Galvus 50 mg (Tablet)

Indications

• Adjunct to diet and exercise
• Improves glycemic control
• Type 2 diabetes mellitus treatment
• Monotherapy
• Dual combination therapy

Pharmacology

• Dipeptidyl peptidase-4 (DPP-4) inhibitor
• Slows inactivation of incretin hormones
• Incretin hormones: GLP-1 and GIP
• Physiological regulation of glucose homeostasis

Dosage & Administration

• 50 mg or 100 mg daily for monotherapy
• 50 mg twice daily in dual combination with Metformin or Thiazolidinedione
• 50 mg once daily in dual combination with a Sulphonylurea
• May be taken with or without a meal
• No dosage adjustment required in the elderly or in patients with mild renal impairment

Interaction

• No interactions with specific medications observed
• Possible reduction in glucose-lowering effect with certain active substances

Contraindications

• Hypersensitivity to the active substance or excipients
• Moderate to severe renal impairment
• Hepatic impairment: pre-treatment ALT or AST >3 times ULN
• Type 1 diabetes

Side Effects

• Majority of adverse reactions are mild and transient
• Rare cases of hepatic dysfunction
• No additional safety signals or unforeseen risks in long-term trials

Pregnancy & Lactation

• Not recommended for use during pregnancy
• Not recommended for use during lactation

Precautions & Warnings

• Caution in patients aged 75 years and older
• LFT monitoring prior to initiation and at regular intervals
• Discontinue treatment if transaminase levels are increased
• Caution in patients with congestive heart failure of NYHA functional class I-II
• Do not use in patients with NYHA functional class III-IV

Therapeutic Class

• Dipeptidyl Peptidase-4 (DPP-4) inhibitor

Storage Conditions

• Store below 30°C
• Keep away from light and moisture
• Keep out of reach of children

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