calcipotriene (Topical route)

kal-si-poe-TRYE-een

Commonly used brand name(s):

In the U.S.

• Dovonex

Available Dosage Forms:

• Cream
• Ointment
• Solution

Therapeutic Class: Antipsoriatic

Pharmacologic Class: Vitamin D3, Synthetic

Uses For calcipotriene

Calcipotriene is used to treat psoriasis. It works by controlling the overproduction of skin cells in areas affected by psoriasis.

Calcipotriene is available only with your doctor's prescription.

Before Using calcipotriene

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For calcipotriene, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to calcipotriene or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

calcipotriene has been tested in a limited number of children 2 to 14 years of age with psoriasis on less than 30% of the body. When used for 8 weeks or less, the medicine has not been shown to cause different side effects or problems than it does in adults. However, more studies are needed.

Geriatric

Skin-related side effects caused by calcipotriene may be more severe when they occur in patients over 65 years of age.

Pregnancy

Breast Feeding

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Interactions with Medicines

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. Tell your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other Medical Problems

The presence of other medical problems may affect the use of calcipotriene. Make sure you tell your doctor if you have any other medical problems, especially:

• Highly irritated areas of psoriasis on the scalp—Calcipotriene topical solution may increase the skin irritation because of the alcohol in the product.

• Hypercalcemia (high blood levels of calcium) or
• Hypercalciuria (high urine levels of calcium) or
• Hypervitaminosis D (high blood levels of vitamin D)—You should not use calcipotriene. It may increase the chance of kidney stone formation.

• Kidney stones (or history of)—Calcipotriene may make this condition worse.

Proper Use of calcipotriene

Calcipotriene is for external use only. Do not use calcipotriene orally and do not apply it in your vagina. Use calcipotriene only as directed. Do not use more of it, do not use it more often, and do not use it for a longer time than your doctor ordered. To do so may increase the chance of side effects.

To help clear up your skin problem completely, it is very important that you keep using calcipotriene for the full time of treatment. Do not miss any doses.

Unless otherwise directed by your doctor, do not use more than 100 grams of calcipotriene ointment or cream in 1 week (that is, one 100-gram tube or three 30-gram tubes or six 15-gram tubes in 1 week). Do not use more than 60 milliliters of the topical solution for the scalp in 1 week.

Do not use calcipotriene on your face, near the eyes, inside your nose or mouth, or on unaffected areas of the skin. If you accidentally get some on these areas, wash it off with water right away.

Use calcipotriene sparingly in the folds of your skin because it is more likely to cause irritation there.

Wash your hands after using calcipotriene to avoid accidentally getting the medicine on your face or on unaffected areas of the skin.

Do not use calcipotriene for treating skin problems other than the one for which it was prescribed by your doctor.

For cream and ointment dosage forms:

• Apply enough medicine to cover the areas of your skin affected by psoriasis and rub in gently and well. The treated areas should not be covered (for instance, with a bandage or plastic wrap) after the medicine is applied.
• If you are being treated with calcipotriene ointment in combination with ultraviolet light (found in sunlight and some special lamps), do not apply the morning dose of calcipotriene before being treated with the ultraviolet light. It can be applied afterwards.

For solution dosage form:

• Before applying the medicine to your scalp, comb your dry hair to remove any flakes, then part your hair so that you can see the scalp lesions. Apply the solution to the lesions and rub it in gently but completely. Do not apply the medicine if the lesions are very irritated because the alcohol in the product may make the irritation worse. Try not to get any medicine on your forehead.

Dosing

The dose of calcipotriene will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of calcipotriene. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

The length of time you use the medicine depends on the severity of your psoriasis.

• For topical dosage form (cream):
  • For psoriasis:
    • Adults—Apply to the affected area(s) of the skin two times a day, in the morning and evening. Treatment may be continued for six to eight weeks or as determined by your doctor.
    • Children—Use and dose must be determined by your doctor.
• For topical dosage form (ointment):
  • For psoriasis:
    • Adults—Apply to the affected area(s) of the skin one or two times a day, in the morning and evening. Treatment may be continued for six to eight weeks or as determined by your doctor.
    • Children—Use and dose must be determined by your doctor.
• For topical dosage form (solution):
  • For psoriasis:
    • Adults—Apply to the affected area(s) of the scalp two times a day, in the morning and evening. Treatment may be continued for six to eight weeks or as determined by your doctor.
    • Children—Use and dose must be determined by your doctor.

Missed Dose

If you miss a dose of calcipotriene, apply it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule.

Storage

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Keep the topical solution away from open flame.

Precautions While Using calcipotriene

Calcipotriene may cause irritation of the affected area(s) of your skin for a short time after you have applied it. Sometimes it may also cause irritation of the surrounding normal skin. If this happens, try not to scratch the area.

If the irritation continues, if you develop rash on your face, or if the medicine causes any other problems for you, stop using the medicine and check with your doctor.

You may have to see your doctor regularly while using calcipotriene so that your doctor can check for any side effects, especially an increase in the level of calcium in your blood or urine, because this may lead to kidney stone formation.

Your doctor may tell you when you should expect to notice an improvement in your condition (usually within 2 to 8 weeks). If your condition has not improved by then or if it becomes worse, check with your doctor.

Calcipotriene may cause your skin to be more sensitive to sunlight than it is normally. Exposure to sunlight, even for brief periods of time, may cause a skin rash, itching, redness, or other discoloration of the skin, or a severe sunburn. When you begin taking calcipotriene:

• Stay out of direct sunlight, especially between the hours of 10:00 a.m. and 3:00 p.m., if possible
• Wear protective clothing, including a hat. Also, wear sunglasses.
• Apply a sunblock product that has a skin protection factor (SPF) number, especially if you have a fair complexion. If you have any questions about this, check with your health care professional
• Do not use a sun lamp or tanning bed or booth.

If you have a severe reaction from the sun, check with your doctor.

calcipotriene Side Effects

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor as soon as possible if any of the following side effects occur:

• Redness and swelling of skin with itching
• skin rash
• worsening of psoriasis, including spreading to the face and scalp

• Abdominal or stomach pain, constipation, depression, loss of appetite, loss of weight, muscle weakness, nausea, thirst, tiring easily, and vomiting
• burning, itching, and pain in hairy areas
• pus in the hair follicles
• thinning, weakness, or wasting away of skin

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

• Burning, dryness, irritation, peeling, or redness of skin

• Darkening of treated areas of skin

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

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

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