Paxil CR - Comprehensive Usage Guide: instructions, indications, composition, side effects
Composition
- Active Ingredient: Paroxetine hydrochloride
- Excipients: May include dibasic calcium phosphate dihydrate, hypromellose, magnesium stearate, polyethylene glycols, sodium starch glycolate, titanium dioxide, and other inactive ingredients depending on the formulation.
Official Forms
- Controlled-Release Tablets: Available in various strengths, including 12.5 mg, 25 mg, and 37.5 mg.
Pharmacological Group
Paxil CR belongs to the pharmacological group of selective serotonin reuptake inhibitors (SSRIs) used for the treatment of depressive disorders, panic disorder, social anxiety disorder, generalized anxiety disorder, and post-traumatic stress disorder (PTSD) (ATC code: N06AB05).
Pharmacological Properties
- Pharmacodynamics: Paroxetine selectively inhibits the reuptake of serotonin, leading to increased serotonin levels in the synaptic cleft. This mechanism is thought to contribute to its antidepressant and anxiolytic effects.
- Pharmacokinetics: Paroxetine is well-absorbed after oral administration, with peak plasma concentrations achieved within 4 to 6 hours. It undergoes extensive hepatic metabolism and has an elimination half-life of approximately 21 hours.
Indications
Paxil CR is indicated for the treatment of:
- Major depressive disorder
- Panic disorder
- Social anxiety disorder (social phobia)
- Generalized anxiety disorder (GAD)
- Post-traumatic stress disorder (PTSD)
Contraindications
Paxil CR is contraindicated in individuals with:
- Hypersensitivity to paroxetine or any component of the formulation
- Concurrent use with monoamine oxidase inhibitors (MAOIs) or within 14 days of discontinuing MAOI therapy
- Severe hepatic impairment
Interactions
Paroxetine may interact with various medications, including:
- MAOIs
- Serotonergic drugs (e.g., SSRIs, tricyclic antidepressants)
- Warfarin and other drugs metabolized by cytochrome P450 enzymes
- Nonsteroidal anti-inflammatory drugs (NSAIDs)
- Tamoxifen
Specifics of Use
- Paxil CR tablets should be taken orally once daily in the morning, with or without food.
- The tablets should be swallowed whole and not chewed, crushed, or broken, as this may affect the controlled-release mechanism.
- Treatment with Paxil CR should be initiated at the lowest effective dose, with dosage adjustments made based on individual response and tolerability.
Pregnancy and Breastfeeding
Paxil CR should be used with caution during pregnancy, especially during the first trimester, and only if the potential benefits outweigh the potential risks to the fetus. It is excreted in breast milk, and breastfeeding is not recommended during Paxil CR treatment due to the potential for adverse effects in the nursing infant.
Dosage and Administration
- The recommended starting dose of Paxil CR for most indications is 25 mg once daily.
- Dosage adjustments may be necessary based on individual response and tolerability, up to a maximum dose of 62.5 mg once daily.
Overdose
In the event of Paxil CR overdose, supportive measures should be initiated, and symptomatic treatment may be necessary. Close monitoring of vital signs is essential.
Side Effects
Common side effects of Paxil CR may include:
- Nausea
- Headache
- Dizziness
- Somnolence
- Insomnia
- Dry mouth
Serious adverse effects such as serotonin syndrome, suicidal ideation, and withdrawal symptoms are rare but require immediate medical attention if they occur.
Storage and Shelf Life
- Paxil CR tablets should be stored at room temperature (20-25°C) in a dry place, protected from light and moisture.
These comprehensive instructions provide valuable information on the composition, pharmacological properties, indications, contraindications, interactions, administration, side effects, and storage of Paxil CR, facilitating safe and effective treatment of depressive and anxiety disorders. Always consult a healthcare professional for personalized medical advice.