Friday, March 22, 2024

Hydrocortisone Acetate 2.5 Pramoxine Hcl 1 Cream Hemorrhoids

Warnings For Other Groups

Proctofoam® HC (hydrocortisone acetate 1% and pramoxine hydrochloride 1%) Instructions for Use

For pregnant women: This drug is a category C pregnancy drug. That means two things:

  • Research in animals has shown adverse effects to the fetus when the mother uses the drug.
  • There havent been enough studies done in humans to be certain how the drug might affect the fetus.
  • Talk to your doctor if youre pregnant or planning to become pregnant. This drug should only be used if the potential benefit justifies the potential risk.

    If you become pregnant while using this drug, call your doctor right away.

    For women who are breastfeeding: It is not known whether this drug passes into breast milk. Talk to your doctor if you breastfeed your child.

    For children: Children may be more sensitive to the effects of hydrocortisone. Hydrocortisone may have very minor effects on their growth. Children who are treated with this drug should be prescribed the smallest dose thats effective for their condition.

    All possible dosages and drug forms may not be included here. Your dosage, drug form, and how often you use the drug will depend on:

    • how severe your condition is
    • other medical conditions you have
    • how you react to the first dose

    More Common Side Effects

    The adult side effects for this drug are slightly different from the side effects for children.

    More common side effects in adults include:

    In addition to the side effects listed above, children may experience:

    • slowed weight gain
    • lowered cortisol levels

    If these effects are mild, they may go away within a few days or a couple of weeks. If theyre more severe or dont go away, talk to your doctor or pharmacist.

    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.

    Dosage For Inflammation And Itching

    Generic: Hydrocortisone-pramoxine

    • Strengths: 1% or 2.5% hydrocortisone and 1% pramoxine

    Brand: Pramosone

    • Strengths: 1% or 2.5% hydrocortisone and 1% pramoxine

    Adult dosage

    Apply a thin film of the drug to the affected skin three to four times per day.

    Child dosage

    • There are no specific dosing recommendations for the use of this drug in people younger than 18 years.
    • This drug should be used with caution in people younger than 18 years. They are at increased risk of side effects.

    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 list includes all possible dosages. This information is not a substitute for medical advice. Always speak with your doctor or pharmacist about dosages that are right for you.

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    What Should I Know About Storage And Disposal Of This Medication

    Keep this medication in the container it came in, tightly closed, and out of reach of children. Store it according to the package instructions. Store it at room temperature and away from excess heat and moisture . Do not freeze or refrigerate rectal hydrocortisone products.

    Unneeded medications should be disposed of in special ways to ensure that pets, children, and other people cannot consume them. However, you should not flush this medication down the toilet. Instead, the best way to dispose of your medication is through a medicine take-back program. Talk to your pharmacist or contact your local garbage/recycling department to learn about take-back programs in your community. See the FDA’s Safe Disposal of Medicines website for more information if you do not have access to a take-back program.

    It is important to keep all medication out of sight and reach of children as many containers are not child-resistant and young children can open them easily. To protect young children from poisoning, always lock safety caps and immediately place the medication in a safe location â one that is up and away and out of their sight and reach.

    How Should I Use This Medication

    Nix Dermal Cream (Permethrin)

    This medicine is for external use only. Do not take by mouth. Follow the directions on the prescription label. Wash your hands before and after use. Apply a thin film of medicine to the affected area. Do not cover with a bandage or dressing unless your doctor or health care professional tells you to. Do not use on healthy skin or over large areas of skin. Do not get this medicine in your eyes. If you do, rinse out with plenty of cool tap water. It is important not to use more medicine than prescribed. Do not use your medicine more often than directed. Do not use for more than 14 days.

    Talk to your pediatrician regarding the use of this medicine in children. Special care may be needed. If applying this medicine to the diaper area of a child, do not cover with tight-fitting diapers or plastic pants. This may increase the amount of medicine that passes through the skin and increase the risk of serious side effects.

    Elderly patients are more likely to have damaged skin through aging, and this may increase side effects. This medicine should only be used for brief periods and infrequently in older patients.

    Overdosage: If you think you have taken too much of this medicine contact a poison control center or emergency room at once.

    NOTE: This medicine is only for you. Do not share this medicine with others.

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    How Should I Use Hydrocortisone And Pramoxine Topical

    Follow all directions on your prescription label. Do not use this medicine in larger or smaller amounts or for longer than recommended.

    Do not use hydrocortisone and pramoxine to treat any condition that has not been checked by your doctor.

    Wash your hands before and after applying this medicine, unless you are using hydrocortisone and pramoxine to treat a hand condition.

    Use only a small amount of hydrocortisone and pramoxine topical on the affected area and rub it gently into the skin.

    Do not cover the treated skin area unless your doctor tells you to. Covering the skin that is treated with this medicine can increase the amount of the drug your skin absorbs, which may lead to unwanted side effects. Follow your doctor’s instructions.

    Do not take hydrocortisone and pramoxine rectal by mouth. It is for use only in your rectum.

    Shake the hydrocortisone and pramoxine rectal foam before each use.

    For best results from the rectal medication, use only the applicator provided with the medication. Otherwise, follow the directions provided with your medicine.

    Clean the rectal area with mild soap and water before applying the medicine, or use any cleansing wipes provided with your medicine.

    Your body may absorb too much of this medication if you use a large amount, if you apply it over large skin areas, or if you cover treated skin with heat, bandages, or plastic wrap. Skin that is cut or irritated may also absorb more topical medication than healthy skin.

    How To Use Hydrocortisone

    Before applying the medication, clean the affected area with mild soap and water, rinse well, and pat dry. Gently rub a small amount of the medication into the affected area and surrounding skin in a thin layer, usually 3-4 times a day or as directed by your doctor. How often the medication is applied and for how long depends on your condition and response to treatment.

    Wash hands immediately after use unless the area being treated includes the hands. Avoid getting the product in your eyes, nose, ears, or mouth. If the medication gets in these areas, rinse immediately with clean water.

    Do not cover the area with waterproof bandages or plastic, apply heat, or use the product on large areas of the body unless directed to do so by your doctor. If used in the diaper area on an infant, do not use tight-fitting diapers or plastic pants. These may increase the risk of side effects.

    Use this medication regularly in order to get the most benefit from it. To help you remember, use it at the same times each day.

    Do not use more of this product, use it more often, or keep using it longer than prescribed by your doctor. If you have been using this medication for a long time or in high doses, do not suddenly stop using it without your doctor’s approval. Some conditions may become worse when this drug is suddenly stopped. Your dose may need to be gradually decreased.

    Inform your doctor if your condition does not improve or if it worsens.

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    Before Taking This Medicine

    You should not use hydrocortisone and pramoxine if you are allergic to hydrocortisone or pramoxine, or to any other anesthetics or “numbing medicines.”

    To make sure hydrocortisone and pramoxine is safe for you, tell your doctor if you have:

    • a stomach or intestinal disorder

    • a rectal sore or infection or

    • if you use any drugs that weaken the immune system, including steroids.

    Hydrocortisone and pramoxine topical will not treat a bacterial, fungal, or viral skin infection. If you have a skin infection, you should not use this medication until your infection is treated and clears up.

    FDA pregnancy category C. It is not known whether hydrocortisone and pramoxine will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant while using this medication.

    It is not known whether hydrocortisone and pramoxine passes into breast milk or if it could harm a nursing baby. Tell your doctor if you are breast-feeding a baby.

    Do not use this medicine on a child without a doctor’s advice. Children are more sensitive to the effects of topical hydrocortisone.

    What Other Drugs Will Affect Hydrocortisone And Pramoxine Topical

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    It is not likely that other drugs you take orally or inject will have an effect on topically applied hydrocortisone and pramoxine. But many drugs can interact with each other. Tell each of your health care providers about all medicines you use, including prescription and over-the-counter medicines, vitamins, and herbal products.

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    Standard Product Labeling /prescribing Informationspl 982f0862

    SPL UNCLASSIFIED SECTION

    Rx Only

    DESCRIPTION

    Hydrocortisone Acetate 2.5% and Pramoxine HCl 1% Cream is a topical preparation containing hydrocortisone acetate 2.5% w/w and pramoxine hydrochloride 1% w/w in a hydrophilic cream base containing stearic acid, cetyl alcohol, Aquaphor ®, isopropyl palmitate, polyoxyl 40 stearate, propylene glycol, potassium sorbate, sorbic acid, triethanolamine lauryl sulfate, and purified water.

    Topical corticosteroids are anti-inflammatory and anti-pruritic agents. The structural formula, the chemical name, molecular formula and molecular weight for the active ingredients are presented below.

    CLINICAL PHARMACOLOGY

    Topical corticosteroids share anti-inflammatory, anti-pruritic and vasoconstrictive actions.

    The mechanism of anti-inflammatory activity of topical corticosteroids is unclear. Various laboratory methods, including vasoconstrictor assays, are used to compare and predict potencies and/or clinical efficacies of the topical corticosteroids. There is some evidence to suggest that a recognizable correlation exists between vasoconstrictor potency and therapeutic efficacy in man.

    Pramoxine hydrochloride is a topical anesthetic agent which provides temporary relief from itching and pain. It acts by stabilizing the neuronal membrane of nerve endings with which it comes into contact.

    Pharmacokinetics

    INDICATIONS AND USAGE

    CONTRAINDICATIONS

    PRECAUTIONS

    General –
    Information for The Patient –
    Laboratory Tests –
    Teratogenic Effects:

    Burning

    Who Is More Prone To Hemorrhoids

    Hemorrhoids are especially common in pregnancy and the postpartum period. This is partly due to the changes that occur during pregnancy. It is also caused by the strain of pushing during labor, which can cause new hemorrhoids and also worsen existing ones. Overweight individuals and those with a family history of hemorrhoids are more likely to develop them. The risk increases with aging, with at least half of people who are 50 years or older seeking some form of care for them.

    Recommended Reading: What To Do For Very Painful Hemorrhoids

    What Is This Medication

    HYDROCORTISONE PRAMOXINE is a combination of a corticosteroid and an anesthetic.It is used to decrease swelling, itching and pain that is caused by minor skin irritations or hemorrhoids.

    This medicine may be used for other purposes ask your health care provider or pharmacist if you have questions.

    COMMON BRAND NAME: Analpram E, Analpram HC, EndaRoid, Enzone, HC Pram, Mezparox-HC, Mezparox-HC Forte, Novacort, Paramox-HC, PRAM-HCA, PramCort, Pramosone, Pramosone E, ProCort, Proctocream-HC, Z-Pram, Zone A, Zone A Forte, ZyPram

    How Is Hydrocortisone And Pramoxine Cream Supplied

    Hydrocortisone Acetate 2.5% and Pramoxine HCl 1% Cream is available as follows:

    1 oz tube

    Store at 25ºC excursions permitted to 15-30ºC .

    KEEP OUT OF REACH OF CHILDREN

    TAMPER EVIDENT: Do not use if foil seal is missing or damaged.

    For lot number and exp date, see crimp of tube or carton.

    All prescription substitutions and/or recomendations using this product shall be made subject to state and federal statutes as applicable. Please NOTE: This is not an Orange Book product and has not been subjected to FDA therapeutic or other equilency testing. No representation is made as to generic status or bioequivalency. Each person recommending a prescription substitution using this product shall make such recommendation based on his/her professional knowledge and opinion, upon evaluating the active ingredients, inactive ingredients, excipients and chemical information provided herein.

    Manufactured for:

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    Rectal Hydrocortisone May Cause Side Effects Tell Your Doctor If Any Of These Symptoms Are Severe Or Do Not Go Away:

    • extreme changes in mood changes in personality
    • inappropriate happiness
    • difficulty falling asleep or staying asleep
    • slowed healing of cuts and bruises
    • irregular or absent menstrual periods
    • thin, fragile, or dry skin
    • swelling of the eyes, face, lips, tongue, throat, hands, arms, feet, ankles, or lower legs
    • difficulty breathing or swallowing

    Children who use rectal hydrocortisone may have an increased risk of side effects including slowed growth and delayed weight gain. Talk to your child’s doctor about the risks of using this medication.

    People who use rectal hydrocortisone for a long time may develop glaucoma or cataracts. Talk to your doctor about the risks of using rectal hydrocortisone and how often you should have your eyes examined during your treatment.

    Rectal hydrocortisone may increase your risk of developing osteoporosis. Talk to your doctor about the risks of using this medication.

    Rectal hydrocortisone may cause other side effects. Call your doctor if you have any unusual problems while using this medication.

    If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration’s MedWatch Adverse Event Reporting program online or by phone .

    Information For The Patient

    Patients using topical corticosteroids should receive the following information and instructions:

  • This medication is to be used as directed by the physician. It is for external use only. Avoid contact with the eyes.
  • Patients should be advised not to use this medication for any disorder other than for which it was prescribed.
  • The treated skin area should not be bandaged or otherwise covered or wrapped as to be occlusive unless directed by the physician.
  • Patients should report any signed of local adverse reactions especially under occlusive dressings.
  • Parents of pediatric patients should be advised to use tight-fitting diapers or plastic pants on a child being treated in the diaper area, as these garments may constitute occlusive dressings.
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    Hydrocortisone And Pramoxine Cream

    Topical corticosteroids share anti-inflammatory, anti-pruritic and vasoconstrictive actions.

    The mechanism of anti-inflammatory activity of topical corticosteroids is unclear. Various laboratory methods, including vasoconstrictor assays, are used to compare and predict potencies and/or clinical efficacies of the topical corticosteroids. There is some evidence to suggest that a recognizable correlation exists between vasoconstrictor potency and therapeutic efficacy in man.

    Pramoxine hydrochloride is a topical anesthetic agent which provides temporary relief from itching and pain. It acts by stabilizing the neuronal membrane of nerve endings with which it comes into contact.

    When To See A Physician

    How and When to use Hydrocortisone (Acecort, Ala-cor, Plenadren) – Doctor Explains

    It is also important to note that rectal bleeding requires an immediate physician appointment. Never assume that rectal bleeding is a minor problem that will disappear on its own. Rather, view it as a cause for alarm that requires an immediate physician appointment to screen you for such problems as colorectal cancer.

    Hemorrhoids occur with greater frequency as a person ages. Thus, hemorrhoid products should never be used on anyone under the age of 12 years. If you experience protrusion , you should also see a physician. These are prolapsed internal hemorrhoids that should be checked to see if they require surgical correction.

    Read Also: How To Check For Hemorrhoids

    How Should This Medicine Be Used

    Hydrocortisone rectal comes as a cream, an enema, suppositories, and a foam to use in the rectum. Follow the directions on your prescription or your product label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Use rectal hydrocortisone exactly as directed. Do not use it more or less of it or use it more often than prescribed by your doctor.

    For proctitis, hydrocortisone rectal foam usually is used one or two times a day for 2 to 3 weeks, then if necessary, every other day until your condition improves. Hydrocortisone rectal suppositories usually are used two or three times daily for 2 weeks may require treatment for up to 6 to 8 weeks in severe cases. Proctitis symptoms may improve within 5 to 7 days.

    For hemorrhoids, hydrocortisone rectal cream usually is used in adults and children 12 years and older up to 3 or 4 times daily. If you obtained hydrocortisone without a prescription and your condition does not improve within 7 days, stop using it and call your doctor. Do not put the cream into your rectum with your fingers.

    For ulcerative colitis, hydrocortisone rectal enema usually is used every night for 21 days. Although colitis symptoms may improve within 3 to 5 days, 2 to 3 months of regular enema use may be required. Call your doctor if your colitis symptoms do not improve within 2 or 3 weeks.

    If using a hydrocortisone rectal enema, follow these steps:

  • Shake the enema bottle well to make sure the medication is mixed.
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