Acc fluidifying and antidote

Package leaflet

ACETYL CYSTEINE HEXAL 300 mg/3 ml injectable solution for nebulization and endotracheobronchial instillation
Equivalent medicine
THERAPEUTIC PHARMACOLOGICAL CATEGORY
Mucolytic expectorant.
Antidote.
THERAPEUTIC INDICATIONS
Treatment of respiratory disorders characterized by thick and viscous hypersecretion:
acute bronchitis, chronic bronchitis and its exacerbations, pulmonary emphysema, cystic fibrosis, and bronchiectasis.
Antidotal treatment
Accidental or intentional paracetamol poisoning.
Uropathy due to isophosphamide and cyclophosphamide.
CONTRAINDICATIONS
Hypersensitivity to the active substance or to any of the excipients listed in the “Composition” section.
Children under 2 years of age, except for antidotal treatment.
PRECAUTIONS FOR USE
Mucolytics may induce bronchial obstruction in children under 2 years of age. Indeed, the ability to drain bronchial mucus is limited in this age group due to the physiological characteristics of the respiratory tract.
Therefore, they must not be used in children under 2 years of age (see section “Contraindications”).
Administration of antidotal doses in patients weighing less than 40 kg must be performed under strict medical supervision, as there is a potential risk of excessive fluid administration leading to hyponatremia, seizures, and death. It is recommended to carefully read the instructions provided in the section “Dosage, method and duration of administration.”
Patients with bronchial asthma must be closely monitored during therapy; if bronchospasm occurs, treatment must be immediately discontinued.
Particular caution is required when using this medicine in patients with peptic ulcer or a history of peptic ulcer, especially if they are concurrently taking other drugs known to have a gastrotoxic effect.
Administration of acetylcysteine, particularly by aerosol, at the beginning of treatment may liquefy bronchial secretions and simultaneously increase their volume. If the patient is unable to effectively expectorate, postural drainage or, if necessary, bronchoaspiration should be performed to prevent retention of secretions.
Intravenous administration of acetylcysteine requires medical supervision. The occurrence of adverse reactions following intravenous infusion of acetylcysteine is more likely if the drug is administered rapidly or in excessive amounts. Therefore, it is recommended to strictly follow the instructions provided in the section “Dosage, method and duration of administration.”
Administration of acetylcysteine at antidotal doses may prolong the “prothrombin time” (reduced prothrombin index, increased INR).
Important information about excipients in Acetylcysteine Hexal
This medicine contains 2.1 mmol (49.1 mg) of sodium per vial. This should be taken into consideration in patients with impaired renal function or those on a low-sodium diet.
INTERACTIONS
Inform your doctor or pharmacist if you have recently taken any other medicines, including those without a prescription.
Drug-drug interactions
If you are being treated with nitroglycerin-containing medicines, you should consult your doctor. Concomitant administration of nitroglycerin and acetylcysteine causes significant hypotension and dilation of the temporal artery, potentially leading to headache; therefore, blood pressure monitoring is necessary.
Antitussives and acetylcysteine should not be taken simultaneously, as suppression of the cough reflex may lead to accumulation of bronchial secretions.
For inhalation and endotracheobronchial use, Acetylcysteine Hexal may be administered together with common bronchodilators, vasoconstrictors, etc. In such cases, the medicine should be used as quickly as possible.
Available data on antibiotic-acetylcysteine interactions are based on in vitro studies in which the two substances were mixed, showing reduced antibiotic activity. However, as a precaution, it is recommended not to mix antibiotics with acetylcysteine solution.
Drug-laboratory test interactions
Acetylcysteine may interfere with tests for salicylate determination and urine ketone detection.
SPECIAL WARNINGS
Acetylcysteine Hexal has a sulfurous odor when the vial is opened, but this does not interfere with administration of the preparation.
The acetylcysteine solution in the opened vial or transferred to the nebulizer device may exceptionally turn pinkish in color, without compromising the activity or tolerability of the preparation.
Since acetylcysteine may chemically react with certain materials (e.g. rubber, iron, copper), it is advisable to use nebulizers made of glass or plastic and to wash the devices with water after use.
PREGNANCY AND BREAST-FEEDING
Consult your doctor or pharmacist before taking any medicine.
Although teratogenicity studies conducted with acetylcysteine in animals have not shown any teratogenic effects, as with other drugs, administration during pregnancy and breastfeeding should only be carried out when clearly necessary and under direct medical supervision.
EFFECTS ON THE ABILITY TO DRIVE AND USE MACHINES
There are no assumptions or evidence that this medicine may affect the ability to drive vehicles or operate machinery.
DOSAGE, METHOD AND DURATION OF ADMINISTRATION
Accidental or intentional paracetamol poisoning
Initial dose: 150 mg/kg body weight, added to an equal volume of 5% glucose solution and administered intravenously over 15 minutes.
Subsequent doses: 50 mg/kg administered over 4 hours by intravenous infusion with 5% glucose solution, followed by a further dose of 100 mg/kg infused intravenously over 16 hours, always with 5% glucose solution.
Aerosol administration
Nebulize one vial per session, performing 1–2 sessions daily for 5–10 days.
Due to the high tolerability of the preparation, the frequency of sessions and the doses for each session may be modified by the physician within fairly wide limits, depending on the clinical condition and therapeutic response, without the need to clearly differentiate adult and pediatric doses.
Endobronchial instillation
Administer one vial at a time, 1–2 times daily or as needed, using the chosen method (e.g. permanent catheters, bronchoscope, etc.).
Instillations or washes into the ear canal or other cavities
The average dosage is ½ to 1 vial per application.
The secretolytic action of acetylcysteine is enhanced by fluid intake.
OVERDOSE
Intravenous route
Symptoms
Overdose symptoms are similar in nature but more severe than those listed in the “Undesirable effects” section.
Treatment
Management of overdose is based on immediate discontinuation of the infusion, symptomatic treatment, and resuscitation procedures. There are no specific antidotes; acetylcysteine is dialyzable.
Inhalation or endotracheobronchial use
No cases of overdose have been observed in subjects treated by inhalation or endotracheobronchial administration.
Excessive doses by inhalation or endotracheobronchial route may cause excessive and massive liquefaction of secretions; therefore, especially in patients with impaired or depressed cough and expectoration reflexes, instrumental bronchoaspiration may become necessary.
In case of accidental ingestion/overdose of Acetylcysteine Hexal, contact your doctor immediately or go to the nearest hospital.
If you have any doubts about the use of Acetylcysteine Hexal, consult your doctor or pharmacist.
UNDESIRABLE EFFECTS
Like all medicines, Acetylcysteine Hexal can cause adverse effects, although not everyone experiences them.
Inhalation or endotracheobronchial use:
Hypersensitivity, bronchospasm, rhinorrhea, bronchial obstruction, stomatitis, vomiting, nausea, urticaria, skin eruptions (rash), pruritus.
Parenteral use:
Anaphylactic shock, anaphylactic reactions, anaphylactoid reactions, hypersensitivity, tachycardia, bronchospasm, dyspnea, vomiting, nausea, angioedema, urticaria, flushing, skin eruptions (rash), pruritus, facial edema, decreased blood pressure, prolonged prothrombin time.
In very rare cases, severe adverse skin reactions such as Stevens-Johnson syndrome and Lyell syndrome have occurred following acetylcysteine administration.
If signs of mucocutaneous disorders appear, consult a doctor immediately and discontinue acetylcysteine immediately.
Following the instructions in this leaflet reduces the risk of adverse effects.
Reporting of adverse effects
If you experience any adverse effect, including those not listed in this leaflet, consult your doctor or pharmacist. Adverse effects can also be reported directly via the national reporting system at
www.agenziafarmaco.gov.it/it/responsabili. Reporting adverse effects contributes to providing more information on the safety of this medicine.
EXPIRY DATE AND STORAGE
Expiry date: see the date on the packaging.
This date refers to the product stored unopened and correctly stored.
Caution: Do not use the medicine after the expiry date stated on the packaging.
Do not store above 25°C.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer in use. This helps protect the environment.
Keep this medicine out of the sight and reach of children.
COMPOSITION
Each 3 ml vial contains:
Active substance: acetylcysteine 300 mg
Excipients: edetate disodium, sodium hydroxide, ascorbic acid, water for injections.
PHARMACEUTICAL FORM AND CONTENT
Injectable solution for nebulization and endotracheobronchial instillation
Box containing 5 or 10 vials of 3 ml.
MARKETING AUTHORISATION HOLDER
Sandoz S.p.A.
Largo U. Boccioni 1
21040 Origgio (VA)
MANUFACTURERS
EVER Pharma Jena GmbH
Otto-Schott-Strasse
07745 Jena (Germany)
SALUTAS Pharma GmbH
Otto-von-Guericke Allee, 1
39179 Barleben (Germany)