ELOXIORAL- meloxicam suspension

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

meloxicam (UNII: VG2QF83CGL) (meloxicam - UNII:VG2QF83CGL)

Available from:

HENRY SCHEIN ANIMAL HEALTH

INN (International Name):

meloxicam

Composition:

meloxicam 1.5 mg in 1 mL

Administration route:

ORAL

Prescription type:

PRESCRIPTION

Therapeutic indications:

EloxiOral Oral Suspension is indicated for the control of pain and inflammation associated with osteoarthritis in dogs. Dogs with known hypersensitivity to meloxicam should not receive EloxiOral Oral Suspension. Do not use EloxiOral Oral Suspension in cats. Acute renal failure and death have been associated with the use of meloxicam in cats.

Product summary:

EloxiOral Oral Suspension 1.5 mg/mL: 10, 32 and 100 mL bottles with small and large dosing syringes. Storage: Store at controlled room temperature 68-77°F (20-25°C). Excursions permitted between 59°F and 86°F (15°C and 30°C). Brief exposure to temperature up to 104° F (40°C) may be tolerated provided the mean kinetic temperature does not exceed 77°F (25°C); however such exposure should be minimized. Distributed Exclusively by: Henry Schein Animal Health Dublin, OH 43017 www.henryscheinvet.com Made in the UK. Manufactured by: Norbrook ® Laboratories Limited Newry, Co. Down, BT35 6PU Northern Ireland

Authorization status:

Abbreviated New Animal Drug Application

Summary of Product characteristics

ELOXIORAL- MELOXICAM SUSPENSION
HENRY SCHEIN ANIMAL HEALTH
----------
HENRY SCHEIN
ANIMAL HEALTH
PROFESSIONAL INSERT
ANADA 200-497, Approved by FDA
ELOXIORAL™
(MELOXICAM)
1.5 MG/ML ORAL SUSPENSION
Non-steroidal anti-inflammatory drug for oral use in dogs only
CAUTION: Federal law restricts this drug to use by or on the order of
a licensed veterinarian.
WARNING: Repeated use of meloxicam in cats has been associated with
acute renal failure and
death. Do not administer additional injectable or oral meloxicam to
cats. See Contraindications,
Warnings, and Precautions for detailed information.
DES CRIPTION:
Meloxicam is a non-steroidal anti-inflammatory drug (NSAID) of the
oxicam class. Each milliliter of
EloxiOral
Oral Suspension contains meloxicam equivalent to 1.5 milligrams and
sodium benzoate (1.5
milligrams) as a preservative. The chemical name for Meloxicam is
-Hydroxy-2-methyl-N-(5-methyl-2-
thiazolyl)-2H-1,2-benzothiazine-3-carbox-amide-1, 1-dioxide. The
formulation is a yellowish viscous
suspension.
INDICATIONS :
EloxiOral Oral Suspension is indicated for the control of pain and
inflammation associated with
osteoarthritis in dogs.
DOSAGE AND ADMINISTRATION:
Always provide client information sheet with prescription. Carefully
consider the potential benefits and
risk of EloxiOral Oral Suspension and other treatment options before
deciding to use EloxiOral Oral
Suspension. Use the lowest effective dose for the shortest duration
consistent with individual response.
EloxiOral Oral Suspension should be administered initially at 0.09
mg/lb (0.2 mg/kg) body weight only
on the first day of treatment. For all treatments after day 1,
EloxiOral Oral Suspension should be
administered once daily at a dose of 0.045 mg/lb (0.1 mg/ kg). The
syringes are calibrated to deliver the
daily maintenance dose in lbs. Because the first dose (0.2 mg/kg) is
two times the amount of the daily
maintenance dose (0.1 mg/kg), two syringes containing the 0.1 mg/kg
dose should be administered at the
first dose.
®
TM
DIRECTIONS FOR ADMINISTR