Dinoprost Tromethamine (1 brand name, 1 dosage form, 1 route)
Available dosage forms: INJECTABLE.
Routes of administration: INJECTION.
Brand Names
- PROSTIN F2 ALPHA
Dosage and Administration
DOSAGE AND ADMINISTRATION As with any multi-dose vial, practice aseptic techniques in withdrawing each dose to decrease the possibility of post-injection bacterial infections. Adequately clean and disinfect the vial stopper prior to entry with a sterile needle and syringe. Use only sterile needles, and use each needle only once. Use within 3 months of first puncture and puncture a maximum of 20 times with a needle or 5 times with a dosage delivery device. When using a draw-off spike or needle with bore diameter larger than 4.90 mm, discard any product remaining in the vial immediately after use.
Warnings and Precautions
WARNINGS AND PRECAUTIONS User Safety: Not for human use. Keep out of the reach of children. Women of childbearing age, asthmatics, and persons with bronchial and other respiratory problems should exercise extreme caution when handling this product. In the early stages, women may be unaware of their pregnancies. Dinoprost tromethamine is readily absorbed through the skin and can cause abortion and/or bronchiospasms. Accidental spillage on the skin should be washed off immediately with soap and water. Contact Information: To report adverse reactions call Bimeda, Inc. at 1-888-524-6332. Residue Warnings: No milk discard or preslaughter drug withdrawal period is required for labeled uses in cattle. No preslaughter drug withdrawal period is required for labeled uses in swine. Use of this product in excess of the approved dose may result in drug residues. Do not use in horses intended for human consumption. Animal Safety Warnings: Severe localized clostridial infections associated with injection of ProstaMate have been reported. In rare instances, such infections have resulted in death. Aggressive antibiotic therapy should be employed at the first sign of infection at the injection site whether localized or diffuse. Do not administer intravenously (IV) as this route may potentiate adverse reactions. Non-steroidal anti-inflammatory drugs may inhibit prostaglandin synthesis; therefore this class of drugs should not be administered concurrently. Do not administer to pregnant cattle, unless abortion is desired. Cattle administered a progestin would be expected to have a reduced response to ProstaMate. Do not administer to sows and/or gilts prior to 3 days of normal predicted farrowing as an increased number of stillbirths and postnatal mortality may result. In mares, ProstaMate is ineffective when administered prior to day-5 after ovulation. Mare pregnancy status should be determined prior to treatment since dinoprost tromethamine injection has been reported to induce abortio
Adverse Reactions
ADVERSE REACTIONS Cattle: Limited salivation has been reported in some instances. Swine: The most frequently observed side effects were erythema and pruritus, slight incoordination, nesting behavior, itching, urination, defecation, abdominal muscle spasms, tail movements, hyperpnea or dyspnea, increased vocalization, salivation, and at the 100 mg (10x) dose only, possible vomiting. These side effects are transitory, lasting from 10 minutes to 3 hours, and were not detrimental to the health of the animal. Mares: The most frequently observed side effects are sweating and decreased rectal temperature. However, these have been transient in all cases observed and have not been detrimental to the animal. Other reactions seen have been increase in heart rate, increase in respiration rate, some abdominal discomfort, locomotor incoordination, and lying down. These effects are usually seen within 15 minutes of injection and disappear within one hour. Mares usually continue to eat during the period of expression of side effects. One anaphylactic reaction of several hundred mares treated with dinoprost tromethamine injection was reported but was not confirmed. CONTACT INFORMATIONTo report suspected adverse events, for technical assistance or to obtain a copy of the Safety Data Sheet (SDS) contact Bimeda, Inc. at 1-888-524-3222. For additional information about adverse drug experience reporting for animal drugs, contact FDA at 1-888-FDA-VETS or online at www.fda.gov/reportanimalae.