ReguMate by is a Animal medication manufactured, distributed, or labeled by Merck Sharp & Dohme Corp.. Drug facts, warnings, and ingredients follow.
DESCRIPTION:
Regu-Mate® (altrenogest) Solution 0.22% contains the active synthetic progestin, altrenogest. The chemical name is 17a- allyl-17b-hydroxyestra-4,9,11-trien-3-one. The CAS Registry Number is 850-52-2. The chemical structure is:
Each mL of Regu-Mate® (altrenogest) Solution 0.22% contains 2.2 mg of altrenogest in an oil solution.
INDICATIONS:
Regu-Mate® (altrenogest) Solution 0.22% is indicated to suppress estrus in mares. Suppression of estrus allows for a predictable occurrence of estrus following drug withdrawal. This facilitates the attainment of regular cyclicity during the transition from winter anestrus to the physiological breeding season. Suppression of estrus will also facilitate management of prolonged estrus conditions. Suppression of estrus may be used to facilitate scheduled breeding during the physiological breeding season.
CONTRAINDICATIONS:
Regu-Mate® (altrenogest) Solution 0.22% is contraindicated for use in mares having a previous or current history of uterine inflammation (i.e., acute, subacute, or chronic endometritis). Natural or synthetic gestagen therapy may exacerbate existing low-grade or "smoldering" uterine inflammation into a fulminating uterine infection in some instances.
DOSAGE AND ADMINISTRATION:
While wearing protective gloves, remove shipping cap and seal; replace with enclosed plastic dispensing cap. Remove cover from bottle dispensing tip and connect luer lock syringe (without needle). Draw out appropriate volume of Regu-Mate® solution. (Note: Do not remove syringe while bottle is inverted as spillage may result.) Detach syringe and administer solution orally at the rate of 1 mL per 110 pounds body weight (0.044 mg/kg) once daily for 15 consecutive days. Administer solution directly on the base of the mare's tongue or on the mare's usual grain ration. Replace cover on bottle dispensing tip to prevent leakage. Excessive use of a syringe may cause the syringe to stick; therefore, replace syringe as necessary.
Approximate Weight In Pounds | Dose in mL |
---|---|
770 | 7 |
880 | 8 |
990 | 9 |
1100 | 10 |
1210 | 11 |
1320 | 12 |
WHICH MARES WILL RESPON D TO REGU-MATE® (altrenogest) SOLUTION 0.22%: Extensive clinical trials have demonstrated that estrus will be suppressed in approximately 95% of the mares within three days; however, the post-treatment response depended on the level of ovarian activity when treatment was initiated. Estrus in mares exhibiting regular estrus cycles during the breeding season will be suppressed during treatment; these mares return to estrus four to five days following treatment and continue to cycle normally. Mares in winter anestrus with small follicles continued in anestrus and failed to exhibit normal estrus following withdrawal.
Response in mares in the transition phase between winter anestrus and the summer breeding season depended on the degree of follicular activity. Mares with inactive ovaries and small follicles failed to respond with normal cycles post-treatment, whereas a higher proportion of mares with ovarian follicles 20 mm or greater in diameter exhibited normal estrus cycles post-treatment. Regu-Mate® (altrenogest) Solution 0.22% was very effective for suppressing the prolonged estrus behavior frequently observed in mares during the transition period (February, March and April). In addition, a high proportion of these mares responded with regular estrus cycles post-treatment.
SPECIFIC USES FOR REGU-MATE® (altrenogest) SOLUTION 0.22%:
SUPPRESSION OF ESTRUS TO:
ADDITIONAL INFORMATION:
A 3-year well controlled reproductive safety study was conducted in 27 pregnant mares, and compared with 24 untreated control mares. Treated mares received 2 mL Regu-Mate® (altrenogest) Solution 0.22% /110 lb body weight (2 × dosage recommended for estrus suppression) from day 20 to day 325 of gestation. This study provided the following data:
REFERENCES:
Shoemaker, C.F., E.L. Squires, and R.K. Shideler. 1989.
Safety of Altrenogest in Pregnant Mares and on Health and Development of Offspring. Eq. Vet. Sci. (9); No. 2: 69-72.
Squires, E.L., R.K. Shideler, and A.O. McKinnon. 1989.
Reproductive Performance of Offspring from Mares Administered Altrenogest During Gestation. Eq. Vet. Sci. (9); No. 2: 73-76.
HUMAN WARNINGS:
Skin contact must be avoided as Regu-Mate® (altrenogest) Solution 0.22% is readily absorbed through unbroken skin. Protective gloves must be worn by all persons handling this product. Pregnant women or women who suspect they are pregnant should not handle Regu-Mate® (altrenogest) Solution 0.22%. Women of child bearing age should exercise extreme caution when handling this product. Accidental absorption could lead to a disruption of the menstrual cycle or prolongation of pregnancy. Direct contact with the skin should therefore be avoided. Accidental spillage on the skin should be washed off immediately with soap and water.
INFORMATION FOR HANDLERS:
WARNING: Regu-Mate® (altrenogest) Solution 0.22% is readily absorbed by the skin. Skin contact must be avoided; protective gloves must be worn when handling this product.
Effects of Overexposure
There has been no human use of this specific product. The information contained in this section is extrapolated from data available on other products of the same pharmacological class that have been used in humans. Effects anticipated are due to the progestational activity of altrenogest.
Acute effects after a single exposure are possible; however, continued daily exposure has the potential for more untoward effects such as disruption of the menstrual cycle, uterine or abdominal cramping, increased or decreased uterine bleeding, prolongation of pregnancy and headaches. The oil base may also cause complications if swallowed.
In addition, the list of people who should not handle this product (see below) is based upon the known effects of progestins used in humans on a chronic basis.
PEOPLE WHO SHOULD NOT HANDLE THIS PRODUCT:
Accidental Exposure
Altrenogest is readily absorbed from contact with the skin. In addition, this oil based product can penetrate porous gloves. Altrenogest should not penetrate intact rubber or impervious gloves; however, if there is leakage (i.e., pinhole, spillage, etc.), the contaminated area covered by such occlusive materials may have increased absorption. The following measures are recommended in case of accidental exposure.
Skin Exposure: Wash immediately with soap and water.
Eye Exposure: Immediately flush with plenty of water for 15 minutes. Get medical attention.
If Swallowed: Do not induce vomiting. Regu-Mate® (altrenogest) Solution 0.22% contains an oil. Call a physician. Vomiting should be supervised by a physician because of possible pulmonary damage via aspiration of the oil base. If possible, bring the container and labeling to the physician.
MERCK
Animal Health
Regu-Mate®
(altrenogest)
ORAL PROGESTIN
FOR USE IN ANIMALS ONLY
1,000 mL
SOLUTION 0.22% (2.2 mg/mL)
For suppression of estrus in mares.
Suppression of estrus allows for a predictable occurrence of
estrus following drug withdrawal in mares with ovarian follicles
20 mm or greater. Suppression of estrus will facilitate:
FOR ORAL USE IN HORSES ONLY
WARNING: DO NOT USE IN HORSES INTENDED
FOR HUMAN CONSUMPTION.
CAUTION: Federal law restricts this drug to use by or on the
order of a licensed veterinarian.
Keep this and all medication out of the reach of children.
REGUMATE
altrenogest solution |
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Labeler - Merck Sharp & Dohme Corp. (001317601) |