Loading…
AG-PIOGLITAZONE is a brand name for Pioglitazone, supplied as a tablet. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: AND CLINICAL USE ..................................................................................... 3 CONTRAINDICATIONS .......................................................................................................... 4 WARNINGS AND…
Verbatim from this product's HC label. Tap a section to expand.
Adverse Drug Reaction Overview In worldwide clinical trials, over 3700 patients with type 2 diabetes have been treated with pioglitazone hydrochloride. For most clinical adverse events the incidence was similar for groups treated with pioglitazone hydrochloride monotherapy.
5 mg, 15 mg, 30 mg, or 45 mg once daily are shown in Table 1. Table 1. 2% on placebo. 0% has been reported with pioglitazone hydrochloride. 5% on placebo. 2% on placebo. 2% of patients on pioglitazone hydrochloride monotherapy compared to none on placebo.
5% in excess of placebo in double-blind placebo-controlled studies for pioglitazone hydrochloride monotherapy were: visual disturbance, upper respiratory tract infection, weight increased and hypoaesthesia. 3%). Weight gain was observed in all clinical trials, including two patients withdrawn due to excessive weight gain.
(see ACTION AND CLINICAL PHARMACOLOGY – Pharmacodynamics, and WARNINGS AND PRECAUTIONS). AG-Pioglitazone 9 Abnormal Hematologic and Clinical Chemistry Findings Hematologic: Across all clinical studies, mean hemoglobin values declined by 2% to 4% in pioglitazone hydrochloride -treated patients.
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 hydrochloride therapy and have not been associated with any significant hematologic clinical effects.
Values remained within normal limits at all times (including up to 18 months of continuous therapy).
CPK Levels:
During required laboratory testing in clinical trials, 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 hydrochloride, 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 hydrochloride therapy is unknown. 25%) placebo-treated patients had ALT values ≥3 times the upper limit of normal in double-blind, randomized clinical trials. 43%) pioglitazone hydrochloride-treated patients had ALT values ≥3 times the upper limit of normal.
AG-Pioglitazone (pioglitazone hydrochloride) are contraindicated in: • New York Heart Association (NYHA) Class I to IV cardiac status. • known hypersensitivity to this drug or any of its components; • serious hepatic impairment (see WARNINGS AND PRECAUTIONS, Hepatic); • pregnancy.
Insulin is recommended during pregnancy to control blood glucose levels. Oral antidiabetic agents should not be given (see WARNINGS AND PRECAUTIONS, Special Populations, Pregnant Women). WARNINGS AND PRECAUTIONS General The effect of AG-Pioglitazone (pioglitazone hydrochloride) on morbidity and mortality has not been established.
AG-Pioglitazone exerts its antihyperglycemic effect only in the presence of insulin. Therefore, AG-Pioglitazone should not be used in patients with type 1 diabetes or for the treatment of diabetic ketoacidosis. The use of AG-Pioglitazone in combination with insulin is not indicated (See CLINICAL TRIALS).
The use of pioglitazone hydrochloride in combination with metformin AND/OR a sulfonylurea (triple therapy) is not indicated.
Weight Gain:
AG-Pioglitazone may be associated with weight gain. 8 kg. Treatment should be re-evaluated in patients with excessive weight gain (see ACTION AND CLINICAL PHARMACOLOGY, Pharmacodynamics). 7%). The majority of these fractures were in the distal upper limb or distal lower limb.
The risk of fracture should be considered in the case of female patients treated with Pioglitazone Hydrochloride Tablets, and attention given to assessing and maintaining bone health according to current standards of care. Carcinogenesis and Mutagenesis See PART II, TOXICOLOGY, for animal studies.
Cardiovascular Congestive Heart Failure:
Thiazolidinediones, like Pioglitazone Hydrochloride Tablets, can cause fluid retention, which can lead to congestive heart failure. The fluid retention may very rarely present as rapid and excessive weight gain. All patients should be monitored for signs and AG-Pioglitazone 5 symptoms of adverse reactions relating to fluid retention and heart failure.
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
Other brands of Pioglitazone in Canada.
Know a brand we are missing in Canada? Suggest a brand →
Brand names are compiled from public regulatory records for active-ingredient mapping only. Drugvu is not affiliated with any manufacturer. This is not medical advice.
All patients with follow-up values had reversible elevations in ALT. In the population of patients treated with pioglitazone hydrochloride, mean values for bilirubin, AST, ALT, alkaline phosphatase, and GGT were decreased at the final visit compared with baseline.
12% of pioglitazone hydrochloride-treated patients were withdrawn from clinical trials due to abnormal liver function tests. In pre-approval clinical trials, there were no cases of idiosyncratic drug reactions leading to hepatic failure.
Post-Marketing Adverse Drug Reactions Findings from post-market experience with Pioglitazone hydrochloride are reported below, including spontaneously reported adverse drug reactions. Because the latter are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or clearly establish a causal relationship to Pioglitazone hydrochloride exposure.
In post-marketing experience with pioglitazone hydrochloride, cases of congestive heart failure and pulmonary edema have been reported. Cases of hepatitis and of hepatic enzyme elevations to 3 or more times the upper limit of normal have been received.
Very rarely, these reports have involved hepatic failure with and without fatal outcome, although causality has not been established. Postmarketing reports of new onset or worsening (diabetic) macular edema with decreased visual acuity have been reported rarely with the use of pioglitazone as monotherapy or in combination therapy.
Affected patients also frequently reported concurrent peripheral edema. In some cases, symptoms improved following discontinuation of pioglitazone. 7%). The majority of these fractures were in the distal upper limb or distal lower limb.
Postmarketing reports of bladder cancer have been reported very rarely […]
In particular, patients who are at risk for heart failure including those receiving concurrent therapy which increases insulin levels should be closely monitored (see ADVERSE REACTIONS). Treatment with thiazolidinediones, like Pioglitazone Hydrochloride Tablets, has been associated with cases of congestive heart failure, some of which were difficult to treat unless the medication was discontinued.
AG-Pioglitazone should be discontinued if any deterioration in cardiac status occurs. Since patients experiencing acute coronary syndrome (ACS) are at increased risk of developing heart failure, and in view of the potential for pioglitazone to cause or exacerbate heart failure, initiation of pioglitazone in patients experiencing an acute coronary event is not recommended.
Furthermore, discontinuation of pioglitazone during the acute phase should be considered. AG-Pioglitazone are contraindicated in patients with NYHA Class I, II, III, and IV heart failure. Patients with severe heart failure (including NYHA Class III and IV cardiac status) were not studied during clinical trials (see CLINICAL TRIALS).
Edema:
AG-Pioglitazone should be used with caution in patients with edema. In placebo- controlled clinical studies, the incidence of edema is increased with pioglitazone hydrochloride relative to the control groups and may be dose-related (See ADVERSE REACTIONS).
For information on macular edema, see WARNINGS AND PRECAUTIONS, Ophthalmologic.
Endocrine and Metabolism Hypoglycemia:
During the administration of pioglitazone hydrochloride as monotherapy, documented hypoglycemia has not been observed, nor would it be expected based on the mechanism of action. Hematologic Across all clinical studies, mean hemoglobin values declined by 2% to 4% in pioglitazone hydrochloride-treated patients but remained within normal limits at all times (including up to 18 months of continuous therapy).
In all studies, patients were excluded if they had a hemoglobin of less than 120 g/L for males or 100 g/L for females. In the monotherapy studies, the mean hemoglobin declined from 151 to 147 g/L, with the range in the bottom 10% of hemoglobin values 111 to 125 g/L.
In a long-term, open-label follow-up monotherapy study of an additional 84 weeks, the change in hemoglobin remained small, declining from 151 to 143 g/L. The changes may be related to increased plasma volume and have not been associated with any significant hematologic clinical effects (see ADVERSE REACTIONS, Laboratory Abnormalities).
Hepatic Rare cases of severe hepatocellular injury have been reported associated with thiazolidinediones. 5 times the upper limit of normal). Although available data from clinical studies show no evidence of pioglitazone hydrochloride- AG-Pioglitazone 6 induced hepatotoxicity or ALT elevations, pioglitazone has a common thiazolidinedione structure to troglitazone, which has been associated with idiosyncratic hepatotoxicity and rare cases of liver failure, liver transplants, and death.
In post-marketing experience with pioglitazone hydrochloride, reports of hepatitis, hepatic enzyme elevations 3 or more times the upper limit of normal, and hepatic failure with and without fatal outcome have been received. It is recommended that patients treated with AG-Pioglitazone undergo periodic monitoring of liver enzymes.
Liver enzymes should be checked prior to the initiation of therapy with AG-Pioglitazone in all patients. In patients with normal baseline liver enzymes, following initiation of therapy with […]