CLIMARA Patch Ref.[10547] Active ingredients: Estradiol

Source: FDA, National Drug Code (US)  Revision Year: 2017 

Product description

Climara (estradiol transdermal system), is designed to release estradiol continuously upon application to intact skin. Six (6.5, 9.375, 12.5, 15, 18.75 and 25 cm²) systems are available to provide nominal in vivo delivery of 0.025, 0.0375, 0.05, 0.06, 0.075 or 0.1 mg respectively of estradiol per day. The period of use is 7 days. Each system has a contact surface area of either 6.5, 9.375, 12.5, 15, 18.75 or 25 cm², and contains 2, 2.85, 3.8, 4.55, 5.7 or 7.6 mg of estradiol USP respectively. The composition of the systems per unit area is identical.

Estradiol USP is a white, crystalline powder, chemically described as estra-1,3,5(10)-triene-3, 17β-diol. It has an empirical formula of C18H24O2 and molecular weight of 272.38. The structural formula is:

The Climara transdermal system comprises three layers. Proceeding from the visible surface toward the surface attached to the skin, these layers are:

  • A translucent polyethylene film.
  • An acrylate adhesive matrix containing estradiol USP.
  • A protective liner of siliconized or fluoropolymer-coated polyester film is attached to the adhesive surface and must be removed before the system can be used.

The active component of the transdermal system is estradiol. The remaining components of the transdermal system (acrylate copolymer adhesive, fatty acid esters, and polyethylene backing) are pharmacologically inactive.

Dosage Forms and Strengths
  • Climara (estradiol transdermal system), 0.025 mg per day—each 6.5 cm² system contains 2 mg of estradiol.
  • Climara (estradiol transdermal system), 0.0375 mg per day—each 9.375 cm² system contains 2.85 mg of estradiol.
  • Climara (estradiol transdermal system), 0.05 mg per day—each 12.5 cm² system contains 3.8 mg of estradiol.
  • Climara (estradiol transdermal system), 0.060 mg per day—each 15 cm² system contains 4.55 mg of estradiol.
  • Climara (estradiol transdermal system), 0.075 mg per day—each 18.75 cm² system contains 5.7 mg of estradiol.
  • Climara (estradiol transdermal system), 0.1 mg per day—each 25.0 cm² system contains 7.6 mg of estradiol.
How Supplied

Climara (estradiol transdermal system), 0.025 mg per day — each 6.5 cm² system contains 2 mg of estradiol USP
Individual Carton of 4 systems NDC 50419-454-04

Climara (estradiol transdermal system), 0.0375 mg per day — each 9.375 cm² system contains 2.85 mg of estradiol USP
Individual Carton of 4 systems NDC 50419-456-04

Climara (estradiol transdermal system), 0.05 mg per day — each 12.5 cm² system contains 3.8 mg of estradiol USP
Individual Carton of 4 systems NDC 50419-451-04

Climara (estradiol transdermal system), 0.06 mg per day — each 15 cm² system contains 4.55 mg of estradiol USP
Individual Carton of 4 systems NDC 50419-459-04

Climara (estradiol transdermal system), 0.075 mg per day — each 18.75 cm² system contains 5.7 mg of estradiol USP
Individual Carton of 4 systems NDC 50419-453-04

Climara (estradiol transdermal system), 0.1 mg per day — each 25 cm² system contains 7.6 mg of estradiol USP
Individual Carton of 4 systems NDC 50419-452-04

Drugs

Drug Countries
CLIMARA Australia, Canada, Estonia, Ireland, Italy, New Zealand, Poland, Turkey, United States, South Africa
 
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