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| Product NDC Code | 0078-0925 | ||||
|---|---|---|---|---|---|
| Drug Name | Maxidex |
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| Type | Brand | ||||
| Pharm Class | Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC] |
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| Active Ingredients |
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| Route | OPHTHALMIC | ||||
| Dosage Form | SUSPENSION/ DROPS | ||||
| RxCUI drug identifier | 205669, 309692 |
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| Application Number | NDA013422 | ||||
| Labeler Name | Novartis Pharmaceuticals Corporation | ||||
| Packages |
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Adverse reactions
Information about undesirable effects, reasonably associated with use of the drug, that may occur as part of the pharmacological action of the drug or may be unpredictable in its occurrence. Adverse reactions include those that occur with the drug, and if applicable, with drugs in the same pharmacologically active and chemically related class. There is considerable variation in the listing of adverse reactions. They may be categorized by organ system, by severity of reaction, by frequency, by toxicological mechanism, or by a combination of these.ADVERSE REACTIONS Glaucoma with optic nerve damage, visual acuity and field defects; cataract formation; secondary ocular infection following suppression of host response; and perforation of the globe may occur. Clinical Studies Experience In clinical studies with MAXIDEX, the most frequently reports adverse reactions were ocular discomfort occurring in approximately 10% of the patients and eye irritation occurring in approximately 1% of the patients. All other adverse reactions from these studies occurred with a frequency less than 1%, including keratitis, conjunctivitis, dry eye, photophobia, blurred vision, eye pruritis, foreign body sensation, increased lacrimation, abnormal ocular sensation, eyelid margin crusting, and ocular hyperemia. Postmarketing Experience Additional adverse reactions identified from post-marketing use include corneal erosion, dizziness, eye pain, eyelid ptosis, headache, hypersensitivity reactions, and mydriasis. Frequencies cannot be estimated from the available data. The following additional adverse reactions have been reported with dexamethasone use: Cushing’s syndrome and adrenal suppression may occur after use of dexamethasone in excess of the listed dosing instructions in predisposed patients, including children and patients treated with CYP3A4 inhibitors.
Clinical pharmacology
Information about the clinical pharmacology and actions of the drug in humans.CLINICAL PHARMACOLOGY Dexamethasone suppresses the inflammatory response to a variety of agents and it probably delays or slows healing.
Contraindications
Information about situations in which the drug product is contraindicated or should not be used because the risk of use clearly outweighs any possible benefit, including the type and nature of reactions that have been reported.CONTRAINDICATIONS Contraindicated in acute, untreated bacterial infections; mycobacterial ocular infections; epithelial herpes simplex (dendritic keratitis); vaccinia, varicella, and most other viral diseases of the cornea and conjunctiva; fungal disease of ocular structures; and in those persons who have shown hypersensitivity to any component of this preparation.
Description
General information about the drug product, including the proprietary and established name of the drug, the type of dosage form and route of administration to which the label applies, qualitative and quantitative ingredient information, the pharmacologic or therapeutic class of the drug, and the chemical name and structural formula of the drug.DESCRIPTION MAXIDEX (dexamethasone ophthalmic suspension) 0.1% is an adrenocortical steroid prepared as a sterile topical ophthalmic suspension. The active ingredient is represented by the chemical structure: Chemical name: Pregna-1,4-diene-3,20-dione,9-fluoro-11,17,21-trihydroxy-16-methyl-,(11β,16α)-. Each mL of MAXIDEX (dexamethasone ophthalmic suspension) 0.1% contains: Active: dexamethasone 0.1%. Preservative: benzalkonium chloride 0.01%. Vehicle: hypromellose 0.5%. Inactives: citric acid and/or sodium hydroxide (to adjust pH), dibasic sodium phosphate, edetate disodium, polysorbate 80, purified water, and sodium chloride. chemical
Dosage and administration
Information about the drug product’s dosage and administration recommendations, including starting dose, dose range, titration regimens, and any other clinically sigificant information that affects dosing recommendations.DOSAGE AND ADMINISTRATION SHAKE WELL BEFORE USING. One or two drops topically in the conjunctival sac(s). In severe disease, drops may be used hourly, being tapered to discontinuation as the inflammation subsides. In mild disease, drops may be used up to four to six times daily. Not more than one bottle should be prescribed initially, and the prescription should not be refilled without further evaluation as outlined in PRECAUTIONS above.
Indications and usage
A statement of each of the drug products indications for use, such as for the treatment, prevention, mitigation, cure, or diagnosis of a disease or condition, or of a manifestation of a recognized disease or condition, or for the relief of symptoms associated with a recognized disease or condition. This field may also describe any relevant limitations of use.INDICATIONS AND USAGE Steroid responsive inflammatory conditions of the palpebral and bulbar conjunctiva, cornea, and anterior segment of the globe, such as allergic conjunctivitis, acne rosacea, superficial punctate keratitis, herpes zoster keratitis, iritis, cyclitis, selected infective conjunctivitides when the inherent hazard of steroid use is accepted to obtain an advisable diminution in edema and inflammation; corneal injury from chemical, radiation, or thermal burns, or penetration of foreign bodies.
Spl product data elements
Usually a list of ingredients in a drug product.Maxidex dexamethasone DEXAMETHASONE DEXAMETHASONE BENZALKONIUM CHLORIDE HYPROMELLOSES SODIUM CHLORIDE SODIUM PHOSPHATE, DIBASIC POLYSORBATE 80 EDETATE DISODIUM CITRIC ACID MONOHYDRATE SODIUM HYDROXIDE WATER
Carcinogenesis and mutagenesis and impairment of fertility
Information about carcinogenic, mutagenic, or fertility impairment potential revealed by studies in animals. Information from human data about such potential is part of the warnings field.Carcinogenesis, Mutagenesis, Impairment of Fertility Long-term animal studies have not been performed to evaluate the carcinogenic potential or the effect on fertility of MAXIDEX (dexamethasone ophthalmic suspension) 0.1%.
Package label principal display panel
The content of the principal display panel of the product package, usually including the product’s name, dosage forms, and other key information about the drug product.PRINCIPAL DISPLAY PANEL NDC 0078-0925-25 MAXIDEX ® (dexamethasone ophthalmic suspension) 0.1% 5 mL Sterile NOVARTIS PRINCIPAL DISPLAY PANEL 0078-0925-25 MAXIDEX® (dexamethasone ophthalmic suspension) 0.1% 5 mL Sterile NOVARTIS
Maxidex: Information for patients
Information necessary for patients to use the drug safely and effectively, such as precautions concerning driving or the concomitant use of other substances that may have harmful additive effects.Information for Patients Do not touch dropper tip to any surface, as this may contaminate the contents. The preservative in MAXIDEX (dexamethasone ophthalmic suspension) 0.1%, benzalkonium chloride, may be absorbed by soft contact lenses. MAXIDEX (dexamethasone ophthalmic suspension) 0.1% should not be administered while wearing soft contact lenses.
Geriatric use
Information about any limitations on any geriatric indications, needs for specific monitoring, hazards associated with use of the drug in the geriatric population.Geriatric Use No overall differences in safety or effectiveness have been observed between elderly and younger patients.
Nursing mothers
Information about excretion of the drug in human milk and effects on the nursing infant, including pertinent adverse effects observed in animal offspring.Nursing Mothers Systemically administered corticosteroids appear in human milk and could suppress growth, interfere with endogenous corticosteroid production, or cause other untoward effects. It is not known whether topical administration of corticosteroids could result in sufficient systemic absorption to produce detectable quantities in human milk. Because many drugs are excreted in human milk, caution should be exercised when MAXIDEX (dexamethasone ophthalmic suspension) 0.1% is administered to a nursing woman.
Pediatric use
Information about any limitations on any pediatric indications, needs for specific monitoring, hazards associated with use of the drug in any subsets of the pediatric population (such as neonates, infants, children, or adolescents), differences between pediatric and adult responses to the drug, and other information related to the safe and effective pediatric use of the drug.Pediatric Use The safety and effectiveness of MAXIDEX have been established in the pediatric patients. Use of MAXIDEX in all pediatric age groups is supported by evidence from adequate and well-controlled studies of MAXIDEX in adults with safety data from additional adequate and well-controlled trials in pediatric patients.
Pregnancy
Information about effects the drug may have on pregnant women or on a fetus. This field may be ommitted if the drug is not absorbed systemically and the drug is not known to have a potential for indirect harm to the fetus. It may contain information about the established pregnancy category classification for the drug. (That information is nominally listed in the teratogenic_effects field, but may be listed here instead.)Pregnancy Dexamethasone has been shown to be teratogenic in mice and rabbits following topical ophthalmic application in multiples of the therapeutic dose. In the mouse, corticosteroids produce fetal resorptions and a specific abnormality, cleft palate. In the rabbit, corticosteroids have produced fetal resorptions and multiple abnormalities involving the head, ears, limbs, palate, etc. MAXIDEX (dexamethasone ophthalmic suspension) 0.1% should be used during pregnancy only if the potential benefit to the mother justifies the potential risk to the embryo or fetus. There are no adequate or well-controlled studies in pregnant women. However, prolonged or repeated corticoid use during pregnancy has been associated with an increased risk of intra-uterine growth retardation. Infants born of mothers who have received substantial doses of corticosteroids during pregnancy should be observed carefully for signs of hypoadrenalism.
How supplied
Information about the available dosage forms to which the labeling applies, and for which the manufacturer or distributor is responsible. This field ordinarily includes the strength of the dosage form (in metric units), the units in which the dosage form is available for prescribing, appropriate information to facilitate identification of the dosage forms (such as shape, color, coating, scoring, and National Drug Code), and special handling and storage condition information.HOW SUPPLIED MAXIDEX ® (dexamethasone ophthalmic suspension) 0.1% in plastic dispensers: 5 mL NDC 0078-0925-25 STORAGE: Store upright at 8°C to 27°C (46°F to 80°F). After opening, MAXIDEX can be used until the expiration date on the bottle. © Novartis Distributed by: Novartis Pharmaceuticals Corporation East Hanover, New Jersey 07936 Revised: January 2022 T2022-01
General precautions
Information about any special care to be exercised for safe and effective use of the drug.General FOR TOPICAL OPHTHALMIC USE. The possibility of persistent fungal infections of the cornea should be considered after prolonged corticosteroid dosing. The initial prescription and renewal of the medication order should be made by a physician only after examination of the patient with the aid of magnification, such as slit lamp biomicroscopy and, where appropriate, fluorescein staining. If signs and symptoms fail to improve after 2 days, the patient should be re-evaluated.
Precautions
Information about any special care to be exercised for safe and effective use of the drug.PRECAUTIONS General FOR TOPICAL OPHTHALMIC USE. The possibility of persistent fungal infections of the cornea should be considered after prolonged corticosteroid dosing. The initial prescription and renewal of the medication order should be made by a physician only after examination of the patient with the aid of magnification, such as slit lamp biomicroscopy and, where appropriate, fluorescein staining. If signs and symptoms fail to improve after 2 days, the patient should be re-evaluated. Information for Patients Do not touch dropper tip to any surface, as this may contaminate the contents. The preservative in MAXIDEX (dexamethasone ophthalmic suspension) 0.1%, benzalkonium chloride, may be absorbed by soft contact lenses. MAXIDEX (dexamethasone ophthalmic suspension) 0.1% should not be administered while wearing soft contact lenses. Carcinogenesis, Mutagenesis, Impairment of Fertility Long-term animal studies have not been performed to evaluate the carcinogenic potential or the effect on fertility of MAXIDEX (dexamethasone ophthalmic suspension) 0.1%. Pregnancy Dexamethasone has been shown to be teratogenic in mice and rabbits following topical ophthalmic application in multiples of the therapeutic dose. In the mouse, corticosteroids produce fetal resorptions and a specific abnormality, cleft palate. In the rabbit, corticosteroids have produced fetal resorptions and multiple abnormalities involving the head, ears, limbs, palate, etc. MAXIDEX (dexamethasone ophthalmic suspension) 0.1% should be used during pregnancy only if the potential benefit to the mother justifies the potential risk to the embryo or fetus. There are no adequate or well-controlled studies in pregnant women. However, prolonged or repeated corticoid use during pregnancy has been associated with an increased risk of intra-uterine growth retardation. Infants born of mothers who have received substantial doses of corticosteroids during pregnancy should be observed carefully for signs of hypoadrenalism. Nursing Mothers Systemically administered corticosteroids appear in human milk and could suppress growth, interfere with endogenous corticosteroid production, or cause other untoward effects. It is not known whether topical administration of corticosteroids could result in sufficient systemic absorption to produce detectable quantities in human milk. Because many drugs are excreted in human milk, caution should be exercised when MAXIDEX (dexamethasone ophthalmic suspension) 0.1% is administered to a nursing woman. Pediatric Use The safety and effectiveness of MAXIDEX have been established in the pediatric patients. Use of MAXIDEX in all pediatric age groups is supported by evidence from adequate and well-controlled studies of MAXIDEX in adults with safety data from additional adequate and well-controlled trials in pediatric patients. Geriatric Use No overall differences in safety or effectiveness have been observed between elderly and younger patients.
Warnings
Information about serious adverse reactions and potential safety hazards, including limitations in use imposed by those hazards and steps that should be taken if they occur.WARNINGS Prolonged use may result in ocular hypertension and/or glaucoma, with damage to the optic nerve, defects in visual acuity and fields of vision, and posterior subcapsular cataract formation. Prolonged use may suppress the host response and thus increase the hazard of secondary ocular infections. In acute purulent conditions or parasitic infections of the eye, corticosteroids may mask infection or enhance existing infection. In those diseases causing thinning of the cornea or sclera, perforations have been known to occur with the use of topical corticosteroids. If these products are used for 10 days or longer, intraocular pressure (IOP) should be routinely monitored even though it may be difficult in children and uncooperative patients. Employment of corticosteroid medication in the treatment of herpes simplex other than epithelial herpes simplex keratitis, in which it is contraindicated, requires great caution; periodic slit-lamp microscopy is essential.
Disclaimer: Do not rely on openFDA or Phanrmacy Near Me to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Source: OpenFDA, Healthporta Drugs API