REVOLUTION PLUS: Product Information (Page 3 of 3)

ANIMAL SAFETY:

Margin of Safety Studies: One exploratory and two pivotal margin of safety studies were conducted with REVOLUTION PLUS. In the first study, REVOLUTION PLUS was applied topically to kittens eight weeks of age at doses of 12/2 (selamectin/sarolaner) mg/kg (1X), 36/6 mg/kg (3X), 45/7.5 mg/kg (3.75X), and 60/10 mg/kg (5X) every 28 days for eight consecutive doses. One female cat in the 3.75X group was found dead on study day 115. The cause was determined to be hemorrhage in multiple tissues secondary to a low platelet count. The role of the drug in contributing to this event is undetermined. No significant changes related to REVOLUTION PLUS were observed among the remaining cats for physical examination, body weight, clinical pathology (hematology, coagulation, and serum chemistry), gross pathology, histopathology or organ weights.

In the second study, REVOLUTION PLUS was applied topically to cats 9 months of age at doses of 1X, 3X, and 5X every 28 days for six consecutive doses. Cosmetic changes at the application site occurred sporadically in all treatment groups and included wet appearance and dried white material. Hair loss at the dose site was also noted in two cats in the 1X group and one cat in the 5X group within 1-8 days after the fourth dose administered on day 84. No significant changes related to REVOLUTION PLUS were observed for physical examination, body weight, clinical pathology (hematology, coagulation, and serum chemistry).

During an exploratory margin of safety study, one cat in the 60 mg/kg/ 10 mg/kg (selamectin/sarolaner) group (5X dose group) experienced piloerection, tremors, and mydriasis approximately 24 hours after receiving the third monthly dose of the combination. Signs resolved without treatment within 2 hours. This cat completed the study, receiving 3 subsequent 5X doses with no abnormal observations.

Oral safety study: The safety of REVOLUTION PLUS administered orally to kittens was tested in case of accidental oral ingestion. Oral administration of the highest recommended topical dose of REVOLUTION PLUS to kittens resulted in transient lower food consumption and clinical findings of emesis, soft feces, and salivation. In one male, mild tremor was observed and resolved within 3 hours after dosing; the same cat demonstrated reduced activity approximately 6 hours after dosing.

Heartworm Positive Cat Safety of Selamectin: Selamectin is the active ingredient in REVOLUTION PLUS that prevents heartworm disease in cats; it has been shown that the addition of sarolaner does not interfere with this activity. In a safety study in which selamectin topical solution was applied at 4 times the recommended dose to patent heartworm infected cats, no adverse reactions were observed.

Field safety: In three well-controlled field studies, REVOLUTION PLUS was used concurrently with other medications, such as vaccines, cestocidal anthelmintics, antibacterials, sedatives, anesthetics, opioid analgesics, corticosteroids, and non-steroidal anti-inflammatories. No adverse reactions were associated with the concurrent use of REVOLUTION PLUS and other medications.

STORAGE CONDITIONS:

Store at or below 30°C (86°F).

HOW SUPPLIED:

Available in three separate dose strengths for cats of different weights (see DOSAGE AND ADMINISTRATION). REVOLUTION PLUS is available in cartons containing one, three, or six single dose tubes. The amount of liquid in tube varies for each weight range (2.8 — 5.5 lbs, 5.6 — 11 lbs, 11.1- 22 lbs).
Tubes are never completely filled.

Approved by FDA under NADA # 141-502
Revised: January 2023
zoetis
Distributed by:
Zoetis Inc.
Kalamazoo, MI 4900740041782

PRINCIPAL DISPLAY PANEL — 0.25 3-pack Carton

51497001

0.25 3-pack Carton
(click image for full-size original)

PRINCIPAL DISPLAY PANEL — 0.5 3-pack Carton

51496901

0.5 3-pack Carton
(click image for full-size original)

PRINCIPAL DISPLAY PANEL — 1 mL 3-pack Carton

51496501

1 mL 3-pack Carton
(click image for full-size original)

REVOLUTION PLUS selamectin and sarolaner solution
Product Information
Product Type PRESCRIPTION ANIMAL DRUG Item Code (Source) NDC:54771-0411
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
SAROLANER (SAROLANER) SAROLANER 10 mg in 1 mL
SELAMECTIN (SELAMECTIN) SELAMECTIN 60 mg in 1 mL
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:54771-0411-1 3 TUBE in 1 CARTON contains a TUBE
1 0.25 mL in 1 TUBE This package is contained within the CARTON (54771-0411-1)
2 NDC:54771-0411-2 6 TUBE in 1 CARTON contains a TUBE
2 0.25 mL in 1 TUBE This package is contained within the CARTON (54771-0411-2)
3 NDC:54771-0411-3 1 TUBE in 1 CARTON contains a TUBE
3 0.25 mL in 1 TUBE This package is contained within the CARTON (54771-0411-3)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NADA NADA141502 11/29/2018
REVOLUTION PLUS selamectin and sarolaner solution
Product Information
Product Type PRESCRIPTION ANIMAL DRUG Item Code (Source) NDC:54771-0412
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
SAROLANER (SAROLANER) SAROLANER 10 mg in 1 mL
SELAMECTIN (SELAMECTIN) SELAMECTIN 60 mg in 1 mL
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:54771-0412-3 1 TUBE in 1 CARTON contains a TUBE
1 .5 mL in 1 TUBE This package is contained within the CARTON (54771-0412-3)
2 NDC:54771-0412-1 3 TUBE in 1 CARTON contains a TUBE
2 0.5 mL in 1 TUBE This package is contained within the CARTON (54771-0412-1)
3 NDC:54771-0412-2 6 TUBE in 1 CARTON contains a TUBE
3 0.5 mL in 1 TUBE This package is contained within the CARTON (54771-0412-2)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NADA NADA141502 11/29/2018
REVOLUTION PLUS selamectin and sarolaner solution
Product Information
Product Type PRESCRIPTION ANIMAL DRUG Item Code (Source) NDC:54771-0416
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
SELAMECTIN (SELAMECTIN) SELAMECTIN 60 mg in 1 mL
SAROLANER (SAROLANER) SAROLANER 10 mg in 1 mL
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:54771-0416-1 3 TUBE in 1 CARTON contains a TUBE
1 1 mL in 1 TUBE This package is contained within the CARTON (54771-0416-1)
2 NDC:54771-0416-2 6 TUBE in 1 CARTON contains a TUBE
2 1 mL in 1 TUBE This package is contained within the CARTON (54771-0416-2)
3 NDC:54771-0416-3 1 TUBE in 1 CARTON contains a TUBE
3 1 mL in 1 TUBE This package is contained within the CARTON (54771-0416-3)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NADA NADA141502 11/29/2018
Labeler — Zoetis Inc. (828851555)

Revised: 12/2023 Zoetis Inc.

Page 3 of 3 1 2 3

VetLabel.com provides trustworthy package insert and label information about marketed drugs as submitted by manufacturers to the U.S. Food and Drug Administration. Package information is not reviewed or updated separately by VetLabel.com. Every individual animal healthcare product label entry contains a unique identifier which can be used to secure further details directly from the U.S. National Institutes of Health and/or the FDA.

Our database mirrors the FDA's central repository of drug labels and package inserts under the Structured Product Labeling standard. VetLabel.com provides the full animal health subset of the FDA's repository. Veterinary information provided here is not intended as a substitute for direct consultation with a qualified veterinary professional.

Terms of Use | Copyright © 2024. All Rights Reserved.