was determined [1:<1 Special Senses Abnormal Vision 2 2 3 0 The following selected (potentially important) side effects were seen in up to 2% of Sectral patients: Cardiovascular: hypotension, bradycardia, heart failure. Central Nervous System: anxiety, hyper/hypoesthesia, impotence. Dermatological: pruritus. Gastrointestinal: vomiting, abdominal pain. Genitourinary: dysuria, nocturia. Liver and Biliary System: A small number of cases of liver abnormalities (increased SGOT, SGPT, LDH) have been reported in association with acebutolol therapy. In some cases increased bilirubin or alkaline phosphatase, fever, malaise, dark urine, anorexia, nausea, headache, and/or other symptoms have been reported. In some of the reported cases, the symptoms and signs were confirmed by rechallenge with acebutolol. The abnormalities were reversible upon cessation of acebutolol therapy. Musculoskeletal: back pain, joint pain. Respiratory: pharyngitis, wheezing. Special Senses: conjunctivitis, dry eye, eye pain. Autoimmune: In extremely rare instances, systemic lupus erythematosus has been reported. The incidence of drug-related adverse effects (volunteered and solicited) according to Sectral dose is shown below. (Data from 266 hypertensive patients treated for 3 months on a constant dose.) Body System 400 mg/day (N=132) 800 mg/day (N=63) 1200 mg/day (N=71) Cardiovascular 5% 2% 1% Gastrointestinal 3% 3% 7% Musculoskeletal 2% 3% 4% Central Nervous System 9% 13% 17% Respiratory 1% 5% 6% Skin 1% 2% 1% Special Senses 2% 2% 6% Genitourinary 2% 3% 1% Potential Adverse Events In addition, certain adverse effects not listed above have been reported with other β-blocking agents and should also be considered as potential adverse effects of Sectral. Central Nervous System : Reversible mental depression progressing to catatonia (an acute syndrome characterized by disorientation for time and place), short-term memory loss, emotional lability, slightly clouded sensorium, and decreased performance (neuropsychometrics). Cardiovascula r: Intensification of AV block (see CONTRAINDICATIONS ). Allergic: Erythematous rash, fever combined with aching and sore throat, laryngospasm, and respiratory distress. Hematologic: Agranulocytosis, nonthrombocytopenic, and thrombocytopenic purpura. Gastrointestinal: Mesenteric arterial thrombosis and ischemic colitis. Miscellaneous: Reversible alopecia and Peyronie s disease. The oculomucocutaneous syndrome associated with the β-blocker practolol has not been reported with Sectral during investigational use and extensive foreign clinical experience. Overdosage No specific information on emergency treatment of overdosage is available for Sectral. However, overdosage with other β-blocking agents has been accompanied by extreme bradycardia, advanced atrioventricular block, intraventricular conduction defects, hypotension, severe congestive heart failure, seizures, and in susceptible patients, bronchospasm and hypoglycemia. Although specific information on the emergency treatment of Sectral overdose is not available, on the basis of the pharmacological actions and the observations in treating overdoses with other β-blockers, the following general measures should be considered: Empty stomach by emesis or lavage. Bradycardia: IV atropine (1 to 3 mg in divided doses). If antivagal response is inadequate, administer isoproterenol cautiously since larger than usual doses of isoproterenol may be required. Persistent hypotension in spite of correction of bradycardia: Administer vasopressor (e.g., epinephrine, levarterenol, dopamine, or dobutamine) with frequent monitoring of blood pressure and pulse rate. Bronchospasm: A theophylline derivative, such as aminophylline and/or parenteral β 2 -stimulant, such as terbutaline. Cardiac failure: Digitalize the patient and/or administer a diuretic. It has been reported that glucagon is useful in this situation. Sectral is dialyzable. Sectral Dosage and Administration Hypertension The initial dosage of Sectral in uncomplicated mild-to-moderate hypertension is 400 mg. This can be given as a single daily dose, but in occasional patients twice daily dosing may be required for adequate 24-hour blood-pressure control. An optimal response is usually achieved with dosages of 400 to 800 mg per day, although some patients have been maintained on as little as 200 mg per day. Patients with more severe hypertension or who have demonstrated inadequate control may respond to a total of 1200 mg daily (administered b.i.d.), or to the addition of a second antihypertensive agent. Beta-1 selectivity diminishes as dosage is increased. Ventricular Arrhythmia The usual initial dose of Sectral is 400 mg daily given as 200 mg b.i.d. Dosage should be increased gradually until an optimal clinical response is obtained, generally at 600 to 1200 mg per day. If treatment is to be discontinued, the dosage should be reduced gradually over a period of about two weeks. Use in Older Patients Older patients have an approximately 2-fold increase in bioavailability and may require lower maintenance doses. Doses above 800 mg/day should be avoided in the elderly. How is Sectral Supplied Sectral (acebutolol HCl) is available in the following dosage strengths: 200 mg, opaque purple and orange capsule marked "RP 700" and "Sectral 200" NDC 67857-700-01, in bottles of 100 capsules. 400 mg, opaque brown and orange capsule marked "RP 701" and "Sectral 400" NDC 67857-701-01, in bottles of 100 capsules. Keep tightly closed Store at controlled room temperature 20 to 25 C (68 to 77 F) Protect from light Dispense in a light-resistant, tight container Use carton to protect contents from light Distributed by: Promius Pharma, LLC Bridgewater, NJ 08807 Manufactured by: PATHEON, Puerto Rico, Inc. Manatí, Puerto Rico 00674, USA Revised April 2008 PRINCIPAL DISPLAY PANEL NDC-67857-700-01 100 Capsules Sectral (acebutolol HCL) equivalent to 200 mg acebutolol SEALED FOR YOUR PROTECTION Rx only PROMIUS PHARMA Sectral acebutolol hydrochloride capsule Product Information Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:67857-700 Route of Administration ORAL DEA Schedule Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ACEBUTOLOL HYDROCHLORIDE (ACEBUTOLOL) ACEBUTOLOL 200 mg Inactive Ingredients Ingredient Name Strength D&C Red No. 22 FD&C Blue No. 1 FD&C Yellow No. 6 D&C Red No. 28 gelatin povidone starch, corn stearic acid titanium dioxide Product Characteristics Color PURPLE (Purple) , ORANGE (Orange) Score no score Shape CAPSULE Size 18mm Flavor Imprint Code RP;700;Sectral;200 Contains Packaging # Item Code Package Description 1 NDC:67857-700-01 100 CAPSULE (CAPSULE) in 1 BOTTLE, PLASTIC Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date NDA NDA018917 12/28/1984 Sectral acebutolol hydrochloride capsule Product Information Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:67857-701 Route of Administration ORAL DEA Schedule Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ACEBUTOLOL HYDROCHLORIDE (ACEBUTOLOL) ACEBUTOLOL 400 mg Inactive Ingredients Ingredient Name Strength D&C Red No. 22 FD&C Blue No. 1 FD&C Yellow No. 6 FD&C Red No. 40 gelatin povidone starch, corn stearic acid titanium dioxide Product Characteristics Color BROWN (Brown) , ORANGE (Orange) Score no score Shape CAPSULE Size 24mm Flavor Imprint Code RP;700;Sectral;400 Contains Packaging # Item Code Package Description 1 NDC:67857-701-01 100 CAPSULE (CAPSULE) in 1 BOTTLE, PLASTIC Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date NDA NDA018917 12/28/1984 Labeler - Promius Pharma, LLC (020408265) Registrant - Promius Pharma, LLC (020408265) Establishment Name Address ID/FEI Operations Patheon Puerto Rico, Inc. 143814544 manufacture(67857-700, 67857-701) Revised: 01/2012 Promius Pharma, LLC Next Interactions Print this page Add to My Med List More about Sectral (acebutolol) Side Effects During Pregnancy or Breastfeeding Dosage Information Drug Images Drug Interactions Support Group En Español 2 Reviews Add your own review/rating Generic Availability Drug class: cardioselective beta blockers Consumer resources Sectral Sectral (Advanced Reading) Professional resources Sectral (AHFS Monograph) Acebutolol (FDA) Related treatment guides High Blood Pressure Premature Ventricular Depolarizations Ventricular Arrhythmia> ]} FEATURED: CAR-T Cell Therapy Overview Mechanism of Action KTE-C19 Studies KTE-C19 Cancer Targets Adverse Events Manufacturing Drug Status Rx Availability Prescription only B Pregnancy Category No proven risk in humans N/A CSA Schedule Not a controlled drug 10 + years Approval History FDA approved 1984 WADA Class Anti-Doping Classification Drug Class Cardioselective beta blockers Group II antiarrhythmics Related Drugs cardioselective beta blockers metoprolol , atenolol , Toprol-XL , Bystolic group II antiarrhythmics propranolol , Inderal , acebutolol , Inderal LA , esmolol , InnoPran XL High Blood Pressure amlodipine , lisinopril , hydrochlorothiazide , furosemide , losartan , metoprolol , atenolol , More... Premature Ventricular Depolarizations bisoprolol , Zebeta , acebutolol , More... Ventricular Arrhythmia sotalol , magnesium sulfate , acebutolol , Betapace , Epsom Salt , Sorine , More... Sectral Rating 2 User Reviews 9.5 /10 2 User Reviews 9.5 Rate it! Sectral Images Sectral 200 MG (SECTRAL 200 WYETH 4177) View all images} } customise
registration number plate Sectral by the way
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