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Nortriptyline Hcl 25 Mg Cap 500

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Product Properties:

Description -
DESI Drug Ind -
DESI2 Drug Ind AB
Drug Category NJ
Drug Type Code N
FDA Approval Date 06/11/2007
FDA Therap Equiv CAP
HCPCS -
Market Entry Date -
Medical Coverage -
Termination Date 1
Unit 500
Units Per Pkg 05/08/2000
Active Ingredients 1502 nortriptyline HCl 894713
AHFS Class 28160428 TRICYCLICS, OTHER NOREPI-RU INHIBITORS
DEA Class NC
Dose Form CAPSULE
Fine Line Class 850085008510 All Rx Products
Gen Code and Des 46060 nortriptyline HCl ORAL CAPSULE 25 MG
Inactive Ingredients 10138 blue dye; 10141 red dye; 10143 yellow dye; 2549 gelatin 9000708
OMP Family -
Product Category RX Pharmaceuticals
Strength 25MG
Common Brand Name COMMON BRAND NAME(S): Aventyl, Pamelor
Drug Interaction DRUG INTERACTIONS: Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval. Some products that may interact with this drug include: arbutamine, "blood thinners" (such as warfarin), disulfiram, thyroid supplements, anticholinergic drugs (such as belladonna alkaloids), certain drugs for high blood pressure (drugs that work in the brain such as clonidine, guanabenz). Taking MAO inhibitors with this medication may cause a serious (possibly fatal) drug interaction. Avoid taking MAO inhibitors (isocarboxazid, linezolid, metaxalone, methylene blue, moclobemide, phenelzine, procarbazine, rasagiline, safinamide, selegiline, tranylcypromine) during treatment with this medication. Most MAO inhibitors should also not be taken for two weeks before and after treatment with this medication. Ask your doctor when to start or stop taking this medication. The risk of serotonin syndrome/toxicity increases if you are also taking other drugs that increase serotonin. Examples include street drugs such as MDMA/"ecstasy," St. John's wort, certain antidepressants (including SSRIs such as fluoxetine/paroxetine, SNRIs such as duloxetine/venlafaxine), among others. The risk of serotonin syndrome/toxicity may be more likely when you start or increase the dose of these drugs. Other medications can affect the removal of nortriptyline from your body, thereby affecting how nortriptyline works. These drugs include cimetidine, drugs to treat irregular heart rate (such as quinidine/propafenone/flecainide). This is not a complete list. Many drugs besides nortriptyline may affect the heart rhythm (QT prolongation in the EKG), including amiodarone, dofetilide, pimozide, procainamide, quinidine, sotalol, macrolide antibiotics (such as erythromycin), among others. Before using nortriptyline, report all medications you are currently using to your doctor or pharmacist. Tell your doctor or pharmacist if you are taking other products that cause drowsiness, including alcohol, marijuana (cannabis), antihistamines (such as cetirizine, diphenhydramine), drugs for sleep or anxiety (such as alprazolam, diazepam, zolpidem), muscle relaxants, and opioid pain relievers (such as codeine). Check the labels on all your medicines (such as allergy or cough-and-cold products) because they may contain decongestants or ingredients that cause drowsiness. Ask your pharmacist about using those products safely. Nortriptyline is very similar to amitriptyline. Do not use medications containing amitriptyline while using nortriptyline.
Allocation Period -
Case Quantity 12
Drug Form Pack Size 500
Form CAPSULES
Hazard Code -
Listed Chemical -
NIOSH Code -
Orange Book AB Products meeting necessary bioequivalence requirements.
Retail Pack Quantity 1
Returnable Status Returnable
Special Storage Cond 00 None
Temp Zone 20 Cool-Store Cont Temp
Unit EA
Unit Size 500
How to Use HOW TO USE: Read the Medication Guide provided by your pharmacist before you start taking nortriptyline and each time you get a refill. If you have any questions, consult your doctor or pharmacist. Take this medication by mouth as directed by your doctor, usually 1 to 4 times daily. If you are using the liquid form, measure the dose carefully using a special measuring device/spoon. Do not use a household spoon because you may not get the correct dose. The dosage is based on your medical condition and response to treatment. To reduce your risk of side effects (such as dry mouth, dizziness), your doctor may direct you to start this medication at a low dose and gradually increase your dose. Follow your doctor's instructions carefully. Take this medication regularly in order to get the most benefit from it. To help you remember, take it at the same time(s) each day. Do not increase your dose or use this drug more often or for longer than prescribed. Your condition will not improve any faster, and your risk of side effects will increase. Keep taking this medication even if you feel well. Do not stop taking this medication without consulting your doctor. Some conditions may become worse when this drug is suddenly stopped. Also, you may experience symptoms such as mood swings, headache, tiredness, and sleep change. To prevent these symptoms while you are stopping treatment with this drug, your doctor may reduce your dose gradually. Consult your doctor or pharmacist for more details. Report any new or worsening symptoms right away. This medication may not work right away. You may see some benefit within a week. However, it may take up to 4 weeks before you feel the full effect. Tell your doctor if your condition lasts or gets worse (such as your feelings of sadness get worse, or you have thoughts of suicide).
Missed Dose MISSED DOSE: If you miss a dose, take it as soon as you remember. If it is near the time of the next dose, skip the missed dose. Take your next dose at the regular time. Do not double the dose to catch up.
Notes NOTES: Do not share this medication with others. Lab and/or medical tests (such as EKG, liver function, nortriptyline blood level) may be done while you are taking this medication. Keep all medical and lab appointments. Consult your doctor for more details.
Overdose OVERDOSE: If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center. Symptoms of overdose may include: extreme drowsiness, hallucinations, fast/irregular heartbeat, fainting, slow/shallow breathing, seizures.
Phonetic Pronunciation (nor-TRIP-ti-leen)
Precautions PRECAUTIONS: See also Warning section. Before taking nortriptyline, tell your doctor or pharmacist if you are allergic to it; or to other tricyclic antidepressants (such as amitriptyline); 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. Before using this medication, tell your doctor or pharmacist your medical history, especially of: breathing problems, liver problems, recent heart attack, problems urinating (such as due to enlarged prostate), overactive thyroid (hyperthyroidism), personal or family history of glaucoma (angle-closure type), personal or family history of mental/mood conditions (such as bipolar disorder, psychosis), family history of suicide, seizures, conditions that may increase your risk of seizures (such as other brain disease, alcohol withdrawal). Nortriptyline may cause a condition that affects the heart rhythm (QT prolongation). QT prolongation can rarely cause serious (rarely fatal) fast/irregular heartbeat and other symptoms (such as severe dizziness, fainting) that need medical attention right away. The risk of QT prolongation may be increased if you have certain medical conditions or are taking other drugs that may cause QT prolongation. Before using nortriptyline, tell your doctor or pharmacist of all the drugs you take and if you have any of the following conditions: certain heart problems (heart failure, slow heartbeat, Brugada syndrome, QT prolongation in the EKG), family history of certain heart problems (QT prolongation in the EKG, sudden cardiac death). Low levels of potassium or magnesium in the blood may also increase your risk of QT prolongation. This risk may increase if you use certain drugs (such as diuretics/"water pills") or if you have conditions such as severe sweating, diarrhea, or vomiting. Talk to your doctor about using nortriptyline safely. This drug may make you dizzy or drowsy or blur your vision. Alcohol or marijuana (cannabis) can make you more dizzy or drowsy. Do not drive, use machinery, or do anything that needs alertness or clear vision until you can do it safely. Limit alcoholic beverages. Talk to your doctor if you are using marijuana (cannabis). Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products). This medication may make you more sensitive to the sun. Limit your time in the sun. Avoid tanning booths and sunlamps. Use sunscreen and wear protective clothing when outdoors. Tell your doctor right away if you get sunburned or have skin blisters/redness. The liquid form of this medication may contain alcohol. Caution is advised if you have diabetes, alcohol dependence, liver disease, or any other condition that requires you to limit/avoid alcohol in your diet. Ask your doctor or pharmacist about using this product safely. If you have diabetes, this drug may make it harder to control your blood sugar levels. Monitor your blood sugar levels regularly and tell your doctor of the results. Your doctor may need to adjust your diabetes medication, exercise program, or diet. Older adults may be more sensitive to the side effects of this drug, especially dry mouth, dizziness, confusion, difficulty urinating, and QT prolongation (see above). During pregnancy, this medication should be used only when clearly needed. Since untreated mental/mood problems (such as depression, anxiety, panic disorder) can be a serious condition, do not stop using this medication unless directed by your doctor. If you are planning pregnancy, become pregnant, or think you may be pregnant, immediately discuss with your doctor the benefits and risks of using this medication during pregnancy. This medication passes into breast milk and may have undesirable effects on a nursing infant. Consult your doctor before breast-feeding.
Side Effects SIDE EFFECTS: See also Warning section. Drowsiness, dizziness, dry mouth, blurred vision, constipation, weight gain, or trouble urinating may occur. If any of these effects last or get worse, notify your doctor or pharmacist promptly. To reduce the risk of dizziness and lightheadedness, get up slowly when rising from a sitting or lying position. To relieve dry mouth, suck on (sugarless) hard candy or ice chips, chew (sugarless) gum, drink water, or use a saliva substitute. To prevent constipation, eat dietary fiber, drink enough water, and exercise. You may also need to take a laxative. Ask your pharmacist which type of laxative is right for you. Remember that this medication has been prescribed because your doctor 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 right away if you have any serious side effects, including: heartburn that doesn't go away, shaking, mask-like facial expressions, muscle spasms, severe stomach/abdominal pain, decreased sexual ability/desire, enlarged/painful breasts. This medication may increase serotonin and rarely cause a very serious condition called serotonin syndrome/toxicity. The risk increases if you are also taking other drugs that increase serotonin, so tell your doctor or pharmacist of all the drugs you take (see Drug Interactions section). Get medical help right away if you develop some of the following symptoms: fast heartbeat, hallucinations, loss of coordination, severe dizziness, severe nausea/vomiting/diarrhea, twitching muscles, unexplained fever, unusual agitation/restlessness. Get medical help right away if you have any very serious side effects, including: severe dizziness, fast/irregular heartbeat, fainting, seizures, eye pain/swelling/redness, widened pupils, vision changes (such as seeing rainbows around lights at night). A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe 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 or at www.fda.gov/medwatch. In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.
Storage STORAGE: Store at room temperature away from light and moisture. Do not store in the bathroom. Keep all medications 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.
Uses USES: This medication is used to treat mental/mood problems such as depression. It may help improve mood and feelings of well-being, relieve anxiety and tension, and increase your energy level. This medication belongs to a class of medications called tricyclic antidepressants. It works by affecting the balance of certain natural chemicals (neurotransmitters) in the brain.

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Nortriptyline Hcl 25 Mg Cap 500 is manufactured by TARO PHARMACEUTICAL INDUSTRIES LTD.
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