Manufactured for Sciele Pharma, Inc., Atlanta, Georgia 30328 by G. Pohl-Boskamp GmbH & Co. KG, D-25551 Hohenlockstedt, Germany

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Nitrolingual Pumpspray – Effective Treatment for Angina Pectoris

If you suffer from angina pectoris (chest pain associated with coronary artery disease), Nitrolingual Pumpspray can offer you safe, effective treatment.

Rapid pain relief¹

69% (p<0.001) of patients report pain relief within 60 seconds

Potent, stable and reliable for up to 24 months

24-month shelf-life from date of manufacture helps ensure medication works when you need it
Unlike tablets, no loss of potency due to light, moisture, or handling². For most sublingual nitroglycerin tablets, the shelf-life is only six months after the original amber bottle is opened
Clinical studies have verified that sublingual nitroglycerin tablets have stability problems and lose their potency, particularly if not properly stored.³ Furthermore, tablets carried by patients often have diminished activity⁴

Low incidence of headache⁵

More patients reported no headache (58% vs. 39% taking nitroglycerin tablets)

Simple and reliable administration¹

One spray on or under the tongue provides a metered 0.4 mg dose

WARNING: Amplification of the vasodilatory effects of Nitrolingual Pumpspray by certain drugs (phosphodiesterase inhibitors) used to treat erectile dysfunction can result in severe hypotension. The time course and dose dependence of this interaction have not been studied. Appropriate supportive care has not been studied, but it seems reasonable to treat this as a nitrate overdose, with elevation of the extremities and with central volume expansion. The use of any form of nitroglycerin during the early days of acute myocardial infarction requires particular attention to hemodynamic monitoring and clinical status.

Indications and Usage: Nitrolingual Pumpspray is indicated for acute relief of an attack or prophylaxis of angina pectoris due to coronary artery disease.

Important Safety Information: Nitrolingual Pumpspray should not be used while taking phosphodiesterase inhibitors which are used for the treatment of erectile dysfunction. Nitrolingual Pumpspray should be used with caution if patients have low systolic blood pressure, are undergoing diuretic therapy, or show hypersensitivity to this and other nitrates or nitrites. Headache is the most commonly reported side effect with nitroglycerin. Patients may also experience episodes of dizziness, weakness, and other related side effects.

Safety and effectiveness of nitroglycerin in pediatric patients has not been established.

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You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.FDA.gov/medwatch or call 1-800-FDA-1088

References: 1. Vandenburg MJ, Wright LJ, Griffiths GK et al. Sublingual nitroglycerin or spray in the treatment of angina. Br J Clin Pract. 1986; 40: 524-527. 2. Data on file. Sciele Pharma, Inc. 3. Page DP, Carson NA, Buhr CA, et al. Stability study of nitroglycerin sublingual tablets. J Pharm Sci. 1975; 64: 140-147. 4. Marty J. Shaw J. Hunt D. The stability of glyceryl trinitrate tablets during patient use. Aust NZ J Med. 1983; 13: 147-150. 5: O'Hanrahan,M, et al. Diminished activity of glyceryl trinitrate. Br Med J 1982; 284:1183-1184

Nitrolingual is a registered trademark of G. Pohl-Boskamp GMBH & Co. Sciele's use of Nitrolingual is under license from G. Pohl-Boskamp GMBH & Co.

This web site and its contents are intended for use only by residents of the United States. Products discussed may have different labeling, regulatory requirements, and/or medical practices in other countries that may require reference to different or additional information.