See Supplemental Patient Information
- Therapy may cause fetal harm; it may also increase risk of oral clefts in the first trimester of pregnancy. Discontinue the treatment if pregnancy is suspected, or if a patient becomes pregnant while on therapy, they should be informed of the potential hazard to the fetus
- Therapy may increase resting heart rate. Evaluate resting heart rate in all patients, particularly those with cardiac or cerebrovascular disease or when initiating or increasing dose. Consider dose reduction or discontinuation if sustained increase in resting HR or if persistent creatinine elevations occur
- Increased risk of suicidal behavior/ideation, mood changes, depression, persistent eye pain or visual changes, or cognitive adverse reactions have been reported with therapy
- Acute myopia associated with secondary angle closure glaucoma has occurred; discontinue if decreased visual acuity and/or ocular pain anterior chamber shallowing, ocular hyperemia and increased ICP occurs
- Therapy may cause mood disorders including depression, anxiety, and insomnia. Consider dose reduction or discontinuation for clinically significant or persistent symptoms
- Therapy may cause cognitive dysfunction such as impairment of concentration/attention, difficulty with memory, speech or language problems, and word-finding difficulties. Consider dose reduction or withdrawal if cognitive dysfunction persists
- Hyperchloremic, non-anion gap, metabolic acidosis may occur in patients treated with this drug. Concomitant use of therapy with a carbonic anhydrase inhibitor may lead to increased severity of metabolic acidosis and increase the risk of kidney stone formation. Measure electrolytes including serum bicarbonate before initiating therapy
- Therapy may cause an increase in serum creatinine levels resulting in a decrease in renal function. Monitor serum creatinine prior to starting therapy. In cases of persistent elevations in creatinine, consider reducing dose or discontinuing the therapy
- Weight loss may increase risk of hypoglycemia in patients with type 2 diabetes mellitus on antidiabetic therapy and risk of hypotension in those treated with antihypertensives; appropriate changes should be made to antidiabetic or antihypertensive therapy if hypoglycemia or symptoms associated with low BP develop
- Increased risk of seizures associated with abrupt withdrawal of therapy has been reported. Reduce dose gradually and monitor for seizures in situations where immediate termination of therapy is required
- Avoid therapy in patients with end-stage renal disease on dialysis and in those with severe hepatic impairment
- Oligohidrosis may occur in patients receiving this drug. Monitor patients for decreased sweating and increased body temperature during physical activity
- Increased hypokalemia has been reported with therapy. Monitor hypokalemia
- Monitor blood chemistry profile including bicarbonate, creatinine, potassium, and glucose at baseline and periodically during treatment
Cautions: Use cautiously in
- CNS depressant use
- Hx of depression
- Hx of nephrolithiasis
- Suicidal ideation
- Diabetes mellitus
- Controlled hypertension
- Hpokalemia
- Risk of metabolic acidosis
- Ketogenic diet
- Severe respiratory disease
- Status epilepticus
- Surgery
- Diarrhea
- Dehydration
- High environmental temperature
- Alcohol use
- Renal impairment
- Hepatic impairment
Supplemental Patient Information
- Instruct patients that therapy is indicated for chronic weight management in conjunction with a reduced-calorie diet and increased physical activity
- Instruct patients to avoid pregnancy/breastfeeding while on therapy and to inform physician immediately if thye become pregnant during treatment
Pregnancy Category:X
Breastfeeding: Topiramate: Limited data indicates that maternal doses 
200 mg/day produce relatively low levels in infant serum. Monitor breastfed infant for drowsiness, adequate weight gain, and developmental milestones, (especially in exclusively breastfed infants or if mother taking combinations of anticovulsant/psychotropic drugs. This information is based upon LactMed database (available at http://toxnet.nlm.nih.gov/cgi-bin/sis/htmlgen?LACT last accessed 17 December 2012). Due to the potential for serious adverse reactions in nursing infants, manufacturer recommends discontinuation of nursing or discontinuation of drug, taking into account the importance of the drug to the mother.
US Trade Name(s)
US Availability
Qsymia (phentermine/topiramate)
- ECAPS: 3.75 mg/23 mg
- ECAPS: 7.5 mg/46 mg
- ECAPS: 15 mg/92 mg
- ECAPS: 11.25 mg/69 mg
Canadian Trade Name(s)
Canadian Availability
UK Trade Name(s)
UK Availability
Australian Trade Name(s)
Australian Availability
[Outline]
3% baseline body weight, discontinue or escalate dose