Cifran ST, 500 mg+600 mg 10 pcs

Pharmacological action

Pharmacological action – broad spectrum antibacterial, bactericidal.

Indications

Treatment of mixed infections caused by sensitive anaerobic and aerobic microorganisms:

Chronic sinusitis;

Lung abscess;

Empyema;

Intra-abdominal infections;

inflammatory gynecologic diseases;

Postoperative infections (when aerobic and anaerobic bacteria may be present);

Chronic osteomyelitis;

Skin and soft tissue infections;

Diabetic foot ulcers;

Periosteal infections;

Infections of the oral cavity (including periodontitis and periostitis).

The treatment of diarrhea or dysentery of amebic or mixed (amebic and bacterial) etiology.

Active ingredient

Composition

1 coated tablet contains:

The active ingredients:

ciprofloxacin hydrochloride USP equivalent to ciprofloxacin – 500.00 mg,

tinidazole BP – 600 mg,

Excipients: microcrystalline cellulose, colloidal anhydrous silicon, magnesium stearate, sodium starch glycolate, sodium lauryl sulfate.

Incredibles of the outer layer of pellets: sodium starch glycolate, purified talc, sodium lauryl sulfate, microcrystalline cellulose, colloidal anhydrous silica, magnesium stearate.

Shell: opadrai yellow, purified water.

How to take, the dosage

To the mouth, after meals, with plenty of water.

The tablet should not be crushed, chewed or otherwise destroyed.

The recommended dose for adults

Cyfran® ST 250/300 mg is 2 tablets 2 times daily.

Cyfran® ST 500/600 mg – 1 tablet 2 times daily.

Interaction

Tinidazole

It increases 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 accelerates metabolism.

Ciprofloxacin

With decreased microsomal oxidation activity in hepatocytes increases the concentration and prolongs the T1/2 of theophylline (and other xanthines such as caffeine), oral hypoglycemic drugs, indirect anticoagulants and decreases the prothrombin index.

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

With increased nephrotoxic effects of cyclosporine, serum creatinine may increase; this should be monitored 2 times weekly in these patients.

In concomitant use increases the effect of indirect anticoagulants.

The oral administration together with iron-containing drugs, sucralfate and antacid drugs containing Mg2+, Ca2+, A13+ reduce absorption of ciprofloxacin, therefore it should be taken 1-2 hours before or 4 hours after taking the above mentioned drugs.

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

Didanosine decreases absorption of ciprofloxacin due to formation of complexes with Mg2+, A13+ contained in didanosine.

Methoclopramide accelerates absorption, which leads to a decrease in the time to reach its maximum concentration.

The co-administration of uricosuric drugs leads to slower excretion (up to 50%) and increased plasma concentration of ciprofloxacin.

Special Instructions

It is recommended that excessive exposure to sunlight during therapy with Cifran® ST be avoided because phototoxicity reactions have been reported in some patients treated with fluoroquinolones. If phototoxicity reactions occur, the drug should be discontinued immediately.

When using tinidazole it is possible (but rare) to develop generalized urticaria, facial and laryngeal edema, decreased blood pressure, bronchospasm and dyspnea. If a patient is allergic to any imidazole derivative, cross-sensitivity to tinidazole may also develop; cross-allergic reaction to ciprofloxacin may also develop in patients allergic to other fluoroquinolone derivatives. Therefore, if a patient had any allergic reactions to similar drugs, the possibility of cross-allergic reactions to Cifran® ST should be considered.

In co-administration of tinidazole with alcohol painful abdominal cramps, nausea and vomiting may occur. Therefore, co-administration of Cifran® ST and alcohol is contraindicated.

In order to avoid development of crystalluria, the recommended daily dose should not be exceeded; adequate fluid intake and maintenance of an acidic urine reaction are also required. Causes dark staining of urine.

At the time of treatment, you should refrain from engaging in potentially hazardous activities that require increased attention and rapid mental and motor reactions.

Physicians with epilepsy, history of seizures, vascular diseases and organic brain damage, due to the risk of CNS adverse reactions, the drug should be used only for vital signs.

In case of severe and prolonged diarrhea during or after treatment the diagnosis of pseudomembranous colitis should be excluded, which requires immediate withdrawal of the drug and appropriate treatment.

In case of tendon pain or the first signs of tendovaginitis, treatment should be discontinued.

The peripheral blood count should be monitored during treatment.

The safety and effectiveness for treatment and prevention of anaerobic infections in children under 12 years of age has not been established.

Contraindications

Side effects

Digestive system disorders: decreased appetite, dry mouth, “metallic” taste in the mouth, nausea, vomiting, diarrhea, abdominal pain, flatulence, cholestatic jaundice (especially in patients with previous liver diseases), hepatitis, hepatonecrosis.

CNS disorders: headache, dizziness, increased fatigue, movement coordination disorders (including locomotor ataxia), dysarthria, peripheral neuropathy, rarely seizures, weakness, tremor, insomnia, increased sweating, increased intracranial pressure, confusion, depression, hallucinations, as well as other manifestations of psychotic reactions, migraine, fainting states, cerebral artery thrombosis.

Sensory organs: disorders of taste and smell, visual disturbances (diplopia, change in color perception), tinnitus, decreased hearing.

Cardiovascular system disorders: tachycardia, heart rhythm disorders, decreased blood pressure.

Hematopoietic system disorders: leukopenia, granulocytopenia, anemia, thrombocytopenia, leukocytosis, thrombocytosis, hemolytic anemia.

Laboratory parameters: hypoprothrombinemia, increased liver transaminases and alkaline phosphatase activity, hypercreatinemia, hyperbilirubinemia, hyperglycemia.

Urinary system disorders: hematuria, crystalluria (with alkaline urine and low diuresis), glomerulonephritis, dysuria, polyuria, urine retention, decreased renal nitrogen excretion function, interstitial nephritis.

Allergic reactions: Pruritus, urticaria, blistering accompanied by bleeding and appearance of small nodules forming scabs, drug-induced fever, petechial skin petechiae, facial or laryngeal edema, shortness of breath, eosinophilia, increased photosensitivity, vasculitis, erythema nodosa, erythema multiforme exudative (includingStevens-Johnson syndrome), toxic epidermal necrolysis (Lyell syndrome).

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

Overdose

Treatment: therapy in case of overdose of Cifran® ST should be symptomatic and include the following measures:

– induction of vomiting or gastric lavage,

– measures for adequate hydration of the body (infusion therapy);

– supportive therapy.

There is no specific antidote.

Pregnancy use

The use during pregnancy is not recommended. Tinidazole may have carcinogenic and mutagenic effects. Ciprofloxacin penetrates through the blood-placental barrier.

The use is contraindicated during breastfeeding. Tinidazole and ciprofloxacin are excreted into the breast milk. Therefore, during lactation, if it is necessary to use the drug, breastfeeding should be stopped.

Similarities