Paxil and/or Equivalent Paroxetine Prescription Information
Paxil, which contains the active ingredient Paroxetine Hydrochloride, is a Selective Serotonin Reuptake Inhibitor (SSRI) Antidepressant drug that works by maintaining the chemical balance in the brain. Paxil has better side-effects and toxicity profiles than tricyclic antidepressant drugs. Paxil is available by prescription only.
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Paroxetine is approved for various indications as below:
Major Depressive Disorder (MDD): Paxil is approved for the treatment of Major Depressive Disorder which presents as a prominent and persistent dysphoric mood that affects daily activities for at least 2 weeks. Other MDD symptoms include altered appetite and sleep patterns, fatigue, guilt feelings, psychomotor retardation and/or agitation, impaired interest in daily life activities, decreased interest in sexual activities, impaired thinking and concentration pattern, and suicidal ideation or attempt. Patients exhibiting any of the above four symptoms simultaneously are diagnosed with MDD.
Paxil is also indicated for the treatment of various conditions as follows:
Obsessive compulsive disorder (OCD),
Social anxiety disorder (SAD),
Generalized anxiety disorder (GAD),
Posttraumatic stress disorder (PST), and
Premenstrual dysphoric disorder (PMDD).
Dose, Administration and Dosage forms:
Paxil is manufactured in immediate release tablet form in strengths of 10 mg, 20 mg, 30 mg, or 40 mg and in a suspension tablet strength of 10mg/5ml. Paxil CR is a controlled release tablet available in 12.5mg, 25mg, and 37.5mg strengths. The recommended dose for immediate release tablets is 20 to 60 mg daily and 12.5-75 mg daily for controlled release tablets. As with other antidepressant drugs, Paxil begins to take affect after a few weeks of therapy. Paxil immediate release tablets should be stored at 59-86 F (15- 30 C) while suspension and controlled release tablets should be stored below 77 F (25 C).
Mechanism of action:
Paroxetine, the active ingredient in Paxil, is a selective serotonin reuptake inhibitor which works by potentiating the serotonergic activity in the brain by inhibiting the reuptake of serotonin (5-hydroxy-tryptamine /5-HT) in the synaptic cleft. By improving serotonin neurotransmitter levels at the synaptic cleft, Paxil balances reduced serotonin in depressed patients. Studies have shown that paroxetine also has some affinity at adrenergic, dopaminergic (D2), and histaminic (H1) receptors.
Side-effects and safety profile:
The side-effect profiles reported in clinical trials with Paxil usage vary in severity and frequency. Less serious side-effects associated with Paxil usage include: nausea, vomiting, constipation, diarrhea, appetite loss, weight changes, feeling unsteady, headache, weakness, fainting, fever, agitation, drowsiness, yawning, dizziness, insomnia, trouble sleeping, suppressed sexual drive or difficulty in reaching an orgasm, dry mouth, ear ringing, etc.
Serious side-effects that have been reported with Paxil use include altered mood and behavior, severe anxiety and panic attacks, irritable and agitated moods, aggressiveness, mental and physical hyperactivity, suicidal ideation, impotence, hallucinations, high fever, bone pains and tenderness, bruising, abnormal bleeding through nasal, oral, vaginal, or rectal orifices, bloody cough, rapid heartbeats, loss of coordination, severe muscle stiffness, confusion, tremors, memory problems, confused mental state, impaired breathing and severe allergic reactions like rash, hives, inflamed face, lips, tongue, and throat, etc.
The sudden discontinuation of Paxil may result in severe withdrawal symptoms.
Paxil is classified by the FDA as a pregnancy category D drug. Paxil should be avoided during pregnancy as it may cause cardiac and lung problems in newborn babies. Women who become pregnant while taking Paxil should discontinue its use under the advice of a doctor as sudden discontinuation of Paxil may result in severe withdrawal symptoms.
As paroxetine does pass into breast milk, nursing mothers should not take Paxil.
Since Paxil, like other antidepressant drugs, is associated with an increased risk of suicidal ideation and behavior in children, adolescents, and young adults, it should be used in such patients only after a careful weighing of the risk-to-benefit ratio and with the continued close monitoring of the prescribing physician.
Physicians must be aware of patients' medical conditions such as hepatic and renal disorders, blood disorders, seizures, narrow angle glaucoma, bipolar disorders, drug abuse and suicidal ideation before prescribing Paxil.
Paxil is contraindicated with MAOI class drugs because of neuroleptic malignant syndrome.
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