Promethazine HCl

DRUG DESCRIPTION

Promethazine hydrochloride is a racemic compound.

Promethazine hydrochloride, a phenothiazine derivative, is designated chemically as 10H-Phenothiazine-10-ethanamine, N,N,?-trimethyl-, monohydrochloride, (?)-with the following structural formula:

PROMETHAZINE HCL (promethazine hcl) Structural Formula  Illustration

C17H20N2SHCl M.W.320.88

Promethazine hydrochloride occurs as a white to faint yellow, practically odorless, crystalline powder which slowly oxidizes and turns blue on prolonged exposure to air. It is soluble in water and freely soluble in alcohol.

Each tablet, for oral administration, contains 25 mg or 50 mg of promethazine hydrochloride. In addition each tablet contains the following inactive ingredients: dibasic calcium phosphate, magnesium stearate, microcrystalline cellulose, sodium starch glycolate and stearic acid.

Promethazine Hydrochloride Tablets USP, 50 mg also contain anhydrous lactose.

What are the precautions when taking promethazine hydrochloride (Promethazine HCl)?

See also Warning section.

Before taking promethazine, tell your doctor or pharmacist if you are allergic to it; or to any other phenothiazines (e.g., prochlorperazine); or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

This medication should not be given to a person who is unconscious.

This medication should not be used if you have certain medical conditions. Before using this medicine, consult your doctor or pharmacist if you have: certain lung/breathing problems (e.g., asthma, chronic obstructive pulmonary disease-COPD, sleep apnea).

Before using this medication, tell your doctor or pharmacist your medical history, especially of:...

Read All Potential Precautions of Promethazine HCl


Promethazine HCl Consumer (continued)

SIDE EFFECTS: Drowsiness, dizziness, constipation, blurred vision, or dry mouth may occur. If any of these effects persist or worsen, notify your doctor.

Some people, particularly children, may experience excitability rather than drowsiness.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor immediately if any of these unlikely but serious side effects occur: lack of coordination, severe dizziness, ringing ears, fainting, slow heartbeat, mental/mood changes (e.g., hallucinations, nervousness, irritability), involuntary movements (e.g., fixed upward stare, neck twisting, tongue movements), restlessness, shaking (tremor), decreased/painful urination, weakness, vision changes (e.g., double vision).

Stop taking this medication and seek immediate medical attention if any of these rare but very serious side effects occur: slow/shallow breathing, signs of infection (e.g., fever, persistent sore throat), severe abdominal pain, persistent nausea/vomiting, easy bleeding/bruising, yellowing eyes/skin, dark urine.

This drug may infrequently cause a very serious (rarely fatal) nervous system disorder (neuroleptic malignant syndrome). If you notice any of the following unlikely but very serious side effects, stop taking this medication and seek immediate medical attention: severe muscle stiffness, mental/mood changes (e.g., sudden confusion, extreme drowsiness), very high fever, seizures, irregular/fast heartbeat, increased sweating.

A very serious allergic reaction to this drug is unlikely, but stop taking this medication and seek immediate medical attention if it occurs. Symptoms of a serious allergic reaction include: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

PRECAUTIONS: See also Warning section.

Before taking promethazine, tell your doctor or pharmacist if you are allergic to it; or to any other phenothiazines (e.g., prochlorperazine); or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

This medication should not be given to a person who is unconscious.

This medication should not be used if you have certain medical conditions. Before using this medicine, consult your doctor or pharmacist if you have: certain lung/breathing problems (e.g., asthma, chronic obstructive pulmonary disease-COPD, sleep apnea).

Before using this medication, tell your doctor or pharmacist your medical history, especially of: blood/immune system problems (e.g., bone marrow depression), a certain eye problem (narrow-angle glaucoma), heart disease (e.g., angina, irregular heartbeat), high blood pressure, liver disease, certain nervous system problems (e.g., neuroleptic malignant syndrome, Reye's syndrome), seizure, stomach/bowel problems (e.g., blockage, ulcer disease), sun sensitivity when using other medications, urination problems (e.g., due to enlarged prostate, blockage).

This drug may make you dizzy or drowsy or cause blurred vision. Do not drive, use machinery, or do any activity that requires alertness or clear vision until you are sure you can perform such activities safely. Children should be supervised to avoid injury during bicycle riding or other possibly hazardous activities. Avoid alcoholic beverages.

Promethazine may make you more sensitive to the sun. Avoid prolonged sun exposure, tanning booths, and sunlamps. Use a sunscreen and wear protective clothing when outdoors.

This medication can reduce sweating, making you more likely to get heat stroke. Avoid strenuous work/exercise, drink plenty of fluids, and dress lightly while in hot weather.

Liquid products may contain sugar and alcohol. Caution is advised if you have diabetes, alcohol dependence, liver disease, or any other condition that requires you to limit/avoid these substances in your diet. Ask your doctor or pharmacist about using this product safely.

Caution is advised when using this drug in the elderly because they may be more sensitive to its effects, especially confusion and drowsiness.

Caution is advised when using this drug in children because they may be more sensitive to its effects, especially slowed breathing (see Warning section). Special caution should be taken in children who have lost a lot of fluid (dehydration), those who have a family history of sudden infant death syndrome (SIDS), and those who are hard to wake up from sleep.

This medication should be used only when clearly needed during pregnancy. Discuss the risks and benefits with your doctor.

It is unknown whether promethazine passes into breast milk. It may have undesirable effects on a nursing infant. Therefore, breast-feeding while using this medication is not recommended. Consult your doctor before breast-feeding.



Related Drugs Index: