Diclo-k

Diclo-k
27 May

Diclo-k

Analgesics, Antipyretics, Anti-Inflammatory drugs

- Diclofenac Potassium, a phenylacetic acid derivative, is a non-steroidal 
  compound with pronounced antirheumatic, anti-inflammatory, analgesic
  and antipyretic properties. 
- It inhibits prostaglandin biosynthesis which plays a major role in 
  causing inflammation, pain and fever. Medication with Diclofenac 
  Potassium can relieve the symptoms of inflammation, but can not cure 
  the cause. 
- In rheumatic diseases, Diclofenac Potassium elicits a clinical response 
  characterized by marked relief from signs and symptoms such as pain at 
  rest, pain on movement, morning stiffness, and swelling of the joints, as
   well as by an improvement in function. 
- Diclofenac Potassium is almost completely absorbed. Food has no  
  clinical relevant influence on the absorption and bioavailability of 
  Diclofenac Potassium. 
- No accumulation occurs provided the recommended dosage intervals
   are observed even in patients suffering from renal impairment. 
- 99.7% of  Diclofenac Potassium  is bound to serum proteins. It enters 
  the synovial fluid, and reaches higher levels in the synovial fluid than in
   the plasma and remain higher for up to 12 hours. 
- Diclofenac Potassium is subject to first-pass metabolism and then 
  excreted mainly in the urine  (about 65%) but also in the bile (about 
  35%).

Indecation

- DICLO-K® is used in: 
- Postoperative inflammation and pain e.g. following dental or orthopedic 
  surgery.
- Painful post-traumatic pain, inflammatory states, e.g. sprains. 
- Painful and/or inflammatory gynaecological conditions, e.g., primary 
  dysmenorrhoea or adnexitis.  
- Migraine attacks. 
- An adjunct in severe painful inflammatory infections of the ear, nose, or  
   throat, e.g. pharyngotonssillitis and otitis.    
- Painful syndromes of the vertebral column. 
- Non-articular rheumatism. 

Dosage & Administration

- In post-traumatic pains, postoperative cases and in the treatment of 
  severe acute osteoarticular rheumatic pain, the attack dose in adults is in
   the range of 100 - 150 mg per day divided into 2 - 3 divded doses .
- In milder cases as well as for adolescents over 14 years of age, a dose 
  ranging between 50 and 100 mg daily will generally suffice. 
- In primary dysmenorrhea, the daily dosage, which should be 
  individually adjusted, is generally between 50 to 150 mg and, if 
  necessary, it may be raised over the course of other menstrual cycles  
  until it reaches a maximum of 200 mg daily.
- Migraine: An initial dose of 50 mg is recommended at the first sign of
   an impending attack, in cases where pain relief is inadequate approx. 2
   hours after ingestion of the first dose a further dose of 50 mg may be 
  taken. If necessary, further 50 mg dose may be taken at intervals of 4 -
  6 hours, although a  total dose of 200 mg must not be exceeded within 
  a 24 hours period .
- The content of the sachet is to be dissolved in a half glass of natural
   water preferably before meals.  

- Each Sachet of DICLO-K®  Effervescent Granules contains: 
   Diclofenac Potassium     50 mg  

- Peptic and gastric ulcer, hypersensitivity to the components and other 
  substances chemically strictly correlated to them and in particular 
  hypersensitivity to aspirin .   
- DICLO-K® is contraindicated in patients in whom attack of asthma,
  urticaria or acute rhinitis are precipitated or worsened by aspirin or
  other NSAIDs.
- DICLO-K® is also contraindicated in children less than 14 years age.

- When given concomitantly with preparations containing digoxin or 
  lithium, DICLO-K®  may increase their plasma concentrations. 
- Many NSAIDs are capable of inhibiting the activity of diuretics, 
  concomitant treatment with potassium-sparing diuretics may be 
  associated with increased serum potassium level, thus these  should 
  necessarily be checked regularly.
- Although no data in clinical investigations suggested that 
  DICLO-K® could have anticoagulant  effect, there have been isolated 
  reports of an increased risk of haemorrhage in patients receiving it.
- DICLO-K® and an anticoagulant therapy concomitantly, close monitoring 
  of such as patients is therefore  recommended.
- Like other NSAIDs, DICLO-K® at high dosage (200mg) may temporarily 
  inhibit platelet  aggregation.
- Clinical studies have shown that Diclofenac can be given together with 
  oral antidiabetic agents without influencing their clinical effect. 
  However, there have been isolated reports of both  hypoglycemic and 
  hyperglycemic effect during treatment with DICLO-K®  necessitating 
  changes in the antidiabetic drug dosage.
- Special caution is required when NSAIDs are administered less than 24
  hours before treatment with methotrexate, as blood concentrations of 
  methotrexate can rise, increasing its toxicity.
- The effects of NSAIDs on renal prostaglandins may increase the 
  nephrotoxicity of cyclosporine.

- During pregnancy, DICLO-K®  may be administrated only after careful 
  evaluation of risk/ benefit analysis and in any case, with the lowest 
  effective dose. 
- DICLO-K® may not be used during the third trimester of pregnancy 
  owing to possibility of delaying delivery and slackening labour, it is 
  necessary to underline the risk of hemorrhage that can   
  arise from administration of NSAIDS during the terminal phase of 
  pregnancy.
- After oral doses of 50mg every 8hours, DICLO-K® excreted in breast 
  milk is so small that adverse effects in the neonate are unlikely.

- DICLO-K® is generally well tolerated. The most common side effects 
  include disturbances like nausea, vomiting, diarrhea, abdominal cramps, 
  dyspepsia, flatulence, anorexia, peptic ulcer

* As with other NSAIDs, DICLO-K® should be used with caution:
- In patients with impaired hepatic or renal function.
- History of cardiovascular diseases and  peptic ulcer.

 Overdose :
- The procedures of management to be adopted in case of acute
   poisoning with NSAIDs is essentially a procedure of supportive or 
  symptomatic measures.
- In case of overdosage, it is necessary to prevent absorption as soon as 
  possible by means of gastric lavage and activated charcoal.

- DICLO-K® 50 mg / sachet: 
  Pack of  10 sachets  

- Store in a dry place  at a temperature below  30oC.
- Protect from moisture and light.