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The U. Sealed bottles labeled as montelukast sodium tablets, 10 milligram, count bottle from Camber were found to instead contain 90 tablets of Losartan Potassium Tablets, 50 mg.

If you are a consumer or patient please visit this version. Reserve use for patients who have an inadequate response or intolerance to alternative therapies 1. Patients with both asthma and allergic rhinitis should take only one dose daily in the evening 2. Do not abruptly substitute montelukast sodium for inhaled or oral corticosteroids 5. These events have been sometimes associated with the reduction of oral corticosteroid therapy 5. Serious neuropsychiatric NP events have been reported with the use of montelukast sodium.

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Health Conditions Chevron. Respiratory Health Chevron. Asthma Chevron. One form of montelukast, a medication commonly prescribed to treat asthma symptoms, has been voluntarily recalled for a potentially dangerous labeling mix-up , according to a statement from the Food and Drug Administration FDA. Specifically, the recall affects pill bottles of 10 milligram montelukast tablets a generic version of Singulair manufactured by Camber Pharmaceuticals, the statement says. Instead of montelukast, these were found to contain losartan, a medication prescribed to treat high blood pressure. The affected montelukast bottles are from lot number MON and have an expiration date of December 31, Losartan tablets are white and oval shaped, with an "I" on one side and a "5" on the other. Montelukast is used to ease some symptoms of asthma, which can be serious and even life-threatening if left untreated. Those symptoms include wheezing, difficulty breathing, chest tightness, and coughing.

Therefore, continue to monitor and provide supportive care until symptoms resolve. Re-evaluate the benefits and risks of restarting treatment with sodium if such events occur.

If you are a consumer or patient please visit this version. Methocarbamol tablets USP a carbamate derivative of guaifenesin, is a central nervous system CNS depressant with sedative and musculoskeletal relaxant properties. The chemical name of methocarbamol is 3- 2-methoxyphenoxy -1,2-propanediol 1-carbamate and has the empirical formula C 11 H 15 NO 5. Its molecular weight is The structural formula is shown below. Methocarbamol is a white powder, sparingly soluble in water and chloroform, soluble in alcohol only with heating and propylene glycol, and insoluble in benzene and n-hexane.

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Help control the symptoms of allergic rhinitis such as sneezing, stuffy nose, runny nose, and itching of the nose. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. Montelukast sodium USP is a hygroscopic, optically active, white or almost white powder. General information about the safe and effective use of montelukast sodium tablets Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. The following doses are recommended: For adults and adolescents 15 years of age and older: one 10 mg tablet. Do not take 2 doses at the same time. Instead of montelukast, these were found to contain losartan, a medication prescribed to treat high blood pressure. Maintenance dosage: 2 tablets q. View Package Photos. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. Carcinogenesis,Mutagenesis,Impairment of Fertility Long-term studies to evaluate the carcinogenic potential of methocarbamol have not been performed. Do not give montelukast sodium tablets to other people even if they have the same symptoms you have.

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Safety and effectiveness in pediatric patients younger than 6 months of age with perennial allergic rhinitis have not been established. If you are a consumer or patient please visit this version. They are supplied as follows:. The relationship between these observations and the clinical benefits of montelukast noted in the clinical trials is not known [see Clinical Studies 14 ]. Product Characteristics. Pharmacokinetics In healthy volunteers, the plasma clearance of methocarbamol ranges between 0. However, data from a clinical drug-drug interaction study involving montelukast and rosiglitazone a probe substrate representative of drugs primarily metabolized by CYP2C8 in 12 healthy individuals demonstrated that the pharmacokinetics of rosiglitazone are not altered when the drugs are coadministered, indicating that montelukast does not inhibit CYP2C8 in vivo. Prevent asthma attacks and for the long-term treatment of asthma in adults and adolescents ages 15 years and older. Four of the five trials showed a significant reduction in daytime nasal symptoms scores with montelukast sodium 10 mg tablets compared with placebo. This prescription medication a. Drug-Drug Interactions Theophylline, Prednisone, and Prednisolone: Montelukast sodium has been administered with other therapies routinely used in the prophylaxis and chronic treatment of asthma with no apparent increase in adverse reactions. The affected montelukast bottles are from lot number MON and have an expiration date of December 31,