One gram contains 20 mg ketoconazole.
Nizoral Shampoo 2% contains the synthetic broad spectrum antifungal agent, ketoconazole.
The shampoo formulation consists of sodium lauryl ether sulphate, disodium monolauryl ether sulphosuccinate, coconut fatty acid diethanolamide, laurdimonium hydrolyzed animal collagen, macrogol 120 methyl glucose diolaete, sodium chloride, hydrochloric acid, imidurea, perfume bouquet, sodium hydroxide, erythrosine sodium and purified water.
Pharmacotherapeutic group: Antifungal for Topical Use, Imidazole and, triazole derivatives. ATC code: D01AC08.
Pharmacology: Pharmacodynamics: Ketoconazole, a synthetic imidazole dioxolane derivative with potent antifungal activity.
Nizoral Shampoo 2% rapidly relieves scaling and pruritus, which are usually associated with seborrheic dermatitis, pityriasis capitis (dandruff) and pityriasis versicolor.
Pharmacokinetics: Plasma concentrations of ketoconazole were not detectable after topical administration of Nizoral Shampoo 2% on the scalp. Plasma levels were detected after topical administration of Nizoral Shampoo 2% on the whole body.
Treatment and prophylaxis of infections in which the yeast Malassezia (previously called Pityrosporum) is involved, such as, seborrhoeic dermatitis and pityriasis capitis (dandruff). Treatment of pityriasis versicolor (localised).
The infected areas of the skin or the scalp should be thoroughly washed with Nizoral Shampoo 2%, which should be left on the skin/scalp for 3 to 5 minutes before rinsing.
Dosage: Usually, a palmful of shampoo suffices for one wash.
Treatment: Pityriasis versicolor: Once daily for 1 to 3 days.
Seborrhoeic dermatitis and Pityriasis capitis: Twice weekly for 2 to 4 weeks.
Prophylaxis: Seborrhoeic dermatitis and Pityriasis capitis: Once every one or two weeks.
In the event of accidental ingestion, supportive and symptomatic measures should be carried out. To avoid aspiration, neither emesis nor gastric lavage should be performed.
Nizoral Shampoo 2% is contraindicated in individuals with a known hypersensitivity to any of its ingredients.
In patients who have been on prolonged treatment with topical corticosteroids, it is recommended that the steroid therapy be gradually withdrawn over a period of 2 to 3 weeks, while using Nizoral Shampoo 2% to prevent any potential rebound effect.
Avoid contact with the eyes. If the shampoo should get into the eyes, they should be bathed with cool water.
Use in Children: The safe and effective use of Nizoral Shampoo 2% in infants and children under the age of 12 years has not been established.
Pregnancy: There are no adequate and well-controlled studies in pregnant women. Plasma concentrations of ketoconazole were not detectable after topical administration of Nizoral Shampoo 2% to the scalp of non-pregnant humans. Plasma levels were detected after topical administration of Nizoral Shampoo 2% on the whole body. There are no known risks associated with the use of Nizoral Shampoo 2% in pregnancy.
Breast-feeding: There are no adequate and well-controlled studies in lactating women. There are no known risks associated with the use of Nizoral Shampoo 2% in lactation.
Clinical trial data: The safety of Nizoral Shampoo 2% was evaluated in 2890 subjects in 22 clinical trials where Nizoral Shampoo 2% was administered topically to the scalp and/or skin.
No adverse drug reactions (ADRs) were reported in ≥1% of Nizoral Shampoo 2%-treated subjects.
Adverse drug reactions that occurred in <1% of Nizoral Shampoo 2%-treated subjects in the clinical datasets are listed in Table 1. (See Table 1.)
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Post-marketing experience: Adverse drug reactions first identified during post-marketing experience with Nizoral Shampoo 2% are included in Table 2. In each table, the frequencies are provided according to the following convention: Very common ≥1/10; Common ≥1/100 and <1/10; Uncommon ≥1/1,000 and <1/100; Rare ≥1/10,000 and <1/1,000; Very rare <1/10,000, including isolated reports.
In Table 2, ADRs are presented by frequency category based on spontaneous reporting rates. (See Table 2.)
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Store below 25°C.
Shelf Life: 24 months.
D01AC08 - ketoconazole ; Belongs to the class of imidazole and triazole derivatives. Used in the topical treatment of fungal infection.
Nizoral Shampoo 2%
100 mL x 1's
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