lubiprostone 24 ug capsule
1 INDICATIONS AND USAGE Lubiprostone capsules are a chloride channel activator indicated for the treatment of: chronic idiopathic constipation (CIC) in adults. (1.1) 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. (1.2) Limitations of Use : Effectiveness of lubiprostone capsules in the treatment of OIC in patients taking diphenylheptane opioids (e.g., methadone) has not been established. (1.2, 7.1) irritable bowel syndrome with constipation (IBS-C) in women ≥ 18 years old. (1.3) 1.1 Chronic Idiopathic Constipation in Adults Lubiprostone capsules are indicated for the treatment of chronic idiopathic constipation (CIC) in adults. 1.2 Opioid-Induced Constipation in Adult Patients with Chronic Non-Cancer Pain Lubiprostone capsules are 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 lubiprostone capsules in the treatment of opioid-induced constipation in patients taking diphenylheptane opioids (e.g., methadone) has not been established [see Clinical Studies (14.2) ] . 1.3 Irritable Bowel Syndrome with Constipation Lubiprostone capsules are indicated for the treatment of irritable bowel syndrome with constipation (IBS-C) in women at least 18 years old.
amneal pharmaceuticals llc
OVAL ORANGE A42
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16 HOW SUPPLIED/STORAGE AND HANDLING
LUBIPROSTONE capsules, 8 mcg , are supplied as pink, oval, soft gelatin capsules imprinted with “A41”. They are available as follows: Bottles of 60 NDC 65162-841-06 Bottles of 180 NDC 65162-841-18
LUBIPROSTONE capsules, 24 mcg , are supplied as orange, oval, soft gelatin capsules imprinted with “A42”. They are available as follows: Bottles of 60 NDC 65162-842-06 Bottles of 180 NDC 65162-842-18 Store at 20° to 25°C (68° to 77°F); excursions permitted between 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature]. Protect from light and extreme temperatures.
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