Consumer medicine information

Eyezep Eye Drops

Azelastine hydrochloride

BRAND INFORMATION

Brand name

Eyezep

Active ingredient

Azelastine hydrochloride

Schedule

S2

 

Consumer medicine information (CMI) leaflet

Please read this leaflet carefully before you start using Eyezep Eye Drops.

FULL CMI

EYEZEP®

Active ingredient(s): azelastine hydrochloride (azel-as-teen hydro-klor-ide) eye drops


Consumer Medicine Information (CMI)

This leaflet provides important information about using EYEZEP. You should also speak to your doctor or pharmacist if you would like further information or if you have any concerns or questions about using EYEZEP.

Where to find information in this leaflet:

1. Why am I using EYEZEP?
2. What should I know before I use EYEZEP?
3. What if I am taking other medicines?
4. How do I use EYEZEP?
5. What should I know while using EYEZEP?
6. Are there any side effects?
7. Product details

1. Why am I using EYEZEP?

EYEZEP contains the active ingredient azelastine hydrochloride. EYEZEP belongs to a group of medicines called antihistamines. It works by blocking the action of histamine and other substances produced by the body, which are causing your allergies.

EYEZEP is used for the treatment and prevention of seasonal and non-seasonal (perennial) allergic conjunctivitis, caused by allergies, such as to pollen (hay fever) or house dust mites. The effects are red, itchy and/or watery eyes, sometimes together with sneezing or a runny, itchy or blocked nose.

EYEZEP is not addictive.

2. What should I know before I use EYEZEP?

Warnings

Do not use EYEZEP if you have an allergy to EYEZEP or any of the ingredients listed at the end of this leaflet.

Always check the ingredients to make sure you can use this medicine.

Do not give EYEZEP to a child under 4 years, unless directed by the child's doctor.

The safety and effectiveness of EYEZEP in children under 4 years have not been established.

Do not use EYEZEP after the expiry date printed on the pack.

Do not use EYEZEP after 4 weeks of first opening the bottle.

Do not use EYEZEP if the packaging is torn or shows signs of tampering.

Check with your doctor or pharmacist if you:

  • have kidney disease
  • take any medicines for any other condition
  • have allergies to any other substances, such as foods, preservatives or dyes.
  • Are wearing contact lenses.

During treatment, you may be at risk of developing certain side effects. It is important you understand these risks and how to monitor for them. See additional information under Section 6. Are there any side effects?

Pregnancy and breastfeeding

Check with your doctor or pharmacist if you are pregnant or intend to become pregnant.

Talk to your doctor or pharmacist if you are breastfeeding or intend to breastfeed.

3. What if I am taking other medicines?

Tell your doctor or pharmacist if you are taking any other medicines, including any medicines, vitamins or supplements that you buy without a prescription from your pharmacy, supermarket or health food shop.

Some medicines and EYEZEP may interfere with each other if significant amounts of the eye drop is absorbed systematically. These include:

  • Cimetidine, a medicine used to treat stomach ulcers and some other stomach conditions.

Check with your doctor or pharmacist if you are not sure about what medicines, vitamins or supplements you are taking and if these affect EYEZEP.

4. How do I use EYEZEP?

How much to use

  • Use one drop of EYEZEP in each eye every 12 hours as required. This may be increased to one drop in each eye four times daily if required.
  • Follow the instructions provided with the medicine.
  • Do not exceed the recommended dosage.

How to use EYEZEP

Wash your hands before using EYEZEP. Gently wipe around your eyes with a tissue to remove any moisture.

  1. Remove the protective cap.
  2. Unscrew the top of the bottle and check that the dropper is clean.
  3. Gently pull your lower eyelid down.

  1. Carefully place one drop inside the middle of your lower eyelid. Take care not to let the dropper touch your eye.

  1. Release your lower eyelid and gently press on the inner corner of your eye against the bridge of your nose. Then keeping your finger pressed against your nose, slowly blink your eye a few times to spread the drop across the surface. Blot away any excess medication.

  1. Repeat this procedure for your other eye.

If you use too much EYEZEP

If you think that you have used too much EYEZEP, you may need urgent medical attention.

You should immediately:

  • phone the Poisons Information Centre
    (Australia telephone 13 11 26) for advice, or
  • contact your doctor, or
  • go to the Emergency Department at your nearest hospital.

You should do this even if there are no signs of discomfort or poisoning.

5. What should I know while using EYEZEP?

Things you should do

Remind any doctor, dentist or pharmacist you visit that you are using EYEZEP.

If you become pregnant while using EYEZEP, tell your doctor.

A new bottle of EYEZEP is required if used beyond 4 weeks.

The maximum duration of treatment is 6 weeks at a time. Consult your doctor if your symptoms have not cleared up after 6 weeks.

EYEZEP should be used only when necessary.

Things you should not do

  • Do not use a double dose to make up for the dose that you missed.
  • Do not give EYEZEP to anyone else, even if they have the same condition as you.
  • Do not use EYEZEP to treat any other complaints unless your doctor or pharmacist tells you to. EYEZEP is not intended for the treatment of eye infections.

Driving or using machines

Be careful before you drive or use any machines or tools until you know how EYEZEP affects you.

EYEZEP is unlikely to make you feel drowsy. However, if you are drowsy, do not drive a car or operate machinery.

Drinking alcohol

Tell your doctor or pharmacist if you drink alcohol.

If you drink alcohol, any drowsiness may be worse.

Looking after your medicine

  • Keep your EYEZEP in a cool dry place where the temperature stays below 30°C.
  • Do not put EYEZEP in the fridge.

Follow the instructions in the carton on how to take care of your medicine properly.

Store it in a cool dry place away from moisture, heat or sunlight; for example, do not store it:

  • in the bathroom or near a sink, or
  • in the car or on window sills.

Keep it where young children cannot reach it.

When to discard your medicine

Do not use EYEZEP for longer than 4 weeks after the bottle is first opened.

Getting rid of any unwanted medicine

If you no longer need to use this medicine or it is out of date, take it to any pharmacy for safe disposal.

Do not use this medicine after the expiry date.

6. Are there any side effects?

All medicines can have side effects. If you do experience any side effects, most of them are minor and temporary. However, some side effects may need medical attention.

See the information below and, if you need to, ask your doctor or pharmacist if you have any further questions.

Less serious/common side effects

Less serious side effectsWhat to do
  • Irritation in the eyes
  • Stinging or burning in eyes
  • Bitter taste in mouth
Speak to your doctor or pharmacist if you have any of these less serious side effects and they worry you.
Drinking a flavoured drink a few minutes after using EYEZEP may help any bitter taste to go away.

Tell your doctor or pharmacist if you notice anything else that may be making you feel unwell.

Other side effects not listed here may occur in some people.

Reporting side effects

After you have received medical advice for any side effects you experience, you can report side effects to the Therapeutic Goods Administration online at www.tga.gov.au/reporting-problems. By reporting side effects, you can help provide more information on the safety of this medicine.

7. Product details

This medicine is available over-the-counter without a doctor's prescription.

What EYEZEP contains

Active ingredient
(main ingredient)
Azelastine (as hydrochloride) 0.0457% w/v.
Each drop contains 14 µg azelastine (as hydrochloride).
Other ingredients
(inactive ingredients)
  • Hypromellose
  • Disodium edetate
  • Benzalkonium chloride
  • Sorbitol solution 70% (crystallising)
  • Sodium hydroxide
  • Water for injections
Potential allergensN/A

Do not take this medicine if you are allergic to any of these ingredients.

What EYEZEP looks like

EYEZEP (AUST R 97489) is a clear, colourless, water based solution, which comes in a polyethylene bottle with dropper attachment. The bottle contains 6 mL of solution which is equivalent to approximately 180 eye drops.

Who distributes EYEZEP

Viatris Pty Ltd
Level 1, 30 The Bond
30-34 Hickson Road
Millers Point, NSW 2000
www.viatris.com.au
Phone: 1800 274 276

This leaflet was prepared in Oct 2021.

EYEZEP® is a Viatris company trade mark

Eyezep_cmi\Oct21/00

Published by MIMS January 2022

BRAND INFORMATION

Brand name

Eyezep

Active ingredient

Azelastine hydrochloride

Schedule

S2

 

1 Name of Medicine

Azelastine hydrochloride.

2 Qualitative and Quantitative Composition

Eyezep eye drops contain 0.5 mg/mL azelastine hydrochloride as the active ingredient (equivalent to 0.457 mg/mL azelastine base). Eyezep eye drops also contains 0.125 mg/mL of benzalkonium chloride and 0.5 mg/mL of disodium edetate as antimicrobial preservatives.
For the full list of excipients, see Section 6.1 List of Excipients.

3 Pharmaceutical Form

Eyezep (azelastine hydrochloride) eye drops is a clear, colourless, isotonic aqueous solution with a pH of 5.5-6.5.

4 Clinical Particulars

4.1 Therapeutic Indications

Treatment and prevention of the symptoms of seasonal and non-seasonal (perennial) allergic conjunctivitis in adults and children 4 years and older.

4.2 Dose and Method of Administration

Seasonal allergic conjunctivitis.

The usual dosage in adults and children 4 years and older is one drop in each eye twice daily that can be increased, if necessary to four times daily. If allergen exposure is anticipated Eyezep eye drops should be administered prophylactically, prior to exposure.

Non-seasonal (perennial) allergic conjunctivitis.

The usual dosage in adults and children 4 years and older is one drop in each eye twice daily that can be increased, if necessary to four times daily. As safety and efficacy have been demonstrated in clinical trials for a period of up to 6 weeks, the duration of any course should be limited to a maximum of 6 weeks.

4.3 Contraindications

Hypersensitivity to any of the ingredients.

4.4 Special Warnings and Precautions for Use

The preservative in Eyezep eye drops, benzalkonium chloride, may cause eye irritation and discolour soft contact lenses. Where appropriate, contact lenses should be removed before application of the eye drops and not replaced for at least 15 minutes following application.
Eyezep eye drops are not intended for treatment of eye infections.

Use in renal and hepatic impairment.

In a single oral dose study in 9 patients, renal insufficiency (creatinine clearance < 50 mL/min) resulted in a 70-75% higher Cmax and AUC compared to normal subjects. However, the number of patients evaluated in this study is too small to draw meaningful conclusions.
No information regarding the use of Eyezep eye drops in renally impaired patients is available.

Use in the elderly.

A pharmacokinetic study in elderly patients (n=15) receiving oral azelastine hydrochloride 4.4 mg twice daily found a prolongation of the tmax and an increase in Cmax, and AUC compared to results in healthy volunteers. This can be attributed to the age-related changes in physiological functions. There have been no specific studies in the elderly with the eye drops.
While these should be respected for orally administered azelastine, similar considerations are not deemed necessary for the eye drops due to the very low total levels of systemic absorption following this route of administration.

Paediatric use.

The use of Eyezep eye drops can be recommended in children 4 years and older suffering from seasonal or non-seasonal (perennial) allergic conjunctivitis.
The efficacy and safety of Eyezep eye drops in children under 4 years of age has not been established.

Effects on laboratory tests.

No data available.

4.5 Interactions with Other Medicines and Other Forms of Interactions

No specific interactions have been studied with Eyezep eye drops. Interaction studies at high oral doses of azelastine hydrochloride have been performed, however, they bear no relevance to the eye drop formulation as systemic levels would be in the picogram range.
After oral administration of 4.4 mg azelastine hydrochloride twice daily, cimetidine has been shown to increase the plasma levels of azelastine. This is thought to be due to cimetidine inhibiting the metabolism of azelastine by interacting with the hepatic cytochrome P450 system. No interaction was seen following co-medication with ranitidine.
No significant pharmacokinetic interaction was observed with the co-administration of an oral 4.4 mg dose of azelastine hydrochloride twice daily and theophylline 300 mg or 400 mg twice daily.
Interaction studies investigating the cardiac repolarisation effects of concomitantly administered oral azelastine hydrochloride (4.4 mg bd) and erythromycin (500 mg tid) or ketoconazole (200 mg bd) were conducted. Oral erythromycin had no effect on azelastine pharmacokinetics or QTc based on analysis of serial electrocardiograms. Ketoconazole interfered with the measurement of azelastine plasma levels; however, no effects on QTc were observed.

4.6 Fertility, Pregnancy and Lactation

Effects on fertility.

Azelastine demonstrated no carcinogenic potential in mice and rats at dietary doses up to 25 and 30 mg/kg/day, respectively. Azelastine demonstrated no genotoxic potential in standard assays for gene mutations, chromosomal damage and DNA damage. In male and female rats, azelastine at oral doses of 30 mg/kg/day and greater (over 3 orders of magnitude higher than the maximum recommended clinical dose on body surface area basis) caused a decrease in the fertility index, but in long-term toxicity studies up to two years there were no drug related alterations in reproductive organs either in males or in females in this species. A clinical study in 21 healthy human females using an intranasal dose of 1.12 mg/day azelastine found no effect on ovulation or sexual hormone pattern.
(Category B3)
In pregnant rats there was evidence of significant diaplacental transfer of the drug to the foetuses. Azelastine was embryolethal and teratogenic in mice at oral doses greater than 30 mg/kg/day. In rats, azelastine was embryotoxic at oral doses greater than 3 mg/kg/day, and teratogenicity and embryolethality were seen at doses greater than 30 mg/kg/day. In rabbits, azelastine was teratogenic at oral doses greater than 20 mg/kg/day. In pregnant rats, azelastine demonstrated no perinatal/postnatal toxicity at oral doses up to 30 mg/kg/day.
In rats, the no effect doses resulted in plasma levels which were at least 50 times the plasma levels at the maximum recommended ocular dose in humans. (The calculation of the safety factor is based on plasma levels derived from oral subchronic toxicity studies.)
There are no adequate and well-controlled clinical studies in pregnant women. Eyezep eye drops should be used during pregnancy only if the benefit to the mother justifies the potential risk to the foetus.
Australian categorisation definition of Category B3: Drugs which have been taken by only a limited number of pregnant women and women of childbearing age, without an increase in the frequency of malformation or other direct or indirect harmful effects on the human foetus having been observed. Studies in animals have shown evidence of an increased occurrence of foetal damage, the significance of which is considered uncertain in humans.
In lactating rats approximately 0.2% of a 10 mg/kg oral dose of 14C-azelastine was transferred to the maternal milk. A perinatal/postnatal study in rats showed no adverse effect at oral doses up to 30 mg/kg/day. No data are available in humans. Azelastine should not be used in breastfeeding women unless the expected benefits outweigh the risks to the feeding infant.

4.7 Effects on Ability to Drive and Use Machines

Due to the low systemic exposure, no influence is expected. Patients with seasonal allergic conjunctivitis are likely to experience watery and itchy eyes which may affect vision. The mild, transient irritation that may be experienced after application of Eyezep eye drops is unlikely to affect vision to any greater extent. However, if there are any transient effects on vision, the patient should be advised to wait until this clears before driving or operating machinery.

4.8 Adverse Effects (Undesirable Effects)

Eyezep eye drops are generally well tolerated. In the following the most frequent adverse drug reactions with the recommended dosage reported in clinical trials and from post marketing reporting are presented.
Commonly (1.0-10%), a mild, transient irritation (burning or stinging) in the eye on instillation of Eyezep eye drops is experienced. Less frequently reported is a bitter taste. In very rare cases allergic reactions may occur.
Frequency of adverse reactions experienced (see Table 1):

Clinical trial data.

Table 2 shows adverse events/adverse drug reactions reported in clinical trials with Eyezep eye drops with an incidence of > 0.5%, irrespective of a causal relationship to the administration of the drug. A total of 739 patients were exposed to Eyezep eye drops and 606 patients were exposed to placebo.

Reporting suspected adverse effects.

Reporting suspected adverse reactions after registration of the medicinal product is important. It allows continued monitoring of the benefit-risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions at www.tga.gov.au/reporting-problems.

4.9 Overdose

No specific reactions after ocular overdosage are known, and with the ocular route of administration, overdosage reactions are not anticipated.
In the event of overdosage after accidental oral uptake the signs and symptoms which may be anticipated in humans include drowsiness, confusion, coma, tachycardia and hypotension. Symptomatic and supportive treatment should be instigated as there is no known antidote.
For information on the management of overdose, contact the Poison Information Centre on 13 11 26 (Australia).

5 Pharmacological Properties

5.1 Pharmacodynamic Properties

Mechanism of action.

Azelastine hydrochloride, a phthalazinone derivative, is a potent antiallergic compound with histamine H1-receptor antagonist activity and a rapid onset (within 10 to 20 minutes) and long duration (up to 12 hours) of action (for details, see Section 5.1 Pharmacodynamic Properties, Clinical trials). The major metabolite, desmethylazelastine, also exhibits H1-receptor antagonist activity.
Eyezep eye drops are administered as a racemic mixture. The racemate, R- and S-enantiomers were equally potent at inhibiting eyelid histamine-induced oedema in rats, however, the R-enantiomer was 2-fold less active at inhibiting eyeball histamine-induced oedema. In several ocular allergy models azelastine hydrochloride in physiological saline or as an eye drop formulation proved to be effective.
Data from in vivo (preclinical) and in vitro studies show that azelastine inhibits the synthesis or release of the chemical mediators known to be involved in early and late stage allergic reactions, e.g. histamine and leukotriene.
In early phase studies in humans, Eyezep eye drops were effective in the symptomatic relief and the prophylaxis of allergen-induced eye symptoms. These studies use an allergen challenge model. In one study where Eyezep eye drops were administered 20 minutes after conjunctival provocation in 20 asymptomatic patients, relief of symptoms (itching of the eyes, conjunctival redness, lacrimation and swollen eyelid) occurred 10 to 20 minutes following instillation of Eyezep eye drops. The symptoms were assessed according to a 4-point rating scale, with a total symptom score range of 0 to 12. The mean of the total symptom score of all patients of these conjunctival symptoms measured 30 minutes after allergen challenge decreased from 8.5 to 4.6 and from 8.5 to 7.7 following Eyezep eye drops and placebo, respectively. This symptomatic relief of allergen-induced conjunctival symptoms was significantly (p < 0.01) greater than placebo.
A single dose of Eyezep eye drops instilled 6 to 9 hours prior to allergen challenge statistically significantly (p < 0.50) reduced the development of itchy eyes when compared to placebo in 21 asymptomatic patients. In another conjunctival provocation test study involving a total of 32 asymptomatic patients, Eyezep eye drops protected against allergen-induced conjunctival symptoms (itching of the eyes, conjunctival redness) over a period of up to 12 hours (p < 0.01).
Eyezep eye drops also have an effect on the inflammatory process of allergy as defined by a significant decrease in the eosinophilic and neutrophilic infiltration, and ICAM-1 expression during both early and late phase reactions following allergen challenge. Following repeated application of Eyezep eye drops for a period of 7 days, the sum score of conjunctival symptoms (itching of the eyes, conjunctival redness, lacrimation, swollen eyelids) measured 30 minutes after allergen challenge was significantly (p < 0.01) lower following azelastine (2.9) pre-treatment compared to placebo (8.3). Furthermore, the increase of inflammatory cells (monocytes, lymphocytes, eosinophils, neutrophils) in conjunctival scrapings was clearly suppressed by azelastine during the early (30 minutes after challenge) as well as the late (6 hours after challenge) allergic reaction.

Clinical trials.

In a number of placebo- and active-controlled clinical studies, Eyezep eye drops have been shown to be effective in the treatment and prevention of seasonal and non-seasonal (perennial) allergic conjunctivitis, especially for itching of the eye, conjunctival redness, and flow of tears.

Seasonal allergic conjunctivitis.

Five randomised, double-blind, placebo-controlled, confirmatory environmental studies (Study nos. 2981, 2982, 2983, 2984, 2985) were conducted in adult patients. Treatment duration was generally 2 weeks except for one study with a treatment period of 8 weeks (2983). In 4 of the 5 trials, consistent statistically significant superiority favouring the use of Eyezep eye drops over placebo was observed. The design of the remaining trial (2984) was shown to be insensitive, as there was no difference between active treatments and placebo (see Table 3).
Three of these studies (2981, 2984, 2982) additionally compared Eyezep eye drops to either levocabastine (LEV) or disodium cromoglycate (DSCG) eye drops and found the effects of both active substances to be comparable. Long-term safety and efficacy was confirmed in the 8-week study.
Three randomised, double-blind, placebo-controlled environmental studies (3021, 3034, 3062) were performed in children aged 4 to 12 years. Results of these 3 paediatric studies with treatment duration of 2 to 4 weeks were also significantly superior in favour of Eyezep eye drops and confirm the evidence of efficacy seen in the adult studies. All of these trials additionally compared Eyezep eye drops to disodium cromoglycate (DSCG) or levocabastine (LEV) and found the effects of both active substances to be at least comparable.
Primary efficacy endpoint in all of these studies was the responder rate on Day 3. Response was defined as a reduction of ≥ 3 score points in the sum of scores of itching eyes, conjunctival redness, flow of tears within 3 days of start of treatment. The responder rates were statistically significantly superior for Eyezep eye drops compared to placebo in 7 of the 8 studies (p < 0.04) (see Table 4).
The administered dosage of Eyezep eye drops was one drop/eye BID (total daily dose 0.06 mg) and could be increased to one drop/eye TID to QID (at maximum 0.12 mg/day). In all of these studies, the use of Eyezep eye drops was shown to be safe and well tolerated.

Non-seasonal (perennial) allergic conjunctivitis.

Two randomised, double-blind, placebo-controlled environmental trials (3111, 3130) of similar design showed significantly superior effects of Eyezep eye drops compared to placebo in adults ≥ 18 years over a treatment duration of 6 weeks. The predominant therapeutic effect in both studies was seen on itching of the eyes and conjunctival redness and was most pronounced by the end of the treatment period. One of the trials (3111) additionally compared Eyezep eye drops to levocabastine (LEV) and found the effects of both active substances to be comparable (see Table 5).
In non-seasonal (perennial) allergic conjunctivitis Eyezep eye drops were administered as one drop/eye BID (total daily dose 0.06 mg). The dosage could be increased to one drop/eye TID to QID (at maximum 0.12 mg/day). Both studies found the use of Eyezep eye drops to be safe and well tolerated.

Other information.

No irritant or sensitising properties of single or repeated applications of Eyezep eye drops on eye structures were found in studies involving healthy subjects. After topical application of Eyezep eye drops to healthy subjects and patients with allergic conjunctivitis symptoms, respectively, there was no effect on the intraocular pressure, on the corneal re-epithelialisation process, or on tear formation.
No local anaesthetic effect was detected in man by means of a Cochet-Bonnet-Aesthesiometer measuring corneal sensitivity at different time points following single and multiple intraocular administration of Eyezep eye drops.

5.2 Pharmacokinetic Properties

Following oral administration, azelastine is rapidly absorbed showing an absolute bioavailability of 81% and is distributed predominantly into the periphery. Plasma elimination half-life of azelastine is approximately 20 hours and about 45 hours for the therapeutically active metabolite desmethylazelastine. Excretion occurs mainly via the faeces.
After repeated ocular application of azelastine eye drops (up to one drop in each eye four times daily), Cmax steady-state plasma levels of azelastine hydrochloride were very low. Systemic absorption of azelastine following long term administration of eye drops lead to extremely low plasma concentrations of azelastine only and, therefore, adverse events related to systemic plasma levels of the compound are unlikely to occur.

5.3 Preclinical Safety Data

Genotoxicity.

See Section 4.6 Fertility, Pregnancy and Lactation.

Carcinogenicity.

See Section 4.6 Fertility, Pregnancy and Lactation.

6 Pharmaceutical Particulars

6.1 List of Excipients

Hypromellose, disodium edetate, benzalkonium chloride, sorbitol solution 70% (crystallising), sodium hydroxide, water for injections.

6.2 Incompatibilities

See Section 4.4 Special Warnings and Precautions for Use; Section 4.5 Interactions with Other Medicines and Other Forms of Interactions.

6.3 Shelf Life

In Australia, information on the shelf life can be found on the public summary of the Australian Register of Therapeutic Goods (ARTG).
The expiry date can be found on the packaging.

6.4 Special Precautions for Storage

Store below 30°C.
Eyezep eye drops should be discarded 4 weeks after first opening.

6.5 Nature and Contents of Container

Eyezep eye drops (AUST R 97489) is available in a 6 mL or 10 mL* screw cap HDPE bottle with dropper.
*Not marketed.

6.6 Special Precautions for Disposal

In Australia, any unused medicine or waste material should be disposed of by taking it to your local pharmacy.

6.7 Physicochemical Properties

Azelastine hydrochloride is chemically (RS)-4-(4-chlorobenzyl)-2-(1-methylazepan-4-yl) phthalazin-1 (2H)-one hydrochloride.

Chemical structure.


CAS number.

79307-93-0.
The chemical formula is C22H24OClN3.HCI and its molecular weight is 418.37. It is presented as the racemate.
Azelastine hydrochloride is a white to light beige crystalline, odourless powder. It is freely soluble in chloroform, soluble in ethanol and sparingly soluble in water. It is practically insoluble in ether, n-hexane and toluene.

7 Medicine Schedule (Poisons Standard)

S2 (Pharmacy Medicine).

Summary Table of Changes