EMB-Fatol 400 - instructions for use, dose, side effects, contraindications

auxiliary substances: inside: microcrystalline cellulose 12,00 mg, croscarmellose sodium 40,00 mg, copolyvidone 16.00 mg, macrogol 6000 12.00 mg, lactose 33.40 mg, crospovidone 1.00 mg, calcium hydrogen phosphate 37.40 mg, magnesium stearate 4.00 mg, colloidal silicon dioxide (colloidal silicic anhydride) 4.00 mg; sheath: hypromellose 6.70 mg, titanium dioxide 2.20 mg, macrogol 6000 (polyethylene glycol 6000) 1.70 mg.

Description:

White, round tablets, covered with a shell, with a stamp "400" on one side and a notch for breaking - on the other.

Pharmacotherapeutic group:Anti-tuberculosis drug

ATX: & nbsp

J.04.A.K.02 Ethambutol

Pharmacodynamics:

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. Ethambutol is well absorbed in the lung tissue and can reach a concentration of 5-9 times higher than in the serum, it penetrates well into many tissues and organs.

Intracellular concentration in erythrocytes is twice as high as in serum.

Pharmacokinetics:

Etambutol is rapidly and 80% absorbed from the digestive tract. The minimum inhibitory concentration is 1 mg / ml.

After oral administration of a single dose of 25 mg / kg body weight in 2-4 hours, the maximum serum concentration is 2-5 μg / ml, after 24 hours the concentration is less than 1 μg / ml.

It binds to plasma proteins by 20-30%. Ethambutol is metabolized in the liver to dicarboxylic acid derivatives. The half-life period is 3-4 hours, and with renal insufficiency it lengthens to 8 hours. Within 24 hours more than 50% of the drug dose is excreted unchanged in urine, 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 is approximately 30% of the concentration of the drug in the mother's blood.

Indications:

- Pulmonary tuberculosis;

- extrapulmonary tuberculosis.

Contraindications:

- Hypersensitivity to the drug;

- inflammation of the optic nerve;

- cataract;

- diabetic retinopathy;

- inflammatory diseases of the eyes;

- severe renal insufficiency;

- gout:

- pregnancy;

- lactation;

- Children under 13 years.

Dosing and Administration:

Adults: 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 the age of 13 appoint 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 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
over 100	20 mg / kg bw / day
70-100	15 mg / kg bw / day
below 70	10 mg / kg bw / day
in hemodialysis	5 mg / kg bw / day
on dialysis day	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 anti-tuberculosis drugs that the patient had not previously taken and against which no bacterial resistance was noted.

In complex therapy with ethambutol, isoniazid, para-aminosalicylic acid (PASC), streptomycin, cycloserine, pyrazinamide and ethionamide.

Side effects:

Retrobulbaric 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 visual field).The occurrence of visual impairments 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 after 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.

Overdose:

Measures in case of possible overdose: induce vomiting, rinse the stomach.

Interaction:

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

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

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.

Effect on the ability to drive transp. cf. and fur:Because of the possibility of visual impairment (reduced visual acuity, limitation of the visual field, color-perception disorder with respect to green and red) during ethambutol treatment Do not drive cars and service moving machinery.

Form release / dosage:

Coated tablets, 400 mg.

Packaging:

For 100, 1000 tablets per package.

Storage conditions:

Store at room temperature 25 ° C, in a place protected from light and humidity.

In a place inaccessible to children.

Shelf life:

5 years.

Do not use after the time specified on the package.

Terms of leave from pharmacies:On prescription

Registration number:P N 014969/01

Date of registration:13.05.2009 / 11.09.2012

Expiration Date:Unlimited

The owner of the registration certificate:Rimzer Artsynaimitel, AGRimzer Artsynaimitel, AG Germany

Manufacturer: & nbsp

FATOL ARZNEIMITTEL subsidiary of RIEMSER ARZNEIMITTEL, AG Germany

Representation: & nbspRimzer Artsynaimitel AGRimzer Artsynaimitel AG

Information update date: & nbsp16.05.2017

Illustrated instructions

Instructions

EMB-Fatol 400 (EMB-Fatol 400)