Use
Therapeutic indications
- Major depressive episodes (that is, characterized).
- Rebel Algies.
- Neuropathic pain in adults.
Dosage and method of administration
- In children and adolescents, there is insufficient evidence of the efficacy and tolerance of TOFRANIL in the treatment of major depressive episodes and neuropathic pain.
The use of TOFRANIL in children and adolescents is not recommended in these indications.
- Use the appropriate doses of tablets (10 or 25 mg) depending on the prescribed daily dose.
DEPRESSION
- Dose:
The usual dose for the treatment of depression ranges from 75 to 150 mg per day.
The starting dose is usually 75 mg, but can be individually adjusted within the recommended dose range. This dose will eventually be reevaluated after 3 weeks of effective treatment at effective doses.
- Method of administration:
The pharmacokinetic characteristics of this medicine allow a single daily intake, during or outside meals. It may be necessary, depending on the case, to take the medication at the latest around 4 p.m., to prevent possible insomnia.
- Treatment duration:
Antidepressant treatment is symptomatic.
The treatment of an episode is several months (generally around 6 months) to prevent the risk of relapse of the depressive episode.
REBEL ALGIAS:
Retransmission of the injectable route: 3 to 6 tablets per day (i.e. 75 to 150 mg / day), or even more.
ADULT NEUROPATHIC PAIN:
Treatment should start with low doses: 10 to 25 mg per day. The dose is gradually increased, in increments of 10 to 25 mg each week, depending on tolerance. The dose is individual (25 to 300 mg / day), a daily dose of 25 to 75 mg is generally sufficient.
Maintenance therapy should be performed at the lowest effective dose, and the value of therapy should be reevaluated periodically.
POPULATIONS AT RISK:
- Aged subject:
Treatment will be started with low doses, that is, in practice with half the recommended minimum dose (see section on pharmacokinetic properties). The increase in doses, if necessary, will be gradual, through the practice of clinical monitoring: the undesirable effects of imipramines can have serious consequences in the elderly (falls, confusion).
- Patients with liver and kidney failure:
The dose should be reduced (see section on pharmacokinetic properties).
PROCESSING STOP:
Abrupt discontinuation or abrupt reduction of doses should be avoided due to the possible occurrence of withdrawal symptoms (see sections 4.4 and 4.8).
Information on discontinuation of treatment should also appear in warnings and precautions for use and adverse effects.
Prescription and delivery conditions
List I.
Duration and special precautions for conservation
Conversation duration:
5 years.
Special precautions for storage:
Keep away from moisture.
Preclinical safety data
Aimlessly.
Incompatibilities
Aimlessly.
Employment precautions
Contraindications
CONTRAINDICATED:
- This medicine should NEVER be prescribed in the following cases:
. hypersensitivity to imipramine or to any of the excipients;
. known risk of glaucoma when closing the angle;
. risk of urinary retention related to urethropropostatic disorders;
. recent myocardial infarction;
. combination with nonselective MAOIs (iproniazide, nialamide) and sultopride (see interactions section).
- Due to the presence of lactose and sucrose, this medicine is contraindicated in cases of congenital galactosemia, intolerance to fructose, malabsorption of glucose and galactose, lactase or sucrose deficiency. isomaltase
RECOMMENDED
- Lactation: the passage to breast milk is poorly understood but probably weak; however, as a precaution, breastfeeding should be avoided during treatment.
- Concomitant use of imipramine with MAOI-A (moclobemide, toloxatone), clonidine and guanfacine, alpha and beta sympathomimetics (epinephrine, norepinephrine, dopamine for systemic action by IM or IV route), linezolid is not recommended (see section of interactions).
- Concomitant intake of alcoholic beverages with imipramine should be avoided, as with any psychotropic medication.
Pregnancy and lactation
Pregnancy:
Maintaining a good maternal psychic balance is desirable throughout pregnancy. If medication management is necessary to ensure this balance, an effective dose should be instituted or continued throughout the pregnancy and, if possible, as monotherapy.
To date, the data appears to exclude a particular malformation risk from imipramine.
In newborns, signs of impregnation (particularly atropinic) and / or withdrawal have sometimes been described in mothers treated late in pregnancy with an antidepressant imipramine:
- neurological disorders in the first week of life (hypotonia, hyperexcitability, tremors or even exceptional seizures);
- respiratory disorders (polypnea, access to cyanosis, or even exceptional respiratory distress);
- digestive disorders (difficulty starting to eat, delayed meconium emission and bloating).
All of these signs appear in the first days of life and are often short-lived and mild.
Taking these data into account, the use of imipramine is possible regardless of the term of pregnancy. Newborn monitoring will take into account the effects described above.
Lactation:
The passage to breast milk is poorly understood but probably weak; however, as a precaution, breastfeeding should be avoided during treatment.
Warnings and precautions for use
PRECAUTIONS
- Use in children and adolescents under 18 years:
. Imipramine is not recommended for use in children and adolescents under 18 years of age. Suicidal behavior (suicide attempts and suicidal thoughts) and hostile behavior (mainly aggression, oppositional behavior, and anger) were observed more frequently during clinical studies in children and adolescents treated with antidepressants compared to those treated with placebo.
. If, in case of clinical need, the decision to treat is made, the patient should be carefully monitored for suicidal symptoms.
- Suicide / suicidal thoughts or clinical worsening:
. Depression is associated with an increased risk of suicidal thoughts, self-harm, and suicide. This risk persists until a significant remission is obtained. Since clinical improvement may not occur before several weeks of treatment, patients should be closely monitored until this improvement is achieved. Clinical experience shows that the risk of suicide may increase early in recovery.
. The other psychiatric conditions for which TOFRANIL is prescribed may also be associated with an increased risk of suicidal behavior. Furthermore, these disorders may be associated with a major depressive episode. Therefore, the same precautions for use as those mentioned for patients with major depressive episodes should be applied to patients with other psychiatric disorders.
. Patients with a history of suicidal behavior or those who express significant suicidal ideation before starting treatment are at increased risk of developing suicidal ideation or suicidal behavior, and should be monitored for closure during treatment. A meta-analysis of placebo-controlled clinical trials of antidepressant use in adults with psychiatric disorders has shown an increased risk of suicidal behavior in patients younger than 25 years treated with antidepressants compared to those receiving a placebo. Close monitoring of patients, and particularly those at high risk, should accompany pharmacological treatment, particularly at the start of treatment and during dose changes. Patients (and those around them) should be warned of the need to control clinical worsening, the onset of suicidal ideation / behavior and any abnormal changes in behavior and seek immediate medical advice if these symptoms occur.
- Other psychiatric effects:
. In some patients with a history of psychiatric disorders, it can be observed during treatment with tricyclic antidepressants:
* an increase in anxiety in patients with anxiety disorders (more pronounced in the first days of treatment and generally lasting in the first 2 weeks);
* reactivation of delirium in psychotic patients;
* hypomanic or manic episodes in patients with bipolar disorder. In the case of a frank and manic gyrus, treatment with imipramine will be discontinued and, in most cases, a sedative neuroleptic will be prescribed.
. Dose reduction may be necessary in some patients.
. In predisposed patients and the elderly, tricyclic antidepressants can cause confusional syndromes, especially at night, these disorders can also be promoted through the use of drugs with anticholinergic effects. These disorders generally disappear within a few days of stopping treatment.
- Cardiac and vascular disorders:
Imipramine should be used with caution in patients with cardiovascular conditions, especially patients with heart failure, cardiomyopathy and in the elderly due to tachycardia and hypotensive effects of this class of products.
An ECG is recommended at initial evaluation and blood pressure monitoring.
- Seizures:
Tricyclic antidepressants are known to lower the epileptogenic threshold, therefore TOFRANIL should be used with caution in patients with epilepsy or with risk factors for seizures and in concomitant electroconvulsive therapy. Since the risk of seizures depends on the dose, the maximum recommended dose of TOFRANIL should not be exceeded. The onset of seizures requires treatment discontinuation.
- Anticholinergic effects:
A decrease in lacrimal secretion and the accumulation of mucoid secretions due to the anticholinergic properties of tricyclic antidepressants can cause injury to the corneal epithelium in contact lens wearers.
- Special populations:
. When treating with tricyclic antidepressants, special attention should be paid to patients with severe hepatic or renal impairment or an adrenal gland tumor (eg Pheochromocytoma, neuroblastoma) for whom hypertensive crisis may occur.
. Caution should be exercised in patients with hyperthyroidism or should be treated with thyroid hormones (possible increase in cardiac adverse effects).
. Periodic monitoring of liver enzymes is recommended in patients with liver problems.
. Special attention should be paid to patients with chronic constipation, tricyclic antidepressants can cause paralytic ileus, especially in the elderly and bedridden.
. An increase in dental caries has been reported in long-term patients treated with tricyclic antidepressants. Therefore, regular dental check-ups are recommended.
- White blood cell count:
Changes in leukocyte formulation have only been reported in isolated cases with TOFRANIL, regular blood counts and monitoring of symptoms such as fever or angina are necessary, especially during the first months of treatment. They are also recommended for long-term treatment.
- Anesthesia:
Before any general or local anesthesia, the anesthesiologist must be informed that the patient is under treatment with TOFRANIL.
- Treatment stop:
Abrupt discontinuation or abrupt dose reduction should be avoided to prevent the onset of withdrawal symptoms. If the decision is made to discontinue treatment, it should be reduced very gradually, taking into account that sudden discontinuation may be associated with certain symptoms: headache, malaise, dizziness, nausea, anxiety, sleeping - (see side effects)
- Lactose - Sucrose:
Due to the presence of lactose and sucrose, this drug is contraindicated in cases of congenital galactosemia, fructose intolerance, glucose-galactose malabsorption syndrome, lactase or sucrase-isomaltase deficiency. .
- Pharmacological interactions:
Concomitant use of imipramine with MAOI-A (moclobemide, toloxatone), clonidine and guanfacine, alpha and beta sympathomimetics (epinephrine, norepinephrine, dopamine for systemic action IM or IV), linezolid is not recommended (see interactions section).
Concomitant intake of alcoholic beverages with imipramine should be avoided, as with any psychotropic medication.
EMPLOYMENT PRECAUTIONS:
- Insomnia or nervousness at the start of treatment may justify a reduction in dose or symptomatic transient treatment.
- In the case of a frank manic gyrus, treatment with imipramine will be discontinued and, in most cases, a sedative neuroleptic will be prescribed.
- In patients with epilepsy or with a history of epilepsy, it is prudent to strengthen clinical and electrical monitoring, due to the possibility of reducing the epileptogenic threshold. The onset of seizures requires treatment discontinuation.
- Imipramine should be used with caution:
. in the elderly with:
* increased sensitivity to hypotension and orthostatic sedation;
* chronic constipation (risk of paralytic ileus);
* a possible prostatic hypertrophy;
. in subjects with certain cardiovascular conditions, due to quinidine, tachycardia and the hypotensive effects of this class of products;
. in liver and kidney failure, due to the risk of overdose (see section on pharmacokinetic properties).
- Pregnancy: in newborns, of mothers treated in late pregnancy with an antidepressant imipramine, signs of impregnation (particularly atropinic) and / or withdrawal have sometimes been described: neurological disorders in the first week of life (hypotonia, hyperexcitability , tremors, or even seizures exceptionally); respiratory disorders (polypnea, access to cyanosis, or even exceptional respiratory distress); digestive disorders (difficulty starting to eat, delayed meconium emission, and bloating). All of these signs appear in the first days of life and are often short-lived and mild. Newborn monitoring will take into account the effects described above.
Interaction with other medicinal products and other forms of interaction
CONTRAINDICATED ASSOCIATIONS (see section on contraindications):
- Non-selective MAOIs:
Risk of developing serotonin syndrome *.
Respect a period of two weeks between discontinuation of MAOI and the start of treatment with the serotonergic antidepressant, and at least one week between discontinuation of the serotonergic antidepressant and the start of treatment with MAOI.
* Serotonin syndrome:
Certain overdoses or certain medications (lithium) can lead to a serotonin syndrome that justifies the immediate cessation of treatment.
Serotonin syndrome is manifested by the simultaneous or sequential (possibly sudden) onset of a set of symptoms that may require hospitalization or even death.
These symptoms can be of order:
. psychic (agitation, confusion, hypomania, possibly coma),
. vegetative (hypo or hypertension, tachycardia, chills, hyperthermia, sweating),
. motors (myoclonus, tremors, hyperreflexia, rigidity, hyperactivity),
. digestive (diarrhea).
Strict compliance with the recommended doses is an essential factor to prevent the appearance of this syndrome.
- Sultopride:
Increased risk of ventricular rhythm disturbances, especially torsade de pointes.
RECOMMENDED ASSOCIATIONS (see section warnings and precautions for use):
- Clonidine, guanfacine:
Inhibition of the antihypertensive effect of clonidine or guanfacine (antagonism at the level of adrenergic receptors).
- Selective MAOI A (moclobemide, toloxatone):
Risk of developing serotonin syndrome *.
(watch up)
If the association is necessary, very close clinical surveillance. Begin the association with the minimum recommended doses.
- Linzolid:
Risk of developing serotonin syndrome *. If the combination cannot be avoided, very close clinical surveillance. Begin the association with the minimum recommended doses.
- Alpha and beta sympathomimetics (route IM and IV):
Paroxysmal hypertension with the possibility of arrhythmia (inhibition of sympathomimetic entry into the sympathetic fiber).
ASSOCIATIONS SUBJECT TO EMPLOYMENT PRECAUTIONS:
- Selective serotonin reuptake inhibitors:
Increased plasma concentrations of the antidepressant imipramine with risk of seizures and increased side effects.
In case of association, greater clinical monitoring and, if necessary, dose adjustment.
- Adrenaline (oral or subcutaneous route):
Severe disturbances of ventricular rhythm due to increased cardiac excitability.
Limit intake, for example, less than 0.1 mg adrenaline in 10 minutes or 0.3 mg in one hour in adults.
- Thioridazine (neuroleptic phenothiazine):
Risk of greater adverse effects of imipramines, by decreasing their liver metabolism by thioridazine.
Clinical monitoring: if necessary, dose adjustment of antidepressants during thioridazine treatment.
ASSOCIATIONS TO TAKE INTO ACCOUNT:
- Antihypertensive drugs:
Increased risk of hypotension, especially orthostatic.
- Atropine and other atropine substances: sedative antihistamines H1, anticholinergic antiparkinsonians, atropine antispasmodics, disopyramide, phenothiazine neuroleptics.
Adding atropine side effects like urinary retention, constipation, dry mouth ...
- Other drugs that lower the epileptogenic threshold:
The joint use of proconvulsive drugs, or the reduction of the epileptogenic threshold, must be carefully weighed, due to the seriousness of the risk. These drugs are represented in particular by most antidepressants (imipramines, selective serotonin reuptake inhibitors), neuroleptics (phenothiazines and butyrophenones), mefloquine, bupropion, tramadol.
Increased risk of seizures.
- Baclofen:
Risk of increased muscle hypotonia.
- Beta-blockers in heart failure:
Vasodilator effect and risk of hypotension, especially orthostatic (additive effect).
- Nitrates and related derivatives:
Increased risk of hypotension, especially orthostatic.
Caution
Undesirable effects
- It can be difficult to distinguish certain side effects from certain symptoms of depression.
Elderly patients are particularly sensitive to anticholinergic, neurological, mental or cardiovascular effects. Its ability to metabolize and eliminate drugs may be reduced, which carries a risk of increased plasma concentrations at therapeutic doses.
- The unwanted effects (Table 1) are classified by frequency category, the most frequent first, using the following convention: very frequent (more = 1/10); common (plus = 1/100, minus 1/10); uncommon (plus = 1/1000, minus 1/100); rare (plus = 1/10000, minus 1/1000); Very rare (less than 1/10000), including isolated cases.
TABLE 1.
- Infections and infestations:
Very rare: dental caries.
- Blood and lymphatic system disorders:
Very rare: leukopenia, agranulocytosis, eosinophilia, thrombocytopenia.
- Immune system disorders:
Very rare: anaphylactic reaction.
- Endocrine disorders:
Very rare: inappropriate secretion of antidiuretic hormone.
- Metabolism and nutrition disorders:
. Rare: weight gain.
. Very rare: anorexia, increased blood sugar, decreased blood sugar, weight loss.
- Psychiatric disorders:
. Common: nervousness, confusion, delirium, hallucinations, anxiety, restlessness, mania, hypomania, libido disorders, sleep disorders, disorientation.
. Rare: psychotic disorder.
. Very rare: assault.
. Frequency not known: suicidal ideation and behavior.
- Disorders of the nervous system:
. Very common: tremor.
. Common: dizziness, headache, daytime sleepiness, paresthesia.
. Uncommon: myoclonus.
. Rare: seizures, extrapyramidal disorder, ataxia.
. Very rare: dysarthria, electroencephalogram abnormalities, serotonergic syndrome (in combination).
- Eye disorders:
. Common: blurred vision, accommodation disorders, decreased tear discharge.
. Uncommon: mydriasis.
. Very rare: glaucoma.
- Ear and labyrinth disorders:
Very rare: tinnitus.
- Heart conditions:
. Very common: sinus tachycardia.
. Common: arrhythmias, conduction disorders.
. Very rare: heart failure, syncope, ventricular arrhythmia.
- Vascular disorders:
. Very common: hot flashes, orthostatic hypotension.
. Very rare: purpura, petechiae, vasospasm, increased blood pressure.
- Respiratory, thoracic and mediastinal disorders:
Very rare: allergic alveolitis (with or without eosinophilia).
- Gastrointestinal disorders:
. Very common: dry mouth, constipation.
. Uncommon: nausea, vomiting.
. Very rare: paralytic ileus, ulceration of the tongue, stomatitis.
- Hepatobiliary disorders:
. Common: abnormal liver function tests.
. Very rare: hepatitis (with or without jaundice).
- Skin and subcutaneous tissue disorders:
. Common: allergic dermatitis, skin rash.
. Uncommon: hyperhidrosis.
. Rare: Urticaria.
. Very rare: pruritus, photosensitivity reaction, alopecia, skin hyperpigmentation.
- Renal and urinary tract disorders:
. Common: urination disorders.
. Very rare: urinary retention.
- Conditions of the reproductive organs and the breasts:
Very rare: gynecomastia, galactorrhea.
- Cases of suicidal ideation and behavior have been reported during or shortly after treatment with TOFRANIL (see Warnings and Precautions for Use section).
- Withdrawal symptoms when treatment is stopped:
Stopping imipramine treatment, especially when it is abrupt, can cause withdrawal symptoms.
Observed: sleep disorders, anxiety, dizziness, nausea, headache, general malaise. Therefore, it is recommended to gradually reduce the doses of imipramine when treatment is no longer necessary (see sections on dosage and method of administration and warnings and precautions for use).
- Cases of impotence have also been observed.
- Very rare cases of cardiomyopathy have been reported.
- Effects related to the nature of depressive illness itself:
. lifting of psychomotor inhibition, with suicidal risk,
. change of mood with the appearance of manic episodes,
. reactivation of delirium in psychotic subjects,
. paroxysmal manifestations of anxiety.
Overdose
The signs and symptoms of a TOFRANIL overdose are similar to those reported with other tricyclic antidepressants. The main complications are cardiac and neurological.
Accidental ingestion in children should be considered serious and life-threatening.
- Signs and symptoms:
. Symptoms generally appear within 4 hours of ingestion and peak at 24 hours. Given the delay in absorption (anticholinergic effect), the long half-life and the enterohepatic passage, the patient can remain at risk for up to 4 to 6 days.
. The following signs and symptoms may appear:
* Central nervous system: drowsiness, stupor, coma, ataxia, nervousness, agitation, increased reflexes, muscle stiffness, choreoathetosic movements, seizures.
* Cardiovascular system: hypotension, tachycardia, arrhythmias, conduction disorders, shock, heart failure, ventricular tachycardia, ventricular fibrillation, torsades de pointes, cardiac arrest, some of these events had a fatal outcome.
. In addition, respiratory depression, cyanosis, vomiting, fever, mydriasis, sweating, and oliguria or anuria may occur.
. Isolated cases of QT prolongation, torsade de pointes, and death have been reported.
- Treatment:
. In the absence of a specific antidote, treatment will be primarily symptomatic with the necessary supportive measures.
Patients, especially children, who have ingested an excessive dose of TOFRANIL should be hospitalized and kept under close supervision for at least 72 hours.
Gastric emptying will be carried out as soon as possible, either by stomach lavage or vomiting caused if the patient is conscious. If the patient is unconscious, a balloon endotracheal tube will be used to protect the airways before gastric lavage, and the patient will not be vomited. These measures are recommended for up to 12 hours or even more after an overdose, since the anticholinergic effect of the medicine can delay gastric emptying. Administration of activated carbon can help reduce the absorption of the drug.
. Symptomatic treatment will use current intensive care methods, with continuous monitoring of cardiac function, blood gases and electrolytes, as well as the possible use of emergency measures, such as anticonvulsant therapy, artificial respiration and resuscitation. Physostigmine has caused severe bradycardia, asystole and seizures, therefore its use is not recommended in case of TOFRANIL overdose. Hemodialysis or peritoneal dialysis is of no use due to low plasma TOFRANIL concentrations.
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