Phentermine topiramate strengths and weaknesses of a person

By | 02.05.2018

In situations where immediate termination of Qsymia is medically required, appropriate monitoring is recommended. Advise patients of the following: Phentermine should not be administered during or within 14 days following the use of drugs with MAO-inhibiting activity. Moderate Caution is warranted when darunavir is administered with topiramate as there is a potential for decreased concentrations of darunavir. Reports of sleep disorders were typically characterized as insomnia, and occurred in 6.

However, get medical help right away if you notice any symptoms of a serious allergic reaction , including: This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist. Call your doctor for medical advice about side effects. In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at Before taking this medication , tell your doctor or pharmacist if you are allergic to it; or to any other sympathomimetic amines including decongestants such as pseudoephedrine , stimulants such as amphetamine , appetite suppressants such as diethylpropion ; or if you have any other allergies.

This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details. Before using this medication, tell your doctor or pharmacist your medical history, especially of: This drug may make you dizzy or drowsy or blur your vision. Alcohol or marijuana can make you more dizzy or drowsy.

Do not drive, use machinery, or do anything that needs alertness or clear vision until you can do it safely. Talk to your doctor if you are using marijuana. This medication may make you sweat less, making you more likely to get heat stroke. Avoid doing things that may cause you to overheat, such as hard work or exercise in hot weather, or using hot tubs. When the weather is hot, drink a lot of fluids and dress lightly.

If you overheat, quickly look for a place to cool down and rest. If you have diabetes , check your blood sugar regularly as directed and share the results with your doctor. Your doctor may need to adjust your diabetes medication during treatment with this medication. Before having surgery, tell your doctor or dentist about all the products you use including prescription drugs , nonprescription drugs, and herbal products. Older adults may be more sensitive to the side effects of this drug, especially dizziness and high blood pressure.

Dizziness can increase the risk of falling. Children may be more sensitive to the side effects of this drug, especially weakened bones, slowed growth rate, and decreased sweating. Consult your doctor or pharmacist for more details. This medication must not be used during pregnancy. It may harm an unborn baby. Discuss the use of reliable forms of birth control with your doctor. If you become pregnant or think you may be pregnant, tell your doctor right away.

You will need to have a negative pregnancy test before starting this medication. You will also need to take a pregnancy test every month while on this medication. Topiramate passes into breast milk. It is unknown if phentermine passes into breast milk; however, similar drugs pass into breast milk. This medication may have undesirable effects on a nursing infant. Therefore, breast-feeding while using this medication is not recommended. Consult your doctor before breast-feeding.

Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Do not start, stop, or change the dosage of any medicines without your doctor's approval. Taking MAO inhibitors with this medication may cause a serious possibly fatal drug interaction. Avoid taking MAO inhibitors isocarboxazid , linezolid , methylene blue, moclobemide, phenelzine , procarbazine , rasagiline , safinamide, selegiline, tranylcypromine during treatment with this medication.

Most MAO inhibitors should also not be taken for two weeks before treatment with this medication. Ask your doctor when to start or stop taking this medication. Some products that may interact with this drug include: Tell your doctor or pharmacist if you are taking other products that cause drowsiness including alcohol, marijuana , antihistamines such as cetirizine , diphenhydramine , drugs for sleep or anxiety such as alprazolam , diazepam , zolpidem , muscle relaxants, and narcotic pain relievers such as codeine.

Some products have ingredients that could raise your heart rate or blood pressure. Tell your pharmacist what products you are using, and ask how to use them safely especially cough -and-cold products or diet aids. If you are taking hormonal birth control such as pills, patch, or ring with this medication, tell your doctor if you have any new spotting or breakthrough bleeding. Caffeine can increase the side effects of this medication.

Avoid drinking large amounts of beverages containing caffeine coffee, tea, colas , eating large amounts of chocolate , or taking nonprescription products that contain caffeine. Make sure laboratory personnel and all your doctors know you use this drug. If someone has overdosed and has serious symptoms such as passing out or trouble breathing , call Otherwise, call a poison control center right away.

US residents can call their local poison control center at Canada residents can call a provincial poison control center. Symptoms of overdose may include: Do not share this medication with others. It is against the law. Consult your doctor for more details. If you miss a dose, skip the missed dose and resume your usual dosing schedule.

Do not double the dose to catch up. Store at room temperature away from light and moisture. Do not store in the bathroom. Females of reproductive potential should use effective contraception during Qsymia therapy [see Use In Specific Populations ]. Because of the teratogenic risk associated with Qsymia therapy, Qsymia is available through a limited program under the REMS. Further information, is available at www. A higher percentage of Qsymia-treated overweight and obese adults experienced heart rate increases from baseline of more than 5, 10, 15, and 20 beats per minute bpm compared to placebo-treated overweight and obese adults.

Table 2 provides the numbers and percentages of patients with elevations in heart rate in clinical studies of up to one year. The clinical significance of a heart rate elevation with Qsymia treatment is unclear, especially for patients with cardiac and cerebrovascular disease such as patients with a history of myocardial infarction or stroke in the previous 6 months, life-threatening arrhythmias, or congestive heart failure. Regular measurement of resting heart rate is recommended for all patients taking Qsymia, especially patients with cardiac or cerebrovascular disease or when initiating or increasing the dose of Qsymia.

Qsymia has not been studied in patients with recent or unstable cardiac or cerebrovascular disease and therefore use is not recommended. Patients should inform healthcare providers of palpitations or feelings of a racing heartbeat while at rest during Qsymia treatment. For patients who experience a sustained increase in resting heart rate while taking Qsymia, the dose should be reduced or Qsymia discontinued. Antiepileptic drugs AEDs , including topiramate, a component of Qsymia, increase the risk of suicidal thoughts or behavior in patients taking these drugs for any indication.

Discontinue Qsymia in patients who experience suicidal thoughts or behaviors. Pooled analyses of placebo-controlled clinical studies monotherapy and adjunctive therapy, median treatment duration 12 weeks of 11 different AEDs across several indications showed that patients randomized to one of the AEDs had approximately twice the risk adjusted Relative Risk 1. The estimated incidence rate of suicidal behavior or ideation among 27, AED-treated patients was 0.

There were four suicides in AED-treated patients in the trials and none in placebo treated patients, but the number is too small to allow any conclusion about AED effect on suicide. The increased risk of suicidal thoughts or behavior with AEDs was observed as early as 1 week after starting drug treatment with AEDs and persisted for the duration of treatment assessed. Because most trials included in the analysis did not extend beyond 24 weeks, the risk of suicidal thoughts or behavior beyond 24 weeks could not be assessed.

The risk of suicidal thoughts or behavior was generally consistent among drugs in the data analyzed. The finding of increased risk with AEDs of varying mechanisms of action and across a range of indications suggests that the risk applies to all AEDs used for any indication. The risk did not vary substantially by age 5 to years in the clinical trials analyzed. A syndrome consisting of acute myopia associated with secondary angle closure glaucoma has been reported in patients treated with topiramate, a component of Qsymia.

Ophthalmologic findings can include myopia, anterior chamber shallowing, ocular hyperemia redness , and increased intraocular pressure. Mydriasis may or may not be present. This syndrome may be associated with supraciliary effusion resulting in anterior displacement of the lens and iris , with secondary angle closure glaucoma. Symptoms typically occur within 1 month of initiating treatment with topiramate but may occur at any time during therapy.

The primary treatment to reverse symptoms is immediate discontinuation of Qsymia. Elevated intraocular pressure of any etiology , if left untreated, can lead to serious adverse events including permanent loss of vision. Qsymia can cause mood disorders, including depression, and anxiety, as well as insomnia. Patients with a history of depression may be at increased risk of recurrent depression or other mood disorders while taking Qsymia.

For clinically significant or persistent symptoms consider dose reduction or withdrawal of Qsymia. If patients have symptoms of suicidal ideation or behavior, discontinue Qsymia. Qsymia can cause cognitive dysfunction e. Since Qsymia has the potential to impair cognitive function, patients should be cautioned about operating hazardous machinery, including automobiles, until they are reasonably certain Qsymia therapy does not affect them adversely. If cognitive dysfunction persists consider dose reduction or withdrawal of Qsymia for symptoms that are moderate to severe, bothersome, or those which fail to resolve with dose reduction.

Conditions or therapies that predispose to acidosis i. Concomitant use of Qsymia and a carbonic anhydrase inhibitor e. Therefore, if Qsymia is given concomitantly with another carbonic anhydrase inhibitor to a patient with a predisposing condition for metabolic acidosis the patient should be monitored for the appearance or worsening of metabolic acidosis. Some manifestations of acute or chronic metabolic acidosis may include hyperventilation , nonspecific symptoms such as fatigue and anorexia , or more severe sequelae including cardiac arrhythmias or stupor.

The effect of Qsymia on growth and bone-related sequelae has not been systematically investigated in long-term, placebo-controlled trials. Measurement of electrolytes including serum bicarbonate prior to starting Qsymia and during Qsymia treatment is recommended. In Qsymia clinical trials, the peak reduction in serum bicarbonate occurred by week 4, and in most subjects there was a correction of bicarbonate by week 56, without any change to study drug.

However, if persistent metabolic acidosis develops while taking Qsymia, reduce the dose or discontinue Qsymia. Qsymia can cause an increase in serum creatinine. Peak increases in serum creatinine were observed after 4 to 8 weeks of treatment. On average, serum creatinine gradually declined but remained elevated over baseline creatinine values. Elevations in serum creatinine often signify a decrease in renal function, but the cause for Qsymia-associated changes in serum creatinine has not been definitively established.

Therefore, measurement of serum creatinine prior to starting Qsymia and during Qsymia treatment is recommended. Qsymia has not been studied in combination with insulin. Measurement of blood glucose levels prior to starting Qsymia and during Qsymia treatment is recommended in patients with type 2 diabetes. Decreases in medication doses for antidiabetic medications which are non-glucose-dependent should be considered to mitigate the risk of hypoglycemia.

If a patient develops hypoglycemia after starting Qsymia, appropriate changes should be made to the antidiabetic drug regimen. In hypertensive patients being treated with antihypertensive medications, weight loss may increase the risk of hypotension , and associated symptoms including dizziness, lightheadedness , and syncope. Measurement of blood pressure prior to starting Qsymia and during Qsymia treatment is recommended in patients being treated for hypertension.

If a patient develops symptoms associated with low blood pressure after starting Qsymia, appropriate changes should be made to the antihypertensive drug regimen. The concomitant use of alcohol or central nervous system CNS depressant drugs e. Therefore, avoid concomitant use of alcohol with Qsymia. Abrupt withdrawal of topiramate, a component of Qsymia, has been associated with seizures in individuals without a history of seizures or epilepsy.

In situations where immediate termination of Qsymia is medically required, appropriate monitoring is recommended. Phentermine and topiramate, the components of Qsymia, are cleared by renal excretion. Adjust dose of Qsymia for both patient populations. Qsymia has not been studied in patients with end-stage renal disease on dialysis.

In patients with mild Child-Pugh score 5 -6 or moderate Child-Pugh score 7 -9 hepatic impairment, exposure to phentermine was higher compared to healthy volunteers. Adjust dose of Qsymia for patients with moderate hepatic impairment. Qsymia has not been studied in patients with severe hepatic impairment Child-Pugh score 10 Use of Qsymia has been associated with kidney stone formation. Topiramate, a component of Qsymia, inhibits carbonic anhydrase activity and promotes kidney stone formation by reducing urinary citrate excretion and increasing urine pH.

Avoid the use of Qsymia with other drugs that inhibit carbonic anhydrase e. Use of topiramate by patients on a ketogenic diet may also result in a physiological environment that increases the likelihood of kidney stone formation. Oligohidrosis decreased sweating , infrequently resulting in hospitalization, has been reported in association with the use of topiramate, a component of Qsymia.

Decreased sweating and an elevation in body temperature above normal characterized these cases. Some of the cases have been reported with topiramate after exposure to elevated environmental temperatures. Patients treated with Qsymia should be advised to monitor for decreased sweating and increased body temperature during physical activity, especially in hot weather.

Caution should be used when Qsymia is prescribed with other drugs that predispose patients to heat-related disorders; these drugs include, but are not limited to, other carbonic anhydrase inhibitors and drugs with anticholinergic activity. Qsymia can increase the risk of hypokalemia through its inhibition of carbonic anhydrase activity. In addition, when Qsymia is used in conjunction with non- potassium sparing diuretics such as furosemide loop diuretic or hydrochlorothiazide thiazide-like diuretic this may further potentiate potassium- wasting.

Qsymia was associated with changes in several clinical laboratory analytes in randomized, double-blind, placebo-controlled studies. Qsymia is indicated for chronic weight management in conjunction with a reduced- calorie diet and increased physical activity. Qsymia is only available through certified pharmacies that are enrolled in the Qsymia certified pharmacy network. Advise patients on how to access Qsymia through certified pharmacies. Additional information may be obtained via the website www.

Advise patients to tell healthcare provider s about all medications, nutritional supplements, and vitamins including any weight loss products that are being taken or may be taken while on Qsymia. If an increase in Qsymia dose is prescribed after medical evaluation, advise patients to increase the dose of Qsymia as follows:. Oligohidrosis decreased sweating has been reported in association with the use of topiramate, a component of Qsymia. The following data are based on findings in studies performed individually with phentermine or topiramate, Qsymia's two active ingredients.

Phentermine was not mutagenic or clastogenic with or without metabolic activation in the Ames bacterial mutagenicity assay, a chromosomal aberration test in Chinese hamster lung CHL-K1 cells, or an in vivo micronucleus assay. No animal studies have been conducted with phentermine to determine the potential for impairment of fertility. Topiramate did not demonstrate genotoxic potential when tested in a battery of in vitro and in vivo assays.

Topiramate was not mutagenic in the Ames test or the in vitro mouse lymphoma assay; it did not increase unscheduled DNA synthesis in rat hepatocytes in vitro; and it did not increase chromosomal aberrations in human lymphocytes in vitro or in rat bone marrow in vivo. The relevance of this finding to human carcinogenic risk is uncertain. Qsymia is contraindicated in pregnant women.

The use of Qsymia can cause fetal harm and weight loss offers no potential benefit to a pregnant woman. Available epidemiologic data indicate an increased risk in oral clefts cleft lip with or without cleft palate with first trimester exposure to topiramate, a component of Qsymia. When multiple species of pregnant animals received topiramate at clinically relevant doses, structural malformations, including craniofacial defects, and reduced fetal weights occurred in offspring.

If this drug is used during pregnancy, or if a patient becomes pregnant while taking this drug, treatment should be discontinued immediately and the patient should be apprised of the potential hazard to a fetus. There is a Qsymia Pregnancy Surveillance Program to monitor maternal-fetal outcomes of pregnancies that occur during Qsymia therapy. Healthcare providers and patients are encouraged to report pregnancies by calling Oral clefts occur from the fifth through the ninth week of gestation.

The lip is formed between the beginning of the fifth week to the seventh week of gestation, and the palate is formed between the beginning of the sixth week through the ninth week of gestation. A minimum weight gain, and no weight loss, is currently recommended for all pregnant women, including those who are already overweight or obese, due to the obligatory weight gain that occurs in maternal tissues during pregnancy. Qsymia can cause metabolic acidosis. Data evaluating the risk of major congenital malformations and oral clefts with topiramate a component of Qsymia exposure during pregnancy is available from the North American Anti-Epileptic Drug NAAED Pregnancy Registry and from several larger retrospective epidemiologic studies.

Larger retrospective epidemiology studies showed that topiramate monotherapy exposure in pregnancy is associated with an approximately two to five-fold increased risk of oral clefts Table 5. Embryo-fetal development studies have been conducted in rats and rabbits with combination phentermine and topiramate treatment. Phentermine and topiramate co-administered to rats during the period of organogenesis caused reduced fetal body weights but did not cause fetal malformations at the maximum dose of 3.

In a similar study in rabbits, no effects on embryo-fetal development were observed at approximately 0. Significantly lower maternal body weight gain was recorded at these doses in rats and rabbits. A pre-and post-natal development study was conducted in rats with combination phentermine and topiramate treatment. There were no adverse maternal or offspring effects in rats treated throughout organogenesis and lactation with 1.

Treatment with higher doses of Offspring effects included lower pup survival after birth, increased limb and tail malformations, reduced pup body weight and delayed growth, development, and sexual maturation without affecting learning, memory, or fertility and reproduction. The limb and tail malformations were consistent with results of animal studies conducted with topiramate alone [see Nonclinical Toxicology ]. Animal reproduction studies have not been conducted with phentermine.

Topiramate causes developmental toxicity, including teratogenicity, at clinically relevant doses [see Nonclinical Toxicology ]. The effect of Qsymia on labor and delivery in humans is unknown. Qsymia may be present in human milk because topiramate and amphetamines phentermine has pharmacologic activity and a chemical structure similar to amphetamines are excreted in human milk. Because of the potential for serious adverse reactions in nursing infants, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.

Safety and effectiveness of Qsymia in pediatric patients below the age of 18 years have not been established and the use of Qsymia is not recommended in pediatric patients. Serious adverse reactions seen in pediatric patients using topiramate, a component of Qsymia, include acute angle glaucoma, oligohidrosis and hyperthermia , metabolic acidosis, cognitive and neuropsychiatric reactions, hyperammonemia and encephalopathy , and kidney stones. Juvenile animal studies have not been conducted with Qsymia.

No overall differences in safety or effectiveness were observed between these subjects and younger subjects, but greater sensitivity of some older individuals cannot be ruled out. Clinical studies of Qsymia did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy.

Females who become pregnant during Qsymia therapy should stop Qsymia treatment immediately and notify their healthcare provider. Contraception Females of reproductive potential should use effective contraception during Qsymia therapy. Compared to healthy volunteers, patients with moderate and severe renal impairment as estimated by the Cockcroft-Gault equation had higher phentermine and topiramate exposures.

No dose adjustments are necessary in patients with mild renal impairment. In patients with mild Child-Pugh 5 -6 and moderate Child-Pugh 7 -9 hepatic impairment, exposure to phentermine was higher compared to healthy volunteers. Exposure to topiramate, a component of Qsymia, was similar among patients with mild and moderate hepatic impairment and healthy volunteers. No dose adjustments are necessary in patients with mild hepatic impairment.

In patients with moderate hepatic impairment, the dose should not exceed Qsymia 7. In the event of a significant overdose with Qsymia, if the ingestion is recent, the stomach should be emptied immediately by gastric lavage or by induction of emesis. Appropriate supportive treatment should be provided according to the patient's clinical signs and symptoms. Acute overdose of phentermine may be associated with restlessness, tremor , hyperreflexia, rapid respiration , confusion, aggressiveness, hallucinations, and panic states.

Fatigue and depression usually follow the central stimulation. Cardiovascular effects include arrhythmia , hypertension or hypotension , and circulatory collapse. Gastrointestinal symptoms include nausea, vomiting, diarrhea, and abdominal cramps. Fatal poisoning usually terminates in convulsions and coma. Manifestations of chronic intoxication with anorectic drugs include severe dermatoses, marked insomnia, irritability, hyperactivity , and personality changes. A severe manifestation of chronic intoxication is psychosis , often clinically indistinguishable from schizophrenia.

Management of acute phentermine intoxication is largely symptomatic and includes lavage and sedation with a barbiturate. Acidification of the urine increases phentermine excretion. Intravenous phentolamine has been suggested for possible acute, severe hypertension, if this complicates phentermine overdosage. Topiramate overdose has resulted in severe metabolic acidosis. Other signs and symptoms include convulsions, drowsiness, speech disturbance, blurred vision, diplopia , mentation impaired, lethargy , abnormal coordination, stupor, hypotension, abdominal pain, agitation, dizziness, and depression.

The clinical consequences were not severe in most cases, but deaths have been reported after poly- drug overdoses involving gram amounts of topiramate. A patient who ingested a dose between 96 and grams topiramate was admitted to hospital with coma lasting 20 to 24 hours followed by full recovery after 3 to 4 days.

Activated charcoal has been shown to adsorb topiramate in vitro. Hemodialysis is an effective means of removing topiramate from the body. The exact mechanism of action is not known. The precise mechanism of action of topiramate on chronic weight management is not known. Typical actions of amphetamines include central nervous system stimulation and elevation of blood pressure. Tachyphylaxis and tolerance have been demonstrated with all drugs of this class in which these phenomena have been looked for.

A total of 54 healthy subjects were administered Qsymia 7. Phentermine pharmacokinetics is approximately dose-proportional from Qsymia 3. Topiramate pharmacokinetics is approximately dose-proportional from Qsymia 3. The fraction bound decreased as blood topiramate increased. Phentermine has two metabolic pathways, namely p-hydroxylation on the aromatic ring and N-oxidation on the aliphatic side chain. The mean phentermine terminal half-life is about 20 hours. Topiramate does not show extensive metabolism.

The mean topiramate terminal half-life is about 65 hours. Creatinine clearance was estimated from serum creatinine based on the Cockcroft-Gault equation. An inverse relationship between phentermine or topiramate Cmax or AUC and creatinine clearance was observed. Pharmacokinetics of topiramate was not affected in patients with mild and moderate hepatic impairment when compared with healthy volunteers. Phentermine is not a P- glycoprotein substrate. However, topiramate is a mild inhibitor of CYP2C Topiramate is a mild inducer of CYP3A4.

Topiramate is not a P-glycoprotein substrate. Potential interactions between topiramate and standard antiepileptic AED drugs were assessed in controlled clinical pharmacokinetic studies in patients with epilepsy. The effects of these interactions on mean plasma AUCs are summarized in Table 8. In Table 8, the second column AED concentration describes what happens to the concentration of the AED listed in the first column when topiramate is added.

The third column topiramate concentration describes how the co-administration of a drug listed in the first column modifies the concentration of topiramate in experimental settings when topiramate was given alone. The clinical relevance of this observation has not been established. A drug-drug interaction study conducted in healthy volunteers evaluated the steady-state pharmacokinetics of hydrochlorothiazide HCTZ 25 mg q24h and topiramate 96 mg q12h when administered alone and concomitantly.

The clinical significance of this change is unknown. The steady-state pharmacokinetics of HCTZ were not significantly influenced by the concomitant administration of topiramate. Clinical laboratory results indicated decreases in serum potassium after topiramate or HCTZ administration, which were greater when HCTZ and topiramate were administered in combination. A drug-drug interaction study conducted in healthy volunteers evaluated the steady-state pharmacokinetics of topiramate and pioglitazone when administered alone and concomitantly.

This finding was not statistically significant. The clinical significance of these findings is not known. When topiramate is added to pioglitazone therapy or pioglitazone is added to topiramate therapy, careful attention should be given to the routine monitoring of patients for adequate control of their diabetic disease state. The steady-state pharmacokinetics of topiramate were unaffected by concomitant administration of glyburide. Lithium levels should be monitored when co-administered with high-dose topiramate.

The pharmacokinetics of a single dose of haloperidol 5 mg were not affected following multiple dosing of topiramate mg every 12 hours in 13 healthy adults 6 males, 7 females. Some subjects may experience a large increase in amitriptyline concentration in the presence of topiramate and any adjustments in amitriptyline dose should be made according to the patient's clinical response and not on the basis of plasma levels.

Multiple dosing of topiramate mg every 12 hrs in 24 healthy volunteers 14 males, 10 females did not affect the pharmacokinetics of single-dose sumatriptan either orally mg or subcutaneously 6 mg. No alterations of 9-hydroxyrisperidone levels were observed. There were no clinically significant changes in the systemic exposure of risperidone plus 9-hydroxyrisperidone or of topiramate; therefore, this interaction is not likely to be of clinical significance.

Multiple dosing of venlafaxine mg extended release did not affect the pharmacokinetics of topiramate. Topiramate, a component of Qsymia, causes developmental toxicity, including teratogenicity, in multiple animal species at clinically relevant doses. When female rats were treated during the latter part of gestation and throughout lactation 0. The effect of Qsymia on weight loss in conjunction with reduced caloric intake and increased physical activity was studied in 2 randomized, double-blind, placebo-controlled studies in obese patients Study 1 and in obese and overweight patients with two or more significant co-morbidities Study 2.

Both studies had a 4-week titration period, followed by 52 weeks of treatment. There were 2 co-primary efficacy outcomes measured after 1 year of treatment Week Patients with type 2 diabetes were excluded from participating in Study 1. The average weight and BMI of patients at the start of the study was kg and Table 9 provides the results for the weight loss at 1 year in Studies 1 and 2. After 1 year of treatment with Qsymia, all dose levels resulted in statistically significant weight loss compared to placebo Table 9, Figures 1 and 2.

Type 1 error was controlled across all pairwise treatment comparisons. Study 2 Percent Weight Change. The changes in cardiovascular , metabolic, and anthropometric risk factors associated with obesity from Study 1 and 2 are presented in Table 10 and LS Mean Qsymia 3. LS Mean Qsymia 7. Among the subjects with type 2 diabetes treated in study 2, reductions in HbA1c from baseline 6. Read this Medication Guide before you start taking Qsymia and each time you get a refill.

There may be new information. This information does not take the place of talking to your healthcare provider about your medical condition or treatment. If you have any questions about Qsymia, talk to your healthcare provider or pharmacist. If you become pregnant while taking Qsymia, stop taking Qsymia immediately, and tell your healthcare provider right away. Healthcare providers and patients should report all cases of pregnancy to:.

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