Drug Catalog - Product Detail
CALCITRIOL OINTMENT OINT 3MCG/GM 100GM
| NDC | Mfr | Size | Str | Form |
|---|---|---|---|---|
| 45802-0608-01 | PADAGIS | 100 | 3MCG/GM | OINTMENT |
PACKAGE FILES
Generic Name
CALCITRIOL
Substance Name
CALCITRIOL
Product Type
HUMAN PRESCRIPTION DRUG
Route
TOPICAL
Application Number
NDA022087
Description
11 DESCRIPTION Calcitriol Ointment, 3 mcg/g is a vitamin D analog intended for topical application to the skin. The chemical name of the active ingredient is (5Z,7E)-9, 10-secocholesta-5,7,10(19)-triene-1α, 3β,25-triol. The structural formula is: Calcitriol is a white or almost white crystalline solid. It is practically insoluble in water, soluble in alcohol and in fatty oils. The molecular formula is C 27 H 44 O 3 , and the molecular weight is 416.64. Calcitriol Ointment is a translucent ointment containing 3 mcg/g (0.0003% w/w) of calcitriol, packaged in aluminum tubes with screw caps. Other components of the ointment are mineral oil, dl-α-tocopherol, and white petrolatum. chem-stuct
How Supplied
16 HOW SUPPLIED/STORAGE AND HANDLING 16.1 How Supplied Calcitriol Ointment 3 mcg/g is available in collapsible aluminum tubes of the following package sizes: 100 g tube (NDC 45802-608-01) 16.2 Storage Store at controlled room temperature 68° - 77°F (20° - 25°C) with excursions permitted between 59° - 86°F (15° - 30°C). [See USP Controlled Room Temperature.] Do not freeze or refrigerate.
Indications & Usage
1 INDICATIONS AND USAGE Calcitriol Ointment is a vitamin D analog indicated for the topical treatment of mild to moderate plaque psoriasis in adults and pediatric patients 2 years and older ( 1.1 ) Limitations of Use The safety and effectiveness of Calcitriol Ointment in patients with known or suspected disorders of calcium metabolism have not been evaluated. ( 1.2 ) 1.1 Indication Calcitriol Ointment is indicated for the topical treatment of mild to moderate plaque psoriasis in adults and pediatric patients 2 years and older. 1.2 Limitations of Use The safety and effectiveness of Calcitriol Ointment in patients with known or suspected disorders of calcium metabolism have not been evaluated.
Dosage and Administration
2 DOSAGE AND ADMINISTRATION Apply Calcitriol Ointment to affected areas twice daily, morning and evening. Adults: the maximum weekly dose should not exceed 200 grams. Pediatrics: 2 to 6 years of age: the maximum weekly dose should not exceed 100 grams. 7 years of age and older: the maximum weekly dose should not exceed 200 grams Calcitriol Ointment should not be applied to the eyes, lips, or facial skin. Calcitriol Ointment is for topical use only. Calcitriol Ointment is not for oral, ophthalmic or intravaginal use. Apply Calcitriol Ointment to affected areas of the body twice daily ( 2 ). Adults: The maximum weekly dose should not exceed 200 grams. ( 2 ) Pediatrics: 2 to 6 years of age: the maximum weekly dose should not exceed 100 grams. ( 2 ) 7 years of age and older: the maximum weekly dose should not exceed 200 grams. ( 2 ) For topical use only. ( 2 ) Not for oral, ophthalmic, or intravaginal use. ( 2 )