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Product Name
:
NAVIFEMM
Chemical Name
:
Meclizine HCl + Vitamin B6
Therapeutic Category
:
Miscellaneous drugs
Pharmacologic Category
:
Antiemetic - Histamine H1; Antagonist - Histamine H1; Antagonist, First Generation - Piperazine Derivative
Pharmaceutical Form
:
Composition
:
Meclizine HCl + Vitamin B6
Monitoring Parameters
Dosing
 
Dosing: Adult
Motion sickness: Oral: 12.5-25 mg 1 hour before travel, repeat dose every 12-24 hours if needed; doses up to 50 mg may be needed
Vertigo: Oral: 25-100 mg/day in divided doses

Dosing: Pediatric

Children >12 years: Refer to adult dosing.

Dosing: Geriatric

Refer to adult dosing.
Use
 
Prevention and treatment of symptoms of motion sickness; management of vertigo with diseases affecting the vestibular system
Adverse Reactions
 
>10%:
Central nervous system: Slight to moderate drowsiness
Respiratory: Thickening of bronchial secretions
1% to 10%:
Central nervous system: Headache, fatigue, nervousness, dizziness
Gastrointestinal: Appetite increase, weight gain, nausea, diarrhea, abdominal pain, dry mouth
Respiratory: Pharyngitis
<1% (Limited to important or life-threatening): Bronchospasm, hepatitis, hypotension, palpitation
Contraindications
 
Hypersensitivity to meclizine or any component of the formulation
Warnings / Precautions Drug
 
Concerns related to adverse effects:
• CNS depression: May cause CNS depression, which may impair physical or mental abilities; patients must be cautioned about performing tasks which require mental alertness (eg, operating machinery or driving).
Disease-related concerns:
• Asthma: Use with caution in patients with asthma.
• Glaucoma: Use with caution in patients with narrow-angle glaucoma; condition may be exacerbated by cholinergic blockade. Screening is recommended.
• Prostatic hyperplasia/urinary stricture: Use with caution in patients with prostatic hyperplasia and/or urinary stricture.
• Pyloric/duodenal obstruction: Use with caution in patients with pyloric or duodenal obstruction.
Special populations:
• Elderly: Use with caution in the elderly; may be more sensitive to adverse effects.
• Pediatrics: Safety and efficacy have not been established in children <12 years of age.
Concurrent drug therapy issues:
• Sedatives: Effects may be potentiated when used with other sedative drugs or ethanol.
Other warnings/precautions:
• Lack of response: If vertigo does not respond in 1-2 weeks, it is advised to discontinue use.
Interactions
 
Acetylcholinesterase Inhibitors (Central): Anticholinergics may diminish the therapeutic effect of Acetylcholinesterase Inhibitors (Central). Acetylcholinesterase Inhibitors (Central) may diminish the therapeutic effect of Anticholinergics. If the anticholinergic action is a side effect of the agent, the result may be beneficial. Risk C: Monitor therapy
Alcohol (Ethyl): CNS Depressants may enhance the CNS depressant effect of Alcohol (Ethyl). Risk C: Monitor therapy
Amphetamines: May diminish the sedative effect of Antihistamines. Risk C: Monitor therapy
Anticholinergics: May enhance the adverse/toxic effect of other Anticholinergics. Exceptions: Levocabastine (Nasal); Paliperidone. Risk C: Monitor therapy
Benzylpenicilloyl Polylysine: Antihistamines may diminish the diagnostic effect of Benzylpenicilloyl Polylysine. Management: Suspend systemic H1 antagonists for benzylpenicilloyl-polylysine skin testing and delay testing until systemic antihistaminic effects have dissipated. A histamine skin test may be used to assess persistent antihistaminic effects. Risk D: Consider therapy modification
Betahistine: Antihistamines may diminish the therapeutic effect of Betahistine. Risk C: Monitor therapy
CNS Depressants: May enhance the adverse/toxic effect of other CNS Depressants. Exceptions: Levocabastine (Nasal). Risk C: Monitor therapy
Droperidol: May enhance the CNS depressant effect of CNS Depressants. Management: Consider dose reductions of droperidol or of other CNS agents (e.g., opioids, barbiturates) with concomitant use. Risk D: Consider therapy modification
HydrOXYzine: May enhance the CNS depressant effect of CNS Depressants. Risk C: Monitor therapy
Pramlintide: May enhance the anticholinergic effect of Anticholinergics. These effects are specific to the GI tract. Risk D: Consider therapy modification
Selective Serotonin Reuptake Inhibitors: CNS Depressants may enhance the adverse/toxic effect of Selective Serotonin Reuptake Inhibitors. Specifically, the risk of psychomotor impairment may be enhanced. Risk C: Monitor therapy
Pregnancy
 
B
Pregnancy Implications
No data available on crossing the placenta. Probably no effect on the fetus (insufficient data). Available evidence suggests safe use during pregnancy.
Lactation
 
Excretion in breast milk unknown/not recommended
Mechanism of Action
 
Has central anticholinergic action by blocking chemoreceptor trigger zone; decreases excitability of the middle ear labyrinth and blocks conduction in the middle ear vestibular-cerebellar pathways
Pharmacodynamics / Kinetics
 
Onset of action: ∼1 hour
Duration: 8-24 hours
Metabolism: Hepatic
Half-life elimination: 6 hours
Excretion: Urine (as metabolites); feces (as unchanged drug)
 
   
 
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