LOTEMAX GEL

البلد: إسرائيل

اللغة: الإنجليزية

المصدر: Ministry of Health

العنصر النشط:

LOTEPREDNOL ETABONATE

متاح من:

TEVA ISRAEL LTD

ATC رمز:

S01BA14

الشكل الصيدلاني:

OPHTHALMIC GEL

تركيب:

LOTEPREDNOL ETABONATE 5 MG / 1 G

طريقة التعاطي:

OCULAR

نوع الوصفة الطبية :

Required

المصنعة من قبل:

BAUSCH & LOMB INCORPORATED, USA

المجال العلاجي:

LOTEPREDNOL

الخصائص العلاجية:

LOTEMAX® is a corticosteroid indicated for the treatment of post-operative inflammation and pain following ocular surgery.

تاريخ الترخيص:

2022-08-31

نشرة المعلومات

Be sure that the tip of the bottle does not come
into contact with any surface, including with
the finger or the eye and close the bottle tightly
after use.
This medicine is not intended for use in children
and infants.
DO NOT EXCEED THE RECOMMENDED DOSE.
If you are using Lotemax for 10 days or more,
intraocular pressure should be monitored.
Use this medicine at specified times, as
determined by the attending doctor.
IF YOU ACCIDENTALLY TOOK AN OVERDOSE 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, DO NOT STOP TREATMENT BEFORE
CONSULTING A DOCTOR.
HOW CAN YOU CONTRIBUTE TO THE SUCCESS OF
THE TREATMENT?
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 this 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.
THE MOST COMMON SIDE EFFECTS
∙ Inflammation of the iris
∙ Ocular pain
∙ Sensation of a foreign object in the eye.
ADDITIONAL SIDE EFFECTS
Upon use of corticosteroids for ocular treatment,
the following side effects may occur:
∙ Increased intraocular pressure (glaucoma)
∙ Damage to the optic nerve
∙ Defects in visual acuity and visual fields
∙ Cataract formation
∙ Secondary ocular infections, such as herpes
simplex
∙ Perforation of the cornea in areas where the
cornea is thinner due to disease.
IF A SIDE EFFECT OCCURS, IF ANY OF THE SIDE
EFFECTS WORSEN, OR IF YOU ARE SUFFERING FROM
A SIDE EFFECT N

خصائص المنتج

LOTEMAX- GEL SPC Notification N.A. 07.2022
SUMMARY OF PRODUCT CHARACTERISTICS
1. NAME OF THE MEDICINAL PRODUCT
LOTEMAX
®
GEL
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ml of the gel contains 5 mg of Loteprednol etabonate (0.5%,
5mg/ml).
Excipient with known effect
::
Each 1 gram of gel contains
0.06 mg of Benzalkonium chloride
0.003%
For the full list of excipients, see section 9.
Sterile preserved ophthalmic gel, white to off-white
3.
INDICATIONS AND USAGE
LOTEMAX GEL is a corticosteroid indicated for the treatment of
postoperative inflammation
and pain following ocular surgery.
4.
DOSAGE AND ADMINISTRATION

LOTEMAX Gel (loteprednol etabonate ophthalmic gel) is a sterile
preserved ophthalmic gel
containing 5 mg of loteprednol etabonate per gram of gel.

Invert closed bottle and shake once to fill tip before instilling
drops.

Apply one to two drops of LOTEMAX GEL into the conjunctival sac of the
affected eye
four times daily beginning the day after surgery and continuing
throughout the first 2
weeks of the postoperative period.
5.
CONTRAINDICATIONS
Hypersensitivity to active substance or any of the excipient listed in
section 9.
LOTEMAX GEL, , is contraindicated in most viral diseases of the cornea
and conjunctiva
including epithelial herpes simplex keratitis (dendritic keratitis),
vaccinia, and varicella, in
mycobacterial infection of the eye and fungal diseases of ocular
structures.
6.
WARNINGS AND PRECAUTIONS
6.1
Intraocular Pressure (IOP) Increase
Prolonged use of corticosteroids, including LOTEMAX, may result in
glaucoma with damage
to the optic nerve, defects in visual acuity and fields of vision.
Steroids should be used with
caution in the presence of glaucoma. If this product is used for 10
days or longer, intraocular
pressure should be monitored.
6.2
Cataracts
Use of corticosteroids may result in posterior subcapsular cataract
formation.
6.3
Delayed Healing
The use of steroids after cataract surgery may delay healing and
increase the incidence of bleb
formation. In those diseases causing