Nifedipin Neo #40 tab
Pharmacological group: calcium-channel blocker dihydropyridine produced.
Drug form: Coated tablets.
ATC code: C08CA05;
Pharmacological group: calcium-channel blocker
dihydropyridine produced.
Composition: Active
substance: Nifedipine -10mg.
Aiding
substances: lactose monohydrate, microcrystalline cellulose, corn starch, polyvinylpyrrolidone, calcium or magnesium stearate, saccharose, magnesium carbonate, talcum, yellow pigment,
titanium dioxide, aerosil.
Pharmacological operation: Nifedipine
is produced by chemical structure of 1,4 dihydropyridine. It is calcium-channel
selecting blocker. The preparation is characterized by vasodilatation, antianginal and
antihypertensive action. Calcium-channel blocker, Nifedipine slows
calcium ions’ transmembrane availability in arteries and cardiac hystiocyte
smooth muscular cells. By its influence there is reduced
blood-vessel walls tonus, extents peripheral and coronal artery; reduces
vessels total peripheral resistance and blood pressure. By lowering of coronal artery smooth muscle
tonus, development of coronary vasospasm is avoided. At the expense of
reduction of vessels total peripheral resistance, request of myocardium for
oxygen reduced. As a response of peripheral vasodilatation, sympathoadrenal system reflex
activation takes place, which covers negative chronotropic, dromotropic and inotropic effect of the preparation. By this
reason “Nifedipin Neo” doesn’t cause orthostatic actions development. The preparation mostly influences on blood vessel muscles,
less- heart patulous system. Long use of preparation causes excretion of sodium ions and water. Preparation is effective after 20
minutes from taking and continues for 4-6 hours.
Pharmacokinetics: After
peroral intake “Nifedipin” is quickly and wholly (90%) absorbed from gastrointestinal tract. Bioavailability makes up
60-75%. 90% of the preparation relates to proteins. Maximum concentration in
plasma is mentioned after 1-3 hours. Passes hematoencephalic and placental
barrier, excreted with breast milk, metabolizes in the liver. Inactive metabolites
are excreted by the kidneys (70-80%). Semiejection period 2-4 hours. Kidneys’ chronic insufficiency,
hemodialysis and peritoneal dialysis don’t influence on preparation pharmacokinetics.
In case of its long term use (2-3 months) there is developed tolerance toward
the preparation.
Indication:
·
Essential hypertension (like monotherapy or in
combination of other antihypertensive drugs);
·
Hypertensic crisis;
·
Classic vasospastic stenocardia
(Prinzmetal's angina) or coronary artery spasm confirmed by angiography;
·
Chronic, stable stenocardia (in this
case is recommended to take “Nifedipin” in combination with beta blocker);
·
Raynaud's disease.
Dosage regime:
Dosage is individual according to disease hardness and patient’s reaction on
the preparation. Preparation intake is
recommended before eating with small amount of water.
In case of vasospastic stenocardia is
prescribed: 1-2 pills (10-20 mg.) three times a day;
In case of chronic stable
stenocardia: 1-2 pills three times a day;
In case of essential hypertension: 1-2 pills three times a day;
Maximum daily dose - 6 pills (60mg.). In case of hypertensic
crisis it is possible to chew the pill for a quick effect, keep for a while in
the mouth and swallow together with small amount of water. In case of insufficient
effect you can repeat the same after 30 minutes.
For elderly and diseased people -
combination therapy (antianginal
and hypotensive), also patients with kidney
functional disorder and blood circulation disorder in the brain, dosage
decrease is necessary.
In case of dosage skipping double
dose mustn’t be taken. Treatment should be continued according to primary
schedule. Duration of treatment is determined by the doctor.
Side effects:
“Nifedipin”
is usually well tolerated. Majority of side effects are caused by the expansion
of cardiovascular activity and disappears after treatment. In most cases there
may develop the following side effects: skin hyperemia, redness, flush and headache caused by cerebrum vessels tonus lowering and lift because of blood flow increase.
In such case dose of “Nifedipin” should be reduced or it should be
taken after eating.
Allergic reactions: rash on the skin,
itch.
From the side of
digestion system: nausea, heartburn, diarrhea, dry mouth.
From the side of
central and peripheral system: headache, dizziness, limb paresthesia, pain in
muscles, sleep disturbance (long use of great doses).
Contra indication:
·
Hypersensitivity
toward components of “Nifedipin” or other compounding components.
·
Hypovolemia (reduction of blood being
in circulation).
·
Instable stenocardia.
·
Transferred cardiac infarction.
·
Pregnancy and lactation period.
·
Simultaneous intake together with
Rifampicin (efficiency of “Nifedipin” decreases
significantly).
·
Hard heart failure.
·
Hard aortal stenosis.
Overdose:
Symptoms:
bradycardia, bradyarrhythmia, sharp decrease of arterial pressure, in hard
condition – collapse, headache, pain in the chest area, increase of sugar in
blood.
In case of overdose address to doctor
immediately!
For
excretion of preparation from the organism there should be taken following
measures: gastric lavage, intake of activated charcoal.
Symptomatic
treatment should be carried out for cardiovascular
system stabilization (calcium gluconate, dopamine or dobutamine, adrenaline,
norepinephrine, atropine), hemodialysis is less effective, plasmapheresis is recommended.
Interaction with other therapeutic agents: “Nifedipin” intake together with
antihypertensive agents causes effect strengthening. Taking
together with nitrate
strengthens tachycardia and hypotensive action. Simultaneous intake of “Nifedipin”
and beta blockers must be under doctor’s supervision, as blood pressure sharp
lowering may develop and in some cases exacerbation of heart
failure symptoms. “Nifedipin”
lowers quinidine concentration in plasma.
Increases concentration of digoxin and theophylline and their concentration control in plasma is
necessary. Rifampicin decreases efficiency of “Nifedipin”
(accelerates its metabolism at the expense of liver
enzyme activity induction). Interaction with Prazosinum may cause sharp lowering of
blood pressure. Simultaneous intake together with tricyclic antibiotics, cimetidine, Ranitidine strengthens efficiency of “Nifedipin”.
Taking together with Phenytoin, availability of “Nifedipin”
in the organism lowers and accordingly – efficiency,
therefore increase of dose may be needed. As “Nifedipin”
metabolises by means of liver enzyme system, therapeutic agents which suppress
or strengthen enzyme activity, influence on
“Nifedipin”
operation.
Special instructions: During treatment it is necessary to abstain from alcohol intake. In spite of the fact that the preparation
doesn’t characterize removal syndrome, termination of treatment is recommended
with gradual reduction of dose.
It is necessary
to use “Nifedipin” with care to those patients, whose systolic arterial pressure is less
than 90 mm.
If revealed
chest pain during the treatment is related to preparation intake.
Use of “Nifedipin”
is extremely risky for patients with congestive heart
failure.
Pregnancy and lactation period: Usage of
preparation is not recommended during the period of pregnancy and lactation.
Influence of vehicle and mechanisms management: The preparation doesn't influence on attention
concentration, however in some cases may reduce arterial pressure, so it is
necessary to be careful during management of motor transport and mechanisms.
Drug release form: Primary package: N 20 pills on the blister.
Secondary
package: 2 blisters in the box.
Order of issue from pharmacy: II group of
pharmaceutical product, issued with prescription #3 (for emergency medical care is
issued without a prescription).
Storage conditions: Store not more than 250C temperature, in a dark, dry
place and keep away from children.
Date of expire: 2 years.
Do not use preparation after expire or in case of
visual defect.
Producer: “Neopharmi” LTD.
Davit Aghmashenebeli alley 12 km, Tbilisi, Georgia.
Tel/fax: + 995 (32) 259 64 46, 259 57 90.
