Complete SPL Sections#
SUICIDALITY AND ANTIDEPRESSANT DRUGS
BOXED WARNING SECTION
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 Oral Solution 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, Precautions: Information for Patients, and Precautions: Pediatric Use)
DESCRIPTION
DESCRIPTION SECTION
Nortriptyline Hydrochloride, USP is 1-propanamine, 3-(10, 11-dihydro-5 H -dibenzo [a,d] cyclohepten-5-ylidene)- N -methyl, hydrochloride. Its molecular weight is 299.8, and its molecular formula is C 19 H 21 N•HCl. The oral solution contains nortriptyline hydrochloride equivalent to 10 mg/5 mL (38.0 µmol) of the base and 4% alcohol. It also contains benzoic acid, flavors, sorbitol, and water. The structural formula is as follows:
ACTIONS
CLINICAL PHARMACOLOGY SECTION
The mood elevating mechanism of tricyclic antidepressants is at present unknown. Nortriptyline hydrochloride 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 nortriptyline hydrochloride interferes with the transport, release, and storage of catecholamines. Operant conditioning techniques in rats and pigeons suggest that nortriptyline hydrochloride has a combination of stimulant and depressant properties.
INDICATIONS
INDICATIONS AND USAGE SECTION
Nortriptyline hydrochloride is indicated for the relief of symptoms of depression. Endogenous depressions are more likely to be alleviated than are other depressive states.
CONTRAINDICATIONS
CONTRAINDICATIONS SECTION
The concurrent use of nortriptyline hydrochloride or other tricyclic antidepressants with a monoamine oxidase (MAO) inhibitor is contraindicated. Hyperpyretic crises, severe convulsions, and fatalities have occurred when similar tricyclic antidepressants were used in such combinations. It is advisable to discontinue the MAO inhibitor at least 2 weeks before treatment with nortriptyline hydrochloride is to be started. Patients hypersensitive to nortriptyline hydrochloride should not be given the drug. Cross-sensitivity between nortriptyline hydrochloride and other dibenzazepines is a possibility. Nortriptyline hydrochloride is contraindicated during the acute recovery period after myocardial infarction.
WARNINGS
WARNINGS SECTION
PRECAUTIONS
PRECAUTIONS SECTION
ADVERSE REACTIONS
ADVERSE REACTIONS SECTION
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 these 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 of EEG patterns; tinnitus. Anticholinergic --Dry mouth and, rarely, associated sublingual adenitis or gingivitis; 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; aplastic anemia; eosinophilia; purpura; thrombocytopenia. Gastrointestinal --Nausea and vomiting, anorexia, epigastric distress, diarrhea; peculiar taste, stomatitis, abdominal cramps, black tongue, constipation, paralytic ileus. 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, hepatitis, and liver necrosis; 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.
OVERDOSAGE
OVERDOSAGE SECTION
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.
DOSAGE AND ADMINISTRATION
DOSAGE AND ADMINISTRATION SECTION
Nortriptyline hydrochloride is not recommended for pediatric patients. Nortriptyline hydrochloride is administered orally in the form of an oral solution. Lower than usual dosages are recommended for elderly patients. The use of lower dosages for outpatients is more important than for hospitalized patients who will be treated under close supervision. The physician should initiate dosage at a low level and increase it gradually, checking the clinical response carefully and noting 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.
HOW SUPPLIED
HOW SUPPLIED SECTION
Liquid, Oral Solution: 10 mg * /5 mL -- (16 fl oz) NDC 63304-202-01 * Equivalent to base. Store at 20 - 25° C (68 - 77° F). (See USP Controlled Room Temperature). Manufactured for: Ranbaxy Pharmaceuticals Inc. Jacksonville, FL 32257 USA by: Ohm Laboratories Inc. Gloversville, NY 12078 USA August 2007
MEDICATION GUIDE
SPL MEDGUIDE SECTION
