Ace 500 mg

Description

Indications:

Ace is prescribed for managing fever, common cold, influenza, and various types of pain, including headaches, toothaches, earaches, body aches, myalgia, neuralgia, dysmenorrhea, colic pain, back pain, post-operative and postpartum pain, inflammatory discomfort, and post-vaccination pain in children. It is also effective in alleviating rheumatic and osteoarthritic pain, as well as joint stiffness.

Use only as directed by a registered physician.

Pharmacology:

Paracetamol works by inhibiting pain impulses in the peripheral nervous system and reducing fever through its action on the hypothalamic heat-regulating center. Unlike NSAIDs, it does not significantly impact inflammation in peripheral tissues. Its primary mechanism involves blocking cyclooxygenase enzymes (COX-1, COX-2, and COX-3) in the central nervous system, increasing the pain threshold. Studies suggest that Paracetamol may selectively inhibit COX-3, but its exact mode of action is still under research.

Dosage & Administration:

Tablets:

• Adults: 1-2 tablets every 4-6 hours (maximum 8 tablets or 4g per day).
• Children (6-12 years): ½ to 1 tablet, 3-4 times daily. For long-term use, the daily dose should not exceed 2.6g.

Extended Release Tablets:

• Adults & Children (12+ years): 2 tablets every 6-8 hours (maximum 6 tablets per day). Do not crush the tablets.

Syrup/Suspension:

• Children under 3 months: 10 mg/kg body weight (reduce to 5 mg/kg in jaundiced infants), 3-4 times daily.
• 3 months to below 1 year: ½ to 1 teaspoonful, 3-4 times daily.
• 1-5 years: 1-2 teaspoonfuls, 3-4 times daily.
• 6-12 years: 2-4 teaspoonfuls, 3-4 times daily.
• Adults: 4-8 teaspoonfuls, 3-4 times daily.

Suppository:

• 3-12 months: 60-120 mg, 4 times daily.
• 1-5 years: 125-250 mg, 4 times daily.
• 6-12 years: 250-500 mg, 4 times daily.
• Adults & children (12+ years): 0.5-1g, 4 times daily.

Paediatric Drops:

• Up to 3 months: 0.5 ml (40 mg).
• 4 to 11 months: 1.0 ml (80 mg).
• 1-2 years: 1.5 ml (120 mg).Do not exceed 5 doses per day for a maximum of 5 days.

Tablets with Actizorb Technology:

• Adults & children (12+ years): 1-2 tablets every 4-6 hours (maximum 8 caplets in 24 hours).
• Children (7-11 years): ½-1 tablet every 4-6 hours (maximum 4 caplets in 24 hours). Not recommended for children under 7 years.

IV Infusion:

• Adults & adolescents (50kg+): 1000 mg every 6 hours or 650 mg every 4 hours (maximum daily dose: 4000 mg).
• Adults & adolescents (below 50kg): 15 mg/kg every 6 hours or 12.5 mg/kg every 4 hours (maximum 75 mg/kg per day).
• Children (2-12 years): 15 mg/kg every 6 hours or 12.5 mg/kg every 4 hours (maximum 75 mg/kg per day).

Use only as prescribed by a physician.

Drug Interactions:

Patients using barbiturates, tricyclic antidepressants, or alcohol may have reduced ability to metabolize high doses of Ace. Alcohol may increase the risk of liver toxicity. Chronic use of anticonvulsants or steroid contraceptives may alter Ace’s effectiveness by affecting liver metabolism.

Contraindications:

Ace should not be used by individuals with known hypersensitivity to Paracetamol.

Side Effects:

Side effects are generally mild but may include hematological disorders such as thrombocytopenia, leukopenia, pancytopenia, neutropenia, and agranulocytosis. Allergic reactions, including skin rashes and pancreatitis, have been reported in rare cases.

Use During Pregnancy & Lactation:

Studies have shown no significant adverse effects when used in recommended doses during pregnancy. Paracetamol is excreted in breast milk in minimal amounts, which is not clinically significant. However, patients should consult their doctor before use.

Precautions & Warnings:

• Use cautiously in patients with severe liver or kidney impairment.
• Overdose risks are higher in individuals with non-cirrhotic alcoholic liver disease.
• Do not exceed the recommended dose.
• Patients should avoid taking multiple Paracetamol-containing products simultaneously.
• Higher-than-recommended doses may cause severe liver damage, including hepatotoxicity and, in rare cases, fatality.
• Infrequent cases of severe allergic reactions (anaphylaxis) requiring emergency medical attention have been reported. If symptoms of hypersensitivity occur, discontinue use immediately.

Special Population Considerations:

• Pediatric Use: Approved for treating pain and fever in children aged 2 years and older.
• Geriatric Use: No significant differences in safety or effectiveness observed between elderly and younger patients.
• Hepatic Impairment: Not recommended for patients with severe liver disease; use cautiously in those with mild to moderate hepatic conditions.
• Renal Impairment: Patients with severe renal dysfunction (creatinine clearance <30 ml/min) may require longer dosing intervals and lower daily doses.

Overdose & Management:

Liver damage is a concern in adults consuming over 10g of Ace. Doses above 5g may cause toxicity in individuals with risk factors such as chronic alcohol use, enzyme-inducing drugs, or glutathione depletion (e.g., malnourishment, certain infections).

Symptoms of Overdose:

• Initial symptoms (first 24 hours): nausea, vomiting, anorexia, abdominal pain, and pallor.
• After 12-48 hours: potential liver damage, metabolic acidosis, and glucose metabolism disorders.
• Severe cases: hepatic failure, encephalopathy, internal bleeding, cerebral edema, renal failure, and potential fatality.

Treatment:

• Activated charcoal may be administered within one hour of overdose.
• Plasma Paracetamol levels should be checked after 4 hours.
• N-acetylcysteine is the preferred antidote within 24 hours (most effective within 8 hours).
• In severe cases, methionine may be an alternative in resource-limited areas.

Therapeutic Class:

Non-opioid analgesics.

Storage Conditions:

Store in a cool, dry place, away from direct light and heat. Keep out of reach of children.

Chemical Formula: C₈H₉NO₂