Wakix

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Uses of  Wakix

Wakix tablets are used to treat excessive daytime sleepiness (EDS) or cataplexy (sudden loss of muscle strength) both are symptoms of narcolepsy, which is a long-term sleep disorder.

Wakix is thought to work by increasing the amount of histamine in the area of the brain that controls sleep and wakefulness, as it acts on the histamine-3 (H3) receptor.

Narcolepsy is a disorder that affects how well the brain controls sleep-wake cycles. Often, people with narcolepsy have interrupted sleep and may feel very sleepy during the day, which interferes with their lives. Everyone who has narcolepsy has excessive daytime sleepiness, which is when they have an overwhelming sense of sleepiness that comes on quickly.

Cataplexy is when you have a sudden loss of muscle tone while you are awake, which leads to muscle weakness and loss of muscle control. Cataplexy can be mild and only last a short time, or it can be severe with a full-body collapse.

Precautions and Warnings

You should not use Wakix if you have severe liver disease or known hypersensitivity to the active ingredient pitolisant or any component of the formulation. Anaphylaxis has been reported in patients treated with this medicine.

Before taking this medicine

You should not use this medicine if you are allergic to pitolisant or any of the inactive ingredients.  The full list of ingredients is below.

You should not use Wakix if you have:

  • severe liver disease.

Tell your doctor if you have ever had:

  • liver disease;
  • kidney disease;
  • a heart rhythm disorder; or
  • long QT syndrome (in you or a family member).

Ask a doctor before using this medicine if you are pregnant or planning a pregnancy.

If you are pregnant, your name may be listed on a pregnancy registry to track the effects of this medicine on the baby.

Wakix can make hormonal birth control less effective, including birth control pills, injections, implants, skin patches, and vaginal rings. To prevent pregnancy while using this medicine, use a barrier form of birth control: condom, diaphragm, cervical cap, or contraceptive sponge. Keep using birth control for at least 21 days after your last dose of this medicine.

Ask a doctor before using this medicine if you are breastfeeding or planning to breastfeed

Dosage

The recommended dosage range for WAKIX for the treatment of EDS or cataplexy in adult patients is 17.8 mg to 35.6 mg administered orally once daily in the morning upon wakening.

Titrate dosage as follows:

  • Week 1: Initiate with a dosage of 8.9 mg nce daily
  • Week 2: Increase dosage to 17.8 mg  once daily
  • Week 3: May increase to the maximum recommended dosage of 35.6 mg once daily

Dose may be adjusted based on tolerability. If a dose is missed, patients should take the next dose the following day in the morning upon wakening. It may take up to 8 weeks for some patients to achieve a clinical response.

Side Effects

Common side effects of Wakix may include

  • nausea;
  • anxiety; or
  • sleep problems (insomnia).

Wakix may cause serious side effects.

Get emergency medical help if you have signs of an allergic reaction, such as hives, difficulty breathing, or swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have:

  • fast or pounding heartbeats;, fluttering in your chest;
  • shortness of breath; or
  • sudden dizziness (like you might pass out).

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