AMITRIPTYLINE HYDROCHLORIDE tablet, film coated

Amitriptyline Hydrochloride by

Drug Labeling and Warnings

Amitriptyline Hydrochloride by is a Prescription medication manufactured, distributed, or labeled by Sun Pharmaceutical Industries, Inc., Frontida BioPharm Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Nursing Mothers

Amitriptyline is excreted into breast milk. In one report in which a patient received amitriptyline 100 mg/day while nursing her infant, levels of 83 to 141 ng/mL were detected in the mother's serum. Levels of 135 to 151 ng/mL were found in the breast milk, but no trace of the drug could be detected in the infant's serum.

Because of the potential for serious adverse reactions in nursing infants from amitriptyline, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.

Usage in Pediatric Patients

In view of the lack of experience with the use of this drug in pediatric patients, it is not recommended at the present time for patients under 12 years of age.

  • PRECAUTIONS

    Schizophrenic patients may develop increased symptoms of psychosis; patients with paranoid symptomatology may have an exaggeration of such symptoms. Depressed patients, particularly those with known manic-depressive illness, may experience a shift to mania or hypomania. In these circumstances the dose of amitriptyline may be reduced or a major tranquilizer such as perphenazine may be administered concurrently.

    The possibility of suicide in depressed patients remains until significant remission occurs. Potentially suicidal patients should not have access to large quantities of this drug. Prescriptions should be written for the smallest amount feasible.

    Concurrent administration of amitriptyline hydrochloride and electroshock therapy may increase the hazards associated with such therapy. Such treatment should be limited to patients for whom it is essential.

    When possible, the drug should be discontinued several days before elective surgery.

    Both elevation and lowering of blood sugar levels have been reported.

    Amitriptyline hydrochloride should be used with caution in patients with impaired liver function.

    This product contains FD&C Yellow No. 5 (tartrazine) which may cause allergic-type reactions

    (including bronchial asthma) in certain susceptible persons. Although the overall incidence of FD&C

    Yellow No. 5 (tartrazine) sensitivity in the general population is low, it is frequently seen in patients

    who also have aspirin hypersensitivity.

    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 amitriptyline hydrochloride and should counsel them in its appropriate use. A patient Medication Guide about "Antidepressant Medicines, Depression and other Serious Mental Illnesses, and Suicidal Thoughts or Actions" is available for amitriptyline hydrochloride. 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 amitriptyline hydrochloride.

    Patients should be advised that taking amitriptyline hydrochloride 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.

    Clinical Worsening and Suicide Risk

    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.

    While on therapy with amitriptyline hydrochloride, patients should be advised as to the possible impairment of mental and/or physical abilities required for performance of hazardous tasks, such as operating machinery or driving a motor vehicle.

    Drug Interactions

    Topiramate

    Some patients may experience a large increase in amitriptyline concentration in the presence of topiramate and any adjustments in amitriptyline dose should be made according to the patient's clinical response and not on the basis of plasma levels.

    Drugs Metabolized by P450 2D6

    The biochemical activity of the drug metabolizing isozyme cytochrome P450 2D6 (debrisoquin hydroxylase) is reduced in a subset of the caucasian population (about 7 to 10% of Caucasians are so called "poor metabolizers"), reliable estimates of the prevalence of reduced P450 2D6 isozyme activity among Asian, African and other populations are not yet available. Poor metabolizers have higher than expected plasma concentrations of tricyclic antidepressants (TCAs) when given usual doses. Depending on the fraction of drug metabolized by P450 2D6, the increase in plasma concentration may be small, or quite large (8 fold increase in plasma AUC of the TCA).

    In addition, certain drugs inhibit the activity of this isozyme and make normal metabolizers resemble poor metabolizers. An individual who is stable on a given dose of TCA may become abruptly toxic when given one of these inhibiting drugs as concomitant therapy. The drugs that inhibit cytochrome P450 2D6 include some that are not metabolized by the enzyme (quinidine; cimetidine) and many that are substrates for P450 2D6 (many other antidepressants, phenothiazines, and the Type 1C antiarrhythmics propafenone and flecainide). While all the selective serotonin reuptake inhibitors (SSRIs), e.g., fluoxetine, sertraline, and paroxetine, inhibit P450 2D6, they may vary in the extent of inhibition. The extent to which SSRI-TCA interactions may pose clinical problems will depend on the degree of inhibition and the pharmacokinetics of the SSRI involved. Nevertheless, caution is indicated in the coadministration of TCAs with any of the SSRIs and also in switching from one class to the other. Of particular importance, sufficient time must elapse before initiating TCA treatment in a patient being withdrawn from fluoxetine, given the long half-life of the parent and active metabolite (at least 5 weeks may be necessary).

    Concomitant use of tricyclic antidepressants with drugs that can inhibit cytochrome P450 2D6 may require lower doses than usually prescribed for either the tricyclic antidepressant or the other drug. Furthermore, whenever one of these other drugs is withdrawn from co-therapy, an increased dose of tricyclic antidepressant may be required. It is desirable to monitor TCA plasma levels whenever a TCA is going to be coadministered with another drug known to be an inhibitor of P450 2D6.

    Monoamine oxidase inhibitors – see CONTRAINDICATIONS section. Guanethidine or similarly acting compounds; thyroid medication; alcohol, barbiturates and other CNS depressants; and disulfiram – see WARNINGS section.

    When amitriptyline is given with anticholinergic agents or sympathomimetic drugs, including epinephrine combined with local anesthetics, close supervision and careful adjustment of dosages are required.

    Hyperpyrexia has been reported when amitriptyline is administered with anticholinergic agents or with neuroleptic drugs, particularly during hot weather.

    Paralytic ileus may occur in patients taking tricyclic antidepressants in combination with anticholinergic-type drugs.

    Cimetidine is reported to reduce hepatic metabolism of certain tricyclic antidepressants, thereby delaying elimination and increasing steady-state concentrations of these drugs. Clinically significant effects have been reported with the tricyclic antidepressants when used concomitantly with cimetidine. Increases in plasma levels of tricyclic antidepressants, and in the frequency and severity of side effects, particularly anticholinergic, have been reported when cimetidine was added to the drug regimen. Discontinuation of cimetidine in well-controlled patients receiving tricyclic antidepressants and cimetidine may decrease the plasma levels and efficacy of the antidepressants.

    Caution is advised if patients receive large doses of ethchlorvynol concurrently. Transient delirium has been reported in patients who were treated with one gram of ethchlorvynol and 75 to 150 mg of amitriptyline hydrochloride.

    Geriatric Use

    Clinical experience has not identified differences in responses between elderly and younger patients. In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic function, concomitant disease and other drug therapy in elderly patients.

    Geriatric patients are particularly sensitive to the anticholinergic side effects of tricyclic antidepressants including amitriptyline hydrochloride. Peripheral anticholinergic effects include tachycardia, urinary retention, constipation, dry mouth, blurred vision, and exacerbation of narrow-angle glaucoma. Central nervous system anticholinergic effects include cognitive impairment, psychomotor slowing, confusion, sedation, and delirium. Elderly patients taking amitriptyline hydrochloride may be at increased risk for falls. Elderly patients should be started on low doses of amitriptyline hydrochloride and observed closely (see DOSAGE AND ADMINISTRATION).

    Pediatric Use

    Safety and effectiveness in the pediatric population have not been established (see BOX WARNING and WARNINGS: Clinical Worsening and Suicide Risk). Anyone considering the use of amitriptyline in a child or adolescent must balance the potential risks with the clinical need.

  • ADVERSE REACTIONS

    Within each category the following adverse reactions are listed in order of decreasing severity. Included in the listing are a few adverse reactions which have not been reported with this specific drug. However, pharmacological similarities among the tricyclic antidepressant drugs require that each of the reactions be considered when amitriptyline is administered.

    Cardiovascular: Myocardial infarction; stroke; nonspecific ECG changes and changes in AV conduction; heart block; arrhythmias; hypotension, particularly orthostatic hypotension; syncope; hypertension; tachycardia; palpitation.

    CNS and Neuromuscular: Coma; seizures; hallucinations; delusions; confusional states; disorientation; incoordination; ataxia; tremors; peripheral neuropathy; numbness, tingling, and paresthesias of the extremities; extrapyramidal symptoms including abnormal involuntary movements and tardive dyskinesia; dysarthria; disturbed concentration; excitement; anxiety; insomnia; restlessness; nightmares; drowsiness; dizziness; weakness; fatigue; headache; syndrome of inappropriate ADH (antidiuretic hormone) secretion; tinnitus; alteration in EEG patterns.

    Anticholinergic: Paralytic ileus; hyperpyrexia; urinary retention; dilatation of the urinary tract; constipation; blurred vision, disturbance of accommodation, increased ocular pressure, mydriasis; dry mouth.

    Allergic: Skin rash; urticaria; photosensitization; edema of face and tongue.

    Hematologic: Bone marrow depression including agranulocytosis, leukopenia, thrombocytopenia; purpura; eosinophilia.

    Gastrointestinal: Rarely hepatitis (including altered liver function and jaundice); nausea; epigastric distress; vomiting; anorexia; stomatitis; peculiar taste; diarrhea; parotid swelling; black tongue.

    Endocrine: Testicular swelling and gynecomastia in the male; breast enlargement and galactorrhea in the female; increased or decreased libido; impotence; elevation and lowering of blood sugar levels.

    Other: Alopecia; edema; weight gain or loss; urinary frequency; increased perspiration.

    Withdrawal Symptoms

    After prolonged administration, abrupt cessation of treatment may produce nausea, headache, and malaise. Gradual dosage reduction has been reported to produce, within two weeks, transient symptoms including irritability, restlessness, and dream and sleep disturbance.

    These symptoms are not indicative of addiction. Rare instances have been reported of mania or hypomania occurring within 2 to 7 days following cessation of chronic therapy with tricyclic antidepressants.

    Causal Relationship Unknown

    Other reactions, reported under circumstances where a causal relationship could not be established, are listed to serve as alerting information to physicians:

    Body as a Whole: Lupus-like syndrome (migratory arthritis, positive ANA and rheumatoid factor).

    Digestive: Hepatic failure, ageusia.

    Postmarketing Adverse Events

    A syndrome resembling neuroleptic malignant syndrome (NMS) has been very rarely reported after starting or increasing the dose of amitriptyline hydrochloride, with and without concomitant medications known to cause NMS. Symptoms have included muscle rigidity, fever, mental status changes, diaphoresis, tachycardia, and tremor.

    Very rare cases of serotonin syndrome (SS) have been reported with amitriptyline hydrochloride in combination with other drugs that have a recognized association with SS.

  • OVERDOSAGE

    Deaths may occur from overdosage with this class of drugs. Multiple drug ingestion (including alcohol) is common in deliberate tricyclic antidepressant 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 tricyclic antidepressant overdose, therefore, hospital monitoring is required as soon as possible.

    Manifestations

    Critical manifestations of overdose include: cardiac dysrhythmias, severe hypotension, convulsions, and CNS depression, including coma. Changes in the electrocardiogram, particularly in, QRS axis or width, are clinically significant indicators of tricyclic antidepressant toxicity. In addition, a rightward axis shift in the terminal QRS complex together with a prolonged QT interval and sinus tachycardia are specific and sensitive indicators of first generation tricyclic overdose. The absence of these findings is not exclusionary. Prolonged PR interval, ST-T wave changes, ventricular tachycardia and fibrillation may also occur.

    Other signs of overdose may include: impaired myocardial contractility, confusion, disturbed concentration, transient visual hallucinations, dilated pupils, disorders of ocular motility, agitation, hyperactive reflexes, polyradiculoneuropathy, stupor, drowsiness, muscle rigidity, vomiting, hypothermia, hyperpyrexia, or any of the symptoms listed under ADVERSE REACTIONS.

    Management

    General

    Obtain an ECG and immediately initiate cardiac monitoring. Protect the patient's airway, establish an intravenous line and initiate gastric decontamination. A minimum of six hours of observation with cardiac monitoring and observation for signs of CNS or respiratory depression, hypotension, cardiac dysrhythmias and/or conduction blocks, and seizures is necessary. If signs of toxicity occur at any time during the period, extended monitoring is required. There are case reports of patients succumbing to fatal dysrhythmias late after overdose; these patients had clinical evidence of significant poisoning prior to death and most received inadequate gastrointestinal decontamination. Monitoring of plasma drug levels should not guide management of the patient.

    Gastrointestinal Decontamination

    All patients suspected of tricyclic antidepressant overdose should receive gastrointestinal decontamination. This should include, large volume gastric lavage followed by activated charcoal. If consciousness is impaired, the airway should be secured prior to lavage. EMESIS IS CONTRAINDICATED.

    Cardiovascular

    A maximal limb-lead QRS duration of ≥0.10 seconds may be the best indication of the severity of the overdose. Intravenous sodium bicarbonate should be used to maintain the serum pH in the range of 7.45 to 7.55. If the pH response is inadequate, hyperventilation may also be used. Concomitant use of hyperventilation and sodium bicarbonate should be done with extreme caution, with frequent pH monitoring. A pH >7.60 or a pCO2 <20 mm Hg is undesirable. Dysrhythmias unresponsive to sodium bicarbonate therapy/hyperventilation may respond to lidocaine, bretylium or phenytoin. Type 1 A and 1 C antiarrhythmics are generally contraindicated (e.g., quinidine, disopyramide, and procainamide).

    In rare instances, hemoperfusion may be beneficial in acute refractory cardiovascular instability in patients with acute toxicity. However, hemodialysis, peritoneal dialysis, exchange transfusions, and forced diuresis generally have been reported as ineffective in tricyclic antidepressant poisoning.

    CNS

    In patients with CNS depression, early intubation is advised because of the potential for abrupt deterioration. Seizures should be controlled with benzodiazepines, or if these are ineffective, other anticonvulsants (e.g., phenobarbital, phenytoin).

    Physostigmine is not recommended except to treat life-threatening symptoms that have been unresponsive to other therapies, and then only in consultation with a poison control center.

    Psychiatric Follow-up

    Since overdosage is often deliberate, patients may attempt suicide by other means during the recovery phase. Psychiatric referral may be appropriate.

    Pediatric Management

    The principles of management of pediatric and adult overdosages are similar. It is strongly recommended that the physician contact the local poison control center for specific pediatric treatment.

  • DOSAGE AND ADMINISTRATION

    Oral Dosage

    Dosage should be initiated at a low level and increased gradually, noting carefully the clinical response and any evidence of intolerance.

    Initial Dosage for Adults

    For outpatients 75 mg of amitriptyline HCl a day in divided doses is usually satisfactory. If necessary, this may be increased to a total of 150 mg per day. Increases are made preferably in the late afternoon and/or bedtime doses. A sedative effect may be apparent before the antidepressant effect is noted, but an adequate therapeutic effect may take as long as 30 days to develop.

    An alternate method of initiating therapy in outpatients is to begin with 50 to 100 mg amitriptyline HCl at bedtime. This may be increased by 25 or 50 mg as necessary in the bedtime dose to a total of 150 mg per day.

    Hospitalized patients may require 100 mg a day initially. This can be increased gradually to 200 mg a day if necessary. A small number of hospitalized patients may need as much as 300 mg a day.

    Adolescent and Elderly Patients

    In general, lower dosages are recommended for these patients. Ten mg 3 times a day with 20 mg at bedtime may be satisfactory in adolescent and elderly patients who do not tolerate higher dosages.

    Maintenance

    The usual maintenance dosage of amitriptyline HCl is 50 to 100 mg per day. In some patients 40 mg per day is sufficient. For maintenance therapy the total daily dosage may be given in a single dose preferably at bedtime. When satisfactory improvement has been reached, dosage should be reduced to the lowest amount that will maintain relief of symptoms. It is appropriate to continue maintenance therapy 3 months or longer, to lessen the possibility of relapse.

    Usage in Pediatric Patients

    In view of the lack of experience with the use of this drug in pediatric patients, it is not recommended at the present time for patients under 12 years of age.

    Plasma Levels

    Because of the wide variation in the absorption and distribution of tricyclic antidepressants in body fluids, it is difficult to directly correlate plasma levels and therapeutic effect. However, determination of plasma levels may be useful in identifying patients who appear to have toxic effects and may have excessively high levels, or those in whom lack of absorption or noncompliance is suspected. Because of increased intestinal transit time and decreased hepatic metabolism in elderly patients, plasma levels are generally higher for a given oral dose of amitriptyline hydrochloride than in younger patients. Elderly patients should be monitored carefully and quantitative serum levels obtained as clinically appropriate. Adjustments in dosage should be made according to the patient's clinical response and not on the basis of plasma levels.2


  • 2 Hollister, L.E.; Monitoring Tricyclic Antidepressant Plasma Concentrations. JAMA 1979; 241 (23):2530-2533.
  • HOW SUPPLIED

    Amitriptyline hydrochloride tablets USP, are available as follows:

    Amitriptyline hydrochloride tablets, 10 mg, pink, round, film coated, debossed MP 10

    •   Bottles of 100 CRC

    NDC: 57664-687-88

    Bottles of 1000

    NDC: 57664-687-18

    Amitriptyline hydrochloride tablets, 25 mg, green, round, film coated, debossed MP 25

    •   Bottles of 100 CRC

    NDC: 57664-688-88

    Bottles of 1000

    NDC: 57664-688-18

    Amitriptyline hydrochloride tablets, 50 mg, brown, round, film coated, debossed MP 26

    •   Bottles of 100 CRC

    NDC: 57664-689-88

    Bottles of 1000

    NDC: 57664-689-18

    Amitriptyline hydrochloride tablets, 75 mg, purple, round, film coated, debossed MP 27

    •   Bottles of 100 CRC

    NDC: 57664-692-88

    Amitriptyline hydrochloride tablets, 100 mg, orange, round, film coated, debossed MP 28

    •   Bottles of 100 CRC

    NDC: 57664-690-88

    Amitriptyline hydrochloride tablets, 150 mg, peach, capsule shaped, film coated, debossed MP 29

    •   Bottles of 100 CRC

    NDC: 57664-691-88

    Store at 20° to 25°C (68° to 77°F).
    [See USP Controlled Room Temperature]

    DISPENSE IN TIGHT, LIGHT-RESISTANT CONTAINER.

  • METABOLISM

    Studies in man following oral administration of 14C-labeled drug indicated that amitriptyline is rapidly absorbed and metabolized. Radioactivity of the plasma was practically negligible, although significant amounts of radioactivity appeared in the urine by 4 to 6 hours and one-half to one-third of the drug was excreted within 24 hours.

    Amitriptyline is metabolized by N-demethylation and bridge hydroxylation in man, rabbit and rat. Virtually the entire dose is excreted as glucuronide or sulfate conjugate of metabolites, with little unchanged drug appearing in the urine. Other metabolic pathways may be involved.

  • REFERENCES

    Ayd, F.J., Jr.: Amitriptyline therapy for depressive reactions, Psychosom. 1: 320–325, Nov.–Dec. 1960.

    Diamond, S.: Human metabolization of amitriptyline tagged with carbon 14, Curr. Therap. Res.7: 170–175, Mar. 1965.

    Dorfman, W.: Clinical experiences with amitriptyline (A preliminary report), Psychosom. 1: 153–155, May–June 1960.

    Fallette, J.M.; Stasney, C.R.; Mintz, A.A.: Amitriptyline poisoning treated with physostigmine, S. Med. J. 63: 1492–1493, Dec. 1970 (in Soc. Proc.).

    Hollister, L.E.; Overall, J.E.; Johnson, M.; Pennington, V.; Katz, G.; Shelton, J.: Controlled comparison of amitriptyline, imipramine and placebo in hospitalized depressed patients, J. Nerv. and Ment. Dis. 139: 370–375, Oct. 1964.

    Hordern, A.; Burt, C.G.; Holt, N.F.: Depressive states. A pharmacotherapeutic study, Springfield, Ill., Charles C. Thomas, 1965.

    Jenike, M.A.: Treatment of Affective Illness in the Elderly with Drugs and Electroconvulsive Therapy, J. Geriatr. Psychiatry 1989;22(1).77–112.

    Klerman, G.L.; Cole, J.O.: Clinical pharmacology of imipramine and related antidepressant compounds, Int. J. Psychiat. 3: 267–304, Apr. 1976.

    Liu, B.; Anderson, C.; Mittman, N. et al: Use of selective serotonin-reuptake inhibitors or tricyclic antidepressants and risk of hip fractures in elderly people. Lancet 1998; 351 (9112):1303–1307.

    McConaghy, N.; Joffe, A.D.; Kingston, W.R.; Stevenson, H.G.; Atkinson, I.; Cole, E.; Fennessy, L.A.; Correlation of clinical features of depressed outpatients with response to amitriptyline and protriptyline, Brit. J. Psychiat. 114: 103–106, Jan. 1968.

    McDonald, I.M.; Perkins, M.; Marjerrison, G.; Podilsky, M.: A controlled comparison of amitriptyline and electroconvulsive therapy in the treatment of depression, Amer. J. Psychiat. 122: 1427–1431. June 1966 (in Brief Communications).

    Slovis, T.; Ott, J.; Teitelbaum, D.; Lipscomb, W.: Physostigmine therapy in acute tricyclic antidepressant poisoning. Clin. Toxicol. 4: 451–459, Sept. 1971.

    Symposium on depression with special studies of a new antidepressant, amitriptyline, Dis. Nerv. Syst. 22: 5–56, May 1961 (Sect. 2).

  • SPL UNCLASSIFIED SECTION

    Distributed by:
    Sun Pharmaceutical Industries, Inc.
    Cranbury, NJ 08512

  • MEDICATION GUIDEAmitriptyline Hydrochloride Tablets, USP

    (am'' i trip' ti leen hye'' droe klor' ide)

    Antidepressant Medicines, Depression and other Serious Mental Illnesses, and Suicidal Thoughts or Actions

    Read the Medication Guide that comes with you or your family member's antidepressant medicine. This Medication Guide is only about the risk of suicidal thoughts and actions with antidepressant medicines.

    Talk to your, or your family member's, healthcare provider about:

    What is the most important information I should know about antidepressant medicines, depression and other serious mental illnesses, and suicidal thoughts or actions?

    What else do I need to know about antidepressant medicines?

    Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

    This Medication Guide has been approved by the U.S. Food and Drug Administration for all antidepressants.

    Distributed by:
    Sun Pharmaceutical Industries, Inc.
    Cranbury, NJ 08512

  • PACKAGE/LABEL PRINCIPAL DISPLAY PANEL

    Frontida-10mg
    Alkaloida-10mg
  • PRINCIPAL DISPLAY PANEL – 25mg

    Frontida-25mg
    Alkaloida-25mg
  • PRINCIPAL DISPLAY PANEL – 50mg

    Frontida-50mg
    Alkaloida-50mg
  • PRINCIPAL DISPLAY PANEL – 75mg

    Frontida-75mg
    Alkaloida-75mg
  • PRINCIPAL DISPLAY PANEL – 100mg

    Frontida-100mg
    Alkaloida-100mg
  • PRINCIPAL DISPLAY PANEL – 150mg

    Frontida-150mg
    Alkaloida-150mg
  • INGREDIENTS AND APPEARANCE
    AMITRIPTYLINE HYDROCHLORIDE 
    amitriptyline hydrochloride tablet, film coated
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC: 57664-687
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Amitriptyline Hydrochloride (UNII: 26LUD4JO9K) (Amitriptyline - UNII:1806D8D52K) Amitriptyline Hydrochloride10 mg
    Inactive Ingredients
    Ingredient NameStrength
    silicon dioxide (UNII: ETJ7Z6XBU4)  
    croscarmellose sodium (UNII: M28OL1HH48)  
    lactose monohydrate (UNII: EWQ57Q8I5X)  
    magnesium stearate (UNII: 70097M6I30)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    titanium dioxide (UNII: 15FIX9V2JP)  
    D&C Red No. 27 (UNII: 2LRS185U6K)  
    Aluminum Oxide (UNII: LMI26O6933)  
    FD&C Blue No. 1 (UNII: H3R47K3TBD)  
    POLYVINYL ALCOHOL, UNSPECIFIED (UNII: 532B59J990)  
    FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
    TALC (UNII: 7SEV7J4R1U)  
    Product Characteristics
    ColorPINKScoreno score
    ShapeROUNDSize6mm
    FlavorImprint Code MP;10
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC: 57664-687-88100 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product07/14/1987
    2NDC: 57664-687-181000 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product07/14/1987
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA08939907/14/1987
    AMITRIPTYLINE HYDROCHLORIDE 
    amitriptyline hydrochloride tablet, film coated
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC: 57664-688
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Amitriptyline Hydrochloride (UNII: 26LUD4JO9K) (Amitriptyline - UNII:1806D8D52K) Amitriptyline Hydrochloride25 mg
    Inactive Ingredients
    Ingredient NameStrength
    silicon dioxide (UNII: ETJ7Z6XBU4)  
    croscarmellose sodium (UNII: M28OL1HH48)  
    lactose monohydrate (UNII: EWQ57Q8I5X)  
    magnesium stearate (UNII: 70097M6I30)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    titanium dioxide (UNII: 15FIX9V2JP)  
    D&C Yellow No. 10 (UNII: 35SW5USQ3G)  
    Aluminum Oxide (UNII: LMI26O6933)  
    FD&C Blue No. 1 (UNII: H3R47K3TBD)  
    FD&C Red No. 40 (UNII: WZB9127XOA)  
    POLYVINYL ALCOHOL, UNSPECIFIED (UNII: 532B59J990)  
    TALC (UNII: 7SEV7J4R1U)  
    Product Characteristics
    ColorGREENScoreno score
    ShapeROUNDSize6mm
    FlavorImprint Code MP;25
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC: 57664-688-88100 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product07/14/1987
    2NDC: 57664-688-181000 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product07/14/1987
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA08939907/14/1987
    AMITRIPTYLINE HYDROCHLORIDE 
    amitriptyline hydrochloride tablet, film coated
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC: 57664-689
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Amitriptyline Hydrochloride (UNII: 26LUD4JO9K) (Amitriptyline - UNII:1806D8D52K) Amitriptyline Hydrochloride50 mg
    Inactive Ingredients
    Ingredient NameStrength
    silicon dioxide (UNII: ETJ7Z6XBU4)  
    croscarmellose sodium (UNII: M28OL1HH48)  
    lactose monohydrate (UNII: EWQ57Q8I5X)  
    magnesium stearate (UNII: 70097M6I30)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    titanium dioxide (UNII: 15FIX9V2JP)  
    FD&C Red No. 40 (UNII: WZB9127XOA)  
    Aluminum Oxide (UNII: LMI26O6933)  
    FD&C Blue No. 2 (UNII: L06K8R7DQK)  
    POLYVINYL ALCOHOL, UNSPECIFIED (UNII: 532B59J990)  
    TALC (UNII: 7SEV7J4R1U)  
    FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
    Product Characteristics
    ColorBROWNScoreno score
    ShapeROUNDSize8mm
    FlavorImprint Code MP;26
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC: 57664-689-88100 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product07/14/1987
    2NDC: 57664-689-181000 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product07/14/1987
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA08939907/14/1987
    AMITRIPTYLINE HYDROCHLORIDE 
    amitriptyline hydrochloride tablet, film coated
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC: 57664-692
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Amitriptyline Hydrochloride (UNII: 26LUD4JO9K) (Amitriptyline - UNII:1806D8D52K) Amitriptyline Hydrochloride75 mg
    Inactive Ingredients
    Ingredient NameStrength
    silicon dioxide (UNII: ETJ7Z6XBU4)  
    croscarmellose sodium (UNII: M28OL1HH48)  
    lactose monohydrate (UNII: EWQ57Q8I5X)  
    magnesium stearate (UNII: 70097M6I30)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    titanium dioxide (UNII: 15FIX9V2JP)  
    D&C Red No. 7 (UNII: ECW0LZ41X8)  
    Aluminum Oxide (UNII: LMI26O6933)  
    POLYVINYL ALCOHOL, UNSPECIFIED (UNII: 532B59J990)  
    TALC (UNII: 7SEV7J4R1U)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    Product Characteristics
    ColorPURPLEScoreno score
    ShapeROUNDSize10mm
    FlavorImprint Code MP;27
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC: 57664-692-88100 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product07/14/1987
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA08939907/14/1987
    AMITRIPTYLINE HYDROCHLORIDE 
    amitriptyline hydrochloride tablet, film coated
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC: 57664-690
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Amitriptyline Hydrochloride (UNII: 26LUD4JO9K) (Amitriptyline - UNII:1806D8D52K) Amitriptyline Hydrochloride100 mg
    Inactive Ingredients
    Ingredient NameStrength
    silicon dioxide (UNII: ETJ7Z6XBU4)  
    croscarmellose sodium (UNII: M28OL1HH48)  
    lactose monohydrate (UNII: EWQ57Q8I5X)  
    magnesium stearate (UNII: 70097M6I30)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    titanium dioxide (UNII: 15FIX9V2JP)  
    D&C Yellow No. 10 (UNII: 35SW5USQ3G)  
    Aluminum Oxide (UNII: LMI26O6933)  
    D&C Red No. 30 (UNII: 2S42T2808B)  
    POLYVINYL ALCOHOL, UNSPECIFIED (UNII: 532B59J990)  
    TALC (UNII: 7SEV7J4R1U)  
    Product Characteristics
    ColorORANGEScoreno score
    ShapeROUNDSize11mm
    FlavorImprint Code MP;28
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC: 57664-690-88100 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product07/14/1987
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA08939907/14/1987
    AMITRIPTYLINE HYDROCHLORIDE 
    amitriptyline hydrochloride tablet, film coated
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC: 57664-691
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Amitriptyline Hydrochloride (UNII: 26LUD4JO9K) (Amitriptyline - UNII:1806D8D52K) Amitriptyline Hydrochloride150 mg
    Inactive Ingredients
    Ingredient NameStrength
    silicon dioxide (UNII: ETJ7Z6XBU4)  
    croscarmellose sodium (UNII: M28OL1HH48)  
    lactose monohydrate (UNII: EWQ57Q8I5X)  
    magnesium stearate (UNII: 70097M6I30)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    titanium dioxide (UNII: 15FIX9V2JP)  
    D&C Yellow No. 10 (UNII: 35SW5USQ3G)  
    Aluminum Oxide (UNII: LMI26O6933)  
    D&C Red No. 30 (UNII: 2S42T2808B)  
    POLYVINYL ALCOHOL, UNSPECIFIED (UNII: 532B59J990)  
    TALC (UNII: 7SEV7J4R1U)  
    Product Characteristics
    ColorORANGE (Peach) Scoreno score
    ShapeOVALSize17mm
    FlavorImprint Code MP;29
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC: 57664-691-88100 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product07/14/1987
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA08939907/14/1987
    Labeler - Sun Pharmaceutical Industries, Inc. (146974886)
    Establishment
    NameAddressID/FEIBusiness Operations
    Frontida BioPharm Inc.080243260MANUFACTURE(57664-687, 57664-688, 57664-689, 57664-692, 57664-690, 57664-691)
    Establishment
    NameAddressID/FEIBusiness Operations
    ALKALOIDA Chemical Company Zrt.643611692MANUFACTURE(57664-687, 57664-688, 57664-689, 57664-692, 57664-690, 57664-691)

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