When a dose is taken in higher dose than the recommended doses, it is called Overdose. Overdose always needs a clinical supervision. Any medicine or drug when consumed in Overdose produces untoward side effects on one or various organs in the body. A medicine is excreted in the kidney or metabolized in the liver most of the times. This process goes without any hurdles when taken in normal dose, but when taken in an overdose, the body is not able to metabolize it or send it out properly which causes the effects of anoverdose.
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No specific overdose symptoms have been reported in man to date.
Based on accidental overdose and/or medication error reports the observed symptoms are consistent with the known side effects of Ambroxol at recommended doses and may need symptomatic treatment.
Ambroxol warnings
Warnings are a mix of Precautions. Contraindications and interactions and serious harmful effects associated with the medicine intake. A diabetic or Hypertensive patient need to be warned about few drug interactions. A known hypersensitivity patient needs to be careful about the reactions or anaphylactic shock. A pregnant woman or a breastfeeding woman should be warned of certain medications. A Hepatitis [liver disease] patient or a cardiac patient should avoid few drugs.
With caution used Ambroxol Lark Laboratories when tachyarrhythmia and other cardiac arrhythmias, arterial hypertension, myocarditis, heart defects, aortic stenosis, diabetes, thyrotoxicosis, glaucoma, acute heart failure (with careful medical supervision).
Increase doses or frequency of receiving albuterol (salbutamol) should be under the supervision of a doctor. Reducing the interval may be only in exceptional cases and should be strictly justified.
In the application of salbutamol there was a risk of hypokalemia, so the period of treatment in patients with severe asthma should monitor the flow levels of potassium in the blood. The risk of hypokalemia increases with hypoxia.
Ambroxol precautions
Certain people who are very sick or very old or who are sensitive show an exacerbation of side effect of the drug which can turn dangerous at times. So, it is very important to remember the precautions while taking the medicine. Pregnancy and Breastfeeding are also special categories wherein extra care or precaution is needed when taking a drug. Few patients may have a hypersensitivity reaction to few medications, and that can be life-threatening rarely. Penicillin hypersensitivity is one example. Diarrhea, rashes are few other symptoms which need a watch. A patient with other co-existing diseases like liver disease, heart disease, kidney disease should take special precautions.
Ambroxol 30-mg tablets contain lactose 684 mg per maximum recommended daily dose (120 mg). Patients with rare hereditary galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take Ambroxol.
Ambroxol liquid (30 mg/5 mL) contains sorbitol 7.4 g per maximum recommended daily dose (20 mL). Patients with rare hereditary fructose intolerance should not take Ambroxol.
There have been very few reports of severe skin lesions eg, Stevens-Johnson syndrome and toxic epidermal necrolysis (TEN) in temporal association with the administration of expectorants eg, Ambroxol. Mostly these could be explained by the severity of the patient's underlying disease and/or concomitant medication. In addition during the early phase of a Stevens-Johnson syndrome or TEN, a patient may first experience non-specific influenza-like prodromes, it is possible that a symptomatic treatment is started with a cough and cold medication.
Therefore, if new skin or mucosal lesions occur, medical advice should be sought immediately and treatment with Ambroxol discontinued as a precaution.
In the presence of impaired renal function, Ambroxol may be used only after consulting a physician.
Effects on the Ability to Drive or Operate Machinery: There is no evidence for an effect on the ability to drive and use machines. Studies on the effects on the ability to drive and use machines have not been performed.
Use in pregnancy & lactation: Ambroxol crosses the placental barrier. Animal studies do not indicate direct or indirect harmful effects with respect to pregnancy, embryonal/foetal development, parturition or postnatal development. Extensive clinical experience after the 28th week of pregnancy has shown no evidence of harmful effects on the foetus. Nonetheless, the usual precautions regarding the use of drugs during pregnancy should be observed. Especially during the 1st trimester, the use of Ambroxol is not recommended.
Ambroxol is excreted in breast milk. Therefore, Ambroxol is not recommended for use in nursing mothers. However, unfavourable effects on breastfed infants would not be expected.
Burnham Center for Chemical Geno. "SID50085991: Aqueous solubility in buffer at pH 7.4". https://pubchem.ncbi.nlm.nih.gov/bio... (accessed September 17, 2018).
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