The following adverse effects have been reported with Tofranil or other tricyclic antidepressants.
CNS:
Frequently: Tremors. Occasionally: drowsiness, fatigue, insomnia, dizziness, headache, paresthesia (numbness, tingling sensation, symptoms suggestive of peripheral neuropathy). Rarely: Epileptic seizures. In isolated cases: Tinnitus, incoordination, ataxia, alterations in EEG patterns, extrapyramidal symptoms, myoclonus, speech disorders.
Behavioral:
Occasionally: Confusional states (especially in the elderly) with hallucinations, disorientation, delusions, anxiety, agitation, restlessness, nightmares, hypomania, mania, exacerbation of psychosis, decrease in memory, feeling of unreality. In isolated cases: Feeling of weakness, aggressiveness.
Autonomic:
Frequently: Dry mouth and rarely associated sublingual adenitis, blurred vision, disturbances of accommodation, constipation, perspiration, flushing. Occasionally: Delayed micturition, dilation of the urinary tract. In isolated cases: Mydriasis, glaucoma, paralytic ileus, urinary frequency.
Cardiovascular:
Frequently: Hypotension, particularly orthostatic hypotension with associated vertigo, tachycardia, ECG changes (including flattening or inversion of T wave). Occasionally: Arrhythmia, disturbances in cardiac conduction, palpitation, syncope. In isolated cases: Hypertension, congestive heart failure, myocardial infarction, heart block, asystole, stroke, peripheral vasospastic reactions.
Hematologic:
In isolated cases: Agranulocytosis, eosinophilia, leukopenia, purpura and thrombocytopenia may occur as an idiosyncratic response.
Gastrointestinal:
Occasionally: Nausea, vomiting, anorexia. Rarely: Elevated transaminases. In isolated cases: Diarrhea, bitter taste, stomatitis, epigastric distress, abdominal cramps, black tongue, dysphagia, increased salivation, hepatitis with or without jaundice.
Endocrine:
Frequently: Weight gain. Occasionally: Increased or decreased libido, impotence. In isolated cases: Gynecomastia in the male, breast enlargement and galactorrhea in the female, testicular swelling, elevation or depression of blood sugar levels, weight loss, inappropriate antidiuretic hormone (ADH) secretion syndrome.
Allergic or Toxic:
Occasionally: Skin rash, urticaria. In isolated cases: Petechiae, itching, photosensitization (avoid excessive exposure to sunlight), edema (general or of face and tongue), drug fever, obstructive jaundice, nasal congestion, alopecia, cross-sensitivity with desipramine, allergic alveolitis (pneumonia) with or without eosinophilia.
If treatment is terminated abruptly, withdrawal symptoms, such as gastrointestinal upsets, nervousness, anxiety, and muscle twitching may occur.
Overdose
Children have been reported to be more sensitive than adults to an acute overdosage of Tofranil. An acute overdose in infants or young children must be considered serious and potentially fatal.
Symptoms:
These may vary in severity depending upon factors such as the amount of drug absorbed, the age of the patient and the interval between drug ingestion and the start of treatment. Blood and urine levels of Tofranil may not reflect the severity of poisoning; they have chiefly a qualitative rather than quantitative value, and are unreliable indicators in the clinical management of the patient.
Drowsiness, stupor, ataxia, vomiting, cyanosis, restlessness, agitation, delirium, severe perspiration, hyperactive reflexes, muscle rigidity, athetoid movements, convulsions, respiratory depression, hyperpyrexia, hypothermia, mydriasis, and bowel and bladder paralysis may occur.
Serious cardiovascular disturbances are frequently present, including tachycardia, cardiac arrhythmia (flutter, atriofibrillation, ventricular premature beats, and ventricular tachycardia), as well as impaired myocardial conduction, atrioventricular and intraventricular block, ECG abnormalities (such as widened QRS complexes and marked S-T shifts and signs of congestive heart failure and cardiac arrest). Hypotension and initial hypertension may occur. However, the usual finding is increasing hypotension which may lead eventually to shock. Coma may ensue.
Treatment:
Symptomatic and supportive. Cardiac arrhythmias and CNS involvement pose the greatest threat with tricyclic antidepressant overdosage and may occur suddenly even when initial symptoms appear to be mild. Therefore, patients who may have ingested an overdosage of Tofranil, particularly children, should be hospitalized and kept under close surveillance.
If the patient is conscious, induced emesis followed by gastric lavage, with appropriate precautions to prevent pulmonary aspiration, should be accomplished as soon as possible. Following lavage, activated charcoal may be administered to reduce absorption. An adequate airway should be established in comatose patients and assisted ventilation instituted, if necessary, but respiratory stimulants should not be used. Hyperpyrexia should be controlled by external measures, such as ice packs and cooling sponge baths. Acidosis may be treated by cautious administration of sodium bicarbonate. Adequate renal function should be maintained.
External stimulation should be minimized to reduce the tendency to convulsions. If convulsions occur, anticonvulsants (preferably i.v. diazepam) should be administered. Barbiturates may intensify respiratory depression, particularly in children, and aggravate hypotension and coma. Paraldehyde may be used in some children to counteract muscular hypertonus and convulsions with less likelihood of causing respiratory depression. If the patient fails to respond rapidly to anticonvulsants, artificial ventilation should be instituted. Prompt control of convulsions is essential since they aggravate hypoxia and acidosis and may thereby precipitate cardiac arrhythmias and arrest.
ECG monitoring in an intensive care unit is recommended in all patients, particularly in the presence of ECG abnormalities, and should be maintained for several days after the cardiac rhythm has returned to normal. A patient who has ingested a toxic overdose of a tricyclic antidepressant may remain medically and psychiatrically unstable for several days due to sustained excessive drug levels. Unexpected cardiac deaths have occurred up to 6 days after overdosage with other antidepressants. The QRS interval of the electrocardiogram appears to be a reliable correlate of the severity of overdosage. If the QRS interval exceeds 100 milliseconds any time during the first 24 hours after overdosage, cardiac function should be continuously monitored for 5 or 6 days. Correction of hypoxia, if present, may be beneficial. Correction of metabolic acidosis and low potassium concentrations by means of bicarbonate i.v. and potassium substitution may also be effective for treatment for arrhythmia. If bradyarrhythmia or AV-block occur, consider temporary insertion of a cardiac pacemaker. Because of its effect on cardiac conduction, digitalis should be used only, with caution. If rapid digitalization is required for the treatment of congestive heart failure, special care should be exercised in using the drug.
Shock should be treated with supportive measures such as i.v. fluids, plasma expanders, oxygen and corticosteroids. Hypotension usually responds to elevation of the foot of the bed. Pressor agents, such as norepinephrine (but not epinephrine), are rarely indicated and should be given only after careful consideration and under continuous monitoring. In the event of a reduced myocardial function, consider recourse to treatment with dopamine or dobutamine by i.v. drip.
Physostigmine i.v. has been used in the treatment of tricyclic-induced anticholinergic toxicity. Its use is controversial and should be reserved for life-threatening situations. Physostigmine is not innocuous and carries the risk of inducing seizures, bronchospasm, hypertension and severe arrhythmias. It should not be used routinely or to reverse coma. However, it may be indicated in the treatment of seizures or combative hallucinations. It should not be used in patients who are acidemic or who have cardiac conduction defects.
Adults:
A test dose of 0.5 mg i.v. is given initially. Give 1 to 2 mg slowly i.v. (over 2 minutes). If no clinical changes or cholinergic signs occur within 15 to 30 minutes, an additional 1 to 2 mg may be cautiously administered. Repeat doses of 1 to 2 mg i.v. every 30 minutes up to 2 hours.
Children:
0.5 mg i.v. is given initially.
As the CNS effects of physostigmine may wear off rapidly, it is important to monitor the patient continuously.
Physostigmine is the only drug of this class that may be used. Neostigmine should not be used as it does not have any CNS effects.
If symptoms of cholinergic toxicity develop, physostigmine should be discontinued.
Peritoneal and hemodialysis are of no value because of low plasma concentrations of the drug. Most of the administered dose is distributed in tissue and not in plasma. When aggressive medical management is inadequate, hemoperfusion, but not hemodialysis, has shown some good results.
Deaths by deliberate or accidental overdosage have occurred with this class of drugs. Since the propensity for suicide is high in depressed patients, a suicide attempt by other means may occur during the recovery phase. The possibility of simultaneous ingestion of other drugs should also be considered.
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