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DESVENLAFAXINE EXTENDED-RELEASE- desvenlafaxine tablet, extended release


Patient Information

Advise the patient to read the FDA-approved patient labeling (Medication Guide).

Suicidal Thoughts and Behaviors

Advise patients and caregivers to look for the emergence of suicidality, especially early during treatment and when the dose is adjusted up or down, and instruct them to report such symptoms to the healthcare provider[see Boxed Warning and Warnings and Precautions (5.1)].

Concomitant Medication

Advise patients taking Desvenlafaxine Extended-Release Tablets not to use concomitantly other products containing desvenlafaxine or venlafaxine. Healthcare professionals should instruct patients not to take Desvenlafaxine Extended-Release Tablets with an MAOI or within 14 days of stopping an MAOI and to allow 7 days after stopping Desvenlafaxine Extended-Release Tablets before starting an MAOI[see Contraindications (4)].

Serotonin Syndrome

Caution patients about the risk of serotonin syndrome, particularly with the concomitant use of Desvenlafaxine Extended-Release Tablets with other serotonergic agents (including triptans, tricyclic antidepressants, fentanyl, lithium, tramadol, amphetamines, tryptophan, buspirone, and St. John's Wort supplements)[see Warnings and Precautions (5.2)].

Elevated Blood Pressure

Advise patients that they should have regular monitoring of blood pressure when taking Desvenlafaxine Extended-Release Tablets[see Warnings and Precautions (5.3)].

Increased Risk of Bleeding

Inform patients about the concomitant use of Desvenlafaxine Extended-Release Tablets with NSAIDs, aspirin, other antiplatelet drugs, warfarin, or other coagulants because the combined use of has been associated with an increased risk of bleeding. Advise patients to inform their healthcare providers if they are taking or planning to take any prescription or over-the-counter medications that increase the risk of bleeding[see Warnings and Precautions (5.4)].

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)].

Discontinuation

Advise patients not to abruptly stop taking Desvenlafaxine Extended-Release Tablets without talking first with their healthcare professional. Patients should be aware that discontinuation effects may occur when stopping Desvenlafaxine Extended-Release Tablets[see Warnings and Precautions (5.7) and Adverse Reactions (6.1)].

Switching Patients from Other Antidepressants to Desvenlafaxine Extended-Release Tablets

Discontinuation symptoms have been reported when switching patients from other antidepressants, including venlafaxine, to desvenlafaxine. Tapering of the initial antidepressant may be necessary to minimize discontinuation symptoms.

Interference with Cognitive and Motor Performance

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

Alcohol

Advise patients to avoid alcohol while taking Desvenlafaxine Extended-Release Tablets[see Drug Interactions (7.3)].

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. Advise patients that there is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to desvenlafaxine during pregnancy[see Use in Specific Populations (8.1)].

Residual Inert Matrix Tablet

Patients receiving Desvenlafaxine Extended-Release Tablets may notice an inert matrix tablet 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 inert matrix tablet.

Manufactured for:
Osmotica Pharmaceutical US LLC
Marietta, GA 30062

By: Alcami
1726 North 23rd Street,
Wilmington, NC 28405

Distributed by:
Macoven Pharmaceuticals, LLC

Morristown, NJ 07960

OS374-01-84-03
PC 4738GP



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