Manufacturers' Warnings In Clinical States: Primary Pulmonary Hypertension: Anorexigens increase the risk of developing primary pulmonary hypertension, an often fatal disorder.
Although Duromine was not identified, an epidemiological study has indicated that use of other anorexigens for longer than 3 months was associated with a 23-fold increase in the risk of developing Primary Pulmonary Hypertension (PPH). There was no significant increase in risk for persons who had used these agents for 3 months or less. Obesity itself (body mass index ³30 kg/m was also independently associated with an increase of about two-fold in the risk of developing PPH. In the general population, the yearly occurrence of PPH is estimated to be about 1 to 2 cases per 1 000 000 persons. Therefore, the estimated risk associated with the long-term use of anorexigen drugs is about 23 to 46 cases per million persons exposed per year. The study further suggested that the risk of PPH rises with increasing duration of use of these drugs. The effect of intermittent compared to continuous use of anorexigens on the risk of PPH has not been determined.
The onset of aggravation of exertional dyspnea, or unexplained symptoms of angina pectoris, syncope, or lower extremity edema suggest the possibility of occurrence of pulmonary hypertension. Under these circumstances, treatment should be immediately discontinued, and the patient should be evaluated for the possible presence of PPH.
If tolerance to the anorectic effect develops, the recommended dose should not be exceeded in an attempt to increase the effect: rather, the drug should be discontinued.
Occupational Hazards: Duromine may impair the ability of the patient to engage in potentially hazardous activities such as operating machinery or driving a motor vehicle; the patient should, therefore, be cautioned accordingly.
When using CNS active agents, consideration must always be given to the possibility of adverse interactions with alcohol.
Drug Dependence: Duromine is related chemically and pharmacologically to amphetamine (d- and dl-amphetamine) and other stimulant drugs that have been extensively abused. The possibility of abuse of Duromine should be kept in mind when evaluating the desirability of including a drug as part of a weight reduction program. Abuse of amphetamine (d- and dl-amphetamine) and related drugs may be associated with intense psychological dependence and severe social dysfunction. There are reports of patients who have increased the dosage of some of these drugs to many times that recommended. Abrupt cessation following prolonged high dosage administration results in extreme fatigue and mental depression; changes are also noted on the sleep EEG. Manifestations of chronic intoxication with anorectic drugs include severe dermatoses, marked insomnia, irritability, hyperactivity and personality changes. The most severe manifestation of chronic intoxication is psychosis, often clinically indistinguishable from schizophrenia.
Pregnancy: Safe use in pregnancy has not been established. Use of Duromine by women who are or may become pregnant requires that the potential benefit be weighed against the possible hazard to mother and infant.
Children: Duromine is not recommended for use in children under 12 years of age.
Although Duromine was not identified, an epidemiological study has indicated that use of other anorexigens for longer than 3 months was associated with a 23-fold increase in the risk of developing Primary Pulmonary Hypertension (PPH). There was no significant increase in risk for persons who had used these agents for 3 months or less. Obesity itself (body mass index ³30 kg/m was also independently associated with an increase of about two-fold in the risk of developing PPH. In the general population, the yearly occurrence of PPH is estimated to be about 1 to 2 cases per 1 000 000 persons. Therefore, the estimated risk associated with the long-term use of anorexigen drugs is about 23 to 46 cases per million persons exposed per year. The study further suggested that the risk of PPH rises with increasing duration of use of these drugs. The effect of intermittent compared to continuous use of anorexigens on the risk of PPH has not been determined.
The onset of aggravation of exertional dyspnea, or unexplained symptoms of angina pectoris, syncope, or lower extremity edema suggest the possibility of occurrence of pulmonary hypertension. Under these circumstances, treatment should be immediately discontinued, and the patient should be evaluated for the possible presence of PPH.
If tolerance to the anorectic effect develops, the recommended dose should not be exceeded in an attempt to increase the effect: rather, the drug should be discontinued.
Occupational Hazards: Duromine may impair the ability of the patient to engage in potentially hazardous activities such as operating machinery or driving a motor vehicle; the patient should, therefore, be cautioned accordingly.
When using CNS active agents, consideration must always be given to the possibility of adverse interactions with alcohol.
Drug Dependence: Duromine is related chemically and pharmacologically to amphetamine (d- and dl-amphetamine) and other stimulant drugs that have been extensively abused. The possibility of abuse of Duromine should be kept in mind when evaluating the desirability of including a drug as part of a weight reduction program. Abuse of amphetamine (d- and dl-amphetamine) and related drugs may be associated with intense psychological dependence and severe social dysfunction. There are reports of patients who have increased the dosage of some of these drugs to many times that recommended. Abrupt cessation following prolonged high dosage administration results in extreme fatigue and mental depression; changes are also noted on the sleep EEG. Manifestations of chronic intoxication with anorectic drugs include severe dermatoses, marked insomnia, irritability, hyperactivity and personality changes. The most severe manifestation of chronic intoxication is psychosis, often clinically indistinguishable from schizophrenia.
Pregnancy: Safe use in pregnancy has not been established. Use of Duromine by women who are or may become pregnant requires that the potential benefit be weighed against the possible hazard to mother and infant.
Children: Duromine is not recommended for use in children under 12 years of age.
No comments:
Post a Comment