Naphalon Ophthalmic Solution 0.005%+0.02%
Naphalon Ophthalmic Solution 0.005%+0.02% Uses, Dosage, Side Effects, Food Interaction and all others data.
Naphazoline is a rapid acting imidazoline sympathomimetic vasoconstrictor of ocular or nasal artierioles. It acts to decrease congestion and is found in many over the counter (OTC) eye drops and nasal preparations.
Naphazoline was first developed in 1942 as a nasal formulation for congestion.
Naphazoline is a sympathomimetic alpha adrenergic agonist that acts to vasoconstrict nasal or ocular arterioles, resulting in reduced congestion at the site of administration.
Zinc sulfate is the inorganic compound with the formula ZnSO4 and historically known as "white vitriol". It is on the World Health Organization's List of Essential Medicines, a list of the most important medication needed in a basic health system.
Zinc has been identified as a cofactor for over 70 different enzymes, including alkaline phosphatase, lactic dehydrogenase and both RNA and DNA polymerase. Zinc facilitates wound healing, helps maintain normal growth rates, normal skin hydration and the senses of taste and smell.
| Trade Name | Naphalon Ophthalmic Solution 0.005%+0.02% |
| Generic | Naphazoline + Zinc Sulfate |
| Weight | 0.005%+0.02% |
| Type | Ophthalmic Solution |
| Therapeutic Class | Ophthalmic Non-Steroid drugs |
| Manufacturer | Reman Drug Laboratories Ltd. |
| Available Country | Bangladesh |
| Last Updated: | October 19, 2023 at 6:27 am |
Uses
Acute and chronic non-infectious conjunctivitis, nonspecific conjunctival irritation; also after successful treatment of bacterial and viral conjunctivitis. Irrigation of the tear ducts.Naphalon Ophthalmic Solution 0.005%+0.02% is also used to associated treatment for these conditions: Bacterial Conjunctivitis, Blepharoconjunctivitis, Conjunctivitis, Conjunctivitis allergic, Dacryocystitis, Dacryostenosis, Dermatitis, Eczematous of the Eyelid, Eye Pain, Eye redness, Iritis, Lacrimation, Nasal Allergies, Nasal Congestion, Noninfective conjunctivitis, Otitis Media (OM), Photophobia, Foreign body sensation in eye, Ocular bacterial infections, Ocular vasoconstrictionDry Eyes, Local itching, Localized pain, Localized swelling, Nutritional supplementation
How Naphalon Ophthalmic Solution 0.005%+0.02% works
Naphazoline is a vasoconstrictor that functions by stimulating alpha adrenergic receptors in arterioles leading to decreased congestion at the site of administration.
Naphazoline causes the release of norepinephrine in sympathetic nerves. Norepinephrine binds to alpha adrenergic receptors and causes vasoconstriction. Naphazoline is also a mild beta adrenergic receptor agonist, which can cause rebound vasodilation after the alpha adrenergic stimulation has ended. Naphazoline's release of norepinephrine also triggers a negative feedback loop which decreases production of norepinephrine, which can lead to rhinitis medicamentosa after long term use when naphazoline is stopped.
Zinc inhibits cAMP-induced, chloride-dependent fluid secretion by inhibiting basolateral potassium (K) channels, in in-vitro studies with rat ileum. This study has also shown the specificity of Zn to cAMP-activated K channels, because zinc did not block the calcium (Ca)-mediated K channels. As this study was not performed in Zn-deficient animals, it provides evidence that Zn is probably effective in the absence of Zn deficiency. Zinc also improves the absorption of water and electrolytes, improves regeneration of the intestinal epithelium, increases the levels of brush border enzymes, and enhances the immune response, allowing for a better clearance of the pathogens.
Dosage
Naphalon Ophthalmic Solution 0.005%+0.02% dosage
Adults: 1 drop in the conjunctival sac, three to 4 times per day.Children: Naphazoline nitrate and Zinc sulphate drops has not been studied in children. Generally, in children the dosage of vasoconstrictors should be low and selected with caution.Side Effects
Mydriasis and a slight increase of intraocular pressure in isolated cases. A slight and transient burning sensation may occur after instillation, which does not affect the success of the treatment. Long term use may result in reactive redness of the eye (rebound effect).In very rare cases systemic cardiovascular effects, such as hypertension and arrhythmia, may occur. Nonspecific fatigue has been observed in some patients.Toxicity
In high doses or when ingested, naphazoline can lead to central nervous system depression (which can progress to coma and death), hypothermia, bradycardia, and death. This effect is especially pronounced in children under 6 years.
Long term use of naphazoline can lead to rhinitis medicamentosa once naphazoline is stopped. This condition is a result of norepinephrine release by naphazoline triggering a negative feedback loop.
Safety and effectiveness in children under 12 has not been established. Studies in elderly patients have yet to be performed. Risk in pregnancy, breast feeding, and on overall fertility have not been established, though pregnant and breast feeding patients should consider the risk and benefit before starting naphazoline treatment.
Human : TDLo ( Oral) 45mg/kg/7D-C : Normocytic anemia, pulse rate increase without fall inBP Human: TDLo (oral) 106mg/kg : Hypermotylity, diarrhea Mouse ; LD50 Oral : 245mg/kg Mouse : LD50 : subcutaneous : 781mg/kg
Precaution
Uncontrolled use of Naphazoline & Zinc over extended periods of time should be avoided. If no improvement is seen after 2 days, treatment should be discontinued and other therapeutic measures should be considered. If ocular discomfort or visual disturbance occurs during Naphazoline & Zinc treatment, the therapy must be discontinued. Caution is indicated in patients with predisposition to glaucoma and in patients suffering from hypertension, cardiovascular diseases, pheochromocytoma, aneurysm, hyperglycemia, and hyperthyroidism.Interaction
Naphazoline containing products should not be administered during treatment with MAO-blockers nor during 10 days after discontinuation of such treatment. The effects of Naphazoline may be increased by concomitant use of tricyclic antidepressants.Volume of Distribution
Distribution data for naphazoline are scarce but imidazoline compounds are distributed throughout the body, and can cross the blood-brain barrier.
After absorption zinc is bound to protein metallothionein in the intestines. Zinc is widely distributed throughout the body. It is primarily stored in RBCs, WBCs, muscles, bones, Skin, Kidneys, Liver, Pancreas, retina, and prostate.
Elimination Route
Absorption data for naphazoline are scarce but imidazoline compounds in general are weakly basic and lipophilic, with high bioavailability from the gastrointestinal tract.
Approximately 20 to 30% of dietary zinc is absorbed, primarily from the duodenum and ileum. The amount absorbed is dependent on the bioavailability from food. Zinc is the most bioavailable from red meat and oysters. Phytates may impair absorption by chelation and formation of insoluble complexes at an alkaline pH. After absorption, zinc is bound in the intestine to the protein metallothionein. Endogenous zinc can be reabsorbed in the ileum and colon, creating an enteropancreatic circulation of zinc.
Half Life
Half life has not been determined but effects last for 4 to 8 hours. Other imidazoline compounds have half lives varying from 2 to 12 hours.
3 hours
Clearance
Clearance data for naphazoline is unavailable.
Elimination Route
Imidazoline compounds undergo some hepatic metabolism but a large fraction of the dose may be excreted unchanged in the urine. Urinary excretion is higher with more acidic urine.
Primarily fecal (approximately 90%); to a lesser extent in the urine and in perspiration.
Pregnancy & Breastfeeding use
Use in pregnancy: There are neither controlled animal studies nor studies in pregnant women available.Use in lactation: The effects of Naphazoline & Zinc treatment during lactation have not been investigated.Contraindication
Hypersensitivity to zinc sulphate, Naphazoline and other ingredients. Naphazoline & Zinc is contraindicated in patients suffering from narrow-angle glaucoma, dry eye and especially keratoconjunctivits sicca Sjogren's syndrome. Naphazoline & Zinc must not be used in infants.Innovators Monograph
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