PROZAC Capsule (2020)

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Dista Products Company

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BOXED WARNING SECTION

WARNING: SUICIDAL THOUGHTS AND BEHAVIORS Antidepressants increased the risk of suicidal thoughts and behavior in children, adolescents, and young adults in short-term studies. These studies did ...

1. Indications and Usage

PROZAC is indicated for the treatment of: Acute and maintenance treatment of Major Depressive Disorder [see Clinical Studies (14.1)]. Acute and maintenance treatment of obsessions and compulsions ...

2. Dosage and Administration

2.1 Major Depressive Disorder Initial Treatment Adult: Initiate PROZAC 20 mg/day orally in the morning. Consider a dose increase after several weeks if insufficient clinical improvement is observed. ...

3. Dosage Forms and Strengths

10 mg Pulvule is an opaque green cap and opaque green body, imprinted with DISTA 3104 on the cap and Prozac 10 mg on the body 20 mg Pulvule is an opaque green cap and opaque yellow body, imprinted with ...

4. Contraindications

When using PROZAC and olanzapine in combination, also refer to the Contraindications section of the package insert for Symbyax. 4.1 Monoamine Oxidase Inhibitors (MAOIs) The use of MAOIs intended ...

5. Warnings and Precautions

When using PROZAC and olanzapine in combination, also refer to the Warnings and Precautions section of the package insert for Symbyax. 5.1 Suicidal Thoughts and Behaviors in Children, Adolescents, ...

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 ...

6.1. Clinical Trials Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another ...

6.2. Postmarketing Experience

The following adverse reactions have been identified during post approval use of PROZAC. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible ...

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. 7.1 Monoamine Oxidase Inhibitors ...

8. Use in Specific Populations

When using PROZAC and olanzapine in combination, also refer to the Use in Specific Populations section of the package insert for Symbyax.

8.1. Pregnancy

Pregnancy Exposure Registry There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to antidepressants during pregnancy. Healthcare providers are encouraged to register ...

8.2. Lactation

Risk Summary Data from published literature report the presence of fluoxetine and norfluoxetine in human milk (see Data). There are reports of agitation, irritability, poor feeding, and poor weight ...

8.4. Pediatric Use

Use of PROZAC in children The efficacy of PROZAC for the treatment of Major Depressive Disorder was demonstrated in two 8- to 9-week placebo-controlled clinical trials with 315 pediatric outpatients ages ...

8.5. Geriatric Use

US fluoxetine clinical trials included 687 patients ≥65 years of age and 93 patients ≥75 years of age. The efficacy in geriatric patients has been established [see Clinical Studies (14.1)]. For ...

8.6. Hepatic Impairment

In subjects with cirrhosis of the liver, the clearances of fluoxetine and its active metabolite, norfluoxetine, were decreased, thus increasing the elimination half-lives of these substances. A lower or ...

9.3. Dependence

PROZAC has not been systematically studied, in animals or humans, for its potential for abuse, tolerance, or physical dependence. While the premarketing clinical experience with PROZAC did not reveal any ...

10. Overdosage

10.1 Human Experience Worldwide exposure to fluoxetine hydrochloride is estimated to be over 38 million patients (circa 1999). Of the 1578 cases of overdose involving fluoxetine hydrochloride, alone or ...

11. Description

PROZAC (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). ...

12.1. Mechanism of Action

Although the exact mechanism of PROZAC is unknown, it is presumed to be linked to its inhibition of CNS neuronal uptake of serotonin.

12.2. Pharmacodynamics

Studies at clinically relevant doses in man have demonstrated that fluoxetine blocks the uptake of serotonin into human platelets. Studies in animals also suggest that fluoxetine is a much more potent ...

12.3. Pharmacokinetics

Systemic Bioavailability In man, following a single oral 40 mg dose, peak plasma concentrations of fluoxetine from 15 to 55 ng/mL are observed after 6 to 8 hours. Food does not appear to affect the systemic ...

13.1. Carcinogenesis, Mutagenesis, Impairment of Fertility

Carcinogenicity The dietary administration of fluoxetine to rats and mice for 2 years at doses of up to 10 and 12 mg/kg/day, respectively [approximately 2.4 and 1.44 times, respectively, the maximum recommended ...

13.2. Animal Toxicology and/or Pharmacology

Phospholipids are increased in some tissues of mice, rats, and dogs given fluoxetine chronically. This effect is reversible after cessation of fluoxetine treatment. Phospholipid accumulation in animals ...

14. Clinical Studies

Efficacy for PROZAC was established for the: Acute and maintenance treatment of Major Depressive Disorder in adults, and children and adolescents (8 to 18 years) in 7 short-term and 2 long-term, placebo-controlled ...

16.1. How Supplied

The following products are manufactured by Eli Lilly and Company for Dista Products Company: Pulvule are available in 10 mg, 20 mg and 40 mg capsule strengths and packages as follows:   Pulvule ...

16.2. Storage and Handling

Store at Controlled Room Temperature, 15° to 30°C (59° to 86°F).

17. Patient Counseling Information

Advise the patient to read the FDA-approved patient labeling (Medication Guide). Patients should be advised of the following issues and asked to alert their prescriber if these occur while taking PROZAC ...