Indications for QSYMIA:
As an adjunct to a reduced-calorie diet and increased physical activity for chronic weight management in adults with an initial BMI of ≥30kg/m2 or ≥27kg/m2 in the presence of at least one weight related co-morbidity (eg, hypertension, type 2 diabetes, or dyslipidemia).
Limitations of Use:
Effects on cardiovascular morbidity/mortality not established. Safety, effectiveness in combination with other weight loss products not established.
Take once daily in the AM. Initially 3.75mg/23mg for 14 days; then increase to 7.5mg/46mg and evaluate weight loss after 12 weeks on this dose. If patient has not lost ≥3% baseline body weight, discontinue or escalate dose. To escalate dose: increase to 11.25mg/69mg for 14 days, then increase to 15mg/92mg and evaluate weight loss after additional 12 weeks at this dose. If patient has not lost ≥5% baseline body weight, discontinue by taking a dose every other day for at least 1 week prior to stopping altogether. Qsymia 3.75mg/23mg and 11.25mg/69mg strengths are for titration purposes only. Renal (moderate or severe), hepatic (moderate) impairment: max 7.5mg/46mg once daily.
<18yrs: not recommended.
Pregnancy. Glaucoma. Hyperthyroidism. During or within 14 days of MAOIs.
Embryo-fetal toxicity: perform pregnancy testing before initiating and monthly during therapy; advise females of reproductive potential to use effective contraception. ESRD on dialysis, severe hepatic impairment: avoid. Recent or unstable cardiac or cerebrovascular disease: not recommended. Measure resting heart rate regularly. History of suicidal attempts or active suicidal ideation: avoid. Monitor for worsening of depression, suicidal thoughts, unusual behaviors. Depression. Sleep disorders. Measure electrolytes including serum bicarbonate, potassium, creatinine, blood glucose (in diabetics), BP (in patients on antihypertensives) prior to starting and during therapy. Ketogenic diet. Avoid abrupt withdrawal (seizure risk). Monitor for decreased sweating and increased body temperature during physical activity. Nursing mothers: not recommended.
Sympathomimetic amine + antiepileptic.
See Contraindications. Avoid alcohol. May potentiate CNS depression with concomitant other CNS depressants (eg, barbiturates, benzodiazepines, hypnotics). Avoid other carbonic anhydrase inhibitors (eg, zonisamide, acetazolamide, dichlorphenamide, methazolamide). Increased risk of hypokalemia with concomitant non-K+-sparing diuretics (eg, furosemide, HCTZ). May be antagonized by phenytoin, carbamazepine. May antagonize pioglitazone (monitor glucose control). Hyperammonemia w/wo encephalopathy with concomitant valproic acid. May affect oral contraceptives (spotting may occur).
Paraesthesia, dizziness, dysgeusia, insomnia, constipation, dry mouth; acute myopia and secondary angle closure glaucoma (discontinue if occurs), cognitive dysfunction, metabolic acidosis, increased serum creatinine, kidney stones, oligohidrosis, hyperthermia.
Only available through certified pharmacies enrolled in Qsymia REMS program. For more information call (888) 998-4887.
Generic Drug Availability:
Caps 3.75mg/23mg—14, 30; 7.5mg/46mg, 11.25mg/69mg, 15mg/92mg—30; Starter Pack (3.75mg/23mg + 7.5mg/46mg)—28; Dose Escalation Pack (11.25mg/69mg + 15mg/92mg)—28