Source: FDA, National Drug Code (US) Revision Year: 2020
Amitiza is indicated for the treatment of chronic idiopathic constipation (CIC) in adults.
Amitiza is indicated for the treatment of opioid-induced constipation (OIC) in adult patients with chronic non-cancer pain, including patients with chronic pain related to prior cancer or its treatment who do not require frequent (e.g., weekly) opioid dosage escalation.
Limitations of Use:
Effectiveness of Amitiza in the treatment of opioid-induced constipation in patients taking diphenylheptane opioids (e.g., methadone) has not been established [see Clinical Studies (14.2)].
Amitiza is indicated for the treatment of irritable bowel syndrome with constipation (IBS-C) in women at least 18 years old.
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 in Table 1.
Table 1. Recommended Dosage Regimen:
| CIC and OIC | IBS-C | |
|---|---|---|
| Recommended Adult Dosage Regimen | 24 mcg twice daily | 8 mcg twice daily |
| Dosage Adjustment for Hepatic Impairment [see Use in Specific Populations (8.6)] | Moderate Impairment (Child-Pugh Class B): 16 mcg twice daily* | Moderate Impairment (Child-Pugh Class B): No adjustment necessary |
| Severe Impairment (Child-Pugh Class C): 8 mcg twice daily* | Severe Impairment (Child-Pugh Class C): 8 mcg once daily* |
* If the dose is tolerated and an adequate response has not been obtained after an appropriate interval, doses can then be escalated to full dosing with appropriate monitoring of patient response.
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 taking 168 to 192 mcg of Amitiza, and another reported diarrhea and a joint injury on the day of overdose after taking 36 mcg of Amitiza. Adverse reactions that occurred in at least 1% of healthy subjects given a single oral dose of 144 mcg of Amitiza (6 times the highest recommended dose) in a cardiac repolarization study included nausea (45%), diarrhea (35%), vomiting (27%), dizziness (14%), headache (12%), abdominal pain (8%), flushing/hot flash (8%), retching (8%), dyspnea (4%), pallor (4%), stomach discomfort (4%), anorexia (2%), asthenia (2%), chest discomfort (2%), dry mouth (2%), hyperhidrosis (2%), and syncope (2%).
Store at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F).
Protect from light and extreme temperatures.
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