CombiPatch
Hormones May Not Raise Alzheimer's Risks »
"Oct. 24, 2012 -- Women who take hormones within five years of menopause may have a slightly lower risk of Alzheimer's disease compared to women who don't ever take them, a new study shows.
The study, which is published in the journal"...
CombiPatch
SIDE EFFECTS
See BOXED WARNINGS, 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. The adverse reaction information from clinical trials does, however, provide a basis for identifying the adverse events that appear to be related to drug use and for approximating rates.
| CombiPatch 0.05/0.14 mg per day1 n = 113 | CombiPatch 0.05/0.25 mg per day1 n = 112 | Placebo 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% |
| 1 Represents milligrams of estradiol/NETA delivered daily by each system | |||
| Table V. All Treatment Emergent Study Events Regardless of Relationship Reported at a Frequency of 5% with CombiPatch ENDOMETRIAL HYPERPLASIA STUDIES | |||
| CombiPatch 0.05/0.14 mg per day1 n = 325 | CombiPatch 0.05/0.25 mg per day1 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% |
| 1 Represents milligrams of estradiol/NETA delivered daily by each system | |||
The following additional adverse reactions have been reported with estrogen and/or progestin therapy.
1. Genitourinary system
Changes in vaginal bleeding pattern and abnormal withdrawal bleeding or flow; breakthrough bleeding; spotting; dysmenorrhea, increase in size of uterine leiomyomata; vaginitis, including vaginal candidiasis; change in amount of cervical secretion; changes in cervical ectropion; ovarian cancer; endometrial hyperplasia; endometrial cancer.
2. Breasts
Tenderness, enlargement, pain, nipple discharge, galactorrhea; fibrocystic breast changes; breast cancer.
Deep and superficial venous thrombosis; pulmonary embolism; thrombophlebitis; myocardial infarction; stroke; increase in blood pressure.
Nausea, vomiting; abdominal cramps, bloating; cholestatic jaundice; increased incidence of gallbladder disease; pancreatitis, enlargement of hepatic hemangiomas.
5. Skin
Chloasma or melasma, that may persist when drug is discontinued; erythema multiforme; erythema nodosum; hemorrhagic eruption; loss of scalp hair; hirsutism; pruritus, rash.
6. Eyes
Retinal vascular thrombosis, intolerance to contact lenses.
Headache; migraine; dizziness; mental depression; chorea; nervousness; mood disturbances; irritability; exacerbation of epilepsy, dementia.
8. Miscellaneous
Increase or decrease in weight; reduced carbohydrate tolerance; aggravation of porphyria; edema; arthalgias; leg cramps; changes in libido; urticaria, angioedema, anaphylactoid/anaplylactic reactions; hypocalcemia; exacerbation of asthma; increased triglycerides.
Read the CombiPatch (estradiol, norethindrone acetate transdermal system) Side Effects Center for a complete guide to possible side effects »
DRUG INTERACTIONS
1. Accelerated prothrombin time, partial thromboplastin time, and platelet aggregation time; increased platelet count; increased factors II, VII antigen, VIII antigen, VIII coagulant activity, IX, X, XII, VII-X complex, II-VII-X complex; and beta-thromboglobulin; decreased levels of anti-factor Xa and antithrombin III; decreased antithrombin III activity; increased levels of fibrinogen and fibrinogen activity; increased plasminogen antigen and activity.
2. Increased thyroid-binding globulin (TBG) leading to increased circulating total thyroid hormone, as measured by protein-bound iodine (PBI), T4 levels (by column or by radioimmunoassay) or T3 levels by radioimmunoassay. T3 resin uptake is decreased, reflecting the elevated TBG. Free T4 and free T3 concentrations are unaltered. Patients on thyroid replacement therapy may require higher doses of thyroid hormone.
3. Other binding proteins may be elevated in serum (i.e., corticosteroid binding globulin (CBG), sex hormone binding globulin (SHBG), leading to increased circulating corticosteroids and sex steroids, respectively. Free hormone concentrations may be decreased. Other plasma proteins may be increased (angiotensinogen/renin substrate, alpha-1-antitrypsin, ceruloplasmin).
4. Increased plasma HDL and HDI2 subfraction concentrations, reduced LDL cholesterol concentration, increased triglycerides levels.
5. Impaired glucose tolerance.
6. Reduced response to metyrapone test.
Last reviewed on RxList: 10/5/2006
This monograph has been modified to include the generic and brand name in many instances.
Additional CombiPatch Information
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