Registered Kenya · PPB

LIPAGLYN

SAROGLITAZAR MAGNESIUM

H2018/6145/754ER 4MG PER TABLET NEW/INNOVATOR

What it does

Saroglitazar is a medication used to help manage certain blood sugar levels in people with diabetes.

Commonly used for: diabetes (both type 2 diabetes and hyperglycemia)

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Plain-language summary for general understanding - not medical advice. Always follow your pharmacist/doctor.

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Registration & product details

Registration no.
H2018/6145/754ER
Registration date
2019-02-21 00:00:00
Expiry date
-
Status
Registered
Active ingredient
SAROGLITAZAR MAGNESIUM
Dosage form
4MG PER TABLET
Strength
-
Pack size
ALU-ALU BLISTER PACK OF 10 TABLETS (10X1X10 TABLETS)
Therapeutic class
NEW/INNOVATOR
Manufacturer / MAH
Zydus Lifesciences
Applicant / LTR
CADILA HEALTHCARE LIMITED
Country of origin
FOREIGN
Manufacturer location
Sarkhej-Bavla Rd, Sarkhej, Ahmedabad, Changodar, Gujarat 382213, India

Source: Pharmacy and Poisons Board · fetched 2026-01-28 20:00:35 · updated 2026-08-03 03:09:56

Disclaimer: This information is sourced from Pharmacy and Poisons Board (Kenya). Always consult a qualified healthcare professional before using any medication.

About this medicine

Saroglitazar is a medication used to help manage certain blood sugar levels in people with diabetes.

What it treats

  • diabetes (both type 2 diabetes and hyperglycemia)

How it works

Saroglitazar helps improve how the body uses sugar and reduces fat levels in the blood.

Who it's for

This medicine is for adults with diabetes who need help controlling their blood sugar.

AI-assisted summary grounded in BNF data - general information only, not medical advice. Always confirm with your pharmacist or doctor.

Clinical monograph: saroglitazar

BNF-referenced

Saroglitazar is a dual PPAR agonist, primarily targeting peroxisome proliferator-activated receptors (PPAR) alpha and gamma. It is indicated for the treatment of diabetic dyslipidemia and associated conditions, particularly in patients with type 2 diabetes mellitus. By modulating lipid metabolism and improving insulin sensitivity, saroglitazar helps in managing dyslipidemia and reducing cardiovascular risks related to diabetes.

Indications

  • Diabetic dyslipidemia
  • Type 2 diabetes mellitus

Dosage

Children: Refer to the BNF for Children for appropriate dosing information.

Adults: Refer to the BNF for specific dosing recommendations.

Mechanism of action

Saroglitazar works by activating both PPAR-alpha and PPAR-gamma pathways. Activation of PPAR-alpha leads to increased fatty acid oxidation, decreased triglyceride levels, and improved lipid profiles. PPAR-gamma activation enhances insulin sensitivity, promoting glucose uptake and lowering blood glucose levels. This dual action helps in addressing the metabolic abnormalities in patients with diabetes.

Pharmacodynamics

The pharmacodynamic effects of saroglitazar include significant reductions in triglycerides and total cholesterol, alongside improvements in high-density lipoprotein (HDL) cholesterol levels. Its dual action on PPAR receptors also plays a role in reducing insulin resistance, thereby aiding in better glycemic control in diabetic patients.

Pharmacokinetics

Saroglitazar is absorbed following oral administration, with peak plasma concentrations typically occurring within 2 to 4 hours. It has a high bioavailability due to extensive hepatic metabolism, primarily via cytochrome P450 enzymes. The drug has a long half-life, allowing for once-daily dosing. Elimination occurs through both hepatic and renal routes, with metabolites primarily excreted in urine.

Contra-indications

  • Hypersensitivity to saroglitazar or any of its components
  • Severe liver impairment
  • Severe renal impairment
  • Pregnancy

Adverse effects

  • Nausea
  • Diarrhea
  • Abdominal pain
  • Headache
  • Dizziness
  • Fatigue
  • Liver enzyme elevation

Interactions

  • Caution with other antidiabetic medications
  • Potential interaction with drugs metabolized by CYP enzymes
  • Avoid concomitant use with strong CYP3A4 inhibitors

Precautions

  • Monitor liver function tests before and during treatment
  • Caution in patients with a history of liver disease
  • Assess renal function before initiation

Pregnancy

Saroglitazar is contraindicated in pregnancy due to potential risks to the fetus.

Breast-feeding

It is unknown if saroglitazar is excreted in human milk, caution is advised.

Storage

Store at room temperature, away from moisture and light.

Formulations

  • Capsules
PubChem / pathway

AI-synthesized from BNF references - general information only, not a substitute for professional medical advice or the current BNF. Verify doses with a pharmacist.

Molecular reference: saroglitazar

PubChem CID 60151560

Molecular formula: C25H29NO4S

Source: PubChem (NCBI) · pathways from PathBank, Reactome, WikiPathways & PharmGKB.