CIPRA-PRO 10 TAB; citalopram, antidepressants .
ACTIVE-INGREDIENT OF CIPRA-PRO 10 TAB
Each tablet contains: 10 mg escitalopram (as oxalate).
INDICATION OF CIPRA-PRO 10 TAB
Treatment of major depressive episodes. Treatment of panic disorder with or without agoraphobia. Treatment of social anxiety disorder (social phobia). Treatment of generalised anxiety disorder. Treatment of obsessive-compulsive disorder.
DOSAGE OF CIPRA-PRO 10 TAB
Follow all directions given to you by your pharmacist or doctor carefully . They may differ from the information contained in this leaflet
Ask your pharmacist or doctor for help if you do not understand the instructions on the box .
The recommended dose is : –
Safety and daily doses above 20 mg has not been demonstrated. CIPRA-PRO is administered as a single daily dose and may be taken with or without food. Major depressive episodes: Usual dosage is 10 mg once daily. Depending on individual patient response, the dose may be increased to a maximum of 20 mg daily. usually 2-4 weeks are necessary to obtain antidepressant response. After the sympyoms above, treatment for at least 6 months is required for consolidation of the response. Panic disorder with or without agoraphobia: An initial dose of 5 mg is recommended for the first week before increasing the dose to 10 mg daily. The dose may be further increased, up to a maximum of 20 mg daily, dependent on individual patient response. Maximum effectivness is reached after about 3 months. The treatment lasts several months. Social anxiety disorder: Usual dosage is 10 mg once daily. Usually 2-4 weeks are necessary to obtain symptom relief. The dose may subsequently, depending on individual patient response, be decreased to 5 mg or increased to a maximum of 20 mg daily. social anxiety disorder is a disease with a chronic course, and treatment for 12 weeks is recommended to consolidate response. Long-term treatment of responders has been studied for 6 months and can be considered on an individual basis to prevent relapse; treatment benefits should be re-evaluated at regular intervals. Social anxiety disorder is a well-defined diagnostic terminology of a specific disorder, which should not be confounded with excessive shyness. Pharmacotherapy is only indicated if the disorder interferes significantly with professional and social activities. The place of this treatment compared to cogitive behavioural therapy has not been assessed. Pharmacotherapy is part of an overall therapeutic strategy. Generalised anxiety disorder: Initial dosage is 10 mg once daily. Depending on individual patient response, the dose may be increased to a maximum of 20 mg daily. Long-term treatment of responders has been studied for at least 6 months receiving 20 mg daily. treatment benefits should be re-evaluated at regular intervals. Obsessive-compulsive disorder: Initial dosage is 10 mg once daily. Depending on individual patient response, the dose may be increased to a maximum of 20 mg daily. As OCD is a chronic disease, patients should be treated for a sufficient period to ensure that they are symptom free. treatment benefits should be re-evaluated at regular intervals. Elderly patients (> 65 years of age): Initial treatment with half the usually recommended dose and a lower maximum dose should be considered. The maximum daily dose is 10 mg for patients greater than 60 years of age. The efficiecy of CIPRA-PRO is social anxiety disorder has not been studied in elderly patients. Children and adolescents ( OVER-DOSAGE OF CIPRA-PRO 10 TAB
Toxicity : Clinical data on escitalopram overdose are limited and many cases involve concomitant overedoses of other drugs. In the majority of cases mild or no symptoms have been reported. Fatal cases of escitalopram overdose have rarely been reported with escitalopram alone; the majority of cases have involved overdose with concomitant medications. Doses between 400 and 800 mg of escitalopram alone have been taken without any severe symptoms. Symptoms: symptoms seen in reported overdose of escitalopram include symptoms mainly related to central nervous system ( ranging from dizziness, tremor, and agitation to rare cases of serotonin syndrome, convulsion, and coma ). the gastrointestinal system (nausea/vomiting), and the cardiovascular system (hypotension, tachycardia, QT prolongation, and arrhythmia) and electrolyte/fluid balance conditions ( hypokalaemia, hypoatraemia ). Treatment : There is no specific antidote. Establish and maintain an airway, ensure adequate oxygenation and respiratory function. Gastric lavage and the use of activated charcoal should be considered. Gastric lavage should be carried out as soon as possible after oral ingestion. Cardiac and vital signs monitoring are recommended along with general symptomatic supportive measures.
CONTRA-INDICATION OF CIPRA-PRO 10 TAB
Do not use of escitalopram with other medicinal products known to prolong the QT syndrome. Hypersensitivity to escitalopram or to any other of the ecipients. Concomitant treatment with non-selective, irreversible monoamine oxidase inhibitors (MAO-inhibitors) is contraindicated due to the risk of serotinin syndrome with agitation, tremor, hyperthremia etc. The combination of escitalopram with reversible MAO-A inhibitors ( e.g. moclobemide ) or the reversible non-selective MAO-inhibitor linezolid is contraindicated due to the risk of onset of a sertonin syndrome.
STORAGE OF CIPRA-PRO 10 TAB
Store at a temperature not exceeding 30 °C in a dry place.
PACK OF CIPRA-PRO 10 TAB
Carton box containing 1 Al/PVC strip of 10 film coated tablet and insert leaflet.
CIPRA-PRO 10 TAB MANUFACTURED BY
Copad Egypt for trade and pharmaceutical industries (Copad Pharma)