Using Fleqsuvy correctly is important to get the best results and avoid problems.

• Shake the bottle well before each use. The medicine might settle at the bottom, and shaking mixes it evenly.

   

• Use the dosing syringe that comes with the bottle to measure the correct amount. Avoid using regular spoons.

   

• Take the medicine by mouth, slowly swallowing the dose. If you have a feeding tube, your healthcare provider will give you special instructions.

   

• Fleqsuvy is usually taken 3 to 4 times a day, depending on your doctor’s prescription.

   

• Store the bottle at room temperature, away from heat and moisture.

   

Once you open the bottle, you should use it within 2 months and then discard any leftover medicine.

The active ingredient in Fleqsuvy is baclofen. Baclofen works on the nervous system, especially the spinal cord. Our brain sends messages to muscles through nerves, telling them when to move or stay still. In spasticity, these messages become too strong or happen too often, making muscles tighten or spasm uncontrollably.

Baclofen works by calming down some of these nerve signals. It acts like a messenger that tells nerves to slow down the signals causing muscle tightness. By doing this, baclofen helps muscles relax, reduces stiffness, and decreases painful spasms. This allows people to move more easily and comfortably.

Like all medicines, Fleqsuvy can cause side effects. Some are common and mild, while others are rare but more serious.

Common side effects include:

• Feeling sleepy or tired

   

• Dizziness or feeling lightheaded

   

• Weakness in muscles

   

• Nausea or upset stomach

   

• Headache

   

• Confusion or difficulty concentrating

   

• Trouble sleeping

   

• Constipation

   

• Increased need to urinate

   

Most side effects improve over time as your body gets used to the medicine. However, if side effects are severe or do not go away, you should talk to your doctor.

Serious side effects are rare but may happen, especially if the medicine is stopped suddenly. These include:

• Hallucinations (seeing or hearing things that are not there)

   

• Seizures

   

• High fever

   

• Muscle stiffness or pain worsening

   

If you experience these serious symptoms, seek emergency medical help immediately.

Before using Fleqsuvy, you should inform your doctor about any health problems you have. This helps the doctor decide if Fleqsuvy is safe for you.

Important warnings include:

• Do not stop Fleqsuvy suddenly. Stopping quickly can cause withdrawal symptoms like hallucinations or seizures.

   

• Avoid alcohol and sedatives while taking Fleqsuvy because combining them increases drowsiness and can be dangerous.

   

• If you have kidney problems, tell your doctor. The medicine is removed from the body through the kidneys, so dose adjustments may be needed.

   

• Tell your doctor if you have a history of mental illness, seizures, or stroke.

   

• Pregnant or breastfeeding women should discuss the risks and benefits with their healthcare provider.

   

• Use caution if you need to operate machinery or drive, as Fleqsuvy can cause drowsiness or dizziness.

   

It is important to use the measuring syringe that comes with the medicine bottle to get the right dose. Do not use regular spoons because they are not accurate.

Fleqsuvy can interact with other medicines. It is especially important to be careful if you are taking other drugs that make you sleepy or slow your brain activity, such as sleeping pills, sedatives, or alcohol. Taking Fleqsuvy with these medicines can cause too much drowsiness or dizziness.

Always tell your doctor about all the medicines and supplements you are taking before starting Fleqsuvy.

Here is a general guideline for Fleqsuvy dosing. Remember, your doctor will give you the exact dose you need.

• Starting dose: 5 mg (1 mL) three times a day for 3 days.

   

• Increasing dose: Your doctor may increase the dose by 5 mg every 3 days, depending on your response.

   

• Maintenance dose: Many patients find relief at doses between 30 mg to 80 mg per day, divided into 3 or 4 doses.

   

• Maximum dose: Should not exceed 80 mg daily.

   

Your doctor will adjust your dose carefully to get the best balance between effectiveness and side effects.

If you miss a dose, take it as soon as you remember unless it is almost time for your next dose. Do not take two doses at the same time.

Fleqsuvy is a prescription medicine. This means you cannot buy it over-the-counter and must have a doctor’s prescription.

The doctor will evaluate your condition and decide if Fleqsuvy is suitable for you. They will also monitor your progress regularly to adjust the dose or change treatment if needed.

Because baclofen affects the nervous system and has risks if stopped suddenly, it is important to use Fleqsuvy only under medical supervision.

• What is Fleqsuvy used for?
  It is used to treat spasticity (muscle stiffness, spasms, and pain) caused by conditions such as multiple sclerosis (MS), spinal cord injuries, or neurological diseases.
  It helps improve mobility and reduce muscle tightness.

• What is the brand name?
  Fleqsuvy® — manufactured by Azurity Pharmaceuticals, Inc.

• What is the active ingredient?
  Baclofen, a GABA-B receptor agonist (skeletal muscle relaxant).

• How does Fleqsuvy work?

  • Acts on nerve cells in the spinal cord to inhibit signals that cause muscle spasms.

  • Reduces muscle rigidity and pain by suppressing reflex activity.

• What type of medication is it?
  A skeletal muscle relaxant / antispastic agent.

• How is Fleqsuvy administered?

  • By mouth, as a liquid oral suspension.

  • Concentration: 25 mg per 5 mL (5 mg/mL).

  • Shake well before each use.

  • Measure the dose using the provided oral dosing syringe — do not use household spoons.

  • The dose is started low and gradually increased based on tolerance and response.

• What are the available strengths and forms?

  • Oral suspension: 25 mg per 5 mL.

  • Supplied in bottles of 120 mL or 300 mL.

• How long does it take to work?

  • Some improvement may appear within a few days, with maximum effect after 1–2 weeks of regular dosing.

• What are the common side effects?

  • Drowsiness or dizziness

  • Weakness or fatigue

  • Nausea

  • Confusion

  • Headache

  • Insomnia or urinary frequency

• Are there serious side effects?
  Yes, although rare:

  • Severe withdrawal reactions (if stopped suddenly): hallucinations, seizures, fever, or muscle rigidity

  • Severe drowsiness or respiratory depression (especially with alcohol or sedatives)

  • Worsening of psychiatric or seizure disorders

  • Kidney dysfunction in susceptible patients

• Who should not take Fleqsuvy?

  • Individuals allergic to baclofen

  • Patients with severe kidney impairment (dose adjustment or avoidance may be required)

  • Use caution in those with stroke, epilepsy, or mental health disorders

• Can it be used in children?
  Safety has not been established in children under 12 years of age.

• Can it be used during pregnancy?
  Use only if clearly needed — baclofen crosses the placenta.
  Newborn withdrawal symptoms have been reported when mothers used baclofen during pregnancy.

• Can it be used while breastfeeding?
  Use with caution — baclofen passes into breast milk in small amounts.

• Does Fleqsuvy interact with other medications?
  Yes, major interactions include:

  • Alcohol, opioids, and sedatives — may increase drowsiness and risk of respiratory depression.

  • Other muscle relaxants or CNS depressants — additive effects possible.

  • Kidney-acting drugs (e.g., NSAIDs) — may affect baclofen clearance.

• How should I store Fleqsuvy?

  • Store at room temperature (68–77°F / 20–25°C).

  • Keep tightly closed and away from heat or sunlight.

  • Discard any unused portion 2 months after opening.

• Is there a generic available?

  • Baclofen tablets are available generically.

  • Fleqsuvy® is a brand-only oral suspension formulation.

• Where can I get it?
  Available by prescription only, dispensed through pharmacies or specialty providers.