Phamzopic tablets 7.5mg pharmascascionation for sleep disorders (100 tablets)

Dosage form Box of 100 capsules
Specifications ZopiClone

Ingredient

Composition information	Content
ZopiClone	7.5mg

Uses

Indications

Phamzopic medicine is indicated in the following cases:

Treatment of sleep disorders is caused by body abnormalities and/or mental illness. Therefore, it is only recommended to treat insomnia symptoms for patients after careful evaluation of the patient's condition. In case of continuous treatment for 2 to 3 weeks, it is necessary to comprehensively check the patient's condition. ZopiClone should only be prescribed in a short time (7 - 10 days) and should not be prescribed for 1 month. ZopiClone belongs to the new chemical group with chemical formulas unlike existing sedatives. However, the pharmaceutical properties of the drug are similar to the substance of benzodiazepin.

In sleep studies for 1 to 21 days in humans, Zopiclone causes the patient to fall asleep fast, prolong the time of sleep and reduce the number of waking up during sleep. ZopiClone slows down the time to start sleeping often (REM) but does not reduce the total time of the Remen sleep. The period of phase 1 of sleep is shorter and phase 2 of sleep is longer.

In most studies, the phase 3 and 4 of sleep tends to be longer but there are phenomena of these stages that have not changed and the actual is shortened. The effect of zopiClone on the stage 3 and 4 of sleep is different from benzodiazepine drugs, it prevents short -wave sleep. The clinical significance of this finding is not known.

With sedative drugs, the duration of excretion and distribution affects the effects and side effects of the drug and its metabolites. If the selling time is long (T1/2 α and T1/2β), the drug or the metabolites will accumulate when taking the night medicine and will affect awareness and exercise when waking up. If the sale time is short, the drug and metabolite will be eliminated from the body before the next dose and sedative effects or central nervous inhibitors due to the dose left less or no longer hurt.

If the duration of the excretion of the drug is extremely short, the effect of the drug will end at some point of the night. There may be two cases where the following occurred with benzodiazepine sedative drugs or similar drugs except for rapid excretion: 1) The awakening in the last third of the night increases and 2) The anxiety in the day increases.

pharmacokinetic

absorption

The drug absorbs fast and completely. Bioions reach over 75%, indicating that the drug is not metabolized through the head liver. After taking the dose of 7.5 mg, the peak concentration of the blood in the blood reached 60 ng/ml for 2 hours. The absorption of drugs in men and women is the same. The pharmacokinetic properties of the drug do not change when taking the daily dose of 7.5 mg for 14 days and does not lead to the accumulation of the drug.

Distribution

After taken, the drug quickly distributed into the body's blood vessel system (T1/2 distribution of the drug is 1.2 hours) while the deduction time is nearly 5 hours (from 3.8 - 6.5 hours). The drug is associated with low plasma proteins (about 45% in a concentration of 25 - 100 ng/ml) and is not saturated, so the risk of drug interaction due to affiliate disputes is low.

Metabolism

The drug is metabolized mostly into 3 main metabolites. Only about 4 - 5% of the drug excreted through the urine in the status quo. The main metabolites with weak pharmacokinetic activity in animals are n-oxide derivatives (about 12%) and the non-active chemical substance is N-Desmethyl (16%). Their selling time is about 4.5 hours and 7.4 hours of calculation based on urine analysis data.

Both metabolites are eliminated through the kidneys. The main metabolites due to the oxidation of decarboxyl oxidation are partially eliminated through the lungs in the form of CO2. In animals, zopiClone does not affect liver enzymes.

Elimination

Essence studies using 14C marking methods show that over 90% of oral drugs are eliminated for about 5 days, 75% are eliminated through urine and 16% in feces.

Compared to plasma clearance, the renal clearance in the constant form of zopiClone is low (8.4 ml/minute compared to 232 ml/minute), proving that transformation is the main clearance of zopiClone.

Before taking Phamzopic tablets 7.5mg pharmascascionation for sleep disorders (100 tablets)

How to use

Take oral use.

Drugs should be taken immediately before going to bed.

Dosage

Use Phamzopic should not last more than 7-10 days in a row. In case of continuous treatment for 2 to 3 weeks, it is necessary to comprehensively check the patient's condition.

Dosage for adults

Usually 1 tablet Phamzopic 7.5 mg. Do not overdose.

Older people

recommended dose for the elderly and/or weak health patients is ½ tablet (3.75 mg) before sleep. The dose may increase to 1 tablet in the case of low doses without the desired effect.

Patients with impaired liver function or chronic respiratory failure

The recommended dose is 3.75 mg (1/2 tablets) depending on the level of response and effect of the drug. The dose of up to 7.5 mg (tablets) may be used in case of necessity but must be cautious.

Zopiclone should not be used for patients under 18 years old.

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

In volunteers or by accidentally taking Zopiclone to 340 mg, the main symptoms are recorded: Sleep is prolonged, drowsy, sleepy and loss of air conditioning. All zopiclone overdose manifestations are related to the pharmacological characteristics of the drug: drowsiness, confusion, dizziness, reduction or loss of reflexes.

Handling

Support treatment and clinical signs. Respiratory, vascular and blood pressure monitoring should be monitored and supported treatment when necessary. Need gastric lavage now. Intravenous infusion and ensure good ventilation. Hemorrhage does not bring results. Flumazenil is a specific antagonistic drug with a receptor of benzodiazepin, which can be used in the case of overdose of benzodiazepine and similar drugs.

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 Phamzopic medicine, you may experience unwanted effects (ADR).

The most common effect when taking the drug is bitter. The condition is too drowsy, drowsy and/or loss of coordination is a sign of drug intolerance or overdose.

Side effects are more common in italic in Zopiclone than Placebo:

The central nervous system: drowsiness, weakness, dizziness, confusion, temporary loss of memory, drunkenness, absence, nightmares, confused mood, anxiety or restlessness, hostile feeling, depression, decreased sexual desire, loss of coordination, reducing muscle tone, tremor, cramps, sensations of cows, hard -to -speak.

Cardiovascular: Brushing the chest.

Digestive: dry mouth, white tongue, smell, nausea, vomiting, indigestion, diarrhea, constipation, anorexia or eating a lot.

Respiratory: Difficulty breathing.

senses: Reduce vision.

Skin: itching, rash, increased sweating. Itching may be a sign of hypersensitivity to the drug, then stop taking the drug.

Other symptoms: bitter mouth, headache, feeling of severe legs, shivering.

Testing: Sometimes the tests are affected when taking the drug including an increase in AST, ALT or alkaline phosphatase.

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

Phamzopic medicine is contraindicated in the following cases:

Patients with hypersensitivity to drugs or ingredients of the drug.

Patients with severe respiratory failure (as in sleep apnea syndrome).

Patients who have had an abnormal reaction to alcohol and/or sedative.

Precautions when used

The drug should be used carefully for patients who have been reacted abnormally when using alcohol and/or sedative drugs.

For the elderly

Should only take medicine for the elderly at the lowest doses to work. Using an appropriate high -dose sedative in the elderly can cause unforeseen consequences.

If using sedatives does not work after 7-10 days, can think of a mental illness and/or any other primary pathological state or the phenomenon of loss of sleep reflexes.

Increased insomnia or the appearance of new abnormalities about thoughts or behaviors may be the consequence of the mind/body disorder. These cases have also been reported regarding the use of drugs on the benzodiazepine receptor.

Need to use zopiclone for patients with severe myasthenia gravis or severe impairment of liver function.

Patients should be warned that Zopiclone should not be used in cases when they do not have a night sleep so that the drug is not excreted from the body before they continue the activities the next day.

Confusion

benzodiazepine and similar drugs affect brain ability as concentration, attention and vigilance. The risk of confusion is common in the elderly or patients with brain damage.

Anxiety, insecurity

During ZopiClone treatment, it is noticed an increase in the situation in the day and/or insecure. This may be due to the short selling time of the drug, so the doses appear the same situation as the drug is discontinued.

Depression

Be cautious when taking medication for patients with signs and symptoms of depression, then sleeping pills can make the disease worse. The risk of overdose is huge in patients with depression; Therefore, only a minimum amount of drugs should be given.

Abuse, dependency and remedy

Avoid sudden stopping the drug and a slow dosage is needed for any patient to take the medication for several weeks. The reduction of special dose should be noted when taking the drug for patients with a history of convulsions. The risk of increased drug dependence in patients who have been alcoholic, drug use, or in patients with personality disorders.

The condition of patients who are worried during the day during medication and recurrence may increase the risk of drug dependence in patients treated with Zopiclone. Like other sedatives, it is necessary to restrict the medication for patients who are being monitored.

Patients with special conditions

Be careful when using zopiClone for patients with impaired liver or kidney function or severe respiratory failure. Respiratory inhibitors were recorded when taking drugs for patients with respiratory dysfunction.

Patients need alertness

Due to ZopiClone's central neurological inhibition effect, be cautious when taking the drug for patients who perform jobs that need alertness such as operating machinery or driving. For the same reason, it is necessary to warn patients on simultaneous use of zopiClone and alcohol or other central neurological inhibitors.

Use children's drugs

Safety and effectiveness when taking children under 18 years of age has not been established.

Take medicine for the elderly

Use an appropriate high -dose sedative in the elderly can cause unforeseen consequences. Therefore, the lowest dose is required for older diseases.

The ability to drive and operate machinery

The sedative effect of the drug lasts until the next day is less and generally not significant. However, patients should not operate machinery or driving the next day, after taking the drug until it is determined that their activity is not affected. If used with alcohol, this risk increases.

Pregnancy

Children were born by mothers who use benzodiazepins and similar drugs at risk of withdrawal symptoms.

Breastfeeding period

Excreted drugs through breast milk, so they do not use medicine for breastfeeding women.

Medicinal interaction

alcohol can increase the sedative effect of the drug, especially affecting the ability to drive or operate the patient's machines when used simultaneously, so it should not be coordinated.

Taking medication simultaneously with central neurological inhibitors will increase the central nervous inhibitor. Therefore, it is necessary to consider the benefits of treatment when used simultaneously with anti -psychotic drugs (sleeping pills), sedative drugs, anti -anxiety/soothing drugs, antidepressants, sleeping painkillers, anti -epileptic drugs, anesthetic and antihistamines that have sedative effects. Use a combination of benzodiazepine derivatives or similar drugs with painkillers that can increase the refreshing effect and lead to drug dependence.

The use in combination with the drug has the effect of inhibiting liver enzymes (especially Cyt P450) may increase the effects of benzodiazepine and similar drugs. Because ZopiClone is metabolized by CYP 3A4, Zopiclone's blood concentration increases when used simultaneously with CYP 3A4 inhibitors such as erythromycin, Clarithromycin, Ketoconazole, Itraconazole and Ritonavir. Zopiclone dose is needed when used simultaneously with these drugs.

In contrast, Zopiclone's blood concentration decreases when used simultaneously with CYP 3A4 stimulants such as rifampicin, Carmabazepine, phenobarbital, phenytoin. At that time, ZopiClone's dose is needed.

Storage

Store at temperatures below 30 ° C.

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