Normex

A synthetic progestational hormone with actions similar to those of progesterone but functioning as a more potent inhibitor of ovulation. It has weak estrogenic and androgenic properties. The hormone has been used in treating amenorrhea, functional uterine bleeding, endometriosis, and for contraception.

combined oral contraceptive, menstrual disorders

Preventing pregnancy. It may also be used for other conditions as determined by your doctor.

Normex is an estrogen/progestin combination. It works by preventing the release of eggs from the ovaries and thereby preventing pregnancy.

Female: Contraception:

Oral:

• Schedule 1 (Sunday starter): Dose begins on first Sunday after onset of menstruation; if the menstrual period starts on Sunday, take first tablet that very same day. With a Sunday start, an additional method of contraception should be used until after the first 7 days of consecutive administration:
• For 21-tablet package: 1 tablet/day for 21 consecutive days, followed by 7 days off of the medication; a new course begins on the 8th day after the last tablet is taken
• For 28-tablet package: 1 tablet/day without interruption
• Schedule 2 (Day-1 starter): Dose starts on first day of menstrual cycle taking 1 tablet/day:
• For 21-tablet package: 1 tablet/day for 21 consecutive days, followed by 7 days off of the medication; a new course begins on the 8th day after the last tablet is taken
• For 28-tablet package: 1 tablet/day without interruption

  If all doses have been taken on schedule and one menstrual period is missed, continue dosing cycle. If two consecutive menstrual periods are missed, pregnancy test is required before new dosing cycle is started.

  Missed doses monophasic formulations (refer to package insert for complete information):

• One dose missed: Take as soon as remembered or take 2 tablets next day
• Two consecutive doses missed in the first 2 weeks: Take 2 tablets as soon as remembered or 2 tablets next 2 days. An additional method of contraception should be used for 7 days after missed dose.
• Two consecutive doses missed in week 3 or three consecutive doses missed at any time: An additional method of contraception must be used for 7 days after a missed dose:
• Schedule 1 (Sunday starter): Continue dose of 1 tablet daily until Sunday, then discard the rest of the pack, and a new pack should be started that same day.
• Schedule 2 (Day-1 starter): Current pack should be discarded, and a new pack should be started that same day.

Administer at the same time each day.

How supplied

Normex (Ethinyl Estradiol (Normex) and Ethynodiol (Normex) diacetate) 1/35: Each white Normex (Ethinyl Estradiol (Normex) and Ethynodiol (Normex) diacetate) 1/35 tablet is round in shape, with a debossed SEARLE on one side and 151 and design on the other side, and contains 1 mg of Ethynodiol (Normex) diacetate and 35 mcg of Ethinyl Estradiol (Normex). (Blue placebo tablets have a debossed SEARLE on one side and a "P" on the other side.)

Normex (Ethinyl Estradiol (Normex) and Ethynodiol (Normex) diacetate) 1/50: Each white Normex (Ethinyl Estradiol (Normex) and Ethynodiol (Normex) diacetate) 1/50 tablet is round in shape, with a debossed SEARLE on one side and 71 on the other side, and contains 1 mg of Ethynodiol (Normex) diacetate and 50 mcg of Ethinyl Estradiol (Normex). (Blue placebo tablets have a debossed SEARLE on one side and a "P" on the other side.)

See also:
What is the most important information I should know about Normex?

Hypersensitivity to Ethinyl Estradiol (Normex), Ethynodiol (Normex) diacetate, or any component of the formulation; history of or current thrombophlebitis or venous thromboembolic disorders (including DVT, PE); active or recent (within 1 year) arterial thromboembolic disease (eg, stroke, MI); cerebral vascular disease, coronary artery disease, valvular heart disease with complications, severe hypertension; diabetes mellitus with vascular involvement; severe headache with focal neurological symptoms; known or suspected breast carcinoma, endometrial cancer, estrogen-dependent neoplasms, undiagnosed abnormal genital bleeding; hepatic dysfunction or tumor, cholestatic jaundice of pregnancy, jaundice with prior combination hormonal contraceptive use; major surgery with prolonged immobilization; heavy smoking ( 15 cigarettes/day) in patients >35 years of age; pregnancy.

Use Normex as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• An extra patient leaflet is available with Normex. Talk to your pharmacist if you have questions about this information.
• Take Normex by mouth with or without food.
• To achieve maximum effectiveness of Normex, it must be taken every day (every 24 hours) and at the same time each day.
• Remember to take all of the pills in the pack. Do not skip any doses.
• Be sure to have an extra full pack of this medication available at all times.
• If you miss 1 dose of Normex, take it as soon as you remember. Take your next dose at the regular time. This means you may take 2 doses on the same day. You do not need to use a backup method of birth control if you only miss 1 pill. If you miss more than 1 active dose of Normex, read the extra patient leaflet that comes with your medicine or contact your doctor for instructions. You must use a backup method of birth control if you miss more than 1 active dose of Normex. If you are not sure about how to handle missed doses, use an extra form of birth control (eg, condoms) and talk with your doctor.

Ask your health care provider any questions you may have about how to use Normex.

Ethinyl Estradiol (Normex): Substrate of CYP3A4 (major), 3A5-7 (minor); Inhibits CYP1A2 (weak), 2B6 (weak), 2C19 (weak), 3A4 (weak)

Acetaminophen: May increase plasma concentration of synthetic estrogens, possibly by inhibiting conjugation. Combination hormonal contraceptives may also decrease the plasma concentration of acetaminophen.

Acitretin: Interferes with the contraceptive effect of microdosed progestin-containing "minipill" preparations. The effect on other progestational contraceptives (eg, implants, injectables) is unknown.

Aminoglutethimide: May increase CYP metabolism of progestins leading to possible decrease in contraceptive effectiveness. Use of a nonhormonal contraceptive product is recommended.

Antibiotics (ampicillin, tetracycline): Pregnancy has been reported following concomitant use, however, pharmacokinetic studies have not shown consistent effects with these antibiotics on plasma concentrations of synthetic steroids. Use of a nonhormonal contraceptive product is recommended.

Anticoagulants: Combination hormonal contraceptives may increase or decrease the effects of coumarin derivatives. Combination hormonal contraceptives may also increase risk of thromboembolic disorders

Anticonvulsants (carbamazepine, felbamate, phenobarbital, phenytoin, topiramate): Increase the metabolism of Ethinyl Estradiol (Normex) and/or some progestins, leading to possible decrease in contraceptive effectiveness. Use of a nonhormonal contraceptive product is recommended.

Ascorbic acid: Doses of ascorbic acid (vitamin C) 1 g/day have been reported to increase plasma concentration of synthetic estrogens by ~47%, possibly by inhibiting conjugation; clinical implications are unclear.

Atorvastatin: Atorvastatin increases the AUC for norethindrone and Ethinyl Estradiol (Normex).

Benzodiazepines: Combination hormonal contraceptives may decrease the clearance of some benzodiazepines (alprazolam, chlordiazepoxide, diazepam) and increase the clearance of others (lorazepam, oxazepam, temazepam)

Clofibric acid: Combination hormonal contraceptives may increase the clearance of clofibric acid.

Cyclosporine: Combination hormonal contraceptives may inhibit the metabolism of cyclosporine, leading to increased plasma concentrations; monitor cyclosporine levels

CYP3A4 inducers: CYP3A4 inducers may decrease the levels/effects of Ethinyl Estradiol (Normex). Example inducers include aminoglutethimide, carbamazepine, nafcillin, nevirapine, phenobarbital, phenytoin, and rifamycins.

Griseofulvin: Griseofulvin may induce the metabolism of combination hormonal contraceptives causing menstrual changes; pregnancies have been reported. Use of barrier form of contraception is suggested while on griseofulvin therapy.

Morphine: Combination hormonal contraceptives may increase the clearance of morphine.

Non-nucleoside reverse transcriptase inhibitors (NNRTIs): Nevirapine may decrease plasma levels of combination hormonal contraceptives; use of a nonhormonal contraceptive product is recommended. No data for delavirdine; incomplete data for efavirenz

Prednisolone: Ethinyl Estradiol (Normex) may inhibit the metabolism of prednisolone, leading to increased plasma concentrations.

Protease inhibitors: Amprenavir, lopinavir, nelfinavir, and ritonavir have been shown to decrease plasma levels of combination hormonal contraceptives; use of a nonhormonal contraceptive product is recommended. Indinavir has been shown to increase plasma levels of combination hormonal contraceptives. No data for saquinavir.

Rifampin: Rifampin increases the metabolism of Ethinyl Estradiol (Normex) and some progestins (norethindrone) resulting in decreased contraceptive effectiveness and increased menstrual irregularities. Use of a nonhormonal contraceptive product is recommended.

Salicylic acid: Combination hormonal contraceptives may increase the clearance of salicylic acid.

Selegiline: Combination hormonal contraceptives may increase the serum concentration of selegiline.

Theophylline: Ethinyl Estradiol (Normex) may inhibit the metabolism of theophylline, leading to increased plasma concentrations.

Tricyclic antidepressants (amitriptyline, imipramine, nortriptyline): Metabolism may be inhibited by combination hormonal contraceptives, increasing plasma levels of antidepressant; use caution.

ETHANOL / NUTRITION / HERB INTERACTIONS

Food: CNS effects of caffeine may be enhanced if combination hormonal contraceptives are used concurrently with caffeine. Grapefruit juice increases Ethinyl Estradiol (Normex) concentrations and would be expected to increase progesterone serum levels as well; clinical implications are unclear.

Herb/Nutraceutical: St John's wort may decrease the effectiveness of combination hormonal contraceptives by inducing hepatic enzymes. Avoid dong quai and black cohosh (have estrogen activity). Avoid saw palmetto, red clover, ginseng.

See also:
What are the possible side effects of Normex?

Applies to Ethinyl Estradiol (Normex) / Ethynodiol (Normex): oral tablet

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

Stop using birth control pills and call your doctor at once if you have:

• signs of a stroke--sudden numbness or weakness (especially on one side of the body), sudden severe headache, slurred speech, problems with vision or balance;

• signs of a blood clot in the lung--chest pain, sudden cough, wheezing, rapid breathing, coughing up blood;

• signs of a blood clot in your leg--pain, swelling, warmth, or redness in one or both legs;

• heart attack symptoms--chest pain or pressure, pain spreading to your jaw or shoulder, nausea, sweating;

• liver problems--severe stomach pain, fever, tired feeling, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes);

• a change in the pattern or severity of migraine headaches;

• swelling in your hands, ankles, or feet;

• a breast lump; or

• symptoms of depression--sleep problems, weakness, tired feeling, mood changes.

Common side effects may include:

• light vaginal bleeding or spotting;

• problems with contact lenses;

• nausea, vomiting, bloating;

• changes in weight or appetite;

• breast tenderness or swelling;

• freckles or darkening of facial skin, increased hair growth, loss of scalp hair;

• vaginal itching or discharge;

• headache; or

• changes in your menstrual periods.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects.