Nizoral Shampoo

Each gram contains: Ketoconazole 20 mg.

Ketoconazole (Nizoral) is used for the treatment and prophylaxis of infections in which the yeast Malassezia (previously called Pityrosporum) is involved, such as, seborrheic dermatitis and pityrasis capitis (dandruff).
Treatment of pityriasis versicolor.

Usually, a palmful or 1 sachet of shampoo suffices for one wash.
Treatment: Pityriasis versicolor: once daily for 1 to 3 days.
Seborrheic dermatitis and pityriasis capitis: twice weekly for 2 to 4 weeks.
Prophylaxis: Seborrheic dermatitis and pityriasis capitis: once every 1 or 2 weeks.
Special populations: Pediatrics: The safe and effective use of Ketoconazole (Nizoral) Shampoo 2% in infants and children under the age of 12 years has not been established.
Direction for use: Topical application to the scalp or skin.
The infected areas of the skin or the scalp should be thoroughly washed with Ketoconazole (Nizoral) Shampoo 2%, which should be left on the skin/scalp for 3 to 5 minutes before rinsing.
Missed dose: Continue medication based on dosage and/or consult a doctor.

Signs and Symptoms of Overdose: Not Applicable.
When the patient has taken more than the recommended dosage: In the event of accidental ingestion, supportive and symptomatic measures should be carried out. To avoid aspiration, emesis or gastric lavage should not be performed.

Ketoconazole (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have been on prolonged treatment with topical corticosteroids, it is recommended that the steroid therapy be gradually withdrawn over a period of 2 to 3 weeks, while using Ketoconazole (Nizoral) Shampoo 2%, to prevent any potential rebound effect.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 irrigated with water.
When to consult a doctor: Consult a doctor if the patient has taken more than the recommended dosage.
Effects on Ability to Drive and Use Machines: Not applicable.

Pregnancy: There are no adequate and well-controlled studies in pregnant women. Plasma concentrations of ketoconazole were not detectable after topical administration of Ketoconazole (Nizoral) Shampoo 2% to the scalp of non-pregnant humans. Plasma levels were detected after topical administration of Ketoconazole (Nizoral) Shampoo 2% on the whole body. There are no known risks associated with the use of Ketoconazole (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 Ketoconazole (Nizoral) Shampoo 2% in lactation.

Throughout this section, adverse reactions are presented. Adverse reactions are adverse events that were considered to be reasonably associated with the use of Ketoconazole based on the comprehensive assessment of the available adverse event information. A causal relationship with Ketoconazole cannot be reliably established in individual cases. Further, 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.
Clinical trial data: The safety of Ketoconazole (Nizoral) Shampoo 2% was evaluated in 2890 subjects in 22 clinical trials where Ketoconazole (Nizoral) Shampoo 2% was administered topically to the scalp and/or skin. No adverse reactions were reported in ≥1% of Ketoconazole (Nizoral) Shampoo 2%-treated subjects. Adverse reactions that occurred in <1% of Ketoconazole (Nizoral) Shampoo 2%-treated subjects in the clinical datasets are listed in Table 1. (See Table 1.)

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Postmarketing data: In addition to the adverse reactions reported during clinical studies and listed previously, the following adverse reactions have been reported during postmarketing experience. In each table, the frequencies are provided according to the following convention: Very common ≥ 1/10, Common ≥ 1/100 and < 1/10, Uncommon ≥ 1/1000 and < 1/100, Rare ≥ 1/10000 and < 1/1000, Very rare < 1/10000, including isolated reports. (See Table 2.)

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None known.

Store at temperatures not exceeding 25°C.

Psoriasis, Seborrhea & Ichthyosis Preparations

D01AC08 - ketoconazole ; Belongs to the class of imidazole and triazole derivatives. Used in the topical treatment of fungal infection.

Non-Rx