Promethazine

Laboratory Report # 3.2 Title:         Promethazine 0.2% Syrup         Date:                 Student Name: 1.         Describe the dispensing directions for the preparation:         A. Indication and expected action:                         Promethazine HCL is a powerful antihistamine drug used to treat allergic conditions and,                 because of the sedative action, insomnia. It is also used as an anti-tussive in cough mixtures.         Promethazine can be administered by mouth or injection.

        B. Directions/administration/use: Sig:         TAKE ONE TEASPOONFUL OF SYRUP BY MOUTH AT MEALTIMES AND AT BEDTIME.

        C. Precautions/DI: Keep medication out of reach of children Do not drink alcohol while on this medication Contraindications: ·         children under 2yrs ·         SC or intra-arterial injection ·         narrow-angle glaucoma ·         prostatic hypertrophy ·         bladder or pyeloduodenal obstruction ·         MAOI therapy ·         hypersensitivity to promethazine and other phenothiazines Adverse Reactions: drowsiness dizziness ·         xerostomia ·         extrapyramidal reactions                 Drug Interactions: belladonna benztropine cabergoline cisapride dofetilide gatifloxacin grepafloxacin halofantrine levofloxacin lithium meperidine moxifloxacin orphenadrine pimozide porfimer procyclidine sotalol sparfloxacin tramadol trihexyphenidyl         D. Storage: Keep the syrup at room temperature, away from heat, light, and moisture. Do not freeze.

        E. Missed Dose: Use your medicine as soon as you remember that you have missed your dose.

If it is nearly time for your next dose, wait until then to use the medicine and skip the missed dose. You should not use two doses at one time.

2.         Purpose of each excipient used in the experiment: Cocoa         -         flavoring agent Sucrose         -         sweetening agent, suspending and viscosity-increasing agent.

Liquid Glucose         -         to provide calories, taste, and to improve transport of sodium                                 and water across the intestinal barrier through osmosis         Glycerin         -         used as a demulcent in cough preparations for soothing and protecting                         the mucous membranes and relieves irritation. When administered by                         mouth or parenterally, glycerin increases the plasma osmolality,                         resulting in the movement of water by osmosis from the extra vascular                         spaces into the plasma.

Sodium Chloride-         electrolyte - source of sodium (Na+), used in combination with glucose for oral rehydration in acute diarrhea.

Vanillin         -         flavoring/perfuming agent Sodium Benzoate         preservative with antibacterial and anti-fungal properties Pure Water         -         diluent 3.         Show your calculations and compounding (in steps):         Calculations: Promethazine HCL         2 g                 x         (90mL / 1000mL)         =         0.18 g Cocoa         180 g         x         (90mL / 1000mL)         =         16.2 g Sucrose         600 g         x         (90mL / 1000mL)         =         54 g Liquid Glucose         180 g         x         (90mL / 1000mL)         =         16.2 g Glycerin         50 mL         x         (90mL / 1000mL)         =         4.5 mL x (1.25g/mL) = 5.625 g Sodium Chloride         2.0 g         x         (90mL / 1000mL)         =         0.18g sp. gravity Vanillin         0.2 g         x         (90mL / 1000mL)         =         0.018 g Sodium Benzoate         1.0 g         x         (90mL / 1000mL)         =         0.09 g P. Water         1000 mL         x         (90mL / 1000mL)         =         90 mL Ft. 90 mL         Promethazine:         (2 g / 1000 mL)         x 100 % = 0.2% syrup         1 Tsp = 5 mL x (0.2 % / 100 %) = 0.01 g x (1000 mg / 1 g) = 10 mg / dose Preparation: The sucrose and cocoa were mixed together in a beaker. To this mixture, the glucose, glycerin and vanillin were gradually added. The sodium benzoate and sodium chloride were then dissolved in a small amount (30 mL) of hot water. The promethazine HCL was then added to the solution and was mixed well. The contents were then transferred to the mixture in the beaker. The entire mixture was brought to a boil and the boiling temperature was maintained for 2 minutes. The mixture was allowed to cool to room temperature and the volume was brought up to 90 mL by adding additional pure water.