LOTEMAX SUSPENSION

البلد: إسرائيل

اللغة: الإنجليزية

المصدر: Ministry of Health

العنصر النشط:

LOTEPREDNOL ETABONATE

متاح من:

ABIC MARKETING LTD, ISRAEL

ATC رمز:

S01BA14

الشكل الصيدلاني:

OPHTHALMIC SUSPENSION

تركيب:

LOTEPREDNOL ETABONATE 5 MG / 1 ML

طريقة التعاطي:

OCULAR

نوع الوصفة الطبية :

Required

المصنعة من قبل:

BAUSCH & LOMB INCORPORATED, USA

المجموعة العلاجية:

LOTEPREDNOL

المجال العلاجي:

LOTEPREDNOL

الخصائص العلاجية:

Lotemax is indicated for the treatment of steroid responsive inflammatory conditions of the palpebral and bulbar conjunctiva, cornea and anterior segment of the globe such as allergic conjunctivitis, acne rosacea, superficial punctate keratitis, herpes zoster keratitis, iritis, cyclitis, selected infective conjunctivitides, when the inherent hazard of steroid use is accepted to otain an advisable diminution in edema and inflammation. Lotemax is less effective than prednisolone acetate 1 % in two 28 day controlled clinical studies in acute anterior uveitis, where 72 % of patients treated with Lotemax experienced resolution of anterior chamber cells, compared to 87 % of patients treated with prednisolone acetate 1 % . The incidence of patients with clinically significant increases in IOP (> or = 10 mmHg) was 1 % with Lotemax adn 6 % with prednisolone acetate 1 %. Lotemax should not be used in patients who require a more potent corticosteroid for this indication. Lotemax is also indicated for the treatment of post - operative inflammation following ocular surgery.

تاريخ الترخيص:

2014-10-31

نشرة المعلومات

Part # / SPEC#: 9633701 (L-500346) / 9632901 (L-500347)
DESCRIPTION:
Lotemax Israel Insert
- COLORS: Black
SPECIAL INSTRUCTIONS:
Q SCANNER BAR LOCATION:NA
QDIELINE DOES NOT PRINT
QCOATING PER SPECIFICATION
PRINTED BARCODES MUST BE VERIFIED READABLE AND ACCURATE
BY VENDOR TO THE HUMAN READABLE INDICATED ON ARTWORK.
BAUSCH & LOMB, 1400 N. GOODMAN ST.
ROCHESTER,
/:




t
FAX: [phone]
This medicine is not intended for use in children
and infants.
DO NOT EXCEED THE RECOMMENDED DOSE.
If there is no improvement in your condition
within two days, refer to the doctor.
The doctor
may want to reevaluate your condition.
If you are using Lotemax Suspension for 10
days or more, intraocular pressure should be
monitored.
Use this medicine at specified time intervals, as
determined by the attending doctor.
IF YOU ACCIDENTALLY TOOK A HIGHER DOSAGE OF THE
MEDICINE, OR IF A CHILD ACCIDENTALLY SWALLOWED
THE MEDICINE, immediately refer to a doctor or
proceed to a hospital emergency room and bring
the package of the medicine with you.
IF YOU FORGOT TO TAKE THE MEDICINE
If you forgot to take this medicine at the
scheduled time, take a dose as soon as you
remember, but never take two doses together.
Adhere to the treatment as recommended by
the doctor.
Even if there is an improvement in your health
condition, do not stop treatment before
consulting a doctor.
DO NOT TAKE MEDICINES IN THE DARK! CHECK THE
LABEL AND DOSE EACH TIME YOU TAKE MEDICINE.
WEAR GLASSES IF YOU NEED THEM.
IF YOU HAVE FURTHER QUESTIONS REGARDING
USE OF THE MEDICINE, CONSULT THE DOCTOR OR
PHARMACIST.
4. SIDE EFFECTS
As with any medicine, use of the preparation
may cause side effects in some users. Do not
be alarmed when reading the list of side effects.
You may not suffer from any of them.
REFER TO A DOCTOR IMMEDIATELY IF SOME OF THE
FOLLOWING SIDE EFFECTS OCCUR:
∙ Blurred vision or any change in vision
∙ Redness or swelling of the eye
∙ Conjunctival edema (swelling of the membrane
covering the white part of the eye)
∙ Ocular discharge

خصائص المنتج

LOTEMAX Suspension – Ophthalmic Suspension - 0.5% - Minor Updates
SPC – 10-2021 - ME
PHYSICIANS’ PRESCRIBING INFORMATION
LOTEMAX SUSPENSION
Ophthalmic Suspension
Rx only
DESCRIPTION:
LOTEMAX
®
(loteprednol etabonate ophthalmic suspension) contains a sterile,
topical anti-
inflammatory corticosteroid for ophthalmic use. Loteprednol etabonate
is a white to off-white
powder.
Loteprednol etabonate is represented by the following structural
formula:
C
24
H
31
ClO7
HO
O
C = O
OCH
2
Cl
OCO
2
C
2
H
5
Mol. Wt. 466.96
Chemical Name:
chloromethyl 17
α
-[(ethoxycarbonyl)oxy]-11
β
-hydroxy-3-oxoandrosta-1,4-diene-17
β
-carboxylate
Each mL contains:
ACTIVE: Loteprednol Etabonate 5 mg (0.5%);
INACTIVES: Edetate Disodium, Glycerin, Povidone, Purified Water and
Tyloxapol. Hydrochloric
Acid and/or Sodium Hydroxide may be added to adjust the pH to 5.5-5.6.
The suspension is
essentially isotonic with a tonicity of 250 to 310 mOsmol/kg.
PRESERVATIVE ADDED: Benzalkonium Chloride 0.01%.
CLINICAL PHARMACOLOGY:
Corticosteroids inhibit the inflammatory response to a variety of
inciting agents and probably
delay or slow healing. They inhibit the edema, fibrin deposition,
capillary dilation, leukocyte
migration,
capillary
proliferation,
fibroblast
proliferation,
deposition
of
collagen,
and
scar
formation associated with inflammation. There is no generally accepted
explanation for the
mechanism of action of ocular corticosteroids. However,
corticosteroids are thought to act by
the
induction
of
phospholipase
A
2
inhibitory
proteins,
collectively
called
lipocortins.
It
is
postulated that these proteins control the biosynthesis of potent
mediators of inflammation such
as
prostaglandins
and
leukotrienes
by
inhibiting
the
release
of
their
common
precursor
arachidonic acid. Arachidonic acid is released from membrane
phospholipids by phospholipase
A
2
. Corticosteroids are capable of producing a rise in intraocular
pressure.
Loteprednol etabonate is structurally similar to other
corticosteroids. However, the number
20 position ketone grou