UNIHIST SYRUP

国: マレーシア

言語: 英語

ソース: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

有効成分:

BROMPHENIRAMINE MALEATE; PHENYLEPHRINE HYDROCHLORIDE

から入手可能:

MEDISPEC (M) SDN.BHD

INN（国際名）:

BROMPHENIRAMINE MALEATE; PHENYLEPHRINE HYDROCHLORIDE

パッケージ内のユニット:

100 ml

製:

Unison Laboratories Co. Ltd.

情報リーフレット

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_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP) _
UNIHIST SYRUP
_ _
Brompheniramine maleate 4 mg ; Phenylephrine hydrochloride 10 mg
Page no. 1
WHAT IS IN THIS LEAFLET
1.
What UNIHIST is used for
2.
How UNIHIST works
3.
Before you use UNIHIST
4.
How to use UNIHIST
5.
While you are using it
6.
Side effects
7.
Storage and Disposal of UNIHIST
8.
Product Description
9.
Manufacturer and Product
Registration Holder
10. Date of revision
WHAT UNIHIST IS USED FOR
For the symptomatic relief of nasal
congestion due to cough and cold and
allergic
conditions,
mainly
rhinitis
[inflammation of the nasal mucous
membranes].
HOW UNIHIST WORKS
_ _
Brompheniramine/
phenylephrine
is
an
antihistamine
and
decongestant
combination.
The
antihistamine
works
by
blocking
the
action
of
histamine,
which
helps
reduce
symptoms such as watery eyes and
sneezing. The decongestant promotes
sinus
and
nasal
drainage,
which
relieves congestion and pressure.
BEFORE YOU USE UNIHIST
_-When you must not use it _
_ _

If you are allergic (hypersensitive)
to
Brompheniramine
or
Phenylephrine or to any other drugs
of similar chemical structure.

If you are allergic (hypersensitive)
to
any
of
the
other
ingredients
of
UNIHIST.

If you are pregnant and breast-
feeding

UNIHIST should be used only if
the
potential
benefit
to
the
patient
outweighs
the
possible
risk to the fetus.

UNIHIST should be used only if
the
potential
benefit
to
the
patient
outweighs
the
possible
risk to the infant.
Do not use this medicine if any of the
above applies to you. If you are not
sure, get advice from your doctor or
pharmacist before taking UNIHIST.
_-Before you start to use it _
_ _
Inform your doctor in cases of:

Liver or kidney problems

Epilepsy

Severe
hyperthyroidism
(pathologically
excessive
production of thyroid hormones)

Severe ischemic heart disease

Diabetes
mellitus
or
prostatic
hyperplasia
[nonmalignant
(noncancerous) enlargement of the
prostate
gland,
a
common
occurrence
in
older
men]
should
also av

製品の特徴

FRONT
BACK
13 cm.
19 cm.
ANTIHISTAMINE (H1-RECEPTOR)/ DECONGESTANT
Each 5 mL contains:
BROMPHENIRAMINE MALEATE 4 MG
PHENYLEPHRINE HYDROCHLORIDE 10 MG
PRODUCT DESCRIPTION:
Clear, purple syrup with grape flavor
MECHANISM OF ACTION
:
@
_PHARMACOLOGY_
Antihistaminic (H
1
-receptor): Antihistamines used in the treatment of allergy act by
competing with histamine
for H
1
-receptor sites on effector cells. They thereby prevent, but do not
reverse, responses mediated by histamine alone.
The anticholinergic actions of most antihistamines provide a drying
effect on the nasal and oral mucosa.
Decongestant: Sympathomimetic amines act on alpha-adrenergic receptors
in the mucosa of the respiratory tract
to produce vasoconstriction, which temporarily reduces the swelling
associated with inflammation of the mucous
membranes lining the nasal passages.
_PHARMACOKINETICS_
Absorption: Phenylephrine has reduced bioavailability (about 38%) from
gastrointestinal tract because of first pass
metabolism by monoamine oxidase in the stomach and liver.
Biotransformation: Antihistamines - Hepatic (cytochrome P-450 system);
some renal;
Sympathomimetic amines – Phenylephrine: Extensive in the intestinal
wall and in the liver. Sulfate conjugates are
formed largely in the intestinal wall. Also, undergoes oxidative
deamination by monoamine oxidase.
Half-life: Brompheniramine - 25 hours; Phenylephrine - 2.1 to 3.4
hours.
Onset of action: Most first generation antihistamines: 15 to 60
minutes.
Time to peak concentration: Brompheniramine - 2 to 5 hours;
Phenylephrine - 0.75 to 2 hours (to achieve peak
levels ranging from 0.9 to 298 ng/mL, respectively).
Time to peak effect: Brompheniramine - 3 to 9 hours;
Elimination: Antihistamines - Renal. Most of the antihistamines
studied are excreted as metabolites within 24 hours;
Phenylephrine: 2.6% of the administered oral dose is excreted
unchanged; 80 to 86% of unchanged Phenylephrine
and metabolites are recovered in 48 hours after oral administration.
INDICATION:
For the symptomatic relief of nasal conge