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.
Promethazine 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 plain,
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.
