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Each
1ml-ampoule contains
20mg of Nefopam HCl.
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| PROPERTIES: |
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Nopain
is a centrally acting analgesic
which is chemically and pharmacologically
distinct from any other class
of analgesics. Nopain is a potent
and rapidly acting analgesic.
Its analgesic action is mediated
through inhibition of synaptosomal
uptake of dopamine, noradrenaline
and serotonin. Analgesia is
not mediated by prostaglandin
inhibition or opiate receptors.
Unlike the narcotic agents,
Nopain has been shown not to
cause respiratory depression
or constipation. Long-term use
of Nopain does not appear to
result in the development of
tolerance or dependence.
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| PHARMACOKINETICS: |
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Virtually
complete absorption occurs following
the intramuscular administration
of Nopain. Peak plasma levels
of 32-49 micrograms / liter
were reported 90 minutes after
20mg intramuscular administration.
The mean plasma half-life is
4 hours. Steady state concentrations
in the cerebrospinal fluid are
usually 25% of the corresponding
plasma concentration, reflecting
the 71-76% plasma protein binding
and free penetration of the
blood-brain barrier.
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| INDICATIONS: |
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Nopain
is indicated for the relief
of acute and chronic pain including:
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Post-operative
pain. |
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Dental
pain. |
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Musculoskeletal
pain. |
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Acute traumatic
pain. |
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Cancer
pain. |
Nopain is also indicated for
the relief of Post-anaesthetic
and Amphotericin B-induced shivering.
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| DOSAGE: |
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One
Nopain ampoule (20mg/ml) intramuscularly,
repeated if necessary every
6 hours.
Onset of action after injection
is within 15-20 minutes and
peak effect is reached at 1
- 1.30 hours after injection.
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| MODE
of ADMINISTRATION: |
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Nopain ampoules
are to be given only through
deep intramuscular injection,
preferably in the upper external
quadrant of the gluteal muscle
with the patient lying down.
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| ADVERSE RECTIONS: |
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Nausea, nervousness,
dry mouth, light headness
and less frequently vomiting,
blurred vision, drowsiness,
sweating, insomnia, headache
and tachycardia have been
reported.
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| CONTRAINDICTIONS: |
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Nopain is contra-indicated
in patients with history of
convulsive disorders and in
patients taking MAO inhibitors.
It should not be used to control
the pain of myocardial infarction
since there is no clinical
experience in this indication.
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| PRECAUTIONS: |
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The adverse
reactions of Nopain may be
additive to those of other
agents with anticholinergic
or sympathomimetic activity.
Caution should be exercised
when nefopam is administered
concurrently with tricyclic
antidepressants, or to patients
with glaucoma, prostatic hypertrophy
or urinary retention, as well
as to elderly patients. Hepatic
and renal insufficiency may
interfere with the metabolism
and excretion of nefopam,
but this is unlikely to be
of clinical signifcance except
perhaps in endstage organ
failure.
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| DRUG INTERACTIONS: |
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Reserpine has
shown to block the analgesic
action of nefopam. The use
of nefopam concurrently with
MAO inhibitors may result
in catastrophic hypertension
as both the synaptosomal reuptake
and elimination by oxidation
of monoamines are inhibited.
The anticholinergic properties
of tricyclic antidepressants
and nefopam are additive. |
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| EFFECTS ON
DIAGNOSTIC TESTS: |
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No
changes were observed
in full blood count, blood
urea nitrogen, alkaline
phosphatase, bilirubin,
transaminases, or urine
analysis.
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Nefopam
has retention times similar
to codeine, diazepam,
and pentazocine in some
chromatographic analyses
and may interfere with
assays. |
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| OVERDOSAGE: |
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Symptoms of
overdosage may include convulsions,
agitation, hallucinations,
and tachycardia. Treatment
of overdosage is supportive,
with the administration of
diazepam for agitation and
convulsions, and possibly
ß-adrenoreceptor blockade
fortachyarrythmias.
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| HIGH RISK GROUPS: |
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Neonates:
Nopain is not recommended
for use in neonates, as
no data are available.
Nefopam is excreted in
breast milk, but the effects
on children of nursing
mothers are unknown.
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Children:
No dose recommendations
are available for children
under 12 years of age.
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Pregnant
Women: No data
are available regarding
the use of nefopam in
pregnancy. Although use
of Nopain in labour is
unlikely to cause neonatal
respiratory depression,
no studies have been reported.
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The
Elderly: It is
advisable to start treatment
with a lower dose. |
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| STORAGE: |
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Keep at a temperature
not exceeding 30 °C, out
of reach of children.
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| HOW SUPPLIED: |
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Box of 3 ampoules,
each contains 20 mg Nefopam
HCI in 1 ml.
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