Cipromet IV

Cipromet IV

ciprofloxacin

Manufacturer:

Metro Pharma

Distributor:

Metro Drug
Full Prescribing Info
Contents
Ciprofloxacin lactate.
Description
Each mL contains Ciprofloxacin (as lactate) equivalent to Ciprofloxacin 2 mg.
Indications/Uses
Ciprofloxacin is indicated for the treatment of infections: Caused by microorganism: Esherichia coli, Shigella (Shigella flexneri, Shigella sonnel) Salmonella, Ciltrobacter, Klebsiella, Enterobacter, Serratia, Hafnia Proteus (Indole Positive and negative), Pseudomonas, Acinetobacter, Streptococcus, Chlamydia, Streptococcus, Corynebacterium, Clostridium, Bacteriodes.
Infections: Respiratory infections, auris, nasus, and sphagitis, mouth, tooth, genial inflammation, renal or urinary tract infections, genital infections including gonorrhea, gastrointestinal infections, biliation canal infections, bone and joint infections, soft tissue infections, gynecological and obstetrical infections, Septicemia, meningitis, peritonitis, ophthalmic infections.
Dosage/Direction for Use
The usual adult intravenous dose is 100-400 mg twice daily, given over 30-60 minutes as a solution containing the equivalent of 1-2 mg/mL.
For acute exacerbations of cystic fibrosis associated with Pseudomonas aeruginosa infection, a dose of 10mg/kg may be given by intravenous infusion, up to a maximum of 400mg twice daily.
For inhalation anthrax, a dose of 10 mg/kg may be given by intravenous infusion over 60 minutes 3 times daily, to a maximum of 400 mg 3 times daily.
Ciprofloxacin is not generally for other uses in children and adolescents but, if considered essential, doses of 4-8 mg/kg twice daily intravenously have been suggested.
Or as prescribed by the physician.
Contraindications
The drug is contraindicated in the following patients: Patients with a history of hypersensitivity to ciprofloxacin; Pregnant women and nursing mothers; Infants and children; Patients with epilepsy; Patients who have a history of rupture and inflammation of tendon, hypersensitivity related to quinolone antibacterials.
Warnings
It has been reported that tendon ruptures of Achilles tendon, shoulders, hands which cause disability or require a surgery. If a patient feels a pain, inflammation, tendon rupture, the administration should be discontinued and the patient should take a rest, avoid exercising until it is certain that the symptom is proven not to be a tendonitis or tendon rupture.
Special Precautions
The administration of the drug should be cautioned in patients with severe impairment of renal function; in patients with history cerebral seizure, the use of ciprofloxacin should be instituted after appropriate anticonvulsant therapy; the aged; patients with cerebral hemokinetic disorder; patients with impaired vein system.
General Precautions: Patients with disposition should receive counseling with respect of adverse effects, including seizure or other CNS effects.
If pain, inflammatory, tendon rupture occurs, the administration should be discontinued, and the patients consult with a physician, and take a rest until it is certain that the symptom is proven not to be a tendonitis or tendon rupture.
Use in children: Safety use in children has not been established and therefore its use in children is not recommended.
Use In Pregnancy & Lactation
Safety use during pregnancy and lactation has not been established and it should not be therefore administered.
Adverse Reactions
Shock: Rarely, shock may occur, it should therefore be observed sufficiently. If any symptom occurs, the administration should be discontinued and appropriate therapy instituted.
Skin: Rarely, muco-cutaneous-ocular syndrome (Stevens-Johnson syndrome), photosensitivity may occur, it should therefore be observe sufficiently. If they occur the administration should be discontinued.
Hypersensitivity: Rare cases of pharyngeal edema, facial edema, pruritus, flush, may occur. If they occur the administration should be discontinued.
Renal: Rarely, acute kidney failure, and occasionally, increased serum creatinine and BUN concentration may occur.
Hepatic: Rarely, jaundice, and occasionally, elevations in GOT, GPT, Al-P may occur, it should therefore observed sufficiently. If any symptom occurs, the administration should be discontinued and appropriate therapy instituted.
Hematologic: Occasionally, leukopenia, thrombocytopenia, eosinophilia, and rarely, decreased platelet count, oligochromemia, decreased hematocrit level may occur.
Digestive System: Rarely, severe colitis accompanied with hemafecia including pseudomembranous colitis, may occur. If abdominal pain, frequent diarrhea occurs, an appropriate therapy, such as discontinuation of the therapy, should be instituted. Occasionally, anorexia, diarrhea, gastric discomfort, vomiturition, vomiting, abdominal pain, abdominal distention, and rarely, stomatitis may also occur.
Central Nervous System: Occasionally, headache, dizziness and rarely, lingual numbness, drowsiness, tremor, visual disorder may occur.
Muscle: Myalgia, a sense of exhaustion, increased CPK, myocytosis of striated muscle accompanied with sudden ingravescence of renal function, which increases myoglobin in blood and urine may occur, it should therefore be cautioned.
Respiratory System: Interstitial pneumonia, accompanied with flush, dyspnea, disorder of chest X, eosinophilia, may occur. If these symptoms occur, the administration should be discontinued and appropriate therapy, including adenocortical hormone therapy, instituted.
Others: Rarely, arthralgia may occur.
Rare case of hypoglycemia by other new quinolone antibacterial has been reported (it occurs frequently in the elderly patients, especially, patients with renal impairment), it should therefore cautioned.
Seizure, somniopathy may occur.
In a foreign country, rare cases of tendon disorder, such as Achilles tendonitis, tendon rupture, have been reported, it should therefore observe sufficiently. If any symptom occurs, the administration should be discontinued and appropriate therapy instituted.
In animal studies (young dogs, young rats), dysarthrosis has been occurred.
In mass-dose administration (more than 750mg/time), crystalluria has been reported.
Drug Interactions
Concomitant administration of Ciprofloxacin in patients receiving a theophylline may result in higher and prolonged serum theophylline concentrations. If plasma theophylline concentrations are increased, concomitant use of Ciprofloxacin and a theophylline should be avoided if possible.
Concomitant use of Ciprofloxacin with ketoprofen may cause convulsion rarely it should therefore be avoided. Concomitant use of Ciprofloxacin with other phenylacetic acids group or propionic acid group anti-inflammatory agents (NSAIA) may also cause convulsion, it should therefore cautioned.
Concurrent administration of Ciprofloxacin with antacids containing magnesium, aluminum, or calcium with sucralfate or divalent and trivalent cautions such as iron may substantially interfere with the absorption of Ciprofloxacin, resulting in serum and urine levels considerably lower than desired.
Ciprofloxacin is associated with transient elevations in serum creatinine in patients receiving cyclosporine concomitantly.
Storage
Store at temperatures not exceeding 30°C. Protect from light.
MIMS Class
ATC Classification
J01MA02 - ciprofloxacin ; Belongs to the class of fluoroquinolones. Used in the systemic treatment of infections.
Presentation/Packing
Inj 2 mg/mL x 100 mL.
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