Nizoral


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Related to Nizoral: Nizoral Shampoo

Nizoral

 [niz-or´al]
trademark for preparations of ketoconazole, an antifungal agent.

ketoconazole

Apo-Ketoconazole (CA), Dactarin Gold (UK), Dandrazol (UK), Extina, Kryoxolr, Nizoral, Nizoral A-D, Novo-Ketoconazole (CA), Nu-Ketocon (CA), Nu-Ketoconazole (CA), Ratio-Ketoconazole (CA), Xolegel

Pharmacologic class: Imidazole

Therapeutic class: Antifungal

Pregnancy risk category C

FDA Box Warning

• Oral form has been linked to hepatic toxicity, including some deaths. Inform patient of this risk, and monitor closely.

• Concurrent use of astemizole, cisapride, or terfenadine with ketoconazole tablets is contraindicated, because serious cardiovascular adverse events (including death, ventricular tachycardia, and torsades de pointes) have occurred.

Action

Alters fungal cell membranes, resulting in increased permeability, growth inhibition, and ultimately, cell death

Availability

Cream: 2%

Shampoo: 1%, 2%

Tablets: 200 mg

Indications and dosages

Blastomycosis; chronic mucocutaneous candidiasis; oral thrush; candiduria; coccidioidomycosis; histoplasmosis; chromomycosis; paracoccidioidomycosis; mucocutaneous or vaginal candidiasis

Adults: 200 to 400 mg P.O. daily

Children ages 2 and older: 3.3 to 6.6 mg/kg P.O. as a single daily dose. Duration depends on infection: for candidiasis, 1 to 2 weeks; other systemic mycoses, 6 months; recalcitrant dermatophyte infections involving glabrous skin, 4 weeks. Chronic mucocutaneous candidiasis requires maintenance therapy.

Scaling caused by dandruff or seborrheic dermatitis

Adults: 2% shampoo applied topically twice weekly for 4 weeks, then as needed to control symptoms, with at least 3 days between applications; or 1% shampoo applied topically q 3 to 4 days for up to 8 weeks, then as needed to control dandruff

Tinea corporis; tinea cruris; tinea versicolor; tinea pedis, cutaneous candidiasis

Adults: 2% cream applied topically to affected areas daily for 2 weeks (except for tinea pedis, which may require 6 weeks of therapy)

Contraindications

• Hypersensitivity to drug or its components

• Concurrent oral astemizole, cisapride, triazolam, or terfenadine therapy

Precautions

Use cautiously in:

• renal or hepatic disease, achlorhydria

• pregnant or breastfeeding patients

• children younger than age 2.

Administration

• Apply cream to damp skin of affected area and wide surrounding area.

• To use shampoo, wet hair, then apply shampoo and massage into scalp for 1 minute. Leave on for 5 minutes before rinsing. Rinse and repeat, this time leaving shampoo on scalp for 3 minutes before rinsing.

• Don't apply shampoo to broken or inflamed skin.

• In achlorhydria, dissolve 200-mg tablet in 4 ml of 0.2N hydrochloric acid solution.

• Withhold antacids for at least 2 hours after giving oral ketoconazole.

Don't give concurrently with cisapride, available in U.S. for compassionate use only. (Astemizole and terfenadine are not available in U.S.)

Adverse reactions

CNS: headache, nervousness, dizziness, drowsiness, severe depression, suicidal ideation

EENT: photophobia

GI: nausea, vomiting, diarrhea, abdominal pain, anorexia

GU: erectile dysfunction, gynecomastia

Hematologic: purpura, hemolytic anemia, thrombocytopenia, leukopenia

Hepatic: hepatotoxicity

Metabolic: hyperlipidemia

Skin: pruritus, rash, dermatitis, urticaria, severe irritation, stinging, alopecia, abnormal hair texture, scalp pustules, oily skin, dry hair and scalp

Other: fever, chills, allergic reaction

Interactions

Drug-drug. Antacids, anticholinergics, histamine2-receptor antagonists: decreased ketoconazole absorption

Cyclosporine: increased cyclosporine blood level

Isoniazid, rifampin: increased ketoconazole metabolism

Theophylline: decreased theophylline blood level

Topical corticosteroids: increased corticosteroid absorption

Triazolam (oral): increased triazolam effects

Drug-diagnostic tests. Alanine aminotransferase, alkaline phosphatase, aspartate aminotransferase: increased levels

Hemoglobin, platelets, white blood cells: decreased levels

Drug-herbs. Yew: inhibited ketoconazole metabolism

Patient monitoring

Assess for suicidal ideation and signs and symptoms of depression.

Monitor for evidence of hepatotoxicity, such as nausea, fatigue, jaundice, dark urine, and pale stools.

• With long-term therapy, stay alert for adrenal crisis.

Patient teaching

Advise patient to watch for signs and symptoms of depression and to immediately report suicidal thoughts.

Teach patient to recognize and immediately report signs and symptoms of hepatotoxicity, such as unusual tiredness or yellowing of skin or eyes.

• Advise patient not to take antacids for at least 2 hours after oral ketoconazole.

• Instruct patient to apply cream to damp skin of affected area and wide surrounding area.

• Tell patient to wet hair before applying shampoo and to massage into scalp for 1 minute; then leave on for 5 minutes before rinsing off. Tell him to shampoo again, leaving it on for 3 minutes this time before rinsing.

• Caution patient not to apply shampoo to broken or inflamed skin.

• As appropriate, review all other significant and life-threatening adverse reactions and interactions, especially those related to the drugs, tests, and herbs mentioned above.

Nizoral

(nī′zə-răl′)
A trademark for a preparation of ketoconazole.

Nizoral®

Ketoconazole, see there.

Nizoral

A brand name for KETOCONAZOLE.
References in periodicals archive ?
27 June 2018 - US-based over-the-counter foot care and specialty cough products marketer Kramer Laboratories, Inc has acquired anti-dandruff shampoo brand Nizoral, from US-based healthcare company Johnson and Johnson's (NYSE: JNJ) Janssen Pharmaceutica NV business, the company said.
Kramer Laboratories Inc, a marketer of over-the-counter (OTC) foot care and specialty cough products, revealed on Monday the completion of the acquisition of Nizoral from Janssen Pharmaceutica NV, a member of the Johnson & Johnson family of companies.
[6] FDA Drug Safety Communication, "FDA limits usage of Nizoral (ketoconazole) oral tablets due to potentially fatal liver injury and risk of drug interactions and adrenal gland problems," 2017(4/15), 2013.
The agreement followed a June 29 jury verdict that awarded Smith's husband, Thomas Smith Sr., $4.7 million in damages stemming from the death of his wife from the side effects of Nizoral, a powerful and potentially toxic drug that caused her liver and kidneys to fail, Krugler said.
The advisory, issued on May 19, points out that oral ketoconazole (Nizoral) is no longer approved for treating nail or skin fungal infections.
Johnson & Johnson's hair loss treatment, Regaine, antifungal treatment, Daktarin, and medicated shampoo, Nizoral, also continued to also perform extremely well.
Janssen-Cilag Ltd with its brand Nizoral maintained its leading position, accounting for a 15% value share in 2015.
This event is co-presented by Gatorade and sponsored by the following: Gold's Gym, DOCOMO, StarXpo, DOLE, Delsan Office Systems,Canon Fashion Tailoring,10 Inch Lights and sounds, Dowi Hosiery, Delizio Fine Foods, Diversey, MJ Global, M Plus, Timex, Premier water and Nizoral. Media partners include ANC, Business World, Fox International Channels, Manila Bulletin, Philippine Daily Inquirer and Radio High.
Deep infections especially nail infections will require systemic treatments such as Grisovin (Griseofluvin) or Nizoral (Ketoconazole), which target the nail bed and act on the membranes of fungal cells to prevent active growth.
Nizoral cream was used as a market product, which contains ketoconazole 2%.
Ketoconazole was initially marketed as Nizoral by Janssen Pharmaceuticals, but has since lost patent protection and is produced in generic form.
Mild cases can respond well to an anti-fungal shampoo, such as Nizoral.