Venlafaxine Hydrochloride Capsule, Extended Release
Product Images NDC 42291-897

Product Visual Gallery

This gallery contains 26 technical images submitted to the FDA as part of the official labeling for Venlafaxine Hydrochloride (NDC 42291-897). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.

As provided by Avkare, these visuals offer a comprehensive scientific overview of the product's physical and chemical identity, aiding pharmacists and researchers in product verification and study.

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Structural Formula For Venlafaxing Hydrochloride (23ff0ea7 F380 48e2 A8c3 0b113fa64e0d 01)

Chemical structure of venlafaxine hydrochloride showing its molecular arrangement including a cyclohexane ring, phenyl ring with a methoxy group, and other molecular components labeled with atoms and bonds.*

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897 30 37.5mg 30ct

Label for Venlafaxine Hydrochloride Extended-release Capsules USP, 37.5 mg strength, in a package of 30 capsules. The label features the AvKARE logo and states the product is sealed for protection. It includes storage instructions, prescription status (Rx only), and manufacturer information for AvKARE, a subsidiary of PharMEDium Services LLC.*

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898 30 75mg 30ct

Packaging label for Venlafaxine Hydrochloride Extended-release Capsules USP 75 mg by AvKARE. The label specifies 30 capsules, oral route, with a notice that the capsules are sealed for protection and for prescription use only. The label includes usage warnings and storage instructions on the side.*

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899 30 150mg 30ct

Packaging label for Venlafaxine Hydrochloride Extended-release Capsules USP, 150 mg strength. The label indicates a quantity of 30 capsules, sealed for protection. The labeler is AvKARE, and the product is for prescription use only. Additional text includes dispensing instructions and manufacturing details.*

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Figure 1

A pharmacokinetic (PK) fold change graph showing the effect of various interacting drugs on venlafaxine and its metabolite ODV's Cmax and AUC. The chart includes drugs like ethanol, diazepam, cimetidine, ketoconazole, indinavir, metoprolol, imipramine, and lithium, along with clinical recommendations for use such as caution in certain patients or no dose adjustment needed.*

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Figure 2

A pharmacokinetic interaction chart showing the effect of venlafaxine on various interacting drugs and their active metabolites. The chart plots the fold change in Cmax and AUC for analytes such as ethanol, diazepam, alprazolam, indinavir, metoprolol, risperidone, imipramine, haloperidol, caffeine, tolbutamide, and lithium relative to a reference value, along with clinical recommendations for concomitant use.*

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Figure 3

A pharmacokinetic chart showing fold change and 90% confidence intervals for venlafaxine and its metabolite O-desmethylvenlafaxine (ODV) in various special populations. The chart compares drug exposure metrics (Cmax and AUC) relative to reference values, with dosing recommendations for hepatic impairment, renal impairment, CYP2D6 polymorphism, age over 60, and gender.*

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Table 1

A data table showing the difference in the number of cases of suicidality per 1,000 patients treated versus placebo, segmented by age range. It lists increases in cases for patients under 18 and ages 18 to 24 and decreases in cases for patients aged 25 to 64 and 65 or older.*

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Table 10

Data table titled 'Final On-therapy Mean Changes From Baseline in Supine Systolic (SSBP) and Diastolic (SDBP) Blood Pressure (mm Hg) in Placebo-controlled Studies' presenting mean blood pressure changes for Venlafaxine Hydrochloride Extended-release Capsules at dosages ≤75 mg/day and >75 mg/day compared to placebo, across indications including MDD, GAD, SAD, and PD with varying durations.*

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Table 11

A data table titled 'Sustained Elevations in SDBP in Venlafaxine Hydrochloride Extended-release Capsules Premarketing Studies' presenting incidence rates of sustained systolic blood pressure elevations by indication, dose range, and incidence percentage for MDD, GAD, SAD, and PD conditions.*

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Table 12

A table presenting the approximate mean final on-therapy increase in pulse rate (beats per minute) for Venlafaxine Hydrochloride extended-release capsules compared to placebo in premarketing placebo-controlled studies up to 12 weeks. It lists pulse rate changes by indication: MDD, GAD, SAD, and PD with study durations and corresponding values for drug and placebo groups.*

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Table 13

A table titled 'Mean Final On-therapy Changes in Cholesterol Concentrations (mg/dL) in Venlafaxine Hydrochloride Extended-release Capsules Premarketing Studies.' It compares cholesterol changes for Venlafaxine Hydrochloride Extended-release Capsules versus placebo across indications including MDD, GAD, SAD, and PD, with data presented over various durations like 8 weeks, 12 weeks, and 6 months.*

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Table 14

A data table showing mean final on-therapy increases in triglyceride concentrations (mg/dL) in Venlafaxine Hydrochloride extended-release capsules premareketing studies. The table compares values for venlafaxine extended-release capsules and placebo across different indications and durations (SAD 12 weeks and 6 months, PD 12 weeks and 6 months).*

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Table 15

A data table titled 'Table 15' showing the percentage and number of patients aged 65 and older by indication who were studied using Venlafaxine Hydrochloride extended-release capsules. The indications listed are MDD, GAD, SAD, and PD with corresponding patient percentages and counts.*

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Table 16

A data table titled 'Comparison of Cmax and Tmax Values for Venlafaxine and ODV Following Oral Administration of Venlafaxine Hydrochloride Extended-release Capsules and Venlafaxine Tablets (Immediate Release).' It presents Cmax (ng/mL) and Tmax (hours) for Venlafaxine and ODV after administration of 150 mg once daily extended-release capsules and 75 mg twice daily immediate-release tablets.*

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Table 17

A data table titled 'Table 17: Major Depressive Disorder Studies' presenting study numbers, treatment groups, and efficacy measures of Venlafaxine Hydrochloride forms. It shows mean baseline scores, least-squares mean change from baseline, and placebo-subtracted differences in HAM-D scores for extended-release capsules (75 to 225 mg/day) and immediate release tablets (150 to 375 mg/day). The table includes statistical notes on the significance of differences and standard deviations.*

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Table 18

A data table titled 'Table 18: Generalized Anxiety Disorder Studies' presenting study results comparing Venlafaxine Hydrochloride extended-release (Ven XR) at various dosages (37.5 mg, 75 mg, 150 mg, 225 mg) versus placebo. It includes columns for study number, treatment group, primary efficacy measure with HAM-D Score mean baseline and changes, and placebo-subtracted differences with confidence intervals.*

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Table 19

A data table titled 'Social Anxiety Disorder Studies,' presenting study numbers, treatment groups, and primary efficacy measures based on LSAS scores. It compares mean baseline scores, least squares mean change from baseline, and placebo-subtracted differences with confidence intervals across different Venlafaxine XR dosage groups and placebo in five distinct studies.*

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Table 2

A data table titled 'Incidence (%) of Mania or Hypomania Reported in Venlafaxine Hydrochloride Extended-release Capsule Treated Patients in the Premarketing Studies.' It compares incidence percentages across four indications for Venlafaxine Hydrochloride extended-release capsules versus placebo: MDD, GAD, SAD, and PD.*

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Table 20

A data table titled 'Table 20: Panic Disorder Studies' summarizing results from two studies evaluating treatment groups including Venlafaxine Hydrochloride extended release (Ven XR) at various doses versus placebo. The table presents the percent of patients free of full-symptom panic attacks, adjusted odds ratios compared to placebo, and 95% confidence intervals for each treatment group.*

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Table 3 And 4

Two tables showing data from double-blind, placebo-controlled studies of Venlafaxine Hydrochloride extended-release capsules in pediatric patients. The first table details average change in body weight (kg) from treatment start for indications MDD, GAD, and SAD over 8 and 16 weeks. The second table shows the incidence percentage of pediatric patients experiencing at least 3.5% weight loss during the same studies and indications.*

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Table 5

A data table showing average height increases (in cm) in pediatric patients during placebo-controlled studies of Venlafaxine Hydrochloride Extended-release Capsules. The table compares height increases across three indications: MDD (8 weeks), GAD (8 weeks), and SAD (16 weeks), listing values for Venlafaxine Hydrochloride and placebo groups with sample sizes (n) included. A noted p value of 0.041 is indicated for one comparison.*

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Table 6

A data table showing the incidence (%) of decreased appetite and associated discontinuation rates (%) in pediatric patients from placebo-controlled studies of Venlafaxine Hydrochloride extended-release capsules. The table compares incidence and discontinuation rates for Venlafaxine Hydrochloride versus placebo in indications MDD and GAD (pooled, 8 weeks) and SAD (16 weeks).*

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Table 7

A data table titled 'Table 7' showing the incidence percentage of patients reporting adverse reactions leading to discontinuation in placebo-controlled clinical studies of Venlafaxine Hydrochloride extended-release capsules versus placebo. The table lists body systems, specific adverse reactions, and corresponding percentages for both Venlafaxine Hydrochloride (n=3,558) and placebo (n=2,197). Adverse reactions include asthenia, headache, nausea, dizziness, insomnia, somnolence, skin and appendages problems, and sweating.*

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Table 8

Table 8 listing the number of patients receiving Venlafaxine Hydrochloride Extended-release Capsules in premarketing clinical studies for various indications including MDD, GAD, SAD, and PD, with specific patient counts for each condition.*

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Table 9

Table showing common adverse reactions reported by patients taking Venlafaxine Hydrochloride Extended-release Capsules compared to placebo in studies up to 12 weeks. It lists percentages of patients experiencing various body system effects such as asthenia, cardiovascular, digestive, nervous system, respiratory, skin, special senses, and urogenital symptoms across both treatment and placebo groups.*

* About these descriptions: Image descriptions on this page are generated by automated AI analysis of the product label images from the manufacturer's FDA label submission (SPL). They are provided for reference only and may contain errors or omissions. Always rely on the printed label itself and the official FDA labeling, and consult a pharmacist or healthcare professional with any questions about this product.