PROMETHAZINE HYDROCHLORIDE PHENYLEPHRINE HYDROCHLORIDE AND CODEINE PHOSPHATE

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Overview

What is PROMETHAZINE HYDROCHLORIDE PHENYLEPHRINE HYDROCHLORIDE AND CODEINE PHOSPHATE?

Each 5 mL (one teaspoonful), for oral administration contains: Codeine phosphate 10 mg; promethazine hydrochloride 6.25 mg; phenylephrine hydrochloride 5 mg. Alcohol 7%.

Inactive Ingredients: Ascorbic acid, citric acid, FD&C yellow #6, methylparaben, propylene glycol, propylparaben, purified water, sodium benzoate, sodium citrate, sucrose, sucrose syrup, tangerine flavor.

Codeine is one of the naturally occurring phenanthrene alkaloids of opium derived from the opium poppy; it is classified pharmacologically as a narcotic analgesic. Codeine phosphate may be chemically designated as 7,8-Didehydro-4,5α-epoxy-3-methoxy-17-methylmorphinan-6α-ol phosphate (1:1)(salt)hemi hydrate.

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. It has a molecular weight of 406.37, a molecular formula of CHNO • HPO • ½HO and the following structural formula:

Promethazine hydrochloride, a phenothiazine derivative, is chemically designated as (±)-10-[2-(Dimethylamino)propyl] phenothiazine monohydrochloride.

Promethazine hydrochloride occurs as a white to faint yellow, practically odorless, crystalline powder which slowly oxidizes and turns blue on prolonged exposure to air. It is soluble in water and freely soluble in alcohol. It has a molecular weight of 320.88, a molecular formula of CHNS • HCl and the following structural formula:

Phenylephrine hydrochloride is a sympathomimetic amine salt which is chemically designated as (-)-m-hydroxy-α-[(methyl-amino)methyl] benzyl alcohol hydrochloride. It occurs as white or nearly white crystals, having a bitter taste. It is freely soluble in water and alcohol. Phenylephrine hydrochloride is subject to oxidation and must be protected from light and air. It has a molecular weight of 203.67, a molecular formula of CHNO • HCl and the following structural formula:

What does PROMETHAZINE HYDROCHLORIDE PHENYLEPHRINE HYDROCHLORIDE AND CODEINE PHOSPHATE look like?

What are the available doses of PROMETHAZINE HYDROCHLORIDE PHENYLEPHRINE HYDROCHLORIDE AND CODEINE PHOSPHATE?

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What should I talk to my health care provider before I take PROMETHAZINE HYDROCHLORIDE PHENYLEPHRINE HYDROCHLORIDE AND CODEINE PHOSPHATE?

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How should I use PROMETHAZINE HYDROCHLORIDE PHENYLEPHRINE HYDROCHLORIDE AND CODEINE PHOSPHATE?

Promethazine HCl, Phenylephrine HCl and Codeine Phosphate Syrup is indicated for the temporary relief of coughs and upper respiratory symptoms, including nasal congestion, associated with allergy or the common cold.

It is important that Promethazine HCl, Phenylephrine HCl and Codeine Phosphate Syrup is measured with an accurate measuring device

The combination of promethazine hydrochloride, phenylephrine hydrochloride and codeine phosphate is contraindicated in pediatric patients less than 6 years of age, because the combination may cause fatal respiratory depression in this age population.

The average effective dose is given in the following table:

What interacts with PROMETHAZINE HYDROCHLORIDE PHENYLEPHRINE HYDROCHLORIDE AND CODEINE PHOSPHATE?

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What are the warnings of PROMETHAZINE HYDROCHLORIDE PHENYLEPHRINE HYDROCHLORIDE AND CODEINE PHOSPHATE?

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What are the precautions of PROMETHAZINE HYDROCHLORIDE PHENYLEPHRINE HYDROCHLORIDE AND CODEINE PHOSPHATE?

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What are the side effects of PROMETHAZINE HYDROCHLORIDE PHENYLEPHRINE HYDROCHLORIDE AND CODEINE PHOSPHATE?

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What should I look out for while using PROMETHAZINE HYDROCHLORIDE PHENYLEPHRINE HYDROCHLORIDE AND CODEINE PHOSPHATE?

Codeine is contraindicated in patients with a known hypersensitivity to the drug.

Promethazine is contraindicated in comatose states, and in individuals known to be hypersensitive or to have had an idiosyncratic reaction to promethazine or to other phenothiazines.

The combination of promethazine hydrochloride, phenylephrine hydrochloride and codeine phosphate is contraindicated in pediatric patients less than 6 years of age, because the combination may cause fatal respiratory depression in this age population.

Antihistamines and codeine are both contraindicated for use in the treatment of lower respiratory tract symptoms, including asthma.

Phenylephrine is contraindicated in patients with hypertension or with peripheral vascular insufficiency (ischemia may result with risk of gangrene or thrombosis of compromised vascular beds). Phenylephrine should not be used in patients known to be hypersensitive to the drug or in those receiving a monoamine oxidase inhibitor (MAOI).

The combination of promethazine hydrochloride, phenylephrine hydrochloride and codeine phosphate is contraindicated in pediatric patients less than 6 years of age.

Contaminant administration of promethazine products with other respiratory depressants has an association with respiratory depression, and sometimes death, in pediatric patients.

Postmarketing cases of respiratory depression, including fatalities, have been reported with use of promethazine hydrochloride in pediatric patients less than 2 years of age. A wide range of weight-based doses of promethazine hydrochloride have resulted in respiratory depression in these patients.

What might happen if I take too much PROMETHAZINE HYDROCHLORIDE PHENYLEPHRINE HYDROCHLORIDE AND CODEINE PHOSPHATE?

How should I store and handle PROMETHAZINE HYDROCHLORIDE PHENYLEPHRINE HYDROCHLORIDE AND CODEINE PHOSPHATE?

Store at controlled room temperature 15°-30° C (59°-86° F).Each 5 mL of yellow-orange, fruit-flavored syrup contains promethazine hydrochloride 6.25 mg, phenylephrine hydrochloride 5 mg, codeine phosphate 10 mg; and alcohol 7% and is available in 4 fluid ounce (118 mL), 8 fluid ounce (237 mL), and one pint (473 mL) bottles.Store at 20 - 25° C (68 - 77° F) [See USP Controlled Room Temperature].Protect from light.Dispense in a tight, light-resistant container as defined in the USP.Manufactured by:Actavis Mid Atlantic LLC1877 Kawai RoadLincolnton, NC 28092 USAFORM NO. 1629Rev. 08/11VC3351Each 5 mL of yellow-orange, fruit-flavored syrup contains promethazine hydrochloride 6.25 mg, phenylephrine hydrochloride 5 mg, codeine phosphate 10 mg; and alcohol 7% and is available in 4 fluid ounce (118 mL), 8 fluid ounce (237 mL), and one pint (473 mL) bottles.Store at 20 - 25° C (68 - 77° F) [See USP Controlled Room Temperature].Protect from light.Dispense in a tight, light-resistant container as defined in the USP.Manufactured by:Actavis Mid Atlantic LLC1877 Kawai RoadLincolnton, NC 28092 USAFORM NO. 1629Rev. 08/11VC3351Each 5 mL of yellow-orange, fruit-flavored syrup contains promethazine hydrochloride 6.25 mg, phenylephrine hydrochloride 5 mg, codeine phosphate 10 mg; and alcohol 7% and is available in 4 fluid ounce (118 mL), 8 fluid ounce (237 mL), and one pint (473 mL) bottles.Store at 20 - 25° C (68 - 77° F) [See USP Controlled Room Temperature].Protect from light.Dispense in a tight, light-resistant container as defined in the USP.Manufactured by:Actavis Mid Atlantic LLC1877 Kawai RoadLincolnton, NC 28092 USAFORM NO. 1629Rev. 08/11VC3351Each 5 mL of yellow-orange, fruit-flavored syrup contains promethazine hydrochloride 6.25 mg, phenylephrine hydrochloride 5 mg, codeine phosphate 10 mg; and alcohol 7% and is available in 4 fluid ounce (118 mL), 8 fluid ounce (237 mL), and one pint (473 mL) bottles.Store at 20 - 25° C (68 - 77° F) [See USP Controlled Room Temperature].Protect from light.Dispense in a tight, light-resistant container as defined in the USP.Manufactured by:Actavis Mid Atlantic LLC1877 Kawai RoadLincolnton, NC 28092 USAFORM NO. 1629Rev. 08/11VC3351Each 5 mL of yellow-orange, fruit-flavored syrup contains promethazine hydrochloride 6.25 mg, phenylephrine hydrochloride 5 mg, codeine phosphate 10 mg; and alcohol 7% and is available in 4 fluid ounce (118 mL), 8 fluid ounce (237 mL), and one pint (473 mL) bottles.Store at 20 - 25° C (68 - 77° F) [See USP Controlled Room Temperature].Protect from light.Dispense in a tight, light-resistant container as defined in the USP.Manufactured by:Actavis Mid Atlantic LLC1877 Kawai RoadLincolnton, NC 28092 USAFORM NO. 1629Rev. 08/11VC3351Each 5 mL of yellow-orange, fruit-flavored syrup contains promethazine hydrochloride 6.25 mg, phenylephrine hydrochloride 5 mg, codeine phosphate 10 mg; and alcohol 7% and is available in 4 fluid ounce (118 mL), 8 fluid ounce (237 mL), and one pint (473 mL) bottles.Store at 20 - 25° C (68 - 77° F) [See USP Controlled Room Temperature].Protect from light.Dispense in a tight, light-resistant container as defined in the USP.Manufactured by:Actavis Mid Atlantic LLC1877 Kawai RoadLincolnton, NC 28092 USAFORM NO. 1629Rev. 08/11VC3351Each 5 mL of yellow-orange, fruit-flavored syrup contains promethazine hydrochloride 6.25 mg, phenylephrine hydrochloride 5 mg, codeine phosphate 10 mg; and alcohol 7% and is available in 4 fluid ounce (118 mL), 8 fluid ounce (237 mL), and one pint (473 mL) bottles.Store at 20 - 25° C (68 - 77° F) [See USP Controlled Room Temperature].Protect from light.Dispense in a tight, light-resistant container as defined in the USP.Manufactured by:Actavis Mid Atlantic LLC1877 Kawai RoadLincolnton, NC 28092 USAFORM NO. 1629Rev. 08/11VC3351Each 5 mL of yellow-orange, fruit-flavored syrup contains promethazine hydrochloride 6.25 mg, phenylephrine hydrochloride 5 mg, codeine phosphate 10 mg; and alcohol 7% and is available in 4 fluid ounce (118 mL), 8 fluid ounce (237 mL), and one pint (473 mL) bottles.Store at 20 - 25° C (68 - 77° F) [See USP Controlled Room Temperature].Protect from light.Dispense in a tight, light-resistant container as defined in the USP.Manufactured by:Actavis Mid Atlantic LLC1877 Kawai RoadLincolnton, NC 28092 USAFORM NO. 1629Rev. 08/11VC3351Each 5 mL of yellow-orange, fruit-flavored syrup contains promethazine hydrochloride 6.25 mg, phenylephrine hydrochloride 5 mg, codeine phosphate 10 mg; and alcohol 7% and is available in 4 fluid ounce (118 mL), 8 fluid ounce (237 mL), and one pint (473 mL) bottles.Store at 20 - 25° C (68 - 77° F) [See USP Controlled Room Temperature].Protect from light.Dispense in a tight, light-resistant container as defined in the USP.Manufactured by:Actavis Mid Atlantic LLC1877 Kawai RoadLincolnton, NC 28092 USAFORM NO. 1629Rev. 08/11VC3351Each 5 mL of yellow-orange, fruit-flavored syrup contains promethazine hydrochloride 6.25 mg, phenylephrine hydrochloride 5 mg, codeine phosphate 10 mg; and alcohol 7% and is available in 4 fluid ounce (118 mL), 8 fluid ounce (237 mL), and one pint (473 mL) bottles.Store at 20 - 25° C (68 - 77° F) [See USP Controlled Room Temperature].Protect from light.Dispense in a tight, light-resistant container as defined in the USP.Manufactured by:Actavis Mid Atlantic LLC1877 Kawai RoadLincolnton, NC 28092 USAFORM NO. 1629Rev. 08/11VC3351Each 5 mL of yellow-orange, fruit-flavored syrup contains promethazine hydrochloride 6.25 mg, phenylephrine hydrochloride 5 mg, codeine phosphate 10 mg; and alcohol 7% and is available in 4 fluid ounce (118 mL), 8 fluid ounce (237 mL), and one pint (473 mL) bottles.Store at 20 - 25° C (68 - 77° F) [See USP Controlled Room Temperature].Protect from light.Dispense in a tight, light-resistant container as defined in the USP.Manufactured by:Actavis Mid Atlantic LLC1877 Kawai RoadLincolnton, NC 28092 USAFORM NO. 1629Rev. 08/11VC3351

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Clinical Information

Chemical Structure

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Clinical Pharmacology

Narcotic analgesics, including codeine, exert their primary effects on the central nervous system and gastrointestinal tract. The analgesic effects of codeine are due to its central action; however, the precise sites of action have not been determined, and the mechanisms involved appear to be quite complex. Codeine resembles morphine both structurally and pharmacologically, but its actions at the doses of codeine used therapeutically are milder, with less sedation, respiratory depression and gastrointestinal, urinary and pupillary effects. Codeine produces an increase in biliary tract pressure, but less than morphine or meperidine. Codeine is less constipating than morphine.

Codeine has good antitussive activity, although less than that of morphine at equal doses. It is used in preference to morphine, because side effects are infrequent at the usual antitussive dose of codeine.

Codeine in oral therapeutic dosage does not usually exert major effects on the cardiovascular system. Narcotic analgesics may cause nausea and vomiting by stimulating the chemoreceptor trigger zone (CTZ); however, they also depress the vomiting center, so that subsequent doses are unlikely to produce vomiting. Nausea is minimal after usual oral doses of codeine.

Narcotic analgesics cause histamine release, which appears to be responsible for wheals or urticaria sometimes seen at the site of injection on parenteral administration. Histamine release may also produce dilation of cutaneous blood vessels, with resultant flushing of the face and neck, pruritus and sweating.

Codeine and its salts are well absorbed following both oral and parenteral administration. Codeine is about 2/3 as effective orally as parenterally. Codeine is metabolized primarily in the liver by enzymes of the endoplasmic reticulum, where it undergoes O-demethylation, N-demethylation and partial conjugation with glucuronic acid. The drug is excreted primarily in the urine, largely as inactive metabolites and small amounts of free and conjugated morphine. Negligible amounts of codeine and its metabolites are found in the feces.

Following oral or subcutaneous administration of codeine, the onset of analgesia occurs within 15 to 30 minutes and lasts for four to six hours.

The cough-depressing action, in animal studies, was observed to occur 15 minutes after oral administration of codeine, peak action at 45 to 60 minutes after ingestion. The duration of action, which is dose-dependent, usually did not exceed 3 hours.

Non-Clinical Toxicology

Codeine is contraindicated in patients with a known hypersensitivity to the drug.

Promethazine is contraindicated in comatose states, and in individuals known to be hypersensitive or to have had an idiosyncratic reaction to promethazine or to other phenothiazines.

The combination of promethazine hydrochloride, phenylephrine hydrochloride and codeine phosphate is contraindicated in pediatric patients less than 6 years of age, because the combination may cause fatal respiratory depression in this age population.

Antihistamines and codeine are both contraindicated for use in the treatment of lower respiratory tract symptoms, including asthma.

Phenylephrine is contraindicated in patients with hypertension or with peripheral vascular insufficiency (ischemia may result with risk of gangrene or thrombosis of compromised vascular beds). Phenylephrine should not be used in patients known to be hypersensitive to the drug or in those receiving a monoamine oxidase inhibitor (MAOI).

The combination of promethazine hydrochloride, phenylephrine hydrochloride and codeine phosphate is contraindicated in pediatric patients less than 6 years of age.

Contaminant administration of promethazine products with other respiratory depressants has an association with respiratory depression, and sometimes death, in pediatric patients.

Postmarketing cases of respiratory depression, including fatalities, have been reported with use of promethazine hydrochloride in pediatric patients less than 2 years of age. A wide range of weight-based doses of promethazine hydrochloride have resulted in respiratory depression in these patients.

Narcotic analgesics, including codeine, should be administered with caution and the initial dose reduced in patients with acute abdominal conditions, convulsive disorders, significant hepatic or renal impairment, fever, hypothyroidism, Addison’s disease, ulcerative colitis, prostatic hypertrophy, in patients with recent gastrointestinal or urinary tract surgery and in the very young or elderly or debilitated patients.

Drugs having anticholinergic properties should be used with caution in patients with narrow-angle glaucoma, prostatic hypertrophy, stenosing peptic ulcer, pyloroduodenal obstruction, and bladder-neck obstruction.

Promethazine should be used cautiously in persons with cardiovascular disease or with impairment of liver function.

Phenylephrine should be used with caution in patients with cardiovascular disease.

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Reference

This information is obtained from the National Institute of Health's Standard Packaging Label drug database.
"https://dailymed.nlm.nih.gov/dailymed/"

While we update our database periodically, we cannot guarantee it is always updated to the latest version.

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