Dilantin Oral Suspension 125mg/5ml

Country: Malaysia

Bahasa: Inggeris

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

Bahan aktif:

PHENYTOIN SODIUM

Boleh didapati daripada:

PFIZER (MALAYSIA) SDN. BHD.

INN (Nama Antarabangsa):

PHENYTOIN SODIUM

Unit dalam pakej:

237 ml

Dikeluarkan oleh:

PHARMACIA & UPJOHN CO

Risalah maklumat

Pfizer Confidential
_ _
_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_
_ _
1
PIL TITLE
: DILANTIN ORAL SUSPENSION
PIL DATE
: 06 September 2018
COUNTRY
: Malaysia
REFERENCES
: 125 mg/5 mL Dilantin Oral Suspension of Malaysia LPD dated 21
September 2015
REASON
: To align with current effective LPD.
To add Serial Number.
Pfizer Confidential
_ _
_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_
_ _
DILANTIN ORAL SUSPENSION
Phenytoin (125 mg/5 mL)
2
WHAT IS IN THIS LEAFLET
1.
What DILANTIN ORAL
SUSPENSION is used for
2.
How DILANTIN ORAL
SUSPENSION works
3.
Before you use DILANTIN
ORAL SUSPENSION
4.
How to use DILANTIN ORAL
SUSPENSION
5.
While you are using it
6.
Side Effects
7.
Storage and Disposal of
DILANTIN ORAL
SUSPENSION
8.
Product Description
9.
Manufacturer
10.
Product Registration Holder
11.
Date of Revision
12.
Serial Number
WHAT DILANTIN ORAL
SUSPENSION IS USED FOR
DILANTIN ORAL SUSPENSION is
used to control epilepsy. Epilepsy is a
condition where you have repeated
seizures (fits). There are many
different types of seizures, ranging
from mild to severe.
HOW DILANTIN ORAL
SUSPENSION WORKS
DILANTIN ORAL SUSPENSION
belongs to a group of medicines
called anticonvulsants. These drugs
are thought to work by controlling
brain chemicals, which send signals
to nerves so that seizures do not
happen.
BEFORE YOU USE DILANTIN ORAL
SUSPENSION
_- When you must not use it _
DO NOT TAKE DILANTIN
ORAL
SUSPENSION
-
if you have a history of allergy to
Phenytoin or to the inactive
ingredients of DILANTIN ORAL
SUSPENSION or other hydantoin
medicines;
-
if you are taking Delavirdine (used
in the treatment of HIV infection).
_ _
_Pregnancy and lactation _
DILANTIN ORAL SUSPENSION
may affect your developing baby if
you take it during pregnancy.
However, it is very important to
control your fits while you are
pregnant. If it is necessary for you to
take DILANTIN ORAL
SUSPENSION, your doctor can help
you decide whether or not to take it
during pregnancy.
Tell your doctor if you are
breastfeeding or intend to breastfeed.
It is not

Ciri produk

Pfizer Confidential Page 1 of 14 LPD Title: Phenytoin LPD Date: 18 October 21 September 201 65 Country: Malaysia Reference : USPI Dated May 2016 July 2015 ,; CDS Version 13.0 9.0 Dated 15 June 2016 23 April 2014 Reason: Addition of statement regarding hyperbilirubinemia in section 4.4 of the CDS. Changes regarding non -epilepsy indications in the phenytoin CDS. Updates regarding cerebellar atrophy. Add statement to pregnancy section: phenytoin crosses placenta. Addition o f information related to dosing in special populations, patients with renal or hepatic disease and in the elderly in section s 4.2 and 5.2 of the CDS. Remove mention of "Kapseals" from Dilantin Oral Suspension, Dilantin Infatabs, Greenstone Oral Suspen sion, Greenstone Infatabs USPIs, as this proprietary capsule is no longer used. The Dilantin USPIs are being updated to add blurred vision in overdosage section of the USPI, to align with the CDS. This pfleet record applies only to Dilantin Infatabs and Oral Suspension (active ingredient phenytoin). Separate pfleet records are being created for Injection and Capsules (phenytoin sodium, 2015 -0010891) and for the Greenstone Infatabs and Oral Suspension labels (2015 -0011341).
1.0 NAME OF MEDICINAL PR ODUCT
Dila ntin Oral Suspension 125 mg/5 mL.
2.0 QUALITATIVE AND QUAN TITATIVE COMPOSITION Each 5 mL of suspension contains 125 mg phenytoin, USP.
3.0 PHARMACEUTICAL FORM Phenytoin Oral Suspension 125 mg/5 mL will be provided as an opaque orange suspension with an orange –vanilla -banana odor. The drug product is packaged in a round amber glass bottle,
having a polypropylene cap.
4.0 CLINICAL PARTICULARS
4.1 Therapeutic Indications Phenytoin is indicated for the control of tonic -clonic (grand mal) and ps ychomotor (temporal
lobe) seizures.
4.2 Posology and Method of Administration For oral administratio n only; not for parenteral use. Serum concentrations should be monitored and care should be taken when switching a patient
from the sodium salt to the free acid form. Dilantin extended capsules are �