Paroxetine CR 25 mg 30 tablets

Paroxetine CR 25 mg 30 tablets

Composition

Active ingredient: Paroxetine hydrochloride hemihydrate 28.45 mg, equivalent to 25 mg of paroxetine.

Description

Paroxetine CR is a selective serotonin reuptake inhibitor (SSRI) designed for once-daily oral administration. It features controlled-release tablets to provide gradual delivery of the active substance. It is used to treat major depressive disorder, anxiety disorders, and premenstrual dysphoric disorder in adults.

Indications for Use

Paroxetine CR is indicated for the treatment of:

-Major Depressive Disorder (MDD)

-Panic Disorder (PD)

-Social Anxiety Disorder (SAD)

-Premenstrual Dysphoric Disorder (PMDD)

Dosage and Method of Administration

Take once daily in the morning, with or without food. Swallow tablets whole, do not chew or crush.

Recommended dosages:

-MDD: Start at 25 mg/day, maximum 62.5 mg/day

-PD: Start at 12.5 mg/day, maximum 75 mg/day

-SAD: Start at 12.5 mg/day, maximum 37.5 mg/day

-Dose may be increased in 12.5 mg/day increments at weekly intervals based on tolerability.

-PMDD: Start with 12.5 mg/day; may be given continuously or during the luteal phase only. Max: 25 mg/day.

-Adjust dosage at intervals of at least 1 week.

Special populations:

-Elderly, severe renal/hepatic impairment: Start with 12.5 mg/day.

Do not exceed:

50 mg/day for MDD and PD

37.5 mg/day for SAD

-Screen for bipolar disorder prior to initiating treatment.

-Allow 14 days between stopping/starting MAOIs and Paroxetine CR.

-Taper dose gradually to discontinue.

Contraindications

-Use with MAOIs, or within 14 days of discontinuation

-Concurrent use with thioridazine or pimozide

-Known hypersensitivity to paroxetine

Precautions

-Suicidal thoughts and behaviors in adolescents and young adults

-Risk of serotonin syndrome, especially with serotonergic drugs

-Avoid in angle-closure glaucoma

-Monitor for hyponatremia

-Risk of bleeding when combined with NSAIDs, aspirin, anticoagulants

-Potential activation of mania/hypomania

-Discontinuation syndrome with abrupt stop

-Use with caution in seizure disorders

-Not recommended in pregnancy due to fetal risks (cardiac malformations, PPHN)

Side Effects

Common: nausea, headache, dry mouth, drowsiness, insomnia, fatigue, reduced libido

Discontinuation: dizziness, paresthesia, anxiety, mood swings, irritability, insomnia, tremor, confusion, etc.

Pregnancy and Breastfeeding

Not recommended during pregnancy or lactation due to risks of birth defects and neonatal complications.

Storage Conditions

Store at or below 25°C (77°F). Keep out of reach of children.

Packaging

Carton box containing 3 blisters 10 tablets each and a package insert.