navinta llc - Medication Listings

Benztropine mesylate is a synthetic compound containing structural features found in atropine and diphenhydramine. It is designated chemically as 8-azabicyclo[3.2.1] octane, 3-(diphenylmethoxy)-, endo , methanesulfonate. Its empirical formula is C 21 H 25 NO•CH 4 O 3 S, and its structural formula is: Benztropine mesylate is a crystalline white powder, very soluble in water, and has a molecular weight of 403.54. Benztropine mesylate injection, USP is supplied as a sterile injection for intravenous and intramuscular use. Each milliliter of the injection contains: Benztropine mesylate USP----------------------------------------------------------------------------------1 mg Sodium chloride USP----------------------------------------------------------------------------------------9 mg Water for injection USP q.s.--------------------------------------------------------------------------------1 mL benztropine-fig-01

Carglumic acid tablets for oral suspension contain 200 mg of carglumic acid. Carglumic acid, the active substance, is a carbamoyl phosphate synthetase 1 (CPS 1) activator and is soluble in dimethyl formamide and sparingly soluble in water. The chemical name of carglumic acid is N-carbamoyl-L-glutamic acid or (2S)-2-(carbamoylamino) pentanedioic acid. The empirical formula is C 6 H 10 N 2 O 5 and the molecular weight is 190.16. The structural formula is: The inactive ingredients of carglumic acid tablets for oral suspension are croscarmellose sodium, microcrystalline cellulose, sodium lauryl sulfate, colloidal silicon dioxide and sodium stearyl fumarate. Image

The active ingredient in carmustine for injection, USP is a nitrosourea with the chemical name 1,3-bis(2-chloroethyl)-1-nitrosourea and a molecular weight of 214.06. The drug product is supplied as sterile lyophilized pale yellow flakes or a congealed mass, and it is highly soluble in alcohol and lipids, and poorly soluble in water. Carmustine for injection, USP is administered by intravenous infusion after reconstitution, as recommended. The structural formula of carmustine is: Carmustine for injection, USP is available in 100-mg single-dose vials of lyophilized material. Sterile diluent for constitution of carmustine for injection, USP is co-packaged with the active drug product for use in constitution of the lyophile. The diluent is supplied in a vial containing 3 mL of Dehydrated Alcohol Injection, USP. Image

The active ingredient in famotidine for oral suspension is a histamine-2 (H 2 ) receptor antagonist. Famotidine is N' -(aminosulfonyl)-3-[[[2-[(diaminomethylene)amino]-4-thiazolyl]methyl]thio] propanimidamide. The empirical formula of famotidine is C 8 H 15 N 7 O 2 S 3 and its molecular weight is 337.43. Its structural formula is: Each 5 mL of famotidine for oral suspension when prepared as directed contains 40 mg of famotidine and the following inactive ingredients: anhydrous citric acid, cherry flavor, confectioner's sugar, microcrystalline cellulose and carboxymethylcellulose sodium, mint flavor, and xanthan gum. Additionally, following inactive ingredients are added as preservatives: methylparaben sodium 0.1%, and sodium benzoate 0.1%. Famotidine is a white to pale yellow crystalline compound that is freely soluble in glacial acetic acid, slightly soluble in methanol, very slightly soluble in water, and practically insoluble in ethanol. Image

Fomepizole Injection is a competitive inhibitor of alcohol dehydrogenase. The chemical name of fomepizole is 4-methylpyrazole. It has the molecular formula C 4 H 6 N 2 and a molecular weight of 82.1. The structural formula is: It is a clear to yellow liquid at room temperature. Its melting point is 25°C(77°F) and it may present as solid form at room temperature. Fomepizole is soluble in water and very soluble in ethanol, diethyl ether, and chloroform. Each vial contains 1.5 mL (1 g/mL) of fomepizole. Image

Hydralazine hydrochloride injection, USP is an antihypertensive available in a 1 mL vial for intravenous and intramuscular administration. Hydralazine hydrochloride injection, USP is a sterile, nonpyrogenic clear, colorless solution. Each mL contains: Active: Hydralazine hydrochloride USP, 20 mg Preservative Free Formulation Inactives: Propylene glycol USP, 103.6 mg; sodium hydroxide and/or hydrochloric acid USP to adjust pH (3.4 to 4.4) and water for injection. Hydralazine hydrochloride USP is 1-hydrazinophthalazine monohydrochloride, and its structural formula is: Molecular Formula C 8 H 8 N 4 •HCl Hydralazine hydrochloride USP is a white to off-white, odorless crystalline powder. It is soluble in water, slightly soluble in alcohol, and very slightly soluble in ether. It melts at about 288.90°C, with decomposition, and has a molecular weight of 196.64. Image

Maraviroc is a selective, slowly reversible, small molecule antagonist of the interaction between human CCR5 and HIV-1 gp120. Blocking this interaction prevents CCR5-tropic HIV-1 entry into cells. Maraviroc film-coated tablets for oral administration contain 150, or 300 mg of maraviroc and the following inactive ingredients: anhydrous dibasic calcium phosphate, hydroxypropyl methyl cellulose, magnesium stearate, microcrystalline cellulose, and sodium starch glycolate. The film coat (Opadry white II 85Fl8422) contains polyethylene glycol, polyvinyl alcohol, talc and titanium dioxide. Maraviroc is chemically described as 4,4-difluoro- N -{(1S)-3-[ exo -3-(3-isopropyl-5-methyl-4 H -1,2,4-triazol-4-yl)-8-azabicyclo[3.2.1]oct-8-yl]-1-phenylpropyl}cyclohexanecarboxamide. The molecular formula is C 29 H 41 F 2 N 5 O and the structural formula is: Maraviroc is a white to off-white color crystalline powder with a molecular weight of 513.67. It is highly soluble across the physiological pH range (pH 1.0 to 7.5). Image

Miglustat capsules, 100 mg are glucosylceramide synthase inhibitor, which is a glucosyl transferase enzyme responsible for the first step in the synthesis of most glycosphingolipids. Miglustat is an N-alkylated imino sugar, a synthetic analog of D-glucose. The chemical name for miglustat is 1,5-(butylimino)-1,5-dideoxy-D-glucitol with the chemical formula C 10 H 21 NO 4 and a molecular weight of 219.28. Miglustat is a white to off-white crystalline powder and has a bitter taste. It is highly soluble in water (>1000 mg/mL as a free base). Miglustat capsules are supplied in hard gelatin capsules each containing 100 mg miglustat for oral administration. Each miglustat 100 mg capsule also contains magnesium stearate, povidone (K30), and sodium starch glycolate. Ingredients in the capsule shell include gelatin and titanium dioxide, and the shells are printed with black ink consisting of black iron oxide, potassium hydroxides and shellac. Image

Penicillamine is a chelating agent used in the treatment of Wilson's disease. It is also used to reduce cystine excretion in cystinuria and to treat patients with severe, active rheumatoid arthritis unresponsive to conventional therapy (see INDICATIONS ). It is 3-mercapto-D-valine. It is a white, or practically white, crystalline powder, freely soluble in water, slightly soluble alcohol, insoluble in chloroform and in ether. Although its configuration is D, it is levorotatory as usually measured: [α] 25°= -62.5° ± 2° (c = 1, 1N NaOH), D calculated on a dried basis. The empirical formula is C 5 H 11 NO 2 S, giving it a molecular weight of 149.21. The structural formula is: It reacts readily with formaldehyde or acetone to form a thiazolidine-carboxylic acid. Penicillamine Capsules, USP for oral administration contain 250 mg of penicillamine. Each capsule contains the following inactive ingredients: lactose monohydrate, magnesium stearate, D&C yellow no. 10, gelatin and titanium dioxide. The imprinting ink contains shellac, dehydrated alcohol, isopropyl alcohol, butyl alcohol, propylene glycol, strong ammonia solution, black iron oxide, potassium hydroxide and purified water. Image

Ribavirin is a synthetic nucleoside with antiviral activity. Ribavirin for inhalation solution, USP is a sterile, lyophilized powder to be reconstituted for aerosol administration. Each 100 mL glass vial contains 6 grams of ribavirin, and when reconstituted to the recommended volume of 300 mL with sterile water for injection or sterile water for inhalation (no preservatives added), will contain 20 mg of ribavirin per mL, pH approximately 5.5. Aerosolization is to be carried out in a Small Particle Aerosol Generator (SPAG-2) nebulizer only. Ribavirin is 1-beta-D-ribofuranosyl-1H-1,2,4-triazole-3-carboxamide, with the following structural formula: Ribavirin is a stable, white crystalline compound with a maximum solubility in water of 142 mg/mL at 25°C and with only a slight solubility in ethanol. The empirical formula is C 8 H 12 N 4 O 5 and the molecular weight is 244.21. Image

The active ingredient in sevelamer carbonate tablets is sevelamer carbonate, a polymeric amine that binds phosphate and is meant for oral administration. It was developed as a pharmaceutical alternative to sevelamer hydrochloride (Renagel ® ). Sevelamer carbonate is an anion exchange resin, with the same polymeric structure as sevelamer hydrochloride, in which carbonate replaces chloride as the counterion. While the counterions differ for the two salts, the polymer itself, the active moiety involved in phosphate binding, is the same. Sevelamer carbonate is known chemically as poly(allylamine- co -N,N′-diallyl-1,3-diamino-2-hydroxypropane) carbonate salt. Sevelamer carbonate is hygroscopic, but insoluble in water. The structure is represented in Figure 1. Figure 1: Chemical Structure of Sevelamer Carbonate a, b = number of primary amine groups a + b = 9 c = number of cross-linking groups c = 1 m = large number to indicate extended polymer network Sevelamer Carbonate Tablets : Each film-coated tablet of sevelamer carbonate contains 800 mg of sevelamer carbonate on an anhydrous basis. The inactive ingredients are colloidal silicon dioxide, copovidone, hydroxypropyl cellulose, microcrystalline cellulose, sodium stearyl fumarate and purified water. The film coating contains hypromellose, hydroxypropyl cellulose, macrogol/polyethylene glycol and titanium dioxide. Image

Sodium Phenylacetate and Sodium Benzoate Injection 10% per 10% (a nitrogen binding agent), is a sterile, concentrated, aqueous solution of sodium phenylacetate and sodium benzoate. The pH of the solution is between 7.0 and 8.0. Sodium phenylacetate is a white to off-white powder. It is soluble in water. Sodium benzoate is a white to off-white powder that is readily soluble in water. Figure 1 Sodium phenylacetate has a molecular weight of 158.14 and the molecular formula C 8 H 7 NaO 2 . Sodium benzoate has a molecular weight of 144.10 and the molecular formula C 7 H 5 NaO 2 . Each mL of Sodium Phenylacetate and Sodium Benzoate Injection contains 100 mg of sodium phenylacetate and 100 mg of sodium benzoate, and Water for Injection. Sodium hydroxide and/or hydrochloric acid may have been used for pH adjustment. Sodium Phenylacetate and Sodium Benzoate Injection is a sterile, concentrated solution intended for intravenous administration via a central venous catheter only after dilution [ see Dosage and Administration (2) ]. structure-figure-01

sodium phenylacetate and sodium benzoate injection (a nitrogen binding agent), is a sterile, concentrated, aqueous solution of sodium phenylacetate and sodium benzoate. The pH of the solution is between 6 and 8. Sodium phenylacetate is a white to off-white powder. It is soluble in water. Sodium benzoate is a white to off-white powder that is readily soluble in water. Figure 1 Sodium phenylacetate has a molecular weight of 158.14 and the molecular formula C 8 H 7 NaO 2 . Sodium benzoate has a molecular weight of 144.10 and the molecular formula C 7 H 5 NaO 2 . Each mL of sodium phenylacetate and sodium benzoate injection contains 100 mg of sodium phenylacetate and 100 mg of sodium benzoate, and Water for Injection. Sodium hydroxide and/or hydrochloric acid may have been used for pH adjustment. Sodium phenylacetate and sodium benzoate injection is a sterile, concentrated solution intended for intravenous administration via a central venous catheter only after dilution [ see Dosage and Administration (2) ]. figure-1

Trientine hydrochloride is N,N'-bis (2-aminoethyl)-1,2-ethanediamine dihydrochloride. It is a white to pale yellow crystalline hygroscopic powder. It is freely soluble in water, soluble in methanol, slightly soluble in ethanol, and insoluble in chloroform and ether. The empirical formula is C 6 H 18 N 4 •2HCl with a molecular weight of 219.2. The structural formula is: NH 2 (CH 2 ) 2 NH(CH 2 ) 2 NH(CH 2 ) 2 NH 2 •2HCl Trientine hydrochloride is a chelating compound for removal of excess copper from the body. Trientine hydrochloride, USP is available as 250 mg capsules for oral administration. Trientine hydrochloride capsules, USP contain stearic acid, gelatin, titanium dioxide and FD&C yellow 6 as inactive ingredients. Imprinting ink contains shellac, propylene glycol, black iron oxide and potassium hydroxide.