Bromhexine, marketed under brand names such as Bisolvon, is a mucolytic medication used to treat respiratory conditions involving thick or excessive mucus. It was developed in the late 1950s by Boehringer Ingelheim’s research laboratories, patented in 1961, and launched in 1963 under the trademark Bisolvon®. The drug became available for medical use in 1966.

Bromhexine is a mucolytic medicine used to manage respiratory conditions marked by thick or excessive mucus. Acting as an expectorant, it works by thinning and loosening the mucus, making it easier to expel from the airways. This helps reduce chest congestion and enhances breathing in individuals with illnesses such as bronchitis, pneumonia, and the common cold.

BRAND NAMES

  • Bisolvon – A well-known brand of Bromhexine, available in various formulations.

  • Solmux – Another brand that contains Bromhexine as the active ingredient.

  • Mucolysin – A brand name specifically used for a Bromhexine elixir.

MECHANISM OF ACTION

Bromhexine aids respiratory health by reducing mucus thickness and enhancing ciliary activity, promoting effective mucus clearance—crucial in conditions marked by airway inflammation and excess mucus. Additionally, it may help prevent or treat viral infections like influenza, MERS, and COVID-19 by inhibiting the TMPRSS2 receptor, which plays a key role in viral entry into cells.

PHARMACOKINETICS:

Absorption

Bromhexine exhibits linear pharmacokinetics within the dose range of 8 to 32 mg. It is rapidly absorbed from the gastrointestinal tract but undergoes significant first-pass metabolism, with about 75–80% of the dose metabolized during this process. As a result, its bioavailability is reduced to approximately 22–27%.

Distribution

After being given through an IV, bromhexine spreads widely throughout the body. It can cross the blood-brain barrier and, in small amounts, may also reach the placenta. On average, it has a large volume of distribution. Two hours after a dose, bromhexine levels are much higher in the lungs—1.5 to 3.2 times higher in the bronchial tissues and 3.4 to 5.9 times higher in the lung tissue—compared to the amount in the blood.

Metabolism

Bromhexine is almost completely broken down in the body into several hydroxylated compounds, including dibromanthranilic acid. One of its main active metabolites is ambroxol. In a study of human plasma, the major metabolites of ambroxol were identified as (E)-4-HDMB and (E)-3-HDMB, while (Z)-4-HDMB and (Z)-3-HDMB were found in smaller amounts.

Excretion

Bromhexine is almost completely metabolized in the liver, with the majority of its byproducts eliminated through the urine. Less than 1% of the drug is excreted in its unchanged form.

PHARMACODYNAMICS

Bromhexine is a mucolytic agent that acts by altering the composition of bronchial secretions, resulting in thinner mucus that is easier to expel. Its secretolytic action breaks down mucus, while its secretomotor effect enhances mucus movement, helping to clear the airways and reduce coughing.

ADMINISTRATION

For safe and effective use, bromhexine should always be taken exactly as prescribed by a healthcare professional. The doctor will decide the most suitable form (such as tablets, syrup, or inhalation), dosage, and duration of treatment based on factors like your age, weight, the severity of your symptoms, and any underlying medical conditions.

DOSAGE AND STRENGTH

Bromhexine is a mucolytic drug available in tablets, syrup, and oral solutions, typically in strengths of 4 mg, 8 mg, and 16 mg. The dosage and form depend on the patient's age, condition, and the specific product. It is important to follow the doctor's instructions or the directions on the product label to ensure safe and effective use.

Dosage guidelines are usually divided by age group. Adults and children over 12 have different dosing recommendations than younger children. Specific instructions are provided for children aged 6–11 and 2–5 years, while bromhexine is generally not recommended for children under 2 due to safety concerns. Syrup and elixir forms are often available in 4 mg/5 ml and 8 mg/5 ml strengths, and tablets are commonly found in an 8 mg dose.

DRUG INTERACTIONS

Bromhexine may interact with other medications, leading to either beneficial or harmful effects. It's important to consult your doctor or pharmacist and review all your current medications before starting bromhexine.

Beneficial Interactions:

When used with certain antibiotics—such as amoxicillin, erythromycin, and cefuroxime—bromhexine can enhance their concentration in lung tissues. This can improve the effectiveness of these antibiotics in treating respiratory infections.

FOOD INTERACTIONS

Food interactions with bromhexine are not considered significant, and it can typically be taken with or without food. However, some sources recommend taking bromhexine with meals to help reduce the risk of gastrointestinal discomfort, such as nausea or stomach irritation, which are among the more common side effects. Although food does not notably affect the drug's absorption or effectiveness, taking it after eating may improve overall tolerance, especially in individuals with sensitive stomachs. 

CONTRAINDICATIONS

Bromhexine is not recommended for use in individuals who have a known hypersensitivity or an unusual adverse reaction to bromhexine hydrochloride or any other ingredient contained in the product.

SIDE EFFECTS

  • Nausea and vomiting

  • Diarrhea or loose, watery bowel movements

  • Abdominal pain or discomfort

  • Headache

  • Dizziness or drowsiness

  • Rash or other allergic skin reactions

  • Increased sweating

OVER DOSE

An overdose of bromhexine, a mucolytic agent, can cause exaggerated side effects, primarily affecting the gastrointestinal system and central nervous system. While accidental overdose symptoms are typically consistent with the drug's known side effects, severe or intentionally high doses can be dangerous and require immediate medical attention. 

TOXICITY

The oral LD₅₀ of bromhexine in rats is approximately 6 g/kg. Symptoms observed in cases of accidental overdose are similar to bromhexine’s known adverse effects, such as headache, nausea, vomiting, and other related manifestations. In the event of a confirmed or suspected overdose, symptomatic and supportive treatment should be provided, and poison control services should be contacted immediately.