Promethazine HCl Side Effects

Severe side effects of Promethazine HCI

Respiratory Failure, with increased risk for pediatric and geriatric patients
Drastic change in blood pressure
Irregular Heartbeat
Neuroleptic Malignant Syndrome, which may be fatal if not treated immediately.

Common side effects of Promethazine HCI

Gastrointestinal side effects such as constipation, nausea, and vomiting.
Restlessness (especially during withdrawal), short temper, and other mood problems may occur.
Chest Pressure
Feelings of elevated euphoria, especially when taken in combination with opioids.

Warnings & Recalls for Promethazine HCl

Black Box Warnings

Promethazine should not be administered to children under 2 years old as it may cause fatal respiratory depression. Caution should be observed when administering Promethazine HCl to pediatric patients due to an increased risk of respiratory failure.
Observe caution when administering a promethazine hydrochloride injection. The drug may cause severe tissue damage or gangrene if injected into an artery or under the skin. Amputation may be necessary in extreme situations. If injected intravenously, there is a risk that the medication may escape from the vein and into the surrounding tissue. Therefore, the FDA suggests that Promethazine should be injected deep in the muscle to minimize risk.

Recalls

On June 1st, 2011, Aidapak Services, LLC issued a recall for Promethazine HCl 25 mg tablets due to penicillin cross-contamination. The recall number is D-191-2012. For a list of of the recalled lots, see 190) on the FDA Enforcement Report for November 23rd, 2011.
On November 26, 2008, Advantage Dose LLC issued a recall for Promethazine (generic Phenergan) 6.25MG/5ML liquid in 10 ml bottles due to non compliance with cGMP (current good manufacturing practices). The NDC is 50432-0508-04 and the recall number is D-817-2009. The recalled lot number is lot 29146A and and the expiration date is 04/23/09.

Warnings

Consult your physician before taking Promethazine HCl if you have asthma, sleep apnea, or any chronic breathing problems. As with other antihistamines, Promethazine HCl is contraindicated for use by asthma patients.
Promethazine may interfere with the abilities required for hazardous tasks such as operating dangerous machinery or driving. This effect may be intensified when Promethazine is combined with alcohol, barbiturates, and narcotics. Observe caution and know how the medication effects you before undergoing dangerous tasks.

Promethazine HCl Treatment and Use

Promethazine HCl | Phenergan is an antihistamine in the phenothiazine class primarily used to treat allergic reactions, such as anaphylactic shock, as well as nausea and vomiting. It is also prescribed for motion sickness. It is often used as an alternative to Benadryl for allergic reactions.

How does Promethazine HCl work?

Promethazine targets and neutralizes the effects of excess histamine- a chemical produced by allergic reactions- by blocking h1 receptors and preventing histamine from binding to them. This prevents the occurrence of symptoms of allergic reactions, such as itchiness or runny nose. Promethazine has also been shown to work effectively as a sedative.

Dosage

Promethazine HCl is available in a variety of forms including 12.5, 25, and 50 mg tablets as well as IV, oral liquid, and suppositories. The initial dose for allergic reactions, anaphylaxis, motion sickness, and nausea is 25 mg a day or 12.5 mg twice a day.

Other Names for Promethazine HCl

Brand names

Phenergan

Promethegan

Phenadoz

Atosil

Avomine

Receptozine

Generic name

Promethazine Hydrochloride