amneal pharmaceuticals private limited - Medication Listings

Calcium gluconate injection USP, 100 mg per mL is a sterile, clear, colorless to slightly yellow, preservative-free, nonpyrogenic, supersaturated solution of calcium gluconate, a form of calcium, for intravenous use. The chemical name of calcium gluconate monohydrate, USP is calcium D-gluconate (1:2) monohydrate. The structural formula is: Molecular formula: C 12 H 22 CaO 14 •H 2 O Molecular weight: 448.39 g/mol Solubility in water: 3.5 g/100 mL at 25°C Calcium gluconate monohydrate, USP is a white, crystalline granules or powder. It is soluble in boiling water, sparingly soluble in water and insoluble in alcohol. Calcium Gluconate Injection, USP is available as 1,000 mg per 10 mL (100 mg per mL) or 5,000 mg per 50 mL (100 mg per mL) in a single-dose vial or 10,000 mg per 100 mL (100 mg per mL) in a pharmacy bulk package. Each mL of calcium gluconate injection, USP contains: 100 mg of calcium gluconate (equivalent to 94 mg of calcium gluconate and 4.5 mg of calcium saccharate tetrahydrate), hydrochloric acid and/or sodium hydroxide for pH adjustment (6.0 to 8.2) and sterile water for injection, q.s. It contains no antimicrobial agent. Each mL of calcium gluconate injection, USP contains 9.3 mg (0.465 mEq) of elemental calcium. 1

Calcium gluconate in sodium chloride injection is a sterile, clear, colorless, preservative-free, nonpyrogenic, solution of calcium gluconate, a form of calcium, for intravenous use. The chemical name of calcium gluconate monohydrate, USP is calcium D-gluconate (1:2) monohydrate. The structural formula is Molecular formula: C 12 H 22 CaO 14 • H 2 O Molecular weight: 448.39 g/mol Solubility in water: 3.5 g/100 mL at 25°C Calcium gluconate monohydrate, USP is a white, crystalline granules or powder. It is soluble in boiling water, sparingly soluble in water and insoluble in alcohol. Calcium Gluconate in Sodium Chloride Injection is available as 1,000 mg per 50 mL (18.8 mg per mL) or 2,000 mg per 100 mL (18.8 mg per mL) filled in single-dose infusion bags. Each mL of calcium gluconate in sodium chloride injection contains 20 mg of calcium gluconate (equivalent to 18.8 mg of calcium gluconate and 0.9 mg of calcium saccharate tetrahydrate), 6.75 mg sodium chloride as tonicity adjustor, hydrochloric acid and/or sodium hydroxide for pH adjustment (6.0 to 8.2) and water for injection. Each mL of calcium gluconate in sodium chloride injection contains 1.86 mg (0.093 mEq) of elemental calcium. 1

Cupric chloride injection USP, 0.4 mg/mL is a sterile, clear, colorless to light blue color, nonpyrogenic solution intended for use as an additive to intravenous solutions for total parenteral nutrition (TPN). Each mL of solution contains 1.07 mg cupric chloride dihydrate; 9 mg sodium chloride and water for injection. The solution contains no bacteriostat, antimicrobial agent or added buffer. The pH is 2.0 (1.5 to 2.5); product may contain hydrochloric acid and sodium hydroxide for pH adjustment. The osmolarity is 0.327 mOsmol/mL (calc.). Cupric chloride, USP is chemically designated cupric chloride, dihydrate. Its molecular weight is 170.48 g/mol. The molecular formula is CuCl 2 • 2H 2 O and the structural formula is: Cupric chloride, USP is a blue to blue-green crystalline compound freely soluble in water, soluble in alcohol and slightly soluble in ether. Sodium chloride, USP is chemically designated NaCl, a white crystalline compound freely soluble in water. The semi-rigid vial is fabricated from a specially formulated polyolefin. It is a copolymer of ethylene and propylene. The small amount of water vapor that can pass through the plastic container wall will not significantly alter the drug concentration. 1

Epinephrine Injection, USP is a clear, colorless, sterile solution containing 1 mg/mL epinephrine USP, packaged as 1 mL of solution in a single-dose clear glass vial. In the 1 mL vial, each 1 mL of epinephrine injection, USP solution contains 1 mg epinephrine, USP; 9 mg sodium chloride; 1 mg sodium metabisulfite; hydrochloric acid to adjust pH and water for injection. The pH range is 2.2 to 5.0. Epinephrine is a sympathomimetic catecholamine. The chemical name of epinephrine is: 1,2-Benzenediol, 4-[1-hydroxy-2-(methylamino)ethyl]-,( R )- or (-)-3,4-Dihydroxy-α-[(methylamino)methyl]benzyl alcohol. Its chemical structure is: The molecular weight of epinephrine is 183.2 g/mol and molecular formula is C 9 H 13 NO 3 . Epinephrine solution deteriorates rapidly on exposure to air or light, turning pink from oxidation to adrenochrome and brown from the formation of melanin. 1

Iohexol, USP is a nonionic radiographic contrast agent available as: Iohexol injection for intrathecal, intra-arterial, intravenous, oral, rectal, intraarticular and body cavity use. The chemical name of iohexol, USP is N,N’ -Bis(2,3-dihydroxypropyl)-5-[ N -(2,3-dihydroxypropyl) acetamido]-2,4,6-triiodoisophthalamide with a molecular weight of 821.14 (iodine content 46.36%). Iohexol has the following structural formula: Iohexol Injection, USP is a sterile, pyrogen-free, clear, colorless to pale yellow solution available in following concentrations of iodine: Iohexol Injection USP, 300 mg iodine/mL: Each mL contains 647 mg iohexol, USP (providing 300 mg organically bound iodine) and the following inactive ingredients: 0.1 mg edetate calcium disodium, USP; 1.21 mg tromethamine, USP and water for injection. Iohexol Injection USP 350 mg iodine/mL: Each mL contains 755 mg iohexol, USP (providing 350 mg organically bound iodine) and the following inactive ingredients: 0.1 mg edetate calcium disodium, USP; 1.21 mg tromethamine, USP and water for injection. The pH is adjusted between 6.8 and 7.7 with hydrochloric acid or sodium hydroxide. Iohexol injection contain no preservatives and no ingredient made from a gluten-containing grain (wheat, barley, or rye). Iohexol injection have the following physical properties: Table 21: Physicochemical Properties of Iohexol Injection Dosage Form Concentration (mg iodine/mL) Osmolality * (mOsmol/kg water) Absolute Viscosity (cP) Specific Gravity 20°C 37°C 37°C Injection 300 659 11.48 6.05 1.344 350 774 21.48 12.16 1.4054 * By Freezing Point Depression Osmometer. Iohexol injection has osmolalities from approximately 2.4 times that of plasma (285 mOsmol/kg water) or cerebrospinal fluid (301 mOsmol/kg water) as shown in the above table and are hypertonic. 1

Metronidazole injection, USP, is a parenteral formulation of the synthetic nitroimidazole antibacterial agent 2-methyl-5-nitro-1 H -imidazole-1-ethanol. Metronidazole injection USP, 500 mg/100 mL (5 mg/mL) is a sterile, clear, colorless to pale yellow color, nonpyrogenic, iso-osmotic, buffered solution supplied in 100 mL single-dose non-PVC plastic container. Each 100 mL contains 500 mg metronidazole, USP; 790 mg sodium chloride, USP; 47.6 mg dibasic sodium phosphate dried, USP; and 22.9 mg citric acid anhydrous, USP. Metronidazole injection, USP has an osmolarity of 308.66 mOsmol/L (calc) and a pH of 5.5 (4.5 to 7.0). Each container contains 14 mEq of sodium. 1

Potassium Phosphates Injection, USP, a phosphorus replacement product containing phosphorus 3 mmol/mL and potassium 4.4 mEq/mL. It is a sterile clear, colorless, non-pyrogenic, concentrated solution containing a mixture of monobasic potassium phosphate, USP and dibasic potassium phosphate, USP in water for injection. It is supplied as a 5 mL and 15 mL single-dose vials and a 50 mL Pharmacy Bulk Package vial. Monobasic potassium phosphate, USP is chemically designated potassium dihydrogen phosphate. The molecular formula is KH 2 PO 4 , molecular weight is 136.084 g/mol and the structural formula is as below: It appears as colorless crystals or white granular or crystalline powder. It is freely soluble in water and practically insoluble in alcohol. Dibasic potassium phosphate, USP is chemically designated dipotassium hydrogen phosphate. The molecular formula is K 2 HPO 4 , molecular weight is 174.18 g/mol and the structural formula is as below: It appears as colorless crystals or white granular or crystalline powder. It is freely soluble in water. Each mL of Potassium Phosphates Injection, USP contains monobasic potassium phosphate USP, 224 mg; dibasic potassium phosphate USP, 236 mg and water for injection. Each mL contains 3 mmol phosphorus (equivalent to 93 mg phosphorus) and 4.4 mEq potassium (equivalent to 170 mg of potassium). Note: 1 mmol of phosphorus is equal to 1 mmol phosphate. The pH is 6.0 to 7.0. This product contains no more than 900 mcg/L of aluminum [ see Warnings and Precautions (5.5) ] . The osmolarity is 7.4 mOsmol/mL (calc). The solution is administered after dilution or admixing by the intravenous route. 1 1

Potassium Phosphates Injection, USP, a phosphorus replacement product containing phosphorus 3 mmol/mL and potassium 4.4 mEq/mL. It is a sterile clear, colorless, non-pyrogenic, concentrated solution containing a mixture of monobasic potassium phosphate, USP and dibasic potassium phosphate, USP in water for injection. It is supplied as a 15 mL single-dose vial. Monobasic potassium phosphate, USP is chemically designated potassium dihydrogen phosphate. The molecular formula is KH 2 PO 4 , molecular weight is 136.084 g/mol and the structural formula is as below: It appears as colorless crystals or white granular or crystalline powder. It is freely soluble in water and practically insoluble in alcohol. Dibasic potassium phosphate, USP is chemically designated dipotassium hydrogen phosphate. The molecular formula is K 2 HPO 4 , molecular weight is 174.18 g/mol and the structural formula is as below: It appears as colorless crystals or white granular or crystalline powder. It is freely soluble in water. Each mL of Potassium Phosphates Injection, USP contains monobasic potassium phosphate USP, 224 mg; dibasic potassium phosphate USP, 236 mg and water for injection. Each mL contains 3 mmol phosphorus (equivalent to 93 mg phosphorus) and 4.4 mEq potassium (equivalent to 170 mg of potassium). Note: 1 mmol of phosphorus is equal to 1 mmol phosphate. The pH is 6.0 to 7.0. This product contains no more than 900 mcg/L of aluminum [ see Warnings and Precautions (5.5) ] . The osmolarity is 7.4 mOsmol/mL (calc). The solution is administered after dilution or admixing by the intravenous route. 1 2

Propofol injectable emulsion USP, 10 mg per mL is an anesthetic available as a sterile, nonpyrogenic, white, homogeneous emulsion for intravenous administration. The structural formula of propofol, USP is: Chemical name: 2,6 diisopropylphenol Molecular formula: C 12 H 18 O Molecular weight: 178.28 g/mol Propofol, USP is a clear, colorless to slightly yellowish liquid. It is very soluble in methanol and in ethanol, slightly soluble in cyclohexane and in isopropyl alcohol and very slightly soluble in water. The pKa is 11. The octanol/water partition coefficient for propofol is 6761:1 at a pH of 6.0 to 8.5. Each mL of propofol injectable emulsion, USP contains 10 mg propofol, USP; soybean oil, 100 mg; glycerol, 22.5 mg; egg phospholipids, 12 mg; disodium edetate anhydrous, 0.05 mg and sodium hydroxide to adjust pH, in water for injection. Propofol injectable emulsion, USP is isotonic and has a pH of 7.00 to 8.50. 1

Sodium acetate injection, USP (2 mEq/mL) is a sterile, clear, colorless, nonpyrogenic, concentrated solution of sodium acetate in water for injection. The solution is administered after dilution by the intravenous route as an electrolyte replenisher. It must not be administered undiluted. Each mL contains 164 mg of sodium acetate, USP (anhydrous) which provides 2 mEq each of sodium (Na + ) and acetate (CH 3 COO - ). The solution contains no bacteriostat, antimicrobial agent or added buffer. May contain acetic acid for pH adjustment; the pH is 6.5 (6.0 to 7.0). The osmolar concentration is 4 mOsmol/mL (calc.); specific gravity 1.081. The solution is intended as an alternative to sodium chloride to provide sodium ion (Na + ) for addition to large volume infusion fluids for intravenous use. Sodium acetate, USP, anhydrous is chemically designated CH 3 COONa, a hygroscopic powder freely soluble in water. A Pharmacy Bulk Package is a container of a sterile preparation for parenteral use that contains many single doses. The contents are intended for use in a pharmacy admixture program and are restricted to the preparation of admixtures for intravenous infusion.

Sodium bicarbonate injection, USP is a sterile, nonpyrogenic, hypertonic solution of sodium bicarbonate (NaHCO 3 ) in water for injection for administration by the intravenous route as an electrolyte replenisher and systemic alkalizer. Solution is offered in concentration of 8.4%. See table in HOW SUPPLIED section for contents and characteristics. The solution contains no bacteriostat, antimicrobial agent or added buffer and are intended only for use as a single-dose injection, the approximate pH of the solution is between 7.0 to 8.5. When smaller doses are required, the unused portion should be discarded. Sodium bicarbonate USP, 84 mg is equal to one milliequivalent each of Na + and HCO 3 - . Sodium bicarbonate, USP is chemically designated NaHCO 3 , a white crystalline powder soluble in water and insoluble in ethanol. Water for injection, USP is chemically designated H 2 O.

Tranexamic acid, USP is trans-4-(aminomethyl)cyclohexanecarboxylic acid, an antifibrinolytic agent. Tranexamic acid, USP is a white, crystalline powder. The structural formula is Molecular Formula: C 8 H 15 NO 2 Molecular Weight: 157.21 g/mol Tranexamic Acid in 0.7% Sodium Chloride Injection, 1,000 mg per 100 mL (10 mg per mL) is a sterile, clear, colorless, nonpyrogenic injectable solution for intravenous administration. Each IV bag contains: 1,000 mg of tranexamic acid, USP; 700 mg of sodium chloride, USP and water for injection, USP. The aqueous solution has a pH of 6.5 to 8.0. 1

Tranexamic acid, USP is trans-4-(aminomethyl)cyclohexanecarboxylic acid, an antifibrinolytic agent. Tranexamic acid, USP is a white, crystalline powder. The structural formula is Molecular Formula: C 8 H 15 NO 2 Molecular Weight: 157.21 g/mol Tranexamic Acid in 0.7% Sodium Chloride Injection, 1,000 mg per 100 mL (10 mg per mL) is a sterile, clear, colorless, nonpyrogenic injectable solution for intravenous administration. Each IV bag contains: 1,000 mg of tranexamic acid, USP; 700 mg of sodium chloride, USP and water for injection, USP. The aqueous solution has a pH of 6.5 to 8.0. 1