Individual generic drug information

tapentadol

Reference monograph

Part of registered formulation

TAPENTADOL

Reference record: Tapentadol
Source: BNF 80 (2020–2021)
Printed source pages: 513
Age groups indexed: 1

Individual active ingredientSource records are displayed separately

Some source sections could not be separated reliably in the extraction. Review the printed source pages when a field is missing or incomplete.

Overview

Extracted information for Tapentadol only.

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

Source page 513

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.

Source page 513

Safety

Extracted information for Tapentadol only.

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.

Source page 513

Interactions

→Appendix 1: opioids

Source page 513

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

Source page 513

Breast Feeding

Avoid—no information available.

Source page 513

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.

Source page 513

Renal Impairment

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

Source page 513

Dose and formulations

Extracted information for Tapentadol only.

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

Source page 513

Dose text by age group

Filter the extracted dose blocks for this individual drug.

Adults

First line only; read the complete Indications and dose section above.

Initially 50 mg every 4–6 hours, adjusted

This is a first-line fragment. Read the full Indications and Dose section above.

Candidate age grouping · source page 513

Adults

First line only; read the complete Indications and dose section above.

Initially 50 mg every 12 hours, adjusted

This is a first-line fragment. Read the full Indications and Dose section above.

Candidate age grouping · source page 513

Age labels are extracted from the printed dose headings and require clinical review. Confirm current local guidance, dose, route, formulation, contraindications and interactions before prescribing.

Individual generic drug information

tapentadol

Reference monograph

Part of registered formulation

TAPENTADOL

Reference record: Tapentadol
Source: BNF 80 (2020–2021)
Printed source pages: 513
Age groups indexed: 1

Individual active ingredientSource records are displayed separately

Some source sections could not be separated reliably in the extraction. Review the printed source pages when a field is missing or incomplete.

Overview

Extracted information for Tapentadol only.

Indications And Dose

Source page 513

National Funding Access Decisions

Source page 513

Safety

Extracted information for Tapentadol only.

Important Safety Information

Source page 513

Interactions

→Appendix 1: opioids

Source page 513

Side Effects

Source page 513

Breast Feeding

Avoid—no information available.

Source page 513

Hepatic Impairment

Source page 513

Renal Impairment

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

Source page 513

Dose and formulations

Extracted information for Tapentadol only.

Medicinal Forms

Source page 513

Dose text by age group

Filter the extracted dose blocks for this individual drug.

Adults

First line only; read the complete Indications and dose section above.

Initially 50 mg every 4–6 hours, adjusted

This is a first-line fragment. Read the full Indications and Dose section above.

Candidate age grouping · source page 513

Adults

First line only; read the complete Indications and dose section above.

Initially 50 mg every 12 hours, adjusted

This is a first-line fragment. Read the full Indications and Dose section above.

Candidate age grouping · source page 513

Age labels are extracted from the printed dose headings and require clinical review. Confirm current local guidance, dose, route, formulation, contraindications and interactions before prescribing.