Drugs Details

Drugs Info of Calcitrene, Dovonex, Sorilux
Drugs Details
  • Drugs Type  : FDA
  • Date : 23rd Jan 2015 03:27 am
  • Brand Name : Calcitrene, Dovonex, Sorilux
  • Generic Name : calcipotriene topical (Pronunciation: cal sih poh TRY een)
Descriptions

Dovonex® (calcipotriene) Cream, 0.005% contains calcipotriene monohydrate, a synthetic vitamin D3 derivative, for topical dermatological use.

Chemically, calcipotriene monohydrate is (5Z,7E,22E,24S)-24-cyclopropyl-9,10-secochola-5,7,10(19), 22-tetraene-1a,3b,24-triol monohydrate, with the empirical formula C27H40O3†H2O, a molecular weight of 430.6, and the following structural formula:

Calcipotriene monohydrate is a white or off-white crystalline substance. Dovonex Cream (calcipotriene cream) contains calcipotriene monohydrate equivalent to 50 µg/g anhydrous calcipotriene in a cream base of cetearyl alcohol, ceteth-20, diazolidinyl urea, dichlorobenzyl alcohol, dibasic sodium phosphate, edetate disodium, glycerin, mineral oil, petrolatum, and water.

What are the possible side effects of calcipotriene topical (Calcitrene, Dovonex, Sorilux)?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Stop using calcipotriene topical and call your doctor at once if you have a serious side effect such as:

  • severe burning, stinging, or irritation after using this medication;
  • worsening of your skin condition; or
  • nausea, vomiting, stomach pain, loss of appetite, constipation, increased thirst or urination, muscle pain or weakness, joint pain, confusion, and feeling...

Read All Potential Side Effects and See Pictures of Dovonex Cream »

What are the precautions when taking calcipotriene cream (Dovonex Cream)?

Before using this medication, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

This medication should not be used if you have certain medical conditions. Before using this medicine, consult your doctor or pharmacist if you have: high calcium/vitamin D levels (hypercalcemia/hypervitaminosis D).

Before using this medication, tell your doctor or pharmacist your medical history.

This medication may make you more sensitive to the sun. Avoid prolonged sun exposure, tanning booths, and sunlamps. Use a sunscreen and wear protective clothing when outdoors. Your doctor may direct you to...

Read All Potential Precautions of Dovonex Cream »


This monograph has been modified to include the generic and brand name in many instances.

Indications

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

Dosage Administration

Apply a thin layer of Dovonex Cream (calcipotriene cream) to the affected skin twice daily and rub in gently and completely. The safety and efficacy of Dovonex Cream (calcipotriene cream) have been demonstrated in patients treated for eight weeks.

How Supplied

Dovonex® (calcipotriene cream) Cream, 0.005% is available in:

60 gram aluminum tubes (NDC 0072-0260-06) 120 gram aluminum tubes (NDC 0072-0260-12)

STORAGE

Store at controlled room temperature 15° C-25° C (59° F-77° F). Do not freeze.

Manufactured by Leo Laboratories Ltd., Dublin, Ireland
Bristol-Myers Squibb Company
Distributed by: Bristol-Myers Squibb Company., Princeton, NJ 08543 USA
U.S. Patent No. 4,866,048 FDA
Rev date: 4/28/05


This monograph has been modified to include the generic and brand name in many instances.

 

Side Effects

In controlled clinical trials, the most frequent adverse experiences reported for Dovonex (calcipotriene cream) Cream, 0.005% were cases of skin irritation, which occurred in approximately 10-15% of patients. Rash, pruritus, dermatitis and worsening of psoriasis were reported in 1 to 10% of patients.

Read the Dovonex Cream (calcipotriene cream) Side Effects Center for a complete guide to possible side effects

Interactions

No information provided.


This monograph has been modified to include the generic and brand name in many instances.

Warnings

No information provided.

Precautions

General

Use of Dovonex Cream may cause transient irritation of both lesions and surrounding uninvolved skin. If irritation develops, Dovonex Cream (calcipotriene cream) 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.

Carcinogenesis, Mutagenesis, Impairment of Fertility

The potential of calcipotriene to induce carcinogenesis in standard long-term animal studies (in the absence of ultra-violet radiation (UVR)) has not been evaluated. 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 |ig/kg/day (318 |lg/m /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. Increased rabbit maternal and fetal toxicity was noted at 12 |ig/kg/day (132 |lg/m /day). Rabbits administered 36 |ig/kg/day (396 |lg/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 |ig/kg/day (318 |ig/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/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 Cream (calcipotriene cream) should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

Nursing Mothers

There is evidence that maternal 1,25-dihydroxy vitamin D3 (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 Cream (calcipotriene cream) is administered to a nursing woman.

Pediatric Use

Safety and effectiveness of Dovonex Cream (calcipotriene cream) 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 cream, approximately 15% were 65 or older, while approximately 3% were 75 and over. There were no significant differences in adverse events for subjects over 65 years compared to those under 65 years of age. However, the greater sensitivity of older individuals cannot be ruled out.


This monograph has been modified to include the generic and brand name in many instances.

OverDose

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 PRECAUTIONS.)

ContrainDications

Dovonex Cream 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 Cream (calcipotriene cream) should not be used on the face.


This monograph has been modified to include the generic and brand name in many instances.

Clinical Pharamacology

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 D3 (cholecalciferol) in the skin. Calcipotriene is a synthetic analog of vitamin D3.

Clinical studies with radiolabelled calcipotriene ointment indicate that approximately 6% (± 3%, SD) of the applied dose of calcipotriene is absorbed systemically when the ointment is applied topically to psoriasis plaques, or 5% (± 2.6%, SD) when applied to normal skin, and much of the absorbed active is converted to inactive metabolites within 24 hours of application. Systemic absorption of the cream has not been studied.

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 D3 (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.

CLINICAL STUDIES

Adequate and well-controlled trials of patients treated with Dovonex Cream (calcipotriene cream) have demonstrated improvement usually beginning after 2 weeks of therapy. This improvement continued with approximately 50% of patients showing at least marked improvement in the signs and symptoms of psoriasis after 8 weeks of therapy, but only approximately 4% showed complete clearing.


This monograph has been modified to include the generic and brand name in many instances.

Patient Information

Patients using Dovonex Cream should receive the following information and instructions:

1.    This medication is to be used only as directed by the physician. It is for external use only. Avoid contact with the face or eyes. As with any topical medication, patients should wash their hands after application.

2.    This medication should not be used for any disorder other than that for which it was prescribed.

3.   Patients should report to their physician any signs of adverse reactions.

4.   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.)


This monograph has been modified to include the generic and brand name in many instances.

Consumer Overview Uses

IMPORTANT: HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.

 

CALCIPOTRIENE - TOPICAL

 

(KAL-si-poe-TRYE-een)

 

COMMON BRAND NAME(S): Dovonex, Sorilux

 

USES: This medication is used to treat psoriasis. Calcipotriene is a form of vitamin D. It works by slowing down the growth of skin cells.

 

HOW TO USE: Use this medication on the skin only. Apply a thin layer of the medication as directed by your doctor to the affected area and gently rub in, usually once or twice daily for the ointment or twice daily for the cream or the foam. Wash your hands after using, unless you are using this medication to treat the hands. Do not apply the medication on the face, in the eyes, nose, or mouth, or inside the vagina. If you do get the medication in those areas, flush with plenty of water.

Do not apply more often or use longer than prescribed. This may increase the risk of side effects.

Use this medication regularly to get the most benefit from it. To help you remember, use it at the same time(s) each day.

Inform your doctor if your condition does not improve or if it worsens. You should usually begin to see an improvement in your skin condition after 2 weeks of treatment.

Consumer Overview Side Effect

SIDE EFFECTS: Burning, itching, rash, irritation, redness, dry skin, or peeling at the application site may occur. If any of these effects persist or worsen, notify your doctor or pharmacist promptly.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor immediately if any of these unlikely but serious side effects occur: skin thinning/discoloration, stretch marks, "hair bumps" (folliculitis), unusual tiredness, mental/mood changes, unexplained constipation.

A very serious allergic reaction to this drug is rare. However, seek immediate medical attention if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

 

Read the Dovonex Cream (calcipotriene cream) Side Effects Center for a complete guide to possible side effects

Learn More »

PRECAUTIONS: Before using this medication, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

This medication should not be used if you have certain medical conditions. Before using this medicine, consult your doctor or pharmacist if you have: high calcium/vitamin D levels (hypercalcemia/hypervitaminosis D).

Before using this medication, tell your doctor or pharmacist your medical history.

This medication may make you more sensitive to the sun. Avoid prolonged sun exposure, tanning booths, and sunlamps. Use a sunscreen and wear protective clothing when outdoors. Your doctor may direct you to limit or avoid phototherapy while you use this medication. Discuss this further with your doctor.

Caution is advised when using this drug in the elderly because they may be more sensitive to the effects of the drug.

During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor.

It is not known whether this drug passes into breast milk. Consult your doctor before breast-feeding.

Consumer Overview Missed Dose

DRUG INTERACTIONS: Your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop, or change the dosage of any medicine before checking with them first.

Before using this medication, tell your doctor or pharmacist of all prescription and nonprescription/herbal products you may use, especially of: other products containing vitamin D.

This document does not contain all possible interactions. Therefore, before using this product, tell your doctor or pharmacist of all the products you use. Keep a list of all your medications with you, and share the list with your doctor and pharmacist.

 

OVERDOSE: This medicine may be harmful if swallowed. If swallowing or overdose is suspected, contact a poison control center or emergency room immediately. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center.

 

NOTES: Do not share this medication with others.

Laboratory and/or medical tests (e.g., calcium levels) may be performed periodically to monitor your progress or check for side effects. Consult your doctor for more details.

This medication has been prescribed for your current condition only. Do not use it later for another skin condition unless told to do so by your doctor. A different medication may be necessary in that case.

 

MISSED DOSE: If you miss a dose, use it as soon as you remember. If it is near the time of the next dose, skip the missed dose and resume your usual dosing schedule. Do not double the dose to catch up.

 

STORAGE: Store at room temperature away from light. Do not freeze. The foam is flammable. Avoid smoking during and right after applying the foam. Do not puncture the foam can or expose to high heat or open flame. Keep all medicines away from children and pets.

Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company for more details about how to safely discard your product.

 

Information last revised March 2013. Copyright(c) 2013 First Databank, Inc.

Patient Detailed Side Effect

Brand Names: Calcitrene, Dovonex, Sorilux

Generic Name: calcipotriene topical (Pronunciation: cal sih poh TRY een)

  • What is calcipotriene topical (Dovonex Cream)?
  • What are the possible side effects of calcipotriene topical (Dovonex Cream)?
  • What is the most important information I should know about calcipotriene topical (Dovonex Cream)?
  • What should I discuss with my healthcare provider before using calcipotriene topical (Dovonex Cream)?
  • How should I use calcipotriene topical (Dovonex Cream)?
  • What happens if I miss a dose (Dovonex Cream)?
  • What happens if I overdose (Dovonex Cream)?
  • What should I avoid while using calcipotriene topical (Dovonex Cream)?
  • What other drugs will affect calcipotriene topical (Dovonex Cream)?
  • Where can I get more information?

What is calcipotriene topical (Dovonex Cream)?

Calcipotriene is a man-made form of vitamin D. It is involved in the growth and development of skin cells.

Calcipotriene topical (for the skin) is used to treat plaque psoriasis (psoriasis with scaly patches).

Calcipotriene topical may also be used for purposes not listed in this medication guide.

What are the possible side effects of calcipotriene topical (Dovonex Cream)?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Stop using calcipotriene topical and call your doctor at once if you have a serious side effect such as:

  • severe burning, stinging, or irritation after using this medication;
  • worsening of your skin condition; or
  • nausea, vomiting, stomach pain, loss of appetite, constipation, increased thirst or urination, muscle pain or weakness, joint pain, confusion, and feeling tired or restless.

Less serious side effects may include:

  • mild skin redness;
  • dry or peeling skin; or
  • mild rash or itching.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Read the Dovonex Cream (calcipotriene cream) Side Effects Center for a complete guide to possible side effects

Learn More »

What is the most important information I should know about calcipotriene topical (Dovonex Cream)?

You should not use calcipotriene topical if you are allergic to it, or if you have high levels of calcium in your blood (hypercalcemia).

Before using calcipotriene topical, tell your doctor if you are receiving phototherapy (light treatments) for your psoriasis.

Avoid getting this medication on your face or in your eyes, mouth, or vagina. If this does happen, rinse with water.

Do not use calcipotriene topical to treat any skin condition that has not been checked by your doctor. Do not share this medication with other people, even if they have the same symptoms you have.

Side Effects Centers
  • Dovonex Ointment
  • Dovonex Cream
  • Dovonex Scalp

Patient Detailed How Take

What should I discuss with my healthcare provider before using calcipotriene topical (Dovonex Cream)?

You should not use calcipotriene topical if you are allergic to it, or if you have high levels of calcium in your blood (hypercalcemia).

To make sure you can safely take calcipotriene topical, tell your doctor if you are receiving phototherapy (light treatments) for your psoriasis.

FDA pregnancy category C. It is not known whether calcipotriene topical will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant while using this medication.

It is not known whether calcipotriene topical passes into breast milk or if it could harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby. Do not apply calcipotriene topical to your chest area if you are breast-feeding.

Do not give this medication to anyone under 18 years old without medical advice.

How should I use calcipotriene topical (Dovonex Cream)?

Use exactly as prescribed by your doctor. Do not use in larger or smaller amounts or for longer than recommended. Calcipotriene topical is usually applied once or twice a day. Follow the directions on your prescription label.

Do not use calcipotriene topical to treat any skin condition that has not been checked by your doctor. Do not share this medication with other people, even if they have the same symptoms you have.

This medication comes with patient instructions for safe and effective use. Follow these directions carefully. Ask your doctor or pharmacist if you have any questions.

Wash your hands before and after applying this medication, unless you are using it to treat a hand condition.

Clean and dry the area of skin where you will apply calcipotriene topical. Apply the medication only to the affected area.

Shake the foam (Sorilux) well just before you measure a dose.

It may take up to 2 weeks before your symptoms improve. Keep using the medication as directed and tell your doctor if your symptoms do not improve after 8 weeks of treatment.

Store at room temperature away from moisture and heat. Do not keep in a refrigerator or freezer.

Calcipotriene topical foam and solution are flammable. Avoid using near open flame, and do not smoke until the medicine has completely dried on your skin. Keep the medicine canister away from open flame or high heat, such as in a car on a hot day. The canister may explode if it gets too hot. Do not puncture or burn an empty inhaler canister.

Side Effects Centers
  • Dovonex Ointment
  • Dovonex Cream
  • Dovonex Scalp

Patient Detailed Avoid Taking

What happens if I miss a dose (Dovonex Cream)?

Apply the missed dose as soon as you remember. However, if it is almost time for your next dose, skip the dose you missed and apply only your next regularly scheduled dose.

What happens if I overdose (Dovonex Cream)?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Overdose symptoms may include severe forms of some of the side effects listed in this medication guide.

What should I avoid while using calcipotriene topical (Dovonex Cream)?

Avoid getting this medication on your face or in your eyes, mouth, or vagina. If this does happen, rinse with water. Do not use calcipotriene topical on sunburned, windburned, dry, chapped, irritated, or broken skin.

Avoid exposing treated skin areas to sunlight or tanning beds. Calcipotriene topical can make you sunburn more easily. Wear protective clothing when you are outdoors.

Avoid using other medications on the areas you treat with calcipotriene topical unless your doctor tells you to.

What other drugs will affect calcipotriene topical (Dovonex Cream)?

Tell your doctor about all other medicines you use, especially:

  • vitamin or mineral supplements that contain calcium or vitamin D.

This list is not complete and other drugs may interact with calcipotriene topical. Tell your doctor about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal products. Do not start a new medication without telling your doctor.

Where can I get more information?

Your pharmacist can provide more information about calcipotriene topical.


Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.

Every effort has been made to ensure that the information provided by Cerner Multum, Inc. ('Multum') is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Multum's drug information does not endorse drugs, diagnose patients or recommend therapy. Multum's drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

Copyright 1996-2013 Cerner Multum, Inc. Version: 2.01. Revision date: 8/13/2012.

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