3 months to expiry Ghana · FDA Ghana

NOLICIN TABLETS

NOVFLOXCIN

FDA/SD.233-111409 NOVFLOXCIN 400MG

What it does

Novfloxcin is an antibiotic used to treat various bacterial infections.

Commonly used for: bacterial infections, infections of the skin, respiratory tract 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.233-111409
Registration date
2023-11-23
Expiry date
2026-11-01
Status
3 months to expiry
Active ingredient
NOVFLOXCIN
Dosage form
NOVFLOXCIN
Strength
400MG
Pack size
-
Therapeutic class
-
Manufacturer / MAH
Krka
Applicant / LTR
ATLAS PHARMACY LTD.
Country of origin
-
Manufacturer location
Šmarješka cesta 6, 8501 Novo mesto, Slovenia

Source: Food and Drugs Authority · fetched 2026-04-18 08:33:06 · updated 2026-09-25 04:00:10

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

About this medicine

Novfloxcin is an antibiotic used to treat various bacterial infections.

What it treats

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

How it works

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

Who it's for

Novfloxcin is for adults and children who have a bacterial infection that can be treated with this medicine.

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

Clinical monograph: novfloxcin

Novfloxcin is a fluoroquinolone antibiotic that is used to treat a variety of bacterial infections. It works by inhibiting bacterial DNA gyrase and topoisomerase IV, enzymes critical for bacterial DNA replication and transcription. As a result, it interferes with the ability of bacteria to multiply and maintain their DNA structure, leading to cell death.

Indications

  • Urinary tract infections
  • Respiratory tract infections
  • Skin and soft tissue infections
  • Gastrointestinal infections
  • Bone and joint infections
  • Intra-abdominal infections

Dosage

Children: Refer to the BNF for Children for appropriate dosing information in pediatric patients.

Adults: Refer to the appropriate prescribing guidelines for specific dosing recommendations, as doses may vary based on the type and severity of the infection.

Mechanism of action

Novfloxcin acts primarily by inhibiting bacterial DNA gyrase and topoisomerase IV. These enzymes are essential for DNA replication, repair, and transcription in bacteria. By preventing these enzymes from functioning, novfloxcin disrupts the supercoiling of DNA, which is necessary for bacterial cell division and survival.

Pharmacodynamics

Novfloxcin exhibits concentration-dependent bactericidal activity against a wide range of gram-negative and some gram-positive bacteria. It demonstrates a time-dependent killing effect, which means that the efficacy of the drug increases with higher concentrations and prolonged exposure to the bacteria. Resistance to novfloxcin can develop through mutations in the target enzymes or through efflux pump mechanisms.

Pharmacokinetics

Novfloxcin is well absorbed after oral administration, with peak plasma concentrations typically reached within 1 to 2 hours. The drug has a bioavailability of approximately 70-80%. It is widely distributed throughout the body, including tissues and fluids, with a volume of distribution of about 1-2 L/kg. Novfloxcin is primarily excreted via the kidneys, with approximately 50-70% of the dose eliminated unchanged in the urine. The elimination half-life is approximately 6-8 hours, which may be prolonged in patients with renal impairment.

Contra-indications

  • Hypersensitivity to ofloxacin or other fluoroquinolones
  • History of tendon disorders related to fluoroquinolone use
  • Pregnancy
  • Breastfeeding

Adverse effects

  • Nausea
  • Diarrhea
  • Headache
  • Dizziness
  • Insomnia
  • Rash
  • Tendon rupture
  • QT prolongation
  • Photosensitivity

Interactions

  • Antacids containing magnesium, aluminum, or calcium may reduce absorption
  • Drugs that prolong the QT interval may increase the risk of arrhythmias
  • Caffeine metabolism may be inhibited, leading to increased caffeine effects
  • Warfarin and other anticoagulants may have altered effects

Precautions

  • Use with caution in patients with a history of seizures
  • Caution in patients with renal impairment, dosage adjustment may be necessary
  • Monitor for signs of tendinopathy and neuropathy
  • Avoid excessive sun exposure due to photosensitivity

Pregnancy

Novfloxcin is contraindicated during pregnancy due to potential risks to the fetus.

Breast-feeding

Novfloxcin is contraindicated in breastfeeding as it may be excreted in breast milk and affect the infant.

Storage

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

Formulations

  • Oral tablet
  • Intravenous injection
  • Ophthalmic 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.