy: INHIBAMET is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus when treatment with both alogliptin and metformin is appropriate.
2- Limitations of use: INHIBAMET should not be used in patients with type 1 diabetes mellitus or for the treatment of ketoacidosis, as it would not be effective in these settings.
DOSAGE OF INHIBAMET 12.5/1000MG 30TAB
Follow all directions given to you by your pharmacist or doctor carefully . They may differ from the information contained in this leaflet
Ask your pharmacist or doctor for help if you do not understand the instructions on the box .
The recommended dose is : –
Recommendations for all patients: Healthcare providers should individualize the starting dose of INHIBAMET based on the patient’s current regimen. INHIBAMET should be taken twice daily with food with gradual dose escalation to reduce the gastrointestinal (GI) side effects due to metformin. INHIBAMET tablets must not be split before swallowing. Dosing may be adjusted based on effectiveness and tolerability while not exceeding the maximum recommended daily dose of 25 mg alogliptin and 2000 mg metformin HCl. The following doses are available: 12.5 mg alogliptin and 500 mg metformin HCl, 12.5 mg alogliptin and 1000 mg metformin HCl.
OVER-DOSAGE OF INHIBAMET 12.5/1000MG 30TAB
Alogliptin: The highest doses of administered in clinical trials were single doses of 800 mg to healthy subjects and doses of 400 mg once daily for 14 days to patients with type 2 diabetes ( equivalent to 32 times and 16 times rhe recommended clinical dose, of 25 mg respectively). No serious adverse reactions were observed at these doses. In the event of overdose, it is reasonable to institute the necessary clinical monitoring and supportive therapy as dictated by the patient’s clinical status. Per clinical judgment, it may be reasonable to initiate removal of unabsorbed material from the gastrointestinal tract. Alogliptin is minimally dialyzable; over a three-hour hemodialysis session, approximately 7% of the drug was removed. Therefore, hemodialysis is unlikely to be beneficial in an overdose situation. It is known if alogliptin is dialyzable by peritoneal dialysis.
Metformin hydrochloride:
Overdose of metformin has occurred, including ingestion of amounts greater than 50 grams . Hypoglycemia was reported in approximately 10% of cases, but no causal association with metformin has been established. Lactic acidosis has been reported in approximately 32% of metformin overdose cases . Metformin is dialyzable with a clearance of up to 170 mL/min under good hemodynamic conditions. Therefore, hemodialysis may be useful for removal of accumulated drug from patients in whom metformin overdosage is suspected.
CONTRA-INDICATION OF INHIBAMET 12.5/1000MG 30TAB
INHIBAMET is contraindicated in patients with: Renal impairment ( e.g., serum creatinine levels ≥ 1.5 mg/dL for men, ≥ 1.4 mg/dL for women or abnormal creatinine clearance), which may also result from conditions such as cardiovascular collapse (shock), acute myocardial infarction and septicemia. Acute or chronic metabolic acidosis, including diabetic ketoacidosis. diabetic ketoacidosis should be treated with insulin. History of a serious hypersensitivity reaction to alogliptin or metformin, components of INHIBAMET, such as anaphylaxis, angioedema or severe cutaneous adverse reactions.
STORAGE OF INHIBAMET 12.5/1000MG 30TAB
Store at temperature not exceeding 30 ° C in a dry place. Keep out of reach of children.
PACK OF INHIBAMET 12.5/1000MG 30TAB
Carton box containing 1, 2 or 3 (AL/opaque aclar) blisters each of 10 film coated tablets + insert leaflet.
INHIBAMET 12.5/1000MG 30TAB MANUFACTURED BY
Hikma Pharma S.A.E. – 6 October City – Egypt.
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