Drug Detail:Amlodipine and celecoxib (Amlodipine and celecoxib [ am-loe-di-peen-and-sel-e-kox-ib ])
Drug Class: Cox-2 inhibitors Miscellaneous antihypertensive combinations
Usual Adult Dose for Hypertension
Initial dose: Amlodipine 5 mg-Celecoxib 200 mg orally once a day
Maximum dose: Amlodipine 10 mg-Celecoxib 200 mg orally once a day
Comments: Allow 7 to 14 days between titration. If more rapid titration is clinically warranted, monitor closely.
Usual Adult Dose for Osteoarthritis
Initial dose: Amlodipine 5 mg-Celecoxib 200 mg orally once a day
Maximum dose: Amlodipine 10 mg-Celecoxib 200 mg orally once a day
Comments: Allow 7 to 14 days between titration. If more rapid titration is clinically warranted, monitor closely.
Usual Geriatric Dose for Hypertension
Initial dose: Amlodipine 2.5 mg-Celecoxib 200 mg orally once a day
Maximum dose: Amlodipine 10 mg-Celecoxib 200 mg orally once a day
Comments: Allow 7 to 14 days between titration. If more rapid titration is clinically warranted, monitor closely.
Usual Geriatric Dose for Osteoarthritis
Initial dose: Amlodipine 2.5 mg-Celecoxib 200 mg orally once a day
Maximum dose: Amlodipine 10 mg-Celecoxib 200 mg orally once a day
Comments: Allow 7 to 14 days between titration. If more rapid titration is clinically warranted, monitor closely.
Renal Dose Adjustments
Mild to moderate renal dysfunction: Use with caution
Severe renal dysfunction: Not recommended; if use of this drug cannot be avoided, monitor for signs of worsening renal function.
Liver Dose Adjustments
Mild liver dysfunction (Child-Pugh A): Initial dose: Amlodipine 2.5 mg-Celecoxib 200 mg orally once a day
Moderate to severe liver dysfunction (Child-Pugh B and C): Not recommended
If abnormal liver tests worsen or if clinical signs and symptoms of liver disease develop: Discontinue this drug immediately and perform a clinical evaluation of the patient.
Dose Adjustments
This drug should be used at the lowest effective dose for the shortest duration consistent with individual patient treatment goals.
Poor metabolizers of CYP450 2C9 (known or suspected): Not recommended
Small or fragile patients or those who weigh less than 50 kg: Initial dose: Amlodipine 2.5 mg-Celecoxib 200 mg orally once a day
If adding this drug to other antihypertensive therapy: Initial dose: Amlodipine 2.5 mg-Celecoxib 200 mg orally once a day
Patients already receiving both components of this drug from separate capsules and tablets: Substitute with this drug using the same component doses
Precautions
US BOXED WARNINGS:
- 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. This drug 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.
CONTRAINDICATIONS:
- Hypersensitivity (e.g., anaphylactic reactions and serious skin reactions) to either active component or any of the ingredients
- History of asthma, urticaria, or other allergic-type reactions after taking aspirin or other nonsteroidal anti-inflammatory drugs (NSAIDs)
- In the setting of coronary artery bypass graft (CABG) surgery
- Demonstrated allergic-type reactions to sulfonamides
Safety and efficacy have not been established in patients younger than 18 years.
Consult WARNINGS section for additional precautions.
Dialysis
Data not available
Other Comments
Administration advice: May be administered with or without food.
Storage requirements: Protect from light.
Monitoring:
- Cardiovascular: Blood pressure; signs of cardiac ischemia (patients with a recent myocardial infarction); worsening heart failure (patients with severe heart failure)
- Gastrointestinal: Gastrointestinal bleeding (patients also taking low-dose aspirin for cardiac prophylaxis)
- Hematologic: CBC and chemistry profile (patients on long-term nonsteroidal anti-inflammatory treatment); hemoglobin or hematocrit (patients with any signs or symptoms of anemia); bleeding (patients at increased risk of bleeding)
- Renal: Renal function (patients with renal or hepatic impairment, heart failure, dehydration, or hypovolemia)
- Respiratory: Changes in signs and symptoms of asthma (patients with preexisting asthma without known aspirin sensitivity)
Patient advice:
- Inform patients of the symptoms of serious cardiovascular events and the steps to take if they occur.
- Inform patients about the signs and symptoms of serious skin reactions.
- Advise patients to discontinue use of this drug at the first appearance of any potential sign of hypersensitivity.
- Inform patients of the warning signs and symptoms of hepatotoxicity (e.g., nausea, fatigue, lethargy, diarrhea, pruritus, jaundice, right upper quadrant tenderness, flu-like symptoms).
