Introduction

Oxetin Capsule 20 mg is a selective serotonin reuptake inhibitor (SSRI) used primarily to treat major depressive disorder (MDD), obsessive-compulsive disorder (OCD), bulimia nervosa, and panic disorder. It is marketed under various brand names, including Prozac. Fluoxetine works by increasing serotonin levels in the brain, which helps improve mood and reduce anxiety.

Uses

Oxetin Capsule 20 mg is indicated for:

  • Treatment of major depressive disorder in adults and pediatric patients aged 8 years and older.
  • Treatment of obsessive-compulsive disorder in adults and pediatric patients aged 7 years and older.
  • Treatment of bulimia nervosa in adults.
  • Treatment of panic disorder in adults.
  • In some cases, it may be prescribed off-label for conditions such as premenstrual dysphoric disorder (PMDD) and generalized anxiety disorder (GAD).
It is commonly used as part of a comprehensive treatment plan that includes psychotherapy and lifestyle modifications.

Brand Name Oxetin
Type Capsule
Weight 20 mg
Generic Fluoxetine Hydrochloride
Manufacturer Decent Pharma Laboratories Ltd.
Available in English বাংলা

Mechanism of Action

Oxetin Capsule 20 mg works by inhibiting the reuptake of serotonin in the brain. This increases the levels of serotonin, a neurotransmitter associated with mood regulation. By enhancing serotonin availability, Fluoxetine helps improve mood and reduce symptoms of depression and anxiety.

How Long Does It Take to Work?

Fluoxetine can take several weeks to show its full therapeutic effects. Initial improvements in symptoms may be noticed within 1-2 weeks of starting the medication, but it generally takes 4-6 weeks to achieve optimal therapeutic benefits.

Absorption

Fluoxetine is well-absorbed from the gastrointestinal tract. Peak plasma concentrations are typically reached within 6-8 hours after oral administration. The absolute bioavailability of Fluoxetine is approximately 72%, which can be affected by food and other factors.

Route of Elimination

Fluoxetine is primarily metabolized in the liver and excreted via the urine. The drug is metabolized to several active metabolites, including norfluoxetine, which also has antidepressant activity. A smaller portion is eliminated in the feces.

Dosage

Initial treatment: Recent studies suggest that 20 mg/day of Fluoxetine may be sufficient to obtain satisfactory antidepressant response. Consequently, a dose of 20 mg/day administered in the morning is recommended as the initial dose.

A dose increase may be considered after several weeks if no clinical improvement is observed. Dosage above 20 mg/day, should be administered on a bid schedule (i.e. morning and noon) and should not exceed a maximum dose of 80 mg/day. As with other antidepressants, the full antidepressant effect may be delayed until 4 weeks of treatment or longer. As with many other medications, a lower or less frequent dosage should be used in patients with renal and/or hepatic impairment.

A lower or less frequent dosage should also be considered for patients, such as elderly, with concurrent disease or on multiple medication. A recommended maximum dose for elderly patients is 60 mg per day.

Maintenance treatment: It is generally agreed among expert psychopharmacologists that acute episode of depression requires several months or longer sustained pharmacologic therapy. Fluoxetine is also used in dosage of 60 mg daily for the management of bulimia nervosa.

Use in children: The use of Fluoxetine in children is not recommended as safety and efficacy have not been established.

The dosage of Fluoxetine depends on the condition being treated and individual patient factors. Typical dosages include:

  • For major depressive disorder: 20 mg once daily, which can be increased to 40-60 mg per day based on response and tolerability.
  • For obsessive-compulsive disorder: 20 mg once daily, with a possible increase to 60 mg per day.
  • For bulimia nervosa: 60 mg once daily.
  • For panic disorder: 10 mg once daily, with a possible increase to 40 mg per day.
Dosage adjustments may be necessary for patients with liver impairment or other medical conditions. Always follow the prescribing healthcare provider’s instructions.

Administration

Fluoxetine is administered orally, typically as a capsule or tablet. It can be taken with or without food. For consistency, it should be taken at the same time each day. The medication should be swallowed whole and not crushed or chewed.

Side Effects

Common side effects of Fluoxetine include:

  • Nausea
  • Headache
  • Insomnia
  • Diarrhea
  • Dry mouth
  • Fatigue
  • Sexual dysfunction
Serious side effects can include suicidal thoughts or behavior, serotonin syndrome, and severe allergic reactions. Regular monitoring for these effects is recommended.

Toxicity

Signs of Fluoxetine toxicity may include severe nausea, vomiting, agitation, hallucinations, rapid heartbeat, and seizures. In case of overdose, immediate medical attention is necessary. Treatment may include supportive care and monitoring for symptoms of serotonin syndrome or other complications.

Precautions

Fluoxetine should be used with caution in patients with a history of bipolar disorder, liver impairment, seizure disorders, or a history of suicidal thoughts or behavior. Regular monitoring for mood changes and other adverse effects is essential. Patients should be advised to report any unusual symptoms promptly.

Interaction

Fluoxetine may interact with other medications, particularly those affecting serotonin levels or liver enzymes. It is important to inform healthcare providers of all medications being taken, including over-the-counter drugs and supplements, to avoid potential interactions.

Disease Interaction

Fluoxetine should be used with caution in patients with liver disease, bipolar disorder, or a history of seizures. Dose adjustments and regular monitoring may be necessary for these conditions.

Drug Interaction

Fluoxetine may interact with other drugs such as monoamine oxidase inhibitors (MAOIs), other SSRIs, and certain antipsychotics. Combining Fluoxetine with these medications can increase the risk of serotonin syndrome. Caution is advised when using Fluoxetine with drugs that affect serotonin levels or liver metabolism.

Food Interactions

Food does not significantly affect the absorption of Fluoxetine. However, taking Fluoxetine with food may help minimize gastrointestinal side effects. Patients should follow their healthcare provider's recommendations regarding food and drug interactions.

Pregnancy Use

Fluoxetine is classified as Category C for pregnancy, indicating that risk cannot be ruled out. It should only be used during pregnancy if the potential benefits outweigh the risks. Pregnant women should discuss the risks and benefits with their healthcare provider.

Lactation Use

Fluoxetine is excreted in breast milk, and its use during lactation is generally not recommended unless the benefits outweigh the risks. Nursing mothers should consult their healthcare provider to determine the best course of action for both mother and infant.

Acute Overdose

Acute overdose of Fluoxetine may lead to symptoms such as agitation, hallucinations, seizures, and rapid heartbeat. Immediate medical attention is necessary for managing overdose and mitigating potential adverse effects.

Contraindication

Fluoxetine is contraindicated in patients with a known hypersensitivity to the drug or its components. It should not be used in conjunction with MAOIs or within 14 days of discontinuing MAOIs due to the risk of serotonin syndrome.

Use Direction

Patients should adhere to the prescribed dosage and administration instructions provided by their healthcare provider. Consistency in taking the medication and regular follow-up appointments are essential for effective management and monitoring of treatment outcomes.

Storage Conditions

Fluoxetine should be stored at room temperature, away from moisture and heat. The medication should be kept in its original container and out of reach of children. Unused or expired medication should be disposed of according to local regulations.

Volume of Distribution

The volume of distribution for Fluoxetine is approximately 20-40 L, indicating that the drug is distributed throughout the body’s tissues and fluids.

Half Life

The half-life of Fluoxetine is approximately 4-6 days, while its active metabolite, norfluoxetine, has a half-life of about 7-15 days. This long half-life allows for once-daily dosing.

Clearance

Fluoxetine is primarily cleared through the liver, with its metabolites excreted in the urine. The clearance rate can be affected by liver function and other medical conditions. Dose adjustments may be necessary for patients with hepatic impairment.

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