Promethazine Hydrochloride and Dextromethophan Hydrobromide

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Overview

What is Promethazine Hydrochloride and Dextromethophan 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, D&C yellow #10, FD&C yellow #6, methylparaben, natural and artificial raspberry flavor, propylene glycol, propylparaben, purified water, saccharin sodium, sodium benzoate, sodium citrate, and sucrose syrup.

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•HO, 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 Dextromethophan Hydrobromide look like?

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

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

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How should I use Promethazine Hydrochloride and Dextromethophan 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

Use in Pediatric Patients

The average effective dose is given in the following table:

What interacts with Promethazine Hydrochloride and Dextromethophan Hydrobromide?

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What are the warnings of Promethazine Hydrochloride and Dextromethophan Hydrobromide?

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What are the precautions of Promethazine Hydrochloride and Dextromethophan Hydrobromide?

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

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What should I look out for while using Promethazine Hydrochloride and Dextromethophan 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.

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

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

Promethazine Hydrochloride and Dextromethorphan Hydrobromide Oral Solution 6.25 mg/15 mg per 5 mL is a clear, yellow, raspberry-flavored solution supplied as follows:in 4 fl oz (118 mL) bottlesin 8 fl oz (237 mL) bottlesin 16 fl oz (473 mL) bottlesKeep tightly closed. Protect from light.Store at 20°-25°C (68°-77°F) [See USP Controlled Room Temperature].Dispense in a tight, light-resistant container as defined in the USP.Manufactured by:Hi-Tech Pharmacal Co., Inc.Amityville, NY 11701Rev.803:05 08/16Promethazine Hydrochloride and Dextromethorphan Hydrobromide Oral Solution 6.25 mg/15 mg per 5 mL is a clear, yellow, raspberry-flavored solution supplied as follows:in 4 fl oz (118 mL) bottlesin 8 fl oz (237 mL) bottlesin 16 fl oz (473 mL) bottlesKeep tightly closed. Protect from light.Store at 20°-25°C (68°-77°F) [See USP Controlled Room Temperature].Dispense in a tight, light-resistant container as defined in the USP.Manufactured by:Hi-Tech Pharmacal Co., Inc.Amityville, NY 11701Rev.803:05 08/16Promethazine Hydrochloride and Dextromethorphan Hydrobromide Oral Solution 6.25 mg/15 mg per 5 mL is a clear, yellow, raspberry-flavored solution supplied as follows:in 4 fl oz (118 mL) bottlesin 8 fl oz (237 mL) bottlesin 16 fl oz (473 mL) bottlesKeep tightly closed. Protect from light.Store at 20°-25°C (68°-77°F) [See USP Controlled Room Temperature].Dispense in a tight, light-resistant container as defined in the USP.Manufactured by:Hi-Tech Pharmacal Co., Inc.Amityville, NY 11701Rev.803:05 08/16Promethazine Hydrochloride and Dextromethorphan Hydrobromide Oral Solution 6.25 mg/15 mg per 5 mL is a clear, yellow, raspberry-flavored solution supplied as follows:in 4 fl oz (118 mL) bottlesin 8 fl oz (237 mL) bottlesin 16 fl oz (473 mL) bottlesKeep tightly closed. Protect from light.Store at 20°-25°C (68°-77°F) [See USP Controlled Room Temperature].Dispense in a tight, light-resistant container as defined in the USP.Manufactured by:Hi-Tech Pharmacal Co., Inc.Amityville, NY 11701Rev.803:05 08/16Promethazine Hydrochloride and Dextromethorphan Hydrobromide Oral Solution 6.25 mg/15 mg per 5 mL is a clear, yellow, raspberry-flavored solution supplied as follows:in 4 fl oz (118 mL) bottlesin 8 fl oz (237 mL) bottlesin 16 fl oz (473 mL) bottlesKeep tightly closed. Protect from light.Store at 20°-25°C (68°-77°F) [See USP Controlled Room Temperature].Dispense in a tight, light-resistant container as defined in the USP.Manufactured by:Hi-Tech Pharmacal Co., Inc.Amityville, NY 11701Rev.803:05 08/16Promethazine Hydrochloride and Dextromethorphan Hydrobromide Oral Solution 6.25 mg/15 mg per 5 mL is a clear, yellow, raspberry-flavored solution supplied as follows:in 4 fl oz (118 mL) bottlesin 8 fl oz (237 mL) bottlesin 16 fl oz (473 mL) bottlesKeep tightly closed. Protect from light.Store at 20°-25°C (68°-77°F) [See USP Controlled Room Temperature].Dispense in a tight, light-resistant container as defined in the USP.Manufactured by:Hi-Tech Pharmacal Co., Inc.Amityville, NY 11701Rev.803:05 08/16Promethazine Hydrochloride and Dextromethorphan Hydrobromide Oral Solution 6.25 mg/15 mg per 5 mL is a clear, yellow, raspberry-flavored solution supplied as follows:in 4 fl oz (118 mL) bottlesin 8 fl oz (237 mL) bottlesin 16 fl oz (473 mL) bottlesKeep tightly closed. Protect from light.Store at 20°-25°C (68°-77°F) [See USP Controlled Room Temperature].Dispense in a tight, light-resistant container as defined in the USP.Manufactured by:Hi-Tech Pharmacal Co., Inc.Amityville, NY 11701Rev.803:05 08/16Promethazine Hydrochloride and Dextromethorphan Hydrobromide Oral Solution 6.25 mg/15 mg per 5 mL is a clear, yellow, raspberry-flavored solution supplied as follows:in 4 fl oz (118 mL) bottlesin 8 fl oz (237 mL) bottlesin 16 fl oz (473 mL) bottlesKeep tightly closed. Protect from light.Store at 20°-25°C (68°-77°F) [See USP Controlled Room Temperature].Dispense in a tight, light-resistant container as defined in the USP.Manufactured by:Hi-Tech Pharmacal Co., Inc.Amityville, NY 11701Rev.803:05 08/16Promethazine Hydrochloride and Dextromethorphan Hydrobromide Oral Solution 6.25 mg/15 mg per 5 mL is a clear, yellow, raspberry-flavored solution supplied as follows:in 4 fl oz (118 mL) bottlesin 8 fl oz (237 mL) bottlesin 16 fl oz (473 mL) bottlesKeep tightly closed. Protect from light.Store at 20°-25°C (68°-77°F) [See USP Controlled Room Temperature].Dispense in a tight, light-resistant container as defined in the USP.Manufactured by:Hi-Tech Pharmacal Co., Inc.Amityville, NY 11701Rev.803:05 08/16Promethazine Hydrochloride and Dextromethorphan Hydrobromide Oral Solution 6.25 mg/15 mg per 5 mL is a clear, yellow, raspberry-flavored solution supplied as follows:in 4 fl oz (118 mL) bottlesin 8 fl oz (237 mL) bottlesin 16 fl oz (473 mL) bottlesKeep tightly closed. Protect from light.Store at 20°-25°C (68°-77°F) [See USP Controlled Room Temperature].Dispense in a tight, light-resistant container as defined in the USP.Manufactured by:Hi-Tech Pharmacal Co., Inc.Amityville, NY 11701Rev.803:05 08/16Promethazine Hydrochloride and Dextromethorphan Hydrobromide Oral Solution 6.25 mg/15 mg per 5 mL is a clear, yellow, raspberry-flavored solution supplied as follows:in 4 fl oz (118 mL) bottlesin 8 fl oz (237 mL) bottlesin 16 fl oz (473 mL) bottlesKeep tightly closed. Protect from light.Store at 20°-25°C (68°-77°F) [See USP Controlled Room Temperature].Dispense in a tight, light-resistant container as defined in the USP.Manufactured by:Hi-Tech Pharmacal Co., Inc.Amityville, NY 11701Rev.803:05 08/16

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Clinical Information

Chemical Structure

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Clinical Pharmacology

Dextromethorphan is an antitussive agent and, unlike the isomeric levorphanol, it has no analgesic or addictive properties.

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 O-demethylation, N-demethylation, and partial conjugation with glucuronic acid and sulfate. In humans, (+)-3-hydroxy-N-methylmorphinan, (+)-3-hydroxy-morphinan, and traces of unmetabolized drug were found in urine after oral administration.

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.

Dextromethorphan

Hyperpyrexia, hypotension, and death have been reported coincident with the coadministration of monoamine oxidase (MAO) inhibitors and products containing dextromethorphan. Thus, concomitant administration of promethazine with dextromethorphan and MAO inhibitors should be avoided (see ).

Promethazine

CNS Depressants

barbiturates), narcotics, narcotic analgesics, general anesthetics, tricyclic antidepressants, and tranquilizers; therefore, such agents should be avoided or administered in reduced dosage to patients receiving promethazine HCI. When given concomitantly with promethazine, the dose of barbiturates should be reduced by at least one-half, and the dose of narcotics should be reduced by one-quarter to one-half. Dosage must be individualized. Excessive amounts of promethazine HCI relative to a narcotic may lead to restlessness and motor hyperactivity in the patient with pain; these symptoms usually disappear with adequate control of the pain.

Epinephrine

Anticholinergics

Monoamine oxidase inhibitors (MAOI)

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.

To report SUSPECTED ADVERSE REACTIONS, contact Hi-Tech Pharmacal Co., Inc. at 1-800-262-9010 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

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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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