Ketoconazole (Xolegel)

Trade Name : Xolegel

Almirall, LLC

GEL

Strength 20 mg/g

KETOCONAZOLE Azole Antifungal [EPC],Azoles [CS],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 3A5 Inhibitors [MoA],P-Glycoprotein Inhibitors [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 Ketoconazole (Xolegel) which is also known as Xolegel and Manufactured by Almirall, LLC. It is available in strength of 20 mg/g per ml. Read more

Ketoconazole (Xolegel) 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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We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

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About GNH

No data

XOLEGEL is indicated for the topical treatment of seborrheic dermatitis in immunocompetent adults and children 12 years of age and older.
Safety and efficacy of XOLEGEL for treatment of fungal infections have not been established.

XOLEGEL is an azole antifungal indicated for topical treatment of seborrheic dermatitis in immunocompetent adults and children 12 years of age and older. (,)
Safety and efficacy of XOLEGEL for treatment of fungal infections have not been established. ()

XOLEGEL is for topical use only, and not for oral, ophthalmic, or intravaginal use.
XOLEGEL should be applied once daily to the affected area for 2 weeks.

XOLEGEL is for topical use only, and not for oral, ophthalmic, or intravaginal use. ()
XOLEGEL should be applied once daily to the affected area for 2 weeks. ()

XOLEGEL is a translucent to clear amber colored gel containing 2% ketoconazole.

Gel containing 2% ketoconazole. ()

None.

None.

XOLEGEL is flammable. Avoid using near fire, flame, or smoking during and immediately following application of XOLEGEL. ()

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice.
In the 3 safety and efficacy trials, 65 of 933 subjects (7%) experienced at least one treatment-related adverse event. The most common treatment-related adverse reaction was application site burning (4%). Treatment-related application site reactions that were reported in < 1% of subjects were: dermatitis, discharge, dryness, erythema, irritation, pain, pruritus, and pustules. Other treatment-related adverse reactions that were reported in < 1% of subjects were: eye irritation, eye swelling, keratoconjunctivitis sicca, impetigo, pyogenic granuloma, dizziness, headache, paresthesia, acne, nail discoloration, facial swelling.
To report SUSPECTED ADVERSE REACTIONS, contact Almirall at 1-866-665-2782 or FDA at 1-800-FDA-1088 or .

The most common treatment-related adverse reaction was application site burning (4%). ()

Formal drug interaction studies with XOLEGEL have not been performed. Coadministration of oral ketoconazole with CYP3A4 metabolized HMG-CoA reductase inhibitors such as simvastatin, lovastatin and atorvastatin, may increase the risk of skeletal muscle toxicity, including rhabdomyolysis. These effects have not been observed with topically administered ketoconazole.

No data

XOLEGEL contains the antifungal agent ketoconazole USP at 2% in a topical anhydrous gel vehicle for topical administration.
Chemically, ketoconazole is (u00b1)-cis-1-Acetyl-4-[p-[[2-(2,4-dichlorophenyl)-2-(1H-imidazol-1-ylmethyl)-1,3-dioxolan-4-yl]methoxy]phenyl]piperazine, with the molecular formula CHClNO and a molecular weight of 531.43.
Figure 1
Each gram contains: 20 mg ketoconazole USP, dehydrated alcohol (34%), ascorbic acid, butylated hydroxytoluene, citric acid monohydrate, glycerin, hydroxypropyl cellulose, polyethylene glycol 400, PPG-15 stearyl ether, propylene glycol, FD&C yellow No. 6, and FD&C yellow No. 10.
XOLEGEL is a smooth, translucent to clear, amber gel.

No data

A 2-year dermal carcinogenicity study conducted in mice with topical administration of ketoconazole gel at doses up to 80 mg ketoconazole/kg/day exhibited no evidence of carcinogenic activity. A long-term feeding study in mice and in rats showed no evidence of carcinogenic activity.
Ketoconazole produced no evidence of mutagenicity in the dominant lethal mutation test in male and female mice at single oral doses up to 80 mg/kg. When tested in the Ames assay, ketoconazole was not mutagenic to in the presence or absence of metabolic activation. Ketoconazole, in combination with another drug, gave equivocal results in the mouse micronucleus test.
At oral doses of 75 mg/kg/day, ketoconazole impaired the reproductive performance in female (decreased pregnancy and implantation rates) and male (increased abnormal sperm and decreased sperm motility) rats.

Study 1 was a multicenter, double-blind, randomized, vehicle-controlled trial which enrolled 459 subjects 12 years of age and older with moderate to severe seborrheic dermatitis. A total of 229 subjects were treated with XOLEGEL, and 230 subjects were treated with vehicle. All subjects were treated once daily for 14 days, and efficacy was assessed at Day 28 (i.e., 2 weeks after end of treatment). Effective Treatment was defined as:
The proportion of subjects effectively treated is shown in .
Two additional double-blind, randomized, vehicle-controlled, parallel, and multicenter trials that included a total of 316 subjects treated with XOLEGEL provided supportive evidence of the efficacy of XOLEGEL for treatment of seborrheic dermatitis. Subjects applied either XOLEGEL or vehicle study treatment to the affected area(s) once daily for 14 days and were followed through Day 28. Efficacy was assessed by the proportion of subjects who were completely clear at Day 28.
The contribution to efficacy of individual components of the vehicle has not been established.

No data

[See FDA-Approved Patient Labeling ()]

PATIENT INFORMATION
XOLEGEL (Xol-a-gel)
(ketoconazole) Gel, 2%
Read the Patient Information that comes with XOLEGEL carefully before you start using it and each time you get a refill. There may be new information. This leaflet does not take the place of talking with your health care provider. If you have any questions about XOLEGEL, ask your health care provider.
What is XOLEGEL?
XOLEGEL is a prescription medicine used on the skin to treat a skin condition called seborrheic dermatitis.
Patients with seborrheic dermatitis can have areas of dry, flaky skin on the scalp, face, ears, chest, or upper back. XOLEGEL is only to be used in adults and in children older than 12 years of age who have a normal (healthy) immune system. XOLEGEL has not been studied in children below the age of 12.
It is not known whether XOLEGEL can be used to treat fungal infections.
XOLEGEL is a translucent to clear, amber colored gel.
What should I tell my health care provider before using XOLEGEL?
How should I use XOLEGEL?
What should I avoid while using XOLEGEL?
What are the possible side effects of XOLEGEL?
These are not all of the side effects of XOLEGEL. For more information, ask your health care provider or pharmacist.
How should I store XOLEGEL?
General information about XOLEGEL
Medicines are sometimes prescribed for conditions that are not mentioned in Patient Information leaflets. Do not use XOLEGEL for a condition for which it was not prescribed. Do not give XOLEGEL 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 XOLEGEL. If you would like more information, talk with your health care provider. You can also ask your pharmacist or health care provider for information about XOLEGEL that is written for health professionals.
What are the ingredients in XOLEGEL?
Active ingredient:
Inactive ingredients:
This Patient Information leaflet has been approved by the U.S. Food and Drug Administration.
The Patient Information leaflet was last revised: May 2012.
Manufactured for Almirall, LLCntttttttExton, PA 19341
Revised 12/2019ntttttttXOLEGEL is a registered trademark of Almirall, LLC.
u00a9 2019 Almirall.
almirall

PRINCIPAL DISPLAY PANEL - 45 g Carton
NDC 16110-080-45
Xolegel
AQUA
45 gramsnttttttttRx only. For topical use only.

PRINCIPAL DISPLAY PANEL - 45 g Carton
NDC 16110-080-45
Xolegel
AQUA
45 gramsnttttttttRx only. For topical use only.

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Ketoconazole (Xolegel)

Trade Name : Xolegel

GEL

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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Ketoconazole (Xolegel)

Trade Name : Xolegel

GEL

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

FAQ

Can’t find what you’re looking for?

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QUICK LINKS

CONTACT US

Can’t find what
you’re looking for?