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Pyrithione (Topical)


VA CLASSIFICATION
Primary: DE400

Commonly used brand name(s): Brylcreem Antidandruff; DHS Zinc; Denorex Advanced Formula; DermaZinc Baby; DermaZinc Cream; DermaZinc Scalp; DermaZinc Shampoo; DermaZinc Soap; DermaZinc Spray; Head & Shoulders Dandruff Shampoo (Fine or Oily Hair); Head & Shoulders Dandruff Shampoo (Normal Hair); Head & Shoulders Dandruff Shampoo Plus Conditioner 2 in 1 (Fine or Oily Hair); Head & Shoulders Dry Scalp (Normal or Dry Hair); Pert Plus Dandruff Control (Complete Dandruff Shampoo Plus Conditioner In One) (Extra Body for Fine or Oily Hair); Pert Plus Dandruff Control (Complete Dandruff Shampoo Plus Conditioner In One) (Normal or Dry Hair); Pret Plus Dandruff Control (Complete Dandruff Shampoo Plus Conditioner In One) (Extra Body for Fine or Oily Hair); Pret Plus Dandruff Control (Complete Dandruff Shampoo Plus Conditioner In One) (Normal or Dry Hair); Sebulon; Theraplex Z; XSeb; XSeb Plus; Z-Plus; ZNP Bar; ZNP Shampoo; Zincon; dan-gard.

Note: For a listing of dosage forms and brand names by country availability, see Dosage Forms section(s).



Category:


Antiseborrheic—

Indications

Accepted

Dandruff (treatment) or
Dermatitis, seborrheic (treatment)—Depending on the formulation, pyrithione is indicated to help control dandruff and seborrheic dermatitis of the scalp and/or seborrheic dermatitis of the body, face, and scalp. {14} {20} {21}


Pharmacology/Pharmacokinetics

Physicochemical characteristics:
Molecular weight—
    317.71 {05}

Mechanism of action/Effect:

Pyrithione may act by an antimitotic action, resulting in a reduction in the turnover of epidermal cells. It also has bacteriostatic and fungistatic activity, but it is not known if this action contributes to the antiseborrheic effects of the drug.


Precautions to Consider

Pregnancy/Reproduction

Problems in humans have not been documented.

Breast-feeding

Problems in humans have not been documented.

Pediatrics

Appropriate studies on the relationship of age to the effects of pyrithione have not been performed in the pediatric population. However, no pediatrics-specific problems have been documented to date.


Geriatrics


Appropriate studies on the relationship of age to the effects of pyrithione have not been performed in the geriatric population. However, no geriatrics-specific problems have been documented to date.

Medical considerations/Contraindications
The medical considerations/contraindications included have been selected on the basis of their potential clinical significance (reasons given in parentheses where appropriate)— not necessarily inclusive (» = major clinical significance).


Risk-benefit should be considered when the following medical problem exists
Sensitivity to pyrithione


Side/Adverse Effects
The following side/adverse effects have been selected on the basis of their potential clinical significance (possible signs and symptoms in parentheses where appropriate)—not necessarily inclusive:

Those indicating need for medical attention
Incidence more frequent
    
Irritation of skin





Overdose
For more information on the management of overdose or unintentional ingestion, contact a Poison Control Center (see Poison Control Center Listing ).

Treatment of overdose
To decrease absorption—Emesis and gastric lavage for accidental ingestion.

Supportive care—Administration of fluids. Patients in whom intentional overdose is known or suspected should be referred for psychiatric consultation.


Patient Consultation
As an aid to patient consultation, refer to Advice for the Patient, Pyrithione (Topical) .
In providing consultation, consider emphasizing the following selected information (» = major clinical significance):

Before using this medication
»   Conditions affecting use, especially:
Sensitivity to pyrithione

Proper use of this medication
For best results, using medication at least 2 times a week or as directed by physician {14}

Proper administration
Before applying—Wetting hair and scalp with lukewarm water

Applying enough shampoo to work up lather; rubbing in well; rinsing

Applying shampoo again and rinsing thoroughly
» Avoiding contact with the eyes; flushing thoroughly with water if medication accidentally gets in eyes {14}

» Proper dosing
Missed dose: Using as soon as possible; not using if almost time for next dose

» Proper storage

Precautions while using this medication
Checking with physician if condition does not get better after regular use, or if it gets worse {14}


Side/adverse effects
Signs of potential side effects, especially skin irritation


General Dosing Information
The scalp and hair should be wet with lukewarm water and enough shampoo massaged into the scalp to work up a lather; then the scalp and hair should be rinsed. Application should be repeated, then the scalp and hair rinsed thoroughly.


Topical Dosage Forms

PYRITHIONE ZINC BAR

Usual adult and adolescent dose
Dandruff or
Dermatitis, seborrheic
Topical, to the affected skin of the body, face, or scalp, once a day for at least two times a week or as directed by physician. Lather, massage into affected skin or scalp, rinse, and repeat. {01} {02}


Usual pediatric dose
See Usual adult and adolescent dose .

Strength(s) usually available
U.S.—


2% (OTC) [ZNP Bar{02}] [DermaZinc Soap{03}]

Canada—


2% (OTC) [ZNP Bar{01}]

Packaging and storage:
Store below 40 °C (104 °F), preferably between 15 and 30 °C (59 and 86 °F), in a well-closed container, unless otherwise specified by manufacturer.

Auxiliary labeling:
   • For external use only. {01}


PYRITHIONE ZINC CREAM

Usual adult and adolescent dose
Dandruff or
Dermatitis, seborrheic
For DermaZinc Cream: Topical, to affected areas of the body, face, and scalp, one to three times a day, unless directed otherwise by physician {03}.

For Brylcreem Antidandruff: Topical, to the scalp after shampooing and toweling hair dry, once a day, massaged into the scalp for one minute {17}.


Usual pediatric dose
Dandruff or
Dermatitis, seborrheic
For DermaZinc Cream: Topical, to the scalp, see Usual adult and adolescent dose .

For Brylcreem Antidandruff: Safety and efficacy have not been established.


Strength(s) usually available
U.S.—


0.25% (OTC) [DermaZinc Cream{03}]

Canada—


0.1% (OTC) [Brylcreem Antidandruff{17}]

Packaging and storage:
Store below 40 °C (104 °F), preferably between 15 and 30 °C (59 and 86 °F), in a well-closed container, unless otherwise specified by manufacturer.

Auxiliary labeling:
   • For external use only. {01}


PYRITHIONE ZINC LOTION

Usual adult and adolescent dose
Dandruff or
Dermatitis, seborrheic
For DermaZinc Scalp: Topical, to the scalp, one to three times a day or as directed by a physician {03}.

For DermaZinc Spray: Topical, to affected areas of the body, face, or scalp, one spray one to three times a day or as directed by a physician. Medication should be applied from a distance of three to four inches. One spray covers a three-inch-square area; treatment should be continued until symptoms are improved for one week {03}.


Usual pediatric dose
Dandruff or
Dermatitis, seborrheic
For DermaZinc Baby: Topical, to affected areas of body, face, or scalp, one to four times a day or as directed by a physician {03}.


Strength(s) usually available
U.S.—


0.25% (OTC) [DermaZinc Baby{03} (alcohol 5%)] [DermaZinc Scalp{03} (alcohol)] [DermaZinc Spray{03} (alcohol)]

Canada—
Not commercially available.

Packaging and storage:
Store below 40 °C (104 °F), preferably between 15 and 30 °C (59 and 86 °F), in a well-closed container, unless otherwise specified by manufacturer.

Auxiliary labeling:
   • For external use only {03}.
   • Shake well {03}.


Caution:
For DermaZinc Scalp and DermaZinc Spray: Flammable. Keep away from open flame.


PYRITHIONE ZINC LOTION SHAMPOO

Usual adult and adolescent dose
Dandruff or
Dermatitis, seborrheic
Topical, to the scalp, once a day for at least two times a week. Apply after wetting hair, leave on scalp for several minutes or massage vigorously, then rinse. May be used once a day if needed. {06}


Usual pediatric dose
Dandruff or
Dermatitis, seborrheic
For children up to 2 years of age—Safety and efficacy have not been established {15}.

For children 2 years of age and older—See Usual adult and adolescent dose.


Strength(s) usually available
U.S.—


1% (OTC) [Head & Shoulders Dandruff Shampoo (Fine or Oily Hair){12}] [Head & Shoulders Dandruff Shampoo (Normal Hair){12}{20}] [Head & Shoulders Dandruff Shampoo Plus Conditioner 2 in 1 (Fine or Oily Hair){12}] [Head & Shoulders Dry Scalp (Normal or Dry Hair){13}{21}] [Pert Plus Dandruff Control (Complete Dandruff Shampoo Plus Conditioner In One) (Extra Body for Fine or Oily Hair)] [Pert Plus Dandruff Control (Complete Dandruff Shampoo Plus Conditioner In One) (Normal or Dry Hair)] [XSeb{10}] [XSeb Plus{11}] [Zincon{15}]


2% (OTC) [DermaZinc Shampoo{03} (methylparaben) (propylparaben) (water)] [Denorex Advanced Formula{08}] [DHS Zinc{16}] [Sebulon{09}] [Theraplex Z{04}]

Canada—


1% (OTC) [Head & Shoulders Dandruff Shampoo (Fine or Oily Hair){06}] [Head & Shoulders Dandruff Shampoo (Normal Hair){06}] [Head & Shoulders Dandruff Shampoo Plus Conditioner 2 in 1 (Fine or Oily Hair){06}] [Head & Shoulders Dry Scalp (Normal or Dry Hair){06}] [Pert Plus Dandruff Control (Complete Dandruff Shampoo Plus Conditioner In One) (Extra Body for Fine or Oily Hair){07}] [Pert Plus Dandruff Control (Complete Dandruff Shampoo Plus Conditioner In One) (Normal or Dry Hair){07}] [Pret Plus Dandruff Control (Complete Dandruff Shampoo Plus Conditioner In One) (Extra Body for Fine or Oily Hair){07}] [Pret Plus Dandruff Control (Complete Dandruff Shampoo Plus Conditioner In One) (Normal or Dry Hair){07}] [Zincon{15}] [ZNP Shampoo{21}]


2% (OTC) [dan-gard{18}] [Sebulon{19}] [Z-Plus{22}]

Packaging and storage:
Store below 40 °C (104 °F), preferably between 15 and 30 °C (59 and 86 °F), in a well-closed container, unless otherwise specified by manufacturer. Protect from freezing.

Auxiliary labeling:
   • For external use only. {14}
   • Shake well.



Revised: 08/13/1998



References
  1. ZNP Bar packaging (Stiefel—Canada), Rec 7/15/98.
  1. ZNP Bar packaging (Stiefel—US), Rec 7/15/98.
  1. DermaZinc Cream (Dermalogix Partners—US), Rec 3/19/98.
  1. Theraplex Z packaging (Medicis), Rec 7/15/98.
  1. Canada JR, editor. USP dictionary of USAN and international drug names 1998. Rockville, MD: The United States Pharmacopeial Convention Inc; 1997. p. 617-8.
  1. Head & Shoulders packaging (Procter & Gamble—Canada), Rec 7/15/98.
  1. Pert Plus and Pret Plus packaging (Procter & Gamble—Canada), Rec 7/15/98.
  1. Denorex Advanced Formula packaging (Whitehall Robins—US), Rec 7/15/98.
  1. Sebulon packaging (Westwood Squibb—US), Rec 3/10/98.
  1. XSeb packaging (Baker Norton—US), Rev 5/96, Rec 7/15/98.
  1. XSeb Plus packaging (Baker Norton—US), Rev 7/96, Rec 7/15/98.
  1. Head & Shoulders. In: PDR Physicians' desk reference for nonprescription drugs. 19th ed. 1998. Montvale, NJ: Medical Economics Company Inc; 1998. p. 738-9.
  1. Head & Shoulders Dry Scalp Shampoo. In: PDR Physicians' desk reference for nonprescription drugs. 19th ed. 1998. Montvale, NJ: Medical Economics Company Inc; 1998. p. 738-9.
  1. Department of Health and Human Services. Food and Drug Administration. 21 CFR Parts 310 and 358. Dandruff, seborrheic dermatitis, and psoriasis drug products for over-the-counter human use; final rule. Federal Register 1991 Dec 4 Wed; 56(233): 63554-69.
  1. Zincon packaging (Medtech—US), Rec 7/15/98.
  1. DHS Zinc packaging (Person & Covey—US), Rec 7/15/98.
  1. Brylcreem Anti-dandruff packaging (SmithKline Beecham Consumer Healthcare—Canada), Rec 7/16/98.
  1. dan-gard packaging (Stiefel—Canada), Rec 7/15/98.
  1. Sebulon (Westwood-Squibb). In: Gillis MC, editor. CPS Compendium of pharmaceuticals and specialties. 33rd ed. Ottawa: Canadian Pharmacists Association; 1998. p. 1514.
  1. Head and Shoulders. In: PDR Physicians' desk reference for nonprescription drugs. 19th ed. 1998. Montvale, NJ: Medical Economics Company Inc; 1998. p. 738-9.
  1. Head and Shoulders Dry Scalp. In: PDR Physicians' desk reference for nonprescription drugs. 19th ed. 1998. Montvale, NJ: Medical Economics Company Inc; 1998. p. 738-9.
  1. Z-Plus packaging (Dormer—Canada), Rec 7/15/98.
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