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NA | Promethazine Hydrochloride [Northwind Pharmaceuticals] | BioPortfolio

12:37 EST 27th January 2019 | BioPortfolio

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NDC: 51655-112-10

MFG: 68382-040-01

Promethazine Hydrochloride 12.5 MG

10 Tablets

Rx Only

Dosage: See package insert

Store at 68 to 77 degrees F.

Keep out of the reach of children.

Each tablet contains: Promethazine Hydrochloride, USP...12.5mg

Mfg: by Cadila Healthcare Ltd. India

Dist. By: Zydus Pharmaceuticals USA Inc. Pennington, NJ 08534

Repackaged by Northwind Pharmaceuticals, Indianapolis, IN 46256

Lot#

Exp. Date:

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 H1 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.

Promethazine Hydrochloride, is useful orally for Perennial and seasonal allergic rhinitis.

Vasomotor rhinitis.

Allergic conjunctivitis due to inhalant allergens and foods.

Mild, uncomplicated allergic skin manifestations of urticaria and angioedema.

Amelioration of allergic reactions to blood or plasma.

Dermographism.

Anaphylactic reactions, as adjunctive therapy to epinephrine and other standard measures, after the acute manifestations have been controlled.

Preoperative, postoperative, or obstetric sedation.

Prevention and control of nausea and vomiting associated with certain types of anesthesia and surgery.

Therapy adjunctive to meperidine or other analgesics for control of post-operative pain.

Sedation in both children and adults, as well as relief of apprehension and production of light sleep from which the patient can be easily aroused.

Active and prophylactic treatment of motion sickness.

Antiemetic therapy in postoperative patients.

Promethazine hydrochloride tablets, USP are contraindicated for use in pediatric patients less than two years of age.Promethazine hydrochloride tablets, USP are 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

CNS Depressants - Promethazine hydrochloride tablets, USP may increase, prolong, or intensify the sedative action of other central-nervous-system depressants, such as alcohol, sedatives/hypnotics (including 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 hydrochloride. When given concomitantly with promethazine hydrochloride tablets, USP 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 hydrochloride 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 - Because of the potential for promethazine hydrochloride to reverse epinephrine's vasopressor effect, epinephrine should NOT be used to treat hypotension associated with promethazine hydrochloride tablets, USP overdose.

Anticholinergics - Concomitant use of other agents with anticholinergic properties should be undertaken with caution.

Monoamine Oxidase Inhibitors (MAOI) - Drug interactions, including an increased incidence of extrapyramidal effects, have been reported when some MAOI and phenothiazines are used concomitantly. This possibility should be considered with promethazine hydrochloride tablets, USP.

Manufacturer

Northwind Pharmaceuticals

Active Ingredients

Source

Drugs and Medications [437 Associated Drugs and Medications listed on BioPortfolio]

Promethazine hydrochloride [direct rx]

PROMETHAZINE HYDROCHLORIDE 25mg

Promethazine hydrochloride [direct rx]

PROMETHAZINE HYDROCHLORIDE 25mg

Promethazine hydrochloride [northwind pharmaceuticals]

NA

Promethazine hcl [cantrell drug company]

Promethazine HCl 0.625 mg/mL in 0.9% Sodium Chloride 10 mL Syringe

Promethazine hcl [cantrell drug company]

Promethazine HCl 12.5 mg Added to 0.9% Sodium Chloride 25 mL Bag

Clinical Trials [2212 Associated Clinical Trials listed on BioPortfolio]

TREC-Lebanon: A Trial for Rapid Tranquilisation for Agitated Patients in the Emergency Setting

This is a randomised controlled trial comparing haloperidol + promethazine versus haloperidol + promethazine + chlorpromazine for agitated patients in the emergency department.

To Demonstrate the Relative Bioavailability Study of Promethazine HCl 50 mg Tablets Under Fasting Conditions

To demonstrate the relative bioavailability study of Promethazine HCl 50 mg tablets under fasting conditions.

Comparison of Ondansetron, Metoclopramide and Promethazine for the Treatment of Nausea and Vomiting in the Adult ED

The purpose of this study is to compare the effectiveness of ondansetron, metoclopramide, and promethazine for the treatment of nausea in the adult emergency department population. We hyp...

Efficacy of Low Dose Promethazine for Postoperative Nausea and Vomiting

There has been an increase in ambulatory surgical procedures performed across Canada; ambulatory procedures account for almost 70% of all surgeries. Postoperative nausea and vomiting (PON...

Does Thiamine Help Vomiting and Nausea in Pregnancy?

There are different treatments for nausea and vomiting in pregnancy. According to the ACOG recommendations, promethazine is the first line of parenteral treatment after oral treatment had ...

PubMed Articles [208 Associated PubMed Articles listed on BioPortfolio]

Biophysical investigation of promethazine hydrochloride binding with micelles of biocompatible gemini surfactants: Combination of spectroscopic and electrochemical analysis.

Knowledge of binding parameters for drug and surfactant complexations is crucially vital in order to design effective drug carrier systems with requisite features. To this end, this work was designed ...

Protective effects of berberine hydrochloride on DSS-induced ulcerative colitis in rats.

Berberine hydrochloride is one the effective compound among Rhizoma Coptidis, Cortex Phellodendri, and other plants. There are several clinical functions of berberine hydrochloride including anti-infl...

In vitro and in vivo performance of epinastine hydrochloride-releasing contact lenses.

A number of drug-releasing contact lenses are currently being studied to address issues inherent in eye drops as a drug delivery method. In this study, we developed epinastine hydrochloride-releasing ...

Prevention of Opioid-Induced Nausea and Vomiting During Treatment of Moderate to Severe Acute Pain: A Randomized Placebo-Controlled Trial Comparing CL-108 (Hydrocodone 7.5 mg/Acetaminophen 325 mg/Rapid-Release, Low-Dose Promethazine 12.5 mg) with Conventional Hydrocodone 7.5 mg/Acetaminophen 325 mg.

To evaluate the prevention of opioid-induced nausea and vomiting (OINV) and the relief of moderate to severe acute pain by CL-108, a novel drug combining a low-dose antiemetic (rapid-release promethaz...

In vitro and ex vivo studies on Diltiazem hydrochloride-loaded microsponges in rectal gels for chronic anal fissures treatment.

Diltiazem hydrochloride, topically applied at 2% concentration, is considered effective for the treatment of chronic anal fissures, althought it involves several side effects among which anal pruritus...

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