AMITIZA 8 mcg twice daily was approved by the FDA in April 2008 for the treatment of Irritable Bowel Syndrome with Constipation in women ≥ 18 years old.
- FOCUS ON AMITIZA
- PHARMACOKINETIC PROFILE
- EFFICACY IN CLINICAL TRIALS
- CONTRAINDICATIONS, WARNINGS, AND PRECAUTIONS AMITIZA
- DRUG INTERACTIONS
- What is The Correlation Between Amitiza and Weight Loss?
- What Is Amitiza?
- Uses of Amitiza
- Side Effects of Amitiza
- Dosage of Amitiza
- Linzess – weight loss or weight gain?
- Best Extreme Weight Loss Tips
- Amitiza Side Effects
- In Summary
- For the Consumer
- For Healthcare Professionals
- Further information
- More about Amitiza (lubiprostone)
Irritable bowel syndrome (IBS) is a functional gastrointestinal disorder, generally defined as a group of symptoms resulting from changes in bowel function without intestinal structural or biochemical abnormalities.1 Symptoms of IBS include abdominal discomfort, bloating, and altered bowel habits, which can include diarrhea, constipation, or alternating diarrhea and constipation.1
IBS has been further classified into subtypes according to stool patterns. IBS with constipation, or IBSC, is characterized by hard or lumpy stools 25% of the time or more, and loose or watery stools less than 25% of the time.2 Other subtypes of IBS include IBS with diarrhea (IBS-D) and IBS with alternating diarrhea and constipation (IBS-A).
The prevalence of IBS in North America is approximately 10%-15%; of these patients, about 20% suffer from IBS-C.1,3
The diagnosis of IBS-C is made after a complete medical history is obtained and physical examination is performed. IBS-C has no biochemical or structural abnormalities associated with it, so there are no specific tests that can confirm the diagnosis. However, it can be easily diagnosed in the doctor’s office without additional testing.4 According to the American College of Gastroenterology, there is no need to perform routine sigmoidoscopy; colonoscopy; barium enema; stool tests for occult blood, ova and parasite or culture; or thyroid function tests in patients with IBS-C complaints who have no “alarm symptoms.”1 Alarm symptoms include items such as blood in the stool, a greater than 10-pound weight loss, family history of colon cancer, recurring fever, anemia, or chronic severe diarrhea.
Several symptom-based criteria have been used to diagnose IBS-C, including the Manning Criteria and the ROME Criteria. These criteria are most useful for standardizing enrollment of patients into clinical trials, and less useful for clinicians in their clinical practice decisions about diagnosis and treatment of IBS-C.5 Identification of IBS-C can be made if abdominal pain or discomfort is present over at least 6 months and is active within the past 3 months, with 2 or more of the following: 1) relieved with defecation; 2) onset associated with a change in frequency of stool; and 3) onset associated with a change in form (appearance) of stool. Patients can be sub-typed as having IBS-C if they also experience 2 of 3 of the following: 1) <3 spontaneous bowel movements per week, 2) >25% hard stools, and 3) > 25% spontaneous bowel movements associated with straining.2
The goal of treatment is to improve symptoms of IBS-C such as abdominal discomfort, bloating, and constipation.
The general approach to the treatment of IBS-C depends in large part on the type of symptoms the patient is experiencing and their severity. Some patients with mild symptoms may find a slow increase in dietary fiber, a healthy amount of exercise and restful sleep, and education about IBS-C are adequate to improve their condition.5 Patients whose lives are significantly affected by symptoms typically require both lifestyle changes and drug therapy to manage their IBS-C.
Several categories of drugs have been used to treat IBS-C symptoms, including bulk-forming, stimulant, and osmotic laxatives as well as stool softeners and lubricants. These drugs are not indicated or proven to be effective in the relief of global symptoms. Agents such as psyllium, methylcellulose, calcium polycarbophil, lactulose, sorbitol, polyethylene glycol, and magnesium hydroxide may be effective for constipation, but treatment of IBS-C should be aimed at relieving global symptoms.1,2 Antispasmodics such as hyoscyamine and dicyclomine have been studied in patients with IBS-C, but there are insufficient data to recommend these agents for global symptom control.1 Even probiotics have been tried in IBS-C patients to decrease abdominal pain and bloating, but none of these agents have been proven effective and safe for chronic use in treating the global symptoms of IBS-C.
Zelnorm® (tegaserod maleate), a 5-HT4 (serotonin) receptor agonist used to decrease transit time and increase intestinal secretion in women with IBS-C, was until recently available only under a restricted-access program due to its potential for increasing the chance of heart attack, stroke, and worsening heart chest pain that could lead to a heart attack.6 This restricted-access program was closed April 2, 2008, making this drug currently unavailable for general use, except for as an emergency investigational new drug (IND) application option available through the FDA.7
FOCUS ON AMITIZA
AMITIZA 8 mcg twice daily received approval by the FDA for the treatment of IBS-C in women ≥ 18 years old.
Lubiprostone activates chloride channels (ClC-2) in the apical (luminal) membrane of the gastrointestinal epithelium, thereby enhancing the secretion of a chloride-rich intestinal fluid without altering serum electrolyte levels. This activity results in increased motility in the intestine and facilitates the passage of stool.8
Lubiprostone has low systemic availability following oral administration and plasma concentrations are below the level of quantitation (10 pg/mL). Studies in rats given radiolabeled lubiprostone indicate minimal distribution beyond the gastrointestinal tissues. In vitro studies using human liver microsomes indicate that microsomal carbonyl reductase may be involved in the extensive biotransformation of lubiprostone. Further in vitro studies indicate that cytochrome P450 isoenzymes are not involved in the metabolism of lubiprostone. The M3 metabolite, the only measurable active metabolite of lubiprostone, makes up less than 10% of the dose of radiolabeled lubiprostone.8
Peak plasma levels of M3, after a single oral dose of 24 mcg of lubiprostone, occurred at approximately 1.10 hours. In vitro protein binding studies indicate lubiprostone is approximately 94% protein bound.8
The effect of food on the pharmacokinetics of a 72 mcg dose of radiolabeled lubiprostone showed the Cmax decreased by 55% while the AUC0-8 was unchanged when lubiprostone was administered with a high-fat meal. The clinical relevance of the effect of food on the pharmacokinetics of lubiprostone is not clear. However, lubiprostone was administered with food and water in a majority of clinical trials. Dosage and administration instructions for lubiprostone state that lubiprostone be taken twice daily orally with food and water.8
EFFICACY IN CLINICAL TRIALS
AMITIZA 8 mcg, 16 mcg, and 24 mcg, twice daily, were studied in a dose-finding, double-blinded, randomized, placebo-controlled Phase 2 study of 195 adult patients with IBS-C. The primary endpoint was a change from baseline in abdominal discomfort or pain during the first treatment month.9 Given the favorable combination of efficacy and safety profiles seen with the 8 mcg twice daily dose, this dose was chosen for Phase 3 evaluation.
AMITIZA 8 mcg twice daily was studied in 2 double-blinded, placebo-controlled clinical trials of similar design in patients with IBS-C. IBS was defined as having abdominal pain or discomfort occurring over at least 6 months with 2 or more of the following: 1) relieved with defecation; 2) onset associated with a change in frequency of stool; and 3) onset associated with a change in form of stool. Patients were sub-typed as having IBS-C if they also experienced 2 of 3 of the following: 1) < 3 spontaneous bowel movements per week; 2) > 25% hard stools; and 3) > 25% spontaneous bowel movements associated with straining.8 In the 2 studies, an intent-to-treat population of 1154 patients were randomized and received AMITIZA 8 mcg twice daily or placebo twice daily for 12 weeks. The primary efficacy endpoint was assessed weekly using the patient’s response to a global symptom relief question based on a 7-point, balanced scale. Patients considered to be “overall responders” (the primary endpoint of the study) were 13.8% (N=390) and 12.1% (N=379), compared to 7.8% (N=193) and 5.7% (N=192), respectively, in the placebo groups. In both studies, the treatment differences between the placebo and AMITIZA groups were statistically significant. Study 1 also assessed the rebound effect from the withdrawal of AMITIZA. Following the 12 weeks of treatment with AMITIZA 8 mcg twice daily, withdrawal of AMITIZA did not result in a rebound effect.8
In general, AMITIZA 8 mcg twice daily was well tolerated in clinical trials and has a demonstrated safety and efficacy profile for adult female patients with IBS-C. The most common adverse reactions in 1011 patients through 1 year on AMITIZA 8 mcg twice daily (incidence greater than 1%) were nausea (8%), diarrhea (7%), abdominal pain (5%), and abdominal distension (3%) versus 435 patients up to 16 weeks on placebo (4%, 4%, 5%, and 2%, respectively).8
CONTRAINDICATIONS, WARNINGS, AND PRECAUTIONS AMITIZA
is contraindicated in patients with known or suspected mechanical gastrointestinal obstruction. In patients with symptoms suggestive of mechanical gastrointestinal obstruction, the treating healthcare provider should perform a thorough evaluation to confirm the absence of such an obstruction prior to initiating therapy with AMITIZA.8
The safety of AMITIZA in pregnancy has not been evaluated in humans. AMITIZA should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Women who could become pregnant should have a negative pregnancy test prior to beginning therapy with AMITIZA and should be capable of complying with effective contraceptive measures.8
Patients taking AMITIZA may experience nausea. If this occurs, concomitant administration of food with AMITIZA may reduce symptoms of nausea.
AMITIZA should not be prescribed to patients who have severe diarrhea. Patients should be aware of the possibility of diarrhea during treatment, and should be instructed to inform their physician if severe diarrhea and nausea occur.8
In post-marketing clinical trials studying AMITIZA 8 mcg twice daily, there were reports of dyspnea at 0.4% in the treated IBS-C population. These events have usually been described as a sensation of chest tightness and difficulty taking in a breath, and generally have an acute onset within 30 to 60 minutes after taking the first dose. These symptoms generally resolve within a few hours after taking the dose, but recurrence has been frequently reported with subsequent doses.8
Based upon the results of in vitro human microsome studies, there is low likelihood of drug-drug interactions with lubiprostone. In vitro studies using human liver microsomes indicate that cytochrome P450 isoenzymes are not involved in the metabolism of lubiprostone. No additional drug-drug interaction studies have been performed. Based on the available information, no protein binding-mediated drug interactions of clinical significance are anticipated.8
Although the underlying pathophysiology is not completely understood and there is no specific test or cure for IBS-C, patients can learn to manage their symptoms with diet, lifestyle changes, and drug therapy. Pharmacists have the opportunity to refer patients who suffer from the symptoms of IBS-C to their physicians, who now have a demonstrated, well-tolerated, and efficacious therapy available to treat this condition. AMITIZA 8 mcg gelcaps taken twice daily is an approved treatment for adult women who suffer from IBS-C.
What is The Correlation Between Amitiza and Weight Loss?
Amitiza is a medication for providing relief in idiopathic chronic constipation and irritable bowel syndrome. Lubiprostone, the main constituent of amitiza, aids in the increase of intestinal fluid present in the intestines. As a result, the increased fluids assist in regulating the stool excretion process. Weight loss during amitiza intake may often occur as a result of the body’s reaction to the medication. Designed specifically to offer constipation relief, amitiza may lead to minor weight loss as it propels regular stool flow and aids in eliminating compacted fecal matter from the body which may add up to 10 pounds to the patient’s total weight. However, it is not advisable to use amitiza as a remedy to lose weight because it may lead to other complications in the body.
What Is Amitiza?
Amitiza is a laxative which doctors prescribe to people who are dealing with irritable bowel syndrome and chronic constipation-like stomach problems. Lubiprostone is the main constituent of Amitiza which is a chloride channel activator that helps to draw additional fluid into the intestine thereby helping stool to pass through without any difficulty. Some people associate Amitiza with weight loss which is actually not true as it is not the right way to lose weight and may produce side-effects.
Uses of Amitiza
Amitiza is especially prescribed for chronic constipation which leads to difficulty in passing stools. Doctors prescribe Amitiza in the case of long-term chronic constipation.
Also, people who are dealing with an irritable bowel along with constipation shall take this prescribed drug to get significant relief. During such a condition, the patient suffers from bloating, stomach ache, cramps, infrequent stools, etc.
The advised standard dose of Amitiza is 24-48mcg a day, though, it varies with the condition and the needful treatment.
Also Read: A Cup Of Banana Tea Daily Can Aid Weight Loss, Insomnia, And A Lot More Health Issues
Side Effects of Amitiza
Although this medicine is doctor-prescribed and safe, there are certain ill effects that its consumption might bring to the consumer. Instead of helping with weight loss, this medicine leads to weight loss as a side-effect. A research study was done to test the effectiveness of Amitiza where it was found that about 29 percent of the Amitiza consumers experienced nausea. Similarly, around 12 percent of people got diarrhea after taking Amitiza. In some cases, people experienced severe diarrhea situation with Amitiza.
Other minor side effects of Amitiza include acute stomach pain, gas, bloating, heartburn, vomiting, loss of appetite, etc.
Also Read: Reiki and Weight Loss: This Healing Practice Can Make You Slim
Dosage of Amitiza
The only correlation between Amitiza and weight loss is an overdose. Exceeding the dosage of this drug would trigger impromptu weight loss which isn’t healthy at all.
The standard dosage of Amitiza is 8-48mcg per day. Only if it is advised by your doctor, exceed this limit. Or else get ready to face serious repercussions like burning sensations, dry heaves, excessive sweating, fatigue, irregular heartbeat, etc.
Read More on Weight Management
Linzess – weight loss or weight gain?
I have been on it for 6 months and I have not had any weight gain. I’m actually losing weight instead (Which I need to anyways)
I’m only on the 145 mcg dose once in the morning but i’m loving it. I wouldn’t go for 1-2 weeks then i’d go all at once. Pain was crazy bad and was making me pass out. Since starting the Linzess I go every other day with absolutely no pain at all. My attacks have decreased from multiple times a month to maybe once or twice a month (Stress does cause them to still occasionally happen, as well as eating something I didn’t know had dairy in it) But even those attacks the pain has decreased to maybe half of what it was and the passing out hasn’t happened since starting the meds.
I would say it’d definitely be worth a try.
Edit to add: Also you might want to ask your gastro for samples of it. My gastro gave me 3 weeks of free samples to try it out before-hand. I would say it took me maybe a week to start seeing improvements. Do follow the instructions though, such as not eat for 30 mins after taking it (I wait an hour because if I don’t, I do end up with gas and cramps even waiting the 30 mins) and the full 8 oz glass of water. Hope this helps 🙂
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Amitiza Side Effects
Generic Name: lubiprostone
Medically reviewed by Drugs.com. Last updated on Dec 10, 2018.
- Side Effects
Note: This document contains side effect information about lubiprostone. Some of the dosage forms listed on this page may not apply to the brand name Amitiza.
Common side effects of Amitiza include: diarrhea, headache, and nausea. Other side effects include: urinary tract infection, abdominal distention, abdominal pain, dizziness, peripheral edema, sinusitis, vomiting, and flatulence. See below for a comprehensive list of adverse effects.
For the Consumer
Applies to lubiprostone: oral capsule liquid filled
Along with its needed effects, lubiprostone (the active ingredient contained in Amitiza) may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.
Check with your doctor immediately if any of the following side effects occur while taking lubiprostone:
- full or bloated feeling or pressure in the stomach
- stomach pain
- swelling of the abdominal or stomach area
- Black, tarry stools
- blood in the stools
- chest discomfort or pain
- difficult or labored breathing
- general feeling of discomfort or illness
- increased sweating
- joint pain
- loss of appetite
- loss of bowel control
- muscle aches and pains
- runny nose
- sore throat
- stomach discomfort
- tightness in the chest
- trouble sleeping
- unusual tiredness or weakness
Incidence not known
- Blurred vision
- difficulty with swallowing
- dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
- fast, pounding, or irregular heartbeat or pulse
- hives or skin rash
- puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
- stomach tenderness
Get emergency help immediately if any of the following symptoms of overdose occur while taking lubiprostone:
Symptoms of overdose
- Dry heaves
- dry mouth
- feeling of warmth
- lack or loss of strength
- paleness of the skin
- redness of the face, neck, arms, and occasionally, upper chest
- severe, unusual tiredness or weakness
- weight loss
Some side effects of lubiprostone may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:
- Excess air or gas in the stomach or intestines
- passing gas
- bladder pain
- bloody or cloudy urine
- change in taste
- cold sweats
- difficult, burning, or painful urination
- difficulty with moving
- fear or nervousness
- feeling sad or empty
- frequent urge to urinate
- increased weight
- loss of interest or pleasure
- loss of taste
- lower back or side pain
- muscle cramps
- muscle stiffness
- stomach upset
- swollen joints
- tingling of the hands or feet
- unusual drowsiness, dullness, tiredness, or feeling of sluggishness
For Healthcare Professionals
Applies to lubiprostone: oral capsule
Very common (10% or more): Nausea (up to 29%), diarrhea (up to 12%)
Frequency not reported: Intestinal functional disorder, constipation, eructation, fecal incontinence, defecation urgency, frequent bowel movements, gastroesophageal reflux disease, gastritis, hard feces, rectal hemorrhage, pollakiuria
Postmarketing reports: Ischemic colitis
Very common (10% or more): Headache (up to 11%)
Common (1% to 10%): Dizziness
Uncommon (0.1% to 1%): Syncope
Frequency not reported: Dysgeusia, tremor, lethargy
Common (1% to 10%): Palpitations, hot flush
Postmarketing reports: Tachycardia/increased heart rate, hypotension
Common (1% to 10%): Hyperhidrosis
Frequency not reported: Cold sweat, erythema
Postmarketing reports: Rash/urticaria
Common (1% to 10%): Edema, fatigue, chest discomfort/pain, peripheral edema
Frequency not reported: Influenza, pain
Postmarketing reports: Malaise, asthenia, swelling
Common (1% to 10%): Dyspnea
Frequency not reported: Pharyngolaryngeal pain, cough
Postmarketing reports: Throat tightness
Uncommon (0.1% to 1%): Muscle spasms
Frequency not reported: Muscle cramps, joint swelling, myalgia, fibromyalgia
Frequency not reported: Urinary tract infection
Frequency not reported: Increased ALT and AST
Frequency not reported: Electrolyte imbalance, decreased appetite, decreased blood potassium, increased weight, anorexia
Frequency not reported: Anxiety, depression
Postmarketing reports: Hypersensitivity/allergic-type reactions
1. “Product Information. Amitiza (lubiprostone).” Sucampo Pharmaceuticals Inc, Bethesda, MD.
Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.
Some side effects may not be reported. You may report them to the FDA.
- Amitiza – how long does it take to work? Is it better to take after dinner?
More about Amitiza (lubiprostone)
- During Pregnancy
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- Drug class: chloride channel activators
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- Amitiza (AHFS Monograph)
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