ADVERSE REACTIONS SECTION.

ADVERSE REACTIONS The most frequent adverse event was burning/itching/stinging at the application site; the incidence and severity of this event were as follows:Incidence and severity of burning/itching/stinging Maximum severityProductTotal incidenceMildModerateSevereBetamethasone valerate foam = 6334 (54%)28 (44%)5 (8%)1 (2%)Betamethasone valerate lotion = 6333 (52%)26 (41%)6 (10%)1 (2%)Placebo Foam = 3224 (75%)13 (41%)7 (22%)4 (12%)Placebo Lotion = 3020 (67%)12 (40%)5 (17%)3 (10%)Other adverse events which were considered to be possibly, probably, or definitely related to betamethasone valerate foam occurred in patient each; these were paresthesia, pruritus, acne, alopecia, and conjunctivitis. The following additional local adverse reactions have been reported with topical corticosteroids, and they may occur more frequently with the use of occlusive dressings. These reactions are listed in an approximately decreasing order of occurrence: irritation; dryness; folliculitis; acneiform eruptions; hypopigmentation; perioral dermatitis; allergic contact dermatitis; secondary infection; skin atrophy; striae; and miliaria.Systemic absorption of topical corticosteroids has produced reversible hypothalamic-pituitary-adrenal (HPA) axis suppression, manifestations of Cushings syndrome, hyperglycemia, and glucosuria in some patients.

CLINICAL PHARMACOLOGY SECTION.

CLINICAL PHARMACOLOGY Like other topical corticosteroids, betamethasone valerate foam has anti-inflammatory, antipruritic, and vasoconstrictive properties. The mechanism of the anti-inflammatory activity of the topical steroids, in general, is unclear. However, corticosteroids are thought to act by the induction of phospholipase A2 inhibitory proteins, collectively called lipocortins. It is postulated that these proteins control the biosynthesis of potent mediators of inflammation such as prostaglandins and leukotrienes by inhibiting the release of their common precursor arachidonic acid. Arachidonic acid is released from membrane phospholipids by phospholipase A2.. Pharmacokinetics Topical corticosteroids can be absorbed from intact healthy skin. The extent of percutaneous absorption of topical corticosteroids is determined by many factors, including the vehicle and the integrity of the epidermal barrier. Occlusion, inflammation and/or other disease processes in the skin may also increase percutaneous absorption.The use of pharmacodynamic endpoints for assessing the systemic exposure of topical corticosteroids is necessary due to the fact that circulating levels are well below the level of detection. Once absorbed through the skin, topical corticosteroids are handled through pharmacokinetic pathways similar to systemically administered corticosteroids. They are metabolized, primarily in the liver, and are then excreted by the kidneys. In addition, some corticosteroids and their metabolites are also excreted in the bile.

GENERAL PRECAUTIONS SECTION.

General Systemic absorption of topical corticosteroids has caused reversible hypothalamic-pituitary-adrenal (HPA) axis suppression with the potential for glucocorticosteroid insufficiency after withdrawal of treatment. Manifestations of Cushings syndrome, hyperglycemia, and glucosuria can also be produced in some patients by systemic absorption of topical corticosteroids while on treatment.Conditions which augment systemic absorption include the application of the more potent steroids, use over large surface areas, prolonged use, and the addition of occlusive dressings.Therefore, patients applying topical steroid to large surface area or to areas under occlusion should be evaluated periodically for evidence of HPA axis suppression. If HPA axis suppression is noted, an attempt should be made to withdraw the drug, to reduce the frequency of application, or to substitute less potent steroid.Recovery of HPA axis function is generally prompt upon discontinuation of topical corticosteroids. Infrequently, signs and symptoms of glucocorticosteroid insufficiency may occur requiring supplemental systemic corticosteroids. For information on systemic supplementation, see prescribing information for those products. Pediatric patients may be more susceptible to systemic toxicity from equivalent doses due to their larger skin surface to body mass ratios. (See PRECAUTIONS-Pediatric Use.)If irritation develops, betamethasone valerate foam should be discontinued and appropriate therapy instituted. Allergic contact dermatitis with corticosteroids is usually diagnosed by observing failure to heal rather than noting clinical exacerbation, as with most topical products not containing corticosteroids. Such an observation should be corroborated with appropriate diagnostic patch testing.In the presence of dermatological infections, the use of an appropriate antifungal or antibacterial agent should be instituted. If favorable response does not occur promptly, use of betamethasone valerate foam should be discontinued until the infection has been adequately controlled.

INFORMATION FOR PATIENTS SECTION.

Information for Patients Patients using topical corticosteroids should receive the following information and instructions:1.This medication is to be used as directed by the physician. It is for external use only. Avoid contact with the eyes.2.This medication should not be used for any disorder other than that for which it was prescribed.3.The treated scalp area should not be bandaged or otherwise covered or wrapped so as to be occlusive unless directed by the physician.4.Patients should report to their physician any signs of local adverse reactions.5.As with other corticosteroids, therapy should be discontinued when control is achieved. If no improvement is seen within weeks, contact the physician.. 1.This medication is to be used as directed by the physician. It is for external use only. Avoid contact with the eyes.. 2.This medication should not be used for any disorder other than that for which it was prescribed.. 3.The treated scalp area should not be bandaged or otherwise covered or wrapped so as to be occlusive unless directed by the physician.. 4.Patients should report to their physician any signs of local adverse reactions.. 5.As with other corticosteroids, therapy should be discontinued when control is achieved. If no improvement is seen within weeks, contact the physician.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL.

PRINCIPAL DISPLAY PANEL 0.12% NDC 0378-8180-50BetamethasoneValerateFoam0.12%Rx only 50 gFOR DERMATOLOGIC USE ONLY.NOT FOR OPHTHALMIC USE.Invert canand thenpress firmlyto dispenseDescription: Betamethasonevalerate foam, 0.12%, contains1.2 mg betamethasone valerate,USP, per gram in thermolabilehydroethanolic foam vehicleconsisting of cetyl alcohol, citricacid, ethanol (60.4%), polysorbate60, potassium citrate, propyleneglycol, purified water, and stearylalcohol pressurized with ahydrocarbon (propane/butane)propellant.Dosage: See package insert for fullprescribing information. Forapplication to the scalp, invert canand dispense small amount ofbetamethasone valerate foam ontoa saucer or other cool surface. (Donot dispense directly onto hands, asfoam will begin to melt immediatelyupon contact with warm skin.) Pickup small amounts of foam withfingers and gently massage intoaffected area until foamdisappears. Repeat until entireaffected scalp area is treated. Applytwice daily, once in the morningand once at night.Warning: FLAMMABLE. AVOIDFIRE, FLAME, OR SMOKINGDURING AND IMMEDIATELYFOLLOWING APPLICATION.Keep away from eyes or othermucous membranes. Keep out ofreach of children.Contents under pressure. Do notpuncture or incinerate container.Do not expose to heat or store attemperatures above 120F (49C).Store at 20 to 25C (68 to 77F).[See USP Controlled RoomTemperature.]DPT:8180:50:1C:R1117459-0317CFC FREEQuestions:Call Mylan PharmaceuticalsInc. at 1-877-446-3679(1-877-4-INFO-RX)Manufactured for: Mylan Pharmaceuticals Inc. Morgantown, WV 26505 U.S.A.Manufactured by: DPT Laboratories, Ltd. San Antonio, TX 78215 U.S.A.Mylan.com. Carton Label Can Inversion. Betamethasone Valerate Foam 0.12% Carton Label.

PATIENT MEDICATION INFORMATION SECTION.

PATIENT INFORMATION Betamethasone Valerate Foam0.12%(bay ta meth sone val er ate)About Betamethasone Valerate FoamYour doctor has prescribed betamethasone valerate foam, 0.12%, for the relief of corticosteroid-responsive skin conditions of the scalp. Betamethasone valerate foam works because its active ingredient is betamethasone valerate, 0.12%. Betamethasone belongs to group of medicines known as topical corticosteroids. These agents are used to reduce the inflammation, redness, swelling, itching, and tenderness associated with dermatologic conditions.Other ingredients in betamethasone valerate foam include cetyl alcohol, citric acid, ethanol, polysorbate 60, potassium citrate, propylene glycol, purified water, and stearyl alcohol. The foam is dispensed from an aluminum can that is pressurized by hydrocarbon propellant (propane and butane).If you answer YES to one or more of the following questions, tell your doctor (or pharmacist) before using this medicine, so you can get advice about what to do. oAre you allergic to any of the ingredients contained in betamethasone valerate foamoAre you pregnant Planning on becoming pregnant while using betamethasone valerate foam Or are you breastfeedingoDo you think you have an infection on your scalpHow to apply betamethasone valerate foamTurn the can upside down and dispense small amount of betamethasone valerate foam onto clean saucer or other cool, clean surface. Do not dispense directly onto hands, as foam will begin to melt immediately upon contact with warm skin. Pick up small amounts of foam with fingers and gently massage into affected area until foam disappears. Repeat until entire affected scalp area is treated. Apply twice daily, once in the morning and once at night. Use sparingly-only enough to cover the affected areas. Gently massage the foam in until it is absorbed and allow the areas to dry naturally.When applying to the scalp, move the hair away so that the foam can be applied directly to each affected area. Wash your hands immediately after applying betamethasone valerate foam, and discard any unused dispensed medication. Do not wash or rinse the treated areas immediately after applying betamethasone valerate foam.oDo not use this medication for any condition other than the one for which it was prescribed.oBetamethasone valerate foam is for external use only.oKeep the foam away from your eyes, as it will sting. If the foam gets into your eyes, rinse well with cold water. If the stinging continues, contact your doctor immediately.WHAT YOU SHOULD KNOW ABOUT BETAMETHASONE VALERATE FOAM:What to do if you miss an applicationIf you forget to apply betamethasone valerate foam at the scheduled time, use it as soon as you remember, and then go back to your regular schedule. If you remember at or about the time of your next daily application, apply that dose and continue with your normal application schedule. If you miss several doses, tell your doctor at your next appointment.About side effectsAs with all medications, there may be some side effects. The most frequent side effects associated with the use of betamethasone valerate foam include mild burning, stinging, or itching at the site of application. These side effects typically disappear shortly after application.Let your doctor know if you notice any of the following:oAny unusual effects that you do not understand.oAffected areas that do not seem to be healing after several weeks of using the foam.Important safety notesoThe treated areas should not be bandaged or covered unless directed by your doctor.oKeep this and all medicines out of the reach of children.oStore the can at controlled room temperature 20 to 25C (68 to 77F) and protect it from direct sunlight, as this is pressurized container.oKeep away from and do not spray near fire, open flame, or direct heat--this product is flammable. Do not smoke while using or holding the can. Keep the can away from all sources of ignition. Do not pierce or burn the can, and never throw the can in fire, even if empty.oWhen you have finished your treatment, dispose of the can safely. completely empty can is recyclable.oDo not use the foam after the expiration date shown on the bottom of the can.oDo not give betamethasone valerate foam to anyone else. Your doctor has prescribed this medicine for your use only.For additional information, call Mylan Pharmaceuticals Inc. at 1-877-446-3679 (1-877-4-INFO-RX).Manufactured for: Mylan Pharmaceuticals Inc. Morgantown, WV 26505 U.S.A.Manufactured by: DPT Laboratories, Ltd. San Antonio, TX 78215Revised: 3/2017PL:DPT:BETA:R1p. oAre you allergic to any of the ingredients contained in betamethasone valerate foam. oAre you pregnant Planning on becoming pregnant while using betamethasone valerate foam Or are you breastfeeding. oDo you think you have an infection on your scalp. oDo not use this medication for any condition other than the one for which it was prescribed.. oBetamethasone valerate foam is for external use only.. oKeep the foam away from your eyes, as it will sting. If the foam gets into your eyes, rinse well with cold water. If the stinging continues, contact your doctor immediately.. oAny unusual effects that you do not understand.. oAffected areas that do not seem to be healing after several weeks of using the foam.. oThe treated areas should not be bandaged or covered unless directed by your doctor.. oKeep this and all medicines out of the reach of children.. oStore the can at controlled room temperature 20 to 25C (68 to 77F) and protect it from direct sunlight, as this is pressurized container.. oKeep away from and do not spray near fire, open flame, or direct heat--this product is flammable. Do not smoke while using or holding the can. Keep the can away from all sources of ignition. Do not pierce or burn the can, and never throw the can in fire, even if empty.. oWhen you have finished your treatment, dispose of the can safely. completely empty can is recyclable.. oDo not use the foam after the expiration date shown on the bottom of the can.. oDo not give betamethasone valerate foam to anyone else. Your doctor has prescribed this medicine for your use only.. Application Figure 1. Application Figure 2. Application Figure 3. Application Figure 4.

PEDIATRIC USE SECTION.

Pediatric Use Safety and effectiveness in pediatric patients have not been established. Because of higher ratio of skin surface area to body mass, pediatric patients are at greater risk than adults of HPA axis suppression and Cushings syndrome when they are treated with topical corticosteroids. They are therefore also at greater risk of adrenal insufficiency during and/or after withdrawal of treatment. Adverse effects including striae have been reported with inappropriate use of topical corticosteroids in infants and children.Hypothalamic-pituitary-adrenal (HPA) axis suppression, Cushings syndrome, linear growth retardation, delayed weight gain, and intracranial hypertension have been reported in children receiving topical corticosteroids. Manifestations of adrenal suppression in children include low plasma cortisol levels and an absence of response to ACTH stimulation. Manifestations of intracranial hypertension include bulging fontanelles, headaches, and bilateral papilledema.Administration of topical corticosteroids to children should be limited to the least amount compatible with an effective therapeutic regimen. Chronic corticosteroid therapy may interfere with the growth and development of children.

PRECAUTIONS SECTION.

PRECAUTIONS General Systemic absorption of topical corticosteroids has caused reversible hypothalamic-pituitary-adrenal (HPA) axis suppression with the potential for glucocorticosteroid insufficiency after withdrawal of treatment. Manifestations of Cushings syndrome, hyperglycemia, and glucosuria can also be produced in some patients by systemic absorption of topical corticosteroids while on treatment.Conditions which augment systemic absorption include the application of the more potent steroids, use over large surface areas, prolonged use, and the addition of occlusive dressings.Therefore, patients applying topical steroid to large surface area or to areas under occlusion should be evaluated periodically for evidence of HPA axis suppression. If HPA axis suppression is noted, an attempt should be made to withdraw the drug, to reduce the frequency of application, or to substitute less potent steroid.Recovery of HPA axis function is generally prompt upon discontinuation of topical corticosteroids. Infrequently, signs and symptoms of glucocorticosteroid insufficiency may occur requiring supplemental systemic corticosteroids. For information on systemic supplementation, see prescribing information for those products. Pediatric patients may be more susceptible to systemic toxicity from equivalent doses due to their larger skin surface to body mass ratios. (See PRECAUTIONS-Pediatric Use.)If irritation develops, betamethasone valerate foam should be discontinued and appropriate therapy instituted. Allergic contact dermatitis with corticosteroids is usually diagnosed by observing failure to heal rather than noting clinical exacerbation, as with most topical products not containing corticosteroids. Such an observation should be corroborated with appropriate diagnostic patch testing.In the presence of dermatological infections, the use of an appropriate antifungal or antibacterial agent should be instituted. If favorable response does not occur promptly, use of betamethasone valerate foam should be discontinued until the infection has been adequately controlled.. Information for Patients Patients using topical corticosteroids should receive the following information and instructions:1.This medication is to be used as directed by the physician. It is for external use only. Avoid contact with the eyes.2.This medication should not be used for any disorder other than that for which it was prescribed.3.The treated scalp area should not be bandaged or otherwise covered or wrapped so as to be occlusive unless directed by the physician.4.Patients should report to their physician any signs of local adverse reactions.5.As with other corticosteroids, therapy should be discontinued when control is achieved. If no improvement is seen within weeks, contact the physician.. 1.This medication is to be used as directed by the physician. It is for external use only. Avoid contact with the eyes.. 2.This medication should not be used for any disorder other than that for which it was prescribed.. 3.The treated scalp area should not be bandaged or otherwise covered or wrapped so as to be occlusive unless directed by the physician.. 4.Patients should report to their physician any signs of local adverse reactions.. 5.As with other corticosteroids, therapy should be discontinued when control is achieved. If no improvement is seen within weeks, contact the physician.. Laboratory Tests The following tests may be helpful in evaluating patients for HPA axis suppression:ACTH stimulation testA.M. plasma cortisol testUrinary free cortisol test. Carcinogenesis, Mutagenesis, and Impairment of Fertility Long-term animal studies have not been performed to evaluate the carcinogenic potential or the effect on fertility of betamethasone valerate.Betamethasone was genotoxic in the in vitro human peripheral blood lymphocyte chromosome aberration assay with metabolic activation and in the in vivo mouse bone marrow micronucleus assay.. Pregnancy Category . Corticosteroids have been shown to be teratogenic in laboratory animals when administered systemically at relatively low dosage levels. Some corticosteroids have been shown to be teratogenic after dermal application in laboratory animals. There are no adequate and well-controlled studies in pregnant women. Therefore, betamethasone valerate foam should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.Drugs of this class should not be used extensively on pregnant patients, in large amounts, or for prolonged periods of time.. 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 breast milk. Because many drugs are excreted in human milk, caution should be exercised when betamethasone valerate foam is administered to nursing woman.. Pediatric Use Safety and effectiveness in pediatric patients have not been established. Because of higher ratio of skin surface area to body mass, pediatric patients are at greater risk than adults of HPA axis suppression and Cushings syndrome when they are treated with topical corticosteroids. They are therefore also at greater risk of adrenal insufficiency during and/or after withdrawal of treatment. Adverse effects including striae have been reported with inappropriate use of topical corticosteroids in infants and children.Hypothalamic-pituitary-adrenal (HPA) axis suppression, Cushings syndrome, linear growth retardation, delayed weight gain, and intracranial hypertension have been reported in children receiving topical corticosteroids. Manifestations of adrenal suppression in children include low plasma cortisol levels and an absence of response to ACTH stimulation. Manifestations of intracranial hypertension include bulging fontanelles, headaches, and bilateral papilledema.Administration of topical corticosteroids to children should be limited to the least amount compatible with an effective therapeutic regimen. Chronic corticosteroid therapy may interfere with the growth and development of children.