Promethazine Hydrochloride and Phenylephrine Hydrochloride

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Overview

What is Promethazine Hydrochloride and Phenylephrine Hydrochloride?

Promethazine Hydrochloride and Phenylephrine Hydrochloride Syrup is a yellow-orange colored, fruit flavored syrup. Each 5 mL (one teaspoonful), for oral administration contains: Promethazine hydrochloride 6.25 mg; phenylephrine hydrochloride 5 mg. Alcohol 7%.

Inactive Ingredients:

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 and Phenylephrine Hydrochloride look like?

What are the available doses of Promethazine Hydrochloride and Phenylephrine Hydrochloride?

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

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How should I use Promethazine Hydrochloride and Phenylephrine Hydrochloride?

Promethazine hydrochloride and phenylephrine hydrochloride syrup is indicated for the temporary relief of upper respiratory symptoms, including nasal congestion, associated with allergy or the common cold.

Promethazine hydrochloride and phenylephrine hydrochloride syrup is contraindicated for children under 2 years of age (see

The recommended doses are given in the following table:

Adults And Children 12 Years And Over

1 teaspoonful (5 mL) every 4 to 6 hours, not to exceed 6 teaspoonsful (30 mL) in 24 hours.

Children 6 To Under 12 Years Of Age

½ to 1 teaspoonful (2.5 to 5 mL) every 4 to 6 hours, not to exceed 6 teaspoonsful (30 mL) in 24 hours.

Children 2 To Under 6 Years Of Age

¼ to ½ teaspoonful (1.25 to 2.5 mL) every 4 to 6 hours.

What interacts with Promethazine Hydrochloride and Phenylephrine Hydrochloride?

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What are the warnings of Promethazine Hydrochloride and Phenylephrine Hydrochloride?

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What are the precautions of Promethazine Hydrochloride and Phenylephrine Hydrochloride?

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What are the side effects of Promethazine Hydrochloride and Phenylephrine Hydrochloride?

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

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.

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).

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

How should I store and handle Promethazine Hydrochloride and Phenylephrine Hydrochloride?

Storage ConditionsStore at or below 25°C (77°F); however, brief exposure up to 40°C (104°F) does not adversely affect the product. Avoid excessive heat. Protect from freezing. Protect from light. Keep out of reach of children.Sterile, Nonpyrogenic, Preservative-free, PVC-free, DEHP-free.The container and container closure are not made with natural rubber latex.Storage ConditionsStore at or below 25°C (77°F); however, brief exposure up to 40°C (104°F) does not adversely affect the product. Avoid excessive heat. Protect from freezing. Protect from light. Keep out of reach of children.Sterile, Nonpyrogenic, Preservative-free, PVC-free, DEHP-free.The container and container closure are not made with natural rubber latex.Storage ConditionsStore at or below 25°C (77°F); however, brief exposure up to 40°C (104°F) does not adversely affect the product. Avoid excessive heat. Protect from freezing. Protect from light. Keep out of reach of children.Sterile, Nonpyrogenic, Preservative-free, PVC-free, DEHP-free.The container and container closure are not made with natural rubber latex.Storage ConditionsStore at or below 25°C (77°F); however, brief exposure up to 40°C (104°F) does not adversely affect the product. Avoid excessive heat. Protect from freezing. Protect from light. Keep out of reach of children.Sterile, Nonpyrogenic, Preservative-free, PVC-free, DEHP-free.The container and container closure are not made with natural rubber latex.Storage ConditionsStore at or below 25°C (77°F); however, brief exposure up to 40°C (104°F) does not adversely affect the product. Avoid excessive heat. Protect from freezing. Protect from light. Keep out of reach of children.Sterile, Nonpyrogenic, Preservative-free, PVC-free, DEHP-free.The container and container closure are not made with natural rubber latex.Storage ConditionsStore at or below 25°C (77°F); however, brief exposure up to 40°C (104°F) does not adversely affect the product. Avoid excessive heat. Protect from freezing. Protect from light. Keep out of reach of children.Sterile, Nonpyrogenic, Preservative-free, PVC-free, DEHP-free.The container and container closure are not made with natural rubber latex.Storage ConditionsStore at or below 25°C (77°F); however, brief exposure up to 40°C (104°F) does not adversely affect the product. Avoid excessive heat. Protect from freezing. Protect from light. Keep out of reach of children.Sterile, Nonpyrogenic, Preservative-free, PVC-free, DEHP-free.The container and container closure are not made with natural rubber latex.This preparation is a yellow-orange colored, fruit flavored syrup. Each 5 mL (one teaspoonful) contains promethazine hydrochloride 6.25 mg, phenylephrine hydrochloride 5 mg, and alcohol 7 percent, and is available in bottles of 4 fl. oz. (118 mL) and 16 fl. oz. (473 mL).Keep 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 11701Made in U.S.A.Rev. 802:01 08/16This preparation is a yellow-orange colored, fruit flavored syrup. Each 5 mL (one teaspoonful) contains promethazine hydrochloride 6.25 mg, phenylephrine hydrochloride 5 mg, and alcohol 7 percent, and is available in bottles of 4 fl. oz. (118 mL) and 16 fl. oz. (473 mL).Keep 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 11701Made in U.S.A.Rev. 802:01 08/16This preparation is a yellow-orange colored, fruit flavored syrup. Each 5 mL (one teaspoonful) contains promethazine hydrochloride 6.25 mg, phenylephrine hydrochloride 5 mg, and alcohol 7 percent, and is available in bottles of 4 fl. oz. (118 mL) and 16 fl. oz. (473 mL).Keep 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 11701Made in U.S.A.Rev. 802:01 08/16This preparation is a yellow-orange colored, fruit flavored syrup. Each 5 mL (one teaspoonful) contains promethazine hydrochloride 6.25 mg, phenylephrine hydrochloride 5 mg, and alcohol 7 percent, and is available in bottles of 4 fl. oz. (118 mL) and 16 fl. oz. (473 mL).Keep 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 11701Made in U.S.A.Rev. 802:01 08/16This preparation is a yellow-orange colored, fruit flavored syrup. Each 5 mL (one teaspoonful) contains promethazine hydrochloride 6.25 mg, phenylephrine hydrochloride 5 mg, and alcohol 7 percent, and is available in bottles of 4 fl. oz. (118 mL) and 16 fl. oz. (473 mL).Keep 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 11701Made in U.S.A.Rev. 802:01 08/16This preparation is a yellow-orange colored, fruit flavored syrup. Each 5 mL (one teaspoonful) contains promethazine hydrochloride 6.25 mg, phenylephrine hydrochloride 5 mg, and alcohol 7 percent, and is available in bottles of 4 fl. oz. (118 mL) and 16 fl. oz. (473 mL).Keep 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 11701Made in U.S.A.Rev. 802:01 08/16This preparation is a yellow-orange colored, fruit flavored syrup. Each 5 mL (one teaspoonful) contains promethazine hydrochloride 6.25 mg, phenylephrine hydrochloride 5 mg, and alcohol 7 percent, and is available in bottles of 4 fl. oz. (118 mL) and 16 fl. oz. (473 mL).Keep 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 11701Made in U.S.A.Rev. 802:01 08/16This preparation is a yellow-orange colored, fruit flavored syrup. Each 5 mL (one teaspoonful) contains promethazine hydrochloride 6.25 mg, phenylephrine hydrochloride 5 mg, and alcohol 7 percent, and is available in bottles of 4 fl. oz. (118 mL) and 16 fl. oz. (473 mL).Keep 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 11701Made in U.S.A.Rev. 802:01 08/16This preparation is a yellow-orange colored, fruit flavored syrup. Each 5 mL (one teaspoonful) contains promethazine hydrochloride 6.25 mg, phenylephrine hydrochloride 5 mg, and alcohol 7 percent, and is available in bottles of 4 fl. oz. (118 mL) and 16 fl. oz. (473 mL).Keep 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 11701Made in U.S.A.Rev. 802:01 08/16

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Clinical Information

Chemical Structure

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Clinical Pharmacology

Promethazine:

Promethazine is a phenothiazine derivative which differs structurally from the antipsychotic phenothiazines by the presence of a branched side chain and no ring substitution. It is thought that this configuration is responsible for its relative lack (1/10 that of chlorpromazine) of dopamine antagonist properties.

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-demethylpromethazine are the predominant metabolites appearing in the urine.

Phenylephrine:

Phenylephrine is a potent postsynaptic-α-receptor agonist with little effect on β-receptors of the heart. Phenylephrine has no effect on β-adrenergic receptors of the bronchi or peripheral blood vessels. A direct action at receptors accounts for the greater part of its effects, only a small part being due to its ability to release norepinephrine.

Therapeutic doses of phenylephrine mainly cause vasoconstriction. Phenylephrine increases resistance and, to a lesser extent, decreases capacitance of blood vessels. Total peripheral resistance is increased, resulting in increased systolic and diastolic blood pressure. Pulmonary arterial pressure is usually increased, and renal blood flow is usually decreased. Local vasoconstriction and hemostasis occur following topical application or infiltration of phenylephrine into tissues. The main effect of phenylephrine on the heart is bradycardia; it produces a positive inotropic effect on the myocardium in doses greater than those usually used therapeutically. Rarely, the drug may increase the irritability of the heart, causing arrhythmias. Cardiac output is decreased slightly. Phenylephrine increases the work of the heart by increasing peripheral arterial resistance.

Phenylephrine has a mild central stimulant effect.

Following oral administration or topical application of phenylephrine to the mucosa, constriction of blood vessels in the nasal mucosa relieves nasal congestion associated with allergy or head colds. Following oral administration, nasal decongestion may occur within 15 or 20 minutes and may persist for up to 4 hours.

Phenylephrine is irregularly absorbed from and readily metabolized in the gastrointestinal tract. Phenylephrine is metabolized in the liver and intestine by monoamine oxidase. The metabolites and their route and rate of excretion have not been identified. The pharmacologic action of phenylephrine is terminated at least partially by uptake of the drug into tissues.

Non-Clinical Toxicology

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.

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).

Promethazine

CNS Depressants:

Epinephrine:

Anticholinergics:

Monoamine oxidase inhibitors (MAOI):

Phenylephrine

Animal reproduction studies have not been conducted with the drug combination–promethazine and phenylephrine. 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 phenylephrine 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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Professional

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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