TACLONEX SCALP®
(calcipotriene 0.005% and betamethasone dipropionate 0.064%) Topical Suspension
Taclonex Scalp® Topical Suspension contains calcipotriene hydrate and betamethasone dipropionate. It is intended for topical use on the scalp.
Calcipotriene hydrate is a synthetic vitamin D3 analogue.
Chemically, calcipotriene hydrate is 9,10-Secochola-5,7,10(19),22- tetraene-1,3,24- triol,24-cyclo-propyl-, monohydrate, (1α,3β,5Z,7E,22E,24S) with the empirical formula C27H40O3,H2O, a molecular weight of 430.6, and the following structural formula:
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Calcipotriene hydrate is a white to almost white, crystalline compound.
Betamethasone dipropionate is a synthetic corticosteroid.
Betamethasone dipropionate has the chemical name Pregna-1,4- diene-3,20-dione-9- fluoro-11-hydroxy-16-methyl-17,21-bis(1-oxypropoxy)-(11β,16β), with the empirical formula C28H37FO7, a molecular weight of 504.6, and the following structural formula:
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Betamethasone dipropionate is a white to almost white, crystalline powder.
Each gram of Taclonex Scalp® Topical Suspension 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 a base of hydrogenated castor oil, PPG-15 stearyl ether and mineral oil.
Last updated on RxList: 6/18/2008
Taclonex Scalp® Topical Suspension is indicated for the topical treatment of moderate to severe psoriasis vulgaris of the scalp in adults 18 years and older.
Apply Taclonex Scalp® Topical Suspension to affected areas on the scalp once daily for 2 weeks or until cleared. Treatment may be continued for up to 8 weeks. The maximum weekly dose should not exceed 100 g. Patients should shake the bottle prior to using the product. Patients should wash their hands after applying Taclonex Scalp® Topical Suspension.
Taclonex Scalp® Topical Suspension is not for oral, ophthalmic, or intravaginal use.
Each gram of Taclonex Scalp® Topical Suspension 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).
Taclonex Scalp® Topical Suspension is available in bottles of:
15 g (NDC 0430-3240-11)
30 g (NDC 0430-3240-13)
60 g (NDC 0430-3240-15)
2 x 60 g (NDC 0430-3240-17)
Store between 20-25°C (68-77°F); excursions permitted between 15-30°C (59-86°F). Do not refrigerate. Keep the bottle in the outer carton when not in use. The product should be used within three months after it has been opened.
Keep out of reach of children.
Shake before use.
Manufactured by: LEO Pharmaceutical Products Ltd. A/S, Industriparken 55, DK- 2750 Ballerup, Denmark. Marketed by: Warner Chilcott (US), LLC, Rockaway, NJ 07866, USA. 1-800-521-8813. Issued May 2008. FDA rev date: 5/9/2008
Last updated on RxList: 6/18/2008
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 rates of adverse reactions given below were derived from randomized, multicenter, prospective vehicle- and/or active-controlled clinical studies in subjects with scalp psoriasis. Subjects applied study product once daily for 8 weeks, and the median weekly dose was 12.6 g.
Adverse reactions that occurred in ≥ 1% of subjects treated with Taclonex Scalp® Topical Suspension and at a rate higher than in subjects treated with vehicle are presented in Table 1:
Table 1
| Number and Percentage of Patients with Adverse Reactions in Scalp Psoriasis Studies (Events Reported by ≥ 1% of Subjects and for Which a Relationship is Possible)* | ||||
| Taclonex Scalp® Topical Suspension N=1,953 |
Betamethasone dipropionate in vehicle N=1,214 |
Calcipotriene in vehicle N=979 |
Vehicle N=173 |
|
| Event | # of subjects (%) | |||
| Folliculitis | 16 (1%) | 12 (1%) | 5 (1%) | 0 (0%) |
| Burning sensation of skin | 13 (1%) | 10 (1%) | 29 (3%) | 0 (0.0%) |
| * Adverse reactions reported at a rate higher than vehicle. | ||||
Other less common reactions (less than 1% but more than 0.1%) were, in decreasing order of incidence: acne, exacerbation of psoriasis, eye irritation, and pustular rash.
In a 52-week study, adverse reactions that were reported by greater than 1% of subjects treated with Taclonex Scalp® Topical Suspension were pruritus (3.6%), psoriasis (2.4%), erythema (2.1%), skin irritation (1.4%), and folliculitis (1.2%). The effects of Taclonex Scalp® Topical Suspension on calcium metabolism and the HPA axis were not investigated in the 52-week study.
Hypercalcemia and hypercalciuria have been observed with use of Taclonex Scalp® Topical Suspension. If hypercalcemia or hypercalciuria develop, treatment should be discontinued until parameters of calcium metabolism have normalized. The effects of Taclonex Scalp® Topical Suspension on calcium metabolism following treatment durations of more than 8 weeks have not been evaluated.
Systemic absorption of topical corticosteroids can produce reversible hypothalamic- pituitary-adrenal (HPA) axis suppression with the potential for clinical glucocorticosteroid insufficiency. This may occur during treatment or upon withdrawal of the topical corticosteroid.
In a study of 32 subjects treated with Taclonex Scalp® Topical Suspension on the scalp and Taclonex® Ointment on the body, adrenal suppression was identified in 5 of 32 subjects (15.6%) after 4 weeks of treatment and in 2 of 11 subjects (18.2%) who continued treatment for 8 weeks. [See CLINICAL PHARMACOLOGY, Pharmacodynamics]
Because of the potential for systemic absorption, use of topical corticosteroids may require that patients be periodically evaluated for HPA axis suppression. Factors that predispose a patient using a topical corticosteroid to HPA axis suppression include the use of more potent steroids, use over large surface areas, use over prolonged periods, use under occlusion, use on an altered skin barrier, and use in patients with liver failure.
An ACTH stimulation test may be helpful in evaluating patients for HPA axis suppression. If HPA axis suppression is documented, an attempt should be made to gradually withdraw the drug, to reduce the frequency of application, or to substitute a less potent steroid. Manifestations of adrenal insufficiency may require supplemental systemic corticosteroids. Recovery of HPA axis function is generally prompt and complete upon discontinuation of topical corticosteroids.
Cushing's syndrome, hyperglycemia, and unmasking of latent diabetes mellitus can also result from systemic absorption of topical corticosteroids.
Use of more than one corticosteroid-containing product at the same time may increase the total systemic corticosteroid exposure.
Pediatric patients may be more susceptible to systemic toxicity from use of topical corticosteroids. [See Use in Specific Populations]
Local adverse reactions may be more likely to occur with occlusive use, prolonged use or use of higher potency corticosteroids. Reactions may include atrophy, striae, telangiectasias, burning, itching, irritation, dryness, folliculitis, acneiform eruptions, hypopigmentation, perioral dermatitis, allergic contact dermatitis, secondary infection, and miliaria. Some local adverse reactions may be irreversible.
Allergic contact dermatitis to any component of topical corticosteroids is usually diagnosed by a failure to heal rather than a clinical exacerbation. Clinical diagnosis of allergic contact dermatitis can be confirmed by patch testing.
Allergic contact dermatitis has been observed with use of topical calcipotriene. Clinical diagnosis of allergic contact dermatitis can be confirmed by patch testing.
Concomitant skin infections should be treated with an appropriate antimicrobial agent. If the infection persists, Taclonex Scalp® Topical Suspension should be discontinued until the infection has been adequately treated.
The safety and efficacy of Taclonex Scalp® Topical Suspension in patients with known or suspected disorders of calcium metabolism have not been evaluated.
The safety and efficacy of Taclonex Scalp® Topical Suspension in patients with erythrodermic, exfoliative or pustular psoriasis have not been evaluated.
The safety and efficacy of Taclonex Scalp® Topical Suspension in patients with severe renal insufficiency or severe hepatic disorders have not been evaluated.
Avoid eye exposures. Taclonex Scalp® Topical Suspension may cause eye irritation.
Patients who apply Taclonex Scalp® Topical Suspension to exposed skin (e.g. a bald scalp) 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 to the scalp in patients who use Taclonex Scalp® Topical Suspension.
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 Scalp® Topical Suspension should receive the following information and instructions.
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. This medication should not be used for any disorder other than that for which it has been prescribed. The treated skin area should not be bandaged or otherwise covered as to be occlusive, unless directed by the physician.
Patients should report any signs of adverse reactions to their physician.
Other products containing calcipotriene or a corticosteroid should not be used with Taclonex Scalp® Topical Suspension without first talking to the physician.
Patients who use Taclonex Scalp® Topical Suspension 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 Scalp® Topical Suspension.
When calcipotriene was applied topically for up to 24 months at dosages of 3, 10 and 30 mcg/kg/day (corresponding to 9, 30 and 90 mcg/m2/day), no biologically 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.
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 effect in the Ames mutagenicity assay, the mouse lymphoma TK locus assay, or in the rat micronucleus test.
Studies in rats at doses of up to 54 mcg/kg/day (324 mcg/m2/day) of calcipotriene indicated no impairment of fertility or general reproductive performance.
Studies in male rats at oral doses of up to 200 mcg/kg/day (1,200 mcg/m2/day), and in female rats at oral doses of up to 1,000 mcg/kg/day (6,000 mcg/m2/day) of betamethasone dipropionate indicated no impairment of fertility.
Animal reproduction studies have not been conducted with Taclonex Scalp® Topical Suspension. Taclonex Scalp® Topical Suspension 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 Scalp® Topical Suspension 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 a 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 were most likely due to the effect of calcipotriene upon calcium metabolism. The estimated maternal and fetal no- adverse effect levels (NOAEL) in the rat (108 mcg/m2/day) and rabbit (48 mcg/m2/day) derived from oral studies are lower than the maximum topical dose of calcipotriene in man (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 (468 mcg/m2/day) and 2.5 mcg/kg (30 mcg/m2/day), respectively. Those dose levels are lower than the maximum topical dose in man (about 5,950 mcg/m2/day). The abnormalities observed included umbilical hernia, exencephaly and cleft palate.
Pregnant women were excluded from the clinical studies conducted with Taclonex Scalp® Topical Suspension.
Systemically administered corticosteroids appear in human milk and could suppress growth, interfere with endogenous corticosteroid production, or cause other untoward effects.
It is not known whether topically administered calcipotriene or corticosteroids could result in sufficient systemic absorption to produce detectable quantities in human milk.
Because many drugs are excreted in human milk, caution should be exercised when Taclonex Scalp® Topical Suspension is administered to a nursing woman.
Safety and effectiveness of the use of Taclonex Scalp® Topical Suspension in pediatric patients have not been studied. Because of a higher ratio of skin surface area to body mass, children under the age of 12 years may be at particular risk of systemic adverse effects when they are treated with topical corticosteroids. [See WARNINGS AND PRECAUTIONS]
HPA axis suppression, Cushing's syndrome, linear growth retardation, delayed weight gain, and intracranial hypertension have been reported in children receiving topical corticosteroids. Manifestations of adrenal suppression in children include low plasma cortisol levels and absence of response to ACTH stimulation. Manifestations of intracranial hypertension include bulging fontanelles, headaches, and bilateral papilledema.
Of the total number of patients in the controlled clinical studies of Taclonex Scalp® Topical Suspension, 334 were 65 years or older, while 84 were 75 years or older.
No overall differences in safety or effectiveness of Taclonex Scalp® Topical Suspension were observed between these patients and younger patients. All other reported clinical experience has not identified any differences in response between elderly and younger patients.
Last updated on RxList: 6/18/2008
Taclonex Scalp® Topical Suspension can be absorbed in sufficient amounts to produce systemic effects [See WARNINGS AND PRECAUTIONS].
Taclonex Scalp® Topical Suspension combines the pharmacological effects of calcipotriene hydrate as a synthetic vitamin D3 analogue and betamethasone dipropionate as a synthetic corticosteroid. However, while their pharmacologic and clinical effects are known, the exact mechanisms of their actions in psoriasis vulgaris are unknown.
Hypothalamic-Pituitary-Adrenal (HPA) Axis Suppression:
HPA axis suppression was evaluated in adult subjects (N=32) with extensive psoriasis involving at least 30% of the scalp and, in total, 15-30% of the body surface area.
Treatment consisted of once daily application of Taclonex Scalp® Topical Suspension on the scalp in combination with Taclonex® Ointment on the body for 4 to 8 weeks. Adrenal suppression as indicated by a 30-minute post-stimulation cortisol level ≤ 18 mcg/dL was observed in 5 of 32 subjects (15.6%) after 4 weeks of treatment and in 2 of 11 subjects (18.2%) who continued treatment for 8 weeks.
Effects on Calcium Metabolism:
In the study described above, the effects of once daily application of Taclonex Scalp® Topical Suspension on the scalp in combination with Taclonex® Ointment on the body for 4 to 8 weeks on calcium metabolism were also examined. Following once daily application of Taclonex Scalp® Topical Suspension on the scalp in combination with Taclonex® Ointment on the body, elevated urinary calcium levels outside the normal range were observed in two subjects (one at 4 weeks and one at 8 weeks).
Taclonex Scalp® Topical Suspension:
The systemic effect of Taclonex Scalp® Topical Suspension in extensive psoriasis was investigated in the study described above. In this study, the serum levels of calcipotriene and betamethasone dipropionate and their major metabolites were measured after 4 and 8 weeks of once daily application of Taclonex Scalp® Topical Suspension on the scalp in combination with Taclonex® Ointment on the body. Calcipotriene and betamethasone dipropionate were below the lower limit of quantification in all serum samples of the 34 subjects evaluated.
However, one major metabolite of calcipotriene (MC1080) was quantifiable in 10 of 34 (29.4%) subjects at week 4 and in five of 12 (41.7%) subjects at week 8. The major metabolite of betamethasone dipropionate, betamethasone 17-propionate (B17P) was also quantifiable in 19 of 34 (55.9%) subjects at week 4 and seven of 12 (58.3%) subjects at week 8. The serum concentrations for MC1080 ranged from 20-75 pg/mL. The clinical significance of this finding is unknown.
Calcipotriene:
Calcipotriene metabolism following systemic uptake is rapid and occurs in the liver. The primary metabolites of calcipotriene are less potent than the parent compound.
Calcipotriene is metabolized to MC1046 (the α,ß-unsaturated ketone analog of calcipotriene), which is metabolized further to MC1080 (a saturated ketone analog). MC1080 is the major metabolite in plasma. MC1080 is slowly metabolized to calcitroic acid.
Betamethasone dipropionate:
Betamethasone dipropionate is metabolized to betamethasone 17-propionate and betamethasone, including the 6ß-hydroxy derivatives of those compounds by hydrolysis. Betamethasone 17-propionate (B17P) is the primary metabolite.
Two multicenter, randomized, double-blind studies were conducted. In Study One, 1,407 subjects were randomized to one of four treatment groups: Taclonex Scalp® Topical Suspension, betamethasone dipropionate in the same vehicle, calcipotriene hydrate in the same vehicle, or the vehicle alone. Study Two did not include a vehicle arm; 1,280 subjects were randomized to one of three treatment groups: Taclonex Scalp® Topical Suspension, betamethasone dipropionate in the same vehicle, or calcipotriene hydrate in the same vehicle. Both studies enrolled subjects with moderate to very severe scalp psoriasis. The majority of subjects had disease of moderate severity at baseline. Subjects were treated once daily for 8 weeks.
Efficacy was assessed as the proportion of patients at Week 8 with absent or very mild disease according to an Investigator's Global Assessment of Disease Severity. "Clear" was defined as no evidence of redness, thickness or scaling. "Almost clear" was defined as an overall clinical picture of lesions with the presence of minimal erythema. Table 2 contains the response rates in each of these two trials.
Table 2
| Percentage of Patients with Clear or Almost Clear Disease According to the Investigator's Global Assessment of Disease Severity | ||||
| Taclonex Scalp® Topical Suspension | Betamethasone dipropionate in vehicle | Calcipotriene in vehicle | Vehicle | |
| Study One | (N = 494) | (N = 531) | (N = 256) | (N = 126) |
| Week 2 | 55.5% | 46.1% | 18.4% | 9.5% |
| Week 8 | 70.0% | 63.1% | 36.7% | 19.8% |
| Study Two | (N = 512) | (N = 517) | (N = 251) | - |
| Week 2 | 47.1% | 36.4% | 12.7% | - |
| Week 8 | 67.2% | 59.6% | 41.0% | - |
Last updated on RxList: 6/18/2008
Taclonex Scalp®
(pronounced TAK-lo-NEKS skalp)
(calcipotriene, 0.005% and betamethasone dipropionate, 0.064%) Topical Suspension
Read the Patient Information that comes with Taclonex Scalp® Topical Suspension before you start using it and each time you refill your prescription. There may be new information. This leaflet does not take the place of talking with your doctor about your condition or treatment.
Important information: Taclonex Scalp® Topical Suspension is for use on the scalp only (topical use only). Do not use Taclonex Scalp® Topical Suspension on the face, under arms or on groin area. Do not swallow Taclonex Scalp® Topical Suspension. Another product, Taclonex® Ointment contains the same medicine that is in Taclonex Scalp® Topical Suspension and is used to treat psoriasis vulgaris of the skin. 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.
What is Taclonex Scalp® Topical Suspension?
Taclonex Scalp® Topical Suspension is a prescription medicine that is for use on the scalp only (a topical medicine). Taclonex Scalp® Topical Suspension is used to treat psoriasis vulgaris in adults 18 years of age and older. Taclonex Scalp® Topical Suspension is not recommended for use in children. Taclonex Scalp® Topical Suspension has not been studied in patients under the age of 18.
Who should not use Taclonex Scalp® Topical Suspension?
Do not use Taclonex Scalp® Topical Suspension if you:
What should I tell my doctor before using Taclonex Scalp® Topical Suspension?
Tell your doctor about all of your health conditions, including if you:
Tell your doctor about all the medicines you take, including prescription, and nonprescription medicines, vitamins and herbal supplements.
Taclonex Scalp® Topical Suspension and some other medicines may interact with each other. Especially tell your doctor if you use:
How should I use Taclonex Scalp® Topical Suspension?
Using Taclonex Scalp® Topical Suspension:
Remove the cap and apply Taclonex Scalp® Topical Suspension one time each day to the areas of your scalp affected by psoriasis, using the following steps (See the figures below).
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Washing your hair before application of Taclonex Scalp® Topical Suspension is not necessary.
What should I avoid while using Taclonex Scalp® Topical Suspension?
Avoid spending a long time in sunlight. Avoid tanning booths and sun lamps. Use sunscreen and wear a hat if you have to be in sunlight. Talk to your doctor if you get a sunburn.
What are the possible side effects of Taclonex Scalp® Topical Suspension?
Taclonex Scalp® Topical Suspension may cause serious side effects. Serious side effects are more likely to happen if you use too much Taclonex Scalp® Topical Suspension, use it for too long, or use it with other topical medicines that contain corticosteroids, calcipotriene, or certain other ingredients. Check with your health care professional before using other topical medicines. Taclonex Scalp® Topical Suspension can pass through your skin and be absorbed into the body.
Serious side effects may include:
Your doctor may do special blood and urine tests to check your calcium levels and adrenal gland function while you are using Taclonex Scalp® Topical Suspension. Other side effects include:
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 Scalp® Topical Suspension. Ask your doctor or pharmacist for more information.
How should I store Taclonex Scalp® Topical Suspension?
General information about Taclonex Scalp® Topical Suspension. Medicines are sometimes prescribed for conditions that are not mentioned in patient information leaflets. Do not use Taclonex Scalp® Topical Suspension for a condition for which it was not prescribed. Do not give your Taclonex Scalp® Topical Suspension 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 Scalp® Topical Suspension. If you would like more information, talk with your doctor. You can ask your doctor or pharmacist for information about Taclonex Scalp® Topical Suspension that is written for health professionals. For more information, please visit www.warnerchilcott.com or call 1-800-521-8813.
What are the ingredients in Taclonex Scalp® Topical Suspension?
Active ingredients: calcipotriene hydrate, betamethasone dipropionate.
Inactive ingredients: hydrogenated castor oil, PPG-15 stearyl ether and mineral oil.
Last updated on RxList: 6/18/2008
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) SCALP - TOPICAL
(bay-tah-METH-ah-sown/kal-si-POE-try-ole)
COMMON BRAND NAME(S): Taclonex Scalp
USES: This product contains 2 drugs (betamethasone and calcipotriene) and is used to treat psoriasis of the scalp. Betamethasone is a very strong corticosteroid drug that helps decrease the swelling, redness, and itching of the skin that occurs with this condition. Calcipotriene, which is also known as calcipotriol in other countries, is a form of vitamin D. It works by slowing down the growth of skin cells so that they do not build up into thickened, scaly skin patches.
This medication should not be used if you have certain types of psoriasis (skin patches with pus-filled blisters, psoriasis with intense redness/shedding/oozing). Consult your doctor for more information.
This product is not recommended for use in children because they may be at an increased risk for side effects. See also Side Effects and Precautions sections.
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 scalp only. Do not apply this product 12 hours before or after any chemical treatments to your hair. Shake the bottle well before use. Part your hair, apply the product only to the affected area(s) of the scalp, and gently rub in, usually once daily or as directed by your doctor. Wash your hands after using, but do not wash your hair right after applying this product. Avoid getting any medication in the eyes or ears. If this occurs, immediately rinse with plenty of water. Do not apply this product to the face, underarms, or groin area.
Do not use this medication for more than 8 weeks unless directed by your doctor. Because of the increased risk of side effects, do not use more than 100 grams of this product a week unless directed and closely monitored by your doctor.
Do not bandage, wrap, or cover the treated area unless your doctor instructs you to do so. Do not use this medication 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.
Tell your doctor if your condition does not improve or if it worsens. It may take up to 2 weeks to see any improvement.
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 medication may infrequently cause an increase in the level of calcium in your blood or urine. Tell your doctor immediately if you notice any of the following unlikely but serious side effects: unusual tiredness, mental/mood changes, unexplained constipation, pink/bloody urine, painful urination.
Rarely, it is possible this medication will be absorbed from the skin into the bloodstream. This can lead to side effects from too much corticosteroid medication. These side effects are more likely in children and people who use this medication for a long time or over large areas of skin. Tell your doctor immediately if any of the following side effects occur: weight loss, headache, vision problems, increased thirst/urination, swelling ankles/feet.
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.
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 medication, tell your doctor or pharmacist if you are allergic to betamethasone or calcipotriene; or if you have any other allergies.
Before using this medication, tell your doctor your medical history, especially of: a certain mineral imbalance (high calcium levels in the blood or urine), thin skin in the area to be treated, liver disease.
If you have a skin infection or a skin reaction other than psoriasis (such as 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.
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.
Rarely, using corticosteroid medications for a long time can make it more difficult for your body to respond to physical stress. Therefore, before having surgery or emergency treatment, tell your doctor or dentist that you are using this medication or have used this medication within the past few months. Also tell your doctor about your use of this medication if you get a serious infection or injury.
Children may be more sensitive to the effects of too much corticosteroid medication. Though it is unlikely to occur with corticosteroids applied to the skin, this medication may temporarily slow down a child's rate of growth if used for long periods. However, it will probably not affect final adult height. Monitor your child's height periodically.
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 when applied to the skin. Consult your doctor before breast-feeding.
Before using this medication, tell your doctor or pharmacist of all prescription and nonprescription/herbal products you may use, especially of:
Before using this medication, tell your doctor or pharmacist of all prescription and nonprescription/herbal products you may use, especially of: other corticosteroid drugs (such as hydrocortisone, prednisone), other products containing calcipotriene.
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 or 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. Canada residents can call a provincial poison control center.
NOTES: Do not share this medication with others.
Laboratory and/or medical tests (such as calcium levels, adrenal gland function tests) may be performed periodically to check for side effects. Consult your doctor for more details.
Try to identify and reduce the triggers that may worsen your psoriasis (such as stress, skin injury, smoking). Discuss with your doctor additional ways to control symptoms.
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 between 68-77 degrees F (20-25 degrees C). Brief storage between 59-86 degrees F (15-30 degrees C) is permitted.
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 July 2008 Copyright(c) 2008 First DataBank, Inc.
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