Drug reference

Tapentadol

BNF 80 (2020–2021)

Source: BNF 80 (2020–2021)
PDF pages: 513

Review source pages for extracted sections and age labels. BNF dose snippets show only their first line.

Overview

Indications And Dose

Moderate to severe acute pain which can be managed only with opioid analgesics ▶BY MOUTH USING IMMEDIATE-RELEASE MEDICINES ▶Adult: Initially 50 mg every 4–6 hours, adjusted according to response, on the ﬁrst day of treatment, an additional dose of 50 mg may be taken 1 hour after the initial dose; maximum 700 mg in the ﬁrst 24 hours; maximum 600 mg per day Severe chronic pain ▶BY MOUTH USING MODIFIED-RELEASE MEDICINES ▶Adult: Initially 50 mg every 12 hours, adjusted according to response; maximum 500 mg per day

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National Funding Access Decisions

Scottish Medicines Consortium (SMC) decisions SMC No. 654/10 The Scottish Medicines Consortium has advised (June 2011) that tapentadol (Palexia ® SR) is accepted for restricted use within NHS Scotland for the management of severe chronic pain in adult patients, which can be adequately managed only with opioid analgesics, when morphine sulfate modiﬁed-release has failed to provide adequate pain control or is not tolerated.

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Safety

Important Safety Information

MHRA/CHM ADVICE: TAPENTADOL (PALEXIA ®): RISK OF SEIZURES AND REPORTS OF SEROTONIN SYNDROME WHEN CO- ADMINISTERED WITH OTHER MEDICINES (JANUARY 2019) Tapentadol can induce seizures and should be prescribed with caution in patients with a history of seizure disorders or epilepsy. Seizure risk may be increased in patients taking other medicines that lower seizure threshold, for example, antidepressants such as selective serotonin reuptake inhibitors (SSRIs), serotonin- noradrenaline reuptake inhibitors (SNRIs), tricyclic antidepressants, and antipsychotics. Serotonin syndrome has been reported when tapentadol is used in combination with serotonergic antidepressants—withdrawal of the serotonergic medicine, together with supportive symptomatic care, usually brings about a rapid improvement in serotonin syndrome.

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Interactions

→Appendix 1: opioids

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Side Effects

▶Common or very common Anxiety. appetite decreased. asthenia. diarrhoea. feeling of body temperature change. gastrointestinal discomfort. muscle spasms. sleep disorders. tremor ▶Uncommon Concentration impaired. depressed mood. dysarthria. dyspnoea. feeling abnormal. irritability. memory loss. movement disorders. muscle contractions involuntary. oedema. sensation abnormal. urinary disorders ▶Rare or very rare Angioedema. impaired gastric emptying. level of consciousness decreased. seizure. thinking abnormal

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Breast Feeding

Avoid—no information available.

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Hepatic Impairment

Manufacturer advises caution in moderate impairment; avoid in severe impairment (no information available). Dose adjustments Manufacturer advises reduce initial daily dose in moderate impairment. For immediate-release tablets, initiate at 50 mg up to every 8 hours; for oral Nervous system solution, initiate at 25 mg up to every 8 hours; for modiﬁed- release tablets, initiate at 50 mg up to every 24 hours.

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Renal Impairment

Manufacturer advises avoid in severe impairment (no information available).

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Dose and formulations

Medicinal Forms

There can be variation in the licensing of different medicines containing the same drug. Oral solution CAUTIONARY AND ADVISORY LABELS 2 EXCIPIENTS: May contain Propylene glycol ▶Palexia (Grunenthal Ltd) Tapentadol (as Tapentadol hydrochloride) 20 mg per 1 ml Palexia 20mg/ml oral solution sugar-free | 100 ml P £17.80 DT = £17.80 b Modified-release tablet CAUTIONARY AND ADVISORY LABELS 2, 25 ▶Palexia SR (Grunenthal Ltd) Tapentadol (as Tapentadol hydrochloride) 50 mg Palexia SR 50mg tablets | 28 tablet P £12.46 DT = £12.46 b | 56 tablet P £24.91 b Tapentadol (as Tapentadol hydrochloride) 100 mg Palexia SR 100mg tablets | 56 tablet P £49.82 DT = £49.82 b Tapentadol (as Tapentadol hydrochloride) 150 mg Palexia SR 150mg tablets | 56 tablet P £74.73 DT = £74.73 b Tapentadol (as Tapentadol hydrochloride) 200 mg Palexia SR 200mg tablets | 56 tablet P £99.64 DT = £99.64 b Tapentadol (as Tapentadol hydrochloride) 250 mg Palexia SR 250mg tablets | 56 tablet P £124.55 DT = £124.55 b Tablet CAUTIONARY AND ADVISORY LABELS 2 ▶Palexia (Grunenthal Ltd) Tapentadol (as Tapentadol hydrochloride) 50 mg Palexia 50mg tablets | 28 tablet P £12.46 DT = £12.46 b | 56 tablet P £24.91 b Tapentadol (as Tapentadol hydrochloride) 75 mg Palexia 75mg tablets | 28 tablet P £18.68 DT = £18.68 b | 56 tablet P £37.37 b eiiii F 467

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Dose text by age group

Adult

Initially 50 mg every 4–6 hours, adjusted

First-line fragment. Read the complete Indications and Dose section above.

PDF page 513

Adult

Initially 50 mg every 12 hours, adjusted

First-line fragment. Read the complete Indications and Dose section above.

PDF page 513

Age labels are extracted for navigation. Check the complete source section and current local guidance before clinical use.

Drug reference

Tapentadol

BNF 80 (2020–2021)

Source: BNF 80 (2020–2021)
PDF pages: 513

Review source pages for extracted sections and age labels. BNF dose snippets show only their first line.

Overview

Indications And Dose

PDF page 513

National Funding Access Decisions

PDF page 513

Safety

Important Safety Information

PDF page 513

Interactions

→Appendix 1: opioids

PDF page 513

Side Effects

PDF page 513

Breast Feeding

Avoid—no information available.

PDF page 513

Hepatic Impairment

PDF page 513

Renal Impairment

Manufacturer advises avoid in severe impairment (no information available).

PDF page 513

Dose and formulations

Medicinal Forms

PDF page 513

Dose text by age group

Adult

Initially 50 mg every 4–6 hours, adjusted

First-line fragment. Read the complete Indications and Dose section above.

PDF page 513

Adult

Initially 50 mg every 12 hours, adjusted

First-line fragment. Read the complete Indications and Dose section above.

PDF page 513

Age labels are extracted for navigation. Check the complete source section and current local guidance before clinical use.