BP-Loride

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BP-Loride uses

BP-Loride consists of Amiloride Hydrochloride, Atenolol, Hydrochlorothiazide.

Amiloride Hydrochloride:


INDICATIONS AND USAGE

BP-Loride (Amiloride Hydrochloride) hydrochloride and hydrochlorothiazide tablets are indicated in those patients with hypertension or with congestive heart failure who develop hypokalemia when thiazides or other kaliuretic diuretics are used alone, or in whom maintenance of normal serum potassium levels is considered to be clinically important, e.g., digitalized patients, or patients with significant cardiac arrhythmias.

The use of potassium-conserving agents is often unnecessary in patients receiving diuretics for uncomplicated essential hypertension when such patients have a normal diet.

BP-Loride (Amiloride Hydrochloride) hydrochloride and hydrochlorothiazide tablets may be used alone or as an adjunct to other antihypertensive drugs, such as methyldopa or beta blockers. Since BP-Loride (Amiloride Hydrochloride) hydrochloride and hydrochlorothiazide enhances the action of these agents, dosage adjustments may be necessary to avoid an excessive fall in blood pressure and other unwanted side effects.

The fixed combination drug is not indicated for the initial therapy of edema or hypertension except in individuals in whom the development of hypokalemia cannot be risked.

CONTRAINDICATIONS

Hyperkalemia

BP-Loride hydrochloride and hydrochlorothiazide tablets should not be used in the presence of elevated serum potassium levels (greater than 5.5 mEq per liter).

Antikaliuretic Therapy or Potassium Supplementation

BP-Loride (Amiloride Hydrochloride) hydrochloride and hydrochlorothiazide should not be given to patients receiving other potassium-conserving agents, such as spironolactone or triamterene. Potassium supplementation in the form of medication, potassium-containing salt substitutes or a potassium-rich diet should not be used with this product except in severe and/or refractory cases of hypokalemia. Such concomitant therapy can be associated with rapid increases in serum potassium levels. If potassium supplementation is used, careful monitoring of the serum potassium level is necessary.

Impaired Renal Function

Anuria, acute or chronic renal insufficiency, and evidence of diabetic nephropathy are contraindications to the use of BP-Loride hydrochloride and hydrochlorothiazide. Patients with evidence of renal function impairment (blood urea nitrogen [BUN] levels over 30 mg per 100 mL or serum creatinine levels over 1.5 mg per 100 mL) or diabetes mellitus should not receive the drug without careful, frequent and continuing monitoring of serum electrolytes, creatinine, and BUN levels. Potassium retention associated with the use of an antikaliuretic agent is accentuated in the presence of renal impairment and may result in the rapid development of hyperkalemia.

Hypersensitivity

BP-Loride (Amiloride Hydrochloride) hydrochloride and hydrochlorothiazide tablets is contraindicated in patients who are hypersensitive to this product, or to other sulfonamide-derived drugs.

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WARNINGS

Hyperkalemia

Like other potassium-conserving diuretic combinations, BP-Loride and hydrochlorothiazide may cause hyperkalemia (serum potassium levels greater than 5.5 mEq per liter). In patients without renal impairment or diabetes mellitus, the risk of hyperkalemia with this combination product is about 1 to 2 percent. This risk is higher in patients with renal impairment or diabetes mellitus (even without recognized diabetic nephropathy). Since hyperkalemia, if uncorrected, is potentially fatal, it is essential to monitor serum potassium levels carefully in any patient receiving BP-Loride (Amiloride Hydrochloride) hydrochloride and hydrochlorothiazide, particularly when it is first introduced, at the time of dosage adjustments, and during any illness that could affect renal function.

The risk of hyperkalemia may be increased when potassium-conserving agents, including BP-Loride (Amiloride Hydrochloride) hydrochloride and hydrochlorothiazide, are administered concomitantly with an angiotensin-converting enzyme inhibitor, cylosporine or tacrolimus. Warning signs or symptoms of hyperkalemia include paresthesias, muscular weakness, fatigue, flaccid paralysis of the extremities, bradycardia, shock, and ECG abnormalities. Monitoring of the serum potassium level is essential because mild hyperkalemia is not usually associated with an abnormal ECG.

When abnormal, the ECG in hyperkalemia is characterized primarily by tall, peaked T waves or elevations from previous tracings. There may also be lowering of the R wave and increased depth of the S wave, widening and even disappearance of the P wave, progressive widening of the QRS complex, prolongation of the PR interval, and ST depression.

Treatment of Hyperkalemia

If hyperkalemia occurs in patients taking BP-Loride (Amiloride Hydrochloride) and hydrochlorothiazide, the drug should be discontinued immediately. If the serum potassium level exceeds 6.5 mEq per liter, active measures should be taken to reduce it. Such measures include the intravenous administration of sodium bicarbonate solution or oral or parenteral glucose with a rapid-acting insulin preparation. If needed, a cation exchange resin such as sodium polystyrene sulfonate may be given orally or by enema. Patients with persistent hyperkalemia may require dialysis.

Diabetes Mellitus

In diabetic patients, hyperkalemia has been reported with the use of all potassium-conserving diuretics, including BP-Loride HCl, even in patients without evidence of diabetic nephropathy. Therefore, BP-Loride (Amiloride Hydrochloride) and hydrochlorothiazide should be avoided, if possible, in diabetic patients and, if it is used, serum electrolytes and renal function must be monitored frequently.

BP-Loride (Amiloride Hydrochloride) and hydrochlorothiazide should be discontinued at least three days before glucose tolerance testing.

Metabolic or Respiratory Acidosis

Antikaliuretic therapy should be instituted only with caution in severely ill patients in whom respiratory or metabolic acidosis may occur, such as patients with cardiopulmonary disease or poorly controlled diabetes. If BP-Loride (Amiloride Hydrochloride) and hydrochlorothiazide is given to these patients, frequent monitoring of acid-base balance is necessary. Shifts in acid-base balance alter the ratio of extracellular/intracellular potassium, and the development of acidosis may be associated with rapid increases in serum potassium levels.

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PRECAUTIONS

General

Electrolyte Imbalance and BUN Increases

Determination of serum electrolytes to detect possible electrolyte imbalance should be performed at appropriate intervals.

Patients should be observed for clinical signs of fluid or electrolytes imbalance: i.e., hyponatremia, hypochloremic alkalosis, and hypokalemia. Serum and urine electrolyte determinations are particularly important when the patient is vomiting excessively or receiving parenteral fluids. Warning signs or symptoms of fluid and electrolyte imbalance, irrespective of cause, include dryness of mouth, thirst, weakness, lethargy, drowsiness, restlessness, confusion, seizures, muscle pains or cramps, muscular fatigue, hypotension, oliguria, tachycardia, and gastrointestinal disturbances such as nausea and vomiting.

Hyponatremia and hypochloremia may occur during the use of thiazides and other diuretics. Any chloride deficit during thiazide therapy is generally mild and may be lessened by the BP-Loride HCl component of this product. Hypochloremia usually does not require specific treatment except under extraordinary circumstances (as in liver disease or renal disease). Dilutional hyponatremia may occur in edematous patients in hot weather; appropriate therapy is water restriction, rather than administration of salt, except in rare instances when the hyponatremia is life threatening. In actual salt depletion, appropriate replacement is the therapy of choice.

Hypokalemia may develop during thiazide therapy, especially with brisk diuresis, when severe cirrhosis is present, during concomitant use of corticosteroids or ACTH, or after prolonged therapy. However, this usually is prevented by the BP-Loride (Amiloride Hydrochloride) hydrochloride component of this combination drug product.

Interference with adequate oral electrolyte intake will also contribute to hypokalemia. Hypokalemia may cause cardiac arrhythmia and may also sensitize or exaggerate the response of the heart to the toxic effects of digitalis (e.g., increased ventricular irritability).

Thiazides have been shown to increase the urinary excretion of magnesium; this may result in hypomagnesemia. BP-Loride (Amiloride Hydrochloride) hydrochloride, a component of this combination product, has been shown to decrease the enhanced urinary excretion of magnesium which occurs when a thiazide or loop diuretic is used alone.

Increases in BUN levels have been reported with BP-Loride (Amiloride Hydrochloride) hydrochloride and with hydrochlorothiazide. These increases usually have accompanied vigorous fluid elimination, especially when diuretic therapy was used in seriously ill patients, such as those who had hepatic cirrhosis with ascites and metabolic alkalosis, or those with resistant edema. Therefore, when BP-Loride (Amiloride Hydrochloride) and hydrochlorothiazide is given to such patients, careful monitoring of serum electrolyte and BUN levels is important. In patients with pre-existing severe liver disease, hepatic encephalopathy, manifested by tremors, confusion, and coma, and increased jaundice, have been reported in association with diuretic therapy including BP-Loride (Amiloride Hydrochloride) HCl and hydrochlorothiazide.

In patients with renal disease, diuretics may precipitate azotemia. Cumulative effects of the components of BP-Loride (Amiloride Hydrochloride) hydrochloride and hydrochlorothiazide may develop in patients with impaired renal function. If renal impairment becomes evident, BP-Loride (Amiloride Hydrochloride) and hydrochlorothiazide should be discontinued.

Drug Interactions

In some patients, the administration of a non-steroidal anti-inflammatory agent can reduce the diuretic, natriuretic, and antihypertensive effects of loop, potassium-sparing and thiazide diuretics. Therefore, when BP-Loride (Amiloride Hydrochloride) and hydrochlorothiazide plus non-steroidal anti-inflammatory agents are used concomitantly, the patient should be observed closely to determine if the desired effect of the diuretic is obtained. Since indomethacin and potassium-sparing diuretics, including this product, may each be associated with increased serum potassium levels, the potential effects on potassium kinetics and renal function should be considered when these agents are administered concurrently.

BP-Loride HCl

When BP-Loride (Amiloride Hydrochloride) HCl is administered concomitantly with an angiotensin-converting enzyme inhibitor, cyclosporine or tacrolimus, the risk of hyperkalemia may be increased. Therefore, if concomitant use of these agents is indicated because of demonstrated hypokalemia, they should be used with caution and with frequent monitoring of serum potassium.

Hydrochlorothiazide

When given concurrently the following drugs may interact with thiazide diuretics.

Alcohol, Barbiturates, or Narcotics

Potentiation of orthostatic hypotension may occur.

Antidiabetic Drugs

Dosage adjustment of the antidiabetic drug may be required.

Other Antihypertensive Drugs

Additive effect or potentiation.

Cholestyramine and Colestipol Resins

Absorption of hydrochlorothiazide is impaired in the presence of anionic exchange resins. Single doses of cholestyramine and colestipol resins bind the hydrochlorothiazide and reduce its absorption from the gastrointestinal tract by up to 85 and 43 percent, respectively.

Corticosteroids, ACTH

Intensified electrolyte depletion, particularly hypokalemia.

Pressor Amines

Possible decreased response to pressor amines but not sufficient to preclude their use.

Skeletal Muscle Relaxants, Nondepolarizing

Possible increased responsiveness to the muscle relaxant.

Lithium

Generally should not be given with diuretics. Diuretic agents reduce the renal clearance of lithium and add a high risk of lithium toxicity. Refer to the package insert for lithium preparations before use of such preparations with this combination product.

Metabolic and Endocrine Effects

In diabetic patients, insulin requirements may be increased, decreased, or unchanged due to the hydrochlorothiazide component. Diabetes mellitus that has been latent may become manifest during administration of thiazide diuretics.

Because calcium excretion is decreased by thiazides, BP-Loride and hydrochlorothiazide should be discontinued before carrying out tests for parathyroid function. Pathologic changes in the parathyroid glands, with hypercalcemia and hypophosphatemia have been observed in a few patients on prolonged thiazide therapy; however, the common complications of hyperparathyroidism such as renal lithiasis, bone resorption, and peptic ulceration have not been seen.

Hyperuricemia may occur or acute gout may be precipitated in certain patients receiving thiazide therapy.

Other Precautions

In patients receiving thiazides, sensitivity reactions may occur with or without a history of allergy or bronchial asthma. The possibility of exacerbation or activation of systemic lupus erythematosus has been reported with the use of thiazides.

Increases in cholesterol and triglyceride levels may be associated with thiazide diuretic therapy.

Carcinogenesis, Mutagenicity, Impairment of Fertility

Long-term studies in animals have not been performed to evaluate the effects upon fertility, mutagenicity or carcinogenic potential of BP-Loride hydrochloride and hydrochlorothiazide.

BP-Loride (Amiloride Hydrochloride) HCl

There was no evidence of a tumorigenic effect when BP-Loride (Amiloride Hydrochloride) hydrochloride was administered for 92 weeks to mice at doses up to 10 mg/kg/day (25 times the maximum daily human dose). BP-Loride (Amiloride Hydrochloride) hydrochloride has also been administered for 104 weeks to male and female rats at doses up to 6 and 8 mg/kg/day (15 and 20 times the maximum daily dose for humans, respectively) and showed no evidence of carcinogenicity.

BP-Loride (Amiloride Hydrochloride) hydrochloride was devoid of mutagenic activity in various strains of Salmonella typhimurium with or without a mammalian liver microsomal activation system (Ames test).

Hydrochlorothiazide

Two-year feeding studies in mice and rats conducted under the auspices of the National Toxicology Program uncovered no evidence of a carcinogenic potential of hydrochlorothiazide in female mice (at doses of up to approximately 600 mg/kg/day) or in male and female rats (at doses up to approximately 100 mg/kg/day). The NTP, however, found equivocal evidence for hepatocarcinogenicity in male mice.

Hydrochlorothiazide was not genotoxic in vitro in the Ames mutagenicity assay of Salmonella typhimurium strains TA 98, TA 100, TA 1535, TA 1537, and TA 1538 and in the Chinese Hamster Ovary (CHO) test for chromosomal aberrations, or in vivo in assays using mouse germinal cell chromosomes, Chinese Hamster bone marrow chromosomes, and the Drosophila sex-linked recessive lethal trait gene. Positive test results were obtained only in the in vitro CHO Sister Chromatid Exchange (clastogenicity) and in the Mouse Lymphoma Cell (mutagenicity) assays, using concentrations of hydrochlorothiazide from 43 to 1300 mcg/mL, and in the Aspergillus nidulans non-disjunction assay at an unspecified concentration.

Hydrochlorothiazide had no adverse effects on the fertility of mice and rats of either sex in studies wherein these species were exposed, via their diet, to doses of up to 100 and 4 mg/kg, respectively, prior to conception and throughout gestation.

Pregnancy

Teratogenic Effects

Pregnancy Category B

Teratogenicity studies have been performed with combinations of BP-Loride hydrochloride and hydrochlorothiazide in rabbits and mice at doses up to 25 times the expected maximum daily dose for humans and have revealed no evidence of harm to the fetus. No evidence of impaired fertility in rats was apparent at dosage levels up to 25 times the expected maximum human daily dose. A perinatal and postnatal study in rats showed a reduction in maternal body weight gain during and after gestation at a daily dose of 25 times the expected maximum daily dose for humans. The body weights of alive pups at birth and at weaning were also reduced at this dose level. There are no adequate and well-controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human responses, and because of the data listed below with the individual components, this drug should be used during pregnancy only if clearly needed.

BP-Loride (Amiloride Hydrochloride) Hydrochloride

Teratogenicity studies with BP-Loride (Amiloride Hydrochloride) hydrochloride in rabbits and mice given 20 and 25 times the maximum human dose, respectively, revealed no evidence of harm to the fetus, although studies showed that the drug crossed the placenta in modest amounts. Reproduction studies in rats at 20 times the expected maximum daily dose for humans showed no evidence of impaired fertility. At approximately 5 or more times the expected maximum daily dose for humans, some toxicity was seen in adult rats and rabbits and a decrease in rat pup growth and survival occurred.

Hydrochlorothiazide

Teratogenic Effects

Studies in which hydrochlorothiazide was orally administered to pregnant mice and rats during their respective periods of major organogenesis at doses up to 3000 and 1000 mg hydrochlorothiazide/kg, respectively, provided no evidence of harm to the fetus. There are, however, no adequate and well-controlled studies in pregnant women.

Nonteratogenic Effects

Thiazides cross the placental barrier and appear in cord blood. There is a risk of fetal or neonatal jaundice, thrombocytopenia, and possibly other adverse reactions that have occurred in adults.

Nursing Mothers

Studies in rats have shown that BP-Loride is excreted in milk in concentrations higher than those found in blood, but it is not known whether BP-Loride (Amiloride Hydrochloride) HCl is excreted in human milk. However, thiazides appear in breast milk. Because of the potential for serious adverse reactions in nursing infants, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.

Pediatric Use

Safety and effectiveness in pediatric patients have not been established.

Geriatric Use

Clinical studies of BP-Loride (Amiloride Hydrochloride) hydrochloride and hydrochlorothiazide tablets did not include sufficient numbers of subjects aged 65 and over to determine whether they responded differently from younger subjects. Other reported clinical experience has not identified differences in responses between the elderly and younger 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 decreased hepatic, renal or cardiac function, and the comitant disease or other drug therapy.

This drug is known to be substantially excreted by the kidney, and the risk of toxic reactions to this drug may be greater in patients with impaired renal function. Because elderly patients are more likely to have decreased renal function, care should be taken in dose selection, and it may be useful to monitor renal function.

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ADVERSE REACTIONS

BP-Loride hydrochloride and hydrochlorothiazide is usually well tolerated and significant clinical adverse effects have been reported infrequently. The risk of hyperkalemia (serum potassium levels greater than 5.5 mEq per liter) with BP-Loride (Amiloride Hydrochloride) hydrochloride and hydrochlorothiazide is about 1 to 2 percent in patients without renal impairment or diabetes mellitus. Minor adverse reactions to BP-Loride (Amiloride Hydrochloride) hydrochloride have been reported relatively frequently (about 20%) but the relationship of many of the reports to BP-Loride (Amiloride Hydrochloride) HCl is uncertain and the overall frequency was similar to hydrochlorothiazide treated groups. Nausea/anorexia, abdominal pain, flatulence, and mild skin rash have been reported and probably are related to BP-Loride (Amiloride Hydrochloride). Other adverse experiences that have been reported with BP-Loride (Amiloride Hydrochloride) and hydrochlorothiazide are generally those known to be associated with diuresis, thiazide therapy, or with the underlying disease being treated. Clinical trials have not demonstrated that combining BP-Loride (Amiloride Hydrochloride) and hydrochlorothiazide increases the risk of adverse reactions over those seen with the individual components.

The adverse reactions for BP-Loride (Amiloride Hydrochloride) and hydrochlorothiazide listed in the following table have been arranged into two groups: (1) incidence greater than one percent; and (2) incidence one percent or less. The incidence for group (1) was determined from clinical studies conducted in the United States (607 patients treated with BP-Loride (Amiloride Hydrochloride) and hydrochlorothiazide). The adverse effects listed in group (2) include reports from the same clinical studies and voluntary reports since marketing. The probability of a causal relationship exists between BP-Loride (Amiloride Hydrochloride) and hydrochlorothiazide and these adverse reactions, some of which have been reported only rarely.


Incidence > 1%


Incidence ≤ 1%


Body as a Whole


HeadacheReactions occurring in 3% to 8% of patients treated with BP-Loride (Amiloride Hydrochloride) hydrochloride and hydrochlorothiazide. (Those reactions occurring in less than 3% of the patients are unmarked.)

Weakness

Fatigue/tiredness


Malaise

Chest pain

Back pain

Syncope


Cardiovascular


Arrhythmia


Tachycardia

Digitalis toxicity

Orthostatic hypotension

Angina pectoris


Digestive


Nausea/anorexia

Diarrhea

Gastrointestinal pain

Abdominal pain


Constipation

GI bleeding

GI disturbance

Appetite changes

Abdominal fullness

Hiccups

Thirst

Vomiting

Anorexia

Flatulence


Metabolic


Elevated serum potassium levels

(> 5.5 mEq per liter)See WARNINGS


Gout

Dehydration

Symptomatic hyponatremiaSee PRECAUTIONS


Musculoskeletal


Leg ache


Muscle cramps/spasm

Joint pain


Nervous


Dizziness


Paresthesia/numbness

Stupor

Vertigo


Psychiatric

None


Insomnia

Nervousness

Depression

Sleepiness

Mental confusion


Respiratory


Dyspnea


None


Skin


Rash

Pruritus


Flushing

Diaphoresis

Erythema multiforme including Stevens-

Johnson syndrome

Exfoliative dermatitis including toxic

epidermal necrolysis

Alopecia


Special Senses


None


Bad taste

Visual disturbance

Nasal congestion


Urogenital


None


Impotence

Nocturia

Dysuria

Incontinence

Renal dysfunction including renal failure

Gynecomastia


Other adverse reactions that have been reported with the individual components and within each category are listed in order of decreasing severity:

BP-Loride (Amiloride Hydrochloride)

Body as a Whole: Painful extremities, neck/shoulder ache, fatigability.

Cardiovascular: Palpitation.

Digestive: Activation of probable pre-existing peptic ulcer, abnormal liver function, jaundice, dyspepsia, heartburn.

Hematologic: Aplastic anemia, neutropenia.

Integumentary: Alopecia, itching, dry mouth.

Nervous System/Psychiatric: Encephalopathy, tremors, decreased libido.

Respiratory: Shortness of breath, cough.

Special Senses: Increased intraocular pressure, tinnitus.

Urogenital: Bladder spasms, polyuria, urinary frequency.

Hydrochlorothiazide

Digestive: Pancreatitis, jaundice (intrahepatic cholestatic jaundice), sialadenitis, cramping, gastric irritation.

Hematologic: Aplastic anemia, agranulocytosis, leukopenia, hemolytic anemia, thrombocytopenia.

Hypersensitivity: Anaphylactic reactions, necrotizing angiitis (vasculitis, cutaneous vasculitis), respiratory distress including pneumonitis and pulmonary edema, photosensitivity, fever, urticaria, purpura.

Metabolic: Electrolyte imbalance, hyperglycemia, glycosuria, hyperuricemia.

Nervous System/Psychiatric: Restlessness.

Special Senses: Transient blurred vision, xanthopsia.

Urogenital: Interstitial nephritis.

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OVERDOSAGE

No data are available in regard to overdosage in humans. The oral LD50 of the combination drug is 189 and 422 mg/kg for female mice and female rats, respectively.

It is not known whether the drug is dialyzable.

No specific information is available on the treatment of overdosage with BP-Loride and hydrochlorothiazide and no specific antidote is available. Treatment is symptomatic and supportive. Therapy with BP-Loride (Amiloride Hydrochloride) and hydrochlorothiazide should be discontinued and the patient observed closely. Suggested measures include the induction of emesis and/or gastric lavage.

BP-Loride (Amiloride Hydrochloride) Hydrochloride

No data are available in regard to overdosage in humans.

The oral LD50 of BP-Loride (Amiloride Hydrochloride) hydrochloride (calculated as the base) is 56 mg/kg in mice and 36 to 85 mg/kg in rats, depending on the strain.

The most common signs and symptoms to be expected with overdosage are dehydration and electrolyte imbalance. If hyperkalemia occurs, active measures should be taken to reduce the serum potassium levels.

Hydrochlorothiazide

The oral LD50 of hydrochlorothiazide is greater than 10 g/kg in both mice and rats.

The most common signs and symptoms observed are those caused by electrolyte depletion (hypokalemia, hypochloremia, hyponatremia) and dehydration resulting from excessive diuresis. If digitalis has also been administered, hypokalemia may accentuate cardiac arrhythmias.

DOSAGE AND ADMINISTRATION

BP-Loride (Amiloride Hydrochloride) hydrochloride and hydrochlorothiazide tablets should be administered with food.

The usual starting dosage is 1 tablet a day. The dosage may be increased to 2 tablets a day, if necessary. More than 2 tablets of BP-Loride (Amiloride Hydrochloride) hydrochloride and hydrochlorothiazide daily usually are not needed and there is no controlled experience with such doses.

Hydrochlorothiazide can be given at doses of 12.5 to 50 mg per day when used alone. Patients usually do not require doses of hydrochlorothiazide in excess of 50 mg daily when combined with other antihypertensive agents. The daily dose is usually given as a single dose but may be given in divided doses. Once an initial diuresis has been achieved, dosage adjustment may be necessary. Maintenance therapy may be on an intermittent basis.

HOW SUPPLIED

BP-Loride (Amiloride Hydrochloride) Hydrochloride and Hydrochlorothiazide Tablets USP are available as:


5 mg/50 mg:


Light yellow, round, scored, biconvex tablet. Debossed with 555 over 483 on the scored side and stylized barr on the other side. Each tablet contains 5 mg of anhydrous BP-Loride (Amiloride Hydrochloride) HCl and 50 mg of hydrochlorothiazide.


100 Tablets NDC 0555-0483-02

1000 Tablets NDC 0555-0483-05


Dispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure (as required).

Store at 20º to 25ºC (68º to 77ºF).

KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN.

TEVA PHARMACEUTICALS USA, INC.

North Wales, PA 19454

Rev. A 3/2016

NDC 0555-0483-02

BP-Loride (Amiloride Hydrochloride)

Hydrochloride and

Hydrochlorothiazide

Tablets USP

5 mg/50 mg

Rx only

100 TABLETS

TEVA

Atenolol:


Pharmacological action

BP-Loride is a cardioselective beta1-blocker without intrinsic sympathomimetic activity. This medication has antihypertensive, antianginal and antiarrhythmic action. BP-Loride (Atenolol) reduces the stimulatory effect on the heart sympathetic innervation and circulating catecholamines.

The hypotensive effect of this drug is associated with a decrease in minute volume of blood, decreased activity of the renin-angiotensin system (has a greater significance for patients with initial hypersecretion of renin), sensitivity of baroreceptors of the aortic arch (not going to enhance their activity in response to decreased blood pressure) and the effect on the CNS; manifested lower both systolic and diastolic blood pressure, decreasing stroke volume and cardiac output. In the medium therapeutic doses it has no effect on the tone of peripheral arteries.

The antianginal effect of BP-Loride (Atenolol) is associated with decreased myocardial oxygen demand by decreasing heart rate (lengthening of diastole and improved myocardial perfusion) and contractility, as well as reduced sensitivity to the effects of myocardial sympathetic innervation. Decrease in heart rate occurs at rest and during exercise.

The antiarrhythmic effect of this medicine is due to the elimination of arrhythmogenic factors (tachycardia, increased activity of the sympathetic nervous system, increase of cAMP, hypertension), decrease in the rate of spontaneous excitation of the sinus and ectopic pacemakers and slowing of AV conduction.

The hypotensive effect lasts 24 hours, with regular admission is stabilized by the end of 2 weeks of treatment. The negative chronotropic effect is manifested by 1 h after administration, reaches a maximum after in 2-4 hours and lasts up to 24 hours.

Pharmacokinetics

After oral administration the absorption of BP-Loride (Atenolol) from the gastrointestinal tract is 50-60%, its bioavailability is 40-50%. This drug is practically not metabolized in the body; poorly penetrates the BBB. The plasma protein binding is 6-16%. T1/2 is 6-9 h. BP-Loride (Atenolol) is primarily excreted by the kidneys in unchanged form. Renal dysfunction accompanied mainly to the increase of T1/2 and cumulation. This medication is excreted during hemodialysis. For elderly patients T1/2 of BP-Loride (Atenolol) is increased.

Why is BP-Loride prescribed?

Hypertension, hypertensive crisis, mitral valve prolapse, cardiac hyperkinetic syndrome of functional origin, neurocirculatory dystonia of hypertensive type.

Treatment: coronary artery disease, angina pectoris (stress, rest and unstable).

Treatment and prevention of: myocardial infarction (acute phase in stable hemodynamic parameters, secondary prevention).

Arrhythmias (including at the general anesthesia, congenital syndrome prolongation QT, myocardial infarction without signs of congestive heart failure, thyrotoxicosis), sinus tachycardia, paroxysmal atrial tachycardia, supraventricular and ventricular premature beats, supraventricular and ventricular tachycardia, atrial tachyarrhythmia, atrial flutter.

Essential and senile tremor, agitation and tremors withdrawal syndrome.

In the combined therapy: hypertrophic obstructive cardiomyopathy, pheochromocytoma (only in combination with alpha-blockers), hyperthyroidism; migraine (prophylaxis).

Dosage and administration

The dosing regimen of BP-Loride is set individually. The usual dose for adults for oral administration at the beginning of treatment is 25-50 mg 1 time / day. If necessary the dose is increased gradually. If impaired renal function in patients with CC 15-35 ml / min - 50 mg / day; with CC less than 15 ml / min - 50 mg every other day.

The maximum dose for adults for oral administration is 200 mg / day in 1 or 2 doses.

BP-Loride (Atenolol) side effects, adverse reactions

Cardiovascular system: in some cases - bradycardia, hypotension, AV-conduction disturbances, symptoms of heart failure.

Digestive system: at the beginning of therapy it is possible nausea, constipation, diarrhea, dry mouth.

CNS and peripheral nervous system: at the beginning of therapy may be fatigue, dizziness, depression, mild headache, sleep disturbances, coldness and paresthesia in extremities, reduced reactivity of the patient, reducing the secretion of tear fluid, conjunctivitis.

Endocrine system: reduced potency, hypoglycemic state in patients with diabetes.

Respiratory system: in predisposed patients - symptoms of bronchial obstruction.

Allergic reactions: itching.

Other: increased sweating, redness of the skin.

BP-Loride contraindications

AV-block II and III degree, sinoatrial block, SSS, bradycardia (HR < 40 bpm), hypotension (in case of myocardial infarction, systolic blood pressure less than 100 mm Hg), cardiogenic shock, congestive heart failure IIB-III stages, acute heart failure, Prinzmetal's angina, lactation, concomitant use of MAO inhibitors, hypersensitivity to BP-Loride (Atenolol).

Using during pregnancy and breastfeeding

BP-Loride crosses the placental barrier, so use during pregnancy is only possible if the intended benefits to the mother justifies potential risk to the fetus.

BP-Loride (Atenolol) is excreted in breast milk, so if you need to use during lactation is recommended to stop breastfeeding.

Category effects on the fetus by FDA - D.

Special instructions

With caution use this medication in hepatic failure.

BP-Loride (Atenolol) should be used with caution in diabetes, COPD (including asthma, emphysema), metabolic acidosis, hypoglycemia, allergic reactions, a history of chronic heart failure (compensated), obliterating peripheral arterial disease (intermittent claudication, Raynaud's syndrome), pheochromocytoma, liver failure, chronic renal insufficiency, myasthenia gravis, hyperthyroidism, depression (including in history), psoriasis, pregnancy, elderly patients, in pediatrics (the efficacy and safety are not defined).

While taking BP-Loride (Atenolol) it can decrease tear fluid production, which is important for patients who use contact lenses.

Cancellation of this drug after prolonged treatment should be carried out gradually under medical supervision.

Upon the termination of the combined use of BP-Loride (Atenolol) and clonidine, clonidine treatment continued for several days after discontinuation of BP-Loride (Atenolol), otherwise you may experience severe arterial hypertension.

When the need for inhaled anesthesia in patients receiving BP-Loride (Atenolol) Meliapharm, a few days before anesthesia to stop taking BP-Loride (Atenolol) or find a medication for anesthesia with minimal negative inotropic effects.

Patients whose work requires high concentration, the question of outpatient use of BP-Loride (Atenolol) should be addressed only after an assessment of individual response.

BP-Loride drug interactions

Antiarrhythmic and anesthetic facilities increase cardiodepressive action of this drug (increased risk of developing bradycardia, arrhythmia, hypotension, heart failure).

Reserpine, methyldopa, clonidine, guanfacine, cardiac glycosides potentiate the negative chrono-, drome- and bathmotropic effect, insulin and other antidiabetic funds - hypoglycemia.

NSAIDs, estrogens, sympathomimetics, xanthines weaken the anti-hypertensive effect, absorption; sympatholytic, nitroglycerin, hydralazine, and other antihypertensive drugs increase it; antacids slow down this medication absorption.

Cimetidine inhibits the metabolism of BP-Loride (Atenolol) Meliapharm.

This medication prolongs the action of anti-depolarizing muscle relaxant, anticoagulant effect of coumarins.

Three / tetracyclic antidepressants, antipsychotics, sedatives, hypnotics and alcohol potentiate CNS depression.

BP-Loride (Atenolol) is incompatible with MAO inhibitors.

BP-Loride in case of emergency / overdose

Symptoms: bradycardia, AV block II-III degree, heart failure, respiratory failure, hypotension, bronchospasm, hypoglycemia.

Treatment: gastric lavage and the appointment of adsorbing medications; Symptomatic treatment: atropine, isoprenaline, orciprenaline, cardiac glycosides or glucagon, diuretics, pressor agents (dopamine, dobutamine or norepinephrine), selective beta-adrenoceptor agonists, IV glucose solution, installation of an artificial pacemaker. Perhaps dialysis.

Hydrochlorothiazide:


BP-Loride information

BP-Loride (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.

BP-Loride indications

BP-Loride (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. BP-Loride (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.

BP-Loride warnings

BP-Loride (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 BP-Loride (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 BP-Loride (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.

BP-Loride intake guidelines

You should always take BP-Loride (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.

BP-Loride dosage

The exact BP-Loride (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 BP-Loride (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 BP-Loride (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.

BP-Loride overdose

You should never exceed the BP-Loride (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 BP-Loride (Hydrochlorothiazide) are dehydration and cardiac arrhythmia. The patient may also suffer from electrolyte depletion and thus may present the relevant signs and symptoms.

BP-Loride missed dose

In case you have missed a dose of BP-Loride (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 BP-Loride (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.

BP-Loride side effects

In some patients BP-Loride (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.

BP-Loride drug reactions

BP-Loride (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 BP-Loride (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 BP-Loride (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.

BP-Loride pharmaceutical active ingredients containing related brand and generic drugs:

Active 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.


BP-Loride available forms, composition, doses:

Form 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.


BP-Loride destination | category:

Destination 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.


BP-Loride Anatomical Therapeutic Chemical codes:

A 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.


BP-Loride pharmaceutical companies:

Pharmaceutical 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."AMILORIDE HYDROCHLORIDE TABLET [PAR PHARMACEUTICAL INC.]". https://dailymed.nlm.nih.gov/dailym... (accessed August 28, 2018).
  2. Dailymed."HYDROCHLOROTHIAZIDE TABLET [QUALITEST PHARMACEUTICALS]". https://dailymed.nlm.nih.gov/dailym... (accessed August 28, 2018).
  3. Dailymed."ATENOLOL TABLET [LAKE ERIE MEDICAL & SURGICAL SUPPLY DBA QUALITY CARE PRODUCTS LLC]". https://dailymed.nlm.nih.gov/dailym... (accessed August 28, 2018).

Frequently asked Questions

Can i drive or operate heavy machine after consuming BP-Loride?

Depending on the reaction of the BP-Loride after taken, if you are feeling dizziness, drowsiness or any weakness as a reaction on your body, Then consider BP-Loride 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 BP-Loride 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 BP-Loride, 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 BP-Loride 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. Rachana Salvi, MD Pharmacology

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