Anti-inflammatory ,analgesic,antirheumatic,antipyretic Diclofenac
Sodium Injection 75mg/3ml 10 ampoules for I.M/I.V use
Each 3 mL contains 75 mg diclofenac sodium with 4% v/v benzyl alcohol.
Antirheumatics (anti-inflammatory agents)
Diclofenac sodium has analgesic, anti-inflammatory, antirheumatic
antipyretic activities. It is non steroidal. It is an inhibitor of
cyclo-oxygenase. Diclofenac is metabolised in the liver to
4-hydroxydiclofenac and other hydroxylated forms, after
glucoronidation and sulphation the metabolites are excreted in the
urine (65%) and bile (35%).
To be used as initial therapy for inflammatory and degenerative
rheumatic diseases, as well as for painful conditions due to
inflammation of non-rheumatic origin and acute attacks of gout.
Patients with known hypersensitivity to diclofenac, or other
non-steroidal anti-inflammatory medicines. Asthmatic patients in
whom attacks of asthma, urticaria or acute rhinitis are
precipitated by acetylsalicylicacid, or other medicines with
prostaglandin synthetase inhibiting activity. Diclofenac sodium is
contra-indicated in patients with a history of active
gastro-intestinal bleeding or peptic ulceration, or severe hepatic
or renal impairment. Patients with porphyria. Safety during
pregnancy and lactation has not been established.
Serious interactions have been reported after the use of
methotrexate with diclofenac.
DOSAGE AND DIRECTIONS FOR USE:
Not intended for intravenous injection. Only for deep intragluteal
injection into the upper quadrant. Seventy five mg by intramuscular
injection once daily or twice daily in severe cases; each injection
should be given at a different site. In renal colic the
intramuscular dose of 75 mg may be repeated once after 30 minutes
if necessary. Diclofenac ampoules should not be given for more than
a few (2) days. If necessary, treatment can be continued with oral
SIDE-EFFECTS AND SPECIAL PRECAUTIONS:
Gastro-intestinal disturbances; reactions range from abdominal
discomfort, nausea and vomiting, and abdominal pain to serious
gastro-intestinal bleeding or activation of peptic ulcer.
CNS-related side-effects include headache, dizziness, nervousness,
tinnitus, depression, drowsiness and insomnia. Hypersensitivity
reactions may occur occasionally and include fever and rashes.
Hepatotoxicity and aseptic meningitis may also be hypersensitivity
reactions. It can provoke bronchospasm in patients with asthma. It
may cause cystitis and haematuria. It may also cause acute renal
failure, interstitial nephritis, and nephrotic syndrome. Other
adverse effects include anaemias, thrombocytopenia, neutropenia,
eosinophilia, agranulocytosis, abnormalities in liver function
tests, blurred vision, changes in visual colour perception, and
toxic amblyopia. It should not be given to patients with active
peptic ulceration. It should be given with care to the elderly, to
patients with asthma or bronchospasm, bleeding disorders,
cardio-vascular-disease, a history of peptic ulceration, and in
liver or renal failure. Patients with congestive heart failure,
cirrhosis, diuretic-induced volume depletion, or renal
insufficiency are at greater risk of developing renal dysfunction
due to NSAID-induced inhibition of renal prostaglandin synthesis.
Care is required in those who are also receiving coumarin
anticoagulants. Patients who are sensitive to aspirin or other
NSAID's should generally not be given diclofenac. Diclofenac should
be discontinued in patients who experience blurred or diminished
vision, or changes in colour vision. Patients with collagen disease
may be at increased risk of developing aseptic meningitis. In view
of the product's inherent potential to cause fluid retention, heart
failure may be precipitated in some compromised patients. When
given together with preparations containing lithium or digoxin,
diclofenac sodium may raise their blood concentrations. Patients
receiving long-term treatment with diclofenac should have periodic
blood counts. Studies have demonstrated a pharmacokinetic
inter-action between diclofenac and salicylates when both are
co-administered in anti-inflammatory doses.
KNOWN SYMPTOMS OF OVERDOSAGE AND ITS TREATMENT:
See "Side-effects and Special Precautions". Treatment is
symptomatic and supportive.
Clear colourless, to a pale yellow solution.
Clear colourless or amber, type 1, glass ampoules in packs of 10.
Protect from heat and light.
Store below 25°C. Do not refrigerate.
KEEP OUT OF REACH OF CHILDREN.
|Name of Drug||Diclofenac Sodium Injection||Batch No.||080606|
|Mfg. Date:||08/2016||Exp. Date||08/2019|
|Sampling date||25/08/2016||Report date||01/09/2016|
|Characteristic:||A clarity and colorless solution||Complies|
|Identification:||Should Positive reaction||Positive reaction|
|Clarity of solution:||Meet the requirement||Complies|
|Color of solution:||Meet the requirement||Complies|