Microgestin 1.5/30

Norethindrone Acetate/Ethinyl Estradiol · Kit

Prescription (Rx)

Boxed warning. Cigarette smoking increases the risk of serious cardiovascular side effects from oral contraceptive use. This risk increases with age and with heavy smoking (15 or more cigarettes per day) and is quite marked in women over 35 years of age. Women who use oral contraceptives should be strongly advised not to smoke.

Uses

Microgestin 1.5/30 is indicated for the prevention of pregnancy in women who elect to use oral contraceptives as a method of contraception. Oral contraceptives are highly effective. Table 1 lists the typical accidental pregnancy rates for users of combination oral contraceptives and other methods of contraception. The efficacy of these contraceptive methods, except sterilization, depends upon the reliability with which they are used. Correct and consistent use of methods can result in lower failure rates. 2

Dosage and administration

The compact tablet dispenser has been designed to make oral contraceptive dosing as easy and as convenient as possible. The tablets are arranged in three rows of seven tablets each, with the days of the week appearing on the compact tablet dispenser above the first row of tablets. Note: Each compact tablet dispenser has been preprinted with the days of the week, starting with Sunday, to facilitate a Sunday-Start regimen. Six different day label stickers have been provided with the Detailed Patient & Brief Summary Patient Package Insert in order to accommodate a Day-1 Start regimen. If the patient is using the Day-1 Start regimen, she should place the self-adhesive day label sticker that corresponds to her starting day over the preprinted days. Important: The patient should be instructed to use an additional method of protection until after the first week of administration in the initial cycle when utilizing the Sunday-Start regimen. The possibility of ovulation and conception prior to initiation of use should be considered. Dosage and Administration for 21-Day Dosage Regimen To achieve maximum contraceptive effectiveness, Microgestin 1.5/30 should be taken exactly as directed and at intervals not exceeding 24 hours. Microgestin 1.5/30 provides the patient with a convenient tablet schedule of "3 weeks on-1 week off". Two dosage regimens are described, one of which may be more convenient or suitable than the other for an individual patient. For the initial cycle of therapy, the patient begins her tablets according to the Day 1 Start or Sunday-Start regimen. With either regimen, the patient takes one tablet daily for 21 consecutive days followed by one week of no tablets. A. Sunday-Start Regimen: The patient begins taking tablets from the top row of the dispenser (labeled Sunday) on the first Sunday after menstrual flow begins. When the menstrual flow begins on Sunday, the first tablet is taken on the same day. The last tablet in the dispenser will be taken on a Saturday, followed by no tablets for a week (7 days). For all subsequent cycles, the patient then begins a new 21-tablet regimen on the eighth day, Sunday, after taking her last tablet. Following this regimen, of 21 days on-7 days off, the patient will start all subsequent cycles on a Sunday. B. Day-1 Start Regimen: The first day of menstrual flow is Day 1. The patient places the self-adhesive day label sticker that corresponds to her starting day over the preprinted days on the tablet dispenser. She starts taking one tablet daily, beginning with the first tablet in the top row. The patient completes her 21-tablet regimen when she has taken the last tablet in the tablet dispenser. She will then take no tablets for a week (7 days). For all subsequent cycles, the patient begins a new 21-tablet regimen on the eighth day after taking her last tablet, again starting with the first tablet in the top row after placing the appropriate day label sticker over the preprinted days on the tablet dispenser. Following this regimen of 21 days on--7 days off, the patient will start all subsequent cycles on the same day of the week as the first course. Likewise, the interval of no tablets will always start on the same day of the week. Tablets should be taken regularly with a meal or at bedtime. It should be stressed that efficacy of medication depends on strict adherence to the dosage schedule. Special Notes on Administration Menstruation usually begins two or three days, but may begin as late as the fourth or fifth day, after discontinuing medication. If spotting occurs while on the usual regimen of one tablet daily, the patient should continue medication without interruption. If the patient forgets to take one or more tablets, the following is suggested: One tablet is missed ● take tablet as soon as remembered ● take next tablet at the regular time Two consecutive tablets are missed (week 1 or week 2) ● take two tablets as soon as remembered ● take two tablets the next day ● use another birth control method for seven days following the missed tablets Two consecutive tablets are missed (week 3) Sunday-Start Regimen: ● take one tablet daily until Sunday ● discard remaining tablets ● start new pack of tablets immediately (Sunday) ● use another birth control method for seven days following the missed tablets Day-1 Start Regimen: ● discard remaining tablets ● start new pack of tablets that same day ● use another birth control method for seven days following the missed tablets Three (or more) consecutive tablets are missed Sunday-Start Regimen: ● take one tablet daily until Sunday ● discard remaining tablets ● start new pack of tablets immediately (Sunday) ● use another birth control method for seven days following the missed tablets Day-1 Start Regimen: ● discard remaining tablets ● start new pack of tablets that same day ● use another birth control method for seven days following the missed tablets The possibility of ovulation occurring increases with each successive day that scheduled yellow tablets are missed. While there is little likelihood of ovulation occurring if only one yellow tablet is missed, the possibility of spotting or bleeding is increased. This is particularly likely to occur if two or more consecutive yellow tablets are missed. In the rare case of bleeding which resembles menstruation, the patient should be advised to discontinue medication and then begin taking tablets from a new compact tablet dispenser on the next Sunday or the first day (Day-1), depending on her regimen. Persistent bleeding which is not controlled by this method indicates the need for reexamination of the patient, at which time nonfunctional causes should be considered. Use of Oral Contraceptives in the Event of a Missed Menstrual Period 1. If the patient has not adhered to the prescribed dosage regimen, the possibility of pregnancy should be considered after the first missed period and oral contraceptives should be withheld until pregnancy has been ruled out. 2.

Contraindications

Oral contraceptives should not be used in women who currently have the following conditions: ● Thrombophlebitis or thromboembolic disorders ● A past history of deep vein thrombophlebitis or thromboembolic disorders ● Cerebral vascular or coronary artery disease ● Known or suspected carcinoma of the breast ● Carcinoma of the endometrium or other known or suspected estrogen-dependent neoplasia ● Undiagnosed abnormal genital bleeding ● Cholestatic jaundice of pregnancy or jaundice with prior pill use ● Hepatic adenomas or carcinomas ● Known or suspected pregnancy ● Are receiving Hepatitis C drug combinations containing ombitasvir/paritaprevir/ritonavir, with or without dasabuvir, due to the potential for ALT elevations (see Warnings , RISK OF LIVER ENZYME ELEVATIONS WITH CONCOMITANT HEPATITIS C TREATMENT ).

Warnings

The use of oral contraceptives is associated with increased risks of several serious conditions including myocardial infarction, thromboembolism, stroke, hepatic neoplasia, and gallbladder disease, although the risk of serious morbidity or mortality is very small in healthy women without underlying risk factors. The risk of morbidity and mortality increases significantly in the presence of other underlying risk factors such as hypertension, hyperlipidemias, obesity, and diabetes. Practitioners prescribing oral contraceptives should be familiar with the following information relating to these risks. The information contained in this package insert is principally based on studies carried out in patients who used oral contraceptives with higher formulations of estrogens and progestogens than those in common use today. The effect of long-term use of the oral contraceptives with lower formulations of both estrogens and progestogens remains to be determined. Throughout this labeling, epidemiological studies reported are of two types: retrospective or case control studies and prospective or cohort studies. Case control studies provide a measure of the relative risk of a disease, namely, a ratio of the incidence of a disease among oral contraceptive users to that among nonusers. The relative risk does not provide information on the actual clinical occurrence of a disease. Cohort studies provide a measure of attributable risk, which is the difference in the incidence of disease between oral contraceptive users and nonusers. The attributable risk does provide information about the actual occurrence of a disease in the population (adapted from References 8 and 9 with the author's permission). For further information, the reader is referred to a text on epidemiological methods. 1. Thromboembolic Disorders and Other Vascular Problems a. Myocardial Infarction An increased risk of myocardial infarction has been attributed to oral contraceptive use. This risk is primarily in smokers or women with other underlying risk factors for coronary artery disease such as hypertension, hypercholesterolemia, morbid obesity, and diabetes. The relative risk of heart attack for current oral contraceptive users has been estimated to be two to six (10 to 16) . The risk is very low under the age of 30. Smoking in combination with oral contraceptive use has been shown to contribute substantially to the incidence of myocardial infarctions in women in their mid-thirties or older with smoking accounting for the majority of excess cases (17) . Mortality rates associated with circulatory disease have been shown to increase substantially in smokers over the age of 35 and non-smokers over the age of 40 (Table II) among women who use oral contraceptives. Oral contraceptives may compound the effects of well-known risk factors, such as hypertension, diabetes, hyperlipidemias, age and obesity (19) . In particular, some progestogens are known to decrease HDL cholesterol and cause glucose intolerance, while estrogens may create a state of hyperinsulinism (20 to 24) . Oral contraceptives have been shown to increase blood pressure among users (see section 10 in WARNINGS ). Similar effects on risk factors have been associated with an increased risk of heart disease. Oral contraceptives must be used with caution in women with cardiovascular disease risk factors. b. Thromboembolism An increased risk of thromboembolic and thrombotic disease associated with the use of oral contraceptives is well established. Case control studies have found the relative risk of users compared to non-users to be 3 for the first episode of superficial venous thrombosis, 4 to 11 for deep vein thrombosis or pulmonary embolism, and 1.5 to 6 for women with predisposing conditions for venous thromboembolic disease (9,10,25 to 30) . Cohort studies have shown the relative risk to be somewhat lower, about 3 for new cases and about 4.5 for new cases requiring hospitalization (31) . The risk of thromboembolic disease due to oral contraceptives is not related to length of use and disappears after pill use is stopped (8) . A two- to four-fold increase in relative risk of postoperative thromboembolic complications has been reported with the use of oral contraceptives (15,32) . The relative risk of venous thrombosis in women who have predisposing conditions is twice that of women without such medical conditions (15,32) . If feasible, oral contraceptives should be discontinued at least four weeks prior to and for two weeks after elective surgery of a type associated with an increase in risk of thromboembolism and during and following prolonged immobilization. Since the immediate postpartum period is also associated with an increased risk of thromboembolism, oral contraceptives should be started no earlier than four to six weeks after delivery in women who elect not to breastfeed. c. Cerebrovascular Diseases Oral contraceptives have been shown to increase both the relative and attributable risks of cerebrovascular events (thrombotic and hemorrhagic strokes), although, in general, the risk is greatest among older (> 35 years), hypertensive women who also smoke. Hypertension was found to be a risk factor for both users and nonusers, for both types of strokes, while smoking interacted to increase the risk for hemorrhagic strokes (33 to 35) . In a large study, the relative risk of thrombotic strokes has been shown to range from 3 for normotensive users to 14 for users with severe hypertension (36) . The relative risk of hemorrhagic stroke is reported to be 1.2 for non-smokers who used oral contraceptives, 2.6 for smokers who did not use oral contraceptives, 7.6 for smokers who used oral contraceptives, 1.8 for normotensive users, and 25.7 for users with severe hypertension (36) . The attributable risk is also greater in older women (9) . d.

Precautions

1. Patients should be counseled that this product does not protect against HIV infection (AIDS) and other sexually transmitted diseases. 2. Physical Examination and Follow-Up It is good medical practice for all women to have annual history and physical examinations, including women using oral contraceptives. The physical examination, however, may be deferred until after initiation of oral contraceptives if requested by the woman and judged appropriate by the clinician. The physical examination should include special reference to blood pressure, breasts, abdomen and pelvic organs, including cervical cytology, and relevant laboratory tests. In case of undiagnosed, persistent or recurrent abnormal vaginal bleeding, appropriate measures should be conducted to rule out malignancy. Women with a strong family history of breast cancer or who have breast nodules should be monitored with particular care. 3. Lipid Disorders Women who are being treated for hyperlipidemia should be followed closely if they elect to use oral contraceptives. Some progestogens may elevate LDL levels and may render the control of hyperlipidemias more difficult. 4. Liver Function If jaundice develops in any woman receiving such drugs, the medication should be discontinued. Steroid hormones may be poorly metabolized in patients with impaired liver function. 5. Fluid Retention Oral contraceptives may cause some degree of fluid retention. They should be prescribed with caution, and only with careful monitoring, in patients with conditions which might be aggravated by fluid retention. 6. Emotional Disorders Women with a history of depression should be carefully observed and the drug discontinued if depression recurs to a serious degree. 7. Contact Lenses Contact lens wearers who develop visual changes or changes in lens tolerance should be assessed by an ophthalmologist. 8. Drug Interactions Effects of Other Drugs on Oral Contraceptives (78) Rifampin: Metabolism of both norethindrone and ethinyl estradiol is increased by rifampin. A reduction in contraceptive effectiveness and increased incidence of breakthrough bleeding and menstrual irregularities have been associated with concomitant use of rifampin. Anticonvulsants: Anticonvulsants such as phenobarbital, phenytoin, and carbamazepine, have been shown to increase the metabolism of ethinyl estradiol and/or norethindrone, which could result in a reduction in contraceptive effectiveness. Troglitazone: Administration of troglitazone with an oral contraceptive containing ethinyl estradiol and norethindrone reduced the plasma concentrations of both by approximately 30%, which could result in a reduction of contraceptive effectiveness. Antibiotics: Pregnancy while taking oral contraceptives has been reported when the oral contraceptives were administered with antimicrobials such as ampicillin, tetracycline, and griseofulvin. However, clinical pharmacokinetic studies have not demonstrated any consistent effect of antibiotics (other than rifampin) on plasma concentrations of synthetic steroids. Atorvastatin: Coadministration of atorvastatin and an oral contraceptive increased AUC values for norethindrone and ethinyl estradiol by approximately 30% and 20%, respectively. Concomitant Use with HCV Combination Therapy – Liver Enzyme Elevation Do not co-administer [DRUG] with HCV drug combinations containing ombitasvir/paritaprevir/ritonavir, with or without dasabuvir, due to potential for ALT elevations (see Warnings , RISK OF LIVER ENZYME ELEVATIONS WITHCONCOMITANT HEPATITIS C TREATMENT ) Others: Ascorbic acid and acetaminophen may increase plasma ethinyl estradiol concentrations, possibly by inhibition of conjugation. A reduction in contraceptive effectiveness and increased incidence of breakthrough bleeding has been suggested with phenylbutazone. Effects of Oral Contraceptives on Other Drugs Oral contraceptive combinations containing ethinyl estradiol may inhibit the metabolism of other compounds. Increased plasma concentrations of cyclosporine, prednisolone, and theophylline have been reported with concomitant administration of oral contraceptives. In addition, oral contraceptives may induce the conjugation of other compounds. Decreased plasma concentrations of acetaminophen and increased clearance of temazepam, salicylic acid, morphine, and clofibric acid have been noted when these drugs were administered with oral contraceptives. 9. Interactions with Laboratory Tests Certain endocrine and liver function tests and blood components may be affected by oral contraceptives: a. Increased prothrombin and factors VII, VIII, IX, and X; decreased antithrombin 3; increased norepinephrine-induced platelet aggregability. b. Increased thyroid binding globulin (TBG) leading to increased circulating total thyroid hormone, as measured by protein-bound iodine (PBI), T 4 by column or by radioimmunoassay. Free T3 resin uptake is decreased, reflecting the elevated TBG; free T 4 concentration is unaltered. c. Other binding proteins may be elevated in serum. d. Sex-binding globulins are increased and result in elevated levels of total circulating sex steroids and corticoids; however, free or biologically active levels remain unchanged. e. Triglycerides may be increased. f. Glucose tolerance may be decreased. g. Serum folate levels may be depressed by oral contraceptive therapy. This may be of clinical significance if a woman becomes pregnant shortly after discontinuing oral contraceptives. 10. Carcinogenesis See WARNINGS section. 11. Pregnancy Pregnancy Category X. See CONTRAINDICATIONS and WARNINGS sections. 12. Nursing Mothers Small amounts of oral contraceptive steroids have been identified in the milk of nursing mothers, and a few adverse effects on the child have been reported, including jaundice and breast enlargement. In addition, oral contraceptives given in the postpartum period may interfere with lactation by decreasing the quantity and quality of breast milk.

Side effects

An increased risk of the following serious adverse reactions has been associated with the use of oral contraceptives (see WARNINGS section): ● Thrombophlebitis ● Arterial thromboembolism ● Pulmonary embolism ● Myocardial infarction ● Cerebral hemorrhage ● Cerebral thrombosis ● Hypertension ● Gallbladder disease ● Hepatic adenomas or benign liver tumors There is evidence of an association between the following conditions and the use of oral contraceptives, although additional confirmatory studies are needed: ● Mesenteric thrombosis ● Retinal thrombosis The following adverse reactions have been reported in patients receiving oral contraceptives and are believed to be drug-related: ● Nausea ● Vomiting ● Gastrointestinal symptoms (such as abdominal cramps and bloating) ● Breakthrough bleeding ● Spotting ● Change in menstrual flow ● Amenorrhea ● Temporary infertility after discontinuation of treatment ● Edema ● Melasma which may persist ● Breast changes: tenderness, enlargement, secretion ● Change in weight (increase or decrease) ● Change in cervical erosion and secretion ● Diminution in lactation when given immediately postpartum ● Cholestatic jaundice ● Rash (allergic) ● Mental depression ● Reduced tolerance to carbohydrates ● Vaginal candidiasis ● Change in corneal curvature (steepening) ● Intolerance to contact lenses The following adverse reactions have been reported in users of oral contraceptives and the association has been neither confirmed nor refuted: ● Pre-menstrual syndrome ● Cataracts ● Changes in appetite ● Cystitis-like syndrome ● Headache ● Nervousness ● Dizziness ● Hirsutism ● Loss of scalp hair ● Erythema multiforme ● Erythema nodosum ● Hemorrhagic eruption ● Vaginitis ● Porphyria ● Impaired renal function ● Hemolytic uremic syndrome ● Budd-Chiari syndrome ● Acne ● Changes in libido ● Colitis

Overdosage

Serious ill effects have not been reported following acute ingestion of large doses of oral contraceptives by young children. Overdosage may cause nausea, and withdrawal bleeding may occur in females. NON-CONTRACEPTIVE HEALTH BENEFITS The following non-contraceptive health benefits related to the use of oral contraceptives are supported by epidemiological studies which largely utilized oral contraceptive formulations containing estrogen doses exceeding 0.035 mg of ethinyl estradiol or 0.05 mg of mestranol (79 to 84) . Effects on menses: ● Increased menstrual cycle regularity ● Decreased blood loss and decreased incidence of iron deficiency anemia ● Decreased incidence of dysmenorrhea Effects related to inhibition of ovulation: ● Decreased incidence of functional ovarian cysts ● Decreased incidence of ectopic pregnancies Effects from long-term use: ● Decreased incidence of fibroadenomas and fibrocystic disease of the breast ● Decreased incidence of acute pelvic inflammatory disease ● Decreased incidence of endometrial cancer ● Decreased incidence of ovarian cancer

Description

Microgestin 1.5/30 is a progestogen-estrogen combination. Microgestin 1.5/30 provides a continuous dosage regimen consisting of 21 yellow oral contraceptive tablets. Each yellow tablet contains norethindrone acetate (17 alpha-ethinyl-19-nortestosterone acetate), 1.5 mg; ethinyl estradiol (17 alpha-ethinyl-1,3,5(10)-estratriene-3, 17 beta-diol), 30mcg. Also contains polyvinyl alcohol, titanium dioxide, talc, macrogol/polyethylglycol 3350 NF, lecithin (soya), iron oxide yellow, FD&C Blue No.2 Aluminum Lake, D&C Yellow No.10 Aluminum Lake, FD&C Yellow No.6 Aluminum Lake, lactose, magnesium stearate and pregelatinized corn starch. The structural formulas are as follows: 1

How supplied

Microgestin 1.5/30 is available in dispensers (NDC 51862-872-01) each containing 21 yellow tablets. Each yellow, biconvex, round tablet debossed with "L3" on one side contains 1.5mg of norethindrone acetate and 30 mcg of ethinyl estradiol. Microgestin 1.5/30 Tablets are available in the following configurations: Carton of 1 NDC 51862-872-02 Carton of 3 NDC 51862-872-03 Carton of 6 NDC 51862-872-06 Store at 20 ˚C ~ 25 ˚C (68 ˚F~77 ˚F) [See USP Controlled Room Temperature].

Patient information

See patient labeling printed below.

Label text from the FDA structured product label by Mayne Pharma Inc. (revised Jul 9, 2025). Long sections are shortened; the complete label is on DailyMed.

Microgestin 1.5/30 NDC products (2)

NDC	Strength & form	Labeler	Type
75907-083	Kit	Dr. Reddys Laboratories Inc.	ANDA
51862-872	Kit	Mayne Pharma Inc.	ANDA

Frequently asked questions

What is Microgestin 1.5/30 used for?

What are the side effects of Microgestin 1.5/30?

Who makes Microgestin 1.5/30?

Microgestin 1.5/30 is listed by 2 labelers in the FDA NDC directory, including Dr. Reddys Laboratories Inc., Mayne Pharma Inc..