Šalis: Jungtinės Valstijos
kalba: anglų
Šaltinis: NLM (National Library of Medicine)
PROMETHAZINE HYDROCHLORIDE (UNII: R61ZEH7I1I) (PROMETHAZINE - UNII:FF28EJQ494)
Proficient Rx LP
ORAL
PRESCRIPTION DRUG
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
Promethazine hydrochloride tablets USP, 25 mg are, white to off-white, round shape, biconvex, uncoated tablets debossed with the quadrisect and the logo of "Z", "C", "0" and "2" on one side and plain on the other side and are supplied as follows: NDC 71205-658-10 in bottle of 10 tablets NDC 71205-658-12 in bottle of 12 tablets NDC 71205-658-20 in bottle of 20 tablets NDC 71205-658-30 in bottle of 30 tablets NDC 71205-658-60 in bottle of 60 tablets NDC 71205-658-90 in bottle of 90 tablets Keep tightly closed. Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Protect from light. Dispense in light-resistant, tight container. Manufactured by: Cadila Healthcare Ltd., India. For BluePoint Laboratories Repackaged by: Proficient Rx LP Thousand Oaks, CA 91320 Rev.: 10/13
Abbreviated New Drug Application
Proficient Rx LP ---------- Patient Information Leaflet Promethazine Hydrochloride Tablets, USP Rx only This is a summary of the most important information about promethazine. For details, talk to your healthcare professional. WHAT IS PROMETHAZINE? Promethazine is an antihistamine which can be taken by mouth as a tablet or syrup, rectally as a suppository, or by injection. It can be used for: • "hay fever," or, a stuffy runny nose from allergy • watery, itchy eyes due to inhaled allergies and foods • mild allergic skin reactions with itching and swelling • allergic reactions to blood or plasma • dermographism, a form of hives known as "skin writing" • serious allergic reactions along with epinephrine and other treatments • sedation before or after surgery, or during childbirth • prevention and control of nausea and vomiting after surgery • along with meperidine (demerol) or other pain medicines • sedation, relief of anxiety, and production of light sleep • from which the patient can be easily aroused • treatment and prevention of motion sickness WHO SHOULD NOT USE PROMETHAZINE? Promethazine should not be given to: • children under two years of age • patients who are unconscious • patients who are allergic to promethazine, any of the ingredients in promethazine, or to other phenothiazines • patients with lung symptoms including asthma • children who are vomiting unless the vomiting is prolonged and there is a known cause WHAT ARE THE RISKS? The following are the major potential risks and side effects of promethazine therapy. However, this list is not complete. • Severe drowsiness and reduced mental alertness. Promethazine may cause drowsiness which may impair your ability to ride a bike, drive a car, or operate machinery. This may be worsened if taken with alcohol or other drugs that also cause central nervous system (CNS) slowing such as sedatives, pain medicines, tranquilizers or certain drugs for depression. • Serious breathing problems. Promethazine should not be used in p Perskaitykite visą dokumentą
PROMETHAZINE HYDROCHLORIDE- PROMETHAZINE HYDROCHLORIDE TABLET PROFICIENT RX LP ---------- PROMETHAZINE HYDROCHLORIDE TABLETS, USP RX ONLY DESCRIPTION Each tablet of promethazine hydrochloride contains 25 mg promethazine hydrochloride. The inactive ingredients present are hydroxypropyl cellulose, lactose monohydrate, low- substituted hydroxypropyl cellulose and magnesium stearate. Promethazine hydrochloride is a racemic compound; the molecular formula is C H N S·HCl and its molecular weight is 320.88. Promethazine hydrochloride, a phenothiazine derivative, is designated chemically as _10H_-Phenothiazine-10-ethanamine, _N_, _N_,α-trimethyl-, monohydrochloride, (±)- with the following structural formula: 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 freely soluble in water, in hot dehydrated alcohol, and in chloroform; practically insoluble in ether, in acetone and in ethyl acetate. CLINICAL PHARMACOLOGY 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. 17 20 2 1 INDICATIONS AND USAGE Promethazine Hydrochloride, is useful orally for: Perennial and seasonal allergic rhinitis. Vasom Perskaitykite visą dokumentą