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.
- Days supply for 3 packages is calculated as:
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.