March 30, 2017
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Actoplus MET

"NEW YORK (Reuters Health) - Taking glucagon-like peptide 1 (GLP-1) analogues is associated with an increased risk of bile duct and gallbladder disease, but not pancreatitis, in people with type 2 diabetes, according to two new studies.

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Actoplus MET, Actoplus MET XR

ACTOPLUS MET
(pioglitazone and metformin hydrochloride) Tablets




WARNING

CONGESTIVE HEART FAILURE AND LACTIC ACIDOSIS

Congestive Heart Failure

  • Thiazolidinediones, including pioglitazone, which is a component of ACTOPLUS MET, cause or exacerbate congestive heart failure in some patients [see WARNINGS AND PRECAUTIONS].
  • After initiation of ACTOPLUS MET, and after dose increases, monitor patients carefully for signs and symptoms of heart failure (e.g., excessive, rapid weight gain, dyspnea, and/or edema). If heart failure develops, it should be managed according to current standards of care and discontinuation or dose reduction of ACTOPLUS MET must be considered [see WARNINGS AND PRECAUTIONS].
  • ACTOPLUS MET is not recommended in patients with symptomatic heart failure.
  • Initiation of ACTOPLUS MET in patients with established New York Heart Association (NYHA) Class III or IV heart failure is contraindicated [see CONTRAINDICATIONS and WARNINGS AND PRECAUTIONS].

Lactic Acidosis

  • Lactic acidosis is a rare but serious complication that can occur due to metformin accumulation. The risk increases with conditions such as sepsis, dehydration, excess alcohol intake, hepatic impairment, renal impairment, and acute congestive heart failure [see WARNINGS AND PRECAUTIONS].
  • The onset is often subtle, accompanied only by nonspecific symptoms such as malaise, myalgias, respiratory distress, increasing somnolence, and nonspecific abdominal distress. Laboratory abnormalities include low pH, increased anion gap, and elevated blood lactate [see WARNINGS AND PRECAUTIONS].
  • If acidosis is suspected, ACTOPLUS MET should be discontinued and the patient hospitalized immediately [see WARNINGS AND PRECAUTIONS].

DRUG DESCRIPTION

ACTOPLUS MET tablets are a thiazolidinediones and biguanide combination product that contains two oral antidiabetic medications: pioglitazone hydrochloride and metformin hydrochloride.

Pioglitazone [(±)-5-[[4-[2-(5-ethyl-2-pyridinyl) ethoxy]phenyl]methyl]-2,4-] thiazolidinedione monohydrochloride 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. The structural formula is as shown:

Pioglitazone hydrochloride - Structural Formula Illustration

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.

Metformin hydrochloride (N,N-dimethylimidodicarbonimidic diamide hydrochloride) is a white crystalline powder with a molecular formula of C4H11N5•HCl and a molecular weight of 165.62. Metformin hydrochloride is freely soluble in water and is practically insoluble in acetone, ether, and chloroform. The pKa of metformin is 12.4. The pH of a 1% aqueous solution of metformin hydrochloride is 6.68. The structural formula is as shown:

Metformin hydrochloride - Structural Formula Illustration

ACTOPLUS MET is available as a tablet for oral administration containing 15 mg pioglitazone (as the base) with 500 mg metformin hydrochloride (15 mg/500 mg) or 15 mg pioglitazone (as the base) with 850 mg metformin hydrochloride (15 mg/850 mg) formulated with the following excipients: povidone USP, microcrystalline cellulose NF, croscarmellose sodium NF, magnesium stearate NF, hypromellose 2910 USP, polyethylene glycol 8000 NF, titanium dioxide USP, and talc USP.

What are the possible side effects of metformin and pioglitazone (Actoplus Met, Actoplus Met XR)?

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;...

Read All Potential Side Effects and See Pictures of Actoplus MET, Actoplus MET XR »

What are the precautions when taking pioglitazone hcl and metformin hcl (Actoplus MET, Actoplus MET XR)?

See also Warning section.

Before taking this medication, tell your doctor or pharmacist if you are allergic to pioglitazone or metformin; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: severe breathing problems (such as obstructive lung disease, severe asthma), blood problems (such as anemia, vitamin B12 deficiency), kidney disease, liver disease, heart disease (such as congestive heart failure, chest pain), fluid in your lungs, swelling (edema), a certain eye problem (macular edema), bladder cancer.

Before having surgery or any...

Read All Potential Precautions of Actoplus MET, Actoplus MET XR »

Last reviewed on RxList: 12/28/2016
This monograph has been modified to include the generic and brand name in many instances.

Actoplus MET, Actoplus MET XR - User Reviews

Actoplus MET, Actoplus MET XR User Reviews

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