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What is tramadol?

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.

DRUG CLASS AND MECHANISM: Tramadol is a man-made (synthetic) analgesic (pain reliever). Its exact mechanism of action is unknown but similar morphine. Like morphine, tramadol binds to receptors in the brain (opioid receptors) that are important for transmitting the sensation of pain from throughout the body to. Tramadol, like other narcotics used for the treatment of pain, may be abused. Tramadol is not a nonsteroidal antiinflammatory drug (NSAID) and does not have the increased risk of stomach ulceration and internal bleeding that can occur with NSAIDs.

PRESCRIBED FOR: Tramadol is used in the management of moderate to moderately severe pain. Extended release tablets are used for moderate to moderately severe chronic pain in adults who require continuous treatment for an extended period.

DOSING: The recommended dose of tramadol is 50-100 mg (immediate release tablets) every 4-6 hours as needed for pain. The maximum dose is 400 mg/day. To improve tolerance patients should be started at 25 mg/day, and doses may be increased by 25 mg every 3 days to reach 100 mg/day (25 mg 4 times daily). Thereafter, doses can be increased by 50 mg every 3 days to reach 200 mg day (50 mg 4 times daily). Tramadol may be taken with or without food.

Recommended dose for extended release tablets is 100 mg daily which may be increased by 100 mg every 5 days but not to exceed 300 mg /day. Extended release tablets should be swallowed whole and not crushed or chewed.

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 side effects

Get emergency medical help if you have any of these signs of an allergic reaction: 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:

• seizure (convulsions);
• a red, blistering, peeling skin rash; or
• shallow breathing, weak pulse.

Less serious side effects may include:

• dizziness, drowsiness, weakness;
• nausea, vomiting, constipation, loss of appetite;
• blurred vision;
• flushing (redness, warmth, or tingly feeling); or
• sleep problems (insomnia).

This is not a complete list of side effects and others may occur. Tell your doctor about any unusual or bothersome side effect. You may report side effects to FDA at 1-800-FDA-1088.

Pharmacodynamics

ULTRAM® contains tramadol, a centrally acting synthetic opioid analgesic. Although its mode of action is not completely understood, from animal tests, at least two complementary mechanisms appear applicable: binding of parent and M1 metabolite to ?-opioid receptors and weak inhibition of reuptake of norepinephrine and serotonin.

Opioid activity is due to both low affinity binding of the parent compound and higher affinity binding of the O-demethylated metabolite M1 to ?-opioid receptors. In animal models, M1 is up to 6 times more potent than tramadol in producing analgesia and 200 times more potent in ?-opioid binding. Tramadol-induced analgesia is only partially antagonized by the opiate antagonist naloxone in several animal tests. The relative contribution of both tramadol and M1 to human analgesia is dependent upon the plasma concentrations of each compound (see CLINICAL PHARMACOLOGY, Pharmacokinetics).

Tramadol has been shown to inhibit reuptake of norepinephrine and serotonin in vitro, as have some other opioid analgesics. These mechanisms may contribute independently to the overall analgesic profile of ULTRAM®. Analgesia in humans begins approximately within one hour after administration and reaches a peak in approximately two to three hours.

Apart from analgesia, ULTRAM® administration may produce a constellation of symptoms (including dizziness, somnolence, nausea, constipation, sweating and pruritus) similar to that of other opioids. In contrast to morphine, tramadol has not been shown to cause histamine release. At therapeutic doses, ULTRAM® has no effect on heart rate, left-ventricular function or cardiac index. Orthostatic hypotension has been observed.

Absorption

The mean absolute bioavailability of a 100 mg oral dose is approximately 75%. The mean peak plasma concentration of racemic tramadol and M1 occurs at two and three hours, respectively, after administration in healthy adults. In general, both enantiomers of tramadol and M1 follow a parallel time course in the body following single and multiple doses although small differences (~10%) exist in the absolute amount of each enantiomer present.

Steady-state plasma concentrations of both tramadol and M1 are achieved within two days with four times per day dosing. There is no evidence of self-induction (see Figure 1 and Table 1 below).

Figure 1: Mean Tramadol and M1 Plasma Concentration Profiles after a Single 100 mg Oral Dose and after Twenty-Nine 100 mg Oral Doses of Tramadol HCl given four times per day

 

 

Table 1 Mean (%CV) Pharmacokinetic Parameters for Racemic Tramadol and M1 Metabolite

  

Population/Dosage Regimena	Parent Drug/ Metabolite	Peak Conc.(ng/mL)	Time to Peak (hrs)	Clearance/ Fb (mL/min/Kg)	t½ (hrs)
Healthy Adults,100 mg qid, MD p.o.	Tramadol	592 (30)	2.3 (61)	5.90 (25)	6.7 (15)
	M1	110 (29)	2.4 (46)	c	7.0 (14)
Healthy Adults,100 mg SD p.o.	Tramadol	308 (25)	1.6 (63)	8.50 (31)	5.6 (20)
	M1	55.0 (36)	3.0 (51)	c	6.7 (16)
Geriatric, ( > 75 yrs) 50 mg SD p.o.	Tramadol	208 (31)	2.1 (19)	6.89 (25)	7.0 (23)
	M1	d	d	c	d
Hepatic Impaired, 50 mg SD p.o.	Tramadol	217 (11)	1.9 (16)	4.23 (56)	13.3 (11)
	M1	19.4 (12)	9.8 (20)	c	18.5 (15)
Renal Impaired, CLcr10-30 mL/min 100 mg SD i.v.	Tramadol	c	c	4.23 (54)	10.6 (31)
	M1	c	c	c	11.5 (40)
Renal Impaired, CLcr < 5 mL/min 100 mg SD i.v.	Tramadol	c	c	3.73 (17)	11.0 (29)
	M1	c	c	c	16.9 (18)
a SD = Single dose, MD = Multiple dose, p.o.= Oral administration, i.v.= Intravenous administration, q.i.d. = Four times daily b F represents the oral bioavailability of tramadol c Not applicable d Not measured

 

Food Effects

Oral administration of ULTRAM® with food does not significantly affect its rate or extent of absorption, therefore, ULTRAM® can be administered without regard to food.

Distribution

The volume of distribution of tramadol was 2.6 and 2.9 liters/kg in male and female subjects, respectively, following a 100 mg intravenous dose. The binding of tramadol to human plasma proteins is approximately 20% and binding also appears to be independent of concentration up to 10 ?g/mL. Saturation of plasma protein binding occurs only at concentrations outside the clinically relevant range.

Metabolism

Tramadol is extensively metabolized after oral administration by a number of pathways, including CYP2D6 and CYP3A4, as well as by conjugation of parent and metabolites. Approximately 30% of the dose is excreted in the urine as unchanged drug, whereas 60% of the dose is excreted as metabolites. The remainder is excreted either as unidentified or as unextractable metabolites. The major metabolic pathways appear to be N- and O-demethylation and glucuronidation or sulfation in the liver. One metabolite (O-desmethyltramadol, denoted M1) is pharmacologically active in animal models. Formation of M1 is dependent on CYP2D6 and as such is subject to inhibition, which may affect the therapeutic response (see PRECAUTIONS: DRUG INTERACTIONS).

Approximately 7% of the population has reduced activity of the CYP2D6 isoenzyme of cytochrome P-450. These individuals are “poor metabolizers” of debrisoquine, dextromethorphan, tricyclic antidepressants, among other drugs. Based on a population PK analysis of Phase I studies in healthy subjects, concentrations of tramadol were approximately 20% higher in “poor metabolizers” versus “extensive metabolizers”, while M1 concentrations were 40% lower. Concomitant therapy with inhibitors of CYP2D6 such as fluoxetine, paroxetine and quinidine could result in significant drug interactions. In vitro drug interaction studies in human liver microsomes indicate that inhibitors of CYP2D6 such as fluoxetine and its metabolite norfluoxetine, amitriptyline and quinidine inhibit the metabolism of tramadol to various degrees, suggesting that concomitant administration of these compounds could result in increases in tramadol concentrations and decreased concentrations of M1. The full pharmacological impact of these alterations in terms of either efficacy or safety is unknown. Concomitant use of SEROTONIN re-uptake INHIBITORS and MAO INHIBITORS may enhance the risk of adverse events, including seizure (see WARNINGS) and serotonin syndrome.