Promadryl tablets

Promadryl

  • Active Ingredient: Promethazine
  • 25 mg
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What is Promadryl?

The active ingredient of Promadryl brand is promethazine. 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 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 freely soluble in water and soluble in alcohol.

Used for

Promadryl is used to treat diseases such as: Allergic Reactions, Allergic Rhinitis, Anaphylaxis, Light Sedation, Motion Sickness, Nausea/Vomiting, Opiate Adjunct, Sedation, Urticaria, Vertigo.

Side Effect

Possible side effects of Promadryl include: difficult or unusually fast breathing; yellow eyes or skin; vomiting; unable to sleep; seeing, hearing, or feeling things that are not there; holding false beliefs that cannot be changed by fact.

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Serious side effects

Call your doctor right away if you have serious side effects. Call 911 if your symptoms feel life-threatening or if you think you’re having a medical emergency. Serious side effects and their symptoms can include the following:

  • Extrapyramidal symptoms (uncontrollable movements). Symptoms can include:
    • uncontrollable upward staring, and eye and lid twitching
    • uncontrollable neck muscle contractions causing your head to twist or turn to one side
    • sticking your tongue out uncontrollably
  • Seizures
  • Hallucinations (seeing or hearing things that aren’t there)
  • palpitations
  • dizziness
  • fainting
  • shortness of breath
  • chest pain
  • light headedness
  • bruising or abnormal bleeding. This includes bleeding from minor cuts, nose or mouth bleeding, and pinpoint red spots on your skin. It also includes abnormally heavy menstrual flow, blood in your urine, or black tarry stools.
  • fevers or infections
  • Severe breathing problems
  • swelling usually around your eyes and lips and sometimes your throat, hands, and feet
  • swelling on the surface of your skin (welts)
  • painful and itchy welts (hives)
  • fever
  • muscle rigidity
  • mental changes
  • changes in pulse or blood pressure
  • fast heart rate
  • increased sweating
  • irregular heart rhythm
  • yellow skin
  • yellowing of the whites of your eyes
  • dark or brown-colored urine
  • yellowing of the inside of your mouth
  • pale or clay-colored stools
  • Disclaimer: Our goal is to provide you with the most relevant and current information. However, because drugs affect each person differently, we cannot guarantee that this information includes all possible side effects. This information is not a substitute for medical advice. Always discuss possible side effects with a healthcare provider who knows your medical history.

    Promadryl oral tablet can interact with other medications, vitamins, or herbs you may be taking. An interaction is when a substance changes the way a drug works. This can be harmful or prevent the drug from working well.

    To help avoid interactions, your doctor should manage all of your medications carefully. Be sure to tell your doctor about all medications, vitamins, or herbs you’re taking. To find out how this drug might interact with something else you’re taking, talk to your doctor or pharmacist.

    Examples of drugs that can cause interactions with Promadryl are listed below.

    Allergy

    The average oral dose is 25 mg taken before retiring; however, 12.5 mg may be taken before meals and on retiring, if necessary. Single 25-mg doses at bedtime or 6.25 to 12.5 mg taken three times daily will usually suffice. After initiation of treatment in children or adults, dosage should be adjusted to the smallest amount adequate. The administration of Promadryl HCl (Promadryl hydrochloride) in 25-mg doses will control minor transfusion reactions of an allergic nature.

    Some side effects can be serious. If you experience any of the following symptoms, call your doctor immediately:

    • wheezing
    • slowed breathing
    • breathing stops for a short time
    • fever
    • sweating
    • stiff muscles
    • decreased alertness
    • fast or irregular pulse or heartbeat
    • faintness
    • abnormal or uncontrollable movements
    • hallucinations (seeing things or hearing voices that do not exist)
    • confusion
    • overwhelming or unmanageable fear or emotion
    • seizures
    • uncontrollable shaking of a part of the body
    • unusual bruising or bleeding
    • sore throat, fever, chills, and other signs of infection
    • uncontrolled eye movements
    • tongue sticking out
    • abnormal neck position
    • inability to respond to people around you
    • yellowing of the skin or eyes
    • rash
    • hives
    • swelling of the face, eyes, lips, tongue, throat, arms, hands, feet, ankles, or lower legs
    • hoarseness
    • difficulty breathing or swallowing

    If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration's (FDA) MedWatch Adverse Event Reporting program online (http://www.fda.gov/Safety/MedWatch) or by phone (1-800-332-1088).

    Promadryl may cause other side effects. Call your doctor if you experience any unusual problems while you are taking this medication.

    Nausea and motion sickness drugs

    When you take certain nausea and motion sickness drugs with Promadryl, certain side effects may increase and last longer. These side effects include dry mouth, constipation, trouble emptying your bladder, blurred vision, and drowsiness. Examples of these drugs include:

    What is Promadryl, and how does it work (mechanism of action)?

    Promadryl is a phenothiazine in the same drug class as chlorpromazine (Thorazine) and trifluoperazine (Stelazine). However, unlike the other drugs in this class, Promadryl is not used as an anti-psychotic. It used as an anti-histamine, sedative, and antiemetic (anti-nausea). The body releases histamine during several types of allergic reactions. When histamine binds to its receptors on cells, it stimulates changes within the cells that lead to sneezing, itching, and increased mucus production. Antihistamines such as Promadryl compete with histamine for one of the receptors for histamine (the H1 receptor) on cells. However, when the antihistamines bind to the receptors they do not stimulate the cells. Instead, they prevent histamine from binding and stimulating the cells. Promadryl also blocks the action of acetylcholine (anticholinergic effect), and this may explain its benefit in reducing the nausea of motion sickness. It is used as a sedative because it causes drowsiness as a side effect. The FDA approved Promadryl in 1951.

    How to take Promadryl

    • Before you start this treatment, read the manufacturer's printed information leaflet from ins >

    How should I take Promadryl?

    Take Promadryl exactly as prescribed by your doctor. Follow all directions on your prescription label. Your doctor may occasionally change your dose to make sure you get the best results. Do not take this medicine in larger or smaller amounts or for longer than recommended.

    Promadryl is often taken at bedtime or before meals. For motion sickness, Promadryl is usually started within 1 hour before traveling. When used for surgery, Promadryl is usually taken the night before the surgery.

    How often you take this medicine and the timing of your dose will depend on the condition being treated.

    Measure liquid medicine with the dosing syringe provided, or with a special dose-measuring spoon or medicine cup. If you do not have a dose-measuring device, ask your pharmacist for one.

    If a child is using this medicine, tell your doctor if the child has any changes in weight. Promadryl doses are based on weight in children, and any changes may affect your child's dose.

    Call your doctor if your symptoms do not improve, or if they get worse while using Promadryl.

    This medicine can cause unusual results with certain medical tests. Tell any doctor who treats you that you are using Promadryl.

    Store at room temperature away from moisture, heat, and light.

    How Does Promadryl Work?

    Promadryl is used as a histamine-receptor blocker. Histamine receptors are proteins that bind with histamine to produce allergic reactions. This makes Promadryl an effective antihistamine. The drug also blocks acetylcholine receptors, making it useful to prevent and treat nausea, morning sickness and cough. Promadryl can only help control symptoms. It isn’t effective in treating the cause of symptoms or in speeding recovery, according to the National Institutes of Health (NIH).

    IMPORTANT WARNING:

    Promadryl may cause breathing to slow or stop, and may cause death in children. Promadryl should not be given to babies or children who are younger than 2 years old and should be given with caution to children who are 2 years of age or older. Combination products containing Promadryl and codeine should not be given to children younger than 16 years old. Promadryl should not routinely be used to treat vomiting in children; it should only be used in specific cases when a doctor decides that it is needed. Tell your child's doctor if your child has any condition that affects his/her breathing such as lung disease, asthma, or sleep apnea (stops breathing for short periods of time during sleep). Tell your doctor or pharmacist about all the medications your child is taking, especially barbiturates such as phenobarbital (Luminal), medications for anxiety, narcotic medications for pain, sedatives, sleeping pills, and tranquilizers. Call your child's doctor immediately and get emergency medical treatment if your child has difficulty breathing, wheezes, slows or pauses in breathing, or stops breathing.

    Talk to your doctor about the risks of giving Promadryl to your child.

    Common Side Effects of Promadryl

    • Dizziness
    • Drowsiness
    • Dry mouth
    • Blurred vision
    • Stuffy nose
    • Ringing in the ears
    • Constipation
    • Weight gain
    • Impotence or trouble having an orgasm

    What Is Promadryl and How Does It Work?

    Promadryl is used to prevent and treat nausea and vomiting related to certain conditions (such as motion sickness, or before/after surgery). It is also used to treat allergy symptoms such as rash, itching, and runny nose. It may be used to help you feel sleepy/relaxed before and after surgery or to help certain narcotic pain relievers (such as meperidine) work better. The suppository form is used when medications cannot be taken by mouth.

    Promadryl is an antihistamine and works by blocking a certain natural substance (histamine) that your body makes during an allergic reaction. Its other effects (such as anti-nausea, calming, pain relief) may work by affecting other natural substances (such as acetylcholine) and by acting directly on certain parts of the brain.

    Promadryl is available under the following different brand names: Phenergan, and Phenadoz.

    Dosage of Promadryl:

    Adult Dosage Forms and Strengths

    Dosing Consideraations – Should be Given as Follows:

    • Taken orally or rectally: 25 mg at bedtime or 12.5 mg before meals and at bedtime (dosage range, 6.25-12.5 mg once every 8 hours)
    • Intravenously (IV)/intramuscularly (IM): 25 mg; may be repeated in 2 hours when necessary; switch to oral dosing as soon as possible

    Nausea and Vomiting

    • Taken orally or rectally: 12.5-25 mg once every 4-6 hours as needed
    • Intravenously (IV)/intramuscularly (IM): 12.5-25 mg once every 4-6 hours as needed

    • 25 mg taken orally or rectally 30-60 minutes before departure and once every 8-12 hours as needed; on succeeding travel days, 25 mg orally or rectally every morning and every evening

    • 50 mg taken orally or rectally on night before procedure or 25-50 mg intravenously (IV)/intramuscularly (IM) combined with reduced doses of analgesics and atropine-like drugs

    • 25-50 mg intravenously/intramuscularly/orally/rectally combined with reduced doses of analgesics and atropine-like drugs

    • 25-50 mg intravenously (IV)/intramuscularly (IM) in early labor; may be increased to 25-75 mg once every 2-4 hours after labor established; not to exceed two doses or up to 100 mg/day during labor

    Allergic Conditions (Off-label)

    • Children under 2 years old: Contraindicated
    • Children 2 years and older: 25 mg taken orally or rectally at bedtime or 12.5 mg once every 6 hours; alternatively, 6.25-12.5 mg orally/rectally once every 8 hours

    • Children under 2 years old: Contraindicated
    • Children 2 years and older: 0.25-1 mg/kg orally/rectally once every 4-6 hours as needed; not to exceed 25 mg

    • Children under 2 years: Contraindicated
    • Children 2 years and older: 12.5-25 mg orally/rectally administered 30-60 minutes before departure and once every 8-12 hours as needed or 0.5 mg/kg orally once every 12 hours as needed
    • Succeeding days of travel: 12.5-25 mg twice daily (upon arising or before evening meals)

    • Children under 2 years: Contraindicated
    • Children 2 years and older: 12.5-25 mg orally/intramuscularly/rectally at bedtime

    • Children under 2 years: Contraindicated
    • Children 2 years and older: 1 mg/kg orally or rectally with reduced dose of analgesic and appropriate dose of atropine-like drug

    • Children under 2 years: Contraindicated
    • Children 2 years and older: 12.5-25 mg with reduced dose of analgesic and appropriate dose of atropine-like drug

    Michael Stewart, Reviewed by Prof Cathy Jackson | Last edited 21 Mar 2017 | Certified by The Information Standard

    Promadryl is an antihistamine.

    You may need to take one or more doses during a day, depending upon the reason you are taking it. Make sure you carefully follow the directions on the label.

    Promadryl may affect your ability to drive and to use tools or machines.

    The most common side-effects are feeling sleepy, headache, dry mouth and blurred vision.

    The usual dose of Promadryl required for moderate sedation after IV administration is approximately 25 to 35 mg. This drug should be administered in a concentration of 25 mg/mL. 71

    What other drugs will affect Promadryl?

    Cold or allergy medicine, sedatives, narcotic pain medicine, sleeping pills, muscle relaxers, and medicine for seizures, depression or anxiety can interact with Promadryl and cause medical problems or increase side effects. Tell your doctor if you regularly use any of these medicines.

    Also tell your doctor if you are using any of the following medicines:

    lithium (Eskalith, Lithobid);

    atropine (Atreza, Sal-Tropine), belladonna (Donnatal, and others), benztropine (Cogentin), dimenhydrinate (Dramamine), methscopolamine (Pamine), or scopolamine (Transderm-Scop);

    blood pressure medication such as guanadrel (Hylorel), guanethidine (Ismelin), propranolol (Inderal), and others;

    a blood thinner such as warfarin (Coumadin);

    bronchodilators such as ipratropium (Atrovent) or tiotropium (Spiriva);

    bladder or urinary medications such as oxybutynin (Ditropan, Oxytrol), solifenacin (Vesicare), and others;

    an MAO inhibitor such as isocarboxazid (Marplan), tranylcypromine (Parnate), phenelzine (Nardil), or selegiline (Eldepryl, Emsam); or

    medicines to treat Parkinson's disease, restless leg syndrome, or pituitary gland tumor (prolactinoma); or

    medicine to treat stomach ulcer or irritable bowel syndrome, such as dicyclomine (Bentyl), glycopyrrolate (Robinul), hyoscyamine (Anaspaz, Cystospaz, Levsin, and others), mepenzolate (Cantil), or propantheline (Pro-Banthine).

    This list is not complete and there are many other medicines that can interact with Promadryl. Tell your doctor about all your prescription and over-the-counter medications, vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start 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.

    Histamine Blockers (Antihistaminics)

    Promadryl , classified as a histamine blocker, is, on rare occasion, employed for IV moderate sedation. The basic pharmacology of histamine blockers has been discussed in Chapters 7 and 10 . In this section, only those aspects of Promadryl's pharmacology relevant to IV administration are reviewed.

    Why it’s used

    Promadryl is used to treat several conditions, including allergies, motion sickness, nausea and vomiting, anxiety before surgery, and pain after surgery. It’s also used as a sleep aid, including before and after surgery.

    This drug may be used as part of a combination therapy. That means you may need to take it with other medications.


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