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FANAPT TITRATION PACK TAB 8 by Vanda Pharma

NDC 00078-0602-08 UPC/GTIN No.3-00780-60208-2 Mfg.Part No.60208Vanda Pharmaceuticals Inc.This Item Can Only Be Ordered By A Drug Mfg, Wholesaler,Pharmacy,Physician, Dentist, Podiatrist, Optometrist,Veterinarian,Naturopath,Licensed Lab, Physical Therapist & Pharmacist(scope).Vanda Pharmaceuticals Inc.Image 4 of FANAPT TITRATION PACK TAB 8 by Vanda Pharma

FANAPT TITRATION PACK TAB 8 by Vanda Pharma

$203.61$179.99

NDC No. NEW 43068-0113-04 43068-113-04 00078-0602-08 UPC/GTIN No. NEW 3-43068-11304-7 3-00780-60208-2 MPN 60208 Only Physician,Pharmacy or Licensed Facility can order this Rx Item No. Rx075270 Fanapt 1/2/4/6mg Tab 8 by Vanda Pharma. Item No. 075270 NDC No. NEW 43068011304 4306811304 00078060208 UPC No. NEW 343068-113047 343068113047 300780602082 Other Name Fanapt, iloperidone Therapeutic Class Atypical Antipsychotics Item Class Non Controlled Rx. Case Qnty: 10 Atypical Antipsychotics Inf

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FANAPT- iloperidone tablet
FANAPT- iloperidone
Novartis Pharmaceuticals Corporation

WARNING: INCREASED MORTALITY IN ELDERLY PATIENTS WITH DEMENTIA-RELATED PSYCHOSIS

Elderly patients with dementia-related psychosis treated with antipsychotic drugs are at an increased risk of death. Analysis of seventeen placebo-controlled trials (modal duration 10 weeks), largely in patients taking atypical antipsychotic drugs, revealed a risk of death in the drug-treated patients of between 1.6 to 1.7 times the risk of death in placebo-treated patients. Over the course of a typical 10-week controlled trial, the rate of death in drug-treated patients was about 4.5%, compared to a rate of about 2.6% in the placebo group. Although the causes of death were varied, most of the deaths appeared to be either cardiovascular (e.g., heart failure, sudden death) or infectious (e.g., pneumonia) in nature.



Observational studies suggest that, similar to atypical antipsychotic drugs, treatment with conventional antipsychotic drugs may increase mortality. The extent to which the findings of increased mortality in observational studies may be attributed to the antipsychotic drug as opposed to some characteristic(s) of the patients is not clear. FANAPT is not approved for the treatment of patients with Dementia-Related Psychosis. [See Warnings and Precautions (5.1)]

1 INDICATIONS AND USAGE

FANAPT´┐Ż tablets are indicated for the treatment of adults with schizophrenia. Efficacy was established in two short-term (4- and 6-week) placebo and active-controlled studies of adult patients with schizophrenia [see Clinical Studies (14)].

When deciding among the alternative treatments available for this condition, the prescriber should consider the finding that FANAPT is associated with prolongation of the QTc interval [see Warnings and Precaution s (5.2)]. Prolongation of the QTc interval is associated in some other drugs with the ability to cause torsade de pointes-type arrhythmia, a potentially fatal polymorphic ventricular tachycardia which can result in sudden death. In many cases this would lead to the conclusion that other drugs should be tried first. Whether FANAPT will cause torsade de pointes or increase the rate of sudden death is not yet known.

Patients must be titrated to an effective dose of FANAPT.Thus, control of symptoms may be delayed during the first 1 to 2 weeks of treatment compared to some other antipsychotic drugs that do not require a similar titration. Prescribers should be mindful of this delay when selecting an antipsychotic drug for the treatment of schizophrenia [ s ee Dosage and Administration (2.1) and Clinical Studies (14)].

The effectiveness of FANAPT in long-term use, that is, for more than 6 weeks, has not been systematically evaluated in controlled trials. Therefore, the physician who elects to use FANAPT for extended periods should periodically re-evaluate the long-term usefulness of the drug for the individual patient [s ee Dosage and Administration (2.3)].

2 DOSAGE AND ADMINISTRATION

2.1 Usual Dose
FANAPT must be titrated slowly from a low starting dose to avoid orthostatic hypotension due to its alpha-adrenergic blocking properties. The recommended starting dose for FANAPT tablets is 1 mg twice daily. Dose increases to reach the target range of 6 to 12 mg twice daily (12 to 24 mg/day) may be made with daily dosage adjustments not to exceed 2 mg twice daily (4 mg/day). The maximum recommended dose is 12 mg twice daily (24 mg/day). FANAPT doses above 24 mg/day have not been systematically evaluated in the clinical trials. Efficacy was demonstrated with FANAPT in a dose range of 6 to 12 mg twice daily. Prescribers should be mindful of the fact that patients need to be titrated to an effective dose of FANAPT. Thus, control of symptoms may be delayed during the first 1 to 2 weeks of treatment compared to some other antipsychotic drugs that do not require similar titration. Prescribers should also be aware that some adverse effects associated with FANAPT use are dose related.

FANAPT can be administered without regard to meals.

NDC 00078-0602-08 UPC/GTIN No.3-00780-60208-2 Mfg.Part No.60208
Fanapt 1 2 4 6mg Tab 8 by Vanda Pharma
NDC 00078-0602-08 UPC/GTIN No.3-00780-60208-2 Mfg.Part No.60208

Vanda Pharmaceuticals Inc.

Vanda Pharmaceuticals Inc.

This Item Can Only Be Ordered By A Drug Mfg, Wholesaler,Pharmacy,Physician, Dentist, Podiatrist, Optometrist,Veterinarian,Naturopath,Licensed Lab, Physical Therapist & Pharmacist(scope).
ILOPERIDONE ORAL TAB DS P
This Item Can Only Be Ordered By A Drug Mfg, Wholesaler,Pharmacy,Physician, Dentist, Podiatrist, Optometrist,Veterinarian,Naturopath,Licensed Lab, Physical Therapist & Pharmacist(scope).