Ibuprofen 300 mg + Paracetamol 1000 mg Injection

Trade Name:
Generic Name: Ibuprofen + Paracetamol

Dosage Form and Packaging

This medicine is available as an intravenous (IV) injection solution.
Each vial/ampoule (100 mL) contains:

• Ibuprofen sodium equivalent to 300 mg of ibuprofen
• Paracetamol (acetaminophen) 1000 mg

Pharmacological Class:
Non-steroidal anti-inflammatory drug (NSAID) + Non-opioid analgesic

Indications

• Moderate to severe acute pain, especially post-operative pain
• Acute musculoskeletal pain
• Severe headache or acute migraine
• High fever in hospitalized patients unable to take oral medication

Dosage and Administration

Typical adult dose:
One vial (300 mg ibuprofen + 1000 mg paracetamol) every 6 to 8 hours as needed.

Maximum daily dose:

• Ibuprofen: up to 2400 mg
• Paracetamol: up to 4000 mg

Method of administration:
Administer by slow intravenous infusion over 15 to 30 minutes.
Use only in a hospital setting by trained healthcare professionals.

Contraindications

• Hypersensitivity to any component of the formulation
• Severe hepatic impairment or active liver disease (related to paracetamol)
• History of gastrointestinal bleeding associated with NSAIDs
• Severe renal impairment
• Concurrent use with other medications containing paracetamol or NSAIDs

Precautions

• Use with a lower dose and regular monitoring in patients with hepatic or renal impairment
• Risk of gastrointestinal bleeding due to ibuprofen
• Prolonged or high-dose use may cause liver or kidney failure
• Use cautiously in elderly patients

Drug Interactions

• Alcohol: Increases risk of paracetamol-induced hepatotoxicity
• Warfarin: Enhances anticoagulant effect
• Lithium: Increases serum lithium concentration (due to ibuprofen)
• Methotrexate: Increases methotrexate toxicity
• Antihypertensive drugs: NSAIDs may reduce their effectiveness

Adverse Reactions

Common side effects:

• Nausea, vomiting
• Dizziness, drowsiness
• Gastrointestinal disturbances
• Elevated liver enzymes
• Pain at injection site

Rare but serious side effects:

• Acute liver injury (paracetamol)
• Gastrointestinal bleeding (ibuprofen)
• Severe allergic reactions (anaphylaxis)
• Renal failure
• Increased blood pressure

Storage Conditions

• Store at 15–30°C
• Protect from direct light
• Do not freeze
• Keep out of reach of children

Dispensing Conditions

For prescription use only

Manufacturer Information:
Manufacturer: Parsawa Injectable Solutions Manufacturing Factory
Address: Afghanistan, Herat, Industrial Park, Phase 3, Sosan 5