Fugacar Janssen does not taste to treat one or more intestinal worms (1 tablet)

Dosage form Tablet
Specifications Box of 1 blister x 1 tablet
Ingredient Mebendazole

Ingredient

Composition information	Content
Mebendazole	500mg

Uses

Indications

Fugacar 500mg drugs are not prescribed in the treatment of cases of one or more intestinal worms: Entobius vermicularis (needle worm); Trichuris Trichiura (hairworm); Ascaris Lumbricoides (roundworm); Ancylostoma duodenale, Necator Americanus (hookworm).

Pharmacokology

In the treatment indications, Mebendazole operates on the spot in the intestinal tract by hindering the formation of cell tube formation in worms. Mebendazole is specific to the micro tube and causes changes in super structural degeneration in worms. Therefore, leading to disorders of glucose absorption and digestive function of worms causing self -resolution process.

pharmacokinetic

absorption

After oral use, less than 10% of the dose is absorbed into the circulatory system due to incomplete absorption and due to large metabolism before entering the circulatory system (initial metabolic impact). The maximum concentration in plasma is usually achieved after 2 to 4 hours of medication.

Take medicine with a fat -rich meal that leads to Mebendazole's bioavailability, although the overall effect of food on the amount of medication in the digestive tract is negligible.

Distribution

Mebendazole's cohesion of plasma proteins is about 90 to 95%. The distribution of 1 to 2L/kg shows that Mebendazole may penetrate the non -circuit organization. This is proved by data about tissue concentration in patients with chronic treatment with Mebendazole (for example, a dose of 40mg/kg/day for 3 - 21 months).

Metabolism

Mebendazole is used by oral. The plasma concentration of the main metabolites (amino and amino hydroxylation of Mebendazole) is much higher than that of Mebendazole. The impaired liver function, poor metabolism or decreased excretion through biliary tract can lead to higher plasma mebendazole levels.

Elimination

Mebendazole, the forms of Mebendazole and its metabolites can undergo many rounds of intestinal circulation and are eliminated through urine and bile. The sale time after a dose is about 3 to 6 hours in most patients.

Stable pharmacokinetic state

Mebendazole concentration and main metabolites in plasma increases when used for a long time (e.g. 40mg/kg/day for 3 - 21 months), leading to concentration at a stable condition 3 times higher than using a single dose.

Special population

Children: Based on a limited number of blood samples, pharmacokinetic results after using the Dose of Mebendazole 500 mg for pediatric patients (from 1 to 16 years old) infected one or more types of hair worms and/or roundworms show that children aged 1 to 3 years old have higher body levels than adults.

Before taking Fugacar Janssen does not taste to treat one or more intestinal worms (1 tablet)

How to use

Oral drugs.

No need to apply special ways such as dieting or laxatives.

Chewing the tablet completely before swallowing, do not swallow the whole tablet.

For patients with difficulty chewing, it is possible to put the pill in a spoon and add about 2ml to 3ml of drinking water. Within 2 minutes, the tablet will absorb water and become a semi -solid soft mass, this time can be taken.

Dosage

Take 1 single tablet.

Special population:

Children: use 1 single dose.

Children

Note: The above dose is for reference only. Specific dosage depends on the condition and level of progression of the disease. For a suitable dose, you need to consult a doctor or medical specialist.

What to do when overdose? Except for the cases of granulocytosis and nephritis - platelets, these adverse reactions are also notified in patients treated with Mebendazole at the standard dose (see unwanted effect - star data when circulating).

What to do when forgetting a dose?

Side Effects

When using the drug, you may experience unwanted effects (ADR).

This section presents the adverse reactions that have been reported. The adverse reactions are adverse events noted that the use of Mebendazole is based on comprehensive evaluation of available information about adverse events. It is not possible to make sure there is a causal relationship between adverse events with Mebendazole in individual cases. Moreover, because clinical trials are conducted in very different conditions, the adverse reaction rate is observed in the clinical trials of a drug that cannot be directly compared to the proportion in other drug clinical trials and cannot reflect the observed rate in clinical practice.

Clinical test data

The safety of the drug is assessed in 39 clinical trials on 6276 patients who are treated for one or more digestive parasites. In 39 clinical trials, no adverse reactions appear ≥ 1% of patients treated with fugacar. The adverse reactions appear

Common, ADR> 1/100

No report.

Uncommon, 1/1000

Digestive disorders: abdominal discomfort, diarrhea , flatulence.

Skin and subcutaneous tissue disorders: rare rash.

No report.

after -sales data (after circulation)

Fugacar's adverse reactions (Mebendazole) were first determined during after -sales process as follows:

Very rare

Blood disorders and lymphatic systems: neutrophilia, grain leukocytes. Usually.

When experiencing side effects of the drug, it is necessary to stop using and notify the doctor or go to the nearest medical facility for timely treatment.

Warnings

Before using the drug you need to read the instructions carefully and refer to the information below.

Contraindicated

Contraindications in the following cases:

Children under 1 year of age in the treatment of a series of cases of one or more types of worms.

In addition, contraindicated use for people who are hypersensitive to drugs or excipients of the drug.

Caution when using

Precautions when taking drugs for children under 2 years old.

In after -sales surveillance, children's seizures including children under 1 year of age are reported with very rare frequency (see unwanted effects).

The drug has not been widely studied in children under 2 years old. Therefore, Fugacar should only be used for children from 1-2 years if the potential benefits are greater than the potential risk (for example, if the child's worm infection is significantly affected by the child's nutrition and physical development).

Rare reports on liver dysfunction can recover, hepatitis, and neutropenia in patients treated with Mebendazole in standard doses in indicated diseases (see unwanted effects - after -sales data). These events, along with nephritis, are also reported when using the dose higher than the recommended and treated dose in a long time.

Results from a case-Control Study study on the appearance of Stevens-Johnson syndrome/poisoning epidermal necrosis (SJS/Ten) suggesting the possibility of SJS/Ten and simultaneous use of Mendazole and Metronidazol. There is no additional data on drug -drug interaction. Therefore, avoid simultaneous use of Mebendazole and Metronidazol.

The ability to drive and operate machinery

The drug does not affect alertness and driving ability.

Pregnancy

Mebendazole shows signs of fetal toxicity and teratoma in rats and mice. There is no harmful effect on the reproduction of other experimental animals.

Should consider the risk of possible and the desired treatment benefits when prescribing fugacar for pregnant women, especially in the first 3 months of pregnancy.

Breastfeeding period

Restricted data from reports shows a small amount of Mebendazole appearing in breast milk after taking the medication. Therefore, be careful when using Fugacar for breastfeeding women.

Reproductive ability

Research results on the fertility of Mebendazole shows no effect on fertility at the dose of ≤ 10 mg/kg/day (60mg/m2).

Drug interaction

simultaneously used with cimetidine can inhibit the metabolism of Mebendazole in the liver, the result increases the concentration of drugs in plasma, especially in the case of prolonged treatment. Should avoid using Mebendazole with Metronidazol.

Storage

Storage below 30 ° C.

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