Brommy Actions

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Actions of Brommy in details

Brommy is a synthetic derivative of the herbal active ingredient vasicine. Preclinically, it has been shown to increase the proportion of serious bronchial secretion. Brommy enhances mucus transport by reducing mucus viscosity and by activating the ciliated epithelium (mucociliary clearance).

In clinical studies, Brommy showed a secretolytic and secretomotor effect in the bronchial tract area, which facilitates expectoration and eases cough. Pharmacokinetics: Brommy is absorbed well by the enteral route, the absorption half-life of a Brommy solution is 0.4 hrs. Following oral intake of Brommy tablets, the peak plasma concentration is reached within approximately 1 hr (t_max). Brommy is subject to a first-pass effect of 75-80%; the absolute bioavailability of oral dosage forms is therefore given as 20-25% (37,40). Food before administration of Brommy enhances the bioavailability of the compound.

Following pre-oral administration, Brommy shows dose linearity in the dose range 8-32 mg. At least 10 different Brommy metabolites have been discovered in the plasma, including the pharmacologically active metabolite ambroxol.

There is a high level of plasma protein-binding at 95-99% and a large distribution volume of 7 L/kg body weight (IV administration). Brommy accumulates in the lung rather than in the plasma.

The dominant elimination half-life is given as 1 hr, the terminal elimination half-life is 13-40 hrs. Following oral administration of 8 mg, the plasma levels fell after 8-12 hrs to 1.5 ng/mL and 0.2 ng/mL, respectively. For the most part, Brommy is excreted renally in the form of metabolites that pass through the kidneys while only minor amounts of 0-10% parent compound are found in unchanged form in the urine. After 24 hrs and 5 days, 70% and 88% of the oral dose, respectively is recovered in the urine, 4% is excreted with the feces.

Brommy does not cumulate as the long terminal elimination half-life is not dominant. Steady-state levels are reached after 3 days at the latest.

In animal studies, Brommy penetrates the cerebrospinal fluid and the placenta. It is expected that the compound is excreted in breast milk.

Reduced clearance of Brommy parent substance can be expected in the case of severe liver disease; in the case of severe renal insufficiency, cumulation of metabolites cannot be ruled out; pharmacokinetic studies for these conditions are not available.

Toxicology: Acutely, Brommy has a very low index of toxicity:

Oral LD

₅₀ values were >5 g/kg in rats, >4 g/kg in rabbits, >10 g/kg in dogs and >1 g/kg in newborn rats. The intraperitoneal LD₅₀ in rats was 2 g/kg. The LD₅₀ values for the syrup formulation were >10 mL/kg in mice and rats. No clinical signs were observed at these acute doses.

In repeated oral dose toxicity studies over 5 weeks, mice tolerated 200 mg/kg [no observed adverse effect level (NOAEL)]. At 2000 mg/kg, mortality was high. The few surviving mice showed a reversible increase in liver weight and serum cholesterol. Rats tolerated 25 mg/kg over 26 or 100 weeks, while at 500 mg/kg, convulsions and deaths occurred. The centrilobular hepatocytes were enlarged due to vacuolic change. Another 2-year study confirmed that doses up to 100 mg/kg are well-tolerated, while at 400 mg/kg, convulsions occurred sporadically in a few rats. Dogs tolerated 100 mg/kg (NOAEL) orally over 2 years. Brommy syrup (0.8 mg/mL) was well-tolerated up to 20 mg/kg in rats, but there was a reversible centrilobular simple fatty change of liver. An IM dose of 8 mg injectable solution was locally and systemically well-tolerated in dogs treated for 6 weeks.

Brommy was neither embryotoxic nor teratogenic in segment II at oral doses up to 300 mg/kg (rat) and 200 mg/kg (rabbit). Fertility was not impaired in segment II at doses up to 300 mg/kg. The “NOAEL” during the peri- and postnatal development in segment II was 25 mg/kg.

A single intra-articular injection of 4 mg Brommy was well-tolerated in rabbits and dogs. The lesions after IM injection in rabbits compared well with those after physiological saline solution. In vitro, 1 mL injectable solution showed a hemolytic action when mixed with 0.1 mL human blood.

In 2 studies (Ames and micronucleus tests), Brommy had no mutagenic potential. Brommy did not show a tumorigenic potential in the 2-year studies on rats given up to 400 mg/kg and on dogs given up to 100 mg/kg.

Brommy administration

Should be taken with food.

References

1. EPA DSStox. "Bromhexine: DSSTox provides a high quality public chemistry resource for supporting improved predictive toxicology.". https://comptox.epa.gov/dashboard/ds... (accessed September 17, 2018).

Reviews

The results of a survey conducted on ndrugs.com for Brommy are given in detail below. The results of the survey conducted are based on the impressions and views of the website users and consumers taking Brommy. We implore you to kindly base your medical condition or therapeutic choices on the result or test conducted by a physician or licensed medical practitioners.

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Information checked by Dr. Sachin Kumar, MD Pharmacology