Desvenlafaxine (Page 7 of 7)
16 HOW SUPPLIED/STORAGE AND HANDLING
Desvenlafaxine Extended-Release Tablets are available as follows:
25 mg, light tan, square pyramid film coated tablet, debossed with “YH” and “137” on the flat side
NDC: 70518-3195-00
PACKAGING: 90 in 1 BOTTLE PLASTIC
Store at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature].
Each tablet contains 38 mg of desvenlafaxine succinate equivalent to 25 mg of desvenlafaxine, respectively.
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Remedy Repack, Inc.
625 Kolter Dr. Suite #4 Indiana, PA 1-724-465-8762
17 PATIENT COUNSELING INFORMATION
Advise the patient to read the FDA-approved patient labeling (Medication Guide).
Repackaged By / Distributed By: RemedyRepack Inc.
625 Kolter Drive, Indiana, PA 15701
(724) 465-8762
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 not to use concomitantly other products containing desvenlafaxine or venlafaxine. Healthcare professionals should instruct patients not to take desvenlafaxine with an MAOI or within 14 days of stopping an MAOI and to allow 7 days after stopping desvenlafaxine before starting an MAOI [see Contraindications ( 4)] .
Serotonin Syndrome
Caution patients about the risk of serotonin syndrome, particularly with the concomitant use of desvenlafaxine with other serotonergic agents (including triptans, tricyclic antidepressants, opioids, lithium, 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 [see Warnings and Precautions ( 5.3)] .
Increased Risk of Bleeding
Inform patients about the concomitant use of desvenlafaxine 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 Syndrome
Advise patients not to abruptly stop taking desvenlafaxine without talking first with their healthcare professional. Patients should be aware that discontinuation effects may occur when stopping desvenlafaxine, and a dose of 25 mg per day is available for discontinuing therapy [see Warnings and Precautions ( 5.7) and Adverse Reactions ( 6.1)] .
Sexual Dysfunction
Advise patients that use of desvenlafaxine 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 ( 5.11)] .
Switching Patients from Other Antidepressants to Desvenlafaxine
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 therapy does not adversely affect their ability to engage in such activities.
Alcohol
Advise patients to avoid alcohol while taking desvenlafaxine [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 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.
Repackaged and Distributed By:
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625 Kolter Dr. Suite #4 Indiana, PA 1-724-465-8762
MEDICATION GUIDE Desvenlafaxine (des VEN la FAX een) Extended-Release Tablets |
What is the most important information I should know about desvenlafaxine? Desvenlafaxine can cause serious side effects, including:
How can I watch for and try to prevent suicidal thoughts and actions? Call your healthcare provider right away if you have any of the following symptoms, especially if they are new, worse, or worry you: o thoughts about suicide or dying o trouble sleeping (insomnia) o attempts to commit suicide o new or worse irritability o new or worse depression o acting aggressive, being angry, or violent o new or worse anxiety o acting on dangerous impulses o feeling very agitated or restless o an extreme increase in activity and talking (mania) o panic attacks o other unusual changes in behavior or mood |
What is Desvenlafaxine?
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Do not take desvenlafaxine if you:
Do not start taking an MAOI for at least 7 days after you stop treatment with desvenlafaxine. |
Before taking desvenlafaxine tell your healthcare provider about all your medical conditions, including if you:
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o Tell your healthcare provider if you become pregnant or think you are pregnant during treatment with desvenlafaxine.
o If you become pregnant during treatment with desvenlafaxine, talk to your healthcare provider about registering with the National Pregnancy Registry for Antidepressants. You can register by calling 1-844-405-6185.
Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Desvenlafaxine and other medicines may affect each other causing possible serious side effects. Desvenlafaxine may affect the way other medicines work and other medicines may affect the way desvenlafaxine works. Especially tell your healthcare provider if you take:
Do not start or stop any other medicines during treatment with desvenlafaxine without talking to your healthcare provider first. Stopping desvenlafaxine suddenly may cause you to have serious side effects. See, “What are the possible side effects of desvenlafaxine?” Know the medicines you take. Keep a list of them to show to your healthcare providers when you get a new medicine. |
How should I take desvenlafaxine?
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What should I avoid while taking desvenlafaxine?
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What are the possible side effects of desvenlafaxine? Desvenlafaxine can cause serious side effects, including:
o agitation o seeing or hearing things that are not real (hallucinations) o confusion o coma o fast heart beat o changes in blood pressure o dizziness o sweating o flushing o high body temperature (hyperthermia) o tremors, stiff muscles, or muscle twitching o loss of coordination o seizures o nausea, vomiting, diarrhea
o dizziness o ringing in your ears (tinnitus) o headache o irritability and agitation o nausea o diarrhea o anxiety o problems sleeping o abnormal dreams o aggressiveness (including hostility, rage) o tiredness o changes in your mood o tremor o confusion o hypomania o sweating o electric shock sensation (paresthesia) o problems with eyesight (such as blurred vision and trouble focusing) o seizures o increase in blood pressure
• difficulty concentrating • memory changes • confusion • weakness and unsteadiness on your feet which can lead to falls In severe or more sudden cases, signs and symptoms include: • hallucinations (seeing or hearing things that are not real) • fainting • seizures • coma
The most common side effects of desvenlafaxine include: • nausea • dizziness • problems sleeping • sweating • constipation • feeling sleepy • decreased appetite • anxiety • sexual function problems These are not all the possible side effects of desvenlafaxine. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. |
How should I store desvenlafaxine?
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General Information about the safe and effective use of desvenlafaxine Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not take desvenlafaxine for a condition for which it was not prescribed. Do not give desvenlafaxine to other people, even if they have the same symptoms that you have. It may harm them. You can ask your pharmacist or healthcare provider for information about desvenlafaxine that is written for healthcare professionals. For more information, contact Slate Run Pharmaceuticals, LLC at 1-888-341-9214. |
What are the ingredients in desvenlafaxine? Active ingredient: desvenlafaxine Inactive ingredients:
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This Medication Guide has been approved by the U.S. Food and Drug Administration.
For additional copies of the Medication Guide, please visit www.slaterunpharma.com/products/.
Repackaged By / Distributed By: RemedyRepack Inc.
625 Kolter Drive, Indiana, PA 15701
(724) 465-8762
Repackaged and Distributed By:
Remedy Repack, Inc.
625 Kolter Dr. Suite #4 Indiana, PA 1-724-465-8762
DRUG: Desvenlafaxine
GENERIC: Desvenlafaxine
DOSAGE: TABLET, EXTENDED RELEASE
ADMINSTRATION: ORAL
NDC: 70518-3195-0
COLOR: brown
SHAPE: SQUARE
SCORE: No score
SIZE: 9 mm
IMPRINT: YH;137
PACKAGING: 90 in 1 BOTTLE, PLASTIC
ACTIVE INGREDIENT(S):
- DESVENLAFAXINE SUCCINATE 25mg in 1
INACTIVE INGREDIENT(S):
- SILICON DIOXIDE
- HYPROMELLOSE, UNSPECIFIED
- MAGNESIUM STEARATE
- MICROCRYSTALLINE CELLULOSE
- POLYETHYLENE OXIDE 900000
- TALC
- FERROSOFERRIC OXIDE
- FERRIC OXIDE RED
- FERRIC OXIDE YELLOW
- POLYVINYL ALCOHOL GRAFT POLYETHYLENE GLYCOL COPOLYMER (3:1; 45000 MW)
- TITANIUM DIOXIDE
DESVENLAFAXINE desvenlafaxine tablet, extended release | ||||||||||||||||||||||||||
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Labeler — REMEDYREPACK INC. (829572556) |
Revised: 03/2024 REMEDYREPACK INC.
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