Страна: САЩ
Език: английски
Източник: NLM (National Library of Medicine)
NORTRIPTYLINE HYDROCHLORIDE (UNII: 00FN6IH15D) (NORTRIPTYLINE - UNII:BL03SY4LXB)
SpecGx LLC
NORTRIPTYLINE HYDROCHLORIDE
NORTRIPTYLINE 10 mg
ORAL
PRESCRIPTION DRUG
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. 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 myoc
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 “” 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 ““ 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 “” 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 “” in black. Bottles of 30..................NDC 0406-9913-03 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. Mallinckrodt, the “M” brand mark, the Mallinckrodt Pharmaceuticals logo, and other brands are trademarks of a Mallinckrodt company. © 2019 Mallinckrodt. Manufactured by: Patheon Inc. Whitby, Ontario, Canada L1N 5Z5 Manufactured for: SpecGx LLC Webster Groves, MO 63119 USA Rev 04/2019 Mallinckrodt™ Pharmaceuticals
New Drug Application
PAMELOR- NORTRIPTYLINE HYDROCHLORIDE CAPSULE SpecGx LLC ---------- MEDICATION GUIDE – PAMELOR™ (NORTRIPTYLINE HCL) CAPSULES 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. Talk to your, or your family member's, healthcare provider about: • all risks and benefits of treatment with antidepressant medicines • all treatment choices for depression or other serious mental illness What is the most important information I should know about antidepressant medicines, depression and other serious mental illnesses, and suicidal thoughts or actions? 1. Antidepressant medicines may increase suicidal thoughts or actions in some children, teenagers, and young adults within the first few months of treatment. 2. Depression and other serious mental illnesses are the most important causes of suicidal thoughts and actions. Some people may have a particularly high risk of having suicidal thoughts or actions. These include people who have (or have a family history of) bipolar illness (also called manic- depressive illness) or suicidal thoughts or actions. 3. How can I watch for and try to prevent suicidal thoughts and actions in myself or a family member? • Pay close attention to any changes, especially sudden changes, in mood, behaviors, thoughts, or feelings. This is very important when an antidepressant medicine is started or when the dose is changed. • Call the healthcare provider right away to report new or sudden changes in mood, behavior, thoughts, or feelings. • Keep all follow-up visits with the healthcare provider as scheduled. Call the healthcare provider between visits as needed, especially if you have concerns about symptoms. Call a healthcare provider right away if you or your family member has any of the following symptoms, especially if they are new, worse, or worry you: • thoughts about suicide or dying • attempts to commit suicide • new or wors Прочетете целия документ
PAMELOR- NORTRIPTYLINE HYDROCHLORIDE CAPSULE SPECGX LLC ---------- PAMELOR _(NORTRIPTYLINE HCL) CAPSULES USP_ RX ONLY 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; PRECAUTIONS, INFORMATION FOR PATIENTS;_ AND_ PRECAUTIONS, PEDIATRIC USE). DESCRIPTION Pamelor (nortriptyline HCl) is 1-propanamine, 3-(10,11-dihydro-_5H_-dibenzo[_a,d_] cyclohepten-5- ylidene)-_N_-methyl-, hydrochloride. The structural formula is as follows: _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. CLINICAL PHARMACOLOGY The mechanism of mood elevation by tricyclic antidepressants is at present Прочетете целия документ