For Oral Use
Description for Tylox
Each capsule of TYLOX (
Oxycodone Hydrochloride USP..........5 mg*
Warning — May be habit forming.
Acetaminophen USP..........................500 mg
Inactive ingredients: docusate sodium, gelatin, magnesium stearate, sodium benzoate, sodium metabisulfite†, corn starch, FD&C Blue No. 1, FD&C Red No. 3, FD&C Red No. 40, and titanium dioxide.
Acetaminophen occurs as a white, odorless crystalline powder, possessing a slightly bitter taste.
The oxycodone component is 14-hydroxydihydrocodeinone, a white, odorless crystalline powder having a saline, bitter taste. It is derived from the opium alkaloid thebaine, and may be represented by the following structural formula:
*5 mg oxycodone hydrochloride is equivalent to 4.4815 mg oxycodone
† See
Uses for Tylox
TYLOX (oxycodone and acetaminophen capsules) (oxycodone and acetaminophen capsules) are indicated for the relief of moderate to moderately severe pain.
Dosage for Tylox
Dosage should be adjusted according to the severity of the pain and the response of the patient. However, it should be kept in mind that tolerance to oxycodone can develop with continued use and that the incidence of untoward effects is dose related. This product is inappropriate even in high doses for severe or
TYLOX (oxycodone and acetaminophen capsules) are given orally. The usual adult dosage is one TYLOX (oxycodone and acetaminophen capsules) capsule every 6 hours as needed for pain.
HOW SUPPLIED
TYLOX (oxycodone and acetaminophen capsules USP): (colored red, imprinted “TYLOX (oxycodone and acetaminophen capsules) ”
“McNEIL”)
NDC 0045-0526-60 - bottles of 100 and NDC-0045-0526-79 - unit dose
100's.
Dispense in tight, light-resistant container as defined in the official compendium.
Store at controlled room temperature (15°-30°C, 59°-86°F). Protect from moisture.
Manufactured by: Janssen Ortho, LLC Gurabo, Puerto Rico 00778.
Distributed by: OMP Division
Side Effects for Tylox
The most frequently observed adverse reactions include
Other adverse reactions include allergic reactions,
Drug Abuse And Dependence
TYLOX (oxycodone and acetaminophen capsules) capsules are a Schedule II controlled substance.
Oxycodone can produce drug dependence and has the potential for being abused.
(See
Drug Interactions for Tylox
Patients receiving other
The concurrent use of anticholinergics with narcotics may produce
Warnings for Tylox
Contains sodium metabisulfite, a sulfite that may cause allergic-type reactions including anaphylactic symptoms and life-threatening or less severe asthmatic episodes in certain susceptible people. The overall
Drug Dependence
Oxycodone can produce drug dependence of the morphine type and, therefore, has the potential for being abused. Psychic dependence, physical dependence and tolerance may develop upon repeated administration of TYLOX (oxycodone and acetaminophen capsules) (oxycodone and acetaminophen capsules), and it should be prescribed and administered with the same degree of caution appropriate to the use of other oral narcotic-containing medications. Like other narcotic-containing medications, TYLOX (oxycodone and acetaminophen capsules) is subject to the Federal Control Substances Act (Schedule II).
Precautions for Tylox
General
Head Injury and Increased Intracranial Pressure: The respiratory depressant effects of narcotics and their capacity to elevate cerebrospinal fluid pressure may be markedly exaggerated in the presence of head injury, other intracranial lesions or a pre-existing increase in intracranial pressure. Furthermore, narcotics produce adverse reactions which may obscure the clinical course of patients with head injuries.
Acute Abdominal Conditions: The administration of TYLOX (oxycodone and acetaminophen capsules) (oxycodone and acetaminophen capsules) or other narcotics may obscure the diagnosis or clinical course in patients with acute abdominal conditions.
Special Risk Patients: TYLOX (oxycodone and acetaminophen capsules) should be given with caution to
certain patients such as the elderly or debilitated, and those with severe impairment
of hepatic or renal function,
Usage in Pregnancy
Pregnancy Category C. Animal reproductive studies have not been conducted with TYLOX (oxycodone and acetaminophen capsules) . It is also not known whether TYLOX (oxycodone and acetaminophen capsules) can cause fetal harm when administered to a pregnant woman or can affect reproductive capacity. TYLOX (oxycodone and acetaminophen capsules) should not be given to a pregnant woman unless in the judgment of the physician, the potential benefits outweigh the possible hazards.
Nonteratogenic Effects: Use of narcotics during pregnancy may
produce physical dependence in the
Labor and Delivery
As with all narcotics, administration of TYLOX (oxycodone and acetaminophen capsules) to the mother shortly before delivery may result in some degree of respiratory depression in the newborn and the mother, especially if higher doses are used.
Nursing Mothers
It is not known whether the components of TYLOX (oxycodone and acetaminophen capsules) are excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when TYLOX (oxycodone and acetaminophen capsules) is administered to a nursing woman.
Pediatric Use
Safety and effectiveness in children have not been established.
Overdose Information for Tylox
Acetaminophen
Signs and Symptoms: In acute acetaminophen overdosage, dose-dependent
potentially fatal hepatic
In adults, hepatic toxicity has rarely been reported with acute overdoses of less than 10 grams and fatalities with less than 15 grams. Importantly, young children seem to be more resistant than adults to the hepatotoxic effect of an acetaminophen overdose. Despite this, the measures outlined below should be initiated in any adult or child suspected of having ingested an acetaminophen overdose.
Early symptoms following a potentially hepatotoxic overdose may include: nausea, vomiting, diaphoresis and general
Treatment: The stomach should be emptied promptly by lavage or
by induction of
The
Oxycodone
Signs and Symptoms: Serious overdosage with oxycodone is characterized
by respiratory depression (a decrease in
Treatment: Primary attention should be given to the reestablishment
of adequate respiratory exchange through provision of a
An antagonist should not be administered in the absence of clinically significant respiratory or
Contraindications for Tylox
TYLOX (oxycodone and acetaminophen capsules) should not be administered to patients who are hypersensitive to any component.
Clinical Pharmacology for Tylox
The principal ingredient, oxycodone, is a semisynthetic narcotic
Oxycodone is similar to codeine and
Acetaminophen is a non-
From
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