Cinepar-75 Injection

Cinepar 75 (2)a

COMPOSITION:
Each 3 ml contains:
Diclofenac Sodium BP 75 mg
Benzyl Alcohol BP 4% v/v
Water for Injection BP q.s.

INDICATIONS:
Cinepar-75 is indicated for the treatment of:
Intramuscular injection

  • Post traumatic and post operative pain, inflammation and swelling
  • Exacerbations of inflammatory and degenerative forms of rheumatism: rheumatoid arthritis, ankylosing spondylitis, osteoarthritis, spondyloarthritis, non-articular rheumatism
  • Acute attacks of gout
  • Painful conditions due to inflammation of non rheumatic origin
  • Pain caused by kidney stone, injuries & fractures
  • Painful syndromes of the vertebral column
  • Renal colic and biliary colic
  • Severe migraine attacks.

DESCRIPTION:
Pharmacodynamics
Cinepar-75 contains Diclofenac sodium which is a Non steroidal anti-inflammatory drug. It inhibits cyclo-oxygenase, a splice variant of COX-1 and COX-2 and limits the production of prostaglandins.
Pharmacokinetics
Cinepar-75 administered by intramuscular route achieves a mean peak plasma concentration of 2.5µg/ml in 20 minutes. 99.7% of diclofenac is bound to serum proteins, mainly to albumin (99.4%). The apparent volume of distribution is 0.12 to 0.17 L/kg. The terminal half-life in plasma is 1 to 2 hours. About 60% of the administered dose is excreted in the urine as the glucuronide conjugate and the rest of the dose is eliminated as metabolites through the bile in the faeces.

CONTRAINDICATIONS:
Cinepar-75 is contraindicated in conditions of severe hepatic, renal or cardiac failure, active gastric or intestinal ulcer, bleeding or perforation and in patients with known hypersensitivity to Diclofenac sodium. Concomitant NSAID or anticoagulant use including low-dose Heparin with Diclofenac sodium should be avoided. It is also contraindicated in last trimester of pregnancy.

SIDE EFFECTS:
Blood and lymphatic system disorder: Vary rare: Thrombocytopenia, leukopenia and anaemia
Immune system disorder: Rare: Hypersensitivity, anaphylactic and analhylactoid reactions
Nervous system disorder: Common: Headache, dizziness; Rare: Somnolence; Very rare: Paraesthesia, memory impairment and convulsion
Eye disorder: Very rare: Visual disturbance, blurred vision and diplopia
Cardiac disorders: Very rare: Palpitation, chest pain and myocardial infraction

DOSAGE:
Adults
Intramuscular Injection
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 Diclofenac sodium (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
Diclofenac sodium solution for injection must not be given as an intravenous bolus injection. Immediately before starting an intravenous infusion, Diclofenac sodium solution for injection must be diluted with saline 0.9% or glucose 5% infusion solution buffered with sodium bicarbonate according to the instructions given in section method of administration. Two alternative dosage regimens of Diclofenac sodium solution for injection are recommended. 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.

STORAGE CONDITIONS:
Store in a cool, dark & dry place. Keep out of reach of children.

PRESENTATION:
3 ml solution filled in a glass ampoule and such 5 ampoules packed in a carton with insert.
3 ml solution filled in a glass ampoule and such 10 ampoules packed in a carton with insert.