Timolol

Tell your doctor about all prescription, nonprescription, illegal, recreational, herbal, nutritional, or dietary drugs you're taking, especially:

• Aspirin and other nonsteroidal anti-inflammatory drugs (NSAIDs), such as Advil or Motrin (ibuprofen), Aleve or Naprosyn (naproxen), and Indocin or Indo-Lemmon (indomethacin)
• Catapres, Kapvay, or Clorpres (clonidine and chlorthalidone)
• Lanoxin (digoxin)
• Adrenaclick or EpiPen (epinephrine)
• Cardizem, Cartia XT, Dilacor, or Tiazac (diltiazem)
• Medication for glaucoma
• Adalat, Afeditab CR, or Procardia (nifedipine)
• Quinidine
• Reserpine
• Calan, Covera, or Verelan (verapamil)
• Other medication for high blood pressure or heart disease
• Cold medicines, stimulants, or diet pills
• Diabetes medicines
• Cocaine

Timolol and Other Interactions

Timolol can cause dizziness or drowsiness.

Don't drive, operate machinery, or perform other activities that require alertness until you know how this medicine affects you.

Timolol and Alcohol

Alcohol can worsen certain side effects of timolol.

Talk to your doctor before drinking alcoholic beverages while taking this medicine.

Timolol may be found in some form under the following brand names:

• Betimol

• Blocadren

• Combigan

• Cosopt

• Istalol

• Timoptic

Tell your doctor about all the medicines you take including prescription and non-prescription medicines, vitamins, and herbal supplements. Especially tell your doctor if you take:

• ACETOHEXAMIDE/TIMOLOL
• ALLERGENIC EXTRACT, BEE/TIMOLOL
• CHLORPROPAMIDE/TIMOLOL
• CLONIDINE/TIMOLOL
• DISOPYRAMIDE/TIMOLOL
• EPINEPHRINE/TIMOLOL
• FELODIPINE/TIMOLOL
• FINGOLIMOD/TIMOLOL
• GLIPIZIDE/TIMOLOL
• GLYBURIDE/TIMOLOL
• INDOMETHACIN/TIMOLOL
• INSULIN/TIMOLOL
• PIROXICAM/TIMOLOL
• QUINIDINE/TIMOLOL
• SULINDAC/TIMOLOL
• TIMOLOL/TOLAZAMIDE
• TIMOLOL/TOLBUTAMIDE
• TIMOLOL/VERAPAMIL

This is not a complete list of Timololdrug interactions. Ask your doctor or pharmacist for more information.

You should not use timolol if you are allergic to it, or if you have:

• asthma, chronic obstructive pulmonary disease (COPD), sleep apnea, or other breathing disorder;

• a serious heart condition such as "AV block" (second or third degree);

• very slow heartbeats; or

• heart failure.

To make sure timolol is safe for you, tell your doctor if you have:

• congestive heart failure;

• coronary artery disease (hardened arteries);

• diabetes;

• overactive thyroid;

• liver or kidney disease;

• myasthenia gravis or other muscle disorders;

• allergies (or if you are undergoing allergy treatments or skin-testing);

• peripheral vascular disease such as Raynaud's syndrome; or

• a condition for which you are being treated with IV heart or blood pressure medication (such as diltiazem, nicardipine, or verapamil).

It is not known whether this medicine will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant.

Timolol can pass into breast milk and may harm a nursing baby. You should not breast-feed while using this medicine.

Timolol is not approved for use by anyone younger than 18 years old.

Timolol is used alone or together with other medicines (such as hydrochlorothiazide) to treat high blood pressure (hypertension). High blood pressure adds to the workload of the heart and arteries. If it continues for a long time, the heart and arteries may not function properly. This can damage the blood vessels of the brain, heart, and kidneys, resulting in a stroke, heart failure, or kidney failure. High blood pressure may also increase the risk of heart attacks. These problems may be less likely to occur if blood pressure is controlled .

Timolol is also used after an acute heart attack to decrease its severity and prevent another heart attack. It may also be used to help prevent migraine headaches .

timolol is a beta-blocker. It works by affecting the response to nerve impulses in certain parts of the body, like the heart. As a result, the heart beats slower and decreases the blood pressure. When the blood pressure is lowered, the amount of blood and oxygen is increased to the heart .

timolol is available only with your doctor's prescription .

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

• Chest pain or discomfort
• lightheadedness, dizziness, or fainting
• shortness of breath
• slow or irregular heartbeat
• unusual tiredness

• Difficult or labored breathing
• fast heartbeat
• tightness in chest
• wheezing

• Noisy breathing
• small clicking, bubbling, or rattling sounds in the lung when listening with a stethoscope
• swelling of hands, ankles, feet, or lower legs

Get emergency help immediately if any of the following symptoms of overdose occur:

• Blurred vision
• continuing ringing or buzzing or other unexplained noise in ears
• headache
• hearing loss
• nervousness
• pounding in the ears
• sweating

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

• Itching skin
• red, sore eyes

• Acid or sour stomach
• belching
• burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings
• decreased interest in sexual intercourse
• feeling of constant movement of self or surroundings
• heartburn
• inability to have or keep an erection
• indigestion
• lack or loss of strength
• loss in sexual ability, desire, drive, or performance
• nausea
• sensation of spinning
• stomach discomfort, upset, or pain

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

Hypertension

Timolol maleate tablets are indicated for the treatment of hypertension. They may be used alone or in combination with other antihypertensive agents, especially thiazide-type diuretics.

Myocardial Infarction

Timolol is indicated in patients who have survived the acute phase of myocardial infarction, and are clinically stable, to reduce cardiovascular mortality and the risk of reinfarction.

Migraine

Timolol is indicated for the prophylaxis of migraine headache.

Timolol maleate is contraindicated in patients 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; hypersensitivity to this product.

Timolol maleate tablets are usually well tolerated in properly selected patients. Most adverse effects have been mild and transient.

In a multi-center (12 week) clinical trial comparing Timolol maleate and placebo in hypertensive patients, the following adverse reactions were reported spontaneously and considered to be causally related to Timolol maleate:

These data are representative of the incidence of adverse effects that may be observed in properly selected patients treated with Timolol maleate, i.e., excluding patients with bronchospastic disease, congestive heart failure or other contraindications to beta-blocker therapy.

In patients with migraine the incidence of bradycardia was 5 percent.

In a coronary artery disease population studied in the Norwegian multi-center trial (see CLINICAL PHARMACOLOGY), the frequency of the principal adverse reactions and the frequency with which these resulted in discontinuation of therapy in the Timolol and placebo groups were:

The following additional adverse effects have been reported in clinical experience with the drug: Body as a Whole: anaphylaxis, extremity pain, decreased exercise tolerance, weight loss, fever; Cardiovascular: cardiac arrest, cardiac failure, cerebral vascular accident, worsening of angina pectoris, worsening of arterial insufficiency, Raynaud's phenomenon, palpitations, vasodilatation; Digestive: gastrointestinal pain, hepatomegaly, vomiting, diarrhea, dyspepsia; Hematologic: nonthrombocytopenic purpura; Endocrine: hyperglycemia, hypoglycemia; Skin: rash, skin irritation, increased pigmentation, sweating, alopecia; Musculoskeletal: arthralgia; Nervous System: local weakness, increase in signs and symptoms of myasthenia gravis; Psychiatric: depression, nightmares, somnolence, insomnia, nervousness, diminished concentration, hallucinations; Respiratory: cough; Special Senses: visual disturbances, diplopia, ptosis, dry eyes; Urogenital: impotence, urination difficulties.

There have been reports of retroperitoneal fibrosis in patients receiving Timolol maleate and in patients receiving other beta-adrenergic blocking agents. A causal relationship between this condition and therapy with beta-adrenergic blocking agents has not been established.

Potential Adverse Effects

In addition, a variety of adverse effects not observed in clinical trials with Timolol maleate, but reported with other beta-adrenergic blocking agents, should be considered potential adverse effects of Timolol. Nervous System: Reversible mental depression progressing to catatonia; an acute reversible syndrome characterized by disorientation for time and place, short-term memory loss, emotional lability, slightly clouded sensorium, and decreased performance on neuropsychometrics; Cardiovascular: Intensification of AV block (see CONTRAINDICATIONS); Digestive: Mesenteric arterial thrombosis, ischemic colitis; Hematologic: Agranulocytosis, thrombocytopenic purpura; Allergic: Erythematous rash, fever combined with aching and sore throat, laryngospasm with respiratory distress; Miscellaneous: Peyronie's disease.

There have been reports of a syndrome comprising psoriasiform skin rash, conjunctivitis sicca, otitis, and sclerosing serositis attributed to the beta-adrenergic receptor blocking agent, practolol. This syndrome has not been reported with Timolol.

Clinical Laboratory Test Findings

Clinically important changes in standard laboratory parameters were rarely associated with the administration of Timolol. Slight increases in blood urea nitrogen, serum potassium, uric acid, and triglycerides, and slight decreases in hemoglobin, hematocrit and HDL cholesterol occurred, but were not progressive or associated with clinical manifestations. Increases in liver function tests have been reported.

Hypertension

The usual initial dosage of Timolol maleate is 10 mg twice a day, whether used alone or added to diuretic therapy. Dosage may be increased or decreased depending on heart rate and blood pressure response. The usual total maintenance dosage is 20 to 40 mg per day. Increases in dosage to a maximum of 60 mg per day divided into two doses may be necessary. There should be an interval of at least 7 days between increases in dosages.

Timolol maleate tablets may be used with a thiazide diuretic or with other antihypertensive agents. Patients should be observed carefully during initiation of such concomitant therapy.

Myocardial Infarction

The recommended dosage for long-term prophylactic use in patients who have survived the acute phase of a myocardial infarction is 10 mg given twice daily (see CLINICAL PHARMACOLOGY).

Migraine

The usual initial dosage of Timolol maleate is 10 mg twice a day. During maintenance therapy the 20 mg daily dosage may be administered as a single dose. Total daily dosage may be increased to a maximum of 30 mg, given in divided doses, or decreased to 10 mg once per day, depending on clinical response and tolerability. If a satisfactory response is not obtained after 6 to 8 weeks use of the maximum daily dosage, therapy with Timolol should be discontinued.

More frequently reported side effects include: cardiac failure and asthenia. See below for a comprehensive list of adverse effects.

Initial dose: 10 mg orally twice a day

Use: For patients who have survived the acute phase of myocardial infarction, and are clinically stable, to reduce cardiovascular mortality and the risk of reinfarction