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halobetasol propionate
Overview
What is Ultravate?
ULTRAVATE (halobetasol propionate) lotion, 0.05% for topical use contains a corticosteroid, halobetasol propionate. The chemical name of halobetasol propionate is 21-chloro-6α, 9-difluoro-11β, 17-dihydroxy-16β-methylpregna-1, 4-diene-3-20-dione, 17-propionate. Halobetasol propionate is a white to off-white crystalline powder with a molecular weight of 484.96 and a molecular formula of C25H31ClF2O5. It is practically insoluble in water and freely soluble in dichloromethane and in acetone. It has the following structural formula:
Each gram of ULTRAVATE lotion contains 0.5 mg of halobetasol propionate in a white to off-white lotion base consisting of diisopropyl adipate, octyldodecanol, ceteth-20, poloxamer 407, cetyl alcohol, stearyl alcohol, propylparaben, butylparaben, propylene glycol, glycerin, carbomer homopolymer, sodium hydroxide, and water.
What does Ultravate look like?
What are the available doses of Ultravate?
Lotion: 0.05% (0.5 mg/g).
What should I talk to my health care provider before I take Ultravate?
How should I use Ultravate?
ULTRAVATE lotion is a corticosteroid indicated for the topical treatment of plaque psoriasis in patients eighteen (18) years of age and older.
Apply a thin layer of ULTRAVATE lotion to the affected skin twice daily for up to two weeks. Rub in gently.
Discontinue therapy when control is achieved. If no improvement is seen within two weeks, reassessment of diagnosis may be necessary.
Treatment beyond two weeks is not recommended and the total dosage should not exceed 50 grams (50 mL) per week because of the potential for the drug to suppress the hypothalamic-pituitary-adrenal (HPA) axis . Do not use with occlusive dressings unless directed by a physician.
ULTRAVATE lotion is for external use only.
Avoid use on the face, scalp, groin, or axillae.
ULTRAVATE lotion is not for ophthalmic, oral, or intravaginal use.
What interacts with Ultravate?
Sorry No Records found
What are the warnings of Ultravate?
Sorry No Records found
What are the precautions of Ultravate?
Sorry No Records found
What are the side effects of Ultravate?
Sorry No records found
What should I look out for while using Ultravate?
None.
What might happen if I take too much Ultravate?
Topically applied ULTRAVATE lotion can be absorbed in sufficient amounts to produce systemic effects .
How should I store and handle Ultravate?
Storage and HandlingAvoid heat. PANCREAZE capsules should be stored in a dry place in the original container. After opening, KEEP THE CONTAINER TIGHTLY CLOSED between uses to PROTECT FROM MOISTURE. Do not store above 25°C (77°F).The PANCREAZE 2,600 USP units of lipase, the PANCREAZE 4,200 USP units of lipase and the PANCREAZE 21,000 USP units of lipase bottles contain a desiccant canister. eat or throw away the desiccant canister in your medicine bottle. This canister will protect your medicine from moisture.Keep out of reach of children.DO NOT CRUSH PANCREAZE delayed-release capsules or the capsule contents.Storage and HandlingAvoid heat. PANCREAZE capsules should be stored in a dry place in the original container. After opening, KEEP THE CONTAINER TIGHTLY CLOSED between uses to PROTECT FROM MOISTURE. Do not store above 25°C (77°F).The PANCREAZE 2,600 USP units of lipase, the PANCREAZE 4,200 USP units of lipase and the PANCREAZE 21,000 USP units of lipase bottles contain a desiccant canister. eat or throw away the desiccant canister in your medicine bottle. This canister will protect your medicine from moisture.Keep out of reach of children.DO NOT CRUSH PANCREAZE delayed-release capsules or the capsule contents.Storage and HandlingAvoid heat. PANCREAZE capsules should be stored in a dry place in the original container. After opening, KEEP THE CONTAINER TIGHTLY CLOSED between uses to PROTECT FROM MOISTURE. Do not store above 25°C (77°F).The PANCREAZE 2,600 USP units of lipase, the PANCREAZE 4,200 USP units of lipase and the PANCREAZE 21,000 USP units of lipase bottles contain a desiccant canister. eat or throw away the desiccant canister in your medicine bottle. This canister will protect your medicine from moisture.Keep out of reach of children.DO NOT CRUSH PANCREAZE delayed-release capsules or the capsule contents.Storage and HandlingAvoid heat. PANCREAZE capsules should be stored in a dry place in the original container. After opening, KEEP THE CONTAINER TIGHTLY CLOSED between uses to PROTECT FROM MOISTURE. Do not store above 25°C (77°F).The PANCREAZE 2,600 USP units of lipase, the PANCREAZE 4,200 USP units of lipase and the PANCREAZE 21,000 USP units of lipase bottles contain a desiccant canister. eat or throw away the desiccant canister in your medicine bottle. This canister will protect your medicine from moisture.Keep out of reach of children.DO NOT CRUSH PANCREAZE delayed-release capsules or the capsule contents.Storage and HandlingAvoid heat. PANCREAZE capsules should be stored in a dry place in the original container. After opening, KEEP THE CONTAINER TIGHTLY CLOSED between uses to PROTECT FROM MOISTURE. Do not store above 25°C (77°F).The PANCREAZE 2,600 USP units of lipase, the PANCREAZE 4,200 USP units of lipase and the PANCREAZE 21,000 USP units of lipase bottles contain a desiccant canister. eat or throw away the desiccant canister in your medicine bottle. This canister will protect your medicine from moisture.Keep out of reach of children.DO NOT CRUSH PANCREAZE delayed-release capsules or the capsule contents.ULTRAVATE lotion, 0.05 % is white to off-white lotion. It is supplied in an oval tapered white high-density polyethylene bottle with a white polypropylene disc cap. Each bottle contains 60 mL (59 g) of ULTRAVATE lotion.NDC 10631-122-04 60 mL (59g) bottleStore at 25°C (77°F); excursions permitted to 15ºC and 30ºC (59ºF to 86ºF) [see USP Controlled Room Temperature]. Do not freeze.ULTRAVATE lotion, 0.05 % is white to off-white lotion. It is supplied in an oval tapered white high-density polyethylene bottle with a white polypropylene disc cap. Each bottle contains 60 mL (59 g) of ULTRAVATE lotion.NDC 10631-122-04 60 mL (59g) bottleStore at 25°C (77°F); excursions permitted to 15ºC and 30ºC (59ºF to 86ºF) [see USP Controlled Room Temperature]. Do not freeze.ULTRAVATE lotion, 0.05 % is white to off-white lotion. It is supplied in an oval tapered white high-density polyethylene bottle with a white polypropylene disc cap. Each bottle contains 60 mL (59 g) of ULTRAVATE lotion.NDC 10631-122-04 60 mL (59g) bottleStore at 25°C (77°F); excursions permitted to 15ºC and 30ºC (59ºF to 86ºF) [see USP Controlled Room Temperature]. Do not freeze.
Clinical Information
Chemical Structure
No Image foundClinical Pharmacology
Corticosteroids play a role in cellular signaling, immune function, inflammation, and protein regulation; however, the precise mechanism of action in plaque psoriasis is unknown.
Non-Clinical Toxicology
None.The risk of using Parlodel in combination with other drugs has not been systematically evaluated, but alcohol may potentiate the side effects of Parlodel. Parlodel may interact with dopamine antagonists, butyrophenones, and certain other agents. Compounds in these categories result in a decreased efficacy of Parlodel: phenothiazines, haloperidol, metoclopramide, and pimozide. Bromocriptine is a substrate of CYP3A4. Caution should therefore be used when co-administering drugs which are strong inhibitors of this enzyme (such as azole antimycotics, HIV protease inhibitors). The concomitant use of macrolide antibiotics such as erythromycin was shown to increase the plasma levels of bromocriptine (mean AUC and C values increased 3.7-fold and 4.6-fold, respectively). The concomitant treatment of acromegalic patients with bromocriptine and octreotide led to increased plasma levels of bromocriptine (bromocriptine AUC increased about 38%).Concomitant use of Parlodel with other ergot alkaloids is not recommended. Dose adjustment may be necessary in those cases where high doses of bromocriptine are being used (such as Parkinson’s disease indication).
ULTRAVATE lotion is a topical corticosteroid that has been shown to suppress the hypothalamic-pituitary-adrenal (HPA) axis.
Systemic effects of topical corticosteroids may include reversible HPA axis suppression, with the potential for glucocorticosteroid insufficiency. This may occur during treatment or upon withdrawal of treatment of the topical corticosteroid.
The potential for hypothalamic-pituitary adrenal (HPA) suppression with ULTRAVATE lotion was evaluated in a study of 20 adult subjects with moderate to severe plaque psoriasis involving ≥20% of their body surface area. ULTRAVATE lotion produced HPA axis suppression when used twice daily for two weeks in 5 out of 20 (25%) adult patients with plaque psoriasis. Recovery of HPA axis function was generally prompt with the discontinuation of treatment.
Because of the potential for systemic absorption, use of topical corticosteroids, including ULTRAVATE lotion, may require that patients be evaluated periodically for evidence of HPA axis suppression. Factors that predispose a patient using a topical corticosteroid to HPA axis suppression include the use of more potent corticosteroids, use over large surface areas, prolonged use, occlusive use, use on an altered skin barrier, concomitant use of multiple corticosteroid-containing products, liver failure, and young age. An ACTH stimulation test may be helpful in evaluating patients for HPA axis suppression.
If HPA axis suppression is documented, attempt to gradually withdraw the drug, reduce the frequency of application, or substitute a less potent steroid. Manifestations of adrenal insufficiency may require supplemental systemic corticosteroids. Recovery of HPA axis function is generally prompt and complete upon discontinuation of topical corticosteroids.
Systemic effects of topical corticosteroids may also include Cushing's syndrome, hyperglycemia, and glucosuria. Use of more than one corticosteroid-containing product at the same time may increase the total systemic exposure to topical corticosteroids.
Pediatric patients may be more susceptible than adults to systemic toxicity from the use of topical corticosteroids due to their larger surface-to-body mass ratios .
Reference
This information is obtained from the National Institute of Health's Standard Packaging Label drug database.
"https://dailymed.nlm.nih.gov/dailymed/"
While we update our database periodically, we cannot guarantee it is always updated to the latest version.
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