Dextromethorphan Br Feder*20ml

NAME
DEXTROMETORPHAN HYDROBROMIDRATE FEDERFARMA.CO 15 MG / ML ORAL DROPS, SOLUTION

PHARMACOTHERAPEUTIC CATEGORY
Cough suppressant.

ACTIVE PRINCIPLES
Dextromethorphan hydrobromide.

EXCIPIENTS
Propylene glycol, ethyl alcohol, polyoxyethylene (20), sorbitan monolaurate, citric acid, strawberry flavor, sodium saccharin, methyl p-hydroxybenzoate, propyl p-hydroxybenzoate, purified water.

INDICATIONS
Dextromethorphan hydrobromide is indicated for the symptomatic treatment of dry cough.

CONTRAINDICATIONS / SECONDARY EFFECT
Hypersensitivity to the active substance or to any of the listed excipients; bronchial asthma, COPD (chronic obstructive pulmonary disease), pneumonia, breathing difficulties, respiratory depression; cardiovascular diseases, hypertension; hyperthyroidism; diabetes; glaucoma; prostatic hypertrophy; stenosis of the gastrointestinal and urogenital systems; epilepsy; severe liver disease; children under the age of 12; do not use at the same time or in the two weeks following MAO inhibitor antidepressant drugs; first trimester of pregnancy, breastfeeding.

DOSAGE
Adults and adolescents (12 to 18 years): The generally recommended dose range is 10 mg (approximately 14 drops) to 20 mg (approximately 28 drops) every 6 hours. The maximum dose that can be reached in 24 hours is 80 mg (about 110 drops). Children up to 12 years: dextromethorphan hydrobromide should not be used.

STORAGE
Do not store above 25 degrees C; keep in the original packaging to keep it away from humidity; keep in the original package to protect from light.

WARNINGS
Treatment with dextromethorphan hydrobromide should not be continued beyond 5-7 days. If there is no therapeutic response within a few days, the physician should reassess the situation. Dextromethorphan hydrobromide can be addictive. Following prolonged use, patients may develop tolerance to the drug, as well as mental and physical dependence. Cases of dextromethorphan abuse have been reported. Special care is recommended with adolescents and young adults, as well as with patients with a history of drug or psychoactive substance abuse. Patients with a tendency to abuse or dependence should take dextromethorphan hydrobromide syrup for short periods and under close medical supervision. A chronic cough can be an early symptom of asthma and therefore dextromethorphan hydrobromide is not indicated for the suppression of chronic or persistent cough (e.g. due to smoking, emphysema, asthma, etc.). Dextromethorphan hydrobromide should be administered with particular caution and only on medical advice if the cough is accompanied by other symptoms such as: fever, rash, headache, nausea and vomiting. The drug should not be taken in case of cough nor when the cough is accompanied by profuse secretion. In case of an irritating cough with considerable mucus production, treatment with dextromethorphan hydrobromide should be administered with particular caution and only on medical advice after a careful risk-benefit assessment. During therapy with dextromethorphan hydrobromide the use of alcohol is not recommended. Administer with caution and only after a careful risk-benefit assessment dextromethorphan hydrobromide in patients with cardiovascular disease, hypertension, hyperthyroidism, diabetes, glaucoma, prostatic hypertrophy, stenosis of the gastrointestinal and urogenital tract, epilepsy, impaired liver function in subjects with or are taking antidepressant drugs, such as MAO inhibitor drugs. Dextromethorphan is metabolised by hepatic cytochrome P4502D6. The activity of this enzyme is genetically determined. Approximately 10% of the population is a poor metaboliser for CYP2D6. Poor metabolisers and patients with concomitant use of CYP2D6 inhibitors may experience exaggerated and / or prolonged effects of dextromethorphan. Therefore, caution should be exercised in patients who are poor metabolisers of CYP2D6 or who use CYP2D6 inhibitors. This medicinal product contains ethanol; parahydroxybenzoates (methyl parahydroxybenzoate and propyl parahydroxybenzoate); propylene glycol.

INTERACTIONS
MAO inhibitor drugs: concomitant administration of dextromethorphan hydrobromide with MAO inhibitor drugs is contraindicated. Also, dextromethorphan hydrobromide syrup should not be taken for 2 weeks following MAO inhibitor therapy. The association of these drugs can, in fact, induce the development of a serotonin syndrome characterized by the following symptoms: nausea, hypotension, neuromuscular hyperactivity (tremor, clonic spasm, myoclonus, increased reflex response and rigidity of pyramidal origin), hyperactivity 'of the autonomic nervous system (diaphoresis, fever, tachycardia, tachypnea, mydriasis) and altered mental status (agitation, excitement, confusion), up to cardiac arrest and death. Linezolid and sibutramine: Serotonin syndrome has also been reported following concomitant administration of dextromethorphan hydrobromide with linezolid or sibutramine. Central nervous system inhibitory drugs: concomitant administration of dextromethorphan hydrobromide with drugs with an inhibitory effect on the central nervous system such as hypnotics, sedatives or anxiolytics, or with the intake of alcohol, can lead to additive effects on the central nervous system. CYP2D6 inhibitors: Dextromethorphan is metabolised by CYP2D6 and has extensive first pass metabolism. Concomitant use of potent inhibitors of the CYP2D6 enzyme can increase dextromethorphan concentrations in the body to levels many times above normal. This increases the patient's risk of the toxic effects of dextromethorphan (agitation, confusion, tremor, insomnia, diarrhea and respiratory depression) and of developing serotonin syndrome. Potent inhibitors of CYP2D6 are fluoxetine, paroxetine, quinidine and terbinafine. In concomitant use with quinidine, plasma concentrations of dextromethorphan are increased up to 20-fold, resulting in increased adverse effects on the central nervous system of the agent. Amiodarone, flecainide and propafenone, sertraline, bupropion, methadone, cinacalcet, haloperidol, perfenzain and thioridazine also have similar effects on the metabolism of dextromethorphan. If concomitant use of CYP2D6 inhibitors and dextromethorphan is required, the patient should be monitored and dextromethorphan dose may need to be reduced. Other drugs that inhibit cytochrome P450-2D6 are cimetidine and ritonavir. Secretolytic drugs: if dextromethorphan hydrobromide is used in combination with secretolytic drugs, the reduction of the cough reflex can lead to a serious accumulation of mucus. Grapefruit juice can increase the absorption, bioavailability and elimination of dextromethorphan hydrobromide, with a consequent increase in its toxicity and decrease in its effect.

SIDE EFFECTS
The following are the undesirable effects of dextromethorphan hydrobromide organized according to the MedDRA system organ class. Insufficient data are available to establish the frequency of all single effects listed. Nervous system disorders: somnolence, fatigue, nystagmus, dystonia, dizziness, mental dizziness and bad language. Serotonin syndrome, characterized by: nausea, hypotension, neuromuscular hyperactivity (tremor, clonic spasm, myoclonus, increased reflex response and stiffness of pyramidal origin), hyperactivity of the autonomic nervous system (diaphoresis, fever, tachycardia, tachypnoea, mydriasis) and altered mental state (agitation, excitement, confusion), leading to cardiac arrest and death. Psychiatric disorders: psychosis, hallucinations. Psychic dependence; dextromethorphan has a low risk of abuse and dependence. However, there have been reports of psychic (non-physical) dependence and cases of abuse due to the euphoric effect caused by the substance. Immune system disorders: anaphylactic and anaphylactoid reactions. General disorders and administration site conditions: hyperpyrexia and hyperthermia. Metabolism and nutrition disorders: diabetes mellitus. Gastrointestinal disorders: nausea, vomiting, gastrointestinal disturbances and decreased appetite. Skin and subcutaneous tissue disorders: allergic skin reactions and rashes. The reporting of suspected adverse reactions that occur after the authorization of the drug is important, as it allows continuous monitoring of the benefit / risk ratio of the drug.

PREGNANCY AND BREASTFEEDING
The results of epidemiological studies on a limited sample of the population did not indicate an increase in the frequency of malformations in children who were exposed to dextromethorphan hydrobromide during the prenatal period. However, these studies do not adequately document the period and duration of treatment with dextromethorphan hydrobromide. Reproductive toxicity studies on animals do not indicate a potential risk to humans for dextromethorphan hydrobromide. Dextromethorphan hydrobromide should not be used during the first three months of pregnancy; moreover, since the administration of high doses of dextromethorphan hydrobromide, even for short periods, can cause respiratory depression in newborns, in the following months the drug must be administered only in case of real need and after a careful evaluation of the benefits and risks. . Since excretion of the drug into breast milk is not known and a respiratory depressing effect on the newborn cannot be excluded, dextromethorphan hydrobromide is contraindicated during breastfeeding.