Nifedipin Hasan 20 Retard Hasan tablet treatment for hypertension (10 blisters x 10 tablets)

Dosage form Box of 10 blisters x 10 tablets
Specifications Nifedipine

Ingredient

Composition information	Content
Nifedipine	20mg

Uses

indications

Nifedipin Hasan 20mg is indicated in the following cases:

Preventive preventive chronic angina.

Treatment hypertension .

Pharmacology

Nifedipin is a strong and selective antagonist drug in group 1.4 - dihydropyridine. Calcium antagonists reduce calcium ions through cell membranes through calcium channels slowly entering the cell.

Nifedipine has a special impact on myocardial alert, coronary muscle cells and peripheral resistance capillaries. The main impact of nifedipine relaxes the artery smooth muscles, in both coronary and peripheral blood vessels.

In patients with hypertension, the main effect of Nifedipine is to relax the peripheral vessel, thereby reducing peripheral resistance.

In patients with angina, nifedipine reduces peripheral resistance and coronary resistance, increases blood flow to coronary artery, cardiac weight and blood pump volume, post -load.

In addition, Nifedipin dilates the maximum of the maximum level in patients with or without atherosclerosis rims, thus protecting the heart from coronary spasms and increasing blood flow to ischemic heart muscle.

Nifedipine reduces the likelihood of heart attacks and electrocardiogram changes (ECG) due to ischemic, regardless of cases of coronary artery spasms or atherosclerosis.

Nifedipin Hasan 20mg is used 2 times/day, bringing control of blood pressure for 24 hours. Nifedipin Hasan 20mg causes blood pressure reduction effect with direct influence depending on the first dose. In normal people, Nifedipin Hasan 20 Retard has little impact or no impact on blood pressure.

EM: Nifedipin comparison data patches other anti -hypertension drugs in acute or chronic hypertension with different forms of preparation and doses. Nifedipine's anti -hypertension effect has been shown but the dose, safety and long -term effectiveness on the heart have not been studied. No preparation for children.

Dynamic pharmacokinetics

absorption

After drinking, Nifedipin is absorbed quickly and almost completely. The full bioavailability of nifedipine is 45 - 56%, due to the first metabolic effect. The maximum concentration in serum and plasma is reached from 1.5 to 4.2 hours. Food slows down but does not reduce absorption.

distribution

95% nifedipine binds to plasma proteins (albumin). Half life distribution of drugs after intravenous injection is about 5-6 minutes.

transformation

After drinking, Nifedipine is metabolized in the intestinal and liver wall, mainly by oxidative reactions. Metabolic substances with non -pharmacological activity.

Elimination

Nifedipin is eliminated in the form of chemicals mainly through the kidneys and about 5-15% through biliary tract released to feces.

Non -metabolic substances are found in the form of traces (below 0.1%) in urine. The sale time of the drug is from 6 to 11 hours, because the drug is slowly absorbed. There is no report on the accumulation of drugs at the usual dose during long -term treatment. In patients with renal failure, it is not necessary to adjust the dose compared to healthy people.

pharmacokinetics in some special clinical subjects

Hepatic failure:

In a pharmacokinetic comparative study in patients with mild hepatic impairment (Child-Pugh a) or medium (Child-Pugh B) compared to those with normal liver function, Nifedipine clearance orally decreased by 48% (Child-Pugh a) and 72% (Child-Pugh B).

AUC and an average increase of 93% (Child-Pugh A) compared to 64% in people with normal liver function, and 253% (Child-Pugh B) compared to 171% in people with normal liver function.Nifedipin's

pharmacokinetics is not studied in serious liver failure patients.

Before taking Nifedipin Hasan 20 Retard Hasan tablet treatment for hypertension (10 blisters x 10 tablets)

How to use

Nifedipin Hasan 20mg Tablets are used for orally.

Take whole pills with water, or not with food.

Do not share Nifedipin Hasan 20mg with grapefruit juice.

Dosage

The recommended dose of Nifedipin Hasan 20 Retard is 10 mg every 12 hours, then adjust the dose depending on the response. Nifedipin Hasan 20 Retard allows the initial dose adjustment, 40mg every 12 hours to a maximum dose of 80 mg per day.

Nifedipin Hasan 20 Retard is used with inhibitors or CYP 3A4 inhibitors or induction may need dose or stop use of Nifedipin.

Vernateal for prolonged treatment with Nifedipin Hasan 20 Retard.

Dosage in special clinical objects:

Children: The safety and effectiveness of Nifedipin Hasan 20 Retard in children under 18 have not been set up.

Elderly patients (> 65 years old): Nifedipin Hasan 20 Retard in the elderly changes. Therefore, Nifedipin's maintenance is required.

Patients with liver failure: Nifedipine is metabolized by the liver. Therefore, patients with mild, medium or serious liver dysfunction should be monitored and reduced if necessary.

Patients with renal failure: According to pharmacokinetic data, no dose adjustment in patients renal failure .

Note: The above dose is for reference only. Specific dosage depends on the condition and level of progression of the disease. For a suitable dose, you need to consult a doctor or medical specialist.

What to do when overdose?

Symptoms:

Loss of consciousness leads to coma, hypotension, tachycardia, slow heart rate, hyperglycemia, metabolic acidosis, reducing blood oxygen, cardiac shock with pulmonary edema.

How to handle:

When overdose, first need to remove nifedipine and stabilize cardiovascular. Nifedipine removal as much as possible, including in the small intestine to prevent the absorption of active pharmaceutical substances.

Benefits of some measures to eliminate smoking from the stomach uncertainty:

Use activated carbon (50 g for adults, 1 g/kg for children) for patients who take an overdose within 1 hour earlier. This is consistent with the assumption that activated carbon will be useful in the case of prolonged release but no evidence.

Gastric lavage for adults within 1 hour after severe overdose is life -threatening.

If the patient uses a prolonged release drug with a penetrating laxative, consider using activated carbon every 4 hours later.

When the patient has no overdose symptoms, it is necessary to monitor for 4 hours after taken and 12 hours for prolonged release drugs.

Hemolysis does not work because nifedipine cannot be appraised, but the plasma filtering method is recommended (high plasma protein concentrations, relatively low distribution integral).

Hypotension caused by cardiac shock and arterial dilatation can be treated with calcium (10 - 20 ml of 10% calcium gluconate solution intravenously within 5 - 10 minutes). If the effect is incomplete, continue to monitor the electrocardiogram. If there has not been a hypertension by calcium, use sympathetic vasoconstrictions such as dopamine or noradrenalin. Dosage depends on the patient's response.

Symptoms of bradycardia can be treated with atropin, beta sympathetic or temporary pacemaker.

To avoid heart overload, careful infusion.

What to do when forgetting 1 dose? Do not take double dose to compensate for the forgotten dose.

Side Effects

When using Nifedipin Hasan 20mg, you may experience unwanted effects (ADR).

Common, ADR> 1/100

Systemic: Feeling unwell.

Neurological: headache .

blood vessels: edema, vasodilation.

digestive: constipation .

rarely, 1/1000

Systemic: unexplained pain, chills.

Immune: allergies, eagles, including larynx edema.

Mental: Anxiety, sleep disorders.

Neurology: dizziness, dizziness, migraine, tremor.

Eye: visual disorders.

Heart: Heart quickly, brushing the chest.

blood vessels: lower blood pressure, fainting.

Respiratory: Nasal congestion, nosebleeds .

Digestive: abdominal pain, nausea, flatulence, indigestion, fullness, dry mouth.

Liver: Temporary liver enzyme.

Skin, subcutaneous tissue: Red skin.

muscle, bone, connective tissue: cramps, swelling.

Kidney and urinary tract: polyurges, anuria.

Reproductive system: erectile dysfunction.

rare, 1/10,000

Immune: itching, urticaria, rash.

Neurological: Perception, loss of sensation.

Gastrointestinal: gum hyperplasia.

Unknown frequency

Blood, lymphatic system: Losing leukocytes, leukopenia.

Immune: Anaphylactic reaction.

Metabolism and nutrition: Hyperglycemia.

Neurological: reducing sensation, drowsiness.

Eyes: eye pain.

Heart: angina.

Respiratory: Difficulty breathing, pulmonary edema.

Gastrointestinal: Vomiting, stomach muscles - esophagus.

Liver: jaundice.

Skin, subcutaneous tissue: Dermatitis from poisoning, sensitive to light, bleeding under the skin.

muscle, bone, connective tissue: joint pain, muscle pain.

Instructions on how to handle ADR

When experiencing side effects of the drug, it is necessary to stop using and notify the doctor or go to the nearest medical facility for timely treatment.

Warnings

Before using the drug you need to read the instructions carefully and refer to the information below.

contraindicated

nifedipin hasan 20mg contraindicated in the following cases:

hypersensitivity to nifedipine, drugs of the dihydropyridine group (due to the risk of cross allergy), or hypersensitivity to any component of the drug.

Heart shock, significant aortic stenosis, unstable angina or within 4 weeks after myocardial infarction.

Acute angina.

Malignant hypertension (due to unsafe safety).

Secondary prevention for myocardial infarction.

Coordinate with rifampicin (because plasma nifedipine concentration does not reach the effective threshold due to enzyme impact).

Be cautious when using

nifedipin hasan 20 retard does not block the beta receptor, so there is no reaction due to sudden beta blocking.

Nifedipin Hasan 20 Retard can be combined with beta blockers and other hypertension drugs but pay attention to the risk of posture hypotension. Nifedipin Hasan 20 Retard does not prevent the backward effect when discontinuing other hypertension medications.

Be cautious in patients with low blood pressure (serious hypotension with systolic blood pressure

In patients with mild, moderate or serious impaired liver function, need to monitor and adjust the dose if needed. Nifedipine pharmacokinetics have not been studied in serious liver failure patients. Therefore, careful use of nifedipine in these patients.

Use Nifedipin Hasan 20 Retard carefully in patients with loss of heart failure. Nifedipine can make the heart failure worsen.

may need to adjust the dose of Nifedipin Hasan 20 Retard in diabetes patients.

In patients who are hematoma with malignant hypertension and decrease in circulatory volume may occur significantly.

Nifedipin is metabolized through the CYP P450 3A4 system. These inhibitors or enzyme inhibitors may change the first time or the clearance of nifedipine.

CYP P450 3A4 inhibitors increase Nifedipin levels including:

Macrolid antibiotics (erythromycin).

Ritonavir inhibitors (Ritonavir).

Azol antifungal drugs (ketoconazol).

anti -agarwood (nefazodon and fluoxetin).

quinuprristin/ dalfopristin.

Valproic acid.

cimetidin.

When combined with the above drugs, need to monitor blood pressure and reduce the dose of nifedipine if needed.

Preparations contain lactose Monohydrate excipients. Patients with rare genetic problems in tolerance Galactose, Lapp lactase enzyme deficiency or Glucose - Galactose should not use this drug.

The ability to drive and operate machinery

The reactions of the drug changes a lot between different patients, but reduces the ability to drive and operate machinery. This usually occurs in the early stages of treatment, when adjusting the dose or used with alcoholic drinks.

Pregnancy

Do not use Nifedipin Hasan 20 Retard for pregnant women unless necessary.

Animal research shows that nifedipine toxicity to the fetus and teratogenic. There is no complete research on pregnant women.

Clinical evidence does not determine the risk during pregnancy, although there is an increase in asphyxiation, need for caesarean section, premature birth and fetal retardation. It is not clear that the cause comes from hypertension, due to the treatment or the special effect of the drug.

The above information is not enough to eliminate harmful reactions for children in the womb or newborn. Therefore, it is necessary to assess the risk and benefit carefully before taking drugs in pregnant women, only when other treatments are not suitable or ineffective.

Acute pulmonary disease can occur when taking calcium blockers, as well as other nifedipin drugs that are the anti -uterine contractions during pregnancy, especially in twins or more. The drug can be used for injection and/ or in combination with Beta-2.

The period of breastfeeding

nifedipin is excreted in milk. Nifedipine concentration in milk is close to the mother's serum concentration. For instantaneous relations, breastfeeding or breast pump after 3-4 hours of taking medication to minimize nifedipine exposure to infants.

Drug interaction

nifedipin metabolizes through the CYP P450 3A4 enzyme found in the liver and intestinal mucosa. The drugs are quite inhibited or the enzyme system can change the first time (after drinking) or change the clearance of nifedipine:

rifampicin : Rifampicin strong touch enzyme CYP P450. When used with rifampicin, nifedipine's bioavailability decreases significantly and the effects of the drug weaken. Anti -expenses shared nifedipine and rifampicin.

CYP P450 3A4 inhibitors: Nifedipine dose monitoring and dose reduction if necessary.

Nifedipine levels such as macrolid antibiotics (erythromycin), HIV anti -HIV inhibitors (ritonavir), antifungal group Azol (ketoconazol), nefazodon, fluoxetin, quinuprristin/dalfopristin, cisaprid, valproic acid, cimetidin, daletidine

CYP P450 3A4 induction drugs: Nifedipine clinical response should be monitored and dose increased if necessary. When increasing nifedipine dose during coordination with other drugs, nifedipine dose should be considered when the drug is discontinued. Nifedipin levels such as rifampicin, phenytoin, carbamazepin, phenobarbital.

Nifedipin's impact on other drugs:

Other blood pressure drugs: increase hypotension when combined with nifedipine.

Beta blockers: Need to monitor closely because heart failure is so bad in some cases.

Digoxin: Coordinate with nifedipin can reduce the clearance of digoxin, and thus increase the concentration of digoxin in plasma. Patients should be tested for symptoms of digoxin overdose and glycosides if necessary.

quinidine: Coordinating with nifedipine can reduce quinidine levels. After stopping using nifedipine, in some cases, quinidine concentration increases significantly. Therefore, when coordinating or stopping nifedipine, it is necessary to monitor the quinidine concentration in plasma and adjust the dose if necessary. Nifedipine dose is needed to monitor and reduce the dose of nifedipine if needed.

tacrolimus: Tacrolimus is metabolized through CYP P450 3A4. Research data shows that in some cases, Tacrolimus should be reduced when used in combination. Therefore, it is necessary to monitor the concentration of tacrolimus and reduce the dose if necessary.

Grapefruit juice cluster: Inhibit CYP P450 3A4 enzyme. Sharing beam grapefruit juice and nifedipine increases the concentration and prolongs the impact time of nifedipine (due to reducing metabolism for the first time or reducing the bars), increasing the hypotension effect of nifedipine. After drinking grapefruit juice, the effect lasts for 3 days. Avoid using grapefruit/ grapefruit juice while being treated with nifedipine.

Other interactions: Nifedipine can increase the spectral data of vanillyl mandelic acid in urine. However, the method of measurement in HPLC is not affected.

Storage

In dry place, below 30C. Avoid light.

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