BOX WARNING WARNING
THE COMBINATION OF PROMETHAZINE HYDROCHLORIDE, PHENYLEPHRINE HYDROCHLORIDE AND CODEINE PHOSPHATE IS CONTRAINDICATED IN PEDIATRIC PATIENTS LESS THAN 16 YEARS OF AGE. CONCOMITANT ADMINISTRATION OF PROMETHAZINE PRODUCTS WITH OTHER RESPIRATORY DEPRESSANTS HAS AN ASSOCIATION WITH RESPIRATORY DEPRESSION, AND SOMETIMES DEATH, IN PEDIATRIC PATIENTS.
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.
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SUMMARY
Each 5 mL (one teaspoonful), for oral administration contains: Codeine phosphate 10 mg; promethazine hydrochloride 6.25 mg; phenylephrine hydrochloride 5 mg. Codeine is one of the naturally occurring phenanthrene alkaloids of opium derived from the opium poppy; it is classified pharmacologically as a narcotic analgesic. Promethazine hydrochloride, a phenothiazine derivative. Phenylephrine hydrochloride is a sympathomimetic amine salt.
Promethazine HCl, phenylephrine HCl and codeine phosphate syrup is indicated for the temporary relief of coughs and upper respiratory symptoms, including nasal congestion, associated with allergy or the common cold.
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NEWS HIGHLIGHTS
Clinical Trials Related to Promethazine, Phenylephrine and Codeine (Promethazine / Phenylephrine / Codeine)
Improving Safety of Antivenom in People Bitten by Snakes [Completed]
A study to increase the safety of polyvalent antivenom involving 1000 patients in three
centres: low dose adrenaline, promethazine, & hydrocortisone (alone and in combination) to
prevent acute adverse reactions to antivenom in people bitten by snakes: randomised, double
blind, placebo-controlled trial.
Four Interventions in the Management of Psychomotor Agitation, Safety and Efficacy Evaluation [Completed]
Prevention of Narcotic-Induced Nausea [Terminated]
We are doing this study to find out if extra medicine is needed to avoid the chance of
nausea sometimes linked to narcotic pain medicine (for example, morphine, dilaudid,
fentanyl). Some doctors always give medicine to prevent the possible side effect of nausea,
while others do not. We are looking to see if this extra medicine is helpful in preventing
nausea. The goal is to screen all patients with pain and enroll enough subjects to reach
our goal of 164 evaluable study participants.
Effect of Hyoscine and Promethazine on Labor Pain [Completed]
It is always considered to shorten the duration of delivery without compromising the mother
and fetus by obstetrics. Hyoscine and Promethazine are used widely in hospital and research
is very limited, with conflicting results regarding the efficacy of these two drugs. So the
investigators decided to compare of effect of hyoscine N-butyl bromide and Promethazine on
length of active phase of the first stage of labor.
Morphine Versus Morphine-promethazine Combination for Acute Low Back Pain Relief in the Adult Emergency Department [Not yet recruiting]
Acute low back pain is a common cause for emergency department visits. Controversy remains
regarding the optimal medication for acute low back pain relief. The investigators
hypothesized that administration of pharmacological anxiolysis in addition to analgesia will
improve pain relief and patient management in the emergency department.
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Page last updated: 2008-05-28
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