ACTOS Tablet (2019)

Βιβλιογραφική αναφορά

Συγγραφείς

Takeda Pharmaceuticals America, Inc.

Λέξεις κλειδιά

64764-151 64764-301 64764-451

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1. Indications and Usage

Monotherapy and Combination Therapy ACTOS is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus in multiple clinical settings [see Clinical ...

2. Dosage and Administration

2.1 Recommendations for All Patients ACTOS should be taken once daily and can be taken without regard to meals. The recommended starting dose for patients without congestive heart failure is 15 mg or 30 ...

3. Dosage Forms and Strengths

Round tablet contains pioglitazone as follows: 15 mg: White to off-white, debossed with ACTOS on one side and 15 on the other. 30 mg: White to off-white, debossed with ACTOS on one side and 30 on the other. ...

4. Contraindications

Initiation in patients with established NYHA Class III or IV heart failure [see Boxed Warning]. Use in patients with known hypersensitivity to pioglitazone or any other component of ACTOS.

5. Warnings and Precautions

5.1 Congestive Heart Failure ACTOS, like other thiazolidinediones, can cause dose-related fluid retention when used alone or in combination with other antidiabetic medications and is most common when ACTOS ...

6. Adverse Reactions

The following serious adverse reactions are discussed elsewhere in the labeling: Congestive heart failure [see Boxed Warning and Warnings and Precautions (5.1)] Edema [see Warnings and Precautions ...

6.1. Clinical Trials Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another ...

6.2. Postmarketing Experience

The following adverse reactions have been identified during post-approval use of ACTOS. Because these reactions are reported voluntarily from a population of uncertain size, it is generally not possible ...

7. Drug Interactions

7.1 Strong CYP2C8 Inhibitors An inhibitor of CYP2C8 (e.g., gemfibrozil) significantly increases the exposure (area under the serum concentration-time curve or AUC) and half-life (t1/2) of pioglitazone. ...

8.1. Pregnancy

Risk Summary Limited data with ACTOS in pregnant women are not sufficient to determine a drug-associated risk for major birth defects or miscarriage. There are risks to the mother and fetus associated ...

8.2. Lactation

Risk Summary There is no information regarding the presence of pioglitazone in human milk, the effects on the breastfed infant, or the effects on milk production. Pioglitazone is present in rat milk; however ...

8.3. Females and Males of Reproductive Potential

Discuss the potential for unintended pregnancy with premenopausal women as therapy with ACTOS, like other thiazolidinediones, may result in ovulation in some anovulatory women.

8.4. Pediatric Use

Safety and effectiveness of ACTOS in pediatric patients have not been established. ACTOS is not recommended for use in pediatric patients based on adverse effects observed in adults, including fluid retention ...

8.5. Geriatric Use

A total of 92 patients (15.2%) treated with ACTOS in the three pooled 16- to 26-week double-blind, placebo-controlled, monotherapy trials were ≥65 years old and two patients (0.3%) were ≥75 years old. ...

10. Overdosage

During controlled clinical trials, one case of overdose with ACTOS was reported. A male patient took 120 mg per day for four days, then 180 mg per day for seven days. The patient denied any clinical symptoms ...

11. Description

ACTOS tablets are a thiazolidinedione and an agonist for peroxisome proliferator-activated receptor (PPAR) gamma that contains an oral antidiabetic medication: pioglitazone. Pioglitazone [(±)5[[4-[2-(5-ethyl-2-pyridinyl) ...

12.1. Mechanism of Action

ACTOS is a thiazolidinedione that depends on the presence of insulin for its mechanism of action. ACTOS decreases insulin resistance in the periphery and in the liver resulting in increased insulin-dependent ...

12.2. Pharmacodynamics

Clinical studies demonstrate that ACTOS improves insulin sensitivity in insulin-resistant patients. ACTOS enhances cellular responsiveness to insulin, increases insulin-dependent glucose disposal and improves ...

12.3. Pharmacokinetics

Following once-daily administration of ACTOS, steady-state serum concentrations of both pioglitazone and its major active metabolites, M-III (keto derivative of pioglitazone) and M-IV (hydroxyl derivative ...

13.1. Carcinogenesis, Mutagenesis, Impairment of Fertility

A two-year carcinogenicity study was conducted in male and female rats at oral doses up to 63 mg/kg (approximately 14 times the maximum recommended human oral dose of 45 mg based on mg/m²). Drug-induced ...

13.2. Animal Toxicology and/or Pharmacology

Heart enlargement has been observed in mice (100 mg/kg), rats (4 mg/kg and above) and dogs (3 mg/kg) treated orally with pioglitazone hydrochloride (approximately 11, 1, and 2 times the maximum recommended ...

14. Clinical Studies

14.1 Monotherapy Three randomized, double-blind, placebo-controlled trials with durations from 16 to 26 weeks were conducted to evaluate the use of ACTOS as monotherapy in patients with type 2 diabetes. ...

16.1. How Supplied

ACTOS is available in 15 mg, 30 mg, and 45 mg tablets as follows: 15 mg tablet: White to off-white, round, convex, nonscored tablet with ACTOS on one side, and 15 on the other, available in: NDC ...

16.2. Storage and Handling

Store at 25°C (77°F); excursions permitted to 15-30°C (59-86°F) [see USP Controlled Room Temperature]. Keep container tightly closed, and protect from light, moisture and humidity.

17. Patient Counseling Information

See FDA-Approved Patient Labeling (Medication Guide). It is important to instruct patients to adhere to dietary instructions and to have blood glucose and glycosylated hemoglobin tested regularly. During ...

BOXED WARNING SECTION

WARNING: CONGESTIVE HEART FAILURE Thiazolidinediones, including ACTOS, cause or exacerbate congestive heart failure in some patients [see Warnings and Precautions (5.1)]. After ...