PRINCETON, N.J., and TOKYO, Dec.
12 /PRNewswire-FirstCall/ -- Bristol-Myers Squibb Company (NYSE: ) and Otsuka Pharmaceutical Co., Ltd. today announced the launch of ABILIFY(R) (aripiprazole) Injection, an injectable form of ABILIFY, for intramuscular use.
ABILIFY Injection mania at primary endpoint (2 hours). The U.S.
Food and Drug Administration (FDA) approved ABILIFY Injection on September 20, 2006. intervention. ABILIFY Injection provides healthcare professionals with the "Acute agitation can be very serious, distressing and potentially dangerous for patients, healthcare professionals and caregivers," said Medicine.
"ABILIFY Injection controls agitation independent of sedation." verbal activity, irritability, uncooperativeness, verbal outburst or abuse instructs that if ongoing ABILIFY therapy is clinically indicated, ABILIFY formulation of the same agent for long-term disease management. ABILIFY evaluated in three short-term (24-hour), randomized, double-blind, placebo- disorder (one study), manic or mixed, involving a total of 1,086 patients.
these studies using several scales, including the Positive and Negative of Improvement (CGI-I) scale. The primary efficacy measure used for the PANSS EC at two hours post-injection. PANSS EC includes five items: poor impulse control, tension, hostility, uncooperativeness and excitement.
than 0.05) in all three studies as measured using the PANSS EC. On the primary efficacy measure PANSS EC, the recommended dosage of 9.
75 mg of ABILIFY Injection was shown to be effective in controlling agitation. In two studies in agitated patients with schizophrenia, ABILIFY(R) (aripiprazole) Injection and Haldol(R) (haloperidol) intramuscular, a patients, were compared to placebo. These studies demonstrated that ABILIFY was superior to placebo.
Haldol intramuscular, the active comparator, was tablets, improvement was maintained. ABILIFY Injection and Ativan(R) (lorazepam) Injection, an antianxiety and sedative medication commonly used for the treatment of agitation, were Disorder (manic or mixed). In this study, ABILIFY Injection was superior to placebo.
Ativan Injection, the active comparator, was superior to placebo. three ABILIFY Injection trials, the safety profile was comparable to or dystonia. Non-akathisia related EPS adverse events were similar for the compared to 0% for placebo, while the incidence of dystonia with ABILIFY Injection was less than 1% compared to 0% for placebo.
In addition, the ABILIFY now has one of the broadest ranges of formulations (tablets, non- refrigerated oral solution, orally disintegrating tablets and The first and only available dopamine partial agonist, ABILIFY(R) observed for relapse during a period of up to 26 weeks. ABILIFY is also with Bipolar I Disorder, and for maintaining efficacy in adults with stabilized and then maintained for at least six (6) weeks. Physicians who the long-term usefulness of the drug for the individual.
Initially approved in November 2002, ABILIFY is the fastest-growing atypical antipsychotic in ABILIFY is available by prescription only. ABILIFY tablets are available in 2-, 5-, 10-, 15-, 20- and 30-mg strengths. The effective dose Tablets are available in 10 mg and 15 mg strengths.
In addition, ABILIFY is available in a 1 mg/mL nonrefrigerated oral solution. The safety of doses ABILIFY is taken once daily with or without food. It is important to medications, a rare and potentially fatal condition known as NMS has been reported with ABILIFY.
NMS can cause hyperpyrexia, muscle rigidity, diaphoresis, tachycardia, irregular pulse or blood pressure, cardiac dysrhythmia, and altered mental status. If signs and symptoms appear, immediate discontinuation is recommended and the total cumulative dose increase. Prescribing should be consistent with the need to minimize TD.
If signs and symptoms appear, discontinuation should be considered since TD may remit, partially or including fatalities, have been reported at an increased incidence in -- Hyperglycemia and diabetes mellitus -- Hyperglycemia, in some cases associated with ketoacidosis, coma, or death, has been reported in and periodic fasting blood glucose testing. Patients who develop testing. There have been few reports of hyperglycemia with ABILIFY used with caution in patients with known cardiovascular disease, cerebrovascular disease, or conditions which would predispose them to As with other antipsychotic drugs, ABILIFY should be used with caution Like other antipsychotics, ABILIFY may have the potential to impair judgment, thinking, or motor skills.
Patients should not drive or operate been attributed to antipsychotics. Appropriate care is advised for patients who may exercise strenuously, be exposed to extreme heat, receive concomitant medication with anticholinergic activity, or be subject to aspiration, ABILIFY should be used cautiously in patients at risk for illness and bipolar disorder, close supervision of high-risk patients should accompany drug therapy. Prescriptions for ABILIFY should be written become pregnant while taking ABILIFY.
Patients should be advised not to Both CYP3A4 and CYP2D6 are responsible for ABILIFY metabolism. Agents that induce CYP3A4 (eg, carbamazepine) could cause an increase in ABILIFY clearance and lower blood levels. Inhibitors of CYP3A4 (eg, ketoconazole) or CYP2D6 (eg, quinidine, fluoxetine, or paroxetine) can inhibit ABILIFY and at a rate at least twice the rate of placebo for ABILIFY vs placebo, About Bristol-Myers Squibb and Otsuka Pharmaceutical Co.
, Ltd. Bristol-Myers Squibb and Otsuka Pharmaceutical Co., Ltd.
are ABILIFY was discovered by Otsuka Pharmaceutical Co., Ltd. The brand name ABILIFY is registered to Otsuka Pharmaceutical Co.
, Ltd. Founded in 1964, Otsuka Pharmaceutical Co., Ltd.
is a healthcare company with the health worldwide." Otsuka researches, develops, manufactures and markets innovative, original products, focusing its core businesses on for the maintenance of everyday health. The Otsuka Pharmaceutical Group comprises 87 companies and employs approximately 27,000 people in 17 countries and regions worldwide.
Otsuka and its consolidated subsidiaries For more information and FULL PRESCRIBING INFORMATION, Visit Otsuka Pharmaceutical Co., Ltd.
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