FDA licensing field trials have proven PRASCEND safety
To obtain FDA approval, rigorous licensing and safety studies demonstrated the safety profile of PRASCEND at up to 2 times the maximum dose.1-3 A 6-month, margin of safety field study proved that PRASCEND is safe to use in horses to control common clinical signs of PPID.2,3 In this study, PRASCEND tablets were given once daily at up to 2 times the normal maximum dosage. Thirty-two Paint and Appaloosa horses ranging from 3 to 10 years of age were studied. Investigators concluded that PRASCEND is safe for use when administered orally to horses at a dose of up to 4 mcg/kg once daily.3
Large field efficacy trial confirms PRASCEND safety
For added confidence in prescribing PRASCEND, additional safety monitoring of adverse events was conducted throughout the large-scale, multi-site efficacy field trial.
A total of 122 horses were included in the field study safety analysis. Study horses included both males and females representing 16 different breeds. Horses were either privately or university-owned and located at sites across the US.
Adverse events associated with PRASCEND included decreased appetite, weight loss, lethargy, and behavioral changes. Most of the reactions were either transient or resolved with a temporary dose adjustment.
Field trial results confirmed that PRASCEND was well tolerated, caused mild adverse reactions, and is safe for use to treat clinical signs of PPID in horses and ponies.
| Clinical signs | # Cases | Cases (%) |
|---|---|---|
| Decreased appetite | 40 | 32.8 |
| Lameness | 22 | 18 |
| Diarrehea/loose stool | 12 | 9.8 |
| Colic | 12 | 9.8 |
| Lethargy | 12 | 9.8 |
| Abnormal weight loss | 11 | 9.0 |
| Laminitis* | 10 | 8.2 |
| Heart murmur | 10 | 8.2 |
| Death | 8 | 6.6 |
| Tooth disorder | 8 | 6.6 |
| Skin abscess | 7 | 5.7 |
| Musculoskeletal pain | 6 | 4.9 |
| Behavior change | 6 | 4.9 |
| *Three new cases and 7 pre-existing, recurring cases | ||
PRASCEND administration
PRASCEND tablets and packaging were designed to make administration easy for owners and horses. The tablets dissolve easily in water and may be mixed with food, hidden inside an apple, or a treat. Tablets should not be crushed, as to minimize the potential for human exposure. Pregnant or lactating women to wear gloves when handling.
After the tablet dissolves, owners can either squirt the liquid into the horse’s mouth with a syringe or apply as a top-dressing on feed. Or, they can hide an undissolved tablet in an apple or other treat for their horse. When the tablet is dissolved, PRASCEND should be used immediately.
Important Safety Information for Humans
Not for use in humans. Keep this and all medications out of the reach of children. PRASCEND should not be administered by persons who have had adverse reactions to ergotamine or other ergot derivatives. Pregnant or lactating women should wear gloves when administering this product. It has been reported that pergolide tablets may cause eye irritation, an irritating smell, or headache when PRASCEND Tablets are split or crushed. PRASCEND Tablets should not be crushed due to the potential for increased human exposure and care should be taken to minimize exposure when splitting tablets. Consult a physician in case of accidental ingestion by humans.
Convenient packaging
- Pink rectangular-shaped tablets
- Scored tablets are easy for horse owners to divide in half if needed
- Each tablet contains 1 mg of pergolide mesylate, so you always know how much your patient will get
- Packaged in convenient 10-tablet blister cards (plastic pockets sealed with aluminum foil)
- Blister cards are packaged in cartons containing either 60 or 160 tablets