Prescribing information (package insert) - Tramapap
- 1. RX Only
For Prescription Compounding Only
Tramapap Kit
Tramadol HCl and Acetaminophen Compound Kit
Description
Each Tramapap Kit is comprised of 15 grams of tramadol hydrochloride powder and 75 grams of acetaminophen powder.
Certificate of Analysis on File
Tramapap Kit also contains 23.25 grams of Lactose Monohydrate (Spray dried) powder and 1.5 grams of
riboflavin USP powder. When compounded, the final product provides a homogeneous product of 300
capsules each capsule containing 50mg of tramadol and 250mg of acetaminophen.
Equipment
Required supplies needed to compound this kit
Equipment
| Item | Quantity |
|---|---|
| Tramadol HCl (Included) | 15 grams |
| Acetaminophen (Included) | 75 grams |
| Lactose Monohydrate Spray Dried Powder ( Included) | 23.25 grams |
| Riboflavin Powder (Included) | 1.5 grams |
| Red/Blue #1 Capsules ( Required Not Included) | 300 Capsules |
Equipment
Recommended supplies not included in this kit
Equipment
| Item | Quantity |
|---|---|
| 16 oz Glass Mortar and Pestle | 1 each |
| 300 Capsule Machine Number 2 Notch | 1 |
| Scraper ( Recommended Not Included) | 1 |
| Tamper (Recommended Not Included) | 1 |
| Capsule Locker (Recommended Not Included) | 1 |
Directions
- 1. Using a 16 oz mortar and pestle triturate powders well to reduce particle size until uniform.
- 2. Using a 300 capsule machine encapsulate triturate powder mixture into number 1 red/blue capsules
Prior to compounding, store Tramapap Kit at room temperature. Store the final product at room temperature.
Final product for oral use only. Keep out the reach of children. Compounded product, as dispensed,
is stable for at least 180 days or the time remaining on the expiration date of any given ingredient,
which ever is shorter.