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Prothiaden 25Mg & 75Mg (Front) Size: 222 X 252Mm Colour: Black Date: 01-04-2014, 13-08-2014, 18-09-2014, 09-06-2015, 11-06-2015 Ammara Commercial Printers (Pvt.) Ltd d te a Lactation trimester of pregnancy have also been reported (see o Dosulepin/metabolites are excreted in human milk. Breast- PREGNANCY AND LACTATION). C m For the information of Medical Profession feeding should be discontinued during treatment with Dosulepin. il Class effects F EFFECTS ON ABILITY TO DRIVE AND USE MACHINES Epidemiological studies, mainly conducted in patients 50 years of PROTHIADEN Initially, Dosulepin may impair alertness; therefore Dosulepin has age and older, show an increased risk of bone fractures in patients minor influence on the ability to drive and use machines. receiving SSRIs and TCAs. The mechanism leading to this risk is (Dosulepin Hydrochloride) unknown. ADVERSE REACTIONS The following adverse effects, although not necessarily all OVERDOSAGE reported with Dosulepin, have occurred with other tricyclic Symptoms: PRODUCT DESCRIPTION antidepressants. Deaths may occur from overdosage with this class of drugs. Dosulepin hydrochloride is a tricyclic antidepressant that has Multiple drug ingestion (including alcohol) is common in deliberate anxiolytic properties. The chemical name is 3-(6H-dibenzo(b,e)- Blood and lymphatic system disorders tricyclic antidepressant overdose. Onset of toxicity occurs within thiepin-11-ylidene) propyldimethylamine hydrochloride. Bone marrow depression, agranulocytosis 4-6 hours after tricyclic antidepressant overdose. Dosulepin hydrochloride is a white to faintly yellow crystalline Symptoms of overdose include dry mouth, excitement, ataxia, powder that is almost without odor. The compound is soluble in Immune system disorder drowsiness,unconsciousness, muscle twitching, convulsions, water, chloroform, and alcohol but is almost insoluble in ether. The Hypersensitivity reactions widely dilated pupils, hyperreflexia, sinus tachycardia, cardiac molecular weight is 331.9. arrhythmias, hypotension, hypothermia, depression of respiration, visual hallucinations, delirium, urinary retention, Endocrine disorders Inactive Ingredients paralytic ileus, and respiratory or metabolic alkalosis. Inappropriate antidiuretic hormone (ADH) secretion, endocrine Inactive ingredients in Dosulepin may vary from country to Patients ingesting >5 mg/kg should seek immediate medical side effects country. Consult the approved manufacturing formula for specific attention. All children ingesting Dosulepin should be assessed by ingredients. Metabolic and nutrition disorder a physician. Hyponatremia INDICATIONS Treatment: Dosulepin is indicated in the treatment of symptoms of depressive A clear airway and adequate ventilation should be ensured. 5 Psychiatric disorders illness, especially where an anti-anxiety effect is required. Due to 1 Hypoxia and acid-base imbalances should be corrected by Psychotic manifestations, including mania and paranoid its toxicity in overdose, Dosulepin should only be used in patients 0 assisted ventilation and intravenous sodium bicarbonate as delusions, suicidal ideation and suicidal behavior may be intolerant of or unresponsive to alternative treatment options. 2 appropriate. Do not give flumazenil to reverse benzodiazepine - exacerbated during treatment with tricyclic antidepressants. Initiation of treatment for patients who have not previously 6 toxicity in mixed overdoses. received Dosulepin should be restricted to specialist care 0 - Nervous system disorders prescribers (see PRECAUTIONS and OVERDOSAGE). 1 Tremors, drowsiness, convulsions, movement disorders, The use of activated charcoal should be considered as a preferred 1 initial means of reducing absorption in patients presenting within 2 dizziness and headache , DOSAGE AND ADMINISTRATION hours of ingestion. Repeated gastric/intestinal aspiration or 5 repeated administration of activated charcoal may remove drug 1 Cardiac and Vascular disorders Adults 0 and metabolites excreted into the gut via the bile. Postural hypotension. Severe hypotension and cardiac Initially, administer 75 mg daily in divided doses or as a single 2 The benefit of gastric lavage is uncertain and the technique should - arrhythmias are likely to occur with high dosage or in deliberate dose at night, increasing to 150 mg/day. In certain circumstances, 6 be avoided in any patient with an impaired airway. When the overdosage or in patients with a pre-existing heart condition taking e.g. in hospital use, dosages up to 225 mg/day have been used. 0 patient is unconscious, or the cough reflex is depressed, the lungs - normal doses. Suggested regimen: 25 to 50 mg three times daily or 75 to 150 mg 9 should be protected by a cuffed endotracheal tube. Forced as a single dose at night. If 150 mg as a single dose is given at 0 diuresis is not recommended. Gastrointestinal disorders , Blood pressure, pulse and cardiac rhythm should be monitored for night, it is better to give a smaller dose for the first few nights. 4 Dyspepsia, Abdominal pain, diarrhea and nausea ) t at least 6 hours after ingestion. 1 Elderly n 0 . Arrhythmias are best treated by correcting hypoxia and acid-base Hepatobiliary disorders o The recommended dose is 50 to 75 mg daily. Elderly patients may 2 d r disturbances. t - Hepatitis (including altered liver function), cholestatic jaundice require a lower starting dose and slow dose escalation. As with F L 9 Specialist poisons advice should be sought before using any anti- ( any tricyclic antidepressant, the initial dose should be increased 0 ) arrhythmic agents as these may exacerbate the arrhythmia. In . - Skin and subcutaneous tissue disorders g t cases of cardiac arrest, persist with prolonged CPR (for at least 1 with caution under close supervision (see WARNINGS). 8 v Skin rashes, sweating 1 m hour). P , 5 Children ( Convulsions should be controlled with intravenous diazepam or 4 7 Reproductive system and breast disorders The use of Dosulepin in children has not been studied. s lorazepam. 1 r Interference with sexual function may occur & 0 Bed rest is advisable, even after recovery. e t Renal Impairment 2 g - n i General disorders and administration site conditions Use with caution and reduce the dosage of Dosulepin in patients 8 r STORAGE m Asthenia with impaired renal function as increased blood levels may 0 P Protect from heat, light & moisture. 5 - l develop. 2 3 a Investigations i 1 HOW SUPPLIED n c , Increased intraocular pressure, changes in blood sugar levels m Hepatic Impairment e r Prothiaden 25mg tablets: 100s Film-coated (No. N888) 4 e Use with caution and reduce the dosage of Dosulepin in patients d m Prothiaden 75mg tablets: 30s Film-coated (No.N889) 1 a General Information 2 with impaired hepatic function, as increased blood levels may m 0 i 5 Atropine-like side effects including dry mouth, disturbance of develop. 2 h k m 2 - t accommodation, tachycardia, constipation and hesitancy of c o 4 o x a micturition, are common early in treatment, but usually lessen as r l PHARMACOLOGICAL PROPERTIES 0 C - 2 treatment continues. P B 1 a Manufactured by: 2 : t r Pharmacodynamic properties 0 r 2 e a Abbott Laboratories (Pakistan) Ltd. Withdrawal symptoms may occur on abrupt discontinuation of : l u Pharmacotherapeutic group: Antidepressants, non-selective : f Landhi, Karachi. e 01-158R6 o m tricyclic therapy and include insomnia, irritability, and excessive e monoamine reuptake inhibitors l t a z perspiration. Similar symptoms in neonates whose mother o a i m e received tricyclic antidepressant treatment during the third L S C D A SOLID 1000311889 v3.0 21-Feb-2014 Mechanism of Action the administered dose was recovered from the urine and 15% and potentially fatal doses. Onset of toxicity occurs within 4-6 Dosulepin is a tricyclic antidepressant that acts by increasing from the feces. hours. transmitter levels at central synapses, so producing a clinical ! A limited number of tablets should be prescribed to antidepressant effect. In common with other tricyclics, Dosulepin Method of administration reduce the risk from overdose for all patients and inhibits the reuptake of noradrenaline and 5-hydroxytryptamine, The main dose should be taken at night. especially for patients at risk of suicide. with a significantly greater action on the reuptake of ! A maximum prescription equivalent to two weeks supply noradrenaline. In addition Dosulepin inhibits the neuronal uptake CONTRAINDICATIONS of 75 mg/day should be considered in patients with of dopamine. As a consequence of its effects on monoamine Dosulepin is contraindicated in patients with recent myocardial increased risk factors for suicide at initiation of treatment, levels, Dosulepin appears to produce adaptive changes in the infarction, any degree of heart block or other cardiac arrhythmias. during any dosage adjustment and until improvement brain by reducing or down-regulating both noradrenaline receptor Dosulepin is contraindicated for the treatment of mania. occurs. Avoid concomitant medications which may numbers and noradrenaline induced cyclic-AMP formation. The Dosulepin is contraindicated for patients with severe liver disease. increase the risk of toxicity associated with Dosulepin secondary amine metabolite of Dosulepin is a potent and selective Dosulepin is contraindicated for patients with known (see DRUG INTERACTIONS). noradrenaline reuptake inhibitor and this metabolite may hypersensitivity to Dosulepin hydrochloride or any the excipients. ! Patients should be advised to store the tablets contribute to the antidepressant effect. The other metabolites, securely, out of sight and reach of children. Dosulepin sulphoxide and northiaden sulphoxide, are essentially
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