Tramadol is not approved by the FDA for use by children younger than 16 years of age.
ULTRAM® (tramadol hydrochloride) tablets is a centrally acting analgesic. The chemical name for tramadol hydrochloride is (±)cis-2-[(dimethylamino)methyl]-1-(3methoxyphenyl) cyclohexanol hydrochloride. Its structural formula is:
tramadol
The molecular weight of tramadol hydrochloride is 299.8. Tramadol hydrochloride is a white, bitter, crystalline and odorless powder. It is readily soluble in water and ethanol and has a pKa of 9.41. The n-octanol/water log partition coefficient (logP) is 1.35 at pH 7. ULTRAM® tablets contain 50 mg of tramadol hydrochloride and are white in color. Inactive ingredients in the tablet are pregelatinized corn starch, modified starch (corn), hypromellose, lactose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80, sodium starch glycolate, titanium dioxide and carnauba wax.
Tramadol is used to relieve moderate to moderately severe pain. It also may be used to treat pain caused by surgery and chronic conditions such as cancer or joint pain. Tramadol works by decreasing the brain’s perception and response to pain. It also reduces the size or magnitude of the pain signal passed from one nerve to another. This medication is sometimes prescribed for other uses; ask your doctor or pharmacist for more information.
Tramadol PRECAUTIONS:
Before taking tramadol, tell your doctor or pharmacist if you are allergic to it; or to other narcotics (e.g., codeine); or if you have any other allergies.
This medication should not be used if you have certain medical conditions. Before using this medicine, consult your doctor or pharmacist if you have: severe breathing problems (e.g., respiratory depression, hypercapnia), intoxication with drugs that depress the nervous system or your breathing (CNS/respiratory depressants such as alcohol or tranquilizers/sedatives).
Before using this medication, tell your doctor or pharmacist your medical history, especially of: certain bowel diseases (paralytic ileus), brain disorders (e.g., seizures, increased intracranial pressure), conditions that increase the risk of seizures (e.g., head injury, brain tumors, meningitis, metabolic disorders, alcohol/drug withdrawal), adrenal gland problem (e.g., Addison's disease), difficulty urinating (e.g., enlarged prostate, urethral narrowing), heart problems (e.g., irregular heartbeat), personal or family history of regular use/abuse of drugs/alcohol, kidney disease, liver disease, lung diseases (e.g., chronic obstructive pulmonary disease-COPD, hypoxia), disease of the pancreas (e.g., pancreatitis), mental/mood conditions (e.g., major depression, toxic psychosis), a certain spinal problem (kyphoscoliosis), stomach/intestinal problems (e.g., gallbladder disease), underactive thyroid (hypothyroidism).
This drug may make you dizzy or drowsy. Use caution while driving, using machinery, or doing any activity that requires alertness. Avoid alcoholic beverages because they may increase the risk of this drug's side effects.
To reduce dizziness and lightheadedness, get up slowly when rising from a sitting or lying position.
Caution is advised when using this drug in the elderly because they may be more sensitive to its effects, especially slow/shallow breathing and drowsiness.
During pregnancy, this medication should be used only when clearly needed. It is not recommended for use for long periods or in high doses late in pregnancy because of possible serious harm to your baby. Discuss the risks and benefits with your doctor. Infants born to mothers who have been using this medication for an extended time may have seizures or withdrawal symptoms such as irritability, abnormal/persistent crying, or diarrhea. Tell your doctor immediately if you notice any of these symptoms in your newborn.
This drug passes into breast milk. While there have been no reports of harm to nursing infants, consult your doctor before breast-feeding.
