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GREENSTONE LLC INTRODUCES NADOLOL TABLETS
Authorized Generic of Corgard®

PEAPACK, N.J., May 2014 — Greenstone LLC, a U.S.-based subsidiary of Pfizer Inc. (NYSE: PFE), is pleased to announce the introduction of Nadolol tablets to its ever-expanding generic pharmaceutical product line. The product is offered in dosage strengths of 20 mg x 100; 40 mg x 100 and 80 mg x 100.

Greenstone’s Nadolol tablets product is the authorized generic of, and equivalent to the innovator’s product, CORGARD® (nadolol). This new authorized generic adds to Greenstone’s consistently growing line of products, and is backed by the distribution and customer service support of Pfizer Inc., one of the world’s largest pharmaceutical companies. As a subsidiary of Pfizer, Greenstone operates under the same values and commitment to bring quality authorized generics to customers, payers, and the patients it serves.

See the Full Prescribing Information, including boxed warning, for Greenstone’s Nadolol tablets at http://www.greenstonellc.com/product-list.aspx. For more information about Greenstone LLC and its products, visit http://greenstonellc.com.

INDICATION
Nadolol tablet is indicated for the long-term management of patients with angina pectoris and for the treatment of hypertension, to lower blood pressure.

IMPORTANT SAFETY INFORMATION
WARNING
Exacerbation of Ischemic Heart Disease Following Abrupt Withdrawal—Hypersensitivity to catecholamines has been observed in patients withdrawn from beta-blocker therapy; exacerbation of angina and, in some cases, myocardial infarction have occurred after abrupt discontinuation of such therapy. When discontinuing chronically administered nadolol, particularly in patients with ischemic heart disease, the dosage should be gradually reduced over a period of one to two weeks and the patient should be carefully monitored. If angina markedly worsens or acute coronary insufficiency develops, nadolol administration should be reinstituted promptly, at least temporarily, and other measures appropriate for the management of unstable angina should be taken. Patients should be warned against interruption or discontinuation of therapy without the physician’s advice. Because coronary artery disease is common and may be unrecognized, it may be prudent not to discontinue nadolol therapy abruptly even in patients treated only for hypertension.

Nadolol is contraindicated in bronchial asthma, sinus bradycardia and greater than first degree conduction block, cardiogenic shock, and overt 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, if necessary, they can be used with caution in patients with a history of failure who are well-compensated.
IN PATIENTS WITHOUT A HISTORY OF HEART FAILURE, continued use of beta-blockers can, in some cases, lead to cardiac failure. Therefore, at the first sign or symptom of heart failure, the patient should be digitalized and/or treated with diuretics, and the response observed closely, or nadolol should be discontinued (gradually, if possible).
Nonallergic Bronchospasm - PATIENTS WITH BRONCHOSPASTIC DISEASES SHOULD IN GENERAL NOT RECEIVE BETA-BLOCKERS.
Major Surgery - Chronically administered beta-blocking therapy should not be routinely withdrawn prior to major surgery; however, the impaired ability of the heart to respond to reflex adrenergic stimuli may augment the risks of general anesthesia and surgical procedures.
Diabetes and Hypoglycemia - Beta-adrenergic blockade may prevent the appearance of premonitory signs and symptoms of acute hypoglycemia. This is especially important with labile diabetics. Beta-blockade also reduces the release of insulin in response to hyperglycemia; therefore, it may be necessary to adjust the dose of antidiabetic drugs.
Thyrotoxicosis - Beta-adrenergic blockade may mask certain clinical signs of hyperthyroidism. Patients suspected of developing thyrotoxicosis should be managed carefully.

Nadolol should be used with caution in patients with impaired renal function.
When administered concurrently, the following drugs may interact with beta adrenergic receptor blocking agents: Anesthetics, general, Antidiabetic drugs, Catecholamine-depleting drugs (e.g., reserpine), Digitalis glycosides.
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.
Pregnancy Category C Nadolol should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Nadolol is excreted in human milk. Because of the potential for adverse effects in nursing infants, a decision should be made whether to discontinue nursing or to discontinue therapy taking into account the importance of nadolol to the mother.
Safety and effectiveness in pediatric patients have not been established.

In patients taking Nadolol:
Bradycardia occurs commonly. Symptoms of peripheral vascular insufficiency, usually of the Raynaud type, have occurred. Cardiac failure, hypotension, and rhythm/conduction disturbances have each occurred. First degree, third degree heart block, dizziness, fatigue, paresthesias, sedation, change in behavior, bronchospasm, nausea, diarrhea, abdominal discomfort, constipations, vomiting, indigestion, anorexia, bloating and flatulence have been reported.
The following have also been reported: rash; pruritus; headache; dry mouth, eyes, or skin; impotence or decreased libido; facial swelling; weight gain; slurred speech; cough; nasal stuffiness; sweating; tinnitus; blurred vision. Reversible alopecia has been reported infrequently.
The following adverse reactions have been reported in patients taking Nadolol and/or other beta adrenergic blocking agents, but no causal relationship to nadolol has been established: reversible mental depression progressing to catatonia; visual disturbances; hallucinations; an acute reversible syndrome characterized by disorientation for time and place, short-term memory loss, emotional lability with slightly clouded sensorium, and decreased performance on neuropsychometrics. Mesenteric arterial thrombosis; ischemic colitis; elevated liver enzymes.
Agranulocytosis; thrombocytopenic or nonthrombocytopenic purpura. Fever combined with aching and sore throat; laryngospasm; respiratory distress. Pemphigoid rash; hypertensive reaction in patients with pheochromocytoma; sleep disturbances; Peyronie's disease.