Cetal
Active constituent : paracetamol
Dosage forms : Tablets – Drops – Syrup – Suspension - Suppositories.
Pharmacokinetics:
Paracetamol IS rapidly and almost completely absorbed from GIT . Peak plasma concentrations occur within 1/2 – 2 hours, with slight faster absorption of liquid preparations. Paracetamol is distributed into most body tissues.
Composition :
Each dosage unit contains : Tablet Drops( 1m ) Syrup(5 ml) Suspension(5 ml) Suppository
Paracetamol : 500 mg 100 mg 120 mg 250mg 120 mg
Indications:
*Analgesic-antipyretic to relieve mild-to-moderate pain and to reduce fever in the presence of: Aspirin allergy, patients with blood coagulation disorders (who are treated with anlicoagulants), bleeding diatheses (e.g,hemophilia), upper GIT diseases (e.g, ulcer, gastritis), and gouty arthritis. Arthritic, rheumatic, and muscular pain; and neuralgia.
* Headache, earache, toothache, common colds and flu, sore throat, tonsillectomy, migraine, menstruation, and other bacterial or viral infections.
* Prophylactic use in children receiving DTP vaccination; to decrease incidence of fever and injection site pain. A dose immediately following vaccination and every 4–6 hours thereafter for 2–3 days is suggested.
Dosage and Administration:
Adults: 500 mg –1 gm (1–2 tablets) every 4–6 hours daily; not exceeding 4 gm daily.
Children: The following dosage may be given every 4–6 hours, when necessary up to a maximum of 4 doses in 24 hours:
less than 3 months: 10 mg/kg body weight.
3months–1year: 60-120mg.
1-6years: 120 mg – 250 mg.
6 – 12 years: 250 mg – 500 mg.
Contraindications:
- Hypersensitivity to the paracetamol.
Side Effects:
CETAL is generally well tolerated and may be used safely if therapy is short-term and does not exceed the recommended doses. However, skin rash and other allergic reactions have been reported rarely.
Treatment of overdosage:
Acute overdosage can be extremely serious. Overdosage exceeding 10 gm paracetamol may cause severe liver damage which may not be apparent for 48-72 hours after ingestion. Overdosage may be treated by gastric lavage. Oral N-acetcysteine is a specific antidote for paracetamol toxicity. If patient vomits within 1 hour of adminstration of N-acetylcysteine, repeat the dose. Intravenous adminstration of N-acetylcysteine or methionine may be used.Prompt medical attention is critical.
Drug Interactions:
High doses or long- term use of barbiturates, carbarnazepine, hydantoins, ntarnpln, sulfinpyrazone, and isoniazid may reduce therapeutic effects.
Coadministration of warfarin may increase hypoprothrombinemic effects with long–term use or with high doses of cetal.
Zidovudine may increase risk of bone marrow suppression because of impaired zidovudine metabolism.
Caffeine may enhance analgesic effect of cetal.
Alcohol may increase risk of hepatotoxicity.
Precautions:
CETAL should be used with caution in:
-Severe hepatic or renal dysfunction.
-Patients with alcohol dependence.
-Pregnancy or lactation.
- Unless prescribed by a physician, cetal is for short-term use only.
Physician should be consulted for administering to children for more than 5 days, or to adults for more than 10 days, or for more than 3 days for fever (children and adults).
-High doses or unsupervised long-term use can cause hepatic damage.
-Excessive ingestion of alcoholic beverages may increase risk of hepatotoxicity,
Prepared By:
Dosage forms : Tablets – Drops – Syrup – Suspension - Suppositories.
Pharmacokinetics:
Paracetamol IS rapidly and almost completely absorbed from GIT . Peak plasma concentrations occur within 1/2 – 2 hours, with slight faster absorption of liquid preparations. Paracetamol is distributed into most body tissues.
Composition :
Each dosage unit contains : Tablet Drops( 1m ) Syrup(5 ml) Suspension(5 ml) Suppository
Paracetamol : 500 mg 100 mg 120 mg 250mg 120 mg
Indications:
*Analgesic-antipyretic to relieve mild-to-moderate pain and to reduce fever in the presence of: Aspirin allergy, patients with blood coagulation disorders (who are treated with anlicoagulants), bleeding diatheses (e.g,hemophilia), upper GIT diseases (e.g, ulcer, gastritis), and gouty arthritis. Arthritic, rheumatic, and muscular pain; and neuralgia.
* Headache, earache, toothache, common colds and flu, sore throat, tonsillectomy, migraine, menstruation, and other bacterial or viral infections.
* Prophylactic use in children receiving DTP vaccination; to decrease incidence of fever and injection site pain. A dose immediately following vaccination and every 4–6 hours thereafter for 2–3 days is suggested.
Dosage and Administration:
Adults: 500 mg –1 gm (1–2 tablets) every 4–6 hours daily; not exceeding 4 gm daily.
Children: The following dosage may be given every 4–6 hours, when necessary up to a maximum of 4 doses in 24 hours:
less than 3 months: 10 mg/kg body weight.
3months–1year: 60-120mg.
1-6years: 120 mg – 250 mg.
6 – 12 years: 250 mg – 500 mg.
Contraindications:
- Hypersensitivity to the paracetamol.
Side Effects:
CETAL is generally well tolerated and may be used safely if therapy is short-term and does not exceed the recommended doses. However, skin rash and other allergic reactions have been reported rarely.
Treatment of overdosage:
Acute overdosage can be extremely serious. Overdosage exceeding 10 gm paracetamol may cause severe liver damage which may not be apparent for 48-72 hours after ingestion. Overdosage may be treated by gastric lavage. Oral N-acetcysteine is a specific antidote for paracetamol toxicity. If patient vomits within 1 hour of adminstration of N-acetylcysteine, repeat the dose. Intravenous adminstration of N-acetylcysteine or methionine may be used.Prompt medical attention is critical.
Drug Interactions:
High doses or long- term use of barbiturates, carbarnazepine, hydantoins, ntarnpln, sulfinpyrazone, and isoniazid may reduce therapeutic effects.
Coadministration of warfarin may increase hypoprothrombinemic effects with long–term use or with high doses of cetal.
Zidovudine may increase risk of bone marrow suppression because of impaired zidovudine metabolism.
Caffeine may enhance analgesic effect of cetal.
Alcohol may increase risk of hepatotoxicity.
Precautions:
CETAL should be used with caution in:
-Severe hepatic or renal dysfunction.
-Patients with alcohol dependence.
-Pregnancy or lactation.
- Unless prescribed by a physician, cetal is for short-term use only.
Physician should be consulted for administering to children for more than 5 days, or to adults for more than 10 days, or for more than 3 days for fever (children and adults).
-High doses or unsupervised long-term use can cause hepatic damage.
-Excessive ingestion of alcoholic beverages may increase risk of hepatotoxicity,
Prepared By: