DBL PHENYTOIN INJECTION 250mg/5mL ampoule

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

phenytoin sodium, Quantity: 250 mg

Available from:

Pfizer Australia Pty Ltd

Pharmaceutical form:

Injection, solution

Composition:

Excipient Ingredients: propylene glycol; water for injections; hydrochloric acid; sodium hydroxide; ethanol absolute

Administration route:

Intravenous

Units in package:

5 x 5mL

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

For the control of status epilepticus, tonic-clonic (grand mal), psychomotor seizures and the prevention of seizures occurring during or following neurosurgery. Phenytoin 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, phenytoin frequently improves the mental condition and outlook of epileptic patients. It has also been used in the treatment of certain cardiac arrhythmias, particularly in those patients who do not respond to conventional antiarrhythmic agents or to cardioversion. Phenytoin serum level determinations may be necessary for optimal dosage adjustments (see DOSAGE AND ADMINISTRATION)

Product summary:

Visual Identification: Clear, colourless solution, free from visible particulates.; Container Type: Ampoule; Container Material: Glass Type I Clear; Container Life Time: 18 Months; Container Temperature: Store below 25 degrees Celsius

Authorization status:

Registered

Authorization date:

1993-11-30

Patient Information leaflet

DBL™ PHENYTOIN INJECTION BP
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CONSUMER MEDICINE INFORMATION (CMI) SUMMARY
The full CMI on the next page has more details. If you are worried
about using this medicine, speak to your doctor or pharmacist.
1.
WHY AM I BEING TREATED WITH DBL PHENYTOIN INJECTION BP?
DBL Phenytoin Injection BP contains the active ingredient phenytoin.
DBL Phenytoin Injection BP is used to control epilepsy. It can
also be used to prevent seizures during or after brain surgery and to
treat a rapid or irregular heartbeat.
For more information, see Section 1. Why am I being treated with DBL
Phenytoin Injection BP? in the full CMI.
2.
WHAT SHOULD I KNOW BEFORE TREATMENT WITH DBL PHENYTOIN INJECTION BP?
Do not start treatment if you have ever had an allergic reaction to
phenytoin, or to a group of medicines called hydantoins or any of
the ingredients listed at the end of the CMI.
TALK TO YOUR DOCTOR IF YOU HAVE ANY OTHER MEDICAL CONDITIONS, TAKE ANY
OTHER MEDICINES, OR ARE PREGNANT OR PLAN TO BECOME
PREGNANT OR ARE BREASTFEEDING.
For more information, see Section 2. What should I know before
treatment with DBL Phenytoin Injection BP? in the full CMI.
3.
WHAT IF I AM TAKING OTHER MEDICINES?
Some medicines may interfere with DBL Phenytoin Injection BP and
affect how it works.
A list of these medicines is in Section 3. What if I am taking other
medicines? in the full CMI.
4.
HOW IS DBL PHENYTOIN INJECTION BP GIVEN?
Your doctor will decide what dose you will receive. This depends on
your condition and other factors, such as your weight. DBL
Phenytoin Injection BP is given as a slow injection into a vein. It
must only be given by a doctor or nurse.
More instructions can be found in Section 4. How is DBL Phenytoin
Injection BP given? in the full CMI.
5.
WHAT SHOULD I KNOW DURING TREATMENT WITH DBL PHENYTOIN INJECTION BP?
THINGS YOU
SHOULD DO
•
Call your doctor straight away if you notice any of the following:
increase in seizures (fits), yellowing
of the skin and/or eyes, swelling of the face, s

Summary of Product characteristics

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AUSTRALIAN
PRODUCT
INFORMATION
–
DBL™ PHENYTOIN INJECTION BP (PHENYTOIN
SODIUM)
1.
NAME OF THE MEDICINE
Phenytoin sodium
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
DBL Phenytoin Injection BP is a ready mixed solution of Phenytoin
Sodium.
Each mL of solution contains phenytoin sodium 50mg, propylene glycol
0.4 mL and ethanol
absolute 0.1 mL in Water for Injections, adjusted to pH 12 with either
sodium hydroxide or
hydrochloric acid.
EXCIPIENT(S) WITH KNOWN EFFECT
Alcohol
For the full list of excipients, see 6.1 LIST OF EXCIPIENTS.
3.
PHARMACEUTICAL FORM
DBL Phenytoin Injection BP is a clear, colourless solution, free from
visible particulates.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
For the control of status epilepticus, tonic-clonic (grand mal),
psychomotor seizures and the
prevention of seizures occurring during or following neurosurgery.
Phenytoin 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, phenytoin frequently improves
the mental condition and
outlook of epileptic patients.
It has also been used in the treatment of certain cardiac arrhythmias,
particularly in those
patients who do not respond to conventional antiarrhythmic agents or
to cardioversion.
Phenytoin serum level determinations may be necessary for optimal
dosage adjustments (see
4.2 DOSE AND METHOD OF ADMINISTRATION).
4.2
DOSE AND METHOD OF ADMINISTRATION
DOSAGE
_Status epilepticus:_
For the control of status epilepticus in adults, a loading dose of 10
to 15
mg/kg should be administered slowly intravenously, at a rate not
exceeding 50 mg/min. This
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will require approximately 20 minutes in a 70 kg patient. The loading
dose should be followed
by maintenance doses of 100 mg orally or intravenously every 6 to 8
hours.
For