PHENYTOIN INJECTION BP
Active substance: PHENYTOIN SODIUM
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PACKAGE LEAFLET: INFORMATION FOR THE USER
Phenytoin Injection BP
Read all of this leaet carefully before you start using this medicine. Keep this leaet. You may need to read it again. If you have any further questions, ask your doctor or pharmacist. If any of the side effects gets serious, or if you notice any side effects not listed in this leaet, please tell your doctor. In this leaet: 1. What Phenytoin Injection is and what it is used for 2. Before Phenytoin Injection is used 3. How Phenytoin Injection is used 4. Possible side effects 5. How Phenytoin Injection is stored 6. Further information
1. WHAT PHENYTOIN INJECTION IS AND WHAT IT IS USED FOR
Phenytoin is one of a group of medicines called hydantoins. Phenytoin Injection is a medicine which is used to control status epilepticus (serious condition in which seizures (ts) continue for hours or days) or to prevent ts during or after neurosurgery. It can also be used to correct some heart rhythm abnormalities.
2. BEFORE PHENYTOIN INJECTION IS USED Phenytoin Injection should not be used
if you have shown signs of hypersensitivity (severe allergy) to phenytoin or medicines of the same class (hydantoins) in the past in patients with certain heart conditions If possible, tell your doctor if any of the above applies to you before this medicine is used. This medicine must not be injected into an artery. See section 3 for the correct method of administration.
Take special care with Phenytoin Injection
A small number of people being treated with anti-epileptics such as phenytoin have had thoughts of harming or killing themselves. If at any time you have these thoughts, immediately contact your doctor. Serious skin side effects can rarely occur during treatment with Phenytoin Injection. This risk may be associated with a variant in genes in a subject of Chinese or Thai origin. If you are of such origin and have been tested positively carrying this genetic variant (HLA-B*1502), discuss this with your doctor before taking Phenytoin Injection.
isoniazid, rifampicin, and other sulphonamides some antifungals i.e. ketoconazole, uconazole, miconazole some coumarin anticoagulants, e.g. warfarin medicines used to control diabetes e.g. insulin or oral anti-diabetic agents some pain killers and anti-inammatory medicines, i.e. phenylbutazone and salicylates such as aspirin some medicines used to control anxiety, i.e. chlordiazepoxide, diazepam barbiturates, e.g. phenobarbitone and amylobarbitone corticosteroids (used in numerous situations to aid the bodys healing process) some medicines used to treat mental problems such as psychoses and depression, e.g. haloperidol, methylphenidate, monoamine oxidase inhibitors, trazodone, thioxanthenes and tricyclic antidepressants oral contraceptives and other medicines which mimic female hormones, e.g. oestrogen and ethinyloestradiol antiepileptic medicines, e.g. carbamazepine, ethosuximide, mephenytoin, primidone, sodium valproate, sulthiame, valproic acid and trimethadione halothane (an inhaled general anaesthetic) some anti-ulcer medicines, i.e. cimetidine and ranitidine medicines taken to help the heart, i.e. aspirin, beta-blockers, diazoxide, digoxin, disopyramide, dopamine, frusemide, mexiletine, nifedipine, quinidine, reserpine and verapamil medicines often taken while undergoing cancer treatment, i.e. bleomycin, calcium folinate, carboplatin, carmustine, cisplatin, dacarbazine and vinblastine St Johns wort - The herbal remedy St Johns wort (Hypericum perforatum) should not be taken at the same time as this medicine. If you already take St Johns wort, consult your doctor before stopping the St Johns wort preparations others which you may recognise by name: ciclosporin, disulram, folic acid, L-dopa, lignocaine, succinimide, theophylline (a xanthine), methotrexate and vitamin D
If possible, please tell your doctor if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.
Phenytoin and alcohol consumption
The consumption of alcohol, whilst you are being treated with phenytoin can reduce the effectiveness of treatment or increase the side effects.
Pregnancy and breast-feeding
If possible, tell your doctor if you are pregnant, trying to become pregnant or breast-feeding. Your doctor will only use this medicine if the expected benets outweigh any potential risk to your baby. Ask your doctor or pharmacist for advice before taking any medicine.
Special care needs to be taken with Phenytoin Injection
if you have a liver or kidney disorder if you suffer from diabetes If possible, tell your doctor if any of the above applies to you before this medicine is used.
Driving and using machines
Do not drive or use machines if you experience any side effect (e.g. dizziness or drowsiness) which may lessen your ability to do so.
Taking/using other medicines
Special care is needed if you are taking/ using other medicines as some could interact with phenytoin, for example: some antibacterials i.e. doxycycline, ciprooxacin, chloramphenicol,
Important information about some of the ingredients of Phenytoin Injection
This medicinal product contains 10% vol ethanol (alcohol), i.e. up to 1.6 g per 1 g dose of phenytoin, equivalent to 57 ml of a 3.5% vol beer or 14 ml of a 14% vol
Phenytoin Injection BP
The following information is intended for medical or healthcare professionals only Practical information on the preparation/ handling of the medicinal product is provided here. Intra-arterial administration must be avoided in view of the high pH of the preparation.
Incompatibilities
Incompatible with amikacin sulphate, cephapirin sodium, clindamycin phosphate, and many other drugs. It is recommended that phenytoin sodium is not mixed with other drugs or with any infusion solution other than sodium chloride 0.9%.
Instructions for use and handling
For single use. Discard any unused contents.
Q74116
wine. Harmful to those suffering from alcoholism. To be taken into account in pregnant or breast-feeding women, children and high-risk groups such as patients with liver disease or epilepsy. In addition, this medicinal product contains propylene glycol, which can cause alcohol-like symptoms.
3. HOW PHENYTOIN INJECTION IS USED
This medicine will be given to you by a slow injection via a drip into a vein or, more rarely, via an injection into a muscle.
Dose
Your doctor will calculate the correct does of phenytoin for you. The dose will depend upon your medical condition, your size, your age and how well your kidneys, liver and heart are working. Your doctor will tell how well your liver and kidneys are working from blood and urine samples. Where treatment is prolonged, blood samples may be taken to check the level of phenytoin in the blood. Subsequent doses may be increased or decreased accordingly.
joint pain yellowing of the eyes and skin confusion enlargement of facial features including thickening of the lips unusual and excessive hair growth on body and face Peyronies disease (a condition where male patients experience a deformation of the penis which may cause pain when the penis is erect) unusual tiredness or weakness a feeling of nervousness loss of appetite and weight insomnia headache nausea/vomiting constipation
There have been reports of bone disorders including osteopenia and osteoporosis (thinning of the bone) and fractures. Check with your doctor or pharmacist if you are on long-term antiepileptic medication, have a history of osteoporosis, or take steroids. Phenytoin may cause problems with breathing, blood pressure, heart and liver function and blood cell count. Your doctor may do tests to check for these side effects. If any of the side effects gets serious, or if you notice any side effects not listed in this leaet, please tell your doctor.
If you are given too much or too little Phenytoin Injection
As this medicine will be given to you whilst you are in hospital it is unlikely that you will be given too little or too much, however tell your doctor or pharmacist if you have any concerns.
Effects when treatment with phenytoin is stopped
Sudden withdrawal of phenytoin treatment in patients susceptible to ts may cause status epilepticus. In such cases, phenytoin dosage reduction should be gradual, perhaps following a switch to a form of phenytoin which can be taken by mouth.
5. HOW PHENYTOIN INJECTION IS STORED
Keep out of the reach and sight of children
Expiry
This medicine must not be used after the expiry date which is stated on the ampoule and carton after 'EXP'. Where only a month and year is stated, the expiry date refers to the last day of that month.
4. POSSIBLE SIDE EFFECTS
Like all medicines, phenytoin can cause side effects, although not everybody gets them.
Storage
The ampoules should be kept in the outer carton, in order to protect from light, and stored at, or below, 25C. Unused portions of opened ampoules must not be stored for later use.
If any of the following happen, tell your doctor immediately:
severe allergic reaction - you may experience a sudden itchy rash (hives), swelling of the hands, feet, ankles, face, lips, mouth or throat (which may cause difculty in swallowing or breathing), and you may feel you are going to faint rash (can be severe resulting in painful reddening and blistering of the skin, eyes, inside of the mouth and ano-genital region and may lead to skin shedding) swollen lymph nodes (isolated small raised lumps under the skin) chest pains and palpitations These are serious side effects. You may need urgent medical attention.
Visible signs of deterioration
Only clear, colourless solutions should be used. Opaque, cloudy or discoloured solutions should not be used.
6. FURTHER INFORMATION What Phenytoin Injection contains
The active substance is phenytoin sodium. Each millilitre (ml) of solution contains 50 milligrams (mg) of phenytoin sodium. The other ingredients are ethanol, propylene glycol and Water for Injections. See section 2 Important information about some of the ingredients of Phenytoin Injection for further information about ethanol and propylene glycol.
If any of the following happen, tell your doctor as soon as possible:
pain and inammation at the injection site (in rare instances severe tissue damage has required amputation) tightness of the chest or wheezing dizziness/fainting fever persistent pain, tingling or numbness slurred speech muscle twitching and/or rapid uncontrollable eye movements difculties associated with muscular movement: loss of muscle co-ordination, clumsiness or unsteadiness, shaking and loss of muscle tone bleeding, tender or enlarged gums (may be reduced by maintaining good oral hygiene and massaging the gums) The product should be visually inspected for particulate matter and discolouration prior to administration. Phenytoin Injection is suitable for use as long as it remains free of haziness and precipitate. A precipitate might form if the product has been kept in a refrigerator or freezer. This precipitate will dissolve if allowed to stand at room temperature. The product will then be suitable for use. For infusion administration, Phenytoin
What Phenytoin Injection looks like and contents of the pack
Phenytoin Injection is a clear, colourless solution for injection which comes in glass containers called ampoules. It is supplied in packs containing 5 x 250 mg/5 ml ampoules.
Marketing authorisation holder and manufacturer
Hospira UK Limited, Queensway, Royal Leamington Spa, Warwickshire, CV31 3RW, UK This leaet was last approved in 11/2012
Injection should be diluted in 50 - 100 ml of normal saline, with the nal concentration of phenytoin in the solution not exceeding 10 mg/ml. Administration should commence immediately after the mixture has been prepared and must be completed within one hour (the infusion mixture should not be refrigerated). An in-line lter (0.22 0.50 microns) should be used. The diluted form is suitable for use as long as it remains free of haziness and precipitate. 45177/38/12
Q74116
Phenytoin Injection BP
Read all of this leaet carefully before you start using this medicine. Keep this leaet. You may need to read it again. If you have any further questions, ask your doctor or pharmacist. If any of the side effects gets serious, or if you notice any side effects not listed in this leaet, please tell your doctor. In this leaet: 1. What Phenytoin Injection is and what it is used for 2. Before Phenytoin Injection is used 3. How Phenytoin Injection is used 4. Possible side effects 5. How Phenytoin Injection is stored 6. Further information
1. WHAT PHENYTOIN INJECTION IS AND WHAT IT IS USED FOR
Phenytoin is one of a group of medicines called hydantoins. Phenytoin Injection is a medicine which is used to control status epilepticus (serious condition in which seizures (ts) continue for hours or days) or to prevent ts during or after neurosurgery. It can also be used to correct some heart rhythm abnormalities.
2. BEFORE PHENYTOIN INJECTION IS USED Phenytoin Injection should not be used
if you have shown signs of hypersensitivity (severe allergy) to phenytoin or medicines of the same class (hydantoins) in the past in patients with certain heart conditions If possible, tell your doctor if any of the above applies to you before this medicine is used. This medicine must not be injected into an artery. See section 3 for the correct method of administration.
Take special care with Phenytoin Injection
A small number of people being treated with anti-epileptics such as phenytoin have had thoughts of harming or killing themselves. If at any time you have these thoughts, immediately contact your doctor. Serious skin side effects can rarely occur during treatment with Phenytoin Injection. This risk may be associated with a variant in genes in a subject of Chinese or Thai origin. If you are of such origin and have been tested positively carrying this genetic variant (HLA-B*1502), discuss this with your doctor before taking Phenytoin Injection.
isoniazid, rifampicin, and other sulphonamides some antifungals i.e. ketoconazole, uconazole, miconazole some coumarin anticoagulants, e.g. warfarin medicines used to control diabetes e.g. insulin or oral anti-diabetic agents some pain killers and anti-inammatory medicines, i.e. phenylbutazone and salicylates such as aspirin some medicines used to control anxiety, i.e. chlordiazepoxide, diazepam barbiturates, e.g. phenobarbitone and amylobarbitone corticosteroids (used in numerous situations to aid the bodys healing process) some medicines used to treat mental problems such as psychoses and depression, e.g. haloperidol, methylphenidate, monoamine oxidase inhibitors, trazodone, thioxanthenes and tricyclic antidepressants oral contraceptives and other medicines which mimic female hormones, e.g. oestrogen and ethinyloestradiol antiepileptic medicines, e.g. carbamazepine, ethosuximide, mephenytoin, primidone, sodium valproate, sulthiame, valproic acid and trimethadione halothane (an inhaled general anaesthetic) some anti-ulcer medicines, i.e. cimetidine and ranitidine medicines taken to help the heart, i.e. aspirin, beta-blockers, diazoxide, digoxin, disopyramide, dopamine, frusemide, mexiletine, nifedipine, quinidine, reserpine and verapamil medicines often taken while undergoing cancer treatment, i.e. bleomycin, calcium folinate, carboplatin, carmustine, cisplatin, dacarbazine and vinblastine St Johns wort - The herbal remedy St Johns wort (Hypericum perforatum) should not be taken at the same time as this medicine. If you already take St Johns wort, consult your doctor before stopping the St Johns wort preparations others which you may recognise by name: ciclosporin, disulram, folic acid, L-dopa, lignocaine, succinimide, theophylline (a xanthine), methotrexate and vitamin D
If possible, please tell your doctor if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.
Phenytoin and alcohol consumption
The consumption of alcohol, whilst you are being treated with phenytoin can reduce the effectiveness of treatment or increase the side effects.
Pregnancy and breast-feeding
If possible, tell your doctor if you are pregnant, trying to become pregnant or breast-feeding. Your doctor will only use this medicine if the expected benets outweigh any potential risk to your baby. Ask your doctor or pharmacist for advice before taking any medicine.
Special care needs to be taken with Phenytoin Injection
if you have a liver or kidney disorder if you suffer from diabetes If possible, tell your doctor if any of the above applies to you before this medicine is used.
Driving and using machines
Do not drive or use machines if you experience any side effect (e.g. dizziness or drowsiness) which may lessen your ability to do so.
Taking/using other medicines
Special care is needed if you are taking/ using other medicines as some could interact with phenytoin, for example: some antibacterials i.e. doxycycline, ciprooxacin, chloramphenicol,
Important information about some of the ingredients of Phenytoin Injection
This medicinal product contains 10% vol ethanol (alcohol), i.e. up to 1.6 g per 1 g dose of phenytoin, equivalent to 57 ml of a 3.5% vol beer or 14 ml of a 14% vol
Phenytoin Injection BP
The following information is intended for medical or healthcare professionals only Practical information on the preparation/ handling of the medicinal product is provided here. Intra-arterial administration must be avoided in view of the high pH of the preparation.
Incompatibilities
Incompatible with amikacin sulphate, cephapirin sodium, clindamycin phosphate, and many other drugs. It is recommended that phenytoin sodium is not mixed with other drugs or with any infusion solution other than sodium chloride 0.9%.
Instructions for use and handling
For single use. Discard any unused contents.
Q74116
wine. Harmful to those suffering from alcoholism. To be taken into account in pregnant or breast-feeding women, children and high-risk groups such as patients with liver disease or epilepsy. In addition, this medicinal product contains propylene glycol, which can cause alcohol-like symptoms.
3. HOW PHENYTOIN INJECTION IS USED
This medicine will be given to you by a slow injection via a drip into a vein or, more rarely, via an injection into a muscle.
Dose
Your doctor will calculate the correct does of phenytoin for you. The dose will depend upon your medical condition, your size, your age and how well your kidneys, liver and heart are working. Your doctor will tell how well your liver and kidneys are working from blood and urine samples. Where treatment is prolonged, blood samples may be taken to check the level of phenytoin in the blood. Subsequent doses may be increased or decreased accordingly.
joint pain yellowing of the eyes and skin confusion enlargement of facial features including thickening of the lips unusual and excessive hair growth on body and face Peyronies disease (a condition where male patients experience a deformation of the penis which may cause pain when the penis is erect) unusual tiredness or weakness a feeling of nervousness loss of appetite and weight insomnia headache nausea/vomiting constipation
There have been reports of bone disorders including osteopenia and osteoporosis (thinning of the bone) and fractures. Check with your doctor or pharmacist if you are on long-term antiepileptic medication, have a history of osteoporosis, or take steroids. Phenytoin may cause problems with breathing, blood pressure, heart and liver function and blood cell count. Your doctor may do tests to check for these side effects. If any of the side effects gets serious, or if you notice any side effects not listed in this leaet, please tell your doctor.
If you are given too much or too little Phenytoin Injection
As this medicine will be given to you whilst you are in hospital it is unlikely that you will be given too little or too much, however tell your doctor or pharmacist if you have any concerns.
Effects when treatment with phenytoin is stopped
Sudden withdrawal of phenytoin treatment in patients susceptible to ts may cause status epilepticus. In such cases, phenytoin dosage reduction should be gradual, perhaps following a switch to a form of phenytoin which can be taken by mouth.
5. HOW PHENYTOIN INJECTION IS STORED
Keep out of the reach and sight of children
Expiry
This medicine must not be used after the expiry date which is stated on the ampoule and carton after 'EXP'. Where only a month and year is stated, the expiry date refers to the last day of that month.
4. POSSIBLE SIDE EFFECTS
Like all medicines, phenytoin can cause side effects, although not everybody gets them.
Storage
The ampoules should be kept in the outer carton, in order to protect from light, and stored at, or below, 25C. Unused portions of opened ampoules must not be stored for later use.
If any of the following happen, tell your doctor immediately:
severe allergic reaction - you may experience a sudden itchy rash (hives), swelling of the hands, feet, ankles, face, lips, mouth or throat (which may cause difculty in swallowing or breathing), and you may feel you are going to faint rash (can be severe resulting in painful reddening and blistering of the skin, eyes, inside of the mouth and ano-genital region and may lead to skin shedding) swollen lymph nodes (isolated small raised lumps under the skin) chest pains and palpitations These are serious side effects. You may need urgent medical attention.
Visible signs of deterioration
Only clear, colourless solutions should be used. Opaque, cloudy or discoloured solutions should not be used.
6. FURTHER INFORMATION What Phenytoin Injection contains
The active substance is phenytoin sodium. Each millilitre (ml) of solution contains 50 milligrams (mg) of phenytoin sodium. The other ingredients are ethanol, propylene glycol and Water for Injections. See section 2 Important information about some of the ingredients of Phenytoin Injection for further information about ethanol and propylene glycol.
If any of the following happen, tell your doctor as soon as possible:
pain and inammation at the injection site (in rare instances severe tissue damage has required amputation) tightness of the chest or wheezing dizziness/fainting fever persistent pain, tingling or numbness slurred speech muscle twitching and/or rapid uncontrollable eye movements difculties associated with muscular movement: loss of muscle co-ordination, clumsiness or unsteadiness, shaking and loss of muscle tone bleeding, tender or enlarged gums (may be reduced by maintaining good oral hygiene and massaging the gums) The product should be visually inspected for particulate matter and discolouration prior to administration. Phenytoin Injection is suitable for use as long as it remains free of haziness and precipitate. A precipitate might form if the product has been kept in a refrigerator or freezer. This precipitate will dissolve if allowed to stand at room temperature. The product will then be suitable for use. For infusion administration, Phenytoin
What Phenytoin Injection looks like and contents of the pack
Phenytoin Injection is a clear, colourless solution for injection which comes in glass containers called ampoules. It is supplied in packs containing 5 x 250 mg/5 ml ampoules.
Marketing authorisation holder and manufacturer
Hospira UK Limited, Queensway, Royal Leamington Spa, Warwickshire, CV31 3RW, UK This leaet was last approved in 11/2012
Injection should be diluted in 50 - 100 ml of normal saline, with the nal concentration of phenytoin in the solution not exceeding 10 mg/ml. Administration should commence immediately after the mixture has been prepared and must be completed within one hour (the infusion mixture should not be refrigerated). An in-line lter (0.22 0.50 microns) should be used. The diluted form is suitable for use as long as it remains free of haziness and precipitate. 45177/38/12
Q74116
Source: Medicines and Healthcare Products Regulatory Agency
Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.
