Dex-Ketoprofen Trometamol

Symptomatic treatment of pain and inflammation of mild or moderate intensity, such as musculo-skeletal pain, menstrual pain, & dental pain.

Description: Dexketoprofen is an isomer of ketoprofen. It is a propionic acid derivative with analgesic, anti-inflammatory and antipyretic properties. It is a non-steroidal anti-inflammatory drug (NSAID) that reduces prostaglandin synthesis via inhibition of cyclooxygenase pathway (both COX-1 and COX-2) activity.

Onset: About 30 min.
Duration: About 4-6 hr.

Adult: 12.5 mg every 4-6 hr or 25 mg every 8 hr. Max: 75 mg/day.

Elderly: Initial total daily dose should not exceed 50 mg/day. May increase to the doses recommended for general population only if well tolerated.

Mild renal impairment: Reduce initial dose to 50 mg/day. Not to be used in moderate to severe renal impairment.

Mild to moderate impairment: Reduce initial dose to 50 mg/day. Not to be used in severe hepatic impairment.

Any of the following drugs cannot be used at the same time while taking Dexketoprofen. Other non-steroidal anti-inflammatory drugs, anticoagulant medicines; lithium; methotrexate; hydantoins (a type of medicine used for epilepsy) or some antibiotics of sulphonamide type (e.g. sulfamethoxazole); medications used to treat high blood pressure (ACE inhibitors, diuretics and beta blockers); pentoxifylline; zidovudine; cyclosporine or tacrolimus; some oral medicines for diabetes (sulphonylureas); thrombolytic medicines; probenecid; cardiac glycosides; mifepristone; and quinolone antibiotics.

Hypersensitivity to Dexketoprofen, or other NSAIDs. Patients with history of asthma attacks, bronchospasm, angioedema, urticaria, acute rhinitis or nasal polyps that were precipitated by Aspirin or other NSAIDs. Active/suspected/recurrent peptic ulcer or haemorrhage. Chronic dyspepsia; GI bleeding or other active bleedings; Crohn's disease or ulcerative colitis; bronchial asthma; severe heart failure; severe hepatic impairment; moderate to severe renal impairment; haemorrhagic diathesis and other coagulation disorders. Pregnancy and lactation.

Dexketoprofen may cause some unwanted effects in some patients. These are described below and are characteristic of non steroidal anti-inflammatory drugs:

• Common (1 - 10%): nausea, vomiting, diarrhoea, stomach pain or heartburn.
• Uncommon (0.1 - 1%): sleep disorders, nervousness, headache, dizziness,vertigo, palpitations, constipation, dry mouth, flatulence, skin rash, fatigue, hot flushes, shivering, general malaise.
• Rare (0.01-0.1%): stomach ulceration, gastric haemorrhage or perforation, pins and needles, high blood pressure, water retention, slowed breathing rate, increased hepatic enzymes, increased sweating.
• Very rare / isolated cases (<0.01%): blurred vision, ringing in the ear, low blood pressure, haematological reactions, hepatic or renal damage, dermatological and photosensitivity reactions, bronchospasm or anaphylaxis.

In patients with systemic lupus erythematosus or mixed connective tissue disease, anti-inflammatory medicines may rarely cause isolated cases of fever, headache and rigidity of the nape (back of the neck).

The use of Dexketoprofen tablets during pregnancy or breast-feeding is not recommended

Administer activated charcoal if more than 5 mg/kg has been ingested by an adult or a child within an hr. Symptomatic therapy should be provided. Dexketoprofen is dialysable.

Store at a cool & dry place protected from light and moisture. Keep out of reach of children.

Dexketoprofen (25 mg)