Adverse, drug reactions dosage form

Any dosage-form can produce adverse drug reactions. Hence, a regular feed back of relevant information on such adverse reactions from the medical practitioners to the appropriate regulatory authorities and the concerned manufacturers would not only help to intensify better safety measures but also widen the scope to improve drug-design by meticulous research scientists all over the world. 

The appropriate use of antiepileptic drugs requires a thorough understanding of their clinical pharmacology, e.g., mechanism of action, pharmacokinetics, adverse reaction, dosage forms, and drug interactions. 

Other. Most drug substances used to manufacture dosage forms are solids. It is therefore necessary to consider other properties that may affect the bioavailability with the possibility of eliciting adverse reactions. These parameters, which should be adequately addressed both in the specifications and in the characterization/structure elucidation section, include the nature and extent of solvation, the possibility of different polymorphs, and particle size. 

The IND application allows the FDA to determine whether it is probably safe to administer a particular drug product to humans and whether the anticipated specified therapeutic action is likely to outweigh anticipated adverse reactions. Probability and likelihood are the province of the statistician. It is not possible for statistical manipulations of recorded events to prove absolutely that any predicted event will actually occur. Statistics can provide an estimation of the likelihood that a particular treatment previously administered in a particular dosage form at a particular level will continue to yield similar therapeutic effects and side effects in a similar population. 

Both the inhalant (aerosol) and parenteral dosage forms of pentamidine iselhionale arc sterile lyophilized powders that must be made up as sterile aqueous solutions prior to use. Sterile water fur injection must be used to reconstitute the aerosol, to avoid precipitation of the pentamidine salt. Adverse reactions to the drug ate common. These include cough and bmnehospasm (inhalation) and hypertension and hypoglycemia (injection). 

Aldehydes, even in trace amounts, are often found to adversely affect the stability and efficacy of drugs via direct reaction with the active pharmaceutical ingredient (API). Formaldehyde, acetaldehyde, furfural, and glyoxal are the aldehydes most often responsible for stability issues in drug products. In solid dosage forms, these aldehydes are sufficiently small to be mobile enough to react effectively with APIs. 

Cranberry juice has long been recommended for use in treating and preventing urinary tract infections (UTIs). Clinical studies have confirmed that cranberry juice is beneficial to individuals with frequent UTIs Cranberries inhibit bacteria from attaching to the walls of the urinary tract and prevent certain bacteria from forming dental plaque in the mouth. Cranberry juice is safe for use asa food and for urinary tract health. Cranberry juice and capsules have no contraindica-tions no known adverse reactions and no drug interactions The recommended dosage is9 to 15 capsules a day (400-500 mg/d) or 4 to 8 ounces of juice per day. (See Chap. 6 for more information.)... 

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