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PARNATE
Overview
What is PARNATE?
Tranylcypromine sulfate, the active ingredient of PARNATE, is a non-hydrazine MAOI. The chemical name is (±)‑‑2‑phenylcyclopropylamine sulfate (2:1). The molecular formula is (CHN)•HSO and its molecular weight is 364.46. The structural formula is:
PARNATE film-coated tablets are intended for oral administration. Each round, rose‑red tablet is debossed on one side with the product name “PARNATE” and “SB” and contains tranylcypromine sulfate equivalent to 10 mg of tranylcypromine.
Inactive ingredients consist of microcrystalline cellulose, anhydrous citric acid, croscarmellose sodium, D&C Red No. 7, FD&C Blue No. 2, FD&C Yellow No. 6, gelatin, lactose, magnesium stearate, talc, titanium dioxide, carnauba wax, polyethylene glycol 400 and 8000, and hypromellose.
What does PARNATE look like?
What are the available doses of PARNATE?
Tablets: 10 mg
What should I talk to my health care provider before I take PARNATE?
How should I use PARNATE?
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 of MDD due to the potential for serious adverse reactions and drug interactions, and the need for dietary restrictions .
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 mg per day every 1 to 3 weeks to a maximum 30 mg twice daily (60 mg per day). Dosage increases should be made more gradually in patients at risk for hypotension (e.g., geriatric patients) [].
What interacts with PARNATE?
Sorry No Records found
What are the warnings of PARNATE?
Sorry No Records found
What are the precautions of PARNATE?
Sorry No Records found
What are the side effects of PARNATE?
Sorry No records found
What should I look out for while using PARNATE?
Concomitant use or use in rapid succession with other MAOIs; selective serotonin reuptake inhibitors; serotonin and norepinephrine reuptake inhibitors; tricyclic antidepressants; sympathomimetic drugs; and numerous other drugs. See Full Prescribing Information for the full list of contraindicated products (, )
Pheochromocytoma, other catecholamine-releasing paraganglioma ()
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see Warnings and Precautions (5.1)
]. PARNATE is not approved for use in pediatric patients [
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see Use in Specific Populations (8.4)
].
Hypertensive Crisis with Significant Tyramine Use
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What might happen if I take too much PARNATE?
How should I store and handle PARNATE?
Store at 20°C to 25°C (68°F to 77°F) excursions permitted from 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature]. Protect from moisture.Dispense in tight, light-resistant containers.Store at 20°C to 25°C (68°F to 77°F) excursions permitted from 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature]. Protect from moisture.Dispense in tight, light-resistant containers.PARNATE (tranylcypromine) tablets are available as:Store between 15° and 30°C (59° and 86°F). Dispense in a tight, light resistant container.PARNATE (tranylcypromine) tablets are available as:Store between 15° and 30°C (59° and 86°F). Dispense in a tight, light resistant container.
Clinical Information
Chemical Structure
No Image foundClinical Pharmacology
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) resulting from its irreversible inhibition of the enzyme monoamine oxidase (MAO).
Non-Clinical Toxicology
Concomitant use or use in rapid succession with other MAOIs; selective serotonin reuptake inhibitors; serotonin and norepinephrine reuptake inhibitors; tricyclic antidepressants; sympathomimetic drugs; and numerous other drugs. See Full Prescribing Information for the full list of contraindicated products (, )Pheochromocytoma, other catecholamine-releasing paraganglioma ()
S
Array
see Warnings and Precautions (5.1)
]. PARNATE is not approved for use in pediatric patients [
Array
see Use in Specific Populations (8.4)
].
Hypertensive Crisis with Significant Tyramine Use
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The hypoglycemic action of sulfonylureas may be potentiated by certain drugs including non-steroidal anti-inflammatory agents and other drugs that are highly protein bound, salicylates, sulfonamides, chloramphenicol, probenecid, coumarins, monoamine oxidase inhibitors, and beta-adrenergic blocking agents. When such drugs are administered to a patient receiving glyburide, the patient should be observed closely for hypoglycemia. When such drugs are withdrawn from a patient receiving glyburide, the patient should be observed closely for loss of control.
An increased risk of liver enzyme elevations was observed in patients receiving glyburide concomitantly with bosentan. Therefore concomitant administration of glyburide and bosentan is contraindicated.
Certain drugs tend to produce hyperglycemia and may lead to loss of control. These drugs include the thiazides and other diuretics, corticosteroids, phenothiazines, thyroid products, estrogens, oral contraceptives, phenytoin, nicotinic acid, sympathomimetics, calcium channel blocking drugs, and isoniazid. When such drugs are administered to a patient receiving glyburide, the patient should be closely observed for loss of control. When such drugs are withdrawn from a patient receiving glyburide, the patient should be observed closely for hypoglycemia.
A possible interaction between glyburide and ciprofloxacin, a fluoroquinolone antibiotic, has been reported, resulting in a potentiation of the hypoglycemic action of glyburide. The mechanism for this interaction is not known.
A potential interaction between oral miconazole and oral hypoglycemic agents leading to severe hypoglycemia has been reported. Whether this interaction also occurs with the intravenous, topical or vaginal preparations of miconazole is not known.
In pooled analyses of placebo-controlled trials of antidepressant drugs (SSRIs and other antidepressant classes) that included approximately 77,000 adult patients and 4,500 pediatric patients, the incidence of suicidal thoughts and behaviors in antidepressant-treated patients age 24 years and younger was greater than in placebo-treated patients. There was considerable variation in risk of suicidal thoughts and behaviors among drugs, but there was an increased risk identified in young patients for most drugs studied. There were differences in absolute risk of suicidal thoughts and behaviors across the different indications, with the highest incidence in patients with MDD. The drug-placebo differences in the number of cases of suicidal thoughts and behaviors per 1000 patients treated are provided in Table 2.
Table 2: Risk Differences of the Number of Patients of Suicidal Thoughts and Behavior in the Pooled Placebo-Controlled Trials of Antidepressants in Pediatric and Adult Patients
It is unknown whether the risk of suicidal thoughts and behaviors in children, adolescents, and young adults extends to longer-term use, i.e., beyond four months. However, there is substantial evidence from placebo-controlled maintenance trials in adults with MDD that antidepressants delay the recurrence of depression and that depression itself is a risk factor for suicidal thoughts and behaviors.
Monitor all antidepressant-treated patients for any indication for clinical worsening and emergence of suicidal thoughts and behaviors, especially during the initial few months of drug therapy, and at times of dosage changes. Counsel family members or caregivers of patients to monitor for changes in behavior and to alert the healthcare provider. Consider changing the therapeutic regimen, including possibly discontinuing PARNATE, in patients whose depression is persistently worse, or who are experiencing emergent suicidal thoughts or behaviors.
The following adverse reactions are described in greater detail in other sections:
Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. Based on clinical trial data, the most common adverse reactions to tranylcypromine were dry mouth, dizziness, insomnia, sedation, and headache (>30%) and overexcitement, constipation, blurred vision, and tremor (>10%). The following adverse reactions have been identified in clinical trials or during postapproval use of PARNATE: agranulocytosis, leukopenia, thrombocytopenia, anemia impaired water excretion compatible with the syndrome of inappropriate secretion of antidiuretic hormone (SIADH) significant anorexia, weight gain excessive stimulation/overexcitement, manic symptoms/hypomania, agitation, insomnia, anxiety, confusion, disorientation, loss of libido dizziness, restlessness/akathisia, akinesia, ataxia, myoclonic jerks, tremor, hyper-reflexia, muscle spasm, paresthesia, numbness, memory loss, sedation, drowsiness, dysgeusia, headaches (without blood pressure elevation) blurred vision, nystagmus tinnitus tachycardia, palpitations hypertensive crisis, hypertension, hypotension (including postural hypotension with syncope) diarrhea, constipation, nausea, abdominal pain, dry mouth, fissuring in corner of mouth hepatitis, elevated aminotransferases localized scleroderma, flare-up of cystic acne, urticaria, rash, alopecia, sweating urinary retention, urinary incontinence, urinary frequency impotence, delayed ejaculation edema, chills, weakness, fatigue/lethargy
Reference
This information is obtained from the National Institute of Health's Standard Packaging Label drug database.
"https://dailymed.nlm.nih.gov/dailymed/"
While we update our database periodically, we cannot guarantee it is always updated to the latest version.
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