DILANTIN 125

Nazione: Israele

Lingua: inglese

Fonte: Ministry of Health

Principio attivo:

PHENYTOIN

Commercializzato da:

PFIZER PFE PHARMACEUTICALS ISRAEL LTD

Codice ATC:

N03AB02

Forma farmaceutica:

SUSPENSION

Composizione:

PHENYTOIN 125 MG / 5 ML

Via di somministrazione:

PER OS

Tipo di ricetta:

Required

Prodotto da:

PHARMACIA & UPJOHN COMPANY LLC, USA

Gruppo terapeutico:

PHENYTOIN

Area terapeutica:

PHENYTOIN

Indicazioni terapeutiche:

For the control of tonic clonic (Grand- mal) and psychomotor (Temporal lobe seizures).

Data dell'autorizzazione:

2021-11-30

Foglio illustrativo

Dilantin 125, Suspension PIL CC Technical change 08 May 2022 English
2022-0078210
1
_ _
PATIENT LEAFLET IN ACCORDANCE WITH THE
PHARMACISTS’ REGULATIONS (PREPARATIONS) - 1986
This medicine is dispensed with a doctor’s prescription only
DILANTIN
® 125
SUSPENSION
EACH 5 ML OF SUSPENSION CONTAINS: PHENYTOIN 125 MG
Inactive ingredients and allergens: See section 2 under ‘Important
information about some of this
medicine’s ingredients’ and section 6 “Further information”.
READ THE ENTIRE LEAFLET CAREFULLY BEFORE USING THE MEDICINE. This
leaflet contains concise
information about this medicine. If you have any further questions,
consult your doctor or pharmacist.
This medicine has been prescribed for you. Do not pass it on to
others. It may harm them, even if it
seems to you that their medical condition is similar to yours.
1. WHAT IS THIS MEDICINE INTENDED FOR?
For treatment of tonic-clonic (grand mal) and psychomotor (temporal
lobe) seizures.
THERAPEUTIC GROUP: anticonvulsant.
2.
BEFORE USING THIS MEDICINE DO NOT USE THIS MEDICINE IF:
•
you are sensitive (allergic) to the active ingredient or to any of the
other ingredients contained
in the medicine (see section 6) or to medicines of the hydantoin
group, including
hypersensitivity reaction such as angioedema.
•
you have suffered in the past from liver problems due to taking
phenytoin.
•
you are taking delavirdine
.
SPECIAL WARNINGS REGARDING USE OF THE MEDICINE
BEFORE TREATMENT WITH DILANTIN, TELL YOUR DOCTOR IF:
•
You are suffering or have suffered from depression, mood swings,
suicidal thoughts or behavior.
•
You have experienced in the past an allergic reaction to medicines
similar to Dilantin, such as
carboxamides, barbiturates, succinimides and oxazolidinediones.
•
You are suffering or have suffered from liver or kidney problems.
•
You are suffering or have suffered from porphyria.
•
You are suffering or have suffered from high blood sugar levels
(hyperglycemia).
•
You consume alcohol.
•
You are pregnant or planning to become pr

Scheda tecnica

Dilantin 125, Suspension
LPD CC Technical change 08 May
2022
1
2022–0078210
DILANTIN
® 125
NAME OF THE MEDICINAL PRODUCT
DILANTIN
®
125
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 5 ml of suspension contains 125 mg of phenytoin
Excipients with known effect:
For the full list of excipients, see section
_Description (11)_
in this leaflet.
PHARMACEUTICAL FORM
Oral suspension
.
1
THERAPEUTIC INDICATIONS
Dilantin (phenytoin) is indicated for the control of tonic-clonic
(grand mal) and psychomotor (temporal lobe)
seizures.
Phenytoin serum level determinations may be necessary for optimal
dosage adjustments (see DOSAGE AND
ADMINISTRATION and CLINICAL PHARMACOLOGY sections).
2
DOSAGE AND ADMINISTRATION
FOR ORAL ADMINISTRATION 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. The free acid form of phenytoin is used in
Dilantin-125/5ml Suspension. Because there
is approximately an 8% increase in drug content with the free acid
form over that of the sodium salt, dosage
adjustments and serum level monitoring may be necessary when switching
from a product formulated with the
free acid to a product formulated with the sodium salt and vice versa.
GENERAL:
Dosage should be individualized to provide maximum benefit. In some
cases serum blood level
determinations may be necessary for optimal dosage adjustments—the
clinically effective serum level is usually
10–20 mcg/mL although some mild cases of tonic-clonic (grand mal)
epilepsy may be controlled with lower
serum levels of phenytoin. With recommended dosage, a period of seven
to ten days may be required to achieve
steady-state blood levels with phenytoin and changes in dosage
(increase or decrease) should not be carried out
at intervals shorter than seven to ten days.
ADULT DOSE:
Patients who have received no previous treatment may be started on one
teaspoonful (5 mL) of
Dilantin-125/5ml Suspension three times daily, and the dose is then
adjusted to suit in