Venlafaxine Hydrochloride (Page 13 of 15)

14.5 Pediatric Patients

Two placebo-controlled studies in 766 pediatric patients with MDD and two placebo-controlled studies 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.

16 HOW SUPPLIED/STORAGE AND HANDLING

Venlafaxine hydrochloride extended-release capsules USP are available as follows:
Venlafaxine hydrochloride extended-release capsules USP, 37.5 mg are white to off white colored, round to oval shaped pellets filled in size ‘3’ hard Gelatin capsules with grey opaque cap imprinted with ‘V’ in black color, white opaque body imprinted with ‘9’ in black color.
Bottle of 30 capsules NDC 31722-002-30
Bottle of 90 capsules NDC 31722-002-90
Bottle of 500 capsules NDC 31722-002-05
Carton of 100 (10 x 10) unit-dose capsules (Alu-Blister pack) NDC 31722-002-01
Venlafaxine hydrochloride extended-release capsules USP, 75 mg are white to off white colored, round to oval shaped pellets filled in size ‘1’ hard Gelatin capsules with peach opaque cap imprinted with ‘V’ in black color, white opaque body imprinted with ’10’ in black color.
Bottle of 30 capsules NDC 31722-003-30
Bottle of 90 capsules NDC 31722-003-90
Bottle of 500 capsules NDC 31722-003-05
Carton of 100 (10 x 10) unit-dose capsules (Alu-Blister pack) NDC 31722-003-01
Venlafaxine hydrochloride extended-release capsules USP, 150 mg are white to off white colored, round to oval shaped pellets filled in size ‘0’ hard Gelatin capsules with orange opaque cap imprinted with ‘V’ in black color, white opaque body imprinted with ’11’ in black color.
Bottle of 30 capsules NDC 31722-004-30
Bottle of 90 capsules NDC 31722-004-90
Bottle of 500 capsules NDC 31722-004-05
Carton of 100 (10 x 10) unit-dose capsules (Alu-Blister pack) NDC 31722-004-01
Store at controlled room temperature, 20° to 25°C (68° to 77°F). [see USP Controlled Room Temperature]

17 PATIENT COUNSELING INFORMATION

See FDA-approved patient labeling (Medication Guide).
Prescribers or other healthcare professionals should inform patients, their families, and their caregivers about the benefits and risks associated with treatment with venlafaxine hydrochloride extended-release capsules and should counsel them in its appropriate use. A patient Medication Guide about ”Antidepressant Medicines, Depression and Other Serious Mental Illnesses, and Suicidal Thoughts or Actions” is available for venlafaxine hydrochloride extended-release capsules. The prescriber or healthcare 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 should be asked to alert their prescriber if these occur while taking venlafaxine hydrochloride extended-release capsules.
Suicidal Thoughts and Behaviors
Advise patients, their families and caregivers to look for the emergence of suicidality, worsening of depression, and other psychiatric symptoms (anxiety, agitation, panic attacks, insomnia, irritability, hostility, aggressiveness, impulsivity, akathisia, psychomotor restlessness, hypomania, mania, other unusual changes in behavior), especially early during treatment and when the dose is adjusted up or down. Such symptoms should be reported to the patient’s prescriber or health professional, especially if they are severe, abrupt in onset, or were not part of the patient’s presenting symptoms. Symptoms such as these may be associated with an increased risk for suicidal thinking and behavior and indicate a need for very close monitoring [see Boxed Warning and Warnings and Precautions ( 5.1)].
Concomitant Medication
Advise patients taking venlafaxine hydrochloride extended-release capsules not to use concomitantly other products containing venlafaxine or desvenlafaxine. Healthcare professionals should instruct patients not to take venlafaxine hydrochloride extended-release capsules with an MAOI or within 14 days of stopping an MAOI and to allow 7 days after stopping venlafaxine hydrochloride extended-release capsules before starting an MAOI [see Contraindications ( 4.2)].
Serotonin Syndrome
Patients should be cautioned about the risk of serotonin syndrome, with the concomitant use of venlafaxine hydrochloride extended-release capsules and triptans, tramadol, amphetamines, tryptophan supplements, with antipsychotics or other dopamine antagonists, or other serotonergic agents [see Warnings and Precautions ( 5.2) and Drug Interactions ( 7.3)].
Elevated Blood Pressure
Advise patients that they should have regular monitoring of blood pressure when taking venlafaxine hydrochloride extended-release capsules [see Warnings and Precautions ( 5.3)].
Abnormal Bleeding
Patients should be cautioned about the concomitant use of venlafaxine hydrochloride extended-release capsules and NSAIDs, aspirin, warfarin, or other drugs that affect coagulation since combined use of psychotropic drugs that interfere with serotonin reuptake and these agents has been associated with an increased risk of bleeding [see Warnings and Precautions ( 5.4)].
Angle Closure Glaucoma
Patients should be advised that taking venlafaxine hydrochloride extended-release capsules can cause mild pupillary dilation, which in susceptible individuals, can lead to an episode of angle closure glaucoma. Pre-existing glaucoma is almost always open-angle glaucoma because angle closure glaucoma, when diagnosed, can be treated definitively with iridectomy. Open-angle glaucoma is not a risk factor for angle closure glaucoma. Patients may wish to be examined to determine whether they are susceptible to angle closure, and have a prophylactic procedure (e.g., iridectomy), if they are susceptible [see Warnings and Precautions ( 5.5)].
Activation of Mania/Hypomania
Advise patients, their families and caregivers to observe for signs of activation of mania/hypomania [see Warnings and Precautions ( 5.6)].
Cardiovascular/Cerebrovascular Disease
Caution is advised in administering venlafaxine hydrochloride extended-release capsules to patients with cardiovascular, cerebrovascular, or lipid metabolism disorders [see Adverse Reactions ( 6.1)].
Serum Cholesterol and Triglyceride Elevation
Advise patients that elevations in total cholesterol, LDL and triglycerides may occur and that measurement of serum lipids may be considered [see Warnings and Precautions ( 6.3)].
Discontinuation [Symptoms]
Advise patients not to stop taking venlafaxine hydrochloride extended-release capsules without talking first with their healthcare professional. Patients should be aware that discontinuation effects may occur when stopping venlafaxine hydrochloride extended-release capsules [see Warnings and Precautions ( 5.7) and Adverse Reactions ( 6.1)].
Sexual Dysfunction
Advise patients that use of venlafaxine hydrochloride extended-release capsules may cause symptoms of sexual dysfunction in both male and female patients. Inform patients that they should discuss any changes in sexual function and potential management strategies with their healthcare provider [see Warnings and Precautions ( 5.13)].
Interference with Cognitive and Motor Performance
Caution patients about operating hazardous machinery, including automobiles, until they are reasonably certain that venlafaxine hydrochloride extended-release capsules therapy does not adversely affect their ability to engage in such activities.
Alcohol
Advise patients to avoid alcohol while taking venlafaxine hydrochloride extended-release capsules [see Drug Interactions ( 7.6)].
Allergic Reactions
Advise patients to notify their physician if they develop allergic phenomena such as rash, hives, swelling, or difficulty breathing.
Pregnancy
Advise patients to notify their physician if they become pregnant or intend to become pregnant during therapy [see Use in Specific Populations ( 8.1)].
Nursing
Advise patients to notify their physician if they are breast-feeding an infant [see Use in Specific Populations ( 8.3)].
Residual Spheroids
Venlafaxine hydrochloride extended-release capsules contains spheroids, which release the drug slowly into the digestive tract. The insoluble portion of these spheroids is eliminated, and patients may notice spheroids passing in the stool or via colostomy. Patients should be informed that the active medication has already been absorbed by the time the patient sees the spheroids.

Manufactured for:
Camber Pharmaceuticals, Inc.
Piscataway, NJ 08854

By: Annora Pharma Pvt. Ltd.
Sangareddy — 502313, Telangana, India

Revised: 10/2021