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Indications Adalat Retard tab, 5 mg cap CHD eg chronic stable angina pectoris
(stress-induced & rest angina), angina pectoris after acute MI except for the
1st 8 days; HTN; Raynaud's syndrome. Adalat 10 mg cap CHD eg chronic
stable angina pectoris (stress-induced & rest angina), unstable angina
pectoris (crescendo, pre-infarction, resting angina) including vasospastic
angina pectoris (Prinzmetal's angina, variant angina); HTN, hypertensive
crisis & emergency; Raynaud's syndrome. Adalat GITS 20/GITS 60
Chronic stable angina pectoris (angina of effort), HTN. Adalat GITS 30
Chronic stable angina pectoris, angina pectoris after cardiac infarction
(except in the 1st 8 days after acute MI), HTN.
Dosage Adalat cap 1 cap (5 mg/10 mg) tid, can increase stepwise to 20 mg tid.
Coronary spasms Temporarily 20 mg 4-6 times daily. If rapid onset
requires, 10-20 mg sublingually. Adalat GITS tab Initially 1 tab of GITS 20
or GITS 30 once daily. Recommended dose: 1 tab of GITS 30 or GITS 60
once daily. Dose can be increased in stages to 120 mg once daily. Adalat
Retard tab 1 tab bid; in some cases 2 tab bid.
Overdosage For action to be taken in the event of accidental overdose ... click to view
Administration May be taken with or without food (Avoid grapefruit juice. Swallow whole,
do not chew/crush.).
Contraindications CV shock; pregnancy & lactation. Concomitant use of rifampicin.
Special Severe hypotension; close monitoring of dialysis patients w/ malignant
Precautions HTN; heart failure, severe aortic stenosis.
Adverse Drug Initially mild & transient vasodilatation, hypotension, rarely GI, skin &
Reactions other reactions. Very rarely: Transient visual change; chest discomfort (if
relation established, discontinue therapy). Extremely rare: On prolonged
use gingival hyperplasia, gynecomastia (both regressing on
discontinuation); temporary hyperglycemia, liver function disturbances
(including intrahepatic cholestasis). Ability to drive or operate machinery
may be impaired.
Click to view ADR Monitoring Website
Drug Interactions Effects enhanced by antihypertensive agents, cimetidine & β-receptor
blockers. Digoxin, quinidine (monitor plasma level).
Click here for more Interaction Checks
Pregnancy
Category (US
FDA) Category C: Either studies in animals have revealed adverse effects on the
foetus (teratogenic or embryocidal or other) and there are no controlled
studies in women or studies in women and animals are not available. Drugs
should be given only if the potential benefit justifies the potential risk to the
foetus.
Caution For For caution against possible variation of physical aspect of medicine... click
Usage to view
Storage For special storage condition to ensure optimal shelf-life of medicine...
click to view
Description For details on the chemical structure, and the excipient or inactive
compounds in the formulation... click to view
Mechanism of For Details of the mechanism of action, pharmacodynamics and
Action pharmacokinetics ... click to view
MIMS Class Anti-Anginal Drugs / Calcium Antagonists / Cardiac Drugs
ATC C08CA05 - Nifedipine ; Belongs to the class of dihydropyridine derivative
Classification selective calcium-channel blockers with mainly vascular effects. Used in
the treatment of cardiovascular diseases.
Poison Schedule Rx
Packing/Presentation
Form Packing/Price Photo
Adalat 5 mg x 100's (P1896.92)
Adalat capsule
Adalat 10 mg x 100's (P2681.25)
Manufacturer: Bayer
Distributor: Zuellig
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Abbreviation Index
Adalat Contents
Adalat Indications
Adalat Dosage
Adalat Overdosage
Adal
Pharmacology:
Adalat Gits 30, the prototype of the dihydropyridine class of calcium-channel antagonists, is
similar to other dihydropyridines including amlodipine, felodipine, isradipine, and nicardipine.
Adalat Gits 30 is used to treat Prinzmetal's angina, hypertension, and other vascular disorders
such as Raynaud's phenomenon. By blocking the calcium channels, Adalat Gits 30 inhibits the
spasm of the coronary artery and dilates the systemic arteries, results in a increase of myocardial
oxygen supply and a decrease in systemic blood pressure.
Nifedipine, known as a calcium channel blocker, is used to treat high blood pressure and some
forms of chest pain known as angina. This medication works by relaxing blood vessels and
decreasing the pressure on the heart. This can lead to dizziness, headache, lightheadedness,
flushing and swelling of the legs. You should report this to your physician because it can often
be easily treated with a diuretic (water-pill). This medication is available in an extended-release
form allowing for once a day dosing. Some brands must be taken on an empty stomach. Other
brands are made in porous capsule which slowly releases the medication. You may notice the
empty capsule in your stool. Extended release medications should not be crushed, cut or split
because this destroys the slow release mechanism. If you are taking this for high blood pressure,
you should have your blood pressure checked regularly to make sure the medication is working.
Long Acting Nitrates: Nifedipine may be safely co-administered with nitrates, but there have
been no controlled studies to evaluate the antianginal effectiveness of this combination.
Digitalis: Immediate Release Capsules: Since there have been isolated reports of patients with
elevated digoxin levels, and there is a possible interaction between digoxin and nifedipine, it is
recommended that digoxin levels be monitored when initiating, adjusting, and discontinuing
nifedipine to avoid possible over- or under-digitalization. Extended Release Tablets:
Administration of nifedipine with digoxin increased digoxin levels in 9 of 12 normal volunteers.
The average increase was 45%. Another investigator found no increase in digoxin levels in 13
patients with coronary artery disease. In an uncontrolled study of over 200 patients with
congestive heart failure during which digoxin blood levels were not measured, digitalis toxicity
was not observed. Since there have been isolated reports of patients with elevated digoxin levels,
it is recommended that digoxin levels be monitored when initiating, adjusting, and discontinuing
nifedipine to avoid possible over- or under-digitalization.
Quinidine: Immediate Release Capsules: There have been rare reports of an interaction between
quinidine and nifedipine (with a decreased plasma level of quinidine).
Coumarin Anticoagulants: There have been rare reports of increased prothrombin time in
patients taking coumarin anticoagulants to whom nifedipine was administered. However, the
relationship to nifedipine therapy is uncertain.
Cimetidine: A study in 6 healthy volunteers has shown a significant increase in peak nifedipine
plasma levels (80%) and area-under-the-curve (74%) after a 1 week course of cimetidine at 1000
mg per day and nifedipine at 40 mg per day. Ranitidine produced smaller, non-significant
increases. The effect may be mediated by the known inhibition of cimetidine on hepatic
cytochrome P-450, the enzyme system probably responsible for the first-pass metabolism of
nifedipine. If nifedipine therapy is initiated in a patient currently receiving cimetidine, cautious
titration is advised.
Adalat Gits 30 Indication: For the management of vasospastic angina, chronic stable angina
and hypertension.
Mechanism Of Action: Adalat Gits 30 inhibits the influx of extracellular calcium through
myocardial and vascular membrane pores by physically plugging the channel. The decrease in
intracellular calcium inhibits the contractile processes of smooth muscle cells, causing dilation of
the coronary and systemic arteries, increased oxygen delivery to the myocardial tissue, decreased
total peripheral resistance, decreased systemic blood pressure, and decreased afterload.
Drug Interactions: Amobarbital The barbiturate decreases the effect of the calcium channel
blocker
Aprobarbital The barbiturate decreases the effect of the calcium channel blocker
Butabarbital The barbiturate decreases the effect of the calcium channel blocker
Butalbital The barbiturate decreases the effect of the calcium channel blocker
Butethal The barbiturate decreases the effect of the calcium channel blocker
Cimetidine Cimetidine increases the effect of the calcium channel blocker
Cisapride Cisapride increases the effect and toxicity of nifedipine
Cyclosporine Increased risk of gingivitis
Ginseng Ginseng increases the effect and toxicity of nifedipine
Heptabarbital The barbiturate decreases the effect of the calcium channel blocker
Hexobarbital The barbiturate decreases the effect of the calcium channel blocker
Imatinib Imatinib increases the effect and toxicity of nifedipine
Melatonin Melatonin can possibly decrease the effect of nifedipine
Methohexital The barbiturate decreases the effect of the calcium channel blocker
Methylphenobarbital The barbiturate decreases the effect of the calcium channel blocker
Pentobarbital The barbiturate decreases the effect of the calcium channel blocker
Phenobarbital The barbiturate decreases the effect of the calcium channel blocker
Primidone The barbiturate decreases the effect of the calcium channel blocker
Secobarbital The barbiturate decreases the effect of the calcium channel blocker
Talbutal The barbiturate decreases the effect of the calcium channel blocker
Rifampin Rifampin decreases the effect of the calcium channel blocker
Quinidine Decreased quinidine effect, increased nifedipine effect
Quinidine barbiturate Decreased quinidine effect, increased nifedipine effect
Dihydroquinidine barbiturate Decreased quinidine effect, increased nifedipine effect
Quinupristin Synercid increases the effect of ziprasidone
Tacrolimus Adalat Gits 30 increases serum levels of tacrolimus
St. John's Wort St. John's Wort decreases the effect of nifedipine
Food Interactions: Avoid alcohol.
Avoid taking with grapefruit juice.
Avoid natural licorice.
Take with low fat meal.
Generic Name: Nifedipine
Synonyms: Not Available
Drug Category: Tocolytic Agents; Vasodilator Agents; Calcium Channel Blockers;
Dihydropyridines
Drug Type: Small Molecule; Approved
Other Brand Names containing Nifedipine: Adalat; Adalat 10; Adalat 20; Adalat 5; Adalat
CC; Adalat CR; Adalat Crono; Adalat Ft; Adalat Gits; Adalat Gits 30; Adalat LA; Adalat LP;
Adalat Oros; Adalat PA; Adalat Retard; Adalate; Adapine; Adapress; Alat; Aldipin; Alfadal;
Alonix; Alonix S; Alpha-Nifedipine Retard; Angipec; Anifed; Anpine; Apo-Nifed; Aprical;
Bonacid; Calcibloc; Calcigard; Calcilat; Camont; Cardifen; Cardilat; Cardionorm; Chronadalate;
Chronadalate Lp; Citilat; Coracten; Coral; Cordafen; Cordaflex; Cordalat; Cordicant; Cordilan;
Cordipin; Corinfar; Corotrend; Corynphar; Depin; Dignokonstant; Dilafed; Dilcor; Dipinkor;
Duranifin; Ecodipi; Ecodipin; Ecodipin E; Fedcor; Fedcor Retard; Fenamon; Fenamon Sr;
Fenihidin; Fenihidine; Glopir; Hadipin; Hexadilat; Introcar; Kordafen; Macorel; Megalat;
Myogard; N1fedilat; Nedipin; Nicardia; Nifangin; Nifar; Nifdemin; Nifebene; Nifecard; Nifecor;
Nifedepat; Nifedicor; Nifedin; Nifedine; Nifedipine Retard; Nifedipres; Nifedirex LP; Nifelan;
Nifelat; Nifelat Q; Nifelate; Nifensar XL; Nificard; Nifidine; Nifipen; Niphedipine; Orix;
Oxcord; Pidilat; Procardia; Procardia XL; Sepamit; Tibricol; Zenusin;
Absorption: Rapidly and fully absorbed following oral administration.
Toxicity (Overdose): Symptoms of overdose include dizziness, drowsiness, nausea, severe drop
in blood pressure, slurred speech, and weakness. LD50=494 mg/kg (orally in mice); LD50=1022
mg/kg (orally in rats)
Protein Binding: 92-98%
Biotransformation: Hepatic.
Half Life: 2 hours
Dosage Forms of Adalat Gits 30: Tablet, extended release Oral
Tablet Oral
Capsule Oral
Chemical IUPAC Name: dimethyl 2,6-dimethyl-4-(2-nitrophenyl)-1,4-dihydropyridine-3,5-
dicarboxylate
Chemical Formula: C17H18N2O6
Nifedipine on Wikipedia: http://en.wikipedia.org/wiki/Nifedipine
Organisms Affected: Humans and other mammals
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Reviews
Nifedipine
Biomed Pharmacother. 2005 Jan-Feb;59(1-2):1-7. Epub 2005 Jan 20.
Effects of nifedipine, verapamil and diltiazem on serum biochemical parameters and aortic composition
of atherosclerotic chickens.
Garcia-Perez B, Ayala I, Castells MT, Domenech G, Sanchez-Polo MT, Garcia-Partida P, Valdes M.
Universitary Clinical Hospital, Virgen de la Arrixaca, Murcia, Spain.
Calcium appears to be involved in many of the cellular events, which are thought to be important in
atherogenesis. In this study, we examine the effects of three calcium entry blockers (nifedipine,
verapamil, and diltiazem at clinical and higher doses) on serum biochemical parameters and aortic
calcium, cholesterol and triglyceride concentrations of atherosclerotic egg-fed chickens. All egg-fed
chickens (treated and non-treated) showed an increase in serum total cholesterol, LDL-cholesterol and
triglycerides without significant effect when calcium entry blockers were used. Increased HDL values
were observed in clinical and high-dose nifedipine and clinical dose verapamil groups. The high-dose
diltiazem group presented increased zinc values with respect to the clinical dose diltiazem and control
groups. The sodium concentrations were significantly decreased in all the groups of animals treated with
calcium entry blockers at high-doses and nifedipine at clinical doses. Measurements of aortic calcium
concentration showed a significant decrease in the high-dose nifedipine and verapamil groups. Calcium
channel blockers had a tendency to decrease total cholesterol in aortas. The values were statistically
significant for the high-dose verapamil, and nifedipine groups. Only nifedipine showed a significant
decrease for this parameter at clinical dosages. Triglyceride concentrations in aortas were significantly
low in animals fed an atherogenic diet and treated with calcium channel blockers, without differences
between drugs or dosages used in the experiment. In addition, the chicken atherosclerosis model has
proved itself useful and very suitable for in vivo drug intervention studies.
Eur J Pharmacol. 2003 Nov 14;481(1):79-82.
Ovariectomy aggravates nifedipine-induced flushing of tail skin in mice.
Kai M, Tominaga K, Okimoto K, Yamauchi A, Kai H, Kataoka Y.
Department of Pharmaceutical Care and Health Sciences, Faculty of Pharmaceutical Sciences, Fukuoka
University, 8-19-1 Nanakuma, Fukuoka 814-0180, Jonan, Japan.
Flushing is one of the most common vasodilation-related adverse effects associated with Ca(2+) channel
antagonist treatment. This symptom is known to occur more frequently in women than men. The
present study aimed at investigating the effect of ovariectomy on nifedipine-induced flushing in mice.
Ovariectomy markedly increased the tail skin temperature, a parameter of skin flushing, induced by
nifedipine at a dose showing no influence on blood pressure. This event was blocked by estradiol
replacement. Estrogen withdrawal is, therefore, included in the risk factors for nifedipine-induced
flushing and this risk is lessened by estrogen replacement.
Drugs. 2003;63(14):1435-44
Current treatment of patients with hypertension: therapeutic implications of INSIGHT
Taddei S, Ghiadoni L, Salvetti A
Department of Internal Medicine, University of Pisa, Pisa, Italy.
When planning treatment for patients with hypertension, current guidelines emphasise the
importance of risk stratification, based on blood pressure, the presence of end-organ damage and
other cardiovascular risk factors. Because the beneficial effect of antihypertensive therapy seems
to be linked to the degree of blood pressure reduction, guidelines recommend reducing blood
pressure below 140/90mm Hg, with a lower target in patients who are young or who have
diabetes mellitus (with or without nephropathy) or non-diabetic nephropathy. Blood pressure
reduction can be achieved with several classes of drugs, including diuretics, beta-blockers, ACE
inhibitors, angiotensin II antagonists and calcium channel antagonists. Calcium channel
antagonists have been shown to reduce the risk of stroke and major cardiovascular events.
However, it is still controversial whether different treatment regimens based on different drug
classes can offer advantages beyond similar degrees of blood pressure control in preventing
cardiovascular morbidity and mortality. The International Nifedipine GITS Study: Intervention
as a Goal in Hypertension Treatment (INSIGHT) was a controlled clinical trial aimed at
comparing the efficacy of a long-acting calcium channel antagonist, nifedipine gastrointestinal-
transport-system (GITS), versus co-amilozide, a combination of the diuretics
hydrochlorothiazide (HCTZ) and amiloride, on morbidity and mortality in high-risk hypertensive
patients. Nifedipine GITS and HCTZ/amiloride were equally effective at reducing blood pressure
and the risk of primary outcomes (a composite of death from any cardiovascular or
cerebrovascular cause, non-fatal stroke, myocardial infarction and heart failure). Results from
other studies indicate that there may be greater benefits for stroke and smaller benefits for
coronary artery disease with calcium channel antagonist-based regimens than with diuretic or
beta-blocker-based regimens. However, there is at present insufficient evidence to recommend a
specific drug choice based on patient risk profile. Thus, the choice of antihypertensive drug(s)
should be according to efficacy and tolerability. In addition to the reductions in cardiovascular
risk, two substudies of INSIGHT showed that nifedipine GITS was able to prevent the
progression of intima media thickness in the common carotid artery and slow the progression of
coronary calcification. The clinical significance of this effect in the prevention of cardiovascular
events still remains to be established.
1 This study in normotensive subjects compared the duration and consistency of action of amlodipine (5
mg) and nifedipine GITS (60 mg) by assessment of the attenuation of pressor responses to noradrenaline
and angiotensin II. 2 Both drugs significantly attenuated pressor responses to both vasoconstrictors at 6
and 24 h post-dose with rightward shifts of up to 2.3-fold in the dose-response curves. 3 There was
significantly less pharmacokinetic variability with amlodipine: for example, intra-subject variability was
33% with amlodipine and 59% with nifedipine GITS. 4 There were no significant differences in the
pressor dose ratios up to 48 h post-dose with amlodipine whereas there was a significant and
progressive reduction in the pressor dose ratios with nifedipine. 5 These results suggest that both drugs
are broadly comparable as once daily treatments but amlodipine displayed less intra- and inter-subject
variability and provided a significantly more sustained effect with a reserve of pharmacological activity
up to 48 h post-dose.
Drug information
PREPARATIONS: 10mg and 20mg capsules. Also available in extended release forms
(Procardia XL, Adalat CC) in 30, 60, and 90mg capsules
PRESCRIBED FOR: Chest pain (angina) occurs because of insufficient oxygen delivered to the
heart muscles. Insufficient oxygen may be a result of coronary artery blockage or spasm, or
because of physical exertion which increases heart oxygen demand in a patient with coronary
artery narrowing. Nifedipine is used for the treatment and prevention of angina resulting from
coronary artery spasm as well as from exertion. Nifedipine is also used in the treatment of high
blood pressure. It is also used to open the blood vessels which spasm, causing Raynaud's
phenomenon.
DOSING: Nifedipine can be taken with or without food. Nifedipine is metabolized mainly by
the liver and dosages may need to be lowered in patients with liver dysfunction.
SIDE EFFECTS: Side effects of nifedipine are generally mild, and reversible. Most side effects
are expected consequences of the dilation of the arteries. The most common side effects of
nifedipine include headache, dizziness, flushing, and edema (swelling) of the lower extremities.
Less common side effects include dizziness, nausea and constipation.
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.
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