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Tramadol

Generic Name: tramadol (TRAM a dol)
Brand Names: Ultram, Ultram ER

Tramadol is a narcotic-like pain reliever.

Tramadol is used to treat moderate to severe pain. Tramadol extended-release is used to treat moderate to severe chronic pain when treatment is needed around the clock.

Tramadol may also be used for other purposes not listed in this medication guide.

Tramadol Medication Description

ULTRAM® (tramadol hydrochloride) tablets is a centrally
acting analgesic. The chemical name for tramadol hydrochloride is (±)cis-2-[(dimethylamino)methyl]-1-(3methoxyphenyl)
cyclohexanol hydrochloride. Its structural formula is:

tramadol

The molecular weight of tramadol hydrochloride is 299.8.
Tramadol hydrochloride is a white, bitter, crystalline and odorless powder. It
is readily soluble in water and ethanol and has a pKa of 9.41. The
n-octanol/water log partition coefficient (logP) is 1.35 at pH 7. ULTRAM®
tablets contain 50 mg of tramadol hydrochloride and are white in color.
Inactive ingredients in the tablet are pregelatinized corn starch, modified
starch (corn), hypromellose, lactose, magnesium stearate, microcrystalline
cellulose, polyethylene glycol, polysorbate 80, sodium starch glycolate,
titanium dioxide and carnauba wax.

How should I take tramadol?

Take tramadol exactly as it was prescribed for you. Do not take it in larger doses or for longer than recommended by your doctor. Follow the directions on your prescription label. Do not take more than 300 milligrams of tramadol in one day.

Take this medication with a full glass of water.

Tramadol can be taken with or without food, but take it the same way each time.

Do not crush the tramadol tablet. This medicine is for oral (by mouth) use only. Powder from a crushed tablet should not be inhaled or diluted with liquid and injected into the body. Using this medicine by inhalation or injection can cause life-threatening side effects, overdose, or death. Do not crush, chew, break, or open a controlled-release, delayed-release, or extended-release tablet or capsule. Swallow the pill whole. Breaking or opening the pill may cause too much of the drug to be released at one time.

If you use the tramadol extended-release tablet, the tablet shell may pass into your stools (bowel movements). This is normal and does not mean that you are not receiving enough of the medicine.

Tramadol may be habit-forming. Tell your doctor if you feel the medicine is not working as well in relieving your pain. Do not change your dose without talking to your doctor. Do not stop using tramadol suddenly, or you could have unpleasant withdrawal symptoms such as anxiety, sweating, nausea, diarrhea, tremors, chills, hallucinations, trouble sleeping, or breathing problems. Talk to your doctor about how to avoid withdrawal symptoms when stopping the medication. Store tramadol at room temperature away from moisture and heat. Keep track of how many pills have been used from each new bottle of this medicine. Tramadol is a drug of abuse and you should be aware if any person in the household is using this medicine improperly or without a prescription.

Before taking tramadol

You should not take tramadol if you have ever been addicted to drugs or alcohol, if you are currently intoxicated (drunk), or if you have recently used any of the following drugs:

• alcohol;
• narcotic pain medicine;
• sedatives or tranquilizers (such as Valium);
• medicine for depression or anxiety;
• medicine for mental illness (such as bipolar disorder, schizophrenia); or
• street drugs.

Seizures have occurred in some people taking tramadol. Your risk of a seizure may be higher if you have any of these conditions:

• a history of drug or alcohol addiction;
• a history of epilepsy or other seizure disorder;
• a history of head injury;
• a metabolic disorder; or
• if you are also taking an antidepressant, muscle relaxer, or medicine for nausea and vomiting.

Talk with your doctor about your individual risk of having a seizure while taking tramadol.

Before taking tramadol, tell your doctor if you are allergic to any drugs, or if you have:

• kidney disease;
• liver disease;
• a stomach disorder; or
• a history of depression, mental illness, or suicide attempt.

If you have any of these conditions, you may need a dose adjustment or special tests to safely take tramadol.

FDA pregnancy category C. This medication may be harmful to an unborn baby. Tramadol may also cause serious or fatal side effects in a newborn if the mother uses the medication during pregnancy or labor. Tell your doctor if you are pregnant or plan to become pregnant during treatment. Tramadol can pass into breast milk and may harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby. Tramadol should not be given to a child younger than 18 years of age.

Tramadol Drug Uses

Tramadol is used to relieve moderate to moderately severe pain. It also may be used to treat pain caused by surgery and chronic conditions such as cancer or joint pain. Tramadol works by decreasing the brain’s perception and response to pain. It also reduces the size or magnitude of the pain signal passed from one nerve to another. This medication is sometimes prescribed for other uses; ask your doctor or pharmacist for more information.

How Taken

Tramadol comes as a tablet to take it orally. It usually is taken every 4-6 hours as needed. It may be taken with or without food. Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Take Tramadol exactly as directed. Tramadol can be habit-forming. Do not take a larger dose take it more often, or for a longer period than your doctor tells you to.

Tramadol Warnings/Precautions

Before taking Tramadol, tell your doctor if you have kidney disease; liver disease; or a history of alcohol or drug dependence. You may not be able to take Tramadol, or you may require a dosage adjustment or special monitoring during treatment if you have any of the conditions listed above. Tramadol is in the FDA pregnancy category C. This means that it is not known whether it will be harmful to an unborn baby. Do not take this medication without first talking to your doctor if you are pregnant. It is also not known whether Tramadol passes into breast milk. Do not take Tramadol without first talking to your doctor if you are breast-feeding a baby. If you are over 75 years of age, you may be more likely to experience side effects from Tramadol. The maximum daily dose of Tramadol for people over 75 years of age is 300 mg. Tramadol is not approved by the FDA for use by children younger than 16 years of age.

Missed Dose

Take the missed dose as soon as you remember it. However, if it is almost time for the next dose, skip the missed dose and continue your regular dosing schedule. Do not take a double dose to make up for a missed one.

Tramadol Possible Side Effects

Although side effects from Tramadol are not common, they can occur. The most frequently reported events were in the central nervous system (Migraine, Speech disorders) and gastrointestinal system (Gastrointestinal bleeding, Hepatitis, Stomatitis, Liver failure). Tell your doctor if any of these symptoms are severe or do not go away: dizziness, headache, drowsiness, blurred vision, upset stomach, vomiting, and diarrhea. If you experience any of the following symptoms, call your doctor immediately: fast heartbeat, redness, swelling, and itching of the face, numbness or tingling of the hands and feet, difficulty breathing, changes in urination, seizures.

Tramadol Storage

Dispense in a tight container. Store at 25°C (77°F); excursions permitted to 15 – 30°C (59 – 86°F).

Tramadol Overdose

Seek emergency medical attention. Symptoms of a Tramadol overdose include difficulty breathing; shallow, weak breathing; and seizures.

More Information

Do not drink alcohol while taking Tramadol. Alcohol may cause a dangerous decrease in breathing and/ or liver problems when used during treatment with Tramadol. Use caution when driving, operating machinery, or performing other hazardous activities. Tramadol may cause dizziness or drowsiness. If you experience dizziness or drowsiness, avoid these activities. Avoid sleeping pills, tranquilizers, sedatives, and antihistamines except under the supervision of your doctor. These drugs may increase drowsiness caused by Tramadol. For more detail tramadol information, please check individual pages.

Disclaimer

This drug information is for your information purposes only, it is not intended that this information covers all uses, directions, drug interactions, precautions, or adverse effects of your medication. This is only general information, and should not be relied on for any purpose. It should not be construed as containing specific instructions for any particular patient. We disclaim all responsibility for the accuracy and reliability of this information, and/or any consequences arising from the use of this information, including damage or adverse consequences to persons or property, however such damages or consequences arise. No warranty, either expressed or implied, is made in regards to this information.

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Drug Abuse And Dependence

Tramadol Abuse

Tramadol has mu-opioid agonist activity. ULTRAM can be abused and may be subject to criminal diversion.

Addiction is a primary, chronic, neurobiologic disease, with genetic, psychosocial, and environmental factors influencing its development and manifestations. Drug addiction is characterized by behaviors that include one or more of the following: impaired control over drug use, compulsive use, use for non-medical purposes, and continued use despite harm or risk of harm, and craving. Drug addiction is a treatable disease, utilizing a multidisciplinary approach, but relapse is common.

“Drug-seeking” behavior is very common in addicts and drug abusers. Drug-seeking tactics include emergency calls or visits near the end of office hours, refusal to undergo appropriate examination, testing or referral, repeated “loss” of prescriptions, tampering with prescriptions and reluctance to provide prior medical records or contact information for other treating physician(s). “Doctor shopping” to obtain additional prescriptions is common among drug abusers and people suffering from untreated addiction.

Abuse and addiction are separate and distinct from physical dependence and tolerance. Physicians should be aware that addiction may not be accompanied by concurrent tolerance and symptoms of physical dependence in all addicts. In addition, abuse of ULTRAM® can occur in the absence of true addiction and is characterized by misuse for non-medical purposes, often in combination with other psychoactive substances.

Concerns about abuse and addiction should not prevent the proper management of pain. However all patients treated with opioids require careful monitoring for signs of abuse and addiction, because use of opioid analgesic products carries the risk of addiction even under appropriate medical use.

Proper assessment of the patient and periodic re-evaluation of therapy are appropriate measures that help to limit the potential abuse of this product.

ULTRAM® is intended for oral use only.

Tramadol Dependence

Tolerance is the need for increasing doses of drugs to maintain a defined effect such as analgesia (in the absence of disease progression or other external factors). Physical dependence is manifested by withdrawal symptoms after abrupt discontinuation of a drug or upon administration of an antagonist (see also WARNINGS, Withdrawal).

The opioid abstinence or withdrawal syndrome is characterized by some or all of the following: restlessness, lacrimation, rhinorrhea, yawning, perspiration, chills, myalgia, and mydriasis. Other symptoms also may develop, including irritability, anxiety, backache, joint pain, weakness, abdominal cramps, insomnia, nausea, anorexia, vomiting, diarrhea, or increased blood pressure, respiratory rate, or heart rate.

Generally, tolerance and/or withdrawal are more likely to occur the longer a patient is on continuous therapy with ULTRAM.