Ambroxol Actions

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Actions of Ambroxol in details

The action of the drug on the human body is called Pharmacodynamics in Medical terminology. To produce its effect and to change the pathological process that is happening the body and to reduce the symptom or cure the disease, the medicine has to function in a specific way. The changes it does to the body at cellular level gives the desired result of treating a disease. Drugs act by stimulating or inhibiting a receptor or an enzyme or a protein most of the times. Medications are produced in such a way that the ingredients target the specific site and bring about chemical changes in the body that can stop or reverse the chemical reaction which is causing the disease.
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Pharmacology: Preclinically, Ambroxol hydrochloride, the active ingredient of Ambroxol, has been shown to increase respiratory tract secretion. It enhances pulmonary surfactant production and stimulates ciliary activity. These actions result in improved mucus flow and transport (mucociliary clearance). Improvement of mucociliary clearance has been shown in clinical pharmacologic studies. Enhancement of fluid secretion and mucociliary clearance facilitates expectoration, and eases cough.

In patients suffering from COPD, long-term treatment (6 months) with Ambroxol (Ambroxol Retard Capsule 75 mg) resulted in a significant reduction of exacerbations that became evident after 2 months of treatment. Patients in the Ambroxol treatment group lost significantly fewer days through illness and had fewer days when they needed antibiotic therapy. Treatment with Ambroxol Retard also induced a statistically significant improvement of symptoms (difficulty of expectoration, cough, dyspnea, auscultatory signs) compared with placebo.

A local anaesthetic effect of Ambroxol hydrochloride has been observed in the rabbit eye model which may be explained by the sodium-channel blocking properties. It was shown in vitro that Ambroxol hydrochloride blocks cloned neuronal sodium channels; binding was reversible and concentration-dependent.

Cytokine release from blood but also tissue-bound mononuclear and polymorphonuclear cells was found to be significantly reduced by Ambroxol hydrochloride in vitro.

In clinical studies in patients with sore throat, pharyngeal pain and redness was significantly reduced.

Following the administration of Ambroxol, antibiotic concentrations (amoxicilline, cefuroxime, erythromycin) in bronchopulmonary secretions and in the sputum are increased.

Pharmacokinetics: Absorption: Absorption of all immediate release oral forms of Ambroxol hydrochloride is rapid and complete, with dose linearity in the therapeutic range. Maximum plasma levels are reached within 1 to 2.5 hours following oral administration of the immediate-release formulation and after a median of 6.5 hours of the slow-release formulation. The absolute bioavailability after a 30 mg tablet was found to be 79%. The slow-release capsule showed a relative availability of 95% (dose-normalized) in comparison to a daily dose of 60 mg (30 mg twice daily) administered as immediate-release tablet.

Distribution: In the therapeutic range, plasma protein-binding was found to be approximately 90%. Distribution of Ambroxol hydrochloride from blood to tissue is rapid and pronounced, with the highest concentration of the active substance found in the lungs. The volume of distribution following oral administration was estimated to be 552 L.

Metabolism and Elimination: About 30% of an orally administered dose is eliminated via first-pass metabolism.

Studies in human liver microsomes have shown that CYP3A4 is responsible for the metabolism of Ambroxol. Ambroxol hydrochloride is metabolized primarily in the liver by glucuronidation and some cleavage to dibromanthranilic acid (approximately 10% of dose) aside from some minor metabolites.

Ambroxol hydrochloride is eliminated with a terminal elimination half-life of approximately 10 hours. Total clearance is in the range of 660 mL/min, with renal clearance accounting for approximately 83% of the total clearance.

Special Populations: In patients with hepatic dysfunction, elimination of Ambroxol hydrochloride is reduced, resulting in approximately 1.3 to 2-fold higher plasma levels.

Due to the high therapeutic range of Ambroxol hydrochloride, dose adjustments are not necessary.

Others: Age and gender were not found to affect the pharmacokinetics of Ambroxol hydrochloride to a clinically relevant extent and thus there is no necessity for adjustment of dosage regimens.

Food was not found to influence the bioavailability of Ambroxol hydrochloride.

Ambroxol administration

Administration of drug is important to know because the drug absorption and action varies depending on the route and time of administration of the drug. A medicine is prescribed before meals or after meals or along with meals. The specific timing of the drug intake about food is to increase its absorption and thus its efficacy. Few work well when taken in empty stomach and few medications need to be taken 1 or 2 hrs after the meal. A drug can be in the form of a tablet, a capsule which is the oral route of administration and the same can be in IV form which is used in specific cases. Other forms of drug administration can be a suppository in anal route or an inhalation route.
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Should be taken with food.

Ambroxol pharmacology

Pharmacokinetics of a drug can be defined as what body does to the drug after it is taken. The therapeutic result of the medicine depends upon the Pharmacokinetics of the drug. It deals with the time taken for the drug to be absorbed, metabolized, the process and chemical reactions involved in metabolism and about the excretion of the drug. All these factors are essential to deciding on the efficacy of the drug. Based on these pharmacokinetic principles, the ingredients, the Pharmaceutical company decides dose and route of administration. The concentration of the drug at the site of action which is proportional to therapeutic result inside the body depends on various pharmacokinetic reactions that occur in the body.

When Max Pidek Pharmaceuticals administered orally amoxicillin rapidly and completely absorbed from the gastrointestinal tract and is not destroyed in the acidic environment of the stomach. Cmax of amoxicillin in the blood plasma is reached after 1-2 h. When increasing doses of 2 times the concentration also increased by 2 times. In the presence of food in the stomach does not reduce the overall removals. Similar concentrations of amoxicillin reached in the blood when administered orally, IV and IM.

The binding of amoxicillin to plasma proteins is about 20%.

Widely distributed in tissues and body fluids. Reported high concentrations of amoxicillin in the liver.

T1/2 from the plasma is 1-1.5 h. About 60% of the dose adopted by mouth, is excreted unchanged in the urine by glomerular filtration and tubular secretion, with a dose of 250 mg of amoxicillin concentration in urine exceeds 300 micrograms / ml. A number of amoxicillin is determined in feces.

T1/2 for Newborns and the elderly can be longer.

In renal insufficiency T1/2 may be 7-20 hours.

In small quantities amoxicillin penetrates through BBB in inflammation of the pia mater.

amoxicillin is removed by hemodialysis.


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References

  1. EPA DSStox. "Ambroxol: 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 Ambroxol 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 Ambroxol. 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.

User reports

8 consumers reported administration

When best can I take Ambroxol, on an empty stomach, before or after food?
ndrugs.com website users have also released a report stating that Ambroxol should be taken Empty stomach. In any case, this may not be the right description on how you ought to take this Ambroxol. Kindly visit your doctor for more medical advice in this regard. Click here to see other users view on when best the Ambroxol can be taken.
Users%
Empty stomach3
37.5%
Before food2
25.0%
After food2
25.0%
With a meal1
12.5%


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Information checked by Dr. Sachin Kumar, MD Pharmacology

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