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Description

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.

Trazodone is available only with your doctor's prescription.

This product is available in the following dosage forms:

• Tablet

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Before Using

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

Trazodone must be used with caution in children with depression. Studies have shown occurrences of children thinking about suicide or attempting suicide in clinical trials for this medicine. More study is needed to be sure trazodone is safe and effective in children

Geriatric

Drowsiness, dizziness, confusion, vision problems, dryness of mouth, and constipation may be more likely to occur in the elderly, who are usually more sensitive to the effects of trazodone.

Pregnancy

Breastfeeding

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.

Drug Interactions

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.

• Amiodarone
• Droperidol
• Fluoxetine
• Ginkgo
• Linezolid
• Paroxetine
• St John's Wort
• Venlafaxine

Other Interactions

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. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

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:

• Alcohol abuse (or history of)—Drinking alcohol with trazodone will increase the central nervous system (CNS) depressant effects

• Heart disease—Trazodone may make the condition worse

• Kidney disease or
• Liver disease—Higher blood levels of trazodone may occur, increasing the chance of side effects

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Proper Use

To lessen stomach upset and to reduce dizziness and lightheadedness, take this medicine with or shortly after a meal or light snack, even for a daily bedtime dose, unless your doctor has told you to take it on an empty stomach.

Take trazodone only as directed by your doctor, to benefit your condition as much as possible.

Sometimes trazodone must be taken for up to 4 weeks before you begin to feel better, although most people notice improvement within 2 weeks.

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.

• Adults—Oral, to start, 50 milligrams per dose taken three times a day, or 75 milligrams per dose taken two times a day. Your doctor may increase your dose if needed.
• Children 6 to 18 years of age—Oral. Your doctor will tell you what dose to take based on your body weight.
• Children up to 6 years of age—Dose must be determined by the doctor.
• Elderly patients—Oral, to start, 25 milligrams per dose taken three times a day. Your doctor may increase your dose if needed.

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.

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Precautions

It is very important that your doctor check your progress at regular visits. This will allow your doctor to check the medicine's effects and to change the dose if needed.

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 reduce gradually the amount of medicine you are using before you stop completely.

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 medicines that are used during surgery or dental or emergency treatments may increase the CNS depressant effects.

Trazodone may cause some people to be agitated, irritable or display other abnormal behaviors. It may also cause some people to have suicidal thoughts and tendencies or to become more depressed. If you or your caregiver notice any of these adverse effects, tell your doctor right away.

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

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 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.

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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.

Stop taking this medicine and get emergency help immediately if any of the following effects occur:

• Painful, inappropriate erection of the penis, continuing

Check with your doctor as soon as possible if any of the following side effects occur:

• Confusion
• Fainting
• Muscle tremors

• Fast or slow heartbeat
• Skin rash
• Unusual excitement

• Drowsiness
• Loss of muscle coordination
• Nausea and vomiting

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:

• Dizziness or lightheadedness
• Drowsiness
• Dryness of mouth (usually mild)
• Headache
• Nausea and vomiting
• Unpleasant taste

• Blurred vision
• Constipation
• Diarrhea
• Muscle aches or pains
• Unusual tiredness or weakness

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

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