Notus Mucolytic 50Mg/Ml Oral Solution 200Ml

Notus Mucolytic 50Mg/Ml Oral Solution

ACTION AND MECHANISM

- Mucolytic. Carbocysteine ​​is an S-acetylated derivative of the natural amino acid cysteine. It increases the synthesis of sialomucines by activation of sialyl transferase, thereby restoring the normal glycoprotein composition of bronchial mucous secretion, and normalizes the viscoelasticity of bronchial mucus. This results in an improvement in expectoration and a cleansing of the bronchus.

PHARMACKINETICS

Orally:

- Absorption: rapid oral absorption, with a tmax of 1.5 h.

- Distribution: your Vd is 60 l. It tends to accumulate in lung and bronchial mucus, where the maximum concentration is reached at 2 h.

- Metabolism: several inactive sulfur metabolites have been obtained, such as carboxymethyl-cysteine ​​oxide, carboxymethylthiol-cysteine, thiodiglycolic acid or the S-oxide of this acid.

- Excretion: mainly in urine, in unchanged form (80%) or as metabolites (15%). It appears in small amounts in feces (0.3%) and by pulmonary route. The t1 / 2 is 90-120 min.

INDICATIONS

- [BRONCHIAL HYPERVISCOSITY].

* Symptomatic treatment of upper respiratory tract processes, such as [COMMON COLD] and [GRIPE], which present with excess mucous secretion.

POSOLOGY

- Adults and adolescents> 12 years: 15 ml (750 mg) / 8 h. Once the patient improves, it can be reduced to 10 ml (500 mg) / 8 h. Maximum dose 45 ml (2.25 g) / 24 h.

Duration of treatment: consult with the doctor and / or pharmacist if the symptoms do not improve after 5 days.

Missed dose: skip the missed dose and administer the next dose at the usual time. Do not double the next dose.

POSOLOGY IN RENAL INSUFFICIENCY

No specific dosage recommendations have been made. It is recommended to use with caution before the risk of carbocysteine ​​accumulation.

POSOLOGY IN HEPATIC INSUFFICIENCY

No specific dosage recommendations have been made. It is recommended to use with caution before the risk of carbocysteine ​​accumulation.

RULES FOR THE CORRECT ADMINISTRATION

It is recommended to drink a glass of water after each dose. Drink plenty of water during treatment.

Administration with food: administer before meals.

CONTRAINDICATIONS

- Hypersensitivity to carbocysteine ​​or any other active substance related to cysteine, as well as allergy to any other component of the drug.

- [PEPTIC ULCERA] active. Risk of aggravation.

- Children <2 years. Risk of bronchial obstruction.

PRECAUTIONS

- [HYPOTIROIDISM]. Carbocysteine ​​has resulted in cases of transient hypothyroidism in patients with compromised thyroid function. In case of worsening of hypothyroidism, the patient should be evaluated.

- Renal impairment: There are no specific recommendations. However, up to 80% of the medicine is eliminated unchanged in the urine.

- Evaluate the clinical situation in asthmatic patients or with other severe respiratory failure, since the increase in tracheobronchial mucus can increase the symptoms of COPD.

PRECAUTIONS RELATING TO EXCIPIENTS

- This medicine contains sodium salts. To know the exact sodium content, it is recommended to check the composition. Oral and parenteral dosage forms with sodium amounts greater than 1 mmol (23 mg) / maximum daily dose should be used with caution in patients with [RENAL INSUFFICIENCY] or with low sodium diets.

- This medicine contains cochineal red as an excipient. It can cause allergic reactions including [ASTHMA], especially in patients with [SALICILATE ALLERGY].

PATIENT ADVICE

- Drink plenty of water during treatment.

- Do not use cough suppressants while using carbocysteine.

- Consult with the doctor and / or pharmacist if the symptoms get worse or do not improve in 5 days, or if fever, headache or throat occur.

SPECIAL WARNINGS

- The use of mucolytics and expectorants in children under 2 years of age is contraindicated as a consequence of the risk of bronchial obstruction.

INTERACTIONS

- Antitussives Risk of bronchial obstruction, due to inhibition of cough reflex, and increased production and / or fluidization of mucus. Avoid the association.

- Anticholinergics (atropine, antihistamines, tricyclic antidepressants, antiparkinsonians, neuroleptics, MAOIs). They could oppose the effect of carbocysteine.

PREGNANCY

Safety in animals : no adverse reactions have been found for animal reproduction.

Safety in humans : adequate and well-controlled studies in humans are not available. Its administration is only accepted if there are no safer therapeutic alternatives, and the benefits outweigh the possible risks.

Effects on fertility : no specific studies have been conducted on its effects on fertility.

LACTATION

It is unknown if it is excreted with milk, and the consequences it could have for the infant. Is recomended to suspend the lactancy or evy the administration.

CHILDREN

The use of mucolytics in children under 2 years of age has been related to the appearance of bronchial obstruction, as a result of increased production and fluidization of bronchial secretion and insufficient bronchial drainage. Therefore, the use of mucolytics in these children is contraindicated.

In older children, the dosage form and dose should be adapted to the child's age ( see Dosage ).

ELDERLY

No specific problems have been described in the elderly that require a dose adjustment.

EFFECTS ON DRIVING

Its effects do not seem to be especially significant, although we must bear in mind that adverse reactions such as dizziness or dizziness have been described.

ADVERSE REACTIONS

Adverse reactions are described according to each frequency range, being considered very frequent (> 10%), frequent (1-10%), rare (0.1-1%), rare (0.01-0.1%) , very rare (<0.01%) or of unknown frequency (cannot be estimated from the available data).

- Digestive: frequent [NAUSEAS] and [VOMITOS], [DYSPEPSY], [ABDOMINAL PAIN]; rare [DIGESTIVE HEMORRAGY]; frequency unknown [GASTRITIS], [GASTRALGIA].

- Neurological / psychological: rare [CEFALEA], [VERTIGO], [MAREO].

- Respiratory: very rare [BRONCHIAL SPASM].

- Dermatological: rare [EXANTEMATIC ERUPTIONS], [PRURITE]; very rare [ERITEMA].

- Allergic: rare [HYPERSENSITIVITY REACTIONS].

- Endocrinological: frequency unknown [HYPOTIROIDISM].

ADVERSE REACTIONS CONCERNING EXCIPIENTS

- Containing methyl parahydroxybenzoate may cause [HYPERSENSITIVITY REACTIONS] (possibly delayed).

- Containing cochineal red A (E-124) may cause [HYPERSENSITIVITY REACTIONS].

OVERDOSE

Symptoms : potentiation of adverse reactions, especially of the digestive type.

Measures to take :

- Antidote: there is no specific antidote.

- General disposal measures: if ingestion is recent, less than 1 h, gastric lavage may be necessary.

- Treatment: symptomatic treatment. Ensure ventilation, keeping the bronchial tubes free by bronchial aspiration of the mucus.