Nortriptyline HCL 25 mg/1
Nortriptyline HCL · CAPSULE · Direct_rx
Nortriptyline HCL is a capsule containing nortriptyline hcl at 25 mg/1, taken oral. Manufactured by Direct_rx.
Key Facts
- Brand Name
- Nortriptyline HCL
- Generic Name
- Nortriptyline HCL
- NDC Code (Product)
72189-561- Manufacturer
- Direct_rx
- Strength
- 25 mg/1
- Dosage Form
- CAPSULE
- Route
- ORAL
- Marketing Status
- Application #
- ANDA073556
- Marketing Start
- 06/20/2024
Recall History
Aidapak Services, LLC
Labeling: Label Mixup: NORTRIPTYLINE HCL, Capsule, 10 mg may have potentially been mislabeled as the following drug: VALSARTAN, Tablet, 80 mg, NDC 00078035834, Pedigree: AD70585_1, EXP: 5/29/2014.
Aidapak Services, LLC
Labeling: Label Mixup: NORTRIPTYLINE HCL, Capsule, 50 mg may have potentially been mislabeled as one of the following drugs: ROSUVASTATIN CALCIUM, Tablet, 5 mg, NDC 00310075590, Pedigree: AD21811_10, EXP: 5/2/2014; LIOTHYRONINE SODIUM, Tablet, 5 mcg, NDC 42794001802, Pedigree: AD46414_38, EXP: 5/16/2014.
Taro Pharmaceuticals U.S.A., Inc.
CGMP deviations.
Direct Rx
cGMP deviations: The quantity of active ingredient used for the product lot was inadvertently taken from an ingredient lot from an alternate supplier before that specific lot was formally qualified for use by the manufacturing site.
Aidapak Services, LLC
Labeling: Label Mixup: NORTRIPTYLINE HCL, Capsule, 75 mg may have potentially been mislabeled as one of the following drugs: guaiFENesin ER, Tablet, 600 mg, NDC 45802049878, Pedigree: AD21790_58, EXP: 5/1/2014; MIRTAZAPINE, Tablet, 7.5 mg, NDC 59762141509, Pedigree: W003693, EXP: 4/30/2014.
Full Prescribing Information
Indications & Usage
Nortriptyline hydrochloride, USP is indicated for the relief of symptoms of depression. Endogenous depressions are more likely to be alleviated than are other depressive states.
Dosage & Administration
Nortriptyline hydrochloride is not recommended for children. Nortriptyline hydrochloride is administered orally in the form of capsules. 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. El…
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…
Contraindications
Monoamine Oxidase Inhibitors (MAOIs) The use of MAOIs intended to treat psychiatric disorders with nortriptyline hydrochloride or within 14 days of stopping treatment with nortriptyline hydrochloride is contraindicated because of an increased risk of serotonin syndrome. The use of nortriptyline hydrochloride within 14 days of stopping an MAOI intended to treat psychiatric disorders is also contraindicated (see WARNINGS and DOSAGE AND ADMINISTRATION). Starting nortriptyline hydrochloride 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 nortriptyline hydrochloride and other dibenzazepines is a possibility. Myocardial Infarction Nortriptyline hydrochloride is contraindicated during the acute recovery period after myocardial infarction.
Adverse Reactions
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 f…
Frequently Asked Questions
What is Nortriptyline HCL used for?
Nortriptyline HCL contains Nortriptyline HCL. It is a capsule taken oral. Consult your doctor for specific uses.
Is Nortriptyline HCL a controlled substance?
Nortriptyline HCL is not classified as a controlled substance by the DEA.
What is the generic name for Nortriptyline HCL?
The generic name for Nortriptyline HCL is Nortriptyline HCL. There are no other listed brand versions of Nortriptyline HCL.
What is the NDC code for Nortriptyline HCL 25 mg/1?
The NDC (National Drug Code) for Nortriptyline HCL 25 mg/1 is 72189-561, listed by Direct_rx.
Other Nortriptyline HCL Dosages
Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.
Data from openFDA · Public domain (CC0 1.0)