Qnexa
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Qnexa
Phentermine/topiramate, sold under the brand name Qsymia, is a combination drug of phentermine and topiramate used to treat obesity. It is used together with dietary changes and exercise. If less than 3% weight loss is seen after 3 months it is recommended the medication be stopped. The weight loss is modest.https://www.qsymia.com/pdf/prescribing-information.pdf Effects on heart related health problems or death is unclear. Common side effects include tingling, dizziness, trouble sleeping, and constipation. Serious side effects may include suicide, abuse. Use is not recommended during pregnancy. Phentermine is a stimulant and appetite suppressant. Topiramate is an anticonvulsant that has weight loss side effects. The exact mechanism of action for both drugs is unknown. Phentermine/topiramate was approved for medical use in the United States in 2012. In October 2012, approval was denied in Europe, due to concerns regarding safety. Medical uses In clinical trials, people tr ...
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Vivus
Vivus () is a small pharmaceutical company headquartered in Campbell, California, working in obesity, sleep, and sexual health. Vivus is developing an erectile dysfunction drug, Avanafil, that has completed Phase 3 clinical trials. The drug has been approved for use by the FDA, and will be sold under the trademark name Stendra. Stendra is the first and only oral ED treatment approved to be taken approximately 15 minutes before sexual activity. A documentary movie " Orgasm Inc." was made at Vivus in 2009 to document the process of creating a treatment for female sexual arousal disorder (FSD). Vivus also developed an obesity drug, Qnexa (now called Qsymia), a combination of phentermine and topiramate, two existing weight-loss drugs. On July 17, 2012, The U.S. Food and Drug Administration approved Qsymia (phentermine and topiramate extended-release), made by Vivus, as an addition to a reduced-calorie diet and exercise for chronic weight management. The drug was approved for use ...
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Phentermine
Phentermine ( phenyl- tertiary-butyl amine), with several brand names including Ionamin and Sentis, is a medication used together with diet and exercise to treat obesity. It is taken by mouth for up to a few weeks at a time, after which the benefits subside. It is also available as the combination phentermine/topiramate. Common side effects include a fast heart beat, high blood pressure, trouble sleeping, dizziness, and restlessness. Serious side effects may include abuse but do not include pulmonary hypertension, valvular heart disease as the latter were caused by the fenfluramine component of the fen-phen drug combination. Use is not recommended during pregnancy or breastfeeding, or with SSRIs or MAO inhibitors. It works mainly as an appetite suppressant, likely as a result of being a CNS stimulant. Chemically, phentermine is a substituted amphetamine. Phentermine was approved for medical use in the United States in 1959. It is available as a generic medication. In 2020, i ...
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Phentermine
Phentermine ( phenyl- tertiary-butyl amine), with several brand names including Ionamin and Sentis, is a medication used together with diet and exercise to treat obesity. It is taken by mouth for up to a few weeks at a time, after which the benefits subside. It is also available as the combination phentermine/topiramate. Common side effects include a fast heart beat, high blood pressure, trouble sleeping, dizziness, and restlessness. Serious side effects may include abuse but do not include pulmonary hypertension, valvular heart disease as the latter were caused by the fenfluramine component of the fen-phen drug combination. Use is not recommended during pregnancy or breastfeeding, or with SSRIs or MAO inhibitors. It works mainly as an appetite suppressant, likely as a result of being a CNS stimulant. Chemically, phentermine is a substituted amphetamine. Phentermine was approved for medical use in the United States in 1959. It is available as a generic medication. In 2020, i ...
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Appetite Suppressant
An anorectic or anorexic is a drug which reduces appetite, resulting in lower food consumption, leading to weight loss. By contrast, an appetite stimulant is referred to as orexigenic. The term is (from the Greek ''ἀν-'' (an-) = "without" and ''ὄρεξις'' (órexis) = "appetite"), and such drugs are also known as anorexigenic, anorexiant, or appetite suppressant. History Used on a short-term basis clinically to treat obesity, some appetite suppressants are also available over-the-counter. Most common natural appetite suppressants are based on ''Hoodia'', a genus of 13 species in the flowering plant family Apocynaceae, under the subfamily Asclepiadoideae. Several appetite suppressants are based on a mix of natural ingredients, mostly using green tea as its basis, in combination with other plant extracts such as fucoxanthin, found naturally in seaweed. Drugs of this class are frequently stimulants of the phenethylamine family, related to amphetamine. The German and Finnish ...
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Hypertension
Hypertension (HTN or HT), also known as high blood pressure (HBP), is a long-term medical condition in which the blood pressure in the arteries is persistently elevated. High blood pressure usually does not cause symptoms. Long-term high blood pressure, however, is a major risk factor for stroke, coronary artery disease, heart failure, atrial fibrillation, peripheral arterial disease, vision loss, chronic kidney disease, and dementia. Hypertension is a major cause of premature death worldwide. High blood pressure is classified as primary (essential) hypertension or secondary hypertension. About 90–95% of cases are primary, defined as high blood pressure due to nonspecific lifestyle and genetic factors. Lifestyle factors that increase the risk include excess salt in the diet, excess body weight, smoking, and alcohol use. The remaining 5–10% of cases are categorized as secondary high blood pressure, defined as high blood pressure due to an identifiable cause, such ...
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Birth Defect
A birth defect, also known as a congenital disorder, is an abnormal condition that is present at birth regardless of its cause. Birth defects may result in disabilities that may be physical, intellectual, or developmental. The disabilities can range from mild to severe. Birth defects are divided into two main types: structural disorders in which problems are seen with the shape of a body part and functional disorders in which problems exist with how a body part works. Functional disorders include metabolic and degenerative disorders. Some birth defects include both structural and functional disorders. Birth defects may result from genetic or chromosomal disorders, exposure to certain medications or chemicals, or certain infections during pregnancy. Risk factors include folate deficiency, drinking alcohol or smoking during pregnancy, poorly controlled diabetes, and a mother over the age of 35 years old. Many are believed to involve multiple factors. Birth defects may be visi ...
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Complete Response Letter
In United States pharmaceutical regulatory practice, a Complete Response Letter (CRL), or more rarely, a 314.110 letter, is a regulatory action by the Food and Drug Administration in response to a New Drug Application, New Drug Application, Amended New Drug Application or Biologics license application, Biologics License Application, indicating that the application will not be approved in its present form. CRLs replaced Approvable letter, approvable letters in 2018. Background Under the Prescription Drug User Fee Act, the Food and Drug Administration has a limited timespan (known as the PDUFA date) to decide a New Drug Application, New Drug Application, Amended New Drug Application or Biologics license application, Biologics License Application. The FDA may either approve the application or issue a Complete Response Letter. Grounds behind issuing a CRL may include Drug labelling, labelling issues, Good manufacturing practice, current Good Manufacturing Practice concerns or concerns ...
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Sympathomimetic
Sympathomimetic drugs (also known as adrenergic drugs and adrenergic amines) are stimulant compounds which mimic the effects of endogenous agonists of the sympathetic nervous system. Examples of sympathomimetic effects include increases in heart rate, force of cardiac contraction, and blood pressure. The primary endogenous agonists of the sympathetic nervous system are the catecholamines (i.e., epinephrine drenaline norepinephrine oradrenaline and dopamine), which function as both neurotransmitters and hormones. Sympathomimetic drugs are used to treat cardiac arrest and low blood pressure, or even delay premature labor, among other things. These drugs can act through several mechanisms, such as directly activating postsynaptic receptors, blocking breakdown and reuptake of certain neurotransmitters, or stimulating production and release of catecholamines. Mechanisms of action The mechanisms of sympathomimetic drugs can be direct-acting (direct interaction between drug ...
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Risk Evaluation And Mitigation Strategy
Risk Evaluation and Mitigation Strategies (REMS) is a program of the US Food and Drug Administration for the monitoring of medications with a high potential for serious adverse effects. REMS applies only to specific prescription drugs, but can apply to brand name or generic drugs. The REMS program was formalized in 2007. The FDA determines as part of the drug approvals process that a REMS is necessary, and the drug company develops and maintains the individual program. REMS applies only to specific prescription drugs, but can apply to brand name or generic drugs. REMS for generic drugs may be created in collaboration with the manufacture of the brand name drug. The FDA may remove the REMS requirement if it is found to not improve patient safety. The REMS program developed out of previous systems dating back to the 1980s for monitoring the use of a small number of high-risk drugs such as the Accutane, which causes serious birth defects, Clozaril, which can cause agranulocytosis, a ...
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Dry Mouth
Xerostomia, also known as dry mouth, is dryness in the mouth, which may be associated with a change in the composition of saliva, or reduced salivary flow, or have no identifiable cause. This symptom is very common and is often seen as a side effect of many types of medication. It is more common in older people (mostly because this group tend to take several medications) and in persons who breathe through their mouths. Dehydration, radiotherapy involving the salivary glands, chemotherapy and several diseases can cause reduced salivation (hyposalivation), or a change in saliva consistency and hence a complaint of xerostomia. Sometimes there is no identifiable cause, and there may sometimes be a psychogenic reason for the complaint. Definition Xerostomia is the subjective sensation of dry mouth, which is often (but not always) associated with hypofunction of the salivary glands. The term is derived from the Greek words ξηρός (''xeros'') meaning "dry" and στόμα (''stoma'') ...
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Constipation
Constipation is a bowel dysfunction that makes bowel movements infrequent or hard to pass. The stool is often hard and dry. Other symptoms may include abdominal pain, bloating, and feeling as if one has not completely passed the bowel movement. Complications from constipation may include hemorrhoids, anal fissure or fecal impaction. The normal frequency of bowel movements in adults is between three per day and three per week. Babies often have three to four bowel movements per day while young children typically have two to three per day. Constipation has many causes. Common causes include slow movement of stool within the colon, irritable bowel syndrome, and pelvic floor disorders. Underlying associated diseases include hypothyroidism, diabetes, Parkinson's disease, celiac disease, non-celiac gluten sensitivity, colon cancer, diverticulitis, and inflammatory bowel disease. Medications associated with constipation include opioids, certain antacids, calcium channel blockers, ...
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