Dilantin Oral Suspension 125mg5ml

País: Malásia

Língua: inglês

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

Ingredientes ativos:

PHENYTOIN SODIUM

Disponível em:

VIATRIS SDN. BHD.

DCI (Denominação Comum Internacional):

PHENYTOIN SODIUM

Unidades em pacote:

237 ml; 237 ml

Fabricado por:

PHARMACIA & UPJOHN CO

Folheto informativo - Bula

_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_
DILANTIN ORAL SUSPENSION
Phenytoin (125 mg/5 mL)
1
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 and Product
Registration Holder
10.
Date of Revision
11.
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.
Allergic reactions include a
condition called angioedema
which causes:
- swelling of the area beneath the
skin or mucosa
- if you have a history of liver
injury caused by phenytoin
- if you are taking delavirdine (used
in the treatment of HIV
infection).
_Pregnancy and lactation_
DILANTIN ORAL SUSPENSION
crosses the placenta and 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.
Your doctor may ask you
- to get serum phenytoin levels
checked.
- to take vitamin K before delivery
and give vitamin K to the new
born after birth.
Tell your doctor if you are
breastfeeding or intend to
breastfeed. It is not r

Características técnicas

Pfizer Confidential
LPD Title
: Phenytoin sodium (Dilantin oral suspension)
LPD Date
: 18023 NovemberMarchFebruary 20212022
Country
: Malaysia
Reference Documents
: USPI Dated February 17 March 20212022; CDS V 198.0 Dated 19 15 Oct
2018July2021
Reason for change
: PfLEET 2022-0076924 (O): PfLEET 2020-0065212 (S1): To update minor
administrative changes in the CLD Updates are being made to the USPI
to reflect
the potential risk of severe cutaneous adverse reactions (SCARs) in
patients who
are poor metabolizers of CYP2C9 substrates for phenytoin.
FORMATTED: Indent: Left: 0", Hanging: 1.5", Hyphenate,
Tab stops: Not at -1" + -0.5" + 0.39" + 0.59" + 1.58"
Pfizer Confidential
1
1.
NAME OF MEDICINAL PRODUCT
Dilantin Oral Suspension 125 mg/5 mL.
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 5 mL of suspension contains 125 mg phenytoin, USP.
3.
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.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Phenytoin is indicated for the control of tonic-clonic (grand mal) and
psychomotor (temporal
lobe) seizures.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
FOR ORAL ADMINISTRATION ONLY; NOT FOR PARENTERAL USE.
A calibrated measuring device is recommended to measure and deliver
the prescribed dose
accurately. A household teaspoon or tablespoon is not an adequate
measuring device.
ADULT DOSAGE:
The recommended starting dosage for adult patients who have received
no previous treatment is 5
mL (125 mg/5 mL), or one teaspoonful, by mouth three times daily.
Adjust the dosage to suit
individual requirements, up to a maximum of 25 mL daily (See
DOSAGE ADJUSTMENTS
).
PEDIATRIC DOSAGE:
The recommended starting dosage for pediatric patients is 5 mg/kg/day
by mouth in two or three
equally divided doses, with subsequent dosage individualized to a
maximum of 300 mg daily in
divided doses. A recommended daily maintenan