Plendil Plus Astrazeneca tablets for hypertension (30 tablets)

Dosage form Box of 30 tablets
Specifications Felodipine, Metoprolol

Ingredient

Composition information	Content
Felodipine	5mg
Metoprolol	47.5mg

Uses

Indications

Plendil Plus drug is indicated for hypertension .

Plendil Plus can be used when mono -treatment with β blockers or calcium antagonists in the group dihydropyridine is ineffective.

Pharmacokology

Plendil Plus is a preparation to treat hypertension, combining felodipine, calcium antagonistic drugs that have a selective effect on peripheral blood vessels and metoprolol, selective blockers of receptors β1.

Due to the mechanism of impact of these two active ingredients ( felodipine reduces foreign resistance and Metoprolol reduces cardiac flow), the drug has a more significant treatment for hypertension than when using separate treatment for each drug.

Plendil Plus gives a stable and effective impact of reducing blood pressure during the period between 2 doses (24 hours).

felodipine

Felodipine is a selective calcium channel blocker on blood vessels, used in the treatment of hypertension and stable angina.

Felodipin is the derivative of dihydropyridine and is racemic.

Felodipine reduces peripheral blood vessel resistance, especially on artery. The voltage and spasms in blood vessel muscle cells are inhibited through the impact on calcium channels in the cell membrane. Therefore, Felodipine has a selective effect on the artery smooth muscle, in the doses of drug treatment that does not inhibit myocardial contraction and has no physiological impact on the heart significantly.

Felodipin relaxes the respiratory smooth muscles. Clinical experience shows that felodipine has little effect on the ability to exercise stomach - intestines. Not recorded felodipine has any significant clinical effects on blood lipid values when taking the drug for a long time. There is also no significant clinical impact on metabolic control (HBA1C) in patients with type 2 diabetes during 6 months of treatment.

In general, Felodipine can be used for patients to reduce left ventricular function, those who have been treated with conventional therapy and can be used for asthma, diabetes, gout or hyperlipidemia.

Hemorrhage treatment: Felodipine arterial hypotension due to hypoglycemia. Felodipine treatment in patients with hypertension lower blood pressure lying, sitting and standing, resting as well as exertion.

Felodipine does not cause hypotension because the drug does not affect venous muscles or the mechanism of controlling the sympathetic system. A decrease in blood pressure may increase the heart rate and transient reflex heart flow. Increased heart rate can be neutralized if used combined with felodipine with β blockers. The impact on blood pressure and the entire peripheral resistance is correlated with felodipine levels in plasma.

In a stable state, the drug has a long -lasting effect between two doses and reduces blood pressure during 24 hours.

Treatment with felodipine causes left ventricular hypertrophy.

Felodipine has the effect of sodium and diuretic but does not have the effect of potassium. The drug reduces the sodium and water absorption load through the renal tubules, which can explain the non -fluid and salt in the patient.

Felodipine reduces kidney blood vessel resistance and increases kidney perfusion. Does not affect the filtration of the glomerular.

Felodipin does not affect the excretion of albumin.

metoprolol

Metoprolol is an β1 sympathetic inhibitor, which means that the effect on the receptor β1 in the heart is much lower than the dose needed to have the effect on the receptor β2 present on the peripheral blood vessels and bronchi.

Metoprolol has no stimulating effect β endogenous and very little stimulating effects on cell membranes.

receptor blockers β have the effect of inhibiting myocardial and myocardial muscle contraction.

Metoprolol treatment reduces the effects of catecholamine related to physical and mental stress, causing heart rate slow, reducing heart flow and lowering blood pressure.

During stress accompanied by adrenalin secretion from the adrenal gland, metoprolol does not prevent normal physiological vasodilation.

In the treatment doses, Metoprolol has little spasms on the bronchial muscle system compared to the non -selective β blockers. This feature makes Metoprolol can be used in patients with bronchial asthma or have obstructed pulmonary disease when combined with receptor stimulants β2.

Metoprolol has little effect on insulin secretion and carbohydrate metabolism compared to non -selective β blockers, and thus can be used for diabetics.

Metoprolol's cardiovascular effects when hypoglycemia, such as tachycardia, is lower and blood sugar levels return to normal values that occur faster than when using unsatisfactory receptor blockers β.

For patients with hypertension, Metoprolol reduces blood pressure in both lying and standing and exertion. At the beginning of treatment with Metoprolol, it increases peripheral circuit resistance. However, when used for a long time, the impact of hypotension is thought to be due to reducing peripheral pulse and not changing the heart flow.

Metoprolol reduces the risk of cardiovascular death on average/severe hypertension.

No electrolyte average disorder occurs.

pharmacokinetics

felodipin

Biowear is about 15% and is not affected by food. Shared food affects the absorption rate, does not affect the level of absorption, showing why the maximum concentration in plasma increases to about 65%.

Peak concentration in plasma reaches after 3-5 hours. The cohesion with the plasma protein of felodipine is approximately 99%.

The distribution volume in a stable state is 10l/kg. Felodipine's exhaust time in the disposal phase is about 25 hours and the stable state reaches after 5 days. There is no risk of accumulating drugs during long -term treatment.

The average clearance is 1200ml/min. The clearance in the elderly and patients with impaired liver function, increasing felodipine levels in plasma in these patients compared to young patients. However, age only explains the difference in the drug concentration in plasma between individuals.

felodipine metabolized through the liver by Cytochrom P450 3A4 (CYP3A4) and possible metabolic substances that are not active in vasodilation.

About 70% of the dose is excreted in the form of metabolism in urine, the rest is excreted in feces. Less than 0.5% of the dose is excreted in a constant form in the urine.

impaired renal function does not affect the concentration of felodipine in plasma, but the accumulation of inactive metabolites. Felodipine is not eliminated by blood decomposition.

metoprolol

The active ingredient is completely absorbed after drinking through the entire digestive tract, including the colon. Biological comfort is 30-40%.

metoprolol metabolizes in the liver, mainly through CYP2D6. Aware of 3 main metabolites, but no substance has a significant β inhibitor effect.

About 5% of the dose is excreted in the form of unchanged, the rest of the dose is excreted in the form of metabolites.

Characteristics of combined preparations

Use Plendil Plus does not change the bioavailability of Metoprolol or Felodipine compared to when using two felodipine and metoprolol preparations simultaneously. The absorption is not affected by food.

Before taking Plendil Plus Astrazeneca tablets for hypertension (30 tablets)

How to use

Plendil Plus medicine is used orally.

Executive release should be used once a day in the morning. The drug must be swallowed with liquids, not to be broken, crushed or chewed. Prolonged release can be taken when hungry or with low -fat snacks and carbohydrates.

Dosage

Dosage changes for individuals. The starting dose is based on the previous treatment experience with β blockers or calcium antagonists.

Adults

A long -lasting release plentil plus 5/50mg per day. If necessary, the dose may increase to two plentil plus long -lasting relics every day.

Patients with kidney damage

Kidney function damage does not affect the concentration of drugs in plasma. No dose adjustment.

Patients with liver function damage

No need to adjust the dose in patients with cirrhosis because Metoprolol has a low protein binding (5 - 10%). If there are signs of very severe liver function damage (for example, patients who have surgery to have a venous dynamic surgery), do not use higher doses of more than 1 PLENDIL Plus tablet.

Elderly

1 LACK LACK PLENDIL Plus, 1 time/day is usually enough. When necessary, the dose may increase to 2 long -lasting release plans every day.

Children

Due to the lack of clinical data, Plendil Plus should not be used for children.

Advice when taking drugs

Avoid sudden use of medication. If possible, the dosage reduction mode should be done and/or indicated every Monday in every 10-14 days. In particular, during this period, it is necessary to closely monitor in patients who know that there is ischemic condition because the risk of myocardial infarction and sudden death may increase when stopping using Plendil Plus or pharmaceuticals containing other β blockers.

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

Symptoms of overdose may include hypotension, heart failure, heart rate and arrhythmia, heart disease disorders, vascular resistance and bronchospasm.

Handling

Patients need to be cared for at a facility that can provide appropriate support, control and monitoring measures.

If necessary, you can use activated carbon and/or gastric lavage.

Atropin , Adreno stimulants or heartbenting machines are used to treat slow heart rate and conduction disorders.

Hypotension, heart failure acute and shock should be treated by transmitting appropriate quantities, glucagon injection (if necessary, then glucagon intravenous infusion), intravenous infusion Adreno stimulants such as dobutamin with Alpha-1 anti-receptive drugs when there is vasodilation. Can consider the use of intravenous Ca2+.

Bronchospasm is usually recovered with bronchodilators.

What to do when forgetting a dose?

Side Effects

When using Plendil Plus , you may experience unwanted effects (ADR).

Plendil Plus is well tolerated and usually mild and recovered adverse reactions.

The most unwanted effect is recognized in clinical trials with Plendil Plus is headache, ankle edema and blushing, dizziness, nausea, fatigue. Most of these effects are due to Felodipine vasodilation properties, which often depend on the dose and appear at the beginning of treatment or when increasing the dose. If there are appears, the symptoms often temporarily and gradually decrease over time.

felodipin

Very common, ADR> 1/10

General and on -site disorders: peripheral edema.

Common: 1/100

Nervous system disorders: headache .

Vascular disorders: Flush.

General and on -site disorders: fatigue.

Uncommon, 1/1000

Disorders of the nervous system: dizziness, paresthesia.

Cardiovascular disorders: Brushing chest drum, tachycardia.

Vascular disorders: hypotension (hypotension).

Skin and tissue disorders: rashes.

Digestive disorders: Nausea, abdominal pain.

Rare, 1/10000

Vascular disorders: fainting.

Skin and subcutaneous tissue disorders: rash urticaria .

Digestive disorders: vomiting.

musculoskeletal and connective tissue disorders: joint pain, muscle pain.

Reproductive and mammary disorders: helpless/sexual disorders.

Very rare, ADR

Digestive disorders: swelling of gums, gingivitis.

Skin and subcutaneous tissue disorders: Reaction sensitive to light, vascular inflammation too hypersensitivity.

Hepatic liver disorders: Hyper enzyme.

Kidney and urinary disorders: urinating.

General and on -site disorders: Hypersensitivity reactions such as angioedema, fever.

metoprolol

Very common, ADR> 1/10

General and on -site disorders: fatigue.

Common, 1/100

Nervous system disorders: dizziness, headache.

Cardiovascular disorders: slow heart rate, chest drum.

Blood vessel disorders: posture disorders (very rare accompanied by fainting hands and feet.

Digestive disorders: Nausea, abdominal pain, diarrhea, constipation .

Respiratory disorders, chest and mediastinum: Difficulty breathing.

Uncommon, 1/1000

Nervous system disorders: Perception.

Mental disorders: depression, concentration, drowsy nightmares or insomnia.

Cardiovascular disorders: Symptoms of heart failure, Heart 1, edema, epigastric pain. gastrointestinal disorders: vomiting.

Respiratory, chest and medical disorders: Spasms during exertion.

Skin and subcutaneous tissue disorders: skin rash (urticaria, psoriasis and skin damage due to nourishment), sweating a lot.

Musculoskeletal and connective tissue disorders: cramps.

Metabolic and nutritional disorders: weight gain.

General and on -site disorders: edema.

Rare, 1/10000

Mental disorders: suspense, anxiety.

Cardiovascular disorders: arrhythmia, conduction disorders.

Digestive disorders: dry mouth.

Liver system disorders: abnormalities on liver function tests.

Disorders of skin and subcutaneous tissue: Hair loss .

Respiratory, chest and medical disorders: rhinitis.

eye disorders: visual disorders, dryness and/or eye irritation, conjunctivitis.

Reproductive and mammary disorders: helpless/sexual disorders.

Very rare, ADR

Nervous system disorders: taste disorders.

Mental disorders: forget/impaired memory, disorders, hallucinations.

Bloody system disorders: necrosis when patients with severe peripheral circulatory disorders.

Ear disorders and the vestibular system: tinnitus .

Skin and subcutaneous tissue disorders: sensitive to light, more severe psoriasis.

Disorders of blood system and lymph: platelets.

Hepatitis: Hepatitis.

musculoskeletal and connective tissue disorders: joint pain.

Instructions on how to handle ADR

Notify the doctor with unwanted effects when using the drug.

Warnings

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

Contraindicated

Plendil Plus drug contraindicated in the following cases:

Knowing hypersensitivity to any component of other drugs or other dihydropyridine or β inhibitors.

Pregnant women.

Unstable angina. β.

Precautions when used

Felodipine and metoprolol combination forms can cause blood pressure drops like other hypertension medications. Can lead to myocardial anemia in sensitive patients.

In the case of a patient with bronchial asthma, it is necessary to treat appropriate bronchodilators (tablets or inhaled lines). The dose of stimulants may be needed at the beginning of treatment with Plendil Plus. However, the risk of interaction between Plendil Plus and the β2 athlete is still lower than the usual forms of selective β1 blockers.

Treatment with Plendil Plus may affect carbohydrate metabolism or cover the signs of hypoglycemia, but the risk is lower than the usual forms of selective β1 blockers and much lower than the non -selective β blockers.

Do not use Plendil Plus for patients with hidden or clear heart failure without using the heart failure.

Atrial - ventricular disorders that have been worse may be worse (which can lead to obstruction of the atrial transmission).

Caution should specify Plendil Plus in patients with serious metabolic acidosis. In patients treated with Plendil Plus, do not use calcium antagonists of intravenous verapamil.

If the heart rate condition progresses significantly, it is necessary to reduce the dose of Plendil Plus or take the drug gradually. Plendil Plus may increase symptoms or aggravate symptoms of peripheral artery circulation.

Avoid the combination of Plendil Plus combination with strong CYP3A4 inhibitors and touch. Strict control requirements on treatment and frequency of adverse events when coordinated with strong CYP3A4 inhibitors and touch (see drug interaction).

When using Plendil Plus in patients with chrome cell tumors, it is advisable to consider using Alpha receptor inhibitors.

Before surgery, anesthetic doctor must be notified that the patient is using Plendil Plus. Do not stop treating with β blockers in patients undergoing surgery.

Use β blockers can make the treatment of anaphylactic reaction more difficult. Adrenalin treatment in normal doses is not always for the desired therapeutic effect.

Should be carefully used β1 blockers selected in patients with prinzmetal angina.

Mild gum hypertrophy has been reported in patients with gingivitis/dental inflammation. Agency can be avoided or recovered by careful oral hygiene.

Plendil Plus contains lactose and should not be used for patients with poorly absorbent Galactose or Glucose-Galactose.

The ability to drive and operate machinery

Due to dizziness and fatigue can occur when treated with Plendil Plus, this should be special when patients need to be alert as driving or operating the machine. Patients must self -assess the level of alertness when using Plendil Plus.

Pregnancy

Do not use Plendil Plus during pregnancy.

Breastfeeding period

Felodipine is secreted into breast milk. Using the drug in the treatment dose for breastfeeding mother does not affect the emulsion.

β blockers can cause unwanted effects such as fetal bradycardia, infants and breastfed babies. However, the amount of Metoprolol absorbed through breast milk does not seem to cause significant β blockers in children if the mother is appointed to use Metaprolol in the treatment dose.

Drug interaction

Use simultaneously with substances that affect the cytochrom P450 enzyme system that can change the plasma concentration of both felodipine and metoprolol.

Felodipine and Metoprolol do not interact with each other because they use different isomers of the enamel system Cytochrom P450.

Interaction with felodipine

Felodipine is metabolized by the liver by Cytochrome P450 3A4 (CYP3A4). Felodipine is CYP3A4. CYP3A4 inhibitors or enzyme drugs significantly affect felodipine levels in plasma.

Interaction leads to increased felodipine levels in plasma

CYP3A4 inhibitors have shown increased felodipine levels in plasma and should avoid treatment in combination with a powerful CYP3A4 inhibitor. Example:

Strong CYP3A4 inhibitors:

Itraconazole;

ketoconazole;

Other CYP3A4 inhibitors:

cimetidin;

erythromycin;

When used at the same time as ITRACONAZOL, Felodipine's CMAX increased by 8 times and AUC increased by 6 times. When used simultaneously with erythromycin, cmax and auc of felodipine increased by 2.5 times.

When used at the same time as grapefruit juice, cmax and AUC of Felodipine increases about 2 times. When used at the same time as cimetidine, cmax and AUC of Felodipine increased by about 55%.

Interaction leads to reduced plasma concentrations of Felodipine

CYP3A4 induction substances have shown to reduce felodipine levels in plasma and should avoid using strong CYP3A4 induction. Example:

phenytoin;

carbamazepin ;

rifampicin; World).

Concentrated with carbamazepin, phenytoin and phenobarbital, felodipine AUC decreased by 93% and CMAX decreased by 82%.

Other felodipine interactions

tacrolimus: Felodipine may increase the concentration of tacrolimus. When used simultaneously, the tacrolimus concentration must be monitored and may need to adjust the tacrolimus dose.

cyclosporin: When concurrent use of cyclosporin and felodipine, Felodipin's cmax increases by 150% and AUC increases by about 60%. However, felodipine does not affect cyclosporin levels in plasma.

Model interaction with Metoprolol

metoprolol is a cytochrom P450 isoenzym 2d6. Drugs that have the same effect as enzyme or enzyme inhibitors on CYP2D6 may affect the plasma concentration of Metoprolol.

CYP2D6 inhibitors can lead to increased plasma metoprolol levels. Example:

Anti-arrhythmia (for example: Quinidin, Propafenon);

antihistamine anti-histamine (e. Anti-psychosis;

Cox-2 inhibitors (for example: Celecoxib);

When using propafenon initially treated in 4 patients who are using Metoprolol, the plasma metoprolol levels increase by 2-5 times and 2 patients appear typical side effects of Metoprolol. This interaction is confirmed in testing over 8 healthy people.

diphenhydramin decreases (2.5 times) Metoprolol clearance to alpha-hydroxymetoprolol by hydroxylation quickly via CYP2D6.

alcohol and hydralazin may increase the concentration of metoprolol in plasma. Rifampicin reduces Metoprolol levels in plasma.

The following combinations with Plendil Plus need to adjust the dose

Sympathetic inhibitors, Mao inhibitors, other β blockers: Need to monitor closely when using simultaneously Plendil Plus with sympathetic inhibitors, other β blockers (for example, eye drops) or capillary inhibitors.

Clonidin: If it is necessary to stop using the clonidin at the same time, Plendil Plus must be stopped for a few days before stopping clonidin.

Calcium channel blockers: can increase the effect of inhibiting heart contractions and slow heart rate when used in combination with Plendil Plus and calcium channel blockers belonging to the Verapamil or Diltiazem group. Venus injection should not be administered in the Verapamil group when used with Plendil Plus.

Antihyodfight drugs: Plendil Plus can increase the effect of inhibiting heart contractions and slow conduction of anti -arrhyths (quinidine and amiodaron).

Digitalis Glycoside: When combined with 3, Digitalis Glycosides can increase the atrial transmission time and can cause slow heart rate.

Inhaled anesthesia: Inhaled anesthesia can increase the inhibition of myocardial inhibitor in patients treated with Plendil Plus.

Prostaglandin synthetic enzyme inhibitors: In combination with indomethacin or other prostaglandin synthetic enzyme inhibitors can reduce the effectiveness of plentil plus.

Adrenalin: under determining conditions, when patients use adrenalin along with β blockers may occur significant hypertension and slow heart rate. Selective β blockers on the heart less affects blood pressure control than non -selective β blockers.

Oral diabetes treatments: may need to adjust the dose of oral diabetes treatment in patients who are using Plendil Plus. Phenylpropanolamine: Single doses of phenylpropanolamine (norephredrin) 50mg may cause diastolic hypertension to pathological values in healthy people in research. Propranolol often loses the effect of hypertension caused by phenylpropanolamine. However, β blockers may cause a reaction to hypertension on patients who are taking high doses of phenylpropanolamine. Hypertension during treatment with individual phenylpropanolamine is also described in some cases.

Storage

temperature does not exceed 30ºC.

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