ROGITINE AMPOULES 10MG
Active substance: PHENTOLAMINE MESILATE
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PATIENT INFORMATION LEAFLET
Rogitine ampoules 10 mg
phentolamine mesilate
Read all of this leaflet carefully before you are given this medicine Keep this leaflet. You may need to read it again. If you have any further questions, ask your doctor. This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours. If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet please tell your doctor. The information in this leaflet has been divided into the following sections: 1. What Rogitine is and what it is used for 2. Check before you are given Rogitine 3. How Rogitine is given to you 4. Possible side effects 5. How to store Rogitine 6. Further information 1. What Rogitine is and what it is used for Rogitine belongs to a group of medicines called alpha-blockers. It is used to treat high blood pressure connected with surgery. It will be injected into a vein or muscle by a doctor or nurse. Rogitine is used before or during surgery to treat episodes of high blood pressure caused by phaeochromocytoma (a tumour of the adrenal gland). It may also be used as a test to find out the cause of high blood pressure. 2. Check before you are given Rogitine You should not be given Rogitine: if you are allergic (hypersensitive) to phentolamine, sulphites or any of the ingredients of Rogitine (see Section 6 Further information) if you suffer from low blood pressure if you have ever had a heart attack if you suffer from any other heart problems including angina (chest pain). Take special care with Rogitine Before you are given Rogitine tell your doctor if: you suffer from asthma you have ever had a stomach ulcer you suffer from kidney problems. If any of the above applies to you, or if you are not sure, speak to your doctor before you are given Rogitine. Taking other medicines Tell your doctor if you are taking or have recently taken/used any of the following medicines as they may interfere with Rogitine: medicines to control high blood pressure anti-psychotics (used to improve thoughts, feelings and/or behaviour when these are disturbed) such as risperidone, haloperidol. Please tell your doctor if you are taking or have recently taken/used any other medicines, including medicines obtained without a prescription. Pregnancy and breast-feeding Do not take Rogitine if you are pregnant, trying to become pregnant or breast-feeding. Driving and using machines If you feel dizzy after being treated with Rogitine, do not drive or work with machinery until these effects have worn off. Important information about some of the ingredients of Rogitine Sodium metabisulphite (E223) can cause allergic-type reactions, especially in patients who suffer from asthma or allergies. It may bring about skin rashes or breathing difficulties. 3. How Rogitine is given to you Your treatment with Rogitine will take place in a hospital, under the supervision of a doctor. The doctor will be monitoring your progress carefully during your treatment with Rogitine.
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Treatment with Rogitine The usual adult dose for high blood pressure is 2 to 5 mg injected into a vein, before or during surgery. Your blood pressure will then be checked. The dose can be repeated as necessary until your blood pressure has been lowered. In children a lower dose of 1 mg is injected into a vein. Test with Rogitine A day or so before the test, your doctor may stop other medicines that you are taking, particularly other treatments for high blood pressure, pain killers or sleeping tablets. You will be expected to lie quietly during the test. The usual test dose for an adult is 5 mg injected quickly into a vein or muscle. Blood pressure readings will be taken at regular intervals for between 10 to 45 minutes to see if there is a rapid fall in blood pressure. In children, a lower test dose of 1 mg is injected into a vein or 3 mg is injected into a muscle. Elderly patients will usually be given a lower dose. If you have any further questions on the use of this product, ask your doctor. What to do if you take more Rogitine than you should As this medicine is given to you in hospital, it is very unlikely that an overdose will happen. If anyone receives this medicine by accident, tell the hospital accident and emergency department or a doctor immediately. Show any left over medicines or the empty packet to the doctor. If you forget to take Rogitine As a doctor is giving you this medicine, you are unlikely to miss a dose. If you have any worries, tell a doctor or nurse. 4. Possible side effects Do not worry. Like all medicines, Rogitine can cause side effects, although not everyone gets them. Tell your doctor if you think you have any of these or other problems with Rogitine: dizziness weakness or feeling faint, especially when you stand up fast heart beat or palpitations chest pain of any kind, as heart attacks have occurred occasionally low blood pressure causing flushing, sweating and feelings of apprehension any symptoms of a stroke causing speech, memory or behaviour changes. Other common side effects that may occur include: diarrhoea feeling or being sick stuffy nose flushing of the face. These effects are often mild and may wear off after a few days treatment. If they are severe or last for more than a few days, tell your doctor. If any of the side effects gets worse, or if you notice any side effects not listed in this leaflet, please tell your doctor. 5. How to store Rogitine Rogitine will be stored in the hospital pharmacy. Keep out of the reach and sight of children. Do not use Rogitine after the expiry date which is stated on the carton. The expiry date refers to the last day of that month after EXP. Store in a refrigerator (2C 8C). Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist on how to dispose of medicines no longer required. These measures will help protect the environment. 6. Further information What is in Rogitine? The active ingredient in this medicine is phentoloamine mesilate. The other ingredients are glucose, sodium metabisulphite (E223) and water. What Rogitine looks like and contents of the pack Rogitine comes in cartons of five ampoules. Marketing Authorisation Holder and Manufacturer The product licence holder is: Alliance Pharmaceuticals Ltd, Avonbridge House, Chippenham, Wiltshire, SN15 2BB, UK. Rogitine is manufactured by: Nycomed Austria GmbH, A-4020, Linz, Austria. The information in this leaflet applies only to Rogitine. If you have any questions or you are not sure about anything, ask your doctor. This leaflet was last approved: 14th November 2008 Alliance, Alliance Pharmaceuticals and associated devices are registered Trademarks Alliance Pharmaceuticals Ltd 2008.
2055825 GB
The following information is intended for medical or healthcare professionals only
Rogitine ampoules 10 mg
phentolamine mesilate
1. Dosage
Indication Adults Management of hypertensive episodes in patients with phaeochromocytoma Diagnosis of phaeochromocytoma Rogitine blocking test For the management of hypertensive crises that arise during the pre-operative phase or during induction of anaesthesia, intubation, or surgical removal of the tumour, 2 to 5 mg of Rogitine is injected intravenously and repeated if necessary. The blood pressure response should be monitored. Method of administration
The test is most reliable in detecting phaeochromocytoma in patients with sustained hypertension and least reliable in those with paroxysmal hypertension. False positive tests may occur in patients with hypertension without phaeochromocytoma. Preparation for the test: Sedatives, analgesics and all other medications except those that might be deemed essential (such as digitalis and insulin) are withheld for at least 24 hours, and preferably 48 to 72 hours, prior to the test. Antihypertensive drugs are withheld until blood pressure returns to the untreated, hypertensive level. This test is not performed on a patient who is normotensive. Procedure: (intravenous) The patient is kept at rest in the supine position throughout the test, preferably in a quiet, darkened room. Injection of Rogitine is delayed until blood pressure is stabilised, as evidenced by blood pressure readings taken every 10 minutes for at least 30 minutes. The dose for adults is 5 mg. The syringe needle is inserted into the vein and injection delayed until the pressor response to venepuncture has subsided. Rogitine is injected rapidly. Blood pressure is recorded immediately after injection, at 30-second intervals for the first 3 minutes, and at 60-second intervals for the next 7 minutes. Interpretation: A positive response, suggestive of phaeochromocytoma, is indicated when the blood pressure is reduced by more than 35 mmHg systolic and by 25 mmHg diastolic. A typical positive response is a reduction in pressure of 60mmHg systolic and 25 mmHg diastolic. Usually, the maximal effect is evident within 2 minutes after injection. A return to preinjection pressure commonly occurs within 15 to 20 minutes but may occur more rapidly. A negative response is indicated when the blood pressure is elevated, unchanged, or reduced by less than 35 mmHg systolic and 25 mmHg diastolic after injection of Rogitine. A negative response to this test does not exclude the diagnosis of phaeochromocytoma, especially in patients with paroxysmal hypertension, in whom the incidence of false-negative responses is high. Procedure: (intramuscular) A dose of 5 mg is administered intramuscularly. Interpretation: Blood pressure is recorded every 5 minutes for 30 to 45 minutes following injection. A positive response is indicated when the blood pressure is reduced by 35 mmHg systolic and by 25 mmHg diastolic, or more, within 20 minutes following injection.
Children Management of hypertensive episodes in patients with phaeochromocytoma Diagnosis of phaeochromocytoma Rogitine blocking test Elderly Patients with renal impairment The dosage is 1 mg given intravenously.
The dosage is 1 mg given intravenously or 3 mg given intramuscularly.
In elderly patients, it is advisable to use the lowest dose or a low infusion rate in case of undiagnosed coronary insufficiency. Since no pharmacokinetic studies with Rogitine have been performed in patients with renal impairment, use caution in administering Rogitine to these patients.
2. Disposal Any unused product or waste material should be disposed of in accordance with local requirements.
2055825 GB
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Rogitine ampoules 10 mg
phentolamine mesilate
Read all of this leaflet carefully before you are given this medicine Keep this leaflet. You may need to read it again. If you have any further questions, ask your doctor. This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours. If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet please tell your doctor. The information in this leaflet has been divided into the following sections: 1. What Rogitine is and what it is used for 2. Check before you are given Rogitine 3. How Rogitine is given to you 4. Possible side effects 5. How to store Rogitine 6. Further information 1. What Rogitine is and what it is used for Rogitine belongs to a group of medicines called alpha-blockers. It is used to treat high blood pressure connected with surgery. It will be injected into a vein or muscle by a doctor or nurse. Rogitine is used before or during surgery to treat episodes of high blood pressure caused by phaeochromocytoma (a tumour of the adrenal gland). It may also be used as a test to find out the cause of high blood pressure. 2. Check before you are given Rogitine You should not be given Rogitine: if you are allergic (hypersensitive) to phentolamine, sulphites or any of the ingredients of Rogitine (see Section 6 Further information) if you suffer from low blood pressure if you have ever had a heart attack if you suffer from any other heart problems including angina (chest pain). Take special care with Rogitine Before you are given Rogitine tell your doctor if: you suffer from asthma you have ever had a stomach ulcer you suffer from kidney problems. If any of the above applies to you, or if you are not sure, speak to your doctor before you are given Rogitine. Taking other medicines Tell your doctor if you are taking or have recently taken/used any of the following medicines as they may interfere with Rogitine: medicines to control high blood pressure anti-psychotics (used to improve thoughts, feelings and/or behaviour when these are disturbed) such as risperidone, haloperidol. Please tell your doctor if you are taking or have recently taken/used any other medicines, including medicines obtained without a prescription. Pregnancy and breast-feeding Do not take Rogitine if you are pregnant, trying to become pregnant or breast-feeding. Driving and using machines If you feel dizzy after being treated with Rogitine, do not drive or work with machinery until these effects have worn off. Important information about some of the ingredients of Rogitine Sodium metabisulphite (E223) can cause allergic-type reactions, especially in patients who suffer from asthma or allergies. It may bring about skin rashes or breathing difficulties. 3. How Rogitine is given to you Your treatment with Rogitine will take place in a hospital, under the supervision of a doctor. The doctor will be monitoring your progress carefully during your treatment with Rogitine.
2055825 GB
2055825_GB.indd 1
11.05.2009 11:49:24 Uhr
Treatment with Rogitine The usual adult dose for high blood pressure is 2 to 5 mg injected into a vein, before or during surgery. Your blood pressure will then be checked. The dose can be repeated as necessary until your blood pressure has been lowered. In children a lower dose of 1 mg is injected into a vein. Test with Rogitine A day or so before the test, your doctor may stop other medicines that you are taking, particularly other treatments for high blood pressure, pain killers or sleeping tablets. You will be expected to lie quietly during the test. The usual test dose for an adult is 5 mg injected quickly into a vein or muscle. Blood pressure readings will be taken at regular intervals for between 10 to 45 minutes to see if there is a rapid fall in blood pressure. In children, a lower test dose of 1 mg is injected into a vein or 3 mg is injected into a muscle. Elderly patients will usually be given a lower dose. If you have any further questions on the use of this product, ask your doctor. What to do if you take more Rogitine than you should As this medicine is given to you in hospital, it is very unlikely that an overdose will happen. If anyone receives this medicine by accident, tell the hospital accident and emergency department or a doctor immediately. Show any left over medicines or the empty packet to the doctor. If you forget to take Rogitine As a doctor is giving you this medicine, you are unlikely to miss a dose. If you have any worries, tell a doctor or nurse. 4. Possible side effects Do not worry. Like all medicines, Rogitine can cause side effects, although not everyone gets them. Tell your doctor if you think you have any of these or other problems with Rogitine: dizziness weakness or feeling faint, especially when you stand up fast heart beat or palpitations chest pain of any kind, as heart attacks have occurred occasionally low blood pressure causing flushing, sweating and feelings of apprehension any symptoms of a stroke causing speech, memory or behaviour changes. Other common side effects that may occur include: diarrhoea feeling or being sick stuffy nose flushing of the face. These effects are often mild and may wear off after a few days treatment. If they are severe or last for more than a few days, tell your doctor. If any of the side effects gets worse, or if you notice any side effects not listed in this leaflet, please tell your doctor. 5. How to store Rogitine Rogitine will be stored in the hospital pharmacy. Keep out of the reach and sight of children. Do not use Rogitine after the expiry date which is stated on the carton. The expiry date refers to the last day of that month after EXP. Store in a refrigerator (2C 8C). Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist on how to dispose of medicines no longer required. These measures will help protect the environment. 6. Further information What is in Rogitine? The active ingredient in this medicine is phentoloamine mesilate. The other ingredients are glucose, sodium metabisulphite (E223) and water. What Rogitine looks like and contents of the pack Rogitine comes in cartons of five ampoules. Marketing Authorisation Holder and Manufacturer The product licence holder is: Alliance Pharmaceuticals Ltd, Avonbridge House, Chippenham, Wiltshire, SN15 2BB, UK. Rogitine is manufactured by: Nycomed Austria GmbH, A-4020, Linz, Austria. The information in this leaflet applies only to Rogitine. If you have any questions or you are not sure about anything, ask your doctor. This leaflet was last approved: 14th November 2008 Alliance, Alliance Pharmaceuticals and associated devices are registered Trademarks Alliance Pharmaceuticals Ltd 2008.
2055825 GB
The following information is intended for medical or healthcare professionals only
Rogitine ampoules 10 mg
phentolamine mesilate
1. Dosage
Indication Adults Management of hypertensive episodes in patients with phaeochromocytoma Diagnosis of phaeochromocytoma Rogitine blocking test For the management of hypertensive crises that arise during the pre-operative phase or during induction of anaesthesia, intubation, or surgical removal of the tumour, 2 to 5 mg of Rogitine is injected intravenously and repeated if necessary. The blood pressure response should be monitored. Method of administration
The test is most reliable in detecting phaeochromocytoma in patients with sustained hypertension and least reliable in those with paroxysmal hypertension. False positive tests may occur in patients with hypertension without phaeochromocytoma. Preparation for the test: Sedatives, analgesics and all other medications except those that might be deemed essential (such as digitalis and insulin) are withheld for at least 24 hours, and preferably 48 to 72 hours, prior to the test. Antihypertensive drugs are withheld until blood pressure returns to the untreated, hypertensive level. This test is not performed on a patient who is normotensive. Procedure: (intravenous) The patient is kept at rest in the supine position throughout the test, preferably in a quiet, darkened room. Injection of Rogitine is delayed until blood pressure is stabilised, as evidenced by blood pressure readings taken every 10 minutes for at least 30 minutes. The dose for adults is 5 mg. The syringe needle is inserted into the vein and injection delayed until the pressor response to venepuncture has subsided. Rogitine is injected rapidly. Blood pressure is recorded immediately after injection, at 30-second intervals for the first 3 minutes, and at 60-second intervals for the next 7 minutes. Interpretation: A positive response, suggestive of phaeochromocytoma, is indicated when the blood pressure is reduced by more than 35 mmHg systolic and by 25 mmHg diastolic. A typical positive response is a reduction in pressure of 60mmHg systolic and 25 mmHg diastolic. Usually, the maximal effect is evident within 2 minutes after injection. A return to preinjection pressure commonly occurs within 15 to 20 minutes but may occur more rapidly. A negative response is indicated when the blood pressure is elevated, unchanged, or reduced by less than 35 mmHg systolic and 25 mmHg diastolic after injection of Rogitine. A negative response to this test does not exclude the diagnosis of phaeochromocytoma, especially in patients with paroxysmal hypertension, in whom the incidence of false-negative responses is high. Procedure: (intramuscular) A dose of 5 mg is administered intramuscularly. Interpretation: Blood pressure is recorded every 5 minutes for 30 to 45 minutes following injection. A positive response is indicated when the blood pressure is reduced by 35 mmHg systolic and by 25 mmHg diastolic, or more, within 20 minutes following injection.
Children Management of hypertensive episodes in patients with phaeochromocytoma Diagnosis of phaeochromocytoma Rogitine blocking test Elderly Patients with renal impairment The dosage is 1 mg given intravenously.
The dosage is 1 mg given intravenously or 3 mg given intramuscularly.
In elderly patients, it is advisable to use the lowest dose or a low infusion rate in case of undiagnosed coronary insufficiency. Since no pharmacokinetic studies with Rogitine have been performed in patients with renal impairment, use caution in administering Rogitine to these patients.
2. Disposal Any unused product or waste material should be disposed of in accordance with local requirements.
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11.05.2009 11:49:25 Uhr
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.
