INN monograph
Ciprofloxacin/Tinidazole
Fluoroquinolone antibiotic · POM
Source-linked · Updated 03 Aug 2026 · Source: Local active-ingredient clinical extract; FDA drug label via OpenFDA/DailyMed; Component monographs (multi-source pipeline); Professional class pharmacology (Fluoroquinolone antibiotic)
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Risk first
Contraindications
- CONTRAINDICATIONS A history of hypersensitivity to ciprofloxacin or any other component of the medication is a contraindication to its use.
- A history of hypersensitivity to other quinolones may also contraindicate the use of ciprofloxacin.
Precautions
- WARNINGS NOT FOR INJECTION INTO THE EYE.
- Serious and occasionally fatal hypersensitivity (anaphylactic) reactions, some following the first dose, have been reported in patients receiving systemic quinolone therapy.
- Some reactions were accompanied by cardiovascular collapse, loss of consciousness, tingling, pharyngeal or facial edema, dyspnea, urticaria, and itching.
- Only a few patients had a history of hypersensitivity reactions.
- Serious anaphylactic reactions require immediate emergency treatment with epinephrine and other resuscitation measures, including oxygen, intravenous fluids, intravenous antihistamines, corticosteroids, pressor amines and airway management, as clinically indicated.
- Remove contact lenses before using.
Point of care
Dosing
Adult
DOSAGE AND ADMINISTRATION Corneal Ulcers: The recommended dosage regimen for the treatment of corneal ulcers is two drops into the affected eye every 15 minutes for the first six hours and then two drops into the affected eye every 30 minutes for the remainder of the first day. On the second day, instill two drops in the affected eye hourly. On the third through the fourteenth day, place two drops in the affected eye every four hours. Treatment may be continued after 14 days if corneal re-epithelialisation has not occurred. Bacterial Conjunctivitis: The recommended dosage regimen for the treatment of bacterial conjunctivitis is one or two drops instilled into the conjunctival sac(s) every two hours while awake for two days and one or two drops every four hours while awake for the next five days.
Paediatric
Pediatric Use: The safety and effectiveness of Ciprofloxacin ophthalmic solution 0.3% have been established in all ages. Use of Ciprofloxacin ophthalmic solution is supported by evidence from adequate and well controlled studies of Ciprofloxacin ophthalmic solution in adults, children and neonates [ see Clinical Studies ]. Although ciprofloxacin and other quinolones cause arthropathy in immature animals after oral administration, topical ocular administration of ciprofloxacin to immature animals did not cause any arthropathy and there is no evidence that the ophthalmic dosage form has any effect on the weight bearing joints.
Renal
Many agents need CrCl-based adjustment (e.g. ciprofloxacin, levofloxacin).
- CrCl 0–120: Confirm renal dosing in product SmPC / primary label.
Hepatic
Hepatotoxicity uncommon but reported; moxifloxacin has more hepatic clearance.
Safety
Drug interactions
- Fixed-dose/multi-ingredient product.
- Clinical details partially inherited from component monographs: Ciprofloxacin, Tinidazole.
- Confirm combination SmPC for exact dosing.
Safety
Adverse effects
- ADVERSE REACTIONS The most frequently reported drug related adverse reaction was local burning or discomfort.
- In corneal ulcer studies with frequent administration of the drug, white crystalline precipitates were seen in approximately 17% of patients ( see Precautions ).
- Other reactions occurring in less than 10% of patients included lid margin crusting, crystals/scales, foreign body sensation, itching, conjunctival hyperemia and a bad taste following instillation.
- Additional events occurring in less than 1% of patients included corneal staining, keratopathy/keratitis, allergic reactions, lid edema, tearing, photophobia, corneal infiltrates, nausea and decreased vision.
- To report SUSPECTED ADVERSE REACTIONS, contact LEADING PHARMA AT 1-844-740-7500 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch
Use
Indications
INDICATIONS AND USAGE Ciprofloxacin Ophthalmic Solution is indicated for the treatment of infections caused by susceptible strains of the designated microorganisms in the conditions listed below: Corneal Ulcers: Pseudomonas aeruginosa Serratia marcescens * Staphylococcus aureus Staphylococcus epidermidis Streptococcus pneumoniae Streptococcus (Viridans Group) * Conjunctivitis: Haemophilus influenzae Staphylococcus aureus Staphylococcus epidermidis Streptococcus pneumoniae *Efficacy for this organism was studied in fewer than 10 infections.
Pharmacology
Mode of action
Combination product.
Full mechanism text
Combination product. Component mechanism (Ciprofloxacin): Interferes with bacterial DNA synthesis by inhibiting topoisomerase II (DNA gyrase) and topoisomerase IV
ADME
Pharmacokinetics & PD
| Onset | 1–2 hours oral |
|---|---|
| Duration | 12–24 hours (agent-dependent) |
| Route | OPHTHALMIC |
| Absorption | A systemic absorption study was performed in which Ciprofloxacin Ophthalmic Solution was administered in each eye every two hours while awake for two days followed by every four hours while awake for an additional 5 days. The maximum reported plasma concentration of ciprofloxacin... |
Full PK/PD text
CLINICAL PHARMACOLOGY Systemic Absorption: A systemic absorption study was performed in which Ciprofloxacin Ophthalmic Solution was administered in each eye every two hours while awake for two days followed by every four hours while awake for an additional 5 days. The maximum reported plasma concentration of ciprofloxacin was less than 5 ng/mL. The mean concentration was usually less than 2.5 ng/mL. Microbiology : Ciprofloxacin has in vitro activity against a wide range of gram-negative and gram-positive organisms. The bactericidal action of ciprofloxacin results from interference with the enzyme DNA gyrase which is needed for the synthesis of bacterial DNA. Ciprofloxacin has been shown to be active against most strains of the following organisms both in vitro and in clinical infections ( see Indications and Usage ): Gram-Positive: Staphylococcus aureus Staphylococcus epidermidis Streptococcus pneumoniae Streptococcus (Viridans Group) Gram-Negative: Haemophilus influenzae Pseudomonas aeruginosa Serratia marcescens Ciprofloxacin has been shown to be active in vitro against most strains of the following organisms, however, the clinical significance of these data is unknown: Gram-Positive: Enterococcus faecalis (Many strains are only moderately susceptible) Staphylococcus haemolyticus Staphylococcus hominis Staphylococcus saprophyticus Streptococcus pyogenes Gram-Negative Acinetobacter calcoaceticus subsp. anitratus Aeromonas caviae Aeromonas hydrophila Brucella melitensis Campylobacter coli Campylobacter jejuni Citrobacter diversus Citrobacter freundii Edwardsiella tarda Enterobacter aerogenes Enterobacter cloacae Escherichia coli Haemophilus ducreyi Haemophilus parainfluenzae Kiebsiella pneumoniae Klebsiella oxytoca Legionella pneumophila Moraxella (Branhamella) catarrhalis Morganella morganii Neisseria gonorrhoeae Neisseria meningitides Pasteurella multocida Proteus mirabilis Proteus vulgaris Providencia rettgeri Providencia stuartii Salmonella enteritidis Salmonella typhi Shigella sonneii Shigella flexneri Vibrio cholera Vibrio parahaemolyticus Vibrio vulnificus Yersinia enterocolitica Other Organisms: Chlamydia trachomatis (only moderately susceptible) and Mycobacterium tuberculosis (only moderately susceptible). Most strains of Pseudomonas cepacia and some strains of Pseudomonas maltophilia are resistant to ciprofloxacin as are most anaerobic bacteria, including Bacteroides fragilis and Clostridium difficile. The minimal bactericidal concentration (MBC) generally does not exceed the minimal inhibitory concentration (MIC) by more than a factor of 2. Resistance to ciprofloxacin in vitro usually develops slowly (multiple-step mutation). Ciprofloxacin does not cross-react with other antimicrobial agents such as beta-lactams or aminoglycosides; therefore, organisms resistant to these drugs may be susceptible to ciprofloxacin.
Kenya
Brands & prices
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|---|---|---|---|
| No brands linked yet. | |||
Special populations
Pregnancy & lactation
Pregnancy
[Ciprofloxacin] Generally avoid unless no safer alternative; animal arthropathy concerns and limited human data for many agents. [Tinidazole] 8.1 Pregnancy Risk Summary Available published data from a case-control study and case report with Tinidazole Tablets use in pregnant women are insufficient to identify a risk of major birth defects, miscarriage or adverse maternal or fetal outcomes. There are risks associated with untreated lower genital tract infections during pregnancy (see Clinical Considerations) . In animal reproduction studies, oral administration of tinidazole to pregnant mice and rats during organogenesis at 6 and 3 times, respectively, the maximum recommended human dose (based on body surface area comparison) showed a slight increase in fetal mortality in rats at the highest dose, with no other adverse fetal effects noted in either species (see Data) . The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively. Data Animal Data Embryo-fetal developmental toxicity studies in pregnant mice administered oral tinidazole on gestation days (GD) 7 to 12 indicated no embryo-fetal toxicity or malformations at the highest dose level of 2,500 mg/kg (approximately 6.3-fold the highest human therapeutic dose based upon body surface area conversions). In a study with pregnant rats administered oral tinidazole on GD 9 to 14, a slightly higher incidence of fetal mortality was observed at a maternal dose of 500 mg/kg (2.5-fold the highest human therapeutic dose based upon body surface area conversions). No biologically relevant neonatal developmental effects were observed in surviving rat neonates following maternal doses as high as 600 mg/kg (3-fold the highest human therapeutic dose based upon body surface area conversions).
Lactation
Nursing Mothers: It is not known whether topically applied ciprofloxacin is excreted in human milk. However, it is known that orally administered ciprofloxacin is excreted in the milk of lactating rats and oral ciprofloxacin has been reported in human breast milk after a single 500 mg dose. Caution should be exercised when Ciprofloxacin Ophthalmic Solution is administered to a nursing mother.
Diet
Food & alcohol
- Drug & food interactions (label) Drug Interactions: Specific drug interaction studies have not been conducted with ophthalmic ciprofloxacin. However, the systemic administration of some quinolones has been shown to elevate plasma concentrations of theophylline, interfere with the metabolism of caffeine, enhance the effects of the oral anticoagulant, warfarin, and its derivatives, and has been associated with transient elevations in serum creatinine in patients receiving cyclosporine concomitantly.
Trust
Sources & disclaimer
Source: Local active-ingredient clinical extract; FDA drug label via OpenFDA/DailyMed; Component monographs (multi-source pipeline); Professional class pharmacology (Fluoroquinolone antibiotic)
Clinical review date not recorded.
Decision support only — not a substitute for clinical judgment, product SmPC, or Kenya STG/EML.