Cifran ST, pills 500mg+600mg, 10pcs

Composition

1 coated tablet contains:

active ingredients:

ciprofloxacin hydrochloride USP,

equivalent to ciprofloxacin 500 mg,

tinidazole BP 600 mg,

excipients:

microcrystalline cellulose,

colloidal anhydrous silicon,

magnesium stearate,

sodium starch glycolate,

sodium lauryl sulfate.

Ingredients of the outer layer of granules:

sodium starch glycolate,

purified talc,

sodium lauryl sulfate,

microcrystalline cellulose,

colloidal anhydrous silicon,

magnesium stearate.

Shell:

opadray yellow,

purified water.

Pharmacological action

Pharmacodynamics

Cifran ST is a combined drug intended for the treatment of mixed infections caused by anaerobic and aerobic microorganisms, as well as infections of the gastrointestinal tract, for example, diarrhea or dysentery, amoebic or mixed (amoebic and bacterial) nature. Tinidazole is effective against anaerobic microorganisms such as Clostridium difficile, Clostridium perfringens, Bacteroides fragilis, Peptococcus and Peptostreptococcus anaerobius. Anaerobic microorganisms cause mainly diseases of the abdominal, pelvic, lung or oral organs. In anaerobic infections, a mixture of anaerobic and aerobic bacteria is most often present. Therefore, in case of mixed anaerobic infection, an antibiotic active against aerobic bacteria is added to the therapy.

Ciprofloxacin is a broad-spectrum antibiotic, active against most aerobic gram-positive and gram-negative microorganisms, such as E. coli, Klebsiella spp., S. typhi and other Salmonella strains, P. mirabilis, P. vulgaris, Yersinia enterocoilitica, Ps. aeruginosa, Shigella flexneri, Shigella sonnei, H. ducreyi, H. influenzae, N. gonorrhoeae, M. catarrhalis, V. cholerae, B. fragilis, Staph. aureus (including methicillin-resistant strains), Staph. epidermidis, Strep. pyogenes, Strep. pneumoniae, chlamydia, Mycoplasma, Legionella and Mycobacterium tuberculosis.

Pharmacokinetics

Both ciprofloxacin and tinidazole are well absorbed in the gastrointestinal tract. Peak concentrations of each component are reached within 1-2 hours. The total bioavailability of tinidazole is 100%, and the binding to plasma proteins is 12%. The elimination half-life is about 12-14 hours. The drug quickly penetrates the body’s tissues, reaching high concentrations there. Tinidazole penetrates into the cerebrospinal fluid in a concentration equal to its concentration in plasma and undergoes reabsorption in the renal tubules. Tinidazole is excreted in the bile at concentrations slightly below 50% of its plasma concentration. About 25% of the dose taken is excreted unchanged in the urine.

Metabolites make up 12% of the administered dose and are also excreted in the urine. Along with this, there is a slight excretion of tinidazole in the faeces.

Ciprofloxacin is well absorbed after oral use. The bioavailability of ciprofloxacin is about 70%. When combined with food, the absorption of ciprofloxacin slows down. 20-40% of the drug binds to plasma proteins. Ciprofloxacin penetrates well into the body’s fluids and tissues: lungs, skin, fat, muscle and cartilage, as well as bone and urinary organs, including the prostate. The drug is found in high concentrations in saliva, mucus in the nasal cavity and bronchi, semen, lymph, peritoneal fluid, bile and prostate secretions. Ciprofloxacin is partially metabolized by the liver. About 50% of the dose taken is excreted unchanged in the urine, and 15% – in the form of active metabolites, such as oxocyprofloxacin. The remainder of the dose is excreted in the bile, partially reabsorbed. About 15-30% of ciprofloxacin is excreted in the faeces. The elimination half-life is about 3.5-4.5 hours. The elimination half-life may be prolonged in severe renal insufficiency and in elderly patients.

Indications

• Cifran ST is indicated for the treatment of the following infections:
• Treatment of 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, skin and soft tissue infections, ulcers on the “diabetic foot”, pressure sores, oral infections (including peridontitis and periostitis).
• Treatment of diarrhea or dysentery of amoebic or mixed (amoebic and bacterial)etiology.

Use during pregnancy and lactation

The use of Tsifran ST during pregnancy is not recommended. Tinidazole may have carcinogenic and mutagenic effects.

Ciprofloxacin penetrates the blood-placental barrier.

The use of Tsifran ST is contraindicated during breastfeeding. Tinidazole and Ciprofloxacin are excreted in breast milk.

Therefore, during lactation, if it is necessary to use Tsifran ST, you should stop breastfeeding.

Contraindications

• Cifran ST is contraindicated for use in patients with hypersensitivity (allergy) to any derivatives of fluoroquinolone or imidazole.
• Tsifran ST is also contraindicated in patients with a history of hematological diseases. With suppression of bone marrow hematopoiesis, acute porphyria.
• Tsifran ST is contraindicated in patients with organic neurological lesions.
• Tsifran ST is contraindicated in children under 18 years of age.

With caution, the drug should be used with caution in patients with severe atherosclerosis of the cerebral vessels, with impaired cerebral circulation, with mental illnesses, epilepsy, with epileptic syndrome, severe renal and /or hepatic insufficiency. When using the drug in the elderly, no significant problems were noted. However, elderly patients may have an age-dependent decrease in renal function, so caution should be exercised when using the drug in such patients.

Side effects

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 nervous system: headache, dizziness, increased fatigue, impaired coordination of movements (including locomotor ataxia), dysarthria, peripheral neuropathy, rarely convulsions, weakness, tremor, insomnia, increased sweating, increased intracranial pressure, confusion, depression, hallucinations, as well as other manifestations of psychotic reactions, migraines, fainting states, cerebral artery thrombosis.

Sensory disorders, taste and smell disorders, visual disturbances (diplopia, color perception changes), tinnitus, hearing loss.

From the cardiovascular system: tachycardia, cardiac arrhythmias, decreased blood pressure.

From the hematopoietic system: leukopenia, granulocytopenia, anemia, thrombocytopenia, leukocytosis, thrombocytosis, hemolytic anemia

From the laboratory parameters: hypoprothrombinemia, increased activity of “hepatic transminases” and alkaline phosphatase, hypercreatininemia, hyperbilirubinemia, hyperglycemia

From the urinary system: hematuria, crystalluria (alkaline urine and low diuresis), glomerulonephritis, dysuria, polyuria, urinary retention, decreased nitrogen-releasing function of the kidneys, interstitial nephritis.

Allergic reactions: pruritus, urticaria, blistering accompanied by bleeding and the appearance of small nodules forming scabs, drug fever, spot hemorrhages on the skin (petechiae), swelling of the face or larynx, shortness of breath, eosinophilia, increased photosensitivity, vasculitis, erythema nodosum, erythema multiforme exudative (including Stevens-Johnson syndrome), toxic epidermal Necrolysis (Lyell’s syndrome).

Others: arthralgia, arthritis, tendovaginitis, tendon tears, asthenia, myalgia, superinfections (candidiasis, pseudomembranous colitis), “hot flashes” of blood to the face.

Interaction

Tinidazole enhances 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).

It is compatible with sulfonamides and antibiotics (aminoglycazides, erythromycin, rifampicin, cephalosporins). It is not recommended to prescribe with ethionamide.

Phenobarbital accelerates your metabolism.

Ciprofloxacin, as a result of a decrease in the activity of microsomal oxidation processes in hepatocytes, increases the concentration and prolongs the half-life of theophylline (and other xanthines, such as caffeine), oral hypoglycemic drugs (drugs), indirect anticoagulants, and helps to reduce the prothrombin index.

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

Increases the nephrotoxic effect of cyclosprorin, there is an increase in serum creatinine, in such patients it is necessary to monitor this indicator 2 times a week

When taken simultaneously, it enhances the effect of indirect anticoagulants.

Oral use together with Fe-containing drugs, sucralfate and antacid drugs containing Mg2+, Ca%^%2+, and%^%13+ leads to a decrease in the absorption of ciprofloxacin, so it should be prescribed 1-2 hours before or 4 hours after taking the above drugs. Nonsteroidal anti-inflammatory drugs (excluding acetylsalicylic acid) increase the risk of seizures.Didanosine reduces the absorption of ciprofloxacin due to the formation of complexes with it, with Mg2+ and A13+contained in didanosine.

Metoclopramide accelerates absorption, which reduces the time to reach its maximum concentration. Co-use of uricosuric drugs leads to a slowdown in excretion(up to 50%) and an increase in the plasma concentration of ciprofloxacin.

How to take, course of use and dosage

Inside.

The drug should be taken after a meal, with a sufficient amount of water. Do not break, chew, or otherwise destroy the tablet.

Recommended dose for adults:Tsifran ST 500/600 mg – 1 tablet 2 times a day.

Overdose

There is no specific antidote, so treatment for overdose of Cifran ST should be symptomatic and include the following measures::

– Induce vomiting or perform gastric lavage. – Take measures for adequate hydration of the body (infusion therapy). – Maintenance therapy.

Special instructions

It is recommended to avoid excessive exposure to sunlight during the course of therapy with Cifran ST, since some patients treated with fluoroquinolones have experienced phototoxicity reactions. If phototoxicity reactions occur, the drug should be discontinued immediately.

When using tinidazole, it is possible (but rare) to develop generalized urticaria, swelling of the face and larynx, a decrease in blood pressure, bronchospasm and dyspnoea. If the patient is allergic to any imidazole derivative, then cross-sensitivity to tinidazole may develop; the development of a cross-allergic reaction to ciprofloxacin is also possible in patients with allergies to other derivatives of fluoroquinolones. Therefore, if the patient has experienced any allergic reactions to similar drugs, the possibility of cross-allergic reactions to Tsifran ST should be taken into account.

When tinidazole is co-administered with alcohol, painful abdominal cramps, nausea and vomiting may occur. Therefore, the combined use of Tsifran ST and alcohol is contraindicated.

To avoid the development of crystallurgy, it is unacceptable to exceed the recommended daily dose, as well as sufficient fluid intake and maintaining an acidic urine reaction. Causes dark staining of the urine.

During treatment, you should refrain from engaging in potentially dangerous activities that require increased attention and speed of mental and motor reactions.

Patients with epilepsy, seizures in the anamnesis, 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 “vital” indications.

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 appropriate treatment. If there is pain in the tendons or if the first signs of tendovaginitis appear, treatment should be discontinued.

During treatment, the picture of peripheral blood should be monitored. The safety and efficacy of its use for the treatment and prevention of anaerobic infections in children under 12 years of age has not been established.

Form of production

Film-coated tablets

Storage conditions

In a dry place, at a temperature not exceeding 25 °C

Shelf life

2 years

Active ingredient

Tinidazole, Ciprofloxacin

Conditions of release from pharmacies

By prescription

Dosage form

Tablets

Purpose

For adults as directed by your doctor

Indications

Bedsores, Osteomyelitis, Inflammation of the female genital organs, Skin Infections, Periodontitis, Urinary Tract Infections, Sinusitis, Intestinal infections