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TRAZYL®
1% Eyewash
TRAZYL® 2% Eyewash
S01FB03 – IBOPAMINE HYDROCHLORIDE
COMPOSITION
Eyewash 1% - Each bottle of lyophilized product
contains: Active substance: Ibopamine hydrochloride 50 mg - Excipient:
Mannitol
Each bottle of solvent contains: Benzalkonium chloride –
Hydroxypropylmethylcellulose – Citric acid monohydrate – Dibasic
sodium phosphate dihydrate - Water for injectable preparations.
Eyewash 2% - Each bottle of lyophilized product
contains: Active substance: Ibopamine hydrochloride 100 mg - Excipient:
Mannitol
Each bottle of solvent contains: Benzalkonium chloride –
Hydroxypropylmethylcellulose – Citric acid monohydrate – Dibasic
sodium phosphate dihydrate - Water for injectable preparations.
PHARMACEUTICAL
FORM
Eyewash:
lyophilized product + solvent
- 5-ml bottle of lyophilized eyewash 1% + 5-ml bottle of solvent
- 5-ml bottle of lyophilized eyewash 2% + 5-ml bottle of solvent
PHARMACOTHERAPEUTIC
GROUP
Non-cycloplegic mydriatic.
MARKETING
AUTHORIZATION HOLDER
Aziende Chimiche Riunite Angelini Francesco
A.C.R.A.F. S.p.A.
Viale Amelia 70 – 00181 Rome
MANUFACTURER
A.C.R.A.F. S.p.A. Via Vecchia del Pinocchio, 22 – 60 131 Ancona
Partial manufacturing: Pharminvest S.p.A. – Via Noto, 7 - Milan
THERAPEUTIC
INDICATIONS
Ibopamine eyewash is indicated for:
-
mydriasis diagnostics: eyeground and peripheral retina examination,
fluorangiography;
-
pre-surgery mydriasis
-
post-surgery mydriasis in order to prevent formation of synechias;
-
provocative test in glaucoma diagnostics;
-
treatment for post-surgical ocular hypotony.
CONTRAINDICATIONS
Closed- or narrow-angle glaucoma. Hypersensitivity towards any of the
product constituents or strictly related chemical substances.
SPECIAL
PRECAUTIONS FOR USE
The eyewash
does not cause changes in intraocular pressure of subjects with healthy
eyes. In patients with open-angle glaucoma, the product instillation causes
increased ocular pressure (IOP). In eyes with borderline IOP and glaucoma
with no hypertension, the medication may increase the ocular pressure
and reveal decreased outflow facility.
The product hypertensive action is independent of the mydriatic effect.
Being the ocular hypertensive effect short-lived and spontaneously reversible
(it recovers within 180 minutes), there are no contraindications to use
of the medicinal product in these groups of patients for diagnostic purposes
or in the post-surgery period, provided the treatment is always performed
under close medical surveillance.
Pregnancy
and lactation
In pre-clinical studies, the medication did not cause anomalies in the
normal fetal development; however, in exposed or presumed pregnancy or
in lactation, it is advisable for the product to be used under close medical
surveillance.
INTERACTION
WITH OTHER MEDICINAL PRODUCTS AND OTHER FORMS OF INTERACTION
To date, no forms of interaction are known in case of local ocular application
according to the relevant indications.
SPECIAL
WARNINGS
In order to
prevent dilution of the active substance, a 5-minute interval should be
observed in between applications.
Do not apply the product just before driving or using machines.
Keep the product out of the reach of children.
POSOLOGY
AND METHOD OF ADMINISTRATION
In man, ibopamine
eyewash should be used according to the following posology:
- Mydriasis diagnostics:
-
Adults: the dose recommended for ibopamine 2% is 1 to 2 drops.
-
Babies and pediatric patients: the dose recommended for ibopamine 1%
is 2 drops.
Pre-surgery mydriasis: in cases of cataract extraction under
local anesthesia, ibopamine 2% may be used alone as the only dilating
treatment, or combined with other mydriatic agents having different action
mechanisms, and should be administered according to the following posologic
regimen: 1 or 2 drops 60, 30 and 5 minutes prior to surgery. If the cataract
extracapsular extraction is carried out under general anesthesia, ibopamine
2% should be administered combined with one or more mydriatic agents having
different action mechanisms, like parasympathicolytics such as tripicamide.
Post-surgery mydriasis: 1 drop of ibopamine 1% or 2% 2 to 4 times
daily for 4-6 days following surgery.
Provocative test in glaucoma diagnostics: the ibopamine test
should be performed administering 2-drop doses of eyewash 2% at 5-minute
intervals and comparing the intraocular pressure measured 45 minutes after
the instillation to the baseline values for this parameter. Where detected,
any ocular hypertension reveals decreased outflow facility.
Treatment for post-surgical hypotony: fluorophotometry studies
demonstrated that, owing to activation of ciliary body D1 dopaminergic
receptors, the instilled ibopamine can stimulate increased production
of aqueous humor.
In that case, the medication may be administered 6 to 8 times daily, according
to clinical needs.
DIRECTIONS
FOR USE
1.
Open the glass bottle containing the lyophilized product; pressing the
plastic bottle, pour the solvent contained into the glass bottle.
2. Seal back the glass bottle using the rubber top and shake.
3. Remove the rubber top and fit the dropper contained in the separate
bag onto the glass bottle.
4. Remove the dropper top and instill.
OVERDOSE
In case of
overdose, which may show by increase in the local undesirable effects
listed above, discontinue the treatment.
Mydriasis reversion may be obtained by administering eyewashes containing
a-blocking substances.
Where present, any local sign and symptom may be controlled by local symptomatic
treatment.
UNDESIRABLE
EFFECTS
Events such as burning sensation and, less commonly, conjunctival hyperemia
and lacrimation have been reported following instillation of the eyewash.
They showed to be mild, transitory and always spontaneously reversible.
Occurrence of palpebral edge ischemia is possible in newborn patients;
this event is commonly observed in cases of topical treatment with sympathomimetic
agents and reverts spontaneously.
Report any undesirable effect not listed in the explanatory leaflet to
your Doctor or Pharmacist.
SHELF
LIFE
Warning: do
not use the medicinal product after the expiry date shown on the package.
After opening the package and reconstituting the solution, the ready-for-use
eyewash, kept refrigerated between +2° and +8°C, may be used for
no longer than 20 days.
Seal back the bottle immediately after each application.
DATE
OF LAST REVISION OF THE TEXT: June 13, 1997
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