Frequently asked Questions
What is Taclonex® Ointment? Taclonex®
Ointment is a prescription medicine that is for use on the skin only (a topical
medicine). Taclonex® Ointment is used to treat psoriasis vulgaris
in adults 18 years of age and older. Taclonex® Ointment is not recommended
for use in children. Taclonex® Ointment has not been studied in patients
under the age of 18.
Who should not use Taclonex® Ointment?
Do not use Taclonex® Ointment if you:
- have a calcium metabolism disorder
- have one of the following types of psoriasis:
- erythrodermic psoriasis
- exfoliative psoriasis
- pustular psoriasis
- have severe kidney or liver disease
- are allergic to anything in Taclonex® Ointment. See below for a complete list of ingredients.
What should I tell my doctor before using Taclonex®
Ointment? Tell your doctor about all of your health conditions, including
- have a skin infection. Your skin infection should be treated before starting
- have thin-skin (atrophy) at the site to be treated. You should not use Taclonex®
- are getting phototherapy treatments (light therapy) for your psoriasis.
- are pregnant or planning to become pregnant. It is not known if Taclonex®
Ointment can harm your unborn baby. You and your doctor will have to decide if Taclonex®
Ointment is right for you while pregnant.
- are breastfeeding. It is not known if Taclonex® Ointment passes
into your milk and if it can harm your baby.
Tell your doctor about all the medicines you take, including prescription, and nonprescription
medicines, vitamins and herbal supplements. Taclonex® Ointment
and some other medicines can interact with each other. Especially tell your doctor
if you use:
How should I use Taclonex® Ointment?
- other corticosteroid medicines
- other medicines for your psoriasis
- Use Taclonex® Ointment exactly as prescribed by your doctor.
- Do not use more than the maximum recommended weekly amount of 100 grams of Taclonex®
- Apply Taclonex® Ointment once a day to the areas of your skin affected
by psoriasis. Gently rub Taclonex® Ointment into your affected skin
- Only use Taclonex® Ointment as directed by your doctor. Taclonex®
Ointment is recommended for up to 4 weeks of treatment. Do not use Taclonex®
Ointment for more than 4 weeks unless prescribed by your doctor.
- Do not use Taclonex® Ointment on the face, under arms or on groin
area. If you accidentally get Taclonex® Ointment on the face or in
the eyes wash the area with water right away.
- If you forget to use Taclonex® Ointment, use it as soon as you remember.
Then go on as before.
- Wash your hands well after applying Taclonex® Ointment.
- Do not bandage or tightly cover the treated skin area.
- Remove the cap and check that the aluminum seal covers the tube before the first
use. To break the seal, turn the cap over and punch through the seal.
What should I avoid while using Taclonex®
Ointment? Avoid spending a long time in the sunlight. Avoid tanning booths
and sunlamps. Use sunscreen if you have to be in the sunlight. Talk
to your doctor if you get a sunburn.
What are the possible side effects of Taclonex®
Ointment? The most common side effects are:
Other less common side effects with Taclonex® Ointment include:
- redness of the skin
- skin irritation
- skin burning
- inflamed hair pores (folliculitis)
- change of skin color (at the site of application)
- rash with pus-filled papules
- thinning of the skin (atrophy)
- swollen fine blood vessels (this makes your skin appear red at the site of application)
Taclonex® Ointment may cause serious side effects. Serious
side effects are more likely to happen if you use too much Taclonex®
Ointment, use it for too long, or use it with other topical medicines that contain
corticosteroids, calcipotriene, or certain other ingredients. Check with your doctor
before using other topical medicines. Taclonex® Ointment can pass
through your skin. Serious side effects may include:
- too much calcium in your blood or urine
- adrenal gland problems
Your doctor may do special blood and urine tests to check your calcium levels and
adrenal gland function while you are using Taclonex® Ointment. Call
your doctor about any side effect that bothers you or that does not go away.
These are not all of the side effects with Taclonex® Ointment. Ask
your doctor or pharmacist for more information.
How should I store Taclonex® Ointment?
- Store Taclonex® Ointment between 68–77° F (20–25° C); excursions
59–86° F (15–30° C).
- Make sure the cap on the tube is tightly closed.
- Taclonex® Ointment has an expiration date (exp.) marked on the tube.
Do not use the ointment after this date.
- Keep Taclonex® Ointment and all medicines out of the reach of
children and pets.
What are the ingredients in Taclonex® Ointment?
Active ingredients: calcipotriene hydrate, betamethasone dipropionate.
ingredients: mineral oil, PPG-15 stearyl ether, dl-alpha tocopherol, white petrolatum.
Another product, Taclonex Scalp® (calcipotriene 0.005% and betamethasone
dipropionate 0.064%) Topical Suspension, contains the same medicine that is in Taclonex®
Ointment and is used to treat psoriasis vulgaris on the scalp. If you use both medicines
to treat your psoriasis vulgaris, be sure to follow your doctor’s directions carefully
so that you do not use too much of one or both of these medications.
INDICATIONS AND USAGE
Taclonex® Topical Suspension is indicated for the topical treatment of plaque psoriasis of the scalp and body in patients 18 years and older. Apply Taclonex® Topical Suspension to affected areas once daily for up to 8 weeks. Treatment may be discontinued earlier, if cleared. Instruct patients not to exceed a maximum weekly dose of 100 g.
Taclonex® (calcipotriene 0.005% and betamethasone dipropionate 0.064%) Ointment
is approved for use on the skin to treat psoriasis vulgaris (plaque psoriasis) in
adults 18 years of age and older and should be applied to affected areas once daily
for up to 4 weeks. Taclonex Scalp® (calcipotriene 0.005% and betamethasone dipropionate
0.064%) Topical Suspension is approved to treat moderate to severe psoriasis vulgaris
of the scalp in adults 18 years and older and should be applied to affected areas
on the scalp once a day for 2 weeks or until cleared. If the affected area is not
cleared, Taclonex Scalp® Topical Suspension may be continued for up to 8 weeks.
Do not exceed the recommended weekly dose of 100 grams for either product. Neither
product is recommended for use on children.
IMPORTANT SAFETY INFORMATION ABOUT TACLONEX® TOPICAL SUSPENSION, TACLONEX® OINTMENT, AND TACLONEX SCALP® TOPICAL
FOR TOPICAL USE ONLY. Taclonex® Topical Suspension is not for oral, ophthalmic, or intravaginal use and should not be applied to the face, axillae, or groin. Do not use if atrophy is present at the treatment site.
Hypercalcemia and hypercalciuria have been observed with use of Taclonex® Topical Suspension. If hypercalcemia or hypercalciuria develop, discontinue treatment until parameters of calcium metabolism have normalized. Systemic absorption of topical corticosteroids can produce reversible hypothalamic-pituitary-adrenal (HPA) axis suppression with the potential for clinical glucocorticosteroid insufficiency. Use of topical corticosteroids may require that patients be periodically evaluated for HPA axis suppression and calcium abnormalities. If HPA axis suppression is documented, attempt to withdraw the drug, reduce the frequency of application, or substitute a less potent steroid. Cushing’s syndrome, hyperglycemia, and unmasking of latent diabetes mellitus can also result from systemic absorption of topical corticosteroids.
In clinical trials, the most common adverse reactions that occurred in ≥1% of subjects treated with Taclonex® Topical Suspension and at a rate higher than in subjects treated with vehicle were folliculitis and burning sensation of skin. Other less common adverse reactions (<1% but >0.1%) were, in decreasing order of incidence: acne, exacerbation of psoriasis, eye irritation, and pustular rash. Local adverse reactions may include atrophy, striae, telangiectasias, burning, itching, irritation, dryness, folliculitis, acneiform eruptions, hypopigmentation, perioral dermatitis, allergic contact dermatitis, secondary infection, and miliaria and may be more likely with occlusive use or more potent corticosteroids. Some local adverse reactions may be irreversible.
Taclonex® Topical Suspension may cause eye irritation. Avoid eye exposures. Patients who apply Taclonex® Topical Suspension to exposed skin should avoid excessive exposure to either natural or artificial sunlight, including tanning booths, sun lamps, etc. There are no adequate and well-controlled studies of Taclonex® Topical Suspension in pregnant women. Taclonex® Topical Suspension should be used during pregnancy only if the potential benefit to the patient justifies the potential risk to the fetus. Because many drugs are excreted in human milk, caution should be exercised when Taclonex® Topical Suspension is administered to a nursing woman. The patient should be instructed not to use Taclonex® Topical Suspension on the breast when nursing. Safety and effectiveness of the use of Taclonex® Topical Suspension in pediatric patients have not been studied.
FOR TOPICAL USE ONLY. Do not use Taclonex® Ointment or Taclonex Scalp® Topical
Suspension on your face, under your arms, or on your groin. Do not get either product
in your eyes, mouth, or vaginal area. Do not swallow Taclonex® Ointment or Taclonex
Scalp® Topical Suspension.
You should not use Taclonex® Ointment or Taclonex Scalp® Topical Suspension if you
are allergic to any of their ingredients, have thin skin (atrophy) at the treatment
site, have known or suspected calcium metabolism disorders (too much or too little
calcium in your blood or urine), have erythrodermic, exfoliative, or pustular psoriasis,
or have severe kidney or severe liver disease. Avoid excessive exposure to either
natural or artificial sunlight if you apply Taclonex® Ointment to exposed portions
of your body or use Taclonex Scalp® Topical Suspension. Tell your doctor if you
have a skin infection, are getting phototherapy treatments for your psoriasis, are
pregnant, or planning to become pregnant, or are breastfeeding. Also tell your doctor
about other medicines you are taking, especially other corticosteroids, products
containing calcipotriene, or medicines for your psoriasis.
Taclonex® Ointment and Taclonex Scalp® Topical Suspension may cause serious side
effects if you use too much, use it for too long, or use it with other medicines
that contain corticosteroids or calcipotriene. Taclonex® Ointment and Taclonex
Scalp® Topical Suspension contain the same medicine to treat psoriasis vulgaris.
If you use both medicines to treat your psoriasis vulgaris, be sure to follow your
doctor’s directions carefully so that you do not use too much of one or both of
these medicines. Taclonex® Ointment and Taclonex Scalp® Topical Suspension can pass
through your skin. Serious side effects may include too much calcium in your blood
or urine or adrenal gland problems. Your doctor may do special blood and urine tests
to check your calcium levels and adrenal gland function while you are using Taclonex®
Ointment or Taclonex Scalp® Topical Suspension.
The most common side effects of Taclonex® Ointment are itching and rash. Other less
common side effects with Taclonex® Ointment include redness of the skin, inflamed
hair pores (folliculitis), psoriasis, skin irritation, skin burning, change of skin
color (at the site of application), rash with pus-filled papules, thinning of the
skin, and swollen fine blood vessels (this makes your skin appear red at the site
The most common side effects of Taclonex Scalp® Topical Suspension are inflamed
hair pores (folliculitis) and burning sensation of the skin. Other side effects
include itching, worsening of psoriasis, redness of the skin, and skin pain or irritation.
You are encouraged to report negative side effects of prescription drugs to the FDA.
Visit www.accessdata.fda.gov/scripts/medwatch/medwatch-online.htm or call 1-800-FDA-1088.
Please see full Prescribing Information for
Taclonex® Topical Suspension,
Taclonex® Ointment, and
Taclonex Scalp® Topical Suspension.
The health information contained on this Web site is provided for educational purposes only and is not intended to replace discussions with a healthcare professional. All decisions regarding patient care must be made with a healthcare professional.
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