Tramadol

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

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.

Tramadol is used to relieve moderate to moderately severe pain, including pain after surgery. The extended-release or long-acting tablets are used for chronic ongoing pain.

Tramadol belongs to the group of medicines called opioid analgesics. It acts in the central nervous system (CNS) to relieve pain. When tramadol is used for a long time, it may become habit-forming (causing mental or physical dependence). Physical dependence may lead to side effects when you stop taking the medicine.

tramadol is available only with your doctor's prescription.

Take tramadol only as directed by your doctor. Do not take more of it, do not take it more often, and do not take it for a longer time than your doctor ordered.

tramadol should come with a Medication Guide. Read and follow the instructions carefully. Ask your doctor if you have any questions.

If you think that tramadol is not working as well after you have been taking it for a few weeks, do not increase the dose. Instead, check with your doctor.

If you are using the disintegrating tablet, make sure your hands are dry before you handle the tablet. Do not open the blister pack that contains the tablet until you are ready to take it. Remove the tablet from the blister pack by peeling back the foil, then taking the tablet out. Do not push the tablet through the foil. Do not break, crush, or chew it. Place the tablet in your mouth. It should melt quickly. After the tablet has melted, swallow or take a sip of water.

Swallow the extended-release tablet and tabletwhole with liquids. Do not break, crush, or chew it.

Dosing

The dose of tramadol will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of tramadol. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

• For chronic pain:
  • For oral dosage form (extended-release tablets):
    • Adults—At first, 100 milligrams (mg) once a day. Your doctor may increase your dose as needed. However, the dose is usually not more than 300 mg per day.
    • Children—Use and dose must be determined by your doctor.
• For moderate to severe pain:
  • For oral dosage form (disintegrating tablets):
    • Adults and children 16 years of age and older—At first, 50 to 100 milligrams (mg) every four to six hours as needed. Your doctor may increase your dose as needed. However, the dose is usually not more than 400 mg per day.
    • Children younger than 16 years of age—Use and dose must be determined by your doctor.
  • For oral dosage form (tablets):
    • Adults and children 16 years of age and older—At first, 25 milligrams (mg) per day, taken every morning. Your doctor may increase your dose as needed. However, the dose is usually not more than 400 mg per day.
    • Children younger than 16 years of age—Use and dose must be determined by your doctor.

Missed Dose

If you miss a dose of tramadol, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

• Ryzolt
• Tramadol HCl
• Tramadol Hydrochloride

Immediate release: Within 1 hour; Peak effect: 2 to 3 hours

Time to Peak

Immediate release: ~2 hours; active metabolite (M1): 3 hours

Extended release: ~4 to 12 hours; active metabolite (M1): ~5 to 15 hours

Half-Life Elimination

Immediate release: 6.3 ± 1.4 hours; active metabolite (M1): 7.4 ± 1.4 hours; prolonged in elderly

Extended release:

Capsules: ~10 hours; active metabolite (M1): ~11 hours

Tablets: ~7.9 hours; active metabolite (M1): 8.8 hours

Protein Binding

Plasma: ~20%

Immediate release: Metabolism is reduced in advanced cirrhosis, resulting in increased AUC and increased elimination half-life (13 hours [tramadol], 19 hours [M1]).

Extended release: Exposure is decreased ~50% with increased severity of hepatic impairment.

Hypersensitivity (eg, anaphylaxis) to tramadol, opioids, or any component of the formulation; significant respiratory depression; acute or severe bronchial asthma in the absence of appropriately monitored settings and/or resuscitative equipment; GI obstruction, including paralytic ileus (known or suspected); concomitant use with or within 14 days following MAO inhibitor therapy

Canadian products: Additional contraindications (not in US labeling): (Note: Contraindications may differ between product labeling; refer also to product labeling): Severe renal impairment (CrCl <30 mL/minute), severe hepatic impairment (Child-Pugh class C); mild, intermittent or short-duration pain that can be managed with other pain medication; management of perioperative pain; status asthmaticus, chronic obstructive airway, acute respiratory depression, hypercapnia, cor pulmonale, delirium tremens, seizure disorder, severe CNS depression, increased cerebrospinal or intracranial pressure, head injury, suspected surgical abdomen (eg, acute appendicitis or pancreatitis); acute intoxication with ethanol, hypnotics, centrally acting analgesics, opioids, or psychotropic drugs; breastfeeding, pregnancy; use during labor and delivery

Moderate to severe pain: Oral:

Immediate release: Adolescents ≥17 years: Refer to adult dosing.

Extended release: Adolescents ≥18 years: Refer to adult dosing.

Tramadol exposes patients and other users to the risks of opioid addiction, abuse, and misuse, which can lead to overdose and death. Assess each patient’s risk prior to prescribing tramadol, and monitor all patients regularly for the development of these behaviors and conditions.

Serious, life-threatening, or fatal respiratory depression may occur with use of tramadol. Monitor for respiratory depression, especially during initiation of tramadol or following a dose increase. Instruct patients to swallow tramadol capsules and tablets intact, and not to split, break, chew, crush, or dissolve the contents of the capsules or tablets to avoid exposure to a potentially fatal dose of tramadol.

Accidental ingestion of even one dose of tramadol, especially by children, can result in a fatal overdose of tramadol.

Prolonged use of tramadol during pregnancy can result in neonatal opioid withdrawal syndrome, which may be life-threatening if not recognized and treated, and requires management according to protocols developed by neonatology experts. If opioid use is required for a prolonged period in a pregnant woman, advise the patient of the risk of neonatal opioid withdrawal syndrome and ensure that appropriate treatment will be available.

The effects of concomitant use or discontinuation of cytochrome P450 3A4 inducers, 3A4 inhibitors, or 2D6 inhibitors with tramadol are complex. Use of cytochrome P450 3A4 inducers, 3A4 inhibitors, or 2D6 inhibitors with tramadol requires careful consideration of the effects on the parent drug, tramadol, and the active metabolite, M1.

Concomitant use of opioids with benzodiazepines or other CNS depressants, including alcohol, may result in profound sedation, respiratory depression, coma, and death. Reserve concomitant prescribing of tramadol and benzodiazepines or other CNS depressants for use in patients for whom alternative treatment options are inadequate. Limit dosages and durations to the minimum required. Follow patients for signs and symptoms of respiratory depression and sedation.