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Safinamide

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Molecule Summary

Uses
Parkinson's disease
Therapy
Anti-Parkinsonian
Side Effects
Insomnia, dizziness, headache, cataract
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Molecule Description

Safinamide is a medicine used to treat adults with idiopathic Parkinson's disease. It is usually prescribed along with other Parkinson's medicines, such as levodopa, to help improve movement-related symptoms like stiffness, slowness, and tremors, and to reduce "off" periods when symptoms return between doses. Improving movement control can help patients perform daily activities more comfortably. This medicine works by increasing the level of dopamine in the brain. It does so by selectively inhibiting monoamine oxidase B (MAO-B), which normally degrades dopamine. By preventing dopamine breakdown, Safinamide prolongs its action and enhances its efficacy, supporting smoother, better-controlled movements. Safinamide should be taken exactly as advised by the doctor. It is usually taken with water and is best taken with or after food to reduce stomach-related side effects. Taking it at the same time each day helps maintain consistent benefits, and the prescribed dose should not be exceeded. Certain precautions are important while using this medicine. Patients should inform their doctor about all other medicines they are taking, especially antidepressants, pain medicines, or drugs that affect brain chemicals, as interactions may occur. Extra caution is needed in individuals with liver disease or a history of eye or retinal disease, as the medication may not be suitable in these cases. Some patients may notice side effects such as increased involuntary movements when taken with levodopa, or unusual behavior changes like impulsive actions or strong urges. Caregivers should also be aware of these possible changes. Safinamide is generally not recommended during pregnancy or breastfeeding unless clearly advised by a doctor, due to limited safety information.

Uses

Safinamide is used to treat adult patients with idiopathic Parkinson's disease (PD).

Contraindications

When should one not use Safinamide

  • If you are allergic to Safinamide or any ingredients of Safinamide.
  • If you are taking other medicines called monoamine oxidase (MAO) inhibitors.
  • If you are using pethidine for pain relief.
  • If you have severe liver disease.
  • If you have certain eye conditions such as albinism, retinal degeneration, uveitis, inherited retinal disorders, or severe progressive diabetic eye disease.

Side effects

Common side effects of this drug are:

  • Insomnia
  • Dizziness
  • Headache
  • Cataract

Precautions and Warnings

Pregnancy

Pregnancy

Safinamide is not recommended during pregnancy, as there is limited information on its use in pregnant women, and animal studies have shown potential harm to the developing baby. Women who can become pregnant should use effective contraception while taking this medicine. Always consult your doctor before using it.

Breast Feeding

Breast Feeding

Safinamide should not be used while breastfeeding, as animal studies show that the medicine passes into breast milk and may pose a risk to the breastfed baby. Always consult your doctor before using it.

Driving

Driving

Safinamide may cause drowsiness or dizziness in some people. You should avoid driving or operating machinery until you know how this medicine affects you and are sure it does not impair your alertness.

Alcohol

Alcohol

No specific information is available. As alcohol may increase dizziness or drowsiness, limit alcohol and consult your doctor.

Other General Warnings

Other General Warnings

Talk to your doctor if
  • You are taking antidepressants like SSRIs, especially fluoxetine or fluvoxamine, as using them together with safinamide may increase the risk of serotonin-related side effects.
  • You have recently stopped, or plan to start, medications such as MAO inhibitors or pain medications like pethidine, as a gap of at least 7 days is required.
  • You are taking other medications that may interact with safinamide; dose adjustments or monitoring may be required.
  • You have liver problems, especially moderate liver disease, as safinamide may need caution or may have to be stopped if liver function worsens.
  • You have a history of eye or retinal problems, such as hereditary retinal disease or uveitis, as safinamide may not be suitable for you.
  • You or your caregiver notices unusual behavior changes such as compulsive spending, gambling, increased sexual urges, or impulsive actions.
  • You experience worsening involuntary movements (dyskinesia) while taking safinamide with levodopa, as your levodopa dose may need adjustment.

Mode of Action

How Does It Work?

Safinamide works by selectively inhibiting monoamine oxidase B (MAO-B), an enzyme that breaks down dopamine in the brain. By preventing dopamine breakdown, it increases and prolongs dopamine action, helping improve movement control in people with Parkinson's disease.

Interactions

Interactions with other medicines

  • Do not take Safinamide if you are using other MAO inhibitors (such as moclobemide), as this combination can cause a dangerous rise in blood pressure.
  • Do not use Safinamide together with pethidine, as this can lead to serious and harmful reactions.
  • Be careful when using cold, cough, or nasal decongestant medicines (such as those containing ephedrine or pseudoephedrine), as taking them with Safinamide may increase the risk of side effects.
  • Avoid using cough medicines containing dextromethorphan with Safinamide, or use them only with caution if absolutely necessary.
  • Avoid taking certain antidepressants like fluoxetine or fluvoxamine with Safinamide, as this may increase the risk of serious reactions such as serotonin syndrome.
  • If antidepressants are needed, they should be used at the lowest effective dose and with careful monitoring.
  • A gap (washout period) may be needed between stopping some antidepressants and starting Safinamide to reduce the risk of side effects.
  • Inform your doctor if you are taking medicines for depression, anxiety, or mood disorders, including SSRIs, SNRIs, or tricyclic antidepressants.
  • Safinamide may slightly increase plasma concentrations of certain medications, including rosuvastatin and related drugs, warranting monitoring.
  • Extra caution is needed if you take medications such as metformin, aciclovir, or ganciclovir, as Safinamide may increase their plasma concentrations.
  • Tell your doctor if you are taking medications such as ciprofloxacin, methotrexate, or diclofenac, or diabetes medications such as glyburide, as dose adjustment or monitoring may be required.
  • Always inform your doctor about all prescription medicines, over-the-counter drugs, and herbal products you are using before starting Safinamide.

Interactions with food items

  • Safinamide can be taken with or without food.
  • No strict food restrictions are usually needed.
  • Avoid excessive consumption of aged or fermented foods.
  • Limit alcohol to reduce dizziness or drowsiness.

Dosage

Overdose

If you think you have taken too much of this medicine, contact your doctor immediately or visit the nearest hospital.

Missed a Dose

If you miss any dose of Safinamide, take it as soon as you remember with food. However, if it is almost time for the next dose, then skip the missed dose and resume your usual dosing schedule. Do not double the dose to catch up.

Frequently Asked Questions (FAQs)

Safinamide is used in people with Parkinson's disease, along with levodopa, to improve motor symptoms such as stiffness, slowness, and tremor, and to reduce "off" periods.

Safinamide is generally not recommended during pregnancy or breastfeeding unless clearly advised by a doctor, as there is limited safety information available.

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