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Dovonex
Overview
What is Dovonex?
Dovonex (calcipotriene solution) Scalp
Solution, 0.005% is a colorless topical solution containing calcipotriene
monohydrate, a synthetic vitamin D derivative, for
topical dermatologic use.
Calcipotriene monohydrate is a white or off-white crystalline substance.
Dovonex Scalp Solution contains calcipotriene
monohydrate equivalent to 50 μg/g anhydrous calcipotriene in a vehicle of
isopropanol (51% v/v), propylene glycol, hydroxypropyl cellulose, sodium
citrate, menthol and water.
What does Dovonex look like?
What are the available doses of Dovonex?
Sorry No records found.
What should I talk to my health care provider before I take Dovonex?
Sorry No records found
How should I use Dovonex?
Dovonex (calcipotriene solution) Scalp Solution,
0.005%, is indicated for the topical treatment of chronic, moderately severe
psoriasis of the scalp. The safety and effectiveness of topical calcipotriene in
dermatoses other than psoriasis have not been established.
Comb the hair to remove scaly debris and after suitably parting,
apply Dovonex Scalp Solution, 0.005%, twice daily, only
to the lesions, and rub in gently and completely, taking care to prevent the
solution spreading onto the forehead. The safety and efficacy of Dovonex Scalp Solution, 0.005%, have been demonstrated in patients
treated for eight weeks.
Keep Dovonex Scalp Solution, 0.005%,
well away from the eyes
Always wash hands thoroughly after use.
What interacts with Dovonex?
Dovonex Scalp Solution, 0.005%, is contraindicated in those patients with acute psoriatic eruptions or 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.
What are the warnings of Dovonex?
Lithium generally should not be given with diuretics (see ).
Avoid contact with the eyes or mucous membranes. Discontinue use
if a sensitivity reaction occurs or if excessive irritation develops on
uninvolved skin areas.
Drug product is flammable. Keep away from open flame.
What are the precautions of Dovonex?
Sorry No Records found
What are the side effects of Dovonex?
In controlled clinical trials, the most frequent adverse reactions reported to
be related to Dovonex Scalp Solution, 0.005%, use were
transient burning, stinging and tingling, which occurred in approximately 23% of
patients. Rash was reported in about 11% of patients. Dry skin, irritation and
worsening of psoriasis were reported in 1-5% of patients. Skin atrophy,
hyperpigmentation, hypercalcemia, and folliculitis were not observed in these
studies, but cannot be excluded.
What should I look out for while using Dovonex?
Dovonex Scalp Solution, 0.005%, is contraindicated in
those patients with acute psoriatic eruptions or 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.
Avoid contact with the eyes or mucous membranes. Discontinue use
if a sensitivity reaction occurs or if excessive irritation develops on
uninvolved skin areas.
Drug product is flammable. Keep away from open flame.
What might happen if I take too much Dovonex?
Topically applied calcipotriene can be absorbed in sufficient amounts to produce
systemic effects. Elevated serum calcium has been observed with excessive use of
topical calcipotriene. If elevation in serum calcium should occur, discontinue
treatment until normal calcium levels are restored. (See .)
How should I store and handle Dovonex?
Store bottles of 1000 SINGULAIR 5-mg chewable tablets and 8000 SINGULAIR 10-mg film-coated tablets at 25°C (77°F), excursions permitted to 15-30°C (59-86°F) [see USP Controlled Room Temperature]. Protect from moisture and light. Store in original container. When product container is subdivided, repackage into a well-closed, light resistant container. Dovonex (calcipotriene solution) Scalp Solution, 0.005% is available in 60 mL plastic bottles, NDC 54868-6057-0STORAGEStore at controlled room temperature 15° C - 25° C (59° F - 77° F). Avoid sunlight. Do not freeze.Dovonex (calcipotriene solution) Scalp Solution, 0.005% is available in 60 mL plastic bottles, NDC 54868-6057-0STORAGEStore at controlled room temperature 15° C - 25° C (59° F - 77° F). Avoid sunlight. Do not freeze.Dovonex (calcipotriene solution) Scalp Solution, 0.005% is available in 60 mL plastic bottles, NDC 54868-6057-0STORAGEStore at controlled room temperature 15° C - 25° C (59° F - 77° F). Avoid sunlight. Do not freeze.
Clinical Information
Chemical Structure
No Image foundClinical Pharmacology
In humans, the natural supply of vitamin D depends mainly on
exposure to the ultraviolet rays of the sun for conversion of
7-dehydrocholesterol to vitamin D (cholecalciferol) in
the skin. Calcipotriene is a synthetic analog of vitamin D.
Although the precise mechanism of calcipotriene’s antipsoriatic action is not
fully understood, evidence suggests that
calcipotriene is roughly equipotent to the natural vitamin in its effects on
proliferation and differentiation of a variety of cell types. Calcipotriene has
also been shown, in animal studies, to be 100-200 times less potent in its
effects on calcium utilization than the natural hormone.
Clinical studies with radiolabelled calcipotriene solution indicate that less
than 1% of the applied dose of calcipotriene is absorbed through the scalp when
the solution (2.0 mL) is applied topically to normal skin or psoriasis plaques
(160 cm) for 12 hours, and that much of the absorbed
calcipotriene is converted to inactive metabolites within 24 hours of
application.
Vitamin D and its metabolites are transported in the blood, bound to specific
plasma proteins. The active form of the vitamin, 1,25-dihydroxy vitamin D (calcitriol), is known to be recycled via the liver and
excreted in the bile. Calcipotriene metabolism following systemic uptake is
rapid, and occurs via a similar pathway to the natural hormone. The primary
metabolites are much less potent than the parent compound.
There is evidence that maternal 1,25-dihydroxy vitamin D (calcitriol) may enter the fetal circulation, but it is not
known whether it is excreted in human milk. The systemic disposition of
calcipotriene is expected to be similar to that of the naturally occurring
vitamin.
Non-Clinical Toxicology
Dovonex Scalp Solution, 0.005%, is contraindicated in those patients with acute psoriatic eruptions or 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.Avoid contact with the eyes or mucous membranes. Discontinue use if a sensitivity reaction occurs or if excessive irritation develops on uninvolved skin areas.
Drug product is flammable. Keep away from open flame.
When given concurrently the following drugs may interact with thiazide diuretics.
General
Use of Dovonex Scalp Solution, 0.005%, may cause transient irritation of both lesions and surrounding uninvolved skin. If irritation develops, Dovonex Scalp Solution, 0.005%, should be discontinued.
For external use only. Keep out of the reach of children. Always wash hands thoroughly after use.
Reversible elevation of serum calcium has occurred with use of topical calcipotriene. If elevation in serum calcium outside the normal range should occur, discontinue treatment until normal calcium levels are restored.
Patients using Dovonex Scalp Solution, 0.005%, should receive the following information and instructions:
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/m/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 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 limit or 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/m/day) of calcipotriene indicated no impairment of fertility or general reproductive performance.
Studies of teratogenicity were done by the oral route where bioavailability is expected to be approximately 40-60% of the administered dose. Increased rabbit maternal and fetal toxicity was noted at 12 μg/kg/day (132 μg/m/day). Rabbits administered 36 μg/kg/day (396 μg/m/day) resulted in fetuses with a significant increase in the incidences of pubic bones, forelimb phalanges, and incomplete bone ossification. In a rat study, oral doses of 54 μg/kg/day (318 μg/m/day) resulted in a significantly higher incidence of skeletal abnormalities consisting primarily of enlarged fontanelles and extra ribs. The enlarged fontanelles are most likely due to calcipotriene's effect upon calcium metabolism. The maternal and fetal calculated no-effect exposures in the rat (43.2 μg/m/day) and rabbit (17.6 μg/m/day) studies are greater than the expected human systemic exposure level (0.13 μg/m/day) from dermal application. There are no adequate and well-controlled studies in pregnant women. Therefore, Dovonex Scalp Solution, 0.005%, should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.
There is evidence that maternal 1,25-dihydroxy vitamin D (calcitriol) may enter the fetal circulation, but it is not known whether it is excreted in human milk. The systemic disposition of calcipotriene is expected to be similar to that of the naturally occurring vitamin. Because many drugs are excreted in human milk, caution should be exercised when Dovonex (calcipotriene solution) Scalp Solution, 0.005%, is administered to a nursing woman.
Safety and effectiveness of Dovonex Scalp Solution, 0.005%, in pediatric patients have not been specifically 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.
Of the total number of patients in clinical studies of calcipotriene solution, approximately 16% were 65 or older, while approximately 4% were 75 and over. The results of an analysis of severity of skin-related adverse events showed no differences for subjects over 65 years compared to those under 65 years, but greater sensitivity of some older individuals cannot be ruled out.
In controlled clinical trials, the most frequent adverse reactions reported to be related to Dovonex Scalp Solution, 0.005%, use were transient burning, stinging and tingling, which occurred in approximately 23% of patients. Rash was reported in about 11% of patients. Dry skin, irritation and worsening of psoriasis were reported in 1-5% of patients. Skin atrophy, hyperpigmentation, hypercalcemia, and folliculitis were not observed in these studies, but cannot be excluded.
Reference
This information is obtained from the National Institute of Health's Standard Packaging Label drug database.
"https://dailymed.nlm.nih.gov/dailymed/"
While we update our database periodically, we cannot guarantee it is always updated to the latest version.
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