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Generic Name: paroxetine

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An SSRI Antidepressant - treats Anxiety, Obsessive Compulsive Disorder, Premenstrual Dysphoric Disor... more

FDA Alerts

Special Alerts:

[Posted 05/02/2007] FDA notified healthcare professionals that the Agency proposed that makers of all antidepressant medications update the existing black box warning on the prescribing information for their products to include warnings about the increased risks of suicidal thinking and behavior in young adults ages 18 to 24 years old during the first one to two months of treatment. The proposed labeling changes also state that scientific data did not show this increased risk in adults older than 24 years of age and that adults 65 years of age and older taking antidepressants have a decreased risk of suicidality. The proposed updates apply to the entire category of antidepressants. Individuals currently taking prescribed antidepressant medications should not stop taking them and should notify their healthcare professional if they have concerns. Manufacturers of antidepressant medications will have 30 days to submit their revised product labeling and revised Medication Guides to FDA for review. See the FDA press release for the list of products affected by the proposed antidepressant product labeling changes. For more information visit the FDA website at: http://www.fda.gov/medwatch/safety/2007/safety07.htm#Antidepressant, http://www.fda.gov/bbs/topics/NEWS/2007/NEW01624.html and http://www.fda.gov/cder/drug/antidepressants/default.htm.

[Posted 07/19/2006] FDA notified healthcare professionals and consumers of important information from two recent studies that should be considered when making treatment decisions in pregnant women who take antidepressants. The studies included pregnant women who were treated with selective serotonin reuptake inhibitors (SSRIs), or in a few cases, other antidepressant medications.

One study illustrated the potential risk of relapsed depression after stopping antidepressant medication during pregnancy. In this study, women who stopped their medicine were five times more likely to have a relapse of depression during their pregnancy than were women who continued to take their antidepressant medicine while pregnant.

The second study suggests there may be additional, though rare, risks of taking SSRI medications during pregnancy. This study focused on newborn babies with persistent pulmonary hypertension (PPHN), which is a serious and life-threatening lung condition that occurs soon after birth. Babies born with PPHN have high pressure in their lung blood vessels and are not able to get enough oxygen into their bloodstream. In this study, PPHN was six times more common in babies whose mothers took an SSRI antidepressant after the 20th week of pregnancy compared to babies whose mothers did not take an antidepressant. The study was too small to compare the risk of one drug compared to another. The finding of PPHN in babies of mothers who used a SSRI antidepressant in the second half of pregnancy adds to concerns from previous reports that infants of mothers taking SSRIs late in pregnancy may experience difficulties such as irritability, difficulty feeding and in very rare cases, difficulty breathing.

Additionally, the labeling for paroxetine (Paxil) was recently changed to add information about findings in an epidemiologic study that suggests that exposure to the drug in the first trimester of pregnancy may be associated with an increased risk of cardiac birth defects.

Women who are pregnant or thinking about becoming pregnant should not stop any antidepressant medication without first consulting their physician. The FDA is seeking additional information about the possible risk of PPHN in newborn babies of mothers who took SSRI antidepressants in pregnancy. FDA has asked the sponsors of all SSRIs to change prescribing information to describe the potential risk for PPHN. For more information visit the FDA website at: http://www.fda.gov/medwatch/safety/2006/safety06.htm#SSRIpreg and http://www.fda.gov/cder/drug/advisory/SSRI_PPHN200607.htm.

[Posted 07/19/2006] FDA notified healthcare professionals and consumers of new safety information regarding taking medications used to treat migraine headaches (triptans) together with certain types of antidepressant and mood disorder medications (selective serotonin reuptake inhibitors (SSRIs) and selective serotonin/norepinephrine reuptake inhibitors (SNRIs). A life-threatening condition called serotonin syndrome may occur when triptans are used together with a SSRI or a SNRI.

Serotonin syndrome occurs when the body has too much of a chemical found in the nervous system (serotonin). Each of the above medications (triptans, SSRIs, and SNRIs), cause an increase in serotonin levels. Symptoms of serotonin syndrome may include restlessness, hallucinations, loss of coordination, fast heart beat, rapid changes in blood pressure, increased body temperature, overactive reflexes, nausea, vomiting, and diarrhea.

Healthcare professionals prescribing a triptan, SSRI or SNRI should keep in mind that triptans are often used intermittently and either the triptan, SSRI or SNRI may be prescribed by a different physician; weigh the potential risk of serotonin syndrome with the expected benefit of using the above combination; discuss the possibility of serotonin syndrome with patients if a triptan and an SSRI or SNRI will be used together; and follow patients closely during treatment if a triptan and an SSRI or SNRI are used together.

Patients taking a triptan along with an SSRI or SNRI should talk to their doctor before stopping their medication and should immediately seek medical attention if they experience any of the above symptoms. FDA requested that all manufacturers of triptans, SSRIs and SNRIs update their prescribing information to warn of the possibility of serotonin syndrome when these medications are taken together. For more information visit the FDA website at: http://www.fda.gov/medwatch/safety/2006/safety06.htm#Triptans and http://www.fda.gov/cder/drug/advisory/SSRI_SS200607.htm.

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Paroxetine Hydrochloride
APO / 097 10 mg	par 879 40 mg	APO / 083 20 mg	par 876 10 mg
APO / 084 30 mg	par 877 20 mg	par 878 30 mg	101 / APO 40 mg
Paxil
PAXIL / 10 10 mg	PAXIL / 2 0 20 mg	PAXIL / 30 30 mg	PAXIL / 40 40 mg
Paxil CR
PAXIL CR / 12.5 12.5 mg	PAXIL CR / 37.5 37.5 mg	PAXIL CR / 25 25 mg

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paroxetine

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(pa ROX a teen)

Uses

Pending revision, the material in this section should be considered in light of more recently available information in the MEDWATCH notification at the beginning of this monograph.

Major Depressive Disorder

Pending revision, the material in this section should be considered in light of more recently available information in the MEDWATCH notification at the beginning of this monograph.

Management of major depressive disorder.

Efficacy in hospital settings not established.

Obsessive-Compulsive Disorder (OCD)

Management of OCD; SSRIs reduce but do not completely eliminate obsessions and compulsions.

Panic Disorder

Management of panic disorder with or without agoraphobia.

Social Phobia

Management of social phobia (social anxiety disorder).

Anxiety Disorders

Management of generalized anxiety disorder.

Posttraumatic Stress Disorder (PTSD)

Management of PTSD (alone or in combination with psychotherapy).

Premenstrual Dysphoric Disorder (PMDD)

Management of PMDD.

Premature Ejaculation

Has been used for the management of premature ejaculation†.

Diabetic Neuropathy

Has been used for the management of diabetic neuropathy†.

Chronic Headache

Has been used for the management of chronic headache†.

Dosage and Administration

General

Allow at least 2 weeks to elapse between discontinuance of an MAO inhibitor and initiation of paroxetine, and vice versa.
Monitor for possible worsening of depression or suicidality, especially at the beginning of therapy or during periods of dosage adjustments. (See Worsening of Depression and Suicidality Risk under Cautions.)
Sustained therapy may be required; monitor periodically for need for continued therapy.
Avoid abrupt discontinuance of therapy; to avoid withdrawal reactions, taper dosage gradually over a period of several weeks. (See Withdrawal of Therapy under Cautions.)
Consider cautiously tapering dosage during third trimester of pregnancy prior to delivery. (See Pregnancy under Cautions.)

Administration

Oral Administration

Administer orally once daily (in the morning) without regard to meals; however, administration with food may minimize adverse GI effects.

Shake oral suspension well just prior to administration.

Swallow extended-release tablets whole; do not chew or crush.

Dosage

Pending revision, the material in this section should be considered in light of more recently available information in the MEDWATCH notification at the beginning of this monograph.

Available as paroxetine hydrochloride; dosage expressed in terms of paroxetine.

Adults

Major Depressive Disorder

Pending revision, the material in this section should be considered in light of more recently available information in the MEDWATCH notification at the beginning of this monograph.

Oral

Conventional tablets or suspension: Initially, 20 mg once daily. If no improvement, dosage may be increased in 10-mg increments at weekly intervals.

Extended-release tablets: Initially, 25 mg once daily. If no improvement, dosage may be increased in 12.5-mg increments at weekly intervals.

Optimum duration not established; may require several months of therapy or longer. Antidepressant efficacy demonstrated for up to 1 year at mean dosage of 30 mg daily as conventional tablets or suspension, which corresponds to a 37.5 mg daily dosage as extended-release tablets.

Obsessive-Compulsive Disorder

Oral

Conventional tablets or suspension: Initially, 20 mg once daily. If no improvement, dosage may be increased in 10-mg increments at weekly intervals, to 40 mg daily.

Optimum duration not established; efficacy has been demonstrated in a 6-month relapse prevention trial. Obsessive-compulsive disorder is chronic and requires several months or longer of sustained therapy. May continue therapy in responding patients, but use lowest effective dosage and periodically reassess need for continued therapy.

Panic Disorder

Oral

Conventional tablets or suspension: Initially, 10 mg once daily. If no improvement, dosage may be increased in 10-mg increments at weekly intervals, to 40 mg daily.

Extended-release tablets: Initially, 12.5 mg once daily. If no improvement, dosage may be increased in 12.5-mg increments at weekly intervals.

Optimum duration not established; efficacy demonstrated in a 3-month relapse prevention trial. May continue therapy in responding patients, but use lowest effective dosage and periodically reassess need for continued therapy.

Social Phobia

Oral

Conventional tablets or suspension: 20 mg once daily; no additional clinical benefit was observed with higher dosages.

Extended-release tablets: Initially, 12.5 mg once daily. If dosage is increased, use increments of 12.5-mg increments at weekly intervals.

Long-term efficacy (>12 weeks) not demonstrated; may consider continuation in patient who responds, but use lowest effective dosage and periodically reassess need for continued therapy.

Anxiety Disorders

Oral

Conventional tablets or suspension: Initially, 20 mg daily; no additional clinical benefit was observed with higher dosages. If needed, dosage may be increased in 10-mg increments at weekly intervals.

Optimum duration not established; efficacy has been demonstrated in a 24-week relapse prevention trial. Generalized anxiety disorder is chronic. May continue therapy in responding patients. If used for extended periods, adjust dosage so that patients are maintained on lowest effective dosage and periodically reassess need for continued therapy.

Posttraumatic Stress Disorder

Oral

Conventional tablets or suspension: 20 mg daily; insufficient evidence to suggest greater clinical benefit with higher dosages. If needed, dosage may be increased in 10-mg increments at weekly intervals.

Consider alternative therapy if patient fails to achieve ≥25% reduction in PTSD symptoms at week 8. If >75% reduction in PTSD symptoms and response maintained for ≥3 months, may consider up to 24 months of drug therapy. If used for extended periods, adjust dosage so that patients are maintained on lowest effective dosage and periodically reassess need for continued therapy.

Premenstrual Dysphoric Disorder

Oral

Conventional tablets or suspension†: 5–30 mg daily.

Extended-release tablets: Initially, 12.5 mg once daily; may be administered daily throughout menstrual cycle or only during luteal phase. Dosage may be increased in intervals of ≥1 week. Dosages of 12.5–25 mg were effective in clinical studies.

Premature Ejaculation

Oral

Conventional tablets or suspension: 10–40 mg once daily. Alternatively, 20 mg taken 3–4 hours before planned intercourse on an “as needed” basis.†

Diabetic Neuropathy

Oral

Conventional tablets or suspension: 40 mg daily.†

Chronic Headache

Oral

Conventional tablets or suspension: 10–50 mg daily for 3–9 months.†

Prescribing Limits

Adults

Major Depressive Disorder

Oral

Conventional tablets or suspension: Maximum 50 mg daily.

Extended-release tablets: 62.5 mg daily.

Obsessive-Compulsive Disorder

Oral

Conventional tablets or suspension: Maximum 60 mg daily.

Panic Disorder

Oral

Conventional tablets or suspension: Maximum 60 mg daily.

Extended-release tablets: 75 mg daily.

Social Phobia

Oral

Extended-release tablets: 37.5 mg daily.

Special Populations

Pending revision, the material in this section should be considered in light of more recently available information in the MEDWATCH notification at the beginning of this monograph.

Dosage in Hepatic Impairment

Oral

In patients with severe hepatic impairment, an initial dosage of 10 mg daily (as conventional tablets or suspension) or 12.5 mg daily (as extended-release tablets). If no clinical improvement is apparent, dosage may be titrated with caution up to a maximum of 40 mg daily (for conventional tablets or suspension) or 50 mg (for extended-release tablets).

Dosage in Renal Impairment

Oral

In patients with severe renal impairment, an initial dosage of 10 mg daily (as conventional tablets or suspension) or 12.5 mg daily (as extended-release tablets). If no clinical improvement is apparent, dosage may be titrated with caution up to a maximum of 40 mg daily (for conventional tablets or suspension) or 50 mg (for extended-release tablets).

Geriatric or Debilitated Patients

Initially, 10 mg daily (as conventional tablets or suspension) or 12.5 mg daily (as extended-release tablets); if no clinical improvement is apparent, dosage may be titrated up to a maximum of 40 mg daily (as conventional tablets or suspension) or 50 mg daily (as extended-release tablets).

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