Adult Dosing

Exogenous Obesity

Extended-release capsule

• 1 capsule (105 mg) PO, 30-60 minutes before breakfast

Immediate release

• 17.5-35 mg PO bid or tid 1 hr before meal
• Max: 70 mg PO tid

• Do not cut, crush, or chew the capsule
• Use lowest effective dose to obtain an adequate response; discontinue the drug if tolerance occurs

Pediatric Dosing

• Not recommended in pediatric patients <12 yrs of age

Exogenous Obesity (children >12 yrs of age)

Extended-release capsule

• 1 capsule (105 mg) PO, 30-60 minutes before breakfast

Immediate release

• 17.5-35 mg PO bid or tid 1 hr before meal
• Max: 70 mg PO tid

• Do not cut, crush, or chew the capsule
• Use lowest effective dose to obtain an adequate response; discontinue the drug if tolerance occurs

[Outline]

• Adult Dosing
• Pediatric Dosing

• Management of exogenous obesity as a short-term adjunct to a weight loss regimen based on caloric restriction in patients with an initial BMI of 30 kg/m² or higher who have not responded to appropriate regimen of weight loss (diet and/or exercise) alone

• Hypersensitivity to any of the ingredients of the product
• Known hypersensitivity or idiosyncrasy to sympathomimetic amines
• Advanced arteriosclerosis
• Symptomatic cardiovascular disease
• Moderate and severe hypertension
• Pulmonary hypertension
• Valvular heart disease
• Hyperthyroidism
• Glaucoma
• Highly nervous or agitated patients
• History of drug abuse
• Co-administration with other CNS stimulants including monoamine oxidase inhibitors
• Concomitant use with other anorectic agents
• Abrupt withdrawal
• Pregnancy
• Breastfeeding

• N/A

Renal Dose Adjustment

• Renal impairment: Dose adjustments not defined

Hepatic Dose Adjustment

• Hepatic impairment: Dose adjustments not defined

See Supplemental Patient Information

• Avoid use in combination with other anorectic agents, including prescribed drugs, over-the-counter preparations, and herbal products
• Rare cases of fatal pulmonary hypertension have been reported during therapy; this risk may increase with the use of anorectic agents for more than 3 months and with repeated courses of therapy; immediately discontinue therapy and evaluate the patient for the possible presence of pulmonary hypertension
• Valvular heart disease associated with the use of some anorectic agents has been reported; avoid using for extended periods of time, higher than recommended dose, and/or in combination with other anorectic drugs
• Carefully assess the potential benefits and risks of the drug before initiating treatment. Perform baseline cardiac evaluation to detect preexisting valvular heart diseases or pulmonary hypertension prior to therapy initiation. Perform echocardiogram during and after treatment for detecting any valvular disorders
• Avoid use in patients with known heart murmur, valvular heart disease, severely hypertensive patients or in patients with symptomatic cardiovascular disease including CAD, CHF, stroke, arrhythmias. Avoid use in patients who used any anorectic agents within the prior year
• To limit undue exposure and risks, continue treatment only if the patient has satisfactory weight loss within the first 4 weeks of treatment
• Abrupt cessation of therapy following prolonged high dosage may result in extreme fatigue and depression
• Therapy may impair the ability of the patient to perform potentially hazardous activities such as driving a motor vehicle or operating machinery
• Therapy may decrease the hypotensive effect of guanethidine; prescribe the least amount feasible at one time to minimize the possibility of overdosage
• Use of therapy within 14 days following the administration of MAOIs may cause hypertensive crisis
• Discontinue therapy on development of tolerance to the anorectic effect
• Alterations in insulin requirements in patients with diabetes mellitus may occur in association with therapy use and the concomitant dietary regimen

Cautions: Use cautiously in:

• Mild hypertension
• Diabetes mellitus
• Geriatric patients

Supplemental Patient Information

• Caution patients to refrain from driving a motor vehicle or operating machinery during therapy, as it may impair the ability of the patient to perform potentially hazardous activities

Pregnancy Category:C

Breastfeeding: It is unknown if this drug is excreted in human milk. Manufacturer advises mothers to refrain from breastfeeding unless, in the judgment of the physician, the potential benefits outweigh the possible hazards.

• CNS: Over-stimulation, restlessness, insomnia, agitation, tremor, dizziness, headache, abuse dependency
• PSYCHIATRY: Psychosis
• EENT: Blurring of vision
• CV: Palpitation, tachycardia, hypertension, ischemic events, pulmonary hypertension, valvular heart disease
• GI: Dryness of the mouth, nausea, diarrhea, constipation, stomach pain
• GU: Urinary frequency, dysuria, changes in libido
• DERM: Sweating, flushing
• MISC: Withdrawal if abruptly discontinued (high-dose, long-term use), tolerance

• Anorectic agent; precise mechanism of action unknown; may stimulate satiety center in brain, causing appetite suppression; also causes elevation of blood pressure
• Metabolized minimally in the liver
• Excreted in urine
• Half life:
• Immediate release: 1.9 hrs
• Extended release: 9.8 hrs

US Trade Name(s)

• Only generic available

US Availability

phendimetrazine tartrate (generic)

• ECAPS: 105 mg
• TABS: 35 mg

Bontril (generic)

• ECAPS: 105 mg

Bontril PDM (generic)

• TABS: 35 mg

Canadian Trade Name(s)

• N/A

Canadian Availability

• N/A

UK Trade Name(s)

• N/A

UK Availability

• N/A

Australian Trade Name(s)

• N/A

Australian Availability

• N/A

[Outline]

Endocrine/Metabolic

Anorexiants

• 24 HR Bontril 105 MG Extended Release Capsule (Apotheca, Inc.)
• 24 HR Bontril 105 MG Extended Release Capsule (Valeant Pharmaceuticals International)
• Bontril PDM 35 MG Oral Tablet (Valeant Pharmaceuticals, Inc.)
• Phendimetrazine 105 MG 24 HR Extended Release Capsule (Apotheca, Inc.)
• Phendimetrazine 105 MG 24 HR Extended Release Capsule (Physicians Total Care, Inc.)
• Phendimetrazine 105 MG 24 HR Extended Release Capsule (Sandoz Inc.)
• Phendimetrazine tartrate 35 MG Oral Tablet (Actavis Totowa LLC)
• Phendimetrazine tartrate 35 MG Oral Tablet (Apotheca, Inc.)
• Phendimetrazine tartrate 35 MG Oral Tablet (MIKART, INC.)