Drug: Dovonex Ointment

Dovonex® (calcipotriene ointment), 0.005% contains the compound calcipotriene, a synthetic vitamin D3 derivative, for topical dermatological use. Chemically, calcipotriene is (5Z,7E,22E,24S)-24-cyclopropyl-9,10-secochola-5,7,10(19), 22-tetraene-1α,3β,24-triol-, with the empirical formula C27H40O3, a molecular weight of 412.6, and the following structural formula: Calcipotriene is a white or off-white crystalline substance. Dovonex® ointment contains calcipotriene 50 µg/g in an ointment base of dibasic sodium phosphate, edetate disodium, mineral oil, petrolatum, propylene glycol, tocopherol, steareth-2 and water.

Source: http://www.rxlist.com

In controlled clinical trials, the most frequent adverse reactions reported for Dovonex® (calcipotriene ointment) were burning, itching and skin irritation, which occurred in approximately 10-15% of patients. Erythema, dry skin, peeling, rash, dermatitis, worsening of psoriasis including development of facial/scalp psoriasis were reported in 1 to 10% of patients. Other experiences reported in less than 1% of patients included skin atrophy, hyperpigmentation, hypercalcemia, and folliculitis. Once daily dosing has not been shown to be superior in safety to twice daily dosing. Read the Dovonex Ointment (calcipotriene ointment) Side Effects Center for a complete guide to possible side effectsLearn More »

Source: http://www.rxlist.com

Apply a thin layer of Dovonex® (calcipotriene ointment) ointment once or twice daily and rub in gently and completely.

Source: http://www.rxlist.com

No information provided. Last reviewed on RxList: 5/6/2008
This monograph has been modified to include the generic and brand name in many instances.

Source: http://www.rxlist.com

Dovonex® (calcipotriene ointment), 0.005%, is indicated for the treatment of plaque psoriasis in adults. The safety and effectiveness of topical calcipotriene in dermatoses other than psoriasis have not been established.

Source: http://www.rxlist.com

Dovonex® (calcipotriene ointment) is contraindicated in those patients with a history of hypersensitivity to any of the components of the preparation. It should not be used by patients with demonstrated hypercalcemia or evidence of vitamin D toxicity. Dovonex® (calcipotriene ointment) should not be used on the face.Last reviewed on RxList: 5/6/2008
This monograph has been modified to include the generic and brand name in many instances.

Source: http://www.rxlist.com

Topically applied Dovonex® (calcipotriene ointment) can be absorbed in sufficient amounts to produce systemic effects. Elevated serum calcium has been observed with excessive use of Dovonex® (calcipotriene ointment) ointment.

Source: http://www.rxlist.com

Dovonex® (calcipotriene ointment), 0.005% is available in: 60 gram aluminum tubes N 0430-3010-15
120 gram aluminum tubes N 0430-3010-17 Storage Store at controlled room temperature 15° C - 25° C (59° F - 77° F). Do not freeze. Manufactured by LEO Laboratories Ltd. Dublin, Ireland. Marketed by: Warner Chilcott (US), Inc. Rockaway, NJ 07866 USA. 1-800-521-8813. Revised November 2007. FDA Rev date: 9/26/2007 Last reviewed on RxList: 5/6/2008
This monograph has been modified to include the generic and brand name in many instances.

Source: http://www.rxlist.com

General Use of Dovonex® (calcipotriene ointment) may cause irritation of lesions and surrounding uninvolved skin. If irritation develops, Dovonex® (calcipotriene ointment) should be discontinued. For external use only. Keep out of the reach of children. Always wash hands thoroughly after use. Transient, rapidly reversible elevation of serum calcium has occurred with use of Dovonex® (calcipotriene ointment) . If elevation in serum calcium outside the normal range should occur, discontinue treatment until normal calcium levels are restored. Carcinogenesis, Mutagenesis, Impairment of Fertility When calcipotriene was applied topically to mice for up to 24 months at dosages of 3, 10 and 30 µg/kg/day (corresponding to 9, 30 and 90 µg/m2/day), no significant changes in tumor incidence were observed when compared to control. In a study in which albino hairless mice were exposed to both UVR and topically applied calcipotriene, a reduction in the time required for UVR to induce the formation of skin tumors was observed (statistically significant in males only), suggesting that calcipotriene may enhance the effect of UVR to induce skin tumors. Patients that apply Dovonex® (calcipotriene ointment) to exposed portions of the body should avoid excessive exposure to either natural or artificial sunlight (including tanning booths, sun lamps, etc.). Physicians may wish to avoid use of phototherapy in patients that use Dovonex®. Calcipotriene did not elicit any mutagenic effects in an Ames mutagenicity assay, a mouse lymphoma TK locus assay, a human lymphocyte chromosome aberration assay, or in a micronucleus assay conducted in mice. Studies in rats at doses up to 54 µg/kg/day (324 µg/m2/day) of calcipotriene indicated no impairment of fertility or general reproductive performance. Pregnancy Teratogenic Effects: Pregnancy Category C Studies of teratogenicity were done by the oral route where bioavailability is expected to be approximately 40-60% of the administered dose. In rabbits, increased maternal and fetal toxicity were noted at a dosage of 12 µg/kg/day (132 µg/m2/day); a dosage of 36 µg/kg/day (396 µg/m2/day) resulted in a significant increase in the incidence of incomplete ossification of the pubic bones and forelimb phalanges of fetuses. In a rat study, a dosage of 54 µg/kg/day (318 µg/m2/day) resulted in a significantly increased incidence of skeletal abnormalities (enlarged fontanelles and extra ribs). The enlarged fontanelles are most likely due to calcipotriene's effect upon calcium metabolism. The estimated maternal and fetal no-effect exposure levels in the rat (43.2 µg/m2/day) and rabbit (17.6 µg/m2/day) studies are approximately equal to the expected human systemic exposure level (18.5 µg/m2/day) from dermal application. There are no adequate and well-controlled studies in pregnant women. Therefore, Dovonex® (calcipotriene ointment) ointment should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Nursing Mothers It is not known whether calcipotriene is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when Dovonex® (calcipotriene ointment), 0.005% is administered to a nursing woman. Pediatric Use Safety and effectiveness of Dovonex® (calcipotriene ointment) in pediatric patients have not been established. Because of a higher ratio of skin surface area to body mass, pediatric patients are at greater risk than adults of systemic adverse effects when they are treated with topical medication. Geriatric Use Of the total number of patients in clinical studies of calcipotriene ointment, approximately 12% were 65 or older, while approximately 4% were 75 and over. The results of an analysis of severity of skin-related adverse events showed a statistically significant difference for subjects over 65 years (more severe) compared to those under 65 years (less severe). Last reviewed on RxList: 5/6/2008
This monograph has been modified to include the generic and brand name in many instances.

Source: http://www.rxlist.com

Health Services in

Drug Database Online

Welcome to Women's Health Care an online drug guide and dictionary, here you can get drug information and definitaions for most popular pharmaceutical and medicinal drugs, and specifically Dovonex Ointment. Find what medications you are taking today.