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Oxecta

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Oxecta

Oxecta Side Effects Center

Medical Editor: William C. Shiel Jr., MD, FACP, FACR

Oxecta (oxycodone HCl, USP) is indicated for the management of acute and chronic moderate to severe pain. Common side effects from use of Oxecta include abdominal pain, accidental injury, allergic reaction, back pain, chills and fever, fever, flu syndrome, infection, neck pain, pain, photosensitivity reaction, and sepsis.

Oxecta must be swallowed whole. Take each tablet with enough water to ensure complete swallowing immediately after placing in the mouth. Patients who have not been receiving opioid analgesics should be started on Oxecta in a dosing range of 5 to 15 mg every 4 to 6 hours as needed for pain. The dose should be titrated based upon the individual patient's response to their initial dose of Oxecta. Patients with chronic pain may need to be dosed at the lowest dosage level that will achieve acceptable analgesia and tolerable adverse reactions, on an around-the-clock basis rather than on an as needed basis.

There are no adequate and well-controlled studies of oxycodone use during pregnancy. Based on limited human data in the literature, oxycodone does not appear to increase the risk of congenital malformations. Oxecta should be used during pregnancy only if clearly needed. Opioids cross the placenta and may produce respiratory depression and psycho-physiologic effects in neonates. Low levels of oxycodone have been detected in maternal milk. The amount of oxycodone delivered to the infant depends on the plasma concentration of the mother, the amount of milk ingested by the infant. There is potential for serious adverse reactions in nursing infants from oxycodone that includes respiratory depression, sedation and potentially withdrawal symptoms when the mother stops taking oxycodone HC1. As such, one should consider either discontinuing nursing or discontinuing the drug, while taking into account the importance of the drug to the mother.

Our Oxecta Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What is Prescribing information?

The FDA package insert formatted in easy-to-find categories for health professionals and clinicians.

Oxecta FDA Prescribing Information: Side Effects
(Adverse Reactions)

SIDE EFFECTS

Clinical Studies

Because clinical trials are conducted under widely varying conditions, the adverse reaction rates observed in clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice.

Serious adverse reactions that may be associated with OXECTA include: respiratory depression, respiratory arrest, circulatory depression, cardiac arrest, hypotension, and/or shock [see WARNINGS AND PRECAUTIONS and OVERDOSAGE].

The common adverse reactions seen on initiation of therapy with OXECTA are dose-dependent, and their frequency depends on the clinical setting, the patient's level of opioid tolerance, and host factors specific to the individual. They should be expected and managed as a part of opioid therapy. The most frequent of the adverse reactions include nausea, constipation, vomiting, headache, and pruritus.

The frequency of adverse reactions during initiation of opioid therapy may be minimized by careful individualization of starting dosage, slow titration and the avoidance of large rapid swings in plasma concentration of the opioid. Many of these adverse reactions will abate as therapy is continued and some degree of tolerance is developed, but others may be expected to remain throughout therapy.

In all patients for whom dosing information was available (n=191) from open-label and double-blind studies involving oxycodone, the following adverse reactions were recorded in oxycodone-treated patients with an incidence of ≥ 3%. In descending order of frequency they were: nausea, constipation, vomiting, headache, pruritus, insomnia, dizziness, asthenia, and somnolence.

The following adverse reactions occurred in less than 3% of patients involved in clinical trials with oxycodone:

Body as a Whole: abdominal pain, accidental injury, allergic reaction, back pain, chills and fever, fever, flu syndrome, infection, neck pain, pain, photosensitivity reaction, and sepsis.

Cardiovascular: deep vein thrombophlebitis, heart failure, hemorrhage, hypotension, migraine, palpitation, and tachycardia.

Digestive: anorexia, diarrhea, dyspepsia, dysphagia, gingivitis, glossitis, and nausea and vomiting.

Hematopoietic and Lymphatic: anemia and leukopenia.

Metabolism and Nutrition: edema, gout, hyperglycemia, iron deficiency anemia, and peripheral edema.

Musculoskeletal: arthralgia, arthritis, bone pain, myalgia, and pathological fracture.

Nervous System: agitation, anxiety, confusion, dry mouth, hypertonia, hypesthesia, nervousness, neuralgia, personality disorder, tremor, and vasodilation.

Respiratory: bronchitis, cough increased, dyspnea, epistaxis, laryngismus, lung disorder, pharyngitis, rhinitis, and sinusitis.

Skin and Appendages: herpes simplex, rash, sweating, and urticaria.

Special Senses: amblyopia.

Urogenital: urinary tract infection.

Read the entire FDA prescribing information for Oxecta (Oxycodone HCl, USP Tablets) »

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Additional Oxecta 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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