Paroxetine is in a class of drugs called selective serotonin reuptake inhibitors. Paroxetine affects chemicals in the brain that may become unbalanced and cause depression, panic or anxiety, or obsessive or compulsive symptoms.
Paroxetine is used to treat major depression disorder, obsessive-compulsive disorder, panic disorder, generalized anxiety disorder, social anxiety disorder (social phobia), posttraumatic stress disorder (PTSD) and premenstrual dysphoric disorder (PMDD).
Paxil has numerous side effects on all the body systems
*Body as a Whole: Headache, Asthenia (lack or loss of strength and energy)
*Cardiovascular: Palpitation, Vasodilation (increase in the internal diameter of a blood vessel causing increased blood flow)
*Dermatologic: Sweating, Rash
*Gastrointestinal: Nausea, Dry Mouth, Constipation, Diarrhea, Decreased Appetite, Flatulence, Oropharynx Disorder (disorder o0f the throat at the back of the mouth, trouble swallowing)
*Musculoskeletal: Dyspepsia, Musculoskeletal Myopathy (disease of the muscles and bones), Myalgia (muscle pain), Myasthenia (muscle weakness)
*Nervous System: Somnolence (sleepiness), Dizziness, Insomnia, Tremor, Nervousness, Anxiety, Paresthesia (numbness and tingling in the limbs), Libido Decreased, Drugged Feeling, Confusion
*Respiration: Yawn, Rhinitis (inflammation of the nasal passages), Pharyngitis (sore throat)
*Special Senses: Blurred Vision, Taste Perversion
*Urogenital System: Ejaculatory Disturbance, Other Male Genital Disorders, Urinary Frequency, Urination Disorder, Female Genital Disorders.
Paxil has adverse interactions with many drugs. Paxil should not be taken with the following medications:
Tryptophan (please note that tryptophan is present in high quantities in turkey and milk, so caution must be taken if ingesting these foods.), MAOI's, warfaran and other blood thinners including aspirin and NSAIDS, Sumatriptan (Imitrex), Cimetidine (Tagamet), Phenobarbital, Phenytoin (Dilantin), Tricyclic Antidepressants, Alcohol, Lithium, Digoxin, Diazepam (Valium)
Patients with major depressive disorder, both adult and pediatric, may experience worsening of their depression and/or the emergence of suicidal behavior, whether or not they are taking antidepressant medications, and this risk may persist until significant remission occurs. Although there has been a longstanding concern that antidepressants may have a role in inducing worsening of depression and the emergence of suicidality in certain patients, a causal role for antidepressants in inducing such behaviors has not been established. Nevertheless, patients being treated with antidepressants should be observed closely for clinical worsening and suicidality, especially at the beginning of a course of drug therapy, or at the time of dose changes, either increases or decreases.
Paxil is in pregnancy category C. Studies in rats have resulted in deaths and damage to the fetus. There are no adequate and well-controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.
Like many other drugs, paroxetine is secreted in human milk, and caution should be exercised when PAXIL is administered to a nursing woman.
Safety and effectiveness in the pediatric population have not been established
In worldwide premarketing clinical trials with PAXIL, 17% of patients treated with PAXIL (approximately 700) were 65 years of age or older. Pharmacokinetic studies revealed a decreased clearance in the elderly, and a lower starting dose is recommended; there were, however, no overall differences in the adverse event profile between elderly and younger patients, and effectiveness was similar in younger and older patients.
Paxil is not a controlled substance.
Paxil has not been systematically studied in animals or humans for its potential for abuse, tolerance or physical dependence. While the clinical trials did not reveal any tendency for any drug-seeking behavior, these observations were not systematic and it is not possible to predict on the basis of this limited experience the extent to which a CNS-active drug will be misused, diverted, and/or abused once marketed. Consequently, patients should be evaluated carefully for history of drug abuse, and such patients should be observed closely for signs of misuse or abuse of PAXIL (e.g., development of tolerance, incrementations of dose, drug-seeking behavior).
Recommended dosage differs depending upon the condition being treated.
*Major Depressive Disorder: PAXIL should be administered as a single daily dose with or without food, usually in the morning. The recommended initial dose is 20 mg/day.
*Obsessive Compulsive Disorder: PAXIL should be administered as a single daily dose with or without food, usually in the morning. The recommended dose of PAXIL in the treatment of OCD is 40 mg daily.
*Panic Disorder: PAXIL should be administered as a single daily dose with or without food, usually in the morning. The target dose of PAXIL in the treatment of panic disorder is 40 mg/day. Patients should be started on 10 mg/day. Dose changes should occur in 10-mg/day increments and at intervals of at least 1 week.
*Social Anxiety Disorder: PAXIL should be administered as a single daily dose with or without food, usually in the morning. The recommended and initial dosage is 20 mg/day.
*Generalized Anxiety Disorder: PAXIL should be administered as a single daily dose with or without food, usually in the morning. In clinical trials the effectiveness of PAXIL was demonstrated in patients dosed in a range of 20 to 50 mg/day. The recommended starting dosage and the established effective dosage is 20 mg/day.
*Posttraumatic Stress Disorder: PAXIL should be administered as a single daily dose with or without food, usually in the morning. The recommended starting dosage and the established effective dosage is 20 mg/day.
Since the introduction of PAXIL in the United States, 342 spontaneous cases of deliberate or accidental overdosage during paroxetine treatment have been reported worldwide (circa 1999). These include overdoses with paroxetine alone and in combination with other substances. Of these, 48 cases were fatal and of the fatalities, 17 appeared to involve paroxetine alone. Eight fatal cases that documented the amount of paroxetine ingested were generally confounded by the ingestion of other drugs or alcohol or the presence of significant co-morbid conditions. The largest known ingestion involved 2,000 mg of paroxetine (33 times the maximum recommended daily dose) in a patient who recovered.
Commonly reported adverse events associated with paroxetine overdosage include somnolence (sleepiness), coma, nausea, tremor, tachycardia (rapid heartbeat), confusion, vomiting and dizziness. Other notable signs and symptoms observed with overdoses involving paroxetine (alone or with other substances) include mydriasis (excessive dilation of the pupil of the eye), convulsions, hypertension, aggressive reactions, syncope (fainting), hypotension (low blood pressure), stupor, bradycardia (slow heartbeat), dystonia (disorder of muscle tone), rhabdomyolysis (destruction of muscle cells), symptoms of hepatic (liver) dysfunction (including hepatic failure, hepatic necrosis, jaundice, hepatitis, and hepatic steatosis (fatty degeneration), manic reactions, myoclonus (muscle spasm), acute renal (kidney) failure, and urinary retention.