Tramadol is a pain medication typically prescribed to patients in moderate to severe pain who will need pain medication for an extended period of time, why isn"t tramadol a controlled substance. An opiate agonist, this medicine alters the way the body feels pain. This medicine comes immediate and extended release form, but it's also available in other forms.
Drug Uses
Patients over 17 years of age with chronic pain that is moderate to severe may be prescribed Tramadol. It is used to treat pain resulting from any disorder causing stiff or painful muscles, or neuropathic pain. This medication works best when taken at the first sign of pain, why isn"t tramadol a controlled substance, and may not be as effective if you wait until the pain has worsened.
Available Doses
The dose prescribed varies depending on the condition for which this drug is prescribed. The maximum recommended dose of Tramadol is 400 milligrams a day, why isn"t tramadol a controlled substance. For patients on dialysis, the maximum recommended dose is 100 milligrams every 12 hours, why isn"t tramadol a controlled substance. For patients with liver disease or cirrhosis, the maximum recommended dose is 50 milligrams every 12 hours. Patients over 75 years of age should not take more than 300 milligrams a day. Precautions and Risks
Inform your doctor of any allergies you have before starting this medicine. You should not take Tramadol if you have severe breathing problems or take medicine that depresses the nervous system such as sedatives. Tell your doctor if you have a history of certain bowel diseases, urinary problems, brain disorders, , kidney disease, liver disease, , lung disease, why isn"t tramadol a controlled substance, or intestinal problems. This drug may make you drowsy, so don't drive until you know how it will affect you. Tramadol is not recommended for use in pregnant women and the drug passes into breast milk. For patients who have used this drug for a long time, withdrawal may occur upon ending use of this drug, why isn"t tramadol a controlled substance, especially if the dose was high. Symptoms of withdrawal may be anxiety, sleeplessness, rapid breathing, or sweating. This medicine should not be used in patients with a history of drug or alcohol abuse, as this drug is highly addictive. Side Effects
Common side effects are nausea, vomiting, constipation, , dizziness, headache, , or drowsiness, why isn"t tramadol a controlled substance. Many Tramadol users will never experience any side effects as a result of this medication. Rare but severe side effects include extreme muscle stiffness, severe abdominal pain, vision changes, or seizures. If you experience any of these symptoms, contact your doctor immediately. An allergic reaction to this drug is possible, but rare, . If you notice a rash, itching or swelling, or trouble breathing after taking Tramadol, seek medical attention. A rare but serious condition called serotonin syndrome could result from use of Tramadol. Seek medical attention if you experience mental changes, , restlessness, why isn"t tramadol a controlled substance, fast heartbeat, , severe dizziness, severe nausea or vomiting, , or muscle twitches. Drug Interactions
Tramadol should not be taken with MAO inhibitors. Tell your doctor if you're taking medicine to treat nausea or drugs that cause an increase in serotonin, such as St, why isn"t tramadol a controlled substance. John's Wort, Lithium, why isn"t tramadol a controlled substance, SSRIs, or medications used to treat migraine headaches. Some medications may affect the way this drug is absorbed into your body, , so tell your doctor if you're taking medications like antibiotics or drugs used to treat seizures, why isn"t tramadol a controlled substance. Drowsiness may be increased if combined with antihistamines, , anti-anxiety drugs, sleep medications, or muscle relaxants. Overdose
Tramadol should be taken only at the dose prescribed by your doctor. Symptoms of overdose are shallow breathing, why isn"t tramadol a controlled substance, irregular heartbeat, , loss of consciousness, or heart attack. If you experience any of these symptoms, call a poison control center or emergency room immediately, . Disclaimer
This drug information is not intended to cover all uses, instructions, interactions, precautions, or adverse effects of this medication. It is for general informational purposes only and should not replace the advice of a medical doctor. Specific patients and conditions require specific instructions, and this information should be given by the prescribing doctor, . We disclaim all responsibility for the accuracy and reliability of this information, why isn"t tramadol a controlled substance, and any consequences resulting from the use of this information, including damages or adverse consequences to persons or property. No warranty, either expressed or implied, is made in regards to this information, .
Tramadol Precautions Respiratory Depression When large doses of Ultram are administered with anesthetic medications or alcohol, respiratory depression may result. Cases of intraoperative respiratory depression, usually with large intravenous doses of tramadol and with concurrent administration of respiratory depressants, have been reported in foreign experience. Such cases should be treated as overdoses (see OVERDOSAGE). Ultram should be administered cautiously in patients at risk for respiratory depression. Increased Intracranial Pressure or Head Trauma Ultram should be used with caution in patients with increased intracranial pressure or head injury. Pupillary changes (miosis) from tramadol may obscure the existence, extent or course of intracranial pathology. Clinicians should also maintain a high index of suspicion for adverse drug reaction when evaluating mental status in these patients if they are receiving Ultram. Acute Abdominal Conditions The administration of Ultram may complicate the clinical assessment of patients with acute abdominal conditions, . Patients Physically Dependent on Opioids Ultram is not recommended for patients who are dependent on opioids, why isn"t tramadol a controlled substance. Patients who have recently taken substantial amounts of opioids may experience withdrawal symptoms. Because of the difficulty in assessing dependence in patients who have previously received substantial amounts of opioid medication, caution should be used in the administration of Ultram to such patients. Use in Renal and Hepatic Disease Impaired renal function results in a decreased rate and extent of excretion of tramadol and its active metabolite M1. In patients with creatinine clearances of less than 30 ml/min dosing reduction is recommended (see DOSAGE AND ADMINISTRATION). Metabolism of tramadol and M1 is reduced in patients with advanced cirrhosis of the liver. In cirrhotic patients, dosing reduction is recommended (see DOSAGE AND ADMINISTRATION). With the prolonged half-life in these conditions, achievement of steady state is delayed, so that it may take several days for elevated plasma concentrations to develop. Information for Patients Patients being treated with Ultram should receive the following information: Ultram may impair mental or physical abilities required for the performance of potentially hazardous tasks such as driving a car or operating machinery. Carcinogenesis, why isn"t tramadol a controlled substance, Mutagenesis, Impairment of Fertility Tramadol was not mutagenic in the following assays: Ames Salmonella microsomal activation test, CHO/HPRT mammalian cell assay, why isn"t tramadol a controlled substance, mouse lymphoma assay (in the absence of metabolic activation), , dominant lethal mutation tests in mice, why isn"t tramadol a controlled substance, chromosome aberration test in Chinese hamsters, and bone marrow micronucleus tests in mice and Chinese hamsters. Weakly mutagenic results occurred in the presence of metabolic activation in the mouse lymphoma assay and micronucleus test in rats. Overall, the weight of evidence from these tests indicates that tramadol does not pose a genotoxic risk to humans. A slight, but statistically significant, increase in two common murine tumors, pulmonary and hepatic, was observed in a mouse carcinogenicity study, particularly in aged mice (dosing orally up to 30 mg/kg for approximately two years, although the study was not done with the Maximum Tolerated Dose), why isn"t tramadol a controlled substance. This finding is not believed to suggest risk in humans. No such finding occurred in a rate carcinogenicity study. No effects on fertility were observed for tramadol at oral dose levels up to 50 mg/kg in male rats and 75 mg/kg in female rats, . Teratogenic Effects: Usage in Pregnancy Pregnancy Category C There are no adequate and well-controlled studies in pregnant women. Ultram should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Tramadol has been shown to be embryotoxic and fetotoxic in mice, rats and rabbits and maternally toxic doses 3 to 15 times the maximum human dose or higher (120 mg/kg in mice, why isn"t tramadol a controlled substance, 25 mg/kg or higher in rats and 75 mg/kg or higher in rabbits), , but was not teratogenic at these dose levels. No harm to the fetus due to tramadol was seen at doses that were not maternally toxic. No drug-related teratogenic effects were observed in progeny of mice, rats or rabbits treated with tramadol by various routes (up to 140 mg/kg for mice, 80 mg/kg for rats or 300 mg/kg for rabbits). Embryo and fetal toxicity consisted primarily of decreased fetal weights, skeletal ossification and increased supemumerary ribs at maternally toxic dose levels. Transient delays in developmental or behavioral parameters were also seen in pups in rat dams allowed to deliver. Embryo and fetal lethality were reported only in one rabbit study at 300 mg/kg, a dose that would cause extreme maternal toxicity in the rabbit, . In peri- and post-natal studies in rats, progeny of dams receiving oral (gavage) dose levels of 50 mg/kg or greater had decreased weights, and pup survival was decreased early in lactation at 80 mg/kg (6 to 10 times the maximum human dose), why isn"t tramadol a controlled substance. No toxicity was observed for progeny of dams receiving 8, 10, 20, 25 or 40 mg/kg. Maternal toxicity was observed at all dose levels, but effects on progeny were evident only at higher dose levels where maternal toxicity was more severe. Labor and Delivery Ultram should not be used in pregnant women prior to or during labor unless the potential benefits outweigh the risks, because safe use in pregnancy has not been established. Tramadol has been shown to cross the placenta. The mean ratio of serum tramadol in the umbilical veins compared to maternal veins was for 40 women given tramadol during labor. The effect of Ultram, , if any, on the later growth, , development, and functional maturation of the child is unknown. Nursing Mothers Ultram is not recommended for obstetrical preoperative medication or for post-delivery analgesia in nursing mothers because its safety in infants and newborns has not been studied. Following a single 100 mg dose of tramadol, the cumulative excretion in breast milk within 16 hours postdose was 100 µg of tramadol (0.1% of the maternal dose) and 27 µg of M1, why isn"t tramadol a controlled substance. Pediatric Use The pediatric use of Ultram (tramadol hydrochloride) is not recommended because safety and efficacy in patients under 16 years of age have not been established. Use in the Elderly In subjects over the age of 75 years, serum concentrations are slightly elevated and the elimination half-life is slightly elevated and the elimination half-life is slightly prolonged. The aged also can be expected to vary more widely in their ability to tolerate adverse drug effects. Daily doses in excess of 300 mg are not recommended in patients over 75 
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