Product image of Komboglyze (Metformin Hydrochloride, Saxagliptin) supplied by GNH India

Komboglyze

Active Ingredient:
Metformin Hydrochloride, Saxagliptin
Origin:
EU

Komboglyze (Metformin Hydrochloride, Saxagliptin)

Metformin Hydrochloride, the active ingredient in Komboglyze, is a biguanide and DPP‑4 inhibitor presented as a tablet for oral use. It is indicated for the management of type 2 diabetes mellitus in adult patients, helping to control elevated blood glucose levels.

GNH India supplies Komboglyze as a licensed, GDP‑compliant international pharmaceutical supplier serving hospitals, pharmacies and clinics worldwide, with established quality assurance processes and regulatory compliance across EU and global markets, and delivering reliable product availability to meet the therapeutic needs of patients worldwide.

Manufacturer / TM Owner

Astrazeneca Ab

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Indications & Clinical Uses

Komboglyze, a fixed‑dose oral antidiabetic medication, is employed to achieve better glycemic control in the management of type 2 diabetes mellitus.

  • Type 2 diabetes mellitus: lowers fasting and post‑prandial glucose levels, helping patients reach individualized HbA1c targets when combined with diet and exercise.
  • Metformin intolerance or contraindication: offers DPP‑4 inhibition to maintain glucose regulation for patients who cannot use metformin at therapeutic doses.
  • Inadequate response to monotherapy: added to existing treatment regimens to further reduce blood glucose when a single agent fails to achieve desired control.

How It Works

  • Metformin Hydrochloride reduces hepatic gluconeogenesis and enhances peripheral insulin sensitivity, thereby decreasing glucose production and increasing glucose uptake. Saxagliptin selectively inhibits the enzyme dipeptidyl peptidase‑4 (DPP‑4), which prolongs the activity of endogenous incretin hormones (GLP‑1 and GIP). The combined effect results in glucose‑dependent insulin secretion, reduced glucagon release, and overall improvement of post‑prandial and fasting blood glucose levels.

Side Effects

Komboglyze may be associated with a range of adverse reactions, varying from mild to serious.

Common Side Effects

  • Nausea: mild to moderate stomach upset, often transient.
  • Diarrhea: loose stools, usually transient and may cause dehydration if severe.
  • Headache: mild cranial discomfort and may be aggravated by stress.
  • Upper respiratory tract infection: symptoms such as sore throat or runny nose.
  • Abdominal discomfort: mild pain or cramping in the stomach area.
  • Decreased appetite: reduced desire to eat, may lead to weight loss.

Serious or Rare Side Effects

  • Lactic acidosis: rare but potentially life‑threatening metabolic condition.
  • Pancreatitis: inflammation of the pancreas presenting with abdominal pain.
  • Severe hypersensitivity: rash, angioedema, or anaphylactic reactions.
  • Hepatic impairment: elevated liver enzymes or liver injury.

Precautions & Warnings

When prescribing Komboglyze, clinicians should consider several precautionary measures to ensure safe use.

  • Renal function: assess creatinine clearance before initiation and periodically thereafter.
  • Lactic acidosis risk: avoid in patients with severe hepatic impairment or conditions predisposing to hypoxia.
  • Hypoglycemia monitoring: caution when combined with insulin or sulfonylureas.
  • Pregnancy and lactation: use only if potential benefit justifies potential risk; consult obstetric specialist.
  • Drug interactions: review concomitant medications for major DPP‑4 inhibitor or metformin interactions.
  • Store at ambient temperature: keep below 25°C, retain original packaging, protect from moisture.

Avoid Interactions

Komboglyze can interact with other medicines, altering its efficacy or safety profile.

Major Interactions (Avoid)

  • Iodinated contrast agents: may precipitate acute renal failure when combined with metformin; discontinue metformin before and after imaging.
  • CYP3A4 strong inhibitors (e.g., ketoconazole, clarithromycin): increase saxagliptin exposure, raising risk of hypoglycemia.

Moderate Interactions (Monitor Closely)

  • Diuretics: may enhance metformin-associated lactic acidosis risk; monitor renal function.
  • Beta‑blockers: can mask hypoglycemia symptoms; observe blood glucose closely.
  • Alcohol: potentiates metformin's effect on lactate metabolism; advise limited intake.

Frequently Asked Questions

Komboglyze is an oral fixed‑dose combination of metformin hydrochloride and saxagliptin used to improve glycemic control in adults with type 2 diabetes mellitus, typically when diet, exercise, and monotherapy have not achieved target blood glucose levels.

Metformin Hydrochloride primarily reduces hepatic glucose production and enhances peripheral insulin sensitivity, which lowers fasting glucose. It also improves glucose uptake in muscle tissue, contributing to overall better blood‑sugar regulation.

The dosage of Komboglyze is individualized and set by the prescribing healthcare professional based on the patient’s clinical condition, renal function, and response to therapy. Patients should follow the prescriber’s instructions and not alter the dose without medical advice.

Safety of Komboglyze during pregnancy or lactation has not been fully established. It should only be used if the potential benefit justifies any possible risk to the fetus or infant, and the decision should be made in consultation with a qualified obstetric or pediatric specialist.

To order Komboglyze, submit an enquiry on the product page at gnhindia.com specifying the required quantity. GNH India supplies hospitals, pharmacies and procurement teams worldwide, verifies trade or institutional credentials, and then provides pricing, availability, shipping details and any necessary import documentation.

Komboglyze combines a biguanide (metformin) with a DPP‑4 inhibitor (saxagliptin), offering complementary mechanisms that can provide better glycemic control than either agent alone. Compared with sulfonylureas, it has a lower risk of hypoglycemia, and unlike insulin, it is administered orally.

Komboglyze tablets should be stored at ambient temperature, below 25 °C, in their original container, protected from moisture and direct sunlight. Do not store in the bathroom or near heat sources to maintain product stability.

Komboglyze is taken orally, usually with meals to reduce gastrointestinal discomfort. The tablet should be swallowed whole with a full glass of water and not crushed, chewed, or split unless specifically instructed by a healthcare professional.

Serious risks include lactic acidosis, especially in patients with renal or hepatic impairment, and pancreatitis. Signs such as unexplained muscle pain, rapid breathing, severe abdominal pain, or persistent nausea should prompt immediate medical evaluation.

Komboglyze is contraindicated in patients with known hypersensitivity to metformin, saxagliptin, or any excipients, as well as in individuals with severe renal impairment (eGFR < 30 mL/min/1.73 m²), acute or chronic metabolic acidosis, and certain hepatic conditions. Clinicians should assess each patient before initiating therapy.

Published by

GNH India Pharmaceuticals Limited

Licensed pharmaceutical supplier

Last updated:

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