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fluoxetine hydrochloride
Overview
What is fluoxetine?
Fluoxetine capsules USP is a selective serotonin reuptake inhibitor for oral administration. It is also marketed for the treatment of premenstrual dysphoric disorder (Sarafem, fluoxetine hydrochloride). It is designated (±)-N-methyl-3-phenyl-3-[(α,α,α-trifluoro--tolyl)oxy]propylamine hydrochloride and has the following structural formula:
CHFNO•HCl M.W. 345.79
Fluoxetine hydrochloride is a white to off-white crystalline solid with a solubility of 14 mg/mL in water.
Each fluoxetine capsule, for oral administration, contains fluoxetine hydrochloride USP equivalent to 20 mg of fluoxetine and has the following inactive ingredients: black iron oxide, colloidal silicon dioxide, corn starch, D&C yellow #10 aluminum lake, FD&C blue #1, FD&C blue #1 aluminum lake, FD&C blue #2 aluminum lake, FD&C red #40 aluminum lake, gelatin, magnesium stearate, pregelatinized starch, sodium lauryl sulfate, titanium dioxide.
What does fluoxetine look like?
What are the available doses of fluoxetine?
• Capsules: 20 mg (3)
What should I talk to my health care provider before I take fluoxetine?
When using fluoxetine and olanzapine in combination, also refer to the Use in Specific Populations section of the package insert for olanzapine and fluoxetine hydrochloride capsules
How should I use fluoxetine?
Fluoxetine is indicated for the acute and maintenance treatment of Major Depressive Disorder in adult patients and in pediatric patients aged 8 to18 years
The usefulness of the drug in adult and pediatric patients receiving fluoxetine for extended periods, should periodically be re-evaluated
Initial Treatment
Adult
A dose increase may be considered after several weeks if insufficient clinical improvement is observed. Doses above 20 mg/day may be administered on a once-a-day (morning) or BID schedule (i.e., morning and noon) and should not exceed a maximum dose of 80 mg/day.
Pediatric (children and adolescents)
[see Clinical Studies ()].
However, due to higher plasma levels in lower weight children, the starting and target dose in this group may be 10 mg/day. A dose increase to 20 mg/day may be considered after several weeks if insufficient clinical improvement is observed.
All patients
Maintenance/Continuation/Extended Treatment
Daily Dosing
[see Clinical Studies ()].
Switching Patients to a Tricyclic Antidepressant (TCA)
[see Drug Interactions ()].
Switching Patients to or From a Monoamine Oxidase Inhibitor (MAOI)
[see Contraindications () and Drug Interactions ()].
What interacts with fluoxetine?
Sorry No Records found
What are the warnings of fluoxetine?
Sorry No Records found
What are the precautions of fluoxetine?
Sorry No Records found
What are the side effects of fluoxetine?
Sorry No records found
What should I look out for while using fluoxetine?
When using fluoxetine and olanzapine in combination, also refer to the Contraindications section of the package insert for olanzapine and fluoxetine hydrochloride capsules.
The use of fluoxetine is contraindicated with the following:
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 capsules
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) .
When using fluoxetine and olanzapine in combination, also refer to Boxed Warning section of the package insert for olanzapine and fluoxetine hydrochloride capsules.
What might happen if I take too much fluoxetine?
How should I store and handle fluoxetine?
Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature].Protect from light.Dispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure (as required).Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature].Protect from light.Dispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure (as required).Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature].Protect from light.Dispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure (as required).Cimetidine Tablets USP 300 mg are available as white to off-white, round, unscored, film-coated tablets, debossed "300" on one side and "7117" on the other side, packaged in bottles of 100, 500 and 1000 tablets.Cimetidine Tablets USP 400 mg are available as white to off-white, capsule-shaped, scored, film-coated tablets, debossed "400" on one side and "7171" on the other side, packaged in bottles of 60, 100 and 500 tablets.Cimetidine Tablets USP 800 mg are available as white to off-white, oval-shaped, scored, film-coated tablets, debossed "800" on one side and "7711" on the other side, packaged in bottles of 30, 100 and 500 tablets.PHARMACIST: Dispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure (as required).Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature].*Theo-Dur is a registered trademark of Key Pharmaceuticals, Inc.Iss. 3/2009Manufactured in Ireland By:IVAX PHARMACEUTICALS IRELANDWaterford, IrelandManufactured For:TEVA PHARMACEUTICALS USASellersville, PA 18960Cimetidine Tablets USP 300 mg are available as white to off-white, round, unscored, film-coated tablets, debossed "300" on one side and "7117" on the other side, packaged in bottles of 100, 500 and 1000 tablets.Cimetidine Tablets USP 400 mg are available as white to off-white, capsule-shaped, scored, film-coated tablets, debossed "400" on one side and "7171" on the other side, packaged in bottles of 60, 100 and 500 tablets.Cimetidine Tablets USP 800 mg are available as white to off-white, oval-shaped, scored, film-coated tablets, debossed "800" on one side and "7711" on the other side, packaged in bottles of 30, 100 and 500 tablets.PHARMACIST: Dispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure (as required).Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature].*Theo-Dur is a registered trademark of Key Pharmaceuticals, Inc.Iss. 3/2009Manufactured in Ireland By:IVAX PHARMACEUTICALS IRELANDWaterford, IrelandManufactured For:TEVA PHARMACEUTICALS USASellersville, PA 18960Cimetidine Tablets USP 300 mg are available as white to off-white, round, unscored, film-coated tablets, debossed "300" on one side and "7117" on the other side, packaged in bottles of 100, 500 and 1000 tablets.Cimetidine Tablets USP 400 mg are available as white to off-white, capsule-shaped, scored, film-coated tablets, debossed "400" on one side and "7171" on the other side, packaged in bottles of 60, 100 and 500 tablets.Cimetidine Tablets USP 800 mg are available as white to off-white, oval-shaped, scored, film-coated tablets, debossed "800" on one side and "7711" on the other side, packaged in bottles of 30, 100 and 500 tablets.PHARMACIST: Dispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure (as required).Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature].*Theo-Dur is a registered trademark of Key Pharmaceuticals, Inc.Iss. 3/2009Manufactured in Ireland By:IVAX PHARMACEUTICALS IRELANDWaterford, IrelandManufactured For:TEVA PHARMACEUTICALS USASellersville, PA 18960Cimetidine Tablets USP 300 mg are available as white to off-white, round, unscored, film-coated tablets, debossed "300" on one side and "7117" on the other side, packaged in bottles of 100, 500 and 1000 tablets.Cimetidine Tablets USP 400 mg are available as white to off-white, capsule-shaped, scored, film-coated tablets, debossed "400" on one side and "7171" on the other side, packaged in bottles of 60, 100 and 500 tablets.Cimetidine Tablets USP 800 mg are available as white to off-white, oval-shaped, scored, film-coated tablets, debossed "800" on one side and "7711" on the other side, packaged in bottles of 30, 100 and 500 tablets.PHARMACIST: Dispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure (as required).Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature].*Theo-Dur is a registered trademark of Key Pharmaceuticals, Inc.Iss. 3/2009Manufactured in Ireland By:IVAX PHARMACEUTICALS IRELANDWaterford, IrelandManufactured For:TEVA PHARMACEUTICALS USASellersville, PA 18960Cimetidine Tablets USP 300 mg are available as white to off-white, round, unscored, film-coated tablets, debossed "300" on one side and "7117" on the other side, packaged in bottles of 100, 500 and 1000 tablets.Cimetidine Tablets USP 400 mg are available as white to off-white, capsule-shaped, scored, film-coated tablets, debossed "400" on one side and "7171" on the other side, packaged in bottles of 60, 100 and 500 tablets.Cimetidine Tablets USP 800 mg are available as white to off-white, oval-shaped, scored, film-coated tablets, debossed "800" on one side and "7711" on the other side, packaged in bottles of 30, 100 and 500 tablets.PHARMACIST: Dispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure (as required).Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature].*Theo-Dur is a registered trademark of Key Pharmaceuticals, Inc.Iss. 3/2009Manufactured in Ireland By:IVAX PHARMACEUTICALS IRELANDWaterford, IrelandManufactured For:TEVA PHARMACEUTICALS USASellersville, PA 18960Cimetidine Tablets USP 300 mg are available as white to off-white, round, unscored, film-coated tablets, debossed "300" on one side and "7117" on the other side, packaged in bottles of 100, 500 and 1000 tablets.Cimetidine Tablets USP 400 mg are available as white to off-white, capsule-shaped, scored, film-coated tablets, debossed "400" on one side and "7171" on the other side, packaged in bottles of 60, 100 and 500 tablets.Cimetidine Tablets USP 800 mg are available as white to off-white, oval-shaped, scored, film-coated tablets, debossed "800" on one side and "7711" on the other side, packaged in bottles of 30, 100 and 500 tablets.PHARMACIST: Dispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure (as required).Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature].*Theo-Dur is a registered trademark of Key Pharmaceuticals, Inc.Iss. 3/2009Manufactured in Ireland By:IVAX PHARMACEUTICALS IRELANDWaterford, IrelandManufactured For:TEVA PHARMACEUTICALS USASellersville, PA 18960Cimetidine Tablets USP 300 mg are available as white to off-white, round, unscored, film-coated tablets, debossed "300" on one side and "7117" on the other side, packaged in bottles of 100, 500 and 1000 tablets.Cimetidine Tablets USP 400 mg are available as white to off-white, capsule-shaped, scored, film-coated tablets, debossed "400" on one side and "7171" on the other side, packaged in bottles of 60, 100 and 500 tablets.Cimetidine Tablets USP 800 mg are available as white to off-white, oval-shaped, scored, film-coated tablets, debossed "800" on one side and "7711" on the other side, packaged in bottles of 30, 100 and 500 tablets.PHARMACIST: Dispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure (as required).Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature].*Theo-Dur is a registered trademark of Key Pharmaceuticals, Inc.Iss. 3/2009Manufactured in Ireland By:IVAX PHARMACEUTICALS IRELANDWaterford, IrelandManufactured For:TEVA PHARMACEUTICALS USASellersville, PA 18960Cimetidine Tablets USP 300 mg are available as white to off-white, round, unscored, film-coated tablets, debossed "300" on one side and "7117" on the other side, packaged in bottles of 100, 500 and 1000 tablets.Cimetidine Tablets USP 400 mg are available as white to off-white, capsule-shaped, scored, film-coated tablets, debossed "400" on one side and "7171" on the other side, packaged in bottles of 60, 100 and 500 tablets.Cimetidine Tablets USP 800 mg are available as white to off-white, oval-shaped, scored, film-coated tablets, debossed "800" on one side and "7711" on the other side, packaged in bottles of 30, 100 and 500 tablets.PHARMACIST: Dispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure (as required).Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature].*Theo-Dur is a registered trademark of Key Pharmaceuticals, Inc.Iss. 3/2009Manufactured in Ireland By:IVAX PHARMACEUTICALS IRELANDWaterford, IrelandManufactured For:TEVA PHARMACEUTICALS USASellersville, PA 18960Cimetidine Tablets USP 300 mg are available as white to off-white, round, unscored, film-coated tablets, debossed "300" on one side and "7117" on the other side, packaged in bottles of 100, 500 and 1000 tablets.Cimetidine Tablets USP 400 mg are available as white to off-white, capsule-shaped, scored, film-coated tablets, debossed "400" on one side and "7171" on the other side, packaged in bottles of 60, 100 and 500 tablets.Cimetidine Tablets USP 800 mg are available as white to off-white, oval-shaped, scored, film-coated tablets, debossed "800" on one side and "7711" on the other side, packaged in bottles of 30, 100 and 500 tablets.PHARMACIST: Dispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure (as required).Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature].*Theo-Dur is a registered trademark of Key Pharmaceuticals, Inc.Iss. 3/2009Manufactured in Ireland By:IVAX PHARMACEUTICALS IRELANDWaterford, IrelandManufactured For:TEVA PHARMACEUTICALS USASellersville, PA 18960Cimetidine Tablets USP 300 mg are available as white to off-white, round, unscored, film-coated tablets, debossed "300" on one side and "7117" on the other side, packaged in bottles of 100, 500 and 1000 tablets.Cimetidine Tablets USP 400 mg are available as white to off-white, capsule-shaped, scored, film-coated tablets, debossed "400" on one side and "7171" on the other side, packaged in bottles of 60, 100 and 500 tablets.Cimetidine Tablets USP 800 mg are available as white to off-white, oval-shaped, scored, film-coated tablets, debossed "800" on one side and "7711" on the other side, packaged in bottles of 30, 100 and 500 tablets.PHARMACIST: Dispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure (as required).Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature].*Theo-Dur is a registered trademark of Key Pharmaceuticals, Inc.Iss. 3/2009Manufactured in Ireland By:IVAX PHARMACEUTICALS IRELANDWaterford, IrelandManufactured For:TEVA PHARMACEUTICALS USASellersville, PA 18960Cimetidine Tablets USP 300 mg are available as white to off-white, round, unscored, film-coated tablets, debossed "300" on one side and "7117" on the other side, packaged in bottles of 100, 500 and 1000 tablets.Cimetidine Tablets USP 400 mg are available as white to off-white, capsule-shaped, scored, film-coated tablets, debossed "400" on one side and "7171" on the other side, packaged in bottles of 60, 100 and 500 tablets.Cimetidine Tablets USP 800 mg are available as white to off-white, oval-shaped, scored, film-coated tablets, debossed "800" on one side and "7711" on the other side, packaged in bottles of 30, 100 and 500 tablets.PHARMACIST: Dispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure (as required).Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature].*Theo-Dur is a registered trademark of Key Pharmaceuticals, Inc.Iss. 3/2009Manufactured in Ireland By:IVAX PHARMACEUTICALS IRELANDWaterford, IrelandManufactured For:TEVA PHARMACEUTICALS USASellersville, PA 18960Cimetidine Tablets USP 300 mg are available as white to off-white, round, unscored, film-coated tablets, debossed "300" on one side and "7117" on the other side, packaged in bottles of 100, 500 and 1000 tablets.Cimetidine Tablets USP 400 mg are available as white to off-white, capsule-shaped, scored, film-coated tablets, debossed "400" on one side and "7171" on the other side, packaged in bottles of 60, 100 and 500 tablets.Cimetidine Tablets USP 800 mg are available as white to off-white, oval-shaped, scored, film-coated tablets, debossed "800" on one side and "7711" on the other side, packaged in bottles of 30, 100 and 500 tablets.PHARMACIST: Dispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure (as required).Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature].*Theo-Dur is a registered trademark of Key Pharmaceuticals, Inc.Iss. 3/2009Manufactured in Ireland By:IVAX PHARMACEUTICALS IRELANDWaterford, IrelandManufactured For:TEVA PHARMACEUTICALS USASellersville, PA 18960Cimetidine Tablets USP 300 mg are available as white to off-white, round, unscored, film-coated tablets, debossed "300" on one side and "7117" on the other side, packaged in bottles of 100, 500 and 1000 tablets.Cimetidine Tablets USP 400 mg are available as white to off-white, capsule-shaped, scored, film-coated tablets, debossed "400" on one side and "7171" on the other side, packaged in bottles of 60, 100 and 500 tablets.Cimetidine Tablets USP 800 mg are available as white to off-white, oval-shaped, scored, film-coated tablets, debossed "800" on one side and "7711" on the other side, packaged in bottles of 30, 100 and 500 tablets.PHARMACIST: Dispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure (as required).Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature].*Theo-Dur is a registered trademark of Key Pharmaceuticals, Inc.Iss. 3/2009Manufactured in Ireland By:IVAX PHARMACEUTICALS IRELANDWaterford, IrelandManufactured For:TEVA PHARMACEUTICALS USASellersville, PA 18960
Clinical Information
Chemical Structure
No Image foundClinical Pharmacology
Although the exact mechanism of fluoxetine is unknown, it is presumed to be linked to its inhibition of CNS neuronal uptake of serotonin.
Non-Clinical Toxicology
When using fluoxetine and olanzapine in combination, also refer to the Contraindications section of the package insert for olanzapine and fluoxetine hydrochloride capsules.The use of fluoxetine is contraindicated with the following:
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 capsules
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) .
When using fluoxetine and olanzapine in combination, also refer to Boxed Warning section of the package insert for olanzapine and fluoxetine hydrochloride capsules.
Cimetidine, apparently through an effect on certain microsomal enzyme systems, has been reported to reduce the hepatic metabolism of warfarin-type anticoagulants, phenytoin, propranolol, nifedipine, chlordiazepoxide, diazepam, certain tricyclic antidepressants, lidocaine, theophylline and metronidazole, thereby delaying elimination and increasing blood levels of these drugs.
Clinically significant effects have been reported with the warfarin anticoagulants; therefore, close monitoring of prothrombin time is recommended, and adjustment of the anticoagulant dose may be necessary when cimetidine is administered concomitantly. Interaction with phenytoin, lidocaine and theophylline has also been reported to produce adverse clinical effects.
However, a crossover study in healthy subjects receiving either 300 mg four times daily or 800 mg at bedtime of cimetidine concomitantly with a 300 mg twice daily dosage of theophylline (Theo-Dur®) demonstrated less alteration in steady-state theophylline peak serum levels with the 800 mg at bedtime regimen, particularly in subjects aged 54 years and older. Data beyond ten days are not available. (Note: All patients receiving theophylline should be monitored appropriately, regardless of concomitant drug therapy.)
Dosage of the drugs mentioned above and other similarly metabolized drugs, particularly those of low therapeutic ratio or in patients with renal and/or hepatic impairment, may require adjustment when starting or stopping the concomitant administration of cimetidine to maintain optimum therapeutic blood levels.
Alteration of pH may affect the absorption of certain drugs (e.g., ketoconazole). If these products are needed, they should be given at least 2 hours before cimetidine administration.
Additional clinical experience may reveal other drugs affected by the concomitant administration of cimetidine.
When using fluoxetine and olanzapine in combination, also refer to the Warnings and Precautions section of the package insert for olanzapine and fluoxetine hydrochloride capsules.
When using fluoxetine and olanzapine in combination, also refer to the Adverse Reactions section of the package insert for olanzapine and fluoxetine hydrochloride capsules.
Reference
This information is obtained from the National Institute of Health's Standard Packaging Label drug database.
"https://dailymed.nlm.nih.gov/dailymed/"
While we update our database periodically, we cannot guarantee it is always updated to the latest version.
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Clonazepam Description Each single-scored tablet, for oral administration, contains 0.5 mg, 1 mg, or 2 mg Clonazepam, USP, a benzodiazepine. Each tablet also contains corn starch, lactose monohydrate, magnesium stearate, microcrystalline cellulose, and povidone. Clonazepam tablets USP 0.5 mg contain Yellow D&C No. 10 Aluminum Lake. Clonazepam tablets USP 1 mg contain Yellow D&C No. 10 Aluminum Lake, as well as FD&C Blue No. 1 Aluminum Lake. Chemically, Clonazepam, USP is 5-(o-chlorophenyl)-1,3-dihydro-7-nitro-2H-1,4-benzodiazepin-2-one. It is a light yellow crystalline powder. It has the following structural formula: C15H10ClN3O3 M.W. 315.72Tips
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Interactions
Interactions
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