ترانیل سیپرومین
Tranylcypromine (Parnate)
ترانیل سیپرومین

نام ژنریک

Tranylcypromine Sulfate

شکل دارویی

اشكال دارويي:


Tablet: 10mg

موارد مصرف

موارد و مقدار مصرف


افسردگي شديد، اختلال پانيک


بزرگسالان: مقدار mg/day 30 به صورت خوراکي، در دوزهاي منقسم مصرف مي‌شود. در صورت عدم بهبودي بعد از دو هفته، مي‌توان دوز را هر 1 تا 3 هفته mg 10 افزايش داد. حداکثر دوز روزانه mg 60 مي‌باشد.


اثر درماني ترانيل سيپرومين طي 10-7 روز شروع مي‌شود، حال آن كه اثر درماني ساير مهاركننده‌هاي مونوآمين اكسيداز (MAO) طي 30-21 روز شروع مي‌گردد. همچنين، با قطع مصرف اين دارو فعاليت آنزيم مونوآمين اكسيداز سريعتر از ساير داروهاي اين گروه به ميزان پيش از درمان برمي‌گردد.

موارد منع مصرف

موارد منع مصرف و احتياط


موارد منع مصرف: اختلال تأييد شده يا احتمالي عروق مغزي، فئوکروموسيتوم، سابقه بيماري کبدي، نارسايي شديد کليوي، بيماري قلبي ـ عروقي، هايپرتانسيون، سابقه سردرد، افرادي که تحت جراحي انتخابي قرار مي‌گيرند، افرادي که هر يک از داروهاي داراي تداخل با ترانيل سيپرومين را مصرف مي‌کنند.


موارد احتياط: ديابت، بيماري پاركينسون، پركاري تيروئيد، بيماري کليوي، اختلالات تشنجي، بيماراني كه در خطر اقدام به خودکشي هستند، بيماراني که داروهاي ضد پارکينسون يا بي‌حس کننده‌هاي موضعي دريافت مي‌کنند.

عوارض جانبی دارو

عوارض جانبي


اعصاب مرکزي: سرگيجه، خواب‌آلودگي، سردرد، بيقراري، لرزش، اضطراب، کانفيوژن، گزگز اندام‌ها، ضعف.


قلبي ـ عروقي: کاهش فشارخون وضعيتي، افزايش متناقض فشارخون، تپش قلب، تاكيكاردي، ادم.


چشم، گوش: تاري ديد، وزوز گوش.


دستگاه گوارش: خشكي دهان، بي‌اشتهايي، تهوع، اسهال، يبوست،‌ درد شكمي.


ادراري ـ تناسلي: اختلال در انزال، ناتواني جنسي، احتباس ادراري.


خوني: آگرانولوسيتوز، آنمي، لکوپني، ترومبوسيتوپني.


كبد: هپاتيت.


عضلاني ـ اسکلتي: اسپاسم عضلات، پرش‌هاي ميوکلونيک.


پوست: راش.


ساير عوارض: لرز، سندرم SIADH.


مسموميت و درمان


تظاهرات باليني: تشديد عوارض جانبي و پاسخ بيش از حد به فعاليت طبيعي فارماكولوژيك ممكن است رخ دهد. اين علائم و نشانه‌ها به آهستگي (48-24 ساعت) ظاهر مي‌شوند و ممكن است تا مدت دو هفته باقي بمانند. آشفتگي، برافروختگي، تاكيكاردي، كاهش يا افزايش فشارخون، تپش قلب، افزايش فعاليت حركتي، پرش عضلات، افزايش رفلکسهاي وتري عمقي، حملات تشنجي، تب بالا، ايست قلبي ـ تنفسي يا اغما ممكن است بروز كند. مرگ با مصرف مقدار 350 ميلي‌گرم گزارش شده است.


درمان: شامل اقدامات علامتي و حمايتي است. بحران افزايش فشارخون با 10- 5 ميلي‌گرم فنتول‌آمين از راه تزريق وريدي سرشار، حملات تشنجي، آشفتگي يا لرزش با تزريق وريدي ديازپام، تاكيكاردي با بتابلوکرها و تب با پتوهاي سرد كننده درمان مي‌شود. علائم حياتي و تعادل آب و الكتروليت بايد كنترل شود. مصرف داروهاي مقلد سمپاتيك (نوراپي‌نفرين و فنيل‌افرين) در افت فشارخون (به دليل مهار مونوآمين اكسيداز) ممنوع است.

موارد قابل توجه

-

تداخل دارویی

تداخل دارويي


مصرف همزمان ترانيل سيپرومين با دوپامين، افدرين، سودوافدرين، فنيل‌افرين، فنيل‌پروپانول‌آمين، يا داروهاي وابسته ممكن است موجب بروز سردرد، هايپرتانسيون، تب و بحران افزايش فشارخون شود.


مصرف همزمان باربيتوراتها، دکسترومتورفان، اوپيوئيدها و ساير داروهاي آرام‌بخش با ترانيل سيپرومين باعث افزايش اثرات مضعف CNS مي‌شود.


مصرف همزمان اين دارو با سيتالوپرام، فلوکستين، فلووکسامين، نفازودون، پاروکستين، سرترالين يا ونلافاکسين ممکن است منجر به بروز سندرم سروتونيني شود که شامل تحريک‌پذيري CNS، لرز و تغيير سطح هوشياري مي‌باشد. بين مصرف اين داروها بايد حداقل 2 هفته فاصله باشد. در صورت نياز به مصرف ترانيل سيپرومين پس از قطع فلوکستين، حداقل 5 هفته بايد صبر نمود.


مصرف همزمان اين دارو با لوودوپا ممکن است باعث افزايش فشارخون شود.


كلاپس گردش خون و مرگ بعد از مصرف همزمان با پتدين گزارش شده‌ است.


مصرف همزمان با داروهاي بيهوش كننده عمومي يا بي‌حس‌كننده نخاعي كه به‌طور معمول توسط آنزيم MAO متابوليزه مي‌شوند، ممكن است موجب كاهش شديد فشارخون و ضعف بيش از حد CNS شود. مصرف ترانيل سيپرومين بايد حداقل 10 روز قبل از مصرف اين داروها قطع شود.


ترانيل سيپرومين اثربخشي داروهاي بي‌حس‌كننده موضعي (مانند پروكائين و ليدوكائين) را كاهش مي‌دهد و در نتيجه، انسداد عصبي ناچيزي حاصل مي‌شود.


از مصرف همزمان كوكائين يا داروهاي بي‌حس‌كننده موضعي حاوي تركيبات تنگ‌كننده عروق با اين دارو بايد اجتناب شود.


در صورت مصرف همزمان با الكل، باربيتوراتها و ساير داروهاي تسكين‌بخش، مخدرها و دكسترومتورفان، بايد مقدار مصرف ترانيل سيپرومين كاهش يابد و دارو با احتياط مصرف شود.


براي تغيير درمان از ترانيل سيپرومين به داروهاي ضد افسردگي سه‌حلقه‌اي، حداقل دو هفته وقت لازم است.


مصرف همزمان فرآورده‌هاي گياه جين سنگ (مثل Gincosan و Ginsana) با اين دارو ممکن است منجر به بروز سردرد، لرزش و مانيا شود.


مصرف همزمان الکل با اين دارو اثرات CNS را تشديد مي‌نمايد.

مکانیزم اثر

تداخل دارويي


مصرف همزمان ترانيل سيپرومين با دوپامين، افدرين، سودوافدرين، فنيل‌افرين، فنيل‌پروپانول‌آمين، يا داروهاي وابسته ممكن است موجب بروز سردرد، هايپرتانسيون، تب و بحران افزايش فشارخون شود.


مصرف همزمان باربيتوراتها، دکسترومتورفان، اوپيوئيدها و ساير داروهاي آرام‌بخش با ترانيل سيپرومين باعث افزايش اثرات مضعف CNS مي‌شود.


مصرف همزمان اين دارو با سيتالوپرام، فلوکستين، فلووکسامين، نفازودون، پاروکستين، سرترالين يا ونلافاکسين ممکن است منجر به بروز سندرم سروتونيني شود که شامل تحريک‌پذيري CNS، لرز و تغيير سطح هوشياري مي‌باشد. بين مصرف اين داروها بايد حداقل 2 هفته فاصله باشد. در صورت نياز به مصرف ترانيل سيپرومين پس از قطع فلوکستين، حداقل 5 هفته بايد صبر نمود.


مصرف همزمان اين دارو با لوودوپا ممکن است باعث افزايش فشارخون شود.


كلاپس گردش خون و مرگ بعد از مصرف همزمان با پتدين گزارش شده‌ است.


مصرف همزمان با داروهاي بيهوش كننده عمومي يا بي‌حس‌كننده نخاعي كه به‌طور معمول توسط آنزيم MAO متابوليزه مي‌شوند، ممكن است موجب كاهش شديد فشارخون و ضعف بيش از حد CNS شود. مصرف ترانيل سيپرومين بايد حداقل 10 روز قبل از مصرف اين داروها قطع شود.


ترانيل سيپرومين اثربخشي داروهاي بي‌حس‌كننده موضعي (مانند پروكائين و ليدوكائين) را كاهش مي‌دهد و در نتيجه، انسداد عصبي ناچيزي حاصل مي‌شود.


از مصرف همزمان كوكائين يا داروهاي بي‌حس‌كننده موضعي حاوي تركيبات تنگ‌كننده عروق با اين دارو بايد اجتناب شود.


در صورت مصرف همزمان با الكل، باربيتوراتها و ساير داروهاي تسكين‌بخش، مخدرها و دكسترومتورفان، بايد مقدار مصرف ترانيل سيپرومين كاهش يابد و دارو با احتياط مصرف شود.


براي تغيير درمان از ترانيل سيپرومين به داروهاي ضد افسردگي سه‌حلقه‌اي، حداقل دو هفته وقت لازم است.


مصرف همزمان فرآورده‌هاي گياه جين سنگ (مثل Gincosan و Ginsana) با اين دارو ممکن است منجر به بروز سردرد، لرزش و مانيا شود.


مصرف همزمان الکل با اين دارو اثرات CNS را تشديد مي‌نمايد.

فارماكوكینتیك

فارماكوكينتيك


جذب: از دستگاه گوارش به سرعت و به طور كامل جذب مي‌شود. اوج غلظت سرمي دارو طي 5/3-1 ساعت حاصل مي‌شود. اثر درماني دارو ممكن است تا 4-3 هفته بروز نكند.


پخش: انتشار اين دارو كاملاً مشخص نشده است. مقدار مصرف دارو بر اساس پاسخ درماني و بروز عوارض جانبي تنظيم مي‌شود.


متابوليسم: در كبد متابوليزه مي‌شود.


دفع: عمدتاً از طريق ادرار و طي 24 ساعت و مقداري از آن از طريق مجاري صفراوي در مدفوع دفع مي‌شود. با وجود اينكه نيمه‌ عمر دارو 5/2 ساعت (نسبتاً كوتاه) است، ولي مهار آنزيمي دارو طولاني است و ارتباطي به نيمه‌ عمر آن ندارد.

سایر اطلاعات

طبقه‌بندي فارماكولوژيك: مهاركننده مونوآمين اكسيداز.


طبقه‌بندي درماني: ضد افسردگي.


طبقه‌بندي مصرف در بارداري: رده C


ملاحظات اختصاصي


علاوه بر ملاحظات مربوط به تمامي مهاركننده‌هاي مونوآمين اكسيداز، رعايت موارد زير نيز توصيه مي‌شود:


1- براي جلوگيري از بروز سرگيجه (به علت تغييرات فشارخون در حالت ايستاده)، بيمار بعد از مصرف دارو بايد دراز بكشد و از تغيير وضعيت ناگهاني، بخصوص به هنگام برخاستن، خودداري كند.


2- براي کاهش خطر در بيماران داراي تمايل به خودکشي، حداقل دوز مؤثر بايد تجويز شود.


نكات قابل توصيه به بيمار


1- از مصرف فرآورده‌هاي حاوي الكل و ساير داروهاي مضعف CNS يا هرگونه فرآورده دارويي ضد سرماخوردگي، ضد تب يونجه يا كاهنده اشتها خودداري كنيد، مگر آنكه به دستور پزشك باشد.


2- براي به حداقل رساندن اثر تسكين‌بخشي در طول روز، دارو را هنگام خواب مصرف نماييد.


3- بعضي از غذاها و نوشابه‌هاي حاوي تيرامين يا تريپتوفان، مانند شراب، آبجو، پنير، كنسرو گوشت، سبزي و آب ميوه، ممكن است با اين دارو تداخل داشته باشند. از مصرف اين مواد خودداري کنيد.


4- تا مشخص شدن اثر كامل دارو بر ‍ CNS، از انجام فعاليتهاي مخاطره‌آميزي كه احتياج به هوشياري دارند خودداري كنيد.


5- دارو را طبق دستور پزشك مصرف كنيد. در صورت فراموش كردن يك نوبت مصرف دارو، از دو برابر كردن مقدار نوبت بعدي خودداري نماييد. مصرف دارو را به‌طور ناگهاني قطع نكنيد. بروز هرگونه عارضه جانبي را به پزشك اطلاع دهيد. كاهش مقدار مصرف مي‌تواند بسياري از عوارض جانبي را برطرف سازد.


6- پزشک و دندانپزشک را از مصرف اين دارو مطلع نماييد.


7- دارو را دور از دسترس كودكان نگهداري كنيد.


مصرف در سالمندان: در بيماران بزرگتر از 60 سال توصيه نمي‌شود.


مصرف در كودكان: در كودكان كوچكتر از 16 سال توصيه نمي‌شود.


مصرف در شيردهي: ايمني مصرف دارو ثابت نشده است. در دوران شيردهي اين دارو بايد با احتياط تجويز شود.


اثر بر آزمايشهاي تشخيصي


ترانيل سيپرومين نتايج آزمونهاي عملكرد كبد و غلظت كاتكول‌آمين ادرار را افزايش مي‌دهد.


اين دارو ممکن است سطح Hgb و شمارش WBC، گرانولوسيت‌ها و پلاکت‌ها را کاهش دهد.

Tranylcypromine (Parnate)

PARNATE®
(tranylcypromine sulfate) Tablets 10 mg

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 (tranylcypromine) 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 (tranylcypromine) is not approved for use in pediatric patients. (See Warnings to Physicians: Clinical Worsening and Suicide Risk, PATIENT INFORMATION, and PRECAUTIONS: Pediatric Use.)

DRUG DESCRIPTION

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.

What are the possible side effects of tranylcypromine (Parnate)?

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

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.

Stop using tranylcypromine and call your doctor at once if you have any of these serious side...

Read All Potential Side Effects and See Pictures of Parnate »

What are the precautions when taking tranylcypromine (Parnate)?

Before taking tranylcypromine, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

This medication should not be used if you have certain medical conditions. Before using this medicine, consult your doctor or pharmacist if you have: a certain kind of adrenal gland tumor (pheochromocytoma), cerebrovascular disease (e.g., stroke), heart problems (e.g., congestive heart failure, heart attack), high blood pressure, history of severe/frequent headaches, liver problems.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: personal/family history of...

Read All Potential Precautions of Parnate »

Last reviewed on RxList: 6/11/2010
This monograph has been modified to include the generic and brand name in many instances.

INDICATIONS

For the treatment of Major Depressive Episode Without Melancholia.

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

Summary of Contraindications

PARNATE (tranylcypromine) should not be administered in combination with any of the following: MAO inhibitors or dibenzazepine derivatives; sympathomimetics (including amphetamines); some central nervous system depressants (including narcotics and alcohol); antihypertensive, diuretic, antihistaminic, sedative, or anesthetic drugs; bupropion HCl; buspirone HCl; dextromethorphan; cheese or other foods with a high tyramine content; or excessive quantities of caffeine.

PARNATE (tranylcypromine) should not be administered to any patient with a confirmed or suspected cerebrovascular defect or to any patient with cardiovascular disease, hypertension, or history of headache.

(See complete discussion of CONTRAINDICATIONS and WARNINGS.)

DOSAGE AND ADMINISTRATION

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.

HOW SUPPLIED

PARNATE (tranylcypromine) 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 0007-4471-20

Store between 15° and 30°C (59° and 86°F).

GlaxoSmithKline Research Triangle Park, NC 27709. July 2008

Last reviewed on RxList: 6/11/2010
This monograph has been modified to include the generic and brand name in many instances.

SIDE EFFECTS

Overstimulation which may 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.

Post-Introduction Reports: The following are spontaneously reported adverse events temporally associated with use of PARNATE (tranylcypromine) . No clear relationship between PARNATE (tranylcypromine) and these events has been established. Localized scleroderma, flare-up of cystic acne, ataxia, confusion, disorientation, memory loss, urinary frequency, urinary incontinence, urticaria, fissuring in corner of mouth, akinesia.

Read the Parnate (tranylcypromine) Side Effects Center for a complete guide to possible side effects »

DRUG INTERACTIONS

No information provided.

Last reviewed on RxList: 6/11/2010
This monograph has been modified to include the generic and brand name in many instances.

WARNINGS

Hypertensive Crisis: The most important reaction associated with PARNATE (tranylcypromine) 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 (tranylcypromine) , 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 (tranylcypromine) . These signs may be prodromal of a hypertensive crisis.

Important: Recommended treatment in hypertensive crises

If a hypertensive crisis occurs, PARNATE (tranylcypromine) 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 IV.) 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.

PRECAUTIONS

Hypotension: Hypotension has been observed during therapy with PARNATE (tranylcypromine) . Symptoms of postural hypotension are seen most commonly but not exclusively in patients with pre-existent hypertension; blood pressure usually returns rapidly to pretreatment levels upon discontinuation of the drug. At doses above 30 mg daily, postural hypotension is a major side effect and may result in syncope. Dosage increases should be made more gradually in patients showing a tendency toward hypotension at the beginning of therapy. Postural hypotension may be relieved by having the patient lie down until blood pressure returns to normal.

Also, when PARNATE (tranylcypromine) is combined with those phenothiazine derivatives or other compounds known to cause hypotension, the possibility of additive hypotensive effects should be considered.

There have been reports of drug dependency in patients using doses of tranylcypromine significantly in excess of the therapeutic range. Some of these patients had a history of previous substance abuse. The following withdrawal symptoms have been reported: restlessness, anxiety, depression, confusion, hallucinations, headache, weakness, and diarrhea.

Drugs which lower the seizure threshold, including MAO inhibitors, should not be used with Amipaque®*. As with other MAO inhibitors, PARNATE (tranylcypromine) should be discontinued at least 48 hours before myelography and should not be resumed for at least 24 hours postprocedure.

MAO inhibitors may have the capacity to suppress anginal pain that would otherwise serve as a warning of myocardial ischemia.

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

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 (tranylcypromine) should be used with caution in the elderly population.

Although excretion of PARNATE (tranylcypromine) is rapid, inhibition of MAO may persist up to 10 days following discontinuation.

Because the influence of PARNATE (tranylcypromine) on the convulsive threshold is variable in animal experiments, suitable precautions should be taken if epileptic patients are treated.

Some MAO inhibitors have contributed to hypoglycemic episodes in diabetic patients receiving insulin or oral hypoglycemic agents. Therefore, PARNATE (tranylcypromine) should be used with caution in diabetics using these drugs.

PARNATE (tranylcypromine) may aggravate coexisting symptoms in depression, such as anxiety and agitation.

Use PARNATE (tranylcypromine) with caution in hyperthyroid patients because of their increased sensitivity to pressor amines.

PARNATE (tranylcypromine) should be administered with caution to patients receiving Antabuse®. In a single study, rats given high intraperitoneal doses of d or l isomers of tranylcypromine sulfate plus disulfiram experienced severe toxicity including convulsions and death. Additional studies in rats given high oral doses of racemic tranylcypromine sulfate (PARNATE (tranylcypromine) ) and disulfiram produced no adverse interaction.

Information for Patients: Prescribers or other health professionals should inform patients, their families, and their caregivers about the benefits and risks associated with treatment with PARNATE (tranylcypromine) and should counsel them in its appropriate use. A patient Medication Guide about “Antidepressant Medicines, Depression and Other Serious Mental Illnesses, and Suicidal Thoughts or Actions” is available for PARNATE (tranylcypromine) . The prescriber or health professional should instruct patients, their families, and their caregivers to read the Medication Guide and should assist them in understanding its contents. Patients should be given the opportunity to discuss the contents of the Medication Guide and to obtain answers to any questions they may have. The complete text of the Medication Guide is reprinted at the end of this document.

Patients should be advised of the following issues and asked to alert their prescriber if these occur while taking PARNATE (tranylcypromine) .

Clinical Worsening and Suicide Risk: Patients, their families, and their caregivers should be encouraged to be alert to the emergence of anxiety, agitation, panic attacks, insomnia, irritability, hostility, aggressiveness, impulsivity, akathisia (psychomotor restlessness), hypomania, mania, other unusual changes in behavior, worsening of depression, and suicidal ideation, especially early during antidepressant treatment and when the dose is adjusted up or down. Families and caregivers of patients should be advised to look for the emergence of such symptoms on a day-to-day basis, since changes may be abrupt. Such symptoms should be reported to the patient's prescriber or health professional, especially if they are severe, abrupt in onset, or were not part of the patient's presenting symptoms. Symptoms such as these may be associated with an increased risk for suicidal thinking and behavior and indicate a need for very close monitoring and possibly changes in the medication.

Pediatric Use: Safety and effectiveness in the pediatric population have not been established (see BOX WARNING and WARNINGS - Clinical Worsening and Suicide Risk). Anyone considering the use of PARNATE (tranylcypromine) in a child or adolescent must balance the potential risks with the clinical need.

*metrizamide, The Sanofi-Aventis Group.
disulfiram, Odyssey Pharmaceuticals, Inc.

Last reviewed on RxList: 6/11/2010
This monograph has been modified to include the generic and brand name in many instances.

OVERDOSE

Symptoms: The characteristic symptoms that may be caused by overdosage are usually those described above.

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.

Treatment: Because strategies for the management of overdose are continually evolving, it is advisable to contact a Poison Control Center to determine the latest recommendations for the management of an overdose of any drug. Telephone numbers for the certified Poison Control Centers are listed in the Physicians' Desk Reference (PDR).

Treatment should normally consist of general supportive measures, close observation of vital signs and steps to counteract specific symptoms as they occur, since MAO inhibition may persist. The management of hypertensive crises is described under WARNINGS in the HYPERTENSIVE CRISES section.

External cooling is recommended if hyperpyrexia occurs. Barbiturates have been reported to help relieve myoclonic reactions, but frequency of administration should be controlled carefully because PARNATE (tranylcypromine) may prolong barbiturate activity. When hypotension requires treatment, the standard measures for managing circulatory shock should be initiated. If pressor agents are used, the rate of infusion should be regulated by careful observation of the patient because an exaggerated pressor response sometimes occurs in the presence of MAO inhibition. Remember that the toxic effect of PARNATE (tranylcypromine) may be delayed or prolonged following the last dose of the drug. Therefore, the patient should be closely observed for at least a week. It is not known if tranylcypromine is dialyzable.

CONTRAINDICATIONS

PARNATE (tranylcypromine) is contraindicated:

In patients with cerebrovascular defects or cardiovascular disorders

PARNATE (tranylcypromine) should not be administered to any patient with a confirmed or suspected cerebrovascular defect or to any patient with cardiovascular disease or hypertension.

In the presence of pheochromocytoma

PARNATE (tranylcypromine) should not be used in the presence of pheochromocytoma since such tumors secrete pressor substances.

In combination with MAO inhibitors or with dibenzazepine-related entities

PARNATE (tranylcypromine) 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 (tranylcypromine) from another MAO inhibitor or from a dibenzazepine-related entity, allow a medication-free interval of at least a week, then initiate PARNATE (tranylcypromine) 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 (tranylcypromine) and the administration of another MAO inhibitor or a dibenzazepine-related entity, or the readministration of PARNATE (tranylcypromine) .

The following list includes some other MAO inhibitors, dibenzazepine-related entities and tricyclic antidepressants, and the companies which market them.

Other MAO Inhibitors

Generic Name Source
Furazolidone  
Isocarboxazid Marplan® (Oxford Pharm Services)
Pargyline HCl  
Pargyline HCl and methyclothiazide  
Phenelzine sulfate Nardil® (Pfizer)
Procarbazine HCl Matulane® (Sigma Tau)
Dibenzazepine-Related and Other Tricyclics
Generic Name Source
Amitriptyline HCl (Sandoz)
Perphenazine and amitriptyline HCl (Sandoz)
Clomipramine hydrochloride Anafranil® (Mallinckrodt)
Desipramine HCl (Sandoz)
Imipramine HCl (Sandoz)
Nortriptyline HCl Tofranil® (Mallinckrodt) (Mylan)
  Pamelor® (Mallinckrodt)
Protriptyline HCl Vivactil® (Odyssey Pharmaceuticals, Inc.)
Doxepin HCl Sinequan® (Pfizer)
Carbamazepine Tegretol® (Novartis)
Cyclobenzaprine HCl (Mylan)
  Flexeril® (McNeil)
Amoxapine (Watson)
Maprotiline HCl (Mylan)
Trimipramine maleate Surmontil® (Odyssey Pharmaceuticals, Inc.)

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.

In combination with selective serotonin reuptake inhibitors (SSRIs) or selective norepinephrine reuptake inhibitors (SNRIs)

As a general rule, PARNATE (tranylcypromine) 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, Prozac®, Eli Lilly and Company) or a SNRI (e.g., venlafaxine, Effexor®, Effexor XR®, Wyeth) 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.

In combination with buspirone

PARNATE (tranylcypromine) 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 (tranylcypromine) and the institution of buspirone HCl.

In combination with sympathomimetics

PARNATE (tranylcypromine) 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 (tranylcypromine) , 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 (tranylcypromine) 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.

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.

In combination with dextromethorphan

The combination of MAO inhibitors and dextromethorphan has been reported to cause brief episodes of psychosis or bizarre behavior.

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 (tranylcypromine) . 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.

In patients undergoing elective surgery

Patients taking PARNATE (tranylcypromine) 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 (tranylcypromine) and spinal anesthesia should be kept in mind. PARNATE (tranylcypromine) should be discontinued at least 10 days prior to elective surgery.

Additional Contraindications

In general, the physician should bear in mind the possibility of a lowered margin of safety when PARNATE (tranylcypromine) is administered in combination with potent drugs.

  1. PARNATE (tranylcypromine) should not be used 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.
  2. Anti-parkinsonism drugs should be used with caution in patients receiving PARNATE (tranylcypromine) since severe reactions have been reported.
  3. PARNATE (tranylcypromine) should not be used in patients with a history of liver disease or in those with abnormal liver function tests.
  4. Excessive use of caffeine in any form should be avoided in patients receiving PARNATE (tranylcypromine) .

Warnings to Physicians

Clinical Worsening and Suicide Risk: 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. 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 with antidepressants compared to placebo in adults aged 65 and older.

The pooled analyses of placebo-controlled trials in children and adolescents with MDD, obsessive compulsive disorder (OCD), or other psychiatric disorders included a total of 24 short-term trials of 9 antidepressant drugs in over 4,400 patients. The pooled analyses of placebo-controlled trials in adults with MDD or other psychiatric disorders included a total of 295 short-term trials (median duration of 2 months) of 11 antidepressant drugs in over 77,000 patients. There was considerable variation in risk of suicidality among drugs, but a tendency toward an increase in the younger patients for almost all drugs studied. There were differences in absolute risk of suicidality across the different indications, with the highest incidence in MDD. The risk differences (drug vs placebo), however, were relatively stable within age strata and across indications. These risk differences (drug-placebo difference in the number of cases of suicidality per 1,000 patients treated) are provided in Table 1.

Table 1

Age Range Drug-Placebo Difference in Number of Cases of Suicidality per 1,000 Patients Treated
Increases Compared to Placebo
< 18 14 additional cases
18-24 5 additional cases
Decreases Compared to Placebo
25-64 1 fewer case
≥ 65 6 fewer cases

No suicides occurred in any of the pediatric trials. There were suicides in the adult trials, but the number was not sufficient to reach any conclusion about drug effect on suicide.

It is unknown whether the suicidality risk extends to longer-term use, i.e., beyond several months. However, there is substantial evidence from placebo-controlled maintenance trials in adults with depression that the use of antidepressants can delay the recurrence of depression.

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.

The following symptoms, anxiety, agitation, panic attacks, insomnia, irritability, hostility, aggressiveness, impulsivity, akathisia (psychomotor restlessness), hypomania, and mania, have been reported in adult and pediatric patients being treated with antidepressants for major depressive disorder as well as for other indications, both psychiatric and nonpsychiatric. Although a causal link between the emergence of such symptoms and either the worsening of depression and/or the emergence of suicidal impulses has not been established, there is concern that such symptoms may represent precursors to emerging suicidality.

Consideration should be given to changing the therapeutic regimen, including possibly discontinuing the medication, in patients whose depression is persistently worse, or who are experiencing emergent suicidality or symptoms that might be precursors to worsening depression or suicidality, especially if these symptoms are severe, abrupt in onset, or were not part of the patient's presenting symptoms.

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 healthcare providers. Such monitoring should include daily observation by families and caregivers.

Prescriptions for PARNATE (tranylcypromine) should be written for the smallest quantity of tablets consistent with good patient management, in order to reduce the risk of overdose.

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 (tranylcypromine) is not approved for use in treating bipolar depression.

PARNATE (tranylcypromine) is a potent agent with the capability of producing serious side effects.

PARNATE (tranylcypromine) 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.

Before prescribing, the physician should be completely familiar with the full material on dosage, side effects, and contraindications on these pages, with the principles of MAO inhibitor therapy and the side effects of this class of drugs. Also, the physician should be familiar with the symptomatology of mental depressions and alternate methods of treatment to aid in the careful selection of patients for therapy with PARNATE (tranylcypromine) .

Pregnancy Warning: 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 (tranylcypromine) 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 (tranylcypromine) 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.

Warning to the Patient

Patients should be instructed to report promptly the occurrence of headache or other unusual symptoms, i.e., palpitation and/or tachycardia, a sense of constriction in the throat or chest, sweating, dizziness, neck stiffness, nausea, or vomiting.

Patients should be warned against eating the foods listed in Section 11 under Contraindications while on therapy with PARNATE (tranylcypromine) . Also, they should be told not to drink alcoholic beverages. The patient should also be warned about the possibility of hypotension and faintness, as well as drowsiness sufficient to impair performance of potentially hazardous tasks such as driving a car or operating machinery.

Patients should also be cautioned not to take concomitant medications, whether prescription or over-the-counter drugs such as cold, hay fever, or weight-reducing preparations, without the advice of a physician. They should be advised not to consume excessive amounts of caffeine in

any form. Likewise, they should inform other physicians, and their dentist, about their use of PARNATE.

See PATIENT INFORMATION for information regarding clinical worsening and suicide risk.

Last reviewed on RxList: 6/11/2010
This monograph has been modified to include the generic and brand name in many instances.

CLINICAL PHARMACOLOGY

Action

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.

Last reviewed on RxList: 6/11/2010
This monograph has been modified to include the generic and brand name in many instances.

PATIENT INFORMATION

Medication Guide
Antidepressant Medicines, Depression and Other Serious Mental Illnesses, and Suicidal
Thoughts or Actions

PARNATE®
(PAR-nate)
(tranylcypromine sulfate) Tablets

Read the Medication Guide that comes with you or your family member's antidepressant medicine. This Medication Guide is only about the risk of suicidal thoughts and actions with antidepressant medicines Talk to your, or your family member's, healthcare provider about:

  • All risks and benefits of treatment with antidepressant medicines
  • All treatment choices for depression or other serious mental illness

What is the most important information I should know about antidepressant medicines, depression and other serious mental illnesses, and suicidal thoughts or actions?

  1. Antidepressant medicines may increase suicidal thoughts or actions in some children, teenagers, and young adults within the first few months of treatment.
  2. Depression and other serious mental illnesses are the most important causes of suicidal thoughts and actions. Some people may have a particularly high risk of having suicidal thoughts or actions. These include people who have (or have a family history of) bipolar illness (also called manic-depressive illness) or suicidal thoughts or actions.
  3. How can I watch for and try to prevent suicidal thoughts and actions in myself or a family member?
    • Pay close attention to any changes, especially sudden changes, in mood, behaviors, thoughts, or feelings. This is very important when an antidepressant medicine is started or when the dose is changed.
    • Call the healthcare provider right away to report new or sudden changes in mood, behavior, thoughts, or feelings.
    • Keep all follow-up visits with the healthcare provider as scheduled. Call the healthcare provider between visits as needed, especially if you have concerns about symptoms.

Call a healthcare provider right away if you or your family member has any of the following symptoms, especially if they are new, worse, or worry you:

  • Thoughts about suicide or dying
  • Attempts to commit suicide
  • New or worse depression
  • New or worse anxiety
  • Feeling very agitated or restless
  • Panic attacks
  • Trouble sleeping (insomnia)
  • New or worse irritability
  • Acting aggressive, being angry, or violent
  • Acting on dangerous impulses
  • An extreme increase in activity and talking (mania)
  • Other unusual changes in behavior or mood

What else do I need to know about antidepressant medicines?

  • Never stop an antidepressant medicine without first talking to a healthcare provider.
    Stopping an antidepressant medicine suddenly can cause other symptoms.
  • Antidepressants are medicines used to treat depression and other illnesses. It is important to discuss all the risks of treating depression and also the risks of not treating it. Patients and their families or other caregivers should discuss all treatment choices with the healthcare provider, not just the use of antidepressants.
  • Antidepressant medicines have other side effects. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
  • Antidepressant medicines can interact with other medicines. Know all of the medicines that you or your family member takes. Keep a list of all medicines to show the healthcare provider. Do not start new medicines without first checking with your healthcare provider.
  • Not all antidepressant medicines prescribed for children are FDA approved for use in children. Talk to your child's healthcare provider for more information.

This Medication Guide has been approved by the U.S. Food and Drug Administration for all antidepressants.

Last reviewed on RxList: 6/11/2010
This monograph has been modified to include the generic and brand name in many instances.

>

PATIENT INFORMATION

Medication Guide
Antidepressant Medicines, Depression and Other Serious Mental Illnesses, and Suicidal
Thoughts or Actions

PARNATE®
(PAR-nate)
(tranylcypromine sulfate) Tablets

Read the Medication Guide that comes with you or your family member's antidepressant medicine. This Medication Guide is only about the risk of suicidal thoughts and actions with antidepressant medicines Talk to your, or your family member's, healthcare provider about:

  • All risks and benefits of treatment with antidepressant medicines
  • All treatment choices for depression or other serious mental illness

What is the most important information I should know about antidepressant medicines, depression and other serious mental illnesses, and suicidal thoughts or actions?

  1. Antidepressant medicines may increase suicidal thoughts or actions in some children, teenagers, and young adults within the first few months of treatment.
  2. Depression and other serious mental illnesses are the most important causes of suicidal thoughts and actions. Some people may have a particularly high risk of having suicidal thoughts or actions. These include people who have (or have a family history of) bipolar illness (also called manic-depressive illness) or suicidal thoughts or actions.
  3. How can I watch for and try to prevent suicidal thoughts and actions in myself or a family member?
    • Pay close attention to any changes, especially sudden changes, in mood, behaviors, thoughts, or feelings. This is very important when an antidepressant medicine is started or when the dose is changed.
    • Call the healthcare provider right away to report new or sudden changes in mood, behavior, thoughts, or feelings.
    • Keep all follow-up visits with the healthcare provider as scheduled. Call the healthcare provider between visits as needed, especially if you have concerns about symptoms.

Call a healthcare provider right away if you or your family member has any of the following symptoms, especially if they are new, worse, or worry you:

  • Thoughts about suicide or dying
  • Attempts to commit suicide
  • New or worse depression
  • New or worse anxiety
  • Feeling very agitated or restless
  • Panic attacks
  • Trouble sleeping (insomnia)
  • New or worse irritability
  • Acting aggressive, being angry, or violent
  • Acting on dangerous impulses
  • An extreme increase in activity and talking (mania)
  • Other unusual changes in behavior or mood

What else do I need to know about antidepressant medicines?

  • Never stop an antidepressant medicine without first talking to a healthcare provider.
    Stopping an antidepressant medicine suddenly can cause other symptoms.
  • Antidepressants are medicines used to treat depression and other illnesses. It is important to discuss all the risks of treating depression and also the risks of not treating it. Patients and their families or other caregivers should discuss all treatment choices with the healthcare provider, not just the use of antidepressants.
  • Antidepressant medicines have other side effects. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
  • Antidepressant medicines can interact with other medicines. Know all of the medicines that you or your family member takes. Keep a list of all medicines to show the healthcare provider. Do not start new medicines without first checking with your healthcare provider.
  • Not all antidepressant medicines prescribed for children are FDA approved for use in children. Talk to your child's healthcare provider for more information.

This Medication Guide has been approved by the U.S. Food and Drug Administration for all antidepressants.

Last reviewed on RxList: 6/11/2010
This monograph has been modified to include the generic and brand name in many instances.

Disclaimer

Parnate Consumer

IMPORTANT: HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.

TRANYLCYPROMINE - ORAL

(tran-il-SIP-roe-meen)

COMMON BRAND NAME(S): Parnate

WARNING: Antidepressant medications are used to treat a variety of conditions, including depression and other mental/mood disorders. These medications can help prevent suicidal thoughts/attempts and provide other important benefits. However, studies have shown that a small number of people (especially people younger than 25) who take antidepressants for any condition may experience worsening depression, other mental/mood symptoms, or suicidal thoughts/attempts. Therefore, it is very important to talk with the doctor about the risks and benefits of antidepressant medication (especially for people younger than 25), even if treatment is not for a mental/mood condition.

Tell the doctor immediately if you notice worsening depression/other psychiatric conditions, unusual behavior changes (including possible suicidal thoughts/attempts), or other mental/mood changes (including new/worsening anxiety, panic attacks, trouble sleeping, irritability, hostile/angry feelings, impulsive actions, severe restlessness, very rapid speech). Be especially watchful for these symptoms when a new antidepressant is started or when the dose is changed.

USES: Tranylcypromine is an antidepressant (monoamine oxidase inhibitor). This medication treats depression by restoring the balance of certain natural substances (neurotransmitters) in the brain. Tranylcypromine can improve your mood and feelings of well-being. Usually, this medication is used in persons who have not responded to treatment with other drugs.

HOW TO USE: Read the Medication Guide available from your pharmacist before you start using tranylcypromine and each time you get a refill. If you have any questions, consult your doctor or pharmacist.

Take this medication by mouth, usually in divided doses or as directed by your doctor. This medication may be taken with or without food. Dosage is based on your medical condition and response to therapy and usually will not be more than 60 milligrams per day.

To reduce your risk of side effects, your doctor may start you at a low dose and gradually increase your dose. Once your condition improves and you are better for a while, your doctor may work with you to reduce your regular dose. Follow your doctor's instructions carefully. Do not take more or less medication or take it more frequently than prescribed. Your condition will not improve any faster and your risk of side effects will increase.

Use this medication regularly in order to get the most benefit from it. To help you remember, use it at the same time(s) each day. It may take several weeks for the full benefits of this medication to be noticed. Do not stop taking this medication without consulting your doctor.

This medication may cause withdrawal reactions, especially if it has been used regularly for a long time or in high doses. In such cases, withdrawal symptoms (such as restlessness, confusion, hallucinations, headache, weakness, and diarrhea) may occur if you suddenly stop using this medication. To prevent withdrawal reactions, your doctor may reduce your dose gradually. Consult your doctor or pharmacist for more details, and report any withdrawal reactions immediately.

Inform your doctor if your condition persists or worsens.

Disclaimer

Parnate Consumer (continued)

SIDE EFFECTS: See also Warning section.

Dizziness, drowsiness, tiredness, weakness, problems sleeping, constipation, and dry mouth may occur. If any of these effects persist or worsen, notify your doctor or pharmacist promptly.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor immediately if any of these unlikely but serious side effects occur: fainting, mental/mood changes (e.g., agitation, confusion), muscle stiffness/twitching, changes in sexual ability/interest, shaking (tremor), shivering, swollen ankles/legs, unusual weight gain, vision changes (e.g., double/blurred vision).

Tell your doctor immediately if any of these highly unlikely but very serious side effects occur: severe stomach/abdominal pain, persistent nausea/vomiting, seizures, dark urine, yellowing eyes/skin.

This drug may rarely cause an attack of extremely high blood pressure (hypertensive crisis), which may be fatal. Many drug and food interactions can increase this risk (See also Drug Interaction section.) Stop taking tranylcypromine and seek immediate medical attention if any of these serious side effects occur: frequent/severe headache, fast/slow/irregular/pounding heartbeat, chest pain, neck stiffness/soreness, severe nausea/vomiting, sweating/clammy skin (sometimes with fever), widened pupils, sudden sensitivity to light (photophobia).

A serious allergic reaction to this drug is unlikely, but seek immediate medical attention if it occurs. Symptoms of a serious allergic reaction include: rash, itching/swelling (especially of the face/tongue/throat), dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Read the Parnate (tranylcypromine) Side Effects Center for a complete guide to possible side effects »

PRECAUTIONS: Before taking tranylcypromine, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

This medication should not be used if you have certain medical conditions. Before using this medicine, consult your doctor or pharmacist if you have: a certain kind of adrenal gland tumor (pheochromocytoma), cerebrovascular disease (e.g., stroke), heart problems (e.g., congestive heart failure, heart attack), high blood pressure, history of severe/frequent headaches, liver problems.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: personal/family history of mental/mood disorders (e.g., schizophrenia, bipolar disorder), family history of high blood pressure, heart disease (e.g., coronary artery disease, history of chest pain), kidney disease, certain nervous system diseases (Parkinson's syndrome, seizures), overactive thyroid (hyperthyroidism).

This drug may make you dizzy or drowsy. Do not drive, use machinery, or do any activity that requires alertness until you are sure you can perform such activities safely. Avoid alcoholic beverages.

To minimize dizziness and the risk of fainting, get up slowly when rising from a sitting or lying position.

Before having surgery or any procedures requiring use of contrast dye (e.g., myelography), tell your doctor or dentist you are on this medication. You may need to stop taking this drug beforehand. Follow your doctor's instructions carefully.

If you have heart disease, this medication may mask chest pain. Avoid strenuous exercise while taking this medication.

If you have diabetes, tranylcypromine may lower your blood sugar levels. Check your blood sugar regularly, and share the results with your doctor. Tell your doctor immediately if you have symptoms of low blood sugar such as cold sweat, shaking, rapid heart rate, fainting, and hunger. Your anti-diabetic medication or diet may need to be adjusted.

Caution is advised when using this drug in the elderly because they may be more sensitive to the effects of the drug, especially the effects on blood pressure.

This medication should be used only when clearly needed during pregnancy. Discuss the risks and benefits with your doctor.

This medication passes into breast milk. Consult your doctor before breast-feeding.

Disclaimer

Parnate Consumer (continued)

DRUG INTERACTIONS: Your healthcare professionals (e.g., doctor or pharmacist) may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop or change the dosage of any medicine before checking with them first.

This drug should not be used with the following medications because very serious (possibly fatal) interactions may occur: other antidepressants (e.g., nefazodone, TCAs such as amitriptyline/nortriptyline, SNRIs such as venlafaxine, SSRIs such as citalopram/fluoxetine/paroxetine), appetite suppressants (e.g., diethylpropion, sibutramine), drugs for attention deficit disorder (e.g., atomoxetine, methylphenidate), certain antihistamines (azatadine, carbetapentane, chlorpheniramine), bupropion, buspirone, carbamazepine, cyclobenzaprine, dextromethorphan, certain drugs for glaucoma (e.g., apraclonidine, brimonidine), certain drugs for high blood pressure (e.g., guanethidine, methyldopa), other MAO inhibitors (isocarboxazid, linezolid, methylene blue, moclobemide, phenelzine, procarbazine, rasagiline, selegiline), certain narcotic medications (e.g., fentanyl, meperidine), certain drugs for Parkinson's (e.g., entacapone, levodopa, tolcapone), street drugs (e.g., MDMA/"ecstasy", LSD, mescaline), stimulants (e.g., amphetamines, cocaine, dopamine, epinephrine, phenylalanine), tetrabenazine, "triptan" migraine drugs (e.g., sumatriptan, rizatriptan), tramadol, tyrosine, tryptophan.

If you are currently using any of these medications listed above, tell your doctor or pharmacist before starting tranylcypromine. Do not take these medications within the 2 weeks before, during or after treatment with tranylcypromine. If you have been taking fluoxetine, wait at least 5 weeks after stopping fluoxetine before starting tranylcypromine. Discuss with your doctor how much time to wait between starting or stopping any of these drugs and taking tranylcypromine.

Before using this medication, tell your doctor or pharmacist of all prescription and nonprescription/herbal products you may use, especially of: drugs for high blood pressure (e.g., beta blockers such as atenolol, clonidine, rauwolfia alkaloids such as reserpine, "water pills"/diuretics such as hydrochlorothiazide).

Also report the use of drugs which might increase seizure risk (decrease seizure threshold) when combined with tranylcypromine such as isoniazid (INH), phenothiazines (e.g., thioridazine), theophylline, or tricyclic antidepressants (e.g., imipramine), among others. Consult your doctor or pharmacist for details.

Tell your doctor or pharmacist if you also take drugs that cause drowsiness such as: certain antihistamines (e.g., diphenhydramine), anti-seizure drugs (e.g., phenytoin), medicine for sleep or anxiety (e.g., alprazolam, diazepam, zolpidem), muscle relaxants, narcotic pain relievers (e.g., codeine), psychiatric medicines (e.g., chlorpromazine, lithium, risperidone, trazodone).

Check the labels on all your medicines (e.g., allergy, cough-and-cold products, diet pills) because they may contain dextromethorphan, decongestants, stimulants, or drowsiness-causing ingredients. Ask your pharmacist about the safe use of those products.

It is very important that you follow special dietary restrictions in order to limit the amount of tyramine in your diet. Avoid drinking large amounts of beverages containing caffeine (coffee, tea, colas) or eating large amounts of chocolate. Caffeine can increase the side effects of this medication. Foods and beverages high in tyramine should be avoided while you are taking this medication and for at least 2 weeks after you stop using this medication.

Foods high in tyramine include: aged cheeses (cheddar, camembert, emmenthaler, brie, stilton blue, gruyere, gouda, brick, bleu, roquefort, boursault, parmesan, romano, provolone, liederdranz, colby, edam), aged/dried/fermented/salted/smoked/pickled/processed meats and fish (includes bacon, summer sausage, liverwurst, hot dogs, corned beef, pepperoni, salami, bologna, ham, mortadella, pickled or dried herring), banana peel, beef/chicken liver (stored, not fresh), bouillon cubes, commercial gravies, concentrated yeast extracts, fava beans, Italian green beans, broad beans, fermented bean curd, homemade yeast-leavened bread, kim chee (Korean fermented cabbage), orange pulp, overripe or spoiled fruits, packaged soups, red wine, sauerkraut, sherry, snow pea pods, sourdough bread, soy sauce, soybeans, soybean paste/miso, tofu, tap beer and ale, vermouth.

Moderate-to-low tyramine content foods include: alcohol-free beer, avocados, bananas, bottled beer and ale, chocolate and products made with chocolate, coffee, cola, cultured dairy products (e.g. buttermilk, yogurt, sour cream), distilled spirits, eggplant, canned figs, fish roe (caviar), green bean pods, pate, peanuts, port wine, raisins, raspberries, red plums, spinach, tomatoes, white wine.

Tell your doctor or pharmacist immediately if you notice symptoms of high blood pressure such as fast/slow heartbeat, vomiting, sweating, headache, chest pain, sudden vision changes, weakness on one side of the body, or slurred speech.

Contact your healthcare professionals (e.g., doctor, pharmacist, dietician) for more information, including recommendations for your diet.

This document does not contain all possible interactions. Therefore, before using this product, tell your doctor or pharmacist of all the products you use. Keep a list of all your medications with you, and share the list with your doctor and pharmacist.

OVERDOSE: If overdose is suspected, contact your local poison control center or emergency room immediately. US residents can call the US national poison hotline at 1-800-222-1222. Canadian residents should call their local poison control center directly.

NOTES: Do not share this medication with others.

Laboratory and/or medical tests (e.g., blood pressure, liver function) should be performed periodically to monitor your progress or check for side effects. Consult your doctor for more details.

MISSED DOSE: If you miss a dose, take as soon as you remember unless the next scheduled dose is within 2 hours. In that case, skip the missed dose and resume your usual dosing schedule. Do not double the dose to catch up.

STORAGE: Store at room temperature between 59-86 degrees F (15-30 degrees C) away from light and moisture. Do not store in the bathroom. Keep all medicines away from children and pets.

Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company for more details about how to safely discard your product.

MEDICAL ALERT: Your condition can cause complications in a medical emergency. For enrollment information call MedicAlert at 1-800-854-1166 (USA) or 1-800-668-1507 (Canada).

Information last revised May 2012. Copyright(c) 2012 First Databank, Inc.

Parnate Patient Information Including Side Effects

Brand Names: Parnate

Generic Name: tranylcypromine (Pronunciation: TRAN il SIP roe meen)

What is tranylcypromine (Parnate)?

Tranylcypromine is a monoamine oxidase inhibitor (MAOI) that works by increasing the levels of certain chemicals in the brain.

Tranylcypromine is used to treat major depressive episode in adults. This medication is usually given after other anti-depressants have been tried without successful treatment of symptoms. Tranylcypromine will not treat bipolar disorder (manic depression).

Tranylcypromine may also be used for purposes not listed in this medication guide.

Parnate 10 mg

round, red, imprinted with PARNATE 58

What are the possible side effects of tranylcypromine (Parnate)?

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

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.

Stop using tranylcypromine and call your doctor at once if you have any of these serious side effects:

  • frequent headaches, vision problems, sensitivity to light;
  • fast or pounding heart beats, tight feeling in your chest or throat;
  • swelling of your ankles or feet;
  • pale skin, easy bruising or bleeding, unusual weakness;
  • nausea, vomiting, dizziness, sweating, stiffness in your neck;
  • confusion, lack of coordination, feeling light-headed, fainting; or
  • tremors, muscle twitches you cannot control.

Less serious side effects may include:

  • feeling restless, weak, or drowsy;
  • nausea, diarrhea or constipation, loss of appetite, stomach pain;
  • chills, numbness or tingly feeling;
  • dry mouth, decreased urination;
  • blurred vision, ringing in your ears; or
  • impotence, difficulty having an orgasm.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Read the Parnate (tranylcypromine) Side Effects Center for a complete guide to possible side effects »

What is the most important information I should know about tranylcypromine (Parnate)?

You may have thoughts about suicide when you first start taking an antidepressant, especially if you are younger than 24 years old. Your doctor will need to check you at regular visits for at least the first 12 weeks of treatment.

Call your doctor at once if you have any new or worsening symptoms 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.

While you are taking tranylcypromine, you must not drink alcohol or eat foods that are high in tyramine, listed in the "What should I avoid while taking tranylcypromine?" section of this leaflet. Eating tyramine while you are taking tranylcypromine can raise your blood pressure to dangerous levels, causing life-threatening symptoms such as sudden and severe headache, confusion, blurred vision, problems with speech or balance, nausea, vomiting, chest pain, seizure (convulsions), and sudden numbness or weakness (especially on one side of the body). Call your doctor at once if you have any of these symptoms.

Tranylcypromine may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be alert.

Side Effects Centers

Parnate Patient Information including How Should I Take

What should I discuss with my healthcare provider before taking tranylcypromine (Parnate)?

Do not use this medication if you have used another MAOI such as furazolidone (Furoxone), isocarboxazid (Marplan), phenelzine (Nardil), rasagiline (Azilect), selegiline (Eldepryl, Emsam) within the past 14 days. Serious, life-threatening side effects can occur if you take tranylcypromine before another MAOI has cleared from your body. If you are switching to tranylcypromine from another MAOI, your doctor may start you at a low dose.

There are many other medicines that can cause serious medical problems if you take them together with tranylcypromine. The following drugs should not be used while you are taking tranylcypromine:

  • an antidepressant;
  • blood pressure medicine such as guanethidine (Ismelin), methyldopa (Aldomet), and reserpine;
  • diet pills, stimulants, ADHD medications, over-the-counter cough and cold or allergy medicines;
  • doxepin (Adapin, Sinequan);
  • carbamazepine (Carbatrol, Tegretol);
  • cyclobenzaprine (Flexeril);
  • maprotiline (Ludiomil);
  • procarbazine (Matulane);
  • bupropion (Wellbutrin, Zyban);
  • venlafaxine (Effexor);
  • buspirone (BuSpar);
  • tryptophan (also called L-tryptophan);
  • levodopa (Larodopa, Parcopa, Sinemet); or
  • meperidine (Demerol, Mepergan).

To make sure you can safely take tranylcypromine, tell your doctor if you have any of these other conditions:

  • heart disease, high blood pressure, circulation problems, or a history of stroke;
  • a history of headaches (migraine, cluster, or other types);
  • diabetes; or
  • a seizure disorder such as epilepsy.

You may have thoughts about suicide while taking an antidepressant, especially if you are younger than 24 years old. Tell your doctor if you have worsening depression or suicidal thoughts during the first several weeks of treatment, or whenever your dose is changed.

Your family or other caregivers should also be alert to changes in your mood or symptoms. Your doctor will need to check you at regular visits for at least the first 12 weeks of treatment.

Tranylcypromine may be habit forming and should be used only by the person it was prescribed for. Never share tranylcypromine with another person, especially someone with a history of drug abuse or addiction. Keep the medication in a place where others cannot get to it.

It is not known whether tranylcypromine will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant while using this medication.

Tranylcypromine can pass into breast milk and may harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby.

Do not give this medicine to a child younger than 18 years old without medical advice.

Older adults may be more likely to have side effects from tranylcypromine.

How should I take tranylcypromine (Parnate)?

Take exactly as prescribed by your doctor. Do not take in larger or smaller amounts or for longer than recommended. Follow the directions on your prescription label.

Your doctor may occasionally change your dose to make sure you get the best results.

Your blood pressure will need to be tested often. Visit your doctor regularly.

You may need to stop using the medicine for a short time if you need to have any type of surgery, or if you will have an x-ray, CT scan, or MRI of your spinal cord. Tell any doctor who treats you that you are taking tranylcypromine.

It may take 4 weeks or longer before your symptoms improve. Keep using the medication as directed and tell your doctor if your symptoms do not improve after 4 weeks of treatment.

Do not stop using tranylcypromine suddenly, or you could have unpleasant withdrawal symptoms. Ask your doctor how to avoid withdrawal symptoms when you stop using tranylcypromine. You may need to use less and less before you stop the medication completely.

Store at room temperature away from moisture and heat.

Side Effects Centers

Parnate Patient Information including If I Miss a Dose

What happens if I miss a dose (Parnate)?

Take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.

What happens if I overdose (Parnate)?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222. Overdose symptoms may include feeling restless or anxious, sleep problems (insomnia), agitation, confusion, weakness, severe headache, neck pain or stiffness, fast or pounding heart beats, chest pain, cold sweats, feeling light-headed, or fainting.

What should I avoid while taking tranylcypromine (Parnate)?

While you are taking tranylcypromine, you must not eat foods that are high in tyramine, including:

  • avocados, bananas, figs, raisins, and sauerkraut;
  • beef or chicken liver, fish, meats prepared with tenderizer, bologna, pepperoni, salami, summer sausage, game meat, meat extracts, caviar, dried fish, herring, and shrimp paste;
  • beer (alcoholic and nonalcoholic), red wine (especially Chianti), sherry, vermouth, and other distilled spirits;
  • caffeine (including coffee, tea, cola); and
  • cheeses, including American, blue, boursault, brick, brie, camembert, cheddar, emmenthaler, gruyere, mozzarella, parmesan, romano, roquefort, stilton, and Swiss;
  • chocolate;
  • ginseng;
  • sour cream and yogurt;
  • soy sauce, miso soup, bean curd, fava beans; or
  • yeast extracts.

Eating tyramine while you are taking tranylcypromine can raise your blood pressure to dangerous levels, causing life-threatening side effects.

Drinking alcohol can increase certain side effects of tranylcypromine.

Tranylcypromine may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be alert.

What other drugs will affect tranylcypromine (Parnate)?

Where can I get more information?

Your pharmacist can provide more information about tranylcypromine.


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.

Every effort has been made to ensure that the information provided by Cerner Multum, Inc. ('Multum') is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Multum's drug information does not endorse drugs, diagnose patients or recommend therapy. Multum's drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

Copyright 1996-2012 Cerner Multum, Inc. Version: 5.01. Revision date: 3/28/2011.

Your use of the content provided in this service indicates that you have read,understood and agree to the End-User License Agreement,which can be accessed by clicking on this link.

Healthwise

Side Effects Centers

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