safinamide

Contraindicated in:

Hypersensitivity;
Concurrent use of other MAO inhibitors;
Concurrent use of opioids, SNRIs, TCAs, cyclobenzaprine, methylphenidate, amphetamine, or St. John's wort;
Concurrent use of dextromethorphan;
Severe hepatic impairment;
Psychotic disorder;
Lactation: Lactation.

Use Cautiously in:

Retinal disease;
Moderate hepatic impairment (do not exceed maximum recommended dose);
OB: Use during pregnancy only if potential maternal benefit justifies potential fetal risk;
Pedi: Safety and effectiveness not established in children.

Adv. Reactions/Side Effects ⬆ ⬇

CV: hypertension, orthostatic hypotension

EENT: visual changes

GI: ↑liver enzymes, nausea

Neuro: dyskinesia, ↑fall risk, anxiety, drowsiness, hallucinations, impulse control disorders (gambling, sexual, binge eating), insomnia, paresthesia, psychosis, sleep attacks, sleep driving

Resp: cough

Misc: hypersensitivity reactions

Interactions ⬆ ⬇

Drug-drug:

Concurrent use of other MAO inhibitors, including linezolid and isoniazid, may ↑ risk of hypertensive crises and is contraindicated; separate administration by ≥14 days.
Concurrent use of meperidine, methadone, tramadol, SSRIs, SNRIs, TCAs, cyclobenzaprine, methylphenidate, or amphetamine may ↑ risk of serotonin syndrome and is contraindicated; separate administration by ≥14 days; SSRIs may be used at the lowest dose possible.
Concurrent use with dextromethorphan may result in psychosis/bizarre behavior and is contraindicated.
Hypertensive crisis may occur with cough and cold products containing sympathomimetic amines including pseudoephedrine and phenylephrine; monitor patient's BP closely.
May ↑ levels/toxicity of imatinib, irinotecan, lapatinib, methotrexate, mitoxantrone, rosuvastatin, sulfasalazine, and topotecan; monitor closely for adverse effects.
Dopamine antagonists, including antipsychotics and metoclopramide may ↓ effectiveness of safinamide.

Drug-Natural Products:

Concurrent use with St. John's wort may ↑ risk of serotonin syndrome; concurrent use contraindicated.

Drug-Food:

Ingestion of foods containing high amounts of tyramine (>150 mg) (e.g., cheese) may result in hypertensive crisis.

Availability ⬆ ⬇

(Generic available)

Tablets: 50 mg; 100 mg

Route/Dosage ⬆ ⬇

PO (Adults ): 50 mg once daily; after 2 wk, may ↑ dose to 100 mg once daily.

Hepatic Impairment

PO (Adults ): Moderate hepatic impairment: Do not exceed 50 mg/day; Severe hepatic impairment: Contraindicated.

US Brand Names ⬆ ⬇

Action ⬆ ⬇

Irreversibly inhibits monoamine oxidase (MAO) B, which leads to ↑ dopamine levels in the CNS.

Therapeutic effects:

Increased amount of "on" time without dyskinesia or with non-troublesome dyskinesia.

Classifications ⬆ ⬇

Therapeutic Classification: antiparkinson agents

Pharmacologic Classification: monoamine oxidase type b inhibitors

Pharmacokinetics ⬆ ⬇

Absorption: 95% absorbed following oral administration.

Distribution: Extensively distributed to the tissues; readily crosses the blood-brain barrier.

Metabolism/Excretion: Extensively metabolized by hydrolytic oxidation or oxidative cleavage to inactive metabolites; 76% excreted in urine (primarily as inactive metabolites).

Half-Life: 20–26 hr.

Canadian Brand Names ⬆ ⬇

Time/Action Profile ⬆ ⬇

(plasma concentrations)

ROUTE	ONSET	PEAK	DURATION
PO	unknown	2–3 hr	24 hr

Patient/Family Teaching ⬆ ⬇

Instruct patient to take safinamide as directed. Missed doses should be omitted and next dose taken at usual time the following day. Do not double doses. Do not discontinue abruptly; may cause elevated temperature, muscular rigidity, altered consciousness, and autonomic instability. Advise patient to read Patient Information before starting therapy and with each Rx refill in case of changes.
Caution patient to avoid alcohol, CNS depressants, and foods or beverages containing tyramine (see Food Sources for Specific Nutrients) during and for at least 2 wk after therapy has been discontinued; they may precipitate a hypertensive crisis. Contact health care professional immediately if symptoms of hypertensive crisis or serotonin syndrome develop.
Instruct patient to notify health care professional of all Rx or OTC medications, vitamins, or herbal products being taken and consult health care professional before taking any new medications. Caution patient to avoid use of St. John's wort, cough or cold products containing dextromethorphan, and analgesics meperidine, tramadol, or methadone during therapy.
May cause drowsiness and unexpected episodes of falling asleep. Caution patient to avoid driving or other activities requiring alertness until response to medication is known. Advise patient to notify health care professional if episodes of falling asleep occur.
Advise patient to notify health care professional if new or increased gambling, sexual, or other impulse control disorders or psychotic-like behaviors occur.
Rep: Advise female patients to notify health care professionals if pregnancy is planned or suspected or if breastfeeding.

Pronunciation ⬆ ⬇

Code ⬆

NDC Code

27505- US WorldMeds, LLC
- 27505-110- Xadago
  - 27505-110-14- 1 BLISTER PACK in 1 CARTON (27505-110-14) > 14 TABLET, FILM COATED in 1 BLISTER PACK

27505- US WorldMeds, LLC
- 27505-110- Xadago
  - 27505-110-30- 1 BOTTLE in 1 CARTON (27505-110-30) > 30 TABLET, FILM COATED in 1 BOTTLE

27505- US WorldMeds, LLC
- 27505-110- Xadago
  - 27505-110-90- 1 BOTTLE in 1 CARTON (27505-110-90) > 90 TABLET, FILM COATED in 1 BOTTLE

27505- US WorldMeds, LLC
- 27505-111- Xadago
  - 27505-111-14- 1 BLISTER PACK in 1 CARTON (27505-111-14) > 14 TABLET, FILM COATED in 1 BLISTER PACK

27505- US WorldMeds, LLC
- 27505-111- Xadago
  - 27505-111-30- 1 BOTTLE in 1 CARTON (27505-111-30) > 30 TABLET, FILM COATED in 1 BOTTLE

27505- US WorldMeds, LLC
- 27505-111- Xadago
  - 27505-111-90- 1 BOTTLE in 1 CARTON (27505-111-90) > 90 TABLET, FILM COATED in 1 BOTTLE

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Indications ⬇

Contraind./Precautions ⬆ ⬇