(es sye tal' oh pram)
P / L : Caution - pregnancy & lactation (breast feeding)
|| See TERMINOLOGY & ABBREVIATIONS ||
SUICIDALITY AND ANTIDEPRESSANT DRUGS
Antidepressants increased the risk compared to placebo of suicidal thinking and behavior (suicidality) in children, adolescents, and young adults in short-term studies of major depressive disorder (MDD) and other psychiatric disorders. Anyone considering the use of escitalopram or any other antidepressant in a child, adolescent, or young adult must balance this risk with the clinical need. Short-term studies did not show an increase in the risk of suicidality with antidepressants compared to placebo in adults beyond age 24; there was a reduction in risk with antidepressants compared to placebo in adults aged 65 and older. Depression and certain other psychiatric disorders are themselves associated with increases in the risk of suicide. Patients of all ages who are started on antidepressant therapy should be monitored appropriately and observed closely for clinical worsening, suicidality, or unusual changes in behavior. Families and caregivers should be advised of the need for close observation and communication with the prescriber. Escitalopram Tablet is not approved for use in pediatric patients less than 12 years of age.
|Indication(s) & Dosage||
Hepatic impairment: Dosage adjustments may be required.
|Administration||May be taken with or without food.
|Overdosage||Symptoms include convulsions, coma, dizziness, hypotension, insomnia, nausea, vomiting, sinus tachycardia, somnolence, ECG changes (including QT prolongation and rarely, torsade de pointes). Treatment includes establishing and maintaining an airway to ensure adequate ventilation and oxygenation. Gastric lavage and activated charcoal may be used. Monitor cardiac and vital signs, along with general symptomatic and supportive care. Forced diuresis, dialysis, haemoperfusion, and exchange transfusion may not be useful.|
|Contraindications||Concomitant use with or within 2 wk of MAOI withdrawal.|
|Special Precautions||History of mania or seizure disorders; work requiring mental alertness; renal and hepatic impairment; pregnancy, lactation; withdraw gradually. Children and adolescents <18 yr|
|Adverse Drug Reaction(s)||Nausea, diarrhoea, increased sweating, insomnia, impotence, ejaculation disorder, fatigue, somnolence; postural hypotension, sinusitis, taste disturbances. Increased appetite and wt gain.|
|Drug Interactions||Increased risk of bleeding when used with aspirin, NSAIDs or drugs that affect coagulation. Serum levels may be reduced by CYP2C19 inducers (e.g. carbamazepine, rifampin, phenytoin) or CYP3A4 inducers (e.g. nafcillin, nevirapine). Serum levels may also be increased by CYP2C19 inhibitors (e.g. fluconazole, fluvoxamine, omeprazole) or CYP3A4 inhibitors (e.g. azole antifungals, clarithromycin). May increase serum levels of desipramine or metoprolol. Increased risk of serotonin syndrome when used with linezolid or sibutramine. Escitalopram may enhance the sedative effects of alcohol.
Potentially Fatal: Concomitant administration with MAOIs may lead to serious or fatal reactions; should not be started until at least 2 wk after stopping escitalopram or vice versa. Moclobemide may increase the risk of serotonin syndrome. Please consult detailed drug interactions before prescribing.
|Food Interaction||Increased CNS depression with valerian, St John's wort, kava kava and gotu kola.|
|Pregnancy Category (FDA)
||Category C: Either studies in animals have revealed adverse effects on the foetus (teratogenic or embryocidal or other) and there are no controlled studies in women or studies in women and animals are not available. Drugs should be given only if the potential benefit justifies the potential risk to the foetus.|
|Storage||Oral: Store at 25°C.|
||Escitalopram selectively inhibits CNS neuronal re-uptake of serotonin (5-HT) and potentiates serotonergic activity. It has minimal effects on norepinephrine and dopamine neuronal re-uptake.
Onset: 1-2 wk.
Absorption: Readily absorbed from the GI tract (oral).
Distribution: Protein-binding: 56%.
Metabolism: Hepatic; converted to metabolites.
Excretion: Urine (as unchanged drug); 27-32 hr (elimination half-life).
|ATC Classification||N06AB10 - escitalopram; Belongs to the class of selective serotonin reuptake inhibitors. Used in the management of depression.|
|Brand Name||Manufacturer/Marketer||Composition||Dosage Form||Pack Size & Price|
|CITALEX||Opsonin Pharma Limited||Escitalopram oxalate INN 10mg||Film Coated Tablet||20's: 160.00 MRP|
|CITALON||Popular Pharmaceuticals Ltd.||Escitalopram oxalate INN 10mg||Film Coated Tablet||30's: 240.92 MRP|
|Esipram 10||Incepta Pharmaceuticals Limited||Escitalopram INN 10 mg (as Escitalopram Oxalate)||Tablet||10x3's:MRP 300 Tk|
|Esipram 5||Incepta Pharmaceuticals Limited||Escitalopram INN 5 mg (as Escitalopram Oxalate)||Tablet||10x3's:MRP 165 Tk|
|ESITA 10mg||Healthcare Pharmacuticals Ltd.||Escitalopram INN 10 mg (as Escitalopram Oxalate)||Tablet||20's MRP 240 Tk|
|ESITA 5mg||Healthcare Pharmacuticals Ltd.||Escitalopram INN 5 mg (as Escitalopram Oxalate)||Tablet||20's MRP 140 Tk|
|LOSITA||Eskayef Bangladesh Ltd||Escitalopram INN 5mg & 10mg (as Escitalopram Oxalate)||Tablet (film-coated)||5mg x40's & 10mg x20's MRP: 200.00 & 160.00|
|MELIVA||Jayson Pharmaceuticals Ltd.||Escitalopram oxalate INN 10mg||Film Coated Tablet||30's: 240.90 IP|
|NEXCITAL||Unimed & Unihealth Manufacturers Ltd.||Escitalopram oxalate INN 5mg & 10mg||Film Coated Tablet||30's each: 165.00 & 300.00 MRP|
|NEXITO||Sun Pharmaceutical (Bangladesh) Ltd.||Escitalopram oxalate INN 5mg & 10mg||Film Coated Tablet||5mg x50's, 10mg x30's: 252.50 & 271.50 MRP|
|OXAPRO 10||Square Pharmaceuticals Ltd.||Escitalopram 10mg||Tablet||5x6's: 300.90 MRP|
|OXAPRO 5||Square Pharmaceuticals Ltd.||Escitalopram 5mg||Tablet||5x6's: 166.20 MRP|
|S-CITAPRAM||General Pharmaceuticals Ltd||Escitalopram oxalate INN 5mg & 10mg||Film Coated Tablet||5mg x30's, 10mg x20's: 165.60 & 200.80 MRP|
|SEROPAM 10||Beximco Pharmaceuticals Ltd||Escitalopram Oxalate INN eq. to 10mg Escitalopram||Tablet||30's: 240.00 MRP|
|SEROPAM 5||Beximco Pharmaceuticals Ltd||Escitalopram Oxalate INN eq. to 5mg Escitalopram||Tablet||30's: 165.00 MRP|
A small number of children, teenagers, and young adults (up to 24 years of age) who took antidepressants ('mood elevators') such as escitalopram during clinical studies became suicidal (thinking about harming or killing oneself or planning or trying to do so). Children, teenagers, and young adults who take antidepressants to treat depression or other mental illnesses may be more likely to become suicidal than children, teenagers, and young adults who do not take antidepressants to treat these conditions. However, experts are not sure about how great this risk is and how much it should be considered in deciding whether a child or teenager should take an antidepressant. Children younger than 12 years of age should not normally take escitalopram, but in some cases, a doctor may decide that escitalopram is the best medication to treat a child's condition.
You should know that your mental health may change in unexpected ways when you take escitalopram or other antidepressants even if you are an adult over 24 years of age. You may become suicidal, especially at the beginning of your treatment and any time that your dose is increased or decreased. You, your family, or your caregiver should call your doctor right away if you experience any of the following symptoms: new or worsening depression; thinking about harming or killing yourself, or planning or trying to do so; extreme worry; agitation; panic attacks; difficulty falling asleep or staying asleep; aggressive behavior; irritability; acting without thinking; severe restlessness; and frenzied abnormal excitement. Be sure that your family or caregiver knows which symptoms may be serious so they can call the doctor if you are unable to seek treatment on your own.
Your healthcare provider will want to see you often while you are taking escitalopram, especially at the beginning of your treatment. Be sure to keep all appointments for office visits with your doctor.
The doctor or pharmacist will give you the manufacturer's patient information sheet (Medication Guide) when you begin treatment with escitalopram. Read the information carefully and ask your doctor or pharmacist if you have any questions. You also can obtain the Medication Guide from the FDA website:http://www.fda.gov/Drugs/DrugSafety/ucm085729.htm.
No matter your age, before you take an antidepressant, you, your parent, or your caregiver should talk to your doctor about the risks and benefits of treating your condition with an antidepressant or with other treatments. You should also talk about the risks and benefits of not treating your condition. You should know that having depression or another mental illness greatly increases the risk that you will become suicidal. This risk is higher if you or anyone in your family has or has ever had bipolar disorder (mood that changes from depressed to abnormally excited) or mania (frenzied, abnormally excited mood) or has thought about or attempted suicide. Talk to your doctor about your condition, symptoms, and personal and family medical history. You and your doctor will decide what type of treatment is right for you.
Why is this medication prescribed?
Escitalopram is used to treat depression and generalized anxiety disorder (GAD; excessive worry and tension that disrupts daily life and lasts for 6 months or longer). Escitalopram is in a class of antidepressants called selective serotonin reuptake inhibitors (SSRIs). It works by increasing the amount of serotonin, a natural substance in the brain that helps maintain mental balance.
How should this medicine be used?
Escitalopram comes as a tablet and a solution (liquid) to take by mouth. It is usually taken once a day with or without food. To help you remember to take escitalopram, take it at around the same time every day, in the morning or in the evening. Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Take escitalopram exactly as directed. Do not take more or less of it or take it more often than prescribed by your doctor.
Your doctor may start you on a low dose of escitalopram and increase your dose after 1 week.
It may take 1 to 4 weeks or longer before you feel the full benefit of escitalopram. Continue to take escitalopram even if you feel well. Do not stop taking escitalopram without talking to your doctor. If you suddenly stop taking escitalopram, you may experience withdrawal symptoms such as mood changes, irritability, agitation, dizziness, numbness or tingling in the hands or feet, anxiety, confusion, headache, tiredness, and difficulty falling asleep or staying asleep. Your doctor will probably decrease your dose gradually.
Other uses for this medicine
This medication may be prescribed for other uses; ask your doctor or pharmacist for more information.
What special precautions should I follow?
Before taking escitalopram,
- tell your doctor or pharmacist if you are allergic to escitalopram, citalopram, or any other medications.
- tell your doctor if you are taking pimozide or a monoamine oxidase inhibitor such as isocarboxazid, phenelzine, selegiline, and tranylcypromine, or if you have stopped taking an MAO inhibitor within the past 14 days. Your doctor will probably tell you not to take escitalopram. If you stop taking escitalopram, you should wait at least 14 days before you start to take an MAO inhibitor.
- you should know that escitalopram is very similar to another SSRI, citalopram . You should not take these two medications together.
- tell your doctor or pharmacist what prescription and nonprescription medications and vitamins you are taking or plan to take. Be sure to mention any of the following: anticoagulants such as warfarin; antihistamines; aspirin and other nonsteroidal anti-inflammatory drugs such as ibuprofen and naproxen; carbamazepine; cimetidine; ketoconazole; lithium; linezolid; medications for anxiety, mental illness, or seizures; medications for migraine headaches such as almotriptan, eletriptan, frovatriptan, naratriptan, rizatriptan, sumatriptan, and zolmitriptan; metoprolol; other antidepressants such as desipramine; sedatives; sibutramine; sleeping pills; tramadol; methylene blue; and tranquilizers. Your doctor may need to change the doses of your medications or monitor you carefully for side effects.
- tell your doctor what nutritional supplements and herbal products you are taking, especially products containing St. John's wort or tryptophan.
- tell your doctor if you have recently had a heart attack and if you have or have ever had seizures or liver, kidney, thyroid, or heart disease.
- tell your doctor if you are pregnant, especially if you are in the last few months of your pregnancy, or if you plan to become pregnant or are breast-feeding. If you become pregnant while taking escitalopram, call your doctor. Escitalopram may cause problems in newborns following delivery if it is taken during the last months of pregnancy.
- if you are having surgery, including dental surgery, tell the doctor or dentist that you are taking escitalopram.
- you should know that escitalopram may make you drowsy. Do not drive a car or operate machinery until you know how this medication affects you.
- remember that alcohol can add to the drowsiness caused by this medication.
What special dietary instructions should I follow?
Unless your doctor tells you otherwise, continue your normal diet.
What should I do if I forget a dose?
Take the missed dose as soon as you remember it. However, if it is almost time for the next dose, skip the missed dose and continue your regular dosing schedule. Do not take a double dose to make up for a missed one.
What side effects can this medication cause?
Escitalopram may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:
changes in sex drive or ability
Some side effects can be serious. If you experience either of the following symptoms or those listed in the IMPORTANT WARNING section, call your doctor immediately:
seeing things or hearing voices that do not exist (hallucinating)
fever, sweating, confusion, fast or irregular heartbeat, and severe muscle stiffness
Escitalopram may cause other side effects. Call your doctor if you have any unusual problems while taking this medication.
What should I know about storage and disposal of this medication?
Keep this medication in the container it came in, tightly closed, and out of reach of children. Store it at room temperature and away from excess heat and moisture (not in the bathroom). Throw away any medication that is outdated or no longer needed. Talk to your pharmacist about the proper disposal of your medication.
In case of emergency/overdose
In case of overdose, consult your doctor. If the victim has collapsed or is not breathing, consult local medical emergency services.
Symptoms of overdose may include:
fast or pounding heartbeat
coma (loss of consciousness for a period of time)
What other information should I know?
Keep all appointments with your doctor and the laboratory. Your doctor will order certain lab tests to check your response to this medicine.
Do not let anyone else use your medication. If you still have symptoms and need further treatment, consult your doctor.
It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.
Ref: U.S. National Library of Medicine.
This information is provided for reference only and not a replacement for and should only be used in conjunction with full consultation with a registered medical practitioner. It may not contain all the available information you require and cannot substitute professional medical care, nor does it take into account all individual circumstances. Although great effort has been made to ensure content accuracy, mph-bd shall not be held responsible or liable for any claims or damages arising from the use or misuse of the information contained herein, its contents or omissions, or otherwise.