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Roxee Medication Guide

Dinoprost Tromethamine

Medication reference facts with explicit FDA-approval, off-label, source-limited, and safety context. Roxee does not sell, prescribe, or dispense medications.

Both Reference complete Livestock/food-animal use Rx required Liquid (Solution) Multiple FDA labelers Official label facts Owner quick guide first
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Dinoprost Tromethamine

Dinoprost Tromethamine

Drug type: Food-animal record • Branded profile • Livestock/food-animal use

Both Liquid (Solution) Rx required 100% reference complete

Species: Both

Approval status: Food-animal or livestock record. This source record is for livestock or food-animal use, not a dog/cat medication profile. Food-animal rules, withdrawal intervals, and residue restrictions may apply.

Medication Snapshot

Merged from the current Roxee medication system with field-level provenance, freshness, and completeness tracking.

Dinoprost Tromethamine

For its luteolytic effect to control timing of estrus in estrus cycling mares and in clinically anestrous mares that have a corpus luteum. For use with EAZI-BREED CIDR (progesterone intravaginal insert) Cattle Insert for synchronization of estrus in suckled beef cows and replacement beef and dairy heifers, advancement of first postpartum estrus in suckled beef cows, and advancement of first pubertal estrus in beef heifers. For abortion in beef cows, beef heifers and replacement dairy heifers. Species commonly shown: Both, Horse, Mares, Not For Food, Gilts.

Generic name
Dinoprost Tromethamine
Brand names
Prostin F2 Alpha® Sterile Solution, Lutalyse® Injection, LUTALYSE® HighCon Injection, ProstaMate®
Manufacturer
Multiple FDA labelers
Species
Both, Horse, Gilts, Sows
Dosage forms
Liquid (Solution), Injectable Solution
Prescription
Prescription required
Completeness
100%
Validation
Complete
Brand names
Prostin F2 Alpha® Sterile Solution Lutalyse® Injection LUTALYSE® HighCon Injection ProstaMate® Lutalyse Sterile Dinoprost Tromethamine Lutalyse HighCon Sterile ProstaMate Sterile
Dosage forms
Liquid (Solution) Injectable Solution

Indications / Uses

For its luteolytic effect to control timing of estrus in estrus cycling mares and in clinically anestrous mares that have a corpus luteum. For use with EAZI-BREED CIDR (progesterone intravaginal insert) Cattle Insert for synchronization of estrus in suckled beef cows and replacement beef and dairy heifers, advancement of first postpartum estrus in suckled beef cows, and advancement of first pubertal estrus in beef heifers. For abortion in beef cows, beef heifers and replacement dairy heifers.

Warnings / Contraindications

Not for use in horses intended for food. Federal law restricts this drug to use by or on the order of a licensed veterinarian. Women of child-bearing age, asthmatics, and persons with bronchial and other respiratory problems should exercise extreme caution when handling this product. Dinoprost tromethamine is readily absorbed through the skin and can cause abortion and bronchiospasms. Accidental spillage on the skin should be washed off immediately with soap and water. Use of this product in excess of the approved dose may result in drug residues. Do not administer intravenously; this may potentiate adverse reactions. Administer one EAZI-BREED CIDR Cattle Insert per animal for 7 days (for example, if administered on a Monday remove on the following Monday). Administer a dose of 2 mL LUTALYSE HighCon Injection (25 mg dinoprost) by intramuscular or subcutaneous injection 1 day prior to EAZI-BREED CIDR Cattle Insert removal, on Day 6 of the 7 Day administration period. Observe animals for signs of estrus on Days 1 to 3 after removal of the EAZI-BREED CIDR Cattle Insert and inseminate animals about 12 hours after onset of estrus. Federal law restricts this drug to use by or on the order of a licensed veterinarian. Not for human use. Keep out of the reach of children. Women of childbearing age, asthmatics, or 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. LUTALYSE HighCon Injection is indicated for its abortifacient effect in beef cows, beef heifers and replacement dairy heifers during the first 100 days of gestation. Cattle that abort will abort within 35 days of injection. Federal law restricts this drug to use by or on the order of a licensed veterinarian. Not for human use. Keep out of the reach of children. Women of childbearing age, asthmatics, or 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.

  • Not for use in horses intended for food. Federal law restricts this drug to use by or on the order of a licensed veterinarian. Women of child-bearing age, asthmatics, and persons with bronchial and other respiratory problems should exercise extreme caution when handling this product. Dinoprost tromethamine is readily absorbed through the skin and can cause abortion and bronchiospasms. Accidental spillage on the skin should be washed off immediately with soap and water. Use of this product in excess of the approved dose may result in drug residues. Do not administer intravenously; this may potentiate adverse reactions. Administer one EAZI-BREED CIDR Cattle Insert per animal for 7 days (for example, if administered on a Monday remove on the following Monday). Administer a dose of 2 mL LUTALYSE HighCon Injection (25 mg dinoprost) by intramuscular or subcutaneous injection 1 day prior to EAZI-BREED CIDR Cattle Insert removal, on Day 6 of the 7 Day administration period. Observe animals for signs of estrus on Days 1 to 3 after removal of the EAZI-BREED CIDR Cattle Insert and inseminate animals about 12 hours after onset of estrus. Federal law restricts this drug to use by or on the order of a licensed veterinarian. Not for human use. Keep out of the reach of children. Women of childbearing age, asthmatics, or 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. LUTALYSE HighCon Injection is indicated for its abortifacient effect in beef cows, beef heifers and replacement dairy heifers during the first 100 days of gestation. Cattle that abort will abort within 35 days of injection. Federal law restricts this drug to use by or on the order of a licensed veterinarian. Not for human use. Keep out of the reach of children. Women of childbearing age, asthmatics, or 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.

Side Effects

Top reported reactions (openFDA): Vomiting, Drooling, Itching, Lack of efficacy - NOS, Tachypnoea, Constricted pupils.

FAQ

Both, Horse, Mares, Not For Food, Gilts, Sows, Replacement Dairy Heifers, Beef cows, Beef heifers, Dairy, lactating, Mares, Replacement And Dairy Heifers, Dairy cows, Replacement beef and dairy heifers

Yes. Roxee shows this as prescription-only.

Liquid (Solution), Injectable Solution

Related Conditions

Asthma (cats) Metritis Pyometra (Uterine Infection)

Source Transparency

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Pet Owner Quick Guide

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Used for:

For estrus synchronization in beef cows, beef heifers and replacement dairy heifers

Dosing note:

Exact dosing depends on your pet's species, weight, and health status. Use your veterinarian's instructions for the exact dose and schedule.

What to watch for:

  • Not for use in horses intended for food
  • Women of child-bearing age, asthmatics, and persons with bronchial and other respiratory problems should exercise extreme caution when handling this product
  • Dinoprost tromethamine is readily absorbed through the skin and can cause abortion and bronchiospasms
  • Accidental spillage on the skin should be washed off immediately with soap and water
  • Use of this product in excess of the approved dose may result in drug residues
  • Do not administer intravenously
  • this may potentiate adverse reactions
  • Administer one EAZI-BREED CIDR Cattle Insert per animal for 7 days (for example, if administered on a Monday remove on the following Monday)
  • Administer a dose of 2 mL LUTALYSE HighCon Injection (25 mg dinoprost) by intramuscular or subcutaneous injection 1 day prior to EAZI-BREED CIDR Cattle Insert removal, on Day 6 of the 7 Day administration period
  • Observe animals for signs of estrus on Days 1 to 3 after removal of the EAZI-BREED CIDR Cattle Insert and inseminate animals about 12 hours after onset of estrus
  • Not for human use
  • Keep out of the reach of children
  • Women of childbearing age, asthmatics, or 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
  • LUTALYSE HighCon Injection is indicated for its abortifacient effect in beef cows, beef heifers and replacement dairy heifers during the first 100 days of gestation
  • Cattle that abort will abort within 35 days of injection
  • Vomiting (1 reports)
  • Vaginal discharge (1 reports)
  • Tachypnoea (1 reports)

When to call the vet:

  • Repeated vomiting or diarrhea.
  • Severe lethargy (hard to wake, very low energy).
  • Collapse or fainting.
  • Trouble breathing.
  • Facial swelling or hives.
  • Blood in vomit or stool.

Regulatory restrictions are shown in Vet View.

What to tell or ask your vet today:

  • Is this medicine the right fit for my pet’s current symptoms?
  • Which warning signs mean I should call back right away?
  • How should I handle missed doses or refusal to take the medicine?

Next actions

Talk to a Vet / Find a Vet Near You Save to pet meds Share page Review report evidence
Research brief

Medication Research Insights

A source-aware map of what to know, what is uncertain, and what to verify with your veterinarian.

Source Backed Signals

What to know

Evidence-backed context Limited

Roxee has limited cited overview evidence for Dinoprost Tromethamine; use the official documents and your veterinarian's instructions for product-specific decisions.

Source: openFDA case USA-USFDACVM-2016-US-058187
Safety signal coverage Reported signals

7 tracked reaction signals; 7 reported cases; 5 serious reports; 2 species groups. These are reporting and label-derived signals for interpretation with a veterinarian.

Source: openFDA case USA-USFDACVM-2016-US-058187
Interpretation guardrail Not causation

Adverse-event reports help form a watch list, but they do not prove the medication caused the reaction and they are not a risk ranking between medications.

Evidence tension

Stronger signal Label / review

Official labels, package inserts, and reviewed summaries carry more weight than isolated reports.

Source: openFDA case USA-USFDACVM-2016-US-058187
Weaker signal Reported data

Case reports and openFDA terms are useful for pattern awareness, but they are incomplete, can include multiple exposures, and do not estimate an individual pet's probability of harm.

Reaction signal map

Most reported reactions Top terms

Vomiting (1 reports), Vaginal discharge (1 reports), Tachypnoea (1 reports), Itching (1 reports), Drooling (1 reports)

Body systems represented Signal grouping

Digestive (2), Skin & allergy (1), Effectiveness (1), Other (3)

Species and breed lens

Species represented in reports Species lens

Dog (5 reports), Cat (2 reports)

What your vet may verify

Fit for this patient Vet check

Verify whether Dinoprost Tromethamine fits the pet's species, current diagnosis, age, weight, organ status, pregnancy/lactation status, and concurrent medications.

Evidence limitations Evidence review

Separate label-backed warnings from adverse-event reports and owner observations before changing the plan.

What to watch next

Watch list Owner-safe

Not for use in horses intended for food, Women of child-bearing age, asthmatics, and persons with bronchial and other respiratory problems sh, Dinoprost tromethamine is readily absorbed through the skin and can cause abortion and bronchiospasm, Accidental spillage on the skin should be washed off immediately with soap and water, Use of this product in excess of the approved dose may result in drug residues

Call sooner if Escalation

Repeated vomiting or diarrhea. Severe lethargy (hard to wake, very low energy). Collapse or fainting.

Bottom line: Use this Dinoprost Tromethamine brief as a structured watch list and source map, not as a reason to start, stop, or change treatment without your veterinarian.
Vet source depth
  1. openFDA case USA-USFDACVM-2016-US-058187 · adverse_reaction · adverse reactions
  2. Contraindication source · fda_animal_drugs · warnings contraindications
  3. FDA application profile · official_label · quick facts
  4. FDA application profile · official_label · quick facts
  5. Medication usage source · fda_animal_drugs · quick facts
  6. FOI · document · documents
  7. SPL · document · documents
  8. FOI · document · documents

Evidence

Review status / Updated / Sources

Review status: Clinical reviewer not listed

Updated: February 12, 2026, 10:44 PM UTC

Sources:
Safety & side effects

Side effects to monitor:

  • Not for use in horses intended for food
  • Women of child-bearing age, asthmatics, and persons with bronchial and other respiratory problems should exercise extreme caution when handling this product
  • Dinoprost tromethamine is readily absorbed through the skin and can cause abortion and bronchiospasms
  • Accidental spillage on the skin should be washed off immediately with soap and water
  • Use of this product in excess of the approved dose may result in drug residues

Most reported reactions:

  • Vomiting (1 reports)
  • Vaginal discharge (1 reports)
  • Tachypnoea (1 reports)

Emergency warning signs:

  • Repeated vomiting or diarrhea.
  • Severe lethargy (hard to wake, very low energy).
  • Collapse or fainting.
  • Trouble breathing.
Talk to a Vet / Find a Vet Near You Start Symptom Intake

Vet Fast Scan

Source-backed clinical checkpoints for quick review.

FDA-labeled species
Beef cows, Beef heifers, Dairy, Dairy cows, Gilts, Horse, Mares, Replacement And Dairy Heifers, Replacement Dairy Heifers, Replacement beef and dairy heifers, Sows
Indication / use
For estrus synchronization in beef cows, beef heifers and replacement dairy heifers
Form / route / dose
Form: Injectable Solution, Liquid (Solution)
Route: Intramuscular, Subcutaneous
Confirm product label and patient-specific plan.
Warnings
  • High: Not for use in horses intended for food. Federal law restricts this drug to use by or on the order of a licensed veteri…
Adverse-event caveat
No stored openFDA case explorer rows are linked yet.
Source docs

Quick Facts

Official label facts first, then secondary summaries. Marketing content is separated below.

Species: Both
Manufacturer: Multiple FDA labelers
Form: Injectable Solution, Liquid (Solution)
Identifiers:
ANADA: 200253 NADA: 100202 NADA: 108901 NADA: 141442 NDC Package: 54771-1327-1 NDC Package: 54771-1327-2 NDC Package: 54771-1327-3 NDC Package: 54771-1328-1 NDC Package: 54771-1328-2 NDC Package: 54771-1328-3 NDC Package: 61133-4001-1 NDC Package: 82231-105-00 NDC Product: 54771 NDC Product: 61133 NDC Product: 82231
Source metadata:

Warnings / Contraindications

Not for use in horses intended for food. Federal law restricts this drug to use by or on the order of a licensed veterinarian. Women of child-bearing age, asthmatics, and persons with bronchial and other respiratory problems should exercise extreme caution when handling this product. Dinoprost tromethamine is readily absorbed through the skin and can cause abortion and bronchiospasms. Accidental spillage on the skin should be washed off immediately with soap and water. Use of this product in excess of the approved dose may result in drug residues. Do not administer intravenously; this may potentiate adverse reactions. Administer one EAZI-BREED CIDR Cattle Insert per animal for 7 days (for example, if administered on a Monday remove on the following Monday). Administer a dose of 2 mL LUTALYSE HighCon Injection (25 mg dinoprost) by intramuscular or subcutaneous injection 1 day prior to EAZI-BREED CIDR Cattle Insert removal, on Day 6 of the 7 Day administration period. Observe animals for signs of estrus on Days 1 to 3 after removal of the EAZI-BREED CIDR Cattle Insert and inseminate animals about 12 hours after onset of estrus. Federal law restricts this drug to use by or on the order of a licensed veterinarian. Not for human use. Keep out of the reach of children. Women of childbearing age, asthmatics, or 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. LUTALYSE HighCon Injection is indicated for its abortifacient effect in beef cows, beef heifers and replacement dairy heifers during the first 100 days of gestation. Cattle that abort will abort within 35 days of injection. Federal law restricts this drug to use by or on the order of a licensed veterinarian. Not for human use. Keep out of the reach of children. Women of childbearing age, asthmatics, or 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.

  • High: Not for use in horses intended for food. Federal law restricts this drug to use by or on the order of a licensed veterinarian. Women of child-bearing age, asthmatics, and persons with bronchial and other respiratory problems should exercise extreme caution when handling this product. Dinoprost tromethamine is readily absorbed through the skin and can cause abortion and bronchiospasms. Accidental spillage on the skin should be washed off immediately with soap and water. Use of this product in excess of the approved dose may result in drug residues. Do not administer intravenously; this may potentiate adverse reactions. Administer one EAZI-BREED CIDR Cattle Insert per animal for 7 days (for example, if administered on a Monday remove on the following Monday). Administer a dose of 2 mL LUTALYSE HighCon Injection (25 mg dinoprost) by intramuscular or subcutaneous injection 1 day prior to EAZI-BREED CIDR Cattle Insert removal, on Day 6 of the 7 Day administration period. Observe animals for signs of estrus on Days 1 to 3 after removal of the EAZI-BREED CIDR Cattle Insert and inseminate animals about 12 hours after onset of estrus. Federal law restricts this drug to use by or on the order of a licensed veterinarian. Not for human use. Keep out of the reach of children. Women of childbearing age, asthmatics, or 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. LUTALYSE HighCon Injection is indicated for its abortifacient effect in beef cows, beef heifers and replacement dairy heifers during the first 100 days of gestation. Cattle that abort will abort within 35 days of injection. Federal law restricts this drug to use by or on the order of a licensed veterinarian. Not for human use. Keep out of the reach of children. Women of childbearing age, asthmatics, or 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.
Source metadata:

Adverse Reactions

Snapshot first, detailed rows second. This section summarizes signal data and is not a diagnosis.

Tap or hover a reaction to see what it means in plain language.

Tracked signals
7
Reported cases
7
Serious reports
5
Species represented
2
Grouped by Body System
Digestive (2) · Vomiting, Drooling Skin & allergy (1) · Itching Effectiveness (1) · Lack of efficacy - NOS Other (3) · Vaginal discharge, Tachypnoea, Constricted pupils
Most Reported Reactions
Reaction Body system Cases Species Serious cases
Digestive 1 Dog 1
Other 1 Cat 1
Other 1 Dog 1
Skin & allergy 1 Dog 1
Digestive 1 Dog 1
Effectiveness 1 Dog 0
Other 1 Cat 0

Species coverage: Dog (5) Cat (2)

View detailed reaction table
Reaction Body system Species Seriousness Frequency Reports
Digestive Dog Serious - 1
Other Cat Serious - 1
Other Dog Serious - 1
Effectiveness Dog Non-serious - 1
Skin & allergy Dog Serious - 1
Digestive Dog Serious - 1
Other Cat Non-serious - 1
Source metadata:

Source Documents

The most useful source links appear first; full previews and metadata stay in the veterinary/professional layer.

Use original documents to confirm product-specific warnings, ingredients, and handling details with your veterinarian.

Lutalyse® Injection SPL · SPL ProstaMate® SPL · SPL LUTALYSE® HighCon Injection SPL · SPL

Full source previews and metadata remain in the veterinary/professional layer.

Owner handouts

0
No owner handouts linked yet.

Official label / PI

0
No official label or package insert links yet.

SPL

8

FOI

5

Lutalyse® Injection

SPL · SPL

Open original
FDA Structured Product Label

Lutalyse® Injection

Rendered from Roxee's cached FDA SPL package contents for on-page reading. Use Open original for the raw FDA ZIP/XML source.

Sponsor
Zoetis Inc.
NADA
108-901
Status
RX
Form
Injectable Solution
Route
Intramuscular
Species
Gilts • Sows • Replacement Dairy Heifers • Beef cows • Beef heifers • Dairy • Mares
Composition / specifications
Each milliliter of sterile solution contains the equivalent of 5 milligrams of dinoprost.

Beef Cows, Beef Heifers and Replacement Dairy Heifers

Indication

For estrus synchronization in beef cows, beef heifers and replacement dairy heifers

Dosage

LUTALYSE Injection is used to control the timing of estrus and ovulation in estrous cycling cattle that have a corpus luteum. Inject a dose of 5 mL LUTALYSE Injection (25 mg dinoprost) intramuscularly either once or twice at a 10 to 12 day interval. With the single injection, cattle should be bred at the usual time relative to estrus. With the two injections cattle can be bred after the second injection either at the usual time relative to detected estrus or at about 80 hours after the second injection of LUTALYSE Injection. Estrus is expected to occur 1 to 5 days after injection if a corpus luteum was present. Cattle that do not become pregnant to breeding at estrus on days 1 to 5 after injection will be expected to return to estrus in about 18 to 24 days.

Indication

For abortion in beef cows, beef heifers and replacement dairy heifers

Dosage

Inject a dose of 25 mg dinoprost (5 mL) intramuscularly during the first 100 days of gestation. Cattle that abort will abort within 35 days of injection.

Label highlights

Indication

For use with EAZI-BREED™ CIDR® (progesterone intravaginal insert) Cattle Insert for synchronization of estrus in suckled beef cows and replacement beef and dairy heifers, advancement of first postpartum estrus in suckled beef cows, and advancement of first pubertal estrus in beef heifers

Dosage
  • Administer one EAZI-BREED CIDR Cattle Insert per animal for 7 days (for example, if administered on a Monday remove on the following Monday).
  • Inject 5 mL LUTALYSE Injection (equivalent to 5 mg/mL dinoprost) 1 day prior to EAZI-BREED CIDR Cattle Insert removal, on Day 6 of the 7 day administration period.
  • Observe animals for signs of estrus on Days 1 to 3 after removal of the EAZI-BREED CIDR Cattle Insert and inseminate animals about 12 hours after onset of estrus.

Lactating Dairy Cows

Indication

For use with EAZI-BREED™ CIDR® (progesterone intravaginal insert) Cattle Insert for synchronization of estrus in lactating dairy cows

Dosage

Administer one EAZI-BREED CIDR Cattle Insert per animal and remove 7 days later (for example if administered on a Monday remove the following Monday).

  • Administer 5 mL LUTALYSE Injection at the time of removal of the EAZI-BREED CIDR Cattle Insert.
  • Observe animals for signs of estrus on Days 2 to 5 after removal of the EAZI-BREED CIDR Cattle Insert and inseminate animals found in estrus following normal herd practices.
Indication

For use with FACTREL® (gonadorelin injection) Injection to synchronize estrous cycles to allow fixed-time artificial insemination (FTAI) in lactating dairy cows

Dosage

Administer 2 to 4 mL FACTREL Injection (100-200 mcg gonadorelin) per cow as an intramuscular injection in a treatment regimen with the following framework:

  • Administer the first dose of FACTREL Injection (2-4 mL) at Day 0
  • Administer LUTALYSE (25 mg dinoprost, as dinoprost tromethamine) Injection by intramuscular injection 6-8 days after the first dose of FACTREL Injection.
  • Administer a second dose of FACTREL Injection (2-4 mL) 30 to 72 hours after the LUTALYSE injection.
  • Perform FTAI 0 to 24 hours after the second dose of FACTREL Injection, or inseminate cows on detected estrus using standard herd practices.
Indication

For unobserved (silent) estrus in lactating dairy cows with a corpus luteum

Dosage

Inject a dose of 5 mL LUTALYSE Injection (25 mg dinoprost) intramuscularly. Breed cows as they are detected in estrus. If estrus has not been observed by 80 hours after injection, breed at 80 hours. If the cow returns to estrus, breed at the usual time relative to estrus.

Cattle

Indication

For treatment of pyometra (chronic endometritis) in cattle

Dosage

Inject a dose of 5 mL LUTALYSE Injection (25 mg dinoprost) intramuscularly.

Swine (sows and gilts)

Indication

For parturition induction in swine

Dosage

Inject intramuscularly within 3 days of normal predicted farrowing. The response to treatment varies by individual animals with a mean interval from administration of 2 mL LUTALYSE Injection (10 mg dinoprost) to parturition of approximately 30 hours. This can be employed to control the time of farrowing in sows and gilts in late gestation. Do not administer to sows and/or gilts prior to 3 day of normal predicted farrowing as an increased number of stillbirths and postnatal mortality may result.

Horse (mares)

Indication

For controlling the timing of estrus in estrous cycling mares.

For difficult-to-breed mares (clinically anestrous mares that have a corpus luteum).

Dosage

Administer a single intramuscular injection of 1 mg per 100 lbs (45.5 kg) body weight which is usually 1 mL to 2 mL LUTALYSE Injection. This luteolytic effect can be utilized to control the timing of estrus in estrous cycling and clinically anestrous mares that have a corpus luteum

ProstaMate®

SPL · SPL

Open original
FDA Structured Product Label

ProstaMate®

Rendered from Roxee's cached FDA SPL package contents for on-page reading. Use Open original for the raw FDA ZIP/XML source.

Sponsor
Bimeda Animal Health Ltd.
ANADA
200-253
Status
RX
Form
Injectable Solution
Route
Intramuscular
Species
Gilts • Sows • Beef cows • Beef heifers • Dairy • Dairy cows • Replacement beef and dairy heifers • Mares
Composition / specifications
5 mg dinoprost/mL as dinoprost tromethamine

Cattle (beef cows, beef heifers, and replacement dairy heifers)

Indication

For estrus synchronization in beef cows, beef heifers and replacement dairy heifers.

Dosage

ProstaMate is used to control the timing of estrus and ovulation in estrous cycling cattle that have a corpus luteum. Inject a dose of 5 mL ProstaMate (25 mg dinoprost) intramuscularly either once or twice at a 10 to 12 day interval. With the single injection, cattle should be bred at the usual time relative to estrus. With the two injections cattle can be bred after the second injection either at the usual time relative to detected estrus or at about 80 hours after the second injection of ProstaMate. Estrus is expected to occur 1 to 5 days after injection if a corpus luteum was present. Cattle that do not become pregnant to breeding at estrus on days 1 to 5 after injection will be expected to return to estrus in about 18 to 24 days.

Cattle (lactating dairy cows)

Indication

For unobserved (silent) estrus in lactating dairy cows with a corpus luteum.

Dosage

Inject a dose of 5 mL ProstaMate (25 mg dinoprost) intramuscularly. Breed cows as they are detected in estrus. If estrus has not been observed by 80 hours after injection, breed at 80 hours. If the cow returns to estrus, breed at the usual time relative to estrus. 

Indication

For use with gonadorelin injection to synchronize estrous cycles to allow fixed-time artificial insemination (FTAI) in lactating dairy cows.

Dosage

Administer 2 to 4 mL gonadorelin injection (100-200 mcg gonadorelin) per cow as an intramuscular injection in a treatment regimen with the following framework:

  • Administer the first dose of gonadorelin injection (2-4 mL) at Day 0
  • Administer ProstaMate® (25 mg dinoprost, as dinoprost tromethamine) by intramuscular injection 6-8 days after the first dose of gonadorelin injection.
  • Administer a second dose of gonadorelin injection (2-4 mL) 30 to 72 hours after the ProstaMate® injection.
  • Perform FTAI 0 to 24 hours after the second dose of gonadorelin injection, or inseminate cows on detected estrus using standard herd practices.
Indication

For use with EAZI-BREED™ CIDR® (progesterone intravaginal insert) Cattle Insert for synchronization of estrus in lactating dairy cows.

Dosage
  • Administer one EAZI-BREED™ CIDR® Cattle Insert per animal and remove 7 days later (for example if administered on a Monday remove the following Monday).
  • Administer 5 mL ProstaMate® at the time of removal of the EAZI-BREED™ CIDR® Cattle Insert.
  • Observe animals for signs of estrus on Days 2 to 5 after removal of the EAZI-BREED™ CIDR® Cattle Insert and inseminate animals found in estrus following normal herd practices.

Cattle (beef cows, dairy cows, beef heifers and replacement dairy heifers)

Indication

For treatment of pyometra (chronic endometritis) in cattle.

Dosage

Inject a dose of 5 mL ProstaMate (25 mg dinoprost) intramuscularly.

Cattle (beef cows, beef heifers and replacement dairy heifers)

Indication

For abortion in beef cows, beef heifers and replacement dairy heifers.

Dosage

ProstaMate® is indicated for its abortifacient effect in beef cows, beef heifers and replacement dairy heifers during the first 100 days of gestation. Inject a dose of 25 mg dinoprost (5 mL) intramuscularly. Cattle that abort will abort within 35 days of injection.

Cattle (beef cows, replacement beef and dairy heifers)

Indication

For use with EAZI-BREED™ CIDR® (progesterone intravaginal insert) Cattle Insert for synchronization of estrus in suckled beef cows and replacement beef and dairy heifers, advancement of first postpartum estrus in suckled beef cows, and advancement of first pubertal estrus in beef heifers.

Dosage
  • Administer one EAZI-BREED™ CIDR® Cattle Insert per animal for 7 days (for example, if administered on a Monday remove on the following Monday).
  • Inject 5 mL ProstaMate (equivalent to 5 mg/mL dinoprost) 1 day prior to EAZI-BREED™ CIDR® Cattle Insert removal, on Day 6 of the 7 day administration period.
  • Observe animals for signs of estrus on Days 1 to 3 after removal of the EAZI-BREED™ CIDR® Cattle Insert and inseminate animals about 12 hours after onset of estrus.

Swine (gilts and sows)

Indication

For parturition induction in swine.

Dosage

For intramuscular use for parturition induction in swine. ProstaMate is indicated for parturition induction in swine when injected within 3 days of normal predicted farrowing. The response to treatment varies by individual animals with a mean interval from administration of 2 mL ProstaMate (10 mg dinoprost) to parturition of approximately 30 hours. This can be employed to control the time of arrowing in sows and gilts in late gestation.

Horses (mares)

Indication

For controlling the timing of estrus in estrous cycling mares and for difficult-to-breed mares (clinically anestrous mares that have a corpus luteum).

Dosage

Administer a single intramuscular injection of 1 mg per 100 lbs (45.5 kg) body weight which is usually 1 mL to 2 mL ProstaMate.

LUTALYSE® HighCon Injection

SPL · SPL

Open original
FDA Structured Product Label

LUTALYSE® HighCon Injection

Rendered from Roxee's cached FDA SPL package contents for on-page reading. Use Open original for the raw FDA ZIP/XML source.

Sponsor
Zoetis Inc.
NADA
141-442
Status
RX
Form
Injectable Solution
Route
Intramuscular, Subcutaneous
Species
Replacement And Dairy Heifers • Beef cows • Beef heifers • Dairy
Composition / specifications
12.5 mg dinoprost/mL as dinoprost tromethamine

Cattle (Suckled Beef Cows, Replacement Beef and Dairy Heifers)

Indication

For use with EAZI-BREED CIDR (progesterone intravaginal insert) Cattle Insert for synchronization of estrus in suckled beef cows and replacement beef and dairy heifers, advancement of first postpartum estrus in suckled beef cows, and advancement of first pubertal estrus in beef heifers.

Dosage

Inject a dose of 2 mL LUTALYSE HighCon Injection (25 mg dinoprost) by intramuscular or subcutaneous injection.

Limitations

Administer one EAZI-BREED CIDR Cattle Insert per animal for 7 days (for example, if administered on a Monday remove on the following Monday). Administer a dose of 2 mL LUTALYSE HighCon Injection (25 mg dinoprost) by intramuscular or subcutaneous injection 1 day prior to EAZI-BREED CIDR Cattle Insert removal, on Day 6 of the 7 Day administration period. Observe animals for signs of estrus on Days 1 to 3 after removal of the EAZI-BREED CIDR Cattle Insert and inseminate animals about 12 hours after onset of estrus. Federal law restricts this drug to use by or on the order of a licensed veterinarian. Not for human use. Keep out of the reach of children. Women of childbearing age, asthmatics, or 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.

Cattle (Beef Cows, Beef Heifers, Replacement Dairy Heifers)

Indication

For abortion in beef cows, beef heifers and replacement dairy heifers.

Dosage

Inject a dose of 25 mg (2 mL) by intramuscular or subcutaneous injection.

Limitations

LUTALYSE HighCon Injection is indicated for its abortifacient effect in beef cows, beef heifers and replacement dairy heifers during the first 100 days of gestation. Cattle that abort will abort within 35 days of injection. Federal law restricts this drug to use by or on the order of a licensed veterinarian. Not for human use. Keep out of the reach of children. Women of childbearing age, asthmatics, or 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.

Indication

For estrus synchronization in beef cows, beef heifers and replacement dairy heifers.

Dosage

Inject a dose of 2 mL LUTALYSE HighCon Injection (25 mg dinoprost) intramuscularly or subcutaneously either once or twice at a 10 to 12 day interval.

Limitations

LUTALYSE HighCon Injection is used to control the timing of estrus and ovulation in estrous cycling cattle that have a corpus luteum. With the single injection, cattle should be bred at the usual time relative to estrus. With the two injections cattle can be bred after the second injection either at the usual time relative to detected estrus or at about 80 hours after the second injection of LUTALYSE HighCon Injection. Estrus is expected to occur 1 to 5 days after injection if a corpus luteum was present. Cattle that do not become pregnant to breeding at estrus on days 1 to 5 after injection will be expected to return to estrus in about 18 to 24 days. Federal law restricts this drug to use by or on the order of a licensed veterinarian. 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.

Cattle

Indication

For treatment of pyometra (chronic endometritis) in cattle.

Dosage

Inject a dose of 2 mL LUTALYSE HighCon Injection (25 mg dinoprost) by intramuscular or subcutaneous injection.

Limitations

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

Cattle (Lactating Dairy Cows)

Indication

For use with EAZI-BREED CIDR (progesterone intravaginal insert) Cattle Insert for synchronization of estrus in lactating dairy cows.

Dosage

Inject a dose of 2 mL LUTALYSE HighCon Injection (25 mg dinoprost) by intramuscular or subcutaneous injection.

Limitations

Administer one EAZI-BREED CIDR Cattle Insert per animal and remove 7 days later (for example, if administered on a Monday remove the following Monday). Administer a dose of 2 mL LUTALYSE HighCon Injection (25 mg dinoprost) by intramuscular or subcutaneous injection at the time of removal of the EAZI-BREED CIDR Cattle Insert. Observe animals for signs of estrus on Days 2 to 5 after removal of the EAZI-BREED CIDR Cattle Insert and inseminate animals found in estrus following normal herd practices. Federal law restricts this drug to use by or on the order of a licensed veterinarian. Not for human use. Keep out of the reach of children. Women of childbearing age, asthmatics, or 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.

Indication

For unobserved (silent) estrus in lactating dairy cows with a corpus luteum.

Dosage

Inject a dose of 2 mL LUTALYSE HighCon Injection (25 mg dinoprost) by intramuscular or subcutaneous injection.

Limitations

Breed cows as they are detected in estrus. If estrus has not been observed by 80 hours after injection, breed at 80 hours. If the cow returns to estrus, breed at the usual time relative to estrus. Federal law restricts this drug to use by or on the order of a licensed veterinarian. 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.

Indication

For use with FACTREL (gonadorelin injection) Injection to synchronize estrous cycles to allow fixed-time artificial insemination (FTAI) in lactating dairy cows.

Dosage

Inject a dose of 2 mL LUTALYSE HighCon Injection (25 mg dinoprost) by intramuscular or subcutaneous injection.

Limitations

Administer 2 to 4 mL FACTREL Injection (100-200 mcg gonadorelin) per cow as an intramuscular injection in a treatment regimen with the following framework:Administer the first dose of FACTREL Injection (2 – 4 mL) at Day 0Administer a dose of 2 mL LUTALYSE HighCon Injection (25 mg dinoprost) by intramuscular or subcutaneous injection 6 – 8 days after the first dose of FACTREL Injection.Administer a second dose of FACTREL Injection (2 – 4 mL) 30 to 72 hours after LUTALYSE HighCon InjectionPerform FTAI 0 to 24 hours after the second dose of FACTREL Injection, or inseminate cows on detected estrus using standard herd practices.Federal law restricts this drug to use by or on the order of a licensed veterinarian. Not for human use. Keep out of the reach of children. Women of childbearing age, asthmatics, or 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.

Prostin F2 Alpha® Sterile Solution

SPL · SPL

Open original
FDA Structured Product Label

Prostin F2 Alpha® Sterile Solution

Rendered from Roxee's cached FDA SPL package contents for on-page reading. Use Open original for the raw FDA ZIP/XML source.

Sponsor
Zoetis Inc.
NADA
100-202
Status
RX
Form
Liquid (Solution)
Route
Intramuscular
Species
Horse
Composition / specifications
522.690 Dinoprost tromethamine sterile solution.

Specifications:
Each milliliter of sterile solution contains the equivalent of 5 milligrams of dinoprost.

Conditions of use:

Horses (mares)

Amount:
Equivalent of 1 milligram of dinoprost per 100 pounds of body weight. For use once as a single intramuscular injection.

Indications:
For its luteolytic effect to control timing of estrus in estrus cycling mares and in clinically anestrous mares that have a corpus luteum.

Limitations:
Not for use in horses intended for food. Federal law restricts this drug to use by or on the order of a licensed veterinarian. Women of child-bearing age, asthmatics, and persons with bronchial and other respiratory problems should exercise extreme caution when handling this product. Dinoprost tromethamine is readily absorbed through the skin and can cause abortion and bronchiospasms. Accidental spillage on the skin should be washed off immediately with soap and water. Use of this

Horses (mares)

Indication
For its luteolytic effect to control timing of estrus in estrus cycling mares and in clinically anestrous mares that have a corpus luteum.
Dosage
Equivalent of 1 milligram of dinoprost per 100 pounds of body weight. For use once as a single intramuscular injection.
Limitations
Not for use in horses intended for food. Federal law restricts this drug to use by or on the order of a licensed veterinarian. Women of child-bearing age, asthmatics, and persons with bronchial and other respiratory problems should exercise extreme caution when handling this product. Dinoprost tromethamine is readily absorbed through the skin and can cause abortion and bronchiospasms. Accidental spillage on the skin should be washed off immediately with soap and water. Use of this product in excess of the approved dose may result in drug residues. Do not administer intravenously; this may potentiate adverse reactions.

Dinoprost Tromethamine SPL

SPL · Structured Product Label

Open original
FDA Structured Product Label XML for Dinoprost Tromethamine. Use the source link for the full official labeling record.

Lutalyse Sterile SPL

SPL · Structured Product Label

Open original
FDA Structured Product Label XML for Lutalyse Sterile. Use the source link for the full official labeling record.

Lutalyse HighCon Sterile SPL

SPL · Structured Product Label

Open original
FDA Structured Product Label XML for Lutalyse HighCon Sterile. Use the source link for the full official labeling record.

ProstaMate Sterile SPL

SPL · Structured Product Label

Open original
FDA Structured Product Label XML for ProstaMate Sterile. Use the source link for the full official labeling record.

UCM409077.pdf

FOI · FOI

Open original

Updated ANADA 200-253 FOI Summar.pdf

FOI · FOI

Open original

ucm061681.pdf

FOI · FOI

Open original

UCM471254.pdf

FOI · FOI

Open original

UCM461152.pdf

FOI · FOI

Open original
Source metadata:
Veterinary reference (advanced)

Canonical medication sections are above. This legacy block remains available for deeper cross-reference without cluttering the primary workflow.

At a Glance

Quick facts and links to official labeling and safety signals.

Data freshness
  • Reference facts: Source Roxee | Refreshed Jun 22, 2026, 10:45 AM UTC
    The reference fact projection used for browse cards and quick facts.
  • Animal Drugs @ FDA: Source FDA | Refreshed Jun 22, 2026, 10:41 AM UTC
    Applications/products are imported from FDA export data.
  • Animal Drugs @ FDA previews: Source FDA | Refreshed May 15, 2026, 10:00 AM UTC
    Label highlights/doc links are fetched from FDA preview endpoints.
  • Animal Drug Product Listing Directory (NDC): Source FDA | Refreshed Jun 22, 2026, 10:41 AM UTC
    Package/product NDCs from FDA’s electronic listing directory (XLS).
Official (FDA)
Identity: Generic ingredient • FDA branded products available
Official FDA brands: Dinoprost Tromethamine Lutalyse HighCon Sterile Lutalyse Sterile ProstaMate Sterile
Manufacturer mapping: Multiple FDA labelers
Catalog species: Both • FDA-labeled species: Beef cows, Beef heifers, Dairy, Dairy cows, Gilts, Horse, Mares, Replacement And Dairy Heifers, Replacement Dairy Heifers, Replacement beef and dairy heifers, Sows
Rx/OTC: RX
Form/route: Injectable Solution, Liquid (Solution) • Intramuscular, Subcutaneous
Applications: NADA 108-901 • ANADA 200-253 • NADA 141-442 • NADA 100-202
NDC: Packages 54771-1327-1 54771-1327-2 54771-1327-3 54771-1328-1 54771-1328-2 54771-1328-3 • Products 54771 61133 82231
Documents: 5 (FOI: 5) • SPL: 4 • Label highlights • Official documents
Safety (openFDA)
Top reactions: Dog 0 • Cat 0 • View
Case summaries: 0
openFDA reports are unverified and do not prove causation.
Explore
Linked using: Fda_Label (0.95), Fda_Label (0.95), Fda_Label (0.95)
Diagnosis Codes
ICD10_CM: N71.9
Inflammatory disease of uterus, unspecified

Counseling and Monitoring Highlights

Global Pet owner/Vet mode is controlled in the header. This section avoids duplicate in-page persona tabs.

Owner-facing counseling points
  • Not for use in horses intended for food. Federal law restricts this drug to use by or on the order of a licensed veterinarian. Women of child-bearing age, asthmatics, and persons with bronchial and other respiratory problems should exercise extreme caution when handling this product. Dinoprost tromethamine is readily absorbed through the skin and can cause abortion and bronchiospasms. Accidental spillage on the skin should be washed off immediately with soap and water. Use of this product in excess of the approved dose may result in drug residues. Do not administer intravenously; this may potentiate adverse reactions. Administer one EAZI-BREED CIDR Cattle Insert per animal for 7 days (for example, if administered on a Monday remove on the following Monday). Administer a dose of 2 mL LUTALYSE HighCon Injection (25 mg dinoprost) by intramuscular or subcutaneous injection 1 day prior to EAZI-BREED CIDR Cattle Insert removal, on Day 6 of the 7 Day administration period. Observe animals for signs of estrus on Days 1 to 3 after removal of the EAZI-BREED CIDR Cattle Insert and inseminate animals about 12 hours after onset of estrus. Federal law restricts this drug to use by or on the order of a licensed veterinarian. Not for human use. Keep out of the reach of children. Women of childbearing age, asthmatics, or 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. LUTALYSE HighCon Injection is indicated for its abortifacient effect in beef cows, beef heifers and replacement dairy heifers during the first 100 days of gestation. Cattle that abort will abort within 35 days of injection. Federal law restricts this drug to use by or on the order of a licensed veterinarian. Not for human use. Keep out of the reach of children. Women of childbearing age, asthmatics, or 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. (Contraindication, High)
Top reaction signals
Vomiting (1) Vaginal discharge (1) Tachypnoea (1) Itching (1) Drooling (1) Lack of efficacy - NOS (1) Constricted pupils (1)

Identifiers & Packages

Normalized identifiers (NDC/NADA/ANADA) and package metadata from regulator listings.

Identifiers
ANADA: 200253 NADA: 100202 NADA: 108901 NADA: 141442 NDC Package: 54771-1327-1 NDC Package: 54771-1327-2 NDC Package: 54771-1327-3 NDC Package: 54771-1328-1 NDC Package: 54771-1328-2 NDC Package: 54771-1328-3 NDC Package: 61133-4001-1 NDC Package: 82231-105-00 NDC Product: 54771 NDC Product: 61133 NDC Product: 82231
Package NDC Product NDC Form / Route Status
54771-1327-1 54771 -
54771-1327-2 54771 -
54771-1327-3 54771 -
54771-1328-1 54771 -
54771-1328-2 54771 -
54771-1328-3 54771 -
61133-4001-1 61133 -
82231-105-00 82231 -

Enriched Documents

Documents are tiered by source trust: Official, Clinical, Manufacturer, Marketing.

  • Dinoprost Tromethamine SPL • Structured Product Label • Official
    FDA Structured Product Label from the electronic animal drug product listing directory.
  • Lutalyse Sterile SPL • Structured Product Label • Official
    FDA Structured Product Label from the electronic animal drug product listing directory.
  • Lutalyse HighCon Sterile SPL • Structured Product Label • Official
    FDA Structured Product Label from the electronic animal drug product listing directory.
  • ProstaMate Sterile SPL • Structured Product Label • Official
    FDA Structured Product Label from the electronic animal drug product listing directory.
  • UCM409077.pdf • FOI summary • Official • May 14, 2026
    FDA FOI summary for application 108901
  • ucm061681.pdf • FOI summary • Official • Jan. 21, 2022
    FDA FOI summary for application 200253
  • Updated ANADA 200-253 FOI Summar.pdf • FOI summary • Official • Jan. 21, 2022
    FDA FOI summary for application 200253
  • UCM461152.pdf • FOI summary • Official • March 17, 2019
    FDA FOI summary for application 141442
  • UCM471254.pdf • FOI summary • Official • March 17, 2019
    FDA FOI summary for application 141442

Data Sources & Change Log

Every non-trivial field is expected to include provenance and update timestamps.

Official 69 Clinical 60 Manufacturer 0 Marketing 0
Current Field Facts
  • side_effects: Top reported reactions (openFDA): Vomiting, Drooling, Itching, Lack of efficacy - NOS, Tachypnoea, Constricted pupils. (Clinical, 2026-06-22)
  • side_effects: Top reported reactions (openFDA): Vomiting, Drooling, Itching, Lack of efficacy - NOS, Tachypnoea, Constricted pupils. (Clinical, 2026-06-22)
  • side_effects: Top reported reactions (openFDA): Vomiting, Drooling, Itching, Lack of efficacy - NOS, Tachypnoea, Constricted pupils. (Clinical, 2026-06-21)
  • side_effects: Top reported reactions (openFDA): Vomiting, Drooling, Itching, Lack of efficacy - NOS, Tachypnoea, Constricted pupils. (Clinical, 2026-06-20)
  • side_effects: Top reported reactions (openFDA): Vomiting, Drooling, Itching, Lack of efficacy - NOS, Tachypnoea, Constricted pupils. (Clinical, 2026-06-13)
  • side_effects: Top reported reactions (openFDA): Vomiting, Drooling, Itching, Lack of efficacy - NOS, Tachypnoea, Constricted pupils. (Clinical, 2026-06-12)
  • side_effects: Top reported reactions (openFDA): Vomiting, Drooling, Itching, Lack of efficacy - NOS, Tachypnoea, Constricted pupils. (Clinical, 2026-06-12)
  • side_effects: Top reported reactions (openFDA): Vomiting, Drooling, Itching, Lack of efficacy - NOS, Tachypnoea, Constricted pupils. (Clinical, 2026-06-11)
  • side_effects: Top reported reactions (openFDA): Vomiting, Drooling, Itching, Lack of efficacy - NOS, Tachypnoea, Constricted pupils. (Clinical, 2026-06-11)
  • side_effects: Top reported reactions (openFDA): Vomiting, Drooling, Itching, Lack of efficacy - NOS, Tachypnoea, Constricted pupils. (Clinical, 2026-06-10)
  • side_effects: Top reported reactions (openFDA): Vomiting, Drooling, Itching, Lack of efficacy - NOS, Tachypnoea, Constricted pupils. (Clinical, 2026-06-08)
  • side_effects: Top reported reactions (openFDA): Vomiting, Drooling, Itching, Lack of efficacy - NOS, Tachypnoea, Constricted pupils. (Clinical, 2026-06-07)
  • side_effects: Top reported reactions (openFDA): Vomiting, Drooling, Itching, Lack of efficacy - NOS, Tachypnoea, Constricted pupils. (Clinical, 2026-06-06)
  • side_effects: Top reported reactions (openFDA): Vomiting, Drooling, Itching, Lack of efficacy - NOS, Tachypnoea, Constricted pupils. (Clinical, 2026-06-05)
  • side_effects: Top reported reactions (openFDA): Vomiting, Drooling, Itching, Lack of efficacy - NOS, Tachypnoea, Constricted pupils. (Clinical, 2026-06-04)
  • side_effects: Top reported reactions (openFDA): Vomiting, Drooling, Itching, Lack of efficacy - NOS, Tachypnoea, Constricted pupils. (Clinical, 2026-06-03)
  • side_effects: Top reported reactions (openFDA): Vomiting, Drooling, Itching, Lack of efficacy - NOS, Tachypnoea, Constricted pupils. (Clinical, 2026-06-02)
  • side_effects: Top reported reactions (openFDA): Vomiting, Drooling, Itching, Lack of efficacy - NOS, Tachypnoea, Constricted pupils. (Clinical, 2026-06-01)
  • side_effects: Top reported reactions (openFDA): Vomiting, Drooling, Itching, Lack of efficacy - NOS, Tachypnoea, Constricted pupils. (Clinical, 2026-06-01)
  • side_effects: Top reported reactions (openFDA): Vomiting, Drooling, Itching, Lack of efficacy - NOS, Tachypnoea, Constricted pupils. (Clinical, 2026-05-31)
Recent Revisions
  • side_effects updated 2026-06-22 10:45 by etl_backfill • Backfilled from existing medication fields
  • contraindications updated 2026-06-22 10:45 by etl_backfill • Backfilled from existing medication fields
  • usage updated 2026-06-22 10:45 by etl_backfill • Backfilled from existing medication fields
  • side_effects updated 2026-06-22 10:04 by etl_backfill • Backfilled from existing medication fields
  • contraindications updated 2026-06-22 10:04 by etl_backfill • Backfilled from existing medication fields
  • usage updated 2026-06-22 10:04 by etl_backfill • Backfilled from existing medication fields
  • side_effects updated 2026-06-21 05:18 by etl_backfill • Backfilled from existing medication fields
  • contraindications updated 2026-06-21 05:18 by etl_backfill • Backfilled from existing medication fields
  • usage updated 2026-06-21 05:18 by etl_backfill • Backfilled from existing medication fields
  • side_effects updated 2026-06-20 20:58 by etl_backfill • Backfilled from existing medication fields
  • contraindications updated 2026-06-20 20:58 by etl_backfill • Backfilled from existing medication fields
  • usage updated 2026-06-20 20:58 by etl_backfill • Backfilled from existing medication fields
  • side_effects updated 2026-06-13 11:33 by etl_backfill • Backfilled from existing medication fields
  • contraindications updated 2026-06-13 11:33 by etl_backfill • Backfilled from existing medication fields
  • usage updated 2026-06-13 11:33 by etl_backfill • Backfilled from existing medication fields
  • side_effects updated 2026-06-12 10:42 by etl_backfill • Backfilled from existing medication fields
  • contraindications updated 2026-06-12 10:42 by etl_backfill • Backfilled from existing medication fields
  • usage updated 2026-06-12 10:42 by etl_backfill • Backfilled from existing medication fields
  • side_effects updated 2026-06-12 10:04 by etl_backfill • Backfilled from existing medication fields
  • contraindications updated 2026-06-12 10:04 by etl_backfill • Backfilled from existing medication fields

FDA Products & Applications (Animal Drugs @ FDA)

Official sponsor/proprietary-name/application-status records linked by active ingredient.

Product Sponsor Application Status Published
Lutalyse® Injection
RX
Dinoprost Tromethamine
Injectable Solution • Intramuscular
Label highlights
Official documents
Zoetis Inc. NADA 108-901 Approved May 14, 2026
ProstaMate®
RX
Dinoprost Tromethamine
Injectable Solution • Intramuscular
Label highlights
Official documents
Bimeda Animal Health Ltd. ANADA 200-253 Approved Jan 21, 2022
LUTALYSE® HighCon Injection
RX
Dinoprost Tromethamine
Injectable Solution • Intramuscular, Subcutaneous
Label highlights
Official documents
Zoetis Inc. NADA 141-442 Approved Mar 17, 2019
Prostin F2 Alpha® Sterile Solution
RX
Dinoprost Tromethamine
Liquid (Solution) • Intramuscular
Label highlights
Official documents
Zoetis Inc. NADA 100-202 Approved Jun 1, 2016

Data source: FDA Animal Drugs @ FDA (public search export).

What It's For (FDA Label Highlights)

Extracted from FDA Animal Drugs @ FDA product labeling. Always confirm details with your veterinarian.

Species: Gilts • Sows • Replacement Dairy Heifers • Beef cows • Beef heifers • Dairy • Mares
Composition / specifications
Each milliliter of sterile solution contains the equivalent of 5 milligrams of dinoprost.
Beef Cows, Beef Heifers and Replacement Dairy Heifers
Indication

For estrus synchronization in beef cows, beef heifers and replacement dairy heifers

Dosage

LUTALYSE Injection is used to control the timing of estrus and ovulation in estrous cycling cattle that have a corpus luteum. Inject a dose of 5 mL LUTALYSE Injection (25 mg dinoprost) intramuscularly either once or twice at a 10 to 12 day interval. With the single injection, cattle should be bred at the usual time relative to estrus. With the two injections cattle can be bred after the second injection either at the usual time relative to detected estrus or at about 80 hours after the second injection of LUTALYSE Injection. Estrus is expected to occur 1 to 5 days after injection if a corpus luteum was present. Cattle that do not become pregnant to breeding at estrus on days 1 to 5 after injection will be expected to return to estrus in about 18 to 24 days.

Limitations
Indication

For abortion in beef cows, beef heifers and replacement dairy heifers

Dosage

Inject a dose of 25 mg dinoprost (5 mL) intramuscularly during the first 100 days of gestation. Cattle that abort will abort within 35 days of injection.

Limitations
Label highlights
Indication

For use with EAZI-BREED™ CIDR® (progesterone intravaginal insert) Cattle Insert for synchronization of estrus in suckled beef cows and replacement beef and dairy heifers, advancement of first postpartum estrus in suckled beef cows, and advancement of first pubertal estrus in beef heifers

Dosage
  • Administer one EAZI-BREED CIDR Cattle Insert per animal for 7 days (for example, if administered on a Monday remove on the following Monday).
  • Inject 5 mL LUTALYSE Injection (equivalent to 5 mg/mL dinoprost) 1 day prior to EAZI-BREED CIDR Cattle Insert removal, on Day 6 of the 7 day administration period.
  • Observe animals for signs of estrus on Days 1 to 3 after removal of the EAZI-BREED CIDR Cattle Insert and inseminate animals about 12 hours after onset of estrus.
Limitations
Lactating Dairy Cows
Indication

For use with EAZI-BREED™ CIDR® (progesterone intravaginal insert) Cattle Insert for synchronization of estrus in lactating dairy cows

Dosage

Administer one EAZI-BREED CIDR Cattle Insert per animal and remove 7 days later (for example if administered on a Monday remove the following Monday).

  • Administer 5 mL LUTALYSE Injection at the time of removal of the EAZI-BREED CIDR Cattle Insert.
  • Observe animals for signs of estrus on Days 2 to 5 after removal of the EAZI-BREED CIDR Cattle Insert and inseminate animals found in estrus following normal herd practices.
Limitations
Indication

For use with FACTREL® (gonadorelin injection) Injection to synchronize estrous cycles to allow fixed-time artificial insemination (FTAI) in lactating dairy cows

Dosage

Administer 2 to 4 mL FACTREL Injection (100-200 mcg gonadorelin) per cow as an intramuscular injection in a treatment regimen with the following framework:

  • Administer the first dose of FACTREL Injection (2-4 mL) at Day 0
  • Administer LUTALYSE (25 mg dinoprost, as dinoprost tromethamine) Injection by intramuscular injection 6-8 days after the first dose of FACTREL Injection.
  • Administer a second dose of FACTREL Injection (2-4 mL) 30 to 72 hours after the LUTALYSE injection.
  • Perform FTAI 0 to 24 hours after the second dose of FACTREL Injection, or inseminate cows on detected estrus using standard herd practices.
Limitations
Indication

For unobserved (silent) estrus in lactating dairy cows with a corpus luteum

Dosage

Inject a dose of 5 mL LUTALYSE Injection (25 mg dinoprost) intramuscularly. Breed cows as they are detected in estrus. If estrus has not been observed by 80 hours after injection, breed at 80 hours. If the cow returns to estrus, breed at the usual time relative to estrus.

Limitations
Cattle
Indication

For treatment of pyometra (chronic endometritis) in cattle

Dosage

Inject a dose of 5 mL LUTALYSE Injection (25 mg dinoprost) intramuscularly.

Limitations
Swine (sows and gilts)
Indication

For parturition induction in swine

Dosage

Inject intramuscularly within 3 days of normal predicted farrowing. The response to treatment varies by individual animals with a mean interval from administration of 2 mL LUTALYSE Injection (10 mg dinoprost) to parturition of approximately 30 hours. This can be employed to control the time of farrowing in sows and gilts in late gestation. Do not administer to sows and/or gilts prior to 3 day of normal predicted farrowing as an increased number of stillbirths and postnatal mortality may result.

Limitations
Horse (mares)
Indication

For controlling the timing of estrus in estrous cycling mares.

For difficult-to-breed mares (clinically anestrous mares that have a corpus luteum).

Dosage

Administer a single intramuscular injection of 1 mg per 100 lbs (45.5 kg) body weight which is usually 1 mL to 2 mL LUTALYSE Injection. This luteolytic effect can be utilized to control the timing of estrus in estrous cycling and clinically anestrous mares that have a corpus luteum

Limitations

FDA page: Open in Animal Drugs @ FDA

Species: Gilts • Sows • Beef cows • Beef heifers • Dairy • Dairy cows • Replacement beef and dairy heifers • Mares
Composition / specifications
5 mg dinoprost/mL as dinoprost tromethamine
Cattle (beef cows, beef heifers, and replacement dairy heifers)
Indication

For estrus synchronization in beef cows, beef heifers and replacement dairy heifers.

Dosage

ProstaMate is used to control the timing of estrus and ovulation in estrous cycling cattle that have a corpus luteum. Inject a dose of 5 mL ProstaMate (25 mg dinoprost) intramuscularly either once or twice at a 10 to 12 day interval. With the single injection, cattle should be bred at the usual time relative to estrus. With the two injections cattle can be bred after the second injection either at the usual time relative to detected estrus or at about 80 hours after the second injection of ProstaMate. Estrus is expected to occur 1 to 5 days after injection if a corpus luteum was present. Cattle that do not become pregnant to breeding at estrus on days 1 to 5 after injection will be expected to return to estrus in about 18 to 24 days.

Limitations
Cattle (lactating dairy cows)
Indication

For unobserved (silent) estrus in lactating dairy cows with a corpus luteum.

Dosage

Inject a dose of 5 mL ProstaMate (25 mg dinoprost) intramuscularly. Breed cows as they are detected in estrus. If estrus has not been observed by 80 hours after injection, breed at 80 hours. If the cow returns to estrus, breed at the usual time relative to estrus. 

Limitations
Indication

For use with gonadorelin injection to synchronize estrous cycles to allow fixed-time artificial insemination (FTAI) in lactating dairy cows.

Dosage

Administer 2 to 4 mL gonadorelin injection (100-200 mcg gonadorelin) per cow as an intramuscular injection in a treatment regimen with the following framework:

  • Administer the first dose of gonadorelin injection (2-4 mL) at Day 0
  • Administer ProstaMate® (25 mg dinoprost, as dinoprost tromethamine) by intramuscular injection 6-8 days after the first dose of gonadorelin injection.
  • Administer a second dose of gonadorelin injection (2-4 mL) 30 to 72 hours after the ProstaMate® injection.
  • Perform FTAI 0 to 24 hours after the second dose of gonadorelin injection, or inseminate cows on detected estrus using standard herd practices.
Limitations
Indication

For use with EAZI-BREED™ CIDR® (progesterone intravaginal insert) Cattle Insert for synchronization of estrus in lactating dairy cows.

Dosage
  • Administer one EAZI-BREED™ CIDR® Cattle Insert per animal and remove 7 days later (for example if administered on a Monday remove the following Monday).
  • Administer 5 mL ProstaMate® at the time of removal of the EAZI-BREED™ CIDR® Cattle Insert.
  • Observe animals for signs of estrus on Days 2 to 5 after removal of the EAZI-BREED™ CIDR® Cattle Insert and inseminate animals found in estrus following normal herd practices.
Limitations
Cattle (beef cows, dairy cows, beef heifers and replacement dairy heifers)
Indication

For treatment of pyometra (chronic endometritis) in cattle.

Dosage

Inject a dose of 5 mL ProstaMate (25 mg dinoprost) intramuscularly.

Limitations
Cattle (beef cows, beef heifers and replacement dairy heifers)
Indication

For abortion in beef cows, beef heifers and replacement dairy heifers.

Dosage

ProstaMate® is indicated for its abortifacient effect in beef cows, beef heifers and replacement dairy heifers during the first 100 days of gestation. Inject a dose of 25 mg dinoprost (5 mL) intramuscularly. Cattle that abort will abort within 35 days of injection.

Limitations
Cattle (beef cows, replacement beef and dairy heifers)
Indication

For use with EAZI-BREED™ CIDR® (progesterone intravaginal insert) Cattle Insert for synchronization of estrus in suckled beef cows and replacement beef and dairy heifers, advancement of first postpartum estrus in suckled beef cows, and advancement of first pubertal estrus in beef heifers.

Dosage
  • Administer one EAZI-BREED™ CIDR® Cattle Insert per animal for 7 days (for example, if administered on a Monday remove on the following Monday).
  • Inject 5 mL ProstaMate (equivalent to 5 mg/mL dinoprost) 1 day prior to EAZI-BREED™ CIDR® Cattle Insert removal, on Day 6 of the 7 day administration period.
  • Observe animals for signs of estrus on Days 1 to 3 after removal of the EAZI-BREED™ CIDR® Cattle Insert and inseminate animals about 12 hours after onset of estrus.
Limitations
Swine (gilts and sows)
Indication

For parturition induction in swine.

Dosage

For intramuscular use for parturition induction in swine. ProstaMate is indicated for parturition induction in swine when injected within 3 days of normal predicted farrowing. The response to treatment varies by individual animals with a mean interval from administration of 2 mL ProstaMate (10 mg dinoprost) to parturition of approximately 30 hours. This can be employed to control the time of arrowing in sows and gilts in late gestation.

Limitations
Horses (mares)
Indication

For controlling the timing of estrus in estrous cycling mares and for difficult-to-breed mares (clinically anestrous mares that have a corpus luteum).

Dosage

Administer a single intramuscular injection of 1 mg per 100 lbs (45.5 kg) body weight which is usually 1 mL to 2 mL ProstaMate.

Limitations

FDA page: Open in Animal Drugs @ FDA

Species: Replacement And Dairy Heifers • Beef cows • Beef heifers • Dairy
Composition / specifications
12.5 mg dinoprost/mL as dinoprost tromethamine
Cattle (Suckled Beef Cows, Replacement Beef and Dairy Heifers)
Indication

For use with EAZI-BREED CIDR (progesterone intravaginal insert) Cattle Insert for synchronization of estrus in suckled beef cows and replacement beef and dairy heifers, advancement of first postpartum estrus in suckled beef cows, and advancement of first pubertal estrus in beef heifers.

Dosage

Inject a dose of 2 mL LUTALYSE HighCon Injection (25 mg dinoprost) by intramuscular or subcutaneous injection.

Limitations

Administer one EAZI-BREED CIDR Cattle Insert per animal for 7 days (for example, if administered on a Monday remove on the following Monday). Administer a dose of 2 mL LUTALYSE HighCon Injection (25 mg dinoprost) by intramuscular or subcutaneous injection 1 day prior to EAZI-BREED CIDR Cattle Insert removal, on Day 6 of the 7 Day administration period. Observe animals for signs of estrus on Days 1 to 3 after removal of the EAZI-BREED CIDR Cattle Insert and inseminate animals about 12 hours after onset of estrus. Federal law restricts this drug to use by or on the order of a licensed veterinarian. Not for human use. Keep out of the reach of children. Women of childbearing age, asthmatics, or 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.

Cattle (Beef Cows, Beef Heifers, Replacement Dairy Heifers)
Indication

For abortion in beef cows, beef heifers and replacement dairy heifers.

Dosage

Inject a dose of 25 mg (2 mL) by intramuscular or subcutaneous injection.

Limitations

LUTALYSE HighCon Injection is indicated for its abortifacient effect in beef cows, beef heifers and replacement dairy heifers during the first 100 days of gestation. Cattle that abort will abort within 35 days of injection. Federal law restricts this drug to use by or on the order of a licensed veterinarian. Not for human use. Keep out of the reach of children. Women of childbearing age, asthmatics, or 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.

Indication

For estrus synchronization in beef cows, beef heifers and replacement dairy heifers.

Dosage

Inject a dose of 2 mL LUTALYSE HighCon Injection (25 mg dinoprost) intramuscularly or subcutaneously either once or twice at a 10 to 12 day interval.

Limitations

LUTALYSE HighCon Injection is used to control the timing of estrus and ovulation in estrous cycling cattle that have a corpus luteum. With the single injection, cattle should be bred at the usual time relative to estrus. With the two injections cattle can be bred after the second injection either at the usual time relative to detected estrus or at about 80 hours after the second injection of LUTALYSE HighCon Injection. Estrus is expected to occur 1 to 5 days after injection if a corpus luteum was present. Cattle that do not become pregnant to breeding at estrus on days 1 to 5 after injection will be expected to return to estrus in about 18 to 24 days. Federal law restricts this drug to use by or on the order of a licensed veterinarian. 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.

Cattle
Indication

For treatment of pyometra (chronic endometritis) in cattle.

Dosage

Inject a dose of 2 mL LUTALYSE HighCon Injection (25 mg dinoprost) by intramuscular or subcutaneous injection.

Limitations

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

Cattle (Lactating Dairy Cows)
Indication

For use with EAZI-BREED CIDR (progesterone intravaginal insert) Cattle Insert for synchronization of estrus in lactating dairy cows.

Dosage

Inject a dose of 2 mL LUTALYSE HighCon Injection (25 mg dinoprost) by intramuscular or subcutaneous injection.

Limitations

Administer one EAZI-BREED CIDR Cattle Insert per animal and remove 7 days later (for example, if administered on a Monday remove the following Monday). Administer a dose of 2 mL LUTALYSE HighCon Injection (25 mg dinoprost) by intramuscular or subcutaneous injection at the time of removal of the EAZI-BREED CIDR Cattle Insert. Observe animals for signs of estrus on Days 2 to 5 after removal of the EAZI-BREED CIDR Cattle Insert and inseminate animals found in estrus following normal herd practices. Federal law restricts this drug to use by or on the order of a licensed veterinarian. Not for human use. Keep out of the reach of children. Women of childbearing age, asthmatics, or 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.

Indication

For unobserved (silent) estrus in lactating dairy cows with a corpus luteum.

Dosage

Inject a dose of 2 mL LUTALYSE HighCon Injection (25 mg dinoprost) by intramuscular or subcutaneous injection.

Limitations

Breed cows as they are detected in estrus. If estrus has not been observed by 80 hours after injection, breed at 80 hours. If the cow returns to estrus, breed at the usual time relative to estrus. Federal law restricts this drug to use by or on the order of a licensed veterinarian. 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.

Indication

For use with FACTREL (gonadorelin injection) Injection to synchronize estrous cycles to allow fixed-time artificial insemination (FTAI) in lactating dairy cows.

Dosage

Inject a dose of 2 mL LUTALYSE HighCon Injection (25 mg dinoprost) by intramuscular or subcutaneous injection.

Limitations

Administer 2 to 4 mL FACTREL Injection (100-200 mcg gonadorelin) per cow as an intramuscular injection in a treatment regimen with the following framework:Administer the first dose of FACTREL Injection (2 – 4 mL) at Day 0Administer a dose of 2 mL LUTALYSE HighCon Injection (25 mg dinoprost) by intramuscular or subcutaneous injection 6 – 8 days after the first dose of FACTREL Injection.Administer a second dose of FACTREL Injection (2 – 4 mL) 30 to 72 hours after LUTALYSE HighCon InjectionPerform FTAI 0 to 24 hours after the second dose of FACTREL Injection, or inseminate cows on detected estrus using standard herd practices.Federal law restricts this drug to use by or on the order of a licensed veterinarian. Not for human use. Keep out of the reach of children. Women of childbearing age, asthmatics, or 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.

FDA page: Open in Animal Drugs @ FDA

Species: Horse
Composition / specifications
522.690 Dinoprost tromethamine sterile solution.

Specifications:
Each milliliter of sterile solution contains the equivalent of 5 milligrams of dinoprost.

Conditions of use:

Horses (mares)

Amount:
Equivalent of 1 milligram of dinoprost per 100 pounds of body weight. For use once as a single intramuscular injection.

Indications:
For its luteolytic effect to control timing of estrus in estrus cycling mares and in clinically anestrous mares that have a corpus luteum.

Limitations:
Not for use in horses intended for food. Federal law restricts this drug to use by or on the order of a licensed veterinarian. Women of child-bearing age, asthmatics, and persons with bronchial and other respiratory problems should exercise extreme caution when handling this product. Dinoprost tromethamine is readily absorbed through the skin and can cause abortion and bronchiospasms. Accidental spillage on the skin should be washed off immediately with soap and water. Use of this
Horses (mares)
Indication
For its luteolytic effect to control timing of estrus in estrus cycling mares and in clinically anestrous mares that have a corpus luteum.
Dosage
Equivalent of 1 milligram of dinoprost per 100 pounds of body weight. For use once as a single intramuscular injection.
Limitations
Not for use in horses intended for food. Federal law restricts this drug to use by or on the order of a licensed veterinarian. Women of child-bearing age, asthmatics, and persons with bronchial and other respiratory problems should exercise extreme caution when handling this product. Dinoprost tromethamine is readily absorbed through the skin and can cause abortion and bronchiospasms. Accidental spillage on the skin should be washed off immediately with soap and water. Use of this product in excess of the approved dose may result in drug residues. Do not administer intravenously; this may potentiate adverse reactions.

FDA page: Open in Animal Drugs @ FDA

Usage

For its luteolytic effect to control timing of estrus in estrus cycling mares and in clinically anestrous mares that have a corpus luteum. For use with EAZI-BREED CIDR (progesterone intravaginal insert) Cattle Insert for synchronization of estrus in suckled beef cows and replacement beef and dairy heifers, advancement of first postpartum estrus in suckled beef cows, and advancement of first pubertal estrus in beef heifers. For abortion in beef cows, beef heifers and replacement dairy heifers.

Source: FDA Animal Drugs @ FDA • Reference

Contraindications

Not for use in horses intended for food. Federal law restricts this drug to use by or on the order of a licensed veterinarian. Women of child-bearing age, asthmatics, and persons with bronchial and other respiratory problems should exercise extreme caution when handling this product. Dinoprost tromethamine is readily absorbed through the skin and can cause abortion and bronchiospasms. Accidental spillage on the skin should be washed off immediately with soap and water. Use of this product in excess of the approved dose may result in drug residues. Do not administer intravenously; this may potentiate adverse reactions. Administer one EAZI-BREED CIDR Cattle Insert per animal for 7 days (for example, if administered on a Monday remove on the following Monday). Administer a dose of 2 mL LUTALYSE HighCon Injection (25 mg dinoprost) by intramuscular or subcutaneous injection 1 day prior to EAZI-BREED CIDR Cattle Insert removal, on Day 6 of the 7 Day administration period. Observe animals for signs of estrus on Days 1 to 3 after removal of the EAZI-BREED CIDR Cattle Insert and inseminate animals about 12 hours after onset of estrus. Federal law restricts this drug to use by or on the order of a licensed veterinarian. Not for human use. Keep out of the reach of children. Women of childbearing age, asthmatics, or 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. LUTALYSE HighCon Injection is indicated for its abortifacient effect in beef cows, beef heifers and replacement dairy heifers during the first 100 days of gestation. Cattle that abort will abort within 35 days of injection. Federal law restricts this drug to use by or on the order of a licensed veterinarian. Not for human use. Keep out of the reach of children. Women of childbearing age, asthmatics, or 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.

Top Reported Reactions (openFDA)

De-duplicated reaction terms grouped by body system from FDA openFDA reports (not verified; does not prove causation).

Digestive
Vomiting (1) • Dog Drooling (1) • Dog

Showing top 5 for Digestive.

Skin & allergy
Itching (1) • Dog

Showing top 5 for Skin & allergy.

Effectiveness
Lack of efficacy - NOS (1) • Dog

Showing top 5 for Effectiveness.

Other
Vaginal discharge (1) • Cat Tachypnoea (1) • Dog Constricted pupils (1) • Cat

Showing top 5 for Other.

Data source: FDA openFDA Animal & Veterinary adverse event reports.

Adverse Event Case Summaries (openFDA)

These are individual FDA adverse event reports. They are unverified and do not prove the medication caused the reaction.

No case-level openFDA reports are linked for this medication yet.

Data source: FDA openFDA Animal & Veterinary adverse event reports.

Overdose Information

No approved overdose-management text is linked yet. If overdose is suspected, contact a veterinarian or emergency clinic immediately.

Storage & Handling

No approved storage guidance is linked yet for this ingredient. Use manufacturer packaging and veterinary guidance for handling/storage.

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