Microgestin 1.5/30: Black Box Warnings

Microgestin 1.5/30: Adult Dosing

Dosage forms: 30 mcg/1.5 mg

contraception

1 tab PO qd

Info: start on day 1 of menstrual cycle or on 1st Sunday after onset of menses

*dysmenorrhea

1 tab PO qd

*dysfunctional uterine bleeding

1 tab PO qd

*endometriosis

1 tab PO qd

*polycystic ovary syndrome

1 tab PO qd

renal dosing

not defined

hepatic dosing

see below

active liver dz: contraindicated

Microgestin 1.5/30: Peds Dosing

This information is currently unavailable or not applicable for this drug.

Microgestin 1.5/30: Contraindications/Cautions

• hypersens. to drug/class/compon.
• see Drug Interactions
• pregnancy
• endometrial CA
• estrogen-dependent CA
• breast CA, active or hx
• hepatic tumors, benign or malignant
• thrombophlebitis, active or hx
• thromboembolic disorders, active or hx
• surgery, major w/ prolonged immobilization
• prolonged immobilization
• smokers >35 yo/heavy smokers
• CAD
• cerebrovascular dz
• valvular heart dz w/ thrombogenesis
• thrombogenic rhythm disorders
• thrombophilias, acquired or hereditary
• HTN, uncontrolled
• diabetes mellitus w/ vascular dz
• headaches w/ neurologic sx
• bleeding, undiagnosed vaginal
• liver dz, active
• cholestatic jaundice hx, OCP or pregnancy-assoc.
• w/in 28 days post-2nd trimester abortion
• w/in 28 days postpartum
• w/in 6wk postpartum if breastfeeding
• caution if breastfeeding 6wk-6mo postpartum
• caution if impaired liver fxn
• caution if renal dz
• caution if HTN
• caution if hyperlipidemia
• caution if diabetes mellitus
• caution if sensitive to fluid retention
• caution if depression hx
• caution if vomiting or diarrhea
• caution if obesity
• caution if headaches w/o neurologic sx
• caution in nonsmokers >40 yo

Microgestin 1.5/30: Drug Interactions

Contraindicated

• amprenavir

• fosamprenavir

Avoid/Use Alternative

• aprepitant

• aromatase inhibitors

• atazanavir

• barbiturates

• bexarotene

• bosentan

• carbamazepine

• darunavir

• dexamethasone

• efavirenz

• efavirenz/emtricitabine/tenofovir

• felbamate

• griseofulvins

• growth hormone

• lopinavir/ritonavir

• modafinil

• mycophenolate mofetil

• mycophenolic acid

• nelfinavir

• nevirapine

• oxcarbazepine

• phenytoins

• pioglitazone

• pioglitazone/glimepiride

• rifabutin

• rifampins

• rifapentine

• ritonavir

• saquinavir

• tipranavir

• tizanidine

• topiramate

• ursodiol

Monitor/Modify Tx

• acitretin

• colesevelam

• cyclosporine

• dasatinib

• diazoxide

• exenatide

• hypoglycemics, other

• insulins

• lamotrigine

• metformin/pioglitazone

• metformin/rosiglitazone

• metformin/sulfonylurea combos

• rasagiline

• ropinirole

• rosiglitazone

• sitagliptin

• sulfonylureas

• tacrolimus

• theophyllines

Caution Advised

• aminocaproic acid

• aminoglycosides, oral

• ascorbic acid

• atorvastatin

• bismuth subcitrate potassium/metronidazole/tetracycline

• bismuth subsalicylate/metronidazole/tetracycline

• BZDs, 3A4 substrates

• cephalosporins

• clindamycin

• dantrolene

• fibric acid derivatives

• lansoprazole/amoxicillin/clarithromycin

• lapatinib

• macrolides

• maraviroc

• metronidazole

• nitrofurantoin

• penicillins

• quinolones, all

• ramelteon

• sulfonamides

• tacrine

• telithromycin

• temsirolimus

• tetracyclines

• tigecycline

• tinidazole

• zolmitriptan

Microgestin 1.5/30: Adverse Reactions

Serious Reactions

• thromboembolism
• thrombosis
• thrombophlebitis
• MI
• TIA
• cerebral thrombosis
• cerebral hemorrhage
• retinal thrombosis
• mesenteric thrombosis
• Budd-Chiari syndrome
• HTN
• hepatic adenoma (rare)
• cholestatic jaundice
• gallbladder dz
• pancreatitis
• colitis
• depression
• anaphylaxis/anaphylactoid rxn
• erythema multiforme
• erythema nodosum
• SLE exacerbation
• porphyria exacerbation
• chorea exacerbation
• ocular lesions

Common Reactions

• nausea/vomiting
• abdominal cramps
• bloating
• breakthrough bleeding
• altered menstrual flow
• amenorrhea
• breast tenderness
• breast changes
• edema
• headache/migraine
• weight changes
• emotional lability
• cervical secretion changes
• cervical erosion
• candidiasis, vulvovaginal
• vaginitis
• rash
• acne
• melasma/cholasma
• contact lens intolerance
• elevated BP
• glucose intolerance
• lactation decreased
• libido changes
• appetite changes
• dizziness
• hirsutism
• scalp hair loss
• varicose veins exacerbation
• folate levels decreased

Microgestin 1.5/30: Safety Monitoring

Pregnancy: X

Lactation: Safety Conditional

Monitoring Parameters: glucose if pre-diabetes/diabetes; lipid panel if hyperlipidemia; BP if HTN, HTN-related dz, or renal dz

Microgestin 1.5/30: Pharmacology

Metabolism: GI tract, liver; CYP450: 3A4 substrate/inhibitor (ethinyl estradiol)

Excretion: for ethinyl estradiol: urine 22-58%, feces 30-53%, bile 26-43%; Half-life: 26h; for norethindrone: urine 37-87% (3% unchanged), feces up to 40%; Half-life: 8h

Class: OCPs 1, monophasic

Mechanism Of Action
suppresses LH and FSH, inhibiting ovulation; alters cervical mucus and endometrium

Microgestin 1.5/30: Manufacturer/Pricing

Manufacturer: Watson Pharmaceuticals, Inc. DEA/FDA: Rx

Microgestin 1.5/30: Patient Education

• Generic Name: ethinyl estradiol and norethindrone

• Pronounced: ETH in il ess tra DYE ole and nor ETH in drone

• Brand Names: Estrostep Fe, Femcon FE, Jenest, Jenest-28, Loestrin Fe 1/20, Microgestin 1/20, Ortho-Novum, Ovcon 35, Tri-Norinyl

What is the most important information I should know about ethinyl estradiol and norethindrone?

Do not use birth control pills if you are pregnant or if you have recently had a baby.

Do not use this medication if you have any of the following conditions: a history of stroke or blood clot, circulation problems, a hormone-related cancer such as breast or uterine cancer, abnormal vaginal bleeding, liver disease or liver cancer, or a history of jaundice caused by birth control pills.

You may need to use back-up birth control, such as condoms or a spermicide, when you first start using this medication. Follow your doctor's instructions.

Taking hormones can increase your risk of blood clots, stroke, or heart attack, especially if you smoke and are older than 35.

Some drugs can make birth control pills less effective, which may result in pregnancy. Tell your doctor about all the prescription and over-the-counter medications you use, including vitamins, minerals and herbal products. Do not start using a new medication without telling your doctor.

What is ethinyl estradiol and norethindrone?

Ethinyl estradiol and norethindrone contains a combination of female hormones that prevent ovulation (the release of an egg from an ovary). This medication also causes changes in your cervical mucus and uterine lining, making it harder for sperm to reach the uterus and harder for a fertilized egg to attach to the uterus.

Ethinyl estradiol and norethindrone are used as contraception to prevent pregnancy. It is also used to treat severe acne.

Ethinyl estradiol and norethindrone may also be used for other purposes not listed in this medication guide.

What should I discuss with my healthcare provider before taking ethinyl estradiol and norethindrone?

This medication can cause birth defects. Do not use if you are pregnant. Tell your doctor right away if you become pregnant, or if you miss two menstrual periods in a row. If you have recently had a baby, wait at least 4 weeks before taking birth control pills (6 weeks if you are breast-feeding).

Do not use this medication if you have:

• a history of a stroke, blood clot, or circulation problems;
• a hormone-related cancer such as breast or uterine cancer;
• abnormal vaginal bleeding;
• liver disease, liver cancer, or a history of jaundice caused by birth control pills.

Before using this medication, tell your doctor if you have any of the following conditions.

• high blood pressure or a history of heart disease;
• high cholesterol, gallbladder disease, or diabetes;
• migraine headaches or a history of depression; or
• a history of breast cancer or an abnormal mammogram.

The hormones in birth control pills can pass into breast milk and may harm a nursing baby. This medication may also slow breast milk production. Do not use if you are breast-feeding a baby.

How should I take ethinyl estradiol and norethindrone?

Take this medication exactly as it was prescribed for you. Do not take larger amounts, or take it for longer than recommended by your doctor. You will take your first pill on the first day of your period or on the first Sunday after your period begins (follow your doctor's instructions).

You may need to use back-up birth control, such as condoms or a spermicide, when you first start using this medication. Follow your doctor's instructions.

The 28-day birth control pack contains seven "reminder" pills to keep you on your regular cycle. Your period will usually begin while you are using these reminder pills.

You may have breakthrough bleeding, especially during the first 3 months. Tell your doctor if this bleeding continues or is very heavy.

Take one pill every day, no more than 24 hours apart. When the pills run out, start a new pack the following day. You may get pregnant if you do not use this medication regularly. Get your prescription refilled before you run out of pills completely.

The chewable tablet may be chewed or swallowed whole. If chewed, drink a full glass of water just after you swallow the pill.

If you need to have any type of medical tests or surgery, or if you will be on bed rest, you may need to stop using this medication for a short time. Any doctor or surgeon who treats you should know that you are using birth control pills.

Your doctor will need to see you on a regular basis while you are using this medication. Do not miss any appointments.

Store this medication at room temperature away from moisture and heat.

What happens if I miss a dose?

Missing a pill increases your risk of becoming pregnant.

If you miss one "active" pill, take two pills on the day that you remember. Then take one pill per day for the rest of the pack.

If you miss two "active" pills in a row in week one or two, take two pills per day for two days in a row. Then take one pill per day for the rest of the pack. Use back-up birth control for at least 7 days following the missed pills.

If you miss two "active" pills in a row in week three, or if you miss three pills in a row during any of the first 3 weeks, throw out the rest of the pack and start a new one the same day if you are a Day 1 starter. If you are a Sunday starter, keep taking a pill every day until Sunday. On Sunday, throw out the rest of the pack and start a new one that day.

If you miss three "active" pills in a row during any of the first 3 weeks, throw out the rest of the pack and start a new pack on the same day if you are a Day 1 starter. If you are a Sunday starter, keep taking a pill every day until Sunday. On Sunday, throw out the rest of the pack and start a new one that day.

If you miss two or more pills, you may not have a period during the month. If you miss a period for two months in a row, call your doctor because you might be pregnant.

If you miss any reminder pills, throw them away and keep taking one pill per day until the pack is empty. You do not need back-up birth control if you miss a reminder pill.

What happens if I overdose?

Seek emergency medical attention if you think you have used too much of this medicine. Overdose symptoms may include nausea, vomiting, and vaginal bleeding.

What should I avoid while taking ethinyl estradiol and norethindrone?

Do not smoke while using birth control pills, especially if you are older than 35. Smoking can increase your risk of blood clots, stroke, or heart attack caused by birth control pills.

Birth control pills will not protect you from sexually transmitted diseases--including HIV and AIDS. Using a condom is the only way to protect yourself from these diseases.

What are the possible side effects of ethinyl estradiol and norethindrone?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Stop using this medication and call your doctor at once if you have any of these serious side effects:

• sudden numbness or weakness, especially on one side of the body;
• sudden headache, confusion, pain behind the eyes, problems with vision, speech, or balance;
• chest pain or heavy feeling, pain spreading to the arm or shoulder, nausea, sweating, general ill feeling; or
• nausea, stomach pain, low fever, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes).

Less serious side effects may include:

• mild nausea, vomiting, bloating, stomach cramps;
• breast pain, tenderness, or swelling;
• freckles or darkening of facial skin;
• increased hair growth, loss of scalp hair;
• changes in weight or appetite;
• problems with contact lenses;
• vaginal itching or discharge;
• changes in your menstrual periods, decreased sex drive; or
• headache, nervousness, dizziness.

Side effects other than those listed here may also occur. Talk to your doctor about any side effect that seems unusual or that is especially bothersome.

What other drugs will affect ethinyl estradiol and norethindrone?

Some drugs can make ethinyl estradiol and norethindrone less effective, which may result in pregnancy. Before using ethinyl estradiol and norethindrone, tell your doctor if you are using any of the following drugs:

• acetaminophen (Tylenol) or ascorbic acid (vitamin C);
• prednisolone (Orapred);
• theophylline (Respbid, Theo-Dur);
• St. John's wort;
• an antibiotic;
• seizure medication;
• a barbiturate sedative such as secobarbital (Seconal), or phenobarbital (Luminal, Solfoton); or
• HIV or AIDS medications.

There may be other drugs not listed that can affect this medication. Tell your doctor about all the prescription and over-the-counter medications you use. This includes vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start using a new medication without telling your doctor.

Where can I get more information?

Your pharmacist can provide more information about ethinyl estradiol and norethindrone.

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Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.

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The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

Microgestin 1.5/30: Pill Pictures

This information is currently unavailable or not applicable for this drug.