Fugacar Janssen Chocolate Infection treated 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 chocolate incense is indicated in the following cases:
ATC code: P02CA01
Active mechanism
In the indications for treatment, Mebendazol operates on the spot in the intestinal tract by hindering the formation of cellular microcks in the worms. Mebendazole binds specific to the micro tube and causes superstitious degenerative changes in worms. Therefore, leading to disorders of glucose absorption and digestive function of worms causing self -resolution process.
pharmacokinetic
absorption
After oral use, Distribution
Mebendazol's cohesion of plasma proteins is about 90 to 95%. The distribution of 1 to 2 l/kg shows that Mebendazole can penetrate the non -circuit organization. This is proved by data about tissue concentration in patients with chronic treatment with Mebendazol (for example, a dose of 40mg/kg/day for 3-21 months).
Metabolism
Mebendazol is used by oral is metabolized mainly by the liver. The plasma concentration of the main specialized substances (amino and amino hydroxylation of Mebendazol) is much higher than that of Mebendazol. The impaired liver function, poor metabolism or decline in biliary exhaust can lead to higher plasma mebendazol levels.
Elimination
Mebendazol, the types of links of Mebendazol 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 3-11 months), leading to a stable concentration of 3 times higher than using a single dose.
Preli clinical research
The toxic assessment of a single dose in many different species shows that Mebendazol is well tolerated and has a wide range of safety. The result of toxic toxicity, oral use, repeated dose on rats when using toxic doses 40mg/kg (240 mg/m2) and higher shows that the weight of the liver is changed, the central lobes are mild, not shaped in the liver cells and the testicular weight changes with degeneration of the tube, flaking and significantly inhibiting sperm activity.
Cancer and mutations
Non -cancer drugs on rats and rats. Intro gene mutation studies show that the drug is not causing mutations.
In Vivo tests found that there was no chromosomal structure destruction. The microscopic test results show that the effects on the division of cells in the vegetative cells of mammals are on the level of drug concentration in plasma 115 ng/ml.
toxicity on fertility
At toxic doses for rats, single -kilograms of 10mg/kg (60mg/m2) and higher, can be toxic to embryos and monitor. Observing in mice, poison for mouse 10mg/kg (60mg/m2) and higher also causes teratogenic and poisoning on the fetus. There is no remarkable harm to reproduction on other research animals.
Reproduction
The fertility of male rats is not affected when the dose is up to 40mg/kg (240 mg/m2) for 60 days. When Cai rats take a dose of up to 10mg/kg body weight in 14 days before pregnancy and during pregnancy, there is no significant effect on the fetus and mouse. However, the reduction of pregnancy has been observed when the rats are used by 40mg/kg (240 mg/m2).
Before taking Fugacar Janssen Chocolate Infection treated one or more intestinal worms (1 tablet)
How to use
No need to apply special ways such as diet or laxative.
Dosage
Use 1 single tablet.
Special population
Children
Use 1 single dose.
Children
Due to the risk of convulsions, contraindicated use of fugacar for children under 1 year of age to treat a series of cases of one or more types of worms (see contraindicated, cautious when used).
Fugacar has not been widely studied in children under 2 years old. Therefore, only using Fugacar for children from 1-2 years old if the potential benefits are greater than the potential risk (see caution when using).
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 case of granulocytosis and nephritis - platelets, these adverse reactions are also reported in patients treated with Mebendazol at the standard dose (see unwanted effects - after -sales data).
Signs and symptoms
In accidentally taking overdose, abdominal spasms, nausea, vomiting and diarrhea may be encountered.
Treatment
There is no specific antidote. Can use activated carbon if appropriate.
What to do when you forget the dose? However, if close to the next dose, skip the forgotten dose and take the next dose at the time as planned. Note that it should not be used double the prescribed dose.
Side Effects
When using chocolate fugacar, you may experience unwanted effects (ADR).
This section presents the adverse reactions that have been reported. The adverse reactions are unfavorable events noted that the use of Mebendazol based on comprehensive evaluation of available information about adverse events. It is not possible to be sure that there is a causal relationship between adverse events with Mebendazol 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 Fugacar is assessed in 39 clinical trials on 6276 patients 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 Table 1. The adverse reaction is reported Classification by system/agency Agriculture reaction Abdominal discomfort. diarrhea. flatulence. rash. The adverse reactions of Fugacar (Mebendazol) are first determined during after -sales process shown in Table 2. In this table, the frequency classification is based on the following convention: Very common> 1/10. common> 1/100 and less> 1/1000 and 1/10000 and Very rare In Table 2, the adverse reactions are presented according to the frequency classification based on the spontaneous reporting rate. Table 2. Fugacar's adverse reactions are determined during after -sales process with the frequency classification of estimated on spontaneous reporting ratio. Classification of agencies Frequency classification Very rare neutrophilia. Very rare Very rare Very rare Very rare Very rare Notify the doctor with unwanted effects when using the drug.
Warnings
Before using the drug you need to read the instructions carefully and refer to the information below.
Contraindicated
Fugacar chocolate medicine is contraindicated in the following cases:
Be cautious when using
Caution when using fugacar 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).
To reduce the risk of choking, it is advisable to consider using fugacar in the form of oral fluid for patients such as children who cannot swallow the tablet form.
Rare reports on liver dysfunction can recover, hepatitis, and neutropenia in patients treated with Mebendazol at standard doses in indicated diseases (see unwanted effects - after -sales data). These events, along with nephritis - platelets, are also reported when using the dose higher than the recommended and treated dose levels in a long time.
Results from a case-Control Study study research on the appearance of Stevens-Johnson syndrome/poisoned epidermal necrosis (SJS/Ten) suggesting the possibility of SJS/Ten and simultaneous use of mebendazol and metronidazol. There is no additional data on drug -drug interaction. Therefore, avoid simultaneous use of Mebendazol and Metronidazol.
The ability to drive and operate machinery
Fugacar Chocolate 500mg incense does not affect alertness and driving ability.
Pregnancy
Mebendazole shows signs of toxicity and teratoma in rats and mice. There is no harm to the reproduction of other experimental animals (see preclinical information).
Should consider the risk of possible and the desired treatment benefits when prescribing Fugacar 500mg for pregnant women, especially in the first 3 months of pregnancy.
Breastfeeding period
It is not known whether Mebendazol is excreted through breast milk. Therefore, be careful when using fugacar 500mg for nursing women.
Reproduction
Research results on the fertility of Mebendazol shows no effect on fertility at the dose of ≤ 10mg/kg/day (60mg/m2) (see clinical information).
Drug interaction
Use at the same time with cimetidine can inhibit the metabolism of Mebendazol in the liver, the result increases the drug concentration in plasma, especially in the long -term treatment.
Should avoid simultaneous use of mebendazol with metronidazol (see caution when used).
Storage
Store at 15 ° C - 30 ° C.
Expiry date: 5 years from the date of production.
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