Venlafaxine

/Venlafaxine
Venlafaxine2018-09-06T09:12:40+00:00

Prescription Drug Name:

Venlafaxine

ID:

53631CF3-39CF-14FB-A3BF-BEF967541E63

Code:

45129-4

WARNING: SUICIDALITY AND ANTIDEPRESSANT DRUGS


id: 8D3DED23-D0A4-9601-00D7-825B870E3366
displayName: BOXED WARNING SECTION
FDA Article Code: 34066-1

Antidepressants increased the risk compared to placebo of suicidal thinking and behavior (suicidality) in children, adolescents, and young adults in short-term studies of Major Depressive Disorder (MDD) and other psychiatric disorders. Anyone considering the use of Venlafaxine Extended Release Tablets or any other antidepressant in a child, adolescent, or young adult must balance this risk with the clinical need. Short-term studies did not show an increase in the risk of suicidality with antidepressants compared to placebo in adults beyond age 24; there was a reduction in risk with antidepressants compared to placebo in adults aged 65 and older. Depression and certain other psychiatric disorders are themselves associated with increases in the risk of suicide. Patients of all ages who are started on antidepressant therapy should be monitored appropriately and observed closely for clinical worsening, suicidality, or unusual changes in behavior. Families and caregivers should be advised of the need for close observation and communication with the prescriber. Venlafaxine Extended Release Tablets are not approved for use in pediatric patients. [See Warnings and Precautions (5.1) and Patient Counseling Information (17.1)]

2 DOSAGE AND ADMINISTRATION


id: 4F65D568-DFFB-6BD4-4F19-DA9F894D41C6
displayName: DOSAGE & ADMINISTRATION SECTION
FDA Article Code: 34068-7

Venlafaxine Extended Release Tablets should be administered in a single dose with food either in the morning or in the evening at approximately the same time each day. Each tablet should be swallowed whole with fluid and not divided, crushed, chewed, or placed in water.

3 DOSAGE FORMS AND STRENGTHS


id: CB542256-8B42-4EC3-8A77-A137A9440C44
displayName: DOSAGE FORMS & STRENGTHS SECTION
FDA Article Code: 43678-2

Venlafaxine Extended Release Tablets are available as:

37.5 mg tablets (round, biconvex, white coated tablets with OS301 printed on one side)

75 mg tablets (round, biconvex, white coated tablets with OS302 printed on one side)

150 mg tablets (round, biconvex, white coated tablets with OS303 printed on one side)

225 mg tablets (round, biconvex, white coated tablets with OS304 printed on one side)

4 CONTRAINDICATIONS


id: 1DA9EA0A-E2E1-B8DD-3DDD-84B323D5E07A
displayName: CONTRAINDICATIONS SECTION
FDA Article Code: 34070-3

Concomitant use in patients taking monoamine oxidase inhibitors (MAOIs) is contraindicated [see Warnings and Precautions (5.2)].

11 DESCRIPTION


id: 76988A20-FF14-1DA2-B389-E9434EA70EFD
displayName: DESCRIPTION SECTION
FDA Article Code: 34089-3

Venlafaxine Extended Release Tablets (venlafaxine hydrochloride) are extended-release tablets for oral administration that contain venlafaxine hydrochloride, a structurally novel antidepressant. Venlafaxine hydrochloride is a selective serotonin and norepinephrine reuptake inhibitor (SNRI). It is designated (R/S)-1-[2-(dimethylamino)-1-(4-methoxyphenyl)ethyl] cyclohexanol hydrochloride or (±)-1-[α-[(dimethylamino)methyl]-p-methoxybenzyl] cyclohexanol hydrochloride and has the empirical formula of C17H27NO2 HCl. Its molecular weight is 313.87. The structural formula is shown below.Venlafaxine hydrochloride is a white to off-white crystalline solid with a solubility of 572 mg/mL in water (adjusted to ionic strength of 0.2 M with sodium chloride). Its octanol:water (0.2 M sodium chloride) partition coefficient is 0.43.Venlafaxine Extended Release Tablets are formulated as extended-release tablet for once-a-day oral administration. Venlafaxine Extended Release Tablets use osmotic pressure to deliver venlafaxine hydrochloride at a controlled rate over approximately 24 hours. The system, which resembles a conventional tablet in appearance, comprises an osmotically active core surrounded by a semipermeable membrane. The unitary tablet core is composed of the drug and excipients (including the osmotically active components). There is a precision-laser drilled orifice in the semipermeable membrane on the side of the tablet. In an aqueous environment, such as the gastrointestinal tract, water permeates through the membrane into the tablet core, causing the drug to dissolve and the osmotic components to expand. This expansion pushes the drug out through the orifice. The semipermeable membrane controls the rate at which water permeates into the tablet core, which in turn controls the rate of drug delivery. The controlled rate of drug delivery into the gastrointestinal lumen is thus independent of pH or gastrointestinal motility. The function of Venlafaxine Extended Release Tablets depends on the existence of an osmotic gradient between the contents of the core and the fluid in the gastrointestinal tract. Since the osmotic gradient remains constant, drug delivery remains essentially constant. The biologically inert components of the tablet remain intact during gastrointestinal transit and are eliminated in the feces as an insoluble shell.Tablets contain venlafaxine hydrochloride equivalent to 37.5 mg, 75 mg, 150 mg, or 225 mg venlafaxine. Inactive ingredients consist of mannitol, povidone, microcrystalline cellulose, polyethylene glycol, colloidal silicon dioxide, magnesium stearate, cellulose acetate, hypromellose, lactose, titanium dioxide, triacetin, black iron oxide, and propylene glycol.

13 NONCLINICAL TOXICOLOGY


id: 4C538157-67A7-6ACB-98B9-789F5AFE374B
displayName: NONCLINICAL TOXICOLOGY SECTION
FDA Article Code: 43680-8

16 HOW SUPPLIED/STORAGE AND HANDLING


id: 1CECB77B-1511-C406-5C15-89A20E66EBE9
displayName: HOW SUPPLIED SECTION
FDA Article Code: 34069-5

Venlafaxine Extended Release Tablets 37.5 mg are round, biconvex, white coated tablets with OS301 printed on one side. They are supplied as follows:
  Bottles of 100 Tablets NDC 42843-301-10
  Box of single units of 100 NDC 42843-301-11
Venlafaxine Extended Release Tablets 75 mg are round, biconvex, white coated tablets with OS302 printed on one side. They are supplied as follows:
  Bottles of 100 Tablets NDC 42843-302-10
  Box of single units of 100 NDC 42843-302-11
Venlafaxine Extended Release Tablets 150 mg are round, biconvex, white coated tablets with OS303 printed on one side. They are supplied as follows:
  Bottles of 100 Tablets NDC 42843-303-10
  Box of single units of 100 NDC 42843-303-11
Venlafaxine Extended Release Tablets 225 mg are round, biconvex, white coated tablets with OS304 printed on one side. They are supplied as follows:
  Bottles of 100 Tablets NDC 42843-304-10
  Box of single units of 100 NDC 42843-304-11

17 PATIENT COUNSELING INFORMATION


id: EF7CDEBA-1E9C-44AB-426E-5549A6D7D58A
displayName: INFORMATION FOR PATIENTS SECTION
FDA Article Code: 34076-0

See FDA-approved Medication Guide (17.9)Prescribers or other health professionals should inform patients, their families, and their caregivers about the benefits and risks associated with treatment with Venlafaxine Extended Release Tablets and should counsel them in its appropriate use. A patient Medication Guide about “Antidepressant Medicines, Depression and Other Serious Mental Illness, and Suicidal Thoughts or Actions” is available for Venlafaxine Extended Release Tablets. The prescriber or health professional should instruct patients, their families, and their caregivers to read the Medication Guide and should assist them in understanding its contents. Patients should be given the opportunity to discuss the contents of the Medication Guide and to obtain answers to any questions they may have. The complete text of the Medication Guide is reprinted at the end of this document.Patients should be advised of the following issues and asked to alert their prescriber if these occur while taking Venlafaxine Extended Release Tablets.