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MERIDIA
MERIDIA ONLINE
Before Using This Medicine
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 sibutramine, the following
should be considered:
Allergies—Tell your doctor if you have ever
had any unusual or allergic reaction to sibutramine. Also tell
your health care professional if you are allergic to any other
substances, such as foods, preservatives, or dyes.
Diet—You must follow a reduced-calorie diet
while taking sibutramine in order to lose weight and keep the lost
weight from returning.
Pregnancy—Sibutramine has not been studied
in pregnant women. However, studies in animals have shown that
sibutramine causes birth defects when used in doses many times
higher than the usual human dose. Before taking this medicine,
make sure your doctor knows if you are pregnant or if you may
become pregnant.
Breast-feeding—It is not known whether
sibutramine passes into breast milk. Although most medicines pass
into breast milk in small amounts, many of them may be used safely
while breast-feeding. A mother who is taking this medicine and who
wishes to breast-feed should discuss this with her doctor.
Children—Studies on this medicine have been
done only in adult patients, and there is no specific information
comparing use of sibutramine in children with use in other age
groups.
Older adults—Many medicines have not been
studied specifically in older people. Therefore, it may not be
known whether they work exactly the same way they do in younger
adults. Although there is no specific information comparing use of
sibutramine in the elderly with use in other age groups, this
medicine is not expected 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 sibutramine, it
is especially important that your health care professional know if
you are taking any of the following:
 | Appetite suppressants, other (benzphetamine [e.g., Didrex],
diethylpropion [e.g., Tenuate], mazindol [e.g., Sanorex],
phendimetrazine [e.g., Phendiet], phentermine [e.g.,
Ionamin])—The effects of using sibutramine in combination
with another appetite suppressant are not known |
| Bromocriptine (e.g., Parlodel) or
| Buspirone (e.g., BuSpar) or
| Certain tricyclic antidepressants (amitriptyline [e.g.,
Elavil], clomipramine [e.g., Anafranil], imipramine [e.g.,
Tofranil]) or
| Dextromethorphan (cough medicine) or
| Levodopa (e.g., Sinemet) or
| Lithium (e.g., Eskalith) or
| Meperidine (e.g., Demerol) or
| Nefazodone (e.g., Serzone) or
| Pentazocine (e.g., Talwin) or
| Selective serotonin reuptake inhibitors (citalopram [e.g.,
Celexa], fluoxetine [e.g., Prozac], fluvoxamine [e.g., Luvox],
paroxetine [e.g., Paxil], sertraline [e.g., Zoloft]) or
| Street drugs (LSD, MDMA [e.g., ecstasy], marijuana) or
| Sumatriptan (e.g., Imitrex) or
| Tramadol (e.g., Ultram) or
| Trazodone (e.g., Desyrel) or
| Tryptophan or
| Venlafaxine (e.g., Effexor)—Using these medicines with
sibutramine may increase the chance of developing a rare, but
very serious, unwanted effect known as the serotonin syndrome.
Symptoms of this syndrome include confusion, diarrhea, fever,
poor coordination, restlessness, shivering, sweating, talking
or acting with excitement you cannot control, trembling or
shaking, or twitching. If you develop these symptoms, contact
your doctor as soon as possible |
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| Moclobemide (e.g., Manerex)—Taking moclobemide and
sibutramine together or less than 3 days apart may increase
the chance of developing serious unwanted effects, including
the serotonin syndrome, and is not recommended |
| 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])— Do not take sibutramine while you are
taking or within 2 weeks of taking an MAO inhibitor, and do
not take an MAO inhibitor within 2 weeks of taking sibutramine
. If you do, you may develop severe seizures, extremely
high blood pressure, or the serotonin syndrome. Allow at least
2 weeks to pass between taking one of these medicines (sibutramine
or an MAO inhibitor) and taking the other |
Proper Use of This Medicine
Take this medicine only as directed. Do not take more
of it, do not take it more often, and do not take it for a longer
time than directed by your doctor. To do so may increase the
chance of developing unwanted effects, such as high blood
pressure.
Follow a reduced-calorie diet while taking sibutramine, as
directed by your doctor.
Sibutramine may be taken with or without food, on a full or
empty stomach. However, if your doctor tells you to take it in a
certain way, take it as directed.
Dosing—
The dose of sibutramine 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 sibutramine. If your dose is different, do not change
it unless your doctor tells you to do so.
The number of capsules that you take depends on the strength of
the medicine.
| For oral dosage form (capsules):
| For weight loss:
| Adults—At first, 10 milligrams (mg) one time a
day, usually in the morning. Your doctor may increase
or decrease your dose if needed. However, the dose is
usually not more than 15 mg a day.
| Children—Use and dose must be determined by the
doctor. |
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Missed dose—
If you miss a dose of sibutramine and you remember it within 2
to 3 hours, take it as soon as possible. If you do not remember
the missed dose until later, skip the missed dose and return to
your regular dosing schedule. Do not double doses.
Storage—
To store this medicine:
| Keep out of the reach of children.
| Store away from heat and direct light.
| 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.
Be sure that any discarded medicine is out of the reach of
children. |
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Precautions While Using This Medicine
It is important that your doctor check your progress at
regular visits. Sibutramine may increase blood pressure or
heart rate and your doctor will check for these effects. Your
doctor may need to adjust your dose.
If sibutramine does not seem to be working well, do not
increase your dosage. Check with your doctor.
Do not take sibutramine while you are taking or within 2
weeks of taking medicines with monoamine oxidase (MAO) inhibitor
activity , such as isocarboxazid (e.g., Marplan), phenelzine
(e.g., Nardil), procarbazine (e.g., Matulane), selegiline (e.g.,
Eldepryl), or tranylcypromine (e.g., Parnate). Do not take an
MAO inhibitor within 2 weeks of taking sibutramine. To do so
may cause severe seizures, extremely high blood pressure, or a
life-threatening adverse effect called the serotonin syndrome.
Do not drink excess alcohol while taking sibutramine.
Notify your doctor as soon as possible if you develop a
skin rash, hives, or other allergic symptoms.
Sibutramine may cause dizziness, drowsiness, or poor judgment. Be
sure you know how you react to this medicine before you drive,
operate machinery, or do other things that could be dangerous if
you are not alert and able to think clearly.
Sibutramine 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 your mouth
continues to feel dry for more than 2 weeks, check with your
medical doctor or dentist. Continuing dryness of the mouth may
increase the chance of dental disease, including tooth decay, gum
disease, and fungus infections.
Side Effects of This Medicine
Side Effects of This Medicine
Along with its needed effects, a medicine may cause some
unwanted effects. Some of these effects, such as high blood
pressure, may not have signs or symptoms that you can see or feel.
While you are taking sibutramine, your doctor will check your
blood pressure and heart rate at regular visits.
Although not all of these side effects may occur, if they do
occur they may need medical attention.
Check with your doctor as soon as possible if any of the
following side effects occur:
| Less common
| Achiness; chills; fast or irregular
heartbeat; increased blood pressure ; mental
depression; painful menstruation; swelling of
body or of feet and ankles |
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| Rare
| Bruising or red spots or patches on skin;
convulsions (seizures); excessive bleeding following
injury; headache (severe); rapidly changing
moods; skin rash; weight gain (unusual) |
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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:
| More common
| Anxiety; constipation; dizziness;
dryness of mouth; headache; irritability or
unusual impatience ; nervousness; stuffy or
runny nose; trouble in sleeping |
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| Less common
| Abdominal pain; back pain; burning, itching,
prickling, or tingling of skin; change in sense of
taste; diarrhea; drowsiness; increase in
appetite; increased sweating; increased thirst
; indigestion; nausea; unusual warmth or
flushing of skin |
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Other side effects not listed above may also occur in some
patients. If you notice any other effects, check with your doctor.
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