AndroGel Pump 1.25 g/actuation and Oxycodone Hydrochloride

• Generic Name: testosterone
• Dosage Forms: gel
• Other Brand Names: Androderm, Androgel, Axiron, FIRST-Testosterone, Fortesta, Testim, Vogelxo, AndroGel Packets, AndroGel Pump 125 g/actuation, Aveed, Delatestryl, Depo-Testosterone, Testosterone Cypionate, Testosterone Enanthate, Testosterone undecanoate, Xyosted, Natesto, Striant

Testosterone is a naturally occurring male hormone necessary for many processes in the body.

AndroGel Pump 1.25 g/actuation (for the skin) is used to treat conditions in men that result from a lack of natural testosterone.

Testosterone will not enhance athletic performance and should not be used for that purpose.

AndroGel Pump 1.25 g/actuation may also be used for purposes not listed in this medication guide.

• Generic Name: oxycodone
• Dosage Forms: n.a.
• Other Brand Names: Oxaydo, Oxycontin, Oxyfast, Roxicodone, Roxybond, Xtampza ER; oxycodone is also present in the following combination drugs: Combunox, Endocet, Endodan, Moxduo, Oxycodan, Percocet, Percodan, Primlev, Roxicet, Xartemis XR, and others, Oxycontin, Xtampza ER, Oxecta, OxyIR, Roxybond

Relief of moderate to severe pain when use of an opiate analgesic is appropriate and alternative treatments are inadequate.

Usually, temporary relief of moderate to moderately severe pain such as that associated with acute and some chronic medical disorders including renal or biliary colic, acute trauma, postoperative pain, and cancer.

Opiates given orally in combination with acetaminophen or NSAIAs may produce greater analgesic effect than either drug alone; may also cause fewer adverse effects than equianalgesic doses of the individual drugs alone.

Extended-release oxycodone hydrochloride/acetaminophen in fixed combination: Relief of acute pain that is severe enough to require opiate therapy and for which alternative treatments (e.g., nonopiate analgesics) are inadequate or not tolerated.

In symptomatic treatment of acute pain, reserve opiate analgesics for pain resulting from severe injuries, severe medical conditions, or surgical procedures, or when nonopiate alternatives for relieving pain and restoring function are expected to be ineffective or are contraindicated. Use smallest effective dosage for shortest possible duration since long-term opiate use often begins with treatment of acute pain. Optimize concomitant use of other appropriate therapies. (See Managing Opiate Therapy for Acute Pain under Dosage and Administration.)

Reserve oxycodone hydrochloride extended-release tablets and oxycodone myristate extended-release capsules for relief of pain that is severe enough to require long-term, daily, around-the-clock use of an opiate analgesic and for which alternative treatment options (e.g., nonopiate analgesics or immediate-release opiates) are inadequate or not tolerated; not indicated for as-needed (“prn”) use.

For relief of moderate to severe malignant (cancer) pain and chronic nonmalignant pain when use of an opiate analgesic is appropriate and alternative treatments are inadequate.

Oxycodone hydrochloride extended-release tablets and oxycodone myristate extended-release capsules: Use only for relief of pain that is severe enough to require long-term, daily, around-the-clock use of an opiate analgesic and for which alternative treatment options (e.g., nonopiate analgesics, immediate-release opiates) are inadequate or not tolerated. Not indicated for as-needed (“prn”) use.

In the management of chronic pain associated with a terminal illness such as cancer, the principal goal of analgesic therapy is to make the patient relatively pain-free while maintaining as good a quality of life as possible.

Although consideration of the dependence potential of opiate agonists has often limited their effective use by many clinicians in terminally ill patients with severe, chronic pain, such consideration is irrelevant in the context of terminal illness.

Generally use opiates for management of chronic pain (i.e., pain lasting >3 months or past the time of normal tissue healing ) that is not associated with active cancer treatment, palliative care, or end-of-life care only if other appropriate nonpharmacologic and nonopiate pharmacologic strategies have been ineffective and expected benefits for both pain relief and functional improvement are anticipated to outweigh risks.

If used for chronic pain, opiate analgesics should be part of an integrated approach that also includes appropriate nonpharmacologic modalities (e.g., cognitive-behavioral therapy, relaxation techniques, biofeedback, functional restoration, exercise therapy, certain interventional procedures) and other appropriate pharmacologic therapies (e.g., nonopiate analgesics, analgesic adjuncts such as selected anticonvulsants and antidepressants for certain neuropathic pain conditions).

Available evidence insufficient to determine whether long-term opiate therapy for chronic pain results in sustained pain relief or improvements in function and quality of life or is superior to other pharmacologic or nonpharmacologic treatments. Use is associated with serious risks (e.g., opiate use disorder, overdose). (See Managing Opiate Therapy for Chronic Noncancer Pain under Dosage and Administration.)