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The pharmacokinetics of phentermine are dose-dependent. [6] [6] Peak concentrations of phentermine are reached 6 hours following oral administration of a dose of 15 mg. [6] The steady-state levels of phentermine with continuous administration have been found to be around 200 ng/mL in clinical studies. [6]
Fenfluramine as a single drug was first introduced in the 1970s, but was not popular because it only temporarily reduced weight. [1] A 1984 study found a weight loss of 7.5 kg on average in 24 weeks, as compared to 4.4 kg under placebo. [4] It sold modestly until the 1990s, when it was combined with phentermine and heavily marketed. [1]
amitriptyline – tricyclic antidepressant used to treat separation anxiety, excessive grooming dogs and cats; amlodipine – calcium channel blocker used to decrease blood pressure; amoxicillin – antibacterial; apomorphine – emetic (used to induce vomiting) artificial tears – lubricant eye drops used as a tear supplement
Phentermine and topiramate was developed by Vivus, a California pharmaceutical company. In December 2009, Vivus, Inc. submitted a new drug application (NDA) to the FDA and on 1 March 2010, Vivus, Inc. announced that the FDA accepted the NDA for review.
The drug or other substance has a currently [1] accepted medical use in treatment in the United States. Abuse of the drug or other substance may lead to moderate or low physical dependence or high psychological dependence. The complete list of Schedule III substances is as follows.
Fenfluramine is indicated for the treatment of seizures associated with Dravet syndrome and Lennox–Gastaut syndrome in people age two and older. [3] [7] [4]Dravet syndrome is a life-threatening, rare and chronic form of epilepsy. [7]
Under the act, supplements are regulated by the FDA for Good Manufacturing Practices under 21 CFR Part 111. [2] The act was intended to exempt the dietary and herbal supplement industry from most FDA drug regulations, allowing them to be sold and marketed without scientific backing for their health and medical claims. [3]
Threshold dose is the minimum dose of drug that triggers minimal detectable biological effect in an animal. [1] At extremely low doses, biological responses are absent for some of the drugs. The increase in dose above threshold dose induces an increase in the percentage of biological responses. [ 2 ]
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