Patient information: uses, side effects, how to take - Lodoco
What is LODOCO?
LODOCO is a prescription medicine used to reduce the risk of heart attack, stroke, certain types of heart procedures, and cardiovascular death in adults with:
known buildup of plaque inside the arteries (atherosclerotic disease), or
with multiple risk factors for cardiovascular disease.
Do not take LODOCO if you:
take certain medicines called strong CYP3A4 inhibitors or P-glycoprotein inhibitors. Ask your healthcare provider if you are not sure. Taking certain medicines with LODOCO may cause your level of LODOCO to be too high in your body and cause life-threatening side effects or death.
have severe kidney or liver problems.
have blood problems.
are allergic to colchicine or any of the ingredients in LODOCO. See the end of this leaflet for a complete list of ingredients in LODOCO.
Before taking LODOCO, 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 LODOCO will harm your unborn baby.
are breastfeeding or plan to breastfeed. LODOCO can pass into your breast milk. Talk to your healthcare provider about the best way to feed your baby during treatment with LODOCO.
Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Especially tell your healthcare provider if you take:
certain medicines called moderate CYP3A4 inhibitors
cholesterol lowering medicines
cyclosporine
antibiotics
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 LODOCO.
Taking LODOCO with certain other medicines can affect each other and cause serious side effects or death.
Do not start a new medicine without talking to your healthcare provider. Your healthcare provider can tell you if it is safe to take LODOCO with other medicines.
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.
How should I take LODOCO?
Take LODOCO exactly as your healthcare provider tells you to take it.
Do not change your dose or stop taking LODOCO without talking to your healthcare provider first.
Take LODOCO by mouth 1 time each day.
If you miss a dose of LODOCO, take it as soon you remember and then take your next dose at your regular time. Do not take 2 doses of LODOCO at the same time to make up for a missed dose.
If you take too much LODOCO, go to the nearest hospital emergency room right away.
What should I avoid while taking LODOCO?
Avoid eating grapefruit or drinking grapefruit juice while taking LODOCO. Grapefruit and grapefruit juice may increase your chance of side effects while taking LODOCO.
What are the possible side effects of LODOCO?
LODOCO may cause serious side effects, including:
Blood problems. LODOCO can cause low red blood cell counts, low white blood cell counts, and low platelet counts, which can be life-threatening or may lead to death.
Muscle weakness (neuromuscular toxicity). LODOCO can cause muscle weakness and muscle problems. Stop taking LODOCO and get medical help right away if you get muscle pain or weakness, or tingling or numbness in your fingers or toes.
The most common side effects of LODOCO include:
diarrhea, vomiting, and stomach-area (abdominal) cramping. Tell your healthcare provider right away if you develop any of these symptoms, they are often the first sign of having too much LODOCO in your body.
muscle pain
LODOCO may cause temporary fertility problems in males. This may affect your ability to father a child. Talk to your healthcare provider if this is a concern for you.
Tell your healthcare provider if you have any side effect that is new, that bothers you or that does not go away. These are not all of the possible side effects of LODOCO.
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
You may also report side effects to AGEPHA Pharma FZ LLC at 1-800-963-0353.
How should I store LODOCO?
Store LODOCO at room temperature between 68°F to 77°F (20°C to 25°C).
Store LODOCO in the original package in order to protect from light.
Keep LODOCO and all medicines out of the reach of children.
General information about the safe and effective use of LODOCO.
Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. Do not use LODOCO for a condition for which it was not prescribed. Do not give LODOCO to other people, even if they have the same symptoms that you have. It may harm them. You can ask your pharmacist or healthcare provider for information about LODOCO that is written for health professionals.
What are the ingredients in LODOCO?
Active Ingredient: colchicine.
Inactive Ingredients: gelatin, lactose monohydrate, magnesium stearate, potato starch, and talc.
Distributed by: AGEPHA Pharma USA, LLC, 181 New Road, Suite 304, Parsippany, NJ 07054 For more information, go to www.LODOCO.com or call 1-800-963-0353.
This Patient Information has been approved by the U.S. Food and Drug Administration. Issued: 06/2023