Actoplus MET, Actoplus MET XR Drug Description

ACTOPLUS MET® (pioglitazone hydrochloride and metformin hydrochloride) Sildigra tablets contain two oral antihyperglycemic drugs used in the management of type 2 diabetes: pioglitazone hydrochloride and metformin hydrochloride. The concomitant use of pioglitazone and metformin has been previously approved based on clinical trials in patients with type 2 diabetes inadequately controlled on metformin. Additional efficacy and safety information about pioglitazone and metformin monotherapies may be found in the prescribing information for each individual drug.

Pioglitazone hydrochloride is an oral antihyperglycemic agent that acts primarily by decreasing insulin resistance. Pioglitazone is used in the management of type 2 diabetes. Pharmacological studies indicate that pioglitazone improves sensitivity to insulin in muscle and adipose tissue and inhibits hepatic gluconeogenesis. Pioglitazone improves glycemic control while reducing circulating insulin levels.

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, biguanides, or the α-glucosidase inhibitors. The molecule contains one asymmetric center, and the synthetic compound is a racemate. The two enantiomers of pioglitazone interconvert in vivo. The structural formula is as shown:

Pioglitazone hydrochloride

Pioglitazone hydrochloride is an odorless white crystalline powder that has a molecular formula of C₁₉H₂₀N₂O₃S•HCl and a molecular weight of 392.90. 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 not chemically or pharmacologically related to any other classes of oral antihyperglycemic agents. Metformin 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

ACTOPLUS MET is available as a tablet for oral administration containing 15 mg pioglitazone hydrochloride (as the base) with 500 mg metformin hydrochloride (15 mg/500 mg) or 15 mg pioglitazone hydrochloride (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.

Actoplus Met Side Effects

Swelling, upper respiratory tract infections, and weight gain Zydalis are some of the more common Actoplus Met side effects. These are generally considered minor and do not require medical attention. However, you should contact your healthcare provider immediately if you develop serious side effects of Actoplus Met, such as chest pain, signs of low blood sugar, vision changes, or an allergic reaction.

Actoplus Met Side Effects: An Introduction

As with any medicine, side effects are possible with Actoplus Met^® (pioglitazone and metformin). However, not everyone who takes the drug will experience side effects. In fact, most people tolerate it quite well. If side effects do occur, in most cases, they are minor and either require no treatment or can be easily treated by you or your healthcare provider.

 

(This article covers many, but not all, of the possible side effects with Actoplus Met. Your healthcare provider can discuss a more complete list of Actoplus Met side effects with you.)

 

Common Side Effects of Actoplus Met

Actoplus Met has been studied thoroughly in clinical trials in which side effects of a group of people taking the drug are documented and compared to another group not taking the medicine.

This way, it is possible to see what side effects occur, how often they appear, and how they compare to the group not taking the medicine.

 

Based on these studies, the most common Actoplus Met side effects include:

 

• Upper respiratory tract infections (similar to thecommon cold or flu) -- in up to 13.5 percent of people
• Swelling or fluid retention (edema) of the lower leg or ankles -- up to 11.3 percent
• Weight gain -- up to 6.7 percent (see Actoplus Met and Weight Gain)
• Diarrhea -- up to 5.8 percent
• Nausea -- up to 5.8 percent
• Urinary tract infections (UTI), including bladder infections -- up to 5.8 percent
• Dizziness -- up to 5.4 percent
• Headache -- up to 5.3 percent
• Sinus infection or irritation -- up to 5 percent.