INDICATIONS     CONTRA-INDICATIONS     DOSAGE     SIDE-EFFECTS     PREGNANCY     OVERDOSE     IDENTIFICATION     PATIENT INFORMATION

Logo ADCO-WORMEX 100 mg (Tablets)
ADCO-WORMEX 100 mg/5 mL (Suspension)

SCHEDULING STATUS:
S2

PROPRIETARY NAME
(and dosage form):

ADCO-WORMEX 100 mg (Tablets)
ADCO-WORMEX 100 mg/5 mL (Suspension)

COMPOSITION:
ADCO-WORMEX 100 mg Tablets:

Each tablet contains 100 mg
mebendazole.

ADCO-WORMEX 100 mg/5 mL Suspension:
Each medicine measure (5 mL) contains:        100 mg mebendazole
Preservatives:
  Methyl hydroxybenzoate         0,18% m/v
  Propyl hydroxybenzoate         0,02% m/v

PHARMACOLOGICAL CLASSIFICATION:
A .12 Anthelmintics, Bilharzia medicines, Filaricides, etc.

PHARMACOLOGICAL ACTION:
Mebendazole is a broad-spectrum antihelminthic. It causes selective disappearance of cytoplasmic microtubules in the tegumental and intestinal cells of affected worms. Glucose uptake is thereby selectively and irreversibly blocked in susceptible adult intestine-dwelling helminths and their tissue dwelling larvae.
Inhibition of glucose uptake results in glycogen depletion of the parasite. This in turn results in reduced formation of ATP (Adenosine triphosphate) required for survival and reproduction of the helminth. Corresponding energy levels are gradually reduced until death of the parasite ensues.

INDICATIONS:
Mebendazole is a versatile anthelminthic agent, particularly against gastro-intestinal nematodes. It is indicated for the treatment of single and mixed helminth infestations caused by:-
Nematodes such as:
- Trichuris trichiura (whipworm);
- Ancylostoma duodenale (hookworm);
- Necator americanus (hookworm);
- Ascaris lumbricoides (large roundworm);
- Ternidens deminutus;
- Enterobius vermicularis (pinworm);
- Strongyloides stercoralis (threadworm).
Cestodes such as:
- Taenia spp (tapeworm);
- Infestations by Moniliformis moniliformis.

CONTRA-INDICATIONS:
Adco-Wormex is contra-indicated in persons who have shown hypersensitivity to mebendazole. Adco-Wormex should not be given during pregnancy and lactation.

DOSAGE AND DIRECTIONS FOR USE:
ADCO-WORMEX 100 mg Tablets
may be swallowed whole, or chewed, or crushed and mixed with food or liquid.
ADCO-WORMEX 100 mg/5 mL Suspension provides an alternative liquid formulation.

Whipworm; Hookworm; Large Roundworm; Pinworm; Ternidens deminutus; Infestations by Moniliformis moniliformis:
One tablet (100 mg) or one medicine measureful (5 mL) suspension twice daily (morning and evening) for three consecutive days.
Dosages for children and infants applies to over two years of age.

Tapeworm (Taenia spp):
One tablet (100 mg) or one medicine measureful (5 mL) suspension twice daily (morning and evening) for six consecutive days.
Dosages for children and infants applies to over two years of age.

Threadworm (Strongyloides stercoralis):
Adults:        Two tablets (200 mg) or two medicine measures (10 mL) twice daily (morning and evening) for three consecutive days.
Children: One tablet (100 mg) or one medicine measure (5 mL) twice daily (morning and evening) for three consecutive days.
A second course of treatment should be given to those patients who are still infected three to four weeks after the first course.
In worm-eradication campaigns the standard course should be administered every quarter during the first year.
If a helminth is not susceptible to the standard dosage, a treatment course of longer than three days and/or involving higher doses is recommended.
The efficacy of Adco-Wormex is dependent upon the duration of physical contact between drug and parasite. When gastro-intestinal transit time is accelerated, e.g. in diarrhoea, it may be necessary to repeat the dose at more frequent intervals daily.
For infants under 2 years, see "Side-effects and Special Precautions".

SIDE-EFFECTS AND SPECIAL PRECAUTIONS:
Gastro-intestinal disturbances such as transient abdominal pain and diarrhoea have tended to occur in patients being treated for heavy intestinal infection.
Side-effects in patients treated with high doses include allergic reactions, alopecia, transient neutropenia, agranulocytosis and hypospermia.
In doses exceeding the recommended dosages, vomiting, fever, bone marrow suppression, raised hepatic enzymes, hepatitis and glomerular nephritis can occur.
Hypersensitivity reactions such as exanthema, rash, urticaria and angio-oedema have been observed.
Precautions:
Patients receiving high doses of mebendazole such as those with hydatid disease, should be supervised closely with blood counts and liver function being monitored.
Appropriate studies on the relationship of age to mebendazole effects have not been performed in children up to 2 years of age. It's use is not advised in children less than 2 years old. Adco-Wormex should only be given to very young children if their worm infections interferes significantly with their nutritional status and physical development.
Interactions:
Concomitant treatment with cimetidine may inhibit the metabolism of the mebendazole in the liver, resulting in increased plasma concentrations of the drug especially during prolonged treatment. In the latter case, determination of plasma concentrations is recommended in order to allow dose adjustments.
In patients receiving high doses of mebendazole for treatment of tissue - dwelling organisms such as Echinococcus multi locularis, carbamazepine has been shown to lower mebendazole plasma concentrations by induction of hepatic microsomal enzymes and to impair the therapeutic response.

KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF TREATMENT:
In the event of accidental overdosage, abdominal cramps, nausea, vomiting and diarrhoea may occur. If poisoning or excessive overdosage is suspected it is recommended, on general principles, that vomiting be induced or gastric lavage be performed, and such symptomatic supportive therapy be administered as appears indicated. Activated charcoal may be given.

IDENTIFICATION:
ADCO-WORMEX 100 mg:
Yellow, round, flat bevel-edged tablet with breakline on one side and “ADCO”embossed on the other side.
ADCO-WORMEX 100 mg/5 mL: Smooth, off white coloured and opaque suspension.

PRESENTATION:
ADCO-WORMEX 100 mg:
Blister pack of six tablets, and securitainers containing 300 tablets.
ADCO-WORMEX 100 mg/5 mL: 30 mL Amber glass bottle.

STORAGE INSTRUCTIONS:
Store below 25°C protected from light. Keep out of reach of children.

REGISTRATION NUMBER:
ADCO-WORMEX 100 mg:
27/12/0082
ADCO-WORMEX 100 mg/5 mL: 27/12/0083

NAME AND BUSINESS ADDRESS OF THE APPLICANT:
Adcock Ingram Limited
Adcock Ingram Park
17 Harrison Avenue
Bryanston
Private Bag X69, Bryanston, 2021

DATE OF PUBLICATION OF THIS PACKAGE INSERT:
28/09/2000

New addition to this site: April 2004
Source: Pharmaceutical Industry

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