NAUSICALM TABLET 50MG

Država: Singapur

Jezik: angleščina

Source: HSA (Health Sciences Authority)

Aktivna sestavina:

Cyclizine hydrochloride

Dostopno od:

APEX PHARMA MARKETING PTE. LTD.

Koda artikla:

R06AE03

Farmacevtska oblika:

TABLET

Sestava:

Cyclizine hydrochloride 50mg

Pot uporabe:

ORAL

Tip zastaranja:

Prescription Only

Izdeluje:

Sigma Laboratories Ltd.

Status dovoljenje:

ACTIVE

Datum dovoljenje:

2017-03-20

Lastnosti izdelka

PRODUCT INFORMATION
NAUSICALM
Cyclizine hydrochloride 50 mg tablets.
NAME OF THE MEDICINE
Cyclizine hydrochloride.
Cyclizine hydrochloride has the following chemical structure:
It has the chemical formula C
18
H
22
N
2
.HCl with a molecular weight of 302.84. The CAS
number is 82-92-8.
DESCRIPTION
Cyclizine hydrochloride is a white to almost white crystalline powder.
It is slightly soluble in
water and in ethanol (96%).
Nausicalm tablets contain 50 mg of cyclizine hydrochloride.
Nausicalm tablets also contain potato starch, lactose monohydrate, gum
acacia, and
magnesium stearate.
PHARMACOLOGY
Cyclizine is a piperazine derivative with the general properties of H
1
-blocking drugs but is
used as an anti-emetic in a variety of clinical situations including
drug-induced and motion
sickness, vertigo, post-operative vomiting and radiation sickness. The
mechanism of the anti-
emetic effect is unclear. Cyclizine also possesses anticholinergic
activity but does not have
marked sedative effects
.
PHARMACOKINETICS
The bioavailability of Nausicalm tablets is approximately 40%.
In fasted, healthy male subjects given an oral dose of one single 50
mg Nausicalm tablet,
peak plasma concentration of cyclizine was 15 ± 10 ng/mL, with a T
max
of 4 ± 2 hours,
AUC
0-inf
of 409 ± 196 ng.hr/mL, and elimination half-life of 26 ± 7 hours.
HCl
Cyclizine is extensively N-demethylated to the largely inactive
metabolite norcyclizine,
which is widely distributed throughout the tissues and has a plasma
half-life of less than one
day.
INDICATIONS
Nausicalm is indicated for the prevention and treatment of nausea and
vomiting
associated with motion sickness and radiotherapy.
CONTRAINDICATIONS
Nausicalm should not be given to individuals with known
hypersensitivity to cyclizine or in
individuals with severe heart failure.
WARNINGS AND PRECAUTIONS
_USE IN CHILDREN_
Not recommended for use in children 12 years and under.
_USE IN THE ELDERLY_
There have been no specific studies of cyclizine in the elderly.
Experience has indicated that
normal adult