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Metamizole Sodium Injection 2ml: 500mg
Composition:
Each 2ml ampoule contains:
- Metamizole Sodium .........… 500mg
- Excipients: Water for Injection
Description:
Metamizole Sodium, also known as Dipyrone, is a non-opioid analgesic and antipyretic with spasmolytic properties. It is commonly used for pain relief, fever reduction, and smooth muscle spasms.
Indications:
Metamizole Sodium Injection is indicated for the treatment of:
- Moderate to severe pain, including post-operative pain, trauma, and colic
- High fever unresponsive to other antipyretics
- Pain associated with spasms of the gastrointestinal, biliary, or urinary tract
Dosage & Administration:
Adults and Adolescents (≥15 years, ≥53 kg):
- Single dose: 500mg - 1000mg (1-2 ampoules)
- Maximum daily dose: 5000mg (10 ampoules)
- Administration: Slow intravenous (IV) injection over 5 minutes or deep intramuscular (IM) injection
Children and Adolescents:
- Dosage based on body weight: 6-16 mg/kg per dose
- Administered as IV infusion or IM injection under medical supervision
Administration Guidelines:
- IV injection: Must be given slowly (over ≥5 minutes) to prevent hypotension
- IM injection: Deep intramuscular administration is recommended
- Dilution: If required, dilute with 0.9% Sodium Chloride or 5% Dextrose Injection
Contraindications:
- Hypersensitivity to Metamizole or other pyrazolone derivatives
- Bone marrow suppression or pre-existing blood disorders (e.g., agranulocytosis)
- Severe hepatic or renal impairment
- Pregnancy (especially third trimester) and lactation
- Glucose-6-phosphate dehydrogenase (G6PD) deficiency
Warnings & Precautions:
- Risk of agranulocytosis (monitor for signs of infection)
- Hypotension risk (especially with IV use)
- Caution in patients with asthma or NSAID hypersensitivity
- Avoid prolonged use to reduce the risk of blood dyscrasias
Adverse Reactions:
- Common: Hypotension, dizziness, nausea
- Serious: Agranulocytosis, anaphylactic shock, leukopenia, severe skin reactions (e.g., Stevens-Johnson syndrome)
Drug Interactions:
- Cyclosporine: May reduce cyclosporine levels
- NSAIDs & anticoagulants: Increased risk of bleeding
- CYP2B6 and CYP3A4 inhibitors/inducers: May affect metabolism
Overdose & Management:
- Symptoms: Nausea, vomiting, abdominal pain, renal impairment, convulsions
- Treatment: Supportive care, IV fluids, activated charcoal if ingested
Storage Conditions:
- Store below 25°C
- Protect from light
- Use immediately after opening



