Nizoral Shampoo (Ketoconazole)

NIZORAL® Shampoo

McNeil Consumer Products

Ketoconazole

Topical Antifungal

Action And Clinical Pharmacology: In vitro studies suggest that the antifungal properties of ketoconazole may be related to its ability to impair the synthesis of ergosterol, a component of fungal and yeast cell membranes. Without the availability of this essential sterol, there are morphological alterations of the fungal and yeast cell membranes manifested as abnormal membranous inclusions between the cell wall and the plasma membrane. The inhibition of ergosterol synthesis has been attributed to interference with the reactions involved in the removal of the 14-a-methyl group of the precursor of ergosterol, lanosterol.

Except for its specific pharmacologic effect, i.e., a sporocidal or fungicidal activity, ketoconazole when formulated in a 2% shampoo is not expected to exert any other pharmacodynamic effect when applied topically on the skin or hair.

Indications And Clinical Uses: For the topical treatment and prophylaxis of conditions in which the yeast Pityrosporum is involved, such as pityriasis capitis (dandruff). Also for seborrheic dermatitis.

Contra-Indications: In persons who have shown hypersensitivity to the active or excipient ingredients of this formulation.

Manufacturers’ Warnings In Clinical States: Irritation may occur when the shampoo is used immediately after prolonged treatment with topical corticosteroids. To prevent a rebound effect after stopping a prolonged treatment with topical corticosteroids, it is recommended to continue applying a mild topical corticosteroid at the onset of treatment with ketoconazole shampoo, and to subsequently and gradually withdraw the steroid therapy over a period of 2 to 3 weeks.

Precautions: If a reaction suggesting sensitivity or chemical irritation should occur, use of the shampoo should be discontinued.

Pregnancy and Lactation: Ketoconazole shampoo does not produce detectable blood levels after topical application. However due to the teratogenic nature of the active ingredient, ketoconazole, the use of the shampoo is not recommended in pregnant or nursing women except under the advice of a physician.

Children: Clinical data on the use of ketoconazole shampoo in children under 12 are not available; therefore, such use is not recommended except under the advice of a physician.

Adverse Reactions: Ketoconazole 2% shampoo causes minimal skin and scalp irritation. During clinical trials, 33 (3.7%) of 892 patients treated with the shampoo and 12 (3.6%) of 330 patients treated with placebo reported side effects. The adverse effects reported by patients treated with ketoconazole 2% shampoo consisted mainly of: greasy hair or scalp (1.2%); dry (brittle) hair or scalp (0.9%); irritation (0.5%); burning sensation and dryness (eyebrows) (0.2%). All other adverse experiences were reported with an incidence of 0.1%: exfoliative dermatitis; dandruff; irritation around mouth (acne perioralis); contact allergy; worsening of acne; burning sensation or pruritus (scalp); cosmetological disorder; hair loss; tiny pustules on scalp; dryness and itching of forehead and cheeks.

In rare circumstances, mainly in patients with chemically damaged hair or gray hair, a discoloration of the hair has been observed.

Symptoms And Treatment Of Overdose: Symptoms and Treatment: Ingestion is usually followed by nausea and vomiting due to the detergent. In the event of accidental ingestion, only supportive measures should be carried out. In order to avoid aspiration, neither emesis nor gastric lavage should be performed. It has been reported that ketoconazole cannot be removed by hemodialysis. tag_DosageDosage

Dosage And Administration: Adults and children over 12 years of age: Shampoo (5 to 10 mL) should be applied to the wet scalp, worked into a lather and left on for 3 to 5 minutes before rinsing with water. As with other shampoos, care should be taken to keep the shampoo out of the eyes and off the eyelids.

Treatment: Twice weekly for 2 to 4 weeks.

Prophylaxis: Once every 1 or 2 weeks.

Availability And Storage: Each mL of orange viscous shampoo contains: ketoconazole 2% (20 mg/g). Nonmedicinal ingredients: coconut fatty acid diethanolamide, disodium monolaureth sulphosuccinate, erythrosin, hydrochloric acid, imidurea, laurdimonium hydrolyzed animal collagen, macrogol 120 methyl glucose dioleate, perfume bouquet, sodium chloride, sodium hydroxide, sodium laureth sulfate and purified water. HDPE flasks of 120 mL. Store at or below 25°C. (Shown in Product Recognition Section)

NIZORAL® Shampoo McNeil Consumer Products Ketoconazole Topical Antifungal

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Dermatitis, Seborrheic

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