DILANTIN PAEDIATRIC SUSPENSION phenytoin 30mg/5mL oral liquid bottle

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

phenytoin, Quantity: 6 mg/mL

Available from:

Viatris Pty Ltd

Pharmaceutical form:

Oral Liquid, suspension

Composition:

Excipient Ingredients: sodium benzoate; polysorbate 40; citric acid monohydrate; glycerol; purified water; carmellose sodium; ethanol; vanillin; carmoisine; sucrose; sunset yellow FCF; aluminium magnesium silicate; Flavour

Administration route:

Oral

Units in package:

1 x 500mL bottle

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

DILANTIN is indicated for the control of grand mal and psychomotor seizures. DILANTIN will prevent or effectively decrease the incidence and severity of convulsive seizures in a high percentage of cases, with patients exhibiting little tendency to become resistant to its action. Besides its effectiveness in controlling seizures, DILANTIN frequently improves the mental condition and outlook of epileptic patients and there is also increasing evidence that DILANTIN is valuable in the prevention of seizures occurring during or after neurosurgery and in the treatment of certain cardiac arrythmias. Phenytoin serum level determinations may be necessary for optimal dosage adjustments (see Dosage and Administration).

Product summary:

Visual Identification: Viscous, cherry-red suspension with a characteristic odour of banana and orange.; Container Type: Bottle; Container Material: Glass Type III Coloured; Container Life Time: 3 Years; Container Temperature: Store below 25 degrees Celsius; Container Closure: Child resistant closure

Authorization status:

Registered

Authorization date:

1991-09-20

Patient Information leaflet

DILANTIN
®
_phenytoin, phenytoin sodium_
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about Dilantin.
It does not contain all the available
information.
It does not take the place of talking to
your doctor or pharmacist.
All medicines have risks and
benefits. Your doctor has weighed
the risks of you taking Dilantin
against the benefits they expect it
will have for you.
IF YOU HAVE ANY CONCERNS ABOUT
TAKING THIS MEDICINE, ASK YOUR
DOCTOR OR PHARMACIST.
KEEP THIS LEAFLET WITH THE MEDICINE.
You may need to read it again.
WHAT DILANTIN IS USED
FOR
Dilantin 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.
Dilantin 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.
Dilantin is also used to help prevent
seizures occurring during or after
brain surgery.
Dilantin may be used alone, or in
combination with other medicines, to
treat your condition.
Your doctor may have prescribed
Dilantin for another reason. Ask your
doctor if you have any questions
about why Dilantin has been
prescribed for you.
There is no evidence that Dilantin is
addictive.
This medicine is available only with
a doctor's prescription.
BEFORE YOU TAKE
DILANTIN
_WHEN YOU MUST NOT TAKE IT_
DO NOT TAKE DILANTIN IF YOU HAVE AN
ALLERGY TO:
•
phenytoin sodium or phenytoin,
the active ingredients in Dilantin,
or other hydantoin medicines or
any of the ingredients listed at the
end of this leaflet
•
methylphenobarbitone or any
other barbiturate medicines
•
other medicines used to treat fits
and convulsions.
Symptoms of an allergic reaction to
Dilantin may include:
•
shortness of breath, wheezing or
difficulty breathing
•
swelling of the face, lips, tongue
or other parts of the body
•
rash, itching or hives on the skin.
DO NOT TAKE THIS MEDICINE IF YOU
ARE T

Summary of Product characteristics

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AUSTRALIAN PRODUCT
INFORMATION -
DILANTIN
 (PHENYTOIN SODIUM/
PHENYTOIN)
1. NAME OF THE MEDICINE
Phenytoin sodium
Phenytoin
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Dilantin
®
30 mg capsules: each 30 mg capsule contains 30 mg phenytoin sodium.
Dilantin
®
100 mg capsules: each 100 mg capsule contains 100 mg phenytoin sodium.
Dilantin
®
Infatabs 50 mg chewable tablets: each 50 mg chewable infatab contains
50 mg
phenytoin.
Dilantin
®
30 mg/5 mL paediatric oral suspension: each 5 mL of paediatric
suspension contains
30 mg phenytoin.
Phenytoin is a white, or almost white, odourless or almost odourless,
crystalline powder. It is
practically insoluble in water and soluble 1 in 70 alcohol.
Phenytoin sodium is the sodium salt of phenytoin. It is a white,
odourless, slightly hygroscopic
crystalline powder. It is soluble in water and alcohol.
EXCIPIENTS WITH KNOWN EFFECT:
All formulations contain sucrose.
The 30 mg capsule new formulation (AUST R 295264) contains lactose
monohydrate.
The 100 mg capsule (both old and new formulations AUST R 14305 and
AUST R 295265)
contains lactose monohydrate.
For the full list of excipients, see section 6.1 List of excipients.
3. PHARMACEUTICAL FORM
Capsules 30 mg: opaque hard gelatin capsule with white body/white lid,
marked ‘PARKE
DAVIS’ on one end and ‘P-D 30’ on the other.
Capsules 100 mg: opaque hard gelatin capsule with white body/orange
lid, marked ‘PARKE
DAVIS’ on one end and ‘P-D 100’ on the other.
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Infatabs 50 mg: yellow, triangular, spearmint-flavoured chewable
tablets with flat sides,
bevelled edge, breaking line on one side and ‘P-D 007’ imprinted
on the other.
Paediatric suspension: reddish-pink suspension.
4. CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Dilantin is indicated for the control of generalised tonic-clonic
(grand mal) and psychomotor
seizures. Dilantin will prevent or effectively decrease the incidence
and se