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Ultracet
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Combination medicines
containing opioid analgesics (nar-KOT-ik an-al-JEE-zicks
) such as tramadol (TRA-ma-dole) and acetaminophen
(a-seat-a-MIN-oh-fen ) are used to relieve pain. An
opioid analgesic and acetaminophen used together may
provide better pain relief than either medicine used
alone. In some cases, you may get relief with lower
doses of each medicine.
Description
Combination medicines containing
opioid analgesics (nar-KOT-ik an-al-JEE-zicks ) such as
tramadol (TRA-ma-dole) and acetaminophen
(a-seat-a-MIN-oh-fen ) are used to relieve pain. An
opioid analgesic and acetaminophen used together may
provide better pain relief than either medicine used
alone. In some cases, you may get relief with lower
doses of each medicine.
Opioid analgesics act in the central nervous system
(CNS) to relieve pain. Many of their side effects are
also caused by actions in the CNS. When opioids are used
for a long time, your body may get used to them so that
larger amounts are needed to relieve pain. This is
called tolerance to the medicine. Also, when opioids are
used for a long time or in large doses, they may become
habit-forming (causing mental or physical dependence).
Physical dependence may lead to withdrawal symptoms when
you stop taking the medicine.
Acetaminophen does not become habit-forming when
taken for a long time but it may cause other unwanted
effects, when taken in large doses including liver
damage, if too much is taken.
Ultracet is available only with your doctor's
prescription, in the following dosage form:
Oral
Tablets (U.S.)
Before Using Ultracet
In deciding to use a
medicine, the risks of taking the medicine must be
weighed against the good it will do. This is a decision
you and your doctor will make. For tramadol and
acetaminophen, the following should be considered:
Allergies - Tell your doctor
if you have ever had any unusual or allergic reaction to
tramadol, other opioid analgesics or acetaminophen. Also
tell your health care professional if you are allergic
to any other substances, such as foods, preservatives,
or dyes.
Pregnancy - Tramadol and
acetaminophen has not been studied in pregnant women.
However, studies in animals have shown that tramadol and
acetaminophen causes birth defects and other problems.
Before taking Ultracet, make sure your doctor knows if
you are pregnant or if you may become pregnant.
Too much use of an opioid during pregnancy may cause
the fetus to become dependent on the medicine. This may
lead to withdrawal side effects in the newborn baby.
Newborn seizures, symptoms of withdrawal from opioids,
death of the fetus and still birth have been reported.
Breast-feeding - Tramadol and
acetaminophen pass into breast milk and may cause
unwanted side effects in nursing babies. It may be
necessary for you to take another medicine or to stop
breast-feeding during treatment. Be sure you have
discussed the risks and benefits of the medicine with
your doctor.
Children - Studies on
Ultracet have been done only in adult patients, and
there is no specific information comparing use of
tramadol and acetaminophen in children up to 16 years of
age with use in other age groups.
Older adults - Ultracet has
been tested and has not been shown to cause different
side effects or problems in older people than it does in
younger adults.
Other medicines - Although
certain medicines should not be used together at all, in
other cases two different medicines may be used together
even if an interaction might occur. In these cases, your
doctor may want to change the dose, or other precautions
may be necessary. When you are taking tramadol and
acetaminophen, it is especially important that your
health care professional know if you are taking any of
the following:
- Tramadol and acetaminophen
- Anticoagulants (e.g., Coumadin [blood
thinners])-Tramadol and acetaminophen may increase the
amount of blood thinners in your blood, which can
cause problems with bleeding.
- Alcohol and products with alcohol in them-Taking
these medicines with tramadol and acetaminophen may
cause problems with your liver.
For acetaminophen:
- Acetaminophen-containing products (e.g., Tylenol,
Nyquil, Chlor-Trimeton Sinus)-Taking additional
acetaminophen may increase the risk of liver problems.
For tramadol:
- Analgesics, opioid (e.g., codeine, morphine) or
- Antidepressants such as tricyclic antidepressants
(e.g., amitriptyline [Elavil], doxepin [Sinequan]),
and selective serotonin reuptake inhibitors (e.g.,
citalopram [Celexa], fluvoxamine [Luvox], sertraline
[Zoloft]), and medicines with Monoamine oxidase (MAO)
inhibitor activity (isocarboxazid [e.g., Marplan],
phenelzine [e.g., Nardil], procarbazine [e.g.,
Matulane], selegiline [e.g., Eldepryl],
tranylcypromine [e.g., Parnate]) or Neuroleptics
(e.g., Thorazine, Prolixin) - Taking these medicines
with tramadol may increase the possibility of seizures
or convulsions.
- Alcohol and products with alcohol in them or
- Anesthetic medicines or
- Central nervous system (CNS) depressants such as ,
narcotic pain relievers (e.g., Codeine, Darvon),
phenothiazines (e.g., Thorazine, Prolixin), sedative
hypnotics (e.g., Valium, Xanax), tranquilizers (e.g.,
Ativan, Haldol - Taking these medicines with tramadol
may increase the chance of serious side effects.
- Carbamazepine (e.g., Tegretol) - May decrease the
blood levels of Tramadol, which increases the chance
of serious side effects
- Monoamine oxidase (MAO) inhibitor activity
(isocarboxazid [e.g., Marplan], phenelzine [e.g.,
Nardil], procarbazine [e.g., Matulane], selegiline
[e.g., Eldepryl], tranylcypromine [e.g., Parnate])
(taken currently or within the past 2 weeks) - Taking
tramadol with these medicines may cause more of a
chance for seizures. It may also cause high blood
pressure, unusual heartbeats, or headache
- Selective serotonin reuptake inhibitors (SSRI)
(citalopram [e.g., Celexa], fluvoxamine [e.g., Luvox],
and sertraline [e.g., Zoloft] - Taking these medicines
with tramadol and acetaminophen may increase the
possibility of seizures or convulsions
Other medical problems - The presence of other
medical problems may affect the use of tramadol and
acetaminophen. Make sure you tell your doctor if you
have any other medical problems, especially:
- Alcohol and/or other drug abuse, or history of, or
- Convulsions (seizures), history of, or
- Head injury, or
- Hormonal problems or
- Infections of the central nervous system or
- Kidney disease or
- Liver disease, or
- Respiratory difficulty or troubled breathing, or
- Severe abdominal problems - The chance of serious
side effects may be increased
Proper Use of Ultracet
Take Ultracet only as
directed by your medical doctor or dentist. Do not take
more of it, do not take it more often, and do not take
it for a longer time than your medical doctor or dentist
ordered. This is especially important for young children
and elderly patients, who may be more sensitive than
other people to the effects of analgesics. If too much
of a analgesic is taken, it may become habit-forming
(causing mental or physical dependence) or lead to
medical problems because of an overdose. Taking too much
acetaminophen may cause liver damage.
Dosing
The dose of tramadol and acetaminophen 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
and acetaminophen. If your dose is different, do not
change it unless your doctor tells you to do so.
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 taking tramadol and acetaminophen
For oral dosage form (tablets):
For pain:
Adults and adolescents 16 years and
older - Take 2 tablets every 4-6 hours as needed for up
to 5 days. Children under 16 years of age-use and dose
must be determined by your doctor.
Storage
To store Ultracet:
Keep out of the reach of
children. Overdose of tramadol and acetaminophen is very
dangerous in young children. Do not store in the
bathroom, near the kitchen sink, or in other damp
places. heat or moisture may cause the medicine to break
down. Do not keep outdated medicine or medicine no
longer needed. Ask your health care professional how you
should dispose of any medicine you do not use. Be sure
that any discarded medicine is out of the reach of
children.
Precautions While Using Ultracet
The analgesic
in Ultracet will add to the effects of alcohol and other
CNS depressants (medicines that slow down the nervous
system, possibly causing drowsiness). Some examples of
CNS depressants are antihistamines or medicine for hay
fever, other allergies, or colds; sedatives,
tranquilizers, or sleeping medicine; other prescription
pain medicine or narcotics; opioids; barbiturates;
medicine for seizures; muscle relaxants; or anesthetics,
including some dental anesthetics. Also, there may be a
greater risk of liver damage if you drink three or more
alcoholic beverages while you are taking acetaminophen.
Do not drink alcoholic beverages, and check with your
medical doctor or dentist before taking any of the
medicines listed above, while you are using Ultracet.
Ultracet may cause some people to become drowsy,
dizzy, or less alert than they are normally. Make sure
you know how you react to Ultracet before you drive, use
machines, or do anything else that could be dangerous if
you are dizzy or are not alert.
Dizziness, lightheadedness, or fainting may occur,
especially when you get up suddenly from a lying or
sitting position. Getting up slowly may help lessen this
problem.
Nausea or vomiting may occur, especially after the
first couple of doses. This effect may go away if you
lie down for a while. However, if nausea or vomiting
continues, check with your medical doctor or dentist.
Lying down for a while may also help relieve some other
side effects, such as dizziness or lightheadedness, that
may occur.
Before having any kind of surgery (including dental
surgery) or emergency treatment, tell the medical doctor
or dentist in charge that you are taking Ultracet.
Analgesics may cause dryness of the mouth. For
temporary relief, use sugarless candy or gum, melt bits
of ice in your mouth, or use a saliva substitute.
However, if dry mouth continues for more than 2 weeks,
check with your dentist. Continuing dryness of the mouth
may increase the chance of dental disease, including
tooth decay, gum disease, and fungus infections.
If you have been taking Ultracet regularly , do not
suddenly stop taking it without first checking with your
doctor. Your doctor may want you to reduce gradually the
amount you are taking before stopping completely, to
lessen the chance of withdrawal side effects. This will
depend on which of these medicines you have been taking,
and the amount you have been taking every day.
Side Effects of Ultracet
Along with its needed
effects, a medicine may cause some unwanted effects.
Although not all of these side effects may occur, if
they do occur they may need medical attention.
Check with your doctor immediately if any of the
following side effects occur:
Rare
Burning, itching, and redness of skin; vomiting ;
chest pain; cough; difficulty swallowing; dizziness;
fast heartbeat; hives; itching; puffiness or swelling of
the eyelids or around the eyes, face, lips or tongue;
shortness of breath; skin rash; tightness in chest;
unusual tiredness or weakness; wheezing; seizures
Symptoms of Overdose
If you think you, or
someone else may have taken an overdose, get emergency
help at once. Get emergency help immediately if any of
the following symptoms of overdose occur
Chest pain or discomfort; convulsions ; difficulty
breathing
Other side effects may occur that usually do not need
medical attention. These side effects may go away during
treatment as your body adjusts to the medicine. However,
check with your doctor if any of the following side
effects continue or are bothersome.
Less common
Abdominal pain; aches, pains or weakness of muscles;
numbness or tingling of hands, legs, and feet; acid or
sour stomach; belching; heartburn; indigestion; stomach
discomfort ; anxiety; bloated full feeling; excess air
or gas in stomach or intestines; confusion;
constipation; dizziness; dry mouth; false or unusual
sense of well-being; feeling of warmth; redness of the
face, neck, arms, and occasionally the upper chest;
headache; increased sweating; increase in bowel
movements; loose stools; soft stools; itching skin; loss
of appetite; weight loss; loss of strength or energy;
muscle pain or weakness; mood or mental changes; nausea;
nervousness; painful or difficult urination; rash;
sleepiness or unusual drowsiness; sleeplessness; trouble
sleeping; unable to sleep; unusual tiredness or
weakness; vomiting
Rare
Abnormal thinking; bloody or black, tarry stools;
vomiting of blood or material that looks like coffee
grounds; sever stomach pain; constipation; blurred
vision; dizziness; severe or continuing, dull headache;
pounding in the ears; slow or fast heartbeat; change in
vision; chills; cold sweats; confusion; dizziness;
faintness, or light-headedness when getting up from
lying or sitting position; continuing ringing or buzzing
or other unexplained noise in ears; crying;
depersonalization; dysphoria; euphoria; mental
depression; paranoia; quick to react or overreact
emotionally; rapidly changing moods ; decreased
awareness or responsiveness; decrease in amount of
urine; decrease in urine volume; decrease in frequency
of urination; difficulty in passing urine [dribbling];
painful urination; depression ; difficulty swallowing;
dizziness or lightheadedness; feeling of constant
movement of self or surroundings; sensation of spinning;
drug abuse and dependence ; fainting; fast, pounding, or
irregular heartbeat or pulse; palpitations; feeling
unusually cold; shivering ; high or low blood pressure;
dizziness; lightheadedness ; increased muscle tone;
involuntary muscle contractions; loss in sexual ability,
desire, drive, or performance; decreased interest in
sexual intercourse; inability to have or keep an
erection; loss of memory; problems with memory; loss of
sense of reality; morbid dreaming; migraine headache;
seeing, hearing, or feeling things that are not there;
shakiness and unsteady walk; clumsiness, unsteadiness,
trembling, or other problems with muscle control or
coordination; shortness of breath; difficult or labored
breathing; tightness in chest; wheezing ; swelling of
tongue; trouble in holding or releasing urine; painful
urination; unusual tiredness or weakness; weight loss;
yellow eyes or skin
After you stop using Ultracet, your body may need
time to adjust. The length of time this takes depends on
which of these medicines you were taking, the amount of
medicine you were using, and how long you used it.
During this time check with your doctor if you notice
any of the following side effects:
Anxiety; diarrhea; fever, runny nose, or sneezing ;
gooseflesh; increased sweating; nausea or vomiting;
nervousness, restlessness, or irritability; pain ;
seeing, hearing, or feeling things that are not there;
shivering or trembling; trouble in sleeping
Other side effects not listed above may also occur in
some patients. If you notice any other effects, check
with your doctor. |
