Indicated for use by females of reproductive age to prevent pregnancy.

The efficacy of Minastrin 24 Fe in women with a body mass index (BMI) of more than 35 kg/m² has not been evaluated. 

Women over 35 years old who smoke should not use Minastrin 24 Fe. Cigarette smoking increases the risk of serious cardiovascular events from combination oral contraceptive (COC) use. 

Use of this product before menarche is not indicated.

Do not prescribe Minastrin 24 Fe to women who are known to have the following conditions:

• A high risk of arterial or venous thrombotic diseases. (Examples include women who are known to: smoke, if over age 35, have deep vein thrombosis or pulmonary embolism, now or in the past, have cerebrovascular disease, have coronary artery disease, have thrombogenic valvular or thrombogenic rhythm diseases of the heart (for example, subacute bacterial endocarditis with valvular disease, or atrial fibrillation), have inherited or acquired hypercoagulopathies, have uncontrolled hypertension, have diabetes mellitus with vascular disease, have headaches with focal neurological symptoms or have migraine headaches with aura, all women over age 35 with migraine headache)
• Breast cancer or other estrogen-or progestin-sensitive cancer now or in the past Liver tumors, benign or malignant, or liver disease
• Undiagnosed abnormal uterine bleeding
• Pregnancy
• Use of Hepatitis C drug combinations containing ombitasvir/paritaprevir/ritonavir, with or without dasabuvir, due to the potential for ALT elevationsStudies suggest a small increased relative risk of developing gallbladder disease among COC users. Use of COCs may also worsen existing gallbladder disease. A past history of COC-related cholestasis predicts an increased risk with subsequent COC use.

Studies have shown an increased risk of developing hepatocellular carcinoma in long-term (greater than 8 years) COC users.

Women with hypertriglyceridemia, or a family history thereof, may be at an increased risk of pancreatitis when using COCs.

If feasible, stop Minastrin 24 Fe at least 4 weeks before and through 2 weeks after major surgery or other surgeries known to have an elevated risk of VTE.

Minastrin 24 Fe may be initiated immediately after a first-trimester abortion or miscarriage; if the patient starts Minastrin 24 Fe immediately, additional contraceptive measures are not needed.

Carefully monitor prediabetic and diabetic women who are taking Minastrin 24 Fe. COCs may decrease glucose tolerance in a dose-related fashion. Consider alternative contraception for women with uncontrolled dyslipidemias.

Carefully observe women with a history of depression and discontinue Minastrin 24 Fe if depression recurs to a serious degree.

The estrogen component of COCs may raise the serum concentrations of thyroxine-binding globulin, sex hormone-binding globulin, and cortisol-binding globulin. The dose of replacement thyroid hormones or cortisol therapy may need to be increased.

In women with hereditary angioedema, exogenous estrogens may induce or exacerbate symptoms of angioedema.

Chloasma may occasionally occur, especially in women with a history of chloasma gravidarum. Women with a tendency to chloasma should avoid exposure to the sun or ultraviolet radiation while taking Minastrin 24 Fe.

Drugs or herbal products that induce certain enzymes, including cytochrome P450 3A4 (CYP3A4), may decrease the effectiveness of COCs or increase breakthrough bleeding. Some drugs or herbal products that may decrease the effectiveness of hormonal contraceptives include phenytoin, barbiturates, carbamazepine, bosentan, felbamate, griseofulvin, oxcarbazepine, rifampicin, topiramate and products containing St. John’s wort.

Ascorbic acid and acetaminophen may increase plasma ethinyl estradiol concentrations, possibly by inhibition of conjugation. CYP3A4 inhibitors such as itraconazole or ketoconazole may increase plasma hormone concentrations.

Significant changes (increase or decrease) in the plasma concentrations of the estrogen and progestin have been noted in some cases of co-administration of HIV/HCV protease inhibitors or of non-nucleoside reverse transcriptase inhibitors.

COCs have been shown to significantly decrease plasma concentrations of lamotrigine.

Administration of oral contraceptives to induce withdrawal bleeding should not be used as a test for pregnancy.

Women on thyroid hormone replacement therapy may need increased doses of thyroid hormone because serum concentration of thyroid-binding globulin increases with use of COCs.

When possible, advise the nursing mother to use other forms of contraception until she has weaned her child. COCs can reduce milk production in breastfeeding mothers. This is less likely to occur once breastfeeding is well-established; however, it can occur at any time in some women. Small amounts of oral contraceptive steroids and/or metabolites are present in breast milk.

GoToSource

• Use before before menarche. GoToSource

• Use in postmenopausal patients. GoToSource

• Use in male patients. GoToSource

• Acne. GoToSource 

• Hyperprolactinemic amenorrhea. GoToSource 

• Polycystic ovary syndrome. GoToSource 

• Prevention of rebleeding from gastrointestinal angiodysplasia. GoToSource

Venous thromboembolism, myocardial infarction and stroke. GoToSource

Glucose intolerance with marked insulin resistance. GoToSource

Exacerbation of systemic lupus erythematosus. GoToSource

Ovarian cancer. GoToSource

Breast cancer. GoToSource

Gallstone disease. GoToSource

Impaired effectiveness when taken with rifampin. GoToSource

Acute pancreatitis. GoToSource

Angioedema (swelling in deep layers of skin). GoToSource

Lawsuits filed for heart attacks, strokes, blood clots and gallbladder disease.