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Amoxapine (Amoxapine) - Indications and Dosage

 
 



INDICATIONS AND USAGE

Amoxapine is indicated for the relief of symptoms of depression in patients with neurotic or reactive depressive disorders as well as endogenous and psychotic depressions. It is indicated for depression accompanied by anxiety or agitation.

DOSAGE AND ADMINISTRATION

Effective dosage of amoxapine may vary from one patient to another. Usual effective dosage is 200 to 300 mg daily. Three weeks constitutes an adequate period of trial providing dosage has reached 300 mg daily (or lower level of tolerance) for at least two weeks. If no response is seen at 300 mg, dosage may be increased, depending upon tolerance, up to 400 mg daily. Hospitalized patients who have been refractory to antidepressant therapy and who have no history of convulsive seizures may have dosage raised cautiously up to 600 mg daily in divided doses.

Amoxapine may be given in a single daily dose, not to exceed 300 mg, preferably at bedtime. If the total daily dosage exceeds 300 mg, it should be given in divided doses.

Initial Dosage for Adults

Usual starting dosage is 50 mg two or three times daily. Depending upon tolerance, dosage may be increased to 100 mg two or three times daily by the end of the first week. (Initial dosage of 300 mg daily may be given, but notable sedation may occur in some patients during the first few days of therapy at this level.) Increases above 300 mg daily should be made only if 300 mg daily has been ineffective during a trial period of at least two weeks. When effective dosage is established, the drug may be given in a single dose (not to exceed 300 mg) at bedtime.

Elderly Patients

In general, lower dosages are recommended for these patients. Recommended starting dosage of amoxapine is 25 mg two or three times daily. If no intolerance is observed, dosage may be increased by the end of the first week to 50 mg two or three times daily. Although 100 to 150 mg daily may be adequate for many elderly patients, some may require higher dosage. Careful increases up to 300 mg daily are indicated in such cases.

Once an effective dosage is established, amoxapine may conveniently be given in a single bedtime dose, not to exceed 300 mg.

Maintenance

Recommended maintenance dosage of amoxapine is the lowest dose that will maintain remission. If symptoms reappear, dosage should be increased to the earlier level until they are controlled.

For maintenance therapy at dosages of 300 mg or less, a single dose at bedtime is recommended.

HOW SUPPLIED

Amoxapine Tablets USP, 25 mg are 8/32", scored, round, white tablets imprinted DAN 25 and 5713 supplied in bottles of 100.

Amoxapine Tablets USP, 50 mg are 10/32", scored, round, orange tablets imprinted DAN 50 and 5714 supplied in bottles of 100.

Amoxapine Tablets USP, 100 mg are 11/32", scored, round, blue tablets imprinted DAN 100 and 5715 supplied in bottles of 100.

Amoxapine Tablets USP, 150 mg are 12/32", scored, round, orange tablets imprinted DAN 150 and 5716 supplied in bottles of 30.

Dispense in a tight container with child-resistant closure.

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

Manufactured by: Watson Laboratories, Inc.
                           Corona, CA 92880 USA

Distributed by:     Watson Pharma, Inc.
                           Corona, CA 92880 USA

Revised: June 2008
0608B

Medication Guide

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:

  • all risks and benefits of treatment with antidepressant medicines

  • all treatment choices for depression or other serious mental illness

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

  • Antidepressant medicines may increase suicidal thoughts or actions in some children, teenagers, and young adults within the first few months of treatment.

  • Depression and other serious mental illnesses are the most important causes of suicidal thoughts and actions. Some people may have a particularly high risk of having suicidal thoughts or actions. These include people who have (or have a family history of) bipolar illness (also called manic-depressive illness) or suicidal thoughts or actions.

  • How can I watch for and try to prevent suicidal thoughts and actions in myself or a family member?

      Pay close attention to any changes, especially sudden changes, in mood, behaviors, thoughts, or feelings. This is very important when an antidepressant medicine is started or when the dose is changed.

    • Call the healthcare provider right away to report new or sudden changes in mood, behavior, thoughts, or feelings.

    • Keep all follow-up visits with the healthcare provider as scheduled. Call the healthcare provider between visits as needed, especially if you have concerns about symptoms.

Call a healthcare provider right away if you or your family member has any of the following symptoms, especially if they are new, worse, or worry you:

  • thoughts about suicide or dying

  • attempts to commit suicide

  • new or worse depression

  • new or worse anxiety

  • feeling very agitated or restless

  • panic attacks

  • trouble sleeping (insomnia)

  • new or worse irritability

  • acting aggressive, being angry, or violent

  • acting on dangerous impulses

  • an extreme increase in activity and talking (mania)

  • other unusual changes in behavior or Mood

What else do I need to know about antidepressant medicines?

  • Never stop an antidepressant medicine without first talking to a healthcare provider. Stopping an antidepressant medicine suddenly can cause other symptoms.

  • Antidepressants are medicines used to treat depression and other illnesses. It is important to discuss all the risks of treating depression and also the risks of not treating it. Patients and their families or other caregivers should discuss all treatment choices with the healthcare provider, not just the use of antidepressants.

  • Antidepressant medicines have other side effects. Talk to the healthcare provider about the side effects of the medicine prescribed for you or your family member.

  • Antidepressant medicines can interact with other medicines. Know all of the medicines that you or your family member takes. Keep a list of all medicines to show the healthcare provider. Do not start new medicines without first checking with your healthcare provider.

  • Not all antidepressant medicines prescribed for children are FDA approved for use in children. Talk to your child’s healthcare provider for more information.

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.

Manufactured by: Watson Laboratories, Inc.
                           Corona, CA 92880 USA

Distributed by:     Watson Pharma, Inc.
                           Corona, CA 92880 USA

Revised: June 2008

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