Conjupri

Generic name: levamlodipine
Drug class: Calcium channel blocking agents

What is Conjupri?

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.

Description

The active ingredient levamlodipine maleate is the maleate salt of levamlodipine, the pharmacologically active isomer of amlodipine, a long-acting calcium channel blocker.

Levamlodipine maleate is chemically described as (S)3-ethyl-5-methyl-2-(2-aminoethoxymethyl)-4-(2-chlorophenyl)-1,4-dihydro-6-methyl-3,5-pyridinedicarboxylate maleate, and its structural formula is:

Levamlodipine maleate is an off-white to light yellow crystalline powder with a molecular weight of 524.95. It is slightly soluble in water and sparingly soluble in ethanol. CONJUPRI® (Levamlodipine) tablets are formulated as white to off-white tablets containing 1.25, 2.5, and 5 mg of levamlodipine (equivalent to 1.6, 3.2, and 6.4 mg of levamlodipine maleate respectively), for oral administration. In addition to the active ingredient, levamlodipine maleate, each tablet contains the following inactive ingredients: betadex, colloidal silicon dioxide, magnesium stearate, microcrystalline cellulose, and pregelatinized starch.

Mechanism of Action

Amlodipine is a dihydropyridine calcium antagonist (calcium ion antagonist or slow-channel blocker) that inhibits the transmembrane influx of calcium ions into vascular smooth muscle and cardiac muscle. Experimental data suggest that amlodipine binds to both dihydropyridine and nondihydropyridine binding sites. The contractile processes of cardiac muscle and vascular smooth muscle are dependent upon the movement of extracellular calcium ions into these cells through specific ion channels. Amlodipine inhibits calcium ion influx across cell membranes selectively, with a greater effect on vascular smooth muscle cells than on cardiac muscle cells.

Negative inotropic effects can be detected in vitro but such effects have not been seen in intact animals at therapeutic doses. Serum calcium concentration is not affected by amlodipine. Within the physiologic pH range, amlodipine is an ionized compound (pKa=8.6), and its kinetic interaction with the calcium channel receptor is characterized by a gradual rate of association and dissociation with the receptor binding site, resulting in a gradual onset of effect.

Amlodipine is a peripheral arterial vasodilator that acts directly on vascular smooth muscle to cause a reduction in peripheral vascular resistance and reduction in blood pressure.

Amlodipine is a 1:1 racemic mixture of levamlodipine and dextro amlodipine, it has been demonstrated that levamlodipine is the pharmacologically active, anti-hypertensive isomer.

Who should not take Conjupri?

Do not take Conjupri if you are allergic to amlodipine or to any of the ingredients in Conjupri. See the end of this Patient guide for a complete list of ingredients in Conjupri.

What should I tell my healthcare provider before taking Conjupri?

Before taking Conjupri, tell your healthcare provider about all of your medical conditions, including if you:

• have heart problems
• have liver problems
• are pregnant or plan to become pregnant. It is not known if Conjupri can harm your unborn baby. Tell your healthcare provider if you become pregnant during treatment with Conjupri.
• are breastfeeding or plan to breastfeed. Conjupri can pass into your breast milk. Talk to your healthcare provider about the best way to feed your baby during treatment with Conjupri.

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

How should I take Conjupri?

• Take Conjupri exactly as your healthcare provider tell you to.
• Take Conjupri 1 time a day.
• If you take too much Conjupri, contact your local poison control center or go to the nearest hospital emergency room right away.

What are the possible side effects of Conjupri?

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.

General information about the safe and effective use of Conjupri

Medicines are sometimes prescribed for purposes other than those listed in a Patient Information guide. Do not use Conjupri for a condition for which it was not prescribed. Do not give Conjupri to other people, even if they have the same symptoms that you have. It may harm them. You can ask your pharmacist or healthcare provider for information about Conjupri that is written for health professionals.

How should I store Conjupri?

• Store Conjupri at 68°F to 77°F (20°C to 25°C).
• Keep Conjupri out of the light.

Keep Conjupri and all medicines out of the reach of children.

What are the ingredients in Conjupri?

Active ingredient: levamlodipine maleate

Inactive ingredients: betadex, colloidal silicon dioxide, magnesium stearate, microcrystalline cellulose, and pregelatinized starch

For more information, call 1-877-436-7220.