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Diclofenac Diethyl Ammonium Salt by hyq46512

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									                                ®
Dicloran Gel
( Diclofenac Diethyl (
   Ammonium Salt
DESCRIPTION:
Dicloran® (Diclofenac) is a non steroidal anti-inflammatory drug (NSAID). It inhibits prostaglandins
synthesis by decreasing the activity of the enzyme, cyclo-oxygenease, which results in decreased
formation of prostaglandin precursors

COMPOSITION:
Dicloran® Gel:
Each 100gm contains:
Diclofenac Diethyl Ammonium Salt
equivalent to Diclofenac Sodium BP…... 2gm

PHARMACODYNAMICS:
Dicloran® Gel relieves pain, reduce edema and shorten the time to return to normal function in
inflammation of traumatic or rheumatic origin

PHARMACOKINETICS:
Absorption:
The amount of Diclofenac absorbed through the skin is proportional to the contact time and skin area
covered with Dicloran®Gel, topical dose and hydration of skin

Distribution:
After topical administration to hand and knee joints, Diclofenac can be measured in plasma, synovial
tissue, and synovial fluid

Elimination:
Diclofenac and its metabolites are mainly excreted in urine

INDICATIONS:
Post-traumatic inflammation of the tendons, ligaments, muscles, and joints, e.g. due to sprains, strains,
and bruises. Localised form of soft-tissue rheumatism, e.g. tendovaginitis, bursitis, shoulder-hand
syndrome and periarthropathy. Localised form of degenerative rheumatism, e.g. osteoarthritis of the
peripheral joints and of the vertebral column

DOSAGE AND ADMINISTRATION:
Apply 1 - 2gm Gel 3 to 4 times daily on the affected area and rub gently. After application the hands
should be washed, unless they are the site being treated. The duration of treatment depends on the
indication and the response obtained. It is recommended that treatment be reviewed after 2 weeks
Or as directed by the physician

CONTRA-INDICATIONS:
Known hypersensitivity to Diclofenac or any other ingredient. It is also contra-indicated in patients in
whom attacks of asthma, urticaria or acute rhinitis are precipitated by acetylsalicylic acid or other
NSAIDs

PRECAUTIONS:
It should be applied only to healthy and intact skin surfaces. It should not be allowed to come in contact
with the eyes or with mucous membrane. Not to be taken with mouth. Should be used for topical
application only

PREGNANCY:
Not recommended for use during pregnancy

ADVERSE REACTIONS:
Occasionally allergic or non-allergic contact dermatitis. In isolated cases generalized skin rashes,
hypersensitivity reactions, photosensitivity reactions may occur

STABILITY:
See expiry on the pack

PRESENTATION:
Dicloran® Gel in tube of 20gm

INSTRUCTIONS:
For external use only
Keep out of reach of children
Avoid exposure to heat and light
Store at 25ºC or below
Improper storage may deteriorate the medicine



       Manufactured by:
       SAMI PHARMACEUTICALS (PVT) LTD.
       F-95, S.I.T.E., Karachi-Pakistan


                                                                       09 May 2008 EM 5908 Beupron
                            ®                                                                   Methotrexate , Cyclosporine:
Dicloran
(Diclofenac Sodium)
                                Tablets/Injection                                               Diclofenac like other NSAIDs, through effects on renal prostaglandins, may cause
                                                                                                increase toxicity of certain drugs. Methotrexate serum levels may be elevated as well
                                                                                                as cyclosporine’s nephrotoxicity
COMPOSITION:
Dicloran® 50mg Tablets:                                                                         Lithium:
Each enteric coated tablet contains: Diclofenac Sodium BP..…50mg                                Diclofenac decreases lithium renal clearance and increases its plasma levels. In patients
Dicloran® 50mg Dispersible Tablets:                                                             taking Diclofenac and Lithium concomitantly lithium toxicity may develop
Each dispersible tablet contains: Diclofenac Acid MS equivalent to
Diclofenac Sodium…..50mg                                                                        Diuretics:
Dicloran® SR 100 Tablets:                                                                       Diclofenac and other NSAIDs can inhibit the activity of diuretics. Concomitant treatment
Each film coated tablet contains: Diclofenac Sodium BP…..100mg                                  with potassium sparing diuretics may be associated with increased serum potassium
Dicloran® 75mg Injection:                                                                       levels
Each 3ml contains: Diclofenac Sodium BP…..75mg
                                                                                                DOSAGE AND ADMINISTRATION:
CLINICAL PHARMACOLOGY:                                                                          Tablets:
Pharmacodynamics:                                                                               For the relief of osteoarthritis, the recommended dosage is 100 -150mg/day in divided
Dicloran® (Diclofenac Sodium) is a non steroidal anti-inflammatory drug (NSAID) that            doses (50mg b.i.d. or t.i.d. or 100mg q.d.). For the relief of rheumatoid arthritis the
exhibits anti-inflammatory, analgesic and anti-pyretic properties. It inhibits prostaglandins   recommended dose is 150 - 200mg/day in divided doses (50mg t.i.d. or q.i.d. or 100mg
synthesis by decreasing the activity of the enzyme, cyclo-oxygenease, which results in          q.d. or b.i.d.). For the relief of ankylosing spondylitis, the recommended dose is 100mg/day
decreased formation of prostaglandin precursors                                                 in divided doses
                                                                                                Or as directed by the physician
Pharmacokinetics:
Diclofenac is almost completely absorbed after oral administration. However due to first        Injection:
pass metabolism, only about 50% of the absorbed dose is systemically available. Food            Usually, administered 1 ampoule of 3ml once a day
has no significant effect on the extent of Diclofenac absorption. However, there is usually     Or as directed by the physician
a delay in the onset of absorption of 1 to 4.5 hours. There is also a reduction in peak
plasma levels. Diclofenac is approximately 99% bound to human serum proteins, primarily         STABILITY:
to albumin. Diclofenac is metabolized in liver and major portion of the dose is excreted
                                                                                                See expiry on the pack
in urine and the rest is excreted in the bile

INDICATIONS:                                                                                    PRESENTATIONS:
Dicloran® (Diclofenac Sodium) is indicated for the treatment of signs & symptoms of             Dicloran® 50mg tablet in pack of 2 x 10’s
rheumatoid arthritis, osteoarthritis, low back pain, active musculoskeletal disorders, such     Dicloran® 50mg dispersible tablet in pack of 2 x 10’s
as peri-artheritis, tendonitis, tenosynovitis, bursitis, sprains, strains, and dislocations,    Dicloran® SR 100 tablet in pack of 3 x 10’s
relief of pain in fractures, ankylosing spondylitis, acute gout, control of pain and            Dicloran® 75mg Injection in pack of 5’s
inflammation in orthopedic, dental and other minor surgeries. Other painful and/or
inflammatory conditions like dysmenorrhoea, infections of ear, nose or throat                   INSTRUCTIONS:
                                                                                                Keep out of reach of children
CONTRA-INDICATIONS:                                                                             Avoid exposure to heat, light and humidity
Acute & suspected peptic ulcer or gastro-intestinal bleeding. Known hypersensitivity to         Store at 25ºC or below
Diclofenac or any other NSAID                                                                   Improper storage may deteriorate the medicine

PRECAUTIONS:
Symptoms or history of gastro-intestinal disease, asthma, impaired hepatic, cardiac or
renal function NSAID may mask infections or temporarily inhibit platelet aggregation
In late pregnancy, as with other NSAIDs, it should be avoided as it may cause premature
closure of ductus artetiosus

SIDE EFFECTS:
Occasional gastro-intestinal disorders, headaches, dizziness, vertigo, rashes, elevation
of serum transaminases, local reaction after IM injection. Rare gastric or intestinal ulcer,
gastro-intestinal bleeding, abnormalities of renal function, hypersensitivity reactions

DRUG INTERACTIONS:
Asprin:
When Diclofenac is administered with asprin, its protein binding is reduced. As with other
                                                                                                       Manufactured by:
NSAIDs, concomitant administration of Diclofenac and Asprin is not generally recommended               SAMI PHARMACEUTICALS (PVT) LTD.
because of the potential of increased adverse effects                                                  F-95, S.I.T.E., Karachi-Pakistan



                                                              09 May 2008 EM 5908 Beupron

								
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