Moxifloxacin Ophthalmic Solution USP 0.5% w/v Taj Pharma


Moxifloxacin Ophthalmic Solution USP 0.5% w/v Taj Pharma


Each ml of solution contains:
Moxifloxacin hydrochloride 5.45mg equivalent to

For the full list of excipients, see section 6.1.


Eye drops (solution).

Clear, greenish-yellow solution.


4.1 Therapeutic indications

Topical treatment of purulent bacterial conjunctivitis, caused by moxifloxacin susceptible strains (see sections 4.4 and 5.1). Consideration should be given to official guidance on the appropriate use of antibacterial agents.

4.2 Posology and method of administration

Use in adults including the elderly (≥ 65 years)

The dose is one drop in the affected eye(s) 3 times a day.

The infection normally improves within 5 days and treatment should then be continued for a further 2-3 days. If no improvement is observed within 5 days of initiating therapy, the diagnosis and/or treatment should be reconsidered. The duration of treatment depends on the severity of the disorder and on the clinical and bacteriological course of infection.

Paediatric patients

No dosage adjustment is necessary.

Use in hepatic and renal impairment

No dosage adjustment is necessary.

Method of administration

For ocular use only. Not for injection. Moxivig 0.5%w/v eye drops, solution should not be injected subconjunctivally or introduced directly into the anterior chamber of the eye.

To prevent contamination of the dropper tip and solution, care must be taken not to touch the eyelids, surrounding areas or other surfaces with the dropper tip of the bottle.

In order to prevent the drops from being absorbed via the nasal mucosa, particularly in new-born infants or children, the nasolacrimal ducts should be held closed for 2 to 3 minutes with the fingers after administering the drops. After cap is removed, if tamper evident snap collar is loose, remove before using the product.

If more than one topical ophthalmic medicinal product is being used, the medicinal products must be administered at least 5 minutes apart. Eye ointments should be administered last.

4.3 Contraindications

Hypersensitivity to the active substance, to other quinolones, or to any of the excipients listed in section 6.1.

4.4 Special warnings and precautions for use

In patients receiving systemically administered quinolones, serious and occasionally fatal hypersensitivity (anaphylactic) reactions have been reported, some following the first dose. Some reactions were accompanied by cardiovascular collapse, loss of consciousness, angioedema (including laryngeal, pharyngeal or facial oedema), airway obstruction, dyspnoea, urticaria, and itching (see section 4.8).

If an allergic reaction to Moxifloxacin Ophthalmic Solution USP 0.5% w/v Taj Pharma occurs, discontinue use of the medicinal product. Serious acute hypersensitivity reactions to moxifloxacin or any other product ingredient may require immediate emergency treatment. Oxygen and airway management should be administered where clinically indicated.

As with other anti-infectives, prolonged use may result in overgrowth of non-susceptible organisms, including fungi. If superinfection occurs, discontinue use and institute alternative therapy.

Tendon inflammation and rupture may occur with systemic fluoroquinolone therapy including moxifloxacin, particularly in older patients and those treated concurrently with corticosteroids. Following ophthalmic administration of Moxifloxacin Ophthalmic Solution USP 0.5% w/v Taj Pharma plasma concentrations of moxifloxacin are much lower than after therapeutic oral doses of moxifloxacin (see section 4.5 and 5.2), however, caution should be exercised and treatment with Moxifloxacin Ophthalmic Solution USP 0.5% w/v Taj Pharma should be discontinued at the first sign of tendon inflammation (see section 4.8).

Moxifloxacin Ophthalmic Solution USP 0.5% w/v Taj Pharma should not be used for the prophylaxis or empiric treatment of gonococcal conjunctivitis, including gonococcal ophthalmia neonatorum, because of the prevalence of fluoroquinolone-resistant Neisseria gonorrhoeae. Patients with eye infections caused by Neisseria gonorrhoeae should receive appropriate systemic treatment.

Patients should be advised not to wear contact lenses if they have signs and symptoms of a bacterial ocular infection.

Paediatric population

Data are very limited to establish efficacy and safety of VIGAMOX in the treatment of conjunctivitis in neonates. Therefore use of this medicinal product to treat conjunctivitis in neonates is not recommended.

Neonates with ophthalmia neonatorum should receive appropriate treatment for their condition, e.g. systemic treatment in cases caused by Chlamydia trachomitis or Neisseria gonorrhoeae.

The medicinal product is not recommended for the treatment of Chlamydia trachomatis in patients less than 2 years of age as it has not been evaluated in such patients. Patients older than 2 years of age with eye infections caused by Chlamydia trachomitis should receive appropriate systemic treatment.

4.5 Interaction with other medicinal products and other forms of interaction

No specific interaction studies have been performed with Moxifloxacin Ophthalmic Solution USP 0.5% w/v Taj Pharma 0.5%w/v eye drops, solution. Given the low systemic concentration of moxifloxacin following topical ocular administration of the medicinal product (see Section 5.2), drug interactions are unlikely to occur.

4.6 Fertility, pregnancy and lactation


There are no or limited amount of data from the use of Moxifloxacin Ophthalmic Solution USP 0.5% w/v Taj Pharma in pregnant women. However, no effects on pregnancy are anticipated since the systemic exposure to moxifloxacin is negligible. The medicinal product can be used during pregnancy.


It is unknown whether moxifloxacin/metabolites are excreted in human milk. Animal studies have shown excretion of low levels in breast milk after oral administration of moxifloxacin. However, at therapeutic doses of Moxifloxacin Ophthalmic Solution USP 0.5% w/v Taj Pharma no effects on the suckling child are anticipated. The medicinal product can be used during breast-feeding.


Studies have not been performed to evaluate the effect of ocular administration of Moxifloxacin Ophthalmic Solution USP 0.5% w/v Taj Pharma on fertility.

4.7 Effects on ability to drive and use machines

Moxifloxacin Ophthalmic Solution USP 0.5% w/v Taj Pharma has no or negligible influence on the ability to drive and use machines, however, as with any eye drops, temporary blurred vision or other visual disturbances may affect the ability to drive or use machines. If blurred vision occurs at instillation, the patient should wait until their vision clears before driving or using machinery.

4.8 Undesirable effects

Summary of the safety profile

In clinical studies involving 2,252 patients, Moxifloxacin Ophthalmic Solution USP 0.5% w/v Taj Pharma was administered up to 8 times a day, with over 1,900 of these patients receiving treatment 3 times daily. The overall safety population that received the medicinal product consisted of 1,389 patients from the United States and Canada, 586 patients from Japan and 277 patients from India. No serious ophthalmic or systemic undesirable effects related to the medicinal product were reported in any of the clinical studies. The most frequently reported treatment-related undesirable effects with the medicinal product were eye irritation and eye pain, occurring at an overall incidence of 1 to 2%. These reactions were mild in 96% of those patients who experienced them, with only 1 patient discontinuing therapy as a result.

Tabulated summary of adverse reactions

The following adverse reactions are classified according to the following convention: very common (≥1/10), common (≥1/100 to <1/10), uncommon (≥1/1,000 to <1/100), rare (≥1/10,000 to <1/1,000), very rare (<1/10,000) or not known (cannot be estimated from the available data). Within each frequency grouping, undesirable effects are presented in decreasing order of seriousness.

System Organ Classification Frequency Adverse reactions
Blood and lymphatic system disorders Rare haemoglobin decreased
Immune system disorders Not known Hypersensitivity
Nervous system disorders Uncommon


Not known




Eye disorders Common





Not known

eye pain, eye irritation

punctate keratitis, dry eye, conjunctival haemorrhage, ocular hyperaemia, eye pruritus, eyelid oedema, ocular discomfort,

corneal epithelium defect, corneal disorder, conjunctivitis, blepharitis, eye swelling, conjunctival oedema, vision blurred, visual acuity reduced, asthenopia, erythema of eyelid

endophthalmitis, ulcerative keratitis, corneal erosion, corneal abrasion, intraocular pressure increased, corneal opacity, corneal infiltrates, corneal deposits, eye allergy, keratitis, corneal oedema, photophobia, eyelid oedema, lacrimation increased, eye discharge, foreign body sensation in eyes

Cardiac disorders Not known palpitations
Respiratory, thoracic and mediastinal disorders Rare
Not known
nasal discomfort, pharyngolaryngeal pain, sensation of foreign body (throat)


Gastrointestional disorders Uncommon


Not known




Hepatobiliary disorders Rare alanine aminotransferase increased, gamma-glutamyltransferase increased
Skin and subcutaneous tissue disorders Not known erythema, rash, pruritus, urticaria

Description of selected adverse reactions

Serious and occasionally fatal hypersensitivity (anaphylactic) reactions, some following first dose, have been reported in patients receiving systemic quinolone therapy. Some reactions were accompanied by cardiovascular collapse, loss of consciousness, angioedema (including laryngeal, pharyngeal or facial oedema), airway obstruction, dyspnoea, urticaria and itching (see section 4.4).

Ruptures of the shoulder, hand, Achilles, or other tendons that required surgical repair or resulted in prolonged disability have been reported in patients receiving systemic fluoroquinolones. Studies and post marketing experience with systemic quinolones indicate that a risk of these ruptures may be increased in patients receiving corticosteroids, especially geriatric patients and in tendons under high stress, including Achilles tendon (see section 4.4).

Paediatric population

In clinical trials, Moxifloxacin Ophthalmic Solution USP 0.5% w/v Taj Pharma has shown to be safe in paediatric patients, including neonates. In patients under 18 years old, the two most frequent adverse reactions were eye irritation and eye pain, both occurring at an incidence rate of 0.9%.

Based on data from clinical trials involving paediatric patients, including neonates (see section 5.1), the type and severity of adverse reactions in the paediatric population are similar to those in adults.

Reporting of suspected adverse reactions

Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of benefit/risk balance of the medicinal product. Health care professionals are asked to report any suspected adverse reactions


5.1 Pharmacodynamic properties

Pharmacotherapeutic group: Ophthalmologicals; anti-infectives, other anti-infectives

Mechanism of Action:

Moxifloxacin, a fourth-generation fluoroquinolone, inhibits the DNA gyrase and topoisomerase IV required for bacterial DNA replication, repair, and recombination.


Resistance to fluoroquinolones, including moxifloxacin generally occurs by chromosomal mutations in genes encoding DNA gyrase and topoisomerase IV. In Gram-negative bacteria, moxifloxacin resistance can be due to mutations in mar (multiple antibiotic resistance) and the qnr (quinolone resistance) gene systems. Resistance is also associated with expression of bacteria efflux proteins and inactivating enzymes. Cross-resistance with beta-lactams, macrolides and aminoglycosides is not expected due to differences in mode of action.

Susceptibility Testing Breakpoints

There are no pharmacological data correlated with clinical outcome for moxifloxacin administered as a topical agent. As a result, the European Committee on Antimicrobial Susceptibility Testing (EUCAST) suggests the following epidemiological cut-off values (ECOFF mg/l) derived from MIC distribution curves to indicate susceptibility to topical moxifloxacin:

Corynebacterium ND
Staphylococcus aureus 0.25 mg/l
Staphylococcus, coag-neg. 0.25 mg/l
Streptococcus pneumoniae 0.5 mg/l
Streptococcus pyogenes 0.5 mg/l
Streptococcus, viridans group 0.5 mg/l
Enterobacter spp. 0.25 mg/l
Haemophilus influenzae 0.125 mg/l
Klebsiella spp. 0.25 mg/l
Moraxella catarrhalis 0.25 mg/l
Morganella morganii 0.25 mg/l
Neisseria gonorrhoeae 0.032 mg/l
Pseudomonas aeruginosa 4 mg/l
Serratia marcescens 1 mg/l

The prevalence of acquired resistance may vary geographically and with time for selected species and local information on resistance is desirable, particularly when treating severe infections. As necessary, expert advice should be sought when the local prevalence of resistance is such that the utility of moxifloxacin in at least some types of infections is questionable.

Aerobic Gram-positive micro-organisms:

Corynebacterium species including

Corynebacterium diphtheriae

Staphylococcus aureus (methicillin susceptible)

Streptococcus pneumoniae

Streptococcus pyogenes

Streptococcus viridans Group

Aerobic Gram-negative micro-organisms:

Enterobacter cloacae

Haemophilus influenzae

Klebsiella oxytoca

Moraxella catarrhalis

Serratia marcescens

Anaerobic micro-organisms:

Proprionibacterium acnes

Other micro-organisms:

Chlamydia trachomatis

Aerobic Gram-positive micro-organisms:

Staphylococcus aureus (methicillin resistant)

Staphylococcus, coagulase-negative species (methicillin resistant)

Aerobic Gram-negative micro-organisms:

Neisseria gonorrhoeae

Other micro-organisms:



Aerobic Gram-negative micro-organisms:

Pseudomonas aeruginosa

Other micro-organisms:


5.2 Pharmacokinetic properties

Following topical ocular administration of Moxifloxacin Ophthalmic Solution USP 0.5% w/v Taj Pharma, moxifloxacin was absorbed into the systemic circulation. Plasma concentrations of moxifloxacin were measured in 21 male and female subjects who received bilateral topical ocular doses of the medicinal product 3 times a day for 4 days. The mean steady-state Cmax and AUC were 2.7 ng/ml and 41.9 ng·hr/ml, respectively. These exposure values are approximately 1,600 and 1,200 times lower than the mean Cmax and AUC reported after therapeutic 400 mg oral doses of moxifloxacin. The plasma half-life of moxifloxacin was estimated to be 13 hours.

5.3 Preclinical safety data

Effects in non-clinical studies were observed only at exposures considered sufficiently in excess of the maximum human exposure following administration to the eye indicating little relevance to clinical use.

As with other quinolones, moxifloxacin was also genotoxic in vitro in bacteria and mammalian cells. As these effects can be traced to the interaction with bacterial gyrase and in considerably higher concentrations to the interaction with topoisomerase II in mammalian cells, a threshold level for genotoxicity can be assumed. In in vivo tests, no evidence of genotoxicity was found, despite high doses of moxifloxacin. The therapeutic doses for human use therefore provide adequate safety margin. No indication of a carcinogenic effect was observed in an initiation promotion model in rats.

Unlike other quinolones, moxifloxacin showed no phototoxic or photogenotoxic properties in extensive in vitro and in vivo studies.


6.1 List of excipients

Sodium chloride, Boric acid, Hydrochloric acid and/or sodium hydroxide (to adjust pH), Purified water

6.2 Incompatibilities

Not applicable.

6.3 Shelf life

3 years

Discard 4 weeks after first opening.

6.4 Special precautions for storage

This medicinal product does not require any special storage conditions.

6.5 Nature and contents of container

5 ml bottle with DROP-TAINER dispensing system consisting of a transparent low density polyethylene bottle and dispensing plug and white polypropylene closure. Tamper evidence is provided by a security seal around the closure of the bottle.

Pack size: box containing 1 bottle.

6.6 Special precautions for disposal and other handling

Any unused product or waste material should be disposed of in accordance with local requirements.


Mumbai, India
Unit No. 214.Old Bake House,
Maharashtra chambers of  Commerce Lane,
Fort, Mumbai – 400001
at:Gujarat, INDIA.
Customer Service and Product Inquiries:
1-800-TRY-FIRST (1-800-222-434 & 1-800-222-825)
Monday through Saturday 9:00 a.m. to 7:00 p.m. EST

0.5% W/V


Moxifloxacin hydrochloride

Read all of this leaflet carefully before you start using this medicine because it contains important information for you.

  • Keep this leaflet. You may need to read it again.
  • If you have any further questions, ask your doctor or pharmacist.
  • This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
  • If you get any of the side effects talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.


  1. What Moxifloxacin Hydrochloride is and what it is used for
  2. What you need to know before you use Moxifloxacin Hydrochloride
  3. How to use Moxifloxacin Hydrochloride
  4. Possible side effects
  5. How to store Moxifloxacin Hydrochloride
  6. Contents of the pack and other information1. WHAT MOXIFLOXACIN HYDROCHLORIDE* IS AND WHAT IT IS USED FOR

Moxifloxacin Hydrochloride eye drops are used for the treatment of infections of the eye (conjunctivitis) when caused by bacteria. The active ingredient is moxifloxacin an ophthalmological anti-infective.


Do not use Moxifloxacin Hydrochloride

  • If you are allergic (hypersensitive) to moxifloxacin, to other quinolones, or any of the other ingredients of this medicine (listed in section 6).

Warnings and Precautions

  • Talk to your doctor or pharmacist:
  • If you experience an allergic reaction to Moxifloxacin Hydrochloride. Allergic reactions occur uncommonly and serious reactions occur rarely. If you experience any allergic (hypersensitivity) reaction or any side effect please refer to section 4.
  • If you wear contact lenses – stop wearing your lenses if you have any signs or symptoms of an eye infection. Wear your glasses instead. Do not start wearing your lenses again until the signs and symptoms of the infection have cleared and until you have stopped using the medicine.
  • Tendon swelling and rupture have happened in people taking oral or intravenous fluoroquinolones, particularly in older patients and in those treated concurrently with corticosteroids. Stop taking Moxifloxacin Hydrochloride if you develop pain or swelling of the tendons (tendinitis).

As with any antibiotic, use of Moxifloxacin Hydrochloride for a long time may lead to other infections.

Other medicines and Moxifloxacin Hydrochloride

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including medicines obtained without a prescription.

Pregnancy, breast feeding and fertility

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist before using VIGAMOX eye drops.

Driving and using machines

You may find that your vision is blurred for a short time just after you use Moxifloxacin Hydrochloride. Do not drive or use machines until this has worn off.


Always use this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.

The recommended dose is…

Adults, including the older, and children:

1 drop in the affected eye or eyes, 3 times a day (in the morning, in the afternoon and at night).

Moxifloxacin Hydrochloride can be used in children, in patients over 65 years of age and patients with kidney or liver problems. There is only very limited information on the use of this medicine in the newborn and its use is not recommended in the newborn.

Only use the medicine in both eyes if your doctor told you to. Only use Moxifloxacin Hydrochloride for dropping in your eyes.

The infection normally improves within 5 days. If no improvement is seen, contact your doctor. You should continue to use the drops for a further 2 – 3 days or as long as your doctor told you to.

  • Get the Moxifloxacin Hydrochloride bottle and stand in front of a mirror
  • Wash your hands
  • Twist off the cap
  • After cap is removed, if tamper evident snap collar is loose, remove before using the product
  • Hold the bottle, pointing down, between your thumb and fingers
  • Tilt your head back. Pull down your eyelid with a clean finger, until there is a ‘pocket’ between the eyelid and your eye. The drop will go in here.
  • Bring the bottle tip close to the eye. Use the mirror if it helps
  • Do not touch your eye or eyelid, surrounding areas or other surfaces with the dropper. It could infect the drops
  • Gently press the bottom of the bottle to release one drop of medicine at a time

After using Moxifloxacin Hydrochloride, press a finger into the corner of your eye, by the nose for 2 – 3 minutes. This helps to stop the medicine getting into the rest of the body and is important in young children

  • If you are using the drops in both eyes, wash your hands before you repeat the steps for your other eye. This will help prevent spreading the infection from one eye to the other
  • Close the bottle cap firmly immediately after use

How to use moxifloxacin hydrochloride (continued)

If a drop misses your eye, try again.

If you use more medicine than you should, rinse it all out with warm water. Do not put in any more drops until it is time for your next regular dose.

If you accidentally swallow Moxifloxacin Hydrochloride contact your doctor or pharmacist for advice.

If you forget to use the medicine, continue with the next dose as planned. Do not use a double dose to make up for a forgotten dose.

If you are using other eye drops, leave at least 5 minutes between putting in Moxifloxacin Hydrochloride and the other drops.

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.


Like all medicines Moxifloxacin Hydrochloride can cause side effects although not everybody gets them.

You can usually carry on taking the drops, unless the effects are serious or if you suffer a severe allergic reaction.

If you experience a severe allergic reaction and any of the following happen, stop taking Moxifloxacin Hydrochloride immediately and tell your doctor immediately: swelling of the hands, feet, ankles, face, lips, mouth or throat which may cause difficulty in swallowing or breathing, rash or hives, large fluid – filled blisters, sores and ulceration.

Common side effects

(May affect up to 1 in 10 people)

Effects in the eye: eye pain, eye irritation

Uncommon side effects

(May affect up to 1 in 100 people)

Effects in the eye: dry eye, itchy eye, redness of the eye, eye surface inflammation or scarring, broken blood vessel in eye, abnormal eye sensation, eyelid abnormality, itching, redness or swelling

General side effects: headache and bad taste

Rare side effects

(May affect up to 1 in 1000 people)

Effects in the eye: corneal disorder, blurred or reduced vision, inflammation or infection of the conjunctiva, eye strain, eye swelling

General side effects: vomiting, nose discomfort, feeling of a lump in the throat, decreased iron in blood, abnormal liver blood tests, abnormal skin sensation, pain, throat irritation

Not known

(Frequency cannot be estimated from the available data)

Effects in the eye: infection in the eye, eye surface becomes cloudy, corneal swelling, deposits on the eye surface, increased pressure in eye, scratch on surface of eye, eye allergy, eye discharge, increased tear production, sensitivity to light

General side effects: shortness of breath, irregular heart rhythm, dizziness, increased allergic symptoms, itching, rash, skin redness, nausea and urticaria

Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet.


Keep this medicine out of the sight and reach of children.

Do not use this medicication after the expiry date which is stated on the bottle and the carton after ‘Exp’. The expiry date refers to the last day of that month.

This medicine does not need any special storage conditions.

Stop using the bottle 4 weeks after first opening. This is to prevent infections.

Do not throw away medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.


The active substance is moxifloxacin. One ml of eye drops contains 5 mg of moxifloxacin (as moxifloxacin hydrochloride, 5.45 mg).

One eye drop contains 190 micrograms of moxifloxacin.

The other ingredients are: sodium chloride, boric acid, purified water.

Tiny amounts of sodium hydroxide and hydrochloric acid may be added to keep acidity levels (pH levels) normal.

What Moxifloxacin Hydrochloride looks like and the contents of the pack

The medicine is a liquid (a clear, greenish–yellow solution) supplied in a pack containing one 5 ml plastic bottle with a screw cap.


Mumbai, India
Unit No. 214.Old Bake House,
Maharashtra chambers of  Commerce Lane,
Fort, Mumbai – 400001
at:Gujarat, INDIA.
Customer Service and Product Inquiries:
1-800-TRY-FIRST (1-800-222-434 & 1-800-222-825)
Monday through Saturday 9:00 a.m. to 7:00 p.m. EST

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