Linatab M ER 5 mg+1000 mg (Tablet (Extended Release))

Indications

• adjunct to diet and exercise
• improve glycemic control
• type 2 diabetes mellitus

Pharmacology

• inhibitor of DPP-4
• increases concentration of active incretin hormones
• stimulates release of insulin
• decreases secretion of glucagon
• oral antihyperglycemic drug
• lowers basal and postprandial plasma glucose
• decreases hepatic glucose production
• improves insulin sensitivity

Dosage & Administration

• dosage individualized based on effectiveness and tolerability
• maximum recommended dose of 2.5 mg Linagliptin and 1000 mg Metformin Hydrochloride
• dose escalation gradual
• recommended starting dose for patients not treated with Metformin Hydrochloride
• dose adjustment for patients already treated with Metformin Hydrochloride
• recommended starting dose for patients not treated with metformin
• dose adjustment for patients already treated with Metformin
• specific instructions for extended-release tablet

Interaction

• interactions with cationic drugs
• interactions with carbonic anhydrase inhibitors
• interactions with inducers of P-glycoprotein and CYP3A4 enzymes
• interactions with drugs affecting glycemic control

Contraindications

• contraindicated in patients with renal impairment
• contraindicated in acute or chronic metabolic acidosis
• contraindicated in hypersensitivity to Linagliptin or Metformin Hydrochloride

Side Effects

• nasopharyngitis
• diarrhea
• hypoglycemia
• sulfonylureas

Pregnancy & Lactation

• limited studies in pregnant women
• caution in pregnancy
• caution in lactating mothers

Precautions & Warnings

• discontinue in case of lactic acidosis or acute pancreatitis
• temporarily discontinue in certain medical procedures
• monitoring of hematologic parameters
• symptoms and precautions for lactic acidosis
• precautions for alcohol consumption
• precautions for other medicines
• precautions for travel and emergencies
• risk of hypoglycemia

Overdose Effects

• supportive measures for overdose
• removal of unabsorbed material
• clinical monitoring
• supportive treatment
• dialyzable Metformin Hydrochloride
• no dose-related clinical adverse drug reactions

Therapeutic Class

• oral hypoglycemic preparations

Storage Conditions

• keep in cool & dry place
• below 30°C
• protected from light & moisture
• keep out of the reach of children

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