Animal NDC 0061-8128-01 Amoxi-mast

Amoxicillin

Animal Product Information

Field Name	Field Value
Animal NDC Code	0061-8128-01
Proprietary Name	Amoxi-mast What is the Proprietary Name? The proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.
Non-Proprietary Name	Amoxicillin What is the Non-Proprietary Name? The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.
Labeler Name	Merck Sharp & Dohme Corp.
Product Type	Prescription Animal Drug
Usage Information	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.
Active Ingredient(s)	Amoxicillin
Marketing Category	NADA - NEW ANIMAL DRUG APPLICATION What is the Marketing Category? Product types are broken down into several potential Marketing Categories, such as NDA/ANDA/BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.
FDA Application Number	NADA055100 What is the FDA Application Number? This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null.

Amoxi-mast Images

Amoxi-mast Animal Product Labeling Information

The product labeling information includes all published material associated to a drug. Product labeling documents include information like generic names, active ingredients, ingredient strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.

Other
Description
Mechanism Of Action
Indications & Usage
Warnings
Precautions
Dosage & Administration
How Supplied
Storage And Handling
Principal Display Panel - 10 Ml Syringe Carton

Other

LACTATING COW FORMULA
(FÓRMULA PARA VACAS LACTANTES)

Intramammary Infusion
(Infusión intramamaria)

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

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

Approved by FDA under NADA # 055-100

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

Rev 10/2022

INS15427 04

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 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

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.

Storage And Handling

Do Not Store Above 24°C (75°F)

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 syringes