Specialist pharmaceutical company Mylan Inc (Nasdaq:MYL) reported on Friday the receipt of final approval from the US Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) for Promethazine
Hydrochloride (HCl) Tablets USP, 12.5 mg, 25 mg and 50 mg.
HCl Tablets are used to relieve the symptoms of certain allergic reactions, such as perennial and seasonal allergic rhinitis, Mylan added.
* PHYSICIAN'S DEFENSE The physician's return to the ED was proper because he handed over care to the critical care physician; promethazine
was not contraindicated; appropriate care was provided, including attempts at resuscitation.
Nonetheless, cases of severe tissue injury following IV administration of promethazine
continue to be reported.
Physicians also are being urged to exercise caution when administering promethazine
HCl medications to pediatric patients 2 years and older.
Added to the existing warning in the label was the statement, "Respiratory depression and apnea, sometimes associated with death, are strongly associated with promethazine
products and are not directly related to individualized weight-based dosing, which might otherwise permit safe administration."
The Food and Drug Administration has issued a safety warning to alert health care professionals that promethazine
HC1 in all forms, including syrup, is contraindicated in children younger than 2 years of age.
The list of potentially inappropriate drugs included: propoxyphene, indomethacin, pentazocine, methocarbamol, carisoprodol, oxybutynin, chlorzoxazone, metaxalone, cyclobenzaprine, flurazepam, amitriptyline, doxepin, meprobamate, lorazepam, oxazepam, alprazolam, temazepam, zolpidem, triazolain, chlordiazepoxide, diazepam, hydroxyzine, promethazine
, all barbiturates (except phenobarbital), and meperidine.
Options include topical benzocaine or analgesia with acetaminophen, a non-steroidal anti-inflammatory agent, or codeine plus promethazine
with or without additional acetaminophen.
4 Phenergan Elixir, PS4.49 for 100ml, www.expresschemist.co.uk Contains promethazine
, an antihistamine with gentle sedative properties.
"Our new product introductions such as promethazine
with codeine and promethazine
with DM are important contributors to our customers' bottom lines," says Edwin Berrios, Hi-Tech's vice president of sales and marketing.