Cetal syrup, drops, suspension and suppositories

Cetal composition :

Cetal properties:

CETAL (paracetamol) has analgesic and antipyretic properties with an efficacy comparable to those of aspirin. It does not inhibit platelet aggregation, affect prothrombin response or produce gastrointestinal (GI) ulceration. Therefore, it is often the analgesic or antipyretic of choice especially. in patients where salicylates or other NSAIDs are contraindicated, such as those with a history of peptic ulcer, asthma; in children or elderly patients. It produces analgesia by blocking pain impulses, probably by inhibiting prostaglandins or other substances that sensitize pain receptors. The antipyretic action may due to the effect on the hypothalamic heat- regulating center, which increases dissipation of body heat via vasodilation and sweating.

Cetal pharmacokinetics:

Paracetamol is rapidly and almost completely absorbed from Gl tract. Peak plasma concentrations occur within 1/2 – 2 hours, with slight faster absorption of liquid preparations. Paracetamol is distributed into most body tissues. Plasma – protein binding is about 25%. The half-Iife in plasma is about 2 hours; slightly prolonged in neonates and in cirrhotics. Paracetamol is extensively metabolized In the liver and excreted in urine primarily as inactive glucuronate and sulphate conjugates (94%). Less than 5% is excreted as unchanged paracetamol.

Cetal 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 GI diseases (e.g, ulcer, gastritis, hiatus hernia), 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.

Cetal 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:< 3 months: 10 mg/kg body weight (reduce to 5 mg/kg, if jaundiced).
3 months – 1 year: 60 -120 mg .
1-6 years: 120 mg – 250 mg.
6 – 12 years: 250 mg – 500 mg.

Cetal drug interactions:

– High doses or long- term use of barbiturates, carbarnazepine. hydantoins, ntarnpln, sulfinpyrazone, and isoniazid mayreduce therapeutic effects and enhance the liver effects of it. Avoid use together.
– Coadministration of warfarin may increase hypoprothrombinemic effects with long–term use or with high doses of it.
– Zidovudine may increase risk of bone marrow suppression because of impaired zidovudine metabolism.
– Caffeine may enhance analgesic effect of it.
– Metoclopramide may accelerate absorption of paracetamol.
– Alcohol may increase risk of hepatotoxicity. Discourage using together.

Cetal precautions:

– It should be used with caution in:
– Severe hepatic or renal dystunctlon.
– Patients with alcohol dependence.
– Pregnancy or lactation. . .
– Unless prescribed by a physician ,CETAL is for short-term use only. Physician should be consulted if administering tochildren 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,
– Patients should not exceed total recommended dose per day.

Cetal treatment of overdosage:

Acute overdosage with paracetamol 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-acetylsteine 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.

Cetal contraindications:

– Hypersensitivity to the product.

Cetal side effects:

It 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 .

Packaging:

Tablets :Box of 2 blisters each of 10 tablets;Box each of 1000 tablets.
Drops:Bottle containing 15 ml.
Sytup:Bottle containing 50 ml,60ml,100 ml and 120ml.
Suspension:Bottle containing 60 ml.
Suppositories fur children: Box of 1 strip of 5 suppositories.

Produced by :

EGYPTIAN INT. PHARMACEUTICAL INDUSTRIES CO.
E.I. P.I. CO