1. Name Of The Medicinal Product
Nizoral™ Dandruff Shampoo
2. Qualitative And Quantitative Composition
Ketoconazole 2% w/w.
For excipients, see 6.1.
3. Pharmaceutical Form
Pink viscous shampoo.
4. Clinical Particulars
4.1 Therapeutic Indications
In the prevention and treatment of the scalp conditions dandruff and seborrhoeic dermatitis.
4.2 Posology And Method Of Administration
For topical administration.
Adults, elderly and children:
Wash affected areas and leave for 3 to 5 minutes before rinsing.
Treatment:
Wash the hair every 3 or 4 days for 2 to 4 weeks.
Prophylaxis:
Use once, every 1 to 2 weeks.
Do not use more often than directed.
4.3 Contraindications
Known hypersensitivity to ketoconazole or any of the excipients.
4.4 Special Warnings And Precautions For Use
Keep out of the eyes. If the shampoo should get into the eyes, they should be bathed with water.
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have been on prolonged treatment with topical corticosteroids, it is recommended that the steroid therapy be gradually withdrawn over a period of 2 to 3 weeks, while using Nizoral Dandruff Shampoo, to prevent any potential rebound effect.
If the scalp has not cleared within 4 weeks, a doctor or pharmacist should be consulted.
4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction
None Known.
4.6 Pregnancy And Lactation
There are no adequate and well-controlled studies in pregnant or lactating women. Data on a limited number of exposed pregnancies indicate no adverse effects of topical ketoconazole on pregnancy or on the health of the foetus/newborn child. Animal studies have shown reproductive toxicity following oral administration of ketoconazole. (see Preclinical safety data, section 5.3). No effects on the breastfed newborn/infant are anticipated. See Pharmacokinetic properties, section 5.2.
Plasma concentrations of ketoconazole were not detectable after topical administration of Nizoral Dandruff Shampoo to the scalp of non-pregnant humans. Plasma levels were detected after topical administration of Nizoral Dandruff Shampoo on the whole body. There are no known risks associated with the use of Nizoral Dandruff Shampoo in pregnancy or lactation.
4.7 Effects On Ability To Drive And Use Machines
None likely.
4.8 Undesirable Effects
The safety of Nizoral Dandruff Shampoo was evaluated in 2980 subjects who participated in 22 clinical trials. Nizoral Dandruff Shampoo was administered topically to the scalp and/or skin. Based on pooled safety data from these clinical trials, there were no ADRs reported with an incidence
The following table displays ADRs that have been reported with the use of Nizoral Dandruff Shampoo from either clinical trial or postmarketing experiences. The displayed frequency categories use the following convention:
Very common (
Table 1: Adverse Drug Reactions
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4.9 Overdose
In the event of accidental ingestion, supportive and symptomatic measures should be carried out. In order to avoid aspiration, neither emesis nor gastric lavage should be instigated.
5. Pharmacological Properties
5.1 Pharmacodynamic Properties
Ketoconazole is a synthetic imidazole dioxolane antimycotic active against yeasts, including Malassezia, and dermatophytes. Its broad spectrum of activity is already well known.
Ketoconazole also has a direct anti-inflammatory action independent from its antifungal activity which may contribute to symptom relief in dandruff and seborrhoeic dermatitis.
5.2 Pharmacokinetic Properties
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.
5.3 Preclinical Safety Data
Not applicable.
6. Pharmaceutical Particulars
6.1 List Of Excipients
Sodium lauryl ether sulphate
Disodium monolauryl ether sulphosuccinate
Coconut fatty acid diethanolamide
Laurdimonium hydrolysed animal collagen
Macrogol 120 methyl glucose dioleate
Sodium chloride
Concentrated hydrochloric acid
Imidurea
Sodium hydroxide
Erythrosine sodium (E127)
Purified water
6.2 Incompatibilities
None known.
6.3 Shelf Life
3 years.
6.4 Special Precautions For Storage
Store below 25°C.
6.5 Nature And Contents Of Container
1. High-density polyethylene bottle containing 60 ml, 100 ml or 120ml Nizoral Dandruff Shampoo.
Not all pack sizes may be marketed.
6.6 Special Precautions For Disposal And Other Handling
Not applicable.
7. Marketing Authorisation Holder
McNeil Products Limited
Foundation Park
Roxborough Way
Maidenhead
Berkshire
SL6 3UG
UK
8. Marketing Authorisation Number(S)
PL 15513/0311
9. Date Of First Authorisation/Renewal Of The Authorisation
20/08/2008
10. Date Of Revision Of The Text
08/03/2011
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