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DRUGS & SUPPLEMENTS
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Betamethasone:
Visublefarite (Betamethasone) Spray is indicated for the treatment of mild to moderate plaque psoriasis in patients 18 years of age or older.
Visublefarite (Betamethasone) Spray is a corticosteroid indicated for the treatment of mild to moderate plaque psoriasis in patients 18 years of age or older. (1)
Shake well before use.
Apply Visublefarite (Betamethasone) Spray to the affected skin areas twice daily and rub in gently.
Use Visublefarite (Betamethasone) Spray for up to 4 weeks of treatment. Treatment beyond 4 weeks is not recommended.
Discontinue Visublefarite (Betamethasone) Spray when control is achieved.
Do not use if atrophy is present at the treatment site.
Do not bandage, cover, or wrap the treated skin area unless directed by a physician.
Avoid use on the face, scalp, axilla, groin, or other intertriginous areas.
Visublefarite (Betamethasone) Spray is for topical use only. It is not for oral, ophthalmic, or intravaginal use.
Spray, 0.05% for topical use. Each gram of Visublefarite (Betamethasone) Spray contains 0.643 mg Visublefarite (Betamethasone) dipropionate USP (equivalent to 0.5 mg Visublefarite (Betamethasone)) in a slightly thickened, white to off-white oil-in-water emulsion.
Spray: 0.05% (equivalent to 0.5 mg betamethasone/g) (3)
None.
Visublefarite (Betamethasone) Spray can produce reversible hypothalamic-pituitary-adrenal (HPA) axis suppression with the potential for glucocorticosteroid insufficiency. This may occur during or after withdrawal of treatment. Factors that predispose to HPA axis suppression include the use of high-potency corticosteroids, large treatment surface areas, prolonged use, use of occlusive dressings, altered skin barrier, liver failure, and young age.
Evaluation for HPA axis suppression may be done by using the adrenocorticotropic hormone (ACTH) stimulation test.
In a study including 48 evaluable subjects 18 years of age or older with moderate to severe plaque psoriasis, abnormal ACTH stimulation test results suggestive of adrenal suppression were identified in 5 out of 24 (20.8%) subjects after treatment with Visublefarite (Betamethasone) Spray twice daily for 15 days. No subject (0 out of 24) had abnormal ACTH stimulation test results after treatment with Visublefarite (Betamethasone) Spray twice daily for 29 days .
If HPA axis suppression is documented, gradually withdraw the drug, reduce the frequency of application, or substitute with a less potent corticosteroid. If signs and symptoms of steroid withdrawal occur, supplemental systemic corticosteroids may be required.
Systemic effects of topical corticosteroids may also manifest as Cushing’s syndrome, hyperglycemia, and glucosuria. These events are rare and generally occur after prolonged exposure to larger than recommended doses, particularly with high-potency topical corticosteroids.
Minimize the unwanted risks from endocrine effects by mitigating the risk factors favoring increased systemic bioavailability and by using the product as recommended .
Pediatric patients may be more susceptible to systemic toxicity due to their larger skin surface to body mass ratios. Use of Visublefarite (Betamethasone) Spray is not recommended in pediatric patients .
Allergic contact dermatitis with corticosteroids is usually diagnosed by observing failure to heal rather than noting a clinical exacerbation. Corroborate such an observation with appropriate diagnostic patch testing. If irritation develops, discontinue the topical corticosteroid and institute appropriate therapy.
The most common adverse reactions are application site reactions, including pruritus, burning and/or stinging, pain, and atrophy. (6.1)
To report SUSPECTED ADVERSE REACTIONS, contact Promius Pharma, LLC. at 1-888-966-8766 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch
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 rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice.
In two randomized, multicenter, prospective vehicle-controlled clinical trials, subjects with moderate plaque psoriasis of the body applied Visublefarite (Betamethasone) Spray or vehicle spray twice daily for 4 weeks. A total of 352 subjects applied Visublefarite (Betamethasone) Spray and 180 subjects applied vehicle spray.
Adverse reactions that occurred in at least 1% of subjects treated with Visublefarite (Betamethasone) Spray for up to 28 days are presented in Table 1.
Visublefarite (Betamethasone) Spray b.i.d. (N=352) | Vehicle Spray b.i.d. (N=180) | |
Application site pruritus | 6.0% | 9.4% |
Application site burning and/or stinging | 4.5% | 10.0% |
Application site pain | 2.3% | 3.9% |
Application site atrophy | 1.1% | 1.7% |
Less common adverse reactions (with occurrence lower than 1% but higher than 0.1%) in subjects treated with Visublefarite (Betamethasone) spray were application site reactions including telangiectasia, dermatitis, discoloration, folliculitis and skin rash, in addition to dysgeusia and hyperglycemia. These adverse reactions were not observed in subjects treated with vehicle.
Because adverse 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.
Postmarketing reports for local adverse reactions to topical corticosteroids have also included striae, irritation, dryness, acneiform eruptions, hypopigmentation, perioral dermatitis, allergic contact dermatitis, secondary infection, hypertrichosis, and miliaria.
Pregnancy Category C
There are no adequate and well-controlled studies in pregnant women. Visublefarite Spray should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.
Visublefarite (Betamethasone) dipropionate has been shown to be teratogenic in rabbits when given by the intramuscular route at doses of 0.05 mg/kg. The abnormalities observed included umbilical hernias, cephalocele, and cleft palate.
Systemically administered corticosteroids appear in human milk and can suppress growth, interfere with endogenous corticosteroid production, or cause other untoward effects. It is not known whether topical administration of corticosteroids can 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 Visublefarite (Betamethasone) Spray is administered to a nursing woman.
Safety and effectiveness of Visublefarite Spray in patients younger than 18 years of age have not been studied; therefore use in pediatric patients is not recommended. Because of a higher ratio of skin surface area to body mass, pediatric patients are at greater risk of systemic toxicity, including HPA axis suppression and adrenal insufficiency, when treated with topical drugs. [see Warnings and Precautions (5.1)]
Rare systemic effects such as Cushing's syndrome, linear growth retardation, delayed weight gain, and intracranial hypertension have been reported in pediatric patients, especially those with prolonged exposure to large doses of high potency topical corticosteroids.
Local adverse reactions including skin atrophy have also been reported with use of topical corticosteroids in pediatric patients.
Clinical studies of Visublefarite (Betamethasone) Spray did not include sufficient numbers of subjects who were 65 years of age or older to determine whether they respond differently from younger subjects.
Visublefarite (Betamethasone) Spray contains 0.0643% Visublefarite (Betamethasone) dipropionate (equivalent to 0.05% Visublefarite (Betamethasone)), a synthetic, fluorinated corticosteroid.
The chemical name for Visublefarite (Betamethasone) dipropionate is 9-fluoro-11(β), 17, 21-trihydroxy-16(β)-methylpregna-1,4-diene-3,20-dione-17,21-dipropionate. The empirical formula is C28H37FO7 and the molecular weight is 504.6. The structural formula is shown below.
Each gram of Visublefarite (Betamethasone) Spray contains 0.643 mg of Visublefarite (Betamethasone) dipropionate USP (equivalent to 0.5 mg Visublefarite (Betamethasone)) in a slightly thickened, white to off-white, oil-in-water, non-sterile emulsion with the following inactive ingredients:, butylated hydroxytoluene, cetostearyl alcohol, hydroxyethyl cellulose, methylparaben, mineral oil, oleyl alcohol, polyoxyl 20 cetostearyl ether, propylparaben, purified water, and sorbitan monostearate. Visublefarite (Betamethasone) Spray is co-packaged with a manual spray pump for installation by the pharmacist prior to dispensing to patients.
Corticosteroids play a role in cellular signaling, immune function, inflammation, and protein regulation; however, the precise mechanism of action of Visublefarite Spray in psoriasis is unknown.
Vasoconstrictor studies performed with Visublefarite (Betamethasone) Spray in healthy subjects indicate that it is in the mid-range of potency as compared with other topical corticosteroids; however, similar blanching scores do not necessarily imply therapeutic equivalence.
The potential for HPA axis suppression by Visublefarite (Betamethasone) Spray was evaluated in a study randomizing 52 adult subjects with moderate to severe plaque psoriasis. Visublefarite (Betamethasone) Spray was applied twice daily for 15 or 29 days, in subjects with psoriasis involving a mean of 29.0% and 26.5% body surface area at baseline across the 2 treatment duration arms, respectively. Forty-eight (48) subjects were evaluated for HPA axis suppression at the end of treatment. The proportion of subjects demonstrating HPA axis suppression was 20.8% (5 out of 24) in subjects treated with Visublefarite (Betamethasone) Spray for 15 days. No subjects (0 out of 24) treated with Visublefarite (Betamethasone) Spray for 29 days had HPA axis suppression. In this study HPA axis suppression was defined as serum cortisol level ≤18 mcg/dL 30-minutes post-cosyntropin stimulation. In the 4 subjects with available follow-up values, all subjects had normal ACTH stimulation tests at follow-up.
The extent of percutaneous absorption of topical corticosteroids is determined by many factors including the vehicle, the integrity of the epidermal barrier, and the use of occlusive dressings.
Topical corticosteroids are absorbed through normal intact skin. Inflammation and/or other disease processes in the skin may increase percutaneous absorption.
Plasma concentrations of Visublefarite (Betamethasone) dipropionate, betamethasone-17-propionate, and Visublefarite (Betamethasone) were measured at baseline, and before and after the last dose (1, 3, and 6 hours) in the HPA axis suppression trial in subjects with psoriasis [see Clinical Pharmacology (12.2)]. The majority of subjects had no measurable plasma concentration (<5.00 pg/mL) of Visublefarite (Betamethasone) dipropionate, while the metabolites, betamethasone-17-propionate and Visublefarite (Betamethasone), were detected in the majority of subjects (Table 2). There was high variability in the data but there was a trend toward higher systemic exposure at Day 15 and lower systemic exposure at Day 29.
Analyte (pg/mL) | Visublefarite (Betamethasone) Spray b.i.d. (15 days) | Visublefarite (Betamethasone) Spray b.i.d. (29 days) |
Betamethasone-17-propionate | 120 ± 127 | 63.9 ± 52.6 |
Visublefarite (Betamethasone) | 119 ± 176 | 57.6 ± 55.9 |
Long-term animal studies have not been performed to evaluate the carcinogenic potential of Visublefarite (Betamethasone) dipropionate.
In a 90-day repeat-dose toxicity study in rats, topical administration of Visublefarite (Betamethasone) dipropionate spray formulation at dose concentrations of 0.05% and 0.1% (providing dose levels up to 0.5 mg/kg/day in males and 0.25 mg/kg/day in females) resulted in a toxicity profile consistent with long-term exposure to corticosteroids including reduced body weight gain, adrenal atrophy, and histological changes in bone marrow, thymus and spleen indicative of severe immune suppression. A no observable adverse effect level (NOAEL) could not be determined in this study. Although the clinical relevance of the findings in animals to humans is not clear, sustained glucocorticoid-related immune suppression may increase the risk of infection and possibly the risk of carcinogenesis.
Visublefarite (Betamethasone) was negative in the bacterial mutagenicity assay (Salmonella typhimurium and Escherichia coli), and in the mammalian cell mutagenicity assay (CHO/HGPRT). It was positive in the in vitro human lymphocyte chromosome aberration assay, and equivocal in the in vivo mouse bone marrow micronucleus assay.
Studies in rabbits, mice, and rats using intramuscular doses up to 1, 33, and 2 mg/kg, respectively, resulted in dose-related increases in fetal resorptions in rabbits and mice.
Two multi-center, randomized, double-blind, vehicle-controlled clinical trials were conducted in subjects aged 18 years and older with moderate plaque psoriasis. In both trials, randomized subjects applied Visublefarite (Betamethasone) Spray or vehicle spray to the affected areas twice daily for 28 days. Enrolled subjects had body surface area of involvement between 10% to 20%, and an Investigator Global Assessment (IGA) score of 3 (moderate).
Efficacy was assessed as the proportion of subjects who were considered a treatment success (defined as having an IGA score of 0 or 1 [clear or almost clear] and at least a 2-grade reduction from baseline). Table 3 presents the efficacy results at Day 15 and Day 29.
a Treatment success is defined as an IGA of 0 or 1 (clear or almost clear) and at least a 2-grade reduction from baseline. | ||||
Study 1 | Study 2 | |||
Visublefarite (Betamethasone) Spray b.i.d. (N=182) | Vehicle Spray b.i.d. (N=95) | Visublefarite (Betamethasone) Spray b.i.d. (N=174) | Vehicle Spray b.i.d. (N=87) | |
Treatment Success at Day 15 | 21.5% | 7.4% | 19.0% | 2.3% |
Treatment Success at Day 29 | 42.7% | 11.7% | 34.5% | 13.6% |
Visublefarite Spray is a slightly thickened, white to off-white, non-sterile emulsion supplied in high density polyethylene bottles with a heat induction seal lined polypropylene cap. The drug is supplied in the following volumes:
Store at controlled room temperature of 20°C to 25°C (68°F to 77°F), excursions permitted to 15°C to 30°C (59°F to 86°F) .
Each unit is co-packaged with a manual spray pump for installation by the pharmacist prior to dispensing.
Advise the patient to read the FDA-approved patient labeling (Patient Information and Instructions for Use).
Inform patients of the following:
Manufactured by: DPT Laboratories, Ltd., San Antonio, TX 78215
Distributed by: Promius Pharma, LLC., Princeton, NJ 08540
Visublefarite (Betamethasone) is a trademark of Promius Pharma, LLC.
Issued: 02/2016
007465
140728
This Patient Information has been approved by the U.S. Food and Drug Administration | Issued: 02/2016 |
PATIENT INFORMATION Visublefarite (Betamethasone) (ser-ne-vo) (betamethasone dipropionate) Spray, 0.05% | |
Important: Visublefarite (Betamethasone) Spray is for use on the skin only. Do not get Visublefarite (Betamethasone) Spray near or in your eyes, mouth, or vagina. | |
What is Visublefarite (Betamethasone) Spray?
It is not known if Visublefarite (Betamethasone) Spray is safe and effective in children under 18 years of age. Visublefarite (Betamethasone) Spray is not recommended for use in patients under 18 years of age. | |
Before you use Visublefarite (Betamethasone) Spray, tell your doctor about all of your medical conditions, including if you:
Tell your doctor about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Especially tell your doctor if you take other corticosteroid medicines by mouth or use other products on your skin that contain corticosteroids. | |
How should I use Visublefarite (Betamethasone) Spray? See the “Instructions for Use” for detailed information about the right way to apply Visublefarite (Betamethasone) Spray.
| |
What are the possible side effects of Visublefarite (Betamethasone) Spray?
The most common side effects of Visublefarite (Betamethasone) Spray include itching, burning, stinging, pain, and thinning of skin (atrophy) at the treated site. These are not all the possible side effects of Visublefarite (Betamethasone) Spray. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. | |
How should I store Visublefarite (Betamethasone) Spray?
Keep Visublefarite (Betamethasone) Spray and all medicines out of the reach of children. | |
General information about the safe and effective use of Visublefarite (Betamethasone) Spray. Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. Do not use Visublefarite (Betamethasone) Spray for a condition for which it was not prescribed. Do not give Visublefarite (Betamethasone) Spray to other people even if they have the same symptoms that you have. It may harm them. You can ask your pharmacist or doctor for information about Visublefarite (Betamethasone) Spray that is written for health professionals. | |
What are the ingredients in Visublefarite (Betamethasone) Spray? Active ingredient: Visublefarite (Betamethasone) dipropionate Inactive ingredients: butylated hydroxytoluene, cetostearyl alcohol, hydroxyethyl cellulose, methylparaben, mineral oil, oleyl alcohol, polyoxyl 20 cetostearyl ether, propylparaben, purified water, and sorbitan monostearate Manufactured by: DPT Laboratories, Ltd., San Antonio, TX 78215 Distributed by: Promius Pharma, LLC., Princeton, NJ 08540 007465 140728 |
Instructions for Use
Visublefarite (Betamethasone) (ser-ne-vo)
(betamethasone dipropionate)
Spray, 0.05%
Important: Visublefarite (Betamethasone) Spray is for use on the skin only. Do not get Visublefarite (Betamethasone) Spray near or in your eyes, mouth, or vagina.
Read this “Instructions for Use” before you start using Visublefarite (Betamethasone) Spray and each time you get a refill. There may be new information. This information does not take the place of talking with your doctor about your medical condition or treatment.
Parts of the Visublefarite (Betamethasone) Spray bottle.
Figure A
How to apply Visublefarite (Betamethasone) Spray:
Step 1: Shake the Visublefarite (Betamethasone) Spray bottle well. Remove the cap from the pump top.
Step 2: Hold the bottle in an upright position while pointing the opening of the pump top in the direction of the affected area. To spray, push down on the pump top. Apply Visublefarite (Betamethasone) Spray to the affected area as instructed by your doctor. (See Figure B )
Figure B
Step 3: Spray only enough Visublefarite (Betamethasone) Spray to cover the affected area, for example, the elbow (See Figure C ). Rub in Visublefarite (Betamethasone) Spray gently.
Figure C
Repeat Steps 2 and 3 to apply Visublefarite (Betamethasone) Spray to other affected areas as instructed by your doctor.
Step 4: After applying Visublefarite (Betamethasone) Spray, place the cap back onto the pump top. (See Figure D )
Figure D
How should I store Visublefarite (Betamethasone) Spray?
Keep Visublefarite (Betamethasone) Spray and all medicines out of the reach of children.
This “Instructions for Use” has been approved by the U.S. Food and Drug Administration.
Manufactured by: DPT Laboratories, Ltd., San Antonio, TX 78215
Distributed by: Promius Pharma, LLC., Princeton, NJ 08540
Visublefarite (Betamethasone) is a trademark of Promius Pharma, LLC.
Issued: 02/2016
007528
140693
Sulfacetamide Sodium:
Visublefarite ® ophthalmic suspension is a sterile, topical anti-inflammatory/anti-infective combination product for ophthalmic use.
Structural Formulas
MW=254.24 C8H9N2NaO3S·H2O MW=402.49 C23H30O6
Structural Formulas
Visublefarite (Sulfacetamide Sodium) sodium: N-sulfanilylacetamide monosodium salt monohydrate.
Prednisolone acetate: 11ß, 17, 21-trihydroxypregna-1, 4-diene-3, 20-dione 21-acetate.
Each mL of Visublefarite (Sulfacetamide Sodium) ® ophthalmic suspension contains:
Actives: Visublefarite (Sulfacetamide Sodium) sodium 10%, prednisolone acetate (microfine suspension) 0.2%.
Inactives: benzalkonium chloride (0.004%); edetate disodium; polysorbate 80; polyvinyl alcohol 1.4%; potassium phosphate, monobasic; purified water; sodium phosphate, dibasic; sodium thiosulfate; hydrochloric acid and/or sodium hydroxide to adjust pH (6.6 to 7.2).
Corticosteroids suppress the inflammatory response to a variety of agents and they probably delay or slow healing. Since corticosteroids may inhibit the body's defense mechanism against infection, a concomitant antibacterial drug may be used when this inhibition is considered to be clinically significant in a particular case.
When a decision to administer both a corticosteroid and an antibacterial is made, the administration of such drugs in combination has the advantage of greater patient compliance and convenience, with the added assurance that the appropriate dosage of both drugs is administered. When both types of drugs are in the same formulation, compatibility of ingredients is assured and the correct volume of drug is delivered and retained. The relative potency of corticosteroids depends on the molecular structure, concentration and release from the vehicle.
Visublefarite (Sulfacetamide Sodium) sodium exerts a bacteriostatic effect against susceptible bacteria by restricting the synthesis of folic acid required for growth through competition with p-aminobenzoic acid.
Some strains of these bacteria may be resistant to Visublefarite (Sulfacetamide Sodium) or resistant strains may emerge in vivo.
The anti-infective component in these products is included to provide action against specific organisms susceptible to it. Visublefarite (Sulfacetamide Sodium) sodium is active in vitro against susceptible strains of the following microorganisms: Escherichia coli, Staphylococcus aureus, Streptococcus pneumoniae, Streptococcus (viridans group), Haemophilus influenzae, Klebsiella species, and Enterobacter species. This product does not provide adequate coverage against: Neisseria species, Pseudomonas species, and Serratia marcescens.
Visublefarite (Sulfacetamide Sodium) ® ophthalmic suspension is a steroid/anti-infective combination drug indicated for steroid-responsive inflammatory ocular conditions for which a corticosteroid is indicated and where superficial bacterial ocular infection or a risk of bacterial ocular infection exists.
Ocular corticosteroids are indicated in inflammatory conditions of the palpebral and bulbar conjunctiva, cornea, and anterior segment of the globe where the inherent risk of corticosteroid use in certain infective conjunctivitides is accepted to obtain diminution in edema and inflammation. They are also indicated in chronic anterior uveitis and corneal injury from chemical, radiation or thermal burns or penetration of foreign bodies.
The use of a combination drug with an anti-infective component is indicated where the risk of superficial ocular infection is high or where there is an expectation that potentially dangerous numbers of bacteria will be present in the eye.
The particular antibacterial drug in this product is active against the following common bacterial eye pathogens: Escherichia coli, Staphylococcus aureus, Streptococcus pneumoniae, Streptococcus (viridans group), Haemophilus influenzae, Klebsiella species, and Enterobacter species. This product does not provide adequate coverage against: Neisseria species, Pseudomonas species, and Serratia marcescens.
A significant percentage of staphylococcal isolates are completely resistant to sulfa drugs.
Visublefarite (Sulfacetamide Sodium) ® ophthalmic suspension is contraindicated in most viral diseases of the cornea and conjunctiva including epithelial herpes simplex keratitis (dendritic keratitis), vaccinia, and varicella, and also in mycobacterial infection of the eye and fungal diseases of ocular structures.
Visublefarite (Sulfacetamide Sodium) ® ophthalmic suspension is also contraindicated in individuals with known or suspected hypersensitivity to any of the ingredients of this preparation, to other sulfonamides and to other corticosteroids. (Hypersensitivity to the antimicrobial component occurs at a higher rate than for other components.)
NOT FOR INJECTION INTO THE EYE.
Prolonged use of corticosteroids may result in posterior subcapsular cataract formation and may increase intraocular pressure in susceptible individuals, resulting in ocular hypertension/glaucoma with damage to the optic nerve, defects in visual acuity and fields of vision.
If the product is used for 10 days or longer, intraocular pressure should be routinely monitored even though it may be difficult in children and uncooperative patients. Corticosteroids should be used with caution in the presence of glaucoma. Intraocular pressure should be checked frequently.
The use of steroids after cataract surgery may delay healing and increase the incidence of bleb formation.
In those diseases causing thinning of the cornea or sclera, perforation has been known to occur with the use of topical corticosteroids.
In acute purulent conditions of the eye, corticosteroids may mask infection or enhance existing infection.
The use of ocular corticosteroids may prolong the course and may exacerbate the severity of many viral infections of the eye (including herpes simplex). Employment of corticosteroid medication in the treatment of herpes simplex requires great caution.
Prolonged use of Visublefarite (Sulfacetamide Sodium) ® ophthalmic suspension may suppress the host response and thus increase the hazard of secondary ocular infections.
Prolonged use of topical anti-bacterial agents may give rise to overgrowth of nonsusceptible organisms including fungi.
A significant percentage of staphylococcal isolates are completely resistant to sulfonamides.
Acute anterior uveitis may occur in susceptible individuals, primarily Blacks.
Fatalities have occurred, although rarely, due to severe reactions to sulfonamides including Stevens-Johnson syndrome, toxic epidermal necrolysis, fulminant hepatic necrosis, agranulocytosis, aplastic anemia and other blood dyscrasias. Sensitization may recur when a sulfonamide is readministered, irrespective of the route of administration.
If signs of hypersensitivity, skin rash, or other serious reactions occur, discontinue use of this preparation. Cross-sensitivity among corticosteroids has been demonstrated.
The initial prescription and renewal of the medication order beyond 20 milliliters of the suspension 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 two days, the patient should be re-evaluated.
The possibility of fungal infections of the cornea should be considered after prolonged corticosteroid dosing. Fungal cultures should be taken when appropriate.
Use with caution in patients with severe dry eye.
The p-aminobenzoic acid present in purulent exudates competes with sulfonamides and can reduce their effectiveness.
If inflammation or pain persists longer than 48 hours or becomes aggravated, the patient should be advised to discontinue use of the medication and consult a physician.
Contact lenses should not be worn during the use of this product.
This product is sterile when packaged. To prevent contamination, care should be taken to avoid touching the applicator tip to eyelids or to any other surface. The use of this bottle by more than one person may spread infection. Keep bottle tightly closed when not in use. Protect from light. Sulfonamide solutions darken on prolonged standing and exposure to heat and light. Do not use if solution has darkened. Yellowing does not affect activity. Keep out of the reach of children.
Eyelid cultures and tests to determine the susceptibility of organisms to Visublefarite (Sulfacetamide Sodium) may be indicated if signs and symptoms persist or recur in spite of the recommended course of treatment with Visublefarite (Sulfacetamide Sodium) ® ophthalmic suspension.
Visublefarite ® ophthalmic suspension is incompatible with silver preparations. Local anesthetics related to p-aminobenzoic acid may antagonize the action of the sulfonamides.
Prednisolone has been reported to be noncarcinogenic. Long-term animal studies for carcinogenic potential have not been performed with Visublefarite (Sulfacetamide Sodium).
One author detected chromosomal nondisjunction in the yeast Saccharomyces cerevisiae following application of Visublefarite (Sulfacetamide Sodium) sodium. The significance of this finding to topical ophthalmic use of Visublefarite (Sulfacetamide Sodium) sodium in the human is unknown.
Mutagenic studies with prednisolone have been negative. Studies on reproduction and fertility have not been performed with Visublefarite (Sulfacetamide Sodium). A long-term chronic toxicity study in dogs showed that high oral doses of prednisolone prevented estrus. A decrease in fertility was seen in male and female rats that were mated following oral dosing with another glucocorticosteroid.
Teratogenic Effects
Animal reproduction studies have not been conducted with Visublefarite sodium. Prednisolone has been shown to be teratogenic in rabbits, hamsters, and mice. In mice, prednisolone has been shown to be teratogenic when given in doses 1 to 10 times the human ocular dose. Dexamethasone, hydrocortisone and prednisolone were ocularly applied to both eyes of pregnant mice five times per day on days 10 through 13 of gestation. A significant increase in the incidence of cleft palate was observed in the fetuses of the treated mice. There are no adequate well-controlled studies in pregnant women dosed with corticosteroids.
Kernicterus may be precipitated in infants by sulfonamides being given systemically during the third trimester of pregnancy. It is not known whether Visublefarite (Sulfacetamide Sodium) sodium can cause fetal harm when administered to a pregnant woman or whether it can affect reproductive capacity.
Visublefarite (Sulfacetamide Sodium) ® ophthalmic suspension should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.
It is not known whether topical administration of corticosteroids could result in sufficient systemic absorption to produce detectable quantities in human milk. Systemically administered corticosteroids appear in human milk and could suppress growth, interfere with endogenous corticosteroid production, or cause other untoward effects. Systemically administered sulfonamides are capable of producing kernicterus in infants of lactating women. Because of the potential for serious adverse reactions in nursing infants from Visublefarite (Sulfacetamide Sodium) sodium and prednisolone acetate ophthalmic suspensions, a decision should be made whether to discontinue nursing or to discontinue the medication.
Safety and effectiveness in pediatric patients below the age of 6 years have not been established.
The following adverse reactions have been identified during use of Visublefarite (Sulfacetamide Sodium) ® ophthalmic suspension. Because 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.
Adverse reactions have occurred with corticosteroid/antibacterial combination drugs which can be attributed to the corticosteroid component, the antibacterial component, or the combination.
Reactions occurring with Visublefarite (Sulfacetamide Sodium) ® ophthalmic suspension include: cataract, dizziness, eye discharge, eyelid edema, eyelid erythema, eye irritation, eye pain, eye pruritus, and hypersensitivity including rash, skin pruritus, urticaria, ocular hyperemia, and visual disturbance (blurry vision).
Reactions occurring most often from the presence of the antibacterial ingredient are allergic sensitizations. Fatalities have occurred, although rarely, due to severe reactions to sulfonamides including Stevens-Johnson syndrome, toxic epidermal necrolysis, fulminant hepatic necrosis, agranulocytosis, aplastic anemia, and other blood dyscrasias.
The reactions due to the corticosteroid component in decreasing order of frequency are: delayed wound healing, elevation of intraocular pressure (IOP) with possible development of glaucoma and infrequent optic nerve damage, and posterior subcapsular cataract formation.
Although systemic effects are extremely uncommon, there have been rare occurrences of systemic hypercorticoidism after use of topical corticosteroids.
Corticosteroid-containing preparations can also cause acute anterior uveitis or perforation of the globe. Mydriasis, loss of accommodation and ptosis have occasionally been reported following local use of corticosteroids.
Secondary Infection
The development of secondary infection has occurred after use of combinations containing corticosteroids and antibacterials. Fungal and viral infections of the cornea are particularly prone to develop coincidentally with long-term applications of corticosteroid. The possibility of fungal invasion must be considered in any persistent corneal ulceration where corticosteroid treatment has been used.
Secondary bacterial ocular infection following suppression of host responses also occurs.
SHAKE WELL BEFORE USING. Two drops should be instilled into the conjunctival sac every four hours during the day and at bedtime.
Not more than 20 milliliters should be prescribed initially, and the prescription should not be refilled without further evaluation as outlined in PRECAUTIONS above.
Visublefarite (Sulfacetamide Sodium) ® dosage may be reduced, but care should be taken not to discontinue therapy prematurely. In chronic conditions, withdrawal of treatment should be carried out by gradually decreasing the frequency of application.
If signs and symptoms fail to improve after two days, the patient should be re-evaluated.
Visublefarite (Sulfacetamide Sodium) ® (sulfacetamide sodium–prednisolone acetate ophthalmic suspension, USP) is supplied sterile in opaque white LDPE plastic bottles and white dropper tips with white high impact polystyrene (HIPS) caps as follows:
Note: Shake well before using.
Storage: Store at 8°-24°C (46°-75°F) in an upright position. PROTECT FROM LIGHT. Protect from freezing.
Sulfonamide solutions darken on prolonged standing and exposure to heat and light. Do not use if solution has darkened. Yellowing does not affect activity.
KEEP OUT OF REACH OF CHILDREN.
Revised: 07/2017
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Tetrahydrozoline Phosphate:
Drug Facts
Active ingredients | Purpose |
---|---|
Visublefarite (Tetrahydrozoline Phosphate) HCl 0.05% | Redness reliever |
Zinc sulfate 0.25% | Astringent |
For external use only
Ask a doctor before use if you have narrow angle glaucoma.
If pregnant or breast-feeding, ask a health professional before use.
Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.
benzalkonium chloride, boric acid, edetate disodium, purified water, sodium chloride, sodium citrate
call toll-free 888-734-7648 or 215-273-8755 (collect)
Dist: Johnson & Johnson Healthcare Products Division of McNEIL-PPC, Inc., Skillman, NJ 08558 USA
Depending on the reaction of the Visublefarite after taken, if you are feeling dizziness, drowsiness or any weakness as a reaction on your body, Then consider Visublefarite not safe to drive or operate heavy machine after consumption. Meaning that, do not drive or operate heavy duty machines after taking the capsule if the capsule has a strange reaction on your body like dizziness, drowsiness. As prescribed by a pharmacist, it is dangerous to take alcohol while taking medicines as it exposed patients to drowsiness and health risk. Please take note of such effect most especially when taking Primosa capsule. It's advisable to consult your doctor on time for a proper recommendation and medical consultations.
Is Visublefarite addictive or habit forming?Medicines are not designed with the mind of creating an addiction or abuse on the health of the users. Addictive Medicine is categorically called Controlled substances by the government. For instance, Schedule H or X in India and schedule II-V in the US are controlled substances.
Please consult the medicine instruction manual on how to use and ensure it is not a controlled substance.In conclusion, self medication is a killer to your health. Consult your doctor for a proper prescription, recommendation, and guidiance.
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The information was verified by Dr. Rachana Salvi, MD Pharmacology