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Fluoxetine

INFORMATION FOR USE OF A MEDICALPRACTITIONER
HOSPITAL OR LABORATORY
FLUOXETINE CAPSULE
Available Composition

Each hard gelatin capsules contains: Fluoxetine Hydrochloride BP eq. to Fluoxetine 10 mg

FLUVEXO-20

Each hard gelatin capsules contains: Fluoxetine Hydrochloride BP eq. to Fluoxetine 20 mg

IMPORTANT WARNING:

A small number of children, teenagers, and young adults (up to 24 years of age) who took antidepressants (mood elevators) such as fluoxetine during clinical studies became suicidal (thinking about harming or killing oneself or planning or trying to do so). Children, teenagers, and young adults who take antidepressants to treat depression or other mental illnesses may be more likely to become suicidal than children, teenagers, and young adults who do not take antidepressants to treat these conditions. However, experts are not sure about how great this risk is and how much it should be considered in deciding whether a child or teenager should take an antidepressant.

PHARMACOLOGICAL CLASSIFICATION
Antidepressant
The antidepressant, antiobsessive-compulsive, and antibulimic actions of fluoxetine are presumed to be linked to its inhibition of CNS neuronal uptake of serotonin.

PHARMACOKINETICS

The bioavailability of fluoxetine is relatively high (72%), and peak plasma concentrations are reached in 6 to 8 hours. It is highly bound to plasma proteins, mostly albumin. Fluoxetine is metabolized in the liver by isoenzymes of the cytochrome P450 system, including CYP2D6.Only one metabolite of fluoxetine, norfluoxetine (demethylated fluoxetine), is biologically active. The extremely slow elimination of fluoxetine and its active metabolite norfluoxetine from the body distinguishes it from other antidepressants. With time, fluoxetine and norfluoxetine inhibit their own metabolism, so fluoxetine elimination half-life changes from 1 to 3 days, after a single dose—to 4 to 6 days, after long-term use. Similarly, the half-life of norfluoxetine is longer (16 days) after long-term use.

INDICATIONS

FLUVEXO is indicated for the treatment of:

·          major depression (including pediatric depression),
·          obsessive-compulsive disorder (in both adult and pediatric populations),
·          bulimia nervosa,
·          anorexia nervosa,
·          panic disorder and
·          Premenstrual dysphoric disorder.

PATIENT INFORMATION:

BEFORE YOU TAKE FLUVEXO

Make sure you have told your doctor if you:

Are pregnant or think you may be pregnant, or are planning to become pregnant.
Are breast feeding.
Are allergic to fluoxetine or any other medications.
Are being treated with electroshock therapy
Have recently had a heart attack and if you have or have ever had diabetes, seizures, or liver or heart disease.

HOW TO TAKE FLUVEXO

You must take your medicine as the doctor tells you. It is important to take FLUVEXO Tablets at the right time. Your doctor will decide which is the best dose for you, depending on your illness. The recommended dose for:

Major Depressive Disorder-

Adult – a dose of 20 mg/day, administered in the morning, is recommended as the initial dose

Pediatric (Children and Adolescents)-

Treatment should be initiated with a dose of 10 or 20 mg/day. After 1 week at 10 mg/day, the dose should be increased to 20 mg/day. However, due to higher plasma levels in lower weight children, the starting and target dose in this group may be 10 mg/day. Obsessive Compulsive Disorder-
Adult – a dose of 20 mg/day, administered in the morning, is recommended as the initial dose.
Pediatric (Children and Adolescents) – In adolescents and higher weight children, treatment should be initiated with a dose of 10 mg/day.
Bulimia Nervosa- the recommended dose is 60 mg/day, administered in the morning.
Panic Disorder- Treatment should be initiated with a dose of 10 mg/day. After 1 week, the dose should be increased to 20 mg/day.

IF YOU MISS A DOSE

Take the missed dose as soon as you remember it. If it is almost time for your next dose, skip the dose you missed and take your next dose when you are meant to. Otherwise, take it as soon as you remember, and then go back to taking your doses as you would normally. If you are not sure whether to skip the dose, talk to your doctor or pharmacist. Do not take a double dose to make up for the dose that you missed.

WHAT TO DO IF AN OVERDOSE IS TAKEN

In that case do not delay, ask your doctor immediately what to do or contact your nearest hospital emergency department. Do this even if there are no signs of discomfort or poisoning. Symptoms of overdose may include:

unsteadiness
confusion
unresponsiveness
nervousness
uncontrollable shaking of a part of the body
dizziness
rapid, irregular, or pounding heartbeat
seeing things or hearing voices that do not exist (hallucinating)
fever
fainting
coma (loss of consciousness for a period of time)

Treatment should consist of those general measures employed in the management of overdosage with any drug effective in the treatment of major depressive disorder. Ensure an adequate airway, oxygenation, and ventilation. Monitor cardiac rhythm and vital signs. General supportive and symptomatic measures are also recommended. Induction of emesis is not recommended. Gastric lavage with a large-bore orogastric tube with appropriate airway protection, if needed, may be indicated if performed soon after ingestion, or in symptomatic patients. Activated charcoal should be administered. Due to the large volume of distribution of this drug, forced diuresis, dialysis, hemoperfusion, and exchange transfusion are unlikely to be of benefit. No specific antidotes for fluoxetine are known.

TAKING OTHER MEDICINE

· Please tell your doctor if you are taking or have recently taken any other medicines, including medicines obtained without prescription, your doctor may wish to alter your dose of FLUVEXO if you are taking any drug: ·          Pimozide
·          Monoamine oxidase (MAO) inhibitors such as isocarboxazid, phenelzine
·          anticoagulants (blood thinners) such as warfarin
·          aspirin and other nonsteroidal anti-inflammatory medications
·          aspirin and other nonsteroidal anti-inflammatory medications (NSAIDs) ;
·          diazepam;
·          digoxin; diuretics (water pills),
·          flecainide;
·          insulin or oral medications for diabetes;
·          lithium

SIDE EFFECTS

If you experience any of the following symptoms, call your doctor immediately:

· hives

· fever

· joint pain

· difficulty breathing or swallowing

· seeing things or hearing voices that do not exist (hallucinating)

· seizures

STORING

· Keep all medicines out of the reach of children.

· Store at room temperature(20 to 25°C)

Disclaimer: Strictly meant for information purpose only. The above information should not be used at one’s own discretion nor should substitute your physician’s advice.