(Paracetamol) 

Infusion for IV. Use Only

Infusion 1000mg/100ml

Composition

Each 100 ml contains:

Paracetamol ................. 1000 mg

Product Description 

Paracetamol IV Infusion is a clear, sterile solution containing Paracetamol 1000mg/100ml. It is used for the short-term treatment of moderate pain and fever.

Indications 

- Management of mild to moderate pain. 

- Reduction of fever when oral administration is not possible or contraindicated. 

- Suitable for postoperative pain, headache, musculoskeletal pain, and febrile conditions.

Dosage and Administration 

- For intravenous use only. 

  - Infuse over 15 minutes. 

Dosage 

Adjusted based on patient weight, liver, and kidney function. - Adults and children >33kg: 100ml (1000mg) per dose. 

  - Children ≤33kg: Dose calculated as 15mg/kg (1.5ml/kg).

- Maximum Daily Dose: 

  - Adults without hepatotoxicity risk factors: 4g/day. 

  - Adults with hepatotoxicity risk factors: 3g/day. 

  - Children: 60mg/kg/day, not exceeding 2-3g based on weight. 

- Interval: At least 4 hours between doses (6 hours for severe renal impairment). 

Contraindications

- Hypersensitivity to paracetamol or any excipients. 

- Severe hepatic impairment or active liver disease. 

Precautions

- Hepatic Insufficiency: Paracetamol should be used with caution in patients with hepatic insufficiency.

- Severe Renal Insufficiency: In patients with creatinine clearance ≤ 30 mL/min, the interval between doses should be increased to 6 hours.

- Chronic Alcoholism and Malnutrition: These conditions may reduce hepatic glutathione reserves.

- Pregnancy: Paracetamol should only be used during pregnancy after a careful benefit-risk assessment.

- Lactation: Paracetamol is excreted in breast milk in small amounts, and no adverse effects on nursing infants have been reported. 

Drug Interactions

- Probenecid: Reduces the clearance of paracetamol, and a dose reduction of paracetamol may be necessary.

- Salicylamide: May prolong the elimination half-life of paracetamol.

- Enzyme-Inducing Substances: Caution is advised when used concomitantly.

- Oral Anticoagulants: Concurrent use with high doses (4 g/day for at least 4 days) may lead to slight variations in INR values. Close monitoring of INR is recommended.

Side Effects

Common side effects may include: -

Nausea, vomiting, Malaise(general), Hypersensitivity reactions (e.g., rash, itching), Injection site reactions (e.g., pain, redness)

Rare but serious side effects: -

Hepatotoxicity, thrombocytopenia, or agranulocytosis

Storage 

Store below 30°C, Protect from light-

- Do not refrigerate or freeze, Keep out of reach of children.   

Manufacturer Information 

-Name of Company: Parsawa parenteral fluids manufacturing factory      

Add: Afghanistan, Herat, Industrial Town, Phase3, Susan5