Company: Grunenthal Pharma Ltd.
Legal category: Controlled drug. GMS. Sport permitted.
Active ingredient: Tapentadol (hydrochloride) 20mg/ml.
Description: Oral solution.
Presentation: 200ml, €42.00.
Indications: Relief of moderate to severe acute pain in adults, which can be adequately managed only with opioid analgesics.
Pharmacology: Tapentadol is a strong analgesic with µ-agonistic opioid and additional noradrenaline reuptake inhibition properties.
Dosage: Adult: Initially, 50mg every 4-6 hours, with additional 50mg 1 hour after first dose if necessary on day 1. Maximum dose: 700mg daily (day 1), 600mg daily (maintenance). Consider switching to prolonged-release preparation if long-term treatment is anticipated and effective pain relief without intolerable adverse events achieved. Moderate hepatic impairment: Initially 25mg at 8 hour intervals minimum; doses >150mg at initiation are not recommended. Elderly: As per adults. Children: Under 18 years, not recommended.
Contraindications: Hypersensitivity to the active ingredient or to any of the excipients. Significant respiratory depression (in unmonitored settings or the absence of resuscitative equipment), acute or severe bronchial asthma or hypercapnia. Confirmed or suspected paralytic ileus. Acute intoxication with alcohol, hypnotics, centrally acting analgesics, or psychotropic active substances. During and immediately before labour and delivery. Lactation.
Special precautions: Monitor for signs of addiction and abuse. Not recommended: Severe renal/hepatic impairment, patients susceptible to intracranial effects of CO2 retention (e.g. evidence of increased intracranial pressure, impaired consciousness, coma). Caution: Impaired respiratory functions (use at lowest effective dose; consider alternative non-mu-opioid receptor agonist analgesics), head injury, brain tumours, history of a seizure disorder or risk of seizures, moderate hepatic impairment, biliary tract disease (including acute pancreatitis). Withdraw gradually. Driving/using machines. Pregnancy (assess risk/benefit).
Drug interactions: Avoid: MAOIs (within last 14 days). Caution: Benzodiazepines, barbiturates, opioids, CNS depressants, SSRIs, mixed mu-opioid agonist/antagonists (e.g. pentazocine, nalbuphine) or partial mu-opioid agonists (e.g. buprenorphine), strong UGT1A6, UGT1A9 and UGT2B7 inhibitors, strong enzyme inducing drugs (e.g. rifampicin, phenobarbital, St John’s Wort).
Adverse drug reactions: Decreased appetite, anxiety, confused state, hallucination, sleep disorder, abnormal dreams, dizziness, somnolence, headache, tremor, flushing, GI disorders, pruritus, hyperhidrosis, rash, muscle spasms, fatigue, feeling of body temperature change.
Full prescribing information and references available from Grunenthal Pharma Ltd. Telephone: (01) 468 8950. Fax: (01) 466 0793. Email: GeneralenquiresIE@grunenthal.com