Oxycodone and Aspirin

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Overview

What is Oxycodone and Aspirin?

Each oxycodone and aspirin tablet contains:Oxycodone Hydrochloride, USP       4.8355 mg*Aspirin, USP                                      325mg

*4.8355 mg oxycodone HCl is equivalent to 4.3346 mg of oxycodone as the free base.

Oxycodone and aspirin tablets also contain the following inactive ingredients: corn starch, D&C Yellow #10 Aluminum Lake and microcrystalline cellulose.

The oxycodone hydrochloride component is Morphinan-6-one, 4,5-epoxy-14-hydroxy-3-methoxy-17-methyl-, hydrochloride, (5α)-., a white to off-white, hygroscopic crystals or powder, odorless, soluble in water; slightly soluble in alcohol and is represented by the following structural formula:

CHNO•HCl                              MW 351.82

The aspirin component is 2-(acetyloxy)-, Benzoic acid, a white crystal, commonly tabular or needle- like, or white, crystalline powder. Is odorless or has a faint odor. Is stable in dry air; in moist air it gradually hydrolyzes to salicylic and acetic acids. Slightly soluble in water; freely soluble in alcohol; soluble in chloroform and in ether; sparingly soluble in absolute ether and is represented by the following structural formula:

CHO                                        MW 180.16

What does Oxycodone and Aspirin look like?

What are the available doses of Oxycodone and Aspirin?

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What should I talk to my health care provider before I take Oxycodone and Aspirin?

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How should I use Oxycodone and Aspirin?

Oxycodone and aspirin tablets are indicated for the management of moderate to moderately severe pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate.

Limitations of Use

Initiate the dosing regimen for each patient individually, taking into account the patient's severity of pain, patient response, prior analgesic treatment experience, and risk factors for addiction, abuse, and misuse [see ].

Monitor patients closely for respiratory depression, especially within the first 24-72 hours of initiating therapy and following dosage increases with oxycodone and aspirin tablets and adjust the dosage accordingly [see ].

What interacts with Oxycodone and Aspirin?

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What are the warnings of Oxycodone and Aspirin?

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What are the precautions of Oxycodone and Aspirin?

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What are the side effects of Oxycodone and Aspirin?

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What should I look out for while using Oxycodone and Aspirin?

Oxycodone and aspirin tablets are contraindicated in patients with:

What might happen if I take too much Oxycodone and Aspirin?

Clinical Presentation

In acute salicylate overdose, severe acid-base and electrolyte disturbances may occur and are complicated by hyperthermia and dehydration, and coma. Respiratory alkalosis occurs early while hyperventilation is present, but is quickly followed by metabolic acidosis. Serious symptoms such as depression, coma, and respiratory failure progress rapidly.

Salicylism (chronic salicylate toxicity) may be noted by symptoms such as dizziness, tinnitus, difficulty hearing, nausea, vomiting, diarrhea, and mental confusion. More severe salicylism may result in respiratory alkalosis.

Treatment of Overdose

The opioid antagonists, naloxone or nalmefene, are specific antidotes to respiratory depression resulting from opioid overdose. For clinically significant respiratory or circulatory depression secondary to oxycodone and aspirin tablet overdose, administer an opioid antagonist. Opioid antagonists should not be administered in the absence of clinically significant respiratory or circulatory depression secondary to oxycodone and aspirin tablet overdose.

Because the duration of opioid reversal is expected to be less than the duration of action of oxycodone and aspirin in oxycodone and aspirin tablets, carefully monitor the patient until spontaneous respiration is reliably re-established. If the response to an opioid antagonist is suboptimal or only brief in nature, administer additional antagonist as directed by the product’s prescribing information.

In an individual physically dependent on opioids, administration of the recommended usual dosage of the antagonist will precipitate an acute withdrawal syndrome. The severity of the withdrawal symptoms experienced will depend on the degree of physical dependence and the dose of the antagonist administered. If a decision is made to treat serious respiratory depression in the physically dependent patient, administration of the antagonist should be begun with care and by titration with smaller than usual doses of the antagonist.

How should I store and handle Oxycodone and Aspirin?

Store original packages at room temperature; avoid excessive heat.Oxycodone and Aspirin Tablets, USP are yellow, round biconvex tablets, debossed with “”and “”on one side and scored on the other side, supplied in bottles of 100 (NDC 0591-3551-01). Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Dispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure (as required). DEA Order Form Required. Manufactured by:Actavis Laboratories FL, Inc. Fort Lauderdale, FL 33314 USA Distributed by:Actavis Pharma, Inc.Parsippany, NJ 07054 USA Revised: April 2016Oxycodone and Aspirin Tablets, USP are yellow, round biconvex tablets, debossed with “”and “”on one side and scored on the other side, supplied in bottles of 100 (NDC 0591-3551-01). Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Dispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure (as required). DEA Order Form Required. Manufactured by:Actavis Laboratories FL, Inc. Fort Lauderdale, FL 33314 USA Distributed by:Actavis Pharma, Inc.Parsippany, NJ 07054 USA Revised: April 2016Oxycodone and Aspirin Tablets, USP are yellow, round biconvex tablets, debossed with “”and “”on one side and scored on the other side, supplied in bottles of 100 (NDC 0591-3551-01). Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Dispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure (as required). DEA Order Form Required. Manufactured by:Actavis Laboratories FL, Inc. Fort Lauderdale, FL 33314 USA Distributed by:Actavis Pharma, Inc.Parsippany, NJ 07054 USA Revised: April 2016Oxycodone and Aspirin Tablets, USP are yellow, round biconvex tablets, debossed with “”and “”on one side and scored on the other side, supplied in bottles of 100 (NDC 0591-3551-01). Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Dispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure (as required). DEA Order Form Required. Manufactured by:Actavis Laboratories FL, Inc. Fort Lauderdale, FL 33314 USA Distributed by:Actavis Pharma, Inc.Parsippany, NJ 07054 USA Revised: April 2016Oxycodone and Aspirin Tablets, USP are yellow, round biconvex tablets, debossed with “”and “”on one side and scored on the other side, supplied in bottles of 100 (NDC 0591-3551-01). Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Dispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure (as required). DEA Order Form Required. Manufactured by:Actavis Laboratories FL, Inc. Fort Lauderdale, FL 33314 USA Distributed by:Actavis Pharma, Inc.Parsippany, NJ 07054 USA Revised: April 2016Oxycodone and Aspirin Tablets, USP are yellow, round biconvex tablets, debossed with “”and “”on one side and scored on the other side, supplied in bottles of 100 (NDC 0591-3551-01). Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Dispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure (as required). DEA Order Form Required. Manufactured by:Actavis Laboratories FL, Inc. Fort Lauderdale, FL 33314 USA Distributed by:Actavis Pharma, Inc.Parsippany, NJ 07054 USA Revised: April 2016Oxycodone and Aspirin Tablets, USP are yellow, round biconvex tablets, debossed with “”and “”on one side and scored on the other side, supplied in bottles of 100 (NDC 0591-3551-01). Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Dispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure (as required). DEA Order Form Required. Manufactured by:Actavis Laboratories FL, Inc. Fort Lauderdale, FL 33314 USA Distributed by:Actavis Pharma, Inc.Parsippany, NJ 07054 USA Revised: April 2016Oxycodone and Aspirin Tablets, USP are yellow, round biconvex tablets, debossed with “”and “”on one side and scored on the other side, supplied in bottles of 100 (NDC 0591-3551-01). Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Dispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure (as required). DEA Order Form Required. Manufactured by:Actavis Laboratories FL, Inc. Fort Lauderdale, FL 33314 USA Distributed by:Actavis Pharma, Inc.Parsippany, NJ 07054 USA Revised: April 2016

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Clinical Information

Chemical Structure

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Clinical Pharmacology

Oxycodone is a semisynthetic pure opioid agonist whose principal therapeutic action is analgesia. Other pharmacological effects of oxycodone include anxiolysis, euphoria and feelings of relaxation. These effects are mediated by receptors (notably μ and κ) in the central nervous system for endogenous opioid-like compounds such as endorphins and enkephalins. Oxycodone produces respiratory depression through direct activity at respiratory centers in the brain stem and depresses the cough reflex by direct effect on the center of the medulla.

Aspirin (acetylsalicylic acid) works by inhibiting the body’s production of prostaglandins, including prostaglandins involved in inflammation. Prostaglandins cause pain sensations by stimulating muscle contractions and dilating blood vessels throughout the body. In the CNS, aspirin works on the hypothalamus heat-regulating center to reduce fever, however, other mechanisms may be involved.

Non-Clinical Toxicology

Oxycodone and aspirin tablets are contraindicated in patients with:

Plasma levels of anticonvulsant agents may become subtherapeutic during cisplatin therapy.

In a randomized trial in advanced ovarian cancer, response duration was adversely affected when pyridoxine was used in combination with altretamine (hexamethylmelamine) and cisplatin.

Opioid analgesics should be used with caution when combined with CNS depressant 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.

Oxycodone and aspirin tablets should be given with caution to patients with CNS depression, elderly or debilitated patients, patients with severe impairment of hepatic, pulmonary, or renal function, hypothyroidism, Addison’s disease, prostatic hypertrophy, urethral stricture, acute alcoholism, delirium tremens, kyphoscoliosis with respiratory depression, myxedema, and toxic psychosis.

Oxycodone and aspirin tablets may obscure the diagnosis or clinical course in patients with acute abdominal conditions. Oxycodone may aggravate convulsions in patients with convulsive disorders, and all opioids may induce or aggravate seizures in some clinical settings.

Following administration of oxycodone and aspirin tablets, anaphylactic reactions have been reported in patients with a known hypersensitivity to codeine, a compound with a structure similar to morphine and oxycodone. The frequency of this possible cross-sensitivity is unknown.

Aspirin has been associated with elevated hepatic enzymes, blood urea nitrogen and serum creatinine, hyperkalemia, proteinuria, and prolonged bleeding time.

Serious adverse reactions that may be associated with oxycodone and aspirin tablet use include respiratory depression, apnea, respiratory arrest, circulatory depression, hypotension, and shock [see ].

The most frequently observed non-serious adverse reactions include lightheadedness, dizziness, drowsiness or sedation, nausea, and vomiting. These effects seem to be more prominent in ambulatory than in nonambulatory patients, and some of these adverse reactions may be alleviated if the patient lies down. Other adverse reactions include euphoria, dysphoria, constipation and pruritus.

Aspirin may increase the likelihood of hemorrhage due to its effect on the gastric mucosa and platelet function. Furthermore, aspirin has the potential to cause anaphylaxis in hypersensitive patients as well as angioedema especially in patients with chronic urticaria. Other adverse reactions due to aspirin use include anorexia, reversible hepatotoxicity, leukopenia, thrombocytopenia, purpura, decreased plasma iron concentration, and shortened erythrocyte survival time.

Other adverse reactions obtained from postmarketing experiences with oxycodone and aspirin tablets are listed by organ system and in decreasing order of severity and/or frequency as follows:

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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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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).

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