Ciprolet a pill №10

Dosage form

Pills

Composition

1 coated pill contains: Ciprofloxacin hydrochloride monohydrate 582.285 mg, which corresponds to the content of ciprofloxacin 500 mg, Tinidazole 600 mg.
Excipients: corn starch, croscarmellose sodium, microcrystalline cellulose, sodium carboxymethyl starch (type A), colloidal silicon dioxide, talc, Magnesium stearate.
The composition of the film shell: hypromellose (6 cps), sorbic acid, titanium dioxide, talc, macrogol 6000, polysorbate 80, dimethicone, dye sunsets yellow (E110).

Packing

In the blister of 10 tablets. In a carton one blister.

Mechanism of action

Ciprolet A is a combined preparation, the action of which is caused by the components that make up its composition.
Tinidazole is an antiprotozoal and antimicrobial agent, an imidazole derivative.
Active against: Trichomonas vaginalis, Entamoeba histolitica, Lamblia, causative agents of anaerobic infections: Clostridium spp, Bacteroides fragilis, Bacteroides melaninogenicus, Eubacter spp, Fusobacterium spp, Peptococcus spp, Pesttope spp, Fusobacterium spp.
Being a highly lipophilic compound, tinidazole penetrates into Trichomonas and anaerobic microorganisms, where it is restored by nitroreductase, inhibits synthesis and damages the structure of DNA.
Ciprofloxacin - a broad-spectrum antimicrobial agent, a fluoroquinolone derivative, inhibits bacterial DNA gyrase (topoisomerases II and IV, which are responsible for the supercoiling of chromosomal DNA around nuclear RNA, which is necessary for reading genetic information), violates the synthesis of DNA, growth and division of bacteria; causes pronounced morphological changes (including cell walls and membranes) and the rapid death of the bacterial cell.
It acts bactericidal on Gram-negative organisms in the period of rest and division (since it affects not only the DNA gyrase, but also causes lysis of the cell wall), on gram-positive microorganisms - only in the period of division. Low toxicity to the cells of the microorganism is explained by the absence of DNA gyrase in them. While taking ciprofloxacin, parallel development of resistance to other antibiotics not belonging to the group of gyrase inhibitors does not occur, which makes it highly effective against bacteria resistant to aminoglycosides, penicillins, cephalosporins, tetracyclines and many other antibiotics.
Ciprofloxacin is active against:
Gram-negative aerobic bacteria: Escherichia coli, Salmonella spp., Shigella spp., Citrobacter spp., Klebsiella spp., Enterobacter spp., Proteus mirabilis, Proteus vulgaris, Serratia marcescens, Hafnia alvei, Edwardsiel tarda, Prov.
Other gram-negative bacteria: Haemophilus spp, Pseudomonas aeruginosa, Moraxella catarrhalis, Aeromonas spp, Pasteurella multocida, Plesiomonas shigelloides, Campylobacter jejuni, Neisseria spp.
Some intracellular pathogens: Legionella pneumophila, Brucella spp, Listeria monocytogenes, Mycobacterium tuberculosis, Mycobacterium kansasii.
Gram-positive aerobic bacteria: Staphylococcus aureus, Staphylococcus haemolyticus, Staphylococcus hominis, Staphylococcus saprophyticus, Streptococcus pyogenes, Streptococcus agalactiae.
Most methicillin-resistant staphylococci are resistant to ciprofloxacin. Resistance develops extremely slowly, since, on the one hand, after the action of ciprofloxacin, there are practically no persistent microorganisms left, and on the other, bacterial cells do not have its inactivating enzymes.
Resistant to the drug: Bacteroides fragilis, Pseudomonas cepacia, Pseudomonas maltophilia. Ureaplasma urealyticum, Clostridium difficile, Nocardia asteroides.
He is effective against Treponema pallidum.

Mixed bacterial infections caused by sensitive gram-positive and gram-negative microorganisms, in association with anaerobic microorganisms and / or protozoa:
- Respiratory tract infections: acute bronchitis, chronic bronchitis in the acute stage, pneumonia, bronchiectasis.
- Infections of ENT organs: otitis media, antritis, sinusitis, sinusitis, mastoiditis, tonsillitis, pharyngitis.
- Infections of the oral cavity: acute ulcerative gingivitis, periodontitis, periostitis.
- Infections of the kidneys and urinary tract: cystitis, pyelonephritis.
- Infections of the pelvic organs and genital organs: prostatitis, adnexitis, salpingitis, oophoritis, endometritis, tubular abscess, pelvioperitonitis.
- Intraabdominal infections: gastrointestinal infections, infections of the biliary tract, intraperitoneal abscesses.
- Infections of the skin and soft tissues: infected ulcers, wounds, burns, abscesses, phlegmon, ulcers of the skin in diabetic foot syndrome, pressure sores.
- Infections of bones and joints: osteomyelitis, septic arthritis, postoperative infections.

Contraindications

- Blood diseases (in history).
- Inhibition of bone marrow hematopoiesis.
- Organic diseases of the central nervous system.
- Pregnancy.
- Lactation period (breastfeeding).
- Simultaneous intake with tizanidine (risk of marked reduction in blood pressure, drowsiness).
- Acute porphyria.
- Children's and teenage age up to 18 years.
- Hypersensitivity to the drug.
- Hypersensitivity to fluoroquinolone or imidazole derivatives.
With care when:
- Severe atherosclerosis of the cerebral vessels.
- Violation of cerebral circulation.
- Mental diseases.
- Epilepsy.
- Indications of convulsions in history.
- Severe renal and / or liver failure.
- In elderly patients.

Pregnancy and Breastfeeding

The drug is contraindicated in pregnancy and lactation (breastfeeding). Tinidazole and ciprofloxacin are excreted in breast milk, so for the period of drug treatment it is necessary to stop breastfeeding.

Dosage and administration

The drug is prescribed by mouth, 1 hour before meals or 2 hours after meals. The recommended dose is 1 pill 2 for 5-10 days. pills should be taken with a large amount of water. Do not crush, chew or destroy the tablet.

Should consider the possibility of cross-allergic reactions. Patients with hypersensitivity to otherimidazole 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. During treatment it is recommended to avoid contact with direct sunlight. In the event of photosensitivity reactions should immediately discontinue use of the drug.
During treatment, it is not recommended to take ethanol (the risk of 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 should not be exceeded, sufficient fluid intake and maintenance of acidic urine is also necessary. The drug causes dark staining of urine, which has no clinical significance.
Patients with epilepsy, convulsions in history, vascular diseases and organic brain damage, due to the threat of adverse reactions from the central nervous system, the drug should be prescribed only for health reasons.
If severe or prolonged diarrhea occurs during or after treatment, diagnosis of pseudomembranous colitis should be excluded, which requires immediate discontinuation of the drug and appropriate treatment. If there is pain in the tendons or when the first signs of tendovaginitis appear, treatment should be stopped. With treatment for more than 6 days, a picture of peripheral blood should be monitored.Tinidazole has been shown to have a mutagenic and carcinogenic effect.
Influence on ability to drive motor transport and control mechanisms: During treatment, the patient should refrain from practicing potentially hazardous activities that require increased concentration and psychomotor speed.

Drug interactions

Effects of tinidazole
Ciprolet A enhances the effect of indirect anticoagulants. To reduce the risk of bleeding, the dose of Ciprolet®A is reduced by 50%. Enhances the action of ethanol (disulfiram-like reactions). Phenobarbital accelerates the metabolism of tinidazole. Ciprolet A is not recommended to be administered simultaneously with ethionamide.
Effects due to ciprofloxacin
Due to a decrease in the activity of microsomal oxidation processes in hepatocytes, it increases the concentration and lengthens the T1 / 2 of theophylline and other xanthines, including caffeine, oral hypoglycemic drugs, indirect anticoagulants, helps to reduce the prothrombin index. Enhances the nephrotoxic effect of cyclosporine, an increase in serum creatinine, there is a need in these patients to control this indicator 2 times a week. Oral administration in conjunction with iron-containing drugs, sucralfate and antacid drugs containing Mg2 +, Ca2 +, Al3 +, with didanosine reduces the absorption of ciprofloxacin.Therefore, Ciprolet A should be prescribed 1-2 hours before or 4 hours after taking these medicines. With simultaneous use with NSAIDs (excluding acetylsalicylic acid) increases the risk of seizures. Metoclopramide accelerates the absorption of ciprofloxacin, which leads to a decrease in Tmax. Co-administration of uricosuric drugs leads to a slowdown of excretion (up to 50%) and an increase in the plasma concentration of ciprofloxacin. Ciprofloxacin increases Cmax by 7 times (from 4 to 21 times) and AUC of tizanidine, which increases the risk of a pronounced decrease in blood pressure and drowsiness.
Ciprolet A is compatible with sulfonamides and antibiotics (beta-lactam antibiotics, aminoglycosides, Erythromycin , rifampicin, cephalosporins), when combined with which synergism is usually observed.

Symptoms: in cases of acute overdose, symptoms of reversible damage to the urinary system will prevail, seizures may occur.
Treatment: induction of vomiting, gastric lavage. Symptomatic, supportive therapy (including adequate hydration of the body). There is no specific antidote. Using hemo- or peritoneal dialysis, tinidazole can be completely eliminated from the body, and ciprofloxacin - only slightly (less than 10%).

Store at a temperature not higher than 25 ° С.