CIPAD 500 Ciprofloxacin Tablets USP 500 mg
Description, Pharmacology and pharmaco-kinetics, Absorption, Mechanism of action, Resistance, Indications, Contraindications, Drug interactions, Side effects, Dosage, Warning, Storage, Packing, Shelf life, NAFDAC Registration number, Owner and Manufacturer of Cipad 500 Tablet Medicine for Infections.
Only for the use of Registered Medical Practitioners or a Hospital or a Laboratory.
Each film coated tablet contains:
Ciprofloxacin Hydrochloride USP equivalent to Ciprofloxacin 500 mg
PHARMACOLOGY AND PHARMACO-KINETICS
Ciprofloxacin is a fluoroquinolone anti-bacterial agent with a wide spectrum activity including Enterobacteria, P. aeruginosa, Haemophilus and Neisseria spp. and also against Staphylococci and other gm +ve bacteria.
Ciprofloxacin hydrochloride, after oral administration, is rapidly absorbed from the G.l. tract. Mean peak serum concentration after a single oral dose of 500 mg of CIPAD is between 1.51 and 2.77 mg/l. Maximum serum concentrations are attained between 1 to 2 hours, after oral administration. Presence of food and milk in the G.I. tract may increase the rate but not the extent of absorption. Concurrent oral administration of antacids containing Magnesium, Aluminium or Calcium compounds decrease the bioavailability of Ciprofloxacin. Products containing Iron, Zinc and multivitamins should not be concurrently taken with Ciprofloxacin.
After oral administration, Ciprofloxacin is widely distributed throughout the body. Tissue concentration often exceeds serum concentration in both men and women, particularly in Genital tract, including prostate. Ciprofloxacin is present in active form in saliva, nasal and bronchial secretions, sputum, skin blister fluid, lymph, peritoneal fluid, bile and prostatic secretion. Ciprofloxacin has also been detected in lungs, skin, fat, muscle cartilage and bone. The drug diffuses into CSF, however CSF concentrations are generally less than 10% of peak serum concentration.
MECHANISM OF ACTION
The bactericidal action of Ciprofloxacin results from interference with the enzyme DNA gyrase belonging to a group of known as DNA topoisomerase, which is needed for the synthesis of bacterial DNA. The two strands of double-helical DNA must be separated to permit DNA replication or transcription.
Resistance to Ciprofloxacin, in vitro, develops slowly (multipe step mutation). Rapid one step development (Plasmid mediated) of resistance has not been observed. Ciprofloxacin does not cross-react with other multi-microbial agent, such as β-lactamase or aminoglycosides; therefore organisms resistant to these drugs may be susceptible to Ciprofloxacin. Only partial cross-resistance can occur between Ciprofloxacin and other quinolones.
1. Urinary Tract Infections.
2. Enteric Infections.
3. Skin and Soft Tissue Infections.
4. Bone and Joint Infections.
5. Sexually Transmitted Diseases (STD).
6. Respiratory Tract Infections.
7 Prophylaxis against infections in Granulocytopenic patients.
Ciprofloxacin is contra-indicated in patients with hypersensitivity to Quinolones.
DO NOT USE IN CHILDREN BELOW 18 YEARS.
DO NOT USE IN PREGNANCY AND LACTATION.
CIPAD increases plasma concentration of Theophylline. Concurrent administration of CIPAD with antacids containing Magnesium, Aluminium or Calcium with Sucralfate may substantially interfere with the absorption. Hence such agents should not be used concomitantly with or within 4 hours of CIPAD dose. Iron and probably Zinc interact in the similar manner. The proposed mechanism of interaction being chelation. Quinolones have been reported to enhance the effects of oral anti-coagulant Warfarin or its derivatives.
Ciprofloxacin has a good safety record. Adverse effects are generally mild. Individuals may have hypersensitivity. Inform the doctor about any adverse reaction if occurs during the treatment.
Urinary tract infection: 250 – 500 mg twice daily.
Respiratory tract infection: 250 – 750 mg twice daily.
Other infections: 500 mg twice daily or as directed by the Physician.
Cipad (ciprofloxacin), like other fluoroquinolone antibiotics carry a risk for permanent peripheral neuropathy as well as increased risk of tendinitis and actual tendon ruptures which could lead to permanent disability. Fluoroquinolones also increase risk for acute liver toxicity (in patients above age 66), and destabilize blood sugar in diabetics.
They have also been associated with memory loss, psychosis, headaches, depression, anxiety, kidney failure, cardiovascular symptoms, nausea and vomiting, blindness and other health problems.
Store in a cool (not exceeding 30°C) dark place, protected from light.
Box of 10 x Blister strips of 10 Tablets.
NAFDAC Reg. No.: 04 – 6926
ALBERT DAVID LTD
15 Chittaranjan Avenue
Kolkata 700072, INDIA
JAWA INTERNATIONAL LTD
Plot 6, Abimbola Way
Isolo Industrial Estate
Isolo, Lagos, Nigeria.