Faroxyphen
Introduction
Faroxyphen® is a combination of the oxycodone with acetaminophen, used to relieve moderate to severe pain.Faroxyphen ® _manufactured by Faran Shimi Pharmaceutical Company_ is available in 325mg/5mg and 325mg/10mg tablets
10 tablets are packed in a blister and 3 blisters are packaged in one box with a leaflet.
Indications
Relief of moderate to severe pain severe enough to require an opioid analgesic and
for which alternative treatments are inadequate.
Important Information
Dosing
Initial dose is based on the oxycodone content; however, the maximum daily dose is based on the acetaminophen content.
Adults
Doses should be titrated to appropriate analgesic effects.
Initial dose, based on oxycodone content: 5mg (moderate pain) or 10 to 20mg (severe pain).
Doses typically given every 4 to 6 hours as needed. Do not exceed acetaminophen 4g/day.
Renal Impairment: (Adult)
No dosage adjustment necessary; Use with caution and initiate at the low end of the dosing range; titrate carefully and monitor closely.
Hepatic Impairment: (Adult)
No dosage adjustment necessary; Use with caution and initiate at the low end of the dosing range; titrate carefully and monitor closely.
Pediatrics:
Analgesic, moderate: 0.1 to 0.2mg/kg/dose; doses typically given every 4 to 6 hours as needed; maximum initial oxycodone dose: 5mg/dose.
Analgesic, severe: 0.2mg/kg/dose; doses typically given every 4 to 6 hours as needed; maximum initial oxycodone dose: 10mg.
Titrate dose to appropriate analgesic effects; maximum daily acetaminophen dose: 75mg/kg/day not to exceed 4g/day; do not exceed 5 doses in 24 hours.
Geriatrics:
Use with caution and consider initiation at the low end of the dosing range; titrate slowly.
Administration:
May administer with food to decrease GI upset.
Major Interactions (Risk X)
Azelastine (Nasal), Bromperidol, Conivaptan, Eluxadoline, Fusidic Acid (Systemic), Idelalisib,
Opioids (Mixed Agonist/ Antagonist), Orphenadrine, Oxomemazine, Paraldehyde, Thalidomide .
Pregnancy
Prolonged use during pregnancy can result in neonatal opioid withdrawal syndrome,which may be life-threatening if not recognized and treated. 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.
Breast-Feeding
Acetaminophen and Oxycodone are present in breast milk.
Due to the potential for serious adverse reactions in the breastfed infant, breastfeeding is not recommended.
Contraindications
Hypersensitivity (e.g., anaphylaxis) to oxycodone, acetaminophen, or any component of the formulation;
significant respiratory depression; acute or severe bronchial asthma (in an unmonitored setting or in the
absence of resuscitative equipment); GI obstruction, including paralytic ileus.
Warnings/Precautions
• CNS depression: may impair physical or mental abilities; patients must be cautioned about
performing tasks which require mental alertness (e.g., operating machinery or driving).
• Constipation: Consider preventive measures (e.g., stool softener, increased fiber) to reduce the potential for constipation.
• Hepatotoxicity: Acetaminophen has been associated with cases of acute liver failure. Most of the cases of liver injury are associated with the use of
acetaminophen at dosages that exceed 4 g/day, and often involve more than one acetaminophen-containing product. Risk is increased with alcohol use,
preexisting liver disease, and intake of more than one source of acetaminophen-containing medications.
• Hypersensitivity reactions: Hypersensitivity and anaphylactic reactions have been reported. Discontinue therapy at the
first appearance of skin rash or any other sign of hypersensitivity.
• Hypotension (orthostatic hypotension and syncope): use with caution in patients with hypovolemia, cardiovascular disease (e.g., acute MI),
or drugs that may exaggerate hypotensive effects (phenothiazines or general anesthetics). Monitor for symptoms
of hypotension following initiation or dose titration.
• Respiratory depression: Monitor for respiratory depression, especially during initiation of therapy or following a dose increase.
• G6PD deficiency: Use with caution.
• Phenanthrene hypersensitivity: Use with caution in patients with hypersensitivity reactions to other Phenanthrene-derivative
opioid agonists (hydrocodone, hydromorphone, levorphanol, codeine, oxymorphone).
Side Effects
• Central nervous system: Dizziness, headache, drowsiness, fatigue, insomnia.
• Dermatologic: Pruritus, skin rash, erythema, skin blister.
• Endocrine & metabolic: Hot flash.
• Gastrointestinal: Nausea, constipation, vomiting, dyspepsia, xerostomia.
• Respiratory: Cough.
