CombiPatch

DRUG DESCRIPTION

CombiPatch ® (estradiol/norethindrone acetate transdermal system) is an adhesive-based matrix transdermal patch designed to release both estradiol and norethindrone acetate (NETA), a progestational agent, continuously upon application to intact skin.

Two systems are available, providing the following delivery rates of estradiol and norethindrone acetate.

System Size
Estradiol (mg)
NETA1 (mg)
Nominal Delivery Rate2 (mg per day) Estradiol / NETA
9 sq cm round
0.62
2.7
0.05 / 0.14
16 sq cm round
0.51
4.8
0.05 / 0.25
1 NETA = norethindrone acetate
2 Based on in vivo/in vitro flux data, delivery of both components per day via skin of average permeability (interindividual variation in skin permeability is approximately 20%).

Estradiol USP (estradiol) is a white to creamy white, odorless, crystalline powder, chemically described as estra-1,3,5(10)-triene-3,17b -diol. The molecular weight of estradiol is 272.39 and the molecular formula is C18H24O2.

Norethindrone acetate USP is a white to creamy white, odorless, crystalline powder, chemically described as 17-hydroxy-19-nor-17a -pregn-4-en-20-yn-3-one acetate. The molecular weight of norethindrone acetate is 340.47 and the molecular formula is C22H28O3.

The structural formulas for estradiol and norethindrone acetate are

CombiPatch (estradiol, norethindrone acetate transdermal system) transdermal systems are comprised of three layers. Proceeding from the visible surface toward the surface attached to the skin, these layers are (1) a translucent polyolefin film backing, (2) an adhesive layer containing estradiol, norethindrone acetate, acrylic adhesive, silicone adhesive, oleyl alcohol, oleic acid NF, povidone USP and dipropylene glycol, and (3) a polyester release protective liner, which is attached to the adhesive surface and must be removed before the system can be used.

The active components of the system are estradiol USP and norethindrone acetate USP. The remaining components of the system are pharmacologically inactive.

What are the possible side effects of estradiol and norethindrone (Combipatch)?

Treatment with estrogens long-term may increase the risk of heart attack, stroke, breast cancer, and blood clots in the lungs or legs. Because of these risks, you should contact your doctor or healthcare provider to discuss your individual risks and benefits before using estradiol and norethindrone long-term. You should also talk to your doctor or healthcare provider on a regular basis (for example, every 3-6 months) about whether you should continue this treatment.

If you experience any of the following serious side...

Read All Potential Side Effects and See Pictures of CombiPatch

What are the precautions when taking estradiol, norethindrone acetate transdermal system (CombiPatch)?

Before using this medication, tell your doctor or pharmacist if you are allergic to estradiol or norethindrone; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: vaginal bleeding of unknown cause, certain cancers (such as breast cancer, cancer of the uterus/ovaries), blood clots, stroke, heart disease (such as heart attack), liver disease, kidney disease, family medical history (especially breast lumps, cancer, blood clots, angioedema), blood clotting disorders (such as protein C or protein S deficiency), high blood pressure, diabetes, high blood...

Read All Potential Precautions of CombiPatch


CombiPatch Consumer (continued)

SIDE EFFECTS: See also Warning section.

Skin redness/irritation at the application site, abdominal pain, nausea/vomiting, bloating, breast tenderness, headache, or weight changes may occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor right away if you have any serious side effects, including: mental/mood changes (such as depression, memory loss), breast lumps, unusual vaginal bleeding (such as spotting, breakthrough bleeding, prolonged/recurrent bleeding), increased or new vaginal irritation/itching/odor/discharge, severe stomach/abdominal pain, persistent nausea/vomiting, yellowing eyes/skin, dark urine, swelling hands/ankles/feet, increased thirst/urination.

This medication may rarely cause serious problems from blood clots (such as heart attacks, strokes, deep vein thrombosis, pulmonary embolism). Get medical help right away if you have any serious side effects, including: chest/jaw/left arm pain, unusual sweating, sudden/severe headache, weakness on one side of the body, confusion, slurred speech, sudden vision changes (such as partial/complete blindness), pain/redness/swelling of legs, tingling/weakness/numbness in the arms/legs, trouble breathing, coughing up blood, sudden dizziness/fainting.

A very serious allergic reaction to this product is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

PRECAUTIONS: Before using this medication, tell your doctor or pharmacist if you are allergic to estradiol or norethindrone; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: vaginal bleeding of unknown cause, certain cancers (such as breast cancer, cancer of the uterus/ovaries), blood clots, stroke, heart disease (such as heart attack), liver disease, kidney disease, family medical history (especially breast lumps, cancer, blood clots, angioedema), blood clotting disorders (such as protein C or protein S deficiency), high blood pressure, diabetes, high blood cholesterol/triglyceride levels, obesity, lupus, underactive thyroid (hypothyroidism), mineral imbalance (low or high level of calcium in the blood), a certain hormone problem (hypoparathyroidism), uterus problems (such as fibroids, endometriosis), gallbladder disease, asthma, seizures, migraine headaches, a certain blood disorder (porphyria), mental/mood disorders (such as dementia, depression).

Do not smoke or use tobacco. Estrogens combined with smoking further increases your risk of stroke, blood clots, high blood pressure, and heart attack, especially in women older than 35.

Tell your doctor if you just had or will be having surgery, or if you will be confined to a chair or bed for a long time (such as a long plane flight). These conditions increase your risk of getting blood clots, especially if you are using an estrogen product. You may need to stop this medication for a time or take special precautions.

This drug may cause blotchy, dark areas of the skin on the face (melasma). Sunlight may worsen this effect. Avoid prolonged sun exposure, tanning booths, and sunlamps. Use a sunscreen and wear protective clothing when outdoors.

If you are nearsighted or wear contact lenses, you may develop vision problems or trouble wearing your contact lenses. Consult your eye doctor if these problems occur.

This medication must not be used during pregnancy. If you become pregnant or think you may be pregnant, tell your doctor immediately.

This medication passes into breast milk. It may reduce the quality and amount of breast milk produced. Consult your doctor before breast-feeding.


CombiPatch Patient Information Including Side Effects

Brand Names: Combipatch

Generic Name: estradiol and norethindrone (topical patches) (Pronunciation: ess tra DYE all and nor ETH in drone)

  • What are estradiol and norethindrone (CombiPatch)?
  • What are the possible side effects of estradiol and norethindrone (CombiPatch)?
  • What is the most important information I should know about estradiol and norethindrone (CombiPatch)?
  • What should I discuss with my healthcare provider before using estradiol and norethindrone (CombiPatch)?
  • How should I use estradiol and norethindrone (CombiPatch)?
  • What happens if I miss a dose (CombiPatch)?
  • What happens if I overdose (CombiPatch)?
  • What should I avoid while using estradiol and norethindrone (CombiPatch)?
  • What other drugs will affect estradiol and norethindrone (CombiPatch)?
  • Where can I get more information?

What are estradiol and norethindrone (CombiPatch)?

Estradiol is a form of estrogen. Estrogen is a female sex hormone that is involved in the development and maintenance of the female reproductive system.

Norethindrone is a form of progesterone. Progesterone is a female hormone important for the regulation of ovulation and menstruation.

Together, estradiol and norethindrone 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 flashes" or "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 replace estrogen in conditions such as hypogonadism, removal of the ovaries, or primary ovarian failure that result in a lack of estrogen.

Estradiol and norethindrone may also be used for purposes other than those listed in this medication guide.

What are the possible side effects of estradiol and norethindrone (CombiPatch)?

Treatment with estrogens long-term may increase the risk of heart attack, stroke, breast cancer, and blood clots in the lungs or legs. Because of these risks, you should contact your doctor or healthcare provider to discuss your individual risks and benefits before using estradiol and norethindrone long-term. You should also talk to your doctor or healthcare provider on a regular basis (for example, every 3-6 months) about whether you should continue this treatment.

If you experience any of the following serious side effects, stop using estradiol and norethindrone and seek emergency medical attention or notify your doctor immediately:

  • an allergic reaction (difficulty breathing; closing of the throat; swelling of the lips, tongue, or face; or hives);
  • sharp chest pain, coughing of blood or shortness of breath (possible blood clot in the lung );
  • pain in the calf (possible blood clot in the leg);
  • crushing chest pain or heaviness in the chest (possible heart attack);
  • sudden severe headache or vomiting, dizziness or fainting, disturbances of vision or speech, weakness, or numbness in an arm or leg (possible stroke);
  • partial or complete loss of vision (possible clot in the eye);
  • stomach pain or tenderness, yellowing of the skin or eyes, fever, fatigue, loss of appetite, dark-colored urine, or light-colored stools (possible liver problems); or
  • new or changing breast lumps.

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

  • nausea and vomiting;
  • tenderness or enlargement of the breasts;
  • weakness;
  • swelling of the hands or feet;
  • spotty darkening of the skin, particularly on the face;
  • difficulty in wearing contact lenses;
  • vaginal irritation or discomfort;
  • a rash or reaction at the patch application site; or
  • changes in menstrual cycle, painful menstruation, or breakthrough bleeding.

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

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. You may report side effects to FDA at 1-800-FDA-1088.

What is the most important information I should know about estradiol and norethindrone (CombiPatch)?

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

Treatment with estrogens long-term may increase the risk of heart attack, stroke, breast cancer, and blood clots in the lungs or legs. Because of these risks, you should contact your doctor or healthcare provider to discuss your individual risks and benefits before using estradiol and norethindrone long-term. You should also talk to your doctor or healthcare provider on a regular basis (for example, every 3-6 months) about whether you should continue this treatment.

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

Do not use this medication if you are pregnant.

Do not place the transdermal patch on your breasts or at your waistline where tight-fitting clothing may interfere with its functioning.

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