Phyzoetam
Phtizoetam: instructions for use and reviews
- 1. Release form and composition
- 2. Pharmacological properties
- 3. Indications for use
- 4. Contraindications
- 5. Method of application and dosage
- 6. Side effects
- 7. Overdose
- 8. Special instructions
- 9. Application during pregnancy and lactation
- 10. Use in childhood
- 11. In case of impaired renal function
- 12. For violations of liver function
- 13. Drug interactions
- 14. Analogs
- 15. Terms and conditions of storage
- 16. Terms of dispensing from pharmacies
- 17. Reviews
- 18. Price in pharmacies
Latin name: Phthizoetham
ATX code: J04AM03
Active ingredient: ethambutol (ethambutol) + isoniazid (isoniazid)
Manufacturer: Akrikhin, JSC (Russia)
Description and photo update: 28.11.2018
Phthisoetam is an anti-tuberculosis drug.
Release form and composition
The drug is produced in the form of tablets: flat-cylindrical, from light yellow to yellow interspersed with yellow color of varying intensity (possibly the presence of white spots), with a risk and a chamfer (10 pcs. In blisters, in a cardboard box 5 or 10 packs; 50 or 100 pcs. in polyethylene or polypropylene cans, in a cardboard box 1 can; packing for hospitals - 500 or 1000 pcs. in containers; 100 pcs. in cans, 25 cans in a cardboard box; each pack also contains instructions for the use of Phthisoetam).
Composition of 1 tablet:
- active substances: ethambutol - 400 mg, isoniazid - 150 mg;
- auxiliary components: tropeolin O, povidone, calcium phosphate dihydrate, magnesium stearate.
Pharmacological properties
Pharmacodynamics
The action of Phthisoetam is determined by the substances included in its composition as active components.
Isoniazid is a specific anti-tuberculosis drug with a pronounced bactericidal effect, mainly against rapidly proliferating populations of mycobacterium tuberculosis. Suppresses the synthesis of mycolic acid, which is necessary for the formation of the cell wall of mycobacteria.
Ethambutol is a synthetic bacteriostatic agent that disrupts RNA synthesis in mycobacteria. Active only against rapidly proliferating populations of Mycobacterium tuberculosis. Ethambutol also prevents the development of strains resistant to rifampicin and isoniazid.
Pharmacokinetics
Isoniazid
Once in the gastrointestinal tract, it is absorbed quickly. Absorption and bioavailability of the substance are reduced with simultaneous ingestion of food.
With a single dose of 300 mg, C max in plasma is achieved within 1–2 hours.
No more than 10% of the substance binds to plasma proteins. The drug penetrates well into various fluids and tissues, including cerebrospinal fluid and bones.
It is metabolized in the liver by acetylation (mainly) and hydrolysis. The rate of acetylation depends on the individual characteristics of the patient. Metabolites have no antimicrobial activity.
T ½ can be 0.5-1.6 hours (in patients who are "fast acetylators") or 2-5 hours (in "slow acetylators"). In patients with existing functional disorders of the liver, this period increases.
Within 24 hours, 75–95% of the received dose of isoniazid is excreted in the urine from the body in the form of metabolites (N-acetylisoniazid, etc.), part of the substance is excreted unchanged: up to 12% - with rapid acetylation, up to 27% - with slow …
In patients with slow acetylation with severe renal failure, isoniazid may accumulate.
Ethambutol
After oral administration, bioavailability is 75–80%.
With a single dose of 25 mg / kg of body weight, the maximum concentration (C max) in plasma is reached within 2-4 hours.
It penetrates well into various body fluids and tissues, with the exception of cerebrospinal fluid. With tuberculous meningitis, 10–50% of the substance penetrates the pia mater.
Plasma proteins bind 20-30% of the drug.
The half-life (T ½) is 3-4 hours, in patients with renal insufficiency it increases to 8 hours.
Metabolized in the liver. About 15% of ethambutol is converted to metabolites that have no pharmacological activity.
Excreted: 80% - through the kidneys, 20% - through the gastrointestinal tract.
Indications for use
Phthisoetam is intended for the treatment of all forms and localizations of tuberculosis caused by mycobacteria sensitive to the isoniazid + ethambutol combination.
Contraindications
Absolute:
- epilepsy and other diseases with a tendency to seizures;
- uncontrolled arterial hypertension;
- severe coronary insufficiency;
- cataract;
- optic neuritis;
- diabetic retinopathy;
- acute gout;
- hyperuricemia;
- bronchial asthma;
- myxedema;
- psoriasis;
- stomach ulcer;
- acute hepatitis;
- cirrhosis of the liver;
- children under 12 years old;
- pregnancy and lactation;
- hypersensitivity to any component of the drug.
Relative (Phthisoetam should be used with caution):
- chronic renal failure;
- chronic alcoholism;
- impaired liver function;
- hypotrophy.
Phtizoetam, instructions for use: method and dosage
Phthisoetam tablets should be taken orally after meals, 1 time per day.
The dose of the drug is prescribed at the rate of 5-10 mg of isoniazid per kilogram of the patient's body weight.
During intensive anti-tuberculosis therapy (usually this period is 3-4 months), the drug is taken every day, then every other day.
The total dose of Phthisoetam for the course of treatment is individual and depends on the nature of the course of the disease, the tolerance of the drug and its effectiveness.
Side effects
Side effects that isoniazid can cause:
- allergic reactions: skin rashes, itching;
- from the gastrointestinal tract: abdominal pain, diarrhea, nausea, vomiting;
- from the hepatobiliary system: impaired liver function (especially in the elderly, patients with existing liver diseases and malnutrition);
- on the part of the cardiovascular system: a feeling of palpitations, increased blood pressure, angina pectoris;
- from the central nervous system: headache, dizziness; rarely - insomnia, irritability, psychosis, euphoria; in some cases - peripheral neuropathy (especially in the elderly, pregnant women, patients with chronic liver diseases, diabetes mellitus and malnutrition), increased frequency of seizures in patients with epilepsy;
- others: very rarely - menorrhagia, gynecomastia.
Side effects that ethambutol can cause:
- allergic reactions: itching, dermatitis, fever, arthralgia, anaphylaxis;
- from the nervous system: dizziness, headache, hallucinations, disorientation, blurred consciousness, weakness, paresis, peripheral neuritis (itching, tingling in the limbs, numbness);
- from the digestive system: decreased appetite, gastralgia, nausea, vomiting, increased activity of hepatic transaminases;
- from the senses: optic neuritis (scotoma, decreased visual acuity, color blindness);
- others: hyperuricemia.
Overdose
Symptoms: abdominal pain, nausea, vomiting, increased levels of liver enzymes, jaundice, hyperglycemia, metabolic ketoacidosis, seizures, impaired consciousness, coma, respiratory failure, acute pulmonary edema.
Treatment: gastric lavage, intake of activated charcoal, forced diuresis, hemodialysis, general measures to maintain vital functions.
special instructions
During treatment, liver function should be monitored monthly, including levels of liver enzymes (alanine aminotransferase and aspartate aminotransferase). Phthyzoetam is canceled if transaminase levels exceed the upper limit of the norm by more than 3 times. The drug must also be discontinued if acute or chronic hepatitis develops, it is prohibited to resume treatment in this case.
Some patients, especially those with a history of gout, may require monitoring of serum uric acid levels.
During the period of therapy, it is highly discouraged to consume alcohol.
Ethambutol can have a negative effect on the visual apparatus. In some cases, it may take a year or more to normalize vision. For this reason, it is necessary to periodically check visual acuity (both of both eyes together, and each separately). Patients should also be warned about the need for immediate medical attention in case of any change in visual acuity. If violations are found, Phtizoetam is canceled.
Against the background of anti-tuberculosis therapy, peripheral neuropathy may develop. For its prevention, an additional intake of pyridoxine (vitamin B 6) is recommended.
Influence on the ability to drive vehicles and complex mechanisms
In high doses, Phthisoetam can cause unwanted reactions from the nervous system, which negatively affects a person's ability to perform potentially hazardous activities, including driving.
Application during pregnancy and lactation
During pregnancy, Phyzoetam tablets are contraindicated. He can be prescribed by a doctor only in exceptional cases.
If anti-TB therapy is necessary during lactation, breastfeeding should be discontinued.
Pediatric use
This drug is not used to treat tuberculosis in children under 12 years of age.
With impaired renal function
Phthisoetam is used with caution in patients with chronic renal failure. A dose reduction may be required.
For violations of liver function
The drug has a hepatotoxic effect, therefore, it is used with caution in the presence of concomitant hepatic dysfunction or chronic alcoholism.
Phthyzoetam is contraindicated in liver cirrhosis and acute hepatitis.
Drug interactions
Possible interactions of isoniazid with other drugs:
- phenytoin, valproate, carbamazepine and some other drugs: their metabolism slows down, which requires a dose reduction;
- disulfiram: development of mental disorders is possible (this combination is recommended to be avoided);
- carbamazepine, phenytoin: their serum concentrations increase;
- ketoconazole, cyclosporine: their concentration in the blood decreases;
- antacids: absorption of isoniazid decreases;
- glipizide, tolazamide, theophylline, tolbutamide, oral contraceptives: their effectiveness decreases;
- phenytoin: its side effects increase;
- triazolam: its excretion is suppressed;
- vitamin B 1: its excretion increases, the effect decreases;
- zinc preparations: the content of zinc ions in the blood decreases, their excretion increases;
- ethanol: increases the risk of developing hepatitis.
With the simultaneous use of ethambutol and drugs with neurotoxic effects, the likelihood of developing peripheral neuritis increases.
Analogs
Phthisoetam analogs are: Iso-Eremfat, Izosid comp., Isocomb, Izopask, Kombitub, Laslonvita, Levofloripin, Lomecomb, Mak-Pas plus, Protiokomb, Protub-2, Protub-3, Protub-4, Protub-4 plus, Protub- 5, Protub-Lome, Protubvita, Protubpira, Protubetam, Ripeg, Rifakomb, Tubavit, Forkoks, Phtzamax, Phtzopyram, etc.
Terms and conditions of storage
Store at a temperature not exceeding 25 ° C in a dry and dark place out of the reach of children.
The shelf life is 3 years.
Terms of dispensing from pharmacies
Dispensed by prescription.
Reviews about Phtizoetam
Patients leave mostly positive reviews about Phthisoetam as an effective anti-tuberculosis drug. Its disadvantages include the frequent development of side effects and the frequent absence in free sale.
Price for Phthisoetam in pharmacies
The approximate price for Phthisoetam is 8700 rubles. per pack of 100 tablets.
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!
