What are the uses of Colcrys oral medication? What are the side effects of Colcrys? How do Colcrys interactions work? What are the warnings and dosing recommendations for Colcrys.

Overview of Colcrys Oral Medication

Colcrys is an oral medication used to treat and prevent certain types of inflammatory conditions, such as gout attacks and familial Mediterranean fever. This medication works by reducing inflammation and pain associated with these conditions. It is important to carefully follow the dosing instructions provided by your healthcare provider to ensure the safe and effective use of Colcrys.

Colcrys Uses

Colcrys has several approved uses, including:

• Treating acute gout attacks: Colcrys can be used to treat the sudden onset of pain, swelling, and inflammation associated with gout attacks. The recommended dose is 1.2 mg at the first sign of an attack, followed by 0.6 mg one hour later, with a maximum dose of 1.8 mg over a 1-hour period.
• Preventing gout attacks: Colcrys can be used to help prevent future gout attacks, with the dosage determined by your healthcare provider.
• Treating pericarditis: Colcrys can be used to help manage the inflammation and pain associated with pericarditis, a condition affecting the pericardium (the protective sac surrounding the heart).
• Preventing attacks of familial Mediterranean fever: Colcrys can be used to help prevent the recurrent episodes of fever, pain, and inflammation associated with familial Mediterranean fever, a genetic disorder. The usual dose is 1.2 to 2.4 mg daily, taken once or divided into two doses.

Colcrys Side Effects

Colcrys can cause various side effects, including:

• Gastrointestinal issues: Nausea, vomiting, diarrhea, and abdominal pain are common side effects.
• Muscle weakness or pain: Colcrys can cause myopathy (muscle weakness) or rhabdomyolysis (breakdown of muscle fibers).
• Bone marrow suppression: Colcrys can suppress the production of blood cells, leading to a decreased number of white blood cells, red blood cells, and platelets.
• Nervous system effects: Headache, dizziness, and tremors have been reported.
• Allergic reactions: Skin rashes, hives, and swelling may occur in some individuals.

It is important to report any side effects to your healthcare provider, as they may need to adjust the dosage or discontinue the medication.

Colcrys Interactions

Colcrys can interact with various medications, potentially increasing the risk of side effects. Some of the known interactions include:

• P-glycoprotein inhibitors: Medications that inhibit the P-glycoprotein transporter, such as cyclosporine, clarithromycin, and ketoconazole, can increase the levels of Colcrys in the body, leading to an increased risk of side effects.
• CYP3A4 inhibitors: Drugs that inhibit the CYP3A4 enzyme, like certain antifungals, antibiotics, and HIV medications, can also increase Colcrys levels and the risk of side effects.
• Grapefruit and grapefruit juice: Consuming grapefruit or grapefruit juice while taking Colcrys can increase the drug’s concentration in the body, potentially leading to adverse effects.

It is important to inform your healthcare provider about all the medications, supplements, and herbal products you are taking to ensure the safe and effective use of Colcrys.

Colcrys Warnings and Precautions

Colcrys should be used with caution in the following situations:

• Renal or hepatic impairment: Patients with kidney or liver problems may require a lower dosage of Colcrys to prevent the risk of serious side effects.
• Elderly patients: Older adults may be more susceptible to the adverse effects of Colcrys, and the dosage may need to be adjusted accordingly.
• Pregnancy and breastfeeding: The safety of Colcrys during pregnancy and breastfeeding has not been fully established, and it should only be used if the potential benefits outweigh the risks.
• Concurrent use of certain medications: As mentioned earlier, Colcrys can interact with various drugs, and these interactions must be carefully managed to prevent complications.

Colcrys Dosing Guidelines

The dosage of Colcrys can vary depending on the condition being treated and the individual patient’s response to the medication. It is essential to follow the specific dosing instructions provided by your healthcare provider. Some general dosing guidelines include:

• Gout attacks: 1.2 mg at the first sign of an attack, followed by 0.6 mg one hour later, with a maximum dose of 1.8 mg over a 1-hour period.
• Gout prophylaxis: Dosage as determined by your healthcare provider.
• Pericarditis: Dosage as determined by your healthcare provider.
• Familial Mediterranean fever: 1.2 to 2.4 mg daily, taken once or divided into two doses.

Regardless of the condition being treated, it is crucial to take Colcrys exactly as prescribed and not exceed the recommended dosage, as this can increase the risk of side effects.

Conclusion

Colcrys is a versatile medication used to treat and prevent various inflammatory conditions, including gout attacks, pericarditis, and familial Mediterranean fever. It is essential to follow the dosing instructions provided by your healthcare provider and to be aware of potential side effects and drug interactions. By using Colcrys as directed, patients can effectively manage their condition and reduce the risk of complications.

Colcrys Oral: Uses, Side Effects, Interactions, Pictures, Warnings & Dosing

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

Take this medication by mouth with or without food, exactly as directed by your doctor. Dosing recommendations vary widely and may be different from the following recommendations. Taking more than the recommended dose may not increase this drug’s effectiveness and may increase your risk for side effects. Ask your doctor or pharmacist for more details.

If you are taking this medication to treat a gout attack, carefully follow the directions given by your doctor. This medication works best if you take it at the first sign of an attack. The recommended dose is 1.2 milligrams at the first sign of an attack, followed by 0.6 milligrams one hour later. The maximum recommended dose is 1.8 milligrams taken over a 1-hour period. Ask your doctor ahead of time about how soon you can repeat treatment with this medication if you have another gout attack.

If you are taking this medication to prevent gout attacks or for pericarditis, ask your doctor about the dose and schedule you should follow. Carefully follow your doctor’s directions.

If you are taking this medication to prevent attacks of pain caused by familial Mediterranean fever, the usual dose is 1.2 to 2.4 milligrams daily. The total dose may be taken once daily or divided into two doses a day. Your doctor may need to adjust your dose to control your symptoms or if you have side effects.

The dosage is based on your medical condition, other drugs/foods you may be taking, and response to treatment. To reduce your risk for serious side effects, do not increase your dose, take it more frequently, or take it for a longer time than directed by your doctor. Serious side effects may occur even at usual prescribed doses.

If your doctor directs you to take colchicine regularly, use it regularly to get the most benefit from it. To help you remember, take it at the same time(s) each day.

Avoid eating grapefruit or drinking grapefruit juice while being treated with this medication unless your doctor instructs you otherwise. Grapefruit can increase the amount of certain medications in your bloodstream. Consult your doctor or pharmacist for more details.

If you are taking this medication to treat symptoms due to familial Mediterranean fever, tell your doctor if your condition does not improve or if it worsens.

Colchicine Oral: Uses, Side Effects, Interactions, Pictures, Warnings & Dosing

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

Take this medication by mouth with or without food, exactly as directed by your doctor. Dosing recommendations vary widely and may be different from the following recommendations. Taking more than the recommended dose may not increase this drug’s effectiveness and may increase your risk for side effects. Ask your doctor or pharmacist for more details.

If you are taking this medication to treat a gout attack, carefully follow the directions given by your doctor. This medication works best if you take it at the first sign of an attack. The recommended dose is 1.2 milligrams at the first sign of an attack, followed by 0.6 milligrams one hour later. The maximum recommended dose is 1.8 milligrams taken over a 1-hour period. Ask your doctor ahead of time about how soon you can repeat treatment with this medication if you have another gout attack.

If you are taking this medication to prevent gout attacks or for pericarditis, ask your doctor about the dose and schedule you should follow. Carefully follow your doctor’s directions.

If you are taking this medication to prevent attacks of pain caused by familial Mediterranean fever, the usual dose is 1.2 to 2.4 milligrams daily. The total dose may be taken once daily or divided into two doses a day. Your doctor may need to adjust your dose to control your symptoms or if you have side effects.

The dosage is based on your medical condition, other drugs/foods you may be taking, and response to treatment. To reduce your risk for serious side effects, do not increase your dose, take it more frequently, or take it for a longer time than directed by your doctor. Serious side effects may occur even at usual prescribed doses.

If your doctor directs you to take colchicine regularly, use it regularly to get the most benefit from it. To help you remember, take it at the same time(s) each day.

Avoid eating grapefruit or drinking grapefruit juice while being treated with this medication unless your doctor instructs you otherwise. Grapefruit can increase the amount of certain medications in your bloodstream. Consult your doctor or pharmacist for more details.

If you are taking this medication to treat symptoms due to familial Mediterranean fever, tell your doctor if your condition does not improve or if it worsens.

Colchicine: Uses, Interactions, Mechanism of Action

Colchicine tablets or capsules

What is this medicine?

COLCHICINE (KOL chi seen) is used to prevent or treat attacks of acute gout or gouty arthritis. This medicine is also used to treat familial Mediterranean fever.

This medicine may be used for other purposes; ask your health care provider or pharmacist if you have questions.

COMMON BRAND NAME(S): Colcrys, MITIGARE

What should I tell my health care provider before I take this medicine?

They need to know if you have any of these conditions:

• kidney disease
• liver disease
• an unusual or allergic reaction to colchicine, other medicines, foods, dyes, or preservatives
• pregnant or trying to get pregnant
• breast-feeding

How should I use this medicine?

Take this medicine by mouth with a full glass of water. Follow the directions on the prescription label. You can take it with or without food. If it upsets your stomach, take it with food. Take your medicine at regular intervals. Do not take your medicine more often than directed.

A special MedGuide will be given to you by the pharmacist with each prescription and refill. Be sure to read this information carefully each time.

Talk to your pediatrician regarding the use of this medicine in children. While this drug may be prescribed for children as young as 4 years old for selected conditions, precautions do apply.

Patients over 65 years old may have a stronger reaction and need a smaller dose.

Overdosage: If you think you have taken too much of this medicine contact a poison control center or emergency room at once.

NOTE: This medicine is only for you. Do not share this medicine with others.

What if I miss a dose?

If you miss a dose, take it as soon as you can. If it is almost time for your next dose, take only that dose. Do not take double or extra doses.

What may interact with this medicine?

Do not take this medicine with any of the following medications:

• certain antivirals for HIV or hepatitis

This medicine may also interact with the following medications:

• certain antibiotics like erythromycin or clarithromycin
• certain medicines for blood pressure, heart disease, irregular heart beat
• certain medicines for cholesterol like atorvastatin, lovastatin, and simvastatin
• certain medicines for fungal infections like ketoconazole, itraconazole, or posaconazole
• cyclosporine
• grapefruit or grapefruit juice

This list may not describe all possible interactions. Give your health care provider a list of all the medicines, herbs, non-prescription drugs, or dietary supplements you use. Also tell them if you smoke, drink alcohol, or use illegal drugs. Some items may interact with your medicine.

What should I watch for while using this medicine?

Visit your healthcare professional for regular checks on your progress. Tell your healthcare professional if your symptoms do not start to get better or if they get worse.

You should make sure you get enough vitamin B12 while you are taking this medicine. Discuss the foods you eat and the vitamins you take with your healthcare professional.

This medicine may increase your risk to bruise or bleed. Call you healthcare professional if you notice any unusual bleeding.

What side effects may I notice from receiving this medicine?

Side effects that you should report to your doctor or health care professional as soon as possible:

• allergic reactions like skin rash, itching or hives, swelling of the face, lips, or tongue
• low blood counts – this medicine may decrease the number of white blood cells, red blood cells, and platelets. You may be at increased risk for infections and bleeding
• pain, tingling, numbness in the hands or feet
• severe diarrhea
• signs and symptoms of infection like fever; chills; cough; sore throat; pain or trouble passing urine
• signs and symptoms of muscle injury like dark urine; trouble passing urine or change in the amount of urine; unusually weak or tired; muscle pain; back pain
• unusual bleeding or bruising
• unusually weak or tired
• vomiting

Side effects that usually do not require medical attention (report these to your doctor or health care professional if they continue or are bothersome):

• mild diarrhea
• nausea
• stomach pain

This list may not describe all possible side effects. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Where should I keep my medicine?

Keep out of the reach of children.

Store at room temperature between 15 and 30 degrees C (59 and 86 degrees F). Keep container tightly closed. Protect from light. Throw away any unused medicine after the expiration date.

NOTE: This sheet is a summary. It may not cover all possible information. If you have questions about this medicine, talk to your doctor, pharmacist, or health care provider.

Colcrys | Healthgrades | (colchicine tablet, film coated)

Brand Name: Colcrys

Generic Name: COLCHICINE

Drug Type: HUMAN PRESCRIPTION DRUG

Route: ORAL

Dosage Form: TABLET, FILM COATED

Data Current As Of: 2019-02-11

COLCRYS (colchicine, USP) tablets are indicated for prophylaxis and the treatment of acute gout flares.

• Prophylaxis of Gout Flares:
  COLCRYS is indicated for prophylaxis of gout flares.
• Treatment of Gout Flares:
  COLCRYS tablets are indicated for treatment of acute gout flares when taken at the first sign of a flare.

familial mediterranean fever (fmf)

COLCRYS (colchicine, USP) tablets are indicated in adults and children 4 years or older for treatment of familial Mediterranean fever (FMF).

Tolerance, abuse or dependence with colchicine has not been reported.

patient counseling information

See FDA-approved Medication Guide.

Patients should be advised to take COLCRYS 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 COLCRYS is missed:

• For treatment of a gout flare when the patient is not being dosed for prophylaxis, take the missed dose as soon as possible.
• For treatment of a gout flare during prophylaxis, take the missed dose immediately, wait 12 hours, then resume the previous dosing schedule.
• For prophylaxis without treatment for a gout flare, or FMF, 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.

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

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

Patients should be advised that many drugs or other substances may interact with COLCRYS 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, particularly 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 COLCRYS treatment.

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

MEDICATION GUIDE

COLCRYS
(KOL-kris)

(colchicine) tablets

Read the Medication Guide that comes with COLCRYS before you start taking it and each time you get a refill. There may be new information. This Medication Guide does not take the place of talking to your healthcare provider about your medical condition or treatment. You and your healthcare provider should talk about COLCRYS when you start taking it and at regular checkups.

What is the most important information that I should know about COLCRYS?

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

• Taking certain medicines with COLCRYS can cause your level of COLCRYS 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 COLCRYS may need to be changed.
• Tell your healthcare provider about all the medicines you take, including prescription and nonprescription medicines, vitamins and herbal supplements.
• Even medicines that you take for a short period of time, such as antibiotics, can interact with COLCRYS and cause serious side effects or death.
• Talk to your healthcare provider or pharmacist before taking any new medicine.
• Especially tell your healthcare provider if you take:

Ask 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 interact with COLCRYS.

• Know the medicines you take. Keep a list of them and show it to your healthcare provider and pharmacist when you get a new medicine.
• Keep COLCRYS out of the reach of children.

What is COLCRYS?

COLCRYS is a prescription medicine used to:

• prevent and treat gout flares in adults
• treat familial Mediterranean fever (FMF) in adults and children age 4 or older

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

Who should not take COLCRYS?

Do not take COLCRYS if you have liver or kidney problems and you take certain other medicines. Serious side effects, including death, have been reported in these patients even when taken as directed. See “What is the most important information that I should know about COLCRYS?”

What should I tell my healthcare provider before starting COLCRYS?

See “What is the most important information that I should know about COLCRYS?”

Before you take COLCRYS, tell your healthcare provider about all your medical conditions, including if you:

• have liver or kidney problems.
• are pregnant or plan to become pregnant. It is not known if COLCRYS will harm your unborn baby. Talk to your healthcare provider if you are pregnant or plan to become pregnant.
• are breastfeeding or plan to breastfeed. COLCRYS passes into your breast milk. You and your healthcare provider should decide if you will take COLCRYS or breastfeed. If you take COLCRYS and breastfeed, you should talk to your child’s healthcare provider about how to watch for side effects in your child.

Tell your healthcare provider about all the medicines you take, including ones that you may only be taking for a short time, such as antibiotics. See “What is the most important information that I should know about COLCRYS?” Do not start a new medicine without talking to your healthcare provider.

Using COLCRYS with certain other medicines, such as cholesterol-lowering medications and digoxin, can affect each other, causing serious side effects. Your healthcare provider may need to change your dose of COLCRYS. Talk to your healthcare provider about whether the medications you are taking might interact with COLCRYS and what side effects to look for.

How should I take COLCRYS?

• Take COLCRYS exactly as your healthcare provider tells you to take it. If you are not sure about your dosing, call your healthcare provider.
• COLCRYS can be taken with or without food.
• If you take too much COLCRYS, go to the nearest hospital emergency room right away.
• Do not stop taking COLCRYS even if you start to feel better, unless your healthcare provider tells you.
• Your healthcare provider may do blood tests while you take COLCRYS.
• If you take COLCRYS daily and you miss a dose, then take it as soon as you remember. If it is almost time for your next dose, just skip the missed dose. Take the next dose at your regular time. Do not take two doses at the same time.
• If you have a gout flare while taking COLCRYS daily, report this to your healthcare provider.

What should I avoid while taking COLCRYS?

• Avoid eating grapefruit or drinking grapefruit juice while taking COLCRYS. It can increase your chances of getting serious side effects.

What are the possible side effects of COLCRYS?

COLCRYS can cause serious side effects or even cause death. See “What is the most important information that I should know about COLCRYS?”

Get medical help right away if you have:

• Muscle weakness or pain
• Numbness or tingling in your fingers or toes
• Unusual bleeding or bruising
• Increased infections
• Feel weak or tired
• Pale or gray color to your lips, tongue or palms of your hands
• Severe diarrhea or vomiting

Gout Flares: The most common side effect of COLCRYS in people who have gout flares is diarrhea.

FMF: The most common side effects of COLCRYS in people who have FMF are abdominal pain, diarrhea, nausea and vomiting.

Tell 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 COLCRYS. For more information, ask your healthcare provider or pharmacist.

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 COLCRYS?

• Store COLCRYS at room temperature between 68°F and 77°F (20°C and 25°C).
• Keep COLCRYS in a tightly closed container.
• Keep COLCRYS out of the light.

Keep COLCRYS and all medicines out of the reach of children.

General Information about COLCRYS

Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use COLCRYS for a condition for which it was not prescribed. Do not give COLCRYS to other people, even if they have the same symptoms that you have. It may harm them. This Medication Guide summarizes the most important information about COLCRYS. If you would like more information, talk with your healthcare provider. You can ask your healthcare provider or pharmacist for information about COLCRYS that is written for healthcare professionals.

For more information, go to www.COLCRYS.com or call 1-877-825-3327.

What are the ingredients in COLCRYS?

Active Ingredient: colchicine.

Inactive Ingredients: carnauba wax, FD&C blue #2, FD&C red #40, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polydextrose, polyethylene glycol, pregelatinized starch, sodium starch glycolate, titanium dioxide and triacetin.

This Medication Guide has been approved by the U.S. Food and Drug Administration.

Distributed by:
Takeda Pharmaceuticals America, Inc.
Deerfield, IL 60015

Repackaged by:
Proficient Rx LP
Thousand Oaks, CA 91320

Revised: November 2012

COLCRYS is a trademark of Takeda Pharmaceuticals U. S.A., Inc., registered with the U.S. Patent and Trademark Office and used under license by Takeda Pharmaceuticals America, Inc.

All other trademarks are the property of their respective owners.

COL243 R1

PRINCIPAL DISPLAY PANEL – 0.6 mg Tablet Bottle Label

COLCRYS^®
(colchicine, USP) tablets
0.6 mg

PHARMACIST:
PLEASE DISPENSE WITH
MEDICATION GUIDE ATTACHED
Rx only

Why Is Colchicine So Expensive Now?

Prior to an FDA ban on unapproved colchicine products, the drugs cost $0.10 a pill. The only FDA-approved colchicine product costs $5 a pill.

As part of its Unapproved Drugs Initiative designed to remove unapproved drugs from the market by means of a “risk-based enforcement program” that concentrates on products that “pose the highest threat to public health and without imposing undue burdens on consumers, or unnecessarily disrupting the market,” the FDA in September 2010 ordered a halt to the manufacture, distribution, and marketing of unapproved single-ingredient oral colchicine. These medications were and are widely used for the daily prevention of gout and to treat acute gout flare-ups and Familial Mediterranean Fever.

Although the FDA acknowledged that “many single-ingredient oral colchicine products have been used by the medical community for decades,” because these medications had not received “mandatory modern-day FDA-approval” they rarely provided physicians and patients with the important safety data and information about drug interactions and dosing that are essential when making informed treatment decisions. Thus, the FDA action to ban their sale and distribution.

At the time of the announcement, Janet Woodcock, MD, director of FDA’s Center for Drug Evaluation and Research (CDER), said “The need for drugs to go through the FDA approval process is clearly demonstrated by our review of oral colchicine tablets. Without our safety review and proper drug labeling, the old standard of care would likely have continued, to the detriment of patients. ”

Noting that the unapproved colchicines medications had never been evaluated by the FDA and thus should not be viewed as generic drugs, which must be “approved by the FDA to assure that the approved generic drug products meet the same standards as the innovator drug,” Deborah M. Autor, director of CDER’s Office of Compliance, said “It is a priority for the FDA to get unapproved medications, such as older versions of single ingredient oral colchicine, either updated to conform to FDA’s current approval standards or off the market.”

One source for FDA-approved colchicine for gout

The only company manufacturing and marketing single-ingredient colchicine medications that applied for FDA approval and submitted its product to the rigorous testing and approval process was URL Pharma, maker of Colcrys.

Whereas many of the older, now-banned unapproved formulations of colchicine were available for mere pennies per pill, URL Pharma priced Colcrys at $5 per pill. The company said the price was justified by the high cost of approval testing, colchicine research, and physician education. As noted in this article in Slate, the company also was granted three years of market exclusivity for Colcrys for the treatment of gout, as well as a seven-year exclusivity period for Familial Mediterranean Fever.

The Slate piece also said that URL Pharma and the FDA defended the process by pointing out the safety concerns surrounding the use of unapproved colchicines (the article said “FDA officials have noted that colchicine had been associated with 117 non-overdose deaths, half of them involving an interaction between colchicine and the antibiotic clarithromycin”). Now, for the first time, the medication label for colchicine includes dosing and drug-interaction information. URL Pharma also contends that its research discovered that the drug was effective at much lower dosages than it was commonly prescribed at, another safety benefit from the approval process that also resulted in reduced side effects for patients.

Not everybody was happy with this turn of events

The removal of alternative colchicine products from the market, coupled with the high price of Colcrys, prompted physicians and patients alike to raise concerns over limited access to a drug that was relied on by thousands of patients. An advocacy letter sent to members by the American College of Rheumatology said that “the unanticipated increase in cost for colchicine has been extremely disappointing to all of us and our patients.” The letter also notified members that the ACR had contacted several manufacturers of unapproved colchicine “to encourage new drug applications for FDA approval of chronic gout” in the hopes that market competition URL Pharma and Colcrys would result in lower prices.

In response to these concerns, URL Pharma recently announced an “enhanced” version of the Colcrys Co-Pay Assistance Program, an initiative “designed to help patients save money on their health insurance co-payment for Colcrys. ” Under the revised program, patients with health insurance can use a coupon to obtain Colcrys for $15 per month (reduced from the previous price of $25 per month). In a “Colcrys Myths and Facts” resource on its website, the company also notes that “uninsured and Medicare Part D patients with household incomes of up to three times the federal poverty level (up to $66,000 per year for a family of four) can receive Colcrys free of charge. Uninsured and Medicare Part D patients with household incomes between three to four times the federal poverty level (up to $88,000 per year for a family of four) can receive Colcrys for $5 a month. Uninsured and Medicare Part D patients with household incomes between four to six times the federal poverty level (up to $132,000 per year for a family of four) can receive Colcrys for $25 a month.”

However, an article in Pharmacy Practice News said that some physicians are “worried that health insurance companies will limit or discontinue completely payments for Colcrys. ”Current ACR president David Borenstein, MD, said that “in practice many patient assistance programs are not extended by providers to patients and often are difficult for patients to maintain over time.”

HCPLive wants to know:

Do you recommend the use of oral colchicine for your patients with gout?

Has the removal from the market of cheaper prophylactic gout alternatives been a financial burden on patients?

Do support the FDA’s actions to remove unapproved drugs from the market in this manner?

Leave a comment below!

Memorial Sloan Kettering Cancer Center

This information from Lexicomp^® explains what you need to know about this medication, including what it’s used for, how to take it, its side effects, and when to call your healthcare provider.

Brand Names: US

Colcrys; Gloperba; Mitigare

Brand Names: Canada

EURO-Colchicine; JAMP-Colchicine; PMS-Colchicine; SANDOZ Colchicine

What is this drug used for?

• It is used to treat gout attacks.
• It is used to prevent gout attacks.
• It is used to treat familial Mediterranean fever.
• It may be given to you for other reasons. Talk with the doctor.

What do I need to tell my doctor BEFORE I take this drug?

• If you are allergic to this drug; any part of this drug; or any other drugs, foods, or substances. Tell your doctor about the allergy and what signs you had.
• If you have any of these health problems: Kidney disease or liver disease.

This is not a list of all drugs or health problems that interact with this drug.

This drug interacts with many other drugs. The chance of severe, life-threatening, or deadly side effects may be raised. Tell your doctor and pharmacist about all of your drugs (prescription or OTC, natural products, vitamins) and health problems. You must check to make sure that it is safe for you to take this drug with all of your drugs and health problems. Do not start, stop, or change the dose of any drug without checking with your doctor.

What are some things I need to know or do while I take this drug?

All products:

• Tell all of your health care providers that you take this drug. This includes your doctors, nurses, pharmacists, and dentists.
• Avoid grapefruit and grapefruit juice.
• Deadly overdoses have happened with this drug in adults and children. Keep away from children. Do not take more than you were told. If this drug is taken by accident, call your poison control center or get medical care right away.
• Sperm problems have happened while taking this drug. This may affect being able to father a child. This may go back to normal after the drug is stopped. If you have questions, talk with the doctor.
• If you are 65 or older, use this drug with care. You could have more side effects.
• Tell your doctor if you are pregnant, plan on getting pregnant, or are breast-feeding. You will need to talk about the benefits and risks to you and the baby.

Capsules and oral solution:

• This drug is not approved to treat gout attacks. If you have a gout attack while taking this drug, talk with your doctor.

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.
• Numbness or tingling in the hands or feet.
• Pale skin.
• Very bad muscle problems have happened with this drug. This can also lead to kidney problems. Tell your doctor if you have muscle pain or weakness, especially if you feel very tired or weak or have a fever. Tell your doctor if you are not able to pass urine or you have a change in how much urine is passed.
• Low blood cell counts have happened with this drug. If blood cell counts get very low, this can lead to bleeding problems, infections, or anemia. Call your doctor right away if you have signs of infection like fever, chills, or sore throat; any unexplained bruising or bleeding; or if you feel very tired or weak.

What are some other side effects of this drug?

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:

• Stomach pain or diarrhea.
• Upset stomach or throwing up.

These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.

You may report side effects to your national health agency.

You may report side effects to the FDA at 1-800-332-1088. You may also report side effects at https://www.fda.gov/medwatch.

How is this drug best taken?

Use this drug as ordered by your doctor. Read all information given to you. Follow all instructions closely.

All products:

• Take with or without food.

Liquid (solution):

• Measure liquid doses carefully. Use the measuring device that comes with this drug. If there is none, ask the pharmacist for a device to measure this drug.
• Do not use a household teaspoon or tablespoon to measure this drug. Doing so could lead to the dose being too high.

What do I do if I miss a dose?

All products:

• Take a missed dose as soon as you think about it.
• If it is close to the time for your next dose, skip the missed dose and go back to your normal time.
• Do not take 2 doses at the same time or extra doses.

Tablets:

• To treat a gout attack, this drug is taken on an as needed basis.

How do I store and/or throw out this drug?

Tablets and capsules:

• Store at room temperature protected from light. Store in a dry place. Do not store in a bathroom.

Liquid (solution):

• Store at room temperature in a dry place. Do not store in a bathroom.

All products:

• Keep lid tightly closed.
• Keep all drugs in a safe place. Keep all drugs out of the reach of children and pets.
• Throw away unused or expired drugs. Do not flush down a toilet or pour down a drain unless you are told to do so. Check with your pharmacist if you have questions about the best way to throw out drugs. There may be drug take-back programs in your area.

General drug facts

• If your symptoms or health problems do not get better or if they become worse, call your doctor.
• Do not share your drugs with others and do not take anyone else’s drugs.
• Some drugs may have another patient information leaflet. If you have any questions about this drug, please talk with your doctor, nurse, pharmacist, or other health care provider.
• This drug comes with an extra patient fact sheet called a Medication Guide. Read it with care. Read it again each time this drug is refilled. If you have any questions about this drug, please talk with the doctor, pharmacist, or other health care provider.
• If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

Consumer Information Use and Disclaimer

This information should not be used to decide whether or not to take this medicine or any other medicine. Only the healthcare provider has the knowledge and training to decide which medicines are right for a specific patient. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about this medicine. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to this medicine. This information is not specific medical advice and does not replace information you receive from the healthcare provider. You must talk with the healthcare provider for complete information about the risks and benefits of using this medicine. The use of this information is governed by the Lexicomp End User License Agreement, available at https://www.wolterskluwer.com/en/solutions/lexicomp/about/eula.

Last Reviewed Date

2019-12-31

Copyright

© 2021 UpToDate, Inc. and its affiliates and/or licensors. All rights reserved.

Colchicine: Pediatric Medication | Memorial Sloan Kettering Cancer Center

This document, provided by Lexicomp ^® , contains all the information you need to know about the drug, including the indications, route of administration, side effects and when you should contact your healthcare provider.

Trade names: USA

Colcrys; Gloperba; Mitigare

Trade names: Canada

EURO-Colchicine; JAMP-Colchicine; PMS-Colchicine; SANDOZ Colchicine

What is this drug used for?

• Used for the treatment and prevention of gout.
• Used to treat familial Mediterranean fever.
• This drug can be given to children for other indications. Consult your doctor.

What do I need to tell my doctor BEFORE my child takes this drug?

• If your child is allergic to this drug, any of its ingredients, other drugs, foods, or substances. Tell your doctor about the allergy and how your child has it.
• If your child has any of the following: kidney disease or liver disease.

This list of drugs and diseases that may be adversely associated with this drug is not exhaustive.

This drug can interact with many other drugs. The risk of serious, life-threatening, or life-threatening side effects may be increased. Talk to your doctor or pharmacist about all medications your child is taking (prescription, over-the-counter, natural products, and vitamins) and any health concerns.You need to make sure this drug is safe for your child’s illness and in combination with other drugs the child is already taking. You should not start, stop, or change the dosage of any drug your child is taking without talking to the doctor.

What do I need to know or do while my child is taking this drug?

• Tell all health care providers for your child that your child is taking this drug.These are your child’s doctors, nurses, pharmacists and dentists.
• Do not give your child grapefruit or grapefruit juice.
• Fatal overdoses in adults and children have happened with this drug. Keep out of the reach of children. Do not exceed the maximum recommended dose. If this drug is mistakenly taken, call a poison control center or get medical help right away.
• Semen problems have been reported with this drug.This can adversely affect a man’s ability to conceive. This phenomenon may be reversible after discontinuation of the drug. If you have any questions, consult your doctor.

If your daughter is pregnant or breastfeeding:

• Consult a doctor if your daughter is pregnant, pregnant, or breastfeeding. The benefits and risks for your daughter and her child will need to be discussed.

Capsules and oral solution:

• This drug is not approved for the treatment of gout attacks. If your child develops a gout attack while using this drug, talk to your doctor.

What side effects should I report to my child’s healthcare provider right away?

WARNING / CAUTION: Although rare, this drug can cause very serious and sometimes deadly side effects in some people.Call your child’s doctor right away or get medical attention if your child has any of the following signs or symptoms that could be associated with a very bad side effect:

• Signs of an allergic reaction such as rash, hives, itching, reddened and swollen skin with blistering or scaling, possibly associated with fever, wheezing or wheezing, tightness in the chest or throat, difficulty breathing, swallowing or speaking, unusual hoarseness, swelling in the mouth, face, lips, tongue, or throat.
• Numbness or tingling in the palms or feet.
• Pale skin.
• Serious muscle problems may happen while taking this drug. It can also lead to impaired kidney function. If your child develops muscle pain or weakness, especially if you feel very tired, weak or feverish, tell your doctor. Talk to your doctor if your child has difficulty urinating or changes in the amount of urine that is passed.
• Cases of decreased blood cell count have been reported during treatment with this drug. A marked decrease in the number of blood cells can lead to bleeding, infection, or anemia. See your doctor right away if your child develops symptoms of an infection, such as high fever, chills, or sore throat; any unexplained bruising or bleeding; or when you are very tired or weak.

What are some other side effects of this drug?

Any drug can have side effects.However, many people have little or no side effects. Call your child’s doctor or get medical help if any of these or other side effects bothers your child or does not go away:

• Abdominal pain or diarrhea.
• Nausea or vomiting.

This list of potential side effects is not exhaustive. If you have any questions about side effects, talk to your child’s doctor.Talk to your child’s doctor about side effects.

You can report side effects to the National Health Office.

What is the best way to give this drug?

Give this drug to your child as directed by the doctor. Read all the information provided to you. Follow all instructions strictly.

All forms of issue:

• Give this drug with or without food.

Liquid (solution):

• Doses of liquid preparation should be measured with caution. Use the dispenser that comes with the medicine. If a dispenser is not included in the package, ask your pharmacist for the dosage for this drug.
• This medication should not be measured with a regular teaspoon or tablespoon. This can lead to exceeding the dose of the drug.

What if my child misses a dose of a drug?

All forms of issue:

• Give the missed dose as soon as possible.
• If it is time for your child to take the next dose, do not take the missed dose and then return to your child’s normal schedule.
• Do not give a double dose at the same time or additional doses.

Tablets:

• This drug should be taken as needed to treat a gout attack.

How do I store and / or discard this drug?

Tablets and capsules:

• Store at room temperature, protected from light.Store in a dry place. Do not store in the bathroom.

Liquid (solution):

• Store at room temperature in a dry place. Do not store in the bathroom.

All forms of issue:

• The lid must be tightly closed.
• Store all medicines in a safe place. Keep all medicines out of the reach of children and pets.
• Dispose of unused or expired drugs.Do not empty into toilet or drain unless directed to do so. If you have any questions about the disposal of your medicinal products, consult your pharmacist. Your area may have drug recycling programs.

General information on medicinal products

• If your child’s symptoms or health problems do not improve, or if they get worse, see your child’s doctor.
• Do not share your child’s medication with others or give anyone else’s medication to your child.
• Some medicines may have different patient information sheets. If you have questions about this drug, talk with your doctor, nurse, pharmacist, or other healthcare professional.
• A separate patient instruction sheet is attached to the product. Please read this information carefully. Reread it every time you replenish your supply. If you have questions about this drug, talk with your doctor, pharmacist, or other healthcare professional.
• If you think there has been an overdose of a drug, call a Poison Control Center immediately or seek medical attention. Be prepared to tell or show which drug you took, how much and when it happened.

Use of information by consumer and limitation of liability

This information should not be used to make decisions about taking this or any other drug. Only the attending physician has the necessary knowledge and experience to make decisions about which drugs are appropriate for a particular patient.This information does not guarantee that the drug is safe, effective, or approved for the treatment of any disease or specific patient. Here are only brief general information about this drug. It does NOT contain all available information on the possible use of the drug with instructions for use, warnings, precautions, information about interactions, side effects and risks that may be associated with this drug. This information should not be construed as a guide to treatment and does not replace the information provided to you by your healthcare professional.For complete information on the possible risks and benefits of taking this drug, consult your doctor. Use of this information is governed by the Lexicomp End User License Agreement available at https://www.wolterskluwer.com/en/solutions/lexicomp/about/eula.

Copyright

© UpToDate, Inc. and its affiliates and / or licensors, 2021. All rights reserved.

90,000 💊 Colcrys, mitigare (colchicine) side effects, interactions, uses and imprint of the medication

Brand Names: Colcrys, Mitigare

Generic name: colchicine

What is colchicine (Colcrys, Mitigare)?

Colchicine affects the body’s response to uric acid crystals, which reduces swelling and pain.

Because colchicine was developed prior to federal regulations requiring FDA review of all marketed drugs, not all uses of colchicine have been approved by the FDA.

Colchicine Brand Colcrys is FDA approved for the treatment or prevention of gout in adults and for the treatment of a genetic condition called Familial Mediterranean Fever in adults and children at least 4 years of age.

Colchicine Grade Mitigare is FDA approved for the prevention of gout flare-ups in adults.

Common forms of colchicine have been used to treat or prevent gout attacks or to treat symptoms of Behcet’s syndrome (such as swelling, redness, warmth, and pain).

Colchicine is not a cure for gouty arthritis or Behcet’s syndrome, and it will not prevent these diseases. Colchicine should not be used as a conventional pain reliever for other conditions.

Colchicine

may also be used for purposes not listed in this medication guide.

capsule, blue / light blue, imprinted by West Ward, 118

purple capsule labeled AR 374

purple capsule labeled AR 374

capsule, blue / light blue, imprinted by West Ward, 118

round, white, imprinted with EP 104

round, white, embossed 944, DAN

round, white, sealed with west ward 201

What are the possible side effects of colchicine (Colcrys, Mitigare)?

Seek emergency medical attention if you have signs of an allergic reaction : urticaria; labored breathing; swelling of the face, lips, tongue, or throat.

Call your doctor right away if you have:

• Muscle pain or weakness;
• Numbness or tingling in fingers or toes;
• Pale or gray appearance of lips, tongue, or hands;
• severe or ongoing vomiting or diarrhea;
• fever, chills, body aches, flu symptoms; or
• slight bruising, unusual bleeding, feeling weak or tired.

Common side effects may include:

• nausea, vomiting, abdominal pain; or
• diarrhea.

This is not a complete list of side effects and others may arise. Ask your doctor about side effects. You can report side effects to the FDA at 1-800-FDA-1088.

What is the most important information I should know about colchicine (Colcrys, Mitigare)?

Serious drug interactions can occur when certain medicines are used together with colchicine. Tell each of your healthcare providers about all medicines you are using now and any medicines you start or stop using.

What should I discuss with my healthcare provider before taking colchicine (Colcrys, Mitigare)?

You should not use colchicine if you are allergic to it.

Some medicines can cause unwanted or dangerous effects when used with colchicine, especially if you have liver or kidney disease. Your doctor may need to change your treatment plan if you are using any of the following drugs:

• cyclosporine;
• nefazodone;
• tipranavir;
• clarithromycin or telithromycin;
• itraconazole or ketoconazole; or
• Drugs for the treatment of HIV or AIDS – atazanavir, darunavir, fosamprenavir, indinavir, lopinavir, nelfinavir, ritonavir or saquinavir.

To make sure colchicine is safe for you, tell your doctor if you have:

• liver disease;
• Kidney disease; or
• If you are taking digoxin or drugs to lower your cholesterol.

It is not known if this medicine will harm an unborn baby. Tell your doctor if you are pregnant or planning to become pregnant.

Colchicine can pass into breast milk and may harm a nursing baby.Tell your doctor if you are breastfeeding.

How to take colchicine (Colcrys, Mitigare)?

Do not buy colchicine online or from suppliers outside the United States. Using this medication incorrectly or without consulting your doctor can lead to serious side effects or death.

Follow all directions on the prescription label. Do not take this medication in larger or smaller amounts, or for longer than recommended.

Colchicine can be taken with or without food.

For gout attacks, for best results, take colchicine at the first sign of a gout attack. The longer you wait to start taking the medicine, the less effective it may be.

You may need to take a second lower dose of colchicine 1 hour after the first dose if you still have gout. Follow your doctor’s instructions.

Your dose will depend on the reason you are taking this medicine. Doses of colchicine are different for gout and Mediterranean fever.

Do not stop using colchicine unless your doctor tells you to , even if you feel well.

Call your doctor if your symptoms do not improve or if they get worse.

If you have been using this medicine for a long time, you may need frequent medical tests.

Store at room temperature away from moisture, heat and light. Keep bottle tightly closed when not in use.

What happens if I miss a dose (Colcrys, Mitigare)?

Take the missed dose as soon as you remember.Skip the missed dose if it’s almost time for your next scheduled dose. Do not take an additional medication to make up for a missed dose.

What happens if I overdose (Colcrys, Mitigare)?

Seek emergency medical attention or call the Poison Helpline at 1-800-222-1222. An overdose of colchicine can be fatal.

Overdose symptoms may include diarrhea, nausea, vomiting, abdominal pain, muscle weakness, poor or no urination, numbness or tingling, weak pulse, rapid heartbeat, weak or shallow breathing, or fainting.

What should I avoid while taking colchicine (Colcrys, Mitigare)?

Grapefruit and grapefruit juice can interact with colchicine and cause unwanted side effects. Avoid using grapefruit products while taking colchicine.

What other drugs will affect colchicine (Colcrys, Mitigare)?

Many medicines can interact with colchicine and some medicines should not be used together. This includes prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed in this Medication Guide. Tell your doctor about all medicines you use and those you start or stop using during colchicine treatment. Give a list of all your medicines to any doctor who treats you.

Your pharmacist can provide more information about colchicine.

Interaction of grapefruit with drugs | Medicinal chronograph

Summary. This mini-review discusses the main scientific concepts and clinical manifestations of drug interactions between grapefruit. Grapefruit, and to a lesser extent bitter oranges, pomelo, and lime, can interact with some oral medications. The main active ingredient appears to be furanocoumarins. Sweet oranges do not contain furanocoumarins. The interaction is based on the inactivation of the CYP 3A4 enzyme, which is involved in the metabolism of many drugs.Some clinically significant side effects are discussed. The interaction of grapefruit with drugs is generally considered an undesirable phenomenon, however, the ability of grapefruit to increase bioavailability can find practical application in order to reduce the doses of drugs. The pharmacological action of grapefruit is subject to significant fluctuations, which is associated with dosing difficulties in a narrow therapeutic window. In this regard, it seems promising to develop medicinal preparations based on grapefruit components that could be more accurately dosed.Thus, grapefruit, like other citrus fruits, is a valuable food product. However, its interactions with certain medications can lead to overdose symptoms. Understanding these mechanisms is important in determining the indications and contraindications for the use of grapefruit in combination with various drugs.

UDC 634.32 + 615.015.2

Recently, the effect of grapefruit on the effectiveness of certain drugs has been repeatedly reported (Kanazawa S.et al., 2001; Mahgoub A.A. 2002; Okura T. et al., 2008; Seidegård J. et al., 2009; Nieminen T.H. et al., 2010; Bailey D.G. et al., 2013). Other citrus fruits have a similar property to some extent: bitter oranges (Sevilla), pomelo and lime (Malhotra S. et al., 2001; Guo L.Q. et al., 2007). No drug interactions were observed in sweet oranges (Neville, Valencia) (Bailey D.G. et al., 2013). The influence of grapefruit variety (white, pink) and storage conditions has not been studied enough.

The main mechanism of interaction of grapefruit with drugs is the inactivation of enzymes of the cytochrome P450 family, especially CYP 3A4, which is involved in the metabolism of many drugs. The enzyme is localized in the epithelium of the small and large intestines, as well as in the liver. Inactivation of CYP 3A4 by grapefruit juice occurs predominantly in the small intestine; however, ingestion of large amounts of grapefruit may decrease liver CYP 3A4 activity. Inactivation of the enzyme increases the bioavailability of certain drugs and their concentration in the blood, which can lead to symptoms of overdose.Inactivating agents in grapefruit are furanocoumarins, as well as the flavonoid naringin and its metabolite naringenin, bergamottin and other components (Kanazawa S. et al., 2001; Bailey D.G. et al., 2013). The effect of grapefruit on pharmacokinetics is expressed in an increase in the maximum concentration of the drug in blood plasma and the area under the concentration-time curve. The pharmacokinetics of drugs administered intravenously does not change significantly under the influence of grapefruit (Ducharme M.P. et al., 1995; Lundahl J. et al., 1995).

The list of drugs, the use of which in combination with grapefruit can lead to side effects, is presented in the review by D.G. Bailey et al (2013). These include some calcium channel blockers, β-adrenergic receptor blockers, analgesics, corticosteroids, estrogens, benzodiazepines, statins, antibiotics, antiviral (including those used for HIV infection), antineoplastic, antiallergic, psychotropic and other drugs (Kanazawa S.et al., 2001; Mahgoub A.A. 2002; Okura T. et al., 2008; Seidegård J. et al., 2009; Nieminen T.H. et al., 2010). It is important to emphasize that the interaction with grapefruit does not characterize groups, but individual drugs. Common signs of such drugs include low or moderate bioavailability (up to 70%), inactivation by the CYP 3A4 enzyme, and per os . The clinical significance of the interactions of grapefruit with medicinal substances depends on the breadth of the therapeutic effect, the severity of overdose symptoms, the nature of the grapefruit consumption, the age and individual characteristics of the patient (Bailey D.G. et al., 2013).

In some studies, participants received more grapefruit than they normally consume. However, when consumed in usual doses (200–250 ml of juice or one whole fruit), grapefruit can have a clinically significant effect on the action of some drugs. It was reported, for example, that taking the calcium channel blocker felodipine in combination with grapefruit at the indicated dose led to a 3-fold increase in the systemic concentration of the drug compared to the control. When drinking grapefruit juice, 250 ml 3 times a day for 6 days, taking felodipine at the usual dosage was accompanied by an approximately 5-fold increase in systemic concentration.The interval between grapefruit and medication is also important. The maximum effect was achieved with the use of grapefruit less than 4 hours before taking felodipine or nisoldipine; with an increase in the interval to 24 hours, a decrease in the severity of the effect to 25% after a single dose and 50% after repeated use of grapefruit was noted (Lundahl J. et al., 1995; Takanaga H. et al., 2000; Bailey DG et al., 2013) … High individual variability of interaction was noted (Dresser G.K. et al., 2000).The effect of grapefruit depends on the individual characteristics of the organism, in particular the age of the patient and the activity of the CYP 3A4 enzyme. Activity can be determined on a biopsy of the small intestine, which, however, is unjustified due to the invasive nature of the procedure.

There are reports of side effects of the simultaneous use of grapefruit and various drugs due to excessive systemic concentration of the drug (Goldbart A. et al., 2000; Hermans K. et al., 2003; Dreier J.P., Endres M., 2004; Karch A.M. 2004; Grande L.A. et al., 2009; Pillai U. et al., 2009; Agosti S. et al., 2012). This topic is especially relevant for older patients who take on average more drugs and often consume grapefruit (Dresser G.K. et al., 2000; Bailey D.G. et al., 2013). Older people have less compensatory ability to neutralize drug overdose. For drugs with a significant range of therapeutic action, fluctuations in the concentration of a drug in blood plasma over a wide range may not have clinically significant consequences.On the other hand, even a moderate increase in the concentration of a drug with dose-dependent toxicity can lead to side effects. An example is the lengthening of the interval Q – T on the electrocardiogram, observed when taking certain anticancer and antiarrhythmic drugs in combination with grapefruit; in this case, the development of ventricular tachycardia (torsades de pointes) is possible. Such cardiac symptoms are regarded as a contraindication to the use of grapefruit in combination with appropriate drugs, even with a moderate increase in bioavailability under its influence.This approach is also justified in the case of a real risk of other complications: rhabdomyolysis, nephro- and myelotoxic effects, etc. (Mazokopakis E.E., 2008; Bailey D.G. et al., 2013). The instructions for the respective medicinal products should contain information on interactions with grapefruit. If, despite contraindications, the patient wishes to regularly consume grapefruit, you can try to reduce the dose of the drug or replace it with another drug that does not interact with grapefruit.

The interaction of grapefruit with drugs in general is considered as an undesirable phenomenon, however, the property of grapefruit to increase bioavailability may find practical application.Increasing bioavailability means achieving a therapeutic effect with a lower dose of a drug with a lower systemic concentration of its metabolites. Patients who regularly consume grapefruit can be tried at a lower dose. Given the variability in the pharmacological action of grapefruit, the approach must be careful. Below are some examples.

There is evidence that the use of grapefruit increases the bioavailability of cyclosporine, an expensive drug used for many years to prevent allograft rejection (Ducharme M.P. et al. 1995; Hollander A.A. et al. 1995; Sridharan K., Sivaramakrishnan G., 2016). Artemether is an effective agent against malaria, however, with monotherapy, relapses of malaria are possible, presumably due to a decrease in the concentration of the drug in the blood plasma under the influence of CYP 3A4. The consumption of grapefruit increases the bioavailability of artemether, which may be accompanied by an increase in the effectiveness of therapy (El-Lakkany N.M. et al., 2004). Of particular note is the increase in the bioavailability of some analgesics (morphine, oxycodone and diclofenac) under the influence of grapefruit (Mahgoub A.A., 2002; Okura T. et al., 2008; Nieminen T.H. et al., 2010). For paracetamol, the data are contradictory (Dasgupta A. et al., 2008; Qinna N.A. et al., 2016). It is obvious that the topic of potentiating the action of analgesics requires further study. An increase in the bioavailability of glucocorticoids (methylprednisolone, budesonide) under the influence of grapefruit has also been reported (Varis T. et al., 2000; Seidegård J. et al., 2009), which opens up the prospect of research on grapefruit as a means of reducing doses of hormonal drugs.For prednisolone, a negative result was obtained (Hollander A.A. et al., 1995). Interactions of grapefruit with antibiotics are also of interest: an increase in the bioavailability of erythromycin under the action of grapefruit juice has been reported; for clarithromycin, the result is negative (Hollander A.A. et al., 1995; Kanazawa S. et al., 2001). It has been reported that grapefruit and the naringin it contains have beneficial effects on diabetes and obesity (Jung U.J. et al., 2004; Punithavathi V.R. et al., 2008; Mahmoud A.M. et al., 2012; Xulu S., Oroma Owira P. M., 2012; Alam M.A. et al., 2014; Chudnovskiy R. et al., 2014; Murunga A.N. et al., 2016; Sirovina D. et al., 2016). Further clinical and experimental studies of the interactions of grapefruit with antihyperglycemic drugs and insulin are needed.

The effect of grapefruit varies from patient to patient and from study to study. Efficiency may vary depending on the variety, batch, storage conditions, and the characteristics of juice production, which complicates dosage in a narrow therapeutic window.In this regard, it seems promising to develop medicinal preparations based on grapefruit components that could be accurately dosed. Some dietary supplements from grapefruit seeds and peel are positioned as an antibacterial agent, however, data on the antibacterial properties of grapefruit are contradictory (von Woedtke T. et al., 1999; Heggers JP et al., 2002; Cvetnić Z., Vladimir-Knezević S., 2004; Adukwu EC et al., 2012).

In a medicinal product based on grapefruit, the content of furanocoumarins, naringin and other active components must be known.Naringin accumulates in young fruits; with further ripening of the grapefruit, its concentration may decrease. Inside the fruit, the maximum concentration is found in the membranes, the white layer of the rind (albedo) and the core; in pure juice the concentration is lower (Jourdan P.S. et al., 1985). Accordingly, to achieve a pharmacological effect, it is better to use whole grapefruit or natural juice with pulp; moreover, the concentration of naringin (which has a bitter taste) and other components in the juices sold can be reduced.

In conclusion, we note that grapefruit and some other citrus fruits are valuable food products. At the same time, the interaction of grapefruit with some medicinal substances leads to an increase in their bioavailability. The latter can cause symptoms of overdose, which is especially unfavorable in the case of dose-dependent toxicity. Understanding the mechanisms of such interaction is important for determining the indications and contraindications for the use of grapefruit in combination with various drugs in order to ensure the safety and effectiveness of therapy.

List of used literature

• Adukwu E.C., Allen S.C., Phillips C.A. (2012) The anti-biofilm activity of lemongrass (Cymbopogon flexuosus) and grapefruit (Citrus paradisi) essential oils against five strains of Staphylococcus aureus . J. Appl. Microbiol. 113 (5): 1217-1227.
• Agosti S., Casalino L., Bertero G. et al. (2012) A dangerous fruit juice. Am. J. Emerg. Med., 30 (1): 248.e5-248.e8.
• Alam M.A., Subhan N., Rahman M.M. et al. (2014) Effect of citrus flavonoids, naringin and naringenin, on metabolic syndrome and their mechanisms of action. Adv. Nutr., 5 (4): 404-417.
• Bailey D.G., Dresser G., Arnold J.M. (2013) Grapefruit-medication interactions: forbidden fruit or avoidable consequences? CMAJ, 185 (4): 309-316.
• Chudnovskiy R., Thompson A., Tharp K. et al. (2014) Consumption of clarified grapefruit juice ameliorates high-fat diet induced insulin resistance and weight gain in mice.PLoS One, 9 (10): e108408.
• Cvetnić Z., Vladimir-Knezević S. (2004) Antimicrobial activity of grapefruit seed and pulp ethanolic extract. Acta Pharm., 54 (3): 243-250.
• Dasgupta A., Reyes M.A., Risin S.A., Actor J.K. (2008) Interaction of white and pink grapefruit juice with acetaminophen (paracetamol) in vivo in mice. J. Med. Food, 11 (4): 795-798.
• Dreier J.P., Endres M. (2004) Statin-associated rhabdomyolysis triggered by grapefruit consumption.Neurology, 62 (4): 670.
• Dresser G.K., Bailey D.G., Carruthers S.G. (2000) Grapefruit juice – felodipine interaction in the elderly. Clin. Pharmacol. Ther., 68 (1): 28–34.
• Ducharme M.P., Warbasse L.H., Edwards D.J. (1995) Disposition of intravenous and oral cyclosporine after administration with grapefruit juice. Clin. Pharmacol. Ther., 57 (5): 485-491.
• El-Lakkany N.M., Seif el-Din S.H., Badawy A.A., Ebeid F.A. (2004) Effect of artemether alone and in combination with grapefruit juice on hepatic drug-metabolizing enzymes and biochemical aspects in experimental Schistosoma mansoni .Int. J. Parasitol. 34 (12): 1405-1412.
• Goldbart A., Press J., Sofer S., Kapelushnik J. (2000) Near fatal acute colchicine intoxication in a child. A case report. Eur. J. Pediatr. 159 (12): 895-897.
• Grande L.A., Mendez R.D., Krug R.T., Verschuyl E.J. (2009) Attention – grapefruit! Lancet, 373 (9670): 1222.
• Guo L.Q., Chen Q.Y., Wang X. et al. (2007) Different roles of pummelo furanocoumarin and cytochrome P450 3A5 * 3 polymorphism in the fate and action of felodipine.Curr. Drug Metab., 8 (6): 623-630.
• Heggers J. P., Cottingham J., Gusman J. et al. (2002) The effectiveness of processed grapefruit-seed extract as an antibacterial agent: II. Mechanism of action and in vitro toxicity. J. Altern. Complement. Med., 8 (3): 333-340.
• Hermans K., Stockman D., van den Branden F. (2003) Grapefruit and tonic: a deadly combination in a patient with the long QT syndrome. Am. J. Med. 114 (6): 511-512.
• Hollander A.A., van Rooij J., Lentjes G. W. et al. (1995) The effect of grapefruit juice on cyclosporine and prednisone metabolism in transplant patients. Clin. Pharmacol. Ther., 57 (3): 318-324.
• Jourdan P.S., McIntosh C.A., Mansell R.L. (1985) Naringin Levels in Citrus Tissues: II. Quantitative Distribution of Naringin in Citrus paradisi MacFad. Plant Physiol., 77 (4): 903-908.
• Jung U.J., Lee M.K., Jeong K.S., Choi M.S. (2004) The hypoglycemic effects of hesperidin and naringin are partly mediated by hepatic glucose-regulating enzymes in C57BL / KsJ-db / db mice.J. Nutr. 134 (10): 2499-2503.
• Kanazawa S., Ohkubo T., Sugawara K. (2001) The effects of grapefruit juice on the pharmacokinetics of erythromycin. Eur. J. Clin. Pharmacol., 56 (11): 799-803.
• Karch A.M. (2004) The grapefruit challenge: the juice inhibits a crucial enzyme, with possibly fatal consequences. Am. J. Nurs., 104 (12): 33-35.
• Lundahl J., Regårdh C.G., Edgar B., Johnsson G. (1995) Relationship between time of intake of grapefruit juice and its effect on pharmacokinetics and pharmacodynamics of felodipine in healthy subjects.Eur. J. Clin. Pharmacol. 49 (1-2): 61-67.
• Mahgoub A.A. (2002) Grapefruit juice potentiates the anti-inflammatory effects of diclofenac on the carrageenan-induced rat’s paw oedema. Pharmacol. Res., 45 (1): 1-4.
• Mahmoud A.M., Ashour M.B., Abdel-Moneim A., Ahmed O.M. (2012) Hesperidin and naringin attenuate hyperglycemia-mediated oxidative stress and proinflammatory cytokine production in high fat fed / streptozotocin-induced type 2 diabetic rats.J. Diabetes Complications, 26 (6): 483-490.
• Malhotra S., Bailey D.G., Paine M.F., Watkins P.B. (2001) Seville orange juice-felodipine interaction: comparison with dilute grapefruit juice and involvement of furocoumarins. Clin. Pharmacol. Ther., 69 (1): 14–23.
• Mazokopakis E.E. (2008) Unusual causes of rhabdomyolysis. Intern. Med. J., 38 (5): 364-367.
• Murunga A.N., Miruka D.O., Driver C. et al. (2016) Grapefruit derived flavonoid naringin improves ketoacidosis and lipid peroxidation in type 1 diabetes rat model.PLoS One, 11 (4): e0153241.
• Nieminen T.H., Hagelberg N.M., Saari T.I. et al. (2010) Grapefruit juice enhances the exposure to oral oxycodone. Basic Clin. Pharmacol. Toxicol. 107 (4): 782-788.
• Okura T., Ozawa T., Ito Y. et al. (2008) Enhancement by grapefruit juice of morphine antinociception. Biol. Pharm. Bull., 31 (12): 2338-2341.
• Pillai U., Muzaffar J., Sen S., Yancey A. (2009) Grapefruit juice and verapamil: a toxic cocktail.South Med. J., 102 (3): 308-309.
• Punithavathi V.R., Anuthama R., Prince P.S. (2008) Combined treatment with naringin and vitamin C ameliorates streptozotocin-induced diabetes in male Wistar rats. J. Appl. Toxicol. 28 (6): 806-813.
• Qinna N.A., Ismail O.A., Alhussainy T.M. et al. (2016) Evidence of reduced oral bioavailability of paracetamol in rats following multiple ingestion of grapefruit juice. Eur. J. Drug Metab. Pharmacokinet., 41 (2): 187-195.
• Seidegård J., Randvall G., Nyberg L., Borgå O. (2009) Grapefruit juice interaction with oral budesonide: equal effect on immediate-release and delayed-release formulations. Pharmazie, 64 (7): 461-465.
• Sridharan K., Sivaramakrishnan G. (2016) Interaction of citrus juices with cyclosporine: systematic review and meta-analysis. Eur. J. Drug Metab. Pharmacokinet., 41 (6): 665-673.
• Sirovina D., Oršolić N., Gregorović G., Končić M.Z. (2016) Naringenin ameliorates pathological changes in liver and kidney of diabetic mice: a preliminary study. Arh. Hig. Rada Toksikol., 67 (1): 19-24.
• Takanaga H., Ohnishi A., Murakami H. et al. (2000) Relationship between time after intake of grapefruit juice and the effect on pharmacokinetics and pharmacodynamics of nisoldipine in healthy subjects. Clin. Pharmacol. Ther., 67 (3): 201-214.
• Varis T., Kivistö K.T., Neuvonen P.J. (2000) Grapefruit juice can increase the plasma concentrations of oral methylprednisolone.Eur. J. Clin. Pharmacol. 56 (6-7): 489-493.
• von Woedtke T., Schlüter B., Pflegel P. et al. (1999) Aspects of the antimicrobial efficacy of grapefruit seed extract and its relation to preservative substances contained. Pharmazie, 54 (6): 452-456.
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D.J. Bailey, S.V. Yargin

Summary. The ministry will discuss the basic science concepts and the clinical manifestation of the interaction of grapefruit with drugs. Grapefruit and in a small world – girky oranges, pomelo and lime can be combined with the actions taken in the middle of the middle of the day. The main active ingredient, Mabut, є furanocoumarini. Oranges of licorice varieties of furanocoumarins cannot be revenged. The basis of the relationship is the activation of the CYP 3A4 enzyme, which will take care of the fate of the metabolism of the bagatokh likiv.Negotiate actions of key important secondary effects. The interaction of grapefruit with the faces is generally seen as a non-essential phenomenon, the protest power of grapefruit is more easily accessible. The pharmacological nature of grapefruit is influenced by significant numbers, which is tied because of the difficult dosages in the minds of a high school therapeutic ward. The link with cym is an extremely promising distribution based on grapefruit components of drug preparations, which can be done more accurately.Identical grapefruit, yak and іnshі citrus fruits, є a valuable food product. Vodnochas yogo vzaєmodії with deyakim lykarsky drugs can lead to symptoms of overdose. The cleverness of the cich mechanizm is important for the purpose of showing and proving before the grapefruit is grown in the common with small licars.

Key words: grapefruit, pharmacotherapy, pharmacokinetics, interaction, development.

Address for correspondence:
Yargin Sergey Vadimovich
115184, Moscow, per.Klimentovsky, 6, apt. 82
E-mail: [email protected]

Received 02/05/2017

Colchicine Oral: uses, side effects, interactions, pictures, warnings and dosing –

Benefits

Benefits

This medicine is used to prevent or treat gout attacks (flare-ups). Gout symptoms usually develop suddenly and affect only one or a few joints. The joints of the thumb, knee, or ankle are most commonly affected.Gout is caused by too much uric acid in the blood. When uric acid levels in the blood are too high, uric acid can form hard crystals in the joints. Colchicine works by reducing swelling and reducing the formation of uric acid crystals that cause pain in the affected joint (s).

This drug is also used to prevent bouts of pain in the abdomen, chest, or joints caused by a certain inherited condition (familial Mediterranean fever).It is thought to work by decreasing the body’s production of a certain protein (amyloid A) that accumulates in people with familial Mediterranean fever.

Colchicine is not a pain reliever and should not be used to relieve other causes of pain.

How to use colchicine

Read the medication guide provided by your pharmacist before starting colchicine and each time you take this medicine again. If you have any questions about the information, ask your doctor or pharmacist.

Take this medication by mouth with or without food, as directed by your healthcare practitioner. Dosing recommendations vary greatly and may differ from the following recommendations. Taking a dose higher than the recommended dose may not improve the effectiveness of this drug and increase the risk of side effects. Ask your doctor or pharmacist for more details.

If you are taking this medication to treat a gout attack, carefully follow the directions given by your doctor.This medication works best if you take it at the first sign of a seizure. The recommended dose is 1.2 milligrams at the first sign of an attack, then 0.6 milligrams one hour later. The maximum recommended dose is 1.8 mg in 1 hour. Ask your doctor ahead of time about how soon you can repeat treatment with this medicine if you have another gout attack.

If you are taking this medicine to prevent gout or pericarditis attacks, ask your doctor about the dose and schedule you should follow.Follow your doctor’s instructions carefully.

If you are taking this medicine to prevent bouts of pain caused by familial Mediterranean fever, the usual dose is 1.2 to 2.4 mg per day. The total dose can be taken once a day or divided into two doses per day. Your doctor may need to adjust your dose to control your symptoms or if you have side effects.

Dosage depends on your medical condition, other drugs / products you are taking, and response to treatment.To reduce the risk of serious side effects, do not increase your dose, take it more often, or take it longer than your doctor tells you to. Serious side effects can occur even at the usual prescribed doses.

If your doctor prescribes you to take colchicine regularly, use it regularly to get the most out of it. To help you remember, take it at the same time every day.

Avoid drinking grapefruit or drinking grapefruit juice during treatment with this medicine, unless instructed to do so by your doctor.Grapefruit can increase the amount of certain drugs in your blood. Check with your doctor or pharmacist for more details.

If you are taking this medicine to treat symptoms of familial Mediterranean fever, tell your doctor if your condition does not improve or if it gets worse.

Related links

What conditions does colchicine treat?

Side effects

Side effects

Diarrhea, nausea, cramps, abdominal pain and vomiting may occur.If any of these effects persist or worsen, tell your doctor or pharmacist right away.

Remember that your doctor prescribed this medication for you because he or she thought the benefit to you was greater than the risk of side effects. Many people using this medication do not have serious side effects.

Stop taking this medication and get medical help right away if any of these very serious side effects occur: unusual bleeding / bruising, severe diarrhea or vomiting, muscle weakness or pain, numbness / tingling in the fingers or toes, pale or gray lips / tongue / palms of hands, signs of infection (such as fever, persistent sore throat), unusual weakness / fatigue, rapid heart rate, shortness of breath, signs of kidney problems (such as changes in the amount of urine).

A very serious allergic reaction to this drug is rare. However, see your doctor immediately if you notice any symptoms of a serious allergic reaction, including: rash, itching / swelling (especially of the face / tongue / throat), severe dizziness, trouble breathing.

This is not a complete listing of potential side effects. If you notice other effects not listed above, ask your doctor or pharmacist.

In the USA –

Ask your doctor about side effects. You can report side effects to the FDA by calling 1-800-FDA-1088 or at www.fda.gov/medwatch.

In Canada – Call your doctor for medical advice about side effects. You can report side effects to Health Canada at 1-866-234-2345.

Related links

List the side effects of colchicine by likelihood and severity.

Precautions

Precautions

Before taking this medicine, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies.This product may contain inactive ingredients that may cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially: kidney problems, liver problems (eg cirrhosis of the liver).

Alcohol may reduce the effectiveness of this drug. Limit your alcohol intake while taking this drug.

This medicine may affect how well your body absorbs certain foods and nutrients (such as vitamin B12). Check with your doctor or pharmacist for more details.

Before surgery, tell your doctor or dentist about all products you use (including prescription, non-prescription, and herbal products).

The elderly may be more sensitive to the side effects of this drug, especially muscle weakness / pain and numbness / tingling in the fingers and toes.

Colchicine can reduce sperm production, which can affect a man’s ability to raise a child. Consult your doctor for more information.

During pregnancy, this medication should be used only when necessary. Discuss the risks and benefits with your doctor.

This medicine passes into breast milk. Although there have been no reports of harm to nursing babies, consult a doctor before breastfeeding.Your doctor may recommend that you separate your medication time from breastfeeding.

Related links

What should I know about pregnancy, caring for and prescribing colchicine to children or the elderly?

interactions

interactions

See also How to Use and Precautions sections.

The effect of some medicines may change if you take other medicines or herbal products at the same time.Doing so may increase your risk of serious side effects or may cause your medications to not work properly. These drug interactions are possible, but not always the case. Your doctor or pharmacist can often prevent or control interactions by changing the way you use the drugs or by carefully monitoring them.

To help your doctor and pharmacist provide you with the best possible care, be sure to tell your doctor and pharmacist about all products you use (including prescription, over-the-counter, and herbal products) before starting treatment with this product.When using this product, do not start, stop, or change the dosage of any other medicines you are using without your doctor’s permission.

Other medicines can affect the removal of colchicine from your body, which may interfere with how colchicine works or increase the risk of serious side effects. Examples include certain azole antifungals (such as itraconazole, ketoconazole), diltiazem, HIV medications (such as ritonavir), macrolide antibiotics (such as clarithromycin, erythromycin), telithromycin, verapamil, and others.

Colchicine rarely causes some serious (even fatal) muscle damage (rhabdomyolysis). This muscle damage releases substances that can lead to serious kidney problems. The risk may be increased if other medicines that can also cause rhabdomyolysis are taken with colchicine. Some of the drugs affected include: atorvastatin, digoxin, gemfibrozil, pravastatin, simvastatin, and others.

This medicine may interfere with certain laboratory tests, possibly causing false test results.Make sure laboratory staff and all of your doctors know you are using this drug.

This document does not contain all possible drug interactions. Keep a list of all the products you use. Share this list with your doctor and pharmacist to reduce your risk of serious medication problems.

Related links

Does colchicine interact with other medications?

Should I avoid certain foods while taking colchicine?

overdose

overdose

If someone has overdose and has severe symptoms such as fainting or trouble breathing, call 911.If not, contact a Poison Control Center immediately. US residents can call their local poison control center at 1-800-222-1222. Residents of Canada can call the provincial poison control center. Overdose symptoms may include: severe nausea / vomiting / diarrhea, abdominal pain, trouble breathing, weakness.

Notes

Do not share this medicine with others.

Being overweight, drinking too much alcohol, and consuming certain foods can worsen the symptoms of gout.Limit alcohol consumption and ask your doctor, pharmacist, or dietitian to avoid foods high in purines that can worsen gout (such as anchovies, bacon, beer, sardines, organ meats including liver / kidney).

Laboratory and / or medical tests (such as blood tests, kidney function, liver function) may be done periodically to monitor your progress or to check for side effects. See your doctor for more details.

Missed dose

If you regularly take colchicine and miss a dose, take it as soon as you remember. If it is close to your next dose, skip the missed dose and resume your normal dosing regimen. Don’t double your dose to catch up.

Storage

Store at room temperature away from light and moisture. Do not store in the bathroom. Keep all medicines out of the reach of children and pets.

Do not flush medicines down the toilet or pour them down the drain unless directed to do so.Correctly discard this product when it has expired or is no longer needed. Check with your pharmacist or local waste disposal company. The information was updated in September 2017. Copyright (c) 2017 First Databank, Inc.

Images of colchicine 0.6 mg capsule

Colchicine 0.6 mg capsules

color

dark blue, light blue

form

oblong

imprint

West Ward, 118

Colchicine 0.6 mg tablets

Colchicine 0.6 mg tablets

color

purple

form

oblong

imprint

AR 374

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