Gene/Protein Disease Symptom Drug Enzyme Compound
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Query: UMLS:C0027497 (nausea)
 23,468 document(s) hit in 31,850,051 MEDLINE articles (0.00 seconds)

The Norplant System consists of 6 capsules each containing 36 mg of crystal line levonorgestrel (LNG), for a total dose of 216 mg LNG. The capsules are inserted subdermally in the mid-upper arm, and LNG diffuses continuously through the capsule walls for 5 years. In the United States the Norplant System was approved in December 1990. The initial rate of hormone delivery is about 85 mcg/day, then decreases over the next 9 months to 5 mcg/day, and over the ensuing 9 months to 35 mcg/day. Thereafter, the diffusion rate levels off for the next 3.5 years, averaging around 30-35 mcg/day. Removal results in a drop in the plasma concentration of levonorgestrel to below contraceptive levels within 24 hours and below the detectable limit of .1 pg/ml at 96 hours. Preliminarily data from 402 users over 5 years show improvements of Norplant produced better efficacy in all weight classes and a lowered cumulative rate of 1.1 pregnancies of 100 users. The pregnancy rate for the first year of use is 02., better than for oral contraceptives. Side effects include headache, nervousness, nausea, dizziness, dermatitis, acne, change of appetite, breast tenderness, minimal weight gain, some change in hair distribution, and adnexal enlargement. Adverse reactions include breast discharge, possible cervicitis, musculoskeletal pain, abdominal discomfort, leukorrhea, and vaginitis. More than the usual number of bleeding days occurred in slightly more than one fourth of the patients, prolonged bleeding in 27.6% spotting in 17.1% and amenorrhea in 9.4% of patients. Hyperlipidemic users should be observed for possible low-density lipoprotein elevations. The cumulative discontinuation rate for pregnancy was 3.9 per 100 users; for bleeding irregularities the rate was 25.1 per 100 users, and for other medical results it was about 22.4 per 100 users. Personal reasons for discontinuation accounted for 38.7 per 100 users, equivalent to a cumulative continuation rate of about 30 per 100 users over the 5-year duration.
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PMID:The NORPLANT system of contraception. 168 4

This literature review compares the merits and disadvantages of the levonorgestrel-releasing IUD made by Leiras Pharmaceuticals, Turkey, Finland (LNG-IUD-20), with the Nova-T, Copper-T (TCu) and 220C, and Copper-T-38-Ag (TCu-380Ag). This IUD releases 20 mcg levonorgestrel daily from a Silastic sleeve on the vertical shaft containing 52 mg. The plasma level stabilized after a month at about 0.2 ng/ml, about half as high as that seen with Norplant implants. It is identical in size to the Nova-T. The Cu-T IUDs differ with respect to copper wire or sleeves, or silver-cored wire. The chief studies reviewed here were 2 multi-center trails primarily in European countries, and a 2 large multi-center trials in India. Cumulative pregnancy rates were 0.0 to 0.6 per 100 users for the LNG IUD, compared to slightly higher failures for inert or copper IUDs. While removal rates for bleeding, pain and pelvic inflammatory disease were lower for the LNG-IUD-20, removals for oligomenorrhea, amenorrhea and hormonal side effects were higher than for the other IUDS. In the Indian trials, removals for amenorrhea and irregular bleeding were much higher than rates reported in the European studies, resulting in significantly lower continuation rates overall. The results pointed to district benefits for the LNG-IUD-20, such as lower blood loss and anemia, relief of dysmenorrhea and menorrhagia, as well as possible lower risks of ectopic pregnancy in case of failure, less PID (pelvic inflammatory disease), and the claim by the maker that strictly correct placement is not necessary. Disadvantages of the LNG-IUD-20 are more difficult insertion due to the wider diameter; oligomenorrhea, amenorrhea and irregular bleeding; hormonal side effects such as acne, weight gain, nausea, headache and breast tension; and potential risk of functional ovarian cysts. The LNG-IUD-20 is considered comparable to copper IUDs in effectiveness, safety, longevity, and return to fertility after removal. Users should be counseled that the oligomenorrhea or amenorrhea is neither a medical problem or indicative of infertility, is common for the 1st 2 months, is reversible on removal, may signal an improved hemoglobin profile, relief of dysmenorrhea, and may be preferred to heavy bleeding from other IUDS. The program implications of this IUD are potential lower incidence of ectopic pregnancy and PID. The effect of its use on breast feeding, cost-effectiveness compared to Norplant, in-country manufacture, and cultural acceptance need to be determined in specific locales.
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PMID:An evaluation of the levonorgestrel-releasing IUD: its advantages and disadvantages when compared to the copper-releasing IUDs. 177 15

This is a review of the impact of spinal cord injury on female sexuality, which has received far less attention than male sexuality, and on menstruation, contraception and pregnancy, which have been reported more extensively. The few reports of sexuality in women after spinal cord injury suggests a wide range of adaptability, from 40% to 88% of the subjects achieving satisfactory sexual activity. Some women were able to adapt a positive body image and find new ways of stimulation to orgasm, despite altered body shape, bladder and bowel incontinence, spasticity, and lack of sensation often resulting from spinal injury. The pill, vaginal methods, and IUDs are not recommended, but condoms and possibly Norplant, are appropriate for these women. Menstruation, often ceasing for several months after injury, usually resumes. One study reported lack of menstrual pain, others did not. Many spinal injuries women have achieved 1 or more pregnancies. A few cases have been described of successful pregnancy when the injury occurred during gestation, as has 1 intrauterine death that was successfully delivered by induction. Premature cervical dilatation and labor and small-for-dates infants are more common than usual, but spontaneous abortion are not. Some of the typical problems in pregnancy are urinary tract infections, decubiti, anemia, pedal edema, weight transfer problems, thrombophlebitis, TIA episodes, and nausea. A more serious problem is management of labor, especially if the woman cannot perceive labor pains, or cannot bear down. Frequent check-ups and early hospitalization are recommended. A potentially fatal risk in those injured at T6 or above, is autonomic dysreflexia, stimulated by induction, labor, delivery, or even breast feeding. Autonomic dysreflexia can be treated with epidural anesthesia with lidocaine. Induction is contraindicated. Lactation may cease after 3 months or so because of lack of nipple stimulation.
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PMID:The impact of spinal cord injury on female sexuality, menstruation and pregnancy: a review of the literature. 188 48

The International Planned Parenthood Federation (IPPF) new statement on the diagnosis of pregnancy was drawn up in April 1990. A pregnancy diagnosis includes clinical evaluation of the woman's history, symptoms, physical examination, and pregnancy tests. Pregnancy symptoms may include amenorrhea, nausea, vomiting, enlargement and tenderness of the breasts, frequent urination, and changes in appetite and food and drink habits. If biochemical testing is not possible, a reliable clinical diagnosis of pregnancy cannot take place before 6-8 weeks. At this time, the clinician can observe cervical softening and uterine softening and enlargement if a woman is pregnant. If the uterine size does not match the length of amenorrhea, clinicians should suspect the following: earlier or later conception than indicated, ectopic pregnancy, incomplete or missed spontaneous abortion, twin gestation, hydatidiform mole, or other uterine anomaly. They should suspect ectopic pregnancy in women with smaller than expected uterine size when they have been sterilized or are using an IUD or are using low-dose progestogen-only pills or Norplant. They should refer women with smaller than expected uterine size who are experiencing bleeding and/or pain to a more sophisticated clinical facility, where an accurate diagnosis of and adequate treatment for ectopic pregnancy can be done. Biochemical pregnancy tests consist of antibodies that mark human chorionic gonadotropin (hCG) from a urine or serum sample. hCG levels increase beginning about 10 days after fertilization. The most convenient and inexpensive pregnancy test for clinics is the immunoassay test (slide test), which requires a urine or serum sample. It can provide reliable results a few days after the missed menstrual period. Clinicians should provide appropriate counseling regardless of whether the client wishes to continue or terminate the pregnancy.
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PMID:New IPPF statement on the diagnosis of pregnancy. 192 37

Oral contraceptives (OCs, long-acting progestins (LAPs), and IUDS are reviewed in terms of new information on safety and efficacy. OC formulations are described and their mechanism of action and efficacy indicated. Reports are provided for thromboembolism, hemorrhagic and thrombotic stroke, ischemic heart diseases, alterations in lipid and hypoprotein and carbohydrate metabolism, hypertension, coagulation changes, breast and cervical cancers, and such minor side effects as menstrual irregularities, nausea, headaches, weight gain, premenstrual syndrome effects, and mood and libido changes. Noncontraceptive health benefits and clinical considerations are discussed. Norplant, as the only long acting progestin available in the US is described in terms of its formulations, mechanism of action, sequelae and metabolic effects, menstrual irregularities, metabolic effects, nuisance side effects, candidates for insertion, method of insertion and removal, and continuation rates. 2 IUD types are identified as the only ones available in the US, Progestasert T and T-Cu-380A (Paragard). Mechanism of action, efficacy, candidates, major sequelae such as salpingitis, infertility, and uterine perforation, minor sequelae such as metrorrhagia and dysmenorrhea, and other considerations are indicated. OCs in the US contain an average of 35 mg of ethinyl estradiol and assorted progestins e.g.s, ethynodiol diacetate, norethindrone acetate, nortestosterone derivatives with a complex mechanism of action. The failure rate for use effectiveness is 6 pregnancies/100 woman years. Modern formulations have combined rates of no more than 50 to 100 adverse events/100,000 users. Some of the effects are indicated as follows: Thromboembolism accounts for 60% of adverse effects and appears to be declining along with hemorrhagic and thrombotic stroke, however, modern use studies are only partially available. Myocardial infarction related to OC use may be embolic, and has a low risk at 7/100,000 users. Low-dose contraceptives substantially reduce the associated risks. Those with risk factors need close monitoring. Norplant is useful for those not wanting to take a daily regimen and is commonly accompanied by menstrual irregularity and sometimes headaches. Continuation is 80% after the 1st year and 40% after 5 years. Candidates for IUDs are parous women in monogamous relationships, who are not at risk for salpingitis, which is related to IUD use, or sexually transmitted diseases. Continuation is 70% after 1 year compared with 50% of OC users.
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PMID:Modern trends in contraception. 212 11

This prospective study of 122 Black and Hispanic inner-city adolescent Norplant users recruited from a teen clinic in Rochester, New York, was the first to include a two-year follow-up period. The study period extended from June 1, 1991, to June 30, 1993. The mean age of Norplant acceptors was 17.4 years; 76% had a parity of at least one. Recorded was a one-year retention rate of 71% and a two-year rate of 62%. The greatest number of removals occurred in the first three months after insertion. There was no association between Norplant retention and age, weight, race, parity, or school status. The only significant predictor of Norplant continuation was a history of at least one induced abortion. The reasons most frequently cited by the 30 adolescents who discontinued Norplant were headache, fatigue, hair loss, nausea, weight changes, breast symptoms, and appetite changes. Menstruation irregularities were reported only by terminators in the 3-6 month use interval. Considering the high continuation rates recorded in this survey and the method's proven effectiveness, Norplant has the potential to widen substantially the birth interval between adolescent pregnancies.
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PMID:Contraceptive implant use among inner city teens. 766 90

During the period of March-October 1993 Norplant was implanted in 58 women who appeared at first, third, and sixth monthly control examinations at the OB/GYN Service, US Army Hospital, Berlin, Germany. The six rods were inserted under local anesthesia within 4-5 minutes. The average age was 24.6 years, and they were counseled individually after watching a video film about the procedure. One month after the implantation the skin appeared normal without hematoma or infection. Only 2 women had a regular menstrual cycle in the course of six months, but no pregnancy occurred. 27 women (46.5%) reported at least one side effect. Most frequent was weight gain (21 cases, or 36.2%); other side effects were headache (8 cases, or 13.2%), loss of hair (5 cases, or 8.6%), mood changes (5 cases, or 8.6%), fatigue (2 cases, or 3.4%), decreased libido (1 case, or 1.7%), and nausea (1 case, or 1.7%). In women aged 20 years or younger fewer problems occurred than in older women (p 0.025). 54 women had also used oral contraceptives. 25 of these (46.3%) had side effects, i.e., headache, migraine, or nausea. There was an association between the side effects of Norplant and those of oral contraceptives (p 0.025). At the end of the study 86.2% of women (50) reported to be satisfied with Norplant, 10.3% of women (6) said they were not satisfied, and 3.4% of women (2) were undecided. Norplant was removed in 6 cases because of side effects. Among these were 3 women with heavy hair loss, 2 with mood changes, and 1 with increasing headaches. Almost 90% of the women accepted Norplant. It is very important to instruct women in detail about the action of Norplant and counsel them in order to reduce the rate of removals.
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PMID:[Norplant and its side effects]. 779 68

During June 1992-February 1993, physicians in Charlotte, North Carolina, randomly assigned 250 women who had delivered vaginally at the Carolinas Medical Center to receive the contraceptive implant Norplant either before being discharged from the hospital on postpartum day 1, 2, or 3 or 4-6 weeks later at the scheduled postpartum follow-up visit. They wanted to ascertain whether insertion of Norplant in the immediate postpartum period was safe and well-tolerated. 26 women were lost to follow-up. 11 of these women were in the delayed insertion group, so they did not receive Norplant or an alternative contraceptive method, placing them at risk of pregnancy. Another 34 women in the same group returned for their follow-up visit but did not receive Norplant. The mean interval from delivery to insertion stood at 1.7 days for the immediate insertion group and 34.3 days for the delayed insertion group. No one in either group experienced acute postpartum hemorrhage. The immediate insertion group had much more bleeding and spotting than did the delayed insertion group (17 vs. 13.6 days, p 0.01, and 11.1 vs. 8.8 days, p = 0.03, respectively; 28.2 vs. 22.4 days for both spotting and bleeding, p 0.01). Since hemoglobin values of the two groups did not differ (12.9 vs. 12.7), the increased bleeding was not clinically significant. Women in the immediate insertion group were more likely than those in the delayed insertion group to have headaches on at least seven days between insertion and study follow-up (15.1% vs. 2.8%; p 0.01). They also were more likely to have acne during at least three days (18.9% vs. 6.4%; p 0.01). They were just as likely as the delayed insertion group to report nausea, hair loss, and hirsutism. 40% of the women in both groups had sexual intercourse before their 4-6 week follow-up visit. These findings show that Norplant can be safe and well-tolerated if inserted in the immediate postpartum period.
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PMID:Use of Norplant contraceptive implants in the immediate postpartum period: safety and tolerance. 784 30

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

In the Dominican Republic, clinical researchers randomly assigned 150 users of the contraceptive implant Norplant who came to Profamilia's Family Planning Clinic in Santo Domingo complaining of bleeding irregularities to one of three treatment groups. They aimed to evaluate the effectiveness of a combined oral contraceptive (OC) with 250 mcg levonorgestrel and 50 mcg ethinyl estradiol (EE) and of 50 mcg EE alone in treating bleeding irregularities. Bleeding irregularities were defined as prolonged bleeding (i.e., 8 or more continuous days of bleeding or spotting) or irregular bleeding (i.e., current bleeding episode initiated after a bleeding-free interval of less than 15 days). Age, parity, duration of Norplant use, and length of bleeding episode before treatment were similar in all three groups (i.e., OC, EE, and placebo). The OC group was significantly more likely to experience ceased bleeding within three days than the two other groups (91% vs. 67% for EE group [p 0.01 from OC group] and 15% for placebo group [p 0.0005 from both treatments]). Bleeding lasting for at least one week occurred less often in the OC group than the two other groups (2% vs. 14% for EE group and 50% for placebo group [p 0.0005 for both treatments]). Duration of bleeding was significantly lower in the OC group than the other two groups (2.6 days vs. 5.4 days for EE group and 12.3 days for placebo group; p 0.0001). Even though women in both hormonal treatment groups were more likely to experience gastralgia or nausea than the placebo group (33-40% vs. 4%; p 0.005), the side effects rarely interrupted treatment. These findings suggested that the OC is a very good effective treatment for bleeding irregularities and is a practical treatment since it is available at all Profamilia clinic sites.
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PMID:Hormonal treatment for bleeding irregularities in Norplant implant users. 863 69


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