Category: Tablets
Classification:Analgesics
Product English Name: Hi-Mol
Product Arabic Name:هاي-مول
Scientific Name English: Paracetamol
Scientific Name Arabic: باراسيتامول
Product Unit: 20 Tablets
Product Strength:500mg
Pharmacodynamics and Mechanism of Action:
Paracetamol is an effective analgesic and antipyretic agent. Its mechanism of action involves central activity on the hypothalamic heat-regulating center to reduce fever and inhibition of prostaglandin synthesis in the central nervous system to alleviate pain.
| Pharmacokinetics | Absorption: |
|---|---|
| Before You Start Hi-Mol | Tell your doctor if you: |
| Indications and Usage | • Relief of mild to moderate pain (e.g., headache, toothache, muscle pain, osteoarthritis, and menstrual pain). |
| Administration and Dosage: | Adults and children ≥ 12 years: 1- 2 tablets or sachets every 4 to 6 hours as needed. Maximum: 4 g or 8 tablets or 8 sachets per day. Children (6 – 11 years): 1/2 – 1 tablet every 4 to 6 hours, or 1 sachet every 6 hours as needed. Total daily dose should not exceed 4 tablets or 4 sachets within 24 hours. |
| Administration Guide: | • For oral administration only, can be taken with or without food. • Do not exceed the stated dose. – For Hi-Mol tablets: Should be swallowed with a glass of water. – For Hi-Mol sachets: Empty the contents of one sachet into half a glass of water. Dissolve well before drinking. |
| Contraindications: | • Hypersensitivity to Paracetamol or any component of the formulation. • Severe hepatic impairment or active liver disease. |
| Warnings and Precautions: | Hepatic Toxicity: Excessive use may lead to liver failure. Avoid exceeding the maximum daily dose. Alcohol Consumption: Increased risk of hepatotoxicity with chronic alcohol consumption. |
| Patients with renal impairment: | In case of creatinine clearance < 10 mL/min, the elimination of paracetamol and its metabolites is delayed. The minimum interval between each administration is 6 to 8 hours when paracetamol is administered. |
| Patients with hepatic impairment: | Administration of paracetamol at doses higher than recommended may result in hepatic injury, including the risk of liver failure. Do not exceed the maximum recommended daily dose of paracetamol. Use caution when administering paracetamol in patients with the following conditions: hepatic impairment or active hepatic disease, alcoholism, chronic malnutrition, severe hypovolemia. |
| Pregnancy: | A large amount of data on pregnant women indicates no increased risk of malformations nor fetal/neonatal toxicity. |
| Lactation: | Paracetamol is eliminated in breast milk and has been detected in concentration with a 1:1 ratio with those in plasma. However, paracetamol is considered compatible with breast-feeding. |
| Pediatric Use: | The safety and effectiveness of paracetamol for the treatment of acute pain and fever in pediatric patients ages 2 years and older is supported by evidence from adequate and well controlled studies of paracetamol in adults. |
| Side Effects/ Adverse Reactions: | Paracetamol is well tolerated when taken in recommended doses. Some allergic reactions like skin rash may rarely occur. |
| Drug Interactions: | CYP450 Enzyme Inducers (e.g., Rifampin (Rifampicin), Carbamazepine): May increase risk of hepatotoxicity. Alcohol: Chronic use may increase the likelihood of liver damage. Warfarin: Prolonged use may enhance anticoagulant effects; monitor INR. |
| Overdosage: | Paracetamol overdose occurs when large amounts (typically more than 150 mg/kg or 10 g in 24 hours) are taken, which can lead to serious liver damage. Early symptoms may be mild, such as nausea or vomiting, but liver injury can develop within 24–72 hours. Blood tests are used to measure paracetamol levels and assess the risk. The main treatment is N-acetylcysteine (NAC), which is most effective if given within 8 hours, but can still be helpful later. Anyone who may have taken too much paracetamol should seek medical attention immediately, even if no symptoms are present. |
| Storage Conditions: | Store in a dry place below 30°C. |
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