Amlodipine and celecoxib (Oral route)

Pronunciation:

am-LOE-di-peen, sel-e-KOX-ib

Brand Names:

Consensi

Dosage Forms:

Tablet

Warnings:

Oral route(Tablet)

NSAIDs cause an increased risk of serious cardiovascular thrombotic events, including myocardial infarction, and stroke, which can be fatal. This risk may occur early in the treatment and may increase with duration of use. Amlodipine/celecoxib is contraindicated in the setting of CABG surgery. 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 .

Classifications:

Therapeutic—

Antihypertensive

Pharmacologic—

Calcium Channel Blocker

Chemical—

Dihydropyridine

Uses of This Medicine:

Amlodipine and celecoxib combination is used to treat high blood pressure (hypertension) and help relieve the symptoms of osteoarthritis (eg, swelling, stiffness, and joint pain).

Amlodipine is a calcium channel blocker (CCB). It affects the movement of calcium into the cells of the heart and blood vessels. This relaxes the blood vessels and lowers blood pressure, which will increase the supply of blood and oxygen to the heart. Lowering blood pressure can reduce the risk of strokes and heart attacks.

Celecoxib is a nonsteroidal anti-inflammatory drug (NSAID). It does not cure osteoarthritis and will help you only as long as you continue to use it.

This medicine is available only with your doctor's prescription.

Before Using This Medicine:

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies—

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Children—

Appropriate studies have not been performed on the relationship of age to the effects of amlodipine and celecoxib combination in the pediatric population. Safety and efficacy have not been established.

Older adults—

Appropriate studies have not been performed on the relationship of age to the effects of amlodipine and celecoxib combination in the elderly. However, elderly patients are more likely to have age-related liver, kidney, heart, or stomach problems, which may require caution and an adjustment in the dose for patients receiving amlodipine and celecoxib combination.

Breast-feeding—

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Other medicines—

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.

Ketorolac

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

Abametapir
Abciximab
Aceclofenac
Acemetacin
Acenocoumarol
Adagrasib
Amiloride
Amineptine
Amitriptyline
Amitriptylinoxide
Amoxapine
Amtolmetin Guacil
Anagrelide
Apixaban
Ardeparin
Argatroban
Asciminib
Aspirin
Atazanavir
Balsalazide
Bemetizide
Bemiparin
Bendroflumethiazide
Benzthiazide
Betamethasone
Betrixaban
Bismuth Subsalicylate
Bivalirudin
Bromfenac
Budesonide
Bufexamac
Bumetanide
Cangrelor
Capecitabine
Ceritinib
Certoparin
Chlorothiazide
Chlorthalidone
Choline Magnesium Trisalicylate
Choline Salicylate
Cilostazol
Citalopram
Clarithromycin
Clomipramine
Clonixin
Clopamide
Clopidogrel
Conivaptan
Cortisone
Cyclopenthiazide
Cyclosporine
Cyclothiazide
Dabigatran Etexilate
Dabrafenib
Dalteparin
Danaparoid
Dantrolene
Darunavir
Deflazacort
Desipramine
Desirudin
Desmopressin
Desvenlafaxine
Dexamethasone
Dexibuprofen
Dexketoprofen
Diazoxide
Dibenzepin
Diflunisal
Digoxin
Dipyridamole
Dipyrone
Domperidone
Dothiepin
Doxepin
Droperidol
Droxicam
Duloxetine
Edoxaban
Emtricitabine
Enoxaparin
Epirubicin
Eplerenone
Epoprostenol
Eptifibatide
Escitalopram
Ethacrynic Acid
Etodolac
Etofenamate
Etoricoxib
Etozolin
Fedratinib
Felbinac
Fenoprofen
Fepradinol
Feprazone
Feverfew
Fexinidazole
Floctafenine
Fluconazole
Flufenamic Acid
Fluocortolone
Fluoxetine
Flurbiprofen
Fluvoxamine
Fondaparinux
Fosnetupitant
Furosemide
Ginkgo
Gossypol
Heparin
Hydrochlorothiazide
Hydrocortisone
Hydroflumethiazide
Ibuprofen
Iloprost
Imipramine
Indapamide
Inotersen
Itraconazole
Ivosidenib
Ketoprofen
Lacosamide
Lepirudin
Levomilnacipran
Lithium
Lofepramine
Lornoxicam
Loxoprofen
Lumiracoxib
Magnesium Salicylate
Mavacamten
Meadowsweet
Meclofenamate
Mefenamic Acid
Melitracen
Meloxicam
Melphalan
Mesalamine
Methotrexate
Methyclothiazide
Methylprednisolone
Metolazone
Milnacipran
Morniflumate
Nabumetone
Nadroparin
Naproxen
Nefazodone
Nepafenac
Netupitant
Niflumic Acid
Nimesulide
Nimesulide Beta Cyclodextrin
Nitisinone
Nortriptyline
Olsalazine
Omaveloxolone
Opipramol
Oxaprozin
Oxyphenbutazone
Paramethasone
Parecoxib
Parnaparin
Paroxetine
Pemetrexed
Pentosan Polysulfate Sodium
Pentoxifylline
Phenindione
Phenobarbital
Phenprocoumon
Phenylbutazone
Phenyl Salicylate
Piketoprofen
Piperaquine
Piretanide
Piroxicam
Polythiazide
Potassium Citrate
Prasugrel
Prednisolone
Prednisone
Primidone
Proglumetacin
Propyphenazone
Proquazone
Protein C
Protriptyline
Quinethazone
Reviparin
Rifampin
Ritonavir
Rivaroxaban
Rofecoxib
Salicylamide
Salicylic Acid
Salsalate
Selexipag
Sertraline
Sibutramine
Simvastatin
Sodium Salicylate
Sparsentan
Spironolactone
Sulfasalazine
Sulfinpyrazone
Sulindac
Sulodexide
Tacrolimus
Tegafur
Telaprevir
Tenofovir Alafenamide
Tenofovir Disoproxil Fumarate
Tenoxicam
Tianeptine
Tiaprofenic Acid
Ticagrelor
Ticlopidine
Tinzaparin
Tirofiban
Tocilizumab
Tolfenamic Acid
Tolmetin
Torsemide
Trazodone
Treprostinil
Triamterene
Trichlormethiazide
Trimipramine
Trolamine Salicylate
Valdecoxib
Venlafaxine
Vilazodone
Vorapaxar
Vortioxetine
Warfarin
Xipamide

Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

Acebutolol
Aprepitant
Atenolol
Azilsartan
Azilsartan Medoxomil
Benazepril
Betaxolol
Bisoprolol
Boceprevir
Candesartan
Captopril
Carteolol
Carvedilol
Celiprolol
Ciprofloxacin
Cobicistat
Crizotinib
Diltiazem
Dronedarone
Enalapril
Enalaprilat
Eprosartan
Esmolol
Fluconazole
Fluvoxamine
Fosinopril
Idelalisib
Indinavir
Irbesartan
Ketoconazole
Labetalol
Letermovir
Levobunolol
Lisinopril
Lopinavir
Losartan
Metipranolol
Metoprolol
Moexipril
Nadolol
Nebivolol
Nefazodone
Nelfinavir
Nilotinib
Olmesartan
Oxprenolol
Penbutolol
Perindopril
Pindolol
Posaconazole
Propranolol
Quinapril
Ramipril
Rifapentine
Saquinavir
Sotalol
Spirapril
Telithromycin
Telmisartan
Timolol
Trandolapril
Valsartan
Verapamil
Voriconazole

Other interactions—

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other medical problems—

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

Aortic stenosis (heart valve problem), severe or
Blood clotting disorder or
Heart disease, severe or
Heart failure, severe, history of—Use with caution. May cause side effects to become worse.

Aspirin-sensitive asthma or
Aspirin sensitivity, history of or
Kidney disease, severe or
Liver disease, moderate to severe or
Sulfa or sulfonamide allergy—Should not be used in patients with these conditions.

Coagulopathy (bleeding disorder) or
Kidney disease, advanced—May increase risk of stomach or bowel bleeding.

Dehydration or
Hypovolemia—Must be corrected first before using this medicine.

Heart attack, recent or
Stomach or bowel problems (eg, peptic ulcer disease, bleeding), history of—Use with caution. Make make these conditions worse.

Heart surgery (eg, coronary artery bypass graft [CABG])—Should not be used to relieve pain right before or after the surgery.

Proper Use of This Medicine:

For safe and effective use of this medicine, do not take more of it, do not take it more often, and do not take it for a longer time than your doctor ordered. Taking too much of this medicine may increase the chance of unwanted effects.

In addition to the use of this medicine, treatment for your high blood pressure may include weight control and changes in the types of foods you eat, especially foods high in sodium (salt). Your doctor will tell you which of these are most important for you. You should check with your doctor before changing your diet.

Remember that this medicine will not cure your high blood pressure, but it does help control it. Therefore, you must continue to take it as directed if you expect to lower your blood pressure and keep it down. You might have to take high blood pressure medicine for the rest of your life. If high blood pressure is not treated, it can cause serious problems such as heart failure, blood vessel disease, strokes, or kidney disease.

This medicine comes with a Medication Guide. Read and follow these instructions carefully. Ask your doctor if you have any questions.

Dosing—

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

For oral dosage form (tablets):
- For hypertension and osteoarthritis:
  - Adults—At first, amlodipine 5 milligrams (mg) and celecoxib 200 mg once a day. Your doctor may adjust your dose as needed. However, the dose is usually not more than amlodipine 10 mg and celecoxib 200 mg per day.
  - Children—Use and dose must be determined by your doctor.

Missed dose—

If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage—

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Precautions While Using This Medicine:

It is very important that your doctor check your progress at regular visits to make sure this medicine is working properly. Blood and urine tests may be needed to check for unwanted effects.

Do not stop using this medicine without asking your doctor, even if the pain stops and you feel well. Wait until your doctor prescribes a different medicine to treat your blood pressure.

Using this medicine during the later part of pregnancy can harm your unborn baby. If you think you have become pregnant while using the medicine, tell your doctor right away.

This medicine may increase your risk of having a heart attack or stroke. This is more likely in people who already have heart disease or in people who use this medicine for a longer time.

This medicine may cause bleeding in your stomach or intestines. This problem can happen without warning signs. This is more likely if you have had a stomach ulcer in the past, if you smoke or drink alcohol regularly, if you are over 60 years of age, are in poor health, or are using certain other medicines (such as a steroid or a blood thinner).

Check with your doctor right away if you have pain or tenderness in the upper stomach, pale stools, dark urine, loss of appetite, nausea, vomiting, or yellow eyes or skin. These could be symptoms of a serious liver problem.

Possible warning signs of some serious side effects that can occur during treatment with this medicine may include swelling of the face, fingers, feet, or lower legs, severe stomach pain, black, tarry stools, or vomiting of blood or material that looks like coffee grounds, unusual weight gain, yellow skin or eyes, decreased urination, unusual bleeding or bruising, or skin rash. Also, signs of serious heart problems could occur including chest pain or tightness, fast or irregular heartbeat, unusual flushing or warmth of the skin, weakness, or slurring of speech. Check with your doctor immediately if you notice any of these warning signs.

Check with your doctor right away if you have bloody urine, a decrease in frequency or amount of urine, an increase in blood pressure, increased thirst, loss of appetite, lower back or side pain, nausea, swelling of the face, fingers, or lower legs, trouble breathing, unusual tiredness or weakness, vomiting, or weight gain. These could be symptoms of a serious kidney problem.

Hyperkalemia (high potassium in the blood) may occur while you are using this medicine. Check with your doctor right away if you have the following symptoms: stomach pain, confusion, difficulty with breathing, irregular heartbeat, nausea or vomiting, nervousness, numbness or tingling in the hands, feet, or lips, or weakness or heaviness of the legs.

This medicine may cause a serious allergic reaction called anaphylaxis, which can be life-threatening and requires immediate medical attention. Call your doctor right away if you have a rash, itching, trouble breathing or swallowing, or any swelling of your hands, face, or mouth while you are using this medicine.

Serious skin reactions, including Stevens-Johnson syndrome, toxic epidermal necrolysis, drug reaction with eosinophilia and systemic symptoms (DRESS), and acute generalized exanthematous pustulosis (AGEP) can occur during treatment with this medicine. Check with your doctor right away if you have black, tarry stools, blistering, peeling, or loosening of the skin, chest pain, chills, cough, diarrhea, fever, itching, joint or muscle pain, painful or difficult urination, red irritated eyes, red skin lesions, sore throat, sores, ulcers, or white spots in the mouth or on the lips, swollen glands, unusual bleeding or bruising, or unusual tiredness or weakness.

This medicine may cause a delay in ovulation for women and may affect their ability to have children. If you plan to have children, talk with your doctor before using this medicine.

Before having any kind of surgery or medical tests, tell your doctor that you are using this medicine. It may be necessary for you to stop treatment for a while, or to change to a different NSAID before your procedure.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

Side Effects of This Medicine:

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

Less common: Arm, back, or jaw pain; black, tarry stools; bleeding gums; blood in the urine or stools; blurred vision; chest pain, discomfort, tightness, or heaviness; cloudy urine; cough; cough producing mucus; cracked, dry, scaly skin; diarrhea; difficult, burning, or painful urination; difficulty in swallowing; dizziness; fainting; fast or irregular breathing; fast, irregular, pounding, or racing heartbeat or pulse; fever; frequent urge to urinate; headache, severe and throbbing; heartburn; increased sensitivity of the skin to sunlight; itching, skin rash; joint or muscle pain or stiffness; loss of appetite; loss of consciousness; nausea; nervousness; noisy breathing; nosebleed; pain in the lower back; pain or burning in the throat; pain or discomfort in the arms, jaw, back, or neck; pale skin; pinpoint red spots on the skin; pounding in the ears; redness or other discoloration of the skin; severe sunburn; slow heartbeat; sneezing; sore throat; sores, ulcers, or white spots on the lips or tongue or inside the mouth; stomach pain or tenderness; sudden decrease in the amount of urine; swelling of the eyes, eyelids, face, arms, or legs; swelling, tenderness, warmth, blistering, crusting, irritation, itching, or reddening of the skin; trouble breathing; unusual bleeding or bruising; unusual tiredness or weakness; vomiting

Rare: Anxiety; bloody nose; bloating; changes in skin color, pain, tenderness, or swelling of the foot or leg; chills; cold, pale or a bluish skin color of the fingers or toes; confusion; constipation; darkened urine; decreased frequency or amount of urine; dilated neck veins; dry mouth; flushed, dry skin; fruit-like breath odor; gaseous stomach pain; increased blood pressure; increased hunger; increased thirst; increased urination; indigestion; irregular breathing; large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or genitals; numbness and tingling of the face, fingers, or toes; pain in the arms, legs, or lower back, especially in the calves or heels upon exertion; pale, bluish-colored, or cold hands or feet; rapid, shallow breathing; recurrent fever; severe constipation; severe stomach pain, cramping, or burning; sores, welts, or blisters; stomach fullness; swollen glands; unexplained weight loss; vomiting of blood or material that looks like coffee grounds, severe and continuing; weak or absent pulses in the legs; weight gain; yellow eyes or skin

Incidence not known: Clay-colored stools; cold sweats; muscle pain or cramps; nightmares; seizures; shakiness; slurred speech; stiff neck or back; unpleasant breath odor; upper right abdominal or stomach pain

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common: Belching; body aches or pain; ear congestion; loss of voice; runny or stuffy nose

Less common: Bleeding after defecation; burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings; continuing ringing or buzzing or other unexplained noise in the ears; difficulty in moving; dryness of the throat; excess air or gas in the stomach or bowels; feeling of constant movement of self or surroundings; frequent urge to defecate; full feeling; hearing loss; hoarseness; leg cramps; loss or thinning of the hair; pain or tenderness around the eyes and cheekbones; passing gas; sensation of spinning; straining while passing stool; stuffy nose; swelling or inflammation of the mouth; trouble sleeping; uncomfortable swelling around the anus; voice changes

Rare: Abnormal ejaculation; burning, dry, or itching eyes; decreased sexual performance or desire; discharge, excessive tearing; double vision; eye pain; feeling unusually cold; lack or loss of strength; redness, pain, swelling of the eye, eyelid, or inner lining of the eyelid; seeing double; shivering; unsteadiness, trembling, or other problems with muscle control or coordination; unsteady walk

Incidence not known: Loss of sense of smell or taste; swelling of the breasts or breast soreness in both females and males

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

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

Last Updated: 11/16/2023

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