Renal or hepatic impairment (including failure) and GI hemorrhage reported. Some cases were fatal.
Such adverse reactions more frequently observed in patients with advanced age, high-risk myelodysplastic syndrome (MDS), underlying renal or hepatic impairment, or low platelet counts (<50,000/mm³). (See Renal Effects, Hepatic Effects, and also GI Effects under Cautions.)
Close patient monitoring, including laboratory testing of renal and hepatic function, required. Measure Scr and/or Clcr prior to initiation of therapy and monthly thereafter. In patients with underlying renal impairment or risk factors for renal impairment, monitor Scr and/or Clcr weekly for the first month, then monthly thereafter.
Measure serum transaminase and bilirubin concentrations prior to initiation of therapy, every 2 weeks during the first month, and monthly thereafter.
Take this medicine by mouth. Do not chew or take tablets whole. Follow the directions on the prescription label. Take this medicine on an empty stomach, at least 30 minutes before food. Do not take with food. Before taking, mix the dose in water, orange juice, or apple juice as directed. If your dose is less than 1 gram, use 3.5 ounces or about 1/2 glass of liquid. If your dose is 1 gram or more, use 7 ounces or about 1 full glass of liquid. Stir the medicine into the liquid until the tablets dissolve. Drink your dose right away after mixing. If there is any medicine left in the glass after you drink the mixture, add a little bit more liquid, swirl it around, and drink. Take your doses at regular intervals. Do not take your medicine more often than directed.
Talk to your pediatrician regarding the use of this medicine in children. While this medicine may be prescribed for children as young as 2 years of age for selected conditions, precautions do apply.
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.
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 doctor for regular check ups. You will need important blood work, vision tests, and hearing tests done while you are taking this medicine.
You may get drowsy or dizzy. Do not drive, use machinery, or do anything that needs mental alertness until you know how this medicine affects you. Do not stand or sit up quickly, especially if you are an older patient. This reduces the risk of dizzy or fainting spells.
Avoid taking antacids containing aluminum at the same time as this medicine.
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:
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). Protect from moisture. 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.
Remember, keep this and all other medicines out of the reach of children,
never share your medicines with others, and use this medication only for the indication prescribed.
