What is Minastrin 24 Fe (Norethindrone Acetate and Ethinyl Estradiol/Ferrous Fumarate Capsules)? What Is It Used For?

What is Minastrin 24 Fe?

Minastrin 24 Fe is a birth control pill. It contains two female hormones, an estrogen called ethinyl estradiol and a progestin called norethindrone acetate. The chances of getting pregnant depend on how well the instructions for taking birth control pills are followed. The better the instructions are followed, the less chance of getting pregnant.

What Are the Possible Side Effects of Minastrin 24 Fe?

Serious adverse reactions associated with the use of COCs include:

  • serious cardiovascular events and stroke
  • liver disease
  • irregular uterine bleeding
  • nausea
  • breast tenderness
  • headache
  • nausea, vomiting
  • gaining weight
  • hypersensitivity reaction
  • skin and subcutaneous disorders
  • myalgia
  • eye disorders
  • depression, insomnia, anxiety, libido changes
  • kidney and urinary tract disorders

WARNING

Cigarette smoking increases the risk of serious cardiovascular events from combination oral contraceptive (COC) use. This risk increases with age, especially in women over 35 and the number of cigarettes smoked. Therefore, COCs should not be used by women over the age of 35 who smoke.

What are the indications?

Minastrin 24 Fe is indicated for use by women of reproductive age to prevent pregnancy.

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

What are the dosage and usage recommendations?

To achieve maximum contraceptive effectiveness, Minastrin 24 Fe should be taken exactly as directed. Patients should be instructed to take one capsule by mouth at the same time each day. Capsules should be taken in the order indicated on the blister pack. Capsules should not be skipped or taken at intervals exceeding 24 hours. Minastrin 24 Fe can be administered independently of meals. The patient should be instructed to start taking Minastrin 24 Fe on the first day of the menstrual cycle (Start of Day 1) or on the first Sunday after the start of the menstrual period (Start of Sunday).

What are the Storage Conditions?

Minastrin should be stored at 25°C (77°F); can be found outside at 15 to 30 °C (59 to 86 °F). It should be stored away from light and out of reach of children. The blister card should be stored in the wallet provided in the carton when not in use.

Warnings and Precautions

Thromboembolic Disorders and Other Vascular Problems: Minastrin 24 Fe should be discontinued if an arterial or deep venous thrombotic event (VTE) occurs. Minastrin 24 Fe should be discontinued if there is unexplained vision loss, proptosis, diplopia, papilledema, or retinal vascular lesions. Retinal vein thrombosis should be evaluated immediately. If possible, Minastrin 24 Fe should be stopped at least 4 weeks before and 2 weeks after major surgery or other surgeries known to be at high risk of VTE. In non-breastfeeding women, Minastrin 24 Fe should be started no later than 4 weeks after delivery. While the risk of postpartum VTE decreases after the third week postpartum, the risk of ovulation increases after the third week postpartum. COC use increases the risk of VTE. However, pregnancy increases the risk of VTE more than use of COCs. The risk of VTE in women using COCs is 3 to 9 per 10,000 woman-years. The risk of VTE is highest in the first year of COC use. The risk of thromboembolic disease associated with oral contraceptives gradually disappears after COC use is discontinued. COCs should be used with caution in women with cardiovascular disease risk factors.

Liver Disease: Minastrin 24 Fe should not be used in women with acute viral hepatitis or severe (decompensated) liver cirrhosis. Acute or chronic disorders of liver function may require discontinuation of COC use until liver function markers return to normal and the COC cause is eliminated. If jaundice develops, Minastrin 24 Fe should be discontinued.

Liver Tumors: Minastrin 24 Fe is contraindicated in women with benign and malignant liver tumors. Liver adenomas are associated with COC use. Rupture of liver adenomas can cause death through intra-abdominal bleeding. However, the attributable risk of liver cancer in COC users is less than one per million users.

Hypertension: Minastrin 24 Fe is contraindicated in women with uncontrolled hypertension or hypertension with vascular disease. For women with well-controlled hypertension, blood pressure should be monitored and Minastrin 24 Fe should be stopped if blood pressure rises significantly.

Gallbladder Discomfort: Studies show a small increased risk of developing gallbladder disease among COC users. COC use may also worsen existing gallbladder disease. Past history of COC-related cholestasis predicts an increased risk with subsequent COC use. Women with a history of pregnancy-related cholestasis may be at increased risk for COC-related cholestasis.

Carbohydrate and Lipid Metabolic Effects: Prediabetic and diabetic women using Minastrin 24 Fe should be carefully monitored. COCs can decrease glucose tolerance in a dose-dependent manner. Alternative contraception should be considered for women with uncontrollable dyslipidemias. A small proportion of women will have adverse lipid changes while using POPs. Women with hypertriglyceridemia or a family history of it may be at increased risk of pancreatitis using COCs.

Headache: If a woman taking Minastrin 24 Fe develops new headaches that are recurrent, persistent, or severe, the cause should be evaluated and Minastrin 24 Fe should be discontinued if indicated. If migraine frequency or severity increases during COC use, discontinuation of Minastrin 24 Fe should be considered.

Bleeding Irregularities and Amenorrhea: Unplanned bleeding and spotting sometimes occur in patients using COCs, especially during the first three months of use. If bleeding continues or occurs after previous regular cycles, causes such as pregnancy or malignancy should be checked. Women who are not pregnant and taking Minastrin 24 Fe may experience amenorrhea. If there has been no planned bleeding, the possibility of pregnancy should be considered. If the patient has not adhered to the prescribed dosing schedule (missed one or more active capsules or started taking it one day later than expected), the possibility of pregnancy should be considered during the first missed period and appropriate diagnostic measures should be taken. If the patient adheres to the prescribed regimen and misses two consecutive periods, pregnancy should be ruled out.

COC Use Before or During Early Pregnancy: Extensive epidemiological studies have revealed no increased risk of birth defects in women who used oral contraceptives before pregnancy. Studies do not suggest a teratogenic effect, especially when it comes to cardiac anomalies and limb reduction defects, especially when oral contraceptives are accidentally taken in early pregnancy. If pregnancy is confirmed, Minastrin 24 Fe should be discontinued. Administration of oral contraceptives to induce withdrawal bleeding should not be used as a pregnancy test.

Depression: Women with a history of depression should be carefully observed and Minastrin 24 Fe should be discontinued if the depression recurs to a severe degree.

Breast and Cervical Carcinoma: Minastrin 24 Fe is contraindicated in women who currently have or have had breast cancer because breast cancer may be hormonally sensitive. There is substantial evidence that COCs do not increase the incidence of breast cancer. Although some past studies have suggested that COCs may increase the incidence of breast cancer, more recent studies have not confirmed such findings.

Tracing: A woman taking COCs should make an annual visit with her healthcare provider for blood pressure control and other health care specified.

Chloasma: Chloasma can sometimes 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.

Pregnancy: Women who unintentionally use COCs in early pregnancy have little or no risk of birth defects. Epidemiological studies and meta-analyses have found no increased risk of genital or non-genital birth defects (including heart anomalies and limb reduction defects) following exposure to low-dose COCs before conception or during early pregnancy. COC administration should not be used as a pregnancy test to induce withdrawal bleeding. COCs should not be used to treat threatened or habitual abortion during pregnancy.

Breastfeeding Period: If possible, the nursing mother should be advised to use other methods of contraception until she is weaned. COCs can reduce milk production in nursing mothers. This is less likely once breastfeeding is well established; however, it can occur at any time in some women. Small amounts of oral contraceptive steroids and/or their metabolites are found in breast milk.

Pediatric Use: The safety and efficacy of Minastrin 24 Fe have been established in women of reproductive age. Efficacy in postpubertal adolescents under 18 years of age is expected to be the same as in users 18 years and older. This product is not indicated for use before menarche.

Geriatric Use: Minastrin 24 Fe has not been studied in postmenopausal women and is not indicated in this population.

What should be done in case of overdose?

There have been no reports of serious side effects from overdose of oral contraceptives, including ingestion by children. Overdose may cause withdrawal bleeding and nausea in women.

What are the contraindications?

Minastrin 24 Fe should not be prescribed to women known to have the following conditions:

  • High risk of arterial or venous thrombotic disease
  • Known or present deep vein thrombosis or pulmonary embolism
  • Cerebrovascular and coronary artery diseases
  • Thrombogenic valve or thrombogenic rhythm diseases in the heart
  • Hereditary or acquired hypercoagulopathies
  • uncontrolled hypertension
  • Vascular disease with diabetes mellitus
  • Headache and migraine with focal neurological symptoms
  • All women over 35 with migraine headaches
  • Benign or liver tumors, liver disease
  • Undiagnosed abnormal uterine bleeding
  • Pregnancy
  • Known present or past breast cancer or other estrogen/progestin sensitive cancer

Movement Mechanism

COCs primarily reduce the risk of conception by suppressing ovulation. Other possible mechanisms may include cervical mucus changes that inhibit sperm penetration and endometrial changes that reduce the likelihood of implantation.

Norethindrone acetate appears to be completely and rapidly deacetylated to norethindrone after oral administration, since the distribution of norethindrone acetate is indistinguishable from that of orally administered norethindrone. Norethindrone acetate and ethinyl estradiol are rapidly absorbed from norethindrone acetate / ethinyl estradiol tablets; Maximum plasma concentrations of norethindrone and ethinyl estradiol occur 1 to 4 hours after dosing. Both are subject to first pass metabolism after oral dosing, resulting in an absolute bioavailability of approximately 64% for norethindrone and approximately 43% for ethinyl estradiol. Steady state for norethindrone was reached on Day 17 and for ethinyl estradiol on Day 13. Minastrin 24 Fe can be administered regardless of meals.

Norethindrone undergoes extensive biotransformation, primarily through reduction and subsequent sulfate and glucuronide conjugation. Most circulating metabolites are sulfates, and glucuronides make up most of the urinary metabolites. Norethindrone and ethinyl estradiol are excreted in both urine and faeces, mainly as metabolites. Plasma clearance values ​​for norethindrone and ethinyl estradiol are similar (approximately 0.4 L/hr/kg). Steady-state elimination half-lives of norethindrone and ethinyl estradiol following administration of norethindrone acetate/ethinyl estradiol tablets are approximately 8 hours and 14 hours, respectively.

Necessary Information for Safe and Effective Use

The healthcare professional may prescribe Minastrin 24 Fe for the patient only. It should not be used for purposes other than prescribed and should not be given to others, even if they have the same symptoms. Minastrin 24 Fe should be kept out of the reach of children.

Source: Minastrin 24 Fe (Norethindrone Acetate and Ethinyl Estradiol/Ferrous Fumarate Capsules) Drug, 2013

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