Lexapro

Lexapro Special Precautions

escitalopram

Manufacturer:

Lundbeck

Distributor:

Metro Drug
Full Prescribing Info
Special Precautions
The following precautions apply to the therapeutic class of selective serotonin re-uptake inhibitors (SSRIs).
Paradoxical Anxiety: Some patients with panic disorder may experience increased anxiety symptoms at the beginning of treatment with antidepressants. This paradoxical reaction usually subsides within the first 2 weeks of starting treatment. A low starting dose is advised to reduce the likelihood of an anxiogenic effect.
Seizures: Lexapro should be discontinued in any patient who develops seizures. SSRIs should be avoided in patients with unstable epilepsy and patients with controlled epilepsy should be carefully monitored. SSRIs should be discontinued if there is an increase in seizure frequency.
Mania: SSRIs should be used with caution in patients with a history of mania/hypomania. SSRIs should be discontinued in any patient entering a manic phase.
Diabetes: In patients with diabetes, treatment with an SSRI may alter glycemic control. Insulin and/or oral hypoglycemic dosage may need to be adjusted.
Suicide: The possibility of suicide attempt is inherent in depression and may persist until significant improvement occurs, either spontaneously or following treatment.
Patients being treated with antidepressants should be monitored carefully especially at the beginning of treatment for clinical worsening and/or the emergence of suicidality (suicidal ideation and behavior).
This precaution should also be observed when treating other psychiatric disorders because of the possibility of co-morbidity with major depressive disorder.
Hyponatremia: Hyponatremia, probably due to inappropriate antidiuretic hormone secretion (SIADH), has been reported rarely with the use of SSRIs and generally resolves on discontinuation of therapy. Caution should be exercised in patients at risk eg, elderly, cirrhotic patients or patients concomitantly treated with medications known to cause hyponatremia.
Hemorrhage: There have been reports of cutaneous bleeding abnormalities eg, ecchymoses and purpura, with SSRIs. Caution is advised in patients taking SSRIs, particularly with concomitant use of oral anticoagulants, with medicinal products known to affect platelet function [eg, atypical antipsychotics and phenothiazines, most tricyclic antidepressants, acetylsalicylic acid and nonsteroidal anti-inflammatory medicinal products (NSAIDs), ticlopidine and dipyridamole] and in patients with known bleeding tendencies.
Electroconvulsive Therapy (ECT): There is limited clinical experience of concurrent administration of SSRIs and ECT, therefore caution is advisable.
Reversible, Selective MAO-A Inhibitors: The combination of escitalopram with MAO-A inhibitors is generally not recommended due to the risk of onset of a serotonin syndrome. Concomitant treatment with nonselective, irreversible MAO inhibitors.
Serotonin Syndrome: Caution is advisable if escitalopram is used concomitantly with medicinal products with serotonergic effects eg, sumatriptan or other triptans, tramadol and tryptophan.
In rare cases, serotonin syndrome has been reported in patients using SSRIs concomitantly with serotonergic medicinal products. A combination of symptoms eg, agitation, tremor, myoclonus and hyperthermia may indicate the development of this condition. If this occurs, treatment with the SSRI and the serotonergic medicinal product should be discontinued immediately and symptomatic treatment initiated.
St. John's Wort: Concomitant use of SSRIs and herbal remedies containing St. John's wort (Hypericum perforatum) may result in an increased incidence of adverse reactions.
Withdrawal Reactions: When stopping therapy with Lexapro, the dose should be gradually reduced over a period of 1 or 2 weeks in order to avoid possible withdrawal reactions.
Effects on the Ability to Drive or Operate Machinery: Although escitalopram has been shown not to affect intellectual function or psychomotor performance, any psychoactive medicinal product may impair judgment or skills. Patients should be cautioned about the potential risk of an influence on their ability to drive a car and operate machinery.
Use in Pregnancy: For escitalopram, only limited clinical data are available regarding exposures in pregnancy. Escitalopram should not be used during pregnancy unless clearly necessary and only after careful consideration of the risk/benefit ratio.
In reproductive toxicity studies performed in rats with escitalopram, embryo-fetotoxic effects were observed, but no increased incidence of malformations. Using SSRIs in the 3rd trimester may result in effects, including neurobehavioral disturbances in the newborn infant.
The following effects were reported in neonates with SSRIs administered to pregnant women until date of birth: Irritability, tremor, hypertonia, increased muscle tone, constant crying, difficulty in suckling or in sleeping.
They may either indicate serotonergic effects or withdrawal syndrome. If used during pregnancy, SSRIs should never be stopped abruptly.
Use in Lactation: It is expected that escitalopram will be excreted into human milk, and breastfeeding is not recommended during treatment.
Use in Children: Use in children and adolescents (<18 years) is not recommended since efficacy has not been investigated in this population.
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