Cifran ST tablets 500 + 600mg, No. 10

Mixed infections caused by sensitive anaerobic and aerobic microorganisms:

• chronic sinusitis;

• lung abscess;

• empyema;

• intra-abdominal infections;

• inflammatory gynecological diseases;

• postoperative infections with the possible presence of aerobic and anaerobic bacteria;

• chronic osteomyelitis;

• infections of the skin and soft tissues;

• skin ulcers with diabetic foot;

• bedsores;

• oral infections (including periodontitis and periostitis).
  
  Diarrhea or dysentery of amoebic or mixed (amoebic and bacterial) etiology.

Inside, after meals, drinking plenty of water. Do not crush, chew, or break the tablet.

Recommended dose: tablets with a ratio of ciprofloxacin / tinidazole 250/300 mg - 2 tab. 2 times / day, 500/600 mg - 1 tab. 2 times / day

ciprofloxacin (in the form of monohydrate hydrochloride) 500 mg

tinidazole 600 mg

• hypersensitivity (including to fluoroquinolone or imidazole derivatives);

• blood diseases (history);

• oppression of bone marrow hematopoiesis;

• acute porphyria;

• organic diseases of the central nervous system;

• age under 18;

• pregnancy;

• lactation period.

With care : severe atherosclerosis of the cerebral vessels, cerebrovascular accident, mental illness, epilepsy, a history of seizures, severe renal and / or hepatic failure, old age.

pharmachologic effect

Combined drug. Tinidazole is an antiprotozoal and antimicrobial agent, an imidazole derivative, effective against anaerobic microorganisms such as Clostridium difficile, Clostridium perfringens, Bacteroides fragilis, Peptococcus and Peptostreptococcus anaerobius.

Ciprofloxacin is a broad-spectrum antibiotic, active against most aerobic gram-positive and gram-negative microorganisms, such as Escherichia coli, Klebsiella spp., Salmonella typhi and other strains of Salmonella, Proteus mirabilis, Proteus vulgaris, Yersinia flexinia enterocoilitica, Pseudomonella sonigella aerigella , Haemophilus ducreyi, Haemophilus influenzae, Neisseria gonorrhoeae, Moraxella catarrhalis, Vibrio cholerae, Bacteroides fragilis, Staphylococcus aureus (including methicillin-resistant strains), Staphylococcus epidermidium.

Pharmacokinetics

Both ciprofloxacin and tinidazole are well absorbed in the gastrointestinal tract after oral administration. The time to reach the Cmax of each component is 1-2 hours. The drug quickly penetrates into the tissues of the body, reaching high concentrations there. It is found in high concentrations in saliva, nasal and bronchial secretions, semen, lymph, peritoneal fluid, bile and prostate secretions.

Bioavailability of tinidazole is 100%, protein binding is 12%. T1 / 2 - 12-14 hours. Tinidazole enters the cerebrospinal fluid at a concentration equal to that in plasma, and undergoes reabsorption in the renal tubules. Tinidazole is excreted in bile at concentrations slightly below 50% of its plasma concentration. About 25% is excreted unchanged in the urine, 12% - in the form of metabolites. Insignificant amounts are excreted in the feces.

The bioavailability of ciprofloxacin is about 70%. Simultaneous food intake slows down absorption. The connection with proteins is 20-40%. Ciprofloxacin penetrates well into fluids and body tissues: lungs, skin, adipose, muscle and cartilage tissues, as well as bone tissue and organs of the urinary system, including the prostate gland. Ciprofloxacin is partially metabolized in the liver. T1 / 2 - about 3.5-4.5 hours, can be lengthened with severe renal failure and in elderly patients. About 50% is excreted unchanged in the urine, 15% - in the form of active metabolites (including oxocyprofloxacin). The rest is excreted in the bile, partially being reabsorbed. About 15-30% of ciprofloxacin is excreted in the feces.

Side effect

From the digestive system: decreased appetite, dryness of the oral mucosa, 'metallic' taste in the mouth, nausea, vomiting, diarrhea, abdominal pain, flatulence, cholestatic jaundice (especially in patients with previous liver diseases), hepatitis, hepatonecrosis.

From the side of the central nervous system and peripheral nervous system : headache, dizziness, increased fatigue, impaired coordination of movements (including locomotor ataxia), dysarthria, peripheral neuropathy, rarely - convulsions, weakness, tremor, insomnia, increased intracranial pressure, confusion , depression, hallucinations, as well as other manifestations of psychotic reactions, migraine, cerebral artery thrombosis.

From the senses:disorders of taste and smell, visual impairment (diplopia, change in color perception), tinnitus, hearing loss.

From the side of the cardiovascular system: tachycardia, arrhythmia, decreased blood pressure, fainting.

From the side of hematopoiesis: leukopenia, granulocytopenia, anemia (including hemolytic), thrombocytopenia, leukocytosis, thrombocytosis.

From the urinary system: hematuria, crystalluria (with an alkaline reaction of urine and a decrease in urine output), glomerulonephritis, dysuria, polyuria, urinary retention, decreased nitrogen excretion function of the kidneys, interstitial nephritis.

Allergic reactions:pruritus, urticaria, skin rash, drug fever, petechiae, edema of the face or larynx, dyspnea, eosinophilia, photosensitivity, vasculitis, erythema nodosum, exudative erythema multiforme (including Stevens-Johnson syndrome), toxic epidermal necrolysis (toxic epidermal necrolysis) ).

On the part of laboratory parameters: hypoprothrombinemia, increased activity of hepatic transaminases and alkaline phosphatase, hypercreatininemia, hyperbilirubinemia, hyperglycemia.

Others: arthralgia, arthritis, tendovaginitis, tendon ruptures, asthenia, myalgia, superinfections (candidiasis, pseudomembranous colitis), flushing of the face, increased sweating.

Contraindications for use

• hypersensitivity (including to fluoroquinolone or imidazole derivatives);

• blood diseases (history);

• oppression of bone marrow hematopoiesis;

• acute porphyria;

• organic diseases of the central nervous system;

• age under 18;

• pregnancy;

• lactation period.

With care : severe atherosclerosis of the cerebral vessels, cerebrovascular accident, mental illness, epilepsy, a history of seizures, severe renal and / or hepatic failure, old age.

Application during pregnancy and lactation

The use of the drug during pregnancy is not recommended. Tinidazole may be carcinogenic and mutagenic. Ciprofloxacin crosses the placental barrier.

Tinidazole and ciprofloxacin are excreted in breast milk. Therefore, if it is necessary to use the drug during lactation, breastfeeding should be discontinued.

Application for violations of liver function

With care : severe hepatic impairment.

Application for impaired renal function

With care : severe renal failure.

Application in children

Contraindicated in children and adolescents under 18 years of age.

Use in elderly patients

With care : old age.

special instructions

It is recommended to avoid excessive exposure to sunlight during treatment. If photosensitization reactions occur, the drug should be discontinued immediately.

When using tinidazole (an imidazole derivative), it is possible (rarely) to develop generalized urticaria, edema of the face and larynx, lowering blood pressure, bronchospasm and dyspnea. Therefore, patients with hypersensitivity to other imidazole derivatives may develop cross-sensitivity to tinidazole; the development of a cross-allergic reaction to ciprofloxacin is also possible in patients with hypersensitivity to other fluoroquinolone derivatives. Consideration should be given to the possibility of cross-allergic reactions.

During the period of treatment, it is not recommended to take ethanol (the risk of developing disulfiram-like reactions against the background of tinidazole, which is part of the drug).

In order to avoid the development of crystalluria, the recommended daily dose must not be exceeded; sufficient fluid intake and maintenance of an acidic urine reaction are also necessary. Causes a dark coloration of urine, which has no clinical significance.

Patients with epilepsy, a history of seizures, vascular diseases and organic brain lesions, due to the threat of adverse reactions from the central nervous system, the drug should be prescribed only for health reasons.

If severe and prolonged diarrhea occurs during or after treatment, the diagnosis of pseudomembranous colitis should be excluded, which requires immediate discontinuation of the drug and the appointment of appropriate treatment.

If pain in the tendons appears or when the first signs of tendovaginitis appear, treatment should be discontinued.

During treatment, the picture of peripheral blood should be monitored.

During treatment, one should refrain from engaging in potentially hazardous activities that require increased concentration of attention and speed of psychomotor reactions.

Drug interactions

Tinidazole .

Strengthens the effect of indirect anticoagulants (to reduce the risk of bleeding, the dose is reduced by 50%) and the effect of ethanol (disulfiram-like reactions).

Compatible with sulfonamides and antibiotics (aminoglycosides, erythromycin, rifampicin, cephalosporins).

It is not recommended to prescribe with ethionamide.

Phenobarbital speeds up metabolism.

Ciprofloxacin .

Due to a decrease in the activity of microsomal oxidation processes in hepatocytes, it increases the concentration and lengthens T1 / 2 of theophylline (and other xanthines, including caffeine), oral hypoglycemic drugs, indirect anticoagulants, helps to reduce the prothrombin index.

When combined with other antimicrobial drugs (beta-lactam antibiotics, aminoglycosides, clindamycin, metronidazole), synergism is usually observed.

Enhances the nephrotoxic effect of cyclosporin, there is an increase in serum creatinine, in such patients it is necessary to control this indicator 2 times a week.

Oral administration together with iron-containing drugs, sucralfate and antacid drugs containing magnesium, calcium, aluminum salts leads to a decrease in the absorption of ciprofloxacin, therefore it should be prescribed 1-2 hours before or 4 hours after taking the above drugs.

NSAIDs (excluding acetylsalicylic acid) increase the risk of seizures.

Didanosine reduces the absorption of ciprofloxacin due to the formation of complexes with magnesium and aluminum ions contained in didanosine.

Metoclopramide accelerates absorption, which leads to a decrease in the time to reach Cmax.

Joint administration with uricosuric drugs leads to a slowdown in excretion (up to 50%) and an increase in the plasma concentration of ciprofloxacin.