R-Cinex

R-CINEX is a combination drug that contains components that have an active anti-tuberculosis effect:

• Rifampicin is a bactericidal antibiotic that inhibits RNA synthesis;
• Pyridoxine hydrochloride (one of the forms of vitamin B) – plays a significant role in metabolism, affects the processes of hematopoiesis, normalizes the functions of the human nervous system;
• Isoniazid is a substance that inhibits the synthesis of mycolic acids, components of the cell wall of mycobacteria.
• Excipients (in suspension): ascorbic acid, sodium chloride, sodium metabisulfite, sodium saccharin, propylene glycol, sorbitol, liquid flavors, purified water, etc.

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Indications R-Cinex

Indications for use of R-Cinex are all forms of tuberculosis (pulmonary and extrapulmonary), as well as non-specific infectious diseases caused by sensitive microorganisms ( pyelonephritis, pneumonia, osteomyelitis ); the presence of meningococci in the nasopharynx of carriers.

Anti-tuberculosis agents include drugs intended for the prevention and effective treatment of tuberculosis. Their therapeutic effect is primarily associated with bacteriostatic action. R-Cinex should be combined with some other anti-tuberculosis agent due to the possibility of tuberculosis pathogens developing resistance to rifampicin.

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Release form

R-Cinex is available as a suspension for oral use, capsules containing rifampicin (0.45 g) and isoniazid (0.3 g), and film-coated tablets (R-CINEX Z: Rifampicin + Isoniazid + Pyrazinamide).

The release form of the drug in different variants makes it possible to choose the best one, depending on the patient's condition and the characteristics of the disease.

R-Cinex capsules are available in 80 pieces per package: 450 mg rifampicin + 300 mg isoniazid. Suspension - 100 ml of the drug in vials.

R-CINEX Z tablets contain 0.225 g rifampicin, 0.15 g isoniazid and 0.75 g pyrazinamide.

When taking R-Cinex in any form, it is necessary to take into account that rifampicin tends to color body fluids (urine, sweat, tears), as well as contact lenses, feces and skin in an orange-red hue. Long-term use of the drug requires systematic monitoring of liver function (at least once a month), observation by an ophthalmologist and monitoring of the peripheral blood picture.

If persistent liver dysfunction develops, treatment with R-Cinex should be interrupted and resumed only after laboratory and clinical parameters have clearly returned to normal.

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Pharmacodynamics

R-Cinex is a combination drug, the main active ingredient of which is rifampicin (a derivative of rifamycin) – a semi-synthetic antibiotic with a pronounced bactericidal effect.

The pharmacodynamics of R-Cinex is based on the combination of medicinal substances included in the preparation and their mechanisms of action. The main effect is the suppressive action of rifampicin on the synthesis of bacterial RNA, as well as gram-negative and gram-positive microorganisms: Mycobacterium tuberculosis, N. Meningitides, Mycobacterium leprae, Streptococcus spp., Staphilococcus spp., Bacillus anthracis, Pseudomonas, E. coli, Proteus and Klebsiella, Brucella spp., Salmonella typhi, Legionella pneumophila, etc.

Isoniazid, which is part of R-Zynex, has found wide application as an anti-tuberculosis agent. This representative of isonicotinic acid derivatives is characterized by effective bacteriological activity against mycobacteria ‒ tuberculosis pathogens. This drug is used in medicine to treat active tuberculosis in both adults and children. It is especially effective in early, acute processes of the disease. In combination with rifampicin, isoniazid produces a pronounced therapeutic effect.

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Pharmacokinetics

R-Cinex contains components that easily penetrate the body and begin their active therapeutic effect within a couple of hours after taking the drug.

Pharmacokinetics of R-Cinex: the main active substance, rifampicin, is easily absorbed from the gastrointestinal tract and quickly distributed throughout all fluids, tissues, and bones of the human body. The only thing is that its absorption is somewhat reduced when taken with food. In blood plasma, the maximum concentration of the substance is reached after 2-3 hours.

The greater amount of rifampicin (60-80%) is metabolized in the liver, the rest - in the intestinal walls (30-45%), where active metabolites of formylrifampin and deacetylrifampin are formed, retaining their anti-tuberculosis activity. The half-life of R-Cinex is 1.5-5 hours. The drug is excreted by the liver (up to 60%) and with urine (up to 30%).

As for pyridoxine, its absorption from the gastrointestinal tract occurs just as easily and quickly. The main metabolism of this substance occurs in the liver. The half-life of pyridoxine is quite long and is 15-20 days. The substance is excreted through the kidneys (about 60%) and through bile (up to 2% of the dose).

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Dosing and administration

R-Cinex must be taken strictly according to the regimen prescribed by the attending physician, based on laboratory blood parameters, the presence of chronic diseases in the patient and other factors that may cause side effects of the drug or prohibit its use.

Method of administration and dosage: the drug is usually prescribed orally, 1 tablet (capsule) per day throughout the entire therapeutic course. Adults should take R-Cinex based on their body weight: if it is less than 50 kg, 450 mg, if more than 50 kg, up to 600 mg (this is the maximum). Children are prescribed the drug in a dosage of 10 to 15 mg per day. In chronic renal failure, the indicator is 8 mg of the drug/kg.

It is necessary to remember the need for systematic monitoring of liver function during prolonged use of R-Cinex, as well as monitoring of the peripheral blood picture and ophthalmological control. It is not recommended to carry out microbiological tests to determine the concentration of vitamin B12 in the blood serum, as well as folic acid. Taking R-Cinex requires the patient to refrain from taking ethanol.

The development of persistent liver dysfunction in a patient requires immediate interruption of treatment with R-Cinex. Resumption of therapy is possible only after normalization of indicators - both clinical and laboratory.

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Use R-Cinex during pregnancy

R-Cinex can be used to treat tuberculosis in pregnant women, however, following the instructions, before starting treatment, you should weigh all the pros and cons of such therapy, assessing its expected benefits for the mother and all possible risks for the baby. Only under this condition should you allow taking the drug.

The use of R-Cinex during pregnancy should be carried out under the strict supervision of the attending physician, only in extreme cases, if alternative treatment is ineffective and does not give positive results. According to medical research, the use of this anti-tuberculosis drug in the last weeks of pregnancy can increase the risk of bleeding - both in newborns and in mothers (in the postpartum period). This is a significant factor that should be taken into account when choosing R-Cinex as a therapeutic drug.

Considering the penetration of rifampicin into various fluids and tissues of the human body, it is easy to assume that it is excreted with breast milk. Therefore, when using this drug during lactation, the mother will need to stop breastfeeding the newborn.

Contraindications

R-Cinex, like any other medication with a bactericidal effect, has a number of contraindications that must be taken into account before starting treatment.

Contraindications for the drug R-Cinex, as well as conditions in which it should be used with caution:

• hypersensitivity to the components contained in the drug;
• pregnancy (first trimester);
• pregnancy (second and third trimesters);
• breastfeeding period;
• liver failure;
• various liver diseases (including history);
• children under 12 years of age;
• old age;
• chronic renal failure;
• chronic alcoholism;
• general weakness of the body.

In addition to the above conditions, under which taking R-Cinex is undesirable, it is necessary to take into account the presence of such diseases in the patient as hyperuricemia (increased levels of uric acid in the blood), purpura (a disease whose main feature is a tendency to bleeding), gout (a disease of the joints caused by the deposition of uric acid in them). Taking R-Cinex is also not recommended for pulmonary heart failure of II-III degree, as well as for acute liver diseases, including jaundice.

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Side effects R-Cinex

R-Cinex has a number of side effects that must be taken into account when treating with this anti-tuberculosis drug.

Side effects of R-Cinex are observed both from the nervous system and the urinary, digestive, cardiovascular systems. In addition, allergic reactions and other disorders may occur when taking the drug. Among the most common side effects of R-Cinex, the following should be noted:

• headache;
• loss of appetite;
• diarrhea;
• nausea and vomiting;
• gastritis and enterocolitis;
• allergic manifestations (urticaria, fever, bronchospasm, arthralgia);
• loss of visual acuity;
• dysmenorrhea;
• exacerbation of gout.

In addition to the above-mentioned side effects of R-Cinex, there are others: hepatitis, nephronecrosis, disorientation, leukopenia, hyperuricemia, myasthenia, etc. Irregular intake or resumption of treatment with R-Cinex can provoke a flu-like syndrome, the symptoms of which are chills, headache and dizziness, weakness, fever, myalgia. Complications in the form of skin reactions, the occurrence of acute renal failure, and hemolytic anemia are possible.

Isoniazid, which is part of the drug R-Cinex, can cause excessive fatigue and weakness, or euphoria, irritability, insomnia, as well as paresthesia, psychosis, polyneuritis, peripheral neuropathy, depression. From the side of the cardiovascular system, failures in the form of angina pectoris, rapid heartbeat, increased blood pressure can occur. Among the rare side effects, it is necessary to note gynecomastia, menorrhagia, as well as the body's tendency to hemorrhages and bleeding.

More detailed information about all types of side effects of R-Cinex can be found in the instructions for this medication.

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Overdose

R-Cinex must be taken without exceeding the dosages specified in the instructions or the doctor's treatment regimen. This is a very important condition, since an overdose of the drug can cause serious and even life-threatening complications in the patient.

An overdose of the anti-tuberculosis drug R-Cinex causes a number of adverse symptoms and conditions caused by an excessive amount (excess) of the active substances of the drug.

Thus, an overdose of rifampicin can lead to:

• pulmonary edema,
• the occurrence of convulsions,
• the appearance of confusion,
• lethargy (a pathological condition characterized by loss of consciousness, loss of motor abilities and deep, prolonged sleep).

If such symptoms of overdose are observed, symptomatic treatment must be carried out: prescribe gastric lavage, sorbent intake, and forced diuresis (a method of detoxification in emergency therapy).

If you overdose on isoniazid, the following symptoms may occur:

• lethargy and dizziness,
• disorientation (disorientation) and confusion,
• hyperreflexia (increased reflexes),
• dysarthria (speech disorder),
• metabolic acidosis (disturbance of the acid-base balance in the body),
• peripheral polyneuropathy (peripheral nerve disease),
• liver dysfunction,
• hyperglycemia (increased blood sugar levels),
• convulsions (usually occur a couple of hours after taking R-Zinex),
• coma.

If the patient develops peripheral polyneuropathy, B vitamins (B12, B6, B1) are prescribed, as well as glutamic acid, nicotinamide, ATP, various physiotherapeutic procedures and massage. If the patient develops seizures, it is necessary to use complex treatment: vitamin B6 (200-250 mg intramuscularly), 25% magnesium sulfate solution (10 ml intramuscularly), as well as 40% dextrose solution (20 ml intravenously) and diazepam. In case of liver dysfunction, drugs such as vitamin B12, ATP, methionine and lipamide are usually prescribed.

Interactions with other drugs

R-Cinex is compatible with almost all anti-tuberculosis drugs, except cycloserine. The side effects of this medicine can be reduced by combining R-Cinex with pyridoxine and glutamic acid.

Interactions of R-Cinex with other drugs:

• R-Cinex can reduce the effect of hormonal contraceptives, oral anticoagulants, quinidine, ketoconazole, digitalis preparations, hypoglycemic and antiarrhythmic drugs, as well as other medications (see the instructions for R-Cinex for more details);
• by means of rifampicin the parameters of bromsulfalein excretion are changed (the rate of the process increases);
• Anticholinergic drugs, opiates and antacids, ketoconazole contribute to a decrease in the bioavailability of rifampicin;
• the combination of rifampicin with isoniazid and/or pyrazinamide aggravates liver dysfunction in patients with a history of liver disease;
• PAS (para-aminosalicylic acid) preparations, which contain bentonite, are prescribed 4 hours after taking R-Cynex;
• Isoniazid can increase the concentration of phenytoin (an antiepileptic drug) in the blood.

Any combination of R-Cinex with other drugs should be carried out exclusively under the supervision of the attending physician.

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Storage conditions

R-Cinex should be stored in a dark place protected from direct sunlight. The temperature should not exceed 25°C (this information is provided in the instructions for the drug).

The storage conditions for R-Cinex are almost the same as for other medicines: keep out of reach of children, maintain optimal temperature balance and dryness. It should be remembered that expired medicine should be thrown away, even if it is not used up completely.

Tablets and capsules are “afraid” of humidity, so storing them in the bathroom, kitchen, balcony or other humid environment is strictly not recommended. The best option would be a bedroom or any other room with a lockable cabinet or chest of drawers. It is better to store medications in a box with a tight lid, on the top shelves of the cabinet, where children cannot get them. All bottles and blisters must be stored closed, in the original packaging.

R-Cinex tablets and capsules should be removed from the blisters immediately before use. This is due to the hygroscopicity of solid dosage forms. Protecting any medicine from the sun means protecting it from heating, which in turn can affect the composition of the drug and even change it, causing the drug to deteriorate or harm health.

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Shelf life

R-Cinex has a shelf life of 2 years. After this period, the drug should not be used for therapeutic or prophylactic purposes.

The expiration date of the drug must be taken into account without fail, because expired drugs lose their pharmacological properties and can harm the patient's health, especially if the storage conditions were violated. After the expiration date specified in the annotation to the drug, it must be immediately disposed of.

The shelf life of any medicine implies compliance with the rules of its storage. Only under such conditions will the medicine be beneficial and will not lose its important characteristics. Thus, in most cases, medicines, including R-Cinex, should be stored in a dry place, reliably protected from the sun. You should not buy several packages of the drug at once, it is better to do this as you use it. This way you can avoid the problem of the expiration of the medicine.

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