Iso-Eremfat - instructions for use, doses, side effects, contraindications

Active substanceIsoniazid + RifampicinIsoniazid + Rifampicin

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Iso-Eremfat

pills inwards

Rimzer Artsynaimitel, AG Germany

Dosage form: & nbspcoated tablets

Composition:

One tablet contains:

Active substances:

Rifampicin ......... 150 mg .... 300 mg

Isoniazid ............. 100 mg ... 150 mg

Excipients: core: microcrystalline cellulose, croscarmellose sodium, crospovidone, colloidal silicon dioxide, talc, magnesium stearate, hypromellose (hydroxypropylmethylcellulose); shell: hypromellose (hydroxypropylmethylcellulose), titanium dioxide, iron oxide (3), macrogol 6000.

Description:For a dosage of 100 mg / 150 mg: red-brown round biconvex film-coated tablets. Color at the break - red-brown.

For a dosage of 150 mg / 300 mg: red-brown round biconvex film-coated tablets with a notch for a fault on one side. Color at the break-red-brown.

Pharmacotherapeutic group:Anti-tuberculosis drug

ATX: & nbsp

J.04.A.M.02 Isoniazid in combination with rifampicin

Pharmacodynamics:

IZO-EREMPHAT contains a combination of two anti-tuberculosis drugs - rifampicin and isoniazid.

Rifampicin and isoniazid have the greatest activity in relation to rapidly growing extracellularly located microorganisms, but also has a bactericidal effect on intracellularly located pathogens.

Rifampicin

Rifampicin is also active against slowly and intermittently growing forms of Mycobacterium tuberculosis. The mechanism of action of rifampicin is the inhibition of DNA-dependent RNA polymerase. With tuberculosis rifampicin has a bactericidal effect on both intracellular and extracellular microorganisms.

Isoniazid

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 Mycobacterium tuberculosis, the minimum inhibitory concentration (MIC) of isoniazid is 0.05-0.025 mg / L. Resistance to isoniazid arises quickly.

Pharmacokinetics:

After taking IZO-EREMPHAT inside, its active components are quickly and completely absorbed from the digestive tract. The maximum concentration of active components in plasma is reached by the second hour and remains at a detectable level up to 8 hours.

Rifampicin

In case of reception together with food, the absorption of rifampicin, which is part of IZO-EREMPHAT, is reduced by 30%.

The maximum concentration of rifampicin in plasma is reached after 2 hours. Rifampicin widely distributed in the body. Approximately 80% of the dose is associated with plasma proteins. Rifampicin metabolizes in the liver to deacetyltrifampicin, this metabolite is active. Rifampicin is excreted from the body with urine (up to 30% of the dose taken).

Isoniazid

After receiving IZO-EREMPHAT in healthy adults, the peak concentration of Isoniazid in plasma reaches 2 hours. The half-life of isoniazid from the plasma is 2-6 hours. Isoniazid is subjected to a pronounced pre-systemic metabolism in the wall of the small intestine and liver, as a result of which its plasma concentration in patients with a fast acetylation process is half the concentration in patients with a slow acetylation process. Up to 95% of the dose of isoniazid is excreted in the urine in the first 24 hours. Less. 10% of the dose is excreted with feces.

The main products of urinary excretion are N-acetylisosodium and isonicotinic acid.

Indications:ISO-EREMPHATE is indicated for the treatment of the initial stage of pulmonary tuberculosis. It is also shown in the initial stages of extrapulmonary tuberculosis.

Contraindications:

IZO-EREMPHAT is contraindicated:

-when hypersensitivity to any ingredient of this drug,

- Epilepsy and a tendency to convulsive seizures, in the case of a previous history of poliomyelitis,

-If a violation of the liver and kidneys, gout,

thrombophlebitis, severe atherosclerosis,

-If pregnancy and lactation,

children under 12 years;

patients with a body weight of less than 45 kg.

Carefully:

With care appoint IZO-EREMFAT to patients with liver diseases, elderly and emaciated patients, as well as patients suffering from chronic alcoholism.

Pregnancy and lactation:IZO-EREMPHATE can not be used in the first trimester of pregnancy and also with breastfeeding. The possibility of using IZO-EREMPHAT during further pregnancy can be solved only by a doctor after assessing the degree of risk / effect. When used in the last weeks of pregnancy, Iso-EREMPHAT can cause postpartum bleeding in the mother or newborn, for which vitamin K is used.

Dosing and Administration:

The drug is prescribed to adults. The daily dose is set taking into account the patient's body weight. It is possible to use the following schemes of prescribing the drug in the continuation phase.(The initial phase involves the administration of Iso-eremfata + streptomycin / ethambutol for 2 months).

Short course of treatment:

The continuation phase (4 months or more): appointed isoniazid and rifampicin (ISO-EREMPHATE) every day or 2-3 times a week.

Therapy of tuberculosis should last for 6 months - and at least 3 more months after the termination of bacterial release.

Long course of treatment:

Patients with resistance or extrapulmonary forms of tuberculosis may require a longer course of therapy (continuation phase).

In the case of HIV infection, treatment should be continued for 9 months and at least 6 months after stopping the bacterial release. Each film-coated tablet containing: Rifampicin 150 mg Isoniazid 100 mg is taken orally for 1 to 2 hours before meals, 4 tablets per day, single patients whose body weight does not exceed 50 kg, for two months. Each film-coated tablet contains:

Rifampicin 300mg

Isoniazid 150mg

is taken orally 1-2 hours before meals, 2 tablets per day, single patients with a body weight of at least 60 kg, for two months.It is possible to use the drug in combination with other anti-tuberculosis drugs, such as streptomycin, etc.

It is recommended simultaneous administration of pyridoxine to elderly patients, persons with a predisposition to neuropathy (patients with diabetes mellitus).

Side effects:

The side effects of IZO-EREMPHAT are determined by the active ingredients in the formulation.

Rifampicin

Rifampicin can cause side effects from the gastrointestinal tract, such as heartburn, epigastric discomfort, anorexia, vomiting, intestinal colic and diarrhea. Some patients experience headache, drowsiness, weakness, ataxia, dizziness, confusion, visual disorders, muscle weakness, fever, pain in the extremities, itching, urticaria, skin rashes and ebbinophilia, sore throat and soreness of the tongue. Men occasionally experience toxic liver damage, which usually develops in the first two weeks after the start of treatment.

Isoniazid

Long-term use of isoniazid causes periphyrical neuropathy in 3.5-17% of patients.There is a feeling of tingling and numbness in the fingers and toes, some patients have muscle weakness, headache, dizziness, nausea, vomiting, drug-induced hepatitis, gynecomastia in men and menorrhagia in women. Prophylactic and therapeutic use of isoniazid in the form of monotherapy or in combination with anti-tuberculosis drugs is associated with a significant risk of toxic damage to the liver.

Interaction:

Rifampicin

It is known that rifampicin induces some enzymes of the cytochrome P-450 system. Determined that rifampicin accelerates the metabolism of phenytoin, hnnidine, oral anticoagulants and antifungal drugs.

Isoniazid

Phenytoin. Isoniazid enhances the effects of phenytoin, such as drowsiness and ataxia.

Prednisolone can significantly reduce the concentration of isoniazid in blood plasma in slow and fast acetylators, but this effect is more pronounced in slow acetylators.

Special instructions:

During treatment with IZO-EREMPHAT it is necessary to monitor the state of kidneys, liver and blood.

When prescribing IZO-EREMPHAT, it should be borne in mind that urine, feces, saliva and tears can be colored orange.

Form release / dosage:

Film-coated tablets containing 100 mg of isoniazid and 150 mg of rifampicin or 150 mg of isoniazid and 300 mg of rifampicin.

Packaging:

For 100 tablets in a container of white color from polypropylene with a white lid of low density polyethylene with a ring of the first opening, the empty space is filled with foam rubber sealant, a label is attached to the container. A container of 100 tablets together with the instruction for use is placed in a cardboard box.

For 10 tablets in PVC / acrylic / PVC-aluminum blister. For 5, 10, 100 blisters in a cardboard box together with instructions for use. On a pack of 1000 tablets (for hospitals) stick a label.

For 1000 tablets in a brown PVC container with a protective membrane of low pressure polyethylene and a screw cap of black color from Bakelite with a PVC substrate, the free space is filled foam rubber sealant, on top of which is placed instructions for use, a label is attached to the container. At 10, 18,20,30, 40 containers (1000 tablets) are placed in a group package-a cardboard box (for hospitals).

Storage conditions:

List B.

Store at a temperature not exceeding + 25 ° С.

Protect from moisture and light.

Keep out of the reach of children.

Shelf life:3 years. After the expiration date, the drug can not be used.

Terms of leave from pharmacies:On prescription

Registration number:П N015081 / 01

Date of registration:21.05.2009 / 19.12.2012

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: & nbsp23.10.2017

Illustrated instructions

Instructions

Iso-Eremfat (Iso-Eremfat)