Navoproxin Plus 20 tablets

Trade Name:

Navoproxin Plus

20 Tablets

Composition:

Each tablet contains: 

Meclizine HCI 25 mg,

Pyridoxine HCI – 50 mg

Inactive ingredients: 

Lactose monohydrate, maize starch, magnesium stearate.

Properties:

Navoproxin Plus is an antiemetic. Navoproxin Plus is a combination of

Meclizine HCL and Pyridoxine HCL. Meclizine HCL is a piperazine- derivative antihistamine that is used as an antiemetic. It has antiemetic, anticholinergic and antihistaminic properties. It exhibits its action by an effect on CNS, possibly by its ability to block muscarinic receptors in the brain. It has marked effects in blocking the vasodepressor response to histamine, but only a slight blocking action against acetylcholine. It reduces the sensitivity of the labyrinthine apparatus. The site and mechanism of action of Meclizine HCI in controlling vertigo from various conditions have not been clearly defined.

Pyridoxine HCL (Vitamin B6), either alone or combination, has been used to prevent nausea and vomiting due to its antiemetic properties.

Indications:

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.

Directions for use:

Adults and children above 12 years of age:

-For motion sickness: the usual oral dose is 1 to 2 tablets taken about one hour before traveling and repeated every 24 hours if necessary.

-For morning sickness: the usual oral dose 

 is 1-2 tablets daily at bedtime.

-For the treatment of vertigo and vestibular disorders: up to 4 tablets/daily in divided doses 

-Radiation sickness: 2 tablets daily 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.

-Missed dose: If a dose is missed, take the missed dose as soon as you remember. If it is almost time for the next dose, skip the missed dose and take only the next regularly scheduled dose. Do not take a double dose of this medication.

Contraindications:

-hypersensitivity to meclizine HCI, pyridoxine HCI or any of the drug ingredients;

– the first trimester of pregnancy;

– the last 2 weeks of pregnancy due to risk of retrolental fibroplasia;

– children below 12 years of age,

– in patients on Levodopa therapy.

Warnings and Precautions

• Patients should avoid alcoholic beverages while taking this drug.
• Due to its potential anticholinergic action, this drug should be used with caution in patients with asthma, glaucoma, or enlargement of the prostate gland.
• This drug contains lactose. Patients with rare hereditary problems of galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption should not take this medication.
• Usage in Children: clinical studies establishing safety and effectiveness in children have not been done; therefore, usage is not recommended in children under 12 years of age.
• Hepatic Impairment: the effect of hepatic impairment on the pharmacokinetics of meclizine has not been evaluated. As meclizine undergoes metabolism, hepatic impairment may result in increased systemic exposure of the drug. Treatment with meclizine should be administered with caution in patients with hepatic impairment.

• Renal Impairment: the effect of renal impairment on the pharmacokinetics of meclizine has not been evaluated. Due to a potential for drug/metabolite accumulation, meclizine should be administered with caution in patients with renal impairment and in the elderly as renal function generally declines with age.

Drug interactions:

• Pyridoxine reduces Levodopa’s effectiveness by increasing its peripheral metabolism. Phenytoin serum levels may be decreased.
• There may be increased CNS depression when meclizine is administered concurrently with other CNS depressants, including alcohol, tranquilizers, and sedatives.
• Based on in-vitro evaluation, meclizine is metabolized by CYP2D6.

Therefore there is a possibility fora drug interaction between meclizine and CYP2D6 inhibitors.

• Concurrent use of other anticholinergics can potentiate the anticholinergic effects of meclizine.

Pregnancy and Lactation:

• Usage in Pregnancy: meclizine should be used during pregnancy only if clearly necessary.

Navoproxin plus is not used completely during the first trimester of pregnancy.

Not recommended in last 2 weeks of pregnancy due to risk of retrolental fibroplasia.

• Nursing Mothers: it is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be taken when meclizine is administered to a nursing woman.

Side Effects:

Anaphylactoid reaction, drowsiness, dry mouth, headache, fatigue, vomiting and, on rare occasions, blurred vision have been reported regarding meclizine.

Sensory neuropathy reported with high doses of pyridoxine hydrochloride given for extended periods.

• Since drowsiness may, on occasion, occur with use of this drug,

patients should be warned of this possibility and cautioned against

driving a car or operating dangerous machinery.

Storage:

Store at a temperature not exceeding 30°C

Package:

Carton box contains two strips each of 10 tablets and insert leaflet.