Faroxy ( Oxycodone )

Oxycodone HCL immediate release tablet

Introduction

Faroxy® tablets- manufactured by faran shimi pharmaceutical company -contain oxycodone hydrochloride. Oxycodone belongs to a group of medicines called opioid analgesics. Faroxy® is supplied in 5 mg, 15 mg, 30 mg tablets for oral administration. 10 tablets are packed in a blister and 3 blisters are packaged in one box with a leaflet.

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.These effects are mediated by receptors (notably μ) in the central nervous system, Oxycodone binds to the μ-opioid receptor and activates the μ-opioid receptor, whereas it does not bind to the κ-opioid receptor and does not activate the κ-opioid receptor. Importantly, in human beings, oxycodone behaves as a μ-opioid receptor agonist producing analgesia, Oxycodone does not cause psychotomimetic effects, dysphoria, diuresis, or other effects typical for a κ-opioid agonist.

Patient Information for Oxycodone ( Faroxy )

Indications

Faroxy® tablets are an immediate-release oral formulation of oxycodone hydrochloride indicated for the management of moderate to severe pain (acute pain) where the use of an opioid analgesic is appropriate.
Faroxy® appears to offer safe and effective postoperative analgesia, and is a well-accepted and reasonable alternative to standard intravenous opioid analgesics.

Important Information

Dosing

*All doses should be titrated to appropriate effect.

Dosing:Adult
Initial: 5 to 15 mg every 4 to 6 hours as needed .
Dosing range: 5 to 30 mg per dose every 4 to 6 hours.

Dosing:Renal Impairment:
CrCl ≥60 mL/minute: do not need to be adjusted.
CrCl <60 mL/minute: doses of 33% to 50% of usual initial dosing have been recommended.

Dosing: Hepatic Impairment:
Initiate therapy at 33% to 50% the usual dosage and titrate carefully.

Dosing:Pediatric Initial:
Infants ≤ 6 months 0.025 to 0.05 mg/kg/dose every 4 to 6 hours as needed.
Infants > 6 months, Children:
Patient weight <50 kg: Initial dose: 0.1 to 0.2 mg/kg/dose every 4 to 6 hours as needed.maximum dose range:5 to 10 mg/ dose.
Patient weight ≥50 kg: Initial dose: 5 to 10 mg every 4 to 6 hours as needed.
maximum dose range: 20 mg/ dose.

Dosing:Renal Impairment: GFR ≥50 mL/minute/1.73 m2: No dosage adjustment required
GFR 10 to 50 mL/minute/1.73 m2: Administer 75% of dose
GFR <10 mL/minute/1.73 m2: Administer 50% of dose
Hemodialysis: Administer 50% of dose posthemodialysis
Peritoneal dialysis: Administer 50% of dose

Dosing: Hepatic Impairment: Initiate therapy at 33% to 50% the usual dosage and titrate carefully.

Administration

Patients should have their dosage given on an aroundthe-clock basis to prevent the reoccurrence of pain rather than treating the pain after it has occurred.

After 3 to 7 days, determine 24-hour dose requirement and convert to Faroxy® extended release tablets manufactured by faran shimi pharmaceutical company.

Administer with or without food. Do not crush, chew, or dissolve the tablets.

Major Interactions(Risk X)

Azelastine (Nasal), Bromperidol, Conivaptan, Eluxadoline, Fusidic Acid (Systemic), Idelalisib, Opioids (mixed agonist/ antagonist), Orphenadrine, Oxomemazine, Paraldehyde, Thalidomide.

Pregnancy

Faroxy® is not commonly used to treat pain during labor and immediately postpartum (ACOG 209 2019) or chronic noncancer pain in pregnant women or those who may become pregnant.

Breast-Feeding

Faroxy® is present in breast milk. breastfeeding is not recommended during treatment with Faroxy®.

Contraindications & Cautions

Contraindications

Patients who are hypersensitive (eg, anaphylaxis, angioedema) to oxycodone or any component of the formulation.

Patients with circulatory shock and coma.

Signicant respiratory depression, acute or severe bronchial asthma

Known or suspected paralytic ileus and gastrointestinal obstruction

Warnings/Precautions

Concerns related to adverse effects:

CNS depression: May cause CNS depression, that may impair physical or mental abilities.

Constipation: May cause constipation, which may be problematic in patients with unstable angina and patients post-myocardial infarction (MI). Consider preventive measures (eg, stool softener, increased fiber) to reduce the potential for constipation.

Hypotension: May cause severe hypotension (including orthostatic hypotension and syncope); use with caution in patients with hypovolemia, cardiovascular disease (including acute MI), or drugs that may exaggerate hypotensive effects (including phenothiazines or general anesthetics).

Phenanthrene hypersensitivity: Use with caution in patients with hypersensitivity reactions to other phenanthrene-derivative opioid agonists (codeine,hydrocodone,hydromorphone,levorphanol,oxymorphone).

Respiratory depression : Serious, life-threatening, or fatal respiratory depression may occur. Monitor closely for respiratory depression, especially during initiation or dose escalation.

Concurrent drug therapy issues:

CYP 3A4 interactions: Use with all CYP3A4 inhibitors may result in an increase in oxycodone plasma concentrations, which could increase or prolong adverse drug effects and may cause potentially fatal respiratory depression.

Benzodiazepines or other CNS depressants: concomitant use of opioids with benzodiazepines or other CNS depressants, including alcohol, may result in profound sedation, respiratory depression, coma, and death.

Special populations:

Cachectic or debilitated patients: Use with caution in cachectic or debilitated patients; there is a greater potential for critical respiratory depression, even at therapeutic dosages.

Elderly: Use with caution in the elderly; Consider the use of alternative nonopioid analgesics in these patients.

Neonates: Neonatal withdrawal syndrome: Prolonged use of opioids during pregnancy can cause neonatal withdrawal syndrome, which may be life-threatening if not recognized and treated according to protocols developed by neonatology experts. If opioid use is required for a prolonged period in a pregnant woman, advise the patient of the risk of neonatal opioid withdrawal syndrome and ensure that appropriate treatment will be available. Signs and symptoms include irritability, hyperactivity and abnormal sleep pattern, high pitched cry, tremor, vomiting, diarrhea, and failure to gain weight. Onset, duration and severity depend on the drug used, duration of use, maternal dose, and rate of drug elimination by the newborn.

Abuse/misuse/diversion: Use exposes patients and other users to the risks of addiction, abuse, and misuse, potentially leading to overdose and death. Assess each patient's risk prior to prescribing; monitor all patients regularly for development of these behaviors or conditions.

Side Effects

Central nervous system: Drowsiness, headache, dizziness
Dermatologic: Pruritus
Gastrointestinal: Nausea, constipation, vomiting
Miscellaneous: Fever