Phthisotam B6 - instructions for use, dose, side effects, contraindications

Active substanceIsoniazid + Etambutol + PyridoxineIsoniazid + Etambutol + Pyridoxine

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Phthisoetham B6

pills inwards

AKRIKHIN HFK, JSC Russia

Dosage form: & nbsppills

Composition:

1 tablet contains

active substances: isoniazid - 150 mg, ethambutol hydrochloride - 400 mg, pyridoxine hydrochloride - 15 mg

Excipients: calcium phosphate dihydrate, povidone, crospovidone, magnesium stearate.

Description:tablets white with a yellowish or kremovatym color shade, flat-cylindrical, with a facet and a risk. Presence of "marble" is admissible.

Pharmacotherapeutic group:Anti-tuberculosis drug combined

ATX: & nbsp

J.04.A.M.03 Isoniazid in combination with ethambutol

Pharmacodynamics:

Isoniazid has a bactericidal effect on the actively dividing cells of Mycobacterium tuberculosis. The mechanism of its action is the inhibition of the synthesis of mycolic acids, which are a component of the cell wall of mycobacteria. For mycobacteria tuberculosis, the minimum inhibitory concentration (MIC) is 0.025-0.05 mg / l. Isoniazid has a moderate effect on slowly - and rapidly growing atypical mycobacteria.

Ethambutol

Etambutol is a bacteriostatic drug that is effective against 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, it suppresses the synthesis of the cell wall,blocking the inclusion of mycolic acids in it. Ethambutol Active against rapidly and slowly growing atypical mycobacteria. The MIC of ethambutol is - 0,78-2,0 mg / l. On non-tubercular pathogens ethambutol It does not work.

Pyridoxine hydrochloride

Vitamin product. Participates in the metabolism. It is necessary for the normal functioning of the central and peripheral nervous system. Anti-TB drugs cause peripheral polyneuropathy, the occurrence of which can reduce pyridoxine. In this regard, the daily dose of vitamin increases to 60 mg. With the simultaneous administration of pyridoxine inwards with isoniazid and ethambutol, there is no interaction of these drugs at the pharmacokinetic and microbiological levels.

Pharmacokinetics:

Isoniazid

Taking isoniazid in together with the drugs that are part of phthizoetham B6, does not affect the rate of its absorption from the gastrointestinal tract (GIT). Penetrates isoniazid in many tissues and body fluids, including cerebrospinal fluid (CSF). The time to reach the maximum concentration of the drug in the blood (TCmax) is 2 hours, the value of Cmax is 6.6 mg / L, the half-life (T1 / 2> -5.8 hours. Isoniazid acetylated and hydrolyzed in the liver.Acetylation is the main pathway of isoniazid metabolism. The rate of acetylation depends on the individual characteristics of the patient. Metabolites of isoniazid do not have antimicrobial activity.

Within 24 hours with urine, 75-95% of the administered dose in the form of metabolites (N-acetylisoiniazide, etc.) is excreted. Part of isoniazid is excreted in the urine in a modified form: up to 12% with rapid acetylation and up to 27% with slow acetylation. With severe renal failure in patients with slow acetylation, accumulation of the drug is possible.

Ethambutol

After taking Phtysoetham ® B6 Cmax ethambutol reaches 6.4 - 7.6 mg / l. High ethambutol Cmax is explained by the slowing of its excretion under the influence of isoniazid. Stam preparation in plasma (60%) is achieved after 2 hours. Ethambutol Excreted in urine 70% unchanged; 30% in the form of aldehyde and carboxyl inactive metabolites. On average, 25% of the drug binds to plasma proteins.

Pyridoxine hydrochloride

Absorbed rapidly throughout the small intestine, a larger amount is absorbed in the jejunum. Metabolised in the liver with the formation of pharmacologically active metabolites (pyridoxal phosphate and pyridoxamine phosphate). Pyridoxal phosphate with plasma proteins binds to 90%.Well penetrate into all tissues; accumulates mainly in the liver, less - in the muscles and central nervous system (CNS).

Penetrates through the placenta, is secreted with breast milk. Tu2 - 15-20 days. It is excreted by the kidneys.

Indications:Phthisotam® B6 is indicated for the treatment of all forms and locations of tuberculosis caused by susceptible mycobacteria to isoniazid and ethambutol. Phthisotam® B6 can be used for chemoprophylaxis of tuberculosis and for conducting anti-relapse therapy.

Contraindications:

Phthisotam®B6 is contraindicated in children under 12 years of age, in patients with hypersensitivity to isoniazid, ethambutol and pyridoxine. Contraindicated in epilepsy and other diseases accompanied by a tendency to convulsions, uncontrolled arterial hypertension, severe coronary insufficiency, cirrhosis of the liver, acute hepatitis, myxedema, optic neuritis, cataract, diabetic retinopathy, bronchial asthma, psoriasis, hyperuricemia, acute gout, peptic ulcer disease stomach and duodenum, pregnancy, lactation.

Carefully:With caution, prescribe the drug to people with chronic kidney failure.

Pregnancy and lactation:Contraindicated

Dosing and Administration:The drug Phthisotam®B6 is administered orally after meals, once a day. Dosage of phthisoetham®B6 is carried out by isoniazid: for adults and children over 12 years of age 5-10 mg / kg of body weight. The drug is used daily in the intensive care period (3-4 months), in the subsequent time - every other day. The total course dose of Phthisoetham® B6 for each individual and depends on the nature of the disease, the effectiveness of treatment and tolerability.

Side effects:

Isoniazid

From the side of the nervous system: headache, dizziness, rarely unusual fatigability or weakness, irritability, euphoria, insomnia, paresthesia, numbness of limbs, peripheral neuropathy, optic neuritis, polyneuritis, psychosis, mood change, depression. Seizures can occur in patients with epilepsy.

From the cardiovascular system (CCC): palpitation, increased blood pressure (BP), angina.

On the part of the digestive system: nausea, vomiting, gastralgia, toxic hepatitis.

Allergic reactions: skin rash, itching, hyperthermia, arthralgia.

Other: very rare - ginekomastia, menorrhagia, a tendency to bleeding and hemorrhage.

Ethambutol

From the side of the nervous system and sensory organs: weakness, headache, dizziness, impaired consciousness, disorientation, hallucination, depression, peripheral neuritis (paresthesia in the limbs, numbness, paresis, itching), optic neuritis (decreased visual acuity, mostly green and red flowers, color blindness, scotoma).

On the part of the digestive system: decreased appetite, gastralgia, nausea, vomiting, impaired liver function - increased activity of "liver" transaminases.

Allergic reactions: dermatitis, skin rash, itching, arthralgia, fever, anaphylaxis.

Other: hyperuricemia, exacerbation of gout.

Pyridoxine hydrochloride

Allergic reactions, hypersecretion of hydrochloric acid, numbness, the appearance of a feeling of compression in the limbs - a symptom of "stocking" and "gloves", rarely - a skin rash, itching of the skin.

Overdose:

Symptoms of overdose: nausea, vomiting, abdominal pain, jaundice, increased liver enzymes, acute pulmonary edema, impaired consciousness, coma, convulsions, respiratory failure, hyperglycemia, metabolic ketoacidosis.

Treatment: gastric lavage with the introduction of activated carbon, forced diuresis, general measures to maintain vital functions, hemodialysis.

Interaction:

Isoniazid

Isoniazid slows the metabolism of certain medicines, including phenytoin, carbamazepine, valproat. At a simultaneous appointment with isoniazid dose of these drugs is recommended to reduce.

It is necessary to avoid the simultaneous use of isoniazid and disulfiram, since this can lead to mental disorders. The mechanism of this interaction is not established.

Isoniazid increases the serum concentrations of carbamazepine and phenytoin, reduces the concentration of ketoconazole and cyclosporine in the blood.

Antacids reduce the absorption of isoniazid.

Reduces the effectiveness of oral contraceptives, glipizide, tolbutamide, theophylline, tolazomide, vitamin Bb increases the side effects of phenytoin; suppresses the excretion of triazolam, enhances the excretion of vitamin Bb, reduces the content of zinc ions in the blood, increases their excretion.

Drinking alcohol with isoniazid therapy can increase the risk of hepatitis.

Ethambutol

Simultaneous administration of ethambutol and drugs that have a neurotoxic effect may increase the likelihood of developing the optic nerve and peripheral neuritis.

Pyridoxine hydrochloride

Pyridoxine hydrochloride weakens the action levodopa with their joint application. Pyridoxine hydrochloride reduces the risk of toxic effects of antituberculosis drugs on the central and peripheral nervous system.

Special instructions:

During treatment with the drug, patients should refrain from drinking alcohol.

In some cases, especially in patients with a history of gout, it is recommended to periodically monitor the level of uric acid in the serum.

Etambutol can have a negative effect on vision. Vision usually normalizes after the timely abolition of ethambutol. In rare cases, the normalization of vision can occur within a year or more. It is necessary to check the visual acuity of each eye individually and both eyes together; Visual acuity is checked before treatment and periodically during treatment. With any change in visual acuity, patients should immediately consult a doctor.If there is a decrease in visual acuity, the drug is canceled.

It is recommended to monitor ALT and ACT levels in plasma and monthly to assess liver function. Isoniazid should be abolished only in cases where the levels of transaminases are more than 3 times higher than the upper limit of the norm, since an asymptomatic transient increase in the level of hepatic enzymes that does not require discontinuation of the drug is often observed. With the development of acute or chronic hepatitis the drug must be canceled, in the latter case, it is impossible to resume therapy with the drug.

Effect on the ability to drive transp. cf. and fur:It is not recommended to drive and work with complex equipment.

Form release / dosage:Pills.

Packaging:

For 50 or 100 tablets in a can of polyethylene or in a can of polypropylene. Each bank along with the instruction for use is placed in a pack of cardboard. For 500 or 1000 tablets per package of polyethylene film; a polyethylene bag together with instructions for use in a container made of polyethylene or polypropylene (for inpatient).

For 25 cans of 100 tablets, together with an equal number of instructions for use are placed in a box of cardboard (for inpatient).

Storage conditions:List B. In a dry, the dark place at a temperature of no higher than 25 ° C. Keep out of reach of children.

Shelf life:2 years. Do not use after the expiry date printed on the package.

Terms of leave from pharmacies:On prescription

Registration number:LS-002335

Date of registration:26.12.2011

The owner of the registration certificate:AKRIKHIN HFK, JSC AKRIKHIN HFK, JSC Russia

Manufacturer: & nbsp

AKRIKHIN HFK, JSC Russia

Information update date: & nbsp11.09.2012

Illustrated instructions

Instructions

Phthisoetham B6 (Phtizoethamum B6)