Siglimet 50 mg+500 mg (Tablet)

Title

• Combination Oral Hypoglycemic Tablet

Categories

• Medicine
• Diabetes Management
• Pharmaceuticals

Description

• Adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus
• Combines two antihyperglycemic agents with complementary mechanisms of action
• Individualized dosage based on patient's current regimen and tolerability
• Pregnancy category B, caution during lactation
• Contraindicated in patients with renal disease, acute or chronic metabolic acidosis, and history of serious hypersensitivity reaction

Dimensions

• Film-coated tablet
• Extended-release tablet

Color Options

Functions

• Improves glycemic control
• Decreases hepatic glucose production
• Increases peripheral glucose uptake and utilization
• Monitors and adjusts dosages for patients treated with metformin and insulin
• Supportive measures for overdose

Materials

• Sitagliptin
• Metformin HCl
• Biguanide class

Technical Specifications

• Maximum recommended daily dose of 100 mg sitagliptin and 2000 mg metformin
• Administered twice daily with meals
• Monitor INR levels when co-administered with phenprocoumon
• Interactions with cationic drugs and levothyroxine
• Store below 25°C in a dry place away from light

Design Elements

• Film-coated
• Gastrointestinal (GI) side effects reduction
• Gradual dose escalation for extended-release tablet
• Provided as single tablet once daily for specific dosages

Usability Features

• Can be individually dosed based on the patient's current regimen
• Caution exercised when administered to a nursing woman
• Caution during radiologic studies involving intravascular administration of iodinated contrast materials

Dosage & Administration

• Individualized dosing based on patient's current regimen
• Maximum recommended daily dose of 100 mg sitagliptin and 2000 mg metformin
• Dosage adjustment with extended-release tablet
• Twice daily administration with meals
• Assessment of renal function before and during treatment

Indications

• Adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus
• Not to be used in patients with type 1 diabetes or for the treatment of diabetic ketoacidosis
• Not studied in patients with a history of pancreatitis

Interactions

• Cationic drugs eliminated by renal tubular secretion
• Potential interaction with phenprocoumon and levothyroxine

Contraindications

• Renal disease or renal dysfunction
• Acute or chronic metabolic acidosis
• History of serious hypersensitivity reaction
• During radiologic studies involving intravascular administration of iodinated contrast materials

Side Effects

• Diarrhea
• Upper respiratory tract infection
• Headache
• Hypoglycemia
• Nasopharyngitis
• Diarrhea
• Nausea/vomiting
• Flatulence

Pregnancy & Lactation

• Pregnancy Category B
• Caution during lactation

Precautions & Warnings

• Lactic acidosis risk factors and symptoms
• Monitoring of TSH levels in patients with hypothyroidism
• Long-term treatment associated with a decrease in vitamin B12 serum levels
• Caution in patients with hepatic disease
• Assessment of renal function before and during treatment
• Postmarketing reports of acute pancreatitis

Overdose Effects

• Supportive measures for sitagliptin overdose
• Hemodialysis for removal of accumulated drug in metformin overdose
• Risk of pancreatitis in metformin overdose

Therapeutic Class

• Combination Oral hypoglycemic preparations

Storage Conditions

• Store below 25°C in a dry place away from light
• Keep out of the reach of children
• Dispensed only on the prescription of a registered physician

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