Selegiline is a monoamine oxidase inhibitor sold in the U.S. under 3 brand and generic names, for alzheimer disease, attention deficit disorder with hyperactivity and depressive disorder. Below: what the FDA label says, every product that contains it, what the pills look like, and its recall record.
From the FDA label for Eldepryl (application NDA020647). Other selegiline products — different forms, different strengths — are dosed differently. Follow the label for the one you were prescribed.
Initiate treatment with 1.25 mg given once a day for at least 6 weeks; after 6 weeks, the dose may be escalated to 2.5 mg once a day ( 2.1 ) • Place tablet on top of the tongue where the tablet will disintegrate in seconds; avoid food and liquid intake 5 minutes before and after each dose ( 2.1 ) • In patients with mild or moderate hepatic impairment, the dose should be reduced to 1.25 mg; ZELAPAR is not recommended in patients with severe (Child-Pugh score >9) hepatic impairment ( 2.2 ) 2.1 General Dosage Recommendations Initiate treatment with 1.25 mg given once a day for at least 6 weeks. After 6 weeks, the dose may be increased to 2.5 mg given once a day if a desired benefit has not been achieved and the patient is tolerating ZELAPAR. There is no evidence that doses greater than 2.5 mg a day provide additional benefit, and they should ordinarily be avoided because of the potential increased risk of adverse events. Take ZELAPAR in the morning before breakfast and without liquid. Patients should avoid ingesting food or liquids for 5 minutes before and after taking ZELAPAR. Patients should not attempt to push ZELAPAR through the foil backing. Patients should PEEL BACK the backing of one or two blisters (as prescribed) with dry hands, and GENTLY remove the tablet(s). Patients should IMMEDIATELY place the ZELAPAR tablet(s) on top of the tongue…
The following adverse reactions are discussed in more detail in the Warnings and Precautions section of labeling: • Risk for Hypertension [see Warnings and Precautions (5.1) ] • Risk of Serotonin Syndrome [see Warnings and Precautions (5.2) ] • Falling Asleep During Activities of Daily Living and Somnolence [see Warnings and Precautions (5.3) ] • Hypotension/Orthostatic Hypotension [see Warnings and Precautions (5.4) ] • Dyskinesia [see Warnings and Precautions (5.5) ] • Hallucinations/Psychotic-Like Behavior [see Warnings and Precautions (5.6) ] • Impulse Control/Compulsive Behaviors [see Warnings and Precautions (5.7) ] • Withdrawal Emergent Hyperpyrexia and Confusion [see Warnings and Precautions (5.8) ] • Irritation of the Buccal Mucosa [see Warnings and Precautions (5.9) ] • Risk for Patients with Phenylketonuria [see Warnings and Precautions (5.10) ] The most common adverse reactions (incidence at least 3% greater than on placebo) are constipation, skin disorders, vomiting, dizziness, dyskinesia, insomnia, dyspnea, myalgia, and rash (6.1) To report SUSPECTED ADVERSE REACTIONS, contact Bausch Health US, LLC at 1-800-321-4576 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, the incidence of adverse reactions (number of unique patients experiencing an adverse reaction per…
Tyramine-rich foods
Follow the specific food list your prescriber gives you and avoid high-tyramine foods while taking an MAOI (and for a period after stopping). Seek urgent care for a sudden severe headache.
Phenelzine (an MAOI) — MedlinePlus (U.S. National Library of Medicine) ↗Same active ingredient — different manufacturer, form, price and FDA recall record. That last one is what our independent score measures.
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| 1 | Not yet rated | Prescription | Capsule | Generic | $19 | View → | |
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Imprint codes, colour and shape from the FDA’s labelling data. Match the imprint on your pill — or search any imprint.
| Imprint | Strength | Colour | Shape | Maker |
|---|---|---|---|---|
| Novitium5mg;504 | 5 mg | white | capsule | — |
| Novitium5mg;504 | 5 mg | white | capsule | — |
| A;3438 | 5 mg | white | round | — |
| APO;055 | 5 mg | white, blue | capsule | — |
| A;3438 | 5 mg | white | round | — |
Sources: FDA openFDA drug label, National Drug Code Directory, and Enforcement (recall) database. This page reproduces public FDA data and is not medical advice. Dosing is set by your prescriber.
ZELAPAR is contraindicated in patients with: • Concomitant use of opioid drugs (e.g., meperidine, tramadol, or methadone). Serotonin syndrome, a potentially serious condition, which can result in death, has been reported with concomitant use of meperidine (e.g., Demerol and other trade names). At least 14 days should elapse between discontinuation of ZELAPAR and initiation of treatment with these medications [see Warnings and Precautions (5.2) ] . • Concomitant use of other drugs in the monoamine oxidase inhibitor (MAOI) class or other drugs that are potent inhibitors of monoamine oxidase, including linezolid), because of an increased risk for hypertensive crisis [see Warnings and Precautions (5.1)]. At least 14 days should elapse between discontinuation of ZELAPAR and initiation of treatment with any MAO inhibitor. • Concomitant use of St. John’s wort or cyclobenzaprine (a tricyclic muscle relaxant). • Concomitant use of dextromethorphan, because of reported episodes of psychosis or bizarre behavior. ZELAPAR is contraindicated in patients using the following drugs: opioid drugs (e.g., meperidine, tramadol, methadone), MAO inhibitors including selective MAO-B inhibitors, dextromethorphan, St. John’s wort, and cyclobenzaprine ( 4 )
Opioid Drugs Because serious, sometimes fatal reactions have been precipitated with concomitant use of opioid drugs (e.g., meperidine and its derivatives, methadone, or tramadol) and MAOIs, including selective MAO-B inhibitors, concomitant use of these drugs with ZELAPAR is contraindicated [see Contraindications ( 4 ) and Warnings and Precautions ( 5.2 )] . At least 14 days should elapse between discontinuation of ZELAPAR and initiation of treatment with these drugs. 7.2 Dextromethorphan The combination of MAO inhibitors and dextromethorphan has been reported to cause brief episodes of psychosis or bizarre behavior. Therefore, in view of ZELAPAR’s MAO inhibitory activity, dextromethorphan should not be used concomitantly with ZELAPAR [see Contraindications (4) ] . 7.3 MAO Inhibitors ZELAPAR is contraindicated for concomitant use with other drugs in the MAOI class or other drugs that are potent inhibitors of monoamine oxidase (including linezolid, an oxazolidinone antibacterial, which also has reversible nonselective MAO inhibition activity) because of the increased risk for hypertensive crisis [see Contraindications (4) and Warnings and Precautions (5.1 )] . At least 14 days should elapse between discontinuation of ZELAPAR and initiation of treatment with other MAOIs. 7.4 Sympathomimetic Medications Uncontrolled hypertension, including hypertensive crisis, has been reported…
| Prescription |
| Patch |
| Generic |
| $19 |
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| 3 | Not yet rated | Prescription | Tablet | Generic | $19 | View → |