MIOSTAT™

MIMS Revision Date: 01 March 2021

1 Name of Medicine

Carbachol.

2 Qualitative and Quantitative Composition

Miostat intraocular injection contains carbachol 150 microgram/1.5 mL (0.01%).
For a full list of excipients, see Section 6.1 List of Excipients.

3 Pharmaceutical Form

Solution for injection.
Sterile, balanced salt solution of carbachol for intraocular injection.

4 Clinical Particulars

4.1 Therapeutic Indications

Intraocular use for miosis during surgery.

4.2 Dose and Method of Administration

This is not a multidose container and should not be used for more than one patient. Contains no antimicrobial agent. Use once only and discard any residue.
Aseptically remove the sterile vial from the blister package by peeling the backing paper and dropping the vial onto a sterile tray.
Withdraw the contents into a dry sterile syringe and replace the needle with an atraumatic cannula prior to intraocular irrigation. No more than one-half mL should be gently instilled into the anterior chamber for the production of satisfactory miosis. It may be instilled before or after securing sutures. Miosis is usually maximal within two to five minutes after application.

4.3 Contraindications

Should not be used in those persons showing hypersensitivity to any of the components of this medicine (see Section 6.1 List of Excipients).

4.4 Special Warnings and Precautions for Use

For single dose intraocular use only.
Discard unused portion.
Intraocular carbachol 0.01% should be used with caution in patients with acute cardiac failure, bronchial asthma, peptic ulcer, hyperthyroidism, G.I. spasm, urinary tract obstruction and Parkinson's disease.
The use of intraocular carbachol may increase surgically induced intraocular inflammation.
The vial stopper contains natural rubber (latex) which may cause severe allergic reactions.
Use in the elderly. No data available.
Paediatric use. Safety and efficacy in paediatric patients have not been established.
Effects on laboratory tests. No data available.

4.5 Interactions with Other Medicines and Other Forms of Interactions

No clinically relevant interactions have been described with intraocular carbachol.

4.6 Fertility, Pregnancy and Lactation

Effects on fertility. Studies have not been performed to evaluate the effect of topical ocular administration of carbachol on human fertility.
Use in pregnancy. (Category B2)
There are no adequate and well controlled studies in pregnant women. Animal studies do not indicate direct or indirect harmful effects with respect to reproductive toxicity. As a precautionary measure, it is preferable to avoid the use of intraocular carbachol during pregnancy. Carbachol should be used during pregnancy only if the potential benefit justifies the potential risk to the foetus.
Use in lactation. It is not known if carbachol is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when carbachol is administered to a breastfeeding woman. Therefore, use only when considered essential by the physician.

4.7 Effects on Ability to Drive and Use Machines

Miosis may cause blurred vision and difficulty in dark adaptation. If temporary blurred vision occurs following surgery where intraocular carbachol was used, the patient must wait until vision clears before driving or using machinery.

4.8 Adverse Effects (Undesirable Effects)

Ocular. Corneal clouding, persistent bullous keratopathy and postoperative iritis following cataract extraction with utilisation of intraocular carbachol have been reported with the occasional patient. As with all miotics, retinal detachment has been reported when miotics are used in certain susceptible individuals.
Systemic. Side effects such as flushing, sweating, epigastric distress, abdominal cramps, tightness in urinary bladder and headache have been reported after systemic or topical use of carbachol. These symptoms were not reported following intraocular use of carbachol in premarketing studies.
Postmarketing events. The following adverse reactions are classified according to the following convention: very common (≥ 1/10); common (≥ 1/100 to < 1/10); uncommon (≥ 1/1,000 to < 1/100); rare (≥ 1/10,000 to < 1/1,000); very rare (< 1/10,000); or not known (cannot be estimated from the available data), according to system organ classes. Within each frequency grouping, adverse reactions are presented in order of decreasing seriousness. The adverse reactions have been observed during clinical trials and postmarketing experience with intraocular carbachol:
Nervous system disorders. Uncommon (≥ 0.1% to < 1%): headache.
Eye disorders. Uncommon (≥ 0.1% to < 1%): intraocular pressure increased.
Not known: corneal opacity, anterior chamber inflammation, corneal oedema, eye inflammation, visual impairment, corneal degeneration, drug effect prolonged (miosis), vision blurred, eye pain, ocular hyperaemia.
Gastrointestinal disorders. Not known: vomiting.
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 and in New Zealand, at www.medsafe.govt.nz/Safety/report-a-problem.asp.

4.9 Overdose

In case of overdose, symptoms of toxicity may include: headache, salivation, syncope, bradycardia, hypotension, abdominal cramps, vomiting, asthma and diarrhoea.
Treatment of overdose is supportive. In cases of severe systemic toxicity therapy with anticholinergics may be necessary. Atropine should be administered parenterally (for dosage refer to Goodman and Gilman or other pharmacology reference).
For information on the management of overdose in Australia contact the Poisons Information Centre on 13 11 26; in New Zealand call 0800 POISON or 0800 764 766.

5 Pharmacological Properties

5.1 Pharmacodynamic Properties

Mechanism of action. Carbachol is a potent cholinergic (parasympathomimetic) agent.
Clinical trials. No data available.

5.2 Pharmacokinetic Properties

No data available.

5.3 Preclinical Safety Data

Genotoxicity. No data available.
Carcinogenicity. Studies in animals to evaluate the carcinogenic potential have not been conducted.

6 Pharmaceutical Particulars

6.1 List of Excipients

Sodium chloride 9.6 mg; potassium chloride 1.125 mg; calcium chloride dihydrate 720 microgram; magnesium chloride hexahydrate 450 microgram; sodium acetate 5.85 mg; sodium citrate dihydrate 2.55 mg; sodium hydroxide and/or hydrochloric acid (to adjust pH); water for injections.

6.2 Incompatibilities

Incompatibilities were either assessed or not identified as part of the registration of this medicine.

6.3 Shelf Life

2 years.
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 25°C. Do not freeze.

6.5 Nature and Contents of Container

1.5 mL vials; packed twelve to a carton or as single vials when supplied with Custom-Pak. The vial stopper contains natural rubber (latex).

6.6 Special Precautions for Disposal

In Australia, any unused medicine or waste material should be disposed of in accordance with local requirements.

6.7 Physicochemical Properties

Chemical structure.

CAS number. 51-83-2.
Established name: carbachol.
Chemical name: 2-[(aminocarbonyl) oxy]-N,N,N-trimethylethanaminium chloride.

7 Medicine Schedule (Poisons Standard)

Prescription only medicine (Schedule 4).

Date of First Approval

29 June 1992

Date of Revision

27 January 2021

Summary Table of Changes