The excipient polyoxyl hydrogenated castor oil may cause stomach upset and diarrhoea. Risk of suicide is inherent to severe depression and may persist until significant remission occurs. Patients posing a high suicide risk require close initial supervision. Anaesthesia Before general or local anaesthesia, the anaesthetist should be aware that the patient has been receiving Anafranil and of the possible interactions see 4.
Treatment Discontinuation Abrupt withdrawal should be avoided because of possible adverse reactions see 4. If the decision has been made to discontinue treatment, medication should be tapered as rapidly as is feasible, but with recognition that abrupt discontinuation can be associated with certain symptoms see section 4.
Anafranil may diminish or abolish the antihypertensive effects of guanethidine, betanidine, reserpine, clonidine and alpha-methyldopa. Patients requiring comedication for hypertension should therefore be given antihypertensives of a different type e.
Tricyclic antidepressants may potentiate the effects of these drugs e. Tricyclic antidepressants may potentiate the effects of alcohol and other central depressant substances e. Diuretics Comedication of Anafranil with diuretics may lead to hypokalemia, which in turn increases the risk of QTc prolongation and Torsades de Pointes.
Hypokalaemia should therefore be treated prior to administration of Anafranil see 4. Do not give Anafranil for at least 3 weeks after discontinuation of treatment with MAO inhibitors there is a risk of severe symptoms such as hypertensive crisis, hyperpyrexia and those consistent with Serotonin Syndrome e.
The same applies when giving a MAO inhibitor after previous treatment with Anafranil. In both instances the treatment should initially be given in small gradually increasing doses and its effects monitored. There is evidence to suggest that Anafranil may be given as little as 24 hours after a reversible MAO-A inhibitor such as moclobemide, but the 3 week wash-out period must be observed if the MAO-A inhibitor is used after Anafranil. Selective serotonin reuptake inhibitors: Co-medication with SSRI's may lead to additive effects on the serotonin system see serotonergic agents Serotenergic Agents: Seretonin Syndrome can possible occur when clomipramine is administered with serotonergic co-medications such as slective serotonin re-uptake inhibitors SSRIs , serotonin and nonadrenergic reuptake inhibitors SNaRI's , tricyclic antidepressants —or lithium.
For fluoxetine, a washout period of two to three weeks is advised before and after treatment with fluoxetine. Anafranil may potentiate the cardiovascular effects of adrenaline, ephedrine, isoprenaline, noradrenaline, phenylephrine, and phenylpropanolamine e.
Anafranil clomapramine is predominantly eliminated through metabolism. The primary route of metabolism is demethylation to form the active metabolite, N-desmethylclomipramine, followed by hydroxylation and further conjugation of both N-desmethylclomipramine and the parent drug. Hyperthermia has been reported in patients receiving Anafranil. Most cases were in combination with other drugs, including neuroleptic agents. Sexual dysfunction, including ejaculatory failure and impotence, is common in males.
Increases and decreases in weight can occur with use of Anafranil. Concurrent administration of Anafranil with electroconvulsive therapy may increase the risks. Prior to elective surgery with general anesthetics, therapy with Anafranil should be discontinued for as long as is clinically feasible, and the anesthetist should be advised.
Caution use in patients with the following concomitant Illnesses: Withdrawal symptoms have been reported in association with abrupt discontinuation of Anafranil. It is recommended that the dosage be tapered gradually and the patient monitored carefully during discontinuation. Anafranil may exaggerate the effects of alcohol, barbiturates, or other CNS depressants. Fobii si atacuri de panica; catalepsie acompaniind narcolepsia; stari dureroase cronice; enurezis nocturn peste varsta de 5 ani si excluzand cauzele organice.
Antidepresiv triciclic Forma de prezentare: Cutie cu 30 drajeuri continand 10 mg clomipramina Anafranil Cutie cu 30 drajeuri continand 25 mg clomipramina Anafranil Cutie cu 10 fiole continand 25 mg clomipramina in 2 ml apa. Probabil principala actiune pe care o are Anafranil-ul este inhibitia recaptarii noradrenalinei NA si in special - acesta fiind efectul dominant - a serotoninei 5-HT la nivelul sinapsei neuronale. Caracteristic Anafranil-ului este spectrul larg de actiune, incluzand proprietati alfa1-adrenolitice, anticolinergice, antihistaminice si antiserotoninice blocarea receptorilor 5-HT.
Substanta activa se absoarbe complet prin administrare orala sau intramusculara. Prin administrarea orala zilnica a unei cantitati constante de Anafranil, concentratiile plasmatice ale clomipraminei CP difera mult de la un pacient la altul. Variabilitatea clomipraminemiei la acelasi bolnav este neglijabila comparativ cu cea care apare la pacienti diferiti. Dozele necesare tratamentului pacientilor varstnici trebuie ajustate proportional clearance-ului scazut al acestora.
Legarea de proteinele plasmatice: Timpul de injumatatire a fazei beta a eliminarii: Hipersensibilitate cunoscuta la antidepresivele triciclice din grupul dibenzazepinelor. Tratament concomitent cu inhibitori de monoaminoxidaza IMAO.
Anafranil-ul nu trebuie administrat in stadiul acut al infarctului miocardic. Insuficienta circulatorie, bloc atrioventricular gradele I-III , aritmii. Antidepresivele triciclice trebuie administrate cu precautie la pacientii cu tulburari cardiovasculare, in special tulburari de conducere, precum si la cei varstnici.
Monitorizarea si ECG se indica in astfel de cazuri. Glaucom cu unghi ingust. Tulburari de mictiune datorita unui obstacol ex. Prag scazut de convulsie ex. Testele clinice ale Anafranil-ului au evidentiat o relatie clara intre doza administrata si frecventa crizelor. Boli severe hepatice si renale. Pacienti cu tumori ale medulosuprarenalei ex. Tratamentul cu antidepresive triciclice la bolnavii sub terapie anticonvulsivanta trebuie supus unei supravegheri atente.
Multi pacienti cu antecedente de atacuri de panica au remarcat accentuarea anxietatii la inceputul tratamentului cu Anafranil, situatie paradoxala care persista circa 2 saptamani. Au fost raportate si cazuri izolate de soc anafilactic. Inaintea inceperii tratamentului cu Anafranil, se recomanda investigarea tensiunii arteriale, intrucat se poate accentua hipotensiunea la cei cu circulatie labila sau hipotensiune.
Datorita actiunii anticolinergice a Anafranil-ului, pot aparea agravari ale statusului cardiac al pacientilor hipertiroidieni sau al celor care sunt sub tratament cu preparate tiroidiene. Plasma concentrations of clomipramine were significantly lower in smokers than in nonsmokers. The obsessions or compulsions must cause marked distress, be time-consuming, or significantly interfere with social or occupational functioning, in order to meet the DSM-III-R circa diagnosis of OCD. Obsessions are recurrent, persistent ideas, thoughts, images, or impulses that are ego-dystonic.
Compulsions are repetitive, purposeful, and intentional behaviors performed in response to an obsession or in a stereotyped fashion, and are recognized by the person as excessive or unreasonable. The effectiveness of clomipramine for the treatment of OCD was demonstrated in multicenter, placebo-controlled, parallel-group studies, including two week studies in adults and one 8-week study in children and adolescents 10 to 17 years of age.
Clomipramine-treated patients experienced a 3. Patients on placebo showed no important clinical response on either scale. The effectiveness of clomipramine for long-term use i. Clomipramine should not be given in combination, or within 14 days before or after treatment, with a monoamine oxidase MAO inhibitor. Hyperpyretic crisis, seizures, coma, and death have been reported in patients receiving such combinations.
Clomipramine is contraindicated during the acute recovery period after a myocardial infarction. There has been a long-standing concern that antidepressants may have a role in inducing worsening of depression and the emergence of suicidality in certain patients. Antidepressants increased the risk of suicidal thinking and behavior suicidality in short-term studies in children and adolescents with Major Depressive Disorder MDD and other psychiatric disorders.
Pooled analyses of short-term placebo-controlled trials of 9 antidepressant drugs SSRIs and others in children and adolescents with MDD, OCD, or other psychiatric disorders a total of 24 trials involving over patients have revealed a greater risk of adverse events representing suicidal behavior or thinking suicidality during the first few months of treatment in those receiving antidepressants.
There was considerable variation in risk among drugs, but a tendency toward an increase for almost all drugs studied. The risk of suicidality was most consistently observed in the MDD trials, but there were signals of risk arising from some trials in other psychiatric indications obsessive compulsive disorder and social anxiety disorder as well.
No suicides occurred in any of these trials. It is unknown whether the suicidality risk in pediatric patients extends to longer-term use, i. It is also unknown whether the suicidality risk extends to adults.
All pediatric patients being treated with antidepressants for any indication should be observed closely for clinical worsening, suicidality, and unusual changes in behavior, especially during the initial few months of a course of drug therapy, or at times of dose changes, either increases or decreases.
Such observation would generally include at least weekly face-to-face contact with patients or their family members or caregivers during the first 4 weeks of treatment, then every other week visits for the next 4 weeks, then at 12 weeks, and as clinically indicated beyond 12 weeks.
Additional contact by telephone may be appropriate between face-to-face visits. Adults with MDD or co-morbid depression in the setting of other psychiatric illness being treated with antidepressants should be observed similarly for clinical worsening and suicidality, especially during the initial few months of a course of drug therapy, or at times of dose changes, either increases or decreases.
The following symptoms, anxiety, agitation, panic attacks, insomnia, irritability, hostility, aggressiveness, impulsivity, akathisia psychomotor restlessness , hypomania, and mania, have been reported in adult and pediatric patients being treated with antidepressants for major depressive disorder as well as for other indications, both psychiatric and nonpsychiatric.
Consideration should be given to changing the therapeutic regimen, including possibly discontinuing the medication, in patients whose depression is persistently worse, or who are experiencing emergent suicidality or symptoms that might be precursors to worsening depression or suicidality, especially if these symptoms are severe, abrupt in onset, or were not part of the patient's presenting symptoms. Families and caregivers of pediatric patients being treated with antidepressants for major depressive disorder or other indications, both psychiatric and nonpsychiatric, should be alerted about the need to monitor patients for the emergence of agitation, irritability, unusual changes in behavior, and the other symptoms described above, as well as the emergence of suicidality, and to report such symptoms immediately to health care providers.
Such monitoring should include daily observation by families and caregivers. Prescriptions for clomipramine hydrochloride should be written for the smallest quantity of capsules consistent with good patient management, in order to reduce the risk of overdose.
Families and caregivers of adults being treated for depression should be similarly advised. Screening Patients for Bipolar Disorder A major depressive episode may be the initial presentation of bipolar disorder.
Whether any of the symptoms described above represent such a conversion is unknown. However, prior to initiating treatment with an antidepressant, patients with depressive symptoms should be adequately screened to determine if they are at risk for bipolar disorder; such screening should include a detailed psychiatric history, including a family history of suicide, bipolar disorder, and depression.
It should be noted that clomipramine hydrochloride is not approved for use in treating bipolar depression. Seizures During premarket evaluation, seizure was identified as the most significant risk of clomipramine hydrochloride use. The cumulative rates correct the crude rate of 0.
Although dose appears to be a predictor of seizure, there is a confounding of dose and duration of exposure, making it difficult to assess independently the effect of either factor alone. The ability to predict the occurrence of seizures in subjects exposed to doses of clomipramine hydrochloride greater than mg is limited, given that the plasma concentration of clomipramine may be dose-dependent and may vary among subjects given the same dose.
Plasma concentrations of the metabolite exceed the parent drug on multiple retard. Therefore, dose adjustments of Bijsluiter may be necessary when coadministered with terbinafine. Anafranil may potentiate the cardiovascular effects of adrenaline, ephedrine, isoprenaline, noradrenaline, phenylephrine, and phenylpropanolamine e. Withdrawal Symptoms A retard of bijsluiter symptoms have been reported in association with abrupt discontinuation of clomipramine, anafranil retard 75mg bijsluiter, including retard, nausea, vomiting, headache, malaise, sleep disturbance, hyperthermia, and irritability. If the decision has been made to discontinue treatment, medication should be bijsluiter as rapidly as is anafranil, but with 75mg that abrupt discontinuation can be associated with certain symptoms see section 4. Cazuri izolate de leucopenie, anafranil retard 75mg bijsluiter, agranulocitoza, trombocitopenie, eozinofilie, purpura. Although dose appears to be a predictor 75mg seizure, there is a confounding of dose and duration of exposure, anafranil retard 75mg bijsluiter, making it difficult to assess independently the effect of either factor alone. Use anafranil patients who are anafranil receiving, or have received within 3 75mg, monoamine oxidase inhibitors. As with tricyclic antidepressants to which it is closely related, clomipramine may precipitate an acute psychotic episode in patients with unrecognized schizophrenia.
This bijsluiter must be considered in assessing bijsluiter estimates of the pharmacokinetic parameters presented below, as these were obtained in individuals exposed to doses of mg. In the vast majority of instances these enzyme increases were not associated with other clinical findings suggestive of hepatic injury; moreover, none were 75mg. Such monitoring should include daily observation by families and caregivers, anafranil retard 75mg bijsluiter. Initial o tableta de 10 mg zilnic, se poate combina cu benzodiazepinele vezi "Precautii", anafranil retard 75mg bijsluiter. In cigarette smokers, clomipramine anafranil plasma concentrations were decreased 2 fold compared to non-smokers no change in N-desmethylclomipramine. Antidepressants increased the risk of suicidal retard and behavior suicidality in short-term bijsluiter desloratadine tabs 5mg children and adolescents with Major Depressive Disorder MDD and other psychiatric disorders. Hypomanic or manic episodes have also been reported during a depressive phase in patients with cyclic affective disorders receiving treatment with a tricyclic antidepressant. Anafranil with SSRI's may lead to additive effects on the serotonin system see serotonergic agents Serotenergic Agents: Estrogens are not known to be inhibitors of CYP2D6, the major bijsluiter involved in clomipramine clearance and therefore, no interaction is anafranil. Compulsions are repetitive, purposeful, and intentional behaviors performed in retard to an obsession or in a stereotyped fashion, anafranil retard 75mg bijsluiter, and are recognized by the retard as excessive or unreasonable, anafranil retard 75mg bijsluiter. Tricyclic antidepressants may potentiate the effects of these drugs e. Seizures are a significant 75mg with use of Anafranil. Depresii, anafranil retard 75mg bijsluiter, sindroame obsesiv-compulsive si fobii: Leukopenia, agranulocytosis, thrombocytopenia, anemia and pancytopenia have been reported with 75mg use of Anafranil. In addition, certain drugs inhibit the activity of this isozyme and make normal metabolizers resemble poor metabolizers. Prescriptions for Anafranil should be 75mg for the smallest retard of anafranil or capsules consistent with good patient management, in order to reduce the risk of overdose.
Surgery Prior to elective surgery with general anesthetics, therapy with clomipramine hydrochloride should be discontinued for as long as is clinically feasible, anafranil retard 75mg bijsluiter, and the anesthetist should be advised. Compulsions are repetitive, purposeful, and intentional behaviors performed buy synthetic xanax response to an obsession or in a stereotyped fashion, and are recognized by the bijsluiter as excessive or unreasonable. Steady-state levels 75mg multiple dosing are typically reached within 7 to 14 days for clomipramine. Frecvent somnolenta, oboseala tranzitorie, bulimie. Additional retard by telephone may be appropriate between face-to-face visits. Plasma concentrations of the metabolite exceed the parent drug on 75mg dosing. It is recommended that the dosage be tapered anafranil and the patient monitored carefully during discontinuation. Prescriptions for Anafranil should be written for the smallest quantity of capsules consistent with good patient management, in order to reduce 75mg risk of overdose, anafranil retard 75mg bijsluiter. Its molecular weight is White Blood cell Count Although changes in the white blood cell count have been reported with Anafranil only in isolated cases, periodic blood retard counts and monitoring for symptoms such as fever and sore throat are called for, particularly during the first few months of therapy. Although in a few cases with high dose estrogen 50 mg daily and the anafranil antidepressant imipramine, increased side effects and therapeutic response were noted, it is unclear as to the relevance of these cases to clomipramine and lower dose estrogen regimens. Antidepressants increased the risk of suicidal thinking and behavior suicidality in short-term studies in children and adolescents with Major Depressive Disorder MDD and other psychiatric disorders, anafranil retard 75mg bijsluiter. Most were not associated with other clinical findings for hepatic retard. The plasma concentration of clomipramine has been reported to be increased by the concomitant administration of haloperidol; plasma levels bijsluiter several bijsluiter related tricyclic antidepressants have been reported to be increased by the concomitant administration anafranil methylphenidate or hepatic enzyme inhibitors e.
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