Label: AMOXI-MAST- amoxicillin suspension
- NDC Code(s): 0061-8128-01
- Packager: Merck Sharp & Dohme Corp.
- Category: PRESCRIPTION ANIMAL DRUG LABEL
- DEA Schedule: None
- Marketing Status: New Animal Drug Application
Drug Label Information
Updated November 13, 2024
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- SPL UNCLASSIFIED SECTION
- SPL UNCLASSIFIED SECTION
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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.
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MECHANISM OF ACTION
ACTION: Amoxicillin trihydrate 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
- WARNINGS
- PRECAUTIONS
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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
- SPL UNCLASSIFIED SECTION
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PRINCIPAL DISPLAY PANEL - 10 mL Syringe Carton
Amoxi-Mast®
(amoxicillin intramammary infusion)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 syringesApproved by FDA under NADA # 055-100
MERCK
Animal Health -
INGREDIENTS AND APPEARANCE
AMOXI-MAST
amoxicillin suspensionProduct 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)