For prophylaxis and symptomatic relief of nausea, vomiting, dizziness, motion
sickness, radiation sickness and vertigo associated with diseases of vestibular
system (e.g. Meniere’s syndrome, labyrinthitis and other vestibular disturbances)
and morning sickness during pregnancy.
DOSAGE AND ADMINISTRATION
The fixed-dose combination (FDC) is recommended for oral administration.
Nausea & vomiting (including morning sickness in pregnancy): One tablet 1-2
times daily or as directed by physician.
Motion sickness: The initial dose is one or two tablets daily; it should be taken one
hour prior to journey for protection against motion sickness. Therefore, the dose
may be repeated every 24 hours as indicated for the duration of journey.
Vertigo:One tablet two times daily or as directed by physician.
Labyrinthine and vestibular disturbances: The optimal dose of Meclizine HCl is
usually 25 to 100 mg daily in divided doses, depending on the clinical response.
Radiation sickness: 50 mg (Meclizine HCl) administered 2 to 12 hours prior to
radiation treatment. Pyridoxine (vitamin B6) has been shown to be safe and
effective in dosages of 50 to 200 mg per day.
Drowsiness, dry mouth, urinary retention or rare occasions, blurred vision have
been reported. Sensory neuropathy reported with high dosage of Pyridoxine
hydrochloride given for extended periods.
Due to its potential anticholinergic action, patient with asthma, bronchitis,
emphysema, enlarged prostate, glaucoma or urinary tract blockade should take
Meclizine HCl (like other antiemetics) with caution.
PREGNANCY AND LACTATION
Meclizine HCl: Pregnancy category B. Large-scale human studies have not
demonstrated adverse fetal effects. It has been suggested that, based on available
data, Meclizine HCl presents the lowest risk of teratogenicity and is the drug of
first choice in treating nausea and vomiting during pregnancy.
Pyridoxine HCl: Pregnancy category A. Pyridoxine HCl itself is considered safe
during pregnancy and has been used in pregnant women without any evidence
of fetal harm.
Although Meclizine HCl may excrete into the milk, it causes no harm in nursing
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