OXYCODONE AND ASPIRIN tablet

Država: Sjedinjene Američke Države

Jezik: engleski

Izvor: NLM (National Library of Medicine)

Aktivni sastojci:

OXYCODONE HYDROCHLORIDE (UNII: C1ENJ2TE6C) (OXYCODONE - UNII:CD35PMG570), OXYCODONE TEREPHTHALATE (UNII: M04XWV43UF) (OXYCODONE - UNII:CD35PMG570), ASPIRIN (UNII: R16CO5Y76E) (ASPIRIN - UNII:R16CO5Y76E)

Dostupno od:

Physicians Total Care, Inc.

INN (International ime):

OXYCODONE HYDROCHLORIDE

Sastav:

OXYCODONE HYDROCHLORIDE 4.5 mg

Administracija rute:

ORAL

Tip recepta:

PRESCRIPTION DRUG

Terapijske indikacije:

Oxycodone and aspirin tablets are indicated for the management of moderate to moderately severe pain. Oxycodone and aspirin tablets are contraindicated in patients with known hypersensitivity to oxycodone or aspirin, and in any situation where opioids or aspirin are contraindicated. Aspirin is contraindicated for patients with hemophilia. Reye’s Syndrome: Aspirin should not be used in children or teenagers for viral infections, with or without fever, because of the risk of Reye’s syndrome with concomitant use of aspirin in certain viral illnesses. Allergy: Aspirin is contraindicated in patients with known allergy to nonsteroidal anti-inflammatory drug products and in patients with the syndrome of asthma, rhinitis, and nasal polyps. Aspirin may cause severe urticaria, angioedema, or bronchospasm (asthma). Oxycodone is contraindicated in patients with known hypersensitivity to oxycodone. Oxycodone is contraindicated in any situation where opioids are contraindicated including patients with significa

Proizvod sažetak:

Oxycodone and Aspirin Tablets USP are yellow, round biconvex tablets, debossed with WATSON and 820 on one side, and plain and scored on the other side, supplied in Store at controlled room temperature 15°-30°C (59°-86°F). [See USP.] REPLACE CAP IMMEDIATELY. PROTECT FROM LIGHT AND MOISTURE. Dispense in a tight, light-resistant container as defined in the USP. DEA Order Form Required. Watson Laboratories, Inc. Corona, CA 92880 USA Relabeling and Repackaging by: Physicians Total Care, Inc. Tulsa, OK       74146

Status autorizacije:

Abbreviated New Drug Application

Svojstava lijeka

OXYCODONE AND ASPIRIN - OXYCODONE AND ASPIRIN TABLET
PHYSICIANS TOTAL CARE, INC.
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DESCRIPTION
Oxycodone and Aspirin Tablets, for oral administration, contain:
Oxycodone Hydrochloride USP 4.5 mg*
Oxycodone Terephthalate USP 0.38 mg*
Aspirin USP 325 mg
* The total of 4.5 mg oxycodone HCl and 0.38 mg oxycodone
terephthalate is equivalent to 4.33 mg of
oxycodone as the free base.
In addition, each tablet also contains 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. Oxycodone Terephthalate is
freely soluble in water and slightly
soluble in alcohol. Oxycodone hydrochloride is represented by the
following structural formula:
Molecular formula: C
H NO •HCl
Molecular weight: 351.82
The aspirin component is 2-(acetyloxy)-, Benzoic acid, a white
crystal, commonly tabular or needlelike,
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:
Molecular formula: C H O
Molecular weight: 180.16
CLINICAL PHARMACOLOGY
CENTRAL NERVOUS SYSTEM
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.
18
21
4
9
8
4
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