methapharm, inc. - Medication Listings

D-mannitol (referred to throughout as mannitol), the active ingredient in ARIDOL is a hexahydric alcohol, that is a sugar alcohol, with the following chemical name (2R,3R,4R,5R)-hexane-1,2,3,4,5,6-hexol and chemical structure: Mannitol is a white or almost white crystalline powder of free-flowing granules with an empirical formula of C 6 H 14 O 6 and molecular weight of 182.2. Mannitol is freely soluble in water, and very slightly soluble in alcohol. Mannitol shows polymorphism. The ARIDOL Bronchial Challenge Test Kit contains one single patient use dry powder inhaler and 3 consecutively numbered foil blister packs containing a total of 19 capsules of mannitol for oral inhalation. All except the 0 mg printed hard gelatin capsules contain dry powder mannitol for oral inhalation. The accompanying dry powder inhaler is a plastic device used for inhaling the capsules. All doses are to be administered using the same device supplied with each kit without washing or sterilizing the device at anytime during the test. To use the delivery system, a mannitol capsule is placed in the well of the inhaler, and the capsule is pierced by pressing and releasing the buttons ONCE on the side of the device. The mannitol dry powder is dispersed into the air stream when the patient inhales deeply through the mouthpiece. There are no inactive ingredients in the mannitol capsules supplied with the ARIDOL Bronchial Challenge Test Kit. The 0 mg capsule and the bodies of the 5, 10, 20 and 40 mg capsules are clear. The white caps (5 mg) contain titanium dioxide. The yellow caps (10 mg) contain titanium dioxide and yellow iron oxide. The pink caps (20 mg) and red caps (40 mg) contain titanium dioxide and red iron dioxide. The inhaler is a plastic device used for administering mannitol to the lungs. The amount of drug delivered to the lung will depend on patient factors, such as inspiratory flow rate and inspiratory time. Under standardized in vitro testing at a fixed flow rate of 60 L/min for 2 seconds, the delivered dose from the inhaler from each of the 5, 10, 20 and 40 mg capsules is approximately 3.4, 7.7, 16.5 and 34.1 mg, respectively. Peak inspiratory flow rates (PIFR) achievable through the inhaler were evaluated in healthy and asthmatic individuals ranging from 7 to 65 years of age and with % FEV 1 of predicted ranging from 67% to 123%. PIFR achieved in the study was at least 70.8 L/min in all subjects assessed. The mean PIFR was 118.2 L/min and approximately ninety percent of each population studied generated a PIFR through the device exceeding 90 L/min. Aridol-kit-1

Asclera is a sterile, nonpyrogenic, and colorless to faintly greenish-yellow solution of polidocanol for intravenous use as a sclerosing agent. The active ingredient, polidocanol is a non-ionic detergent, consisting of two components, a polar hydrophilic (dodecyl alcohol) and an apolar hydrophobic (polyethylene oxide) chain. Polidocanol has the following structural formula: C 12 H 25 (OCH 2 CH 2 ) n OH Polyethylene glycol monododecyl ether Mean extent of polymerization (n) : Approximately 9 Mean molecular weight : Approximately 600 Each mL contains 5 mg (0.5%) or 10 mg (1.0%) polidocanol in water for injection with 5% (v/v) ethanol at pH 6.5-8.0; disodium hydrogen phosphate dihydrate (1.2 mg), potassium dihydrogen phosphate (0.43 mg). chemical structure

Methacholine chloride, the active ingredient of Provocholine, is a parasympathomimetic (cholinergic) bronchoconstrictor agent. Provocholine (methacholine chloride) powder for solution is administered by oral inhalation. Chemically, methacholine chloride (the active ingredient) is 1-propanaminium, 2-(acetyloxy)-N,N,N,-trimethyl-, chloride. It is a white to practically white deliquescent compound, soluble in water, alcohol and chloroform and insoluble in ether. Aqueous solutions are neutral to litmus. Methacholine chloride has an empirical formula of C 8 H 18 ClNO 2 , a molecular weight of 195.69, and the following structural formula: Provocholine Powder for Solution: Each vial of Provocholine contains 100 mg of methacholine chloride powder. Provocholine Solution for Inhalation Kit (Sterile): Each kit is packaged in a carton with six plastic vials with twist-off cap each containing 3 mL of the following concentrations of methacholine chloride solution. Each solution also contains: Sodium Acetate Trihydrate, Sodium Chloride, glacial acetic acid as pH adjuster. a) base solution (contains no methacholine chloride) b) 0.0625 mg/mL (0.1875 mg/3 mL) c) 0.25 mg/mL (0.75 mg/3 mL) d) 1 mg/mL (3 mg/3 mL) e) 4 mg/mL (12 mg/3 mL) f) 16 mg/mL (48 mg/3 mL) structure