Prescription and Over-the-Counter Drugs

FDA is responsible for determining the marketing status (prescription or over-the-counter) of animal drug products based on whether or not it is possible to prepare ?adequate directions for use? under which a layperson can use the drugs safely and effectively. Products for which adequate directions for lay use can be written must be labeled for over-the-counter (OTC) use under existing law. If adequate directions cannot be written, the prescription (RX) system provides a method of distribution and control which is intended to assure that the RX product reaches only the hands of persons trained to use the product. This can include, in addition to the veterinarian, animal owners or managers whom the veterinarian has determined are capable of using the product safely under the practitioner?s supervision.

Safe use includes safety to the animal, safety of food products derived from the animal, safety to the person administering the drug, safety to persons associated with the animal, and safety in terms of the drug?s impact on the environment.

Effective use of a drug product assumes that an accurate diagnosis can be made with a reasonable degree of certainty, that the drug can be properly administered, and that the course of the disease can be followed so that the success or lack of success of the product can be observed.

The same drug substances can be marketed in a number of different dosage forms, intended for use by varying routes of administration, and in varying species of animals. Thus, these drug products may be labeled RX in some cases and OTC in others.

Prescription products must be labeled as follows: Caution: Federal law restricts this drug to use by or on the order of a licensed veterinarian.

Since adequate directions for safe and effective lay use cannot be written for veterinary prescription drug products, such products can only be sold to or on the prescription or other order of a licensed veterinarian. Sale of a veterinary prescription drug product to a layperson, except on a prescription or on order of a licensed practitioner, causes the product to be misbranded, and subjects the seller to civil and/or criminal provisions of the Federal Food, Drug, and Cosmetic Act. A licensed veterinarian may legally use or dispense a veterinary prescription drug product only within the course of his/her professional practice where a valid veterinarian-client-patient relationship exists. Veterinarians employed by drug manufacturers or distributors may not legally dispense prescription drug products to laypersons unless they meet the above criteria. Similarly, practicing veterinarians or their employees may not legally sell veterinary prescription drug products to walk-in customers unless a valid veterinarian-client-patient relationship exists.

Attached is a list of the drugs that are currently approved for use in horses. It includes the active ingredients and brand names of the drugs, and indicates whether the product may be sold over-the-counter (OTC) or by prescription (RX). This is not intended to be a complete list of active ingredients or brand names available on the market. The brand names are used as examples only and their listing in no way implies any product endorsement by the Food and Drug Administration. This listing is not intended to serve as an official reference for firms or individuals dealing with the Agency.

DRUGS APPROVED FOR HORSES

INJECTABLE USE

Active Ingredients

Brand Names

Acepromazine Maleate

Prom Ace Injectable (Rx)
Promazine Injectable (Rx)

Alfaprostol
Alfavet (Rx)

Aminopromazine fumerate

Jenatone Solution (Rx)

Ampicillin Sodium

Amp-Equine (Rx)

Benzathine Penicillin G
Procaine Penicillin G
Benza-Pen (R/O)
Bicillin Fortified (Rx)
Depo Pen (R/O)
Longicil Fortified (Rx)
Flo-Cillin/Dura-Biotic (R/O)

Beta-Aminopropionitrile
fumarate

Bapten (Rx)

Betamethasone Acetate
Betamethasone Disodium
Phosphate

Betavet Soluspan
Suspension (Rx)

Betamethasone Dipropionate
Betamethasone Sodium
Phosphate Betasone Aqueous
Suspension (Rx)

Boldenone Undecylenate

Equipoise (Rx)

Butorphanol Tartrate

Torbugesic (Rx)
Dolorex (Rx)

Ceftiofur Sodium

Naxcel Inj. (Rx)

Chloral Hydrate
Magnesium Sulfate
Pentobarbital

Chloropent (Rx)

Deslorelin Acetate

Ovuplant (Rx)

Detomidine Hydrochloride

Dormosedan (Rx)

Dexamethasone

Azium Aqueous Suspension (Rx)
Azium Solution (Rx)
Dexachel (Rx)
Dex-A-Vet (Rx)
Dexamethasone Injection (Rx)
Dexamethasone Solution (Rx)
Zonometh Solution (Rx)

Dexamethasone Phosphate

Dexamethasone Injection (Rx)

Dexamethasone Sodium
Phosphate

Dex-A-Vet Injection (Rx)
Dexamethasone Injection (Rx)

Dexamethasone-21 -
Isonicotinate

Voren Suspension (Rx)

Dihydrostreptomycin Sulfate

Dihydrostreptomycin (Rx)
Pfizer-Strep (Rx)

Dinoprost Tromethamine

Lutalyse Sterile Solution (Rx)
Prostin F2 Alpha (Rx)
ProstaMate (Rx)

Doxapram Hydrochloride

Dopram-V Injectable (Rx)

Doxylamine Succinate

A-H Injection (Rx)

Epinephrine
Lidocaine Hydrochloride

Lidocaine HCl with Epinephrine (Rx)

Flumethasone

Anaprime (Rx)
Flucort Solution (Rx)

Flunixin Meglumine

Banamine Solution (Rx)
Flunixin Meglumine Inj. (Rx)
Flunixin Meglumine Solution (Rx)
Flunixin Injection (Rx)

Fluprostenol Sodium

Equimate (Rx)

Follicle Stimulating
Hormone

F.S.H.-P Injectable (Rx)

Furosemide

Disal 5% Injection (Rx)
Furosemide Injection (Rx)
Lasix Injectable Solution (Rx)
Furos-A-Vet Inj. (Rx)

Guaifenesin

Guailaxin (Rx)
Gecolate Injection (Rx)
Glycodex Injection (Rx)

Hyaluronate Sodium

Equron (Rx)
Hyalovet (Rx)
Hylartin V (Rx)
Legend (Rx)
Synacid (Rx)

Hyaluronic Acid

Hyvisc (Rx)
Hyalovet (Rx)

Imidocarb Diproprionate

Imizole Equine Inj. (Rx)

Isoflupredone Acetate

Predef 2X (Rx)

Ketoprofen

Ketofen (Rx)

Luprostiol Sterile Sol.

Equestrolin (Rx)

Mepivacaine Hydrochloride

Mepivacaine HCl Inj. (Rx)

Methocarbamol

Robaxin-V Injectable (Rx)

Methylprednisolone Acetate

Depo-Medrol (Rx)
Methylprednisolone Acetate Inj. (Rx)

Naproxen

Equiproxin 10% Solution (Rx)

Neostigmine Methylsulfate

Stiglyn 1-500 (Rx)

Oleate Sodium

Osteum Solution 50 mg (Rx)

Orgotein

Palosein (Rx)

Oxytocin

Oxytocin Injection (Rx)
Xytocin Inject. (Rx)

Penicillin G Benzathine Penicillin G Procaine

Combicillin, Combicillin-AG (R/O)

Penicillin G Procaine

Pro-Pen G in Aqueous Susp. (R/O)

Pentazocine Lactate

Talwin-V (Rx)

Phenylbutazone

Bizolin Injection 20% (Rx)
Butazolidin Injectable (Rx)
Equi Bute Injection (Rx)
Equiphen (Rx)
Phen-Buta-Vet Inj. (Rx)
Phenylbutazone Inj. (Rx)
Robizone Injectable 20% (Rx)
Tevcodyne Injectable (Rx)
Therazone Inj. (Rx)

Pituitary Luteinizing
Hormone

P.L.H. Injectable (Rx)

Polysulfated Glycosamino-
glycan

Adequan Injectable (Rx)

Pralidoxime Chloride

Protopam (Rx)

Prednisolone

Ramosone (Rx)

Prednisolone Acetate

Meticortelone Susp. (Rx)

Prednisolone Sodium
Succinate

Prednisolone Inj. (Rx)
Solu-Delta Cortef (Rx)

Prednisolone Tertiary
Butylacetate

Hydeltrone-TBA
Suspension (Rx)

Prednisone

Meticorten (Rx)

Procaine Penicillin G

Crysticillin 300 A.S. Veterinary (R/O)
Crystaline Pro Penicillin G (Rx)
Microcillin-Ag (OTC)
Procaine Penicillin G (OTC)
Penicillin G Procaine (OTC)

Promazine Hydrochloride

Promazine Injectable (Rx)
Sparine Injection (Rx)
Tranquazine Injection (Rx)

Prostalene

Synchrocept Solution (Rx)

Pyrilamine Maleate

Histavet-P (Rx)
Pyrilamine Maleate Injection (Rx)

Selenium Vitamin E

E-SE (Rx)

Sodium Pentobarbital

Somnopentyl Injection (Rx)

Sodium Thiamylal

Anestatal Inj. (Rx)
Sodium Thiamylal Injection (Rx)
Surital (Rx)

Stanozolol

Winstrol-V (Rx)

Sulfadiazine
Trimethoprim

Di-Trim 48% Inj. (Rx)
Tribrissen 48% Inj. (Rx)

Sulfadimethoxine

Agribon Inj. 40% (R/O)

Tetracycline

Tetracycline Inj. (Rx)

Thialbarbitone Sodium

Kemithal L.A. (Rx)

Ticarcillin Disodium

Ticillin (Rx)

Tolazine Hydrochloride

Tolazine Injection (Rx)

Triamcinolone Acetonide

Triamcinolone Susp. (Rx)
Vetalog Inj. (Rx)

Triflupromazine
Hydrochloride

Vetame Inj. (Rx)

Tripelennamine Hydro-
chloride

Re-covr Injectable (Rx)

Xylazine Hydrochloride

Anased (Rx)
Chanizine Inj. (Rx)
Rompun Injectable (Rx)
Sedazine (Rx)

ORAL USE

Active Ingredients

Brand Names

Altrenogest