What is Protevis 500?
Protevis 500 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.
Protevis 500 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.
Protevis 500 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.
Protevis 500 is available only with your doctor's prescription.
Protevis 500 indications
Hypertension
Protevis 500 (Protevis 500) 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
Protevis 500 (Protevis 500) 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
Protevis 500 (Protevis 500) is indicated for the prophylaxis of migraine headache.
How should I use Protevis 500?
Use Protevis 500 drops as directed by your doctor. Check the label on the medicine for exact dosing instructions.
- An extra patient leaflet is available with Protevis 500 drops. Talk to your pharmacist if you have questions about this information.
- Protevis 500 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 Protevis 500 drops. Remove contact lenses before you use Protevis 500 drops; lenses may be placed back in the eyes 15 minutes after use of Protevis 500 drops.
- To use Protevis 500 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 Protevis 500 drops at least 10 minutes before or after any other medicine that you put in your eye.
- Using Protevis 500 drops at the same time each day will help you remember to use it.
- Continue to use Protevis 500 drops even if you feel well. Do not miss any doses.
- If you miss a dose of Protevis 500 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 Protevis 500 drops.
Uses of Protevis 500 in details
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 Protevis 500 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.
Protevis 500 description
Each mL of Protevis 500 0.5% contains 5 mg of Protevis 500 (6.8 mg of Protevis 500 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 Protevis 500 contains the previously mentioned active and inactive ingredients except for the preservative benzododecinium bromide.
Protevis 500 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). Protevis 500 maleate possesses an asymmetric carbon atom and is provided as the levo isomer. The empirical formula is C13H24N403S·C4H404.
Protevis 500 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.
Protevis 500 dosage
Hypertension
The usual initial dosage of Protevis 500 (Protevis 500) 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.
Protevis 500 (Protevis 500) 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 Protevis 500 (Protevis 500) 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 Protevis 500 (Protevis 500) should be discontinued.
How supplied
No. 3343 — Tablets Protevis 500 (Protevis 500), 5 mg, are light blue, round, compressed tablets, with code MSD 59 on one side and Protevis 500 (Protevis 500) on the other. They are supplied as follows:
NDC 0006-0059-68 bottles of 100.
No. 3344 — Tablets Protevis 500 (Protevis 500), 10 mg, are light blue, round, scored, compressed tablets, with code MSD 136 on one side and Protevis 500 (Protevis 500) on the other. They are supplied as follows:
NDC 0006-0136-68 bottles of 100
No. 3371 — Tablets Protevis 500 (Protevis 500), 20 mg, are light blue, capsule shaped, scored, compressed tablets, with code MSD 437 on one side and Protevis 500 (Protevis 500) 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
Protevis 500 interactions
See also:
What other drugs will affect Protevis 500?
Protevis 500 should be used cautiously in patients with hyperthyroidism, hypertension and cardiac arrhythmias. All vasopressors should be used cautiously in patients taking monoamine oxidase (MAO) inhibitors.
Protevis 500 should not be administered concomitantly with other sympathomimetic drugs (such as isoproterenol) because of possible additive effects and increased toxicity.
Combined effects may induce serious cardiac arrhythmias. They may be administered alternately when the preceding effect of other such drug has subsided.
Administration of epinephrine to patients receiving cyclopropane or halogenated hydrocarbon general anesthetics such as halothane which sensitize the myocardium, may induce cardiac arrhythmia.. When encountered, such arrhythmias may respond to administration of a beta-adrenergic blocking drug. Protevis 500 also should be used cautiously with other drugs (e.g., digitalis, glycosides) that sensitize the myocardium to the actions of sympathomimetic drugs.
Diuretic agents may decrease vascular response to pressor drugs such as epinephrine.
Protevis 500 may antagonize the neuron blockade produced by guanethidine resulting in decreased antihypertensive effect and requiring increased dosage of the latter.
Protevis 500 side effects
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What are the possible side effects of Protevis 500?
Protevis 500 (Protevis 500) is usually well tolerated in properly selected patients. Most adverse effects have been mild and transient.
In a multicenter (12-week) clinical trial comparing Protevis 500 maleate and placebo in hypertensive patients, the following adverse reactions were reported spontaneously and considered to be causally related to Protevis 500 maleate:
Protevis 500 Maleate (n = 176) % | Placebo (n = 168) % | |
BODY AS A WHOLE | ||
fatigue/tiredness | 3.4 | 0.6 |
headache | 1.7 | 1.8 |
chest pain | 0.6 | 0 |
asthenia | 0.6 | 0 |
CARDIOVASCULAR | ||
bradycardia | 9.1 | 0 |
arrhythmia | 1.1 | 0.6 |
syncope | 0.6 | 0 |
edema | 0.6 | 1.2 |
DIGESTIVE | ||
dyspepsia | 0.6 | 0.6 |
nausea | 0.6 | 0 |
SKIN | ||
pruritus | 1.1 | 0 |
NERVOUS SYSTEM | ||
dizziness | 2.3 | 1.2 |
vertigo | 0.6 | 0 |
paresthesia | 0.6 | 0 |
PSYCHIATRIC | ||
decreased libido | 0.6 | 0 |
RESPIRATORY | ||
dyspnea | 1.7 | 0.6 |
bronchial spasm | 0.6 | 0 |
rales | 0.6 | 0 |
SPECIAL SENSES | ||
eye irritation | 1.1 | 0.6 |
tinnitus | 0.6 | 0 |
These data are representative of the incidence of adverse effects that may be observed in properly selected patients treated with Protevis 500 (Protevis 500), 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 Protevis 500 and placebo groups were
Adverse Reaction*** | 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 Protevis 500 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 Protevis 500 (Protevis 500), but reported with other beta-adrenergic blocking agents, should be considered potential adverse effects of Protevis 500 (Protevis 500) : 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 Protevis 500 (Protevis 500).
Clinical Laboratory Test Findings: Clinically important changes in standard laboratory parameters were rarely associated with the administration of Protevis 500 (Protevis 500). 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.
Protevis 500 contraindications
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What is the most important information I should know about Protevis 500?
Do not stop taking Protevis 500 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 Protevis 500. Be sure the surgeon knows ahead of time that you are using Protevis 500.
Protevis 500 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 Protevis 500.
Protevis 500 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.
Active ingredient matches for Protevis 500:
Timolol in Argentina.
List of Protevis 500 substitutes (brand and generic names) | Sort by popularity |
Unit description / dosage (Manufacturer) | Price, USD |
Protevis (Argentina) | |
Ratio-Timolol Maleate | |
Solution; Ophthalmic; Timolol Maleate 0.25% | |
Solution; Ophthalmic; Timolol Maleate 0.5% | |
Rhoxal-Timolol | |
Liquid; Ophthalmic; Timolol Maleate 0.25% | |
Liquid; Ophthalmic; Timolol Maleate 0.5% | |
Rysmon (Japan, South Korea) | |
Rysmon 0.25% (Japan) | |
Rysmon 0.5% (Japan) | |
Rysmon TG (Japan) | |
Rysmon TG 0.25% (Japan) | |
Rysmon TG 0.5% (Japan) | |
Sab-Timolol | |
Solution; Ophthalmic; Timolol Maleate 0.25% | |
Solution; Ophthalmic; Timolol Maleate 0.5% | |
Sandoz Timolol (Canada) | |
Solution; Ophthalmic; Timolol Maleate 0.25% | |
Solution; Ophthalmic; Timolol Maleate 0.5% | |
Sandoz Timolol solution 0.5 % (Sandoz Canada Incorporated (Canada)) | |
Sandoz Timolol solution 0.25 % (Sandoz Canada Incorporated (Canada)) | |
Shemol (Mexico) | |
Solution; Ophthalmic; Timolol Maleate 0.5% (Grin) | |
SIOTIM | |
SIOTIM EYE DROP 1 packet / 5 ML eye drop each (Albert David Ltd) | $ 0.61 |
Temlo (Bangladesh) | |
60ml (Zytras) | $ 0.30 |
15ml (Zytras) | $ 0.24 |
Drops; Oral; Acetaminophen (Zytras) | |
Suspension; Oral; Acetaminophen (Zytras) | |
TEMLO oral susp 125 mg x 5 mL x 60ml (Zytras) | $ 0.30 |
TEMLO oral drops 125 mg x 5 mL x 15ml (Zytras) | $ 0.24 |
Temserin (Greece) | |
Temserin 0.25% (Greece) | |
Tenopt (Australia) | |
Solution; Ophthalmic; Timolol Maleate 0.25% (Sigma) | |
Solution; Ophthalmic; Timolol Maleate 0.5% (Sigma) | |
Teoptic (India, Netherlands, United Kingdom) | |
Solution; Ophthalmic; Carteolol Hydrochloride 1% (Elder Pharmaceuticals Pvt Ltd) | |
Solution; Ophthalmic; Carteolol Hydrochloride 2% (Elder Pharmaceuticals Pvt Ltd) | |
Teoptic 0.25% DPS / 5ml (Elder Pharmaceuticals Pvt Ltd) | $ 0.19 |
Teoptic 0.5% DPS / 5ml (Elder Pharmaceuticals Pvt Ltd) | $ 0.27 |
0.25 % x 5ml (Elder Pharmaceuticals Pvt Ltd) | $ 0.19 |
0.5 % x 5ml (Elder Pharmaceuticals Pvt Ltd) | $ 0.27 |
Teoptic Eye 0.5% Drop (Elder Pharmaceuticals Pvt Ltd) | $ 0.27 |
Teoptic Eye 0.25% Drop (Elder Pharmaceuticals Pvt Ltd) | $ 0.19 |
TEOPTIC eye drops 0.25 % x 5ml (Elder Pharmaceuticals Pvt Ltd) | $ 0.19 |
TEOPTIC eye drops 0.5 % x 5ml (Elder Pharmaceuticals Pvt Ltd) | $ 0.27 |
Teva-Timolol (Canada) | |
Teva-timolol tablet 20 mg (Teva Canada Limited (Canada)) | |
Teva-timolol tablet 10 mg (Teva Canada Limited (Canada)) | |
Teva-timolol tablet 5 mg (Teva Canada Limited (Canada)) | |
See 784 substitutes for Protevis 500 |
References
- 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).
- PubChem. "timolol". https://pubchem.ncbi.nlm.nih.gov/com... (accessed September 17, 2018).
- DrugBank. "timolol". http://www.drugbank.ca/drugs/DB00373 (accessed September 17, 2018).
Reviews
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Information checked by Dr. Sachin Kumar, MD Pharmacology