Severe worsening of hepatitis (rarely including death) has occurred when adefovir dipivoxil has been discontinued. When you are instructed to stop taking this medication, your doctor will monitor you closely for signs of worsening hepatitis. Be sure to keep all doctor and laboratory appointments after you stop taking this drug.
Infrequently, severe (sometimes fatal) liver and blood acid-base balance problems (lactic acidosis) have occurred while using a similar type of medication (nucleoside analogs such as didanosine or stavudine). Notify your doctor right away if you develop unusual weakness or fatigue, dark urine, yellowing of the skin or eyes, abdominal or stomach pain, drowsiness, muscle aches or weakness, trouble breathing (e.g., rapid breathing or very shallow breathing), or fast or irregular heartbeat.
If you get or have HIV infection that is not being treated with medication, adefovir dipivoxil may cause your HIV infection to become untreatable with the usual HIV drugs (development of HIV resistance). Consult your doctor or pharmacist for more details.Who should not take Hepsera?
This medication is used to treat a chronic viral infection of the liver (hepatitis B) in people 12 years of age and older. It works by slowing the growth of the virus. It is not a cure for hepatitis B and does not prevent the passing of hepatitis B to others.
This medication is a nucleotide analog.
Take this medication by mouth, usually once daily; or take as directed by your doctor. May take with or without food.
This medicine comes with a patient information leaflet. Read it carefully. Ask your doctor, nurse, or pharmacist any questions that you may have about this medicine.
Take this medication exactly as prescribed. Do not increase or decrease your dose or stop taking this medication unless directed to do so by your doctor or pharmacist.
Treatment with adefovir alone is not appropriate for patients infected with both hepatitis B and HIV. An HIV test is recommended both before and during treatment to ensure you receive appropriate treatment. Consult your doctor or pharmacist for more information.
Worsening of your condition, decreased response to therapy, or the occurrence of resistant strains of the virus may occur during or after treatment. Promptly report any new symptoms that occur during or after treatment to your doctor.
See also Warning section.
Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.
Tell your doctor right away if you have any serious side effects, including: signs of kidney problems (such as change in the amount of urine).
A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), dizziness, trouble breathing.
This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.
In the US -
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch.
In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.
Before taking adefovir, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.
This medication should be used only when clearly needed during pregnancy. Discuss the risks and benefits with your doctor.
Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.
Some products that may interact with this drug include: aminoglycosides (such as gentamicin, amikacin), amphotericin B, non-steroidal anti-inflammatory drugs (such as ibuprofen), tacrolimus, vancomycin.
Do not take products that contain tenofovir with this medication.
If overdose is suspected, contact a poison control center or emergency room right away. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center.
Do not share this medication with others.
To avoid spreading hepatitis B to others, always use an effective barrier method (e.g., latex condoms/dental dams) during sexual activity. Consult your doctor or pharmacist for more details.
Laboratory and/or medical tests (e.g., kidney function and liver function tests) may be performed to monitor your progress or check for side effects. Consult your doctor for more details. Keep all laboratory and medical appointments during and for several months after treatment.
If using this medication for an extended period of time, obtain refills before your supply runs out.
If you miss a dose, use it as soon as you remember that day. If it is near the time of the next dose, skip the missed dose and resume your usual dosing schedule. Do not double the dose to catch up.
Store in the original container at room temperature away from light and moisture. Do not store in the bathroom. Keep all medications away from children and pets.
Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company.
Information last revised April 2016. Copyright(c) 2016 First Databank, Inc.
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