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Basic Drug Info
Drug Name:Promethazine hydrochloride
Manufacturer:Watson Laboratories, Inc.
Other Info:



Clinical Trials:


Indications and Usage
Promethazine hydrochloride tablets are useful 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 postoperative 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.
Hay fever -- seasonal variety of allergic rhinitis, marked by acute conjunctivitis with lacrimation and itching; regarded as an allergic condition triggered by specific allergens.

VASOMOTOR RHINITIS -- A form of non-allergic rhinitis that is characterized by nasal congestion and posterior pharyngeal drainage.

Allergic Conjunctivitis -- Conjunctivitis due to hypersensitivity to various allergens.

Urticaria -- A vascular reaction of the skin characterized by erythema and wheal formation due to localized increase of vascular permeability. The causative mechanism may be allergy, infection, or stress.

Angioedema -- Swelling involving the deep DERMIS, subcutaneous, or submucosal tissues, representing localized EDEMA. Angioedema often occurs in the face, lips, tongue, and larynx.

Allergic Reaction --

Dermatographic urticaria --

Sedation --

Nausea -- An unpleasant sensation in the stomach usually accompanied by the urge to vomit. Common causes are early pregnancy, sea and motion sickness, emotional stress, intense pain, food poisoning, and various enteroviruses.

Vomiting -- The forcible expulsion of the contents of the STOMACH through the MOUTH.

Absence of sensation --

Pain, Postoperative -- Pain during the period after surgery.

Motion Sickness -- Disorder caused by motion, as sea sickness, train sickness, car sickness, air sickness, or SPACE MOTION SICKNESS. It may include nausea, vomiting and dizziness.

Contraindications
Promethazine hydrochloride tablets are contraindicated for use in pediatric patients less than two years of age.Promethazine hydrochloride tablets 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.
Hypersensitivity -- Altered reactivity to an antigen, which can result in pathologic reactions upon subsequent exposure to that particular antigen.

Symptoms -- An indication that a person has a condition or disease. Some examples of symptoms are headache, fever, fatigue, nausea, vomiting, and pain.

Asthma -- A form of bronchial disorder with three distinct components: airway hyper-responsiveness (RESPIRATORY HYPERSENSITIVITY), airway INFLAMMATION, and intermittent AIRWAY OBSTRUCTION. It is characterized by spasmodic contraction of airway smooth muscle, WHEEZING, and dyspnea (DYSPNEA, PAROXYSMAL).

Warnings

PROMETHAZINE HYDROCHLORIDE TABLETS USP 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.
Branded Drugs
The following US Branded drugs contain Promethazine hydrochloride


PHENERGAN VC W/ CODEINE -- ANI PHARMACEUTICALS INC

PHERAZINE VC W/ CODEINE -- HALSEY DRUG CO INC

PROMETH HYDROCHLORIDE,PHENYLEPHRINE HYDROCHLORIDE W/CODEINE PHOSPHATE -- VINTAGE PHARMACEUTICALS LLC

PROMETH VC W/ CODEINE -- ACTAVIS MID ATLANTIC LLC

PROMETHAZINE VC W/ CODEINE -- HR CENCI LABORATORIES INC

PROMETHAZINE VC W/ CODEINE -- MORTON GROVE PHARMACEUTICALS INC

PHENERGAN W/ CODEINE -- ANI PHARMACEUTICALS INC

PHERAZINE W/ CODEINE -- HALSEY DRUG CO INC

PROMETH W/ CODEINE -- ACTAVIS MID ATLANTIC LLC

PROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE -- HI TECH PHARMACAL CO INC

PROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE -- PHARMACEUTICAL ASSOC INC DIV BEACH PRODUCTS

PROMETHAZINE W/ CODEINE -- HR CENCI LABORATORIES INC

PROMETHAZINE W/ CODEINE -- MORTON GROVE PHARMACEUTICALS INC

PROMETHAZINE WITH CODEINE -- VINTAGE PHARMACEUTICALS LLC

PHERAZINE DM -- HALSEY DRUG CO INC

PROMETH W/ DEXTROMETHORPHAN -- ACTAVIS MID ATLANTIC LLC

PROMETHAZINE DM -- VINTAGE PHARMACEUTICALS LLC

PROMETHAZINE HYDROCHLORIDE AND DESTROMETHORPHAN HYDROBROMIDE -- ANI PHARMACEUTICALS INC

PROMETHAZINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE -- HI TECH PHARMACAL CO INC

PROMETHAZINE W/ DEXTROMETHORPHAN -- MORTON GROVE PHARMACEUTICALS INC

MEPERGAN -- BAXTER HEALTHCARE CORP ANESTHESIA CRITICAL CARE

PHENERGAN VC -- ANI PHARMACEUTICALS INC

PHENYLEPHRINE HYDROCHLORIDE AND PROMETHAZINE HYDROCHLORIDE -- VINTAGE PHARMACEUTICALS LLC

PHERAZINE VC -- HALSEY DRUG CO INC

PROMETH VC PLAIN -- ACTAVIS MID ATLANTIC LLC

PROMETHAZINE VC PLAIN -- HR CENCI LABORATORIES INC

PROMETHAZINE VC PLAIN -- MORTON GROVE PHARMACEUTICALS INC

PHENERGAN -- WYETH AYERST LABORATORIES

ZIPAN-25 -- ALTANA INC

ZIPAN-50 -- ALTANA INC

PHENERGAN -- WYETH PHARMACEUTICALS INC

PROMETHACON -- POLYMEDICA INDUSTRIES INC

PROMETHEGAN -- G AND W LABORATORIES INC

MYMETHAZINE FORTIS -- USL PHARMA INC

PROMETH FORTIS -- ALPHARMA US PHARMACEUTICALS DIVISION

PROMETH PLAIN -- ACTAVIS MID ATLANTIC LLC

PROMETHAZINE -- HR CENCI LABORATORIES INC

PROMETHAZINE HYDROCHLORIDE PLAIN -- ANI PHARMACEUTICALS INC

PROMETHAZINE PLAIN -- MORTON GROVE PHARMACEUTICALS INC

REMSED -- BRISTOL MYERS SQUIBB PHARMA CO


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