Estrumate ® (cloprostenol injection)

Manufacturer
Merck Sharp & Dohme Corp. | Vet Pharma Friesoythe GmbH | Piramal Healthcare UK Limited | Cayman Pharma s.r.o.
Effective date
2017-12-15
Label type
PRESCRIPTION ANIMAL DRUG LABEL
Version
2
Source
legacy-cache
Hydrated at
2026-08-02 01:06:24

Label at a glance#

ProductEstrumate
Active ingredientcloprostenol
Label structure18 sections

Indications and uses

Cows which are not detected in estrus, although ovarian cyclicity continues, can be treated with Estrumate if a mature corpus luteum is present. Estrus is expected to occur 2 to 5 days following injection, at which time animals may be inseminated. Treated cattle should be inseminated at the usual time following detection of estrus. If estrous detection is not desirable or possible, treated animals may be inseminat...

Dosage and administration

Two mL of Estrumate (500 mcg of cloprostenol) should be administered by INTRAMUSCULAR INJECTION for all indications in both beef and dairy cattle. Do not puncture stopper more than 12 times.

Storage and handling

Protect from light. Store in container. Store at controlled room temperature 59°-86° F. (15°-30° C). USE WITHIN 28 DAYS OF FIRST USE.

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Prostaglandin Analogue for Cattle
Equivalent to 250 mcg cloprostenol/mL

DESCRIPTION SECTION

Estrumate® (cloprostenol sodium) is a synthetic prostaglandin analogue structurally related to prostaglandin F2 α (PGF2 α). Each mL of the colorless aqueous solution contains 263 mcg of cloprostenol sodium (equivalent to 250 mcg of cloprostenol) in a sodium citrate, anhydrous citric acid and sodium chloride buffer containing 0.1% w/v chlorocresol BP as a bactericide. pH is adjusted, as necessary, with sodium hydroxide or citric acid.

Chemical Structure
Chemical Structure

ACTION:

MECHANISM OF ACTION SECTION

Estrumate causes functional and morphological regression of the corpus luteum (luteolysis) in cattle. In normal, nonpregnant cycling animals, this effect on the life span of the corpus luteum usually results in estrus 2 to 5 days after treatment. In animals with prolonged luteal function (pyometra, mummified fetus, and luteal cysts), the induced luteolysis usually results in resolution of the condition and return to cyclicity. Pregnant animals may abort depending on the stage of gestation.

INDICATIONS:

INDICATIONS & USAGE SECTION

For intramuscular use to induce luteolysis in beef and dairy cattle. The luteolytic action of Estrumate can be utilized to manipulate the estrous cycle to better fit certain management practices, to terminate pregnancies resulting from mismatings, and to treat certain conditions associated with prolonged luteal function.

REQUIREMENTS FOR CONTROLLED BREEDING PROGRAMS:

SPL UNCLASSIFIED SECTION

A variety of programs can be designed to best meet the needs of individual management systems. A controlled breeding program should be selected which is appropriate for the existing circumstances and management practices.

Before a controlled breeding program is planned, the producer's objectives must be examined and he must be made aware of the projected results and limitations. The producer and his consulting veterinarian should review the operation's breeding history, herd health, and nutritional status and agree that a controlled breeding program is practical in the producer's specific situation. For any successful controlled breeding program:

  • cows and heifers must be normal, nonpregnant, and cycling (rectal palpation should be performed);
  • cattle must be in a fit and thrifty breeding condition and on an adequate or increasing plane of nutrition;
  • proper program planning and record keeping are essential;
  • if artificial insemination is used, it must be performed by competent inseminators using high-quality semen.

It is important to understand that Estrumate is effective only in animals with a mature corpus luteum (ovulation must have occurred at least 5 days prior to treatment). This must be considered when breeding is intended following a single Estrumate injection.

SAFETY AND TOXICITY:

SPL UNCLASSIFIED SECTION

At 50 and 100 times the recommended dose, mild side effects may be detected in some cattle. These include increased uneasiness, slight frothing, and milk let-down.

CONTRAINDICATIONS:

CONTRAINDICATIONS SECTION

Estrumate should not be administered to a pregnant animal whose calf is not to be aborted.

PRECAUTIONS:

PRECAUTIONS SECTION

There is no effect on fertility following the single or double dosage regimen when breeding occurs at induced estrus or at 72 and 96 hours post treatment. Conception rates may be lower than expected in those fixed time breeding programs which omit the second insemination (ie, the insemination at or near 96 hours). This is especially true if a fixed time insemination is used following a single Estrumate injection. As with all parenteral products, careful aseptic techniques should be employed to decrease the possibility of post injection bacterial infection. Antibiotic therapy should be employed at the first sign of infection.

DOSAGE AND ADMINISTRATION:

DOSAGE & ADMINISTRATION SECTION

Two mL of Estrumate (500 mcg of cloprostenol) should be administered by INTRAMUSCULAR INJECTION for all indications in both beef and dairy cattle.

Do not puncture stopper more than 12 times.

WARNINGS

WARNINGS SECTION

For veterinary use only.

SAFE HANDLING WARNING SECTION

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. Estrumate is readily absorbed through the skin and may cause abortion and/or bronchiospasms; direct contact with the skin should therefore be avoided. Accidental spillage on the skin should be washed off immediately with soap and water.

STORAGE CONDITIONS:

STORAGE AND HANDLING SECTION

  1. Protect from light.
  2. Store in container.
  3. Store at controlled room temperature 59°-86° F. (15°-30° C).
  4. USE WITHIN 28 DAYS OF FIRST USE.

HOW SUPPLIED:

HOW SUPPLIED SECTION

20mL and 100mL multidose vials

CAUTION:

SPL UNCLASSIFIED SECTION

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

SPL UNCLASSIFIED SECTION

Made in Germany.

Copyright © 2013, Intervet Inc (d/b/a Merck Animal Health) a subsidiary of Merck & Co. Madison, NJ 07940
All rights reserved. Code No. 065502 Rev. 09/16

176042 R3

PRINCIPAL DISPLAY PANEL - 20 mL Vial Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

10 Doses
20 mL

Estrumate®
(cloprostenol sodium)

Equivalent to 250 mcg cloprostenol/mL

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

MERCK
Animal Health

PRINCIPAL DISPLAY PANEL - 20 mL Vial Label
PRINCIPAL DISPLAY PANEL - 20 mL Vial Label

PRINCIPAL DISPLAY PANEL - 20 mL Vial Carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 0061-1266-02
20 mL

Estrumate®
(cloprostenol injection)

An Analogue of
Prostaglandin F2
α for
Intramuscular Injection
in Beef and Dairy Cattle.

Equivalent to 250 mcg
cloprostenol / mL

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

FOR VETERINARY USE ONLY

20 mL
10 Doses

MERCK
Animal Health

PRINCIPAL DISPLAY PANEL - 20 mL Vial Carton
PRINCIPAL DISPLAY PANEL - 20 mL Vial Carton

PRINCIPAL DISPLAY PANEL - 100 mL Vial Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

50 Doses
100 mL

Estrumate®
(cloprostenol sodium)

Equivalent to 250 mcg cloprostenol/mL

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

MERCK
Animal Health

PRINCIPAL DISPLAY PANEL - 100 mL Vial Label
PRINCIPAL DISPLAY PANEL - 100 mL Vial Label

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
cloprostenolACTIVE INGREDIENT42082388321
cloprostenolACTIVE MOIETY42082388321
anhydrous citric acidINACTIVE INGREDIENTXF417D3PSL1
chlorocresolINACTIVE INGREDIENT36W53O71091
sodium chlorideINACTIVE INGREDIENT451W47IQ8X1
trisodium citrate dihydrateINACTIVE INGREDIENTB22547B95K1
waterINACTIVE INGREDIENT059QF0KO0R1

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 7 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
0061-12660061-1266-02, 0061-1266-05

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 6 matching rows.

Source Document#

Source XML

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 5 · 244 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
sodium chlorideSODIUM CHLORIDE451W47IQ8XSOLUTION/ DROPS / TOPICAL0.86 %w/vExact identifier — unii candidate
134 equally ranked IID candidates
sodium chlorideSODIUM CHLORIDE451W47IQ8XSUPPOSITORY / RECTAL140 mgExact identifier — unii candidate
134 equally ranked IID candidates
anhydrous citric acidANHYDROUS CITRIC ACIDXF417D3PSLSUSPENSION/ DROPS / ORAL15 mgExact identifier — unii candidate
61 equally ranked IID candidates
anhydrous citric acidANHYDROUS CITRIC ACIDXF417D3PSLTABLET, ORALLY DISINTEGRATING / SUBLINGUALADJ PHExact identifier — unii candidate
61 equally ranked IID candidates
sodium chlorideSODIUM CHLORIDE451W47IQ8XJELLY / NASALNAExact identifier — unii candidate
134 equally ranked IID candidates
sodium chlorideSODIUM CHLORIDE451W47IQ8XINJECTION, SOLUTION / SUBCUTANEOUS1486 mgExact identifier — unii candidate
134 equally ranked IID candidates
trisodium citrate dihydrateTRISODIUM CITRATE DIHYDRATEB22547B95KSUSPENSION / ORAL5013 mgExact identifier — unii candidate
47 equally ranked IID candidates
sodium chlorideSODIUM CHLORIDE451W47IQ8XSUSPENSION / ORAL1126 mgExact identifier — unii candidate
134 equally ranked IID candidates
trisodium citrate dihydrateTRISODIUM CITRATE DIHYDRATEB22547B95KINJECTION / INTRAMUSCULAR3480 mgExact identifier — unii candidate
47 equally ranked IID candidates
sodium chlorideSODIUM CHLORIDE451W47IQ8XSOLUTION / IONTOPHORESIS0.6 %w/vExact identifier — unii candidate
134 equally ranked IID candidates
sodium chlorideSODIUM CHLORIDE451W47IQ8XINJECTION / INTRABURSAL9 mgExact identifier — unii candidate
134 equally ranked IID candidates
trisodium citrate dihydrateTRISODIUM CITRATE DIHYDRATEB22547B95KELIXIR / ORAL120 mgExact identifier — unii candidate
47 equally ranked IID candidates
sodium chlorideSODIUM CHLORIDE451W47IQ8XINJECTION, SOLUTION, CONCENTRATE / INTRAVENOUS0.86 %w/vExact identifier — unii candidate
134 equally ranked IID candidates
anhydrous citric acidANHYDROUS CITRIC ACIDXF417D3PSLINJECTION, SOLUTION / SUBCUTANEOUS25 mgExact identifier — unii candidate
61 equally ranked IID candidates
sodium chlorideSODIUM CHLORIDE451W47IQ8XSOLUTION / RECTALNAExact identifier — unii candidate
134 equally ranked IID candidates
anhydrous citric acidANHYDROUS CITRIC ACIDXF417D3PSLTABLET, EFFERVESCENT / ORAL840 mgExact identifier — unii candidate
61 equally ranked IID candidates
sodium chlorideSODIUM CHLORIDE451W47IQ8XINJECTION / INTRA-ARTERIAL278 mgExact identifier — unii candidate
134 equally ranked IID candidates
anhydrous citric acidANHYDROUS CITRIC ACIDXF417D3PSLINJECTION / PERINEURAL0.02 %w/vExact identifier — unii candidate
61 equally ranked IID candidates
sodium chlorideSODIUM CHLORIDE451W47IQ8XSUSPENSION / AURICULAR (OTIC)0.9 %w/vExact identifier — unii candidate
134 equally ranked IID candidates
sodium chlorideSODIUM CHLORIDE451W47IQ8XINJECTION / INTRACAUDAL210 mgExact identifier — unii candidate
134 equally ranked IID candidates
sodium chlorideSODIUM CHLORIDE451W47IQ8XINJECTION / INTRACAVITARY0.82 %w/vExact identifier — unii candidate
134 equally ranked IID candidates
sodium chlorideSODIUM CHLORIDE451W47IQ8XINJECTION, SOLUTION / SUBMUCOSAL16 %w/vExact identifier — unii candidate
134 equally ranked IID candidates
trisodium citrate dihydrateTRISODIUM CITRATE DIHYDRATEB22547B95KPOWDER / RESPIRATORY (INHALATION)17 mgExact identifier — unii candidate
47 equally ranked IID candidates
sodium chlorideSODIUM CHLORIDE451W47IQ8XSOLUTION/ DROPS / OPHTHALMIC55 mgExact identifier — unii candidate
134 equally ranked IID candidates
anhydrous citric acidANHYDROUS CITRIC ACIDXF417D3PSLTABLET, CHEWABLE, EXTENDED RELEASE / ORAL12 mgExact identifier — unii candidate
61 equally ranked IID candidates
sodium chlorideSODIUM CHLORIDE451W47IQ8XINJECTION, POWDER, FOR SOLUTION / INTRAVENOUS2922 mgExact identifier — unii candidate
134 equally ranked IID candidates
trisodium citrate dihydrateTRISODIUM CITRATE DIHYDRATEB22547B95KLOTION / TOPICAL328 mgExact identifier — unii candidate
47 equally ranked IID candidates
trisodium citrate dihydrateTRISODIUM CITRATE DIHYDRATEB22547B95KSOLUTION / RESPIRATORY (INHALATION)24 mgExact identifier — unii candidate
47 equally ranked IID candidates
sodium chlorideSODIUM CHLORIDE451W47IQ8XINJECTION, SUSPENSION / INTRA-ARTICULAR26 mgExact identifier — unii candidate
134 equally ranked IID candidates
anhydrous citric acidANHYDROUS CITRIC ACIDXF417D3PSLFILM, SOLUBLE / BUCCAL2 mgExact identifier — unii candidate
61 equally ranked IID candidates
trisodium citrate dihydrateTRISODIUM CITRATE DIHYDRATEB22547B95KSOLUTION / RECTAL773 mgExact identifier — unii candidate
47 equally ranked IID candidates
sodium chlorideSODIUM CHLORIDE451W47IQ8XPOWDER / RESPIRATORY (INHALATION)NAExact identifier — unii candidate
134 equally ranked IID candidates
sodium chlorideSODIUM CHLORIDE451W47IQ8XTABLET, COATED / ORAL54.7 mgExact identifier — unii candidate
134 equally ranked IID candidates
sodium chlorideSODIUM CHLORIDE451W47IQ8XGRANULE, FOR SUSPENSION / ORAL162 mgExact identifier — unii candidate
134 equally ranked IID candidates
sodium chlorideSODIUM CHLORIDE451W47IQ8XINJECTION, POWDER, FOR SOLUTION / INTRAMUSCULAR226 mgExact identifier — unii candidate
134 equally ranked IID candidates
anhydrous citric acidANHYDROUS CITRIC ACIDXF417D3PSLSPRAY / NASAL5 mgExact identifier — unii candidate
61 equally ranked IID candidates
sodium chlorideSODIUM CHLORIDE451W47IQ8XINJECTION, POWDER, FOR SOLUTION / INTRA-ARTERIAL1.35 mgExact identifier — unii candidate
134 equally ranked IID candidates
sodium chlorideSODIUM CHLORIDE451W47IQ8XINJECTION, SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR24 mgExact identifier — unii candidate
134 equally ranked IID candidates
sodium chlorideSODIUM CHLORIDE451W47IQ8XCAPSULE / ORAL6 mgExact identifier — unii candidate
134 equally ranked IID candidates
sodium chlorideSODIUM CHLORIDE451W47IQ8XINJECTION, SOLUTION / SUBARACHNOID0.9 %w/vExact identifier — unii candidate
134 equally ranked IID candidates
anhydrous citric acidANHYDROUS CITRIC ACIDXF417D3PSLINJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / INTRAVENOUS414 mgExact identifier — unii candidate
61 equally ranked IID candidates
sodium chlorideSODIUM CHLORIDE451W47IQ8XINJECTION, SOLUTION, CONCENTRATE / INTRAMUSCULAR0.86 %w/vExact identifier — unii candidate
134 equally ranked IID candidates
anhydrous citric acidANHYDROUS CITRIC ACIDXF417D3PSLSUSPENSION / RESPIRATORY (INHALATION)1 mgExact identifier — unii candidate
61 equally ranked IID candidates
trisodium citrate dihydrateTRISODIUM CITRATE DIHYDRATEB22547B95KINJECTION, SOLUTION, CONCENTRATE / INTRAOCULAR22 mgExact identifier — unii candidate
47 equally ranked IID candidates
sodium chlorideSODIUM CHLORIDE451W47IQ8XINJECTION, SUSPENSION, LIPOSOMAL / EPIDURAL11 mgExact identifier — unii candidate
134 equally ranked IID candidates
sodium chlorideSODIUM CHLORIDE451W47IQ8XSUSPENSION / TOPICAL0.32 %w/vExact identifier — unii candidate
134 equally ranked IID candidates
trisodium citrate dihydrateTRISODIUM CITRATE DIHYDRATEB22547B95KSHAMPOO / TOPICAL186 mgExact identifier — unii candidate
47 equally ranked IID candidates
sodium chlorideSODIUM CHLORIDE451W47IQ8XINJECTION / RETROBULBAR648 mgExact identifier — unii candidate
134 equally ranked IID candidates
sodium chlorideSODIUM CHLORIDE451W47IQ8XDROPS / NASALNAExact identifier — unii candidate
134 equally ranked IID candidates
sodium chlorideSODIUM CHLORIDE451W47IQ8XSUSPENSION / SUBCUTANEOUS0.8 %w/vExact identifier — unii candidate
134 equally ranked IID candidates
sodium chlorideSODIUM CHLORIDE451W47IQ8XLIQUID / INTRAMUSCULAR17 mgExact identifier — unii candidate
134 equally ranked IID candidates
sodium chlorideSODIUM CHLORIDE451W47IQ8XINJECTION, POWDER, FOR SOLUTION / INTRAPERITONEAL226 mgExact identifier — unii candidate
134 equally ranked IID candidates
trisodium citrate dihydrateTRISODIUM CITRATE DIHYDRATEB22547B95KINJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / INTRACAVERNOUS0.03 mgExact identifier — unii candidate
47 equally ranked IID candidates
sodium chlorideSODIUM CHLORIDE451W47IQ8XGEL / OPHTHALMIC0.9 %w/vExact identifier — unii candidate
134 equally ranked IID candidates
trisodium citrate dihydrateTRISODIUM CITRATE DIHYDRATEB22547B95KSOLUTION / ORAL1200 mgExact identifier — unii candidate
47 equally ranked IID candidates
trisodium citrate dihydrateTRISODIUM CITRATE DIHYDRATEB22547B95KINJECTION / SUBCUTANEOUS75 mgExact identifier — unii candidate
47 equally ranked IID candidates
sodium chlorideSODIUM CHLORIDE451W47IQ8XSOLUTION / TOPICAL210 mgExact identifier — unii candidate
134 equally ranked IID candidates
trisodium citrate dihydrateTRISODIUM CITRATE DIHYDRATEB22547B95KSOLUTION / OPHTHALMIC0.45 %w/vExact identifier — unii candidate
47 equally ranked IID candidates
sodium chlorideSODIUM CHLORIDE451W47IQ8XTABLET, EXTENDED RELEASE / ORAL335.1 mgExact identifier — unii candidate
134 equally ranked IID candidates
trisodium citrate dihydrateTRISODIUM CITRATE DIHYDRATEB22547B95KINJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / INTRAVENOUS800 mgExact identifier — unii candidate
47 equally ranked IID candidates

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.