Ciprozid-DS 500 mg

Description

Indications
Ciprozid-DS is prescribed for the treatment of infections caused by one or multiple susceptible bacterial strains. It is particularly useful in cases where bacteria are resistant to other antibiotics, such as aminoglycosides, penicillins, and cephalosporins.

Pharmacology
Ciprofloxacin, the active ingredient in Ciprozid-DS, is a synthetic quinolone antibiotic with broad-spectrum antibacterial properties. It is effective against most Gram-negative aerobic bacteria, including Enterobacteriaceae and Pseudomonas aeruginosa, and also shows activity against some Gram-positive aerobic bacteria, such as penicillinase-producing and methicillin-resistant staphylococci. However, many strains of streptococci exhibit relative resistance to Ciprofloxacin. The bactericidal effect of Ciprofloxacin is achieved by inhibiting bacterial DNA gyrase, an enzyme essential for DNA replication. When administered orally, Ciprofloxacin is rapidly absorbed from the gastrointestinal tract, distributed widely throughout the body, and has a half-life of approximately 3.5 hours. Around 30% to 50% of the administered dose is excreted unchanged in the urine within 24 hours.

Dosage and Administration
The dosage of Ciprozid-DS varies based on the severity of the infection, the type of bacteria involved, and patient-specific factors such as age, weight, and renal function.

Adults:

• General infections: 100-750 mg twice daily.
• Urinary tract infections: 250-500 mg twice daily.
• Respiratory tract infections: 250-500 mg twice daily, increasing to 750 mg twice daily for Streptococcus pneumoniae infections.
• Gonorrhea: A single dose of 250-500 mg.
• Other infections: 500-750 mg twice daily.
• Cystic fibrosis with pseudomonal infections: 750 mg twice daily.

Patients with Impaired Renal Function:

• Dose adjustment may be necessary in cases of severe renal impairment (serum creatinine >265 micromol/L or creatinine clearance <20 mL/min). In such cases, reducing the total daily dose by half is recommended.

Elderly Patients:

• Although higher serum levels are observed in elderly patients, dosage adjustment is generally not required.

Children and Adolescents:

• Ciprofloxacin may cause joint disorders in growing children. Therefore, its use in pediatric patients is not recommended unless the benefits outweigh the risks. If prescribed, the dose ranges from 7.5-15 mg/kg/day, administered in two divided doses.

Duration of Treatment:

• Acute infections: Typically 5-10 days.
• Treatment should continue for at least three days after symptoms resolve.

Extended-Release Tablet:

• Uncomplicated urinary tract infections: 1000 mg once daily for three days.

Intravenous Infusion:

• Urinary tract infections: 200-400 mg every 12 hours for 7-14 days.
• Lower respiratory tract infections: 400 mg every 8-12 hours for 7-14 days.
• Nosocomial pneumonia: 400 mg every 8 hours for 10-14 days.
• Skin and soft tissue infections: 400 mg every 8-12 hours for 7-14 days.
• Bone and joint infections: 400 mg every 8-12 hours for 4-6 weeks or longer.
• Complicated intra-abdominal infections: 400 mg every 12 hours for 7-14 days.
• Acute sinusitis: 400 mg every 12 hours for 10 days.
• Chronic bacterial prostatitis: 400 mg every 12 hours for 28 days.

Administration Instructions for IV Infusion:

• Inspect the bag for leaks before use.
• Do not use if the solution appears cloudy or contains precipitates.
• Do not use flexible bags in series connections.
• Follow standard infusion administration procedures, ensuring proper fluid levels and flow rate adjustments.

Drug Interactions

• Avoid taking Ciprozid-DS with magnesium- or aluminum-containing antacids, sucralfate, or supplements containing calcium, iron, or zinc, as they can significantly reduce absorption. These products should be taken at least two hours after or six hours before Ciprozid-DS.
• Dairy products, such as milk or yogurt alone, should not be consumed with Ciprozid-DS, as they may hinder absorption. However, dietary calcium as part of a meal does not significantly affect absorption.

Contraindications

• Patients with known hypersensitivity to Ciprofloxacin or other quinolone antibiotics should not take Ciprozid-DS.

Side Effects

• Common gastrointestinal side effects include nausea, diarrhea, vomiting, dyspepsia, and abdominal pain.
• Central nervous system effects may include headache, dizziness, fatigue, confusion, convulsions, and an increased risk of retinal detachment.
• Hypersensitivity reactions such as skin rash, itching, and, in rare cases, Stevens-Johnson syndrome or toxic epidermal necrolysis.
• Other less common effects include joint pain, mild photosensitivity, and transient liver enzyme elevations, as well as increased serum bilirubin, urea, or creatinine levels.
• Possible risk of hypoglycemia and mental health-related adverse effects.

Pregnancy and Lactation

• Ciprofloxacin has not been found to be teratogenic in animal studies; however, due to its potential to cause joint disorders in immature animals, it is not recommended during pregnancy.
• Since Ciprofloxacin is excreted in breast milk, its use in nursing mothers is not advised.

Precautions and Warnings

• Use with caution in patients with CNS disorders, including arteriosclerosis and epilepsy, as Ciprozid-DS may increase the risk of seizures.
• Maintain adequate hydration while taking Ciprozid-DS.
• Avoid concurrent use with magnesium/aluminum antacids, sucralfate, and supplements containing calcium, iron, or zinc.
• Do not consume milk or yogurt alone with Ciprozid-DS, as this may impair absorption.

Use in Special Populations

• While effective in clinical trials, Ciprozid-DS is not a first-line treatment in pediatric patients.

Overdose Effects

• Overdose may cause neurological symptoms such as seizures and hallucinations, as well as gastrointestinal discomfort, renal and hepatic impairment, crystalluria, hematuria, and reversible kidney toxicity.

Therapeutic Class

• Ciprozid-DS belongs to the class of 4-quinolone antibiotics and antimicrobial agents used for diarrhea treatment.

Storage Conditions

• Store at temperatures below 30°C, protected from light and moisture.
• Keep out of reach of children.