Conjupri (levamlodipine)

Conjupri is a prescription medicine used to treat high blood pressure (hypertension) in adults and pediatric patients 6 years and older. Conjupri can be used by itself or with other high blood pressure medicines.

It is not known if Conjupri is safe and effective in children less than 6 years of age.

Conjupri may cause serious side effects, including:

• Low blood pressure (hypotension). Conjupri may cause low blood pressure, especially in people that have a condition called severe aortic stenosis. Tell your healthcare provider if you feel faint or lightheaded.
• Worsening chest pain (angina) or heart attack. Conjupri may cause worsening chest pain or heart attack after starting or increasing your dose, especially in people with a condition called severe obstructive coronary artery disease. If that happens, call your healthcare provider right away or go directly to a hospital emergency room.

The most common side effects of Conjupri include:

• swelling of your legs or ankles
• tiredness
• nausea
• stomach pain
• sleepiness
• dizziness
• flushing (hot or warm feeling in your face)
• heart palpitations (very fast heartbeat)

These are not all of the possible side effects of Conjupri.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Adults

• The usual initial antihypertensive oral dose of levamlodipine is 2.5 mg once daily, and the maximum dose is 5 mg once daily.
• Small, fragile, or elderly patients, or patients with hepatic insufficiency may be started on 1.25 mg once daily and this dose may be used when adding levamlodipine to other antihypertensive therapy.
• Adjust dosage according to blood pressure goals.
• In general, wait 7 to 14 days between titration (decreasing dosage) steps. Titrate more rapidly, however, if clinically warranted, provided the patient is assessed frequently.

Children

• The effective antihypertensive oral dose in pediatric patients ages 6-17 years is 1.25 mg to 2.5 mg once daily.
• Doses in excess of 2.5 mg daily have not been studied in pediatric patients.

Impact Of Other Drugs On Amlodipine

CYP3A Inhibitors

• 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.

CYP3A Inducers

• No information is available on the quantitative effects of CYP3A inducers on amlodipine.
• Blood pressure should be closely monitored when amlodipine is co-administered with CYP3A inducers.

Sildenafil

• Monitor for hypotension when sildenafil is co-administered with amlodipine.

Impact Of Amlodipine On Other Drugs

Simvastatin

• 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.

Immunosuppressants

• 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 and adjust the dose when appropriate.

• The limited available data based on post-marketing reports with amlodipine use in pregnant women are not sufficient to inform a drug-associated risk for major birth defects and miscarriage.
• There are risks to the mother and fetus associated with poorly controlled hypertension in pregnancy.
• Limited available data from a published clinical lactation study reports that amlodipine is present in human milk at an estimated median relative infant dose of 4.2%.
• No adverse effects of amlodipine on the breastfed infant have been observed.
• There is no available information on the effects of amlodipine on milk production.