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CIPRO TRUST 500MG TABLETS (Each film coated tablet contains aprofloxaan USP 500mg

aprofloxaan

FDA/SD.255-124036 aprofloxaan 500mg

What it does

Aprofloxacin is a type of antibiotic used to treat bacterial infections.

Commonly used for: bacterial infections, infections of the skin, respiratory infections, urinary tract infections

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

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Registration & product details

Registration no.
FDA/SD.255-124036
Registration date
2025-12-31
Expiry date
2030-12-31
Status
Valid
Active ingredient
aprofloxaan
Dosage form
aprofloxaan
Strength
500mg
Pack size
-
Therapeutic class
-
Manufacturer / MAH
Centurion Laboratories
Country of origin
INDIA
Manufacturer location
Biotech Park, P-2, GIDC Savli, Manjusar, Gujarat 391776, India

Source: Food and Drugs Authority · fetched 2026-05-08 08:00:26 · updated 2026-10-30 04:00:07

Disclaimer: This information is sourced from Food and Drugs Authority (Ghana). Always consult a qualified healthcare professional before using any medication.

About this medicine

Aprofloxacin is a type of antibiotic used to treat bacterial infections.

What it treats

  • bacterial infections
  • infections of the skin
  • respiratory infections
  • urinary tract infections

How it works

Aprofloxacin works by stopping the growth of bacteria, helping your body to fight off the infection.

Who it's for

Aprofloxacin is for adults and children who have bacterial infections that can be treated with antibiotics.

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

Clinical monograph: aprofloxaan

Aprofloxacin is a fluoroquinolone antibiotic that is primarily used to treat bacterial infections. It exhibits broad-spectrum activity against a variety of Gram-negative and Gram-positive bacteria. Aprofloxacin is particularly effective against pathogens such as Escherichia coli and Staphylococcus aureus. It is indicated for various infections, including respiratory tract infections, urinary tract infections, and skin infections. Its mechanism of action involves the inhibition of bacterial DNA gyrase and topoisomerase IV, which are essential for DNA replication and transcription.

Indications

  • Bacterial infections
  • Respiratory tract infections
  • Urinary tract infections
  • Skin infections
  • Gastrointestinal infections

Dosage

Children: Refer to the BNF for Children for appropriate dosing guidelines in children.

Adults: Refer to the specific BNF for recommended dosing based on the type and severity of infection.

Mechanism of action

Aprofloxacin exerts its antibacterial effects by inhibiting bacterial DNA synthesis. It binds to the DNA gyrase and topoisomerase IV enzymes, interrupting DNA replication and transcription processes. This leads to the inability of bacteria to multiply and ultimately results in cell death.

Pharmacodynamics

Aprofloxacin exhibits concentration-dependent killing, meaning that the efficacy of the drug increases with higher concentrations. It has a post-antibiotic effect, where bacterial growth is inhibited even after drug concentrations fall below the minimum inhibitory concentration (MIC). Resistance mechanisms may include mutations in the target enzymes and efflux pump overexpression.

Pharmacokinetics

Aprofloxacin is well absorbed following oral administration, with bioavailability typically exceeding 80%. It is widely distributed throughout the body, including penetration into tissues and fluids. The drug is metabolized in the liver, and its elimination half-life ranges from 5 to 10 hours. Aprofloxacin is primarily excreted via the kidneys, with a significant portion of the dose being eliminated unchanged in the urine.

Contra-indications

  • Hypersensitivity to aprofloxacin or any of its components
  • History of tendon disorders related to fluoroquinolone use
  • Concurrent use of tizanidine
  • Severe hepatic impairment

Adverse effects

  • Nausea
  • Diarrhea
  • Headache
  • Dizziness
  • Tendon rupture
  • QT interval prolongation
  • Rash
  • Photosensitivity
  • Liver enzyme elevations

Interactions

  • Antacids containing magnesium or aluminum may reduce absorption
  • Nonsteroidal anti-inflammatory drugs (NSAIDs) may increase the risk of CNS stimulation
  • Warfarin may have increased anticoagulant effects when used concurrently
  • Corticosteroids may increase the risk of tendon damage
  • Drugs that prolong the QT interval should be used with caution

Precautions

  • Use with caution in patients with a history of seizures
  • Assess for risk factors for tendon rupture, especially in older adults
  • Monitor for signs of liver toxicity
  • Caution in patients with myasthenia gravis due to potential exacerbation of symptoms

Pregnancy

Aprofloxacin is classified as a category C drug. Animal studies have shown adverse effects on the fetus, but there are no adequate studies in pregnant women. The drug should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

Breast-feeding

Aprofloxacin is excreted in human milk. Caution should be exercised when administering to a breastfeeding woman, as it may affect the nursing infant.

Storage

Store at room temperature, away from moisture and light. Keep all medications out of the reach of children.

Formulations

  • Tablets
  • Injectable solution

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