ACETAMINOPHEN 125MG PAED. SUPP.U.S.P.XXIII

Important Disclaimer: This summary is for educational and informational purposes only and should not, under any circumstances, replace direct consultation with a qualified physician or pharmacist. Always refer to the product’s internal leaflet or consult a healthcare professional before use.

Drug Name: ACETAMINOPHEN 125MG PAED. SUPP.U.S.P.XXIII

Manufacturer:

ACETAMINOPHEN 125MG PAED. SUPP.U.S.P.XXIII is manufactured by SEDICO Pharmaceutical Co., Egypt – a well-established pharmaceutical company known for producing a wide range of medications, including paediatric formulations. [1, 2]

Introduction:

Acetaminophen 125 mg paediatric suppositories are rectal formulations designed for fever and mild-to-moderate pain relief in infants and young children. This dosage form is particularly useful when oral administration is difficult (e.g., in vomiting or uncooperative children). Acetaminophen (also known as paracetamol) is a well-established analgesic and antipyretic. The "U.S.P.XXIII" indicates that the product conforms to the standards set in the United States Pharmacopeia, 23rd edition, ensuring quality and purity. [3, 4]

Indications and Usage:

Acetaminophen 125mg Paediatric Suppositories are indicated for the relief of: [3, 4, 5]

• Fever reduction in infants and children, associated with colds, flu, infections, or post-vaccination.
• Pain relief from teething, headaches, muscle aches, earache, sore throat, or discomfort following minor injuries or procedures.
• Alternative to oral forms in children with nausea, vomiting, or poor compliance.

Characteristics:

Acetaminophen (Paracetamol) is a non-opioid analgesic and antipyretic. Its mechanism of action is primarily central, involving the inhibition of prostaglandin synthesis in the central nervous system, which helps to reduce pain perception and lower body temperature. Unlike NSAIDs, it has minimal anti-inflammatory effects and does not typically cause gastric irritation or affect platelet aggregation at therapeutic doses. The suppository form allows for systemic absorption through the rectal mucosa. [3, 4, 6]

• Active Ingredient: Acetaminophen (Paracetamol) 125 mg.
• Form: Paediatric Suppository.
• Route of Administration: Rectal.
• Drug Class: Analgesic, Antipyretic.
• Mechanism of Action: Inhibits prostaglandin synthesis in the CNS and acts on the hypothalamic heat-regulating center to reduce fever. Has minimal anti-inflammatory action. [3, 4]

Dosage and Administration:

The dosage of Acetaminophen suppositories is based on the child's weight and age. Always consult a healthcare professional for precise dosing instructions. [3, 4, 5]

• General Dosing Guideline (for 125 mg suppositories):
  • Children aged 1–5 years (10–20 kg): One 125 mg suppository every 4 to 6 hours as needed.
  • Maximum Dose: Do not exceed 4 doses per 24 hours unless directed by a doctor. The total daily dose should not exceed 60 mg/kg of body weight.
• Administration Tips:
  • Wash hands thoroughly before and after use.
  • Remove the suppository from its wrapper.
  • If the suppository is too soft, chill it in the refrigerator for 30 minutes or run cold water over it before removing the wrapper.
  • Position the child on their side with the lower leg straightened and the upper leg bent forward toward the stomach.
  • Gently insert the suppository, pointed end first, into the rectum. Push it in about 1 inch (2.5 cm) for infants and young children.
  • Hold the buttocks together for a few minutes to help the suppository stay in place.
  • The suppository will melt quickly.
  • Avoid cutting or splitting suppositories.

Contraindications:

Acetaminophen 125mg Paediatric Suppositories are contraindicated in: [3, 4, 5]

• Hypersensitivity to acetaminophen or any component of the suppository.
• Severe hepatic impairment or severe liver disease.
• Known rectal irritation or bleeding, or recent rectal surgery.

Warnings and Precautions:

• Overdose Risk: Acetaminophen overdose can cause severe and potentially fatal liver damage (hepatotoxicity). Do not exceed the recommended dose or frequency. Caution is advised in children with pre-existing liver conditions or chronic malnutrition. [3, 4]
• Concomitant Use: Be aware of other medications (oral, rectal, or intravenous) that may contain acetaminophen to avoid accidental overdose. [3, 4]
• Duration: Do not use for more than 3 days for fever or 5 days for pain unless advised by a doctor. [3, 4]
• Monitoring: In case of long-term use, monitor liver function.
• Allergic Reactions: Rare but serious skin reactions (e.g., Stevens-Johnson syndrome) and allergic reactions (e.g., anaphylaxis) can occur. Discontinue use and seek medical attention if rash or other allergic symptoms appear. [3, 4]
• Rectal Irritation: Prolonged or frequent use of suppositories may cause local rectal irritation.

Pharmacokinetics:

• Absorption: Absorption from rectal suppositories is slower and more variable than oral administration, but still effective. Peak plasma concentrations are typically reached within 1-2 hours. [3, 4]
• Distribution: Widely distributed throughout body tissues. It crosses the placenta and is excreted in breast milk. [3, 4]
• Metabolism: Primarily metabolized in the liver via glucuronidation and sulfation pathways. A small portion is metabolized by cytochrome P450 (CYP2E1) to a toxic intermediate (NAPQI), which is normally detoxified by glutathione. [3, 4]
• Half-life: Approximately 2–3 hours in children. [3, 4]
• Elimination: Excreted primarily in the urine as glucuronide and sulfate conjugates. [3, 4]

Side Effects:

Side effects associated with acetaminophen suppositories are generally rare and mild at therapeutic doses: [3, 4]

• Common: Mild rectal irritation or discomfort.
• Less Common: Nausea, vomiting.
• Rare: Hypersensitivity reactions (rash, urticaria, anaphylactic shock), blood disorders (e.g., thrombocytopenia, leukopenia).
• Serious (very rare): Hepatotoxicity in overdose, Stevens-Johnson syndrome.

Drug Interactions:

Acetaminophen can interact with several medications: [3, 4]

• Oral Anticoagulants (e.g., Warfarin): Prolonged use of high doses of acetaminophen may enhance the anticoagulant effect, increasing the risk of bleeding.
• Enzyme Inducers (e.g., Phenobarbital, Phenytoin, Carbamazepine, Rifampicin): May increase the risk of liver damage due to increased formation of the toxic metabolite.
• Chloramphenicol: Acetaminophen may increase chloramphenicol plasma concentrations.
• Zidovudine (AZT): Increased risk of neutropenia.
• Alcohol (in older children/adolescents): Increases hepatotoxicity risk.

Patient Counseling:

• Always follow the dosing instructions provided by your doctor or on the product packaging. Do not exceed the recommended dose or frequency.
• Do not use other acetaminophen-containing products simultaneously to avoid overdose.
• If fever or pain persists, or if new symptoms appear, consult a healthcare professional.
• Keep suppositories stored in a cool place, preferably in the refrigerator, and out of reach of children.
• If the child experiences any unusual symptoms after administration, seek medical advice.
• In case of accidental overdose, seek emergency medical help immediately.

Sources:

• SEDICO Pharmaceutical Co. Official Website: https://www.sedico.net/
• SEDICO Product Catalog (search for paracetamol suppositories): https://www.sedico.net/products/
• Acetaminophen (Paracetamol) - Summary of Product Characteristics (SmPC) - Medicines.org.uk: https://www.medicines.org.uk/emc/product/1000/smpc
• Acetaminophen - DrugBank Online: https://go.drugbank.com/drugs/DB00316
• Acetaminophen 125mg Paediatric Suppositories - Egyptian Drug Directories (e.g., Dawaa.org, Med.tn): https://dw2.org/drug/acetaminophen-125mg-paed-supp-usp-xxiii