Thursday, September 29, 2016

Pepto Bismol Oral, Rectal


Generic Name: salicylate (Oral route, Rectal route)


Commonly used brand name(s)

In the U.S.


  • Amigesic

  • Asacol

  • Azulfidine

  • Azulfidine Entabs

  • Bayer

  • Canasa

  • Colazal

  • Dipentum

  • Doan's Extra Strength

  • Doan's Regular

  • Dolobid

  • Ecotrin

  • Kaopectate

  • Pepto Bismol

  • Salflex

  • Tricosal

  • Trilisate

In Canada


  • Alti-Sulfasalazine

  • Arthropan

  • Asacol 800

  • Bismuth Extra Strength

  • Bismuth Original Formula

  • Mesasal

  • Pentasa

  • Pepto-Bismol

  • Pms-Asa Suppository Adult

  • Pms-Asa Suppository Children

  • Salazopyrin

  • Salofalk

Available Dosage Forms:


  • Tablet, Enteric Coated

  • Tablet, Extended Release

  • Suppository

  • Tablet

  • Capsule

  • Tablet, Chewable

  • Tablet, Effervescent

  • Capsule, Delayed Release

  • Gum

  • Tablet, Delayed Release

  • Enema

  • Capsule, Extended Release

  • Liquid

  • Solution

  • Suspension

Uses For Pepto-Bismol


Aspirin may also be used to lessen the chance of heart attack, stroke, or other problems that may occur when a blood vessel is blocked by blood clots. Aspirin helps prevent dangerous blood clots from forming. However, this effect of aspirin may increase the chance of serious bleeding in some people. Therefore, aspirin should be used for this purpose only when your doctor decides, after studying your medical condition and history, that the danger of blood clots is greater than the risk of bleeding. Do not take aspirin to prevent blood clots or a heart attack unless it has been ordered by your doctor.


Salicylates may also be used for other conditions as determined by your doctor.


The caffeine present in some of these products may provide additional relief of headache pain or faster pain relief.


Some salicylates are available only with your medical doctor's or dentist's prescription. Others are available without a prescription; however, your medical doctor or dentist may have special instructions on the proper dose of these medicines for your medical condition.


Importance of Diet


Make certain your health care professional knows if you are on a low-sodium diet. Regular use of large amounts of sodium salicylate (as for arthritis) can add a large amount of sodium to your diet. Sodium salicylate contains 46 mg of sodium in each 325-mg tablet and 92 mg of sodium in each 650-mg tablet.


Before Using Pepto-Bismol


Allergies


Tell your doctor if you have ever had any unusual or allergic reaction to medicines in this group or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.


Pediatric


Do not give aspirin or other salicylates to a child or a teenager with a fever or other symptoms of a virus infection, especially flu or chickenpox, without first discussing its use with your child's doctor. This is very important because salicylates may cause a serious illness called Reye's syndrome in children and teenagers with fever caused by a virus infection, especially flu or chickenpox.


Some children may need to take aspirin or another salicylate regularly (as for arthritis). However, your child's doctor may want to stop the medicine for a while if a fever or other symptoms of a virus infection occur. Discuss this with your child's doctor, so that you will know ahead of time what to do if your child gets sick.


Children who do not have a virus infection may also be more sensitive to the effects of salicylates, especially if they have a fever or have lost large amounts of body fluid because of vomiting, diarrhea, or sweating. This may increase the chance of side effects during treatment.


Geriatric


Elderly people are especially sensitive to the effects of salicylates. This may increase the chance of side effects during treatment.


Pregnancy


Salicylates have not been shown to cause birth defects in humans. Studies on birth defects in humans have been done with aspirin but not with other salicylates. However, salicylates caused birth defects in animal studies.


Some reports have suggested that too much use of aspirin late in pregnancy may cause a decrease in the newborn's weight and possible death of the fetus or newborn infant. However, the mothers in these reports had been taking much larger amounts of aspirin than are usually recommended. Studies of mothers taking aspirin in the doses that are usually recommended did not show these unwanted effects. However, there is a chance that regular use of salicylates late in pregnancy may cause unwanted effects on the heart or blood flow in the fetus or in the newborn infant.


Use of salicylates, especially aspirin, during the last 2 weeks of pregnancy may cause bleeding problems in the fetus before or during delivery or in the newborn infant. Also, too much use of salicylates during the last 3 months of pregnancy may increase the length of pregnancy, prolong labor, cause other problems during delivery, or cause severe bleeding in the mother before, during, or after delivery. Do not take aspirin during the last 3 months of pregnancy unless it has been ordered by your doctor.


Studies in humans have not shown that caffeine (present in some aspirin products) causes birth defects. However, studies in animals have shown that caffeine causes birth defects when given in very large doses (amounts equal to those present in 12 to 24 cups of coffee a day).


Breast Feeding


Salicylates pass into the breast milk. Although salicylates have not been reported to cause problems in nursing babies, it is possible that problems may occur if large amounts are taken regularly, as for arthritis (rheumatism).


Caffeine passes into the breast milk in small amounts.


Interactions with Medicines


Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking any of these medicines, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.


Using medicines in this class with any of the following medicines is not recommended. Your doctor may decide not to treat you with a medication in this class or change some of the other medicines you take.


  • Influenza Virus Vaccine, Live

  • Ketorolac

  • Pentoxifylline

Using medicines in this class with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.


  • Abciximab

  • Acenocoumarol

  • Alteplase, Recombinant

  • Anisindione

  • Ardeparin

  • Argatroban

  • Beta Glucan

  • Bivalirudin

  • Certoparin

  • Cilostazol

  • Citalopram

  • Clopidogrel

  • Clovoxamine

  • Dabigatran Etexilate

  • Dalteparin

  • Danaparoid

  • Desirudin

  • Desvenlafaxine

  • Dicumarol

  • Dipyridamole

  • Duloxetine

  • Enoxaparin

  • Eptifibatide

  • Escitalopram

  • Femoxetine

  • Flesinoxan

  • Fluoxetine

  • Fluvoxamine

  • Fondaparinux

  • Ginkgo

  • Heparin

  • Ketoprofen

  • Lepirudin

  • Methotrexate

  • Milnacipran

  • Nadroparin

  • Naproxen

  • Nefazodone

  • Parnaparin

  • Paroxetine

  • Pemetrexed

  • Phenindione

  • Phenprocoumon

  • Protein C

  • Reteplase, Recombinant

  • Reviparin

  • Riluzole

  • Rivaroxaban

  • Sertraline

  • Sibutramine

  • Tacrolimus

  • Ticlopidine

  • Tinzaparin

  • Tirofiban

  • Varicella Virus Vaccine

  • Venlafaxine

  • Vilazodone

  • Warfarin

  • Zimeldine

Interactions with Food/Tobacco/Alcohol


Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.


Other Medical Problems


The presence of other medical problems may affect the use of medicines in this class. Make sure you tell your doctor if you have any other medical problems, especially:


  • Anemia or

  • Overactive thyroid or

  • Stomach ulcer or other stomach problems—Salicylates may make your condition worse.

  • Asthma, allergies, and nasal polyps (history of) or

  • Glucose-6-phosphate dehydrogenase (G6PD) deficiency or

  • High blood pressure (hypertension) or

  • Kidney disease or

  • Liver disease—The chance of side effects may be increased.

  • Gout—Salicylates can make this condition worse and can also lessen the effects of some medicines used to treat gout.

  • Heart disease—The chance of some side effects may be increased. Also, the caffeine present in some aspirin products can make some kinds of heart disease worse.

  • Hemophilia or other bleeding problems—The chance of bleeding may be increased, especially with aspirin.

Proper Use of salicylate

This section provides information on the proper use of a number of products that contain salicylate. It may not be specific to Pepto-Bismol. Please read with care.


Take this medicine after meals or with food (except for enteric-coated capsules or tablets and aspirin suppositories) to lessen stomach irritation.


Take tablet or capsule forms of this medicine with a full glass (8 ounces) of water. Also, do not lie down for about 15 to 30 minutes after swallowing the medicine. This helps to prevent irritation that may lead to trouble in swallowing.


For patients taking aspirin (including buffered aspirin and/or products containing caffeine):


  • Do not use any product that contains aspirin if it has a strong, vinegar-like odor. This odor means the medicine is breaking down. If you have any questions about this, check with your health care professional.

  • If you are to take any medicine that contains aspirin within 7 days after having your tonsils removed, a tooth pulled, or other dental or mouth surgery, be sure to swallow the aspirin whole. Do not chew aspirin during this time.

  • Do not place any medicine that contains aspirin directly on a tooth or gum surface. This may cause a burn.

  • There are several different forms of aspirin or buffered aspirin tablets. If you are using:
    • chewable aspirin tablets, they may be chewed, dissolved in liquid, crushed, or swallowed whole.

    • delayed-release (enteric-coated) aspirin tablets, they must be swallowed whole. Do not crush them or break them up before taking.

    • extended-release (long-acting) aspirin tablets, check with your pharmacist as to how they should be taken. Some may be broken up (but must not be crushed) before swallowing if you cannot swallow them whole. Others should not be broken up and must be swallowed whole.


To use aspirin suppositories:


  • If the suppository is too soft to insert, chill it in the refrigerator for 30 minutes or run cold water over it before removing the foil wrapper.

  • To insert the suppository: First remove the foil wrapper and moisten the suppository with cold water. Lie down on your side and use your finger to push the suppository well up into the rectum.

To take choline and magnesium salicylates (e.g., Trilisate) oral solution:


  • The liquid may be mixed with fruit juice just before taking.

  • Drink a full glass (8 ounces) of water after taking the medicine.

To take enteric-coated sodium salicylate tablets:


  • The tablets must be swallowed whole. Do not crush them or break them up before taking.

Unless otherwise directed by your medical doctor or dentist:


  • Do not take more of this medicine than recommended on the label, to lessen the chance of side effects.

  • Children up to 12 years of age should not take this medicine more than 5 times a day.

When used for arthritis (rheumatism), this medicine must be taken regularly as ordered by your doctor in order for it to help you. Up to 2 to 3 weeks or longer may pass before you feel the full effects of this medicine.


Dosing


The dose medicines in this class will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of these medicines. If your dose is different, do not change it unless your doctor tells you to do so.


The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.


  • For aspirin

  • For oral dosage forms (short-acting tablets, chewable tablets, and delayed-release [enteric-coated] tablets):
    • For pain or fever:
      • Adults and teenagers—325 to 500 milligrams (mg) every three or four hours, 650 mg every four to six hours, or 1000 mg every six hours as needed.

      • Children 11 to 12 years of age—320 to 480 mg every four hours as needed.

      • Children 9 to 11 years of age—320 to 400 mg every four hours as needed.

      • Children 6 to 9 years of age—320 to 325 mg every four hours as needed.

      • Children 4 to 6 years of age—240 mg every four hours as needed.

      • Children 2 to 4 years of age—160 mg every four hours as needed.

      • Children up to 2 years of age—Dose must be determined by your doctor.


    • For arthritis:
      • Adults and teenagers—A total of 3600 to 5400 mg a day, divided into several smaller doses.

      • Children—A total of 80 to 100 mg per kilogram (kg) (32 to 40 mg per pound) of body weight a day, divided into several smaller doses.


    • For preventing a heart attack, stroke, or other problems caused by blood clots:
      • Adults—Most people will take 81, 162.5, or 325 mg a day or 325 mg every other day. Some people taking aspirin to prevent a stroke may need as much as 1000 mg a day.

      • Children—Use and dose must be determined by your doctor.



  • For oral dosage form (chewing gum):
    • For pain:
      • Adults and teenagers—2 tablets every four hours as needed.

      • Children 6 to 12 years of age—1 or 2 tablets (227 mg each) up to four times a day.

      • Children 3 to 6 years of age—1 tablet (227 mg) up to three times a day.

      • Children up to 3 years of age—Dose must be determined by your doctor.



  • For long-acting oral dosage form (extended-release tablets):
    • For pain:
      • Adults and teenagers—1 or 2 tablets twice a day.

      • Children—The long-acting aspirin tablets are too strong for use in children.


    • For arthritis:
      • Adults and teenagers—1 or 2 tablets twice a day, at first. Your doctor will then adjust your dose as needed.

      • Children—The long-acting aspirin tablets are too strong for use in children.



  • For rectal dosage form (suppositories):
    • For pain or fever:
      • Adults and teenagers—325 to 650 mg every four hours as needed.

      • Children 11 to 12 years of age—325 to 480 mg every four hours as needed.

      • Children 9 to 11 years of age—325 to 400 mg every four hours as needed.

      • Children 6 to 9 years of age—325 mg every four hours as needed.

      • Children 4 to 6 years of age—240 mg every four hours as needed.

      • Children 2 to 4 years of age—160 mg every four hours as needed.

      • Children up to 2 years of age—Dose must be determined by your doctor.


    • For arthritis:
      • Adults and teenagers—A total of 3600 to 5400 mg a day, divided into several smaller doses.

      • Children—A total of 80 to 100 mg per kilogram (kg) (32 to 40 mg per pound) of body weight a day, divided into several smaller doses.



  • For aspirin and caffeine

  • For oral dosage forms (capsule):
    • For pain or fever:
      • Adults and teenagers—325 to 500 milligrams (mg) of aspirin every three or four hours, 650 mg of aspirin every four to six hours, or 1000 mg of aspirin every six hours as needed.

      • Children 9 to 12 years of age—325 to 400 mg every four hours as needed.

      • Children 6 to 9 years of age—325 mg every four hours as needed.

      • Children up to 6 years of age—Aspirin and caffeine capsules are too strong for use in children up to 6 years of age


    • For preventing a heart attack, stroke, or other problems caused by blood clots:
      • Adults—325 mg a day or every other day. People who take smaller doses of aspirin will have to use a different product. Some people taking aspirin to prevent a stroke may need as much as 1000 mg a day.

      • Children—Use and dose must be determined by your doctor.



  • For oral dosage form (tablets):
    • For pain or fever:
      • Adults and teenagers—325 to 500 mg of aspirin every three or four hours, 650 mg of aspirin every four to six hours, or 1000 mg of aspirin every six hours as needed.

      • Children 9 to 12 years of age—325 to 400 mg every four hours as needed.

      • Children up to 9 years of age—Aspirin and caffeine tablets are too strong for use in children up to 9 years of age.


    • For arthritis:
      • Adults and teenagers—A total of 3600 to 5400 mg of aspirin a day, divided into several smaller doses.

      • Children—A total of 80 to 100 mg per kg (32 to 40 mg per pound) of body weight a day, divided into several smaller doses.


    • For preventing a heart attack, stroke, or other problems caused by blood clots:
      • Adults—325 mg a day or every other day. People who take smaller doses of aspirin will have to use a different product. Some people taking aspirin to prevent a stroke may need as much as 1000 mg a day.

      • Children—Use and dose must be determined by your doctor.



  • For buffered aspirin

  • For oral dosage forms (tablets):
    • For pain or fever:
      • Adults and teenagers—325 to 500 milligrams (mg) of aspirin every three or four hours, 650 mg of aspirin every four to six hours, or 1000 mg of aspirin every six hours as needed.

      • Children 11 to 12 years of age—One or one and one-half 325-mg tablets every four hours as needed.

      • Children 9 to 11 years of age—One or one and one-fourth 325-mg tablets every four hours as needed.

      • Children 6 to 9 years of age—One 325-mg tablet every four hours as needed.

      • Children 4 to 6 years of age—Three-fourths of a 325-mg tablet every four hours as needed.

      • Children 2 to 4 years of age—One-half of a 325-mg tablet every four hours as needed.

      • Children up to 2 years of age—Dose must be determined by your doctor.


    • For arthritis:
      • Adults and teenagers—A total of 3600 to 5400 mg of aspirin a day, divided into several smaller doses.

      • Children—A total of 80 to 100 mg per kilogram (kg) (32 to 40 mg per pound) of body weight a day, divided into several smaller doses.


    • For preventing a heart attack, stroke, or other problems caused by blood clots:
      • Adults—325 mg a day or every other day. People who take smaller doses of aspirin will have to use a different product. Some people taking aspirin to prevent a stroke may need as much as 1000 mg a day.

      • Children—Use and dose must be determined by your doctor.



  • For buffered aspirin and caffeine

  • For oral dosage form (tablets):
    • For pain or fever:
      • Adults and teenagers—325 or 421 milligrams (mg) of aspirin every three or four hours, 650 mg of aspirin every four to six hours, or 842 mg of aspirin every six hours as needed.

      • Children 11 to 12 years of age—One or one and one-half 325-mg tablets, or one 421-mg tablet, every four hours as needed.

      • Children 9 to 11 years of age—One or one and one-fourth 325-mg tablets every four hours as needed.

      • Children 6 to 9 years of age—One 325-mg or 421-mg tablet every four hours as needed.

      • Children 4 to 6 years of age—Three-fourths of a 325-mg tablet every four hours as needed.

      • Children 2 to 4 years of age—One-half of a 325-mg tablet every four hours as needed.

      • Children up to 2 years of age—Dose must be determined by your doctor.


    • For arthritis:
      • Adults and teenagers—A total of 3600 to 5400 mg of aspirin a day, divided into several smaller doses.

      • Children—A total of 80 to 100 mg per kilogram (kg) (32 to 40 mg per pound) of body weight a day, divided into several smaller doses.


    • For preventing a heart attack, stroke, or other problems caused by blood clots:
      • Adults—162.5 or 325 mg (one-half or one 325-mg tablet) a day or 325 mg every other day. People who need smaller doses of aspirin will have to use a different product. Some people taking aspirin to prevent a stroke may need as much as 1000 mg a day.

      • Children—Use and dose must be determined by your doctor.



  • For choline salicylate

  • For oral dosage form (oral solution):
    • For pain or fever:
      • Adults and teenagers—One-half or three-fourths of a teaspoonful every three hours, one-half or one teaspoonful every four hours, or one or one and one-half teaspoonfuls every six hours as needed.

      • Children 11 to 12 years of age—2.5 to 3.75 mL (one-half to three-fourths of a teaspoonful) every four hours as needed. This amount should be measured by a special measuring spoon.

      • Children 6 to 11 years of age—2.5 mL (one-half of a teaspoonful) every four hours as needed. This amount should be measured by a special measuring spoon.

      • Children 4 to 6 years of age—1.66 mL every four hours as needed. This amount should be measured by a special dropper or measuring spoon.

      • Children 2 to 4 years of age—1.25 milliliters (mL) (one-fourth of a teaspoonful) every four hours as needed. This amount should be measured by a special dropper or measuring spoon.

      • Children up to 2 years of age—Dose must be determined by your doctor.


    • For arthritis:
      • Adults—A total of five and one-half to eight teaspoonfuls a day, divided into several smaller doses.

      • Children—A total of 0.6 to 0.7 mL per kilogram (kg) (0.25 to 0.28 mL per pound) of body weight a day, divided into several smaller doses.



  • For choline and magnesium salicylates

  • For oral dosage forms (oral solution or tablets):
    • For pain or fever:
      • Adults and teenagers—A total of 2000 to 3000 milligrams (mg) a day, divided into two or three doses.

      • Children weighing more than 37 kg (90 pounds or more)—2200 mg a day, divided into two doses.

      • Children weighing up to 37 kilograms (kg) (about 89 pounds)—A total of 50 mg per kg (20 mg per pound) of body weight a day, divided into two doses.



  • For magnesium salicylate

  • For oral dosage form (tablets):
    • For pain:
      • Adults and teenagers—2 regular-strength tablets every four hours, up to a maximum of 12 tablets a day, or 2 extra-strength tablets every eight hours, up to a maximum of 8 tablets a day.

      • Children—Dose must be determined by your doctor.



  • For salsalate

  • For oral dosage forms (capsules or tablets):
    • For arthritis:
      • Adults and teenagers—500 to 1000 milligrams (mg) two or three times a day, to start. Your doctor will then adjust your dose as needed.

      • Children—Dose must be determined by your doctor.



  • For sodium salicylate

  • For oral dosage forms (tablets or delayed-release [enteric-coated] tablets):
    • For pain or fever:
      • Adults and teenagers—325 or 650 milligrams (mg) every four hours as needed.

      • Children 6 years of age and older—325 mg every four hours as needed.

      • Children up to 6 years of age—This medicine is too strong for use in children younger than 6 years of age.


    • For arthritis:
      • Adults and teenagers—A total of 3600 to 5400 mg a day, divided into several smaller doses.

      • Children—A total of 80 to 100 mg per kilogram (kg) (32 to 40 mg per pound) of body weight a day, divided into several smaller doses.



Missed Dose


If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.


Storage


Keep out of the reach of children.


Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.


Do not keep outdated medicine or medicine no longer needed.


Precautions While Using Pepto-Bismol


Check the labels of all nonprescription (over-the-counter [OTC]) and prescription medicines you now take. If any contain aspirin or other salicylates (including bismuth subsalicylate [e.g., Pepto-Bismol] or any shampoo or skin medicine that contains salicylic acid or any other salicylate), check with your health care professional. Taking or using them together with this medicine may cause an overdose.


If you will be taking salicylates for a long time (more than 5 days in a row for children or 10 days in a row for adults) or in large amounts, your doctor should check your progress at regular visits.


Serious side effects can occur during treatment with this medicine. Sometimes serious side effects can occur without any warning. However, possible warning signs often occur, including swelling of the face, fingers, feet, and/or lower legs; severe stomach pain, black, tarry stools, and/or vomiting of blood or material that looks like coffee grounds; unusual weight gain; and/or skin rash. Also, signs of serious heart problems could occur such as chest pain, tightness in chest, fast or irregular heartbeat, or unusual flushing or warmth of skin. Stop taking this medicine and check with your doctor immediately if you notice any of these warning signs.


Check with your medical doctor or dentist:


  • If you are taking this medicine to relieve pain and the pain lasts for more than 10 days (5 days for children) or if the pain gets worse, if new symptoms occur, or if redness or swelling is present. These could be signs of a serious condition that needs medical or dental treatment.

  • If you are taking this medicine to bring down a fever, and the fever lasts for more than 3 days or returns, if the fever gets worse, if new symptoms occur, or if redness or swelling is present. These could be signs of a serious condition that needs treatment.

  • If you are taking this medicine for a sore throat, and the sore throat is very painful, lasts for more than 2 days, or occurs together with or is followed by fever, headache, skin rash, nausea, or vomiting.

  • If you are taking this medicine regularly, as for arthritis (rheumatism), and you notice a ringing or buzzing in your ears or severe or continuing headaches. These are often the first signs that too much salicylate is being taken. Your doctor may want to change the amount of medicine you are taking every day.

For patients taking aspirin to lessen the chance of heart attack, stroke, or other problems caused by blood clots:


  • Take only the amount of aspirin ordered by your doctor. If you need a medicine to relieve pain, a fever, or arthritis, your doctor may not want you to take extra aspirin. It is a good idea to discuss this with your doctor, so that you will know ahead of time what medicine to take.

  • Do not stop taking this medicine for any reason without first checking with the doctor who directed you to take it.

Taking certain other medicines together with a salicylate may increase the chance of unwanted effects. The risk will depend on how much of each medicine you take every day, and on how long you take the medicines together. If your doctor directs you to take these medicines together on a regular basis, follow his or her directions carefully. However, do not take any of the following medicines together with a salicylate for more than a few days, unless your doctor has directed you to do so and is following your progress:


  • Acetaminophen (e.g., Tylenol)

  • Diclofenac (e.g., Voltaren)

  • Diflunisal (e.g., Dolobid)

  • Etodolac (e.g., Lodine)

  • Fenoprofen (e.g., Nalfon)

  • Floctafenine (e.g., Idarac)

  • Flurbiprofen, oral (e.g., Ansaid)

  • Ibuprofen (e.g., Motrin)

  • Indomethacin (e.g., Indocin)

  • Ketoprofen (e.g., Orudis)

  • Ketorolac (e.g., Toradol)

  • Meclofenamate (e.g., Meclomen)

  • Mefenamic acid (e.g., Ponstel)

  • Nabumetone (e.g., Relafen)

  • Naproxen (e.g., Naprosyn)

  • Oxaprozin (e.g., Daypro)

  • Phenylbutazone (e.g., Butazolidin)

  • Piroxicam (e.g., Feldene)

  • Sulindac (e.g., Clinoril)

  • Tenoxicam (e.g., Mobiflex)

  • Tiaprofenic acid (e.g., Surgam)

  • Tolmetin (e.g., Tolectin)

For diabetic patients:


  • False urine sugar test results may occur if you are regularly taking large amounts of salicylates, such as:
    • Aspirin: 8 or more 325-mg (5-grain), or 4 or more 500-mg or 650-mg (10-grain), or 3 or more 800-mg (or higher strength), doses a day.

    • Buffered aspirin or

    • Sodium salicylate: 8 or more 325-mg (5-grain), or 4 or more 500-mg or 650-mg (10-grain), doses a day.

    • Choline salicylate: 4 or more teaspoonfuls (each teaspoonful containing 870 mg) a day.

    • Choline and magnesium salicylates: 5 or more 500-mg tablets or teaspoonfuls, 4 or more 750-mg tablets, or 2 or more 1000-mg tablets, a day.

    • Magnesium salicylate: 7 or more regular-strength, or 4 or more extra-strength, tablets a day.

    • Salsalate: 4 or more 500-mg doses, or 3 or more 750-mg doses, a day.


  • Smaller doses or occasional use of salicylates usually will not affect urine sugar tests. However, check with your health care professional (especially if your diabetes is not well-controlled) if:
    • you are not sure how much salicylate you are taking every day.

    • you notice any change in your urine sugar test results.

    • you have any other questions about this possible problem.


Do not take aspirin for 5 days before any surgery, including dental surgery, unless otherwise directed by your medical doctor or dentist. Taking aspirin during this time may cause bleeding problems.


For patients taking buffered aspirin, choline and magnesium salicylates (e.g., Trilisate), or magnesium salicylate (e.g., Doan's):


  • Buffered aspirin, choline and magnesium salicylates, or magnesium salicylate can keep many other medicines, especially some medicines used to treat infections, from working properly. This problem can be prevented by not taking the 2 medicines too close together. Ask your health care professional how long you should wait between taking a medicine for infection and taking buffered aspirin, choline and magnesium salicylates, or magnesium salicylate.

If you are taking a laxative containing cellulose, take the salicylate at least 2 hours before or after you take the laxative. Taking these medicines too close together may lessen the effects of the salicylate.


For patients taking this medicine by mouth:


  • Stomach problems may be more likely to occur if you drink alcoholic beverages while being treated with this medicine, especially if you are taking it in high doses or for a long time. Check with your doctor if you have any questions about this.

For patients using aspirin suppositories:


  • Aspirin suppositories may cause irritation of the rectum. Check with your doctor if this occurs.

Salicylates may interfere with the results of some medical tests. Before you have any medical tests, tell the doctor in charge if you have taken any of these medicines within the past week. If possible, it is best to check with the doctor first, to find out whether the medicine may be taken during the week before the test.


For patients taking one of the products that contain caffeine:


  • Caffeine may interfere with the result of a test that uses adenosine (e.g., Adenocard) or dipyridamole (e.g., Persantine) to help find out how well your blood is flowing through certain blood vessels. Therefore, you should not have any caffeine for at least 8 to 12 hours before the test.

If you think that you or anyone else may have taken an overdose, get emergency help at once. Taking an overdose of these medicines may cause unconsciousness or death. Signs of overdose include convulsions (seizures), hearing loss, confusion, ringing or buzzing in the ears, severe drowsiness or tiredness, severe excitement or nervousness, and fast or deep breathing.


Pepto-Bismol Side Effects


Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.


Get emergency help immediately if any of the following side effects occur:


Symptoms of overdose in children
  • Changes in behavior

  • drowsiness or tiredness (severe)

  • fast or deep breathing

  • Any loss of hearing

  • bloody urine

  • confusion

  • convulsions (seizures)

  • diarrhea (severe or continuing)

  • difficulty in swallowing

  • dizziness, lightheadedness, or feeling faint (severe)

  • drowsiness (severe)

  • excitement or nervousness (severe)

  • fast or deep breathing

  • flushing, redness, or other change in skin color

  • hallucinations (seeing, hearing, or feeling things that are not there)

  • increased sweating

  • increased thirst

  • nausea or vomiting (severe or continuing)

  • shortness of breath, troubled breathing, tightness in chest, or wheezing

  • stomach pain (severe or continuing)

  • swelling of eyelids, face, or lips

  • unexplained fever

  • uncontrollable flapping movements of the hands (especially in elderly patients)

  • vision problems

Check with your doctor as soon as possible if any of the following side effects occur:


Less common or rare
  • Abdominal or stomach pain, cramping, or burning (severe)

  • bloody or black, tarry stools

  • headache (severe or continuing)

  • ringing or buzzing in ears (continuing)

  • skin rash, hives, or itching

  • unusual tiredness or weakness

  • vomiting of blood or material that looks like coffee grounds

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:


More common
  • Abdominal or stomach cramps, pain, or discomfort (mild to moderate)

  • heartburn or indigestion

  • nausea or vomiting

Less common
  • Trouble in sleeping, nervousness, or jitters (only for products containing caffeine)

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.


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



The information contained in the Thomson Reuters Micromedex products as delivered by Drugs.com is intended as an educational aid only. It is not intended as medical advice for individual conditions or treatment. It is not a substitute for a medical exam, nor does it replace the need for services provided by medical professionals. Talk to your doctor, nurse or pharmacist before taking any prescription or over the counter drugs (including any herbal medicines or supplements) or following any treatment or regimen. Only your doctor, nurse, or pharmacist can provide you with advice on what is safe and effective for you.


The use of the Thomson Reuters Healthcare products is at your sole risk. These products are provided "AS IS" and "as available" for use, without warranties of any kind, either express or implied. Thomson Reuters Healthcare and Drugs.com make no representation or warranty as to the accuracy, reliability, timeliness, usefulness or completeness of any of the information contained in the products. Additionally, THOMSON REUTERS HEALTHCARE MAKES NO REPRESENTATION OR WARRANTIES AS TO THE OPINIONS OR OTHER SERVICE OR DATA YOU MAY ACCESS, DOWNLOAD OR USE AS A RESULT OF USE OF THE THOMSON REUTERS HEALTHCARE PRODUCTS. ALL IMPLIED WARRANTIES OF MERCHANTABILITY AND FITNESS FOR A PARTICULAR PURPOSE OR USE ARE HEREBY EXCLUDED. Thomson Reuters Healthcare does not assume any responsibility or risk for your use of the Thomson Reuters Healthcare products.

Phenergan




Generic Name: promethazine hydrochloride

Dosage Form: Tablets and Suppositories

Rx only



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 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 freely soluble in water and soluble in alcohol.



CLINICAL PHARMACOLOGY


Promethazine is a phenothiazine derivative which differs structurally from the antipsychotic phenothiazines by the presence of a branched side chain and no ring substitution. It is thought that this configuration is responsible for its relative lack (1/10 that of chlorpromazine) of dopamine antagonist properties.


Promethazine is an H1 receptor blocking agent. In addition to its antihistaminic action, it provides clinically useful sedative and antiemetic effects.


Promethazine is well absorbed from the gastrointestinal tract. Clinical effects are apparent within 20 minutes after oral administration and generally last four to six hours, although they may persist as long as 12 hours. Promethazine is metabolized by the liver to a variety of compounds; the sulfoxides of promethazine and N-demethylpromethazine are the predominant metabolites appearing in the urine.



INDICATIONS AND USAGE


Phenergan, either orally or by suppository, is useful for:


Perennial and seasonal allergic rhinitis.


Vasomotor rhinitis.


Allergic conjunctivitis due to inhalant allergens and foods.


Mild, uncomplicated allergic skin manifestations of urticaria and angioedema.


Amelioration of allergic reactions to blood or plasma.


Dermographism.


Anaphylactic reactions, as adjunctive therapy to epinephrine and other standard measures, after the acute manifestations have been controlled.


Preoperative, postoperative, or obstetric sedation.


Prevention and control of nausea and vomiting associated with certain types of anesthesia and surgery.


Therapy adjunctive to meperidine or other analgesics for control of post-operative pain.


Sedation in both children and adults, as well as relief of apprehension and production of light sleep from which the patient can be easily aroused.


Active and prophylactic treatment of motion sickness.


Antiemetic therapy in postoperative patients.



CONTRAINDICATIONS


Phenergan Tablets and Suppositories are contraindicated for use in pediatric patients less than two years of age.


Phenergan Tablets and Suppositories are contraindicated in comatose states, and in individuals known to be hypersensitive or to have had an idiosyncratic reaction to promethazine or to other phenothiazines.


Antihistamines are contraindicated for use in the treatment of lower respiratory tract symptoms including asthma.



WARNINGS




Phenergan SHOULD NOT BE USED IN PEDIATRIC PATIENTS LESS THAN 2 YEARS OF AGE BECAUSE OF THE POTENTIAL FOR FATAL RESPIRATORY DEPRESSION.


POSTMARKETING CASES OF RESPIRATORY DEPRESSION, INCLUDING FATALITIES, HAVE BEEN REPORTED WITH USE OF Phenergan IN PEDIATRIC PATIENTS LESS THAN 2 YEARS OF AGE. A WIDE RANGE OF WEIGHT-BASED DOSES OF Phenergan HAVE RESULTED IN RESPIRATORY DEPRESSION IN THESE PATIENTS.


CAUTION SHOULD BE EXERCISED WHEN ADMINISTERING Phenergan TO PEDIATRIC PATIENTS 2 YEARS OF AGE AND OLDER. IT IS RECOMMENDED THAT THE LOWEST EFFECTIVE DOSE OF Phenergan BE USED IN PEDIATRIC PATIENTS 2 YEARS OF AGE AND OLDER AND CONCOMITANT ADMINISTRATION OF OTHER DRUGS WITH RESPIRATORY DEPRESSANT EFFECTS BE AVOIDED.




CNS Depression


Phenergan Tablets and Suppositories may impair the mental and/or physical abilities required for the performance of potentially hazardous tasks, such as driving a vehicle or operating machinery. The impairment may be amplified by concomitant use of other central-nervous-system depressants such as alcohol, sedatives/hypnotics (including barbiturates), narcotics, narcotic analgesics, general anesthetics, tricyclic antidepressants, and tranquilizers; therefore such agents should either be eliminated or given in reduced dosage in the presence of promethazine HCl (see PRECAUTIONS−Information for Patients and Drug Interactions).



Respiratory Depression


Phenergan Tablets and Suppositories may lead to potentially fatal respiratory depression.


Use of Phenergan Tablets and Suppositories in patients with compromised respiratory function (e.g., COPD, sleep apnea) should be avoided.



Lower Seizure Threshold


Phenergan Tablets and Suppositories may lower seizure threshold. It should be used with caution in persons with seizure disorders or in persons who are using concomitant medications, such as narcotics or local anesthetics, which may also affect seizure threshold.



Bone-Marrow Depression


Phenergan Tablets and Suppositories should be used with caution in patients with bone-marrow depression. Leukopenia and agranulocytosis have been reported, usually when Phenergan has been used in association with other known marrow-toxic agents.



Neuroleptic Malignant Syndrome


A potentially fatal symptom complex sometimes referred to as Neuroleptic Malignant Syndrome (NMS) has been reported in association with promethazine HCl alone or in combination with antipsychotic drugs. Clinical manifestations of NMS are hyperpyrexia, muscle rigidity, altered mental status and evidence of autonomic instability (irregular pulse or blood pressure, tachycardia, diaphoresis and cardiac dysrhythmias).


The diagnostic evaluation of patients with this syndrome is complicated. In arriving at a diagnosis, it is important to identify cases where the clinical presentation includes both serious medical illness (e.g. pneumonia, systemic infection, etc.) and untreated or inadequately treated extrapyramidal signs and symptoms (EPS). Other important considerations in the differential diagnosis include central anticholinergic toxicity, heat stroke, drug fever and primary central nervous system (CNS) pathology.


The management of NMS should include 1) immediate discontinuation of promethazine HCl, antipsychotic drugs, if any, and other drugs not essential to concurrent therapy, 2) intensive symptomatic treatment and medical monitoring, and 3) treatment of any concomitant serious medical problems for which specific treatments are available. There is no general agreement about specific pharmacological treatment regimens for uncomplicated NMS.


Since recurrences of NMS have been reported with phenothiazines, the reintroduction of promethazine HCl should be carefully considered.



Use in Pediatric Patients


Phenergan TABLETS AND SUPPOSITORIES ARE CONTRAINDICATED FOR USE IN PEDIATRIC PATIENTS LESS THAN TWO YEARS OF AGE.


CAUTION SHOULD BE EXERCISED WHEN ADMINISTERING Phenergan TABLETS AND SUPPOSITORIES TO PEDIATRIC PATIENTS 2 YEARS OF AGE AND OLDER BECAUSE OF THE POTENTIAL FOR FATAL RESPIRATORY DEPRESSION. RESPIRATORY DEPRESSION AND APNEA, SOMETIMES ASSOCIATED WITH DEATH, ARE STRONGLY ASSOCIATED WITH PROMETHAZINE PRODUCTS AND ARE NOT DIRECTLY RELATED TO INDIVIDUALIZED WEIGHT-BASED DOSING, WHICH MIGHT OTHERWISE PERMIT SAFE ADMINISTRATION. CONCOMITANT ADMINISTRATION OF PROMETHAZINE PRODUCTS WITH OTHER RESPIRATORY DEPRESSANTS HAS AN ASSOCIATION WITH RESPIRATORY DEPRESSION, AND SOMETIMES DEATH, IN PEDIATRIC PATIENTS.


ANTIEMETICS ARE NOT RECOMMENDED FOR TREATMENT OF UNCOMPLICATED VOMITING IN PEDIATRIC PATIENTS, AND THEIR USE SHOULD BE LIMITED TO PROLONGED VOMITING OF KNOWN ETIOLOGY. THE EXTRAPYRAMIDAL SYMPTOMS WHICH CAN OCCUR SECONDARY TO Phenergan TABLETS AND SUPPOSITORIES ADMINISTRATION MAY BE CONFUSED WITH THE CNS SIGNS OF UNDIAGNOSED PRIMARY DISEASE, e.g., ENCEPHALOPATHY OR REYE'S SYNDROME. THE USE OF Phenergan TABLETS AND SUPPOSITORIES SHOULD BE AVOIDED IN PEDIATRIC PATIENTS WHOSE SIGNS AND SYMPTOMS MAY SUGGEST REYE'S SYNDROME OR OTHER HEPATIC DISEASES.


Excessively large dosages of antihistamines, including Phenergan Tablets and Suppositories, in pediatric patients may cause sudden death (see OVERDOSAGE). Hallucinations and convulsions have occurred with therapeutic doses and overdoses of Phenergan in pediatric patients. In pediatric patients who are acutely ill associated with dehydration, there is an increased susceptibility to dystonias with the use of promethazine HCl.



Other Considerations


Administration of promethazine HCl has been associated with reported cholestatic jaundice.


PRECAUTIONS

General


Drugs having anticholinergic properties should be used with caution in patients with narrow-angle glaucoma, prostatic hypertrophy, stenosing peptic ulcer, pyloroduodenal obstruction, and bladder-neck obstruction.


Phenergan Tablets and Suppositories should be used cautiously in persons with cardiovascular disease or with impairment of liver function.



Information for Patients


Phenergan Tablets and Suppositories may cause marked drowsiness or impair the mental and/or physical abilities required for the performance of potentially hazardous tasks, such as driving a vehicle or operating machinery. The use of alcohol or other central-nervous-system depressants such as sedatives/hypnotics (including barbiturates), narcotics, narcotic analgesics, general anesthetics, tricyclic antidepressants, and tranquilizers, may enhance impairment (see WARNINGS-CNS Depression and PRECAUTIONS-Drug Interactions). Pediatric patients should be supervised to avoid potential harm in bike riding or in other hazardous activities.


Patients should be advised to report any involuntary muscle movements.


Avoid prolonged exposure to the sun.



Drug Interactions



CNS Depressants - Phenergan Tablets and Suppositories may increase, prolong, or intensify the sedative action of other central-nervous-system depressants, such as alcohol, sedatives/hypnotics (including barbiturates), narcotics, narcotic analgesics, general anesthetics, tricyclic antidepressants, and tranquilizers; therefore, such agents should be avoided or administered in reduced dosage to patients receiving promethazine HCl. When given concomitantly with Phenergan Tablets and Suppositories, the dose of barbiturates should be reduced by at least one-half, and the dose of narcotics should be reduced by one-quarter to one-half. Dosage must be individualized. Excessive amounts of promethazine HCl relative to a narcotic may lead to restlessness and motor hyperactivity in the patient with pain; these symptoms usually disappear with adequate control of the pain.



Epinephrine - Because of the potential for Phenergan to reverse epinephrine's vasopressor effect, epinephrine should NOT be used to treat hypotension associated with Phenergan Tablets and Suppositories overdose.



Anticholinergics - Concomitant use of other agents with anticholinergic properties should be undertaken with caution.



Monoamine Oxidase Inhibitors (MAOI) - Drug interactions, including an increased incidence of extrapyramidal effects, have been reported when some MAOI and phenothiazines are used concomitantly. This possibility should be considered with Phenergan Tablets and Suppositories.



Drug/Laboratory Test Interactions


The following laboratory tests may be affected in patients who are receiving therapy with promethazine HCl:


Pregnancy Tests

Diagnostic pregnancy tests based on immunological reactions between HCG and anti-HCG may result in false-negative or false-positive interpretations.


Glucose Tolerance Test

An increase in blood glucose has been reported in patients receiving promethazine HCl.



Carcinogenesis, Mutagenesis, Impairment of Fertility


Long-term animal studies have not been performed to assess the carcinogenic potential of promethazine, nor are there other animal or human data concerning carcinogenicity, mutagenicity, or impairment of fertility with this drug. Promethazine was nonmutagenic in the Salmonella test system of Ames.



Pregnancy


Teratogenic Effects-Pregnancy Category C

Teratogenic effects have not been demonstrated in rat-feeding studies at doses of 6.25 and 12.5 mg/kg of promethazine HCl. These doses are from approximately 2.1 to 4.2 times the maximum recommended total daily dose of promethazine for a 50-kg subject, depending upon the indication for which the drug is prescribed. Daily doses of 25 mg/kg intraperitoneally have been found to produce fetal mortality in rats.


Specific studies to test the action of the drug on parturition, lactation, and development of the animal neonate were not done, but a general preliminary study in rats indicated no effect on these parameters. Although antihistamines have been found to produce fetal mortality in rodents, the pharmacological effects of histamine in the rodent do not parallel those in man. There are no adequate and well-controlled studies of Phenergan® Tablets and Suppositories in pregnant women.


Phenergan Tablets and Suppositories should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.


Nonteratogenic Effects

Phenergan Tablets and Suppositories administered to a pregnant woman within two weeks of delivery may inhibit platelet aggregation in the newborn.



Labor and Delivery


Promethazine HCl may be used alone or as an adjunct to narcotic analgesics during labor (see DOSAGE AND ADMINISTRATION). Limited data suggest that use of Phenergan during labor and delivery does not have an appreciable effect on the duration of labor or delivery and does not increase the risk of need for intervention in the newborn. The effect on later growth and development of the newborn is unknown. (See also Nonteratogenic Effects.)



Nursing Mothers


It is not known whether promethazine HCl is excreted in human milk. Because many drugs are excreted in human milk and because of the potential for serious adverse reactions in nursing infants from Phenergan Tablets and Suppositories, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.



Pediatric Use


Phenergan TABLETS AND SUPPOSITORIES ARE CONTRAINDICATED FOR USE IN PEDIATRIC PATIENTS LESS THAN TWO YEARS OF AGE (see WARNINGS–Black Box Warning and Use in Pediatric Patients).


Phenergan Tablets and Suppositories should be used with caution in pediatric patients 2 years of age and older (see WARNINGS-Use in Pediatric Patients).



Geriatric Use


Clinical studies of Phenergan formulations did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Other reported clinical experience has not identified differences in responses between the elderly and younger patients. In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal or cardiac function, and of concomitant disease or other drug therapy.


Sedating drugs may cause confusion and over-sedation in the elderly; elderly patients generally should be started on low doses of Phenergan Tablets and Suppositories and observed closely.



Adverse Reactions



Central Nervous System


Drowsiness is the most prominent CNS effect of this drug. Sedation, somnolence, blurred vision, dizziness; confusion, disorientation, and extrapyramidal symptoms such as oculogyric crisis, torticollis, and tongue protrusion; lassitude, tinnitus, incoordination, fatigue, euphoria, nervousness, diplopia, insomnia, tremors, convulsive seizures, excitation, catatonic-like states, hysteria. Hallucinations have also been reported.


Cardiovascular–Increased or decreased blood pressure, tachycardia, bradycardia, faintness.


Dermatologic–Dermatitis, photosensitivity, urticaria.


Hematologic–Leukopenia, thrombocytopenia, thrombocytopenic purpura, agranulocytosis.


Gastrointestinal –Dry mouth, nausea, vomiting, jaundice.


Respiratory –Asthma, nasal stuffiness, respiratory depression (potentially fatal) and apnea (potentially fatal). (See WARNINGS-Respiratory Depression.)


Other –Angioneurotic edema. Neuroleptic malignant syndrome (potentially fatal) has also been reported. (See WARNINGS-Neuroleptic Malignant Syndrome.)



Paradoxical Reactions


Hyperexcitability and abnormal movements have been reported in patients following a single administration of promethazine HCl. Consideration should be given to the discontinuation of promethazine HCl and to the use of other drugs if these reactions occur. Respiratory depression, nightmares, delirium, and agitated behavior have also been reported in some of these patients.



OVERDOSAGE


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.



DOSAGE AND ADMINISTRATION


Phenergan Tablets and Phenergan Rectal Suppositories are contraindicated for children under 2 years of age (see WARNINGS–Black Box Warning and Use in Pediatric Patients).


Phenergan Suppositories are for rectal administration only.



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 to relieve symptoms. The administration of promethazine HCl in 25-mg doses will control minor transfusion reactions of an allergic nature.



Motion Sickness


The average adult dose is 25 mg taken twice daily. The initial dose should be taken one-half to one hour before anticipated travel and be repeated 8 to 12 hours later, if necessary. On succeeding days of travel, it is recommended that 25 mg be given on arising and again before the evening meal. For children, Phenergan Tablets, Syrup, or Rectal Suppositories, 12.5 to 25 mg, twice daily, may be administered.



Nausea and Vomiting


Antiemetics should not be used in vomiting of unknown etiology in children and adolescents (see WARNINGS-Use in Pediatric Patients).


The average effective dose of Phenergan for the active therapy of nausea and vomiting in children or adults is 25 mg. When oral medication cannot be tolerated, the dose should be given parenterally (cf. Phenergan Injection) or by rectal suppository. 12.5- to 25-mg doses may be repeated, as necessary, at 4- to 6-hour intervals.


For nausea and vomiting in children, the usual dose is 0.5 mg per pound of body weight, and the dose should be adjusted to the age and weight of the patient and the severity of the condition being treated.


For prophylaxis of nausea and vomiting, as during surgery and the postoperative period, the average dose is 25 mg repeated at 4- to 6-hour intervals, as necessary.



Sedation


This product relieves apprehension and induces a quiet sleep from which the patient can be easily aroused. Administration of 12.5 to 25 mg Phenergan by the oral route or by rectal suppository at bedtime will provide sedation in children. Adults usually require 25 to 50 mg for nighttime, presurgical, or obstetrical sedation.



Pre- and Postoperative Use


Phenergan in 12.5- to 25-mg doses for children and 50-mg doses for adults the night before surgery relieves apprehension and produces a quiet sleep.


For preoperative medication, children require doses of 0.5 mg per pound of body weight in combination with an appropriately reduced dose of narcotic or barbiturate and the appropriate dose of an atropine-like drug. Usual adult dosage is 50 mg Phenergan with an appropriately reduced dose of narcotic or barbiturate and the required amount of a belladonna alkaloid.


Postoperative sedation and adjunctive use with analgesics may be obtained by the administration of 12.5 to 25 mg in children and 25- to 50-mg doses in adults.


Phenergan Tablets and Phenergan Rectal Suppositories are contraindicated for children under 2 years of age.



HOW SUPPLIED


Phenergan® (promethazine HCl) Tablets are available as follows:


12.5 mg, orange tablet with “WYETH” on one side and “19” on the scored reverse side.


NDC 0008-0019-01, bottle of 100 tablets.


25 mg, white tablet with “WYETH” and “27” on one side and scored on the reverse side.


NDC 0008-0027-02, bottle of 100 tablets.


NDC 0008-0027-07, Redipak® carton of 100 tablets (10 blister strips of 10).


50 mg, pink tablet with “WYETH” on one side and “227” on the other side.


NDC 0008-0227-01, bottle of 100 tablets.


Keep tightly closed.


Store at controlled room temperature 20º to 25ºC (68º to 77ºF).


Protect from light.


Dispense in light-resistant, tight container.


Use carton to protect contents from light.


Phenergan® (promethazine HCl) Rectal Suppositories are available in boxes of 12 as follows:


12.5 mg, ivory, torpedo-shaped suppository wrapped in copper-colored foil, NDC 0008-0498-01.


25 mg, ivory, torpedo-shaped suppository wrapped in light-green foil, NDC 0008-0212-01.


50 mg, ivory, torpedo-shaped suppository wrapped in blue foil, NDC 0008-0229-01.


Store refrigerated between 2°-8°C (36°-46°F).


Dispense in well-closed container.


Wyeth®


Wyeth Pharmaceuticals Inc.

Philadelphia, PA 19101


W10448C003

ET02

Rev 07/05








Phenergan 
promethazine hydrochloride  tablet










Product Information
Product TypeHUMAN PRESCRIPTION DRUGNDC Product Code (Source)0008-0019
Route of AdministrationORALDEA Schedule    























INGREDIENTS
Name (Active Moiety)TypeStrength
promethazine hydrochloride (promethazine)Active12.5 MILLIGRAM  In 1 TABLET
lactoseInactive 
magnesium stearateInactive 
methylcelluloseInactive 
saccharin sodiumInactive 
FD&C Yellow 6Inactive 






















Product Characteristics
ColorORANGE (ORANGE )Score2 pieces
ShapeROUND (ROUND )Size8mm
FlavorImprint Code19;Wyeth
Contains      
CoatingfalseSymbolfalse










Packaging
#NDCPackage DescriptionMultilevel Packaging
10008-0019-01100 TABLET In 1 BOTTLENone






Phenergan 
promethazine hydrochloride  tablet










Product Information
Product TypeHUMAN PRESCRIPTION DRUGNDC Product Code (Source)0008-0027
Route of AdministrationORALDEA Schedule    




















INGREDIENTS
Name (Active Moiety)TypeStrength
promethazine hydrochloride (promethazine)Active25 MILLIGRAM  In 1 TABLET
lactoseInactive 
magnesium stearateInactive 
methylcelluloseInactive 
saccharin sodiumInactive 






















Product Characteristics
ColorWHITE (WHITE )Score4 pieces
ShapeROUND (ROUND )Size8mm
FlavorImprint Code27;Wyeth
Contains      
CoatingfalseSymbolfalse














Packaging
#NDCPackage DescriptionMultilevel Packaging
10008-0027-02100 TABLET In 1 BOTTLENone
20008-0027-07100 TABLET In 1 CARTONNone






Phenergan 
promethazine hydrochloride  tablet










Product Information
Product TypeHUMAN PRESCRIPTION DRUGNDC Product Code (Source)0008-0227
Route of AdministrationORALDEA Schedule    




















INGREDIENTS
Name (Active Moiety)TypeStrength
promethazine hydrochloride (promethazine)Active50 MILLIGRAM  In 1 TABLET
lactoseInactive 
magnesium stearateInactive 
methylcelluloseInactive 
FD&C Red 40Inactive 






















Product Characteristics
ColorPINK (PINK )Scoreno score
ShapeROUND (ROUND )Size10mm
FlavorImprint Code227;Wyeth
Contains      
CoatingfalseSymbolfalse










Packaging
#NDCPackage DescriptionMultilevel Packaging
10008-0227-01100 TABLET In 1 BOTTLENone






Phenergan 
promethazine hydrochloride  suppository










Product Information
Product TypeHUMAN PRESCRIPTION DRUGNDC Product Code (Source)0008-0498
Route of AdministrationRECTALDEA Schedule    




















INGREDIENTS
Name (Active Moiety)TypeStrength
promethazine hydrochloride (promethazine)Active12.5 MILLIGRAM  In 1 SUPPOSITORY
ascorbyl palmitateInactive 
silicon dioxideInactive 
white waxInactive 
cocoa butterInactive 


















Product Characteristics
Color    Score    
ShapeSize
FlavorImprint Code
Contains      










Packaging
#NDCPackage DescriptionMultilevel Packaging
10008-0498-0112 SUPPOSITORY In 1 BOXNone






Phenergan 
promethazine hydrochloride  suppository










Product Information
Product TypeHUMAN PRESCRIPTION DRUGNDC Product Code (Source)0008-0212
Route of AdministrationRECTALDEA Schedule    




















INGREDIENTS
Name (Active Moiety)TypeStrength
promethazine hydrochloride (promethazine)Active25 MILLIGRAM  In 1 SUPPOSITORY
ascorbyl palmitateInactive 
silicon dioxideInactive 
white waxInactive 
cocoa butterInactive 


















Product Characteristics
Color    Score    
ShapeSize
FlavorImprint Code
Contains      










Packaging
#NDCPackage DescriptionMultilevel Packaging
10008-0212-0112 SUPPOSITORY In 1 BOXNone






Phenergan 
promethazine hydrochloride  suppository










Product Information
Product TypeHUMAN PRESCRIPTION DRUGNDC Product Code (Source)0008-0229
Route of AdministrationRECTALDEA Schedule    




















INGREDIENTS
Name (Active Moiety)TypeStrength
promethazine hydrochloride (promethazine)Active50 MILLIGRAM  In 1 SUPPOSITORY
ascorbyl palmitateInactive 
silicon dioxideInactive 
white waxInactive 
cocoa butterInactive 


















Product Characteristics
Color    Score    
ShapeSize
FlavorImprint Code
Contains      










Packaging
#NDCPackage DescriptionMultilevel Packaging
10008-0229-0112 SUPPOSITORY In 1 BOXNone

Revised: 05/2007Wyeth Pharmaceuticals Inc.

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Psorizide Forte





Dosage Form: tablet
PSORIZIDE® Forte

CAUTION


Federal law prohibits dispensing without a prescription.



Psorizide Forte Description


PSORIZIDE® Forte is a biochemical homeopathic medication indicated for the treatment of contact dermatitis due to nickel (metal/jewelry allergy), dyshidrotic hand/foot eczema, and mild to severe psoriasis.1-3 The active ingredients in each PSORIZIDE® Forte tablet consist of the following: Fumaric Acid (Fumaricum Acidum) 1X, Potassium Bromide (Kali Bromatum) 1X, and Nickel Sulphate (Niccolum Sulphuricum) 1X. These drug ingredients are listed in the Homoeopathic Pharmacopoeia of the United States (HPUS).4


Inactive ingredients: Lactose and Magnesium Stearate.


Pharmacological Class: Homeopathic drug.


Dosage form: Oral 600 mg scored tablet. May be swallowed whole, chewed or dissolved in the mouth and swallowed.



Psorizide Forte - Clinical Pharmacology


The active ingredients in PSORIZIDE® Forte are simple biochemical compounds. The exact mechanism of action is unknown; however, it is believed PSORIZIDE® Forte addresses a primary genetic biochemical defect.5


FUMARIC ACID is a naturally occurring four carbon organic acid important in the Krebs cycle. This biochemical pathway is of central importance to energy production. Each tablet contains approximately 30 mg fumaric acid (calculated). Fumaric Acid has many uses, including use as a food additive (GRAS) and as a chelating agent.13 The use of fumaric acid and its derivatives (esters) as a treatment for psoriasis is increasing worldwide.14-20 Very little is known about its clinical pharmacology; however, dose dependant inhibitory effects on keratinocyte proliferation have been demonstrated. 16,21


POTASSIUM BROMIDE dissolves and dissociates in the digestive tract into its ionic constituents. Each tablet contains approximately 15 mg bromide (calculated). Ionic bromide is rapidly and completely absorbed from the intestine and distributed almost exclusively into the extracellular fluids.11,12 Bromide is eliminated by the kidneys and the elimination half-life is 11-12 days. "Once a day" dosing will lead to a steady state concentration in about seven weeks.11


NICKEL SULPHATE dissolves and dissociates in the digestive tract into its ionic constituents. Each tablet contains approximately 1.0 mg of ionic nickel (calculated). According to studies, 15% to 50% of ionic nickel is absorbed on a fasted stomach.6 Food markedly decreases the rate and extent of nickel absorption.7,8 Clinical studies show that serum concentrations of nickel are variable among patients after administering the same dose.9 Peak serum nickel concentration is reached about two hours after oral administration. "Once a day" dosing leads to steady state serum concentrations in approximately one week. Nickel is in its highly stable divalent cation state and is therefore not expected to be metabolized to any significant degree in the body. Absorbed nickel is primarily excreted in the urine and elimination half-life is about 21 hours.7,9 Renal clearance is rapid and efficient, and nickel does not accumulate in the body.10



Clinical Studies


A variety of controlled clinical studies have been performed using various sources of both nickel and bromide in over 300 subjects. Clinical efficacy and safety have been documented in a significant number of subjects. Published and unpublished reports are available upon request.22,23,32



INDICATIONS


PSORIZIDE® Forte is indicated for the treatment of contact dermatitis due to nickel (metal/jewelry allergy,) dyshidrotic hand/foot eczema, and mild to severe psoriasis. It has been found to work well with a variety of combination therapies. Eczema, seborrhea and a variety of chronic pruritic inflammatory dermatoses generally respond well also.



Contraindications


Although there are no known contraindications, patients who are allergic to any PSORIZIDE® Forte ingredient should consult a physician prior to taking the medication. (Refer to Section on Hypersensitivity)



Warning


Do not use if imprinted seal under bottle cap is missing or broken. Do not use if pregnant or nursing. If allergic to nickel or metal objects such as jewelry, see PRECAUTIONS for hypersensitivity information. Lactose intolerant patients may have gastrointestinal difficulty. This has very rarely been reported at the doses used.



Precautions


Carefully adjust dosage to weight when treating young children. Use cautiously in setting of kidney disease. (see Dosage and Administration) If skin rash appears or if nervous symptoms persist, recur frequently, or are unusual, discontinue use.



Hypersensitivity


Caution should be used when administering to patients with a history of contact sensitivity to nickel (common metal exposure). Nickel allergy may be confirmed by a positive nickel patch test. Most patients with positive nickel allergy history or a positive nickel patch test do not have any untoward reaction to administration of PSORIZIDE® Forte. However, if there is a history of nickel sensitivity, begin with a very low dose and slowly increase over a period of six weeks as tolerated. Progressive G.I. absorption allows desensitization to occur.8

















Nickel desensitization schedule:
WeekAmount of Time to Take Medication Prior to Breakfast
Week 11 tablet With Breakfast
Week 21 tablet 15 min Prior
Week 31 tablet 30 min Prior
Week 41 tablet 45 min Prior
Week 51 tablet 1 hour Prior
Week 6 and thereon2 tablets 1 hour Prior

If new pruritic rashes occur or persist, discontinue PSORIZIDE® Forte and treat appropriately. Do not use if there is a history of extra-cutaneous hypersensitivity to nickel or any ingredient in PSORIZIDE® Forte.



Information for patients


Patients using PSORIZIDE® Forte should receive the following information and instructions:


  1. This medication is to be used only as directed by a physician.

  2. It is important to take orally at the beginning of the day on an empty stomach (or any convenient time after having taken nothing but water for at least 7 hours) and to eat or drink nothing but water for one hour afterwards to avoid interference with absorption.


Drug Interactions


There are no known drug interactions.



Carcinogenesis, mutagenesis, and impairment of fertility


No studies have been done on the carcinogenesis, mutagenesis, or impairment of fertility of PSORIZIDE® Forte. No carcinogenesis or mutagenesis has been reported in multiple animal studies for oral administration of fumaric acid and soluble nickel and bromide salts (active ingredients) even at very high doses.24-27



Effects of fumaric acid


It is not listed as a carcinogen by ACGIH, IARC, NIOSH, NTP, or OSHA.26 It is a GRAS substance (generally recognized as safe) and is commonly used in food processing.



Effects of soluble potassium bromide


KBr is not listed as a carcinogen by the NTP, IARC, and OSHA.28



Effects of soluble nickel sulphate


Studies on experimental animals have never indicated that nickel, at any dose, is a carcinogen when introduced to the body orally. Furthermore, Nickel sulphate and other highly water soluble nickel salts, have never been known to induce carcinogenesis via any route of introduction including: oral, inhalation, cutaneous, IM, or IP.10-12,27 No adverse effects were noted on fertility or reproduction in a 3-generational study of albino Wistar rats fed up to 1000 ppm Ni per day, which is equivalent to 50 mg/kg body weight per day Ni.27



Pregnancy


Pregnancy category C

Animal reproduction studies have not been conducted with PSORIZIDE® Forte. PSORIZIDE® Forte should not be given to a pregnant woman.



Nursing mothers


It is not known whether this drug is secreted in human milk. However, since many drugs are secreted in human milk, caution should be exercised when PSORIZIDE® Forte is administered to a nursing woman.



Pediatric use


Carefully adjust dosage to weight when treating young children.



Adverse Reactions


PSORIZIDE® Forte contains low doses of active ingredients. Therefore there are minimal known side effects.


(see PRECAUTIONS for hypersensitivity information)



Overdosage



Fumaric acid toxicity


The oral rat LD50 is 9300mg/kg.26 This is 3800 times the maximum dose recommended for PSORIZIDE® Forte.



Potassium bromide toxicity


Indications of toxicity due to oral overdosage of bromide may include nausea and vomiting, apathy, disturbed coordination, loss of memory, drowsiness, loss of emotional control, agitation, hallucination, tremors, depressed reflexes, stupor, and coma. Acute toxic reactions in humans have been reported at doses as low as 1000mg.31 This level is 67 times the dose received in one tablet of PSORIZIDE® Forte.



Nickel sulphate toxicity


The oral rat LD50 for nickel sulphate hexahydrate is 275mg/kg.29 Symptoms of toxicity due to oral overdosage of nickel sulphate may include nausea, vomiting, abdominal discomfort, diarrhea, giddiness, lassitude, headaches, cough, and shortness of breath.30 The lowest observed transitory toxic effects from human ingestion of soluble nickel salts is approximately 8 mg nickel/kg body weight.30 This is 138 times the maximum dose recommended for PSORIZIDE® Forte (see below).



Psorizide Forte Dosage and Administration


Absorption of nickel sulphate is variable among individuals. For maximum absorption, tablets should be taken orally at the beginning of the day (or any convenient time after having taken nothing but water for at least 7 hours). Take nothing but water for one hour after taking medication to aid absorption.























WeightStarting DoseMax Daily Dose
    40-80 lbs  ½ tablet1 ½ tablet  
  80-120 lbs   1 tablet    3 tablets
120-160 lbs1 ½ tablets4 ½ tablets
160-200 lbs    2 tablets    6 tablets
200-240 lbs2 ½ tablets7 ½ tablets
Over 240 lbs    3 tablets    9 tablets

In the setting of renal impairment


Dosage should be adjusted and serum nickel and bromide levels should be followed. Steady state trough level should be drawn prior to ingesting the day's dose after one week of dosing or at appropriate intervals. Target trough serum nickel level is 30-60 mcg/L. (Caution: post dose peak levels are unreliable.)



Maintenance phase


In order to maintain symptomatic relief, medication may be continued at the same or reduced initial phase dose level. Treatment duration depends on the individual. For allergic nickel dermatitis, continue 2 tablets 1 hour prior to breakfast for weeks 7 – 16. (Refer to Hypersensitivity section above). Some patients may require continued or intermittent repeated treatment to maintain nickel desensitization.



INACTIVE INGREDIENTS


Lactose and magnesium stearate.



How is Psorizide Forte Supplied


Scored tablets, off white in color with green speckles, with



REFERENCES


  1. Reckeweg, Hans-Heinrich, Materia Medica, 1983, first English edition.

  2. Boericke, William, Materia Medica with Reperatory, 1927, ninth edition.

  3. Clarke, John Henry, A Dictionary of Practical Materia Medica, 1921, reprint edition 1996.

  4. The Homeopathic Pharmacopoeia of the United States (HPUS), December 2000 edition, Falls Church, Virginia.

  5. Kiehl R, Ionescu G, A Defective Purine Nucleotide Synthesis Pathway in Psoriatic Patients, Acta Derm Venereol (stockh), 1992, 72:253-255.

  6. Sunderman FW Jr. Biological monitoring of nickel in humans. Scand J. Work Environ Health 1993; 19 suppl 1:34-38.

  7. Sunderman FW Jr., Hopfer SM, Sweeney KR, Marcus AH, Most BM, Creason J. Ncikel absorption and kinetics in human volunteers. P.S.E.B.M. 1989; 191:5-11.

  8. Solomons NW, Viteri F, Shuler TR, Nielsen FH, Bioavailability of nickel in man: Effects of foods and chemically-defined dietary constituents on the absorption of inorganic nickel. J Nutr 1982; 112:39-50.

  9. Christensen OB, Lagesson V. Nickel concentration of blood and urine after oral administration. Annals of Clinical and Laboratory Science 1981;2(2);119-125.

  10. Nielsen FH. Is nickel nutritionally important? Nutrition Today 1993; 28 (1):14-19.

  11. Vaiseman N. Koren G. Pencharz P. Pharmacokinetics of oral and intravenous bromide in normal volunteers. Clinical Toxicology 1986;24(5):403-413.

  12. Van Leeuwen FXR, Sangster B. The toxicology of bromide ion. CRC Critical Reviews in Toxicology 1987; 18(3): 189-213.

  13. Wade A, Weller PJ Handbook of Pharmaceutical Excipients 2nd edition, American Pharmaceutical Association, 1994.

  14. Parfitts K, editor, Martindale: The complete Drug Reference, 1999, 32nd edition, Pharmaceutical Press, London.

  15. Nieboer C, et al, Fumaric Acid Therapy in Psoriasis, Dermatologica, 1990; 181:33-37

  16. Mrowietz U, et al, Treatment of severe psoriasis with fumaric acid esters: scientific background and guidelines for therapeutic use, Br J Dermatol 1999;141:424-429.

  17. Mrowietz U, et al, Treatment of psoriasis with fumaric acid esters, Br J Dermatol 1998; 138:456-460.

  18. Kolbach DN, Nieboer C, Fumaric Acid Therapy in Psoriasis, J Am Acad Dermatol 1992; 27: 769-771.

  19. Altmeyer P, et al, Antipsoriatic Effect of Fumaric Acid Derivatives, J Am Acad Dermatol 1994; 30:997-981.

  20. Nugteren – Huying WM, etal, Fumaric Acid Therapy for Psoriasis, J Am Acad Dermatol 1990; 22: 311-312.

  21. Thio, HB, et al, Fumaric Acid Derivatives… Inhibit the proliferation of Human Keratinocytes, Br J Dermatol 1994; 131: 856-866.

  22. Smith SA. Oral supplementation of nickel and bromide in psoriasis vulgaris using nickel sulfate and sodium bromide. 1995 (unpublished report).

  23. Smith SA, et al, Improvement of Psoriasis Vulgaris with Oral Nickel Dibromide. Archives of Dermatology 1997; 133:661-663.

  24. US EPA, Environmental Criteria and Assessment Office, Office of Health and Environmental Assessment. Drinking water quantification of toxicological effects for nickel. ECAO-CIN-443. US FDA, Center for Food Safety and Applied Nutrition. Guidance document for nickel in shellfish. 1993.

  25. IARC Monograph on the Evaluation of Carcinogenic Risk of Chemicals to Man. IRC Publication #11, Lyon, France 1976.

  26. MSDS Fumaric Acid. Acros Organics, Fair Lawn, N.J., Revised 8/2000.

  27. Ambrose AM, Larson PS, Borsellaca FJ, and Hennigar GR, JR. Long term toxicologic assessment of nickel in rats and dogs. Journal of Food and Science and Technology 1976;13:181-187.

  28. MSDS Sheet No. 247 Potassium Bromide, Schenectady, NY: Genium Publishing Corp 1991.

  29. MSDS Sheet No. 37 Nickel Sulfate, Schenectady, NY: Genium Publishing Corp 1993.

  30. Sunderman FW Jr., Dingle B, Hopfer SM, and Swift T. Acute nickel toxicity in electroplating workers who accidentally ingested a solution of nickel sulfate and nickel chloride. American Journal of Industrial Medicine 1988; 14:257-266.

  31. Martindale: The Extra Pharmacopoeia, 27th ed. Wade A, editor. The Pharmaceutical Press: London, 1977, pp 273-274.

  32. Smith SA, Baker AE, etal. Effective Treatment of Seborrheic Dermatitis Using a Low Dose, Oral Homeopathic Medication… Alt Med Rev 2002; 7, pp59-67, 1991.


RxSales@PlymouthPharmaceuticals.com


www.PlymouthPharmaceuticals.com


Plymouth Pharmaceuticals Inc. dba LOMA LUX Laboratories; P.O. BOX 702418; Tulsa, OK 74170-2418


Phone 800.316.9636, 918.664.9882, Fax 918.664.9884


Revised 1.10.07 TS



PRINCIPAL DISPLAY PANEL - 90 Tablet Label


NDC 61480-255-05

Homeopathic Medication


PSORIZIDE® Forte


Indicated for treatment of

PSORIASIS


90 Tablets










Psorizide Forte 
nickel sulfate, potassium bromide, and fumaric acid  tablet










Product Information
Product TypeHUMAN PRESCRIPTION DRUGNDC Product Code (Source)61480-255
Route of AdministrationORALDEA Schedule    














Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Nickel Sulfate (Nickel)Nickel Sulfate1 [hp_X]
Potassium Bromide (Bromine)Potassium Bromide1 [hp_X]
Fumaric Acid (Fumaric Acid)Fumaric Acid1 [hp_X]





Inactive Ingredients
Ingredient NameStrength
No Inactive Ingredients Found


















Product Characteristics
ColorWHITE (Off-White with Green Speckles)Score2 pieces
ShapeROUNDSize11mm
FlavorImprint CodeLL
Contains      










Packaging
#NDCPackage DescriptionMultilevel Packaging
161480-255-0590 TABLET In 1 BOTTLENone










Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
Unapproved homeopathic11/15/2001


Labeler - Plymouth Pharmaceuticals Inc (879368124)









Establishment
NameAddressID/FEIOperations
Heel, Inc.102783016Manufacture
Revised: 08/2010Plymouth Pharmaceuticals Inc