DOXEPIN HYDROCHLORIDE (Page 4 of 4)

Pediatric Management

The principles of management of child 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

For most patients with illness of mild to moderate severity, a starting daily dose of 75 mg is recommended. Dosage may subsequently be increased or decreased at appropriate intervals and according to individual response. The usual optimum dose range is 75 mg/day to 150 mg/day.

In more severely ill patients higher doses may be required with subsequent gradual increase to 300 mg/day if necessary. Additional therapeutic effect is rarely to be obtained by exceeding a dose of 300 mg/day.

In patients with very mild symptomatology or emotional symptoms accompanying organic disease, lower doses may suffice. Some of these patients have been controlled on doses as low as 25 to 50 mg/day.

The total daily dosage of doxepin hydrochloride may be given on a divided or once-a-day dosage schedule. If the once-a-day schedule is employed, the maximum recommended dose is 150 mg/day. This dose may be given at bedtime.

Anti-anxiety effect is apparent before the antidepressant effect. Optimal antidepressant effect may not be evident for two to three weeks.

HOW SUPPLIED

Doxepin Hydrochloride Oral Solution, USP (Concentrate), a clear colorless liquid, is available in 4 fl oz (118 mL) containers, with an accompanying dropper calibrated at 5 mg, 10 mg, 15 mg, 20 mg, and 25 mg. Each mL contains doxepin hydrochloride equivalent to 10 mg doxepin. Immediately prior to taking this medication, dilute each dose with approximately 120 mL (4 ounces) of water, whole or skimmed milk, or orange, grapefruit, tomato, prune or pineapple juice. Doxepin hydrochloride oral solution (concentrate) is not physically compatible with a number of carbonated beverages. For those patients requiring antidepressant therapy who are on methadone maintenance, doxepin hydrochloride oral solution (concentrate) and methadone syrup can be mixed together with Gatorade® , lemonade, orange juice, sugar water, Tang® , or water; but not with grape juice. Preparation and storage of bulk dilutions is not recommended.

RECOMMENDED STORAGE

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

Rx Only

Product No.: 8651

Manufactured For: Wockhardt USA, LLC

Parsippany, NJ 07054

Manufactured By:

Morton Grove Pharmaceuticals, Inc.

Morton Grove, IL 60053

28651

REV. 09-18

PHARMACIST — PATIENT MEDICATION GUIDE PROVIDED BELOW

Medication Guide

Doxepin Hydrochloride Oral Solution, USP (Concentrate)

10 mg/mL

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

Read the Medication Guide that comes with your 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?

  1. Antidepressant medicines may increase suicidal thoughts or actions in some children, teenagers, and young adults within the first few months of treatment.
  2. 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.
  3. 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
  • visual problems: eye pain, changes in vision, swelling and redness around the eye

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.
  • Visual problems: Only some people are at risk for these problems. You may want to undergo an eye examination to see if you are at risk and receive preventative treatment if you are.
  • 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.

Product No.: 8651

Manufactured For:

Wockhardt USA, LLC

Parsippany, NJ 07054

Manufactured By:

Morton Grove Pharmaceuticals, Inc.

Morton Grove, IL 60053

28651A

REV. 09-18

PRINCIPAL DISPLAY PANEL – 118 mL Bottle Carton

MGP

NDC 60432-651-04

Doxepin

Hydrochloride

Oral Solution,

USP

(Concentrate)

10 mg/mL

ATTENTION PHARMACIST:

Dispense the Medication Guide

provided separately to each patient.

SAFETY SEALED BOTTLE

Rx Only

NET: 4 fl oz (118 mL)

Doxepin Hydrochloride Oral Solution Carton
(click image for full-size original)

Doxepin HCl Oral Solution Carton

DOXEPIN HYDROCHLORIDE
doxepin hydrochloride solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:60432-651
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
DOXEPIN HYDROCHLORIDE (DOXEPIN) DOXEPIN 10 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
WATER
SODIUM BENZOATE
TRISODIUM CITRATE DIHYDRATE
ANHYDROUS CITRIC ACID
SORBITOL
GLYCERIN
PROPYLENE GLYCOL
POLYETHYLENE GLYCOL 400
PEPPERMINT OIL
CITRIC ACID MONOHYDRATE
Product Characteristics
Color Score
Shape Size
Flavor PEPPERMINT Imprint Code
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:60432-651-04 118 mL in 1 BOTTLE, PLASTIC None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA071918 02/09/1995
Labeler — Morton Grove Pharmaceuticals, Inc. (801897505)
Registrant — Morton Grove Pharmaceuticals, Inc. (801897505)
Establishment
Name Address ID/FEI Operations
Dipharma Francis S.r.l, Italy 446517344 ANALYSIS (60432-651), API MANUFACTURE (60432-651)
Establishment
Name Address ID/FEI Operations
Morton Grove Pharmaceuticals, Inc. 801897505 ANALYSIS (60432-651), LABEL (60432-651), MANUFACTURE (60432-651), PACK (60432-651)

Revised: 11/2018 Morton Grove Pharmaceuticals, Inc.

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