PROMETHAZINE HYDROCHLORIDE injection

দেশ: মার্কিন যুক্তরাষ্ট্র

ভাষা: ইংরেজি

সূত্র: NLM (National Library of Medicine)

সক্রিয় উপাদান:

PROMETHAZINE HYDROCHLORIDE (UNII: R61ZEH7I1I) (PROMETHAZINE - UNII:FF28EJQ494)

থেকে পাওয়া:

Hikma Pharmaceuticals USA Inc.

INN (আন্তর্জাতিক নাম):

PROMETHAZINE HYDROCHLORIDE

রচনা:

PROMETHAZINE HYDROCHLORIDE 25 mg in 1 mL

প্রশাসন রুট:

INTRAMUSCULAR

প্রেসক্রিপশন টাইপ:

PRESCRIPTION DRUG

থেরাপিউটিক ইঙ্গিত:

Promethazine hydrochloride injection is indicated for the following conditions: - Amelioration of allergic reactions to blood or plasma. - In anaphylaxis as an adjunct to epinephrine and other standard measures after the acute symptoms have been controlled. - For other uncomplicated allergic conditions of the immediate type when oral therapy is impossible or contraindicated. - For sedation and relief of apprehension and to produce light sleep from which the patient can be easily aroused. - Active treatment of motion sickness. - Prevention and control of nausea and vomiting associated with certain types of anesthesia and surgery. - As an adjunct to analgesics for the control of postoperative pain. - Preoperative, postoperative, and obstetric (during labor) sedation. - Intravenously in special surgical situations, such as repeated bronchoscopy, ophthalmic surgery, and poor-risk patients, with reduced amounts of meperidine or other narcotic analgesic as an adjunct to anesthesia and analgesia. Promethazine hydrochloride injection is contraindicated for use in pediatric patients less than two years of age due to the risk of respiratory depression (see WARNINGS - Respiratory Depression ). Promethazine hydrochloride injection is contraindicated in comatose states. Under no circumstances should promethazine hydrochloride injection be given by intra-arterial injection due to the likelihood of severe arteriospasm and the possibility of resultant gangrene (see WARNINGS - Severe Tissue Injury, Including Gangrene ). Promethazine hydrochloride injection should not be given by the subcutaneous route because evidence of chemical irritation has been noted, and necrotic lesions have resulted following subcutaneous injection. The preferred parenteral route of administration is by deep intramuscular injection. Promethazine hydrochloride injection is contraindicated in patients who have demonstrated an idiosyncratic reaction or hypersensitivity to promethazine or other phenothiazines.

পণ্য সারাংশ:

Promethazine Hydrochloride Injection, USP is available as follows: 25 mg/mL        1 mL ampuls packaged in 25s (NDC 0641-1495-35) 50 mg/mL        1 mL ampuls packaged in 25s (NDC 0641-1496-35) Store at 20 ° to 25 °C (68 ° to 77 °F) [See USP Controlled Room Temperature]. Protect from light. Keep covered in carton until time of use. Do not use if solution has developed color or contains a precipitate.

অনুমোদন অবস্থা:

Abbreviated New Drug Application

পণ্য বৈশিষ্ট্য

PROMETHAZINE HYDROCHLORIDE- PROMETHAZINE HYDROCHLORIDE INJECTION
HIKMA PHARMACEUTICALS USA INC.
----------
PROMETHAZINE HYDROCHLORIDE INJECTION, USP
RX ONLY
WARNINGS
RESPIRATORY DEPRESSION – PEDIATRICS
PROMETHAZINE HYDROCHLORIDE INJECTION 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 IN
PEDIATRIC PATIENTS LESS THAN 2 YEARS OF AGE. CAUTION SHOULD BE
EXERCISED
WHEN ADMINISTERING PROMETHAZINE HYDROCHLORIDE INJECTION TO PEDIATRIC
PATIENTS 2 YEARS OF AGE AND OLDER (SEE WARNINGS - RESPIRATORY
DEPRESSION).
SEVERE TISSUE INJURY, INCLUDING GANGRENE
PROMETHAZINE HYDROCHLORIDE INJECTION CAN CAUSE SEVERE CHEMICAL
IRRITATION AND DAMAGE TO TISSUES REGARDLESS OF THE ROUTE OF
ADMINISTRATION. IRRITATION AND DAMAGE CAN RESULT FROM PERIVASCULAR
EXTRAVASATION, UNINTENTIONAL INTRA-ARTERIAL INJECTION, AND
INTRANEURONAL OR
PERINEURONAL INFILTRATION. ADVERSE REACTIONS INCLUDE BURNING, PAIN,
THROMBOPHLEBITIS, TISSUE NECROSIS, AND GANGRENE. IN SOME CASES,
SURGICAL
INTERVENTION, INCLUDING FASCIOTOMY, SKIN GRAFT, AND/OR AMPUTATION HAVE
BEEN REQUIRED (SEE WARNINGS - SEVERE TISSUE INJURY, INCLUDING
GANGRENE).
DUE TO THE RISKS OF INTRAVENOUS INJECTION, THE PREFERRED ROUTE OF
ADMINISTRATION OF PROMETHAZINE HYDROCHLORIDE INJECTION IS DEEP
INTRAMUSCULAR INJECTION. SUBCUTANEOUS INJECTION IS CONTRAINDICATED.
SEE
DOSAGE AND ADMINISTRATION FOR IMPORTANT NOTES ON ADMINISTRATION.
DESCRIPTION
Promethazine hydrochloride injection, USP is a sterile, pyrogen-free
solution for deep
intramuscular or intravenous administration. Promethazine
hydrochloride (10_H_-
Phenothiazine-10-ethanamine,_N,N,α_-trimethyl-, monohydrochloride,
(±)-) is a racemic
compound and has the following structural formula:
C
H
ClN S MW 320.88
Each mL contains promethazine hydrochloride, either 25 mg or 50 mg,
edetate disodium
0.1 mg, calcium chloride 0.04 mg, sodium metabisulfite 0.25 mg and
p