Monograph: |
Biphenyl Acetic Acid
Description
Felban (1,1'-biphenyl)-4 acetic acid is a
non-steroidal agent with marked anti-
inflammatory and analgesic activity.
Each gram (approximately 3 cms. strip)
of Felban Gel contains 30 mg. of Felban.
It is a self-preserving, clear, non-staining,
non-greasy formulation.
Composition
Biphenyl Acetic Acid 3% w/w
Aqueous Base q.s.
Pharmacology and Pharmacokinetics
The anti-inflammatory and analgesic
activity of Felban Gel is associated with
the inhibition of prostaglandin synthesis.
Felban Gel is percutaneously absorbed
and penetrates to the affected tissues
under the applied site, such as muscle,
tendon and synovium. Felban is
metabolised to 4-hydroxy-(1,1 '-biphenyl)
acetic acid and conjugates. The primary
route of elimination is via the kidneys. It
is eliminated unchanged in the urine and
often metabolised to the 4-hydroxy
compound. Both agents are also
eliminated in the urine as conjugates. No
Felban Gel metabolites have been
detected in human blood.
Indications
Felban Gel is indicated for the relief of
symptoms associated with painful
inflammatory conditions of the
musculoskeletal system. Such conditions
include:
โข Soft tissue trauma such as sprains,
strains and contusions.
โข Extra articular rheumatic and
inflammatory conditions including
capsulitis, tendinitis, tenosynovitis,
periarthritis, bursitis, tennis elbow,
frozen shoulder and myalgia.
โข Acute inflammatory manifestations of
osteoarthritis.
- โข Pain and swelling following injury.
Dosage and Administration
Felban Gel should be applied according to
Individual requirement depending on
severity of clinical symptomatology. The
recommended dose is 3-6 g/day rubbed
lightly into the affected areas in two to four
divided doses. The total dose, regardless
of the number of affected areas treated
should not exceed it.
Contraindications
Hypersensitivity to the ingredients of the
product or to other non-steroidal anti-
inflammatory drugs including
acetylsalicylic acid. Felban Gel should
not be administered to patients in whom
attacks of asthma, urticaria or acute
rhinitis are precipitated-by aspirin.or
other non-steroidal anti-inflammatory
agents.
Side Effects
Mild local erythema, dermatitis and
pruritus have been reported in
approximately 2% of the patients.
Spontaneous recovery occurred on
cessation of treatment.
Precautions
There are no specific precautions.
Warnings
Use of the gel should be limited to intact
skin. Contact with mucous membranes or
eyes should be avoided. Felban Gel
should not be applied with occlusive
dressings. Since safe use of this drug is
not been established in pregnancy and
since dystocia and delayed parturition
were observed in animal studies, this drug
should be used in pregnancy only if
benefits clearly outweigh potential risks.
Safe use in early childhood has not been
established.
Interactions
When used as specified, interactions of
Felban Gel with other drugs are not known.
Overdosage
It is unlikely that Felban Gel would cause
adverse systemic effects, even if ingestion
should accidentally occur. The lack of
overdosage experiences precludes
characterization of the sequelae, however
a physician should be consulted in case
of overdose.
PACKAGE INFORMATION
Biphenyl Acetic Acid Gel 3%
Felbanยฎ Gel 3%
Product No.: 9184-34, Tube of 20 g
Tube cap with built in pin for piercing the nozzle tip
DO NOT USE ON BROKEN SKIN, AVOID CONTACT WITH EYES
STORE AT ROOM TEMPERATURE PROTECT FROM
DIRECT SUNLIGHT AND MOISTURE
I FOR EXTERNAL USE ONLY I
KEEP OUT OF THE REACH OF CHILDREN
|