Pharmaceutical Form
Suspension for oral use.
COMPOSITION
20 ml of suspension
contains
Albendazole 400
mg.
THERAPEUTIC
INDICATIONS
Helmadol is a highly
effective antiparasitic agent of a polyvalent
action; the majority of helminthiases may be
treated with this agent:
- nematodosis:
Ascariasis,
disease-producing factor – nematode helminth
Ascaris lumbricoidesl;
Trichocefales
(whipworm), disease-producing factor – nematode
helminth Trichocephalus trichiurus;
Enterobiasis
(pinworms), disease-producing factor - nematode
helminth Enterobius vermicularis;
Ankylostomiasis,
disease-producing factors – Ancylostoma
duodenale and Necator americanus; trichinosis,
disease-producing factors – meat porkworms;
Toxocariasis,
disease-producing factor - Toxocara canis, dog
parasite;
Strogiloidos (dwarf
threadworm), disease-producing factor – nematode
helminth Strongiloides strcoralis,
And also mixed
invasions;
- Tissue cestodosis:
Cysticercosis
(disease-producing factor - �ysticercus
cellulosus, larval stage of armed tapeworm);
Hydatid disease of
liver, lungs, peritoneum, caused by larval stage
of dog tapeworm (Echinococcus granulosus),
Also the drug is
applied as an additive agent in surgical
treatment of alveolar echinococcosis.
CONTRAINDICATIONS
- Hypersensitivity
to any drug ingredients and other derivatives of
benzimidazole;
- Eye retina
pathology;
- Pregnancy;
- Lactation (breast
feeding).
ADVERSE EFFECTS
Effects on digestive
system: abdominal pains, nausea, vomiting.
Effects on
cardiovascular system: elevation of blood
pressure.
Effects on central
nervous system: headache and dizziness.
Effects on urinary
excretion system: changes of indices of renal
function (acute renal impairment).
Dermatologic
reactions: itching, skin eruption and other
allergic reactions.
DOSAGE AND
ADMINISTRATION
Oral administration
during or after meal intake. Special preparation
and diet is not required.
Use a calibrated
13-ml dosage cap (10 ml, 5 ml and 2.5 ml) for
dosing of suspension.
Choose a drug
formulation individually depending on
convenience of a drug and tolerance of its
compounds.
Determine a dose
individually depending on invasion type,
patient’s body weight. The maximum daily dose is
800 mg.
Ascaridiasis,
trichocefales: for patients with body weight of
60 kg and more - 400 mg daily as a single dose
or 200 mg 2 times a day; for patients with body
weight less than 60 kg – 15 mg/kg daily divided
into two doses.
Enterobiasis: 5
mg/kg of body weight as a single dose. Repeat
the scheme in 14 days.
Strongyloidiasis,
ankylostomiasis 10 mg/kg of body weight daily
within 3 days. Repeat the scheme in 14 days.
Trichinosis: 10
mg/kg of body weight daily divided into two
doses within 7-10 days.
Toxocariasis. 10
mg/kg of body weight daily divided into two
doses after meal within 10 days. Repeat the
scheme in 14 days or a month.
Hydatid
echinococcosis. Treatment is possible if
laboratory indices are within limits. 10 mg/kg
of body weight daily divided into two or three
doses. Therapy course is 3 cycles of 28 days
with 14 day’s interval.
Cysticercosis: 15
mg/kg of body weight daily divided into three
doses. The therapy course is 28-30 days.
OVERDOSAGE
Symptoms:
enhancement of adverse reactions is reported.
Therapy: gastric
lavage, prescription of activated charcoal,
symptomatic therapy.
DRUG INTERACTOINS
Dexamethasone and
cimetidine increases blood Albendazole sulfoxide
concentration.
PRECAUTIONS
Use Helmadol with
cautious in case of hepatic impairment.
Prior treatment make
pregnancy test in women of childbearing age.
Reliable contraception is required during
therapy.
Effects on ability
to drive and operate with mechanisms
The drug does not
cause changes of patient’s psychophysical state,
does not influence on ability for driving and
working with complicated mechanisms.
PREGNANCY AND
LACTATION
Helmadol is
contraindicated during pregnancy and lactation
(breast-feeding).
MANUFACTURED FORM
Helmadol 400 mg/20ml
Homogeneous syrupy
suspension of white color with brownish tint,
banana odor and taste 20 ml (400 mg of
albendazole) is in dark glass vial.
1 vial with a
leaflet and dosage cap is in a carton box.
SALES TERMS
Sold under a
prescription.