DECLOPHEN Infantile Suppositories
12.5 & 25 MG
Company name : Pharco Pharmaceuticals
Trade name : Declophen Infantile Suppositories 12.5 & 25
mg
Generic name :
Diclofenac Sodium
COMPOSITION : Each
suppository contains
Diclofenac sodium
12.5 or 25 mg
Pharmaceuticals form
: Suppositories
PHARMACOLOGICAL ACTION:
Declophen is a non-steroidal anti-rheumatic,
anti-inflammatory, analgesic and antipyretic properties. Diclofenac sodium, the
active ingredient in declophen suppositories, has a potent inhibitory effect on
the cyclo-oxygenase pathway of prostaglandin synthesis. This causes a
remarkable decrease in the amount of prostaglandins and, in turn, the response
to pain and inflammatory reactions or injurious agents is abolished.
PHARMACOKINETICS :
Diclofenac shows a
rapid onset of absorption from suppositories. The amount absorbed in linearly
related to the size of the dose. Pharmacokinefic behaviour does not change
after repeated administration. No accumulation occurs provided the recommended
intervals are observed. The plasma concentrations attained in children given
equivalent doses (mg/kg body weight) are similar to those obtained in adults.
INDICATIONS:
Juvenile rheumatoid
arthritis. Post-traumatic and postoperative pain, inflammation, and swelling
e.g. following orthopaedic surgery. As an adjuvant in severe painful
inflammatory infections of the ear, nose. or throat, e.g. pharyngotonsillitis,
otitis. In keeping with general therapeutic principles, the underlying disease
should be treated with basic therapy, as appropriate. Fever alone is not an
indication.
DOSAGE:
Children aged (1 - 12
years): 1 -3 mg/kg per day in divided doses (12.5 mg and 25 mg suppositories
only). Children (aged 6-12 years) with
acute post-operative pain 1 - 2 mg/kg per day in divided doses. Treatment of
acute post-operative pain should be limited to 4 days treatment (12.5 mg and 25
mg suppositories only)
. CONTRAINDICATIONS:
Gastric or intestinal
ulcer. Known hypersensitivity to Diclofenac sodium. Like other non-steroidal
anti-inflammatory drugs, Declophen is contraindicated in patients in whom
attacks of asthma, or acute rhinitis by acetylsalicylic acid or other drugs
with prostaglandins-synthetase
inhibiting activity. It is also contraindicated in
proctitis.
SIDE EFFECTS:
Mild and infrequent gastro-intestinal disturbances
(epigastric pain. nausea ), skin rash, pruritus, headache or oedema might occur
in some patients.
DRUG INTERACTIONS:
Lithium &
digoxin: Declophen may increase plasma concentrations of lithium & digoxin.
Anticoagulants :
Close monitoring of patients is required when receiving concomitant
anticoagulants and Declophen.
Cyclosporins
Cases of nephrotoxicity have been reported in patients
receiving concomitant cyclosporin and Declophen.
Methotrexate
Cases of serious
toxicity have been reported when methotrexate and NSAIDS are given within 24
hours of each other.
Quinolone
antimicrobials
Caution should be exercised when considering the use of
quinolone in patients who are already receiving an NSA ID.
Antidiabetics
Clinical studies have shown that Declophen can be given
together with oral antidiabetic agents without influencing their clinical
effect. However, there have been isolated reports of both hypoglycaemic and
hyperglycaemic effects which have required adjustment to the dosage of
hypoglycaemic agents.
Diuretics
Concomitant treatment with potassium-sparing diuretics may
be associated with increased serum potassium levels, which should therefore be
monitored frequently.
Mifepristone
NSAIDS should not be used for 8 - 12 days after mifepristone
administration.
WARNINGS & PRECAUTIONS:
Use under close medical supervision in case of
gastro-intestinal disorders with a history of gastric or intestinal ulceration,
with ulcerative colitis or with Crohn's disease and in severe impairment of
hepatic function. Like other NSAIDS, Declophen may mask the signs and symptoms
of infection. Avoid concomitant use of two or more NSAIDS. PACKING: A box
containing 5 suppositories. STORAGE: Keep at temperature less than 5° C Keep
all medicines out of the reach of children
