mph Bangladesh


Fluoxetine

(floo ox' e teen)

PCaution when used during lactation : Caution when used during pregnancy

LCI  : Contraindicated in lactation

Molecule Info

 
WARNING

Suicidality and Antidepressant Drugs

Antidepressants increased the risk compared to placebo of suicidal thinking and behavior (suicidality) in children, adolescents, and young adults in short-term studies of major depressive disorder (MDD) and other psychiatric disorders. Anyone considering the use of fluoxetine or any other antidepressant in a child, adolescent, or young adult must balance this risk with the clinical need. Short-term studies did not show an increase in the risk of suicidality with antidepressants compared to placebo in adults beyond age 24; there was a reduction in risk with antidepressants compared to placebo in adults aged 65 and older. Depression and certain other psychiatric disorders are themselves associated with increases in the risk of suicide. Patients of all ages who are started on antidepressant therapy should be monitored appropriately and observed closely for clinical worsening, suicidality, or unusual changes in behavior. Families and caregivers should be advised of the need for close observation and communication with the prescriber. Fluoxetine is approved for use in pediatric patients with MDD and obsessive compulsive disorder (OCD).

Indication(s) & Dosage Depression
Adult: 20-40 mg daily. Max: 80 mg daily. 
Child: 8-18 yr: 10-20 mg daily; initiate at 10 mg daily for lower-wt children, may increase to 20 mg/day after 1 wk if necessary. 
Elderly: Initially, 10 mg daily, may increase by 10-20 mg every few wk as tolerated. 
Max Dosage: 
Hepatic impairment: Dose adjustments may be needed. 

Bulimia nervosa
Adult: 60 mg daily.
Hepatic impairment: Dose adjustments may be needed. 

Obsessive compulsive disorder
Adult: Initially, 20 mg daily increased up to 60 mg daily after several wk if unresponsive. Max: 80 mg daily. 
Child: 7-18 yr: Initially, 10 mg daily; may increase to 20 mg daily after 2 wk in adolescents and higher-wt children. Usual range: 10-60 mg daily.
Hepatic impairment: Dose adjustments may be needed. 

Premenstrual dysphoric disorder
Adult: 20 mg daily continuously. Alternatively, 20 mg daily, to be started 14 days before onset of menstruation and continue until 1st day of menses. May repeat with each cycle, if needed. 
Hepatic impairment: Dose adjustments may be needed. 

Panic disorder
Adult: Initial dose: 10 mg daily, may increase to 20 mg daily after a wk. May increase to 60 mg daily after a few wk, if needed. 
Hepatic impairment: Dose adjustments may be needed.
Administration Should be taken with food. Avoid food & beverage containing tyramine or tryptophan, eg alcohol, beer (incl alcohol-free beer), cheese, yoghurt. See lit for complete list.
Overdosage Symptoms include abnormal accommodation, abnormal gait, confusion, unresponsiveness, nervousness, pulmonary dysfunction, vertigo, tremor, increased BP, impotence, movement disorder and hypomania. Treatment is supportive, activated charcoal may be used to remove unabsorbed drug.
Contraindications Severe renal or hepatic failure; hypersensitivity; lactation; concomitant MAOIs or within 2 wk of MAOI withdrawal.
Special Precautions Unstable epilepsy, liver and renal impairment, cardiac disease, diabetes, electroconvulsive therapy, bleeding disorders, closed-angle glaucoma; pregnancy. May impair performace of skilled tasks; withdraw gradually. Close monitoring of clinical worsening and behavioural changes during the 1st few mth of treatment or when there are dose changes.
Adverse Drug Reaction(s) Nervousness, insomnia, anxiety, headache, tremor, drowsiness, dry mouth, nausea, vomiting, sweating, diarrhoea. Seizures, mania, hypomania or mixed manic states reported. Hyponatraemia; elevation of hepatic enzymes.
Potentially Fatal: Rarely, systemic events possibly related to vasculitis have been reported in patients with rash but may be serious involving lungs, kidney and liver.
Drug Interactions May cause transient shift in plasma conc of tightly protein bound drugs e.g. warfarin and digoxin, resulting in adverse effects. T1/2 of diazepam is prolonged. Avoid concurrent use with clopidogrel.
Potentially Fatal: Serious reactions when combined with MAOIs; at least 14 days should elapse after MAOIs withdrawal before starting fluoxetine treatment or at least 5 wk should elapse after fluoxetine treatment before starting MAOIs therapy. Two-fold increase in plasma levels of other antidepressants when combined with fluoxetine. Monitor lithium levels when combined. Please consult detailed drug interactions before prescribing.
Pregnancy Category (US FDA)
Category C: Either studies in animals have revealed adverse effects on the foetus (teratogenic or embryocidal or other) and there are no controlled studies in women or studies in women and animals are not available. Drugs should be given only if the potential benefit justifies the potential risk to the foetus.
Storage Store at 15-30°C.
Pharmacology
Fluoxetine is a potent and highly selective inhibitor of serotonin (5-HT) re-uptake. No affinity for adrenoceptors or histamine, GABA-B, or muscarinic receptors.
Absorption:  admin: Readily absorbed from the GI tract; peak plasma concentrations after 6-8 hr.
Distribution: Widely distributed; enters breast milk. Protein-binding: 95%.
Metabolism: Extensively hepatic by demethylation to norfluoxetine.
Excretion: Urine. Elimination half-life: 1-3 days (fluoxetine), 4-16 days (norfluoxetine).
ATC Classification N06AB03 - fluoxetine; Belongs to the class of selective serotonin reuptake inhibitors. Used in the management of depression.

Brand/Product Info


Total Products : 7       
Brand Name Manufacturer/Marketer Composition Dosage Form Pack Size & Price
MODIPRAN Beximco Pharmaceuticals Ltd Fluoxetine Hydrochloride BP eq. to Fluoxetine 20mg Capsule 100's: 289.00 MRP
NODEP General Pharmaceuticals Ltd Fluoxetine Hydrochloride BP equivalent to Fluoxetine 20mg Capsule 50's: 140.00 MRP
NODEPRESS Kemiko Pharmaceuticals Ltd Fluoxetine Hydrochloride BP equivalent to Fluoxetine 20mg Capsule 50's: 130.00 MRP
OXETIN Decent Pharma Laboratories Ltd. Fluoxetine Hydrochloride BP equivalent to Fluoxetine 20mg Capsule 50's: 144.00 MRP
PRODEP Sun Pharmaceutical (Bangladesh) Ltd. Fluoxetine Hydrochloride BP equivalent to Fluoxetine 20mg Capsule 50's: 150.00 MRP
PROLERT CAP Square Pharmaceuticals Ltd. Fluoxetine HCl 20mg Capsule 5x10's: 150.50 MRP
SEREN Sonear Laboratories Ltd. Fluoxetine Hydrochloride BP equivalent to Fluoxetine 20mg Capsule 50's: 86.10 MRP

Gen. MedInfo

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.

You should know that your mental health may change in unexpected ways when you take fluoxetine or other antidepressants even if you are an adult over 24 years of age. You may become suicidal, especially at the beginning of your treatment and any time that your dose is increased or decreased. You, your family, or your caregiver should call your doctor right away if you experience any of the following symptoms: new or worsening depression; thinking about harming or killing yourself, or planning or trying to do so; extreme worry; agitation; panic attacks; difficulty falling asleep or staying asleep; aggressive behavior; irritability; acting without thinking; severe restlessness; and frenzied abnormal excitement. Be sure that your family or caregiver knows which symptoms may be serious so they can call the doctor if you are unable to seek treatment on your own.

Your healthcare provider will want to see you often while you are taking fluoxetine, especially at the beginning of your treatment. Be sure to keep all appointments for office visits with your doctor.

The doctor will give you the manufacturer's patient information sheet (Medication Guide) when you begin treatment with fluoxetine. Read the information carefully and ask your doctor if you have any questions. You also can obtain the Medication Guide from the FDA website:http://www.fda.gov/Drugs/DrugSafety/InformationbyDrugClass/UCM096273.

No matter your age, before you take an antidepressant, you, your parent, or your caregiver should talk to your doctor about the risks and benefits of treating your condition with an antidepressant or with other treatments. You should also talk about the risks and benefits of not treating your condition. You should know that having depression or another mental illness greatly increases the risk that you will become suicidal. This risk is higher if you or anyone in your family has or has ever had bipolar disorder (mood that changes from depressed to abnormally excited) or mania (frenzied, abnormally excited mood) or has thought about or attempted suicide. Talk to your doctor about your condition, symptoms, and personal and family medical history. You and your doctor will decide what type of treatment is right for you.

 

Why is this medication prescribed?

Fluoxetine is used to treat depression, obsessive-compulsive disorder (bothersome thoughts that won't go away and the need to perform certain actions over and over), some eating disorders, and panic attacks (sudden, unexpected attacks of extreme fear and worry about these attacks). Fluoxetine is used to relieve the symptoms of premenstrual dysphoric disorder, including mood swings, irritability, bloating, and breast tenderness. Fluoxetine is in a class of medications called selective serotonin reuptake inhibitors (SSRIs). It works by increasing the amount of serotonin, a natural substance in the brain that helps maintain mental balance.

How should this medicine be usedd? 

Fluoxetine may come as a capsule, a tablet, a delayed-release (long-acting) capsule, and a solution (liquid) to take by mouth. Fluoxetine may be taken with or without food. Fluoxetine (Sarafem) comes as a capsule to take by mouth. Fluoxetine capsules, tablets, and liquid are usually taken once a day in the morning or twice a day in the morning and at noon. Fluoxetine delayed-released capsules are usually taken once a week. Fluoxetine (Sarafem) is usually taken once a day, either every day of the month or on certain days of the month. Take fluoxetine at around the same time(s) every day. Follow the directions on your prescription label carefully, and ask your doctor to explain any part you do not understand. Take fluoxetine exactly as directed. Do not take more or less of it or take it more often than prescribed by your doctor.

Your doctor may start you on a low dose of fluoxetine and gradually increase your dose.

It may take 4 to 5 weeks or longer before you feel the full benefit of fluoxetine. Continue to take fluoxetine even if you feel well. Do not stop taking fluoxetine without talking to your doctor. If you suddenly stop taking fluoxetine, you may experience withdrawal symptoms such as mood changes, irritability, agitation, dizziness, numbness or tingling in the hands or feet, anxiety, confusion, headache, tiredness, and difficulty falling asleep or staying asleep. Your doctor will probably decrease your dose gradually.

Other uses for this medicine 

Fluoxetine is also sometimes used to treat alcoholism, attention-deficit disorder, borderline personality disorder, sleep disorders, headaches, mental illness, posttraumatic stress disorder, Tourette's syndrome, obesity, sexual problems, and phobias. Talk to your doctor about the possible risks of using this medication for your condition.

This medication may be prescribed for other uses; ask your doctor for more information.

What special precautions should I follow? 

Before taking fluoxetine, 

  • tell your doctor if you are allergic to fluoxetine or any other medications.
  • tell your doctor if you are taking pimozide,thioridazine or monoamine oxidase (MAO) inhibitors such as isocarboxazid, phenelzine, selegiline, and tranylcypromine, or if you have stopped taking a monoamine oxidase inhibitor within the past 2 weeks. Your doctor will probably tell you that you should not take fluoxetine. If you stop taking fluoxetine, you should wait at least 5 weeks before you begin to take thioridazine or a monoamine oxidase inhibitor.
  • tell your doctor what other prescription and nonprescription medications and vitamins you are taking or plan to take. Be sure to mention any of the following: alprazolam; anticoagulants ('blood thinners') such as warfarin; antidepressants  such as amitriptyline, amoxapine, clomipramine, desipramine, doxepin, imipramine, nortriptyline, protriptyline, and trimipramine; aspirin and other nonsteroidal anti-inflammatory drugs  such as ibuprofen  and naproxen; clopidogrel,clopidogrel, diazepam; digoxin; diuretics; linezolid; flecainide; insulin or oral medications for diabetes; lithium; medications for anxiety and Parkinson's disease; methylene blue; medications for mental illness such as clozapine  and haloperidol; medications for migraine headaches such as almotriptan, eletriptan, frovatriptan, naratriptan, rizatriptan, sumatriptan, and zolmitriptan; medications for seizures such as carbamazepine  and phenytoin; sedatives; sibutramine; sleeping pills; tramadol; tranquilizers; and vinblastine . Your doctor may need to change the doses of your medications or monitor you carefully for side effects.
  • tell your doctor what nutritional supplements and herbal products you are taking, especially products that contain St. John's wort or tryptophan.
  • tell your doctor if you are being treated with electroshock therapy (procedure in which small electric shocks are administered to the brain to treat certain mental illnesses), if you have recently had a heart attack and if you have or have ever had diabetes, glaucoma (increased pressure in your eyes that may lead to vision loss), seizures, or liver or heart disease.
  • tell your doctor if you are pregnant, especially if you are in the last few months of your pregnancy, or if you plan to become pregnant or are breast-feeding. If you become pregnant while taking fluoxetine, call your doctor. Fluoxetine may cause problems in newborns following delivery if it is taken during the last months of pregnancy.

talk to your doctor about the risks and benefits of taking fluoxetine on a daily basis if you are 65 years of age or older. Older adults should not usually take fluoxetine on a daily basis because it is not as safe as other medications that can be used to treat the same conditions.

  • you should know that fluoxetine may make you drowsy. Do not drive a car or operate machinery until you know how this medication affects you.
  • remember that alcohol can add to the drowsiness caused by this medication.

What should I do if I forget a dose? 

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

What side effects can this medication cause? 

Fluoxetine may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away: 

  • nervousness

  • nausea

  • dry mouth

  • sore throat

  • drowsiness

  • weakness

  • uncontrollable shaking of a part of the body

  • loss of appetite

  • weight loss

  • changes in sex drive or ability

  • excessive sweating

Some side effects can be serious. If you experience any of the following symptoms or those listed in the IMPORTANT WARNING section, call your doctor immediately:

  • rash

  • hives

  • fever

  • joint pain

  • swelling of the face, throat, tongue, lips, eyes, hands, feet, ankles, or lower legs

  • difficulty breathing or swallowing

  • fever, sweating, confusion, fast or irregular heartbeat, and severe muscle stiffness

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

  • seizures

Fluoxetine may cause other side effects. Call your doctor if you have any unusual problems while taking this medication.

What should I know about storage and disposal of this medication?

Keep this medication in the container it came in, tightly closed, and out of reach of children. Store it at room temperature and away from excess heat and moisture (not in the bathroom). Throw away any medication that is outdated or no longer needed. Talk to your pharmacist about the proper disposal of your medication.

In case of emergency/overdose 

In case of overdose, consult your doctor. If the victim has collapsed or is not breathing, consult local medical emergency services.

Symptoms of overdose may include the following: 

  • 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)

What other information should I know?

Keep all appointments with your doctor and the laboratory. Your doctor will order certain lab tests to check your response to this medicine.

Do not let anyone else use your medication. If you still have symptoms and need further treatment, consult your doctor.

It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.

Ref: MedlinePlus, U.S. Natl. Library of Medicine


This information is provided for reference only and not a replacement for and should only be used in conjunction with full consultation with a registered medical practitioner. It may not contain all the available information you require and cannot substitute professional medical care, nor does it take into account all individual circumstances. Although great effort has been made to ensure content accuracy, mph-bd shall not be held responsible or liable for any claims or damages arising from the use or misuse of the information contained herein, its contents or omissions, or otherwise.

| See FDA approved Prescribing Information from Brand Manufacturer |    Manufacturer's 
     
| Latest mph edition: 09 Dec 2013 |
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*Trademark name & prescribing information are the property of their respective Manufacturers.

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