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Akorn Promethazine Hydrochloride and Codeine Phosphate Oral Solution

Addiction, Abuse, and Misuse

Promethazine HCl and codeine phosphate oral solution exposes patients and other users to the risks of opioid addiction, abuse, and misuse, which can lead to overdose and death. Reserve promethazine HCl and codeine phosphate oral solution for use in adult patients for whom the benefits of cough suppression are expected to outweigh the risks, and in whom an adequate assessment of the etiology of the cough has been made. Assess each patient’s risk prior to prescribing promethazine HCl and codeine phosphate oral solution, prescribe promethazine HCl and codeine phosphate oral solution for the shortest duration that is consistent with individual patient treatment goals, monitor all patients regularly for the development of addition or abuse, and refill only after reevaluation of the need for continued treatment

$350.00$3,000.00

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Promethazine HCl and codeine phosphate oral solution is a combination of codeine, an opioid agonist, and promethazine, a phenothiazine, indicated for the temporary relief of cough and upper respiratory symptoms associated with allergy or the common cold in patients 18 years of age and older.

DESCRIPTION

Promethazine HCl and Codeine Phosphate Oral Solution contains codeine, an opioid agonist, and promethazine, a phenothiazine.

Each 5 mL of Promethazine HCl and Codeine Phosphate Oral Solution contains 10 mg of codeine phosphate and 6.25 mg of promethazine hydrochloride for oral administration.

Promethazine HCl and Codeine Phosphate Oral Solution has a pH between 4.3 and 5.3 and contains alcohol 7%.

Promethazine HCl and Codeine Phosphate Oral Solution also contains the following inactive ingredients: Artificial boysenberry flavor, ascorbic acid, citric acid, D&C Red No. 33, FD&C Blue No. 1, FD&C Yellow No. 6, methylparaben, propylene glycol, propylparaben, purified water, saccharin sodium, sodium benzoate, sodium citrate, and sucrose syrup.

Codeine Phosphate

The chemical name for codeine phosphate is 7,8-Didehydro-4, 5α-epoxy-3-methoxy-17-methylmorphinan-6α-ol phosphate (1:1) (salt) hemihydrate. Codeine is one of the naturally occurring phenanthrene alkaloids of opium derived from the opium poppy, it is classified pharmacologically as a narcotic analgesic. The phosphate salt of codeine occurs as white, needle-shaped crystals or white crystalline powder. Codeine phosphate is freely soluble in water and slightly soluble in alcohol. The molecular weight is 406.37. Its molecular formula is C18H21NO3•H3PO4 • ½ H2O,

Important Dosage and Administration Instructions

Administer promethazine HCl and codeine phosphate oral solution by the oral route only.

Always use an accurate milliliter measuring device when administering promethazine HCl and codeine phosphate oral solution to ensure that the dose is measured and administered accurately. A household teaspoon is not an accurate measuring device and could lead to over dosage . For prescriptions where a measuring device is not provided, a pharmacist can provide an appropriate measuring device and can provide instructions for measuring the correct dose. Do not overfill. Rinse the measuring device with water after each use.

Advise patients not to increase the dose or dosing frequency of promethazine HCl and codeine phosphate oral solution because serious adverse events such as respiratory depression may occur with over dosage.  The dosage of promethazine HCl and codeine phosphate oral solution should not be increased if cough fails to respond; an unresponsive cough should be reevaluated for possible underlying pathology

Recommended Dosage

Adults 18 years of age and older: 5 mL every 4 to 6 hours as needed, not to exceed 6 doses (30 mL) in 24 hours.

Price Options

16oz, 16oz case

Ingredients Skimmed milk powder, lactose, vegetable oils (palm, rapeseed, sunflower), palm kernel fat, calcium carbonate, calcium salts of phosphoric acid, vitamin C, ferrous sulphate, stabilizer: L (+) - lactic acid, vitamin D, riboflavin , vitamin A, potassium iodate.
Nutritional values
Callories 110 kcal
Total Fat 0g / 0%
Total Carbohydrate 26g / 9%
Protein 3g / 10%
Available for age 6-12 months, 12-24 months

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