Felodip Tab n / a film about prolong. 10 mg 30 pcs

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Felodip Tab n / a film about prolong. 10 mg 30 pcs

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SKU: 1018458971 Categories: , , Tags: ,

Description

Composition
Active substance:
felodipine 10,000 mg
Excipients:
Lactose monohydrate 21.450 mg; microcrystalline cellulose (type Avicel PH 101) 48.000 mg; Hypromellose (Methocel E50LV) 110,000 mg; Povidone (type K-25) 7,350 mg; 0.067 mg propyl gallate; microcrystalline cellulose (type Emcocel 90 M) 8,000 mg; colloidal silicon dioxide 1,300 mg; magnesium stearate, 0.833 mg;
Film coating: Hypromellose (type Pharmacoat 606) 6.572 mg; dye iron oxide red (E 172) – 0.081 mg; dye Yellow iron oxide (E 172) 0.044 mg; titanium dioxide (E 171) 0.467 mg; 0.992 mg of talc; propylene glycol 1.144 mg.
Description:
Round biconvex tablets, film-coated red-brown color, with chasing “10” on one side, and odorless.
At the turn of the core of the tablet can be seen a white or nearly white (all doses).
Product form:
Prolonged action tablets, film-coated 10mg.
10 tablets in a blister Al-PVC / PVDC / PE. 3 blisters with instruction for use in a cardboard package.
Contraindications
Hypersensitivity to the felodipine and other dihydropyridine derivatives; unstable angina; acute myocardial infarction and for one month after myocardial infarction; cardiogenic shock;
clinically significant aortic stenosis; pregnancy; breastfeeding;
heart failure decompensation; severe hypotension; age 18 years (effectiveness and safety have been established);
lactose intolerance, lactase deficiency; glucose-galactose malabsorption.
Carefully
Liver and / or kidney failure, age over 65 years.
Dosage
10 mg
Indications
– Arterial hypertension.
– Stable angina pectoris (including Prinzmetal angina).
Interaction with other drugs
Felodipine increases the concentration of digoxin in blood plasma, however felodipine dose adjustment is required.
Inhibitors of cytochrome P450 (eg cimetidine, erythromycin, itraconazole, ketoconazole) slow felodipine metabolism in the liver, increasing the blood plasma concentration of drug.
Inductors microsomal enzymes (phenytoin, carbamazepine, rifampicin, barbiturates) reduce the concentration of felodipine in plasma.
Nonsteroidal anti-inflammatory drugs do not impair the hypotensive effect of felodipine.
The high degree of felodipine being associated with proteins not affect the bondability free fraction of other medicines (e.g., warfarin).
Felodipine should not be used simultaneously with grapefruit juice due bioflavonoid located therein, which improves the bioavailability of felodipine.
Beta-blockers, verapamil, tricyclic antidepressants and diuretics enhance the hypotensive effect of felodipine.
With simultaneous application may increase tacrolimus concentrations in blood plasma, which may require correction of the dose of tacrolimus.
Overdose
Symptoms: marked reduction of blood pressure, bradycardia.
Treatment: symptomatic therapy. In marked decrease in blood pressure patient should be given a horizontal position, lift the legs. With the development of bradycardia shown in / atropine at a dose of 0,5-1 mg. If this is insufficient, it is necessary to increase plasma infused dextrose (glucose), sodium chloride or dextran. Symptomatic drugs with predominant effect on alpha-adrenergic receptors is used in the above inefficiency measures.
pharmachologic effect
Pharmacological group:
blocker “slow” calcium channels.
Pharmacodynamics:
Felodipine belongs to the blockers “slow” calcium channel dihydropyridine. It has anti-hypertensive, anti-anginal action.
Lowers blood pressure (BP) by decreasing peripheral vascular resistance. It has a dose-dependent anti-ischemic effect. Reduces the size of myocardial infarction, reperfusion protects against complications. Practically no negative inotropic effect, has minimal effect on the cardiac conduction system.
Pharmacokinetics:
Absorption and distribution
Sustained release of felodipine tablets, film-coated, leads to a lengthening of phase and absorption of the drug provides a uniform concentration of felodipine in plasma for 24 hours. Felodipine is almost completely absorbed in the gastrointestinal tract. The bioavailability of the drug is independent of dose within the therapeutic interval and is approximately 15%. 99% of felodipine bound to plasma proteins, primarily albumin.
Metabolism and excretion
Felodipine is completely metabolized by the liver and all its metabolites are inactive.
Felodipine half-life is 25 hours. Prolonged use of felodipine cumulation does not occur.
Pharmacokinetics in special patient groups
In elderly patients and in cases of liver dysfunction felodipine plasma concentration is higher than that of younger patients. Pharmacokinetic parameters of felodipine are not changed in patients with impaired renal function, including during hemodialysis. About 70% of the dose is excreted by the kidneys, and the rest – the intestine in the form of metabolites. In unaltered kidneys displayed less than 0.5% of the dose. Felodipine penetrates the blood-brain barrier to cross the placenta and is excreted in breast milk.
Conditions of supply of pharmacies
Prescription.
side effects
As well as the application of other blockers “slow” calcium channels, drug Felodip can cause facial flushing, headache, palpitations, dizziness and fatigue. These reactions are reversible and often occur early in treatment or with increasing dose. Also, depending on dose, peripheral edema may occur that are caused precapillary vasodilation. Patients with gum disease, or periodontitis may be a light swelling of the gums. This can hinder compliance thorough oral hygiene.
The frequency of adverse events classified according to the recommendations
World Health Organization: very often – at least 10%; often – at least 1% but less than 10%; infrequently – at least 0.1% but less than 1%; rarely – at least 0.01% but less than 0.1%; very rare (including sporadic cases) – less than 0.01%.
Immune system: very rarely – hypersensitivity reactions, angioedema.
On the part of the central and peripheral nervous system: often – headache; rarely – dizziness, paresthesia; rarely – swoon.
Cardio-vascular system: very often – peripheral edema; often –
“Tides”; rarely – tachycardia, palpitations.
On the part of the gastrointestinal tract: rarely – nausea, stomach pain; rarely – vomiting; very rarely – gingival hyperplasia, gingivitis.
Of the liver and biliary tract: rarely – increased activity of “liver” transaminases.
For the skin and subcutaneous tissue disorders: rare – rash, itchy skin; rarely – urticaria; very rarely – photosensitivity reaction, leukocytoclastic vasculitis.
On the part of the musculoskeletal system and connective tissue disorders: rarely – arthralgia, myalgia.
On the part of the kidney and urinary tract: very rare – pollakiuria.
Other: rarely – fatigue; rarely – sexual dysfunction.
special instructions
Felodip drug, as well as other vasodilators, may in rare cases cause significant hypotension, which in a number of predisposed patients may lead to myocardial ischemia. There is currently no data on the appropriateness of the drug as a secondary prevention of myocardial infarction.
Preparation Felodip effective and well tolerated by patients regardless of gender and age, as well as patients with concomitant diseases such as bronchial asthma and other pulmonary diseases; impairment of renal function; diabetes; gout; hyperlipidemia; Raynaud’s syndrome, and after lung transplantation.
Felodip The drug has no effect on the concentration of blood glucose and lipid profile.
Effects on ability to transport management and work with technology
Patients who during treatment with Felodip observed weakness, dizziness, should refuse to perform actions that require high concentration and psychomotor speed reactions.
Storage conditions
At a temperature of 10 to 25 degrees in a dark place. Keep out of the reach of children.
Dosing and Administration
The drug is best taken in the morning inside before a meal or after a light breakfast.
Tablets, film-coated, it is impossible to see through, to divide or crush.
Arterial hypertension
Adults (including elderly patients): The dose is always determined individually.
Therapy begins with a dose of 5 mg 1 time per day. If necessary, the dose can be increased; usual maintenance dose is 5-10 mg 1 time per day. To determine the individual dose is best used tablets containing 2.5 mg of felodipine.
In elderly patients or patients with impaired liver function recommended initial dose of 2.5 mg 1 time per day.
stable angina pectoris
Adults: The dose is always determined individually.
The treatment starts with a dose of 5 mg 1 time per day, if necessary, the dose may be increased to 10 mg 1 time per day. The maximum daily dose is 20 mg 1 time per day.
Felodip drug may be used in combination with beta-blockers, angiotensin-converting enzyme (ACE) inhibitor or a diuretic.
Combination therapy usually enhances the hypotensive effect of the drug.
We need to guard against the development of arterial hypotension. In patients with severe hepatic impairment therapeutic dose should be reduced. In patients with impaired renal function The pharmacokinetics of the drug did not significantly change.
Information
Appearance may differ from that depicted in the picture. There are contraindications. You need to read the manual or consult with a specialist

Additional information

Weight0.100 kg
Manufacturer

TEVA

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