Product image of Novalgine (Metamizole Sodium Monohydrate) supplied by GNH India

Novalgine

Active Ingredient:
Metamizole Sodium Monohydrate
Origin:
EU

Novalgine (Metamizole Sodium Monohydrate)

Metamizole sodium, the active ingredient in Novalgine, is a pyrazolone presented as an injectable solution for intramuscular and intravenous administration. It provides analgesic and antipyretic effects, making it suitable for the treatment of moderate to severe pain, postoperative discomfort, fever, and colic in adult patients.

GNH India supplies Novalgine as a licensed, GMP‑certified, GDP‑compliant international pharmaceutical supplier, delivering the product to hospitals, pharmacies, and clinics worldwide through a robust distribution network that meets regulatory requirements across multiple markets and ensures timely, safe delivery.

Manufacturer / TM Owner

Opella Healthcare Belgium (Handelsnaam Sanofi Belgium)

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Indications & Clinical Uses

  • Novalgine (metamizole sodium) is employed for the management of pain and fever by inhibiting prostaglandin synthesis.
  • Pain: Provides effective analgesia for acute moderate to severe pain, including musculoskeletal injuries, postoperative discomfort, and visceral pain, improving patient mobility.
  • Fever: Reduces elevated body temperature in febrile conditions, offering rapid antipyretic action that helps prevent complications of high fever.
  • Postoperative pain: Controls pain following surgical procedures, facilitating patient comfort, early mobilization, and smoother postoperative recovery.
  • Colic: Alleviates severe abdominal cramping and discomfort associated with intestinal colic, contributing to faster symptom relief.

How It Works

  • Metamizole sodium acts as a non‑opioid analgesic by inhibiting cyclooxygenase enzymes, which reduces the synthesis of prostaglandins involved in pain and fever pathways. The drug also exerts central effects on the spinal cord and brainstem, contributing to its antipyretic and analgesic properties without significant interaction with opioid receptors. It does not significantly affect platelet aggregation, and its analgesic effect is comparable to that of other non‑steroidal anti‑inflammatory drugs, though the exact molecular binding profile remains partially characterized.

Side Effects

Novalgine may cause a range of adverse reactions, varying from mild to severe.

Common Side Effects

  • Hypotension: transient drop in blood pressure after injection.
  • Nausea: mild to moderate nausea.
  • Dizziness: feeling of light‑headedness.
  • Injection site pain: local discomfort or erythema.
  • Rash: mild skin irritation.
  • Headache: mild headache.
  • Fever: transient low‑grade fever.

Serious or Rare Side Effects

  • Agranulocytosis: severe reduction in white blood cells, potentially life‑threatening.
  • Anaphylaxis: acute allergic reaction with respiratory distress.
  • Stevens‑Johnson syndrome: severe skin and mucous membrane reaction.
  • Severe hypotension: prolonged low blood pressure requiring intervention.
  • Blood dyscrasias: abnormal blood cell counts.

Precautions & Warnings

  • When using Novalgine, clinicians should observe specific precautions to minimize risks.
  • Assess renal function: adjust use in patients with severe renal impairment.
  • Monitor blood counts: regular CBC testing to detect agranulocytosis early.
  • Avoid in known hypersensitivity: do not administer to patients allergic to pyrazolones.
  • Caution with anticoagulants: increased bleeding risk may occur.
  • Pregnancy and lactation: safety not established; avoid unless benefit outweighs risk.
  • Store at 2-8°C: keep refrigerated, protect from light, do not freeze.

Avoid Interactions

Novalgine can interact with several medicines; awareness of major and moderate interactions helps ensure safe therapy.

Major Interactions (Avoid)

  • Concurrent myelotoxic drugs: increased risk of agranulocytosis.
  • ACE inhibitors: may potentiate hypotensive effects.
  • Other NSAIDs: additive renal toxicity and gastrointestinal risk.

Moderate Interactions (Monitor Closely)

  • Anticoagulants: heightened bleeding tendency.
  • Diuretics: may enhance hypotensive response.
  • Lithium: possible increase in serum lithium levels.

Frequently Asked Questions

Novalgine contains metamizole sodium and is indicated for the relief of moderate to severe pain, reduction of fever, management of postoperative discomfort, and treatment of colic. It is used in adult patients when a rapid analgesic and antipyretic effect is required.

Metamizole sodium works by inhibiting cyclooxygenase enzymes, which lowers prostaglandin production involved in pain and fever pathways. It also has central actions on the spinal cord and brainstem that contribute to its analgesic and antipyretic effects without engaging opioid receptors.

The dosage of Novalgine is determined by the prescribing clinician based on the patient’s condition, severity of symptoms, and route of administration. Healthcare professionals adjust the dose according to clinical guidelines and individual patient factors.

Safety data for metamizole sodium in pregnancy and lactation are limited. The product is generally avoided unless the potential benefit justifies the potential risk to the fetus or infant. Consultation with a healthcare provider is essential before use in these populations.

To order Novalgine, 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 (including cold‑chain if needed) and import documentation.

Novalgine offers a non‑opioid alternative with both analgesic and antipyretic activity, similar to NSAIDs but with a distinct pyrazolone structure. Compared with traditional NSAIDs, it may have a lower risk of gastrointestinal irritation but carries a rare risk of severe blood‑cell disorders, requiring careful monitoring.

Novalgine should be stored at 2‑8 °C in a refrigerator, protected from light, and must not be frozen or shaken. The vial should remain in its original packaging until use to maintain stability and sterility.

Novalgine is supplied as a sterile injectable solution and can be given either intramuscularly or intravenously by a qualified healthcare professional. The route, volume, and rate of administration are determined by the prescriber according to the clinical situation.

The most serious risks include agranulocytosis, a potentially life‑threatening drop in white‑blood‑cell count, and severe allergic reactions such as anaphylaxis or Stevens‑Johnson syndrome. Prompt recognition and immediate medical intervention are critical if these reactions occur.

Novalgine should be avoided in patients with known hypersensitivity to metamizole or other pyrazolones, in individuals with severe renal impairment without dose adjustment, and in pregnant or breastfeeding women unless the benefit outweighs the risk. It is also contraindicated in patients with a history of severe blood‑cell disorders.

Published by

GNH India Pharmaceuticals Limited

Licensed pharmaceutical supplier

Last updated:

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