Timodrop 0.5%, 1 bottle x 5 ml
Generic Name: Timelel
What is Timodrop?
Timodrop 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.
Timodrop 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.
Timodrop 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.
Timodrop is available only with your doctor’s prescription.
Timodrop (Timodrop) is indicated for the treatment of hypertension. It may be used alone or in combination with other antihypertensive agents, especially thiazide-type diuretics.
Timodrop (Timodrop) 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.
Timodrop (Timodrop) is indicated for the prophylaxis of migraine headache.
How should I use Timodrop?
Use Timodrop drops as directed by your doctor. Check the label on the medicine for exact dosing instructions.
- An extra patient leaflet is available with Timodrop drops. Talk to your pharmacist if you have questions about this information.
- Timodrop 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 Timodrop drops. Remove contact lenses before you use Timodrop drops; lenses may be placed back in the eyes 15 minutes after use of Timodrop drops.
- To use Timodrop 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 Timodrop drops at least 10 minutes before or after any other medicine that you put in your eye.
- Using Timodrop drops at the same time each day will help you remember to use it.
- Continue to use Timodrop drops even if you feel well. Do not miss any doses.
- If you miss a dose of Timodrop 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 Timodrop drops.
Uses of Timodrop in details
Timodrop is used to treat high blood pressure, stabilize irregular heartbeats (arrhythmias), prevent angina (heart pain) and improve survival chances post heart attack. It is also used to treat glaucoma, a condition wherein there is an increased pressure in the eye and this may lead to blindness. It is also used to treat headaches due to migraine.
Each mL of Timodrop 0.5% contains 5 mg of Timodrop (6.8 mg of Timodrop). 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 Timodrop contains the previously mentioned active and inactive ingredients except for the preservative benzododecinium bromide.
Timodrop 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). Timodrop possesses an asymmetric carbon atom and is provided as the levo isomer. The empirical formula is C13H24N403S·C4H404.
Timodrop 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 Timodrop (Timodrop) 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.
Timodrop (Timodrop) 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 Timodrop (Timodrop) 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 Timodrop (Timodrop) should be discontinued.
No. 3343 — Tablets Timodrop (Timodrop), 5 mg, are light blue, round, compressed tablets, with code MSD 59 on one side and Timodrop (Timodrop) on the other. They are supplied as follows:
NDC 0006-0059-68 bottles of 100.
No. 3344 — Tablets Timodrop (Timodrop), 10 mg, are light blue, round, scored, compressed tablets, with code MSD 136 on one side and Timodrop (Timodrop) on the other. They are supplied as follows:
NDC 0006-0136-68 bottles of 100
No. 3371 — Tablets Timodrop (Timodrop), 20 mg, are light blue, capsule shaped, scored, compressed tablets, with code MSD 437 on one side and Timodrop (Timodrop) 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
What other drugs will affect Timodrop?
Beta-adrenergic blocking agents: Patients who are receiving a beta-adrenergic blocking agent orally and Nu-Timodrop 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-Timodrop 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 Timodrop or other ORAL beta-blocking agents and may be considered potential effects of ophthalmic Timodrop: 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.
Timodrop side effects
What are the possible side effects of Timodrop?
Timodrop (Timodrop) is usually well tolerated in properly selected patients. Most adverse effects have been mild and transient.
In a multicenter (12-week) clinical trial comparing Timodrop and placebo in hypertensive patients, the following adverse reactions were reported spontaneously and considered to be causally related to Timodrop:
These data are representative of the incidence of adverse effects that may be observed in properly selected patients treated with Timodrop (Timodrop), 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 Timodrop 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 Timodrop 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 Timodrop (Timodrop), but reported with other beta-adrenergic blocking agents, should be considered potential adverse effects of Timodrop (Timodrop) : 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 Timodrop (Timodrop).
Clinical Laboratory Test Findings: Clinically important changes in standard laboratory parameters were rarely associated with the administration of Timodrop (Timodrop). 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.
What is the most important information I should know about Timodrop?
Do not stop taking Timodrop 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 Timodrop. Be sure the surgeon knows ahead of time that you are using Timodrop.
Timodrop 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 Timodrop.
Timodrop 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.