Western Medicine Diclofenac Sodium Suppositority 100mg GMP
Antipyretic Analgesic Non- Steroidal
Diclofenac Sodium Suppositories
Composition: Each suppository contains Diclofenac Sodium 100mg
Suppository base q.s.
Indication: Diclofenac belongs to the group of non- steroidal agents with
marked analgestic and anti-inflammatory properties. It is indicated
in case of severe , acute pain including acute joint inflammations
(arthritis) , gout attacks , chronic joint inflammations ,
especially when several joints are affected
(chronicpolyarthritis/rheumatoid arthritis) . Bechterew's disease
(ankylosing spondytitis ) and other inflammatory rheumatoid
disorders of the spine. Acute inflammatory condition of
degenerative joint or spinal disorders ( arthroses and
spondylarthroses). Soft tissue rheumatisem , Painful swelling or
inflammation after injuries or minor surgeries.
Diclofenac is contraindicated for:
Hypersensitivity to Diclofenac Sodium or other NSAIDS
Hepatic , renal dysfunction,
History of coagulation defects or blood dyscrasias
Inflammatory lesions of recturn or anus
Recent history of rectalor anal bleeding
Peptic ulcer, Gastritis , regional enteritis , Ulcerative Colitis
children and adolescents < 16 years.
The final three months of pregnancy: Diclofenac may inhibit labour
pains and increase the tendency to bleeding. Diclofenac 100 mg
Rectal may only be used after careful consideration by the
physician of the benefits and risks , during the first six months
of pregnancy (agreement by the Physician is absolutely necessary) .
Sometimes local reactions can occur including irritations , bloody
mucous secretion or painful stools.
INTERACTIONS WITH OTHER PHARMACEUTICALS
Diclofenac may increase plasma concencentrations of Lithium and
Digoxin if these substances are administered simultaneously. It may
diminish the effect of dehydrating and blood pressure reducting
agents (diuretics and antigypeertonics). Concomitant treatment with
Potassium-saving diurtics may
be associated with increased Potassium levels in the serum.
Concomitant administration of glucocorticoids or other
anti-inflammatory agents increase the risk of gastro-intestinal
bleeding. If diclofenac is given within 24 hours before or after
the administration of Methotrexate , the concentration of
and its toxic effect may increase. The simultaneous intake of
Acetyl-salicylic Acid reduces the serum concentration of
Dosage and Administrations:
ADULTS: If not otherwise prescribed by the Physician , insert one
suppository daily deep into the anus , preferably after stool. The
duration of administration should be determined by the physician.
Total daily dose should not exceed than 300mg.
Children and adolescents: Diclofenac may not be administered due to
the high content of active ingredient.
Store at a temperature not exceeding 25℃. Do not freeze.
2 strip of 5 suppositories each
CERTIFICATE OF ANALYSIS
|Product Name||Diclofenac Sodium Suppositories||Inspection Date||2016.04.20|
|Manufacturing Date||2016.04.07||Expire Date||2018.04.15|
|Lot No.||160415||Lot Size||163CTNS 20 BOXES|
|TEST ITEM||SPECIFICATIONS||TEST RESULTS|
|Identification||Meet the specification|
|Physicochemical Identification||Positive reaction||complies|
|Ultraviolet identification||Meet the specification||complies|
|weight variation||Meet the specification||complies|
|Melting time limit||Meet the specificaiton||complies|
|Microbial limit||Meet the specification||complies|
|Conclusion||The above product complies with the standard of CP201|