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What are the possible side effects of Mebaal?
Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.
Common side effects may include:
nausea, vomiting, diarrhea;
loss of appetite; or
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
Side effects of Mebaal in details
The most frequent adverse effect of nondepolarizing blocking agents as a class consists of an extension of the pharmacological action beyond the time needed for surgery and anesthesia. This effect may vary from skeletal muscle weakness to profound and prolonged skeletal muscle paralysis resulting in respiratory insufficiency and apnea which require manual or mechanical ventilation until recovery is judged to be clinically adequate. Inadequate reversal of neuromuscular block from Mebaal (doxacurium chloride) is possible, as with all nondepolarizing agents. Prolonged neuromuscular block and inadequate reversal may lead to postoperative complications.
Observed in Clinical Trials
Adverse experiences were uncommon among the 1034 surgical patients and volunteers who received Mebaal (doxacurium chloride) and other drugs in US clinical studies in the course of a wide variety of procedures conducted during balanced or inhalational anesthesia. The following adverse experiences were reported in patients administered Mebaal (doxacurium chloride) (all events judged by investigators during the clinical trials to have a possible causal relationship):
Incidence Greater than 1%
Incidence Less than 1%
|Cardiovascular:*||Hypotension,† flushing,† ventricular fibrillation, myocardial infarction|
|Dermatological:||Urticaria, injection site reaction|
|Nonspecific:||Difficult neuromuscular block reversal, prolonged drug effect, fever|
|* Reports of ventricular fibrillation (n = 1) and myocardial infarction (n = 1) were limited to ASA Class 3-4 patients undergoing cardiac surgery (n = 142). |
† 0.3% incidence. All other reactions unmarked were ≤ 0.1%.
Observed During Clinical Practice
There have been post-marketing reports of severe allergic reactions (anaphylactic and anaphylactoid reactions) with the use of neuromuscular blocking agents of which Mebaal (doxacurium chloride) is a member. These reactions, in some cases, have been life threatening and fatal. Because these reactions were reported voluntarily from a population of uncertain size, it is not possible to reliably estimate their frequency.
What is the most important information I should know about Mebaal?
Follow all directions on your medicine label and package. Tell each of your healthcare providers about all your medical conditions, allergies, and all medicines you use.
Mebaal (doxacurium chloride) is contraindicated in patients with known hypersensitivity to the product and its components. Mebaal (doxacurium chloride) is contraindicated for use in premature infants because the formulation contains benzyl alcohol.
- European Chemicals Agency - ECHA. "mecobalamin: The European Chemicals Agency (ECHA) is an agency of the European Union which is the driving force among regulatory authorities in implementing the EU's groundbreaking chemicals legislation for the benefit of human health and the environment as well as for innovation and competitiveness.". https://echa.europa.eu/ (accessed September 17, 2018).
- ClinicalTrials.gov. "Mecobalamin". https://clinicaltrials.gov/ (accessed September 17, 2018).
- WHO ATC. "ATC Code: In the World Health Organization (WHO) Anatomical Therapeutic Chemical (ATC) classification system, the active substances are divided into different groups according to the organ or system on which they act and their therapeutic, pharmacological and chemical properties.". https://www.whocc.no/atc_ddd_index/ (accessed September 17, 2018).
ReviewsThe results of a survey conducted on ndrugs.com for Mebaal 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 Mebaal. 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.
Consumer reported side effectsNo survey data has been collected yet
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Information checked by Dr. Sachin Kumar, MD Pharmacology