FDA BLACK BOX WARNING
Phenergan 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 phenergan in pediatric patients less than 2 years of age. A wide range of weight-based doses of phenergan have resulted in respiratory depression in these patients.
Caution should be exercised when administering phenergan to pediatric patients 2 years of age and older. It is recommended that the lowest effective dose of phenergan be used in pediatric patients 2 years of age and older and concomitant administration of other drugs with respiratory depressant effects be avoided.
[09/16/2009] FDA is requiring a Boxed Warning for promethazine hydrochloride injection, USP products to better communicate the risks of severe tissue injury associated with administration of this drug. Perivascular extravasation, unintentional intra-arterial injection and intraneuronal or perineuronal infiltration of the drug may result in irritation and tissue damage, including gangrene. The Boxed Warning will remind practitioners that due to the risks of intravenous injection, the preferred route of administration is deep intramuscular injection and that subcutaneous injection is contraindicated.
This action is based on FDA’s analysis of post-marketing reports of severe tissue injury, including gangrene, requiring amputation following intravenous administration of promethazine as well as FDA’s review of the current prescribing information for these products. FDA has determined that the presentation, organization, and content of the prescribing information should be revised to more effectively communicate the risk of severe tissue injury following intravenous administration.
In addition to the Boxed Warning, FDA is requiring a revision to the Dosage and Administration section to increase the visibility and accessibility of specific recommendations for the maximum concentration (25 mg per mL) and rate of administration (25 mg per minute) when intravenous administration of promethazine is required.
FDA is requiring the changes to the prescribing information under the authorities granted to FDA by the Food and Drug Administration Amendments Act (FDAAA) of 2007.
Promethazine hydrochloride injection, USP is approved for a variety of uses including allergic reactions, sedation, motion sickness, nausea, and vomiting associated with anesthesia and surgery, and as an adjunct to analgesics for control of postoperative pain.
Increased Mortality in Elderly Patients With Dementia-Related Psychosis Seen With Prochlorperazine
Elderly patients with dementia-related psychosis treated with antipsychotic drugs are at an increased risk of death. Analyses of seventeen placebo-controlled trials (modal duration of 10 weeks), largely in patients taking atypical antipsychotic drugs, revealed a risk of death in drug-treated patients of between 1.6 to 1.7 times the risk of death in placebo-treated patients. Over the course of a typical 10 week controlled trial, the rate of death in drug-treated patients was about 4.5%, compared to a rate of about 2.6% in the placebo group. Although the causes of death were varied, most of the deaths appeared to be either cardiovascular (e.g., heart failure, sudden death) or infectious (e.g., pneumonia) in nature. Observational studies suggest that, similar to atypical antipsychotic drugs, treatment with conventional antipsychotic drugs may increase mortality. The extent to which the findings of increased mortality in observational studies may be attributed to the antipsychotic drug as opposed to some characteristic(s) of the patients is not clear. COMPAZINE® (prochlorperazine maleate tablets USP) is not approved for the treatment of patients with dementia-related psychosis.
These drugs may make you sweat less, causing your body temperature to increase. Use extra care not to become overheated during exercise or in hot weather while you are taking one of these medications, since overheating may result in heatstroke. Also, hot baths or saunas may make you feel dizzy or faint when you are taking these medications.
Warning: Special Mental and Physical Adverse Effects
Older adults are especially sensitive to the harmful anticholinergic effects of these drugs. Drugs in this family should not be used unless absolutely necessary.
Mental Effects: confusion, delirium, short-term memory problems, disorientation and impaired attention
Physical Effects: dry mouth, constipation, difficulty urinating (especially for a man with an enlarged prostate), blurred vision, decreased sweating with increased body temperature, sexual dysfunction and worsening of glaucoma
Dietary Steps to Manage Nausea Induced by Cancer Drugs
Drugs used to treat cancer often cause severe nausea and vomiting, either immediately after the drug is taken or several hours later. You can treat this kind of nausea and vomiting by changing your diet or by taking an antinausea drug. You should always try dietary changes first.
Eat small, frequent meals so that your stomach is never empty.
When you get up from sleeping or resting, eat some dry crackers or toast before you start being active.
Drink carbonated drinks or other clear liquids such as soups and gelatin.
Eat tart foods such as lemons and pickles.
Do not eat foods with strong smells.
Sensitivity to Cold
Drugs such as chlorpromazine (THORAZINE), fluphenazine (PROLIXIN), prochlorperazine (COMPAZINE), thioridazine (Mellaril), and trifluoperazine (STELAZINE) may make you more sensitive to cold temperatures. Dress warmly during cold weather. Be careful during prolonged exposure to cold, such as in winter sports or swimming in cold water.