Registered Malawi · PMRA

CIPROLEB-250 250MG TABLET

CIPROFLOXACILLIN HYDROCHLORIDE BP

PMPB/PL253/45 TABLET

What it does

Ciprofloxacillin is an antibiotic used to treat various bacterial infections.

Commonly used for: bacterial infections, urinary tract infections (UTIs), respiratory infections, skin infections

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Plain-language summary for general understanding - not medical advice. Always follow your pharmacist/doctor.

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Answers come only from this medicine's registration record, BNF monograph and interaction data - not medical advice.

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Registration & product details

Registration no.
PMPB/PL253/45
Registration date
18/01/2013
Expiry date
31/03/2025
Status
Registered
Active ingredient
CIPROFLOXACILLIN HYDROCHLORIDE BP
Dosage form
TABLET
Strength
-
Pack size
-
Therapeutic class
-
Manufacturer / MAH
-
Applicant / LTR
-
Country of origin
-

Source: Pharmacy and Medicines Regulatory Authority · fetched 2026-04-21 17:37:39 · updated 2026-09-29 04:33:04

Disclaimer: This information is sourced from Pharmacy and Medicines Regulatory Authority (Malawi). Always consult a qualified healthcare professional before using any medication.

About this medicine

Ciprofloxacillin is an antibiotic used to treat various bacterial infections.

What it treats

  • bacterial infections
  • urinary tract infections (UTIs)
  • respiratory infections
  • skin infections

How it works

It works by stopping the growth of bacteria, helping to eliminate the infection.

Who it's for

Ciprofloxacillin is for adults and children who have specific bacterial infections.

Cautions

  • • Consult a doctor if you have a history of tendon problems.
  • • Use with caution if you have kidney issues.

AI-assisted summary grounded in BNF data - general information only, not medical advice. Always confirm with your pharmacist or doctor.

Clinical monograph: ciprofloxacillin

Ciprofloxacin is a fluoroquinolone antibiotic that demonstrates broad-spectrum antimicrobial activity against a variety of Gram-negative and Gram-positive bacteria. It is commonly used to treat infections of the urinary tract, respiratory tract, gastrointestinal tract, and skin, as well as certain types of bacterial diarrhea. Ciprofloxacin works by inhibiting bacterial DNA gyrase and topoisomerase IV, which are essential for bacterial DNA replication, transcription, and repair.

Indications

  • Urinary tract infections
  • Respiratory tract infections
  • Gastrointestinal infections
  • Skin and soft tissue infections
  • Bone and joint infections
  • Intra-abdominal infections
  • Bacterial diarrhea
  • Typhoid fever

Dosage

Children: Refer to the BNF for Children for specific dosing recommendations in paediatric patients, tailored to the child's age and weight.

Adults: Refer to the appropriate clinical guidelines or BNF for specific adult dosing recommendations based on the type and severity of infection.

Mechanism of action

Ciprofloxacin acts primarily by inhibiting bacterial DNA gyrase and topoisomerase IV, enzymes critical for DNA replication and repair. This inhibition leads to the disruption of DNA synthesis, ultimately resulting in bacterial cell death. The drug exhibits concentration-dependent bactericidal activity, meaning that higher drug concentrations lead to greater antibacterial effects.

Pharmacodynamics

Ciprofloxacin displays a broad spectrum of activity against both aerobic Gram-negative and Gram-positive bacteria. Its bactericidal effect is enhanced in conditions of high drug concentration. The drug's activity is influenced by factors such as pH and the growth phase of the bacteria. Resistance mechanisms include mutations in the target enzymes and efflux pump overexpression.

Pharmacokinetics

Ciprofloxacin is well-absorbed following oral administration, with a bioavailability of approximately 70%. It is widely distributed in body tissues and fluids, including urine, bile, and respiratory secretions. The drug has a half-life of about 4 hours in healthy adults. Ciprofloxacin is primarily excreted unchanged in urine, with renal clearance being a significant route of elimination. Dose adjustments may be necessary in patients with renal impairment.

Contra-indications

  • Hypersensitivity to ciprofloxacin or any of the excipients
  • History of tendon disorders related to fluoroquinolone use
  • Concurrent use of tizanidine

Adverse effects

  • Nausea
  • Diarrhea
  • Vomiting
  • Rash
  • Headache
  • Dizziness
  • Tendon rupture
  • QT interval prolongation
  • Peripheral neuropathy
  • Clostridium difficile-associated diarrhea

Interactions

  • Antacids containing magnesium, aluminum, or calcium can reduce the absorption of ciprofloxacin
  • Concurrent use with warfarin may increase the risk of bleeding
  • Drugs that prolong the QT interval may enhance the risk of arrhythmias
  • Caffeine metabolism may be inhibited by ciprofloxacin, leading to increased effects

Precautions

  • Use with caution in patients with a history of seizures or epilepsy
  • Caution is advised in patients with renal impairment, as dose adjustment may be necessary
  • Monitor for signs of tendon pain and swelling, especially in the elderly
  • May cause photosensitivity; advise patients to avoid excessive sunlight

Pregnancy

Ciprofloxacin is not recommended during pregnancy due to potential risks to the fetus, particularly joint and cartilage damage.

Breast-feeding

Ciprofloxacin is excreted in breast milk; caution is advised when administering to nursing mothers.

Storage

Store at room temperature, away from moisture and heat. Keep out of reach of children.

Formulations

  • Oral tablets
  • Oral suspension
  • Intravenous infusion
  • Eye/ear drops

AI-synthesized from BNF references - general information only, not a substitute for professional medical advice or the current BNF. Verify doses with a pharmacist.