Zydol SR

Tramadol is a prescription medication used to treat moderate to moderately severe pain in adults. Tramadol belongs to a group of drugs called opioid analgesics, which work by blocking pain signals in the body.

This medication comes in immediate release tablet and that can be taken up to 6 times a day, with or without food. Tramadol also comes in extended-release tablet and capsule forms and are taken once a day, with or without food. Do not chew, divide, or break tramadol extended-release forms. Swallow them whole.

Common side effects of tramadol include nausea, constipation, dry mouth, and fatigue. Tramadol can also cause dizziness or drowsiness. Do not drive or operate heavy machinery until you know how tramadol affects you.

Tramadol is a prescription medication used to treat moderate to moderately severe pain.

This medication may be prescribed for other uses. Ask your doctor or pharmacist for more information.

Serious side effects have been reported with tramadol. See "Drug Precautions" section.

Common side effects of tramadol include:

• dizziness
• nausea
• constipation
• drowsiness
• vomiting
• itching skin
• nervousness, agitation, or general change of mood
• uncontrollable shaking of a part of the body
• muscle tightness
• heartburn or indigestion
• dry mouth

This is not a complete list of tramadol side effects. Ask your doctor or pharmacist for more information.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Tell your doctor about all the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements. Especially tell your doctor if you take:

• digoxin (Lanoxin)
• warfarin (Coumadin, Jantoven)
• central nervous system depressants such as alcohol, tranquilizers, or sedative hypnotics
• other opioid medications such as hydrocodone (Vicodin) or oxycodone (Oxycontin)
• medications that block the enzyme CYP3A4 such as some macrolide antibiotics (clarithromycin, telithromycin), some HIV protease inhibitors (indinavir, nelfinavir, ritonavir, saquinavir), some HCV protease inhibitors (boceprevir, telaprevir), some azole antifungals (ketoconazole, itraconazole, posaconazole, voriconazole), conivaptan (Vaprisol), delavirdine (Rescriptor), and nefazodone (Serzone)
• medications that increase the activity of the enzyme CYP3A4 such as carbamazepine (Tegretol, Equetro, Carbatrol), phenobarbital, phenytoin (Dilantin), rifampin, St John's wort, and nimodipine (Nimotop)
• medications that block the enzyme CYP2D6 such as quinidine (Qualaquin), fluoxetine (Prozac, Sarafem), amitriptyline (Elavil, Amitril, Amitid), and paroxetine (Paxil)
• triptans such as sumatriptan (Imitrex, Treximet), eletriptan (Relpax), almotriptan (Axert), frovatriptan (Frova), naratriptan (Amerge), rizatriptan (Maxalt), and zolmitriptan (Zomig)
• monoamine oxidase inhibitors such as tranylcypromine (Parnate), phenelzine (Nardil), selegiline (Eldepryl, Zelapar), isocarboxazid (Marplan), and rasagiline (Azilect)
• selective serotonin reuptake inhibitors (SSRIs) such as escitalopram (Lexapro), sertraline (Zoloft), citalopram (Celexa), vilazodone (Viibryd), paroxetine (Paxil), fluoxetine (Prozac, Sarafem, Symbyax), and fluvoxamine (Luvox)
• tricyclic antidepressants such as trimipramine (Surmontil), amitriptyline (Elavil), nortriptyline (Pamelor, Aventyl), protriptyline (Vivactil), and clomipramine (Anafranil)
• other tricyclic compounds such as cyclobenzaprine (Flexeril) and promethazine (Phenergan)

This is not a complete list of tramadol drug interactions.  Ask your doctor or pharmacist for more information.

Serious side effects have been reported with tramadol including the following:

• seizures. Tell your healthcare provider right away if you have some or all of the following symptoms of seizures:
  • body convulsions (shaking and trembling)
  • temporary loss of consciousness
• serotonin syndrome. Tell your healthcare provider right away if you have some or all of the following symptoms of serotonin syndrome:
  • hallucinations
  • fast heart rate
  • overactive reflexes
  • high blood pressure
  • restlessness or agitation
  • nausea or vomiting
  • decline in muscle coordination
  • rise in body temperature
• discontinuation symptoms. Do not stop tramadol without first talking to your healthcare provider. Stopping tramadol suddenly may cause serious symptoms including the following:
  • anxiety
  • sweating
  • insomnia
  • shaking or shivering
  • pain
  • nausea
  • diarrhea
  • upper airway symptoms
  • goose bumps
  • rarely hallucinations

Tramadol can cause dizziness or drowsiness. Do not drive or operate heavy machinery until you know how tramadol affects you.

Do not take tramadol if you:

• are allergic to tramadol or any of its ingredients

• have a history of respiratory depression in unmonitored settings or the absence of corrective measures
• have a history of acute or chronic bronchial asthma or hypercapnia in unmonitored settings or the absence of corrective measures

Medicines can interact with certain foods. In some cases, this may be harmful and your doctor may advise you to avoid certain foods. In the case of tramadol, there are no specific foods that you must exclude from your diet when receiving tramadol.

Before taking tramadol, tell your doctor about all of your medical conditions. Especially tell your doctor if you:

• are allergic to tramadol or to any of its ingredients
• have respiratory problems
• have a history of seizures or are at risk of seizures
• have medical problems with your digestive tract
• have or have had depression
• have a history of substance or alcohol abuse
• are consuming large amounts of alcohol
• have liver problems
• have kidney problems
• are pregnant or breastfeeding

Tell your doctor about all the medicines you take including prescription and non-prescription medicines,

Tell your doctor if you are pregnant or plan to become pregnant.

The FDA categorizes medications based on safety for use during pregnancy. Five categories - A, B, C, D, and X, are used to classify the possible risks to an unborn baby when a medication is taken during pregnancy.

Tramadol falls into category C. In animal studies, pregnant animals were given this medication and had some babies born with problems. No well-controlled studies have been done in humans. Therefore, this medication may be used if the potential benefits to the mother outweigh the potential risks to the unborn child.

Tell your doctor if you are breastfeeding or plan to breastfeed.

Tramadol has been detected in human breast milk. Because of the possibility for adverse reactions in nursing infants from tramadol, a choice should be made whether to stop nursing or to stop use of this medication. The importance of the drug to the mother should be considered.

Take tramadol exactly as prescribed.

This medication comes in immediate release tablet and can be taken up to 6 times a day, with or without food.

Tramadol also comes in extended-release tablet and capsule form and are taken once a day, with or without food.

Do not chew, divide, or break tramadol extended-release tablets and capsules.

If you miss a dose, take the missed dose as soon as you remember. If it is almost time for the next dose, skip the missed dose and take your next dose at the regular time. Do not take two doses of tramadol at the same time.

Take tramadol exactly as prescribed by your doctor. Follow the directions on your prescription label carefully.

The tramadol dose your doctor recommends will be based on the following:

• the severity of your pain
• other medical conditions you have
• other medications you are taking
• how you respond to this medication
• your age

The recommended dose range of tramadol immediate release tablets is 50 to 100 mg every 4 to 6 hours as needed. Do not take more than 400 mg in a 24-hour period.

The recommended dose range of tramadol extended-release tablets and capsules is 100 to 300 mg once every day.

If you take too much tramadol, call your healthcare provider or local Poison Control Center, or seek emergency medical attention right away.

If tramadol is administered by a healthcare provider in a medical setting, it is unlikely that an overdose will occur. However, if overdose is suspected, seek emergency medical attention.

• Store tramadol between 59°F to 86°F (15°C to 30°C).
• Keep tramadol and all medicines out of the reach of children.