PRISTIQ Extended-release tablet (2020)

Βιβλιογραφική αναφορά

Συγγραφείς

PD-Rx Pharmaceuticals, Inc.

Λέξεις κλειδιά

43063-262

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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

PRISTIQ is indicated for the treatment of adults with major depressive disorder (MDD) [see Clinical Studies (14)].

2. Dosage and Administration

2.1 General Instructions for Use The recommended dose for PRISTIQ is 50 mg once daily, with or without food. The 50 mg dose is both a starting dose and the therapeutic dose. PRISTIQ should be taken at ...

3. Dosage Forms and Strengths

25 mg Tablet: tan, square pyramid tablet debossed with W over 25 on the flat side. 50 mg Tablet: light pink, square pyramid tablet debossed with W over 50 on the flat side. 100 mg Tablet: ...

4. Contraindications

Hypersensitivity to desvenlafaxine succinate, venlafaxine hydrochloride or to any excipients in the PRISTIQ formulation. Angioedema has been reported in patients treated with PRISTIQ [see Adverse Reactions ...

5. Warnings and Precautions

5.1 Suicidal Thoughts and Behaviors in Pediatric and Young Adult Patients Patients with MDD, both adult and pediatric, may experience worsening of their depression and/or the emergence of suicidal ideation ...

6. Adverse Reactions

The following adverse reactions are discussed in greater detail in other sections of the label. Hypersensitivity [see Contraindications (4)] Suicidal Thoughts and Behaviors in Pediatric and Young ...

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 studies of another ...

6.2. Postmarketing Experience

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

7. Drug Interactions

7.1 Drugs Having Clinically Important Interactions with PRISTIQ Table 8. Clinically Important Drug Interactions with PRISTIQ: Monoamine Oxidase Inhibitors (MAOI) Clinical Impact The ...

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 Available limited data from published literature show low levels of desvenlafaxine in human milk, and have not shown adverse reactions in breastfed infants (see Data). There are no ...

8.4. Pediatric Use

The safety and effectiveness of PRISTIQ have not been established in pediatric patients for the treatment of MDD. Efficacy was not demonstrated in two adequate and well controlled, 8-week, randomized, ...

8.5. Geriatric Use

Of the 4,158 patients in pre-marketing clinical studies with PRISTIQ, 6% were 65 years of age or older. No overall differences in safety or efficacy were observed between these patients and younger patients; ...

8.6. Renal Impairment

Adjust the maximum recommended dosage in patients with moderate or severe renal impairment (CLcr 15 to 50 mL/min, C-G), or end-stage renal disease (CLcr <15 mL/min, C-G) [see Dosage and Administration ...

8.7. Hepatic Impairment

Adjust the maximum recommended dosage in patients with moderate to severe hepatic impairment (Child-Pugh score 7 to 15) [see Dosage and Administration (2.3) and Clinical Pharmacology (12.3)]. ...

9.1. Controlled Substance

PRISTIQ is not a controlled substance.

10. Overdosage

10.1 Human Experience with Overdosage There is limited clinical trial experience with desvenlafaxine succinate overdosage in humans. However, desvenlafaxine (PRISTIQ) is the major active metabolite of ...

11. Description

PRISTIQ is an extended-release tablet for oral administration that contains desvenlafaxine succinate, a structurally novel SNRI for the treatment of MDD. Desvenlafaxine (O-desmethylvenlafaxine) is the ...

12.1. Mechanism of Action

The exact mechanism of the antidepressant action of desvenlafaxine is unknown, but is thought to be related to the potentiation of serotonin and norepinephrine in the central nervous system, through inhibition ...

12.2. Pharmacodynamics

Desvenlafaxine lacked significant affinity for numerous receptors, including muscarinic-cholinergic, H1-histaminergic, or α 1-adrenergic receptors in vitro. Desvenlafaxine ...

12.3. Pharmacokinetics

The single-dose pharmacokinetics of desvenlafaxine are linear and dose-proportional in a dose range of 50 to 600 mg (1 to 12 times the recommended approved dosage) per day. With once-daily dosing, steady-state ...

13.1. Carcinogenesis, Mutagenesis, Impairment of Fertility

Carcinogenesis Desvenlafaxine succinate administered by oral gavage to mice and rats for 2 years did not increase the incidence of tumors in either study. Mice received desvenlafaxine succinate at dosages ...

14. Clinical Studies

Major Depressive Disorder The efficacy of PRISTIQ as a treatment for depression was established in four 8-week, randomized, double-blind, placebo-controlled, fixed-dose studies (at doses of 50 mg per day ...

16.1. How Supplied

PRISTIQ (desvenlafaxine) extended-release tablets are available as follows: 50 mg, light pink, square pyramid tablet debossed with W (over) 50 on the flat side NDC 43063-262-30, bottle of 30 tablets. ...

16.2. Storage and Handling

Store at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature]. Each tablet contains 76 mg of desvenlafaxine succinate equivalent to ...

17. Patient Counseling Information

Advise the patient to read the FDA-approved patient labeling (Medication Guide). Suicidal Thoughts and Behaviors Advise patients and caregivers to look for the emergence of suicidality, especially early ...