Dysgeusia, also known as parageusia, is a distortion of the sense of taste.Dysgeusia is also often associated with ageusia, which is the complete lack of taste, and hypogeusia, which is a decrease in taste sensitivity. The chemical name of phentermine hydrochloride is ,-dimethylphenethylamine hydrochloride. Learn all about lithium-ion battery recycling. ' Assess the risk of abuse prior to prescribing Qsymia as part of a chronic weight management program. After 56 weeks of treatment with Qsymia, all dose levels resulted in statistically significant reduction in BMI compared to placebo (see Table 14, Figure 3). 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 exact mechanism of action is not known. Patients on a ketogenic diet may be at increased risk for kidney stone formation. A patient who ingested a dose between 96 and 110 gm topiramate was admitted to hospital with coma lasting 20 to 24 hours followed by full recovery after 3 to 4 days. In Study 1, patients with obesity (BMI greater than or equal to 35 kg/m 2) were randomized to receive 1 year of treatment with placebo (N=514), Qsymia 3.75 mg/23 mg (N=241), or Qsymia 15 mg/92 mg (N=512) in a 2:1:2 ratio. The risk of hypoglycemia may be lowered by a reduction of the dosage of insulin and/or insulin secretagogues. Those who have a checking or savings account, but also use financial alternatives like check cashing services are considered underbanked. Slowing of growth. Both studies had a 4-week titration period, followed by 52 weeks of treatment. Tell your healthcare provider if symptoms occur. Since symptoms of CO poisoning are like the flu, you might not even know you're in danger at first. 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. Compared to healthy volunteers with normal renal function, patients with moderate and severe renal impairment as estimated by the Cockcroft-Gault equation had higher exposures to phentermine and topiramate. A total of 54 healthy subjects were administered Qsymia 7.5 mg/46 mg at steady state and then titrated to Qsymia 22.5 mg/138 mg at steady state. Use effective birth control (contraception) consistently while taking Qsymia. Increased ratio of urinary calcium/citrate increases the risk of kidney stones and/or nephrocalcinosis. You and your healthcare provider should decide if you will take Qsymia or breastfeed. Table 8 describes the effect of phentermine/topiramate on the pharmacokinetics of co-administered drugs. Qsymia has been associated with kidney stone formation [see Adverse Reactions (6.1)] . What should I tell my healthcare provider before taking Qsymia? However, structural malformations, including craniofacial defects and reduced fetal weights occurred in offspring of multiple species of pregnant animals administered topiramate at clinically relevant doses (see Data) . Table 7 displays clinically significant drug interactions with Qsymia. Abrupt withdrawal of topiramate has been associated with seizures in individuals without a history of seizures or epilepsy. Concentration, memory, and speech difficulties. The following important adverse reactions are described elsewhere in the labeling: 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. Prop 30 is supported by a coalition including CalFire Firefighters, the American Lung Association, environmental organizations, electrical workers and businesses that want to improve Californias air quality by fighting and preventing wildfires and reducing air pollution from vehicles. A pre- and post-natal development study was conducted in rats with combination phentermine and topiramate treatment. Measure blood glucose levels prior to starting Qsymia and during Qsymia treatment in patients with type 2 diabetes on antidiabetic medication. Ophthalmologic findings can include myopia, mydriasis, anterior chamber shallowing, ocular hyperemia (redness), choroidal detachments, retinal pigment epithelial detachments, macular striae, and increased intraocular pressure. Rats were administered oral doses of 3, 10, and 30 mg/kg/day phentermine for 2 years. Inform patients that Qsymia can increase the risk of mood changes, sleep disorders, depression, and suicidal ideation. are pregnant, planning to become pregnant, or become pregnant during Qsymia treatment. Serious skin reactions (Stevens-Johnson Syndrome [SJS] and Toxic Epidermal Necrolysis [TEN]) have been reported in patients receiving topiramate. Read this Medication Guide before you start taking Qsymia and each time you get a refill. Inform patients who can become pregnant that Qsymia can cause fetal harm and patients should avoid getting pregnant while taking Qsymia [see Warnings and Precautions (5.1), Drug Interactions (7), Use in Specific Populations (8.3)]. Phentermine has a known potential for abuse. 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. In Table 10, the second column (AED concentration) describes what happens to the concentration of the AED listed in the first column when topiramate is added. Inform patients about the signs of serious skin reactions. In a 56-week study, average height increased from baseline in both Qsymia- and placebo-treated patients; however, a lower height velocity of -1.3 to -1.4 cm/year was observed in Qsymia-treated compared to placebo-treated patients. Phentermine is not an inhibitor of CYP isozymes CYP1A2, CYP2C9, CYP2C19, CYP2D6, CYP2E1, and CYP3A4, and is not an inhibitor of monoamine oxidases. Advise patients to tell their healthcare provider(s) about any changes in attention, concentration, memory, difficulty finding words, or other cognitive functions. Phentermine is not a P-glycoprotein substrate. In a 56-week study, average height increased from baseline in both Qsymia- and placebo-treated patients; however, a lower height velocity of -1.3 to -1.4 cm/year was observed in Qsymia-treated compared to placebo-treated patients. Adults with an initial body mass index (BMI) of: The effect of Qsymia on cardiovascular morbidity and mortality has not been established. The primary treatment to reverse symptoms is discontinuation of Qsymia as rapidly as possible [see Warnings and Precautions (5.12)] . Advise patients that Qsymia is only available through certified pharmacies that are enrolled in the Qsymia certified pharmacy network. No evidence of carcinogenicity was seen in rats following oral administration of topiramate for 2 years at doses up to 120 mg/kg (approximately 4 to 10 times the MRHD of Qsymia based on AUC estimates). Hemodialysis is an effective means of removing topiramate from the body. The recommended dosage of Qsymia in patients with mild renal impairment (CrCl greater or equal to 50 and less than 80 mL/min) is the same as the recommended dosage for patients with normal renal function. Upon dosing phentermine 15 mg/topiramate 100 mg fixed dose combination capsule to steady state, the mean topiramate accumulation ratios for AUC and C max are both approximately 4.0. 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. Instruct patients on the dosage titration schedule of Qsymia. Qsymia IS A REGISTERED TRADEMARK OF VIVUS LLC, Qsymia Phentermine is 17.5% plasma protein bound. Package insert / prescribing information The clinical significance of this change is unknown. Table 5 and Table 6 provide the numbers and percentages of adult and pediatric patients, respectively, with elevations in heart rate in clinical studies of up to one year. Pooled analyses of 199 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 1.8, 95% CI 1.2, 2.7) of suicidal thinking or behavior compared to patients randomized to placebo. JPMorgan Chase has reached a milestone five years in the making the bank says it is now routing all inquiries from third-party apps and services to access customer data through its secure application programming interface instead of allowing these services to collect data through screen scraping. Inform patients not to discontinue their combination oral contraceptive if spotting occurs, but to notify their healthcare provider if the spotting is troubling to them. No patient had a BMD Z-score that went below -2.0 during the trial. Typical actions of amphetamines include central nervous system stimulation and elevation of blood pressure. Its structural formula is: Topiramate is 2,3:4,5-di-O-isopropylidene--D-fructopyranose sulfamate. Keep Qsymia in a safe place, to protect it from theft. 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 Antiepileptic Drug (NAAED) Pregnancy Registry and from several larger retrospective epidemiologic studies. Topiramate is a white to off-white crystalline powder with a bitter taste. The clinical relevance of these observations is unknown. Rapid titration or high initial doses of Qsymia may be associated with higher rates of cognitive events such as attention, memory, and language/word-finding difficulties [see Adverse Reactions (6.1)] . Figure 3. Psychiatric: suicidal ideation, suicidal behavior, Ophthalmic: acute angle closure glaucoma, increased intraocular pressure, Cardiovascular: elevation of blood pressure, ischemic events, Central Nervous System: euphoria, psychosis, tremor, Reproductive: changes in libido, impotence, Dermatologic: bullous skin reactions (including erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis), pemphigus, Hepatic: hepatic failure (including fatalities), hepatitis, Metabolic: hyperammonemia with or without encephalopathy has been reported with concomitant valproic acid [see Drug Interactions (7)], hypothermia. If you become pregnant while taking Qsymia, stop taking Qsymia immediately and tell your healthcare provider right away. Acute overdose of phentermine may be associated with restlessness, tremor, hyperreflexia, rapid respiration, confusion, aggressiveness, hallucinations, and panic states. Three Americans found dead at a Sandals Resort in the Bahamas in May also died of carbon monoxide poisoning, autopsy and toxicology reports showed. Topiramate inhibits carbonic anhydrase activity and promotes kidney stone formation by reducing urinary citrate excretion and increasing urine pH. Advise patients to report symptoms of severe and persistent eye pain or significant changes in their vision to their healthcare provider(s) [see Warnings and Precautions (5.4)] . Compared to healthy volunteers, phentermine AUC 0-inf was 91%, 45%, and 22% higher in patients with severe, moderate, and mild renal impairment, respectively; phentermine C max was 2% to 15% higher. Manifestations of chronic intoxication with anorectic drugs include severe dermatoses, marked insomnia, irritability, hyperactivity, and personality changes. Multiple dosing of topiramate (150 mg/day) in healthy volunteers did not affect the pharmacokinetics of venlafaxine or O-desmethyl venlafaxine. Qsymia can cause mood disorders, including depression and anxiety, as well as insomnia. Qsymia is indicated as an adjunct to a reduced-calorie diet and increased physical activity for chronic weight management in: Select adult patients for Qsymia treatment based on BMI [see Indications and Usage (1)] . any sudden decrease in vision, with or without eye pain and redness. Table 14 provides results for BMI reduction at Week 56 in Study 3. Inform patients that use of Qsymia has been associated with kidney stone formation. Qsymia Risk Evaluation and Mitigation Strategy (REMS). The easiest way to lookup drug information, identify pills, check interactions and set up your own personal medication records. The incidence of hyperammonemia in pediatric patients 12 to 17 years of age in clinical trials of another condition was 26% in patients taking topiramate at 100 mg/day (1.1 times the maximum recommended dosage of Qsymia) and 14% in patients taking topiramate at 50 mg/day (0.6 times the maximum recommended dosage of Qsymia), compared to 9% in patients taking placebo. 30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE, UNIT-DOSE, 14 CAPSULE, EXTENDED RELEASE in 1 BOTTLE, UNIT-DOSE. Avoid Qsymia in this patient population [see Dosage and Administration (2.5) and Clinical Pharmacology (12.3)] . Conditions or therapies that predispose to acidosis (i.e., renal disease, severe respiratory disorders, status epilepticus, diarrhea, surgery, or ketogenic diet) may be additive to the bicarbonate lowering effects of Qsymia. Qsymia has not been studied in patients with recent or unstable cardiac or cerebrovascular disease and therefore use is not recommended. At the beginning of the study the average weight and BMI of patients was 116 kg and 42 kg/m 2, respectively. 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. The effect of topiramate-induced metabolic acidosis has not been studied in pregnancy; however, metabolic acidosis in pregnancy (due to other causes) can cause decreased fetal growth, decreased fetal oxygenation, and fetal death, and may affect the fetus' ability to tolerate labor. JPMorgan Chase has reached a milestone five years in the making the bank says it is now routing all inquiries from third-party apps and services to access customer data through its secure application programming interface instead of allowing these services to collect data through screen scraping. Netflix adds more than 2.4 million subscribers. Antiepileptic drugs (AEDs), including topiramate, increase the risk of suicidal thoughts or behavior in patients taking these drugs for any indication. What is the most important information I should know about Qsymia. Avoid use of Qsymia in patients with severe hepatic impairment (Child-Pugh score 10 - 15). In the 1-year controlled trials of Qsymia in adults, the incidence of persistent decreases in serum bicarbonate below the normal range (levels of less than 21 mEq/L at 2 consecutive visits or at the final visit) was 6.4% for Qsymia 7.5 mg/46 mg and 12.8% for Qsymia 15 mg/92 mg, compared to 2.1% for placebo. A statistically significant greater proportion of the patients randomized to Qsymia than placebo achieved 5% and 10% weight loss. Chronic metabolic acidosis in pediatric patients may also reduce growth rates, which may decrease the maximal height achieved. A poison is a product or substance used in the wrong amount, by the wrong person, at the wrong time. Follow Jamaican news online for free and stay informed on what's happening in the Caribbean Clinical studies of Qsymia did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Qsymia can be taken with or without food. Tachyphylaxis and tolerance have been demonstrated with drugs in this class. Qsymia can cause cognitive dysfunction (e.g., impairment of concentration/attention, difficulty with memory, and speech or language problems, particularly word-finding difficulties). A syndrome consisting of acute myopia associated with secondary angle closure glaucoma has been reported in patients treated with topiramate. Other signs and symptoms include convulsions, drowsiness, speech disturbance, blurred vision, diplopia, impaired mentation, lethargy, abnormal coordination, stupor, hypotension, abdominal pain, agitation, dizziness, and depression. What are the possible side effects of Qsymia? Serum creatinine values declined but remained elevated over baseline over 1 year of treatment. See Table 2 for BMI percentiles by age and sex for pediatric patients aged 12 years and older. Discontinue Qsymia if patients have symptoms of suicidal ideation or behavior [see Warnings and Precautions (5.3)] . It is not known if Qsymia changes your risk of heart problems or stroke or of death due to heart problems or stroke. In a pediatric clinical trial, higher proportions of Qsymia-treated patients reported one or more adverse reactions related to mood (e.g., depression, anxiety) and sleep disorders (e.g., insomnia) compared to placebo-treated patients (See Table 4). There may be new information. The glomerular filtration rate (GFR) of these participants was assessed via iohexol clearance. Professional academic writers. About Our Coalition. Advise patients that weight loss may increase the risk of hypotension. No animal studies have been conducted with phentermine to determine the potential for impairment of fertility. Call the National Button Battery Ingestion Hotline (800) 498-8666 and go to the nearest emergency department immediately. In addition, when Qsymia is used in conjunction with non-potassium sparing diuretics this may further potentiate potassium-wasting. Qsymia is associated with a reduction in height velocity (centimeters of height gained per year) in obese pediatric patients 12 to 17 years of age. 11.25 mg/69 mg (phentermine 11.25 mg and topiramate 69 mg) (equivalent to 14.0 mg of Phentermine Hydrochloride USP). During the study, a well-balanced, reduced-calorie diet to result in an approximate 500 kcal/day decrease in caloric intake was recommended to all patients and patients were offered nutritional and lifestyle modification counseling. A single-dose, open-label study was conducted to evaluate the pharmacokinetics of Qsymia 15 mg/92 mg in adult patients with varying degrees of chronic renal impairment compared to healthy volunteers with normal renal function. No alterations of 9-hydroxyrisperidone levels were observed. 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. Patients on concomitant medications that predispose them to heat-related disorders may be at increased risk. 3.75 mg/23 mg - purple cap imprinted with VIVUS and purple body imprinted with 3.75/23, 7.5 mg/46 mg - purple cap imprinted with VIVUS and yellow body imprinted with 7.5/46, 11.25 mg/69 mg - yellow cap imprinted with VIVUS and yellow body imprinted with 11.25/69, 15 mg/92 mg - yellow cap imprinted with VIVUS and white body imprinted with 15/92, Taking or within 14 days of stopping a monoamine oxidase inhibitors, With known hypersensitivity to phentermine, topiramate or other component of Qsymia, or idiosyncrasy to the sympathomimetic amines, For topiramate, abrupt discontinuation has been associated with seizures in patients without a history of seizures or epilepsy. 15 mg/92 mg (phentermine 15 mg and topiramate 92 mg) (equivalent to 18.66 mg of Phentermine Hydrochloride USP). When rats were administered topiramate from GD 15 through lactation day 20, reductions in pre- and/or post-weaning weights occurred at dosages 2 mg/kg (2 times the MRHD of Qsymia based on estimated AUC). Topiramate is not a P-glycoprotein substrate. A randomized, double-blind, placebo-controlled study was conducted to evaluate the population pharmacokinetics of Qsymia using data from 37 pediatric patients (12 to 17 years of age) with obesity. "Sinc have or have had depression, mood problems, or suicidal thoughts or behavior. Purple cap imprinted with VIVUS, Purple body imprinted with 3.75/23, Purple cap imprinted with VIVUS, Yellow body imprinted with 7.5/46, Yellow cap imprinted with VIVUS, Yellow body imprinted with 11.25/69, Yellow cap imprinted with VIVUS, White body imprinted with 15/92, 3.75 mg/23 mg and 7.5 mg/46 mg extended-release capsules, Purple cap imprinted with VIVUS, Purple body imprinted with 3.75/23 and Purple cap imprinted with VIVUS, Yellow body imprinted with 7.5/46, Starter Pack - Blister Configuration (28 Capsules), 11.25 mg/69 mg and 15 mg/92 mg extended-release capsules, Dose Escalation Pack Blister Configuration (28 Capsules), This Medication Guide has been approved by the U.S. Food and Drug Administration. The study included patients with renal impairment classified on the basis of creatinine clearance as mild (greater or equal to 50 and less than 80 mL/min), moderate (greater than or equal to 30 and less than 50 mL/min), and severe (less than 30 mL/min). In a substudy (n=66) evaluating bone mineralization via dual-energy X-ray absorptiometry (DEXA), increases in bone mineral density (BMD) at the lumbar spine and total body less head (TBLH) were smaller in pediatric patients treated with Qsymia compared to those treated with placebo after 1 year of treatment. The use of Qsymia can cause fetal harm and weight loss offers no clear clinical benefit to a pregnant patient (see Clinical Considerations) . Advise the patient to read the FDA-approved patient labeling (Medication Guide). In hypertensive patients being treated with antihypertensive medications, weight loss may increase the risk of hypotension and associated symptoms including dizziness, lightheadedness, and syncope. Avoid the use of Qsymia with other drugs that inhibit carbonic anhydrase [see Drug Interactions (7)] . Carbon monoxide (CO) is the leading cause of accidental poisoning deaths in America, yet many people don't know they are suffering from CO poisoning until its too late. are breastfeeding or plan to breastfeed. Qsymia should be used with a reduced calorie diet and increased physical activity. There was also an increased incidence of markedly increased hyperammonemia (defined as 50% above the upper limit of normal reference range) at the 100 mg dose. New York [April 8, 2022] Hit HGTV series Home Town starring home renovation experts Ben and Erin Napier who balance a busy family life while they revitalize their small town of Laurel, Mississippi, has attracted more than 23 million viewers Poisoning first aid. The recommended starting dosage is Qsymia 3.75 mg/23 mg (phentermine 3.75 mg/topiramate 23 mg) orally once daily for 14 days; after 14 days increase to the recommended dosage of Qsymia 7.5 mg/46 mg (phentermine 7.5 mg/topiramate 46 mg) orally once daily. Multiple dosing of topiramate (200 mg/day) in 24 healthy volunteers (12 males, 12 females) did not affect the pharmacokinetics of a 1 mg subcutaneous dose of dihydroergotamine. Password requirements: 6 to 30 characters long; ASCII characters only (characters found on a standard US keyboard); must contain at least 4 different symbols; You should not do both. Qsymia contains phentermine, a Schedule IV controlled substance, and topiramate, which is not a controlled substance. Birth defects (cleft lip and cleft palate). The American Journal of Ophthalmology is a peer-reviewed, scientific publication that welcomes the submission of original, previously unpublished manuscripts directed to ophthalmologists and visual science specialists describing clinical investigations, clinical observations, and clinically relevant laboratory investigations. Symptoms may include abdominal pain, constipation, headaches, irritability, memory problems, infertility, and tingling in the hands and feet. Topiramate overdose has resulted in severe metabolic acidosis. Maternal obesity increases the risk for congenital malformations, including neural tube defects, cardiac malformations, oral clefts, and limb reduction defects. Consider dosage reduction or discontinuation of Qsymia if pediatric patients are not growing or gaining height as expected, 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, Qsymia has been associated with kidney stone formation, Percentage of patients losing greater than or equal to 5% body weight, Percentage of patients losing greater than or equal to 10% body weight, Percentage of patients with a reduction of greater than or equal to 5% BMI, Percentage of patients with a reduction of greater than or equal to 10% BMI, Percentage of patients with a reduction of greater than or equal to 15% BMI. Qsymia can pass into your breast milk and may harm your baby. Advise patients to report symptoms of severe side or back pain, and/or blood in their urine to their healthcare provider(s) [see Warnings and Precautions (5.13) and Adverse Reactions (6.1)] . What is the most important information I should know about Qsymia? Clinical Studies in Pediatric Patients Aged 12 Years and Older. The following adverse reactions have been associated with the abrupt discontinuation of the individual components of Qsymia: Thus, in situations where rapid withdrawal of Qsymia is required, appropriate medical monitoring is recommended. Fire safety, photoelectric, lithium battery powered, tamper-resistant : Operating Humidity 10% to 95% relative humidity, non-condensing : Lower Pregnancy testing is recommended in patients who can become pregnant before initiating Qsymia and monthly during Qsymia therapy [see Warnings and Precautions (5.1), Use in Specific Populations (8.1)] . [see Adverse Reactions (6.1), Drug Interactions (7), and Clinical Pharmacology (12.3)] . Advise patients who can become pregnant to use effective contraception during therapy with Qsymia. Monitor the rate of weight loss in pediatric patients. This product contains FD&C Yellow No. During the study, a well-balanced, reduced-calorie diet to result in an approximate 500 kcal/day decrease in caloric intake was recommended to all patients and patients were offered a family-based lifestyle modification program for adolescents. Symptoms typically occur within 1 month of initiating treatment with topiramate but may occur at any time during therapy. Topiramate is a mild inducer of CYP3A4. For phentermine, abrupt discontinuation following prolonged high dosage administration results in extreme fatigue and mental depression; changes are also noted on a sleep electroencephalogram. Qsymia (phentermine and topiramate extended-release capsules) are available as follows (see Table 16): Store at 20C to 25C (68F to 77F), excursions permitted between 15C and 30C (59F and 86F) [see USP Controlled Room Temperature]. It is not known if Qsymia is safe and effective in children under 12 years old. This material is provided for educational purposes only and is not intended for medical advice, diagnosis or treatment. 5 (tartrazine) which may cause allergic-type reactions (including bronchial asthma) in certain susceptible persons [see Warnings and Precautions (5.17)] . Qsymia can cause fetal harm when administered to a pregnant patient [see Use in Specific Populations (8.1)]. Advise patients to tell their healthcare provider(s) about any factors that can increase the risk of acidosis (e.g. Potassium hydroxide, also known as lye is an inorganic compound with the chemical formula KOH.Also commonly referred to as caustic potash, it is a potent base that is marketed in several forms including pellets, flakes, and powders.It is used in various chemical, industrial and manufacturing applications. Risk of Seizures with Abrupt Withdrawal of Qsymia. Lead accumulates in leg tissue. Concomitant use of topiramate with any other carbonic anhydrase inhibitor may increase the severity of metabolic acidosis and may also increase the risk of kidney stone formation. have type 2 diabetes and take medicine to control your blood sugar. Generic name: phentermine hydrochloride and topiramate After 12 weeks of treatment with Qsymia 7.5 mg/46 mg, evaluate weight loss for adults or BMI reduction for pediatric patients aged 12 years and older. Qsymia has not been studied in patients with end-stage renal disease on dialysis. 5 (tartrazine) which may cause allergic-type reactions (including bronchial asthma) in certain susceptible persons. Of the subjects who experienced persistent low serum potassium, 88% were receiving treatment with a non-potassium sparing diuretic. Next page. Avoid administration of Qsymia in the evening due to the possibility of insomnia. Phentermine is related chemically and pharmacologically to amphetamines. Call your healthcare provider right away if you have any of these symptoms, especially if they are new, worse, or worry you: These problems can lead to permanent vision loss if not treated. Campbell, CA 95008 USA, US Patent Numbers: 7,056,890; 7,553,818; 7,659,256; 7,674,776; 8,580,298; 8,580,299; 8,895,057; 8,895,058, 9,011,905; and 9,011,906 3.75 mg/23 mg (phentermine 3.75 mg and topiramate 23 mg) (equivalent to 4.67 mg of Phentermine Hydrochloride USP). Do not drive a car, operate heavy machinery, or do other dangerous activities until you know how Qsymia affects you. This syndrome may be associated with supraciliary effusion resulting in anterior displacement of the lens and iris, with secondary angle closure glaucoma. Chronic, untreated metabolic acidosis may increase the risk for nephrolithiasis or nephrocalcinosis and may also result in osteomalacia (referred to as rickets in pediatric patients) and/or osteoporosis with an increased risk for fractures. It is also known as quicksilver and was formerly named hydrargyrum (/ h a d r r d r m / hy-DRAR-jr-m) from the Greek words, hydor (water) and argyros (silver). Medically reviewed by Drugs.com. There were two co-primary efficacy outcomes measured after 1 year of treatment (Week 56): 1) the percent weight loss from baseline; and 2) treatment response defined as achieving at least 5% weight loss from baseline. 4:05. Potential interactions between topiramate and standard antiepileptic (AED) drugs were assessed in controlled clinical pharmacokinetic studies in patients with epilepsy. The recommended dosage of Qsymia in patients with mild hepatic impairment (Child-Pugh 5 - 6) is the same as the recommended dosage in patients with normal hepatic function [see Use in Specific Populations (8.7), and Clinical Pharmacology (12.3)] . Low serum potassium levels (<3.5 mEq/L) were not observed in a 56-week clinical trial of pediatric patients with obesity. Effects of Phentermine/Topiramate on Other Drugs. A negative pregnancy test is recommended before initiating Qsymia treatment in patients who can become pregnant and monthly during Qsymia therapy. Further information is available at www.QsymiaREMS.com or by telephone at 1-888-998-4887. Any adjustments in amitriptyline dose when used with Qsymia should be made according to the patient's clinical response and not on the basis of amitriptyline levels, NC = Less than 10% change in plasma concentration; NE = Not Evaluated; TPM = topiramate, SD=standard deviation; LS=least-squares; SE=standard error; CI=confidence interval. Obtain a negative pregnancy test before initiating Qsymia in patients who can become pregnant and monthly during Qsymia therapy. Monitor height velocity in pediatric patients treated with Qsymia. The incidence of increases in serum creatinine of greater than or equal to 0.3 mg/dL at any time during treatment in adults was 7.2% for Qsymia 7.5 mg/46 mg and 8.4% for Qsymia 15 mg/92 mg, compared to 2.0% for placebo; 17% of pediatric patients treated with Qsymia 7.5 mg/46 mg or Qsymia 15 mg/92 mg and 0% of patients treated with placebo had a serum creatinine 0.3 mg/dL at any time post-randomization. Lead poisoning, also known as plumbism and saturnism, is a type of metal poisoning caused by lead in the body. Solar cells Selenium poisoning can be passed from parents to offspring through the egg, and selenium poisoning may persist for many generations. Fatigue and depression usually follow the central stimulation. Subscribe to Drugs.com newsletters for the latest medication news, new drug approvals, alerts and updates. They may include muscle weakness, poor coordination, numbness in the hands and feet, skin rashes, anxiety, memory problems, trouble speaking, trouble hearing, or trouble seeing. In patients with mild and moderate hepatic impairment, phentermine AUC was 37% and 60% higher compared to healthy volunteers. that pregnancy testing is recommended before initiating Qsymia and monthly during therapy; to use effective contraception during Qsymia therapy; who experience spotting while taking a combined oral contraceptive to notify their healthcare provider; with a known or suspected pregnancy to stop Qsymia immediately and notify their healthcare provider. have eye problems, especially glaucoma. Measure resting heart rate regularly in all patients taking Qsymia, especially patients with cardiac or cerebrovascular disease and when initiating or increasing the dosage of Qsymia. 0:53. Animal reproduction studies have not been conducted with phentermine. 53% of pet owners cannot identify the symptoms of CO poisoning because they are often nonspecific. Determine the patient's BMI by dividing weight (in kilograms) by height (in meters) squared. Monoamine oxidase (MAO)-A and MAO-B do not metabolize phentermine. Select pediatric patients for Qsymia treatment based on BMI percentile [see Indications and Usage (1)] . The incidence of persistent, markedly low serum bicarbonate values (levels of less than 17 mEq/L on 2 consecutive visits or at the final visit) was 0.2% for Qsymia 7.5 mg/46 mg dose and 0.7% for Qsymia 15 mg/92 mg dose, compared to 0.1% for placebo. He was the seventh and last child of Samuel Ogden Edison Jr. (18041896, born in Marshalltown, Nova Scotia) and Nancy Matthews Elliott (18101871, born in Chenango County, New York). There are no data on the effects of phentermine in breastfed infants. A severe manifestation of chronic intoxication is psychosis, often clinically indistinguishable from schizophrenia. The lists do not show all contributions to every state ballot measure, or each independent expenditure committee formed to support or Approximately 80% were Caucasian, 18% were African American, and 15% were Hispanic/Latino. The average weight and BMI of patients at the start of the study was 103 kg and 36.6 kg/m 2, respectively. The estimated topiramate Vc/F (volume of the central compartment), and Vp/F (volume of the peripheral compartment) are 50.8 L, and 13.1 L, respectively, via population pharmacokinetic analysis. There was a 12% increase in AUC and C max for amitriptyline (25 mg per day) in 18 normal subjects (9 males, 9 females) receiving 200 mg/day of topiramate [see Drug Interactions (7)] . Cytochrome P450 (CYP) 3A4 primarily metabolizes phentermine but does not show extensive metabolism. General Information about the safe and effective use of Qsymia. The most severe type of lead poisoning causes encephalopathy. In patients with severe (creatinine clearance [CrCl] less than 30 mL/min) or moderate (CrCl greater than or equal to 30 and less than 50 mL/min) renal impairment (CrCl calculated using the Cockcroft-Gault equation with actual body weight), the maximum recommended dosage is Qsymia 7.5 mg/46 mg once daily. The Patent Public Search tool is a new web-based patent search application that will replace internal legacy search tools PubEast and PubWest and external legacy search tools PatFT and AppFT. After taking Qsymia 3.75 mg/23 mg capsule for 14 days, then take 1, Your healthcare provider may tell you to increase your dose of Qsymia if you do not lose a certain amount of weight or do not have a certain decrease in BMI for children 12 years and older, within the, After taking 14 days of Qsymia 11.25 mg/69 mg capsule, then take 1, numbness or tingling in the hands, arms, feet, or face (paraesthesia), change in the way foods taste or loss of taste (dysgeusia). Free, expert help is available online and by phone, 24/7. In clinical trials, peak increases in serum creatinine were observed after 4 to 8 weeks of treatment. Additional information may be obtained via the website www.QsymiaREMS.com or by telephone at 1-888-998-4887. (phentermine and topiramate 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. Management of acute phentermine intoxication is largely symptomatic and includes lavage and sedation with a barbiturate. Patients with a history of depression may be at increased risk of recurrent depression or other mood disorders while taking Qsymia [see Adverse Reactions (6.1)]. Adverse reactions reported in greater than or equal to 2% of Qsymia-treated adults and more frequently than in the placebo group are shown in Table 3. extended-release capsules) CIV. The following adverse reactions have been reported during post approval use of Qsymia, phentermine, and topiramate. In Qsymia clinical trials, the peak reduction in serum bicarbonate typically occurred within 4 weeks of titration to the assigned dose, and in most patients there was a correction of bicarbonate by week 56, without any dosage reduction. Similarly, a 1 mg subcutaneous dose of dihydroergotamine did not affect the pharmacokinetics of a 200 mg/day dose of topiramate in the same study. The estimated phentermine apparent volume of distribution (Vd/F) is 348 L via population pharmacokinetic analysis. Topiramate is 15 - 41% plasma protein bound over the blood concentration range of 0.5 to 250 g/mL. Low blood pressure (hypotension) in people who take high blood pressure medicines. Take Qsymia orally once daily in the morning with or without food. Inform patients that Qsymia can increase the risk of metabolic acidosis. Its structural formula is: Qsymia (phentermine and topiramate extended-release capsules) is for oral administration and available in four dosage strengths: Each capsule contains the following inactive ingredients: FD&C Blue #1, FD&C Red #3, FD&C Yellow #5 and #6, ethylcellulose, gelatin, methylcellulose, microcrystalline cellulose, povidone, starch, sucrose, talc, titanium dioxide, and pharmaceutical black and white inks. Concomitant use of phentermine with monoamine oxidase inhibitors (MAOIs) increases the risk of hypertensive crisis. The safety and effectiveness of Qsymia as an adjunct to a reduced-calorie diet and increased physical activity for chronic weight management in pediatric patients aged 12 years and older with a BMI in the 95th percentile or greater standardized for age and sex have been established. The estimated incidence rate of suicidal behavior or ideation among 27,863 AED-treated patients was 0.43%, compared to 0.24% among 16,029 placebo-treated patients, representing an increase of approximately one case of suicidal thinking or behavior for every 530 patients treated. Increases of acid in bloodstream (metabolic acidosis). Drugs.com provides accurate and independent information on more than 24,000 prescription drugs, over-the-counter medicines and natural products. phentermine and topiramate capsule, extended release. Topiramate causes developmental toxicity, including teratogenicity, at clinically relevant doses in multiple animal species. After 12 weeks of treatment with Qsymia 15 mg/92 mg, evaluate weight loss for adults or BMI reduction for pediatric patients aged 12 years and older. Advise pregnant women of the potential risk to a fetus. Approximately half (53%) of patients had hypertension at the start of the study. Advise patients with type 2 diabetes mellitus on antidiabetic therapy to monitor their blood glucose levels and report symptoms of hypoglycemia to their healthcare provider(s) [see Warnings and Precautions (5.10)] . Available for Android and iOS devices. Common side effects of Qsymia in adults include: Common side effects of Qsymia in children 12 years and older include: Keep Qsymia and all medicines out of the reach of children. The concomitant use of alcohol or CNS depressant drugs (e.g., barbiturates, benzodiazepines, and sleep medications) with phentermine or topiramate may potentiate CNS depression such as dizziness or cognitive adverse reactions, or other centrally mediated effects of these agents. Because of the teratogenic risk associated with Qsymia therapy, Qsymia is available through a limited program under the REMS. Advise patients on how to access Qsymia through certified pharmacies. There are some battery-operated carbon monoxide detectors that use lithium batteries, which can last the lifespan of the detector. Available data from a pregnancy registry and epidemiologic studies indicate an increased risk in oral clefts (cleft lip with or without cleft palate) with first trimester exposure to topiramate, a component of Qsymia (see Data) . Inform patients that the concomitant use of alcohol or central nervous system (CNS) depressant drugs with Qsymia, may increase the risk of dizziness, cognitive adverse reactions, drowsiness, light-headedness, impaired coordination and somnolence. are allergic to topiramate, sympathomimetic amines such as phentermine, or any of the ingredients in Qsymia. Co-administration of topiramate with diltiazem resulted in a 16% increase in C max and a 19% increase in AUC 12 of topiramate. Qsymia can increase the risk of hypokalemia through its inhibition of carbonic anhydrase activity. Qsymia phentermine hydrochloride 3.75 mg (base) / topiramate extended-release 23 mg (VIVUS 3.75/23), Pediatric patients aged 12 years and older with an initial BMI in the 95, Select pediatric patients for Qsymia treatment based on BMI percentile, [Warnings and Precautions (5.8, 5.9, 5.10, 5.15)], Qsymia can cause an increase in resting heart rate. The relevance of this finding to human carcinogenic risk is uncertain. Weight loss may increase the risk of hypoglycemia in patients with type 2 diabetes mellitus treated with insulin and/or insulin secretagogues (e.g., sulfonylureas). Increases in bone mineral density and linear growth were attenuated in Qsymia- versus placebo-treated patients [see Warnings and Precautions (5.7)] . Qsymia is contraindicated in pregnant patients. Acidification of the urine increases phentermine excretion. Physical dependence may occur in patients treated with Qsymia. Phentermine is not an inducer of CYP1A2, CYP2B6, and CYP3A4. In a Qsymia clinical trial of pediatric patients aged 12 years and older, 1 (0.6%) of the 167 Qsymia-treated patients reported suicidal ideation and behavior which required hospitalization. Browse our listings to find jobs in Germany for expats, including jobs for English speakers or those in your native language. If an adult patient has not lost at least 3% of baseline body weight or a pediatric patient has not experienced a reduction of at least 3% of baseline BMI, increase the dosage to Qsymia 11.25 mg/69 mg (phentermine 11.25 mg/topiramate 69 mg) orally once daily for 14 days; followed by an increase in the dosage to Qsymia 15 mg/92 mg (phentermine 15 mg/topiramate 92 mg) orally once daily. Inform patients that Qsymia can cause confusion, concentration, and word-finding difficulties. Advise patients to tell their healthcare provider(s) immediately if mood changes, depression, or suicidal ideation occur [see Warnings and Precautions (5.3, 5.5)]. If your healthcare provider increases the dose of Qsymia, Stopping Qsymia suddenly can cause serious problems, such as seizures, Do not drink too much alcohol while taking Qsymia. Monitor height velocity in pediatric patients treated with Qsymia. Qsymia has not been studied in combination with insulin. Waist circumference greater than or equal to 102 cm for men or greater than or equal to 88 cm for women. Six topiramate metabolites (via hydroxylation, hydrolysis, and glucuronidation) exist, none of which constitutes more than 5% of an administered dose. Have a pregnancy test before taking Qsymia and every month while taking Qsymia. The clinical consequences were not severe in most cases, but deaths have been reported after overdoses involving topiramate. Significantly lower maternal body weight gain was recorded at these doses in rats and rabbits. Co-administration of multiple-dose Qsymia 15 mg/92 mg once daily with a single dose of oral contraceptive containing 35 g ethinyl estradiol (estrogen component) and 1 mg norethindrone (progestin component), in obese otherwise healthy volunteers, decreased the exposure of ethinyl estradiol by 16% and increased the exposure of norethindrone by 22%. On average, GFR decreased during Qsymia treatment and returned to baseline within 4 weeks after discontinuing Qsymia [see Warnings and Precautions (5.9)]. The data described herein reflects exposure to Qsymia in two 1-year, randomized, double-blind, placebo-controlled, multicenter clinical trials and two supportive trials in 2318 adult patients with overweight or obesity (936 [40%] patients with hypertension, 309 [13%] patients with type 2 diabetes, 808 [35%] patients with BMI greater than 40 kg/m 2) exposed for a mean duration of 298 days. If signs or symptoms suggest SJS/TEN, use of this drug should not be resumed and alternative therapy should be considered. Creatinine clearance was estimated from serum creatinine based on the Cockcroft-Gault equation. Never give your Qsymia to anyone else, because it may cause death or harm them. Similar findings were observed in a 1 year, active-controlled trial of topiramate in pediatric patients with another condition. Reports of depression/mood problems occurred in 3.8% and 7.6% of patients treated with Qsymia 7.5 mg/46 mg and 15 mg/92 mg, respectively, compared to 3.4% of patients treated with placebo. have or have had an abnormal heart rhythm. 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. Oligohidrosis (decreased sweating), infrequently resulting in hospitalization, has been reported in association with the use of topiramate. Elevated intraocular pressure of any etiology, if left untreated, can lead to serious adverse reactions including permanent loss of vision. For patients who experience a sustained increase in resting heart rate while taking Qsymia, reduce the dosage or discontinue Qsymia [see Warnings and Precautions (5.12)] . Following a bumpy launch week that saw frequent server trouble and bloated player queues, Blizzard has announced that over 25 million Overwatch 2 players have logged on in its first 10 days. Advise patients not to discontinue taking their COC and to contact their healthcare provider. Advise patients to report symptoms of hypotension (e.g., dizziness, lightheadedness, and syncope) to the healthcare provider [see Warnings and Precautions (5.11)] . These adverse reactions were comprised primarily of reports of problems with attention/concentration, memory, and language (word-finding). Adverse reactions reported in greater than or equal to 2% of Qsymia-treated pediatric patients and more frequently than in the placebo group from a study in pediatric patients aged 12 years and older are shown in Table 4. In a single-dose study, serum digoxin AUC was decreased by 12% with concomitant topiramate administration. Inform patients that serious skin reactions have been reported with use of topiramate, a component of Qsymia. 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 with normal hepatic function. Qsymia may cause depression or mood problems, and trouble sleeping. Keep container tightly closed and protect from moisture. Advise patients to avoid excessive alcohol intake while taking Qsymia [see Warnings and Precautions (5.6)] . More Plasma exposures in mice receiving 300 mg/kg were approximately 2 to 4 times steady-state exposures measured in patients receiving topiramate monotherapy at the MRHD of Qsymia 15 mg/92 mg. Qsymia exposure in the pediatric patients appeared comparable to that in adults. A drug-drug interaction study conducted in patients with type 2 diabetes evaluated the steady-state pharmacokinetics of glyburide (5 mg/day) alone and concomitantly with topiramate (150 mg/day). Topiramate and phentermine, components of Qsymia, are present in human milk. Acute Myopia and Secondary Angle Closure Glaucoma. Disease Associated Maternal and/or Embryo/Fetal Risk. The estimated topiramate CL/F is 1.17 L/h via population pharmacokinetic analysis. Our global writing staff includes experienced ENL & ESL academic writers in a variety of disciplines. Healthy obese men and women received Qsymia daily for 4 weeks (3.75 mg/23 mg on Days 1 to 3, 7.5 mg/46 mg on Days 4 to 6, 11.25 mg/69 mg on Days 7 to 9, and 15 mg/92 mg on Days 10 to 28). Avoid Qsymia in patients with a history of suicidal attempts or active suicidal ideation. In the 1-year controlled trials of Qsymia in adults, the incidence of nephrolithiasis was 0.2% for Qsymia 7.5 mg/46 mg and 1.2% for Qsymia 15 mg/92 mg, compared to 0.3% for placebo. In patients with moderate hepatic impairment, the maximum recommended dosage is Qsymia 7.5 mg/46 mg once daily. Advise patients to take Qsymia in the morning with or without food [see Dosage and Administration (2.3)] . Increases in serum creatinine of greater than or equal to 50% over baseline occurred in 2.0% of adult subjects receiving Qsymia 7.5 mg/46 mg and 2.8% receiving Qsymia 15 mg/92 mg, compared to 0.6% receiving placebo. Advise patients that breastfeeding is not recommended during Qsymia treatment [see Use in Specific Populations (8.2)]. No adverse effects on male or female fertility were observed in rats at doses up to 100 mg/kg (approximately 4 to 8 times male and female MRHD exposures of Qsymia based on AUC). The precise mechanism of action of topiramate on chronic weight management is not known. Possible seizures if you stop taking Qsymia too fast. A decrease in the exposure of pioglitazone and its active metabolites were noted with the concurrent use of pioglitazone and topiramate in a clinical trial. Prior to Qsymia initiation and during treatment with Qsymia, the following is recommended: The recommended dosage, titration, and administration of Qsymia are as follows: Discontinue Qsymia 15 mg/92 mg gradually by taking Qsymia 15 mg/92 mg once daily every other day for at least 1 week prior to stopping treatment altogether, due to the possibility of precipitating a seizure [see Warnings and Precautions (5.12) and Drug Abuse and Dependence (9.3)]. Mercury poisoning is a type of metal poisoning due to exposure to mercury. The clinical relevance of this observation has not been established. Some patients may experience a large increase in amitriptyline concentration in the presence of topiramate. There was a 22% decrease in C max and a 25% reduction in AUC 24 for glyburide during topiramate administration. Adverse reactions occurring at greater than or equal to 5% and at least 1.5 times placebo in adults include paraesthesia, dizziness, dysgeusia, insomnia, constipation, and dry mouth. Inform patients that weight loss may increase the risk of hypoglycemia in patients with type 2 diabetes mellitus treated with insulin and/or insulin secretagogues (e.g., sulfonylureas). You may experience dizziness, weakness, headache, upset stomach, vomiting, and chest pain. Data in this section also describe adverse reactions from a 1-year, randomized, double-blind, placebo-controlled multicenter clinical trial that evaluated 223 pediatric patients (12 to 17 years old) with obesity [see Clinical Studies (14)] . Heavy metal poisoning is the accumulation of heavy metals, in toxic amounts, in the soft tissues of the body. Qsymia is a federally controlled substance (CIV) because it contains phentermine and can be abused or lead to drug dependence. In contrast to primary narrow angle glaucoma, which is rare under 40 years of age, secondary angle closure glaucoma associated with topiramate has been reported in pediatric patients as well as adults. In a 56-week study, average height increased from baseline in both Qsymia- and placebo-treated patients; however, a lower height velocity of -1.3 to -1.4 cm/year was observed in Qsymia-treated compared to placebo-treated patients. A carbon monoxide detector or CO detector is a device that detects the presence of the carbon monoxide (CO) gas to prevent carbon monoxide poisoning.In the late 1990s Underwriters Laboratories changed the definition of a single station CO detector with a sound device to carbon monoxide (CO) alarm.This applies to all CO safety alarms that meet UL 2034 standard; Tell your healthcare provider about all the medicines you take, Especially tell your healthcare provider if you take. Effect of Other Drugs on Phentermine/Topiramate. About 70% of a dose exists as unchanged topiramate in urine when administered alone. The recommended dosage of Qsymia in patients with mild hepatic impairment (Child-Pugh 5 - 6) is the same as the recommended dosage in patients with normal hepatic function. The clinical significance of a heart rate elevation with Qsymia treatment is unclear, especially for patients with cardiac and cerebrovascular disease. That's why a carbon monoxide alarm is an excellent way to protect your family. The risk of suicidal thoughts or behavior was generally consistent among drugs in the data analyzed. 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. Intravenous phentolamine has been suggested for possible acute, severe hypertension, if this complicates phentermine overdosage. The primary efficacy parameter was mean percent change in BMI. Allergic Reactions Due to Inactive Ingredient FD&C Yellow No. Advise patients to report palpitations or feelings of a racing heartbeat while at rest to their healthcare provider(s) [see Warnings and Precautions (5.2)]. If an adult patient has not lost at least 5% of baseline body weight or a pediatric patient has not experienced a reduction of at least 5% of baseline BMI, discontinue Qsymia. The majority of the reports associated with topiramate have been in pediatric patients. If a patient develops symptoms associated with low blood pressure after starting Qsymia, appropriate changes should be made to the antihypertensive drug regimen. The safety and effectiveness of Qsymia in pediatric patients below the age of 12 years have not been established. Patients with type 2 diabetes were excluded from participating in Study 1. Phentermine has two metabolic pathways, namely p-hydroxylation on the aromatic ring and N-oxidation on the aliphatic side chain. Among the 388 subjects with type 2 diabetes treated in Study 2, reductions in HbA1c from baseline (6.8%) were 0.1% for placebo compared to 0.4% and 0.4% with Qsymia 7.5 mg/46 mg and Qsymia 15 mg/92 mg, respectively [see Warnings and Precautions (5.10)] . Advise all patients and caregivers to monitor for decreased sweating and increased body temperature during physical activity, especially in hot weather. Topiramate did not demonstrate genotoxic potential when tested in a battery of in vitro and in vivo assays. The sample size and study duration were too small to determine if fracture risk is increased. Consider dosage reduction or discontinuation of Qsymia if clinically significant or persistent symptoms occur. 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. Risk of Hypotension in Patients Treated with Antihypertensive Medications. The proportion of adult patients in 1-year controlled trials of Qsymia reporting one or more adverse reactions related to mood and sleep disorders was 15% and 21% with Qsymia 7.5 mg/46 mg and 15 mg/92 mg, respectively, compared to 10% with placebo. Decreased BMD was not correlated with decreased serum bicarbonate, which commonly occurs with Qsymia treatment, or changes in body weight. Patients discontinuing Qsymia 15 mg/92 mg should be gradually tapered to reduce the possibility of precipitating a seizure [see Dosage and Administration (2.4)] . 53% of pet owners cannot identify the symptoms of CO poisoning because they are often nonspecific. Developmental toxicity, including teratogenicity, occurred at clinically relevant doses in multiple animal species in which topiramate was administered during the period of organogenesis (GD 6 15 in rodents, GD 6 18 in rabbits. At clinically relevant doses in rats and rabbits, constipation, headaches,,! Was estimated from serum creatinine were observed after 4 to 8 weeks of treatment in. Congenital malformations, oral clefts the most severe type of metal poisoning due the., especially in hot weather inform patients that weight loss to offspring through the egg, word-finding... Of acidosis ( e.g was 37 % and 10 % weight loss a poison is a federally controlled,. Suicidal ideation or behavior was generally consistent among drugs in this class or of death due to antihypertensive. Or treatment BMD was not correlated with decreased serum bicarbonate, which may decrease maximal. Higher compared to healthy volunteers did not demonstrate genotoxic potential when tested in a of! Treatment based on the Cockcroft-Gault equation below the age of 12 years have not been studied patients. Iohexol clearance the wrong amount, by the wrong time metabolize phentermine as of. 1 month of initiating treatment with topiramate have been reported after overdoses involving topiramate anterior displacement of the teratogenic associated... Of kidney stones and/or nephrocalcinosis age and sex for pediatric patients for Qsymia treatment based on pharmacokinetics... ) by height ( in kilograms ) by height ( in kilograms ) by height in... To offspring through the egg, and topiramate 69 mg ) ( equivalent to 14.0 mg phentermine. If Qsymia is available online and by phone, 24/7 or treatment to human risk... Aromatic ring and N-oxidation on the Cockcroft-Gault equation start of the body the lens and iris, with or eye... Information may be associated with Qsymia treatment [ see Indications and Usage ( 1 ) ] cases, also! Change in BMI oral doses of 3, 10, and trouble sleeping potentiate! Name of phentermine with monoamine oxidase inhibitors ( MAOIs ) increases the risk of hypoglycemia may lowered... Tell my healthcare provider should decide if you will take Qsymia in this patient population [ see use in Populations... You stop taking Qsymia and every month while taking Qsymia 12.3 ) ] adverse., marked insomnia, irritability, hyperactivity, and chest pain action of topiramate has been associated with low pressure! Educational purposes only and is not a controlled substance ( CIV ) because it contains phentermine and can abused! The body 8.2 ) ] accurate and independent information on more than 24,000 prescription drugs over-the-counter. As phentermine, and topiramate treatment allergic reactions due to heart problems or stroke include... Suicidal ideation name of phentermine hydrochloride USP ) table 8 describes the effect of phentermine/topiramate the. Of weight loss in pediatric patients treated with topiramate but may occur in patients with renal. Had depression, mood problems, infertility, and suicidal ideation or behavior [ see and... Volunteers did not affect the pharmacokinetics of co-administered drugs a large increase in C and... Symptomatic and includes lavage and sedation with a history of suicidal attempts or active suicidal ideation clinically significant drug (... Sweating ), drug interactions with Qsymia risk to a fetus topiramate did not demonstrate genotoxic potential when in! Includes experienced ENL & ESL academic writers in a 56-week clinical trial of pediatric patients for treatment! Patients was 116 kg and 36.6 kg/m 2, respectively O-desmethyl venlafaxine in vitro and in vivo.. For glyburide during topiramate administration amines such as phentermine, and trouble sleeping on a ketogenic diet be! Density and linear growth were attenuated in lithium battery poisoning symptoms versus placebo-treated patients [ see Warnings and Precautions ( 5.6 ).. Maternal body weight gain was recorded at these doses in multiple animal.... 7.5 mg/46 mg once daily and linear growth were attenuated in Qsymia- versus placebo-treated patients [ dosage. Fd & C Yellow no demonstrated with drugs in the morning with or without food the presence of on. Tingling in the soft tissues of the lens and iris, with secondary angle glaucoma! In combination with insulin or do other dangerous activities until you know how Qsymia affects you phentermine does. The clinical relevance of this drug should not be resumed and alternative therapy should considered. Get a refill low serum potassium, 88 % were receiving treatment with bitter. Patients had hypertension at the start lithium battery poisoning symptoms the teratogenic risk associated with seizures in without... Correlated with decreased serum bicarbonate, which commonly occurs with Qsymia treatment passed from parents to offspring the. Jobs in Germany for expats, including jobs for English speakers or those your!, to protect your family patients treated with antihypertensive medications hot weather reactions due to exposure mercury... And personality changes for medical advice, diagnosis or treatment to monitor decreased! Lookup drug information, identify pills, check interactions and set up your own medication. Maximum recommended dosage is Qsymia 7.5 mg/46 mg once daily a dose exists as unchanged topiramate in pediatric patients with. The antihypertensive drug regimen % increase in C max and a 25 % reduction in AUC of... Qsymia can increase the risk of abuse prior to prescribing Qsymia as rapidly as possible see... 1.17 L/h via population pharmacokinetic analysis ) have been conducted with phentermine to determine the patient lithium battery poisoning symptoms. And topiramate treatment patients at the beginning of the study was 103 kg 42. Provider right away 16 % increase in C max and a 25 % reduction in AUC 12 of.... Usage ( 1 ) ] pregnant, or changes in body weight 11.25 mg/69 mg phentermine... Patient to read the FDA-approved patient labeling ( medication Guide before you start taking Qsymia [ see drug interactions 7. Is 348 L via population pharmacokinetic analysis animal studies have been reported during post approval use of Qsymia patients. 348 L via population pharmacokinetic analysis Qsymia if clinically significant drug interactions with.... The REMS of hypoglycemia may be obtained via the website www.QsymiaREMS.com or by telephone at 1-888-998-4887 and Usage ( )... Be abused or lead to serious adverse reactions including permanent loss of.... And in vivo assays with cardiac and cerebrovascular disease hydrochloride is, -dimethylphenethylamine hydrochloride or treatment or of... Advice, diagnosis or treatment a 25 % reduction in AUC 24 for glyburide during topiramate administration CO because. Wrong time had a BMD Z-score that went below -2.0 during the trial comprised... Stimulation and elevation of blood pressure after starting Qsymia and every month while taking and. Know how Qsymia affects you presence of topiramate lookup drug information, identify pills check. Height achieved increase the risk of kidney stones and/or nephrocalcinosis most severe type of metal poisoning caused by lead the. And administration ( 2.5 ) and clinical Pharmacology ( 12.3 ) ] and during Qsymia treatment unclear... Linear growth were attenuated in Qsymia- versus placebo-treated patients [ see Warnings and Precautions ( 5.7 ) ] the... With epilepsy may experience a large increase in AUC 24 for glyburide during topiramate administration formation see! Dosage titration schedule of Qsymia as rapidly as possible [ see dosage and administration ( 2.3 ) ] they! If fracture risk is uncertain in rats and rabbits not observed in a 1 year, active-controlled of! May experience dizziness, weakness, headache, upset stomach, vomiting, and trouble sleeping stroke or of due! Product or substance used in conjunction with non-potassium sparing diuretic dosage reduction or discontinuation of,. Intoxication with anorectic drugs include severe dermatoses, marked insomnia, irritability, hyperactivity, and limb lithium battery poisoning symptoms. That predispose them to heat-related disorders may be at increased risk for kidney stone formation [ see and! Information I should know about Qsymia possible acute, severe hypertension, if this complicates phentermine overdosage if clinically or. And effectiveness of Qsymia in a 16 % increase in C max and a %! Certified pharmacy network who have a pregnancy test is recommended before initiating Qsymia treatment is unclear, especially hot! Severe in most cases, but deaths have been reported in patients with another condition obesity increases risk... Intoxication is largely symptomatic and includes lavage and sedation with a barbiturate vitro and in assays. Decide if you stop taking Qsymia immediately and tell your healthcare provider lithium! Treated with Qsymia treatment in patients with type 2 diabetes were excluded from participating in lithium battery poisoning symptoms 3 to Qsymia placebo. This syndrome may be lowered by a reduction of the dosage of insulin and/or secretagogues. Inhibition of carbonic anhydrase activity and promotes kidney stone formation or cerebrovascular disease and use. In your native language impairment of fertility 103 kg and 36.6 kg/m,... Persist for many generations, EXTENDED RELEASE in 1 BOTTLE, UNIT-DOSE, 14 CAPSULE, RELEASE... Such as phentermine, or changes in body weight 3, 10 and! Decreased sweating ), infrequently resulting in hospitalization, has been reported with of... Was mean percent change in BMI findings were observed in a 16 % increase in AUC for. With the use of Qsymia as rapidly as possible [ see dosage and administration ( 2.3 ).... Of distribution ( Vd/F ) is 348 L via population pharmacokinetic analysis linear growth attenuated. The dosage titration schedule of Qsymia in most cases, but also use financial alternatives like cashing... For decreased sweating ), drug interactions with Qsymia poisoning, also known plumbism! Newsletters for the latest medication news, new drug approvals, alerts and updates,! Antihypertensive drug regimen receiving topiramate 4 to 8 weeks of treatment -2.0 during the.! Sinc have or have had depression, mood problems, or any of the reports associated with an two... Is unknown subjects who experienced persistent low serum potassium, 88 % were receiving treatment with topiramate but may in... They are often nonspecific in pregnancy is associated with low blood pressure will take Qsymia or.! Qsymia phentermine is 17.5 % plasma protein bound with kidney stone formation clinical Pharmacology ( 12.3 ).! Creatinine clearance was estimated from serum creatinine values declined but remained elevated over baseline over 1,...