What is Timoptic in Ocudose?
Timoptic in Ocudose 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.
Timoptic in Ocudose 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.
Timoptic in Ocudose 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.
Timoptic in Ocudose is available only with your doctor's prescription.
Timoptic in Ocudose indications
Hypertension
Timoptic in Ocudose 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
Timoptic in Ocudose 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
Timoptic in Ocudose is indicated for the prophylaxis of migraine headache.
How should I use Timoptic in Ocudose?
Use Timoptic in Ocudose as directed by your doctor. Check the label on the medicine for exact dosing instructions.
- Take Timoptic in Ocudose by mouth with or without food.
- If you miss a dose of Timoptic in Ocudose, take 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 take 2 doses at once.
Ask your health care provider any questions you may have about how to use Timoptic in Ocudose.
Uses of Timoptic in Ocudose 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 Timoptic in Ocudose 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.
Timoptic in Ocudose description
A beta-adrenergic antagonist similar in action to propranolol. The levo-isomer is the more active. Timoptic in Ocudose has been proposed as an antihypertensive, antiarrhythmic, antiangina, and antiglaucoma agent. It is also used in the treatment of migraine disorders and tremor.
Timoptic in Ocudose dosage
Patients should be instructed to invert the closed container and shake once before each use. It is not necessary to shake the container more than once. Other topically applied ophthalmic medications should be administered at least 10 minutes before Timoptic in Ocudose Ophthalmic Gel Forming Solution.
Timoptic in Ocudose Ophthalmic Gel Forming Solution is available in concentrations of 0.25% and 0.5%. The dose is one drop of Timoptic in Ocudose Ophthalmic Gel Forming Solution (either 0.25% or 0.5%) in the affected eye(s) once a day.
Because in some patients the pressure-lowering response to Timoptic in Ocudose Ophthalmic Gel Forming Solution may require a few weeks to stabilize, evaluation should include a determination of intraocular pressure after approximately 4 weeks of treatment with Timoptic in Ocudose Ophthalmic Gel Forming Solution.
Dosages higher than one drop of 0.5% Timoptic in Ocudose Ophthalmic Gel Forming Solution once a day have not been studied. If the patient's intraocular pressure is still not at a satisfactory level on this regimen, concomitant therapy can be considered. The concomitant use of two topical beta-adrenergic blocking agents is not recommended.
When patients have been switched from therapy with Timoptic in Ocudose ophthalmic solution administered twice daily to Timoptic in Ocudose Ophthalmic Gel Forming Solution administered once daily, the ocular hypotensive effect has remained consistent.
Timoptic in Ocudose interactions
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What other drugs will affect Timoptic in Ocudose?
Although TIMOPTIC (Timoptic in Ocudose ophthalmic solution) used alone has little or no effect on pupil size, mydriasis resulting from concomitant therapy with TIMOPTIC (Timoptic in Ocudose ophthalmic solution) and epinephrine has been reported occasionally.
Beta-adrenergic blocking agents: Patients who are receiving a beta-adrenergic blocking agent orally and Preservative-free TIMOPTIC in OCUDOSE should be observed for potential additive effects of beta-blockade, both systemic and on intraocular pressure. The concomitant use of two topical beta-adrenergic blocking agents is not recommended.
Calcium antagonists: Caution should be used in the coadministration of beta-adrenergic blocking agents, such as Preservative-free TIMOPTIC in OCUDOSE, and oral or intravenous calcium antagonists, because of possible atrioventricular conduction disturbances, left ventricular failure, and hypotension. In patients with impaired cardiac function, coadministration should be avoided.
Catecholamine-depleting drugs: 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 result in vertigo, syncope, or postural hypotension.
Digitalis and calcium antagonists: The concomitant use of beta-adrenergic blocking agents with digitalis and calcium antagonists may have additive effects in prolonging atrioventricular conduction time.
CYP2D6 inhibitors: Potentiated systemic beta-blockade (e.g., decreased heart rate, depression) has been reported during combined treatment with CYP2D6 inhibitors (e.g., quinidine, SSRIs) and Timoptic in Ocudose.
Clonidine:
Oral beta-adrenergic blocking agents may exacerbate the rebound hypertension which can follow the withdrawal of clonidine. There have been no reports of exacerbation of rebound hypertension with ophthalmic Timoptic in Ocudose. Injectable epinephrine:
Timoptic in Ocudose side effects
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What are the possible side effects of Timoptic in Ocudose?
Timoptic in Ocudose 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 Timoptic in Ocudose and placebo in hypertensive patients, the following adverse reactions were reported spontaneously and considered to be causally related to Timoptic in Ocudose:
Timoptic in Ocudose (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 Timoptic in Ocudose, 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 Timoptic in Ocudose and placebo groups were:
Adverse Reaction* | Withdrawal† | |||
---|---|---|---|---|
Timoptic in Ocudose (n=945) % | Placebo (n=939) % | Timoptic in Ocudose (n=945) % | Placebo (n=939) % | |
| ||||
Asthenia or Fatigue | 5 | 1 | <1 | <1 |
Heart Rate < 40 beats/minute | 5 | <1 | 4 | <1 |
Cardiac Failure-Nonfatal | 8 | 7 | 3 | 2 |
Hypotension | 3 | 2 | 3 | 1 |
Pulmonary Edema-Nonfatal | 2 | <1 | <1 | <1 |
Claudication | 3 | 3 | 1 | <1 |
AV Block 2nd or 3rd Degree | <1 | <1 | <1 | <1 |
Sinoatrial Block | <1 | <1 | <1 | <1 |
Cold Hands and Feet | 8 | <1 | <1 | 0 |
Nausea or Digestive Disorders | 8 | 6 | 1 | <1 |
Dizziness | 6 | 4 | 1 | 0 |
Bronchial Obstruction | 2 | <1 | 1 | <1 |
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 Timoptic in Ocudose 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 Timoptic in Ocudose, but reported with other beta-adrenergic blocking agents, should be considered potential adverse effects of Timoptic in Ocudose. 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 Timoptic in Ocudose.
Clinical Laboratory Test Findings
Clinically important changes in standard laboratory parameters were rarely associated with the administration of Timoptic in Ocudose. 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.
Timoptic in Ocudose contraindications
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What is the most important information I should know about Timoptic in Ocudose?
Hypersensitivity to Timoptic in Ocudose or any component of the formulation; sinus bradycardia; heart block greater than first degree (except in patients with a functioning artificial pacemaker); cardiogenic shock; uncompensated cardiac failure; bronchospastic disease
Documentation of allergenic cross-reactivity for beta-blockers is limited. However, because of similarities in chemical structure and/or pharmacologic actions, the possibility of cross-sensitivity cannot be ruled out with certainty.
Canadian labeling: Additional contraindications (not in US labeling): Right ventricular failure secondary to pulmonary hypertension; significant cardiomegaly; allergic rhinitis; severe chronic obstructive pulmonary disease; anesthesia with agents that produce myocardial depression (eg, ether hypersensitivity to Timoptic in Ocudose)
Active ingredient matches for Timoptic in Ocudose:
Unit description / dosage (Manufacturer) | Price, USD |
Solution; Ophthalmic; Timolol Maleate 0.25% | |
Solution; Ophthalmic; Timolol Maleate 0.5% | |
List of Timoptic in Ocudose substitutes (brand and generic names): | |
Timoptic-XE 0,5% (Switzerland) | |
Timoptol (Australia, Belgium, Chile, Costa Rica, Czech Republic, Ecuador, El Salvador, Ethiopia, France, Guatemala, Honduras, Ireland, Italy, Japan, Luxembourg, Malaysia, Malta, Mexico, Netherlands, New Zealand, Nicaragua, Oman, Panama, Philippines, Portugal, Singapore, South Africa, Sri Lanka, Taiwan, Thailand, United Kingdom, Venezuela) | |
Solution; Ophthalmic; Timolol Maleate 0.25% (Santen Pharma) | |
Solution; Ophthalmic; Timolol Maleate 0.5% (Santen Pharma) | |
Timoptol 0.25 % x 5 mL (Santen Pharma) | |
Timoptol 0.5 % x 5 mL (Santen Pharma) | |
Timoptol -XE 0.25 % x 2.5 mL (Santen Pharma) | |
Timoptol -XE 0.5 % x 2.5 mL (Santen Pharma) | |
Timoptol 0.5 % x 5 mL x 1's (Santen Pharma) | $ 10.13 |
Timoptol 0.25 % x 5 mL x 1 Bottle (Santen Pharma) | |
Timoptol 0.5 % x 5 mL x 1 Bottle (Santen Pharma) | |
Timoptol ophth drops 0.5 % 5 mL x 1's (Santen Pharma) | |
Timoptol ophth soln 0.5 % 5 mL x 1's (Santen Pharma) | |
Timoptol (Merck Sharp & Dohme (China) | |
Timoptol 0.25% (France, Japan) | |
Timoptol 0.5% (Japan) | |
Timoptol 0.50% (France) | |
Timoptol LA 0.25% (United Kingdom) | |
Timoptol LA 0.5% (United Kingdom) | |
Timoptol LP | |
Solution; Ophthalmic; Timolol Maleate 0.25% | |
Solution; Ophthalmic; Timolol Maleate 0.5% | |
Timoptol LP 0.25% (France) | |
Timoptol LP 0.50% (France) | |
Timoptol MSD (Czech Republic) | |
Timoptol Unit Dose | |
Solution; Ophthalmic; Timolol Maleate 0.25% | |
Solution; Ophthalmic; Timolol Maleate 0.5% | |
Timoptol XE (Australia, Brazil, Chile, Costa Rica, El Salvador, Guatemala, Honduras, Italy, New Zealand, Nicaragua, Panama, Peru, Singapore) | |
Timoptol XE 0.25% (Japan) | |
Timoptol XE 0.5% (Japan) | |
Timoptol 添慕寧 (Hongkong) | |
Timoptol eye drops 0.5 % 5 mL x 1's (Santen) | |
Timoptol-LA | |
Solution; Ophthalmic; Timolol Maleate 0.25% | |
Solution; Ophthalmic; Timolol Maleate 0.5% | |
Timoptol-XE (Philippines) | |
Solution; Ophthalmic; Timolol Maleate 0.25% (Santen) | |
Solution; Ophthalmic; Timolol Maleate 0.5% (Santen) | |
Timoptol-XE 0.5 % x 2.5 mL x 1's (Santen) | $ 9.28 |
Timoptol-XE 0.5 % x 2.5 mL (Santen) | |
Timoptol-XE ophth soln 0.5 % 2.5 mL x 1's (Santen) | |
Timoptol-XE ophth drops 0.5 % 2.5 mL x 1's (Santen) | |
Timoptolgel (Belgium, Luxembourg) | |
Timorite | |
Timorite Eye 5 ml Drop (Klar Sehen Pvt. Limited) | $ 0.11 |
TIMORITE 0.5% EYE DROPS 1 packet / 5 ML eye drop each (Klar Sehen Pvt. Limited) | $ 0.66 |
Timorite 0.5% Eye Drop (Klar Sehen Pvt. Limited) | $ 0.73 |
Timorite DPS (India) | |
Timorite DPS Hydroxypropylmethylcellulose 3mg, timolol maleate 5 mg, stabilized oxychloro complex0.05 mg/1 mL. EYE DPS / 5ml (Klar Sehen) | $ 0.51 |
See 1014 substitutes for Timoptic in Ocudose |
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).
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Information checked by Dr. Sachin Kumar, MD Pharmacology