Daktar Hydrocortison

What are the side effects you encounter while taking this medicine?
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Daktar Hydrocortison uses

Daktar Hydrocortison consists of Hydrocortisone, Miconazole Nitrate.

Hydrocortisone:


1 INDICATIONS AND USAGE

Daktar Hydrocortison (Hydrocortisone)® (hydrocortisone probutate) Cream, 0.1% is indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses in patients 18 years of age or older.

PANDEL® (hydrocortisone probutate) Cream, 0.1% is a corticosteroid indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses in patients 18 years of age or older.

2 DOSAGE AND ADMINISTRATION

Apply a thin film of Daktar Hydrocortison (Hydrocortisone) to the affected area once or twice a day depending on the severity of the condition. Massage gently until the medication disappears.

Occlusive dressings may be used for the management of refractory lesions of psoriasis and other deep-seated dermatoses, such as localized neurodermatitis (lichen simplex chronicus).

Discontinue Daktar Hydrocortison (Hydrocortisone) when control is achieved. If no improvement is seen within 2 weeks, reassessment of the diagnosis may be necessary.

Do not use Daktar Hydrocortison (Hydrocortisone) with occlusive dressings unless directed by the physician. Do not apply Daktar Hydrocortison (Hydrocortisone) in the diaper area, as diapers or plastic pants may constitute occlusive dressings.

- For topical use.

- Apply a thin film to the affected skin areas once daily or twice a day.

- Discontinue therapy when control is achieved.

- If no improvement is seen within 2 weeks, reassess diagnosis.

- Do not use with occlusive dressings unless directed by a physician.

3 DOSAGE FORMS AND STRENGTHS

Cream, 0.1%. Each gram of Daktar Hydrocortison (Hydrocortisone) contains 1 mg of Daktar Hydrocortison (Hydrocortisone) probutate in a cream base.

Cream, 0.1%.

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4 CONTRAINDICATIONS

None.

None.

5 WARNINGS AND PRECAUTIONS

- Daktar Hydrocortison can produce reversible HPA axis suppression with the potential for glucocorticosteroid insufficiency during or after treatment. (5.1)

- Cushing’s syndrome, hyperglycemia, and unmasking of latent diabetes mellitus can result from systemic absorption of topical corticosteroids. (5.1)

- Use of topical corticosteroids may require periodic evaluation for HPA axis suppression. (5.1)

- High potency corticosteroids, large treatment surface area, prolong use, use of occlusion dressings, altered skin barrier, liver failure and young age may predispose patients to HPA axis suppression. (5.1)

- Modify use if HPA axis suppression develops. (5.1)

- Pediatric patients may be more susceptible to systemic toxicity. (5.1, 8.4)

5.1 Hypothalamic-Pituitary-Adrenal (HPA) Axis Suppression and Other Unwanted Systemic Glucocorticoid Effects

Daktar Hydrocortison (Hydrocortisone) 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.

Use of topical corticosteroids may require periodic evaluation for HPA axis suppression. Evaluation for HPA axis suppression may be done by using the adrenocorticotropic hormone (ACTH) stimulation test.

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. Recovery of HPA axis function is generally prompt and complete upon discontinuation of the drug.

In a trial including 15 evaluable subjects 18 years of age or older with psoriasis or atopic dermatitis affecting more than 20% of body surface area, 1 subject (6.7%) had ACTH stimulation test results suggestive of adrenal suppression after treatment with Daktar Hydrocortison (Hydrocortisone) twice daily for 21 days. Recovery of HPA axis suppression for this subject is unknown [see Clinical Pharmacology ( 12.2 )].

Systemic effects of topical corticosteroids may also manifest as Cushing’s syndrome, hyperglycemia, and unmasking latent diabetes mellitus.

Patients applying a topical steroid to a large surface area or to areas under occlusion should be evaluated periodically for evidence of HPA-axis suppression.

Pediatric patients may be more susceptible to systemic toxicity due to their larger skin surface to body mass ratios [see Use in Specific Populations ( 8.4 )].

5.2 Allergic Contact Dermatitis

Allergic contact dermatitis with corticosteroids is usually diagnosed by observing a failure to heal rather than noting a clinical exacerbation, as observed with most topical products not containing corticosteroids. If irritation develops, discontinue Daktar Hydrocortison (Hydrocortisone) and institute appropriate therapy.

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6 ADVERSE REACTIONS

- Most frequent adverse reactions include burning, stinging, rash, papulovesicular rash, redness, itching, moderate paresthesia, and contact dermatitis.

To report SUSPECTED ADVERSE REACTIONS, contact PharmaDerm®, A division of Fougera Pharmaceuticals Inc. at 1-800-645-9833 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

6.1 Clinical Trials Experience

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.

The most frequent adverse reactions reported for Daktar Hydrocortison (Hydrocortisone) during clinical trials were application site reactions, including burning in 4, stinging in 2, and moderate paresthesia in 1 out of 226 subjects.

6.2 Postmarketing Experience

The following adverse reactions have been identified during postapproval use of Daktar Hydrocortison (Hydrocortisone) because these reactions were 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.

These adverse reactions are as follows:

Skin and Subcutaneous Tissue Disorders: rash, papulovesicular rash

Application Site Reactions: dryness, erythema, pruritus, allergic contact dermatitis.

The following local adverse reactions are reported with topical corticosteroids, and they may occur more frequently with the use of occlusive dressings. These reactions are listed in an approximate decreasing order of occurrence: itching, irritation, dryness, folliculitis, hypertrichosis, acneiform eruptions, hypopigmentation, perioral dermatitis, allergic contact dermatitis, secondary infections, skin atrophy, striae, and miliaria.

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8 USE IN SPECIFIC POPULATIONS

8.1 Pregnancy

Risk Summary

There is no clinical information on Daktar Hydrocortison use in pregnant women to inform any drug-associated risk for major birth defects and miscarriage. In animal reproduction studies, Daktar Hydrocortison (Hydrocortisone) probutate given by the subcutaneous route during the period of organogenesis was teratogenic at doses equal to or greater than 1 mg/kg/day in rats or 0.1 mg/kg/day in rabbits (12 times and 2 times the human topical dose, respectively) .

The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively.

Data

Animal Data

Effects on embryo-fetal development were evaluated in rats and rabbits following subcutaneous administration of Daktar Hydrocortison (Hydrocortisone) probutate during the period of organogenesis. Daktar Hydrocortison (Hydrocortisone) probutate was teratogenic in rats when given during the period of organogenesis at subcutaneous doses equal to or greater than 1 mg/kg/day (12 times the human average topical dose of Daktar Hydrocortison (Hydrocortisone) assuming 3% absorption and an application of 30 g/day on a 70 kg individual). Abnormalities included delayed ossification of the caudal vertebrae and other skeletal variations, cleft palate, umbilical hernia, edema, and exencephalia.

In rabbits, Daktar Hydrocortison (Hydrocortisone) probutate given by the subcutaneous route was teratogenic at doses equal to or greater than 0.1 mg/kg/day (2 times the human average topical dose of Daktar Hydrocortison (Hydrocortisone) assuming 3% absorption and an application of 30 g/day on a 70 kg individual). Fetal weight and survival were affected. Delayed ossification and increased incidences of malformations (skeletal abnormalities and cleft palate) were also noted.

No adverse effects were seen in rats following subcutaneous administration of up to 1 mg/kg/day of Daktar Hydrocortison (Hydrocortisone) probutate during the perinatal and postnatal period (12 times the human average topical dose of Daktar Hydrocortison (Hydrocortisone) assuming 3% absorption and an application of 30 g/day on a 70 kg individual).

8.2 Lactation

Risk Summary

There is no information on the presence of Daktar Hydrocortison (Hydrocortisone) probutate in breast milk, or on its effects on the breastfed infant or on milk production. It is not known whether topical administration of Daktar Hydrocortison (Hydrocortisone) could result in sufficient systemic absorption to produce detectable quantities in human milk. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for Daktar Hydrocortison (Hydrocortisone) and any potential adverse effects on the breastfed infant from Daktar Hydrocortison (Hydrocortisone) or from the underlying maternal condition.

Clinical Considerations

To minimize potential exposure to the breastfed infant via breast milk, use Daktar Hydrocortison (Hydrocortisone) on the smallest area of skin and for the shortest duration possible while breastfeeding.

8.4 Pediatric Use

Safety and effectiveness in pediatric patients have not been established. Because of a higher ratio of skin surface area to body mass, pediatric patients are at a greater risk than adults of HPA axis suppression and Cushing’s syndrome when they are treated with topical corticosteroids. They are therefore also at a 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, Cushing’s 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.

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11 DESCRIPTION

Daktar Hydrocortison (Hydrocortisone)(hydrocortisone probutate) Cream, 0.1% contains Daktar Hydrocortison (Hydrocortisone) probutate, a synthetic corticosteroid. The topical corticosteroids constitute a class of primarily synthetic steroids used as anti-inflammatory and anti-pruritic agents.

Daktar Hydrocortison (Hydrocortisone) probutate is a tasteless and odorless white crystalline powder practically insoluble in hexane or water, slightly soluble in ether, and very soluble in dichloromethane, methanol and acetone. Chemically, it is 11β,17,21-trihydroxypregn-4-ene-3,20-dione 17-butyrate 21-propionate. The structural formula is:

Molecular Formula: C28H40O7

Molecular Weight: 488.62

Each gram of Daktar Hydrocortison (Hydrocortisone) (hydrocortisone probutate) Cream, 0.1% contains: 1 mg of Daktar Hydrocortison (Hydrocortisone) probutate in a cream base of propylene glycol, white petrolatum, light mineral oil, stearyl alcohol, polysorbate 60, sorbitan monostearate, glyceryl monostearate, PEG-20 stearate, glyceryl stearate SE, methylparaben, butylparaben, citric acid, sodium citrate anhydrous, and purified water.

Structural Formula

12 CLINICAL PHARMACOLOGY

12.1 Mechanism of Action

Corticosteroids play a role in cellular signaling, immune function, inflammation, and protein regulation; however, the precise mechanism of action in corticosteroid responsive dermatoses is unknown

12.2 Pharmacodynamics

Vasoconstrictor Assay

Studies performed with Daktar Hydrocortison indicate that it is in the medium range of potency as demonstrated in vasoconstrictor trials in healthy subjects when compared with other topical corticosteroids. However, similar blanching scores do not necessarily imply therapeutic equivalence.

Hypothalamic-Pituitary-Adrenal (HPA) Axis Suppression

In an open label HPA axis suppression trial, 19 adult subjects (ages 23 to 82 years) with atopic dermatitis or plaque psoriasis covering greater than 20% Body Surface Area (BSA) were treated with Daktar Hydrocortison (Hydrocortisone) twice daily for 21 days and were assessed for HPA axis suppression. At baseline, the mean disease BSA involvement was 36%. The criterion for HPA axis suppression was a serum cortisol level of less than or equal to 18 micrograms per deciliter at 30-minutes after cosyntropin stimulation. Of these subjects, 15 were considered evaluable with respect to their adrenal axis function post-treatment. One of the evaluable subjects (6.7%) showed laboratory evidence of suppression on Day 22. This subject had psoriasis covering 48% of BSA at baseline and was reported to have received 98% of the twice-daily applications of Daktar Hydrocortison (Hydrocortisone) over the 21 day treatment period. It is not known if this subject had recovery of adrenal function because follow-up testing was not performed.

12.3 Pharmacokinetics

The extent of percutaneous absorption of topical corticosteroids is determined by many factors, including the vehicle and the integrity of the epidermal barrier. Use of occlusive dressings with Daktar Hydrocortison (Hydrocortisone) for up to 24 hours has not been shown to increase penetration; however, occlusion of Daktar Hydrocortison (Hydrocortisone) for 96 hours does markedly enhance penetration. Topical corticosteroids can be absorbed from normal intact skin. Inflammation and/or other disease processes in the skin increase percutaneous absorption.

13 NONCLINICAL TOXICOLOGY

13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility

No long-term studies in animals have been performed to evaluate the carcinogenic potential of Daktar Hydrocortison (Hydrocortisone) probutate.

Daktar Hydrocortison (Hydrocortisone) probutate revealed no evidence of mutagenic or clastogenic potential based on the results of an in vitro genotoxicity test (Ames assay) and an in vivo genotoxicity test (mouse micronucleus assay).

Effects on fertility and early embryonic development were evaluated in rats following subcutaneous administration of up to 0.4 mg/kg/day Daktar Hydrocortison (Hydrocortisone) probutate (5 times the human average topical dose of Daktar Hydrocortison (Hydrocortisone) assuming 3% absorption and an application of 30 g/day on a 70 kg individual) prior to and during mating and through early pregnancy. No treatment related effects on fertility or mating parameters were noted in this study.

16 HOW SUPPLIED/STORAGE AND HANDLING

Daktar Hydrocortison (Hydrocortisone), a white to off-white opaque cream is supplied as follows:

45 g tubes NDC 10337-153-46

80 g tubes NDC 10337-153-80

Store at 20° to 25°C (68° to 77°F).

17 PATIENT COUNSELING INFORMATION

Advise the patient and/or caregiver to read the FDA-approved patient labeling (Patient Information).

Inform patients and/or caregivers of the following:

  • Discontinue therapy when control is achieved unless directed otherwise by the physician.
  • If no improvement is seen within two weeks, contact the physician.
  • Avoid contact with the eyes.
  • Do not use with occlusive dressing unless directed by the physician.
  • Report any signs or symptoms of local or systemic adverse reactions to the physician.
  • Do not treat diaper dermatitis. Do not apply Daktar Hydrocortison (Hydrocortisone) in the diaper area as diapers or plastic pants may constitute occlusive dressings.
  • Do not use on the face, underarms, or groin areas unless directed by the physician.
  • Advise a woman to use Daktar Hydrocortison (Hydrocortisone) on the smallest area of skin and for the shortest duration possible while breastfeeding.

Manufactured by:

PharmaDerm®

A division of Fougera

PHARMACEUTICALS INC.

Melville, New York 11747 www.pharmaderm.com


PATIENT INFORMATION

Daktar Hydrocortison (Hydrocortisone)® (pan-del)

(hydrocortisone probutate)

cream


Important: Daktar Hydrocortison (Hydrocortisone) is for use on skin only (topical). Avoid using Daktar Hydrocortison (Hydrocortisone) near or around your eyes.


What is Daktar Hydrocortison (Hydrocortisone)?

Daktar Hydrocortison (Hydrocortisone) is a prescription corticosteroid medicine used on the skin (topical) for the relief of inflammation and itching caused by certain skin conditions in people 18 years of age or older.

It is not known if Daktar Hydrocortison (Hydrocortisone) is safe and effective in children.


Before using Daktar Hydrocortison (Hydrocortisone) tell your healthcare provider about all of your medical conditions, including if you:

- have adrenal gland problems

- have liver problems

- have diabetes

- have thinning skin (atrophy) at the site to be treated.

- are pregnant or plan to become pregnant. It is not known if Daktar Hydrocortison (Hydrocortisone) will harm your unborn baby.

- are breastfeeding or plan to breastfeed. It is not known if Daktar Hydrocortison (Hydrocortisone) can pass into your breast milk and harm your baby.

  • o If you breastfeed during treatment with Daktar Hydrocortison (Hydrocortisone), clean the treated area of skin on and near your breast, and your nipple before breastfeeding. This will help prevent contact of Daktar Hydrocortison (Hydrocortisone) with your baby’s skin.
  • o You should use Daktar Hydrocortison (Hydrocortisone) on the smallest area of skin and for the shortest time possible while breastfeeding.

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.


How should I use Daktar Hydrocortison (Hydrocortisone)?

- Use Daktar Hydrocortison (Hydrocortisone) exactly as your healthcare provider tells you to use it.

- Apply a thin film to the affected skin area. Gently rub Daktar Hydrocortison (Hydrocortisone) into your skin until it disappears.

- Tell your healthcare provider if your symptoms do not improve after 2 weeks of treatment.

- Do not bandage, cover, or wrap the treated area unless your healthcare provider tells you to.

- Do not apply Daktar Hydrocortison (Hydrocortisone) in the diaper area or use with plastic pants.

- Do not use Daktar Hydrocortison (Hydrocortisone) on your face, underarms (armpits) or groin areas unless your healthcare provider tells you to.

- Wash your hands after applying Daktar Hydrocortison (Hydrocortisone), unless your hands are being treated.


What are possible side effects with Daktar Hydrocortison (Hydrocortisone)?

Daktar Hydrocortison (Hydrocortisone) may cause serious side effects, including:

- Daktar Hydrocortison (Hydrocortisone) can pass through your skin and may cause adrenal gland problems. This is more likely to happen if you use Daktar Hydrocortison (Hydrocortisone) for too long, use it over a large treatment area, use it with other topical medicines that contain corticosteroids, cover the treated area, or have liver failure. Your healthcare provider may do blood tests to check your adrenal gland function during and after treatment with Daktar Hydrocortison (Hydrocortisone).

- Skin problems, including skin reactions or thinning of your skin (atrophy), skin infections, and allergic reactions (allergic contact dermatitis) at the treatment site. Tell your healthcare provider if you get any skinreactions such as pain, tenderness, swelling, or healing problems.

The most common side effects of Daktar Hydrocortison (Hydrocortisone) include burning and stinging and moderate tingling or prickling feeling.

These are not all the possible side effects with Daktar Hydrocortison (Hydrocortisone). 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 Daktar Hydrocortison (Hydrocortisone)?

- Store Daktar Hydrocortison (Hydrocortisone) between 68°F to 77°F (20°C to 25°C).

Keep Daktar Hydrocortison (Hydrocortisone) and all medicines out of the reach of children.


General information about the safe and effective use of Daktar Hydrocortison (Hydrocortisone).

Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. Do not use Daktar Hydrocortison (Hydrocortisone) for a condition for which it was not prescribed. Do not give Daktar Hydrocortison (Hydrocortisone) to other people, even if they have the same symptoms you have. It may harm them. You can ask your pharmacist or healthcare provider for information about Daktar Hydrocortison (Hydrocortisone) that is written for health professionals.


What are the ingredients in Daktar Hydrocortison (Hydrocortisone)?

Active ingredient: Daktar Hydrocortison (Hydrocortisone) probutate

Inactive ingredients: propylene glycol, white petrolatum, light mineral oil, stearyl alcohol, polysorbate 60, sorbitan monostearate, glyceryl monostearate, PEG-20 stearate, glyceryl stearate SE, methylparaben, butylparaben, citric acid, sodium citrate anhydrous, and purified water.

Manufactured by:PharmaDerm® A division of Fougera PHARMACEUTICALS INC. Melville, New York 11747

For more information, go to www.pharmaderm.com or call 1-800-645-9833.

  • This Patient Information has been approved by the U.S. Food and Drug Administration. Issued: 01/2017

PharmaDerm®

NDC 10337-153-80

Daktar Hydrocortison (Hydrocortisone)®

(hydrocortisone probutate) Cream, 0.1%

FOR DERMATOLOGIC USE ONLY.

NOT FOR OPHTHALMIC USE.

Rx only

80 g

carton

Miconazole Nitrate:


1 INDICATIONS AND USAGE

  • Daktar Hydrocortison Ointment is indicated for adjunctive treatment of diaper dermatitis when complicated by documented candidiasis (microscopic evidence of pseudohyphae and /or budding yeast) in immunocompetent pediatric patients 4 weeks and older. (1)
  • Daktar Hydrocortison (Miconazole Nitrate) Ointment should not be used as a substitute for frequent diaper changes. (1)
  • Daktar Hydrocortison (Miconazole Nitrate) Ointment should not be used to prevent the occurrence of diaper dermatitis, since preventative use may result in the development of drug resistance. (1)

1.1 Indication

Daktar Hydrocortison (Miconazole Nitrate) 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.

Daktar Hydrocortison (Miconazole Nitrate) 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.

Daktar Hydrocortison (Miconazole Nitrate) should not be used as a substitute for frequent diaper changes. Daktar Hydrocortison (Miconazole Nitrate) should not be used to prevent the occurrence of diaper dermatitis, since preventative use may result in the development of drug resistance.

1.2 Limitations of Use

The safety and efficacy of Daktar Hydrocortison (Miconazole Nitrate) have not been demonstrated in immunocompromised patients, or in infants less than 4 weeks of age (premature or term).

The safety and efficacy of Daktar Hydrocortison (Miconazole Nitrate) have not been evaluated in incontinent adult patients. Daktar Hydrocortison (Miconazole Nitrate) 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.

2 DOSAGE AND ADMINISTRATION

Daktar Hydrocortison (Miconazole Nitrate) is not for oral, ophthalmic, or intravaginal use.

Before applying Daktar Hydrocortison (Miconazole Nitrate), 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 Daktar Hydrocortison (Miconazole Nitrate) 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 Daktar Hydrocortison (Miconazole Nitrate) when used for longer than 7 days is not known. Do not use Daktar Hydrocortison (Miconazole Nitrate) for longer than 7 days. If symptoms have not improved by day 7, see your health care provider.

Gently apply a thin layer of Daktar Hydrocortison (Miconazole Nitrate) to the diaper area with the fingertips. Do not rub Daktar Hydrocortison (Miconazole Nitrate) into the skin as this may cause additional irritation. Thoroughly wash hands after applying Daktar Hydrocortison (Miconazole Nitrate).

  • Daktar Hydrocortison (Miconazole Nitrate) Ointment is for topical use only. Daktar Hydrocortison (Miconazole Nitrate) Ointment is not for oral, ophthalmic, or intravaginal use. (2)
  • Daktar Hydrocortison (Miconazole Nitrate) Ointment should be applied as a thin layer to the affected area at each diaper change for 7 days. (2)
  • Daktar Hydrocortison (Miconazole Nitrate) Ointment should be used as part of a treatment regimen that includes gentle cleansing of the diaper area and frequent diaper changes. (2)

3 DOSAGE FORMS AND STRENGTHS

White ointment containing 0.25% Daktar Hydrocortison (Miconazole Nitrate) nitrate, 15% zinc oxide, and 81.35% white petrolatum.

  • Ointment with 0.25% Daktar Hydrocortison (Miconazole Nitrate) nitrate, 15% zinc oxide, and 81.35% white petrolatum. (3)

4 CONTRAINDICATIONS

None

  • None

5 WARNINGS AND PRECAUTIONS

If irritation occurs or if the disease worsens, discontinue use of the medication, and contact the health care provider.

The safety and efficacy of Daktar Hydrocortison (Miconazole Nitrate) have not been evaluated in incontinent adult patients. Daktar Hydrocortison (Miconazole Nitrate) 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.

  • If irritation occurs or if the disease worsens, discontinue use of the medication, and contact the health care provider. (5)

6 ADVERSE REACTIONS

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.

6.1 Clinical Trials Experience

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 Daktar Hydrocortison 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 Daktar Hydrocortison (Miconazole Nitrate) were approximately the same in type and frequency as for subjects who were treated with zinc oxide/white petrolatum ointment.

6.2 Post-marketing Experience

The following adverse reactions have been identified during post approval use of Daktar Hydrocortison (Miconazole Nitrate).

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.

7 DRUG INTERACTIONS

Drug-drug interaction studies were not conducted. Women who take a warfarin anticoagulant and use a Daktar Hydrocortison (Miconazole Nitrate) 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 Daktar Hydrocortison (Miconazole Nitrate) is unknown.

8 USE IN SPECIFIC POPULATIONS

8.1 Pregnancy

Pregnancy Category C

There are no adequate and well-controlled studies of Daktar Hydrocortison in pregnant women. Therefore, Daktar Hydrocortison (Miconazole Nitrate) should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

Daktar Hydrocortison (Miconazole Nitrate) 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.

8.3 Nursing Mothers

Safety and efficacy of Daktar Hydrocortison (Miconazole Nitrate) have not been established in nursing mothers. It is not known if the active components of Daktar Hydrocortison (Miconazole Nitrate) may be present in milk.

8.4 Pediatric Use

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.

Daktar Hydrocortison should not be used to prevent diaper dermatitis.

The safety of Daktar Hydrocortison (Miconazole Nitrate) when used for longer than 7 days is not known. Do not use more than 7 days.

8.5 Geriatric Use

Safety and efficacy in a geriatric population have not been evaluated.

11 DESCRIPTION

Daktar Hydrocortison (Miconazole Nitrate) contains the synthetic antifungal agent, Daktar Hydrocortison (Miconazole Nitrate) nitrate (0.25%) USP, zinc oxide (15%) USP, and white petrolatum (81.35%) USP.

The chemical name of Daktar Hydrocortison (Miconazole Nitrate) 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 Daktar Hydrocortison (Miconazole Nitrate) 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 Daktar Hydrocortison (Miconazole Nitrate) contains 2.5 mg of Daktar Hydrocortison (Miconazole Nitrate) 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

Daktar Hydrocortison (Miconazole Nitrate) is a smooth, uniform, white ointment.

Structural formula of Daktar Hydrocortison (Miconazole Nitrate) nitrate

12 CLINICAL PHARMACOLOGY

12.1 Mechanism of Action

The Daktar Hydrocortison component of Daktar Hydrocortison (Miconazole Nitrate) is an antifungal agent. The mechanism of action of white petrolatum and zinc oxide for the adjunctive treatment of diaper dermatitis is unknown.

12.2 Pharmacodynamics

The human pharmacodynamics of Daktar Hydrocortison (Miconazole Nitrate) is unknown.

12.3 Pharmacokinetics

The topical absorption of Daktar Hydrocortison from Daktar Hydrocortison (Miconazole Nitrate) 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 Daktar Hydrocortison (Miconazole Nitrate) 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 Daktar Hydrocortison (Miconazole Nitrate) were 0.57 and 0.58 ng/mL, respectively at a single timepoint (4 hours after the last application) on Day 7.

12.4 Microbiology

The Daktar Hydrocortison (Miconazole Nitrate) 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 Daktar Hydrocortison (Miconazole Nitrate) 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 Daktar Hydrocortison (Miconazole Nitrate) nitrate was the reason for treatment failure. The clinical significance of the in vitro activity of Daktar Hydrocortison (Miconazole Nitrate) nitrate against C. albicans in the setting of diaper dermatitis is unclear.

13 NONCLINICAL TOXICOLOGY

13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility

The carcinogenic potential of Daktar Hydrocortison (Miconazole Nitrate) in animals has not been evaluated.

Daktar Hydrocortison (Miconazole Nitrate) nitrate was negative in a bacterial reverse mutation test, a chromosome aberration test in mice, and micronucleus assays in mice and rats.

Daktar Hydrocortison (Miconazole Nitrate) 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.

14 CLINICAL STUDIES

Study 1 was a double-blind, multicenter study in which Daktar Hydrocortison (Miconazole Nitrate) 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
Daktar Hydrocortison (Miconazole Nitrate)

n=112

Zinc Oxide/White Petrolatum

n=124

26 (23%) 12 (10%)

Two additional studies provided supportive evidence of the clinical efficacy of Daktar Hydrocortison (Miconazole Nitrate) 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.

16 HOW SUPPLIED/STORAGE AND HANDLING

16.1 How Supplied

Daktar Hydrocortison is a smooth, uniform, white ointment supplied in an aluminum tube, as follows:

50g (NDC 40076-002-50)

16.2 Storage Conditions

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.

17 PATIENT COUNSELING INFORMATION

See FDA-Approved Patient Labeling

Patients using Daktar Hydrocortison (Miconazole Nitrate) should be informed about the following information:

  • Daktar Hydrocortison (Miconazole Nitrate) is to be used only for diaper dermatitis that is complicated by documented candidiasis (i.e. documented by microscopic testing).
  • Daktar Hydrocortison (Miconazole Nitrate) should not be used as a substitute for frequent diaper changes.
  • Daktar Hydrocortison (Miconazole Nitrate) should not be used to prevent diaper dermatitis.
  • Daktar Hydrocortison (Miconazole Nitrate) should not be used long term.
  • Daktar Hydrocortison (Miconazole Nitrate) should be used only as directed by the health care provider.
  • Daktar Hydrocortison (Miconazole Nitrate) is for external use only. It is not for oral, ophthalmic, or intravaginal use.
  • Gently cleanse the diaper area with lukewarm water or a very mild soap and pat the area dry with a soft towel before applying Daktar Hydrocortison (Miconazole Nitrate).
  • Gently apply Daktar Hydrocortison (Miconazole Nitrate) to the diaper area with the fingertips after each diaper change. Do not rub Daktar Hydrocortison (Miconazole Nitrate) into the skin as this may cause additional irritation.
  • Thoroughly wash hands after applying Daktar Hydrocortison (Miconazole Nitrate).
  • Treatment should be continued for 7 days, even if there is improvement. Do not use Daktar Hydrocortison (Miconazole Nitrate) for longer than 7 days. If symptoms have not improved by day 7, see your health care provider.
  • Daktar Hydrocortison (Miconazole Nitrate) should not be used on children for whom it is not prescribed.

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

Daktar Hydrocortison (Miconazole Nitrate)® (Vu-sion) Ointment

(0.25% Daktar Hydrocortison (Miconazole Nitrate) 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 Daktar Hydrocortison (Miconazole Nitrate) 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 Daktar Hydrocortison (Miconazole Nitrate), ask your health care provider, or pharmacist.

What is Daktar Hydrocortison (Miconazole Nitrate)?

Daktar Hydrocortison (Miconazole Nitrate) 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. Daktar Hydrocortison (Miconazole Nitrate) 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 Daktar Hydrocortison (Miconazole Nitrate), 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. Daktar Hydrocortison (Miconazole Nitrate) 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 Daktar Hydrocortison (Miconazole Nitrate) on your child’s diaper rash unless your health care provider tells you that there is also a yeast infection.

Who should not use Daktar Hydrocortison (Miconazole Nitrate)?

Daktar Hydrocortison (Miconazole Nitrate) is not for treatment of all cases of diaper rash. Daktar Hydrocortison (Miconazole Nitrate) 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 Daktar Hydrocortison (Miconazole Nitrate) because most cases of diaper rash do not also have a yeast infection.

Do not use Daktar Hydrocortison (Miconazole Nitrate) on any other children or other family member.

Do not use Daktar Hydrocortison (Miconazole Nitrate) 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 Daktar Hydrocortison (Miconazole Nitrate).

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 Daktar Hydrocortison (Miconazole Nitrate) on my child?

Daktar Hydrocortison (Miconazole Nitrate) is applied to the skin on your child’s diaper area at each diaper change for 7 days.

Apply Daktar Hydrocortison (Miconazole Nitrate) 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 Daktar Hydrocortison (Miconazole Nitrate). Daktar Hydrocortison (Miconazole Nitrate) should not be used for more than 7 days.

To apply Daktar Hydrocortison (Miconazole Nitrate):

  • Gently, clean the skin on your child’s diaper area with warm ( not hot ) water. You may also use a very mild soap. Pat the area dry with a soft towel.
  • Use your fingertips and gently apply a thin layer of Daktar Hydrocortison (Miconazole Nitrate) to your child’s diaper area at each diaper change. Do not rub Daktar Hydrocortison (Miconazole Nitrate) into your child’s skin. Rubbing the skin can cause more irritation.
  • Wash your hands after applying Daktar Hydrocortison (Miconazole Nitrate) on your child.

Daktar Hydrocortison (Miconazole Nitrate) is for skin use only.

Call your child’s health care provider or poison control center right away if any Daktar Hydrocortison (Miconazole Nitrate) is swallowed. Call your child’s health care provider if Daktar Hydrocortison (Miconazole Nitrate) gets in the eye.

Keep out of reach of children.

What other steps will help diaper rash go away?

  • Check your child’s diaper often. Change the diaper at the first sign of wetness.
  • Clean your child’s diaper area after each diaper change. Gently wipe the diaper area from the front to back using warm ( not hot )water. You may also use a mild soap. Rinse the diaper area well. Pat dry with a soft towel.
  • Keep the diaper area open to air when possible.
  • Even if you use Daktar Hydrocortison (Miconazole Nitrate), diaper rash will not go away if you do not keep your child’s diaper area clean and dry.

What are the possible side effects of Daktar Hydrocortison (Miconazole Nitrate)?

Daktar Hydrocortison (Miconazole Nitrate) 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 Daktar Hydrocortison (Miconazole Nitrate)?

  • Keep Daktar Hydrocortison (Miconazole Nitrate) out of the reach of children to avoid the risk of accidental ingestion.
  • Store Daktar Hydrocortison (Miconazole Nitrate) at room temperature between 68°F to 77°F (20°C to 25°C).

General information about Daktar Hydrocortison (Miconazole Nitrate)

Medicines are sometimes prescribed for conditions that are not mentioned in patient information leaflets.

Do not use Daktar Hydrocortison (Miconazole Nitrate) for a condition for which it was not prescribed. Do not give Daktar Hydrocortison (Miconazole Nitrate) 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 Daktar Hydrocortison (Miconazole Nitrate). 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 Daktar Hydrocortison (Miconazole Nitrate) 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 Daktar Hydrocortison (Miconazole Nitrate)?

Active Ingredients: Daktar Hydrocortison (Miconazole Nitrate) 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

Daktar Hydrocortison (Miconazole Nitrate)®

(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

Daktar Hydrocortison pharmaceutical active ingredients containing related brand and generic drugs:

Active ingredient is the part of the drug or medicine which is biologically active. This portion of the drug is responsible for the main action of the drug which is intended to cure or reduce the symptom or disease. The other portions of the drug which are inactive are called excipients; there role is to act as vehicle or binder. In contrast to active ingredient, the inactive ingredient's role is not significant in the cure or treatment of the disease. There can be one or more active ingredients in a drug.


Daktar Hydrocortison available forms, composition, doses:

Form of the medicine is the form in which the medicine is marketed in the market, for example, a medicine X can be in the form of capsule or the form of chewable tablet or the form of tablet. Sometimes same medicine can be available as injection form. Each medicine cannot be in all forms but can be marketed in 1, 2, or 3 forms which the pharmaceutical company decided based on various background research results.
Composition is the list of ingredients which combinedly form a medicine. Both active ingredients and inactive ingredients form the composition. The active ingredient gives the desired therapeutic effect whereas the inactive ingredient helps in making the medicine stable.
Doses are various strengths of the medicine like 10mg, 20mg, 30mg and so on. Each medicine comes in various doses which is decided by the manufacturer, that is, pharmaceutical company. The dose is decided on the severity of the symptom or disease.


Daktar Hydrocortison destination | category:

Destination is defined as the organism to which the drug or medicine is targeted. For most of the drugs what we discuss, human is the drug destination.
Drug category can be defined as major classification of the drug. For example, an antihistaminic or an antipyretic or anti anginal or pain killer, anti-inflammatory or so.


Daktar Hydrocortison Anatomical Therapeutic Chemical codes:

A medicine is classified depending on the organ or system it acts [Anatomical], based on what result it gives on what disease, symptom [Therapeutical], based on chemical composition [Chemical]. It is called as ATC code. The code is based on Active ingredients of the medicine. A medicine can have different codes as sometimes it acts on different organs for different indications. Same way, different brands with same active ingredients and same indications can have same ATC code.


Daktar Hydrocortison pharmaceutical companies:

Pharmaceutical companies are drug manufacturing companies that help in complete development of the drug from the background research to formation, clinical trials, release of the drug into the market and marketing of the drug.
Researchers are the persons who are responsible for the scientific research and is responsible for all the background clinical trials that resulted in the development of the drug.


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References

  1. Dailymed."HYDROCORTISONE SPRAY [21ST CENTURY HEALTHCARE INC.]". https://dailymed.nlm.nih.gov/dailym... (accessed August 28, 2018).
  2. Dailymed."MONISTAT 7 COMBINATION PACK 7-DAY PRE-FILLED APPLICATORS (MICONAZOLE NITRATE) KIT [INSIGHT PHARMACEUTICALS]". https://dailymed.nlm.nih.gov/dailym... (accessed August 28, 2018).
  3. Dailymed."MICONAZOLE: DailyMed provides trustworthy information about marketed drugs in the United States. DailyMed is the official provider of FDA label information (package inserts).". https://dailymed.nlm.nih.gov/dailym... (accessed August 28, 2018).

Frequently asked Questions

Can i drive or operate heavy machine after consuming Daktar Hydrocortison?

Depending on the reaction of the Daktar Hydrocortison after taken, if you are feeling dizziness, drowsiness or any weakness as a reaction on your body, Then consider Daktar Hydrocortison 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 Daktar Hydrocortison 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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Review

sdrugs.com conducted a study on Daktar Hydrocortison, and the result of the survey is set out below. It is noteworthy that the product of the survey is based on the perception and impressions of the visitors of the website as well as the views of Daktar Hydrocortison consumers. We, as a result of this, advice that you do not base your therapeutic or medical decisions on this result, but rather consult your certified medical experts for their recommendations.

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The information was verified by Dr. Rachana Salvi, MD Pharmacology

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