VENLAFAXINE tablet, coated

Ország: Egyesült Államok

Nyelv: angol

Forrás: NLM (National Library of Medicine)

Aktív összetevők:

VENLAFAXINE HYDROCHLORIDE (UNII: 7D7RX5A8MO) (VENLAFAXINE - UNII:GRZ5RCB1QG)

Beszerezhető a:

Cadila Pharmaceuticals Limited

Az alkalmazás módja:

ORAL

Recept típusa:

PRESCRIPTION DRUG

Terápiás javallatok:

Venlafaxine extended-release tablets are indicated for the treatment of major depressive disorder (MDD). Efficacy of venlafaxine in MDD was shown in both short-term trials and a longer-term trial in MDD [see Clinical Studies (14.1)] . A major depressive episode (DSM-IV) implies a prominent and relatively persistent (nearly every day for at least 2 weeks) depressed mood or the loss of interest or pleasure in nearly all activities, representing a change from previous functioning, and includes the presence of at least five of the following nine symptoms during the same two-week period: depressed mood, markedly diminished interest or pleasure in usual activities, significant change in weight and/or appetite, insomnia or hypersomnia, psychomotor agitation or retardation, increased fatigue, feelings of guilt or worthlessness, slowed thinking or impaired concentration, a suicide attempt or suicidal ideation. Venlafaxine extended-release tablets are indicated for the treatment of Social Anxiety Disorder (SAD), also known as Social Phobia, as defined in DSM-IV. Social Anxiety Disorder (DSM-IV) is characterized by a marked and persistent fear of 1 or more social or performance situations in which the person is exposed to unfamiliar people or to possible scrutiny by others. Exposure to the feared situation almost invariably provokes anxiety, which may approach the intensity of a panic attack. The feared situations are avoided or endured with intense anxiety or distress. The avoidance, anxious anticipation, or distress in the feared situation(s) interferes significantly with the person's normal routine, occupational or academic functioning, or social activities or relationships, or there is a marked distress about having the phobias. Lesser degrees of performance anxiety or shyness generally do not require psychopharmacological treatment. Efficacy of venlafaxine extended release in the treatment of SAD was established in short-term SAD trials [see Clinical Studies (14.2)] . The use of MAOI’s intended to treat psychiatric disorders with venlafaxine extended-release tablets or within 7 days of stopping treatment with venlafaxine extended-release tablets are contraindicated because of an increased risk of serotonin syndrome. The use of venlafaxine extended-release tablets within 14 days of stopping, an MAOI intended to treat psychiatric disorders is also contraindicated [see Dosage and Administrations (2.6) and Warnings and Precautions (5.2)] . Starting venlafaxine extended-release tablets in a patient who is being treated with MAOIs such as linezolid or intravenous methylene blue is also contraindicated because of an increased risk of serotonin syndrome [see Dosage and Administrations   (2.7) and Warnings and Precautions (5.2)] . Based on data from published observational studies, exposure to SNRIs, particularly in the month before delivery, has been associated with a less than 2-fold increase in the risk of postpartum hemorrhage [see Warnings and Precautions (5.13) and Clinical Considerations].   Teratogenic Effects        Venlafaxine did not cause malformations in offspring of rats or rabbits given doses up to 2.5 times (rat) or 4 times (rabbit) the maximum recommended human daily dose on a mg/m2 basis.  However, in rats, there was a decrease in pup weight, an increase in stillborn pups, and an increase in pup deaths during the first 5 days of lactation, when dosing began during pregnancy and continued until weaning. The cause of these deaths is not known. These effects occurred at 2.5 times (mg/m2 ) the maximum human daily dose. The no effect dose for rat pup mortality was 0.25 times the human dose on a mg/m2 basis. There are no adequate and well-controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed. Non-Teratogenic Effects Neonates exposed to venlafaxine hydrochloride extended-release capsules, other SNRIs (Serotonin and Norepinephrine Reuptake Inhibitors), or SSRIs (Selective Serotonin Reuptake Inhibitors), late in the third trimester have developed complications requiring prolonged hospitalization, respiratory support, and tube feeding. Such complications can arise immediately upon delivery. Reported clinical findings have included respiratory distress, cyanosis, apnea, seizures, temperature instability, feeding difficulty, vomiting, hypoglycemia, hypotonia, hypertonia, hyperreflexia, tremor, jitteriness, irritability, and constant crying. These features are consistent with either a direct toxic effect of SSRIs and SNRIs or, possibly, a drug discontinuation syndrome. It should be noted that, in some cases, the clinical picture is consistent with serotonin syndrome [see Warnings and Precautions (5.2)] . When treating a pregnant woman with venlafaxine extended-release tablets during the third trimester, the physician should carefully consider the potential risks and benefits of treatment. Maternal Adverse Reactions Exposure to Venlafaxine Extended Release Tablets in mid to late pregnancy may increase the risk of preeclampsia, and exposure to Venlafaxine Extended Release Tablets in the month before delivery may be associated with an increased risk of postpartum hemorrhage [see Warnings and Precautions (5.13)]. The effect of venlafaxine on labor and delivery in humans is unknown. Venlafaxine and ODV have been reported to be excreted in human milk. Because of the potential for serious adverse reactions in nursing infants from venlafaxine extended-release tablets, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother. Safety and effectiveness in the pediatric population have not been established [see BOXED WARNING and Warnings and Precautions (5.1)] . Two placebo-controlled trials in 766 pediatric patients with MDD and two placebo-controlled trials in another disorder in 793 pediatric patients have been conducted with venlafaxine hydrochloride extended-release capsules, and the data were not sufficient to support a claim for use in pediatric patients. Anyone considering the use of venlafaxine extended-release tablets in a child or adolescent must balance the potential risks with the clinical need. Although no studies have been designed to primarily assess impact of venlafaxine hydrochloride extended-release capsules on the growth, development, and maturation of children and adolescents, the studies that have been done suggest that venlafaxine extended-release tablets may adversely affect weight and height [see Warnings and Precautions (5.7, 5.8, and 5.9)] . Should the decision be made to treat a pediatric patient with venlafaxine extended-release tablets, regular monitoring of weight and height is recommended during treatment, particularly if it is to be continued long term. The safety of venlafaxine extended-release tablets treatment for pediatric patients has not been systematically assessed for chronic treatment longer than six months in duration. In the studies conducted in pediatric patients (ages 6 to 17), the occurrence of blood pressure and cholesterol increases considered to be clinically relevant in pediatric patients was similar to that observed in adult patients. Consequently, the precautions for adults apply to pediatric patients [see Warnings and Precautions (5.3 and 5.14)] . Approximately 4% (14/357) and 2% (6/277) of patients treated with venlafaxine hydrochloride extended-release capsules in placebo-controlled premarketing major depressive disorder and Social Anxiety Disorder trials, respectively, were 65 years of age or over. Of 2,897 patients treated with venlafaxine hydrochloride immediate-release tablets in premarketing phase major depressive disorder studies, 12% (357) were 65 years of age or over. No overall differences in effectiveness or safety were observed between geriatric patients and younger patients, and other reported clinical experience generally has not identified differences in response between the elderly and younger patients. However, greater sensitivity of some older individuals cannot be ruled out. SSRIs and SNRIs, including venlafaxine hydrochloride extended-release capsules have been associated with cases of clinically significant hyponatremia in elderly patients, who may be at greater risk for this adverse reaction [see Warnings and Precautions (5.11)] . The pharmacokinetics of venlafaxine and ODV are not substantially altered in the elderly [see Clinical Pharmacology (12.3)] . No dose adjustment is recommended for the elderly on the basis of age alone, although other clinical circumstances, some of which may be more common in the elderly, such as renal or hepatic impairment, may warrant a dose reduction [see Dosage and Administration (2.3)] . In patients with cirrhosis of the liver, the clearances of venlafaxine and its active metabolite (ODV) were decreased, thus prolonging the elimination half-lives of these substances. A large degree of intersubject variability was noted. [See Clinical Pharmacology (12.3)]. A lower dose and individualization of dosing may be necessary [see Dosage and Administration (2.3)] . Venlafaxine extended-release tablets, like all drugs effective in the treatment of major depressive disorder, should be used with caution in such patients. In patients with renal impairment (GFR = 10 to 70 mL/min), the clearances of venlafaxine and its active metabolites were decreased, thus prolonging the elimination half-lives of these substances [see Clinical Pharmacology (12.3)] . It is recommended that the total daily dose be reduced by 25% to 50% in patients with renal impairment. Because there was much individual variability in clearance between patients with renal impairment, individualization of dosage may be desirable in some patients. In patients undergoing hemodialysis, it is recommended that the total daily dose be reduced by 50%. [see Dosage and Administration (2.3)]. Venlafaxine extended-release tablets, like all drugs effective in the treatment of major depressive disorder, should be used with caution in such patients. Venlafaxine extended-release tablets (venlafaxine hydrochloride) are not a controlled substance. While venlafaxine has not been systematically studied in clinical trials for its potential for abuse, there was no indication of drug-seeking behavior in the clinical trials. However, it is not possible to predict on the basis of premarketing experience the extent to which a CNS active drug will be misused, diverted, and/or abused once marketed. Consequently, physicians should carefully evaluate patients for history of drug abuse and follow such patients closely, observing them for signs of misuse or abuse of venlafaxine (e.g., development of tolerance, incrementations of dose, drug-seeking behavior). In vitro studies revealed that venlafaxine has virtually no affinity for opiate, benzodiazepine, phencyclidine (PCP), or N-methyl-D-aspartic acid (NMDA) receptors. Venlafaxine was not found to have any significant CNS stimulant activity in rodents. In primate drug discrimination studies, venlafaxine showed no significant stimulant or depressant abuse liability. Discontinuation effects have been reported in patients receiving venlafaxine [see Dosage and Administration (2.4) and Warnings and Precautions (5.5)] .

Termék összefoglaló:

Venlafaxine extended-release tablets 75 mg are white to off - white, round, coated tablets imprinted with black ink “C46” on one side and plain on the other side. They are supplied as follows: Unit of use bottles of 30 tablets     NDC 71209-087-01 Unit of use bottles of 90 tablets     NDC 71209-087-04 Bottles of 1000 tablets NDC 71209-087-11 Venlafaxine extended-release tablets 150 mg are white to off - white, round, coated tablets imprinted with black ink “C34” on one side and plain on the other side. They are supplied as follows: Unit of use bottles of 30 tablets NDC 71209-088-01 Unit of use bottles of 90 tablets NDC 71209-088-04 Bottles of 1000 tablets NDC 71209-088-11 Venlafaxine extended-release tablets 225 mg are white to off - white, round, coated tablets imprinted with black ink “C49” on one side and plain on the other side. They are supplied as follows: Unit of use bottles of 30 tablets NDC 71209-089-01 Unit of use bottles of 90 tablets NDC 71209-089-04 Bottles of 1000 tablets NDC 71209-089-11 Store at 20° to 25°C (68° to 77°F); excursions permitted between 15° to 30°C (59° to 86°F) [See USP Controlled Room Temperature]. Protect from moisture and humidity.

Engedélyezési státusz:

Abbreviated New Drug Application

Termékjellemzők

VENLAFAXINE - VENLAFAXINE TABLET, COATED
CADILA PHARMACEUTICALS LIMITED
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
VENLAFAXINE EXTENDED-
RELEASE TABLETS SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING
INFORMATION FOR VENLAFAXINE
EXTENDED-RELEASE TABLETS. VENLAFAXINE EXTENDED-RELEASE TABLETS, FOR
ORAL USE INITIAL
U.S. APPROVAL: 1993
WARNING: SUICIDALITY AND ANTIDEPRESSANTS
_SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING._
INCREASED RISK OF SUICIDAL THINKING AND BEHAVIOR IN CHILDREN,
ADOLESCENTS AND YOUNG
ADULTS TAKING ANTIDEPRESSANTS FOR MAJOR DEPRESSIVE DISORDER (MDD) AND
OTHER
PSYCHIATRIC DISORDERS. VENLAFAXINE EXTENDED-RELEASE TABLETS ARE NOT
APPROVED FOR USE
IN PEDIATRIC PATIENTS. (5.1)
RECENT MAJOR CHANGES
Warning and Precautions (5.2, 5.13) 8/2023
INDICATIONS AND USAGE
Venlafaxine extended-release tablets are a selective serotonin and
norepinephrine reuptake inhibitor
(SNRI) indicated for:
Major Depressive Disorder (MDD) (1.1)
Social Anxiety Disorder (SAD) (1.2)
DOSAGE AND ADMINISTRATION
Initial Treatment (2.1)
INDICATION
STARTING DOSE
DOSE INCREASE
MAXIMUM DOSE
Major Depressive
Disorder
75 mg/day (in some patients, 37.5
mg/day for 4 to 7 days)
75 mg/day increments at
intervals of 4 days or longer
225 mg/day
Social Anxiety
Disorder
75 mg/day
No benefit at higher doses
75 mg/day
Venlafaxine extended-release tablets should be taken as a single daily
dose with food in either the
morning or evening at the same time each day. (2)
Discontinuation: Gradual; individualized as necessary. (2.4)
DOSAGE FORMS AND STRENGTHS
75 mg, 150 mg, and 225 mg tablets (3)
CONTRAINDICATIONS
Serotonin Syndrome and MAOIs: Do not use MAOI’s intended to treat
psychiatric disorders with
venlafaxine extended-release tablets or within 7 days of stopping
treatment with venlafaxine extended-
release tablets. Do not use venlafaxine extended-release tablets
within 14 days of stopping an MAOI
intended to treat psychiatric disorders. In addition, do not start
ven