AMITIZA Capsule (2020)

Βιβλιογραφική αναφορά

Συγγραφείς

Takeda Pharmaceuticals America, Inc.

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1. Indications and Usage

1.1 Chronic Idiopathic Constipation in Adults Amitiza is indicated for the treatment of chronic idiopathic constipation (CIC) in adults. 1.2 Opioid-Induced Constipation in Adult Patients with Chronic Non-Cancer ...

2. Dosage and Administration

2.1 Recommended Dosage The recommended oral dosage of Amitiza by indication and adjustments for patients with moderate (Child Pugh Class B) and severe (Child Pugh Class C) hepatic impairment are shown ...

3. Dosage Forms and Strengths

Amitiza is available as an oval, gelatin capsule containing 8 mcg or 24 mcg of lubiprostone. 8 mcg capsules are pink and are printed with SPI on one side 24 mcg capsules are orange and are printed with ...

4. Contraindications

Amitiza is contraindicated in patients with known or suspected mechanical gastrointestinal obstruction [see Warnings and Precautions (5.5)].

5. Warnings and Precautions

5.1 Nausea Patients taking Amitiza may experience nausea. Concomitant administration of food with Amitiza may reduce symptoms of nausea [see Adverse Reactions (6.1)]. 5.2 Diarrhea Avoid use of ...

6. Adverse Reactions

The following adverse reactions are described below and elsewhere in labeling: Nausea [see Warnings and Precautions (5.1)] Diarrhea [see Warnings and Precautions (5.2)] Syncope and Hypotension ...

6.1. Clinical Trials Experience

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

6.2. Postmarketing Experience

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

7. Drug Interactions

7.1 Methadone Diphenylheptane opioids (e.g., methadone) have been shown in nonclinical studies to dose-dependently reduce the activation of ClC-2 by lubiprostone in the gastrointestinal tract. There is ...

8.1. Pregnancy

Risk Summary Following oral administration, concentrations of lubiprostone in plasma are below the level of quantitation; however, one of the metabolites, M3, has measurable systemic concentrations ...

8.2. Lactation

Risk Summary There are no data available on the presence of lubiprostone in human milk or the effect of lubiprostone on milk production. There are limited data available on the effect of lubiprostone on ...

8.4. Pediatric Use

Safety and effectiveness have not been established in pediatric patients less than 6 years of age. Effectiveness has not been established in pediatric patients 6 years and older. Efficacy was not demonstrated ...

8.5. Geriatric Use

Chronic Idiopathic Constipation The efficacy of Amitiza 24 mcg twice daily in the elderly (at least 65 years of age) subpopulation with CIC was consistent with the efficacy in the overall study population. ...

8.6. Hepatic Impairment

Patients with moderate hepatic impairment (Child-Pugh Class B) and severe hepatic impairment (Child-Pugh Class C) experienced markedly higher systemic exposure of lubiprostone active metabolite M3, when ...

10. Overdosage

There have been six reports of overdosage with Amitiza during clinical development. Of these six cases, only two subjects reported adverse events: one reported vomiting, diarrhea and stomach ache after ...

11. Description

Amitiza (lubiprostone) is a chloride channel activator for oral use. The chemical name for lubiprostone is (–)7[(2R,4aR,5R,7aR)2(1,1-difluoropentyl)-2-hydroxy-6-oxooctahydrocyclopenta[ ...

12.1. Mechanism of Action

Lubiprostone is a locally acting chloride channel activator that enhances a chloride-rich intestinal fluid secretion without altering sodium and potassium concentrations in the serum. Lubiprostone acts ...

12.2. Pharmacodynamics

Although the pharmacologic effects of lubiprostone in humans have not been fully evaluated, animal studies have shown that oral administration of lubiprostone increases chloride ion transport into the ...

12.3. Pharmacokinetics

Following oral administration, concentrations of lubiprostone in plasma are below the level of quantitation (10 pg/mL). Therefore, standard pharmacokinetic parameters such as area under the curve (AUC), ...

13.1. Carcinogensis, Mutagenesis, Impairment of Fertility

Carcinogenesis Two 2-year oral (gavage) carcinogenicity studies (one in Crl:B6C3F1 mice and one in Sprague-Dawley rats) were conducted with lubiprostone. In the 2-year carcinogenicity study in mice, lubiprostone ...

14. Clinical Studies

14.1 Chronic Idiopathic Constipation in Adults Two double-blinded, placebo-controlled studies of identical design were conducted in patients with CIC. CIC was defined as, on average, less than 3 SBMs per ...

16.1. How Supplied

Amitiza is available as an oval, soft gelatin capsule containing 8 mcg or 24 mcg of lubiprostone with SPI printed on one side. Amitiza is available as follows: 8 mcg pink capsule Bottles of 60 (NDC 64764-080-60) ...

16.2. Storage and Handling

Store at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F). Protect from light and extreme temperatures.

17. Patient Counseling Information

Administration Instructions Instruct patients to take Amitiza orally with food and water to reduce the occurrence of nausea [see Warnings and Precautions (5.1)]. Swallow capsules whole and do ...