Dispensing Rectal and Vaginal Dosage Forms

Dosage Forms & Labelling

General Overview

  • This document covers various dosage forms and their proper labelling practices.

Dosage Forms

  • Rectal Dosage Forms:
    • Suppositories:
    • Description: Small solid dosage forms designed for insertion into the rectum.
    • Administration Instructions: Unwrap and insert one suppository rectally.
    • Ointments/Creams:
    • Description: Semi-solid formulations that may be administered through rectal route or applied externally.
    • Administration Instructions:
      • Apply rectally.
      • Using the applicator, insert rectally.

Labelling Practices

  • General Labelling Rules:
    • For products with multiple packages, split labels accordingly.
    • Suppositories: Intended for internal use only; do not use an external use label.
    • Creams/Ointments: May be applied internally, so external use label usually not applied.
Calculating Days Supply
  • For suppositories, calculate days supply as follows:
    • Formula: Total number of suppositories in a package divided by the number of times they are taken per day.
    • Example: A package containing 12 suppositories used twice a day would last 6 days.
  • For creams/ointments, make a reasonable estimate based on their usage:
    • Example: Assess daily application to determine how long the product will last.

Vaginal Dosage Forms

  • Creams:
    • Administration: Insert one applicator full vaginally. Note: Sometimes the cream can also be applied externally, particularly in combination packs.
  • Ovules/Tablets:
    • Administration: Unwrap and insert using the applicator, placing 1 ovule vaginally.
Labelling for Vaginal Products
  • Split labels for multiple packaging.
  • Calculating Days Supply:
    • For suppositories: Total number of suppositories divided by the number used per day.
    • Example: 12 suppositories/1 at bedtime = 12 days supply.
    • For creams/ointments: Often indicated by the product label the duration of treatment (e.g., treatments lasting 1 day, 3 days, or 7 days).
    • Calculation: If the applicator holds known grams of cream, you can determine the duration:
    • Example: A 14 g cream applied daily using a 1 g applicator would last 14 days.

Enema

  • Administration Instructions:
    • Remove cap and insert the tip into the rectum. Squeeze the bottle to empty its contents.
  • Use Duration:
    • Enemas may be a one-time use (1-day supply) or can be used over multiple days.
    • Each bottle typically represents one dose; thus, calculate days supply based on the directions.
    • Example: If using 1 enema at bedtime for a box of 14 enemas, it would last 14 days.