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GLOPERBA- colchicine solution


  1. Revised:
  2. Patient Information
  3. What Is Gloperba?
  4. Do Not Take Gloperba If You:
  5. About All Of Your Medical Conditions, Including If You:
  6. Especially Tell Your Healthcare Provider If You Take:
  7. How Should I Take Gloperba?
  8. What Should I Avoid While Taking Gloperba?
  9. Gloperba Can Cause Serious Side Effects, Including:
  10. The Most Common Side Effects Of Gloperba Include:
  11. How Should I Store Gloperba?
  12. Inactive Ingredients:
  13. Manufactured For:

Revised: 

2/2019

Patient Information 

Advise the patient to read the FDA-approved patient labeling (Medication Guide).

Dosing Instructions

Patients should be advised to take GLOPERBA as prescribed, even if they are feeling better. Patients should not alter the dose or discontinue treatment without consulting with their doctor. If a dose of GLOPERBA is missed, take the dose as soon as possible and then return to the normal dosing schedule. However, if a dose is skipped the patient should not double the next dose.

Advise patients and caregivers to measure GLOPERBA with an accurate milliliter measuring device. A household teaspoon is not an accurate measuring device. Advise patients and caregivers to ask their pharmacist to recommend an appropriate measuring device and for instructions for measuring the correct dose.

Fatal Overdose

Instruct patient that fatal overdoses, both accidental and intentional, have been reported in adults and children who have ingested colchicine. GLOPERBA should be kept out of the reach of children.

Blood Dyscrasias

Patients should be informed that bone marrow depression with agranulocytosis, aplastic anemia and thrombocytopenia may occur with GLOPERBA.

Drug and Food Interactions

Advise patients that many drugs or other substances may interact with GLOPERBA and some interactions could be fatal. Therefore, patients should report to their healthcare provider all of the current medications they are taking and check with their healthcare provider before starting any new medications, including short-term medications such as antibiotics. Patients should also be advised to report the use of nonprescription medication or herbal products. Grapefruit and grapefruit juice may also interact and should not be consumed during GLOPERBA treatment.

Neuromuscular Toxicity

Patients should be informed that muscle pain or weakness, tingling or numbness in fingers or toes may occur with GLOPERBA alone or when it is used with certain other drugs. Patients developing any of these signs or symptoms must discontinue GLOPERBA and

GLOPERBA can cause serious side effects or death if levels of GLOPERBA are too high in your body.

  • Taking certain medicines with GLOPERBA can cause your level of GLOPERBA to be too high, especially if you have kidney or liver problems.
  • Tell your healthcare provider about all your medical conditions, including if you have kidney or liver problems. Your dose of GLOPERBA may need to be changed.
  • Tell your healthcare provider about all the medicines you take, including prescription and nonprescription medicines, vitamins and herbal supplements.
  • Medicines that you take for a short period of time, such as antibiotics, can interact with GLOPERBA and cause serious side effects or death.
  • Talk to your healthcare provider or pharmacist before taking any new medicine.

What Is Gloperba? 



GLOPERBA is a prescription medicine used to prevent gout flares in adults.

It is not known if GLOPERBA is safe and effective for the treatment of sudden (acute) gout flares.

GLOPERBA is not a pain medicine, and it should not be taken to treat pain related to other medical conditions unless specifically prescribed for those conditions.

It is not known if GLOPERBA is safe and effective in children.

Do Not Take Gloperba If You: 

  • have liver or kidney problems and you take certain other medicines, unless directed to by a healthcare provider. Serious side effects, including death, have happened in people even when GLOPERBA is taken as directed.
  • have liver and kidney problems.
"Before taking GLOPERBA, tell your healthcare provider

About All Of Your Medical Conditions, Including If You: 

  • are pregnant or plan to become pregnant. It is not known if GLOPERBA can harm your unborn baby.
  • are breastfeeding or plan to breastfeed. GLOPERBA can pass into your breast milk. Talk to your healthcare provider about the best way to feed your baby if you take GLOPERBA.
  • are amalewith a female partner who can become pregnant. Receiving treatment with GLOPERBA may be related to infertility in some men that is reversible when treatment is stopped.
Tell your healthcare provider about all the medicines you take, including prescription, over-the-counter medicines, vitamins, and herbal supplements.
  • Using GLOPERBA with certain other medicines can affect each other, causing serious side effects or death.
  • Do nottake GLOPERBA with other medicines unless your healthcare provider tells you to.
  • Know the medicines you take. Keep a list of your medicines with you to show your healthcare provider and pharmacist each time you get a new medicine.

Especially Tell Your Healthcare Provider If You Take: 


medicines that may affect how your liver works (CYP3A4 inhibitors)

a medicine called cyclosporine (Noeral, Gengraf, Sandimmune)

cholesterol lowering medicines, or

antibioticsAsk your healthcare provider or pharmacist if you are not sure if you take any of the medicines listed above. This is not a complete list of all the medicines that can affect GLOPERBA.

How Should I Take Gloperba? 

  • Take GLOPERBA exactly as your healthcare provider tells you to take it. If you are not sure about your dosing, call your healthcare provider.
  • Measure GLOPERBA with an accurate milliliter measuring device.A household teaspoon is not an accurate measuring device.Ask your pharmacist to recommend a measuring device and for instructions on how to measure the correct dose.
  • GLOPERBA can be taken with or without food.
  • If you take too much GLOPERBA, call your healthcare provider or go to the nearest hospital emergency room right away.
  • Do not stop taking GLOPERBA unless your healthcare provider tells you.
  • If you miss a dose of GLOPERBA, take it as soon as you remember. If it is almost time for your next dose, skip the missed dose. Take the next dose at your regular time. Do not take 2 doses at the same time.

What Should I Avoid While Taking Gloperba? 



Avoid eating grapefruit or drinking grapefruit juice while taking GLOPERBA. It can increase your chances of having serious side effects.

Gloperba Can Cause Serious Side Effects, Including: 


"
  • Blood problems.Blood problems have happened in some people taking GLOPERBA. Get medical help right away if you have any of these symptoms:
pale or gray color to your lips, tongue or palms of your hands.feel weak or tiredunusual bleeding or bruisingincreased infections
  • Muscle weakness (neuromuscular toxicity). Muscle weakness has happened in some people taking GLOPERBA. Get medical help right away if you have any of these symptoms:
muscle weakness or painnumbness or tingling in your fingers or toes

The Most Common Side Effects Of Gloperba Include: 

diarrheanauseavomitingabdominal (stomach) painTell your healthcare provider if you have any side effect that bothers you or that does not go away.

These are not all of the possible side effects of GLOPERBA. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

How Should I Store Gloperba? 

  • Store GLOPERBA between 20 -25 C (68 -77 F); excursions permitted to 15 -30 C (59 -86 F). [

    Active Ingredient: colchicine

Inactive Ingredients: 

benzyl alcohol, FD&C Red No. 40, artificial cherry flavor, anhydrous citric acid, dibasic sodium phosphate, glycerin, propylene glycol, sucralose, xanthan gum and purified water.RxONLY

Manufactured For: 


Avion Pharmaceuticals

Alpharetta, GA 30005

For more information, call 1-888-61-AVIONThis Medication Guide has been approved by the U.S Food and Drug AdministrationIssued: 7/2019



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