INDICATIONS     CONTRA-INDICATIONS     DOSAGE     SIDE-EFFECTS     PREGNANCY     OVERDOSE     IDENTIFICATION     PATIENT INFORMATION

Logo ALPHAGAN® Purite® Ophthalmic solution

SCHEDULING STATUS
Schedule 3

PROPRIETARY NAME
(and dosage form)

ALPHAGAN® Purite® Ophthalmic solution

COMPOSITION
Each mL contains: Brimonidine tartrate 1,5 mg
Excipients: Boric acid, calcium chloride dehydrate, magnesium chloride hexahydrate; potassium chloride, purified water, sodium borate decahydrate, sodium carboxymethylcellulose, sodium chloride.
Preservative: Purite
® (stabilised oxychloro complex) 0,005% m/v

PHARMACOLOGICAL CLASSIFICATION
Pharmacodynamic properties
Brimonidine tartrate is a selective alpha-2-adrenergic receptor agonist. Topical administration of brimonidine decreases intraocular pressure (IOP) in humans with a peak ocular hypotensive effect occurring at two hours post-dosing. Fluorophotometric studies in animals and humans suggest that brimonidine tartrate has a dual mechanism of action by reducing aqueous humour production and increasing uveoscleral outflow.
Pharmacokinetic properties
Absorption
After ocular administration of either a 0,1% or 0,2% solution, plasma concentrations peaked within 0,5 to 2,5 hours and declined with a systemic half-life of approximately 2 hours.
Distribution
The protein binding of brimonidine has not been studied.
Metabolism
In humans brimonidine is extensively metabolised by the liver.
Elimination
Urinary excretion is the major route of elimination of the medicine and its metabolites. Approximately 87% of an orally-administered radioactive dose was eliminated within 120 hours, with 74% found in the urine.

INDICATIONS
ALPHAGAN
® Purite® is indicated for the lowering of intraocular pressure in patients with open-angle glaucoma or ocular hypertension.

CONTRA-INDICATIONS
ALPHAGAN
® Purite® is contraindicated in patients who have exhibited a hypersensitivity reaction to brimonidine tartrate or any component of ALPHAGAN® Purite®.
ALPHAGAN
® Purite® is contraindicated in neonates and infants (under the age of 2 years).

WARNINGS AND SPECIAL PRECAUTIONS
Severe Cardiovascular Disease
Although ALPHAGAN® Purite® ophthalmic solution had minimal effects on the blood pressure of patients in clinical studies, caution should be exercised in treating patients with severe cardiovascular disease.
Potentiation of Vascular Insufficiency
ALPHAGAN® Purite® may potentiate syndromes associated with vascular insufficiency. ALPHAGAN® Purite® should be used with caution in patients with depression, cerebral or coronary insufficiency, Raynaud’s phenomenon, orthostatic hypotension, or thromboangiitis obliterans. Patients using IOP-lowering medication should be routinely monitored for IOP.
Contamination of ALPHAGAN® Purite® After Use
There have been reports of bacterial keratitis associated with the use of multiple-dose containers of topical ophthalmic products such as ALPHAGAN® Purite®. These containers had been inadvertently contaminated by patients who, in most cases, had a concurrent corneal disease or a disruption of the ocular epithelial surface (see “Information for patients”).
Paediatric use
ALPHAGAN® Purite® is contra-indicated in children under the age of 2 years (see “Contraindications”). The safety and efficacy of brimonidine tartrate have not been studied in children below the age of 2 years. During post-marketing surveillance, apnoea, bradycardia, coma, hypotension, hypothermia, hypotonia, lethargy, pallor, respiratory depression, and somnolence have been reported in infants receiving brimonidine.
In a clinical study conducted in paediatric glaucoma patients (ages 2 to 7 years) the most commonly observed adverse reactions with brimonidine tartrate ophthalmic solution 0,2% dosed three times daily were somnolence (50 - 83% in patients ages 2 to 6 years) and decreased alertness. In paediatric patients 7 years of age (>20 kg), somnolence appears to occur less frequently (25%).
Approximately 16% of patients on brimonidine tartrate ophthalmic solution discontinued from the study due to somnolence.
Geriatric use
No overall differences in safety or efficacy have been observed between elderly and other adult patients.
Special populations
ALPHAGAN® Purite® has not been studied in patients with hepatic impairment.
ALPHAGAN
® Purite® has not been studied in patients with renal impairment. The effect of dialysis on brimonidine pharmacokinetics in patients with renal failure is not known.
Information for patients
Patients should be instructed that ocular solutions, if handled improperly or if the tip of the dispensing container contacts the eye or surrounding structures, can become contaminated by common bacteria known to cause ocular infections. Serious damage to the eye and subsequent loss of vision may result from using contaminated solutions. Always replace the cap after using. If solution changes colour or becomes cloudy, do not use. Do not use the product after the expiration date marked on the bottle.
Patients also should be advised that if they have ocular surgery or develop an intercurrent ocular condition (e.g. trauma or infection), they should immediately seek their doctor’s advice concerning the continued use of the present multidose container.
If more than one topical ophthalmic medicine is being used, the medicine should be administered at least five minutes apart.

Effects on ability to drive and use machines
ALPHAGAN
® Purite® may cause fatigue and/or drowsiness in some patients. Patients who engage in hazardous activities should be cautioned of the potential for a decrease in mental alertness.

INTERACTIONS
Antihypertensives
Because ALPHAGAN® Purite® may reduce blood pressure, caution in using antihypertensives with ALPHAGAN® Purite® is advised.
Digoxin
Caution is advised when using ALPHAGAN® Purite® with digoxin.
CNS depressants
Although specific interaction studies have not been conducted with ALPHAGAN® Purite®, the possibility of an additive or potentiating effect with CNS-depressants (alcohol, barbiturates, opiates, sedatives, or anaesthetics) should be considered.
Alpha-agonists, as a class, may reduce pulse and blood pressure. Caution in using concomitant medicines such as beta-blockers (ophthalmic and systemic), anti-hypertensives and/or digoxin is advised.
Tricyclic antidepressants
Tricyclic antidepressants have been reported to blunt the hypotensive effects of systemic clonidine. It is not known whether the concurrent use of these agents with ALPHAGAN® Purite® ophthalmic solution in humans can lead to resulting interference with the IOP lowering effect. Caution is advised in patients taking tricyclic antidepressants which can affect the metabolism and uptake of circulating amines.
Monoamine oxidase inhibitors
Monoamine oxidase (MAO) inhibitors may interfere with the metabolism of ALPHAGAN® Purite® and potentially result in an increased systemic side-effect such as hypotension. Caution is advised in patients taking MAO inhibitors which can affect the metabolism and uptake of circulating amines.

PREGNANCY AND LACTATION
Pregnancy
Safety and/or efficacy for ALPHAGAN
® Purite® use during pregnancy have not been established.
Lactation
It is not known whether ALPHAGAN
® Purite® is excreted in breastmilk. Because of the potential for serious adverse reactions from ALPHAGAN® Purite® in nursing infants, patients should not breastfeed while using ALPHAGAN® Purite®.

DOSAGE AND DIRECTIONS FOR USE
The recommended dose is one drop of ALPHAGAN
® Purite® in the affected eye(s) twice daily, approximately 12 hours apart.
ALPHAGAN
® Purite® ophthalmic solution may be used concomitantly with other topical ophthalmic medicinal products to lower intraocular pressure. If more than one topical ophthalmic product is being used, the product should be administered at least 5 minutes apart.

SIDE EFFECTS
For each indication the frequency of adverse reactions arising from clinical experience is given as follows: Very common (>1/10); Common >1/100, <1/10); Uncommon (>1/1 000, <1/100); Rare (>1/10 000, <1/1 000); Very rare (<1/10 000).
Eye disorders
Very common: Allergic conjunctivitis, conjunctival hypaeremia, eye pruritus
Common: Blepharitis, burning sensation, conjunctival folliculosis, conjunctival oedema, conjunctival haemorrhage, conjunctivitis, epiphora, eye discharge, eye dryness, eye irritation, eye pain, follicular conjunctivitis, foreign body sensation, photophobia, stinging, superficial punctuate keratophy, visual disturbance, visual field defects, vitreous floaters, worsened visual acuity, blepharoconjunctivitis, blurred vision, cataract, keratitis, lid disorder, tearing, vitreous detachment, vitreous disorder, ocular allergic reaction, eyelid oedema, eyelid erythema
Uncommon: Corneal erosion, hordeolum
Nervous system disorders
Common: Dizziness, headache
Uncommon: Somnolence, taste perversion
Vascular disorders
Common: Hypertension, hypotension
Psychiatric disorders
Uncommon: Insomnia
Respiratory, thoracic and mediastinal disorders
Common: Cough, dyspnoea
Uncommon: Nasal dryness
Gastrointestinal disorders
Common: Dyspepsia, oral dryness, gastrointestinal disorder
Skin and subcutaneous tissue disorders
Common: Rash
Immune system disorders
Common: Allergic reaction
Infections and infestations
Common: Bronchitis, flu syndrome, pharyngitis, rhinitis, sinus infection, sinusitis
General disorders and administration site conditions
Common: Asthenia, fatigue
Blood and lymphatic system disorders
Common: Hypercholesterolaemia

The following events have been identified during post-marketing use of ALPHAGAN
® Purite® ophthalmic solution in clinical practice. Because they are reported voluntarily from a population of unknown size, estimates of frequency cannot be made. The events, which have been chosen for inclusion due to either their seriousness, frequency of reporting, possible causal connection to ALPHAGAN® Purite®, or a combination of these factors, include: bradycardia, depression, hypersensitivity, iritis, keratoconjunctivitis sicca, miosis, nausea, skin reactions (including erythema, eyelid pruritus, rash and vasodilatation), syncope, and tachycardia.

KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT
Very limited information exists on accidental ingestion of brimonidine in adults and children; the only adverse reaction reported to date has been hypotension. Treatment of an oral overdose includes supportive and symptomatic therapy; a patient airway should be maintained.

IDENTIFICATION
Clear green-yellow solution, essentially free of any visible particulate matter.

PRESENTATION
ALPHAGAN
® Purite® is supplied sterile in opaque teal LDPE plastic bottles and tips with purple high impact polystyrene (HIPS) caps, containing 5 mL, 10 mL or 15 mL of solution.

STORAGE INSTRUCTIONS
Store at or below 25ºC and protect from light. To avoid contamination of the solution keep container tightly closed. Do not touch dropper tip to any surface. Discard contents 30 days after opening the bottle. Contents are sterile if seal is intact.
KEEP OUT OF REACH AND SIGHT OF CHILDREN.

REGISTRATION NUMBER
A39/15.4/0202

NAME AND BUSINESS ADDRESS OF THE HOLDER OF THE CERTIFICATE OF REGISTRATION
Allergan Pharmaceuticals (Pty) Ltd
30 New Road (entrance off Bavaria Road)
Randjespark Ext. 11, Midrand, 1682
Johannesburg, Gauteng
South Africa

DATE OF PUBLICATION OF THE PACKAGE INSERT
Date of registration: 5 October 2007
Date of revision of the package insert: 02 October 2015

PATIENT INFORMATION LEAFLET

SCHEDULING STATUS
Schedule 3

PROPRIETARY NAME, STRENGTH AND PHARMACEUTICAL FORM

ALPHAGAN
® Purite®, brimonidine tartrate 1,5 mg/mL ophthalmic solution

Read all of this leaflet carefully before you start using ALPHAGAN
® Purite®
  Keep this leaflet. You may need to read it again.
If you have further questions, please ask your doctor or your pharmacist.
ALPHAGAN® Purite® has been prescribed for you personally and you should not share your medicine with other people. It may harm them, even if their symptoms are the same as yours.

1. WHAT ALPHAGAN
® PURITE® CONTAINS
The active substance is brimonidine tartrate
The other ingredients are boric acid, calcium chloride, magnesium chloride, potassium chloride, purified water, sodium borate, sodium carboxymethylcellulose, sodium chloride and Purite® (stabilised oxychloro complex) 0,005% m/v as preservative.

2. WHAT ALPHAGAN
® PURITE® IS USED FOR
ALPHAGAN
® Purite® ophthalmic solution helps fluid flow out of the eye chamber and also decreases the fluid produced by the eye. This lowers the pressure in the eye. ALPHAGAN® Purite® can be used either alone or with another eye drop which lowers pressure in the eye for the treatment of high pressure in the eye in glaucoma or ocular hypertension.

3. BEFORE YOU USE ALPHAGAN
® PURITE®
Do not use ALPHAGAN® Purite®
If you are hypersensitive (allergic) to brimonidine tartrate or any of the ingredients of ALPHAGAN® Purite®.
ALPHAGAN® Purite® should not be used in neonates and infants under the age of 2 years.

Take special care with ALPHAGAN
® Purite®
If you have any diseases associated with the heart.
If you have any diseases that affect the kidney or liver.
If you suffer or have suffered from depression, reduced mental capacity, reduced blood supply to the brain, Raynaud’s phenomenon (a condition resulting in painful discolouration of the fingers and/or the toes after exposure to changes in temperature or emotional events), or have very low blood pressure.
If you are scheduled to have surgery using a general anaesthetic.
If you are being treated with monoamine oxidase (MAO) inhibitors.

Pregnancy and breastfeeding
Safety and/or efficacy for ALPHAGAN
® Purite® use during pregnancy and breastfeeding have not been established.
If you are pregnant or breastfeeding your baby please consult your doctor, pharmacist or other health care professional for advice before using ALPHAGAN
® Purite®.

Driving and using machinery
Be careful driving a car or operating machinery until you know how ALPHAGAN
® Purite® ophthalmic solution affects you. It may make you drowsy.

Using other medicines with ALPHAGAN
® Purite®
Always tell your healthcare professional if you are taking any other medicine. (This includes complementary or traditional medicines.)
The following medicine should be used with caution:
Medicines used in the treatment of high blood pressure;
Digoxin, used in the treatment of congestive heart failure and cardiac dysrhythmia;
Beta-blockers (ophthalmic and systemic) e.g. atenolol, sotalol, timolol;
Tricyclic antidepressants e.g. amitriptyline, imipramine etc.;
Monoamine oxidase (MAO) inhibitors used in the treatment of depression e.g. moclobemide, selegiline etc.;
Alcohol, nervous system depressants, opiates, sedatives, or anaesthetics.

4. HOW TO USE ALPHAGAN
® PURITE®
Do not share medicines prescribed for you with any other person.
Always use ALPHAGAN
® Purite® exactly as your doctor has instructed you. You should check with your doctor or pharmacist if you are unsure.
The usual dose is one drop in the eye(s) every twelve hours.

Helpful hints:
Open the eye(s) needing the drops, tilt your head back and look upward
Gently pull down the lower eyelid
Bring the eye drops near the eye and squeeze one drop into the eye
Avoid touching the eye, eyelids or lashes with the dropper
Close your eyes and blink; this helps distribute the drops in the eye chamber
While your eyes are closed, gently press your fingers on the inner corner(s) of your eye(s)
Wipe any excess away with a clean tissue
Replace cap on the dropper bottle
Your doctor will tell you how long your treatment with ALPHAGAN® Purite® will last. Do not stop using ALPHAGAN® Purite® ophthalmic solution even if you feel well unless instructed by your doctor.
If you are under the impression that the effect of ALPHAGAN
® Purite® is too strong or too weak for you, tell your doctor or pharmacist.

Method of administration if you are using other medicines with ALPHAGAN
® Purite®
If you have glaucoma which is difficult to control, certain other medicines or drops may be added to the existing treatment with ALPHAGAN® Purite® ophthalmic solution.
The length of treatment with these eye drops depends on your condition, and will be determined by your doctor.
The dose of the eye drops may be changed by your doctor to best treat your condition.
If you use ALPHAGAN® Purite® ophthalmic solution with another eye medicine, apply ALPHAGAN® Purite® ophthalmic solution first and wait five minutes before applying the second eye medicine.

Use in children
ALPHAGAN
® Purite® should not be used in children below the age of 2 years.
Things to be careful of
Keep enough eye drops to last weekends and holidays.
If not handled properly, eye drops can become contaminated by germs which can cause eye infections. This may cause serious damage to your eye and loss of vision. To help prevent infections, do not let the tip of the bottle touch your eye or anything else. Put the cap back on and close the bottle straight after you have used it. Do not use if the solution changes colour or becomes cloudy. Do not use after the expiry date marked on the bottle.
Tell your doctor immediately if you develop an eye infection, if you hurt your eye, or if you have to go for an eye operation.

If you use more ALPHAGAN
® Purite® than you should
The eye(s) should be flushed with water. If you have questions or concerns, or are not sure about something, please consult your doctor or pharmacist.
In the event of overdosage, consult your doctor or pharmacist. If neither is available, contact the nearest hospital or poison control centre.

If you forget to use ALPHAGAN
® Purite®
Use the eye drops as soon as you remember, and then go back to using them as you would normally. If it is almost time for your next dose, ignore the dose you missed and put the drops in when you are meant to.
Do not take a double dose to make up for the dose that you missed. If you have missed several doses, consult your doctor. If you have trouble remembering when to use your medicine, ask your pharmacist for some hints.

Effects when treatment with ALPHAGAN
® Purite® is stopped
ALPHAGAN
® Purite® lowers pressure in your eye for the treatment of high pressure in the eye in glaucoma or ocular hypertension and if treatment is interrupted or stopped early your condition may return and have serious adverse effect.

5. POSSIBLE SIDE EFFECTS
ALPHAGAN
® Purite® can have side effects. Not all side effects reported for ALPHAGAN® Purite® are included in this leaflet. Should your general health worsen or if you experience any untoward effects while using ALPHAGAN® Purite®, please consult your doctor, pharmacist or other health care professional for advice.
Frequent side effects
High levels of cholesterol in the blood
Allergic reaction
Dizziness, headache
Eye allergy, red eye, itchy eyes, itchy eyelids, burning sensation (eyes), small bumps inside the eyelid, eye swelling, eye surface bleeding, eye surface inflammation, watery eyes, sticky eyes, dry eyes, eye irritation, eye pain, small bumps on the eye surface, a feeling that something in is your eye, light sensitivity, stinging, visual disturbance, abnormalities in the field of view, eye floaters, eye sight worsening, eyelid and eye surface irritations, blurred vision, cloudy lens inside the eye, inflammation of the central front part of the eye, eyelid abnormalities, tearing, separation of gel tissue in the eye, abnormal gel tissue in the eye
High blood pressure, low blood pressure
Cough, shortness of breath
Indigestion, dryness of the mouth, digestive disorder
Bronchitis, flu syndrome, pharyngitis (sore throat), runny nose, sinus infection, sinusitis, colds and respiratory infections
Feeling weak, tiredness

Less frequent side effects
Difficulty in sleeping, feeling drowsy
Distorted or abnormal sense of taste
Superficial damage to the front part of the eye, styes
Dryness of the nose
If you notice any side effects not mentioned in this leaflet, please inform your doctor or pharmacist.

6. STORING AND DISPOSING OF ALPHAGAN
® PURITE®
Store at or below 25ºC and protect from light.
Store all medicines out of reach of children.
The EXPIRY date is marked on the bottle. Do not use the ophthalmic solution beyond the expiry date. Throw out any unused drops 30 days after opening the bottle.
Store in the original eye drop bottle.
To avoid contamination of the solution, keep container tightly closed and do not touch dropper tip to any surface.
Contents are sterile if seal is intact.
Do not put the eye drops in the freezer.
Return all unused medicines to your pharmacist.
Do not dispose of unused medicines in drains or sewerage systems (e.g. toilets).

7. PRESENTATION OF ALPHAGAN
® PURITE®
ALPHAGAN® Purite® ophthalmic solution is supplied sterile in opaque teal plastic bottles and tips with purple caps, containing 5 mL of solution.

8. IDENTIFICATION OF ALPHAGAN
® PURITE®
ALPHAGAN® Purite® is a clear green-yellow solution, essentially free of any visible particulate matter.

9. REGISTRATION NUMBER
A39/15.4/0202

10. NAME AND ADDRESS OF REGISTRATION HOLDER
Allergan Pharmaceuticals (Pty) Ltd
30 New Road (entrance off Bavaria Road)
Randjespark Ext. 11, Midrand, 1682
Johannesburg, Gauteng
South Africa
Telephone number: (011) 545 6600

11. DATE OF PUBLICATION
Date of registration: 5 October 2007
Date of revision of the patient information leaflet: 02 October 2015

Updated on this site: October 2015
PIL New addition to this site: October 2015
Source: Pharmaceutical Industry

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