CALCITRIOL ointment

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

CALCITRIOL (UNII: FXC9231JVH) (CALCITRIOL - UNII:FXC9231JVH)

Available from:

Padagis Israel Pharmaceuticals Ltd

INN (International Name):

CALCITRIOL

Composition:

CALCITRIOL 3 ug in 1 g

Administration route:

TOPICAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Calcitriol Ointment is indicated for the topical treatment of mild to moderate plaque psoriasis in adults and pediatric patients 2 years and older. The safety and effectiveness of Calcitriol Ointment in patients with known or suspected disorders of calcium metabolism have not been evaluated. None Risk Summary Available data from pregnancies that occurred during the clinical development of Calcitriol Ointment and published cases of oral and intravenous calcitriol use in pregnant women have not identified a drug associated risk for major birth defects, miscarriages, or adverse maternal or fetal outcomes. In animal reproduction studies, topical administration of calcitriol to pregnant rabbits during the period organogenesis resulted in an increased incidence of fetal deaths, as well as an increased incidence of minor skeletal abnormalities (see Data ).  The available data do not allow the calculation of relevant comparisons between the systemic exposures of calcitriol observed in animal studies to the syste

Product summary:

Calcitriol Ointment 3 mcg/g is available in collapsible aluminum tubes of the following package sizes: 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.

Authorization status:

New Drug Application Authorized Generic

Summary of Product characteristics

CALCITRIOL- CALCITRIOL OINTMENT
PADAGIS ISRAEL PHARMACEUTICALS LTD
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
CALCITRIOL OINTMENT SAFELY
AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR CALCITRIOL
OINTMENT.
CALCITRIOL OINTMENT,
FOR TOPICAL USE
INITIAL U.S. APPROVAL: 1978
RECENT MAJOR CHANGES
Indications and Usage (1) Date 07/2020
Dosage and Administration (2) Date 072020
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)
DOSAGE AND ADMINISTRATION
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)
DOSAGE FORMS AND STRENGTHS
Ointment, 3 mcg/g (3)
CONTRAINDICATIONS
None (4)
WARNINGS AND PRECAUTIONS
Effects on Calcium metabolism: Risk of hypercalcemia. If aberrations
in parameters of calcium
metabolism are noted discontinue Calcitriol Ointment until these
normalize. Increased absorption may
occur with occlusive use. (5.1)
Calcitriol Ointment should be used with caution in patients receiving
medications known to increase the
serum calcium level, such as thiazide diuretics, and in patients
receiving calcium supplements or high
doses of vitamin D. (5.1)
ADVERSE REACTIONS
Most common adverse reactions (incidence > 3%) are hypercalcemia,
hypercalciuria, and skin
discomfort. (6.1)
TO REPORT SUSPECTED ADVERSE REACTIONS, CONTACT PADAGIS AT
1-866-634-9120 OR FDA AT 1-
800-FDA-1088 OR WWW.FDA.GOV/MEDWATCH.
SEE 17