 |
| CETAL |
For The Medical Profession Only
/\
® El FIii::n
CETAL \/
Analgesic and Antipyretic
Tablets- Drops - Syrup - Suspension - Suppositories
Composition:
Each dosage unit contains: Tablet Drops Syrup Suspension Suppository
(1 ml) (5 ml) is ml)
Paracetamol 500 mg 100 mg 120 mg 250 mg 120 mg
Properties:
CE'I‘AL°(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,CEl"AL°is often the analgesic or antipyretic oi choice especially in
patients where salicylates or other NSAlDs 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.
Pharmacokinetics:
Paracetamol is rapidly arid almost completely absorbed from the Gl tract. Peak
plasma concentrations occur within ‘A - 2 hours, with slight faster absorption of
liquid preparations. Paracetamol is distributed into most body tissues. Plasma —
protein binding is about 25%. The hall-life in plasma is about 2 hours; slightly
prolonged li'i neonates and in cirrhoticse 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.
Indications:
- Analgesic — antipyretic; to relieve mild-to-moderate pain and to reduce lever in the
presence of :
Aspirin allergy, patients with blood coagulation disorders (who are treated with
anticoagulants), bleeding diatheses (e.g, hemophilia), upper Gl 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 dec ease incidence oi
fever and injection site pain. A dose immediately following vacciréon 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:
< 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.
Drug Interactions:
- High doses or long- term use of barbiturates, carbamazepine, hydantoins, riiampin,
sulfinpyrazone, and isoniazid may reduce therapeutic effects and enhance the liver
effects of CEIALP. Avoid use together.
- Coadministration oi wartarin may increase liypoprothrombinemic effects with long--
term use or with high doses of CETALP.
- Zidovudine may increase risk of bone marrow suppression because of impaired
Zidovudine metabolism.
- Caffeine may enhance analgesic effect of CEI)\L@.
- Metoclopramide may accelerate absorption of paracetamol.
- Alcohol may increase risk of hepatotoxicity. Discourage using together.
Precautions:
- CEl‘AL° should be used with caution in:
- Severe hepatic or renal dysfunction
- Patients with alcohol dependence.
- Pregnancy or lactation.
- Unless prescribed by a physician ,(E'I.‘AL" is for short-term use only. Physician
should be consulted it 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.
- Patients should not exceed total recommended dose per day.
- Treatment of overdosage:
Acute overdosage with paracetamol can be extremely serious. Overdosage
exceeding 10 gm paracetamol may cause severe liver damege which may not be
apparent for 48-72 hours after ingestion, Overdosage may be treated by gastric
lavage.Oial 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.
Contraindications:
- Hypersensitivity to the product.
Side Effects:
CEIAL@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:
CEl"AL"'!hblets :Box of 2 blisters each of 10 tablets;Box each of 1000 tablets.
C'EI1\L°Dmpe:Bottle containing 15 ml.
CEl‘AL°Syn1p:Bottle containing 50 ml,60ml,100 ml and 120ml.
CETAL° Su.spension:Bottie containing 60 ml
CEBU.“ Suppositories fbr children: Box of 1 strip of 5 supp0Sil0fi6St
Tlh bl MQIKAIKIL
'M9dlC3Il'i8l'il is a product which affects your health, and its consumption contrary to instructions
is dangerous for you
~Follow strictly the doctor's prescription, the method oi use. and the instructions oi the pharmacist
who sold the medicament
~The doctor and the pharmacist are experts in medicine its benefits and risks
-Do not interrupt the period cl treatment prescribed by yourself
‘Do not repeal the same prescription wlthout consulting your doctor.‘ ~
~Keep medicines out oi the reach of children
Ex.21-12-2005 PMS: 072C.16X16CM 56 g/m2 222 100 PAM 150
EEEEEEEEEEEEEEEEEEEEEEEEEEEEEEEEEEEEEEEEEEEEEEEEEEEEEEEEEEEEEEEEEEEEEEE
EGYPTIAN INT. PHARMACEUTICAL INDUSTRIES CO.
E. I. P. I. CO.
10"‘ OF RAMADAN CITY , AREA B1 P.O.BOX 149 TENTH, EGYPT
