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OXECTA

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Overview

What is OXECTA?

OXECTA (oxycodone HCl, USP) tablets are an immediate-release opioid analgesic intended for oral administration only. OXECTA contains oxycodone HCl, USP as the active analgesic ingredient. The tablets are round, convex, white and debossed with the strength (5 or 7.5) on one side and King Logo on the other side. OXECTA also contain colloidal silicon dioxide NF; crospovidone NF; magnesium stearate NF; microcrystalline cellulose NF; polyethylene oxide NF; and sodium lauryl sulfate NF.

Chemically, oxycodone HCl is 4,5α-epoxy-14-hydroxy-3-methoxy-17-methylmorphinan-6-one HCl, a white, odorless crystalline powder. Oxycodone HCl is soluble in water (1 g in 6 to 7 mL). The molecular weight of oxycodone HCl is 351.82. The molecular formula for oxycodone HCl is CHNO•HCl, and the structure is:



What does OXECTA look like?



What are the available doses of OXECTA?

Tablets: 5 mg and 7.5 mg (oxycodone HCl) ()

What should I talk to my health care provider before I take OXECTA?

How should I use OXECTA?

OXECTA is an immediate-release oral formulation of oxycodone HCl indicated for the management of acute and chronic moderate to severe pain where the use of an opioid analgesic is appropriate.

Selection of patients for treatment with OXECTA should be governed by the same principles that apply to the use of other potent opioid analgesics. Opioid analgesics given on a fixed-dosage schedule have a narrow therapeutic index in certain patient populations, especially when combined with other drugs, and should be reserved for cases where the benefits of opioid analgesia outweigh the known risks of respiratory depression, altered mental state, and postural hypotension. Healthcare providers should individualize treatment in every case, using non-opioid analgesics, opioids and/or combination products when necessary, and chronic opioid therapy with drugs such as OXECTA in a progressive plan of pain management such as outlined by the World Health Organization, the Agency for Health Care Policy and Research, and the American Pain Society.

OXECTA must be swallowed whole. Take each tablet with enough water to ensure complete swallowing immediately after placing in the mouth .  OXECTA is not amenable to crushing and dissolution. Do not administer OXECTA via nasogastric, gastric or other feeding tubes as it may cause obstruction of feeding tubes. 


What interacts with OXECTA?

Sorry No Records found


What are the warnings of OXECTA?

Sorry No Records found


What are the precautions of OXECTA?

Sorry No Records found


What are the side effects of OXECTA?

Sorry No records found


What should I look out for while using OXECTA?

OXECTA is contraindicated in patients with respiratory depression in unmonitored settings and in the absence of resuscitative equipment.

OXECTA is contraindicated in any patient who has or is suspected of having paralytic ileus.

OXECTA is contraindicated in patients with acute or severe bronchial asthma or hypercarbia.

OXECTA is contraindicated in patients with known hypersensitivity to oxycodone, oxycodone salts, or any components of the product.


What might happen if I take too much OXECTA?


How should I store and handle OXECTA?

Handling OXECTA (oxycodone HCl, USP) is supplied as round, convex, white tablets as follows:5 mg tablets debossed with the strength "5" on one side and the King Logo on the other side.NDC7.5 mg tablets debossed with the strength "7.5" on one side and the King Logo on the other side.NDCDispense in tight container as defined in the USP, with a child-resistant closure.Store at 25ºC (77ºF); with excursions permitted to 15º-30ºC (59º-86ºF) [See USP Controlled Room Temperature].Protect from moisture.HandlingAll opioids, including OXECTA, are liable to diversion and misuse both by the general public and healthcare workers and must be handled accordingly.DEA Schedule II Order Form RequiredPrescribing Information as of January 2014OXECTA (oxycodone HCl, USP) is supplied as round, convex, white tablets as follows:5 mg tablets debossed with the strength "5" on one side and the King Logo on the other side.NDC7.5 mg tablets debossed with the strength "7.5" on one side and the King Logo on the other side.NDCDispense in tight container as defined in the USP, with a child-resistant closure.Store at 25ºC (77ºF); with excursions permitted to 15º-30ºC (59º-86ºF) [See USP Controlled Room Temperature].Protect from moisture.HandlingAll opioids, including OXECTA, are liable to diversion and misuse both by the general public and healthcare workers and must be handled accordingly.DEA Schedule II Order Form RequiredPrescribing Information as of January 2014OXECTA (oxycodone HCl, USP) is supplied as round, convex, white tablets as follows:5 mg tablets debossed with the strength "5" on one side and the King Logo on the other side.NDC7.5 mg tablets debossed with the strength "7.5" on one side and the King Logo on the other side.NDCDispense in tight container as defined in the USP, with a child-resistant closure.Store at 25ºC (77ºF); with excursions permitted to 15º-30ºC (59º-86ºF) [See USP Controlled Room Temperature].Protect from moisture.HandlingAll opioids, including OXECTA, are liable to diversion and misuse both by the general public and healthcare workers and must be handled accordingly.DEA Schedule II Order Form RequiredPrescribing Information as of January 2014OXECTA (oxycodone HCl, USP) is supplied as round, convex, white tablets as follows:5 mg tablets debossed with the strength "5" on one side and the King Logo on the other side.NDC7.5 mg tablets debossed with the strength "7.5" on one side and the King Logo on the other side.NDCDispense in tight container as defined in the USP, with a child-resistant closure.Store at 25ºC (77ºF); with excursions permitted to 15º-30ºC (59º-86ºF) [See USP Controlled Room Temperature].Protect from moisture.HandlingAll opioids, including OXECTA, are liable to diversion and misuse both by the general public and healthcare workers and must be handled accordingly.DEA Schedule II Order Form RequiredPrescribing Information as of January 2014OXECTA (oxycodone HCl, USP) is supplied as round, convex, white tablets as follows:5 mg tablets debossed with the strength "5" on one side and the King Logo on the other side.NDC7.5 mg tablets debossed with the strength "7.5" on one side and the King Logo on the other side.NDCDispense in tight container as defined in the USP, with a child-resistant closure.Store at 25ºC (77ºF); with excursions permitted to 15º-30ºC (59º-86ºF) [See USP Controlled Room Temperature].Protect from moisture.HandlingAll opioids, including OXECTA, are liable to diversion and misuse both by the general public and healthcare workers and must be handled accordingly.DEA Schedule II Order Form RequiredPrescribing Information as of January 2014OXECTA (oxycodone HCl, USP) is supplied as round, convex, white tablets as follows:5 mg tablets debossed with the strength "5" on one side and the King Logo on the other side.NDC7.5 mg tablets debossed with the strength "7.5" on one side and the King Logo on the other side.NDCDispense in tight container as defined in the USP, with a child-resistant closure.Store at 25ºC (77ºF); with excursions permitted to 15º-30ºC (59º-86ºF) [See USP Controlled Room Temperature].Protect from moisture.HandlingAll opioids, including OXECTA, are liable to diversion and misuse both by the general public and healthcare workers and must be handled accordingly.DEA Schedule II Order Form RequiredPrescribing Information as of January 2014OXECTA (oxycodone HCl, USP) is supplied as round, convex, white tablets as follows:5 mg tablets debossed with the strength "5" on one side and the King Logo on the other side.NDC7.5 mg tablets debossed with the strength "7.5" on one side and the King Logo on the other side.NDCDispense in tight container as defined in the USP, with a child-resistant closure.Store at 25ºC (77ºF); with excursions permitted to 15º-30ºC (59º-86ºF) [See USP Controlled Room Temperature].Protect from moisture.HandlingAll opioids, including OXECTA, are liable to diversion and misuse both by the general public and healthcare workers and must be handled accordingly.DEA Schedule II Order Form RequiredPrescribing Information as of January 2014OXECTA (oxycodone HCl, USP) is supplied as round, convex, white tablets as follows:5 mg tablets debossed with the strength "5" on one side and the King Logo on the other side.NDC7.5 mg tablets debossed with the strength "7.5" on one side and the King Logo on the other side.NDCDispense in tight container as defined in the USP, with a child-resistant closure.Store at 25ºC (77ºF); with excursions permitted to 15º-30ºC (59º-86ºF) [See USP Controlled Room Temperature].Protect from moisture.HandlingAll opioids, including OXECTA, are liable to diversion and misuse both by the general public and healthcare workers and must be handled accordingly.DEA Schedule II Order Form RequiredPrescribing Information as of January 2014OXECTA (oxycodone HCl, USP) is supplied as round, convex, white tablets as follows:5 mg tablets debossed with the strength "5" on one side and the King Logo on the other side.NDC7.5 mg tablets debossed with the strength "7.5" on one side and the King Logo on the other side.NDCDispense in tight container as defined in the USP, with a child-resistant closure.Store at 25ºC (77ºF); with excursions permitted to 15º-30ºC (59º-86ºF) [See USP Controlled Room Temperature].Protect from moisture.HandlingAll opioids, including OXECTA, are liable to diversion and misuse both by the general public and healthcare workers and must be handled accordingly.DEA Schedule II Order Form RequiredPrescribing Information as of January 2014OXECTA (oxycodone HCl, USP) is supplied as round, convex, white tablets as follows:5 mg tablets debossed with the strength "5" on one side and the King Logo on the other side.NDC7.5 mg tablets debossed with the strength "7.5" on one side and the King Logo on the other side.NDCDispense in tight container as defined in the USP, with a child-resistant closure.Store at 25ºC (77ºF); with excursions permitted to 15º-30ºC (59º-86ºF) [See USP Controlled Room Temperature].Protect from moisture.HandlingAll opioids, including OXECTA, are liable to diversion and misuse both by the general public and healthcare workers and must be handled accordingly.DEA Schedule II Order Form RequiredPrescribing Information as of January 2014OXECTA (oxycodone HCl, USP) is supplied as round, convex, white tablets as follows:5 mg tablets debossed with the strength "5" on one side and the King Logo on the other side.NDC7.5 mg tablets debossed with the strength "7.5" on one side and the King Logo on the other side.NDCDispense in tight container as defined in the USP, with a child-resistant closure.Store at 25ºC (77ºF); with excursions permitted to 15º-30ºC (59º-86ºF) [See USP Controlled Room Temperature].Protect from moisture.HandlingAll opioids, including OXECTA, are liable to diversion and misuse both by the general public and healthcare workers and must be handled accordingly.DEA Schedule II Order Form RequiredPrescribing Information as of January 2014OXECTA (oxycodone HCl, USP) is supplied as round, convex, white tablets as follows:5 mg tablets debossed with the strength "5" on one side and the King Logo on the other side.NDC7.5 mg tablets debossed with the strength "7.5" on one side and the King Logo on the other side.NDCDispense in tight container as defined in the USP, with a child-resistant closure.Store at 25ºC (77ºF); with excursions permitted to 15º-30ºC (59º-86ºF) [See USP Controlled Room Temperature].Protect from moisture.HandlingAll opioids, including OXECTA, are liable to diversion and misuse both by the general public and healthcare workers and must be handled accordingly.DEA Schedule II Order Form RequiredPrescribing Information as of January 2014


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Clinical Information

Chemical Structure

No Image found
Clinical Pharmacology

Oxycodone HCl is a pure opioid agonist and is relatively selective for the mu receptor, although it can interact with other opioid receptors at higher doses. The principal therapeutic action of oxycodone is analgesia. Like all pure opioid agonists, there is no ceiling effect to analgesia.

Non-Clinical Toxicology
OXECTA is contraindicated in patients with respiratory depression in unmonitored settings and in the absence of resuscitative equipment.

OXECTA is contraindicated in any patient who has or is suspected of having paralytic ileus.

OXECTA is contraindicated in patients with acute or severe bronchial asthma or hypercarbia.

OXECTA is contraindicated in patients with known hypersensitivity to oxycodone, oxycodone salts, or any components of the product.

Antacids containing magnesium trisilicate, when administered concomitantly with nitrofurantoin, reduce both the rate and extent of absorption. The mechanism for this interaction probably is adsorption of nitrofurantoin onto the surface of magnesium trisilicate.

Uricosuric drugs, such as probenecid and sulfinpyrazone, can inhibit renal tubular secretion of nitrofurantoin. The resulting increase in nitrofurantoin serum levels may increase toxicity, and the decreased urinary levels could lessen its efficacy as a urinary tract antibacterial.

Respiratory depression is the primary risk of OXECTA. Respiratory depression occurs more frequently in elderly or debilitated patients, in those suffering from conditions accompanied by hypoxia, hypercapnia, or upper airway obstruction, or following large initial doses of opioids given to non-tolerant patients, or when opioids are given in conjunction with other agents that depress respiration (e.g., benzodiazepines, tricyclic antidepressants, and sedative-hypnotics).

OXECTA must be used with extreme caution in patients with chronic obstructive pulmonary disease or cor pulmonale, and in patients having substantially decreased respiratory reserve (e.g., severe kyphoscoliosis), hypoxia, hypercapnia, or pre-existing respiratory depression. In such patients, even usual therapeutic doses of OXECTA may decrease respiratory drive to the point of apnea. In these patients, alternative non-opioid analgesics should be considered, and opioids must be employed only under careful medical supervision at the lowest effective dose.

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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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Professional

Clonazepam Description Each single-scored tablet, for oral administration, contains 0.5 mg, 1 mg, or 2 mg Clonazepam, USP, a benzodiazepine. Each tablet also contains corn starch, lactose monohydrate, magnesium stearate, microcrystalline cellulose, and povidone. Clonazepam tablets USP 0.5 mg contain Yellow D&C No. 10 Aluminum Lake. Clonazepam tablets USP 1 mg contain Yellow D&C No. 10 Aluminum Lake, as well as FD&C Blue No. 1 Aluminum Lake. Chemically, Clonazepam, USP is 5-(o-chlorophenyl)-1,3-dihydro-7-nitro-2H-1,4-benzodiazepin-2-one. It is a light yellow crystalline powder. It has the following structural formula: C15H10ClN3O3 M.W. 315.72
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Tips

Tips

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Interactions

Interactions

A total of 440 drugs (1549 brand and generic names) are known to interact with Imbruvica (ibrutinib). 228 major drug interactions (854 brand and generic names) 210 moderate drug interactions (691 brand and generic names) 2 minor drug interactions (4 brand and generic names) Show all medications in the database that may interact with Imbruvica (ibrutinib).