Desyrel Dividose

Generic Name: trazodone (Oral route)

TRAZ-oh-done

Oral route(Tablet;Tablet, Extended Release)

Antidepressants increased the risk of suicidal thinking and behavior in children, adolescents, and young adults in short-term studies with major depressive disorder (MDD) and other psychiatric disorders. Short term studies did not show an increase in the risk of suicidality with antidepressants compared to placebo in adults beyond age 24, and there was a reduction in risk with antidepressants compared to placebo in adults aged 65 and older. This risk must be balanced with the clinical need. Monitor patients closely for clinical worsening, suicidality, or unusual changes in behavior. Families and caregivers should be advised of the need for close observation and communication with the prescriber. Not approved for use in pediatric patients .

Commonly used brand name(s)

In the U.S.

• Desyrel


• Desyrel Dividose


• Oleptro

Available Dosage Forms:

• Tablet


• Tablet, Extended Release

Therapeutic Class: Antidepressant

Chemical Class: Triazolopyridine

Uses For Desyrel Dividose

Trazodone belongs to the group of medicines known as antidepressants or "mood elevators". It is used to relieve mental depression, and depression that sometimes occurs with anxiety.

This medicine is available only with your doctor's prescription.

Before Using Desyrel Dividose

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Appropriate studies have not been performed on the relationship of age to the effects of trazodone in the pediatric population. Safety and efficacy have not been established.

Geriatric

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of trazodone extended-release tablets in the elderly. However, elderly patients are more likely to have hyponatremia (low sodium in the blood), which may require caution in patients receiving trazodone.

No information is available on the relationship of age to the effects of trazodone regular tablets in the elderly.

Pregnancy

	Pregnancy Category	Explanation
All Trimesters	C	Animal studies have shown an adverse effect and there are no adequate studies in pregnant women OR no animal studies have been conducted and there are no adequate studies in pregnant women.

Breast Feeding

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Interactions with Medicines

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.

• Cisapride


• Dronedarone


• Linezolid


• Metoclopramide


• Pimozide


• Posaconazole


• Saquinavir


• Sparfloxacin

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Alfuzosin


• Amiodarone


• Amitriptyline


• Amoxapine


• Apomorphine


• Arsenic Trioxide


• Asenapine


• Astemizole


• Azithromycin


• Chloroquine


• Ciprofloxacin


• Citalopram


• Clomipramine


• Clozapine


• Crizotinib


• Dasatinib


• Desipramine


• Disopyramide


• Dofetilide


• Dolasetron


• Droperidol


• Duloxetine


• Erythromycin


• Flecainide


• Fluconazole


• Fluoxetine


• Gatifloxacin


• Gemifloxacin


• Ginkgo


• Granisetron


• Halofantrine


• Haloperidol


• Ibutilide


• Iloperidone


• Imipramine


• Lapatinib


• Levofloxacin


• Lopinavir


• Lumefantrine


• Mefloquine


• Methadone


• Methylene Blue


• Moxifloxacin


• Nilotinib


• Norfloxacin


• Nortriptyline


• Octreotide


• Ondansetron


• Paliperidone


• Paroxetine


• Pazopanib


• Perflutren Lipid Microsphere


• Procainamide


• Propafenone


• Protriptyline


• Quetiapine


• Quinidine


• Quinine


• Ranolazine


• Salmeterol


• Sodium Phosphate


• Sodium Phosphate, Dibasic


• Sodium Phosphate, Monobasic


• Solifenacin


• Sorafenib


• Sotalol


• St John's Wort


• Sunitinib


• Telithromycin


• Terfenadine


• Tetrabenazine


• Toremifene


• Trimipramine


• Vandetanib


• Vardenafil


• Vemurafenib


• Venlafaxine


• Voriconazole


• Ziprasidone

Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Atazanavir


• Carbamazepine


• Chlorpromazine


• Clarithromycin


• Digoxin


• Foxglove


• Indinavir


• Itraconazole


• Ketoconazole


• Nefazodone


• Phenytoin


• Ritonavir


• Thioridazine


• Tipranavir


• Trifluoperazine

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Other Medical Problems

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

• Bipolar disorder (mood disorder with alternating episodes of mania and depression), or risk of or


• Bleeding problems or


• Heart attack, recent or history of or


• Heart disease or


• Heart rhythm problems (e.g., QT prolongation) or


• Hyponatremia (low sodium in the blood) or


• Hypotension (low blood pressure) or


• Priapism (painful or prolonged erection of the penis)—Use with caution. May make these conditions worse.

• Kidney disease or


• Liver disease—Use with caution. The effects may be increased because of slower removal of the medicine from the body.

Proper Use of trazodone

This section provides information on the proper use of a number of products that contain trazodone. It may not be specific to Desyrel Dividose. Please read with care.

Take this medicine only as directed by your doctor. Do not take more of it, do not take it more often, and do not take it for a longer time than your doctor ordered.

This medicine should come with a medication guide. Read and follow these instructions carefully. Talk with your doctor if you have any questions.

To lessen stomach upset and to reduce dizziness and lightheadedness, take the regular tablets with or shortly after a meal or light snack, unless your doctor tells you otherwise.

Take the extended-release tablets at the same time each day, preferably at bedtime, without food.

The tablets can be swallowed whole or given as a half tablet by breaking the tablet along the score line. Do not break the tablets unless your doctor tells you to. Do not crush or chew the tablets.

Dosing

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

• For depression:
  
  • For oral dosage form (extended-release tablets):
    
    • Adults—At first, 150 milligrams (mg) once a day. Your doctor may adjust your dose as needed. However, the dose is usually not more than 375 mg per day.
    
    
    • Children—Use and dose must be determined by your doctor.
    
    
  
  
  • For oral dosage form (tablets):
    
    • Adults—At first, 150 milligrams (mg) per day, given in divided doses. Your doctor may adjust your dose as needed. However, the dose is usually not more than 400 mg per day.
    
    
    • Children—Use and dose must be determined by your doctor.
    
    
  
  

Missed Dose

If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Precautions While Using Desyrel Dividose

It is very important that your doctor check your progress at regular visits, to allow for changes in your dose and to help manage any side effects.

Do not stop taking this medicine without first checking with your doctor. To prevent a possible return of your medical problem, your doctor may want you to gradually reduce the amount of medicine you are using before you stop completely.

This medicine will add to the effects of alcohol and other CNS depressants (medicines that make you drowsy or less alert). Some examples of CNS depressants are antihistamines or medicine for allergies or colds; sedatives, tranquilizers or sleeping medicine; prescription pain medicine or narcotics; medicine for seizures or barbiturates; muscle relaxants; or anesthetics, including some dental anesthetics. Check with your doctor before taking any of the above while you are using this medicine.

Before having any kind of surgery, dental treatment, or emergency treatment, tell the medical doctor or dentist in charge that you are using this medicine. Taking trazodone together with anesthetic medicines (numbing medicines) that are used during surgery, dental treatments, or emergency treatments may cause an increase in CNS depressant effects.

For some teenagers and young adults, this medicine can increase thoughts of suicide. Tell your doctor right away if you start to feel more depressed or have thoughts about hurting yourself or others. Report any unusual thoughts or behaviors that trouble you, especially if they are new or get worse quickly. Make sure the doctor knows if you have trouble sleeping, get upset easily, have a big increase in energy, or start to act reckless. Also tell the doctor if you have sudden or strong feelings, such as feeling nervous, angry, restless, violent, or scared. Let the doctor know if you or anyone in your family have bipolar disorder (manic-depressive disorder) or have tried to commit suicide.

Make sure your doctor knows about all the other medicines you are using. This medicine may cause two serious conditions called serotonin syndrome and neuroleptic malignant syndrome (NMS)-like reactions when taken with certain medicines that are also used for depression, mental conditions, or migraines. Check with your doctor first before taking any other medicines. Stop taking this medicine and tell your doctor right away if you have more than one of the following symptoms: agitation; confusion; diarrhea; difficulty with breathing; a fast heartbeat; a high fever; high or low blood pressure; loss of bladder control; muscle twitching; overactive reflexes; poor coordination; restlessness; seizures; severe muscle stiffness; shivering; sweating; talking or acting with excitement; trembling or shaking that you are unable to control; unusually pale skin; or tiredness.

This medicine can cause changes in the heart rhythm, such as a condition called QT prolongation. It may change the way your heart beats, and cause fainting or serious side effects in some patients. Contact your doctor right away if you have any symptoms of heart rhythm problems, such as fast, pounding, or irregular heartbeats.

This medicine may cause some people to become drowsy or less alert than they are normally. Make sure you know how you react to this medicine before you drive, use machines, or do anything else that could be dangerous if you are not alert.

Dizziness, lightheadedness, or fainting may occur, especially when you get up suddenly from a lying or sitting position. Getting up slowly may help. If this problem continues or gets worse, check with your doctor.

Trazodone may cause dryness of the mouth. For temporary relief, use sugarless gum or candy, melt bits of ice in your mouth, or use a saliva substitute. However, if your mouth continues to feel dry for more than 2 weeks, check with your medical doctor or dentist. Continuing dryness of the mouth may increase the chance of dental disease, including tooth decay, gum disease, and fungus infections.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

Desyrel Dividose Side Effects

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

More common

• Blurred vision


• confusion


• dizziness


• dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position


• lightheadedness


• sweating


• unusual tiredness or weakness

Less common

• Burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings


• confusion about identity, place, and time


• decreased concentration


• fainting


• general feeling of discomfort or illness


• headache


• lack of coordination


• muscle tremors


• nervousness


• pounding in the ears


• shortness of breath


• slow or fast heartbeat


• swelling

Rare

• Skin rash


• unusual excitement

Get emergency help immediately if any of the following symptoms of overdose occur:

Symptoms of overdose

• Drowsiness


• loss of muscle coordination


• nausea and vomiting


• painful, inappropriate erection of the penis, continuing

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common

• Dryness of the mouth (usually mild)


• muscle or bone pain


• sleeplessness


• trouble with remembering


• trouble with sleeping


• unable to sleep


• unpleasant taste

Less common

• Constipation


• continuing ringing or buzzing or other unexplained noise in the ears


• diarrhea


• hearing loss


• muscle aches or pains


• weight loss

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

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

See also: Desyrel Dividose side effects (in more detail)

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More Desyrel Dividose resources

• Desyrel Dividose Side Effects (in more detail)
• Desyrel Dividose Use in Pregnancy & Breastfeeding
• Drug Images
• Desyrel Dividose Drug Interactions
• Desyrel Dividose Support Group
• 1 Review for Desyrel Dividose - Add your own review/rating

• Desyrel Prescribing Information (FDA)


• Desyrel MedFacts Consumer Leaflet (Wolters Kluwer)


• Oleptro Prescribing Information (FDA)


• Oleptro Extended-Release Tablets MedFacts Consumer Leaflet (Wolters Kluwer)


• Oleptro Consumer Overview


• Trazodone Prescribing Information (FDA)


• Trazodone Hydrochloride Monograph (AHFS DI)

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