Capex

Capex is the brand name of a shampoo that contains fluocinolone. It's used to treat seborrheic dermatitis (severe dandruff) of the scalp.

The medicine in the shampoo is a topical corticosteroid. It works by reducing swelling, itching, flaking, and redness caused by dandruff.

Capex is available in over-the-counter (OTC) and prescription forms.

The Food and Drug Administration (FDA) first approved a formulation of fluocinolone in 1963. Capex is marketed by Galderma Laboratories, L.P.

Capex Warnings

Before using Capex shampoo, tell your doctor if you have, or have had:

• Measles, chickenpox, or tuberculosis (TB)
• A positive tuberculin skin test
• A recent vaccination
• Hardening or thinning of the skin
• A skin infection
• Other skin or scalp conditions
• Allergies to medicines

Avoid getting Capex in your eyes. If this happens, rinse them thoroughly with water.

Don't use Capex if you have an infection or sore in the area to be treated.

Talk with your doctor before receiving any vaccinations while using this product.

Tell your doctor you use Capex before having any type of surgery, including a dental procedure.

Corticosteroids may affect growth in kids and teens. Talk to your doctor if this is a concern.

This product shouldn't be used by anyone under age 12 without first talking with a doctor.

Tell your healthcare provider if your condition doesn't improve or worsens while using Capex.

Pregnancy and Capex

It's not known whether Capex may harm an unborn baby.

Talk to your doctor if you're pregnant or might become pregnant while using this medicine. You'll need to discuss the benefits and risks of using Capex during pregnancy.

It's also not known if this drug passes into breast milk. Talk to your doctor before taking Capex if you're breastfeeding.

In the U.S.

• Capex
• Derma-Smoothe/FS
• Synalar

In Canada

• Fluoderm Mild Cream
• Fluoderm Mild Ointment
• Fluoderm Regular Cream
• Fluoderm Regular Ointment
• Fluolar Mild
• Fluolar Regular
• Fluonide Mild-Cream
• Synalar Mild
• Synalar Regular
• Synamol

Available Dosage Forms:

• Cream
• Solution
• Shampoo
• Oil
• Ointment
• Lotion
• Gel/Jelly
• Kit

Therapeutic Class: Corticosteroid, Intermediate

Pharmacologic Class: Fluocinolone

• Tell all of your health care providers that you take Capex. This includes your doctors, nurses, pharmacists, and dentists.
• Do not use to treat diaper rash.
• Talk with your doctor before you use other drugs or products on your skin.
• Do not put on cuts, scrapes, or damaged skin.
• Use care when putting on a large part of the skin or where there are open wounds. Talk with the doctor.
• Do not use longer than you have been told by the doctor.
• Use with care in children. Talk with the doctor.
• This medicine may affect growth in children and teens in some cases. They may need regular growth checks. Talk with the doctor.
• Tell your doctor if you are pregnant or plan on getting pregnant. You will need to talk about the benefits and risks of using this medicine while you are pregnant.
• Tell your doctor if you are breast-feeding. You will need to talk about any risks to your baby.

WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:

• Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
• Signs of high blood sugar like confusion, feeling sleepy, more thirst, more hungry, passing urine more often, flushing, fast breathing, or breath that smells like fruit.
• Signs of a weak adrenal gland like a very bad upset stomach or throwing up, very bad dizziness or passing out, muscle weakness, feeling very tired, mood changes, not hungry, or weight loss.
• Signs of Cushing's disease like weight gain in the upper back or belly, moon face, very bad headache, or slow healing.
• Skin changes (pimples, stretch marks, slow healing, hair growth).
• Skin irritation.

• Store at room temperature. Do not freeze.
• Protect from heat.
• Throw away any part not used after 2 months.
• Keep all drugs in a safe place. Keep all drugs out of the reach of children and pets.
• Check with your pharmacist about how to throw out unused drugs.

Applies to fluocinolone topical: topical application cream, topical application gel/jelly, topical application kit, topical application lotion, topical application oil, topical application ointment, topical application shampoo, topical application solution

Along with its needed effects, fluocinolone topical (the active ingredient contained in Capex) may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur while taking fluocinolone topical:

• Body aches or pain
• congestion
• cough
• dryness or soreness of the throat
• fever
• headache
• hoarseness
• lightening of normal skin color
• lightening of treated areas of dark skin
• sore throat
• stuffy or runny nose
• tender, swollen glands in the neck
• trouble swallowing
• unusual tiredness or weakness
• voice changes

• Acne or pimples
• accumulation of pus
• blistering, crusting, irritation, itching, or reddening of the skin
• burning, itching, and pain in hairy areas, or pus at the root of the hair
• burning and itching of the skin with pinhead-sized red blisters
• change in hearing
• cracked, dry, scaly skin
• diarrhea
• dry skin
• earache or pain in the ear
• ear drainage
• flushing or redness of the skin
• darkening of the skin
• itching, scaling, severe redness, soreness, or swelling of the skin
• itchy, raised, round, smooth, skin-colored bumps found on just one area of the body
• ooze thick white fluid
• raised, dark red, wart-like spots on skin, especially when used on the face
• redness or swelling in the ear
• skin irritation
• skin rash, encrusted, scaly and oozing
• spots on your skin resembling a blister or pimple
• swelling
• swollen, red, tender area of infection
• thickened patches of the skin
• vomiting

• Redness and scaling around the mouth
• thinning, weakness, or wasting away of the skin

Some side effects of fluocinolone topical may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

• Changes in skin color
• shiny skin

• increased hair growth on the forehead, back, arms, and legs
• reddish purple lines on the arms, face, legs, trunk, or groin
• softening of the skin

Applies to fluocinolone topical: compounding powder, topical cream, topical kit, topical lotion, topical oil, topical ointment, topical shampoo, topical solution

General

The most commonly reported side effects were erythema, itching, irritation, and burning.[Ref]

Endocrine

Frequency not reported: Hypothalamic-pituitary-adrenal (HPA) axis suppression, Cushing's syndrome[Ref]

Immunologic

Common (1% to 10%): Facial herpes simplex, abscess, molluscum[Ref]

Local

Common (1% to 10%): Telangiectasia, erythema, itching, irritation, burning, hypopigmentation, hyperpigmentation, shiny skin, folliculitis, acneiform eruptions[Ref]

Nervous system

Frequency not reported: Intracranial hypertension (including bulging fontanelles, headaches, bilateral papilledema)

Dermatologic

Common (1% to 10%): Secondary atopic dermatitis, papules and pustules, keratosis pilaris, eczema, rash
Frequency not reported: Hypertrichosis, maceration of the skin, dermatitis, perioral dermatitis, acne or worsening of acne, acne rosacea[Ref]

Metabolic

Frequency not reported: Hyperglycemia, glucosuria[Ref]

Some side effects of Capex may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

Summary of Use during Lactation

Fluocinolone has not been studied during breastfeeding. Since only extensive application of the most potent corticosteroids may cause systemic effects in the mother, it is unlikely that short-term application of topical corticosteroids would pose a risk to the breastfed infant by passage into breastmilk. However, it would be prudent to use the least potent drug on the smallest area of skin possible. It is particularly important to ensure that the infant's skin does not come into direct contact with the areas of skin that have been treated. Only the lower potency corticosteroids should be used on the nipple or areola where the infant could directly ingest the drugs from the skin. Only water-miscible cream or gel products should be applied to the breast because ointments may expose the infant to high levels of mineral paraffins via licking.[1] Any topical corticosteroid should be wiped off thoroughly prior to nursing if it is being applied to the breast or nipple area.

Maternal use of an ear drop that contains ciprofloxacin presents negligible risk for the nursing infant.

Drug Levels

Maternal Levels. Relevant published information was not found as of the revision date.

Infant Levels. Relevant published information was not found as of the revision date.

Effects in Breastfed Infants

Topical application of a corticosteroid with relatively high mineralocorticoid activity (isofluprednone acetate) to the mother's nipples resulted in prolonged QT interval, cushingoid appearance, severe hypertension, decreased growth and electrolyte abnormalities in her 2-month-old breastfed infant. The mother had used the cream since birth for painful nipples.[2]

Effects on Lactation and Breastmilk

Relevant published information was not found as of the revision date.

Alternate Drugs to Consider

(Topical) Hydrocortisone, Topical

References

1. Noti A, Grob K, Biedermann M et al. Exposure of babies to C(15)-C(45) mineral paraffins from human milk and breast salves. Regul Toxicol Pharmacol. 2003;38(3):317-25. PMID: 14623482

2. De Stefano B, Bongo IG, Borgna-Pignatti C et al. Factitious hypertension with mineralocorticoid excess in an infant. Helv Paediatr Acta. 1983;38:185-9. PMID: 6874387

Substance Name

Fluocinolone

CAS Registry Number

807-38-5

Drug Class

Corticosteroids, Topical

Glucocorticoids

Anti-Inflammatory Agents

All possible dosages and drug forms may not be included here. Your dosage, drug form, and how often you take the drug will depend on:

• your age
• the condition being treated
• how severe your condition is
• other medical conditions you have
• how you react to the first dose

What are you taking this medication for?

Brand: Capex

• Apply up to 1 ounce of shampoo to your scalp area once per day

• It has not been confirmed that Capex is safe and effective for use in people younger than 18 years.

Use this drug at the time(s) recommended by your doctor

Store this drug carefully

A prescription for this medication is refillable

Travel

Self-management

Clinical monitoring

Not every pharmacy stocks this drug, so call ahead

Insurance

Are there any alternatives?