Promethazine Hydrochloride and Dextomethorphan Hydrobromide

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Overview

What is Promethazine Hydrochloride and Dextomethorphan Hydrobromide?

Each 5 mL (one teaspoonful), for oral administration contains: dextromethorphan hydrobromide 15 mg; promethazine hydrochloride 6.25 mg. Alcohol 7%.

Inactive Ingredients: Ascorbic Acid, Citric Acid, Edetate Disodium, FD&C Yellow #6, Glycerin, Methylparaben, Natural & Artificial Flavors, Purified Water, Saccharin Sodium, Sodium Benzoate, Sodium Citrate, and Sucrose.

Dextromethorphan hydrobromide is a salt of the methyl ether of the dextrorotatory isomer of levorphanol, a narcotic analgesic. It is chemically designated as 3-methoxy-17-methyl-9α,13α, 14α-morphinan hydrobromide monohydrate. Dextromethorphan hydrobromide occurs as white crystals sparingly soluble in water and freely soluble in alcohol. It has a molecular weight of 370.32, a molecular formula of CHNO•HBr•H0, and the following structural formula:

Promethazine is a racemic compound. Promethazine hydrochloride, a phenothiazine derivative, is chemically designated as "10-Phenothiazine-10-ethanamine, , α-trimethyl-, 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 •HCI, and the following structural formula:

What does Promethazine Hydrochloride and Dextomethorphan Hydrobromide look like?

What are the available doses of Promethazine Hydrochloride and Dextomethorphan Hydrobromide?

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What should I talk to my health care provider before I take Promethazine Hydrochloride and Dextomethorphan Hydrobromide?

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How should I use Promethazine Hydrochloride and Dextomethorphan Hydrobromide?

Promethazine hydrochloride and dextromethorphan hydrobromide oral solution is indicated for the temporary relief of coughs and upper respiratory symptoms associated with allergy or the common cold.

Promethazine hydrochloride and dextromethorphan hydrobromide oral solution is contraindicated for children under 2 years of age (see WARNINGS – Black Box Warning and Use in Pediatric Patients).

The average effective dose is given in the following table:

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What are the warnings of Promethazine Hydrochloride and Dextomethorphan Hydrobromide?

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What are the precautions of Promethazine Hydrochloride and Dextomethorphan Hydrobromide?

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What are the side effects of Promethazine Hydrochloride and Dextomethorphan Hydrobromide?

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What should I look out for while using Promethazine Hydrochloride and Dextomethorphan Hydrobromide?

Dextromethorphan should not be used in patients receiving a monoamine oxidase inhibitor (MAOI) (see ).

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.

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

WARNINGS:

PROMETHAZINE HYDROCHLORIDE SHOULD NOT BE USED IN PEDIATRIC PATIENTS LESS THAN 2 YEARS OF AGE BECAUSE OF THE POTENTIAL FOR FATAL RESPIRATORY DEPRESSION.

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.

CAUTION SHOULD BE EXERCISED WHEN ADMINISTERING PROMETHAZINE HYDROCHLORIDE TO PEDIATRIC PATIENTS 2 YEARS OF AGE AND OLDER. IT IS RECOMMENDED THAT THE LOWEST EFFECTIVE DOSE OF PROMETHAZINE HYDROCHLORIDE BE USED IN PEDIATRIC PATIENTS 2 YEARS OF AGE AND OLDER AND CONCOMITANT ADMINISTRATION OF OTHER DRUGS WITH RESPIRATORY DEPRESSANT EFFECTS BE AVOIDED.

What might happen if I take too much Promethazine Hydrochloride and Dextomethorphan Hydrobromide?

Dextromethorphan:

Promethazine:

Stimulation may be evident, especially in children and geriatric patients. Convulsions may rarely occur. A paradoxical reaction has been reported in children receiving single doses of 75 mg to 125 mg orally, characterized by hyperexcitability and nightmares.

Atropine-like signs and symptoms--dry mouth, fixed dilated pupils, flushing, as well as gastrointestinal symptoms, may occur.

Treatment:

Severe hypotension usually responds to the administration of norepinephrine or phenylephrine. EPINEPHRINE SHOULD NOT BE USED, since its use in a patient with partial adrenergic blockage may further lower the blood pressure.

Limited experience with dialysis indicates that it is not helpful.

How should I store and handle Promethazine Hydrochloride and Dextomethorphan Hydrobromide?

Store at 25°C (77°F); excursions permitted to 15-30°C (59-86°F) [see USP Controlled Room Temperature].Keep out of reach of children.Store at 25°C (77°F); excursions permitted to 15-30°C (59-86°F) [see USP Controlled Room Temperature].Keep out of reach of children.Promethazine hydrochloride and dextromethorphan hydrobromide oral solution is a clear, yellow colored, berry-flavored solution containing 6.25 mg promethazine hydrochloride, 15 mg dextromethorphan hydrobromide and 7 percent alcohol in each teaspoonful (5 mL).Available as:4 fl. oz (118 mL) NDC 65162-680-8616 fl. oz (473 mL) NDC-65162-680-90Store at 20°-25°C (68°-77°F); excursions permitted to 15°-30°C (59°-86°F); [See USP Controlled Room Temperature]. Dispense in tight, light-resistant container as defined in the USP.KEEP THIS AND ALL DRUGS OUT OF THE REACH OF CHILDREN.Rx OnlyManufactured by: .Branchburg, NJ 08876MF # 659 Rev. 2-2008 Promethazine hydrochloride and dextromethorphan hydrobromide oral solution is a clear, yellow colored, berry-flavored solution containing 6.25 mg promethazine hydrochloride, 15 mg dextromethorphan hydrobromide and 7 percent alcohol in each teaspoonful (5 mL).Available as:4 fl. oz (118 mL) NDC 65162-680-8616 fl. oz (473 mL) NDC-65162-680-90Store at 20°-25°C (68°-77°F); excursions permitted to 15°-30°C (59°-86°F); [See USP Controlled Room Temperature]. Dispense in tight, light-resistant container as defined in the USP.KEEP THIS AND ALL DRUGS OUT OF THE REACH OF CHILDREN.Rx OnlyManufactured by: .Branchburg, NJ 08876MF # 659 Rev. 2-2008 Promethazine hydrochloride and dextromethorphan hydrobromide oral solution is a clear, yellow colored, berry-flavored solution containing 6.25 mg promethazine hydrochloride, 15 mg dextromethorphan hydrobromide and 7 percent alcohol in each teaspoonful (5 mL).Available as:4 fl. oz (118 mL) NDC 65162-680-8616 fl. oz (473 mL) NDC-65162-680-90Store at 20°-25°C (68°-77°F); excursions permitted to 15°-30°C (59°-86°F); [See USP Controlled Room Temperature]. Dispense in tight, light-resistant container as defined in the USP.KEEP THIS AND ALL DRUGS OUT OF THE REACH OF CHILDREN.Rx OnlyManufactured by: .Branchburg, NJ 08876MF # 659 Rev. 2-2008 Promethazine hydrochloride and dextromethorphan hydrobromide oral solution is a clear, yellow colored, berry-flavored solution containing 6.25 mg promethazine hydrochloride, 15 mg dextromethorphan hydrobromide and 7 percent alcohol in each teaspoonful (5 mL).Available as:4 fl. oz (118 mL) NDC 65162-680-8616 fl. oz (473 mL) NDC-65162-680-90Store at 20°-25°C (68°-77°F); excursions permitted to 15°-30°C (59°-86°F); [See USP Controlled Room Temperature]. Dispense in tight, light-resistant container as defined in the USP.KEEP THIS AND ALL DRUGS OUT OF THE REACH OF CHILDREN.Rx OnlyManufactured by: .Branchburg, NJ 08876MF # 659 Rev. 2-2008 Promethazine hydrochloride and dextromethorphan hydrobromide oral solution is a clear, yellow colored, berry-flavored solution containing 6.25 mg promethazine hydrochloride, 15 mg dextromethorphan hydrobromide and 7 percent alcohol in each teaspoonful (5 mL).Available as:4 fl. oz (118 mL) NDC 65162-680-8616 fl. oz (473 mL) NDC-65162-680-90Store at 20°-25°C (68°-77°F); excursions permitted to 15°-30°C (59°-86°F); [See USP Controlled Room Temperature]. Dispense in tight, light-resistant container as defined in the USP.KEEP THIS AND ALL DRUGS OUT OF THE REACH OF CHILDREN.Rx OnlyManufactured by: .Branchburg, NJ 08876MF # 659 Rev. 2-2008 Promethazine hydrochloride and dextromethorphan hydrobromide oral solution is a clear, yellow colored, berry-flavored solution containing 6.25 mg promethazine hydrochloride, 15 mg dextromethorphan hydrobromide and 7 percent alcohol in each teaspoonful (5 mL).Available as:4 fl. oz (118 mL) NDC 65162-680-8616 fl. oz (473 mL) NDC-65162-680-90Store at 20°-25°C (68°-77°F); excursions permitted to 15°-30°C (59°-86°F); [See USP Controlled Room Temperature]. Dispense in tight, light-resistant container as defined in the USP.KEEP THIS AND ALL DRUGS OUT OF THE REACH OF CHILDREN.Rx OnlyManufactured by: .Branchburg, NJ 08876MF # 659 Rev. 2-2008 Promethazine hydrochloride and dextromethorphan hydrobromide oral solution is a clear, yellow colored, berry-flavored solution containing 6.25 mg promethazine hydrochloride, 15 mg dextromethorphan hydrobromide and 7 percent alcohol in each teaspoonful (5 mL).Available as:4 fl. oz (118 mL) NDC 65162-680-8616 fl. oz (473 mL) NDC-65162-680-90Store at 20°-25°C (68°-77°F); excursions permitted to 15°-30°C (59°-86°F); [See USP Controlled Room Temperature]. Dispense in tight, light-resistant container as defined in the USP.KEEP THIS AND ALL DRUGS OUT OF THE REACH OF CHILDREN.Rx OnlyManufactured by: .Branchburg, NJ 08876MF # 659 Rev. 2-2008 Promethazine hydrochloride and dextromethorphan hydrobromide oral solution is a clear, yellow colored, berry-flavored solution containing 6.25 mg promethazine hydrochloride, 15 mg dextromethorphan hydrobromide and 7 percent alcohol in each teaspoonful (5 mL).Available as:4 fl. oz (118 mL) NDC 65162-680-8616 fl. oz (473 mL) NDC-65162-680-90Store at 20°-25°C (68°-77°F); excursions permitted to 15°-30°C (59°-86°F); [See USP Controlled Room Temperature]. Dispense in tight, light-resistant container as defined in the USP.KEEP THIS AND ALL DRUGS OUT OF THE REACH OF CHILDREN.Rx OnlyManufactured by: .Branchburg, NJ 08876MF # 659 Rev. 2-2008 Promethazine hydrochloride and dextromethorphan hydrobromide oral solution is a clear, yellow colored, berry-flavored solution containing 6.25 mg promethazine hydrochloride, 15 mg dextromethorphan hydrobromide and 7 percent alcohol in each teaspoonful (5 mL).Available as:4 fl. oz (118 mL) NDC 65162-680-8616 fl. oz (473 mL) NDC-65162-680-90Store at 20°-25°C (68°-77°F); excursions permitted to 15°-30°C (59°-86°F); [See USP Controlled Room Temperature]. Dispense in tight, light-resistant container as defined in the USP.KEEP THIS AND ALL DRUGS OUT OF THE REACH OF CHILDREN.Rx OnlyManufactured by: .Branchburg, NJ 08876MF # 659 Rev. 2-2008 Promethazine hydrochloride and dextromethorphan hydrobromide oral solution is a clear, yellow colored, berry-flavored solution containing 6.25 mg promethazine hydrochloride, 15 mg dextromethorphan hydrobromide and 7 percent alcohol in each teaspoonful (5 mL).Available as:4 fl. oz (118 mL) NDC 65162-680-8616 fl. oz (473 mL) NDC-65162-680-90Store at 20°-25°C (68°-77°F); excursions permitted to 15°-30°C (59°-86°F); [See USP Controlled Room Temperature]. Dispense in tight, light-resistant container as defined in the USP.KEEP THIS AND ALL DRUGS OUT OF THE REACH OF CHILDREN.Rx OnlyManufactured by: .Branchburg, NJ 08876MF # 659 Rev. 2-2008

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Clinical Information

Chemical Structure

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Clinical Pharmacology

Dextromethorphan:

The drug acts centrally and elevates the threshold for coughing. It is about equal to codeine in depressing the cough reflex. In therapeutic dosage dextromethorphan does not inhibit ciliary activity.

Dextromethorphan is rapidly absorbed from the gastrointestinal tract and exerts its effect in 15 to 30 minutes. The duration of action after oral administration is approximately three to six hours. Dextromethorphan is metabolized primarily by liver enzymes undergoing 0-demethylation, N-demethylation, and partial conjugation with glucuronic acid and sulfate. In humans, (+)-3-hydroxy-N-methyl-morphinan, (+)-3-hydroxy-morphinan, and traces of unmetabolized drug were found in urine after oral administration.

Promethazine:

Promethazine is an H receptor blocking agent. In addition to its antihistaminic action, it provides clinically useful sedative and antiemetic effects.

Promethazine is well absorbed from the gastrointestinal tract. Clinical effects are apparent within 20 minutes after oral administration and generally last four to six hours, although they may persist as long as 12 hours. Promethazine is metabolized by the liver to a variety of compounds; the sulfoxides of promethazine and N-demethyl-promethazine are the predominant metabolites appearing in the urine.

Non-Clinical Toxicology

Dextromethorphan should not be used in patients receiving a monoamine oxidase inhibitor (MAOI) (see ).

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.

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

WARNINGS:

PROMETHAZINE HYDROCHLORIDE SHOULD NOT BE USED IN PEDIATRIC PATIENTS LESS THAN 2 YEARS OF AGE BECAUSE OF THE POTENTIAL FOR FATAL RESPIRATORY DEPRESSION.

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.

CAUTION SHOULD BE EXERCISED WHEN ADMINISTERING PROMETHAZINE HYDROCHLORIDE TO PEDIATRIC PATIENTS 2 YEARS OF AGE AND OLDER. IT IS RECOMMENDED THAT THE LOWEST EFFECTIVE DOSE OF PROMETHAZINE HYDROCHLORIDE BE USED IN PEDIATRIC PATIENTS 2 YEARS OF AGE AND OLDER AND CONCOMITANT ADMINISTRATION OF OTHER DRUGS WITH RESPIRATORY DEPRESSANT EFFECTS BE AVOIDED.

ACE Inhibitors:Concomitant administration of ACE inhibitors with potassium-sparing diuretics has been associated with severe hyperkalemia.

Alcohol, Barbiturates, Or Narcotics:Potentiation of orthostatic hypotension may occur.

Corticosteroids, ACTH:Intensified electrolyte depletion, particularly hypokalemia, may occur.

Pressor Amines (eg, Norepinephrine):Spironolactone reduces the vascular responsiveness to norepinephrine. Therefore, caution should be exercised in the management of patients subjected to regional or general anesthesia while they are being treated with spironolactone.

Skeletal Muscle Relaxants, Nondepolarizing (eg, Tubocurarine): Possible increased responsiveness to the muscle relaxant may result.

Lithium: Lithium generally should not be given with diuretics. Diuretic agents reduce the renal clearance of lithium and add a high risk of lithium toxicity.

Nonsteroidal Anti-inflammatory Drugs (NSAIDs): In some patients, the administration of an NSAID can reduce the diuretic, natriuretic, and antihypertensive effect of loop, potassium-sparing and thiazide diuretics. Combination of NSAIDs, eg, indomethacin, with potassium-sparing diuretics has been associated with severe hyperkalemia. Therefore, when spironolactone and NSAIDs are used concomitantly, the patient should be observed closely to determine if the desired effect of the diuretic is obtained.

Digoxin:Spironolactone has been shown to increase the half-life of digoxin. This may result in increased serum digoxin levels and subsequent digitalis toxicity. It may be necessary to reduce the maintenance and digitalization doses when spironolactone is administered, and the patient should be carefully monitored to avoid over or under digitalization.

Animal reproduction studies have not been conducted with the drug combination-promethazine and dextromethorphan. It is not known whether this drug combination can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Promethazine and dextromethorphan should be given to a pregnant woman only if clearly needed.

General:

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.

Dextromethorphan:

Promethazine:

Central Nervous System

Cardiovascular

Dermatologic

Hematologic

Gastrointestinal

Respiratory

WARNINGS - Promethazine

Respiratory Depression

Other

WARNINGS - Promethazine

Neuroleptic Malignant Syndrome

Paradoxical Reactions-Hyperexcitability and abnormal movements have been reported in patients following a single administration of promethazine HCI. Consideration should be given to the discontinuation of promethazine HCI and to the use of other drugs if these reactions occur. Respiratory depression, nightmares, delirium, and agitated behavior have also been reported in some of these patients.

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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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Clonazepam Description Each single-scored tablet, for oral administration, contains 0.5 mg, 1 mg, or 2 mg Clonazepam, USP, a benzodiazepine. Each tablet also contains corn starch, lactose monohydrate, magnesium stearate, microcrystalline cellulose, and povidone. Clonazepam tablets USP 0.5 mg contain Yellow D&C No. 10 Aluminum Lake. Clonazepam tablets USP 1 mg contain Yellow D&C No. 10 Aluminum Lake, as well as FD&C Blue No. 1 Aluminum Lake. Chemically, Clonazepam, USP is 5-(o-chlorophenyl)-1,3-dihydro-7-nitro-2H-1,4-benzodiazepin-2-one. It is a light yellow crystalline powder. It has the following structural formula: C15H10ClN3O3 M.W. 315.72

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Interactions

A total of 440 drugs (1549 brand and generic names) are known to interact with Imbruvica (ibrutinib). 228 major drug interactions (854 brand and generic names) 210 moderate drug interactions (691 brand and generic names) 2 minor drug interactions (4 brand and generic names) Show all medications in the database that may interact with Imbruvica (ibrutinib).

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