"Nov. 2, 2012 -- Safety steps taken in the wake of the fungal meningitis outbreak have worsened drug shortages, raising questions about whether the U.S. must choose between the safety and the availability of crucial medicines.
Risk of Medication Errors and Hepatotoxicity
Take care when prescribing, preparing, and administering OFIRMEV Injection to avoid dosing errors which could result in accidental overdose and death. In particular, be careful to ensure that:
- the dose in milligrams (mg) and milliliters (mL) is not confused;
- the dosing is based on weight for patients under 50 kg;
- infusion pumps are properly programmed; and
- the total daily dose of acetaminophen from all sources does not exceed maximum daily limits.
OFIRMEV contains acetaminophen. Acetaminophen has been associated with cases of acute liver failure, at times resulting in liver transplant and death. Most of the cases of liver injury are associated with the use of acetaminophen at doses that exceed the maximum daily limits, and often involve more than one acetaminophen-containing product (see WARNINGS).
OFIRMEV injection is a sterile, clear, colorless, non pyrogenic, isotonic formulation of acetaminophen intended for intravenous infusion. It has a pH of approximately 5.5 and an osmolality of approximately 290 mOsm/kg. Each 100 mL contains 1000 mg acetaminophen, USP, 3850 mg mannitol, USP, 25 mg cysteine hydrochloride, monohydrate, USP, 10.4 mg dibasic sodium phosphate, USP. pH is adjusted with hydrochloric acid and/or sodium hydroxide.
What are the possible side effects of acetaminophen injection (Ofirmev)?
Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.
Stop taking this medication and call your doctor at once if you have a serious side effect such as:
- nausea, upper stomach pain, itching, loss of appetite;
- dark urine, clay-colored stools;
- jaundice (yellowing of the skin or eyes); or
- chest pain, trouble breathing.
Less serious side effects may include:
Last reviewed on RxList: 11/5/2013
This monograph has been modified to include the generic and brand name in many instances.
Additional Ofirmev Information
Report Problems to the Food and Drug Administration
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.
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