Parnate (Tranylcypromine) Drug Information

Tranylcypromine Description, Indications, Side Effects, Warnings, Pharmacology, and Dosage
Antidepressant Basics: Parnate

 

Generic Name: Tranylcypromine
Brand Names: • Parnate • Jatrosom

Class: Antidepressant, Monoamine Oxidase Inhibitor, Nonselective

Updated: August 2014

Parnate

What Is It?

PARNATE (TRANYLCYPROMINE) is an antidepressant drug of the monoamine oxidase inhibitor type. Parnate is distributed by Covis Pharmaceuticals, Inc., and manufactured by GlaxoSmithKline.

What Does It Treat?

PARNATE is indicated and approved by the FDA for the treatment of:
• major depressive disorder without melancholia

Off-label uses include the treatment of:
• panic disorder
• generalized anxiety disorder (GAD)
• posttraumatic stress disorder (PTSD)
• specific phobias
• migraine headaches

PARNATE should be used in adult patients who can be closely supervised. It should rarely be the first antidepressant drug given. Rather, the drug is suited for patients who have failed to respond to the drugs more commonly administered for depression.

The effectiveness of PARNATE has been established in adult outpatients, most of whom had a depressive illness which would correspond to a diagnosis of Major Depressive Episode Without Melancholia. As described in the American Psychiatric Association’s Diagnostic and Statistical Manual, third edition (DSM III), Major Depressive Episode implies a prominent and relatively persistent (nearly every day for at least 2 weeks) depressed or dysphoric mood that usually interferes with daily functioning and includes at least 4 of the following 8 symptoms: change in appetite, change in sleep, psychomotor agitation or retardation, loss of interest in usual activities or decrease in sexual drive, increased fatigability, feelings of guilt or worthlessness, slowed thinking or impaired concentration, and suicidal ideation or attempts.

The effectiveness of PARNATE in patients who meet the criteria for Major Depressive Episode with Melancholia (endogenous features) has not been established.

This medication guide does not take the place of talking to your healthcare provider about your medical condition or treatment. Talk with your healthcare provider if there is something you do not understand or want to learn more about.

Do not start or stop any medicine while taking PARNATE without talking to your healthcare provider first.

Who Should Not Take PARNATE?

Do not take PARNATE:

1) if you are allergic to tranylcypromine or any of the ingredients in PARNATE. See the end of this section for a complete list of ingredients in PARNATE;

2) if you have cerebrovascular defects or cardiovascular disorders. See Contraindications section for more details;

3) if you have a pheochromocytoma. PARNATE should not be used in the presence of pheochromocytoma since such tumors secrete pressor substances;

4) in combination with MAO inhibitors or with dibenzazepine-related entities. See Contraindications section for more details;

5) in combination with bupropion. See Contraindications section for more details;

6) in combination with selective serotonin reuptake inhibitors (SSRIs) or selective norepinephrine reuptake inhibitors (SNRIs). See Contraindications section for more details;

7) In combination with buspirone. See Contraindications section for more details;

8) in combination with sympathomimetics. See Contraindications section for more details;

9) in combination with meperidine. See Contraindications section for more details;

10) in combination with dextromethorphan. The combination of MAO inhibitors and dextromethorphan has been reported to cause brief episodes of psychosis or bizarre behavior;

11) in combination with cheese or other foods with a high tyramine content. See Contraindications section for more details;

12) in patients undergoing elective surgery. See Contraindications section for more details;

13) in combination with some central nervous system depressants such as narcotics and alcohol, or with hypotensive agents. See Contraindications section for more details;

14) in patients with a history of liver disease or in those with abnormal liver function tests;

15) in combination with caffeine in any form.

Safety and effectiveness in the pediatric population have not been established. Do not give PARNATE to anyone younger than 18 years old without the advice of a doctor.

Anti-parkinsonism drugs should be used with caution in patients receiving PARNATE since severe reactions have been reported.

Before Starting PARNATE

Tell your healthcare provider about: 1) any medical or psychiatric conditions you have, including cardiac, liver, kidney, or blood disease, seizures, or bipolar disorder; 2) current pregnancy or plans to become pregnant; 3) current breastfeeding or plans to breastfeed; 4) any and all medications and supplements you are taking; 5) any thoughts or feelings of suicide. Report any new or worsening symptoms to your doctor, such as: mood or behavior changes, anxiety, panic attacks, trouble sleeping, or if you feel impulsive, irritable, agitated, hostile, aggressive, restless, hyperactive (mentally or physically), more depressed, or have thoughts about suicide or hurting yourself.

Patients should be told that the concomitant use of PARNATE and alcohol is not advised. Patients should inform their physician if they are taking, or plan to take, any prescription or over-the-counter drugs, as there is a potential for interactions. Patients should notify their physician if they become pregnant or intend to become pregnant during therapy. Patients should notify their physician if they are breast feeding an infant. While patients may notice improvement with PARNATE therapy, they should be advised to continue therapy as directed.

Ingredients of PARNATE:

Active ingredient: tranylcypromine. Inactive ingredients consist of cellulose, citric acid, croscarmellose sodium, D&C Red No. 7, FD&C Blue No. 2, FD&C Red No. 40, FD&C Yellow No. 6, gelatin, lactose, magnesium stearate, talc, titanium dioxide, and trace amounts of other inactive ingredients.

Indications and Usage

PARNATE is indicated and approved for the treatment of major depressive episode without melancholia. Off-label uses include the treatment of panic disorder, generalized anxiety disorder (GAD), posttraumatic stress disorder (PTSD), specific phobias, migraine headaches. PARNATE should be used in adult patients who can be closely supervised. It should rarely be the first antidepressant drug given. Rather, the drug is suited for patients who have failed to respond to the drugs more commonly administered for depression.

The effectiveness of PARNATE has been established in adult outpatients, most of whom had a depressive illness which would correspond to a diagnosis of Major Depressive Episode Without Melancholia. As described in the American Psychiatric Association’s Diagnostic and Statistical Manual, third edition (DSM III), Major Depressive Episode implies a prominent and relatively persistent (nearly every day for at least 2 weeks) depressed or dysphoric mood that usually interferes with daily functioning and includes at least 4 of the following 8 symptoms: change in appetite, change in sleep, psychomotor agitation or retardation, loss of interest in usual activities or decrease in sexual drive, increased fatigability, feelings of guilt or worthlessness, slowed thinking or impaired concentration, and suicidal ideation or attempts.

The effectiveness of PARNATE in patients who meet the criteria for Major Depressive Episode with Melancholia (endogenous features) has not been established.

Do not take PARNATE:

1) if you are allergic to tranylcypromine or any of the ingredients in PARNATE. See the end of this section for a complete list of ingredients in PARNATE;

2) if you have cerebrovascular defects or cardiovascular disorders. PARNATE should not be administered to any patient with a confirmed or suspected cerebrovascular defect or to any patient with cardiovascular disease or hypertension;

3) if you have a pheochromocytoma. PARNATE should not be used in the presence of pheochromocytoma since such tumors secrete pressor substances;

4) in combination with MAO inhibitors or with dibenzazepine-related entities. PARNATE should not be administered together or in rapid succession with other MAO inhibitors or with dibenzazepine-related entities. Hypertensive crises or severe convulsive seizures may occur in patients receiving such combinations. In patients being transferred to PARNATE from another MAO inhibitor or from a dibenzazepine-related entity, allow a medication-free interval of at least a week, then initiate PARNATE using half the normal starting dosage for at least the first week of therapy. Similarly, at least a week should elapse between the discontinuance of PARNATE and the administration of another MAO inhibitor or a dibenzazepine-related entity, or the readministration of PARNATE. The following list includes some other MAO inhibitors, dibenzazepine-related entities and tricyclic antidepressants:

Furazolidone
Isocarboxazid
Pargyline HCl
Pargyline HCl and methyclothiazide
Phenelzine sulfate
Procarbazine HCl
Amitriptyline HCl
Perphenazine and amitriptyline HCl
Clomipramine hydrochloride
Desipramine HCl
Imipramine HCl
Nortriptyline HCl
Protriptyline HCl
Doxepin HCl
Carbamazepine
Cyclobenzaprine HCl
Amoxapine
Maprotiline HCl
Trimipramine maleate

5) in combination with bupropion. The concurrent administration of an MAO inhibitor and bupropion hydrochloride (Wellbutrin®, Wellbutrin SR®, Wellbutrin XL®, Zyban®, GlaxoSmithKline) is contraindicated. At least 14 days should elapse between discontinuation of an MAO inhibitor and initiation of treatment with bupropion hydrochloride;

6) in combination with selective serotonin reuptake inhibitors (SSRIs) or selective norepinephrine reuptake inhibitors (SNRIs). As a general rule, PARNATE should not be administered in combination with any SSRI or SNRI. There have been reports of serious, sometimes fatal, reactions (including hyperthermia, rigidity, myoclonus, autonomic instability with possible rapid fluctuations of vital signs, and mental status changes that include extreme agitation progressing to delirium and coma) in patients receiving a SSRI (e.g., fluoxetine) or a SNRI (e.g., venlafaxine) in combination with a monoamine oxidase inhibitor (MAOI), and in patients who have recently discontinued a SSRI or SNRI and are then started on an MAOI. Some cases presented with features resembling neuroleptic malignant syndrome. Therefore SSRIs and SNRIs should not be used in combination with an MAOI, or within 14 days of discontinuing therapy with an MAOI. Since fluoxetine and its major metabolite have very long elimination half-lives, at least 5 weeks should be allowed after stopping fluoxetine before starting an MAOI. At least 2 weeks should be allowed after stopping sertraline (Zoloft®, Pfizer) or paroxetine (Paxil®, Paxil CR®, GlaxoSmithKline) before starting an MAOI. At least one week should be allowed after stopping a SNRI (e.g., venlafaxine) before starting a MAOI;

7) In combination with buspirone. PARNATE should not be used in combination with buspirone HCl, since several cases of elevated blood pressure have been reported in patients taking MAO inhibitors who were then given buspirone HCl. At least 10 days should elapse between the discontinuation of PARNATE and the institution of buspirone HCl;

8) in combination with sympathomimetics. PARNATE should not be administered in combination with sympathomimetics, including amphetamines which may be found in many herbal preparations as well as over-the-counter drugs such as cold, hay fever or weight-reducing preparations that contain vasoconstrictors. During therapy with PARNATE, it appears that certain patients are particularly vulnerable to the effects of sympathomimetics when the activity of certain enzymes is inhibited. Use of sympathomimetics and compounds such as guanethidine, methyldopa, reserpine, dopamine, levodopa, and tryptophan with PARNATE may precipitate hypertension, headache, and related symptoms. Cerebral hemorrhage may also occur. The combination of MAOIs and tryptophan has been reported to cause behavioral and neurologic syndromes including disorientation, confusion, amnesia, delirium, agitation, hypomanic signs, ataxia, myoclonus, hyperreflexia, shivering, ocular oscillations, and Babinski’s signs;

9) in combination with meperidine. Do not use meperidine concomitantly with MAO inhibitors or within 2 or 3 weeks following MAOI therapy. Serious reactions have been precipitated with concomitant use, including coma, severe hypertension or hypotension, severe respiratory depression, convulsions, malignant hyperpyrexia, excitation, peripheral vascular collapse, and death. It is thought that these reactions may be mediated by accumulation of 5-HT (serotonin) consequent to MAO inhibition;

10) in combination with dextromethorphan. The combination of MAO inhibitors and dextromethorphan has been reported to cause brief episodes of psychosis or bizarre behavior;

11) in combination with cheese or other foods with a high tyramine content. When excessive amounts of tyramine are consumed in conjunction with tranylcypromine, or within 2 weeks of stopping treatment, a serious and sometimes fatal hypertensive reaction may occur. Tyramine occurs naturally in some foods or may occur from the bacterial breakdown of protein in foods which are fermented, aged, or spoiled. Foods that have reliably been shown to contain a high tyramine content and may also have been reported to induce a serious hypertensive reaction when consumed with tranylcypromine are: all matured or aged cheeses (note: all cheeses are considered matured or aged except fresh cottage cheese, cream cheese, ricotta, and processed cheese. All non-cheese dairy products can be consumed providing they are fresh) all aged, cured or fermented meat, fish, or poultry (note: meat, fish, or poultry that has not undergone aging, curing or fermenting and that is bought fresh, stored correctly and eaten fresh is not contraindicated) all fermented soybean products (e.g., soy sauce, miso, fermented tofu) sauerkraut, fava or broad bean pods, banana peel (but not the pulp), concentrated yeast extracts (e.g., Marmite or Vegemite spread),all tap/draught beers (note: some bottled beers, including non-alcoholic beer, may also pose a risk).

Patients should be advised to minimize or avoid use of all alcoholic beverages while taking PARNATE. Patients should be advised to adhere to the following dietary guidance about eating fresh foods: Foods may be deliberately aged as part of their processing and these are contraindicated (see list above). Foods may also naturally age over time, even if they are refrigerated. It is therefore extremely important that patients are instructed to buy and eat only fresh foods or those which have been properly frozen. They should avoid eating foods if they are unsure of their storage conditions or freshness and they should be cautious of foods of unknown age or composition even if refrigerated. The longer food is left to deteriorate and the larger the quantity of food eaten, the greater the potential quantity of tyramine ingested. Where there is any doubt, patients should be advised to either avoid the food or consume it in strict moderation if it is not otherwise contraindicated. Patients should also be warned that tyramine levels may vary by brand or even batch and a person may absorb different amounts of tyramine from a particular food at different times. Therefore, if they have accidentally consumed a prohibited food on one occasion and not had a reaction, this does not mean that they will not have a serious hypertensive reaction if they consume the same food on a different occasion;

12) in patients undergoing elective surgery. Patients taking PARNATE should not undergo elective surgery requiring general anesthesia. Also, they should not be given cocaine or local anesthesia containing sympathomimetic vasoconstrictors. The possible combined hypotensive effects of PARNATE and spinal anesthesia should be kept in mind. PARNATE should be discontinued at least 10 days prior to elective surgery;

13) in combination with some central nervous system depressants such as narcotics and alcohol, or with hypotensive agents. A marked potentiating effect on these classes of drugs has been reported;

14) in patients with a history of liver disease or in those with abnormal liver function tests;

15) in combination with caffeine in any form.

Safety and effectiveness in the pediatric population have not been established. Do not give PARNATE to anyone younger than 18 years old without the advice of a doctor.

Anti-parkinsonism drugs should be used with caution in patients receiving PARNATE since severe reactions have been reported.

Common Side Effects

Cardiovascular: Edema
Endocrine metabolic: Weight gain
Gastrointestinal: Constipation, Loss of appetite, Nausea, Xerostomia
Neurologic: Asthenia, Dizziness, Headache, Insomnia, Somnolence
Psychiatric: Agitation, Worsening, Anxiety, Worsening
Reproductive: Impotence

Serious Side Effects

Hematologic: Agranulocytosis, Anemia, Leukopenia, Thrombocytopenia
Hepatic: Hepatitis (rare )
Psychiatric: Depression, worsening (rare), Suicidal thoughts, Suicide

Get emergency medical help if you have any of these signs of an allergic reaction: skin rash or hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

PARNATE is a potent agent with the capability of producing serious side effects. PARNATE is not recommended in those depressive reactions where other antidepressant drugs may be effective. It should be reserved for patients who can be closely supervised and who have not responded satisfactorily to the drugs more commonly administered for depression.

Suicidality and Antidepressant Drugs

Antidepressants increased the risk compared to placebo of suicidal thinking and behavior (suicidality) in children, adolescents, and young adults in short-term studies of Major Depressive Disorder (MDD) and other psychiatric disorders. Anyone considering the use of PARNATE or any other antidepressant in a child, adolescent, or young adult must balance this risk with the clinical need. Short-term studies did not show an increase in the risk of suicidality with antidepressants compared to placebo in adults beyond age 24; there was a reduction in risk with antidepressants compared to placebo in adults aged 65 and older. Depression and certain other psychiatric disorders are themselves associated with increases in the risk of suicide. Patients of all ages who are started on antidepressant therapy should be monitored appropriately and observed closely for clinical worsening, suicidality, or unusual changes in behavior. Families and caregivers should be advised of the need for close observation and communication with the prescriber. PARNATE is not approved for use in pediatric patients.

Patients with major depressive disorder (MDD), both adult and pediatric, may experience worsening of their depression and/or the emergence of suicidal ideation and behavior (suicidality) or unusual changes in behavior, whether or not they are taking antidepressant medications, and this risk may persist until significant remission occurs. Suicide is a known risk of depression and certain other psychiatric disorders, and these disorders themselves are the strongest predictors of suicide. There has been a long standing concern, however, that antidepressants may have a role in inducing worsening of depression and the emergence of suicidality in certain patients during the early phases of treatment. Pooled analyses of short-term placebo-controlled trials of antidepressant drugs (SSRIs and others) showed that these drugs increase the risk of suicidal thinking and behavior (suicidality) in children, adolescents, and young adults (ages 18–24) with major depressive disorder (MDD) and other psychiatric disorders.

All patients being treated with antidepressants for any indication should be monitored appropriately and observed closely for clinical worsening, suicidality, and unusual changes in behavior, especially during the initial few months of a course of drug therapy, or at times of dose changes, either increases or decreases. Families and caregivers of patients being treated with antidepressants for major depressive disorder or other indications, both psychiatric and nonpsychiatric, should be alerted about the need to monitor patients for the emergence of agitation, irritability, unusual changes in behavior, and the other symptoms described above, as well as the emergence of suicidality, and to report such symptoms immediately to health care providers. Such monitoring should include daily observation by families and caregivers.

Hypertensive Crisis

The most important reaction associated with PARNATE is the occurrence of hypertensive crises which have sometimes been fatal. These crises are characterized by some or all of the following symptoms: occipital headache which may radiate frontally, palpitation, neck stiffness or soreness, nausea or vomiting, sweating (sometimes with fever and sometimes with cold, clammy skin), and photophobia. Either tachycardia or bradycardia may be present, and associated constricting chest pain and dilated pupils may occur. Intracranial bleeding, sometimes fatal in outcome, has been reported in association with the paradoxical increase in blood pressure.

In all patients taking PARNATE, blood pressure should be followed closely to detect evidence of any pressor response. It is emphasized that full reliance should not be placed on blood pressure readings, but that the patient should also be observed frequently. Therapy should be discontinued immediately upon the occurrence of palpitation or frequent headaches during therapy with PARNATE. These signs may be prodromal of a hypertensive crisis.

Important: Recommended treatment in hypertensive crises
If a hypertensive crisis occurs, PARNATE should be discontinued and therapy to lower blood pressure should be instituted immediately. Headache tends to abate as blood pressure is lowered. On the basis of present evidence, phentolamine is recommended. (The dosage reported for phentolamine is 5 mg I.V.) Care should be taken to administer this drug slowly in order to avoid producing an excessive hypotensive effect. Fever should be managed by means of external cooling. Other symptomatic and supportive measures may be desirable in particular cases. Do not use parenteral reserpine.

Screening Patients for Bipolar Disorder

A major depressive episode may be the initial presentation of bipolar disorder. It is generally believed (though not established in controlled trials) that treating such an episode with an antidepressant alone may increase the likelihood of precipitation of a mixed/manic episode in patients at risk for bipolar disorder. Whether any of the symptoms described above represent such a conversion is unknown. However, prior to initiating treatment with an antidepressant, patients with depressive symptoms should be adequately screened to determine if they are at risk for bipolar disorder; such screening should include a detailed psychiatric history, including a family history of suicide, bipolar disorder, and depression. It should be noted that PARNATE is not approved for use in treating bipolar depression.

Overdose

The characteristic symptoms that may be caused by overdosage include: increased anxiety, agitation, and manic symptoms is usually evidence of excessive therapeutic action. Dosage should be reduced, or a phenothiazine tranquilizer should be administered concomitantly. Patients may experience restlessness or insomnia; may notice some weakness, drowsiness, episodes of dizziness or dry mouth; or may report nausea, diarrhea, abdominal pain, or constipation. Most of these effects can be relieved by lowering the dosage or by giving suitable concomitant medication. Tachycardia, significant anorexia, edema, palpitation, blurred vision, chills, and impotence have each been reported. Headaches without blood pressure elevation have occurred. Rare instances of hepatitis, skin rash, and alopecia have been reported. Impaired water excretion compatible with the syndrome of inappropriate secretion of antidiuretic hormone (SIADH) has been reported. Tinnitus, muscle spasm, tremors, myoclonic jerks, numbness, paresthesia, urinary retention, and retarded ejaculation have been reported. Hematologic disorders including anemia, leukopenia, agranulocytosis, and thrombocytopenia have been reported.

However, an intensification of these symptoms and sometimes severe additional manifestations may be seen, depending on the degree of overdosage and on individual susceptibility. Some patients exhibit insomnia, restlessness and anxiety, progressing in severe cases to agitation, mental confusion, and incoherence. Hypotension, dizziness, weakness, and drowsiness may occur, progressing in severe cases to extreme dizziness and shock. A few patients have displayed hypertension with severe headache and other symptoms. Rare instances have been reported in which hypertension was accompanied by twitching or myoclonic fibrillation of skeletal muscles with hyperpyrexia, sometimes progressing to generalized rigidity and coma.

Call 911 or the Poison Help line at 1-800-222-1222 for all suspected overdose cases.

Pregnancy

Pregnancy Category N (Not Classified)
Use of any drug in pregnancy, during lactation or in women of childbearing age requires that the potential benefits of the drug be weighed against its possible hazards to mother and child. Animal reproductive studies show that PARNATE passes through the placental barrier into the fetus of the rat, and into the milk of the lactating dog. The absence of a harmful action of PARNATE on fertility or on postnatal development by either prenatal treatment or from the milk of treated animals has not been demonstrated. Tranylcypromine is excreted in human milk.

Pediatric Use

Safety and effectiveness in the pediatric population have not been established. Anyone considering the use of PARNATE in a child or adolescent must balance the potential risks with the clinical need.

Geriatric Use

Older patients may suffer more morbidity than younger patients during and following an episode of hypertension or malignant hyperthermia. Older patients have less compensatory reserve to cope with any serious adverse reaction. Therefore, PARNATE should be used with caution in the elderly population.

Detailed Summary

Tranylcypromine is a non-hydrazine monoamine oxidase inhibitor with a rapid onset of activity. It increases the concentration of epinephrine, norepinephrine, and serotonin in storage sites throughout the nervous system and, in theory, this increased concentration of monoamines in the brain stem is the basis for its antidepressant activity. When tranylcypromine is withdrawn, monoamine oxidase activity is recovered in 3 to 5 days, although the drug is excreted in 24 hours. Chemically, tranylcypromine sulfate is (±)-trans-2-phenylcyclopropylamine sulfate (2:1). Each round, rose-red, film-coated tablet is debossed with the product name PARNATE and SB and contains tranylcypromine sulfate equivalent to 10 mg of tranylcypromine. Inactive ingredients consist of cellulose, citric acid, croscarmellose sodium, D&C Red No. 7, FD&C Blue No. 2, FD&C Red No. 40, FD&C Yellow No. 6, gelatin, lactose, magnesium stearate, talc, titanium dioxide, and trace amounts of other inactive ingredients.

Liver Disease
PARNATE should not be used in patients with a history of liver disease or in those with abnormal liver function tests.

Renal Disease
The usual precautions should be observed in patients with impaired renal function since there is a possibility of cumulative effects in such patients.

Dosage and Administration

Dosage Forms and Strengths

PARNATE is supplied as round, rose-red, film-coated tablets debossed with the product name PARNATE and SB and contains tranylcypromine sulfate equivalent to 10 mg of tranylcypromine, in bottles of 100 with a desiccant:

• 10 mg 100’s: NDC 24987-447-10.

Major Depressive Disorder without Melancholia
Dosage should be adjusted to the requirements of the individual patient. Improvement should be seen within 48 hours to 3 weeks after starting therapy. The usual effective dosage is 30 mg per day, usually given in divided doses. If there are no signs of improvement after a reasonable period (up to 2 weeks), then the dosage may be increased in 10 mg per day increments at intervals of 1 to 3 weeks; the dosage range may be extended to a maximum of 60 mg per day from the usual 30 mg per day.

This dosage information does not include all the information needed to use PARNATE safely and effectively. See full prescribing information for PARNATE. The information at DepressionHealth.net is not a substitute for medical advice. ALWAYS consult your doctor or pharmacist.
This abridged guide is not the complete medication guide, and does not act as medical advice or replace the advice of a physician.
This guide is meant to be used as an educational tool and supplement to the expert advice and judgement of a physician.
Get emergency medical help or visit your nearest hospital if you have any of the signs of an allergic reaction when taking this medication:
skin rash or hives; difficulty breathing; swelling of your face, lips, tongue, or throat.
If you overdose, seek emergency medical attention or call the Poison Help line at 1-800-222-1222. An overdose of PARNATE can be fatal.
The above information derives from the following sources: FDA Monograph Citation NDA012342, Micromedex®, MedlinePlus, DailyMed. Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed. Disclaimer: Every effort has been made to ensure that the information provided by Depression Health Network is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This product’s label may have been updated. For current full prescribing information, please visit www.gsk.ca