Lorastad 10 Tablets

Maa: Malesia

Kieli: englanti

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

Aktiivinen ainesosa:

LORATADINE

Saatavilla:

STADPHARM SDN. BHD.

INN (Kansainvälinen yleisnimi):

LORATADINE

Kpl paketissa:

100 Tablets; 20Tablet Tablets

Valmistaja:

STELLAPHARM J.V. Co., LTD. - BRANCH 1

Pakkausseloste

LORASTAD 10 TABLETS
Active ingredient: Loratadine (10mg)
_ _
Page no. 1
_ Consumer Medication Information Leaflet (RiMUP)_
_ _
WHAT IS IN THIS LEAFLET
1.
What Lorastad 10 Tablets is
used for.
2.
How Lorastad 10 Tablets
works.
3.
Before you use Lorastad 10
Tablets.
4.
How to use Lorastad 10 Tablets.
5.
While you are using Lorastad
10 Tablets.
6.
Side effects.
7.
Storage and disposal of
Lorastad 10 Tablets.
8.
Product description.
9.
Manufacturer and Product
Registration Holder.
10.
Date of revision.
WHAT LORASTAD 10 TABLETS IS USED
FOR
Lorastad 10 Tablets is used to
relieve symptoms associated with
an allergic inflammation of the
nasal airways occuring during
specific seasons (seasonal allergic
rhinitis) such as sneezing, watery
nose, itching as well as eye itching
and burning.
It is also used for the control of
symptoms and signs of idiopathic
chronic urticaria (a common
allergic disorder including red,
itchy, lumpy skin rash that occurs
year round and the cause of that is
not known or that arises
spontaneously) and other allergic
skin disorders.
HOW LORASTAD 10 TABLETS WORKS
Loratadine belongs to a class of
medicines known as antihistamines
which help to reduce allergic
symptoms by preventing the effects
of a substance called histamine,
which is produced in the body.
BEFORE YOU USE LORASTAD 10
TABLETS
_When you must not use it _
- If you have have shown
hypersensitivity or unusual and
unexpected sensitivity to any
components of Lorastad 10
Tablets
- Children under the age of 2 years.
_ _
_Before you start to use it _
If any of the situations mentioned
below apply to you, you should tell
your doctor before taking this drug:
- If you have severe liver problem,
you should take the medicine with
a lower initial dose.
- If you are pregnant women.
- If you are in breast-feeding.
_Taking other medicines _
Please tell your doctor or
pharmacist if you are taking, or
have recently taken any other
medicines, including medicines
obtained without a prescription
_. _
You should tell your doctor if you
are receiving other drug

Valmisteyhteenveto

_Active ingredient:_
_Other ingredients:_
Each tablet contains Loratadine 10 mg.
Human histamine skin wheal studies following single and repeated 10 mg
oral doses of Loratadine have shown that the drug
exhibits an antihistaminic effect beginning within 1 to 3 hours,
reaching a maximum at 8 to 12 hours, and lasting in excess of 24
hours. There was no evidence of tolerance to this effect after 28 days
of dosing with Loratadine.
PHARMACOLOGY
Whole body autoradiographic studies in rats and monkeys, radiolabeled
tissue distribution studies in mice and rats, and
_in vivo_
radioligand studies in mice have shown that neither Loratadine nor its
metabolites readily cross the blood-brain barrier. Radioligand
binding studies with guinea pig pulmonary and brain H1-receptors
indicate that there was preferential binding to peripheral
versus central nervous system H1-receptors.
Pharmacokinetic studies showed that Loratadine rapidly disintegrating
tablets provide plasma concentrations of Loratadine
descarboethoxyloratadine similar to those achieved with Loratadine
tablets. Following oral administration of 10 mg Loratadine
once daily for 10 days with each dosage forms in a randomized
crossover comparison in 24 normal adult subjects, similar mean
exposures (AUC) and peak plasma concentrations (Cmax) of Loratadine
were observed Loratadine rapidly disintegrating tablets
mean AUC and Cmax were 11% and 6% greater than that of the Loratadine
tablet values, respectively. Descarboethoxyloratadine
bioequivalence was demonstrated between the two formulations. After 10
days of dosing, mean peak plasma concentrations
were attained at 1.3 hours and 2.3 hours (Tmax) for parent and
metabolite, respectively.
Loratadine is a potent long acting tricyclic antihistamine with
selective peripheral H1-receptor antagonistic activity.
PHARMACOKINETICS
Repeated application of Loratadine rapidly disintegrating tablets to
the hamster cheek pouch did not cause local irritation.
Loratadine was rapidly absorbed following oral administration of 10 mg
tablets, on