Combutol - instructions for use, dose, side effects, contraindications

Active substanceEthambutolEthambutol

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Dosage form: & nbsppills

Composition:

1 tablet contains:

active substance: ethambutol hydrochloride (Br.F.) 100 mg, 200 mg, 400 mg, 600 mg, 800 mg or 1000 mg;

Excipients: calcium phosphate dibasic anhydrous, guar gum, corn starch, gelatin, magnesium stearate, talc, sodium lauryl sulfate.

Description:

Tablets of 100 mg. White round flat tablets with bevelled edges, smooth on both sides.

Tablets 200 mg. White round biconvex tablets with a dividing notch on one side.

Tablets 400 mg. White round flat tablets with bevelled edges, with a dividing notch on one side.

Tablets 600 mg. White round flat tablets with bevelled edges, with a dividing notch on one side.

Tablets 800 mg. White capsule shaped tablets with a dividing notch on one side.

Tablets 1000 mg. White capsules in the form of capsules with a dividing notch on one side.

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 a violation of the synthesis of RNA in bacterial cells.

Affects intracellular and extracellular bacterial species. About 1% of patients have primary resistance to the drug. 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 penetrates well into various organs and biological fluids.The highest concentration is observed in the kidneys, lungs, saliva and urine.

It binds to plasma proteins by 20-30%. Ethambutol is metabolized in the liver to dicarboxylic acid derivatives. The half-excretion 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. Penetrates into breast milk. Does not pass through intact GEB.

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:

Inside, after breakfast.

Adults. Initial treatment period: 15 mg / kg body weight / day, once.Continuous treatment: usually 20 mg / kg of body weight / day, once.

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 prescribe from the calculation of 15-25 mg / kg body weight (but not more than 1.0 g per day), once.

The full course of treatment lasts 9 months.

With kidney disease, the dose of the drug depends on 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

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). Occurrence 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, disorder of orientation, hallucinations, convulsions, depression, peripheral neuritis.

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

Increased activity of "liver" transaminases.

Overdose:

Cases of ethambutol overdose have not been described.

Treatment in case of possible overdose: induce vomiting, carry out gastric lavage.

Interaction:

Etambutol is used in complex therapy with other anti-tuberculosis drugs: isoniazid, paraaminosalicylic acid, streptomycin, cycloserine, pyrazinamide, ethionamide and rifampicin.

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

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

Strengthens the neurotoxicity of aminoglycosides, asparaginase, carbamazepine, ciprofloxacin, imipenem, lithium salts, quinine.

Special instructions:

With monotherapy to ethambutol, the resistance of bacteria rapidly develops.

In patients who have previously taken drugs with tuberculostatic action, resistance 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 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 visual fields, color perception in relation to green and red), ethambutol should not be controlled by machines andto service moving mechanical equipment.

Form release / dosage:

Tablets, 100 mg, 200 mg, 400 mg, 600 mg, 800 mg or 1000 mg.

Packaging:

10 tablets per strip (aluminum / polyethylene). 10 strips, together with instructions for use, are placed in a cardboard box.

For 100 tablets in a plastic bag with subsequent insertion into a plastic container together with instructions for use.

Packing for hospitals: 1000 tablets in a plastic bag with subsequent insertion into a plastic container together with instructions for use.

Storage conditions:

In a dry, protected from light place at a temperature of no higher than 25 ° C.

Keep out of the reach of children.

Shelf life:

5 years.

Do not use after the expiry date printed on the package.

Terms of leave from pharmacies:On prescription

Registration number:P N 015660/01

Date of registration:25.05.2009

Expiration Date:Unlimited

The owner of the registration certificate:Lupine Co., Ltd.Lupine Co., Ltd. India

Manufacturer: & nbsp

LUPIN, Ltd. India

Representation: & nbspLUPIN LIMITEDLUPIN LIMITED

Information update date: & nbsp02.02.2018

Illustrated instructions

Instructions

Kombutol (Combutol)