fluoxetine hydrochloride 10 mg/1
fluoxetine hydrochloride · TABLET, COATED · Endo USA, Inc.
fluoxetine hydrochloride is a tablet, coated containing fluoxetine hydrochloride at 10 mg/1, taken oral. Manufactured by Endo USA, Inc..
Key Facts
- Brand Name
- fluoxetine hydrochloride
- Generic Name
- fluoxetine hydrochloride
- NDC Code (Product)
49884-335- Manufacturer
- Endo USA, Inc.
- Strength
- 10 mg/1
- Dosage Form
- TABLET, COATED
- Route
- ORAL
- Marketing Status
- Application #
- ANDA203836
- Marketing Start
- 08/22/2016
Recall History
Attix Pharmaceuticals
Penicillin Cross Contamination: All lots of all products repackaged and distributed between 01/05/12 and 02/12/15 are being recalled because they were repackaged in a facility with penicillin products without adequate separation which could introduce the potential for cross contamination with penicillin.
Side Effects Reported to FDA
FDA FAERS database · These are reported events, not confirmed side effects
Full Prescribing Information
Indications & Usage
1 INDICATIONS AND USAGE Fluoxetine tablets are indicated for the treatment of: Major Depressive Disorder (MDD). The efficacy of fluoxetine in MDD was established in one 5 week trial, three 6 week trials, and one maintenance study in adults. The efficacy of fluoxetine was also established in two 8 to 9 week trials in pediatric patients 8 to 18 years of age [see Clinical Studies (14.1) ]. Obsessions and compulsions in patients with Obsessive Compulsive Disorder (OCD). The efficacy of fluoxetine in OCD was demonstrated in two 13 week trials in adults and one 13 week trial in pediatric patients 7 to 17 years of age [see Clinical Studies (14.2) ]. Binge-eating and vomiting behaviors in patients with moderate to severe Bulimia Nervosa. The efficacy of fluoxetine in Bulimia Nervosa was demonstrated in two 8 week trials and one 16 week trial in adults [see Clinical Studies (14.3) ]. Panic Disorder, with or without agoraphobia. The efficacy of fluoxetine in Panic Disorder was demonstrated in two 12 week trials in adults [see Clinical Studies ( 14.4 )]. Fluoxetine tablets are a selective serotonin reuptake inhibitor (SSRI) indicated for the treatment of: Major Depressive Disorder (MDD) ( 1 )…
Dosage & Administration
2 DOSAGE AND ADMINISTRATION This product is only available in a 60 mg dosage form. A 30 mg dose may be achieved with one-half of the scored tablet. Use of this product requires initial titration with another fluoxetine product according to the dosing guidelines indicated below. Use another fluoxetine product for initial doses of 10 to 20 mg/day or for doses other than 30 mg or 60 mg: Indication Adult Pediatric MDD (2.1) 20 mg/day in morning (initial dose) 20 mg/day (target dose) 80 mg/day (maximum dose studied) 10 to 20 mg/day (initial dose)* *This product has not been studied in doses greater than 20 mg/day in pediatric MDD. OCD (2.2) 20 mg/day in morning (initial dose) 20 to 60 mg/day (target dose) 10 mg/day (initial dose) 10 to 60 mg/day (target dose) Bulimia Nervosa (2.3) 60 mg/day in morning -- Panic Disorder (2.4) 10 mg/day (initial dose) 20 mg/day (target dose) 60 mg/day (maximum dose studied) -- No additional benefits seen at higher doses above 20 mg/day in MDD ( 2.1 , 14.1 ) Use a lower or less frequent dosage in patients with hepatic impairment, the elderly, and for patients with concurrent disease or on multiple concomitant medications ( 2.5 , 8.6 ) 2.1 Major Depressive …
Contraindications
4 CONTRAINDICATIONS Monoamine Oxidase Inhibitors (MAOIs) : Do not use MAOIs intended to treat psychiatric disorders with fluoxetine or within 5 weeks of stopping treatment with fluoxetine. Do not use fluoxetine within 14 days of stopping an MAOI intended to treat psychiatric disorders. In addition, do not start fluoxetine in a patient who is being treated with linezolid or intravenous methylene blue ( 4.1 , 7.1 ) Pimozide ( 4.2 , 5.11 , 7.6 , 7.7 ) Thioridazine: Do not use concomitantly with or within 5 weeks of discontinuing fluoxetine ( 4.2 , 5.11 , 7.6 , 7.7 ) Known hypersensitivity to fluoxetine products ( 4.2 , 5.3 ) 4.1 Monoamine Oxidase Inhibitors (MAOIs) The use of MAOIs intended to treat psychiatric disorders with fluoxetine or within 5 weeks of stopping treatment with fluoxetine is contraindicated because of an increased risk of serotonin syndrome. The use of fluoxetine within 14 days of stopping an MAOI intended to treat psychiatric disorders is also contraindicated [see Dosage and Administration ( 2.6 ) and Warnings and Precautions (5.2) ]. Starting fluoxetine in a patient who is being treated with MAOIs such as linezolid or intravenous methylene blue is also contraindi…
Drug Interactions
7 DRUG INTERACTIONS As with all drugs, the potential for interaction by a variety of mechanisms (e.g., pharmacodynamic, pharmacokinetic drug inhibition or enhancement, etc) is a possibility. Drugs Metabolized by CYP2D6: Fluoxetine is a potent inhibitor of CYP2D6 enzyme pathway ( 7.6 ) Tricyclic Antidepressants (TCAs): Monitor TCA levels during co-administration with fluoxetine or when fluoxetine has been recently discontinued ( 5.2 , 7.6 ) Benzodiazepines: Diazepam—increased t1/2, alprazolam—further psychomotor performance decrement due to increased levels ( 7.6 ) Antipsychotics: Potential for elevation of haloperidol and clozapine levels (7.6 ) Anticonvulsants: Potential for elevated phenytoin and carbamazepine levels and clinical anticonvulsant toxicity (7.6) Serotonergic Drugs: ( 2.6 , 2.7 , 4.1 , 5.2 ) Drugs that Prolong the QT Interval: Do not use fluoxetine with thioridazine or pimozide. Use with caution in combination with other drugs that prolong the QT interval ( 4.2 , 5.11 , 7.6 , 7.7 ) 7.1 Monoamine Oxidase Inhibitors (MAOIs) [See Dosage and Administration ( 2.6, 2.7 ), Contraindications ( 4.1 ), and Warnings and Precautions ( 5.2 )]. 7.2 CNS Acting Drugs Caution is advi…
Adverse Reactions
6 ADVERSE REACTIONS The following adverse reactions are discussed in more detail in other sections of the labeling: • Suicidal Thoughts and Behaviors in Children, Adolescents, and Young Adults [see Boxed Warning and Warnings and Precautions ( 5.1 )] • Serotonin Syndrome [see Warnings and Precautions ( 5.2 )] • Allergic Reactions and Rash [see Warnings and Precautions ( 5.3 )] • Screening Patients for Bipolar Disorder and Monitoring for Mania/Hypomania [see Warnings and Precautions ( 5.4 )] • Seizures [see Warnings and Precautions ( 5.5 )] • Altered Appetite and Weight [see Warnings and Precautions ( 5.6 )] • Increased Risk of Bleeding [see Warnings and Precautions ( 5.7 )] • Angle-closure Glaucoma [see Warnings and Precautions ( 5.8 )] • Hyponatremia [see Warnings and Precautions ( 5.9 )] • Anxiety and Insomnia [see Warnings and Precautions ( 5.10 )] • QT Prolongation [see Warnings and Precautions ( 5.11 )] • Potential for Cognitive and Motor Impairment [see Warnings and Precautions ( 5.13 )] • Discontinuation Adverse Reactions [see Warnings and Precautions (5.15 )] Most common adverse reactions (≥ 5% and at least twice that for placebo): abnormal dreams, abnormal ejaculation, anor…
Frequently Asked Questions
What is fluoxetine hydrochloride used for?
fluoxetine hydrochloride contains fluoxetine hydrochloride. It is a tablet, coated taken oral. Consult your doctor for specific uses.
Is fluoxetine hydrochloride a controlled substance?
fluoxetine hydrochloride is not classified as a controlled substance by the DEA.
What is the generic name for fluoxetine hydrochloride?
The generic name for fluoxetine hydrochloride is fluoxetine hydrochloride. There are 11 other brand versions of fluoxetine hydrochloride.
What is the NDC code for fluoxetine hydrochloride 10 mg/1?
The NDC (National Drug Code) for fluoxetine hydrochloride 10 mg/1 is 49884-335, listed by Endo USA, Inc..