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Home , Dosulepin, Northiaden, Quinidine, Tetracyclic, Tricyclic antidepressant

Leaflet 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. received perspiration. treatment Withdrawal micturition, are accommodation, -like General Increased Investigations Asthenia General Interference Reproductive Skin Skin Hepatobiliary normal Gastrointestinal Dyspepsia, overdosage dizziness P Cardiac T Nervous exacerbated , P Psychiatric Hypersensitivity Endocrine Immune Bone Metabolic side Inappropriate Blood . reported The ADVERSE minor Initially, EFFECTS feeding /metabolites Lactation r s o e y s m c t effects rashes, u h and following o marrow influence r o and r a doses. s t should Dosulepin l i Information and disorders ,

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6 monoamine Phar Pharmacodynamic properties PHARMACOLOGICAL PROPERTIES develop. with Use with Hepatic Impairment develop. with Use with Renal Impairment The useofDosulepininchildrenhasnotbeenstudied. Children with any require The Elderly night, as e.g. inhospitaluse,dosage Suggested dose prescribers Initially, Adults DOSAGE ANDADMINISTRATION received Initiation intolerant its illness, Dosulepin INDICATIONS ingredients. country. Inactive Inactive Ingredients molecular water, powder Dosulepin t Dosulepin PRODUCT DESCRIPTION h F (Dosulepin Hydrochloride) i e toxicity il a

PROTHIADEN m p tricyclic recommended caution maco impaired single at impaired i

it C n chloroform, is especially - night, a

that o administer 1 Consult ingredients caution and caution and better a lower of 1 properties. weight Dosulepin in ther of is t hydrochloride hydrochloride regimen: - e (see dose under y For theinformationofMedicalProfession antidepressant, overdose, indicated is d treatment or l increasing i apeu hepatic d almost renal to starting e PRECAUTIONS unresponsive the is at n give where close and e 331.9. dose 75 night. ) approved 25

inhibitors The reduce the reduce the in function should in a without alcohol function, Dosulepin mg p to grou supervision smaller dose for the r to is an Dosulepin o is 50 is chemical If 50 p 150 daily s upto225mg/day anti- treatment p: y 150 patients a the a mg l to and but d be odor. manufacturing white as mg/day. to tricyclic i dose Anti 75 m initial three as in mg dosage of dosage of and is should e alternative slow restricted increased mg divided t almost (see name depr increased h The may as for to OVERDOSAGE). who y of times dose daily. l a In dose a antidepressant effect faintly the symptoms essa WARNINGS). only compound m single certain vary is insoluble i have doses Dosulepin in Dosulepin in first n should daily Elderly 3-(6H-dibenzo(b,e)- e nts, escalation. to formula be treatment blood is

blood yellow have beenused. few from required. dose h used specialist

or circumstances, not y or non- d of be nights. 75 patients in is r levels as levels o depressive for country is in previously ether. crystalline increased to soluble c sele that h a given patients patients options. patients specific As 150 l Due o single r ctiv care may may may i with The has d mg e at to to in e .

Mechanism of Action the administered dose was recovered from the and 15% and potentially fatal doses. Onset of toxicity occurs within 4-6 Dosulepin is a that acts by increasing from the . hours. transmitter levels at central , so producing a clinical ! A limited number of tablets should be prescribed to antidepressant effect. In common with other , 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 . 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 . 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 Dosulepin is contraindicated for the treatment of mania. occurs. Avoid concomitant which may numbers and noradrenaline induced cyclic-AMP formation. The Dosulepin is contraindicated for patients with severe liver . increase the risk of toxicity associated with Dosulepin secondary metabolite of Dosulepin is a potent and selective Dosulepin is contraindicated for patients with known (see DRUG INTERACTIONS). noradrenaline 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 sulphoxide, are essentially Special warnings and precautions for use ! In cases of overdose, patients should seek inactive. I M M E D I A T E M E D I C A L A T T E N T I O N ( s e e Suicide/suicidal thoughts or clinical worsening OVERDOSAGE). Pharmacokinetic properties Dosulepin is readily absorbed from the and Depression is associated with an increased risk of suicidal Tricyclic antidepressants potentiate the central nervous extensively metabolized in the liver. Metabolites include thoughts, self harm and suicide (suicide-related events). This risk activity of alcohol (see DRUG INTERACTIONS). northiaden, Dosulepin-S-oxide, and northiaden-S-oxide. The persists until significant remission occurs. As improvement may dose is excreted in the urine, mainly in the form of metabolites; not occur during the first few weeks or more of treatment, patients DRUG INTERACTIONS appreciable amounts are also excreted in the feces. A half-life of should be closely monitored until such improvement occurs. It is Dosulepin should not be given concurrently with a monoamine about 50 hours has been reported for Dosulepin and its general clinical experience that the risk of suicide may increase in oxidase (MAO) inhibitor or within 14 days of ceasing such metabolites. the early stages of recovery. treatment.

Absorption Patients with a history of suicide-related events, or those The concomitant administration of Dosulepin and selective Following oral administration of single doses of 50 to 150 mg exhibiting a significant degree of prior to reuptake inhibitors (SSRI) should be avoided since Dosulepin to healthy subjects, peak plasma concentrations of commencement of treatment are known to be at greater risk of increases in plasma tricyclic antidepressant levels have been Dosulepin were achieved with 3 to 4 hours. These concentrations suicidal thoughts or suicide attempts, and should receive careful reported following the co-administration of some SSRI. were proportional to the administered dose and there were wide monitoring during treatment. A meta-analysis of placebo- Dosulepin may alter the pharmacological effect of some inter-subject variation in the concentrations obtained. In elderly controlled clinical trials of antidepressant drugs in adult patients concurrently administered drugs including CNS such healthy subjects who received a single oral dose of Dosulepin 25 with psychiatric disorders showed an increased risk of suicidal as alcohol and ; the effect of these will be mg peak plasma concentrations, time to peak concentration, and behaviour with antidepressants compared to placebo in patients potentiated, as will the effects of and noradrenaline. AUC values were all increased in comparison with young healthy less than 25 years old. Anesthetics given during tri/ antidepressant therapy subjects. may increase the risk of arrhythmias and . Close supervision of patients and in particular those at high risk Dosulepin has -like actions on the heart. For this reason, Distribution should accompany drug therapy especially in early treatment and its concomitant use with other drugs that may affect cardiac There is a wide variation in the mean apparent volume of following dose changes. Patients (and caregivers of patients) conduction (e.g. , , , ) distribution of the drug when it has been administered as a single should be alerted about the need to monitor for any clinical should be avoided. oral dose to healthy subjects, although rapid distribution after worsening, suicidal behaviour or thoughts and unusual changes in The hypotensive activity of certain antihypertensive agents (e.g. single 75 mg doses has been reported (distribution half-life 2.6 to behaviour and to seek medical advice immediately if these , debrisoquine, ) may be reduced by 2.9 hours). The volume of distribution is 45L/kg. The apparent symptoms present. Dosulepin. It is advisable to review all antihypertensive therapy volume of distribution was found to be more variable that the during treatment with tricyclic antidepressants. elimination half-life of Dosulepin and could account for the wide Avoid use in patients with a history of , thyroid disease, range of steady state concentrations which have been found in mania or and in those with narrow-angle There is an increased risk of postural hypotension when tricyclic patients taking Dosulepin. Dosulepin is 84% protein bound. glaucoma or symptoms suggestive of prostatic hypertrophy. antidepressants are given with . Patients with hepatic impairment and those undergoing Biotransformation electroconvulsive therapy should also avoid dosulepin use. The Tricyclic antidepressants may also antagonize the Dosulepin undergoes extensive metabolism by hepatic elderly are particularly liable to experience adverse effects with effect of antiepileptics (convulsive threshold decreased). microsomal enzyme after absorption for the gastrointestinal tract. tricyclic antidepressants (TCAs), especially agitation, , The main metabolic pathways in humans are S-oxidation and N- delirium, and postural hypotension. may decrease and may increase , resulting in the formation of the metabolites the serum concentration of Dosulepin and thus affect its Dosulepin-S-oxide, northiaden (desmethylDosulepin), and Dosulepin may increase the risk of cardiovascular toxicity (cardiac antidepressant action.There is no evidence that Dosulepin northiaden-S-oxide, which may become conjugated with arrhythmias, conduction disorders, cardiac failure and circulatory interferes with standard laboratory tests. glucuronic acid. It has been estimated that the oral collapse), especially in the elderly. of Dosulepin is about 30% after first pass hepatic metabolism, Caution should be exercised in using Dosulepin in the elderly and PREGNANCY AND LACTATION assuming there is complete absorption. in patients with suspected cardiovascular disease (see Pregnancy CONTRAINDICATIONS). Safe use of Dosulepin during pregnancy and lactation has not Elimination Anesthetics given during tri/tetracyclic antidepressant therapy been adequately studied. Withdrawal symptoms, including Following administration of single oral doses of Dosulepin 50 to may increase the risk of arrhythmias and hypotension. If surgery is insomnia, irritability, and excessive perspiration, have been 150 mg to healthy subjects, the terminal elimination half-lives of necessary, the anesthetist should be informed that a patient is reported in neonates whose mother received tricyclic the parent drug and its metabolites were as follows. being so treated (see DRUG INTERACTIONS). antidepressant treatment during the third trimester of pregnancy Dosulepin 18.5 - 21.5 hours On stopping treatment, it is recommended that antidepressants (see UNDESIRABLE EFFECTS). Use in pregnant women, Dosulepin-S-oxide 22.7 - 25.5 hours should be withdrawn gradually. nursing mothers and women whom may become pregnant Northiaden 37.6 - 45.7 hours requires that possible benefits be weighed against possible Northiaden-S-oxide 26.7 - 33.4 hours PRECAUTIONS hazard to mother and child. Dosulepin is associated with high mortality in overdose. There is a The major route of elimination is the kidney. After 96 hours, 56% of low margin of safety between the (maximum) therapeutic dose