NALOXONE CHLOR MOLT F 0.4MG 1ML

NALOXONE CLORIDRATE MOLTENI INSTITUTIONS

active ingredients

Naloxone Hydrochloride MOLTENI adults 0.4 mg/ml injectable solution A vial contains: Active ingredient: Naloxone Hydrochloride 0,4 mg Naloxone Hydrochloride MOLTENI children 0.04 mg/2 ml injectable solution A vial contains: Active ingredient: Naloxone Hydrochloride 0.04 mg For full list of excipients, see paragraph 6.1.

Excellent

Water for injectable preparations

Therapeutic indications

Naloxone Hydrochloride MOLTENI adults 0.4 mg/ml Antidote in the treatment of acute intoxication by narcotic analgesics. Naloxone Hydrochloride MOLTENI children 0.04 mg/2 ml Respiratory depression of the newborn caused by mother exposure to opioid substances before childbirth.

Contraindications

Hypersensitivity to the active ingredient or any of the excipients.

Population

Naloxone can be administered intravenously, subcutaneous or intramuscularly. Endovenous administration, recommended in emergency situations, results in a faster appearance of pharmacological activity. Since the duration of pharmacological effects of some narcotics may exceed that of naloxone, the patient should be constantly monitored and, if necessary, the administration of the drug should be repeated. It is however recommended to always start the patient, as soon as possible, to an equipped emergency. In case it is necessary to dilute the solution contained in the vial it is possible to use chloride sodium 0.9% (physiological solution) or glucose 5%. Adults Overdose by narcotics (known or suspicious) The initial dose of naloxone, administered intravenously, intramuscular or subcutaneous is 0.4 mg/ml. In case of intravenous administration, a sufficient improvement of the respiratory function is not determined, it is advisable to repeat the dose at intervals of 2–3 minutes. A poor improvement after administration of 2–3 doses of NALOXONE could be caused by any concomitant morbid processes or by the presence of non-opiate drugs. Post-operative depression by narcotics To obtain a partial or complete antagonism of the depressing effects of opioids following surgery, a lower dose of naloxone is required. This should however be established in relation to the patient's response. Naloxone must be administered intravenously, at increasing doses between 0.1 and 0.2 mg, with intervals of 2–3 minutes, to obtain a proper antagonism of the depressing effects induced by narcotics. Within 1–2 hours of first administration, Naloxone may be required to repeat the administration of Naloxone, in relation to the type, quantity and time interval from the last drug administration. Additional intramuscular doses, however, determine a more prolonged effect. Excessive doses of Naloxone can determine a significant decrease in the analgesic effect induced by the astonishing and increase blood pressure. Similarly, too fast antagonism could induce nausea, vomiting, sweating or tachycardia. Children Overdose by narcotics (known or suspicious) The initial dose is 0.01 mg/kg administered intravenous, intramuscular or subcutaneous. The dose can be repeated according to the indications of the administration in adults.

Conservation

Store in the original packaging to protect the medicine from light.

Warnings

Symptoms of acute intoxication by opioids are represented by respiratory depression, comatose state (precoma or coma vigile and in the most severe cases of deep type), pupilal myosis (awakening in the case of contemporary intake of substances with mythriatic effect, in the cases of acute intoxication by petidine and in the terminal states of coma). The administration of vasopressor drugs and reanimation techniques, such as maintaining airway pervity, artificial breathing and heart massage, can be associated to counteract acute poisoning by narcotics. Naloxone is not effective against respiratory depression due to non-opiate drugs. It is necessary to observe carefully the patient after awakening up to 3–6 hours in case of acute intoxication by heroin and up to 24–48 hours in case of acute intoxication by methadone. It is possible in fact that recompaia respiratory depression and that the patient returns in coma after administration of the first effective dose of naloxone, because the duration of antagonist action (20–30 minutes after intravenous administration; 2 hours and half–3 hours after intramuscular or subcutaneous administration) may be less than that of the injected opioid substance, from time to time variable (heroin, morphine, methadone, pentazocin, etc.). Further doses of naloxone may therefore be required after the first effective administration. After the first intervention, it is necessary, therefore, to transfer the patient to the hospital environment also for the timely treatment. Naloxone should be given with caution in cardiopathic patients or those in cardiotoxic medication therapy. Naloxone should be administered with caution in patients who, in previous hours, had important larynxone episodes. Naloxone should be used in infants of mothers who received an opioid substance within 4 hours of childbirth and only as additional therapy in infants who did not establish an independent breathing after ventilation. Naloxone is not effective against respiratory depression due to non-opioidal drugs. The use of naloxone in newborns of opioid dependent mothers is not recommended, as in these patients naloxone can precipitate withdrawal syndrome and typical convulsions of this condition.

Interactions

Naloxone should not be administered simultaneously with clonidine: the hypotensive and bradycardizing effect of chronic clonidine administration can be temporarily attenuated by intravenous administration of naloxone. Therefore it is necessary to carefully monitor blood pressure.

Effects

Below are the undesirable effects of naloxone organized according to the organic systemic classification MedDRA. No sufficient data is available to determine the frequency of the individual effects listed. Heart disease There have been cases of cardiac arrest, hypertension, hypotension, fibrillation and ventricular tachycardia. Pathologies of skin and subcutaneous tissue Sweat, heat and redness. Endocrine diseases Increased growth hormone levels when administered at doses from 0.3 to 4 mg/kg. Gastrointestinal diseases Nausea, vomiting, dysphagia. Diseases of the nervous system Parestesia, seizures, tremors. Memory deficit with doses from 0.3 to 4 mg/kg. Psychiatric disorders Agitation, hallucinations. Kidney and urinary pathologies Stimulate to urination. Respiratory, chest and mediastinic pathologies Dispnea, hypoxia, pulmonary edema and respiratory depression. Hyperventilation at doses from 0.3 to 4 mg/kg. Reporting of unwanted effects If you show any unwanted effect, including those not listed in this sheet, please refer to your doctor or pharmacist. You can also report the side effects directly through the national reporting system at the address www.agenziafarmaco.gov.it/it/responsabili. Reporting the side effects you may contribute to providing more information on the safety of this medicine.

Overdosing

Not relevant.

Not relevant.

Source: Farmadati