Altrenogest Solution Recall
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Questions & Answers
Side Effects & Adverse Reactions
Keep this and all medication out of the reach of children.
User/Handler Safety: Avoid skin contact. Wear vinyl, neoprene or nitrile protective gloves when handling this product. DO NOT USE LATEX GLOVES
Pregnant women or women who suspect they are pregnant should not handle altrenogest solution 0.22%. Women of childbearing age should exercise extreme caution when handling this product. Accidental absorption could lead to a disruption of the menstrual cycle or prolongation of pregnancy. Wash off accidental spillage on the skin immediately with soap and water.
People who should not handle this product:
1. Women who are or suspect they are pregnant.
2. Anyone with thrombophlebitis or thromboembolic disorders or with a history of these events.
3. Anyone with cerebral-vascular or coronary-artery disease.
4. Women with known or suspected carcinoma of the breast.
5. People with known or suspected estrogendependent neoplasia.
6. Women with undiagnosed vaginal bleeding.
7. People with benign or malignant tumors which developed during the use of oral contraceptives or other estrogen-containing products.
8. Anyone with liver dysfunction or disease.
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 vinyl, neoprene or nitrile protective gloves; however, if there is leakage (i.e., pinhole, spillage, etc.) the contaminated area covered by such occlusive materials may have increased absorption. DO NOT USE LATEX GLOVES
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.
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.
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 is based upon the known effects of progestins used in humans on a chronic basis.
There is currently no legal information available for this drug.
FDA Safety Alerts
There are currently no FDA safety alerts available for this drug.
There is currently no manufacturer warning information available for this drug.
FDA Labeling Changes
There are currently no FDA labeling changes available for this drug.
There is currently no usage information available for this product. We apologize for any inconvenience.
There is currently no drug history available for this drug.
FOR ORAL USE IN ANIMALS ONLY
Active ingredients: Altrenogest Solution 0.22% (2.2 mg/mL)
Use: For synchronization of estrus in sexually mature gilts that have had at least one estrous cycle. Treatment with altrenogest solution 0.22% results in estrus (standing heat) 4 to 9 days after completion of the 14-day treatment period.
Caution: Federal law prohibits extra-label use of this drug to enhance food and/or fiber production in animals.
Do Not Use: In gilts having a previous or current history of uterine inflammation (i.e., acute, subacute or chronic endometritis).