AMOXI-MAST- amoxicillin suspension

Amoxi-Mast by

Drug Labeling and Warnings

Amoxi-Mast by is a Animal medication manufactured, distributed, or labeled by Merck Sharp & Dohme Corp.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

LACTATING COW FORMULA
(FÓRMULA PARA VACAS LACTANTES)

Intramammary Infusion
(Infusión intramamaria)

SPL UNCLASSIFIED SECTION

CAUTION: Federal law restricts this drug to use by or on the order of a licensed veterinarian.

Amoxi-Mast (amoxicillin) is specially prepared for the treatment of bovine mastitis in lactating cows.

DESCRIPTION

DESCRIPTION: Amoxi-Mast is a stable, nonirritating suspension of amoxicillin trihydrate containing the equivalent of 62.5 mg of amoxicillin per disposable syringe. Amoxi-Mast is manufactured by a nonsterilizing process.

Amoxicillin trihydrate is a semisynthetic penicillin derived from the penicillin nucleus, 6-amino-penicillanic acid. Chemically, it is D(-)-α-amino-p-hydroxybenzyl penicillin trihydrate.

MECHANISM OF ACTION

ACTION: Amoxicillin is bactericidal in action against susceptible organisms. It is a broad-spectrum antibiotic which is effective against common infectious mastitis pathogens, namely Streptococcus agalactiae and penicillin-sensitive Staphylococcus aureus.

In vitro studies have demonstrated the susceptibility of the following strains of bacteria: α- and β-haemolytic streptococci, nonpenicillinase-producing staphylococci, and Escherichia coli. Susceptibility has not been demonstrated against penicillinase-producing bacteria, particularly resistant staphylococci. Most strains of Pseudomonas, Klebsiella, and Enterobacter are resistant. The clinical or subclinical significance of these in vitro studies is not known.

INDICATIONS & USAGE

INDICATIONS: Amoxi-Mast is indicated in the treatment of subclinical infectious bovine mastitis in lactating cows due to Streptococcus agalactiae and penicillin-sensitive Staphylococcus aureus. Early detection and treatment of mastitis is advised.

WARNINGS

WARNINGS: Milk taken from animals during treatment and for 60 hours (5 milkings) after the last treatment must not be used for food. Treated animals must not be slaughtered for food purposes within 12 days after the last treatment.

PRECAUTIONS

PRECAUTION: Because it is a derivative of 6-amino-penicillanic acid, Amoxi-Mast has the potential for producing allergic reactions. Such reactions are rare; however, should they occur, the subject should be treated with the usual agents (antihistamines, pressor amines).

DOSAGE & ADMINISTRATION

DOSAGE AND ADMINISTRATION: Milk out udder completely. Wash udder and teats thoroughly with warm water containing a suitable dairy antiseptic. Dry thoroughly. Clean and disinfect the teat with alcohol swabs provided in the carton. Remove the syringe tip cover and insert the tip of the syringe into the teat orifice. Express the suspension into the quarter with gentle and continuous pressure. Withdraw the syringe and grasp the end of the teat firmly. Massage the medication up into the milk cistern.

For optimum response, the drug should be administered by intramammary infusion in each infected quarter as described above. Treatment should be repeated at 12-hour intervals for a total of 3 doses. At the next routine milking after the last dose, the treated quarter should be milked out and the milk discarded.

Each carton contains 12 alcohol swabs to facilitate proper cleaning and disinfecting of the teat orifice.

HOW SUPPLIED

HOW SUPPLIED: Amoxi-Mast is supplied in cartons of 12 single-dose syringes with 12 alcohol swabs. Each 10-mL, disposable syringe contains amoxicillin trihydrate equivalent to 62.5 mg of amoxicillin activity.

Do Not Store Above 24°C (75°F)

SPL UNCLASSIFIED SECTION

NADA #55-100, Approved by FDA

Manufactured by:
G.C. Hanford Mfg. Co.
Syracuse, NY 13201

© 2015 Intervet Inc., a subsidiary of Merck & Co., Inc.,
Madison, NJ 07940, USA.
All rights reserved. 01/15

INS15427 02

F-27864503

MERCK
Animal Health

PRINCIPAL DISPLAY PANEL - 10 mL Syringe Carton

Amoxi-Mast®
(amoxicillin)

LACTATING COW FORMULA

Intramammary Infusion

short tip

60-HOUR MILKOUT

Caution: Federal law restricts this drug to use by
or on the order of a licensed veterinarian.

12 single-dose (10 mL),
disposable syringes

NADA #55-100, Approved by FDA

MERCK
Animal Health

INGREDIENTS AND APPEARANCE

AMOXI-MAST 
amoxicillin suspension

Product Information
Product Type	PRESCRIPTION ANIMAL DRUG	Item Code (Source)	NDC: 0061-8128
Route of Administration	INTRAMAMMARY

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Amoxicillin (UNII: 804826J2HU) (Amoxicillin Anhydrous - UNII:9EM05410Q9)	Amoxicillin Anhydrous	62.5 mg  in 10 mL

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0061-8128-01	12 in 1 CARTON
1		10 mL in 1 SYRINGE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
NADA	NADA055100	11/16/1984

Labeler - Merck Sharp & Dohme Corp. (001317601)