AMITIZA *
Manufacturer Details
TAKEDA PHARMACEUTICALS INC
Takeda pharmaceuticals America Inc
Compositions:
Lubiprostone 8 mcg capsules in 60s pack,
Lubiprostone 24 mcg capsules in 60s pack,
Strength
|
Rate
|
Packing Style
|
8mcg
|
0.00
|
60s capsules
|
24mcg
|
0.00
|
60s capsules
|
List of Related Indications:
- Chronic idiopathic constipation
- Irritable bowel syndrome
List Of Drugs:
- Lubiprostone - @-Gastrointestinal agents-(Oct 2010)
Indication Type Description:
Drug Interaction:
Methadone, antihypertensives
Indication:
Approved by (DCI) Drug Controller GENERAL - India For Marketing
(Ref- IDMA Publication)
Name of Drug Indication Date of Approval
Lubiprostone Soft gelatin 16-10-2010
capsules 8mcg/24mcg
i.For the treatment of chronic constipation in adults
ii. For the treatment of irritable bowel syndrome with consitpation
(IBS-C) in women > 18 years old
Chronic idiopathic constipation
Irritable bowel syndrome
Adverse Reaction:
Adverse reactions-
CNS - dizziness , fatigue < 1%, heaache 4%
GI - abdominal distention 2% abdominal pain 3% diarrhea, dry mouth, dyspepsia <1%
nausea 3%
Contra-Indications:
Known hypersensitivity to the drug, history of technical GI obstruction
Special Precautions-
GI effects- do not administer to who have severe diarrhea
Dyspnea- dyspnea has occurred in patients treated with 24mcg, but generally resolve itself
with few hours. If it persists discontinue treatment.
GI obstruction- evaluate patients with symptoms suggestive of mechanical GI obstruction
prior to initiating lubiprostone treatment
Pregnancy- use lubiprostone during pregnancy only only if potential benefit justifies the
potential risk to fetus.
Lactation- decide whether to discontinue breast feeding or the drug dependending of
the importance to the mother
Children- safety and efficacy in children have not been established
Elderly- efficacy of lubiprostone in elderly patients over 65 years was consistent with the
overall with other patients
Dosages/ Overdosage Etc:
Indication-
Chronic idiopathic constipation
Irritable bowel syndrome
Dosage-
24mcg taken daily orally with food water
Irritable bowel syndrome with constipation-
8mcg taken twice daily orally with food and water
Patient Information:
To be taken with food and water
Interaction with Food:
To be taken with food and water
Pregnancy and lactation:
Pregnancy-
Use lubiprostone during pregnancy only only if potential benefit justifies the
potential risk to fetus.
Lactation-
Decide whether to discontinue breast feeding or the drug dependending on
the importance to the mother
Children-
Safety and efficacy in children have not been established
Elderly-
Efficacy of lubiprostone in elderly patients over 65 years was consistent with the
overall with other patients