Kombiglyze Xr

Kombiglyze Xr

Kombiglyze Xr Recall

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Questions & Answers

副作用和不良反应

Serious Cardiovascular Events
猝死和先前存在的结构心脏异常或其他严重的心脏问题:
Children and Adolescents:

猝死与报道CNS stimulant treatment at usual doses in children and adolescents with structural cardiac abnormalities or other serious heart problems. Although some structural heart problems alone may carry an increased risk of sudden death, stimulant products generally should not be used in children or adolescents with known structural cardiac abnormalities, cardiomyopathy, serious heart rhythm abnormalities, or other serious cardiac problems that may place them at increased vulnerability to the sympathomimetic effects of a stimulant drug (seeCONTRAINDICATIONS)。

成年人:

Sudden deaths, stroke, and myocardial infarction have been reported in adults taking stimulant drugs at usual doses for ADHD. Although the role of stimulants in these adult cases is also unknown, adults have a greater likelihood than children of having serious structural cardiac abnormalities, cardiomyopathy, serious heart rhythm abnormalities, coronary artery disease, or other serious cardiac problems. Adults with such abnormalities should also generally not be treated with stimulant drugs (seeCONTRAINDICATIONS)。

Hypertension and Other Cardiovascular Conditions:

Stimulant medications cause a modest increase in average blood pressure (about 2 mmHg to 4 mmHg) and average heart rate (about 3 bpm to 6 bpm) [seeADVERSE REACTIONS], and individuals may have larger increases. While the mean changes alone would not be expected to have short-term consequences, all patients should be monitored for larger changes in heart rate and blood pressure. Caution is indicated in treating patients whose underlying medical conditions might be compromised by increases in blood pressure or heart rate, e.g., those with preexisting hypertension, heart failure, recent myocardial infarction, or ventricular arrhythmia (seeCONTRAINDICATIONS)。

Assessing Cardiovascular Status in Patients Being Treated With Stimulant Medications:

Children, adolescents or adults who are being considered for treatment with stimulant medications should have a careful history (including assessment for a family history of sudden death or ventricular arrhythmia) and physical exam to assess for the presence of cardiac disease and should receive further cardiac evaluation if findings suggest such disease, (e.g., electrocardiogram and echocardiogram). Patients who develop symptoms such as exertional chest pain, unexplained syncope, or other symptoms suggestive of cardiac disease, during stimulant treatment should undergo a prompt cardiac evaluation.

Psychiatric Adverse Events
Preexisting Psychosis:

兴奋剂的给药可能加剧精神病患者的行为障碍和思想障碍的症状。

Bipolar Illness:

Particular care should be taken in using stimulants to treat ADHD patients with comorbid bipolar disorder because of concern for possible induction of mixed/manic episode in such patients. Prior to initiating treatment with a stimulant, patients with comorbid depressive symptoms should be adequately screened to determine if they are at risk for bipolar disorder; such screening should include a detailed psychiatric history, including a family history of suicide, bipolar disorder, and depression.

新的精神病或躁狂症状的出现:

Treatment emergent psychotic or manic symptoms, e.g., hallucinations, delusional thinking, or mania in children and adolescents without prior history of psychotic illness or mania can be caused by stimulants at usual doses. If such symptoms occur, consideration should be given to a possible causal role of the stimulant, and discontinuation of treatment may be appropriate. In a pooled analysis of multiple short-term, placebo-controlled studies, such symptoms occurred in about 0.1% (4 patients with events out of 3,482 exposed to methylphenidate or amphetamine for several weeks at usual doses) of stimulant-treated patients compared to 0 in placebo-treated patients.

Aggression:

Aggressive behavior or hostility is often observed in children and adolescents with ADHD, and has been reported in clinical trials and the postmarketing experience of some medications indicated for the treatment of ADHD. Although there is no systematic evidence that stimulants cause aggressive behavior or hostility, patients beginning treatment for ADHD should be monitored for the appearance of or worsening of aggressive behavior or hostility.

Long-Term Suppression of Growth:

Careful follow-up of weight and height in children ages 7 to 10 years who were randomized to either methylphenidate or non-medication treatment groups over 14 months, as well as in naturalistic subgroups of newly methylphenidate-treated and non-medication treated children over 36 months (to the ages of 10 to 13 years), suggests that consistently medicated children (i.e., treatment for 7 days per week throughout the year) have a temporary slowing in growth rate (on average, a total of about 2 cm less growth in height and 2.7 kg less growth in weight over 3 years), without evidence of growth rebound during this period of development.

Published data are inadequate to determine whether chronic use of amphetamines may cause a similar suppression of growth, however, it is anticipated that they will likely have this effect as well. Therefore, growth should be monitored during treatment with stimulants, and patients who are not growing or gaining weight as expected may need to have their treatment interrupted.

癫痫发作:

There is some clinical evidence that stimulants may lower the convulsive threshold in patients with prior history of seizure, in patients with prior EEG abnormalities in absence of seizures, and very rarely, in patients without a history of seizures and no prior EEG evidence of seizures. In the presence of seizures, the drug should be discontinued.

Peripheral Vasculopathy, Including Raynaud’s Phenomenon:

用于治疗ADHD的刺激剂,包括右旋苯丙胺糖,苯丙胺天冬氨酸,右旋苯丙胺硫酸盐和二苯丙胺硫酸盐片,与包括Raynaud的现象有关。体征和症状通常是间歇性和温和的;但是,非常罕见的后遗症包括数字溃疡和/或软组织破裂。在整个治疗过程中,在不同时间和所有年龄段的治疗剂量的市场报告中都观察到外周外周血管病的影响,包括雷诺现象。药物剂量或停用后,症状和症状通常会改善。在使用ADHD兴奋剂治疗期间,必须仔细观察数字变化。进一步的临床评估(例如,风湿病转诊)可能适合某些患者。

法律问题

There is currently no legal information available for this drug.

FDA安全警报

目前,该药物没有FDA安全警报。

Manufacturer Warnings

目前还没有生产informa的警告tion available for this drug.

FDA Labeling Changes

There are currently no FDA labeling changes available for this drug.

Uses

右旋苯丙胺糖,苯丙胺天冬氨酸一水合物,右旋苯丙胺硫酸盐和二苯丙胺硫酸盐片,用于治疗注意力缺陷多症多动障碍(ADHD)和Narcolepsy。

Attention Deficit Hyperactivity Disorder (ADHD)

注意力缺陷多动障碍(ADHD; DSM-IV®)的诊断意味着存在导致损害并在7岁之前出现的过度活跃的冲动或注意力不集中症状。这些症状必须在社会,学术或职业功能中引起临床上的显着障碍,并在两个或多个环境中存在,例如学校(或工作)和家里。另一种精神障碍不得更好地解释症状。对于不专心的类型,至少六个症状必须持续至少6个月:缺乏对细节/粗心的错误的关注;缺乏持续的关注;可怜的听众;未能遵循任务;组织差;避免需要持续精神努力的任务;失去东西; easily distracted; forgetful. For the Hyperactive-Impulsive Type, at least six of the following symptoms must have persisted for at least 6 months: fidgeting/squirming; leaving seat; inappropriate running/climbing; difficulty with quiet activities; "on the go;" excessive talking; blurting answers; can't wait turn; intrusive. The Combined Type requires both inattentive and hyperactive-impulsive criteria to be met.

Special Diagnostic Considerations

特定的这种综合征的病因尚不清楚,there is no single diagnostic test. Adequate diagnosis requires the use not only of medical but of special psychological, educational, and social resources. Learning may or may not be impaired. The diagnosis must be based upon a complete history and evaluation of the child and not solely on the presence of the required number of DSM-IV® characteristics.

Need for Comprehensive Treatment Program

Dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate and amphetamine sulfate tablets are indicated as an integral part of a total treatment program for ADHD that may include other measures (psychological, educational, social) for patients with this syndrome. Drug treatment may not be indicated for all children with this syndrome. Stimulants are not intended for use in the child who exhibits symptoms secondary to environmental factors and/or other primary psychiatric disorders, including psychosis. Appropriate educational placement is essential and psychosocial intervention is often helpful. When remedial measures alone are insufficient, the decision to prescribe stimulant medication will depend upon the physician's assessment of the chronicity and severity of the child's symptoms.

Long-Term Use

The effectiveness of dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate and amphetamine sulfate tablets for long-term use has not been systematically evaluated in controlled trials. Therefore, the physician who elects to use dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate and amphetamine sulfate tablets for extended periods should periodically re-evaluate the long-term usefulness of the drug for the individual patient.

History

There is currently no drug history available for this drug.

Other Information

A single-entity amphetamine product combining the neutral sulfate salts of dextroamphetamine and amphetamine, with the dextro isomer of amphetamine saccharate and d, l-amphetamine aspartate monohydrate.

The structural formula is:
右旋智能结构公式

C9H13N MW=135.21

Each Tablet Contains

5 mg

10 mg

20 mg

30 mg

Dextroamphetamine Saccharate

1.25 mg

2.5 mg

5 mg

7.5 mg

Amphetamine Aspartate Monohydrate

1.25 mg

2.5 mg

5 mg

7.5 mg

Dextroamphetamine Sulfate USP

1.25 mg

2.5 mg

5 mg

7.5 mg

Amphetamine Sulfate USP

1.25 mg

2.5 mg

5 mg

7.5 mg

Total amphetamine base equivalence

3.13 mg

6.3 mg

12.6 mg

18.8 mg

In addition each tablet for oral administration contains the following inactive ingredients: lactose monohydrate, pregelatinized starch (corn) and magnesium stearate.

In addition the 5 mg and 10 mg tablets contain FD&C blue No. 1 aluminum lake and the 20 mg and 30 mg tablets contain FD&C yellow No. 6 aluminum lake as color additives.

Kombiglyze Xr Manufacturers


  • Astrazeneca Pharmaceuticals Lp
    Kombiglyze Xr (Saxagliptin And Metformin Hydrochloride) Tablet, Film Coated, Extended Release [Astrazeneca Pharmaceuticals Lp]
  • E.r. Squibb & Sons, L.l.c.
    Kombiglyze Xr (Saxagliptin And Metformin Hydrochloride) Tablet, Film Coated, Extended Release [E.r. Squibb & Sons, L.l.c.]

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