Generic
Saroglitazar Magnesium
2 brands available in the market
At a glance
Saroglitazar Magnesium is used for the treatment of diabetic dyslipidemia and hypertriglyceridemia, particularly in type 2 diabetes patients not controlled by statin therapy. It is a PPAR-α agonist that reduces triglycerides and LDL cholesterol.
Description
Saroglitazar is a potent and predominantly PPAR-α agonist with moderate PPAR-γ agonistic activity. PPARs are nuclear lipid-activated transcription factors that regulate lipid metabolism, glucose homeostasis, and inflammatory processes. Saroglitazar activates PPARα to increase hepatic fatty acid oxidation and reduce TG synthesis; PPARγ activation improves insulin sensitivity.
Indications
- Diabetic dyslipidemia
- Hypertriglyceridemia (with type 2 diabetes, uncontrolled by statins)
Therapeutic class
Hypolipidemic & Antidiabetic
Pharmacological class
PPAR-α/γ Agonist
Pharmacology
Saroglitazar activates PPARα to increase hepatic fatty acid oxidation, reduce TG synthesis and secretion, activate LPL to eliminate TG-rich particles, and lower LDL cholesterol. PPARγ activation regulates insulin-responsive genes involved in glucose production, transport, and utilization, improving post-absorptive glucose suppression.
Mechanism of action
Activates PPAR-α to reduce triglycerides and LDL cholesterol, and PPAR-γ to improve insulin sensitivity.
Dosage
Adult Dose (Oral):
- Recommended dose: Two tablets of 2 mg once daily (total 4 mg/day)
Administration
- Take orally with or without food
- Take at the same time each day
- Take as directed by a physician
Missed dose
If you miss a dose, take it as soon as you remember; if almost time for the next dose, skip it; do not double the dose.
Side effects
Common Side Effects (>2%):
- Gastritis
- Asthenia (weakness)
- Pyrexia (fever)
Precautions & warnings
- Caution in abnormal liver or renal function
- Caution in history of myopathies
- Caution in patients with cardiac disease and congestive heart failure
- Assess for fluid accumulation if rapid weight gain occurs
Contraindications
- Hypersensitivity to saroglitazar or any excipient
Drug interactions
- No significant interactions with CYP1A2, 2C9, 2C19, 2D6, and 3A4
- No potential for CYP3A4 enzyme induction
Food interactions
Caution is advised when consuming alcohol with Saroglitazar; consult your doctor.
Use in pregnancy
Use in Pregnancy: Safety not established in pregnancy; use only if clearly needed; consult your doctor.
Pregnancy Category: C — always consult a doctor before taking during pregnancy.
Use in lactation
Use in Lactation: Unknown if excreted in human milk; nursing mothers should not use; consult your doctor.
Pediatric use
Safety and effectiveness not established in children <18 years
Geriatric use
Use with caution in elderly patients considering comorbidity and concomitant medications
Renal / hepatic impairment
Renal Impairment: Caution required in abnormal renal function; consult your doctor.
Hepatic Impairment: Caution required in abnormal liver function; consult your doctor.
Overdose effects
No overdose cases reported; in case of overdose, provide general supportive care and monitor vital signs.
Storage conditions
Store below 25°C in a dry place, away from light and moisture; keep out of reach of children.
Chemical structure
Saroglitazar Magnesium