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ALTRAM (tramadol
hydrochloride tablets) is a centrally acting analgesic.
Tramadol hydrochloride is a white, bitter, crystalline and
odorless powder. It is readily soluble in water and
ethanolInactive ingredients in the tablet are corn starch,
hypromellose, lactose, magnesium stearate, microcrystalline
cellulose, polyethylene glycol, polysorbate 80, sodium starch
glycolate, titanium dioxide and wax.
INDICATIONS
ALTRAM is indicated for the management of moderate to moderately
severe pain in adults.
DOSAGE AND ADMINISTRATION
Adults (17 years of age and over)
For patients with moderate to moderately severe chronic pain not
requiring rapid onset of analgesic effect, the tolerability of
ALTRAM can be improved by initiating therapy with the following
titration regimen: ALTRAM should be started at 25 mg/day qAM and
titrated in 25 mg increments as separate doses every 3 days to
reach 100 mg/day (25 mg q.i.d.). Thereafter the total daily dose
may be increased by 50 mg as tolerated every3days to reach 200
mg/day (50 mg q.i.d.). After titration, ALTRAM 50 to 100 mg can be
administered as needed for pain relief every 4 to 6 hours not to
exceed 400 mg/day.
For the subset of patients for whom rapid onset of analgesic
effect is required and for whom the benefits outweigh the risk of
discontinuation due to adverse events associated with higher
initial doses, ALTRAM 50 mg to 100 mg can be administered as
needed for pain relief every four to six hours, not to exceed 400
mg per day.
USES
This medication is used to relieve moderate pain. It is
similar to narcotic pain medications. It works on certain nerves
in the brain that control how you experience pain.
CONTRAINDICATIONS
ALTRAM should not be administered to patients who have previously
demonstrated hypersensitivity to tramadol, any other component of
this product or opioids.ALTRAM is contraindicated in any situation
where opioids are contraindicated, including acute intoxication
with any of the following: alcohol, hypnotics, narcotics,
centrally acting analgesics, opioids or psychotropic drugs. ALTRAM
may worsen central nervous system and respiratory depression in
these patients.
SIDE EFFECTS
Nausea, vomiting, constipation, lightheadedness, dizziness,
drowsiness, headache, or weakness may occur. If any of these
effects persist or worsen, tell your doctor or pharmacist
promptly.
To prevent constipation, maintain a diet adequate in fiber, drink
plenty of water, and exercise. If you are taking tramadol
regularly, it may be useful to start using a laxative right away
instead of waiting until you become constipated. Consult your
pharmacist for details regarding the correct use of laxatives
(e.g., stimulant-type with stool softener).
This medication may rarely cause a very serious condition called
serotonin syndrome. The risk increases when this medication is
used with certain other drugs (see Drug Interactions section).
Seek immediate medical attention if you develop some of the
following symptoms: mental/mood changes (such as agitation,
hallucinations), unusual restlessness, loss of coordination, fast
heartbeat, severe dizziness, unexplained fever, severe
nausea/vomiting/diarrhea, twitchy muscles.
PRECAUTIONS
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.
STORAGE
Store at room temperature at 77 degrees F (25 degrees C) away
from light and moisture. Brief storage between 59-86 degrees F
(15-30 degrees C) is permitted. Do not store in the bathroom.
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