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 Φάρμακα Α - Ζ  Συγχορήγηση  Μητρότητα

OXYCODONE HYDROCHLORIDE Capsule (2020)

Αναφορές

Βιβλιογραφική αναφορά

Συγγραφείς

KVK-TECH, INC.

Λέξεις κλειδιά

10702-023

Για την προβολή της πλήρους καταχώρησης απαιτείται συνδρομή σε ισχύ.
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1. Indications and Usage

Oxycodone Hydrochloride Capsule is an opioid agonist indicated for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate. Limitations of ...

2. Dosage and Administration

2.1 Important Dosage and Administration Instructions Use the lowest effective dosage for the shortest duration consistent with individual patient treatment goals [see Warnings and Precautions (5)]. Initiate ...

3. Dosage Forms and Strengths

Oxycodone Hydrochloride Capsules, USP. <u>Capsules 5 mg:</u> Each capsule has a light brown opaque cap, peach opaque body with black imprint K 23 on both cap and body, filled with powder containing 5 mg ...

4. Contraindications

Oxycodone Hydrochloride Capsule is contraindicated in patients with: Significant respiratory depression <em>[see Warnings and Precautions (5.2)]</em> Acute or severe bronchial asthma in an unmonitored ...

5. Warnings and Precautions

5.1 Addiction, Abuse, and Misuse Oxycodone Hydrochloride Capsules contains oxycodone, a Schedule II controlled substance. As an opioid, Oxycodone Hydrochloride Capsules expose users to the risks of addiction, ...

6. Adverse Reactions

The following serious adverse reactions are described, or described in greater detail, in other sections: Addiction, Abuse, and Misuse <em>[see Warnings and Precautions (5.1)]</em> Life-Threatening Respiratory ...

7. Drug Interactions

Inhibitors of CYP3A4 and CYP2D6 <b>Clinical Impact</b> The concomitant use of Oxycodone Hydrochloride Capsules and CYP3A4 inhibitors can increase the plasma concentration of oxycodone, resulting in ...

8.1. Pregnancy

Risk Summary Prolonged use of opioid analgesics during pregnancy may cause neonatal opioid withdrawal syndrome <em>[see Warnings and Precautions (5.3)]</em>. Available data with Oxycodone Hydrochloride ...

8.2. Lactation

Risk Summary Oxycodone is present in breast milk. Published lactation studies report variable concentrations of oxycodone in breast milk with administration of immediate-release oxycodone to nursing mothers ...

8.3. Females and Males of Reproductive Potential

Infertility Chronic use of opioids may cause reduced fertility in females and males of reproductive potential. It is not known whether these effects on fertility are reversible <em>[see Adverse Reactions ...

8.4. Pediatric Use

The safety and effectiveness and the pharmacokinetics of Oxycodone Hydrochloride Capsules in pediatric patients below the age of 18 have not been established.

8.5. Geriatric Use

Elderly patients (aged 65 years or older) may have increased sensitivity to oxycodone. In general, use caution when selecting a dose for an elderly patient, usually starting at the low end of the dosing ...

9.1. Controlled Substance

Oxycodone Hydrochloride Capsules contains oxycodone, a Schedule II controlled substance.

9.2. Abuse

Oxycodone Hydrochloride Capsules contains oxycodone, a substance with a high potential for abuse similar to other opioids including fentanyl, hydrocodone, hydromorphone, methadone, morphine, oxymorphone, ...

9.3. Dependence

Both tolerance and physical dependence can develop during chronic opioid therapy. Tolerance is the need for increasing doses of opioids to maintain a defined effect such as analgesia (in the absence of ...

10. Overdosage

Clinical Presentation Acute overdose with Oxycodone Hydrochloride Capsules can be manifested by respiratory depression, somnolence progressing to stupor or coma, skeletal muscle flaccidity, cold and clammy ...

11. Description

Oxycodone Hydrochloride Capsule is an agonist, available as a hard gelatin capsule 5 mg for oral administration. The chemical name is (5R,9R,13S,14S)-4, 5α-epoxy-14-hydroxy-3-methoxy-17-methylmorphinan-6-one ...

12.1. Mechanism of Action

Oxycodone is a full opioid agonist and is relatively selective for the mu-opioid receptor, although it can bind to other opioid receptors at higher doses. The principal therapeutic action of oxycodone ...

12.2. Pharmacodynamics

Effects on the Central Nervous System (CNS) Oxycodone produces respiratory depression by direct action on brain stem respiratory centers. The respiratory depression involves a reduction in the responsiveness ...

12.3. Pharmacokinetics

The activity of oxycodone hydrochloride is primarily due to the parent drug oxycodone. Absorption About 60 to 87% of an oral dose reaches the systemic circulation in comparison to a parenteral dose. This ...

13.1. Carcinogenesis, Mutagenesis, Impairment of Fertility

Carcinogenesis Long-term studies in animals to evaluate the carcinogenic potential of oxycodone hydrochloride have not been conducted. Mutagenesis Oxycodone hydrochloride was genotoxic in an in vitro mouse ...

16.1. How Supplied

Oxycodone Hydrochloride Capsule 5 mg is a hard gelatin capsule with a light brown opaque cap, peach opaque body with black imprint K 23 on both cap and body, filled with powder, supplied as: NDC 10702-023-06: ...

16.2. Storage and Handling

Protect from moisture and light. Store at 25°C (77°F); excursions are permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature].

17. Patient Counseling Information

Advise the patient to read the FDA-approved patient labeling (Medication Guide). Addiction, Abuse, and Misuse Inform patients that the use of Oxycodone Hydrochloride Capsules, even when taken as recommended, ...

BOXED WARNING SECTION

<b>WARNING: ADDICTION, ABUSE, AND MISUSE; LIFE-THREATENING RESPIRATORY DEPRESSION; ACCIDENTAL INGESTION; NEONATAL OPIOID WITHDRAWAL SYNDROME; and CYTOCHROME P450 3A4 INTERACTION; and RISKS FROM CONCOMITANT ...