Zymaxid
5 mg/mL · Solution/ Drops
- Prescription only
- Quinolone Antimicrobial
- Active substance
- Gatifloxacin
- Made by
- Allergan, Inc.
- Source
- Official label
Quoted from the official source. Not yet reviewed by Mediclarum — the leaflet in your pack is authoritative.
At a glance
Quoted from the official label · 2016-09-08
Quinolone Antimicrobial
- Haemophilus influenzae *Efficacy for these organisms were studied in fewer than 10 infections .
ZYMAXID ® is contraindicated in patients with a history of hypersensitivity to gatifloxacin, to other quinolones, or to any of the components in this medication [see Warnings and Precautions ( 5.1 )] .
All warnings ↓- Prescription only
- FDA enforcement reports list no ongoing recall, and none from the last two years, for this product code · checked 2026-10-02
Every line above is selected, not written, from the official label. Nothing is reworded. DailyMed
What it is for
ZYMAXID ® is indicated for the treatment of bacterial conjunctivitis caused by susceptible strains of the following organisms:
- Aerobic gram-positive bacteria:
- Staphylococcus aureus Staphylococcus epidermidis Streptococcus mitis group * Streptococcus oralis * Streptococcus pneumoniae Aerobic gram-negative bacteria:
- Haemophilus influenzae *Efficacy for these organisms were studied in fewer than 10 infections .
- ZYMAXID ® is a quinolone antimicrobial indicated for the treatment of bacterial conjunctivitis caused by susceptible strains of the following organisms:
- Haemophilus influenzae, Staphylococcus aureus, Staphylococcus epidermidis, Streptococcus mitis group , Streptococcus oralis, Streptococcus pneumoniae ( 1 )
From the official label · 2016-09-08 · DailyMed
How it works
From this product’s own US prescribing label.
Gatifloxacin is a quinolone antimicrobial [ see Microbiology ( 12.4 ) ].
Quoted from the prescribing label, sections “Mechanism of Action” and “Pharmacokinetics”. DailyMed · 2016-09-08
Do not take it if
- ZYMAXID ® is contraindicated in patients with a history of hypersensitivity to gatifloxacin, to other quinolones, or to any of the components in this medication [see Warnings and Precautions ( 5.1 )] .
- ZYMAXID ® is contraindicated in patients with a history of hypersensitivity to gatifloxacin, to other quinolones, or to any of the components in this medication.
- ( 4 )
Quoted from the official label, section “Contraindications”.
How to take it
These directions are for this exact strength and form. Another one is different.
- Day 1:
- Instill one drop every two hours in the affected eye(s) while awake, up to 8 times.
- Day 2 through Day 7:
- Instill one drop two to four times daily in the affected eye(s) while awake.
- Day 1:
- Instill one drop every two hours in the affected eye(s) while awake, up to 8 times on Day 1.
- Days 2 through 7:
- Instill one drop two to four times daily in the affected eye(s) while awake on Days 2 through 7.
- ( 2 )
Quoted from the official label, section “Dosage & Administration”.
Other warnings
- Hypersensitivity ( 5.1 ) Growth of Resistant Organisms with Prolonged Use ( 5.2 ) Corneal Endothelial Cell Injury ( 5.3 )
- 5.1 Hypersensitivity Some patients receiving topical ophthalmic gatifloxacin experienced hypersensitivity reactions including anaphylactic reactions, angioedema (including pharyngeal, laryngeal, or facial edema), dyspnea, urticaria, and itching, even following a single dose.
- Rare cases of Stevens-Johnson Syndrome were reported in association with topical ophthalmic gatifloxacin use.
- If an allergic reaction to gatifloxacin occurs, discontinue the drug [see Patient Counseling Information ( 17 )] .
- 5.2 Growth of Resistant Organisms with Prolonged Use Prolonged use of ZYMAXID ® may result in overgrowth of nonsusceptible organisms, including fungi.
- If superinfection occurs, discontinue use and institute alternative therapy.
- Whenever clinical judgment dictates, examine the patient with the aid of magnification, such as slit lamp biomicroscopy and where appropriate, fluorescein staining. 5. 3 Corneal Endothelial Cell Injury ZYMAXID ® is for topical ophthalmic use.
- ZYMAXID ® may cause corneal endothelial cell injury if introduced directly into the anterior chamber of the eye.
Quoted from the official label, section “Warnings”.
Pregnancy and breastfeeding
- Risk Summary There are no available data on the use of ZYMAXID ® in pregnant women to inform a drug-associated risk.
- Administration of oral gatifloxacin to pregnant rats and rabbits throughout organogenesis did not produce adverse development outcomes at clinically relevant doses.
- Administration of gatifloxacin to rats during late gestation through lactation did not produce adverse maternal, fetal or neonatal effects at clinically relevant doses.
- Data Animal Data Oral administration of gatifloxacin to pregnant rats throughout organogenesis produced teratogenic effects in rat fetuses, including skeletal/craniofacial malformations, delayed ossification, atrial enlargement, and reduced fetal weight, at doses greater than or equal to 150 mg/kg/day (approximately 600-fold higher than the maximum recommended human ophthalmic dose [MRHOD] for ZYMAXID ® of 0.04 mg/kg/day, on a mg/m 2 basis).
- No teratogenic effects were observed in rat or rabbit fetuses at doses of gatifloxacin up to 50 mg/kg/day (approximately 200- and 400-fold higher than the MRHOD, respectively, on a mg/m 2 basis).
- In a perinatal/postnatal study in rats, oral administration of gatifloxacin during late gestation through lactation produced an increase in late gestation fetal loss and neonatal/perinatal mortality at 200 mg/kg/day (approximately 800-fold higher than the MRHOD on a mg/m 2 basis).
- IN SPECIFIC POPULATIONS
- 8.1 Pregnancy Risk Summary There are no available data on the use of ZYMAXID ® in pregnant women to inform a drug-associated risk.
- Administration of oral gatifloxacin to pregnant rats and rabbits throughout organogenesis did not produce adverse development outcomes at clinically relevant doses.
- Administration of gatifloxacin to rats during late gestation through lactation did not produce adverse maternal, fetal or neonatal effects at clinically relevant doses.
- Data Animal Data Oral administration of gatifloxacin to pregnant rats throughout organogenesis produced teratogenic effects in rat fetuses, including skeletal/craniofacial malformations, delayed ossification, atrial enlargement, and reduced fetal weight, at doses greater than or equal to 150 mg/kg/day (approximately 600-fold higher than the maximum recommended human ophthalmic dose [MRHOD] for ZYMAXID ® of 0.04 mg/kg/day, on a mg/m 2 basis).
- No teratogenic effects were observed in rat or rabbit fetuses at doses of gatifloxacin up to 50 mg/kg/day (approximately 200- and 400-fold higher than the MRHOD, respectively, on a mg/m 2 basis).
- In a perinatal/postnatal study in rats, oral administration of gatifloxacin during late gestation through lactation produced an increase in late gestation fetal loss and neonatal/perinatal mortality at 200 mg/kg/day (approximately 800-fold higher than the MRHOD on a mg/m 2 basis).
- 8.2 Lactation Risk Summary There is no information regarding the presence of ZYMAXID ® in human milk, the effect of gatifloxacin on breastfed infants, or the effect of gatifloxacin on milk production.
- Gatifloxacin was found in the breast milk of rats following oral administration of gatifloxacin during lactation.
- However, systemic levels of gatifloxacin following topical ocular administration are low [see Clinical Pharmacology ( 12.3 ) ], and it is not known whether gatifloxacin would be present in maternal milk at measurable levels following topical ocular administration.
- The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for ZYMAXID ® and any potential adverse effects on the breastfed child from ZYMAXID ® .
- 8.4 Pediatric Use The safety and effectiveness of ZYMAXID ® in infants below one year of age have not been established.
- ZYMAXID ® has been demonstrated in clinical trials to be safe and effective for the treatment of bacterial conjunctivitis in pediatric patients one year or older [ see Clinical Studies ( 14 ) ] .
- 8.5 Geriatric Use No overall differences in safety or effectiveness have been observed between elderly and younger patients.
Quoted from the official label, section “OTC — Pregnancy or Breast Feeding”.
Use in children
- The safety and effectiveness of ZYMAXID ® in infants below one year of age have not been established.
- ZYMAXID ® has been demonstrated in clinical trials to be safe and effective for the treatment of bacterial conjunctivitis in pediatric patients one year or older [ see Clinical Studies ( 14 ) ] .
Quoted from the official label, section “Pediatric Use”.
Use in older people
No overall differences in safety or effectiveness have been observed between elderly and younger patients.
Quoted from the official label, section “Geriatric Use”.
Side effects
- The following serious adverse reactions are described elsewhere in the labeling:
- Hypersensitivity [ see Contraindications ( 4 ) and Warnings and Precautions ( 5.1 ) ] Growth of Resistant Organisms With Prolonged Use [ see Warnings and Precautions ( 5.2 ) ] Corneal Endothelial Cell Injury [ see Warnings and Precautions ( 5.3 ) ] Most common adverse reactions occurring in ≥ 1 % of patients included worsening of conjunctivitis, eye irritation, dysgeusia, and eye pain.
- ( 6 ) To report SUSPECTED ADVERSE REACTIONS, contact Allergan at 1-800-433-8871 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6. 1 Clinical Studies Experience Because clinical studies are conducted under widely varying conditions, adverse reaction rates observed in the clinical studies of a drug cannot be directly compared to rates in the clinical studies of another drug and may not reflect the rates observed in practice.
- In clinical studies of patients with bacterial conjunctivitis treated with ZYMAXID ® (N=717), the most frequently reported adverse reactions occurring in ≥ 1 % of patients were:
- worsening of the conjunctivitis, eye irritation, dysgeusia, and eye pain.
- Additional adverse reactions reported with other formulations of gatifloxacin ophthalmic solution in other clinical studies included chemosis, conjunctival hemorrhage, dry eye, eye discharge, eyelid edema, headache, increased lacrimation, keratitis, red eye, papillary conjunctivitis, and reduced visual acuity.
- 6.2 Postmarketing Experience The following adverse reactions have been identified during post-approval use of ZYMAXID ® or with other formulations of gatifloxacin ophthalmic solution.
- Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
- These reactions included anaphylactic reactions and angioedema (including pharyngeal, oral or facial edema), blepharitis, dyspnea, eye pruritus, eye swelling (including corneal and conjunctival edema), hypersensitivity, including signs and symptoms of eye allergy and allergic dermatitis, nausea, pruritus (including pruritus generalized, rash, urticaria), and vision blurred.
Quoted from the official label, section “Adverse Reactions”.
What to discuss with your doctor
- Avoiding Contamination of the Product Instruct patients to
- avoid contaminating the applicator tip with material from the eye, fingers, or other source.
- Potential for Hypersensitivity Reactions Advise patients to discontinue use immediately and contact the physician at the first sign of a rash or hypersensitivity reaction [see Warnings and Precautions ( 5.1 ) and Contraindication ( 4 ) ] . © 2017 Allergan.
- All rights reserved.
- All trademarks are the property of their respective owners.
- Patented.
- See www.allergan.com/patents Irvine, CA 92612 Made in the U.S.A. 72366US14
Quoted from the official label, section “Patient Counseling Information”.
Strengths and forms
- FORMS AND STRENGTHS Ophthalmic solution:
- 0.5% gatifloxacin (5 mg/mL) Ophthalmic solution:
- 0.5% gatifloxacin (5mg/mL) ( 3 )
Quoted from the official label, section “Dosage Forms & Strengths”.
What it looks like and how it is packed
- ZYMAXID ® (gatifloxacin ophthalmic solution) 0.5% is supplied sterile in a white, low density polyethylene (LDPE) bottle with a controlled dropper tip, and a tan, high impact polystyrene (HIPS) cap in the following size:
- 2.5 mL in 5 mL bottle:
- NDC 0023-3615-25 Storage:
- Store at 15°-25°C (59°-77°F).
- Protect from freezing.
Quoted from the official label, section “How Supplied”.
What is in it
- ZYMAXID ® is a quinolone antimicrobial topical ophthalmic solution for the treatment of bacterial conjunctivitis. Its chemical name is (±)-1-Cyclopropyl-6-fluoro-1,4-dihydro-8-methoxy-7-(3-methyl-1-piperazinyl)-4-oxo-3-quinolinecarboxylic acid, sesquihydrate. Its molecular formula is C 19 H 22 FN 3 O 4 · 1½ H 2 O and its molecular weight is 402.42. Its chemical structure is:
- ZYMAXID ® is a clear, pale yellow, sterile, preserved aqueous solution with an osmolality of 260-330 mOsm/kg and a pH of 5.1-5.7. ZYMAXID ® contains the active ingredient gatifloxacin 0.5% (5 mg/mL) and the inactive ingredients benzalkonium chloride 0.005%, edetate disodium, sodium chloride and purified water. ZYMAXID ® may contain hydrochloric acid and/or sodium hydroxide to adjust pH. The chemical structure of ZYMAXID® is a quinolone antimicrobial topical ophthalmic solution for the treatment of bacterial conjunctivitis. Its chemical name is (±)-1-Cyclopropyl-6-fluoro-1,4-dihydro-8-methoxy-7-(3-methyl-1-piperazinyl)-4-oxo-3-quinolinecarboxylic acid, sesquihydrate. Its molecular formula is C19H22FN3O4
- 1½ H2O and its molecular weight is 402.42.
Quoted from the official label, section “Description”.
Ingredients people check for
Lactose, gluten, dyes, sugars and other ingredients that matter with an allergy, intolerance or diet — as this product’s FDA label lists them.
This label’s list of inactive ingredients names none of: lactose, wheat or gluten, colour dyes, sugars, sugar alcohols, alcohol (ethanol), aspartame (phenylalanine), gelatin, peanut oil, soy, parabens, sulfites, titanium dioxide.
Quoted from the FDA label. A label that does not name an ingredient is not a guarantee that the product is free of it, and formulations change. With an allergy, check the pack and ask a pharmacist.
Every version of this medicine (3)
The same active substance, strength and kind of form, from every company that sells it — with what each label lists.
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Same active substance, strength and form in other countries
Matched on active substance, strength and kind of form only. This is not a statement that the products are equivalent or interchangeable: other ingredients, release and approved uses can differ — ask a pharmacist before swapping.
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Details
| Made by | Allergan, Inc. |
|---|---|
| Active substance | Gatifloxacin |
| Used in | Antibiotics, antivirals and antifungals taken into the body |
| Strength | 5 mg/mL |
| Form | Solution/ Drops |
| Route | Ophthalmic |
| Packs | 1 BOTTLE, DROPPER in 1 CARTON / 1 mL in 1 BOTTLE, DROPPER · 1 BOTTLE, DROPPER in 1 CARTON / 2.5 mL in 1 BOTTLE, DROPPER |
| NDC | 0023-3615 |
Source: NDC Directory · 2026-09-13 · not reviewed by a clinician
Source: US Food and Drug Administration, NDC Directory. Reuse terms: US government work (FDA).
Same active substance
These contain the same substance. That does not mean one can replace another — ask a pharmacist.