levamlodipine (Rx)

Brand and Other Names:Conjupri
  • Print

Dosing & Uses

AdultPediatricGeriatric

tablet

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

Hypertension

Indicated as monotherapy or in combination with other antihypertensive agents for hypertension

Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarction

Initial: 2.5 mg PO qDay;: may increase to up to 5 mg PO qDay

Small, fragile, or elderly patients, or patients with hepatic insufficiency, may be started on 1.25 mg qDay and this dose may be used when adding to other antihypertensive therapy

Adjust dosage according to blood pressure goals

In general, wait 7-14 days between titration steps; titrate more rapidly, if clinically warranted, provided the patient is assessed frequently

Dosage Modifications

Renal impairment

  • Pharmacokinetics of amlodipine are not significantly influenced
  • No dosage adjustment required in patients with renal failure

Hepatic impairment

  • Patients with hepatic insufficiency may be started on 1.25 mg qDay
  • Elderly patient and patients with hepatic insufficiency have decreased clearance of amlodipine with a resulting increase in AUC of ~40-–60%, and a lower initial dose may be required

tablet

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

Hypertension

Indicated as monotherapy or in combination with other antihypertensive agents for hypertension in children and adolescents aged ≥6 years

Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarction

<6 years: Safety and efficacy not established

6-17 years

  • 1.25-2.5 mg PO qDay
  • Doses >2.5 mg/day have not been studied in pediatric patients

Dosage Modifications

Renal impairment

  • Pharmacokinetics of amlodipine are not significantly influenced
  • No dosage adjustment required in patients with renal failure

Hepatic impairment

  • Patients with hepatic insufficiency may be started on 1.25 mg qDay
  • Patients with hepatic insufficiency have decreased clearance of amlodipine with a resulting increase in AUC of ~40-60%, and a lower initial dose may be required

Hypertension

Indicated as monotherapy or in combination with other antihypertensive agents for hypertension

Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarction

Small, fragile, or elderly patients may be started on 1.25 mg qDay and this dose may be used when adding to other antihypertensive therapy

Adjust dosage according to blood pressure goals

In general, wait 7-14 days between titration steps; titrate more rapidly if clinically warranted, provided the patient is assessed frequently

Next:

Interactions

Interaction Checker

and levamlodipine

No Results

     activity indicator 
    No Interactions Found
    Interactions Found

    Contraindicated

      Serious - Use Alternative

        Significant - Monitor Closely

          Minor

            All Interactions Sort By:
             activity indicator 
            Previous
            Next:

            Adverse Effects

            >10%

            • Edema (5.4-14.6%)

            1-10%

            • Fatigue (4.5%)
            • Flushing (1.5-4.5%)
            • Palpitations (0.7-4.5%)
            • Dizziness (1.1-3.4%)
            • Palpitations (1.4-3.3%)
            • Nausea (2.9%)
            • Flushing (0.7-2.6%)
            • Abdominal pain (1.6%)
            • Somnolence (1.3-1.6%)
            • Somnolence (1.4%)

            Frequency Not Defined

            Cardiovascular: Arrhythmia (eg, ventricular tachycardia, atrial fibrillation), bradycardia, chest pain, peripheral ischemia, syncope, tachycardia, vasculitis

            Central and peripheral nervous system: Hypoesthesia, neuropathy peripheral, paresthesia, tremor, vertigo

            Gastrointestinal: Anorexia, constipation, dysphagia, diarrhea, flatulence, pancreatitis, vomiting, gingival hyperplasia

            General: Allergic reaction, asthenia, back pain, hot flushes, malaise, pain, rigors, weight gain, weight decrease

            Musculoskeletal system: Arthralgia, arthrosis, muscle cramps, myalgia

            Psychiatric: Sexual dysfunction (male and female), insomnia, nervousness, depression, abnormal dreams, anxiety, depersonalization

            Respiratory system: Dyspnea, epistaxis

            Skin and appendages: Angioedema, erythema multiforme, pruritus, rash, erythematous rash, maculopapular rash

            Special senses: Abnormal vision, conjunctivitis, diplopia, eye pain, tinnitus

            Urinary system: Micturition frequency, micturition disorder, nocturia

            Autonomic nervous system: Dry mouth, sweating increased

            Metabolic and nutritional: Hyperglycemia, thirst

            Hemopoietic: Leukopenia, purpura, thrombocytopenia

            Postmarketing Reports

            Gynecomastia

            Jaundice and hepatic enzyme elevations (mostly consistent with cholestasis or hepatitis)

            Previous
            Next:

            Warnings

            Contraindications

            Hypersensitivity

            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 hr in patients with impaired hepatic function; titrate slowly when administering amlodipine to patients with severe hepatic impairment

            Drug interaction overview

            • Levoamlodipine 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 dose when appropriate
            Previous
            Next:

            Pregnancy & Lactation

            Pregnancy

            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

            Animal data

            • In animal reproduction studies, there was no evidence of adverse developmental effects when pregnant rats and rabbits were treated with oral amlodipine during organogenesis at doses ~10 and 20 times the maximum recommended human dose (MRHD)
            • In rats, litter size was significantly decreased (by about 50%), and the number of intrauterine deaths was significantly increased (about 5-fold)
            • Amlodipine has been shown to prolong both the gestation period and the duration of labor in rats at this dose

            Clinical considerations

            • Hypertension in pregnancy increases the maternal risk for preeclampsia, gestational diabetes, premature delivery, and delivery complications (eg, 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

            Pregnancy Categories

            A: Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.

            B: May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.

            C: Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.

            D: Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.

            X: Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.

            NA: Information not available.

            Previous
            Next:

            Pharmacology

            Mechanism of Action

            Amlodipine, a dihydropyridine calcium antagonist (calcium ion antagonist or slow-channel blocker), inhibits the transmembrane influx of calcium ions into vascular smooth muscle and cardiac muscle

            A peripheral arterial vasodilator that acts directly on vascular smooth muscle and causes a reduction in peripheral vascular resistance and reduction in blood pressure

            Absorption

            Peak plasma time: 6-12 hr

            Absolute bioavailability: 64-90%

            Steady-state: 7-8 days (consecutive day dosing)

            Distribution

            Protein bound: ~93%

            Metabolism

            Extensively (about 90%) converted to inactive metabolites via hepatic metabolism

            Elimination

            Half-life: 30-50 hr

            Previous
            Next:

            Administration

            Oral Administration

            Take with or without food

            Storage

            Store bottles at 20-25ºC (68-77ºF); excursions permitted to 15-30ºC (59-86ºF); dispense in tight, light-resistant containers

            Previous
            Next:

            Images

            Previous
            Next:

            Formulary

            FormularyPatient Discounts

            Adding plans allows you to compare formulary status to other drugs in the same class.

            To view formulary information first create a list of plans. Your list will be saved and can be edited at any time.

            Adding plans allows you to:

            • View the formulary and any restrictions for each plan.
            • Manage and view all your plans together – even plans in different states.
            • Compare formulary status to other drugs in the same class.
            • Access your plan list on any device – mobile or desktop.

            The above information is provided for general informational and educational purposes only. Individual plans may vary and formulary information changes. Contact the applicable plan provider for the most current information.

            Tier Description
            1 This drug is available at the lowest co-pay. Most commonly, these are generic drugs.
            2 This drug is available at a middle level co-pay. Most commonly, these are "preferred" (on formulary) brand drugs.
            3 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs.
            4 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
            5 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
            6 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
            NC NOT COVERED – Drugs that are not covered by the plan.
            Code Definition
            PA Prior Authorization
            Drugs that require prior authorization. This restriction requires that specific clinical criteria be met prior to the approval of the prescription.
            QL Quantity Limits
            Drugs that have quantity limits associated with each prescription. This restriction typically limits the quantity of the drug that will be covered.
            ST Step Therapy
            Drugs that have step therapy associated with each prescription. This restriction typically requires that certain criteria be met prior to approval for the prescription.
            OR Other Restrictions
            Drugs that have restrictions other than prior authorization, quantity limits, and step therapy associated with each prescription.
            Additional Offers
            Email to Patient

            From:

            To:

            The recipient will receive more details and instructions to access this offer.

            By clicking send, you acknowledge that you have permission to email the recipient with this information.

            Email Forms to Patient

            From:

            To:

            The recipient will receive more details and instructions to access this offer.

            By clicking send, you acknowledge that you have permission to email the recipient with this information.

            Previous
            Medscape prescription drug monographs are based on FDA-approved labeling information, unless otherwise noted, combined with additional data derived from primary medical literature.