|
What is the most important information I should know about metformin
and rosiglitazone?
|
|
• |
A small number of people who have taken metformin (with and without
rosiglitazone), have developed a serious condition called lactic
acidosis that has been fatal in up to 50% of cases. Lactic acidosis has
occurred most often in people whose kidneys were not working properly.
Liver problems may also increase the risk of developing lactic acidosis.
Stop taking metformin and rosiglitazone and call your doctor immediately
if you experience a feeling of general discomfort or sickness; weakness;
sore or aching muscles; trouble breathing, unusual drowsiness, dizziness
or lightheadedness; unusual or unexplained stomach upset (after the
initial stomach upset that may occur at the start of therapy with
metformin and rosiglitazone); or the sudden development of a slow or
irregular heartbeat. These may be signs of lactic acidosis. |
|
• |
Notify your doctor immediately if you experience an unusually rapid
increase in weight or edema (water retention), shortness of breath, or
chest pain during treatment with metformin rosiglitazone. These may be
early symptoms of heart problems. |
|
• |
Notify your doctor immediately if you develop nausea, vomiting,
abdominal pain, unusual fatigue, loss of appetite, yellow skin or eyes,
or dark urine. These symptoms may be early signs of liver problems. |
|
• |
Avoid excessive alcohol intake while taking metformin and
rosiglitazone. Together, alcohol and metformin and rosiglitazone may
increase the risk of lactic acidosis and hypoglycemia. |
|
• |
Metformin and rosiglitazone does not usually cause hypoglycemia (low
blood sugar). Nevertheless, hypoglycemia may occur, as a result of
skipped meals, excessive exercise, or alcohol consumption. Know the
signs and symptoms of low blood sugar, which include hunger, headache,
drowsiness, weakness, dizziness, a fast heartbeat, sweating, tremor, and
nausea. Carry a non-dietetic candy or glucose tablets to treat episodes
of low blood sugar. |
|
What is metformin and rosiglitazone?
|
|
• |
Metformin is used to regulate blood glucose (sugar) levels.
Metformin works in three ways: first, it reduces the amount of glucose
produced by the liver; second, it reduces the amount of glucose absorbed
from food through the stomach; and third, it makes the insulin that the
body produces work better to reduce the amount of glucose already in the
blood. |
|
• |
Rosiglitazone is an antihyperglycemic agent. It helps the body
respond better to insulin and it reduces the amount of sugar produced by
the liver. It can help control blood sugar levels. |
|
• |
Metformin and rosiglitazone are used together in the treatment of
type 2 diabetes. |
|
• |
Metformin and rosiglitazone may also be used for purposes other than
those listed in this medication guide. |
|
What should I discuss with my healthcare provider before taking
metformin and rosiglitazone?
|
|
• |
Do not take metformin and rosiglitazone without first talking to
your doctor if you |
| |
· |
have liver or kidney disease; |
| |
· |
have acute or chronic metabolic acidosis, including diabetic
ketoacidosis; |
| |
· |
have congestive heart failure; |
| |
· |
have had a heart attack or a stroke; |
| |
· |
have a serious infection, illness, or injury; |
| |
· |
need to have x-rays or other procedures using injectable contrast
agents; |
| |
· |
are dehydrated (have lost water from your body) due to diarrhea,
vomiting, fever, heat stroke, decreased fluid intake, or any other cause; |
| |
· |
have edema (water retention or swelling); |
| |
· |
are 80 years of age or older and have not had your kidney function
tested. |
|
• |
You may not be able to take metformin and rosiglitazone, or you may
require a dosage adjustment or special monitoring during treatment if
you have any of the conditions listed above. |
|
• |
Treatment with metformin and rosiglitazone may cause resumption of
fertility by allowing the return of ovulation (production of eggs) in
certain women with insulin resistance who were not ovulating before
treatment with metformin and rosiglitazone. Talk to your doctor about
adequate forms of birth control while taking metformin and rosiglitazone
if birth control is desired. |
|
• |
Contact your doctor if you develop a fever or an infection, require
surgery, or if you experience a serious injury. Illness or injury may
cause a loss of blood sugar control and insulin (or an adjustment of a
current insulin dose) may be required for a period of time. |
|
• |
Metformin and rosiglitazone is in the FDA pregnancy category C. This
means that it is not known whether it will be harmful to an unborn baby.
Generally, insulin is the drug of choice for controlling diabetes during
pregnancy. Do not take metformin and rosiglitazone without first talking
to your doctor if you are pregnant or could become pregnant during
treatment. |
|
• |
It is not known whether metformin and rosiglitazone passes into
breast milk. Do not take metformin and rosiglitazone without first
talking to your doctor if you are breast-feeding a baby. |
|
• |
If you are over the age of 65 years, there may be an slight increase
in the risk of developing lactic acidosis due to a natural decline in
kidney function with advancing age. A lower dose or special monitoring
may be necessary during treatment. |
|
How should I take metformin and rosiglitazone?
|
|
• |
Take metformin and rosiglitazone exactly as directed by your doctor.
If you do not understand these directions, ask your pharmacist, nurse,
or doctor to explain the instructions to you. |
|
• |
Take each dose with a full glass of water. |
|
• |
Take metformin and rosiglitazone with meals to reduce nausea,
diarrhea, and upset stomach that may occur with metformin and
rosiglitazone therapy. These symptoms may be more likely to occur during
the first few weeks of therapy. |
|
• |
It is important to take metformin and rosiglitazone regularly to get
the most benefit. |
|
• |
A decrease in vitamin B12 may also occur during metformin and
rosiglitazone therapy. Your doctor may want to monitor blood levels of
vitamin B12 and you may need to take a B12 supplement. A vitamin B12
deficiency may rarely cause anemia. |
|
• |
Your doctor may want to monitor your blood sugar control and other
factors with blood tests during treatment. |
|
• |
Usually, liver function is monitored with blood tests at the start
of treatment, every two months for the first year of treatment, and
periodically thereafter during treatment with rosiglitazone. Notify your
doctor immediately if you develop nausea, vomiting, abdominal pain,
unusual fatigue, loss of appetite, yellow skin or eyes, or dark urine.
These symptoms may be early signs of liver problems. |
|
• |
Store metformin and rosiglitazone at room temperature away from
moisture and heat. |
|
What happens if I miss a dose?
|
|
• |
Take the missed dose as soon as you remember. However, if it is
almost time for the next dose, skip the missed dose and only take the
next regularly scheduled dose. Do not take a double dose. |
|
What happens if I overdose?
|
|
• |
Seek emergency medical attention if an overdose is suspected. |
|
• |
An overdose of metformin and rosiglitazone is likely to cause lactic
acidosis. Symptoms of lactic acidosis include a feeling of general
discomfort or sickness; weakness; sore or aching muscles; trouble
breathing; unusual drowsiness, dizziness or lightheadedness; unusual or
unexplained stomach upset (after the initial stomach upset that may
occur at the start of therapy with metformin and rosiglitazone); and the
sudden development of a slow or irregular heartbeat. |
|
What should I avoid while taking metformin and rosiglitazone?
|
|
• |
Some conditions may increase the risk of developing lactic acidosis
while taking metformin and rosiglitazone. Tell your doctor that you are
taking metformin and rosiglitazone if you become ill; if you have a
heart attack; have a stroke; develop congestive heart failure;
experience diarrhea, vomiting, fever, or dehydration from any cause;
decrease the amount of food or liquid in your normal diet, or develop
other health conditions. You may need to stop treatment with metformin
and rosiglitazone for a short amount of time until you are feeling
better. |
|
• |
Avoid excessive alcohol intake while taking metformin and
rosiglitazone. Together, alcohol and metformin and rosiglitazone may
increase the risk of lactic acidosis and hypoglycemia. |
|
• |
Follow diet, medication, and exercise routines very closely.
Changing any of these things can affect blood sugar levels. |
|
• |
Tell your doctor or other health care provider that you are taking
this medication if you need to have surgery or x-ray procedures that
require injection of contrast agents. Treatment with metformin and
rosiglitazone may need to be stopped for a short period of time. |
|
What are the possible side effects of metformin and rosiglitazone?
|
|
• |
Stop taking metformin and rosiglitazone and seek emergency medical
attention if you experience an allergic reaction (difficulty breathing;
closing of the throat; swelling of the lips, tongue, or face; or hives). |
|
• |
Notify your doctor immediately if you develop nausea, vomiting,
abdominal pain, unusual fatigue, loss of appetite, yellow skin or eyes,
or dark urine. These symptoms may be early signs of liver problems. |
|
• |
Notify your doctor immediately if you experience an unusually rapid
increase in weight or edema (water retention), shortness of breath, or
chest pain during treatment with metformin rosiglitazone. These may be
early symptoms of heart problems. |
|
• |
A small number of people who have taken metformin (with and without
rosiglitazone), have developed a serious condition called lactic
acidosis that has been fatal in up to 50% of cases. Lactic acidosis has
occurred most often in people whose kidneys were not working properly.
Liver problems may also increase the risk of developing lactic acidosis.
Stop taking metformin and rosiglitazone and call your doctor immediately
if you experience a feeling of general discomfort or sickness; weakness;
sore or aching muscles; trouble breathing, unusual drowsiness, dizziness
or lightheadedness; unusual or unexplained stomach upset (after the
initial stomach upset that may occur at the start of therapy with
metformin and rosiglitazone); or the sudden development of a slow or
irregular heartbeat. These may be signs of lactic acidosis. |
|
• |
Metformin and rosiglitazone does not usually cause hypoglycemia (low
blood sugar). Nevertheless, hypoglycemia may occur, as a result of
skipped meals, excessive exercise, or alcohol consumption. Know the
signs and symptoms of low blood sugar, which include hunger, headache,
drowsiness, weakness, dizziness, a fast heartbeat, sweating, tremor, and
nausea. Carry a non-dietetic candy or glucose tablets to treat episodes
of low blood sugar. |
|
• |
Other, less serious side effects may be more likely to occur.
Continue to take metformin and rosiglitazone and talk to your doctor if
you experience |
| |
· |
nausea, vomiting, abdominal pain, or diarrhea at the start of
therapy; |
| |
· |
abdominal bloating or increased gas production; |
| |
· |
decreased appetite or changes in taste (metallic taste in the mouth); |
| |
· |
cold-like symptoms (may indicate an upper respiratory tract
infection); |
|
• |
Side effects other than those listed here may also occur. Talk to
your doctor about any side effect that seems unusual or that is
especially bothersome. |
|
What other drugs will affect metformin and rosiglitazone?
|
|
• |
Do not take any over-the-counter cough, cold, allergy, pain, or
weight loss medications without first talking to your doctor. |
|
• |
Many drugs may interact with metformin and rosiglitazone or affect
your condition. Talk to your doctor and pharmacist before taking any
prescription or over-the-counter medicines, including vitamins, minerals,
and herbal products. |
|
Where can I get more information?
|
|
• |
Your pharmacist has more information about metformin and
rosiglitazone written for health professionals that you may read. |
|
• |
Remember, keep this and all other medicines out of the reach of
children, never share your medicines with others, and use this
medication only for the indication prescribed. |
|
• |
Every effort has been made to ensure that the information provided
by Cerner Multum, Inc. ('Multum') is accurate, up-to-date, and complete,
but no guarantee is made to that effect. Drug information contained
herein may be time sensitive. Multum information has been compiled for
use by healthcare practitioners and consumers in the United States and
therefore Multum does not warrant that uses outside of the United States
are appropriate, unless specifically indicated otherwise. Multum's drug
information does not endorse drugs, diagnose patients or recommend
therapy. Multum's drug information is an informational resource designed
to assist licensed healthcare practitioners in caring for their patients
and/ or to serve consumers viewing this service as a supplement to, and
not a substitute for, the expertise, skill, knowledge and judgment of
healthcare practitioners. The absence of a warning for a given drug or
drug combination in no way should be construed to indicate that the drug
or drug combination is safe, effective or appropriate for any given
patient. Multum does not assume any responsibility for any aspect of
healthcare administered with the aid of information Multum provides. The
information contained herein is not intended to cover all possible uses,
directions, precautions, warnings, drug interactions, allergic reactions,
or adverse effects. If you have questions about the drugs you are taking,
check with your doctor, nurse or pharmacist. |
Copyright 1996-2004 Cerner Multum, Inc. Version: 3.01. Revision date: 4/
16/ 04. |