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Symptomatic treatment of catarrhal processes that occur with dry cough, especially that of irritative or nervous nature, and nasal congestion in adults and children over 2 years old
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- Combination of ANTITUSSIVE and DECONGESTING nasopharyngeal.
- COMMON COLD. symptomatic treatment of catarrhal processes that course with DRY COUGH, especially that of irritative or nervous nature, and NASAL CONGESTION.
- Children, oral:
* Children between 6-12 years old: 5 ml / 8 hours.
* Children between 2-5 years old: 2.5 ml / 8 hours.
* Children under 2 years old has not been evaluated safety and efficacy, so their use is not recommended.
RULES FOR THE CORRECT ADMINISTRATION:
The syrup can be taken directly or dissolved in any other liquid. They should drink a glass of water after administration of the medicine.
It is recommended to drink plenty of water during treatment.
- Hypersensitivity to any component of the medicine or [ALLERGY Opioid].
- Severe heart disease or uncontrolled diabetes mellitus.
- Patients in treatment with antidepressants of type MAOIs within 14 days before starting therapy with pseudoephedrine.
- This medicine contains sorbitol. Patients with [FRUCTOSE INTOLERANCE] hereditary should not take this medicine.
- This medicine contains sucrose. Patients with [FRUCTOSE INTOLERANCE] hereditary, glucose-galactose malabsorption, or sucrase-isomaltase insufficiency should not take this medicine.
- This medicine contains cochineal red as an excipient. It can cause allergic-type reactions including asthma, especially in patients with [ALLERGY SALICYLATES].
- This medicine contains sorbitol. greater than 10 g of sorbitol orally daily doses may have a mild laxative effect.
- This medicine contains sucrose. The administration of greater than 5 g daily amounts should be considered in patients with diabetes mellitus.
- [LIVER FAILURE]. an accumulation of dextromethorphan may result.
- Patients with [diabetes], [GLAUCOMA], [HEART] ([FAILURE CORONARIA], [Ischemia Coronary]), [HYPERTENSION], [HIPERTIROIDISMO], [PHEOCHROMOCYTOMA] or [Prostatic Hypertrophy]. Pseudoephedrine may aggravate symptoms. In severe cases, it may be advisable to avoid administration.
- Persistent, or if cough cough associated with smoking [Emphysema PULMONARY], [ASMA], or if [TOS PRODUCTIVE]. Inhibition of cough reflex may cause pulmonary obstruction. Do not exceed one week of treatment without a prescription.
- Unit. Dextromethorphan has led sometimes checkered dependency, so it is recommended to monitor the patient.
Warnings / Tips
ADVICE TO THE PATIENT:
- It is recommended not to exceed the recommended daily doses.
- May cause drowsiness, so we recommend caution when driving, not combined with other sedative medicines or substances like alcohol.
- You must tell the doctor or pharmacist if the patient has diabetes, heart disease, hypertension or glaucoma, and if treated with any other medicine.
- You must tell the doctor if the patient is being treated with antidepressants.
- Notify your doctor any change in behavior or mood of the patient.
- It must stop treatment and seek medical attention if nervousness, severe headache, dizziness, or insomnia, if symptoms persist for more than seven days or if it appears high fever.
- It is advised to drink plenty of water during treatment.
- It is recommended to monitor the patient for abuse if signs.
- Avoid association with MAOIs, leaving a minimum of 14 days between the administration of both medicines.
- It is recommended to periodically monitor blood pressure in hypertensive patients.
- Alcohol. You can enhance the appearance of side effects.
- Antiarrhythmics. Some antiarrhythmic medicines may increase the toxicity of dextromethorphan by inhibition of metabolism.
- Tricyclic antidepressants. potentiation of cardiac stimulant effects, with hypertension and tachycardia may occur.
- Antihypertensives (beta-blockers, diuretics, guanethidine). Pseudoephedrine may antagonize the antihypertensive effects, and even lead to hypertensive crisis when combined with beta-blockers. It is recommended to monitor blood pressure.
- Digitalis. It may increase the risk of cardiac arrhythmias.
- Nervous stimulants (amphetamines, cocaine, xanthine). It could be enhanced nerve stimulation, leading to intense excitability.
- Expectorants and mucolytics. Pulmonary obstruction may occur when inhibited the cough reflex.
- Thyroid hormones. potentiation of cardiac stimulant effects, with hypertension and tachycardia may occur.
- MAOI. MAOIs could lead to serious and potentially fatal when combined with pseudoephedrine (hypertensive crisis) or dextromethorphan (excitation, hypertension) pictures. It is recommended not to administer products with pseudoephedrine or dextromethorphan until at least 14 days of treatment with the antidepressant.
- SSRIs (fluoxetine, paroxetine). It can be increased dextromethorphan toxicity due to the inhibition of its metabolism by these medicines.
- Methyldopa. Hypertensive crisis may occur after coadministration with pseudoephedrine.
- Nitrates. Pseudoephedrine may antagonize the anti-anginal effects of nitrates.
- Sympathomimetics. It may occur potentiation of side effects.
There have been no adequate and well-controlled studies in humans, so the use of this medicine only accepted if no safer therapeutic alternatives.
Pseudoephedrine is excreted in breast milk but is not known whether dextromethorphan does. Infants may be especially sensitive to the adverse effects of these medicines, so it is recommended to discontinue nursing or avoid this medicine.
It has not been evaluated for safety and efficacy in children under two years old, so its use is not recommended. As for older children, it is recommended to be used with caution, as they may be particularly sensitive to the adverse effects of dextromethorphan and sympathomimetic amines.
Effects on driving
This medicine may lead to a slight sedation in selected patients, substantially affect the ability to drive and / or operate machinery. Patients should avoid operating machinery, including automobiles, until they are reasonably certain that the medicine treatment does not affect them adversely.
The components of this medicine do not usually lead to significant adverse reactions. They have been described:
- Digestive. [NAUSEA] and [VOMITING].
- Neurologic / psychological. [Nervousness], [MAREO], [VERTIGO], [EXCITABILITY], [INSOMNIA], [HEADACHE], [DROWSINESS].
- Cardiovascular. [Cardiac arrhythmia], with [TACHYCARDIA] and [PALPITATIONS], especially at high doses or in susceptible patients. [HYPERTENSION] it can also occur.
- Allergic / Dermatological. There have been reports of [HYPERSENSITIVITY REACTIONS], with [URTICARIA] and [Eruptions rash].
Symptoms: An overdose can lead to unspecific sometimes gastrointestinal symptoms such as nausea and vomiting. cardiac arrhythmias, hypertension and symptoms of excitability, with irritability, insomnia and nervousness may also appear. In children there have been reports of hallucinations.
Treatment: It is recommended to establish the usual measures of detoxification, with forced emesis, gastric lavage and administration of activated charcoal, if few hours have elapsed since the overdose. You can favored the elimination by forced diuresis, acidifying the urine, although it is not recommended in severe cases.
Then the patient will be monitored and will proceed to establish a symptomatic treatment. Convulsions, they may be administered intravenously benzodiazepines or rectally, depending on age. If respiratory depression should occur naloxone should be administered.
If necessary, proceed to establish the ventilator.
• Dextromethorphan: 10 mg. Indications: Symptomatic treatment of non-productive forms of cough (dry cough, nervous cough). o.m: 9/17/82
• Pseudoephedrine: 30 mg. Indications: systemic nasal decongestants. max. 360 mg / day, divided into several shots. o.m: 9/17/82
• Sucrose (excipient): 2.84 g.
• Sodium Benzoate (e-211) (excipient): 5 mg.
• Sorbitol (E-420) (excipient): 1 g.
• Red cochineal (e-124) (excipient): 1 mg.