Dispening Contraceptives

Dosage Forms & Labelling

Overview

  • Focuses on dosage forms and labeling, particularly related to contraceptives.

Dosage Forms

  • Specific medication involved:

    • Contraceptives
    • Examples include:
    • ALESSE
      • Active ingredients: levonorgestrel and ethinyl estradiol tablets
    • LoEstrin
      • Active ingredients: similar hormonal components.
  • Manufacturer information:

    • Pfizer

Labeling Details

  • Each contraceptive has a Drug Identification Number (DIN):
    • For example, ALESSE has the DIN 00000000 (note: actual DIN was not provided in the transcript).

Oral Contraceptives Dosage Regimens

  • For 21-day regimen:

    • Take 1 tablet daily for 21 days.
    • Stop taking tablets for 7 days, then repeat the cycle.
  • For 28-day regimen:

    • Take 1 tablet daily for the entire 28 days without a pause.

Quantity Dispensed & Days Supply Guidelines

  • 21-day regimen:

    • Each cycle comprises 21 tablets followed by a 7-day off period, totaling 28 days.
    • Quantity dispensed for this regimen is 21 tablets.
  • 28-day regimen:

    • Each cycle includes 21 active tablets and 7 placebo tablets, making a total of 28 days.
    • Quantity dispensed for this regimen is 28 tablets.
  • Calculating Quantity for Multiple Packages:

    • Multiply the number of packages by 28 to determine the total days supply.

    • Example 1:

      • For 3 packages of ALESSE 21:
      • Calculation:
        3 imes 28 = 84 days
    • Example 2:

      • For 2 packages of LoEstrin 28:
      • Calculation:
        2 imes 28 = 56 days
    • Example 3:

      • Quantity to dispense for 3 packages of Alysena 21:
      • Total Tablets:
        • 21 tablets/package x 3 packages = 63 tablets.
    • Evaluate days supply:

      • Days supply for 3 packages is calculated as:
        3 imes 28 = 84 days.

Oral Contraceptive Labeling

  • Requirement: For multiple packages, provide one label for each package clearly indicating the regimen.

  • Protocol for dispensing:

    • Split labels among multiple packages.
  • Specific example for handling labels:

    • For 3 packages of the 21-day regimen, prepare 3 labels, each stating 21 tablets.
  • Example Format: Ensure to format and place labels appropriately to reflect the cycle clearly, intending to avoid confusion regarding dosage and usage.