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Xolox
Overview
What is Xolox?
DESCRIPTION
Oxycodone Hydrochloride, USP 10 mg*Acetaminophen, USP 500 mg*10 mg oxycodone HCl is equivalent to 8.9637 mg of oxycodone.
XOLOX (oxycodone and acetaminophen tablets, USP) also contains the following inactive ingredients: croscarmellose sodium, crospovidone, microcrystalline cellulose, povidone, pregelatinized starch, silicon dioxide, and stearic acid.
Oxycodone, 14-hydroxydihydrocodeinone, is a semisynthetic opioid analgesic which occurs as a white, odorless, crystalline powder having a saline, bitter taste. The molecular formula for oxycodone hydrochloride is C18H21NO4•HCl and the molecular weight is 351.82. It is derived from the opium alkaloid thebaine, and may be represented by the following structural formula:
Acetaminophen, 4'-hydroxyacetanilide, is a non-opiate, non-salicylate analgesic and antipyretic which occurs as a white, odorless, crystalline powder, possessing a slightly bitter taste. The molecular formula for acetaminophen is C8H9NO2 and the molecular weight is 151.16. It may be represented by the following structural formula:
What does Xolox look like?
What are the available doses of Xolox?
Sorry No records found.
What should I talk to my health care provider before I take Xolox?
Sorry No records found
How should I use Xolox?
INDICATIONS AND USAGE
Cessation of Therapy
What interacts with Xolox?
Sorry No Records found
What are the warnings of Xolox?
Sorry No Records found
What are the precautions of Xolox?
Sorry No Records found
What are the side effects of Xolox?
Sorry No records found
What should I look out for while using Xolox?
CONTRAINDICATIONS
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. Oxycodone is contraindicated in the setting of suspected or known paralytic ileus.
WARNINGSMisuse, Abuse and Diversion of Opioids
Oxycodone can be abused in a manner similar to other opioid agonists, legal or illicit. This should be considered when prescribing or dispensing XOLOX in situations where the physician or pharmacist is concerned about an increased risk of misuse, abuse, or diversion. Concerns about misuse, addiction, and diversion should not prevent the proper management of pain.
Healthcare professionals should contact their State Professional Licensing Board or State Controlled Substances Authority for information on how to prevent and detect abuse or diversion of this product.
Administration of XOLOX should be closely monitored for the following potentially serious adverse reactions and complications:
Respiratory Depression
In case of respiratory depression, a reversal agent such as naloxone hydrochloride may be utilized.
Head Injury and Increased Intracranial Pressure
Hypotensive Effect
Hepatotoxicity
What might happen if I take too much Xolox?
OVERDOSAGESigns and Symptoms
Treatment
How should I store and handle Xolox?
Store at 25º C (77º F); excursions permitted to 15–30C (59–86F) .HOW SUPPLIEDStore 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 for:WraSerPharmaceuticalsMadison, MS 39110Manufactured by:MIKART, INC.Atlanta, Georgia 30318Code 988C00 Rev.08/08Repackaged by:Rebel Distributors CorpThousand Oaks, CA 91320HOW SUPPLIEDStore 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 for:WraSerPharmaceuticalsMadison, MS 39110Manufactured by:MIKART, INC.Atlanta, Georgia 30318Code 988C00 Rev.08/08Repackaged by:Rebel Distributors CorpThousand Oaks, CA 91320HOW SUPPLIEDStore 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 for:WraSerPharmaceuticalsMadison, MS 39110Manufactured by:MIKART, INC.Atlanta, Georgia 30318Code 988C00 Rev.08/08Repackaged by:Rebel Distributors CorpThousand Oaks, CA 91320HOW SUPPLIEDStore 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 for:WraSerPharmaceuticalsMadison, MS 39110Manufactured by:MIKART, INC.Atlanta, Georgia 30318Code 988C00 Rev.08/08Repackaged by:Rebel Distributors CorpThousand Oaks, CA 91320HOW SUPPLIEDStore 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 for:WraSerPharmaceuticalsMadison, MS 39110Manufactured by:MIKART, INC.Atlanta, Georgia 30318Code 988C00 Rev.08/08Repackaged by:Rebel Distributors CorpThousand Oaks, CA 91320HOW SUPPLIEDStore 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 for:WraSerPharmaceuticalsMadison, MS 39110Manufactured by:MIKART, INC.Atlanta, Georgia 30318Code 988C00 Rev.08/08Repackaged by:Rebel Distributors CorpThousand Oaks, CA 91320HOW SUPPLIEDStore 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 for:WraSerPharmaceuticalsMadison, MS 39110Manufactured by:MIKART, INC.Atlanta, Georgia 30318Code 988C00 Rev.08/08Repackaged by:Rebel Distributors CorpThousand Oaks, CA 91320HOW SUPPLIEDStore 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 for:WraSerPharmaceuticalsMadison, MS 39110Manufactured by:MIKART, INC.Atlanta, Georgia 30318Code 988C00 Rev.08/08Repackaged by:Rebel Distributors CorpThousand Oaks, CA 91320HOW SUPPLIEDStore 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 for:WraSerPharmaceuticalsMadison, MS 39110Manufactured by:MIKART, INC.Atlanta, Georgia 30318Code 988C00 Rev.08/08Repackaged by:Rebel Distributors CorpThousand Oaks, CA 91320HOW SUPPLIEDStore 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 for:WraSerPharmaceuticalsMadison, MS 39110Manufactured by:MIKART, INC.Atlanta, Georgia 30318Code 988C00 Rev.08/08Repackaged by:Rebel Distributors CorpThousand Oaks, CA 91320
Clinical Information
Chemical Structure
No Image foundClinical Pharmacology
CLINICAL PHARMACOLOGYCentral Nervous System
Acetaminophen is a non-opiate, non-salicylate analgesic and antipyretic. The site and mechanism for the analgesic effect of acetaminophen has not been determined. The antipyretic effect of acetaminophen is accomplished through the inhibition of endogenous pyrogen action on the hypothalamic heat-regulating centers.
Gastrointestinal Tract and Other Smooth Muscle
Cardiovascular System
Pharmacokinetics
Absorption of acetaminophen is rapid and almost complete from the GI tract after oral administration. With overdosage, absorption is complete in 4 hours. Acetaminophen is relatively uniformly distributed throughout most body fluids. Binding of the drug to plasma proteins is variable; only 20% to 50% may be bound at the concentrations encountered during acute intoxication.
Metabolism and Elimination
Acetaminophen is metabolized in the liver via cytochrome P450 microsomal enzyme. About 80-85% of the acetaminophen in the body is conjugated principally with glucuronic acid and to a lesser extent with sulfuric acid and cysteine. After hepatic conjugation, 90 to 100% of the drug is recovered in the urine within the first day.
About 4% of acetaminophen is metabolized via cytochrome P450 oxidase to a toxic metabolite which is further detoxified by conjugation with glutathione, present in a fixed amount. It is believed that the toxic metabolite NAPQI (N acetyl-p-benzoquinoneimine, N-acetylimidoquinone) is responsible for liver necrosis. High doses of acetaminophen may deplete the glutathione stores so that inactivation of the toxic metabolite is decreased. At high doses, the capacity of metabolic pathways for conjugation with glucuronic acid and sulfuric acid may be exceeded, resulting in increased metabolism of acetaminophen by alternate pathways.
Non-Clinical Toxicology
CONTRAINDICATIONSOxycodone 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. Oxycodone is contraindicated in the setting of suspected or known paralytic ileus.
WARNINGSMisuse, Abuse and Diversion of Opioids
Oxycodone can be abused in a manner similar to other opioid agonists, legal or illicit. This should be considered when prescribing or dispensing XOLOX in situations where the physician or pharmacist is concerned about an increased risk of misuse, abuse, or diversion. Concerns about misuse, addiction, and diversion should not prevent the proper management of pain.
Healthcare professionals should contact their State Professional Licensing Board or State Controlled Substances Authority for information on how to prevent and detect abuse or diversion of this product.
Administration of XOLOX should be closely monitored for the following potentially serious adverse reactions and complications:
Respiratory Depression
In case of respiratory depression, a reversal agent such as naloxone hydrochloride may be utilized.
Head Injury and Increased Intracranial Pressure
Hypotensive Effect
Hepatotoxicity
This drug may enhance the effects of other narcotic analgesics, alcohol, general anesthetics, tranquilizers such as chlordiazepoxide, sedative-hypnotics, or other CNS depressants, causing increased CNS depression.
Hepatic Impairment
Renal Impairment
ADVERSE REACTIONS
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.
Hypersensitivity reactionsmay include: Skin eruptions, urticarial, erythematous skin reactions. Hematologic reactions may include: Thrombocytopenia, neutropenia, pancytopenia, hemolytic anemia. Rare cases of agranulocytosis has likewise been associated with acetaminophen use. In high doses, the most serious adverse effect is a dose-dependent, potentially fatal hepatic necrosis. Renal tubular necrosis and hypoglycemic coma also may occur.
Other adverse reactions obtained from postmarketing experiences with XOLOX are listed by organ system and in decreasing order of severity and/or frequency as follows:
Body as a Whole
Cardiovascular
Central and Peripheral Nervous System
Fluid and Electrolyte
Gastrointestinal
Hepatic
Hearing and Vestibular
Hematologic
Hypersensitivity
Metabolic and Nutritional
Musculoskeletal
Ocular
Psychiatric
Respiratory System
Skin and Appendages
Urogenital
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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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. 315.72Tips
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Interactions
Interactions
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