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Prevalence rates of various side effects were studied comparatively among 3 oral contraceptive preparations containing 50 mcg of the estrogen component. Norinyl 1/50, Ovral, and Norlestrin 1 were each randomly assigned to groups of 160 healthy women who had consented to participate in the study designed to quantitate probabilities of experiencing specific side effects and of their continuing into the subsequent cycles. Acne, breast discomfort, nausea, abdominal bloating, headache, fatigue, depression, irritability, vaginal discharge, and breakthrough bleeding were the specific side effects studied; only breakthrough bleedings showed a statistical difference in prevalence. The rate of breakthrough bleeding associated with Ovral use in the 1st 3 cycles (16.6%) was significantly (P .05) lower than that associated with using either Norinyl or Norlestrin (46% and 51.7%, respectively). Norelestrin, aside from breakthrough bleeding, was reported as generally freer of side effects than the other 2 preparations. The probabilities of side effects being experienced in the 2nd or 3rd cycle after the effect(s) was experienced in the 1st cycle showed that overall, for all 3 combination pills, the probabilities significantly decreased from the 2nd to the 3rd cycle (P .05). Also examined was the probability that a side effect would occur in the 2nd or 3rd cycle if the user had not experienced such an effect in the 1st cycle. In each instance, the probabilities are significantly lower (P .05) than the corresponding probabilities where the symptom had been experienced in a previous cycle. These data support the contention that side effects experienced on inititation of oral contraceptives should not prohibit its continuation because the majority of symptoms will disappear as the patient becomes accustomed to the hormonal preparation.
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PMID:The probability of side effects with ovral, norinyl 1/50 and norlestrin. 16 Aug 60

A case report of subacute, reversible ischemic colitis associated with use of oral contraceptives (OCs) is reported. A 19-year-old woman was admitted to the hospital with chief complaints of abdominal cramps, nausea, vomiting, diarrhea, and rectal bleeding of 2 days' duration. Past medical history and family history were noncontributory. The patient was receiving no medication other than Norinyl 2 (2 mg of norethindrone and .1 mg of mestranol), which she had been taking for 6 months. 2 days before admission the patient had taken 100 mg of dimenhydrinate and 2 ExLax tablets (90 mg of phenolphthalein) for constipation. Colonic roentgenograms revealed impaired mesenteric circulation and bowel ischemia; OC-induced ischemic bowel disease was diagnosed. Patient symptoms subsided within 96 hours of discontinuing the OC and initiating supportive therapy (including intravenous fluid infusion, nasogastric suction, analgesics, and antiemetics). When a repeat barium enema was performed, it showed resolution of the ischemia. In a short review following the case report, these drugs were indicted in causation of colitis-like syndrome: amoxicillin, ampicillin, cephazolin, chloramphenicol, chlorpropamide, clindamycin, cloxacillin, cotrimoxasole, cyclophosphamide, digitalis, ergotamine tartrate, flucytosine, fluorouracil, gold salts, laxative and cathartic abuse, mercurous chloride, methyldopa, penicillin V, and tetracycline. Ischemic bowel disease secondary to OC use is a rare but important complication because of its significant morbidity and potential mortality, and because of the widespread use of the drugs. The case report emphasizes the need to consider the differential diagnosis of acute vascular insult with bowel ischemia when acute abdominal pain progressing to bloody diarrhea occurs in young women taking OCs.
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PMID:Oral contraceptive-induced ischemic bowel disease. 48 72

The efficacy and tolerance of the new oral cephalosporin cefaclor was tested in 61 patients treated for a variety of moderate to severe ENT infections which were not expected to undergo a spontaneous remission without antibacterial therapy. The most frequently isolated pathogens were streptococci and Staphylococcus aureus. The dosage consisted of 500 mg cefaclor three times daily, and the treatment lasted between 4 and 43 days (average 14 days). In 35 cases, some of whom had already been treated unsuccussfully with another antibiotic, the results were very good. In 22 patients locally applied medicaments or surgery contributed to the good result. In four patients an unequivocal evaluation was not possible or therapy was not successful. The frequently noted rapid response to treatment with cefaclor was impressive. No relapses were recorded. In pharmacokinetic studies a cefaclor concentration of 2.8 mcg/g was obtained in the tonsils 90 minutes after oral administration of 1000 mg. Clinical examinations in 61 patients and a complete range of laboratory tests in 47 patients did not reveal any case of allergic reaction. One patient only complained of nausea and diarrhoea. In two patients temporary low grade thrombopenia and thrombocytosis respectively were observed. In several patients a slight transitory rise in transaminases was seen. Cefaclor thus proved to be an effective and well-tolerated antibiotic. Its indications in the treatment of ENT infections are discussed.
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PMID:[Experience with cefaclor in the treatment of ear, nose and throat infections. Indications for cefaclor therapy (author's transl)]. 55 Oct 89

A new form of postcoital contraceptive therapy is described as more effective because of reduced incidence of nausea, vomiting, and breast tenderness. Other forms of emergency contraceptive pills (ECPs) are the "Yuzpe" method or high-dose contraceptives. The new method calls for administration of 3 200-mg tablets of danocrine (Danazol) within 72 hours of unprotected intercourse and a second dose 12 hours later. There are mixed reviews of the efficacy of danocrine and ECPs. In one comparative study of ECP and danocrine use, efficacy of danocrine was greater but not significantly so. Another study found danocrine so ineffective that the study was halted. ECP use would not end unintended pregnancies caused by method failure unless it was condom failure. Estimates of ECP use involve 75% of the 1.7 million women with user or method failure, all 1.9 million women with unintended pregnancies from nonuse of contraceptives, and some of the 1.6 million abortion users. An obstacle to ECP use is lack of knowledge due to lack of Food and Drug Administration approval of Ovral and Danazol and physician concern for legal liability. Another obstacle consists in the logistics of obtaining ECPs and the fear of side effects. Provision of ECP kits with 3-5 regimens in clinic or physician offices is proposed for women without contraindications. Anticipated objections are reported to be encouragement of contraceptive risk taking, the health risks of repeated use, restrictions in Title X programs, and the drug effect on fertilization. Another proposal is to sell ECPs as over the counter drugs or in vending machines and changing US contraceptive prescription laws. Objections to elimination of the physician prescription requirement might be an increase in use among women with contraindications and a decrease in regular checkups and Pap tests. The objections could be overcome with proper package labeling. Paternalism is not a sufficient justification for requiring prescription of contraceptives and medical visits. ECPs, in fact, are already available as low dose contraceptives such as Lo/Ovral, Nordette, Levlen, Triphasil, and Tri-Levlen when 4 pills are used. Instructions for ECP use are given.
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PMID:Emergency contraceptive pills: a simple proposal to reduce unintended pregnancies. 148 31

The performance of a low-dose triphasic oral contraceptive (OC) in the first four cycles of use was evaluated by 1,326 primary-care physicians and specialists across Canada in a phase-IV postmarketing trial. Data were available from 5,460 women who completed 19,756 cycles of use with Synphasic. The incidence of intermenstrual bleeding characteristically decreased over the four cycles to 10% in women who were first-time users of OCs, to 14% in women who had previously used OCs but had discontinued use until this trial, and to 16% in women who had switched from another OC to Synphasic. The women reported a low incidence of headache, nausea, weight gain, breast complaints, and acne while receiving Synphasic. The results demonstrate good endometrial control with Synphasic and a high level of patient acceptance.
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PMID:Synphasic tablets in Canadian practice: a phase-IV multicenter study. 186 41

From August 1988-June 1989, 983 physicians participated in a phase IV trial by following 7759 women using the monophasic oral contraceptive (OC), Demulen 1/35 (1 mg ethynodiol diacetate and 35 ug ethinyl estradiol) to evaluate its efficacy and safety. The total number of cycles for the study stood at 21,440. In addition, the total woman-years stood at 1787. Only 6382 patients could be evaluated for safety. 4.4% of the patients had adverse reactions to the OC, but only 1.7% of all patients stopped taking it. The leading side effects included nausea (67 cases), headache (45), amenorrhea (42), emotional changes (30), breast pain (19), dysmenorrhea (12), and 11 cases of weight gain, abdominal/pelvic pain, and bloating. Of the 280 reported adverse reactions, only 87 (31%) were considered severe. The leading serious adverse reactions were depression (10) and hypertension (6). Only 5412 patients could be used to determine efficacy. The physicians initially reported 121 (2.2%) pregnancies during the study. The researchers learned that 33 of the 84 returned 2nd questionnaires (response rate, 70%) reported that the women conceived after enrollment but before taking the OC. 36 conceived while taking it, but 8 did not take it daily. Noncompliance may have contributed to pregnancy for the remaining 28 cases. Therefore the 36 confirmed pregnancies made for a failure rate of .7%. 85.7% of the pregnancies happened in the 1st 3 months of taking the OC. Either patient noncompliance or true medication failure accounted for treatment failure. Therefore it is important for physicians to instruct patients on how to take OCs correctly.
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PMID:Efficacy and safety of ethynodiol diacetate, 1 mg, with ethinyl estradiol, 35 micrograms, with an emphasis on contraceptive efficacy. A phase IV trial. 204 81

A comparative clinical trial of two combined oral contraceptives differing only in estrogen type and dosage was conducted at the Centro de Investigaciones Hideyo Noguchi in Merida, Yucatan, Mexico. The trial was designed to determine the differences between Norinyl 1 + 50 (Syntex) and Norinyl 1 + 35 (Syntex) in rates of discontinuation and frequency of selected side-effects which might contribute to method discontinuation. Three hundred women were randomly assigned to either the Norinyl 1 + 35 group or to the Norinyl 1 + 50 group and follow-up visits were scheduled at 1, 4, 8 and 12 months after admission. In the Norinyl 1 + 35 group, more women experienced an increase in intermenstrual bleeding (primarily staining and spotting) (p less than 0.05), breast discomfort (p less than 0.05) and nausea than in the Norinyl 1 + 50 group. There was a significantly higher discontinuation rate for personal reasons, such as desired change of method and method not needed, among the women taking Norinyl 1 + 35 (p less than 0.05). The largest number of discontinuations comprised women discontinuing for menstrual problems in both groups. The life-table total discontinuation rate at 12 months was 52.0 for the Norinyl 1 + 35 group and 50.7 for the Norinyl 1 + 50 group. The lost-to-follow-up rates at 12 months were 17.8 for the Norinyl 1 + 35 group and 22.8 for the Norinyl 1 + 50 group.
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PMID:A comparative clinical trial of Norinyl 1 + 35 versus Norinyl 1 + 50 in Merida, Yucatan, Mexico. 220 18

An open, three-day trial was carried out in 49 infants and children with vomiting related to an acute gastrointestinal or ENT infection (63.3% of cases), a gastroesophageal reflux (20.4%), or an attack of malaria (14.3%). Mean age of patients was 21.9 months. Number of episodes of vomiting exceeded six per day in 89.8% of patients. Alizapride (Plitican) was given as oral drops in a dosage of 3 mg/kg/d. Five patients were prematurely withdrawn from the trial for clinical deterioration requiring discontinuation of enteral nutrition. Under treatment, vomiting resolved completely in 35 patients, i.e. 71.4% of the initial study group. Six patients exhibited incomplete improvement of vomiting and eight (including the 5 dropouts) continued to have a significant number of episodes of vomiting. Overall effectiveness evaluated on the frequency of episodes of vomiting, weight changes, and the investigator's clinical judgement was considered as excellent or good in 81.6% of cases. No significant adverse effects were recorded but the product's bitter taste was involved in the persistence of vomiting in one of the dropouts and in the development of moderate nausea in another patient who was able to continue treatment. The therapeutic value of alizapride, evaluated using an analog scale, proved significant in this indication.
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PMID:[The value of alizapride in the treatment of vomiting in infants and children]. 232 4

Japan began oral contraceptive (OC) clinical studies after 1987 when the government requested studies of 2400 menstrual cycles and a minimum of 100 patients for 12 cycles and 20-30 patients for 24 cycles. 3 monophasic, 1 biphasic, and 4 triphasic drugs were tested from 6 companies and all contained ethinyl estradiol with different progestins (norethindrone, levonorgestrel, or desogestrel). In phase I, the purpose was to examine the pharmacological effects and shortterm safety of all 8 drugs among a small number of healthy volunteers and a comparison of results with Western women. Phase II was eliminated. Phase III involved examination of toleration of the drug, dropout rate, effects on cycle control such as bleeding patterns, metabolism, and effects on hormone secretion. In phase I, Ortho Novum 7/7/7 was administered at 3 dose levels for 1 menstrual cycle and the results were toleration and minimal side effects. Some experienced bleeding, spotting, and breakthrough bleeding. Suppression of ovulation was successful. In phase III, 40 medical schools, 174 hospitals, and 200 investigators enrolled 648 patients of which 117 withdrew. Interim results among women 22-42 years show no adverse effects either in self- reports or laboratory tests. There were nuisance side effects such as nausea, weight gain, and headache, and some amenorrhea and bleeding during different cycles. There is a high continuation rate and patient satisfaction. Results from the full sample are still pending.
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PMID:The current status of oral contraceptive clinical development in Japan. 257 51

A brief review on how the combined oral contraceptive Ovral is used, without official US FDA approval, as a postcoital contraceptive is presented. The pill contains 50 mcg ethinyl estradiol and 0.5 mg norgestrel. Presumably the estrogen prevents implantation. The recommended dosage is 2 tablets taken 12 hours apart, preferably within 12-24 hours, and no later that 72 hours, after intercourse. Compared to a likelihood of pregnancy, in the event of unprotected intercourse, of 20% 3 days before ovulation, 25% 1 day before ovulation, and 15% on the day of ovulation, Ovral has been reported to prevent all by 1.8% of pregnancies. The highest failure rate cited was 7.4%. The only adverse effects noted were nausea, vomiting and breast tenderness. No fetal malformations have been published with this regimen.
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PMID:Ovral as a "morning-after" contraceptive. 279 42


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