QSYMIA (Phentermine,Topiramate) 3.75mg/23mg

QSYMIA (Phentermine,Topiramate) 3.75mg/23mg


QSYMIA (Phentermine,Topiramate) 3.75mg/23mg

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Phentermine/topiramate, sold under the brand name Qsymia, is a combination of phentermine and topiramate used to treat obesity.[1] It is used together with dietary changes and exercise.[2] If less than 3% weight loss is seen after 3 months it is recommended the medication be stopped.[2] The weight loss is modest.[3] Effects on heart related health problems or death is unclear.[2]

Common side effects include tingling, dizziness, trouble sleeping, and constipation.[2] Serious side effects may include suicideabuse.[2] Use is not recommended during pregnancy.[1] Phentermine is a stimulant and appetite suppressant.[3] Topiramate is an anticonvulsant that has weight loss side effects.[3] The exact mechanism of action for both drugs is unknown.[3]

Phentermine/topiramate was approved for medical use in the United States in 2012.[2] Approval was denied in Europe, due to concerns regarding safety

How to use Qsymia

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In clinical trials, people treated with the highest dose of phentermine/topiramate ER in combination with a program of diet and exercise lost 10% to 11% of their body weight compared to 1% to 2% for those who received placebo.[3] In addition, 62% to 70% of subjects receiving the recommended dose or top dose of phentermine/topiramate ER achieved ≥5% weight reduction by week 56 (ITT-LOCF) compared to 17% to 21% of those receiving a placebo.[3]

A Cochrane review on the long-term effects of weight-reducing drugs on people with hypertension found that phentermine/topiramate reduced body weight (when compared to orlistat, and naltrexone/bupropion) and also reduced blood pressure

To prevent kidney stones from forming, drink plenty of liquids while taking this medication unless your doctor instructs you otherwise.

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Adverse effects

In clinical trials, the most common adverse events which occurred at a rate ≥5% and ≥1.5 times placebo included paraesthesia (tingling in fingers/toes), dizziness, altered tasteinsomniaconstipation, and dry mouth.[3]

In the U.S., the drug label contains warnings for increased heart rate, suicidal behavior and ideation, glaucoma, mood and sleep disorders, creatine elevation, and metabolic acidosis. Some of these warnings are based on historical observations in epilepsy patients taking topiramate. The FDA is requiring the company to perform a post-approval cardiovascular outcomes trial, due in part to the observation of increased heart rate in some people taking the drug in clinical trials.


Phentermine and topiramate can cause fetal harm. Data from pregnancy registries and epidemiology studies indicate that a fetus exposed to topiramate in the first trimester of pregnancy has an increased risk of oral clefts (cleft lip with or without cleft palate).[3] If a patient becomes pregnant while taking phentermine/topiramate ER, treatment should be discontinued immediately, and the patient should be apprised of the potential hazard to a fetus. Females of reproductive potential should have a negative pregnancy test before starting phentermine/topiramate ER and monthly thereafter during phentermine/topiramate ER therapy. Females of reproductive potential should use effective contraception during phentermine/topiramate ER therapy.[3]

Risk evaluation and mitigation strategy

Phentermine and topiramate was approved with a risk evaluation and mitigation strategy (REMS) program to ensure that benefits of treatment outweigh the risks.[6] Because of the teratogenic risk associated with phentermine/topiramate ER therapy, phentermine/topiramate ER is distributed via certified pharmacies


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