Composition of Methapyx N -Betnesol-N Eye/Ear Drops:
Betamethasone Sodium Phosphate BP 0.1% w/v Benzalkonium Chloride BP 0.02% w/v (As preservative)
Purified Water BP Q.S.
PHARMACOLOGICAL CLASSIFICATION:
Topical Corticosteroid and Antibiotics
PHARMACOLOGICAL ACTION:
Betamethasone is a glucocorticoid which has topical anti-inflammatory activity. Betamethasone has a five to sevenfold greater systemic anti-inflammatory activity than prednisolone.
Pharmacokinetic:
Absorption of topically applied betamethasone sodium phosphate into the aqueous humour of human subjects undergoing routine intraocular surgery was greatest in the interval 91-120 minutes following topical administration (mean peak concentration = 7.7 ng/ml). At twelve hours post-instillation the mean concentration of Betamethasone was 2.5 ng/ml and detectable levels were recorded in the aqueous humour 24 hours after application (mean concentration 0.4 ng/ml).
INDICATIONS of Methapyx N -Betnesol-N Eye/Ear Drops:
Betamethasone sodium Phosphate Eye Drops is indicated for the short-term treatment of steroid-responsive inflammatory conditions of the eye when prophylactic antibiotic treatment is also required, after excluding the presence of viral and fungal disease.
CONTRAINDICATIONS:
In patients with a history of hypersensitivity to betamethasone, or any excipient of the preparation.
Bacterial, viral, fungal, tuberculous or purulent conditions of the eye. Use is contraindicated if glaucoma is present, or where herpetic keratitis (e.g. dendritic ulcer) is considered a possibility. Use of topical steroids in the latter condition can lead to an extension of the ulcer and marked visual deterioration.
SPECIAL PRECAUTIONS AND WARNINGS for Methapyx N -Betnesol-N Eye/Ear Drops:
Topical corticosteroids should never be given for an undiagnosed red eye as inappropriate use is potentially blinding. Long-term intensive topical use may lead to systemic effects.
If there is no clinical response within 7 days of treatment, the drops should be discontinued Prolonged use may lead to the risk of adrenal suppression in infants.
Treatment with corticosteroid preparations should not be repeated or prolonged without regular review to exclude raised intraocular pressure, cataract formation or unsuspected infections. High-dose topical aminoglycoside antibiotics treatment to small children or infants may cause irreversible, partial or total deafness when given systemically or when applied topically to open wounds or damaged skin. This effect is dose-related and is enhanced by renal or hepatic impairment.
Pregnancy and Lactation: It should only be used when considered essential by a physician and only if the anticipated benefit outweighs the potential risk of foetal ototoxicity when aminoglycoside antibiotic preparations are administered during pregnancy.
DOSAGE AND DIRECTIONS FOR USE of Methapyx N -Betnesol-N Eye/Ear Drops:
For topical ophthalmic use only.
In adults & children, 1 or 2 drops are applied to each affected eye up to six times daily up to 7 days depending on clinical response.
If there is no clinical response within 7 days of treatment, discontinued the treatment. Treatment should be the lowest effective dose for the shortest possible time.
ADVERSE EFFECTS:
Delayed-type hypersensitivity reactions may occur leading to irritation, burning, stinging, itching and dermatitis. Topical corticosteroid use may result in corneal ulceration, increased intraocular pressure leading to optic nerve damage, reduced visual acuity and visual field defects. Intensive or prolonged use of topical corticosteroids may lead to the formation of posterior subcapsular cataracts. Very rarely, corneal calcification with the use of phosphate-containing eye drops.
In those diseases causing thinning of the cornea or sclera, corticosteroid therapy may result in thinning of the globe leading to perforation.
Mydriasis, ptosis, epithelial punctate keratitis and glaucoma have also been reported following the ophthalmic use of corticosteroids.
DRUG INTERACTIONS:
Because of the benzalkonium chloride used as a preservative, Betamethasone Eye Drops should not be used to treat patients who wear soft contact lenses.
OVERDOSAGE:
Treatment with higher than recommended doses may result in clinically significant adrenal suppression.
PRESENTATION:
Dropper Bottle Pack.
STORAGE INSTRUCTIONS:
Store below 30°C. Protect from light. Do not freeze.
Marketed by:
PYXUS PHARMACEUTICALS PVT. LTD.