Selegiline Hydrochloride 5 mg Tablet, 60-count
🆔 Identity & classification
Where does this data come from?
🏷️ RxNorm drug class
This medicine belongs to the Monoamine Oxidase Inhibitor class.
Where does this data come from?
🏭 Manufacturer & labeler
Where does this data come from?
🩺 Clinical
- That's a really common question. Selegiline isn't meant to replace your levodopa — it's designed to make it work better. Over time, many people find their levodopa starts wearing o...
- Why am I taking selegiline if I'm already on levodopa? Isn't one medication enough?
- It is a bit different! You peel back the blister pack — don't push the tablet through the foil — and with dry hands, gently take out the tablet and immediately place it on top of y...
- How do I take the dissolving tablet? It seems different from regular pills.
Patient education
Supplement & herbal interactions
Selegiline may be associated with lower levels of 1 nutrient — worth a chat with your pharmacist, not a cause for alarm.
Where does this data come from?
Ask a licensed pharmacist directly — free, answered by our team.
💊 What it looks like
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🧪 Inactive Ingredients / Excipients
Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.
Where does this data come from?
IACT rows and label-wide narrative are kept separate; availability and product-level specificity depend on the submitted label.Inactive ingredient FAQ
Are inactive ingredients the same for every manufacturer?
Why might an inactive ingredient be missing?
Can inactive ingredients matter?
💲 Pricing
A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.
| Price system | Per ea | Per package |
|---|---|---|
| Retail pharmacies payNADAC · weekly | $0.793 | $47.56 / 60 tablets |
| Medicaid paysCMS SDUD · 12 mo | $0.9562 | $57.37 / 60 tablets |
| Medicare drug plans payPart D · Q2 2026 | $1.15 | $69.13 / 60 tablets |
Where does this data come from?
🔁 Therapeutic equivalents
| Product | Labeler | Pack | NADAC/unit | TE | Status | Price vs. this |
|---|---|---|---|---|---|---|
| Selegiline Hydrochloride 5 mg 60505-3438-03 | Apotex | 60 tablets | $0.793 | AB | Availability likely | — |
| Selegiline Hydrochloride 5 mgthis 72319-0006-02 | i3 | 60 tablets | $0.793 | AB | Availability likely | — |
| Selegiline Hydrochloride 5 mg 50090-2918-00 | A-S | 4 tablets | — | AB | FDA listed | — |
| Selegiline Hydrochloride 5 mg 60429-0176-60 | Golden | 60 tablets | — | AB | FDA listed | — |
| Selegiline Hydrochloride 5 mg 62135-0694-60 | Chartwell | 60 tablets | — | — | FDA listed | — |
| Selegiline Hydrochloride 5 mg 73141-0006-02 | A2A | 60 tablets | — | AB | FDA listed | — |
Where does this data come from?
⏳ Availability & generic status
This product is an FDA-approved generic. Other versions of the same drug are listed under Therapeutic equivalents, least expensive first.
Where does this data come from?
🗺️ Medicaid utilization & spend
🔬 Reported adverse events (FAERS)
Top reported reactions
Reporter sex
Serious outcomes
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📦 Packaging — all sizes for this product
| Package NDC | Description | Marketing start | Status |
|---|---|---|---|
| 72319-0006-02 You're viewing this | 60 TABLET in 1 BOTTLE (72319-006-02) | 2021-12-15 | Active |
📄 Full prescribing information FDA SPL
🎯 Indications and Usage ▾
INDICATIONS AND USAGE Selegiline Hydrochloride Tablets, USP are indicated as an adjunct in the management of Parkinsonian patients being treated with levodopa/carbidopa who exhibit deterioration in the quality of their response to this therapy. There is no evidence from controlled studies that selegiline has any beneficial effect in the absence of concurrent levodopa therapy. Evidence supporting this claim was obtained in randomized controlled clinical investigations that compared the effects of added selegiline or placebo in patients receiving levodopa/carbidopa.
Selegiline was significantly superior to placebo on all three principal outcome measures employed: change from baseline in daily levodopa/carbidopa dose, the amount of ‘off’ time and patient self-rating of treatment success. Beneficial effects were also observed on other measures of treatment success (e.g., measures of reduced end of dose akinesia, decreased tremor and sialorrhea, improved speech and dressing ability and improved overall disability as assessed by walking and comparison to previous state).
⏱️ Dosage and Administration ▾
DOSAGE AND ADMINISTRATION Selegiline hydrochloride tablets USP are intended for administration to Parkinsonian patients receiving levodopa/carbidopa therapy who demonstrate a deteriorating response to this treatment. The recommended regimen for the administration of Selegiline Hydrochloride Tablets USP is 10 mg per day administered as divided doses of 5 mg each taken at breakfast and lunch. There is no evidence that additional benefit will be obtained from the administration of higher doses.
Moreover, higher doses should ordinarily be avoided because of the increased risk of side effects. After two to three days of selegiline treatment, an attempt may be made to reduce the dose of levodopa/carbidopa. A reduction of 10 to 30% was achieved with the typical participant in the domestic placebo-controlled trials who was assigned to selegiline treatment.
Further reductions of levodopa/carbidopa may be possible during continued selegiline therapy.
⛔ Contraindications ▾
CONTRAINDICATIONS Selegiline hydrochloride is contraindicated in patients with a known hypersensitivity to this drug. Selegiline is contraindicated for use with meperidine. This contraindication is often extended to other opioids. (See Drug Interactions .)
⚠️ Warnings ▾
WARNINGS Selegiline should not be used at daily doses exceeding those recommended (10 mg/day) because of the risks associated with non-selective inhibition of MAO. (See CLINICAL PHARMACOLOGY .) The selectivity of selegiline for MAO-B may not be absolute even at the recommended daily dose of 10 mg a day. Rare cases of hypertensive reactions associated with ingestion of tyramine-containing foods have been reported in patients taking the recommended daily dose of selegiline.
The selectivity is further diminished with increasing daily doses. The precise dose at which selegiline becomes a non- selective inhibitor of all MAO is unknown, but may be in the range of 30 to 40 mg a day. Severe CNS toxicity associated with hyperpyrexia and death have been reported with the combination of tricyclic antidepressants and non-selective MAOIs (Phenelzine, Tranylcypromine).
A similar reaction has been reported for a patient on amitriptyline and selegiline. Another patient receiving protriptyline and selegiline developed tremors, agitation, and restlessness followed by unresponsiveness and death two weeks after selegiline was added. Related adverse events including hypertension, syncope, asystole, diaphoresis, seizures, changes in behavioral and mental status, and muscular rigidity have also been reported in some patients receiving selegiline and various tricyclic antidepressants.
Serious, sometimes fatal, reactions with signs and symptoms that may include hyperthermia, rigidity, myoclonus, autonomic instability with rapid fluctuations of the vital signs, and mental status changes that include extreme agitation progressing to delirium and coma have been reported with patients receiving a combination of fluoxetine hydrochloride and non-selective MAOIs. Similar signs have been reported in some patients on the combination of selegiline (10 mg a day) and selective serotonin reuptake inhibitors including fluoxetine, sertraline and paroxetine.
Since the mechanisms of these reactions are not fully understood, it seems prudent, in general, to avoid this combination of selegiline and tricyclic antidepressants as well as selegiline and selective serotonin reuptake inhibitors. At least 14 days should elapse between discontinuation of selegiline and initiation of treatment with a tricyclic antidepressant or selective serotonin reuptake inhibitors. Because of the long half-lives of fluoxetine and its active metabolite, at least five weeks (perhaps longer, especially if fluoxetine has been prescribed chronically and/or at higher doses) should elapse between discontinuation of fluoxetine and initiation of treatment with selegiline.
🤒 Adverse Reactions ▾
ADVERSE REACTIONS Introduction The number of patients who received selegiline in prospectively monitored pre-marketing studies is limited. While other sources of information about the use of selegiline are available (e.g., literature reports, foreign post-marketing reports, etc.) they do not provide the kind of information necessary to estimate the incidence of adverse events. Thus, overall incidence figures for adverse reactions associated with the use of selegiline cannot be provided.
Many of the adverse reactions seen have also been reported as symptoms of dopamine excess. Moreover, the importance and severity of various reactions reported often cannot be ascertained. One index of relative importance, however, is whether or not a reaction caused treatment discontinuation.
In prospective pre-marketing studies, the following events led, in decreasing order of frequency, to discontinuation of treatment with selegiline: nausea, hallucinations, confusion, depression, loss of balance, insomnia, orthostatic hypotension, increased akinetic involuntary movements, agitation, arrhythmia, bradykinesia, chorea, delusions, hypertension, new or increased angina pectoris and syncope. Events reported only once as a cause of discontinuation are ankle edema, anxiety, burning lips/mouth, constipation, drowsiness/lethargy, dystonia, excess perspiration, increased freezing, gastrointestinal bleeding, hair loss, increased tremor, nervousness, weakness and weight loss.
Experience with selegiline obtained in parallel, placebo controlled, randomized studies provides only a limited basis for estimates of adverse reaction rates. The following reactions that occurred with greater frequency among the 49 patients assigned to selegiline as compared to the 50 patients assigned to placebo in the only parallel, placebo-controlled trial performed in patients with Parkinsons disease are shown in the following Table. None of these adverse reactions led to a discontinuation of treatment. INCIDENCE OF TREATMENT-EMERGENT ADVERSE EXPERIENCES IN THE PLACEBO-CONTROLLED CLINICAL TRIAL Adverse Events Number of Patients Reporting Events Selegiline Hydrochloride placebo N = 49 N = 50 Nausea 10 3 Dizziness/Light-headed-fainting 7 1 Abdomial Pain 4 2 Confusion 3 0 Hallucinations 3 1 Dry Mouth 3 1 Vivid Dreams 2 0 Dyskinesias 2 5 Headache 2 1 The following events were reported once in either or both groups: Ache, generalized 1 0 Anxiety/Tension 1 1 Anemia 0 1 Diarrhea 1 0 Hair Loss 0 1 Insomnia 1 1 Lethargy 1 0 Leg Pain 1 0 Low back pain 1 0 Malaise 0 1 Palpitations 1 0 Uninary Retention 1 0 Weight Loss 1 0 In all prospectively monitored clinical investigations, enrolling approximately 920 patients, the following adverse events, classified by body system, were reported.
Central Nervous System Motor/Coordination/Extrapyramidal Increased tremor, chorea, loss of balance, restlessness, blepharospasm, increased bradykinesia, facial grimace, falling down, heavy leg, muscle twitch*, myoclonic jerks*, stiff neck, tardive dyskinesia, dystonic symptoms, dyskinesia, involuntary movements, freezing, festination, increased apraxia, muscle cramps. Mental Status/Behavioral/Psychiatric Hallucinations, dizziness, confusion, anxiety, depression, drowsiness, behavior/mood change, dreams/nightmares, tiredness, delusions, disorientation, lightheadedness, impaired memory*, increased energy*, transient high*, hollow feeling, lethargy/malaise, apathy, overstimulation, vertigo, personality change, sleep disturbance, restlessness, weakness, transient irritability.
Pain/Altered Sensation Headache, back pain, leg pain, tinnitus, migraine, supraorbital pain, throat burning, generalized ache, chills, numbness of toes/fingers, taste disturbance. Autonomic Nervous System Dry mouth, blurred vision, sexual dysfunction. Cardiovascular Orthostatic hypotension, hypertension, arrhythmia, palpitations, new or increased angina pectoris, hypotension, tachycardia, peripheral edema, sinus bradycardia, syncope.
Gast…
🔄 Drug Interactions ▾
Drug Interactions The occurrence of stupor, muscular rigidity, severe agitation, and elevated temperature has been reported in some patients receiving the combination of selegiline and meperidine. Symptoms usually resolve over days when the combination is discontinued. This is typical of the interaction of meperidine and MAOIs.
Other serious reactions (including severe agitation, hallucinations, and death) have been reported in patients receiving this combination (see CONTRAINDICATIONS ). Severe toxicity has also been reported in patients receiving the combination of tricyclic antidepressants and selegiline and selective serotonin reuptake inhibitors and selegiline. (See WARNING for details.) One case of hypertensive crisis has been reported in a patient taking the recommended doses of selegiline and a sympathomimetic medication (ephedrine).
🆘 Overdosage ▾
OVERDOSAGE Selegiline No specific information is available about clinically significant overdoses with selegiline hydrochloride. However, experience gained during selegiline's development reveals that some individuals exposed to doses of 600 mg of d,l-selegiline suffered severe hypotension and psychomotor agitation. Since the selective inhibition of MAO-B by selegiline hydrochloride is achieved only at doses in the range recommended for the treatment of Parkinson's disease (e.g., 10 mg/day), overdoses are likely to cause significant inhibition of both MAO-A and MAO-B.
Consequently, the signs and symptoms of overdose may resemble those observed with marketed non-selective MAO inhibitors (e.g., tranylcypromine, isocarboxazide, and phenelzine). Overdose with Non-Selective MAO Inhibition NOTE : This section is provided for reference; it does not describe events that have actually been observed with selegiline in overdose. Characteristically, signs and symptoms of non-selective MAOI overdose may not appear immediately.
Delays of up to 12 hours between ingestion of drug and the appearance of signs may occur. Importantly, the peak intensity of the syndrome may not be reached for upwards of a day following the overdose. Death has been reported following overdosage.
Therefore, immediate hospitalization, with continuous patient observation and monitoring for a period of at least two days following the ingestion of such drugs in overdose, is strongly recommended. The clinical picture of MAOI overdose varies considerably; its severity may be a function of the amount of drug consumed. The central nervous and cardiovascular systems are prominently involved.
Signs and symptoms of overdosage may include, alone or in combination, any of the following: drowsiness, dizziness, faintness, irritability, hyperactivity, agitation, severe headache, hallucinations, trismus, opisthotonus, convulsions, and coma; rapid and irregular pulse, hypertension, hypotension and vascular collapse; precordial pain, respiratory depression and failure, hyperpyrexia, diaphoresis, and cool, clammy skin. Treatment Suggestions for Overdose NOTE: Because there is no recorded experience with selegiline overdose, the following suggestions are offered based upon the assumption that selegiline overdose may be modeled by non-selective MAOI poisoning.
In any case, up-to-date information about the treatment of overdose can often be obtained from a certified Regional Poison Control Center. Telephone numbers of certified Poison Control Centers are listed in the Physicians’ Desk Reference (PDR). Treatment of overdose with non-selective MAOIs is symptomatic and supportive.
Induction of emesis or gastric lavage with instillation of charcoal slurry may be helpful in early poisoning, provided the airway has been protected against aspiration. Signs and symptoms of central nervous system stimulation, including convulsions, should be treated with diazepam, given slowly intravenously. Phenothiazine derivatives and central nervous system stimulants should be avoided.
Hypotension and vascular collapse should be treated with intravenous fluids and, if necessary, blood pressure titration with an intravenous infusion of a dilute pressor agent. It should be noted that adrenergic agents may produce a markedly increased pressor response. Respiration should be supported by appropriate measures, including management of the airway, use of supplemental oxygen, and mechanical ventilatory assistance, as required.
Body temperature should be monitored closely. Intensive management of hyperpyrexia may be required. Maintenance of fluid and electrolyte balance is essential.
🧬 Clinical Pharmacology ▾
CLINICAL PHARMACOLOGY The mechanisms accounting for selegiline’s beneficial adjunctive action in the treatment of Parkinson’s disease are not fully understood. Inhibition of monoamine oxidase, type B, activity is generally considered to be of primary importance; in addition, there is evidence that selegiline may act through other mechanisms to increase dopaminergic activity. Selegiline is best known as an irreversible inhibitor of monoamine oxidase (MAO), an intracellular enzyme associated with the outer membrane of mitochondria.
Selegiline inhibits MAO by acting as a ‘suicide’ substrate for the enzyme; that is, it is converted by MAO to an active moiety which combines irreversibly with the active site and/or the enzyme’s essential FAD cofactor. Because selegiline has greater affinity for type B rather than for type A active sites, it can serve as a selective inhibitor of MAO type B if it is administered at the recommended dose. MAOs are widely distributed throughout the body; their concentration is especially high in liver, kidney, stomach, intestinal wall, and brain.
MAOs are currently subclassified into two types, A and B, which differ in their substrate specificity and tissue distribution. In humans, intestinal MAO is predominantly type A, while most of that in brain is type B. In CNS neurons, MAO plays an important role in the catabolism of catecholamines (dopamine, norepinephrine and epinephrine) and serotonin.
MAOs are also important in the catabolism of various exogenous amines found in a variety of foods and drugs. MAO in the GI tract and liver (primarily type A), for example, is thought to provide vital protection from exogenous amines (e.g., tyramine) that have the capacity, if absorbed intact, to cause a ‘hypertensive crisis,’ the so-called ‘cheese reaction.’ (If large amounts of certain exogenous amines gain access to the systemic circulation - e.g., from fermented cheese, red wine, herring, over-the-counter cough/cold medications, etc. - they are taken up by adrenergic neurons and displace norepinephrine from storage sites within membrane bound vesicles.
Subsequent release of the displaced norepinephrine causes the rise in systemic blood pressure, etc.) In theory, since MAO-A of the gut is not inhibited, patients treated with selegiline at a dose of 10 mg a day should be able to take medications containing pharmacologically active amines and consume tyramine-containing foods without risk of uncontrolled hypertension. Although rare, a few reports of hypertensive reactions have occurred in patients receiving selegiline at the recommended dose, with tyramine-containing foods.
In addition, one case of hypertensive crisis has been reported in a patient taking the recommended dose of selegiline and a sympathomimetic medication, ephedrine. The pathophysiology of the ‘cheese reaction’ is complicated and, in addition to its ability to inhibit MAO-B selectively, selegiline's relative freedom from this reaction has been attributed to an ability to prevent tyramine and other indirect acting sympathomimetics from displacing norepinephrine from adrenergic neurons. However, until the pathophysiology of the ‘cheese reaction’ is more completely understood, it seems prudent to assume that selegiline can ordinarily only be used safely without dietary restrictions at doses where it presumably selectively inhibits MAO-B (e.g., 10 mg/day).
In short, attention to the dose dependent nature of selegiline’s selectivity is critical if it is to be used without elaborate restrictions being placed on diet and concomitant drug use although, as noted above, a few cases of hypertensive reactions have been reported at the recommended dose. (See WARNING and PRECAUTIONS .) It is important to be aware that selegiline may have pharmacological effects unrelated to MAO-B inhibition. As noted above, there is some evidence that it may increase dopaminergic activity by other mechanisms, including interfering with dopamine re-uptake at the synapse.
Effects…
📦 How Supplied / Storage and Handling ▾
HOW SUPPLIED Selegiline Hydrochloride Tablets, USP 5 mg are available for oral administration as white, unscored, round tablets debossed with “i3” on one side and “6” on the other side. They are supplied as bottle of 60 (NDC 72319-006-02). Storage Store at 20°C to 25°C (68°F to 77°F); excursions 15˚C to 30˚C (59˚F to 86˚F). [see USP Controlled Room Temperature].
Dispense in a tight, light-resistant container [see USP] with a child-resistant closure as required. i3 Pharmaceuticals, LLC SELEGILINE HYDROCHLORIDE TABLETS, USP 5 mg Manufactured by: i3 Pharmaceuticals, LLC 200 Park Ave Warminster, PA 18974 OS006-03 REV.0324 Revised: March 2024
📦 Storage and Handling ▾
Storage Store at 20°C to 25°C (68°F to 77°F); excursions 15˚C to 30˚C (59˚F to 86˚F). [see USP Controlled Room Temperature]. Dispense in a tight, light-resistant container [see USP] with a child-resistant closure as required. i3 Pharmaceuticals, LLC SELEGILINE HYDROCHLORIDE TABLETS, USP 5 mg Manufactured by: i3 Pharmaceuticals, LLC 200 Park Ave Warminster, PA 18974 OS006-03 REV.0324 Revised: March 2024
📋 Description ▾
DESCRIPTION Selegiline hydrochloride is a levorotatory acetylenic derivative of phenethylamine. It is commonly referred to in the clinical and pharmacological literature as 1-deprenyl. The chemical name is: (R)-(-)- N ,2-dimethyl- N -2-propynylphenethylamine hydrochloride.
It is a white to near white crystalline powder, freely soluble in water, chloroform, and methanol, and has a molecular weight of 223.74. The molecular formula is C 13 H 17 N•HCl. The structural formula is as follows: Each tablet, for oral administration, contains 5 mg selegiline hydrochloride.
Inactive ingredients are corn starch, lactose monohydrate, microcrystalline cellulose, povidone, and stearic acid. chemical