NifeHexal 30 La Sandoz tablets treat hypertension (3 blisters x 10 tablets)

Dosage form Box of 3 blisters x 10 tablets
Specifications Nifedipine

Ingredient

Composition information	Content
Nifedipine	30mg

Uses

Indications

Nifehexal 30 medicine is indicated in the following cases:

Treat all levels of hypertension. Calcium inhibitors reduce calcium ions passing through the membrane through a slow calcium channel into the cell. As an effective and selective calcium inhibitor, nifedipine acts mainly on the heart muscle and smooth muscle cells of coronary arteries and peripheral resistance vessels. The main effect of nifedipine is the artery smooth muscle relaxation, both permanent coronary and vascular. At the treatment dose, Nifedipine almost does not have a direct impact on the heart.

In hypertension, the main effect of nifedipine is to cause peripheral vessels, reducing peripheral resistance. In people with normal blood pressure, nifedipine does not or less effect on blood pressure. In angina, nifedipine reduces the resistance of coronary and peripheral vessels, leading to increased blood flow to the coronary artery, the supply of heart and the volume of each squeeze, while reducing the burden.

In addition, Nifedipine relaxes almost maximum of both the artery and does not have atherosclerosis, thereby protecting the heart against coronary spasm and improving perfusion for ischemia.

Increased heart rate reflexes and cardiac amounts that may occur at the beginning of treatment with calcium inhibitors. However, this increase is not enough to compensate for vasodilation.

When long -term treatment with nifedipine, the cardiac weight increases when starting treatment will return to the basic value. Clearly reducing blood pressure is recorded in patients with hypertension using Nifedipine. In Raynaud's syndrome, Nifedipine can prevent or reduce vascular spasms.

pharmacokinetic

absorption

Nifedipine oral is absorbed almost completely through the digestive tract. Nifedipine's oral bioavailability is 50 - 70% due to the initial metabolic effect. The peak concentration of plasma is achieved after 15 minutes when using a solution containing nifedipine and after 30-85 minutes when using nifedipine, fast release.

Distribution

About 95% Nifedipine binds to plasma proteins (albumin). The semi -destructive time after intravenous injection is determined for 5-6 minutes. The distribution volume is 0.6 - 1.2L/kg.

Metabolism

After drinking, Nifedipine is metabolized in the intestinal wall and in the liver, mainly due to oxidation. The metabolites are no longer active in pharmacological.

Elimination

With conventional forms of preparation, the semi -elimination time is 1.7 - 3.4 hours. Nifedipine is eliminated as its metabolites, mainly through the kidneys, about 5-15% excreted through the bile in the feces. Nifedipine has not metabolized can only be detected in urine in the form of traces (below 0.1%). When the liver and kidney function decrease, the clearance as well as the sale time of the drug will last.

Before taking NifeHexal 30 La Sandoz tablets treat hypertension (3 blisters x 10 tablets)

How to use

oral drugs. Take the whole pill with a cup of water, with or without food, do not bite, chew or crush the pill in any case. Nifedipine is long -acting should not be taken with grapefruit juice.

The drug needs to be taken at a distance of 24 hours, at the same time of the day, preferably drinking in the morning.

Dosage

In mild to moderate hypertension, the recommended starting dose is 1 tablet of 20mg x 1 time/day. In case of severe hypertension, the recommended starting dose is 1 tablet 30mg x 1 time/day. If necessary, the dose can be increased to 90mg x 1 time/day depending on the needs of each individual.

To prevent angina, the recommended starting dose is 1 tablet 30mg x 1 time/day. The dosage may increase up to 90mg x 1 time/day depending on the needs of each individual. Patients with hypertension or symptoms of angina are controlled by nifedipine or nifedipine capsules that can be safely converted to Nifedipine.

Preventive effectiveness is maintained when the patient transfers from other calcium inhibitors such as Diltiazem or Verapamil to Nifedipine for a long -lasting effect. Patients transferred from other calcium inhibitors should start treatment with the starting dose of 30mg of nifedipine that lasts once a day. The dose can then be then higher when the clinical indicators are guaranteed.

Used in combination with inhibitors or CYP3A4 inhibitors, recommend that nifedipine dose adjustment or nifedipine are required.

Treatment time

Treatment may continue indefinitely.

Children

Safety and effectiveness of nifedipine -acting effects in children under 18 have not been set up.

Elderly

No dose adjustment for patients over 65 years old.

Patients with renal failure

No dose adjustment.

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?

After indicating the stomach, if necessary, it can be combined with washing the small intestine.

Dialysis does not benefit because Nifedipine cannot be separated, but plasma extract may be recommended (high plasma protein binding, relatively low distribution integral).

Slow arrhythmia can be treated with symptoms of beta - sympathetic stimulants, and in life -threatening arrhythmias that threaten the recommended use of temporary pacemaker.

Hypotension caused by cardiac shock and arterial dilatation can be treated with calcium (slow venous injection of 10 - 20ml of 10% calcium gluconate solution and repeat if necessary). As a result, the amount of calcium in serum can reach the upper threshold of normal treatment to a slight increase. If the use of calcium is not enough to increase blood pressure, adding sympathetic drugs should be used such as dopamine or noradrenaline. The dosage of these drugs is determined based on the obtained efficiency.

Supplementing or compensating volume should be done carefully because the risk of the heart overload.

Especially in cases of nifedipine poisoning, slow -released formation, the removal of active ingredients should be completely as possible, including washing the small intestine, to prevent the absorption of active ingredients.

What to do when you forget a dose? However, if close to the next dose, skip the forgotten dose and take the next dose at the time as planned. Note that it should not be used double the prescribed dose.

Side Effects

When using NifeExal 30 LA, you may experience unwanted effects (ADR).

Common, ADR> 1/100

Neurological: headache.

blood vessels: edema, vasodilation. digestive: constipation.

Feeling unwell.

Uncommon, 1/1000

Immune: allergic reactions, allergic edema.

Mental: Anxiety, sleep disorders.

nerve: dizziness, migraine, dizziness, tremor. vision: visual disorders. Cardiovascular: tachycardia, chest drum, hypotension, fainting.

Respiratory: Nose bleeding, stuffy nose.

digestive: stomach pain, intestines, abdominal pain, nausea, indigestion, flatulence, dry mouth.

Liver: Increased liver enzymes.

Skin: Hong Ban.

Muscle and connective tissue: Cramps, joint swelling.

Kidney and urinary tract: Multi -urethra, urination.

Disorders of erectile dysfunction.

Non -specific pain, chills.

Rare, 1/10000

Immune: itching, urticaria, rash.

nervous: Perception, Perception. digestive: gum hyperplasia.

Not determined frequency

Blood: loss of granulocytes, leukopenia.

immunity: Anaphylaxis.

Neurological: weakness, drowsiness.

Hyperglycemia. vision: eye pain. Cardiovascular: chest pain (angina).

Respiratory: Difficulty breathing, pulmonary edema.

digestive: stomach objects, difficulty swallowing, intestinal obstruction, bowel ulcer, vomiting, poor spasm of stomach - esophagus.

Hepatoosa: jaundice.

Skin: Poisoned epidermal necrosis, allergic reactions to light, hemorrhage.

Bone muscle and connective tissue: joint pain, muscle pain.

Calmia syndrome.

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

Nifehexal 30 drug is contraindicated in the following cases:

Hypersensitivity to nifedipine or other dihydropyridine due to the theoretical risk of theoretical reaction, or any ingredient of the drug.

Cardiovascular shock, aortic stenosis of clinical significance, unstable angina or within 1 month after myocardial infarction.

Not used to treat acute angina.

Nifedipine's safety for prolonged prolonged hypertension has not been set.

Should not be used for secondary myocardial infarction.

Due to the duration of the dosage form, the long -lasting nifedipine should not be used for patients with liver failure.

Patients with a history of gastrointestinal obstruction, esophageal obstruction or reduced diameter of the digestive tract.

Patients with excess bags (formed after opening the ileum on the skin).

Patients with bowel disease or Crohn disease.

Should not be used with rifampicin because of the effective plasma concentration of nifedipine may not be achieved due to enzyme induction.

Be cautious when using

Caution in patients with very low blood pressure (severe hypotension with systolic blood pressure below 90mmHg), clear heart failure and severe aortic stenosis.

Nifedipine should not be used during pregnancy, unless clinical disease is needed to use nifedipine. Nifedipin should be provided to treat women with severe hypertension without responding to standard treatments.

Nifedipine is not recommended for breastfeeding because Nifedipine is excreted in breast milk and does not know the effect of absorbing a small amount of nifedipine by oral.

Nifedipine is needed to monitor Nifedipine with Magnesi Sulfate injected, because it can lead to excessive hypotension that can be harmful to both mother and fetus.

Patients with liver failure should be closely monitored, and in case of severe liver failure, may need to reduce the dose.

Nifedipine is metabolized through the Cytochrome P450 3A4 system. These inhibitors or induction of this enzyme system can change the initial transformation or clearance of nifedipine.

Active ingredients inhibitors of Cytochrome P450 3A4 systems can lead to increased nifedipine levels such as antibiotics macrolide group (erythromycin), protease inhibitors for HIV treatment (ritonavir), antifungal drugs Azole (ketoconazole), Nefazodone and fluoxetine, quinUketine/dalfopoPoProse Valproic, cimetidine. When used with the above drugs, blood pressure should be monitored and if necessary, nifedipine dose should be considered.

Should use other physical therapy methods when using nifedipine tablets that last for patients with severe digestive tract stenosis due to obstructive symptoms. Stomach foreign objects may appear in a rare number of cases and may need surgical intervention.

When conducting X -rays with contrast, the long -lasting nifedipine tablet can cause false positive effects (for example, filling the root of the defect that is interpreted as polyps).

The ability to drive and operate machinery

The reaction to the drug depends on each individual, which can affect the ability to drive and operate machinery. These are especially often occurring at the beginning of treatment, when changing the drug and when used with alcohol.

Recommendations when driving and operating machinery because the drug can cause unwanted effects (headache, dizziness) can affect the ability to drive and operate machinery.

Pregnancy

Do not use nifedipine during pregnancy unless the mother's clinical disease requires nifedipine treatment. Nifedipine should be provided to treat women with severe hypertension without responding to standard therapies.

In animal studies, Nifedipine shows the potential for embryo toxicity, fetal toxicity and teratogenic.

From the existing clinical evidence, the specific risks of pre -production have not been determined, although there is a report on hyperplasia, cesarean section as well as premature birth and growth retardation in the uterus. It is unclear whether the cause is caused by patients with hypertension or the treatment of hypertension, or the effect of a specific drug.

The acute pulmonary edema is recognized when calcium inhibitors, even other nifedipine drugs, are used as a premature birth drug during pregnancy, especially in the case of multicolyness (twins or more), when using intravenous injection and/or simultaneous use with Beta - 2.

breastfeeding period

nifedipine is excreted into breast milk. Nifedipine concentration in milk is almost equivalent to the concentration of the mother's serum. For immediate release, breastfeeding or milking for 3-4 hours after taking the drug to reduce the likelihood of Nifedipine exposure to the baby.

Drug interaction

nifedipine is metabolized by the Cytochrome P450 3A4 system, located on both the liver and intestinal mucosa. Therefore, these enzyme inhibitors or activation can change the initial metabolism (after drinking) or change the clearance of nifedipine. The level and time of interaction should be evaluated when using nifedipine with the following drugs:

Rifampicin: Rifampicin strong touch CYP3A4. When simultaneously used with rifampicin, nifedipine's bioavailability decreases significantly, resulting in reduced effectiveness of the drug. Therefore, contraindicated use simultaneously nifedipine and rifampicin.

When combined with weak to medications from weak to medium CYP3A4, blood pressure should be monitored. If necessary, consider reducing the dose of nifedipine.

Macrolide antibiotics (erythromycin): There has been no interaction research between nifedipine and macrolide antibiotics. Macrolide antibiotics inhibit metabolites through CYP3A4 intermediaries of other drugs. Therefore, the risk of increasing plasma concentrations in nifedipine cannot be excluded when used simultaneously these two drugs. Azithromycin, although belonging to the macrolide antibiotic group, does not inhibit CYP3A4.

Ritonavir inhibitors (Ritonavir): There is no clinical research to assess the risk of interaction between Nifedipine and HIV -treatment protease inhibitors. The drugs in this group inhibit the Cytochrome P450 system. When taken simultaneously with Nifedipine, it is not possible to eliminate the significant increase in bioavailability of Nifedipine due to initial decrease.

Fluoxetine: There is no clinical research on the risk of drug interaction between Nifedipine and Fluoxetine. Fluoxetine shows the inhibitory effect of in vitro with Nifedipine's intermediate metabolism. Therefore, it is not possible to rule out the possibility of increased nifedipine levels in plasma when using these two drugs.

Nefazodone: There is no clinical research on the risk of drug interaction between Nifedipine and Nefazodone. Nefazodone shows the effect of inhibiting intermediate metabolites of CYP3A4 of other drugs. Therefore, it does not exclude the possibility of increased nifedipine concentration in plasma when used simultaneously these two drugs.

quinuprristin/dalfopristin: simultaneous use of Quinuprristin/Dalfopristin and Nifedipine can lead to increased plasma concentrations of nifedipine.

Valproic acid: There has been no official research on the risk of interaction between nifedipine and Valproic acid. Because Valproic acid shows increased plasma concentrations of nimodipine (calcium inhibitors with similar structure) due to enzyme inhibition, it is not possible to eliminate the increase in plasma nifedipine levels leading to increased effect.

cimetidine: Due to CIMETIDINE inhibits CYP3A4, increasing plasma concentrations of nifedipine and can increase hypotension.

cisapride: Used with nifedipine may increase the concentration of nifedipine.

CYP3A4 anti -epilepsy drugs (Phenytoin, carbamazepine, phenobarbital): When used simultaneously with phenytoin, nifedipine's bioavailability is reduced, so the effectiveness of the drug is reduced. When both drugs are used simultaneously, the clinical response to nifedipine should be monitored, if necessary, consider increasing the dose of Nifedipine. If the dose of nifedipine increases during simultaneous use of 2 drugs, it is recommended to reduce the dose of nifedipine when stopping phenytoin. Because carbamazepine and phenobarbital both reduce the concentration of nimodipine (calcium inhibitors with similar structures) due to enzyme induction, so it is not possible to eliminate concentration and reduce the effectiveness of nifedipine.

Nifedipine may increase the effect of lowering blood pressure when used with medications for hypertension such as diuretics, beta inhibitors, ACE inhibitors, Angiotensin II receptor inhibitors (AT1), other calcium inhibitors, Alpha - Adrenergic inhibitors, PDE5 inhibitors, Alpha - Methyldopa. It is necessary to monitor patients carefully when using Nifedipine simultaneously with beta inhibitors, because the heart failure progresses worse in some special cases.

Digoxin: Concomitant use of nifedipine and digoxin can lead to reducing digoxin clearance, increasing the serum concentration of digoxin. Therefore, patients should be carefully checked for symptoms of digoxin overdose. If necessary, the reduction of glycoside dose should be conducted based on serum Digoxin concentration.

quinidine: When using simultaneously nifedipine and quinidine, the quinidine concentration is low, or after stopping using nifedipine, in a few cases observed the significant increase in quinidine concentration in plasma. For this reason, when starting or stopping nifedipine, recommends monitoring of quinidine concentration in plasma and adjusting the quinidine dose if necessary. Blood pressure monitor should be carefully monitored, if quinidine is used while using nifedipine. If necessary, nifedipine dose should be reduced.

tacrolimus: Tacrolimus has been shown to be metabolized through CYP3A4. When using two drugs simultaneously, the plasma concentration of Tacrolimus should be monitored, if necessary, consider reducing the dose of Tacrolimus.

grapefruit juice inhibits CYP3A4. Nifedipine simultaneous use with grapefruit juice can increase plasma concentrations and prolong the effect of nifedipine due to reducing initial metabolism or reducing clearance. Hypotension effects may increase. Therefore, avoid using grapefruit/grapefruit juice while using nifedipine.

Storage

Store under 30ºC. Keep medicine in packaging.

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