Lavol

Lavol Special Precautions

Manufacturer:

Kimia Farma

Marketer:

Pharmasolindo
The information highlighted (if any) are the most recent updates for this brand.
Full Prescribing Info
Special Precautions
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.
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