Ciprodiazole 500/500 mg 20 tablets

Ciprodiazole 500/500 mg 20 tablets

Composition:

Each film-coated tablet contains Ciprofloxacin 500 mg and Metronidazole 500 mg.
Excipients include:
starch, sodium starch glycolate, povidone K30, lactose monohydrate 200, sodium lauryl sulfate, magnesium stearate, and vincoat green.

Product Description:

Ciprodiazole is a combination antimicrobial agent that unites the broad-spectrum antibacterial activity of ciprofloxacin (a fluoroquinolone) with the potent antiprotozoal and anaerobic coverage of metronidazole (a nitroimidazole derivative).
Ciprofloxacin inhibits bacterial DNA gyrase (topoisomerase II), preventing bacterial chromosome replication and protein synthesis in active and resting growth phases.
Metronidazole undergoes intracellular reduction in susceptible microorganisms, disrupting nucleic acid synthesis in anaerobic bacteria and protozoa, leading to rapid cell death.

Indications for Use:

• Mixed aerobic-anaerobic bacterial infections caused by microorganisms sensitive to ciprofloxacin and metronidazole.
• Intra-abdominal, gynecological, and pelvic infections.
• Severe skin, soft tissue, dental, and surgical wound infections.
• Protozoal and parasitic infections accompanied by bacterial co-infections.

Method of Administration and Dosage:

• The product is intended for oral administration.
• Tablets should be swallowed whole with a sufficient amount of water, without crushing or chewing.
• Adults over 18 years of age: The recommended dose is 1 tablet every 12 hours (twice daily). 
• Treatment duration is determined by the attending physician depending on clinical severity and underlying pathogen sensitivity.

Contraindications:

• Known hypersensitivity to ciprofloxacin, metronidazole, other fluoroquinolones or imidazole derivatives, or any of the excipients in the formulation.
• Glucose-6-phosphate dehydrogenase (G6PD) deficiency.
• History of pseudomembranous colitis or antibiotic-associated colitis.
• Organic central nervous system disorders (including epilepsy or low seizure threshold).
• Hepatic impairment when high-dose therapy is required.
• Pediatric patients under 18 years of age (prior to complete skeletal growth).
• Pregnancy.
• Breastfeeding (lactation) period.

Precautions:

• Concomitant ethanol or alcohol consumption is strictly contraindicated during therapy and for at least 48 hours following discontinuation due to the risk of disulfiram-like reactions (abdominal cramps, nausea, vomiting, flushing, and tachycardia).
• Hematological monitoring (complete blood count) is recommended during prolonged treatment courses. 
• If severe, persistent diarrhea occurs during or following treatment, pseudomembranous colitis must be excluded and therapy stopped immediately. 
• Discontinue medication at the first sign of tendon pain, inflammation, or tendinitis. 
• Maintain adequate systemic hydration and normal urine output during treatment.

Adverse Reactions / Side Effects:

Gastrointestinal Disorders: nausea, diarrhea, vomiting, abdominal pain, flatulence, anorexia; rarely — cholestatic jaundice (particularly in patients with prior liver disorders), hepatitis, hepatic necrosis.
Nervous System Disorders: dizziness, headache, fatigue, anxiety.
Skin and Subcutaneous Tissue Disorders: pruritus, urticaria, bullous hemorrhagic skin eruptions.

Pregnancy and Lactation:

Ciprodiazole 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 20 tablets and a medical instruction insert.