Clobetasol Propionate (Page 3 of 3)

12.3 Pharmacokinetics

The extent of percutaneous absorption of topical corticosteroids is determined by many factors, including the vehicle, the integrity of the epidermal barrier and occlusion.

Topical corticosteroids can be absorbed from normal intact skin. Inflammation and other disease processes in the skin may increase percutaneous absorption.

There are no human data regarding the distribution of corticosteroids to body organs following topical application. Nevertheless, once absorbed through the skin, topical corticosteroids are handled through metabolic pathways similar to systemically administered corticosteroids. They are metabolized, primarily in the liver, and are then excreted by the kidneys. In addition, some corticosteroids and their metabolites are also excreted in the bile.

13 NONCLINICAL TOXICOLOGY

13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility

Clobetasol propionate was not carcinogenic to rats when topically applied for 2 years at concentrations up to 0.005% which corresponded to doses up to 11 mcg/kg/day (ratio of animal dose to proposed human dose of 0.03 on a mg/m2 /day basis).

Clobetasol propionate at concentrations up to 0.001% did not increase the rate of formation of ultra violet light-induced skin tumors when topically applied to hairless mice 5 days per week for a period of 40 weeks.

Clobetasol propionate was negative in the in vitro mammalian chromosomal aberration test and in the in vivo mammalian erythrocyte micronucleus test.

The effect of subcutaneously administered clobetasol propionate on fertility and general reproductive toxicity was studied in rats at doses of 0, 12.5, 25, and 50 mcg/kg/day. Males were treated beginning 70 days before mating and females beginning 15 days before mating through day 7 of gestation. A dosage level of less than 12.5 mcg/kg/day clobetasol propionate was considered to be the no-observed-effect-level (NOEL) for paternal and maternal general toxicity based on decreased weight gain and for male reproductive toxicity based on increased weights of the seminal vesicles. The female reproductive NOEL was 12.5 mcg/kg/day (ratio of animal dose to proposed human dose of 0.03 on a mg/m2 /day basis) based on reduction in the numbers of estrous cycles during the pre-cohabitation period and an increase in the number of nonviable embryos at higher doses.

14 CLINICAL STUDIES

The efficacy of clobetasol propionate lotion, 0.05% in psoriasis and atopic dermatitis has been demonstrated in two adequate and well-controlled clinical trials. The first trial was conducted in subjects with moderate to severe plaque psoriasis. Subjects were treated twice daily for 4 weeks with either clobetasol propionate lotion, 0.05% or vehicle lotion. Trial results demonstrated that the efficacy of clobetasol propionate lotion, 0.05% in treating moderate to severe plaque psoriasis was superior to that of vehicle.

At the end of treatment (4 weeks), 30 of 82 subjects (36.6%) treated with clobetasol propionate lotion, 0.05% compared with 0 of 29 (0%) treated with vehicle achieved success. Success was defined as a score of none or very mild (no or very slight clinical signs or symptoms of erythema, plaque elevation, or scaling) on the Global Severity scale of psoriasis.

The second trial was conducted in subjects with moderate to severe atopic dermatitis. Subjects were treated twice daily for 2 weeks with either clobetasol propionate lotion, 0.05% or vehicle lotion. Trial results demonstrated that the efficacy of clobetasol propionate lotion, 0.05% in treating moderate to severe atopic dermatitis was superior to that of vehicle.

At the end of treatment (2 weeks), 41 of 96 subjects (42.7%) treated with clobetasol propionate lotion, 0.05% compared with 4 of 33 (12.1%) treated with vehicle achieved success. Success was defined as a score of none or very mild (no or very slight clinical signs or symptoms of erythema, induration/papulation, oozing/crusting, or pruritus) on the Global Severity scale of atopic dermatitis.

16 HOW SUPPLIED/STORAGE AND HANDLING

Clobetasol propionate lotion, 0.05% is a white to off white, opaque to translucent lotion, supplied in the following sizes:

2 fl oz/59 mL NDC 68180-536-01 high density polyethylene bottles

4 fl oz/118 mL NDC 68180-536-02 high density polyethylene bottles

Store at 25°C (77°F): excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature]. Protect from freezing.

17 PATIENT COUNSELING INFORMATION

See FDA-approved patient labeling (Patient Information)

Information for Patients

Inform the patient using topical corticosteroids to adhere to the following instructions:

  • This medication is to be used as directed by the physician and should not be used longer than the prescribed time period.
  • This medication should not be used for any disorder other than that for which it was prescribed.
  • Do not use other corticosteroid-containing products while using clobetasol propionate lotion, 0.05%.
  • The treated skin area should not be bandaged, otherwise covered, or wrapped so as to be occlusive unless directed by the physician.
  • Patients should wash their hands after applying the medication.
  • Patients should report any signs of local or systemic adverse reactions to the physician.
  • Patients should inform their physicians that they are using clobetasol propionate lotion, 0.05% if surgery is contemplated.
  • This medication is for external use only. It should not be used on the face, underarms, or groin area, and avoid contact with the eyes and lips.
  • As with other corticosteroids, therapy should be discontinued when control is achieved. If no improvement is seen within 2 weeks, contact the physician.
  • Patients should be informed to not use more than 50 g (50 mL or 1.75 fl. oz.) per week of clobetasol propionate lotion, 0.05%.

® The brands listed are trademarks of their respective owners and are not trademarks of Lupin Pharmaceuticals, Inc. The makers of these brands are not affiliated with and do not endorse Lupin Pharmaceuticals, Inc. or its products.

Manufactured for:

Lupin Pharmaceuticals, Inc.

Baltimore, Maryland 21202

United States

Manufactured by:

Lupin Limited

Pithampur (M.P.) — 454 775

India

October 2017 ID#: 253521

Patient Information

Clobetasol Propionate Lotion

(kloe bay′ ta sol proe′ pee oh nate)

Important: For use on skin only. Do not get clobetasol propionate lotion near or in your eyes, mouth or vagina.

Read the Patient Information that comes with clobetasol propionate lotion before you start using it and each time you get a refill. There may be new information. This information does not take the place of talking with your doctor about your medical condition or your treatment.

What is Clobetasol Propionate Lotion?

Clobetasol propionate lotion is a prescription corticosteroid medicine used to reduce the swelling (inflammation) and itching caused by certain skin conditions called corticosteroid-responsive dermatoses, including atopic dermatitis and psoriasis, in people 18 years of age and older. Clobetasol propionate lotion is for use on the skin only (topical).

  • Clobetasol propionate lotion should only be used for the shortest amount of time needed to treat your skin condition.
  • Clobetasol propionate lotion should not be used for more than 2 weeks in a row unless your doctor tells you to use it for a longer time.
  • You should not apply more than 50 mL (1.75 fluid ounces) of clobetasol propionate lotion to your skin in 1 week.

You should not use Clobetasol Propionate Lotion:

  • on your face, underarms (armpits), or groin areas
  • if you have thinning of the skin (atrophy) at the treatment site
  • to treat rosacea or a rash around your mouth (perioral dermatitis)

Clobetasol propionate lotion should not be used in children under 18 years of age.

What should I tell my doctor before using Clobetasol Propionate Lotion?

Before you use Clobetasol Propionate Lotion, tell your doctor if you:

  • have a skin infection. You may need medicine to treat the skin infection before you use clobetasol propionate lotion.
  • have any open sores or cuts on your skin
  • plan to have surgery
  • have any other medical conditions
  • are pregnant or plan to become pregnant. It is not known if clobetasol propionate lotion can harm your unborn baby.
  • are breast-feeding or plan to breast-feed. It is not known if clobetasol propionate lotion passes into your breast milk. Talk to your doctor about the best way to feed your baby if you use clobetasol propionate lotion.

Tell your doctor about all the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements. Especially tell your doctor if you take other corticosteroid medicines by mouth or use other products on your skin that contain corticosteroids. You should not use other products that contain corticosteroids while you are using clobetasol propionate lotion. Ask your doctor or pharmacist if you are not sure.

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

How should I use Clobetasol Propionate Lotion?

  • Use clobetasol propionate lotion exactly as your doctor tells you to use it.
  • Your doctor should tell you how much clobetasol propionate lotion to use and where to apply it.
  • Clobetasol propionate lotion is for skin use only (topical).
  • You should not use clobetasol propionate lotion on your face, underarms or groin. Avoid getting clobetasol propionate lotion in your eyes or on your lips.
  • Apply clobetasol propionate lotion 2 times each day.
  • Apply only enough clobetasol propionate lotion to cover your affected skin areas.

To apply Clobetasol Propionate Lotion:

  • Turn the bottle of clobetasol propionate lotion upside down.
  • Apply clobetasol propionate lotion onto your fingertips or directly on your affected skin area.
  • Rub clobetasol propionate lotion into your affected skin area gently and completely.
  • Repeat these steps to apply clobetasol propionate lotion to all affected skin areas as your doctor tells you.
  • Wash your hands after applying clobetasol propionate lotion.
  • Do not bandage, cover or wrap your treated areas unless your doctor tells you to.
  • Tell your doctor if your skin condition is not getting better after using clobetasol propionate lotion for 2 weeks in a row. Do not use clobetasol propionate lotion for more than 2 weeks unless your doctor tells you to.

What are the possible side effects of Clobetasol Propionate Lotion?

Clobetasol propionate lotion can pass through your skin. Too much clobetasol propionate lotion passing through your skin can cause your adrenal glands to stop working. Your doctor may do blood tests to check how well your adrenal glands are working.

The most common side effects of Clobetasol Propionate Lotion include:

  • burning, stinging, itching, redness, irritation and dry skin
  • thinning of the skin
  • widening of small blood vessels in the skin
  • skin discomfort at the site of application

If you go to another doctor for illness, injury or surgery tell your doctor that you are using clobetasol propionate lotion.

Tell your doctor if you have any side effect that bothers you or that does not go away.

These are not all the possible side effects of clobetasol propionate lotion. For more information, ask your doctor or pharmacist.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

You may also report side effects to Lupin Pharmaceuticals, Inc. at 1-800-399-2561 or visit our website at www.lupinpharmaceuticals.com.

How should I store Clobetasol Propionate Lotion?

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

Keep clobetasol propionate lotion and all medicines out of reach of children.

General information about Clobetasol Propionate Lotion.

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

This Patient Information leaflet summarizes the most important information about clobetasol propionate lotion. If you would like more information, talk with your doctor. You can ask your pharmacist or doctor for information about clobetasol propionate lotion that is written for health professionals.

What are the ingredients in Clobetasol Propionate Lotion?

Active ingredient: clobetasol propionate

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

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

Manufactured for:

Lupin Pharmaceuticals, Inc.

Baltimore, Maryland 21202

United States

Manufactured by:

Lupin Limited

Pithampur (M.P.) — 454 775

India

October 2017 ID#: 253522

Clobetasol Propionate Lotion, 0.05%

59 mL Bottle

NDC 68180- 536-01

Rx only

FOR EXTERNAL USE ONLY.

Nor for Eye Use.

container label
(click image for full-size original)

Clobetasol Propionate Lotion, 0.05%

59 mL Carton

NDC 68180- 536-01

Rx only

FOR EXTERNAL USE ONLY.

Nor for Eye Use.

carton label
(click image for full-size original)
CLOBETASOL PROPIONATE
clobetasol propionate lotion
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:68180-536
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CLOBETASOL PROPIONATE (CLOBETASOL) CLOBETASOL PROPIONATE 0.05 g in 100 mL
Inactive Ingredients
Ingredient Name Strength
CARBOMER 1342
HYPROMELLOSES
MINERAL OIL
PEG-6 ISOSTEARATE
PROPYLENE GLYCOL
WATER
SODIUM HYDROXIDE
Product Characteristics
Color WHITE (white to off white, opaque to translucent) Score
Shape Size
Flavor Imprint Code
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:68180-536-01 1 BOTTLE in 1 CARTON contains a BOTTLE
1 59 mL in 1 BOTTLE This package is contained within the CARTON (68180-536-01)
2 NDC:68180-536-02 1 BOTTLE in 1 CARTON contains a BOTTLE
2 118 mL in 1 BOTTLE This package is contained within the CARTON (68180-536-02)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA209147 01/30/2018
Labeler — Lupin Pharmaceuticals, Inc. (089153071)
Registrant — LUPIN LIMITED (675923163)
Establishment
Name Address ID/FEI Operations
LUPIN LIMITED 650595213 MANUFACTURE (68180-536), PACK (68180-536)

Revised: 12/2020 Lupin Pharmaceuticals, Inc.

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