Adlinameg 2.5mg+850mg

Tablet
Linagliptin + Metformin Hydrochloride
Unimed Unihealth MFG. Ltd

Other Strength:
- Adlinameg 2.5mg+500mg

Alternative:
- Linamet 2.5mg+850mg
- Glitin M 2.5mg+850mg
- Liglimet 2.5mg+850mg
- Lino-M 2.5mg+850mg



Adlinameg
Presentation

Adlinameg 2.5/500 tablet: Pink, oblong shaped, film coated tablet; each tablet contains Linagliptin INN 2.5mg & Metformin Hydrochloride BP 500mg

Adlinameg 2.5/850 tablet: Pink, oblong shaped, film coated tablet; each tablet contains Linagliptin INN 2.5mg & Metformin Hydrochloride BP 850mg

Indications

Treatment of adult patients with type 2 diabetes mellitus: Adlinameg is indicated as an adjunct to diet and exercise to improve glycaemic control in adult patients inadequately controlled on their maximal tolerated dose of metformin alone, or those already being treated with the combination of linagliptin and metformin. Adlinameg is indicated in combination with a sulphonylurea (i.e. triple combination therapy) as an adjunct to diet and exercise in adult patients inadequately controlled on their maximal tolerated dose of metformin and a sulphonylurea. Adlinameg is indicated in combination with insulin (i.e. triple combination therapy) as an adjunct to diet and exercise to improve glycaemic control in adult patients when insulin and metformin alone do not provide adequate glycaemic control.

Dosage and administration

The dose of antihyperglycaemic therapy with Adlinameg should be individualised on the basis of the patient’s current regimen, effectiveness, and tolerability, while not exceeding the maximum recommended daily dose of 5 mg linagliptin plus 2000 mg of metformin hydrochloride.

For patients inadequately controlled on maximal tolerated dose of metformin monotherapy: For patients not adequately controlled on metformin alone, the usual starting dose of Adlinameg should provide linagliptin dosed as 2.5 mg twice daily (5 mg total daily dose) plus the dose of metformin already being taken.

For patients switching from co-administration of linagliptin and metformin: For patients switching from co-administration of linagliptin and metformin, Adlinameg should be initiated at the dose of linagliptin and metformin already being taken.

For patients inadequately controlled on dual combination therapy with the maximal tolerated dose of metformin and a sulphonylurea : The dose of Adlinameg should provide linagliptin dosed as 2.5 mg twice daily (5 mg total daily dose) and a dose of metformin similar to the dose already being taken. When linagliptin plus metformin hydrochloride is used in combination with a sulphonylurea, a lower dose of the sulphonylurea may be required to reduce the risk of hypoglycaemia

For patients inadequately controlled on dual combination therapy with insulin and the maximal tolerated dose of metformin: The dose of Adlinameg should provide linagliptin dosed as 2.5 mg twice daily (5 mg total daily dose) and a dose of metformin similar to the dose already being taken. When linagliptin plus metformin hydrochloride is used in combination with insulin, a lower dose of insulin may be required to reduce the risk of hypoglycaemia .

Elderly: As metformin is excreted by the kidney, Adlinameg should be used with caution as age increases. Monitoring of renal function is necessary to aid in prevention of metformin-associated lactic acidosis, particularly in the elderly). Clinical experience with patients > 80 years of age is limited and caution should be exercised when treating this population.

Renal impairment: Adlinameg must not be used in patients with moderate or severe renal impairment (creatinine clearance < 60 ml/min) due to the active substance metformin

Hepatic impairment: Adlinameg is not recommended in patients with hepatic impairment due to the active substance metformin. Clinical experience with Adlinameg in patients with hepatic impairment is lacking.

Paediatric population: The safety and efficacy of Adlinameg in children and adolescents aged 0 to 18 years have not been established. No data are available.

Adlinameg should be taken twice daily with meals to reduce the gastrointestinal adverse reactions associated with metformin. All patients should continue their diet with an adequate distribution of carbohydrate intake during the day. Overweight patients should continue their energy-restricted diet.

If a dose is missed, it should be taken as soon as the patient remembers. However, a double dose should not be taken at the same time. In that case, the missed dose should be skipped.

Contra-indications, warning etc.

Hypersensitivity to the active substances or to any of the excipients

Diabetic ketoacidosis, diabetic pre-coma.
Renal failure or renal dysfunction (creatinine clearance < 60 ml/min).
Acute conditions with the potential to alter renal function such as: dehydration, severe infection, shock.
Disease which may cause tissue hypoxia (especially acute disease, or worsening of chronic disease) such as: decompensated heart failure, respiratory failure, recent myocardial infarction, shock
Hepatic impairment, acute alcohol intoxication, alcoholism.

General: Adlinameg should not be used in patients with type 1 diabetes or for the treatment of diabetic ketoacidosis.

Hypoglycaemia: When linagliptin was added to a sulphonylurea on a background of metformin, the incidence of hypoglycaemia was increased over that of placebo.

Sulphonylureas and insulin are known to cause hypoglycaemia. Therefore, caution is advised when Adlinameg is used in combination with a sulphonylurea and/or insulin. A dose reduction of the sulphonylurea or insulin may be considered.

Hypoglycaemia is not identified as adverse reaction for linagliptin, metformin, or linagliptin plus metformin. In clinical trials, the incidence rates of hypoglycemia were comparably low in patients taking linagliptin in combination with metformin or metformin alone.

Lactic acidosis: Lactic acidosis is a very rare, but serious (high mortality rate in the absence of prompt treatment), metabolic complication that can occur due to metformin accumulation. Reported cases of lactic acidosis in patients on metformin have occurred primarily in diabetic patients with impaired renal failure or acute worsening of renal function. Special caution should be paid to situations where renal function may become impaired, for example in case of dehydration (severe diarrhoea or vomiting), or when initiating antihypertensive therapy or diuretic therapy and when starting therapy with a non-steroidal anti-inflammatory drug (NSAID). In the acute conditions listed, Adlinameg should be temporarily discontinued.

Renal function: As metformin hydrochloride is excreted by the kidney, serum creatinine levels should be determined before initiating treatment and regularly thereafter:

at least annually in patients with normal renal function,
at least two to four times a year in patients with serum creatinine levels at or above the upper limit of normal and in older subjects.

In case CrCl is < 60 ml/min, Adlinameg is contraindicated

Cardiac function: Patients with heart failure are more at risk of hypoxia and renal impairment. In patients with stable chronic heart failure, Adlinameg may be used with a regular monitoring of cardiac and renal function. For patients with acute and unstable heart failure, Adlinameg is contraindicated .

Elderly: Caution should be exercised when treating patients 80 years and older

Drug interactions: Clinical data described suggest that the risk for clinically meaningful interactions by co-administered medicinal products is low. Metformin: Co-administration of multiple three times daily doses of 850 mg metformin with 10 mg Linagliptin once daily did not clinical meaningfully alter the pharmacokinetics of Linagliptin in healthy volunteers. Sulphonylureas: The steady-state pharmacokinetics of 5 mg Linagliptin was not changed by concomitant administration of a single 1.75 mg dose glibenclamide (glyburide). In clinical studies, Linagliptin had no clinically relevant effect on the pharmacokinetics of metformin, glyburide, simvastatin, warfarin, digoxin or oral contraceptives providing in vivo evidence of a low propensity for causing medicinal product interactions with substrates of CYP3A4, CYP2C9, CYP2C8, P-glycoprotein, and organic cationic transporter (OCT).

Pregnancy: Adlinameg should not be used during pregnancy. If the patient plans to become pregnant, or if pregnancy occurs, treatment with Adlinameg should be discontinued and switched to insulin treatment as soon as possible in order to lower the risk of foetal malformations associated with abnormal blood glucose levels.

Breast-feeding: Studies in animals have shown excretion of both metformin and linagliptin into milk in lactating rats. Metformin is excreted in human milk in small amounts. It is not known whether linagliptin is excreted into human milk. A decision must be made whether to discontinue breast-feeding or to discontinue/abstain from Adlinameg therapy taking into account the benefit of breast-feeding for the child and the benefit of therapy for the woman.

Fertility: No studies on the effect on human fertility have been conducted for Adlinameg. No adverse effects of linagliptin on fertility were observed in male or female rats

Effects on ability to drive and use machines: Adlinameg has no or negligible influence on the ability to drive and use machines.

Adverse reactions: Fixed dose combination: The most frequently reported adverse reaction for linagliptin plus metformin was diarrhoea

Adverse reactions reported when linagliptin and metformin were combined with sulphonylurea: In one study linagliptin was given as add-on to metformin plus sulphonylurea. When linagliptin and metformin were administered in combination with a sulphonylurea, hypoglycaemia was the most frequently reported adverse event (linagliptin plus metformin plus sulphonylurea 23.9% and 16.0% in placebo plus metformin plus sulphonylurea).

Adverse reactions reported when linagliptin and metformin were combined with insulin: When linagliptin and metformin were administered in combination with insulin, hypoglycaemia was the most frequently reported adverse event.

Description of selected adverse reactions: Gastrointestinal disorders such as, nausea, vomiting, diarrhoea and decreased appetite and abdominal pain occur most frequently during initiation of therapy with Adlinameg or metformin hydrochloride and resolve spontaneously in most cases. For prevention, it is recommended that Adlinameg be taken in 2 daily doses during or after meals.

Overdose: No data are available with regard to overdose of Adlinameg.

Pharmaceutical precautions

Store in a cool and dry place, protected from light.

Packaging quantity

Adlinameg 2.5/500 tablet : Cartons containing 30 tablets in Alu-Alu blister.

Adlinameg 2.5/850 tablet : Cartons containing 30 tablets in Alu-Alu blister.

Manufactured by

UniMed & UniHealth Manufacturers Ltd.

B K Bari, Gazipur, Bangladesh

® Registered Trademark


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