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Actoplus MET

"The U.S. Food and Drug Administration today approved Tanzeum (albiglutide) subcutaneous injection to improve glycemic control, along with diet and exercise, in adults with type 2 diabetes.

Type 2 diabetes affects approximately 24 million pe"...

Actoplus MET, Actoplus MET XR

Actoplus MET, Actoplus MET XR

Actoplus MET Side Effects Center

Medical Editor: John P. Cunha, DO, FACOEP

Actoplus MET (pioglitazone hydrochloride and metformin hydrochloride) is for people with type 2 diabetes who do not use daily insulin injections. It is not for treating type 1 diabetes. Actoplus MET is a combination of 2 oral diabetes medicines. This medication is available in generic form. Common side effects include nausea, vomiting, stomach upset, diarrhea, weakness, sore throat, muscle pain, weight gain, tooth problems or a metallic taste in the mouth.

The dose of Actoplus MET is individualized on the basis of effectiveness and tolerability. The maximum recommended daily dose is pioglitazone 45 mg/metformin 2550 mg. Hyperglycemia (high blood sugar) may result if you take Actoplus MET with drugs that raise blood sugar, such as: isoniazid, diuretics (water pills), steroids, phenothiazines, thyroid medicine, birth control pills and other hormones, seizure medicines, and diet pills, or medicines to treat asthma, colds or allergies. Hypoglycemia (low blood sugar) may result if you take Actoplus MET with drugs that lower blood sugar, such as: alcohol, non-steroidal anti-inflammatory drugs (NSAIDs), aspirin or other salicylates, sulfa drugs, monoamine oxidase inhibitors (MAOIs), beta-blockers, or probenecid. It may also interact with furosemide, nifedipine, cimetidine or ranitidine, amiloride or triamterene, digoxin, morphine, procainamide, quinidine, trimethoprim, or vancomycin. Tell your doctor all medications you are taking. During pregnancy, Actoplus MET should be used only when prescribed. Your doctor may direct you to use insulin instead during your pregnancy. This medication can promote ovulation and increase the risk of becoming pregnant. Metformin passes into breast milk in small amounts. It is unknown if pioglitazone passes into breast milk. Consult your doctor before breast-feeding.

Our Actoplus MET (pioglitazone hydrochloride and metformin hydrochloride) Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What is Patient Information in Detail?

Easy-to-read and understand detailed drug information and pill images for the patient or caregiver from Cerner Multum.

Actoplus MET in Detail - Patient Information: Side Effects

This medication may cause lactic acidosis (a build-up of lactic acid in the body, which can be fatal). Lactic acidosis can start slowly and get worse over time. Get emergency medical help if you have even mild symptoms of lactic acidosis, such as: muscle pain or weakness, numb or cold feeling in your arms and legs, trouble breathing, stomach pain, nausea with vomiting, slow or irregular heart rate, dizziness, or feeling very weak or tired.

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have any other serious side effects, such as:

  • stomach pain, blood in your urine, painful urination;
  • feeling short of breath, especially when lying down;
  • swelling or rapid weight gain;
  • pale skin, feeling light-headed, rapid heart rate, trouble concentrating;
  • sudden unusual pain in your hand, arm, or foot; or
  • nausea, stomach pain, low fever, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes).

Less serious side effects may include:

  • headache;
  • diarrhea, upset stomach; or
  • sneezing, runny nose, cough or other signs of a cold.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Read the entire detailed patient monograph for Actoplus MET (Pioglitazone Hcl and Metformin Hcl) »

What is Patient Information Overview?

A concise overview of the drug for the patient or caregiver from First DataBank.

Actoplus MET Overview - Patient Information: Side Effects

SIDE EFFECTS: See also Warning section.

Nausea, vomiting, stomach upset, diarrhea, weakness, sore throat, muscle pain, weight gain, tooth problems or a metallic taste in the mouth may occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly. If stomach symptoms return later (after taking the same dose for several days or weeks), tell your doctor immediately. Stomach symptoms that occur after the first days of your treatment may be signs of lactic acidosis.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor right away if either of these serious side effects occurs: new/worsening vision problems (such as blurred vision), bone fracture, reddish-colored urine, urgent need to urinate, pain while urinating.

Pioglitazone may rarely cause liver disease. Tell your doctor right away if you develop symptoms of liver disease, including: dark urine, yellowing of eyes/skin, persistent nausea/vomiting, stomach/abdominal pain.

This medication usually does not cause low blood sugar (hypoglycemia). Low blood sugar may occur if this drug is prescribed with other anti-diabetic medications (such as insulin or a sulfonylurea). Low blood sugar is more likely if you drink large amounts of alcohol, do unusually heavy exercise, or do not consume enough calories from food. To help prevent low blood sugar, eat meals on a regular schedule, and do not skip meals. Check with your doctor or pharmacist to find out what you should do if you miss a meal.

Symptoms of low blood sugar include sudden sweating, shaking, fast heartbeat, hunger, blurred vision, dizziness, or tingling hands/feet. It is a good habit to carry glucose tablets or gel to treat low blood sugar. If you don't have these reliable forms of glucose, rapidly raise your blood sugar by eating a quick source of sugar such as table sugar, honey, or candy, or drink fruit juice or non-diet soda. Tell your doctor right away about the reaction and the use of this product.

Symptoms of high blood sugar (hyperglycemia) include thirst, increased urination, confusion, drowsiness, flushing, rapid breathing, or fruity breath odor. If these symptoms occur, tell your doctor right away. Your dosage may need to be increased.

A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any of the following symptoms of a serious allergic reaction: rash, itching/swelling (especially of the face/tongue/throat), dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Read the entire patient information overview for Actoplus MET (Pioglitazone Hcl and Metformin Hcl)»

What is Prescribing information?

The FDA package insert formatted in easy-to-find categories for health professionals and clinicians.

Actoplus MET FDA Prescribing Information: Side Effects
(Adverse Reactions)

SIDE EFFECTS

Over 8500 patients with type 2 diabetes have been treated with pioglitazone in randomized, double-blind, controlled clinical trials. This includes 2605 high-risk patients with type 2 diabetes treated with pioglitazone from the PROactive clinical trial. Over 6000 patients have been treated for 6 months or longer, and over 4500 patients for one year or longer. Over 3000 patients have received pioglitazone for at least 2 years.

The most common adverse events reported in at least 5% of patients in the controlled 16-week clinical trial between placebo plus metformin and pioglitazone 30 mg plus metformin were upper respiratory tract infection (15.6% and 15.5%), diarrhea (6.3% and 4.8%), combined edema/peripheral edema (2.5% and 6.0%) and headache (1.9% and 6.0%), respectively.

The incidence and type of adverse events reported in at least 5% of patients in any combined treatment group from the 24-week study comparing pioglitazone 30 mg plus metformin and pioglitazone 45 mg plus metformin are shown in Table 4; the rate of adverse events resulting in study discontinuation between the two treatment groups was 7.8% and 7.7%, respectively.

Table 4: Adverse Events That Occurred in ≥ 5% of Patients in Any Treatment Group During the 24-Week Study

Adverse Event
Preferred Term
Pioglitazone 30 mg + metformin
N=411 n (%)
Pioglitazone 45 mg + metformin
N=416 n (%)
Upper Respiratory Tract Infection 51 (12.4) 56 (13.5)
Diarrhea 24 (5.8) 20 (4.8)
Nausea 24 (5.8) 15 (3.6)
Headache 19 (4.6) 22 (5.3)
Urinary Tract Infection 24 (5.8) 22 (5.3)
Sinusitis 18 (4.4) 21 (5.0)
Dizziness 22 (5.4) 20 (4.8)
Edema Lower Limb 12 (2.9) 47 (11.3)
Weight Increased 12 (2.9) 28 (6.7)

Most clinical adverse events were similar between groups treated with pioglitazone in combination with metformin and those treated with pioglitazone monotherapy. Other adverse events reported in at least 5% of patients in controlled clinical trials between placebo and pioglitazone monotherapy included myalgia (2.7% and 5.4%), tooth disorder (2.3% and 5.3%), diabetes mellitus aggravated (8.1% and 5.1%) and pharyngitis (0.8% and 5.1%), respectively.

In U.S. double-blind studies, anemia was reported in ≤ 2% of patients treated with pioglitazone plus metformin (see PRECAUTIONS, General: Pioglitazone hydrochloride).

In monotherapy studies, edema was reported for 4.8% (with doses from 7.5 mg to 45 mg) of patients treated with pioglitazone versus 1.2% of placebo-treated patients. Most of these events were considered mild or moderate in intensity (see PRECAUTIONS, General: Pioglitazone hydrochloride).

Prospective Pioglitazone Clinical Trial In Macrovascular Events (PROactive)

In PROactive, 5238 patients with type 2 diabetes and a prior history of macrovascular disease were treated with ACTOS (n=2605), force-titrated up to 45 mg daily, or placebo (n=2633), in addition to standard of care. Almost all subjects (95%) were receiving cardiovascular medications (beta blockers, ACE inhibitors, ARBs, calcium channel blockers, nitrates, diuretics, aspirin, statins, fibrates). Patients had a mean age of 61.8 years, mean duration of diabetes 9.5 years, and mean A1C 8.1%. Average duration of follow-up was 34.5 months. The primary objective of this trial was to examine the effect of ACTOS on mortality and macrovascular morbidity in patients with type 2 diabetes mellitus who were at high risk for macrovascular events. The primary efficacy variable was the time to the first occurrence of any event in the cardiovascular composite endpoint (see table 5 below). Although there was no statistically significant difference between ACTOS and placebo for the 3-year incidence of a first event within this composite, there was no increase in mortality or in total macrovascular events with ACTOS.

Table 5: Number of First and Total Events for Each Component within the Cardiovascular Composite Endpoint

Cardiovascular Events Placebo
N=2633
ACTOS
N=2605
First Events (N) Total events (N) First Events (N) Total events (N)
Any event 572 900 514 803
All-cause mortality 122 186 110 177
Non-fatal MI 118 157 105 131
Stroke 96 119 76 92
ACS 63 78 42 65
Cardiac intervention 101 240 101 195
(Major leg amputation 15 28 9 28
Leg revascularization 57 92 71 115

Postmarketing reports of new onset or worsening diabetic macular edema with decreased visual acuity have also been received (see PRECAUTIONS, General: Pioglitazone hydrochloride).

Laboratory Abnormalities

Hematologic: Pioglitazone may cause decreases in hemoglobin and hematocrit. The fall in hemoglobin and hematocrit with pioglitazone appears to be dose related. Across all clinical studies, mean hemoglobin values declined by 2% to 4% in patients treated with pioglitazone. These changes generally occurred within the first 4 to 12 weeks of therapy and remained relatively stable thereafter. These changes may be related to increased plasma volume associated with pioglitazone therapy and have rarely been associated with any significant hematologic clinical effects (see PRECAUTIONS, General: Pioglitazone hydrochloride).

In controlled clinical trials of metformin at 29 weeks' duration, a decrease to subnormal levels of previously normal serum vitamin B12 levels, without clinical manifestations, was observed in approximately 7% of patients. Such decrease, possibly due to interference with B12 absorption from the B12 -intrinsic factor complex, is, however, very rarely associated with anemia and appears to be rapidly reversible with discontinuation of metformin or vitamin B12 supplementation (see PRECAUTIONS, General: Metformin hydrochloride).

Serum Transaminase Levels: During all clinical studies in the U.S., 14 of 4780 (0.30%) patients treated with pioglitazone had ALT values ≥ 3 times the upper limit of normal during treatment. All patients with follow-up values had reversible elevations in ALT. In the population of patients treated with pioglitazone, mean values for bilirubin, AST, ALT, alkaline phosphatase, and GGT were decreased at the final visit compared with baseline. Fewer than 0.9% of patients treated with pioglitazone were withdrawn from clinical trials in the U.S. due to abnormal liver function tests.

In pre-approval clinical trials, there were no cases of idiosyncratic drug reactions leading to hepatic failure (see PRECAUTIONS, General: Pioglitazone hydrochloride).

CPK Levels: During required laboratory testing in clinical trials with pioglitazone, sporadic, transient elevations in creatine phosphokinase levels (CPK) were observed. An isolated elevation to greater than 10 times the upper limit of normal was noted in 9 patients (values of 2150 to 11400 IU/L). Six of these patients continued to receive pioglitazone, two patients had completed receiving study medication at the time of the elevated value and one patient discontinued study medication due to the elevation. These elevations resolved without any apparent clinical sequelae. The relationship of these events to pioglitazone therapy is unknown.

Read the entire FDA prescribing information for Actoplus MET (Pioglitazone Hcl and Metformin Hcl) »

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Actoplus MET, Actoplus MET XR - User Reviews

Actoplus MET, Actoplus MET XR User Reviews

Now you can gain knowledge and insight about a drug treatment with Patient Discussions.

Here is a collection of user reviews for the medication Actoplus MET, Actoplus MET XR sorted by most helpful. Patient Discussions FAQs

Report Problems to the Food and Drug Administration

 

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.


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