Source:http://www4.wiwiss.fu-berlin.de/dailymed/resource/drugs/2651
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InnoPran XL (Capsule, Extended Release)
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InnoPran XL should be administered once daily at bedtime (approximately 10 PM) and should be taken consistently either on an empty stomach or with food. The starting dose is 80 mg but dosage should be individualized and titration may be needed to a dose of 120 mg. In the clinical trial, doses of InnoPran XL above 120 mg had no additional effects on blood pressure (See PHARMACODYNAMICS AND CLINICAL EFFECTS). The time needed for full antihypertensive response is variable, but is usually achieved within 2-3 weeks.
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| dailymed-instance:descripti... |
InnoPran XL (propranolol hydrochloride) is a nonselective, beta-adrenergic receptor-blocking agent for oral administration, available as an extended release product. InnoPran XL is available as 80 mg and 120 mg capsules which contain sustained-release beads. Each of the beads contains propranolol hydrochloride and is coated with dual membranes. These membranes are designed to retard release of propranolol hydrochloride for several hours after ingestion followed by the sustained release of propranolol. The active ingredient in InnoPran XL is a synthetic beta-adrenergic receptor-blocking agent chemically described as 1-(Isopropylamino)-3-(1-naphthyloxy)-2-propanol hydrochloride. Its structural formula is: Propranolol hydrochloride is a stable, white, crystalline solid, which is readily soluble in water and ethanol. Its molecular weight is 295.81. Each capsule for oral administration contains sugar spheres, ethylcellulose, povidone, hypromellose phthalate, diethyl pthalate, hypromellose, polyethylene glycol, gelatin, titanium dioxide and black iron oxide. In addition, InnoPran XL 120-mg capsules contain yellowiron oxide.
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General: Propranolol 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-receptor sites is blocked by propranolol, chronotropic, inotropic, and vasodilator responses to beta-adrenergic stimulation are decreased proportionately. At dosages greater than required for beta blockade, propranolol 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.<br/>Mechanism of Action: The mechanism of the antihypertensive effect of propranolol has not been established. Among factors that contribute to the antihypertensive action are: (1) decreased cardiac output, (2) inhibition of renin release by the kidneys, and (3) diminution of tonic sympathetic nerve outflow from vasomotor centers in the brain. Although total peripheral resistance may increase initially, it readjusts to or below the pretreatment level with chronic use of propranolol. Effects of propranolol on plasma volume appear to be minor and somewhat variable.
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Propranolol 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 hydrochloride.
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InnoPran XL (propranolol hydrochloride) Extended Release Capsules Each gray/white capsule, imprinted with���80���, 2 segmented bands,���InnoPran XL���, and Reliant logo contains 80 mg of propranolol hydrochloride in bottles of 30 (NDC 65726-250-10), bottles of 100 (NDC 65726-250-25), bottles of 500 (NDC 65726-250-35), and a Unit Dose package of 100 (NDC 65726-250-90). Each gray/off-white capsule, imprinted with���120���, 3 segmented bands,���InnoPran XL���, and Reliant logo contains 120 mg of propranolol hydrochloride in bottles of 30 (NDC 65726-251-10) bottles of 100 (NDC 65726-251-25), bottles of 500 (NDC 65726-251-35), and a Unit Dose package of 100 (NDC 65726-251-90). Store at 25��C (77��F); excursions permitted to 15 - 30��C (59 - 86��F) [see USP Controlled Room Temperature] in a tightly closed container. The unit dose packaging should be stored in the carton. Rx only January, 2005 Manufactured for: Reliant Pharmaceuticals, Inc. Liberty Corner, NJ 07938, USA By: Eurand America, Inc. Vandalia, OH 45377, USA Address Medical Inquiries to: Reliant Pharmaceuticals, Inc. Medical Affairs 110 Allen Road Liberty Corner, NJ 07938, USA ��2005 Reliant Pharmaceuticals, Inc. PRINTED IN USA 225F004
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Angina Pectoris: There have been reports of exacerbation of angina and, in some cases, myocardial infarction, following abrupt discontinuance of propranolol therapy. Therefore, when discontinuance of propranolol 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 therapy is interrupted and exacerbation of angina occurs, it is usually advisable to reinstitute propranolol therapy and take other measures appropriatefor 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 for other indications.
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dailymed-ingredient:black_iron_oxide,
dailymed-ingredient:diethyl_pthalate,
dailymed-ingredient:ethylcellulose,
dailymed-ingredient:gelatin,
dailymed-ingredient:hypromellose,
dailymed-ingredient:hypromellose_phthalate,
dailymed-ingredient:polyethylene_glycol,
dailymed-ingredient:povidone,
dailymed-ingredient:sugar_spheres,
dailymed-ingredient:titanium_dioxide
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| dailymed-instance:precautio... |
General: Propranolol should be used with caution in patients with impaired hepatic or renal function. InnoPran XL is not indicated for the treatment of hypertensive emergencies. Beta-adrenergic receptor blockade can cause reduction of intraocular pressure. Patients should be told that InnoPran XL may interfere with the glaucoma screening test. Withdrawal may lead to a return of 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.<br/>Clinical Laboratory tests: In patients with hypertension, use of propranolol has been associated with elevated levels of serum potassium, and serum transaminases and alkaline phosphatase. In severe heart failure, the use of propranolol has been associated with increases in Blood Urea Nitrogen.<br/>Drug Interactions: Caution should be exercised when InnoPran XL is administered with drugs that have an effect on CYP2D6, 1A2 or 2C19 metabolic pathways. Co-administration of such drugs with propranolol may lead to clinically relevant drug interactions and changes on its efficacy and/or toxicity (see DRUG INTERACTIONS in CLINICAL PHARMACOLOGY).<br/>Cardiovascular Drugs:<br/>Non-Cardiovascular Drugs:<br/>Carcinogenesis, mutagenesis, impairment of fertility: In dietary administration studies in which mice and rats were treated with propranolol HCl 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 HCI. In a study in which both male and female rats were exposed to propranolol HCI 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 andlactation 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 HCI in bacteria (S. typhimurium strain TA 1538).<br/>Pregnancy: Pregnancy Category C: In a series of reproductive and developmental toxicology studies, propranolol 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 HCI 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 HCI during pregnancy. Neonates whose mothers received propranolol HCI at parturition have exhibited bradycardia, hypoglycemia, and respiratory depression. Adequate facilities for monitoring such infants at birth should be available. InnoPran XL should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.<br/>Nursing mothers: Propranolol is excreted in human milk. Caution should be exercised when InnoPran XL is administered to a nursing woman.<br/>Pediatric use: Safety and effectiveness of propranolol in pediatric patients have not been established.<br/>Geriatric use: Clinical studies of InnoPran XL did not include sufficient numbers of subjects ages 65 and over to determine whether they respond 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 of concomitant disease or other drug therapy.
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Most overdoses of propranolol are mild and respond to supportive care. Propranolol is not significantly dialyzable. In the event of overdose or exaggerated response, the following measures should be employed: Decontamination: Gastric lavage Supportive Therapy Hypotension and bradycardia have been reported following propranolol 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 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 used for bronchospasm.
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propranolol hydrochloride
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InnoPran XL (Capsule, Extended Release)
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Adverse events occurring at a rate of���3%, excluding those reported more commonly in placebo encountered in the InnoPran XL placebo-controlled hypertension trials and are plausibly related to treatment are shown in Table 1. The following adverse events were observed and have been reported with use of formulations of sustained- or immediate-release propranolol.<br/>Cardiovascular:: Bradycardia; congestive heart failure; intensification of AV block; hypotension; paresthesia of hands; thrombocytopenic purpura; arterial insufficiency, usually of the Raynaud type.<br/>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 decreased performance on neuropsychometrics. For immediate-release formulations, fatigue, lethargy, and vivid dreams appear doserelated.<br/>Gastrointestinal:: Nausea, vomiting, epigastric distress, abdominal cramping, diarrhea, constipation, mesenteric arterial thrombosis, ischemic colitis.<br/>Allergic:: Pharyngitis and agranulocytosis; erythematous rash, fever combined with aching and sore throat; laryngospasm, and respiratory distress.<br/>Respiratory:: Bronchospasm.<br/>Hematologic:: Agranulocytosis, nonthrombocytopenic purpura, thrombocytopenic purpura.<br/>Autoimmune:: In extremely rare instances, systemic lupus erythematosus has been reported.<br/>Miscellaneous:: Alopecia, LE-like reactions, psoriasiform 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.
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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 compensated and are receiving additional therapies, including diuretics as needed. Beta-adrenergic blocking agents do not abolish the inotropic action of digitalis on heart muscle. Angina Pectoris: There have been reports of exacerbation of angina and, in some cases, myocardial infarction, following abrupt discontinuance of propranolol therapy. Therefore, when discontinuance of propranolol 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 therapy is interrupted and exacerbation of angina occurs, it is usually advisable to reinstitute propranolol therapy and take other measures appropriatefor 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 for other indications.<br/>Nonallergic Bronchospasm (e.g., Chronic Bronchitis, Emphysema):: In general, patients with bronchospastic lung disease should not receive beta-blockers. Propranolol should be administered with caution in this setting since it may block bronchodilation produced by endogenous and exogenous catecholamine stimulation of beta-receptors.<br/>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 may augment the risks of general anesthesia and surgical procedures. 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. However, such patients may be subject to protracted severe hypotension.<br/>Diabetes and Hypoglycemia:: Beta-adrenergic blockade may prevent the appearance of certain premonitory signs and symptoms (pulse rate and blood 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 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 with propranolol use after prolonged physical exertion and in patients with renal insufficiency.<br/>Thyrotoxicosis:: Beta-adrenergic blockade may mask certain clinical signs of hyperthyroidism. Therefore, abrupt withdrawal of propranolol may be followed by an exacerbation of symptoms of hyperthyroidism, including thyroid storm. Propranolol may change thyroid-function tests, increasing Tand reversing T, and decreasing T.<br/>Wolff-Parkinson-White Syndrome:: Beta-adrenergic blockade in patients with Wolf���Parkinson-White syndrome and tachycardia has been associated with severe bradycardia requiring treatment with a pacemaker. In one case, this resulted after an initial dose of 5-mg propranolol.
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Hypertension: InnoPran XL is indicated in the management of hypertension; it may be used alone or in combination with other antihypertensive agents.
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InnoPran XL
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