Index
This medicine is used primarily to change unbalanced chemicals in the brain of people suffering from depression.
Tryptanol is a tricyclic antidepressant. This medicine may also be used for other purposes not mentioned in this guide.
Tryptanol is used to treat the following conditions:
- Depression (especially with anxiety, agitation and sleep disorders, organic brain damage, alcohol withdrawal, etc.).
- Schizophrenic psychoses.
- I mixed emotional disorders.
- Behavioral disorders (activity and attention).
- Nocturnal enuresis (except in patients with hypotonia of the bladder).
- Bulimia nervosa
- Chronic pain syndrome (chronic pain in cancer patients, migraine, rheumatic pain, atypical facial pain, postherpetic neuralgia, post-traumatic neuropathy, diabetic neuropathy, peripheral neuropathy).
- Migraine prevention.
- Peptic ulcer.
- Ultra duodenal.
Tryptanol Administration
Use Tryptanol as directed by your doctor. Check the drug label for exact dosing instructions.
- Tryptanol comes with an additional patient information sheet called a Medication Guide. Please read it carefully and reread it each time you refill the Tryptanol.
- Tryptanol can be taken with food or on an empty stomach.
- Tryptanol can take up to 30 days to control the symptoms of depression. Even if you feel fine, you should continue taking medicine and not miss any doses.
- Take the missed dose of Tryptanol as soon as possible, but if it is almost time to start using the medicine again, only take one amount.
Tryptanol dosage
Oral dose
The oral dose of the drug at the beginning should be minimal and gradually increase, taking into account any reaction and evidence of intolerance related to the consumption of the drug.
Starting dose for adults
75 mg of Tryptanol HCl daily in divided doses for outpatients is generally satisfactory. If necessary, this can be increased to 150 mg per day. In the late afternoon and at bedtime, increases are made.
A sedative effect may appear before the antidepressant effect is noticeable, but an adequate therapeutic effect may take up to 30 days.
An alternate method of starting outpatient treatment is to start with 50 to 100 mg of Tryptanol HCl before bedtime. This can be increased by 25 or 50 mg, as needed, at the bedtime dose, up to 150 mg per day.
Hospitalized patients may initially require 100 mg per day. This can be gradually increased to 200 mg a day if necessary. A small number of hospitalized patients may need as much as 300 mg per day.
Adolescent and elderly patients
Lower doses are generally recommended for these patients. 10 mg 3 times a day with 20 mg at bedtime may be satisfactory in adolescent and elderly patients who cannot tolerate higher doses.
Maintenance
The usual maintenance dose of Tryptanol HCl is 50 to 100 mg per day. In some patients, 40 mg per day is sufficient. The total daily dosage can be administered in a single dose for maintenance therapy, preferably at bedtime.
When satisfactory improvement has been achieved, the dose should be reduced to the lowest amount that maintains relief from symptoms. It is appropriate to continue maintenance therapy for three months or more to decrease the possibility of relapse.
Use in pediatric patients.
Given the lack of experience with using this medicine in pediatric patients, it is not currently recommended for patients under 12 years of age.
Plasma levels
It is difficult to directly correlate plasma levels and therapeutic effects because of the wide variation in the absorption and distribution of tricyclic antidepressants in body fluids.
In patients who appear to have toxic effects and may have excessively high levels or in those in whom it is suspected that there is a lack of absorption and development of the drug in their bodies, the determination of plasma levels can be beneficial.
Due to increased intestinal transit time and decreased hepatic metabolism in elderly patients, plasma levels are generally higher for a given oral dose of Tryptanol hydrochloride than in younger patients.
Elderly patients should be carefully monitored, and quantitative serum levels should be obtained as clinically appropriate. Dosage adjustments should be made not to the function of plasma levels but the clinical response of the patient.
Interactions with Tryptanol
When this medicine is applied simultaneously with:
- Drugs have a depressing effect on the central nervous system: there may be a significant increase in the inhibitory action on the central nervous system, hypotensive effect, and respiratory depression.
- Medicines with anticholinergic activity: can increase anticholinergic effects. It can enhance the action of sympathomimetic funds for the cardiovascular system and increase the risk of cardiac arrhythmia, tachycardia, and severe hypertension.
- Antipsychotic drugs (neuroleptics): are a relatively suppressed metabolism, reducing the threshold of seizure readiness.
- Antihypertensive drugs (except clonidine, guanethidine, and derivatives): can increase the antihypertensive action and the risk of orthostatic hypotension.
- With MAO inhibitors: a hypertensive crisis can develop.
- With clonidine, guanethidine: can decrease the hypotensive effect of clonidine or guanethidine.
- With barbiturates and carbamazepine: You can decrease the action of Tryptanol by increasing your metabolism.
- Sucralfate: decreases the absorption of Tryptanol.
- Fluvoxamine: increases the concentration of Tryptanol in the blood plasma and the risk of toxic effects;
- With fluoxetine: increased Tryptanol concentration in plasma and development of toxic reactions due to inhibition of the isoenzyme CYP2D6 under the influence of fluoxetine.
- Quinidine: it can slow down the metabolism of Tryptanol.
- Cimetidine: it can slow down the metabolism of Tryptanol, increasing its concentration in the blood plasma and developing toxic effects.
When drinking alcohol, the action of ethanol increases, especially during the first days of therapy.
A case of serotonin syndrome with simultaneous use with sertraline was described.
Side effects of Tryptanol
Within each category, the following adverse reactions are listed in order of decreasing severity.
Cardiovascular: myocardial infarction, nonspecific ECG changes and AV conduction changes, heart block, arrhythmias, hypotension (particularly orthostatic hypotension ), syncope, hypertension, tachycardia, palpitations.
SNC y neuromuscular:
- Coma.
- Seizures
- Hallucinations
- Confusional states.
- Disorientation.
- Incoordinación.
- Ataxia.
- Tremors
- Peripheral neuropathy.
- Numbness.
- Tingling and paresthesias of the extremities.
- Extrapyramidal symptoms include abnormal involuntary movements and tardive dyskinesia.
- Dysarthria.
- Disturbed concentration.
- Anxiety.
- Insomnia.
- Restlessness.
- Nightmares.
- Drowsiness.
- Dizziness.
- Soft spot.
- Fatigue.
- Headache.
- Syndrome of inappropriate ADH (antidiuretic hormone) secretion.
- Tinnitus.
- Alteration in EEG patterns.
Anticholinergic: paralytic ileus, hyperpyrexia, urinary retention, dilation, constipation, blurred vision, impaired accommodation, increased eye pressure, mydriasis, dry mouth.
Hematologic: bone marrow depression including agranulocytosis, leukopenia, thrombocytopenia, purpura, eosinophilia.
Allergic: urticaria, photosensitization, skin rash, edema of the face and tongue.
Gastrointestinal: rarely hepatitis (including impaired liver function and jaundice), nausea, epigastric distress, vomiting, anorexia, stomatitis, peculiar taste, diarrhea, parotid swelling, black tongue.
Endocrine: Testicular swelling and gynecomastia in men, breast enlargement, and galactorrhea in women increased or decreased libido, impotence, elevation, and blood sugar levels.
Other: Alopecia, edema, weight gain or loss, urinary frequency, increased perspiration.
Withdrawal symptoms
After prolonged administration, abrupt cessation of treatment may cause nausea, headache, and general malaise. Gradual dose reduction produces transient symptoms such as sleep disturbances, irritability, and restlessness after two weeks of dose reduction.
Rare cases of mania or hypomania have been reported to occur within 2 to 7 days after cessation of chronic tricyclic antidepressant therapy.
Unknown causal relationship
Other reactions, reported under circumstances where a causal relationship could not be established, are listed to serve as alert information to clinicians:
- Body in general: lupus-like syndrome (migratory arthritis, positive ANA, and rheumatoid factor).
- Digestive: liver failure, ageusia.
Post-marketing adverse events
A syndrome resembling neuroleptic malignant syndrome (NMS) has rarely been reported after starting or increasing the dose of Tryptanol hydrochloride, with and without concomitant medications known to cause NMS.
Symptoms have included: muscle stiffness, fever, changes in mental status, sweating, tachycardia, and tremor.
Sporadic cases of serotonin syndrome (SS) have been reported with Tryptanol hydrochloride in combination with other medicinal products that have a recognized association with SS.
Tryptanol contraindications
Tryptanol hydrochloride is contraindicated in patients who have shown the previous hypersensitivity.
It should not be administered concomitantly with monoamine oxidase inhibitors. In patients receiving tricyclic antidepressants and monoamine oxidase inhibitor drugs simultaneously, hyperpyretic seizures, severe seizures, and deaths.
A minimum of 14 days should be allowed after stopping the first when it is desired to replace a monoamine oxidase inhibitor with Tryptanol hydrochloride.
Treatment with this medicine should be started with great caution, gradually increasing the Tryptanol dosage until an optimal response is achieved.
Tryptanol hydrochloride should not be administered with cisapride due to the possibility of an increased QT interval and an increased risk of arrhythmia.
