products-page-bottom-left-box

Prox

Al-Tinez Pharmaceuticals Limited
9, Olowogbowo Str off Obokun Str by Coker Rd, Ilupeju, Lagos
Tel: 01-4826452; 0802-307-7320, 0803-305-7978

Brand Name

Prox

Manufacturer

Baroque Pharmaceuticals Pvt. Ltd, Sokhada-388 620, Ta. Khambhat, Gujarat, India. Mfg. Lic. No G/1217.

Therapeutic Class

Antibacterial, Quinolones

Dosage Form, Composition & NAFDAC Registration Number (NRN)

Tablet (NRN: 04-3565): Ciprofloxacin HCI (USP) 500 mg

How to Identify the Product: White and film coated oblong tablet.

Pack size: 2 x 7's.

Pharmacology

The bactericidal action of ciprofloxacin results from inhibition of the enzymes topoisomerase II (DNA gyrase) and topoisomerase IV (both Type II topoisomerases), which are required for bacterial DNA replication, transcription, repair, and recombination.

Indications

For the treatment of infections caused by susceptible strains of the designated microorganisms in the conditions listed below:

  • Lower respiratory infections by Escherichia coli, Klebsiella pneumoniae, Enterobacter cloacae, Proteus mirabilis, Pseudomonas aeruginosa, Haemophilus influenzae, Haemophilus parainfluenzae or Streptococcus pneumoniae.
  • Skin and soft structure infections caused by Escherichia coli, Klebsiella pneumoniae, Enterobacter cloacae, Proteus mirabilis, Proteus vulgaris, Providencia stuartii, Morganella morganii, Citrobacter freundii, Pseudomonas aeruginosa, Staphylococcus aureus, Staphylococcus epidermidis, or Streptococcus pyogenes.
  • Bone and joint infections caused by Enterobacter cloacae, Serratia marcescens, or Pseudomonas aeruginosa.
  • Urinary tract infections caused by Escherichia coli, Klebsiella pneumoniae, Enterobacter cloacae, Serratia marcescens, Proteus mirabilis, Providencia rettgeri, Morganella morganii, Citrobacter diversus, Citrobacter freundii, Pseudomonas aeruginosa, Staphylococcus epidermidis, or Enterococcus faecalis.
  • Infectious diarrhoea caused by Escherichia coli (enterotoxigenic strains), Campylobacter jejuni, Shigella flexneri or Shigella sonnei, when antibacterial therapy is indicated.

Contra-indications

Hypersensitivity to Ciprofloxacin or other quinolones.

Ciprofloxacin is also contra-indicated in children and growing adolescents except where the benefits of treatment exceed the risks.

Precautions/Warnings

Ciprofloxacin should be used with caution in epileptics and patients with a history of CNS disorders and only if the benefits of treatment are considered to outweigh the risk of possible CNS side-effects.

Ciprofloxacin could result in an impairment of the patient's ability to drive or operate machinery, particularly in conjunction with alcohol.

Crystalluria related to the use of ciprofloxacin has been reported patients receiving ciprofloxacin should be well hydrated and excessive alkalinity of the urine should be avoided.

Patients with latent or actual defects in glucose-6-phosphate dehydrogenase activity are prone to haemolytic reactions with quinolones, and so ciprofloxacin should be used with caution.

Interactions

Ciprofloxacin tablets should not be administered within 4 hours of medications containing magnesium, Aluminum or iron salts as interference with absorption may occur.

When appropriate, patients should be advised not to self-medicate with antacids or iron-containing preparations during therapy with ciprofloxacin.

Increased plasma levels of theophylline have been observed following concurrent administration with ciprofloxacin. It is recommended that the dose of theophylline should be reduced and plasma levels of theophylline monitored. Where monitoring of plasma levels is not possible the use of ciprofloxacin should be avoided in patients receiving theophylline. Particular caution is advised in those patients with convulsive disorders.

Prolongation of bleeding time has been reported during concomitant administration of ciprofloxacin and anticoagulants.

Adverse Effects

Ciprofloxacin is generally well tolerated. The most frequently reported adverse reactions are: Nausea, diarrhoea, vomiting, dyspepsia, abdominal pain, headache, restlessness, rash, dizziness and pruritus.

The following adverse reactions have been observed:

Gastro-intestinal disturbances: e.g. nausea, diarrhoea, vomiting, dyspepsia, abdominal pain, anorexia, flatulence, dysphagia. Rarely, pseudomembranous colitis, CNS disturbances, e.g headache, restlessness, depression, dizziness, tremor, convulsions, confusion, hallucinations, somnolence.  Very rarely, sleep disorders and anxiety states. There are isolated reports of intracranial hypertension associated with quinolone therapy.

Hypersensitivity reactions: such as skin rash, pruritus, urticaria, photosensitivity, drug induced liver disease, anaphylactic/anaphylactoid reactions.

Very rarely, petechiae, haemorrhagic bulluae, vasculitis, Stevens Johnson Syndrome and Lyell's Syndrome. Treatment with ciprofloxacin should be discontinued if any of the above occur upon first administration.

Hepatic disturbances: e.g. transient increases in liver enzymes or serum bilirubin (particularly in patients with previous liver damage), hepatitis, jaundice and major liver disorders including hepatic necrosis.

Renal disturbances: e.g. transient increases in blood urea or serum creatinine, renal failure, crystalluria and nephritis.

Musculoskeletal disturbances: e.g. arthralgia, myalgia. Rarely, tenosynovitis.

Effects on haematological parameters: e.g. eosinophilia, leucopenia, granulocytopenia. Thrombocytopenia, thrombocytosis altered prothrombin levels and very rarely, haemolytic anaemia.

Special sense disturbances: e.g. very rarely, visual disturbances, impaired taste and smell, tinnitus and transient impairment of healing, particularly at high frequencies.

Tachycardia has been reported.

Dosage & Administration

The usual adult dosage for patients with urinary tract infections is 250 mg every 12 hours. For patients with complicated infections caused by organisms not highly susceptible, 500 mg may be administered every 12 hours.

Lower respiratory tract infections, skin and skin structure infections, and bone and joint infections may be treated with 500 mg every 12 hours.

For more severe or complicated infections, a dosage of 750 mg may be given every 12 hours. The recommended dosage for infectious diarrhoea is 500 mg every 12 hours.

The duration of treatment depends upon the severity of infection. Generally ciprofloxacin should be continued for at least 2 days after the signs and symptoms of infection have disappeared. The usual duration is 7 to 14 days. However, for severe and complicated infections more prolonged therapy may be required.

Bone & joint infections may require treatment for 4 to 6 weeks or longer.

Infectious diarrhoea may be treated for 5-7 days.

Storage/Handling Recommendations

Store at room temperature. Keep out of the reach of children.

Review Date

2017-10-25 03:48:50