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The effect of Qsymia on cardiovascular morbidity and mortality has not been established (1). The safety and effectiveness of Qsymia in combination with other products intended for weight loss, including prescription and over-the-counter drugs, and herbal preparations, have not been established (1). Oral contraceptives: Altered exposure may cause irregular bleeding but not increased risk of pregnancy. The safety and effectiveness of Qsymia in combination with other products intended for weight loss, including prescription and over-the-counter drugs and herbal preparations have not been established. Known hypersensitivity or idiosyncrasy to the sympathomimetic amines [see Adverse Reactions (6.2)]. Because of the teratogenic risk associated with Qsymia therapy, Qsymia is available through a limited program under the REMS. 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. 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.
Patients should inform healthcare providers of palpitations or feelings of a racing heartbeat while at rest during Qsymia treatment. 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. 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.
The risk of suicidal thoughts or behavior was generally consistent among drugs in the data 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. For clinically significant or persistent symptoms consider dose reduction or withdrawal of Qsymia. 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. Hyperchloremic, non-anion gap, metabolic acidosis (decreased serum bicarbonate below the normal reference range in the absence of chronic respiratory alkalosis) has been reported in patients treated with Qsymia [see Adverse Reactions (6.1)]. 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. Measurement of electrolytes including serum bicarbonate prior to starting Qsymia and during Qsymia treatment is recommended. In hypertensive patients being treated with antihypertensive medications, weight loss may increase the risk of hypotension, and associated symptoms including dizziness, lightheadedness, and syncope.
Abrupt withdrawal of topiramate, a component of Qsymia, has been associated with seizures in individuals without a history of seizures or epilepsy. 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. Qsymia has not been studied in patients with severe hepatic impairment (Child-Pugh score 10 - 15). Use of topiramate by patients on a ketogenic diet may also result in a physiological environment that increases the likelihood of kidney stone formation.
Increase fluid intake to increase urinary output which can decrease the concentration of substances involved in kidney stone formation [see Adverse Reactions (6.1)]. Oligohidrosis (decreased sweating), infrequently resulting in hospitalization, has been reported in association with the use of topiramate, a component of Qsymia. Patients treated with Qsymia should be advised to monitor for decreased sweating and increased body temperature during physical activity, especially in hot weather.
Qsymia can increase the risk of hypokalemia through its inhibition of carbonic anhydrase activity. Qsymia was associated with changes in several clinical laboratory analytes in randomized, double-blind, placebo-controlled studies.

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical studies of another drug and may not reflect the rates observed in practice. Adverse reactions reported in greater than or equal to 2% of Qsymia-treated patients and more frequently than in the placebo group are shown in Table 3. In the 1-year controlled trials of Qsymia, there was a dose-related increase from baseline, peaking between Week 4 to 8, which declined but remained elevated over baseline over 1 year of treatment. The following adverse reactions have been reported during post approval use of phentermine and topiramate, the components of Qsymia. Use of phentermine is contraindicated during or within 14 days following the administration of monoamine oxidase inhibitors because of the risk of hypertensive crisis. Although this study did not specifically address the impact of the interaction on contraceptive efficacy, an increased risk of pregnancy is not anticipated. However, irregular bleeding (spotting) may occur more frequently due to both the increased exposure to the progestin and lower exposure to the estrogen, which tends to stabilize the endometrium.
Specific drug interaction studies of Qsymia and alcohol or other CNS depressant drugs have not been performed. Concurrent use of Qsymia with non-potassium sparing diuretics may potentiate the potassium-wasting action of these diuretics. Concomitant administration of phenytoin or carbamazepine with topiramate in patients with epilepsy, decreased plasma concentrations of topiramate by 48% and 40%, respectively, when compared to topiramate given alone [see Clinical Pharmacology (12.3)].
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Rather, this fictional story is based on the results that some people who have used these products have achieved. Qsymia is available through a limited program under a Risk Evaluation and Mitigation Strategy (REMS) (5.1).
Caution patients about operating automobiles or hazardous machinery when starting treatment (5.6).
Data from pregnancy registries and epidemiology studies indicate that a fetus exposed to topiramate, a component of Qsymia, in the first trimester of pregnancy has an increased risk of oral clefts (cleft lip with or without cleft palate).
Table 2 provides the numbers and percentages of patients with elevations in heart rate in clinical studies of up to one year. Qsymia has not been studied in patients with recent or unstable cardiac or cerebrovascular disease and therefore use is not recommended. For patients who experience a sustained increase in resting heart rate while taking Qsymia, the dose should be reduced or Qsymia discontinued.
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 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.
Patients with a history of depression may be at increased risk of recurrent depression or other mood disorders while taking Qsymia.
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. 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.
Measurement of blood pressure prior to starting Qsymia and during Qsymia treatment is recommended in patients being treated for hypertension. In situations where immediate termination of Qsymia is medically required, appropriate monitoring is recommended. Topiramate, a component of Qsymia, inhibits carbonic anhydrase activity and promotes kidney stone formation by reducing urinary citrate excretion and increasing urine pH. Decreased sweating and an elevation in body temperature above normal characterized these cases. 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. 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. Of the subjects who experienced persistent low serum potassium, 88% were receiving treatment with a non-potassium sparing diuretic.
The most common adverse reactions that led to discontinuation of treatment are shown in Table 4.
Because these reactions are reported voluntarily from a population of uncertain size it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
The primary determinant of contraceptive efficacy is the progestin component of the combination oral contraceptive, so higher exposure to the progestin would not be expected to be deleterious.
Patients should be informed not to discontinue their combination oral contraceptive if spotting occurs, but to notify their health care provider if the spotting is troubling to them.
Concomitant administration of hydrochlorothiazide alone with topiramate alone has been shown to increase the Cmax and AUC of topiramate by 27% and 29%, respectively.

That link should take you to our review page of some of the most popular weight loss pills that are well rated for their effectiveness and rapid weight reduction results. The results portrayed in the story and in the comments are illustrative, and may not be the results that you achieve with these products. The closest no prescription equivalent weight loss pills like Phentermine Adipex fat burning appetite suppressant slimming tablets that truly work! A QSYMIA (phentermine and topiramate extended-release) capsules, for oral use, CIV Initial U.S. A BMI conversion chart (Table 1) based on height [inches (in) or centimeters (cm)] and weight [pounds (lb) or kilograms (kg)] is provided below. If Qsymia is used during pregnancy or if a patient becomes pregnant while taking Qsymia, treatment should be discontinued immediately, and the patient should be apprised of the potential hazard to a fetus. 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 risk did not vary substantially by age (5 to 100 years) in the clinical trials analyzed.
Ophthalmologic findings can include myopia, anterior chamber shallowing, ocular hyperemia (redness), and increased intraocular pressure. The majority of these mood and sleep disorders resolved spontaneously, or resolved upon discontinuation of dosing [see Adverse Reactions (6.1)].
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. The effect of Qsymia on growth and bone-related sequelae has not been systematically investigated in long-term, placebo-controlled trials. However, if persistent metabolic acidosis develops while taking Qsymia, reduce the dose or discontinue Qsymia. On average, serum creatinine gradually declined but remained elevated over baseline creatinine values.
If a patient develops symptoms associated with low blood pressure after starting Qsymia, appropriate changes should be made to the antihypertensive drug regimen. Some of the cases have been reported with topiramate after exposure to elevated environmental temperatures. The majority of these events first occurred within the initial 12 weeks of drug therapy; however, in some patients, events were reported later in the course of treatment. These events typically began within the first 4 weeks of treatment, had a median duration of approximately 28 days or less, and were reversible upon discontinuation of treatment; however, individual patients did experience events later in treatment, and events of longer duration.
Therefore, if Qsymia is used with alcohol or other CNS depressants, the patient should be counseled regarding possible increased risk of CNS depression or side effects. This page receives compensation for clicks on or purchase of products featured on this site. Find good thermogenic and rapid metabolism boosters to help you melt away body fats quicker. Females of reproductive potential should have a negative pregnancy test before starting Qsymia and monthly thereafter during Qsymia therapy.
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. Only Qsymia-treated patients discontinued treatment due to these events (1% for Paraesthesia and 0.6% for dysgeusia). Website dedicated to reviewing the most powerful OTC herbal Phentermine replacement supplements to help you burn fat faster with weight management products you can buy online from the United States of America (US), Canada, UK, Ireland, New Zealand (NZ), Australia (AU), Switzerland, Saudi Arabia, Dubai (UAE), South Africa, and from other countries as well. This syndrome may be associated with supraciliary effusion resulting in anterior displacement of the lens and iris, with secondary angle closure glaucoma.
Therefore, measurement of serum creatinine prior to starting Qsymia and during Qsymia treatment is recommended. Symptoms typically occur within 1 month of initiating treatment with topiramate but may occur at any time during therapy. If persistent elevations in creatinine occur while taking Qsymia, reduce the dose or discontinue Qsymia [see Adverse Reactions (6.1)]. The majority of these events first occurred within the initial 12 weeks of drug therapy; however, in some patients, events were reported later in the course of treatments. In the Qsymia clinical trials, the overall prevalence of mood and sleep adverse reactions was approximately twice as great in patients with a history of depression compared to patients without a history of depression; however, the proportion of patients on active treatment versus placebo who reported mood and sleep adverse reactions was similar in these two subgroups. Elevated intraocular pressure of any etiology, if left untreated, can lead to serious adverse events including permanent loss of vision. Occurrence of depression-related events was more frequent in patients with a past history of depression across all treatment groups. However, the placebo-adjusted difference in incidence of these events remained constant between groups regardless of previous depression history.

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