ACYCLOVIR CAPSULES USP ACYCLOVIR TABLETS USP 8940 8943 8947 Rx only

DESCRIPTION

DESCRIPTION SECTION

Acyclovir is a synthetic nucleoside analogue active against herpesviruses. Each capsule, for oral administration, contains 200 mg of acyclovir. In addition, each capsule contains the following inactive ingredients: corn starch, lactose monohydrate, magnesium stearate and sodium lauryl sulfate. The capsule shell consists of gelatin, FD&C blue No. 1, D&C red No. 28, D&C red No. 33 and titanium dioxide. Printed with edible black ink that contains FD&C blue No. 1, FD&C blue No. 2, FD&C red No. 40 and D&C yellow No. 10. Each tablet, for oral administration, contains 400 mg or 800 mg of acyclovir. In addition, each tablet contains the following inactive ingredients: colloidal silicon dioxide, lactose monohydrate, magnesium stearate, microcrystalline cellulose, povidone, pregelatinized starch and sodium starch glycolate. The 400 mg tablets also contain FD&C blue No. 2. Acyclovir is a white to off-white, crystalline powder. The maximum solubility in water at 37°C is 2.5 mg/mL. The pka’s of acyclovir are 2.27 and 9.25. The chemical name of acyclovir is 2-amino-1,9-dihydro-9-[(2-hydroxyethoxy)methyl]-6 H- purin-6-one; it has the following structural formula: C 8 H 11 N 5 O 3 M.W. 225

VIROLOGY

SPL UNCLASSIFIED SECTION

CLINICAL PHARMACOLOGY

CLINICAL PHARMACOLOGY SECTION

INDICATIONS AND USAGE

INDICATIONS & USAGE SECTION

CONTRAINDICATIONS

CONTRAINDICATIONS SECTION

Acyclovir is contraindicated for patients who develop hypersensitivity to acyclovir or valacyclovir.

WARNINGS

WARNINGS SECTION

Acyclovir capsules and tablets are intended for oral ingestion only. Renal failure, in some cases resulting in death, has been observed with acyclovir therapy (see ADVERSE REACTIONS , Observed During Clinical Practice and OVERDOSAGE ). Thrombotic thrombocytopenic purpura/hemolytic uremic syndrome (TTP/HUS), which has resulted in death, has occurred in immunocompromised patients receiving acyclovir therapy.

PRECAUTIONS

PRECAUTIONS SECTION

Dosage adjustment is recommended when administering acyclovir to patients with renal impairment (see DOSAGE AND ADMINISTRATION ). Caution should also be exercised when administering acyclovir to patients receiving potentially nephrotoxic agents since this may increase the risk of renal dysfunction and/or the risk of reversible central nervous system symptoms such as those that have been reported in patients treated with intravenous acyclovir. Adequate hydration should be maintained.

ADVERSE REACTIONS

ADVERSE REACTIONS SECTION

OVERDOSAGE

OVERDOSAGE SECTION

Overdoses involving ingestion of up to 100 capsules (20 g) have been reported. Adverse events that have been reported in association with overdosage include agitation, coma, seizures, and lethargy. Precipitation of acyclovir in renal tubules may occur when the solubility (2.5 mg/mL) is exceeded in the intratubular fluid. Overdosage has been reported following bolus injections or inappropriately high doses and in patients whose fluid and electrolyte balance were not properly monitored. This has resulted in elevated BUN and serum creatinine and subsequent renal failure. In the event of acute renal failure and anuria, the patient may benefit from hemodialysis until renal function is restored (see DOSAGE AND ADMINISTRATION ).

DOSAGE AND ADMINISTRATION

DOSAGE & ADMINISTRATION SECTION

HOW SUPPLIED

HOW SUPPLIED SECTION

Acyclovir capsules USP are available containing 200 mg acyclovir. Each opaque blue cap and body size #1 hard gelatin capsule is imprinted with black ink N 940 and 200 on opposing cap and body portion of the capsule. They are supplied as follows: NDC 33261-419-30 Bottles of 30 Acyclovir tablets USP are available containing 400 mg acyclovir. Each blue colored, biconvex, capsule shaped, compressed unscored tablet is debossed with N 943 on one side and 400 on the other side. They are supplied as follows: NDC 33261-491-21 Bottles of 21 NDC 33261-491-25 Bottles of 25 NDC 33261-491-28 Bottles of 28 NDC 33261-491-30 Bottles of 30 NDC 33261-491-60 Bottles of 60 NDC 33261-491-90 Bottles of 90 Acyclovir tablets USP are available containing 800 mg acyclovir. Each white to off-white colored, biconvex, capsule shaped, compressed unscored tablet is debossed with N 947 on one side and 800 on the other side. They are supplied as follows: NDC 33261-227-16 Bottles of 30 NDC 33261-227-30 Bottles of 30 NDC 33261-227-35 Bottles of 30 NDC 33261-227-40 Bottles of 30 Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Protect from light and moisture. Manufactured In Canada By: NOVOPHARM LIMITED Toronto, Canada M1B 2K9 Manufactured For: TEVA PHARMACEUTICALS USA Sellersville, PA 18960 Repackaged By: Aidarex Pharmaceuticals, LLC. Corona, CA 92880 Rev. F 9/2008

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