G. Ramon. Eastern Nazarene College.
Patients Receiving Sulfonylureas or Insulin: Sulfonylurea agents or insulin may cause hypoglycemia discount 200mcg cytotec symptoms 5 days after conception. Precose given in combination with a sulfonylurea or insulin may cause a further lowering of blood glucose and may increase the potential for hypoglycemia purchase cytotec 200 mcg otc medicine ball workouts. If hypoglycemia occurs, appropriate adjustments in the dosage of these agents should be made. Very rarely, individual cases of hypoglycemic shock have been reported in patients receiving Precose therapy in combination with sulfonylureas and/or insulin. Precose has been shown to change the bioavailability of digoxin when they are coadministered, which may require digoxin dose adjustment. Eight carcinogenicity studies were conducted with acarbose. Six studies were performed in rats (two strains, Sprague-Dawley and Wistar) and two studies were performed in hamsters. In the first rat study, Sprague-Dawley rats received acarbose in feed at high doses (up to approximately 500 mg/kg body weight) for 104 weeks. Acarbose treatment resulted in a significant increase in the incidence of renal tumors (adenomas and adenocarcinomas) and benign Leydig cell tumors. Further studies were performed to separate direct carcinogenic effects of acarbose from indirect effects resulting from the carbohydrate malnutrition induced by the large doses of acarbose employed in the studies. In one study using Sprague-Dawley rats, acarbose was mixed with feed but carbohydrate deprivation was prevented by the addition of glucose to the diet. In a 26-month study of Sprague-Dawley rats, acarbose was administered by daily postprandial gavage so as to avoid the pharmacologic effects of the drug. In both of these studies, the increased incidence of renal tumors found in the original studies did not occur. Acarbose was also given in food and by postprandial gavage in two separate studies in Wistar rats. No increased incidence of renal tumors was found in either of these Wistar rat studies. In two feeding studies of hamsters, with and without glucose supplementation, there was also no evidence of carcinogenicity. Acarbose did not induce any DNA damage in vitro in the CHO chromosomal aberration assay, bacterial mutagenesis (Ames) assay, or a DNA binding assay. In vivo, no DNA damage was detected in the dominant lethal test in male mice, or the mouse micronucleus test. Fertility studies conducted in rats after oral administration produced no untoward effect on fertility or on the overall capability to reproduce. The safety of Precose in pregnant women has not been established. Reproduction studies have been performed in rats at doses up to 480 mg/kg (corresponding to 9 times the exposure in humans, based on drug blood levels) and have revealed no evidence of impaired fertility or harm to the fetus due to acarbose. In rabbits, reduced maternal body weight gain, probably the result of the pharmacodynamic activity of high doses of acarbose in the intestines, may have been responsible for a slight increase in the number of embryonic losses. However, rabbits given 160 mg/kg acarbose (corresponding to 10 times the dose in man, based on body surface area) showed no evidence of embryotoxicity and there was no evidence of teratogenicity at a dose 32 times the dose in man (based on body surface area). There are, however, no adequate and well-controlled studies of Precose in pregnant women. Because animal reproduction studies are not always predictive of the human response, this drug should be used during pregnancy only if clearly needed. Because current information strongly suggests that abnormal blood glucose levels during pregnancy are associated with a higher incidence of congenital anomalies as well as increased neonatal morbidity and mortality, most experts recommend that insulin be used during pregnancy to maintain blood glucose levels as close to normal as possible. Nursing Mothers: A small amount of radioactivity has been found in the milk of lactating rats after administration of radiolabeled acarbose. It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, Precoseshould not be administered to a nursing woman. Pediatric Use: Safety and effectiveness of Precose in pediatric patients have not been established. Geriatric Use: Of the total number of subjects in clinical studies of Precose in the United States, 27 percent were 65 and over, while 4 percent were 75 and over. No overall differences in safety and effectiveness were observed between these subjects and younger subjects. The mean steady-state area under the curve (AUC) and maximum concentrations of acarbose were approximately 1. Digestive Tract: Gastrointestinal symptoms are the most common reactions to Precose. In a one-year safety study, during which patients kept diaries of gastrointestinal symptoms, abdominal pain and diarrhea tended to return to pretreatment levels over time, and the frequency and intensity of flatulence tended to abate with time. The increased gastrointestinal tract symptoms in patients treated with Precose are a manifestation of the mechanism of action of Precose and are related to the presence of undigested carbohydrate in the lower GI tract. If the prescribed diet is not observed, the intestinal side effects may be intensified. If strongly distressing symptoms develop in spite of adherence to the diabetic diet prescribed, the doctor must be consulted and the dose temporarily or permanently reduced. Elevated Serum Transaminase Levels: See PRECAUTIONS. Other Abnormal Laboratory Findings: Small reductions in hematocrit occurred more often in Precose-treated patients than in placebo-treated patients but were not associated with reductions in hemoglobin. Low serum calcium and low plasma vitamin B6 levels were associated with Precose therapy but are thought to be either spurious or of no clinical significance. Post Marketing Adverse Event Reports:Additional adverse events reported from worldwide post marketing experience include hypersensitive skin reactions (e. An overdose may result in transient increases in flatulence, diarrhea, and abdominal discomfort which shortly subside. In cases of overdosage the patient should not be given drinks or meals containing carbohydrates (polysaccharides, oligosaccharides and disaccharidees) for the next 4-6 hours. There is no fixed dosage regimen for the management of diabetes mellitus with Precose or any other pharmacologic agent. Dosage of Precose must be individualized on the basis of both effectiveness and tolerance while not exceeding the maximum recommended dose of 100 mg t. Precose should be taken three times daily at the start (with the first bite) of each main meal. Precose should be started at a low dose, with gradual dose escalation as described below, both to reduce gastrointestinal side effects and to permit identification of the minimum dose required for adequate glycemic control of the patient.
Because recombinant human insulin is identical to endogenous insulin discount 200mcg cytotec fast delivery symptoms gout, the systemic distribution and elimination are expected to be the same discount cytotec 200mcg with amex treatment 5 shaving lotion. Exubera, like subcutaneously administered rapid-acting insulin analogs, has a more rapid onset of glucose-lowering activity than subcutaneously administered regular human insulin. In healthy volunteers, the duration of glucose-lowering activity for Exubera was comparable to subcutaneously administered regular human insulin and longer than subcutaneously administered rapid-acting insulin analogs (see Figure 2). Mean Glucose Infusion Rate (GIR) Normalized to GIRfor Each Subject Treatment Versus Time in Healthy VolunteersWhen Exubera is inhaled, the onset of glucose-lowering activity in healthy volunteers occurs within 10-20 minutes. The maximum effect on glucose lowering is exerted approximately 2 hours after inhalation. The duration of glucose-lowering activity is approximately 6 hours. In patients with type 1 or type 2 diabetes, Exubera has a greater glucose-lowering effect within the first two hours after dosing when compared with subcutaneously administered regular human insulin. The intra-subject variability of glucose-lowering activity of Exubera is generally comparable to that of subcutaneously administered regular human insulin in patients with type 1 and 2 diabetes. In children (6-11 years) and adolescents (12-17 years) with type 1 diabetes, time to peak insulin concentration for Exubera was achieved faster than for subcutaneous regular human insulin, which is consistent with observations in adult patients with type 1 diabetes. There are no apparent differences in the pharmacokinetic properties of Exubera when comparing patients over the age of 65 years and younger adult patients. In subjects with and without diabetes, no apparent differences in the pharmacokinetic properties of Exubera were observed between men and women. A study was performed in 25 healthy Caucasian and Japanese non-diabetic subjects to compare the pharmacokinetic and pharmacodynamic properties of Exubera, versus subcutaneous injection of regular human insulin. The pharmacokinetic and pharmacodynamic properties of Exubera were comparable between the two populations. The absorption of Exubera is independent of patient BMI. The effect of renal impairment on the pharmacokinetics of Exubera has not been studied. Careful glucose monitoring and dose adjustments of insulin may be necessary in patients with renal dysfunction (see PRECAUTIONS, Renal Impairment). The effect of hepatic impairment on the pharmacokinetics of Exubera has not been studied. Careful glucose monitoring and dose adjustments of insulin may be necessary in patients with hepatic dysfunction (see PRECAUTIONS ). The absorption of Exubera in pregnant patients with gestational and pre-gestational type 2 diabetes was consistent with that in non-pregnant patients with type 2 diabetes (see PRECAUTIONS ). In smokers, the systemic insulin exposure for Exubera is expected to be 2 to 5 fold higher than in non-smokers. Exubera is contraindicated in patients who smoke or who have discontinued smoking less than 6 months prior to starting Exubera therapy. If a patient starts or resumes smoking, Exubera must be discontinued immediately due to the increased risk of hypoglycemia, and an alternative treatment must be utilized (see CONTRAINDICATIONS ). In clinical studies of Exubera in 123 patients (69 of whom were smokers), smokers experienced a more rapid onset of glucose-lowering action, greater maximum effect, and a greater total glucose-lowering effect (particularly during the first 2-3 hours after dosing), compared to non-smokers. In contrast to the increase in insulin exposure following active smoking, when Exubera was administered to 30 healthy non-smoking volunteers following 2 hours of exposure to passive cigarette smoke in a controlled experimental setting, insulin AUC and Cmax were reduced by approximately 20% and 30%, respectively. The pharmacokinetics of Exubera have not been studied in nonsmokers who are chronically exposed to passive cigarette smoke. Patients with Underlying Lung DiseasesThe use of Exubera in patients with underlying lung disease, such as asthma or COPD, is not recommended because the safety and efficacy of Exubera in this population have not been established (see WARNINGS ). The use of Exubera is contraindicated in patients with unstable or poorly controlled lung disease, because of wide variations in lung function that could affect the absorption of Exubera and increase the risk of hypoglycemia or hyperglycemia (see CONTRAINDICATIONS ). In a pharmacokinetic study in 24 non-diabetic subjects with mild asthma, the absorption of insulin following administration of Exubera, in the absence of treatment with a bronchodilator, was approximately 20% lower than the absorption seen in subjects without asthma. However, in a study in 24 non-diabetic subjects with Chronic Obstructive Pulmonary Disease (COPD), the systemic exposure following administration of Exubera was approximately two-fold higher than that in normal subjects without COPD (see PRECAUTIONS ). Administration of albuterol 30 minutes prior to administration of Exubera in non-diabetic subjects with both mild asthma (n=36) and moderate asthma (n=31) resulted in a mean increase in insulin AUC and Cmax of between 25 and 50% compared to when Exubera was administered alone (see PRECAUTIONS ). The safety and efficacy of Exubera has been studied in approximately 2500 adult patients with type 1 and type 2 diabetes. The primary efficacy parameter for most studies was glycemic control, as measured by the reduction from baseline in hemoglobin A1c (HbA1c). A 24-week, randomized, open-label, active-control study (Study A) was conducted in patients with type 1 diabetes to assess the safety and efficacy of Exubera administered pre-meal three times daily (TID) with a single nighttime injection of Humulin? U Ultralente? (human insulin extended zinc suspension) (n = 136). The comparator treatment was subcutaneous regular human insulin administered twice daily (BID) (pre-breakfast and pre-dinner) with BID injection of NPH human insulin (human insulin isophane suspension) (n = 132). A second 24-week, randomized, open-label, active-control study (Study B) was conducted in patients with type 1 diabetes to assess the safety and efficacy of Exubera (n = 103) compared to subcutaneous regular human insulin (n = 103) when administered TID prior to meals. In both treatment arms, NPH human insulin was administered BID (in the morning and at bedtime) as the basal insulin. In each study, the reduction in HbA1c and the rates of hypoglycemia were comparable for the two treatment groups. Exubera-treated patients had a greater reduction in fasting plasma glucose than patients in the comparator group. The percentage of patients reaching an HbA1c level of; SC R = subcutaneous regular human insulin* A negative treatment difference favors Exubera?-P American Diabetes Association treatment Action Level at the time of study conductc 1 mg inhaled insulin from Exubera is approximately equivalent to 3 IU of subcutaneously injected regular human insulin (See DOSAGE AND ADMINISTRATION )Adj. The proportion of patients treated with Exubera reaching an end-of-study HbAExubera monotherapy and Exubera in combination with OA therapy were superior to OA therapy alone in reducing HbAlevels from baseline. The rates of hypoglycemia for the two Exubera treatment groups were slightly higher than in the OA therapy alone group. Compared to OA therapy alone, the percentage of patients reaching an HbA* OAs = treatment with two oral agents (an insulin secretagogue in addition to metformin or a thiazolidinedione)?-P A negative treatment difference favors Exuberac Comparison of Exubera monotherapy to combination oral agent therapy alonef Comparison of Exubera plus oral agents to combination oral agent therapy alone# American Diabetes Association treatment Action Level at the time of study conductExubera group minus OAs ?-PA 24-week, randomized, open-label, active-control study (Study E) was conducted in patients with type 2 diabetes, currently receiving sulfonylurea therapy. This study was designed to assess the safety and efficacy of the addition of pre-meal Exubera to continued sulfonylurea therapy (n = 214) compared to the addition of pre-meal metformin to continued sulfonylurea therapy (n = 196). Subjects were stratified according to their HbA1c at Week -1. Two strata were defined: a low HbA1c stratum (HbAExubera in combination with sulfonylurea was superior to metformin and sulfonylurea in reducing HbA1c values from baseline in the high stratum group. Exubera in combination with sulfonylurea was comparable to metformin in combination with sulfonylurea in reducing HbA1c values from baseline in the low stratum group. The rate of hypoglycemia was higher after the addition of Exubera to sulfonylurea than after the addition of metformin to sulfonylurea. The percentage of patients reaching target HbA1c values of 8% and 7% was comparable between treatment groups in both strata, as was reduction in fasting plasma glucose (see Table 4).
There are cultural and other influences buy discount cytotec 100 mcg on-line medicine reactions, not just the family discount cytotec 100 mcg with visa medications affected by grapefruit. TV, peer groups, and the fashion industry are factors also. Usually there is some element of self-esteem, when a person meets cultural expectations and ideal body types and some sense of dissatisfaction with the self. Judith Asner: latlat, I think the parents need to get support or the parent will get very depressed. I suggest support groups for parents with eating disordered children. By going to a support group, the parents will typically get some distance from the illness that will allow the teenager to get some treatment eventually. I think the parents need to first get help for themselves. You can only go to treatment for yourself and then hopefully the teenager will become curious with the process and want to join in. Now if the eating disorder, bulimia or anorexia, becomes life-threatening, a parent can force the teenager into treatment. And, of course, they are scared and want to take immediate action. Judith, what do you think about a parent who tries to FORCE their child into treatment? A teenager is a child, so they need to be treated differently. I think you can appeal to their intellect and you can talk to them and have an interchange. An intervention is a loving event, not a punitive one. But if things get worse, or you change your mind, we are here to support you and you can start treatment then. My therapist considers it a form of self-harm, but I just see it as a way to get thin again. Maybe working carefully with a registered dietitian can help you lose weight without purging. I was one of ten children and my parents did the best they could. Yet I hid the bulimia for a long time; I was so ashamed of having such a gross coping mechanism. I have always been afraid of my older siblings and of not being perfect. I have been in recovery a long time but recently relapsed. I am a grown woman with a happy marriage and 2 babies that I had thought I might not be able to have because of the damage done in my teens and twenties. I mean, is there anyone special to go to and how do you start out the conversation with the person? Judith Asner: Willy, you should find out who specializes in treating eating disorders. If you go to my website, in my last newsletter, there are some resources that can help you find an eating disorders treatment specialist in your area. Chances are the eating disorders treatment specialist has had anorexia or bulimia too. David: One thing you can do is call the local psychological association and get a referral in your community. You can also call your family doctor or a local psychiatric center for a referral. Very often, therapy will address underlying issues and there will still be residual eating disorders that have not gone into remission. I have tried almost every known antidepressant (and many other types of prescription drugs) and am still very actively bulimic. I understand the use of a food journal to control the amount of food intake and educate one on their level of hunger. But what does one do when they have outlived the patience of their families and everyone else? Judith Asner: How about going to daily meetings of Overeaters Anonymous or eating disorders support groups that deal with bulimia specifically? Also, there is information in the Eating Disorders Community. Monica2000: What are we supposed to do when people think our ED is for attention. What are we to do if we get really depressed and just want to purge more? Stay away from any negative people as much as you can and be around supportive people. David: Apparently, some of the things being said today have struck a chord with the audience. Here are some comments: florecita: My stepmom cooks a lot of food all the time; pork and those kinds of meals. I tried to tell my parents, but I had to think of a cover story when she was far from happy. Most of the time I like the attention my friends and family are giving me. If they really want to help, they need to educate themselves about this disease. Granted, they many not want to because it may be hard. Parents may not understand why the sufferer is doing this to themselves. I like the attention it gets me, my friends and family show me they caremargnh: Planning makes you think about the food all the time, as with the journal. Eating Disorders tend to feed the negative self-concept. My disorder was "based on" fear of abandonment and the need to please. AmyGIRL: Can bulimia cause you to have a violent temper? Judith Asner: It can certainly be upsetting and make you feel out of control, angry with yourself and others.