Effexor XR (Page 11 of 13)

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 Effexor XR, and the data were not sufficient to support a claim for use in pediatric patients.

16 HOW SUPPLIED/STORAGE AND HANDLING

Effexor XR® (venlafaxine hydrochloride) extended-release capsules are available as follows:

  • 37.5 mg, grey cap/peach body with “W” and “Effexor XR” on the cap and “37.5” on the body.
    NDC 0008-0837-20, bottle of 15 capsules in unit-of-use package.
    NDC 0008-0837-21, bottle of 30 capsules in unit-of-use package.
    NDC 0008-0837-22, bottle of 90 capsules in unit-of-use package.
    NDC 0008-0837-03, carton of 10 Redipak® blister strips of 10 capsules each.
  • 75 mg, peach cap and body with “W” and “Effexor XR” on the cap and “75” on the body.
    NDC 0008-0833-20, bottle of 15 capsules in unit-of-use package.
    NDC 0008-0833-21, bottle of 30 capsules in unit-of-use package.
    NDC 0008-0833-22, bottle of 90 capsules in unit-of-use package.
    NDC 0008-0833-03, carton of 10 Redipak® blister strips of 10 capsules each.
  • 150 mg, dark orange cap and body with “W” and “Effexor XR” on the cap and “150” on the body.
    NDC 0008-0836-20, bottle of 15 capsules in unit-of-use package.
    NDC 0008-0836-21, bottle of 30 capsules in unit-of-use package.
    NDC 0008-0836-22, bottle of 90 capsules in unit-of-use package.NDC 0008-0836-03, carton of 10 Redipak® blister strips of 10 capsules each.

Store at controlled room temperature, 20° to 25°C (68° to 77°F).

The unit-of-use package is intended to be dispensed as a unit.

The appearance of these capsules is a trademark of Wyeth Pharmaceuticals.

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 Effexor XR 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 Effexor XR. 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 Effexor XR.

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 Effexor XR not to use concomitantly other products containing venlafaxine or desvenlafaxine. Healthcare professionals should instruct patients not to take Effexor XR with an MAOI or within 14 days of stopping an MAOI and to allow 7 days after stopping Effexor XR 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 Effexor XR and triptans, tramadol, amphetamines, tryptophan supplements, with antipsychotics or other dopamine antagonists, or other serotonergic agents [ s ee 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 Effexor XR [see Warnings and Precautions (5.3)].

Abnormal Bleeding

Patients should be cautioned about the concomitant use of Effexor XR 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 Effexor XR 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 Effexor XR 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 Effexor XR without talking first with their healthcare professional. Patients should be aware that discontinuation effects may occur when stopping Effexor XR [see Warnings and Precautions (5.7) and Adverse Reactions (6.1)].

Interference with Cognitive and Motor Performance

Caution patients about operating hazardous machinery, including automobiles, until they are reasonably certain that Effexor XR therapy does not adversely affect their ability to engage in such activities.

Alcohol

Advise patients to avoid alcohol while taking Effexor XR [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

Effexor XR 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.

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