The first and Only FDA-Approved

Amlodipine Oral Suspension

for pediatric patients 6 years of age and older

From Silvergate Pharmaceuticals, delivering high-quality medications specifically for pediatric patients.

CALCIUM CHANNEL BLOCKER

The first and Only FDA-Approved

Amlodipine Oral Suspension

for pediatric patients 6 years of age and older

From Silvergate Pharmaceuticals, delivering high-quality medications specifically for pediatric patients.

READY TO USE. SIMPLY SHAKE.

  • Proven efficacy and safety in pediatric patients 6 years of age and older.
  • Easy dosing for pediatric patients and caregivers.
  • No compounding, crushing, or mixing necessary.
  • Consistent potency when stored and dosed as directed.

Quality and Consistency of an FDA-Approved Oral Suspension

The FDA is reinforcing the importance of prescribing an FDA-approved product such as Katerzia.
According to the FDA:

“When a drug is FDA-approved, patients are assured that the FDA has reviewed the safety and efficacy of the drug and the adequacy of the manufacturing process to produce a quality product … compounded drugs do not provide such assurance and, therefore, should only be used when an FDA-approved product is not available to meet the medical needs of an individual patient.” [Hamburg letter, 2014].

The FDA approval process helps ensure safety and effectiveness for your pediatric patients.

FDA-Approved Medications Differ from Compounded Drugs

*Current Good Manufacturing Practices

IMPORTANT SAFETY INFORMATION

INDICATIONS

KATERZIA is a calcium channel blocker and may be used alone or in combination with other antihypertensive and antianginal agents for the treatment of:

  • Hypertension in adults and children 6 years of age and older, to lower blood pressure:
    • Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions.
  • Coronary Artery Disease:
    • Chronic stable angina.
    • Vasospastic angina (Prinzmetal’s or variant angina).
    • Angiographically documented coronary artery disease in patients without heart failure or an ejection fraction < 40%.

ADDITIONAL IMPORTANT SAFETY INFORMATION

Contraindications:

Katerzia is contraindicated in patients with known sensitivity to amlodipine or to the inactive ingredients.

Warnings and Precautions:

  • Symptomatic hypotension is possible, particularly in patients with severe aortic stenosis. Because of the gradual onset of action, acute hypotension is unlikely.
  • Worsening angina and acute myocardial infarction can develop after starting or increasing the dose of amlodipine, particularly in patients with severe obstructive coronary artery disease.
  • Because amlodipine is extensively metabolized by the liver, and the plasma elimination half-life is 56 hours in patients with impaired hepatic function, titrate slowly when administering Katerzia to patients with severe hepatic impairment.

Adverse Reactions: See full Prescribing Information for additional adverse reactions.

  • The most common dose-related adverse reaction to amlodipine is edema.
  • Incidents of dose-related dizziness, flushing, and palpitation also have been observed.
  • For several reported adverse experiences that appear to be dose- and drug-related (edema, flushing, palpitations), there was a higher incidence associated with amlodipine treatment in women than in men.
  • Other adverse experiences not dose-related but reported are fatigue, nausea, abdominal pain, and somnolence.

Drug Interactions:

Impact of Amlodipine on Other Drugs

  • Co-administration of simvastatin with amlodipine increases the systemic exposure of simvastatin. Limit the dose of simvastatin in patients on amlodipine to 20 mg daily.
  • Amlodipine may increase the systemic exposure of cyclosporine or tacrolimus when co-administered. Frequent monitoring of trough blood levels of cyclosporine and tacrolimus is recommended. Adjust the dose accordingly when appropriate.

Impact of Other Drugs on Amlodipine

  • Co-administration with CYP3A inhibitors (moderate and strong) results in increased systemic exposure to amlodipine and may require dose reduction. Monitor for symptoms of hypotension and edema when amlodipine is co-administered with CYP3A inhibitors to determine the need for dose adjustment.
  • Blood pressure should be closely monitored when amlodipine is co-administered with CYP3A inducers.

Important Limitations in Specific Populations:

Pediatric Use

  • The effective antihypertensive oral dose in pediatric patients ages 6 to 17 years is 2.5 mg to 5 mg once daily. Doses in excess of 5 mg daily have not been studied in pediatric patients.
  • The effect of amlodipine in patients less than 6 years of age is not known.

Geriatric Use

  • In general, dose selection for elderly patients should be cautious, usually starting with a lower initial dose.

Hepatic Impairment

  • A lower initial dose may be required for patients with hepatic insufficiency.

Pregnancy

  • Limited data on post-marketing use of amlodipine in pregnant women are not sufficient to inform a drug-associated risk for major birth defects or miscarriages. There are risks to the mother and fetus associated with poorly controlled hypertension during pregnancy. See full Prescribing Information.

Lactation

  • Limited available data from a published clinical lactation study reports that amlodipine is present in human milk. No adverse effects of amlodipine on the breastfed infant have been observed.

SHAKE BEFORE USING.

Refrigerate at 2°C to 8°C/36°F to 46°F. Avoid freezing and excessive heat. Protect from light.

Please see full Prescribing Information for complete information.

To report SUSPECTED ADVERSE REACTIONS, contact Silvergate Pharmaceuticals at 1-855-379-0383, or FDA at 1-800-FDA-1088 or www.fda.gov/MedWatch.

Keep this and all medications out of the reach of children.