Helmedazole - instructions for use, dose, side effects, contraindications

Active substanceMebendazoleMebendazole

Similar drugsTo uncover

Vermox

pills inwards

GEDEON RICHTER, OJSC Hungary

Worming

pills inwards

Cadil Pharmaceuticals Co., Ltd. India

Helmedazole

pills inwards

AVVA RUS, OJSC Russia

Dosage form: & nbsppills

Composition:Active substance: mebendazole (in terms of 100 % substance) - 100.0 mg; Excipients: corn starch - 72.0 mg, silicon dioxide colloid - 3.0 mg, talc - 3.0 mg, magnesium stearate - 3.0 mg, crospovidone - 3.0 mg, sodium lauryl sulfate - 0.5 mg, lactose monohydrate - to obtain a tablet weighing 300.0 mg.

Description:

Round flat-cylindrical tablets from white to light yellow color with a facet and a risk.

Pharmacotherapeutic group:Anthelminthic remedy

ATX: & nbsp

P.02.C.A.01 Mebendazole

P.02.C.A Benzimidazole derivatives

Pharmacodynamics:

Anthelminthic drug of a wide spectrum of action; The most effective Enterobius vermicularis, Trichuris trichura, Ascaris lumbricoides, Ancylostoma duodenale, Necator americanus, Strongyloides stercoralis, Taenia solium, Echinococcus granulosus, Echinococcus multilocularis, Trichinella spiralis, Trichinella nativa, Trichinella nelsoni. Causing an irreversible violation of glucose utilization, depletes glycogen stores in helminth tissues, interferes with the synthesis of cellular tubulin, and also inhibits the synthesis of adenosine triphosphate (ATP).

Pharmacokinetics:

Virtually not absorbed in the intestine. After taking the drug at a dose of 100 mg twice a day for three consecutive days, the plasma concentration of mebendazole and its metabolite (2-amino derivative) does not exceed 0.03 μg / ml and 0.09 μg / ml, respectively.The connection with plasma proteins is 90%. It is distributed unevenly in the organs, accumulates in adipose tissue, liver, larvae of helminths. In the liver

is metabolized to a 2-amino derivative that does not have anthelmintic activity. The half-life is 2.5-5.5 hours. More than 90% of the dose is removed through the intestines in unchanged form. The absorbed part (5-10%) is excreted by the kidneys.

Indications:

Enterobiosis, ascariasis, ankylostomidosis, strongyloidiasis, trichocephalosis, trichinosis, and shadowosis, both with monoinvasion and mixed helminthiases; echinococcosis (with the impossibility of surgical treatment).

Contraindications:

- Increased sensitivity to mebendazole, other components of the drug,

- ulcerative colitis,

- Crohn's disease,

- liver failure,

- children's age (up to 3 years),

- pregnancy,

- lactation period,

- lactose intolerance,

- deficiency of lactase,

- glucose-galactose malabsorption,

- simultaneous reception with metronidazole, phenytoin, carbamazepine, ritonavir.

Pregnancy and lactation:

Pregnancy.

The use of the drug during pregnancy is contraindicated.

The period of breastfeeding.

There is no data on whether the mebendazole in mother's milk.If it is necessary to use the drug during lactation, it is recommended to stop breastfeeding.

Dosing and Administration:

Inside with a little water.

Adults and children over 3 years.

When enterobiosis - once for 100 mg / day (1 tablet); course of treatment 1 day. Since reinfection with enterobiosis occurs quite often, the treatment should be repeated after 2 and 4 weeks.

It is recommended that all members of the family be treated at the same time.

Ascariasis, trihotsefaleze, hookworm and mixed helminthiasis: 200 mg / day (one tablet in the morning, 1 tablet in the evening); course of treatment 3 days.

With the shadow, strongyloidosis. Adults: 400 mg / day (2 tablets in the morning, 2 tablets in the evening); course of treatment 3 days. Children older than 3 years: 200 mg / day (1 tablet in the morning, 1 tablet in the evening); course of treatment 3 days.

With echinococcosis. Adults and children over 14 years: in the first three days of 500 mg 2 times a day, for the next 3 days, increase the dose to 500 mg 3 times a day; in the future, the dose is increased to 1000-1500 mg 3 times a day. The average duration of treatment for echinococcosis caused by Echinococcus granulosis, is 4-6 weeks, caused by Echinococcus multilocularis - Up to two years.

When trichinosis 1 day, 3 times a day, 200-300 mg, the 2nd day four times a day for 200- 300 mg, and from 3 to 14 days - 3 times a day at 500 mg.

Side effects:

Allergic reactions: skin rash, hives, angioedema, Stephen-Johnson syndrome, toxic epidermal necrolysis, exanthema, anaphylactic and anaphylactoid reactions.

On the part of the organs of hematopoiesis: neutropenia.

On the part of the digestive system: nausea, vomiting, abdominal pain, diarrhea, increased activity of "liver" transaminases, alkaline phosphatase, hepatitis (when used in high doses for a long time).

From the nervous system: dizziness, headache, drowsiness, convulsions.

From the side of the urinary system: hypercreatininaemia, glomerulonephritis (when used in high doses for a long time).

Other: hair loss (when used in high doses for a long time).

Overdose:

Symptoms: abdominal pain, nausea, vomiting, diarrhea. When used in high doses for a long time: reversible violations of the liver, hepatitis, neutropenia.

Treatment: it is necessary to remove the drug from the stomach, causing vomiting or rinsing the stomach, taking activated charcoal, symptomatic therapy.

Interaction:

Reduces the need for insulin in patients with diabetes mellitus.

Do not use lipophilic agents at the same time.

Cimetidine can increase the concentration in the blood, carbamazepine and other inducers of metabolism - reduce, in connection with which it is necessary to control the concentration of drugs in the blood serum.

The simultaneous use of mebendazole and metronidazole should be avoided.

Special instructions:

The drug contains lactose, so this drug is contraindicated for patients with rare hereditary lactose intolerance, lactase deficiency or impaired glucose / galactose absorption.

In patients with diabetes it is necessary to monitor the concentration of glucose in the blood plasma.

At long reception it is necessary to supervise a picture of peripheric blood, function of a liver and kidneys.

Within a day after taking, ethanol, fatty foods, and laxative preparations are prohibited.

Periodic examination of the anal and feces smears after the end of treatment is mandatory: therapy is considered effective in the absence of helminths or their eggs for 7 consecutive days.

The results of the study of the development of the syndrome of Stephen-Johnson and toxic epidermal necrolysis indicate a possible relationship between their occurrence and the simultaneous use of mebendazole and metronidazole. There are no other data documenting cases of such drug interactions. This is why simultaneous use of mebendazole and metronidazole should be avoided.

Effect on the ability to drive transp. cf. and fur:Patients should be careful when driving vehicles and working with machinery, because during treatment, dizziness and drowsiness may occur.

Form release / dosage:

Tablets of 100 mg.

Packaging:

For 6 or 10 tablets in a contour mesh box made of polyvinylchloride film and aluminum foil printed lacquered.

For 1 or 4 contour packs of 6 tablets or 1 contour pack of 10 tablets together with the instructions for use are placed in a pack of cardboard.

Storage conditions:

In a place protected from moisture and light at a temperature of no higher than 25 ° C.

Keep out of the reach of children.

Shelf life:2 years. Do not use the expiration date printed on the package.

Terms of leave from pharmacies:On prescription

Registration number:LP-004187

Date of registration:15.03.2017

Expiration Date:15.03.2022

The owner of the registration certificate:AVVA RUS, OJSC AVVA RUS, OJSC Russia

Manufacturer: & nbsp

AVVA RUS, OJSC Russia

Information update date: & nbsp04.04.2017

Illustrated instructions

Instructions

Helmedazole (Gelmedazol)