Drugs Details

Drugs Info of Ocupress
Drugs Details
  • Drugs Type  : Multum
  • Date : 7th Jan 2015 10:03 pm
  • Brand Name : Ocupress
  • Generic Name : carteolol ophthalmic (Pronunciation: kar TEE oh lol off THAL mik)
Descriptions

Carteolol Hydrochloride (carteolol) Ophthalmic Solution USP, 1% is a nonselective beta-adrenoceptor blocking agent for ophthalmic use.

The chemical name for carteolol hydrochloride (carteolol) is (±)-5-[3-[(1,1-dimethylethyl) amino]-2-hydroxypropoxy]-3,4-dihydro-2(1H)-quinolinone monohydrochloride. The structural formula is as follows:

 

Carteolol Hydrochloride Solution  Structural Formula Illustration

Each mL of sterile solution contains Active: carteolol hydrochloride (carteolol) 10 mg (1%). Preservative: benzalkonium chloride 0.05 mg (0.005%). Inactives: sodium chloride, monobasic and dibasic sodium phosphate, sodium hydroxide and/or hydrochloric acid (to adjust pH to 6.0 - 8.0) and purified water.

What are the possible side effects of carteolol ophthalmic (Ocupress)?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Stop using this medication and call your doctor at once if you have any of these serious side effects:

  • severe swelling, itching, burning, redness, pain, or discomfort in or around your eye;
  • drainage, crusting, or oozing of your eyes or eyelids;
  • bronchospasm (wheezing, chest tightness, trouble breathing);
  • slow heart rate, weak pulse, fainting, slow breathing (breathing may...

Read All Potential Side Effects and See Pictures of Carteolol Hydrochloride »

This monograph has been modified to include the generic and brand name in many instances.

Indications

Carteolol Hydrochloride (carteolol) Ophthalmic Solution 1% has been shown to be effective in lowering intraocular pressure and may be used in patients with chronic open-angle glaucoma and intraocular hypertension. It may be used alone or in combination with other intraocular pressure lowering medications.

Dosage Administration

The usual dose is one drop of Carteolol Hydrochloride (carteolol) Ophthalmic Solution 1% in the affected eye(s) twice a day. If the patient's IOP is not at a satisfactory level on this regimen, concomitant therapy with pilocarpine and other miotics, and/or epinephrine or dipivefrin, and/or systemically administered carbonic anhydrase inhibitors, such as acetazolamide, can be instituted.

How Supplied

Carteolol Hydrochloride (carteolol) Ophthalmic Solution USP, 1% is supplied as a sterile ophthalmic solution in plastic dispenser bottles of 5 mL (NDC 61314-238-05), 10 mL (NDC 61314-238-10) and 15 mL (NDC 61314-238-15).

Store at 15° to 25°C (59° to 77°F) (room temperature) and protect from light.

Dist. by: FALCON Pharmaceuticals, Ltd. Fort Worth, Texas 76134, USA. Mfd. by: ALCON LABORATORIES, INC. Fort Worth, Texas 76134, USA. FDA Rev date: 5/22/2001

This monograph has been modified to include the generic and brand name in many instances.

Side Effects

The following adverse reactions have been reported in clinical trials with Carteolol Hydrochloride (carteolol) Ophthalmic Solution.

Ocular

Transient eye irritation, burning, tearing, conjunctival hyperemia and edema occurred in about 1 of 4 patients. Ocular symptoms including blurred and cloudy vision, photophobia, decreased night vision, and ptosis and ocular signs including blepharoconjunctivitis, abnormal corneal staining, and corneal sensitivity occurred occasionally.

Systemic

As is characteristic of nonselective adrenergic blocking agents, Carteolol may cause bradycardia and decreased blood pressure (See WARNINGS). The following systemic events have occasionally been reported with the use of Carteolol Hydrochloride (carteolol) Ophthalmic Solution: cardiac arrhythmia, heart palpitation, dyspnea, asthenia, headache, dizziness, insomnia, sinusitis, and taste perversion. The following additional adverse reactions have been reported with ophthalmic use of beta1 and beta2 (nonselective) adrenergic receptor blocking agents:

Body As a Whole

Headache

Cardiovascular

Arrhythmia, syncope, heart block, cerebral vascular accident, cerebral ischemia, congestive heart failure, palpitation (see WARNINGS).

Digestive

Nausea

Psychiatric

Depression

Skin

Hypersensitivity, including localized and generalized rash

Respiratory

Bronchospasm (predominantly in patients with pre-existing bronchospastic disease), respiratory failure (see WARNINGS)

Endocrine

Masked symptoms of hypoglycemia in insulin-dependent diabetics (see WARNINGS)

Special Senses

Signs and symptoms of keratitis, blepharoptosis, visual disturbances including refractive changes (due to withdrawal of miotic therapy in some cases), diplopia, ptosis. Other reactions associated with the oral use of nonselective adrenergic receptor blocking agents should be considered potential effects with ophthalmic use of these agents.

Read the Carteolol Hydrochloride (carteolol) Side Effects Center for a complete guide to possible side effects

Learn More »

Interactions

Carteolol Hydrochloride (carteolol) Ophthalmic Solution should be used with caution in patients who are receiving a beta-adrenergic blocking agent orally, because of the potential for additive effects on systemic beta-blockade. Close observation of the patient is recommended when a beta-blocker is administered to patients receiving catecholamine-depleting drugs such as reserpine, because of possible additive effects and the production of hypotension and/or marked bradycardia, which may produce vertigo, syncope, or postural hypotension.

This monograph has been modified to include the generic and brand name in many instances.

Warnings

Carteolol has not been detected in plasma following ocular instillation. However, as with other topically applied ophthalmic preparations, Carteolol may be absorbed systemically. The same adverse reactions found with systemic administration of beta-adrenergic blocking agents may occur with topical administration. For example, severe respiratory reactions and cardiac reactions, including death due to bronchospasm in patients with asthma, and rarely death in association with cardiac failure, have been reported with topical application of beta-adrenergic blocking agents (see CONTRAINDICATIONS).

Cardiac Failure

Sympathetic stimulation may be essential for support of the circulation in individuals with diminished myocardial contractility, and its inhibition by beta-adrenergic receptor blockade may precipitate more severe failure.

In Patients Without a History of Cardiac Failure

Continued depression of the myocardium with beta-blocking agents over a period of time can, in some cases, lead to cardiac failure. At the first sign or symptom of cardiac failure, Carteolol Hydrochloride (carteolol) should be discontinued.

Non-Allergic Bronchospasm

In patients with non-allergic bronchospasm or with a history of non-allergic bronchospasm (e.g., chronic bronchitis, emphysema), Carteolol Hydrochloride (carteolol) Ophthalmic Solution should be administered with caution since it may block bronchodilation produced by endogenous and exogenous catecholamine stimulation of beta2 receptors.

Major Surgery

The necessity or desirability of withdrawal of beta-adrenergic blocking agents prior to major surgery is controversial. Beta-adrenergic receptor blockade impairs the ability of the heart to respond to beta-adrenergically mediated reflex stimuli. This may augment the risk of general anesthesia in surgical procedures. Some patients receiving beta-adrenergic receptor blocking agents have been subject to protracted severe hypotension during anesthesia. For these reasons, in patients undergoing elective surgery, gradual withdrawal of beta-adrenergic receptor blocking agents may be appropriate.

If necessary during surgery, the effects of beta-adrenergic blocking agents may be reversed by sufficient doses of such agonists as isoproterenol, dopamine, dobutamine or levarterenol (see OVERDOSE).

Diabetes Mellitus

Beta-adrenergic blocking agents should be administered with caution in patients subject to spontaneous hypoglycemia or to diabetic patients (especially those with labile diabetes) who are receiving insulin or oral hypoglycemic agents. Beta-adrenergic receptor blocking agents may mask the signs and symptoms of acute hypoglycemia.

Thyrotoxicosis

Beta-adrenergic blocking agents may mask certain clinical signs (e.g., tachycardia) of hyperthyroidism. Patients suspected of developing thyrotoxicosis should be managed carefully to avoid abrupt withdrawal of beta-adrenergic blocking agents which might precipitate a thyroid storm.

Precautions

General

Carteolol Hydrochloride (carteolol) Ophthalmic Solution should be used with caution in patients with known hypersensitivity to other beta-adrenoceptor blocking agents. Use with caution in patients with known diminished pulmonary function. In patients with angle-closure glaucoma, the immediate objective of treatment is to reopen the angle. This requires constricting the pupil with a miotic. Carteolol has little or no effect on the pupil. When Carteolol is used to reduce elevated intraocular pressure in angle-closure glaucoma, it should be used with a miotic and not alone.

Risk from Anaphylactic Reaction

While taking beta-blockers, patients with a history of atopy or a history of severe anaphylactic reaction to a variety of allergens may be more reactive to repeated accidental, diagnostic or therapeutic challenge with such allergens. Such patients may be unresponsive to the usual doses of epinephrine used to treat anaphylactic reactions.

Muscle Weakness

Beta-adrenergic blockade has been reported to potentiate muscle weakness consistent with certain myasthenic symptoms (e.g., diplopia, ptosis and generalized weakness).

Carcinogenesis, Mutagenesis, Impairment of Fertility

Carteolol hydrochloride (carteolol) did not produce carcinogenic effects at doses up to 40 mg/kg/day in two-year oral rat and mouse studies. Test of mutagenicity, including the Ames Test, recombinant (rec)-assay, in vivocytogenetics and dominant lethal assay demonstrated no evidence for mutagenic potential. Fertility of male and female rats and male and female mice was unaffected by administration of carteolol hydrochloride (carteolol) dosages up to 150 mg/kg/day.

Pregnancy

Teratogenic Effects

Pregnancy Category C

Carteolol hydrochloride (carteolol) increased resorptions and decreased fetal weights in rabbits and rats at maternally toxic doses approximately 1052 and 5264 times the maximum recommended human oral dose (10 mg/70 kg/day), respectively. A dose-related increase in wavy ribs was noted in the developing rat fetus when pregnant females received daily doses of approximately 212 times the maximum recommended human oral dose. No such effects were noted in pregnant mice subjected to up to 1052 times the maximum recommended human oral dose. There are no adequate and well-controlled studies in pregnant women. Carteolol Hydrochloride (carteolol) Ophthalmic Solution should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

Nursing Mothers

It is not known whether this drug is excreted in human milk, although in animal studies carteolol has been shown to be excreted in breast milk. Caution should be exercised when Carteolol Hydrochloride (carteolol) Ophthalmic Solution is administered to nursing mothers.

Pediatric Use

Safety and effectiveness in pediatric patients have not been established.

This monograph has been modified to include the generic and brand name in many instances.

OverDose

No specific information on emergency treatment of overdosage in humans is available. Should accidental ocular overdosage occur, flush eye(s) with water or normal saline. The most common effects expected with overdosage of a beta-adrenergic blocking agent are bradycardia, bronchospasm, congestive heart failure and hypotension.

In case of ingestion, treatment with Carteolol Hydrochloride (carteolol) Ophthalmic Solution should be discontinued and gastric lavage considered. The patient should be closely observed and vital signs carefully monitored. The prolonged effects of carteolol must be considered when determining the duration of corrective therapy. On the basis of the pharmacologic profile, the following additional measures should be considered as appropriate:

Symptomatic Sinus Bradycardia or Heart Block

Administer atropine. If there is no response to vagal blockade, administer isoproterenol cautiously.

Bronchospasm

Administer a beta2-stimulating agent such as isoproterenol and/or a theophylline derivative.

Congestive Heart Failure

Administer diuretics and digitalis glycosides as necessary.

Hypotension

Administer vasopressors such as intravenous dopamine, epinephrine or norepinephrine bitartrate.

ContrainDications

Carteolol is contraindicated in those individuals with bronchial asthma or with a history of bronchial asthma, or severe chronic obstructive pulmonary disease (see WARNINGS); sinus bradycardia; second- and third-degree atrioventricular block; overt cardiac failure (see WARNINGS); cardiogenic shock; or hypersensivity to any component of this product.

This monograph has been modified to include the generic and brand name in many instances.

Clinical Pharamacology

Carteolol is a nonselective beta-adrenergic blocking agent with associated intrinsic sympathomimetic activity and without significant membrane-stabilizing activity.

Carteolol Hydrochloride (carteolol) reduces normal and elevated intraocular pressure (IOP) whether or not accompanied by glaucoma. The exact mechanism of the ocular hypotensive effect of beta-blockers has not been definitely demonstrated.

In general, beta-adrenergic blockers reduce cardiac output in patients in good and poor cardiovascular health. In patients with severe impairment of myocardial function, beta-blockers may inhibit the sympathetic stimulation necessary to maintain adequate cardiac function. Beta-adrenergic blockers may also increase airway resistance in the bronchi and bronchioles due to unopposed parasympathetic activity.

Given topically twice daily in controlled domestic clinical trials ranging from 1.5 to 3 months, Carteolol Hydrochloride (carteolol) produced a median percent reduction of IOP 22% to 25%. No significant effects were noted on corneal sensitivity, tear secretion, or pupil size.

This monograph has been modified to include the generic and brand name in many instances.

Patient Information

For topical use only. To prevent contaminating the dropper tip and solution, care should be taken not to touch the eyelids or surrounding areas with the dropper tip of the bottle. Keep bottle tightly closed when not in use. Protect from light.

This monograph has been modified to include the generic and brand name in many instances.

Consumer Overview Uses

No Information Available!

Consumer Overview Side Effect

No Information Available!

Consumer Overview Missed Dose

No Information Available!

Patient Detailed Side Effect

Brand Names: Ocupress

Generic Name: carteolol ophthalmic (Pronunciation: kar TEE oh lol off THAL mik)

  • What is carteolol ophthalmic (Carteolol Hydrochloride)?
  • What are the possible side effects of carteolol ophthalmic (Carteolol Hydrochloride)?
  • What is the most important information I should know about carteolol ophthalmic (Carteolol Hydrochloride)?
  • What should I discuss with my healthcare provider before using carteolol ophthalmic (Carteolol Hydrochloride)?
  • How should I use carteolol ophthalmic (Carteolol Hydrochloride)?
  • What happens if I miss a dose (Carteolol Hydrochloride)?
  • What happens if I overdose (Carteolol Hydrochloride)?
  • What should I avoid while using carteolol ophthalmic (Carteolol Hydrochloride)?
  • What other drugs will affect carteolol ophthalmic (Carteolol Hydrochloride)?
  • Where can I get more information?

What is carteolol ophthalmic (Carteolol Hydrochloride)?

Carteolol is a beta-blocker that reduces pressure inside the eye.

Carteolol ophthalmic (for the eyes) is used to treat open-angle glaucoma and other causes of high pressure inside the eye.

Carteolol ophthalmic may also be used for other purposes not listed in this medication guide.

What are the possible side effects of carteolol ophthalmic (Carteolol Hydrochloride)?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Stop using this medication and call your doctor at once if you have any of these serious side effects:

  • severe swelling, itching, burning, redness, pain, or discomfort in or around your eye;
  • drainage, crusting, or oozing of your eyes or eyelids;
  • bronchospasm (wheezing, chest tightness, trouble breathing);
  • slow heart rate, weak pulse, fainting, slow breathing (breathing may stop);
  • fast or pounding heartbeats;
  • feeling short of breath, even with mild exertion; or
  • swelling, rapid weight gain.

Less serious side effects may include:

  • mild burning, stinging, itching, or watering of your eyes;
  • blurred or cloudy vision;
  • mildly swollen or puffy eyes;
  • increased sensitivity of your eyes to light;
  • trouble seeing at night;
  • droopy eyelids;
  • headache, dizziness, depression ;
  • muscle weakness;
  • sleep problems (insomnia);
  • stuffy nose; or
  • nausea, altered sense of taste.

This is not a complete list of side effects and others may occur. Tell your doctor about any unusual or bothersome side effect. You may report side effects to FDA at 1-800-FDA-1088.

Read the Carteolol Hydrochloride (carteolol) Side Effects Center for a complete guide to possible side effects

Learn More »

What is the most important information I should know about carteolol ophthalmic (Carteolol Hydrochloride)?

Do not use this medication if you are allergic to carteolol, or if you have asthma, or severe chronic obstructive pulmonary disease (COPD), or a heart condition called "AV block."

Before using this medication, tell your doctor if you have breathing problems such as bronchitis or emphysema, a history of heart disease or congestive heart failure, diabetes, history of stroke, blood clot, or circulation problems, a thyroid disorder, or a muscle disorder such as myasthenia gravis.

Do not allow the dropper to touch any surface, including the eyes or hands. If the dropper becomes contaminated it could cause an infection in your eye, which can lead to vision loss or serious damage to the eye.

Carteolol ophthalmic is sometimes given together with other eye medications to treat glaucoma. Do not use any other eye medication unless your doctor has prescribed it for you. If you use another eye medication, use it at least 10 minutes before or after using carteolol ophthalmic. Do not use the medications at the same time.

Carteolol ophthalmic can cause blurred vision. Be careful if you drive or do anything that requires you to be able to see clearly.

Do not use this medication while you are wearing contact lenses. Carteolol ophthalmic may contain a preservative that can be absorbed by soft contact lenses. Wait at least 15 minutes after using carteolol before putting your contact lenses in.

Side Effects Centers
  • Carteolol Hydrochloride

Patient Detailed How Take

What should I discuss with my healthcare provider before using carteolol ophthalmic (Carteolol Hydrochloride)?

Do not use this medication if you are allergic to carteolol, or if you have:

  • asthma, or severe chronic obstructive pulmonary disease (COPD);
  • slow heartbeats; or
  • a heart condition called "AV block."

If you have any of these other conditions, you may need a dose adjustment or special tests to safely use this medication:

  • breathing problems such as bronchitis or emphysema;
  • a history of heart disease or congestive heart failure;
  • diabetes;
  • history of stroke, blood clot, or circulation problems;
  • a thyroid disorder; or
  • a muscle disorder such as myasthenia gravis.

FDA pregnancy category C. It is not known whether carteolol ophthalmic is harmful to an unborn baby. Before using this medication, tell your doctor if you are pregnant or plan to become pregnant during treatment.

It is not known whether carteolol passes into breast milk or if it could harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby.

How should I use carteolol ophthalmic (Carteolol Hydrochloride)?

Use carteolol ophthalmic exactly as it was prescribed for you. Do not use the medication in larger amounts, or use it for longer than recommended by your doctor. Follow the instructions on your prescription label.

Wash your hands before using the eye drops.

Do not use this medication while you are wearing contact lenses. Carteolol ophthalmic may contain a preservative that can be absorbed by soft contact lenses. Wait at least 15 minutes after using carteolol before putting your contact lenses in.

To apply the eye drops:

  • Tilt your head back slightly and pull down your lower eyelid. Hold the dropper above the eye with the dropper tip down. Look up and away from the dropper as you squeeze out a drop, then close your eye.
  • Gently press your finger to the inside corner of the eye (near your nose) for about 1 minute to keep the liquid from draining into your tear duct. If you use more than one drop in the same eye, wait about 5 minutes before putting in the next drop.
  • Do not allow the dropper tip to touch any surface, including the eyes or hands. If the dropper becomes contaminated it could cause an infection in your eye, which can lead to vision loss or serious damage to the eye.

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

Tell your doctor right away if you have any eye injury or infection. If you have any type of surgery, including eye surgery, tell the surgeon ahead of time that you are using carteolol ophthalmic. You may need to stop using the medicine for a short time.

Store this medication at room temperature away from moisture, heat, and light. Keep the bottle tightly closed when not in use.

Side Effects Centers
  • Carteolol Hydrochloride

Patient Detailed Avoid Taking

What happens if I miss a dose (Carteolol Hydrochloride)?

Use the medication as soon as you remember. If it is almost time for the next dose, skip the missed dose and use the medicine at the next regularly scheduled time. Do not use extra medicine to make up the missed dose.

What happens if I overdose (Carteolol Hydrochloride)?

Seek emergency medical attention if you think you have used too much of this medicine.

Overdose symptoms may include slow heart rate, wheezing, feeling short of breath, swelling, rapid weight gain, or fainting.

What should I avoid while using carteolol ophthalmic (Carteolol Hydrochloride)?

Carteolol ophthalmic can cause blurred vision. Be careful if you drive or do anything that requires you to be able to see clearly.

Carteolol ophthalmic is sometimes given together with other eye medications to treat glaucoma. Do not use any other eye medication unless your doctor has prescribed it for you. If you use another eye medication, use it at least 10 minutes before or after using carteolol ophthalmic. Do not use the medications at the same time.

What other drugs will affect carteolol ophthalmic (Carteolol Hydrochloride)?

Before using carteolol ophthalmic, tell your doctor if you are using any of the following drugs:

  • oral carteolol (Blocadren);
  • digoxin (digitalis, Lanoxin);
  • reserpine;
  • insulin or diabetes medications you take by mouth;
  • any other beta-blocker such as atenolol (Tenormin), bisoprolol (Zebeta), labetalol (Normodyne, Trandate), metoprolol (Lopressor, Toprol), nadolol (Corgard), propranolol (Inderal, InnoPran), timolol (Blocadren), and others;
  • a calcium channel blocker such as amlodipine (Norvasc), diltiazem (Tiazac, Cartia, Cardizem), felodipine (Plendil), nifedipine (Nifedical, Procardia, Adalat), verapamil (Calan, Covera, Isoptin, Verelan); or
  • medicines to treat psychiatric disorders, such as chlorpromazine (Thorazine), haloperidol (Haldol), mesoridazine (Serentil), or thioridazine (Mellaril).

This list is not complete and there may be other drugs that can interact with carteolol ophthalmic. Tell your doctor about all the prescription and over-the-counter medications you use. This includes vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start using a new medication without telling your doctor.

Where can I get more information?

Your pharmacist can provide more information about carteolol ophthalmic.


Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.

Every effort has been made to ensure that the information provided by Cerner Multum, Inc. ('Multum') is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Multum's drug information does not endorse drugs, diagnose patients or recommend therapy. Multum's drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

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