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Buy Amitiza Online - Buy Lubiprostone Online
AMITIZA is indicated for the treatment of chronic idiopathic
constipation in the adult population.
Generic
Name: Lubiprostone
Date of Approval: January 31, 2006
Company: Sucampo Pharmaceuticals, Inc.
Amitiza
is the first selective chloride channel activator approved for
therapeutic use and has been shown to offer effective relief of chronic
idiopathic constipation in adults.
This condition affects women more often than men and also affects older
patients after the age of 65 more frequently.
The approval is primarily based on data from two pivotal, double-blind,
placebo-controlled studies, which showed that approximately 60 percent
of patients who used Amitiza experienced a spontaneous bowel movement
within the first 24 hours. Additionally, Amitiza was shown to decrease
abdominal bloating, abdominal discomfort and constipation severity when
administered over the 6-12 month treatment period.
Amitiza works by increasing fluid secretion and motility in the
intestine, and thereby increasing the passage of the stool and
alleviating symptoms associated with chronic idiopathic constipation.
Amitiza is contraindicated in patients with a known hypersensitivity to
the drug or its components, and in patients with a history of mechanical
gastrointestinal obstruction. The safety of Amitiza during pregnancy has
not been evaluated. Women planning to use Amitiza should confirm that
they are not pregnant prior to start of medication. The most common side
effects associated with Amitiza treatment during clinical trials were
nausea, diarrhea, and headache. Taking Amitiza with a meal or food may
reduce the symptoms of nausea.
Constipation
is one of the most common digestive complaints, affecting over 33
million adults in the United States. It is the cause of 2.5 million
visits to physicians and 92,000 hospitalizations annually.
AMITIZA should not be used in patients with a known hypersensitivity to
any components of the formulation and in patients with a history of
mechanical gastrointestinal obstruction. Patients with symptoms
suggestive of mechanical gastrointestinal obstruction should be
evaluated prior to initiating AMITIZA treatment.
Amitiza Side Effects
Participants treated with Amitiza had a higher frequency of bowel
movements in the first week than the placebo group in both studies, and
the results continued through four weeks of therapy. Approximately 60%
of patients taking Amitiza had a spontaneous bowel movement within the
first 24 hours.
Three long-term studies showed that Amitiza decreased constipation
severity, abdominal bloating, and discomfort over six to 12 months of
use, said the FDA.
Common side effects included headache, nausea, diarrhea, abdominal pain,
and distension, although, said the FDA, it wasn't clear whether those
events were related to the drug.
Amitiza will be co-marketed by Sucampo Pharmaceuticals and Takeda
Pharmaceuticals America.
Amitiza for Chronic Idiopathic Constipation
Amitiza (Lubiprostone) is the first of a new class of chloride
channel activating drugs developed to act locally on the intestinal
chloride channel, CIC-2. It uses normal physiologic mechanisms to
induce fluid secretion through intestinal cells without altering serum
electrolyte balance. Amitiza is indicated for treatment of chronic
idiopathic constipation (CIC) in adults. Amitiza brings a new
direction in relief for patients with this condition.
FDA Approves Amitiza for Chronic Idiopathic Constipation
The FDA announced it has approved Amitiza (lubiprostone), the first
selective chloride channel activator, for chronic idiopathic
constipation in adults.
The agent, which will be administered in capsule form twice daily with
food, increases intestinal fluid secretions to help ease the passage of
stool, according to the FDA.
The agency said its decision was based on the results of two
placebo-controlled clinical trials. They studied Amitiza with patients
who averaged fewer than three spontaneous bowel movements per week who
had with symptoms of constipation for at least six months.
Participants treated with Amitiza had a higher frequency of bowel
movements in the first week than the placebo group in both studies, and
the results continued through four weeks of therapy. Approximately 60%
of patients taking Amitiza had a spontaneous bowel movement within the
first 24 hours.
Three long-term studies showed that Amitiza decreased constipation
severity, abdominal bloating, and discomfort over six to 12 months of
use, said the FDA.
Common side effects included headache, nausea, diarrhea, abdominal pain,
and distension, although, said the FDA, it wasn't clear whether those
events were related to the drug.
Amitiza will be co-marketed by Sucampo Pharmaceuticals and Takeda
Pharmaceuticals America. |