SERNAL-4 Davipharm medicine treats acute and chronic mental diseases (10 blisters x 10 tablets)

Dosage form Box of 10 blisters x 10 tablets
Specifications Risperidone

Ingredient

Composition information	Content
Risperidone	4mg

Uses

indications

SERNAL - 4 drugs used in the treatment of acute and chronic mental disorders (including symptoms of yin and yang). When deciding to use Risperidon for a long time, physicians need to periodically evaluate the effectiveness of the drug with each patient.

Pharmacological

Risperidon is a benzisoxazol anti -psychotic drug, which has a selective antagonistic effect with Serotonin Type 2 receptor (5HT2) and Dopamine Type 2 receptor (D2).

Risperidon is also associated with adrenergic alpha1 receptor and with H1 histamine receptors. There are very few anti -cholinergic side effects.

A balanced effect between antagonism and receptor 5HT2 and D2 has a good effect against "positive" symptoms such as hallucinations, abnormal thoughts, hostility, speculation (paranoia) and anti -symptoms of "negative" symptoms such as mental disjoints, empathy, loss of social behavior, loss of words in psychiatric paralysis. This equilibrium effect also reduces the risk of Parkinson's syndrome.

Risperidon has a sedative effect, so there may be interaction with painkillers and sedatives.

Pharmacokinetics

absorption

Risperidon is well absorbed when drinking. Food does not affect the speed or level of absorption. After taking Risperidon, the plasma peak concentration is reached within 1 hour. Oral bioavailability is 66 ± 28% in people with stronger metabolism and higher in people with weak metabolism.

Distribution

The level of plasma protein is 89% for Risperidon and 77% for active metabolites. The distribution of Risperidon is 1 - 2 l/kg.

Metabolism

Risperidon is metabolized in the liver thanks to Cytochrom P450 2D6 into a major metabolic, active 9 - hydroxyrisididon. This substance is valid by Risperidon in terms of activity associated with receptors.

Elimination

In people with strong metabolism, the half -life of Risperidon is 3.2 ± 0.8 hours, the elimination in urine is 3 ± 2% and the clearance is 5.5 ± 2 ml/min/kg. The metabolites are active, 9 - Hydroxyrisperidon has half a lifetime of 20 ± 3 hours.

When intravenous injection, 35 ± 7% of the dose of risperidon is excreted in the form of active metabolites, mainly through the kidneys and therefore have correlation with the kidney function.

In people with weak metabolism, intravenously risperidon is eliminated in the form of unchangedness of 20% doses, 10% in the form of 9 - hydroxyrisperidon, steam clearance is less than 1 ml/min/kg and half -life of risperidon similar to that of active metabolites, about 20 hours. Half of the total of 2 Risperidon and 9 - Hydroxyreseidon is 20 - 24 hours.

Need to adjust the dose for people with kidney or liver disease.

Before taking SERNAL-4 Davipharm medicine treats acute and chronic mental diseases (10 blisters x 10 tablets)

How to use

Risperidon drugs are taken orally, 2 times a day. Food does not affect the gastrointestinal absorption of Risperidon.

Dosage

Dosage to treat mental disorders in adults, often used initial dose 1 mg, 2 times a day.

Can increase the dose with an increase of 1 mg, twice a day on Monday and Tuesday, if tolerated, until the dose of 3 mg, 2 times a day.

If hypotension occurs during the dose, the dose must be reduced. The next dose adjustment is usually done at a distance of at least 7 days, with an increase or decrease of 1 mg, 2 times a day.

The maximum effect of Risperidon is achieved at a dose of 4 - 6 mg daily. The daily dose higher than 6 mg does not work better but also causes worse ADRs, including foreign symptoms. Do not take the dose exceeding 6 mg daily.

Dosage in renal failure and liver failure:

Because Risperidon elimination may be reduced and the risk of unwanted effects, especially hypotension, increases in people with kidney failure and in the elderly, must start Risperidon treatment with reduced doses, use 0.5 mg, twice a day, can increase as needed and when possible tolerance, with an increase of 0.5 mg, 2 times a day. done at a distance of at least 7 days.

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?

Expression

In general, the common signs and symptoms are due to the sharp increase in the known pharmacological effects of drugs such as drowsiness, sedation, fast heart rate and hypotension.

Other effects include prolonged QT, convulsions and cardiac arrest - respiration.

Treatment

Set and maintain ventilation to ensure adequate oxygen supply. Gastric lavage (after placing the intubation, if the patient lost consciousness) and for activated carbon. Consciousness narrows, seizures or muscle disorders at the head and neck after an overdose may cause the risk of inhalation of vomiting when vomiting.

Must start the cardiovascular monitoring immediately and monitor the center of electrolyte continuously to detect possible arrhythmia. If the anti -arrhythmia is applied, do not use disoperamid, processing and quinidine because it also causes a long -lasting effect, plus the effect of risperidon.

Bretyergium's Alpha adrenergic blockers also plus the effect of Risperidon, leading to hypotension. Therefore, anti -arrhyths should be used other than the above drugs.

There is no specific antidote to Risperidon, which is required to use appropriate support. Treatment of hypotension and circulatory failure with intravenous fluid and/ or for drugs that are similar to sympathetic effects (not epinephrin and dopamine because beta stimulation may increase blood pressure due to the alpha blocker of risperidone).

In the case of severe foreign tower symptoms, using anti -cholinergic drugs. Closely monitor until the patient recovers.

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 SERNAL - 4 drugs, you may experience unwanted effects (ADR).

Common, ADR> 1/100

Central nervous system: dizziness , increase stimulation, anxiety, sleep, symptoms of the tower, headache , Parkinson's syndrome. Breathing. Sex.

No report.

Rare, ADR

Central nervous system: Concentration decrease, depression , apathy, tone reaction, refreshment, sexual increase, memory loss, difficulty speaking, dizziness, stunning state, parcels, confusion.

Tieu Hoa: flatulence, diarrhea, increased appetite, stomatitis, black stool, difficulty swallowing, hemorrhoids, gastritis.

Respiratory: fast breathing, bronchospasm, pneumonia , hissing.

Skin: Increase or decrease sweating, acne, hair loss.

Cardiovascular: Hypertension , reduced blood pressure, edema, atrial block, myocardial infarction.

Eyes: regulating disorders, dry eyes.

Endocrine and metabolism: Reducing sodium, increasing or weight loss, increased creatin phosphokinase, thirst, diabetes, non -periodic milk secretion, loss of menstruation, menstrual pain, big breasts.

Urinary - genital: bedwetting, bleeding, difficulty urination, female breast pain, mid -menstrual bleeding, vaginal bleeding.

Hematology: Nosebleeds, hemorrhage, Anemia .

Other: Roll, discomfort, symptoms like the flu.

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

Contraindicated

SERNAL - 4 contraindications in the following cases:

Patients with overdose of Barbiturat, preparations with opium or alcohol.

Be cautious when using

can minimize the risk of lowering and fainting blood pressure during treatment with risperidon by limiting the initial dose at 1 mg, 2 times a day for normal adults and 0.5 mg, 2 times a day for elderly people or weak people, people with impaired renal or liver function and people with risk of lowering blood pressure.

In people with cardiovascular disease (severe arteriosclerosis, heart failure, conduction disorders), cerebrovascular disease or states that are prone to hypotension (for example: dehydration, reduce blood flow, anti -hypertension therapy) and in people with a history of epilepsy, muscle spasm or Parkinson's syndrome, need to use lower doses and start treatment at low doses.

The ability to drive and operate machinery

Because Risperidon can disturb the ability to judge, think and motor skills, in addition the drug also has unwanted effects such as dizziness, headache, chicken sleep, ... Therefore, patients should not operate dangerous machines, including motor vehicles, until it is sure that Risperidon does not cause the desired effect.

Pregnancy

Do not use Risperidon for people during pregnancy.

Breastfeeding period

It is unclear whether the Risperidon is secreted into breast milk or not. People who are using Risperidon should not breastfeed.

Interactive drug

quinidine can increase the effect of the atrial - ventricular effect of risperidon.

Risperidon may increase the hypotension of the drug to treat hypertension.

Risperidon may be opposed to the effect of levodopa and dopamine owners.

Long -term use of carbamazepin along with risperidon may increase the effect of Risperidon.

The use of clozapin with risperidon may increase the effect of risperidon.

Due to the main effects on the central nervous system of Risperidon, risperidon doses must be used lower when combined with other central nervous and alcohol -acting drugs.

In all these cases, the dosage needs to be adjusted.

Storage

In a dry place, avoid light, the temperature does not exceed 30 ° C.

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