sigmapharm laboratories, llc - Medication Listings

Acitretin, USP, a retinoid, is available in 10-mg, 17.5-mg, and 25-mg gelatin capsules for oral administration. Chemically, acitretin is all-trans-9-(4-methoxy-2,3,6-trimethylphenyl)-3,7-dimethyl-2,4,6,8-nonatetraenoic acid. It is a metabolite of etretinate and is related to both retinoic acid and retinol (vitamin A). It is a yellow to greenish-yellow powder with a molecular weight of 326.43. The structural formula is: C 21 H 26 O 3 Each capsule contains acitretin, USP 10-mg, 17.5-mg, and 25-mg. Inactive ingredients are microcrystalline cellulose, sodium lauryl sulfate, maltodextrin, povidone and sodium ascorbate. The 10-mg, 17.5-mg, and 25-mg gelatin capsule shells contain gelatin, iron oxide (yellow), titanium dioxide, sodium lauryl sulfate and black imprinting ink. In addition, the 17.5-mg gelatin capsule shells also contain iron oxide (red). structure

Adefovir dipivoxil is a diester prodrug of adefovir. Adefovir is an acyclic nucleotide analog with activity against human hepatitis B virus (HBV). The chemical name of adefovir dipivoxil is 9-[2-[[bis[(pivaloyloxy)methoxy]-phosphinyl]-methoxy]ethyl]adenine. It has a molecular formula of C 20 H 32 N 5 O 8 P, a molecular weight of 501.48 and the following structural formula: Adefovir dipivoxil is a white to off-white crystalline powder with an aqueous solubility of 19 mg/mL at pH 2.0 and 0.4 mg/mL at pH 7.2. It has an octanol/aqueous phosphate buffer (pH 7) partition coefficient (log p) of 1.91. Adefovir Dipivoxil Tablets are for oral administration. Each tablet contains 10 mg of adefovir dipivoxil and the following inactive ingredients: copovidone, anhydrous lactose, microcrystalline cellulose, silicon dioxide, crospovidone and magnesium stearate. chemical structure

Ambrisentan is an endothelin receptor antagonist that is selective for the endothelin type-A (ET A ) receptor. The chemical name of ambrisentan is (+)-(2 S )-2-[(4,6-dimethylpyrimidin-2-yl)oxy]-3-methoxy-3,3-diphenylpropanoic acid. It has a molecular formula of C 22 H 22 N 2 O 4 and a molecular weight of 378.42. It contains a single chiral center determined to be the ( S ) configuration and has the following structural formula: Figure 1 Ambrisentan Structural Formula Ambrisentan is a white to off-white, crystalline solid. It is a carboxylic acid with a pKa of 4.0. Ambrisentan is practically insoluble in water and in aqueous solutions at low pH. Solubility increases in aqueous solutions at higher pH. In the solid state ambrisentan is very stable, is not hygroscopic, and is not light sensitive. Ambrisentan tablets are available as 5 mg and 10 mg film-coated tablets for once daily oral administration. The tablets include the following inactive ingredients: croscarmellose sodium, lactose monohydrate, magnesium stearate and microcrystalline cellulose. The tablets are film-coated with a coating material containing FD&C Red #40 aluminum lake, polyethylene glycol, polyvinyl alcohol, talc, and titanium dioxide. Ambrisentan tablets, 5 mg tablets also contain FD&C Blue #2. Each square shaped, light pink ambrisentan tablet contains 5 mg of ambrisentan. Each oval shaped, dark pink ambrisentan tablet contains 10 mg of ambrisentan. Ambrisentan tablets are unscored. figure1

Amiloride HCl, an antikaliuretic-diuretic agent, is a pyrazine-carbonyl-guanidine that is unrelated chemically to other known antikaliuretic or diuretic agents. It is the salt of a moderately strong base (pKa 8.7). It is designated chemically as 3,5-diamino-6-chloro-N-(diaminomethylene) pyrazinecarboxamide monohydrochloride, dihydrate and has a molecular weight of 302.12. Its empirical formula is C 6 H 8 CIN 7 O•HCl•2H 2 O and its structural formula is: Each tablet for oral administration contains 5 mg of Amiloride HCI, calculated on the anhydrous basis. Each tablet contains the following inactive ingredients: corn starch, crospovidone, lactose, magnesium stearate, microcrystalline cellulose and povidone. amiloride structure

Asenapine sublingual tablet(s) contains asenapine maleate which is an atypical antipsychotic that is available for sublingual administration. Asenapine belongs to the class dibenzo-oxepino pyrroles. The chemical designation is (3a RS ,12b RS )-5-Chloro-2-methyl-2,3,3a,12b-tetrahydro-1 H dibenzo[2,3:6,7]oxepino[4,5- c ]pyrrole (2 Z )-2-butenedioate (1:1). Its molecular formula is C 17 H 16 ClNO⋅C 4 H 4 O 4 and its molecular weight is 401.84 (free base: 285.8). The chemical structure is: Asenapine maleate is a white to off-white powder. Asenapine sublingual tablet(s), black cherry flavor, is supplied for sublingual administration in tablets containing 5 mg or 10 mg asenapine; inactive ingredients include copovidone, crospovidone, polyoxyl 35 castor oil, mannitol, magnesium stearate, citric acid, butylated hydroxytoluene, silicon dioxide, sodium bicarbonate and black cherry flavor. Black cherry flavor contains maltodextrin, artificial flavors, propylene glycol, triethyl citrate, and caramel color. asp-1

Disulfiram is an alcohol antagonist drug.

Dofetilide is an antiarrhythmic drug with Class III (cardiac action potential duration prolonging) properties. Its empirical formula is C 19 H 27 N 3 O 5 S 2 and it has a molecular weight of 441.6. The structural formula is The chemical name for dofetilide is: N -[4-[2-[methyl[2-[4-[(methylsulfonyl)amino]phenoxy]ethyl]amino]ethyl]phenyl]methanesulfonamide. Dofetilide is a white to off-white powder. It is very slightly soluble in water and propan-2-ol and is soluble in 0.1M aqueous sodium hydroxide, acetone, and aqueous 0.1M hydrochloric acid. Dofetilide Capsules contain the following inactive ingredients: microcrystalline cellulose, pregelatinized starch, silicon dioxide, magnesium stearate, anhydrous citric acid and copovidone. Dofetilide Capsules are supplied for oral administration in three dosage strengths: 125 mcg (0.125 mg) opaque orange capsules, 250 mcg (0.25 mg) opaque peach and white capsules, and 500 mcg (0.5 mg) opaque peach capsules. The capsule shell contains FD&C Red# 40, D&C Yellow# 10, titanium dioxide, sodium lauryl sulfate, gelatin and edible imprinting ink. The 0.125 mg strength capsule shell also contains D&C Red# 28. The ingredients in the imprinting ink include Ferrosoferric oxide, n-butyl alcohol, propylene glycol, shellac glaze~45% (20% esterified) in ethanol, FD&C Blue #2 Indigo Carmine Aluminum Lake, FD&C Blue #1/ Brilliant Blue FCF Aluminum Lake, FD&C Red #40/ Allura Red AC Aluminum Lake and D&C Yellow #10 Aluminum Lake. Chemical Structure

Flucytosine Capsules, USP are an antifungal agent available as 250 mg and 500 mg capsules for oral administration. In addition to the active ingredient of flucytosine, each capsule contains corn starch, lactose monohydrate and talc. The 250 mg capsule shell contains FD&C Yellow No. 6, FD&C Green No. 3, D&C Yellow No. 10, titanium dioxide, sodium lauryl sulfate and gelatin. The 500 mg capsule shell contains iron oxide yellow, iron oxide black, titanium dioxide, carboxymethylcellulose, sodium lauryl sulfate and gelatin. The imprinting ink used for 250 mg and 500 mg capsules contains black iron oxide. Chemically, flucytosine is 5-fluorocytosine, a fluorinated pyrimidine which is related to fluorouracil and floxuridine. It is a white to off-white crystalline powder with a molecular weight of 129.09 and the following structural formula: chemical structure

Prescribing Information DESCRIPTION Griseofulvin microsize contains griseofulvin microsize for oral administration. The active ingredient, griseofulvin, is a fungistatic antibiotic derived from a species of Penicillium . The chemical name of griseofulvin is 7-chloro-2’,4,6-trimethoxy-6’β-methylspiro[benzofuran-2(3H),1’-[2]cyclohexane]-3-4’-dione. Its structural formula is: C 17 H 17 ClO 6 M.W = 352.77 Griseofulvin occurs as a white to creamy white, bitter tasting powder which is very slightly soluble in water and sparingly soluble in alcohol. Griseofulvin microsize contains particles of approximately 2 to 4 µm in diameter. Griseofulvin Tablets, USP (microsize) 500 mg are white, capsule shaped, bisected tablets, debossed with ‘Σ’ and ‘12’ on either side of the bisection and plain on the other side. Each Griseofulvin Tablet, USP (microsize) 500 mg contains 500 mg of griseofulvin microsize, and also contains corn starch, povidone, polyethylene glycol 400, polyethylene glycol 8000, lactose monohydrate, crospovidone, silicon dioxide and magnesium stearate. Meets USP Dissolution Test 2. chemical structure

LIOMNY contains the active ingredient, liothyronine (L-triiodothyronine or LT3), a synthetic form of a thyroid hormone liothyronine in sodium salt form. It is chemically designated as L-Tyrosine, O -(4-hydroxy-3-iodophenyl)-3,5-diiodo-, monosodium salt. The molecular formula, molecular weight and structural formula of liothyronine sodium are given below. LIOMNY contains liothyronine sodium equivalent to liothyronine in 5 mcg, 25 mcg, and 50 mcg. Inactive ingredients consist of calcium sulfate dihydrate, corn starch, gelatin, magnesium stearate and mannitol. image description

Liothyronine Sodium Tablets, USP contain the active ingredient, liothyronine (L-triiodothyronine or LT3), a synthetic form of a thyroid hormone liothyronine in sodium salt form. It is chemically designated as L-Tyrosine, O -(4-hydroxy-3-iodophenyl)-3,5-diiodo-, monosodium salt. The molecular formula, molecular weight and structural formula of liothyronine sodium are given below. Liothyronine Sodium Tablets, USP contain liothyronine sodium equivalent to liothyronine in 5 mcg, 25 mcg, and 50 mcg. Inactive ingredients consist of calcium sulfate dihydrate, corn starch, gelatin, magnesium stearate and mannitol. image description

Protriptyline HCl is N-methyl-5H dibenzo [a,d]-cycloheptene-5-propanamine hydrochloride. Its molecular formula is C 19 H 21 N•HCl and its structural formula is: Protriptyline HCl, dibenzocycloheptene derivative, has a molecular weight of 299.84. It is a white to yellowish powder that is freely soluble in water and soluble in dilute HCl. Protriptyline HCl is supplied as 5 mg or 10 mg film-coated tablets. Inactive ingredients are anhydrous lactose, crospovidone, dibasic calcium phosphate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, talc, titanium dioxide, FD&C Yellow#6, and the 10 mg tablets contain D & C Yellow#10. protriptyline structure

Sodium Phenylbutyrate Powder for oral, nasogastric, or gastrostomy tube administration contain sodium phenylbutyrate. Sodium phenylbutyrate is an off-white crystalline substance which is soluble in water and has a strong salty taste. Sodium phenylbutyrate also is freely soluble in methanol and practically insoluble in acetone and diethyl ether. It is known chemically as 4-phenylbutyric acid, sodium salt with a molecular weight of 186 and the molecular formula C 10 H 11 O 2 Na. Chemical Structure: Each gram of Sodium Phenylbutyrate Powder contains 0.94 grams of sodium phenylbutyrate and the inactive ingredients calcium stearate NF, and colloidal silicon dioxide NF. chemical structure

Ultramicrosize Griseofulvin Tablets, USP contain ultramicrosize crystals of griseofulvin, an antibiotic derived from a species of Penicillium . The chemical name of griseofulvin, USP is 7-Chloro-2’,4’6-trimethoxy-6’β-methylspiro[benzofuran-2(3H),1’-[2]cyclohexene]-3,4’-dione. Its structural formula is: C 17 H 17 ClO 6 M.W. 352.77 Griseofulvin, USP occurs as a white to creamy white, odorless powder which is very slightly soluble in water, soluble in acetone, dimethylformamide, and chloroform and sparingly soluble in alcohol. Each ultramicrosize griseofulvin tablet contains ultramicrosize griseofulvin 125 mg or 250 mg and the following inactive ingredients: lactose monohydrate, corn starch, microcrystalline cellulose, povidone, polyethylene glycol 400, poloxamer 188, anhydrous lactose, silicon dioxide, crospovidone and magnesium stearate. structure