Fluoxetine 10mg Tablets

Fluoxetine is a selective serotonin reuptake inhibitor (SSRI). It potently and selectively inhibits the reuptake of serotonin (5-HT) into presynaptic neurons in the central nervous system (CNS). This leads to an increased concentration of serotonin in the synaptic cleft, enhancing serotonergic neurotransmission. Fluoxetine has minimal affinity for other neurotransmitter receptors (e.g., alpha-adrenergic, beta-adrenergic, dopaminergic, histaminergic, muscarinic, GABAergic receptors).

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, such as:
+ 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
+ Swelling of the mouth, face, lips, tongue, or throat
Signs of low sodium levels, including:
+ Headache
+ Trouble focusing
+ Memory problems
+ Feeling confused
+ Weakness
+ Seizures
+ Changes in balance
Sudden and significant weight gain or loss
Seizures
Dizziness
Slow heartbeat
Unexplained bruising or bleeding
Anxiety
Unusual thirst
Changes in menstrual period
Increased urination
Trouble controlling body movements
Joint pain
Swollen glands
Painful erection (lasting more than 4 hours) or prolonged erection
Sex problems, such as:
+ Decreased interest in sex
+ Trouble having an orgasm
+ Ejaculation problems
+ Difficulty getting or maintaining an erection

If you experience any of these symptoms, consult your doctor. They can help you manage these side effects and provide guidance on what to do next.

Serious but Rare Side Effects

A potentially life-threatening condition called serotonin syndrome may occur, especially if you're taking other medications. Seek medical help immediately if you experience:

Agitation
Changes in balance
Confusion
Hallucinations
Fever
Fast or abnormal heartbeat
Flushing
Muscle twitching or stiffness
Seizures
Shivering or shaking
Excessive sweating
Severe diarrhea, stomach upset, or vomiting
Severe headache

Additionally, this medication may cause a type of abnormal heartbeat (prolonged QT interval), which can lead to another type of unsafe abnormal heartbeat (torsades de pointes). If you experience a fast or abnormal heartbeat, or if you pass out, contact your doctor right away.

Other Possible Side Effects

Like all medications, this drug can cause side effects. While many people may not experience any side effects or only minor ones, it's essential to monitor your body's response. If you notice any of the following side effects, consult your doctor or seek medical attention if they bother you or persist:

Constipation
Diarrhea
Upset stomach
Vomiting
Decreased appetite
Dry mouth
Drowsiness
Strange or vivid dreams
Sleep disturbances
Fatigue or weakness
Flu-like symptoms
Yawning
Hot flashes
Nervousness or excitability
Shakiness
Excessive sweating
Headache
* Nose or throat irritation

This is not an exhaustive list of possible side effects. If you have questions or concerns, 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:

Any allergies you have, including allergies to this medication, its components, or other substances. Be sure to describe the allergic reaction you experienced.
If you are currently taking or have recently taken any of the following medications:
+ Linezolid
+ Methylene blue
+ Pimozide
+ Thioridazine
If you have taken any medications for depression or Parkinson's disease within the last 14 days, including:
+ Isocarboxazid
+ Phenelzine
+ Tranylcypromine
+ Selegiline
+ Rasagiline, as this may increase the risk of very high blood pressure
If you are taking any medications that can cause abnormal heart rhythms (prolonged QT interval). There are many medications that can cause this condition, so it is crucial to consult with your doctor or pharmacist if you are unsure.

To ensure your safety, it is vital to disclose all of your medications, including:

Prescription medications
Over-the-counter (OTC) medications
Natural products
Vitamins

Additionally, inform your doctor about any existing health problems. This information will help your doctor determine whether it is safe for you to take this medication with your other medications and health conditions. Never start, stop, or change the dosage 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. This will help ensure your safety and prevent potential interactions with other treatments.

Until you know how this medication affects you, avoid driving and other activities that require alertness. If you need to stop taking this medication, do not do so abruptly without consulting your doctor, as this may increase your risk of side effects. Instead, your doctor will guide you on how to gradually taper off the medication.

While taking this medication, it is recommended that you avoid consuming alcohol. Additionally, before using marijuana, cannabis, or any prescription or over-the-counter drugs that may cause drowsiness, discuss the potential risks with your doctor.

If you have diabetes, it is crucial to closely monitor your blood sugar levels, as this medication may affect them. Be aware that it may take several weeks to experience the full effects of the medication.

There is a potential risk of bleeding associated with this medication, which can be life-threatening in some cases. Discuss this risk with your doctor. Rarely, severe and potentially life-threatening reactions, including lung, kidney, or liver problems, have occurred in people taking this medication. Seek immediate medical attention if you experience any of the following symptoms: changes in urine output, dark urine, decreased appetite, stomach pain or upset, light-colored stools, vomiting, yellowing of the skin or eyes, or shortness of breath.

Some individuals may be at a higher risk of developing eye problems while taking this medication. Your doctor may recommend an eye exam to assess this risk. If you experience eye pain, changes in vision, or swelling and redness around the eye, contact your doctor promptly.

This medication can cause low sodium levels, which can be life-threatening and lead to seizures, loss of consciousness, breathing difficulties, or death. Children and adolescents taking this medication may require regular growth checks, as it can affect growth in some cases. Discuss this with your doctor.

If you are 65 or older, use this medication with caution, as you may be more susceptible to side effects. Inform your doctor if you are pregnant, plan to become pregnant, or are breastfeeding. 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 help you weigh the benefits and risks of taking this medication during pregnancy and breastfeeding.

• Monoamine Oxidase Inhibitors (MAOIs) (risk of serotonin syndrome)
• Pimozide (risk of QT prolongation)
• Thioridazine (risk of QT prolongation and sudden death)

• Other serotonergic drugs (e.g., triptans, tricyclic antidepressants, fentanyl, lithium, tramadol, tryptophan, buspirone, St. John's Wort) - increased risk of serotonin syndrome.
• Drugs that prolong the QT interval (e.g., Class IA and III antiarrhythmics, antipsychotics, macrolide antibiotics) - increased risk of QT prolongation.
• Drugs metabolized by CYP2D6 (e.g., tricyclic antidepressants, atomoxetine, risperidone, metoprolol, flecainide, propafenone) - fluoxetine is a potent CYP2D6 inhibitor, leading to increased plasma concentrations of these drugs.
• Warfarin and other anticoagulants/antiplatelets (e.g., NSAIDs, aspirin) - increased risk of bleeding.

• Benzodiazepines (e.g., alprazolam, diazepam) - altered metabolism, potential for increased benzodiazepine levels.
• Phenytoin - altered metabolism, potential for increased phenytoin levels.
• Carbamazepine - altered metabolism, potential for increased carbamazepine levels.
• Clozapine - increased clozapine levels and risk of adverse effects.
• Alcohol - additive CNS depressant effects, though specific interaction is not well-defined.

• Not available

• Worsening depression
• Suicidal thoughts or behavior
• Unusual changes in behavior (e.g., agitation, irritability, hostility, impulsivity, akathisia)
• Mania or hypomania
• Anxiety
• Panic attacks
• Insomnia
• Nausea, diarrhea
• Headache
• Sexual dysfunction
• Tremor
• Sweating
• Serotonin Syndrome symptoms (e.g., agitation, hallucinations, rapid heart rate, fever, sweating, shivering, muscle rigidity, twitching, incoordination, nausea, vomiting, diarrhea)
• Bleeding or bruising
• Hyponatremia symptoms (e.g., headache, difficulty concentrating, memory impairment, confusion, weakness, unsteadiness, seizures, hallucinations, fainting)

Use during pregnancy should be carefully considered, balancing potential risks and benefits. Exposure during the first trimester may be associated with a small increased risk of cardiovascular malformations. Exposure late in the third trimester has been associated with persistent pulmonary hypertension of the newborn (PPHN) and neonatal withdrawal symptoms (e.g., respiratory distress, feeding difficulties, irritability, tremor).

Fluoxetine and its active metabolite, norfluoxetine, are excreted into breast milk. While some infants may experience no adverse effects, others may experience irritability, poor feeding, drowsiness, or weight loss. Monitor breastfed infants for adverse effects. Consider alternative agents with less infant exposure or shorter half-lives if possible, or monitor infant closely.

Fluoxetine is approved for Major Depressive Disorder in children 8 years and older, and for OCD in children 7 years and older. A Black Box Warning exists regarding increased risk of suicidal thoughts and behavior in children, adolescents, and young adults. Close monitoring is essential. Lower starting doses and careful titration are often used.

Use with caution in elderly patients. They may be more sensitive to the effects of fluoxetine, including hyponatremia and CNS side effects (e.g., dizziness, falls). Lower starting doses and slower titration are recommended. Monitor for drug interactions, especially with other medications metabolized by CYP2D6.

• Fluoxetine has a very long half-life (especially its active metabolite, norfluoxetine), meaning it takes a long time to reach steady state and to be eliminated from the body. This can be beneficial for adherence (less severe withdrawal if a dose is missed) but also means side effects or drug interactions can persist for weeks after discontinuation.
• Due to its long half-life, a 'washout' period of at least 5 weeks (or longer, up to 7 weeks, especially if high doses or hepatic impairment) is required before starting an MAOI to prevent serotonin syndrome.
• Fluoxetine is a potent inhibitor of CYP2D6, which can significantly impact the metabolism of other drugs, including many antidepressants, antipsychotics, beta-blockers, and opioids.
• It is one of the few SSRIs approved for bulimia nervosa.
• The 10mg tablet is useful for starting doses, dose titration, and for specific indications like PMDD (intermittent dosing) or in sensitive patients (e.g., elderly, hepatic impairment).

• Other SSRIs (e.g., Sertraline, Escitalopram, Citalopram, Paroxetine, Fluvoxamine)
• SNRIs (e.g., Venlafaxine, Duloxetine, Desvenlafaxine)
• Atypical Antidepressants (e.g., Bupropion, Mirtazapine, Trazodone)
• Tricyclic Antidepressants (TCAs)
• MAOIs (e.g., Phenelzine, Tranylcypromine, Selegiline)
• Psychotherapy (e.g., Cognitive Behavioral Therapy - CBT)
• Electroconvulsive Therapy (ECT) for severe depression

If your symptoms or health issues persist or worsen, it's essential to contact your doctor promptly. To ensure safe use, never share your medication with others or take someone else's medication. This medication is accompanied by a Medication Guide, which provides crucial information for patients. Please read this guide carefully and review it again whenever you receive a refill. If you have any questions or concerns about this medication, don't hesitate to consult your doctor, pharmacist, or other healthcare provider. In the event of a suspected overdose, immediately call your local poison control center or seek emergency medical attention. When reporting the incident, be prepared to provide details about the medication taken, the quantity, and the time it occurred.