Universal reference book for medicines
Product name: EMB-FATOL 400 (EMB-FATOL 400)

Active substance: ethambutol

Type: Anti-TB drug

Manufacturer: RIEMSER ARZNEIMITTEL (Germany) manufactured by FATOL ARZNEIMITTEL subsidiary of RIEMSER ARZNEIMITTEL (Germany) promotion on the territory of the Russian Federation SVCHIC (Russia)
Composition, form of production and packaging
The tablets covered with a cover of
white color, round, with a stamp "400" on one side and a notch for breaking up - on another.

1 tab.

ethambutol hydrochloride 400 mg

Auxiliary substances: microcrystalline cellulose - 12 mg, croscarmellose sodium - 40 mg, copolyvidone - 16 mg, macrogol 6000 - 12 mg, lactose - 33.4 mg, crospovidone - 1 mg, calcium phosphate secondary acid - 37.4 mg, magnesium stearate - 4 mg, silicon dioxide colloid (silicon anhydride colloidal) - 4 mg.

The composition of the membrane: hypromellose - 6.7 mg, titanium dioxide - 2.2 mg, macrogol 6000 (polyethylene glycol 6000) - 1.7 mg.

100 pieces.
- polypropylene containers (1) - cardboard packs.
INSTRUCTION FOR THE SPECIALIST.

Description of the drug approved by the manufacturer for the print edition of 2007.

PHARMACHOLOGIC EFFECT

[I] - Instruction on medical use approved by the Pharmacological Committee of the Ministry of Health of the Russian Federation on 25.05.2000.

Etambutol is a chemotherapeutic agent with a bacteriostatic effect on typical and atypical mycobacteria tuberculosis.
The mechanism of action of the drug is associated with rapid penetration into the cell, where the lipid metabolism, RNA synthesis is violated, magnesium and copper ions bind, the ribosome structure and protein synthesis in bacterial cells are disrupted. Affects intracellular and extracellular bacterial species. Primary resistance to the drug has about 1% of patients.Etambutol is well absorbed in lung tissue and can reach a concentration 5-9 times higher than in serum; well penetrates into many tissues and organs.
Intracellular concentration in erythrocytes is 2 times higher than in serum.

PHARMACOKINETICS

Etambutol is rapidly and 80% absorbed from the digestive tract.
The minimum inhibitory concentration is 1 mg / ml.
After ingestion of a single dose of 25 mg / kg of body weight after 2-4 hours, C max in the serum is 2-5 μg / ml, after 24 hours the concentration is less than 1 μg / ml.

It binds to plasma proteins by 20-30%.

Etambutol is metabolized in the liver to dicarboxylic acid derivatives.
T 1/2 is 3-4 hours, and with renal insufficiency is prolonged to 8 hours. Within 24 hours of the more accepted 50% dose is excreted in the urine unchanged, and 8-15% - in the form of inactive metabolites. About 20-22% of the initial dose of the drug is excreted with feces unchanged.
Etambutol penetrates the placenta.
In fetal blood, the concentration of ethambutol c leaves about 30% of the concentration of the drug in the mother's blood.
INDICATIONS

- pulmonary tuberculosis;

- extrapulmonary tuberculosis.

DOSING MODE

Adults : in the initial treatment period: 15 mg / kg body weight / day - single dose;
continuous treatment: usually 20 mg / kg body weight / day.
The dose can be increased to 30 mg / kg of body weight per day (but not more than 2.0 g) during the initial treatment period, with relapse of the disease, with the resistance of Koch sticks to other anti-tuberculosis drugs.

Children from 13 years are appointed at the rate of 15-25 mg / kg body weight (but not more than 1.0 g).
The full course of treatment lasts 9 months.
In renal diseases, the dose depends on the degree of renal failure, the index of which is the creatinine clearance (QA).

CK (ml / min) Daily dose

more than 100 20 mg / kg bw / day

70-100 15 mg / kg bw / sug

below 70 10 mg / kg bw / day

with hemodialysis 5 mg / kg bw / day

on the day of dialysis 7 mg / kg bw / day

In patients who have previously taken drugs with tuberculostatic action, the resistance of bacteria develops more often.
In such cases, ethambutol should be taken with at least one or two antituberculosis drugs that the patient has not previously taken and for which no bacterial resistance has been noted.
In complex therapy with ethambutol, isoniazid, para-aminosalicylic acid (PASC), streptomycin, cycloserine, pyrazinamide and ethionamide are used.

SIDE EFFECT

- retrobulbar inflammation of the optic nerve, one-sided or bilateral (weakening of visual acuity, violation of color perception, the presence of central or peripheral scotoma, limitation of the field of vision).
The occurrence of visual impairment depends on the duration of treatment and the existing diseases of the eyeball. If they occur, ethambutol treatment should be discontinued. The vision changes are usually reversible, after the cessation of treatment disappear in a few weeks, in some cases in a few months. In exceptional cases, changes in the eyeball are irreversible due to atrophy of the optic nerve;
- Allergic reactions: skin rash, skin itching, joint pain, fever, leukopenia;

- gastrointestinal disorders;
metallic taste in the mouth, nausea and vomiting, abdominal pain, lack of appetite;
- headaches and dizziness, confusion, orientation disorder, hallucinations, convulsions;

- an increase in the level of uric acid in the blood serum, the phenomenon of urine acid diathesis.

CONTRAINDICATIONS

- hypersensitivity to the drug;

- Inflammation of the optic nerve;

- cataract;

- diabetic retinopathy;

- Inflammatory eye diseases;

- severe renal insufficiency;

- gout;

- Pregnancy;

- lactation period;

- Children's age till 13 years.

PREGNANCY AND LACTATION

The use of the drug is contraindicated in pregnancy and lactation.

APPLICATION FOR FUNCTIONS OF THE LIVER

In renal diseases, the dosage of the drug depends on the degree of renal failure, the index of which is the creatinine clearance.

Creatinine clearance (ml / min) Daily dose

more than 100 20 mg / kg bw / day

70-100 15 mg / kg bw / day

below 70 10 mg / kg bw / day

with hemodialysis 5 mg / kg bw / day

on the day of dialysis 7 mg / kg bw / day

APPLICATION FOR CHILDREN

Contraindicated: children under 13 years.

Children from 13 years of age are prescribed from the calculation of 15-25 mg / kg body weight (but not more than 1.0 g). The full course of treatment lasts 9 months.

SPECIAL INSTRUCTIONS

In patients with renal insufficiency, the dose of ethambutol should be reduced because of the accumulation of the drug in the body.
Before starting treatment with ethambutol, ophthalmic control should be carried out periodically: examination of the fundus, visual fields, visual acuity and color perception.
It is recommended to perform periodic monitoring of liver, kidney and general blood test.

Impact on the ability to drive vehicles and manage mechanisms

Because of the possibility of visual impairment (reduced visual acuity, visual field limitation, color perception in relation to green and red) during the treatment with ethambutol, do not drive machines and maintain moving mechanical equipment.

OVERDOSE

Treatment: induce vomiting, rinse stomach.

DRUG INTERACTION

Aluminum hydroxide reduces the absorption of ethambutol from the digestive tract.

Etambutol alters the metabolism of certain trace elements, mainly zinc.

TERMS OF RELEASE FROM PHARMACY

The drug is released by prescription.

TERMS AND CONDITIONS OF STORAGE

Store at room temperature 25 ° C, protected from light and humidity, out of reach of children.

Shelf life - 5 years.

Do not use after the time specified on the package.

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