Optilax 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.
Optilax 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.
Optilax 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.
Optilax is available only with your doctor's prescription.
An indication is a term used for the list of condition or symptom or illness for which the medicine is prescribed or used by the patient. For example, acetaminophen or paracetamol is used for fever by the patient, or the doctor prescribes it for a headache or body pains. Now fever, headache and body pains are the indications of paracetamol. A patient should be aware of the indications of medications used for common conditions because they can be taken over the counter in the pharmacy meaning without prescription by the Physician.
Optilax (Optilax) is indicated for the treatment of hypertension. It may be used alone or in combination with other antihypertensive agents, especially thiazide-type diuretics.
Optilax (Optilax) 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.
Optilax (Optilax) is indicated for the prophylaxis of migraine headache.
How should I use Optilax?
Use Optilax drops as directed by your doctor. Check the label on the medicine for exact dosing instructions.
An extra patient leaflet is available with Optilax drops. Talk to your pharmacist if you have questions about this information.
Optilax 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 Optilax drops. Remove contact lenses before you use Optilax drops; lenses may be placed back in the eyes 15 minutes after use of Optilax drops.
To use Optilax 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 Optilax drops at least 10 minutes before or after any other medicine that you put in your eye.
Using Optilax drops at the same time each day will help you remember to use it.
Continue to use Optilax drops even if you feel well. Do not miss any doses.
If you miss a dose of Optilax 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 Optilax drops.
Uses of Optilax in details
There are specific as well as general uses of a drug or medicine. A medicine can be used to prevent a disease, treat a disease over a period or cure a disease. It can also be used to treat the particular symptom of the disease. The drug use depends on the form the patient takes it. It may be more useful in injection form or sometimes in tablet form. The drug can be used for a single troubling symptom or a life-threatening condition. While some medications can be stopped after few days, some drugs need to be continued for prolonged period to get the benefit from it.
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 Optilax 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.
Each mL of Optilax 0.5% contains 5 mg of Optilax (6.8 mg of Optilax 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 Optilax contains the previously mentioned active and inactive ingredients except for the preservative benzododecinium bromide.
Optilax 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). Optilax maleate possesses an asymmetric carbon atom and is provided as the levo isomer. The empirical formula is C13H24N403S·C4H404.
Optilax 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.
The usual initial dosage of Optilax (Optilax) 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.
Optilax (Optilax) may be used with a thiazide diuretic or with other antihypertensive agents. Patients should be observed carefully during initiation of such concomitant therapy.
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.
The usual initial dosage of Optilax (Optilax) 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 Optilax (Optilax) should be discontinued.
No. 3343 — Tablets Optilax (Optilax), 5 mg, are light blue, round, compressed tablets, with code MSD 59 on one side and Optilax (Optilax) on the other. They are supplied as follows:
NDC 0006-0059-68 bottles of 100.
No. 3344 — Tablets Optilax (Optilax), 10 mg, are light blue, round, scored, compressed tablets, with code MSD 136 on one side and Optilax (Optilax) on the other. They are supplied as follows:
NDC 0006-0136-68 bottles of 100
No. 3371 — Tablets Optilax (Optilax), 20 mg, are light blue, capsule shaped, scored, compressed tablets, with code MSD 437 on one side and Optilax (Optilax) on the other. They are supplied as follows:
NDC 0006-0437-68 bottles of 100
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
Beta-adrenergic blocking agents: Patients who are receiving a beta-adrenergic blocking agent orally and Nu-Optilax 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 Nu-Optilax 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.
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.
Retroperitoneal fibrosis, decreased libido, impotence and Peyronieís disease.
The following additional adverse effects have been reported in clinical experience with ORAL Optilax maleate or other ORAL beta-blocking agents and may be considered potential effects of ophthalmic Optilax 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.
Optilax (Optilax) is usually well tolerated in properly selected patients. Most adverse effects have been mild and transient.
In a multicenter (12-week) clinical trial comparing Optilax maleate and placebo in hypertensive patients, the following adverse reactions were reported spontaneously and considered to be causally related to Optilax maleate:
(n = 176)
(n = 168)
BODY AS A WHOLE
These data are representative of the incidence of adverse effects that may be observed in properly selected patients treated with Optilax (Optilax), 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 Optilax and placebo groups were
WithdrawalOnly principal reason for withdrawal in each patient is listed. These adverse reactions can also occur in patients treated for hypertension.
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 Optilax 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 Optilax (Optilax), but reported with other beta-adrenergic blocking agents, should be considered potential adverse effects of Optilax (Optilax) : 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 Optilax (Optilax).
Clinical Laboratory Test Findings: Clinically important changes in standard laboratory parameters were rarely associated with the administration of Optilax (Optilax). 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.
Do not stop taking Optilax 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 Optilax. Be sure the surgeon knows ahead of time that you are using Optilax.
Optilax 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 Optilax.
Optilax 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.
DailyMed. "TIMOLOL: DailyMed provides trustworthy information about marketed drugs in the United States. DailyMed is the official provider of FDA label information (package inserts).". https://dailymed.nlm.nih.gov/dailyme... (accessed September 17, 2018).
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