TACLONEX .5 mg/g
calcipotriene and betamethasone dipropionate · SUSPENSION · LEO Pharma Inc.
TACLONEX is a suspension containing calcipotriene and betamethasone dipropionate at .5 mg/g, taken topical. Manufactured by LEO Pharma Inc..
Key Facts
- Brand Name
- TACLONEX
- Generic Name
- calcipotriene and betamethasone dipropionate
- NDC Code (Product)
50222-501- Manufacturer
- LEO Pharma Inc.
- Strength
- .5 mg/g
- Dosage Form
- SUSPENSION
- Route
- TOPICAL
- Marketing Status
- Application #
- NDA022185
- Marketing Start
- 06/01/2008
Recall History
LEO PHARMA INC
Labeling: Incorrect or missing package insert: the affected product was packaged with an out-of-date package insert (PI) dated February 2014.
Side Effects Reported to FDA
FDA FAERS database · These are reported events, not confirmed side effects
Full Prescribing Information
Indications & Usage
1 INDICATIONS AND USAGE Taclonex ® Topical Suspension is indicated for the topical treatment of plaque psoriasis of the scalp and body in patients 12 years and older. Taclonex Topical Suspension is a combination of calcipotriene, a vitamin D analog, and betamethasone dipropionate, a corticosteroid, indicated for the topical treatment of plaque psoriasis of the scalp and body in patients 12 years and older. ( 1 )
Dosage & Administration
2 DOSAGE AND ADMINISTRATION Instruct patients to shake bottle prior to using Taclonex Topical Suspension. Apply Taclonex Topical Suspension to affected areas on the scalp and body once daily for up to 8 weeks. Taclonex Topical Suspension should be discontinued when control is achieved. Instruct patients to wash their hands after applying the product. Inform patients that they should not take a bath or shower or wash their hair right after application of Taclonex Topical Suspension. Patients 12 to 17 years should not use more than 60 grams per week and patients 18 years and older should not use more than 100 grams per week. Taclonex Topical Suspension should not be: Used with occlusive dressings unless directed by a healthcare provider. Used on the face, groin, or axillae, or if skin atrophy is present at the treatment site. Applied to the scalp in the 12 hours before or after any chemical treatments to the hair. Taclonex Topical Suspension is not for oral, ophthalmic, or intravaginal use. Shake bottle before use. ( 2 ) 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. ( 2 ) Patients …
Contraindications
4 CONTRAINDICATIONS None. None. ( 4 )
Adverse Reactions
6 ADVERSE REACTIONS The most common adverse reactions (≥ 1%) are folliculitis and burning sensation of skin. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact LEO Pharma Inc. at 1-877-494-4536 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience 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. Clinical Trials Conducted in Subjects 18 years and older with Psoriasis of the Scalp The rates of adverse reactions described below were from randomized, multicenter, vehicle- and/or active controlled clinical trials in adult subjects with psoriasis of the scalp [see Clinical Studies (14) ]. Subjects applied study product once daily for 8 weeks, and the median weekly dose was 12.6 grams. Adverse reactions that occurred in ≥ 1% of subjects treated with Taclonex Topical Suspension and at a rate higher than in subjects treated with vehicle are presented in Table 1. Table 1. Number and Percentage of Subjects with Adverse Reactions in Scalp Psoriasis Tri…
Frequently Asked Questions
What is TACLONEX used for?
TACLONEX contains calcipotriene and betamethasone dipropionate. It is a suspension taken topical. Consult your doctor for specific uses.
Is TACLONEX a controlled substance?
TACLONEX is not classified as a controlled substance by the DEA.
What is the generic name for TACLONEX?
The generic name for TACLONEX is calcipotriene and betamethasone dipropionate. There are 5 other brand versions of calcipotriene and betamethasone dipropionate.
What is the NDC code for TACLONEX .5 mg/g?
The NDC (National Drug Code) for TACLONEX .5 mg/g is 50222-501, listed by LEO Pharma Inc..