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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 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.

Important information about tramadol

You should not take this medication if you are allergic to tramadol, if you have ever been addicted to drugs or alcohol, or if you have ever attempted suicide. Do not take tramadol while you are intoxicated (drunk) or taking any of the following: alcohol or street drugs, narcotic pain medicine, sedatives or tranquilizers, or medicine for depression, anxiety, or mental illness.

Seizures (convulsions) have occurred in some people taking this medicine. Tramadol may be more likely to cause a seizure if you have a history of seizures or head injury, a metabolic disorder, or if you are taking certain medicines such as antidepressants, muscle relaxers, narcotic, or medicine for nausea and vomiting.

Seek emergency medical attention if you think you have used too much of this medicine. A tramadol overdose can be fatal.

Tramadol may be habit-forming and should be used only by the person it was prescribed for. Keep the medication in a secure place where others cannot get to it.

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.

Before taking tramadol

You should not take this medication if you are allergic to tramadol, if you have ever been addicted to drugs or alcohol, or if you have ever attempted suicide.

Do not take tramadol while you are intoxicated (drunk) or taking any of the following:

• alcohol or street drugs;

• narcotic pain medicine;

• sedatives or tranquilizers (such as Valium);

• medicine for depression or anxiety; or

• medicine for mental illness (such as bipolar disorder, schizophrenia).

Seizures have occurred in some people taking tramadol. Talk with your doctor about your seizure risk, which may be higher if you have:

• 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, narcotic, antipsychotic, or medicine for nausea and vomiting.

To make sure you can safely take tramadol, tell your doctor if you have any of these other conditions:

• kidney disease (or if you are on dialysis);

• cirrhosis or other liver disease;

• a stomach disorder; or

• a history of depression, mental illness, or thoughts of suicide.

Tramadol may be habit forming and should be used only by the person it was prescribed for. Never share tramadol with another person, especially someone with a history of drug abuse or addiction. Keep the medication in a place where others cannot get to it.

FDA pregnancy category C. It is not known whether tramadol will harm an unborn baby. Tramadol may cause serious or fatal side effects in a newborn if the mother uses this medication during pregnancy or labor. Tell your doctor if you are pregnant or plan to become pregnant while using this medication. Tramadol can pass into breast milk and may harm a nursing baby. You should not breast-feed while you are taking tramadol. Do not give this medication to anyone younger than 16 years old without the advice of a doctor.

Rybix ODT may contain phenylalanine. Talk to your doctor before using this form of tramadol if you have phenylketonuria (PKU).

How should I take tramadol?

Take tramadol exactly as prescribed. Never take tramadol in larger amounts, or for longer than recommended by your doctor. Follow the directions on your prescription label. Tell your doctor if the medicine seems to stop working as well in relieving your pain.

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

Do not crush, chew, or break a tramadol tablet. Swallow it whole. Breaking the pill may cause too much of the drug to be released at one time. 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.

To take tramadol orally disintegrating tablets (Rybix ODT):

• Keep the tablet in its blister pack until you are ready to take it.

• Using dry hands, remove the tablet and place it in your mouth. It will begin to dissolve right away.

• Do not swallow the tablet whole. Allow it to dissolve in your mouth without chewing.

• Swallow several times as the tablet dissolves. If desired, you may drink liquid to help swallow the dissolved tablet.

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.

Do not stop using tramadol suddenly, or you could have unpleasant withdrawal symptoms. 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 the amount of medicine used from each new bottle. Tramadol is a drug of abuse and you should be aware if anyone is using your medicine improperly or without a prescription.

What happens if I miss a dose?

Take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222. A tramadol overdose can be fatal.

Overdose symptoms may include extreme drowsiness, shallow breathing, muscle weakness, slow heartbeat, cold or clammy skin, fainting, or seizure.

What should I avoid while taking tramadol?

Do not drink alcohol. It may cause a dangerous decrease in your breathing when used together with this medicine. Tramadol may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be alert.

Tramadol Dosing Information

Usual Adult Tramadol Dose for Pain:

For mild to moderate severe chronic pain not requiring rapid onset of analgesic effect:
Initial dose: 25 mg every morning
Titration: increase in 25 mg increments as separate doses every 3 days to reach 100 mg per day taken as 25 mg 4 times per day. Then the total daily dose may be increased by 50 mg as tolerated every 3 days to reach 200 mg per day taken as 50 mg 4 times per day.
Maintenance: After titration, tramadol 50 mg to 100 mg can be administered as needed for pain relief every 4 to 6 hours not to exceed 400 mg per day.

For the management of moderate to moderately severe chronic pain in adults who require around-the-clock treatment of their pain for an extended period of time:
Extended-Release Tablets:
Initial Dose: 100 mg once daily and titrated up as necessary by 100 mg increments every five days to relief of pain and depending upon tolerability.
Maximum Dose: Extended-release tablets should not be administered at a dose exceeding 300 mg per day.

For patients in whom rapid onset of analgesic effect is required and for whom the benefits outweigh the risk of discontinuation due to adverse events associated with higher initial dose:
Dose: 50 mg to 100 mg can be administered as needed for pain relief every 4 to 6 hours, not to exceed 400 mg per day.

Usual Geriatric Tramadol Dose for Pain:

For patients over 65 years:
Dose selection should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function and of concomitant disease or other drug therapy.

For patients over 75 years:
Maximum dose of regular oral tablets: 300 mg per day in divided doses

Usual Pediatric Tramadol Dose for Pain:

16 years old and up:
Brand name: Ryzolt
Initial: 100 mg once daily
Titrate by 100 mg increments every 2 to 3 days if needed for pain control
Maximum: 300 mg/day

Tramadol (Ultram, Tramal, others below) is a centrally-acting analgesic, used in treating moderate to moderately severe pain. The drug has a wide range of applications, including treatment for restless leg syndrome, acid reflux, and fibromyalgia. It was developed by the pharmaceutical company Grünenthal GmbH in the late 1970s

In May 2009, the United States Food and Drug Administration issued a Warning Letter to Johnson & Johnson, alleging that a promotional website commissioned by the manufacturer had "overstated the efficacy" of the drug, and "minimized the serious risks". The company which produced it, the German pharmaceutical company Grünenthal GmbH, were the ones alleged to be guilty of "minimizing" the addictive nature and proposed efficacy of the drug, although it showed little abuse liability in preliminary tests. The 2010 Physicians Desk Reference contains several warnings from the manufacturer, which were not present in prior years. The warnings include more compelling language regarding the addictive potential of tramadol, the possibility of difficulty breathing while on the medication, a new list of more serious side effects, and a notice that tramadol is not to be used in place of opiate medications for addicts. Tramadol is also not to be used in efforts to wean addict patients from opiate drugs, nor to be used to manage long-term opiate addiction.

Side Effects of Tramadol - for the Consumer

Tramadol/Acetaminophen

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome when using Tramadol/Acetaminophen:

Constipation; diarrhea; dizziness; drowsiness; increased sweating; loss of appetite; nausea.

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); severe seizures (convulsions).

Tramadol

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome when using Tramadol:

Constipation; diarrhea; dizziness; drowsiness; dry mouth; headache; nausea; trouble sleeping; vomiting; weakness.

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); agitation; chest pain; difficult or painful urination; disorientation; fainting; hallucinations; irregular heartbeat; loss of coordination; mood or mental changes (eg, depression); red, blistered, swollen, or peeling skin; seizures; severe dizziness or lightheadedness.

Tramadol Extended-Release Tablets

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome when using Tramadol Extended-Release Tablets:

Constipation; diarrhea; dizziness; drowsiness; dry mouth; headache; increased sweating; nausea; trouble sleeping; vomiting; weakness.

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue; unusual hoarseness); agitation; chest pain; difficult or painful urination; disorientation; fainting; hallucinations; irregular heartbeat; loss of coordination; mood or mental changes (eg, depression); red, blistered, swollen, or peeling skin; seizures; severe dizziness or lightheadedness.

The maximum dosage for tramadol in any form is 400 mg per day. Certain manufacturers or formulations have lower maximum doses. For example, Ultracet (37.5 mg/325 mg tramadol/APAP tablets) is capped at 8 tablets per day (300 mg/day). Ultram ER is available in 100, 200, and 300 mg/day doses and is explicitly capped at 300 mg/day as well. Patients taking SSRIs (Prozac, Zoloft, etc.), SNRIs (Efexor, etc.), TCAs, MAOIs, or other strong opioids (oxycodone, methadone, fentanyl, morphine), as well as the elderly (> 75 years old), pediatric (< 18 years old), and those with severely reduced renal (kidney) or hepatic (liver) function should consult their doctor regarding adjusted dosing or whether to use Tramadol at all.

What other drugs will affect tramadol?

You may be more likely to have a seizure (convulsions) if you take tramadol while you are using certain other medicines. Do not take tramadol without telling your doctor if you also use any of the following medications:

• an MAO inhibitor such as isocarboxazid (Marplan), tranylcypromine (Parnate), phenelzine (Nardil), or selegiline (Eldepryl, Emsam); or

• an antidepressant such as amitriptyline (Elavil, Vanatrip), citalopram (Celexa), clomipramine (Anafranil), desipramine (Norpramin), escitalopram (Lexapro), fluoxetine (Prozac, Sarafem), fluvoxamine (Luvox), imipramine (Tofranil), nortriptyline (Pamelor), paroxetine (Paxil), or sertraline (Zoloft).

Tell your doctor about all other medicines you use, especially:

• carbamazepine (Carbatrol, Equetro, Tegretol);

• lithium (Eskalith, LithoBid);

• ADHD medications (Adderall, Ritalin, Strattera);

• an antibiotic such as clarithromycin (Biaxin), erythromycin (E.E.S., EryPed, Ery-Tab, Erythrocin, Pediazole), linezolid (Zyvox), rifampin (Rifadin, Rimactane, Rifater); or telithromycin (Ketek);

• antifungal medication such as clotrimazole (Mycelex Troche), itraconazole (Sporanox), ketoconazole (Nizoral), miconazole (Oravig), or voriconazole (Vfend);

• cancer medications such as gefitinib (Iressa), imatinib (Gleevec), or nilotinib (Tasigna);

• a heart rhythm medication such as amiodarone (Cordarone, Pacerone), flecainide (Tambocor), propafenone (Rythmol), or quinidine (Quin-G);

• heart or blood pressure medication such as diltiazem (Cartia, Cardizem), felodipine (Plendil), nifedipine (Nifedical, Procardia), verapamil (Calan, Covera, Isoptin, Verelan), and others;

• HIV/AIDS medicine such as atazanavir (Reyataz), delavirdine (Rescriptor), fosamprenavir (Lexiva), indinavir (Crixivan), nelfinavir (Viracept), saquinavir (Invirase), or ritonavir (Norvir, Kaletra); or

• migraine headache medicine such as sumatriptan (Imitrex, Treximet).

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