Propranolol Hydrochloride And Hydrochlorothiazide
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Questions & Answers
Side Effects & Adverse Reactions
Propranolol Hydrochloride: Cardiac Failure: Sympathetic stimulation is a vital component supporting circulatory function in congestive heart failure, and inhibition with beta blockade always carries the potential hazard of further depressing myocardial contractility and precipitating cardiac failure. Propranolol acts selectively without abolishing the inotropic action of digitalis on the heart muscle (i.e., that of supporting the strength of myocardial contractions). In patients already receiving digitalis, the positive inotropic action of digitalis may be reduced by propranolol’s negative inotropic effect. The effects of propranolol and digitalis are additive in depressing AV conduction.
Patients Without a History of Heart Failure: Continued depression of the myocardium over a period of time can, in some cases, lead to cardiac failure. In rare instances, this has been observed during propranolol therapy. Therefore, at the first sign or symptom of impending cardiac failure, patients should be fully digitalized and/or given additional diuretic, and the response observed closely: a) if cardiac failure continues, despite adequate digitalization and diuretic therapy, propranolol therapy should be withdrawn (gradually, if possible); b) if tachyarrhythmia is being controlled, patients should be maintained on combined therapy and the patient closely followed until threat of cardiac failure is over.
Angina Pectoris: There have been reports of exacerbation of angina and, in some cases, myocardial infarction following abrupt discontinuation of propranolol therapy. Therefore, when discontinuance of propranolol is planned, the dosage should be gradually reduced and the patient should be carefully monitored. In addition, when propranolol is prescribed for angina pectoris, the patient should be cautioned against interruption or cessation of therapy without the physician’s advice. If propranolol therapy is interrupted and exacerbation of angina occurs, it usually is advisable to reinstitute propranolol therapy and take other measures appropriate for the management of unstable angina pectoris. Since coronary artery disease may be unrecognized, it may be prudent to follow the above advice in patients considered at risk of having occult atherosclerotic heart disease, who are given propranolol for other indications.
Nonallergic Bronchospasm (e.g., chronic bronchitis, emphysema): PATIENTS WITH BRONCHOSPASTIC DISEASES SHOULD, IN GENERAL, NOT RECEIVE BETA BLOCKERS. Propranolol should be administered with caution since it may block bronchodilation produced by endogenous and exogenous catecholamine stimulation of beta receptors.
Major Surgery:The necessity or desirability of withdrawal of beta-blocking therapy prior to major surgery is controversial. It should be noted, however, that the impaired ability of the heart to respond to reflex adrenergic stimuli may augment the risks of general anesthesia and surgical procedures.
Propranolol, like other beta blockers, is a competitive inhibitor of beta-receptor agonists, and its effects can be reversed by administration of such agents; e.g., dobutamine or isoproterenol. However, such patients may be subject to protracted severe hypotension. Difficulty in starting and maintaining the heartbeat has also been reported with beta blockers.
Diabetes and Hypoglycemia:Beta-adrenergic blockade may prevent the appearance of certain premonitory signs and symptoms (pulse rate and pressure changes) of acute hypoglycemia in labile insulin-dependent diabetes. In these patients, it may be more difficult to adjust the dosage of insulin. Hypoglycemic attack may be accompanied by a precipitous elevation of blood pressure in patients on propranolol.
Propranolol therapy, particularly in infants and children, diabetic or not, has been associated with hypoglycemia especially during fasting as in preparation for surgery. Hypoglycemia also has been found after this type of drug therapy and prolonged physical exertion and has occurred in renal insufficiency, both during dialysis, and sporadically, in patients on propranolol.
Acute increases in blood pressure have occurred after insulin-induced hypoglycemia in patients on propranolol.
Thyrotoxicosis:Beta blockade may mask certain clinical signs of hyperthyroidism. Therefore, abrupt withdrawal of propranolol may be followed by an exacerbation of symptoms of hyperthyroidism, including thyroid storm. Propranolol may change thyroid-function tests, increasing T4, and reverse T3, and decreasing T3.
Wolff-Parkinson-White Syndrome:Several cases have been reported in which, after propranolol, the tachycardia was replaced by a severe bradycardia requiring a demand pacemaker. In one case this resulted after an initial dose of 5 mg propranolol.
Hydrochlorothiazide: Thiazides should be used with caution in severe renal disease. In patients with renal disease, thiazides may precipitate azotemia. In patients with impaired renal function, cumulative effects of the drug may develop.
Thiazides should also be used with caution in patients with impaired hepatic function or progressive liver disease, since minor alterations of fluid and electrolyte balance may precipitate hepatic coma.
Thiazides may add to or potentiate the action of other antihypertensive drugs. Potentiation occurs with ganglionic or peripheral adrenergic-blocking drugs.
Sensitivity reactions may occur in patients with a history of allergy or bronchial asthma. The possibility of exacerbation or activation of systemic lupus erythematosus has been reported.
Legal Issues
There is currently no legal information available for this drug.
FDA Safety Alerts
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Manufacturer Warnings
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FDA Labeling Changes
There are currently no FDA labeling changes available for this drug.
Uses
Propranolol hydrochloride and hydrochlorothiazide tablets are indicated in the management of hypertension. This fixed combination is not indicated for initial therapy of hypertension. Hypertension requires therapy titrated to the individual patient. If the fixed combination represents the dosage so determined, its use may be more convenient in patient management.
History
There is currently no drug history available for this drug.
Other Information
Propranolol hydrochloride and hydrochlorothiazide tablets for oral administration combine two antihypertensive agents: propranolol hydrochloride, a beta-adrenergic blocking agent, and hydrochlorothiazide, a thiazide diuretic-antihypertensive.
Propranolol hydrochloride and hydrochlorothiazide tablets are available in 40 mg/25 mg and 80 mg/25 mg strengths. The 40 mg/25 mg tablets contain 40 mg propranolol hydrochloride and 25 mg hydrochlorothiazide; the 80 mg/25 mg tablets contain 80 mg propranolol hydrochloride and 25 mg hydrochlorothiazide.
Propranolol hydrochloride is a stable, white to off-white crystalline powder which is soluble in water and in alcohol. Its molecular weight is 295.81. Propranolol hydrochloride is a synthetic beta-adrenergic receptorblocking agent chemically described as 1-(Isopropylamino)-3 -(1- naphthyloxy)-2-propanol hydrochloride, which may be represented by the following structural formula:
Hydrochlorothiazide is a white, or practically white, practically odorless, crystalline powder. It is slightly soluble in water; freely soluble in sodium hydroxide solution; sparingly soluble in methanol; insoluble in ether, chloroform, benzene, and dilute mineral acids. Its chemical name is 6-Chloro-3,4-dihydro-2H-1,2,4-benzothiadiazine-7- sulfonamide 1,1-dioxide, which may be represented by the following structural formula:
The following inactive ingredients are contained in propranolol hydrochloride and hydrochlorothiazide tablets: Colloidal Silicon Dioxide, Corn Starch, Lactose Monohydrate and Magnesium Stearate.
Sources
Propranolol Hydrochloride And Hydrochlorothiazide Manufacturers
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Actavis Elizabeth Llc
![Propranolol Hydrochloride And Hydrochlorothiazide (Propranolol Hydrochloride And Hydrochlorothiazide) Tablet [Actavis Elizabeth Llc]](/wp-content/themes/bootstrap/assets/img/loading2.gif)
Propranolol Hydrochloride And Hydrochlorothiazide | Actavis Elizabeth Llc
The dosage must be determined by individual titration.
Hydrochlorothiazide can be given at doses of 12.5 to 50 mg per day when used alone. The initial dose of propranolol is 80 mg daily, and it may be increased gradually until optimal blood pressure control is achieved. The usual effective dose when used alone is 160 to 480 mg per day.
One propranolol hydrochloride and hydrochlorothiazide tablet twice daily can be used to administer up to 160 mg of propranolol and 50 mg of hydrochlorothiazide. For doses of propranolol greater than 160 mg the combination products are not appropriate, because their use would lead to an excessive dose of the thiazide component.
When necessary, another antihypertensive agent may be added gradually beginning with 50 percent of the usual recommended starting dose to avoid an excessive fall in blood pressure.
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Mylan Pharmaceuticals Inc.
Propranolol Hydrochloride And Hydrochlorothiazide | Apotheca Company
Directions: 10 drops orally, 3 times a day. Consult a physician for use in children under 12 years of age.
![Propranolol Hydrochloride And Hydrochlorothiazide Tablet [Mylan Pharmaceuticals Inc.]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=cb322536-1ae8-4d95-9682-490cc2924701&name=mm1.jpg)
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