Brimonidine Indoco

Country: New Zealand

Language: English

Source: Medsafe (Medicines Safety Authority)

Active ingredient:

Brimonidine tartrate 2 mg/mL equivalent to brimonidine 1.3 mg/mL

Available from:

Miro Healthcare Limited

Dosage:

2 mg/mL

Pharmaceutical form:

Eye drops, solution

Composition:

Active: Brimonidine tartrate 2 mg/mL equivalent to brimonidine 1.3 mg/mL Excipient: Benzalkonium chloride Citric acid monohydrate Hydrochloric acid Polyvinyl alcohol Sodium chloride Sodium citrate Sodium hydroxide Water for injection

Prescription type:

Prescription

Therapeutic indications:

Indicated for lowering intraocular pressure in patients with chronic open-angle glaucoma or ocular hypertension.

Product summary:

Package - Contents - Shelf Life: Bottle, plastic, LDPE bottle with natural LDPE nozzle and purple HDPE cap 10 mL - 1 bottles - 36 months from date of manufacture stored at or below 25°C 28 days opened stored at or below 25°C - Bottle, plastic, LDPE bottle with natural LDPE nozzle and purple HDPE cap 5 mL - 1 bottles - 36 months from date of manufacture stored at or below 25°C 28 days opened stored at or below 25°C - Bottle, plastic, LDPE bottle with natural LDPE nozzle and purple HDPE cap 2.5 mL - 1 bottles - 36 months from date of manufacture stored at or below 25°C 28 days opened stored at or below 25°C - Bottle, plastic, LDPE bottle with natural LDPE nozzle and purple HDPE cap 10 mL - 3 bottles - 36 months from date of manufacture stored at or below 25°C 28 days opened stored at or below 25°C - Bottle, plastic, LDPE bottle with natural LDPE nozzle and purple HDPE cap 5 mL - 3 bottles - 36 months from date of manufacture stored at or below 25°C 28 days opened stored at or below 25°C - Bottle, plastic, LDPE bottle with natural LDPE nozzle and purple HDPE cap 2.5 mL - 3 bottles - 36 months from date of manufacture stored at or below 25°C 28 days opened stored at or below 25°C - Bottle, plastic, LDPE bottle with natural LDPE nozzle and purple HDPE cap 10 mL - 6 bottles - 36 months from date of manufacture stored at or below 25°C 28 days opened stored at or below 25°C - Bottle, plastic, LDPE bottle with natural LDPE nozzle and purple HDPE cap 5 mL - 6 bottles - 36 months from date of manufacture stored at or below 25°C 28 days opened stored at or below 25°C - Bottle, plastic, LDPE bottle with natural LDPE nozzle and purple HDPE cap 2.5 mL - 6 bottles - 36 months from date of manufacture stored at or below 25°C 28 days opened stored at or below 25°C

Authorization date:

2021-01-23

Summary of Product characteristics

NEW ZEALAND DATA SHEET
1.
PRODUCT NAME
Brimonidine Indoco
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each mL of Brimonidine Indoco
eye drops contains brimondine tartrate Ph.Eur. 2.0mg
equivalent to 1.3mg of Brimonidine
For the full list of excipients, see Section 6.1.
3.
PHARMACEUTICAL FORM
Sterile ophthalmic solution.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Brimonidine Indoco
eye drops are effective for lowering intraocular pressure in patients
with
chronic open-angle glaucoma or ocular hypertension.
4.2
DOSAGE AND METHOD OF ADMINISTRATION
The recommended dose is one drop of Brimonidine Indoco
eye drops in the affected
eye(s)
twice daily, approximately 12 hours apart.
If more than one topical ophthalmic medicine is to be used, other eye
drops should
not
be used within five to ten minutes of using Brimonidine Indoco
eye drops.
In order to minimise systemic absorption of Brimonidine Indoco
eye drops, apply
pressure
to the tear duct immediately following administration.
_PAEDIATRIC USE_
_ _
Symptoms of bradycardia, coma hypotension, lethargy, pallor,
respiratory,
depression,
somnolence, hypothermia, hypotonia and apnea have been reported) in
neonates,
infants and children receiving brimonidine either for congenital
glaucoma
or by
accidental oral ingestion. Also see 4.3 Contraindications section.
4.3
CONTRAINDICATIONS
Brimonidine Indoco eye drops are contraindicated in patients with
hypersensitivity to
brimonidine tartrate or any of the excipients listed in section 6.1.
Brimonidine indoco
is
also
contraindicated in patients receiving monoamine oxidase (MAO)
inhibitor therapy.
Brimonidine Indoco eye drops are also contraindicated in neonates and
infants (children
under the age of 2 years)
4.4
SPECIAL WARNINGS AND PRECAUTIONS FOR USE
Children 2 years of age and above, especially those weighing ≤ 20
kg, should be
treated
with
caution
and
closely
monitored
due
to
the
high
incidence
and
severity
of
somnolence (see Paediatric Use).
Although Brimonidine Indoco eye drops had minimal effect on blood
pressure a