Taclonex® Ointment contains calcipotriene hydrate and betamethasone dipropionate.

It is intended for topical use.

Calcipotriene hydrate is a synthetic vitamin D₃ analogue.

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

Calcipotriene hydrate is a white to almost white crystalline compound.

Betamethasone dipropionate is a synthetic corticosteroid.

Betamethasone dipropionate has the chemical name 9-fluoro-11(β),17,21-trihydroxy-16(β)-methylpregna-1,4-diene-3,20-dione17,21-dipropionate, with the empirical formula C₂₈H₃₇FO₇, a molecular weight of 504.6, and the following structural formula:

Betamethasone dipropionate is a white to almost white odorless powder.

Each gram of Taclonex® Ointment contains 52.18 mcg of calcipotriene hydrate (equivalent to 50 mcg of calcipotriene) and 0.643 mg of betamethasone dipropionate (equivalent to 0.5 mg of betamethasone) in an ointment base of mineral oil, PPG-15 stearyl ether, dl-alpha tocopherol and white petrolatum.

Last updated on RxList: 10/17/2007

Taclonex® Ointment is indicated for the topical treatment of psoriasis vulgaris in adults 18 years of age and above for up to 4 weeks. The maximum weekly dose should not exceed 100 g. Treatment of more than 30% body surface area is not recommended.

Taclonex® Ointment should not be applied to the face, axillae or groin.

Apply an adequate layer of Taclonex® Ointment to the affected area(s) once daily for up to 4 weeks. Taclonex® Ointment should be rubbed in gently and completely. The maximum weekly dose should not exceed 100 g. Treatment of more than 30% body surface area is not recommended. Taclonex® Ointment should not be applied to the face, axillae or groin.

Taclonex® Ointment (calcipotriene 0.005% and betamethasone dipropionate 0.064%) is available in 60 gram collapsible tubes (NDC 0430-3230-15).

Store Taclonex® Ointment between 20-25°C (68-77°F); excursions permitted between 15-30°C (59-86°F).

Keep out of reach of children.

Manufactured by: LEO Laboratories Ltd. (LEO Pharma) Dublin, Ireland. FDA Rev date: 9/25/2007

Last updated on RxList: 10/17/2007

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. The adverse reaction information from clinical trials does, however, provide a basis for identifying the adverse events that appear to be related to drug use and for approximating rates.

The data described below reflect exposure to Taclonex® Ointment in 2448 patients, including 1992 exposed for 4 weeks, and 289 exposed for 8 weeks. In the trials that included assessment of the effects of Taclonex® Ointment on calcium metabolism, such testing was done after 4 weeks of treatment. The effects of Taclonex® Ointment on calcium metabolism following treatment durations of longer than 4 weeks are not known (See PRECAUTIONS). The effects of Taclonex® Ointment on the HPA axis following treatment durations of longer than 4 weeks have not been adequately studied. Taclonex® Ointment was studied primarily in placebo- and active-controlled trials (N = 1176, and N = 1272, respectively). The population was 15-97 years old, 61% males and 39% females, mostly white (97%) and had a baseline disease severity ranging from mild to very severe. Most patients received once daily application, and the median weekly dose was 24.5 g.

The percentage of subjects reporting at least one adverse event was 27.1% in the Taclonex® Ointment group, 33.0% in the calcipotriene group, 28.3% in the betamethasone group, and 33.4% in the vehicle group.

	Taclonex® Ointment N=2448	Calcipotriene N=3197	Betamethasone dipropionate N=1164	Vehicle N=470
Any Adverse Event	663 (27.1)	1055 (33.0)	329 (28.3)	157 (33.4)
Preferred Term	# of subjects (%)
Pruritus	75 (3.1)	183 (5.7)	38 (3.3)	43 (9.1)
Headache	69 (2.8)	75 (2.3)	44 (3.8)	12 (2.6)
Nasopharyngitis	56 (2.3)	77 (2.4)	34 (2.9)	9 (1.9)
Psoriasis	30 (1.2)	47 (1.5)	14 (1.2)	5 (1.1)
Rash scaly	30 (1.2)	40 (1.3)	0 (0.0)	1 (0.2)
Influenza	23 (0.9)	34 (1.1)	14 (1.2)	6 (1.3)
Upper respiratory	20 (0.8)	19 (0.6)	12 (1.0)	3 (0.6)
tract infection	15 (0.6)	54 (1.7)	3 (0.3)	5 (1.1)
Erythema Application site	13 (0.5)	24 (0.8)	10 (0.9)	6 (1.3)
pruritus	11 (0.4)	60 (1.9)	8 (0.7)	5 (1.1)
Skin irritation	7 (0.3)	12 (0.4)	3 (0.3)	5 (1.1)
Pain Burning sensation	6 (0.2)	30 (0.9)	3 (0.3)	6 (1.3)

Adverse Events Reported by ≥ 1% of Subjects by Preferred Term

A lesional/perilesional adverse event was generally defined as an adverse event located ≤ 2 cm from the lesional border.

Lesional/Perilesional Adverse Events Reported by ≥ 1% of Subjects

	Taclonex® Ointment N=2448	Calcipotriene N=3197	Betamethasone dipropionate N=1164	Vehicle N=470
Any Adverse Event	213 (8.7)	419 (13.1)	85 (7.3)	76 (16.2)
Preferred Term	# of subjects (%)
Pruritus	69 (2.8)	170 (5.3)	31 (2.7)	41 (8.7)
Rash scaly	29 (1.2)	38 (1.2)	0 (0.0)	0 (0.0)
Application site pruritus	12 (0.5)	24 (0.8)	10 (0.9)	6 (1.3)
Erythema	9 (0.4)	36 (1.1)	2 (0.2)	4 (0.9)
Skin irritation	9 (0.4)	51 (1.6)	8 (0.7)	5 (1.1)
Burning sensation	6 (0.2)	25 (0.8)	3 (0.3)	5 (1.1)

For subjects who reported lesional/perilesional adverse events, the median time to onset was 7 days for Taclonex® Ointment, 7 days for calcipotriene, 5 days for betamethasone dipropionate, and 3 days for vehicle.

Other less common reactions (less than 1% but more than 0.1%) were, in decreasing order of incidence, folliculitis, rash papular, rash pustular, and skin hypopigmentation. Skin atrophy, telangiectasia and skin hyperpigmentation were reported infrequently (0.1%).

In a separate study, patients (N=207) with at least moderate disease severity were given Taclonex® Ointment intermittently on an “as needed” basis for up to 52 weeks. The median use was 15.4 g per week. The effects of Taclonex® Ointment on calcium metabolism were not studied and the effects on the HPA axis were not adequately studied. The following adverse reactions were reported by 1% or more of the patients: pruritus (7.2%), psoriasis (3.4%), skin atrophy (1.9%), folliculitis (1.4%), burning sensation (1.4%), skin depigmentation (1.4%), ecchymosis (1.0%), erythema (1.0%) and hand dermatitis (1.0%). One case of a serious flare-up of psoriasis was reported.

Development of pustular psoriasis has been reported as an adverse reaction during and following use of Taclonex® Ointment.

No information provided.

Last updated on RxList: 11/2/2007

No information provided.

General

Hypercalcemia has been observed with use of Taclonex® Ointment. If elevation of serum calcium outside the normal range occurs, discontinue treatment until normal calcium levels are restored. In the trials that included assessment of the effects of Taclonex® Ointment on calcium metabolism, such testing was done after 4 weeks of treatment. The effects of Taclonex® Ointment on calcium metabolism following treatment durations of longer than 4 weeks are not known.

Systemic absorption of topical corticosteroids has produced reversible hypothalamic-pituitary-adrenal (HPA) axis suppression, manifestations of Cushing's syndrome, hyperglycemia, and glucosuria in some patients. Conditions which augment systemic absorption include the application of the more potent steroids, use over large surface areas, prolonged use, and the addition of occlusive dressings. Use of more than one corticosteroid-containing product at the same time may increase total systemic glucocorticoid exposure. (See DOSAGE AND ADMINISTRATION).

Therefore, patients receiving a large dose of a potent topical steroid applied to a large surface area should be evaluated periodically for evidence of HPA axis suppression by using the Cosyntropin Stimulation Test. If HPA axis suppression is noted, an attempt should be made to withdraw the drug, to reduce the frequency of application, or to substitute a less potent steroid. Recovery of HPA axis function is generally prompt and complete upon discontinuation of the topical corticosteroid.

The use of Taclonex® Ointment has not been studied in patients with severe renal insufficiency or severe hepatic disorders.

HPA axis suppression has been observed with Taclonex® Ointment.

If irritation develops, Taclonex® Ointment should be discontinued and appropriate therapy instituted.

Allergic contact dermatitis with corticosteroids is usually diagnosed by observing failure to heal rather than by noting any clinical exacerbation as with most topical products not containing corticosteroids. Such an observation should be corroborated with appropriate diagnostic patch testing.

If concomitant skin infections are present or develop after treatment initiations, an appropriate antifungal or antibacterial agent should be used. If a favorable response does not occur promptly, use of Taclonex® Ointment should be discontinued until the infection has been adequately controlled.

Taclonex® Ointment should not be used in the presence of pre-existing skin atrophy at the treatment site.

Taclonex® Ointment should not be used on the face, axillae or groin.

Information for Patients

This information is intended to aid in the safe and effective use of this medication. It is not a disclosure of all possible adverse or intended effects.

Patients using Taclonex® Ointment should receive the following information and instructions.

1. This medication is to be used 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 hands after application.
2. This medication should not be used for any disorder other than that for which it has been prescribed.
3. The treated skin area should not be bandaged or otherwise covered or wrapped as to be occlusive, unless directed by the physician.
4. Patients should report any signs of adverse reactions to their physician.
5. Other products containing calcipotriene or a corticosteroid should not be used with Taclonex® Ointment without first talking to the physician.
6. Patients who apply Taclonex® 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 limit or avoid use of phototherapy in patients who use Taclonex® Ointment.

Laboratory Tests

See PRECAUTIONS, General.

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 ultra-violet radiation (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 who apply Taclonex® 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 limit or avoid use of phototherapy in patients that use Taclonex® Ointment.

Long-term animal studies have not been performed to evaluate the carcinogenic potential of betamethasone dipropionate.

Calcipotriene did not elicit any genotoxic effects in the Ames mutagenicity assay, the mouse lymphoma TK locus assay, the human lymphocyte chromosome aberration test, or the mouse micronucleus test.

Betamethasone dipropionate did not elicit any genotoxic effects in the Ames mutagenicity assay, the mouse lymphoma TK locus assay, or in the rat micronucleus test.

Studies in rats with oral doses of up to 54 mcg/kg/day (324 mcg/m²/day) of calcipotriene demonstrated no impairment of fertility or general reproductive performance.

Studies in rats with oral doses of up to 0.2 mg/kg/day (1,200 mcg/m²/day) of betamethasone dipropionate demonstrated no impairment of male fertility.

Pregnancy

Teratogenic Effects: Pregnancy Category C

Animal reproduction studies have not been conducted with Taclonex® Ointment. Taclonex® Ointment contains calcipotriene that has been shown to be fetotoxic and betamethasone dipropionate that has been shown to be teratogenic in animals when given systemically. There are no adequate and well-controlled studies in pregnant women. Taclonex® Ointment should be used during pregnancy only if the potential benefit to the patient justifies the potential risk to the fetus.

Teratogenicity studies with calcipotriene were performed by the oral route in rats and rabbits. In rabbits, increased maternal and fetal toxicity were noted at dosage of 12 mcg/kg/day (144 mcg/m²/day); a dosage of 36 mcg/kg/day (432 mcg/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 mcg/kg/day (324 mcg/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 levels in the rat (108 mcg/m²/day) and rabbit (48 mcg/m²/day) studies are lower than the estimated maximum topical dose in man (approximately 460 mcg/m²/day). Corticosteroids are generally teratogenic in laboratory animals when administered systemically at relatively low dosage levels. Betamethasone dipropionate has been shown to be teratogenic in mice and rabbits when given by the subcutaneous route at doses of 156 mcg/kg/day (468 mcg/m²/day) and 2.5 mcg/kg/day (30 mcg/m²/day), respectively. Those dose levels are lower than the estimated maximum topical dose in man (5,948 mcg/m²/day). The abnormalities observed included umbilical hernia, exencephaly and cleft palates.

Pregnant women were excluded from the clinical trials conducted with Taclonex® Ointment.

Nursing mothers

Safety of the use of Taclonex® Ointment during lactation has not been established.

Nursing women were excluded from the clinical trials conducted with Taclonex® Ointment.

It is not known whether topically administered calcipotriene is excreted in human milk.

It is not known whether topical administration of corticosteroids could result in sufficient systemic absorption to produce detectable quantities in breast milk.

Systemically administered corticosteroids are secreted into breast milk in quantities not likely to have a deleterious effect on the infant.

Because many drugs are excreted in human milk, caution should be exercised when Taclonex® Ointment is administered to a nursing woman.

Pediatric use

Safety and effectiveness of Taclonex® 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 subjects in clinical studies of Taclonex® Ointment, approximately 14% were 65 years and older, while approximately 3% were 75 years and over.

No overall differences in safety or effectiveness of Taclonex® Ointment were observed between these subjects and younger subjects. All other reported clinical experience has not identified any differences in response between elderly and younger patients.

Last updated on RxList: 10/17/2007

Topically applied Taclonex® Ointment can be absorbed in sufficient amounts to produce systemic effects. (See PRECAUTIONS).

Taclonex® Ointment is contraindicated in those patients with a history of hypersensitivity to any of the components of the preparation.

Taclonex® Ointment is contraindicated in patients with known or suspected disorders of calcium metabolism.

Taclonex® Ointment is contraindicated in patients with erythrodermic, exfoliative and pustular psoriasis.

Last updated on RxList: 10/17/2007

Taclonex® Ointment

Taclonex® Ointment combines the pharmacological effects of calcipotriene hydrate and betamethasone dipropionate as described below.

In a vasoconstrictor study, the skin blanching response of Taclonex® Ointment was consistent with that of a potent corticosteroid.

Calcipotriene

Pharmacokinetics: Calcipotriene metabolism following systemic uptake is rapid and occurs in the liver. The primary metabolites of calcipotriene are less potent than the parent compound.

Betamethasone dipropionate

Like other topical corticosteroids, betamethasone dipropionate has anti-inflammatory, antipruritic and vasoconstrictive properties. However, while the physiologic, pharmacologic, and clinical effects of the corticosteroids are well known, the exact mechanisms of their actions in psoriasis vulgaris are uncertain.

Pharmacokinetics: The extent of percutaneous absorption of topical corticosteroids is determined by many factors including the vehicle, the integrity of the epidermal barrier, and the use of occlusive dressings. Topical corticosteroids can be absorbed from normal intact skin. Inflammation and/or other disease processes in the skin may increase percutaneous absorption.

There are no human data regarding the distribution of corticosteroids to body organs following topical application. Nevertheless, once absorbed through the skin, topical corticosteroids are handled through pharmacokinetic pathways similar to systemically administered corticosteroids. Corticosteroids are metabolized primarily in the liver and are then excreted by the kidneys. In addition, some corticosteroids and their metabolites are also excreted in the bile.

Taclonex® Ointment was applied once daily for 4 weeks to adult patients (N = 12) with psoriasis vulgaris to study its effects on the hypothalamic-pituitary-adrenal (HPA) axis. Of eleven patients tested, none demonstrated adrenal suppression as indicated by a 30-minute post-stimulation cortisol level ≤ 18 mcg/dL.

However in another clinical study of Taclonex® Ointment, one subject (N = 19) demonstrated adrenal suppression.

Clinical Studies

In an international, multi-center, double-blind, vehicle- and active-controlled, parallel-group study, 1,603 patients with mild to very severe psoriasis vulgaris on trunk and limbs were treated once daily for 4 weeks. Patients were randomized to one of four treatment arms: Taclonex® Ointment, calcipotriene hydrate 50 mcg/g in the same vehicle, betamethasone dipropionate 0.64 mg/g in the same vehicle, and vehicle alone. The mean age of the patients was 48.4 years and 60.5% were male. Most patients had disease of moderate severity at baseline.

Efficacy was assessed as the proportion of patients with absent or very mild disease according to the Investigator's Global Assessment of Disease Severity at end of treatment (4 weeks). “Absent” disease was defined as no evidence of redness, thickness, or scaling. “Very mild disease” was defined as controlled disease, but not entirely cleared: lesions with some discoloration with absolutely minimal thickness, i.e. the edges to the lesion(s) could just be felt.

PERCENTAGE OF PATIENTS WITH ABSENT OR VERY MILD DISEASE ACCORDING TO THE INVESTIGATOR'S GLOBAL ASSESSMENT OF DISEASE SEVERITY AT END OF TREATMENT (4 WEEKS)*.

	Taclonex® Ointment N=490	Calcipotriene N=480	Betamethasone dipropionate N=476	Vehicle N=157
Absent or very mild disease	48.0%	16.5%	26.3%	7.6%
* Patients with mild disease at baseline were required to have “Absent” disease to be considered a success.

In addition to the pivotal study (N=490), four randomized, double-blind, vehicle-or active-controlled, parallel-group studies were conducted and provided supportive evidence of efficacy. These studies included a total of 1,058 patients treated with Taclonex® Ointment once daily for up to 4 weeks.

Last updated on RxList: 10/17/2007

Taclonex® Ointment
(calcipotriene, 0.005% and betamethasone dipropionate, 0.064%)

Read the Patient Information that comes with Taclonex® Ointment before you start using it and each time you use the ointment. There may be new information. This leaflet does not take the place of talking with your doctor about your condition or treatment.

What is Taclonex® Ointment and what is it used for?

Taclonex® Ointment is a prescription medicine called a topical (skin-use only). Taclonex® Ointment is used on the skin to treat psoriasis vulgaris in adults. Taclonex® Ointment contains

• calcipotriene hydrate, which is somewhat similar to vitamin D, but not the same as vitamin D, and
• betamethasone dipropionate, which is a strong (potent) corticosteroid.

It is very important that you use Taclonex® Ointment only as directed, in order to avoid serious side effects.

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 o exfoliative psoriasis
  • pustular psoriasis
• are allergic to anything in Taclonex® Ointment. See the end of this leaflet 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 if you:

• have a skin infection. Your skin infection should be treated before starting Taclonex® Ointment
• have thin-skin (atrophy) at the site to be treated. You should not use Taclonex® Ointment
• are getting phototherapy treatments 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:

• other corticosteroid medicines
• other medicines for your psoriasis

How should I use Taclonex® Ointment?

• Use Taclonex® Ointment exactly as directed by your doctor. Do not use more than the recommended weekly amount of 100 grams of Taclonex® Ointment.
• Do not use Taclonex® Ointment on your face, under your arms or on your groin. Do not get any Taclonex® Ointment in your eyes. Wash your face or eyes right away if you get Taclonex® Ointment on them.

Using Taclonex® Ointment:

• 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 push through the seal.
• Apply Taclonex® Ointment once a day to the areas of your skin affected by psoriasis. Gently rub Taclonex® Ointment into your affected skin areas.
• Do not bandage or tightly cover or wrap the treated skin area. Wear your usual clothes.
• 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.
• If you forget to use your Taclonex® Ointment, use it as soon as you remember. Then go on as before.
• Wash your hands well after using Taclonex® Ointment.

What are the possible side effects of Taclonex® Ointment?

The most common side effects are:

• itching
• rash
• skin burning

Other less common side effects with Taclonex® Ointment include:

• redness of the skin
•  inflamed hair pores (folliculitis)
• psoriasis
• skin irritation
• change of skin color (at the site of application)
• 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 if you use too much or use it for too long. Taclonex® Ointment can pass through your skin. Serious side effects may include:

• too much calcium in your blood
• 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?

• Taclonex® Ointment should be stored between 68-77°F (20-25°C); excursions permitted between 59-86°F (15-30°C). Make sure the cap on the tube is tightly closed.
• Taclonex® Ointment has an expiry date marked on the tube. Do not use the ointment after this date.
• Keep Taclonex® Ointment out of the reach of children and pets.

General information about Taclonex® Ointment

Medicines are sometimes prescribed for conditions that are not mentioned in patient information leaflets. Do not use Taclonex® Ointment for a condition for which it was not prescribed. Do not give ointment to other people, even if they have the same symptoms you have. It may harm them.

• This leaflet summarizes the most important information about Taclonex® Ointment. If you would like more information, talk with your doctor. You can ask your doctor or pharmacist for information about Taclonex® Ointment that is written for health professionals.
• Additional consumer information is available on (800) 521-8813.

What are the ingredients in Taclonex® Ointment?

Active ingredients: calcipotriene hydrate, betamethasone dipropionate

Inactive ingredients: mineral oil, PPG-15 stearyl ether, dl-alpha tocopherol, white petrolatum.

Last updated on RxList: 10/17/2007

IMPORTANT NOTE: This is a summary and does not contain all possible information about this product. For complete information about this product or your specific health needs, ask your health care professional. Always seek the advice of your health care professional if you have any questions about this product or your medical condition. This information is not intended as individual medical advice and does not substitute for the knowledge and judgment of your health care professional. This information does not contain any assurances that this product is safe, effective, or appropriate for you.

BETAMETHASONE/CALCIPOTRIENE (CALCIPOTRIOL) - TOPICAL

(bay-tah-METH-ah-sown/kal-SIP-oh-try-een)

COMMON BRAND NAME(S): Taclonex

USES: This medication is used to treat psoriasis. It helps to reduce the redness, thickening, and scaling of the skin that occurs with this condition. Healthy skin lowers your risk for infection and protects you against the environment. This product contains 2 drugs. Betamethasone is a very strong corticosteroid drug that works by decreasing swelling, redness, and itching. Calcipotriene is a form of vitamin D. It is also known as calcipotriol in other countries. It works by slowing down the growth of skin cells so that they don't build up into thickened, scaly skin patches.

This product should not be used if you have certain types of psoriasis (skin patches with pus-filled blisters, psoriasis over most of your body with intense redness/shedding/oozing). Consult your doctor for more information.

HOW TO USE: Read the Patient Information Leaflet provided by your pharmacist before you start using this product and each time you get a refill. If you have any questions, consult your doctor or pharmacist.

This medication is for use on the skin only. Apply a thin layer to the affected area(s), usually once daily or as directed by your doctor. Rub it in gently and completely. Wash your hands after using, unless you are using this medication to treat the hands. Avoid getting any medication in the eyes. If this occurs, rinse eyes immediately with water. Do not apply this product to the face, underarms, or groin area.

Do not use this medication for more than 4 weeks unless directed by your doctor. Because of the increased risk of side effects, adults should not use more than 100 grams of this product per week unless directed and closely monitored by the doctor.

Do not bandage, wrap, or cover the treated area unless your doctor instructs you to do so. Do not apply this medication to large areas of damaged skin or use it in skin folds. Do not apply more of this medication than prescribed or use it more often or for longer than directed. Doing so may increase the amount of medication that is absorbed into your bloodstream, an effect that may increase your risk of side effects.

Inform your doctor if your condition does not improve or if it worsens. It may take a week to see any improvement and 4 weeks to see the full benefit of this medication.

SIDE EFFECTS: Itching, burning, redness, or irritation of the skin 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", swelling/inflammation of the hair pores (folliculitis), worsening of psoriasis.

This product may infrequently cause an increase in the level of calcium in your blood. Tell your doctor immediately if you notice any of the following unlikely but serious side effects: unusual tiredness, mental/mood changes, unexplained constipation.

A very serious allergic reaction to this drug is unlikely, but seek immediate medical attention if it occurs. Symptoms of a serious allergic reaction may include: rash, itching, swelling, 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.

Contact your doctor for medical advice about side effects. The following numbers do not provide medical advice, but in the US you may report side effects to the Food and Drug Administration (FDA) at 1-800-FDA-1088. In Canada, you may call Health Canada at 1-866-234-2345.

PRECAUTIONS: Before using this product, tell your doctor or pharmacist if you are allergic to betamethasone or calcipotriene; or if you have any other allergies.

This medication should not be used if you have certain medical conditions. Before using this medicine, consult your doctor or pharmacist if you have: a certain mineral imbalance (high calcium blood level), thin skin in the areas to be treated.

If you have a skin infection or a skin reaction other than psoriasis (e.g., bacterial skin infection, chickenpox, herpes simplex), it should be treated before you start this medication. Betamethasone and other corticosteroid drugs can slow down your body's response to antibiotic drugs and make it more difficult to clear an infection.

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 product. Discuss this further with your doctor.

Though very unlikely, it is possible this medication will be absorbed into your bloodstream. This may have undesirable effects that may require additional corticosteroid treatment. Children and those using this drug for an extended time over most of the skin may be at higher risk, especially if they also have serious medical problems such as severe infections, injuries, or surgeries. This precaution applies for up to 1 year after stopping use of this drug. Tell your doctor immediately if any of the following side effects occur: vision problems, persistent headache, increased thirst/urination, unusual weakness, sudden weight loss, dizziness. Consult your doctor or pharmacist for more details, and tell them that you use (or have used) this medication.

Caution is advised when using this drug in children. Children may be more sensitive to the effects of large amounts of steroids. Though it is unlikely to occur with corticosteroids applied to the skin, this medication may affect growth in children if used for long periods. Monitor your child's height and rate of growth from time to time.

This medication should be used only when clearly needed during pregnancy. 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.

DRUG INTERACTIONS: Your healthcare professionals (e.g., doctor or pharmacist) may already be aware of any possible drug interactions and may be monitoring you for it. 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 corticosteroids (e.g., prednisone, hydrocortisone), other products containing calcipotriene (calcipotriol).

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 medication may be harmful if swallowed. If overdose or swallowing is suspected, contact your local poison control center or emergency room immediately. US residents can call the US national poison hotline at 1-800-222-1222. Canadian residents should call their local poison control center directly.

NOTES: Do not share this medication with others.

Laboratory and/or medical tests (e.g., blood calcium levels, adrenal gland function tests such as morning cortisol blood tests) may be performed periodically to monitor your progress or check for side effects. Consult your doctor for more details.

Try to identify and reduce the triggers that may worsen your psoriasis (e.g., stress, skin injury). Discuss with your doctor additional ways to control symptoms, such as using a moisturizer to treat dry, itching skin.

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 the US product in its tightly capped tube at room temperature between 68-77 degrees F (20-25 degrees C). Brief storage between 59-86 degrees F (15-30 degrees C) is permitted.

Store the Canadian product in the refrigerator or at room temperature between 41-77 degrees F (5-25 degrees C). However, refrigerating the product may make it more difficult to apply. If you are using this product on delicate skin, it is best to store this medication at room temperature so it is easier to rub it in.

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.

MEDICAL ALERT: Your condition can cause complications in a medical emergency. For enrollment information call MedicAlert at 1-800-854-1166 (USA) or 1-800-668-1507 (Canada).

Information last revised July 2008 Copyright(c) 2008 First DataBank, Inc.