Betoptic S

This medication is used alone or with other medications to treat high pressure inside the eye due to glaucoma (open-angle type) or other eye diseases (e.g., ocular hypertension). Lowering high pressure inside the eye helps to prevent blindness. Betaxolol belongs to a class of drugs known as beta blockers and works by decreasing the amount of fluid that is made within the eye.

Temporary stinging/discomfort of the eye, watery/dry/itchy/red eyes, blurred vision, feeling as if something is in the eye, crusting of eyelashes, headache, trouble sleeping, or dizziness may occur. If any of these effects persist or worsen, notify your doctor or pharmacist promptly.Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.Tell your doctor immediately if any of these unlikely but serious side effects occur: eye pain/swelling/discharge, vision changes, increased eye sensitivity to light, swelling of the ankles/feet, tiredness, slow/irregular heartbeat, muscle weakness, mental/mood changes, hair loss.Seek immediate medical attention if any of these rare but very serious side effects occur: trouble breathing, sudden unexplained weight gain, chest pain, weakness on one side of the body, slurred speech, confusion, persistent dizziness, fainting.A very serious allergic reaction to this drug is rare. However, seek immediate medical attention if you notice any of the following symptoms of a serious allergic reaction: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.In the US -Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Follow all directions on your prescription label. Do not use this medicine in larger or smaller amounts or for longer than recommended.

The usual dose of this medicine is 1 drop into the affected eye 2 times per day. Follow your doctor's dosing instructions very carefully.

Shake the eyedrops well just before using them.

Do not use this medicine while wearing contact lenses. Betaxolol ophthalmic may contain a preservative that can discolor soft contact lenses. Wait at least 15 minutes after using this medicine before putting in your contact lenses.

Wash your hands before using the eye drops.

To apply the eye drops:

• Tilt your head back slightly and pull down your lower eyelid to create a small pocket. Hold the dropper above the eye with the tip down. Look up and away from the dropper and squeeze out a drop.

• Close your eyes for 2 or 3 minutes with your head tipped down, without blinking or squinting. Gently press your finger to the inside corner of the eye for about 1 minute, to keep the liquid from draining into your tear duct.

• Use only the number of drops your doctor has prescribed. If you use more than one drop, wait about 5 minutes between drops.

• Wait at least 10 minutes before using any other eye drops your doctor has prescribed.

Do not touch the tip of the eye dropper or place it directly on your eye. A contaminated dropper can infect your eye, which could lead to serious vision problems.

Do not use the eye drops if the liquid has changed colors or has particles in it. Call your pharmacist for new medicine.

Tell your doctor right away if you have any eye injury or eye infection.

If you need surgery, including eye surgery, tell the surgeon ahead of time that you are using betaxolol ophthalmic. You may need to stop using the medicine for a short time.

Store in an upright position at room temperature, away from moisture and heat. Do not freeze. Keep the bottle tightly closed when not in use.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222 if anyone has accidentally swallowed the medication.

An overdose of betaxolol ophthalmic is not expected to produce symptoms unless the medicine is absorbed into your bloodstream. Overdose symptoms may include slow heartbeats, feeling light-headed, trouble breathing, and chest pain or tightness.

Your eye doctor will tell you how much of this medicine to use and how often. Do not use more medicine or use it more often than your doctor tells you to. This medicine is not for long-term use.

Shake the medicine well just before each use.

This medicine can be used with other eye drops. Wait at least 10 minutes before using another eye drops. This will help prevent the second medicine from “washing out” the first one. .

If you are wearing contact lenses, remove them before you use the eye drops. Wait for at least 15 minutes before putting the contact lenses back in.

To use the eye drops:

• First, wash your hands. Tilt the head back and, pressing your finger gently on the skin just beneath the lower eyelid, pull the lower eyelid away from the eye to make a space. Drop the medicine into this space. Let go of the eyelid and gently close the eyes. Do not blink. Keep the eyes closed and apply pressure to the inner corner of the eye with your finger for 1 or 2 minutes to allow the medicine to be absorbed by the eye.
• Immediately after using the medicine, wash your hands to remove any medicine that may be on them.
• To keep the medicine as germ-free as possible, do not touch the applicator tip to any surface (including the eye). Also, keep the container tightly closed. Serious damage to the eye and possible loss of vision may result from using contaminated eye drops.

Dosing

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

• For ophthalmic dosage form (eye drops):
  • For glaucoma or ocular hypertension:
    • Adults and children—One drop in the affected eye(s) two times a day.

Missed Dose

If you miss a dose of this medicine, apply it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule.

Storage

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

It is very important that your doctor check your progress at regular visits to make sure this medicine is working properly and to check for unwanted effects.

If itching, redness, swelling, or other signs of eye or eyelid irritation occur, check with your doctor. These signs may mean that you are allergic to this medicine.

Betaxolol may cause heart failure in some patients. Check with your doctor right away if you are having chest pain or discomfort, dilated neck veins, extreme fatigue, irregular breathing, an irregular heartbeat, swelling of the face, fingers, feet, or lower legs, trouble breathing, or weight gain. .

This medicine may cause changes in your blood sugar levels. Also, this medicine may cover up signs of low blood sugar, such as a rapid pulse rate. Check with your doctor if you have these problems or if you notice a change in the results of your blood or urine sugar tests.

Make sure any doctor or dentist who treats you knows that you are using this medicine. You may need to stop using this medicine several days before having surgery.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

Pregnancy

Teratogenic Effects

Reproduction, teratology, and peri- and postnatal studies have been conducted with orally administered betaxolol HCl in rats and rabbits. There was evidence of drug related postimplantation loss in rabbits and rats at dose levels above 12 mg/kg and 128 mg/kg, respectively. Betaxolol HCl was not shown to be teratogenic, however, and there were no other adverse effects on reproduction at subtoxic dose levels. There are no adequate and well-controlled studies in pregnant women.

Betoptic S Ophthalmic Suspension 0.25% should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

Nursing Mothers

It is not known whether betaxolol HCl is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when Betoptic S Ophthalmic Suspension 0.25% is administered to nursing women.

Pediatric Use

Safety and Intraocular Pressure (IOP) lowering effect of Betoptic S Ophthalmic Suspension 0.25% has been demonstrated in pediatric patients in a 3-month, multicenter, double-masked, active-controlled trial.

Geriatric Use

No overall differences in safety or effectiveness have been observed between elderly and younger patients.

Mechanism of Action

Betaxolol HCl, a cardioselective (beta-1-adrenergic) receptor inhibitor, does not have significant membrane-stabilizing (local anesthetic) activity and is devoid of intrinsic sympathomimetic action. Orally administered beta-adrenergic receptor inhibitors reduce cardiac output in healthy subjects and patients with heart disease. In patients with severe impairment of myocardial function, beta-adrenergic receptor antagonists may inhibit the sympathetic stimulatory effect necessary to maintain adequate cardiac function.

When instilled in the eye, Betoptic S Ophthalmic Suspension 0.25% has the action of reducing elevated intraocular pressure, whether or not accompanied by glaucoma. Ophthalmic betaxolol has minimal effect on pulmonary and cardiovascular parameters.

Elevated IOP presents a major risk factor in glaucomatous field loss. The higher the level of IOP, the greater the likelihood of optic nerve damage and visual field loss. Betaxolol has the action of reducing elevated as well as normal intraocular pressure and the mechanism of ocular hypotensive action appears to be a reduction of aqueous production as demonstrated by tonography and aqueous fluorophotometry.

Pharmacodynamics

The onset of action with betaxolol can generally be noted within 30 minutes and the maximum effect can usually be detected 2 hours after topical administration. A single dose provides a 12-hour reduction in intraocular pressure. In some patients, the intraocular pressure lowering responses to BETOPTIC S may require a few weeks to stabilize. As with any new medication, careful monitoring of patients is advised.

Ophthalmic betaxolol solution at 1% (one drop in each eye) was compared to placebo in a crossover study challenging nine patients with reactive airway disease. Betaxolol HCl had no significant effect on pulmonary function as measured by Forced Expiratory Volume in 1 second (FEV1), Forced Vital Capacity (FVC), FEV1/FVC and was not significantly different from placebo. The action of isoproterenol, a beta stimulant, administered at the end of the study was not inhibited by ophthalmic betaxolol.

No evidence of cardiovascular beta adrenergic-blockade during exercise was observed with betaxolol in a double-masked, crossover study in 24 normal subjects comparing ophthalmic betaxolol and placebo for effects on blood pressure and heart rate.

• It is used to treat glaucoma.
• It is used to lower high eye pressure.

WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:

• Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
• Change in eyesight, eye pain, or very bad eye irritation.
• Shortness of breath, a big weight gain, or swelling in the arms or legs.
• Slow heartbeat.
• A heartbeat that does not feel normal.
• Muscle weakness.
• Weakness on 1 side of the body, trouble speaking or thinking, change in balance, drooping on one side of the face, or blurred eyesight.
• Change in color of hands or feet from pale to blue or red.
• Numbness, pain, tingling, or cold feeling of the hands or feet.
• Any sores or wounds on the fingers or toes.

Common side effects of Betoptic S include: eye pain. See below for a comprehensive list of adverse effects.