Universal reference book for medicines
Product name: SANOXAL (SANOXAL)

Active substance: albendazole

Type: Anthelmintic preparation

Manufacturer: PROTECH BIOSYSTEMS (India)
Composition, form of production and packaging
Chewing tablets are
light orange, with impregnations of a darker and lighter color, round, flat, with a risk on one side.

1 tab.

albendazole 400 mg

[PRING] sucrose 382 mg, lactose 200 mg, sodium benzoate 1 mg, dye sunset yellow (dye yellow) 0.2 mg, purified water 0.1 mg, magnesium stearate 6 mg, talc 10.6 mg, flavor of peppermint (essence of peppermint) - 0.008 mg, menthol (levomenthol) - 0.2 mg.

1 PC.
- packings of cellular contour (1) - packs cardboard.
2 pcs.
- packings of cellular contour (1) - packs cardboard.
3 pcs.
- packings of cellular contour (1) - packs cardboard.
INSTRUCTION FOR THE SPECIALIST.

Description of the drug approved by the manufacturer for the printed edition of 2015.

PHARMACHOLOGIC EFFECT

Anthelmintic and antiprotozoal .
Selectively inhibits the polymerization of beta-tubulin, which leads to the destruction of cytoplasmic microtubules of intestinal tract cells of helminths; changes the course of biochemical processes (suppresses the utilization of glucose), blocks the movement of secretory granules and other organelles in the muscle cells of roundworms, causing their death. The most effective for larval forms of cestodes is Echinococcus granulosus and Taenia solium;nematodes - Strongyloides stercolatis.
PHARMACOKINETICS

Suction

After oral administration, it is poorly absorbed from the digestive tract due to poor solubility in water.
The drug is rapidly metabolized at the "first pass" through the liver, so the plasma concentrations of albendazole in an unchanged form are negligible and are not determined. Bioavailability when ingestion is low. However, the simultaneous intake of fatty foods significantly increases the absorption and concentration of albendazole in the blood plasma (5 times). C max albendazole sulfoxide is achieved after 2-5 h.
Distribution

Binding to plasma proteins is 70%.
Albendazole is well distributed in the body, reaching high concentrations in urine and bile, liver, wall and fluid of parasitic cysts, cerebrospinal fluid.
Metabolism

Albendazole is rapidly metabolized in the liver with the formation of the primary metabolite - albendazole sulfoxide, which also has anthelmintic activity.Albendazole sulfoxide, in turn, is converted into albendazole sulfone (secondary metabolite) and other oxidized products devoid of pharmacological activity.

Albendazole is the inducer of the microsomal enzymes CYP1A2 in human liver cells.

Excretion

T 1/2 albendazole sulfoxide is 8-12 hours. The drug is excreted in the form of various metabolites in the urine and bile, while the kidney excretion is negligible (less than 1%).

Pharmacokinetics in special clinical cases

Against the background of liver damage, the bioavailability of albendazole increases.
Cmax of albendazole sulfoxide increases by a factor of 2, and T 1/2 lengthens.
In patients with impaired renal function, the clearance of albendazole and its metabolites does not change.

INDICATIONS

- neurocysticercosis caused by the larval form of the pork chain (Taenia solium);

- echinococcosis of the liver, lungs, peritoneum caused by the larval form of the canine tapeworm (Echinococcus granulosus);

- Nematodes: ascariasis, trichocephalus, ankylostomiasis, enterobiasis, strongyloidiasis;

- trematodosis: opisthorchiasis;

- Some protozoal infections: Giardiasis, microsporidiosis;

- mixed helminthiases;

- as an aid in the surgical treatment of echinococcus cysts.

DOSING MODE

The drug is taken orally.
The dose is set individually, depending on the type of helminth and the patient's body weight.
With neurocysticercosis and echinococcosis, patients with a body weight of 60 kg and more are prescribed 400 mg twice a day, with a body weight of less than 60 kg , at a dose of 15 mg / kg / day in 2 divided doses.
The maximum daily dose is 800 mg. The course of treatment for neurocysticercosis - 8-30 days, withechinococcosis - 3 cycles of 28 days with a 14 day break between cycles. With surgical treatment, the duration of drug treatment is 3 courses.
With ascariasis, trichocephalosis, enterobiasis, ankylostomiasis, adults and children over 3 years of age - 400 mg once, if necessary, repeat after 3 weeks.

With giardiasis, adults and children over 3 years old - 400 mg 1 time / day for 3 days.

For strongyloidosis and cestodosis, adults and children over 3 years of age - 400 mg once a day for 3 days, if necessary repeat after 3 weeks.

Tablets can be chewed or swallowed whole.

SIDE EFFECT

On the part of the digestive system: a violation of liver function with changes in functional liver tests (mild or moderate increase in the activity of transaminases), abdominal pain, nausea, vomiting.

From the hemopoietic system: oppression of bone marrow hematopoiesis (leukopenia, granulocytopenia, agranulocytosis, thrombocytopenia, pancytopenia).

From the nervous system: headache, dizziness, meningeal symptoms.

Allergic reactions: skin rash, itching.

Other: increased body temperature, increased blood pressure, acute renal failure, reversible alopecia.

CONTRAINDICATIONS

- children's age till 3 years;

- hypersensitivity to the components of the drug;

- Hypersensitivity to other benzimidazole derivatives.

With caution: oppression of bone marrow hematopoiesis, hepatic insufficiency, cirrhosis of the liver, cysticercosis with involvement of the retina of the eye.

PREGNANCY AND LACTATION

It is not recommended to use during pregnancy, except when alternative treatment is not possible.
Before the start of treatment in women of childbearing age, a pregnancy test is conducted. During and during the month after the end of treatment, reliable contraception is required.
With special care the drug is prescribed during breastfeeding.

APPLICATION FOR FUNCTIONS OF THE LIVER

In patients with impaired renal function, the clearance of albendazole and its metabolites does not change.

APPLICATION FOR VIOLATIONS OF THE FUNCTION OF KIDNEYS

With caution: hepatic insufficiency, liver cirrhosis


APPLICATION FOR CHILDREN

Contraindicated in children under 3 years .
With caution should prescribe the drug to children aged 3 to 6 years .
SPECIAL INSTRUCTIONS

Patients with neurocysticercosis should receive appropriate therapy with GCS and anticonvulsant drugs.
GCS for oral and intravenous administration is used to prevent a sharp increase in blood pressure in the first week of anti-cystic therapy.
It is recommended to control the cellular composition of the blood;
blood tests should be performed at the beginning of each 28 day cycle and every 2 weeks during the treatment with albendazole. When leukopenia occurs, treatment is stopped. Continuation of treatment with albendazole is possible if a decrease in the total content of leukocytes and neutrophilic leukocytes is moderate and does not progress.
If there is a violation of the liver, before and during treatment requires regular laboratory monitoring (every 2 weeks).
In case of a significant increase in the level, hepatic transaminase treatment should be discontinued. However, if the level of liver enzymes returned to the original, then albendazole can be re-assigned, provided that the laboratory parameters are constantly monitored.
With neurocysticercosis with eye damage before the beginning of treatment, retinal examination is necessary in connection with the risk of aggravation of its pathology.

Use in Pediatrics

With caution should prescribe the drug to children aged 3 to 6 years .

OVERDOSE

Treatment: gastric lavage, reception of activated charcoal, symptomatic therapy.

DRUG INTERACTION

When combined, dexamethasone, cimetidine, praziquantel increase the concentration of albendazole sulfoxide in the blood.

TERMS OF RELEASE FROM PHARMACY

The drug is released by prescription.

TERMS AND CONDITIONS OF STORAGE

The drug should be stored out of reach of children, dry, protected from light at a temperature of no higher than 25 ° C.
Shelf life - 3 years.
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