Dexketoprofen film coated tab 25mg
- Drugs List
- Therapeutic Indications
- Precautions and Warnings
- Pregnancy and Lactation
- Side Effects
Oral formulations containing dexketoprofen.
Pain - mild to moderate
Recommended dosage is 12.5 mg every 4 to 6 hours or 25 mg every 8 hours. Total daily dose should not exceed 75 mg.
It is recommended to start the therapy at the lower end of the dosage range (50 mg total daily dose). The dose may then be increased to normal adult dosage once a good tolerance for the drug has been established.
Patients with Renal Impairment
Creatinine clearance 60 to 89 ml/minute: start therapy at reduced doses (50 mg total daily dose).
The Renal Drug Handbook recommends the following doses:
Glomerular Filtration Rate (GFR)
GFR 20 to 50 ml/minute: Dose as in normal renal function but use with caution.
GFR 10 to 20 ml/minute: Dose as in normal renal function but avoid if possible.
GFR less than 10 ml/minute: Dose as in normal renal function but only if on dialysis.
Patients with Hepatic Impairment
Mild to moderate hepatic impairment: start therapy at reduced doses (50 mg total daily dose) under close supervision.
Children under 18 years
Photoallergic or phototoxic reactions to fibrates
History of asthma
History of coagulopathy
History of gastrointestinal ulceration
Nasal polyps, angioedema, and bronchospastic reactivity to NSAIDs
Renal impairment - creatinine clearance below 60ml/minute
Severe cardiac failure
Severe hepatic impairment - Child-Pugh score greater than or equal to 10
Third trimester of pregnancy
Precautions and Warnings
Disorders aggravated by fluid retention
Females attempting to conceive
Recent major surgery
Congestive cardiac failure
Connective tissue disorder
First trimester of pregnancy
Ischaemic heart disease
Renal impairment - creatinine clearance 60-89ml/minute
Second trimester of pregnancy
Systemic lupus erythematosus
May mask symptoms or signs of infections
Advise ability to drive/operate machinery may be affected by side effects
Maintain adequate hydration during therapy
Discontinue if signs of gastro-intestinal bleeding occur
GI symptoms / history of GI disease: monitor for digestive disturbances
May inhibit platelet aggregation - observe for signs of bleeding
Monitor blood counts regularly
Monitor dosage closely in presence of renal or hepatic impairment
Monitor hepatic function regularly in mild / moderate hepatic impairment
Monitor patient with history of severe cardiac disease for signs of failure
Monitor patients with renal impairment
Discontinue if signs of gastro-intestinal ulceration occur
May prolong bleeding time
Risk of gastro-intestinal bleeding increased in the elderly
Discontinue if liver function disturbance occurs
Discontinue if severe hypersensitivity reactions occur
Discontinue treatment if skin rash or other allergic reaction occurs
Maintain treatment at the lowest effective dose
Not for long term use
May cause impaired fertility
Patients with a history of gastrointestinal toxicity, particularly the elderly, should be advised to report any unusual abdominal symptoms (especially gastrointestinal bleeding), particularly at the initial stages of treatment. Combination therapy with protective agents should also be considered in these patients.
NSAIDs can increase plasma urea nitrogen and creatinine. As with other inhibitors of prostaglandin synthesis, it can be associated with adverse effects on the renal system which can lead to glomerular nephritis, interstitial nephritis, renal papillary necrosis, nephrotic syndrome and acute renal failure.
NSAIDs can cause transient small increases in some liver parameters, and also significant increases in SGOT and SGPT. In the case of a relevant increase in such parameters, therapy must be discontinued.
Patients with uncontrolled hypertension, congestive heart failure, established ischaemic heart disease, peripheral arterial disease, and/or cerebrovascular disease should only be treated with dexketoprofen after careful consideration. Similar consideration should be made before initiating longer-term treatment of the patients with risk factors for cardiovascular disease (e.g. hypertension, hyperlipidaemia, diabetes mellitus and smoking).
Pregnancy and Lactation
Dexketoprofen is contraindicated during the third trimester of pregnancy but may be used with caution during the first and second trimester.
Use of dexketoprofen during the third trimester of pregnancy is contraindicated by the manufacturer.
The risks are predominately concerned with the effect on embryo/foetal development and adverse effects on the pregnancy due to the inhibition of prostaglandin synthesis, such as, increased risk of miscarriage, cardiac malformation and gastroschisis. During the third trimester, exposure to all prostaglandin synthesis inhibitors can expose the foetus to premature closure of the ductus arteriosus, pulmonary hypertension and renal failure with oligohydramnios. If exposure to dexketoprofen occurs within the third trimester it is essential to monitor foetal development. Exposure to prostaglandin synthesis inhibitors at the end of pregnancy can cause prolonged bleeding in both neonate and mother, and delayed or prolonged labour.
Dexketoprofen should only be given in the first and second trimester if absolutely necessary. In such cases, dose should be kept low and duration as short as possible.
Dexketoprofen is contraindicated during breastfeeding.
Use of dexketoprofen when breastfeeding is contraindicated by the manufacturer. At the time of writing insufficient information is available to assess the effect/s of dexketoprofen during lactation and therefore potential harm to the infant cannot be ruled out.
Ibuprofen is the drug of choice during breastfeeding (Schaefer, 2015).
Abnormal liver function tests
Bone marrow hypoplasia
Congestive cardiac failure
Exacerbation of Crohn's disease
Increases in hepatic enzymes
Peptic ulceration with perforation and haemorrhage
Renal papillary necrosis
It is strongly recommended that the UK National Poisons Information Service be consulted on cases of suspected or actual overdose where there is doubt over the degree of risk or about appropriate management.
The following number will direct the caller to the relevant local centre (0844) 892 0111
Information may be obtained if you have access to ToxBase the primary clinical toxicology database of the National Poisons Information Service. This is available via password on the internet ( www.toxbase.org ) or if this is unavailable at the backup site ( www.toxbasebackup.org ).
Last Full Review Date: August 2021
Summary of Product Characteristics: Keral. A. Menarini Farmaceutica Internazionale SRL. Revised May 2021.
The Renal Drug Handbook. Fifth Edition (2019) ed. Ashley, C. and Dunleavy, A. Radcliffe Publishing Ltd, London.
Drugs During Pregnancy and Lactation: Treatment Options and Risk Assessment, 3rd edition (2015) ed. Schaefer, C., Peters, P. and Miller, R. Elsevier, London.
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