Label Changes for:

Phendimetrazine tartrate SR 105 mg capsules

February 2012

Changes have been made to the CONTRAINDICATIONS, PRECAUTIONS and ADVERSE REACTIONS sections of the safety label.

Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER) – February 2012

 

 

CONTRAINDICATIONS

  • History of cardiovascular disease and stroke, arrhythmias, and congestive heart disease
  • Pregnancy Category from C to X
  • Nursing

PRECAUTIONS

Nursing Mothers
  • It is not known if phendimetrazine tartrate is excreted in human milk. Phendimetrazine tartrate, a phenylalkylamine sympathomimetic amine, has pharmacological activity similar to the Amphetamines...
Pediatric Use
  • Because pediatric obesity is a chronic condition requiring long-term treatment, the use of phendimetrazine tartarate ER approved for short-term therapy, is not recommended in patients less than 17 years of age.
Renal Impairment
  • Phendimetrazine tartrate extended-release capsules were not studied in patients with renal impairment. As phendimetrazine tartrate is excreted in urine, exposure increases can be expected in patients with renal impairment. Use caution when administering phendimetrazine tartrate to patients with renal impairment.
Geriatric Use
  • In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting
Drug Interactions
  • Monoamine Oxidase Inhibitors
  • Use of phendimetrazine tartrate is contraindicated during or within 14 days following the administration of monoamine oxidase inhibitors because of the risk of hypertensive crisis.
  • Alcohol Concomitant use of alcohol with phendimetrazine tartrate may result in an adverse drug reaction.
  • Insulin and Oral Hypoglycemic Medications Requirements may be altered.
  • Adrenergic Neuron Blocking Drugs
  • phendimetrazine tartrate may decrease the hypotensive effect of adrenergic neuron blocking drugs.”

ADVERSE EVENTS

Cardiovascular
  • Primary pulmonary hypertension, and/or regurgitant cardiac valvular disease, palpitation, tachycardia, elevated blood pressure, and ischemic events
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