Tapcom

Tafluprost (Tapcom) is indicated for reducing elevated intraocular pressure in patients with open-angle glaucoma or ocular hypertension. (elevated intraocular pressure;)

Hypertension

Timolol (Tapcom) (Timolol (Tapcom)) is indicated for the treatment of hypertension. It may be used alone or in combination with other antihypertensive agents, especially thiazide-type diuretics.

Myocardial Infarction

Timolol (Tapcom) (Timolol (Tapcom)) 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 (Tapcom) (Timolol (Tapcom)) is indicated for the prophylaxis of migraine headache.

Tafluprost (Tapcom) eye drops is used alone or together with other medicines to treat increased pressure in the eye caused by open-angle glaucoma or a condition called hypertension of the eye. Both conditions are caused by high pressure in the eye which can lead to pain or vision changes. Tafluprost (Tapcom) is a prostaglandin.

Tafluprost (Tapcom) is available only with your doctor's prescription.

Timolol (Tapcom) 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 (Tapcom) 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 (Tapcom) 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 (Tapcom) is available only with your doctor's prescription.

Usual Adult Dose for Intraocular Hypertension

One eye drop in the conjunctival sac of the affected eye(s) once a day in the evening

Comments:

-The dose should not exceed one drop in the affected eye(s) daily as more frequent administration may lessen the intraocular pressure lowering effect.

-This drug may be used concomitantly with other topical ophthalmic drugs to lower intraocular pressure.

-If more than one topical ophthalmic drug is being used, each one should be administered at least 5 minutes apart.

-Reduction of the intraocular pressure starts approximately 2 to 4 hours after the first administration with the maximum effect reached after 12 hours.

Use:

-Reduction of elevated intraocular pressure (IOP) in patients with open-angle glaucoma or ocular hypertension

Usual Adult Dose for Glaucoma (Open Angle)

One eye drop in the conjunctival sac of the affected eye(s) once a day in the evening

Comments:

-The dose should not exceed one drop in the affected eye(s) daily as more frequent administration may lessen the intraocular pressure lowering effect.

-This drug may be used concomitantly with other topical ophthalmic drugs to lower intraocular pressure.

-If more than one topical ophthalmic drug is being used, each one should be administered at least 5 minutes apart.

-Reduction of the intraocular pressure starts approximately 2 to 4 hours after the first administration with the maximum effect reached after 12 hours.

Use:

-Reduction of elevated intraocular pressure (IOP) in patients with open-angle glaucoma or ocular hypertension

Renal Dose Adjustments

Data not available

Liver Dose Adjustments

Data not available

Precautions

Safety and efficacy have not been established in patients younger than 18 years.

Consult WARNINGS section for additional precautions.

Dialysis

Data not available

Other Comments

Storage requirements:

-Store in refrigerator (2 to 8 C/36 to 46 F)

-After the pouch is opened, the single-use containers may be stored in the opened foil pouch for up to 28 days at room temperature (20 to 25 C/68 to 77 F).

-Protect from moisture

-Protect from light

-Discard an opened single-dose container with any remaining solution immediately after use.

Patient Advice:

-You should wipe off any excess solution from the skin to reduce the risk of darkening of the eyelid skin.

-As with any other eye drops, nasolacrimal occlusion or gently closing the eyelid after administration is recommended. This may reduce the systemic absorption of medicinal products administered via the ocular route.

-If more than one topical ophthalmic medicinal product is being used, each one should be administered at least 5 minutes apart

Hypertension

The usual initial dosage of Timolol (Tapcom) (Timolol (Tapcom)) 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 20-40 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 seven days between increases in dosages.

Timolol (Tapcom) (Timolol (Tapcom)) 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.

Migraine

The usual initial dosage of Timolol (Tapcom) (Timolol (Tapcom)) 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 6-8 weeks use of the maximum daily dosage, therapy with Timolol (Tapcom) (Timolol (Tapcom)) should be discontinued.

How supplied

No. 3343 — Tablets Timolol (Tapcom) (Timolol (Tapcom)), 5 mg, are light blue, round, compressed tablets, with code MSD 59 on one side and Timolol (Tapcom) (Timolol (Tapcom)) on the other. They are supplied as follows:

NDC 0006-0059-68 bottles of 100.

No. 3344 — Tablets Timolol (Tapcom) (Timolol (Tapcom)), 10 mg, are light blue, round, scored, compressed tablets, with code MSD 136 on one side and Timolol (Tapcom) (Timolol (Tapcom)) on the other. They are supplied as follows:

NDC 0006-0136-68 bottles of 100

No. 3371 — Tablets Timolol (Tapcom) (Timolol (Tapcom)), 20 mg, are light blue, capsule shaped, scored, compressed tablets, with code MSD 437 on one side and Timolol (Tapcom) (Timolol (Tapcom)) on the other. They are supplied as follows:

NDC 0006-0437-68 bottles of 100

Storage

Store at controlled room temperature, 15-30°C (59-86°F). Keep container tightly closed. Protect from light.

MERCK AND CO., INC., Whitehouse Station, NJ 08889, USA. Issued April 2001. FDA Rev date: 2/25/2003

See also:
What is the most important information I should know about Tafluprost (Tapcom)?

Hypersensitivity to Tafluprost (Tapcom) or to any of the excipients of Tafluprost (Tapcom).

See also:
What is the most important information I should know about Timolol (Tapcom)?

Do not stop taking Timolol (Tapcom) without first talking to your doctor. Stopping suddenly may make your condition worse.

If you need to have any type of surgery, you may need to temporarily stop using Timolol (Tapcom). Be sure the surgeon knows ahead of time that you are using Timolol (Tapcom).

Timolol (Tapcom) can cause side effects that may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be awake and alert.

Avoid drinking alcohol, which could increase drowsiness and dizziness while you are taking Timolol (Tapcom).

Timolol (Tapcom) is only part of a complete program of treatment for hypertension that may also include diet, exercise, and weight control. Follow your diet, medication, and exercise routines very closely if you are being treated for hypertension.

Hypertension often has no symptoms, so you may not even feel that you have high blood pressure. Continue using this medicine as directed, even if you feel well. You may need to use blood pressure medication for the rest of your life.

Use Tafluprost (Tapcom) as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• An extra patient leaflet is available with Tafluprost (Tapcom). Talk to your pharmacist if you have questions about this information.
• Use Tafluprost (Tapcom) in the evening unless your doctor tells you otherwise.
• Do not open the pouch containing Tafluprost (Tapcom) until you are ready to use the eye drops.
• To use Tafluprost (Tapcom) in the eye, first, wash your hands. Tilt your head back. If you are unable to tilt your head, lie down. Using your index finger, pull the lower eyelid away from the eye to form a pouch and look up. Drop the medicine into the pouch and gently close your eyes. If a drop misses your eye, try again. Immediately use your finger to apply pressure to the inside corner of the eyelid for 1 to 2 minutes. Do not blink. Remove excess medicine around your eye with a clean, dry tissue, being careful not to touch your eye. Wash your hands to remove any medicine that may be on them.
• There is enough medicine in one container for both of your eyes.
• To prevent germs from contaminating your medicine, do not touch the applicator tip to any surface, including the eye.
• Use Tafluprost (Tapcom) at least 5 minutes apart from any other medicine that you put in your eye.
• Each container of Tafluprost (Tapcom) is intended for a single use only. Use right away after opening. After you have opened the container and used it, throw away any remaining medicine immediately. Do not save it to use at a later time.
• Continue to use Tafluprost (Tapcom) even if you feel well. Do not miss any doses.
• If you miss a dose of Tafluprost (Tapcom), use it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not use 2 doses at once.

Ask your health care provider any questions you may have about how to use Tafluprost (Tapcom).

Use Timolol (Tapcom) drops as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• An extra patient leaflet is available with Timolol (Tapcom) drops. Talk to your pharmacist if you have questions about this information.
• Timolol (Tapcom) drops is only for the eye. Do not get it in your nose or mouth.
• Soft contact lenses may absorb a chemical contained in some brands of Timolol (Tapcom) drops. Remove contact lenses before you use Timolol (Tapcom) drops; lenses may be placed back in the eyes 15 minutes after use of Timolol (Tapcom) drops.
• To use Timolol (Tapcom) drops in the eye, first, wash your hands. Tilt your head back. Using your index finger, pull the lower eyelid away from the eye to form a pouch. Drop the medicine into the pouch and gently close your eyes. Immediately use your finger to apply pressure to the inside corner of the eye for 1 to 2 minutes. Do not blink. Remove excess medicine around your eye with a clean, dry tissue, being careful not to touch your eye. Wash your hands to remove any medicine that may be on them.
• To prevent germs from contaminating your medicine, do not touch the applicator tip to any surface, including the eye. Keep the container tightly closed.
• Use Timolol (Tapcom) drops at least 10 minutes before or after any other medicine that you put in your eye.
• Using Timolol (Tapcom) drops at the same time each day will help you remember to use it.
• Continue to use Timolol (Tapcom) drops even if you feel well. Do not miss any doses.
• If you miss a dose of Timolol (Tapcom) drops, use it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not use 2 doses at once.

Ask your health care provider any questions you may have about how to use Timolol (Tapcom) drops.

Tafluprost (Tapcom) is used to treat high pressure inside the eye due to glaucoma (open-angle type) or other eye diseases (such as ocular hypertension). Lowering high pressure inside the eye can help prevent blindness. This medication works by regulating the flow of fluid within the eye to maintain a normal pressure.

How to use Tafluprost (Tapcom) (PF) ophthalmic

Read the Patient Information Leaflet if available from your pharmacist before you start using Tafluprost (Tapcom) and each time you get a refill. If you have any questions, ask your doctor or pharmacist.

Apply this medication in the affected eye(s) as directed by your doctor, usually once daily in the evening. Do not use this medication more frequently than prescribed; using more can make it work less well.

To apply eye drops, wash your hands first. To avoid contamination, do not touch the dropper tip or let it touch your eye or any other surface.

Tilt your head back, look upward, and pull down the lower eyelid to make a pouch. Hold the dropper directly over your eye and place one drop into the pouch. Look downward, gently close your eyes, and place one finger at the corner of your eye (near the nose). Apply gentle pressure for 1 to 2 minutes before opening your eyes. This will prevent the medication from draining out. Try not to blink or rub your eye. Repeat these steps for your other eye if so directed. Wait several minutes for your vision to clear before driving or operating machinery.

If you are using another kind of eye medication (such as drops or ointments), wait at least 5 minutes before applying other medications. Use eye drops before eye ointments to allow the drops to enter the eye.

Use this medication regularly to get the most benefit from it. Remember to use it at the same time each day. It is important to continue using Tafluprost (Tapcom) even if you feel well. Most people with glaucoma or high pressure in the eye do not have symptoms.

Use: Labeled Indications

Hypertension: Management of hypertension. Note: Beta-blockers are not recommended as first-line therapy (ACC/AHA [Whelton 2017]).

Migraine prophylaxis: Prophylaxis of migraine

Myocardial infarction (secondary prevention): To reduce mortality following MI

Off Label Uses

Atrial fibrillation (rate-control)

Data from a randomized, placebo-controlled trial in patients with atrial fibrillation (AF) associated with a rapid ventricular response while receiving digoxin supports the use of oral Timolol (Tapcom) in patients with chronic AF.

Based on the 2014 AHA/ACC/HRS guideline for the management of patients with AF, the use of beta-blockers for ventricular rate control in patients with paroxysmal, persistent, or permanent AF is effective and recommended for this condition.

No interactions are anticipated in humans, since systemic concentrations of Tafluprost (Tapcom) are extremely low following ocular dosing. Therefore, specific interaction studies with other medicinal products have not been performed with Tafluprost (Tapcom). In clinical studies, Tafluprost (Tapcom) was used concomitantly with timolol without evidence of interaction.

See also:
What other drugs will affect Timolol (Tapcom)?

Beta-adrenergic blocking agents: Patients who are receiving a beta-adrenergic blocking agent orally and Timolol (Tapcom) GFS should be observed for potential additive effects of beta-blockade, both systemic and on intraocular pressure. Patients should not usually receive two topical ophthalmic beta-adrenergic blocking agents concurrently.

Calcium antagonists: Caution should be used in the co-administration of beta-adrenergic blocking agents, such as Timolol (Tapcom) GFS, and oral or intravenous calcium antagonists because of possible atrioventricular conduction disturbances, left ventricular failure, or hypotension. In patients with impaired cardiac function, co-administration should be avoided.

ENDOCRINE

Masked symptoms of hypoglycemia in diabetic patients. SPECIAL SENSES

Signs and symptoms of ocular irritation including blepharitis, keratitis, and dry eyes; ptosis; decreased corneal sensitivity; cystoid macular edema; visual disturbances including refractive changes and diplopia; pseudopemphigoid; tinnitus and choroidal detachment following filtration surgery.

UROGENITAL

Retroperitoneal fibrosis, decreased libido, impotence and Peyronieís disease.

The following additional adverse effects have been reported in clinical experience with ORAL Timolol (Tapcom) maleate or other ORAL beta-blocking agents and may be considered potential effects of ophthalmic Timolol (Tapcom) maleate: Allergic: Erythematous rash, fever combined with aching and sore throat, laryngospasm with respiratory distress; Body as a Whole: Extremity pain, decreased exercise tolerance, weight loss; Cardiovascular: Worsening of arterial insufficiency, vasodilatation; Digestive: Gastrointestinal pain, hepatomegaly, vomiting, mesenteric arterial thrombosis, ischemic colitis; Hematologic: Nonthrombocytopenic purpura, thrombocytopenic purpura, agranulocytosis; Endocrine: Hyperglycemia, hypoglycemia; Skin: Pruritus, skin irritation, increased pigmentation, sweating; Musculoskeletal: Arthralgia; Nervous System/Psychiatric: Vertigo, local weakness, diminished concentration, reversible mental depression progressing to catatonia, an acute reversible syndrome characterized by disorientation for time and place, emotional lability, slightly clouded sensorium, and decreased performance on neuropsychometric tests; Respiratory: Rales, bronchial obstruction; Urogenital: Urination difficulties.

See also:
What are the possible side effects of Tafluprost (Tapcom)?

Applies to Tafluprost (Tapcom) ophthalmic: ophthalmic solution

As well as its needed effects, Tafluprost (Tapcom) ophthalmic may cause unwanted side effects that require medical attention.

Major Side Effects

If any of the following side effects occur while taking Tafluprost (Tapcom) ophthalmic, check with your doctor immediately:

Less common:

• Blurred vision
• burning, dry, or itching eyes
• decreased vision
• eye discharge or excessive tearing
• eye pain
• redness, pain, or swelling of the eye, eyelid, or inner lining of the eyelid

Minor Side Effects

Some Tafluprost (Tapcom) ophthalmic side effects may not need any medical attention. As your body gets used to the medicine these side effects may disappear. Your health care professional may be able to help you prevent or reduce these side effects, but do check with them if any of the following side effects continue, or if you are concerned about them:

More common:

• Headache
• stinging or irritation of the eye

• Cough
• darker color of the eyelashes
• dry eyes
• increased growth of the eyelashes

See also:
What are the possible side effects of Timolol (Tapcom)?

Timolol (Tapcom) (Timolol (Tapcom)) is usually well tolerated in properly selected patients. Most adverse effects have been mild and transient.

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

These data are representative of the incidence of adverse effects that may be observed in properly selected patients treated with Timolol (Tapcom) (Timolol (Tapcom)), 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, the frequency of the principal adverse reactions and the frequency with which these resulted in discontinuation of therapy in the Timolol (Tapcom) 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 (Tapcom) 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 (Tapcom) (Timolol (Tapcom)), but reported with other beta-adrenergic blocking agents, should be considered potential adverse effects of Timolol (Tapcom) (Timolol (Tapcom)) : 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; 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 (Tapcom) (Timolol (Tapcom)).

Clinical Laboratory Test Findings: Clinically important changes in standard laboratory parameters were rarely associated with the administration of Timolol (Tapcom) (Timolol (Tapcom)). 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.

A prostaglandin analogue ester prodrug used topically (as eye drops) to control the progression of glaucoma and in the management of ocular hypertension. Chemically, Tafluprost (Tapcom) is a fluorinated analog of prostaglandin F2-alpha. Tafluprost (Tapcom) was approved for use in the U.S. on February 10, 2012.

Each mL of Timolol (Tapcom) 0.5% contains 5 mg of Timolol (Tapcom) (6.8 mg of Timolol (Tapcom) maleate). It also contains the following inactive ingredients: Gellan gum, tromethamine, mannitol and water for injection. Benzododecinium bromide 0.012% is added as preservative.

Preservative-free Timolol (Tapcom) contains the previously mentioned active and inactive ingredients except for the preservative benzododecinium bromide.

Timolol (Tapcom) maleate is a β-adrenergic receptor blocking agent. It is (S)-1-[(1,1-dimethylethyl)amino]-3-[[4-(4-morpholinyl)-1,2,5-thiadiazol-3-yl]oxy]-2-propanol (Z)-2-butenedioate (1:1) (salt). Timolol (Tapcom) maleate possesses an asymmetric carbon atom and is provided as the levo isomer. The empirical formula is C₁₃H₂₄N₄0₃S·C₄H₄0₄.

Timolol (Tapcom) maleate has a molecular weight of 432.50. It is a white, odourless, crystalline powder which is soluble in water, methanol and alcohol.

Gellan solution contains a highly purified anionic heteropolysaccharide derived from gellan gum. Aqueous solutions of gellan gum form a clear transparent gel in the presence of cations. The concentration of sodium cations in tears is ideally suited to cause gelation of the material when topically instilled in the conjunctival sac.