Ciptid

Ciptid

ciprofloxacin

Manufacturer:

Stallion Labs

Distributor:

Ambica
Full Prescribing Info
Contents
Ciprofloxacin.
Description
Each 100 mL contains: Ciprofloxacin 200 mg, Sodium Chloride 9% w/v, Water for Injection Q.S.
Action
Pharmacotherapeutic group: Fluoroquinolones. ATC code: J01MA02.
Pharmacology: Pharmacodynamics: Mechanism of action: As a fluoroquinolone antibacterial agent, the bactericidal action of Ciprofloxacin results from the inhibition of both type II topoisomerase (DNA-gyrase) and topoisomerase IV, required for bacterial DNA replication, transcription, repair and recombination.
Spectrum of antibacterial activity: Breakpoints separate susceptible strains from strains with intermediate susceptibility and the latter from resistant strains: See Table 1.

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Pharmacokinetics: Absorption: Following an intravenous infusion of Ciprofloxacin the mean maximum serum concentrations were achieved at the end of infusion.
Pharmacokinetics of Ciprofloxacin were linear over the dose range up to 400 mg administered intravenously.
Comparison of the pharmacokinetic parameters for twice a day and three times a day intravenous dose regimen indicated no evidence of drug accumulation for Ciprofloxacin and its metabolites.
A 60-minute intravenous infusion of 200 mg Ciprofloxacin given every 12 hours, produced an equivalent area under the serum concentration time curve (AUC).
A 60-minute intravenous infusion of 400 mg Ciprofloxacin every 12 hours was bio-equivalent to a 500 mg oral dose every 12 hours with regard to AUC.
The 400 mg intravenous dose administered over 60 minutes every 12 hours resulted in a similar to that observed with a 750 mg oral dose.
A 60-minute infusion of 400 mg Ciprofloxacin every 8 hours is equivalent with respect to AUC to 750 mg oral regimen given every 12 hours.
Distribution: Protein binding of Ciprofloxacin is low (20-30%). Ciprofloxacin is present in plasma largely in a non-ionised form and has a large steady state distribution volume of 2-3 L/kg body weight. Ciprofloxacin reaches high concentrations in a variety of tissues such as lung (epithelial fluid, alveolar macrophages, biopsy tissue), sinuses, inflamed lesions (cantharides blister fluid), and the urogenital tract (urine, prostate, endometrium) where total concentrations exceeding those of plasma concentrations are reached.
Metabolism: Low concentrations of four metabolites have been reported, which were identified as: Desethyleneciprofloxacin (M 1), Sulphociprofloxacin (M 2), Oxociprofloxacin (M 3) and Formylciprofloxacin (M 4). The metabolites display in-vitro antimicrobial activity but to a lower degree than the parent compound.
Ciprofloxacin is known to be a moderate inhibitor of the CYP 450 1A2 iso-enzymes.
Elimination: Ciprofloxacin is largely excreted unchanged both renally and, to a smaller extent, facaelly.
Indications/Uses
Treatment of severe infections of the urinary and gastro-intestinal tracts including Campylobacter jejuni, shigella or salmonella; susceptible sexually transmitted diseases, e.g., gonococcal (including, penicillin resistant) and nongonococcal (chlamydial) urethritis, osteomyellitis/septicemia caused by susceptible organisms including bacteria resistant to beta lactams; severe infections of the respiratory tract due to susceptible Gram-negative infections including Pseudomonas aeruginosa; treatment of multi-drug resistant tuberculosis in combination with other drugs; treatment of multi-drug resistant typhoid fever; post-exposure prophylaxis for meningococcal disease and anthrax in adults.
Dosage/Direction for Use
The dosage is determined by the indication, the severity and the site of the infection, the susceptibility to ciprofloxacin of the causative organism(s), the renal function of the patient and, in children and adolescents the body weight.
The duration of treatment depends on the severity of the illness and on the clinical and bacteriological course.
After intravenous initiation of treatment, the treatment can be switched to oral treatment with tablet or suspension if clinically indicated at the discretion of the physician. IV treatment should be followed by oral route as soon as possible.
In severe cases or if the patient is unable to take tablets (e.g. patients on enteral nutrition), it is recommended to commence therapy with intravenous ciprofloxacin until a switch to oral administration is possible.
Treatment of infections due to certain bacteria (e.g. Pseudomonas aeruginosa, Acinetobacter or Staphylococci) may require higher ciprofloxacin doses and co-administration with other appropriate antibacterial agents.
Treatment of some infections (e.g. pelvic inflammatory disease, intra-abdominal infections, infections in neutropenic patients and infections of bones and joints) may require co-administration with other appropriate antibacterial agents depending on the pathogens involved.
Adults: See Table 2.

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Pediatric population: See Table 3.

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Elderly patients: Elderly patients should receive a dose selected according to the severity of the infection and the patient's creatinine clearance.
Patients with renal and hepatic impairment: Recommended starting and maintenance doses for patients with impaired renal function: See Table 4.

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In patients with impaired liver function no dose adjustment is required.
Dosing in children with impaired renal and/or hepatic function has not been studied.
Method of administration: Ciprofloxacin solution for infusion should be checked visually prior to use. It must not be used if cloudy.
Ciprofloxacin should be administered by intravenous infusion. For children, the infusion duration is 60 minutes.
In adult patients, infusion time is 60 minutes for 400 mg Ciprofloxacin solution for infusion and 30 minutes for 200 mg Ciprofloxacin solution for infusion. Slow infusion into a large vein will minimise patient discomfort and reduce the risk of venous irritation.
Contraindications
Hypersensitivity to the active substance, to other quinolones or to any of the excipients.
Concomitant administration of Ciprofloxacin and tizanidine.
Adverse Reactions
Common: Vomiting, Transient increase in transaminases, Rash.
Uncommon: Thrombocytopenia, Thrombocytaemia, Confusion and disorientation, Hallucinations, Par- and dysaesthesia, Seizures, Vertigo, Visual disturbances, Hearing loss, Tachycardia, Vasodilatation, Hypotension, Transient hepatic impairment, Cholestatic icterus, Renal failure, Oedema.
Rare: Pancytopenia, Bone marrow depression, Anaphylactic shock, Psychotic reactions, Migraine, Olfactory nerve disorders, Hearing impaired, Vasculitis, Pancreatitis, Liver necrosis, Petechiae, Tendon rupture.
Drug Interactions
Probenecid: Probenecid interferes with renal secretion of Ciprofloxacin. Co-administration of probenecid and Ciprofloxacin increases Ciprofloxacin serum concentrations.
Effects of Ciprofloxacin on other medicinal products: Tizanidine: Tizanidine must not be administered together with Ciprofloxacin. In a clinical study with healthy subjects, there was an increase in serum tizanidine concentration (Cmax increase: 7-fold, range: 4 to 21-fold; AUC increase: 10-fold, range: 6 to 24-fold) when given concomitantly with Ciprofloxacin. Increased serum tizanidine concentration is associated with a potentiated hypotensive and sedative effect.
Methotrexate: Renal tubular transport of methotrexate may be inhibited by concomitant administration of Ciprofloxacin, potentially leading to increased plasma levels of methotrexate and increased risk of methotrexate-associated toxic reactions. The concomitant use is not recommended.
Storage
Store at temperatures not exceeding 30°C.
MIMS Class
ATC Classification
J01MA02 - ciprofloxacin ; Belongs to the class of fluoroquinolones. Used in the systemic treatment of infections.
Presentation/Packing
Infusion 200 mg/100 mL x 100 mL x 1's.
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