ML91 Pill — WHITE ROUND, 10mm — Pioglitazone

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ImprintML91
ColourWHITE
ShapeROUND
Size10
StrengthPIOGLITAZONE HYDROCHLORIDE 45 mg
Dosage formTablet
ManufacturerMacleods Pharmaceuticals Limited
NDC33342-056
Schedule—
AvailabilityPrescription only
IngredientsPIOGLITAZONE HYDROCHLORIDE[PIOGLITAZONE]

What does this imprint mean?

The imprint "ML91" is a code stamped or printed on the tablet or capsule by the manufacturer, used to identify the drug, its strength and the maker.

Active ingredient

Pioglitazone

Uses and warnings

BOXED WARNING: "CONGESTIVE HEART FAILURE - Thiazolidinediones, including ACTOS, cause or exacerbate congestive heart failure in some patients." Patients should be observed for "signs and symptoms of heart failure (including excessive, rapid weight gain, dyspnea, and/or edema)," and "initiation of ACTOS in patients with established NYHA Class III or IV heart failure is contraindicated." Other key warnings include bladder cancer risk ("16/3656 (0.44%)" reports with pioglitazone vs. "5/3679 (0.14%)" without), increased bone fracture incidence in women (5.1% vs. 2.5% on placebo), and fluid retention that "may lead to or exacerbate heart failure."

ACTOS is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.

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Official references

Source: FDA Structured Product Label via NLM Pillbox archive (retired 2021); source file 3f073771-cbe1-4575-9f4c-44a6e5c1f90d.xml