FREXT 50 MG TABLET

Name

• Brand Name: FREXT 50 MG TABLET
• Common Name: Fluvoxamine (flu-VOX-uh-meen MAL-ee-ate)

Composition

Each tablet contains 50 mg of Fluvoxamine, which belongs to the class of selective serotonin reuptake inhibitors (SSRIs).

Uses

FREXT 50 MG TABLET is primarily prescribed for the management and alleviation of symptoms associated with:

• Obsessive-compulsive disorder (OCD)
• Depression (Major Depressive Disorder)
• Anxiety disorders, including panic disorder and social anxiety disorder
• Post-traumatic stress disorder (PTSD)
• Premenstrual dysphoric disorder (PMDD)

Dosage and Administration

• Typical Starting Dosage for Adults: 50 mg orally, as a single dose at bedtime.
• Usual Range: 100 to 300 mg/day.
• Dosage Adjustments: The dose may be increased in 50 mg increments every 4 to 7 days, as tolerated, until the maximum therapeutic benefit is achieved (up to 300 mg/day).
• Divided Doses: Total daily doses greater than 100 mg should be given in two divided doses; if doses are unequal, the larger dose should be given at bedtime.
• Administration: Can be taken with or without food. Swallow the tablet whole with water; do not crush, chew, or break it.
• Consistency: Take the medicine regularly at the same time each day for optimal benefit.
• Do not stop abruptly: Do not change the dose or stop taking it without consulting a doctor, as abrupt discontinuation can lead to withdrawal symptoms.

Side Effects

Common Side Effects:

• Nausea, vomiting, diarrhea, constipation, indigestion, dry mouth
• Headache, dizziness, drowsiness, insomnia (difficulty sleeping), nervousness, tremor, agitation, anxiety
• Increased sweating
• Decreased libido, abnormal ejaculation, erectile dysfunction
• Loss of appetite
• Fatigue, asthenia

Serious Side Effects (seek immediate medical attention if experienced):

• Serotonin syndrome (symptoms include sweating, muscle spasms, instability, confusion, extreme agitation, stiff muscles, high temperature, hallucinations, high heart rate, high blood pressure)
• Increased suicidal thoughts or behavioral changes
• Cardiac irregularities (palpitations)
• Seizures
• Unusual bruising or bleeding
• Severe skin reactions (rash, hives)

Precautions

• Allergies: Do not take if allergic to fluvoxamine or other ingredients.
• MAOIs: Do not use within 14 days of starting or stopping Monoamine Oxidase Inhibitors (MAOIs). After stopping fluvoxamine, wait at least 2 weeks before starting an MAOI.
• Cisapride: Contraindicated with cisapride due to increased risk of QT prolongation and serious heart rhythm issues.
• Alcohol: Avoid alcohol consumption as it can increase sedative effects like drowsiness and dizziness.
• Smoking: Smoking increases the metabolism of fluvoxamine, which may require dose adjustment.
• Other Medications: Inform your doctor about all medications and supplements being taken, especially lithium, tryptophan, warfarin, clozapine, tricyclic antidepressants, benzodiazepines, carbamazepine, methadone, metoprolol, propranolol, and NSAIDs, as plasma levels of these drugs may be increased or interactions can occur.
• Medical Conditions: Use with caution in patients with liver or kidney problems, a history of seizures, bipolar disorder (may activate hypomania or mania), low sodium levels, increased risk of bleeding, glaucoma, or a family history of depressive disorder.
• Pregnancy and Breastfeeding: Use with caution during pregnancy (Category C) and breastfeeding as it is excreted in breast milk. Consult your doctor.
• Cognitive and Motor Performance: May cause dizziness and sleepiness; caution is advised when operating hazardous machinery or driving.
• Children and Adolescents: Safety and efficacy in patients under 18 years for depression have not been established. Use for OCD in children under 8 years is not recommended.

Storage

Store at room temperature. Protect from light and humidity. Keep away from the reach of children.

What is FREXT 50 MG TABLET used for?

FREXT 50 MG TABLET is primarily used to manage and alleviate symptoms associated with depression and various anxiety disorders. This includes major depressive disorder, obsessive-compulsive disorder (OCD), panic disorder, social anxiety disorder, and premenstrual dysphoric disorder (PMDD).

How does FREXT 50 MG TABLET work?

FREXT 50 MG TABLET contains fluvoxamine, which belongs to a class of drugs called Selective Serotonin Reuptake Inhibitors (SSRIs). It works by increasing the levels of serotonin, a natural chemical messenger (neurotransmitter) in the brain. Serotonin plays a crucial role in regulating mood, emotions, sleep, appetite, and overall mental well-being. By preventing the reabsorption of serotonin back into nerve cells, FREXT 50 MG TABLET prolongs its availability, leading to improved mood and reduced anxiety.

What is the usual dosage of FREXT 50 MG TABLET?

For adults, the usual starting dose is 50 mg taken once daily, often at bedtime. Your doctor may gradually increase the dose in 50 mg increments every 4 to 7 days, as tolerated, until the maximum therapeutic benefit is achieved. The maximum recommended daily dose is typically 300 mg. If the total daily dose exceeds 100 mg, it is usually divided into two doses, with the larger dose taken at bedtime. Always follow your doctor's specific instructions.

What are the possible side effects of FREXT 50 MG TABLET?

Common side effects may include nausea, dry mouth, constipation, dizziness, drowsiness, insomnia (difficulty sleeping), increased sweating, blurred vision, fatigue, loss of appetite, nervousness, tremors, and sexual dysfunction (such as decreased libido, erectile dysfunction, or delayed ejaculation). These are usually mild and temporary. More serious but less common side effects can include serotonin syndrome or an increase in suicidal thoughts, which require immediate medical attention.

Is FREXT 50 MG TABLET safe during pregnancy or breastfeeding?

Pregnancy: FREXT 50 MG TABLET is generally not recommended during pregnancy, especially in the third trimester. It may pose potential risks to the unborn baby, including persistent pulmonary hypertension, withdrawal effects in the newborn, premature birth, and weight changes in the baby. It should only be used if your doctor determines that the potential benefits clearly outweigh the risks. Breastfeeding: Use with caution during breastfeeding. While some studies suggest undetectable amounts of fluvoxamine may pass into breast milk, it is crucial to consult your doctor to weigh the potential benefits and risks before taking this medication while nursing.

Can FREXT 50 MG TABLET be taken with other medications?

FREXT 50 MG TABLET can interact with numerous other medications. It is critical to inform your doctor about all prescription drugs, over-the-counter medications, supplements, and herbal products you are taking. Severe interactions can occur with:

• Monoamine Oxidase Inhibitors (MAOIs): Concurrent use can lead to a life-threatening condition called serotonin syndrome. A waiting period of at least 14 days is required between stopping an MAOI and starting FREXT, and vice versa.
• Other Antidepressants: (e.g., other SSRIs, SNRIs, tricyclic antidepressants, triptans) can also increase serotonin levels and risk serotonin syndrome.
• Blood Thinners: (e.g., warfarin, aspirin, NSAIDs) may increase the risk of bleeding.
• Certain other medications: Such as benzodiazepines (e.g., alprazolam, diazepam), lithium, tryptophan, methadone, mexiletine, and cisapride.

What precautions should be taken while using FREXT 50 MG TABLET?

• Alcohol: Avoid consuming alcohol as it can increase the sedative effects of the medication and worsen side effects like dizziness and drowsiness.
• Driving and Machinery: This medicine may cause dizziness or drowsiness; therefore, avoid driving or operating heavy machinery until you understand how it affects you.
• Discontinuation: Do not stop taking FREXT 50 MG TABLET abruptly without consulting your doctor, even if you feel better. Sudden discontinuation can lead to withdrawal symptoms such as anxiety, restlessness, palpitations, dizziness, and sleep disturbances. Your doctor will guide you on a gradual dose reduction.
• Medical Conditions: Inform your doctor if you have liver or kidney problems, a history of seizures, bipolar disorder, glaucoma, low sodium levels in the blood, or an increased risk of bleeding.
• Suicidal Thoughts: Close monitoring for suicidal thoughts and behavioral changes is recommended, especially in children, adolescents, and young adults starting antidepressant therapy.
• Caffeine: Avoid excessive caffeine intake as it can worsen symptoms like anxiety or sleep disturbances.

What happens if a dose of FREXT 50 MG TABLET is missed?

If you miss a dose, take it as soon as you remember. However, if it is almost time for your next scheduled dose, skip the missed dose and continue with your regular dosing schedule. Do not double the dose to make up for a missed one.

How should FREXT 50 MG TABLET be stored?

FREXT 50 MG TABLET should be stored at room temperature, away from moisture and heat. Keep the medication in its original container, tightly closed, and out of reach of children and pets. Protect it from light and humidity.