Products information : CIPRO 750

CIPRO 750 750 mg Ciprofloxacin
 
Products technical sheet

Pharmaceutical form and Presentation

 Pharmaceutical form
Coated tablet
Presentation
Box of 14 tablets
M.A number:923 329 4

Pharmacological properties

 - Quinolone class antibiotic.
- Ciprofloxacin is a synthetic broad-spectrum antibacterial agent, belonging to the fluoroquinolone’s group. It has a potent bactericidal action resulting from its bacterial DNA-gyrase inhibition, which impeaches chromosomal DNA synthesis.

Composition

Ciprofloxacin……………………..…...……750mg
Excipients: microcrystallin cellulose, carboxymethylamidon sodium, magnesium stearate, opadry HP white ……….........................................................s.q

Therapeutic indications

 The indications of cipro 750 arise out from ciprofloxacin antibacterial action and pharmacokinetics characteristics.
They are limited in adults to the following affections:
-Gonococcal urethritis
-Complicated or not urinary tract infections (including prostatitis)
-Intestinal infections
-Bone and joints infections (relay treatment)
-ORL infections:
•chronic sinusitis
•over-infections of chronic otitis (all types) and of evacuation cavities
•pre-operative preparation (surgery of chronic otitis, osteitis and of cholesteatoma)
•relay treatment of malignant external otitis
-Bronchial suppurations, excepted those due to pneumococci., and mainly when gram negative germs are suspected:
•In risky patients (chronic ethylism, smoking, 65 years and more, immunodepression)
•Chronic bronchitis: in repeated crisis
•In patients with mucoviscidosis
-Serious gram negative germs or sensitive staphylococci infections affecting the urinary and genital tract, including prostate and pelvis, bones and joints, intestines, hepato-biliar tract, skin. ORL and respiratory tract.

Contraindications

 Absolute:
- Patients with tendinopathy history due to fluoroquinolones.
- Hypersensitivity to ciprofloxacin or to any other quinolone.
- Children under 6 years
Relative:
- Children in their growth period.

Warnings and precautions of use

 Special warnings
-Avoid sun and UV exposure because of the photosensitization risk.
-Tendonitis, rarely observed, can lead to tendon rupture, particularly of Achilles tendons which seems to be favoured by long term corticotherapy. The risk of an unexpected arthropathy occurrence, especially in children, should be monitored.
Precautions of use
-Tendinitis: occurrence of tendonitis symptoms requires the immediate discontinuation of treatment, and the immobilization of the 2 Achilles tendons with an appropriate contention or heel pads. A specialized advice is required.
-Occurrence of joints pains during ciprofloxacin treatment, particularly in children, should be taken in account and treatment discontinued immediately. The joint should be immobilized and a special advice and treatment required.
-Ciprofloxacin should be used with precautions in patients presenting convulsions history or predisposing factors to convulsions.
-Ciprofloxacin should be used with precautions in patients presenting myasthenia.

Pregnancy and breastfeeding

 Pregnancy
The use  of ciprofloxacin in pregnant women is not recommended
Breastfeeding
Because of excretion of ciprofloxacin in mother’s milk, the administration of ciprofloxacin makes breastfeeding contraindicated.

Drugs interactions

 Requiring precautions of use:
-Oral anticoagulants (described with warfarine): increase of the oral anticoagulant effect and the hemorrhagic risk
-Theophyllins (base and salts) and aminophyllin: increase in theophyllinemia and risk of overdosage in theophyllin.
-Ropinirole: increase in plasmatic concentrations of ropinirole and risk of overdosage.
To be taken into account:
Caffeine: increase of caffeine level in the body (decrease in hepatic metabolism of caffeine)

Undesirable effects

 Gastro-intestinal disorders, cutaneous reactions (maculo-papular rash ), loco-motor system affections (muscle and joints pains and/or arthritis, rare cases of tendonitis and Achilles tendons rupture, neurological manifestations (convulsions, headaches), renal impairment (crystalluria), allergic manifestations (urticaria), hematological disorders (leucopenia, thrombocytopenia, hypereosinophilia), hepatic disorders (transaminases, alkaline phosphatases and biluribin increases)

Dosage and mode of administration

 Cipro tablets can be prescribed initially or subsequently after I.V administration, according to patient’s state.
Dosage depends on indication, severity and type of infection, causal germ sensitivity and patient’s weight.
In patients with renal impairment the dosage should be adjusted according to creatinine clearance levels or to creatininemia.
Adults with normal renal function
- Gonococcal urethritis: 250mg in a single intake.
- Non complicated low urinary tract infections: 250mg twice a day
- complicated or not low and upper urinary tract infections (including prostatitis), joints and bones infections relaying the injectable treatment, intestinal infections, bronchial suppuration according to the therapeutic indications, sinusitis and chronic otitis, malignant external otitis (treatment duration must be not less than 1 to 2 months), severe infections caused by gram negative bacillus and sensitive staphylococci in their renal and uro-genital (including prostatitis), pelvic, gynaecological, intestinal, hepato-biliar, joints and bones, cutaneous, ORL and respiratory localizations: 500 to 750mg twice a day
In patients with renal impairment
In patients with renal impairment (creatinin clearance < 30ml/min./1.73m2) and in those undergoing hemodialysis or peritoneal dialysis: 500 to 750 mg once a day
In patients with hepatic impairment with ascites
The initial dose should be reduced to the half: 500 to 750 mg once a day

Storage 

Store in a dry place keep away from heat and humidity.

Delivery conditions

 List I, table A, under medical prescription.