Patient information on Amitiza (Lubiprostone)

Manufactured by: Sucampo Pharmaceuticals, Inc.

What is Amitiza used for? You may be prescribed Amitiza if you develop Irritable bowel syndrome, in which you experience anguish pain in the stomach which also causes chronic constipation and leads to piles /hemorrhoids development.

What is the dose structure and intensity (quality) of Amitiza? It is available as gelatin capsules in the potency of 8 mcg and 24 mcg.

What knowledge should you have about Amitiza?

  • Altogether read the medication aide provided before taking the drug.
  • You can take the medication on a vacant or full stomach, even in the middle of the meal.
  • It is for use by both the genders.
  • Do consult your doctor regarding Amitiza if you are breast feeding your child, because of the reason that Amitiza can cause severe diarrhea in babies which could prove harmful.
  • You may experience nausea after taking this drug. Consult your doctor if nausea worsens or persist.
  • Instantly look for therapeutic help on encountering any sort of hypersensitive response to this drug.
  • The helpful regimen with Amitiza can bring about extreme loose bowels in many patients. On encountering such condition you ought to end the medication and counsel your doctor and use a lot of liquids to prevent excessive loss of water from your body.
  • You can also experience tautness in the chest and feel breath shortness after an hour of ingesting Amitiza. Consult your doctor if the side effect continues and becomes troublesome or inconvenient.
  • Do not give Amitiza to children.

Dosing Considerations: as prescribed by the doctor.

Instructions to use the medicine:

  • Always take Amitiza according to the recommended dosage to avoid unwanted effects of increased dose and vice versa.
  • You should administer Amitiza’s capsule as a whole with food or a full glass of milk/water.
  • Avoid exposing the capsules to heat and moisture.

Contra-indications and precautions:

Amitiza should never be used in;

  • If allergic to the product
  • Children
  • Liver and heart failure
  • Diarrhea
  • GI blockade

What are the adverse impacts of the medication?

Amitiza can cause one or several of the following side effects;

General disorders: fluid retention, fatigue, pain in the chest region.

Nervous system disorders: Headache and Dizziness.

Respiratory-related: shortness of breath.

Gastrointestinal associated disorders: nausea, vomiting, watery stools, pain in the abdomen, dryness in the oral cavity, indigestion.

Post-marketing reports include loss of consciousness, hypersensitivity reactions, general weakness, fastened heartbeat, weakened muscles.

Are there any drug-interactions present with Amitiza?

No in vivo drug–drug interaction studies have been executed with Amitiza. Based on the existing data, no protein binding–mediated drug interactions of clinical impact are present. Use of Amitiza along with diphenylheptane opioids may reduce the effective working of Amitiza in the body.

 Could this medication be utilized by particular populaces?

  • In pregnancy: lubiprostone has a place with the classification C. Animal tests have proposed that when lubiprostone was given in pregnant females, it brought about the damage of embryos. Amitiza in such situation is only used when the potential value of lubiprostone exceeds the risk to the fetus.
  • In nursing mothers: infants being breast fed by mothers taking Amitiza ought to be monitored closely for diarrhea.
  • In pediatrics: harmful to children.
  • In geriatrics: it can be safely used in elderly patients.

Pharmacology of Amitiza:

Mode of action: It is a locally acting chloride channel activator and it increases the fluid secretion from the intestines and the motility of intestine by locally acting at the apical portion of the intestine.

Pharmacokinetics of this drug:

Absorption: it shows a low systemic absorption with peak plasma time of 1 hour.

Distribution: 94% of the proteins present in human plasma get bound to this drug.

Metabolism and Elimination: its metabolism is via a group of enzymes (carbonyl anhydrase) present in the stomach and jejunum (portion between the duodenum and ileum of the GI tract). The real course of discharge is urine. Less than 1% of the controlled medication is disposed of through the feces.

In varying population: Amitiza is safe in patients having a mild liver injury. It is also safe in renal failure.

Toxicology profile of this drug: Tumor in testes of male rats and cancerous hepatic cells were found in female rats during animal testing. It did not show any mutagenicity in animal subjects and the reproductive systems were not affected either.

Before using Amitiza: you should always tell your doctor about;

  • If has stones in the gall bladder.
  • If a hernia.
  • About gastric problems.
  • About any current or previous liver injuries.
  • If you are pregnant
  • If you are nursing your child.

Components of the capsule:

Amitiza contains lubiprostone, dyes ferric oxide and titanium dioxide, medium-chain triglycerides, sorbitol, purified water, dyes FD&C Red #40 and D&C, Yellow #10, and gelatin.

 

 

 

 

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