AURANTIN 250 mg /5 Ml Инъекционный Раствор

Содержание инструкции

1. AURANTIN 250 mg/5 ml injectable solution
   1. What is Aurantin and what is it used for
   2. What you need to know before Aurantin is administered
   3. How to administer Aurantin
   4. Possible side effects
   5. How to store Aurantin
   6. Contents of the pack and other information

AURANTIN 250 mg/5 ml injectable solution

Sodium phenytoin

Read this leaflet carefully before this medicine is administered as it contains
important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or the doctor caring for your child, or your nurse.
• If any side effects occur, including those not listed in this leaflet, ask your doctor or the doctor caring for your child, or your nurse. See section 4.

Contents of this leaflet:

• 1. What Aurantin is and what it is used for
• 2. What you need to know before Aurantin is administered
• 3. How to administer Aurantin
• 4. Possible side effects
• 5. How to store Aurantin
• 6. Contents of the pack and other information

1. What is Aurantin and what is it used for

Aurantin contains the active ingredient phenytoin sodium which belongs to a group of medicines called
antiepileptics used for the prevention and treatment of seizures, especially those caused by a
brain disease called epilepsy.
This medicine is indicated:

• for the treatment of status epilepticusof the tonic-clonic type (grand mal), characterized by a first phase in which the muscles suddenly stiffen and a second phase in which the muscles begin to contract and relax rapidly, causing convulsions;
• for the prevention and treatment of seizuresthat may occur during or after brain surgery (neurosurgical) and/or in cases of severe brain trauma;
• for the treatment of heart rhythm abnormalities (cardiac arrhythmias, such as life-threatening ventricular arrhythmias), when other therapies (first-line interventions) have proven ineffective and especially when these disorders (arrhythmias) are caused by medicines that increase the force of heart contraction (digitalis-based medicines).

2. What you need to know before Aurantin is administered

Aurantin must not be administered to you or your child:

• if you are allergic to sodium phenytoin, to other similar medicines (called hydantoins) or to any of the other components of this medicine (listed in section 6);
• via injection directly into an artery (endoarterial administration);
• if you suffer from a slowing of the heartbeat (sinus bradycardia);
• if you suffer from problems with heart activity (sinoatrial block, A-V block of second and third degree);
• if you are affected by a condition called Adams-Stokes syndrome, caused by heart problems and characterized by a sudden loss of consciousness, often accompanied by convulsions;
• if you are being treated with a medicine called delavirdine, used for the treatment of AIDS, as this medicine may lose its effectiveness. Generally contraindicated in pregnancy and breastfeeding (see section “Pregnancy and breastfeeding”).

Warnings and precautions
Consult your doctor or nurse beforeAurantin is administered to you or your child.

For control of convulsions, Aurantin must be administered to you or your child via
injection into a vein (intravenous route). Administration through a muscle (intramuscular route)
is not recommended because the effect of the medicine is slower. Aurantin must not be
administered to you or your child via other routes of administration (subcutaneous or
perivascular route).
Intramuscular administration of Aurantin can cause pain, abscess formation
and necrosis at the injection site.
In you or your child, this medicine may produce its effects more slowly than in
most people due to genetic reasons (polymorphism).
Tell your doctor or the doctor caring for your child if you think that any of the following conditions
applies to you or your child:

• you suffer from low blood pressure (hypotension);
• your heart is unable to supply adequate amounts of blood to the whole body (severe heart failure);
• you suffer from problems with liver function(reduced liver function) (see section “Use in people with liver problems”);
• you suffer from severe kidney problems(uremia) (see section “Use in people with severe kidney problems”);
• you suffer from diabetes, as an excessive increase in blood sugar levels (hyperglycemia) may occur.

Consult your doctor, the doctor caring for your child or the nurse if you or your child
develop the following conditions duringor aftertreatment with Aurantin (see also section 4
“Possible side effects”):

• suicidal thoughts. During therapy, the doctor will closely monitor you and your child. Immediately inform the doctor if you or your child have thoughts of harming yourself or committing suicide;
• serious heart problemssuch as cardiotoxic reactions, disturbances of the heartbeat (arrhythmias), reduction of the heart rate (bradycardia), depression of atrial and ventricular conduction, ventricular fibrillation, sometimes even fatal. These disorders occur especially in elderly and severely ill people. Heart problems have also occurred in adult and healthy children, and without any heart disease or concomitant disease, after administration of this medicine according to the instructions given in this leaflet (for example after administration of correct doses and using the recommended infusion rate). For these reasons, the doctor will carefully monitor the cardiac function (including respiratory function) of you or your child during the administration of Aurantin. If necessary, the doctor will take the necessary measures to avoid or minimize problems with your heart or that of your child, including reducing the dosage or stopping treatment.
• lowering of blood pressure(hypotension) if the medicine is administered via an injection into a vein (intravenous route), too quickly;
• irritation and inflammation at the injection siteand in some cases leakage of the medicine from the vein into which it was injected;
• purple glove syndromecharacterized by swelling due to fluid accumulation (edema), discoloration of the skin and pain even in areas far from the injection site, when the medicine is administered into a vein in the arm (peripheral injection). These disorders can occur several days after the injection. In more severe cases, tissue damage and death, skin breakdown may also occur, which may require surgery (fasciotomy, skin grafting, amputation of the arm);
• severe allergic reactions, such as hypersensitivity syndrome (HSS) or drug reaction with eosinophilia and systemic symptoms (DRESS) which can also be fatal. The symptoms of these disorders are: fever, skin irritation and/or enlargement of the lymph nodes (lymphadenopathy), inflammation of the liver (hepatitis), inflammation of the kidneys (nephritis), inflammation of the heart (myocarditis),

inflammation of the muscles (myositis), inflammation of the lungs (pneumonitis), blood problems
such as an increase in the number of white blood cells (leukocytosis, eosinophilia), joint pain
(arthralgia), enlargement of the liver (hepatomegaly), yellowing of the skin and eyes (jaundice). Stop
immediatelytreatment with Aurantin and inform your doctor or
the doctor caring for your child if you develop one or more of these symptoms, as
it is necessary to establish alternative therapy. These symptoms, which can occur from 2-4 weeks
to 3 months after the start of treatment, are more common in people of African origin, in people
who have already developed these syndromes in the past or who have a family member who suffers from them, and in
people with a severe reduction in the function of the immune system (immunocompromised);

• severe skin reactions, such as exfoliative dermatitis, Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN) which can also be fatal. If you or your child develop the following symptoms: skin irritation (rash, exanthems), blistering, mucous membrane lesions, inform your doctor immediatelywho will decide whether to stop treatment and establish alternative therapy. These effects can occur especially:
• during the first weeks of treatment
• in people of African or Asian origin (who may have positive HLA-B*1502 gene)
• if Aurantin is administered in conjunction with radiation therapy to the head or with corticosteroid medicines;
• severe liver problems(hepatotoxicity, liver damage, acute liver failure), sometimes also fatal and often associated with severe allergic reactions (HSS/DRESS syndromes). These disorders are more easily manifested in people of African origin, in people who already suffer from liver problems and in severely ill or elderly people. If you or your child develop liver damage, the doctor will permanently stop treatment with Aurantin;
• severe blood problems, such as a reduction in the number of platelets (thrombocytopenia), white blood cells (leukopenia, granulocytopenia, agranulocytosis) or all cells (pancytopenia) in the blood, which can also be fatal. These disorders can also be accompanied by a loss of bone marrow activity (bone marrow suppression). In some cases, an increase in the size and number of red blood cells (macrocytosis and megaloblastic anemia) may occur;
• enlargement of the lymph nodes(benign lymph node hyperplasia, pseudolymphoma, lymphoma and Hodgkin's disease) accompanied or not by the symptoms of a severe allergic reaction (HSS/DRESS syndromes). In this case, immediatelyinform your doctor or the doctor caring for your child, as several checks will be necessary and the doctor will decide whether to stop treatment and use alternative therapy;
• problems of the central nervous system(delirium, psychosis), encephalopathy, worsening of epileptic seizures and, in the most severe cases, irreversible brain damage (irreversible cerebellar dysfunction and/or cerebellar atrophy). If you or your child develop symptoms of brain toxicity, immediately inform the doctor who will prescribe specific tests and assess whether to stop therapy. Women of childbearing potential who are not planning a pregnancy must use effective contraceptive measures during treatment with Aurantin.

Duringtreatment with Aurantin, the intake of medicines based on Hypericum

perforatum(or St. John's Wort) ,used for the treatment of depression, must be avoided, as they reduce
the effectiveness of phenytoin (see section “Other medicines and Aurantin”).

Laboratory tests
During treatment with Aurantin, the doctor or the doctor caring for your child will perform careful and
regular checks of the levels of phenytoin in the blood, in order to be able to establish the most appropriate dose.
Inform your doctor or the doctor caring for your child if you suffer from severe kidney or liver problems,
as these problems may make it difficult to interpret the results of laboratory tests
that measure the levels of phenytoin in the blood.

Elderly patients
If you are over 65 years of age, your doctor may administer this medicine at a lower dose
than normally recommended or decrease the frequency of administrations.

Other medicines and Aurantin
Tell your doctor or the doctor caring for your child, or the nurse, if you or your child are
taking, have recently taken, or might take any other medicine.
You or your child will not be given Aurantin if you are already being treated with delavirdine, a
medicine used to treat AIDS (see section “Aurantin must not be given to you or your child”).
Tell your doctor if you or your child are taking the following medicines, as it may be
necessary to adjust the dose of Aurantin to be given.
Not all medicines are listed below. Talk to your doctor or pharmacist:

• painkillers and anti-inflammatory drugs(azapropazone, phenylbutazone, salicylates used to relieve pain and inflammation);
• anaesthetics(such as halothane used to induce anaesthesia during surgical procedures);
• antibacterials(chloramphenicol, erythromycin, isoniazid, sulfadiazine, sulfamethizole, sulfamethoxazole/trimethoprim, sulfafenazole, sulfisoxazole, sulfonamides, sultiamina, rifampicin, ciprofloxacin, tetracycline, doxycycline which prevent or block the growth of bacteria);
• other anticonvulsants(felbamate, oxcarbazepine, sodium valproate, succinimides, topiramate, vigabatrin, carbamazepine, phenobarbital, valproic acid, sodium valproate, lamotrigine used to treat seizures);
• antifungal agents(amphotericin B, fluconazole, itraconazole, ketoconazole, miconazole, voriconazole, posaconazole used to treat infections caused by fungi);
• antineoplastic agents(fluorouracil, capecitabine, bleomycin, carboplatin, cisplatin, doxorubicin, methotrexate, teniposide used for cancer therapy);
• benzodiazepines and psychotropic drugs(chlordiazepoxide, diazepam, disulfiram, methylphenidate, trazodone, viloxazine, phenothiazines used to treat certain mental disorders);
• calcium channel blockers and cardiovascular agents(amiodarone, dicoumarol, diltiazem, nifedipine, ticlopidine, reserpine, digitoxin, digoxin, mexiletine, nicardipine, nimodipine, nisoldipine, quinidine, verapamil, disopyramide used to treat high blood pressure and some heart problems);
• H2-antagonists(cimetidine), proton pump inhibitors(omeprazole), antacids(used to treat stomach disorders);
• HMG-CoA reductase inhibitors(fluvastatin, atorvastatin, simvastatin used to reduce cholesterol levels in the blood);
• hormones (oestrogens) and oral contraceptives(used to treat menopause disorders, to prevent pregnancy and/or for other disorders of the female genital system); Aurantin may interfere with the activity of hormonal contraceptives;
• immunosuppressant drugs(tacrolimus, cyclosporine used to treat disorders of the immune system and following organ transplantation);
• oral hypoglycaemic agents(tolbutamide, chlorpropamide, gliburide, for the treatment of diabetes);
• antidepressants(fluoxetine, fluvoxamine, sertraline, clozapine, paroxetine, quetiapine, sertraline used to treat depression);
• antiretrovirals(fosamprenavir, nelfinavir, ritonavir, efavirenz, indinavir, lopinavir, saquinavir used to treat infections caused by viruses);
• bronchodilators(such as theophylline, used to treat asthma);
• folic acid(used in case of deficiency of this vitamin, especially during pregnancy);
• hyperglycaemic agents(diazoxide which increases blood sugar levels);
• antihelminthics(albendazole, praziquantel used to treat infections caused by parasites in the intestine);
• corticosteroids(for the treatment of inflammation and allergies);
• coumarin anticoagulants(such as warfarin, which are used for some circulatory disorders);
• diuretics(furosemide which facilitate the elimination of urine);
• neuromuscular blocking agents(alcuronium, cisatracurium, pancuronium, rocuronium, vecuronium used to relax muscles during surgical procedures);
• opioid analgesics(such as methadone, used to relieve pain and to treat drug addictions);
• vitamin D(used to restore levels of this vitamin when they are excessively low in the body).

Duringtreatment with this medicine, avoid taking products containing St John's Wort
(Hypericum perforatum).
Aurantin can alter the results of some blood tests (iodine-binding proteins, dexamethasone or
metirapone test, glucose levels, alkaline phosphatase, gamma-glutamyl transpeptidase) and some tests performed to
evaluate calcium and sugar levels in the blood.

Aurantin with alcohol
During treatment with this medicine, avoid drinking alcoholic beverages, as alcohol can alter
the effectiveness of phenytoin.

Pregnancy and breastfeeding
If you are pregnant, suspect you are pregnant, or are planning a pregnancy, or if you are breastfeeding with
breast milk, ask your doctor or nurse for advice before this medicine is given to you.

Pregnancy
If you are pregnant, your doctor will carefully assess the risk-benefit ratio before
giving you this medicine as Aurantin crosses the placenta and is toxic to the fetus (see
“Aurantin must not be given to you or your child”). Aurantin can cause congenital malformations,
tumors and blood clotting disorders in the baby. If this medicine is given to you during pregnancy, the risk of congenital malformations in the newborn may double or
triple compared to normal. The most frequently observed malformations in the baby affect the
upper lip (cleft lip), the heart and blood vessels, that part of the fetus from which the
central nervous system will originate (called the neural tube) and there may be delays in the growth
of the baby. Effects on the fetus include abnormal facial features and incomplete development of fingers and
nails. If you are given Aurantin together with other similar antiepileptic drugs, the risk of
congenital malformations in the newborn will increase even further. Your doctor may take some blood
samples to assess the most appropriate dose of this medicine for your condition.

Breastfeeding
Small amounts of this medicine are excreted in breast milk. If your doctor believes you can
stop treatment with Aurantin and breastfeed, the doses will be gradually reduced
to avoid new seizures and serious consequences for you and your
child (see section “If you stop taking Aurantin”).

Driving and operating machinery
During treatment with this medicine, it is not recommended to drive vehicles or operate
machinery, as Aurantin can alter reaction times.

Aurantin contains ethyl alcohol and sodium
This medicine contains 11% vol of ethanol (alcohol), e.g. up to 440 mg per dose, equivalent to 11.2 ml
of beer, 4.7 ml of wine per dose.
May be harmful to alcoholics.
To be taken into consideration in pregnant or breastfeeding women, children and high-risk groups such as
people suffering from liver disease or epilepsy.
This medicine contains less than 1 mmol (23 mg) of sodium per dose, i.e. it is practically “sodium-free”.

3. How to administer Aurantin

This medicine will be administered to you or your child by a doctor or nurse in hospital or
another specialized center where adequate cardiac resuscitation equipment is available. If you have
any doubts, consult your doctor or nurse.
Aurantin will be administered to you or your child preferably via an injection into a vein
(intravenous injection) and will be injected slowly.

Duringadministration, the doctor or the doctor caring for your child must monitor the
heart function (electrocardiogram) and blood pressure and observe you carefully, as
you may experience severe breathing obstruction (respiratory depression).
In the most serious cases, when phenytoin alone is unable to control epileptic seizures, the doctor
may decide to administer to you or your child also a general anesthetic that is normally
used during surgical operations.
More detailed information on dosage, use and preparation of Aurantin is reported at the end of the package
leaflet under “The following information is intended exclusively for healthcare professionals”.

Use in people with liver problems
If you or your child suffer from liver dysfunction problems (reduced hepatic function), the
doctor or the doctor caring for your child may reduce the maintenance dose to prevent
Aurantin from accumulating excessively in the body, causing serious toxic effects.

Use in people with severe kidney problems
If you or your child suffer from severe kidney problems (uremia), the doctor or the doctor caring for your
child may prescribe you the minimum effective dose to control epileptic seizures.

If more Aurantin is administered than prescribed
If you believe that more Aurantin than necessary has been administered to you or your child, inform
your doctor or nurse immediately, as the following symptoms may occur (see also paragraph 4 “Possible
undesirable effects”):
rhythmic and involuntary eye movements (nystagmus);
loss of coordination of movements (ataxia);
speech disorder (dysarthria);
irreversible brain damage, cerebellar dysfunction and/or cerebellar atrophy
tremor;
increased reflexes (hyperreflexia);
excessive drowsiness (lethargy);
nausea;
vomiting;
severe state of unconsciousness (coma);
low blood pressure (hypotension).
These symptoms, in the most serious cases, can also lead to death due to respiratory and
cardiac activity blockage (respiratory and circulatory depression). The doctor will take the most appropriate
measures according to your conditions.

If you stop treatment with Aurantin
Do not abruptly stop therapy without consulting your doctor, as this may lead to an increase
in the frequency of seizures. Any dose reduction, treatment discontinuation or
replacement with another antiepileptic medicine must occur exclusively under medical supervision and
gradually. If you or your child experience allergic reactions, the doctor may quickly replace
therapy with another medicine that does not belong to the same group as Aurantin.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
The following side effects may occur:

Very rare(may affect up to 1 in 10,000 people)

• enlargement of the lymph nodes (benign lymphoproliferative hyperplasia, pseudolymphoma, lymphoma, Hodgkin's disease) which may be accompanied by fever, skin irritation (rash) and liver problems (hepatic involvement). In these cases, the doctor must monitor you and your child and administer other medicines to control seizures.
• reduction in the number of platelets (thrombocytopenia), white blood cells (leukopenia, granulocytopenia, agranulocytosis) or all components (pancytopenia) in the blood. These disorders can sometimes be fatal and may also be accompanied by a loss of bone marrow activity (bone marrow suppression). In some cases, an increase in the size and number of red blood cells (macrocytosis and megaloblastic anemia) may occur;
• allergic reactions to the medicine (immune-mediated hypersensitivity syndrome/drug reaction with eosinophilia and systemic symptoms (HSS/DRESS) and other immune system disorders (systemic lupus erythematosus, polyarteritis nodosa, immunoglobulin abnormalities);
• serious liver problems (acute hepatic failure, toxic hepatitis, liver damage);
• vomiting, nausea, constipation;
• fragility of the bones (osteopenia, osteoporosis) and increased fractures, in people who are undergoing therapy with this medicine for long periods of time.

Not known(frequency cannot be estimated from available data)

• severe allergic reactions (anaphylactoid and anaphylaxis);
• irritation, inflammation and pain at the injection site and, in some cases, leakage of the injected solution from the vein;
• tissue damage and death (necrosis, eschars), in case of inadequate administration (subcutaneous or perivascular injection);
• purple glove syndrome characterized by swelling due to fluid accumulation (edema, skin discoloration and pain even in areas far from the injection site);
• irregularities in the heart rhythm (atrial and ventricular arrhythmias), reduced heart rate (bradycardia), complete cessation of heartbeat (cardiac arrest and death);
• lowering of blood pressure (hypotension) which, in the most severe cases, can cause serious heart and circulatory problems (cardiovascular collapse);
• difficulty breathing (respiratory function alterations) and, in the most severe cases, cessation of breathing (respiratory arrest);
• rhythmic and involuntary eye movements (nystagmus), loss of coordination (ataxia), problems in articulating words (dysarthria) and mental confusion;
• dizziness, altered sensation in different parts of the body (paresthesia), vertigo, drowsiness, insomnia, transient nervousness, spontaneous muscle contractions (fasciculations) and headache;
• seizures characterized by increased muscle tone (tonic seizures);
• movement disorders (dyskinesia, chorea, dystonia and tremors and akathisia);
• altered taste;
• severe nerve disease (predominantly sensory peripheral polyneuropathy);
• enlargement of the gums (gingival hyperplasia); more frequent in children or people with poor oral hygiene;
• skin disorders (dermatological manifestations), accompanied by fever and skin irritation (skin rashes similar to scarlet fever or measles);
• severe skin diseases (bullous, exfoliative or purpuric dermatitis, lupus erythematosus, Stevens-Johnson syndrome and toxic epidermal necrolysis) which can also be fatal;
• phenytoin can cause abnormalities in thyroid function test results.

Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any side effects not listed in this leaflet. You can also report side effects directly through the national reporting system at the address:https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store Aurantin

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the packaging and on the vial after
“Exp.”. The expiry date refers to the last day of that month.
Do not store at a temperature above 25° C.
Store in the original packaging to protect the medicine from light.
Do not dispose of any medicine in wastewater or household waste. Healthcare professionals know how to
dispose of medicines that are no longer used. This will help protect the environment.

6. Contents of the pack and other information

What Aurantin contains
The active ingredient is phenytoin sodium.
Each vial contains 250 mg of phenytoin sodium.
The other ingredients are: propylene glycol, ethyl alcohol, sodium hydroxide(see section 2 “Aurantin
contains ethyl alcohol and sodium”), water for injections.

Description of the appearance of Aurantin and contents of the pack
The injectable solution of Aurantin 250 mg/5 ml is available in a pack of 5 vials of 5 ml.

Marketing Authorisation Holder
Pfizer Established Medicine Italy S.r.l.
Via Isonzo,71
04100 Latina

Manufacturer
Actavis Italy S.p.A.
Viale Pasteur, 10
20014 Nerviano (MI)

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The following information is intended exclusively for healthcare professionals
AURANTIN 250 mg/5 ml solution for injection
Phenytoin sodium

DOSAGE AND METHOD OF ADMINISTRATION
Dosage

Treatment of status epilepticus
In a patient with continuous seizures, comparable to the most common rapidly recurring seizures such as
serial epilepsy, the intravenous use of diazepam is recommended before the administration of Aurantin due to its rapid onset of effect.
After diazepam administration in patients with continuous seizures and in the initial treatment of serial epilepsy, an initial dose of 10 mg/kg to 15 mg/kg of phenytoin should be injected intravenously slowly at a rate not exceeding 50 mg/minute (this requires approximately 20 minutes in a 70 kg subject). The initial dose should be followed by maintenance doses of 100 mg orally or
intravenously every 6-8 hours.
Oral absorption of phenytoin in neonates is unreliable; however, an initial dose of 15 mg/kg to
20 mg/kg of Aurantin intravenously produces serum phenytoin concentrations within the generally accepted therapeutic range (10-20 mg/l). The drug should be injected slowly into a vein
at a rate of 1-3 mg/kg/minute or at a rate not exceeding 50 mg/minute (depending on which
is slower).
Determination of plasma phenytoin levels is advisable when using Aurantin for the
treatment of status epilepticus and for subsequent definition of the maintenance dosage. The clinically effective level is usually 10-20 mg/l, although some cases of tonic-clonic seizures may be
controlled with lower serum levels.
Phenytoin clearance tends to decrease with increasing age (a 20% reduction in patients over
70 years of age compared to the percentage present in patients aged 20-30 years). Phenytoin administration requirements are highly variable and must be determined on a case-by-case basis.
Intramuscular administration should not be used for the treatment of status epilepticus since, with this route, reaching peak plasma levels may take up to 24 hours.

Treatment of cardiac arrhythmias
Initially administer a dose of 3.5 mg/kg to 5 mg/kg intravenously. If necessary, repeat the
dose once. The solution should be injected slowly intravenously at a rate not
exceeding 1 ml (50 mg) per minute.

Other indications
It is not possible to define a valid therapeutic regimen for all other indications. The intravenous route of
administration is preferred. Dosages and intervals between administrations will be
determined according to the needs of individual patients. Factors such as
previous antiepileptic therapies, degree of seizure control, age and general medical conditions of the
patient must be taken into consideration. Despite the slow absorption of Aurantin when injected intramuscularly, its use with
this route of administration may be appropriate in some conditions.
When temporary intramuscular administration is necessary in patients previously
stabilized with phenytoin orally, it is essential to make appropriate dosage adjustments to
maintain therapeutic serum levels. A dose of 50% higher than the oral dose is necessary
to maintain these levels. When returning to oral treatment, the dose should be reduced by 50% compared to
the initial oral dose in order to avoid reaching excessively high serum levels due to the
prolonged release from the intramuscular injection sites.
In a patient previously not treated with phenytoin, Aurantin may be administered intramuscularly at a dose of 100-200 mg (2-4 ml) at intervals of approximately 4 hours for prophylactic purposes during
neurosurgical interventions and continued in the postoperative period for 48-72 hours.
The dosage should then be reduced to a maintenance dose of 300 mg and adjusted in
function of serum levels.
If the patient requires a period of treatment with Aurantin via intramuscular route exceeding one
week, alternative routes of administration such as gastric intubation should be evaluated. For
periods less than one week, the patient who interrupts intramuscular administration should
receive half of the initial oral dose for the same period of time as they were treated via
intramuscularly with Aurantin. Dosage of serum levels is useful as a guide to appropriate dose adjustment.

Use in the elderly (over 65 years of age):phenytoin clearance is slightly reduced in elderly patients
and a lower dosage or less frequent administration may be necessary. However, complications may occur more easily in elderly patients.

Use in children:dosage as for adults. However, children have been shown to tend to
metabolize phenytoin more rapidly than adults. This must be taken into
consideration when defining dosages. Monitoring serum phenytoin levels may be particularly useful in these cases. The drug should be injected slowly into a vein at a rate of
1-3 mg/kg/minute or at a rate not exceeding 50 mg/minute, depending on which is slower.

Use in neonates: oral absorption of phenytoin in neonates is inconsistent; however, a loading dose of 15
mg/kg - 20 mg/kg intravenously produces serum phenytoin concentrations within the generally accepted therapeutic range
(10-20 mg/l). The drug should be injected slowly into a vein at a rate of 1-3
mg/kg/minute.
Method of administration
Rapid infusion may be associated with adverse cardiovascular events (see section 2,
Warnings and precautions)
When possible, phenytoin should be used orally, due to the risks of cardiac and local toxicity
associated with intravenous phenytoin.
For instructions on handling the medicine before administration see section
“Precautions for disposal and handling”.

PRECAUTIONS FOR DISPOSAL AND HANDLING
Before administration, parenteral substances must be visually examined for
the presence of particulate matter and color changes whenever permitted by the solution and the container.
Both the undiluted solution and the infusion mixture can be administered provided
they are free of turbidity and precipitate.
The diluted infusion mixture (phenytoin and saline) should not be refrigerated. If undiluted parenteral phenytoin is refrigerated or frozen, a precipitate is likely to form; this
should dissolve if the solution is returned to room temperature and in this case the
product can still be used. A slight yellowing may develop. Aurantin should not be mixed with common intravenous infusion solutions and in particular with dextrose and
solutions containing dextrose due to the potential formation of precipitates.
This product is for single use only. After opening, unused product must be
discarded.
Aurantin should be injected slowly directly into a large vein using a large needle or an
central venous catheter.
Due to the risk of local toxicity, intravenous phenytoin must be administered directly into
a large peripheral or central vein, through a large-caliber catheter. Before
administration, the potency of the i.v. catheter must be tested with saline solution.
Each intravenous injection of Aurantin should be followed by an injection of sterile saline solution
through the same needle or catheter to avoid local venous irritation due to the alkalinity of the
solution.
Continuous infusions should be avoided. The addition of Aurantin to intravenous infusion solutions
is not recommended due to probable crystallization of phenytoin.
Continuous monitoring of the electrocardiogram and blood pressure is essential. Resuscitation equipment must be
available. The patient should be monitored for the appearance of respiratory depression. If the intravenous administration of Aurantin does
not terminate the epileptic seizure, other measures should be considered, including
general anesthesia.

For further information, consult the Summary of Product Characteristics.