MAXITROL OPHTHALMIC SUSPENSION

Country: Israel

Language: English

Source: Ministry of Health

Active ingredient:

DEXAMETHASONE; NEOMYCIN AS SULFATE; POLYMYXIN B SULFATE

Available from:

NOVARTIS ISRAEL LTD

ATC code:

S01AA18

Pharmaceutical form:

OPHTHALMIC SUSPENSION

Composition:

DEXAMETHASONE 1.0 MG/ML; NEOMYCIN AS SULFATE 3,500 IU/ML; POLYMYXIN B SULFATE 6000 IU/ML

Administration route:

OCULAR

Prescription type:

Required

Manufactured by:

ALCON COUVREUR, BELGIUM

Therapeutic group:

POLYMYXIN B

Therapeutic area:

POLYMYXIN B

Therapeutic indications:

Maxitrol is indicated in ocular inflammation when concurrent use of antimicrobial in judged necessary.

Authorization date:

2014-09-30

Patient Information leaflet

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Summary of Product characteristics

UK SmPC (JAN 2021)
MAX DRO API MAY21 V5
SUMMARY OF PRODUCT CHARACTERISTICS
1. NAME OF THE MEDICINAL PRODUCT
Maxitrol ophthalmic suspension
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
1 ml suspension contains 1 mg dexamethasone, 3,500 I.U. neomycin
sulphate and 6,000 I.U.
polymyxin B sulphate.
Excipient(s) with known effect:
1 ml suspension contains 0.04 mg benzalkonium chloride.
For a full list of excipients, see section 6.1.
3. PHARMACEUTICAL FORM
Ophthalmic suspension
Opaque suspension, white to pale yellow, no agglomerates for topical
ocular administration.
4. CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Maxitrol ophthalmic suspension is indicated in ocular inflammation
when concurrent use of
antimicrobial in judged necessary.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
POSOLOGY:
1 to 2 drops topically in the conjunctival sac
In cases of acute disorder, drops may be instilled hourly, being
tapered to discontinuation as
the inflammation subsides. In mild disorders, instill 4 to 6 times
daily.
tic and renal impairment
Hepa
Maxitrol ophthalmic suspension has not been studied in these subject
populations.
However, due to low systemic absorption of the active substances after
topical
administration of this product, dose adjustment is not necessary.
METHOD OF ADMINISTRATION
For ocular use only. Not for injection or ingestion.
Shake the bottle well before use.
After cap is removed, if tamper evident snap collar is loose, remove
before using product.
In order to prevent contamination of the dropper tip and the
suspension, caution should be
exercised to ensure that the dropper tip does not touch the eyelids,
the surroundings of the
eye, or any other surfaces.
Nasolacrimal occlusion or gently closing the eyelid after
administration is recommended.
This may reduce the systemic absorption of medicinal products
administered via the ocular
route and result in a decrease in systemic adverse reactions.
4.3 CONTRAINDICATIONS
•
Hypersensitivity to the active substances or to any of the excipients
listed in section 6.1.
•