DRUGS & SUPPLEMENTS

Propranolol; Hydrochlorothiazide

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Propranolol; Hydrochlorothiazide uses

Propranolol; Hydrochlorothiazide consists of Hydrochlorothiazide, Propranolol Hydrochloride.

Hydrochlorothiazide:


Propranolol; Hydrochlorothiazide information

Propranolol; Hydrochlorothiazide (Hydrochlorothiazide) is an antihypertensive, diuretic drug that acts on the electrolyte reabsorption in the renal tubular mechanism increasing the excretion of chloride and sodium in equivalent amounts. The exact mechanism of its antihypertensive action is not known at this time.

Propranolol; Hydrochlorothiazide indications

Propranolol; Hydrochlorothiazide (Hydrochlorothiazide) is typically employed for the treatment of patients suffering from hypertension, either as monotherapy or in combination with other antihypertensive medication. It is also employed in some cases as a diuretic agent. Propranolol; Hydrochlorothiazide (Hydrochlorothiazide) therapy may also be prescribed for the treatment of hepatic cirrhosis, edema (in patients suffering from congestive heart failure), nephrotic syndrome, drug induced edema, chronic renal failure or acute glomerulonephritis. Health care professionals may prescribe this drug in order to treat other medical conditions as well; if you would like to know more about the reasons you have been prescribed this drug, it is advised to ask your personal physician.

Propranolol; Hydrochlorothiazide warnings

Propranolol; Hydrochlorothiazide (Hydrochlorothiazide) may not be used in the treatment of patients who are allergic to this drug, any of its components or other sulfonamide-derived medication. Also, this drug may not be suitable for use in patients that are suffering from anuria, azotemia or impaired renal functions. Caution should be employed if the patient is suffering from hepatic disease. Other medical conditions may also influence the examining health care provider's decision of prescribing Propranolol; Hydrochlorothiazide (Hydrochlorothiazide); it is strongly recommended to make sure that the health care professional is fully aware of your health condition and medical history before starting a treatment with this drug.

Use of Propranolol; Hydrochlorothiazide (Hydrochlorothiazide) during pregnancy or breast-feeding is also not recommended. This medicine may affect an unborn baby and it also passes into breast milk. As such, use of this drug in pregnant women or breast-feeding mothers should not be employed.

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Propranolol; Hydrochlorothiazide intake guidelines

You should always take Propranolol; Hydrochlorothiazide (Hydrochlorothiazide) as you have been directed by the prescribing health care specialist. While in some cases daily administration of the drug is recommended, other patients may be prescribed an intermittent therapy. Also, the number of daily doses may vary. As such, it is best that you do not follow another patient's intake schedule. If you have difficulties understanding the intake guidelines that your prescribing health care professional has provided, you should ask for further explanations from an authorized health care specialist - such as a pharmacist, a doctor or a nurse.

Propranolol; Hydrochlorothiazide dosage

The exact Propranolol; Hydrochlorothiazide (Hydrochlorothiazide) dosage may vary greatly from one case to another, depending on the condition being treated, on the patient's medical history and general health condition, on his or her age as well as on a number of other factors. As such you are advised to use the exact Propranolol; Hydrochlorothiazide (Hydrochlorothiazide) dosage that has been prescribed to you and never use the dosage prescribed to another patient or a dosage that you have been prescribed in the past. Taking a different Propranolol; Hydrochlorothiazide (Hydrochlorothiazide) dose may cause the treatment to not have the desired effect, and if you take this drug in larger doses you may have a higher risk of developing side effects, or you may suffer from an overdose.

Propranolol; Hydrochlorothiazide overdose

You should never exceed the Propranolol; Hydrochlorothiazide (Hydrochlorothiazide) prescribed dosage, in order to avoid an overdose with this medication. However, if you consider that you are affected by an overdose with this drug it is advised to immediately consult your personal health care provider, the local poisons center or to go to the nearest medical facility to seek emergency medical attention. The common symptoms of an overdose with Propranolol; Hydrochlorothiazide (Hydrochlorothiazide) are dehydration and cardiac arrhythmia. The patient may also suffer from electrolyte depletion and thus may present the relevant signs and symptoms.

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Propranolol; Hydrochlorothiazide missed dose

In case you have missed a dose of Propranolol; Hydrochlorothiazide (Hydrochlorothiazide), it is advised that you take the dose as soon as you remember. If the moment when you remember is too close to another intake of the medication, you should completely skip the missed Propranolol; Hydrochlorothiazide (Hydrochlorothiazide) dose and take the next scheduled dose on time. You should never take a larger dose of the drug in order to make up for a missed dose, unless your prescribing health care provider directs you to do so.

Propranolol; Hydrochlorothiazide side effects

In some patients Propranolol; Hydrochlorothiazide (Hydrochlorothiazide) may cause side effects. While they are not very common, it is recommended to let your personal health care provider know if you begin experiencing any side effects. Several types of symptoms are possible: dizziness, headache, paresthesias, gastric irritation, anorexia, nausea and vomiting, diarrhea or constipation, pancreatitis, jaundice, hypotension. Metabolic side effects may include glycosuria, hyperglycemia, hyperuricemia, hypokalemia or hyponatremia. Renal failure or dysfunction may develop, as well as interstitial nephritis. Some patients reported experiencing muscle spasms, restlessness, unusual weakness and blurred vision. In some cases photosensitivity, anaphylactic reactions, respiratory distress, fever, rashes, vasculitis or toxic epidermal necrolysis have occurred.

Propranolol; Hydrochlorothiazide drug reactions

Propranolol; Hydrochlorothiazide (Hydrochlorothiazide) may interact with barbiturates and narcotics, as well as with alcohol. If you are also following a treatment course with antidiabetic drugs, their dosage may need to be adjusted before starting to take Propranolol; Hydrochlorothiazide (Hydrochlorothiazide). This drug may have an additive effect with other antihypertensive medication. ACE inhibitors, ACTH, corticosteroids and skeletal muscle relaxants may also interact with this drug causing unwanted effects. This drug may not be properly absorbed if the patient is also taking Colestipol resins or Cholestyramine. NSAIDs, lithium and Pressor amines may affect or be affected by Propranolol; Hydrochlorothiazide (Hydrochlorothiazide), and as such it is strongly recommended to let the prescribing health care provider know if you are taking these or any other drugs before starting a therapy course with this medicine. Other drug interactions that are not listed here are also possible.

Propranolol Hydrochloride:


DESCRIPTION

Propranolol; Hydrochlorothiazide (Propranolol Hydrochloride) Hydrochloride, USP is a synthetic beta-adrenergic receptor blocking agent chemically described as (+)-1-(isopropylamino)-3-(1-naphthyloxy)-2-propanol hydrochloride. Its structural formula is:

Propranolol; Hydrochlorothiazide (Propranolol Hydrochloride) Hydrochloride, USP is a stable, white, crystalline solid which is readily soluble in water and ethanol. Its molecular weight is 295.80.

Propranolol; Hydrochlorothiazide (Propranolol Hydrochloride) Hydrochloride Injection, USP is available as a sterile injectable solution for intravenous administration. Each mL contains 1 mg of Propranolol; Hydrochlorothiazide (Propranolol Hydrochloride) Hydrochloride, USP in Water for Injection, USP. The pH is adjusted with anhydrous Citric Acid, USP.

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CLINICAL PHARMACOLOGY

General

Propranolol; Hydrochlorothiazide (Propranolol Hydrochloride) is a nonselective beta-adrenergic receptor blocking agent possessing no other autonomic nervous system activity. It specifically competes with beta-adrenergic receptor stimulating agents for available receptor sites. When access to beta-recceptor sites is blocked by Propranolol; Hydrochlorothiazide (Propranolol Hydrochloride), chronotropic, inotropic, and vasodilator responses to beta-adrenergic stimulation are decreased proportionately. At doses greater than required for beta blockade, Propranolol; Hydrochlorothiazide (Propranolol Hydrochloride) also exerts a quinidine-like or anesthetic-like membrane action, which affects the cardiac action potential. The significance of the membrane action in the treatment of arrhythmias is uncertain.

Mechanism of Action

The effects of Propranolol; Hydrochlorothiazide (Propranolol Hydrochloride) are due to selective blockade of beta-adrenergic receptors, leaving alpha-adrenergic responses intact. There are two well-characterized subtypes of beta receptors (beta1 and beta2); Propranolol; Hydrochlorothiazide (Propranolol Hydrochloride) interacts with both subtypes equally. Beta1-adrenergic receptors leads to a decrease in the activity of both normal and ectopic pacemaker cells and a decrease in A-V nodal conduction velocity. All of these actions can contribute to antiarrhythmic activity and control of ventricular rate during arrhythmias. Blockade of cardiac beta1-adrenergic receptors also decreases the myocardial force of contraction and may provoke cardiac decompensation in patients with minimal cardiac reserve.

Beta2-adrenergic receptors are found predominantly in smooth muscle-vascular, bronchial, gastrointestinal and genitourinary. Blockade of these receptors results in constriction. Clinically, Propranolol; Hydrochlorothiazide (Propranolol Hydrochloride) may exacerbate respiratory symptoms in patients with obstructive pulmonary diseases such as asthma and emphysema.

Propranolol's beta blocking effects are attributable to its S(-) enantiomer.

Pharmacokinetics and Drug Metabolism

Distribution

Propranolol; Hydrochlorothiazide (Propranolol Hydrochloride) has a distribution half-life (T1/2 alpha) of 5-10 minutes and a volume of distribution of about 4 to 5 L/kg. Approximately 90% of circulating Propranolol; Hydrochlorothiazide (Propranolol Hydrochloride) is bound to plasma proteins. The binding is enantiomer-selective. The S-isomer is preferentially bound to alpha1 glycoprotein and the R-isomer is preferentially bound to albumin.

Metabolism and Elimination

The elimination half-life (T½ beta) is between 2 and 5.5 hours. Propranolol; Hydrochlorothiazide (Propranolol Hydrochloride) is extensively metabolized with most metabolites appearing in the urine. The major metabolites include Propranolol; Hydrochlorothiazide (Propranolol Hydrochloride) glucuronide, naphthyloxylactic acid, and glucuronic acid and sulfate conjugates of 4-hydroxy Propranolol; Hydrochlorothiazide (Propranolol Hydrochloride). Following single-dose intravenous administration, side-chain oxidative products account for approximately 40% of the metabolites, direct conjugation products account for approximately 45-50% of metabolites, and ring oxidative products account for approximately 10-15% of metabolites. Of these, only the primary ring oxidative product (4-hydroxypropranolol) possesses beta-adrenergic receptor blocking activity.

In vitro studies have indicated that the aromatic hydroxylation of Propranolol; Hydrochlorothiazide (Propranolol Hydrochloride) is catalyzed mainly by polymorphic CYP2D6. Side‑chain oxidation is mediated mainly by CYP1A2 and to some extent by CYP2D6. 4-hydroxy Propranolol; Hydrochlorothiazide (Propranolol Hydrochloride) is a weak inhibitor of CYP2D6.

Pharmacodynamics

As Propranolol; Hydrochlorothiazide (Propranolol Hydrochloride) concentration increases, so does its beta-blocking effect, as evidenced by a reduction in exercise-induced tachycardia (n = 6 normal volunteers).

Special Populations

Pediatric

The pharmacokinetics of Propranolol; Hydrochlorothiazide (Propranolol Hydrochloride) have not been investigated in patients under 18 years of age. Propranolol; Hydrochlorothiazide (Propranolol Hydrochloride) injection is not recommended for treatment of cardiac arrhythmias in pediatric patients.

Geriatric

Elevated Propranolol; Hydrochlorothiazide (Propranolol Hydrochloride) plasma concentrations, a longer mean elimination half-life (254 vs. 152 minutes), and decreased systemic clearance (8 vs. 13 mL/kg/min) have been observed in elderly subjects when compared to young subjects. However, the apparent volume of distribution seems to be similar in elderly and young subjects. These findings suggest that dose adjustment of Propranolol; Hydrochlorothiazide (Propranolol Hydrochloride) injection may be required for elderly patients.

Gender

Intravenously administered Propranolol; Hydrochlorothiazide (Propranolol Hydrochloride) was evaluated in 5 women and 6 men. When adjusted for weight, there were no gender-related differences in elimination half-life, volume of distribution, protein binding, or systemic clearance.

Obesity

In a study of intravenously administered Propranolol; Hydrochlorothiazide (Propranolol Hydrochloride), obese subjects had a higher AUC (161 versus 109 hr·mcg/L) and lower total clearance than did non-obese subjects. Propranolol; Hydrochlorothiazide (Propranolol Hydrochloride) plasma protein binding was similar in both groups.

Renal Insufficiency

The pharmacokinetics of Propranolol; Hydrochlorothiazide (Propranolol Hydrochloride) and its metabolites were evaluated in 15 subjects with varying degrees of renal function after Propranolol; Hydrochlorothiazide (Propranolol Hydrochloride) administration via the intravenous and oral routes. When compared with normal subjects, an increase in fecal excretion of Propranolol; Hydrochlorothiazide (Propranolol Hydrochloride) conjugates was observed in patients with increased renal impairment. Propranolol; Hydrochlorothiazide (Propranolol Hydrochloride) was also evaluated in 5 patients with chronic renal failure, 6 patients on regular dialysis, and 5 healthy subjects, following a single oral dose of 40 mg of Propranolol; Hydrochlorothiazide (Propranolol Hydrochloride). The peak plasma concentrations (Cmax) of Propranolol; Hydrochlorothiazide (Propranolol Hydrochloride) in the chronic renal failure group were 2- to 3-fold higher (161 ng/mL) than those observed in the dialysis patients (47 ng/‌mL) and in the healthy subjects (26 ng/mL). Propranolol; Hydrochlorothiazide (Propranolol Hydrochloride) plasma clearance was also reduced in the patients with chronic renal failure.

Chronic renal failure has been associated with a decrease in drug metabolism via downregulation of hepatic cytochrome P-450 activity.

Hepatic Insufficiency

Propranolol; Hydrochlorothiazide (Propranolol Hydrochloride) is extensively metabolized by the liver. In a study conducted in 6 normal subjects and 20 patients with chronic liver disease, including hepatic cirrhosis, 40 mg of R-propranolol was administered intravenously. Compared to normal subjects, patients with chronic liver disease had decreased clearance of Propranolol; Hydrochlorothiazide (Propranolol Hydrochloride), increased volume of distribution, decreased protein-binding, and considerable variation in half-life. Caution should be exercised when Propranolol; Hydrochlorothiazide (Propranolol Hydrochloride) is used in this population. Consideration should be given to lowering the dose of intravenous Propranolol; Hydrochlorothiazide (Propranolol Hydrochloride) in patients with hepatic insufficiency.

Thyroid Dysfunction

No pharmacokinetic changes were observed in hyperthyroid or hypothyroid patients when compared to their corresponding euthyroid state. Dosage adjustment does not seem necessary in either patient population based on pharmacokinetic findings.

Drug Interactions

Interactions with Substrates, Inhibitors or Inducers of Cytochrome P-450 Enzymes

Because propranolol’s metabolism involves multiple pathways in the cytochrome P-450 system (CYP2D6, 1A2, 2C19), administration of Propranolol; Hydrochlorothiazide (Propranolol Hydrochloride) with drugs that are metabolized by, or affect the activity (induction or inhibition) of one or more of these pathways may lead to clinically relevant drug interactions.

Substrates or Inhibitors of CYP2D6

Blood levels of Propranolol; Hydrochlorothiazide (Propranolol Hydrochloride) may be increased by administration of Propranolol; Hydrochlorothiazide (Propranolol Hydrochloride) with substrates or inhibitors of CYP2D6, such as amiodarone, cimetidine, delavirdine, fluoxetine, paroxetine, quinidine, and ritonavir. No interactions were observed with either ranitidine or lansoprazole.

Substrates or Inhibitors of CYP1A2

Blood levels of Propranolol; Hydrochlorothiazide (Propranolol Hydrochloride) may be increased by administration of Propranolol; Hydrochlorothiazide (Propranolol Hydrochloride) with substrates or inhibitors of CYP1A2, such as imipramine, cimetidine, ciprofloxacin, fluvoxamine, isoniazid, ritonavir, theophylline, zileuton, zolmitriptan, and rizatriptan.

Substrates or Inhibitors of CYP2C19

Blood levels of Propranolol; Hydrochlorothiazide (Propranolol Hydrochloride) may be increased by administration of Propranolol; Hydrochlorothiazide (Propranolol Hydrochloride) with substrates or inhibitors of CYP2C19, such as fluconazole, cimetidine, fluoxetine, fluvoxamine, teniposide, and tolbutamide. No interaction was observed with omeprazole.

Inducers of Hepatic Drug Metabolism

Blood levels of Propranolol; Hydrochlorothiazide (Propranolol Hydrochloride) may be decreased by administration of Propranolol; Hydrochlorothiazide (Propranolol Hydrochloride) with inducers such as rifampin and ethanol. Cigarette smoking also induces hepatic metabolism and has been shown to increase up to 100% the clearance of Propranolol; Hydrochlorothiazide (Propranolol Hydrochloride), resulting in decreased plasma concentrations.

Cardiovascular Drugs

Antiarrhythmics

The AUC of propafenone is increased by more than 200% with co-administration of Propranolol; Hydrochlorothiazide (Propranolol Hydrochloride).

The metabolism of Propranolol; Hydrochlorothiazide (Propranolol Hydrochloride) is reduced by co-administration of quinidine, leading to a 2- to 3-fold increased blood concentrations and greater beta-blockade.

The metabolism of lidocaine is inhibited by co-administration of Propranolol; Hydrochlorothiazide (Propranolol Hydrochloride), resulting in a 25% increase in lidocaine concentrations.

Calcium Channel Blockers

The mean Cmax and AUC of Propranolol; Hydrochlorothiazide (Propranolol Hydrochloride) are increased respectively, by 50% and 30% by co-administration of nisoldipine and by 80% and 47%, by co-administration of nicardipine.

The mean values of Cmax and AUC of nifedipine are increased by 64% and 79%, respectively, by co-administration of Propranolol; Hydrochlorothiazide (Propranolol Hydrochloride).

Propranolol; Hydrochlorothiazide (Propranolol Hydrochloride) does not affect the pharmacokinetics of verapamil and norverapamil. Verapamil does not affect the pharmacokinetics of Propranolol; Hydrochlorothiazide (Propranolol Hydrochloride).

Non-Cardiovascular Drugs

Migraine Drugs

Administration of zolmitriptan or rizatriptan with Propranolol; Hydrochlorothiazide (Propranolol Hydrochloride) resulted in increased concentrations of zolmitriptan (AUC increased by 56% and Cmax by 37%) or rizatriptan (the AUC and Cmax were increased by 67% and 75%, respectively).

Theophylline

Co-administration of theophylline with Propranolol; Hydrochlorothiazide (Propranolol Hydrochloride) decreases theophylline clearance by 33% to 52%.

Benzodiazepines

Propranolol; Hydrochlorothiazide (Propranolol Hydrochloride) can inhibit the metabolism of diazepam, resulting in increased concentrations of diazepam and its metabolites. Diazepam does not alter the pharmacokinetics of Propranolol; Hydrochlorothiazide (Propranolol Hydrochloride).

The pharmacokinetics of oxazepam, triazolam, lorazepam, and alprazolam are not affected by co-administration of Propranolol; Hydrochlorothiazide (Propranolol Hydrochloride).

Neuroleptic Drugs

Co-administration of Propranolol; Hydrochlorothiazide (Propranolol Hydrochloride) at doses greater than or equal to 160 mg/day resulted in increased thioridazine plasma concentrations ranging from 50% to 370% and increased thioridazine metabolites concentrations ranging from 33% to 210%.

Co-administration of chlorpromazine with Propranolol; Hydrochlorothiazide (Propranolol Hydrochloride) resulted in increased plasma levels of both drugs (70% increase in Propranolol; Hydrochlorothiazide (Propranolol Hydrochloride) concentrations).

Anti-Ulcer Drugs

Co-administration of Propranolol; Hydrochlorothiazide (Propranolol Hydrochloride) with cimetidine, a non-specific CYP450 inhibitor, increased Propranolol; Hydrochlorothiazide (Propranolol Hydrochloride) concentrations by about 40%. Co‑administration with aluminum hydroxide gel (1200 mg) resulted in a 50% decrease in Propranolol; Hydrochlorothiazide (Propranolol Hydrochloride) concentrations.

Co-administration of metoclopramide with Propranolol; Hydrochlorothiazide (Propranolol Hydrochloride) did not have a significant effect on propranolol’s pharmacokinetics.

Lipid Lowering Drugs

Co-administration of cholesteramine or colestipol with Propranolol; Hydrochlorothiazide (Propranolol Hydrochloride) resulted in up to 50% decrease in Propranolol; Hydrochlorothiazide (Propranolol Hydrochloride) concentrations.

Co-administration of Propranolol; Hydrochlorothiazide (Propranolol Hydrochloride) with lovastatin or pravastatin decreased 20% to 25% the AUC of both, but did not alter their pharmacodynamics. Propranolol; Hydrochlorothiazide (Propranolol Hydrochloride) did not have an effect on the pharmacokinetics of fluvastatin.

Warfarin

Concomitant administration of Propranolol; Hydrochlorothiazide (Propranolol Hydrochloride) and warfarin has been shown to increase warfarin bioavailability and increase prothrombin time.

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CLINICAL STUDIES

In a series of 225 patients with supraventricular (n = 145), ventricular (n = 69), or both (n = 11) arrythmias resistant to digitalis, intravenous Propranolol; Hydrochlorothiazide (Propranolol Hydrochloride) hydrochloride was administered in single doses, averaging 1 to 5 mg. Approximately one-quarter of the patients with supraventricular arrhythmias (generally those with sinus or atrial tachycardia) reverted to normal sinus rhythm. About one-half had symptoms ameliorated either by a decrease in ventricular rate or an attenuation of frequency or severity of paroxysmal attacks.

Approximately one-half of patients with ventricular arrhythmias (generally those with frequent PVCs) reverted to normal sinus rhythm or responded with a reduction in ventricular rate.

Similar findings were seen in a series of 25 Bantu patients with atrial fibrillation (n = 16), sinus tachycardia (n = 5), and multifocal ventricular extrasystoles (n = 9).

In another series, 7 of 8 patients with digitalis-related tachyarrhythmia had ventricular rate decreases after intravenous Propranolol; Hydrochlorothiazide (Propranolol Hydrochloride). Similarly limited clinical experience has shown that intravenous Propranolol; Hydrochlorothiazide (Propranolol Hydrochloride) will slow the ventricular rate in patients with Wolff-Parkinson-White syndrome or with tachycardia associated with thyrotoxicosis.

Onset of activity is usually within five minutes.

INDICATIONS & USAGE

Cardiac Arrhythmias

Intravenous administration is usually reserved for life-threatening arrhythmias or those occurring under anesthesia.

1. Supraventricular arrhythmias

Intravenous Propranolol; Hydrochlorothiazide (Propranolol Hydrochloride) is indicated for the short-term treatment of supraventricular tachycardia, including Wolff‑Parkinson‑White syndrome and thyrotoxicosis, to decrease ventricular rate. Use in patients with atrial flutter or atrial fibrillation should be reserved for arrythmias unresponsive to standard therapy or when more prolonged control is required. Reversion to normal sinus rhythm has occasionally been observed, predominantly in patients with sinus or atrial tachycardia.

2. Ventricular tachycardias

With the exception of those induced by catecholamines or digitalis, Propranolol; Hydrochlorothiazide (Propranolol Hydrochloride) is not the drug of first choice. In critical situations when cardioversion techniques or other drugs are not indicated or are not effective, Propranolol; Hydrochlorothiazide (Propranolol Hydrochloride) may be considered. If, after consideration of the risks involved, Propranolol; Hydrochlorothiazide (Propranolol Hydrochloride) is used, it should be given intravenously in low dosage and very slowly, as the failing heart requires some sympathetic drive for maintenance of myocardial tone. Some patients may respond with complete reversion to normal sinus rhythm, but reduction in ventricular rate is more likely. Ventricular arrhythmias do not respond to Propranolol; Hydrochlorothiazide (Propranolol Hydrochloride) as predictably as do the supraventricular arrhythmias.

Intravenous Propranolol; Hydrochlorothiazide (Propranolol Hydrochloride) is indicated for the treatment of persistent premature ventricular extrasystoles that impair the well‑being of the patient and do not respond to conventional measures.

3. Tachyarrhythmias of digitalis intoxication

Intravenous Propranolol; Hydrochlorothiazide (Propranolol Hydrochloride) is indicated to control ventricular rate in life-threatening digitalis-induced arrhythmias. Severe bradycardia may occur.

4. Resistant tachyarrhythmias due to excessive catecholamine action during anesthesia

Intravenous Propranolol; Hydrochlorothiazide (Propranolol Hydrochloride) is indicated to abolish tachyarrhythmias due to excessive catecholamine action during anesthesia when other measures fail. These arrhythmias may arise because of release of endogenous catecholamines or administration of catecholamines. All general inhalation anesthetics produce some degree of myocardial depression. Therefore, when Propranolol; Hydrochlorothiazide (Propranolol Hydrochloride) is used to treat arrhythmias during anesthesia, it should be used with extreme caution, usually with constant monitoring of the ECG and central venous pressure.

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CONTRAINDICATIONS

Propranolol; Hydrochlorothiazide (Propranolol Hydrochloride) is contraindicated in 1) cardiogenic shock; 2) sinus bradycardia and greater than first-degree block; 3) bronchial asthma; and 4) in patients with known hypersensitivity to Propranolol; Hydrochlorothiazide (Propranolol Hydrochloride) hydrochloride.

WARNINGS

Cardiac Failure

Sympathetic stimulation may be a vital component supporting circulatory function in patients with congestive heart failure, and its inhibition by beta blockade may precipitate more severe failure. Although beta-blockers should be avoided in overt congestive heart failure, some have been shown to be highly beneficial when used with close follow-up in patients with a history of failure who are well compensazted and are receiving additional therapies, including diiuretics as needed. Beta-adrenergic blocking agents do not abolish the inotropic action of digitalis on heart muscle.

Nonallergic Bronchospasm (e.g., Chronic Bronchitis, Emphysema)

In general, patients with bronchospastic lung disease should not receive beta blockers. Propranolol; Hydrochlorothiazide (Propranolol Hydrochloride) should be administered with caution in this setting 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 in propranolol-treated patients might augment the risks of general anesthesia and surgical procedures.

Propranolol; Hydrochlorothiazide (Propranolol Hydrochloride) 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.

Diabetes and Hypoglycemia

Beta-adrenergic blockade may prevent the appearance of certain premonitory signs and symptoms (pulse rate and pressure changes) of acute hypoglycemia, especially in labile insulin-dependent diabetics. In these patients, it may be more difficult to adjust the dosage of insulin.

Propranolol; Hydrochlorothiazide (Propranolol Hydrochloride) therapy, particularly in infants and children, diabetic or not, has been associated with hypoglycemia especially during fasting, as in preparation for surgery. Hypoglycemia has been reported after prolonged physical exertion and in patients with renal insufficiency.

Thyrotoxicosis

Beta-adrenergic blockade may mask certain clinical signs of hyperthyroidism. Therefore, abrupt withdrawal of Propranolol; Hydrochlorothiazide (Propranolol Hydrochloride) may be followed by an exacerbation of symptoms of hyperthyroidism, including thyroid storm. Propranolol; Hydrochlorothiazide (Propranolol Hydrochloride) may change thyroid-function tests, increasing T4 and reverse T3, and decreasing T3.

Wolff-Parkinson-White Syndrome

Beta-adrenergic blockade in patients with Wolff-Parkinson-White syndrome and tachycardia has been associated with severe bradycardia requiring treatment with a pacemaker. In one case this resulted after an initial 5 mg dose of intravenous Propranolol; Hydrochlorothiazide (Propranolol Hydrochloride).

PRECAUTIONS

General

Propranolol; Hydrochlorothiazide (Propranolol Hydrochloride) should be used with caution in patients with impaired hepatic or renal function.

Propranolol; Hydrochlorothiazide (Propranolol Hydrochloride) is not indicated for the treatment of hypertensive emergencies.

Beta-adrenergic receptor blockade can cause reduction of intraocular pressure. Patients should be told that Propranolol; Hydrochlorothiazide (Propranolol Hydrochloride) might interfere with the glaucoma screening test. Withdrawal may lead to a return of elevated intraocular pressure.

Risk of anaphylactic reaction. While taking beta blockers, patients with a history of severe anaphylactic reaction to a variety of allergens may be more reactive to repeated challenge, either accidental, diagnostic, or therapeutic. Such patients may be unresponsive to the usual doses of epinephrine used to treat allergic reaction.

Angina Pectoris

There have been reports of exacerbation of angina and, in some cases, myocardial infarction, following abrupt discontinuance of Propranolol; Hydrochlorothiazide (Propranolol Hydrochloride) therapy. Therefore, when discontinuance of Propranolol; Hydrochlorothiazide (Propranolol Hydrochloride) is planned, the dosage should be gradually reduced over at least a few weeks, and the patient should be cautioned against interruption or cessation of therapy without a physician’s advice. If Propranolol; Hydrochlorothiazide (Propranolol Hydrochloride) therapy is interrupted and exacerbation of angina occurs, it is usually advisable to reinstitute Propranolol; Hydrochlorothiazide (Propranolol Hydrochloride) therapy and take other measures appropriate for the management of 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; Hydrochlorothiazide (Propranolol Hydrochloride) for other indications.

Clinical Laboratory Tests

In patients with hypertension, use of Propranolol; Hydrochlorothiazide (Propranolol Hydrochloride) has been associated with elevated levels of serum potassium, serum transaminases and alkaline phosphatase. In severe heart failure, the use of Propranolol; Hydrochlorothiazide (Propranolol Hydrochloride) has been associated with increases in Blood Urea Nitrogen.

Drug Interactions

Caution should be exercised when Propranolol; Hydrochlorothiazide (Propranolol Hydrochloride) is administered with drugs that have an effect on CYP2D6, 1A2, or 2C19 metabolic pathways. Co-administration of such drugs with Propranolol; Hydrochlorothiazide (Propranolol Hydrochloride) may lead to clinically relevant drug interactions and changes in its efficacy and/or toxicity (see CLINICAL PHARMACOLOGY, DRUG INTERACTIONS.

Cardiovascular Drugs

Antirrhythmics

Propafenone has negative inotropic and beta-blocking properties that can be additive to those of Propranolol; Hydrochlorothiazide (Propranolol Hydrochloride).

Quinidine increases the concentration of Propranolol; Hydrochlorothiazide (Propranolol Hydrochloride) and produces a greater degree of clinical beta-blockade and may cause postural hypotension.

Disopyramide is a Type I antiarrhythmic drug with potent negative inotropic and chronotropic effects and has been associated with severe bradycardia, asystole and heart failure when administered with Propranolol; Hydrochlorothiazide (Propranolol Hydrochloride).

Amiodarone is an antiarrhythmic agent with negative chronotropic properties that may be additive to those seen with Propranolol; Hydrochlorothiazide (Propranolol Hydrochloride).

The clearance of lidocaine is reduced when administered with Propranolol; Hydrochlorothiazide (Propranolol Hydrochloride). Lidocaine toxicity has been reported following co-administration with Propranolol; Hydrochlorothiazide (Propranolol Hydrochloride).

Caution should be exercised when administering Propranolol; Hydrochlorothiazide (Propranolol Hydrochloride) with drugs that slow A-V nodal conduction, e.g., digitalis, lidocaine and calcium channel blockers.

Calcium Channel Blockers

Caution should be exercised when patients receiving a beta-blocker are administered a calcium-channel-blocking drug with negative inotropic and/or chronotropic effects. Both agents may depress myocardial contractility or atrioventricular conduction.

There have been reports of significant bradycardia, heart failure, and cardiovascular collapse with concurrent use of verapamil and beta‑blockers.

Co-administration of Propranolol; Hydrochlorothiazide (Propranolol Hydrochloride) and diltiazem in patients with cardiac disease has been associated with bradycardia, hypotension, high degree heart block, and heart failure.

ACE Inhibitors

When combined with beta-blockers, ACE inhibitors can cause hypotension, particularly in the setting of acute myocardial infarction.

ACE inhibitors have been reported to increase bronchial hyperreactivity when administered with Propranolol; Hydrochlorothiazide (Propranolol Hydrochloride).

The antihypertensive effects of clonidine may be antagonized by beta-blockers. Propranolol; Hydrochlorothiazide (Propranolol Hydrochloride) should be administered cautiously to patients withdrawing from clonidine.

Alpha-blockers

Prazosin has been associated with prolongation of first dose hypotension in the presence of beta-blockers.

Postural hypotension has been reported in patients taking both beta-blockers and terazosin or doxazosin.

Reserpine

Patients receiving catecholamine-depleting drugs, such as reserpine, with Propranolol; Hydrochlorothiazide (Propranolol Hydrochloride) should be closely observed for excess reduction of resting sympathetic nervous activity, which may result in hypotension, marked bradycardia, vertigo, syncopal attacks, or orthostatic hypotension. Administration of reserpine with Propranolol; Hydrochlorothiazide (Propranolol Hydrochloride) may also potentiate depression.

Inotropic Agents

Patients on long-term therapy with Propranolol; Hydrochlorothiazide (Propranolol Hydrochloride) may experience uncontrolled hypertension if administered epinephrine as a consequence of unopposed alpha-receptor stimulation. Epinephrine is therefore not indicated in the treatment of Propranolol; Hydrochlorothiazide (Propranolol Hydrochloride) overdose.

Isoproterenol and Dobutamine

Propranolol is a competitive inhibitor of beta-receptor agonists, and its effects can be reversed by administration of such agents, e.g., dobutamine or isoproterenol. Also, Propranolol; Hydrochlorothiazide (Propranolol Hydrochloride) may reduce sensitivity to dobutamine stress echocardiography in patients undergoing evaluation for myocardial ischemia.

Non-Cardiovascular Drugs

Non-Steroidal Anti-Inflammatory Drugs

Non-steroidal anti-inflammatory drugs (NSAIDs) have been reported to blunt the antihypertensive effect of beta-adrenoreceptor blocking agents.

Administration of indomethacin with Propranolol; Hydrochlorothiazide (Propranolol Hydrochloride) may reduce the efficacy of Propranolol; Hydrochlorothiazide (Propranolol Hydrochloride) in reducing blood pressure and heart rate.

Antidepressants

The hypotensive effects of MAO inhibitors or tricyclic antidepressants may be exacerbated when administered with beta-blockers by interfering with the beta blocking activity of Propranolol; Hydrochlorothiazide (Propranolol Hydrochloride).

Anesthetic Agents

Methoxyflurane and trichloroethylene may depress myocardial contractility when administered with Propranolol; Hydrochlorothiazide (Propranolol Hydrochloride).

Warfarin

Administration of Propranolol; Hydrochlorothiazide (Propranolol Hydrochloride) with warfarin increases the concentration of warfarin. Therefore, the prothrombin time should be monitored.

Neuroleptic Drugs

Hypotension and cardiac arrest have been reported with the concomitant use of Propranolol; Hydrochlorothiazide (Propranolol Hydrochloride) and haloperidol.

Thyroxine

Thyroxine may result in a lower than expected T3 concentration when used concomitantly with Propranolol; Hydrochlorothiazide (Propranolol Hydrochloride).

Carcinogenesis, Mutagenesis, Impairment of Fertility

In dietary administration studies in which mice and rats were treated with Propranolol; Hydrochlorothiazide (Propranolol Hydrochloride) hydrochloride for up to 18 months at doses of up to 150 mg/kg/day, there was no evidence of drug-related tumorigenesis. On a body surface area basis, this dose in the mouse and rat is, respectively, about equal to and about twice the maximum recommended human oral daily dose (MRHD) of 640 mg Propranolol; Hydrochlorothiazide (Propranolol Hydrochloride) hydrochloride. In a study in which both male and female rats were exposed to Propranolol; Hydrochlorothiazide (Propranolol Hydrochloride) hydrochloride in their diets at concentrations of up to 0.05% (about 50 mg/kg body weight and less than the MRHD), from 60 days prior to mating and throughout pregnancy and lactation for two generations, there were no effects on fertility. Based on differing results from Ames Tests performed by different laboratories, there is equivocal evidence for a genotoxic effect of Propranolol; Hydrochlorothiazide (Propranolol Hydrochloride) hydrochloride in bacteria (S. typhimurium strain TA 1538).

Pregnancy

Pregnancy Category C

In a series of reproductive and developmental toxicology studies, Propranolol; Hydrochlorothiazide (Propranolol Hydrochloride) hydrochloride was given to rats by gavage or in the diet throughout pregnancy and lactation. At doses of 150 mg/kg/day, but not at doses of 80 mg/kg/day (equivalent to the MRHD on a body surface area basis), treatment was associated with embryotoxicity (reduced litter size and increased resorption rates) as well as neonatal toxicity (deaths). Propranolol; Hydrochlorothiazide (Propranolol Hydrochloride) hydrochloride also was administered (in the feed) to rabbits (throughout pregnancy and lactation) at doses as high as 150 mg/kg/day (about 5 times the maximum recommended human oral daily dose). No evidence of embryo or neonatal toxicity was noted.

There are no adequate and well-controlled studies in pregnant women. Intrauterine growth retardation has been reported for neonates whose mothers received Propranolol; Hydrochlorothiazide (Propranolol Hydrochloride) hydrochloride during pregnancy. Neonates whose mothers received Propranolol; Hydrochlorothiazide (Propranolol Hydrochloride) hydrochloride at parturition have exhibited bradycardia, hypoglycemia, and respiratory depression. Adequate facilities for monitoring such infants at birth should be available. Propranolol; Hydrochlorothiazide (Propranolol Hydrochloride) should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

Nursing Mothers

Propranolol; Hydrochlorothiazide (Propranolol Hydrochloride) is excreted in human milk. Caution should be exercised when Propranolol; Hydrochlorothiazide (Propranolol Hydrochloride) is administered to a nursing woman.

Pediatric Use

Safety and effectiveness of Propranolol; Hydrochlorothiazide (Propranolol Hydrochloride) in pediatric patients have not been established.

Geriatric Use

Clinical studies of intravenous Propranolol; Hydrochlorothiazide (Propranolol Hydrochloride) did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Elderly subjects have decreased clearance and a longer mean elimination half‑life. These findings suggest that dose adjustment of Propranolol; Hydrochlorothiazide (Propranolol Hydrochloride) injection may be required for elderly patients. In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of the decreased hepatic, renal or cardiac function, and of concomitant disease or other drug therapy.

Hepatic Insufficiency

Propranolol; Hydrochlorothiazide (Propranolol Hydrochloride) is extensively metabolized by the liver. Compared to normal subjects, patients with chronic liver disease have decreased clearance of Propranolol; Hydrochlorothiazide (Propranolol Hydrochloride), increased volume of distribution, decreased protein-binding and considerable variation in half life. Consideration should be given to lowering the dose of intravenously administered Propranolol; Hydrochlorothiazide (Propranolol Hydrochloride) in patients with hepatic insufficiency.

ADVERSE REACTIONS

In a series of 225 patients, there were 6 deaths. Cardiovascular events (hypotension, congestive heart failure, bradycardia, and heart block) were the most common. The only other event reported by more than one patient was nausea.

Other adverse events for intravenous Propranolol; Hydrochlorothiazide (Propranolol Hydrochloride), reported during post-marketing surveillance include cardiac arrest, dyspnea, and cutaneous ulcers.

The following adverse events have been reported with use of formulations of sustained- or immediate-release oral Propranolol; Hydrochlorothiazide (Propranolol Hydrochloride) and may be expected with intravenous Propranolol; Hydrochlorothiazide (Propranolol Hydrochloride).

Cardiovascular

Bradycardia; congestive heart failure; intensification of AV block; hypotension; paresthesia of hands; thrombocytopenic purpura; arterial insufficiency, usually of the Raynaud type.

Central Nervous System

Light-headedness; mental depression manifested by insomnia, lassitude, weakness, fatigue; reversible mental depression progressing to catatonia; visual disturbances; hallucinations; vivid dreams; an acute reversible syndrome characterized by disorientation for time and place, short-term memory loss, emotional lability, slightly clouded sensorium, and decreaseed performance on neuropsychometrics. For immediate-release formulations, fatigue, lethargy, and vivid dreams appear dose-related.

Gastrointestinal

Nausea, vomiting, epigastric distress, abdominal cramping, diarrhea, constipation, mesenteric arterial thrombosis, ischemic colitis.

Allergic

Pharyngitis and agranulocytosis; erythematous rash, fever combined with aching and sore throat; laryngospasm, and respiratory distress.

Respiratory

Bronchospasm.

Hematologic

Agranulocytosis, nonthrombocytopenic purpura, thrombocytopenic purpura.

Autoimmune

In extremely rare instances, systemic lupus erythematosus has been reported.

Miscellaneous

Alopecia, LE-like reactions, psoriform rashes, dry eyes, male impotence, and Peyronie's disease have been reported rarely. Oculomucocutaneous reactions involving the skin, serous membranes and conjunctivae reported for a beta-blocker (practolol) have not been associated with Propranolol; Hydrochlorothiazide (Propranolol Hydrochloride).

To report SUSPECTED ADVERSE REACTIONS, contact West-ward Pharmaceutical Corp. at 1-877-233-2001 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

OVERDOSAGE

Propranolol; Hydrochlorothiazide (Propranolol Hydrochloride) is not significantly dialyzable. In the event of overdose or exaggerated response, the following measures should be employed:

Hypotension and bradycardia have been reported following Propranolol; Hydrochlorothiazide (Propranolol Hydrochloride) overdose and should be treated appropriately. Glucagon can exert potent inotropic and chronotropic effects and may be particularly useful for the treatment of hypotension or depressed myocardial function after a Propranolol; Hydrochlorothiazide (Propranolol Hydrochloride) overdose. Glucagon should be administered as 50-150 mcg/kg intravenously followed by continuous drip of 1-5 mg/hour for positive chronotropic effect. Isoproterenol, dopamine, or phosphodiesterase inhibitors may also be useful. Epinephrine, however, may provoke uncontrolled hypertension. Bradycardia can be treated with atropine or isoproterenol. Serious bradycardia may require temporary cardiac pacing.

The electrocardiogram, pulse, blood pressure, neurobehavioral status and intake and output balance must be monitored. Isoproterenol and aminophylline may be useful for bronchospasm.

DOSAGE & ADMINISTRATION

Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.

The usual dose is 1 to 3 mg administered under careful monitoring, such as electrocardiography and central venous pressure. The rate of administration should not exceed 1 mg (1 mL) per minute to diminish the possibility of lowering blood pressure and causing cardiac standstill. Sufficient time should be allowed for the drug to reach the site of action even when a slow circulation is present. If necessary, a second dose may be given after two minutes. Thereafter, additional drug should not be given in less than four hours. Additional Propranolol; Hydrochlorothiazide (Propranolol Hydrochloride) hydrochloride should not be given when the desired alteration in rate or rhythm is achieved.

Transfer to oral therapy as soon as possible.

HOW SUPPLIED

Each mL contains 1 mg of Propranolol; Hydrochlorothiazide (Propranolol Hydrochloride) Hydrochloride, USP in Water for Injection, USP. The pH is adjusted with anhydrous Citric Acid, USP. Supplied as: 1 mL vials in boxes of 10 (NDC 0143-9872-10).

Store at 20° to 25°C (68° to 77°F). Protect from freezing or excessive heat.

Manufactured by: HIKMA FARMACÊUTICA (PORTUGAL), S.A.

Estrada do Rio da Mó, 8, 8A e 8B – Fervença – 2705-906 Terrugem SNT, PORTUGAL

Distributed by: WEST-WARD PHARMACEUTICAL CORP.

Eatontown, NJ 07724 USA

Rev.: 05/2015

PIN166-WES/4

Propranolol; Hydrochlorothiazide pharmaceutical active ingredients containing related brand and generic drugs:

infoActive ingredient is the part of the drug or medicine which is biologically active. This portion of the drug is responsible for the main action of the drug which is intended to cure or reduce the symptom or disease. The other portions of the drug which are inactive are called excipients; there role is to act as vehicle or binder. In contrast to active ingredient, the inactive ingredient's role is not significant in the cure or treatment of the disease. There can be one or more active ingredients in a drug.


Propranolol; Hydrochlorothiazide available forms, composition, doses:

infoForm of the medicine is the form in which the medicine is marketed in the market, for example, a medicine X can be in the form of capsule or the form of chewable tablet or the form of tablet. Sometimes same medicine can be available as injection form. Each medicine cannot be in all forms but can be marketed in 1, 2, or 3 forms which the pharmaceutical company decided based on various background research results.
Composition is the list of ingredients which combinedly form a medicine. Both active ingredients and inactive ingredients form the composition. The active ingredient gives the desired therapeutic effect whereas the inactive ingredient helps in making the medicine stable.
Doses are various strengths of the medicine like 10mg, 20mg, 30mg and so on. Each medicine comes in various doses which is decided by the manufacturer, that is, pharmaceutical company. The dose is decided on the severity of the symptom or disease.


Propranolol; Hydrochlorothiazide destination | category:

infoDestination is defined as the organism to which the drug or medicine is targeted. For most of the drugs what we discuss, human is the drug destination.
Drug category can be defined as major classification of the drug. For example, an antihistaminic or an antipyretic or anti anginal or pain killer, anti-inflammatory or so.


Propranolol; Hydrochlorothiazide Anatomical Therapeutic Chemical codes:

infoA medicine is classified depending on the organ or system it acts [Anatomical], based on what result it gives on what disease, symptom [Therapeutical], based on chemical composition [Chemical]. It is called as ATC code. The code is based on Active ingredients of the medicine. A medicine can have different codes as sometimes it acts on different organs for different indications. Same way, different brands with same active ingredients and same indications can have same ATC code.


Propranolol; Hydrochlorothiazide pharmaceutical companies:

infoPharmaceutical companies are drug manufacturing companies that help in complete development of the drug from the background research to formation, clinical trials, release of the drug into the market and marketing of the drug.
Researchers are the persons who are responsible for the scientific research and is responsible for all the background clinical trials that resulted in the development of the drug.


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References

  1. Dailymed."HYDROCHLOROTHIAZIDE TABLET [QUALITEST PHARMACEUTICALS]". https://dailymed.nlm.nih.gov/dailym... (accessed August 28, 2018).
  2. Dailymed."PROPRANOLOL HYDROCHLORIDE TABLET [BRYANT RANCH PREPACK]". https://dailymed.nlm.nih.gov/dailym... (accessed August 28, 2018).
  3. Dailymed."AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMIL: 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/dailym... (accessed August 28, 2018).

Frequently asked Questions

Can i drive or operate heavy machine after consuming Propranolol; Hydrochlorothiazide?

Depending on the reaction of the Propranolol; Hydrochlorothiazide after taken, if you are feeling dizziness, drowsiness or any weakness as a reaction on your body, Then consider Propranolol; Hydrochlorothiazide not safe to drive or operate heavy machine after consumption. Meaning that, do not drive or operate heavy duty machines after taking the capsule if the capsule has a strange reaction on your body like dizziness, drowsiness. As prescribed by a pharmacist, it is dangerous to take alcohol while taking medicines as it exposed patients to drowsiness and health risk. Please take note of such effect most especially when taking Primosa capsule. It's advisable to consult your doctor on time for a proper recommendation and medical consultations.

Is Propranolol; Hydrochlorothiazide addictive or habit forming?

Medicines are not designed with the mind of creating an addiction or abuse on the health of the users. Addictive Medicine is categorically called Controlled substances by the government. For instance, Schedule H or X in India and schedule II-V in the US are controlled substances.

Please consult the medicine instruction manual on how to use and ensure it is not a controlled substance.In conclusion, self medication is a killer to your health. Consult your doctor for a proper prescription, recommendation, and guidiance.

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Review

sDrugs.com conducted a study on Propranolol; Hydrochlorothiazide, and the result of the survey is set out below. It is noteworthy that the product of the survey is based on the perception and impressions of the visitors of the website as well as the views of Propranolol; Hydrochlorothiazide consumers. We, as a result of this, advice that you do not base your therapeutic or medical decisions on this result, but rather consult your certified medical experts for their recommendations.

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The information was verified by Dr. Arunabha Ray, MD Pharmacology

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