Promethazine

Pregnancy category: C

Lactation: Not known whether drug crosses into breast milk; discontinue drug, or do not nurse

Pregnancy Categories

A:Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.

B:May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.

C:Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.

D:Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.

X:Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.

NA:Information not available.

Promethazine can cause side effects that may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be awake and alert. Avoid getting up too fast from a sitting or lying position, or you may feel dizzy. Get up slowly and steady yourself to prevent a fall.

Avoid drinking alcohol. It can increase some of the side effects of promethazine.

Avoid exposure to sunlight or tanning beds. Promethazine can make your skin more sensitive to sunlight, and a sunburn may result. Wear sunscreen (SPF 15 or higher) and protective clothing if you must be outdoors.

Promethazine is a prescription medication used to treat symptoms of allergic reactions, such as:

• rhinitis (sneezing, stuffy or runny nose)
• itchy & watery eyes
• skin irritation, such as swelling or hives

Promethazine is also used for:

• prevention or treatment of nausea & vomiting, including nausea & vomiting after surgery
• prevention or treatment of motion sickness
• sedation (to calm or encourage light sleeping)

Promethazine is part of the drug class:

• Phenothiazine derivatives

Medicines can interact with certain foods.  In some cases, this may be harmful and your doctor may advise you to avoid certain foods.  In the case of promethazine, there are no specific foods that you must exclude from your diet when receiving promethazine.

Store promethazine rectal suppositories in a refrigerator between 36 - 46°F.

To report SUSPECTED ADVERSE REACTIONS, contact Hi-Tech Pharmacal Co., Inc. at 1-800-262-9010 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Central Nervous System

Drowsiness is the most prominent CNS effect of this drug. Sedation, somnolence, blurred vision, dizziness; confusion, disorientation, and extrapyramidal symptoms such as oculogyric crisis, torticollis, and tongue protrusion; lassitude, tinnitus, incoordination, fatigue, euphoria, nervousness, diplopia, insomnia, tremors, convulsive seizures, excitation, catatonic-like states, hysteria. Hallucinations have also been reported.

Cardiovascular

Increased or decreased blood pressure, tachycardia, bradycardia, faintness.

Dermatologic

Dermatitis, photosensitivity, urticaria. Hematologic–Leukopenia, thrombocytopenia, thrombocytopenic purpura, agranulocytosis.

Gastrointestinal

Dry mouth, nausea, vomiting, jaundice.

Respiratory

Asthma, nasal stuffiness, respiratory depression (potentially fatal) and apnea (potentially fatal). (See WARNINGS - Respiratory Depression.)

Other

Angioneurotic edema. Neuroleptic malignant syndrome (potentially fatal) has also been reported. (See WARNINGS - Neuroleptic Malignant Syndrome.)

Paradoxical Reactions

Hyperexcitability and abnormal movements have been reported in patients following a single administration of Promethazine HCl. Consideration should be given to the discontinuation of Promethazine HCl and to the use of other drugs if these reactions occur. Respiratory depression, nightmares, delirium, and agitated behavior have also been reported in some of these patients.

Promethazine HYDROCHLORIDE ORAL SOLUTION USP,

6.25 mg/5 mL

Each 5 mL (teaspoonful) contains:

Promethazine Hydrochloride ………….. 6.25 mg

Alcohol …………………………………….. 7%

USUAL DOSAGE: See package insert for full prescribing information.

Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].

Protect from light. Dispense in a tight, light-resistant container, as defined in the USP.

16 fl oz (473 mL)

Hi-Tech Pharmacal Co., Inc.

Amityville, NY 11701

Parenteral: IV: Although IV administration should be avoided, promethazine has been administered IV in select patients. Solution for injection may be administered at a maximum concentration of 25 mg/mL; however, to minimize phlebitis further dilution is recommended. Some have suggested further diluting the 25 mg/mL with 10 to 20 mL NS (ISMP 2006).

Oral: Administer with food, water, or milk to decrease GI distress. Measure and administer prescribed dose of oral solution using dosing syringe, dosing spoon, or dosing cup.

Parenteral: Not for SubQ administration; promethazine is a chemical irritant which may produce necrosis.

IM: Preferred route of administration; administer as a deep IM injection

IV: IV use should be avoided when possible since severe tissue damage has occurred with IV administration; in selected patients, promethazine has been diluted and infused at a maximum rate of 25 mg/minute. To minimize phlebitis, consider administering over 10 to 15 minutes, limiting initial dose to 1/4 or 1/2 the usual dose (eg, in adults 6.25 to 12.5 mg), further diluting the 25 mg/mL strength in 10 to 20 mL NS, and administering through a large bore vein (not hand or wrist) or via a running IV line at port farthest from patient's vein (ISMP 2006).

Vesicant; ensure proper needle or catheter placement prior to and during infusion; avoid extravasation. Discontinue immediately if burning or pain occurs with administration; evaluate for inadvertent arterial injection or extravasation.

Extravasation management: If extravasation occurs, stop infusion immediately and disconnect (leave cannula/needle in place); gently aspirate extravasated solution (do NOT flush the line); remove needle/cannula; elevate extremity. Apply dry cold compresses (Hurst 2004).

Increase dietary intake of riboflavin.