Linaglu 5mg

Linaglu 5mg

Category: Tablets
Classification:Antidiabetic Drugs
Product English Name: Linaglu
Product Arabic Name: ليناجلو
Scientific Name English: Linagliptin
Scientific Name Arabic: ليناجليبتين
Product Unit: 30 Tablet
Product Strength: 5 mg

Categories: Antidiabetic Drugs, Tablets

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Additional information

Composition	Each Film Coated Tablet contains: Linagliptin 5 mg. Drug Class: Dipeptidyl peptidase-4 (DPP-4) inhibitor, Antidiabetic.
Pharmacodynamics	Linagliptin reversibly binds to DPP-4 and thus increases the concentrations of incretin hormones. Linagliptin glucose-dependently increases insulin secretion and lowers glucagon secretion, resulting in better glucose homeostasis regulation.
Pharmacokinetics	Absorption: Linagliptin has an absolute oral bioavailability of approximately 30%. It can be taken with or without food. Distribution: The mean apparent volume of distribution at steady-state following a single intravenous dose of linagliptin 5 mg to healthy subjects is approximately 1,110 L, indicating that linagliptin extensively distributes to the tissues. Plasma protein binding of linagliptin is 75% to 99% concentration-dependent. Metabolism: Following oral administration, the majority (about 90%) of linagliptin is excreted unchanged, indicating that metabolism represents a minor elimination pathway. Excretion: Following administration of oral linagliptin, approximately 85% of the administered drug is eliminated via the enterohepatic system (80%) or urine (5%) within 4 days of dosing. Linagliptin has a terminal half-life of about 200 hours at steady state, though the accumulation half-life is about 11 hours.
Before You Start Linaglu Tablets	Tell your doctor if you have: • A history of heart failure. • Any kidney problems.
Indications and Usage	Linaglu is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.
Administration and Dosage	The recommended dosage of linaglu is 5 mg taken orally once daily, with or without food.
Contraindications	Linagliptin is contraindicated in patients with hypersensitivity to linagliptin or any of its components.
Warnings and Precautions	Pancreatitis: Use of linagliptin has been associated with reports of acute pancreatitis, some of which were serious and required urgent medical attention. Hypoglycemia with Concomitant Use with Insulin and Insulin Secretagogues: The risk of hypoglycemia is increased when linagliptin is used in combination with an insulin secretagogue (e.g., sulfonylurea) or insulin. The use of linagliptin in combination with insulin in subjects with severe renal impairment was associated with a higher rate of hypoglycemia. Hypersensitivity Reactions: There have been post-marketing reports of serious hypersensitivity reactions in patients treated with linagliptin. These reactions include anaphylaxis, angioedema, and exfoliative skin conditions. The onset of these reactions occurred predominantly within the first 3 months after initiation of treatment with linagliptin, with some reports occurring after the first dose. Heart Failure: Consider the risks and benefits of linagliptin before initiating treatment in patients at risk for heart failure, such as those with a prior history of heart failure and a history of renal impairment, and monitor patients for signs and symptoms of heart failure during therapy.
Use in Specific Populations	Patients with Renal and Hepatic Impairment: No dosage adjustment is recommended for patients with renal or hepatic impairment. Pregnancy: The use of linagliptin has not been studied in pregnant women. Animal studies do not indicate direct or indirect harmful effects with respect to reproductive toxicity. Lactation: There is no information regarding the presence of linagliptin in human milk, the effects on the breastfed infant, or the effects on milk production. Therefore, the benefits of breastfeeding should be weighed against the mother’s clinical need for linagliptin and the potential risks to the infant from the drug or the underlying maternal condition. Pediatric Usage: The safety and effectiveness of linagliptin have not been established in pediatric patients.
Side Effects/Adverse Reactions	Some side effects that may occur while taking linagliptin include anxiety, blurred vision, chills, cold sweats, confusion, pale or cool skin, dizziness, fast heartbeat, headache, increased hunger, nausea, nightmares, shakiness, slurred speech, unusual tiredness or weakness, and, in rare cases, seizures or loss of consciousness. If you notice any of these symptoms, especially if they are severe or persistent, contact your doctor right away.
Drug Interactions	Inducers of P-glycoprotein or CYP3A4 enzymes: Rifampicin decreased linagliptin exposure, suggesting that the efficacy of linagliptin may be reduced when administered in combination with a strong P-gp or CYP3A4 inducer. Insulin or Insulin Secretagogues: The risk of hypoglycemia is increased when linagliptin is used in combination with an insulin secretagogue (e.g., sulfonylurea) or insulin. Lower dosages may be required to reduce the risk of hypoglycemia. Overdose: There were no reports of overdose during the clinical development program for linagliptin. It is also reasonable to employ supportive measures as dictated by the patient’s clinical status.
Storage Conditions	Store in a dry place below 30° C. Linaglu 5 mg.
Pack Size	2 blisters (Alu/Alu), each blister contains 15 tablets.

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