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Logo COMBANTRIN ORAL SUSPENSION
COMBANTRIN TABLETS
Pyrantel Pamoate
COMBANTRIN
Oral Suspension and Tablets

SCHEDULING STATUS:
Not scheduled

PROPRIETARY NAME
(and dosage form):

COMBANTRIN ORAL SUSPENSION
COMBANTRIN TABLETS

COMPOSITION:
Combantrin oral suspension contains 50 mg pyrantel base as pyrantel pamoate per mL, with 0,3% m/v sodium benzoate added as a preservative.
Combantrin oral suspension includes the following inert ingredients: Antifoam A.F. emulsion, citric acid, polyvinylpyrrolidone K25, lecithin, sodium benzoate, sorbitol solution, glycerin, veegum, tween 80, caramel cream, blackcurrant N 556, and water.
Each Combantrin tablet contains 125 mg pyrantel base as pyrantel pamoate per tablet.
Combantrin tablets include the following inert ingredients: Alginic acid, corn starch for paste, FD& C yellow # 6, magnesium stearate, and sodium lauryl stearate.

PHARMACOLOGICAL CLASSIFICATION:
A.12 Anthelmintics.

PHARMACOLOGICAL ACTION:
Combantrin (oral suspension and tablets) is a single-dose anthelmintic agent, effective against infestations with roundworm (Ascaris lumbricoides), threadworm (Enterobius vermicularis and Trichostrongylus species) and effective against hookworm (Ancylostoma duodenale, Necator americanus and Ternidens deminutus) in children and adults.
Combantrin's action against helminths is that of a neuro-muscular blocking agent which has a paralysing effect resulting in eradication of the invading parasite population.
Combantrin is poorly absorbed from the gastrointestinal tract. Following a single oral pyrantel dose of 11 mg/kg, peak plasma concentrations of 50-130 ng/mL occur within 1-3 hours.
More than 50% is excreted unchanged in the faeces following oral administration; less than 7% is found in the urine unchanged and in the form of metabolites.

INDICATIONS:
Combantrin is specifically indicated for the treatment of infestation with any of the following gastro-intestinal parasites whether these are present alone or as a mixed infestation:
  (i)        Ascaris lumbricoides (roundworm)
  (ii) Enterobius vermicularis (threadworm)
  (iii) Trichostrongylus species
  (iv) Ancylostoma duodenale (hookworm)
  (v) Necator americanus (hookworm)
  (vi) Ternidens deminutus (hookworm)

CONTRA-INDICATIONS:
Combantrin is contraindicated in patients who are hypersensitive to the drug or to any components of the product.
Combantrin is poorly absorbed by the gut and although animal reproductive studies have not resulted in any teratogenic effects, Combantrin has not been studied in the pregnant patient. Accordingly, it should not be used in pregnant women unless in the judgement of the physician it is essential for the welfare of the patient.
It is not known whether Combantrin is excreted in breast milk, nursing should therefore be discontinued, if use of this drug is deemed essential.

DOSAGE AND DIRECTIONS FOR USE:
Combantrin should be administered in a single oral dose of 10 mg per kg of patient body mass as follows: (Maximum dose of 1 g)
AVERAGE
MASS		 RECOMMENDED DOSE: TABLETS
(125 mg)		 RECOMMENDED DOSE: ORAL SUSPENSION
(250 mg/5 mL)		 MEDICINE MEASURE-FULS
Less than 12 kg*                        
12-22 kg         1-2         2,5-5,0 mL         ½-1
22-41 kg         2-4         5,0-10 mL         1-2
41-65 kg         4-6         10,0-15 mL         2-3
Adults over 70 kg         8         20 mL         4
* Use in infants under 2 years is not recommended
Combantrin may be administered without regard to ingestion of food or time of day, and purging is not necessary prior to or during therapy. On rare occasions, a second dose has been necessary to completely eradicate the infestation.
The high degree of palatability of Combantrin oral suspension assures ease of administration to all age groups. If desired, it may be taken with milk or fruit juice.
The presence of an infestation by Enterobius or Ascaris in one member of the family may indicate unidentified infestations in other members of the family. Combantrin treatment for all family members is recommended.
Rigorous cleaning of living quarters and clothing to destroy helminthic ova will help prevent re-infestation.

SIDE-EFFECTS AND SPECIAL PRECAUTIONS:
Clinical experience has shown that Combantrin is well tolerated. Side effects are very infrequent consisting for the most part of anorexia, abdominal cramps, nausea, vomiting and diarrhoea. Other side effects that may occur are: headache, dizziness, drowsiness, insomnia and rash. In a few cases, minor transient elevation of SGOT has been observed.
The effect of Combantrin on the ability to drive and operate heavy machinery has not been studied. There is no evidence to suggest that Combantrin may affect these abilities.

KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT
No toxic effects attributable to Combantrin overdose have been observed. There is no specific antidote for the treatment of overdosage with Combantrin. Treatment is symptomatic and supportive.

IDENTIFICATION:
Combantrin oral suspension: A Yellow suspension having the odour and taste of blackcurrant and caramel.
Combantrin tablets: Round, biconvex, pale orange coloured tablets.

PRESENTATION:
Combantrin oral suspension is available as a pleasant tasting suspension in 15 mL bottles and 45 mL bottles.
Combantrin tablets are packed into a catch cover of 6 tablets.

STORAGE INSTRUCTIONS:
Combantrin oral suspension and tablets should be stored below 30°C. Keep out of the reach of children.

REGISTRATION NUMBERS:
Oral Suspension:         D/12/260
Tablets:         J/12/200

NAME AND BUSINESS ADDRESS OF THE APPLICANT:
Pfizer Consumer Healthcare, division of
Warner-Lambert S.A. (Pty) Ltd.
241 Main Road
RETREAT
7945

DATE OF PUBLICATION OF THIS PACKAGE INSERT:
13 April 2000

Updated on this site: May 2003
Source: Pharmaceutical Industry

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