Desvenlafaxine ER Tabs 100mg

Desvenlafaxine is a selective serotonin and norepinephrine reuptake inhibitor (SNRI). It enhances the neurotransmission of serotonin and norepinephrine in the central nervous system by blocking their reuptake pumps, leading to increased concentrations of these neurotransmitters in the synaptic cleft. This action is believed to be responsible for its antidepressant effects.

Urgent Side Effects: Seek Medical Help Right Away

Although rare, some people may experience severe and potentially life-threatening side effects while taking this medication. If you notice any of the following symptoms, contact your doctor or seek medical attention immediately:

Signs of an allergic reaction: rash, hives, itching, red, swollen, blistered, or peeling skin (with or without fever), wheezing, tightness in the chest or throat, trouble breathing, swallowing, or talking, unusual hoarseness, or swelling of the mouth, face, lips, tongue, or throat
Signs of low sodium levels: headache, trouble focusing, memory problems, feeling confused, weakness, seizures, or changes in balance
Signs of bleeding: vomiting or coughing up blood, vomit that resembles coffee grounds, blood in the urine, black, red, or tarry stools, bleeding from the gums, abnormal vaginal bleeding, unexplained bruises or bruises that enlarge, or uncontrollable bleeding
Signs of high blood pressure: severe headache or dizziness, fainting, or changes in vision
Signs of lung or breathing problems: shortness of breath or other breathing difficulties, cough, or fever
Chest pain or pressure
Seizures
Hallucinations (seeing or hearing things that are not there)
Sex problems, including decreased interest in sex, difficulty having an orgasm, ejaculation problems, or trouble getting or maintaining an erection

Additionally, a severe and potentially life-threatening condition called serotonin syndrome may occur, especially if you are taking certain other medications. Seek medical help immediately if you experience any of the following symptoms:
Agitation
Changes in balance
Confusion
Hallucinations
Fever
Rapid or abnormal heartbeat
Flushing
Muscle twitching or stiffness
Seizures
Shivering or shaking
Excessive sweating
Severe diarrhea, nausea, or vomiting
Severe headache

Other Possible Side Effects

Like all medications, this drug may cause side effects. While many people do not experience any side effects or only have mild ones, it is essential to discuss any concerns with your doctor. If you experience any of the following side effects or any other symptoms that bother you or do not resolve, contact your doctor or seek medical attention:
Dizziness, drowsiness, fatigue, or weakness
Nausea or vomiting
Constipation
Dry mouth
Difficulty sleeping
Decreased appetite
Sweating
Shakiness

This is not an exhaustive list of possible side effects. If you have questions or concerns about side effects, consult your doctor. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.

Before Taking This Medication: Important Information to Share with Your Doctor

It is essential to inform your doctor about the following conditions and situations to ensure safe treatment:

Any allergies you have, including allergies to this medication, its components, or other substances. Be sure to describe the allergic reaction you experienced.
A diagnosis of narrow-angle glaucoma.
High blood pressure.
Current or recent use of certain medications, including:
+ Linezolid or methylene blue.
+ Drugs for depression or Parkinson's disease taken within the last 14 days, such as isocarboxazid, phenelzine, tranylcypromine, selegiline, or rasagiline, as this may lead to very high blood pressure.
Use of another medication that contains the same active ingredient as this drug.
Use of a similar medication, if you are unsure, consult your doctor or pharmacist.

This list is not exhaustive, and it is crucial to disclose all your medications, including prescription and over-the-counter drugs, natural products, and vitamins, as well as any health problems you have. Your doctor and pharmacist need this information to assess potential interactions and ensure it is safe for you to take this medication. Never start, stop, or change the dose of any medication without first consulting your doctor.

It is essential to inform all your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are taking this medication. The full effects of this drug may not be apparent for several months.

To ensure your safety, avoid driving and other activities that require alertness until you understand how this medication affects you. When changing positions, rise slowly from sitting or lying down to minimize the risk of dizziness or fainting. Be cautious when navigating stairs.

Do not abruptly stop taking this medication without consulting your doctor, as this may increase your risk of side effects, which can be severe and long-lasting. If you need to discontinue this drug, your doctor will provide guidance on how to gradually stop taking it. If you experience new or worsening symptoms, discuss them with your doctor.

This medication may cause high blood pressure, so it is crucial to have your blood pressure monitored as directed by your doctor. Avoid consuming alcohol while taking this drug. Before using marijuana, cannabis, or prescription or over-the-counter medications that may impair your actions, consult with your doctor.

There is a potential increased risk of bleeding associated with this medication, which can be life-threatening in some cases. Discuss this risk with your doctor. Certain individuals may have a higher risk of eye problems when taking this drug. Your doctor may recommend an eye exam to assess your risk. If you experience eye pain, changes in vision, or swelling and redness around the eye, contact your doctor immediately.

Low blood sodium levels, which can be fatal in severe cases, may occur with this medication. Discuss this risk with your doctor. High cholesterol has also been reported in patients taking this drug; if you have concerns, consult with your doctor.

This medication may affect certain laboratory tests, so it is essential to inform all your healthcare providers and laboratory personnel that you are taking this drug. If you notice what appears to be a tablet in your stool, this is a normal occurrence and not a cause for concern; however, if you have questions, discuss them with your doctor.

If you are 65 or older, use this medication with caution, as you may be more susceptible to side effects. If you are pregnant, plan to become pregnant, or are breastfeeding, discuss the benefits and risks of this medication with your doctor. Taking this drug during the third trimester of pregnancy may increase the risk of bleeding after delivery and potentially cause health problems in the newborn. If you are breastfeeding, your doctor will help you weigh the risks to your baby.

• Monoamine Oxidase Inhibitors (MAOIs) - risk of serotonin syndrome
• Linezolid (an antibiotic with MAOI activity)
• Methylene Blue (an MAOI)

• Other serotonergic drugs (e.g., SSRIs, other SNRIs, triptans, fentanyl, tramadol, tryptophan, buspirone, St. John's Wort) - increased risk of serotonin syndrome
• Anticoagulants/Antiplatelets (e.g., warfarin, aspirin, NSAIDs) - increased risk of bleeding
• Drugs that increase blood pressure or heart rate (e.g., stimulants, decongestants, certain migraine medications) - additive effects
• Drugs that prolong the QT interval - theoretical risk, monitor

• Alcohol - may enhance CNS depressant effects
• Cimetidine - may increase desvenlafaxine levels (minor effect)
• Drugs metabolized by CYP2D6 (e.g., atomoxetine, desipramine, metoprolol, venlafaxine) - desvenlafaxine is a weak CYP2D6 inhibitor, may increase levels of these drugs

• No specific minor interactions commonly cited as clinically significant.

• Worsening depression
• Suicidal thoughts or behavior
• Unusual changes in behavior (e.g., agitation, irritability, aggression, panic attacks, insomnia, impulsivity, akathisia, hypomania, mania)
• Headache
• Nausea
• Dizziness
• Insomnia
• Sweating
• Dry mouth
• Constipation
• Sexual dysfunction
• Blurred vision
• Urinary retention
• Signs of serotonin syndrome (e.g., agitation, hallucinations, rapid heart rate, fever, sweating, muscle rigidity, tremor, incoordination, nausea, vomiting, diarrhea)
• Signs of hyponatremia (e.g., headache, difficulty concentrating, memory impairment, confusion, weakness, unsteadiness, falls, severe and more frequent seizures)

Use during pregnancy should be considered only if the potential benefit justifies the potential risk to the fetus. Exposure to SNRIs late in the third trimester may result in complications in the neonate requiring prolonged hospitalization, respiratory support, and tube feeding. These complications can include respiratory distress, cyanosis, apnea, seizures, temperature instability, feeding difficulty, vomiting, hypoglycemia, hypotonia, hypertonia, hyperreflexia, tremor, jitteriness, irritability, and constant crying. There is also a potential risk of persistent pulmonary hypertension of the newborn (PPHN) with SNRI exposure during late pregnancy.

Desvenlafaxine is excreted into human milk. The decision to breastfeed should consider the developmental and health benefits of breastfeeding, the mother's clinical need for desvenlafaxine, and any potential adverse effects on the breastfed infant from desvenlafaxine or from the underlying maternal condition. Monitor breastfed infants for sedation, poor feeding, and poor weight gain.

Safety and efficacy have not been established in pediatric patients for Major Depressive Disorder. Antidepressants, including desvenlafaxine, carry a Black Box Warning for increased risk of suicidal thoughts and behavior in children, adolescents, and young adults.

No overall differences in safety or effectiveness were observed between elderly and younger patients, but greater sensitivity of some older individuals cannot be ruled out. Elderly patients may be at increased risk for hyponatremia and falls. Dosage adjustments may be necessary in elderly patients with renal impairment.

• Desvenlafaxine is the major active metabolite of venlafaxine, offering a simpler pharmacokinetic profile (less CYP metabolism) and once-daily dosing.
• Always titrate down slowly when discontinuing desvenlafaxine to minimize withdrawal symptoms, which can be significant (e.g., dizziness, nausea, headache, paresthesias, anxiety, insomnia).
• Monitor blood pressure closely, especially during the initial weeks of treatment and with dose increases, as sustained hypertension can occur.
• Be vigilant for symptoms of serotonin syndrome, particularly when co-administered with other serotonergic agents.
• The tablet matrix may be visible in the stool; this is normal and does not mean the medication was not absorbed.

• Other SNRIs (e.g., venlafaxine, duloxetine, levomilnacipran)
• SSRIs (e.g., fluoxetine, sertraline, escitalopram, citalopram, paroxetine)
• Atypical antidepressants (e.g., bupropion, mirtazapine, vortioxetine, vilazodone)
• Tricyclic Antidepressants (TCAs)
• MAOIs (reserved for refractory cases)

If your symptoms or health issues persist or worsen, it's essential to contact your doctor for further guidance. To ensure your safety, never share your medication with others or take someone else's medication.

This medication is accompanied by a Medication Guide, which is a valuable resource that provides important information about your treatment. Please read this guide carefully and review it again whenever you receive a refill of your medication. If you have any questions or concerns about your medication, don't hesitate to discuss them with your doctor, pharmacist, or other healthcare provider.

In the event of a suspected overdose, it's crucial to seek immediate medical attention. Call your local poison control center or visit the emergency room right away. When seeking help, be prepared to provide detailed information about the overdose, including the name of the medication taken, the amount, and the time it occurred.