Dicloton 75mg/3ml - Diclofenac Sodium - 25mg

Composition: each 1 ml of solution contains 25mg of diclofenac sodium.


Pharmacotherapeutic group: Nonsteroidalantiinflammatory and antirheumatic product.

 

Indications: in acute forms of pain, including:

  • Neuritis, radiculitis, lumbago, ischialgia;
  • Trauma, post-operative pain;
  • Bursitis, tendinits, myositis;
  • Renal or biliary colics;
  • Osteo- and rheumatoid arthritis;
  • Gout, Bechterew’s disease;
  • Toothache, headache, migraine
  • Algodismenorrhea, gynecological pain syndromes.

 

Contraindications:

  • Hypersensitivity to any active substance, other NSAIDs or to any the excipients.
  • Patients with active, or a history of, gastro-intestinal bleeding or peptic ulcer, bleeding or perforation;
  • Severe hepatic, renal or heart failure;
  • Ischemic heart disease, peripheral arterial disease and/or cerebrovascular disease;
  • Last trimester of pregnancy;
  • Age under 18;
  • History of asthma (for i/v infusions);
  • Operations associated with a high risk of haemorrhage (for i/v infusions);
  • Hypovolaemia or dehydration (for i/v infusions).

 

Dosage and administration:

  • Intramuscularly: 1 ampoule by deep intragluteal injection once daily, (or twice in severe cases). Maximum daily dosage is 150mg (2ampoules).
  • Renal colic: 1 ampoule intramuscularly. A further ampoule may be administered after 30 minutes, if necessary.
  • For the treatment of post-operative pain: 1 ampoule should be infused continuously over a period of 30 minutes to 2 hours. If necessary, treatment may be repeated after 4-6 hours, not exceeding 150mg daily dosage;
  • For prevention of post-operative pain: a loading dose of 25-50mg should be infused after surgery over 15 minutes to 1 hour, followed by a continuous infusion of 5mg/hour up to maximum daily dosage of 150mg.

 

Solution for intravenous infusion: 1 ampoule should be diluted with 100-500 ml of sodium chloride 0,9% solution and buffered with sodium bicarbonate solution (0,5ml of 8,4% or 1ml of 4,2%). Only clear solutions should be used.Dicloton must not be given as an intravenous bolus injection.
Storage conditions: Store below 25°C. Do not refrigerate or freeze.

Packaging: Diclofenac Sodium 75mg/3ml, in packs of 5 ampoules with patient information leaflet in carton box.

Manufacturer: “Medochemie”, Cyprus.