Nizoral Shampoo for Skin Infections 100ml 20 mg/g

Nizoral Shampoo is a Ketoconazole-based drug indicated in the treatment of scalp infections involving the yeast Malassezia (formerly called Pityrosporum), such as localized seborrheic dermatitis (pityriasis versicolor) and pityriasis capitis (dandruff).

Dosage
Wash affected areas with NIZORAL shampoo and leave for 3–5 minutes before rinsing. Treatment: • dandruff: twice a week for 2–4 weeks • seborrheic dermatitis: twice a week for 2–4 weeks Nizoral shampoo can be used by adults and adolescents.

Active principles
One gram of Nizoral shampoo contains: Active ingredient: Ketoconazole 20.00 mg For the full list of excipients see section 6.1

Excipients
Sodium lauryl ether sulfate; disodium lauryl semisulfosuccinate; coconuthyldiethanolamide; hydrolyzed laurdimonium (animal collagen); macrogol 120 methylglucose dioleate; perfume; imidazolidinylurea; hydrochloric acid; sodium chloride; sodium hydroxide; erythrosine; purified water.

Contraindications
Hypersensitivity to the active substance or to any of the excipients.

Warnings
To prevent the rebound effect after discontinuation of prolonged treatment with topical corticosteroids, it is recommended to continue the application of a small amount of corticosteroids and gradually reduce it until the application of corticosteroids is discontinued over a period of 2–3 weeks. Given the poor percutaneous absorption of ketoconazole, no systemic side effects are to be expected following the use of the product, nevertheless elderly patients, those with a history of liver disease and those already treated previously with griseofulvin, should be treated with great caution, stopping treatment if signs suggestive of a liver reaction develop. The use, especially if prolonged, of the product can give rise to sensitization phenomena; in this case it is necessary to interrupt the treatment and consult the attending physician. If the product comes into contact with the eyes, rinse well with water.

Pregnancy
There are no adequate clinical studies in pregnant or lactating women. After topical application of Nizoral Shampoo 2% on the scalp of non-pregnant women, plasma concentrations of ketoconazole are not detectable. Plasma levels are determined on the whole body after topical application of Nizoral Shampoo 2%. There are no known associated risks with the use of Nizoral Shampoo 2% during pregnancy and breastfeeding.

Side effects
The safety of Nizoral Shampoo 2% was evaluated in 2890 subjects who participated in 22 clinical studies. Nizoral Shampoo 2% was administered topically to the scalp and / or skin. Based on the safety data collected during these clinical studies, no adverse reactions with an incidence ≥1% were reported. The table below lists the adverse reactions that were observed following the use of Nizoral 2% shampoo both during clinical trials and during post-marketing experience. Frequencies are reported according to the following conventional classification: Very common (≥1 / 10); Common (≥1 / 100 and <1/10); Uncommon (≥1 / 1,000 and <1/100); Rare (≥1 / 10,000 and <1/1000); Very rare (<1 / 10,000); not known (frequency cannot be estimated from the available clinical data)

System Organ Classifications Adverse Reactions
Frequencies
Uncommon (≥1 / 1,000 to <1/100) Not known
Nervous system disorders Dysgeusia
Infections and infestations Folliculitis
Eye disorders Eye irritation, lacrimation increased
Skin and subcutaneous tissue disorders Acne, alopecia, contact dematitis, dry skin, abnormal hair structure, rash, burning sensation, skin peeling, skin disorders Urticaria, change in hair color, angioedema
General disorders and administration site conditions Administration site erythema, administration site irritation, administration site hypersensitivity, administration site pruritus, administration site pustules, administration site reactions
Overdose
There are no known cases of overdose. Poor percutaneous absorption of the drug makes overdose symptoms and signs unlikely. In case of accidental ingestion, take supportive and symptomatic measures; to avoid aspiration of the product, do not induce vomiting and do not perform gastric lavage.

Interactions
No interaction studies have been performed.

storage
Store at a temperature not exceeding 25 ° C.