Universal reference book for medicines
Product name: LACIPIL (LACIPIL)

Active substance: lacidipine

Type: Calcium channel blocker

Manufacturer: GlaxoSmithKline Trading (Russia) manufactured by GlaxoSmithKline Pharmaceuticals (Poland)
Composition, form of production and packaging
The tablets covered with a cover of
white color, round, with squeezed out figure "2" on one side.

1 tab.

lacidipine 2 mg

Excipients: lactose monohydrate, lactose monohydrate (dry spray), povidone K30, magnesium stearate, hypromellose, Opaspry white.

7 pcs.
- blisters (2) - packs of cardboard.
7 pcs.
- blisters (4) - packs of cardboard.
The tablets covered with a cover of white color, oval, biconcave, with the risk put on both sides of a tablet.

1 tab.

lacidipine 4 mg

Excipients: lactose monohydrate, lactose monohydrate (dry spray), povidone K30, magnesium stearate, hypromellose, Opaspry white.

7 pcs.
- blisters (2) - packs of cardboard.
7 pcs.
- blisters (4) - packs of cardboard.
INSTRUCTION FOR THE SPECIALIST.

Description of the drug approved by the manufacturer for the print edition of 2007.

PHARMACHOLOGIC EFFECT

Selective blocker of slow calcium channels of the third generation from the group of dihydropyridine derivatives.
Has a specific effect mainly on the calcium channels of the smooth muscles of the vessels.
The main effects of Latsipil - the expansion of peripheral arterioles, a decrease in OPSS, a decrease in blood pressure.
In therapeutic doses normalizes the transmembrane current of calcium, does not affect the tone of veins, sinoatrial and AV-nodes, does not have a negative inotropic effect.
When prescribing the drug at a dose of 4 mg, the minimum elongation of the QT interval is observed.

PHARMACOKINETICS

Suction

After ingestion, lacidipine is rapidly absorbed from the digestive tract.
Absolute bioavailability is approximately 10%. C max is reached in 30-150 minutes.
Distribution

The binding of lacidipine to plasma proteins is more than 95% (with albumin and? 1-glycoprotein).

Metabolism

Latsidipin undergoes intensive metabolism during the "first passage" through the liver.
Metabolised in the liver with the formation of 4 major metabolites, which have little pharmacological activity. There is no evidence to confirm the ability of lacidipine to induce or inhibit hepatic enzyme activity.
Excretion

When the equilibrium state is reached, the average T 1/2 of lacidipine is 13-19 hours.

Approximately 70% of the accepted dose of lacidipine is excreted in the form of metabolites through the intestine, the rest of the dose - in the form of metabolites with urine.

INDICATIONS

- arterial hypertension as a monotherapy or as part of combination therapy with other antihypertensive agents (including beta-blockers, diuretics, ACE inhibitors).

DOSING MODE

Doses are set taking into account the severity of the course of the disease and the individual reaction of the patient.

The initial dose is 2 mg 1 time / day.
If necessary, it is possible to increase the dose to 4 mg / day and then to 6 mg / day after the time that is required to achieve the full therapeutic effect. Usually in clinical practice, this period is 3-4 weeks, unless the patient's condition requires a faster dose increase.
Lacisil should be taken at the same time of the day, preferably in the morning, regardless of food intake.

Patients with impaired liver function correction of the dose of Lacipil is not required.

Patients with impaired renal function , as well as the elderly, do not need a dose adjustment for Lacipil.

SIDE EFFECT

From the side of the cardiovascular system: it is possible to develop effects associated with the expansion of peripheral vessels, including.
headache, hot flashes, peripheral edema, dizziness, palpitations (these effects are usually transient and usually disappear with continued use of Lacipil in the previous dose); rarely - exacerbation of angina, especially immediately after the start of treatment (which is more likely in patients with severe clinical manifestations of IHD).
From the digestive system: rarely - functional disorders of the stomach, nausea, gingival hyperplasia;
very rarely - a reversible increase in the level of AF.
From the urinary system: rarely - polyuria.

Dermatological reactions: rarely - skin rash (erythema), itching.

Other: rarely - general weakness.

CONTRAINDICATIONS

- aortic stenosis;

- children's and adolescents under 18 years of age (effectiveness and safety not established);

- Hypersensitivity to the components of the drug.

Caution should be used in patients with disorders of the function of the sinoatrial and AV nodes, with congenital or acquired (documented) QT interval prolongation, with low cardiac output, unstable angina and recently suffered myocardial infarction, with liver dysfunction, and with simultaneous appointment with drugs that extend the QT interval.

PREGNANCY AND LACTATION

Data on the safety of clinical use of lapipala in pregnancy are absent.

The use of latsipila during pregnancy and lactation is possible only in cases where the intended benefit to the mother exceeds the potential risk to the fetus or newborn.

In experimental studies on laboratory animals, it has been shown that lacidipine or its metabolites are excreted in breast milk.

APPLICATION FOR FUNCTIONS OF THE LIVER

Patients with impaired renal dysregulation of the dose of Lacipil are not required.

APPLICATION FOR VIOLATIONS OF THE FUNCTION OF KIDNEYS

Caution should be used in patients with impaired liver function.

APPLICATION FOR CHILDREN

Clinical experience of using Latsipil in pediatrics is not available, therefore, it is not recommended to use the drug in patients under 18 years of age .

SPECIAL INSTRUCTIONS

Lazipil does not affect the automatism of the sinoatrial node and does not slow the excitation through the AV node.

Considering the theoretical possibility of the effect of calcium channel blockers on the function of the sinoatrial and AV nodes, Lazipil should be used with caution in patients with impaired activity of these pacemakers.

Lacidipine (like other calcium channel blockers from the dihydropyridine group) should be used with caution in patients with congenital or acquired (documented) QT interval elongation.
Lacipyl should be administered with caution at the same time as drugs that can induce prolongation of the QT interval, such as antiarrhythmic drugs of classes I and III, tricyclic antidepressants, some antipsychotics, antibiotics (erythromycin) and some histamine H 1 receptor blockers (terfenadine).
The drug should be used with caution in patients with low cardiac output, with unstable angina and after a recent myocardial infarction.

Caution is used Latsipil in patients with hepatic insufficiency, since in this category of patients the hypotensive effect of the drug may be more pronounced.

Latsipil does not interfere with glucose tolerance, does not reduce the effectiveness of antidiabetic therapy.

During the period of treatment, it is necessary to carry out standard monitoring of the functional state of the myocardium and the level of blood pressure.

Like other dihydropyridine drugs, Latsipil can not be washed down with grapefruit juice, as this can reduce its bioavailability.

Use in Pediatrics

Clinical experience of using Latsipil in pediatrics is not available, therefore, it is not recommended to use the drug in patients under 18 years of age .

Impact on the ability to drive vehicles and manage mechanisms

Data on the impact of Lazipil on the ability to drive and work with machinery are absent.

OVERDOSE

The medical literature does not describe cases of overdose of Lacipil.

Symptoms: Apparently, arterial hypotension and tachycardia (associated with prolonged expansion of peripheral vessels) are most likely.
Theoretically, Latsipil is capable of causing bradycardia and a slowing of AV conduction.
Treatment: there is no specific antidote to Lazipil.
It is recommended to carry out symptomatic therapy.
DRUG INTERACTION

The combined use of latsipil and other antihypertensive drugs, such as diuretics, beta-blockers or ACE inhibitors, can cause an additive antihypertensive effect.

With the simultaneous use of Latsipil with other commonly used antihypertensive drugs, digoxin, tolbutamide and warfarin, no specific interaction was noted.

The antihypertensive effect of Lacipil weaken NSAIDs (sodium retention and blockage of prostaglandin synthesis by the kidneys) and estrogens (sodium retention).

The concentration of lacidipin in the blood plasma can increase with the simultaneous administration of cimetidine.

In patients after transplantation of the kidney that received cyclosporine, Latsipil eliminates the decrease in renal blood flow and glomerular filtration rate caused by cyclosporine administration.

TERMS OF RELEASE FROM PHARMACY

The drug is released by prescription.

TERMS AND CONDITIONS OF STORAGE

The drug should be stored out of reach of children at a temperature of no higher than 30 ° C.
Shelf life - 2 years.
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