Consensi (amlodipine/celecoxib): Side Effects & Interactions

Generic drug: amlodipine and celecoxib

Brand name: Consensi

What is Consensi (amlodipine and celecoxib), and how does it work?

Consensi (amlodipine and celecoxib) is a prescription medicine used in adults who need treatment:

with amlodipine for high blood pressure (hypertension), to lower blood pressure, and
with celecoxib for the management of the signs and symptoms of osteoarthritis.

It is not known if Consensi is safe and effective in children.

What are the side effects of Consensi?

WARNING

RISK OF SERIOUS CARDIOVASCULAR and GASTROINTESTINAL EVENTS

Cardiovascular Thrombotic Events

Nonsteroidal anti-inflammatory drugs (NSAIDs) cause an increased risk of
serious cardiovascular (CV) thrombotic events, including myocardial
infarction (MI), and stroke, which can be fatal. This risk may occur early
in the treatment and may increase with duration of use.
Consensi is
contraindicated in the setting of coronary artery bypass graft (CABG)
surgery.

Gastrointestinal Bleeding, Ulceration, and Perforation

NSAIDs cause an increased risk of serious gastrointestinal (GI) adverse
events including bleeding, ulceration, and perforation of the stomach or
intestines, which can be fatal. These events can occur at any time during
use and without warning symptoms. Elderly patients and patients with a prior
history of peptic ulcer disease and/or GI bleeding are at greater risk for
serious GI events.

Consensi can cause serious side effects, including:

liver problems, including liver failure
worsening chest pain (angina) or heart attack, particularly in people with severe obstructive coronary artery disease
heart failure
swelling of your arms, legs, hands and feet (peripheral edema) is common with Consensi but can sometimes be serious.
kidney problems, including kidney failure
increased potassium levels (hyperkalemia)
life-threatening allergic reactions
life-threatening skin reactions
low red blood cells (anemia)

Your healthcare provider will monitor your blood pressure and do blood tests to check you for side effects during treatment with Consensi.

Consensi may cause fertility problems in females that is reversible when treatment with Consensi is stopped. Talk to your healthcare provider if this is a concern for you.

The most common side effects of Consensi include:

swelling of the arms, legs, hands, and feet
joint swelling
dizziness
stomach pain
diarrhea
heartburn
headache
frequent urination
hot or warm feeling in your face (flushing)
gas
tiredness
extreme sleepiness

Get emergency help right away if you get any of the following symptoms:

shortness of breath or trouble breathing
chest pain
weakness in one part or side of your body
slurred speech
swelling of the face or throat

Stop taking Consensi and call your healthcare provider right away if you get any of the following symptoms:

nausea
more tired or weaker than usual
diarrhea
itching
indigestion or stomach pain
flu-like symptoms
vomit blood
there is blood in your bowel movement or it is black and sticky like tar
unusual weight gain
your skin or eyes look yellow
skin rash or blisters with fever
swelling of the arms, legs, hands and feet

These are not all the possible side effects of Consensi.

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

What is the dosage for Consensi?

Recommended Dosage

Use the lowest effective dosage of celecoxib for the shortest duration
consistent with individual patient treatment goals. Only 200 mg of celecoxib once daily is available with
Consensi.
Start Consensi in adults at (amlodipine/celecoxib) 5 mg/200 mg orally once daily or 2.5 mg/200 mg in small, fragile, or elderly patients, or patients with mild hepatic insufficiency. Use 2.5 mg/200 mg when adding
Consensi to other antihypertensive therapy.
Adjust amlodipine component dosage according to blood pressure goals. In general, wait 7 to 14 days between titration steps. If more rapid titration is clinically warranted, monitor closely. The maximum dose is 10 mg/200 mg once daily.

Discontinuation

If analgesic therapy is no longer indicated, discontinue Consensi and initiate patient on alternative antihypertensive therapy, such as amlodipine monotherapy. If
Consensi is stopped and replaced with an equal dose of amlodipine, monitor blood pressure carefully.

Replacement Therapy

For patients receiving celecoxib and amlodipine from separate capsules and tablets, respectively, substitute
Consensi containing the same component doses. Monitor blood pressure carefully.

QUESTION

Salt and sodium are the same.
See Answer

What drugs interact with Consensi?

Celecoxib

Clinically significant drug interactions with celecoxib are shown in the following table:

Drugs That Interfere with Hemostasis

Clinical Impact:

Celecoxib and anticoagulants such as warfarin have a synergistic effect on bleeding. The concomitant use of celecoxib and anticoagulants have an increased risk of serious bleeding compared to the use of either drug alone.
Serotonin release by platelets plays an important role in hemostasis. Case-control and cohort epidemiological studies showed that concomitant use of drugs that interfere with serotonin reuptake and an NSAID may potentiate the risk of bleeding more than an NSAID alone.

Intervention:
Monitor patients with concomitant use of celecoxib with
anticoagulants (e.g., warfarin), antiplatelet drugs (e.g., aspirin),
SSRIs, and SNRIs for signs of bleeding.

Aspirin

Clinical Impact:
Controlled clinical studies showed that the concomitant use of
NSAIDs and analgesic doses of aspirin does not produce any greater
therapeutic effect than the use of NSAIDs alone. In a clinical
study, the concomitant use of an NSAID and aspirin was associated
with a significantly increased incidence of GI adverse reactions as
compared to use of the NSAID alone. In two studies in healthy volunteers, and in patients with osteoarthritis and established heart disease respectively, celecoxib (200-400 mg daily) has demonstrated a lack of interference with the cardioprotective antiplatelet effect of aspirin (100-325 mg).

Intervention:
Concomitant use of celecoxib and analgesic doses of aspirin is
not generally recommended because of the increased risk of bleeding. Celecoxib is not a substitute for low dose aspirin for CV protection.

ACE Inhibitors, Angiotensin Receptor Blockers, and Beta-Blockers

Clinical Impact:

NSAIDs may diminish the antihypertensive effect of ACE inhibitors, ARBs, orbeta-blockers (including propranolol).
In patients who are elderly, volume-depleted (including those on diuretic therapy), or have renal impairment, co-administration of an NSAID with ACE inhibitors or ARBs may result in deterioration of renal function, including possible acute renal failure. These effects are usually reversible.

Intervention:

During concomitant use of celecoxib and ACE-inhibitors, ARBs, or beta-blockers, monitor blood pressure to ensure that the desired blood pressure is obtained.
During concomitant use of celecoxib and ACE-inhibitors or
ARBs in patients who are elderly, volume-depleted, or have
impaired renal function, monitor for signs of worsening renal
function.
When these drugs are administered concomitantly, patients should be adequately hydrated. Assess renal function at the beginning of the concomitant treatment and periodically thereafter.

Diuretics

Clinical Impact:
Clinical studies, as well as post-marketing observations, showed that NSAIDs reduced the natriuretic effect of loop diuretics (e.g., furosemide) and thiazide diuretics in some patients. This effect has been attributed to the NSAID inhibition of renal prostaglandin synthesis.

Intervention:
During concomitant use of celecoxib with diuretics, observe
patients for signs of worsening renal function, in addition to
assuring diuretic efficacy including antihypertensive effects.

Digoxin

Clinical Impact:
The concomitant use of celecoxib with digoxin has been reported to increase the serum concentration and prolong the half-life of digoxin.

Intervention:
During concomitant use of celecoxib and digoxin, monitor serum digoxin levels.

Lithium

Clinical Impact:
NSAIDs have produced elevations in plasma lithium levels and reductions in renal lithium clearance. The mean minimum lithium concentration increased 15%, and the renal clearance decreased by approximately 20%. This effect has been attributed to NSAID inhibition of renal prostaglandin synthesis.

Intervention:
During concomitant use of celecoxib and lithium, monitor patients for signs of lithium toxicity.

Methotrexate

Clinical Impact:
Concomitant use of NSAIDs and methotrexate may increase the risk for methotrexate toxicity (e.g., neutropenia, thrombocytopenia, renal dysfunction). Celecoxib has no effect on methotrexate pharmacokinetics.

Intervention:
During concomitant use of celecoxib and methotrexate, monitor patients for methotrexate toxicity.

Cyclosporine

Clinical Impact:
Concomitant use of celecoxib and cyclosporine may increase cyclosporine's nephrotoxicity.

Intervention:
During concomitant use of celecoxib and cyclosporine, monitor patients for signs of worsening renal function.

NSAIDs and Salicylates

Clinical Impact:
Concomitant use of celecoxib with other NSAIDs or salicylates
(e.g., diflunisal, salsalate) increases the risk of GI toxicity,
with little or no increase in efficacy.

Intervention:
The concomitant use of celecoxib with other NSAIDs or salicylates is not recommended.

Pemetrexed

Clinical Impact:
Concomitant use of celecoxib and pemetrexed may increase the risk of pemetrexed-associated myelosuppression, renal, and GI toxicity (see the pemetrexed prescribing information).

Intervention:
During concomitant use of celecoxib and pemetrexed, in patients with renal impairment whose creatinine clearance ranges from 45 to 79 mL/min, monitor for myelosuppression, renal and GI toxicity. NSAIDs with short elimination half-lives (e.g., diclofenac, indomethacin) should be avoided for a period of two days before, the day of, and two days following administration of pemetrexed. In the absence of data regarding potential interaction between pemetrexed and NSAIDs with longer half-lives (e.g., meloxicam, nabumetone), patients taking these NSAIDs should interrupt dosing for at least five days before, the day of, and two days following pemetrexed administration.

CYP2C9 Inhibitors or Inducers

Clinical Impact:
Celecoxib metabolism is predominantly mediated via CYP2C9 in the liver. Coadministration of celecoxib with drugs that are known to inhibit CYP2C9 (e.g. fluconazole) may enhance the exposure and toxicity of celecoxib whereas co-administration with CYP2C9 inducers (e.g. rifampin) may lead to compromised efficacy of celecoxib.

Intervention:
Evaluate each patient’s medical history when consideration is
given to prescribing celecoxib. A dosage adjustment may be warranted
when celecoxib is administered with CYP2C9 inhibitors or inducers.

CYP2D6 Substrates

Clinical Impact:
In vitro studies indicate that celecoxib, although not a substrate, is an inhibitor of CYP2D6. Therefore, there is a potential for an in vivo drug interaction with drugs that are metabolized by CYP2D6 (e.g. atomoxetine), and celecoxib may enhance the exposure and toxicity of these drugs.

Corticosteroids

Clinical Impact:
Concomitant use of corticosteroids with celecoxib may increase the risk of GI ulceration or bleeding.

Intervention:
Monitor patients with concomitant use of celecoxib with
corticosteroids for signs of bleeding.

Amlodipine

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.

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.

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Is Consensi safe to use while pregnant or breastfeeding?

Use of NSAIDs, including Consensi, can cause premature closure of the fetal ductus arteriosus and fetal renal dysfunction leading to oligohydramnios and, in some cases, neonatal renal impairment.
Because of these risks, limit dose and duration of Consensi use between about 20 and 30 weeks of gestation and avoid
Consensi use at about 30 weeks of gestation and later in pregnancy.
The available published literature report the individual components of
Consensi (celecoxib, amlodipine) are present in human breast milk at low levels.
No adverse effects of amlodipine were observed in the breastfed infants.
There is no available information on the effects of celecoxib or amlodipine on milk production.

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