Clobetasol Propionate (Clobex)

Trade Name : Clobex

Galderma Laboratories, L.P.

SHAMPOO

Strength 0.05 g/100mL

CLOBETASOL PROPIONATE Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA]

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Trade Marks displayed in compliance with provisions of: Trademark Act, 1999 u/s 30 and 30 (1) of "Fair use"

GNH India is WHO GDP and ISO 9001 2015 Certified Pharmaceutical Wholesaler/ Supplier/ Exporters/ Importer from India of Clobetasol Propionate (Clobex) which is also known as Clobex and Manufactured by Galderma Laboratories, L.P.. It is available in strength of 0.05 g/100mL per ml. Read more

Clobetasol Propionate (Clobex) is supplied for Tenders/ Emergency imports/ Un - licensed, Specials, Orphan drug/ Name patient line/ RLD supplies/ Reference listed drugs/ Comparator Drug/ Bio-Similar/ Innovator samples For Clinical trials. Click to know price. Read less

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No data

CLOBEX (clobetasol propionate) Shampoo, 0.05% is a corticosteroid indicated for the treatment of moderate to severe scalp psoriasis in subjects 18 years of age and older. () Limitations of Use:

Do not use on the face, axillae or groin. ()
Avoid any contact with the eyes and lips. ()

CLOBEX Shampoo, 0.05% is for topical use only, and not for ophthalmic, oral or intravaginal use.n CLOBEX Shampoo, 0.05%, should be applied onto dry (not wet) scalp once a day in a thin film to the affected areas only, and left in place for 15 minutes before lathering and rinsing. n The total dosage should not exceed 50 g (50 mL or 1.75 fl. oz.) per week. n Move the hair away from the scalp so that one of the affected areas is exposed. Position the bottle over the lesion. Apply a small amount of the shampoo directly onto the lesion, letting the product naturally flow from the bottle (gently squeeze the bottle), avoiding any contact of the product with the facial skin, eyes or lips. In case of contact, rinse thoroughly with water. Spread the product so that the entire lesion is covered with a thin uniform film. Massage gently into the lesion and repeat for additional lesion(s). Wash your hands after applying CLOBEX Shampoo, 0.05%.n Leave the shampoo in place for 15 minutes, then add water, lather and rinse thoroughly all parts of the scalp and body that came in contact with the shampoo (e.g., hands, face, neck and shoulders). Avoid contact with eyes and lips. Minimize contact to non-affected areas of the body. Although no additional shampoo is necessary to cleanse your hair, you may use a non-medicated shampoo if desired.n Treatment should be limited to 4 consecutive weeks. As with other corticosteroids, therapy should be discontinued when control is achieved. If complete disease control is not achieved after 4 weeks of treatment with CLOBEX Shampoo, 0.05%, treatment with a less potent topical steroid may be substituted. If no improvement is seen within 4 weeks, reassessment of the diagnosis may be necessary.n CLOBEX Shampoo, 0.05%, should not be used with occlusive dressings (shower cap or bathing cap) unless directed by a physician.

Not for oral, ophthalmic, or intravaginal use. ()
CLOBEX Shampoo, 0.05% should be applied onto dry (not wet) scalp once a day in a thin film to the affected areas only, and left in place for 15 minutes before lathering and rinsing. CLOBEX Shampoo, 0.05% contains a super-high potent topical corticosteroid; therefore treatment should be limited to 4 weeks. ()
As with other corticosteroids, therapy should be discontinued when control is achieved. ()
Total dosage should not exceed 50 g (50mL or 1.75 fl. oz.) per week. ()
CLOBEX Shampoo should not be used with a shower cap or bathing cap. ()

Shampoo, 0.05%, w/w. Each gram of CLOBEX Shampoo, 0.05%, contains 0.5 mg of clobetasol propionate in a translucent, colorless to pale yellow viscous liquid.
Shampoo, 0.05% ()

None
None ()

Clobetasol propionate is a highly potent topical corticosteroid that has been shown to suppress the hypothalamic-pituitary-adrenal (HPA) axis at the lowest doses tested. ()n Cushingu2019s syndrome, hyperglycemia and unmasking of latent diabetes mellitus can also result from systemic absorption of topical corticosteroids. () n Systemic absorption may require periodic evaluation for HPA axis suppression. Modify use if HPA axis suppression develops. ()n Children may be more susceptible to systemic toxicity from use of topical corticosteroids. (, )n If irritation develops in the presence of dermatological infections, the use of an appropriate antifungal or antibacterial agent should be instituted. If a favorable response does not occur promptly, use of CLOBEX Shampoo should be discontinued until the infection has been adequately controlled. ()n Local adverse reactions with topical corticosteroids may occur more frequently with the use of occlusive dressings and higher potency corticosteroids, including clobetasol propionate. These reactions include: folliculitis, acneiform eruptions, hypopigmentation, perioral dermatitis, allergic contact dermatitis, secondary infection, striae and miliaria. ()

The most common adverse reactions are burning/stinging, pruritus, edema, folliculitis, acne, dry skin, irritant dermatitis, alopecia, urticaria, skin atrophy and telangiectasia. ()n n n

No data

Topically applied, CLOBEX Shampoo, 0.05%, can be absorbed in sufficient amounts to produce systemic effects [].

CLOBEX (clobetasol propionate) Shampoo, 0.05%, 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. The chemical name of clobetasol propionate is 21-chloro-9-fluoro-11u03b2, 17-dihydroxy-16u03b2-methylpregna-1, 4-diene-3, 20-dione 17-propionate.
It has the following structural formula:
Clobetasol propionate has a molecular weight of 466.97 (CAS Registry Number 25122-46-7). The molecular formula is CHCIFO. Clobetasol propionate is a white to practically white crystalline, odorless powder insoluble in water.n Each gram of CLOBEX (clobetasol propionate) Shampoo, 0.05%, contains 0.5 mg of clobetasol propionate in a translucent, colorless to pale yellow viscous liquid shampoo base consisting of alcohol, citric acid, coco-betaine, polyquaternium-10, purified water, sodium citrate, and sodium laureth sulfate.

No data

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 u00b5g/kg/day (ratio of animal dose to proposed human dose of 0.03 on a mg/m/day basis). n 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.n Clobetasol propionate was negative in the mammalian chromosomal aberration test and in the mammalian erythrocyte micronucleus test. n 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 u00b5g/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 u00b5g/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 u00b5g/kg/day (ratio of animal dose to proposed human dose of 0.03 on a mg/m/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.

The safety and efficacy of CLOBEX Shampoo, 0.05%, have been evaluated in two clinical trials involving 290 subjects with moderate to severe scalp psoriasis. In both trials, subjects were treated with either CLOBEX Shampoo or the corresponding vehicle applied once daily for 15 minutes before lathering and rinsing for a period of 4 weeks. Efficacy results are presented in Table 2 below.

CLOBEX Shampoo, 0.05%, is a translucent, colorless to pale yellow viscous liquid, supplied in 4 fl. oz. (118 mL) bottles.
NDCn- Storage:

See FDA-approved patient labeling (Patient Information)
Information for Patients

Patient Informationn- Arrayn- (clobetasol propionate)n- Shampoon- Important:n- What is CLOBEX Shampoo?
You should not use CLOBEX Shampoo:
What should I tell my doctor before using CLOBEX Shampoo?n- Before you use CLOBEX Shampoo, tell your doctor if you:
Talk to your doctor about the best way to feed your baby if you use CLOBEX Shampoo.
Tell your doctor about all the medicines you take,n- How should I use CLOBEX Shampoo?
See the u201cInstructions for Useu201d at the end of the Patient Information for detailed information about the right way to use CLOBEX Shampoo.n n n n Too much CLOBEX Shampoo 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. n n n
How should I store CLOBEX Shampoo?
Keep CLOBEX Shampoo and all medicines out of the reach of children.n- General information about CLOBEX Shampoon- What are the ingredients in CLOBEX Shampoo?n- Instructions for Usen- CLOBEXu00ae (KLO-bex)n- (clobetasol propionate)n- Shampoo
Important:
How to apply CLOBEX Shampoo to your scalp:n- Your hair should be dry when you apply CLOBEX Shampoo to your scalp.n- Do not get CLOBEX Shampoo on your face, in your eyes or on your lips.n- Arrayn- Arrayn- : Leave CLOBEX Shampoo on your scalp for 15 minutes. You should not bandage or cover your head with a shower cap, bathing cap, or a towel
GALDERMA is a registered trademark.US Patent Nos. 7,316,810 and 7,700,081

Rx Only
NDC
Clobex (clobetasol propionate)
SHAMPOO
0.05%
4 FL OZ
(118 mL)
GALDERMA
For External Use Only.
Not for Ophthalmic Use.
Usual dosage:
Apply a thin film to affected areas of the scalp once daily; apply on dry scalp and leave in place for 15 minutes before lathering and rinsing. Do not apply CLOBEX (clobetasol propionate) Shampoo, 0.05% to the face, underarms or groin, and avoid contact with eyes and lips. Do not use for longer than 4 weeks. See package insert for complete prescribing information.See carton closure for lot number and expiration date.n
Each mL contains:n- Active ingredient:
Excipients:
Storage:
Marketed by:
GALDERMA LABORATORIES, L.P.
Fort Worth, Texas 76177 USAn All trademarks are the property of their respective owners.n P51351-2n n

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Clobetasol Propionate (Clobex)

Trade Name : Clobex

SHAMPOO

Delivery Process

Product information is meant for

Disclaimer

Trade Marks displayed in compliance with provisions of: Trademark Act, 1999 u/s 30 and 30 (1) of "Fair use"

Packaging and Delivery

About GNH

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Clobetasol Propionate (Clobex)

Trade Name : Clobex

SHAMPOO

Delivery Process

Product information is meant for

Disclaimer

Trade Marks displayed in compliance with provisions of: Trademark Act, 1999 u/s 30 and 30 (1) of "Fair use"

Packaging and Delivery

About GNH

Similar Products

Desogestrel And Ethinyl Estradiol (Emoquette)

Diphenoxylate Hydrochloride And Atropine Sulfate (Diphenoxylate Hydrochloride And Atropine Sulfate)

Fluoxetine Hydrochloride (Fluoxetine)

Metoprolol Succinate (Metoprolol Succinate)

Losartan Potassium (Losartan Potassium)

Browse Our Services And Processes

Disclaimer

Browse from other international pharmaceuticals

General

US NDC

Canadian DIN

Swiss Drugs

NZ Drugs

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