Cifran OD, 1000 mg 10 pcs

Intestinal infections, Cholecystitis, Skin infections, Infectious diseases, Osteomyelitis, Prostatitis, Urinary tract infections, Sinusitis, Respiratory tract infections, Lung inflammation (pneumonia)

According to rxlist.com (2020), oral ciprofloxacin is indicated to treat infections caused by sensitive strains of microorganisms.

Adult patients

. Skin and soft tissue infections caused by Escherichia coli, Klebsiella pneumoniae, Enterobacter cloacae, Proteus mirabilis, Proteus vulgaris, Providencia stuartii, Morganella morganii, Citrobacter freundii, Pseudomonas aeruginosa, methicillin-sensitive strains of Staphylococcus aureus, methicillin-sensitive strains of Staphylococcus epidermidis or Streptococcus pyogenes.

Bone and joint infections caused by Enterobacter cloacae, Serratia marcescens, Pseudomonas aeruginosa.

Complicated intra-abdominal infections (in combination with metronidazole) caused by Escherichia coli, Pseudomonas aeruginosa, Proteus mirabilis, Klebsiella pneumoniae or Bacteroides fragilis.

Infectious diarrhea caused by Escherichia coli (enterotoxigenic isolates), Campylobacter jejuni, Shigella boydii*, Shigella dysenteriae, Shigella flexneri, Shigella sonnei* when antibiotic therapy is indicated.

* Although treatment of infections caused by this microorganism in this organ system has demonstrated clinically significant results, efficacy has been studied in fewer than 10 patients.

Typhoid fever caused by Salmonella typhi. The efficacy of ciprofloxacin for eradication of the pathogen in chronic carriage has not been demonstrated.

Uncomplicated gonorrhea (cervical and urethral) caused by Neisseria gonorrhoeae.

Chronic bacterial prostatitis caused by Escherichia coli or Proteus mirabilis.

Infections of the lower respiratory tract

– Infections caused by Escherichia coli, Klebsiella pneumoniae, Enterobacter cloacae, Proteus mirabilis, Pseudomonas aeruginosa, Haemophilus influenzae, Haemophilus parainfluenzae or Streptococcus pneumoniae.

– Ciprofloxacin is not the drug of first choice in the treatment of suspected or confirmed pneumonia caused by Streptococcus pneumoniae.

– Treatment of exacerbations of chronic bronchitis caused by Moraxella catarrhalis.

Because the use of fluoroquinolones, including ciprofloxacin, is associated with a risk of serious adverse reactions (see Precautions), and in some patients exacerbations of chronic bronchitis are self-resolving, use for this indication is possible only if other treatments have been unsuccessful.

Urinary tract infections

– Urinary tract infections caused by Escherichia coli, Klebsiella pneumoniae, Enterobacter cloacae, Serratia marcescens, Proteus mirabilis, Providencia rettgeri, Morganella morganii, Citrobacter koseri, Citrobacter freundii, Pseudomonas aeroportixermoctiae. Staphylococcus saprophyticus or Enterococcus faecalis, in adults.

– Acute uncomplicated cystitis caused by Escherichia coli or Staphylococcus saprophyticus, in adult women.

Because the use of fluoroquinolones, including ciprofloxacin, is associated with a risk of serious adverse reactions (see Precautions), and acute uncomplicated cystitis is a self-resolving condition in some patients, use for this indication is possible only if other treatments have been unsuccessful.

Pediatric patients

Complicated urinary tract infections and Escherichia coli-induced pyelonephritis in pediatric patients aged 1 to 17 years.

Despite efficacy in clinical trials, ciprofloxacin is not the drug of first choice in pediatric patients because of increased rates of adverse reactions compared to controls, including joint and/or surrounding tissue reactions. Ciprofloxacin use, like other fluoroquinolones, is associated with arthropathy and histopathological changes in load-bearing joints in young animals (see Pharmacology and Toxicology in Animals).

Acute sinusitis caused by Haemophilus influenzae, Streptococcus pneumoniae or Moraxella catarrhalis.

Because the use of fluoroquinolones, including ciprofloxacin, is associated with a risk of serious adverse reactions (see Precautions), and acute sinusitis is a self-resolving condition in some patients, use for this indication is possible only if other treatments have been unsuccessful.

Adult and pediatric patients

Pulmonary anthrax (after exposure). Ciprofloxacin is indicated in adult and pediatric patients ages birth to 17 years for inhalational anthrax (after exposure) to reduce the incidence or progression of disease after exposure to Bacillus anthracis in aerosol form.

The ciprofloxacin concentrations achieved in human serum served as a surrogate endpoint reasonably predictive of clinical efficacy and served as the initial basis for approval of this indication.1 Confirmatory clinical information on ciprofloxacin for post-exposure anthrax prophylaxis was obtained during the October 2001 anthrax bioterror attacks (see Clinical Studies).

Plague, including pneumonic and septic plague caused by Yersinia pestis, and for the prevention of plague in adult and pediatric patients from birth to 17 years. A study of the efficacy of ciprofloxacin could not be conducted in plague patients. This indication is based on efficacy studies performed only on animals (see Clinical Studies).

Active ingredient

Composition

Active substance:

Ciprofloxacin – 1000 mg.

Auxiliary substances:

Sodium alginate (Keltone LVCR),

Hypromellose,

Sodium bicarbonate,

crospovidone (CLM),

magnesium stearate,

colloidal silicon dioxide (200),

talc.

Film coating:

Opadray white 31B58910*, talc, hypromellose, purified water , inscription ink black (Opacode-S-l-17823 black).

How to take, the dosage

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 per day; treatment duration is 1-2 weeks, and longer, if necessary. It is possible to administer by IV fluids, but drip infusion for 30 minutes is preferable.

When applied topically, 1-2 drops are placed into the lower conjunctival sac of the affected eye every 1-4 hours. The intervals between instillations may be increased after the condition improves.

The maximum daily dose for adults when taken orally is 1.5 g.

Interaction

Ciprofloxacin is an inhibitor of CYP1A2 isoenzyme of cytochrome P450. Concomitant use of ciprofloxacin with other drugs metabolized predominantly by CYP1A2 leads to increased plasma concentrations of these drugs and may lead to clinically significant adverse events.

Tizanidine. As a result of pharmacokinetic study with participation of healthy volunteers the concomitant administration of ciprofloxacin (500 mg 2 times daily for 3 days) and tizanidine (4 mg once daily) showed significant increase of tizanidine systemic exposure (Cmax by 7 times, AUC by 10 times). Simultaneous use of ciprofloxacin and tizanidine is contraindicated due to potentiation of hypotensive and sedative effects of tizanidine (see “Contraindications”).

Theophylline. Concomitant use of ciprofloxacin and theophylline may lead to an increased risk of adverse reactions in the patient, including CNS reactions. If concomitant use cannot be avoided, it is recommended to monitor theophylline serum concentrations continuously and to reduce theophylline dose if necessary (see “Precautions”).

Other xanthine derivatives. Concomitant use of ciprofloxacin and caffeine or pentoxifylline may result in decreased clearance, increased serum concentrations of xanthine derivatives and prolonged T1/2 from serum. Caution should be exercised and toxicity of xanthine should be monitored and the dose adjusted if necessary.

The drugs causing QT interval prolongation. Because ciprofloxacin may additionally prolong the QT interval, concomitant use of ciprofloxacin should be avoided in patients receiving drugs that prolong the QT interval (e.g., Class IA or Class III antiarrhythmic drugs, tricyclic antidepressants, macrolides, neuroleptics) (see “Precautions”).

Peroral hypoglycemic agents. Caution should be exercised when concomitant use of ciprofloxacin and oral hypoglycemic agents due to potentiation of the glucose-lowering effect. Severe hypoglycemia has been reported with concomitant use of ciprofloxacin and oral hypoglycemic agents, mainly sulfonylurea derivatives (e.g., glibenclamide, glimepiride). No fatal outcomes have been reported. Close monitoring of blood glucose levels is necessary (see “Side effects”).

Phenytoin. When concomitant use of ciprofloxacin and phenytoin, changes (increase or decrease) of phenytoin in blood serum have been observed. To avoid seizures associated with decreased phenytoin levels, and to prevent adverse events associated with phenytoin overdose when discontinuing ciprofloxacin, it is recommended to exercise caution and monitor phenytoin therapy in patients taking ciprofloxacin, including determination of serum phenytoin during the entire period of concurrent use and for a short time after completion of combined therapy.

Cyclosporine. When concomitant use of ciprofloxacin and cyclosporine, a transient increase in serum creatinine concentration has been observed. Caution should be exercised and renal function should be monitored (in particular, determination of blood creatinine concentration).

Anticoagulants. Concomitant use of ciprofloxacin and anticoagulants may lead to enhancement of their anticoagulant effect. The magnitude of this effect may vary depending on the infection, age and general condition of the patient, so it is difficult to assess the effect of ciprofloxacin on INR increase. Caution should be exercised and PV and INR should be monitored frequently when ciprofloxacin and oral anticoagulants (e.g., warfarin) are used together, and for a short time after completion of combined therapy.

Methotrexate. Concomitant use of methotrexate and ciprofloxacin may inhibit renal channel transport of methotrexate, which may be accompanied by increased plasma concentrations of methotrexate. This may increase the likelihood of side effects of methotrexate. Therefore, caution should be exercised: patients receiving methotrexate and ciprofloxacin concomitantly should be closely monitored.

Ropinirol. In a study involving 12 patients with Parkinson’s disease who received 6 mg of ropinirole once daily and 500 mg of ciprofloxacin twice daily, the Cmax and AUC of ropinirole were increased by 60 and 84%, respectively. Caution should be exercised when using ropinirole and ciprofloxacin concomitantly. It is recommended to monitor the side effects of ropinirole and adjust the dose accordingly when coadministered with ciprofloxacin and for a short time after completion of combined therapy.

Clozapine. When clozapine and ciprofloxacin were used concomitantly at a dose of 250 mg for 7 days, an increase in serum concentrations of clozapine and N-desmethylclozapine of 29 and 31%, respectively, was observed. Caution should be exercised, clozapine-associated adverse reactions should be closely monitored, and if necessary, the dosing regimen of clozapine should be adjusted during its co-administration with ciprofloxacin and for a short time after completion of combined therapy.

The NSAIDs. Combination of very high doses of quinolones and NSAIDs (excluding acetylsalicylic acid) may provoke seizures; use with caution.

Sildenafil. Simultaneous use in healthy volunteers of ciprofloxacin 500 mg and sildenafil in a single oral dose of 50 mg increased Cmax and AUC of sildenafil by approximately 2-fold. Therefore, caution and monitoring of sildenafil toxicity is necessary.

Duloxetine. In clinical trials it has been shown that concomitant use of duloxetine and strong CYP1A2 isoenzyme inhibitors (such as fluvoxamine) may increase AUC and Cmax of duloxetine by 5 and 2.5 times, respectively. Concomitant use of ciprofloxacin and duloxetine should be avoided. If this is not possible, monitoring of duloxetine toxicity is necessary.

Zolpidem. Concomitant use with ciprofloxacin may increase zolpidem blood levels, it is recommended to avoid concomitant use.

Probenecid. Probenecid slows down the rate of renal excretion of ciprofloxacin and increases its serum concentrations. Caution should be exercised when using ciprofloxacin and probenecid concomitantly (increased side effects of ciprofloxacin are possible).

Omeprazole. When using ciprofloxacin as a single dose of 1000 mg and omeprazole (40 mg once daily for 3 days) in 18 healthy volunteers AUC and Cmax of ciprofloxacin in blood were decreased by 20 and 23% respectively. The clinical significance of this interaction has not been determined.

Lidocaine. In a study involving 9 healthy volunteers, concomitant IV administration of lidocaine at a dose of 1.5 mg/kg and ciprofloxacin (500 mg twice daily) was shown to increase Cmax and AUC of lidocaine by 12 and 26%, respectively. Despite good tolerability of lidocaine, concomitant use with ciprofloxacin may lead to increased side effects due to interaction.

Histamine H2-receptor antagonists do not seem to have a significant effect on the bioavailability of ciprofloxacin.

Metronidazole. Serum concentrations of ciprofloxacin and metronidazole do not change when used concomitantly.

Methoclopramide. Metoclopramide significantly accelerates absorption of ciprofloxacin when administered orally, which shortens the time to reach Cmax in plasma. No significant effect on the bioavailability of ciprofloxacin was observed.

Cationic drugs. Simultaneous oral administration of ciprofloxacin and cationic drugs, such as multivitamins, magnesium- and aluminum-containing antacids, sucralfate, polymeric phosphate-binding compounds (e.g. sevelamer, lanthanum carbonate) and drugs with high buffer capacity (e.g. didanosine), mineral supplements containing calcium, iron, zinc – reduces absorption of ciprofloxacin, which leads to lower serum and urine levels.

The simultaneous use of antacids containing magnesium hydroxide or aluminum hydroxide may decrease the bioavailability of ciprofloxacin by 90%.

In the cases listed above, ciprofloxacin should be taken either 2 h before or 6 h after taking such medications.

Eating food and dairy products. Simultaneous oral administration of ciprofloxacin and dairy products or beverages enriched with minerals (e.g., milk, yogurt, calcium-enriched juices) should be avoided, since absorption of ciprofloxacin may be reduced. Calcium in regular foods has no significant effect on absorption of ciprofloxacin.

Special Instructions

Photosensitivity reactions have been observed in some patients receiving fluoroquinolones. Excessive exposure to direct sunlight and UV irradiation should be avoided. In case of photosensitivity reactions, it is recommended to discontinue the drug. Since Cifran® OD is a drug with possible reversible toxic effect on the kidneys, it is not recommended for use in patients with impaired renal function, with creatinine clearance of 29 ml/min or in patients under hemodialysis or peritoneal dialysis.

Pseudomembranous colitis, ranging in severity from mild to life-threatening, is possible with virtually all antimicrobials, including Cifran® OD. If severe and prolonged diarrhea occurs during or after treatment, the diagnosis of pseudomembranous colitis should be excluded, which requires immediate drug withdrawal and appropriate treatment.

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

Patients with a history of epilepsy, history of seizures, vascular disease and organic brain damage, due to the risk of CNS adverse reactions, Cifran® OD should be prescribed only for “vital” indications.

In case of tendon pain or if the first signs of tendovaritis appear, treatment should be stopped (there have been some cases of inflammation and even tendon rupture during treatment with fluoroquinolones).

At the time of treatment, it is necessary to refrain from potentially hazardous activities requiring high attention and rapid mental and motor reactions.

Contraindications

Side effects

The following serious and important adverse reactions are detailed in the “Precautions” section:

Loss of function and potentially irreversible serious adverse reactions (see “Precautions”);

Tendinitis and tendon rupture (see “Precautions);

– peripheral neuropathy (see Precautions);

– effects on the CNS (see Precautions. “Precautions);

– aggravation of myasthenia gravis (see Precautions);

– other serious and sometimes fatal reactions (see Precautions.

– hypersensitivity reactions (see “Precautions”);

– hepatotoxicity (see “Precautions”).

– risk of aortic aneurysm and dissection (see “Precautions”);

– serious adverse reactions with concomitant use of theophylline (see “Precautions”).

– diarrhea associated with Clostridium difficile (see “Precautions”);

– QT interval prolongation (see “Precautions”).

– musculoskeletal disorders in children (see “Precautions”);

– photosensitivity/photototototoxicity (see “Precautions”). “

– development of drug-resistant bacteria (see “Precautions”).

The results of clinical trials

Because clinical trials are conducted with a different set of conditions, the frequency of adverse reactions observed in these clinical trials may not be the same as those obtained in other clinical trials and observed in clinical practice.

Adult patients

In clinical trials of oral and parenteral forms of ciprofloxacin, 49038 patients were treated.

The most common adverse reactions reported in clinical trials (regardless of dosage, duration of therapy, or indication) were nausea (2.5%), diarrhea (1.6%), abnormal liver function tests (1.3%) ), vomiting (1%), and rash (1%).

The clinically important adverse reactions seen in <1% of patients when treated with ciprofloxacin are listed below.

The body in general: headache, pain, including abdominal pain/discomfort.

CCS: fainting, angina pectoris, myocardial infarction, cardiac and respiratory arrest, tachycardia, hypotension.

CNS side: anxiety, dizziness, sleep disturbance, nightmares, hallucinations, paranoia, psychosis (toxic), manic reaction, irritability, tremor, ataxia, seizures (including epileptic status), malaise, anorexia, phobia, depersonalization, depression (potentially leading to self-harming behaviors such as suicidal acts/thoughts and attempted or successful suicide), paresthesia, abnormal gait, migraine.

Gastrointestinal organs: intestinal perforation, gastrointestinal bleeding, cholestatic jaundice, hepatitis, pancreatitis.

Hematopoietic and lymphatic system disorders: petechiae.

Metabolism and nutrition disorders: hyperglycemia, hypoglycemia.

Motor system disorders: arthralgia, joint stiffness, muscle weakness.

Urogenital system disorders: interstitial nephritis, renal failure.

Respiratory system: dyspnea, laryngeal edema, hemoptysis, bronchospasm.

Skin side/hypersensitivity: Anaphylactic reactions, including potentially life-threatening anaphylactic shock, erythema multiforme/Stevens-Johnson syndrome, exfoliative dermatitis, toxic epidermal necrolysis, pruritis, urticaria, photosensitivity/photototoxicity reactions, blood rush to face, fever, angioneurotic edema, erythema nodosa, sweating.

Sense organs: blurred vision, visual disturbances (chromatopsia and photopsia), decreased visual acuity, diplopia, tinnitus, decreased hearing, loss of sense of taste.

Pediatric patients

. The short-term (6 weeks) and long-term (1 year) safety of ciprofloxacin with respect to the musculoskeletal and nervous systems when administered orally or by IV was compared with cephalosporin in the treatment of complicated urinary tract infections and pyelonephritis in pediatric patients aged 1 to 17 years (mean age (6±4) years) in an international multicenter study. The duration of therapy ranged from 10 to 21 days (mean duration of treatment was 11 days, ranging from 1 to 88 days). A total of 335 patients who received ciprofloxacin and 349 patients who received the comparison drug were included.

The Independent Pediatric Safety Committee (IPSC) reviewed all cases of adverse musculoskeletal reactions, including abnormal gait or joint abnormalities on physical examination (baseline or requiring treatment). At 6 weeks after treatment initiation, musculoskeletal adverse reactions were noted in 9.3% (31/335) of patients receiving ciprofloxacin compared with 6% (21/349) of patients receiving the comparison drug. All musculoskeletal adverse reactions occurring within 6 weeks resolved (clinical resolution of signs and symptoms) usually within 30 days of treatment completion. Radiological studies to confirm resolution of adverse reactions were not usually used. Patients who received ciprofloxacin were more likely to report more than one adverse reaction and more than one adverse reaction compared with control patients. The incidence of musculoskeletal side effects was consistently higher in the ciprofloxacin group compared with the control group in all age subgroups. At the end of 1 year, the incidence of these adverse reactions reported at any time during this period was 13.7% (46/335) in the ciprofloxacin group compared with 9.5% (33/349) in the comparison group, as shown in Table 2.

Table 2

Skeletal and musculoskeletal adverse reactions1 as assessed by IPSC

/p> Ciprofloxacin Comparison drug All patients (within 6 weeks) 31/335 (9.3%) 21/349 (6%) 95% CI2 (-0.8%, +7.2%) Age group 12-24 months 1/36 (2.8%) 0/41 2-6 years 5/124 (4%) 3/118 (2.5%) 6-12 years 18/143 (12.6%) 12/153 (7.8%) 12-17 years 7/32 (21.9%) 6/37 (16.2%) All patients (within 1 year) 46/335 (13.7%) 33/349 (9.5%) 95% CI2 (-0.6%, + 9.1%)

1 Adverse effects such as arthralgia, abnormal gait, abnormal joint condition on examination, sprained joints, leg pain, back pain, arthritis, bone pain, pain, myalgia, arm pain, and decreased range of motion in the joint (knee, elbow, ankle, hip, wrist, shoulder) were included.

2 The study was designed to demonstrate that the level of arthropathy in the ciprofloxacin group did not exceed that in the control group by more than + 6%. In both the 6-week and 1-year assessments, the 95% confidence CI showed that it could not be concluded that the ciprofloxacin group had comparable results to the control group.

The incidence of neurologic adverse reactions at 6 weeks from initiation of ciprofloxacin treatment was 3% (9/335) in the ciprofloxacin group compared with 2% (7/349) in the comparison group and included dizziness, nervousness, insomnia and somnolence.

In this study, the overall incidence of adverse reactions within 6 weeks of starting ciprofloxacin treatment was 41% (138/335) compared with 31% (109/349) in the comparison group. The most common adverse reactions were gastrointestinal, 15% (50/335) in patients treated with ciprofloxacin compared with 9% (31/349) in the comparison group.

Serious adverse reactions were seen in 7.5% (25/335) of patients receiving ciprofloxacin compared with 5.7% (20/349) of control group patients. Discontinuation of ciprofloxacin due to adverse effects was reported in 3% (10/335) of patients receiving ciprofloxacin compared with 1.4% (5/349) of comparison group patients. Other adverse reactions reported in at least 1% of patients receiving ciprofloxacin were diarrhea (4.8%), vomiting (4.8%), abdominal pain (3.3%), dyspepsia (2.7%), nausea (2.7%), fever (2.1%), asthma (1.8%) and rash (1.8%).

Short-term safety data for ciprofloxacin were also collected in a randomized, double-blind clinical trial in acute pulmonary exacerbations in patients with cystic fibrosis (ages 5 to 17 years). Sixty-seven patients received ciprofloxacin v/v at a dose of 10 mg/kg every 8 h for 1 week and then ciprofloxacin orally at a dose of 20 mg/kg every 12 h until completion of 10-21 days of treatment. Musculoskeletal evaluations were performed periodically by non-treatment experts. Patients were observed for an average of 23 days after completion of treatment (range 0-93 days). Musculoskeletal adverse reactions were reported in 22% of patients, decreased range of motion in 12% of patients, and arthralgia in 10% of patients. The efficacy of ciprofloxacin for the treatment of acute pulmonary exacerbations in pediatric patients with cystic fibrosis has not been established.

In addition to adverse reactions reported in pediatric patients in clinical trials, adverse reactions reported in adults during clinical trials or postmarketing experience should also be expected to occur in pediatric patients.

Postmarketing experience

The following are adverse reactions that have been reported with fluoroquinolones, including ciprofloxacin. Because these cases are reported voluntarily, from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

Systems side: prolongation of the QT interval, torsade de pointes, ventricular arrhythmias, vasculitis, hypertension.

CNS: myasthenia gravis, exacerbation of myasthenia gravis, peripheral neuropathy, polyneuropathy.

Visual disorders: eye twitching, nystagmus.

Gastrointestinal disorders: pseudomembranous colitis.

Hematopoietic and lymphatic system disorders: pancytopenia (life-threatening or fatal), methemoglobinemia.

Hepatic and biliary tract disorders: liver failure (including fatal cases).

Infections and invasions: candidiasis (oral, gastrointestinal, vaginal).

Studies: increased or decreased PV, increased cholesterol (serum), increased potassium (serum).

Musculoskeletal system: myalgia, myoclonus, tendinitis, tendon rupture.

Psychiatric disorders: agitation, confusion, delirium.

Skin disorders/hypersensitivity: acute generalized exanthematous pustulosis, fixed rash; serum-like reactions, anosmia.

Sensory organs: hyperesthesia, hypoesthesia, loss of taste.

Laboratory findings: hepatic – increased levels of ALT, AST, ALP, LDH, serum bilirubin; hematological – eosinophilia, leukopenia, decreased or increased levels of platelets, pancytopenia; renal – reported increases in serum creatinine, urea nitrogen, crystalluria, cylinduria and hematuria; Others – increased serum GGT levels, increased serum amylase levels, decreased blood glucose levels, increased uric acid levels, decreased Hb, anemia, bleeding diathesis, increased blood monocytes, and leukocytosis.

Overdose

Symptoms: in case of acute overdose, reversible renal toxicity has been reported in some cases.

Treatment: induction of vomiting, gastric lavage, administration of antacids containing magnesium, aluminum, calcium to reduce absorption of ciprofloxacin. Close monitoring of the patient’s condition and symptomatic therapy should be carried out, including monitoring of renal function, urine pH, and acidification if necessary, to prevent the development of crystalluria. Adequate fluid intake should be provided. Only a small amount (<10%) of ciprofloxacin may be excreted by hemo- or peritoneal dialysis.

Pregnancy use

Pregnancy

Risk summary. Long-term experience with ciprofloxacin use in pregnant women (over several decades), based on available published information from case reports, case-control studies, and observational studies, indicates no drug-associated risk of serious birth defects, miscarriage, or adverse outcomes for the mother or fetus.

The available studies cannot definitively establish the absence of risk because they have methodological limitations, including small sample sizes, and some are nonspecific for ciprofloxacin.

The oral administration of ciprofloxacin at doses up to 100 mg/kg to pregnant female mice and rats during organogenesis and at doses up to 30 mg/kg to pregnant rabbits did not cause fetal malformations. These doses were 0.3; 0.6 and 0.4 times higher than MRDH in mice, rats, and rabbits, respectively, in terms of body surface area.

The estimated background risk of serious birth defects and miscarriage in women is unknown. In any pregnancy, there is a background risk of developing a birth defect, miscarriage, or other adverse outcomes. In the general population in the United States, the estimated baseline risk of serious birth defects and miscarriage in clinically determined pregnancies is 2-4% and 15-20%, respectively.

Breastfeeding

Risk summary. The published literature reports that ciprofloxacin is present in breast milk after IV and oral administration. There is no information on the effects of ciprofloxacin on milk production or on the infant. Because of the potential risk of serious adverse reactions in breastfed infants, including arthropathy, as shown in studies in young animals, breastfeeding is not recommended during treatment with ciprofloxacin for most indications and for an additional 2 days (5 T1/2 periods) after the last dose.

But in inhalational anthrax (after exposure), an assessment of the risks and benefits of continued breastfeeding while the mother (and possibly the baby) is receiving ciprofloxacin is necessary. Consideration should be given to the developmental and health benefits of breastfeeding, the clinical necessity of the mother’s use of ciprofloxacin, and the potential for side effects in the breastfed infant.

Clinical Warnings

Ciprofloxacin may cause changes in the gut flora of the infant. It is recommended that the breastfed infant be monitored for liquid or bloody stools and candidiasis (thrush, diaper rash).

Similarities