Proxilev Dosage & Drug Information

Concise Prescribing Info Full Prescribing Info Contents Description Action Indications/Uses Dosage/Direction for Use Overdosage Special Precautions Use In Pregnancy & Lactation Adverse Reactions Drug Interactions Storage MIMS Class ATC Classification Regulatory Classification Presentation/Packing

Concise Prescribing Info

Contents

Ciprofloxacin

Indications/Uses

Severe infections of urinary & GI tracts including Campylobacter jejuni, Shigella spp or Salmonella spp; resp tract due to susceptible gm -ve bacteria including Pseudomonas aeruginosa. Susceptible STD eg, gonococcal (including penicillin resistant) & non gonococcal (chlamydial) urethritis. Osteomyelitis/septicemia caused by susceptible organisms including bacterial resistant to β-lactams. Multi-drug resistant typhoid fever; post-exposure prophylaxis for meningococcal disease & anthrax in adults.

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Dosage/Direction for Use

Adult Infusion time: 60 min for 400 mg IV infusion & 30 min for 200 mg IV infusion. Childn Infusion duration: 60 min.

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Overdosage

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Special Precautions

Hypersensitivity. Serious & anaphylactic reactions after 1st or subsequent doses. Discontinue at 1st sign of skin rash, jaundice or any sign of hypersensitivity. Hepatotoxicity. Discontinue immediately if signs & symptoms of hepatitis occur. Clostridium difficile-associated diarrhea. Evaluate if colitis occurs. QT prolongation; prolongation of QT interval & isolated cases of torsade de pointes. Avoid use in patients w/ known prolongation, w/ hypokalemia, & w/ other drugs that prolong QT interval. Increased risk of aortic aneurysm & dissection, particularly in elderly. Reserve use only when there are no alternative antibacterial treatments available in patients w/ known aortic aneurysm or who are at greater risk for aortic aneurysms. Avoid use during pregnancy. Not to be used during lactation.

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Use In Pregnancy & Lactation

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Adverse Reactions

Vomiting, transient increase in transaminases, rash.

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Drug Interactions

Interfered renal secretion & increased serum conc w/ probenecid. Increased serum tizanidine conc is associated w/ potentiated hypotensive & sedative effect. Renal tubular transport of MTX may be inhibited, potentially leading to increased plasma levels of MTX & increased risk of MTX-associated toxic reactions.

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Storage

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Description

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Action

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MIMS Class

Quinolones

ATC Classification

J01MA02 - ciprofloxacin ; Belongs to the class of fluoroquinolones. Used in the systemic treatment of infections.

Regulatory Classification

Presentation/Packing

Form

Proxilev soln for IV infusion 2 mg/mL (0.2% w/v)

Packing/Price

(bottle) 100 mL x 1's

Proxilev

ciprofloxacin

Manufacturer:

Unosource Pharma

Distributor:

HLM Pharma