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Caution: Federal law prohibits dispensing without prescription.
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WARNING: THE USE OF Aygestin DURING THE FIRST FOUR MONTHS OF PREGNANCY IS NOT RECOMMENDED. Progestational agents have been used beginning with the first trimester of pregnancy in an attempt to prevent habitual abortion. There is no adequate evidence that such use is effective when such drugs are given during the first four months of pregnancy. Furthermore, in the vast majority of women, the cause of abortion is a defective ovum which progestational agents could not be expected to influence. In addition, the use of progestational agents, with their uterine-relaxant properties, in patients with fertilized defective ova may cause a delay in spontaneous abortion. Therefore, the use of such drugs during the first four months of pregnancy is not recommended. Several reports suggest an association between intrauterine exposure to progestational drugs in the first trimester of pregnancy and genital abnormalities in male and female fetuses. The risk of hypospadias, 5 to 8 per 1,000 male births in the general population, may be approximately doubled with exposure to these drugs. There are insufficient data to quantify the risk to exposed female fetuses, but insofar as some of these drugs induce mild virilization of the external genitalia of the female fetus, and because of the increased association of hypospadias in the male fetus, it is prudent to avoid the use of these drugs during the first trimester of pregnancy. If the patient is exposed to Aygestin (norethindrone acetate tablets, USP) during the first four months of pregnancy or if she becomes pregnant while taking this drug, she should be apprised of the potential risks to the fetus. |
Aygestin (norethindrone acetate tablets, USP)--5 mg oral tablets.
Aygestin, (17-hydroxy-19-nor-17(alpha)-pregn-4-en-20-yn-3-one acetate), a synthetic, orally active progestin, is the acetic acid ester of norethindrone. It is a white, or creamy white, crystalline powder.
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Aygestin Tablets contain the following inactive ingredients: lactose, magnesium stearate, and microcrystalline cellulose.
Norethindrone acetate induces secretory changes in an estrogen-primed endometrium. It acts to inhibit the secretion of pituitary gonadotropins which, in turn, prevent follicular maturation and ovulation. On a weight basis, it is twice as potent as norethindrone.
Aygestin is indicated for the treatment of secondary amenorrhea, endometriosis, and abnormal uterine bleeding due to hormonal imbalance in the absence of organic pathology, such as submucous fibroids or uterine cancer.
Thrombophlebitis, thromboembolic disorders, cerebral apoplexy, or a past history of these conditions.
Markedly impaired liver function or liver disease.
Known or suspected carcinoma of the breast.
Missed abortion.
As a diagnostic test for pregnancy.
GENERAL PRECAUTIONS.
INFORMATION FOR THE PATIENT.
See text which appears at the end of this insert.
CARCINOGENESIS, MUTAGENESIS, AND IMPAIRMENT OF FERTILITY.
Some beagle dogs treated with medroxyprogesterone acetate developed mammary nodules. Although nodules occasionally appeared in control animals, they were intermittent in nature, whereas nodules in treated animals were larger and more numerous, and persisted. There is no general agreement as to whether the nodules are benign or malignant. Their significance with respect to humans has not been established.
PREGNANCY CATEGORY X.
See Boxed Warning .
NURSING MOTHERS.
Detectable amounts of progestogens have been identified in the milk of mothers receiving them. The effect of this on the nursing infant has not been determined.
PEDIATRIC USE.
Safety and effectiveness in pediatric patients have not been established.
The following adverse reactions have been observed in women taking progestins:
Spotting.
Amenorrhea.
Changes in weight (decreases, increases).
Changes in cervical erosion and cervical secretions.
Rash (allergic) with and without pruritus.
Progestins may alter the result of pregnanediol determinations. The following laboratory results may be altered by the concomitant use of estrogens with progestins:
Coagulation tests--increase in prothrombin, factors VII, VIII, IX, and X.
Increase in PBI, BEI, and a decrease in T 3 uptake
Reduced response to metyrapone test.
A statistically significant association has been demonstrated between use of estrogen-progestogen combination drugs and the following serious adverse reactions: thrombophlebitis, pulmonary embolism, and cerebral thrombosis and embolism. For this reason, patients on progestogen therapy should be carefully observed. Although available evidence is suggestive of an association, such a relationship has been neither confirmed nor refuted for the following serious adverse reactions:
Neuro-ocular lesions, e.g., retinal thrombosis and optic neuritis.
The following adverse reactions have been observed in patients receiving estrogen-progestogen combination drugs:
In view of these observations, patients on progestogen therapy should be carefully observed.
Therapy with Aygestin must be adapted to the specific indications and therapeutic response of the individual patient. This dosage schedule assumes the interval between menses to be 28 days.
Secondary amenorrhea, abnormal uterine bleeding due to hormonal imbalance in the absence of organic pathology: 2.5 to 10 mg Aygestin may be given daily for 5 to 10 days during the second half of the theoretical menstrual cycle to produce an optimum secretory transformation of an endometrium that has been adequately primed with either endogenous or exogenous estrogen.
Progestin withdrawal bleeding usually occurs within three to seven days after discontinuing Aygestin therapy. Patients with a past history of recurrent episodes of abnormal uterine bleeding may benefit from planned menstrual cycling with Aygestin.
Endometriosis: Initial daily dosage of 5 mg Aygestin for two weeks. Dosage should be increased by 2.5 mg per day every two weeks until 15 mg per day of Aygestin is reached. Therapy may be held at this level for six to nine months or until annoying breakthrough bleeding demands temporary termination.
Each white, scored Aygestin® Tablet contains 5 mg norethindrone acetate, USP, in bottles of 50 (NDC 59911-5894-1).
Dispense in a well-closed container as defined in the USP
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Your doctor has prescribed Aygestin (norethindrone acetate tablets, USP), a progestin, for you. Aygestin is similar to the progesterone hormones naturally produced by the body. Progestins are used to treat menstrual disorders and to test if the body is producing certain hormones.
Progesterone or progesterone-like drugs have been used to prevent miscarriage in the first few months of pregnancy. No adequate evidence is available to show that they are effective for this purpose. Furthermore, most cases of early miscarriage are due to causes which could not be helped by these drugs.
There is an increased risk of minor birth defects in children whose mothers take this drug during the first four months of pregnancy. Several reports suggest an association between mothers who take these drugs in the first trimester of pregnancy and genital abnormalities in male and female babies. The risk to the male baby is the possibility of being born with a condition in which the opening of the penis is on the underside rather than the tip of the penis (hypospadias). Hypospadias occurs in about 5 to 8 per 1,000 male births and is about doubled with exposure to these drugs. There is not enough information to quantify the risk to exposed female fetuses, but enlargement of the clitoris and fusion of the labia may occur, although rarely.
Therefore, since drugs of this type may induce mild masculinization of the external genitalia of the female fetus, as well as hypospadias in the male fetus, it is wise to avoid using the drug during the first trimester of pregnancy.
These drugs have been used as a test for pregnancy but such use is no longer considered safe because of possible damage to a developing baby. Also, more rapid methods for testing for pregnancy are now available.
If you take Aygestin (norethindrone acetate tablets, USP) and later find you were pregnant when you took it, be sure to discuss this with your doctor as soon as possible.
Aygestin® (norethindrone acetate tablets, USP)--white, scored 5 mg tablets, in bottles of 50, for oral administration.
ESI Lederle Inc.
Philadelphia, PA 19101
CI 4835-1 Revised March 6, 1996