R-Cinex

R-Cinex (R-CINEX) is a combination drug, which includes components that have an active antituberculous effect:

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

[1], [2], [3]

Indications R-Cinex

Indications for use P-Cynex - all forms of tuberculosis (pulmonary and extrapulmonary), as well as infectious diseases of a non-specific nature that are caused by sensitive microorganisms ( pyelonephritis, pneumonia, osteomyelitis ); presence of meningococci in the nasopharyngeal carriers.

Antituberculosis drugs include medicines intended for the prevention and effective treatment of tuberculosis. Their therapeutic effect, first of all, is related to bacteriostatic action. R-Cynex should be combined with some other anti-tuberculosis drug due to the possibility of resistance of the causative agents of tuberculosis to rifampicin.

[4]

Release form

P-Cynex is available as a suspension for oral administration, capsules that contain rifampicin (0.45 g) and isoniazid (0.3 g), as well as coated tablets (P-CINEX Z): Rifampicin + Isoniazid + Pyrazinamide).

The form of release of the drug in different versions makes it possible to choose the optimal one, depending on the patient's condition and the features of the course of the disease.

Capsules of R-Cynex are available in 80 pieces in 1 package: 450 mg of rifampicin +300 mg of isoniazid. Suspension - 100 ml of the drug in vials.

Tablets P-Cynex Z (R-CINEX Z) contain 0.225 g of rifampicin, 0.15 g of isoniazid and 0.75 g of pyrazinamide.

When taking P-Cynex in any form, one should take into account the fact that rifampicin is peculiar to stain body fluids (urine, sweat, tears), as well as contact lenses, feces and skin in an orange-red hue. Prolonged use of the drug requires systematic monitoring of liver function (at least 1 time per month), ophthalmologist observations and control of peripheral blood picture.

When observing the development of persistent abnormalities in treatment, treatment with P-Cinex should be interrupted and resumed only after a clear normalization of laboratory as well as clinical indicators.

[5]

Pharmacodynamics

R-Cynex is a combined drug whose main active ingredient is rifampicin (a rifamycin derivative), a semi-synthetic antibiotic with a pronounced bactericidal effect.

Pharmacodynamics R-Cynex is a combination of the medicinal substances that make up the drug and the mechanisms of their action. The main effect is the suppressive effect of rifampicin on the synthesis of RNA bacteria, as well as Gram-negative and Gram-positive microorganisms: Mycobacterium tuberculosis, N. Meningitides, Mycobacterium leprae, Streptococcus spp., Staphylococcus spp., Bacillus anthracis, Pseudomonas, E. Coli, Proteus and Klebsiella, Brucella spp., Salmonella typhi, Legionella pneumophila, and others.

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

[6], [7]

Pharmacokinetics

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

Pharmacokinetics of P-Cynex: the main active ingredient, rifampicin, is readily absorbed from the gastrointestinal tract and spreads rapidly over all the fluids, tissues and bones of the human body. The only thing - you need to consider that its absorption is somewhat reduced with simultaneous intake of food. In plasma, the maximum concentration of the substance is achieved in 2-3 hours.

More rifampicin (60-80%) is metabolized in the liver, the rest in the intestinal wall (30-45%), where the active metabolites formylfampamp and deacetyltriphampin, which retain their anti-tuberculosis activity. The time exponent of the half-life of P-Cinex is 1.5-5 hours. The drug is excreted by the liver (up to 60%) and urine (up to 30%).

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

[8], [9], [10]

Dosing and administration

R-Cynex should be taken strictly according to the scheme indicated by the attending physician, based on laboratory blood tests, the presence of chronic diseases in the patient and other factors that may cause side effects of the drug, or prohibit its reception.

Dosing and Administration: Usually the drug is administered orally on 1 tablet (capsule) per day during the entire therapeutic course. Adults need to take P-Cynex taking into account the body weight: if it is less than 50 kg, - 450 mg, if more than 50 kg, - up to 600 mg (this is the maximum figure). Children the drug is prescribed in a dosage of 10 to 15 mg per day. In chronic renal failure, the figure is 8 mg / kg.

It should be remembered the need for systematic monitoring of liver function with prolonged use of R-Cynex, as well as observation of the picture of peripheral blood and ophthalmic control. It is not recommended to perform microbiological tests to determine the concentration in the blood serum of vitamin B12, as well as folic acid. Taking R-Cinex requires the patient to refrain from taking ethanol.

The development of persistent abnormalities in the liver requires immediate interruption of R-Cinex treatment. The resumption of therapy is possible only after the normalization of indicators - both clinical and laboratory.

[16], [17]

Use R-Cinex during pregnancy

R-Cynex can be used in the treatment of tuberculosis in pregnant women, but following the instructions, before starting treatment, one should weigh the pros and cons of such therapy, assessing its intended use for the mother and all possible risks for the baby. Only with this condition should be allowed to take the drug.

Use of P-Cynex 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 antituberculous 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-Zinex as a therapeutic drug.

Given the penetration of rifampicin into various fluids and tissues of the human body, it is not difficult to assume that it is excreted together with breast milk. Therefore, using this medication during lactation, the mother will need to give up breastfeeding the newborn.

Contraindications

R-Cynex, like any other drugs with bactericidal action, has a number of contraindications, which must be taken into account before starting treatment.

Contraindications for P-Cynex, as well as the conditions under which it should be used with caution:

• hypersensitivity to components present in the composition of the drug;
• pregnancy (first trimester);
• pregnancy (second and third trimesters);
• the period of breastfeeding;
• liver failure;
• various liver diseases (including anamnesis);
• children's age up to 12 years;
• elderly age;
• chronic renal failure;
• chronic alcoholism;
• general weakness of the body.

In addition to the above conditions, in which the reception of P-Cynex is undesirable, it is necessary to take into account the presence in the patient of such diseases as hyperuricemia (increased uric acid level in the blood), purpura (a disease whose main feature is the tendency to bleeding), gout (joint disease, conditioned deposition of uric acid in them). The administration of P-Cynex is also not recommended for pulmonary-cardiac insufficiency of II-III degree, as well as for acute liver diseases, including jaundice.

[11], [12], [13]

Side effects R-Cinex

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

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

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

In addition to the above side effects of R-Cynex, there are other: hepatitis, nephronecrosis, disorientation, leukopenia, hyperuricemia, myasthenia gravis, etc. Irregular reception or resumption of treatment with R-Cynex can trigger an influenza-like syndrome, the symptoms of which are chills, headache and dizziness, weakness , fever, myalgia. Possible complications in the form of skin reactions, the emergence of acute renal failure, as well as hemolytic anemia.

Isoniazid, which is part of the preparation of P-Cynex, can cause excessive fatigue and weakness, or euphoria, irritability, insomnia, as well as paresthesia, psychosis, polyneuritis, peripheral neuropathy, depression. On the part of the cardiovascular system, malfunctions can occur in the form of angina, rapid heart rate, increased blood pressure. Among the rare side symptoms are gynecomastia, menorrhagia, and the body's tendency to bleed and bleed.

For more details on all types of adverse symptoms of P-Cynex, see the instructions for this medication.

[14], [15]

Overdose

R-Cynex should be taken without exceeding the dosages indicated in the instructions or the medical regimen. This is a very important condition, because due to an overdose of the drug, serious and even life-threatening complications may occur in the patient.

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

So, an overdose of rifampicin can lead to:

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

When observing such symptoms of overdose, it is necessary to carry out symptomatic treatment: appoint the patient gastric lavage, take sorbents, conduct forced diuresis (method of detoxification with emergency therapy).

With an overdose of isoniazid, the following symptoms can occur:

• lethargy and dizziness,
• disorientation (violation of orientation) and confusion,
• hyperreflexia (amplification of reflexes),
• dysarthria (speech disturbance),
• metabolic acidosis (a violation in the body of acid-base balance),
• peripheral polyneuropathy (peripheral nerve disease),
• failures in the liver,
• Hyperglycemia (increased blood sugar),
• convulsions (usually occur a couple of hours after taking P-Cynex),
• coma.

When the patient develops peripheral polyneuropathy, B vitamins (B12, B6, B1), as well as glutamic acid, nicotinamide, ATP, various physiotherapeutic procedures and massage are prescribed. If the patient has seizures, a complex treatment should be used: vitamin B6 (in / m 200-250 mg), 25% solution of magnesium sulfate (IM per 10 ml), as well as 40% dextrose solution (iv 20 ml ) and diazepam. In case of liver failure, such drugs as vitamin B12, ATP, methionine and lipid are usually prescribed.

[18]

Interactions with other drugs

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

Interactions of P-Cynex with other drugs:

• R-Cynex is able to reduce the effect of hormonal contraceptives, oral anticoagulants, quinidine, ketoconazole, digitalis preparations, hypoglycemic and antiarrhythmic drugs, as well as other drugs (see details in the instructions for R-Cinex);
• by means of rifampicin, the parameters of bromosulfalein withdrawal (the process speed is increased);
• the lower bioavailability of rifampicin is promoted by anticholinergic drugs, opiates and antacids, ketoconazole;
• the combination of rifampicin with isoniazid and / or pyrazinamide exacerbates abnormalities in liver function in patients with a history of this disease;
• preparations PASK (paraaminosalicylic acid), which contain bentonite, are prescribed 4 hours after the use of R-Cynex;
• isoniazid can increase the concentration of phenytoin (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.

[19], [20], [21], [22]

Storage conditions

R-Cinex must be stored in a dark place, protected from direct sunlight. The temperature regime in this case should not be more than 25 ° C (this information is indicated in the instructions for the preparation).

The storage conditions of P-Cynex are almost the same as those of other medicines: inaccessibility to children, maintaining optimal temperature balance and dryness. It should be remembered that the expired medicine must be thrown away, even if it has not been expended to the end.

Tablets and capsules are "afraid" of moisture, so it is strictly not recommended to store them in the bathroom, in the kitchen, in the balcony or in another moist environment. The best option is a bedroom and any other room, which has a locker or chest. Keep medicines better in a box with a tight lid, on the upper shelves of the closet, where they are not enough for children. All bottles and blisters must be kept closed, in their original packaging.

Tablets and capsules of R-Cynex should be removed from the blisters immediately before use. This is due to the hygroscopicity of solid dosage forms. To protect any medicine from the sun means to protect it from heating, which, in turn, can affect the composition of the drug and even change it, because of what the medicine will deteriorate or harm your health.

[23], [24]

Shelf life

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

Shelf life of the drug must be taken into account without fail, because overdue drugs lose their pharmacological properties and can harm the patient's health, especially if the storage conditions were violated. After the expiry date indicated in the annotation to the medicinal product, it must be disposed of immediately.

The validity period of any medicinal product implies the fulfillment of the rules for its storage. Only under such conditions, the medicine will bring benefits and will not lose its important characteristics. So, in most cases, medications, including R-Cynex, should be stored in a dry, secure place protected from the sun. Do not buy a few packs of the drug at once, it is better to do it as you use. So you can avoid problems with the expiration of the expiration date of the drug.

[25], [26], [27]