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acetaminophen
Overview
What is Ofirmev?
Acetaminophen is a non-salicylate antipyretic and non-opioid analgesic agent. Its chemical name is N-acetyl-p-aminophenol. Acetaminophen has a molecular weight of 151.16. Its structural formula is:
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, and 10.4 mg dibasic sodium phosphate, USP. pH is adjusted with hydrochloric acid and/or sodium hydroxide.
What does Ofirmev look like?
What are the available doses of Ofirmev?
OFIRMEV is a sterile, clear, colorless, non-pyrogenic, preservative free, isotonic formulation of acetaminophen intended for intravenous infusion. Each 100 mL glass vial or 100 mL bag contains 1000 mg acetaminophen (10 mg/mL).
What should I talk to my health care provider before I take Ofirmev?
How should I use Ofirmev?
OFIRMEV (acetaminophen) injection is indicated for
OFIRMEV may be given as a single or repeated dose for the treatment of acute pain or fever. No dose adjustment is required when converting between oral acetaminophen and OFIRMEV dosing in adults and adolescents who weigh 50 kg and above. Calculated maximum daily dose of acetaminophen is based on all routes of administration (i.e., intravenous, oral, and rectal) and all products containing acetaminophen. Exceeding the maximum mg/kg daily dose of acetaminophen as described in Tables 1-3 may result in hepatic injury, including the risk of liver failure and death. To avoid the risk of overdose, ensure that the total amount of acetaminophen from all routes and from all sources does not exceed the maximum recommended dose.
What interacts with Ofirmev?
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What are the warnings of Ofirmev?
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What are the precautions of Ofirmev?
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What are the side effects of Ofirmev?
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What should I look out for while using Ofirmev?
Acetaminophen is contraindicated:
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:
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 .
What might happen if I take too much Ofirmev?
How should I store and handle Ofirmev?
Store at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F) [See USP Controlled Room Temperature]. Keep tightly closed (protect from moisture). Protect from light. NDC 43825-102-01 - OFIRMEV (acetaminophen) Injection is supplied in a 100 mL glass vial containing 1000 mg acetaminophen (10 mg/mL) in cartons of 24 vials.NDC 43825-102-03 - OFIRMEV (acetaminophen) Injection is supplied in a 100 mL bag containing 1000 mg acetaminophen (10 mg/mL) in cartons of 24 bags.Do not remove unit from overwrap until ready for use.To open, tear outer wrap at the notch and remove solution bag. After removing the outer wrap, check the container for minute leaks by squeezing the solution bag firmly. If leaks are found, discard the solution because the sterility may be impaired. A small amount of moisture may be present inside the outer wrap.NDC 43825-102-01 - OFIRMEV (acetaminophen) Injection is supplied in a 100 mL glass vial containing 1000 mg acetaminophen (10 mg/mL) in cartons of 24 vials.NDC 43825-102-03 - OFIRMEV (acetaminophen) Injection is supplied in a 100 mL bag containing 1000 mg acetaminophen (10 mg/mL) in cartons of 24 bags.Do not remove unit from overwrap until ready for use.To open, tear outer wrap at the notch and remove solution bag. After removing the outer wrap, check the container for minute leaks by squeezing the solution bag firmly. If leaks are found, discard the solution because the sterility may be impaired. A small amount of moisture may be present inside the outer wrap.NDC 43825-102-01 - OFIRMEV (acetaminophen) Injection is supplied in a 100 mL glass vial containing 1000 mg acetaminophen (10 mg/mL) in cartons of 24 vials.NDC 43825-102-03 - OFIRMEV (acetaminophen) Injection is supplied in a 100 mL bag containing 1000 mg acetaminophen (10 mg/mL) in cartons of 24 bags.Do not remove unit from overwrap until ready for use.To open, tear outer wrap at the notch and remove solution bag. After removing the outer wrap, check the container for minute leaks by squeezing the solution bag firmly. If leaks are found, discard the solution because the sterility may be impaired. A small amount of moisture may be present inside the outer wrap.NDC 43825-102-01 - OFIRMEV (acetaminophen) Injection is supplied in a 100 mL glass vial containing 1000 mg acetaminophen (10 mg/mL) in cartons of 24 vials.NDC 43825-102-03 - OFIRMEV (acetaminophen) Injection is supplied in a 100 mL bag containing 1000 mg acetaminophen (10 mg/mL) in cartons of 24 bags.Do not remove unit from overwrap until ready for use.To open, tear outer wrap at the notch and remove solution bag. After removing the outer wrap, check the container for minute leaks by squeezing the solution bag firmly. If leaks are found, discard the solution because the sterility may be impaired. A small amount of moisture may be present inside the outer wrap.
Clinical Information
Chemical Structure
No Image foundClinical Pharmacology
The precise mechanism of the analgesic and antipyretic properties of acetaminophen is not established but is thought to primarily involve central actions.
Non-Clinical Toxicology
Acetaminophen is contraindicated: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:
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 .
High doses of folic acid may result in decreased serum levels of anticonvulsant drugs.
Vitamin D supplementation should not be given with large amounts of calcium in those with hypercalcemia or conditions that may lead to hyper-calcemia such as hyperparathyroidism and those who form calcium-containing kidney stones.
Zinc can inhibit the absorption of certain antibiotics; take at least 2 hours apart to minimize interactions.
Consult appropriate references for additional specific vitamin-drug interactions.
Administration of acetaminophen in doses higher than recommended may result in hepatic injury, including the risk of liver failure and death . Do not exceed the maximum recommended daily dose of acetaminophen . The maximum recommended daily dose of acetaminophen includes all routes of acetaminophen administration and all acetaminophen-containing products administered, including combination products.
Use caution when administering acetaminophen in patients with the following conditions: hepatic impairment or active hepatic disease, alcoholism, chronic malnutrition, severe hypovolemia (e.g., due to dehydration or blood loss), or severe renal impairment (creatinine clearance ≤ 30 mL/min) .
The following serious adverse reactions are discussed elsewhere in the labeling:
Reference
This information is obtained from the National Institute of Health's Standard Packaging Label drug database.
"https://dailymed.nlm.nih.gov/dailymed/"
While we update our database periodically, we cannot guarantee it is always updated to the latest version.
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