ACTION AND MECHANISM

- Mucolytic. Carbocysteine ​​is an S-acetylated derivative of the natural amino acid cysteine. It increases the synthesis of sialomucins by activating sialyltransferase, thereby restoring the normal glycoprotein composition of bronchial mucus secretion and normalizing the viscoelasticity of bronchial mucus. This results in improved expectoration and bronchial clearance.

SPECIAL WARNINGS

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

SENIORS

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

PATIENT ADVICE

- Drink plenty of water during treatment.

- Do not use antitussives while using carbocysteine.

- Consult your doctor and/or pharmacist if symptoms worsen or do not improve within 5 days, or if fever, headache or sore throat develops.

CONTRAINDICATIONS

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

- Active [PEPTIC ULCER]. Risk of worsening.

- Patients with [ASTHMA], [RESPIRATORY FAILURE], a history of [BRONCHOSPASM], as well as children < 2 years old. Risk of bronchial obstruction.

EFFECTS ON DRIVING

Its effects do not appear to be particularly significant, although it should be noted that adverse reactions such as vertigo or dizziness have been described.

PREGNANCY

Animal safety : no adverse reproductive effects have been found in animals.

Safety in humans : There are no adequate and well-controlled studies in humans. Its administration is only acceptable if there are no safer therapeutic alternatives, and the benefits outweigh the potential risks.

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

PHARMACOKINETICS

Oral route:

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

- Distribution: Its Vd is 60 l. It tends to accumulate in the lungs 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: primarily in urine, either unchanged (80%) or as metabolites (15%). Small amounts appear in feces (0.3%) and are also excreted via the lungs. The half-life (t1/2) is 90-120 minutes.

INDICATIONS

- [BRONCHIAL HYPERVISCOSITY].

INTERACTIONS

- Antitussives. Risk of bronchial obstruction due to inhibition of the cough reflex and increased mucus production and/or thinning. Avoid this combination.

- Anticholinergics (atropine, antihistamines, tricyclic antidepressants, antiparkinsonian drugs, neuroleptics, MAOIs). These could counteract the effect of carbocysteine.

LACTATION

It is unknown whether it is excreted in breast milk, and what the consequences might be for the infant. It is recommended to discontinue breastfeeding or avoid administering it.

CHILDREN

The use of mucolytics in children under 2 years of age has been associated with the development of bronchial obstruction, resulting from increased production and thinning of bronchial secretions and insufficient bronchial drainage. Therefore, the use of mucolytics in these children is contraindicated.

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

GUIDELINES FOR PROPER ADMINISTRATION

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

POSOLOGY

- Adults, oral: 15 ml (750 mg)/8 h. Once the patient improves, it can be reduced to 10 ml (500 mg)/8 h.

- Children and adolescents under 18 years of age:

* Adolescents > 12 years: 15 ml (750 mg)/8 h. Once the patient improves, it can be reduced to 10 ml (500 mg)/8 h.

* Children 6-12 years: 5 ml (250 mg)/8 h.

* Children 2-5 years: 2.5 ml (125 mg)/6-12 h.

* Children < 2 years: contraindicated.

- Elderly, oral: no dosage adjustment required.

Administration with food : administer before meals.

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

Missed dose : Skip the missed dose and take the next dose at the usual time. Do not double the next dose.

DOSAGE IN HEPATIC INSUFFICIENCY

No specific dosage recommendations have been made. Use with caution due to the risk of carbocysteine ​​accumulation.

DOSAGE IN RENAL INSUFFICIENCY

No specific dosage recommendations have been made. Use with caution due to the risk of carbocysteine ​​accumulation.

PRECAUTIONS

- Patients with [RENAL INSUFFICIENCY] or [HEPATIC INSUFFICIENCY], due to the risk of accumulation.

- [HYPOTHYROIDISM]. Carbocysteine ​​has been associated with cases of hypothyroidism. If hypothyroidism worsens, the patient should be re-evaluated.

PRECAUTIONS RELATING TO EXCIPIENTS

- Because it contains methyl parahydroxybenzoate, it may cause allergic reactions (possibly delayed).

ADVERSE REACTIONS

Adverse reactions are described according to each frequency interval, being considered very common (>10%), common (1-10%), uncommon (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 [NAUSEA] and [VOMITING], [DYSPEPSIA], [ABDOMINAL PAIN]; rare [GASTROINTESTINAL BLEEDING]; frequency unknown [GASTRITIS], [GASTRALGIA].

- Neurological/psychological: rare [HEADACHE], [VERTIGO], [DIZZINESS].

- Respiratory: very rare [BRONCHIAL SPASM].

- Dermatological: rare [EXANTHEMATOUS ERUPTIONS], [PRURITUS]; very rare [ERYTHEMA].

- Allergic: rare [HYPERSENSITIVITY REACTIONS].

- Endocrinological: frequency unknown [HYPOTHYROIDISM].

OVERDOSE

Symptoms : increased adverse reactions, especially digestive ones.

Measures to be taken :

- Antidote: there is no specific antidote.

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

- Treatment: Symptomatic treatment. Ensure ventilation by keeping the bronchi clear through bronchial aspiration of mucus.

COMPOSITION

CARBOCYSTEINE: 50 MILLIGRAMS
SUCROSE (EXCIPIENT): 300 MILLIGRAMS
SODIUM SALTS (EXCIPIENT): 8.92 MILLIGRAMS
METHYL PARAHYDROXYBENZOATE (E-218) (EXC): 1.8 MILLIGRAMS - SODIUM (SALT)
PROPYL PARAHYDROXYBENZOATE (E-216) (EXC: 0.4 MILLIGRAMS - SODIUM (SALT)