Norvasc -proven Treatment For High Blood Pressure
NORVASC (amlodipine besylate) is the most prescribed brand name high blood pressure medicine worldwide
.
NORVASC is available in 88 countries. It has been tested in more than 700 medical studies. And it has a proven safety record. Ask your doctor if NORVASC is right for you.
NORVASC Safety Information:
NORVASC is indicated for high blood pressure and angina. In clinical trials, the most common side effects for
NORVASC versus placebo were edema (8.3% vs 2.4%), headache (7.3% vs 7.8%), fatigue (4.5% vs 2.8%),
and dizziness (3.2% vs 3.4%).
Caduet Safety Information:
Caduet is a prescription drug that combines two medicines, NORVASC (amlodipine besylate) and Lipitor
(atorvastatin calcium). NORVASC is used to treat high blood pressure (hypertension), chest pain (angina), or
blocked arteries of the heart (coronary artery disease); Lipitor is used along with diet and exercise to lower
high cholesterol. It is also used to lower the risk of heart attack and stroke in people with multiple risk factors
for heart disease - such as family history, high blood pressure, age, low HDL-C, or smoking.
Lipitor is also used in patients with type 2 diabetes and at least one other risk factor for heart disease such as
high blood pressure, smoking or complications of diabetes, including eye disease and protein in urine, to
reduce the risk of heart attack and stroke.
Caduet is not for everyone. It is not for those with liver problems. And it is not for women who are nursing, are
pregnant, or may become pregnant. If you take Caduet, tell your doctor if you feel any new muscle pain or
weakness. This could be a sign of rare but serious muscle side effects. Tell your doctor about all of the
medicines you take. This may help avoid serious drug interactions. Your doctor should do blood tests to check
your liver function before and during treatment and may adjust your dose. If you have any heart problems, be
sure to tell your doctor. The most common side effects are edema, headache and dizziness. They tend to be
mild and often go away.
Caduet is one of many options for treating high blood pressure and high cholesterol, in addition to diet
and exercise, that you and your doctor can consider.
HIGHLIGHTS OF PRESCRIBING INFORMATION
These highlights do not include all the information needed to use
NORVASC safely and effectively. See full prescribing information for
NORVASC.
NORVASC (amlodipine besylate) Tablets for oral administration
Initial U.S. Approval: 1987
---------------------------INDICATIONS AND USAGE---------------------------
NORVASC is a calcium channel blocker and may be used alone or in
combination with other antihypertensive and antianginal agents for the
treatment of:
Hypertension
Coronary Artery Disease o Chronic Stable Angina
o Vasospastic Angina (Prinzmetals or Variant Angina)
o Angiographically Documented Coronary Artery
Disease in patients without heart failure or an ejection
fraction < 40%
----------------------DOSAGE AND ADMINISTRATION-----------------------
Adult recommended starting dose: 5 mg once daily with maximum dose
10 mg once daily.
Small, fragile, or elderly patients, or patients with hepatic
insufficiency may be started on 2.5 mg once daily.
Pediatric starting dose: 2.5 mg to 5 mg once daily.
Important Limitation: Doses in excess of 5 mg daily have not been studied
in pediatric patients
---------------------DOSAGE FORMS AND STRENGTHS----------------------
2.5 mg, 5 mg, and 10 mg Tablets
-------------------------------CONTRAINDICATIONS------------------------------
Known sensitivity to amlodipine
-----------------------WARNINGS AND PRECAUTIONS------------------------
Symptomatic hypotension is possible, particularly in patients with severe
aortic stenosis. However, because of the gradual onset of action, acute
hypotension is unlikely
Worsening angina and acute myocardial infarction can develop after
starting or increasing the dose of NORVASC, particularly in patients
with severe obstructive coronary artery disease.
Titrate slowly when administering calcium channel blockers to patients
with severe hepatic impairment.
------------------------------ADVERSE REACTIONS-------------------------------
Most common adverse reactions are headache and edema which occurred in a
Dose related manner. Other adverse experiences not dose related but reported
with an incidence >1.0% are headache, fatigue, nausea, abdominal pain, and
somnolence.
To report SUSPECTED ADVERSE REACTIONS, contact Pfizer at 1-
800-438-1985 or www.pfizer.com or FDA at 1-800-FDA-1088 or
www.fda.gov/medwatch.
-----------------------USE IN SPECIFIC POPULATIONS------------------------
Pregnancy: Use only if the potential benefit justifies the potential risk.
Nursing: Discontinue when administering NORVASC
.
Pediatric: Effect on patients less than 6 years old is not known
Geriatric: Start dosing at the low end of the dose range, due to the
greater frequency of decreased hepatic, renal, or cardiac function and of
concomitant disease or other drug therapy.
Revised: March 2010
______________________________________________________________________________________________________________________________________
FULL PRESCRIBING INFORMATION: CONTENTS*
1 INDICATIONS AND USAGE
1.1 Hypertension
1.2 Coronary Artery Disease (CAD)
2 DOSAGE AND ADMINISTRATION
2.1 Adults
2.2 Children
3 DOSAGE FORMS AND STRENGTHS
4 CONTRAINDICATIONS
5 WARNINGS AND PRECAUTIONS
5.1 Hypotension
5.2 Increased Angina or Myocardial Infarction
5.3 Beta-Blocker Withdrawal
5.4 Patients with Hepatic Failure
6 ADVERSE REACTIONS
6.1 Clinical Trials Experience
6.2 Postmarketing Experience
7 DRUG INTERACTIONS
7.1 In Vitro Data
7.2 Cimetidine
7.3 Grapefruit Juice
7.4 Magnesium and Aluminum Hydroxide Antacid
7.5 Sildenafil
7.6 Atorvastatin
7.7 Digoxin
7.8 Ethanol (Alcohol)
7.9 Warfarin
7.10 CYP3A4 Inhibitors
7.11 CYP3A4 Inducers
7.12 Drug/Laboratory Test Interactions
8 USE IN SPECIFIC POPULATIONS
8.1 Pregnancy
8.3 Nursing Mothers
8.4 Pediatric Use
8.5 Geriatric Use
10 OVERDOSAGE
11 DESCRIPTION
12 CLINICAL PHARMACOLOGY
12.1 Mechanism of Action
12.2 Pharmacodynamics
12.3 Pharmacokinetics and Metabolism
12.4 Pediatric Patients
13 NONCLINICAL TOXICOLOGY
13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility
14 CLINICAL STUDIES
14.1 Effects in Hypertension
14.2 Effects in Chronic Stable Angina
14.3 Effects in Vasospastic Angina
14.4 Effects in Documented Coronary Artery Disease
14.5 Studies in Patients with Heart Failure
16 HOW SUPPLIED/STORAGE AND HANDLING
16.1 2.5 mg Tablets
16.2 5 mg Tablets
16.3 10 mg Tablets
16.4 Storage
* Sections or subsections omitted from the full prescribing information are not
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