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The US Food and Drug Administration approved the contraceptive implant system, Norplant, in February 1990. It has been used in other countries for more than 15 years before the US approved it. The 6 subdermally placed capsules in the upper inner arm release 50-80 mcg levonorgestrel/day into the bloodstream, resulting in a 99.8% efficacy rate. Patient education and counseling, especially about changes in the bleeding pattern and Norplant's inability to protect against sexually transmitted diseases, are important to maintain client satisfaction and continued use of Norplant. Side effects, from most to least common, are changes in menstrual bleeding, constant bleeding, missed periods, weight gain/increased appetite, headache, oily skin or acne, weight loss/nausea, breast tenderness, nervousness or loss of appetite, and hair loss. It is rare when complications are so severe that they require removal of the implants. Contraindications to Norplant include active liver disease, active thromboembolic disease, breast cancer, pregnancy, and undiagnosed dysfunctional uterine bleeding. Antiepileptic medications, barbiturates, treatment for tuberculosis, and Butazolidin/phenylbutazone reduce Norplant's efficacy. A trained person should insert Norplant within the first 5-7 days of the menstrual cycle when it is evident there is no pregnancy. Some reports recommend that, after childbirth, it should be inserted 6 weeks postpartum to avoid hemorrhage. Yet, nurse-midwives at the Center for Addiction and Pregnancy at the Francis Scott Key Medical Center in Baltimore, Maryland, insert Norplant 24-48 hours postpartum in non-breast-feeding mothers with no increase in hemorrhage. Norplant must be removed no longer than 5 years after insertion. Certified nurse-midwives wanting to incorporate Norplant into their practices should follow the Guidelines for the Incorporation of New Procedures into Nurse-Midwifery Practice and have available a consulting physician who is familiar with and skilled in inserting Norplant. The manufacturer conducts training sessions for health professionals.
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PMID:Subdermal contraceptive implants in nurse-midwifery practice. 848 13

The levonorgestrel (LNg) IUD releases 20 mcg LNg/day and protects against pregnancy for 5 years (Pearl index = 0.1/100 women years of use). Its mode of action is reduced amount of cervical mucus and suppression of the endometrium. A multicenter study in Denmark, Finland, Hungary, and Sweden comparing the LNg IUD and the Nova T IUD found the 5-year continuation rate of the LNg IUD to be 46.9% (44.5% for Nova T). The leading reasons for LNg IUD removal at 5 years were planning pregnancy (15.2%), bleeding (13.7%), and hormonal reasons (11.9%). Bleeding disturbances occurred significantly less often in the LNg IUD users than in the Nova T users (13.7% vs. 20.7%; p = .002). Since LNg has a strong effect on endometrium suppression, LNg IUD users were more likely to quit using the IUD due to amenorrhea than Nova T users (6% vs. 0; p = .0001). The cumulative gross expulsion rate after 5 years was 5.8. Termination for genital infections was more likely in Nova T users than LNg IUD users, especially when the infections were pelvic inflammatory disease (2.2% vs. 0.8%; p .01) and endometritis (4% vs. 1.5%; p .01). Hormonal side effects were acne, hirsutism, weight changes, mood changes, breast tenderness, nausea, and headache. Women in the LNg IUD group experienced return to fertility at a higher rate than those in the Nova T group (79.1% at 12 months and 86.6% at 24 months vs. 71.2% and 79.7%, respectively), but the differences were not significant. Progestin-releasing IUDs can be used to treat menorrhagia, thereby making them an alternative to hysterectomy or endometrial resection. The LNg IUD reduced menstrual blood loss by 86% at 3 months and by 97% at 12 months in women with menorrhagia, resulting in an increase in hemoglobin and serum ferritin. This IUD also effectively opposes the proliferative effect of estrogen on the endometrium in women on hormonal replacement therapy.
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PMID:Hormonal intrauterine devices. 848 51

The newer progestogens gestodene, desogestrel and norgestimate were developed in an attempt to produce agents with more selective progestational activity that would improve cycle control and minimise metabolic changes and adverse events while effectively preventing pregnancy. In clinical practice, gestodene is combined with ethinylestradiol in monophasic or triphasic combined oral contraceptive preparations. The drug has pharmacokinetic advantages over the other new progestogens in that it is active per se (the others are prodrugs) and has high bioavailability (approximately 100%). The ability of gestodene-containing oral contraceptives to inhibit ovulation is similar to that of preparations containing other progestogens although the required dosage is lower. In common with oral contraceptives containing desogestrel or norgestimate, and in contrast with those containing levonorgestrel, gestodene-containing preparations are associated with neutral or positive changes in lipid and carbohydrate metabolism. The effects of gestodene preparations on coagulation parameters, like those of desogestrel and levonorgestrel, are balanced by changes in the fibrinolytic system. Although the impact of these changes on clinical cardiovascular end-points has not been determined, the altered lipid profile is not likely to have significant clinical relevance because of the predominantly thrombogenic nature of cardiovascular disease in oral contraceptive users. Pregnancy rates and Pearl Indices with gestodene-containing preparations are low and similar to those with preparations containing other progestogens. Most pregnancies are attributable to user failure. Cycle control appears to be better with gestodene preparations than with levonorgestrel preparations, and available data suggest that cycle control may also be better with monophasic gestodene/ethinylestradiol than with monophasic desogestrel- or norgestimate-containing preparations, and better with triphasic gestodene- than with triphasic levonorgestrel- or norgestimate-containing preparations. However, differences between the new progestogen-containing preparations need to be confirmed in further large-scale trials. The most common adverse events with gestodene/ethinylestradiol are headaches and breast tension; the incidence of short term adverse events, including acne, is similar to that with preparations containing other progestogens. Changes in blood pressure and bodyweight are negligible. There are no comparative data on the incidence of cardiovascular events with gestodene-containing and other combined preparations. While the risk of breast cancer appears to be increased with long term combined oral contraceptive use in certain patient subgroups, this risk needs to be balanced against the noncontraceptive benefits of these preparations.(ABSTRACT TRUNCATED AT 400 WORDS)
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PMID:Gestodene. A review of its pharmacology, efficacy and tolerability in combined contraceptive preparations. 852 63

Because no contraceptive agent is perfect, patients must weigh the benefits and risks of the contraceptive method they decide to initiate and continue. Individual decision making and provider-client communication interact in complex ways to determine contraceptive behavior. Use of the contraceptive injectable depot medroxyprogesterone acetate (DMPA) should be preceded by counseling which individualizes its risks and benefits, answers all questions (asked and unasked), and develops a longterm plan to minimize side effects. Counseling should cover the contraceptive and noncontraceptive benefits of DMPA; specific side effects such as bleeding changes, weight changes, and fertility changes; the mechanisms of action; and ways to avoid acquiring sexually transmitted diseases. When evaluating and managing side effects, a differential diagnosis independent of DMPA must be considered first (especially for postcoital bleeding and headache). A pregnancy test should be offered in the first month of amenorrhea, after which no treatment is necessary. Ovulation resumption after use may be spontaneous or may be induced with menotropin therapy. Spotting and breakthrough bleeding may be handled by counseling or by a short course of high-dosage ibuprofen or of low-dose estrogen supplementation. Counseling may help women manage weight gain through caloric reduction and an increase in exercise. Acne which occurs soon after adoption of the method may be managed pharmacologically. Increased intake of dietary fiber and fluids may ameliorate the symptoms of abdominal bloating, and temporary nausea can be treated with antacids. Recent research has shown that depression does not increase with DMPA use, although the contraceptive is sometimes implicated in mood changes. Breast tenderness decreases with prolonged DMPA usage and can be managed with proper support garments and a reduction in other causative agents such as caffeine. Women who experience an increase in varicose veins should wear support hose and elevate their legs when possible. Women with symptoms of hypoestrogenic side effects should undergo a serum estradiol level test and appropriate replacement therapy. DMPA can be used immediately postpartum even in breast-feeding women. Women with amenorrhea should be tested for pregnancy before initiating DMPA or reinitiating use at an interval longer than 11-13 weeks. No adverse side effects have been found if pregnancy does occur.
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PMID:Counseling issues and management of side effects for women using depot medroxyprogesterone acetate contraception. 872 1

US teenagers have had access to the injectable contraceptive depot medroxyprogesterone acetate (DMPA; Depo-Provera) since the US Food and Drug Administration approved it in 1992. DMPA suppresses follicle stimulating hormone and luteinizing hormone (LH) levels, which in turn prevents the LH surge and thus inhibits ovulation. It also causes a thick cervical mucus (reducing sperm penetration). Since DMPA also changes tubal mobility and creates shallow and atrophic endometrium, implantation is prevented. DMPA must be administered every 3 months to be effective. Its first-year failure rate is 0.3%, which is lower than that of oral contraceptives (3%). Advantages of DMPA are that it: allows for privacy; improves compliance (since action is required every 3 months rather than every day); has no estrogen-related complications (e.g., thrombophlebitis); is effective; is safe for breast feeding teenagers; reduces seizure frequency in teenagers with epilepsy; has a favorable effect on sickle cell disease or coagulopathy; reduces menstrual flow, thus preventing iron-deficiency anemia; reduces menstrual pain and pre-menstrual symptoms; and decreases risk of pelvic inflammatory disease. The leading disadvantages are menstrual irregularities and spotting. Some other possible disadvantages include weight gain (most common reason for discontinuation), delayed return of fertility, headaches, acne, and nervousness. Health providers must perform a complete history of teenagers requesting DMPA. They should determine the presence or absence of absolute and relative contraindications to DMPA. Absolute contraindications are known or suspected pregnancy, undiagnosed or abnormal vaginal bleeding, known or suspected history of breast cancer, acute liver disease or jaundice, thromboembolism, and sensitivity to DMPA. DMPA is administered intramuscularly at a concentration of 150 mg/ml. Health providers need to use a frank, nonjudgmental, empathic, and unhurried approach to facilitate a trusting relationship and rapport with teenagers. Advanced counseling on the pros and cons of DMPA, how DMPA works, and DMPA's inability to protect against sexually transmitted diseases is essential.
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PMID:Use of depo-provera in teens. 892 Mar 51

To improve counseling services for new users of the levonorgestrel-releasing contraceptive implant (Norplant), the 251 women who had the implant inserted through the Ohio State University Department of Obstetrics and Gynecology during 1991-94 were mailed a questionnaire concerning their experiences. Responses were received from 111 (44%) of these women; 24 (21.6%) had already had the implants removed after a mean duration of use of 14.6 months, 32 (28.8%) planned on early removal, and 55 (49.5%) desired continued use. There were no significant differences between these 3 groups in terms of age, gravidity, parity, type of provider, or interval between counseling and placement. Among women who planned to continue Norplant use, 98% had been provided with reading material as part of their preinsertion counseling and 95% characterized this counseling as adequate; these rates were significantly lower in the other 2 groups. Frequently reported side effects included menstrual changes (80%), weight gain (53%), headache (50%), mood changes (59%), mastalgia (47%), and acne (47%). Menstrual irregularities, mood changes, and headaches were the side effects cited most frequently among women who opted for early removal. Overall, 75 users (68%) were satisfied or very satisfied with the method, 15 (14%) were somewhat dissatisfied, and 18 (16%) were very dissatisfied. Consistent distribution during preinsertion counseling of reading materials on Norplant and its side effects is recommended to enhance method acceptance.
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PMID:Patient satisfaction with a levonorgestrel-releasing contraceptive implant. Reasons for and patterns of removal. 895 Nov 37

In this clinical practice exchange, nurse-midwives in a variety of settings and US regions describe their treatment strategies for addressing the side effects associated with depot medroxyprogesterone acetate (DMPA). Although DMPA is a safe, effective, long-acting method of hormonal contraception, this injectable has been linked with side effects such as weight gain, menstrual changes, headache, dizziness, acne, abdominal bloating, breast swelling, depression, reduced libido, and alopecia. Approximately one-third of DMPA acceptors discontinue use by the end of the first year and half discontinue by the end of the second year, primarily because of these side effects. Nurse-midwives report that adolescents who are unable to take the pill consistently and breast-feeding women are ideal candidates for DMPA use. Constant vaginal bleeding, the most troublesome side effect, can be treated through use of ibuprofen, oral estrogen, or oral DMPA. Potential or actual weight gain can be averted through life-style changes such as reduced dietary fats and increased exercise. Unanticipated pregnancies can be avoided by administering the initial DMPA injection within 5 days after the onset of menses. Pre-acceptance anticipatory counseling, along with regular support and encouragement, increase user satisfaction with DMPA.
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PMID:Depot medroxyprogesterone. Management of side-effects commonly associated with its contraceptive use. 910 18

The side effects of oral contraceptives (OCs) can be minimized by appropriate OC selection. Side effects or perceived side effects that manifest themselves physically--e.g., weight gain, breakthrough bleeding (BTB), nausea, headache, breast tenderness, mood swings, acne, and hirsutism--are the most common causes of premature discontinuation of oral contraception. The relative androgenicity of the progestin component of combination OCs has become an important differential in selecting OC formulations. Several studies have indicated that preparations with less androgenic potential can minimize some of the "physical" side effects and adverse metabolic effects traditionally associated with oral contraception. Acne and hirsutism, common pre-existing conditions that are clearly related to the androgenicity of the progestin component, can be eliminated or improved by use of OCs with low androgenic activity. Many women perceive that OCs cause weight gain; although weight gain is to some extent androgen related, most studies comparing low-androgenic OCs with medium- or high-androgenic preparations have found little or no change in weight regardless of formulation. BTB, which usually subsides within a few months, is related to the dose, potency, and ratio of the estrogen and progestin in the OC formulation. Low-estrogen-dose OCs (< or = 35 micrograms ethinyl estradiol [EE]) containing less androgenic progestins are associated with bleeding patterns as acceptable as older low-estrogen-dose formulations. The same analysis found that smoking cigarettes promotes BTB in women who use OCs. There is no convincing evidence that the use of one progestin or another is less likely to cause or exacerbate headache; however, changing preparations sometimes reduces the incidence. Women with persistent headaches during the pill-free interval may benefit from a longer cycle of OC treatment. Nausea and breast tenderness are primarily estrogen-related effects; if a women experiences persistent nausea, switching to an OC formulation containing 20 micrograms EE may be appropriate as long as the patient is cautioned that BTB is more likely. Mood changes are a common, highly subjective complaint whose relationship to OC use is hard to assess. Concerns about the potentially deleterious effects of combination OCs on lipid/lipoprotein and carbohydrate metabolism have been substantially diminished by new epidemiologic findings relative to cardiovascular disease as well as by the development of low-androgenic progestins. Formulations containing these progestins lower LDL cholesterol and increase HDL cholesterol; they do not affect carbohydrate metabolism as much as older, more androgenic formulations.
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PMID:OC practice guidelines: minimizing side effects. 916 75

Although Thailand's National Family Planning Program introduced Norplant contraceptive implants in 1986, few women infected with human immunodeficiency virus (HIV) select this method, and its efficacy, clinical effects, and side effects in this population have not been investigated. To address these issues, a prospective cohort study was conducted during 1993-96 of 41 asymptomatic HIV-infected women who presented to the Family Planning Clinic at Ramathibodi Hospital in Bangkok, Thailand, and voluntarily accepted Norplant implants. All implants were inserted within 4 weeks after delivery or abortion. 63.4% of acceptors had not used any contraceptive method prior to pregnancy. At 6 and 12 months after insertion, 26% and 23%, respectively, reported irregular menstrual periods and 24.4% and 36.6%, respectively, reported amenorrhea. Side effects, reported by 3-10% of women, included headache, acne/chloasma, anorexia, and nausea. There were no significant changes in body weight, blood pressure, and hemoglobin between insertion and the 12-month follow-up. No pregnancies occurred during the study period. These findings suggest that Norplant implants are an effective, appropriate contraceptive method for HIV-infected women who want to avoid pregnancy but are not interested in sterilization.
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PMID:Use of Norplant implants in asymptomatic HIV-1 infected women. 917 51

The efficacy and tolerability of treatment of adenomyosis-related menorrhagia with a levonorgestrel-releasing IUD were investigated in a prospective study of 25 women recruited from a tertiary care center in Italy. All women reported recurrent menorrhagia of at least 6 months' duration and underwent abdominal and transvaginal ultrasonography, hysteroscopy, and endometrial biopsy before study entry. An IUD releasing 20 mcg/day of levonorgestrel was inserted within 7 days of the onset of menses and follow-up examinations were conducted 3, 6, and 12 months after insertion. 1 woman experienced IUD expulsion 2 months after insertion and another requested removal at 4 months because of persistent irregular blood loss. 6 months after IUD insertion, amenorrhea was observed in 2 women, oligomenorrhea in 1 woman, and occasional spotting in 7 women; the remaining 13 women had scanty but regular periods. At 12 months, 2 women reported amenorrhea, 3 had oligomenorrhea, 2 had spotting, and 16 had regular periods. All menstrual anomalies were well tolerated. IUD-related side effects included headache (24%), breast tenderness (16%), seborrhea or acne (24%), and weight gain (28%). Significant increases in hemoglobin, hematocrit, and serum ferritin were recorded; there were no changes in lipid metabolism or clotting variables. These findings suggest that insertion of a levonorgestrel-releasing IUD represents a viable alternative to hysterectomy in the treatment of adenomyosis. It is speculated that the IUD produces deciduation and subsequent marked hypotrophy of eutopic endometrium.
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PMID:Treatment of adenomyosis-associated menorrhagia with a levonorgestrel-releasing intrauterine device. 931 8


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