Neostigmine Braun 0.5 mg/ml solution for injection
Spain
Table of Contents
Package leaflet: Information for the user
Introduction
B.PACKAGE LEAFLET
Package leaflet: Information for the patient
Neostigmine Braun 0.5 mg/ml injection solution
Neostigmine methylsulfate
Read all of this leaflet carefully before you start using this medicine, because it contains important information for you.
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Keep this leaflet, as you may need to read it again.
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If you have any questions, ask your doctor or nurse.
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This medicine has been prescribed for you only, and you should not give it to other people, even if they have the same symptoms as you, since it could harm them.
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If you experience any adverse effects, consult your doctor, pharmacist, or nurse, even if they are adverse effects not listed in this leaflet. See section 4.
Contents of this leaflet
- What Neostigmine Braun is and what it is used for
- What you need to know before using Neostigmine Braun
- How to use Neostigmine Braun
- Possible side effects
- How to store Neostigmine Braun
- Contents of the pack and other information
1. What Neostigmine Braun is and what it is used for
Neostigmine B.Braun belongs to a group of medicines called cholinesterase inhibitors. These have the main effect of reversing the action of certain muscle relaxants.
Neostigmine Braun may be used in the following situations:
- Diagnosis and treatment of myasthenia gravis (a disorder in which muscles become easily fatigued and weak).
- As an antidote to reverse the effect of certain muscle relaxants such as tubocurarine.
- Prevention and treatment of postoperative urinary retention.
- Prevention and treatment of postoperative gastrointestinal ileus.
2. What you need to know before using Neostigmina Braun
Do not use Neostigmina Braun
??If you are allergic to neostigmine or any of the other ingredients of this medicine (listed in section 6).
??If you have intestinal or urinary obstruction.
??If you have peritonitis.
??If you are receiving suxamethonium, as there is a risk of prolonged respiratory paralysis and even respiratory arrest (see section "Other medicines and Neostigmina Braun").
Inform your doctor if any of the conditions listed above apply to you.
Warnings and precautions
Talk to your doctor, pharmacist, or nurse before starting to use Neostigmina Braun.
The doctor will use neostigmine with extreme caution in patients who have recently undergone intestinal or bladder surgery. Additionally, the doctor will use neostigmine cautiously in patients with cardiovascular diseases (such as irregular heartbeat, decreased heart rate, low blood pressure, recent coronary occlusion), epilepsy, Addison's disease, hyperthyroidism, Parkinson's disease, peptic ulcer, and in asthmatic patients.
In patients with renal disease, the doctor will adjust the dose according to the degree of renal impairment (see section 3).
When neostigmine is used as an antidote (to reverse curare-like blockade), unless there is an increase in heart rate, the doctor is advised to administer atropine concomitantly as indicated in the Neostigmina Braun product information, in order to counteract undesirable effects, especially to prevent bradycardia.
When bradycardia occurs, the doctor will increase the pulse rate with atropine following the instructions in the Neostigmina Braun product information.
During the use of neostigmine, the doctor may employ advanced life support measures (such as endotracheal intubation, mechanical ventilation, cardiac monitoring), as well as atropine and adrenaline for the treatment of hypersensitivity reactions.
Severe allergic reactions to the drug may develop after variable periods (short or long duration).
This medicine contains less than 23 mg of sodium (1 mmol) per millilitre of solution; this is, essentially “sodium-free”.
Other medicines and Neostigmina Braun
Using Neostigmina Braun with other medicines. Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines, such as:
- Aminoglycoside antibiotics, inhaled anaesthetics (such as chloroform, cyclopropane, halothane, methoxyflurane), local anaesthetics administered intramuscularly, subcutaneously or intravenously in high doses, intravenous lidocaine, or quinine.
??Medicines that act by stopping muscle function; as they may oppose the effect of neostigmine on skeletal muscle.
??Atropine and related compounds.
Concomitant use is not recommended, as atropine may mask signs of overdose and may prevent the rapid recognition of a serious drug reaction, among other reasons.
??Procainamide or quinidine
The effects of these drugs may oppose the action of neostigmine, potentially causing immune system problems.
??Muscle relaxants
The phase of blockade of depolarizing muscle relaxants, such as suxamethonium, may be prolonged when used simultaneously with neostigmine. Muscle blockade reduces the effectiveness of drugs for myasthenia gravis on skeletal muscle. It may be necessary for the doctor to temporarily adjust the dose of anti-myasthenic drugs to control symptoms of myasthenia gravis that occur after using a neuromuscular blocker.
??Local anaesthetics
Neostigmine reduces the elimination process of these anaesthetics (such as procaine, tetracaine, and benzocaine), leading to an increased risk of toxicity or harm to the body.
??Cholinesterase inhibitors.
Concomitant use with neostigmine is not recommended, except under medical supervision, due to the possibility of additive toxicity.
??Medicines containing guanadrel, guanethidine, mecamylamine, or trimethaphan.
These may oppose the effects of neostigmine when used simultaneously, producing increased muscle weakness; it is possible that antihypertensive effects may decrease.
??Medicines that lower blood pressure.
Concomitant use of neostigmine with these medicines (such as beta-blockers, e.g. propranolol, atenolol, among others) may cause hypotension and decreased heart rate.
??Corticosteroid medicines.
Administration of methylprednisolone may worsen symptoms and weakness; the patient may require assisted ventilation. Since the adverse effects of concomitant therapy usually occur before the expected benefits, it has been suggested that methylprednisolone should be administered on alternate days and in small doses, gradually increasing the dose until the desired therapeutic effect is achieved.
Use of Neostigmina Braun with food, drinks, and alcohol
Not applicable
Pregnancy and breastfeeding
If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medicine.
Anticholinesterase medicines, such as neostigmine, may cause uterine contractions and induce premature labour when administered intravenously late in pregnancy. The safety of neostigmine during pregnancy and breastfeeding has not been established. Therefore, the doctor must carefully evaluate its use and it should only be used if the benefits outweigh the risks.
Driving and using machines
Neostigmina Braun has a moderate influence on the ability to drive and use machines. It may cause drowsiness and dizziness, which can affect physical and mental abilities required for driving or operating machinery.
Neostigmina Braun contains sodium:
This medicine contains less than 23 mg of sodium (1 mmol) per millilitre of solution; this is, essentially “sodium-free”
3. How Neostigmina Braun is administered
This medicine is prescribed to you by a doctor and will be administered only by a doctor or nurse in a setting equipped with appropriate facilities.
Population | Recommended Dose |
Adults | Myasthenia gravis (muscle weakness):
Antidote for neuromuscular blockade:
Diagnosis of myasthenia gravis:
Prevention and treatment of postoperative intestinal or urinary problems:
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Pediatric | Myasthenia gravis (muscle weakness):
Antidote for neuromuscular blockade:
Diagnosis of myasthenia gravis:
|
Special dosage instructions:
- Patients with hepatic (liver) problems: It is not necessary to change the dose.
- Patients with renal (kidney) problems: The physician will decide whether it is necessary to reduce the dose or increase the time between each administration of the medicine.
If you use more Neostigmina Braun than you should
If you have been administered too much Neostigmina, you may experience the following signs and symptoms:
- Gastrointestinal problems: nausea, vomiting, colic, and diarrhea.
- Ocular problems: constriction of the pupils, blurred vision.
- Cardiac problems: slower or faster heartbeat, low blood pressure, and even cardiac arrest.
- Glandular problems: sweating, salivation, and lacrimation.
- Muscular problems: tremors, contractions that may lead to muscle weakness and fatigue, and even paralysis.
- Respiratory problems: excessive bronchial secretion which may cause asthma and paralysis of the respiratory muscles, which can be fatal.
- Nervous system disturbances: difficulty coordinating muscle movements, excitement, mental confusion, abnormal reflexes, coma, seizures, and respiratory arrest.
If you have been given too much neostigmine, it is necessary to maintain adequate respiration. Your physician will carry out the necessary measures; therefore, it is important that you follow their instructions.
4. Possible adverse effects
Like all medicines, Neostigmine Braun may cause adverse effects, although not everyone experiences them.
Problems with the skin and connective tissue: rashes, skin reaction causing hives and itching, sweating in certain areas of the body.
Problems with the nervous system: impulsive hyperactivity, seizures, loss of voice, headache, dizziness, and hoarseness.
Digestive problems: increased intestinal motility, nausea, vomiting, diarrhoea, difficulty swallowing, gas, abdominal colic, increased salivation.
Heart problems: slower heartbeat, low blood pressure, arrhythmias, sudden loss of consciousness.
Respiratory problems: cough, chest pain, difficulty speaking, increased secretions, and breathing difficulty.
Renal and urinary problems: increased frequency of urination and loss of bladder control or inability to control urination.
Eye problems: pupil constriction, tearing, visual disturbance consisting of double vision, inflammation and redness of the white part of the eye.
Allergic reactions: allergic reactions may occur, including severe reactions.
Other problems: inflamed vein due to a blood clot and excessive sweating.
Reporting of adverse effects
If you experience any type of adverse effect, consult your doctor, pharmacist or nurse, even if it is a possible adverse effect not listed in this leaflet.
You may also report them directly via the Spanish Pharmacovigilance System for Human Medicines: www.notificaRAM.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.
5. Storage of Neostigmine Braun
Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the ampoule and carton after EXP. The expiry date is the last day of the month indicated.
Do not use this medicine if the solution is not clear, colourless, particle-free, or if there are any visible signs of deterioration.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines and packaging that you no longer need. This will help protect the environment.
6.
Composition of Neostigmine Braun
The active substance is Neostigmine methylsulfate:
Each 1 ml ampoule of the injectable solution contains 0.5 mg of Neostigmine methylsulfate.
Each 5 ml ampoule of the injectable solution contains 2.5 mg of Neostigmine methylsulfate.
The other components (excipients) are:
1 ml ampoule:
Sodium chloride
Hydrochloric acid (for pH adjustment)
Water for injections
5 ml ampoule:
Sodium chloride 45 mg
Hydrochloric acid (for pH adjustment)
Water for injections
Appearance of the medicinal product and content of the container
Injectable solution (sterile).
It is a clear, colourless solution.
Containers
Glass ampoules of 1 ml, 5 ml
Pack sizes
100 ampoules of 1 ml
10 ampoules of 1 ml
10 ampoules of 5 ml
Only some pack sizes may be marketed.
Marketing Authorization Holder:
- Braun Medical, S.A.
Ctra. de Terrassa, 121
08191 Rubí (Barcelona),
Spain.
Manufacturer responsible:
Ronda de los Olivares, Parcela 11 Polígono Industrial Los Olivares, 23009 Jaén (Jaén), Spain. | |
Date of the most recent review of this leaflet: 12/2024
Detailed information on this medicinal product is available on the website of the Spanish Agency of Medicines and Health Products (AEMPS) http://www.aemps.gob.es.
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This information is intended for healthcare professionals only:
Neostigmine Braun 0.5 mg/ml solution for injection
Route of administration
Neostigmine Braun 0.5 mg/ml must be administered by healthcare professionals, who will previously or simultaneously administer atropine. It should only be administered by intravenous, intramuscular, or subcutaneous route.
Dosage according to therapeutic indication:
Population | Recommended dose |
Adults | Antimyasthenic: Intramuscular or subcutaneous, 0.25 or 0.5 mg (equivalent to 0.5 or 1 ml of Neostigmina Braun); subsequent doses should be based on patient response. Antidote (curare-like blockade): Intravenous, 0.5 mg to 2 mg (equivalent: 1 ml to 4 ml of Neostigmina Braun), administered slowly, repeated as necessary up to a total dose of 5 mg (equivalent to 10 ml of Neostigmina Braun). NOTE: When neostigmine is administered intravenously, it is recommended to administer it before or simultaneously (in separate syringes) with 0.6 mg to 1.2 mg of atropine sulfate to counteract muscarinic side effects. In cardiac or severely ill patients, it is recommended to assess the exact dose of neostigmine using a peripheral nerve stimulation device. Diagnostic agent (myasthenia gravis): Intramuscular or subcutaneous, 1.5 mg (equivalent to 3 ml of Neostigmina Braun) administered simultaneously (separate syringe) with 0.6 mg of atropine. Significant improvement in muscle weakness occurring within minutes to 1 hour indicates myasthenia gravis. Prevention of postoperative intestinal or vesical atony: Intramuscular or subcutaneous, 0.25 mg (equivalent to 0.5 ml of Neostigmina Braun) immediately after surgery, repeated at 4 to 6-hour intervals for 2 to 3 days. Treatment of postoperative intestinal atony: Intramuscular or subcutaneous, 0.5 mg (equivalent to 1 ml of Neostigmina Braun), as needed. Treatment of urinary retention: Intramuscular or subcutaneous, 0.5 mg (equivalent to 1 ml of Neostigmina Braun); if the patient does not urinate within the first hour, catheterization should be performed. The dose should be repeated after bladder emptying every 3 hours, administering at least five doses. |
Pediatric | Antimyasthenic: Intramuscular or subcutaneous, 0.01 to 0.04 mg/kg body weight (equivalent: 0.02 ml to 0.08 ml of Neostigmina Braun) at 2 to 3-hour intervals. Note: With each dose of neostigmine or on alternate doses, atropine 0.01 mg/kg body weight may be administered intramuscularly or subcutaneously to counteract muscarinic side effects. Antidote (curare-like blockade): Intravenous, 0.04 mg/kg body weight (equivalent to 0.08 ml of Neostigmina Braun), administered with atropine 0.02 mg/kg body weight. Diagnostic agent (myasthenia gravis): Intramuscular, 0.04 mg/kg body weight (equivalent to 0.08 ml of Neostigmina Braun) as a single dose. Intravenous, 0.02 mg/kg body weight (equivalent to 0.04 ml of Neostigmina Braun) or 0.5 mg (equivalent to 1 ml of Neostigmina Braun) per m² of body surface area. |
Special dosage instructions:
No dose adjustment is required in patients with hepatic impairment.
In patients with impaired renal function, dose reduction or prolongation of the dosing interval may be necessary depending on the patient's clinical condition.
Expiry
Single-use containers. Discard any unused remaining contents after administration.