In this case, the 2 drugs distribute dffferently and are not substitutable.įor more information on bioequivalence, check out The Orange Book published by the FDA. The ester can cross the blood brain barrier and acts centrally as a minor tranquilizer. The salt form cannot cross the blood brain barrier, so it is used peripherally as an anti-histamine. ADHD or attention deficit hyperactivity disorder is a common disease especially among children where they start to have anxiety over small issues, depression, overthinking, etc. It is suitable for the age group above three years. It is marketed as the hydrochloride salt under the trade name Atarax® and is also marketed as the pamoate ester under the trade name Vistaril®. Amphetamine is a medicine that is used for the treatment of ADHD in people. EACH TABLET CONTAINS: 5 mg 7.5 mg 10 mg 12.5 mg 15 mg 20 mg 30 mg DEXTROAMPHETAMI NE Saccharate 1.25 mg 1.875 mg 2.5 mg 3.125 mg 3. The prescriber might have changed it.Īnother example is the drug hydroxyzine. A single-entity amphetamine product combining the neutral sulfate salts of dextroamphetamine and amphetamine, with the dextro isomer of amphetamine saccharate and d, l-amphetamine aspartate monohydrate. The d-amphetamine salts combo prescription you have now may be an extended release formulation and so the effects are very different from the single ingredient d-amphetamine that you had before. Amphetamine Salt Combo (20mg) Oral Side Effects by Likelihood and Severity COMMON side effects If experienced, these tend to have a Severe expression i Sorry, we have no data available. Therefore the two formulations are not bioequivalent and are not substitutable. However it’s not true in all cases.Ī controlled release formulation (such as sustained release, extended release, delayed release, long-acting, etc.) releases the drug slower, get absorbed slower and reaches the peak plasma level slower than the regular formulation. In most cases, the drug itself and its salt are similar enough that there is no major therapeutic difference and are considered bioequivalent. So they have different effects on the body. In general, a drug and its salt form will have different dissolution rates and therefore will be absorbed at dfferent rates, distributed differently, metabolized differently and eliminated differently from the body. The basis of bioequivalence is determined by the kinetics of absorption, distribution, metabolism and elimination from the body. The former is a single ingredient product while the latter is a mixture of salts. In your situation, dextroamphetamine and dextroamphetamine salts combo are 2 different drugs. Therefore the 2 drugs not only must be chemically equivalent, but also therapeutically equivalent. In order to substitute lawfully, the 2 drugs must be bioequivalent and in the same dosage form.
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