Norfloxacin

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Norfloxacin is a synthetic broad-spectrum fluoroquinolone antibiotic used primarily to treat bacterial infections. It works by inhibiting bacterial DNA gyrase and topoisomerase IV, enzymes essential for DNA replication, transcription, repair, and recombination, leading to bacterial cell death. Norfloxacin is effective against various Gram-negative and some Gram-positive bacteria and is commonly used in urinary tract infections, prostatitis, and gastroenteritis.

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Category: Active Pharmaceutical Ingredients (APIs) Tags: Antibacterial Agent, Broad-spectrum antibiotic, Fluoroquinolone Antibiotic, Norfloxacin

Description

Table of Contents

Norfloxacin

Primary Uses

Urinary Tract Infections (UTIs)
- Treatment of uncomplicated and complicated UTIs caused by susceptible bacteria.
- Effective against pathogens like Escherichia coli, Klebsiella, Proteus, and Pseudomonas.
Prostatitis
- Used in bacterial prostatitis caused by susceptible organisms, often requiring prolonged therapy.
Gastrointestinal Infections
- Treats bacterial diarrhea, including traveler’s diarrhea and infections caused by Shigella and Salmonella.
Sexually Transmitted Infections
- Effective against certain sexually transmitted infections caused by susceptible bacteria.

Secondary Uses

Respiratory Tract Infections
- Used off-label for bronchitis and pneumonia caused by susceptible bacteria in certain cases.
Bone and Joint Infections
- May be used adjunctively for osteomyelitis caused by susceptible bacteria.
Skin and Soft Tissue Infections
- Treatment option for infections when pathogens are sensitive and other agents are contraindicated.
Preventive Use in Surgery
- Occasionally employed for prophylaxis against infections in genitourinary surgeries.

KEY PRODUCT FEATURES

1. Basic Identification Attributes

Chemical Name (IUPAC): 1-Ethyl-6-fluoro-1,4-dihydro-4-oxo-7-(piperazin-1-yl)-3-quinolinecarboxylic acid
Common/Trade Name: Norfloxacin
CAS Number: 70458-96-7
HS Code: 2934.99.99 (Antibiotics, other than penicillins)
Synonyms: Noroxin, Norflox, Norcin

2. Physical & Chemical Properties

Physical State: White to off-white crystalline powder
Odor: Odorless or slight characteristic odor
Solubility: Sparingly soluble in water; soluble in dilute acids and alkali
Melting Point: 222–224°C
Molecular Formula: C16H18FN3O3

3. Safety & Hazard Attributes

GHS Classification: Harmful if swallowed; may cause serious eye irritation
Toxicity: Moderate toxicity; use under medical supervision
Exposure Limits: Not established; handle with appropriate PPE

4. Storage & Handling Attributes

Storage Conditions: Store in a cool, dry place protected from light
Container Type: Supplied in airtight containers or blister packs
Shelf Life: Typically 2–3 years under recommended storage
Handling Precautions: Use gloves and avoid inhalation of dust; prevent contamination

5. Regulatory & Compliance Attributes

Approved by major regulatory bodies such as FDA, EMA, and WHO for clinical use
Included in WHO Model List of Essential Medicines
Manufactured according to GMP standards

6. Environmental & Health Impact

Biodegradability: Moderate; should not be released untreated into environment
Ecotoxicity: May be toxic to aquatic organisms; avoid environmental contamination
Bioaccumulation: Low potential
Carcinogenicity/Mutagenicity: Not classified as carcinogenic; mutagenicity not observed at therapeutic doses

SAFETY HANDLING PRECAUTIONS

Safety Handling Precautions

PPE Required: Gloves, dust mask, and safety goggles recommended during handling
Handling Guidelines: Use in well-ventilated areas; avoid dust formation
Storage Measures: Keep containers tightly closed and away from incompatible substances

First Aid Measures

Inhalation: Move to fresh air; seek medical attention if symptoms develop
Skin Contact: Wash with soap and water; seek medical help if irritation occurs
Eye Contact: Rinse immediately with water for at least 15 minutes; consult a physician if irritation persists
Ingestion: Rinse mouth; do not induce vomiting; seek immediate medical attention

Firefighting Measures

Fire Hazards: Non-flammable
Extinguishing Media: Use water spray, foam, dry chemical, or CO₂ extinguisher
Special Precautions: Use standard protective equipment and self-contained breathing apparatus if necessary
Hazardous Combustion Products: Carbon oxides, nitrogen oxides