Timolide

Name: Timolide

US Brand Name

  1. Timolide

Descriptions

Timolol and hydrochlorothiazide combination is used 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 .

Timolol is a beta-blocker. It works by affecting the response to some 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 .

Hydrochlorothiazide is a diuretic (water pill). It reduces the amount of water in the body by increasing the flow of urine, which helps lower the blood pressure .

This medicine is available only with your doctor's prescription .

This product is available in the following dosage forms:

  • Tablet

Indications

TIMOLIDE (timolol maleate-hydrochlorothiazide) is indicated for the treatment of hypertension.

This fixed combination drug is not indicated for initial therapy of hypertension. If the fixed combination represents the dose titrated to an individual patient†s needs, it may be more convenient than the separate components.

How supplied

No. 3373 _ Tablets TIMOLIDE (timolol maleate-hydrochlorothiazide) 10-25 are light blue, flat, hexagonal-shaped, compressed tablets, with code MSD 67 on one side and TIMOLIDE (timolol maleate-hydrochlorothiazide) on the other. Each tablet contains 10 mg of timolol maleate and 25 mg of hydrochlorothiazide. They are supplied as follows: NDC 0006-0067-68 bottles of 100.

Storage

Store at controlled room temperature, 15-30°C (59-86°F). Keep container tightly closed. Protect from light.

Whitehouse Station, NJ 08889, USA

Issued October 2003

Side effects

TIMOLIDE (timolol maleate-hydrochlorothiazide) 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 (timolol maleate-hydrochlorothiazide) ).

Incidence Greater Than 1%

Incidence Less Than 1%

BODY AS A WHOLE

 

fatigue/tiredness (1.9%)

chest pain

asthenia (1.9%)

headache

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, pares-thesias, restlessness; Hematologic: leukopenia, agranu-locytosis, 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, hyperuri-cemia, 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 performances 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 (timolol maleate-hydrochlorothiazide) or BLOCADREN* (timolol maleate).

Clinical Laboratory Test Findings: Clinically important changes in standard laboratory parameters were rarely associated with the administration of TIMOLIDE (timolol maleate-hydrochlorothiazide) . 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.

Other Medical Problems

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

  • Angina (severe chest pain)—May provoke chest pain if stopped too quickly .
  • Anuria (not able to form urine) or
  • Asthma or
  • Bradycardia (slow heartbeat) or
  • Chronic obstructive pulmonary disease (COPD), severe or
  • Heart block or
  • Heart failure—Should not use in patients with these conditions .
  • Blood vessel disease (especially blood vessels in the brain) or
  • Gout or
  • High cholesterol or
  • Hyperuricemia (high uric acid in the blood) or
  • Hypochloremia (low chloride in the blood) or
  • Hypokalemia (low potassium in the blood) or
  • Hypomagnesemia (low magnesium in the blood) or
  • Hyponatremia (low sodium in the blood) or
  • Parathyroid disease or
  • Stroke, history of or
  • Systemic lupus erythematosus—Use with caution. This medicine may make these conditions worse .
  • Diabetes or
  • Hyperthyroidism (overactive thyroid) or
  • Hypoglycemia (low blood sugar)—May cover up some of the signs and symptoms of these diseases, such as a fast heartbeat .
  • Kidney disease, severe or
  • Liver disease—Use with caution. The effects may be increased because of slower removal of the medicine from the body .
  • Lung disease (e.g. bronchitis, emphysema)—May cause difficulty with breathing in patients with this condition .
  • Myasthenia gravis—May worsen symptoms of this condition, such as muscle weakness .
  • Sympathectomy—Use with caution. The effects of this medicine may be increased .

Dosing

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

  • For oral dosage form (tablets):
    • For high blood pressure:
      • Adults—One tablet two times a day, or two tablets once a day. Your doctor may adjust your dose if needed.
      • Children—Use and dose must be determined by your doctor .

Uses For Timolide

Timolol and hydrochlorothiazide combination is used 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 .

Timolol is a beta-blocker. It works by affecting the response to some 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 .

Hydrochlorothiazide is a diuretic (water pill). It reduces the amount of water in the body by increasing the flow of urine, which helps lower the blood pressure .

This medicine is available only with your doctor's prescription .

Hydrochlorothiazide / timolol Breastfeeding Warnings

Hydrochlorothiazide and timolol are excreted into human milk. No adverse reactions in nursing infants have been reported, but close observation for bradycardia and other signs of beta-blockade in infants exposed to timolol via breast milk is recommended. Timolol is considered compatible with breast-feeding by the American Academy of Pediatrics. Hydrochlorothiazide is considered compatible with breast-feeding by the American Academy of Pediatrics; however, the manufacturer recommends that due to the potential for serious adverse reactions in nursing infants, a decision should be made to discontinue nursing or discontinue the drug, taking into account the importance of the drug to the mother.

Data reveal average milk to maternal plasma timolol level ratios of 0.80 to 0.83. In one series of nine patients, dosages of timolol of 5 mg three times a day were associated with an average milk timolol level of 15.9 ng/mL. After the dosage was increased to 10 mg three times a day in four of the nine patients, the average milk timolol level rose to 41.0 ng/mL. A case report of a human milk timolol concentration of 5.6 ng/mL 1.5 hours after dosing has been reported in a woman who was receiving timolol 0.5% eye drops to the right eye twice daily. In this case, even if the infant nursed 4 times daily, receiving 75 mL each time, the daily dose to the nursing infant would be below that expected to produce beta-blockade. A peak milk HCTZ level of 125 ng/mL was measured between 4 and 12 hours after a dose in a woman who was taking HCTZ 50 mg/day. A simultaneously measured maternal serum HCTZ level was approximately 275 ng/mL. There were no detectable drug levels or electrolyte abnormalities in the baby's blood. The authors calculated that, if a 1-month-old infant takes approximately 600 mL of milk per day, and the mean milk HCTZ level is approximately 80 ng/mL, the infant would be exposed to approximately 0.05 mg HCTZ daily. This should represent an insignificant amount of HCTZ to the infant such that adverse effects in the nursing infant are unlikely.

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