Seroxat CR Paroxetine Hydrochloride Enteric-Coated Sustained-Release Tablets

1. Indications and Usage
Major Depressive Disorder (MDD):
Treatment of major depressive disorder in adults.
Obsessive-Compulsive Disorder (OCD):
Treatment of obsessive-compulsive disorder in adults.
Panic Disorder:
Treatment of panic disorder in adults.
Social Anxiety Disorder:
Treatment of social anxiety disorder in adults.
2. Dosage and Administration
Route of Administration:
For Oral Use ONLY.
Recommended Dosage:
Starting Dose: Typically 25 mg once daily.
Titration: Dose can be increased in increments (e.g., 12.5 mg/day) at intervals of at least 1 week based on clinical response and tolerability.
Maintenance: Recommended dose range is 25 mg to 62.5 mg once daily.
Maximum Dose: Typically 62.5 mg once daily.
Critical Administration Instructions:
Take with Food: Should be taken during or after a meal (breakfast is recommended) to minimize gastrointestinal side effects.
Swallow Whole: Tablets must be swallowed whole. Do not chew, crush, or split the tablets, as this will destroy the enteric-coated sustained-release structure.
3. Mechanism of Action
SSRI Activity:
Paroxetine is a potent and selective inhibitor of the neuronal reuptake of serotonin (5-hydroxytryptamine, 5-HT).
Neurotransmitter Modulation:
By blocking the serotonin transporter (SERT), it increases the concentration of serotonin in the synaptic cleft, thereby enhancing serotonergic neurotransmission.
Selectivity:
It has minimal effect on neuronal norepinephrine or dopamine reuptake at therapeutic doses.
4. Safety and Warnings
Suicidal Thoughts and Behaviors (Boxed Warning):
Antidepressants increase the risk of suicidal thinking and behavior in children, adolescents, and young adults.
Serotonin Syndrome:
Potentially life-threatening condition that can occur with serotonergic drugs.
Bleeding Risk:
SSRIs may increase the risk of bleeding events (e.g., ecchymosis, purpura, GI bleeding).
Discontinuation Syndrome:
Paroxetine has a high incidence of withdrawal symptoms (e.g., dizziness, paresthesia, anxiety, nausea) upon abrupt cessation. Gradual tapering is mandatory.
Sexual Dysfunction:
May cause decreased libido, delay or inhibition of orgasm, or erectile dysfunction.
Weight Gain:
Long-term use may be associated with weight gain.
5.Adverse Reactions
Most Common:
Nausea, somnolence, insomnia, dry mouth, decreased appetite, constipation, and sexual dysfunction.
6.Drug Interactions
MAO Inhibitors (Contraindicated):
Contraindicated within 14 days of discontinuing an MAOI.
CYP2D6 Inhibitor:
Paroxetine is a potent inhibitor of CYP2D6. It may increase the plasma levels of drugs metabolized by this enzyme (e.g., Type 1C antiarrhythmics, risperidone, atomoxetine).
Thioridazine (Contraindicated):
Contraindicated due to the risk of serious, potentially fatal, cardiac arrhythmias.
7.Pharmaceutical Information
Chemical Composition:
Active Ingredient: Paroxetine Hydrochloride.
Available Strength: 12.5 mg, 25 mg tablets.
Appearance: Film-coated tablets (colors vary by strength).
Storage: Store at controlled room temperature (20°C to 25°C).