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Rx Item-Aplenzin 348mg bupropion HBr Oral Tab ER 24hr Tab 30 by Valeant Pharma

RX387213 387213 NDC No.00187-5811-30 0187-5811-30 00187581130 0187581130 UPC/GTIN No.3-01875-81130-3 301875-811303 301875811303  MPN 581130RX387213 387213 NDC No.00187-5811-30 0187-5811-30 00187581130 0187581130 UPC/GTIN No.3-01875-81130-3 301875-811303 301875811303  MPN 581130Only Lic.-Physician,Pharmacy,Dentist,Drug Mfg,Dist.,Gov,Hospital,Lic.Lab,Naturalist,Naturopath,NP,Optometrist,Pharmacist,PA,Physical Therapist,Podiatrist,Research Co.,Uni.,VA,Vet & Wholesalers in scopWant to do Research on this Med or need a large quantity? Email Details with quantity required to:sales@AmericanPharmaWholesale.comVisit AmericanPharmaWholesale.com for over 100,000 items of Health & Beauty at Retail@Wholesale prices.

Rx Item-Aplenzin 348mg bupropion HBr Oral Tab ER 24hr Tab 30 by Valeant Pharma

$2911.68$2799.00

RX387213 387213 NDC No.00187-5811-30 0187-5811-30 00187581130 0187581130 UPC/GTIN No.3-01875-81130-3 301875-811303 301875811303 MPN 581130 Only Lic.-Physician,Pharmacy,Dentist,Drug Mfg,Dist.,Gov,Hospital,Lic.Lab,Naturalist,Naturopath,NP,Optometrist,Pharmacist,PA,Physical Therapist,Podiatrist,Research Co.,Uni.,VA,Vet & Wholesalers in scope of practice can order this RX Item. Rx Item No.Rx387213 387213 Aplenzin 348mg Tab 30 by Valeant Pharma Item No.3387213 NDC No.00187581130 UPC No.30187581130

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Clinical Information
Gen. Code and Des.
64896 bupropion HBr ORAL TAB ER 24H 348MG
GCN and Des.
16996 bupropion HBr ORAL TAB ER 24H 348MG
Strength
348MG
Dose Form
TABLET, EXTENDED RELEASE 24 HR
Product Category
RX Pharmaceuticals
Fine Line Class
850085008510 All Rx Products
DEA Class
NC
OMP Family

AHFS Class
28160492 ANTIDEPRESSANTS, MISCELLANEOUS
Active Ingredients
12996 bupropion hydrobromide 905818691
Inactive Ingredients
2537 povidone 9003398

APLENZIN- bupropion hydrobromide tablet, extended release
Valeant Pharmaceuticals North America LLC

WARNING: SUICIDAL THOUGHTS AND BEHAVIORS and NEUROPSYCHIATRIC REACTIONS
SUICIDALITY AND ANTIDEPRESSANT DRUGS
Antidepressants increased the risk of suicidal thoughts and behavior in children, adolescents, and young adults in short-term trials. These trials did not show an increase in the risk of suicidal thoughts and behavior with antidepressants use in subjects aged 65 and older [see Warnings and Precautions ].
In patients of all ages who are started on antidepressant therapy, monitor closely for worsening, and for emergence of suicidal thoughts and behaviors. Advise families and caregivers of the need for close observation and communication with the prescriber [see Warnings and Precautions ].
NEUROPSYCHIATRIC REACTIONS IN PATIENTS TAKING BUPROPION FOR SMOKING CESSATION
Serious neuropsychiatric reactions have occurred in patients taking bupropion for smoking cessation [see Warnings and Precautions ]. The majority of these reactions occurred during bupropion treatment, but some occurred in the context of discontinuing treatment. In many cases, causal relationship to bupropion treatment is not certain, because depressed mood may be symptom of nicotine withdrawal. However, some of the cases occurred in patients taking bupropion who continued to smoke. Although APLENZIN is not approved for smoking cessation, observe all patients for neuropsychiatric reactions. Instruct the patient to contact healthcare provider if such reactions occu


DESCRIPTION
APLENZIN? (bupropion hydrobromide), an antidepressant of the aminoketone class, is chemically unrelated to tricyclic, tetracyclic, selective serotonin reuptake inhibitor, or other known antidepressant agents. Its structure closely resembles that of diethylpropion; it is related to phenylethylamines. It is designated as (?)-2-(tert-butylamino)-3?-chloropropiophenone hydrobromide. The molecular weight is 320.6. The molecular formula is C13 H18 ClNO?HBr. Bupropion hydrobromide powder is white or almost white, crystalline, and soluble in water. It has bitter taste and produces the sensation of local anesthesia on the oral mucosa
APLENZIN tablets are supplied for oral administration as 174 mg, 348 mg, and 522 mg white to off-white extended-release tablets. Each tablet contains the labeled amount of bupropion hydrobromide and the inactive ingredients: ethylcellulose, glyceryl behenate, polyvinyl alcohol, polyethylene glycol, povidone, and dibutyl sebacate. Carnauba wax is included in the 174 mg and 348 mg strengths. The tablets are printed with edible black ink.
The insoluble shell of the extended-release tablet may remain intact during gastrointestinal transit and is eliminated in the feces.
12 CLINICAL PHARMACOLOGY
12.1 Mechanism of Action
The mechanism of action of bupropion is unknown, as is the case with other antidepressants. However, it is presumed that this action is mediated by noradrenergic and/or dopaminergic mechanisms. Bupropion is relatively weak inhibitor of the neuronal uptake of norepinephrine and dopamine and does not inhibit monoamine oxidase or the reuptake of serotonin.
INDICATIONS AND USAGE
1.1 Major Depressive Disorder
APLENZIN? (bupropion hydrobromide extended-release tablets) is indicated for the treatment of major depressive disorder (MDD), as defined by the Diagnostic and Statistical Manual (DSM).
The efficacy of the immediate-release formulation of bupropion was established in two 4-week controlled inpatient trials and one 6-week controlled outpatient trial of adult patients with MDD. The efficacy of the sustained-release formulation of bupropion in the maintenance treatment of MDD was established in long-term (up to 44 weeks), placebo-controlled trial in patients who had responded to bupropion in an 8-week study of acute treatment
APLENZIN is indicated for the prevention of seasonal major depressive episodes in patients with diagnosis of seasonal affective disorder (SAD).
The efficacy of bupropion hydrochloride extended-release tablets in the prevention of seasonal major depressive episodes was established in placebo-controlled trials in adult outpatients with history of MDD with an autumn-winter seasonal pattern as defined in the DSM [see Clinical Studies ].
2 DOSAGE AND ADMINISTRATION
2.1 General Instructions for Use
To minimize the risk of seizure, increase the dose gradually
APLENZIN should be swallowed whole and not crushed, divided, or chewed. APLENZIN should be administered in the morning and may be taken with or without regard to meals.
2.2 Equivalent Daily Doses of APLENZIN (Bupropion hydrobromide) and Bupropion hydrochloride
See Table for equivalent daily doses of APLENZIN (bupropion hydrobromide) and bupropion hydrochloride.
APLENZIN (bupropion hydrobromide)
Bupropion hydrochloride
522 mg
450 mg
348 mg
300 mg
174 mg
150 mg
2.3 Dosage for Major Depressive Disorder (MDD)
The recommended starting dose for MDD is 174 mg once daily in the morning. After days of dosing, the dose may be increased to the target dose of 348 mg once daily in the morning.
It is generally agreed that acute episodes of depression require several months or longer of antidepressant treatment beyond the response in the acute episode. It is unknown whether the APLENZIN dose needed for maintenance treatment is identical to the dose that provided an initial response. Periodically reassess the need for maintenance treatment and the appropriate dose for such treatment.
To Discontinue APLENZIN, Taper the Dose
When discontinuing treatment in patients treated with APLENZIN 348 mg once daily, decrease the dose to 174 mg once daily prior to discontinuation.
2.6 Dosage Adjustment in Patients with Hepatic Impairment
In patients with moderate to severe hepatic impairment (Child-Pugh score: to 15), the maximum dose is 174 mg every other day. In patients with mild hepatic impairment (Child-Pugh score: to 6), consider reducing the dose and/or frequency of dosing [see Use in Specific Populations and Clinical Pharmacology (12.3)].
2.7 Dosage Adjustment in Patients with Renal Impairment
Consider reducing the dose and/or frequency of APLENZIN in patients with renal impairment
Switching Patient To or From Monoamine Oxidase Inhibitor (MAOI) Antidepressant
At least 14 days should elapse between discontinuation of an MAOI intended to treat depression and initiation of therapy with APLENZIN. Conversely, at least 14 days should be allowed after stopping APLENZIN before starting an MAOI antidepressant
Use of APLENZIN with Reversible MAOIs such as Linezolid or Methylene Blue
Do not start APLENZIN in patient who is being treated with reversible MAOI such as linezolid or intravenous methylene blue. Drug interactions can increase risk of hypertensive reactions
CONTRAINDICATIONS
The use of MAOIs (intended to treat psychiatric disorders) concomitantly with APLENZIN or within 14 days of discontinuing treatment with APLENZIN is contraindicated.
APLENZIN is contraindicated in patients with seizure disorder.
APLENZIN is contraindicated in patients with current or prior diagnosis of bulimia or anorexia nervosa.
APLENZIN is contraindicated in patients undergoing abrupt discontinuation of alcohol, benzodiazepines, barbiturates, and antiepileptic drugs.
WARNINGS AND PRECAUTIONS
5.1 Suicidal Thoughts and Behaviors in Children, Adolescents, and Young Adults
Neuropsychiatric Symptoms and Suicide Risk in Smoking Cessation Treatment
Seizure
APLENZIN can cause seizure.
Hypertension
Treatment with APLENZIN can result in elevated blood pressure and hypertension
Activation of Mania/Hypomania
Antidepressant treatment can precipitate manic, mixed, or hypomanic manic episode
Psychosis and Other Neuropsychiatric Reactions
Depressed patients treated with bupropion have had variety of neuropsychiatric signs and symptoms, including delusions, hallucinations, psychosis, concentration disturbance, paranoia, and confusion.
Angle-Closure Glaucoma
Angle-Closure Glaucoma: The pupillary dilation that occurs following use of many antidepressant drugs including APLENZIN may trigger an angle-closure attack in patient with anatomically narrow angles who does not have patent iridectomy.
DRUG ABUSE AND DEPENDENCE Controlled Substance
Bupropion is not controlled substance.

RX387213 387213 NDC No.00187-5811-30 0187-5811-30 00187581130 0187581130 UPC/GTIN No.3-01875-81130-3 301875-811303 301875811303  MPN 581130
Aplenzin 348mg Tab 30 by Valeant Pharma
RX387213 387213 NDC No.00187-5811-30 0187-5811-30 00187581130 0187581130 UPC/GTIN No.3-01875-81130-3 301875-811303 301875811303 MPN 581130

RX387213 387213 NDC No.00187-5811-30 0187-5811-30 00187581130 0187581130 UPC/GTIN No.3-01875-81130-3 301875-811303 301875811303  MPN 581130
AmericanPharmaWholesale.com
RX387213 387213 NDC No.00187-5811-30 0187-5811-30 00187581130 0187581130 UPC/GTIN No.3-01875-81130-3 301875-811303 301875811303 MPN 581130

Only Lic.-Physician,Pharmacy,Dentist,Drug Mfg,Dist.,Gov,Hospital,Lic.Lab,Naturalist,Naturopath,NP,Optometrist,Pharmacist,PA,Physical Therapist,Podiatrist,Research Co.,Uni.,VA,Vet & Wholesalers in scop
BUPROPION HBR ORAL TAB ER
Only Lic.-Physician,Pharmacy,Dentist,Drug Mfg,Dist.,Gov,Hospital,Lic.Lab,Naturalist,Naturopath,NP,Optometrist,Pharmacist,PA,Physical Therapist,Podiatrist,Research Co.,Uni.,VA,Vet & Wholesalers in scop

Want to do Research on this Med or need a large quantity? Email Details with quantity required to:sales@AmericanPharmaWholesale.com
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Visit AmericanPharmaWholesale.com for over 100,000 items of Health & Beauty at Retail@Wholesale prices.
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Visit AmericanPharmaWholesale.com for over 100,000 items of Health & Beauty at Retail@Wholesale prices.