Lidecomb

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Lidecomb uses

Lidecomb consists of Fluocinonide, Gramicidin, Neomycin Sulfate, Nystatin.

Fluocinonide:


1INDICATIONS AND USAGE

Lidecomb Cream is a corticosteroid indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid responsive dermatoses in patients 12 years of age or older. (1)

Limitation of Use:

  • Treatment beyond 2 consecutive weeks is not recommended, and the total dosage should not exceed 60 g per week because of the potential for the drug to suppress the hypothalamic-pituitary-adrenal (HPA) axis. (1)
  • Avoid use on the face, groin, or axillae. (1.2)
  • Avoid use in perioral dermatitis or rosacea. (1.2)

1.1 Indications

VANOS® (fluocinonide) Cream, 0.1% is indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid responsive dermatoses in patients 12 years of age or older [see Use in Specific Populations (8.4) ].

1.2 Limitation of Use

Treatment beyond 2 consecutive weeks is not recommended and the total dosage should not exceed 60 g per week because the safety of Lidecomb (Fluocinonide) Cream for longer than 2 weeks has not been established and because of the potential for the drug to suppress the hypothalamic-pituitary-adrenal (HPA) axis. Therapy should be discontinued when control of the disease is achieved. If no improvement is seen within 2 weeks, reassessment of the diagnosis may be necessary. Do not use more than half of the 120 g tube per week.

Lidecomb (Fluocinonide) Cream should not be used in the treatment of rosacea or perioral dermatitis, and should not be used on the face, groin, or axillae.

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2DOSAGE AND ADMINISTRATION

For topical use only. Lidecomb (Fluocinonide) Cream is not for ophthalmic, oral, or intravaginal use.

For psoriasis, apply a thin layer of Lidecomb (Fluocinonide) Cream once or twice daily to the affected skin areas as directed by a physician. Twice-daily application for the treatment of psoriasis has been shown to be more effective in achieving treatment success during 2 weeks of treatment.

For atopic dermatitis, apply a thin layer of Lidecomb (Fluocinonide) Cream once daily to the affected skin areas as directed by a physician. Once-daily application for the treatment of atopic dermatitis has been shown to be as effective as twice daily treatment in achieving treatment success during 2 weeks of treatment [see Clinical Studies (14) ].

For corticosteroid responsive dermatoses, other than psoriasis or atopic dermatitis, apply a thin layer of Lidecomb (Fluocinonide) Cream once or twice daily to the affected areas as directed by a physician.

For topical use only. Lidecomb (Fluocinonide) Cream is not for ophthalmic, oral, or intravaginal use. (2)

Psoriasis: apply a thin layer once or twice daily to the affected skin areas. (2)

Atopic Dermatitis: apply a thin layer once daily to the affected skin areas. (2)

Corticosteroid Responsive Dermatoses, other than psoriasis or atopic dermatitis: apply a thin layer once or twice daily to the affected areas. (2)

3DOSAGE FORMS AND STRENGTHS

Cream, 0.1%.

Each gram of Lidecomb (Fluocinonide) Cream contains 1 mg of Lidecomb (Fluocinonide) in a white to off-white cream base.

Cream, 0.1% (3)

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4CONTRAINDICATIONS

None.

None (4)

5WARNINGS AND PRECAUTIONS

  • Lidecomb Cream has been shown to suppress the HPA axis. Systemic absorption of Lidecomb (Fluocinonide) Cream may produce reversible hypothalamic-pituitary-adrenal (HPA) axis suppression, Cushing's syndrome, hyperglycemia and unmask latent diabetes. (5.1)
  • Systemic absorption may require evaluation for HPA-axis suppression. (5.1)
  • Modify use should HPA-axis suppression develop. (5.1)
  • Potent corticosteroids, use on large areas, prolonged use or occlusive use may increase systemic absorption. (5.3)
  • Local adverse reactions with topical steroids may include atrophy, striae, irritation, acneiform eruptions, hypopigmentation, and allergic contact dermatitis and may be more likely to occur with occlusive use or more potent corticosteroids. (5.3)
  • Children may be more susceptible to systemic toxicity when treated with topical corticosteroids. (5.1, 8.4)

5.1 Effect on Endocrine System

Systemic absorption of topical corticosteroids, including Lidecomb (Fluocinonide) Cream, can produce reversible hypothalamic-pituitary-adrenal (HPA) axis suppression with the potential for clinical glucocorticosteroid insufficiency. This may occur during treatment or upon withdrawal of the topical corticosteroid. In addition, the use of Lidecomb (Fluocinonide) Cream for longer than 2 weeks may suppress the immune system [see Nonclinical Toxicology (13.1) ].

HPA-axis suppression has been observed with Lidecomb (Fluocinonide) Cream, 0.1% applied once or twice daily in 2 out of 18 adult patients with plaque-type psoriasis, 1 out of 31 adult patients with atopic dermatitis, and 4 out of 123 pediatric patients with atopic dermatitis [see Use in Specific Populations (8.4) and Clinical Pharmacology (12.2)].

Because of the potential for systemic absorption, use of topical corticosteroids, including Lidecomb (Fluocinonide) Cream, may require that patients be periodically evaluated for HPA-axis suppression. Factors that predispose a patient using a topical corticosteroid to HPA-axis suppression include the use of more potent steroids, use over large surface areas, use over prolonged periods, use under occlusion, use on an altered skin barrier, and use in patients with liver failure.

An adrenocorticotropic hormone (ACTH) stimulation test may be helpful in evaluating patients for HPA-axis suppression. If HPA-axis suppression is documented, an attempt should be made to gradually withdraw the drug, to reduce the frequency of application, or to substitute a less potent steroid. Manifestations of adrenal insufficiency may require supplemental systemic corticosteroids. Recovery of HPA-axis function is generally prompt and complete upon discontinuation of topical corticosteroids.

Cushing's syndrome, hyperglycemia, and unmasking of latent diabetes mellitus can also result from systemic absorption of topical corticosteroids.

Use of more than one corticosteroid-containing product at the same time may increase the total systemic absorption of topical corticosteroids.

Studies conducted in pediatric patients demonstrated reversible HPA-axis suppression after use of Lidecomb (Fluocinonide) Cream. Pediatric patients may be more susceptible than adults to systemic toxicity from equivalent doses of Lidecomb (Fluocinonide) Cream due to their larger skin surface-to-body-mass ratios [see Use in Specific Populations (8.4) ].

5.2 Local Adverse Reactions with Topical Corticosteroids

Local adverse reactions may be more likely to occur with occlusive use, prolonged use, or use of higher potency corticosteroids. Reactions may include atrophy, striae, telangiectasis, burning, itching, irritation, dryness, folliculitis, acneiform eruptions, hypopigmentation, perioral dermatitis, allergic contact dermatitis, secondary infection, and miliaria. Some local adverse reactions may be irreversible.

5.3 Concomitant Skin Infections

If concomitant skin infections are present or develop, an appropriate antifungal or antibacterial agent should be used. If a favorable response does not occur promptly, use of Lidecomb Cream should be discontinued until the infection has been adequately controlled.

5.4 Allergic Contact Dermatitis

If irritation develops, Lidecomb (Fluocinonide) Cream should be discontinued and appropriate therapy instituted. Allergic contact dermatitis with corticosteroids is usually diagnosed by observing failure to heal rather than noting a clinical exacerbation as with most topical products not containing corticosteroids. Such an observation should be corroborated with appropriate diagnostic patch testing.

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6ADVERSE REACTIONS

The most commonly reported adverse reactions were headache, application site burning, nasopharyngitis, and nasal congestion. (6)

To report SUSPECTED ADVERSE REACTIONS, contact Valeant Pharmaceuticals North America LLC at 1-800-321-4576 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

6.1 Clinical Trials Experience

Because clinical studies are conducted under widely varying conditions, adverse reaction rates observed in the clinical studies of a drug cannot be directly compared to rates in the clinical studies of another drug and may not reflect the rates observed in practice.

In clinical trials, a total of 443 adult subjects with atopic dermatitis or plaque-type psoriasis were treated once daily or twice daily with Lidecomb (Fluocinonide) Cream for 2 weeks. The most commonly observed adverse reactions in these clinical trials were as follows:

Adverse Reaction Lidecomb (Fluocinonide) Cream,

once daily

(n=216)

Lidecomb (Fluocinonide) Cream,

twice daily

(n=227)

Vehicle Cream,

once or twice daily

(n=211)


Headache


8 (3.7%)


9 (4.0%)


6 (2.8%)


Application Site Burning


5 (2.3%)


4 (1.8%)


14 (6.6%)


Nasopharyngitis


2 (0.9%)


3 (1.3%)


3 (1.4%)


Nasal Congestion


3 (1.4%)


1 (0.4%)


0


Safety in patients 12 to 17 years of age was similar to that observed in adults.

6.2 Postmarketing Experience

The following adverse reactions have been identified during postapproval use of Lidecomb (Fluocinonide) Cream:

Administration Site Conditions: discoloration, erythema, irritation, pruritus, swelling, pain, and condition aggravated.

Immune System Disorders: hypersensitivity.

Nervous System Disorders: headache and dizziness.

Skin and Subcutaneous Tissue Disorders: acne, dry skin, rash, skin exfoliation, and skin tightness.

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.

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8 USE IN SPECIFIC POPULATIONS

8.1 Pregnancy

Teratogenic Effects: Pregnancy Category C

There are no adequate and well-controlled studies in pregnant women. Therefore, Lidecomb Cream should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

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.

8.3 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. Nevertheless, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.

8.4 Pediatric Use

Safety and efficacy of Lidecomb Cream in pediatric patients younger than 12 years of age have not been established; therefore, use in pediatric patients younger than 12 years of age is not recommended.

HPA-axis suppression was studied in four sequential cohorts of pediatric patients with atopic dermatitis covering at least 20% of the body surface area (BSA), treated once daily or twice daily with Lidecomb (Fluocinonide) Cream. The first cohort of 31 patients (mean 36.3% BSA) 12 to <18 years old; the second cohort included 31 patients (mean 39.0% BSA) 6 to <12 years old; the third cohort included 30 patients (mean 34.6% BSA) 2 to <6 years old; the fourth cohort included 31 patients (mean 40.0% BSA) 3 months to <2 years old. Lidecomb (Fluocinonide) Cream caused HPA-axis suppression in 1 patient in the twice-daily group in Cohort 1, 2 patients in the twice-daily group in Cohort 2, and 1 patient in the twice-daily group in Cohort 3. Follow-up testing 14 days after treatment discontinuation, available for all 4 suppressed patients, demonstrated a normally responsive HPA axis. Signs of skin atrophy were present at baseline and severity was not determined, making it difficult to assess local skin safety. Therefore, the safety of Lidecomb (Fluocinonide) Cream in patients younger than 12 years of age has not been demonstrated [see Warnings and Precautions (5.2) ].

HPA-axis suppression has not been evaluated in patients with psoriasis who are less than 18 years of age.

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 greater risk of adrenal insufficiency during or after withdrawal of treatment. Adverse effects including striae have been reported with inappropriate use of topical corticosteroids in infants and children.

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 absence of response to cosyntropin (ACTH1–24) stimulation. Manifestations of intracranial hypertension include bulging fontanelles, headaches, and bilateral papilledema.

8.5 Geriatric Use

Clinical studies of Lidecomb (Fluocinonide) Cream did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects.

10OVERDOSAGE

Topically applied Lidecomb (Fluocinonide) Cream can be absorbed in sufficient amounts to produce systemic effects [see Warnings and Precautions (5.1) ].

11DESCRIPTION

Lidecomb (Fluocinonide) (fluocinonide) Cream, 0.1% contains Lidecomb (Fluocinonide), a synthetic corticosteroid for topical dermatologic use. The corticosteroids constitute a class of primarily synthetic steroids used topically as anti-inflammatory and antipruritic agents. Lidecomb (Fluocinonide) has the chemical name 6 alpha, 9 alpha-difluoro-11 beta, 21-dihydroxy-16 alpha, 17 alpha-isopropylidenedioxypregna-1, 4-diene-3,20-dione 21-acetate. Its chemical formula is C26H32F2O7 and it has a molecular weight of 494.58.

It has the following chemical structure:

Lidecomb (Fluocinonide) is an almost odorless white to creamy white crystalline powder. It is practically insoluble in water and slightly soluble in ethanol.

Each gram of Lidecomb (Fluocinonide) Cream contains 1 mg micronized Lidecomb (Fluocinonide) in a cream base of anhydrous citric acid USP, carbopol 980 NF, diisopropanolamine, dimethyl isosorbide, glyceryl monostearate NF, glyceryl stearate (and) PEG-100 stearate, propylene glycol USP, and purified water USP.

Chemical Structure

12CLINICAL 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 of Lidecomb Cream in corticosteroid responsive dermatoses is unknown.

12.2 Pharmacodynamics

Vasoconstrictor studies performed with Lidecomb (Fluocinonide) Cream in healthy subjects indicate that it is in the super-high range of potency as compared with other topical corticosteroids; however, similar blanching scores do not necessarily imply therapeutic equivalence.

Application of Lidecomb (Fluocinonide) Cream twice daily for 14 days in 18 adult subjects with plaque-type psoriasis (10–50% BSA, mean 19.6% BSA) and 31 adult subjects (17 treated once daily; 14 treated twice daily) with atopic dermatitis (2–10% BSA, mean 5% BSA) showed demonstrable HPA-axis suppression in 2 subjects with psoriasis (with 12% and 25% BSA) and 1 subject with atopic dermatitis (treated once daily, 4% BSA) where the criterion for HPA-axis suppression is a serum cortisol level of less than or equal to 18 micrograms per deciliter 30 minutes after stimulation with cosyntropin (ACTH1–24) [see Warnings and Precautions (5.1) ].

HPA-axis suppression following application of Lidecomb (Fluocinonide) Cream, 0.1% (once or twice daily) was also evaluated in 123 pediatric patients from 3 months to <18 years of age with atopic dermatitis (mean BSA range 34.6%-40.0%). HPA-axis suppression was observed in 4 patients in the twice-daily groups. Follow-up testing 14 days after treatment discontinuation demonstrated a normally responsive HPA axis in all 4 suppressed patients [see Warnings and Precautions (5.1) and Use in Specific Populations (8.4) ].

12.3Pharmacokinetics

The extent of percutaneous absorption of topical corticosteroids is determined by many factors including the vehicle and the integrity of the epidermal barrier. Topical corticosteroids can be absorbed from normal intact skin. Inflammation and/or other disease processes in the skin may increase percutaneous absorption.

13NONCLINICAL TOXICOLOGY

13.1Carcinogenesis, Mutagenesis, Impairment of Fertility

Long-term animal studies have not been performed to evaluate the carcinogenic potential of Lidecomb (Fluocinonide) Cream because of severe immunosuppression induced in a 13-week dermal rat study. The effects of Lidecomb (Fluocinonide) on fertility have not been evaluated.

Lidecomb (Fluocinonide) revealed no evidence of mutagenic or clastogenic potential based on the results of two in vitro genotoxicity tests (Ames test and chromosomal aberration assay using human lymphocytes). However, Lidecomb (Fluocinonide) was positive for clastogenic potential when tested in the in vivo mouse micronucleus assay.

Topical (dermal) application of 0.0003%–0.03% Lidecomb (Fluocinonide) cream to rats once daily for 13 weeks resulted in a toxicity profile generally associated with long-term exposure to corticosteroids including decreased skin thickness, adrenal atrophy, and severe immunosuppression. A NOAEL could not be determined in this study. In addition, topical (dermal) application of 0.1% Lidecomb (Fluocinonide) cream plus ultraviolet radiation (UVR) exposure to hairless mice for 13 weeks and 150–900 mg/kg/day of 0.1% Lidecomb (Fluocinonide) cream to minipigs (a model which more closely approximates human skin) for 13 weeks produced glucocorticoid-related suppression of the HPA axis, with some signs of immunosuppression noted in the dermal minipig 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 for carcinogenesis.

Topical doses of 0% (fluocinonide cream vehicle), 0.0001%, 0.005%, and 0.001% Lidecomb (Fluocinonide) cream were evaluated in a 52-week dermal photocarcinogenicity study (40 weeks of treatment followed by 12 weeks of observation) conducted in hairless albino mice with concurrent exposure to low level ultraviolet radiation. Topical treatment with increasing concentrations of Lidecomb (Fluocinonide) cream did not have an adverse effect in this study. The results of this study suggest that topical treatment with Lidecomb (Fluocinonide) Cream would not enhance photocarcinogenesis.

14CLINICAL STUDIES

Two adequate and well-controlled efficacy and safety studies of Lidecomb (Fluocinonide) Cream have been completed, one in adult subjects with plaque-type psoriasis (Table 2), and one in adult subjects with atopic dermatitis (Table 3). In each of these studies, subjects with between 2% and 10% body surface area involvement at baseline treated all affected areas either once daily or twice daily with Lidecomb (Fluocinonide) Cream for 14 consecutive days. The primary measure of efficacy was the proportion of subjects whose condition was cleared or almost cleared at the end of treatment. The results of these studies are presented in the tables below as percent and number of patients achieving treatment success at Week 2.

Lidecomb (Fluocinonide) Cream,

once daily

(n=107)

Vehicle,

once daily

(n=54)

Lidecomb (Fluocinonide) Cream,

twice daily

(n=107)

Vehicle,

twice daily

(n=55)


Subjects cleared


0 (0)


0 (0)


6 (6%)


0 (0)


Subjects achieving treatment successCleared or almost cleared


19 (18%)


4 (7%)


33 (31%)


3 (5%)

Lidecomb (Fluocinonide) Cream,

once daily

(n=109)

Vehicle,

once daily

(n=50)

Lidecomb (Fluocinonide) Cream,

twice daily

(n=102)

Vehicle,

twice daily

(n=52)


Subjects cleared


11 (10%)


0 (0)


17 (17%)


0 (0)


Subjects achieving treatment successCleared or almost cleared


64 (59%)


6 (12%)


58 (57%)


10 (19%)


No efficacy studies have been conducted to compare Lidecomb (Fluocinonide) (fluocinonide) Cream, 0.1% with any other topical corticosteroid product, including Lidecomb (Fluocinonide) cream 0.05%.

16HOW SUPPLIED/STORAGE AND HANDLING

VANOS® (fluocinonide) Cream, 0.1% is white to off-white in color and is supplied in tubes as follows:

  • 30 g NDC 99207-525-30
  • 60 g NDC 99207-525-60
  • 120 g NDC 99207-525-10

Store at controlled room temperature 15° to 30°C (59° to 86°F).

Keep the tube tightly closed.

17PATIENT COUNSELING INFORMATION

Advise the patient to read the FDA-approved patient labeling (Patient Information).

Patients using Lidecomb (Fluocinonide) Cream should receive the following information and instructions. This information is intended to aid in the safe and effective use of this medication. It is not a disclosure of all possible adverse or unintended effects:

  • Lidecomb (Fluocinonide) Cream is to be used as directed by the physician. It is for external use only. Avoid contact with the eyes. It should not be used on the face, groin, and underarms.
  • Lidecomb (Fluocinonide) Cream should not be used for any disorder other than that for which it was prescribed.
  • The treated skin area should not be bandaged or otherwise covered or wrapped, so as to be occlusive unless directed by the physician.
  • Patients should report to their physician any signs of local adverse reactions.
  • Other corticosteroid-containing products should not be used with Lidecomb (Fluocinonide) Cream without first talking to the physician.
  • As with other corticosteroids, therapy should be discontinued when control is achieved. If no improvement is seen in 2 weeks, the patient should be instructed to contact a physician. The safety of the use of Lidecomb (Fluocinonide) Cream for longer than 2 weeks has not been established.
  • Patients should be informed to not use more than 60 g per week of Lidecomb (Fluocinonide) Cream. Do not use more than half of the 120 g tube per week.
  • Patients should inform their physicians that they are using Lidecomb (Fluocinonide) Cream if surgery is contemplated.
  • Patients should wash their hands after applying medication.

Manufactured for:

Valeant Pharmaceuticals North America LLC

Bridgewater, NJ 08807 USA

By:

Valeant Pharmaceuticals International, Inc.

Laval, Quebec H7L 4A8, Canada

U.S. Patent Numbers 6,765,001; 7,217,422; 7,220,424; 7,771,733; 7,794,738 and 8,232,264

Lidecomb (Fluocinonide) is a trademark of Valeant Pharmaceuticals

International, Inc. or its affiliates.

©Valeant Pharmaceuticals North America LLC

9481801

Patient Information

VANOS® (VAN-ōs) (fluocinonide)

Cream, 0.1%

IMPORTANT: For skin use only. Do not get Lidecomb (Fluocinonide) Cream in your eyes, mouth, or vagina. Not for use on the face, groin, or underarms.

Read the Patient Information that comes with Lidecomb (Fluocinonide) Cream before you start using it and each time you get a refill. There may be new information. This leaflet does not take the place of talking to your doctor about your condition or treatment.

What is Lidecomb (Fluocinonide) Cream?

Lidecomb (Fluocinonide) Cream is a prescription corticosteroid medicine used on the skin (topical) to treat adults and children 12 years and older with certain skin conditions that cause red, flaky, and itchy skin.

  • You should not use Lidecomb (Fluocinonide) Cream for longer than 2 weeks in a row.
  • You should not use more than 60 grams of Lidecomb (Fluocinonide) Cream or more than half of the 120 gram tube in 1 week.
  • Lidecomb (Fluocinonide) Cream should not be used:
    • if you have skin swelling or redness on the nose or face (rosacea)
    • for a scaly or bumpy rash around your mouth (perioral dermatitis)
    • on your face, underarms, or groin area

It is not known if Lidecomb (Fluocinonide) Cream is safe and effective in children under 12 years of age.

What should I tell my doctor before using Lidecomb (Fluocinonide) Cream?

Before using Lidecomb (Fluocinonide) Cream, tell your doctor if you:

  • have had irritation or other skin reaction to a steroid medicine in the past
  • adrenal gland problems
  • plan to have surgery
  • are pregnant or plan to become pregnant. It is not known if Lidecomb (Fluocinonide) Cream will harm your unborn baby. Talk to your doctor if you are pregnant or plan to become pregnant.
  • are breast-feeding or plan to breastfeed. It is not known if Lidecomb (Fluocinonide) Cream passes into your breast milk. Talk to your doctor about the best way to feed your baby if you use Lidecomb (Fluocinonide) Cream.

Tell your doctor about all the medicine you take including prescription and nonprescription medicines, vitamins, and herbal supplements. Especially tell your doctor if you take a corticosteroid medicine by mouth or use other products on your skin that contain corticosteroids. Ask your doctor or pharmacist if you are not sure.

Know the medicines you take. Keep a list of your medicines with you to show your doctor and pharmacist when you get a new medicine.

How should I use Lidecomb (Fluocinonide) Cream?

  • See "What is Lidecomb (Fluocinonide) Cream?"
  • Use Lidecomb (Fluocinonide) Cream exactly as your doctor tells you.
  • This medicine is for use on the skin only. Do not use Lidecomb (Fluocinonide) Cream in your eyes, mouth, or vagina.
  • Wash your hands after you use Lidecomb (Fluocinonide) Cream.
  • Do not use Lidecomb (Fluocinonide) Cream for longer than 2 weeks in a row.
  • Talk to your doctor if your skin does not get better after 2 weeks of treatment with Lidecomb (Fluocinonide) Cream.
  • Do not bandage or cover the skin treated with Lidecomb (Fluocinonide) Cream unless your doctor tells you to.

What are the possible side effects with Lidecomb (Fluocinonide) Cream?

Lidecomb (Fluocinonide) Cream may cause side effects, including:

  • Symptoms of a disorder where the adrenal gland does not make enough of certain hormones (adrenal insufficiency) during treatment or after stopping treatment. Your doctor may do blood tests to check you for adrenal insufficiency while you are using Lidecomb (Fluocinonide) Cream. Tell your doctor if you have any of these symptoms of adrenal insufficiency:
    • tiredness that worsens and does not go away
    • nausea or vomiting
    • dizziness or fainting
    • muscle weakness
    • irritability and depression
    • loss of appetite
    • weight loss
  • Cushing's syndrome, when the body is exposed to too much of the hormone cortisol. Your doctor may do tests to check for this. Symptoms can include:
    • weight gain, especially around your upper back and midsection
    • slow healing of cuts, insect bites, and infections
    • tiredness and muscle weakness
    • depression, anxiety, and irritability
    • roundness of your face (moon face)
    • new or worsening high blood pressure

The most common side effect of Lidecomb (Fluocinonide) Cream is burning of your skin treated with Lidecomb (Fluocinonide) Cream.

Talk to your doctor about any side effect that bothers you or that does not go away.

These are not all the side effects with Lidecomb (Fluocinonide) Cream. Ask your doctor or pharmacist for more information.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

You may also report side effects to Valeant Pharmaceuticals North America LLC at 1-800-321-4576.

How should I store Lidecomb (Fluocinonide) Cream?

  • Store Lidecomb (Fluocinonide) Cream at room temperature, between 59° to 86°F (15° to 30°C).
  • Keep the tube tightly closed.

Keep Lidecomb (Fluocinonide) Cream and all medicines out of reach of children.

General information about Lidecomb (Fluocinonide) Cream

Medicines are sometimes prescribed for purposes other than those listed in the Patient Information leaflet. Do not use Lidecomb (Fluocinonide) Cream for a condition for which it was not prescribed. Do not give Lidecomb (Fluocinonide) Cream to other people, even if they have the same symptoms you have. It may harm them.

This Patient Information leaflet summarizes the most important information about Lidecomb (Fluocinonide) Cream. If you would like more information, talk with your doctor. You can also ask your pharmacist or doctor for information about Lidecomb (Fluocinonide) Cream that is written for healthcare professionals.

What are the ingredients in Lidecomb (Fluocinonide) Cream?

Active ingredient: Lidecomb (Fluocinonide) 0.1%

Inactive ingredients: anhydrous citric acid USP, carbopol 980 NF, diisopropanolamine, dimethyl isosorbide, glyceryl monostearate NF, glyceryl stearate (and) PEG-100 stearate, propylene glycol USP, and purified water USP.

This Patient Information has been approved by the U.S. Food and Drug Administration.

Manufactured for:

Valeant Pharmaceuticals North America LLC

Bridgewater, NJ 08807 USA

By:

Valeant Pharmaceuticals International, Inc.

Laval, Quebec H7L 4A8, Canada

U.S. Patent Numbers 6,765,001; 7,217,422; 7,220,424; 7,771,733; 7,794,738 and 8,232,264

Lidecomb (Fluocinonide) is a trademark of Valeant Pharmaceuticals

International, Inc. or its affiliates.

©Valeant Pharmaceuticals North America LLC

Rev. 05/2017

9481801

Neomycin Sulfate:


INDICATIONS AND USAGE

To reduce the development of drug-resistant bacteria and maintain the effectiveness of Lidecomb (Neomycin Sulfate) tablets and other antibacterial drugs, Lidecomb (Neomycin Sulfate) tablets should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.

Suppression of Intestinal Bacteria

Lidecomb (Neomycin Sulfate) tablets are indicated as adjunctive therapy as part of a regimen for the suppression of the normal bacterial flora of the bowel, e.g., preoperative preparation of the bowel. It is given concomitantly with erythromycin enteric-coated base (see DOSAGE AND ADMINISTRATION ).

Hepatic Coma (Portal-Systemic Encephalopathy)

Lidecomb (Neomycin Sulfate) has been shown to be effective adjunctive therapy in hepatic coma by reduction of the ammonia-forming bacteria in the intestinal tract. The subsequent reduction in blood ammonia has resulted in neurologic improvement.

CONTRAINDICATIONS

Lidecomb (Neomycin Sulfate) oral preparations are contraindicated in the presence of intestinal obstruction and in individuals with a history of hypersensitivity to the drug.

Patients with a history of hypersensitivity or serious toxic reaction to other aminoglycosides may have a cross-sensitivity to neomycin. Lidecomb (Neomycin Sulfate) oral preparations are contraindicated in patients with inflammatory or ulcerative gastrointestinal disease because of the potential for enhanced gastrointestinal absorption of neomycin.

WARNINGS


Additional manifestations of neurotoxicity may include numbness, skin tingling, muscle twitching and convulsions.

The risk of hearing loss continues after drug withdrawal. Aminoglycosides can cause fetal harm when administered to a pregnant woman.

Aminoglycoside antibiotics cross the placenta and there have been several reports of total irreversible bilateral congenital deafness in children whose mothers received streptomycin during pregnancy. Although serious side effects to fetus or newborn have not been reported in the treatment of pregnant women with other aminoglycosides, the potential for harm exists. Animal reproduction studies of neomycin have not been conducted. If neomycin is used during pregnancy, or if the patient becomes pregnant while taking this drug, the patient should be apprised of the potential hazard to the fetus.

PRECAUTIONS

General

Prescribing Lidecomb tablets in the absence of a proven or strongly suspected bacterial infection or a prophylactic indication is unlikely to provide benefit to the patient and increases the risk of the development of drug-resistant bacteria.

As with other antibiotics, use of oral neomycin may result in overgrowth of nonsusceptible organisms, particularly fungi. If this occurs, appropriate therapy should be instituted.

Neomycin is quickly and almost totally absorbed from body surfaces (except the urinary bladder) after local irrigation and when applied topically in association with surgical procedures. Delayed-onset irreversible deafness, renal failure and death due to neuromuscular blockade (regardless of the status of renal function) have been reported following irrigation of both small and large surgical fields with minute quantities of neomycin.

Cross-allergenicity among aminoglycosides has been demonstrated.

Aminoglycosides should be used with caution in patients with muscular disorders such as myasthenia gravis or parkinsonism since these drugs may aggravate muscle weakness because of their potential curare-like effect on the neuromuscular junction.

Small amounts of orally administered neomycin are absorbed through intact intestinal mucosa.

There have been many reports in the literature of nephrotoxicity and/or ototoxicity with oral use of neomycin. If renal insufficiency develops during oral therapy, consideration should be given to reducing the drug dosage or discontinuing therapy.

An oral neomycin dose of 12 grams per day produces a malabsorption syndrome for a variety of substances, including fat, nitrogen, cholesterol, carotene, glucose, xylose, lactose, sodium, calcium, cyanocobalamin and iron.

Orally administered neomycin increases fecal bile acid excretion and reduces intestinal lactase activity.

Information for The Patient

Patients should be counseled that antibacterial drugs including Lidecomb (Neomycin Sulfate) tablets should only be used to treat bacterial infections. They do not treat viral infections (e.g., the common cold). When Lidecomb (Neomycin Sulfate) tablets are prescribed to treat a bacterial infection, patients should be told that although it is common to feel better early in the course of therapy, the medication should be taken exactly as directed. Skipping doses or not completing the full course of therapy may (1) decrease the effectiveness of the immediate treatment and (2) increase the likelihood that bacteria will develop resistance and will not be treatable by Lidecomb (Neomycin Sulfate) tablets or other antibacterial drugs in the future.

Before administering the drug, patients or members of their families should be informed of possible toxic effects on the eighth nerve. The possibility of acute toxicity increases in premature infants and neonates.

Laboratory Tests

Patients with renal insufficiency may develop toxic neomycin blood levels unless doses are properly regulated. If renal insufficiency develops during treatment, the dosage should be reduced or the antibiotic discontinued. To avoid nephrotoxicity and eighth nerve damage associated with high doses and prolonged treatment, the following should be performed prior to and periodically during therapy: urinalysis for increased excretion of protein, decreased specific gravity, casts and cells; renal function tests such as serum creatinine, BUN or creatinine clearance; tests of the vestibulocochlearis nerve function.

Serial, vestibular and audiometric tests should be performed (especially in high-risk patients). Since elderly patients may have reduced renal function which may not be evident in the results of routine screening tests such as BUN or serum creatinine, a creatinine clearance determination may be more useful.

Drug Interactions

Caution should be taken in concurrent or serial use of other neurotoxic and/or nephrotoxic drugs because of possible enhancement of the nephrotoxicity and/or ototoxicity of neomycin (see boxed WARNINGS ).

Caution should also be taken in concurrent or serial use of other aminoglycosides and polymyxins because they may enhance neomycin’s nephrotoxicity and/or ototoxicity and potentiate neomycin sulfate’s neuromuscular blocking effects.

Oral neomycin inhibits the gastrointestinal absorption of penicillin V, oral vitamin B-12, methotrexate and 5-fluorouracil. The gastrointestinal absorption of digoxin also appears to be inhibited. Therefore, digoxin serum levels should be monitored.

Oral Lidecomb (Neomycin Sulfate) may enhance the effect of coumarin in anticoagulants by decreasing vitamin K availability.

Carcinogenesis, Mutagenesis, Impairment of Fertility

No long-term animal studies have been performed with Lidecomb to evaluate carcinogenic or mutagenic potential or impairment of fertility.

Pregnancy Category D

See WARNINGS section.

Nursing Mothers

It is not known whether neomycin is excreted in human milk, but it has been shown to be excreted in cow milk following a single intramuscular injection. Other aminoglycosides have been shown to be excreted in human milk. Because of the potential for serious adverse reactions from the aminoglycosides in nursing infants, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.

Pediatric Use

The safety and efficacy of oral Lidecomb (Neomycin Sulfate) in patients less than 18 years of age have not been established. If treatment of a patient less than 18 years of age is necessary, neomycin should be used with caution and the period of treatment should not exceed two weeks because of absorption from the gastrointestinal tract.

ADVERSE REACTIONS

The most common adverse reactions to oral Lidecomb (Neomycin Sulfate) are nausea, vomiting and diarrhea. The "Malabsorption Syndrome" characterized by increased fecal fat, decreased serum carotene and fall in xylose absorption has been reported with prolonged therapy. Nephrotoxicity, ototoxicity and neuromuscular blockage have been reported (see boxed WARNINGS and PRECAUTIONS sections).

OVERDOSAGE

Because of low absorption, it is unlikely that acute overdosage would occur with oral Lidecomb (Neomycin Sulfate). However, prolonged administration could result in sufficient systemic drug levels to produce neurotoxicity, ototoxicity and/or nephrotoxicity.

Hemodialysis will remove Lidecomb (Neomycin Sulfate) from the blood.

DOSAGE AND ADMINISTRATION

To minimize the risk of toxicity, use the lowest possible dose and the shortest possible treatment period to control the condition. Treatment for periods longer than two weeks is not recommended.

Hepatic Coma

For use as an adjunct in the management of hepatic coma, the recommended dose is 4 to 12 grams per day given in the following regimen:

  • Withdraw protein from diet. Avoid use of diuretic agents.
  • Give supportive therapy, including blood products, as indicated.
  • Give Lidecomb (Neomycin Sulfate) tablets in doses of 4 to 12 grams of Lidecomb (Neomycin Sulfate) per day (eight to 24 tablets) in divided doses. Treatment should be continued over a period of five to six days, during which time protein should be returned incrementally to the diet.
  • If less potentially toxic drugs cannot be used for chronic hepatic insufficiency, neomycin in doses of up to four grams daily (eight tablets per day) may be necessary. The risk for the development of neomycin-induced toxicity progressively increases when treatment must be extended to preserve the life of a patient with hepatic encephalopathy who has failed to fully respond. Frequent periodic monitoring of these patients to ascertain the presence of drug toxicity is mandatory (see PRECAUTIONS ). Also, neomycin serum concentrations should be monitored to avoid potentially toxic levels. The benefits to the patient should be weighed against the risks of nephrotoxicity, permanent ototoxicity and neuromuscular blockade following the accumulation of neomycin in the tissues.

Preoperative Prophylaxis for Elective Colorectal Surgery

Listed below is an example of a recommended bowel preparation regimen. A proposed surgery time of 8:00 a.m. has been used.

Pre-op Day 3: Minimum residue or clear liquid diet. Bisacodyl, 1 tablet orally at 6:00 p.m.

Pre-op Day 2: Minimum residue or clear liquid diet. Magnesium sulfate, 30 mL, 50% solution (15 g) orally at 10:00 a.m., 2:00 p.m., and 6:00 p.m. Enema at 7:00 p.m. and 8:00 p.m.

Pre-op Day 1: Clear liquid diet. Supplemental (IV) fluids as needed. Magnesium sulfate, 30 mL, 50% solution (15 g) orally at 10:00 a.m., and 2:00 p.m. Lidecomb (Neomycin Sulfate) (1 g) and erythromycin base (1 g) orally at 1:00 p.m., 2:00 p.m. and 11:00 p.m. No enema.

Day of Operation: Patient evacuates rectum at 6:30 a.m. for scheduled operation at 8:00 a.m.

HOW SUPPLIED

Lidecomb (Neomycin Sulfate) tablets USP, 500 mg (equivalent to 350 mg of neomycin base per tablet) are available as white to off-white, round, standard convex tablets debossed "LCI" on one side and "1210", on the other side and are supplied in:

Bottles of 100 (NDC 0527-1210-01)

Store at 20° to 25°C (68° to 77°F).

Dispense in tight containers as defined in the USP/NF.

Distributed By:

Lannett Company, Inc.

Philadelphia, PA 19154

Made in the USA

Rev. 01/17

CIB71710A

Nystatin:


DESCRIPTION

Lidecomb (Nystatin), USP is an antimycotic polyene antibiotic obtained from Streptomyces noursei. Its structural formula:

  • C47H75NO17 M.W. 926.13

Lidecomb (Nystatin) Tablets USP contain the inactive ingredients: Corn Starch, Povidone, Compressible Sugar, Microcrystalline Cellulose, Sodium Starch Glycolate, Talc, Magnesium Stearate, Purified Water, and Coloring.

Structural formula for Lidecomb (Nystatin)

CLINICAL PHARMACOLOGY

Pharmacokinetics

Gastrointestinal absorption of Lidecomb is insignificant. Most orally administered Lidecomb (Nystatin) is passed unchanged in the stool. In patients with renal insufficiency receiving oral therapy with conventional dosage forms, significant plasma concentrations of Lidecomb (Nystatin) may occasionally occur.

Microbiology

Lidecomb (Nystatin) is both fungistatic and fungicidal in vitro against a wide variety of yeasts and yeast like fungi. Candida albicans demonstrates no significant resistance to Lidecomb (Nystatin) in vitro on repeated subculture in increasing levels of Lidecomb (Nystatin); other Candida species become quite resistant. Generally, resistance does not develop in vivo. Lidecomb (Nystatin) acts by binding to sterols in the cell membrane of susceptible Candida species with a resultant change in membrane permeability allowing leakage of intracellular components. Lidecomb (Nystatin) exhibits no appreciable activity against bacteria, protozoa, or viruses.

INDICATIONS AND USAGE

Lidecomb (Nystatin) tablets are intended for the treatment of non-esophageal mucus membrane gastrointestinal candidiasis.

CONTRAINDICATIONS

Lidecomb (Nystatin) tablets are contraindicated in patients with a history of hypersensitivity to any of their components.

PRECAUTIONS

General

This medication is not to be used for the treatment of systemic mycoses. Discontinue treatment if sensitization or irritation is reported during use.

Carcinogenesis, Mutagenesis, Impairment of Fertility

No long-term animal studies have been performed to evaluate carcinogenic potential. There also have been no studies to determine mutagenicity or whether this medication affects fertility in males or females.

Pregnancy

Teratogenic Effects

Pregnancy Category C

Animal reproduction studies have not been conducted with Lidecomb. It is also not known whether Lidecomb (Nystatin) can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Lidecomb (Nystatin) should be given to a pregnant woman only if clearly needed.

Nursing Mothers

It is not known whether Lidecomb (Nystatin) is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when Lidecomb (Nystatin) is administered to a nursing woman.

ADVERSE REACTIONS

Lidecomb is well tolerated even with prolonged therapy. Oral irritation and sensitization have been reported (see PRECAUTIONS, General).

Gastrointestinal

Diarrhea (including one case of bloody diarrhea), nausea, vomiting, gastrointestinal upset/disturbances.

Dermatologic

Rash, including urticaria has been reported rarely. Stevens-Johnson syndrome has been reported very rarely.

Other

Tachycardia, bronchospasm, facial swelling, and nonspecific myalgia have also been rarely reported.

OVERDOSAGE

Oral doses of Lidecomb (Nystatin) in excess of five million units daily have caused nausea and gastrointestinal upset. There have been no reports of serious toxic effects of superinfections (see CLINICAL PHARMACOLOGY, Pharmacokinetics).

DOSAGE AND ADMINISTRATION

The usual therapeutic dosage is one to two tablets (500,000 to 1,000,000 units Lidecomb (Nystatin)) three times daily. Treatment should generally be continued for at least 48 hours after clinical cure to prevent relapse.

HOW SUPPLIED

Lidecomb (Nystatin) Tablets USP, 500,000 Units are round, convex, brown, film-coated tablet debossed with 93 on one side and 983 on the reverse and are packaged in bottles of 100 tablets (NDC 0093-0983-01).

Store at 20° to 25°C (68° to 77°F).

Dispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure (as required).

Keep tightly closed.

KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN.

Manufactured By:

TEVA CANADA LIMITED

Toronto, Canada M1B 2K9

Manufactured For:

TEVA PHARMACEUTICALS USA, INC.

North Wales, PA 19454

Rev. N 2/2016

NDC 0093-0983-01

Lidecomb (Nystatin)

Tablets USP

500,000 units (oral)

Rx only

100 TABLETS

TEVA

Lidecomb 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.


Lidecomb 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.


Lidecomb 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.


Lidecomb 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.


Lidecomb 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."NYSTATIN TABLET, FILM COATED [TEVA PHARMACEUTICALS USA INC]". https://dailymed.nlm.nih.gov/dailym... (accessed August 28, 2018).
  2. Dailymed."VANOS (FLUOCINONIDE) CREAM [VALEANT PHARMACEUTICALS NORTH AMERICA LLC]". https://dailymed.nlm.nih.gov/dailym... (accessed August 28, 2018).
  3. Dailymed."NEOMYCIN SULFATE TABLET [LANNETT COMPANY, INC.]". https://dailymed.nlm.nih.gov/dailym... (accessed August 28, 2018).

Frequently asked Questions

Can i drive or operate heavy machine after consuming Lidecomb?

Depending on the reaction of the Lidecomb after taken, if you are feeling dizziness, drowsiness or any weakness as a reaction on your body, Then consider Lidecomb 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 Lidecomb 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 Lidecomb, 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 Lidecomb 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. Arunabha Ray, MD Pharmacology

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