Medicinal Products

ACTOS 15 mg

Generic drug of the therapeutic class: Metabolism and nutrition
active ingredients: Pioglitazone
laboratory: Takeda Europe RD Center

Compressed
Box of 84
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Indication

Pioglitazone is indicated for the treatment of patients with type 2 diabetes:
- As monotherapy:
in the patient particularly overweight, insufficiently controlled by diet or exercise and in whom metformin is contraindicated or not tolerated.
- Oral dual therapy in combination with:
. metformin, in particularly overweight patients, when a maximum tolerated dose of oral monotherapy with metformin does not provide sufficient glycemic control.
. a sulphonylurea, only in patients who are intolerant to metformin or for whom metformin is contraindicated, when a maximum tolerated dose of oral monotherapy with sulphonylurea does not provide sufficient glycemic control.
- In triple oral association with:
metformin and a sulphonylurea hypoglycemic in patients, particularly overweight, in which the combination therapy combinations above do not provide sufficient glycemic control.
- Pioglitazone is also indicated in combination with insulin in patients with type 2 diabetes who are insufficiently controlled by insulin and for whom metformin is contraindicated or poorly tolerated (see section cautionary statements and precautions for use).

Dosage ACTOS 15 mg Tablet Box of 84

- Pioglitazone is administered orally once daily during or after meals.
- Treatment with pioglitazone can be initiated at 15 mg or 30 mg once daily. The dose may be increased gradually to 45 mg once daily.
- In combination with insulin, the insulin dose may be maintained during initiation of pioglitazone therapy. In case of hypoglycemia, the insulin dose should be decreased.
- Elderly:
No dose adjustment is necessary in elderly patients (see section 5.2).
- Inadequate renal:
No dose adjustment is required in patients with renal impairment (creatinine clearance> 4 ml / min) (see section 5.2). Pioglitazone should not be administered in dialysis patients as no information is available in this population.
- Hepatic insufficiency:
Pioglitazone should not be used in patients with hepatic insufficiency (see Warnings and Precautions section).
- Child and teenager:
In the absence of available data, the use of pioglitazone is not recommended in subjects under 18 years of age.

Against indications

CONTRAINDICATED:
- Pioglitazone is contraindicated in patients with:
. hypersensitivity to the active substance or to any of the excipients,
. heart failure or a history of heart failure (NYHA stage I to IV),
. hepatic insufficiency,
. diabetic ketoacidosis.
- Pioglitazone should not be administered in dialysis patients as no information is available in this population.
- Pregnancy: In humans, there are no adequate data to assess the safety of pioglitazone during pregnancy. In animals, toxicity studies have shown a decrease in fetal growth in exposed fetuses. This toxicity is attributed to the action of pioglitazone, which decreases maternal hyperinsulinemia and insulin resistance during pregnancy, thus reducing the use of metabolic substrates during fetal growth. The potential risk of such a phenomenon is not known in women. Pioglitazone should not be used during pregnancy.
- Breast-feeding: in animals (spleen), pioglitazone was detected in milk. In the absence of data on the use of pioglitazone in human milk, pioglitazone should not be used in women who are breastfeeding.
- If a patient wants a pregnancy or if a pregnancy occurs, the treatment should be stopped (see paragraph pregnancy and lactation).
- Due to the presence of lactose monohydrate, ACTOS tablets should not be used in patients with rare hereditary problems of galactose intolerance, lactase deficiency or malabsorption of glucose and galactose.
NOT RECOMMENDED :
Child and adolescent: In the absence of available data, the use of pioglitazone is not recommended in subjects younger than 18 years of age.

Adverse effects Actos

Adverse reactions reported at a frequency greater than 0.5% compared with placebo and greater than an isolated case in patients receiving pioglitazone in double-blind studies are listed below according to the MedDRA classification (by class of organ and absolute frequency). The frequencies are defined as follows: very common> 1/10, frequent> 1/100 and 1/1000 and 1/10000 and <1/1000; very rare <1/10000; unknown (can not be estimated from the available data). Within each frequency group, adverse effects are presented in order of decreasing severity.
PIOGLITAZONE IN MONOTHERAPY :
- Eye disorders:
Frequent : visual disturbances.
- Infectious disorders:
. Common : high respiratory infection
. Uncommon : sinusitis.
- Clinical and paraclinical examinations:
Frequent : weight gain
- Nervous system disorders:
. Frequent : hypoesthesia
. Uncommon : insomnia.
PIOGLITAZONE IN ASSOCIATION WITH METFORMIN :
- Blood and lymphatic system disorders:
Frequent : anemia.
- Eye disorders:
Frequent : visual disturbances.
- Gastrointestinal disorders:
Uncommon : flatulence.
- Clinical and paraclinical examinations:
Frequent : weight gain
- Musculoskeletal system and connective tissue disorders:
Common : arthralgia
- Nervous system disorders:
Frequent : headache.
- Renal and urinary disorders:
Frequent : hematuria.
- Reproductive system and breast disorders:
Frequent : erectile dysfunction.
PIOGLITAZONE IN ASSOCIATION WITH A HYPOGLYCEMIC SULFAMIDE :
- Ear and ear disorders:
Uncommon : dizziness.
- Eye disorders:
Uncommon : visual disturbances.
- Gastrointestinal disorders:
Frequent : flatulence.
- General and localized disorders at the site of administration:
Uncommon : tiredness
- Clinical and paraclinical examinations:
. Frequent : weight gain
. Uncommon : increased lactate dehydrogenase.
- Metabolism and nutrition disorders:
Uncommon : increased appetite, hypoglycaemia.
- Nervous system disorders:
. Common : Stunning
. Uncommon : headache.
- Renal and urinary disorders:
Uncommon : glycosuria, proteinuria.
- Skin and subcutaneous disorders:
Uncommon : Sweating
PIOGLITAZONE IN ASSOCIATION TRIPLE WITH METFORMIN AND A HYPOGLYCEMIC SULFAMIDE :
- Clinical and paraclinical examinations:
Frequent : weight gain, increased blood creatine phosphokinase.
- Metabolism and nutrition disorders:
Very common : hypoglycaemia.
- Musculoskeletal system and connective tissue disorders:
Common : arthralgia
PIOGLITAZONE IN ASSOCIATION WITH INSULIN :
- Metabolism and nutrition disorders:
Frequent : hypoglycemia.
- General and localized disorders at the site of administration:
Very common : edema.
- Infectious disorders:
Frequent : bronchitis.
- Clinical and paraclinical examinations:
Frequent : weight gain
- Musculoskeletal system and connective tissue disorders:
Frequent : backache, arthralgia.
- Respiratory, thoracic, and mediastinal disorders:
Common : dyspnoea
- Cardiac disorders:
Common : heart failure.
DATA AFTER MARKETING :
Eye disorders:
Not known : macular edema.
- Edema has been reported in 6-9% of patients who received pioglitazone for more than one year in controlled clinical trials. The rate of edema in the comparator groups (hypoglycemic sulfonamides, metformin) was 2-5%. The edema was usually mild to moderate, not requiring discontinuation of treatment.
- In controlled and comparative clinical trials with pioglitazone monotherapy, mean weight gain was 2 to 3 kg after 1 year. This is identical to that observed with the sulfonylurea hypoglycemic comparator group. In the pioglitazone-associated comparator trials, mean weight gain after one year was 1.5 kg and, in the case of combination with the sulphonylurea, 2.8 kg. In the comparator groups, the addition of sulfonylurea to metformin resulted in an average weight gain of 1.3 kg and the addition of metformin to a hypoglycemic sulfonamide at an average weight loss of 1.0 kg.
- Visual disturbances have been reported particularly at the beginning of treatment. They are related to the change in blood glucose that is responsible for a temporary alteration of the turgor and refractive index of the lens as seen with other hypoglycemic agents.
- In clinical studies with pioglitazone, the incidence of an increase in ALAT greater than 3 times the upper limit of normal was equivalent to that of placebo but lower than that observed in the metformin comparator or sulphonylurea groups. The mean level of liver enzymes was reduced during treatment with pioglitazone. Rare cases of elevated liver enzymes and hepatocellular dysfunction have been reported post-marketing. Although in very rare cases a fatal evolution has been reported no causal relationship has been established.
- In controlled clinical trials, the incidence of cardiac insufficiency reported with pioglitazone was similar to that of placebo, metformin and sulphonylurea, but was increased when pioglitazone was used in combination with insulin. In a study of cardiovascular morbidity and mortality in patients with pre-existing major macrovascular disease, the incidence of severe heart failure, when pioglitazone was added to a treatment with insulin, was 1.6%. higher than the placebo group. However, this did not lead to an increase in mortality in the study. Rare cases of heart failure have been reported since pioglitazone was marketed, but more frequently when pioglitazone was used in combination with insulin. in patients with a history of heart failure.
- Data from double-blind randomized controlled clinical trials versus comparators (placebo or active comparator), involving more than 8, 100 pioglitazone-treated patients and more than 7, 400 comparator-treated patients up to 3.5 years of age have been analyzed. A higher rate of fractures was observed in women treated with pioglitazone (2.6%) compared to those treated with a comparator (1.7%). No increase in fracture rate was observed in men treated with pioglitazone (1.3%) versus a comparator (1.5%).
- In the PROactive study, a 3.5-year cardiovascular morbidity-mortality study, 44/870 (5.1%) of patients treated with pioglitazone developed fractures compared to 23/905 (2.5%) patients treated by a comparator. No increase in fracture rates was observed in men treated with pioglitazone (1.7%) versus comparator (2.1%).

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