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Maprotiline Hydrochloride
Overview
What is Maprotiline Hydrochloride?
Maprotiline hydrochloride, USP is a tetracyclic antidepressant, available as 25 mg, 50 mg and 75 mg tablets for oral administration. Its chemical name is N-methyl-9,10-ethanoanthracene-9(10H)-propylamine hydrochloride, and its structural formula is:
Maprotiline hydrochloride is a fine, white to off-white, practically odorless crystalline powder. It is freely soluble in methanol and in chloroform, slightly soluble in water, and practically insoluble in isooctane. Its molecular weight is 313.87.
The tablets contain the following inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, hypromellose, magnesium stearate, microcrystalline cellulose, polydextrose, polyethylene glycol, pregelatinized starch (corn), sodium lauryl sulfate, titanium dioxide and triacetin. Additionally, the 50 mg tablet contains FD&C Blue No. 1 Aluminum Lake.
What does Maprotiline Hydrochloride look like?
What are the available doses of Maprotiline Hydrochloride?
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What should I talk to my health care provider before I take Maprotiline Hydrochloride?
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How should I use Maprotiline Hydrochloride?
Maprotiline hydrochloride tablets are indicated for the treatment of depressive illness in patients with depressive neurosis (dysthymic disorder) and manic depressive illness, depressed type (major depressive disorder). Maprotiline is also effective for the relief of anxiety associated with depression.
A single daily dose is an alternative to divided daily doses. Therapeutic effects are sometimes seen within 3 to 7 days, although as long as 2 to 3 weeks are usually necessary.
What interacts with Maprotiline Hydrochloride?
Maprotiline hydrochloride tablets are contraindicated in patients hypersensitive to maprotiline and in patients with known or suspected seizure disorders. It should not be given concomitantly with monoamine oxidase (MAO) inhibitors. A minimum of 14 days should be allowed to elapse after discontinuation of MAO inhibitors before treatment with maprotiline is initiated. Effects should be monitored with gradual increase in dosage until optimum response is achieved. The drug is not recommended for use during the acute phase of myocardial infarction.
What are the warnings of Maprotiline Hydrochloride?
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What are the precautions of Maprotiline Hydrochloride?
General
The possibility of suicide in seriously depressed patients is inherent in their illness and may persist until significant remission occurs. Therefore, patients must be carefully supervised during all phases of treatment with maprotiline, and prescriptions should be written for the smallest number of tablets consistent with good patient management.
Hypomanic or manic episodes have been known to occur in some patients taking tricyclic antidepressant drugs, particularly in patients with cyclic disorders. Such occurrences have also been noted, rarely, with maprotiline.
Prior to elective surgery, maprotiline should be discontinued for as long as clinically feasible, since little is known about the interaction between maprotiline and general anesthetics.
Maprotiline should be administered with caution in patients with history of urinary retention, or history of narrow angle glaucoma because of the drug's anticholinergic properties.
Information for Patients
Prescribers or other health professionals should inform patients, their families, and their caregivers about the benefits and risks associated with treatment with maprotiline and should counsel them in its appropriate use. A patient Medication Guide about "Antidepressant Medicines, Depression and other Serious Mental Illness and Suicidal Thoughts or Actions" is available for maprotiline. The prescriber or health professional should instruct patients, their families, and their caregivers to read the Medication Guide and should assist them in understanding its contents. Patients should be given the opportunity to discuss the contents of the Medication Guide and to obtain answers to any questions they may have. The complete text of the Medication Guide is reprinted at the end of this document.
Patients should be advised of the following issues and asked to alert their prescriber if these occur while taking maprotiline.
Patients should be advised that taking maprotiline can cause mild pupillary dilation, which in susceptible individuals, can lead to an episode of angle-closure glaucoma. Pre-existing glaucoma is almost always open-angle glaucoma because angle-closure glaucoma, when diagnosed, can be treated definitively with iridectomy. Open-angle glaucoma is not a risk factor for angle-closure glaucoma. Patients may wish to be examined to determine whether they are susceptible to angle-closure, and have a prophylactic procedure (e.g., iridectomy), if they are susceptible.
Patients, their families and their caregivers should be encouraged to be alert to the emergence of anxiety, agitation, panic attacks, insomnia, irritability, hostility, aggressiveness, impulsivity, akathisia (psychomotor restlessness), hypomania, mania, other unusual changes in behavior, worsening of depression, and suicidal ideation, especially early during antidepressant treatment and when the dose is adjusted up or down. Families and caregivers of patients should be advised to look for the emergence of such symptoms on a day to day basis, since changes may be abrupt. Such symptoms should be reported to the patient's prescriber or health professional, especially if they are severe, abrupt in onset, or were not part of the patient's presenting symptoms. Symptoms such as these may be associated with an increased risk for suicidal thinking and behavior and indicate a need for very close monitoring and possibly changes in the medication.
Laboratory Tests
Maprotiline should be discontinued if there is evidence of pathological neutrophil depression. Leukocyte and differential counts should be performed in patients who develop fever and sore throat during therapy.
Drug Interactions
Close supervision and careful adjustment of dosage are required when administering maprotiline concomitantly with anticholinergic or sympathomimetic drugs because of the possibility of additive atropine like effects.
Concurrent administration of maprotiline with electroshock therapy should be avoided because of the lack of experience in this area.
Caution should be exercised when administering maprotiline to hyperthyroid patients or those on thyroid medication because of the possibility of enhanced potential for cardiovascular toxicity of maprotiline.
Maprotiline should be used with caution in patients receiving guanethidine or similar agents since it may block the pharmacologic effects of these drugs.
The risk of seizures may be increased when maprotiline is taken concomitantly with phenothiazines or when the dosage of benzodiazepines is rapidly tapered in patients receiving maprotiline.
Because of the pharmacologic similarity of maprotiline hydrochloride to the tricyclic antidepressants, the plasma concentration of maprotiline may be increased when the drug is given concomitantly with hepatic enzyme inhibitors (e.g., cimetidine, fluoxetine) and decreased by concomitant administration with hepatic enzyme inducers (e.g., barbiturates, phenytoin), as has occurred with tricyclic antidepressants. Adjustment of the dosage of maprotiline hydrochloride may therefore be necessary in such cases.
(See .)
Carcinogenesis, Mutagenesis, Impairment of Fertility
Carcinogenicity and chronic toxicity studies have been conducted in laboratory rats and dogs. No drug- or dose-related occurrence of carcinogenesis was evident in rats receiving daily oral doses up to 60 mg/kg of maprotiline hydrochloride for 18 months or in dogs receiving daily oral doses up to 30 mg/kg of maprotiline hydrochloride for one year. In addition, no evidence of mutagenic activity was found in offspring of female mice mated with males treated with up to 60 times the maximum daily human dose.
Pregnancy
Reproduction studies have been performed in female laboratory rabbits, mice, and rats at doses up to 1.3, 7, and 9 times the maximum daily human dose respectively and have revealed no evidence of impaired fertility or harm to the fetus due to maprotiline. There are, however, no adequate and well controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed.
Labor and Delivery
Although the effect of maprotiline on labor and delivery is unknown, caution should be exercised as with any drug with CNS depressant action.
Nursing Mothers
Maprotiline is excreted in breast milk. At steady-state, the concentrations in milk correspond closely to the concentrations in whole blood. Caution should be exercised when maprotiline hydrochloride is administered to a nursing woman.
Pediatric Use
Safety and effectiveness in the pediatric population have not been established (see and ). Anyone considering the use of maprotiline in a child or adolescent must balance the potential risks with the clinical need.
What are the side effects of Maprotiline Hydrochloride?
The following adverse reactions have been noted with maprotiline and are generally similar to those observed with tricyclic antidepressants.
Cardiovascular:
Psychiatric:
Neurological:
Anticholinergic:
Allergic:
Gastrointestinal:
Endocrine:
Other:
Note:
— Bone marrow depression, including agranulocytosis, eosinophilia, purpura, and thrombocytopenia, myocardial infarction, stroke, peripheral neuropathy, sublingual adenitis, black tongue, stomatitis, paralytic ileus, gynecomastia in the male, breast enlargement and galactorrhea in the female, and testicular swelling.
Postintroduction Reports
Voluntary reports of adverse events temporally associated with maprotiline that have been received since market introduction and that may have no casual relationship with the drug include the following: interstitial pneumonitis which were in some cases associated with eosinophilia and increased liver enzymes, Stevens-Johnson Syndrome and Toxic Epidermal Necrolysis.
What should I look out for while using Maprotiline Hydrochloride?
Maprotiline hydrochloride tablets are contraindicated in patients hypersensitive to maprotiline and in patients with known or suspected seizure disorders. It should not be given concomitantly with monoamine oxidase (MAO) inhibitors. A minimum of 14 days should be allowed to elapse after discontinuation of MAO inhibitors before treatment with maprotiline is initiated. Effects should be monitored with gradual increase in dosage until optimum response is achieved. The drug is not recommended for use during the acute phase of myocardial infarction.
What might happen if I take too much Maprotiline Hydrochloride?
Deaths may occur from overdosage with this class of drugs. Multiple drug ingestion (including alcohol) is common in deliberate overdose. As the management is complex and changing, it is recommended that the physician contact a poison control center for current information on treatment. Signs and symptoms of toxicity develop rapidly after overdose. Therefore, hospital monitoring is required as soon as possible.
How should I store and handle Maprotiline Hydrochloride?
Store at 15° to 25°C (59° to 77°F). Do not freeze.Storage in automated dispensing machines: Brief exposure up to 2 weeks to ultraviolet or fluorescent light does not adversely affect the product labeling legibility; prolonged exposure can cause fading of the red label. Rotate stock frequently.Store at 15° to 25°C (59° to 77°F). Do not freeze.Storage in automated dispensing machines: Brief exposure up to 2 weeks to ultraviolet or fluorescent light does not adversely affect the product labeling legibility; prolonged exposure can cause fading of the red label. Rotate stock frequently.Maprotiline Hydrochloride, USP is available as tablets containing 25 mg, 50 mg, or 75 mg of maprotiline hydrochloride.The 25 mg tablets are white film-coated, round, scored tablets debossed with to the left of the score and to the right of the score on one side of the tablet and on the other side. They are available as follows:NDC 0378-0060-01bottles of 100 tabletsThe 50 mg tablets are light blue film-coated, round, scored, tablets debossed with to the left of the score and to the right of the score on one side and on the other side. They are available as follows:NDC 0378-0087-01bottles of 100 tabletsThe 75 mg tablets are white film-coated, round, scored tablets debossed with to the left of the score and to the right of the score on one side and on the other side. They are available as follows:NDC 0378-0092-01bottles of 100 tabletsStore at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.]Protect from light.Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure.PHARMACIST:Maprotiline Hydrochloride, USP is available as tablets containing 25 mg, 50 mg, or 75 mg of maprotiline hydrochloride.The 25 mg tablets are white film-coated, round, scored tablets debossed with to the left of the score and to the right of the score on one side of the tablet and on the other side. They are available as follows:NDC 0378-0060-01bottles of 100 tabletsThe 50 mg tablets are light blue film-coated, round, scored, tablets debossed with to the left of the score and to the right of the score on one side and on the other side. They are available as follows:NDC 0378-0087-01bottles of 100 tabletsThe 75 mg tablets are white film-coated, round, scored tablets debossed with to the left of the score and to the right of the score on one side and on the other side. They are available as follows:NDC 0378-0092-01bottles of 100 tabletsStore at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.]Protect from light.Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure.PHARMACIST:Maprotiline Hydrochloride, USP is available as tablets containing 25 mg, 50 mg, or 75 mg of maprotiline hydrochloride.The 25 mg tablets are white film-coated, round, scored tablets debossed with to the left of the score and to the right of the score on one side of the tablet and on the other side. They are available as follows:NDC 0378-0060-01bottles of 100 tabletsThe 50 mg tablets are light blue film-coated, round, scored, tablets debossed with to the left of the score and to the right of the score on one side and on the other side. They are available as follows:NDC 0378-0087-01bottles of 100 tabletsThe 75 mg tablets are white film-coated, round, scored tablets debossed with to the left of the score and to the right of the score on one side and on the other side. They are available as follows:NDC 0378-0092-01bottles of 100 tabletsStore at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.]Protect from light.Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure.PHARMACIST:Maprotiline Hydrochloride, USP is available as tablets containing 25 mg, 50 mg, or 75 mg of maprotiline hydrochloride.The 25 mg tablets are white film-coated, round, scored tablets debossed with to the left of the score and to the right of the score on one side of the tablet and on the other side. They are available as follows:NDC 0378-0060-01bottles of 100 tabletsThe 50 mg tablets are light blue film-coated, round, scored, tablets debossed with to the left of the score and to the right of the score on one side and on the other side. They are available as follows:NDC 0378-0087-01bottles of 100 tabletsThe 75 mg tablets are white film-coated, round, scored tablets debossed with to the left of the score and to the right of the score on one side and on the other side. They are available as follows:NDC 0378-0092-01bottles of 100 tabletsStore at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.]Protect from light.Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure.PHARMACIST:Maprotiline Hydrochloride, USP is available as tablets containing 25 mg, 50 mg, or 75 mg of maprotiline hydrochloride.The 25 mg tablets are white film-coated, round, scored tablets debossed with to the left of the score and to the right of the score on one side of the tablet and on the other side. They are available as follows:NDC 0378-0060-01bottles of 100 tabletsThe 50 mg tablets are light blue film-coated, round, scored, tablets debossed with to the left of the score and to the right of the score on one side and on the other side. They are available as follows:NDC 0378-0087-01bottles of 100 tabletsThe 75 mg tablets are white film-coated, round, scored tablets debossed with to the left of the score and to the right of the score on one side and on the other side. They are available as follows:NDC 0378-0092-01bottles of 100 tabletsStore at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.]Protect from light.Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure.PHARMACIST:Maprotiline Hydrochloride, USP is available as tablets containing 25 mg, 50 mg, or 75 mg of maprotiline hydrochloride.The 25 mg tablets are white film-coated, round, scored tablets debossed with to the left of the score and to the right of the score on one side of the tablet and on the other side. They are available as follows:NDC 0378-0060-01bottles of 100 tabletsThe 50 mg tablets are light blue film-coated, round, scored, tablets debossed with to the left of the score and to the right of the score on one side and on the other side. They are available as follows:NDC 0378-0087-01bottles of 100 tabletsThe 75 mg tablets are white film-coated, round, scored tablets debossed with to the left of the score and to the right of the score on one side and on the other side. They are available as follows:NDC 0378-0092-01bottles of 100 tabletsStore at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.]Protect from light.Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure.PHARMACIST:Maprotiline Hydrochloride, USP is available as tablets containing 25 mg, 50 mg, or 75 mg of maprotiline hydrochloride.The 25 mg tablets are white film-coated, round, scored tablets debossed with to the left of the score and to the right of the score on one side of the tablet and on the other side. They are available as follows:NDC 0378-0060-01bottles of 100 tabletsThe 50 mg tablets are light blue film-coated, round, scored, tablets debossed with to the left of the score and to the right of the score on one side and on the other side. They are available as follows:NDC 0378-0087-01bottles of 100 tabletsThe 75 mg tablets are white film-coated, round, scored tablets debossed with to the left of the score and to the right of the score on one side and on the other side. They are available as follows:NDC 0378-0092-01bottles of 100 tabletsStore at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.]Protect from light.Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure.PHARMACIST:Maprotiline Hydrochloride, USP is available as tablets containing 25 mg, 50 mg, or 75 mg of maprotiline hydrochloride.The 25 mg tablets are white film-coated, round, scored tablets debossed with to the left of the score and to the right of the score on one side of the tablet and on the other side. They are available as follows:NDC 0378-0060-01bottles of 100 tabletsThe 50 mg tablets are light blue film-coated, round, scored, tablets debossed with to the left of the score and to the right of the score on one side and on the other side. They are available as follows:NDC 0378-0087-01bottles of 100 tabletsThe 75 mg tablets are white film-coated, round, scored tablets debossed with to the left of the score and to the right of the score on one side and on the other side. They are available as follows:NDC 0378-0092-01bottles of 100 tabletsStore at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.]Protect from light.Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure.PHARMACIST:Maprotiline Hydrochloride, USP is available as tablets containing 25 mg, 50 mg, or 75 mg of maprotiline hydrochloride.The 25 mg tablets are white film-coated, round, scored tablets debossed with to the left of the score and to the right of the score on one side of the tablet and on the other side. They are available as follows:NDC 0378-0060-01bottles of 100 tabletsThe 50 mg tablets are light blue film-coated, round, scored, tablets debossed with to the left of the score and to the right of the score on one side and on the other side. They are available as follows:NDC 0378-0087-01bottles of 100 tabletsThe 75 mg tablets are white film-coated, round, scored tablets debossed with to the left of the score and to the right of the score on one side and on the other side. They are available as follows:NDC 0378-0092-01bottles of 100 tabletsStore at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.]Protect from light.Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure.PHARMACIST:Maprotiline Hydrochloride, USP is available as tablets containing 25 mg, 50 mg, or 75 mg of maprotiline hydrochloride.The 25 mg tablets are white film-coated, round, scored tablets debossed with to the left of the score and to the right of the score on one side of the tablet and on the other side. They are available as follows:NDC 0378-0060-01bottles of 100 tabletsThe 50 mg tablets are light blue film-coated, round, scored, tablets debossed with to the left of the score and to the right of the score on one side and on the other side. They are available as follows:NDC 0378-0087-01bottles of 100 tabletsThe 75 mg tablets are white film-coated, round, scored tablets debossed with to the left of the score and to the right of the score on one side and on the other side. They are available as follows:NDC 0378-0092-01bottles of 100 tabletsStore at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.]Protect from light.Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure.PHARMACIST:Maprotiline Hydrochloride, USP is available as tablets containing 25 mg, 50 mg, or 75 mg of maprotiline hydrochloride.The 25 mg tablets are white film-coated, round, scored tablets debossed with to the left of the score and to the right of the score on one side of the tablet and on the other side. They are available as follows:NDC 0378-0060-01bottles of 100 tabletsThe 50 mg tablets are light blue film-coated, round, scored, tablets debossed with to the left of the score and to the right of the score on one side and on the other side. They are available as follows:NDC 0378-0087-01bottles of 100 tabletsThe 75 mg tablets are white film-coated, round, scored tablets debossed with to the left of the score and to the right of the score on one side and on the other side. They are available as follows:NDC 0378-0092-01bottles of 100 tabletsStore at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.]Protect from light.Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure.PHARMACIST:
Clinical Information
Chemical Structure
No Image foundClinical Pharmacology
The mechanism of action of maprotiline is not precisely known. It does not act primarily by stimulation of the central nervous system and is not a monoamine oxidase inhibitor. The postulated mechanism of maprotiline is that it acts primarily by potentiation of central adrenergic synapses by blocking reuptake of norepinephrine at nerve endings. This pharmacologic action is thought to be responsible for the drug's antidepressant and anxiolytic effects.
The mean time to peak is 12 hours. The half-life of elimination averages 51 hours.
Steady-state levels measured prior to the morning dose on a one dosage regimen are summarized as follows:
Non-Clinical Toxicology
Maprotiline hydrochloride tablets are contraindicated in patients hypersensitive to maprotiline and in patients with known or suspected seizure disorders. It should not be given concomitantly with monoamine oxidase (MAO) inhibitors. A minimum of 14 days should be allowed to elapse after discontinuation of MAO inhibitors before treatment with maprotiline is initiated. Effects should be monitored with gradual increase in dosage until optimum response is achieved. The drug is not recommended for use during the acute phase of myocardial infarction.Close supervision and careful adjustment of dosage are required when administering maprotiline concomitantly with anticholinergic or sympathomimetic drugs because of the possibility of additive atropine like effects.
Concurrent administration of maprotiline with electroshock therapy should be avoided because of the lack of experience in this area.
Caution should be exercised when administering maprotiline to hyperthyroid patients or those on thyroid medication because of the possibility of enhanced potential for cardiovascular toxicity of maprotiline.
Maprotiline should be used with caution in patients receiving guanethidine or similar agents since it may block the pharmacologic effects of these drugs.
The risk of seizures may be increased when maprotiline is taken concomitantly with phenothiazines or when the dosage of benzodiazepines is rapidly tapered in patients receiving maprotiline.
Because of the pharmacologic similarity of maprotiline hydrochloride to the tricyclic antidepressants, the plasma concentration of maprotiline may be increased when the drug is given concomitantly with hepatic enzyme inhibitors (e.g., cimetidine, fluoxetine) and decreased by concomitant administration with hepatic enzyme inducers (e.g., barbiturates, phenytoin), as has occurred with tricyclic antidepressants. Adjustment of the dosage of maprotiline hydrochloride may therefore be necessary in such cases.
(See .)
The possibility of suicide in seriously depressed patients is inherent in their illness and may persist until significant remission occurs. Therefore, patients must be carefully supervised during all phases of treatment with maprotiline, and prescriptions should be written for the smallest number of tablets consistent with good patient management.
Hypomanic or manic episodes have been known to occur in some patients taking tricyclic antidepressant drugs, particularly in patients with cyclic disorders. Such occurrences have also been noted, rarely, with maprotiline.
Prior to elective surgery, maprotiline should be discontinued for as long as clinically feasible, since little is known about the interaction between maprotiline and general anesthetics.
Maprotiline should be administered with caution in patients with history of urinary retention, or history of narrow angle glaucoma because of the drug's anticholinergic properties.
The following adverse reactions have been noted with maprotiline and are generally similar to those observed with tricyclic antidepressants.
Cardiovascular:
Psychiatric:
Neurological:
Anticholinergic:
Allergic:
Gastrointestinal:
Endocrine:
Other:
Note:
— Bone marrow depression, including agranulocytosis, eosinophilia, purpura, and thrombocytopenia, myocardial infarction, stroke, peripheral neuropathy, sublingual adenitis, black tongue, stomatitis, paralytic ileus, gynecomastia in the male, breast enlargement and galactorrhea in the female, and testicular swelling.
Reference
This information is obtained from the National Institute of Health's Standard Packaging Label drug database.
"https://dailymed.nlm.nih.gov/dailymed/"
While we update our database periodically, we cannot guarantee it is always updated to the latest version.
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