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BETAGAN 0,5% Liquifilm Sterile Ophthalmic Solution
BETAGAN 0,5% Liquifilm Sterile Ophthalmic Solution
SCHEDULING STATUS:
Schedule3
PROPRIETARY NAME
(and dosage form):
BETAGAN 0,5% Liquifilm Sterile Ophthalmic Solution
COMPOSITION
BETAGAN 0,5% Liquifilm Sterile Ophthalmic solution contains:
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Levobunolol hydrochloride 5mg/mL |
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Liquifilm (polyvinyl alcohol) 14mg/mL |
Sodium metabisulphite (antioxidant) 2mg/mL
Benzalkonium chloride (preservative) 0,004% m/v.
PHARMACOLOGICAL CLASSIFICATION
A 15.4. Ophthalmic preparations. Other
PHARMACOLOGICAL ACTION
Levobunolol is a non-cardioselective beta-adrenoreceptor blocking agent, equipotent at both beta1, and beta2 receptors. Levobunolol is 60times more potent than its dextro isomer in its beta-blocking activity. In order to obtain the highest degree of beta-blocking potential without increasing the potential for direct myocardial depression, the levo isomer, levobunolol, is used. Levobunolol does not have significant local anaesthetic (membrane stabilising) or intrinsic sympathomimetic activity.
BETAGAN, when instilled in the eye, will lower elevated intraocular pressure as well as normal intraocular pressure, whether or not accompanied by glaucoma.
The onset of action with one drop of BETAGAN can be detected within one hour after treatment, with maximum effect seen between two and six hours. A significant decrease can be maintained for up to 24hours following a single dose.
The exact mechanism of action of levobunolol in reducing intraocular pressure is not known. BETAGAN reduces intraocular pressure with little or no effect on pupil size in contrast to the miosis which cholinergic agents are known to produce.
INDICATIONS
BETAGAN is indicated for the control of intraocular pressure in chronic open angle glaucoma and ocular hypertension.
CONTRA-INDICATIONS
BETAGAN is contraindicated in patients with severe chronic obstructive pulmonary disease, bronchospasm, including bronchial asthma, second and third degree heart block and bradycardia less than 50per minute, peripheral vascular disease and Raynaud’s phenomenon. BETAGAN is also contraindicated in those individuals who are hypersensitive to any constituent of this product.
WARNINGS
In the perioperative period it is generally unwise to reduce the dosage. A patient’s normal tachycardiac response to hypovolaemia or blood loss may be obscured during or after surgery. Particular caution should be taken in this regard.
As the possibility of adverse effects on the corneal permeability and the danger of disruption of the corneal epithelium with prolonged or repeated usage of benzalkonium chloride preserved ophthalmological preparations cannot be excluded, regular ophthalmological examination is required.
Caution should be exercised in the use of benzalkonium chloride preserved topical medication over an extended period in patients with extensive ocular surface disease.
DOSAGE AND DIRECTIONS FOR USE
The usual dose is one drop in the affected eye(s) twice a day.
Patients suffering from renal dysfunction or the elderly may require a reduction in the normal dose.
SIDE EFFECTS AND SPECIAL PRECAUTIONS
Blepharoconjunctivitis and decreases in heart rate and blood pressure have been reported with the use of BETAGAN. Urticaria, change in heart rhythm, headache, dizziness, transient ocular burning, stinging and itching have been reported with the use of BETAGAN. Although reactions of the oculocutaneous syndrome have not been reported with BETAGAN, their development with long-term use cannot be excluded.
Even though BETAGAN is for ophthalmic use, it may be absorbed systemically resulting in a reaction in sensitive patients. The following systemic beta-blocker effects should be borne in mind:
Bronchoconstriction may occur in patients suffering from asthma, bronchitis and other chronic pulmonary diseases. The following may also occur with beta-blocker therapy: congestive cardiac failure, marked bradycardia, vague fatigue, malaise, sleeplessness, vivid dreams, nightmares, overt psychosis, exacerbation of peripheral vascular disease, or the development of Raynaud’s phenomenon (due to unopposed arteriolar (alpha)- sympathetic activation), sexual impotence, hypoglycaemia, skeletal muscle weakness and gastrointestinal disturbances. Severe peripheral vascular disease and even peripheral gangrene may be precipitated.
Adverse reactions to beta-blockers are more common in elderly patients, in patients with renal decompensation, and in patients who receive the drug intravenously.
Congestive heart failure should be adequately controlled before beginning therapy with BETAGAN. In patients with a history of cardiac disease, pulse rates should be monitored. BETAGAN should be used with caution in patients with known diminished pulmonary function and in those with known hypersensitivity to other beta-blocking agents. Particular caution should be exercised in administering beta-blockers to patients suffering from peripheral vascular diseases and from Raynaud’s phenomenon. Abrupt discontinuation of beta-blocker therapy may cause exacerbation of angina pectoris in patients suffering from ischaemic heart disease; therefore, discontinuation of therapy should be gradual and patients should be advised to limit the extent of their physical activity during the period that the medicine is being discontinued.
Beta-blockers should never be given to patients with a phaeochromocytoma without concomitant alpha-adrenergic blocker therapy. Safety during long-term administration has not been demonstrated.
DRUG INTERACTIONS:
BETAGAN may have additive effects in patients taking systemic anti-hypertensive drugs. These possible additive effects may include hypotension, including orthostatic hypotension, bradycardia, dizziness and/or syncope. Conversely, systemic beta-adrenoreceptor blocking agents may potentiate the ocular hypotensive effect of BETAGAN. It can be dangerous to administer beta-blockers concomitantly with the following medicines: digitalis, hypoglycaemic agents, phenothiazines and various anti-arrhythmic agents.
Important: Such drug-drug interactions can have life-threatening consequences.
Special note:
Digitalisation of patients receiving long-term beta-blocker therapy may be necessary if congestive cardiac failure is likely to develop. This combination can be considered despite the potentiation of negative chronotropic effect of the two medicines. Careful control of dosages and of the individual patient response (and notably pulse rate) is essential in this situation.
Pregnancy:
The safety of BETAGAN in pregnancy has not been established. The administration of systemic beta-blockers to pregnant mothers shortly before giving birth, or during labour has resulted in the newborn infants being born hypotonic, collapsed and hypoglycaemic.
Nursing mothers:
It is not known whether BETAGAN is excreted in human milk. Systemic beta-blockers are known to be excreted in human milk. Because similar drugs are excreted in human milk, caution should be exercised when BETAGAN is administered to a nursing woman.
Paediatric use:
Safety and effectiveness in children have not been established.
KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT
No data are available regarding overdosage with BETAGAN in humans. Should accidental ocular overdosage occur, flush eye(s) with water or normal saline.
Overdosage with beta-blockers may produce bradycardia and severe hypotension. Bronchospasm and heart failure may be produced in certain individuals. Bradycardia associated with severe hypotension should be treated with intravenous atropine; if necessary, this should be followed up by a slow intravenous infusion of isoprenaline. Bronchospasm should be treated by intravenous aminophyline, and heart failure with digitalis and diuretics.
IDENTIFICATION
BETAGAN is a colourless to light yellow solution.
PRESENTATION
BETAGAN Liquifilm Sterile Ophthalmic Solution is supplied in sterile dropper bottles containing 5mL or 7,5mL solution.
STORAGE INSTRUCTIONS
Store below 25ºC. Protect from light. Do not use more than 30days after opening. KEEP OUT OF REACH OF CHILDREN.
REGISTRATION NUMBER:
S/15.4/194
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 THIS PACKAGE INSERT
2 February 1987
Updated on this site: July 2008
Source: Pharmaceutical Industry |
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