Fluvoxin 50 Mg Tablet (10 Tab)

FLUVOXIN 50 MG TABLET is an antidepressant medication manufactured by SUN PHARMA LABORATORIES LTD., primarily used for the management of various neurological and mental health conditions.

Name

• Brand Name: FLUVOXIN 50 MG TABLET
• Common Name: Fluvoxamine (as Fluvoxamine Maleate)

Composition

Each tablet contains Fluvoxamine Maleate equivalent to 50 mg of Fluvoxamine.

Uses

FLUVOXIN 50 MG TABLET is prescribed for the treatment of:

• Depression (Major Depressive Disorder)
• Obsessive-Compulsive Disorder (OCD)
• Anxiety
• Panic Disorder/Panic Attacks
• Social Anxiety Disorder (Social Phobia)

Dosage and Administration

FLUVOXIN 50 MG TABLET is for oral administration and can be taken with or without food, typically once daily at bedtime.

• Adults (Depression): The usual starting dose ranges from 50 mg to 100 mg daily, which may be increased up to a maximum of 300 mg daily. If the daily dose exceeds 150 mg, it should be divided into 2 or 3 doses.
• Adults (OCD): The initial dose is 50 mg once daily, and it may be increased by 50 mg every 4-7 days, with a maximum dose of 300 mg per day.
• Children (OCD, 8 years and older): An initial dose of 25 mg once daily is recommended, which can be increased by 25 mg every 4-7 days, up to a maximum of 200 mg daily.

The tablet should be swallowed whole with a glass of water and not chewed, crushed, or broken. Do not stop the medication abruptly; the dosage should be gradually reduced under medical supervision to avoid withdrawal symptoms.

Side Effects

• Common Side Effects: Nausea, vomiting, drowsiness, dizziness, fatigue, dry mouth, increased sweating, tremors, insomnia (difficulty sleeping), loss of appetite, indigestion, restlessness, nervousness, delayed ejaculation, erectile dysfunction, low sexual desire, constipation, diarrhea, headache, anxiety, agitation, muscle weakness, blurred vision, changes in taste, muscle pain, yawning, sore throat, heavy menstrual periods, sexual problems, dyspepsia, and abdominal pain.
• Serious Side Effects: Include an increased risk of suicidal thoughts and behaviors (especially in children, adolescents, and young adults), serotonin syndrome (characterized by symptoms like hallucinations, high heart rate, high blood pressure, confusion, excessive sweating, seizures, muscle spasms, instability, and extreme agitation), bleeding problems, convulsions (seizures), mania/hypomania, angle-closure glaucoma, low sodium levels in the blood (hyponatremia), stiff muscles, and high temperature.

Precautions

• Contraindications: FLUVOXIN 50 MG TABLET should not be taken by individuals with a known hypersensitivity to fluvoxamine or any other ingredients in the medicine.
• Drug Interactions: It is contraindicated with Monoamine Oxidase Inhibitors (MAOIs) or within 14 days of stopping an MAOI due to the risk of serotonin syndrome. Co-administration with tizanidine, thioridazine, alosetron, or pimozide is also contraindicated. Caution is advised when used with other serotonergic agents (e.g., triptans, lithium, tramadol), benzodiazepines, tricyclic antidepressants, neuroleptics, St. John's Wort, aspirin/NSAIDs, ciclosporin, methadone, and mexiletine.
• Medical Conditions: Use with caution in patients with liver or kidney problems, low sodium levels, increased risk of bleeding, history of suicidal thoughts, family history of depressive disorder, intestinal ulcer, glaucoma, epilepsy (seizures), diabetes, mania, or bipolar disorder.
• Pregnancy and Breastfeeding: Consult a doctor if pregnant, planning pregnancy, or breastfeeding, as the medicine may harm the unborn baby and is likely unsafe during breastfeeding.
• Alcohol and Caffeine: Avoid alcohol as it can increase dizziness and drowsiness. Caffeine intake should also be avoided as it can worsen symptoms.
• Activities Requiring Alertness: This medicine may cause drowsiness and dizziness; therefore, avoid driving or operating heavy machinery until you understand how it affects you.
• Pediatric Use: Not recommended for children under 18 years for depression. For OCD, it is not recommended for children below 8 years of age.

Storage

Store FLUVOXIN 50 MG TABLET at room temperature (below 30°C or 25°C), protected from light and moisture. Keep out of the sight and reach of children.

FLUVOXIN 50 MG TABLET contains Fluvoxamine, an antidepressant belonging to the selective serotonin reuptake inhibitor (SSRI) class of medicines. It is primarily used to treat certain mental health conditions.

What is FLUVOXIN 50 MG TABLET used for?

FLUVOXIN 50 MG TABLET is primarily used to treat obsessive-compulsive disorder (OCD), which involves bothersome thoughts and repetitive actions. It is also prescribed for depression, anxiety, panic disorder, and social anxiety disorder.

How does FLUVOXIN 50 MG TABLET work?

FLUVOXIN 50 MG TABLET is a selective serotonin reuptake inhibitor (SSRI). It works by increasing the levels of serotonin, a natural chemical messenger in the brain. By boosting serotonin levels, it helps improve mood, cognition, memory, and can relieve symptoms associated with depression, anxiety, and obsessive-compulsive disorders.

What is the usual dosage of FLUVOXIN 50 MG TABLET?

For adults, the typical starting dose for obsessive-compulsive disorder (OCD) is 50 mg once a day at bedtime. Your doctor may gradually adjust the dose as needed, up to a maximum of 300 mg per day. If the daily dose is higher than 100 mg, it may be divided into two doses. For children aged 8 to 17 years with OCD, the starting dose is usually 25 mg once a day at bedtime, with a maximum dose of 200 mg per day. Doses over 50 mg daily for children may also be given in two divided doses.

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

Common side effects can include drowsiness, dry mouth, nausea, vomiting, diarrhea, stomach pain, constipation, decreased appetite, sweating, difficulty sleeping, nervousness, and changes in sex drive or performance. Serious side effects, though less common, can include suicidal thoughts or tendencies (especially in children, teenagers, and young adults), serotonin syndrome (symptoms like agitation, hallucinations, rapid heartbeat, confusion, sweating, muscle stiffness, or twitching), severe allergic reactions (rash, hives, swelling), unusual bleeding, low sodium levels, seizures, and eye problems like angle-closure glaucoma.

Is it safe during pregnancy or breastfeeding?

It is generally advised not to use FLUVOXIN 50 MG TABLET during pregnancy or breastfeeding unless specifically instructed by a doctor. If taken during the third trimester of pregnancy, infants may be at risk for complications requiring prolonged hospitalization, respiratory support, and feeding difficulties. The active ingredient, fluvoxamine, passes into breast milk, and while some studies suggest minimal infant exposure and no adverse effects, more comprehensive research is warranted to confirm long-term safety. Your doctor will weigh the potential benefits against the risks.

Can it be taken with other medications?

FLUVOXIN 50 MG TABLET can interact with several medications. It should not be taken with monoamine oxidase inhibitors (MAOIs) or within 14 days of stopping an MAOI, as this can lead to a serious condition called serotonin syndrome. You should also inform your doctor if you are taking other antidepressants, blood thinners (like aspirin, NSAIDs, or warfarin), tizanidine, pimozide, ramelteon, alosetron, or St. John's wort, as these can lead to increased side effects or reduced effectiveness.

What precautions should be taken?

It's crucial to have regular check-ups with your doctor while taking this medicine. Avoid alcohol consumption. Be aware that fluvoxamine may cause drowsiness, dizziness, or blurred vision; therefore, do not drive or operate machinery until you know how the medicine affects you. Patients, especially children, teenagers, and young adults, should be monitored for new or worsening suicidal thoughts or unusual behavior changes, particularly at the start of treatment or during dose adjustments. Do not stop taking FLUVOXIN 50 MG TABLET suddenly, as this can lead to withdrawal symptoms; your doctor will advise on a gradual reduction of the dose.

What happens if a dose is missed?

If you miss a dose of FLUVOXIN 50 MG TABLET, 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 doses to make up for a missed one.

How should it be stored?

Store FLUVOXIN 50 MG TABLET in a closed container at room temperature, away from heat, moisture, and direct light. Keep it from freezing. Always keep this medicine out of the reach of children. Do not keep outdated medicine or medicine no longer needed; consult your healthcare professional on how to dispose of it properly.