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NSAID Pregnancy: Section 4.6: 'safety in human pregnancy and lactation cannot be assumed and, in common with other NSAIDs, Surgam should not be used during the first two trimesters of pregnancy or labour unless the potential benefit to the patient outweighs the potential risk to the fetus.' From the 20th week of pregnancy onward, use may cause oligohydramnios from fetal renal dysfunction, and ductus arteriosus constriction has been reported after second-trimester treatment; during the first and second trimester the dose should be kept as low and duration as short as possible and antenatal monitoring considered. 'Surgam is contraindicated during the third trimester of pregnancy.' Breast-feeding: milk level approximately 0.2% of the administered dose, unlikely to be of pharmacological significance; breast-feeding or treatment of the mother should be stopped as necessary. Fertility: may impair female fertility (section 4.4).

Tiaprofenic acid

Brand names: Surgam

Tiaprofenic acid is a non-steroidal anti-inflammatory drug used for pain and inflammation in rheumatic disease and other musculoskeletal disorders.

Adult dose

Dose: Adults: 600 mg daily in divided doses, as 300 mg twice a day or, alternatively, 200 mg three times a day (rheumatoid arthritis, osteoarthritis, ankylosing spondylitis, low back pain, musculoskeletal disorders such as fibrositis, capsulitis and epicondylitis and other soft-tissue inflammatory conditions, sprains and strains, post-operative inflammation and pain and other soft tissue injuries). Elderly: as for adults.
Route: Oral (swallowed whole, preferably with or after food)
Frequency: Twice daily (300 mg) or, alternatively, three times daily (200 mg)
Strength: Surgam Tablets 300 mg, each tablet containing 300 mg tiaprofenic acid (SPC section 2). The tablets are to be swallowed whole (section 4.2), so the SPC's 200 mg doses require a strength other than the 300 mg tablet covered by this SPC. The SPC prints no maximum dose beyond the 600 mg daily regimen. Lowest effective dose for the shortest duration necessary to control symptoms (section 4.4). Elderly patients: NSAIDs should be used with particular caution; if an NSAID is considered necessary they should receive the lowest effective dose for the shortest possible duration and be monitored regularly for gastrointestinal bleeding after initiation. Patients with a history of GI toxicity or ulcer, and the elderly, should commence on the lowest dose available, and combination with a protective agent (misoprostol or a proton pump inhibitor) should be considered (section 4.4). Stop immediately if urinary symptoms (frequency, urgency, dysuria, nocturia, haematuria) occur - cystitis may become severe if treatment continues (section 4.4).

Dose adjustments

Renal

SPC section 4.2: in cases of renal, cardiac or hepatic impairment the dosage should be kept as low as possible, and it is suggested that the dosage be reduced to 200 mg twice daily. Section 4.3 contraindicates severe renal failure; section 4.4 advises caution in chronic renal insufficiency with particularly careful monitoring of renal function.

Hepatic

SPC section 4.2: in cases of renal, cardiac or hepatic impairment the dosage should be kept as low as possible, and it is suggested that the dosage be reduced to 200 mg twice daily. Section 4.3 contraindicates severe hepatic failure; section 4.4 advises caution in patients with a history of hepatic insufficiency.

Dose independently re-sourced from UK Summary of Product Characteristics (SPC) via MHRA Products — clinician-reviewed. Always confirm against the product SmPC and your local formulary before prescribing.

Contraindications

  • Active or history of recurrent peptic ulcer/haemorrhage (two or more distinct episodes of proven ulceration or bleeding) (section 4.3)
  • History of gastrointestinal bleeding or perforation related to previous NSAID therapy (section 4.3)
  • Active bladder or prostatic disease or symptoms (section 4.3)
  • History of recurrent urinary tract disorders (section 4.3)
  • Hypersensitivity to tiaprofenic acid or any excipient; previous hypersensitivity reactions (asthma, rhinitis, angioedema or urticaria) to ibuprofen, aspirin or other NSAIDs (section 4.3)
  • Last trimester of pregnancy (section 4.3)
  • Severe heart failure, hepatic failure and renal failure (section 4.3)
  • Must not be given to patients with a history of asthma (section 4.4)

Side effects

  • Very common: upper abdominal pain (section 4.8)
  • Common: nausea, vomiting, dyspepsia, diarrhoea; non-specific allergic reactions, bronchospasm, dyspnoea; dizziness; cystitis (section 4.8)
  • Urinary symptoms and cystitis - tiaprofenic acid appears to have a greater propensity than other NSAIDs to generate reports of cystitis; also bladder pain, dysuria, pollakiuria, haematuria (sections 4.4, 4.8)
  • Gastrointestinal bleeding, ulceration and perforation, which can be fatal, particularly in the elderly (sections 4.4, 4.8)
  • Serious skin reactions including Stevens-Johnson syndrome and toxic epidermal necrolysis, most often within the first month; photosensitivity reaction; rash, pruritus, urticaria, angioedema (sections 4.4, 4.8)
  • Sodium and fluid retention with oedema (sections 4.4, 4.8)
  • Hepatitis, jaundice, abnormal liver function test; prolonged bleeding time (section 4.8)
  • Nephrotoxicity including tubulo-interstitial nephritis, nephrotic syndrome and renal failure (section 4.8)
  • Thrombocytopenia, anaemia due to bleeding; vertigo, tinnitus, drowsiness (section 4.8)
  • May impair female fertility; not recommended in women attempting to conceive (section 4.4)

Interactions

  • Heparin and other highly protein-bound drugs - co-administration not recommended; dosage modification may be needed with hypoglycaemic agents, phenytoin and diuretics (section 4.5)
  • Oral sulphonylurea hypoglycaemic agents - inhibition of metabolism, prolonged half-life and increased risk of hypoglycaemia reported (section 4.5)
  • Anticoagulants and antiplatelet agents (heparin, vitamin K antagonists, ticlopidine, clopidogrel, dabigatran, apixaban, rivaroxaban, edoxaban) - increased risk of bleeding; unsafe in combination; if unavoidable monitor closely (section 4.5)
  • Other NSAIDs including COX-2 selective inhibitors and high-dose salicylates - avoid (sections 4.4, 4.5)
  • Corticosteroids and nicorandil - increased risk of gastrointestinal ulceration, perforation or bleeding (sections 4.4, 4.5)
  • Cardiac glycosides - NSAIDs may exacerbate cardiac failure, reduce GFR and increase plasma glycoside levels (section 4.5)
  • Methotrexate - decreased elimination; avoid with high-dose methotrexate, caution with low-dose (section 4.5)
  • Lithium - decreased elimination; monitor lithium levels (section 4.5)
  • Diuretics - reduced diuretic and antihypertensive effect, increased risk of renal impairment and hyperkalaemia (section 4.5)
  • Tenofovir disoproxil fumarate - may increase the risk of renal failure; tacrolimus - possible increased nephrotoxicity (section 4.5)
  • Mifepristone - do not use NSAIDs for at least 8-12 days after mifepristone (section 4.5)

Monitoring

  • Regular medical supervision in long-term NSAID treatment (section 4.4)
  • Renal function - particularly careful monitoring in chronic renal insufficiency; urine volume and renal function at the start of therapy in patients with hypertension, cardiac insufficiency, liver cirrhosis, nephrotic syndrome or on diuretics (section 4.4)
  • Urinary symptoms (frequency, urgency, dysuria, nocturia, haematuria) - stop immediately and perform urinalysis and urine culture (section 4.4)
  • Gastrointestinal bleeding, especially in the elderly and with a history of GI toxicity (sections 4.2, 4.4)
  • Serum lithium levels if given concomitantly (section 4.5)
  • Withdraw at the first sign of skin rash, mucosal lesions or other hypersensitivity (section 4.4)

Clinical monograph

How it works

It inhibits cyclo-oxygenase, reducing prostaglandin synthesis and producing anti-inflammatory and analgesic effects.

Prescribing in practice

  • It can cause severe cystitis and urinary symptoms, and should be stopped immediately and not restarted if urinary frequency, pain, urgency or haematuria develops.
  • As with all NSAIDs it carries gastrointestinal, cardiovascular and renal risks and should be used at the lowest effective dose for the shortest time.
  • It interacts with anticoagulants, other NSAIDs, diuretics, ACE inhibitors and lithium; avoid in patients with active peptic ulceration or significant renal impairment.

Monitoring

Monitor for urinary symptoms, renal function and gastrointestinal tolerability, particularly during prolonged use.

Counselling the patient

  • Stop the medicine and tell your doctor at once if you develop bladder symptoms such as needing to pass urine often, pain on passing urine, or blood in the urine.
  • Take it with or after food and report indigestion or black stools.
  • Avoid combining it with other anti-inflammatory painkillers unless advised.

Evidence & guidelines

The MHRA has highlighted the risk of severe cystitis with tiaprofenic acid, advising prompt discontinuation if urinary symptoms occur.

Reference: MHRA; Drug verified in RxNorm (NLM); confirm dosing against the manufacturer SPC (eMC). Verify against your local formulary and current prescribing references before prescribing. The structured dose values shown have been reviewed by a clinician. Monograph status: clinician-reviewed (2026-07-04).

Related

Curated clinical cross-links plus same-class fallbacks.

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