Gelmindazole tablets 100mg, No. 6

• Enterobiasis

• ascariasis

• ankylostomiasis

• strongyloidosis

• trichocephalosis

• trichinosis

• teniasis both with monoinvasion and with mixed helminthiasis;

• echinococcosis (if surgical treatment is impossible).

Inside with a little water.

Adults and children over 3 years old

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

It is recommended that all family members be treated simultaneously.

With ascariasis, trichocephalosis, hookworm and mixed helminthiasis : 200 mg / day (1 tablet in the morning, 1 tablet in the evening); the course of treatment is 3 days.

With teniasis strongyloidosis:

• Adults: 400 mg / day (2 tablets in the morning, 2 tablets in the evening); the course of treatment is 3 days.

• Children over 3 years old: 200 mg / day (1 tablet in the morning, 1 tablet in the evening); the course of treatment is 3 days.

With echinococcosis:

Adults and children over 14 years of age: in the first three days, 500 mg 2 times a day; for the next 3 days, the dose is increased 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.

With trichinosis on the 1st day, 3 times a day, 200-300 mg on the 2nd day, 4 times a day, 200-300 mg and from 3 to 14 days - 3 times a day, 500 mg.

Active ingredient: mebendazole (in terms of 100% substance) - 100.0 mg;

Excipients: corn starch - 72.0 mg, colloidal silicon dioxide - 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.

• Hypersensitivity to mebendazole to other components of the drug

• ulcerative colitis

• Crohn's disease

• liver failure

• children's age (up to 3 years)

• pregnancy

• lactation period

• lactose intolerance

• lactase deficiency

• glucose-galactose malabsorption

• simultaneous administration with metronidazole, phenytoin, carbamazepine, ritonavir.

Trade name of the drug

Helmindazole

International non-proprietary name

Mebendazole

Dosage form

pills

Composition

Active ingredient: mebendazole (in terms of 100% substance) - 100.0 mg;

Excipients: corn starch - 72.0 mg, colloidal silicon dioxide - 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, beveled and scored.

Pharmacotherapeutic group

Anthelmintic agent

ATX code

P02CA01

Pharmacodynamics:

Broad-spectrum anthelmintic drug; Most effective against Enterobiusvermicularis

Causing irreversible disruption of glucose utilization, it depletes glycogen stores in the tissues of helminths, prevents the synthesis of cellular tubulin and also inhibits the synthesis of adenosine triphosphate (ATP).

Pharmacokinetics:

Practically 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 003 ?g / ml and 009 ?g / ml, respectively. Communication with plasma proteins - 90%.

Unevenly distributed throughout the organs, accumulates in the fatty tissue of the liver in helminth larvae. In the liver, it is metabolized to a 2-amino derivative that does not possess anthelmintic activity.

The half-life is 25-55 hours. More than 90% of the dose is excreted unchanged through the intestines. The absorbed part (5-10%) is excreted by the kidneys.

Indications:

• Enterobiasis

• ascariasis

• ankylostomiasis

• strongyloidosis

• trichocephalosis

• trichinosis

• teniasis both with monoinvasion and with mixed helminthiasis;

• echinococcosis (if surgical treatment is impossible).

Contraindications:

• Hypersensitivity to mebendazole to other components of the drug

• ulcerative colitis

• Crohn's disease

• liver failure

• children's age (up to 3 years)

• pregnancy

• lactation period

• lactose intolerance

• lactase deficiency

• glucose-galactose malabsorption

• simultaneous administration with metronidazole, phenytoin, carbamazepine, ritonavir.

Pregnancy and lactation:

Pregnancy

The use of the drug during pregnancy is contraindicated.

Breastfeeding period

There is no data on whether mebendazole passes into breast milk. If necessary, the use of the drug during lactation is recommended to stop breastfeeding.

Method of administration and dosage:

Inside with a little water.

Adults and children over 3 years old

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

It is recommended that all family members be treated simultaneously.

With ascariasis, trichocephalosis, hookworm and mixed helminthiasis : 200 mg / day (1 tablet in the morning, 1 tablet in the evening); the course of treatment is 3 days.

With teniasis strongyloidosis:

• Adults: 400 mg / day (2 tablets in the morning, 2 tablets in the evening); the course of treatment is 3 days.

• Children over 3 years old: 200 mg / day (1 tablet in the morning, 1 tablet in the evening); the course of treatment is 3 days.

With echinococcosis:

Adults and children over 14 years of age: in the first three days, 500 mg 2 times a day; for the next 3 days, the dose is increased 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.

With trichinosis on the 1st day, 3 times a day, 200-300 mg on the 2nd day, 4 times a day, 200-300 mg and from 3 to 14 days - 3 times a day, 500 mg.

Side effects:

Allergic reactions : skin rash urticaria angioedema Steven-Johnson syndrome toxic epidermal necrolysis exanthema anaphylactic and anaphylactoid reactions.

From the side of the hematopoietic organs: neutropenia.

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

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

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

Others : 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 liver dysfunction, hepatitis, neutropenia.

Treatment : it is necessary to remove the drug from the stomach by causing vomiting or by making a gastric lavage; taking activated charcoal; symptomatic therapy.

Interaction:

Reduces the need for insulin in diabetic patients.

Should not be used simultaneously with lipophilic substances.

Cimetidine can increase the concentration in the blood of carbamazepine and other inducers of metabolism - they decrease in connection with which the concentration of drugs in the blood serum should be monitored.

The simultaneous use of mebendazole and metronidazole should be avoided.

Special instructions:

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

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

With prolonged use, it is necessary to monitor the peripheral blood picture, liver and kidney function.

During the day after ingestion, it is forbidden to consume fatty food ethanol and take laxatives.

Periodic examination of smears of the anal area and feces 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 a study of the development of Steven-Johnson syndrome and toxic epidermal necrolysis indicate a possible relationship between their occurrence and the simultaneous use of mebendazole and metronidazole. There is no other data documenting cases of such drug interactions. That is why the simultaneous use of mebendazole and metronidazole should be avoided.

Impact on the ability to drive vehicles. Wed and fur .:

Patients should be careful when driving and working with equipment, since dizziness and drowsiness may occur during treatment.

Release form / dosage:

Tablets 100 mg.

Packaging:

On 6 or 10 tablets in a blister strip packaging from a film of polyvinyl chloride and printed aluminum foil varnished.

1 2 3 or 4 blister packs of 6 tablets or 1 blister pack of 10 tablets, together with instructions for use, are placed in a cardboard box.

Storage conditions:

In a place protected from moisture and light at a temperature not exceeding 25 ? C.

Keep out of the reach of children.

Shelf life:

2 years.

Do not use before the expiration date stated on the package.

Vacation conditions

On prescription.