Drugs Details

Drugs Info of Capex, Flurosyn, Synalar, Synalar Ointment
Drugs Details
  • Drugs Type  : FDA
  • Date : 5th Jan 2015 08:14 am
  • Brand Name : Capex, Flurosyn, Synalar, Synalar Ointment
  • Generic Name : fluocinolone topical (Pronunciation: floo oh SIN oh lone TOP i kal)
Descriptions

Capex® Shampoo 0.01% is supplied as a shampoo formulation with a 12 mg fluocinolone acetonide capsule which is emptied into the shampoo base by the pharmacist at the time of dispensing. After mixing, Capex® Shampoo contains fluocinolone acetonide (6α, 9-Difluro-11β, 16α, 17,21 -tetrahydroxypregna-1,4-diene-3, 20-dione cyclic 16,17-acetal with acetone), a synthetic fluorinated corticosteroid for topical dermatologic use. The corticosteroids constitute a class of primarily synthetic steroids used topically as an anti-inflammatory and antipruritic agents.

Chemically, Capex® Shampoo (fluocinolone acetonide topical shampoo) mixture is C24H30F2O8.

It has the following structural formula:

 

Capex® Shampoo (fluocinolone acetonide) Structural Formula Illustration

Fluocinolone acetonide in Capex® Shampoo (fluocinolone acetonide topical shampoo) has the molecular weight of 452.50. It is a white crystalline powder that is odorless, stable in light and melts at 270°F with decomposition; soluble in alcohol, acetone and methanol; slightly soluble in chloroform; insoluble in water.

Each fluocinolone capsule contains 12 mg of fluocinolone acetonide, 548 mg of dibasic calcium phosphate dihydrate USP, and 240 mg of talc USP. The shampoo base contains aluminum acetate basic, benzalkonium chloride solution, boric acid, citric acid anhydrous, cocamido-ether-sulfate complex, cocoamine oxide, lauramide DEA, magnesium aluminum silicate, methylparaben, oat flour, propylene glycol, propylparaben, purified water, and fragrances, with D&C Yellow #10 and FD&C Blue #1 as coloring.

What are the possible side effects of fluocinolone topical (Capex, Flurosyn, Synalar, Synalar Ointment)?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Stop using this medication and call your doctor at once if you have severe irritation of any treated skin, or if you show signs of absorbing fluocinolone topical through your skin, such as:

  • blurred vision, headache;
  • thinning skin, easy bruising;
  • mood changes;
  • weight gain, puffiness in your face; or
  • muscle weakness, feeling...

Read All Potential Side Effects and See Pictures of Capex Shampoo »

This monograph has been modified to include the generic and brand name in many instances.

Indications

Capex® Shampoo (fluocinolone acetonide topical shampoo) is a low- to medium-potency corticosteroid indicated for the treatment of Seborrheic Dermatitis of the scalp. This product has not been proven to be effective in other corticosteroid-responsive dermatoses.

Dosage Administration

The pharmacist must empty the contents of the enclosed capsule into the shampoo base prior to dispensing to the patient. This product should be shaken well prior to use. No more than approximately one (1) ounce of the medicated shampoo should be applied to the scalp area once daily, worked into a lather, and allowed to remain on the scalp for approximately 5 minutes. The hair and scalp should then be rinsed thoroughly with water.

How Supplied

Capex® Shampoo (fluocinolone acetonide topical shampoo) is supplied as a two component package: a capsule which contains the active component fluocinolone acetonide 0.01%, and a separate package of liquid shampoo. The pharmacist must mix the content of the capsule into the base at the time of dispensing. Capex® Shampoo (fluocinolone acetonide topical shampoo) is dispensed to the patient in a 6 ounce bottle.

Shake well before using.

NDC 0299-5500-04

Store between 15° and 30° C (59° and 86° F) in tightly closed containers.

Marketed by: Galderma Laboratories, L.P. Ft. Worth, Texas 76177 USA. Mfd. by: Hill Laboratories, Inc. Sanford, Florida 32773 USA. Revised: July 2000.

This monograph has been modified to include the generic and brand name in many instances.

Side Effects

The following local adverse reactions have been reported infrequently with topical corticosteroids. They may occur more frequently with the use of occlusive dressings, especially with higher potency corticosteroids. These reactions are listed in an approximate decreasing order of occurrence: dryness, folliculitis, acneiform eruptions, perioral dermatitis, allergic contact dermatitis, secondary infection, skin atrophy, striae, miliaria, burning, itching, irritation, and hypopigmentation.

Read the Capex Shampoo (fluocinolone acetonide topical shampoo) Side Effects Center for a complete guide to possible side effects

Learn More »

Interactions

No information provided.

This monograph has been modified to include the generic and brand name in many instances.

Warnings

No information provided.

Precautions

General

Systemic absorption of topical corticosteroids can produce reversible hypothalamic-pituitary-adrenal (HPA) axis suppression with the potential for glucocorticoid insufficiency after withdrawal of treatment. Manifestations of Cushing's syndrome, hyperglycemia, and glucosuria can also be produced in some patients by systemic absorption of topical corticosteroids while on treatment.

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. This may be done by using the ACTH stimulation, A.M. plasma cortisol, and urinary free cortisol tests. Patients receiving superpotent corticosteroids should not be treated for more than 2 weeks at a time and only small areas should be treated at any one time due to the increased risk of HPA suppression.

If HPA axis suppression is noted, an attempt should be made to withdraw the drug, to reduce the frequency of application, or to substitute a less potent corticosteroid. Infrequently, signs and symptoms of glucocorticoid insufficiency may occur requiring supplemental systemic corticosteroids. For information on systemic supplementation, see prescribing information for those products.

Pediatric patients may be more susceptible to systemic toxicity from equivalent doses due to their larger skin surface to body mass ratios. (See PRECAUTIONS — Pediatric Use).

If irritation develops, Capex® Shampoo (fluocinolone acetonide topical shampoo) should be discontinued and appropriate therapy instituted. Allergic contact dermatitis with corticosteroids is usually diagnosed by a 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.

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 Capex® Shampoo (fluocinolone acetonide topical shampoo) should be discontinued until the infection has been adequately controlled.

Laboratory Tests

The following tests may be helpful in evaluating patients for HPA axis suppression.

  • ACTH stimulation test
  • A.M. plasma cortisol test
  • Urinary free cortisol test

Carcinogenesis, mutagenesis, and impairment of fertility

Long-term animal studies have not been performed to evaluate the carcinogenic potential or the effect on fertility of Capex® Shampoo (fluocinolone acetonide topical shampoo) .

Pregnancy

Teratogenic effects: Pregnancy category C: Corticosteroids have been shown to be teratogenic in laboratory animals when administered systemically at relatively low dosage levels. Some corticosteroids have been shown to be teratogenic after dermal application in laboratory animals.

There are no adequate and well-controlled studies in pregnant women or teratogenic effects from Capex® Shampoo (fluocinolone acetonide topical shampoo) . Therefore, Capex® Shampoo (fluocinolone acetonide topical shampoo) should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

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 human milk. Because many drugs are secreted in human milk, caution should be exercised when Capex® Shampoo (fluocinolone acetonide topical shampoo) is administered to a nursing woman.

Pediatric Use

Safety and effectiveness in children and infants 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 when they are treated with topical corticosteroids. They are therefore also at a greater risk of glucocorticoid insufficiency after withdrawal of treatment and of Cushing's syndrome while on treatment. Adverse effects including striae have been reported with inappropriate use of topical corticosteroids in infants and children.

HPA axis suppression, Cushing's syndrome and intracranial hypertension have been reported in children receiving topical corticosteroids. Manifestations of adrenal suppression in children include linear growth retardation, delayed weight gain, low plasma cortisol levels and absence of response to ACTH stimulation. Manifestations of intracranial hypertension include bulging fontanelles, headaches and bilateral papilledema.

This monograph has been modified to include the generic and brand name in many instances.

OverDose

Topically applied Capex® Shampoo (fluocinolone acetonide topical shampoo) can be absorbed in sufficient amounts to produce systemic effects (See PRECAUTIONS).

ContrainDications

Capex® Shampoo (fluocinolone acetonide topical shampoo) is contraindicated in those patients with a history of hypersensitivity to any of the components of the preparation.

This monograph has been modified to include the generic and brand name in many instances.

Clinical Pharamacology

Like other topical corticosteroids, fluocinolone acetonide has anti-inflammatory, antipruritic and vasoconstrictive properties. The mechanism of the anti-inflammatory activity of the topical steroids, in general, is unclear. However, corticosteroids are thought to act by the induction of phospholipase A2 inhibitory proteins, collectively called lipocortins. It is postulated that these proteins control the biosynthesis of potent mediators of inflammation such as prostaglandins and leukotrienes by inhibiting the release of their common precursor arachidonic acid. Arachidonic acid is released from membrane phospholipids by phospholipase A2.

Pharmacokinetics

The extent of percutaneous absorption of topical corticosteroids is determined by many factors including the vehicle and the integrity of the epidermal barrier. Occlusive dressings with hydrocortisone for up to 24 hours have not been demonstrated to increase penetration; however, occlusion of hydrocortisone for 96 hours markedly enhances penetration. Topical corticosteroids can be absorbed from normal intact skin while inflammation and/or other disease processes in the skin increase percutaneous absorption.

Capex® Shampoo (fluocinolone acetonide topical shampoo) is in the low- to medium-potency as compared with other topical corticosteroids.

Clinical Studies

In vehicle-controlled studies for the treatment of Seborrheic Dermatitis of the scalp, after 14 days of treatment, 84% of patients on active treatment and 29% of patients on the drug vehicle had cleared or markedly improved.

This monograph has been modified to include the generic and brand name in many instances.

Patient Information

Patients using topical corticosteroids should receive the following information and instructions:

  1. This medication is to be used as directed by the physician. It is for external use only. Avoid contact with the eyes. In case of contact, wash eyes liberally with water.
  2. This medication should not be used for any disorder other than that for which it was prescribed.
  3. The treated scalp area should not be bandaged or otherwise covered or wrapped so as to be occlusive unless directed by the physician.
  4. Patients should report to their physician any signs of local adverse reactions.
  5. Discard contents after three (3) months.

This monograph has been modified to include the generic and brand name in many instances.

Consumer Overview Uses

No Information Available!

Consumer Overview Side Effect

No Information Available!

Consumer Overview Missed Dose

No Information Available!

Patient Detailed Side Effect

Brand Names: Capex, Flurosyn, Synalar, Synalar Ointment

Generic Name: fluocinolone topical (Pronunciation: floo oh SIN oh lone TOP i kal)

  • What is fluocinolone topical (Capex Shampoo)?
  • What are the possible side effects of fluocinolone topical (Capex Shampoo)?
  • What is the most important information I should know about fluocinolone topical (Capex Shampoo)?
  • What should I discuss with my healthcare provider before using fluocinolone topical (Capex Shampoo)?
  • How should I use fluocinolone topical (Capex Shampoo)?
  • What happens if I miss a dose (Capex Shampoo)?
  • What happens if I overdose (Capex Shampoo)?
  • What should I avoid while using fluocinolone topical (Capex Shampoo)?
  • What other drugs will affect fluocinolone topical (Capex Shampoo)?
  • Where can I get more information?

What is fluocinolone topical (Capex Shampoo)?

Fluocinolone is a steroid. It reduces the actions of chemicals in the body that cause inflammation, redness, and swelling.

Fluocinolone topical (for the skin) is used to treat the inflammation and itching caused by a number of skin conditions such as allergic reactions, eczema, seborrhea, and psoriasis.

Fluocinolone topical may also be used for purposes not listed in this medication guide.

What are the possible side effects of fluocinolone topical (Capex Shampoo)?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Stop using this medication and call your doctor at once if you have severe irritation of any treated skin, or if you show signs of absorbing fluocinolone topical through your skin, such as:

  • blurred vision, headache;
  • thinning skin, easy bruising;
  • mood changes;
  • weight gain, puffiness in your face; or
  • muscle weakness, feeling tired.

Common side effects may include:

  • mild skin itching, burning, peeling, or dryness;
  • thinning or softening of your skin;
  • swollen hair follicles;
  • blisters, pimples, or crusting of treated skin;
  • changes in color of treated skin;
  • skin rash or irritation around your mouth; or
  • stretch marks.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Read the Capex Shampoo (fluocinolone acetonide topical shampoo) Side Effects Center for a complete guide to possible side effects

Learn More »

What is the most important information I should know about fluocinolone topical (Capex Shampoo)?

Do not use this medicine in larger amounts or for longer than recommended. Topical steroid medicine can be absorbed through the skin, which may cause steroid side effects throughout the body.

Do not cover treated skin areas with a bandage or other covering unless your doctor has told you to.

Plastic film covering (such as plastic wrap) is sometimes used when treating psoriasis. Follow your doctor's instructions.

Children can absorb larger amounts of this medication through the skin and may be more likely to have side effects. If you are treating the diaper area of a baby, do not use plastic pants or tight-fitting diapers.

Call your doctor if your symptoms do not improve, if they get worse, or if you develop signs of a skin infection.

Side Effects Centers
  • Synalar
  • Capex Shampoo

Patient Detailed How Take

What should I discuss with my healthcare provider before using fluocinolone topical (Capex Shampoo)?

You should not use this medication if you are allergic to fluocinolone.

To make sure fluocinolone topical is safe for you, tell your doctor if you have any type of skin infection.

Also tell your doctor if you have diabetes. Topical steroid medicines absorbed through the skin may increase the glucose (sugar) levels in your blood or urine.

FDA pregnancy category C. It is not known whether fluocinolone topical will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant while using this medication.

It is not known whether fluocinolone topical passes into breast milk or if it could harm a nursing baby. Do not apply this medication to your chest area if you are breast-feeding a baby.

Children can absorb larger amounts of this medication through the skin and may be more likely to have side effects, or a delay in growth with long-term use. Talk with your doctor if you think your child is not growing at a normal rate while using this medication over a long treatment period.

How should I use fluocinolone topical (Capex Shampoo)?

Follow all directions on your prescription label. Do not use this medicine in larger or smaller amounts or for longer than recommended. Topical steroid medicine can be absorbed through the skin, which may cause steroid side effects throughout the body.

Do not cover treated skin areas with a bandage or other covering unless your doctor has told you to. If you are treating the diaper area of a baby, do not use plastic pants or tight-fitting diapers.

Covering the skin that is treated with fluocinolone topical can increase the amount of medicine your skin absorbs, which may lead to unwanted side effects. However, plastic film covering (such as plastic wrap or a shower cap) is sometimes used when treating psoriasis. Follow your doctor's instructions.

Wash your hands before and after using fluocinolone topical, unless you are using the medication to treat the skin on your hands.

Apply a small amount of the medicine to the affected area and rub it gently into the skin. Do not use this medication over a large area of skin.

If you are using the shampoo form of this medication, apply a small amount (1 ounce or less) to wet hair and work into a lather. Leave the shampoo on the scalp for 5 minutes and then rinse thoroughly.

Call your doctor if your symptoms do not improve, if they get worse, or if you develop signs of a skin infection.

If you use this medication long-term, you may need frequent medical tests at your doctor's office.

Store at room temperature away from moisture and heat. Keep the bottle tightly closed when not in use.

Side Effects Centers
  • Synalar
  • Capex Shampoo

Patient Detailed Avoid Taking

What happens if I miss a dose (Capex Shampoo)?

Use the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not use extra medicine to make up the missed dose.

What happens if I overdose (Capex Shampoo)?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

An overdose of fluocinolone topical is not expected to produce life threatening symptoms. However, long term use of high steroid doses can lead to symptoms such as thinning skin, easy bruising, changes in the shape or location of body fat (especially in your face, neck, back, and waist), increased acne or facial hair, menstrual problems, impotence, or loss of interest in sex.

What should I avoid while using fluocinolone topical (Capex Shampoo)?

Do not use this medicine to treat any skin condition that has not been checked by your doctor.

If this medication gets in your eyes, rinse with water. Do not use fluocinolone topical on broken or infected skin, or in an open wound.

What other drugs will affect fluocinolone topical (Capex Shampoo)?

It is not likely that other drugs you take orally or inject will have an effect on topically applied fluocinolone. But many drugs can interact with each other. Tell each of your health care providers about all medicines you use, including prescription and over-the-counter medicines, vitamins, and herbal products.

Where can I get more information?

Your pharmacist can provide more information about fluocinolone topical.


Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.

Every effort has been made to ensure that the information provided by Cerner Multum, Inc. ('Multum') is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Multum's drug information does not endorse drugs, diagnose patients or recommend therapy. Multum's drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

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  • Capex Shampoo

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