SURPASS- diclofenac sodium cream

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

DICLOFENAC SODIUM (UNII: QTG126297Q) (DICLOFENAC - UNII:144O8QL0L1)

Available from:

Boehringer Ingelheim Animal Health USA Inc.

INN (International Name):

DICLOFENAC SODIUM

Composition:

DICLOFENAC SODIUM 0.01 g in 1 g

Administration route:

TOPICAL

Prescription type:

PRESCRIPTION

Therapeutic indications:

SURPASS topical cream is indicated for the control of pain and inflammation associated with osteoarthritis (OA) in tarsal, carpal, metacarpophalangeal, metatarsophalangeal and proximal interphalangeal (hock, knee, fetlock and pastern) joints in horses. SURPASS topical cream is contraindicated in animals with known hypersensitivity to diclofenac.

Product summary:

SURPASS topical cream is white to pinkish-white and is packaged in 124-gram trilaminate tubes.

Authorization status:

New Animal Drug Application

Summary of Product characteristics

SURPASS- DICLOFENAC SODIUM CREAM
BOEHRINGER INGELHEIM ANIMAL HEALTH USA INC.
----------
SURPASS®
(1% DICLOFENAC SODIUM)
TOPICAL ANTI-INFLAMMATORY CREAM
FOR USE IN HORSES
VETERINARY PACKAGE INSERT
CAUTION:
Federal law restricts this drug to use by or on the order of a
licensed veterinarian.
DESCRIPTION:
SURPASS topical cream contains 1% diclofenac sodium. Diclofenac is a
non-steroidal
anti-inflammatory drug (NSAID) of the phenylacetic acid class. The
chemical name for
diclofenac is sodium [o- (2,6-dichloroanilino)phenyl] acetate. The
empirical formula is
C
H
Cl
NNaO and the molecular weight is 318.13. SURPASS topical cream
contains
1% diclofenac sodium in a base composed of Phospholipon 90H, propylene
glycol,
alcohol (5.94%), vitamin E acetate, benzethonium chloride and purified
water in the
Wisdom® liposomal formulation.
INDICATIONS:
SURPASS topical cream is indicated for the control of pain and
inflammation associated
with osteoarthritis (OA) in tarsal, carpal, metacarpophalangeal,
metatarsophalangeal and
proximal interphalangeal (hock, knee, fetlock and pastern) joints in
horses.
DOSAGE AND ADMINISTRATION:
Always provide the Client Information Sheet with the prescription.
_Dosage: _Apply a five-inch (5") ribbon of SURPASS topical cream twice
daily over the
affected joint for up to ten days.
_Administration: _Wear rubber gloves to prevent absorption into the
hands. Rub the
cream thoroughly into the hair covering the joint until it disappears.
CONTRAINDICATIONS:
SURPASS topical cream is contraindicated in animals with known
hypersensitivity to
diclofenac.
WARNINGS:
14
10
2
2
DO NOT USE IN HORSES INTENDED FOR HUMAN CONSUMPTION.
_User Safety: _Keep out of reach of children. Not for human use.
Consult a physician in
case of accidental ingestion by humans.
Wear gloves to prevent absorption into the hands. Direct contact with
the skin should
be avoided. If contact occurs, the skin should be washed immediately
with soap and
water.
_Animal Safety: _FOR TOPICAL USE IN HORSES ONLY. Owners should be
advised to observe
fo