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NDC 63187-0163-05 GENTAMICIN SULFATE 3 mg/mL Details
GENTAMICIN SULFATE 3 mg/mL
GENTAMICIN SULFATE is a OPHTHALMIC SOLUTION/ DROPS in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Proficient Rx LP. The primary component is GENTAMICIN SULFATE.
MedlinePlus Drug Summary
Ophthalmic gentamicin is used to treat certain eye infections. Gentamicin is in a class of medications called antibiotics. It works by killing the bacteria that cause infection.
Related Packages: 63187-0163-05Last Updated: 12/01/2022
MedLinePlus Full Drug Details: Gentamicin Ophthalmic
Product Information
| NDC | 63187-0163 |
|---|---|
| Product ID | 63187-163_9bc97257-3fe5-45aa-a544-78d044982cd4 |
| Associated GPIs | 86101030002005 |
| GCN Sequence Number | 007984 |
| GCN Sequence Number Description | gentamicin sulfate DROPS 0.3 % OPHTHALMIC |
| HIC3 | Q6W |
| HIC3 Description | OPHTHALMIC ANTIBIOTICS |
| GCN | 33600 |
| HICL Sequence Number | 004032 |
| HICL Sequence Number Description | GENTAMICIN SULFATE |
| Brand/Generic | Generic |
| Proprietary Name | GENTAMICIN SULFATE |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | gentamicin sulfate |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Dosage Form | SOLUTION/ DROPS |
| Route | OPHTHALMIC |
| Active Ingredient Strength | 3 |
| Active Ingredient Units | mg/mL |
| Substance Name | GENTAMICIN SULFATE |
| Labeler Name | Proficient Rx LP |
| Pharmaceutical Class | Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS] |
| DEA Schedule | n/a |
| Marketing Category | ANDA |
| Application Number | ANDA062452 |
| Listing Certified Through | 2024-12-31 |
Package
Package Images
NDC 63187-0163-05 (63187016305)
| NDC Package Code | 63187-163-05 |
|---|---|
| Billing NDC | 63187016305 |
| Package | 1 BOTTLE, DROPPER in 1 CARTON (63187-163-05) / 5 mL in 1 BOTTLE, DROPPER |
| Marketing Start Date | 2019-01-01 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |
Standard Product Labeling (SPL)/Prescribing Information SPL 3ab508ed-4b12-4dd7-a13e-1a071f560286 Details
DESCRIPTION
Gentamicin sulfate ophthalmic solution, USP is a sterile, topical anti-infective agent for ophthalmic use.
Gentamicin is obtained from cultures of Micromonospora purpurea. It is a mixture of the sulfate salts of gentamicin C1, C2, and C1A. All three components appear to have similar antimicrobial activity. Gentamicin sulfate occurs as a white to buff powder and is soluble in water and insoluble in alcohol. The structural formula is as follows:
Each mL contains: Active: gentamicin sulfate equivalent to 3 mg (0.3%) gentamicin base. Preservative: benzalkonium chloride. Inactives: edetate disodium; polyvinyl alcohol 1.4%; purified water; sodium chloride; sodium phosphate, dibasic; and hydrochloric acid and/or sodium hydroxide may be added to adjust pH. The solution is an aqueous, buffered solution with a shelf life pH range of 6.5 to 7.5.
CLINICAL PHARMACOLOGY
Microbiology
Gentamicin sulfate is active in vitro against many strains of the following microorganisms: Staphylococcus aureus, Staphylococcus epidermidis, Streptococcus pyogenes, Streptococcus pneumoniae, Enterobacter aerogenes, Escherichia coli, Haemophilus influenzae, Klebsiella pneumoniae, Neisseria gonorrhoeae, Pseudomonas aeruginosa, and Serratia marcescens.
INDICATIONS AND USAGE
Gentamicin sulfate ophthalmic solution, USP is indicated in the topical treatment of ocular bacterial infections including conjunctivitis, keratitis, keratoconjunctivitis, corneal ulcers, blepharitis, blepharoconjunctivitis, acute meibomianitis, and dacryocystitis, caused by susceptible strains of the following microorganisms: Staphylococcus aureus, Staphylococcus epidermidis, Streptococcus pyogenes, Streptococcus pneumoniae, Enterobacter aerogenes, Escherichia coli, Haemophilus influenzae, Klebsiella pneumoniae, Neisseria gonorrhoeae, Pseudomonas aeruginosa, and Serratia marcescens.
CONTRAINDICATIONS
WARNINGS
PRECAUTIONS
General
Prolonged use of topical antibiotics may give rise to overgrowth of nonsusceptible microorganisms, including fungi. Bacterial resistance to gentamicin may also develop. If purulent discharge, inflammation or pain becomes aggravated, the patient should discontinue use of the medication and consult a physician.
If irritation or hypersensitivity to any component of the drug develops, the patient should discontinue use of this preparation and appropriate therapy should be instituted.
Information for Patients
To avoid contamination, do not touch tip of container to the eye, eyelid or any surface.
Carcinogenesis, Mutagenesis, Impairment of Fertility
There are no published carcinogenicity or impairment of fertility studies on gentamicin. Aminoglycoside antibiotics have been found to be non-mutagenic.
Pregnancy
Pregnancy Category C
Gentamicin has been shown to depress body weights, kidney weights and median glomerular counts in newborn rats when administered systemically to pregnant rats in daily doses approximately 500 times the maximum recommended ophthalmic human dose. There are no adequate and well-controlled studies in pregnant women. Gentamicin should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.
ADVERSE REACTIONS
Bacterial and fungal corneal ulcers have developed during treatment with gentamicin ophthalmic preparations.
The most frequently reported adverse reactions are ocular burning and irritation upon drug instillation, non-specific conjunctivitis, conjunctival epithelial defects and conjunctival hyperemia.
Other adverse reactions which have occurred rarely are allergic reactions, thrombocytopenic purpura and hallucinations.
DOSAGE AND ADMINISTRATION
HOW SUPPLIED
Gentamicin sulfate ophthalmic solution, USP 0.3% is supplied sterile in white opaque LDPE plastic bottles and tips with white high impact polystyrene (HIPS) caps as follows:
- 5 mL in 10 mL bottle – NDC 63187-163-05
Storage: Store at or below 25°C (77°F). Avoid exposure to excessive heat (40°C/104°F or above).
Revised: 08/2013
Distributed for:
Allegan USA, Inc.
Madison, NJ 07940 Made in the U.S.A.
© 2013 Allergan, Inc.
Irvine, CA 92612, U.S.A.
® mark owned by Allergan, Inc.
71759PY11
Relabeled by:
Proficient Rx LP
Thousand Oaks, CA 91320
INGREDIENTS AND APPEARANCE
| GENTAMICIN SULFATE
gentamicin sulfate solution/ drops |
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| Labeler - Proficient Rx LP (079196022) |
| Establishment | |||
| Name | Address | ID/FEI | Business Operations |
|---|---|---|---|
| Proficient Rx LP | 079196022 | REPACK(63187-163) , RELABEL(63187-163) | |