Acliz Plus (Meclizine HCL + Pyridoxine HCL)
Description
Meclizine has antiemetic, anticholinergic and antihistaminic properties. It reduces the sensitivity of the labyrinthine apparatus. The action may be mediated through nerve pathways to the vomiting centre (VC) from the chemoreceptor trigger zone (CTZ), peripheral nerve pathways or other CNS centres. Pyridoxine Hydrochloride (Vit – B6), either alone or in combination has been used to prevent nausea & vomiting due to its antiemetic properties.
Presentation
Acliz Plus Tablet: Each film coated tablet contains Meclizine Hydrochloride USP 25 mg & Pyridoxine Hydrochloride BP 50 mg.
Indications
For prophylaxis and symptomatic relief of nausea, vomiting, dizziness, motion sickness, radiation sickness and vertigo associated with diseases of vestibular motion sickness, radiation sickness and vertigo associated with diseases of vestibular system, morning sickness during pregnancy, drug induced nausea, vomiting induced by oral contraceptives or Estrogen preparations.
Dosage & Administration
The fixed-dose combination is recommended for oral administration.
Nausea & vomiting (including morning sickness in pregnancy): One tablet 1-2 times daily.
Motion sickness: One or two tablets one hour prior to journey. The dose may be repeated every 24 hours as indicated for the duration of journey.
Vertigo: One tablet 2 times daily or as directed by physician. Labyrinthine and vestibular disturbances: The optimal dose of Meclizine Hydrochloride is usually 25 to 100 mg daily in divided doses, depending on the clinical response. Radiation sickness: 50 mg (Meclizine Hydrochloride) administered 2 to 12 hours prior to radiation treatment. Pyridoxine Hydrochloride (vitamin B6) has been shown to be safe and effective in dosages of 50 to 200 mg per day.
Contrainidications
Acliz Plus is contraindicated in individuals who have shown hypersensitivity to these ingredients.
Warning & Precautions
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.
Side effects
Drowsiness, dry mouth, urinary retention in rare occasions, blurred vision has been reported. Sensory neuropathy reported with high dosage of Pyridoxine Hydrochloride given for extended periods.
Drug interaction
There may be increased CNS depression when Meclizine Hydrochloride and Pyridoxine Hydrochloride is administered concurrently with other CNS depressants, including benzodiazepines, barbiturates, tricyclic antidepressants, opiate agonists, skeletal muscle relaxants, antihistamines, alcohol, tranquilizers. Meclizine Hydrochloride can increase the absorption of digoxin by decreasing gastrointestinal motility. MAO inhibitors may prolong and intensify the anticholinergic effects of meclizine Hydrochloride.
Use in special groups
Use in pregnancy: Meclizine Hydrochloride is pregnancy Category B drug. Large-scale human studies have not demonstrated adverse fetal effects. It has been suggested that, based on available data, Meclizine Hydrochloride presents the lowest risk of teratogenicity and is the drug of first choice in treating nausea and vomiting during pregnancy. On the other hand, Pyridoxine Hydrochloride is pregnancy category A drug. Pyridoxine Hydrochloride itself is considered as safe during pregnancy and has been used in pregnant women without any evidence of fetal harm.
Use in lactation: Meclizine Hydrochloride may be distributed into breast milk. However problem in human have not been documented. On the other hand, Pyridoxine Hydrochloride has no adverse effects during lactation.
Use in children: Safety and efficacy have not been established in children below 12 years of age.
Packing
Acliz Plus Tablet: Each box contains 100’s tablets in blister pack.
