FELORAN
-
| StockNo |
Product description |
| EB0280-421-08 |
FELORAN
(DICLOFENAC) AMPOULE 75 MG/3 ML (2.5%) |
| EB0280-421-20 |
FELORAN
(DICLOFENAC) SUPPOSITORIES CHILDREN 25 MG X 6 |
| EB0280-421-21 |
FELORAN
(DICLOFENAC) SUPPOSITORIES ADULTS 50 MG X 6 |
-
- COMPOSITION:
Diclofenac sodium
- 75 mg/3 ml in one ampoule
25 mg and 50 mg in one suppository
ACTION:
Feloran is a representative of the group of non-steroid
antiphlogistic agents, derivatives of phenylacetic acid. It has a
marked analgesic and antipyretic action. It inhibits prostaglandin
synthesis.
PHARMACOKINETICS:
It is rapidly and fully absorbed after oral administration. It is
metabolized, and some of the metabolites are also active, though
less intensively. It binds to serum proteins up to 99%. It is mainly
excreted through the kidneys (60 %), up to 40 % being eliminated
with the urine within 12 h. it is also excreted through the bile and
a small part with the feces. It does not cumulate. The maximum
concentration after a single administration of 50 mg is 1 mg/ml
within 2 h. the intake after meals delays the time for attending the
maximum concentrations.
INDICATIONS:
Inflammatory and degenerative articular diseases; rheumatoid
arthritis, ankylosing spondylarthritis (Bechtew's disease), gout,
arthrosis, spondylarthosis, particular diseases, periarthritis,
muscular rheumatism, painful inflammatory states of nonrheumatic
origin, neuralgia, neuritis, posttraumatic syndrome, etc.
CONTRAINDICATIONS:
Pregnancy, especially during the first three months; ulcer disease
of the duodenum and stomach; in severe hepatic and renal injuries.
To be very cautiously administered to patients with urticaria, acute
rhinitis, simultaneous administration with anticoagulants. |
SIDE EFFECTS:
It is well tolerated and the induced side effects are from the
gastrointestinal tract (nausea, vomiting, eructation, epigastric
pain, diarrhea). Sometimes a slight dizziness and headache are
observed.
PRECAUTIONS:
The half-life of the active metabolites is prolonged in renal
insufficiency, which necessitates the reduction of the therapeutic
doses.
DRUG INTERACTIOPNS:
Plasma concentrations of feloran are reduced within statistically
significant limits by the simultaneous administration of
acetysalicytic acid. Due to competitive interactions at the level of
plasma proteins and enhanced effect of oral anticoagulants and of
antidiabetic agents can be observed during simultaneous
administration with feloran.
DOSAGE AND ADMINISTRATION:
Suppositories - adults: the daily dose ranges from 100 to 150 mg
according to the severity of the disease. For children over 6 years
of age - the dose is 2-3 mg/kg body weight daily. In case of
nocturnal pain - one suppository in the evening at bedtime.
Ampoules - adults: 1 ampoule is injected deeply intramuscularly.
Another ampoule can be injected 12 h later in severe cases. In case
of improvement the injection can be substituted for tablets or
suppositories in respective doses.
MEDICINAL FORM AND PACKAGE:
Packages with 10 ampoules of 75 mg/3 ml (2.5 %).
Packages with 6 suppositories of 25 mg for children and 50 mg for
adults.
STORAGE:
At moderate temperature (15-30° C), in a place protected from
light.
EXPIRY:
2 (two) years.
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