Brand Name: Asendin
Amoxapine is a tricyclic antidepressant used to treat depression. Detailed info on uses, dosage and side-effects of Amoxapine below.
Contents:
Description
Pharmacology
Indications and Usage
Contraindications
Warnings
Precautions
Drug Interactions
Adverse Reactions
Overdose
Dosage
Supplied
Amoxapine (Asendin) is a tricyclic antidepressant used to treat depression.
The mechanism of clinical action of amoxapine in man is not well understood.
Amoxapine is not a monoamine oxidase (MAO) inhibitor. In animals, amoxapine
inhibits the re-uptake of norepinephrine and, to a lesser degree, of serotonin,
at adrenergic nerve endings and blocks the response of dopamine receptors to
dopamine.
Amoxapine (Asendin) is absorbed rapidly and reaches peak blood levels
approximately 90 minutes after ingestion.
Relieves the symptoms of depression.
The use of amoxapine or other tricyclic antidepressants concurrently with a
monoamine oxidase (MAO) inhibitor is contraindicated. Hyperpyretic crises,
severe convulsions, and fatalities have occurred when similar tricyclic
antidepressants were used in such combinations. It is advisable to have
discontinued the MAO inhibitor for at least two weeks before treatment with
amoxapine is started.
Patients hypersensitive to amoxapine should not be given the drug.
Cross-sensitivity between amoxapine and other dibenzazepines is a possibility.
Amoxapine is contraindicated during the acute recovery period after myocardial
infarction.
Tardive Dyskinesia: Tardive dyskinesia is known to occur in patients treated
with neuroleptics with antipsychotic properties and other drugs with substantial
neuroleptic activity. It has also been observed with amoxapine administration.
Although the dyskinetic syndrome may remit partially or completely if the
medication is withdrawn, it is irreversible in some patients. At the present
time there is uncertainty as to whether neuroleptic drugs differ in their
potential to cause tardive dyskinesia.
Since there is a significant prevalence of this syndrome associated with the use
of neuroleptic drugs, and since there is no known effective treatment, chronic
use of these drugs should generally be restricted to patients for whom
neuroleptics are known to be effective and for whom there is no alternative
therapy available with better risk acceptability. If manifestations of tardive
dyskinesia are detected during the use of amoxapine, the drug should be
discontinued. The risk of a patient developing tardive dyskinesia and of the
syndrome becoming irreversible appear to increase with the duration of treatment
and the total amount of drugs administered, although, in some instances, tardive
dyskinesia may develop after relatively short periods of treatment at low doses.
The risk of developing tardive dyskinesia may, therefore, be minimized by
reducing the dose of the neuroleptic drug used and its duration of
administration, consistent with the effective management of the patient's
condition. Continued use of neuroleptics should be periodically reassessed.
Cardiovascular: Patients with cardiovascular disease should be given
amoxapine only under close supervision because of the tendency of the drug to
produce sinus tachycardia and to prolong the conduction time. Myocardial
infarction, arrhythmia, and strokes have occurred. The antihypertensive action
of guanethidine and similar agents may be blocked. Because of its
anticholinergic activity, use amoxapine with great caution in patients with
glaucoma or a history of urinary retention. Patients with a history of seizures
should be followed closely when amoxapine is administered because this drug is
known to lower the convulsive threshold. Great care is required if amoxapine is
administered to hyperthyroid patients or those receiving thyroid medication,
because cardiac arrhythmias may develop.
Interference with Cognitive or Motor Performance: Amoxapine may impair
the mental and/or physical abilities required for the performance of hazardous
tasks, such as operating machinery or driving a car; therefore, the patient
should be warned accordingly.
Excessive consumption of alcohol in combination with amoxapine therapy may have
a potentiating effect, which may lead to the danger of increased suicidal
attempts or overdosage, especially in patients with histories of emotional
disturbances or suicidal ideation.
Usage in Pregnancy
Safe use of amoxapine during pregnancy and lactation has not been established;
therefore, when the drug is administered to pregnant patients, nursing mothers,
or women of childbearing potential, the potential benefits must be weighed
against the possible hazards. Animal reproduction studies have yielded
inconclusive results.
Usage in Children: This drug is not recommended for use in children,
since safety and effectiveness in the pediatric age group have not been
established.
The use of amoxapine in schizophrenic patients may result in an exacerbation of
the psychosis or may activate latent schizophrenic symptoms. If the drug is
given to overactive or agitated patients, increased anxiety and agitation may
occur. In manic depressive patients, amoxapine may cause symptoms of the manic
phase to emerge.
Amoxapine may cause increased sensitivity to the sun. Avoid exposure to the sun,
sunlamps, or tanning booths until you know how you react to this medicine. Use a
sunscreen or protective clothing if you must be outside for a prolonged period.
Troublesome patient hostility may be aroused by the use of amoxapine.
Epileptiform seizures may accompany its administration, as may happen with other
drugs of its class.
Close supervision and careful adjustment of the dosage are required when
amoxapine is used with other anticholinergic drugs and sympathomimetic drugs.
When possible, the drug should be discontinued several days before elective
surgery.
The possibility of a suicidal attempt by a depressed patient remains after the
initiation of treatment; in this regard, it is important that the least possible
quantity of drug be dispensed at any given time.
Both elevation and lowering of blood sugar levels have been reported.
Caution should be exercised if amoxapine is administered together with
cimetidine since cimetidine inhibits tricyclic antidepressant metabolism, and
clinically significant increases in plasma levels of amoxapine may occur.
Drug Interactions
Administration of reserpine during therapy with a tricyclic antidepressant has
been shown to produce a "stimulating" effect in some depressed patients.
Close supervision and careful adjustment of the dosage are required when
amoxapine is used with other anticholinergic drugs and sympathomimetic drugs.
Concurrent administration of cimetidine and tricyclic antidepressants can
produce clinically significant increases in the plasma concentrations of the
tricyclic antidepressant. The patient should be informed that the response to
alcohol may be exaggerated.
Amoxapine may enhance the response to alcohol and the effects of barbiturates
and other CNS depressants. Delirium has been reported with concurrent
administration of amoxapine and disulfiram.
BEFORE USING THIS MEDICINE: INFORM YOUR DOCTOR OR
PHARMACIST of all prescription and over-the-counter medicine that you are
taking. This includes carbamazepine, cimetidine, dicumarol, clonidine,
mibefradil, paroxetine, tramadol, other medicines for depression or emotional
disorders, and medicines for seizures. Inform your doctor of any other medical
conditions including heart conditions, allergies, pregnancy, or breast-feeding.
Stop taking this medicine and get emergency help immediately if any of the
following side effects occur: Convulsions (seizures); difficult or fast
breathing; fever with increased sweating; high or low (irregular) blood
pressure; loss of bladder control; muscle stiffness (severe); lip smacking or
puckering; uncontrolled chewing movements; or uncontrolled movements of hands,
arms, or legs; pale skin; unusual severe tiredness or weakness.
NOTE: Some of the adverse reactions noted below have not been
specifically reported with amoxapine use. However, due to the close
pharmacological similarities among the tricyclics, the reactions should be
considered when prescribing amoxapine. Within each category the following
adverse reactions are listed in order of decreasing severity.
Cardiovascular: Hypotension, hypertension, tachycardia, palpitation,
myocardial infarction, arrhythmias, heart block, stroke.
Psychiatric: Confusional states (especially in the elderly) with
hallucinations, disorientation, delusions; anxiety, restlessness, agitation;
insomnia, panic, nightmares; hypomania; exacerbation of psychosis.
Neurologic: Numbness, tingling, paresthesias of extremities;
incoordination, ataxia, tremors; peripheral neuropathy; extrapyramidal symptoms;
seizures, alteration in EEG patterns; tinnitus.
Anticholinergic: Dry mouth and, rarely, associated sublingual adenitis;
blurred vision, disturbance of accommodation, mydriasis; constipation, paralytic
ileus; urinary retention, delayed micturition, dilation of the urinary tract.
Allergic: Skin rash, petechiae, urticaria, itching, photosensitization
(avoid excessive exposure to sunlight); edema (general or of face and tongue),
drug fever, cross-sensitivity with other tricyclic drugs.
Hematologic: Bone marrow depression, including agranulocytosis;
eosinophilia; purpura; thrombocytopenia.
Gastrointestinal: Nausea and vomiting, anorexia, epigastric distress,
diarrhea, peculiar taste, stomatitis, abdominal cramps, blacktongue.
Endocrine: Gynecomastia in the male, breast enlargement and galactorrhea
in the female; increased or decreased libido, impotence; testicular swelling;
elevation or depression of blood sugar levels; syndrome of inappropriate ADH (antidiuretic
hormone) secretion.
Other: Jaundice (simulating obstructive), altered liver function; weight
gain or loss; perspiration; flushing; urinary frequency, nocturia; drowsiness,
dizziness, weakness, fatigue; headache; parotid swelling; alopecia.
Withdrawal Symptoms: Though these are not indicative of addiction, abrupt
cessation of treatment after prolonged therapy may produce nausea, headache, and
malaise.
Symptoms: Toxic overdosage may result in confusion, restlessness,
agitation, vomiting, hyperpyrexia, muscle rigidity, hyperactive reflexes,
tachycardia, ECG evidence of impaired conduction, shock, congestive heart
failure, stupor, coma, and CNS stimulation with convulsions (seizures) followed
by respiratory depression. Deaths have occurred following overdosage with drugs
of this class.
Treatment
If you or someone you know may have used more than the recommended dose of this
medicine, contact your local poison control center or emergency room
immediately.
Treatment should be symptomatic and supportive, but with special attention to
prevention or control of seizures. Renal failure may develop a few days after
substantial amoxapine overdosage in patients who may appear otherwise recovered.
Therefore, patients who may have ingested an overdosage of amoxapine,
particularly children, should be hospitalized and kept under close surveillance.
Empty stomach contents and administer activated charcoal.
After you start using this medicine, the initial clinical effect usually occurs
within 2 weeks of administration, but may be seen in some patients within 4 to 7
days. If your symptoms do not improve after taking this medicine for 4 weeks,
inform your doctor.
Do not exceed the recommended dosage or take this medicine for longer than
prescribed. Do not stop taking this medicine without checking with your doctor.
- Follow the directions for using this medicine provided by your doctor.
- Store this medicine at room temperature, away from heat and light.
- Continue to take this medicine even if you feel better. Do not miss any
doses.
- If you miss a dose of this medicine, take it as soon as possible. If it
is almost time for your next dose, skip the missed dose and go back to your
regular dosing schedule. Do not take 2 doses at once. If you take 1 dose
daily at bedtime, do not take missed dose the next morning.
Additional Information: Do not share this medicine with others for
whom it was not prescribed. Do not use this medicine for other health
conditions. Keep this medicine out of the reach of children.
IF USING THIS MEDICINE FOR AN EXTENDED PERIOD OF TIME, obtain refills before
your supply runs out.
Amoxapine is not recommended for children.
The dosage must be individualized according to the requirements of each
patient. Treatment should be initiated at the lowest recommended dose and
increased gradually with careful assessment of clinical response and any
evidence of intolerance. Once effective dosage is well established, the total
daily dosage may be given in a single daily dose (not to exceed 300 mg) at
bedtime. Total daily dosages higher than 300 mg should be given in divided
doses. Care should be taken not to increase the dosage of amoxapine if
manifestations of extrapyramidal effects occur, as there is a possibility of
development of tardive dyskinesia with this drug.
Usual Adult Dose: At first, 50 milligrams (mg) two to three times a
day. Your doctor may increase your dose gradually as needed. In severely
depressed hospitalized patients or patients under close supervision, a higher
initial dose of 50 mg 3 times daily may be indicated, and this may be increased
to 100 mg 2 or 3 times daily. The usual optimum dose is 150 to 300 mg daily, but
some patients may require higher doses, up to 400 mg or more daily, depending on
tolerance and response of each individual patient. Some hospitalized patients
have received doses up to 600 mg daily in divided doses. When higher doses are
used, it is essential to exclude history of convulsive disorders.
Elderly Patients: At first, 25 mg two to three times a day. Your
doctor may increase your dose gradually as needed.
How Supplied
Tablets: Scored tablets come in dosages of 25 mg, 50 mg, 100 mg.
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Reviewed: 01/2006
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