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Each tablet contains nimetazepam 5 mg.
Excipients/Inactive Ingredients: Lactose, starch, povidone, sunset yellow FCF, Magnesium stearate, purified water.
Pharmacology: Mechanism of Action: Although Nimetazepam exhibits a spectrum of activity (harmless, sedative, muscle relaxant, stimulates and promotes sleep, anti-convulsant effects, etc.) similar to Nitrazepam, it is stronger and faster acting compared to Nitrazepam (in mice and rats). The mechanism of hypnotic action of nimetazepam is considered to be related to suppression of the emotional mechanisms of the limbic system and hypothalamus and suppression of the activating limbic system.
Pharmacokinetics: Nimetazepam appears rapidly in the blood after oral administration of 5 mg in healthy adult subjects and the blood concentration is 10.4 ng/ml at 1 hour after administration which is similar to the concentration (13.4 ng/mL) within 2-4 hours when the peak level is reached. Hence, Nimetazepam exhibits higher initial blood concentrations than Nitrazepam. The 1-desmethyl and 3-hydroxy forms were identified as blood metabolites but its blood level were quite low in comparing to blood concentrations of unchanged compounds.
For adults, generally, a single dose of 5 mg of Nimetazepam is administered orally at bedtime. For the treatment of insomnia, patients must be informed to consume LAVOL shortly before bedtime. LAVOL is not given to patients who should awake and work during bedtime, since the drug has been taken shortly before bedtime.
Patients with narrow angle glaucoma (Caution should be exercised with increased intraocular pressure, which may exacerbate symptoms). Patients with myasthenia gravis (there is a concern regarding increased symptoms).
Nimetazepam has a lasting effect until the next day, which can cause drowsiness and reduced attention, concentration and reflexes. Patients should be warned not to drive or operate machinery while taking nimetazepam.
The presence of other medical history that may impair the drug efficacy. Therefore, be sure to tell the doctor if the patient has a history of health problems, especially in the following conditions: cardiac disorders (caution for worsening of symptoms), hepatic or renal impairment (caution for delayed excretion), brain disorders (caution should be increased), elderly (Refer to “Use in the elderly”), marasmus (caution should be performed on manifestation of the adverse effect), infants and Children (cautions should be increased).
Patients with severe respiratory function impairment due to cor pulmonale, pulmonary emphysema, bronchial asthma or acute cerebrovascular disorders [Carbon dioxide (CO2) narcosis may occur].
Use in Pregnancy: Due to the unavailability of drug safety data for pregnant women, the drug should not be used by pregnant women and those planning a pregnancy, unless, according to the doctor, the benefits provided outweigh the possible risks.
In drug studies on pregnant experimental animals, suppression of fetal weight gain and decreased viability of neonates was observed.
In the epidemiological survey it was stated that patients who received benzodiazepine-derived drugs during pregnancy gave birth to babies with congenital abnormalities, with a much higher rate than controls
It was reported that benzodiazepines cause symptoms such as difficulty eating, nausea, decreased activity, hypotonia, hypertonia, somnolence, respiratory depression/apnea, cyanosis, irritability, hypersensitivity, tremor, hypothermia, and tachycardia in neonates. There is a case where symptoms developed as a result of withdrawal symptoms or asphyxia in the neonate. It has also been reported that benzodiazepines showed an increase in the incidence of neonatal jaundice.
Repeated administration of other benzodiazepines (diazepam) before delivery has been reported to cause withdrawal symptoms (anxiety, tremor, hypertonia, etc.).
Use in Lactation: This drug has been reported to increase the incidence of neonatal jaundice. Therefore, it is not recommended for use in nursing mothers. If this drug must be used in nursing mothers, the patients must stop breastfeeding.
In studies on experimental animals during the lactation period, decreased viability in neonates was found.
It has been reported that another benzodiazepine (diazepam) is excreted into breast milk, causing lethargy and weight loss in infants.
Use in Pregnancy: Due to the unavailability of drug safety data for pregnant women, the drug should not be used by pregnant women and those planning a pregnancy, unless, according to the doctor, the benefits provided outweigh the possible risks.
In drug studies on pregnant experimental animals, suppression of fetal weight gain and decreased viability of neonates was observed.
In the epidemiological survey it was stated that patients who received benzodiazepine-derived drugs during pregnancy gave birth to babies with congenital abnormalities, with a much higher rate than controls
It was reported that benzodiazepines cause symptoms such as difficulty eating, nausea, decreased activity, hypotonia, hypertonia, somnolence, respiratory depression/apnea, cyanosis, irritability, hypersensitivity, tremor, hypothermia, and tachycardia in neonates. There is a case where symptoms developed as a result of withdrawal symptoms or asphyxia in the neonate. It has also been reported that benzodiazepines showed an increase in the incidence of neonatal jaundice.
Repeated administration of other benzodiazepines (diazepam) before delivery has been reported to cause withdrawal symptoms (anxiety, tremor, hypertonia, etc.).
Use in Lactation: This drug has been reported to increase the incidence of neonatal jaundice. Therefore, it is not recommended for use in nursing mothers. If this drug must be used in nursing mothers, the patients must stop breastfeeding.
In studies on experimental animals during the lactation period, decreased viability in neonates was found.
It has been reported that another benzodiazepine (diazepam) is excreted into breast milk, causing lethargy and weight loss in infants.
Drug addiction: Continued use of large doses of Nimetazepam can lead to drug dependence, so drug administration must be carefully monitored in order to not to exceed the recommended dose. Reducing the dose or stopping use suddenly and continuing use can result in withdrawal symptoms such as convulsions, delirium, tremors, insomnia, anxiety, hallucinations and sometimes delusions. Therefore, discontinuation of use should be done gradually.
Psychoneurological: In patients with psychoses such as schizophrenia, paradoxical reactions eg., excitement, arousal and confusion may occur.
Lightheadedness, drowsiness, dizziness, discomfort, irritability, tremors, tinnitus and dysarthia may occur.
Liver: Occasionally, increased GOT, GPT and ALP.
Gastrointestinal: Occasionally, anorexia, nausea, vomiting, abdominal discomfort, diarrhea and abdominal pain may occur.
Heart: Occasionally, palpitation may occur.
Hypersensitivity: Hypersensitivity reactions eg. rash & skin redness may occur. If these symptoms occur, treatment should be immediately discontinued.
Musculoskeletal: Hypotonic symptoms ie. malaise, weakness, back pain & shoulder stiffness may occur.
Others: Thirsty, sweating, night sweating may occur.
The effects of LAVOL may be increased when administered concomitantly with CNS depressants (phenothiazine derivatives & barbiturates), alcohol-containing beverages, MAO inhibitors. These medications are recommended not to be co-administered. However, if concomitant use is considered for essential purposes, the administration should be taken with caution.
N05CD15 - nimetazepam ; Belongs to the class of benzodiazepine derivatives. Used as hypnotics and sedatives.
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