نوراتریپتیلین
Nortriptyline HCl (Pamelor)
نوراتریپتیلین

نام ژنریک

Nortriptyline HCl

شکل دارویی

اشكال دارويي:


Tablet: 10, 25mg

موارد مصرف

موارد و مقدار مصرف


الف) افسردگي، بيماري پانيک.


بزرگسالان: از راه خوراکي مقدار 25 ميلي گرم 4-3 بار در روز مصرف مي‌ شود و به تدريج تا حداکثر mg/kg 150 افزايش مي‌ يابد. به جاي آن ، مي‌ توان مقدار تام مصرف روزانه را به هنگام خواب مصرف کرد.


بيماران مسن يا نوجوانان: مقدار 50-30 ميلي گرم از راه خوراکي و در دوزهاي منقسم مصرف مي‌ شود.


ب) ترک سيگار.


بزرگسالان: روزانه mg 25 از راه خوراکي مصرف مي‌ شود که مي‌ توان ميزان مصرف را به صورت تدريجي تا mg 100-75 در روز افزايش داد. دارو را بايد 28-10 روز قبل از تاريخ شروع ترک آغاز نمود.

موارد منع مصرف

موارد منع مصرف و احتياط


موارد منع مصرف: حساسيت مفرط شناخته شده نسبت به داروهاي ضدافسردگي سه حلقه‌اي و ترکيبات وابسته به آنها، مرحله حاد بهبود انفارکتوس ميوکارد (MI) (ممکن است موجب آريتمي، کاهش عملکرد قلبي شود)، اغما يا کاهش شديد فعاليت تنفسي (به دليل کاهش فعاليت CNS)، همزمان با مصرف داروهاي مهارکننده مونوآمين اکسيداز يا طي 14 روز پس از خاتمه درمان با اين داروها (ممکن است موجب تحريک بيش از حد سمپاتيک، همراه با بحران هايپرتانسيون، هايپرترمي و حملات تشنجي شود ).


موارد احتياط: بيماري‌هاي ديگر قلبي (آريتمي، نارسايي احتقاني قلب ، آنژين صدري، بيماري دريچه‌هاي قلب با بلوک قلبي)، اختلالات تنفسي، الکلسيم، صرع، و اختلالات تشنجي ديگر (ممکن است آستانه تشنج را کاهش دهد)، الکتروشوک درماني (به دليل افزايش خطر هيپومانيا و دليريوم)، بيماري دوقطبي، گلوکوم (حتي مقادير معمول اين دارو ممکن است فشار داخل چشم را افزايش دهد)، پرکاري تيروئيد، يا مصرف هورمونهاي تيروئيدي، ديابت نوع I و II، هيپرتروفي پروستات ، انسداد فلجي روده يا احتباس ادرار (ممکن است موجب بدتر شدن اين حالات شود)، اختلال عملکرد کبد با کليه (اختلال در متابوليسم و دفع دارو ممکن است موجب تجمع آن شود)، بيماري پارکينسون، مصرف همزمان داروهاي بيهوش کننده عمومي.


ضدافسردگي ها منجر به افزايش خطر خودکشي در کودکان ، نوجوانان و جوانان (24-18 سال) مبتلا به افسردگي مي‌ شوند (در اين افراد با احتياط مصرف شود)، بيماران مبتلا به ديابت، نارسايي کبدي و کليوي.

عوارض جانبی دارو

عوارض جانبي


اعصاب مرکزي : کابوس شبانه، پاراستزي، حمله مغزي، خواب آلودگي، سرگيجه، ترمور، ضعف، سردرد، عصبانيت، حملات تشنجي، نوروپاتي محيطي، علائم اکستراپيراميدال، اضطراب، گيجي (بيشتر در سالمندان مشهود است)، تغييرات EEG، توهم، بي خوابي.


قلبي ـ عروقي: افت فشار خون در حالت ايستاده، تاکيکاردي، آريتمي، انفارکتوس ميوکارد (MI)، سکته مغزي، بلوک قلبي، نارسايي احتقاني قلب (CHF)، طپش قلب ، هايپرتانسيون، تغييرات EKG.


پوست: بثورات پوستي، کهير، تب دارويي، راش.


چشم، گوش: تاري ديد، وزوز گوش، گشاد شدن مردمک چشم، افزايش فشار داخل چشمي.


دستگاه گوارش: خشکي دهان ، يبوست، تهوع، استفراغ، بي اشتهايي، اسهال، انسداد فلجي روده.


ادراري ـ تناسلي: احتباس ادرار.


ساير عوارض: تعريق، حساسيت به نور، حساسيت مفرط (بثورات پوستي، کهير، تب دارويي، ادم)، آگرانولوسيتوز، سرکوب مغز استخوان، ترومبوسيتوپني، ائوزينوفيلي، کاهش يا افزايش وزن.


بعد از قطع ناگهاني مصرف طولاني مدت دارو ، ممکن است تهوع، سردرد و بي حالي بروز کند (بروز اين عوارض نشان دهنده اعتياد نمي‌ باشد).


توجه: در صورت بروز علائم حساسيت مفرط، بايد مصرف دارو قطع شود (ولي نه به طور ناگهاني).


بيمار بايد از نظر بروز احتباس ادرار، خشکي شديد دهان، بثورات پوستي، حملات تشنجي، تاکيکاردي، گلودرد، تب يا يرقان تحت مراقبت باشد.


مسموميت و درمان


تظاهرات باليني: 12 ساعت اول بعد از مصرف حاد دارو ، مرحله تحريکي بوده كه با فعاليت بيش از حد آنتي کولينرژيک مشخص مي‌ شود (آشفتگي، تحريک، گيجي، احتباس ادرار، خشک شدن غشاهاي مخاطي، گشاد شدن مردمک چشم، يبوست و انسداد فلجي روده ). به دنبال آن اثرات تضعيف CNS بروز مي‌ كند. از جمله هايپوترمي، کاهش رفلكس‌ها يا فقدان آنها، رخوت، افت فشار خون، سيانوز و آريتمي (شامل تاکيکاردي، اختلال در انتقال جريان الکتريکي قلب و اثرات شبه کينيدين بر روي EKG).


شدت مسموميت را مي‌ توان از روي طولان ي شدن کمپلکس QRS به بيش از ms 100 تخمين زد که معمولاً نشان دهنده غلظت سرمي بيش از mg/ml 1000 است. اسيدوز متابوليک ممکن است به دنبال افت فشار خون، کاهش تهويه تنفسي و تشنجات بروز کند.


درمان: علامتي و حمايتي، از جمله باز نگهداشتن راه تنفسي، ثابت نگهداشتن درجه حرارت بدن و حفظ تعادل مايعات و الکتروليتها است. در صورت هوشيار بودن بيمار، مي‌ توان با تجويز شربت اپيکا ايجاد استفراغ کرد. به دنبال آن با شستشوي معده و تجويز ذغال فعال ، مي‌ توان از جذب بيشتر دارو جلوگيري کرد. دياليز معمولاً بي اثر است. حملات تشنجي را مي‌ توان با تجويز ديازپام يا فني توئين تزريقي، آريتمي را با تجويز فني توئين يا ليدوکائين تزريقي، و اسيدوز را با تجويز بيکربنات سديم درمان کرد. بايد از تجويز باربيتوراتها خودداري شود ، زيرا ممکن است اثرات تضيعف تنفسي و CNS را افزايش دهند.

موارد قابل توجه

-

تداخل دارویی

تداخل دارويي


مصرف همزمان با داروهاي سمپاتوميمت يک از جمله نوراپي نفر ين، فنيل افرين، فنيل پروپانول آمين و افدرين، ممکن است موجب افزايش فشار خون شود.


مصرف همزمان با وارفارين ممکن است زمان پروترومبين را افزايش داده و موجب خونريزي شود.


مصرف همزمان با داروهاي ضدآريتمي (کينيدين، ديزوپيراميد، پروکائين آميد) ممکن است خطر بروز آريتمي‌هاي قلبي و ايجاد اختلال در انتقال جريان الکتريکي قلب را افزايش دهد.


ممکن است اثرات کاهنده فشار خون داروهايي که از طريق مرکزي عمل مي‌ کنند (مانند گوانتيدين، کلونيدين، متيل دوپا و رزرپين) را کاهش دهد.


با مصرف همزمان نورتريپتيلين با داروهاي تضعيف كننده CNS، از جمله فرآورده‌هاي حاوي الکل ، داروهاي ضددرد ، باربيتورات‌ها، داروهاي مخدر ، آرام بخش و بيهوش کننده، آتروپين و داروهاي آنتي کولينرژيک ديگر، از جمله فنوتيازينها، داروهاي آنتي هيستامين، مپريدين و داروهاي ضد پارکينسون (احتمال بروز انسداد فلجي روده ، تغييرات بينايي و يبوست شديد) احتمال تشديد اثرات وجود دارد.


مصرف باربيتوراتها و استعمال دخانيات موجب القاي متابوليسم نورتريپتيلين و کاهش اثر درماني آن مي‌ شود.


فنوتيازينها و هالوپريدول متابوليسم نورتريپتيلين را کاهش مي‌ دهند و از اثربخشي آن مي‌ کاهند.


متيل فنيدات، سايمتيدين، داروهاي خوراکي جلوگيري کننده از بارداري و داروهاي مهارکننده گيرنده‌هاي بتا ممکن است متابوليسم نورتريپتيلين را مهار کرده و غلظت پلاسمايي دارو و احتمال مسموميت را افزايش دهند.

مکانیزم اثر

تداخل دارويي


مصرف همزمان با داروهاي سمپاتوميمت يک از جمله نوراپي نفر ين، فنيل افرين، فنيل پروپانول آمين و افدرين، ممکن است موجب افزايش فشار خون شود.


مصرف همزمان با وارفارين ممکن است زمان پروترومبين را افزايش داده و موجب خونريزي شود.


مصرف همزمان با داروهاي ضدآريتمي (کينيدين، ديزوپيراميد، پروکائين آميد) ممکن است خطر بروز آريتمي‌هاي قلبي و ايجاد اختلال در انتقال جريان الکتريکي قلب را افزايش دهد.


ممکن است اثرات کاهنده فشار خون داروهايي که از طريق مرکزي عمل مي‌ کنند (مانند گوانتيدين، کلونيدين، متيل دوپا و رزرپين) را کاهش دهد.


با مصرف همزمان نورتريپتيلين با داروهاي تضعيف كننده CNS، از جمله فرآورده‌هاي حاوي الکل ، داروهاي ضددرد ، باربيتورات‌ها، داروهاي مخدر ، آرام بخش و بيهوش کننده، آتروپين و داروهاي آنتي کولينرژيک ديگر، از جمله فنوتيازينها، داروهاي آنتي هيستامين، مپريدين و داروهاي ضد پارکينسون (احتمال بروز انسداد فلجي روده ، تغييرات بينايي و يبوست شديد) احتمال تشديد اثرات وجود دارد.


مصرف باربيتوراتها و استعمال دخانيات موجب القاي متابوليسم نورتريپتيلين و کاهش اثر درماني آن مي‌ شود.


فنوتيازينها و هالوپريدول متابوليسم نورتريپتيلين را کاهش مي‌ دهند و از اثربخشي آن مي‌ کاهند.


متيل فنيدات، سايمتيدين، داروهاي خوراکي جلوگيري کننده از بارداري و داروهاي مهارکننده گيرنده‌هاي بتا ممکن است متابوليسم نورتريپتيلين را مهار کرده و غلظت پلاسمايي دارو و احتمال مسموميت را افزايش دهند.

فارماكوكینتیك

فارماكوكينتيك


جذب: بعد از مصرف خوراکي به سرعت از دستگاه گوارش جذب مي‌ شود.


پخش: به طور گسترده در داخل بدن، از جمله CNS و شير، انتشار مي‌ يابد. تا حدود 95 درصد به پروتئين پيوند مي‌ يابد. حداکثر غلظت پلاسمايي آن طي هشت ساعت بعد از مصرف حاصل مي‌ شود. غلظت پايدار سرمي طي 4-2 هفته حاصل مي‌ گردد. غلظت سرمي درماني اين دارو بين ng/ml 150-50 است.


متابوليسم: در کبد متابوليزه مي‌ شود. متفاوت بودن غلظت‌هاي سرمي اين دارو در افراد مختلفي که يک مقدار مشابه از دارو مصرف کرده‌اند، ممکن است به دليل قابل توجه بودن اثر اولين عبور از کبد باشد.


دفع: بيشترين مقدار مصرفي اين دارو از طريق ادرار و مقدار ي از آن نيز از طريق مجاري صفراو ي در مدفوع دفع مي‌ شود.

سایر اطلاعات

طبقه‌بندي فارماكولوژيك: ضدافسردگي سه حلقه ا ي.


طبقه‌بندي درماني: ضدافسردگي.


طبقه‌بندي مصرف در بارداري: رده D


نکات قابل توصيه به بيمار


ممکن است براي شروع اثرات کامل درماني اين دارو تا چهار هفته زمان لازم باشد.


اين دارو داراي اثرات آرام بخشي است.


براي جلوگيري از بي حالي در طول روز ، مي‌ توانيد تمام مقدار مصرف روزانه دارو را به هنگام خواب مصرف کنيد.


از مصرف فرآورده‌هاي حاوي الکل خوددار ي کنيد. همچنين، از دو برابر کردن مقدار مصرف، بعد از فراموش کردن يک نوبت مصرف دارو، خودداري نماييد. مصرف دارو را به طور ناگهاني قطع نکنيد، مگر آنکه پزشک دستور داده باشد.


احتمال بروز سرگيجه وجود دارد. در شروع درمان، براي جلوگيري از بروز سرگيجه، بعد از هر بار مصرف دارو به مدت 30 دقيقه
دراز بکشيد و از تغيير ناگهاني وضعيت خودداري کنيد. شدت افت فشار خون وضعيتي با مصرف نورتريپتيلين کمتر از مصرف آمي تريپتيلين است.


در صورت بروز واکنش‌هاي غيرطبيعي، مانند گيجي، اختلالات حرکتي، سنكوپ، تاكيكاردي يا اشکال در دفع ادرار، فوراً به پزشک اطلاع دهيد.


مصرف در سالمندان: در اين بيماران ممکن است کاهش مقدار مصرف لازم باشد. خطر بروز عوارض قلبي دارو در سالمندان بيشتر است. احتمال افت فشار خون با نورتريپتيلين کمتر از ساير ضدافسردگي‌هاي سه حلقه‌اي است.


مصرف در كودكان: مصرف اين دارو در کودکان توصيه نمي‌ شود. براي نوجوانان ممکن است کاهش مقدار مصرف لازم باشد.


مصرف در شيردهي: اين دارو با غلظت‌هاي کم در شير ترشح مي‌ شود. منافع دارو در مقابل مضرات آن بايد سنجيده شود.


ملاحظات اختصاصي


علاوه بر ملاحظات مربوط به تمامي داروهاي ضدافسردگي سه حلقه‌ اي، رعايت موارد زير نيز توصيه مي‌ شود:


براي کاهش بي حالي در طي روز ، مي‌ توان نورتريپتيلين را به هنگام خواب مصرف کرد. ايجاد تحمل نسبت به اثرات آرام بخشي دارو معمولاً طي هفته ‌هاي اول درمان ظاهر مي‌ شود.


مصرف دارو بايد به صورت تدريجي و طي چند هفته قطع شود. مصرف اين دارو بايد حداقل 48 ساعت قبل از هر گونه اعمال جراحي قطع گردد .


اثر بر آزمايشهاي تشخيصي


نورتريپتيلين ممکن است زمان لازم براي انتقال جريان الکتريکي قلب را طولاني سازد (طولاني شدن فاصله ‌هاي QT و PR و پهن شدن موج T بر رو ي الکتروکارد يوگرام). همچنين، اين دارو ممکن است نتايج تستهاي عملکرد کبد را افزايش دهد، تعداد گلبول‌هاي سفيد خون را کاهش و غلظت سرمي گلوکز را کاهش يا افزايش دهد.

Nortriptyline HCl (Pamelor)

Pamelor™
(nortriptyline HCl) Capsules USP (nortriptyline HCl) and Oral Solution USP

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 nortriptyline hydrochloride 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. Nortriptyline hydrochloride is not approved for use in pediatric patients (see WARNINGS, Clinical Worsening and Suicide Risk; PATIENT INFORMATION; and PRECAUTIONS, Pediatric Use).

DRUG DESCRIPTION

Pamelor™ (nortriptyline HCl) is 1-propanamine, 3-(10,11-dihydro-5Hdibenzo[a,d]cyclohepten-5-ylidene)-N-methyl-, hydrochloride.

The structural formula is as follows:

Pamelor™ (nortriptyline HCl)  Structural Formula Illustration

C19H21N HCl        MW = 299.84

10 mg, 25 mg, 50 mg, and 75 mg Capsules

Active Ingredient: nortriptyline hydrochloride USP.

10 mg, 25 mg, and 75 mg Capsules

Inactive Ingredients: D&C Yellow #10, FD&C Yellow #6, gelatin, silicone fluid, starch, and titanium dioxide.

50 mg Capsules

Inactive Ingredients: gelatin, silicone fluid, starch, and titanium dioxide.

Solution

Active Ingredient: nortriptyline hydrochloride USP.

Inactive Ingredients: alcohol, benzoic acid, flavoring, purified water, and sorbitol.

What are the possible side effects of nortriptyline (Pamelor)?

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.

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.

Call your doctor at once if you have any of these serious side effects:

  • fast,...

Read All Potential Side Effects and See Pictures of Pamelor »

Last reviewed on RxList: 11/6/2012
This monograph has been modified to include the generic and brand name in many instances.

INDICATIONS

Pamelor™ (nortriptyline HCl) is indicated for the relief of symptoms of depression. Endogenous depressions are more likely to be alleviated than are other depressive states.

DOSAGE AND ADMINISTRATION

Pamelor is not recommended for children.

Pamelor is administered orally in the form of capsules or liquid. Lower than usual dosages are recommended for elderly patients and adolescents. Lower dosages are also recommended for outpatients than for hospitalized patients who will be under close supervision. The physician should initiate dosage at a low level and increase it gradually, noting carefully the clinical response and any evidence of intolerance. Following remission, maintenance medication may be required for a longer period of time at the lowest dose that will maintain remission.

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

Usual Adult Dose

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

Elderly and Adolescent Patients

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

Switching a Patient To or From a Monoamine Oxidase Inhibitor (MAOI) Intended to Treat Psychiatric Disorders

At least 14 days should elapse between discontinuation of an MAOI intended to treat psychiatric disorders and initiation of therapy with Pamelor. Conversely, at least 14 days should be allowed after stopping Pamelor before starting an MAOI intended to treat psychiatric disorders (see CONTRAINDICATIONS).

Use of Pamelor With Other MAOIs, Such as Linezolid or Methylene Blue

Do not start Pamelor in a patient who is being treated with linezolid or intravenous methylene blue because there is increased risk of serotonin syndrome. In a patient who requires more urgent treatment of a psychiatric condition, other interventions, including hospitalization, should be considered (see CONTRAINDICATIONS).

In some cases, a patient already receiving Pamelor therapy may require urgent treatment with linezolid or intravenous methylene blue. If acceptable alternatives to linezolid or intravenous methylene blue treatment are not available and the potential benefits of linezolid or intravenous methylene blue treatment are judged to outweigh the risks of serotonin syndrome in a particular patient, Pamelor should be stopped promptly, and linezolid or intravenous methylene blue can be administered. The patient should be monitored for symptoms of serotonin syndrome for two weeks or until 24 hours after the last dose of linezolid or intravenous methylene blue, whichever comes first. Therapy with Pamelor may be resumed 24 hours after the last dose of linezolid or intravenous methylene blue (see WARNINGS).

The risk of administering methylene blue by non-intravenous routes (such as oral tablets or by local injection) or in intravenous doses much lower than 1 mg/kg with Pamelor is unclear. The clinician should, nevertheless, be aware of the possibility of emergent symptoms of serotonin syndrome with such use (see WARNINGS).

HOW SUPPLIED

Pamelor™ (nortriptyline HCl) Capsules USP

Pamelor™ (nortriptyline HCl) Capsules USP, equivalent to 10 mg, 25 mg, 50 mg, and 75 mg base, are available as follows:

10 mg: Light orange opaque cap printed PAMELOR 10 mg“ in black and white opaque body printed “M“ in black.

Bottles of 30 ............ NDC 0406-9910-03

25 mg: Light orange opaque cap printed PAMELOR 25 mg“ in black and white opaque body printed “M“ in black.

Bottles of 30 ............ NDC 0406-9911-03

50 mg: White opaque cap printed PAMELOR 50 mg“ in black and white opaque body printed “M“ in black.

Bottles of 30 ............ NDC 0406-9912-03

75 mg: Light orange opaque cap printed PAMELOR 75 mg“ in black and light orange opaque body printed “M“ in black.

Bottles of 30 ............ NDC 0406-9913-03

Store and Dispense

Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].

Dispense in tight container (USP) with a child-resistant closure.

Pamelor™ (nortriptyline HCl) Oral Solution USP

Pamelor™ (nortriptyline HCl) Oral Solution USP, equivalent to 10 mg base per 5 mL, is supplied in 16-fluid-ounce bottles (NDC 0406-9918-16). Alcohol content 4%.

Store and Dispense

Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].

Dispense in tight, light-resistant container.

Capsules manufactured by: Patheon Inc. Whitby, Ontario, Canada L1N 5Z5, Oral Solution manufactured by: Novartis Consumer Health, Inc. Lincoln, Nebraska 68517. Manufactured for: Mallinckrodt Inc. Hazelwood, MO 63042 USA. Rev 10/2012

Last reviewed on RxList: 11/6/2012
This monograph has been modified to include the generic and brand name in many instances.

SIDE EFFECTS

Note

Included in the following list are a few adverse reactions that have not been reported with this specific drug. However, the pharmacologic similarities among the tricyclic antidepressant drugs require that each of the reactions be considered when nortriptyline is administered.

Cardiovascular

Hypotension, hypertension, tachycardia, palpitation, myocardial infarction, arrhythmias, heart block, stroke.

Psychiatric

Confusional states (especially in the elderly) with hallucinations, disorientation, delusions; anxiety, restlessness, agitation; insomnia, panic, nightmares; hypomania; exacerbation of psychosis.

Neurologic

Numbness, tingling, paresthesias of extremities; incoordination, ataxia, tremors; peripheral neuropathy; extrapyramidal symptoms; seizures, alteration in EEG patterns; tinnitus.

Anticholinergic

Dry mouth and, rarely, associated sublingual adenitis; blurred vision, disturbance of accommodation, mydriasis; constipation, paralytic ileus; urinary retention, delayed micturition, dilation of the urinary tract.

Allergic

Skin rash, petechiae, urticaria, itching, photosensitization (avoid excessive exposure to sunlight); edema (general or of face and tongue), drug fever, cross-sensitivity with other tricyclic drugs.

Hematologic

Bone marrow depression, including agranulocytosis; eosinophilia; purpura; thrombocytopenia.

Gastrointestinal

Nausea and vomiting, anorexia, epigastric distress, diarrhea, peculiar taste, stomatitis, abdominal cramps, blacktongue.

Endocrine

Gynecomastia in the male, breast enlargement and galactorrhea in the female; increased or decreased libido, impotence; testicular swelling; elevation or depression of blood sugar levels; syndrome of inappropriate ADH (antidiuretic hormone) secretion.

Other

Jaundice (simulating obstructive), altered liver function; weight gain or loss; perspiration; flushing; urinary frequency, nocturia; drowsiness, dizziness, weakness, fatigue; headache; parotid swelling; alopecia.

Withdrawal Symptoms

Though these are not indicative of addiction, abrupt cessation of treatment after prolonged therapy may produce nausea, headache, and malaise.

Read the Pamelor (nortriptyline hcl) Side Effects Center for a complete guide to possible side effects »

DRUG INTERACTIONS

Administration of reserpine during therapy with a tricyclic antidepressant has been shown to produce a “stimulating“ effect in some depressed patients.

Close supervision and careful adjustment of the dosage are required when Pamelor is used with other anticholinergic drugs and sympathomimetic drugs.

Concurrent administration of cimetidine and tricyclic antidepressants can produce clinically significant increases in the plasma concentrations of the tricyclic antidepressant. The patient should be informed that the response to alcohol may be exaggerated.

A case of significant hypoglycemia has been reported in a type II diabetic patient maintained on chlorpropamide (250 mg/day), after the addition of nortriptyline (125 mg/day).

Drugs Metabolized by P450 2D6

The biochemical activity of the drug metabolizing isozyme cytochrome P450 2D6 (debrisoquin hydroxylase) is reduced in a subset of the Caucasian population (about 7% to 10% of Caucasians are so called “poor metabolizers“); reliable estimates of the prevalence of reduced P450 2D6 isozyme activity among Asian, African and other populations are not yet available. Poor metabolizers have higher than expected plasma concentrations of tricyclic antidepressants (TCAs) when given usual doses. Depending on the fraction of drug metabolized by P450 2D6, the increase in plasma concentration may be small, or quite large (8 fold increase in plasma AUC of the TCA).

In addition, certain drugs inhibit the activity of this isozyme and make normal metabolizers resemble poor metabolizers. An individual who is stable on a given dose of TCA may become abruptly toxic when given one of these inhibiting drugs as concomitant therapy. The drugs that inhibit cytochrome P450 2D6 include some that are not metabolized by the enzyme (quinidine; cimetidine) and many that are substrates for P450 2D6 (many other antidepressants, phenothiazines, and the Type 1C antiarrhythmics propafenone and flecainide). While all the selective serotonin reuptake inhibitors (SSRIs), e.g., fluoxetine, sertraline, and paroxetine, inhibit P450 2D6, they may vary in the extent of inhibition. The extent to which SSRI TCA interactions may pose clinical problems will depend on the degree of inhibition and the pharmacokinetics of the SSRI involved. Nevertheless, caution is indicated in the co-administration of TCAs with any of the SSRIs and also in switching from one class to the other. Of particular importance, sufficient time must elapse before initiating TCA treatment in a patient being withdrawn from fluoxetine, given the long half-life of the parent and active metabolite (at least 5 weeks may be necessary).

Concomitant use of tricyclic antidepressants with drugs that can inhibit cytochrome P450 2D6 may require lower doses than usually prescribed for either the tricyclic antidepressant or the other drug. Furthermore, whenever one of these other drugs is withdrawn from co-therapy, an increased dose of tricyclic antidepressant may be required. It is desirable to monitor TCA plasma levels whenever a TCA is going to be co-administered with another drug known to be an inhibitor of P450 2D6.

Monoamine Oxidase Inhibitors (MAOIs)

(See CONTRAINDICATIONS, WARNINGS, and DOSAGE AND ADMINISTRATION.)

Serotonergic Drugs

(See CONTRAINDICATIONS, WARNINGS, and DOSAGE AND ADMINISTRATION.)

Last reviewed on RxList: 11/6/2012
This monograph has been modified to include the generic and brand name in many instances.

WARNINGS

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 to 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 4400 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 1000 patients treated) are provided in Table 1.

Table 1

Age Range Drug-Placebo Difference in Number of Cases of Suicidality per 1000 Patients Treated
Increases Compared to Placebo
< 18 14 additional cases
18-24 5 additional cases
Decreases Compared to Placebo
25-64
≥ 65 1 fewer case 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 health care providers. Such monitoring should include daily observation by families and caregivers. Prescriptions for nortriptyline hydrochloride should be written for the smallest quantity of capsules 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 nortriptyline hydrochloride is not approved for use in treating bipolar depression.

Patients with cardiovascular disease should be given Pamelor only under close supervision because of the tendency of the drug to produce sinus tachycardia and to prolong the conduction time. Myocardial infarction, arrhythmia, and strokes have occurred. The antihypertensive action of guanethidine and similar agents may be blocked. Because of its anticholinergic activity, Pamelor should be used with great caution in patients who have glaucoma or a history of urinary retention. Patients with a history of seizures should be followed closely when Pamelor is administered, inasmuch as this drug is known to lower the convulsive threshold. Great care is required if Pamelor is given to hyperthyroid patients or to those receiving thyroid medication, since cardiac arrhythmias may develop.

Pamelor may impair the mental and/or physical abilities required for the performance of hazardous tasks, such as operating machinery or driving a car; therefore, the patient should be warned accordingly.

Excessive consumption of alcohol in combination with nortriptyline therapy may have a potentiating effect, which may lead to the danger of increased suicidal attempts or overdosage, especially in patients with histories of emotional disturbances or suicidal ideation.

The concomitant administration of quinidine and nortriptyline may result in a significantly longer plasma half-life, higher AUC, and lower clearance of nortriptyline.

Serotonin Syndrome

The development of a potentially life-threatening serotonin syndrome has been reported with SNRIs and SSRIs, including Pamelor, alone but particularly with concomitant use of other serotonergic drugs (including triptans, tricyclic antidepressants, fentanyl, lithium, tramadol, tryptophan, buspirone, and St. John's Wort) and with drugs that impair metabolism of serotonin (in particular, MAOIs, both those intended to treat psychiatric disorders and also others, such as linezolid and intravenous methylene blue).

Serotonin syndrome symptoms may include mental status changes (e.g., agitation, hallucinations, delirium, and coma), autonomic instability (e.g., tachycardia, labile blood pressure, dizziness, diaphoresis, flushing, hyperthermia), neuromuscular changes (e.g., tremor, rigidity, myoclonus, hyperreflexia, incoordination), seizures, and/or gastrointestinal symptoms (e.g., nausea, vomiting, diarrhea). Patients should be monitored for the emergence of serotonin syndrome.

The concomitant use of Pamelor with MAOIs intended to treat psychiatric disorders is contraindicated. Pamelor should also not be started in a patient who is being treated with MAOIs such as linezolid or intravenous methylene blue. All reports with methylene blue that provided information on the route of administration involved intravenous administration in the dose range of 1 mg/kg to 8 mg/kg. No reports involved the administration of methylene blue by other routes (such as oral tablets or local tissue injection) or at lower doses. There may be circumstances when it is necessary to initiate treatment with an MAOI such as linezolid or intravenous methylene blue in a patient taking Pamelor. Pamelor should be discontinued before initiating treatment with the MAOI (see CONTRAINDICATIONS and DOSAGE AND ADMINISTRATION).

If concomitant use of Pamelor with other serotonergic drugs, including triptans, tricyclic antidepressants, fentanyl, lithium, tramadol, buspirone, tryptophan, and St. John's Wort is clinically warranted, patients should be made aware of a potential increased risk for serotonin syndrome, particularly during treatment initiation and dose increases.

Treatment with Pamelor and any concomitant serotonergic agents should be discontinued immediately if the above events occur and supportive symptomatic treatment should be initiated.

Use in Pregnancy

Safe use of Pamelor during pregnancy and lactation has not been established; therefore, when the drug is administered to pregnant patients, nursing mothers, or women of childbearing potential, the potential benefits must be weighed against the possible hazards. Animal reproduction studies have yielded inconclusive results.

PRECAUTIONS

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 nortriptyline hydrochloride and should counsel them in its appropriate use. A patient Medication Guide about “Antidepressant Medicines, Depression and other Serious Mental Illness, and Suicidal Thoughts or Actions“ is available for nortriptyline hydrochloride. 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 nortriptyline hydrochloride.

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.

The use of Pamelor in schizophrenic patients may result in an exacerbation of the psychosis or may activate latent schizophrenic symptoms. If the drug is given to overactive or agitated patients, increased anxiety and agitation may occur. In manic-depressive patients, Pamelor may cause symptoms of the manic phase to emerge.

Troublesome patient hostility may be aroused by the use of Pamelor. Epileptiform seizures may accompany its administration, as is true of other drugs of its class.

When it is essential, the drug may be administered with electroconvulsive therapy, although the hazards may be increased. Discontinue the drug for several days, if possible, prior to elective surgery.

The possibility of a suicidal attempt by a depressed patient remains after the initiation of treatment; in this regard, it is important that the least possible quantity of drug be dispensed at any given time.

Both elevation and lowering of blood sugar levels have been reported.

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 nortriptyline hydrochloride in a child or adolescent must balance the potential risks with the clinical need.

Geriatric Use

Clinical studies of Pamelor did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Other reported clinical experience indicates that, as with other tricyclic antidepressants, hepatic adverse events (characterized mainly by jaundice and elevated liver enzymes) are observed very rarely in geriatric patients and deaths associated with cholestatic liver damage have been reported in isolated instances. Cardiovascular function, particularly arrhythmias and fluctuations in blood pressure, should be monitored. There have also been reports of confusional states following tricyclic antidepressant administration in the elderly. Higher plasma concentrations of the active nortriptyline metabolite, 10hydroxynortriptyline, have also been reported in elderly patients. As with other tricyclic antidepressants, dose selection for an elderly patient should usually be limited to the smallest effective total daily dose (see DOSAGE AND ADMINISTRATION).

Last reviewed on RxList: 11/6/2012
This monograph has been modified to include the generic and brand name in many instances.

OVERDOSE

Deaths may occur from overdosage with this class of drugs. Multiple drug ingestion (including alcohol) is common in deliberate tricyclic antidepressant overdose. As the management is complex and changing, it is recommended that the physician contact a poison control center for current information on treatment. Signs and symptoms of toxicity develop rapidly after tricyclic antidepressant overdose, therefore, hospital monitoring is required as soon as possible.

Manifestations

Critical manifestations of overdose include: cardiac dysrhythmias, severe hypotension, shock, congestive heart failure, pulmonary edema, convulsions, and CNS depression, including coma. Changes in the electrocardiogram, particularly in QRS axis or width, are clinically significant indicators of tricyclic antidepressant toxicity.

Other signs of overdose may include: confusion, restlessness, disturbed concentration, transient visual hallucinations, dilated pupils, agitation, hyperactive reflexes, stupor, drowsiness, muscle rigidity, vomiting, hypothermia, hyperpyrexia, or any of the acute symptoms listed under ADVERSE REACTIONS. There have been reports of patients recovering from nortriptyline overdoses of up to 525 mg.

Management

General

Obtain an ECG and immediately initiate cardiac monitoring. Protect the patient's airway, establish an intravenous line and initiate gastric decontamination. A minimum of six hours of observation with cardiac monitoring and observation for signs of CNS or respiratory depression, hypotension, cardiac dysrhythmias and/or conduction blocks, and seizures is necessary. If signs of toxicity occur at any time during this period, extended monitoring is required. There are case reports of patients succumbing to fatal dysrhythmias late after overdose; these patients had clinical evidence of significant poisoning prior to death and most received inadequate gastrointestinal decontamination. Monitoring of plasma drug levels should not guide management of the patient.

Gastrointestinal Decontamination

All patients suspected of tricyclic antidepressant overdose should receive gastrointestinal decontamination. This should include large volume gastric lavage followed by activated charcoal. If consciousness is impaired, the airway should be secured prior to lavage. EMESIS IS CONTRAINDICATED.

Cardiovascular

A maximal limb-lead QRS duration of ≥ 0.10 seconds may be the best indication of the severity of the overdose. Intravenous sodium bicarbonate should be used to maintain the serum pH in the range of 7.45 to 7.55. If the pH response is inadequate, hyperventilation may also be used. Concomitant use of hyperventilation and sodium bicarbonate should be done with extreme caution, with frequent pH monitoring. A pH > 7.60 or a pCO2 < 20 mmHg is undesirable. Dysrhythmias unresponsive to sodium bicarbonate therapy/hyperventilation may respond to lidocaine, bretylium or phenytoin. Type 1A and 1C antiarrhythmics are generally contraindicated (e.g., quinidine, disopyramide, and procainamide). In rare instances, hemoperfusion may be beneficial in acute refractory cardiovascular instability in patients with acute toxicity. However, hemodialysis, peritoneal dialysis, exchange transfusions, and forced diuresis generally have been reported as ineffective in tricyclic antidepressant poisoning.

CNS

In patients with CNS depression, early intubation is advised because of the potential for abrupt deterioration. Seizures should be controlled with benzodiazepines, or if these are ineffective, other anticonvulsants (e.g., phenobarbital, phenytoin). Physostigmine is not recommended except to treat life-threatening symptoms that have been unresponsive to other therapies, and then only in consultation with a poison control center.

Psychiatric Follow-up

Since overdosage is often deliberate, patients may attempt suicide by other means during the recovery phase. Psychiatric referral may be appropriate.

Pediatric Management

The principles of management of child and adult overdosages are similar. It is strongly recommended that the physician contact the local poison control center for specific pediatric treatment.

CONTRAINDICATIONS

Monoamine Oxidase Inhibitors (MAOIs)

The use of MAOIs intended to treat psychiatric disorders with Pamelor or within 14 days of stopping treatment with Pamelor is contraindicated because of an increased risk of serotonin syndrome. The use of Pamelor within 14 days of stopping an MAOI intended to treat psychiatric disorders is also contraindicated (see WARNINGS and DOSAGE AND ADMINISTRATION).

Starting Pamelor in a patient who is being treated with MAOIs such as linezolid or intravenous methylene blue is also contraindicated because of an increased risk of serotonin syndrome (see WARNINGS and DOSAGE AND ADMINISTRATION).

Hypersensitivity to Tricyclic Antidepressants

Cross-sensitivity between Pamelor and other dibenzazepines is a possibility.

Myocardial Infarction

Pamelor is contraindicated during the acute recovery period after myocardial infarction.

Last reviewed on RxList: 11/6/2012
This monograph has been modified to include the generic and brand name in many instances.

CLINICAL PHARMACOLOGY

The mechanism of mood elevation by tricyclic antidepressants is at present unknown. Pamelor is not a monoamine oxidase inhibitor. It inhibits the activity of such diverse agents as histamine, 5-hydroxytryptamine, and acetylcholine. It increases the pressor effect of norepinephrine but blocks the pressor response of phenethylamine. Studies suggest that Pamelor interferes with the transport, release, and storage of catecholamines. Operant conditioning techniques in rats and pigeons suggest that Pamelor has a combination of stimulant and depressant properties.

Last reviewed on RxList: 11/6/2012
This monograph has been modified to include the generic and brand name in many instances.

PATIENT INFORMATION

Medication Guide

Pamelor™
(nortriptyline HCl) Capsules USP and Oral Solution USP

Antidepressant Medicines, Depression and other Serious Mental Illnesses, and Suicidal Thoughts or Actions

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?

  • Antidepressant medicines may increase suicidal thoughts or actions in some children, teenagers, and young adults within the first few months of treatment.
  • 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.
  • 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

Who should not take Pamelor?

Do not take Pamelor if you:

  • take a monoamine oxidase inhibitor (MAOI). Ask your healthcare provider or pharmacist if you are not sure if you take an MAOI, including the antibiotic linezolid.
    • Do not take an MAOI within 2 weeks of stopping Pamelor unless directed to do so by your physician.
    • Do not start Pamelor if you stopped taking an MAOI in the last 2 weeks unless directed to do so by your physician.

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. Talk to the healthcare provider about the side effects of the medicine prescribed for you or your family member.
  • 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.

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

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

Last reviewed on RxList: 11/6/2012
This monograph has been modified to include the generic and brand name in many instances.

>

PATIENT INFORMATION

Medication Guide

Pamelor™
(nortriptyline HCl) Capsules USP and Oral Solution USP

Antidepressant Medicines, Depression and other Serious Mental Illnesses, and Suicidal Thoughts or Actions

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?

  • Antidepressant medicines may increase suicidal thoughts or actions in some children, teenagers, and young adults within the first few months of treatment.
  • 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.
  • 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

Who should not take Pamelor?

Do not take Pamelor if you:

  • take a monoamine oxidase inhibitor (MAOI). Ask your healthcare provider or pharmacist if you are not sure if you take an MAOI, including the antibiotic linezolid.
    • Do not take an MAOI within 2 weeks of stopping Pamelor unless directed to do so by your physician.
    • Do not start Pamelor if you stopped taking an MAOI in the last 2 weeks unless directed to do so by your physician.

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. Talk to the healthcare provider about the side effects of the medicine prescribed for you or your family member.
  • 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.

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

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

Last reviewed on RxList: 11/6/2012
This monograph has been modified to include the generic and brand name in many instances.

Pamelor™
(nortriptyline HCl) Capsules USP (nortriptyline HCl) and Oral Solution USP

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 nortriptyline hydrochloride 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. Nortriptyline hydrochloride is not approved for use in pediatric patients (see WARNINGS, Clinical Worsening and Suicide Risk; PATIENT INFORMATION; and PRECAUTIONS, Pediatric Use).

DRUG DESCRIPTION

Pamelor™ (nortriptyline HCl) is 1-propanamine, 3-(10,11-dihydro-5Hdibenzo[a,d]cyclohepten-5-ylidene)-N-methyl-, hydrochloride.

The structural formula is as follows:

Pamelor™ (nortriptyline HCl)  Structural Formula Illustration

C19H21N HCl        MW = 299.84

10 mg, 25 mg, 50 mg, and 75 mg Capsules

Active Ingredient: nortriptyline hydrochloride USP.

10 mg, 25 mg, and 75 mg Capsules

Inactive Ingredients: D&C Yellow #10, FD&C Yellow #6, gelatin, silicone fluid, starch, and titanium dioxide.

50 mg Capsules

Inactive Ingredients: gelatin, silicone fluid, starch, and titanium dioxide.

Solution

Active Ingredient: nortriptyline hydrochloride USP.

Inactive Ingredients: alcohol, benzoic acid, flavoring, purified water, and sorbitol.

Last reviewed on RxList: 11/6/2012
This monograph has been modified to include the generic and brand name in many instances.

Pamelor™
(nortriptyline HCl) Capsules USP (nortriptyline HCl) and Oral Solution USP

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 nortriptyline hydrochloride 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. Nortriptyline hydrochloride is not approved for use in pediatric patients (see WARNINGS, Clinical Worsening and Suicide Risk; PATIENT INFORMATION; and PRECAUTIONS, Pediatric Use).

DRUG DESCRIPTION

Pamelor™ (nortriptyline HCl) is 1-propanamine, 3-(10,11-dihydro-5Hdibenzo[a,d]cyclohepten-5-ylidene)-N-methyl-, hydrochloride.

The structural formula is as follows:

Pamelor™ (nortriptyline HCl)  Structural Formula Illustration

C19H21N HCl        MW = 299.84

10 mg, 25 mg, 50 mg, and 75 mg Capsules

Active Ingredient: nortriptyline hydrochloride USP.

10 mg, 25 mg, and 75 mg Capsules

Inactive Ingredients: D&C Yellow #10, FD&C Yellow #6, gelatin, silicone fluid, starch, and titanium dioxide.

50 mg Capsules

Inactive Ingredients: gelatin, silicone fluid, starch, and titanium dioxide.

Solution

Active Ingredient: nortriptyline hydrochloride USP.

Inactive Ingredients: alcohol, benzoic acid, flavoring, purified water, and sorbitol.

Last reviewed on RxList: 11/6/2012
This monograph has been modified to include the generic and brand name in many instances.

Pamelor™
(nortriptyline HCl) Capsules USP (nortriptyline HCl) and Oral Solution USP

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 nortriptyline hydrochloride 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. Nortriptyline hydrochloride is not approved for use in pediatric patients (see WARNINGS, Clinical Worsening and Suicide Risk; PATIENT INFORMATION; and PRECAUTIONS, Pediatric Use).

DRUG DESCRIPTION

Pamelor™ (nortriptyline HCl) is 1-propanamine, 3-(10,11-dihydro-5Hdibenzo[a,d]cyclohepten-5-ylidene)-N-methyl-, hydrochloride.

The structural formula is as follows:

Pamelor™ (nortriptyline HCl)  Structural Formula Illustration

C19H21N HCl        MW = 299.84

10 mg, 25 mg, 50 mg, and 75 mg Capsules

Active Ingredient: nortriptyline hydrochloride USP.

10 mg, 25 mg, and 75 mg Capsules

Inactive Ingredients: D&C Yellow #10, FD&C Yellow #6, gelatin, silicone fluid, starch, and titanium dioxide.

50 mg Capsules

Inactive Ingredients: gelatin, silicone fluid, starch, and titanium dioxide.

Solution

Active Ingredient: nortriptyline hydrochloride USP.

Inactive Ingredients: alcohol, benzoic acid, flavoring, purified water, and sorbitol.

Last reviewed on RxList: 11/6/2012
This monograph has been modified to include the generic and brand name in many instances.

Pamelor Patient Information Including Side Effects

Brand Names: Pamelor

Generic Name: nortriptyline (Pronunciation: nor TRIP ti leen)

What is nortriptyline (Pamelor)?

Nortriptyline is in a group of drugs called tricyclic antidepressants. Nortriptyline affects chemicals in the brain that may become unbalanced.

Nortriptyline is used to treat symptoms of depression.

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

Nortriptyline 10 mg-MYL

red, imprinted with MYLAN 1410

Nortriptyline 10 mg-TEV

orange/white, imprinted with TEVA, 10 mg 0810

Nortriptyline 10 mg-WAT

green/white, imprinted with NORTIPTYLINE, DAN 10 mg

Nortriptyline 25 mg-GG

white, imprinted with GG 566

Nortriptyline 25 mg-MYL

peach/red, imprinted with MYLAN 2325

Nortriptyline 25 mg-TEV

orange/white, imprinted with TEVA, 0811 25mg

Nortriptyline 25 mg-WAT

green/white, imprinted with NORTRIPTYLINE, DAN 25 mg

Nortriptyline 50 mg-GG

white, imprinted with GG 567

Nortriptyline 50 mg-MYL

red/yellow, imprinted with MYLAN 3250

Nortriptyline 50 mg-TEV

white, imprinted with TEVA, 50mg 0812

Nortriptyline 50 mg-WAT

white, imprinted with NORTRIPTYLINE, DAN 50 mg

Nortriptyline 75 mg-GG

green, imprinted with NORTRIPTYLINE 75 mg, 253 CP

Nortriptyline 75 mg-MYL

brown/orange, imprinted with MYLAN 4175

Nortriptyline 75 mg-TEV

orange, imprinted with 93 813, TEVA, 75mg 0813

Nortriptyline 75 mg-WAT

green, imprinted with NORTRIPTYLINE, DAN 75 mg

Pamelor 10 mg

orange/yellow, imprinted with PAMELOR10MG, SANDOZ

Pamelor 25 mg

orange/white, imprinted with PAMELOR 25 mg, SANDOZ

What are the possible side effects of nortriptyline (Pamelor)?

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.

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.

Call your doctor at once if you have any of these serious side effects:

  • fast, pounding, or uneven heart rate;
  • chest pain or heavy feeling, pain spreading to the arm or shoulder, nausea, sweating, general ill feeling;
  • sudden numbness or weakness, especially on one side of the body;
  • sudden headache, confusion, problems with vision, speech, or balance;
  • confusion, hallucinations, or seizure (convulsions);
  • easy bruising or bleeding, unusual weakness;
  • restless muscle movements in your eyes, tongue, jaw, or neck;
  • tremors;
  • extreme thirst with headache, nausea, vomiting, and weakness;
  • feeling light-headed or fainting; or
  • urinating less than usual or not at all.

Less serious side effects may include:

  • nausea, vomiting, stomach pain, loss of appetite;
  • constipation or diarrhea;
  • weight changes;
  • dry mouth, unpleasant taste;
  • weakness, lack of coordination;
  • numbness or tingly feeling;
  • blurred vision, headache, ringing in your ears;
  • mild skin rash;
  • breast swelling (in men or women); or
  • increased sweating.

This is not a complete list of side effects and others may occur. Tell your doctor about any unusual or bothersome side effect. You may report side effects to FDA at 1-800-FDA-1088.

Read the Pamelor (nortriptyline hcl) Side Effects Center for a complete guide to possible side effects »

What is the most important information I should know about nortriptyline (Pamelor)?

Do not use nortriptyline if you have recently had a heart attack, or if you have used an MAO inhibitor such as isocarboxazid (Marplan), phenelzine (Nardil), rasagiline (Azilect), selegiline (Eldepryl, Emsam), or tranylcypromine (Parnate) within the past 14 days.

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.

Side Effects Centers

Pamelor Patient Information including How Should I Take

What should I discuss with my healthcare provider before taking nortriptyline (Pamelor)?

Do not use this medication if you are allergic to nortriptyline, or if you have recently had a heart attack.

Do not use nortriptyline if you have used an MAO inhibitor such as isocarboxazid (Marplan), phenelzine (Nardil), rasagiline (Azilect), selegiline (Eldepryl, Emsam), or tranylcypromine (Parnate) within the past 14 days. Serious, life-threatening side effects can occur if you take nortriptyline before the MAO inhibitor has cleared from your body.

Before taking nortriptyline, tell your doctor if you are allergic to any drugs, or if you have:

  • heart disease;
  • a history of heart attack, stroke, or seizures;
  • bipolar disorder (manic-depression);
  • schizophrenia or other mental illness;
  • diabetes (nortriptyline may raise or lower blood sugar);
  • overactive thyroid;
  • glaucoma; or
  • problems with urination.

If you have any of these conditions, you may need a dose adjustment or special tests to safely take nortriptyline.

You may have thoughts about suicide when you first start taking an antidepressant, especially if you are younger than 24 years old. Tell your doctor if you have worsening symptoms of 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.

This medication may be harmful to an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant during treatment.

It is not known whether nortriptyline passes into breast milk or if it could harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby.

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

Do not give this medication to anyone under 18 years old without the advice of a doctor.

How should I take nortriptyline (Pamelor)?

Take this medication exactly as it was prescribed for you. Do not take the medication in larger amounts, or take it for longer than recommended by your doctor. Your doctor may occasionally change your dose to make sure you get the best results from this medication. Follow the directions on your prescription label.

If you need to have any type of surgery, tell the surgeon ahead of time that you are taking nortriptyline. You may need to stop using the medicine for a short time.

Do not stop using nortriptyline without first talking to your doctor. You may need to use less and less before you stop the medication completely. Stopping this medication suddenly could cause you to have unpleasant side effects.

It may take a few weeks of using this medicine before your symptoms improve. For best results, keep using the medication as directed. Talk with your doctor if your symptoms do not improve during treatment with nortriptyline.

Store nortriptyline at room temperature away from moisture and heat.

Side Effects Centers

Pamelor Patient Information including If I Miss a Dose

What happens if I miss a dose (Pamelor)?

Take the missed dose as soon as you remember. If it is almost time for your next dose, skip the missed dose and take the medicine at the next regularly scheduled time. Do not take extra medicine to make up the missed dose.

What happens if I overdose (Pamelor)?

Seek emergency medical attention if you think you have used too much of this medicine. An overdose of nortriptyline can be fatal.

Overdose symptoms may include extreme drowsiness, confusion, agitation, hallucinations, blurred vision, vomiting, muscle stiffness, feeling hot or cold, fainting, seizure (convulsions), or coma.

What should I avoid while taking nortriptyline (Pamelor)?

Avoid drinking alcohol. It can cause dangerous side effects when taken together with nortriptyline.

Avoid using other medicines that make you sleepy (such as cold medicine, pain medication, muscle relaxers, medicine for seizures, or other antidepressants). They can add to sleepiness caused by nortriptyline.

Grapefruit and grapefruit juice may interact with nortriptyline. Discuss the use of grapefruit products with your doctor before increasing or decreasing the amount of grapefruit products in your diet.

Nortriptyline can cause side effects that may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be awake and alert.

Avoid exposure to sunlight or artificial UV rays (sunlamps or tanning beds). Nortriptyline can make your skin more sensitive to sunlight and sunburn may result. Use a sunscreen (minimum SPF 15) and wear protective clothing if you must be out in the sun.

What other drugs will affect nortriptyline (Pamelor)?

Before taking nortriptyline, tell your doctor if you have used an "SSRI" antidepressant in the past 5 weeks, such as citalopram (Celexa), escitalopram (Lexapro), fluoxetine (Prozac, Sarafem), fluvoxamine (Luvox), paroxetine (Paxil), or sertraline (Zoloft).

Before taking nortriptyline, tell your doctor if you are currently using any of the following drugs:

  • cimetidine (Tagamet);
  • guanethidine (Ismelin);
  • reserpine; or
  • heart rhythm medications such as flecainide (Tambocor), propafenone (Rhythmol), or quinidine (Cardioquin, Quinidex, Quinaglute).

This list is not complete and there are many other medicines that can interact with nortriptyline. Tell your doctor about all the prescription and over-the-counter medications you use. This includes vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start using a new medication without telling your doctor. Keep a list with you of all the medicines you use and show this list to any doctor or other healthcare provider who treats you.

Where can I get more information?

Your pharmacist can provide more information about nortriptyline.


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: 8.03. Revision date: 12/15/2010.

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.

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Side Effects Centers

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