| ERDON-100
TR
Diclofenac Sodium
Description:
Diclofenac is a non-steroidal, anti-inflammatory
& analgesic properties. Erdon-100 TR is encapsulated
timed release dosage form possesses small microencapsulated
pellets which are coated usually with different thickness having
a desired steady drug release pattern for prolong time
Composition:
Each Erdon-100 TR capsule contains timed
release Diclofenac Sodium pellets equivalent to 100 mg Diclofenac
Sodium BP.
Indications:
Rheumatology: Inflammatory and degenerative forms
of rheumatism, chronic involutive polyarthritis, ankylosing
spondylitis, osteoarthritis, spondyl arthrocse, acute gout,
peri-articular rheumatic disorders.
Surgery and Traumatology: Sprain, bruises, dislocations,
fractures, soft-tissue injuries, surgical interventions.
Obstetrics and Gynaecology: Primary dysmenorrhoea,
episiotomy, adnexitis, endometritis, parametritis, salpingitis,
mastitis.
Otorhinolaryngology : As pre-operative medication
for the prevention of pain, inflammation and swelling.
Dentistry: Post-operative and post-traumatic
pain, inflammation and swelling.
Other indications: For the prevention of pain
and treatment of inflammation and swelling of patients operated
in the urogenital tract, renal and biliary colic.
Dosage and Administration:
One capsule of Erdon-100 TR daily. If
necessary, the daily doses can be increased to 150 mg, by prescribing
in addition Erdon-50 enteric coated tablets of 50 mg. Where
the symptoms are most pronounced during the night or in the
morning, Erdon-100 TR should preferably be taken in the
evening. It should be taken with little liquid preferably at
mealtimes.
Contraindications:
Peptic ulcer, hypersensitivity to diclofenac.
Like other non-steroidal anti-inflammatory agents, diclofenac
sodium is also contraindicated in asthmatic patients in whom
attacks of asthma, urticaria or acute rhinitis are precipitated
by acetylsalicylic acid or by other drugs with prostaglandin
synthetase inhibiting activity.
Precautions:
In the rare instance where peptic ulceration
or gastro-intestinal bleeding occurs in patients under treatment
with Erdon-100 TR, the therapy should be discontinued.
In patients with advanced age, caution is indicated on basic
medical grounds. During prolonged treatment with Erdon-100
TR, blood counts and monitoring of hepatic and renal function
are indicated as precautionary measures.
Pregnancy & lactation:
Erdon-100 TR should be employed only for
compelling reasons and only in the lowest doses that still prove
necessary. As in the case of other prostaglandin-synthetase
inhibitors, this applies particularly to the last 3 months of
pregnancy (owing to the possibility of uterine inertia and/or
premature closure of the ductus arteriosus
Following oral doses of 150 mg daily diclofenac
passes into the breast milk, but in quantities so small that
no undesirable effects on the infant are to be expected.
Side-effects:
Erdon-100 TR is generally well tolerated.
At the starting of the treatment, however, patients may sometimes
complain of epigastric pain, eructation, nausea and diarrhoea,
or of dizziness or headache. These effects are usually of mild
nature. Peripheral oedema and skin reactions, such as rash and
eczema have also been encountered.
The following unwanted effects, which have been
observed in response to other ono-steroidal anti-inflammatory
drugs, have seldom been reported with Erdon-100 TR i.e.
central nervous side effects, such as tiredness, insomnia or
irritability. There have been a few reports at gastro-intestinal
ulveration or haemorrhage, hypersensitivity reactions (e.g.
bronchospasm, anaphylactic/anaphylactoid systemic reactions)
elevated transaminase levels, jaundice, hepatitis, renal failure
and nephrotic syndrome.
Storage:
Packing:
Erdon-100 TR Capsule: Box containing 10
x 10's capsule in blister pack. |
