Amlodipine

Blood pressure and headache frequency were evaluated in normotensive male and female cocaine-dependent patients (N=43) participating in a placebo-controlled, double-blind trial of amlodipine for the treatment of cocaine dependence. Amlodipine produced a significant reduction in both systolic (p=0.04) and diastolic (p=0.01) blood pressures without producing dizziness or faintness. Placebo subjects had about three times the frequency of headaches compared to the amlodipine-treated subjects (p=0.004). The high frequency of headaches reported by cocaine-dependent individuals was significantly reduced by amlodipine and may reflect improved cerebrovascular tone.

Am J Cardiol 2003 Feb 1;91(3):274-9.
Comparison of effects of nisoldipine-extended release and amlodipine in patients with systemic hypertension and chronic stable angina pectoris
Pepine CJ, Cooper-DeHoff RM, Weiss RJ, Koren M, Bittar N, Thadani U, Minkwitz MC, Michelson EL, Hutchinson HG; Comparative Efficacy and Safety of Nisoldipine and Amlodipine (CESNA-II) Study Investigators
University of Florida College of Medicine, Gainesville, Florida 32610, USA.

The efficacy and safety of nisoldipine-extended release (ER) and amlodipine were compared in a 6-week multicenter, randomized, double-blind, double-dummy, parallel group, titration-to-effect trial in patients with stage 1 to 2 systemic hypertension (90 to 109 mm Hg diastolic blood pressure [BP]) and chronic stable angina pectoris. After a 3-week placebo run-in period, patients (n = 120) were randomly assigned to active treatment with either nisoldipine-ER (20 to 40 mg) or amlodipine (5 to 10 mg) once daily, titrated as necessary after 2 weeks to achieve diastolic BP <90 mm Hg. After 6 weeks, the mean reduction in systolic/diastolic BP from baseline was 15/13 mm Hg with nisoldipine-ER and 13/11 mm Hg with amlodipine (p = NS/p = NS). Both drugs resulted in similar BP responder rates (diastolic BP <90 mm Hg in 87% of patients who received nisoldipine-ER and 78% of patients on amlodipine, p = NS) and anti-ischemic responder rates (increasing exercise time >20% in 20% and 27%, respectively [p = NS], and increasing exercise time >60 seconds in 32% and 29% of patients, respectively [p = NS]. Also, after 6 weeks of active therapy, there was a similar mean increase in total exercise duration (23 seconds in the nisoldipine-ER group and 21 seconds in the amlodipine group, p = NS). Neither drug increased heart rate and both decreased frequency of anginal episodes. Adverse events were infrequent, and typically were vasodilator-related effects (including headache and peripheral edema) that occurred with somewhat higher incidence in the nisoldipine-ER group. Thus, nisoldipine-ER and amlodipine provided comparable antihypertensive and anti-ischemic efficacy, and both were generally well tolerated.

Fundam Clin Pharmacol 2002 Dec;16(6):537-44
Randomized, comparative, double-blind study of amlodipine vs. nicardipine as a treatment of isolated systolic hypertension in the elderly
Mounier-Vehier C, Jaboureck O, Emeriau JP, Bernaud C, Clerson P, Carre A
Hopital Cardiologique, CHRU de Lille, 2 avenue Oscar Lambret, 59037 Lille, France.

A 90-day, multicenter, randomized, double-blind, parallel-group study was conducted to compare the efficacy of amlodipine (once a day) with nicardipine (two to three times a day), in the treatment of isolated systolic hypertension (ISH) in the elderly. Patients (n = 133) aged > or = 60 years, with ISH were randomized to receive either amlodipine 5 mg/day, or nicardipine 60 mg/day (titrated if necessary to 10 mg/day and 100 mg/day, respectively) for 90 days. Efficacy was assessed by measuring office blood pressure (BP), and 24-h ambulatory blood pressure monitoring (ABPM). The two treatments substantially and comparably reduced office systolic blood pressure (SBP) and pulse pressure (PP), and also produced a slight decrease in diastolic blood pressure (DBP). Amlodipine reduced SBP, as assessed by ABPM, to a significantly greater extent than nicardipine. Both treatments were well-tolerated. The sustained effect of amlodipine, compared with nicardipine, was reflected in its significantly greater antihypertensive activity, particularly during the nocturnal period, as assessed by ABPM. The study demonstrates that once a day dose of amlodipine is an effective antihypertensive treatment for elderly ISH patients.

Why is this drug prescribed?

Norvasc is prescribed for angina, a condition characterized by episodes of crushing chest pain that usually results from a lack of oxygen in the heart muscle due to clogged arteries. Norvasc is also prescribed for high blood pressure. It is a type of medication called a calcium channel blocker. These drugs dilate blood vessels and slow the heart to reduce blood pressure and the pain of angina.

Most important fact about this drug

If you have high blood pressure, you must take Norvasc regularly for it to be effective. Since blood pressure declines gradually, it may be several weeks before you get the full benefit of Norvasc; and you must continue taking it even if you are feeling well. Norvasc does not cure high blood pressure; it merely keeps it under control.

How should you take this medication?

Norvasc may be taken with or without food. A once-a-day medication, Norvasc may be used alone or in combination with other drugs for high blood pressure or angina.

You should take this medication exactly as prescribed, even if your symptoms have disappeared. You will begin to see a drop in your blood pressure 24 hours after you start the medication.

--If you miss a dose...

If you forget to take a dose, take it as soon as you remember. If it is almost time for your next dose, skip the one you missed and go back to your regular schedule. Never take 2 doses at the same time.

--Storage instructions...

Store at room temperature in a tightly closed container, away from light.

What side effects may occur?

Side effects cannot be anticipated. If any develop or change in intensity, tell your doctor as soon as possible. Only your doctor can determine if it is safe for you to continue taking Norvasc.

• More common side effects may include:
  Dizziness, fatigue, flushing, fluid retention and swelling, headache, palpitations (fluttery or throbbing heartbeat)

• Less common side effects may include:
  Abdominal pain, nausea, sleepiness

• Rare side effects may include:
  Abnormal dreams, agitation, allergic reactions, altered sense of smell or taste, anxiety, apathy, back pain, chest pain, cold and clammy skin, conjunctivitis (pinkeye), constipation, coughing, depression, diarrhea, difficult or labored breathing, difficult or painful urination, difficulty swallowing, dizziness or light-headedness when standing, double vision, dry mouth, dry skin, excessive urination, eye pain, fainting, frequent urination, gas, general feeling of illness, hair loss, heart failure, hives, hot flashes, inability to sleep, increased appetite, increased sweating, indigestion, inflamed blood vessels, inflamed pancreas, irregular heartbeat, irregular pulse, itching, joint pain or problems, lack of coordination, lack of sensation, loose stools, loss of appetite, loss of memory, loss of sense of identity, low blood pressure, migraine, muscle cramps or pain, muscle weakness, nasal inflammation, nervousness, nosebleed, pain, purple or red spots on the skin, rapid heartbeat, rash, ringing in the ears, sexual problems, skin discoloration, skin inflammation, slow heartbeat, stomach inflammation, thirst, tingling or "pins and needles," tremor, twitching, urinating at night, urinating problems, vertigo, vision problems, vomiting, weakness, weight gain
  

Why should this drug not be prescribed?

If you are sensitive to or have ever had an allergic reaction to Norvasc, do not take this medication.

Special warnings about this medication

Check with your doctor before you stop taking Norvasc, as a slow reduction in the dose may be needed.

Your doctor will prescribe Norvasc with caution if you have certain heart conditions or liver disease. Make sure the doctor is aware of all your medical problems before you start therapy with Norvasc.

Although very rare, if you have severe heart disease, you may experience an increase in frequency and duration of angina attacks, or even have a heart attack, when you are starting on Norvasc or your dosage is increased.

Safety and effectiveness in children have not been established.

Possible food and drug interactions when taking this medication

There are no known food or drug interactions with this medication.

Special information if you are pregnant or breastfeeding

The effects of Norvasc during pregnancy have not been adequately studied. If you are pregnant or planning to become pregnant, tell your doctor immediately. Norvasc should be used during pregnancy only if clearly needed. Norvasc may appear in breast milk. If this medication is essential to your health, your doctor may tell you to discontinue breastfeeding your baby until your treatment with Norvasc is finished.

Recommended dosage

HIGH BLOOD PRESSURE

Adults
The usual starting dose is 5 milligrams taken once a day. The most you should take in a day is 10 milligrams. If your doctor is adding Norvasc to other high blood pressure medications, the dose is 2.5 milligrams once daily. The lower 2.5-milligram starting dose also applies if you have liver disease.

Older Adults
You will be prescribed a lower starting dose of 2.5 milligrams.

ANGINA

Adults
The usual starting dose is 5 to 10 milligrams once daily. If you have liver disease, the lower 5-milligram dose will be used at the start.

Older Adults
The usual starting dose is 5 milligrams. Your doctor may adjust the dose based on your response to the drug.

Overdosage

Experience with Norvasc is limited; but if you suspect an overdose, seek medical attention immediately. The most likely symptoms are a drop in blood pressure and a faster heartbeat.

Caution! Before starting to take this medicine, it is vital that you should consult your doctor! Do not use it on your own initiative, without medical advice.
Also, you should read carefully important health information about this drug given here:

www.nlm.nih.gov