Eslo Special Precautions



Hetero Labs


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Special Precautions
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 two weeks of treatment. A low starting dose is advised to reduce the likelihood of an anxiogenic effect.
Seizures: The medicinal product 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 patients 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/Suicidal thought: Depression is associated with an increased risk of suicidal thoughts, self-harm and suicide (suicide-related events). This risk persists until significant remission occurs. As improvement may not occur during the first few weeks or more of treatment, patients should be closely monitored until such improvement occurs. It is general clinical experience that the risk of suicide may increase in the early stages of recovery. Other psychiatric conditions for which Escitalopram in prescribed can also be associated with an increased risk of suicide-related events. In addition, these conditions may be co-morbid with major depressive disorder. The same precautions observed when treating patients with major depressive disorder should therefore be observed when treating patients with other psychiatric disorders.
Patients with a history of suicide related events, or those exhibiting a significant degree of suicidal ideation prior to commencement of treatment are at greater risk of suicidal thoughts or suicidal attempts, and should receive careful monitoring during treatment. In addition, there is a possibility of an increased risk of suicidal behaviour in young adults. Patients (and caregivers of patients) should be alerted about the need to monitor for the emergence of such events and to seek medical advice immediately if these symptoms present.
Akathisia/psychomotor restlessness: The use of SSRIs/SNRIs has been associated with the development of akathisia, characterized by a subjective unpleasant or distressing restlessness and to move often accompanied by an inability to sit or stand still. This is most likely to occur within the first few weeks of treatment. In patients who develop these symptoms, increasing the dose may be detrimental.
Hyponatraemia: 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, such as elderly, cirrhotic patients or patients concomitantly treated with medications known to cause hyponatraemia.
Haemorrhage: There have been reports of cutaneous bleeding abnormalities, such as ecchymoses and purpura with SSRIs. Caution is advised in patients taking SSRIs particularly with concomitant use of oral anticoagulants, medicinal products known to affect platelet function (e.g. atypical antipsychotic and phenothiazines, most tricyclic antidepressants, acetylsalicylic acid and non-steroidal anti-inflammatory medicinal products (NSAIDs), ticlopidine and dipyridamole) and in patients with known bleeding tendencies.
ECT (Electroconvulsive therapy): 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.
Serotonin Syndrome: Caution is advisable if Escitalopram is used concomitantly with medicinal products with serotonergic effects such as 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 such as 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 indicated.
Potential for interaction with Monoamine Oxidase Inhibitors: In patients receiving serotonin reuptake inhibitor drugs in combination with a Monoamine Oxidase Inhibitors (MAOI) there have been reports of serious, sometimes fatal reactions including hyperthermia, rigidity, myoclonus, autonomic instability with possible rapid fluctuations of vital signs and mental status changes that include extreme agitation progressing to delirium and coma. These reactions have also been reported in patients who have recently discontinued SSRI treatment and have been started on a MAOI. Some cases presented with features resembling neuroleptic malignant syndrome. Furthermore limited animal data on the effects of combined use of SSRIs and MAOIs suggest that these drugs may act synergistically to elevate blood pressure and evoke behavioral excitation therefore it is recommended that ESLO should not be used in combination with a MAOI or within 14 days of discontinuing treatment with a MAOI. Similarly at least 7 days should be allowed after stopping ESLO before starting a MAOI.
St. John's Wort: Concomitant use of SSRI and herbal remedies containing St. John's Wort (Hypericum perforatum) may result in an increased incidence of adverse reactions.
Discontinuation symptoms seen when stopping treatment: Discontinuation symptoms seen when stopping treatment are common, particularly if discontinuation is abrupt.
The risk of discontinuation symptoms may be dependent on several factors including the duration and dose of therapy and the rate of dose reduction. Dizziness, sensory disturbances (including paraesthesia, and electric shock sensations), sleep disturbances (including insomnia and intense dreams), agitation or anxiety, nausea and/or vomiting, tremor, confusion, sweating, headache, diarrhea, palpitations, emotional instability, irritability and visual disturbances are the most commonly reported reactions. Generally those reactions are mild to moderate; however, in some patients they may be severe in intensity.
They usually occur within the first few days of discontinuing treatment, but there have been very rare reports of such symptoms in patients who have inadvertently missed a dose.
Generally these symptoms are self-limiting and usually resolve within 2 weeks, though in some individuals they may be prolonged (2-3 months or more). It is therefore advised that Escitalopram should be gradually tapered when discontinuing treatment over a period of several weeks or months, according to the patient's needs.
Special warning - Suicidality in Children and Adolescents: Escitalopram should not be used in the treatment of children and adolescents under the age of 18 years. Antidepressants increase the risk of suicidal thinking and behavior (suicidality) in children and adolescents with major depressive disorder (MDD) and other psychiatric disorder. Anyone considering the use of an antidepressant in a child or adolescent for any clinical use must balance the risk of an increased suicidality with the clinical need. If, based on clinical need, a decision to treat is nevertheless taken, patients who are started on therapy should be observed closely for clinical worsening, suicidality, or unusual change in behavior. Families and caregivers should be advised to closely observe the patient and to communicate with the prescriber.
Effects on ability to drive and use machines: Although Escitalopram has been shown not to affect intellectual function or psychomotor performance, any psychoactive medicinal product may impair judgement or skills. Patient should be cautioned about the potential risk of an influence on their ability to drive a car and operate machinery.
Antidepressants should not be used in the treatment of children and adolescents under age at 18 years. Suicide related behaviors (suicide attempt and suicidal thoughts) and hostility (predominantly aggression oppositional behavior and anger) were more frequently observed in children and adolescent treated with antidepressants compared to those treated with placebo. If based on clinical need, a decision to treat nevertheless taken, the patient should be carefully monitored for the appearance of suicidal symptoms.
The following special warnings and precautions apply to the therapeutic class of SSRIs (Selective Serotonin Reuptake inhibitors).
Carcinogenesis: Racemic citalopram was administered in the diet to NMRI/BOM strain mice and COBS WI strain rats for 18 and 24 months, respectively. There was no evidence for carcinogenicity of racemic citalopram in mice receiving up to 240 mg/kg/day. There was an increased incidence of small intestine carcinoma in rats receiving 8 or 24 mg/kg/day racemic citalopram. A no-effect dose for this finding was not established. The relevance of these findings to humans is unknown.
Mutagenesis: Racemic citalopram was mutagenic in the in vitro bacterial reverse mutation assay (Ames test) in 2 of 5 bacterial strains (Salmonella TA98 and TA1537) in the absence of metabolic activation. It was clastogenic in elhe in vitro Chinese hamster lung cell assay for chromosomal aberrations in the presence and absence of metabolic activation. Racemic Citalopram was not mutagenic in the in vitro mammalian forward gene mutation assay (HPRT) in mouse lymphoma cells or in a coupled in vitro/in vivo unscheduled DNA synthesis (UDS) assay in rat liver. It was not clastogenic in the in vitro chromosomal aberration assay in human lymphocytes or in two in vivo mouse micronucleus assays.
Impairment of Fertility: When racemic citalopram was administered orally to 16 male and 24 female rats prior to and throughout mating and gestation at doses of 32, 48, and 72 mg/kg/day, mating was decreased at all doses and fertility was decreased at doses ≥32 mg/kg/day. Gestation duration was increased at 48 mg/kg/day.
Use in Children: Safety and effectiveness in pediatric patients have not been established.
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