Ace 125 mg

Description

Indications
Ace is recommended for managing fever, common cold, influenza, headaches, toothaches, earaches, body aches, muscle pain (myalgia), nerve pain (neuralgia), menstrual pain (dysmenorrhea), sprains, colic pain, back pain, post-operative and postpartum pain, inflammatory pain, and post-vaccination pain in children. Additionally, it is effective in alleviating pain and joint stiffness associated with rheumatic and osteoarthritic conditions.

Use under the guidance of a registered physician.

Pharmacology
Paracetamol works by blocking pain signals at the peripheral level and reducing fever by acting on the hypothalamic heat-regulating center. Unlike NSAIDs, it does not inhibit cyclooxygenase in peripheral tissues, making it less likely to cause anti-inflammatory effects outside the central nervous system. Research suggests that Paracetamol primarily affects COX-3, a variant of the cyclooxygenase enzyme, although its precise mechanism remains under study. Its antipyretic properties stem from its influence on the hypothalamus, which promotes vasodilation and sweating, leading to heat dissipation.

Dosage & Administration
Tablets:

• Adults: 1-2 tablets every 4 to 6 hours, not exceeding 4 grams (8 tablets) per day.
• Children (6-12 years): ½ to 1 tablet, 3-4 times daily, with a maximum long-term dose of 2.6 grams per day.

Extended-Release Tablets:

• Adults & Children (12 years and older): 2 tablets every 6-8 hours, with a maximum of 6 tablets in 24 hours. Tablets must be swallowed whole and not crushed.

Syrup/Suspension:

• Infants (under 3 months): 10 mg/kg per dose (reduce to 5 mg/kg if jaundiced), 3-4 times daily.
• 3 months – 1 year: ½ – 1 teaspoon, 3-4 times daily.
• 1-5 years: 1-2 teaspoons, 3-4 times daily.
• 6-12 years: 2-4 teaspoons, 3-4 times daily.
• Adults: 4-8 teaspoons, 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): 0.5-1 gram, 4 times daily.

Paediatric Drops:

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

IV Infusion:

• Adults & Adolescents (50 kg and above): 1000 mg every 6 hours or 650 mg every 4 hours (max 4000 mg/day).
• Adults & Adolescents (under 50 kg): 15 mg/kg every 6 hours or 12.5 mg/kg every 4 hours (max 75 mg/kg/day).
• Children (2-12 years): 15 mg/kg every 6 hours or 12.5 mg/kg every 4 hours (max 75 mg/kg/day).

Interactions
Concurrent use of barbiturates, tricyclic antidepressants, or alcohol may impair Paracetamol metabolism. Alcohol consumption increases the risk of liver toxicity. Chronic use of anticonvulsants or oral contraceptives may reduce Paracetamol’s effectiveness due to increased liver enzyme activity.

Contraindications
Paracetamol is contraindicated in individuals with known hypersensitivity to the drug.

Side Effects
Most side effects are mild but may include hematological reactions such as thrombocytopenia, leucopenia, pancytopenia, neutropenia, and agranulocytosis. Other reported effects include pancreatitis, skin rashes, and occasional allergic reactions.

Pregnancy & Lactation
Epidemiological studies suggest that Paracetamol is safe when used within the recommended dosage during pregnancy. It is excreted in breast milk in minimal amounts, making it generally safe for lactating mothers. However, medical guidance should always be followed.

Precautions & Warnings
Use with caution in patients with severe renal or hepatic impairment, non-cirrhotic alcoholic liver disease, or chronic malnutrition. Overuse can result in severe hepatotoxicity. Patients should avoid taking multiple Paracetamol-containing medications simultaneously. Life-threatening anaphylactic reactions have been rarely reported.

Special Populations

• Pediatric Use: Safe and effective for children aged 2 years and older based on clinical studies.
• Geriatric Use: No significant differences in safety or effectiveness compared to younger patients.
• Hepatic Impairment: Use with caution in mild to moderate liver disease; contraindicated in severe cases.
• Renal Impairment: Dosage adjustments and extended dosing intervals may be necessary for severe kidney impairment (creatinine clearance < 30 ml/min).

Overdose Effects
Paracetamol overdose (≥10 g in adults or ≥5 g in high-risk individuals) may lead to severe liver damage. Symptoms in the first 24 hours include pallor, nausea, vomiting, anorexia, and abdominal pain, progressing to hepatic failure, encephalopathy, hemorrhage, hypoglycemia, and possibly death. Immediate medical intervention is essential, with treatment including activated charcoal (if ingestion is recent) and N-acetylcysteine as an antidote within 8 hours.

Therapeutic Class
Non-opioid analgesics.

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

Common Questions

• What is Ace 125 mg Suppository?
  Ace 125 mg Suppository helps relieve pain and fever by blocking pain-signaling chemicals.
• What conditions does it treat?
  Used for fever, post-immunization fever, and menstrual cramps.
• What are its side effects?
  Possible side effects include allergic reactions, stomach discomfort, fatigue, anemia, nausea, and vomiting.
• How should it be stored?
  Keep at room temperature, away from heat and light, and out of reach of children.
• Can it be taken on an empty stomach?
  It works best when taken with food.
• How long should I use it?
  Follow your doctor’s recommendations for the duration of use.
• Is it safe to take with antibiotics?
  Consult your doctor before combining it with any medication.
• Is Ace an NSAID?
  No, it is classified as a non-opioid analgesic.