Conjupri

Last updated on RxList: 7/21/2021
Conjupri Side Effects Center

What Is Conjupri?

Conjupri (levamlodipine) is calcium channel blocker and may be used alone or in combination with other antihypertensive agents for the treatment of high blood pressure (hypertension), to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions.

What Are Side Effects of Conjupri?

Side effects of Conjupri include:

  • fluid retention (edema),
  • fatigue,
  • nausea,
  • abdominal pain,
  • flushing,
  • palpitations, and
  • drowsiness

Dosage for Conjupri

The adult recommended starting dose of Conjupri is 2.5 mg orally once daily with a maximum dose of 5 mg once daily. Small, fragile, or elderly patients, or patients with hepatic insufficiency may be started on 1.25 mg once daily. The pediatric starting dose of Conjupri is 1.25 mg to 2.5 mg once daily.

Conjupri In Children

Conjupri (1.25 to 2.5 mg daily) is effective in lowering blood pressure in patients 6 to 17 years. The effect of Conjupri on blood pressure in patients less than 6 years of age is not known.

What Drugs, Substances, or Supplements Interact with Conjupri?

Conjupri may interact with other medicines such as:

  • moderate and strong CYP3A inhibitors,
  • CYP3A inducers,
  • sildenafil,
  • simvastatin,
  • cyclosporine, and
  • tacrolimus

Tell your doctor all medications and supplements you use.

Conjupri During Pregnancy and Breastfeeding

Tell your doctor if you are pregnant or plan to become pregnant before using Conjupri; it is unknown how it would affect a fetus. Conjupri passes into breast milk. No adverse effects of Conjupri on breastfed infants have been observed. There is no available information on the effects of Conjupri on milk production. Consult your doctor before breastfeeding.

Additional Information

Our Conjupri (levamlodipine) Tablets, for Oral Use Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

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Conjupri Consumer Information

Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

In rare cases, when you first start taking levamlodipine, your angina may get worse or you could have a heart attack. Seek emergency medical attention or call your doctor right away if you have symptoms such as: chest pain or pressure, pain spreading to your jaw or shoulder, nausea, sweating.

Call your doctor at once if you have:

  • pounding heartbeats or fluttering in your chest;
  • worsening chest pain; or
  • a light-headed feeling, like you might pass out.

Common side effects may include:

  • fast heartbeats;
  • swelling in your feet or ankles;
  • dizziness, drowsiness;
  • feeling tired;
  • stomach pain, nausea; or
  • flushing (warmth, redness, or tingly feeling).

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Read the entire detailed patient monograph for Conjupri (Levamlodipine Tablets)

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Conjupri Professional Information

SIDE EFFECTS

Clinical Trials Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.

Amlodipine has been evaluated for safety in more than 11,000 patients in U.S. and foreign clinical trials. In general, treatment with amlodipine besylate was well-tolerated at doses up to 10 mg daily. Most adverse reactions reported during therapy with amlodipine were of mild or moderate severity. In controlled clinical trials directly comparing amlodipine besylate (N = 1730) at doses up to 10 mg to placebo (N = 1250), discontinuation of amlodipine besylate because of adverse reactions was required in only about 1.5% of patients and was not significantly different from placebo (about 1%). The most commonly reported side effects more frequent than placebo are reflected in the table below. The incidence (%) of side effects that occurred in a dose related manner are as follows:

Amlodipine Placebo
N=520
2.5mg
N=275
5mg
N=296
10mg
N=268
Edema 1.8 3.0 10.8 0.6
Dizziness 1.1 3.4 3.4 1.5
Flushing 0.7 1.4 2.6 0.0
Palpitation 0.7 1.4 4.5 0.6

Other adverse reactions that were not clearly dose related but were reported with an incidence greater than 1.0% in placebocontrolled clinical trials include the following:

Amlodipine (%)
(N=1730)
Placebo (%)
(N=1250)
Fatigue 4.5 2.8
Nausea 2.9 1.9
Abdominal Pain 1.6 0.3
Somnolence 1.4 0.6

For several adverse experiences that appear to be drug and dose related, there was a greater incidence in women than men associated with amlodipine treatment as shown in the following table:

Amlodipine (%) Placebo (%)
Male = %
(N=1218)
Female = %
(N=512)
Male = %
(N=914)
Female = %
(N=336)
Edema 5.6 14.6 1.4 5.1
Flushing 1.5 4.5 0.3 0.9
Palpitations 1.4 3.3 0.9 0.9
Somnolence 1.3 1.6 0.8 0.3

The following events occurred in <1% but >0.1% of patients in controlled clinical trials or under conditions of open trials or marketing experience where a causal relationship is uncertain; they are listed to alert the physician to a possible relationship:

Cardiovascular: arrhythmia (including ventricular tachycardia and 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,1 asthenia, back pain, hot flushes, malaise, pain, rigors, weight gain, weight decrease.

Musculoskeletal System: arthralgia, arthrosis, muscle cramps,1 myalgia.

Psychiatric: sexual dysfunction (male1 and female), insomnia, nervousness, depression, abnormal dreams, anxiety, depersonalization.

Respiratory System: dyspnea,1 epistaxis.

Skin and Appendages: angioedema, erythema multiforme, pruritus,1 rash,1 rash erythematous, rash maculopapular.

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.

Amlodipine therapy has not been associated with clinically significant changes in routine laboratory tests. No clinically relevant changes were noted in serum potassium, serum glucose, total triglycerides, total cholesterol, HDL cholesterol, uric acid, blood urea nitrogen, or creatinine.

In the CAMELOT and PREVENT studies of amlodipine in coronary artery disease, the adverse event profile was similar to that reported previously (see above), with the most common adverse event being peripheral edema.

Postmarketing Experience

Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

The following postmarketing event has been reported infrequently where a causal relationship is uncertain: gynecomastia. In postmarketing experience, jaundice and hepatic enzyme elevations (mostly consistent with cholestasis or hepatitis), in some cases severe enough to require hospitalization, have been reported in association with use of amlodipine.

Postmarketing reporting has also revealed a possible association between extrapyramidal disorder and amlodipine.

Amlodipine has been used safely in patients with chronic obstructive pulmonary disease, well-compensated congestive heart failure, coronary artery disease, peripheral vascular disease, diabetes mellitus, and abnormal lipid profiles.

DRUG INTERACTIONS

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 [see CLINICAL PHARMACOLOGY]

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 [see CLINICAL PHARMACOLOGY].

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 [see CLINICAL PHARMACOLOGY].

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 [see CLINICAL PHARMACOLOGY].

1 These events occurred in less than 1% in placebo-controlled trials, but the incidence of these side effects was between 1% and 2% in all multiple dose studies.

Read the entire FDA prescribing information for Conjupri (Levamlodipine Tablets)

© Conjupri Patient Information is supplied by Cerner Multum, Inc. and Conjupri Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.

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