Impeklo

Generic name: clobetasol propionate
Dosage form: topical lotion
Drug class: Topical steroids

Medically reviewed by A Ras MD.

What is Impeklo?

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

Impeklo lotion should not be used for the treatment of acne vulgaris, rosacea or red, dry itchy skin (dermatitis) around the mouth.

Impeklo lotion is not recommended in children under 18 years of age.

Description

IMPEKLO (clobetasol propionate) lotion contains clobetasol propionate, a synthetic fluorinated corticosteroid, for topical use. The corticosteroids constitute a class of primarily synthetic steroids used topically as anti-inflammatory and antipruritic agents. Clobetasol propionate is 21-chloro-9-fluoro-11β, 17-dihydroxy-16β -methylpregna-1,4-diene-3,20-dione 17-propionate, with the empirical formula C25H32CIFO5, and a molecular weight of 466.97 (CAS Registry Number 25122-46-7).

The following is the chemical structure:

Clobetasol Propionate Structural Formula

Clobetasol propionate

Clobetasol propionate, USP is a white to almost white crystalline powder that is practically insoluble in water. IMPEKLO (clobetasol propionate) lotion is a white to off white, opaque to translucent, homogenous and lump free lotion composed of carbomer 1342, hypromellose, mineral oil, PEG-6 isostearate, propylene glycol, purified water and sodium hydroxide. Each pump actuation delivers 0.15 mg of clobetasol propionate in 0.30 g of lotion.

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.

What is the most important information I should know about Impeklo?

Impeklo lotion is for use on the skin only. Do not get Impeklo lotion near or in your eyes, mouth or vagina.

What should I tell my healthcare provider before using Impeklo?

Before you use Impeklo lotion, tell your healthcare provider about all of your medical conditions, including if you:

have had irritation or other skin reactions to a steroid medicine in the past.
have a skin infection. You may need medicine to treat the skin infection before using Impeklo lotion.
have diabetes.
have adrenal gland problems.
have liver problems.
plan to have surgery.
are pregnant or plan to become pregnant. It is not known if Impeklo lotion can harm your unborn baby. If you use Impeklo lotion during pregnancy, use Impeklo lotion on the smallest area of skin and for the shortest time needed.
are breastfeeding or plan to breastfeed. It is not known if Impeklo lotion passes into your breast milk. If you use Impeklo lotion while breastfeeding, use Impeklo lotion on the smallest area of skin and for the shortest time needed. Do not apply Impeklo lotion directly to the nipple and areola to avoid getting Impeklo lotion into your baby’s mouth.

Tell your healthcare provider about all the medicines you take, including prescription or over-the-counter medicines, vitamins, and herbal supplements. Do not use other products containing corticosteroid medicine during treatment with Impeklo lotion without talking to your healthcare provider first.

How should I use Impeklo?

See the instructions for use that comes with Impeklo lotion for detailed information about the right way to apply Impeklo lotion.

Use Impeklo lotion exactly as your healthcare provider tells you to use it.
Apply Impeklo lotion 2 times each day to the affected skin areas and rub in gently and completely.
You should not use Impeklo lotion on your face, underarms (armpits), groin, or in areas with thinning skin (atrophy).
Do not bandage, cover or wrap your treated area unless your healthcare provider tells you to.
Do not use more than 50 grams of Impeklo lotion in 7 days. Do not use more than 10 pumps of Impeklo lotion at one time twice daily or 20 pumps per day for more than 7 days.
Talk to your healthcare provider if your skin does not improve after 2 weeks of treatment with Impeklo lotion.
Wash your hands after using Impeklo lotion.

What are the possible side effects of Impeklo?

Impeklo lotion may cause serious side effects, including:

Impeklo lotion can pass through your skin. Too much Impeklo lotion passing through your skin can cause your adrenal glands to stop working.
Cushing’s syndrome, a condition that happens when the body is exposed to too much of the hormone cortisol.
High blood sugar (hyperglycemia).
Vision problems. Impeklo lotion may increase your chance of developing vision problems such as cataract(s) and glaucoma. Tell your healthcare provider if you develop blurred vision or other vision problems during treatment with Impeklo lotion.
Skin reactions at the treated skin site. Tell your healthcare provider if you get any skin reactions or skin infections.
Effects on growth and weight in children.

The most common side effects of Impeklo lotion include thinning of the skin (atrophy), widening of small veins in the skin, skin discomfort and skin dryness.

These are not all of the possible side effects of Impeklo lotion.
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

General information about the safe and effective use of Impeklo

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

How should I store Impeklo?

Store Impeklo lotion at room temperature between 68°F to 77°F (20°C to 25°C).
Do not freeze Impeklo lotion.

Keep Impeklo lotion and all medicines out of reach of children.

What are the ingredients in Impeklo?

Active ingredient: clobetasol propionate

Inactive ingredients: carbomer 1342, hypromellose, mineral oil, PEG-6 isostearate, propylene glycol, purified water and sodium hydroxide.

Label

PRINCIPAL DISPLAY PANEL – 0.05%

NDC 49502-537-35 Rx only
Impeklo™
Clobetasol Propionate Lotion
0.05% Metered-Dose Pump
0.15 mg of clobetasol
propionate per
pump actuation*
*Each actuation delivers 0.30 g of lotion
Metered-dose pump
capable of dispensing
not less than
138 actuations to
deliver not less than
41.4 g of lotion.
Topical Lotion
For external use only.
Not for eye use.
68 g

	Remove the large cap
	Remove the small cap around the tip of the pump
	Turn the pump counter clockwise from the “lock” () position to the “unlock” () position