Free Swaziland: Vimovo

Generic Name: naproxen and esomeprazole (Oral route)

na-PROX-en, es-oh-MEP-ra-zole mag-NEE-zee-um

Oral route(Tablet, Delayed Release)

Esomeprazole magnesium/naproxen may cause an increased risk of serious cardiovascular thrombotic events, myocardial infarction, and stroke, which can be fatal. This risk may be increased in patients with cardiovascular disease or risk factors for cardiovascular disease. Naproxen is contraindicated for the treatment of perioperative pain in the setting of CABG surgery. Esomeprazole magnesium/naproxen contains an NSAID. NSAID-containing products can also cause an increased risk of serious gastrointestinal adverse events especially in the elderly, including bleeding, ulceration, and perforation of the stomach or intestines, which can be fatal .

Commonly used brand name(s)

In the U.S.

Vimovo

Available Dosage Forms:

Tablet, Delayed Release

Therapeutic Class: Antirheumatic

Pharmacologic Class: NSAID

Chemical Class: Propionic Acid (class)

Uses For Vimovo

Naproxen and esomeprazole combination is used to relieve the symptoms of ankylosing spondylitis, osteoarthritis, and rheumatoid arthritis. It is used for patients who have an increased risk for stomach ulcers and who need to take a nonsteroidal anti-inflammatory drug (NSAID) for arthritis or ankylosing spondylitis.

Naproxen is a nonsteroidal anti-inflammatory drug (NSAID) that is used to treat pain, inflammation, swelling, stiffness, and joint pain. Esomeprazole is a proton pump inhibitor (PPI) that is used to treat certain conditions where too much acid is produced in the stomach (e.g., duodenal and gastric ulcers).

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

Before Using Vimovo

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.

Pediatric

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

Geriatric

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of naproxen and esomeprazole combination in the elderly. However, elderly patients are more likely to have age-related kidney problems, which may require caution and an adjustment in the dose for patients receiving this medicine.

Pregnancy

	Pregnancy Category	Explanation
1st Trimester	C	Animal studies have shown an adverse effect and there are no adequate studies in pregnant women OR no animal studies have been conducted and there are no adequate studies in pregnant women.
2nd Trimester	C	Animal studies have shown an adverse effect and there are no adequate studies in pregnant women OR no animal studies have been conducted and there are no adequate studies in pregnant women.
3rd Trimester	D	Studies in pregnant women have demonstrated a risk to the fetus. However, the benefits of therapy in a life threatening situation or a serious disease, may outweigh the potential risk.

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.

Interactions with 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

Pentoxifylline

Rilpivirine

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.

Abciximab

Ardeparin

Argatroban

Aspirin

Atazanavir

Beclamide

Beta Glucan

Bivalirudin

Caramiphen

Carbamazepine

Certoparin

Chlormethiazole

Cilostazol

Citalopram

Clopidogrel

Clovoxamine

Dabigatran Etexilate

Dalteparin

Danaparoid

Dasatinib

Desirudin

Diazepam

Dipyridamole

Enoxaparin

Erlotinib

Escitalopram

Ethotoin

Felbamate

Femoxetine

Flesinoxan

Fluoxetine

Fluvoxamine

Fondaparinux

Fosphenytoin

Gabapentin

Ginkgo

Heparin

Lacosamide

Lepirudin

Mephenytoin

Mephobarbital

Methotrexate

Mycophenolate Mofetil

Nadroparin

Nefazodone

Nelfinavir

Nilotinib

Oxcarbazepine

Paraldehyde

Paramethadione

Parnaparin

Paroxetine

Pemetrexed

Phenacemide

Phenobarbital

Phenytoin

Piracetam

Pregabalin

Protein C

Reviparin

Rivaroxaban

Rufinamide

Sertraline

Sibutramine

Stiripentol

Tacrolimus

Tiagabine

Ticlopidine

Tinzaparin

Tirofiban

Topiramate

Trimethadione

Valproic Acid

Vigabatrin

Vilazodone

Warfarin

Zimeldine

Zonisamide

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

Acetohexamide

Alacepril

Alprenolol

Amiloride

Arotinolol

Atenolol

Azilsartan Medoxomil

Azosemide

Befunolol

Bemetizide

Benazepril

Bendroflumethiazide

Benzthiazide

Betaxolol

Bevantolol

Bisoprolol

Bopindolol

Bucindolol

Bumetanide

Bupranolol

Buthiazide

Candesartan Cilexetil

Canrenoate

Captopril

Carteolol

Carvedilol

Celiprolol

Chlorothiazide

Chlorpropamide

Chlorthalidone

Cilazapril

Clopamide

Cranberry

Cyclopenthiazide

Cyclosporine

Delapril

Desvenlafaxine

Dilevalol

Duloxetine

Enalaprilat

Enalapril Maleate

Eprosartan

Esmolol

Ethacrynic Acid

Fosinopril

Furosemide

Gliclazide

Glimepiride

Glipizide

Gliquidone

Glyburide

Hydrochlorothiazide

Hydroflumethiazide

Imidapril

Indapamide

Irbesartan

Labetalol

Landiolol

Levobetaxolol

Levobunolol

Lisinopril

Lithium

Losartan

Mepindolol

Methyclothiazide

Metipranolol

Metolazone

Metoprolol

Milnacipran

Moexipril

Nadolol

Nebivolol

Nipradilol

Olmesartan Medoxomil

Oxprenolol

Penbutolol

Pentopril

Perindopril

Pindolol

Piretanide

Polythiazide

Posaconazole

Propranolol

Quinapril

Ramipril

Sotalol

Spirapril

Spironolactone

Talinolol

Tasosartan

Telmisartan

Temocapril

Tertatolol

Timolol

Tolazamide

Tolbutamide

Torsemide

Trandolapril

Triamterene

Trichlormethiazide

Valsartan

Venlafaxine

Warfarin

Xipamide

Zofenopril

Interactions with Food/Tobacco/Alcohol

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.

Proper Use of Vimovo

Use this medicine exactly as ordered by your doctor. Do not take more of it, do not take it more often, and do not take it for a longer time than ordered by your doctor. Taking too much of this medicine may increase the chance of unwanted effects, especially in elderly patients.

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

It is best to take this medicine on an empty stomach about 30 minutes before a meal.

Swallow the delayed-release tablet whole with water. Do not break, crush, chew, or dissolve it.

Your doctor may tell you to take vitamin D and calcium supplements while you are using this medicine.

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 (delayed-release tablets):
- For rheumatoid arthritis, osteoarthritis, and ankylosing spondylitis:
  - Adults—One tablet two times 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 Vimovo

It is very important that your doctor check your progress at regular visits while you are taking this medicine. This will allow your doctor to see if the medicine is working properly and to decide if you should continue to take it. Blood and urine tests may be needed to check for unwanted effects.

Naproxen may increase your risk of having a heart attack or stroke. This is more likely in people who already have heart disease. People who use this medicine for a long time might also have a higher risk.

Naproxen 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 steroids or a blood thinner).

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

Serious skin reactions can occur with this medicine. Check with your doctor right away if you have any of the following symptoms while using this medicine: blistering, peeling, or loosening of the skin; chills; cough; diarrhea; fever; itching; joint or muscle pain; red skin lesions; sore throat; sores, ulcers, or white spots in the mouth or on the lips; or unusual tiredness or weakness.

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

Check with your doctor right away if you have any symptoms of liver problems including dark-colored urine or pale stools, nausea, vomiting, loss of appetite, pain in your upper stomach, or yellowing of your skin or eyes.

This medicine may cause hypomagnesemia (low magnesium in the blood). Your doctor may want to check your blood levels if you are taking this medicine for more than one year, or if you are taking this medicine together with digoxin (Lanoxin®) or certain diuretics or "water pills". Stop using this medicine and check with your doctor right away if you have convulsions (seizures); fast, racing, or uneven heartbeat; muscle spasms (tetany); tremors; or unusual tiredness or weakness.

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 the medicine for a while, or to change to a different medicine 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.

Vimovo Side Effects

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:

More common

Burning feeling in the chest or stomach

indigestion

loss of appetite

nausea

stomach bloating, cramping, or pain

tenderness in the stomach area

upper abdominal or stomach pain

upset stomach

vomiting

weight loss

Less common

Abdominal or stomach discomfort

black, tarry stools

bladder pain

bloating or swelling of the face, arms, hands, lower legs, or feet

bloody or cloudy urine

bloody stools

chest pain

difficult, burning, or painful urination

difficulty with moving

difficulty with swallowing

frequent urge to urinate

full or bloated feeling

heartburn

lower back or side pain

muscle pain or stiffness

pain in the joints

pain or burning in the throat

pressure in the stomach

rapid weight gain

sores, ulcers, or white spots on the lips or tongue or inside the mouth

swelling of the abdominal or stomach area

tingling of the hands or feet

unusual weight gain or loss

vomiting of blood or material that looks like coffee grounds

Incidence not known

Drowsiness

mood or mental changes

muscle spasms (tetany) or twitching seizures

trembling

unusual tiredness or weakness

vomiting

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

Acid or sour stomach

belching

diarrhea

Less common

Body aches or pain

change in taste

chills

cough

cough producing mucus

difficulty having a bowel movement (stool)

difficulty with breathing

ear congestion

excess air or gas in the stomach or intestines

fever

headache

loss of taste

loss of voice

nasal congestion

pain or tenderness around the eyes and cheekbones

passing gas

shortness of breath or troubled breathing

sneezing

sore throat

stuffy or runny nose

tightness of the chest or wheezing

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.

See also: Vimovo side effects (in more detail)

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More Vimovo resources

Vimovo Side Effects (in more detail)
Vimovo Use in Pregnancy & Breastfeeding
Vimovo Drug Interactions
Vimovo Support Group
6 Reviews for Vimovo - Add your own review/rating

Vimovo Prescribing Information (FDA)

Vimovo Delayed-Release Tablets MedFacts Consumer Leaflet (Wolters Kluwer)

Vimovo Consumer Overview

Compare Vimovo with other medications

Ankylosing Spondylitis
NSAID-Induced Ulcer Prophylaxis
Osteoarthritis
Rheumatoid Arthritis

Free Swaziland

Wednesday, October 19, 2016

Vimovo