Side effect of norvasc

When you have high blood pressure, you need to be very careful with over-the-counter pain medicines. Remember: No drug is risk-free. Here are some tips from the experts about using these medicines.

  • Take the safest medicine. Unless your doctor has told you it’s OK, do not use over-the-counter ibuprofen, naproxen sodium, or ketoprofen for pain relief. Instead, use a painkiller less likely to increase your blood pressure, like aspirin or acetaminophen.
  • Use as directed. Follow the directions for the recommended dosage. Most painkillers shouldn’t be used for more than 10 days. If you’re still in pain by that point, see your doctor.
  • Get your blood pressure checked regularly. This is good advice for anyone with high blood pressure. But it’s crucial if you use any of the pain relievers that can make your high blood pressure get worse.
  • Avoid alcohol. Most over-the-counter pain relievers do not mix with alcohol. If you take nonsteroidal anti-inflammatory drugs (NSAIDs), including aspirin, just one drink a week can increase your risk of gastrointestinal bleeding. People who have three or more drinks a day should not use these medicines. Combining acetaminophen and alcohol may increase the risks of liver damage.
  • Read the package insert. Admit it: When you buy a bottle of over-the-counter pain reliever, you throw out the printed insert along with the empty box. But you really should get in the habit of reading it. Find out what side effects you should look for. Look at the list of possible drug interactions.
  • Read the ingredients of all medicines. Painkillers like aspirin, acetaminophen, and ibuprofen can show up in the most unlikely places. For instance, many over-the-counter medicines for colds or even heartburn also contain doses of pain reliever. Make sure you know what you’re getting.
  • Watch out for interactions. Many drugs for common health conditions can interact with over-the counter painkillers. For instance, NSAIDs can interact with many common medicines for high blood pressure and block their effects.
    Mixing aspirin with a prescription “blood thinner” like Plavix or Coumadin can also be risky, says Nieca Goldberg, MD, a cardiologist and spokesperson for the American Heart Association. If you take prescription drugs for high blood pressure — or any other condition — ask your doctor what over-the-counter medicines you need to avoid.
  • Tell your doctor about all medicines, herbs, and supplements that you use. Interactions are a real danger. So your health care provider needs to know about all the medicines you take before you’re prescribed a new medicine. Don’t forget to mention over-the-counter medicines, herbal remedies, and vitamins.
    “Bring a list of all the medicines and supplements you take to your doctor,” says Goldberg. “It could actually save your life.”

Pain Medicines: What to do if you have heart problems or kidney disease

When people have pain, they often take pain medicines called NSAIDs (non-steroidal anti-inflammatory drugs). These include:

  • Advil and Motrin (generic and store-brand ibuprofen). Ibuprofen is also in other over-the-counter drugs, such as cold medicines.
  • Aleve (generic and store-brand naproxen).
  • Celebrex (generic celecoxib).

NSAIDs help ease pain and inflammation. But if you have high blood pressure, heart failure, or kidney disease, you should not take an NSAID. And you should not take any drugs that have ibuprofen or another NSAID in them. Here’s why:

NSAIDs are bad for your blood pressure.

NSAIDs can cause high blood pressure. And if you have high blood pressure, they can make it worse. This increases your chances of having a heart attack or a stroke.

NSAIDs can also keep some blood pressure drugs from working right. NSAIDs can interfere with:

  • Diuretics, or water pills, such as apo-Hydro (generic hydrochlorthiazide).
  • Diuretics remove excess water from the blood vessels.
  • ACE inhibitors, such as Altace and Coversyl (generic ramipril and perindopril).
  • ACE inhibitors are drugs that relax the blood vessels.
  • ARBs such as Cozaar (generic losartan). ARBs are another group of drugs that relax the blood vessels.

NSAIDs are bad for your heart and kidneys.

Long-term use of NSAIDs can make your body hold onto fluid. This can worsen the symptoms of heart failure, such as shortness of breath, swollen ankles, and a rapid or irregular heartbeat. NSAIDs can also keep the kidneys from working well. This makes taking NSAIDs risky for people who already have kidney disease.

Which painkillers can you use if you have heart or kidney disease?

There is no simple answer. The best painkiller to use depends on your health problems. It also depends on any other drugs you take. Be sure to tell your health care provider about any prescription drugs, over-the-counter drugs, or herbal medicines you take.

Over-the-counter Tylenol (generic acetaminophen) is often the best choice for people with high blood pressure, heart failure, or kidney problems.

  • However, high doses of Tylenol can damage the liver, so take the lowest dose you can to get enough pain relief.
  • Never take more than 4,000 milligrams (mg) a day. That’s equal to twelve 325 mg pills.

Managing pain without taking drugs

Non-drug treatments, such as yoga or massage, can often reduce or even replace the need for drugs. Here are some things you can try, depending on your kind of pain:

Back pain. Stay physically active. Walking is a good choice. Acupuncture, massage, physical therapy, and yoga can help reduce pain, too. And care from a chiropractor may help.

Headaches. Cut back on alcohol and avoid foods that trigger your headaches. This may help relieve pain. Exercise can help reduce stress that causes headaches. So can meditation, deep breathing, and other forms of relaxation therapy.

Osteoarthritis. Do low-impact exercise, such as walking, biking, and yoga. This can help ease pain and stiffness. Avoid high-impact activities, such as running or tennis. They can make your symptoms worse.

Fibromyalgia. Get regular exercise to help reduce pain and give you more energy. Tai chi— a form of exercise involving slow, gentle movements combined with deep breathing—is a good choice. Meditation can help with pain. So can a type of counseling called cognitive behavioral therapy.

Norvasc

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.

NORVASC has been evaluated for safety in more than 11,000 patients in U.S. and foreign clinical trials. In general, treatment with NORVASC was well-tolerated at doses up to 10 mg daily. Most adverse reactions reported during therapy with NORVASC were of mild or moderate severity. In controlled reactions reported during therapy with NORVASC were of mild or moderate severity. In controlled clinical trials directly comparing NORVASC (N=1730) at doses up to 10 mg to placebo (N=1250), discontinuation of NORVASC 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:

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

NORVASC (%)
(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:

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, asthenia,1 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.

NORVASC 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 , 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.

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

REFERENCE

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 Norvasc (Amlodipine Besylate)

How does this medication work? What will it do for me?

Amlodipine belongs to the family of medications known as calcium channel blockers. Amlodipine is used to treat high blood pressure and angina (chest pain). It works to control blood pressure and reduces the number of angina attacks by widening and relaxing blood vessels.

This medication may be available under multiple brand names and/or in several different forms. Any specific brand name of this medication may not be available in all of the forms or approved for all of the conditions discussed here. As well, some forms of this medication may not be used for all of the conditions discussed here.

Your doctor may have suggested this medication for conditions other than those listed in these drug information articles. If you have not discussed this with your doctor or are not sure why you are taking this medication, speak to your doctor. Do not stop taking this medication without consulting your doctor.

Do not give this medication to anyone else, even if they have the same symptoms as you do. It can be harmful for people to take this medication if their doctor has not prescribed it.

What form(s) does this medication come in?

2.5 mg
Each white-to-off-white emerald-shaped tablet, debossed with “NRV 2.5” on one side and “Pfizer” on the other, contains amlodipine besylate equivalent to 2.5 mg of amlodipine. Nonmedicinal ingredients: dibasic calcium phosphate anhydrous, magnesium stearate, microcrystalline cellulose, and sodium starch glycolate.

5 mg
Each white, octagonal tablet, scored, debossed with “NRV 5” on one side and “Pfizer” on the other, contains amlodipine besylate equivalent to 5 mg of amlodipine. Nonmedicinal ingredients:dibasic calcium phosphate anhydrous, magnesium stearate, microcrystalline cellulose, and sodium starch glycolate.

10 mg
Each white, octagonal tablet, debossed with “NRV 10” on one side and “Pfizer” on the other, contains amlodipine besylate equivalent to 10 mg of amlodipine. Nonmedicinal ingredients: dibasic calcium phosphate anhydrous, magnesium stearate, microcrystalline cellulose, and sodium starch glycolate.

How should I use this medication?

The recommended adult starting dose of amlodipine is 5 mg taken once daily. Depending on the effectiveness of this medication for your condition, and how well the medication is tolerated, your doctor may suggest a dose between 2.5 mg and 10 mg taken once daily.

For children ages 6 to 17 years, the recommended dose is 2.5 mg to 5 mg once daily.

Amlodipine can be taken with or without food.

Many things can affect the dose of medication that a person needs, such as body weight, other medical conditions, and other medications. If your doctor has recommended a dose different from the ones above, do not change the way that you are taking the medication without consulting your doctor.

It is important that this medication be taken exactly as prescribed by your doctor. If you miss a dose, take it as soon as possible and continue with your regular schedule. If it is less than 12 hours until your next dose, skip the missed dose and continue with your regular dosing schedule. Do not take a double dose to make up for a missed one. If you are not sure what to do after missing a dose, contact your doctor or pharmacist for advice.

Store this medication at room temperature, protect it from light, and keep it out of the reach of children.

Do not dispose of medications in wastewater (e.g. down the sink or in the toilet) or in household garbage. Ask your pharmacist how to dispose of medications that are no longer needed or have expired.

Who should NOT take this medication?

Do not take amlodipine if you:

  • are allergic to amlodipine or any ingredients of the medication
  • are allergic to other medications of the same class (e.g., felodipine, nifedipine)
  • have very low blood pressure

What side effects are possible with this medication?

Many medications can cause side effects. A side effect is an unwanted response to a medication when it is taken in normal doses. Side effects can be mild or severe, temporary or permanent.

The side effects listed below are not experienced by everyone who takes this medication. If you are concerned about side effects, discuss the risks and benefits of this medication with your doctor.

The following side effects have been reported by at least 1% of people taking this medication. Many of these side effects can be managed, and some may go away on their own over time.

Contact your doctor if you experience these side effects and they are severe or bothersome. Your pharmacist may be able to advise you on managing side effects.

  • dizziness
  • flushing
  • headache
  • nausea
  • sleepiness or unusual drowsiness
  • stomach pain
  • swelling of ankles or feet
  • unusual tiredness or weakness

Although most of the side effects listed below don’t happen very often, they could lead to serious problems if you do not seek medical attention.

Check with your doctor as soon as possible if any of the following side effects occur:

  • abnormal heartbeat (e.g., pounding heartbeat, slow heartbeat, fast heartbeat)
  • dizziness or fainting when rising from a lying or sitting position
  • increased angina symptoms (e.g., more frequent or intense chest pain)
  • signs of liver problems (e.g., nausea, vomiting, diarrhea, loss of appetite, weight loss, yellowing of the skin or whites of the eyes, dark urine, pale stools)

Stop taking the medication and seek immediate medical attention if any of the following occur:

  • symptoms of a severe allergic reaction (e.g., hives; difficulty breathing; swelling of the mouth, tongue, face, or throat)
  • symptoms of a heart attack (e.g., chest pain, pressure or heaviness; nausea; shortness of breath; cool, clammy skin; anxiety)
  • unexpected muscle stiffness, difficulty moving or unwanted movements

Some people may experience side effects other than those listed. Check with your doctor if you notice any symptom that worries you while you are taking this medication.

Are there any other precautions or warnings for this medication?

Before you begin taking a medication, be sure to inform your doctor of any medical conditions or allergies you may have, any medications you are taking, whether you are pregnant or breast-feeding, and any other significant facts about your health. These factors may affect how you should take this medication.

Chest pain/heart attack: Rarely, this medication may worsen angina (chest pain) or precipitate a heart attack when it is first started or when the dose is increased. People with severe heart disease seem to be more at risk. If you experience worsening chest pain or symptoms of a heart attack (e.g., chest pain, pressure, or heaviness; nausea; shortness of breath; cool, clammy skin; anxiety) while taking this medication, get immediate medical attention.

Grapefruit juice: Grapefruit juice may increase the effects of amlodipine. Avoid grapefruit juice while taking this medication.

Liver function: Liver disease or reduced liver function may cause this medication to build up in the body, causing side effects. If you have liver disease or decreased liver function, discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed. Your doctor may recommend a lower dose.

Low blood pressure: Like other medications for blood pressure, amlodipine may cause a lowering of blood pressure when rising from a sitting or lying position, or a racing heart rate, especially during the first few weeks of treatment. If you feel dizzy or lightheaded or feel your pulse is racing, and this feeling does not go away after a few minutes, call your doctor. If you have heart disease (e.g., heart failure, heart attack) or are taking other medications that lower blood pressure, discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed.

Pregnancy: This medication should not be used during pregnancy unless the benefits outweigh the risks. If you become pregnant while taking this medication, contact your doctor immediately.

Breast-feeding: It is not known if amlodipine passes into breast milk. If you are a breast-feeding mother and are taking this medication, it may affect your baby. Talk to your doctor about whether you should continue breast-feeding.

Children: The safety and effectiveness of amlodipine have not been established for children less than 6 years of age.

Seniors: Seniors may be more sensitive to the side effects of amlodipine. Your doctor may suggest a lower dose.

What other drugs could interact with this medication?

There may be an interaction between amlodipine and any of the following:

  • abiraterone
  • acetazolamide
  • aldesleukin
  • aliskiren
  • alpha blockers (e.g., alfuzosin, doxazosin, tamsulosin)
  • amiodarone
  • amphetamines (e.g., dextroamphetamine, lisdexamphetamine)
  • angiotensin-converting enzyme inhibitors (ACEIs; captopril, enalapril, ramipril)
  • angiotensin receptor blockers (ARBs; e.g., candasartan, irbesartan, losartan)
  • aprepitant
  • antacids
  • “azole” antifungal medications (e.g., fluconazole, itraconazole, ketoconazole)
  • barbiturates (e.g., butalbital, pentobarbital, phenobarbital)
  • beta-blockers (e.g., atenolol, metoprolol, propranolol)
  • boceprevir
  • bosentan
  • calcium supplements (e.g., calcium carbonate, calcium citrate)
  • carbamazepine
  • clopidogrel
  • conivaptan
  • cyclosporine
  • dabrafenib
  • dasatinib
  • deferasirox
  • desipramine
  • diazoxide
  • diuretics (water pills; e.g., furosemide, hydrochlorothiazide, triamterene)
  • dofetilide
  • duloxetine
  • enzalutamide
  • flecainide
  • grapefruit juice
  • guanfacine
  • haloperidol
  • hepatitis C antiviral combinations (e.g., ombitasvir – paritaprevir – ritonavir – dasabuvir, ombitasvir – paritaprevir – ritonavir)
  • HIV non-nucleoside reverse transcriptase inhibitors (NNRTIs; e.g., delavirdine, efavirenz, etravirine, nevirapine)
  • HIV protease inhibitors (e.g., atazanavir, indinavir, ritonavir)
  • hydrocodone
  • imatinib
  • imipramine
  • levodopa
  • lomitapide
  • macrolide antibiotics (e.g., clarithromycin, erythromycin)
  • melatonin
  • methylphenidate
  • mifepristone
  • minoxidil
  • modafinil
  • nefazodone
  • nitrates (e.g., nitroglycerin, isosorbide dinitrate, isosorbide mononitrate)
  • obinutuzumab
  • other calcium channel blockers (e.g., diltiazem, nifedipine, verapamil)
  • pentoxifylline
  • phenytoin
  • phosphodiesterase-5 inhibitors (e.g., sildenafil, tadalafil, vardenafil)
  • pimozide
  • primidone
  • quinidine
  • rifabutin
  • rifampin
  • rituximab
  • St. John’s wort
  • second-generation antipsychotics (e.g., clozapine, olanzapine, quetiapine, risperidone)
  • simeprevir
  • simvastatin
  • stiripentol
  • tacrolimus
  • theophylline
  • tizanidine
  • tocilizumab
  • yohimbine

If you are taking any of these medications, speak with your doctor or pharmacist. Depending on your specific circumstances, your doctor may want you to:

  • stop taking one of the medications,
  • change one of the medications to another,
  • change how you are taking one or both of the medications, or
  • leave everything as is.

An interaction between two medications does not always mean that you must stop taking one of them. Speak to your doctor about how any drug interactions are being managed or should be managed.

Medications other than those listed above may interact with this medication. Tell your doctor or prescriber about all prescription, over-the-counter (non-prescription), and herbal medications you are taking. Also tell them about any supplements you take. Since caffeine, alcohol, the nicotine from cigarettes, or street drugs can affect the action of many medications, you should let your prescriber know if you use them.

All material copyright MediResource Inc. 1996 – 2020. Terms and conditions of use. The contents herein are for informational purposes only. Always seek the advice of your physician or other qualified health provider with any questions you may have regarding a medical condition. Source: www.medbroadcast.com/drug/getdrug/Norvasc

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