Antidepressants

amitriptyline (Elavil ®):

Class:  Tricyclic - Tertiary Amine

Elderly: Depression: Oral: Initial: 10-25 mg at bedtime; dose should be increased in 10-25 mg increments every week if tolerated; dose range: 25-150 mg/day

Dosing interval in hepatic impairment: Use with caution and monitor plasma levels and patient response

Supplied:  Tablet: 10 mg, 25 mg, 50 mg, 75 mg, 100 mg, 150 mg

bupropion  ( Wellbutrin ® /  Zyban ®  )

Class:  Aminoketone

Smoking cessation (Zyban®): Initiate with 150 mg once daily for 3 days; increase to 150 mg twice daily; treatment should continue for 7-12 weeks

Elderly: Depression: 50-100 mg/day, increase by 50-100 mg every 3-4 days as tolerated; there is evidence that the elderly respond at 150 mg/day in divided doses, but some may require a higher dose

Dosing adjustment/comments in renal impairment: Effect of renal disease on bupropion's pharmacokinetics has not been studied; elimination of the major metabolites of bupropion may be affected by reduced renal function. Patients with renal failure should receive a reduced dosage initially and be closely monitored.

Dosing adjustment in hepatic impairment:
Mild to moderate hepatic impairment: Use with caution and/or reduced dose/frequency.
Severe hepatic cirrhosis: Use with extreme caution; maximum dose:
Wellbutrin®: 75 mg/day
Wellbutrin SR®: 100 mg/day or 150 mg every other day
Wellbutrin XL™: 150 mg every other day
Zyban®: 150 mg every other day

Supplied:
Tablet, as hydrochloride (Wellbutrin®): 75 mg, 100 mg

Tablet, extended release, as hydrochloride (Wellbutrin XL™): 150 mg, 300 mg

Tablet, sustained release, as hydrochloride: 100 mg, 150 mg [equivalent to Wellbutrin® SR], 150 mg [equivalent to Zyban®]

Wellbutrin® SR: 100 mg, 150 mg, 200 mg

Zyban®: 150 mg

citalopram (Celexa ®): 

Class:  Selective serotonin reuptake inhibitor (SSRI)

FDA Drug Safety Communication: Abnormal heart rhythms associated with high doses of Celexa (citalopram hydrobromide) - Safety Announcement:
[8-24-2011] The U.S. Food and Drug Administration (FDA) is informing healthcare professionals and patients that the antidepressant Celexa (citalopram hydrobromide; also marketed as generics) should no longer be used at doses greater than 40 mg per day because it can cause abnormal changes in the electrical activity of the heart. Studies did not show a benefit in the treatment of depression at doses higher than 40 mg per day.

Initial: 20 mg/day, generally with an increase to 40 mg/day; doses of more than 40 mg are not usually necessary and should be avoided.

Supplied
Solution, oral: 10 mg/5 mL (240 mL) [alcohol free, sugar free; peppermint flavor]
Tablet: 10 mg, 20 mg, 40 mg

desipramine (Norpramin ®): 

Class:  Tricyclic - Secondary Amine

Elderly: Depression: Initial dose: 10-25 mg/day; increase by 10-25 mg every 3 days for inpatients and every week for outpatients if tolerated; usual maintenance dose: 75-100 mg/day, but doses up to 150 mg/day may be necessary

Monitor blood pressure and pulse rate prior to and during initial therapy evaluate mental status; monitor weight; ECG in older adults and those patients with cardiac disease; blood levels are useful for therapeutic monitoring.

Supplied
Tablet, as hydrochloride: 10 mg, 25 mg, 50 mg, 75 mg, 100 mg, 150 mg

doxepin (Sinequan ®):

Class:  Tricyclic - Tertiary Amine

Chronic urticaria, angioedema, nocturnal pruritus: Adults and Elderly: 10-30 mg/day

Dosing adjustment in hepatic impairment:
Use a lower dose and adjust gradually

Supplied
Capsule, as hydrochloride: 10 mg, 25 mg, 50 mg, 75 mg, 100 mg, 150 mg
Solution, oral concentrate, as hydrochloride (Sinequan®): 10 mg/mL (120 mL)

duloxetine (Cymbalta ® )

Class:  Norephinephrine / serotonin reuptake inhibitor

• Major Depressive Disorder (MDD)
• Generalized Anxiety Disorder (GAD)
• Diabetic Peripheral Neuropathic Pain (DPNP)
• Fibromyalgia (FM)
• Chronic Musculoskeletal Pain

DOSAGE AND ADMINISTRATION:
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Depression: Treatment of major depressive disorder: Initial: 40-60 mg/day; dose may be divided (ie, 20 or 30 mg twice daily) or given as a single daily dose of 60 mg; maximum dose: 60 mg/day

Diabetic neuropathy: 60 mg orally once daily. Lower initial doses may be considered in patients where tolerability is a concern and/or renal impairment is present.
Management of chronic pain syndromes (unlabeled use): 60 mg once daily

Management of stress incontinence (unlabeled use): 40 mg twice daily

• Some patients may benefit from starting at 30 mg once daily
• There is no evidence that doses greater than 60 mg/day confers additional benefit, while some adverse reactions were observed to be dose-dependent
• Discontinuing Cymbalta: A gradual dose reduction is recommended to avoid discontinuation symptoms

Cymbalta should generally be administered once daily without regard to meals. Cymbalta should be swallowed whole and should not be chewed or crushed, nor should the capsule be opened and its contents be sprinkled on food or mixed with liquids

Elderly: Treatment of major depressive disorder: Initial dose: 20 mg 1-2 times/day; increase to 40-60 mg/day as a single daily dose or in divided doses

WARNINGS AND PRECAUTIONS

• Suicidality: Monitor for clinical worsening and suicide risk
• Hepatotoxicity: Hepatic failure, sometimes fatal, has been reported in patients treated with Cymbalta. Cymbalta should be discontinued in patients who develop jaundice or other evidence of clinically significant liver dysfunction and should not be resumed unless another cause can be established. Cymbalta should not be prescribed to patients with substantial alcohol use or evidence of chronic liver disease
• Orthostatic Hypotension and Syncope: Cases have been reported with duloxetine therapy
• Serotonin Syndrome: Serotonin syndrome has been reported with SSRIs and SNRIs, including with Cymbalta, both when taken alone, but especially when co-administered with other serotonergic agents (including triptans, tricyclic antidepressants, fentanyl, lithium, tramadol, tryptophan, buspirone and St. John's Wort). If such symptoms occur, discontinue Cymbalta and initiate supportive treatment. If concomitant use of Cymbalta with other serotonergic drugs is clinically warranted, patients should be made aware of a potential increased risk for serotonin syndrome, particularly during treatment initiation and dose increases
• Abnormal Bleeding: Cymbalta may increase the risk of bleeding events. Patients should be cautioned about the risk of bleeding associated with the concomitant use of duloxetine and NSAIDs, aspirin, or other drugs that affect coagulation
• Severe Skin Reactions: Severe skin reactions, including erythema multiforme and Stevens-Johnson Syndrome (SJS), can occur with Cymbalta. Cymbalta should be discontinued at the first appearance of blisters, peeling rash, mucosal erosions, or any other sign of hypersensitivity if no other etiology can be identified.
• Discontinuation: May result in symptoms, including dizziness, headache, nausea, diarrhea, paresthesia, irritability, vomiting, insomnia, anxiety, hyperhidrosis, and fatigue
• Activation of mania or hypomania has occurred
• Angle-Closure Glaucoma: Angle-closure glaucoma has occurred in patients with untreated anatomically narrow angles treated with antidepressants.
• Seizures: Prescribe with care in patients with a history of seizure disorder
• Blood Pressure: Monitor blood pressure prior to initiating treatment and periodically throughout treatment
• Inhibitors of CYP1A2 or Thioridazine: Should not administer with Cymbalta
• Hyponatremia: Cases of hyponatremia have been reported
• Hepatic Insufficiency and Severe Renal Impairment: Should ordinarily not be administered to these patients
• Glucose Control in Diabetes: In diabetic peripheral neuropathic pain patients, small increases in fasting blood glucose, and HbA1c have been observed
• Conditions that Slow Gastric Emptying: Use cautiously in these patients
• Urinary Hesitation and Retention

Renal dosing:
[CRCL 30-50 ml/min]: Lower initial doses may be considered with titration guided by response and tolerability.
[< 30 ml/min]: Not recommended.

Supplied: 20 mg, 30 mg, 60 mg capsule.

escitalopram (Lexapro ® ) :

Class:  Selective serotonin reuptake inhibitor (SSRI)

• Acute and Maintenance Treatment of Major Depressive Disorder (MDD) in adults and adolescents aged 12 -17 years
• Acute Treatment of Generalized Anxiety Disorder (GAD) in adults

DOSAGE AND ADMINISTRATION
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Adults: Depression, GAD: Initial: 10 mg/day; dose may be increased to 20 mg/day after at least 1 week

• No additional benefits seen at 20 mg/day dose
• 10 mg/day is the recommended dose for most elderly patients and patients with hepatic impairment
• No dosage adjustment for patients with mild or moderate renal impairment. Use caution in patients with severe renal impairment
• Discontinuing Escitalopram : A gradual dose reduction is recommended

Elderly: 10 mg/day; bioavailability and half-life are increased by 50% in the elderly

WARNINGS AND PRECAUTIONS:

• Clinical Worsening/Suicide Risk: Monitor for clinical worsening, suicidality and unusual change in behavior, especially, during the initial few months of therapy or at times of dose changes
• Serotonin Syndrome: Serotonin syndrome has been reported with SSRIs and SNRIs, including escitalopram, both when taken alone, but especially when co-administered with other serotonergic agents (including triptans, tricyclic antidepressants, fentanyl, lithium, tramadol, tryptophan, buspirone and St. John’s Wort). If such symptoms occur, discontinue escitalopram  and initiate supportive treatment.  If concomitant use of escitalopram  with other serotonergic drugs is clinically warranted, patients should be made aware of a potential increased risk for serotonin syndrome, particularly during treatment initiation and dose increases
• Discontinuation of Treatment with Escitalopram: A gradual reduction in dose rather than abrupt cessation is recommended whenever possible
• Seizures: Prescribe with care in patients with a history of seizure
• Activation of Mania/Hypomania: Use cautiously in patients with a history of mania
• Hyponatremia: Can occur in association with SIADH
• Abnormal Bleeding: Use caution in concomitant use with NSAIDs, aspirin, warfarin or other drugs that affect coagulation
• Interference with Cognitive and Motor Performance: Use caution when operating machinery
• Use in Patients with Concomitant Illness: Use caution in patients with diseases or conditions that produce altered metabolism or hemodynamic responses

Dosage adjustment in renal impairment:
Mild to moderate impairment: No dosage adjustment needed.
Severe impairment: Clcr<20 mL/minute: Use caution.

Dosage adjustment in hepatic impairment: 10 mg/day

Supplied:
Solution, oral: 1 mg/mL (240 mL)
Tablet: 5 mg, 10 mg, 20 mg

fluoxetine (Prozac® ) : 

Class:  Selective serotonin reuptake inhibitor (SSRI)

• Acute and maintenance treatment of Major Depressive Disorder (MDD) in adult and pediatric patients aged 8 to 18 years
• Acute and maintenance treatment of Obsessive Compulsive Disorder (OCD) in adult and pediatric patients aged 7 to 17 years
• Acute and maintenance treatment of Bulimia Nervosa in adult patients
• Acute treatment of Panic Disorder, with or without agoraphobia, in adult patients

PROZAC and olanzapine in combination for:

• Acute treatment of Depressive Episodes Associated with Bipolar I Disorder
• Acute treatment of Treatment Resistant Depression in adults

DOSAGE AND ADMINISTRATION

• A lower or less frequent dosage should be used in patients with hepatic impairment, the elderly, and for patients with concurrent disease or on multiple concomitant medications
• Dosing with PROZAC Weekly capsules - initiate 7 days after the last daily dose of PROZAC 20 mg

PROZAC and olanzapine in combination:

• Dosage adjustments should be made with the individual components according to efficacy and tolerability
• Fluoxetine monotherapy is not indicated for the treatment of Depressive Episodes associated with Bipolar I Disorder or treatment resistant depression
• Safety of the coadministration of doses above 18 mg olanzapine with 75 mg fluoxetine has not been evaluated in adults
• Safety of the coadministration of doses above 12 mg olanzapine with 50 mg fluoxetine has not been evaluated in children and adolescents ages 10 to 17

Dosing (Adults): Depression, OCD, PMDD, bulimia: Initially, 20mg orally every morning - may increase after several weeks by 20 mg/day increments. Usual effective dose: 20-40mg/day. Maximum: 80mg/day.

Obsessive compulsive disorder (OCD): 40-80 mg/day.
PMDD: 20 mg/day continuously, or 20 mg/day starting 14 days prior to menstruation and through first full day of menses (repeat with each cycle).

Panic disorder: Initially, 10 mg/day. After 1 week, increase to 20 mg/day. May increase after several weeks. Doses >60 mg/day have not been evaluated.

WARNINGS AND PRECAUTIONS:

• Clinical Worsening and Suicide Risk: Monitor for clinical worsening and suicidal thinking and behavior
• Serotonin Syndrome: Serotonin syndrome has been reported with SSRIs and SNRIs, including PROZAC, both when taken alone, but especially when co-administered with other serotonergic agents (including triptans, tricyclic antidepressants, fentanyl, lithium, tramadol, tryptophan, buspirone and St. John's Wort). If such symptoms occur, discontinue PROZAC and initiate supportive treatment. If concomitant use of PROZAC with other serotonergic drugs is clinically warranted, patients should be made aware of a potential increased risk for serotonin syndrome, particularly during treatment initiation and dose increases.
• Allergic Reactions and Rash: Discontinue upon appearance of rash or allergic phenomena
• Activation of Mania/Hypomania: Screen for Bipolar Disorder and monitor for mania/hypomania
• Seizures: Use cautiously in patients with a history of seizures or with conditions that potentially lower the seizure threshold
• Altered Appetite and Weight: Significant weight loss has occurred
• Abnormal Bleeding: May increase the risk of bleeding. Use with NSAIDs, aspirin, warfarin, or other drugs that affect coagulation may potentiate the risk of gastrointestinal or other bleeding
• Angle-Closure Glaucoma: Angle-closure glaucoma has occurred in patients with untreated anatomically narrow angles treated with antidepressants.
• Hyponatremia: Has been reported with PROZAC in association with syndrome of inappropriate antidiuretic hormone (SIADH). Consider discontinuing if symptomatic hyponatremia occurs
• Anxiety and Insomnia: May occur
• QT Prolongation: QT prolongation and ventricular arrhythmia including Torsades de Pointes have been reported with PROZAC use. Use with caution in conditions that predispose to arrhythmias or increased fluoxetine exposure. Use cautiously in patients with risk factors for QT prolongation
• Potential for Cognitive and Motor Impairment: Has potential to impair judgment, thinking, and motor skills. Use caution when operating machinery
• Long Half-Life: Changes in dose will not be fully reflected in plasma for several weeks
• PROZAC and Olanzapine in Combination: When using PROZAC and olanzapine in combination, also refer to the Warnings and Precautions section of the package insert for Symbyax

[Supplied: 10, 20 mg, 40mg capsule. Long-acting delayed release capsule: 90 mg]

fluvoxamine (Luvox ®): 

Class:  Selective serotonin reuptake inhibitor (SSRI)

Dosage for Pediatric Population (children and adolescents)
The recommended starting dose for Fluvoxamine Maleate Tablets in pediatric populations (ages 8-17 years) is 25 mg, administered as a single daily dose at bedtime. In a controlled clinical trial establishing the effectiveness of Fluvoxamine Maleate Tablets in OCD, pediatric patients (ages 8-17) were titrated within a dose range of 50 to 200 mg/day. Physicians should consider age and gender differences when dosing pediatric patients. The maximum dose in children up to age 11 should not exceed 200 mg/day. Therapeutic effect in female children may be achieved with lower doses. Dose adjustment in adolescents (up to the adult maximum dose of 300 mg) may be indicated to achieve therapeutic benefit. The dose should be increased in 25 mg increments every 4 to 7 days, as tolerated, until maximum therapeutic benefit is achieved. It is advisable that a total daily dose of more than 50 mg should be given in two divided doses. If the two divided doses are not equal, the larger dose should be given at bedtime.

Dosage for Elderly or Hepatically Impaired Patients
Elderly patients and those with hepatic impairment have been observed to have a decreased clearance of fluvoxamine maleate. Consequently, it may be appropriate to modify the initial dose and the subsequent dose titration for these patient groups.

Maintenance/Continuation Extended Treatment
Although the efficacy of Fluvoxamine Maleate Tablets beyond 10 weeks of dosing for OCD has not been documented in controlled trials, OCD is a chronic condition, and it is reasonable to consider continuation for a responding patient. Dosage adjustments should be made to maintain the patient on the lowest effective dosage, and patients should be periodically reassessed to determine the need for continued treatment.

Treatment of Pregnant Women During the Third trimester
Neonates exposed to fluvoxamine maleate tablets and other SSRIs or SNRIs late in the third trimester have developed complications requiring prolonged hospitalization, respiratory support, and tube feeding. When treating pregnant women with fluvoxamine maleate tablets during the third trimester, the physician should carefully consider the potential risks and benefits of treatment. The physician may consider tapering fluvoxamine maleate tablets in the third trimester.

Discontinuation of Treatment with Fluvoxamine Maleate Tablets
Symptoms associated with discontinuation of other SSRIs and SNRIs have been reported (see package insert - PRECAUTIONS). Patients should be monitored for these symptoms when discontinuing treatment. A gradual reduction in the dose rather than abrupt cessation is recommended whenever possible. If intolerable symptoms occur following a decrease in the dose or upon discontinuation of treatment, then resuming the previously prescribed dose may be considered. Subsequently, the physician may continue decreasing the dose but at a more gradual rate.

Supplied
Tablet: 25 mg, 50 mg, 100 mg

imipramine (Tofranil ®):

Class:  cyclic - Tertiary Amine

DOSAGE AND ADMINISTRATION
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Children:
Enuresis: >/= 6 years: Initial: 25 mg at bedtime, if inadequate response still seen after 1 week of therapy, increase by 25 mg/day; dose should not exceed 2.5 mg/kg/day or 50 mg at bedtime if 6-12 years of age or 75 mg at bedtime if >/= 12 years of age

Adolescents: Depression: Initial: 30-40 mg/day; increase gradually; maximum: 100 mg/day in single or divided doses

Adults: Depression: Initial: 25 mg 3-4 times/day, increase dose gradually, total dose may be given at bedtime; maximum: 300 mg/day

Elderly: Initial: 10-25 mg at bedtime; increase by 10-25 mg every 3 days for inpatients and weekly for outpatients if tolerated; average daily dose to achieve a therapeutic concentration: 100 mg/day; range: 50-150 mg/day

Supplied
Capsule, as pamoate (Tofranil-PM®): 75 mg, 100 mg, 125 mg, 150 mg

Tablet, as hydrochloride (Tofranil®): 10 mg, 25 mg, 50 mg [generic tablets may contain sodium benzoate]

mirtazapine (Remeron ®):

Class:  Tetracyclic

Mirtazapine is a moderate peripheral α1 adrenergic antagonist, a property that may explain the occasional orthostatic hypotension reported in association with its use.

Mirtazapine is a moderate antagonist at muscarinic receptors, a property that may explain the relatively low incidence of anticholinergic side effects associated with its use.

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DOSAGE AND ADMINISTRATION
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Initial Treatment
The recommended starting dose for mirtazapine tablet, USP is 15 mg/day, administered in a single dose, preferably in the evening prior to sleep. In the controlled clinical trials establishing the efficacy of mirtazapine tablets, USP in the treatment of major depressive disorder, the effective dose range was generally 15-45 mg/day. While the relationship between dose and satisfactory response in the treatment of major depressive disorder for mirtazapine tablet, USP has not been adequately explored, patients not responding to the initial 15 mg dose may benefit from dose increases up to a maximum of 45 mg/day. Mirtazapine tablet, USP has an elimination half-life of approximately 20-40 hours; therefore, dose changes should not be made at intervals of less than one to two weeks in order to allow sufficient time for evaluation of the therapeutic response to a given dose.

Elderly and Patients with Renal or Hepatic Impairment
The clearance of mirtazapine tablet, USP is reduced in elderly patients and in patients with moderate to severe renal or hepatic impairment. Consequently, the prescriber should be aware that plasma mirtazapine tablet, USP levels may be increased in these patient groups, compared to levels observed in younger adults without renal or hepatic impairment.

Maintenance/Extended Treatment
It is generally agreed that acute episodes of depression require several months or longer of sustained pharmacological therapy beyond response to the acute episode. Systematic evaluation of mirtazapine tablets, USP has demonstrated that its efficacy in major depressive disorder is maintained for periods of up to 40 weeks following 8-12 weeks of initial treatment at a dose of 15-45 mg/day. Based on these limited data, it is unknown whether or not the dose of mirtazapine tablet, USP needed for maintenance treatment is identical to the dose needed to achieve an initial response. Patients should be periodically reassessed to determine the need for maintenance treatment and the appropriate dose for such treatment.

Switching Patients To or From a Monoamine Oxidase Inhibitor
At least 14 days should elapse between discontinuation of an MAOI and initiation of therapy with mirtazapine tablet, USP. In addition, at least 14 days should be allowed after stopping mirtazapine tablet, USP before starting an MAOI.

Dosage adjustment in renal impairment:
Clcr 11-39 mL/minute: 30% decreased clearance
Clcr<10 mL/minute: 50% decreased clearance

Dosage adjustment in hepatic impairment: Clearance decreased by 30%

Supplied: 7.5mg, 15 mg, 30 mg, 45 mg tablet. Orally-disintegrating tablet: 15 mg, 30 mg, 45 mg.

nefazodone (Serzone ®): 

Class:  Phenylpiperazine

Preclinical studies have shown that nefazodone inhibits neuronal uptake of serotonin and norepinephrine.

Nefazodone occupies central 5-HT 2 receptors at nanomolar concentrations, and acts as an antagonist at this receptor. Nefazodone was shown to antagonize alpha1-adrenergic receptors, a property which may be associated with postural hypotension. In vitro binding studies showed that nefazodone had no significant affinity for the following receptors: alpha2 and beta adrenergic, 5-HT1A, cholinergic, dopaminergic, or benzodiazepine.

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DOSAGE AND ADMINISTRATION
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When deciding among alternative treatments available for depression, the prescriber should consider the risk of hepatic failure associated with nefazodone hydrochloride tablets, USP treatment (see package insert - WARNINGS).

Initial Treatment
The recommended starting dose for nefazodone hydrochloride tablet, USP is 200 mg/day, administered in two divided doses (BID). In the controlled clinical trials establishing the antidepressant efficacy of nefazodone, the effective dose range was generally 300 to 600 mg/day. Consequently, most patients, depending on tolerability and the need for further clinical effect, should have their dose increased. Dose increases should occur in increments of 100 mg/day to 200 mg/day, again on a BID schedule, at intervals of no less than 1 week. As with all antidepressants, several weeks on treatment may be required to obtain a full antidepressant response.

Dosage for Elderly or Debilitated Patients
The recommended initial dose for elderly or debilitated patients is 100 mg/day, administered in two divided doses (BID). These patients often have reduced nefazodone clearance and/or increased sensitivity to the side effects of CNS-active drugs. It may also be appropriate to modify the rate of subsequent dose titration. As steady-state plasma levels do not change with age, the final target dose based on a careful assessment of the patient’s clinical response may be similar in healthy younger and older patients.

Maintenance/Continuation/Extended Treatment
There is no body of evidence available from controlled trials to indicate how long the depressed patient should be treated with nefazodone. It is generally agreed, however, that pharmacological treatment for acute episodes of depression should continue for up to 6 months or longer. Whether the dose of antidepressant needed to induce remission is identical to the dose needed to maintain euthymia is unknown. Systematic evaluation of the efficacy of nefazodone has shown that efficacy is maintained for periods of up to 36 weeks following 16 weeks of open-label acute treatment (treated for 52 weeks total) at dosages that averaged 438 mg/day. For most patients, their maintenance dose was that associated with response during acute treatment. (See package insert - CLINICAL PHARMACOLOGY.) The safety of nefazodone in long-term use is supported by data from both double-blind and open-label trials involving more than 250 patients treated for at least one year.

Switching Patients to or from a Monoamine Oxidase Inhibitor
At least 14 days should elapse between discontinuation of an MAOI and initiation of therapy with nefazodone. In addition, at least 7 days should be allowed after stopping nefazodone before starting an MAOI.
[Supplied: 50 mg, 100 mg, 150 mg, 200 mg, 250 mg tablet.]

nortriptyline (Pamelor ®):

Class:  Tricyclic - Secondary Amine

If a patient develops minor side effects, the dosage should be reduced. The drug should be discontinued promptly if adverse effects of a serious nature or allergic manifestations occur.

Usual Adult Dose
25 mg three or four times daily; dosage should begin at a low level and be increased as required. As an alternate regimen, the total daily dosage may be given once a day. When doses above 100 mg daily are administered, plasma levels of nortriptyline should be monitored and maintained in the optimum range of 50 to 150 ng/mL. Doses above 150 mg/day are not recommended.

Elderly and Adolescent Patients
30 to 50 mg/day in divided doses, or the total daily dosage may be given once a day.

Switching a Patient To or From a Monoamine Oxidase Inhibitor (MAOI) Intended to Treat Psychiatric Disorders
At least 14 days should elapse between discontinuation of an MAOI intended to treat psychiatric disorders and initiation of therapy with nortriptyline hydrochloride. Conversely, at least 14 days should be allowed after stopping nortriptyline hydrochloride before starting an MAOI intended to treat psychiatric disorders

Elderly ( Note: Nortriptyline is one of the best tolerated TCAs in the elderly)
Initial: 10-25 mg at bedtime.    Dosage can be increased by 25 mg every 3 days for inpatients and weekly for outpatients if tolerated.   Usual maintenance dose: 75 mg as a single bedtime dose or 2 divided doses; however, lower or higher doses may be required to stay within the therapeutic window

Chronic urticaria, angioedema, nocturnal pruritus (unlabeled use): Adults: Oral: 75 mg/day

Smoking cessation (unlabeled use): Adults: 25-75 mg/day beginning 10-14 days before "quit" day; continue therapy for >/= 12 weeks after "quit" day

Dosing adjustment in hepatic impairment: Lower doses and slower titration dependent on individualization of dosage is recommended

Supplied
Capsule, as hydrochloride: 10 mg, 25 mg, 50 mg, 75 mg

paroxetine (Paxil ®): 

Class:  Selective serotonin reuptake inhibitor (SSRI)

PTSD: Initially, 20 mg orally every morning. Usual effective dose: 20-50 mg/day. Maximum: 50mg/day.

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DOSAGE AND ADMINISTRATION
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Major Depressive Disorder
Usual Initial Dosage
Paroxetine tablets should be administered as a single daily dose with or without food, usually in the morning. The recommended initial dose is 20 mg/day. Patients were dosed in a range of 20 to 50 mg/day in the clinical trials demonstrating the effectiveness of paroxetine tablets in the treatment of major depressive disorder. As with all drugs effective in the treatment of major depressive disorder, the full effect may be delayed. Some patients not responding to a 20 mg dose may benefit from dose increases, in 10 mg/day increments, up to a maximum of 50 mg/day. Dose changes should occur at intervals of at least one week.

Maintenance Therapy
There is no body of evidence available to answer the question of how long the patient treated with paroxetine tablets should remain on it. It is generally agreed that acute episodes of major depressive disorder require several months or longer of sustained pharmacologic therapy. Whether the dose needed to induce remission is identical to the dose needed to maintain and/or sustain euthymia is unknown.

Systematic evaluation of the efficacy of paroxetine tablets has shown that efficacy is maintained for periods of up to one year with doses that averaged about 30 mg.
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Obsessive Compulsive Disorder
Usual Initial Dosage

Paroxetine tablets should be administered as a single daily dose with or without food, usually in the morning. The recommended dose of paroxetine tablets in the treatment of OCD is 40 mg daily. Patients should be started on 20 mg/day and the dose can be increased in 10 mg/day increments. Dose changes should occur at intervals of at least one week. Patients were dosed in a range of 20 to 60 mg/day in the clinical trials demonstrating the effectiveness of paroxetine tablets in the treatment of OCD. The maximum dosage should not exceed 60 mg/day.

Maintenance Therapy
Long-term maintenance of efficacy was demonstrated in a 6-month relapse prevention trial. In this trial, patients with OCD assigned to paroxetine demonstrated a lower relapse rate compared to patients on placebo. OCD is a chronic condition, and it is reasonable to consider continuation for a responding patient. Dosage adjustments should be made to maintain the patient on the lowest effective dosage, and patients should be periodically reassessed to determine the need for continued treatment.
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Panic Disorder
Usual Initial Dosage

Paroxetine tablets should be administered as a single daily dose with or without food, usually in the morning. The target dose of paroxetine tablets 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 one week. Patients were dosed in a range of 10 to 60 mg/day in the clinical trials demonstrating the effectiveness of paroxetine tablets. The maximum dosage should not exceed 60 mg/day.

Maintenance Therapy
Long-term maintenance of efficacy was demonstrated in a 3 month relapse prevention trial. In this trial, patients with panic disorder assigned to paroxetine demonstrated a lower relapse rate compared to patients on placebo. Panic disorder is a chronic condition, and it is reasonable to consider continuation for a responding patient. Dosage adjustments should be made to maintain the patient on the lowest effective dosage, and patients should be periodically reassessed to determine the need for continued treatment.
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Social Anxiety Disorder
Usual Initial Dosage

Paroxetine tablets 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. In clinical trials the effectiveness of paroxetine tablets was demonstrated in patients dosed in a range of 20 to 60 mg/day. While the safety of paroxetine tablets has been evaluated in patients with social anxiety disorder at doses up to 60 mg/day, available information does not suggest any additional benefit for doses above 20 mg/day.

Maintenance Therapy
There is no body of evidence available to answer the question of how long the patient treated with paroxetine tablets should remain on it. Although the efficacy of paroxetine tablets beyond 12 weeks of dosing has not been demonstrated in controlled clinical trials, social anxiety disorder is recognized as a chronic condition, and it is reasonable to consider continuation of treatment for a responding patient. Dosage adjustments should be made to maintain the patient on the lowest effective dosage, and patients should be periodically reassessed to determine the need for continued treatment.
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Generalized Anxiety Disorder
Usual Initial Dosage
Paroxetine tablets should be administered as a single daily dose with or without food, usually in the morning. In clinical trials the effectiveness of paroxetine tablets 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. There is not sufficient evidence to suggest a greater benefit to doses higher than 20 mg/day. Dose changes should occur in 10 mg/day increments and at intervals of at least one week.

Maintenance Therapy
Systematic evaluation of continuing paroxetine tablets for periods of up to 24 weeks in patients with Generalized Anxiety Disorder who had responded while taking paroxetine tablets during an 8 week acute treatment phase has demonstrated a benefit of such maintenance. Nevertheless, patients should be periodically reassessed to determine the need for maintenance treatment.
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Special Populations

Treatment of Pregnant Women During the Third Trimester
Neonates exposed to paroxetine tablets and other SSRIs or SNRIs, late in the third trimester have developed complications requiring prolonged hospitalization, respiratory support, and tube feeding (see package insert - WARNINGS: Usage in Pregnancy). When treating pregnant women with paroxetine during the third trimester, the physician should carefully consider the potential risks and benefits of treatment.

Dosage for Elderly or Debilitated Patients, and Patients With Severe Renal or Hepatic Impairment
The recommended initial dose is 10 mg/day for elderly patients, debilitated patients, and/or patients with severe renal or hepatic impairment. Increases may be made if indicated. Dosage should not exceed 40 mg/day.

Switching a Patient to or From a Monoamine Oxidase Inhibitor (MAOI) Intended to Treat Psychiatric Disorders
At least 14 days should elapse between discontinuation of an MAOI intended to treat psychiatric disorders and initiation of therapy with paroxetine tablets. Conversely, at least 14 days should be allowed after stopping paroxetine tablets before starting an MAOI intended to treat psychiatric disorders
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Discontinuation of Treatment with Paroxetine Tablets
Symptoms associated with discontinuation of paroxetine tablets have been reported (see package insert- PRECAUTIONS: Discontinuation of Treatment with Paroxetine Hydrochloride). Patients should be monitored for these symptoms when discontinuing treatment, regardless of the indication for which paroxetine tablets is being prescribed. A gradual reduction in the dose rather than abrupt cessation is recommended whenever possible. If intolerable symptoms occur following a decrease in the dose or upon discontinuation of treatment, then resuming the previously prescribed dose may be considered. Subsequently, the physician may continue decreasing the dose but at a more gradual rate.

Supplied: 10 mg, 20 mg, 30 mg, 40 mg tablet. Controlled release tablet: 12.5 mg, 25 mg, 37.5 mg.

Drug Update:  BRISDELLE® (paroxetine) capsules, for oral use
[Drug information ]  
Dosing:  Click (+) next to Dosage and Administration section (drug info link)

Initial U.S. Approval:  2013
BRISDELLE is a selective serotonin reuptake inhibitor (SSRI) indicated for the treatment of moderate to severe vasomotor symptoms associated with menopause (VMS) (1)
Limitation of Use: BRISDELLE is not indicated for the treatment of any psychiatric condition

Mechanism of Action:
Nonclinical studies have shown that paroxetine is an SSRI. BRISDELLE is not an estrogen, and its mechanism of action for the treatment of VMS is unknown.

sertraline (Zoloft ®): 

Class:  Selective serotonin reuptake inhibitor (SSRI)

trazodone (Desyrel ®):

Class:  Triazolopyridine

Dosing (Adults):
Depression: Initial: 150 mg/day in 3 divided doses (may increase by 50 mg/day every 3-7 days); maximum: 600 mg/day.   Dosing after meals may decrease lightheadedness and postural hypotension.

Sedation/hypnotic (unlabeled use): 25-50 mg at bedtime (often in combination with daytime SSRIs); may increase up to 200 mg at bedtime.  Dosing after meals may decrease lightheadedness and postural hypotension.

Elderly: 25-50 mg at bedtime with 25-50 mg/day dose increase every 3 days for inpatients and weekly for outpatients, if tolerated; usual dose: 75-150 mg/day

Supplied: 50 mg, 100 mg, 150 mg, 300 mg tablet.

venlafaxine (Effexor ®) 

Class:  Norephinephrine / serotonin reuptake inhibitor

Dosing: Adults:
Depression:
Immediate-release tablets: 75 mg/day, administered in 2 or 3 divided doses, taken with food; dose may be increased in 75 mg/day increments at intervals of at least 4 days, up to 225-375 mg/day

Extended-release capsules: 75 mg once daily taken with food; for some new patients, it may be desirable to start at 37.5 mg/day for 4-7 days before increasing to 75 mg once daily; dose may be increased by up to 75 mg/day increments every 4 days as tolerated, up to a maximum of 225 mg/day

GAD, social anxiety disorder: Extended-release capsules: 75 mg once daily taken with food; for some new patients, it may be desirable to start at 37.5 mg/day for 4-7 days before increasing to 75 mg once daily; dose may be increased by up to 75 mg/day increments every 4 days as tolerated, up to a maximum of 225 mg/day

Note: When discontinuing this medication after more than 1 week of treatment, it is generally recommended that the dose be tapered. If venlafaxine is used for 6 weeks or longer, the dose should be tapered over 2 weeks when discontinuing its use.

Dosing adjustment in renal impairment: Clcr 10-70 mL/minute: Decrease dose by 25%; decrease total daily dose by 50% if dialysis patients; dialysis patients should receive dosing after completion of dialysis

Dosing adjustment in moderate hepatic impairment: Reduce total daily dosage by 50%

Administration
Administer with food.
Extended release capsule: Swallow capsule whole; do not crush or chew. Alternatively, contents may be sprinkled on a spoonful of applesauce and swallowed immediately without chewing; followed with a glass of water to ensure complete swallowing of the pellets.

Supplied: 25 mg, 37.5 mg, 50 mg, 75 mg, 100 mg tablet.
37.5 mg, 75 mg, 150 mg extended release capsule.

vilazodone HCL -VIIBRYD™

CYP3A4 inhibitors: The VIIBRYD dose should be reduced to 20 mg when co-administered with CYP3A4 strong inhibitors.

CYP3A4 inducers: Concomitant use of VIIBRYD with inducers of CYP3A4 can result in inadequate drug concentrations and may diminish effectiveness. The effect of CYP3A4 inducers on systemic exposure of vilazodone has not been evaluated.

USE IN SPECIFIC POPULATIONS
Pregnancy: There are no controlled human data regarding VIIBRYD use during pregnancy. Use only if the potential benefits outweigh the potential risks.

Nursing Mothers: There are no human data regarding VIIBRYD concentrations in breast milk. Women should breast feed only if the potential benefits outweigh the potential risks.

Pediatric Use: The safety and efficacy of VIIBRYD in pediatric patients have not been studied.

Geriatric Use: No dose adjustment is recommended on the basis of age.

Hepatic Impairment: No dose adjustment is recommended in patients with mild or moderate hepatic impairment. VIIBRYD has not been studied in patients with severe hepatic impairment.

DOSAGE AND ADMINISTRATION
SUMMARY:
The recommended dose for VIIBRYD is 40 mg once daily.
VIIBRYD should be titrated to the 40 mg dose, starting with an initial dose of 10 mg once daily for 7 days, followed by 20 mg once daily for an additional 7 days, and then increased to 40 mg once daily.
VIIBRYD should be taken with food. Administration without food can result in inadequate drug concentrations and may diminish effectiveness.
When discontinuing treatment, reduce the dose gradually.
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DOSAGE AND ADMINISTRATION

Initial Treatment of Major Depressive Disorder
The recommended dose for VIIBRYD is 40 mg once daily. VIIBRYD should be titrated, starting with an initial dose of 10 mg once daily for 7 days, followed by 20 mg once daily for an additional 7 days, and then an increase to 40 mg once daily. VIIBRYD should be taken with food. VIIBRYD blood concentrations (AUC) in the fasted state can be decreased by approximately 50% compared to the fed state, and may result in diminished effectiveness in some patients.

Maintenance/Continuation/Extended Treatment
The efficacy of VIIBRYD has not been systematically studied beyond 8 weeks. It is generally agreed that acute episodes of major depressive disorder require several months or longer of sustained pharmacologic therapy. Patients should be reassessed periodically to determine the need for maintenance treatment and the appropriate dose for treatment.

Dosing in Special Populations
Pregnant Women: Neonates exposed to serotonergic antidepressants late in the third trimester have developed complications requiring prolonged hospitalization, respiratory support, and tube feeding. When treating pregnant women with VIIBRYD, consider whether the potential benefits outweigh the potential risks of treatment.

Nursing Mothers: There are no clinical data regarding the effect of VIIBRYD on lactation and nursing. Breastfeeding in women treated with VIIBRYD should be considered only if the potential benefit outweighs the potential risk.

Pediatric Patients: The safety and efficacy of VIIBRYD have not been studied in pediatric patients.

Geriatric Patients: No dose adjustment is recommended on the basis of age.

Hepatic Impairment: No dose adjustment is recommended in patients with mild or moderate hepatic impairment. VIIBRYD has not been studied in severe hepatic impairment.

Renal Impairment: No dose adjustment is recommended in patients with mild, moderate, or severe renal impairment.

Gender: No dose adjustment is recommended on the basis of gender.

Discontinuing Treatment
Discontinuation symptoms have been reported with discontinuation of serotonergic drugs such as VIIBRYD. Gradual dose reduction is recommended, instead of abrupt discontinuation, whenever possible. Monitor patients for these symptoms when discontinuing VIIBRYD. If intolerable symptoms occur following a dose decrease or upon discontinuation of treatment, consider resuming the previously prescribed dose and decreasing the dose at a more gradual rate.

Monoamine Oxidase Inhibitors (MAOI)
At least 14 days must elapse between discontinuation of an MAOI and initiation of therapy with VIIBRYD. In addition, at least 14 days must be allowed after stopping VIIBRYD before starting an MAOI.

HOW SUPPLIED
DOSAGE FORMS AND STRENGTHS
VIIBRYD Tablets are available as 10 mg, 20 mg and 40 mg immediate-release, film-coated tablets.

10 mg pink, oval tablet, debossed with 10 on one side

20 mg orange, oval tablet, debossed with 20 on one side

40 mg blue, oval tablet, debossed with 40 on one side