DrugLib.com — Drug Information Portal

Rx drug information, pharmaceutical research, clinical trials, news, and more

Timolide (Timolol Maleate / Hydrochlorothiazide) - Side Effects and Adverse Reactions

 
 



ADVERSE REACTIONS

TIMOLIDE is usually well tolerated in properly selected patients. Most adverse effects have been mild and transient.

The adverse reactions listed in the following table were spontaneously reported and have been arranged into two groups: (1) incidence greater than 1%; and (2) incidence less than 1%. The incidence was obtained from clinical studies conducted in the United States (257 patients treated with TIMOLIDE).

Incidence Greater
Than 1%
Incidence Less
Than 1%
BODY AS A WHOLE
fatigue/tiredness
(1.9%)
chest pain
headache
asthenia (1.9%)
CARDIOVASCULAR
hypotension (1.6%) arrhythmia
bradycardia (1.2%) syncope
cardiac failure
DIGESTIVE SYSTEM
none diarrhea
dyspepsia
nausea
gastrointestinal pain
constipation
INTEGUMENTARY
none rash
increased pigmentation
dry mucous membranes
MUSCULOSKELETAL
none myalgia
NERVOUS SYSTEM
dizziness (1.2%) none
PSYCHIATRIC
none insomnia
decreased libido
nervousness
confusion
trouble concentrating
somnolence
RESPIRATORY
bronchial spasm
(1.6%)
rales
dyspnea (1.2%)
UROGENITAL
none renal colic

The following additional adverse effects have been reported in clinical experience with the drug: cerebral ischemia, cerebral vascular accident, gout, muscle cramps, oculogyric crisis, worsening of chronic obstructive pulmonary disease, earache, and impotence.

Other adverse reactions that have been reported with the individual components are listed below:

Timolol Maleate --Body as a Whole: extremity pain, decreased exercise tolerance, weight loss, fever; Cardiovascular: cardiac arrest, cerebral vascular accident, worsening of angina pectoris, sinoatrial block, AV block, worsening of arterial insufficiency, Raynaud's phenomenon, claudication, palpitations, vasodilatation, cold hands and feet, edema; Digestive: hepatomegaly, elevated liver function tests, vomiting; Hematologic: nonthrombocytopenic purpura; Endocrine: hyperglycemia, hypoglycemia; Skin: skin irritation, pruritus, sweating, alopecia; Musculoskeletal: arthralgia; Nervous System: local weakness, vertigo, paresthesia, increase in signs and symptoms of myasthenia gravis; Psychiatric: depression, nightmares, hallucinations; Respiratory: cough; Special Senses: visual disturbances, diplopia, ptosis, eye irritation, dry eyes, tinnitus; Urogenital: urination difficulties.

There have been reports of retroperitoneal fibrosis in patients receiving timolol 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.

Hydrochlorothiazide --Body as a Whole: weakness; Digestive: anorexia, gastric irritation, vomiting, cramping, jaundice (intrahepatic cholestatic jaundice), pancreatitis, sialadenitis; Nervous System/Psychiatric: vertigo, paresthesias, restlessness; Hematologic: leukopenia, agranulocytosis, thrombocytopenia, aplastic anemia, hemolytic anemia; Cardiovascular: hypotension including orthostatic hypotension (may be aggravated by alcohol, barbiturates, narcotics or antihypertensive drugs); Hypersensitivity: purpura, photosensitivity, urticaria, necrotizing angiitis (vasculitis, cutaneous vasculitis), fever, respiratory distress including pneumonitis and pulmonary edema, anaphylactic reactions; Metabolic: hyperglycemia, glycosuria, hyperuricemia, electrolyte imbalance (see PRECAUTIONS); Musculoskeletal: muscle spasm; Renal: renal failure, renal dysfunction, interstitial nephritis (See WARNINGS); Skin: erythema multiforme including Stevens-Johnson syndrome, exfoliative dermatitis including toxic epidermal necrolysis, alopecia; Special Senses: transient blurred vision, xanthopsia.

Potential Adverse Effects: In addition, a variety of adverse effects not observed in clinical trials with timolol maleate, but reported with other beta-adrenergic blocking agents, should be considered potential adverse effects of timolol maleate: 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 (see CONTRAINDICATIONS); 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 TIMOLIDE or BLOCADREN * (timolol maleate).

Clinical Laboratory Test Findings: Clinically important changes in standard laboratory parameters were rarely associated with the administration of TIMOLIDE. The changes in laboratory parameters were not progressive and usually were not associated with clinical manifestations. The most common changes were increases in serum triglycerides and uric acid and decreases in serum potassium and chloride. Decreases in HDL cholesterol have been reported.


*Registered trademark of MERCK & CO., INC.

Drug label data at the top of this Page last updated: 2006-06-06

-- advertisement -- The American Red Cross
 
Home | About Us | Contact Us | Site usage policy | Privacy policy

All Rights reserved - Copyright DrugLib.com, 2006-2017