Actos
Description
ACTOS is a once-a-day prescription pill for type 2 diabetes that along with healthy eating and physical activity helps your body more effectively use its own natural insulin or the insulin you take. When your necessary efforts at healthy eating and physical activity alone do not control your blood glucose levels, ACTOS can be used by itself or in combination with certain other diabetes pills (sulfonylureas, metformin) or insulin to lower blood glucose.
ACTOS is a member of the type of oral diabetes agents called thiazolidinediones (THIGH-ah-ZO-li-deen-DYE-owns; TZDs). These medications help reduce insulin resistance, which has been identified as one of the major problems in type 2 diabetes. Some of the benefits of therapy with ACTOS are:
- It lowers blood glucose by helping your body use insulin more effectively.
- It is a convenient, once-a-day pill that can be taken anytime.
- It can be taken with or without food.
- It may have a good effect on HDL (good) cholesterol and blood fats (triglycerides) with no consistent changes in LDL (bad) cholesterol or total cholesterol.
- It has not been associated with stomach upset when used alone.
- It can be used alone or in combination with certain other diabetes medicines such as sulfonylureas, metformin, or insulin.
It can often begin working within 2 weeks, although it may take several weeks to see the full effect.
Recommendations
Follow the directions for using this medicine provided by your doctor. This medicine may be taken on an empty stomach or with food. STORE THIS MEDICINE at room temperature at 77 degrees F (25 degrees C) in a tightly-closed container, away from heat, moisture, and light.
IF YOU MISS A DOSE OF THIS MEDICINE, take it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do NOT take 2 doses at once.
DO NOT STOP USING THIS MEDICINE or other diabetes medicine without first checking with your doctor. CHECK WITH YOUR DOCTOR before adjusting the dose of your diabetes medicine or changing your diet.
KEEP ALL DOCTOR AND LABORATORY APPOINTMENTS while you are using this medicine. Laboratory and/or medical tests such as liver function tests and HBA1C blood levels may be done to monitor your progress or to check for side effects.
BEFORE YOU HAVE ANY MEDICAL OR DENTAL TREATMENTS, EMERGENCY CARE, OR SURGERY, tell the doctor or dentist that you are using this medicine.
BEFORE YOU BEGIN TAKING ANY NEW MEDICINE, either prescription or over-the-counter, check with your doctor or pharmacist.
FOR WOMEN TAKING BIRTH CONTROL PILLS: this medicine may decrease the effectiveness of your birth control pill. To prevent pregnancy, use an additional form of birth control.
IF YOU PLAN ON BECOMING PREGNANT, discuss with your doctor the benefits and risks of using this medicine during pregnancy.
Terry Brownswill, GA, 32:
I was diagnosed with Type II diabetes last November (2004) and my fasting blood sugar was 140 mg/dl, while my A1C test was 7.3 %HbA1c. Since November of 2004, I have been working to control my blood sugar with diet and exercise, which has helped reduce my fasting blood sugar to a weekly average of 130 mg/dl.
I heard about Actos about a month ago and I started taking it two weeks ago. Now, my average weekly fasting blood sugar is down to 116 mg/dl and my A1C test on April 4th indicated a 2-3 month average of 6.7 %HbA1c. I am convinced that Actos has provided me with the assistance needed to further control my diabetes naturally with diet and daily exercise.
Thank you, Pharmacy for bringing this fine product to my door.
Ron Brooks, IL, 44:
After the first week of taking Actos I could already see huge improvement in my blood sugar levels. Two weeks into the treatment, I threw all my medications that I had been prescribed away, and decided to rely only on the product.
In 1990 I was diagnosed with Type II Diabetes. Throughout the course of 13+ years I tried several different medications that my doctor prescribed. As time went by, symptoms developed such as numbness in my feet, blurry vision, high blood pressure, high cholesterol, and weight gain. The medication that I was taking did not seem to be helping with any of these. And although I knew that it was important to keep my weight down, it seemed extremely difficult to do, as I was hungry all the time and craved sweets such as doughnuts and chocolate shakes.
Over the last 9 months my blood pressure has improved, my high cholesterol has gone down to the normal range, and I have lost 55 pounds. I still have my sweet tooth and like to indulge sometimes with a doughnut and a chocolate shake, but my appetite is not like it was. I can enjoy these pleasures in moderation.
The last time I visited my blood test was 6.7. I am so thrilled that I was fortunate enough to find a way to change my life in such a positive way. I can enjoy a normal life and will be able to spend many more years enjoying the things I love to do.
Pioglitazone [(±)-5-[[4-[2-(5-ethyl-2-pyridinyl)ethoxy]phenyl]methyl]-2,4-]
thiazolidinedione monohydrochloride belongs to a different chemical class
and has a different pharmacological action than the sulfonylureas, metformin,
or the ?-glucosidase inhibitors. The molecule contains one asymmetric carbon,
and the compound is synthesized and used as the racemic mixture. The
two enantiomers of pioglitazone interconvert in vivo. No differences were
found in the pharmacologic activity between the two enantiomers.
Pioglitazone hydrochloride is an odorless white crystalline powder that has a
molecular formula of C19H20N2O3S•HCl and a molecular weight of 392.90 daltons.
It is soluble in N,N-dimethylformamide, slightly soluble in anhydrous
ethanol, very slightly soluble in acetone and acetonitrile, practically insoluble
in water, and insoluble in ether.
Answer these questions to find out if ACTOS may be right for you:
-Are your premeal blood glucose levels consistently above 130 mg/dL?
-Are you having problems managing your diabetes with healthy eating and physical activity alone?
-Are you having problems managing your diabetes with your current oral medications or insulin injections?
-Do you prefer taking a medication only once a day?
-Are you interested in a diabetes drug that may have a positive effect on HDL (good) cholesterol and triglyceride levels?
If you have type 2 diabetes and answered "yes" to any of these questions, ask your health professional if ACTOS is right for you. Remember, only your health professional can determine the best treatment for you.
Precautions
DO NOT STOP USING THIS MEDICINE or other diabetes medicine without first checking with your doctor. CHECK WITH YOUR DOCTOR before adjusting the dose of your diabetes medicine or changing your diet.
KEEP ALL DOCTOR AND LABORATORY APPOINTMENTS while you are using this medicine. Laboratory and/or medical tests such as liver function tests and HBA1C blood levels may be done to monitor your progress or to check for side effects.
BEFORE YOU HAVE ANY MEDICAL OR DENTAL TREATMENTS, EMERGENCY CARE, OR SURGERY, tell the doctor or dentist that you are using this medicine.
BEFORE YOU BEGIN TAKING ANY NEW MEDICINE, either prescription or over-the-counter, check with your doctor or pharmacist.
FOR WOMEN TAKING BIRTH CONTROL PILLS: this medicine may decrease the effectiveness of your birth control pill. To prevent pregnancy, use an additional form of birth control.
IF YOU PLAN ON BECOMING PREGNANT, discuss with your doctor the benefits and risks of using this medicine during pregnancy.
Terry Brownswill, GA, 32:
I was diagnosed with Type II diabetes last November (2004) and my fasting blood sugar was 140 mg/dl, while my A1C test was 7.3 %HbA1c. Since November of 2004, I have been working to control my blood sugar with diet and exercise, which has helped reduce my fasting blood sugar to a weekly average of 130 mg/dl.
I heard about Actos about a month ago and I started taking it two weeks ago. Now, my average weekly fasting blood sugar is down to 116 mg/dl and my A1C test on April 4th indicated a 2-3 month average of 6.7 %HbA1c. I am convinced that Actos has provided me with the assistance needed to further control my diabetes naturally with diet and daily exercise.
Thank you, Pharmacy for bringing this fine product to my door.
Ron Brooks, IL, 44:
After the first week of taking Actos I could already see huge improvement in my blood sugar levels. Two weeks into the treatment, I threw all my medications that I had been prescribed away, and decided to rely only on the product.
In 1990 I was diagnosed with Type II Diabetes. Throughout the course of 13+ years I tried several different medications that my doctor prescribed. As time went by, symptoms developed such as numbness in my feet, blurry vision, high blood pressure, high cholesterol, and weight gain. The medication that I was taking did not seem to be helping with any of these. And although I knew that it was important to keep my weight down, it seemed extremely difficult to do, as I was hungry all the time and craved sweets such as doughnuts and chocolate shakes.
Over the last 9 months my blood pressure has improved, my high cholesterol has gone down to the normal range, and I have lost 55 pounds. I still have my sweet tooth and like to indulge sometimes with a doughnut and a chocolate shake, but my appetite is not like it was. I can enjoy these pleasures in moderation.
The last time I visited my blood test was 6.7. I am so thrilled that I was fortunate enough to find a way to change my life in such a positive way. I can enjoy a normal life and will be able to spend many more years enjoying the things I love to do.
Pioglitazone [(±)-5-[[4-[2-(5-ethyl-2-pyridinyl)ethoxy]phenyl]methyl]-2,4-]
thiazolidinedione monohydrochloride belongs to a different chemical class
and has a different pharmacological action than the sulfonylureas, metformin,
or the ?-glucosidase inhibitors. The molecule contains one asymmetric carbon,
and the compound is synthesized and used as the racemic mixture. The
two enantiomers of pioglitazone interconvert in vivo. No differences were
found in the pharmacologic activity between the two enantiomers.
Pioglitazone hydrochloride is an odorless white crystalline powder that has a
molecular formula of C19H20N2O3S•HCl and a molecular weight of 392.90 daltons.
It is soluble in N,N-dimethylformamide, slightly soluble in anhydrous
ethanol, very slightly soluble in acetone and acetonitrile, practically insoluble
in water, and insoluble in ether.
Answer these questions to find out if ACTOS may be right for you:
-Are your premeal blood glucose levels consistently above 130 mg/dL?
-Are you having problems managing your diabetes with healthy eating and physical activity alone?
-Are you having problems managing your diabetes with your current oral medications or insulin injections?
-Do you prefer taking a medication only once a day?
-Are you interested in a diabetes drug that may have a positive effect on HDL (good) cholesterol and triglyceride levels?
If you have type 2 diabetes and answered "yes" to any of these questions, ask your health professional if ACTOS is right for you. Remember, only your health professional can determine the best treatment for you.
General
ACTOS exerts its antihyperglycemic effect only in the presence of insulin.
Therefore, ACTOS should not be used in patients with type 1 diabetes or for the
treatment of diabetic ketoacidosis.
Hypoglycemia: Patients receiving ACTOS in combination with insulin or oral
hypoglycemic agents may be at risk for hypoglycemia, and a reduction in the
dose of the concomitant agent may be necessary.
Cardiovascular: In U.S. placebo-controlled clinical trials that excluded patients
with New York Heart Association (NYHA) Class III and IV cardiac status, the
incidence of serious cardiac adverse events related to volume expansion was
not increased in patients treated with ACTOS as monotherapy or in combination
with sulfonylureas or metformin vs. placebo-treated patients. In insulin
combination studies, a small number of patients with a history of previously
existing cardiac disease developed congestive heart failure when treated with
ACTOS in combination with insulin (see WARNINGS). Patients with NYHA
Class III and IV cardiac status were not studied in these ACTOS clinical trials.
ACTOS is not indicated in patients with NYHA Class III or IV cardiac
status.
In postmarketing experience with ACTOS, cases of congestive heart failure
have been reported in patients both with and without previously known heart
disease.
Edema: ACTOS should be used with caution in patients with edema. In all U.S.
clinical trials, edema was reported more frequently in patients treated with
ACTOS than in placebo-treated patients and appears to be dose related (see
ADVERSE REACTIONS). In postmarketing experience, reports of initiation or
worsening of edema have been received.
Weight Gain: Dose related weight gain was seen with ACTOS alone and in combination
with other hypoglycemic agents. The mechanism of weight
gain is unclear but probably involves a combination of fluid retention and fat accumulation.
Ovulation: Therapy with ACTOS, like other thiazolidinediones, may result in
ovulation in some premenopausal anovulatory women. As a result, these
patients may be at an increased risk for pregnancy while taking ACTOS. Thus,
adequate contraception in premenopausal women should be recommended.
This possible effect has not been investigated in clinical studies so the frequency
of this occurrence is not known.
Hematologic: ACTOS may cause decreases in hemoglobin and hematocrit.
Across all clinical studies, mean hemoglobin values declined by 2% to 4% in
patients treated with ACTOS. These changes primarily occurred within the
first 4 to 12 weeks of therapy and remained relatively constant thereafter. These
changes may be related to increased plasma volume and have rarely been associated
with any significant hematologic clinical effects (see ADVERSE REACTIONS,
Laboratory Abnormalities).
Hepatic Effects: In pre-approval clinical studies worldwide, over 4500 subjects
were treated with ACTOS. In U.S. clinical studies, over 4700 patients with type
2 diabetes received ACTOS. There was no evidence of drug-induced hepatotoxicity
or elevation of ALT levels in the clinical studies.
During pre-approval placebo-controlled clinical trials in the U.S., a total of 4
of 1526 (0.26%) patients treated with ACTOS and 2 of 793 (0.25%) placebotreated
patients had ALT values ? 3 times the upper limit of normal. The ALT
elevations in patients treated with ACTOS were reversible and were not clearly
related to therapy with ACTOS.
In postmarketing experience with ACTOS, reports of hepatitis and of hepatic
enzyme elevations to 3 or more times the upper limit of normal have been
received. Very rarely, these reports have involved hepatic failure with and without
fatal outcome, although causality has not been established.
Pioglitazone is structurally related to troglitazone, a thiazolidinedione no
longer marketed in the United States, which was associated with idiosyncratic
hepatotoxicity and cases of liver failure, liver transplants and death during
postmarketing clinical use. In pre-approval controlled clinical trials in
patients with type 2 diabetes, troglitazone was more frequently associated
with clinically significant elevations of hepatic enzymes (ALT > 3 times the
upper limit of normal) compared to placebo, and cases of reversible jaundice
were reported.
Pending the availability of the results of additional large, long-term controlled
clinical trials and additional postmarketing safety data, it is recommended
that patients treated with ACTOS undergo periodic monitoring of liver
enzymes.
Serum ALT (alanine aminotransferase) levels should be evaluated prior to the
initiation of therapy with ACTOS in all patients and periodically thereafter per
the clinical judgment of the health care professional. Liver function tests
should also be obtained for patients if symptoms suggestive of hepatic dysfunction
occur, e.g., nausea, vomiting, abdominal pain, fatigue, anorexia, or
dark urine. The decision whether to continue the patient on therapy with ACTOS
should be guided by clinical judgment pending laboratory evaluations. If jaundice
is observed, drug therapy should be discontinued.
Therapy with ACTOS should not be initiated if the patient exhibits clinical
evidence of active liver disease or the ALT levels exceed 2.5 times the upper
limit of normal. Patients with mildly elevated liver enzymes (ALT levels at 1 to
2.5 times the upper limit of normal) at baseline or any time during therapy
with ACTOS should be evaluated to determine the cause of the liver enzyme
elevation. Initiation or continuation of therapy with ACTOS in patients with
mildly elevated liver enzymes should proceed with caution and include appropriate
clinical follow-up which may include more frequent liver enzyme monitoring.
If serum transaminase levels are increased (ALT > 2.5 times the upper
limit of normal), liver function tests should be evaluated more frequently until
the levels return to normal or pretreatment values. If ALT levels exceed 3 times
the upper limit of normal, the test should be repeated as soon as possible. If
ALT levels remain > 3 times the upper limit of normal or if the patient is jaundiced,
ACTOS therapy should be discontinued.
There are no data available to evaluate the safety of ACTOS in patients who
experienced liver abnormalities, hepatic dysfunction, or jaundice while on
troglitazone. ACTOS should not be used in patients who experienced jaundice
while taking troglitazone.
Ingredients
Pioglitazone [(±)-5-[[4-[2-(5-ethyl-2-pyridinyl)ethoxy]phenyl]methyl]-2,4-]
thiazolidinedione monohydrochloride belongs to a different chemical class
and has a different pharmacological action than the sulfonylureas, metformin,
or the ?-glucosidase inhibitors. The molecule contains one asymmetric carbon,
and the compound is synthesized and used as the racemic mixture. The
two enantiomers of pioglitazone interconvert in vivo. No differences were
found in the pharmacologic activity between the two enantiomers.
Pioglitazone hydrochloride is an odorless white crystalline powder that has a
molecular formula of C19H20N2O3S•HCl and a molecular weight of 392.90 daltons.
It is soluble in N,N-dimethylformamide, slightly soluble in anhydrous
ethanol, very slightly soluble in acetone and acetonitrile, practically insoluble
in water, and insoluble in ether.
