Amitiza is used for what

What to Expect When Taking AMITIZA

AMITIZA is used for 3 types of chronic constipation: CIC in adults, OIC in adults with chronic pain that is not caused by active cancer, and IBS-C in women ≥ 18 years. Effectiveness in patients taking methadone has not been established.

Important Safety Information

AMITIZA (lubiprostone) is not for everyone. If you know or suspect you have a bowel blockage, do not take AMITIZA. If you are unsure, your healthcare provider (HCP) should evaluate your condition before starting AMITIZA.

Some patients taking AMITIZA may experience nausea. Take AMITIZA with food and water to reduce the occurrence of nausea.

Do not take AMITIZA if you have severe diarrhea. Some patients taking AMITIZA may experience diarrhea. If your diarrhea becomes severe, stop taking AMITIZA and tell your HCP.

Patients may experience fainting and low blood pressure after taking the first dose or repeated doses of AMITIZA. Stop taking AMITIZA and tell your HCP if these reactions occur. Symptoms usually go away before the next dose but may recur with repeated use. Tell your HCP if you are taking any medications to lower blood pressure. Other side effects such as diarrhea or vomiting may increase the risk of fainting and low blood pressure.

Within an hour of taking AMITIZA, a sensation of chest tightness and shortness of breath may occur. These symptoms usually go away within three hours, but may recur with repeated use. Tell your HCP if you experience these symptoms.

The most common side effects of taking AMITIZA 24 mcg twice daily for CIC are nausea, diarrhea, headache, abdominal pain, abdominal distension, and gas. The most common side effects of taking AMITIZA 24 mcg twice daily for Opioid-Induced Constipation are nausea and diarrhea. The most common side effects of taking AMITIZA 8 mcg twice daily for IBS-C are nausea, diarrhea, and abdominal pain. These are not all the side effects associated with AMITIZA.

Tell your HCP if you are taking a diphenylheptane opioid (e.g., methadone).

AMITIZA has not been studied in pregnant women. Based on animal studies, AMITIZA may cause fetal harm. AMITIZA should only be used during pregnancy if the potential benefits justify the potential risk to the fetus. If you are pregnant or become pregnant while being treated with AMITIZA, talk to your HCP to evaluate the risks to the fetus. Tell your HCP if you are nursing and monitor infants for diarrhea.

Tell your HCP if you have liver problems.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.

Indications

AMITIZA (lubiprostone) 24 mcg capsules twice daily is approved to treat Chronic Idiopathic Constipation (CIC) in adults. “Idiopathic” means the cause of the constipation is unknown and not due to an underlying illness or medication. AMITIZA 24 mcg twice daily is also approved to treat constipation caused by opioids, a type of prescription pain medicine, in adults with chronic pain that is not caused by active cancer. The effectiveness of AMITIZA has not been established if you are taking a diphenylheptane opioid (e.g., methadone). AMITIZA 8 mcg capsules twice daily is approved to treat Irritable Bowel Syndrome with Constipation (IBS-C) in women ≥ 18 years of age.

Please for complete Prescribing Information.

Amitiza vs Linzess: Main Differences and Similarities

If you suffer from chronic idiopathic constipation (CIC), Amitiza and Linzess are two different options that can help treat this condition. Although both medications can increase bowel movements, they work slightly differently. Amitiza belongs to a class of drugs called chloride channel activators while Linzess belongs to a drug group called guanylate cyclase-C agonists.

Amitiza

Amitiza is the brand name for lubiprostone. While it can treat CIC in adults, it can also treat opioid-induced constipation (OIC) in adults taking opioid drugs for pain. Additionally, Amitiza can treat irritable bowel syndrome with constipation (IBS-C) in adult women over 18 years old.

Amitiza is available in a 8 mcg or 24 mcg oral capsule. It it usually dosed twice daily depending on your condition and doctor’s instruction. It is also recommended to be taken with food and water for better absorption.

Linzess

Linzess is also recognized by its generic or chemical name, linaclotide. It is a newer drug compared to Amitiza that can treat CIC and IBS-C in adults.

Linzess can be administered as a 72 mcg, 145 mcg, or 290 mcg oral capsule. Unlike Amitiza, it is typically dosed once daily. It needs to be taken on an empty stomach at least 30 minutes before the first meal of the day.

Amitiza vs Linzess Side by Side Comparison

Amitiza and Linzess work in different ways to treat conditions with constipation. They can be further compared in the table below as there are some similarities between the two.

Amitiza Linzess
Prescribed For
  • Chronic idiopathic constipation (CIC)
  • Opioid-induced constipation (OIC)
  • Irritable bowel syndrome with constipation (IBS-C) in women ≥ 18 years old
  • Chronic idiopathic constipation (CIC)
  • Irritable bowel syndrome with constipation (IBS-C)
Drug Classification
  • Chloride channel activator
  • Guanylate cyclase-C agonist
Manufacturer
  • Sucampo
  • Allergan
Common Side Effects
  • Diarrhea
  • Abdominal pain
  • Flatulence
  • Abdominal distension
  • Nausea
  • Headache
  • Diarrhea
  • Abdominal pain
  • Flatulence
  • Abdominal distension
Is there a generic?
  • No generic available
  • No generic available
Is it covered by insurance?
  • Varies according to your provider
  • Varies according to your provider
Dosage Forms
  • Oral capsule
  • Oral capsule
Average Cash Price
  • $374 (per 60 capsules)
  • $456 (per 30 capsules)
SingleCare Discount Price
  • Amitiza Price
  • Linzess Price
Drug Interactions
  • Diphenylheptane opioids (e.g., methadone)
  • No significant drug interactions reported due low systemic absorption
Can I use while planning pregnancy, pregnant, or breastfeeding?
  • Amitiza is in Pregnancy Category C. Some data shows possible fetal harm. Consult a physician regarding taking Amitiza while pregnant or breastfeeding.
  • Use is not believed to cause fetal harm due to low systemic absorption. However, fetal harm cannot be ruled out. Consult a physician regarding Linzess while pregnant or breastfeeding

Summary

Amitiza and Linzess are effective options to treat constipation from certain conditions. They both treat chronic idiopathic constipation (CIC) and irritable bowel syndrome with constipation (IBS-C). However, Amitiza is only approved to treat IBS-C in women 18 years of age and older while Linzess can treat IBS-C in all affected adults. Amitiza can also treat constipation that occurs from the chronic use of opioids.

Amitiza and Linzess have similar side effects of diarrhea, flatulence, and stomach pain. At the same time, Amitiza can also cause nausea and headache. Amitiza is usually taken twice daily while Linzess can be taken once daily before breakfast. For this reason, Linzess may be preferred for those who have trouble remembering to take their medications every day.

Discuss your treatment options with your doctor. Depending on your overall condition, one medication may be more appropriate over the other. Amitiza and Linzess can only be obtained with a valid prescription and should only be used with recommendations from a doctor.

SIDE EFFECTS

The following adverse reactions are described below and elsewhere in labeling:

  • Nausea
  • Diarrhea
  • Syncope and Hypotension
  • Dyspnea

Clinical Trials Experience

Because clinical studies are conducted under widely varying conditions, adverse reaction rates observed in the clinical studies of a drug cannot be directly compared to rates in the clinical studies of another drug and may not reflect the rates observed in practice.

During clinical development of Amitiza for CIC, OIC, and IBS-C, 1648 patients were treated with Amitiza for 6 months and 710 patients were treated for 1 year (not mutually exclusive).

Chronic Idiopathic Constipation

Adverse Reactions In Adult Dose-Finding, Efficacy, And Long-Term Clinical Studies

The most common adverse reactions (>4%) in CIC were nausea, diarrhea, headache, abdominal pain, abdominal distension, and flatulence.

Table 2 presents data for the adverse reactions that occurred in at least 1% of patients and that occurred more frequently with Amitiza than placebo.

Table 2: Adverse Reactions1 in Clinical Trials of Adults with CIC

System/Adverse Reaction Placebo
N = 316 %
Amitiza 24 mcg Twice Daily
N=1113 %
Nausea 3 29
Diarrhea 1 12
Headache 5 11
Abdominal pain 3 8
Abdominal distension 2 6
Flatulence 2 6
Vomiting 0 3
Loose stools 0 3
Edema <1 3
Abdominal discomfort2 1 3
Dizziness 1 3
Chest discomfort/pain 0 2
Dyspnea 0 2
Dyspepsia <1 2
Fatigue 1 2
Dry mouth < 1 1
1 Reported in at least 1% of patients treated with Amitiza and greater than placebo
2This term combines “abdominal tenderness,” “abdominal rigidity,” “gastrointestinal discomfort,” “stomach discomfort”, and “abdominal discomfort.”

Nausea: Approximately 29% of patients who received Amitiza experienced nausea; 4% of patients had severe nausea and 9% of patients discontinued treatment due to nausea. The rate of nausea was lower among male (8%) and elderly (19%) patients. No patients in the clinical studies were hospitalized due to nausea.

Diarrhea: Approximately 12% of patients who received Amitiza experienced diarrhea; 2% of patients had severe diarrhea and 2% of patients discontinued treatment due to diarrhea.

Electrolytes: No serious adverse reactions of electrolyte imbalance were reported in clinical studies, and no clinically significant changes were seen in serum electrolyte levels in patients receiving Amitiza.

Less Common Adverse Reactions (<1%): fecal incontinence, muscle cramp, defecation urgency, frequent bowel movements, hyperhidrosis, pharyngolaryngeal pain, intestinal functional disorder, anxiety, cold sweat, constipation, cough, dysgeusia, eructation, influenza, joint swelling, myalgia, pain, syncope, tremor, decreased appetite.

Opioid-Induced Constipation

Adverse Reactions In Adult Efficacy And Long-Term Clinical Studies

The data described below reflect exposure to Amitiza 24 mcg twice daily in 860 patients with OIC for up to 12 months and from 632 patients receiving placebo twice daily for up to 12 weeks. The total population (N = 1492) had a mean age of 50 (range 20-89) years; was 63% female; 83% Caucasian, 14% African American, 1% American Indian/Alaska Native, 1% Asian; 5% were of Hispanic ethnicity, and 9% were elderly (≥65 years of age).

The most common adverse reactions (>4%) in OIC were nausea and diarrhea.

Table 3 presents data for the adverse reactions that occurred in at least 1% of patients and that occurred more frequently with study drug than placebo.

Table 3: Adverse Reactions1 in Clinical Trials of Adults with OIC

System/Adverse Reaction1 Placebo
N = 632 %
Amitiza 24 mcg Twice Daily
N = 860 %
Nausea 5 11
Diarrhea 2 8
Abdominal pain 1 4
Flatulence 3 4
Abdominal distension 2 3
Vomiting 2 3
Headache 1 2
Peripheral edema < 1 1
Abdominal discomfort2 1 1
1 Reported in at least 1% of patients treated with Amitiza and greater than placebo
2This term combines “abdominal tenderness,” “abdominal rigidity,” “gastrointestinal discomfort,” “stomach discomfort”, and “abdominal discomfort.”

Nausea: Approximately 11% of patients who received Amitiza experienced nausea; 1% of patients had severe nausea and 2% of patients discontinued treatment due to nausea.

Diarrhea: Approximately 8% of patients who received Amitiza experienced diarrhea; 2% of patients had severe diarrhea and 1% of patients discontinued treatment due to diarrhea.

Less common adverse reactions (<1%):fecal incontinence, blood potassium decreased.

Irritable Bowel Syndrome With Constipation

The data described below reflect exposure to Amitiza 8 mcg twice daily in 1011 patients with IBS-C for up to 12 months and from 435 patients receiving placebo twice daily for up to 16 weeks. The total population (N = 1267) had a mean age of 47 (range 18-85) years; was 92% female; 78% Caucasian, 13% African American, 9% Hispanic, 0.4% Asian, and 8% elderly (≥65 years of age).

The most common adverse reactions (>4%) in IBS-C were nausea, diarrhea, and abdominal pain.

Table 5 presents data for the adverse reactions that occurred in at least 1% of patients and that occurred more frequently with study drug than placebo.

Table 5: Adverse Reactions1 in Clinical Trials of Adults with IBS-C

System/Adverse Reaction Placebo
N = 435 %
Amitiza 8 mcg Twice Daily
N = 1011 %
Nausea 4 8
Diarrhea 4 7
Abdominal pain 5 5
Abdominal distension 2 3
1 Reported in at least 1% of patients treated with Amitiza and greater than placebo

Nausea: Approximately 8% of patients who received Amitiza 8 mcg twice daily experienced nausea; 1% of patients had severe nausea and 1% of patients discontinued treatment due to nausea.

Diarrhea: Approximately 7% of patients who received Amitiza 8 mcg twice daily experienced diarrhea; <1% of patients had severe diarrhea and <1% of patients discontinued treatment due to diarrhea.

Less common adverse reactions (<1%): dyspepsia, loose stools, vomiting, fatigue, dry mouth, edema, increased alanine aminotransferase, increased aspartate aminotransferase, constipation, eructation, gastroesophageal reflux disease, dyspnea, erythema, gastritis, increased weight, palpitations, urinary tract infection, anorexia, anxiety, depression, fecal incontinence, fibromyalgia, hard feces, lethargy, rectal hemorrhage, pollakiuria.

Postmarketing Experience

The following additional adverse reactions have been identified during post-approval use of Amitiza. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

Cardiovascular: syncope and/or hypotension , tachycardia

Gastrointestinal: ischemic colitis

General: asthenia

Immune System: hypersensitivity reactions including rash, swelling, and throat tightness malaise

Muscoskeletal: muscle cramps or muscle spasms.

Read the entire FDA prescribing information for Amitiza (Lubiprostone)

Generic Name: lubiprostone (loo bee PROS tone)
Brand Names: Amitiza

Medically reviewed by Sanjai Sinha, MD Last updated on Mar 10, 2019.

  • Overview
  • Side Effects
  • Dosage
  • Professional
  • Interactions
  • More

What is Amitiza?

Amitiza (lubiprostone) increases the secretion of fluid in your intestines to help make it easier to pass stools (bowel movements).

Amitiza is used to treat chronic chronic constipation, or constipation caused by opioid (narcotic) pain medicine.

Amitiza may also be used to treat irritable bowel syndrome in women with constipation as the main symptom.

Amitiza is only for use in adults.

Important Information

You should not use Amitiza if you have a blockage in your digestive tract, or if you have severe diarrhea.

Stop taking Amitiza and call your doctor if you feel light-headed every time you take this medicine.

A nursing baby could develop diarrhea if the mother takes lubiprostone while breast-feeding. Tell your doctor if you are breast-feeding a baby, and talk with your doctor if the baby develops diarrhea.

You may have tightness in your chest or feel short of breath within 1 hour of taking this medicine. This side effect should go away within 3 hours, but it may occur again when you take your next dose. Talk with your doctor if this side effect becomes bothersome.

Call your doctor at once if you have severe or ongoing nausea or diarrhea.

Before taking this medicine

You should not use Amitiza if you have a blockage in your digestive tract, or if you have severe diarrhea.

Tell your doctor if you have ever had liver disease.

Tell your doctor if you are pregnant or breastfeeding.

A nursing baby could develop diarrhea if the mother takes Amitiza while breastfeeding. Ask your doctor about any risk, and tell your doctor if the baby develops diarrhea.

How should I take Amitiza?

Amitiza is usually taken twice daily. Follow all directions on your prescription label and read all medication guides or instruction sheets.

Take Amitiza with food and water to prevent nausea.

Swallow the capsule whole and do not crush, chew, break, or open it.

You may have tightness in your chest or feel short of breath within 1 hour after taking Amitiza. This side effect should go away within 3 hours, but it may occur again when you take your next dose. Talk with your doctor if this side effect becomes bothersome.

Do not take this medicine if you have severe diarrhea. Call your doctor for instructions.

Your doctor will need to check your progress on a regular basis.

Store at room temperature away from moisture and heat.

Amitiza dosing information

Usual Adult Dose for Constipation — Chronic:

24 mcg orally 2 times a day
Comments: The effectiveness of this drug in the treatment of opioid-induced constipation in patients taking diphenylheptane opioids (e.g., methadone) has not been established.
Use: Treatment of chronic idiopathic constipation and of opioid-induced constipation in adults with chronic non-cancer pain.

Usual Adult Dose for Irritable Bowel Syndrome:

8 mcg orally 2 times a day
Use: Treatment of irritable bowel syndrome with constipation (IBS-C) in women age 18 years and older.

What happens if I miss a dose?

Take the medicine as soon as you can, but skip the missed dose if it is almost time for your next dose. Do not take two doses at one time.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

What should I avoid while taking Amitiza?

Follow your doctor’s instructions about any restrictions on food, beverages, or activity.

Amitiza side effects

Get emergency medical help if you have signs of an allergic reaction to Amitiza: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have:

  • trouble breathing;

  • severe or ongoing nausea or diarrhea; or

  • a light-headed feeling, like you might pass out.

You may have low blood pressure and feel faint shortly after taking this medicine, especially if you’ve been sick with vomiting or diarrhea. Stop taking Amitiza and call your doctor if you feel light-headed after every dose.

Common Amitiza side effects may include:

  • nausea, stomach pain;

  • diarrhea, gas, bloating; or

  • headache.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What other drugs will affect Amitiza?

Make sure your doctor knows if you are using opioid pain medicine.

Other drugs may interact with lubiprostone, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell your doctor about all your current medicines and any medicine you start or stop using.

Further information

Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use Amitiza only for the indication prescribed.

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Copyright 1996-2020 Cerner Multum, Inc. Version: 3.01.

Related questions

  • Amitiza – how long does it take to work? Is it better to take after dinner?

Medical Disclaimer

More about Amitiza (lubiprostone)

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  • … +1 more

Related treatment guides

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AMITIZA 8 mcg dose is the only widely available FDA-approved prescription medication for Irritable Bowel Syndrome with Constipation

Bethesda, Md., and Deerfield, Ill., May 27, 2008 – Sucampo Pharmaceuticals, Inc. (Nasdaq: SCMP) and Takeda Pharmaceuticals North America, Inc. today announced that AMITIZA® (lubiprostone) 8 mcg capsules are now available by prescription in pharmacies across the U.S. for the treatment of Irritable Bowel Syndrome with Constipation (IBS-C) in women 18 years and older. AMITIZA 24 mcg capsules have been available by prescription to treat Chronic Idiopathic Constipation in adults since 2006.

AMITIZA is the only widely available FDA-approved prescription treatment option that can provide overall symptom relief for the millions of adult women in the U.S. with IBS-C.

AMITIZA has a mechanism of action that works locally in the intestine to increase fluid secretion, resulting in increased passage of stool and alleviating symptoms associated with Chronic Idiopathic Constipation. Although it is not well understood how AMITIZA works to reduce symptoms in patients with IBS-C, ex vivo animal studies suggest that AMITIZA stimulates recovery of mucosal barrier function by restoring tight junction protein complexes.

“The effects of IBS-C can be debilitating and far-reaching—affecting many aspects of a person’s life,” said Charles Baum, M.D., gastroenterologist, executive medical director, Gastroenterology and Internal Medicine, at Takeda Pharmaceuticals North America, Inc. “The availability of AMITIZA makes it possible for appropriate patients to receive a widely available prescription medication that can be an important tool to help treat this condition.”

“I am very pleased with the quick commercial launch of AMITIZA 8 mcg for this particular indication as it could provide a treatment option to many adult women suffering from IBS-C,” said Ryuji Ueno, M.D., Ph.D., Ph.D., founder, chairman and chief executive officer, Sucampo Pharmaceuticals.

AMITIZA was developed by Sucampo Pharmaceuticals and is co-marketed in the U.S. by Sucampo Pharmaceuticals and Takeda Pharmaceuticals North America, Inc.

About Irritable Bowel Syndrome with Constipation (IBS-C)

IBS is a disorder characterized by symptoms including abdominal discomfort or pain, bloating and changes of bowel habits such as constipation and/or diarrhea. There are three main types of IBS: IBS with constipation (IBS-C), IBS with diarrhea (IBS-D) and IBS with mixed constipation and diarrhea (IBS-M). In IBS-C, symptoms are present for at least 12 weeks (not necessarily consecutive) over a 12-month period. Although people with IBS-C report many of the symptoms associated with constipation, the presence of abdominal discomfort or pain is what differentiates IBS-C from chronic constipation. IBS is approximately two to two-and-a-half times more prevalent in women than men.

About AMITIZA® (lubiprostone) for Chronic Idiopathic Constipation and IBS-C Indication

AMITIZA® (lubiprostone) is indicated for the treatment of Chronic Idiopathic Constipation (24 mcg) in adults and for Irritable Bowel Syndrome with Constipation (8 mcg) in women ≥ 18 years old.

Important Safety Information

AMITIZA is contraindicated in patients with known or suspected mechanical gastrointestinal obstruction. Patients with symptoms suggestive of mechanical gastrointestinal obstruction should be thoroughly evaluated by the treating physician to confirm the absence of such an obstruction prior to initiating AMITIZA treatment.

The safety of AMITIZA in pregnancy has not been evaluated in humans. AMITIZA should be used during pregnancy only if the 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.

Patients taking AMITIZA may experience nausea. If this occurs, concomitant administration of food with AMITIZA may reduce symptoms of nausea. Patients who experience severe nausea should inform their physician.

AMITIZA should not be prescribed to patients that have severe diarrhea. Patients should be aware of the possible occurrence of diarrhea during treatment and inform their physician if the diarrhea becomes severe.

Patients taking AMITIZA may experience dyspnea within an hour of first dose. This symptom generally resolves within three hours, but may recur with repeat dosing. Patients who experience dyspnea should inform their physician.

Please see complete Prescribing Information at www.amitiza.com.

AMITIZA is co-marketed by Sucampo Pharmaceuticals, Inc. and Takeda Pharmaceuticals North America, Inc.

AMITIZA® is a registered trademark of Sucampo Pharmaceuticals, Inc.

Sucampo Pharmaceuticals, Inc.

Sucampo Pharmaceuticals, Inc., a specialty biopharmaceutical company based in Bethesda, Md., focuses on the development and commercialization of medicines based on prostones. The therapeutic potential of prostones, which are bio-lipids that occur naturally in the human body, was first identified by Ryuji Ueno, M.D., Ph.D., Ph.D., Sucampo Pharmaceuticals’ chairman and chief executive officer. Dr. Ueno founded Sucampo Pharmaceuticals in 1996 with Sachiko Kuno, Ph.D., founding chief executive officer and advisor, international business development.

Sucampo Pharmaceuticals is marketing AMITIZA (lubiprostone) in the U.S. for Chronic Idiopathic Constipation in adults and Irritable Bowel Syndrome with Constipation in adult women ≥ 18 years old, and is developing the drug for additional gastrointestinal disorders with large potential markets. In addition, Sucampo Pharmaceuticals has a robust pipeline of compounds with the potential to target underserved diseases affecting millions of patients worldwide. Sucampo Pharmaceuticals has two wholly owned subsidiaries: Sucampo Pharma Europe, Ltd. headquartered in Oxford, U.K., with a branch office in Basel, Switzerland, and Sucampo Pharma, Ltd., located in Tokyo and Osaka, Japan.

To learn more about Sucampo Pharmaceuticals and its products, visit www.sucampo.com.

Takeda Pharmaceuticals North America, Inc.

Based in Deerfield, Ill., Takeda Pharmaceuticals North America, Inc. is a wholly owned subsidiary of Takeda Pharmaceutical Company Limited, the largest pharmaceutical company in Japan. In the United States, Takeda currently markets products for diabetes, insomnia, wakefulness and gastroenterology. The company has a robust pipeline with compounds in development for diabetes, cardiovascular disease and other conditions. Takeda is committed to striving toward better health for individuals and progress in medicine by developing superior pharmaceutical products. To learn more about the company and its products, visit www.tpna.com.

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