Cipromega 1 g XL 14 tablets
Mash Premiere for Pharmaceutical Industries
Mash Premiere for Pharmaceutical Industries
Composition
Ciprofloxacin hydrochloride 1164 mg, equivalent to Ciprofloxacin 1000 mg.
Excipients
Hydroxypropyl methylcellulose, Hydroxyethyl cellulose, Magnesium stearate, Colloidal silica anhydrous, Titanium dioxide, Polyethylene glycol 4000.
Drug description
A broad-spectrum fluoroquinolone antibacterial agent with bactericidal activity against susceptible strains causing urinary tract infections.
Indicated in adults for treatment of complicated and uncomplicated urinary tract infections, including acute pyelonephritis.
Indications for use
- Complicated urinary tract infections
- Acute uncomplicated pyelonephritis.
Dosage and administration
- Dose: 1000 mg once daily
- Duration: 7-14 days
- Tablets should be swallowed whole, not chewed or crushed
- Can be taken with food; avoid simultaneous intake of antacids, calcium-containing products, and mineral supplements (2–6 hour interval)
- For severe renal impairment (CrCl < 30 mL/min), the dose should be reduced to 500 mg once daily.
Contraindications
- Hypersensitivity to ciprofloxacin or other fluoroquinolones
- History of tendon disorders related to fluoroquinolones
- Concomitant use with agomelatine or tizanidine.
Precautions
- Caution in patients with aortic diseases or connective tissue disorders
- Monitor renal and liver function, electrolytes when comorbidities present
- Risk of phototoxicity and tendinopathy
- Monitor blood glucose in diabetic patients
- Use with caution in elderly and patients with CNS disorders.
Adverse effects
Common: nausea, diarrhea, headache (≥1%)
Uncommon: dry mouth, arthralgia, myalgia, peripheral neuropathy, photosensitivity, sleep disturbances, anxiety, depression, allergic reactions Very rare: tendon rupture, severe hypersensitivity reactions, hepatic failure, seizures, pseudomembranous colitis.
Pregnancy and breastfeeding
Pregnancy
Safety not established; use only if potential benefit outweighs risk.
Breastfeeding
Ciprofloxacin is excreted in breast milk; careful risk-benefit assessment required.
Storage conditions
Store below 30 °C in a dry, light-protected place.
Keep out of reach of children.
Packaging
Carton box containing 2 blisters of 7 tablets, leaflet.