Ciprofloxacin 500 mg 10 tablets

Ciprofloxacin 500 mg 10 tablets

Composition:

Each film-coated tablet contains Ciprofloxacin 500 mg.
Excipients include:
croscarmellose sodium, colloidal silicon dioxide, magnesium stearate, microcrystalline cellulose, povidone K30, polyethylene glycol, hypromellose, and titanium dioxide.

Product Description:

Ciprofloxacin is a broad-spectrum fluoroquinolone antibacterial agent with potent bactericidal activity.
It acts by inhibiting bacterial DNA gyrase (topoisomerases II and IV), enzymes essential for chromosome supercoiling, DNA replication, transcription, and repair.
This mechanism disrupts bacterial cell wall integrity and protein synthesis, resulting in rapid bacterial cell death. It is active against a wide range of Gram-negative and Gram-positive aerobic and anaerobic pathogens.

Indications for Use:

Treatment of uncomplicated and complicated infections caused by ciprofloxacin-susceptible microorganisms, including urinary tract, respiratory tract, gastrointestinal, intra-abdominal, skin/soft tissue, bone/joint, and pelvic infections.

Method of Administration and Dosage:

• The medication is intended for oral administration.
• Dosing schedules should be individualized based on the clinical severity, type of infection, and patient age.
• Adults: Typically 250 mg to 750 mg twice daily. 
• Children and adolescents: 15 mg/kg to 20 mg/kg twice daily (maximum single dose 500 mg). 
• Tablets should be swallowed whole with a sufficient volume of water, with or without meals.

Contraindications:

• Known hypersensitivity to ciprofloxacin, other fluoroquinolones, or any of the excipients in the formulation.
• Concomitant administration of tizanidine (due to risk of severe hypotension and sedation secondary to elevated tizanidine plasma concentrations).
• Pregnancy.
• Breastfeeding (lactation) period.

Precautions:

• Severe hypersensitivity and anaphylactic reactions (including life-threatening anaphylactic shock) may occur even after a single initial dose; therapy should be discontinued immediately at the first sign of an allergic reaction.
• If severe, persistent diarrhea occurs during or following treatment, pseudomembranous colitis (Clostridium difficile-associated disease) must be considered. 
• In such cases, ciprofloxacin should be discontinued immediately, and appropriate targeted therapy (e.g., oral vancomycin 250 mg 4 times daily) initiated; antimotility/anti-peristaltic drugs are strictly contraindicated. 
• Fluoroquinolones may cause arthropathy and tendinopathy in pediatric populations and elderly patients.

Adverse Reactions / Side Effects:

• Gastrointestinal Disorders: common — nausea, diarrhea; uncommon — vomiting, abdominal pain, dyspepsia, flatulence; very rarely — pancreatitis.
• Musculoskeletal and Connective Tissue Disorders: common in pediatric patients — arthropathy (arthralgia, arthritis).
• Infections and Infestations: uncommon — mycotic superinfections; rarely — pseudomembranous colitis (potentially fatal in isolated cases).
• Blood and Lymphatic System Disorders: uncommon — eosinophilia.
• Immune System Disorders: uncommon — urticaria; rarely — allergic edema, angioedema; very rarely — anaphylactic reactions, anaphylactic shock, serum sickness.
• Eye, Ear, and Labyrinth Disorders: rarely — visual disturbances, tinnitus, hearing loss; very rarely — impaired color perception.

Pregnancy and Lactation:

Ciprofloxacin is strictly contraindicated during pregnancy and breastfeeding.
If administration becomes necessary during the lactation period, breastfeeding must be discontinued.

Storage Conditions:

Store at a temperature not exceeding 30 °C in a dry place.
Keep out of reach of children.

Packaging:

The cardboard box contains 10 tablets and a medical instruction insert.