Vectical Information
Vectical (Calcitriol)
Vectical (Calcitriol) Indications And Usage
1.1 Indication
Vectical (Calcitriol) Ointment is indicated for the topical treatment of mild to moderate plaque psoriasis in adults 18 years and older.
1.2 Limitations of Use
Vectical (Calcitriol) Ointment should not be applied to the eyes, lips, or facial skin.
Vectical (Calcitriol) Dosage And Administration
Apply Vectical (Calcitriol) Ointment to affected areas twice daily, morning and evening. The maximum weekly dose should not exceed 200 grams.
Vectical (Calcitriol) Ointment is not for oral, ophthalmic or intravaginal use.
Vectical (Calcitriol) Dosage Forms And Strengths
Each gram of ointment contains 3 micrograms (mcg/g) of calcitriol.
Vectical (Calcitriol) Contraindications
Vectical (Calcitriol) Warnings And Precautions
In controlled clinical trails with Vectical (Calcitriol) Ointment, among subjects having laboratory monitoring, hypercalcemia was observed in 24% (18/74) of subjects exposed to active drug and in 16% (13/79) of subjects exposed to vehicle. However, the increases in calcium and albumin-adjusted calcium levels were less than 10% above the upper limit of normal.
If aberrations in parameters of calcium metabolism occur, treatment should be discontinued until these parameters have normalized. The effects of Vectical (Calcitriol) Ointment on calcium metabolism following treatment durations greater than 52 weeks have not been evaluated. Increased absorption may occur with occlusive use.
Animal data suggest that the vehicle of Vectical (Calcitriol) Ointment may enhance the ability of ultraviolet radiation (UVR) to induce skin tumors [ ]
Subjects who apply Vectical (Calcitriol) Ointment to exposed skin should avoid excessive exposure of the treated areas to either natural or artificial sunlight, including tanning booths and sun lamps. Physicians may wish to limit or avoid use of phototherapy in patients who use Vectical (Calcitriol) Ointment.
The safety and effectiveness of Vectical (Calcitriol) Ointment in patients with known or suspected disorders of calcium metabolism have not been evaluated.
The safety and effectiveness of Vectical (Calcitriol) Ointment in patients with erythrodermic, exfoliative, or pustular psoriasis have not been evaluated.
Vectical (Calcitriol) Adverse Reactions
Because clinical studies are conducted under widely varying conditions, adverse reaction rates observed in the clinical studies of a drug cannot be directly compared to rates in the clinical studies of another drug and may not reflect the rates observed in practice.
Vectical (Calcitriol) Drug Interactions
Vectical (Calcitriol) Ointment should be used with caution in patients receiving medications known to increase the serum calcium level, such as thiazide diuretics. Caution should also be exercised in patients receiving calcium supplements or high doses of vitamin D [ ].
Vectical (Calcitriol) Use In Specific Populations
Teratogenic Effects: Pregnancy Category C.
Vectical (Calcitriol) Ointment contains calcitriol which has been shown to be fetotoxic. There are no adequate and well-controlled studies for Vectical (Calcitriol) Ointment in pregnant women. Vectical (Calcitriol) Ointment should be used during pregnancy only if the potential benefit to the patient justifies the potential risk to the fetus.
Teratogenicity studies with calcitriol were performed in which rats were treated orally at dosages up to 0.9 mcg/kg/day (5.4 mcg/m/day) and in which rabbits received topical application of calcitriol ointment (3 ppm) to 6.4% of the body surface area. No effects on reproductive or fetal parameters were observed in rats. In rabbits, topically applied calcitriol induced a significantly elevated mean post-implantation loss and an increased incidence of minor skeletal abnormalities due to retarded ossification of the pubic bones. A slightly increased incidence of skeletal variation (extra 13 rib, reduced ossification of epiphyses) was also observed. These effects may have been secondary to maternal toxicity. Based on the recommended human dose and instructions for use, it is not possible to calculate human dose equivalents for animal exposures in these studies.
Vectical (Calcitriol) Overdosage
Topically applied calcitriol can be absorbed in sufficient amounts to produce systemic effects [ ]
Vectical (Calcitriol) Description
Vectical (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 CHO, and the molecular weight is 416.64.
Vectical (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.
Vectical (Calcitriol) Clinical Pharmacology
The contribution to efficacy of individual components of the vehicle has not been established.
Vectical (Calcitriol) Patient Counseling Information
This information is intended to aid in the safe and effective use of this medication. It is not a disclosure of all possible adverse or intended effects.
Patients using Vectical (Calcitriol) Ointment should receive the following information:
Vectical (Calcitriol) Package Label
See package insert for complete prescribing information.
Marketed by:GALDERMA LABORATORIES, L.P.Fort Worth, Texas 76177 USAManufactured by:Galderma Production Canada Inc.Baie d’Urfé, QC, H9X 3S4 CanadaMade in Canada.GALDERMA is a registered trademark.P51449-1
