Cinfatos Expectorant 2 Mg/Ml + 20 Mg/Ml Oral Solution 200 Ml (Pet)

Cinfatos Expectorant (2 Mg/Ml + 20 Mg/Ml Oral Solution 200 Ml (Pet))

Dextromethorphan hydrobromide/Guaiphenesin

ACTION AND MECHANISM

- Combination of a central antitussive (dextromethorphan) and an expectorant (guaifenesin).

INDICATIONS

- Symptomatic treatment of catarrhal processes that occur with [DRY COUGH] and unproductive (irritative cough, nervous cough) and expectoration.

POSOLOGY

"ORAL SOLUTION"

- Adults: 1-2 teaspoons of 5 ml (10-20mg dextromethorphan) / 4-6 h. Maximum 60 ml, (120 mg dextromethorphan) / 24 h.

- Children 6-12 years: 1/2-1 teaspoon of 5 ml (5-10mg dextromethorphan) / 4-6 h. Maximum 30 ml (60 mg dextromethorphan) / 24 h.

DOSAGE IN LIVER FAILURE

Cut the dose in half.

RULES FOR CORRECT ADMINISTRATION

- Oral splution: the oral solution can be taken directly or dissolved in some other liquid. A glass of water should be drunk after administration of the drug.

It is recommended to drink a copious amount of water during treatment.

CONTRAINDICATIONS

- Hypersensitivity to dextromethorphan, guaifenesin, [ALLERGY TO OPIOIDS] or to any of the excipients.

- [RESPIRATORY INSUFFICIENCY].

- Asthmatic cough.

- Cough accompanied by excessive expectoration.

- Concomitant treatment or in the preceding 2 weeks with MAOIs ( see Interactions ).

PRECAUTIONS

- Persistent or chronic cough. Extreme precautions are recommended in patients with cough such as that due to smoking, [ASTHMA], [PULMONARY EMPHYSEMA], [RESPIRATORY FAILURE] and/or [PRODUCTIVE COUGH], because by inhibiting the cough reflex, it could alter expectoration and increase airway resistance. If the cough persists for more than a week or if it is accompanied by high fever, skin rash or persistent headache, the clinical situation should be evaluated by a doctor.

- Do not administer to children under 2 years of age without a doctor's indication.

- During treatment, a decrease in reaction capacity or drowsiness may appear, on rare occasions, which must be taken into account in case of driving cars or operating dangerous machinery.

- Do not administer to sedated, debilitated or bedridden patients.

- Do not drink alcoholic beverages during treatment.

- [HEPATOPATHY]. Dextromethorphan is metabolized in the liver, so in the case of [HEPATIC FAILURE] or any liver disease, its accumulation could occur. Dosage readjustment may be necessary (see Dosage).

- It should be administered with caution in patients with heart disease or kidney disease, [ARTERIAL HYPERTENSION], [DIABETES], [EPILEPSY] and [CHRONIC ALCOHOLISM].

- Unit. The presence of dependency and abuse with dextromethorphan is very rare, although some cases have occurred. It is recommended to take extreme precautions and monitor the patient, especially children, in case symptoms of abuse appear, such as mood swings, changes in habits or the person's appearance, school failure, abuse of large amounts of products for cough, disappearance of medicines from the home medicine cabinet or their appearance in the child's room.

- [ATOPIC DERMATITIS]. The administration of dextromethorphan may be associated with the release of histamine, so it should be avoided in the case of patients with atopic dermatitis.

PRECAUTIONS RELATED TO EXCIPIENTS

- This medicine contains sorbitol. Patients with hereditary [FRUCTOSE INTOLERANCE] should not take this medicine.

ADVICE TO THE PATIENT

- It can cause drowsiness, so caution is recommended when driving, and do not combine it with drugs or other sedative substances such as alcohol.

- The doctor should be notified of any change in the patient's behavior or mood.

- The doctor should be notified if the patient is being treated with antidepressants.

- If after a treatment period of one week the cough continues or is accompanied by severe headache, fever or rash, it is advisable to see a doctor.

- It is advisable to drink plenty of water during treatment.

SPECIAL WARNINGS

- It is recommended to monitor the patient in case signs of abuse appear.

- The association of dextromethorphan with MAOI antidepressants should be avoided, leaving at least 14 days of rest between the administration of both drugs.

INTERACTIONS

- Antiarrhythmics (amiodarone, quinidine). Cases of dextromethorphan toxicity have been described when combined with antiarrhythmics, probably as a consequence of inhibition of the antitussive metabolism. A dosage readjustment may be necessary.

- Antidepressants (MAOIs, SSRIs). Serious adverse reactions, including fatal, have occurred with the administration of dextromethorphan and MAOIs, characterized by a serotonergic syndrome with excitement, sweating, rigidity, and hypertension. Similar pictures have been observed when dextromethorphan is combined with a selective serotonin reuptake inhibitor such as paroxetine. This picture could be due to the inhibition of the hepatic metabolism of dextromethorphan. It cannot be ruled out that it appears with other serotonergic drugs such as sibutramine. It is therefore recommended to avoid the association and not administer dextromethorphan until at least 14 days after treatment with the antidepressant.

- Coccybes. In pharmacokinetic studies it has been possible to observe that plasma concentrations of dextromethorphan could be increased when administered together with celecoxib, parecoxib or valdecoxib. The effect could be caused by the inhibition of the hepatic metabolism of dextromethorphan.

- Expectorants and mucolytics. Inhibition of the cough reflex could lead to pulmonary obstruction in the event of increased volume or fluidity of bronchial secretions.

- CNS depressants. Its simultaneous use with other drugs that cause CNS depression potentiates the depressant effects of dextromethorphan.

PREGNANCY

No animal or human studies have been conducted with guaifenesin during pregnancy and although no problems have been reported in humans with dextromethorphan, its use is not recommended in these cases.

LACTATION

It is unknown whether dextromethorphan and guaifenesin are excreted in breast milk, and whether this could affect the newborn. It is recommended to stop lactation or avoid the administration of this medicine.

CHILDREN

The safety and efficacy of dextromethorphan in children under two years of age have not been evaluated, therefore its use is not recommended. Dextromethorphan has been used in children older than two years, demonstrating that it has fewer side effects than codeine. However, children, and especially the youngest, may be more susceptible to the adverse reactions of this medicine.

SENIORS

Elderly patients are more prone to adverse effects from dextromethorphan, although this drug has a higher safety profile than codeine. However, it is recommended to use it with caution.

EFFECTS ON DRIVING

Dextromethorphan may cause mild sedation in certain patients, substantially impairing the ability to drive and/or operate machinery. Patients should avoid operating dangerous machinery, including automobiles, until they are reasonably certain that drug treatment will not adversely affect them.

ADVERSE REACTIONS

During the period of use of dextromethorphan and guaifenesin, the following adverse reactions have been reported, the frequency of which could not be accurately established:

- Digestive: [CONSTIPATION], [NAUSEA], [VOMITING] and gastrointestinal discomfort.

- Neurological / psychological: some cases have produced [SLEEP], dizziness, [HEADACHE], [VERTIGO], and more rarely [CONFUSION] mental.

- Allergic/dermatological: [URTICARIA], [EXANTEMATIC ERUPTIONS].

OVERDOSE

Symptoms: Dextromethorphan has a fairly wide therapeutic range and does not usually give rise to significant toxic effects after overdose. In fact, administration of doses up to 100 times those commonly administered have not resulted in serious adverse reactions. It can cause nausea, vomiting, drowsiness, dizziness, blurred vision with miosis, mydriasis due to ciliary body paralysis, nystagmus, confusion, excitability, restlessness, nervousness and irritability, ataxia, urinary retention, stupor, toxic psychosis. On occasion, mild respiratory depression and a comatose state may appear. In children it can also cause hallucinations, hives, insomnia and hyperexcitability, drowsiness or changes in the way of walking.

Treatment: As it is an opioid, in case of overdose with respiratory depression or loss of consciousness, intravenous naloxone can be used. We will proceed to favor the elimination of the drug by forced emesis and gastric lavage. Activated charcoal can then be administered.

If more than two hours have elapsed since ingestion, symptomatic treatment will be instituted. In the event of seizures, benzodiazepines may be administered intravenously or rectally, depending on age.

If necessary, assisted breathing will be instituted.

Leaflet Cinfatos Expectorant 2 Mg/Ml + 20 Mg/Ml Oral Solution 200 Ml (Pet)