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Cifran OD prolong tablets 1000 mg No. 10

Compound

Active substance: ciprofloxacin - 1000 mg.
Excipients: sodium alginate (Keltone LVCR), hypromellose, sodium bicarbonate, crospovidone (CLM), magnesium stearate, colloidal silicon dioxide (200), talc.

Film casing:

Opadry white 31B58910*, talc, hypromellose, purified water, black ink for writing (Opacode-Sl-17823 black).

Pharmacokinetics

Broad-spectrum antimicrobial agent of the fluoroquinolone group. Has a bactericidal effect. Suppresses 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 against Treponema pallidum has not been sufficiently studied.

Indications for use

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 complicated),

- chronic bacterial prostatitis,

- gonorrhea,

- intra-abdominal infections (including peritonitis, intra-abdominal abscesses, cholangitis, cholecystitis, gallbladder empyema) is used in combination with metronidazole

- infectious diseases of the skin,

— infectious diseases of bones and joints (including acute and chronic osteomyelitis),

- diarrhea of infectious origin - incl. traveler's diarrhea,

- typhoid fever,

- anthrax.

Contraindications

- pseudomembranous colitis,

- age up to 18 years,

- pregnancy,

- lactation period,

- hypersensitivity to ciprofloxacin or other drugs from the fluoroquinolone group,

- simultaneous use of tizanidine (risk of a pronounced decrease in blood pressure, drowsiness),

- chronic renal failure (creatinine clearance less than 29 ml/min, including patients on hemodialysis).

Carefully:

- severe cerebral atherosclerosis, cerebrovascular accident, mental illness,

- epilepsy,

- renal failure (creatinine clearance 35-50 ml/min),

- severe liver failure, advanced age,

— Tendon damage due to previous treatment with fluoroquinolones.

Directions for use and doses

Individually. Orally - 250-750 mg 2 times a day. The duration of treatment is from 7-10 days to 4 weeks.

For intravenous administration, a single dose is 200-400 mg, the frequency of administration is 2 times a day, the duration of treatment is 1-2 weeks, or more if necessary. It can be administered intravenously as a stream, but drip administration over 30 minutes is more preferable.

When applied topically, instill 1-2 drops 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.

Storage conditions

In a place protected from moisture, at a temperature not exceeding 25 C

Best before date

2 years

special instructions

Photosensitivity reactions have been observed in some patients receiving 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 Cifran OD is a drug with a possible reversible toxic effect on the kidneys, its use is not recommended for patients with impaired renal function and creatinine clearance

When using almost all antimicrobial drugs, including Tsifran OD, the development of pseudomembranous colitis is possible, varying in severity from mild to life-threatening. 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; it is also necessary to have sufficient fluid intake and maintain an acidic urine reaction.

For patients with epilepsy, a history of seizures, 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 health reasons.

If pain appears in the tendons or when the first signs of tendovarinitis appear, treatment should be stopped (individual cases of inflammation and even tendon rupture have been described during treatment with fluoroquinolones).

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

Side effects

From the digestive system: nausea, vomiting, diarrhea, abdominal pain, flatulence, anorexia, cholestatic jaundice (especially in patients with previous liver diseases), hepatitis, hepatonecrosis.

From the nervous system: dizziness, photophobia, insomnia, paresthesia, irritability, headache, fatigue, anxiety, tremor, nightmares, peripheral paralgesia (anomaly in the perception of pain), increased intracranial pressure, confusion, depression, hallucinations, and other manifestations of psychotic reactions (occasionally progressing to states in which the patient can harm himself), migraine, fainting, thrombosis of the cerebral arteries.

From the senses: disturbances of taste and smell, visual impairment (diplopia, changes in color vision), tinnitus, hearing loss.

From the cardiovascular system: tachycardia, heart rhythm disturbances, decreased blood pressure, flushing of the face.

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

Laboratory indicators: hypoprothrombinemia, increased activity of liver transaminases, hypercreatininemia, hyperbilirubinemia, hyperglycemia, increased activity of alkaline phosphatase and lactate dehydrogenase.

From the urinary system: hematuria, crystalluria (primarily with an alkaline urine reaction and low diuresis), acute interstitial nephritis (with the possible development of acute renal failure), glomerulonephritis, dysuria, polyuria, urinary retention, albuminuria, urethral bleeding, decreased nitrogen excretory function of the kidneys .

Allergic reactions: skin itching, urticaria, blistering accompanied by bleeding and the appearance of small nodules that form scabs, drug fever, pinpoint hemorrhages on the skin (petechiae), swelling of the face or larynx, shortness of breath, vasculitis, erythema nodosum, erythema multiforme exudative, malignant exudative erythema (Stevens-Johnson syndrome), toxic epidermal necrolysis (Lyell's syndrome).

From the musculoskeletal system: arthralgia, arthritis, tenosynovitis, tendon ruptures, myalgia.

Other: increased sweating, photosensitivity, general weakness, superinfections (candidiasis, pseudomembranous colitis).

Use during pregnancy and breastfeeding

Tsifran OD is not recommended for use during pregnancy.

Ciprofloxacin is excreted into breast milk, therefore, during lactation, if the use of Cifran OD is necessary, then, based on the degree of importance of its use for the mother, you should decide whether to stop taking the drug or breastfeeding.

Interaction

Due to inhibition of microsomal enzymes in the liver, it increases the concentration and prolongs T1/2 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 is reduced. Thus, the 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 drugs. Didanosine reduces the absorption of ciprofloxacin. This is due to the formation of complexes with magnesium salts contained in didanosine preparations.

When used together with probenecid and other drugs that block tubular secretion, the renal excretion of ciprofloxacin decreases.

Metoclopramide accelerates the absorption of the drug, which leads to a decrease in the time it takes to reach its Cmax.

Co-administration of uricosuric drugs leads to a slower elimination (up to 50%) and an increase in plasma concentrations of ciprofloxacin.

When combined with other antimicrobial drugs (beta-lactam antibiotics, aminoglycosides, clindamycin, metronidazole), synergism 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 serum creatinine concentration. 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 the blood plasma was noted.

Combined use with nonsteroidal anti-inflammatory drugs (NSAIDs) increases the likelihood of side effects of ciprofloxacin on the central nervous system (risk of seizures).

Absorption of ciprofloxacin when administered orally decreases after cytotoxic therapy with antitumor and immunosuppressive drugs.

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 symptomatic therapy:

- take measures to ensure adequate hydration of the body (infusion therapy),

— maintenance therapy.

Only trace amounts of ciprofloxacin (