Calamine (Topical)


VA CLASSIFICATION
Primary: DE900

Commonly used brand name(s): Calamox; Diaper Rash Ointment; Onguent de Calamine.

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



Category:


Skin protectant—{01}{09}{12}

antipruritic (topical){02}{04}{08}

Indications

Accepted

Skin irritations, minor (treatment)—Calamine is indicated for the topical relief of itching, pain, and discomfort {02} {04} {08} of minor skin irritations, {09} {13} such as those caused by poison ivy, poison oak, and poison sumac {08}.
—Calamine also has a mild astringent action on the skin {02} {04} {08} {11} and dries oozing and weeping caused by poison ivy, poison oak, and poison sumac {01} {09}.


Pharmacology/Pharmacokinetics

Physicochemical characteristics:

Calamine consists of a mixture of zinc oxide (not less than 98% and not more than 100.5%) and a small proportion of ferric oxide {10}.

Mechanism of action/Effect:

Unknown {06}.

Absorption:

Calamine applied topically is not absorbed through the skin {06}.


Precautions to Consider

Pregnancy/Reproduction

Problems in humans have not been documented {06}.

Breast-feeding

Problems in humans have not been documented {06}.

Pediatrics

Appropriate studies on the relationship of age to the effects of calamine have not been performed in the pediatric population. However, no pediatrics-specific problems have been documented to date {06} {14}.


Geriatrics


Appropriate studies on the relationship of age to the effects of calamine have not been performed in the geriatric population. However, no geriatrics-specific problems have been documented to date {06}.


Patient Consultation
As an aid to patient consultation, refer to Advice for the Patient, Calamine (Topical).

In providing consultation, consider emphasizing the following selected information (» = major clinical significance):

Proper use of this medication
For external use only; {01} {08} {09} {13} keeping away from eyes {01} {04} {08} {09} and other mucous membranes such as the mouth, nose, and anogenital region {04}

» To apply the lotion: shaking lotion well before use; using a pledget of cotton moistened with calamine and allowing to dry after application

» To apply the ointment: applying enough medication to cover affected area(s) of skin and rubbing in gently

» Proper dosing

» Proper storage{01}{09}{13}

Precautions while using this medication
Discontinuing use and checking with physician if condition worsens, or does not improve within 7 days {01} {08} {09}, or if rash, irritation, or sensitivity develops {08}


General Dosing Information
Calamine is for external use only {01} {08} {09} {13}; contact with the eyes {01} {04} {08} {09} and other mucous membranes should be avoided {04}.

Calamine lotion should be applied to the affected area(s) of skin with a cotton pledget moistened with the lotion. Then the medication should be allowed to dry on the skin {09} {13}.

A sufficient amount of calamine ointment should be applied to cover the affected area(s) of skin and rubbed in gently.

Treatment should be discontinued and the physician consulted if the condition worsens or if it does not improve within 7 days {01} {09}, or if rash, irritation, or sensitivity develops {08}.

Ingestion of calamine has been reported to cause adverse effects such as gastritis and vomiting due to irritation of gastric mucosa {03} {11}.

For treatment of adverse effects
Recommended treatment consists of the following

   • For ingestion, milk or antacids may be used to allay gastritis. {03}
Patients should seek medical help or contact a Poison Control Center (see Poison Control Center Listing ) immediately. {01} {09} {13} Patients in whom intentional ingestion is known or suspected should be referred for psychiatric consultation.


Topical Dosage Forms

CALAMINE LOTION USP

Usual adult and adolescent dose
Skin protectant or
Antipruritic (topical)
Topical, to the affected area(s) of skin as often as necessary {01} {09} {13} {14}.


Usual pediatric dose
See Usual adult and adolescent dose {09} {13} {14}.

Strength(s) usually available
U.S.—


8% (OTC)[Generic]{01}{08}{09}{12}

Canada—


8% (OTC)[Generic]{07}

Note: Calamine Lotion USP contains



• Calamine—80 grams


• Zinc oxide—80 grams


• Glycerin—20 mL


• Bentonite magma—250 mL


• Calcium hydroxide topical solution—A sufficient quantity to make 1000 mL.
The quantity of Bentonite Magma may be increased to not more than 400 mL if a more viscous consistency is desired. {10}


Packaging and storage:
Store in a light-resistant container below 40 °C (104 °F), preferably between 15 and 30 °C (59 and 86 °F), unless otherwise specified by manufacturer. Protect from freezing. Store in a tight container. {01} {04} {09} {10} {13}

Auxiliary labeling:
   • For external use only. {01} {08} {09} {13}
   • Shake well before using. {01} {09} {13}


CALAMINE OINTMENT

Usual adult and adolescent dose
See Calamine Lotion USP. {08}

Usual pediatric dose
See Calamine Lotion USP. {08}

Strength(s) usually available
U.S.—


17 grams per 100 grams (OTC) [Calamox{08}]

Canada—


5% (OTC) [Diaper Rash Ointment{07} (zinc oxide 5%)]


16% (OTC) [Onguent de Calamine{07}]

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

Auxiliary labeling:
   • For external use only. {08}



Developed: 05/26/1995



References
  1. Calamine Lotion USP bottle label (Rite Aid Corp—US), Rec 2/95.
  1. Reynolds JEF, editor. Martindale, the extra pharmacopeia. 30th ed. London: The Pharmaceutical Press, 1993: 756.
  1. Arena JM, Drew RH, editors. Poisoning. 5th ed. Springfield, Ill: Charles C. Thomas, 1986: 817.
  1. WHO Model Prescribing Information: Drugs used in skin diseases. Geneva: World Health Organization, Feb. 1993: 64.
  1. Spilker B, Wilkins RD, Perkins JG. A novel double-blind method to evaluate topically applied antipruritic drugs. Curr Ther Res Clin Exp 1984; 35(4): 593-605.
  1. Dollery C, editor. Therapeutic drugs. Edinburgh: Churchill Livingstone, 1991: C6-C7.
  1. Carruthers-Czyzewski P, editor. CNP Compendium of nonprescription products. 1st ed. Ottawa: Canadian Pharmaceutical Association, 1994: 242, 367, 370.
  1. Olin BR, editor. Drug facts and comparisons. St. Louis: Facts and Comparisons Inc, 1994: 564-4a.
  1. Calamine Lotion USP bottle label (CVS—US), Rec 2/95.
  1. The United States pharmacopeia. The national formulary. USP 23rd revision (January 1, 1995). NF 18th ed (January 1, 1995). Rockville, MD: The United States Pharmacopeial Convention, Inc., 1995: 242-3.
  1. Goodman LS, Gilman A, editors. The pharmacological basis of therapeutics. 5th ed. New York: Macmillan, 1975: 1000-1.
  1. Drug Evaluations Annual 1993. Chicago: American Medical Association, 1992: 1207.
  1. Calamine Lotion USP bottle label (Rugby—US), Rec 2/95.
  1. Reviewers' consensus on Calamine (Topical) monograph draft of 3/95.
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