What are the possible side effects of Timolol 0.25% Wockhardt?
Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.
Call your doctor at once if you have any of these serious side effects:
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slow or uneven heartbeats;
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feeling light-headed, fainting;
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feeling short of breath, even with mild exertion;
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swelling of your ankles or feet;
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nausea, stomach pain, low fever, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes);
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depression; or
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cold feeling in your hands and feet.
Other less serious side effects are more likely to occur, such as:
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decreased sex drive, impotence, or difficulty having an orgasm;
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sleep problems (insomnia);
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tired feeling; or
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anxiety, nervousness.
Side effects other than those listed here may also occur. Talk to your doctor about any side effect that seems unusual or that is especially bothersome. You may report side effects to FDA at 1-800-FDA-1088.
Side effects of Timolol 0.25% Wockhardt in details
Timolol 0.25% Wockhardt (Timolol 0.25% Wockhardt) 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 0.25% Wockhardt maleate and placebo in hypertensive patients, the following adverse reactions were reported spontaneously and considered to be causally related to Timolol 0.25% Wockhardt maleate:
Timolol 0.25% Wockhardt 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 Timolol 0.25% Wockhardt (Timolol 0.25% Wockhardt), 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 0.25% Wockhardt 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 Timolol 0.25% Wockhardt 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 0.25% Wockhardt (Timolol 0.25% Wockhardt), but reported with other beta-adrenergic blocking agents, should be considered potential adverse effects of Timolol 0.25% Wockhardt (Timolol 0.25% Wockhardt) : 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 0.25% Wockhardt (Timolol 0.25% Wockhardt).
Clinical Laboratory Test Findings: Clinically important changes in standard laboratory parameters were rarely associated with the administration of Timolol 0.25% Wockhardt (Timolol 0.25% Wockhardt). 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 Timolol 0.25% Wockhardt?
- Timolol 0.25% Wockhardt drops may cause drowsiness, dizziness, or blurred vision. These effects may be worse if you take it with alcohol or certain medicines. Use Timolol 0.25% Wockhardt drops with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.
- Tell your doctor or dentist that you take Timolol 0.25% Wockhardt drops before you receive any medical or dental care, emergency care, or surgery.
- Contact your doctor if you have an eye injury or infection, or if you will be having eye surgery.
- Diabetes patients - Timolol 0.25% Wockhardt drops may hide signs of low blood sugar, such as a rapid heartbeat. Be sure to watch for other signs of low blood sugar. Low blood sugar may make you anxious, sweaty, weak, dizzy, drowsy, or faint. It may also make your vision change; give you a headache, chills, or tremors; or make you more hungry. Check blood sugar levels closely. Ask your doctor before you change the dose of your diabetes medicine.
- If you have a history of any severe allergic reaction, talk with your doctor. You may be at risk for an even more severe allergic reaction if you come into contact with the substance that caused your allergy. Some medicines used to treat severe allergies may also not work as well while you are using Timolol 0.25% Wockhardt drops.
- Timolol 0.25% Wockhardt drops may cause harm if it is swallowed. If you may have taken it by mouth, contact your or emergency room right away.
- Lab tests, including eye pressure, may be performed while you use Timolol 0.25% Wockhardt drops. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.
- Timolol 0.25% Wockhardt drops should be used with extreme caution in CHILDREN; safety and effectiveness in children have not been confirmed.
- PREGNANCY and BREAST-FEEDING: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Timolol 0.25% Wockhardt drops while you are pregnant. Timolol 0.25% Wockhardt drops is found in breast milk. Do not breast-feed while taking Timolol 0.25% Wockhardt drops.
Timolol 0.25% Wockhardt contraindications
Do not stop taking Timolol 0.25% Wockhardt 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 0.25% Wockhardt. Be sure the surgeon knows ahead of time that you are using Timolol 0.25% Wockhardt.
Timolol 0.25% Wockhardt 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 0.25% Wockhardt.
Timolol 0.25% Wockhardt 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.
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).
- European Chemicals Agency - ECHA. "(S)-1-(tert-butylamino)-3-[(4-morpholino-1,2,5-thiadiazol-3-yl)oxy]propan-2-ol: The information provided here is aggregated from the "Notified classification and labelling" from ECHA's C&L Inventory. ". https://echa.europa.eu/information-o... (accessed September 17, 2018).
- HSDB. "TIMOLOL". https://toxnet.nlm.nih.gov/cgi-bin/s... (accessed September 17, 2018).
Reviews
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Information checked by Dr. Sachin Kumar, MD Pharmacology