NDC 62332-505 Moxifloxacin Ophthalmic Solution

Moxifloxacin Ophthalmic Solution

NDC Product Code 62332-505

NDC Code: 62332-505

Proprietary Name: Moxifloxacin Ophthalmic Solution What is the Proprietary Name?
The proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.

Non-Proprietary Name: Moxifloxacin Ophthalmic Solution What is the Non-Proprietary Name?
The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.

NDC Code Structure

  • 62332 - Alembic Pharmaceuticals Inc.
    • 62332-505 - Moxifloxacin Ophthalmic Solution

NDC 62332-505-03

Package Description: 1 BOTTLE in 1 CARTON > 3 mL in 1 BOTTLE

NDC Product Information

Moxifloxacin Ophthalmic Solution with NDC 62332-505 is a a human prescription drug product labeled by Alembic Pharmaceuticals Inc.. The generic name of Moxifloxacin Ophthalmic Solution is moxifloxacin ophthalmic solution. The product's dosage form is solution/ drops and is administered via ophthalmic form.

Labeler Name: Alembic Pharmaceuticals Inc.

Dosage Form: Solution/ Drops - A solution which is usually administered in a drop-wise fashion.

Product Type: Human Prescription Drug What kind of product is this?
Indicates the type of product, such as Human Prescription Drug or Human Over the Counter Drug. This data element matches the “Document Type” field of the Structured Product Listing.

Moxifloxacin Ophthalmic Solution Active Ingredient(s)

What is the Active Ingredient(s) List?
This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted.

  • MOXIFLOXACIN HYDROCHLORIDE 5 mg/mL

Inactive Ingredient(s)

About the Inactive Ingredient(s)
The inactive ingredients are all the component of a medicinal product OTHER than the active ingredient(s). The acronym "UNII" stands for “Unique Ingredient Identifier” and is used to identify each inactive ingredient present in a product.

  • SODIUM CHLORIDE (UNII: 451W47IQ8X)
  • BORIC ACID (UNII: R57ZHV85D4)
  • HYDROCHLORIC ACID (UNII: QTT17582CB)
  • SODIUM HYDROXIDE (UNII: 55X04QC32I)
  • WATER (UNII: 059QF0KO0R)

Administration Route(s)

What are the Administration Route(s)?
The translation of the route code submitted by the firm, indicating route of administration.

  • Ophthalmic - Administration to the external eye.

Pharmacological Class(es)

What is a Pharmacological Class?
These are the reported pharmacological class categories corresponding to the SubstanceNames listed above.

  • Quinolone Antimicrobial - [EPC] (Established Pharmacologic Class)
  • Quinolones - [CS]

Product Labeler Information

What is the Labeler Name?
Name of Company corresponding to the labeler code segment of the Product NDC.

Labeler Name: Alembic Pharmaceuticals Inc.
Labeler Code: 62332
FDA Application Number: ANDA209469 What is the FDA Application Number?
This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null.

Marketing Category: ANDA - A product marketed under an approved Abbreviated New Drug Application. What is the Marketing Category?
Product types are broken down into several potential Marketing Categories, such as NDA/ANDA/BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.

Start Marketing Date: 02-13-2019 What is the Start Marketing Date?
This is the date that the labeler indicates was the start of its marketing of the drug product.

Listing Expiration Date: 12-31-2020 What is the Listing Expiration Date?
This is the date when the listing record will expire if not updated or certified by the product labeler.

Exclude Flag: N What is the NDC Exclude Flag?
This field indicates whether the product has been removed/excluded from the NDC Directory for failure to respond to FDA’s requests for correction to deficient or non-compliant submissions. Values = ‘Y’ or ‘N’.

* Please review the disclaimer below.

Moxifloxacin Ophthalmic Solution Product Labeling Information

The product labeling information includes all published material associated to a drug. Product labeling documents include information like generic names, active ingredients, ingredient strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.

Product Labeling Index

1 Indications And Usage

Moxifloxacin ophthalmic solution USP is indicated for the treatment of bacterial conjunctivitis caused by susceptible strains of the following organisms:Corynebacterium species* Micrococcus luteus* Staphylococcus aureus Staphylococcus epidermidis Staphylococcus haemolyticus Staphylococcus hominis Staphylococcus warneri* Streptococcus pneumoniae Streptococcus viridans group Acinetobacter lwoffii* Haemophilus influenzae Haemophilus parainfluenzae* Chlamydia trachomatis*Efficacy for this organism was studied in fewer than 10 infections.

2 Dosage And Administration

Instill one drop in the affected eye 3 times a day for 7 days.

3 Dosage Forms And Strengths

5 mL bottle filled with 3 mL sterile ophthalmic solution of Moxifloxacin hydrochloride, 0.5% as base.

4 Contraindications

Moxifloxacin ophthalmic solution USP is contraindicated in patients with a history of hypersensitivity to Moxifloxacin, to other quinolones, or to any of the components in this medication.

5.1 Topical Ophthalmic Use Only

NOT FOR INJECTION. Moxifloxacin ophthalmic solution USP is for topical ophthalmic use only and should not be injected subconjunctivally or introduced directly into the anterior chamber of the eye.

5.2 Hypersensitivity Reactions

In patients receiving systemically administered quinolones, including moxifloxacin, 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 edema), airway obstruction, dyspnea, urticaria, and itching. If an allergic reaction to moxifloxacin occurs, discontinue use of the drug. Serious acute hypersensitivity reactions may require immediate emergency treatment. Oxygen and airway management should be administered as clinically indicated.

5.3 Growth Of Resistant Organisms With Prolonged Use

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. Whenever clinical judgment dictates, the patient should be examined with the aid of magnification, such as slit-lamp biomicroscopy, and, where appropriate, fluorescein staining.

5.4 Avoidance Of Contact Lens Wear

Patients should be advised not to wear contact lenses if they have signs or symptoms of bacterial conjunctivitis.

6 Adverse Reactions

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to the rates in the clinical trials of another drug and may not reflect the rates observed in practice. The most frequently reported ocular adverse events were conjunctivitis, decreased visual acuity, dry eye, keratitis, ocular discomfort, ocular hyperemia, ocular pain, ocular pruritus, subconjunctival hemorrhage, and tearing. These events occurred in approximately 1-6% of patients. Nonocular adverse events reported at a rate of 1-4% were fever, increased cough, infection, otitis media, pharyngitis, rash, and rhinitis.

7 Drug Interactions

Drug-drug interaction studies have not been conducted with Moxifloxacin ophthalmic solution USP.  In vitro studies indicate that moxifloxacin does not inhibit CYP3A4, CYP2D6, CYP2C9, CYP2C19, or CYP1A2, indicating that moxifloxacin is unlikely to alter the pharmacokinetics of drugs metabolized by these cytochrome P450 isozymes.

8.1 Pregnancy

Pregnancy Category C. Teratogenic Effects:  Moxifloxacin was not teratogenic when administered to pregnant rats during organogenesis at oral doses as high as 500 mg/kg/day (approximately 21,700 times the highest recommended total daily human ophthalmic dose); however, decreased fetal body weights and slightly delayed fetal skeletal development were observed. There was no evidence of teratogenicity when pregnant Cynomolgus monkeys were given oral doses as high as 100 mg/kg/day (approximately 4,300 times the highest recommended total daily human ophthalmic dose). An increased incidence of smaller fetuses was observed at 100 mg/kg/day. Since there are no adequate and well-controlled studies in pregnant women, Moxifloxacin ophthalmic solution USP should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

8.3 Nursing Mothers

Moxifloxacin has not been measured in human milk, although it can be presumed to be excreted in human milk. Caution should be exercised when Moxifloxacin ophthalmic solution USP is administered to a nursing mother.

8.4 Pediatric Use

The safety and effectiveness of Moxifloxacin ophthalmic solution USP 0.5% have been established in all ages. Use of Moxifloxacin ophthalmic solution USP is supported by evidence from adequate and well controlled studies of Moxifloxacin ophthalmic solution USP in adults, children, and neonates [see Clinical Studies (14)].There is no evidence that the ophthalmic administration of Moxifloxacin ophthalmic solution USP has any effect on weight bearing joints, even though oral administration of some quinolones has been shown to cause arthropathy in immature animals.

8.5 Geriatric Use

No overall differences in safety and effectiveness have been observed between elderly and younger patients.

11 Description

Moxifloxacin ophthalmic solution USP 0.5% is a sterile solution for topical ophthalmic use.  Moxifloxacin hydrochloride is an 8-methoxy fluoroquinolone anti-infective, with a diazabicyclononyl ring at the C7 position. Chemical Name: 1-Cyclopropyl-6-fluoro-1,4-dihydro-8-methoxy-7-[(4aS,7aS)-octahydro-6H-pyrrolol[3,4­ b]pyridin-6-yl]-4-oxo-3-quinolinecarboxylic acid, monohydrochloride. Moxifloxacin hydrochloride is a slightly yellow to yellow crystalline powder. Each mL of Moxifloxacin ophthalmic solution USP contains 5.45 mg moxifloxacin hydrochloride, equivalent to 5 mg moxifloxacin base.Contains: Active: Moxifloxacin 0.5% (5 mg/mL); Inactives: Boric acid, sodium chloride, and purified water. May also contain hydrochloric acid/sodium hydroxide to adjust pH to approximately 6.8. Moxifloxacin ophthalmic solution USP is an isotonic solution with an osmolality of approximately 290 mOsm/kg.

12.1 Mechanism Of Action

Moxifloxacin is a member of the fluoroquinolone class of anti-infective drugs (See 12.4 Microbiology).

12.3 Pharmacokinetics

Plasma concentrations of moxifloxacin were measured in healthy adult male and female subjects who received bilateral topical ocular doses of Moxifloxacin ophthalmic solution USP 3 times a day. The mean steady-state Cmax (2.7 ng/mL) and estimated daily exposure AUC (45 ng●hr/mL) values were 1,600 and 1,000 times lower than the mean Cmax and AUC reported after therapeutic 400 mg doses of moxifloxacin.  The plasma half-life of moxifloxacin was estimated to be 13 hours.

12.4 Microbiology

The antibacterial action of moxifloxacin results from inhibition of the topoisomerase II (DNA gyrase) and topoisomerase IV. DNA gyrase is an essential enzyme that is involved in the replication, transcription and repair of bacterial DNA.  Topoisomerase IV is an enzyme known to play a key role in the partitioning of the chromosomal DNA during bacterial cell division. The mechanism of action for quinolones, including moxifloxacin, is different from that of macrolides, aminoglycosides, or tetracyclines. Therefore, moxifloxacin may be active against pathogens that are resistant to these antibiotics and these antibiotics may be active against pathogens that are resistant to moxifloxacin. There is no cross-resistance between moxifloxacin and the aforementioned classes of antibiotics. Cross resistance has been observed between systemic moxifloxacin and some other quinolones.In vitro resistance to moxifloxacin develops via multiple-step mutations. Resistance to moxifloxacin occurs in vitro at a general frequency of between 1.8 x 10-9 to < 1 x 10-11 for Gram-positive bacteria. Moxifloxacin has been shown to be active against most strains of the following microorganisms, both in vitro and in clinical infections as described in the INDICATIONS AND USAGE section:Aerobic Gram-positive microorganisms:Corynebacterium species* Micrococcus luteus* Staphylococcus aureus Staphylococcus epidermidis Staphylococcus haemolyticus Staphylococcus hominis Staphylococcus warneri* Streptococcus pneumoniae Streptococcus viridans groupAerobic Gram-negative microorganisms:Acinetobacter lwoffii* Haemophilus influenzae Haemophilus parainfluenzae* Other microorganisms:Chlamydia trachomatis*Efficacy for this organism was studied in fewer than 10 infections. The following invitro data are also available, but their clinical significance in ophthalmic infections is unknown. The safety and effectiveness of Moxifloxacin ophthalmic solution USP in treating ophthalmological infections due to these microorganisms have not been established in adequate and well-controlled trials. The following organisms are considered susceptible when evaluated using systemic breakpoints. However, a correlation between the invitro systemic breakpoint and ophthalmological efficacy has not been established. The list of organisms is provided as guidance only in assessing the potential treatment of conjunctival infections. Moxifloxacin exhibits invitro minimal inhibitory concentrations (MICs) of 2 µg/ml or less (systemic susceptible breakpoint) against most (≥ 90%) strains of the following ocular pathogens.Aerobic Gram-positive microorganisms:Listeria monocytogenes Staphylococcus saprophyticus Streptococcus agalactiae Streptococcus mitis Streptococcus pyogenes Streptococcus Group C, G and FAerobic Gram-negative microorganisms:Acinetobacter baumannii Acinetobacter calcoaceticus Citrobacter freundii Citrobacter koseri Enterobacter aerogenes Enterobacter cloacae Escherichia coli Klebsiella oxytoca Klebsiella pneumoniae Moraxella catarrhalis Morganella morganii Neisseria gonorrhoeae Proteus mirabilis Proteus vulgaris Pseudomonas stutzeriAnaerobic microorganisms:Clostridium perfringens Fusobacterium species Prevotella species Propionibacterium acnesOther microorganisms:Chlamydia pneumoniae Legionella pneumophila Mycobacterium avium Mycobacterium marinum Mycoplasma pneumoniae

13.1 Carcinogenesis And Mutagenesis And Impairment Of Fertility

Long-term studies in animals to determine the carcinogenic potential of moxifloxacin have not been performed. However, in an accelerated study with initiators and promoters, moxifloxacin was not carcinogenic in rats following up to 38 weeks of oral dosing at 500 mg/kg/day (approximately 21,700 times the highest recommended total daily human ophthalmic dose for a 50 kg person, on a mg/kg basis). Moxifloxacin was not mutagenic in four bacterial strains used in the Ames Salmonella reversion assay.  As with other quinolones, the positive response observed with moxifloxacin in strain TA 102 using the same assay may be due to the inhibition of DNA gyrase. Moxifloxacin was not mutagenic in the CHO/HGPRT mammalian cell gene mutation assay. An equivocal result was obtained in the same assay when v79 cells were used. Moxifloxacin was clastogenic in the v79 chromosome aberration assay, but it did not induce unscheduled DNA synthesis in cultured rat hepatocytes.  There was no evidence of genotoxicity in vivo in a micronucleus test or a dominant lethal test in mice. Moxifloxacin had no effect on fertility in male and female rats at oral doses as high as 500 mg/kg/day, approximately 21,700 times the highest recommended total daily human ophthalmic dose. At 500 mg/kg orally there were slight effects on sperm morphology (head-tail separation) in male rats and on the estrous cycle in female rats.

14 Clinical Studies

In two randomized, double-masked, multicenter, controlled clinical trials in which patients were dosed 3 times a day for 4 days, Moxifloxacin ophthalmic solution USP produced clinical cures on day 5-6 in 66% to 69% of patients treated for bacterial conjunctivitis. Microbiological success rates for the eradication of baseline pathogens ranged from 84% to 94%.In a randomized, double-masked, multicenter, parallel-group clinical trial of pediatric patients with bacterial conjunctivitis between birth and 31 days of age, patients were dosed with Moxifloxacin ophthalmic solution USP or another anti-infective agent. Clinical outcomes for the trial demonstrated a clinical cure rate of 80% at Day 9 and a microbiological eradication success rate of 92% at Day 9. Please note that microbiologic eradication does not always correlate with clinical outcome in anti-infective trials.

16 How Supplied/Storage And Handling

Moxifloxacin ophthalmic solution USP is supplied as a sterile ophthalmic solution in dispensing system consisting of a natural low density polyethylene bottle and dispensing plug and tan polypropylene closure. Tamper evidence is provided with a shrink band around the closure and neck area of the package.3 mL in a 5 mL bottle - NDC 62332-505-03 Storage: Store at 2˚C to 25˚C (36˚F to 77˚F).

17 Patient Counseling Information

Risk of Contamination: Advise patients not to touch the dropper tip to any surface to avoid contaminating the contents.Concomitant Use of Contact Lenses: Advise patients not to wear contact lenses if they have signs and symptoms of bacterial conjunctivitis.Potential for Hypersensitivity Reactions: Systemically administered quinolones including moxifloxacin have been associated with hypersensitivity reactions, even following a single dose. Instruct patients to discontinue use immediately and contact their physician at the first sign of a rash or allergic reaction. [see Warnings and Precautions (5.2)]. Rx Only Manufactured for:Alembic Pharmaceutical, Inc. 750 Route 202, Bridgewater, NJ 08807 USA Made in India.Manufactured by:Gland Pharma Limited D.P.Pally, Dundigal Post Hyderabad -500 043, India

* Please review the disclaimer below.

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