OXYCODONE HYDROCHLORIDE capsule

Country: Amerika Syarikat

Bahasa: Inggeris

Sumber: NLM (National Library of Medicine)

Bahan aktif:

OXYCODONE HYDROCHLORIDE (UNII: C1ENJ2TE6C) (OXYCODONE - UNII:CD35PMG570)

Boleh didapati daripada:

Bryant Ranch Prepack

INN (Nama Antarabangsa):

OXYCODONE HYDROCHLORIDE

Komposisi:

OXYCODONE HYDROCHLORIDE 5 mg

Laluan pentadbiran:

ORAL

Jenis preskripsi:

PRESCRIPTION DRUG

Tanda-tanda terapeutik:

Oxycodone hydrochloride capsule is an opioid analgesic, indicated for the management of moderate to severe acute and chronic pain where use of an opioid analgesic is appropriate. Oxycodone hydrochloride is contraindicated in patients with respiratory depression in the absence of resuscitative equipment. Oxycodone hydrochloride is contraindicated in any patient who has or is suspected of having paralytic ileus. Oxycodone hydrochloride is contraindicated in patients with acute or severe bronchial asthma or hypercarbia. Oxycodone hydrochloride is contraindicated in patients with known hypersensitivity to oxycodone, oxycodone salts, or any components of the product. Pregnancy Category B: There are no adequate and well-controlled studies of oxycodone use during pregnancy. Based on limited human data in the literature, oxycodone does not appear to increase the risk of congenital malformations. Because animal reproduction studies are not always predictive of human response, oxycodone should be used during pregnancy

Ringkasan produk:

Oxycodone Hydrochloride Capsule Oxycodone Hydrochloride Capsule 5 mg is a hard gelatin capsule with an opaque yellow cap imprinted in black ink with "LV" and an opaque white body imprinted in black ink with "901" available in one strength as follows: 5 mg capsule NDC# 68462-204-01: Bottle of 100 Capsules Storage Store at Controlled Room Temperature, 25°C (77°F); excursions are permitted to 15° - 30°C (59° - 86°F). PROTECT from MOISTURE and LIGHT. Handling All opioids, including oxycodone hydrochloride, are liable to diversion and misuse both by the general public and healthcare workers and should be handled accordingly. DEA Order Form Required Dispense in a tight, light-resistant container. Protect from moisture.

Status kebenaran:

New Drug Application Authorized Generic

Ciri produk

OXYCODONE HYDROCHLORIDE- OXYCODONE HYDROCHLORIDE CAPSULE
BRYANT RANCH PREPACK
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
OXYCODONE HYDROCHLORIDE CAPSULES SAFELY
AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR OXYCODONE
HYDROCHLORIDE CAPSULES.
OXYCODONE HYDROCHLORIDE CAPSULES CII
INITIAL U.S. APPROVAL: 1950
INDICATIONS AND USAGE
Oxycodone hydrochloride is an opioid agonist indicated for the
management of moderate to severe acute and chronic pain
where the use of an opioid analgesic is appropriate. (1)
DOSAGE AND ADMINISTRATION
Oxycodone Hydrochloride Capsule, 5 mg: 5 mg to 15 mg every 4 to 6
hours as needed. (2.2).
DOSAGE FORMS AND STRENGTHS
Oxycodone hydrochloride capsules are available in one strength. Each
hard gelatin capsule contains 5 mg oxycodone
hydrochloride. (3)
CONTRAINDICATIONS
Respiratory depression in the absence of resuscitative equipment. (4)
Paralytic ileus. (4)
Acute or severe bronchial asthma or hypercarbia. (4)
Known hypersensitivity to oxycodone. (4)
WARNINGS AND PRECAUTIONS
Respiratory depression: Increased risk in elderly, debilitated
patients, those suffering from conditions accompanied by
hypoxia, hypercapnia, or upper airway obstruction. (5.1)
Misuse, Abuse and Diversion: Oxycodone hydrochloride is a Schedule II
controlled substance with an abuse liability
similar to other opioids. (5.2)
CNS effects: Additive CNS depressive effects when used in conjunction
with alcohol, other opioids, or illicit drugs. (5.3)
Elevation of intracranial pressure: May be markedly exaggerated in the
presence of head injury, other intracranial
lesions. (5.4)
Hypotensive effect: Increased risk with compromised ability to
maintain blood pressure. (5.5)
Prolonged gastric obstruction: In patients with gastrointestinal
obstruction, especially paralytic ileus. (5.6)
Sphincter of Oddi spasm and diminished biliary/pancreatic secretions.
Increased risk with biliary tract disease. (5.7)
Special Risk Groups: Use with caution and in reduced dosag