Composition: each 3 ml contains diclofenac sodium 75 mg.

Pharmacological properties:

DICLON contains diclofenac sodium, a non-steroidal compound with pronounced antirheumatic, anti-inflammatory, analgesic, and antipyretic properties. Inhibition of prostaglandin biosynthesis, is considered to be fundamental to its mechanism of action. Prostaglandins play an important role in causing inflammation, pain and fever. After administration of 75 mg diclofenac by intramuscular injection, absorption sets in immediately, and mean peak plasma concentrations of about 2.5 micrograms/mL (8 micromole/L) are reached after about 20 minutes.

Indications:

It is used for the relief of pain and inflammation in various conditions:
– Musculoskeletal and joint disorders such as rheumatoid arthritis , osteoarthritis, and ankylosing spondylitis .
– Peri-articular disorders such as bursitis and tendonitis.
– Soft tissue disorders such as sprains and strains.
– Other painful conditions such as renal colic, acute gout, dysmenorrhea, following surgical procedures, severe migraine attacks.
Its also used for the treatment of fever.

Contraindications:

Known hypersensitivity to the active substance.
Active gastric or intestinal ulcer, bleeding or perforation.
Last trimester of pregnancy.
Severe hepatic ,renal and cardiac failure.
Like other non-steroidal anti-inflammatory drugs (NSAIDs), DICLON is also contraindicated in patients in whom attacks of asthma, urticaria, or acute rhinitis are precipitated by acetylsalicylic acid or other NSAIDs.

Warnings:

allergic reactions, including anaphylactic reactions, can also in rare cases without earlier exposure to diclofenac.
DICLON may mask the signs and symptoms of infection due to its pharmacodynamic properties.
The concomitant use of DICLON with systemic NSAIDs including cyclooxygenase-2 selective inhibitors, should be avoided due to the absence of any evidence demonstrating synergistic benefits and the potential for additive undesirable effects.
Combination therapy with protective agents (e.g. proton pump inhibitors or misoprostol) should be considered in patients with a history of ulcer.
Close medical surveillance and caution should also be exercised in patients with ulcerative colitis or Crohn’s disease, as their condition may by exacerbated.
Close medical surveillance is required when prescribing DICLON to patients with impaired hepatic function, impaired cardiac or renal function.
Like other NSAIDs, DICLON may temporarily inhibit platelet aggregation. Patients with defects of haemostasis should be carefully monitored.

Drug interactions:

diclofenac may raise plasma concentrations of lithium and digoxin, Monitoring of the serum levels is recommended. concomitant use of diclofenac with diuretics or antihypertensive agents (e.g. beta-blockers, ACE inhibitors) may cause a decrease in their antihypertensive effect.
Anticoagulants and anti-platelet agents: Caution is recommended since concomitant administration could increase the risk of bleeding.
Concomitant administration of systemic NSAIDs and SSRIs may increase the risk of gastrointestinal bleeding.
Caution is recommended when NSAIDs are administered less than 24 hours before or after treatment with methotrexate, since blood concentrations of methotrexate may rise and the toxicity of this substance be increased.
Diclofenac, like other NSAIDs may increase the nephrotoxicity of cyclosporin due to the effect on renal prostaglandins.
Therefore, it should be given at lower doses.

Usage in pregnancy and lactation:

DICLON should not be used during the first two trimesters of pregnancy unless the potential benefit to the mother outweighs the risk to the fetus.
Like other NSAIDs, diclofenac passes into the breast milk in small amounts. Therefore, DICLON should not be administered during breast feeding in order to avoid undesirable effect in the infant.

Adverse reactions:

Headache, dizziness, Nausea, vomiting, diarrhea, dyspepsia, abdominal pain, flatulence, anorexia. Transaminases increased, Rash. Injection site reaction, pain, and induration.

Overdose:

There is no typical clinical picture resulting from diclofenac overdosage. Overdosage can cause symptoms such as vomiting, gastrointestinal haemorrhage, diarrhea, dizziness, tinnitus or convulsions. Management of acute poisoning with NSAIDs essentially consists of supportive measures and symptomatic treatment.

Dosage and administration:

The dose is generally one 75 mg ampoule daily, given by deep intragluteal injection into the upper outer quadrant. In severe cases (e.g. colic), the daily dose can exceptionally be increased to two injections of 75 mg, separated by an interval of a few hours (one into each buttock). Alternatively, one ampoule of 75 mg can be combined with other pharmaceutical forms of DICLON (e.g. tablets, suppositories) up to a total maximum daily dose of 150 mg.
In migraine attacks, clinical experience is limited to initial use of one ampoule of 75 mg administered as soon as possible, followed by suppositories up to 100 mg on the same day if required. The total dose should not exceed 175 mg on the first day. Intravenous infusion: DICLON must be diluted with saline 0.9% or glucose 5% infusion solution buffered with sodium bicarbonate.

For the treatment of moderate to severe post-operative pain, 75 mg should be infused continuously over a period of 30 minutes to 2 hours. If necessary, treatment may be repeated after a few hours, but the dose should not exceed 150 mg within any period of 24 hours.
For the prevention of post-operative pain, a loading dose of 25 mg to 50 mg should be infused after surgery over 15 minutes to 1 hour, followed by a continuous infusion of about 5 mg per hour up to a maximum daily dose of 150 mg.

Storing Conditions:
Store at temperature (2-30)°C, protected from light.

Packing:
box containing 5-25 ampoules, each ampoule(3m1) contains 75mg.