Levoamlodipine

Levamlodipine is a prescription medication used alone or in combination with other antihypertensive agents for the treatment of hypertension (high blood pressure).

• Levamlodipine is available under the following different brand names: Conjupri

Common side effects of Levamlodipine include:

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

Serious side effects of Levamlodipine include:

• hives
• difficulty breathing
• swelling of the face, lips, tongue, or throat
• fast, irregular, or pounding heartbeat
• fainting
• worsening chest pain
• pain in the chest, jaw, or left arm
• shortness of breath
• unusual sweating

Rare side effects of Levamlodipine include:

• none 

Seek medical care or call 911 at once if you have the following serious side effects:

• Severe headache, confusion, slurred speech, arm or leg weakness, trouble walking, coordination loss, unsteady, very stiff muscles, high fever, profuse sweating, or tremors;
• Serious eye symptoms such as sudden vision loss, blurred vision, tunnel vision, eye pain or swelling, or seeing halos around lights;
• Serious heart symptoms include fast, irregular, or pounding heartbeats; fluttering in the chest; shortness of breath; sudden dizziness, lightheadedness, or passing out.

This is not a complete list of side effects and other serious side effects or health problems that may occur because of the use of this drug. Call your doctor for medical advice about serious side effects or adverse reactions. You may report side effects or health problems to FDA at 1-800-FDA-1088.

Adult and pediatric dosage

Tablet

• 1.25 mg
• 2.5 mg (functionally scored)
• 5 mg (functionally scored)

Hypertension

Adult dosage

• Initial: 2.5 mg orally once a day; may increase to up to 5 mg orally once a day
• Small, fragile, or elderly patients, or patients with hepatic insufficiency may be started on 1.25 mg orally once a day and this dose may be used when added to other antihypertensive therapy

Pediatric dosage

• Children younger than 6 years: Safety and efficacy not established
• Children aged between 6 and 17 years
• 1.25–2.5 mg orally once a day
• Doses more than 2.5 mg/day have not been studied in pediatric patients

Dosage Considerations – Should be Given as Follows: 

• See “Dosages”

If your medical doctor is using this medicine to treat your pain, your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop, or change the dosage of any medicine before checking with your doctor, healthcare provider, or pharmacist first.

• Levamlodipine has severe interactions with the following drug:
  • dantrolene
• Levamlodipine has serious interactions with the following drugs:
  • abametapir
  • fexinidazole
  • grapefruit
  • tucatinib
• Levamlodipine has moderate interactions with at least 99 other drugs
• Levamlodipine has minor interactions with the following drugs:
  • acetazolamide
  • anastrozole
  • bicalutamide
  • cyclophosphamide

This information does not contain all possible interactions or adverse effects. Visit the RxList Drug Interaction Checker for any drug interactions. Therefore, before using this product, tell your doctor or pharmacist about all the products you use. Keep a list of all your medications with you and share this information with your doctor and pharmacist. Check with your healthcare professional or doctor for additional medical advice, health questions, or concerns.

Contraindications

• Hypersensitivity

Effects of drug abuse

• None

Short-Term Effects

• See “What Are Side Effects Associated with Using Levamlodipine?”

Long-Term Effects

• See “What Are Side Effects Associated with Using Levamlodipine?”

Cautions

• Symptomatic hypotension is possible, particularly in patients with severe aortic stenosis; owing to 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
• Amlodipine is extensively metabolized by the liver; plasma elimination half-life is 56 hours in patients with impaired hepatic function; titrate slowly when administering amlodipine to patients with severe hepatic impairment
• Drug interaction overview
  • Levamlodipine is a CYP3A4 substrate
  • Effects of other drugs on amlodipine
    • Coadministration with moderate or strong CYP3A inhibitors results in increased systemic exposure to amlodipine and may require dose reduction; monitor for symptoms of hypotension and edema when amlodipine is coadministered with CYP3A inhibitors
    • No information is available on the quantitative effects of CYP3A inducers on amlodipine; closely monitor blood pressure when amlodipine is coadministered with CYP3A inducers
    • Monitor for hypotension when sildenafil is coadministered with amlodipine
  • Effects of amlodipine on other drugs
    • Coadministration of simvastatin with amlodipine increases the systemic exposure of simvastatin; limit simvastatin dose in patients on amlodipine to 20 mg/day
    • Amlodipine may increase the systemic exposure of cyclosporine or tacrolimus when coadministered; frequently monitor trough blood levels of cyclosporine and tacrolimus and adjust the dose when appropriate

Pregnancy and Lactation

• Limited available data based on postmarketing reports with 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
• Clinical considerations
  • Hypertension in pregnancy increases the maternal risk for preeclampsia, gestational diabetes, premature delivery, and delivery complications (e.g., need for cesarean delivery, postpartum hemorrhage)
  • Hypertension increases the fetal risk for intrauterine growth restriction and intrauterine death
  • Carefully monitor pregnant women with hypertension and managed accordingly
  • Lactation
  • 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
  • No information available on the effects of amlodipine on milk production