ACTION AND MECHANISM

- Mucolytic, expectorant. Bromhexine is a brominated derivative of the alkaloid vasicine, present in the Malabar bean (Adhatoda vasica), traditionally used as an anti-asthmatic. Bromhexine decreases the viscosity of bronchial secretions and increases their volume, while also promoting their expulsion. Its mechanism of action is unknown, although it appears to activate sialyltransferase, responsible for synthesizing sialomucins. The increased synthesis of these proteins restores balance to bronchial mucus production. It may also stimulate the mucous glands of the bronchial epithelium, increase lysozyme levels, which would lead to the breakdown of mucopolysaccharides, and stimulate mucociliary activity.

SPECIAL WARNINGS

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

- In case of the appearance of skin rashes on skin or mucous membranes, bromhexine will be discontinued and the possibility of conditions such as toxic epidermal necrolysis or Stevens-Johnson syndrome will be evaluated.

SENIORS

No specific problems have been described in this age group. Use is acceptable.

PATIENT ADVICE

- Drink plenty of water during treatment.

- Do not use antitussives while using bromhexine.

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

- Inform your doctor and/or pharmacist if skin rashes appear during treatment, sometimes associated with blisters or lesions on the mucous membranes.

CONTRAINDICATIONS

- Hypersensitivity to any component of the medication.

PREGNANCY

There are no adequate and well-controlled studies in humans, so the use of this drug is only acceptable in the absence of safer therapeutic alternatives.

PHARMACOKINETICS

Oral route:

- Absorption: Bromhexine hydrochloride is rapidly absorbed after oral administration, reaching Cmax within one hour. Its bioavailability is reduced to 20% due to extensive first-pass hepatic metabolism.

- Distribution: It is widely distributed throughout the body's tissues, crossing the blood-brain barrier and the placenta in small amounts. It binds to plasma proteins to a high degree.

- Metabolism: Bromhexine is extensively metabolized in the liver, yielding an active metabolite, ambroxol. This ambroxol then undergoes further metabolic reactions, usually conjugation.

- Elimination: Bromhexine is primarily eliminated by metabolism and subsequent excretion of metabolites in urine. Only small amounts of unchanged bromhexine are isolated in urine. Its elimination half-life is approximately 12 hours.

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 bromhexine.

LACTATION

It is unknown whether bromhexine is excreted in breast milk, and if so, whether it could affect the infant. It is recommended to discontinue breastfeeding or avoid administering this medication.

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.

Administration with food: can be taken with or without food.

POSOLOGY

Bisolvon mucolytic

- Adults and adolescents > 12 years, oral: 10 ml (16 mg)/8 h. Maximum dose 30 ml (48 mg)/24 h.

DOSAGE IN HEPATIC INSUFFICIENCY

No specific dosage recommendations have been made. However, in patients with severe hepatic impairment (Child-Pugh class C), bromhexine elimination may be reduced.

DOSAGE IN RENAL INSUFFICIENCY

No specific dosage recommendations have been made. However, in patients with severe renal impairment (CLcr <30 ml/min), bromhexine elimination may be reduced.

PRECAUTIONS

- [RENAL INSUFFICIENCY] severe. In these patients, a decrease in the clearance of bromhexine and its metabolites may occur, with a higher risk of adverse reactions.

- Severe [HEPATIC INSUFFICIENCY]. In these patients, clearance may be reduced, with a consequently higher risk of adverse reactions, therefore close monitoring of the patient is recommended due to the risk of adverse reactions.

- Gastric damage. Administration of mucolytics has been associated with disruption of the gastric protective barrier and gastric damage. Consider their use in patients with a history of gastritis or peptic ulcer.

- Patients with [ASTHMA], [RESPIRATORY FAILURE] or a history of [BRONCHOSPASM]. Increased mucus production could lead to bronchial obstruction in patients who are unable to expectorate adequately.

- Skin toxicity. Reports of severe skin reactions, such as erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis, and acute generalized exanthematous pustulosis, have been received in association with bromhexine administration. If the patient develops symptoms or signs of a progressive rash, sometimes associated with blisters or mucosal lesions, bromhexine treatment should be discontinued immediately and a physician should be consulted.

PRECAUTIONS RELATING TO EXCIPIENTS

This medicine contains maltitol. Patients with hereditary fructose intolerance should not take this medicine.

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: infrequent [NAUSEA], [VOMITING], [DIARRHEA], [ABDOMINAL PAIN]; frequency unknown [GASTRIC HYPERACIDITY].

- Hepatic: frequency unknown [INCREASE TRANSAMINASES].

- Neurological/psychological: frequency unknown [DIZZINESS], [HEADACHE].

- Respiratory: rare [BRONCHIAL SPASM].

- Dermatological: rare [EXANTHEMATOUS ERUPTIONS], [URTICARIA]; frequency unknown [ERYTHEMA MULTIFORME], [STEVENS-JOHNSON SYNDROME], [TOXIC EPIDERMAL NECROLYSIS], acute generalized exanthematous pustulosis.

- Allergic: rare [HYPERSENSITIVITY REACTIONS]; frequency unknown [ANAPHYLAXIS], [ANGIOEDEMA], [PRURITUS].

OVERDOSE

Symptoms: Based on experimental data, it can be said that bromhexine is a very safe and low-toxicity drug.

Treatment: Standard elimination measures will be used, such as gastric lavage, administration of alkalis, and symptomatic treatment. The airways will be kept clear of secretions by positioning the patient on their side and performing bronchial aspiration.

COMPOSITION

BROMHEXINE: 1.6 MILLIGRAMS - HYDROCHLORIDE
MALTITOL (E-965) (EXCIPIENT): 500 MILLIGRAMS