Kombutol - Instructions For Use, The Price Of Tablets, Reviews, Analogues

2024 Author: Rachel Wainwright | [email protected]. Last modified: 2023-12-15 07:39

Kombutol

Kombutol: instructions for use and reviews

1. 1. Release form and composition
2. 2. Pharmacological properties
3. 3. Indications for use
4. 4. Contraindications
5. 5. Method of application and dosage
6. 6. Side effects
7. 7. Overdose
8. 8. Special instructions
9. 9. Application during pregnancy and lactation
10. 10. Use in childhood
11. 11. In case of impaired renal function
12. 12. Drug interactions
13. 13. Analogs
14. 14. Terms and conditions of storage
15. 15. Terms of dispensing from pharmacies
16. 16. Reviews
17. 17. Price in pharmacies

Latin name: Combutol

ATX code: J04AK02

Active ingredient: Ethambutol (Ethambutol)

Manufacturer: Lupine Limited (India)

Description and photo update: 2019-12-07

Kombutol is an anti-tuberculosis drug.

Release form and composition

The drug is available in the form of tablets: white; dosage 100 mg - round, flat, smooth on both sides, with beveled edges; dosage 200 mg - round, biconvex, with a dividing line on one side; dosage 400 and 600 mg - round, flat, with beveled edges and a dividing line on one side; dosage of 800 and 1000 mg - capsule, with a dividing line on one side (10 pcs. in aluminum or polyethylene strips, in a cardboard box 10 strips and instructions for use of Kombutol; 100 pcs. in plastic bags, in a plastic container 1 bag; for hospitals - 1000 pcs. in plastic bags, 1 bag in a plastic container).

1 tablet contains:

• active substance: ethambutol hydrochloride - 100, 200, 400, 600, 800 or 1000 mg;
• auxiliary components: guar gum, gelatin, corn starch, sodium lauryl sulfate, dibasic anhydrous calcium phosphate, magnesium stearate, talc.

Pharmacological properties

Pharmacodynamics

Kombutol is an anti-tuberculosis drug. Its active substance is ethambutol, which has a bacteriostatic effect against typical and atypical mycobacterium tuberculosis. The mechanism of action of the drug is due to the ability of ethambutol to disrupt the synthesis of RNA (ribonucleic acid) in bacterial cells.

Kombutol has an effect on intra- and extracellular bacterial species. It penetrates well into many tissues and organs. The degree of assimilation makes it possible to achieve a level of concentration of ethambutol in the lung tissue, 5-9 times higher than its content in the blood serum. In erythrocytes, the intracellular concentration of the drug is 2 times higher than in blood serum.

About 1% of patients show primary resistance to Kombutol.

Pharmacokinetics

After oral administration, ethambutol is rapidly absorbed from the digestive tract. The degree of absorption can reach 80% of the dose taken. The minimum inhibitory concentration is 1 mg / ml.

The maximum concentration of ethambutol in serum after taking a single dose at the rate of 25 mg per 1 kg of body weight (mg / kg) is reached after 2-4 hours and is 0.002-0.005 mg / ml, and after 24 hours the concentration level does not exceed 0.001 mg / ml.

Plasma protein binding - 20-30%.

It penetrates well into various biological fluids and organs. The highest concentration of ethambutol is noted in saliva, lungs, kidneys and urine. Penetrates through the placenta and into breast milk. In the blood of the fetus, the content of the active substance is about 30% of the level in the mother's blood. Does not cross the intact blood-brain barrier.

Ethambutol metabolism occurs in the liver with the formation of dicarboxylic acid derivatives.

The half-life (T _1/2) is 3-4 hours, with renal failure it increases to 8 hours.

During the first 24 hours through the kidneys, more than 50% of the dose taken is excreted unchanged and 8-15% in the form of inactive metabolites. About 20-22% of the dose is excreted through the intestines unchanged.

Indications for use

The use of Kombutol is indicated for the treatment of pulmonary and extrapulmonary tuberculosis.

Contraindications

• cataract;
• inflammation of the optic nerve;
• inflammatory eye diseases;
• diabetic retinopathy;
• gout;
• severe renal failure;
• period of pregnancy;
• breast-feeding;
• age up to 13 years;
• hypersensitivity to the components of Kombutol.

Kombutol, instructions for use: method and dosage

Kombutol tablets are taken orally, once a day after breakfast.

Recommended daily dosage:

• adults: the initial period of therapy - at the rate of 15 mg per 1 kg of the patient's body weight, continuous treatment - at 20 mg / kg. In the initial period of treatment, with a relapse of the disease or with resistance to other anti-tuberculosis drugs, an increase in the dose to 30 mg / kg is allowed if this does not exceed the maximum daily dose of 2000 mg;
• children over the age of 13: 15-25 mg / kg of body weight. The maximum daily dose is 1000 mg.

The duration of the full course of treatment is 9 months.

In case of kidney disease, a dose adjustment of Kombutol is required taking into account creatinine clearance (CC). For patients in this category, the following daily dosage is recommended:

• CC more than 100 ml / min: 20 mg / kg of body weight;
• CC 70–100 ml / min: 15 mg / kg of body weight;
• CC less than 70 ml / min: 10 mg / kg of body weight;
• with hemodialysis: 5 mg / kg body weight;
• on the day of dialysis: 7 mg / kg body weight.

Side effects

• on the part of the organ of vision: retrobulbar inflammation of the optic nerve, unilateral or bilateral (impaired color perception, weakening of visual acuity, limitation of the visual field, the presence of central or peripheral scotoma);
• from the digestive system: metallic taste in the mouth, abdominal pain, nausea, vomiting, lack of appetite, increased activity of liver transaminases;
• from the nervous system: confusion, headache, dizziness, hallucinations, disorientation, peripheral neuritis, convulsions, depression;
• allergic reactions: itching, rash, fever, joint pain, leukopenia;
• others: uric acid diathesis, increased serum uric acid levels.

Overdose

Symptoms of an overdose of Kombutol have not been established.

Treatment: if you accidentally take a high dose of ethambutol, you must immediately flush the stomach or induce artificial vomiting.

special instructions

When prescribing Kombutol, it should be borne in mind that against the background of its use as monotherapy, there is a rapid development of bacterial resistance to ethambutol. In addition, resistance develops more often in patients who have previously taken drugs with tuberculostatic action. Therefore, patients in this category are advised to combine ethambutol with such anti-tuberculosis drugs (one or two), to which they do not have bacterial resistance, and which the patient has not taken before.

Treatment with Kombutolm is recommended to be accompanied by periodic general blood tests, monitoring of kidney and liver function.

Before starting treatment, the patient must undergo an ophthalmological examination, including examination of the fundus, control of color perception, acuity and visual fields. Adverse events in the form of visual impairment are usually reversible. After discontinuation of the drug, they disappear after a few weeks, sometimes after a few months. In exceptional cases, transformations in the eyeball can be irreversible due to atrophy of the optic nerve. The likelihood of visual disturbances depends on the patient's eye pathologies and the duration of the course of treatment. If side effects from the visual system appear, ethambutol should be discontinued.

Influence on the ability to drive vehicles and complex mechanisms

During the period of use of Kombutol, patients are advised to refrain from driving vehicles and moving mechanical equipment. This is associated with an increased risk of the appearance of such visual impairments as decreased acuity and limitation of visual fields, changes in color perception.

Application during pregnancy and lactation

The use of Combutol tablets is contraindicated during gestation and lactation.

Pediatric use

Kombutol is contraindicated for the treatment of children under the age of 13.

With impaired renal function

In case of renal failure, the drug accumulates in the body, therefore, the dose of Kombutol must be reduced taking into account the CC in accordance with the dosage recommendations.

Drug interactions

The use of ethambutol as part of complex therapy with anti-tuberculosis drugs such as paraaminosalicylic acid, isoniazid, streptomycin, cycloserine, ethionamide, rifampicin, pyrazinamide is shown.

When taken simultaneously with aluminum hydroxide, the absorption of ethambutol decreases.

It should be borne in mind that ethambutol alters the metabolism of zinc and other trace elements, enhances the neurotoxicity of lithium salts, aminoglycosides, asparaginase, ciprofloxacin, imipenem, carbamazepine, quinine.

Analogs

Kombutol analogues are: Ekoks, EMB-Fatol 400, Li-butol, Etambusin, Ethambutol, Ethambutol-Acri, Ethambutol STADA.

Terms and conditions of storage

Keep out of the reach of children.

Store at temperatures up to 25 ° C, protected from moisture and light.

The shelf life is 5 years.

Terms of dispensing from pharmacies

Dispensed by prescription.

Reviews about Kombutol

There are no reviews about Kombutol.

Price for Kombutol in pharmacies

The price of Kombutol for a package containing 100 tablets with a dosage of 100 mg can be from 101 rubles, a dosage of 200 mg - from 108 rubles, a dosage of 400 mg - from 110 rubles, a dosage of 600 mg - from 228 rubles, a dosage of 800 mg - from 255 rubles, with a dosage of 1000 mg - from 338 rubles.

Maria Kulkes Medical journalist About the author

Education: First Moscow State Medical University named after I. M. Sechenov, specialty "General Medicine".

Information about the drug is generalized, provided for informational purposes only and does not replace the official instructions. Self-medication is hazardous to health!