WHAT IS DULESTER?
Dulester is a selective serotonin and norepinephrine reuptake inhibitor antidepressant (SSNRI). Dulester affects chemicals in the brain that may become unbalanced and cause depression.
Dulester is used to treat major depressive disorder in adults. Dulester is also used to treat general anxiety disorder in adults and children who are at least 7 years old.
Dulester is also used in adults to treat fibromyalgia (a chronic pain disorder), or chronic muscle or joint pain (such as low back pain and osteoarthritis pain).
Dulester is also used to treat pain caused by nerve damage in adults with diabetes (diabetic neuropathy).
Dulester may also be used for purposes not listed in this medication guide.
Dulester is indicated for the treatment of:
Major Depressive Disorder
Generalized Anxiety Disorder
Diabetic Peripheral Neuropathy
Fibromyalgia
Chronic Musculoskeletal Pain
HOW SHOULD I USE DULESTER?
Use Dulester delayed-release capsules as directed by your doctor. Check the label on the medicine for exact dosing instructions.
Dulester delayed-release capsules comes with an extra patient information sheet called a Medication Guide. Read it carefully. Read it again each time you get Dulester delayed-release capsules refilled.
Take Dulester delayed-release capsules by mouth with or without food. Taking it with food may help to decrease the chance of nausea or stomach upset.
Swallow Dulester delayed-release capsules whole. Do not break, crush, or chew before swallowing. Do not open the capsule and sprinkle the contents on food or in liquid.
Take Dulester delayed-release capsules on a regular schedule to get the most benefit from it. Taking Dulester delayed-release capsules at the same time each day will help you remember to take it.
Continue to take Dulester delayed-release capsules even if you feel well. Do not miss any doses.
Do not suddenly stop taking Dulester delayed-release capsules without checking with your doctor. Side effects may occur. They may include anxiety, numbness or tingling of the skin, diarrhea, dizziness, headache, increased sweating, irritability, nausea, trouble sleeping, unusual tiredness, or vomiting. If you need to stop Dulester delayed-release capsules, your doctor may need to gradually lower your dose.
If you miss a dose of Dulester delayed-release capsules, 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.
Ask your health care provider any questions you may have about how to use Dulester delayed-release capsules.
DULESTER DOSAGE
Swallow Dulester whole. Do not chew or crush. Do not open the capsule and sprinkle its contents on food or mix with liquids. All of these might affect the enteric coating. Dulester can be given without regard to meals. If a dose of Dulester is missed, take the missed dose as soon as it is remembered. If it is almost time for the next dose, skip the missed dose and take the next dose at the regular time. Do not take two doses of Dulester at the same time.
Dosage For Treatment Of Major Depressive Disorder
Administer Dulester at a total dose of 40 mg/day (given as 20 mg twice daily) to 60 mg/day (given either once daily or as 30 mg twice daily). For some patients, it may be desirable to start at 30 mg once daily for 1 week, to allow patients to adjust to the medication before increasing to 60 mg once daily. While a 120 mg/day dose was shown to be effective, there is no evidence that doses greater than 60 mg/day confer any additional benefits. The safety of doses above 120 mg/day has not been adequately evaluated. Periodically reassess to determine the need for maintenance treatment and the appropriate dose for such treatment.
Dosage For Treatment Of Generalized Anxiety Disorder
Adults
For most patients, initiate Dulester 60 mg once daily. For some patients, it may be desirable to start at 30 mg once daily for 1 week, to allow patients to adjust to the medication before increasing to 60 mg once daily. While a 120 mg once daily dose was shown to be effective, there is no evidence that doses greater than 60 mg/day confer additional benefit. Nevertheless, if a decision is made to increase the dose beyond 60 mg once daily, increase dose in increments of 30 mg once daily. The safety of doses above 120 mg once daily has not been adequately evaluated. Periodically reassess to determine the continued need for maintenance treatment and the appropriate dose for such treatment.
Elderly
Initiate Dulester at a dose of 30 mg once daily for 2 weeks before considering an increase to the target dose of 60 mg. Thereafter, patients may benefit from doses above 60 mg once daily. If a decision is made to increase the dose beyond 60 mg once daily, increase dose in increments of 30 mg once daily. The maximum dose studied was 120 mg per day. Safety of doses above 120 mg once daily has not been adequately evaluated.
Dulester side effects
The following serious adverse reactions are described below and elsewhere in the labeling:
Suicidal Thoughts and Behaviors in Children, Adolescents and Young Adults
Hepatotoxicity
Orthostatic Hypotension, Falls and Syncope
Serotonin Syndrome
Abnormal Bleeding
Severe Skin Reactions
Discontinuation of Treatment with Dulester
Activation of Mania/Hypomania
Angle-Closure Glaucoma
Seizures
Effect on Blood Pressure
Clinically Important Drug Interactions
Hyponatremia
Urinary Hesitation and Retention
