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Indicaciones

CombiPatch is indicated in a woman with a uterus for: Treatment of moderate to severe vasomotor symptoms due to menopause. Treatment of moderate to severe symptoms of vulvar and vaginal atrophy due to menopause. When prescribing solely for the treatment of symptoms of vulvar and vaginal atrophy, topical vaginal products should be considered. Treatment of hypoestrogenism due to hypogonadism, castration, or primary ovarian failure.

Contraindicaciones

CombiPatch is contraindicated in women with any of the following conditions: Undiagnosed abnormal genital bleeding. Known, suspected, or history of breast cancer. Known or suspected estrogen-dependent neoplasia. Active DVT, PE, or history of these conditions. Active arterial thromboembolic disease (for example, stroke and MI), or a history of these conditions. Known anaphylactic reaction or angioedema or hypersensitivity with CombiPatch.

Known liver impairment or disease. Known protein C, protein S, or antithrombin deficiency, or other known thrombophilic disorders. Known or suspected pregnancy.

Advertencias y precauciones

See BOXED WARNING . 1. Cardiovascular Disorders An increased risk of PE, DVT, stroke and MI has been reported with estrogen plus progestin therapy. An increased risk of stroke and DVT has been reported with estrogen-alone therapy. Should any of these occur or be suspected, estrogen with or without progestin therapy should be discontinued immediately. Risk factors for arterial vascular disease (for example, hypertension, diabetes mellitus, tobacco use, hypercholesterolemia, and obesity) and/or venous thromboembolism (VTE) (for example, personal history or family history of VTE, obesity, and systemic lupus erythematosus) should be managed appropriately. a.

Stroke In the WHI estrogen plus progestin substudy, a statistically significant increased risk of stroke was reported in women 50 to 79 years of age receiving daily CE (0.625 mg) plus MPA (2.5 mg) compared to women in the same age group receiving placebo (33 versus 25 per 10,000 women-years). (See CLINICAL STUDIES ) The increase in risk was demonstrated after the first year and persisted. 1 Should a stroke occur or be suspected, estrogen plus progestin therapy should be discontinued immediately.

Indicaciones

Contraindicaciones

Known liver impairment or disease. Known protein C, protein S, or antithrombin deficiency, or other known thrombophilic disorders. Known or suspected pregnancy.

Advertencias y precauciones

Reacciones adversas

See BOXED WARNING , WARNINGS , and PRECAUTIONS . Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. Table 9. All Adverse Reactions Regardless of Relationship Reported at a Frequency of Greater than or Equal to 5 percent with CombiPatch VASOMOTOR SYMPTOM STUDIES CombiPatch 0.05/0.14 mg per day† CombiPatch 0.05/0.25 mg per day† Placebo n=113 n=112 n=107 Body as a Whole 46% 48% 41% Abdominal Pain 7% 6% 4% Accidental Injury 4% 5% 8% Asthenia 8% 12% 4% Back Pain 11% 9% 5% Flu Syndrome 9% 5% 7% Headache 18% 20% 20% Pain 6% 4% 9% Digestive 19% 23% 24% Diarrhea 4% 5% 7% Dyspepsia 1% 5% 5% Flatulence 4% 5% 4% Nausea 11% 8% 7% Nervous 16% 28% 28% Depression 3% 5% 9% Insomnia 3% 6% 7% Nervousness 3% 5% 1% Respiratory 24% 38% 26% Pharyngitis 4% 10% 2% Respiratory Disorder 7% 12% 7% Rhinitis 7% 13% 9% Sinusitis 4% 9% 9% Skin and Appendages 8% 17% 16% Application Site Reaction* 2% 6% 4% Urogenital 54% 63% 28% Breast Pain 25% 31% 7% Dysmenorrhea 20% 21% 5% Leukorrhea 5% 5% 3% Menstrual Disorder 6% 12% 2% Papanicolaou Smear Suspicious 8% 4% 5% Vaginitis 6% 13% 5% †Represents milligrams of estradiol/NETA delivered daily by each system. *Application site reactions includes localized bleeding, bruising, burning, discomfort, dryness, eczema, edema, erythema, inflammation, irritation, pain, papules, paresthesia, pruritus, rash, skin discoloration, skin pigmentation, swelling, urticaria, and vesicles.

Table 10. All Adverse Reactions Regardless of Relationship Reported at a Frequency of Greater than or Equal to 5 percent with CombiPatch ENDOMETRIAL HYPERPLASIA STUDIES CombiPatch 0.05/0.14 mg per day† n=325 CombiPatch 0.05/0.25 mg per day† n=312 Vivelle 0.05 mg per day n=318 Body as a Whole 61% 60% 59% Abdominal Pain 12% 14% 16% Accidental Injury 10% 11% 8% Asthenia 10% 13% 11% Back Pain 15% 14% 13% Flu Syndrome 14% 10% 7% Headache 25% 17% 21% Infection 5% 3% 3% Pain 19% 15% 13% Digestive 42% 32% 31% Constipation 2% 5% 3% Diarrhea 14% 9% 7% Dyspepsia 8% 6% 5% Flatulence 7% 5% 6% Nausea 8% 12% 11% Tooth Disorder 6% 4% 1% Metabolic and Nutritional Disorders 12% 13% 11% Peripheral Edema 6% 6% 5% Musculoskeletal 17% 17% 15% Arthralgia 6% 6% 5% Nervous 33% 30% 28% Depression 8% 9% 8% Dizziness 6% 7% 5% Insomnia 8% 6% 4% Nervousness 5% 6% 3% Respiratory 45% 43% 40% Bronchitis 5% 3% 4% Pharyngitis 9% 9% 8% Respiratory Disorder 13% 9% 13% Rhinitis 19% 22% 17% Sinusitis 10% 12% 12% Skin and Appendages 38% 37% 31% Acne 4% 5% 4% Application Site Reaction* 20% 23% 17% Rash 6% 5% 3% Urogenital 71% 79% 74% Breast Enlargement 2% 7% 2% Breast Pain 34% 48% 40% Dysmenorrhea 30% 31% 19% Leukorrhea 10% 8% 9% Menorrhagia 2% 5% 9% Menstrual Disorder 17% 19% 14% Vaginal Hemorrhage 3% 6% 12% Vaginitis 9% 13% 13% †Represents milligrams of estradiol/NETA delivered daily by each system. *Application site reactions includes localized bleeding, bruising, burning, discomfort, dryness, eczema, edema, erythema, inflammation, irritation, pain, papules, paresthesia, pruritus, rash, skin discoloration, skin pigmentation, swelling, urticaria, and vesicles.

Postmarketing Experience The following additional adverse reactions have been identified during post-approval use of CombiPatch. Because these reactions are reported voluntarily from a population of uncertain size, it is not possible to reliably estimate their frequency or establish a causal relationship to drug exposure. Genitourinary System Endometrial hyperplasia, endocervical polyp, uterine leiomyomata, fallopian tube cyst, uterine spasms.

Breast Breast cancer. Cardiovascular Hypertension, varicose veins. Gastrointestinal Jaundice cholestatic, cholelithiasis, gall bladder disorder, transaminases increased. Skin Skin discoloration. Central Nervous System Affect lability, libido disorder, migraine, vertigo, paresthesia. Miscellaneous Angioedema, hypersensitivity, weight increased.

Presentación	Código	Estado
ESTRADIOL 0.05MG/24HR; NORETHINDRONE ACETATE 0.14MG/24HR	NDA020870-001	Prescription
ESTRADIOL 0.05MG/24HR; NORETHINDRONE ACETATE 0.25MG/24HR	NDA020870-002	Prescription

Combipatch

Indicaciones

Contraindicaciones

Advertencias y precauciones

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Combipatch

Indicaciones

Contraindicaciones

Advertencias y precauciones

¿Dos medicamentos en una misma pregunta?

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