Phenergan

(Generic versions may still be available.)

DRUG DESCRIPTION

Each tablet of Phenergan contains 12.5 mg, 25 mg, or 50 mg promethazine HCl. The inactive ingredients present are lactose, magnesium stearate, and methylcellulose. Each dosage strength also contains the following:

12.5 mg-FD&C Yellow 6 and saccharin sodium;
25 mg-saccharin sodium;
50 mg-FD&C Red 40.

Each rectal suppository of Phenergan contains 12.5 mg, 25 mg, or 50 mg promethazine HCl with ascorbyl palmitate, silicon dioxide, white wax, and cocoa butter. Phenergan (promethazine) 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,alpha;-trimethyl-, monohydrochloride, (±)- with the following structural formula:

Phenergan (promethazine HCI) structural formula illustration

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 freely soluble in water and soluble in alcohol.

What are the possible side effects of oral promethazine (Pentazine, Phenergan)?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Stop using promethazine and call your doctor at once if you have any of these serious side effects:

  • twitching, or uncontrollable movements of your eyes, lips, tongue, face, arms, or legs;
  • tremor (uncontrolled shaking), drooling, trouble swallowing, problems with balance or walking;
  • feeling restless, jittery, or agitated;
  • ...

Read All Potential Side Effects and See Pictures of Phenergan »

What are the precautions when taking promethazine (Phenergan)?

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 Phenergan »


Phenergan 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.


Phenergan Patient Information Including Side Effects

Brand Names: Pentazine, Phenergan

Generic Name: promethazine (oral) (Pronunciation: pro METH a zeen)

  • What is oral promethazine (Phenergan)?
  • What are the possible side effects of oral promethazine (Phenergan)?
  • What is the most important information I should know about oral promethazine (Phenergan)?
  • What should I discuss with my doctor before taking oral promethazine (Phenergan)?
  • How should I take oral promethazine (Phenergan)?
  • What happens if I miss a dose (Phenergan)?
  • What happens if I overdose (Phenergan)?
  • What should I avoid while taking oral promethazine (Phenergan)?
  • What other drugs will affect oral promethazine (Phenergan)?
  • Where can I get more information?

What is oral promethazine (Phenergan)?

Promethazine is in a group of drugs called phenothiazines (FEEN-oh-THYE-a-zeens). It works by changing the actions of chemicals in your brain. Promethazine also acts as an antihistamine. It blocks the effects of the naturally occurring chemical histamine in your body.

Promethazine is used to treat allergy symptoms such as itching, runny nose, sneezing, itchy or watery eyes, hives, and itchy skin rashes.

Promethazine also prevents motion sickness, and treats nausea and vomiting or pain after surgery. It is also used as a sedative or sleep aid.

Promethazine is not for use in treating symptoms of asthma, pneumonia, or other lower respiratory tract infections.

Promethazine may also be used for other purposes not listed in this medication guide.

What are the possible side effects of oral promethazine (Phenergan)?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Stop using promethazine and call your doctor at once if you have any of these serious side effects:

  • twitching, or uncontrollable movements of your eyes, lips, tongue, face, arms, or legs;
  • tremor (uncontrolled shaking), drooling, trouble swallowing, problems with balance or walking;
  • feeling restless, jittery, or agitated;
  • high fever, stiff muscles, confusion, sweating, fast or uneven heartbeats, rapid breathing;
  • feeling like you might pass out;
  • seizure (convulsions);
  • pale skin, easy bruising or bleeding, fever, sore throat, flu symptoms;
  • decreased night vision, tunnel vision, watery eyes, increased sensitivity to light;
  • hallucinations, agitation;
  • nausea and stomach pain, skin rash, and jaundice (yellowing of the skin or eyes);
  • urinating less than usual or not at all;
  • joint pain or swelling with fever, swollen glands, muscle aches, chest pain, vomiting, unusual thoughts or behavior, and patchy skin color; or
  • slow heart rate, weak pulse, fainting, slow breathing (breathing may stop).

Less serious side effects may include:

  • dizziness, drowsiness, anxiety;
  • blurred vision, dry mouth, stuffy nose;
  • ringing in your ears;
  • weight gain, swelling in your hands or feet;
  • impotence, trouble having an orgasm; or
  • constipation.

This is not a complete list of side effects and others may occur. Tell your doctor about any unusual or bothersome side effect. You may report side effects to FDA at 1-800-FDA-1088.

What is the most important information I should know about oral promethazine (Phenergan)?

Stop using this medication and call your doctor at once if you have twitching or uncontrollable movements of your eyes, lips, tongue, face, arms, or legs. These could be early signs of dangerous side effects.

Promethazine should not be given to a child younger than 2 years old. Promethazine can cause severe breathing problems or death in a child younger than 2. Carefully follow your doctor's instructions when giving this medicine to a child of any age.

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 drinking alcohol, which can increase some of the side effects of promethazine.

There are many other medicines that can interact with promethazine. Tell your doctor about all the prescription and over-the-counter medications you use. This includes vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start using a new medication without telling your doctor. Keep a list with you of all the medicines you use and show this list to any doctor or other healthcare provider who treats you.

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