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Products - CNS
Azur Pharma's CNS portfolio comprises of FazaClo®, Prialt®, Niravam®, and Parcopa®.
FazaClo® (clozapine, USP) is a unique orally disintegrating tablet formulation of clozapine. FazaClo® is an antipsychotic drug indicated for the management of severely ill schizophrenic patients who fail to respond to standard treatments. FazaClo® also is indicated for reduction in the risk of recurrent suicidal behaviour in schizophrenia or schizoaffective disorders. FazaClo® is supported by a national sales infrastructure as well as a field-based team of Clinical Compliance Liaisons. In addition, FazaClo® has a patient registry team, who provide 24/7 assistance to healthcare professionals and patients.
Prialt® (ziconotide intrathecal infusion) is indicated for the management of severe chronic pain in patients for whom intrathecal (IT) therapy is warranted, and who are intolerant of or refractory to other treatment, such as systemic analgesics, adjunctive therapies or IT morphine. Prialt® is for use only in the Medtronic SynchroMed® EL, Synchromed® II Infusion System and the CADD-Micro ambulatory infusion pump.
Niravam® is an orally disintegrating tablet formulation of alprazolam. Niravam® is used in the treatment of anxiety and panic disorder.
Parcopa® is an orally disintegrating tablet formulation of carbidopa-levodopa. Parcopa® is used in the treatment of Parkinson's disease.
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FazaClo is an antipsychotic drug indicated for the management of severely ill schizophrenic patients who fail to respond to standard treatments. FazaClo also is indicated for reduction in the risk of recurrent suicidal behaviour in schizophrenia or schizoaffective disorders. |
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For further information on FazaClo,
BOXED WARNINGS: Due to the risk of agranulocytosis, a potentially life-threatening adverse event, clozapine should be reserved for (1) severely ill patients with schizophrenia who fail to respond adequately to standard drug treatment, or (2) patients with schizophrenia or schizoaffective disorder at risk of recurrent suicidal behaviour. Patients being treated with clozapine must have their blood tested for a baseline white blood cell (WBC) count and absolute neutrophil count (ANC) before initiation of treatment, and have regular WBC counts and ANCs during treatment and for at least 4 weeks after discontinuation of treatment. Analyses of post-marketing safety databases suggest that clozapine is associated with an increased risk of fatal myocarditis, especially during the first month of therapy. In patients in whom myocarditis is suspected, clozapine treatment should be promptly discontinued. Seizures have been associated with clozapine, with a greater likelihood at higher doses. Orthostatic hypotension, a rapid drop in blood pressure that makes you feel faint or dizzy, with or without collapse, can occur with clozapine treatment. Rarely, collapse can be profound and be accompanied by respiratory and/or cardiac arrest. Orthostatic hypotension is more likely to occur during initial dosing, in association with a rapid dose escalation. Elderly patients with dementia-related psychosis treated with atypical antipsychotic drugs are at an increased risk of death compared to placebo. FazaClo is not approved for the treatment of those patients. Please see package insert for full prescribing information, including side effects, warnings, and drug interactions. |
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Prialt® (ziconotide intrathecal infusion) is a different type of calcium channel blocker. Results in animal model studies suggest that Prialt® exerts its antinociceptive effect(s) by selectively blocking the presynaptic N-type calcium channels and reducing the release of excitatory neurotransmitters from the primary afferent nerve terminals. The mechanism of action has not been established in humans; however, this unique mechanism of action gives physicians a different option when treating severe chronic pain. Prialt® does not bind to opioid receptors. Prialt® does not potentiate opiate-induced respiratory depression. Because Prialt® is not an opiate, it cannot prevent or relieve the symptoms associated with opiate withdrawal. |
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For further information on Prialt®,
WARNINGS: Severe psychiatric symptoms and neurological impairment may occur during treatment with Prialt®. Patients with a pre-existing history of psychosis should not be treated with Prialt®. All patients should be monitored frequently for evidence of cognitive impairment, hallucinations, or changes in mood or consciousness. Prialt® therapy can be interrupted or discontinued abruptly without evidence of withdrawal effects in the event of serious neurological or psychiatric signs or symptoms. |
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Niravam® is an orally administered formulation of alprazolam which rapidly disintegrates on the tongue and does not require water to aid dissolution or swallowing. Niravam® is indicated for the management of anxiety disorder or the short-term relief of symptoms of anxiety. Niravam® is also indicated for the treatment of panic disorder, with or without agoraphobia. |
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Parcopa® is an orally administered formulation of carbidopa-levodopa which rapidly disintegrates on the tongue and does not require water to aid dissolution or swallowing. Parcopa® is indicated in the treatment of the symptoms of idiopathic Parkinson's disease (paralysis agitans), post-encephalitic parkinsonism, and symptomatic parkinsonism which may follow injury to the nervous system by carbon monoxide intoxication and/or manganese intoxication. |
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