Adempas Tablets and Tramadol Hydrochloride

• Generic Name: riociguat
• Dosage Forms: tablet, film coated
• Other Brand Names: Adempas

Riociguat is used to treat chronic thromboembolic pulmonary hypertension (CTEPH) in people who cannot be treated with surgery, or in people who have undergone surgery but still have symptoms. Riociguat can treat certain symptoms of CTEPH and can improve your ability to exercise.

Riociguat is also used to treat pulmonary arterial hypertension (PAH). Riociguat can improve your ability to exercise and help prevent PAH from getting worse.

Riociguat is available to women only under a special program. You must be registered in the program and understand the risks and benefits of riociguat.

Riociguat may also be used for purposes not listed in this medication guide.

• Generic Name: tramadol
• Dosage Forms: n.a.
• Other Brand Names: ConZip, Ultram, Ultram ER, Rybix ODT, Ryzolt

Conventional tablets: Management of pain that is severe enough to require an opiate analgesic and for which alternative treatment options (e.g., nonopiate analgesics) have not been, or are not expected to be, adequate or tolerated. Efficacy established in patients with moderately severe acute or chronic pain, including postoperative, gynecologic, obstetric, and cancer pain.

Extended-release tablets or capsules: Management 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. Efficacy established in 2 studies in patients with moderate to moderately severe chronic pain associated with osteoarthritis; several other studies failed to provide adequate evidence of efficacy.

Tramadol/acetaminophen tablets: Short-term (≤5 days) management of acute pain that is severe enough to require an opiate analgesic and for which alternative treatment options (e.g., nonopiate analgesics) have not been, or are not expected to be, adequate or tolerated.

American College of Rheumatology (ACR) states tramadol can be considered in patients with osteoarthritis in whom NSAIAs are contraindicated (e.g., those with renal impairment) or in whom acetaminophen or NSAIAs have not produced an adequate response.

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.)

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.)