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Why Does Linzess Have To Stay In Original Container

Alternatives For Irritable Bowel Syndrome With Constipation

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Examples of other drugs that may be used to treat irritable bowel syndrome with constipation include:

IBS-C causes constipation along with other symptoms such as bloating or abdominal pain. With CIC, youre often constipated for an unknown reason.

Its believed that Linzess works by increasing the amount of fluid in your intestines. The drug also helps food move more quickly through your digestive tract. This makes bowel movements occur more often, which may help ease symptoms of constipation. How a drug works is called its mechanism of action.

In addition, Linzess may lessen pain in your digestive system by reducing the contraction of digestive muscles and relaxing nerves that sense pain. This may also help treat your symptoms of IBS-C or CIC.

What Are Reasons I Shouldnt Take Linzess

Linzess should not be used:

  • If you are allergic to any of the ingredients in linaclotide capsules. Ask a healthcare provider for a list of the ingredients.
  • If you have any stomach or intestinal blockage and inflammatory bowel disease history. Consult your healthcare provider first.
  • In children under age 6 due to the risk of severe side effects.
  • In children ages 6 to 17. Linzess is not approved for this use.

How To Take Linaclotide Capsules

  • Before you start this treatment, read the manufacturer’s printed information leaflet from inside your pack. It will give you more information about linaclotide and will provide you with a full list of the side-effects which you may experience from taking it.
  • Take linaclotide exactly as your doctor tells you to. It is taken once daily. You can take your dose at a time of day that suits you, but try to take it at around the same time of day, each day.
  • Swallow the capsule whole with a drink of water. It is best taken on an empty stomach . This is because taking the capsules with food increases the possibility that diarrhoea will occur.
  • If you forget to take a dose, take it as soon as you remember. If you do not remember until the following day, skip the forgotten dose. Do not take two doses at the same time to make up for a missed dose.

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What Are Some Side Effects That I Need To Call My Doctor About Right Away

WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:

  • Signs of an allergic reaction, like rash hives itching red, swollen, blistered, or peeling skin with or without fever wheezing tightness in the chest or throat trouble breathing, swallowing, or talking unusual hoarseness or swelling of the mouth, face, lips, tongue, or throat.
  • Black, tarry, or bloody stools.
  • Swelling of belly.
  • Sometimes, very bad diarrhea has led to the need to go to the hospital. Call your doctor right away if you have very bad diarrhea or diarrhea that will not go away. Call your doctor right away if you have signs of dehydration like very bad dizziness or passing out, not able to pass urine or change in how much urine is passed, or feeling very tired.

Does Linzess Interact With Other Medicines

Linzess can interact with other medicines and affect their action. It can also increase the severity of some side effects of other medications. Hence, Linzess should be avoided in people who take laxatives, medicines to treat stomach ulcers, and non-steroidal anti-inflammatory medicines.

Sometimes, diarrhea caused by Linzess can hinder the action of other medicines. For example, diarrhea for a prolonged time can decrease the efficacy of contraceptive pills.

One must take certain precautions before starting Linzess. Any previous episode of allergic reaction to linaclotide should be considered before prescribing Linzess. Not only that, obstruction in the stomach, intestine, pregnancy, breastfeeding females, and children below 18 years should avoid taking Linzess. One must consult a specialist in case of prolonged diarrhea, heart disease, diseases related to the blood vessels, and chronic conditions like Crohns disease.

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Boxed Warning: Risk Of Serious Dehydration In Children Younger Than 2 Years Old

Linzess has a boxed warning for the risk of serious dehydration in children younger than 2 years old. This is a serious warning from the Food and Drug Administration .

Linzess was not tested in children younger than 2 years. But it was tested in animal studies. These studies showed that Linzess raised the risk of dehydration due to severe diarrhea in young mice. In some cases, severe dehydration was fatal in these animals.

Linzess should not be used in children younger than 2 years old. Its important to note that Linzess is only approved for use in adults.

If you have questions about this warning, talk with your doctor.

Why Are These Medications Dispensed In Their Original Containers

When you pick up your medications at the pharmacy you may notice that they are typically dispensed in amber colored vials or plastic containers. You may or may not be aware that these amber colored vials are not the original bottle the manufacturer dispensed the medication in.

For the majority of medications, transferring them from the manufacturers original bottle to the pharmacys amber vials is not a big deal, and lets the pharmacy purchase in bulk unless you are taking certain medications.

Some drugs, per the manufacturer, are to be dispensed in their original container due to the sensitivity, integrity, and stability of the medication. Medications can be sensitive to many things including light, temperature, humidity, or moisture. It is important to properly maintain and store your medications according to the recommendations of the manufacturer.

So what are some examples of medications that need to be dispensed and stored in the original container?


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What If I Miss A Dose

If you miss a dose of Linzess, skip the missed dose. Then take your next dose as scheduled the following day. You should not take two doses of Linzess at once to try to make up for a missed dose.

To help make sure you dont miss a dose, try using a medication reminder. This can include setting an alarm or using a timer. You could also download a reminder app on your phone.

Enhancing Healthcare Team Outcomes


Irritable bowel syndrome with prominent constipation and chronic idiopathic constipation are functional gastrointestinal disorders connected with constipation. IBS-C and CIC together affect about 20% of the general population, including the geriatric group, impairing the overall quality of life. When patients do not respond adequately to over-the-counter therapies, they need safe and effective long-term prescribed treatment. Patients might be intolerant to the more well-established medicines currently available in the market. For adults, linaclotide is a novel remedy with a favorable safety profile.

After obtaining the patient’s informed verbal consent, providers such as primary care physicians, gastroenterologists, nurse practitioners, and physician assistants prescribe linaclotide and set realistic goals for treatment outcomes. Nurses administer the linaclotide via feeding tube in in-patient settings. At discharge, they have opportunities to counsel the patients regarding the drug dosage, administration, treatment compliance, and circumstances when medical attention is necessary.

Article Details

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Irritable Bowel Syndrome With Constipation

The efficacy of Linzess for the management of symptoms of IBS-C was established in two double-blind, placebo-controlled, randomized, multicenter trials in adult patients and 2 ). A total of 800 patients in Trial 1 and 804 patients in Trial 2 received treatment with Linzess 290 mcg or placebo once daily and were evaluated for efficacy. All patients met Rome II criteria for IBS and were required, during the 2-week baseline period, to meet the following criteria:

  • a mean abdominal pain score of at least 3 on a 0-to-10-point numeric rating scale
  • less than 3 complete spontaneous bowel movements per week , and
  • less than or equal to 5 SBMs per week.

The trial designs were identical through the first 12 weeks, and thereafter differed only in that Trial 1 included a 4-week randomized withdrawal period, and Trial 2 continued for 14 additional weeks of double-blind treatment. During the trials, patients were allowed to continue stable doses of bulk laxatives or stool softeners but were not allowed to take laxatives, bismuth, prokinetic agents, or other drugs to treat IBS-C or chronic constipation.

Efficacy of Linzess was assessed using overall responder analyses and change-from-baseline endpoints. Results for endpoints were based on information provided daily by patients in diaries.

Table 3: Efficacy Responder Rates in the Two Placebo-controlled IBS-C Trials: At Least 9 Out of 12 Weeks

Trial 1

Linzess Withdrawal And Dependence

Linzess is not known to cause withdrawal or drug dependence.

Withdrawal can occur when you stop taking a medication that your body is used to. Withdrawal symptoms typically include nausea, sweating, and mood changes.

Dependence can occur when you need to take a medication to feel as you normally do.

Symptoms of constipation may come back if you stop taking Linzess. This is not considered withdrawal or dependence. However, when people in clinical trials stopped taking the drug for a time, it was called a withdrawal period. During this time, their symptoms seemed to worsen.

You should not stop taking Linzess unless you first speak with your doctor. If you have questions about ending your treatment, they can help.

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Linzess For Chronic Idiopathic Constipation

Linzess is approved to treat a digestive condition called chronic idiopathic constipation . With CIC, youre frequently constipated for an unknown reason. Chronic means long term, and idiopathic means the cause isnt known.

Symptoms of CIC can include experiencing the following within a 3-month period:

  • passing stools that are lumpy, hard, or like pebbles
  • having fewer than three bowel movements per week
  • having trouble emptying your bowels

Effectiveness for CIC

Linzess is an effective medication for adults with CIC. In fact, the drug is mentioned as a treatment option for people with CIC in guidelines from The American Journal of Managed Care. For information about how Linzess performed in clinical trials, see the drugs prescribing information.

Do Side Effects Of Linzess Vary Depending On The Strength

In some cases, yes. For example, diarrhea was the most commonly reported side effect in studies of Linzess. The risk of having this side effect was higher in people who took 290 micrograms of Linzess per day than in those who took lower doses.

Also, certain side effects, such as viral gut infections and headache, were only reported in people taking a daily dosage of 290 mcg.

If you have bothersome side effects from Linzess, talk with your doctor. They may be able to adjust your dosage to help relieve your side effects.

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Why Is Linzess So Expensive

Linzess is an expensive prescription medication used once daily to help you have more frequent and complete bowel movements, and it also helps relieve belly pain and overall abdominal symptoms.

Americans pay more for prescription drugs than other developed nations. There are a number of reasons why Linzess may be more expensive than other medications. Linzess is a brand-name drug and there are generic alternatives available for this medication.

Learn more about why Linzess is so expensive and what options are available for you to save on this medication.

Does Linzess Cause Weight Gain Or Weight Loss

No, Linzess doesnt cause weight gain or weight loss. But it can cause diarrhea, which in some cases may lead to weight loss. On the other hand, Linzess may cause bloating, which could lead to weight gain.

Some people who have irritable bowel syndrome with constipation may experience weight gain or weight loss related to their condition.

For example, some people with IBS-C may have trouble tolerating certain foods or absorbing nutrients. This may lead to weight loss.

If youre concerned about changes in your weight while taking Linzess, talk with your doctor.

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Is Linzess Used For Other Digestive Conditions Such As Opioid

At this time, Linzess is not approved to treat opioid-induced constipation , diarrhea, or gastroparesis. Linzess is approved to treat only irritable bowel syndrome with constipation and chronic idiopathic constipation . However, the medication may be used off-label for other digestive conditions. Off-label drug use is when a drug that the Food and Drug Administration has approved is prescribed for a purpose other than what its approved for.

OIC is a condition that may occur in people taking opioids because constipation is sometimes a side effect of opioid treatment. A study of Linzess showed that the drug may ease constipation related to opioid medications.

Linzess can cause diarrhea as a side effect. In some cases, the diarrhea can be severe. Due to this risk, its unlikely that your doctor will recommend Linzess for diarrhea, including irritable bowel syndrome with diarrhea.

There havent been any clinical trials to see whether Linzess is a safe or effective treatment option for gastroparesis. This is a condition that can cause food to move slowly through your digestive system. Linzess works to speed up your digestion and decrease abdominal pain, so it may ease symptoms of gastroparesis. However, at this time, the drug is not approved for this use.

If youre interested in Linzess for OIC, talk with your doctor. They can also advise you on treatments for diarrhea and gastroparesis.

How To Use Linzess

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Read the Medication Guide provided by your pharmacist before you start taking linaclotide and each time you get a refill. If you have any questions, ask your doctor or pharmacist.

Take this medication by mouth on an empty stomach as directed by your doctor, usually once daily at least 30 minutes before your first meal of the day. Swallow the capsules whole. Do not break or chew the capsules.

If you have trouble swallowing the capsule, it may be opened and the contents mixed in a teaspoonful of applesauce. Swallow the mixture right away, without chewing it. Do not save the mixture for future use.

You may also empty the capsule’s content into an ounce of water. Swirl the mixture for 20 seconds and drink right away, without chewing it. Add another ounce of water to the cup, swirl for 20 seconds and drink right away to get your whole dose. The water mixture may also be given through a tube into the stomach . If you are giving this medication through a tube, ask your health care professional for detailed instructions on how to give it.

The dosage is based on your medical condition and response to treatment.

Use this medication regularly to get the most benefit from it. To help you remember, take it at the same time each day.

Tell your doctor if your condition does not improve or if it worsens.

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How Much Does Linzess Cost

According to the manufacturer, the estimated out-of-pocket cost for Linzess without insurance is $490.63 per month , which may vary depending on the dosage prescribed by your healthcare provider. This is the average retail price estimated by the manufacturer.

Linzess price can vary depending on your health insurance coverage for this medication. Contact your insurance company or pharmacist to determine if your health insurance plan covers Linzess in its drug formulary as well as the deductibles and copays for this medication.

Each health insurance plan sets its own formulary that specifies which medications are covered. Some health insurance plans may place Linzess on a higher tier that may result in a higher coinsurance or copayment.

According to the manufacturer, depending on your insurance coverage, eligible individuals may pay as little as $30 for a 30-day or 90-day supply when using the Linzess savings card. Around 85% of prescriptions have an out-of-pocket cost ranging from $0-$35 per month. This offer is not valid for those who are paying cash out-of-pocket, and those who are enrolled in Medicare, Medicaid, or any other federal or state healthcare programs.

Medicare Part D enrollees who qualify for the Extra Help program pay between $0-$8 per month. Around 80% of people who dont qualify for Extra Help should expect to pay in the range of $0-$50 per month for their Linzess prescription.

Get your Linzess medication for only $49 per month

Is Linzess A Controlled Substance

No, Linzess is not a controlled substance. A controlled substance is a medication that the government regulates, typically because of the risk of misuse or dependence.

Misuse refers to taking a medication in a different way than how it was prescribed. Dependence occurs when your body becomes used to taking a drug, and then you need it to function as you usually do.

Linzess is not known to cause misuse or dependence.

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Should I Expect Nausea With Linzess

Nausea was not a side effect reported in clinical trials of people who took Linzess. However, nausea has been reported since the drug came on the market.

You may be nauseous due to the constipation you experience from IBS-C or CIC. Nausea is a symptom of constipation.

Your doctor may be able to suggest possible treatments for any nausea you have.

Drugs That Have To Be Dispensed In Orginal Bottle/packaging

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trailerpark said:I’m looking for a good chart for retail that lists all the drugs that need to be dispensed in original bottle/packaging. I was browsing Pharmacist Letter and couldn’t find a good list, just an article about why Pradaxa and other drugs need to stay in their original containers. Anyone have a good chart or resource that has what I’m looking for?


unit-of-use bottles

  • NDC 0597-0135-54 Unit of use bottle of 60 capsules
  • NDC 0597-0135-60 Blister package containing 60 capsules

AGGRENOX capsules are supplied in unit-of-use bottles of 60 capsules .Store at 25°C excursions permitted to 15°-30°C . Protect from excessive moisture.

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trailerpark said:I’m looking for a good chart for retail that lists all the drugs that need to be dispensed in original bottle/packaging. I was browsing Pharmacist Letter and couldn’t find a good list, just an article about why Pradaxa and other drugs need to stay in their original containers. Anyone have a good chart or resource that has what I’m looking for?

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