VENLAFAXINE HYDROCHLORIDE capsule, extended release

Maa: Yhdysvallat

Kieli: englanti

Lähde: NLM (National Library of Medicine)

Aktiivinen ainesosa:

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

Saatavilla:

AvKARE

INN (Kansainvälinen yleisnimi):

VENLAFAXINE HYDROCHLORIDE

Koostumus:

VENLAFAXINE 37.5 mg

Antoreitti:

ORAL

Prescription tyyppi:

PRESCRIPTION DRUG

Käyttöaiheet:

1.1 Major Depressive Disorder Venlafaxine hydrochloride extended-release capsules are indicated for the treatment of major depressive disorder (MDD). Efficacy was established in three short-term (4, 8, and 12 weeks) and two long-term, maintenance trials. 1.2 Generalized Anxiety Disorder Venlafaxine hydrochloride extended-release capsules are indicated for the treatment of Generalized Anxiety Disorder (GAD). Efficacy was established in two 8-week and two 26-week placebo-controlled trials. 1.3 Social Anxiety Disorder Venlafaxine hydrochloride extended-release capsules are indicated for the treatment of Social Anxiety Disorder (SAD), also known as social phobia. Efficacy was established in four 12-week and one 26- week, placebo-controlled trials. 1.4 Panic Disorder Venlafaxine hydrochloride extended-release capsules are indicated for the treatment of Panic Disorder (PD), with or without agoraphobia. Efficacy was established in two 12-week placebo-controlled trials. Venlafaxine hydrochloride extended-release capsules are indicated for the treatment of major depressive disorder (MDD). Efficacy was established in three short-term (4, 8, and 12 weeks) and two long-term, maintenance trials. Venlafaxine hydrochloride extended-release capsules are indicated for the treatment of Generalized Anxiety Disorder (GAD). Efficacy was established in two 8-week and two 26-week placebo-controlled trials. Venlafaxine hydrochloride extended-release capsules are indicated for the treatment of Social Anxiety Disorder (SAD), also known as social phobia. Efficacy was established in four 12-week and one 26- week, placebo-controlled trials. Venlafaxine hydrochloride extended-release capsules are indicated for the treatment of Panic Disorder (PD), with or without agoraphobia. Efficacy was established in two 12-week placebo-controlled trials. 4.1 Hypersensitivity Hypersensitivity to venlafaxine hydrochloride, desvenlafaxine succinate or to any excipients in the formulation 4.2 Concomitant Use with Monoamine Oxidase Inhibitors (MAOIs) The use of MAOIs (intended to treat psychiatric disorders) concomitantly with venlafaxine hydrochloride extended-release capsules or within 7 days of discontinuing treatment with venlafaxine hydrochloride extended-release capsules is contraindicated because of an increased risk of serotonin syndrome. The use of venlafaxine hydrochloride extended-release capsules within 14 days of discontinuing treatment with an MAOI (intended to treat psychiatric disorders) is also contraindicated [see Dosage and Administration (2.9), Warnings and Precautions (5.2), and Drug Interactions (7.2)]. Starting venlafaxine hydrochloride extended-release capsules in a patient who is being treated with an MAOI such as linezolid or intravenous methylene blue is also contraindicated, because of an increased risk of serotonin syndrome [see Dosage and Administration (2.9), Warnings and Precautions (5.2), and Drug Interactions (7.3)]. Hypersensitivity to venlafaxine hydrochloride, desvenlafaxine succinate or to any excipients in the formulation The use of MAOIs (intended to treat psychiatric disorders) concomitantly with venlafaxine hydrochloride extended-release capsules or within 7 days of discontinuing treatment with venlafaxine hydrochloride extended-release capsules is contraindicated because of an increased risk of serotonin syndrome. The use of venlafaxine hydrochloride extended-release capsules within 14 days of discontinuing treatment with an MAOI (intended to treat psychiatric disorders) is also contraindicated [see Dosage and Administration (2.9), Warnings and Precautions (5.2), and Drug Interactions (7.2)]. Starting venlafaxine hydrochloride extended-release capsules in a patient who is being treated with an MAOI such as linezolid or intravenous methylene blue is also contraindicated, because of an increased risk of serotonin syndrome [see Dosage and Administration (2.9), Warnings and Precautions (5.2), and Drug Interactions (7.3)]. Teratogenic Effects – Pregnancy Category C 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. In reproductive developmental studies in rats and rabbits with O-desmethylvenlafaxine (ODV), the major human metabolite of venlafaxine, evidence of teratogenicity was not observed at exposure margins of 13 in rats and 0.3 in rabbits. There are no adequate and well-controlled studies in pregnant women. Venlafaxine hydrochloride extended-release capsules should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. 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, or SSRIs, 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) and Drug Interactions (7.3)]. When treating a pregnant woman with venlafaxine hydrochloride extended-release capsules during the third trimester, the physician should carefully consider the potential risks and benefits of treatment. 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 hydrochloride extended-release capsules, 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. Two placebo-controlled trials in 766 pediatric patients with MDD and two placebo-controlled trials in 793 pediatric patients with GAD 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 hydrochloride extended-release capsules in a child or adolescent must balance the potential risks with the clinical need [see Boxed Warning, Warnings and Precautions (5.1, 5.10, 5.11) and Adverse Reactions (6.4)]. Although no studies have been designed to primarily assess venlafaxine hydrochloride extended-release capsules’s impact on the growth, development, and maturation of children and adolescents, the studies that have been done suggest that venlafaxine hydrochloride extended-release capsules may adversely affect weight and height [see Warnings and Precautions (5.10)]. Should the decision be made to treat a pediatric patient with venlafaxine hydrochloride extended-release capsules, regular monitoring of weight and height is recommended during treatment, particularly if treatment is to be continued long-term [see Warnings and Precautions (5.10, 5.11)]. The safety of venlafaxine hydrochloride extended-release capsule 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, 6.3)]. The percentage of patients in clinical studies for venlafaxine hydrochloride extended-release capsules for MDD, GAD, SAD, and PD who were 65 years of age or older are shown in Table 15. * In addition, in the premarketing assessment of venlafaxine tablets (immediate release), 12% (357/2,897) of patients were   65 years of age. 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 event [see Warnings and Precautions (5.9)]. The pharmacokinetics of venlafaxine and ODV are not substantially altered in the elderly [see Clinical Pharmacology (12.3)] (see Figure 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 (2.6)]. A population pharmacokinetic analysis of 404 venlafaxine-treated patients from two studies involving both twice daily and three times daily regimens showed that dose-normalized trough plasma levels of either venlafaxine or ODV were unaltered by age or gender differences. Dosage adjustment based on the age or gender of a patient is generally not necessary [see Dosage and Administration (2.6)] (see Table 15). Abbreviations: ODV, O-desmethylvenlafaxine; AUC, area under the curve; Cmax, peak plasma concentrations; * Similar effect is expected with strong CYP2D6 inhibitors Venlafaxine hydrochloride extended-release capsules are not a controlled substance. While venlafaxine has not been systematically studied in clinical studies for its potential for abuse, there was no indication of drug-seeking behavior in the clinical studies. 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, incrementation 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 (2.8)].

Tuoteyhteenveto:

Venlafaxine hydrochloride extended-release capsules USP are available as follows: 37.5 mg - light-gray opaque cap/buff opaque body with “93” and “7384” on both body and cap. They are available in bottles of 30 (NDC 42291-897-30), 90 (NDC 42291-897-90) and 500 (NDC 42291-897-50). 75 mg - buff opaque cap/buff opaque body with “93” and “7385” on both body and cap. They are available in bottles of 30 (NDC 42291-898-30), 90 (NDC 42291-898-90) and 500 (NDC 42291-898-50). 150 mg - light-orange opaque cap/light-orange opaque body with “93” and “7386” on both body and cap. They are available in bottles of 30 (NDC 42291-899-30), 90 (NDC 42291-899-90) and 500 (NDC 42291-899-50). Store at 20  to 25 C (68  to 77 F) [See USP Controlled Room Temperature]. Dispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure (as required). KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN.

Valtuutuksen tilan:

Abbreviated New Drug Application

Pakkausseloste

VENLAFAXINE HYDROCHLORIDE- VENLAFAXINE HYDROCHLORIDE CAPSULE, EXTENDED
RELEASE
AvKARE
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MEDICATION GUIDE
Venlafaxine (VEN la fax een) Hydrochloride Extended-Release Capsules
USP
Read the Medication Guide that comes with venlafaxine hydrochloride
extended-release
capsules before you start taking them and each time you get a refill.
There may be new
information. This Medication Guide does not take the place of talking
to your healthcare
provider about your medical condition or treatment. Talk with your
healthcare provider if there
is something you do not understand or want to learn more about.
What is the most important information I should know about venlafaxine
hydrochloride extended- release capsules?
Venlafaxine hydrochloride extended-release capsules and other
antidepressant medicines
may cause serious side effects, including:
1. Suicidal thoughts or actions:
• Venlafaxine hydrochloride extended-release capsules and other
antidepressant
medicines may increase suicidal thoughts or actions in some children,
teenagers, or
young adults within the first few months of treatment or when the dose
is changed.
• Depression or other serious mental illnesses are the most
important causes of suicidal
thoughts or actions.
• Watch for these changes and call your healthcare provider right
away if you notice:
• New or sudden changes in mood, behavior, actions, thoughts, or
feelings, especially if severe.
• Pay particular attention to such changes when venlafaxine
hydrochloride
extended-release capsules are started or when the dose is changed.
Keep all follow-up visits with your healthcare provider and call
between visits if you are worried
about symptoms.
Call your healthcare provider right away if you have any of the
following symptoms,
or call 911 if an emergency, especially if they are new, worse, or
worry you:
• attempts to commit suicide
• acting on dangerous impulses
• acting aggressive or violent
• thoughts about suicide or dying
• new or worse depression
• new or worse anxiety or panic at

Valmisteyhteenveto

VENLAFAXINE HYDROCHLORIDE- VENLAFAXINE HYDROCHLORIDE CAPSULE, EXTENDED
RELEASE
AVKARE
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HIGHLIGHTS OF PRESCRIBING INFORMATION
VENLAFAXINE HYDROCHLORIDE EXTENDED-RELEASE CAPSULES, FOR ORAL USE
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
VENLAFAXINE
HYDROCHLORIDE EXTENDED-RELEASE CAPSULES SAFELY AND EFFECTIVELY. SEE
FULL PRESCRIBING
INFORMATION FOR VENLAFAXINE HYDROCHLORIDE EXTENDED-RELEASE CAPSULES
INITIAL U.S. APPROVAL: 1997
WARNING: SUICIDAL THOUGHTS AND BEHAVIORS
SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING.
INCREASED RISK OF SUICIDAL THINKING AND BEHAVIOR IN CHILDREN,
ADOLESCENTS AND YOUNG
ADULTS TAKING ANTIDEPRESSANTS (5.1)
MONITOR FOR WORSENING AND EMERGENCE OF SUICIDAL THOUGHTS AND BEHAVIORS
(5.1)
VENLAFAXINE HYDROCHLORIDE EXTENDED-RELEASE CAPSULES ARE NOT APPROVED
FOR USE IN
PEDIATRIC PATIENTS (8.4)
INDICATIONS AND USAGE
Venlafaxine hydrochloride extended-release capsules are a serotonin
and norepinephrine reuptake
inhibitor (SNRI) indicated for the treatment of: (1) (1) (1)
• Major Depressive Disorder (MDD) (1)
• Generalized Anxiety Disorder (GAD) (1)
• Social Anxiety Disorder (SAD) (1)
• Panic Disorder (PD) (1)
DOSAGE AND ADMINISTRATION
Indication Starting Dose Target Dose Maximum Dose (2)
MDD (2.1) 37.5 to 75 mg/day 75 mg/day 225 mg/day (2)
GAD (2.2) 37.5 to 75 mg/day 75 mg/day 225 mg/day (2)
SAD (2.3) 75 mg/day 75 mg/day 75 mg/day (2)
PD (2.4) 37.5 mg/day 75 mg/day 225 mg/day (2)
• Take once daily with food (2). Capsules should be taken whole; do
not divide, crush, chew, or dissolve (2).
(2)
• When discontinuing treatment, reduce the dose gradually (2.8,
5.7). (2)
• Renal impairment: reduce the total daily dose by 25% to 50% in
patients with renal impairment. Reduce
the total daily dose by 50% or more in patients (2)
undergoing dialysis or with severe renal impairment (2.6). (2)
• Hepatic impairment: reduce the daily dose by 50% in patients with
mild to moderate hepatic
impairment. In patients with severe hepatic impairment or hepatic (2)
ci