Cyfran® ST (Cifran® CT)

Composition Pharmacodynamics Indications Carefully Contraindications Dosing and Administration Side effects Form release / dosage
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Active substanceTinidazole + CiprofloxacinTinidazole + Ciprofloxacin
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  • Ciprolet® A
    pills inwards 
    Dr. Reddy's Laboratories Ltd.     India
  • Cyfran® ST
    pills inwards 
    Ranbaxy Laboratories Limited     India
    • Dosage form: & nbspfilm coated tablets
    Composition:
    Each tablet contains:
    Active substances:
    tinidazole 600 mg
    ciprofloxacin hydrochloride 610.66 mg,
    Ciprofloxacin equivalent 500 mg.
    Excipients: microcrystalline cellulose * - 83.68 mg, colloidal silicon dioxide 28.00 mg, magnesium stearate 9.334 mg, sodium carboxymethyl starch 56.00 mg, sodium lauryl sulfate 10.00 mg, talc purified 2.334 mg.
    Sheath of tablet: opadraj yellow 31F52949 - 38,50 mg, purified water ** - q.s. Fill yellow 31F52949: HPMC 2910 / Hypromellose 15 cc - 36.00% w / w, lactose monohydrate 28.00% w / w, titanium dioxide 20.962% w / w, macrogol 4000-10.00% w / w, dye iron oxide yellow - 5,038% mass / mass.
    * The amount is adjusted based on the actual amount of ciprofloxacin hydrochloride and tinidazole, to maintain a constant tablet weight.
    ** evaporates in the production process.

    Description:biconvex tablets of oval form, yellow, with a risk on one side, covered with a film membrane. Type of tablets at break: homogeneous pressed mass from white to almost white
    Pharmacotherapeutic group:antimicrobial agent combined.
    ATX: & nbsp

    J.01.R.A   Combinations of antibacterial drugs

    J.01.R.A.11   Ciprofloxacin and Tinidazole

    Pharmacodynamics:
    Pharmacodynamics
    Tsifran® ST is a combined preparation, the active substances of which are tinidazole and ciprofloxacin, intended for the treatment of infections caused by anaerobic and aerobic microorganisms.
    Tinidazole has antiprotozoal and antimicrobial action. The mechanism of action is associated with the inhibition of synthesis and the violation of the structure of DNA-sensitive microorganisms. Tinidazole is effective against protozoa (Trichomonas vaginalis, Entamoeba histolytica, Lamblia spp.) and anaerobic microorganisms (Clostridium difficile, Clostridium perfringens, Bacteroides fragilis, Peptococcus, Fusobacterium spp., Gardnerella vaginalis, Bacteroides melaninogenicus, Eubacterium spp., and Peptostreptococcus anaerobius).
    Ciprofloxacin is a broad-spectrum antibiotic from the group of fluoroquinolones. Inhibits the DNA enzyme of the bacterial DNA, as a result of which DNA replication and the synthesis of bacterial cell proteins are disturbed. It is active against most aerobic Gram-positive and Gram-negative microorganisms, such as E. coli, Klebsiella spp., S. typhi and other strains of Salmonella, Proteus mirabilis, Proteus vulgaris, Yersinia enterocolitica, Pseudomonas aeruginosa, Shigella flexneri, Shigella sonnei, Haemophilus ducreyi, Haemophilus influenzae, Neisseria gonorrhoeae, Moraxella catarrhalis, Vibrio cholerae, Staphylococcus aureus (including methicillin resistant strains), Staphylococcus epidermidis, Streptococcus pyogenes, Streptococcus pneumoniae, Chlamydia trachomatis, Chlamydia pneumonia, Mycoplasma pneumonia, Mycoplasma hominis, Legionella pneumophila and Mycobacterium tuberculosis.

    Pharmacokinetics:
    how ciprofloxacin, and tinidazole well absorbed in the gastrointestinal tract. Peak concentrations of each component are achieved within 1 to 2 hours. Bioavailability of tinidazole is 100%, and binding to plasma proteins is 12%. Half-life is about 12-14 hours. Tinidazole quickly penetrates into the tissues of the body, reaching there high concentrations, penetrates the cerebrospinal fluid at a concentration equal to its concentration in the plasma and is reabsorbed in the renal tubules. Tinidazole excreted in bile in concentrations slightly below 50% of its serum concentration. About 25% of the accepted dose is excreted unchanged by the kidneys. Metabolites account for 12% of the administered dose and are also excreted by the kidneys. Along with this, there is an insignificant elimination of tinidazole through the gastrointestinal tract.
    Ciprofloxacin is well absorbed after oral administration. Bioavailability of ciprofloxacin is about 70%. When combined with food, the absorption of ciprofloxacin slows down. 20-40% of ciprofloxacin binds to plasma proteins. Ciprofloxacin well penetrates into fluid media and body tissues: lungs,
    skin, fatty, muscular and cartilaginous tissues, as well as in bone tissue and organs of the genitourinary system, including prostate gland. Ciprofloxacin is found in high concentrations in saliva, mucus of the nasal cavity and bronchi, lymph, peritoneal fluid, bile and semen. Partially ciprofloxacin is metabolized by the liver. About 50% of the accepted dose is excreted unchanged by the kidneys. 15% of the accepted dose is excreted by the kidneys in the form of active metabolites, such as oxocyclophloxacin. The rest of the dose is excreted with bile, partially reabsorbed. About 15 - 30% of ciprofloxacin is excreted through the gastrointestinal tract. Half-life is about 3.5 - 4.5 hours. The half-life can be prolonged with severe renal failure and in elderly patients.

    Indications:
    Mixed bacterial infections caused by sensitive Gram-positive and Gram-negative microorganisms, in association with aerobic and anaerobic microorganisms and / or protozoa:
    • diseases of the lower respiratory tract (acute and chronic (at the stage of exacerbation) bronchitis, pneumonia, bronchiectatic disease);
    • infection of ENT organs (pharyngitis, tonsillitis, mastoiditis, sinusitis, frontal sinus, maxillary sinusitis, otitis media);
    • oral cavity infections (periodontitis, periostitis, acute ulcerative gingivitis);
    • infections of the skin and soft tissues (infected ulcers, ulcerative skin lesions with "diabetic foot syndrome," pressure ulcers, wounds, burns, abscesses, phlegmon);
    • infection of bones and joints (septic arthritis, osteomyelitis);
    • infections of the pelvic organs and genital organs (pelvic peritonitis, tubular abscess, endometritis, oophoritis, salpingitis, prostatitis), including in combination with trichomoniasis;
    • infection of the kidneys and urinary tract (pyelonephritis, cystitis);
    • infections of the gastrointestinal tract (typhoid fever, shigellosis, amoebiasis);
    • complicated intra-abdominal infections;
    • prevention of infections after surgery.

    Contraindications:
    • hypersensitivity to ciprofloxacin (including other fluoroquinolones), tinidazole (including other imidazoles) or to any of the components of the drug;
    • blood diseases, oppression of bone marrow hematopoiesis;
    • acute porphyria, organic lesions of the nervous system;
    • concomitant use with tizanidine (risk of significant decrease in blood pressure and the onset of severe sleepiness);
    • children's age (up to 18 years);
    • pregnancy;
    • lactation period;
    • deficiency of lactase, lactose intolerance, glucose-galactose malabsorption.

    Carefully:
    The drug should be used with caution in patients with severe cerebral atherosclerosis, with disorders of cerebral circulation, syndrome congenital long QT interval with heart diseases (cardiac insufficiency, myocardial infarction, bradycardia), with electrolyte imbalance (e.g., hypokalemia, hypomagnesemia) while taking drugs prolonging the interval QT (in t. h. antiarrhythmics IA and class III), while the use of inhibitors of the CYP4501A2 (in m. hr. with eofillinom, methylxanthine, caffeine, duloxetine, clozapine), patients with mental illness, epilepsy with epileptic syndrome, renal and / or liver failure, with tendon lesions at the previously held treatment fluoroquinolones, old age.

    Pregnancy and lactation:
    Tinidazole can have a mutagenic and carcinogenic effect, so the use of the drug Tsifranv CT during pregnancy is contraindicated.
    Tinidazole and ciprofloxacin are excreted in breast milk, therefore the use of the drug Tsifran ST in the period of lactation is contraindicated.

    Dosing and Administration:
    Inside.
    The drug should be taken after eating, squeezed with enough water. Recommended dose for adults: 1 tablet 2 times a day.
    The duration of treatment depends on the severity of the disease, but the drug should always be continued for at least two more days after the disappearance of the symptoms of the disease. Usually the duration of treatment is 7-10 days.
    Table of recommended doses of the drug for patients with impaired renal function:
    Creatinine clearance Dose
    > 60 ml / min Correction of dose is not required
    30-60 ml / min 300 mg + 250 mg or 600 mg + 500 mg once every 12 hours

    <30 ml / min 300 mg + 250 mg or 600 mg + 500 mg once every 24 hours

    When prescribing a drug for elderly patients, it should be borne in mind that they may be more sensitive to the action of the drug due to delayed metabolism.
    With hemodialysis or peritoneal dialysis, the drug is used at a dose of 300 mg + 250 mg or 600 mg + 500 mg once every 24 hours,but the drug should be taken after a hemodialysis session.

    Side effects:
    On the part of the hematopoiesis system: leukopenia, granulocytopenia, anemia, thrombocytopenia, leukocytosis, thrombocytosis, hemolytic anemia, neutropenia, agranulocytosis, pancytopenia, oppression of bone marrow hematopoiesis, vasodilatation, serum sickness.
    From the side of the nervous system: headache, dizziness, vertigo, movement coordination disorders (including locomotion ataxia), gait disturbance, disorientation, fatigue, dysarthria, peripheral neuropathy, convulsions, weakness, tremor, insomnia, nightmarish dreams , anxiety, increased intracranial pressure, cerebral artery thrombosis, confusion, depression, hallucinations, as well as other manifestations of psychotic reactions (occasionally progressing to conditions in which the patient can cause damage), headache, fainting, agitation, dysesthesia, hyperesthesia, hypoesthesia, paresthesia, peripheral paralgeziya (anomaly feelings of pain perception), polyneuropathy.
    On the part of the respiratory system: breathing disorders (including bronchospasm).
    From the sense organs: the violation of taste and smell, visual impairment (diplopia, change in color perception, increased photosensitivity), tinnitus, hearing loss, hearing loss.
    From the cardiovascular system: tachycardia, cardiac rhythm disturbances, lowering of arterial pressure, prolongation of the QT interval on the electrocardiogram, ventricular arrhythmias (including the "pirouette" type).
    On the part of the digestive system: loss of appetite, dryness of the oral mucosa, "metallic" taste in the mouth, nausea, vomiting, diarrhea, abdominal pain, flatulence, cholestatic jaundice (especially in patients with liver disease), pancreatitis, hepatitis, hepatonecrosis .
    From the musculoskeletal system: arthralgia, arthritis, tendovaginitis, tendon ruptures, myalgia, increased muscle tone, muscle weakness, exacerbation of myasthenia gravis symptoms.
    From the urinary system: hematuria, crystalluria (with alkaline urine and decreased diuresis), glomerulonephritis, dysuria, polyuria, urinary retention, decreased renal nitrogen function, interstitial nephritis, renal failure.
    Allergic reactions: skin itching, urticaria, blistering,
    accompanied by bleeding, and small nodules that form scabs, drug fever, puncture of the face or larynx, shortness of breath, eosinophilia, vasculitis, erythema nodosum, multiforme exudative erythema (including Stevens-Johnson syndrome), toxic epidermal necrolysis (Lyell's syndrome), anaphylactic reactions, anaphylactic shock.
    On the part of laboratory indicators: hypoprothrombinemia, increased activity of amylase, "hepatic" transaminases, alkaline phosphatase, hypercreatininemia, hyperbilirubinemia, hyperglycemia.
    Other: asthenia, increased sweating, superinfection (candidiasis,
    pseudomembranous colitis), "tides" of blood to the skin of the face.

    Overdose:
    There is no specific antidote, so therapy with an overdose of Cyphran ® CT should be symptomatic and include the following measures:
    induce vomiting or gastric lavage;
    to take measures for adequate hydration of the body (infusion therapy);
    maintenance therapy.
    With the help of hemo- or peritoneal dialysis, the excretion of ciprofloxacin is insignificant (about 10%), but tinidazole can be completely eliminated from the body.
    Interaction:
    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).
    It is not recommended to administer with ethionamide.
    Phenobarbital accelerates metabolism.
    Compatible with sulfonamides and antibiotics (aminoglycosides, erythromycin, rifampicin, cephalosporins).
    Ciprofloxacin
    Due to a decrease in the activity of microsomal oxidation in hepatocytes ciprofloxacin increases the concentration and lengthens the half-life of theophylline (and other xanthines, for example, caffeine), oral hypoglycemic drugs, indirect anticoagulants, helps to reduce the prothrombin index.
    When ciprofloxacin is combined with other antimicrobial drugs (beta-lactam antibiotics, aminoglycosides, clindamycin, metronidazole), synergy is usually observed.
    Ciprofloxacin increases the nephrotoxic effect of cyclosporine, with an increase in serum creatinine, which requires monitoring of this parameter in patients 2 times a week.
    Oral administration of ciprofloxacin together with iron-containing drugs, sucralfate or antacid drugs containing magnesium, calcium, aluminum ions, leads to a decrease in absorption of ciprofloxacin, therefore it should be prescribed 1-2 hours before or 4 hours after the administration of the above medicines.
    Non-steroidal anti-inflammatory drugs in combination with ciprofloxacin increase the risk of seizures (except for acetylsalicylic acid). Didanosine reduces the absorption of ciprofloxacin due to the formation of complexes with ions of magnesium and aluminum in didanosine.
    Metoclopramide accelerates the absorption of ciprofloxacin, which leads to a decrease in the time to reach its maximum concentration (Stach).
    The joint administration of uricosuric medicines leads to a delay in excretion (up to 50%) and an increase in the plasma concentration of ciprofloxacin.
    When administered together with tizanidine, Stach Tizanidine in the blood increases by 7 times (from 4 to 21 times), resulting in such side effects of tizanidine, as a marked decrease in blood pressure and drowsiness.
    When used simultaneously with drugs that extend the QT interval (antiarrhythmic agents of IA and III classes), the QT interval can be extended on an electrocardiogram.
    With the simultaneous use of ciprofloxacin and omeprazole, there may be a slight decrease in the Stach of the drug in plasma and a decrease in the area under the concentration-time curve (AUC).
    The simultaneous use of probenecid and ciprofloxacin increases the concentration of ciprofloxacin in the blood plasma (probenecid slows the rate of excretion of ciprofloxacin by the kidneys).
    With simultaneous use with ciprofloxacin, renal metabolism of methotrexate may be slowed, which may be accompanied by an increase in the concentration of methotrexate in the blood plasma (the risk of side effects of methotrexate increases).
    The simultaneous use of duloxetine and potent inhibitors of the CYP4501A2 isoenzyme (such as fluvoxamine) can lead to an increase in AUC and Cmax of duloxetine.Despite the lack of clinical data on the possible interaction with ciprofloxacin, it is possible to foresee the likelihood of such interaction with the simultaneous use of ciprofloxacin and duloxetine.
    The simultaneous use of ropinirole and ciprofloxacin, a moderate inhibitor of the isoenzyme CYP4501A2, leads to an increase in Cmax and AUC of ropinirole by 60% and 84%, respectively. It is necessary to monitor the side effects of ropinirole during its combined use with ciprofloxacin and for a short time after completion of the combination therapy.
    With the simultaneous use of clozapine and ciprofloxacin at a dose of 250 mg for 7 days, an increase in serum concentrations of clozapine and N-desmethylclozapine by 29% and 31%, respectively, is possible. It is necessary to correct the dosage regimen of clozapine during its simultaneous application with ciprofloxacin and for a short time after the completion of the combination therapy. With the simultaneous use of ciprofloxacin in a dose of 500 mg and sildenafil at a dose of 50 mg, Cmax and AUC of sildenafil increased by a factor of 2 (this combination is possible only after assessing the benefit / risk ratio of therapy).Simultaneous use of lidocaine and ciprofloxacin leads to a decrease in lidocaine clearance by 22% when administered intravenously.

    Special instructions:
    Consider the possibility of cross-allergic reactions to tinidazole and ciprofloxacin in patients with hypersensitivity to other derivatives of imidazole and fluoroquinolone, respectively.
    During the treatment with Cyphran * ST, prolonged exposure to ultraviolet radiation should be avoided, including. prolonged exposure to direct sunlight, to avoid phototoxicity reactions.
    With the joint use of tinidazole with ethanol, painful spasms in the abdomen, nausea and vomiting can occur. The combined use of Tsifran ST and ethanol is contraindicated.
    To avoid the development of crystalluria, the recommended
    a daily dose, it is also necessary to have sufficient fluid intake and maintain an acidic urine reaction. Taking the drug causes a dark staining of urine (it has no clinical significance).
    Patients with epilepsy, seizures in the anamnesis, vascular diseases and organic brain lesions,in connection with the threat of development of adverse reactions from the central nervous system, the drug should be prescribed only according to "vital" indications.
    If a severe and prolonged diarrhea occurs during or after treatment, the diagnosis of pseudomembranous colitis should be deleted, which requires immediate discontinuation of the drug and the appointment of appropriate treatment.
    If pain occurs in the tendons or when the first signs of tendovaginitis appear, treatment should be stopped.
    During the treatment should monitor the picture of peripheral blood.


    Effect on the ability to drive transp. cf. and fur:

    Care should be taken when driving a car and engaging in other potentially hazardous activities requiring increased attention and speed of psychomotor reactions.
    Form release / dosage:
    Film-coated tablets, 600 mg + 500 mg.
    10 tablets in a blister of aluminum foil and PVC.
    1 or 2 blisters with instructions for use in a cardboard bundle.

    Packaging:
    10 tablets in a blister of aluminum foil and PVC.
    1 or 2 blisters with instructions for use in a cardboard bundle.
    Storage conditions:
    Store in a dry place at a temperature of no higher than 25 ° C.
    Keep out of the reach of children.

    Shelf life:
    2 of the year.
    Do not use after the expiration date.

    Terms of leave from pharmacies:On prescription
    Registration number:П N015922 / 01
    Date of registration:23.07.2008
    The owner of the registration certificate:Ranbaxy Laboratories LimitedRanbaxy Laboratories Limited India
    Manufacturer: & nbsp
    Representation: & nbspRABBAYS LABORATORY LIMITEDRABBAYS LABORATORY LIMITED
    Information update date: & nbsp05.09.2015
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