Tramadol 50mg

CYP2D6 and CYP3A4 Inhibitors

Concomitant administration of CYP2D6 and/or CYP3A4 inhibitors, such as quinidine, fluoxetine, paroxetine and amitriptyline (CYP2D6 inhibitors), and ketoconazole and erythromycin (CYP3A4 inhibitors), may reduce metabolic clearance of tramadol increasing the risk for serious adverse events including seizures and serotonin syndrome.

Serotonergic Drugs

There have been postmarketing reports of serotonin syndrome with use of tramadol and SSRIs/SNRIs or MAOIs and α2-adrenergic blockers. Caution is advised when ULTRAM® is coadministered with other drugs that may affect the serotonergic neurotransmitter systems, such as SSRIs, MAOIs, triptans, linezolid (an antibiotic which is a reversible non-selective MAOI), lithium, or St. John’s Wort. If concomitant treatment of ULTRAM® with a drug affecting the serotonergic neurotransmitter system is clinically warranted, careful observation of the patient is advised, particularly during treatment initiation and dose increases.

Triptans

Based on the mechanism of action of tramadol and the potential for serotonin syndrome, caution is advised when ULTRAM® is coadministered with a triptan. If concomitant treatment of ULTRAM® with a triptan is clinically warranted, careful observation of the patient is advised, particularly during treatment initiation and dose increases .

Use With Carbamazepine

Patients taking carbamazepine may have a significantly reduced analgesic effect of ULTRAM®. Because carbamazepine increases tramadol metabolism and because of the seizure risk associated with tramadol, concomitant administration of ULTRAM® and carbamazepine is not recommended.

Use With Quinidine

Tramadol is metabolized to M1 by CYP2D6. Quinidine is a selective inhibitor of that isoenzyme, so that concomitant administration of quinidine and ULTRAM® results in increased concentrations of tramadol and reduced concentrations of M1. The clinical consequences of these findings are unknown. In vitro drug interaction studies in human liver microsomes indicate that tramadol has no effect on quinidine metabolism.

Potential for Other Drugs to Affect Tramadol

In vitro drug interaction studies in human liver microsomes indicate that concomitant administration with inhibitors of CYP2D6 such as fluoxetine, paroxetine, and amitriptyline could result in some inhibition of the metabolism of tramadol. Administration of CYP3A4 inhibitors, such as ketoconazole and erythromycin, or inducers, such as rifampin and St. John’s Wort, with Ultram® may affect the metabolism of tramadol leading to alteted tramadol exposure.

Potential for Tramadol to Affect Other Drugs

In vitro studies indicate that tramadol is unlikely to inhibit the CYP3A4-mediated metabolism of other drugs when tramadol is administered concomitantly at therapeutic doses. Tramadol does not appear to induce its own metabolism in humans, since observed maximal plasma concentrations after multiple oral doses are higher than expected based on single-dose data. Tramadol is a mild inducer of selected drug metabolism pathways measured in animals.

Use With Cimetidine

Concomitant administration of ULTRAM® with cimetidine does not result in clinically significant changes in tramadol pharmacokinetics. Therefore, no alteration of the ULTRAM® dosage regimen is recommended.

Use With Digoxin and Warfarin

Post-marketing surveillance has revealed rare reports of digoxin toxicity and alteration of warfarin effect, including elevation of prothrombin times.

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.

Tramadol side effects

Get emergency medical help if you have any of these signs of an allergic reaction to tramadol: hives; difficulty breathing; swelling of your face, lips, tongue, or throat. Stop using tramadol and call your doctor at once if you have any of these serious side effects:

• agitation, hallucinations, fever, fast heart rate, overactive reflexes, nausea, vomiting, diarrhea, loss of coordination, fainting;
• seizure (convulsions);
• a red, blistering, peeling skin rash; or
• shallow breathing, weak pulse.

Less serious tramadol side effects may include:

• dizziness, spinning sensation;
• constipation, upset stomach;
• headache;
• drowsiness; or
• feeling nervous or anxious.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

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

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).

Cold or allergy medicine, sleeping pills, muscle relaxers, and medicine for seizures or anxiety can add to sleepiness caused by tramadol. Tell your doctor if you regularly use any of these medicines, or any other pain medication.

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).

This list is not complete and there are many other drugs that can interact with tramadol. Tell your doctor about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal products. Do not start a new medication without telling your doctor. Keep a list of all your medicines and show it to any healthcare provider who treats you.