COMPOSITION :
Each chewable tablet and 5 ml (teaspoonful) suspension contain : Mebendazole USP 100 mg. DESCRIPTION :
Dodex (Mebendazole) is a benzimidazole carbamate derivative, it is an anthelmintic with activity against most nematodes and some other worms, activity against some larval stages and ova has also been demonstrated. Mebendazole's anthelmintic activity is considered to be depending on the inhibition or destruction of cytoplasmic microtubules in the worm's intestinal or absorptive cells. Inhibition of glucose uptake and depletion of glycogen stores follow as do other inhibitory effects leading to death of the worm within several days. Mebendazole is poorly absorbed from the gastro-intestinal tract. It is metabolized in the liver, eliminated in the bile as unchanged drug and metabolites and excreted in the faeces. Only about 2% of a dose is excreted unchanged or as metabolites in the urine. 90% of the small absorbed amount of Mebendazole is bound to plasma protein. INDICATIONS :
Dodex is indicated in the treatment of single or mixed infestations by Enterobius vermicularis (pinworm), Trichuris trichura (whipworm), Ascaris lumbricoides (large roundworm), Ancylostoma duodenale, Necator americanus (hookworm), Strongyloides stercoralis (threadworm),Taenia spp. (tapeworm). DOSAGE & ADMINISTRATION : Dodex is administered orally as follows :
Parasitic Infection Recommended Dosage
Adults and children over 2 years : 100 mg (one tablet or 5 ml suspension) as single dose, repeated if necessary after 2 and 4 weeks.
Adults and children over 2 years : 100 mg (one tablet or 5 ml suspension) twice daily morning and evening for 3 consecutive days.
Enterobiasis
Ascariasis, trichuriasis, hookworm and mixed infections
Taeniasis and strongyloidiasis
Adults : 200 mg (two tablets or 10 ml suspension) twice daily morning and evening for 3 consecutive days.
Children over 2 years : 100 mg (one tablet or 5 ml suspension) twice daily morning and evening for 3 consecutive days.
RESTRICTIONS ON USE : Contraindications Mebendazole contraindicated in patients shown Hypersensitivity to it. Precautions
- Mebendazole should only be given to very young children (infants below 1 year age) if their worm infection interferes significantly with nutritional status and the physical development.
- Patients receiving high doses of mebendazole, should be supervise closely with blood counts and liver function being monitored.
Use in Pregnancy and lactation
Mebendazole not recommended during pregnancy and use only if the benefites justifies the risk to the fetus particularly during the first trimester. Caution should be exercised when Mebendazole is administered to nursing women. DRUG INTERACTIONS :
- The concomitant administration of Cimetidine has been reported to raise plasma concentration of Mebendazole.
- The concomitant administration of Phenytoin or Carbamazepine has been reported to lower plasma concentration of Mebendazole. SIDE EFFECTS : The side effects of mebendazole is minor in most cases:
- Transient abdominal pain and diarrhoea have occasionally been reported in cases of massive infestation and expulsion of worms.
- Hypersensitivity reactions : exanthema, rash, urticaria and angio-oedema have rarely been observed.
STORAGE INSTRUCTIONS :
Tablets : Store between 15 - 30ºC, in a dry place.
Suspension : Store between 15 - 30ºC. PRESENTATIONS :
Dodex Chewable tablets : Pack of 6 tablets and hospital packs of different sizes. Dodex Suspension : Bottle of 30 ml.
INSTRUCTIONS TO THE PATIENT
- Medicament 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 of use and the instructions of the pharmacist who sold the medicament.
- The doctor and the pharmacist are experts in medicine, its benefits and risks.
- Do not by yourself interrupt the period of treatment prescribed for you.
- Do not repeat the same prescription without consulting your doctor.
Keep medicament out of reach of children Mfd. By
P.O. Box : 4265 Sana’a /Yemen.
Council of Arab Health Ministers Union of Arab Pharmacists
012-06-069 11/13