Composition
Active ingredient:
ciprofloxacin – 1000 mg.
Auxiliary substances:
sodium alginate (Keltone LVCR),
hypromellose,
sodium bicarbonate,
crospovidone (CLM),
magnesium stearate,
colloidal silicon dioxide (200),
talc.
Film shell:
opadray white 31 V 58910*, talc, hypromellose, purified water, black ink for the inscription (Opacode-S-l-17823 black).
Pharmacological action
Broad-spectrum antimicrobial agent of the fluoroquinolone group. It has a bactericidal effect. Inhibits DNA gyrase and inhibits bacterial DNA synthesis.
Highly active against most gram-negative bacteria: Pseudomonas aeruginosa, Haemophilus influenzae, Escherichia coli, Shigella spp., Salmonella spp., Neisseria meningitidis, Neisseria gonorrhoeae.
Active against Staphylococcus spp. (including strains that produce and do not produce penicillinase, methicillin-resistant strains), some strains of Enterococcus spp., Campylobacter spp., Legionella spp., Mycoplasma spp., Chlamydia spp., Mycobacterium spp.
Ciprofloxacin is active against bacteria that produce beta-lactamases.
Ureaplasma urealyticum, Clostridium difficile, and Nocardia asteroides are resistant to ciprofloxacin. The effect on Treponema pallidum has not been sufficiently studied.
Indications
of Cifran® OD is indicated for the treatment of the following infectious and inflammatory diseases caused by sensitive microorganisms.
– acute sinusitis;
– infectious and inflammatory diseases of the lower respiratory tract, including pneumonia, exacerbation of chronic bronchitis and infectious complications of cystic fibrosis;
– pyelonephritis, cystitis (including complex);
chronic bacterial prostatitis;
gonorrhoea;
– intra-abdominal infections (including peritonitis, intra-abdominal abscesses, cholangitis, cholecystitis, empyema of the gall bladder) is used in combination with metronidazole
is an infectious disease of the skin;
– infectious diseases of bones and joints (including acute and chronic osteomyelitis);
– diarrhea of infectious origin, including the “travellers ‘ diarrhoea”;
– typhoid fever;
– anthrax.
Use during pregnancy and lactation
Cifran® It is not recommended to use it during pregnancy.
Ciprofloxacin is excreted in breast milk, so during lactation, if the use of Cifran ® OD is necessary, then, based on the degree of importance of its use for the mother, it should be decided whether to stop taking the drug or breastfeeding.
Contraindications
– pseudomembranous colitis;
– age under 18 years;
– pregnancy;
– lactation period;
– hypersensitivity to ciprofloxacin or other drugs from the group of fluoroquinolones;
– concomitant use of tizanidine (risk of pronounced reduction in blood pressure, drowsiness);
– chronic renal failure (creatinine clearance less than 29 ml/min, including patients on hemodialysis).
With caution:
– severe cerebral vascular atherosclerosis; impaired cerebral circulation; mental illnesses;
– epilepsy;
– renal failure (creatinine clearance 35-50 ml / min);
– severe liver failure, elderly age;
– Tendon damage during previous treatment with fluoroquinolones.
Side effects
From the digestive system: nausea, vomiting, diarrhea, abdominal pain, flatulence, anorexia, cholestatic jaundice (especially in patients with previous liver diseases), hepatitis, hepatonecrosis.
Nervous system disorders: dizziness, photophobia, insomnia, paresthesia, irritability, headache, increased fatigue, anxiety, tremor, “nightmare” dreams, peripheral paralgesia (abnormal perception of pain), increased intracranial pressure, confusion, depression, hallucinations, etc. manifestations of psychotic reactions (occasionally progressing to conditions in which the patient can harm himself), migraine, fainting, cerebral artery thrombosis.
From the sensory organs: taste and smell disorders, visual disturbances (diplopia, color perception changes), tinnitus, hearing loss.
From the cardiovascular system: tachycardia, heart rhythm disorders, low blood pressure, “hot flashes” of blood to the skin of the face.
From the hematopoietic system: eosinophilia, leukopenia, granulocytopenia, anemia, thrombocytopenia, leukocytosis, thrombocytosis, hemolytic anemia.
Laboratory parameters: hypoprothrombinemia, increased activity of “hepatic” transaminases, hypercreatininemia, hyperbilirubinemia, hyperglycemia, increased activity of alkaline phosphatase and lactate dehydrogenase.
From the urinary system: hematuria, crystalluria (primarily with an alkaline reaction of Urine and low diuresis), acute interstitial nephritis (with the possible development of acute renal failure), glomerulonephritis, dysuria, polyuria, urinary retention, albuminuria, urethral bleeding, decreased nitrogen excretion function of the kidneys.
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, vasculitis, erythema nodosum, erythema multiforme, malignant exudative erythema (Stevens – Johnson syndrome), toxic epidermal necrolysis (syndrome Lyell).
Musculoskeletal disorders: arthralgia, arthritis, tendovaginitis, tendon tears, myalgia.
Other: increased sweating, photosensitivity, general weakness, superinfections (candidiasis, pseudomembranous colitis).
Interaction
Due to inhibition of microsomal enzymes in the liver, it increases the concentration and prolongs T 1/2 of theophylline and other xanthines (for example, caffeine), oral hypoglycemic drugs (for example, glibenclamide), indirect anticoagulants (for example, warfarin and its derivatives). If it is necessary to use it together with drugs of these groups, it is necessary to monitor the concentration of the drug in the blood and adjust the dosage regimen accordingly.
In the presence of antacids containing magnesium hydroxide or aluminum hydroxide, the absorption of ciprofloxacin decreases. Thus, simultaneous use of these drugs should be excluded. In such cases, ciprofloxacin should be taken either 1-2 hours before or 4 hours after taking these medications. Didanosine reduces the absorption of ciprofloxacin. This is due to the formation of complexes with magnesium salts contained in didanosine preparations.
When combined with probenecid and other drugs that block tubular secretion, renal excretion of ciprofloxacin decreases.
Metoclopramide accelerates the absorption of the drug, which leads to a decrease in the time to reach its Cmax.
Co-use of uricosuric drugs leads to a slowdown in excretion (up to 50%) and an increase in the plasma concentration of ciprofloxacin.
When combined with other antimicrobial drugs (beta-lactam antibiotics, aminoglycosides, clindamycin, metronidazole), synergy is usually observed; it can be successfully used in combination with azlocillin and ceftazidime for infections caused by Pseudomonas spp. ; with mezlocillin, azlocillin and other beta-lactam antibiotics – for streptococcal infections; with isoxazolylpenicillins and vancomycin – for staphylococcal infections; with metronidazole and clindamycin – for anaerobic infections.
Ciprofloxacin enhances the nephrotoxic effect of cyclosporine. There is an increase in the concentration of serum creatinine. In such patients, it is necessary to monitor this indicator 2 times a week.
Concomitant use of tizanidine with ciprofloxacin, which is an inhibitor of the CYP1A2 isoenzyme, leads to a 10-fold increase in the AUC of tizanidine. The result of combined use may be a clinically significant and prolonged decrease in blood pressure, leading to drowsiness, dizziness, and inhibited psychomotor reactions.
In patients receiving therapy with ciprofloxacin and phenytoin, variability (decrease or increase) in the concentration of phenytoin in blood plasma was noted.
Combined use with nonsteroidal anti-inflammatory drugs (NSAIDs) increases the likelihood of side effects of ciprofloxacin from the central nervous system (risk of seizures).
Oral absorption of ciprofloxacin decreases after cytotoxic therapy with antitumor and immunosuppressive drugs.
How to take it, course of use and dosage
Individually. Inside-250-750 mg 2 times/day. The duration of treatment is from 7-10 days to 4 weeks.
For intravenous use, a single dose is 200-400 mg, the frequency of use is 2 times/day; the duration of treatment is 1-2 weeks, if necessary, and more. It can be administered intravenously in a jet, but more preferably drip use for 30 minutes.
When applied topically,1-2 drops are instilled into the lower conjunctival sac of the affected eye every 1-4 hours. After the condition improves, the intervals between instillations can be increased.
The maximum daily dose for adults when taken orally is 1.5 g.
Overdose
Possible reversible toxic effects on the kidneys;
There is no specific antidote, so it is necessary to induce vomiting or perform gastric lavage and conduct symptomatic therapy. :
– carry out measures for adequate hydration of the body (infusion therapy);
– carrying out maintenance therapy.
Only minor amounts of ciprofloxacin (
Special instructions
Photosensitivity reactions were observed in some patients treated with fluoroquinolones. Excessive exposure to direct sunlight and UV radiation should be avoided. If a photosensitivity reaction occurs, it is recommended to stop using the drug. Since Tsifran® If OD is a drug with a possible reversible toxic effect on the kidneys, then it is not recommended to use it in patients with impaired renal function, with creatinine clearance
Pseudomembranous colitis, which can range in severity from mild to life-threatening, may occur with virtually all antimicrobial agents, including Cyfran ® OD. 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.
To avoid the development of crystalluria, it is unacceptable to exceed the recommended daily dose, as well as sufficient fluid intake and maintaining an acidic urine reaction.
Patients with epilepsy, seizures in the anamnesis, vascular diseases and organic brain lesions, due to the threat of adverse reactions from the central nervous system, Cifran® OD should be prescribed only for “vital” indications.
If tendon pain occurs or if the first signs of tendovarinitis appear, treatment should be discontinued (individual cases of inflammation and even rupture of tendons during treatment with fluoroquinolones have been described).
During treatment, you should refrain from engaging in potentially dangerous activities that require increased attention and speed of mental and motor reactions.
Form of production
Long-acting coated tablets.
Storage conditions
In a place protected from moisture, at a temperature not exceeding 25 °C
Shelf life
2 years
Active ingredient
Ciprofloxacin
Conditions of release from pharmacies
By prescription
Dosage form
Tablets
Purpose
For adults as directed by your doctor
Indications
Respiratory Tract Infections, Intestinal Infections, Cholecystitis, Sinusitis, Infectious Diseases, Prostatitis, Urinary Tract Infections, Skin Infections, Pneumonia, Osteomyelitis
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Side effects of Cifran OD, pills 1000mg, 10pcs.
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