Actoplus Met XR Dosage

Generic name: pioglitazone hydrochloride and metformin hydrochloride
Dosage form: tablet, film coated, extended release

See also:

This dosage information does not include all the information needed to use Actoplus Met XR safely and effectively. See full prescribing information for Actoplus Met XR.

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General

The use of ACTOPLUS MET or ACTOPLUS MET XR in the management of type 2 diabetes should be individualized on the basis of effectiveness and tolerability.

The starting doses of ACTOPLUS MET or ACTOPLUS MET XR should be based on the patient's current regimen of pioglitazone and/or metformin and the starting doses of these two drugs. The usual starting dose of pioglitazone is 15 to 30 mg daily. The usual starting dose of metformin is 850 to 1000 mg daily.
To reduce the gastrointestinal side effects associated with metformin, ACTOPLUS MET and ACTOPLUS MET XR should be administered with a meal.
After initiation of ACTOPLUS MET or ACTOPLUS MET XR or with dose increase, patients should be carefully monitored for adverse events related to fluid retention (see BOXED WARNING and WARNINGS, Pioglitazone).
The dosage of ACTOPLUS MET or ACTOPLUS MET XR should be gradually titrated, as needed, based on the adequacy of the therapeutic response.
The total daily doses of ACTOPLUS MET or ACTOPLUS MET XR should not exceed the maximum recommended total daily doses of pioglitazone (45 mg) or metformin (2550 mg for immediate-release metformin and 2000 mg for extended-release metformin).

No studies have been performed specifically examining the safety and efficacy of ACTOPLUS MET or ACTOPLUS MET XR in patients previously treated with other oral hypoglycemic agents and switched to ACTOPLUS MET or ACTOPLUS MET XR. Any change in therapy of type 2 diabetes should be undertaken with care and appropriate monitoring as changes in glycemic control can occur.

Sufficient time should be given to assess adequacy of therapeutic response. Ideally, the response to therapy should be evaluated using HbA1c, which is a better indicator of long-term glycemic control than FPG alone. HbA1c reflects glycemia over the past two to three months. In clinical use, it is recommended that patients be treated with ACTOPLUS MET or ACTOPLUS MET XR for a period of time adequate to evaluate change in HbA1c (8 to 12 weeks) unless glycemic control as measured by FPG deteriorates.

Dosage Recommendations

The dosage recommendations for ACTOPLUS MET and ACTOPLUS MET XR are summarized in Table 8.

Table 8. ACTOPLUS MET and ACTOPLUS MET XR Dosage Recommendations

ACTOPLUS MET

ACTOPLUS MET XR

Pioglitazone/immediate-release metformin hydrochloride

Pioglitazone/extended-release metformin hydrochloride

 

Tablet strengths

15 mg/500 mg
15 mg/850 mg

15 mg/1000 mg
30 mg/1000 mg

Starting Dose

15 mg/500 mg or 15 mg/850 mg tablets once or twice daily with food

15 mg/1000 mg or 30 mg/1000 mg tablets once daily with evening meal

Maximum Recommended Daily Dose

45 mg/2550 mg administered in divided doses with food

45 mg/2000 mg administered once daily with evening meal

ACTOPLUS MET

The usual starting dose of ACTOPLUS MET is 15 mg/500 mg or 15 mg/850 mg tablet strength of pioglitazone/immediate-release metformin administered once or twice daily with food to reduce the gastrointestinal side effects associated with metformin.

The maximal total daily dose of ACTOPLUS MET is 45 mg/2550 mg of pioglitazone/immediate-release metformin. This maximal dosage should be administered in divided doses with meals.

ACTOPLUS MET XR

The usual starting dose of ACTOPLUS MET XR is 15 mg/1000 mg or 30 mg/1000 mg tablet strength of pioglitazone/extended-release metformin administered once daily with the evening meal.

The maximal total daily dose of ACTOPLUS MET XR is 45 mg/2000 mg of pioglitazone/extended-release metformin administered once daily with the evening meal.

Patients should be informed that ACTOPLUS MET XR must be swallowed whole and not chewed, cut or crushed, and that the inactive ingredients may occasionally be eliminated in the feces as a soft mass that may resemble the original tablet.

Special Patient Populations

Pregnancy

ACTOPLUS MET and ACTOPLUS MET XR are not recommended for use during pregnancy or in breastfeeding women.

Geriatric

The initial and maintenance dosing of ACTOPLUS MET or ACTOPLUS MET XR should be conservative in patients with advanced age, due to the potential for decreased renal function in this population. Any dosage adjustment should be based on a careful assessment of renal function. Generally, elderly, debilitated and malnourished patients should not be titrated to the maximum dose of ACTOPLUS MET or ACTOPLUS MET XR. Monitoring of renal function is necessary to aid in prevention of metformin-associated lactic acidosis, particularly in the elderly (see WARNINGS, Metformin Hydrochloride and PRECAUTIONS, General, Metformin Hydrochloride).

Renal Impairment

Metformin is substantially excreted by the kidney. ACTOPLUS MET and ACTOPLUS MET XR should only be used in patients with normal renal function (see CONTRAINDICATIONS, WARNINGS, Metformin Hydrochloride, PRECAUTIONS and CLINICAL PHARMACOLOGY, Special Populations). Any dosage adjustment in ACTOPLUS MET or ACTOPLUS MET XR should be based on a careful assessment of renal function.

Hepatic Impairment

Therapy with ACTOPLUS MET or ACTOPLUS MET XR should not be initiated if the patient exhibits clinical evidence of active liver disease or increased serum transaminase levels (ALT greater than 2.5 times the upper limit of normal) at start of therapy (see PRECAUTIONS, General, Pioglitazone and CLINICAL PHARMACOLOGY, Special Populations, Hepatic Insufficiency). Liver enzyme monitoring is recommended in all patients prior to initiation of therapy with ACTOPLUS MET or ACTOPLUS MET XR and periodically thereafter (see PRECAUTIONS, General, Pioglitazone and PRECAUTIONS, Laboratory Tests).

Pediatric

Use in pediatric patients is not recommended for the treatment of diabetes due to lack of long-term safety data. Risks, including fractures and other adverse effects associated with pioglitazone, one of the components of ACTOPLUS MET and ACTOPLUS MET XR, have not been determined in this population (see WARNINGS and PRECAUTIONS).

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