Individual generic drug information

ketoprofen

Reference monograph

Part of registered formulation

KETOPROFEN + CAPSICUM OLEORESIN

Reference record: Ketoprofen
Source: BNF 80 (2020–2021)
Printed source pages: 1229, 1230
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 Ketoprofen only.

Indications And Dose

Pain and mild inflammation in rheumatic disease and musculoskeletal conditions| Dysmenorrhoea | Acute gout ▶BY MOUTH ▶Adult: 100–200 mg once daily Relief of pain in rheumatic disease and musculoskeletal conditions ▶TO THE SKIN ▶Adult: Apply 2–4 times a day for up to 7 days, ketoprofen 2.5% gel to be administered; maximum 15 g per day POWERGEL ® Relief of pain in musculoskeletal conditions | Adjunctive treatment in knee or hand osteoarthritis ▶TO THE SKIN ▶Adult: Apply 2–3 times a day for up to max. 10 days

Source page 1229

Contra Indications

▶With systemic use Active gastro-intestinal bleeding. active gastro-intestinal ulceration. coagulation disorders. history of gastro-intestinal bleeding. history of gastro- intestinal perforation. history of gastro-intestinal ulceration. severe heart failure

Source page 1229

Cautions

▶With systemic use Allergic disorders. cardiac impairment (NSAIDs may impair renal function). cerebrovascular disease. connective-tissue disorders. dehydration (risk of renal impairment). elderly (risk of serious side-effects and fatalities). heart failure. history of gastro-intestinal disorders (e.g. ulcerative colitis, Crohn’s disease). ischaemic heart disease. peripheral arterial disease. risk factors for cardiovascular events. uncontrolled hypertension ▶With topical use Avoid contact with eyes. avoid contact with inﬂamed or broken skin. avoid contact with mucous membranes. not for use with occlusive dressings. topical application of large amounts can result in systemic effects, including hypersensitivity and asthma (renal disease has also been reported)

Source page 1229

Allergy And Cross Sensitivity

Contra-indicated in patients with a history of hypersensitivity to aspirin or any other NSAID—which includes those in whom attacks of asthma, angioedema, urticaria or rhinitis have been precipitated by aspirin or any other NSAID.

Source page 1230

Exceptions To Legal Category

▶With topical use Smaller pack sizes of gel preparations may be available on sale to the public.

Source page 1230

Safety

Extracted information for Ketoprofen only.

Interactions

→Appendix 1: NSAIDs

Source page 1229

Side Effects

GENERAL SIDE-EFFECTS ▶Uncommon Diarrhoea. paraesthesia. skin reactions ▶Rare or very rare Hypersensitivity. photosensitivity reaction. renal impairment ▶Frequency not known Angioedema SPECIFIC SIDE-EFFECTS ▶Common or very common ▶With oral use Gastrointestinal discomfort. nausea. vomiting ▶Uncommon ▶With oral use Constipation. dizziness. drowsiness. fatigue. gastrointestinal disorders. headache. oedema. rash (discontinue) ▶With topical use Increased risk of infection ▶Rare or very rare ▶With oral use Asthma. haemorrhagic anaemia. hepatic disorders. pancreatitis. shock. stomatitis. tinnitus. vision disorders. weight increased ▶Frequency not known ▶With oral use Acute kidney injury (more common in patients with pre-existing renal impairment). Musculoskeletal system agranulocytosis. alopecia. appetite decreased. bone marrow failure. bronchospasm. confusion. Crohn’s disease aggravated. depression. dyspnoea. fertility decreased female. haemorrhage. hallucination. hearing impairment. heart failure. hypertension. increased risk of arterial thromboembolism. increased risk of ischaemic stroke. increased risk of myocardial infarction. malaise. meningitis aseptic (patients with connective-tissue disorders such as systemic lupus erythematosus may be especially susceptible). menometrorrhagia. mood altered. nephritic syndrome. nephritis tubulointerstitial. nephrotic syndrome. neutropenia. optic neuritis. rhinitis . seizure. severe cutaneous adverse reactions (SCARs). taste altered. thrombocytopenia. vasodilation. vertigo ▶With topical use Eosinophilia. eyelid oedema. fever. gastrointestinal haemorrhage. lip swelling. peptic ulcer. vasculitis. wound complications SIDE-EFFECTS, FURTHER INFORMATION Topical application of large amounts can result in systemic effects, including hypersensitivity and asthma (renal disease has also been reported). For information about cardiovascular and gastrointestinal side-effects, and a possible exacerbation of symptoms in asthma, see Non-steroidal anti- inﬂammatory drugs p. 1193

Source pages 1229, 1230

Conception And Contraception

▶With systemic use Caution—long-term use of some NSAIDs is associated with reduced female fertility, which is reversible on stopping treatment.

Source page 1230

Pregnancy

▶With systemic use Avoid unless the potential beneﬁt outweighs the risk. Avoid during the third trimester (risk of closure of fetal ductus arteriosus in utero and possibly persistent pulmonary hypertension of the newborn); onset of labour may be delayed and duration may be increased. ▶With topical use Patient packs for topical preparations carry a warning to avoid during pregnancy.

Source page 1230

Breast Feeding

▶With systemic use Use with caution during breast-feeding. Amount probably too small to be harmful but manufacturers advise avoid. ▶With topical use Patient packs for topical preparations carry a warning to avoid during breast-feeding.

Source page 1230

Hepatic Impairment

▶With systemic use Manufacturer advises caution in mild to moderate impairment; avoid in severe impairment. ▶With topical use Manufacturer advises caution.

Source page 1230

Renal Impairment

▶With systemic use Avoid if possible or use with caution. Avoid in severe impairment. ▶With topical use Deterioration in renal function has also been reported after topical use. Dose adjustments ▶With systemic use The lowest effective dose should be used for the shortest possible duration. Monitoring ▶With systemic use In renal impairment monitor renal function; sodium and water retention may occur and renal function may deteriorate, possibly leading to renal failure.

Source page 1230

Dose and formulations

Extracted information for Ketoprofen only.

Directions For Administration

▶With topical use For topical preparations apply with gentle massage only.

Source page 1230

Medicinal Forms

There can be variation in the licensing of different medicines containing the same drug. Forms available from special-order manufacturers include: gel Modified-release capsule CAUTIONARY AND ADVISORY LABELS 21, 25 ▶Larafen CR (Ennogen Pharma Ltd) Ketoprofen 200 mg Larafen CR 200mg capsules | 28 capsule P £19.08 DT = £23.85 ▶Oruvail (Sanofi) Ketoprofen 100 mg Oruvail 100 modified-release capsules | 56 capsule P £23.93 DT = £23.93 Ketoprofen 200 mg Oruvail 200 modified-release capsules | 28 capsule P £23.85 DT = £23.85 ▶Valket Retard (Tillomed Laboratories Ltd) Ketoprofen 200 mg Valket 200 Retard capsules | 28 capsule P £10.70 DT = £23.85 Gel CAUTIONARY AND ADVISORY LABELS 11 EXCIPIENTS: May contain Ethanol, fragrances ▶Ketoprofen (Non-proprietary) Ketoprofen 25 mg per 1 gram Ketoprofen 2.5% gel | 50 gram P £2.02 DT = £1.71 | 100 gram P £3.42–£3.44 ▶Oruvail (Sanofi) Ketoprofen 25 mg per 1 gram Oruvail 2.5% gel | 100 gram P £6.84 ▶Powergel (A. Menarini Farmaceutica Internazionale SRL) Ketoprofen 25 mg per 1 gram Powergel 2.5% gel | 50 gram P £3.06 DT = £1.71 | 100 gram P £5.89 ▶Tiloket (Tillomed Laboratories Ltd) Ketoprofen 25 mg per 1 gram Tiloket 2.5% gel | 50 gram P £3.00 DT = £1.71 | 100 gram P £6.00

Source page 1230

Clinical care

Extracted information for Ketoprofen only.

Patient And Carer Advice

▶With topical use For topical preparations, patients and their carers should be advised to wash hands immediately after use. Photosensitivity Patients should be advised against excessive exposure to sunlight of area treated in order to avoid possibility of photosensitivity. Patients should be advised not to expose area treated to sunbeds or sunlight (even on a bright but cloudy day) during, and for two weeks after stopping treatment; treated areas should be protected with clothing.

Source page 1230

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.

100–200 mg once daily

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

Candidate age grouping · source page 1229

Adults

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

Apply 2–4 times a day for up to 7 days,

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

Candidate age grouping · source page 1229

Adults

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

Apply 2–3 times a day for up to max. 10 days

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

Candidate age grouping · source page 1229

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

ketoprofen

Reference monograph

Part of registered formulation

KETOPROFEN + CAPSICUM OLEORESIN

Reference record: Ketoprofen
Source: BNF 80 (2020–2021)
Printed source pages: 1229, 1230
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 Ketoprofen only.

Indications And Dose

Source page 1229

Contra Indications

Source page 1229

Cautions

Source page 1229

Allergy And Cross Sensitivity

Source page 1230

Exceptions To Legal Category

▶With topical use Smaller pack sizes of gel preparations may be available on sale to the public.

Source page 1230

Safety

Extracted information for Ketoprofen only.

Interactions

→Appendix 1: NSAIDs

Source page 1229

Side Effects

Source pages 1229, 1230

Conception And Contraception

▶With systemic use Caution—long-term use of some NSAIDs is associated with reduced female fertility, which is reversible on stopping treatment.

Source page 1230

Pregnancy

Source page 1230

Breast Feeding

Source page 1230

Hepatic Impairment

▶With systemic use Manufacturer advises caution in mild to moderate impairment; avoid in severe impairment. ▶With topical use Manufacturer advises caution.

Source page 1230

Renal Impairment

Source page 1230

Dose and formulations

Extracted information for Ketoprofen only.

Directions For Administration

▶With topical use For topical preparations apply with gentle massage only.

Source page 1230

Medicinal Forms

Source page 1230

Clinical care

Extracted information for Ketoprofen only.

Patient And Carer Advice

Source page 1230

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.

100–200 mg once daily

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

Candidate age grouping · source page 1229

Adults

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

Apply 2–4 times a day for up to 7 days,

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

Candidate age grouping · source page 1229

Adults

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

Apply 2–3 times a day for up to max. 10 days

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

Candidate age grouping · source page 1229

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.