Vancomycin Injection (Drug Description)

Vancomycin Injection, USP
in GALAXY Plastic Container (PL 2040)

For Intravenous Use Only

To reduce the development of drug-resistant bacteria and maintain the effectiveness of vancomycin and other antibacterial drugs, vancomycin should be used only to treat or prevent infections that are proven or strongly suspected to be caused by bacteria.

DRUG DESCRIPTION

Vancomycin Injection, USP in the GALAXY plastic container (PL 2040) contains vancomycin, added as Vancomycin Hydrochloride, USP. It is a tricyclic glycopeptide antibiotic derived from Amycolatopsis orientalis (formerly Nocardia orientalis). The molecular formula is C₆₆H₇₅C_l2N₉O₂₄•HCl and the molecular weight is 1,485.71. 500 mg of the base is equivalent to 0.34 mmol. Vancomycin hydrochloride has the following structural formula:

Vancomycin Injection, USP in the GALAXY plastic container (PL 2040) is a frozen, iso-osmotic, sterile, nonpyrogenic premixed 100 mL or 200 mL solution containing 500 mg or 1 g Vancomycin respectively as Vancomycin hydrochloride. Each 100 mL of solution contains approximately 5 g of Dextrose Hydrous, USP. The pH of the solution may have been adjusted with hydrochloric acid and/or sodium hydroxide. Thawed solutions have a pH in the range of 3.0 to 5.0. After thawing to room temperature, this solution is intended for intravenous use only.

This GALAXY container is fabricated from a specially designed multilayer plastic (PL 2040).

Solutions are in contact with the polyethylene layer of this container and can leach out certain chemical components of the plastic in very small amounts within the expiration period. The suitability of the plastic has been confirmed in tests in animals according to USP biological tests for plastic containers as well as by tissue culture toxicity studies.

Humulin N (Drug Description)

HUMULIN® N
(NPH HUMAN INSULIN (rDNA ORIGIN) ISOPHANE SUSPENSION, 10 mL Vial (1000 Units per vial), 100 UNITS PER ML (U-100))

Humulin is synthesized in a special non-disease-producing laboratory strain of Escherichia coli bacteria that has been genetically altered to produce human insulin. Humulin N [Human insulin (rDNA origin) isophane suspension] is a crystalline suspension of human insulin with protamine and zinc providing an intermediate-acting insulin with a slower onset of action and a longer duration of activity (up to 24 hours) than that of Regular human insulin. The time course of action of any insulin may vary considerably in different individuals or at different times in the same individual. As with all insulin preparations, the duration of action of Humulin N is dependent on dose, site of injection, blood supply, temperature, and physical activity. Humulin N is a sterile suspension and is for subcutaneous injection only. It should not be used intravenously or intramuscularly. The concentration of Humulin N is 100 units/mL (U-100).

Decadron (Drug Description)

DECADRON®
(dexamethasone) Tablets, USP

DECADRON* (dexamethasone tablets, USP) tablets, for oral administration, are supplied in two potencies, 0.5 mg and 0.75 mg. Inactive ingredients are calcium phosphate, lactose, magnesium stearate, and starch. Tablets DECADRON 0.5 mg also contain D&C Yellow 10 and FD&C Yellow 6. Tablets DECADRON 0.75 mg also contain FD&C Blue 1.

The molecular weight for dexamethasone is 392.47. It is designated chemically as 9-fluoro-11β,17,21-trihydroxy-16α-methylpregna-1,4-diene-3,20-dione. The empirical formula is C₂₂H₂₉FO₅ and the structural formula is:

Dexamethasone, a synthetic adrenocortical steroid, is a white to practically white, odorless, crystalline powder. It is stable in air. It is practically insoluble in water.

Fenofibrate 40 mg/ 120 mg (Drug Description)

Fenofibrate
(fenofibrate) 40 mg/120 mg Tablets

Fenofibrate Tablets, is a lipid regulating agent available as tablets for oral administration. Each tablet contains 40 mg or 120 mg fenofibrate. The chemical name for fenofibrate is 2-[4-(4-chlorobenzoyl) phenoxy]-2-methyl-propanoic acid, 1-methylethyl ester with the following structural formula:

The empirical formula is C₂₀H₂₁O₄Cl and the molecular weight is 360.83; fenofibrate is insoluble in water. The melting point is 79° to 82°C. Fenofibrate is a white solid which is stable under ordinary conditions. Inactive Ingredients: Each tablet contains lactose monohydrate, NF; Polyethylene Glycol 6000, NF; Poloxamer 188, NF; and magnesium stearate, NF.

Glucophage (Drug Description)

GLUCOPHAGE®
(metformin hydrochloride) Tablets

GLUCOPHAGE® XR
(metformin hydrochloride) Extended-Release Tablets

GLUCOPHAGE® (metformin hydrochloride tablets) and GLUCOPHAGE® XR (metformin hydrochloride extended-release tablets) are oral antihyperglycemic drugs used in the management of type 2 diabetes. Metformin hydrochloride (N,N-dimethylimidodicarbonimidic diamide hydrochloride) is not chemically or pharmacologically related to any other classes of oral antihyperglycemic agents. The structural formula is as shown:

Metformin hydrochloride is a white to off-white crystalline compound with a molecular formula of C₄H₁₁N₅ • HCl and a molecular weight of 165.63. Metformin hydrochloride is freely soluble in water and is practically insoluble in acetone, ether, and chloroform. The pK_a of metformin is 12.4. The pH of a 1% aqueous solution of metformin hydrochloride is 6.68.

GLUCOPHAGE tablets contain 500 mg, 850 mg, or 1000 mg of metformin hydrochloride. Each tablet contains the inactive ingredients povidone and magnesium stearate. In addition, the coating for the 500 mg and 850 mg tablets contains hypromellose and the coating for the 1000 mg tablet contains hypromellose and polyethylene glycol.

GLUCOPHAGE XR contains 500 mg or 750 mg of metformin hydrochloride as the active ingredient.

GLUCOPHAGE XR 500 mg tablets contain the inactive ingredients sodium carboxymethyl cellulose, hypromellose, microcrystalline cellulose, and magnesium stearate.

GLUCOPHAGE XR 750 mg tablets contain the inactive ingredients sodium carboxymethyl cellulose, hypromellose, and magnesium stearate.

Sandostatin LAR (Drug Description)

Sandostatin LAR® Depot
(octreotide acetate) for Injectable Suspension.

Octreotide is the acetate salt of a cyclic octapeptide. It is a long-acting octapeptide with pharmacologic properties mimicking those of the natural hormone somatostatin. Octreotide is known chemically as L-Cysteinamide, D-phenylalanyl-L-cysteinyl-L-phenylalanyl-D-tryptophyl-L-lysyl-L-threonyl-N-[2-hydroxy-1-(hydroxy-methyl) propyl]-, cyclic (2→7)-disulfide; [R-(R*,R*)].

Sandostatin LAR® Depot (octreotide acetate for injectable suspension) is available in a vial containing the sterile drug product, which when mixed with diluent, becomes a suspension that is given as a monthly intragluteal injection. The octreotide is uniformly distributed within the microspheres which are made of a biodegradable glucose star polymer, D,L-lactic and glycolic acids copolymer. Sterile mannitol is added to the microspheres to improve suspendability.

Sandostatin LAR® Depot is available as: sterile 5-mL vials in 3 strengths delivering 10 mg, 20 mg or 30 mg octreotide free peptide. Each vial of Sandostatin LAR® Depot delivers:

Name of Ingredient	10 mg	20 mg	30 mg
octreotide acetate	11.2 mg*	22.4 mg*	33.6 mg*
D, L-lactic and glycolic acids copolymer	188.8 mg	377.6 mg	566.4 mg
mannitol	41.0 mg	81.9 mg	122.9 mg
*Equivalent to 10/20/30 mg octreotide base.

Each syringe of diluent contains:

carboxymethylcellulose sodium.......... 12.5 mg
mannitol ............................................15.0 mg
water for injection .............................2.5 mL

Chantix (Drug Description)

CHANTIX®

(varenicline) Tablets

DRUG DESCRIPTION

CHANTIX™ tablets contain the active ingredient, varenicline (as the tartrate salt), which is a partial agonist selective for α₄β₂ nicotinic acetylcholine receptor subtypes.

Varenicline, as the tartrate salt, is a powder which is a white to off-white to slightly yellow solid with the following chemical name: 7,8,9,10-tetrahydro-6,10-methano-6H-pyrazino[2,3-h][3]benzazepine, (2R,3R)-2,3-dihydroxybutanedioate (1:1). It is highly soluble in water. Varenicline tartrate has a molecular weight of 361.35 Daltons, and a molecular formula of C₁₃H₁₃N₃•C₄H₆O₆. The chemical structure is:

CHANTIX is supplied for oral administration in two strengths: a 0.5 mg capsular biconvex, white to off-white, film-coated tablet debossed with "Pfizer" on one side and "CHX 0.5" on the other side and a 1 mg capsular biconvex, light blue film-coated tablet debossed with "Pfizer" on one side and "CHX 1.0" on the other side. Each 0.5 mg CHANTIX tablet contains 0.85 mg of varenicline tartrate equivalent to 0.5 mg of varenicline free base; each 1mg CHANTIX tablet contains 1.71 mg of varenicline tartrate equivalent to 1 mg of varenicline free base. The following inactive ingredients are included in the tablets: microcrystalline cellulose, anhydrous dibasic calcium phosphate, croscarmellose sodium, colloidal silicon dioxide, magnesium stearate, Opadry® White (for 0.5 mg), Opadry® Blue (for 1 mg), and Opadry® Clear.

VIAGRA (Drug Description)

VIAGRA®
(sildenafil citrate) Tablets

DRUG DESCRIPTION

VIAGRA®, an oral therapy for erectile dysfunction, is the citrate salt of sildenafil, a selective inhibitor of cyclic guanosine monophosphate (cGMP)-specific phosphodiesterase type 5 (PDE5).

Sildenafil citrate is designated chemically as 1-[[3-(6,7-dihydro-1-methyl-7-oxo-3-propyl-1H- pyrazolo[4,3-d]pyrimidin-5-yl)-4-ethoxyphenyl]sulfonyl]-4-methylpiperazine citrate and has the following structural formula:

Sildenafil citrate is a white to off-white crystalline powder with a solubility of 3.5 mg/mL in water and a molecular weight of 666.7. VIAGRA (sildenafil citrate) is formulated as blue, film-coated rounded-diamond-shaped tablets equivalent to 25 mg, 50 mg and 100 mg of sildenafil for oral administration. In addition to the active ingredient, sildenafil citrate, each tablet contains the following inactive ingredients: microcrystalline cellulose, anhydrous dibasic calcium phosphate, croscarmellose sodium, magnesium stearate, hypromellose, titanium dioxide, lactose, triacetin, and FD & C Blue #2 aluminum lake.

Quadramet (Drug Description)

QUADRAMET®
(samarium SM 153 lexidronam) Injection

Therapeutic – For Intravenous Administration

DRUG DESCRIPTION

QUADRAMET® is a therapeutic agent consisting of radioactive samarium and a tetraphosphonate chelator, ethylenediaminetetramethylenephosphonic acid (EDTMP). QUADRAMET® is formulated as a sterile, non-pyrogenic, clear, colorless to light amber isotonic solution of samarium-153 lexidronam for intravenous administration.

QUADRAMET® does not contain a preservative.

Each milliliter contains 35 mg EDTMP•H₂O, 5.3 mg Ca [as Ca(OH)₂], 14.1 mg Na [as NaOH], equivalent to 44 mg Ca/Na EDTMP (anhydrous calc.), 5-46 µg samarium (specific activity of approximately 1.0-11.0 mCi/µg Sm), and 1850 ± 185 MBq (50 ± 5 mCi) of samarium-153 at calibration.

The structural formula of samarium lexidronam pentasodium is:

The ionic formula is ¹⁵³Sm⁺³ [CH₂N(CH₂PO₃^-2)₂]₂ and the ionic formula weight is 581.1 daltons (pentasodium form, 696).

The pH of the solution is 7.0 to 8.5.

QUADRAMET® is supplied frozen in single-dose glass vials containing 3 mL with 5550 MBq (150 mCi) of samarium-153 at calibration.

Klonopin (Drug Description)

KLONOPIN®

(clonazepam) Tablets

KLONOPIN® Wafers
(clonazepam) Orally Disintegrating Tablets

DRUG DESCRIPTION

Klonopin, a benzodiazepine, is available as scored tablets with a K-shaped perforation containing 0.5 mg of clonazepam and unscored tablets with a K-shaped perforation containing 1 mg or 2 mg of clonazepam. Each tablet also contains lactose, magnesium stearate, microcrystalline cellulose and corn starch, with the following colorants: 0.5 mg-FD&C Yellow No. 6 Lake; 1 mg-FD&C Blue No. 1 Lake and FD&C Blue No. 2 Lake.

Klonopin is also available as an orally disintegrating tablet containing 0.125 mg, 0.25 mg, 0.5 mg, 1 mg or 2 mg clonazepam. Each orally disintegrating tablet also contains gelatin, mannitol, methylparaben sodium, propylparaben sodium and xanthan gum.

Chemically, clonazepam is 5-(2-chlorophenyl)-1,3-dihydro-7-nitro-2H-1,4-benzodiazepin-2-one. It is a light yellow crystalline powder. It has a molecular weight of 315.72 and the following structural formula:

Diazepam Injection (Drug Description)

Diazepam

(diazepam) Injection, Solution 5 mg/mL, Ampul, Fliptop Vial

DRUG DESCRIPTION

Diazepam Injection, USP is a sterile, nonpyrogenic solution intended for intramuscular or intravenous administration. Each milliliter (mL) contains 5 mg diazepam; 40% propylene glycol; 10% alcohol; 5% sodium benzoate and benzoic acid added as buffers; and 1.5% benzyl alcohol added as a preservative. pH 6.6 (6.2 to 6.9). Note: Solution may appear colorless to light yellow.

Diazepam is a benzodiazepine derivative chemically designated as 7-chloro-1,3-dihydro-1-methyl-5- phenyl-2H-1,4-benzodiazepin-2-one. It is a colorless crystalline compound, insoluble in water, with the following molecular structure:

Crixivan® (indinavir sulfate) Capsules

CRIXIVAN®
(indinavir sulfate) Capsules

DRUG DESCRIPTION

CRIXIVAN* (indinavir sulfate) isan inhibitor of the human immunodeficiency virus (HIV) protease. CRIXIVAN Capsules are formulated as a sulfate salt and are available for oral administration in strengths of 100, 200, 333, and 400 mg of indinavir (corresponding to 125, 250, 416.3, and 500 mg indinavir sulfate, respectively). Each capsule also contains the inactive ingredients anhydrous lactose and magnesium stearate.

The capsule shell has the following inactive ingredients and dyes: gelatin, titanium dioxide, silicon dioxide and sodium lauryl sulfate. The chemical name for indinavir sulfate is [1(1S,2R),5(S)]-2,3,5-trideoxy-N-(2,3-dihydro-2-hydroxy-1H-inden-1-yl)-5-[2-[[(1,1-dimethylethyl)amino]carbonyl]-4-(3-pyridinylmethyl)-1-piperazinyl]-2-(phenylmethyl)-D-erythro-pentonamide sulfate (1:1) salt. Indinavir sulfate has the following structural formula:

Indinavir sulfate is a white to off-white, hygroscopic, crystalline powder with the molecular formula C₃₆H₄₇N₅O₄ •H₂SO₄ and a molecular weight of 711.88. It is very soluble in water and in methanol.

Ascorbic acid (vitamin C)

Ascorbic acid (vitamin C) is a water-soluble vitamin. It occurs as a white or slightly yellow crystal or powder with a slight acidic taste. It is an antiscorbutic product. On exposure to light, it gradually darkens. In the dry state, it is reasonably stable in air, but in solution it rapidly oxidizes. Ascorbic acid is freely soluble in water; sparingly soluble in alcohol; insoluble in chloroform, in ether, and in benzene. The chemical name of ascorbic acid is L-ascorbic acid. The empirical formula is C6H806, and the molecular weight is 176.13. The structure is as follows:

Ascorbic Acid Injection is a sterile solution. Each mL contains: Ascorbic Acid 250 mg and Edetate Disodium 0.025% in Water for Injection qs. Prepared with the aid of Sodium Bicarbonate. Sodium Hydroxide and/or Hydrochloric Acid may have been used to adjust pH.