Xygarot Oral Solution – Patent Information Leaflet

Xygarot oral solution contains escitalopram oxalate equivalent to 1 mg/mL escitalopram base. For more information- Click Here to read Xygarot Oral Solution – Patient Information Leaflet.

INDICATIONS AND USAGE

Major Depressive Disorder: Xygarot (escitalopram) is indicated for the treatment of major depressive disorder. A major depressive episode (DSM-IV) implies a prominent and relatively persistent (nearly every day for at least 2 weeks) depressed or dysphoric mood that usually interferes with daily functioning, and includes at least five of the following nine symptoms: depressed mood, loss of interest in usual activities, significant change in weight and/or appetite, insomnia or hypersomnia, psychomotor agitation or retardation, increased fatigue, feelings of guilt or worthlessness, slowed thinking or impaired concentration, a suicide attempt or suicidal ideation.

Xygarot is indicated for the treatment of Generalized Anxiety Disorder (GAD). Generalized Anxiety Disorder (DSM-IV) is characterized by excessive anxiety and worry

(apprehensive expectation) that is persistent for at least 6 months and which the person finds difficult to control. It must be associated with at least 3 of the following symptoms: restlessness or feeling keyed up or on edge, being easily fatigued, difficulty concentrating or mind going blank, irritability,muscle tension, and sleep disturbance. 

Treatment of major depressive episodes.

Xygarot, may also indicated in:

What Are Side Effects of Xygarot?

Common side effects of Xygarot include:

General Instructions

  • Don’t suddenly stop taking Xygarot (escitalopram). Talk to your healthcare provider about how to slowly lower your dose to avoid withdrawal symptoms.
  • Tell your provider if you notice sudden mood changes or unusual thoughts.
  • Like other SSRI medications, it could take up to 12 weeks to see the full effects of Xygarot (escitalopram) on your mood.
  • If you have trouble sleeping while taking Xygarot (escitalopram) it can help to take it in the morning.
  • Tell your healthcare providers all the medications you’re taking prior to starting Xygarot (escitalopram) so they can check for interactions. For more information- Click Here to read Xygarot Oral Solution – Patient Information Leaflet.

Warnings – Precautions

Xygarot (escitalopram) can cause some serious health issues. This risk may be even higher for certain groups. If this worries you, talk to your doctor or pharmacist about other options

SUICIDAL THOUGHTS AND BEHAVIOR : Xygarot (escitalopram) can raise the risk of suicidal thoughts or behavior. Watch for new or worsening depression, suicidal thoughts or behavior, especially during the first few months of treatment or when the dose changes. Let your healthcare provider know immediately if you notice any unusual changes in mood or behavior while taking this medication.

SEROTONIN SYNDROME: Serotonin syndrome is a rare, but potentially life-threatening condition where there’s too much serotonin active in the brain. (Serotonin is one of the chemicals in your brain responsible for your mood.) Your risk goes up if you use Xygarot (escitalopram) with other medications that affect serotonin levels (antidepressants, lithium, triptans, St. John’s wort). Symptoms of too much serotonin include fast heart rate, sweating, muscle stiffness or spasms, fever, and confusion. Tell your healthcare provider or seek medical help right away if you have any of these symptoms.

WITHDRAWAL: Stopping Xygarot (escitalopram) suddenly can cause withdrawal symptoms such as nausea, anxiety, agitation, flu-like symptoms, trouble sleeping, and dizziness. Withdrawal symptoms usually start within 3 days of stopping the medication. Talk to your healthcare provider to figure out how to slowly and safely cut down on your medication.

HIGHER BLEEDING RISK: Risk factors: Taking other blood-thinning drugs (including aspirin, NSAIDs such as Advil, or warfarin) Xygarot (escitalopram) can increase the risk of bleeding or bruising, especially if you’re also taking aspirin, NSAIDs (like Advil), or blood thinners. The bleeding can be life-threatening. Tell your healthcare provider about any bruising that doesn’t improve, black-colored stools, pink or red urine, or unusual bleeding from the nose or gums. If you’re on blood thinners, the provider might have to change your dose.

ABNORMAL HEART RHYTHM: Xygarot (escitalopram) can affect the natural rhythm of your heart and cause it to beat abnormally. If you experience symptoms such as fast heart rate, dizziness, difficulty breathing or chest pain, go to the emergency room right away. If you’ve had heart problems in the past, talk to your healthcare provider first to make sure Xygarot (escitalopram) is safe for you to take.

LOW SODIUM LEVELS IN THE BLOOD: Xygarot (escitalopram) can cause very low sodium levels in your blood. Tell your healthcare provider right away if you experience weakness, confusion, difficulty concentrating, headache or memory problems.

MANIA: Treating someone with bipolar disorder with an antidepressant alone can cause a manic episode (great excitement, euphoria, delusions and overactivity). This is more likely to happen if you or someone in your family has had bipolar disorder. Your provider should make sure that you don’t have bipolar disorder before starting Xygarot (escitalopram). Talk to your provider right away if you notice unusual changes in your behavior. 

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Multi-Apex for Pharmaceutical Industries – Egypt

Xygarot – Patient Information Leaflet

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Xygarot- Arabic Information

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