Does Oflox (ofloxacin) contain sulphites?

Ofloxacin Does Not Contain Sulphites

Ofloxacin does not contain sulphites based on the FDA drug label information. 1

Chemical Composition of Ofloxacin

• Ofloxacin is a synthetic fluorinated carboxyquinolone with the chemical formula C₁₈H₂₀FN₃O₄ and molecular weight of 361.4 1
• The chemical structure of ofloxacin consists of a racemate, (±)-9-fluoro-2,3-dihydro-3-methyl-10-(4-methyl-1-piperazinyl)-7-oxo-7H-pyrido[1,2,3-de]-1,4-benzoxazine-6-carboxylic acid 1
• The FDA drug label lists all inactive ingredients in ofloxacin tablets as: lactose monohydrate, pregelatinized maize starch, hydroxy propyl methyl cellulose, talc, magnesium stearate, polyethylene glycol, sodium starch glycolate, and titanium dioxide 1
• The 200 mg and 400 mg tablets additionally contain iron oxide yellow, and the imprinting ink contains FD&C blue #1, isopropyl alcohol, N-butyl alcohol, propylene glycol, shellac and titanium dioxide 1

Pharmacological Properties of Ofloxacin

• Ofloxacin is a broad-spectrum antimicrobial agent that inhibits bacterial DNA gyrase, halting DNA replication 2
• It is well absorbed after oral administration with wide tissue and body fluid distribution 3
• Urinary excretion is the primary route of elimination, with 80% of the dose recovered in urine within 24 hours 3
• Ofloxacin has a serum half-life ranging between 2.9 and 9 hours in a dose-dependent manner 3

Clinical Applications

• Ofloxacin is used in the treatment of various infections including urinary tract infections, sexually transmitted diseases, and respiratory tract infections 4
• It is available in both oral and intravenous formulations, making it versatile for different clinical scenarios 5
• In sexually transmitted disease treatment guidelines, ofloxacin is listed as an alternative regimen for chlamydial infections at a dose of 300 mg orally twice a day for 7 days 6
• For gonococcal infections, ofloxacin 400 mg orally in a single dose is one of the recommended regimens 6

Important Considerations

• Ofloxacin is generally well-tolerated with most common adverse events being gastrointestinal and central nervous system reactions 3
• In patients with MDR-TB, later-generation fluoroquinolones like levofloxacin and moxifloxacin are preferred over ofloxacin due to their superior efficacy 6
• Permanent discontinuation of ofloxacin due to adverse events was reported in 4.8% of patients in a cohort study of MDR-TB patients 6
• Ofloxacin cannot be used during pregnancy or in persons less than or equal to 17 years of age 6

Conclusion on Sulphite Content

• The FDA drug label for ofloxacin clearly lists all inactive ingredients, and sulphites are not among them 1
• None of the available literature on ofloxacin mentions sulphites as components or preservatives in the formulation 7, 2, 3, 4, 5