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DRUGS & SUPPLEMENTS
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How is the drug helping you? |
Betamethasone:
Flunec Cream (Betamethasone) Spray is indicated for the treatment of mild to moderate plaque psoriasis in patients 18 years of age or older.
Flunec Cream (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 Flunec Cream (Betamethasone) Spray to the affected skin areas twice daily and rub in gently.
Use Flunec Cream (Betamethasone) Spray for up to 4 weeks of treatment. Treatment beyond 4 weeks is not recommended.
Discontinue Flunec Cream (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.
Flunec Cream (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 Flunec Cream (Betamethasone) Spray contains 0.643 mg Flunec Cream (Betamethasone) dipropionate USP (equivalent to 0.5 mg Flunec Cream (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.
Flunec Cream (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 Flunec Cream (Betamethasone) Spray twice daily for 15 days. No subject (0 out of 24) had abnormal ACTH stimulation test results after treatment with Flunec Cream (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 Flunec Cream (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 Flunec Cream (Betamethasone) Spray or vehicle spray twice daily for 4 weeks. A total of 352 subjects applied Flunec Cream (Betamethasone) Spray and 180 subjects applied vehicle spray.
Adverse reactions that occurred in at least 1% of subjects treated with Flunec Cream (Betamethasone) Spray for up to 28 days are presented in Table 1.
Flunec Cream (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 Flunec Cream (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. Flunec Cream Spray should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.
Flunec Cream (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 Flunec Cream (Betamethasone) Spray is administered to a nursing woman.
Safety and effectiveness of Flunec Cream 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 Flunec Cream (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.
Flunec Cream (Betamethasone) Spray contains 0.0643% Flunec Cream (Betamethasone) dipropionate (equivalent to 0.05% Flunec Cream (Betamethasone)), a synthetic, fluorinated corticosteroid.
The chemical name for Flunec Cream (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 Flunec Cream (Betamethasone) Spray contains 0.643 mg of Flunec Cream (Betamethasone) dipropionate USP (equivalent to 0.5 mg Flunec Cream (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. Flunec Cream (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 Flunec Cream Spray in psoriasis is unknown.
Vasoconstrictor studies performed with Flunec Cream (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 Flunec Cream (Betamethasone) Spray was evaluated in a study randomizing 52 adult subjects with moderate to severe plaque psoriasis. Flunec Cream (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 Flunec Cream (Betamethasone) Spray for 15 days. No subjects (0 out of 24) treated with Flunec Cream (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 Flunec Cream (Betamethasone) dipropionate, betamethasone-17-propionate, and Flunec Cream (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 Flunec Cream (Betamethasone) dipropionate, while the metabolites, betamethasone-17-propionate and Flunec Cream (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) | Flunec Cream (Betamethasone) Spray b.i.d. (15 days) | Flunec Cream (Betamethasone) Spray b.i.d. (29 days) |
Betamethasone-17-propionate | 120 ± 127 | 63.9 ± 52.6 |
Flunec Cream (Betamethasone) | 119 ± 176 | 57.6 ± 55.9 |
Long-term animal studies have not been performed to evaluate the carcinogenic potential of Flunec Cream (Betamethasone) dipropionate.
In a 90-day repeat-dose toxicity study in rats, topical administration of Flunec Cream (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.
Flunec Cream (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 Flunec Cream (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 | |||
Flunec Cream (Betamethasone) Spray b.i.d. (N=182) | Vehicle Spray b.i.d. (N=95) | Flunec Cream (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% |
Flunec Cream 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
Flunec Cream (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 Flunec Cream (Betamethasone) (ser-ne-vo) (betamethasone dipropionate) Spray, 0.05% | |
Important: Flunec Cream (Betamethasone) Spray is for use on the skin only. Do not get Flunec Cream (Betamethasone) Spray near or in your eyes, mouth, or vagina. | |
What is Flunec Cream (Betamethasone) Spray?
It is not known if Flunec Cream (Betamethasone) Spray is safe and effective in children under 18 years of age. Flunec Cream (Betamethasone) Spray is not recommended for use in patients under 18 years of age. | |
Before you use Flunec Cream (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 Flunec Cream (Betamethasone) Spray? See the “Instructions for Use” for detailed information about the right way to apply Flunec Cream (Betamethasone) Spray.
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What are the possible side effects of Flunec Cream (Betamethasone) Spray?
The most common side effects of Flunec Cream (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 Flunec Cream (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 Flunec Cream (Betamethasone) Spray?
Keep Flunec Cream (Betamethasone) Spray and all medicines out of the reach of children. | |
General information about the safe and effective use of Flunec Cream (Betamethasone) Spray. Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. Do not use Flunec Cream (Betamethasone) Spray for a condition for which it was not prescribed. Do not give Flunec Cream (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 Flunec Cream (Betamethasone) Spray that is written for health professionals. | |
What are the ingredients in Flunec Cream (Betamethasone) Spray? Active ingredient: Flunec Cream (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
Flunec Cream (Betamethasone) (ser-ne-vo)
(betamethasone dipropionate)
Spray, 0.05%
Important: Flunec Cream (Betamethasone) Spray is for use on the skin only. Do not get Flunec Cream (Betamethasone) Spray near or in your eyes, mouth, or vagina.
Read this “Instructions for Use” before you start using Flunec Cream (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 Flunec Cream (Betamethasone) Spray bottle.
Figure A
How to apply Flunec Cream (Betamethasone) Spray:
Step 1: Shake the Flunec Cream (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 Flunec Cream (Betamethasone) Spray to the affected area as instructed by your doctor. (See Figure B )
Figure B
Step 3: Spray only enough Flunec Cream (Betamethasone) Spray to cover the affected area, for example, the elbow (See Figure C ). Rub in Flunec Cream (Betamethasone) Spray gently.
Figure C
Repeat Steps 2 and 3 to apply Flunec Cream (Betamethasone) Spray to other affected areas as instructed by your doctor.
Step 4: After applying Flunec Cream (Betamethasone) Spray, place the cap back onto the pump top. (See Figure D )
Figure D
How should I store Flunec Cream (Betamethasone) Spray?
Keep Flunec Cream (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
Flunec Cream (Betamethasone) is a trademark of Promius Pharma, LLC.
Issued: 02/2016
007528
140693
Gentamicin:
F-27078915
NADA #141-177, Approved by FDA.
PRODUCT
INFORMATION
VETERINARY
For Otic Use in Dogs Only
CAUTION Federal law restricts this drug to use by or on the order of a licensed veterinarian.
Keep this and all drugs out of the reach of children.
DESCRIPTION Each gram of Flunec Cream (Gentamicin) Otic Suspension contains Flunec Cream (Gentamicin) sulfate, USP equivalent to 3 mg Flunec Cream (Gentamicin) base; mometasone furoate monohydrate equivalent to 1 mg mometasone; and 10 mg clotrimazole, USP in a mineral oilbased system containing a plasticized hydrocarbon gel.
PHARMACOLOGY
Flunec Cream (Gentamicin): Flunec Cream (Gentamicin) sulfate is an aminoglycoside antibiotic active against a wide variety of gram-negative and grampositive bacteria. In vitro tests have determined that Flunec Cream (Gentamicin) is bactericidal and acts by inhibiting normal protein synthesis in susceptible microorganisms. In clinical trials, Flunec Cream (Gentamicin) was shown to have a range of activity against the following organisms commonly isolated from infected canine ears:
Pseudomonas spp. (including P. aeruginosa), coagulasepositive staphylococci, Enterococcus faecalis, Proteus mirabilis and beta-hemolytic streptococci.
Mometasone: Mometasone furoate monohydrate is a synthetic adrenocorticoid characterized by a novel (2') furoate 17-ester having chlorine at the 9 and 21 positions, which have shown to possess high topical potency.
Systemic absorption of mometasone furoate ointment was found to be minimal (2%) over 1 week when applied topically to dogs with intact skin. In a 6-month dermal toxicity study using 0.1% mometasone ointment on healthy intact skin in dogs, systemic effects typical of corticosteroid therapy were noted.
The extent of percutaneous absorption of topical corticosteroids is determined by many factors including the integrity of the epidermal barrier. Topical corticosteroids can be absorbed from normal, intact skin. Inflammation can increase percutaneous absorption. Once absorbed through the skin, topical corticosteroids are handled through pharmacokinetic pathways similar to systemically administered corticosteroids.
Clotrimazole: Clotrimazole is a broad-spectrum antifungal agent that is used for the treatment of dermal infections caused by various species of dermatophytes and yeast. The primary action of clotrimazole is against dividing and growing organisms.
In vitro, clotrimazole exhibits fungistatic and fungicidal activity against isolates of Trichophyton rubrum, Trichophyton mentagrophytes, Epidermophyton floccosum, Microsporum canis, Candida spp., and Malassezia pachydermatis. Resistance to clotrimazole is very rare among the fungi that cause superficial mycoses. In an induced otitis externa study using dogs infected with Malassezia pachydermatis, 1% clotrimazole in the vehicle formulation was effective both microbiologically and clinically in terms of reduction of exudate, odor, and swelling.
In studies of the mechanism of action, the minimum fungicidal concentration of clotrimazole caused leakage of intracellular phosphorus compounds into the ambient medium with concomitant breakdown of cellular nucleic acids and accelerated potassium efflux. These events began rapidly and extensively after addition of the drug. Clotrimazole is very poorly absorbed following dermal application.
Gentamicin-Mometasone-Clotrimazole: By virtue of its three active ingredients, Flunec Cream (Gentamicin) Otic Suspension has antibacterial, anti-inflammatory, and antifungal activity. In clinical field trials, Flunec Cream (Gentamicin) Otic Suspension was effective in the treatment of otitis externa associated with bacteria and Malassezia pachydermatis. Flunec Cream (Gentamicin) Otic Suspension reduced discomfort, redness, swelling, exudate, and odor.
INDICATIONS Flunec Cream (Gentamicin) Otic Suspension is indicated for the treatment of otitis externa in dogs caused by susceptible strains of yeast (Malassezia pachydermatis) and bacteria (Pseudomonas spp. [including P. aeruginosa], coagulasepositive staphylococci, Enterococcus faecalis, Proteus mirabilis, and beta-hemolytic streptococci).
CONTRAINDICATIONS If hypersensitivity to any of the components occurs, treatment should be discontinued and appropriate therapy instituted. Concomitant use of drugs known to induce ototoxicity should be avoided. Do not use in dogs with known perforation of eardrums.
WARNINGS The use of these components has been associated with deafness or partial hearing loss in a small number of sensitive dogs (eg, geriatric). The hearing deficit is usually temporary. If hearing or vestibular dysfunction is noted during the course of treatment, discontinue use of Flunec Cream (Gentamicin) Otic Suspension immediately and flush the ear canal thoroughly with a nonototoxic solution.
Corticosteroids administered to dogs, rabbits, and rodents during pregnancy have resulted in cleft palate in offspring. Other congenital anomalies including deformed forelegs, phocomelia, and anasarca have been reported in offspring of dogs that received corticosteroids during pregnancy.
Field and experimental data have demonstrated that corticostroids administered orally or parenterally to animals may induce the first stage of parturition if used during the last trimester of pregnancy and may precipitate premature parturition followed by dystocia, fetal death, retained placenta, and metritis.
PRECAUTIONS Before instilling any medication into the ear, examine the external ear canal thoroughly to be certain the tympanic membrane is not ruptured in order to avoid the possibility of transmitting infection to the middle ear as well as damaging the cochlea or vestibular apparatus from prolonged contact.
Administration of recommended doses of Flunec Cream (Gentamicin) Otic Suspension beyond 7 days may result in delayed wound healing. If overgrowth of nonsusceptible bacteria or fungi occurs, treatment should be discontinued and appropriate therapy instituted.
Avoid ingestion. Adverse systemic reactions have been observed following the oral ingestion of some topical corticosteroid preparations. Patients should be closely observed for the usual signs of adrenocorticoid overdosage which include sodium retention, potassium loss, fluid retention, weight gain, polydipsia, and/or polyuria. Prolonged use or overdosage may produce adverse immunosuppressive effects.
Use of corticosteroids, depending on dose, duration, and specific steroid, may result in endogenous steroid production inhibition following drug withdrawal. In patients presently receiving or recently withdrawn from corticosteroid treatments, therapy with a rapidly acting corticosteroid should be considered in especially stressful situations.
TOXICOLOGY Field and safety studies with Flunec Cream (Gentamicin) Otic Suspension have shown a wide safety margin at the recommended dose level in dogs (see PRECAUTIONS/ADVERSE REACTIONS ).
ADVERSE REACTIONS
Flunec Cream (Gentamicin): While aminoglycosides are absorbed poorly from skin, intoxication may occur when aminoglycosides are applied topically for prolonged periods of time to large wounds, burns, or any denuded skin, particularly if there is renal insufficiency. All aminoglycosides have the potential to produce reversible and irreversible vestibular, cochlear, and renal toxicity.
Mometasone: ALP (SAP) and ALT (SGPT) enzyme elevations, weight loss, anorexia, polydipsia, polyuria, neutrophilia, and lymphopenia have occurred following the use of parenteral, high-dose, and/or prolonged or systemic synthetic corticosteroids in dogs. Cushing's syndrome in dogs has been reported in association with prolonged or repeated steroid therapy.
Clotrimazole: The following have been reported occasionally in humans in connection with the use of clotrimazole: erythema, stinging, blistering, peeling, edema, pruritus, urticaria, and general irritation of the skin not present before therapy.
Flunec Cream (Gentamicin) Otic Suspension: In field studies following once daily teatment with Flunec Cream (Gentamicin) Otic Suspension, ataxia, proprioceptive deficits, and increased water consumption were observed in less than 1% of 164 dogs. In a field study following twice-daily treatment with Flunec Cream (Gentamicin) Otic Suspension, inflammation of the pinna and diarrhea were observed in less than 1% of 141 dogs.
DOSAGE AND ADMINISTRATION
The external ear canal should be thoroughly cleaned and dried before treatment. Verify that the eardrum is intact. For dogs weighing less than 30 lbs, instill 4 drops from the 7.5 g, 15 g, and 30 g bottles (2 drops from the 215 g bottle) of Flunec Cream (Gentamicin) Otic Suspension once daily into the ear canal. For dogs weighing 30 lbs or more, instill 8 drops from the 7.5 g, 15 g, and 30 g bottles (4 drops from the 215 g bottle) once daily into the ear canal. Therapy should continue for 7 consecutive days.
HOW SUPPLIED Flunec Cream (Gentamicin) Otic Suspension is available in 7.5 g (NDC 14043-120-75), 15 g (NDC 14043-120-15), 30 g (NDC 14043-120-30), and 215 g (NDC 14043-120-21) plastic bottles.
Store between 2° and 25°C (36° and 77°F). Shake well before use.
U.S. Patent No. 6,127,353.
Distributed by
PATTERSON VETERINARY
137 Barnum Road, Devens, MA 01434
www.pattersonvet.com
Made in Canada.
9/15
85239791
Miconazole:
Flunec Cream (Miconazole) Ointment is indicated for the adjunctive treatment of diaper dermatitis only when complicated by documented candidiasis (microscopic evidence of pseudohyphae and/or budding yeast), in immunocompetent pediatric patients 4 weeks and older. A positive fungal culture for Candida albicansis not adequate evidence of candidal infection since colonization with C. albicans can result in a positive culture. The presence of candidal infection should be established by microscopic evaluation prior to initiating treatment.
Flunec Cream (Miconazole) should be used as part of a treatment regimen that includes measures directed at the underlying diaper dermatitis, including gentle cleansing of the diaper area and frequent diaper changes.
Flunec Cream (Miconazole) should not be used as a substitute for frequent diaper changes. Flunec Cream (Miconazole) should not be used to prevent the occurrence of diaper dermatitis, since preventative use may result in the development of drug resistance.
The safety and efficacy of Flunec Cream (Miconazole) have not been demonstrated in immunocompromised patients, or in infants less than 4 weeks of age (premature or term).
The safety and efficacy of Flunec Cream (Miconazole) have not been evaluated in incontinent adult patients. Flunec Cream (Miconazole) should not be used to prevent the occurrence of diaper dermatitis, such as in an adult institutional setting, since preventative use may result in the development of drug resistance.
Flunec Cream (Miconazole) is not for oral, ophthalmic, or intravaginal use.
Before applying Flunec Cream (Miconazole), gently cleanse the skin with lukewarm water and pat dry with a soft towel. Avoid using any scented soaps, shampoos, or lotions on the diaper area.
Apply Flunec Cream (Miconazole) to the affected area at each diaper change for 7 days. Continue treatment for the full 7 days, even if there is improvement. The safety of Flunec Cream (Miconazole) when used for longer than 7 days is not known. Do not use Flunec Cream (Miconazole) for longer than 7 days. If symptoms have not improved by day 7, see your health care provider.
Gently apply a thin layer of Flunec Cream (Miconazole) to the diaper area with the fingertips. Do not rub Flunec Cream (Miconazole) into the skin as this may cause additional irritation. Thoroughly wash hands after applying Flunec Cream (Miconazole).
White ointment containing 0.25% Flunec Cream (Miconazole) nitrate, 15% zinc oxide, and 81.35% white petrolatum.
None
If irritation occurs or if the disease worsens, discontinue use of the medication, and contact the health care provider.
The safety and efficacy of Flunec Cream (Miconazole) have not been evaluated in incontinent adult patients. Flunec Cream (Miconazole) should not be used to prevent the occurrence of diaper dermatitis, such as in an adult institutional setting, since preventative use may result in the development of drug resistance.
To report SUSPECTED ADVERSE REACTIONS, contact Prestium Pharma, Inc. at 1-866-897-5002 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
Because clinical trials are conducted under widely varying conditions, adverse reaction rate 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.
A total of 835 infants and young children were evaluated in the clinical development program. Of 418 subjects in the Flunec Cream group, 58 (14%) reported one or more adverse events. Of 417 subjects in the zinc oxide/white petrolatum control group, 85 (20%) reported one or more adverse events. Adverse events that occurred at a rate of ≥ 1% for subjects who were treated with Flunec Cream (Miconazole) were approximately the same in type and frequency as for subjects who were treated with zinc oxide/white petrolatum ointment.
The following adverse reactions have been identified during post approval use of Flunec Cream (Miconazole).
GASTROINTESTINAL DISORDERS: vomiting
GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS: burning sensation, condition aggravated, inflammation, pain
INJURY, POISONING AND PROCEDURAL COMPLICATIONS: accidental exposure
SKIN AND SUBCUTANEOUS TISSUE DISORDERS: blister, dermatitis contact, diaper dermatitis, dry skin, erythema, pruritus, rash, skin exfoliation
Because these 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.
Drug-drug interaction studies were not conducted. Women who take a warfarin anticoagulant and use a Flunec Cream (Miconazole) intravaginal cream or suppository may be at risk for developing an increased prothrombin time, international normalized ratio (INR), and bleeding. The potential for this interaction between warfarin and Flunec Cream (Miconazole) is unknown.
There are no adequate and well-controlled studies of Flunec Cream in pregnant women. Therefore, Flunec Cream (Miconazole) should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.
Flunec Cream (Miconazole) nitrate administration has been shown to result in prolonged gestation and decreased numbers of live young in rats and in increased number of resorptions and decreased number of live young in rabbits at oral doses of 100 mg/kg/day and 80 mg/kg/day, which are 28 and 45 times the maximum possible topical exposure of caregivers, respectively, assuming 100% absorption.
Safety and efficacy of Flunec Cream (Miconazole) have not been established in nursing mothers. It is not known if the active components of Flunec Cream (Miconazole) may be present in milk.
Efficacy was not demonstrated in infants less than 4 weeks of age. Safety and efficacy have not been established in very-low-birth-weight infants.
Flunec Cream should not be used to prevent diaper dermatitis.
The safety of Flunec Cream (Miconazole) when used for longer than 7 days is not known. Do not use more than 7 days.
Safety and efficacy in a geriatric population have not been evaluated.
Flunec Cream (Miconazole) contains the synthetic antifungal agent, Flunec Cream (Miconazole) nitrate (0.25%) USP, zinc oxide (15%) USP, and white petrolatum (81.35%) USP.
The chemical name of Flunec Cream (Miconazole) nitrate is 1-[2, 4-dichloro-ß-{(2,4-dichlorobenzyl)oxy} phenethyl] imidazole mononitrate with empirical formula C18H14Cl4N2O-HNO3 and molecular weight of 479.15. The structural formula of Flunec Cream (Miconazole) nitrate is as follows:
The zinc oxide has an empirical formula of ZnO and a molecular weight of 81.39.
The white petrolatum, which is obtained from petroleum and is wholly or nearly decolorized, is a purified mixture of semisolid saturated hydrocarbons having the general chemical formula CnH2n+2. The hydrocarbons consist mainly of branched and unbranched chains. White petrolatum contains butylated hydroxytoluene (BHT) as stabilizer.
Each gram of Flunec Cream (Miconazole) contains 2.5 mg of Flunec Cream (Miconazole) nitrate USP, 150 mg of zinc oxide USP, and 813.5 mg of white petrolatum USP containing butylated hydroxytoluene, trihydroxystearin, and Chemoderm® 1001/B fragrance.1
Flunec Cream (Miconazole) is a smooth, uniform, white ointment.
Structural formula of Flunec Cream (Miconazole) nitrate
The Flunec Cream component of Flunec Cream (Miconazole) is an antifungal agent. The mechanism of action of white petrolatum and zinc oxide for the adjunctive treatment of diaper dermatitis is unknown.
The human pharmacodynamics of Flunec Cream (Miconazole) is unknown.
The topical absorption of Flunec Cream from Flunec Cream (Miconazole) was studied in immunocompetent male and female infants and children (n=17) with diaper dermatitis complicated by documented candidiasis (microscopic evidence of pseudohyphae and/or budding yeast) ranging in age from 1 month to 21 months. After multiple daily applications to the affected area at every diaper change (approximately 5-12 times per day) for 7 days, the plasma concentrations of Flunec Cream (Miconazole) were below the lower limit of quantitation (LOQ) of 0.5 ng/mL in 15 out of 17 (88%) subjects. In the other 2 remaining subjects, the plasma concentrations of Flunec Cream (Miconazole) were 0.57 and 0.58 ng/mL, respectively at a single timepoint (4 hours after the last application) on Day 7.
The Flunec Cream (Miconazole) nitrate component in this product has been shown to have in vitro activity against Candida albicans, an organism that is associated with diaper dermatitis. The activity of Flunec Cream (Miconazole) nitrate against C. albicans is based on the inhibition of the ergosterol biosynthesis in the cell membrane. The accumulation of ergosterol precursors and toxic peroxides results in cytolysis of the cell. In vitro minimal inhibitory concentration (MIC) test results for C. albicans isolates obtained from treatment failures in Clinical Study 1 (see Clinical Studies (14)) does not appear to indicate that resistance to Flunec Cream (Miconazole) nitrate was the reason for treatment failure. The clinical significance of the in vitro activity of Flunec Cream (Miconazole) nitrate against C. albicans in the setting of diaper dermatitis is unclear.
The carcinogenic potential of Flunec Cream (Miconazole) in animals has not been evaluated.
Flunec Cream (Miconazole) nitrate was negative in a bacterial reverse mutation test, a chromosome aberration test in mice, and micronucleus assays in mice and rats.
Flunec Cream (Miconazole) nitrate had no adverse effect on fertility in a study in rats at oral doses of up to 320 mg/kg/day, which is 89 times the maximum possible topical exposure of caregivers, assuming 100% absorption.
Study 1 was a double-blind, multicenter study in which Flunec Cream (Miconazole) was compared to the zinc oxide and white petrolatum combination treatment and included 236 infants and toddlers with diaper dermatitis, complicated by candidiasis as documented by KOH tests that demonstrated psuedohyphae and/or budding yeasts. Study medication was applied at every diaper change for 7 days.
The primary endpoint was “Overall Cure” and required that subjects be both clinically cured (total resolution of all signs and symptoms of infection) and microbiologically cured (eradication of candidiasis). Primary efficacy was assessed 1 week following the end of treatment, at Day 14.
Study results are shown in the following table.
Overall Cure at Day 14 | ||
Flunec Cream (Miconazole) n=112 | Zinc Oxide/White Petrolatum n=124 | |
26 (23%) | 12 (10%) |
Two additional studies provided supportive evidence of the clinical efficacy of Flunec Cream (Miconazole) in infants and toddlers with diaper dermatitis, some of whom cultured positive for C. albicans. However, candidal infection was not documented in the culture-positive subjects, as microscopic testing (e.g. KOH) was not done. Therefore, the positive culture results may have reflected colonization rather than infection.
Flunec Cream is a smooth, uniform, white ointment supplied in an aluminum tube, as follows:
50g (NDC 40076-002-50)
Store at controlled room temperature between 20°C and 25°C (68°F and 77°F); with excursions permitted between 15°C and 30°C (59°F and 86°F).
Keep out of reach of children.
See FDA-Approved Patient Labeling
Patients using Flunec Cream (Miconazole) should be informed about the following information:
Manufactured for:
Prestium Pharma, Inc.
Newtown, PA 18940
Manufactured by:
GlaxoSmithKline
Mississauga, ON, Canada
Made in Canada
© 2013 Delcor Asset Corporation, an affiliate of Prestium Pharma, Inc.
Revised Oct 2013 VSN:3PI
FDA-Approved Patient Labeling
Flunec Cream (Miconazole)® (Vu-sion) Ointment
(0.25% Flunec Cream (Miconazole) nitrate, 15% zinc oxide and 81.35% white petrolatum)
IMPORTANT: For Skin Use Only. Do not use in the mouth, eyes, or vagina.
Read the Patient Information that comes with Flunec Cream (Miconazole) before you use it on your child. This leaflet does not take the place of talking to your health care provider about your child’s medical condition or treatment. If you have any questions or if you are not sure about any of the information on Flunec Cream (Miconazole), ask your health care provider, or pharmacist.
What is Flunec Cream (Miconazole)?
Flunec Cream (Miconazole) is a prescription skin medicine used to treat diaper rash that also has a yeast infection in children who are at least 4 weeks old and who have a normal immune system. Flunec Cream (Miconazole) contains medicines that will help treat the yeast infection and the diaper rash, but you must also change your child’s diapers very often so that your child is not wearing a wet or soiled diaper. Even if you use Flunec Cream (Miconazole), diaper rash will not go away if you do not keep your child’s diaper area clean and dry. You should use water or a very mild cleanser to clean your child’s diaper area. Flunec Cream (Miconazole) is not to be used to prevent diaper rash or to be used for more than 7 days.
Your health care provider will need to do a special test to tell if your child’s diaper rash also has a yeast infection. Do not use Flunec Cream (Miconazole) on your child’s diaper rash unless your health care provider tells you that there is also a yeast infection.
Who should not use Flunec Cream (Miconazole)?
Flunec Cream (Miconazole) is not for treatment of all cases of diaper rash. Flunec Cream (Miconazole) is only for diaper rash that also has a yeast infection. Most cases of diaper rash do not need the yeast medicine that is in Flunec Cream (Miconazole) because most cases of diaper rash do not also have a yeast infection.
Do not use Flunec Cream (Miconazole) on any other children or other family member.
Do not use Flunec Cream (Miconazole) on your child’s diaper rash if they are allergic to anything in it. See the end of this leaflet for a list of ingredients in Flunec Cream (Miconazole).
Do not use on infants less than 4 weeks of age.
Do not use in infants or children who do not have a normal immune system.
How should I use Flunec Cream (Miconazole) on my child?
Flunec Cream (Miconazole) is applied to the skin on your child’s diaper area at each diaper change for 7 days.
Apply Flunec Cream (Miconazole) for the full 7 days even if the diaper rash starts to go away. Call your child’s health care provider if the diaper rash gets worse or does not go away with 7 days of treatment with Flunec Cream (Miconazole). Flunec Cream (Miconazole) should not be used for more than 7 days.
To apply Flunec Cream (Miconazole):
Flunec Cream (Miconazole) is for skin use only.
Call your child’s health care provider or poison control center right away if any Flunec Cream (Miconazole) is swallowed. Call your child’s health care provider if Flunec Cream (Miconazole) gets in the eye.
Keep out of reach of children.
What other steps will help diaper rash go away?
What are the possible side effects of Flunec Cream (Miconazole)?
Flunec Cream (Miconazole) may cause irritation. You should call your child’s health care provider if irritation appears or if the diaper rash gets worse.
How should I store Flunec Cream (Miconazole)?
General information about Flunec Cream (Miconazole)
Medicines are sometimes prescribed for conditions that are not mentioned in patient information leaflets.
Do not use Flunec Cream (Miconazole) for a condition for which it was not prescribed. Do not give Flunec Cream (Miconazole) to other children or family members, even if they have the same symptoms your child has. It may harm them.
This leaflet summarizes the most important information about Flunec Cream (Miconazole). If you would like more information, talk to your child’s health care provider. You can ask your child’s health care provider or pharmacist for information about Flunec Cream (Miconazole) that is written for healthcare professionals.
Side effects may be reported to Prestium Pharma, Inc. at 1-866-897-5002 or the FDA at 1-800-FDA-1088.
What are the ingredients in Flunec Cream (Miconazole)?
Active Ingredients: Flunec Cream (Miconazole) nitrate, zinc oxide, and white petrolatum
Inactive Ingredients: trihydroxystearin, butylated hydroxyltoluene (BHT), and Chemoderm® 1001/B fragrance
This Patient Information leaflet has been approved by the U.S. Food and Drug Administration.
The Patient Information leaflet was last revised: October 2013
Manufactured for:
Prestium Pharma, Inc.
Newtown, PA 18940
Manufactured by:
GlaxoSmithKline
Mississauga, ON, Canada
Made in Canada
© 2013 Delcor Asset Corporation, an affiliate of
Prestium Pharma, Inc.
Revised Oct 2013
VSN:3PIL
Principal Display Panel
NDC 40076-002-50
Flunec Cream (Miconazole)®
(miconazole nitrate 0.25% USP, zinc oxide 15% USP, white petrolatum 81.35% USP)
Ointment
50 grams
Rx only
Principal Display Panel NDC 40076-002-50 Vusion® (miconazole nitrate 0.25% USP, zinc oxide 15% USP, white petrolatum 81.35% USP) Ointment 50 grams Rx only
Depending on the reaction of the Flunec Cream after taken, if you are feeling dizziness, drowsiness or any weakness as a reaction on your body, Then consider Flunec Cream 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 Flunec Cream 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