The reference site for Norgestimate

Norgestimate (INN, USAN, BAN) (brand names Ortho-Cyclen, Ortho Tri-Cyclen, Previfem, Sprintec, Prefest, others) is a steroidal progestin of the 19-nortestosterone group that is used in combination with ethinylestradiol as an oral contraceptive and in combination with estradiol in menopausal hormone replacement therapy.

WHAT IS Norgestimate?

Norgestimate is a molecule used in hormonal contraceptives. It is usually used in combination with estradiol, and sold under the trade name Ortho-Prefest®.

Estradiol is a female sex hormone that is involved in the development and maintenance of the female reproductive system. On the other hand, norgestimate is a form of progesterone, which is a female hormone important for the regulation of ovulation and menstruation.

When combined, these two drugs are used to treat the symptoms of menopause such as feelings of warmth in the face, neck and chest, or sudden intense spells of heat and sweating (hot flushes), to treat vulvar and vaginal changes (itching, burning, dryness in or around the vagina, difficulty or burning with urination) caused by menopause, and to prevent thinning of the bones (osteoporosis).

 

Brand Name(s): Ortho-Prefest (combination with estradiol)
CAS nº: 35189-28-7
(nor JESS tih mate)

 

Product Info

The sections below will provide you with more specific information and guidelines related to norgestimate and its correct use. Please read them carefully.

FDA Information

Ethinyl estradiol and norgestimate-containing contraceptives were first approved by the FDA in 1989. This OC containing norgestimate, was then approved by the FDA in December 1996 for the treatment of moderate acne vulgaris in females who have no known contraindications to oral contraceptive therapy and are unresponsive to topical anti-acne medications.

Following this, the FDA Approved Ortho-Prefest® (estradiol and norgestimate) for menopause symptoms in 1999.

Please visit the official site of the FDA for further information.

Why is this medication prescribed?

Norgestimate is a molecule used in hormonal contraceptives. It is usually used in combination with estradiol and sold under the trade name Ortho-Prefest®.

Ortho-Prefest® tablets are a mixture of a estrogen female hormone and a progestin. Estradiol is essential for maintaining normal female functions and is normally produced by the ovaries. After menopause, for example, the ovaries decrease their production of this hormone. Estradiol can help relieve symptoms of the menopause (hot flashes, night sweats, mood changes, and vaginal dryness and irritation), and may also help to prevent the onset of osteoporosis (a loss of bone mass, so that bones become brittle and easily broken).

Additionally, norgestimate is a progestin that is helpful in reducing overgrowth of the lining of the uterus (the endometrium), which may help reduce your risk of endometrial cancer.

Other uses for this medicine

This medication can also help regulate menstrual flow, treat acne, or may be used for other hormone related problems in females.

However, it is important that you talk to your doctor about the possible risks of using this drug for your particular condition.

Dosage and using this medicine

This medication comes as a tablet that is to be taken orally, preferably with a full glass of water.

Take estradiol and norgestimate exactly as directed by your doctor. If you do not understand these directions, ask your pharmacist, nurse, or doctor to explain them to you.

Treatment with the Ortho-Prefest® brand of estradiol and norgestimate consists of taking one pink colored tablet (1 mg estradiol) once a day for three days, followed by taking one white colored tablet (1 mg estradiol and 0.09 mg norgestimate) once a day for three days. This cycle is repeated continuously during treatment. Start with the first tablet in the first row of a package, and place the corresponding weekday schedule sticker in the appropriate space. After all of the tablets from one blister card have been used, take the first tablet from a new blister card on the following day.

Try to take estradiol and norgestimate at the same time each day.

Have yearly physical exams and examine your breasts for lumps on a monthly basis while taking estradiol and norgestimate.

What special precautions should I follow?

BEFORE TAKING ESTRADIOL AND NORGESTIMATE:

Tell your doctor if you have high blood pressure, angina, heart disease, high levels of cholesterol or triglycerides in your blood, liver disease, kidney disease, asthma, epilepsy, migraines, depression, diabetes, gallbladder disease, uterine fibroids, or if you have had a hysterectomy (uterus removed).

Moreover, please inform your doctor if you are taking any of the following medicines: insulin or an oral diabetes medicine such as glipizide (Glucotrol®), glyburide (Diabeta®, Micronase®, Glynase®),chlorpropamide (Diabinese®), tolazamide (Tolinase®), tolbutamide (Orinase®), and others; or an anticoagulant (blood thinner) such as warfarin (Coumadin®). You may not be able to take estradiol and norgestimate or you may require a dosage adjustment or special monitoring during your treatment if you are taking any of the medicines listed above.

Drugs other than those listed here may also interact with estradiol and norgestimate. Talk to your doctor and pharmacist before taking any prescription or over-the-counter medicines.

Do not take estradiol and norgestimate without first talking to your doctor if you have a circulation, bleeding, or blood-clotting disorder, undiagnosed, abnormal vaginal bleeding, any type of breast, uterine, or hormone-dependent cancer. Taking estradiol and norgestimate may be dangerous in some cases if you have any of the conditions listed above.

Estradiol and norgestimate is in the FDA pregnancy category X. This means that the medication will cause birth defects in an unborn baby. Do not take estradiol and norgestimate if you are pregnant or if you are planning a pregnancy.

Additionally, estradiol and norgestimate may affect milk flow and milk composition. Do not take estradiol and norgestimate without first talking to your doctor if you are breast-feeding a baby.

There are no restrictions on food, beverages, or activity while taking estradiol and norgestimate unless your doctor directs otherwise.

What should I do if I forget a dose?

Take the missed dose as soon as you remember. Do not take a double dose of this medication unless otherwise directed by your doctor. If a dose is missed for one or more days, take the next tablet in order. Continue to take only one tablet each day in sequence.

What side effects can this medication cause?

Stop taking estradiol and norgestimate and seek emergency medical attention or call your doctor immediately if you experience any of the following serious side effects:

an allergic reaction (difficulty breathing, closing of your throat, swelling of your lips, tongue, or face, or hives)
shortness or breath or pain in your chest
a painful, red, swollen leg
abnormal vaginal bleeding
pain, swelling, or tenderness in the abdomen
severe headache, dizziness, faintness or changes in vision or speech
vomiting
yellowing of the skin or eyes
a lump in a breast

Other, less serious side effects may be more likely to occur.
Continue to take estradiol and norgestimate and talk to your doctor if you experience:

nausea
tenderness or enlargement of the breasts
swelling of your hands or feet
spotty darkening of the skin, particularly on the face
changes in your menstrual cycle, such as irregular bleeding or spotting
headache, migraine, dizziness, faintness, or change in vision including intolerance to contact lenses
depression
vaginal yeast infections
enlargement of uterine fibroids

Estradiol increases the risk of developing endometrial hyperplasia, a condition that may lead to cancer of the lining of the uterus. Taking a progestin, such as norgestimate, with estradiol lowers the risk of developing this condition. Visit your doctor regularly and report any unusual vaginal bleeding right away.

It is unclear to what extent estrogen and progesterone treatments affect the risk of breast cancer.

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 storage conditions are needed for this medicine?

Always keep this medication in the container it came in, tightly closed, and out of reach of children. Store it at room temperature and away from excess heat and moisture (not in the bathroom).

Please remember to throw away any medication that is outdated or no longer needed. Should it be necessary, talk to your pharmacist about the proper disposal of your medication.

In case of an emergency/overdose

In the case of an overdose, call your local poison control center on 1-800-222-1222. However, if the victim has collapsed or is not breathing, please call the local emergency services immediately on 911.

Symptoms of overdose may include:

nausea
vomiting
vaginal bleeding

Product Images

PICTURES OF NORGESTIMATE PILLS

Below you will find images and specific information on the principal types of norgestimate that exist, including their respective brand name(s), strength, inscription codes, manufacturers and/or distributors.

The information below includes general information and guidelines for patients taking this medication and should never be used to substitute professional medical advice that can be provided by a qualified physician or family doctor.

Name: ORTHO-PREFEST®
Strength(s): 1 mg estradiol / 0.09 mg norgestimate
Imprint: ORTHO-PREFEST
Manufacturer: DURAMED / BARR LABS.

Contact us