Tradename

Vormitol, Vormitol

International non-proprietary name

Albendazole + Ivermectin, Albendazole + Ivermectin

Compound

Each chewable tablet contains:

active substance: Albendazole USP 400 mg,

Ivermectin BP 6 mg excipients: Q . S

Dosage form

Tablets.

Pharmacological properties

Albendazole

The main mechanism of action of albendazole is his inhibitory action on the tubulin polymerization, which leads to the loss of cytoplasmic microtubules.

With these indications for treatment, albendazole is active against larval forms of the following microorganisms: Echinococcus granular, Taenia solium Ivermectin

Ivermectin is a member of the avermectin class, broad-spectrum antiparasitics with a unique mechanism of action. Compounds of this class selectively and With high affinity bind to glutamate-gated chloride ion channels, which are found in invertebrate nerve and muscle cells. This leads to an increase in the permeability of the cell membrane for chloride ions with hyperpolarization of a nerve or muscle cell, which leads to paralysis and death of the parasite. Connections of this class can also interact with other ligand-driven chloride channels such how channels, managed neurotransmitter gamma-aminobutyric acid (GABA).

Indications for use

For the treatment of nematode infestations.

Contraindications

Albendazole is contraindicated in patients with known hypersensitivity to compounds of the benzimidazole class or any components albendazole.

Special instructions and precautions

Albendazole

Reported about rare lethal outcomes associated with the use of albendazole, due to granulocytopenia or pancytopenia. It was albendazole has been shown to cause bone marrow depression, aplastic anemia, and agranulocytosis in patients with and without hepatic impairment. All patients should have their blood counts monitored at the start of each 28-day cycle of therapy and every 2 weeks. on the background therapy albendazole. Patients with liver disease, including hepatic echinococcosis, appear to be more at risk of bone marrow suppression resulting in pancytopenia, aplastic anemia, agranulocytosis, and albendazole-associated leukopenia, and require more careful monitoring of blood counts. Albendazole should be discontinued in all patients if a clinically significant decrease in cell count occurs. blood. Albendazole should not be administered to pregnant women, except in clinical situations where alternative treatment is impractical. Patients not should get pregnant in for at least 1 month after discontinuation of albendazole therapy. If the patient becomes pregnant while taking this drug, albendazole should be stopped immediately. If pregnancy occurs while taking this drug, the patient should be apprised of the potential hazard to the fetus.

Ivermectin

Historical data have shown that microfilaricidal drugs such as diethylcarbamazine citrate (DEC-C) can cause skin and/or systemic reactions of varying severity (Mazzotti reaction) and ophthalmic reactions in patients with onchocerciasis. These reactions are probably due to allergic and inflammatory reactions to the death of microfilariae. In patients treated with ivermectin for onchocerciasis, these reactions may occur in addition to clinical adverse reactions possibly, probably or definitely related to the drug itself.

Information for Patients

Ivermectin should be taken on an empty stomach with water.

Strongyloidiasis: the patient should be reminded of the need to re-examine feces for documentary confirmation absence of Strongyloides infection stercoralis .

Onchocerciasis: The patient should be reminded that treatment with ivermectin does not kill adult parasites of Onchocerca , and therefore re-observation and re-treatment is usually required.

Side effect

•         Pain in belly.

•         head pain.

•          Indigestion or vomiting.

Interaction with other drugs

Albendazole is used to treat the following conditions:

•         Ascariasis, capillariasis, skin migratory larvae, Cysticercus Cellulosae, Echinococcus, Enterocolitis,Filariasis, Elephantiasis, Giardiasis Ivermectin is used to treat the following states:

•         Ascariasis, cutaneous migratory maggot, filariasis, elephantiasis, onchocerciasis, river blindness

•         Scabies, strongyloidiasis

Method of application and doses

1 tablet once a day.

Overdose

Albendazole

Significant toxicity and mortality have been reported in male and female mice at doses greater than 5000 mg/kg; in rats at calculated doses of 1300 to 2400 mg/kg; in hamsters at doses exceeding 10,000 mg/kg; and in rabbits at calculated doses of 500 to 1250 mg/kg. In animals, symptoms appeared in a dose dependent manner and included diarrhea, vomiting, tachycardia and respiratory distress.

Ivermectin

Significant mortality was observed in mice and rats after single oral intake from 25 to 50 mg / kg and from 40 to 50 mg / kg, respectively. No significant lethality was observed in dogs after a single oral dose up to 10 mg/kg. At these doses, treatment-related symptoms observed in these animals included ataxia, bradypnea, tremor, ptosis, decreased activity, vomiting, and mydriasis.

Storage conditions

Store below 30° C , protected from light and moisture.

Keep out of the reach of children!

Best before date

3 years. Do not use after the expiry date stated on the packaging.

Holiday conditions

Released by prescription.

Release form

3 tablets in an aluminum foil blister. 1 blister with instructions for use in a carton box.