Belicide

Trade name: Belicide F.C. tablets

Generic name: Praziquantel

Composition:
Each tablet contains:

Praziquantel 600 mg
Sodium lauryl sulfate 4 mg
Microcrystalline cellulose PH101 (Avicel) 151 mg
Crosscarmellose Sodium (Ac-di-sol) 46 mg
Maize starch 76 mg
Polyvinyl pyrrolidone K90 18 mg
Magnesium stearate 5 mg
Ethyl alcohol 0.2 ml

Film coat:
Each tablet contains:

Eudragit L100 8.78 mg
(equivalent to Eudragit L12.5                      70 mg)
Titanium dioxide (micronized) 8 mg
Talc purified 1.5 mg
Castor oil 7.2 mg
Ethyl alcohol 0.07 ml

Pharmaceutical form: Film coated tablets

Pharmacological actions:
Belicide induces a rapid contraction of schistosomes by a specific effect on the permeability of the cell membrane.
Belicide further causes vacuolization and disintegration of the schistosome tegument.
Secondary effects are inhibition of glucose uptake, lowering of glycogen levels and stimulation of lactate release.

Pharmacokinetics:
After oral administration, Praziquantel is rapidly absorbed (80%), metabolized and eliminated by the kidneys.
Maximal serum concentration is achieved 1–3 hours after dosing.
The half–life of praziquantel in serum is 0.8–1.5 hours.

Indications:
Belicide is indicated for the treatment of infections due to:
- Schistosoma species: Schistosoma mekongi, Schistosoma japonicum, Schistosoma mansoni and Schistosoma haematobium.
- Liver flukes: Clonorchis sinensis/Opisthorchis viverrini.

Dosage & administration:
• Schistosomiasis:
3 × 20 mg/kg body weight as one–day treatment.
The number of tablets to be taken 3 times on the same day is shown in the following table:

Body weight in kg 20-25 26-33 34-41  42-48 49-56 57-63  64-70 71-78 79-86
Dose (mg)  450  600 750  900  1050  1200  1350  1500  1650

Number of tablets corresponding to 1 × 20 mg/kg

¾  1 1 ¼  1 ½  1 ¾  2  2 ¼  2 ½  2 ¾

Clonorchiasis and Opisthorchiasis: 3 × 25 mg/kg body weight as one–day treatment.

Body weight in kg 22-26 27-33 34-38 39-44 45-50 51-56 57-62 63-68 69-75
Dose (mg) 600 750 900 1050 1200 1350 1500 1650 1800

Number of tablets corresponding to 25 mg/kg

1 1 ¼ 1 ½ 1 ¾ 2 2 ¼ 2 ½ 2 ¾ 3

- The tablets should be swallowed with a little liquid, preferably during or after meals.
- The interval between administration should be at least 4 hours and not more than 6 hours.
- Each 600 mg tablet has 3 scores, when broken, each of the 4 segments contains 150 mg of active ingredient.

Contraindications:

Belicide is contraindicated in:
- Patients with hypersensitivity to any of the components of the product.
- Ocular cysticercosis.
   
Side effects:
Digestive system: abdominal pain, nausea, vomiting, anorexia, bloody diarrhea.

Nervous system: dizziness, headache, somnolence, vertigo, convulsion.

Body as a whole: asthenia, fever, allergic reaction including polyserositis.

Cardiovascular system: arrhythmia.

Skin and appendages: urticaria.

Mild increases in liver enzymes.
       
Drug interactions:
- Concomitant administration of phenytoin, carbamazepine, phenobarbital, chloroquine or dexamethasone with Belicide, lowers Belicide serum levels, while cimetidine, miconazole and ketoconazole increase Belicide serum levels.

- Concomitant administration of Belicide and rifampin should be avoided.

Pregnancy:
Belicide should not be used in pregnancy unless clearly needed.

Lactation:
Breast-feeding should be suspended for the day(s) of treatment and the following 72 hours.

Precautions & Warnings:
- Caution should be taken in patients with uncompensated liver insufficiency or with hepatosplenic schistosomiasis.
- Patients suffering from cardiac irregularities should be monitored during treatment with Belicide.
- When schistosomiasis or fluke infection is found in patients living in or coming from areas with endemic human cysticercosis, it is advisable to hospitalize the patient for the duration of treatment with Belicide.
- Patients should be warned not to drive a car and not to operate machinery on the day of Belicide treatment and during the subsequent 24 hours.

Therapeutic category:
Antihelmintic.

Legal category:
POM.

Package:

Box containing 4 tablets.

Storage:

Store in a dry place, at a temperature not exceeding 30°C, protect from light.
THIS IS A MEDICAMENT
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 the experts in medicines, their benefits and risks.
- Do not by yourself interrupt the period of treatment prescribed.
- Do not repeat the same prescription without consulting your doctor.
- Keep all medicaments out of reach of children.

Council of Arab Health Ministers, Union of Arab Pharmacists.