ACTION AND MECHANISM

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

SPECIAL WARNINGS

- It is recommended to monitor the patient for signs of abuse.

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

PATIENT ADVICE

- It can cause drowsiness, so caution is advised when driving, and it should not be combined with drugs or other sedatives such as alcohol.

- Any changes in the patient's behavior or mood should be reported to the doctor.

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

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

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

CONTRAINDICATIONS

- Hypersensitivity to the active ingredients or to any of the included excipients.

- [ASTHMATIC COUGH].

- Cough accompanied by excessive expectoration.

-[RESPIRATORY FAILURE].

- Treatment, concomitantly or in the preceding 2 weeks, with MAOI antidepressants, serotonin reuptake inhibitor antidepressants (SSRIs), bupropion, linezolid, procarbazine and selegiline.

- Patients with fructose intolerance.

- Children under 2 years old.

ADVANCED AGE

Elderly patients are more prone to the adverse effects of dextromethorphan, although this drug has a better safety profile than codeine. Nevertheless, it is recommended to use it with caution.

EFFECTS ON DRIVING

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

PREGNANCY

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

INDICATIONS

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

INTERACTIONS

- Antiarrhythmics (amiodarone, quinidine). Cases of dextromethorphan toxicity have been reported when combined with antiarrhythmics, probably as a result of inhibition of the antitussive's metabolism. A dosage adjustment may be necessary.

- Antidepressants (MAOIs, SSRIs). Serious adverse reactions, including fatal ones, have occurred when dextromethorphan is administered with MAOIs, characterized by serotonin syndrome with agitation, sweating, rigidity, and hypertension. Similar symptoms have been observed when dextromethorphan is combined with a selective serotonin reuptake inhibitor such as paroxetine. This syndrome may be due to the inhibition of the hepatic metabolism of dextromethorphan. It cannot be ruled out that this combination may occur with other serotonergic drugs such as sibutramine. Therefore, it is recommended to avoid this combination and not to administer dextromethorphan until at least 14 days have passed since the end of treatment with the antidepressant.

- Coxibs. Pharmacokinetic studies have shown that plasma concentrations of dextromethorphan may be increased when administered with celecoxib, parecoxib, or valdecoxib. This effect may be due to the inhibition of the hepatic metabolism of dextromethorphan.

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

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

LACTATION

It is unknown whether dextromethorphan and guaifenesin are excreted in breast milk, and if so, whether this could affect the newborn. It is recommended to discontinue breastfeeding or avoid administering this medication.

CHILDREN

The safety and efficacy of dextromethorphan have not been evaluated in children under two years of age, therefore its use is not recommended. Dextromethorphan has been used in children over two years of age, and it has been shown to have fewer side effects than codeine. However, children, and especially younger children, may be more susceptible to adverse reactions from this medication.

GUIDELINES FOR PROPER ADMINISTRATION

- Oral solution: The oral solution can be taken directly or dissolved in another liquid. A glass of water should be drunk after taking the medication.

It is recommended to drink plenty of water during treatment.

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 HEPATIC INSUFFICIENCY

Reduce the dose by half.

PRECAUTIONS

- Persistent or chronic cough. Extreme caution is advised in patients with coughs such as those due to smoking, asthma, emphysema, respiratory failure, and/or productive cough, because inhibiting the cough reflex could impair expectoration and increase airway resistance. If the cough persists for more than a week or is accompanied by high fever, skin rashes, or persistent headache, a doctor should evaluate the patient's condition.

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

- During treatment, a decrease in reaction time or drowsiness may rarely occur, which should be taken into account when driving cars or operating dangerous machinery.

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

- Do not drink alcoholic beverages during treatment.

- [LIVER DISEASE]. Dextromethorphan is metabolized in the liver, so in cases of [LIVER INSUFFICIENCY] or any liver disease, accumulation of the drug may occur. A dosage adjustment may be necessary (See Dosage).

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

- Dependence. Dependence and abuse with dextromethorphan are very rare, although some cases have been reported. Extreme caution is advised, and patients, especially children, should be closely monitored for signs of abuse, such as mood swings, changes in habits or appearance, academic difficulties, misuse of large quantities of cough products, disappearance of medications 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 patients with atopic dermatitis.

PRECAUTIONS RELATING TO EXCIPIENTS

This medicine contains aspartame as an excipient. Aspartame contains a source of phenylalanine, which may be harmful to people with phenylketonuria (PKU), a rare genetic disorder in which phenylalanine builds up because the body is unable to eliminate it properly. 10 mg of aspartame is equivalent to 5.61 mg of phenylalanine.

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: in some cases [DROWSY], dizziness, [HEADACHE], [VERTIGO], and more rarely mental [CONFUSION] have occurred.

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

ADVERSE REACTIONS RELATED TO EXCIPIENTS

This medicine contains sorbitol. Daily doses above 10 g of sorbitol taken orally may have a mild laxative effect and lead to diarrhea.

OVERDOSE

Symptoms: Dextromethorphan has a fairly wide therapeutic margin and does not usually cause significant toxic effects after an overdose. In fact, administration of doses up to 100 times the commonly administered dose has not resulted in serious adverse reactions. It may cause nausea, vomiting, drowsiness, dizziness, blurred vision with miosis, mydriasis due to paralysis of the ciliary body, nystagmus, confusion, excitability, restlessness, nervousness and irritability, ataxia, urinary retention, stupor, and toxic psychosis. Occasionally, mild respiratory depression and comatose state may occur. In children, it may also cause hallucinations, urticaria, insomnia and hyperexcitability, lethargy, or gait disturbances.

Treatment: As this is an opiate, intravenous naloxone may be used in cases of overdose accompanied by respiratory depression or loss of consciousness. Elimination of the drug should be promoted through forced emesis and gastric lavage. Activated charcoal may then be administered.

If more than two hours have passed since ingestion, symptomatic treatment will be initiated. In case of seizures, benzodiazepines may be administered intravenously or rectally, depending on the patient's age.

If necessary, assisted breathing will be initiated.