PAXIL CR 12.5 mg/1
paroxetine hydrochloride · TABLET, FILM COATED, EXTENDED RELEASE · Apotex Corp
PAXIL CR is a tablet, film coated, extended release containing paroxetine hydrochloride at 12.5 mg/1, taken oral. Manufactured by Apotex Corp.
Key Facts
- Brand Name
- PAXIL CR
- Generic Name
- paroxetine hydrochloride
- NDC Code (Product)
60505-4377- Manufacturer
- Apotex Corp
- Strength
- 12.5 mg/1
- Dosage Form
- TABLET, FILM COATED, EXTENDED RELEASE
- Route
- ORAL
- Marketing Status
- Application #
- NDA020936
- Marketing Start
- 01/01/2011
Recall History
Apotex Inc.
Chemical Contamination: Product were manufactured with active pharmaceutical ingredient (API) batches contaminated with residual materials and solvents.
Apotex Inc.
Chemical Contamination: Product were manufactured with active pharmaceutical ingredient (API) batches contaminated with residual materials and solvents.
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 PAXIL CR is indicated in adults for the treatment of: Major depressive disorder (MDD) Panic disorder (PD) Social anxiety disorder (SAD) Premenstrual dysphoric disorder (PMDD) PAXIL CR is a selective serotonin reuptake inhibitor (SSRI) indicated for use in adults for the treatment of ( 1 ): Major Depressive Disorder (MDD) Panic Disorder (PD) Social Anxiety Disorder (SAD) Premenstrual Dysphoric Disorder (PMDD)
Dosage & Administration
2 DOSAGE AND ADMINISTRATION Swallow tablet whole; do not chew or crush. ( 2.1 ) Recommended starting and maximum daily dosage: (2.2, 2.3) Indication Starting Dose Maximum Dose MDD 25 mg/day 62.5 mg/day PD 12.5 mg/day 75 mg/day SAD 12.5 mg/day 37.5 mg/day PMDD 12.5 mg/day 25 mg/day For PMDD, dose continuously or intermittently (luteal phase only). ( 2.3 ) If inadequate response to starting dosage, titrate in 12.5 mg per day increments once weekly. ( 2.2 , 2.3 ) Elderly patients, patients with severe renal impairment or severe hepatic impairment: Starting dose is 12.5 mg per day. Do not exceed 50 mg per day for treatment of MDD and PD and 37.5 mg per day for treatment of SAD. ( 2.5 ) When discontinuing PAXIL CR, reduce dose gradually. ( 2.7 ) 2.1 Important Administration Instructions Administer PAXIL CR as a single daily dose in the morning, with or without food. Swallow tablets whole and do not chew or crush. 2.2 Dosage in Patients with Major Depressive Disorder, Panic Disorder, and Social Anxiety Disorder The recommended initial dosage and maximum dosage of PAXIL CR in patients with MDD, PD, and SAD are presented in Table 1. In patients with an inadequate response, dosage may be in…
Contraindications
4 CONTRAINDICATIONS PAXIL CR is contraindicated in patients: Taking, or within 14 days of stopping, MAOIs (including the MAOIs linezolid and intravenous methylene blue) because of an increased risk of serotonin syndrome [See Warnings and Precautions ( 5.2 ), Drug Interactions ( 7 )]. Taking thioridazine because of risk of QT prolongation [see Warnings and Precautions ( 5.3 ), Drug Interactions ( 7 )] . Taking pimozide because of risk of QT prolongation [see Warnings and Precautions ( 5.3 ), Drug Interactions ( 7 )]. With known hypersensitivity (e.g., anaphylaxis, angioedema, Stevens-Johnson syndrome) to paroxetine or to any of the inactive ingredients in PAXIL CR [see Adverse Reactions (6.1 , 6.2 )]. Concomitant use of monoamine oxidase inhibitors (MAOIs) or use within 14 days of discontinuing a MAOIs. ( 4 , 5. 2 , 7 ) Concomitant use of pimozide or thioridazine. ( 4 , 5.3, 7) Known hypersensitivity to paroxetine or to any of the inactive ingredients in PAXIL CR. (4)
Drug Interactions
7 DRUG INTERACTIONS Drugs Highly Bound to Plasma Protein: Monitor for adverse reactions and reduce dosage of PAXIL CR or other protein-bound drugs (e.g., warfarin) as warranted. ( 7 ) Drugs Metabolized by CYP2D6: Reduce dosage of drugs metabolized by CYP2D6 as warranted. ( 7 ) Concomitant use with Tamoxifen: Consider use of an alternative antidepressant with little or no CYP2D6 inhibition. ( 5.11 , 7 ) 7.1 Clinically Significant Drug Interactions Table 6 includes clinically significant drug interactions with PAXIL CR. Table 6: Clinically Significant Drug Interactions with PAXIL CR Monoamine Oxidase Inhibitors (MAOIs) Clinical Impact The concomitant use of SSRIs, including PAXIL CR, and MAOIs increases the risk of serotonin syndrome. Intervention PAXIL CR is contraindicated in patients taking MAOIs, including MAOIs such as linezolid or intravenous methylene blue [see Dosage and Administration ( 2.6 ), Contraindications ( 4 ), Warnings and Precautions ( 5.2 )] . Examples selegiline, tranylcypromine, isocarboxazid, phenelzine, linezolid, methylene blue Pimozide and Thioridazine Clinical Impact Increased plasma concentrations of pimozide and thioridazine, drugs with a narrow therapeuti…
Adverse Reactions
6 ADVERSE REACTIONS The following adverse reactions are included in more detail in other sections of the prescribing information: Hypersensitivity reactions to paroxetine [see Contraindications ( 4 )] Suicidal Thoughts and Behaviors [see Warnings and Precautions ( 5.1 )] Serotonin Syndrome [see Warnings and Precautions ( 5.2 )] Embryofetal and Neonatal Toxicity [see Warnings and Precautions ( 5.4 )] Increased Risk of Bleeding [see Warnings and Precautions ( 5.5 )] Activation of Mania/Hypomania [see Warnings and Precautions ( 5.6 )] Discontinuation Syndrome [see Warnings and Precautions ( 5.7 )] Seizures [see Warnings and Precautions ( 5.8 )] Angle-closure Glaucoma [see Warnings and Precautions ( 5.9 )] Hyponatremia [see Warnings and Precautions ( 5.10 )] Bone Fracture [see Warnings and Precautions ( 5.12 )] Sexual Dysfunction [see Warnings and Precautions ( 5.13 )] Most common adverse reactions (≥5% and at least twice placebo) in placebo-controlled MDD, PD, SAD, and PMDD clinical trials: abnormal ejaculation, abnormal vision, asthenia, constipation, decreased appetite, diarrhea, dizziness, dry mouth, female genital disorder, impotence, insomnia, libido decreased, nausea, somnolence…
Frequently Asked Questions
What is PAXIL CR used for?
PAXIL CR contains paroxetine hydrochloride. It is a tablet, film coated, extended release taken oral. Consult your doctor for specific uses.
Is PAXIL CR a controlled substance?
PAXIL CR is not classified as a controlled substance by the DEA.
What is the generic name for PAXIL CR?
The generic name for PAXIL CR is paroxetine hydrochloride. There are 12 other brand versions of paroxetine hydrochloride.
What is the NDC code for PAXIL CR 12.5 mg/1?
The NDC (National Drug Code) for PAXIL CR 12.5 mg/1 is 60505-4377, listed by Apotex Corp.