Promethazine Suppositories

For all patients taking this medicine (promethazine suppositories):

• If you have an allergy to promethazine or any other part of this medicine.
• If you are allergic to any drugs like this one, any other drugs, foods, or other substances. Tell your doctor about the allergy and what signs you had, like rash; hives; itching; shortness of breath; wheezing; cough; swelling of face, lips, tongue, or throat; or any other signs.
• If you have any of these health problems: Asthma or other breathing problems like COPD (chronic obstructive pulmonary disease) or sleep apnea (breathing problems during sleep).
• If you have any of these health problems: Low blood cell count or poor bone marrow function.
• If you are taking any drugs that can stop your bone marrow from making some of the cells that your body needs. There are many drugs that can do this. Ask your doctor or pharmacist if you are not sure.

Children:

• If your child is throwing up for an unknown reason. Do not give this medicine (promethazine suppositories) to a child who is throwing up for an unknown reason.

This is not a list of all drugs or health problems that interact with this medicine.

Tell your doctor and pharmacist about all of your drugs (prescription or OTC, natural products, vitamins) and health problems. You must check to make sure that it is safe for you to take this medicine (promethazine suppositories) with all of your drugs and health problems. Do not start, stop, or change the dose of any drug without checking with your doctor.

• Tell all of your health care providers that you take this medicine. This includes your doctors, nurses, pharmacists, and dentists.
• Avoid driving and doing other tasks or actions that call for you to be alert or have clear eyesight until you see how this medicine (promethazine suppositories) affects you.
• This medicine may cause the results of some pregnancy tests to be wrong. Talk with the doctor.
• If you have high blood sugar (diabetes), you will need to watch your blood sugar closely.
• Talk with your doctor before you drink alcohol or use other drugs and natural products that slow your actions.
• You may get sunburned more easily. Avoid sun, sunlamps, and tanning beds. Use sunscreen and wear clothing and eyewear that protects you from the sun.
• Talk with your doctor if you have seizures or have ever had seizures.
• If you are 65 or older, use this medicine with care. You could have more side effects.
• Tell your doctor if you are pregnant or plan on getting pregnant. You will need to talk about the benefits and risks of using this medicine (promethazine suppositories) while you are pregnant.
• Tell your doctor if you are breast-feeding. You will need to talk about any risks to your baby.

Use this medicine as ordered by your doctor. Read all information given to you. Follow all instructions closely.

• Use suppository rectally.
• Wash your hands before and after use.
• If suppository is soft, chill in a refrigerator or run cold water over it.
• Take off foil wrapper.
• Put suppository into the rectum with gentle pressure, pointed end first. Do not handle too much.

What do I do if I miss a dose?

• If you take this medicine (promethazine suppositories) on a regular basis, take a missed dose as soon as you think about it.
• If it is close to the time for your next dose, skip the missed dose and go back to your normal time.
• Do not take 2 doses at the same time or extra doses.
• Many times this medicine is taken on an as needed basis. Do not take more often than told by the doctor.

• If your symptoms or health problems do not get better or if they become worse, call your doctor.
• Do not share your drugs with others and do not take anyone else's drugs.
• Keep a list of all your drugs (prescription, natural products, vitamins, OTC) with you. Give this list to your doctor.
• Talk with the doctor before starting any new drug, including prescription or OTC, natural products, or vitamins.
• Some drugs may have another patient information leaflet. Check with your pharmacist. If you have any questions about this medicine (promethazine suppositories), please talk with your doctor, nurse, pharmacist, or other health care provider.
• If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

This information should not be used to decide whether or not to take this medicine or any other medicine. Only the healthcare provider has the knowledge and training to decide which medicines are right for a specific patient. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about this medicine (promethazine suppositories). It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to this medicine. This information is not specific medical advice and does not replace information you receive from the healthcare provider. You must talk with the healthcare provider for complete information about the risks and benefits of using this medicine (promethazine suppositories).

Review Date: October 4, 2017

Each rectal suppository contains 12.5 mg or 25 mg promethazine HCl with ascorbyl palmitate, cocoa butter, colloidal silicon dioxide, and white wax. Promethazine Hydrochloride Suppositories are for rectal administration only.

Promethazine HCl is a racemic compound; the empirical formula is C17H20N2S•HCl and its molecular weight is 320.88. Promethazine HCl, a phenothiazine derivative, is designated chemically as 10H-Phenothiazine, 10-ethanamine, N,N,α-trimethyl-,monohydrochloride, (±)- with the following structural formula:

Promethazine HCl 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.

Signs and symptoms of overdosage with promethazine HCl range from mild depression of the central nervous system and cardiovascular system to profound hypotension, respiratory depression, unconsciousness, and sudden death. Other reported reactions include hyperreflexia, hypertonia, ataxia, athetosis, and extensor-plantar reflexes (Babinski reflex).

Stimulation may be evident, especially in children and geriatric patients. Convulsions may rarely occur. A paradoxical-type reaction has been reported in children receiving single doses of 75 mg to 125 mg orally, characterized by hyperexcitability and nightmares.

Atropine-like signs and symptoms-dry mouth, fixed, dilated pupils, flushing, as well as gastrointestinal symptoms, may occur.

Treatment -

Treatment of overdosage is essentially symptomatic and supportive. Only in cases of extreme overdosage or individual sensitivity do vital signs, including respiration, pulse, blood pressure, temperature, and EKG, need to be monitored. Activated charcoal orally or by lavage may be given, or sodium or magnesium sulfate orally as a cathartic. Attention should be given to the reestablishment of adequate respiratory exchange through provision of a patent airway and institution of assisted or controlled ventilation. Diazepam may be used to control convulsions. Acidosis and electrolyte losses should be corrected. Note that any depressant effects of promethazine HCl are not reversed by naloxone. Avoid analeptics which may cause convulsions.

The treatment of choice for resulting hypotension is administration of intravenous fluids, accompanied by repositioning if indicated. In the event that vasopressors are considered for the management of severe hypotension which does not respond to intravenous fluids and repositioning, the administration of norepinephrine or phenylephrine should be considered. EPINEPHRINE SHOULD NOT BE USED, since its use in patients with partial adrenergic blockade may further lower the blood pressure. Extrapyramidal reactions may be treated with anticholinergic antiparkinsonian agents, diphenhydramine, or barbiturates. Oxygen may also be administered.

Limited experience with dialysis indicates that it is not helpful.

Promethazine HCl Rectal Suppositories USP, are available as follows:

Promethazine HCl Suppositories USP, 12.5 mg carton of 12 suppositories (NDC 45802-758-30)

Promethazine HCl Suppositories USP, 25 mg carton of 12 suppositories (NDC 45802-759-30)

Rx Only

Promethazine Hydrochloride Suppositories USP, 12.5 mg

12 RECTAL SUPPOSITORIES