Desvenlafaxine ER Tabs 50mg

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 into presynaptic neurons. This leads to increased concentrations of these neurotransmitters in the synaptic cleft, which is thought to contribute to 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 immediate medical attention:

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, difficulty focusing, memory problems, confusion, 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 real).
Sex-related problems, including decreased interest in sex, difficulty having an orgasm, ejaculation problems, or trouble achieving or maintaining an erection. If you have concerns, discuss them with your doctor.
A potentially life-threatening condition called serotonin syndrome may occur, especially if you are taking certain other medications. Seek immediate medical attention if you experience agitation, changes in balance, confusion, hallucinations, fever, rapid or abnormal heartbeat, flushing, muscle twitching or stiffness, seizures, shivering or shaking, excessive sweating, severe diarrhea, stomach upset, or vomiting, or a severe headache.

Other Possible Side Effects

Like all medications, this drug can cause side effects. Many people may not experience any side effects or may only have mild ones. If you are bothered by any of the following side effects or if they persist, contact your doctor or seek medical attention:

Dizziness, drowsiness, fatigue, or weakness.
Upset stomach 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, contact 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, to your doctor and pharmacist. This will help determine the safety of taking this medication with your other treatments. 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, such as standing up from a sitting or lying down position, do so slowly 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 experiencing side effects, which can be severe and long-lasting. If you need to discontinue this medication, your doctor will provide guidance on how to gradually stop taking it. If you experience any new or worsening symptoms, discuss them with your doctor promptly.

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 medication. Before using marijuana, cannabis, or other prescription or over-the-counter medications that may cause drowsiness, 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. Some individuals may have a higher risk of developing eye problems while taking this medication. Your doctor may recommend an eye examination to assess your risk. If you experience eye pain, changes in vision, or swelling and redness in or around the eye, contact your doctor immediately.

This medication may cause low blood sodium levels, which can be fatal in severe cases. Discuss this risk with your doctor. Additionally, high cholesterol has been reported in individuals taking this medication. If you have concerns, consult with your doctor.

This medication may affect the results of certain laboratory tests. Inform all your healthcare providers and laboratory personnel that you are taking this medication. If you notice what appears to be a tablet in your stool, do not be alarmed, as this is a normal occurrence and not a cause for concern. If you have questions, discuss them with your doctor.

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

• Monoamine Oxidase Inhibitors (MAOIs): Concomitant use or within 14 days of discontinuing an MAOI, or initiating an MAOI within 7 days of discontinuing desvenlafaxine, due to risk of serotonin syndrome.

• Other serotonergic drugs (e.g., SSRIs, other SNRIs, triptans, fentanyl, lithium, tramadol, tryptophan, buspirone, St. John's Wort): Increased risk of serotonin syndrome.
• Anticoagulants (e.g., warfarin) and antiplatelet agents (e.g., aspirin, NSAIDs): Increased risk of bleeding, including gastrointestinal bleeding.

• Drugs that increase blood pressure or heart rate (e.g., sympathomimetics): Potential for additive effects.
• Alcohol: May potentiate CNS effects and increase risk of liver toxicity (though desvenlafaxine metabolism is not hepatic CYP-dependent, general caution with CNS depressants).

• Not many specific minor interactions due to minimal CYP450 metabolism.

• Serotonin Syndrome (agitation, hallucinations, delirium, coma, tachycardia, labile blood pressure, dizziness, diaphoresis, flushing, hyperthermia, tremor, rigidity, myoclonus, hyperreflexia, incoordination, nausea, vomiting, diarrhea)
• Withdrawal Symptoms (dizziness, nausea, headache, irritability, insomnia, anxiety, paresthesia, fatigue, flu-like symptoms) upon abrupt discontinuation
• Worsening depression or emergence of suicidal thoughts/behavior
• Unusual bleeding or bruising
• New or worsening hypertension
• Signs of hyponatremia (headache, difficulty concentrating, memory impairment, confusion, weakness, unsteadiness, falls; severe: hallucinations, syncope, seizures, coma, respiratory arrest)

Use during pregnancy should only be considered if the potential benefit justifies the potential risk to the fetus. Exposure during the third trimester may lead to complications in the neonate, including withdrawal symptoms and persistent pulmonary hypertension of the newborn (PPHN).

Desvenlafaxine is excreted into breast 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 the drug or from the underlying maternal condition.

Safety and efficacy have not been established in pediatric patients. Antidepressants, including desvenlafaxine, increase the risk of suicidal thoughts and behavior in children, adolescents, and young adults (aged 18-24) compared to placebo in short-term studies.

No overall differences in safety or effectiveness were observed between geriatric 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 based on renal function, which often declines with age.

• Desvenlafaxine is the major active metabolite of venlafaxine, but it has a more favorable pharmacokinetic profile (longer half-life, less CYP interaction).
• The extended-release tablet should be swallowed whole; do not crush, chew, or divide. The tablet shell may be excreted in the stool, which is normal and does not mean the medication was not absorbed.
• Due to its minimal CYP450 metabolism, desvenlafaxine may be a preferred SNRI for patients on multiple medications with potential CYP interactions.
• Abrupt discontinuation can lead to significant withdrawal symptoms (discontinuation syndrome); taper dose gradually over at least 1-2 weeks, or longer if symptoms emerge.
• Monitor blood pressure regularly, especially during initial treatment and dose increases, as dose-dependent increases in blood pressure can occur.
• Consider baseline and periodic serum sodium monitoring, particularly in elderly patients or those at risk for hyponatremia.

• Other SNRIs (e.g., venlafaxine, duloxetine, levomilnacipran)
• SSRIs (e.g., escitalopram, sertraline, fluoxetine, paroxetine, citalopram)
• Atypical antidepressants (e.g., bupropion, mirtazapine, vortioxetine, vilazodone)
• Tricyclic Antidepressants (TCAs) (e.g., amitriptyline, nortriptyline)
• Psychotherapy (e.g., Cognitive Behavioral Therapy - CBT)

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 consumed, and the time it occurred.