Finished product reference
Acetaminophen / Oxycodone Hydrochloride
Tablet · Oral · 325 mg/5 mg
- List code
- 52632
WARNING Hepatotoxicity 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 4000 milligrams per day, and often involve more than one acetaminophen-containing product.
Indications
INDICATIONS AND USAGE Oxycodone and Acetaminophen Tablets is indicated for the relief of moderate to moderately severe pain.
Dosage and administration (summary)
DOSAGE AND ADMINISTRATION Dosage should be adjusted according to the severity of the pain and the response of the patient. It may occasionally be necessary to exceed the usual dosage recommended below in cases of more severe pain or in those patients who have become tolerant to the analgesic effect of opioids. If pain is constant, the opioid analgesic should be given at regular intervals on an around-the-clock schedule. Oxycodone and Acetaminophen Tablets are given orally. Oxycodone and Acetaminophen Tablets, USP, 5 mg/325 mg; Oxycodone and Acetaminophen Tablets, USP, 7.5 mg/325 mg.
Contraindications
CONTRAINDICATIONS Oxycodone and Acetaminophen Tablets should not be administered to patients with known hypersensitivity to oxycodone, acetaminophen, or any other component of this product. Oxycodone is contraindicated in any situation where opioids are contraindicated including patients with significant respiratory depression (in unmonitored settings or the absence of resuscitative equipment) and patients with acute or severe bronchial asthma or hypercarbia.
Warnings and precautions
WARNINGS Misuse, Abuse and Diversion of Opioids Oxycodone is an opioid agonist of the morphine-type. Such drugs are sought by drug abusers and people with addiction disorders and are subject to criminal diversion. Oxycodone can be abused in a manner similar to other opioid agonists, legal or illicit. This should be considered when prescribing or dispensing Oxycodone and Acetaminophen Tablets in situations where the physician or pharmacist is concerned about an increased risk of misuse, abuse, or diversion.
Pregnancy
Pregnancy Teratogenic Effects Pregnancy Category C Animal reproductive studies have not been conducted with Oxycodone and Acetaminophen Tablets. It is also not known whether Oxycodone and Acetaminophen Tablets can cause fetal harm when administered to a pregnant woman or can affect reproductive capacity.
Storage and supply
Store at 20° to 25°C (68° to 77°F). . Dispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure (as required).
Source: Oxycodone And Acetaminophen (Oxycodone And Acetaminophen) — US FDA prescribing information, 2019-11-01, DailyMed. Summarised and shortened; the full label governs. Iranian registration, indications and labelling may differ.
Other presentations of the same active ingredient
Reference information for professional sourcing and registration enquiries, not medical advice or a promotion. Drug information is condensed from US FDA prescribing information (public domain, via openFDA and DailyMed) and does not replace the product’s approved labelling in Iran. Availability, origin and documentation are confirmed per enquiry.
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