PARNATE Film-coated tablet (2021)
Βιβλιογραφική αναφορά
Συγγραφείς
Concordia Pharmaceuticals Inc.
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BOXED WARNING SECTION
<b>WARNING: SUICIDAL THOUGHTS AND BEHAVIORS and HYPERTENSIVE CRISIS WITH SIGNIFICANT TYRAMINE USE</b> <b><u>Suicidal Thoughts and Behaviors</u></b> <b>Antidepressants increased the risk of suicidal thoughts ...
1. Indications and Usage
PARNATE is indicated for the treatment of major depressive disorder (MDD) in adult patients who have not responded adequately to other antidepressants. PARNATE is not indicated for the initial treatment ...
2. Dosage and Administration
2.1 Recommended Dosage PARNATE tablets are for oral use. The recommended dosage is 30 mg per day (in divided doses). If patients do not have an adequate response, increase the dosage in increments of 10 ...
3. Dosage Forms and Strengths
Tablets containing tranylcypromine sulfate equivalent to 10 mg tranylcypromine are round, rose‑red, film‑coated, and debossed on one side with PARNATE and SB.
4. Contraindications
4.1 Combination with Certain Drugs Concomitant use of PARNATE or use in rapid succession with the products in Table 1 is contraindicated. Such use may cause severe or life-threatening reactions such as ...
5. Warnings and Precautions
5.1 Suicidal Thoughts and Behaviors in Adolescents and Young Adults In pooled analyses of placebo-controlled trials of antidepressant drugs (SSRIs and other antidepressant classes) that included approximately ...
6. Adverse Reactions
The following adverse reactions are described in greater detail in other sections: Suicidal thoughts and behaviors <em>[see Warnings and Precautions (5.1)]</em> Hypertensive crisis and hypertension <em> ...
7. Drug Interactions
7.1 Clinically Significant Drug Interactions Tables 3 and 4 lists drug classes and individual products, respectively, with a potential for interaction with PARNATE, describes the predominant observed or ...
8.1. Pregnancy
Risk Summary There are limited published reports of placental infarction and congenital anomalies in association with use of PARNATE during pregnancy; however, these reports may not adequately inform the ...
8.2. Lactation
Risk Summary Tranylcypromine is present in human milk. There is no available information on the effects of tranylcypromine on milk production. There is no available information on the effects of tranylcypromine ...
8.4. Pediatric Use
Safety and effectiveness of PARNATE in the pediatric population have not been established. All risks associated with the use of PARNATE, including the risk of suicidal thoughts and behavior, apply to adults ...
8.5. Geriatric Use
Older patients may be at greater risk of postural hypotension and other serious adverse reactions <em>[see Warnings and Precautions (5)]</em>. In general, dose selection for an elderly patient should be ...
9.2. Abuse
Abuse of PARNATE has been reported. Some of these patients had a history of previous substance abuse. The potential for abuse and the increased risk of serious adverse reactions with higher doses should ...
9.3. Dependence
Dependence, evidenced by precipitation of withdrawal effects following abrupt discontinuation of PARNATE has been reported. Reported withdrawal effects included delirium (even with low daily doses), restlessness, ...
10. Overdosage
10.1 Overdosage Symptoms, Signs, and Laboratory Abnormalities Overdose of PARNATE can cause the adverse reactions generally associated with PARNATE administration <em>[see Warnings and Precautions (5), ...
11. Description
Tranylcypromine sulfate, the active ingredient of PARNATE, is a non-hydrazine MAOI. The chemical name is (±)‑<em>trans</em>‑2‑phenylcyclopropylamine sulfate (2:1). The molecular formula is (C<sub>9</sub> ...
12.1. Mechanism of Action
The mechanism of action of PARNATE as an antidepressant is not fully understood, but is presumed to be linked to potentiation of monoamine neurotransmitter activity in the central nervous system (CNS) ...
12.2. Pharmacodynamics
Although tranylcypromine is eliminated in 24 hours, recovery MAO activity take up to 3 to 5 days <em>[see Warnings and Precautions (5.9)]</em>.
13.1. Carcinogenesis, Mutagenesis, Impairment of Fertility
No carcinogenesis, mutagenesis, or fertility impairment studies were conducted.
16.1. How Supplied
PARNATE (tranylcypromine) tablets are available as: 10 mg: film-coated, round, rose-red and debossed with the product name PARNATE on one side and SB on the other side containing tranylcypromine sulfate ...
16.2. Storage and Handling
Store between 15° and 30°C (59° and 86°F). Dispense in a tight, light resistant container.
17. Patient Counseling Information
Advise the patient to read FDA-approved patient labeling (Medication Guide). Suicidal Thoughts and Behaviors Advise patients and caregivers to look for the emergence of suicidal thoughts and behaviors, ...