Safinamide

How does Safinamide work?

Safinamide works by increasing dopamine levels in the brain and modulating glutamate activity, both of which are important for controlling movement. It is a monoamine oxidase-B (MAO-B) inhibitor that helps prevent the breakdown of dopamine, improving motor control in people with Parkinson's disease. It also has NMDA receptor antagonism properties, which helps balance excitatory signals in the brain, further aiding in the reduction of motor fluctuations.

Is Safinamide effective?

Safinamide has been proven effective in clinical trials for treating Parkinson’s disease, particularly in improving motor function and controlling symptoms like tremors and rigidity. Studies have shown that when added to a stable dose of levodopa, it improves the overall motor response, reduces “off” times (periods when symptoms worsen), and provides better control of symptoms. It works as both a monoamine oxidase-B inhibitor and a glutamate release modulator.

What is Safinamide?

Safinamide is primarily used to treat Parkinson's disease, often in combination with other medications like levodopa. It works by inhibiting monoamine oxidase B (MAO-B), which breaks down dopamine in the brain, and modulating glutamate release. This helps to improve motor function and reduce symptoms of Parkinson's, such as tremors and rigidity.

For how long do I take Safinamide?

The typical duration of use for safinamide in treating Parkinson's disease is often assessed in clinical studies lasting 24 to 52 weeks. In these studies, patients are monitored for efficacy and safety, with some participants continuing in open-label extensions beyond the initial study period. Long-term use may be considered based on individual patient response and tolerability.

How do I dispose of Safinamide?

If you can, bring unused medicines to a drug take-back program or collection site at a pharmacy or hospital. They will dispose of this medicine properly so they don't harm people or the environment. If you can't find a take-back program, you can throw most medicines in the trash at home. But first, take them out of their original containers, mix them with something undesirable like used coffee grounds, seal the mixture in a plastic bag and throw it away.

How do I take Safinamide?

Safinamide can be taken with or without food, and there are no specific food restrictions. However, it is important to take the medication as prescribed, and the tablet should be swallowed whole without crushing or chewing. For optimal effectiveness, it should be taken consistently at the same time each day.

How long does it take for Safinamide to start working?

Safinamide may take several weeks to show noticeable benefits in patients with Parkinson's disease, as it works gradually to improve motor function. However, the time it takes to experience significant effects can vary depending on the individual and their response to the medication. It's important to follow the prescribed dosing schedule for optimal results.

How should I store Safinamide?

Store at room temperature between 68°F and 77°F (20°C and 25°C).

Keep the bottle tightly closed.

Keep out of the reach of children.

Protect from moisture.

It is important to follow these storage instructions to ensure that the medication remains effective and safe for use.

What is the usual dose of Safinamide?

The usual daily dose of safinamide for adults is:

• Initial Dose: 50 mg orally once a day.
• Maintenance Dose: After 2 weeks, the dose may be increased to 100 mg once a day based on individual needs and tolerability.
• Maximum Dose: 100 mg per day.

For children, the use and dosage must be determined by a healthcare provider, as specific dosing guidelines for pediatric patients are not established.

Can I take Safinamide with other prescription drugs?

Safinamide interacts with dopaminergic medications like levodopa, potentially increasing side effects like dyskinesia. It should not be combined with MAO inhibitors (e.g., selegiline) due to the risk of hypertensive crises or serotonin syndrome. Interactions with antidepressants (SSRIs, SNRIs) and antipsychotics can also increase the risk of serotonin syndrome or reduce effectiveness. Always consult a healthcare provider.

Can Safinamide be taken safely while breastfeeding?

There is limited information on the safety of Safinamide during breastfeeding. It is not known whether Safinamide passes into breast milk, but due to its potential effects on the nervous system, caution is recommended. The drug should be used during lactation only if the benefits outweigh the potential risks, and a healthcare provider should be consulted.

Can Safinamide be taken safely while pregnant?

Safinamide is classified as a Category C drug for pregnancy, meaning that there is limited evidence of potential risks to the fetus. Animal studies have shown some harmful effects, but no adequate studies in humans are available. It should only be used during pregnancy if the potential benefit justifies the potential risk to the fetus. Always consult a healthcare provider before use.

Does Safinamide have adverse effects?

Adverse effects, which are unwanted or harmful reactions to a medicine, can occur with any medication. For this medicine, common adverse effects might include nausea, headache, dizziness, fatigue, and dry mouth. These effects can vary in how often they occur, but they are generally not severe. However, there are rare but serious adverse effects that require immediate medical attention, such as difficulty breathing, severe rash, or swelling of the face and throat. It's crucial to report any new or worsening symptoms to a healthcare provider. Never stop taking a medicine without consulting a healthcare professional, as they can provide guidance on managing side effects or adjusting treatment.

Does Safinamide have any safety warnings?

To determine if a medicine has safety warnings, you should first check the prescription information provided with the medicine. This information often includes a section on safety warnings. For example, if the medicine is known to cause drowsiness, the warning might advise against driving or operating heavy machinery. The rationale is to prevent accidents due to impaired alertness. Possible consequences of ignoring this warning include car accidents or workplace injuries. Symptoms to monitor include feeling unusually sleepy or having trouble staying awake. Another common warning might be about allergic reactions, which can be serious. The rationale is to prevent severe health issues like anaphylaxis, which is a life-threatening allergic reaction. Signs to watch for include rash, itching, swelling, severe dizziness, or trouble breathing. Always read the safety warnings carefully and consult your healthcare provider if you have any concerns.

Is it safe to drink alcohol while taking Safinamide?

It's best to avoid alcohol while using Safinamide, as it may increase side effects like drowsiness and dizziness. Check with your doctor for personal recommendations.

Is it safe to exercise while taking Safinamide?

Exercise is generally safe with Safinamide, but be cautious if you experience dizziness, drowsiness, or muscle issues. Start with light activities and consult your doctor if these symptoms occur.

Is it safe to stop Safinamide?

To determine if it's safe to stop a medicine, first identify its purpose. If it's for managing a chronic condition like hypertension or diabetes, stopping it suddenly can lead to serious health risks, such as uncontrolled blood pressure or blood sugar levels. If the medicine is for symptomatic relief or treating a temporary condition, like an infection, stopping it might lead to a return of symptoms or incomplete treatment. Some medicines can cause withdrawal or rebound symptoms if stopped abruptly, which can be uncomfortable or dangerous. In some cases, stopping a medicine suddenly can lead to life-threatening complications. Therefore, it's crucial to consult with a doctor before stopping any medicine. They can provide guidance on how to safely discontinue the medicine, if appropriate, and discuss any potential risks involved.

Is Safinamide addictive?

This medicine does not have any known potential for dependence or addiction. It is considered safe in terms of habit-forming properties. Therefore, there is no need to worry about physical or psychological dependence when using this medication as prescribed. Always follow the dosage instructions provided by your healthcare provider to ensure safe use. If you have any concerns or questions about this medicine, it is best to discuss them with your doctor or pharmacist.

Is Safinamide safe for the elderly?

• Safety Profile: Safinamide is considered safe as an adjunct therapy for Parkinson's disease in patients aged 75 and older, with a consensus among experts regarding its use in this population.
• Dosing: Initial dosing should follow standard guidelines, but careful monitoring is advised due to potential increased sensitivity to side effects.
• Cognitive Impairment: Safinamide can be used in patients with cognitive impairment, though monitoring for any adverse effects is recommended.
• Adverse Events: While generally well tolerated, adverse events may occur, necessitating regular assessment of the patient's condition and medication efficacy.

What are the most common side effects of Safinamide?

A side effect is an unwanted or unexpected symptom caused by a medicine. For this medicine, common side effects may include nausea, which is feeling sick to your stomach, dizziness, which is feeling lightheaded or unsteady, headache, which is pain in the head, fatigue, which is feeling very tired, and dry mouth, which is a lack of saliva. The frequency of these side effects can vary, but they are generally considered common. It's important to note that when starting a new medicine, people might experience new symptoms that could be coincidental, unrelated, or temporary. These symptoms might also be due to another health issue. Always talk to a healthcare provider before stopping any medicine, as they can provide guidance on managing side effects and ensure your treatment is safe and effective.

Who should avoid taking Safinamide?

Safinamide should be used with caution in patients with a history of mental health disorders, such as depression, as it may exacerbate mood changes or lead to suicidal thoughts. It is contraindicated in individuals with hypersensitivity to Safinamide or any of its components, severe hepatic impairment, or those taking certain other medications, such as monoamine oxidase inhibitors (MAOIs). Regular monitoring is recommended for those with a history of cardiovascular issues.