Generic Name : Tramadol hydrochloride

Brand name: Ultram, Tramal

Manufacturer: Sanofi-Grunenthal

Why is Ultram prescribed?

Ultram is prescribed to relieve moderate to moderately severe pain.

Most important fact about Ultram

You should not drive a car, operate machinery, or perform any other potentially hazardous activities until you know how Ultram affects you.

How should you take Ultram?

It's important to take Tramadol hydrochloride exactly as prescribed. Do not increase the dosage or length of time you take Tramadol hydrochloride without your doctor's approval.

--If you miss a dose...

Take it as soon as you remember. However, if it is almost time for your next dose, skip the one you missed and go back to your regular schedule. Never take 2 doses at once.

--Storage information...

Store in a tightly closed container at room temperature.

What side effects may occur?

Side effects cannot be anticipated. If any develop or change in intensity, tell your doctor as soon as possible. Only your doctor can determine if it is safe for you to continue taking Ultram.

More common side effects may include:

 Agitation, anxiety, bloating and gas, constipation, convulsive movements, diarrhea, dizziness, drowsiness, dry mouth, feeling of elation, hallucinations, headache, indigestion, itching, nausea, nervousness, sweating, tremor, vomiting, weakness

Less common side effects may include:

 Abdominal pain, confusion, coordination problems, feeling of illness, flushing, frequent urination, inability to urinate, loss of appetite, menopausal symptoms, rash, sleeping problems, visual problems

Rare side effects may include: .

 Accidental injury, allergic reaction, altered taste, amnesia, coma, difficult or labored breathing, difficulty concentrating, dizziness or light-headedness upon standing, fainting, feeling of "pins and needles," fever, heightened reflexes, hives, menstrual problems, mental sluggishness or clouding, painful urination, rapid heartbeat, seizures, shivering, seizures, suicidal tendencies, weight loss

Why should Ultram not be prescribed?

Avoid Tramadol hydrochloride if it has ever given you an allergic reaction. Also avoid Ultram after taking large doses of sleeping pills such as Halcion, Dalmane, and Restoril; narcotic pain relievers such as Demerol, morphine, Darvon, and Percocet; or psychotherapeutic drugs such as antidepressants and tranquilizers. And do not take Ultram after drinking excessive amounts of alcohol.

Special warnings about Ultram.

If you have stomach problems such as an ulcer, make sure your doctor is aware of them. Ultram may hide the symptoms, making them difficult to diagnose and treat.

Ultram can cause mental and physical addiction. If you've ever had a problem with narcotic painkillers such as Percocet, Demerol, or morphine, you should avoid this drug. Withdrawal symptoms may occur if you stop taking Ultram abruptly. Such symptoms include anxiety, sweating, insomnia, pain, nausea, tremor, diarrhea, and respiratory problems. A gradual decrease in dosage will help prevent these symptoms.

Possible food and drug interactions.

 when taking Ultram?

Ultram may increase the drowsiness caused by alcohol. Do not drink alcohol while taking Tramadol hydrochloride.

Avoid Ultram, too, if you are taking the seizure medication Tegretol.

If Ultram is taken with certain other drugs, the effects of either could be increased, decreased, or altered. It is especially important to check with your doctor before combining Ultram with the following:

* Cyclobenzaprine (Flexeril)

* Drugs known as MAO inhibitors, including the antidepressants Nardil and Parnate

* Serotonin-boosting antidepressants such as Paxil, Prozac, and Zoloft

 "Tricyclic" antidepressants such as Elavil, Norpramin, and Tofranil

* Major tranquilizers such as Thorazine and Stelazine

* Narcotic pain relievers (Demerol, morphine, Darvon, Percocet)

* Promethazine (Mepergan, Phenergan)

* Quinidine (Quinidex)

* Sleeping pills (Halcion, Dalmane, Restoril)

* Tranquilizers (Valium, Xanax)

Special information

 if you are pregnant or breastfeeding

There have been reports of serious harm to developing babies when Ultram was used during pregnancy. If you are pregnant or plan to become pregnant, tell your doctor immediately.

Ultram appears in breast milk and may affect a nursing infant. If Ultram is essential to your health, your doctor may advise you to discontinue breastfeeding until your treatment is finished.

Recommended dosage

ADULTS

The usual starting dose for chronic pain is 25 milligrams once a day in the morning. The daily dosage is then increased every 3 days until it reaches 200 milligrams taken in four doses of 50 milligrams each. After the phase-in period, Ultram may be taken in doses of 50 to 100 milligrams every 4 to 6 hours, depending on the severity of pain. If rapid pain relief is needed, the phase-in steps can be skipped, though side effects will be more likely. The maximum dosage under any circumstances is 400 milligrams a day (300 milligrams for those over age 75).

For people with kidney problems, the usual starting dose is 50 to 100 milligrams every 12 hours; and the maximum per day is 200 milligrams. For those with cirrhosis, the usual dose is 50 milligrams every 12 hours.

CHILDREN

Safety and effectiveness in children under 16 years of age have not been established.

Overdosage

An overdose of Ultram can be fatal. If you suspect an overdose, seek emergency medical treatment immediately.

Symptoms of Ultram overdose include:

 Difficult or slowed breathing, drowsiness, coma, seizures, cardiac arrest