Actos


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pioglitazone hydrochloride

Actos, Apo-Pioglitazone (CA), Co Pioglitazone (CA), Gen-Pioglitazone (CA), Novo-Pioglitazone (CA), PMS-Pioglitazone (CA), Ratio-Pioglitazone (CA), Sandoz Pioglitazone (CA)

Pharmacologic class: Thiazolidinedione

Therapeutic class: Hypoglycemic

Pregnancy risk category C

FDA Box Warning

• Drug may cause or exacerbate heart failure. After starting therapy or increasing dosage, observe patient carefully for signs and symptoms of heart failure. If these develop, manage patient according to current standards of care and consider discontinuing drug or reducing dosage.

• Drug isn't recommended in patients with symptomatic heart failure. In patients with established New York Heart Association Class III or IV heart failure, drug initiation is contraindicated.

Action

Enhances insulin sensitivity in muscle and adipose tissue; inhibits hepatic gluconeogenesis

Availability

Tablets: 15 mg, 30 mg, 45 mg

Indications and dosages

Adjunct to diet and exercise to improve glycemic control in type 2 (non-insulin-dependent) diabetes mellitus

Adults: 15 to 30 mg/day; may increase to 45 mg/day if needed

Contraindications

• Hypersensitivity to drug, its components, or rosiglitazone
• Established New York Heart Association Class III or IV heart failure

Precautions

Use cautiously in:
• edema, hepatic impairment
• symptomatic heart failure (use not recommended)
• female patients of childbearing age
• pregnant or breastfeeding patients
• children (safety and efficacy not established).

Administration

• Give with or without food.
• Know that drug may be used with sulfonylureas, metformin, or insulin when combination of diet, exercise, and monotherapy doesn't achieve adequate glycemic control.

Adverse reactions

CNS: headache

CV: congestive heart failure (CHF) or exacerbation of CHF

EENT: sinusitis, pharyngitis

Hematologic: anemia

Metabolic: aggravation of diabetes mellitus, hypoglycemia, hyperglycemia

Musculoskeletal: myalgia

Respiratory: upper respiratory infection

Other: tooth disorders, pain, edema

Interactions

Drug-drug.

Hormonal contraceptives: decreased contraceptive efficacy

Ketoconazole: increased pioglitazone effects

Drug-diagnostic tests.Creatine kinase: transient increase

Hematocrit, hemoglobin: decreased values (usually during first 4 to 12 weeks of therapy)

Drug-herbs.Chromium, coenzyme Q10, fenugreek: additive hypoglycemic effects

Glucosamine: poor glycemic control

Patient monitoring

Monitor patient carefully for signs and symptoms of heart failure (including excessive, rapid weight gain; dyspnea; and edema) after initiation and after dosage increases. Consider discontinuation or dosage reduction if these symptoms appear.
• Assess patient's weight and compliance with diet and exercise program.
• Monitor liver function tests before and during therapy.
• Monitor glycosylated hemoglobin, hemoglobin, hematocrit, and blood glucose levels.
• Assess for signs and symptoms of hypoglycemia or hyperglycemia.

Patient teaching

• Instruct patient to take exactly as prescribed. Tell him he may take drug without regard to food.
• Tell patient drug may increase his risk for EENT and respiratory infections. Instruct him to contact prescriber if symptoms occur.

Advise patient to immediately report unexplained nausea, vomiting, abdominal pain, fatigue, anorexia, dark urine, fever, trauma, infection, rapid weight gain, edema, or shortness of breath.
• Tell premenopausal anovulatory patient that drug may cause ovulation. Recommend use of reliable contraception.
• Advise female of childbearing age to contact prescriber promptly if pregnancy occurs.
• As appropriate, review all other significant and life-threatening adverse reactions and interactions, especially those related to the drugs, tests, and herbs mentioned above.

pioglitazone

(pi-o-glit-a-zone) ,

Actos

(trade name)

Classification

Therapeutic: antidiabetics
Pharmacologic: thiazolidinediones
Pregnancy Category: C

Indications

Type 2 diabetes mellitus (with diet and exercise); may be used with metformin, sulfonylureas, or insulin.

Action

Improves sensitivity to insulin by acting as an agonist at receptor sites involved in insulin responsiveness and subsequent glucose production and utilization.
Requires insulin for activity.

Therapeutic effects

Decreased insulin resistance, resulting in glycemic control without hypoglycemia.

Pharmacokinetics

Absorption: Well absorbed following oral administration.
Distribution: Unknown.
Protein Binding: >99% bound to plasma proteins. Active metabolites are also highly (>99%) bound.
Metabolism and Excretion: Extensively metabolized by the liver (primarily by CYP2C8); at least two metabolites have pharmacologic activity. Minimal renal excretion of unchanged drug.
Half-life: Pioglitazone—3–7 hr; total pioglitazone (pioglitazone plus metabolites)—16–24 hr.

Time/action profile (effects on blood glucose)

ROUTEONSETPEAKDURATION
PO30 min2–4 hr24 hr

Contraindications/Precautions

Contraindicated in: Hypersensitivity;Type 1 diabetes;Diabetic ketoacidosis;Clinical evidence of active liver disease or ↑ ALT (>2.5 times upper limit of normal);Active bladder cancer; Obstetric / Lactation: Insulin should be used to control blood glucose levels; Pediatric: Children.
Use Cautiously in: Edema;HF (avoid use in moderate to severe HF);Hepatic impairment;History of bladder cancer;Women (may ↑ distal upper and lower limb fractures);Women with childbearing potential (may restore ovulation and ↑ risk of pregnancy).

Adverse Reactions/Side Effects

Cardiovascular

  • chf (life-threatening)
  • edema

Ear, Eye, Nose, Throat

  • macular edema

Gastrointestinal

  • liver failure (life-threatening)
  • ↑ liver enzymes

Genitourinary

  • bladder cancer (especially after >1 yr) (life-threatening)

Hematologic

  • anemia

Musculoskeletal

  • rhabdomylolysis (life-threatening)

Miscellaneous

  • fractures (arm, hand, foot) in female patients

Interactions

Drug-Drug interaction

May ↓ efficacy of hormonal contraceptives.Strong CYP2C8 inhibitors, including gemfibrozil may ↑ levels.Ketoconazole may ↑ effects of pioglitazone.Concurrent use with insulin may ↑ risk of fluid retention and worsening HF.Glucosamine may worsen blood glucose control.Chromium, and coenzyme Q-10 may produce ↑ hypoglycemic effects.

Route/Dosage

Oral (Adults) No heart failure—15–30 mg once daily, may be ↑ in increments of 15 mg/day to 45 mg/day if needed; NYHA class I-II heart failure—15 mg once daily; may be ↑ in increments of 15 mg/day to 45 mg/day if needed; Concurrent use of gemfibrozil—do not exceed 15 mg once daily.

Availability (generic available)

Tablets: 15 mg, 30 mg, 45 mg Cost: Generic — 15 mg $25.49 / 90, 30 mg $22.75 / 90, 45 mg $38.12 / 90
In combination with: metformin (Actoplus Met, Actoplus Met XR), glimepride (Duetact), alogliptin (Oseni); see combination drugs.

Nursing implications

Nursing assessment

  • Observe patient taking concurrent insulin for signs and symptoms of hypoglycemic reactions (sweating, hunger, weakness, dizziness, tremor, tachycardia, anxiety).
  • Assess for signs and symptoms of heart failure (edema, dyspnea, rapid weight gain, unusual tiredness) after initiation and with dose increases.
  • Lab Test Considerations: Monitor serum glucose and Hb A1c periodically during therapy to evaluate effectiveness.
    • Monitor CBC with differential periodically during therapy. May cause ↓ in hemoglobin and hematocrit, usually during the first 4–12 wk of therapy; then levels stabilize.
    • Monitor serum AST, ALT, alkaline phosphatase, and total bilirubin levels before starting therapy and periodically thereafter or if jaundice or symptoms of hepatic dysfunction occur. Pioglitazone should not be started in patients with active liver disease or ALT levels >2.5 times the upper limit of normal. Patients with mild ALT ↑ should have more frequent monitoring. If ALT ↑ to >3 times the upper limit of normal, recheck ALT promptly. Discontinue pioglitazone if ALT remains >3 times normal.
    • May cause transient ↑ in CPK levels.

Potential Nursing Diagnoses

Imbalanced nutrition: more than body requirements (Indications)
Noncompliance (Patient/Family Teaching)

Implementation

  • Do not confuse Actos (pioglitazone) with Actonel (risedronate).
  • Patients stabilized on a diabetic regimen who are exposed to stress, fever, trauma, infection, or surgery may require administration of insulin.
  • Oral: May be administered with or without meals.

Patient/Family Teaching

  • Instruct patient to take medication as directed. If dose for 1 day is missed, do not double dose the next day.
  • Explain to patient that this medication controls hyperglycemia but does not cure diabetes. Therapy is long-term.
  • Review signs of hypoglycemia and hyperglycemia with patient. If hypoglycemia occurs, advise patient to take a glass of orange juice or 2–3 tsp of sugar, honey, or corn syrup dissolved in water and notify health care professional.
  • Encourage patient to follow prescribed diet, medication, and exercise regimen to prevent hypoglycemic or hyperglycemic episodes.
  • Instruct patient in proper testing of serum glucose and ketones. These tests should be closely monitored during periods of stress or illness, and health care professional should be notified if significant changes occur.
  • Advise patient to notify health care professional immediately if signs of hepatic dysfunction (nausea, vomiting, upper right abdominal pain, fatigue, anorexia, dark urine, jaundice), bladder cancer (hematuria, dysuria, urinary urgency), or HF (edema, shortness of breath, rapid weight gain, tiredness) occur.
  • Advise patient to inform health care professional of medication regimen before treatment or surgery.
  • Insulin is the preferred method of controlling blood glucose during pregnancy. Counsel female patients that higher doses of oral contraceptives or a form of contraception other than oral contraceptives may be required and to notify health care professional promptly if pregnancy is planned or suspected.
  • Advise patient to carry a form of sugar (sugar packets, candy) and identification describing disease process and medication regimen at all times.
  • Emphasize the importance of routine follow-up exams.

Evaluation/Desired Outcomes

  • Control of blood glucose levels.

Actos

(ăk′tōs′)
A trademark for the drug pioglitazone hydrochloride.

Actos®

Pioglitazone, see there.
References in periodicals archive ?
37 billion to settle approximately 8,000 federal and state lawsuits over its drug Actos.
Takeda believes the company acted responsibly with regard to ACTOS, and firmly stands behind the substantial data confirming a positive benefit/risk profile for ACTOS.
While the research results indicate that rats who consumed only tart cherries had the best results, those who had the combination of tart cherries and Actos also did better than those who only took the drug.
Graham authored a study that was published in The Journal of the American Medical Association (JAMA), which found that, compared to Actos, Avandia increased the risk of stroke, heart failure, and death.
In one acto, we portrayed the racism with which Chicano patients were treated at the local hospital, where they were often denied services.
Gilman Law LLP is offering free legal evaluations to any Actos user who developed bladder cancer during or after treatment with Actos.
For answers regarding Actos settlement funding and the lawsuit funding of other pharmaceutical lawsuits, visit: http://www.
OSAKA, Japan, July 30, 2015 /PRNewswire/ -- Takeda Pharmaceutical Company Limited ("Takeda") today announced the completion of the study to fulfill the post-marketing commitment and submissions of data to regulatory authorities from the Pan European Multi-Database Bladder Cancer Risk Characterization Study, a large (n= 112,674), multi-database retrospective matched cohort study, conducted in four European countries, for pioglitazone containing medicines, including ACTOS (pioglitazone HCI) with up to 10 years of follow-up.
com)-- Nadrich & Cohen LLP, a prominent national law firm, has established a new website geared towards helping Actos users who developed bladder cancer after taking the drug.
s (Indianapolis IN) high-profile experimental once-weekly injectable diabetes drug proved superior to the widely used medicines Actos and Januvia in a clinical trial, according to data presented last week.
This combined product is expected to provide additional blood glucose-lowering effects compared to Actos alone, while also offering anti-hypertensive action and multi-organ protective action derived from ARBs.
The US District Court for the Southern District of New York ruled on February 21 that Takeda's patent covering the active ingredient of ACTOS (pioglitazone HCI) is valid and enforceable.