FORFIVO XL Rx

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FORFIVO XL

Mood disorders
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Generic Name and Formulations:

Bupropion HCl 450mg; ext-rel tabs.

Company:

Alvogen

Select therapeutic use:

Indications for FORFIVO XL:

Major depressive disorder.

Adult:

Do not use for initiation treatment; use other bupropion forms for initial dose titration. Swallow whole. One tab (450mg) once daily. May be used in patients receiving 300mg/day of another bupropion forms for at least 2 weeks and requiring a 450mg/day dose. Taper dose using another bupropion form prior to stopping Forfivo XL. Switching from other bupropion forms at 450mg/day: give equivalent dose of Forfivo XL once daily. Switching to/from MAOIs: see full labeling.

Children:

Not established.

Contraindications:

Seizure disorders. Bulimia. Anorexia nervosa. During or within 14 days of MAOIs. Concomitant linezolid or IV methylene blue. Abrupt withdrawal of alcohol, benzodiazepines, barbiturates, antiepileptics. Other forms of bupropion-containing products.

Warnings/Precautions:

Increased risk of suicidal thinking and behavior in children, adolescents, and young adults; monitor all patients for clinical worsening or unusual behavioral changes. Monitor for neuropsychiatric adverse events (eg, behavioral changes, agitation, depression, suicidal ideation); discontinue if occur. Pre-existing psychiatric disorders. Not for treating bipolar depression or for smoking cessation. Risk of seizures; discontinue if occurs: do not restart. Monitor BP prior to initiation and periodically during treatment. Bipolar disorder. Mania/hypomania. Angle-closure glaucoma. Unstable heart disease. CHF. Recent MI. Hepatic or renal impairment: not recommended. Reevaluate periodically. Write ℞ for smallest practical amount. Elderly. Pregnancy (Cat.C). Nursing mothers.

Interactions:

See Contraindications. Do not start with concomitant linezolid or IV methylene blue; if treatment necessary, discontinue bupropion before starting. Monitor for 2 weeks or until 24hrs after last dose of linezolid or IV methylene blue, whichever comes first. Concomitant CYP2B6 inhibitors (eg, ticlopidine or clopidogrel): not recommended. Avoid alcohol. Caution with levodopa, amantadine. Caution with drugs that lower seizure threshold (eg, theophylline, antidiabetics, anorectics, CNS stimulants, systemic steroids, antidepressants, antipsychotics) or factors that lower seizure threshold (eg, opiate or cocaine addiction, excessive use of alcohol or sedatives). May be antagonized by CYP2B6 inducers (eg, ritonavir, lopinavir, efavirenz, carbamazepine, phenobarbital, phenytoin); may need bupropion dose increase. May potentiate drugs metabolized by CYP2D6 (eg, venlafaxine, nortriptyline, imipramine, desipramine, paroxetine, fluoxetine, sertraline, haloperidol, risperidone, thioridazine, metoprolol, propafenone, flecainide); consider dose reduction of these drugs. May antagonize tamoxifen. Monitor for hypertension with nicotine replacement. May cause false (+) urine immunoassay test results for amphetamines.

Pharmacological Class:

Aminoketone.

Adverse Reactions:

Dry mouth, nausea, insomnia, dizziness, pharyngitis, abdominal pain, agitation, anxiety, tremor, palpitation, sweating, tinnitus, myalgia, anorexia, urinary frequency, rash; hypertension, hypersensitivity (discontinue if occurs).

Metabolism:

Hepatic (CYP2B6).

Elimination:

Renal, fecal.

Generic Availability:

NO

How Supplied:

Tabs—30

FORFIVO XL 450mg tablets (Qty:30)

appx. price $406.00