Calcipotriene and betamethasone dipropionate

What is Calcipotriene and betamethasone dipropionate?

• Calcipotriene and betamethasone dipropionate (Taclonex) is a combination of calcipotriene, a vitamin D analog, and betamethasone dipropionate, a corticosteroid used for the treatment of plaque psoriasis.

Betamethasone dipropionate

What are the uses of this medicine?

• Calcipotriene and betamethasone dipropionate (Taclonex) topical Suspension is a prescription medicine used on the skin (topical) to treat plaque psoriasis of the scalp and body in people 12 years and older.

How does this medicine work?

• Taclonex Topical Suspension combines the pharmacological effects of calcipotriene hydrate as a synthetic vitamin D3 analog and betamethasone dipropionate as a synthetic corticosteroid.

Calcipotriene:

• Calcipotriene is a synthetic vitamin D3 analog that has a similar receptor binding affinity as natural vitamin D3.
• However, the exact mechanism of action contributing to the clinical efficacy in the treatment of psoriasis is unknown.

Betamethasone dipropionate:

• A synthetic glucocorticoid with metabolic, immunosuppressive and anti-inflammatory activities.
• Betamethasone binds to specific intracellular glucocorticoid receptors and subsequently binds to DNA to modify gene expression.
• The synthesis of certain anti-inflammatory proteins is induced while the synthesis of certain inflammatory mediators is inhibited.
• As a result, there is an overall reduction in chronic inflammation and autoimmune reactions.

Who Should Not Use this medicine ?

• This medicine have no usage limitations.

What drug interactions can this medicine cause?

• No formal drug interaction studies have been conducted with Taclonex.

Is this medicine FDA approved?

• This medication is available in ointment, gel, aerosol, or foam, formulations.
• The ointment formulation was FDA approved in 2004, and is indicated for the once daily topical treatment of plaque-type psoriasis vulgaris amenable to topical therapy.
• The foam formulation was approved by the FDA in 2015, and is indicated for the topical treatment of plaque psoriasis in patients twelve years of age and older.

How should this medicine be used?

Recommended dosage:

• Apply Taclonex Topical Suspension to affected areas on the scalp and body once daily for up to 8 weeks. Discontinue therapy when control is achieved.
• Patients age 12 to 17 years should not use more than 60 grams per week.
• Adult patients should not use more than 100 grams per week.

Administration:

• Apply Taclonex Topical Suspension to affected areas on the scalp and body 1 time a day for up to 8 weeks. You should stop treatment when your plaque psoriasis is under control, unless your healthcare provider gives you other instructions.
• If you are 12 to 17 years of age, you should not use more than 60 grams of Taclonex Topical Suspension in 1 week.
• If you are 18 years of age or older, you should not use more than 100 grams of Taclonex Topical Suspension in 1 week.
• Do not use Taclonex Topical Suspension longer than prescribed. Using too much Taclonex Topical Suspension, or using it too often, or for too long can increase your risk for having serious side effects.
• Do not apply Taclonex Topical Suspension to the scalp in the 12 hours before or after any chemical treatments to your hair. Since hair treatments may involve strong chemicals, talk with your healthcare provider first.
• Do not use Taclonex Topical Suspension in the mouth, eyes, or vagina.
• Do not use Taclonex Topical Suspension on your face, groin, or armpits, or if you have thinning of your skin (atrophy) at the treatment site.
• If you accidentally get Taclonex Topical Suspension on your face or in your eyes, wash the area with water right away.
• Wash your hands after applying Taclonex Topical Suspension.
• Do not take a bath or shower or wash your hair right after applying Taclonex Topical Suspension as the medicine will not work as well to treat your psoriasis.
• Do not bandage or cover the treated skin area, unless instructed by your healthcare provider.

What are the dosage forms and brand names of this medicine?

This medicine is available in fallowing doasage form: As Topical Suspension

This medicine is available in fallowing brand namesː

• Taclonex

What side effects can this medication cause?

The most common side effects of this medicine include:

• inflamed hair pores (folliculitis)
• skin burning

Taclonex Topical Suspension may cause serious side effects, including:

• Too much calcium in your blood or urine
• Taclonex Topical Suspension can pass through your skin
• Cushing's syndrome
• hyperglycemia
• Eye problems

What special precautions should I follow?

• Hypercalcemia and hypercalciuria have been reported. If either occurs, discontinue until parameters of calcium metabolism normalize.
• Taclonex Topical Suspension can cause reversible hypothalamic-pituitary-adrenal (HPA) axis suppression with the potential for clinical glucocorticosteroid insufficiency during and after withdrawal of treatment. Risk factors include the use of high-potency topical corticosteroid, use over a large surface area or to areas under occlusion, prolonged use, altered skin barrier, liver failure, and use in pediatric patients. Modify use should HPA axis suppression develop.
• Use of topical corticosteroids, including Taclonex® Topical Suspension, may increase the risk of posterior subcapsular cataracts and glaucoma. Taclonex Topical Suspension may cause eye irritation. Advise patients to report any visual symptoms and consider referral to an ophthalmologist for evaluation.
• Allergic contact dermatitis has been observed with use of topical calcipotriene, topical corticosteroid. Such an observation should be corroborated with appropriate diagnostic patch testing.

What to do in case of emergency/overdose?

• In case of overdose, call the poison control helpline of your country. In the United States, call 1-800-222-1222.

• Overdose related information is also available online at poisonhelp.org/help.
• In the event that the victim has collapsed, had a seizure, has trouble breathing, or can't be awakened, immediately call emergency services. In the United States, call 911.

Can this medicine be used in pregnancy?

• It is not known if Taclonex Topical Suspension will harm your unborn baby.
• Taclonex Topical Suspension may increase your chance of having a low birth weight baby.
• If you use Taclonex Topical Suspension during pregnancy, use Taclonex Topical Suspension on the smallest area of the skin and for the shortest time needed.

Can this medicine be used in children?

• It is not known if Taclonex Topical Suspension is safe and effective in children under 12 years of age.

What are the active and inactive ingredients in this medicine?

• Active ingredients: calcipotriene and betamethasone dipropionate.
• Inactive ingredients: hydrogenated castor oil, polyoxypropylene stearyl ether, all-rac-alpha-tocopherol, butylhydroxytoluene and mineral oil.

Who manufactures and distributes this medicine?

• Manufactured by: LEO Laboratories Ltd., 285 Cashel Road, Dublin 12, Ireland
• Distributed by: LEO Pharma Inc., Madison, NJ, USA

What should I know about storage and disposal of this medication?

• Store Taclonex Topical Suspension at room temperature between 68°F to 77°F (20°C to 25°C).
• Do not refrigerate Taclonex Topical Suspension.
• Keep the bottle in the carton when not in use.
• Throw away (discard) unused Taclonex Topical Suspension 6 months after it has been opened.
• Keep Taclonex Topical Suspension and all medicines out of reach of children.

• Dailymed label info on Calcipotriene and betamethasone dipropionate
• FDA Calcipotriene and betamethasone dipropionate