OptiPranolol Side Effects

Please note - some side effects for OptiPranolol may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA at http://www.fda.gov/medwatch/ or 1-800-FDA-1088 (1-800-332-1088).

Side Effects of OptiPranolol - for the Consumer

OptiPranolol Drops

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome when using OptiPranolol Drops:

Blurred vision; brow ache; increased tearing; sensitivity to light.

Severe allergic reactions (rash; hives; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); changes in heart rate; chest pain; eye or eyelid swelling; headache; muscle weakness; shortness of breath; slow or irregular heartbeat; vision changes.

OptiPranolol Side Effects - for the Professional

OptiPranolol

In clinical trials, the use of OptiPranolol Ophthalmic Solution has been associated with transient local discomfort.

Other ocular adverse reactions, such as abnormal vision, blepharitis, blurred vision, browache, conjunctivitis, edema, eyelid dermatitis, photophobia, tearing, and uveitis have been reported in small numbers of patients.

Other systemic adverse reactions, such as allergic reaction, angina, anxiety, arthritis, asthenia, atrial fibrillation, bradycardia, bronchitis, coughing, depression, dizziness, dyspnea, epistaxis, headache, hypertension, myalgia, myocardial infarct, nausea, nervousness, palpitation, rash, rhinitis, and somnolence have also been reported in small numbers of patients.

Side Effects by Body System

Ocular

Ocular side effects have included a stinging and burning sensation upon instillation of the drug in 30% to 80% of patients. Hyperemia of the eyelid and conjunctiva, slight reductions in tear production, pruritus, photophobia, or foreign body sensation are reported in up to 25% of patients. Abnormal vision, blepharitis, blurred vision, browache, conjunctivitis, edema, eyelid dermatitis, tearing, and uveitis have been reported rarely. Ocular inflammation with secondary elevation of intraocular pressure has also been reported.

Metipranolol may induce at least three types of ocular inflammation: granulomatous anterior uveitis, combined granulomatous anterior uveitis, and blepharoconjunctivitis. In one study of 247 patients, 50 eyes from 28 patients showed over 70 episodes of ocular inflammation. These types of inflammation are associated with increased intraocular pressure (IOP) in 12% to 15% of normal eyes. The incidence of increased IOP in patients with metipranolol-induced ocular inflammation was approximately 60%. Of 45 cases of ocular inflammation with elevated IOP, 42 (93%) were attributed to metipranolol 0.6%, and 3 (7%) were attributed to metipranolol 0.3% solution. This increased risk of increased IOP suggests that metipranolol may cause secondary elevation of IOP. The mechanism is not known, but may involve drug-induced changes in the trabecular meshwork. Because of this, the drug has been withdrawn from the market in England by the manufacturer.

Metipranolol has caused histamine release in human leukocytes, which may account for its irritant effects.

In most patients stinging and burning upon instillation of the drug is transient and of insufficient severity to warrant discontinuation of the drug.

Cardiovascular

Cardiovascular side effects have rarely included changes in heart rate and blood pressure, angina, atrial fibrillation, bradycardia, hypertension, palpitation, and myocardial infarct.

Cardiovascular side effects associated with other ophthalmic beta blockers have included heart failure.

In one study of 2,483 patients with glaucoma, the use of ocular metipranolol 0.3% and 0.6% for 12 months was not associated with clinically relevant changes in heart rate or blood pressure. Of note, however, patients with preexisting bradycardia or conduction abnormalities were excluded from study participation.

Reports of changes in heart rate and blood pressure are usually observed 45 minutes after drug administration, and are usually clinically insignificant. Heart rate reductions of 1 to 4 bpm or systolic blood pressure reductions of 11 mmHg may be observed.

Respiratory

Respiratory side effects have rarely included bronchitis, coughing, dyspnea, rhinitis, and acute pulmonary edema.

Respiratory side effects associated with other beta blockers and/or metipranolol have included bronchospasm.

Patients with a reactive component to their lung disease, such as bronchial asthma, receiving metipranolol ophthalmic therapy should be closely monitored for bronchospasm.

In one study of 10 asthmatic patients (studied between asthmatic episodes and without respiratory infection), an average decrease of 15.1% in the forced expiratory volume in one second (FEV1) was observed after the administration of metipranolol, reaching a nadir at 45 minutes after drug administration. No change in vital capacity was observed.

In one study of 47 patients with open or narrow angle glaucoma, one developed respiratory difficulties. Because patients with preexisting reactive airways disease were excluded from study participation, this incidence may be underestimated.

A 72-year-old woman with no history of pulmonary or cardiac disease developed signs and symptoms consistent with acute cardiogenic pulmonary edema within 1 hour after using metipranolol eyedrops. Inadvertent rechallenge was positive.

Nervous system

Headache or fatigue rarely necessitate therapy withdrawal.

Nervous system side effects have included headache and fatigue in up to 5% of patients. Anxiety, dizziness, nervousness, and somnolence have been reported rarely.

Local

Local side effects have rarely included periorbital dermatitis and marginal keratitis.

Hypersensitivity

A 52-year-old woman with glaucoma developed bilateral periorbital dermatitis associated with the use of metipranolol 0.6% eye drops. Skin patch testing revealed 2+ sensitivity to racemic metipranolol base and to penbutolol sulfate. Controls were negative.

Hypersensitivity side effects have rarely included allergic reactions.

Psychiatric

Psychiatric side effects have rarely included depression.

Musculoskeletal

Musculoskeletal side effects have rarely included arthritis, asthenia, and myalgia.

Other

Other side effects have rarely included epistaxis.

Gastrointestinal

Gastrointestinal side effects have rarely included nausea.

Dermatologic

Dermatologic side effects have rarely included rash.

Endocrine

Endocrine side effects associated with ophthalmic beta blockers have included masking of both the signs and symptoms of hypoglycemia in insulin-dependent diabetics, and hyperthyroidism/thyroid storm.

General

Metipranolol is generally well-tolerated. Side effects are usually mild and transient. Systemic side effects are unusual because of the low systemic absorption of ophthalmic metipranolol; however, side effects similar to other systemically administered beta-blockers may be experienced.

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