Lotemp Kids Suspension 120mg5ml

Country: Malaysia

Bahasa: Inggeris

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

Bahan aktif:

PARACETAMOL/ACETAMINOPHEN

Boleh didapati daripada:

MEDISPEC (M) SDN.BHD

INN (Nama Antarabangsa):

PARACETAMOL/ACETAMINOPHEN

Unit dalam pakej:

60 ml

Dikeluarkan oleh:

Biolab Co., Ltd

Risalah maklumat

LOTEMP KIDS SUSPENSION 120MG/5ML
Paracetamol (120 mg/5ml)
1
_ CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_
WHAT IS IN THIS LEAFLET
1.
What
_Lotemp Kids_
is used for
2.
How
_Lotemp Kids_
works
3.
Before you use
_Lotemp Kids_
4.
How to use
_Lotemp Kids_
5.
While you are using it
6.
Side effects
7.
Storage
and
Disposal
of
_Lotemp _
_Kids_
8.
Product Description
9.
Manufacturer
and
Product
Registration Holder
10.
Date of revision
WHAT _LOTEMP KIDS_ IS USED FOR
Relieves fever, aches and pain of flu,
discomfort
of
teething
and
fever
after
vaccination.
HOW _LOTEMP KIDS_ WORKS
_Lotemp Kids _
contain a medicine called
paracetamol
(acetaminophen).
This
belongs to a group of medicines called
analgesics (pain-killer) and antipyretics
(reduce fever). It works by relieving pain
and reducing high temperature and fever.
BEFORE YOU USE _LOTEMP KIDS_
_-When you must not use it _
Do not use
_Lotemp Kids_
if:
•
Your child is allergic to paracetamol
or any of the other ingredients of
_Lotemp Kids_
•
Your
child
is
taking
any
other
products that contain Paracetamol
_ _
_Pregnancy and lactation _
Do
not
take
_Lotemp _
_Kids _
if
you
are
pregnant, trying to get pregnant or think
you may be pregnant.
Do
not
take
_Lotemp _
_Kids _
if
you
are
breast-feeding.
Ask
your
doctor
or
pharmacist for advice before taking any
medicine.
_ _
-
_Before you start to use it _
Talk to your child’s doctor before using
_Lotemp Kids _
if:
•
Your child is allergic to paracetamol
or any of the other ingredients of
_Lotemp Kids Suspension_
.
•
You have alcoholic liver disease
•
You
have
glucose
6-phosphate
dehydrogenase deficiency
-
_Taking other medicines _
Tell your doctor or pharmacist if you are
taking, have recently taken, or might take
any other medicines including medicines
obtained without a prescription.
Tell your doctor if you are taking the
following medicines, before starting to
use
_Lotemp Kids_
:
•
Barbiturates (a type of sedative)
•
Activated
charcoal
(used
to
treat
drug overdose or poisoning)
•
Hydantoins (used to treat seiz

Ciri produk

1
LOTEMP KIDS SUSPENSION 120 MG/5ML
NAME AND STRENGTH OF ACTIVE SUBSTANCE
Paracetamol 120mg/5ml
PRODUCT DESCRIPTION
Light purple with bubblegum flavor suspension.
PHARMACODYNAMICS
Pharmacological actions:
Acetaminophen is the active metabolic of phenacetin and has
antipyretic and analgesic activities. In
peripheral tissue, acetaminophen is a weak COX-1 and COX-2 inhibitor.
Acetaminophen appears to an
equivalent to aspirin as an analgesic and antipyretic agent. However,
acetaminophen lacks anti-
inflammatory properties, does not affect uric acid levels and does not
inhibit platelet function.
PHARMACOKINETICS
_Absorption/Distribution _
Immediate-release acetaminophen is absorbed rapidly, and peak plasma
levels are reached in 30 to
60 minutes. Acetaminophen is distributed throughout most body fluids
and is slightly bound to plasma
proteins.
_Metabolism/Distribution _
Approximately 90% of acetaminophen usually undergoes hepatic
conjugation with glucuronide (40%
to 67%) and sulfate (20% to 46%) to from inactive metabolites that are
excreted in the urine. A small
amout (5% to 15%) of acetaminophen is metabolized to
N-acetyl-p-benzoquinoneimine (NAPQI), and
the resulting complex is rendered harmless and excreted. After a large
ingestion of acetaminophen,
these
pathways
become
satured,
and
glutathione
stores
become
depleted.
Therefore,
NAPQI
concentrations increase, which may cause hepatotoxicity. The
elimination half-life of acetaminophen
is about 2 to 3 hours. Less than 5% of acetaminophen is excreted
unchanged.
Special populations
Hepatic function impairment: the half-life may increase 2 fold or more
in patients with liver disease.
INDICATION
Relieves fever, aches and pain of flu, discomfort of teething and
fever after vaccination.
RECOMMENDED DOSAGE
- Maximum daily dose: 60 mg /kg presented in divided doses of 10 - 15
mg/kg throughout the 24
hour period.
- Minimum dosing interval: 4 hours
- No more than four doses in any 24-hour period. Do not exceed the
stated dose.
- The lowest dose necessary to achieve efficacy sh