Thursday, September 29, 2016

Badyket




Badyket may be available in the countries listed below.


Ingredient matches for Badyket



Bemiparin Sodium

Bemiparin Sodium is reported as an ingredient of Badyket in the following countries:


  • Argentina

  • Costa Rica

  • Dominican Republic

  • El Salvador

  • Guatemala

  • Honduras

  • Nicaragua

  • Panama

International Drug Name Search

Diclonatrium




Diclonatrium may be available in the countries listed below.


Ingredient matches for Diclonatrium



Diclofenac

Diclofenac sodium salt (a derivative of Diclofenac) is reported as an ingredient of Diclonatrium in the following countries:


  • Brazil

International Drug Name Search

Inotrin




Inotrin may be available in the countries listed below.


Ingredient matches for Inotrin



Isotretinoin

Isotretinoin is reported as an ingredient of Inotrin in the following countries:


  • Greece

International Drug Name Search

Tanlozid




Tanlozid may be available in the countries listed below.


Ingredient matches for Tanlozid



Hydrochlorothiazide

Hydrochlorothiazide is reported as an ingredient of Tanlozid in the following countries:


  • Sweden

Losartan

Losartan potassium salt (a derivative of Losartan) is reported as an ingredient of Tanlozid in the following countries:


  • Sweden

International Drug Name Search

Wednesday, September 28, 2016

Glemid




Glemid may be available in the countries listed below.


Ingredient matches for Glemid



Glimepiride

Glimepiride is reported as an ingredient of Glemid in the following countries:


  • Czech Republic

  • Poland

  • Slovakia

International Drug Name Search

Dompéridone Mylan




Dompéridone Mylan may be available in the countries listed below.


Ingredient matches for Dompéridone Mylan



Domperidone

Domperidone is reported as an ingredient of Dompéridone Mylan in the following countries:


  • France

International Drug Name Search

Tetracosactide Acetate




Tetracosactide Acetate may be available in the countries listed below.


Ingredient matches for Tetracosactide Acetate



Tetracosactide

Tetracosactide Acetate (BANM) is also known as Tetracosactide (Rec.INN)

International Drug Name Search

Glossary

BANMBritish Approved Name (Modified)
Rec.INNRecommended International Nonproprietary Name (World Health Organization)

Click for further information on drug naming conventions and International Nonproprietary Names.

liothyronine


Generic Name: liothyronine (LYE oh THYE roe neen)

Brand names: Cytomel, Triostat


What is liothyronine?

Liothyronine is a man-made form of a hormone that is normally produced by your thyroid gland to regulate the body's energy and metabolism. Liothyronine is given when the thyroid does not produce enough of this hormone on its own.


Liothyronine treats hypothyroidism (low thyroid hormone). Liothyronine is also used to treat or prevent goiter (enlarged thyroid gland), and is also given as part of a medical tests for thyroid disorders.


Liothyronine should not be used to treat obesity or weight problems.


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


What is the most important information I should know about liothyronine?


Since thyroid hormone occurs naturally in the body, almost anyone can take liothyronine. However, you may not be able to use this medication if you have a thyroid disorder called thyrotoxicosis, or an adrenal gland problem that is not controlled by treatment.

Before taking liothyronine, tell your doctor if you have heart disease, angina (chest pain), coronary artery disease, congestive heart failure, diabetes, or problems with your pituitary or adrenal glands.


Tell your doctor if you are pregnant or breast-feeding.

To be sure this medication is helping your condition, your blood may need to be tested often. Visit your doctor regularly.


Keep using this medicine as directed, even if you feel well. You may need to take thyroid medication for the rest of your life.


Call your doctor if you notice any signs of thyroid toxicity, such as chest pain, fast or pounding heartbeats, feeling hot or nervous, or sweating more than usual.

What should I discuss with my healthcare provider before taking liothyronine?


Since thyroid hormone occurs naturally in the body, almost anyone can take liothyronine. However, you may not be able to use this medication if you have a thyroid disorder called thyrotoxicosis, or an adrenal gland problem that is not controlled by treatment.

To make sure you can safely take liothyronine, tell your doctor if you have any of these other conditions:



  • heart disease, angina (chest pain);




  • coronary artery disease;




  • congestive heart failure;




  • any type of diabetes; or




  • problems with your pituitary or adrenal gland.




FDA pregnancy category A. Liothyronine is not expected to harm an unborn baby. However, tell your doctor if you become pregnant, since your dose needs may be different during pregnancy. Small amounts of liothyronine can pass into breast milk, but this is not expected to harm a nursing baby. However, do not use this medication without telling your doctor if you are breast-feeding a baby.

How should I take liothyronine?


Take exactly as prescribed by your doctor. Do not take in larger or smaller amounts or for longer than recommended. Follow the directions on your prescription label.


Liothyronine is usually taken once daily. Follow your doctor's instructions.


Your doctor may occasionally change your dose to make sure you get the best results.


If you are switching to liothyronine from any other thyroid medication, stop using the other medication before you start taking liothyronine.


To be sure this medication is helping your condition, your blood may need to be tested often. Visit your doctor regularly.


Keep using this medicine as directed, even if you feel well. You may need to take thyroid medication for the rest of your life.


Call your doctor if you notice any signs of thyroid toxicity, such as chest pain, fast or pounding heartbeats, feeling hot or nervous, or sweating more than usual. If you need surgery, tell the surgeon ahead of time that you are using liothyronine. You may need to stop using the medicine for a short time. Store at room temperature away from moisture and heat.

See also: Liothyronine dosage (in more detail)

What happens if I miss a dose?


Take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.


What happens if I overdose?


Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Overdose symptoms may include headache, sweating, diarrhea, irregular menstrual periods, confusion, weakness, swelling in your hands or feet, fast heart rate, chest pain, feeling short of breath, fainting, or feeling nervous, restless, or irritable.


What should I avoid while taking liothyronine?


Do not change brands or change to a generic product without first asking your doctor. Different brands of liothyronine may not work the same. If you get a prescription refill and your new pills look different, talk with your pharmacist or doctor.

If you also take cholestyramine (Prevalite, Questran) or colestipol (Colestid), avoid taking these medications within 4 hours before or after you take liothyronine.


Liothyronine side effects


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

Less serious side effects may include temporary hair loss (especially in children).


This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.


Liothyronine Dosing Information


Usual Adult Dose for Hypothyroidism:

Initial dose: 25 mcg orally once a day; may be increased by up to 25 mcg every 1 to 2 weeks depending on the patient's clinical response and laboratory findings

Maintenance dose: 25 to 75 mcg daily

Usual Adult Dose for Myxedema:

Initial dose: 5 mcg orally once a day; may be increased by 5 to 10 mcg every 1 to 2 weeks depending on the patient's clinical response and laboratory findings

When treatment is up to 25 mcg/day, the dosage may be increased by 5 to 25 mcg every week or two until a satisfactory therapeutic response is attained.

Maintenance dose: 50 to 100 mcg daily

Usual Adult Dose for Myxedema Coma:

25 to 50 mcg intravenously

If the patient has known or suspected cardiovascular disease, then an initial dose of 10 to 20 mcg in conjunction with cardiac monitoring is recommended.

Subsequent doses should be determined by the patient's clinical condition and response to treatment. Generally, doses should be administered at least 4 hours and no more than 12 hours apart. Caution is advised in adjusting the dose due to the potential of acute and large changes to precipitate adverse cardiovascular events.

Available clinical data indicate reduced mortality in patients receiving at least 65 mcg/day in the initial days of treatment. However, there is limited clinical experience with dosages above 100 mcg/day.

Oral thyroid hormone therapy should be substituted as soon as the patient is stable and able to take oral medication. If levothyroxine rather than liothyronine is used, the prescriber should bear in mind that there is a delay of several days in the onset of levothyroxine activity and that intravenous therapy should be discontinued gradually.

Usual Adult Dose for Thyroid Suppression Test:

75 to 100 mcg orally once a day for 7 days

Radioactive (131) iodine uptake should be determined before and after the administration of thyroid hormone. If thyroid function is under normal control, the radioactive iodine uptake should drop significantly after treatment. A 50% or greater suppression of uptake indicates a normal thyroid-pituitary axis and rules out thyroid gland autonomy.

Liothyronine should be administered cautiously if there is a strong suspicion of thyroid gland autonomy, as exogenous hormone effects will be additive to those of the endogenous source.

Usual Adult Dose for TSH Suppression:

Initial dose: 5 mcg orally once a day; may be increased by 5 to 10 mcg every 1 to 2 weeks depending on the patient's clinical response and laboratory findings

When treatment is up to 25 mcg/day, the dosage may be increased by 12.5 to 25 mcg every week or two until a satisfactory therapeutic response is attained.

Maintenance dose: 75 mcg daily

Usual Pediatric Dose for Hypothyroidism:

Congenital hypothyroidism/Hypothyroidism:
Infants and Children less than or equal to 3 years:
Initial dose: 5 mcg orally once a day; may be increased by 5 mcg every 3 days to a maximum dosage of 20 mcg/day for infants and 50 mcg/day for children 1 to 3 years of age.

Hypothyroidism:
Initial dose: Children: 5 mcg orally once a day. Increase in 5 mcg/day increments every 3 to 4 days
Usual maintenance dose:
Infants: 20 mcg orally once a day
Children 1 to 3 years: 50 mcg orally once a day
Children greater than 3 years: Full adult dosage may be necessary

Goiter (nontoxic):
Children:
Initial dose: 5 mcg orally once a day. Increase in 5 mcg/day increments every 1 to 2 weeks
Maintenance dose: 15 to 20 mcg orally once a day

Goiter (nontoxic):
Children: 5 mcg orally once a day. Increase in 5 mcg/day increments every 1 to 2 weeks
Maintenance dose 15 to 20 mcg orally once a day


What other drugs will affect liothyronine?


Tell your doctor about all other medicines you use, especially:



  • birth control pills or hormone replacement therapy;




  • a blood thinner such as warfarin (Coumadin);




  • digoxin (digitalis, Lanoxin);




  • epinephrine (EpiPen) or norepinephrine (Levophed);




  • insulin or oral diabetes medication;




  • medications that contain iodine (such as I-131);




  • an antidepressant such as amitriptyline (Elavil, Vanatrip), doxepin (Sinequan), desipramine (Norpramin), imipramine (Janimine, Tofranil), nortriptyline (Pamelor), and others;




  • salicylates such as aspirin, Backache Relief Extra Strength, Novasal, Nuprin Backache Caplet, Doan's Pills Extra Strength, Pepto-Bismol, Tricosal, and others;




  • steroids such as prednisone and others.



This list is not complete and other drugs may interact with liothyronine. Tell your doctor about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal products. Do not start a new medication without telling your doctor.



More liothyronine resources


  • Liothyronine Side Effects (in more detail)
  • Liothyronine Dosage
  • Liothyronine Use in Pregnancy & Breastfeeding
  • Drug Images
  • Liothyronine Drug Interactions
  • Liothyronine Support Group
  • 7 Reviews for Liothyronine - Add your own review/rating


  • liothyronine Advanced Consumer (Micromedex) - Includes Dosage Information

  • Liothyronine Prescribing Information (FDA)

  • Liothyronine MedFacts Consumer Leaflet (Wolters Kluwer)

  • Cytomel Prescribing Information (FDA)

  • Cytomel MedFacts Consumer Leaflet (Wolters Kluwer)

  • Liothyronine Sodium Monograph (AHFS DI)

  • Triostat Prescribing Information (FDA)

  • Triostat Advanced Consumer (Micromedex) - Includes Dosage Information



Compare liothyronine with other medications


  • Hypothyroidism, After Thyroid Removal
  • Myxedema
  • Myxedema Coma
  • Thyroid Suppression Test
  • TSH Suppression
  • Underactive Thyroid


Where can I get more information?


  • Your pharmacist can provide more information about liothyronine.

See also: liothyronine side effects (in more detail)


Dicofan




Dicofan may be available in the countries listed below.


Ingredient matches for Dicofan



Sodium Phosphate (32P)

Sodium Phosphate (32P) is reported as an ingredient of Dicofan in the following countries:


  • Argentina

International Drug Name Search

Tuesday, September 27, 2016

Vomisin




Vomisin may be available in the countries listed below.


Ingredient matches for Vomisin



Dimenhydrinate

Dimenhydrinate is reported as an ingredient of Vomisin in the following countries:


  • Mexico

International Drug Name Search

Alerviden




Alerviden may be available in the countries listed below.


Ingredient matches for Alerviden



Cetirizine

Cetirizine dihydrochloride (a derivative of Cetirizine) is reported as an ingredient of Alerviden in the following countries:


  • Colombia

International Drug Name Search

Diabamyl




Diabamyl may be available in the countries listed below.


Ingredient matches for Diabamyl



Metformin

Metformin hydrochloride (a derivative of Metformin) is reported as an ingredient of Diabamyl in the following countries:


  • France

International Drug Name Search

Dimethisoquin




Dimethisoquin may be available in the countries listed below.


Ingredient matches for Dimethisoquin



Quinisocaine

Dimethisoquin (BAN) is also known as Quinisocaine (Rec.INN)

International Drug Name Search

Glossary

BANBritish Approved Name
Rec.INNRecommended International Nonproprietary Name (World Health Organization)

Click for further information on drug naming conventions and International Nonproprietary Names.

Monday, September 26, 2016

Animal Allergens Injection




INSTRUCTIONS ALLERGENIC EXTRACTS FOR INTRADERMAL TESTING
Warnings

This product is intended for use only by physicians who are experienced in the use of allergenic extracts, or for use under the guidance of an allergist.


Allergenic extracts may potentially elicit a severe life-threatening systemic reaction, rarely resulting in death.7 Therefore, emergency measures and personnel trained in their use should be available immediately in the event of such a reaction. Patients should be instructed to recognize adverse reaction symptoms and cautioned to contact the physician's office if symptoms occur.


Scratch, prick or puncture test first. Test intradermally only to those antigens giving negative or questionable reactions on scratch, prick or puncture testing.


This product should never be injected intravenously.


Patients on non-selective beta blockers may be more reactive to allergens given for testing or treatment and may be unresponsive to the usual doses of epinephrine used to treat allergic reactions.6


Refer also to the WARNINGS, PRECAUTIONS, and ADVERSE REACTIONS Sections below for further discussion.




Animal Allergens Injection Description


Extracts for intradermal testing are supplied in sterile multi-dose vials containing, in addition to the extract allergens and antigens, 0.5% sodium chloride, 0.275% sodium bicarbonate, up to 2% glycerin, 2.5% glycerin for AP™ products; and, as preservative, 0.4% phenol. The strength of these extracts may be expressed in terms of

1. Weight to Volume (w/v)

2. Protein Nitrogen Units/mL (PNU/mL)

3. Allergy Units/mL (AU/mL)

4. Bioequivalent Allergy Units/mL (BAU/mL)

5. Concentrate
  1. Weight to volume (w/v). For regular extracts this describes the extraction ratio, i.e., the amount of crude allergen added to the extracting fluid. A 1:10 extract, therefore, indicates that the solution contains the extracted material from one gram of raw material added to each 10 mL of extracting fluid. The amount and composition of extracted material will vary with the kind of antigen, the extracting fluid, duration of extraction, pH, temperature, and other variables. In contrast to this, APTM (acetone precipitated) extracts, if present, are prepared by reconstituting dry allergenically active concentrates produced by a precipitation process from extracts of raw materials. For those AP™ extracts labeled on a weight per volume (w/v) basis, the strength designation indicates the dry weight of finished (acetone) precipitate per volume of reconstituting fluid. For example, 1:50 (w/v) means that each gram of dry precipitate obtained from the original extract is reconstituted in 50 mL of solution.

  2. Protein Nitrogen Units per mL (PNU/mL). One protein nitrogen unit represents 0.00001 mg phosphotungstic acid-precipitable protein nitrogen dissolved in one mL of antigen extract. The PNU content of extracts of the same antigen may vary according to the method of measuring the PNU. Thus, PNU contents of extracts from different manufacturers are not comparable unless the PNU method is known to be the same and reproducible from lot to lot. Also, the amount of protein nitrogen extracted from an antigen is influenced by the same variables as the weight to volume extract. Allergenic materials make up a variable proportion of the total protein of an extract.

  3. Allergy Units per mL (AU/mL). The potency of standardized APTM and regular extracts labeled in Allergy Units (AU)/mL is determined by in vitro comparison to the reference standard established by the Center for Biologics Evaluation and Research (CBER) of the Food and Drug Administration.

  4. Bioequivalent Allergy Units per mL(BAU/mL). When originally licensed, the Reference Preparations for standardized extracts were arbitrarily assigned 100,000 Allergy Units (AU)/mL. Subsequently, quantitative skin testing by the ID50EAL method14 was used to determine that some Reference Preparations should be assigned 10,000 AU/mL, and others 100,000 AU/mL. To avoid possible confusion about this change in the method of allergy unit assignment, the nomenclature changed for standardized extracts whose allergy units are assigned based on quantitative skin testing, and are labeled in Bioequivalent Allergy Units (BAU)/mL. References labeled 10,000 BAU/mL can be diluted one to a half million fold, and references labeled 100,000 BAU/mL can be diluted one to 5 million fold and produce a sum of erythema diameter of 50 mm when Intradermal testing highly reactive subjects.

  5. Concentrate. Concentrate label terminology applies to allergenic extract mixtures, where the individual allergens being combined vary in strength or the designation of strength.


Animal Allergens Injection - Clinical Pharmacology


Allergenic extracts for intradermal testing used according to the DOSAGE AND ADMINISTRATION Section, produce erythema or erythema and wheal reactions in patients with significant IgE-mediated sensitivity to the relevant allergen. This allergic inflammatory response, although not completely understood, is thought to begin with the reaction of antigen with IgE on the surface of basophils, or mast cells, which initiates a series of biochemical events resulting in the production of histamine, slow-reacting substance of anaphylaxis and other mediators. These, in turn, produce the immediate-type wheal and flare skin reaction.



Indications and Usage for Animal Allergens Injection


Certain diagnostics carry labeling which states Allergenic Extract for Diagnostic Use Only. Data to support the therapeutic use of products labeled with this statement have not been established.15


In addition to a carefully taken history, the use of intradermal testing extracts is an accepted method in the diagnosis of allergenic conditions.1, 2, 3 When scratch, prick or puncture reactions are small, or if the patient gives a history of allergic symptoms to a substance but scratch, prick or puncture tests are inconclusive, intradermal tests may be indicated. However, ANTIGENS PRODUCING LARGE 3 TO 4+ SCRATCH, PRICK OR PUNCTURE TESTS SHOULD NOT BE TESTED INTRADERMALLY.


Extracts of all allergens do not produce equivalent results in intradermal testing. The intensity of the skin reaction produced will be determined by two factors: the degree of sensitivity of the patient and the nature of the antigenic extract applied. In general, pollen extracts produce whealing reactions, whereas other inhalants produce erythematous reactions with wheals less often. Skin tests to foods seldom produce whealing reactions except for infrequent instances of severe sensitivity to fish, nuts or spices, and rarely other foods.



Contraindications


There are no known absolute contraindications to allergy skin testing. Patients with cardiovascular diseases or pulmonary diseases such as symptomatic asthma, and/or who are receiving cardiovascular drugs such as beta blockers, may be at higher risk for severe adverse reactions. These patients may also be more refractory to the normal anaphylaxis treatment regime.



Warnings


Scratch, prick or puncture test first. Test intradermally only to those antigens giving negative or questionable reactions on scratch, prick or puncture testing. Excessively large local reactions or systemic reactions are more likely to occur if the patient is skin tested shortly after exposure to large amounts of antigen to which he or she is sensitive. Therefore, use caution when applying pollen tests to patients during their active pollen season, or after an exposure to inhalant allergens that produce symptoms. Refer to boxed WARNINGS Section.



Precautions



1. General




It is recommended that disposable syringes and needles are used for intradermal tests to prevent the possibility of accidental transfer of serum hepatitis and other infectious agents from one person to another. Always have injectable epinephrine and a tourniquet available when tests are being made. (See ADVERSE REACTION Section.) Patients should be observed in the office for 30 to 45 minutes after each set of intradermal tests and instructed to return to the office promptly if symptoms of an allergic reaction or shock occur. In order to avoid darkening and possible precipitation, do not dilute the following extracts with solutions containing phenol: Privet pollen and food extracts of White Potato, Corn, Oat, Rye, and Wheat. Injections of such extracts discolored by reaction with phenol may produce lasting tattoo-like discoloration of the skin.

2. Information for Patients


Patients should be instructed in the recognition of adverse reactions to diagnostic testing. Patients should be made to understand the importance of a 30 to 45 minute observation period and be warned to return to the office promptly if symptoms occur after leaving.



3. Carcinogenesis, Mutagensis, Impairment of Fertility


Long-term studies in animals have not been conducted with allergenic extracts to determine their potential for carcinogenicity, mutagenicity or impairment of fertility.



4. Pregnancy


4,5 Pregnancy Category C. Animal reproduction studies have not been conducted with allergenic extracts. It is also not known whether allergenic extracts can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Allergenic extracts should be given to a pregnant woman only if clearly needed.



5. Nursing Mothers


There are no current studies on secretion of the allergenic extract components in human milk or effect on the nursing infant. Because many drugs are excreted in human milk, caution should be exercised when allergenic extracts are administered to a nursing woman.



6. Drug Interactions


Patients on non-selective beta blockers may be more reactive to allergens given for testing or treatment and may be unresponsive to the usual doses of epinephrine used to treat allergic reactions.6

Certain medications may lessen the skin test wheal and erythema responses elicited by allergens and histamine for varying time periods. Conventional antihistamines should be discontinued at least 5 days before skin testing. Long acting antihistamines should be discontinued for at least 3 weeks prior to skin testing.10Topical steroids should be discontinued at the skin test site for at least 2-3 weeks before skin testing. 10, 11 Tricyclic antidepressants such as Doxepin should be withheld for at least 7 days before skin testing.12Topical local anesthetics may suppress the flare responses and should be avoided in skin test sites. 13



7. Geriatric Use


Skin test wheal size decreases with age. The decrease in allergeninduced skin test reaction parallels that to histamine; therefore, appropriate positive skin test controls should always be performed.1



8. Pediatric Use


Wheal sizes in response to allergen skin testing can be smaller in infants than in adults. The skin response to histamine parallels that for allergens; therefore, appropriate postitive control skin tests should always be performed.1



Adverse Reactions


1. Local Reactions

Large, persistent local reactions or minor exacerbations of the patient's allergic symptoms may be treated by local cold applications and/or the use of oral antihistamines, but they should be considered a warning of possible severe systemic reactions.


2. Systemic Reactions

With careful attention to dosage and administration, such reactions occur infrequently, but it must be remembered that allergenic extracts are highly potent in sensitive individuals and OVERDOSE could result in anaphylactic symptoms. Therefore, it is imperative that physicians administering allergenic extracts understand and be prepared for the treatment of severe reactions. Adverse reaction frequency data for allergenic extract administration for testing and treatment show that risk is low.7, 8 It cannot be overemphasized that, under certain unpredictable combinations of circumstances, anaphylactic shock is a possibility. Other possible systemic reaction symptoms, in varying degrees of severity, are fainting, pallor, bradycardia, hypotension, angioedema, cough, wheezing, conjunctivitis, rhinitis and urticaria. If a systemic or anaphylactic reaction does occur, apply a tourniquet above the site of injection, if tests are performed on the arms, and inject the 1:1000 epinephrine-hydrochloride intramuscularly or subcutaneously into the opposite arm. Loosen the tourniquet at least every 10 minutes. Do not obstruct arterial blood flow with the tourniquet.




EPINEPHRINE:

ADULT DOSAGE: 0.3 to 0.5 mL should be injected. Repeat in 5 to 10 minutes if necessary.

PEDIATRIC DOSAGE: The usual initial dose is 0.01 mg (mL) per kg body weight or 0.3 mg (mL) per square meter of body surface area. Suggested dosage for infants to 2 years of age is 0.05 mL to 0.1 mL; for children 2 to 6 years, 0.15 mL; and children 6 to 12 years, 0.2 mL. Single pediatric doses should not exceed 0.3 mg (mL). Doses may be repeated as frequently as every 20 minutes, depending on the severity of the condition and the response of the patient. After administration of epinephrine, profound shock or vasomotor collapse should be treated with intravenous fluids, and possibly vasoactive drugs. Oxygen should be given by mask. Intravenous antihistamine, theophylline or adrenal corticosteroids may be used if necessary after adequate epinephrine and circulatory support have been given. Emergency resuscitation measures and personnel trained in their use should be available immediately in the event of a serious systemic or anaphylactic reaction not responsive to the above measures. [Ref. J. Allergy Clin. Immunol. 77 (2): 271-273, 1986]. Rarely are all of the above measures necessary; the tourniquet and epinephrine usually produce prompt responses. However, the physician should be prepared in advance for all contingencies. Promptness in beginning emergency treatment measures is of utmost importance.

OVERDOSE SECTION


See ADVERSE REACTIONS Section.

Animal Allergens Injection Dosage and Administration


1. General

Parenteral Drug Products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.


2. Intradermal Testing Methods

Cleanse the rubber stopper of the vial with liquid antiseptic before withdrawing extract. A sterile tuberculin syringe with 26-gauge, short-bevel needle should be used for the injection. The anterior surface of the upper and lower arm is preferable for testing. Cleanse the skin with soap and water or wash with alcohol or other antiseptic. Introduce the needle between the superficial layers of the skin and inject 0.02 mL of the extract. Test sites should be at least 2.5 cm apart, and no more than 10 to 20 antigens should be introduced at one time. This group can be followed with additional groups of 10, providing the reactions are not numerous or strong. The same amount of extract should be injected in each site for proper comparison. It is advisable to avoid testing with more than one allergen in the same group in each series, i.e., nuts, fish, epidermals, etc. A site should be injected with 0.02 mL of the control solution. All skin tests should be validated by appropriate positive control tests (e.g., histamine) and negative control tests [e.g., Glycerin, Albumin Saline with Phenol (0.4%), or Buffered Saline with Phenol (0.4%)]. The negative control test should be the same material as is used as a diluting fluid in the tested extracts. Diluting fluid is used in the same way as an active test extract. False positive reactions are sometimes encountered in intradermal testing, and the possibility of irritation reactions should always be taken into consideration. In cases where the patient is known to be quite sensitive, screen testing by scratch, prick or puncture method is recommended, and intradermal testing should be done with caution. The intradermal strength supplied is usually safe for testing patients presenting negative scratch, prick or puncture test reactions. It is recommended that a 1:10 dilution of the stock intradermal strength be used in preliminary testing of patients not previously screened by scratch, prick or puncture tests.


3. Use of Antigen Mixes

The use of complicated mixes of unrelated pollens for testing is not recommended since in the case of a positive reaction it does not indicate which pollen(s) are responsible, and in the case of a negative reaction, it fails to indicate whether the individual pollens at full concentration would give a positive reaction.


4. Reading Skin Test Reactions

A positive reaction consists of an urticarial wheal with surrounding erythema (resembling somewhat a mosquito bite reaction) larger than the control site. The smallest reaction considered positive is erythema with a central papule at least 5 mm in diameter. In some instances with no reaction at the control site, erythema may be considered an indication of sensitivity. In general, the size of wheal and erythema response correlates directly with the patient's sensitivity to that allergen.

Standardized Products

(a) Mites: The skin test concentrations of 30 AU/mL and 300 AU/mL in multiple dose vials are used for intradermal testing.

Intradermal skin test results in selected highly sensitive subjects are presented for reference purposes:














AU/mL that Elicited ∑E = 50 mm
Allergen
Number of

Persons
Mean
2 Std. Dev. Range
D. farinae
12
0.0609
0.0015-2.6016
D. pteronyssinus
12
0.333
0.0003-4.0077

Intradermal extracts should be used as follows:

(1) Patients with a negative scratch, prick or puncture test: Patients who do not react to a valid scratch, prick or puncture test should be tested intradermally with 0.02 to 0.05 mL of a 30 AU/mL extract solution. If this test is negative, a second intradermal test may be performed using a 300 AU/mL extract solution. The negative control used with this latter dilution should contain 0.5% glycerin.

(2) Patients tested only by the intradermal method: Patients suspected of being highly allergic should be tested with 0.02 to 0.05 mL of a solution containing 0.03 AU/mL. A negative test should be followed by repeat tests using progressively stronger concentrations until the maximum recommended strength of 300 AU/mL is reached. The negative control used with this latter dilution should contain 0.5% glycerin.

(b) Cat Hair and Cat Pelt: Intradermal endpoint titration (IET) tests were completed with Cat Pelt extract using 15 subjects to determine the mean concentration required to produce a ∑E of 50 (D50) mm.That concentration contained 0.042 BAU/mL (range 0.002 to 0.890 BAU/mL).

IET tests were completed with Cat Hair extract using 15 subjects to determine the mean concentration required to produce a ∑E of 50 mm (D50). That concentration contained 0.049 BAU/mL (range 0.006 to 0.661 BAU/mL).

Intradermal extract should be used as follows:

Intradermal Tests should be done only on patients with a negative prick or puncture test. Patients who do not react to a valid prick or puncture test should be tested intradermally with 0.02 to 0.05 mL of a 100 BAU/mL extract solution. If this test is negative, a second intradermal test may be performed using a 1,000 BAU/mL extract solution. If the intradermal dilutions were prepared from glycerinated concentrate, the negative control used with this latter dilution should contain 5% glycerin.

Standardized Cat Hair and Cat Pelt products are not interchangeable with each other or any other cat products including those labeled AU/mL.

(c) Ragweed pollen (Short Ragweed or Giant and Short Ragweed Mixture) Antigen E Assayed: The intradermal strength for Short Ragweed extract is usually 500 PNU, which by calculation contains approximately 0.7 to 3 units of Antigen E/mL. For Giant and Short Ragweed mix the suggested intradermal strength is 500 PNU, which by calculation contains 0.4 to 1.5 units of Antigen E/mL. These strengths are usually safe for testing patients previously having negative scratch, prick or puncture test reactions. A 1:10 dilution of the stock intradermal strength should be used in preliminary testing of patients not previously screened by scratch, prick, or puncture tests. A study of ragweed sensitive patients9 indicates that intradermal tests, using 0.05 mL of extract, produce positive reactions (1+ to 2+) at Antigen E concentrations of from 2.7x10 -1 to 2.7x10 -6 units per mL. The equivalent PNU range was 100 to 0.001 PNU per mL. Skin tests are graded in terms of the wheal and erythema response noted at 15 minutes. Wheal and erythema size may be recorded by actual measurement of the extent of both responses.

5. Geriatric Use


The dose is the same in patients of all age groups. Because the wheal size in response to allergen skin testing decreases with age, appropriate histamine positive control skin tests must be performed.1



6. Pediatric Use


The dose is the same in patients of all age groups. Wheal size in response to allergen skin testing can be smaller in infants than in adults. Appropriate histamine positive control skin tests must be performed.1


Refer to the following table to determine the skin test sensitivity grade. The corresponding ∑E (sum of the longest diameter and the mid-point orthogonal diameters of erythema) is also presented.































Grade
Erythema

mm
Papule or Wheal

mm
Coresponding

mm ∑E
0
<5
<5
<10
±
5-10
5-10
10-20
1+
11-20
5-10
20-40
2+
21-30
5-10
40-60
3+
31-40
10-15 (a)
60-80
4+
>40
>15 (b)
> 80

a or with pseudopods


b or with many pseudopods


A positive skin reaction to any allergen must be interpreted in light of the patient’s history of symptoms, time of year, known exposures, and eating habits.

THE SKIN TESTS ARE IN NO WAY A SUBSTITUTE FOR A CAREFUL ALLERGENIC HISTORY; RATHER, THEY SERVE AS ADDITIONAL INFORMATION TO AID IN IDENTIFYING CAUSATIVE ALLERGENS IN PATIENTS WITH ALLERGIC DISORDERS.



How is Animal Allergens Injection Supplied


Most allergens are available in multiple dose 5 mL vials at PNU, w/v, some mixes as Concentrate, Standardized Mite products at AU/mL (30 AU/mL and 300 AU/mL each species), or Standardized Grass products at BAU/mL [100 BAU/mL and 1,000 BAU/mL (Bermuda 100 BAU/mL only)]. Product labels state vials are for intradermal testing and list strengths.



STORAGE


The expiration date of the diagnostic extracts is listed on the container label. The extract should be stored at 2° to 8°C, and kept at this temperature range during office use.

LIMITED WARRANTY


A number of factors beyond our control could reduce the efficacy of this product or even result in an ill effect following its use. These include storage and handling of the product after it leaves our hands, diagnosis, dosage, method of administration and biological differences in individual patients. Because of these factors, it is important that this product be stored properly, and that the directions be followed carefully during use. No warranty, express or implied, including any warranty of merchantability or fitness, is made. Representatives of the Company are not authorized to vary the terms or the contents of any printed labeling, including the package insert, for this product except by printed notice from the Company’s headquarters. The prescriber and user of this product must accept the terms hereof.



REFERENCES


1. Middleton, Elliott, Jr., C. E. Reed and E. F. Ellis (Eds.) Allergy Principles and Practice. Vol. 1, C. V. Mosby, 1978.

2. Sheldon, J. M., R. C. Lovell, and K. P. Mathews. A Manual of Clinical Allergy. W. B. Saunders, 1967.

3. Tuft, L. and H. L. Mueller, Allergy in Children. W. B. Saunders, 1979.

4. DuBuske, L.M., C.J. Ling and A.L. Sheffer. Special problems regarding allergen immunotherapy. Immunol. Allergy. Clin. North Am. (USA). 12(1): 145-175, 1992.

5. Weinstein, A. M., D. B. Dubin, W. K. Podleski, L. L. Spector and R. S. Farr. Asthma and pregnancy. JAMA 134(11): 1161-1165, 1979.

6. Jacobs, Robert L., Goeffrey W. Rake, Jr., et al. Potentiated anaphylaxis in patients with drug-induced beta-adrenergic blockade. J. Allergy Clin. Immunol. 68(2): 125-127, August 1981.

7. Lockey, Richard F., Linda M. Benedict, Paul C. Turkeltaub, Samuel C. Bukantz. Fatalities from immunotherapy (IT) and skin testing (ST). J. Allergy Clin. Immunol. 79(4): 660-677, 1987.

8. Turkeltaub, Paul C., MD, and Peter J. Gergen, MD. The risk of adverse reactions from percutaneous prick-puncture allergen skin testing, venipuncture, and body measurements: Data from the second National Health and Nutrition Examination Survey 1976-80 (NHANES II). J. Allergy Clin. Immunol. 84(6): 886-890, Dec. 1989.

9. Norman, P. S., L. M. Lichtenstein, and K. Ishizaka. Diagnostic tests in ragweed hay fever. J. Allergy Clin. Immunol. 52(4): 212-224, 1973.

10. Pipkorn, Ulf. Pharmacological influence of anti-allergic medication on In Vivo allergen testing. Allergy. 43: 81-86, 1988.

11. Andersson, M. and U. Pipkorn. Inhibition of the dermal immediate allergic reaction through prolonged treatment with topical glucocorticosteroids. J. Allergy Clin. Immunol. 79(2): 345-349, February 1987.

12. Rao, Kamineni S., et al. Duration of suppressive effect of tricyclic anti-depressants on histamine induced wheal and flare reactions on human skin. J. Allergy Clin. Immunol. 82: 752-757, November 1988.

13. Pipkorn, Ulf, and M. Andersson. Topical dermal anesthesia inhibits the flare but not the wheal response to allergen and histamine in the skin prick test. Clinical Allergy. 17: 307-311, 1987.

14. Turkeltaub, Paul C., C. Rastogi Suresh, Harold Baer. Office of Biologics Research and Review skin test method for evaluation of subject sensitivity to standardized allergenic extracts and for assignment of allergy units to reference preparations using the ID50EAL method (Intradermal Dilution for 50 mm Sum of Erythema Determines the Allergy Unit). Methods of the Allergenic Products Branch Office of Biologics Research and Review, FDA, Bethesda, MD 20892. Revised May 9, 1986.

15. Food and Drug Administration. Bilogical products; Allergenic extracts classified in Category IIIB; Final order; Revocation of licenses. Federal Register. 59(220):59228ff, November 16, 1994.









ANIMAL ALLERGENS, AP HORSE HAIR AND DANDER 
ap horse hair and dander  injection, solution










Product Information
Product TypeNON-STANDARDIZED ALLERGENICNDC Product Code (Source)65044-4857
Route of AdministrationINTRADERMALDEA Schedule    











Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Equus caballus hair (Equus caballus hair)Equus caballus hair0.0005 g  in 1 mL
Equus caballus dander (Equus caballus dander)Equus caballus dander0.0005 g  in 1 mL












Inactive Ingredients
Ingredient NameStrength
phenol 
sodium chloride 
sodium bicarbonate 
glycerin 


















Product Characteristics
Color    Score    
ShapeSize
FlavorImprint Code
Contains      










Packaging
#NDCPackage DescriptionMultilevel Packaging
165044-4857-55 mL In 1 VIALNone










Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
BLABLA10388801/30/1978







ANIMAL ALLERGENS, AP CATTLE HAIR AND DANDER 
cattle hair and dander  injection, solution










Product Information
Product TypeNON-STANDARDIZED ALLERGENICNDC Product Code (Source)65044-4813
Route of AdministrationINTRADERMALDEA Schedule    











Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Bos taurus hair (Bos taurus hair)Bos taurus hair0.0005 g  in 1 mL
Bos taurus dander (Bos taurus dander)Bos taurus dander0.0005 g  in 1 mL












Inactive Ingredients
Ingredient NameStrength
phenol 
sodium chloride 
sodium bicarbonate 
glycerin 


















Product Characteristics
Color    Score    
ShapeSize
FlavorImprint Code
Contains      










Packaging
#NDCPackage DescriptionMultilevel Packaging
165044-4813-55 mL In 1 VIALNone










Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
BLABLA10388801/30/1978







ANIMAL ALLERGENS, FEATHER MIX 
feather mix  injection, solution










Product Information
Product TypeNON-STANDARDIZED ALLERGENICNDC Product Code (Source)65044-4351
Route of AdministrationINTRADERMALDEA Schedule    














Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Gallus gallus Feather (Gallus gallus feather)Gallus gallus Feather200 [PNU]  in 1 mL
Anas platyrhynchos feather (Anas platyrhynchos feather)Anas platyrhynchos feather200 [PNU]  in 1 mL
Anser anser feather (Anser anser feather)Anser anser feather200 [PNU]  in 1 mL












Inactive Ingredients
Ingredient NameStrength
phenol 
sodium chloride 
sodium bicarbonate 
glycerin 


















Product Characteristics
Color    Score    
ShapeSize
FlavorImprint Code
Contains      










Packaging
#NDCPackage DescriptionMultilevel Packaging
165044-4351-55 mL In 1 VIALNone










Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
BLABLA10388804/19/1941







AP HOUSE DUST MIX 
ap house dust mix  injection, solution










Product Information
Product TypeNON-STANDARDIZED ALLERGENICNDC Product Code (Source)65044-4706
Route of AdministrationINTRADERMALDEA Schedule    








Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
House Dust (House Dust)House Dust500 [PNU]  in 1 mL












Inactive Ingredients
Ingredient NameStrength
phenol 
sodium chloride 
sodium bicarbonate 
glycerin 


















Product Characteristics
Color    Score    
ShapeSize
FlavorImprint Code
Contains      










Packaging
#NDCPackage DescriptionMultilevel Packaging
165044-4706-55 mL In 1 VIALNone










Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
BLABLA10388808/17/1972







DUST, HOUSE MIXTURE 
dust, house mixture  injection, solution










Product Information
Product TypeNON-STANDARDIZED ALLERGENICNDC Product Code (Source)65044-4702
Route of AdministrationINTRADERMALDEA Schedule    








Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
House Dust (House Dust)House Dust1000 [PNU]  in 1 mL












Inactive Ingredients
Ingredient NameStrength
phenol 
sodium chloride 
sodium bicarbonate 
glycerin 


















Product Characteristics
Color    Score    
ShapeSize
FlavorImprint Code
Contains      










Packaging
#NDCPackage DescriptionMultilevel Packaging
165044-4702-55 mL In 1 VIALNone










Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
BLABLA10388804/19/1941


INSECTS (WHOLE BODY) COCKROACH MIX 
insects (whole body) cockroach mix  injection, solution





Product Information
Product TypeNON-STANDARDIZED ALLERGENICNDC Product Code (Source)

Tylenol Cold Relief Nighttime Caplet


Generic Name: acetaminophen and diphenhydramine (a SEET a MIN oh fen and DYE fen HYE dra meen)

Brand Names: Anacin P.M. Aspirin Free, Coricidin Night Time Cold Relief, Excedrin PM, Excedrin PM Caplet, Excedrin PM Express Gels, Headache Relief PM, Legatrin PM, Mapap PM, Midol PM, Night Time Pain, Percogesic Extra Strength, Percogesic Original Strength, Tylenol Cold Relief Caplet, Tylenol Cold Relief Nighttime, Tylenol Cold Relief Nighttime Caplet, Tylenol Extra Strength PM, Tylenol Extra Strength PM Rapid Release Gelcaps, Tylenol Extra Strength PM Vanilla Caplet, Tylenol PM, Tylenol Sore Throat Nighttime, Unisom with Pain Relief


What is Tylenol Cold Relief Nighttime Caplet (acetaminophen and diphenhydramine)?

Acetaminophen is a pain reliever and fever reducer.


Diphenhydramine is an antihistamine that reduces the natural chemical histamine in the body. Histamine can produce symptoms of sneezing, itching, watery eyes, and runny nose.


The combination of acetaminophen and diphenhydramine is used to treat headache, fever, body aches, runny or stuffy nose, sneezing, itching, watery eyes, and sinus congestion caused by allergies, the common cold, or the flu.


Acetaminophen and diphenhydramine may also be used for purposes not listed in this medication guide.


What is the most important information I should know about Tylenol Cold Relief Nighttime Caplet (acetaminophen and diphenhydramine)?


Do not take more of this medication than is recommended. An overdose of acetaminophen can damage your liver or cause death. Do not take this medication without a doctor's advice if you have ever had alcoholic liver disease (cirrhosis) or if you drink more than 3 alcoholic beverages per day. You should not use this medicine if you have severe constipation, a blockage in your stomach or intestines, or if you are unable to urinate. Do not use this medicine if you have untreated or uncontrolled diseases such as glaucoma, asthma or COPD, heart disease, or overactive thyroid. Avoid drinking alcohol. It may increase your risk of liver damage while taking acetaminophen and can increase certain side effects of diphenhydramine. Ask a doctor or pharmacist before using any other cold, allergy, pain, or sleep medication. Acetaminophen (sometimes abbreviated as APAP) is contained in many combination medicines. Taking certain products together can cause you to get too much acetaminophen which can lead to a fatal overdose.

What should I discuss with my healthcare provider before taking Tylenol Cold Relief Nighttime Caplet (acetaminophen and diphenhydramine)?


You should not use this medicine if you have severe constipation, a blockage in your stomach or intestines, or if you are unable to urinate. Do not take this medication without a doctor's advice if you have ever had alcoholic liver disease (cirrhosis) or if you drink more than 3 alcoholic beverages per day. You may not be able to take medicine that contains acetaminophen. Do not use this medicine if you have untreated or uncontrolled diseases such as glaucoma, asthma or COPD, high blood pressure, heart disease, coronary artery disease, or overactive thyroid.

Ask a doctor or pharmacist if it is safe for you to take this medicine if you have:



  • liver disease, cirrhosis, or a history of alcoholism;




  • a blockage in your digestive tract (stomach or intestines);




  • kidney disease;




  • cough with mucus, or cough caused by smoking, emphysema, or chronic bronchitis;




  • enlarged prostate or urination problems;




  • low blood pressure; or




  • if you take potassium (Cytra, Epiklor, K-Lyte, K-Phos, Kaon, Klor-Con, Polycitra, Urocit-K).




It is not known whether acetaminophen and diphenhydramine will harm an unborn baby. Do not use this medicine without your doctor's advice if you are pregnant. This medication may pass into breast milk and may harm a nursing baby. Antihistamines and decongestants may also slow breast milk production. Do not use this medicine without your doctor's advice if you are breast-feeding a baby.

How should I take Tylenol Cold Relief Nighttime Caplet (acetaminophen and diphenhydramine)?


Use exactly as directed on the label, or as prescribed by your doctor. Do not use in larger or smaller amounts or for longer than recommended. This medicine is usually taken only for a short time until your symptoms clear up.


Do not take more of this medication than is recommended. An overdose of acetaminophen can damage your liver or cause death.

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


Do not give this medication to a child younger than 4 years old. Always ask a doctor before giving a cough or cold medicine to a child. Death can occur from the misuse of cough and cold medicines in very young children.

Do not take for longer than 7 days in a row. Stop taking the medicine and call your doctor if you still have a fever after 3 days of use, you still have pain after 7 days (or 5 days if treating a child), if your symptoms get worse, or if you have a skin rash, ongoing headache, or any redness or swelling.


If you need surgery or medical tests, tell the surgeon or doctor ahead of time if you have taken this medicine within the past few days. Store at room temperature away from moisture and heat. Do not allow liquid medicine to freeze.

What happens if I miss a dose?


Since this medicine is taken when needed, you may not be on a dosing schedule. If you are taking the medication regularly, take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.


What happens if I overdose?


Seek emergency medical attention or call the Poison Help line at 1 800 222 1222. An overdose of acetaminophen can be fatal.

The first signs of an acetaminophen overdose include loss of appetite, nausea, vomiting, stomach pain, sweating, and confusion or weakness. Later symptoms may include pain in your upper stomach, dark urine, and yellowing of your skin or the whites of your eyes.


Overdose symptoms may also include severe forms of some of the side effects listed in this medication guide.


What should I avoid while taking Tylenol Cold Relief Nighttime Caplet (acetaminophen and diphenhydramine)?


Ask a doctor or pharmacist before using any other cold, allergy, pain, or sleep medication. Acetaminophen (sometimes abbreviated as APAP) is contained in many combination medicines. Taking certain products together can cause you to get too much acetaminophen which can lead to a fatal overdose. Check the label to see if a medicine contains acetaminophen or APAP. Avoid drinking alcohol. It may increase your risk of liver damage while taking acetaminophen, and can increase certain side effects of diphenhydramine. This medicine may cause blurred vision or impair your thinking or reactions. Be careful if you drive or do anything that requires you to be alert and able to see clearly.

Tylenol Cold Relief Nighttime Caplet (acetaminophen and diphenhydramine) side effects


Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat. Stop using this medication and call your doctor at once if you have a serious side effect such as:

  • chest pain, rapid pulse, fast or uneven heart rate;




  • confusion, hallucinations, severe nervousness;




  • tremor, seizure (convulsions);




  • easy bruising or bleeding, unusual weakness;




  • urinating less than usual or not at all; or




  • nausea, pain in your upper stomach, itching, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of your skin or eyes).



Less serious side effects may include:



  • dizziness, drowsiness;




  • mild headache;




  • dry mouth, nose, or throat;




  • constipation;




  • blurred vision;




  • feeling nervous; or




  • sleep problems (insomnia);



This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.


What other drugs will affect Tylenol Cold Relief Nighttime Caplet (acetaminophen and diphenhydramine)?


Ask a doctor or pharmacist before using this medicine if you regularly use other medicines that make you sleepy (such as narcotic pain medication, sedatives, sleeping pills, muscle relaxers, and medicine for seizures, depression or anxiety). They can add to sleepiness caused by diphenhydramine.

Tell your doctor about all other medicines you use, especially:



  • leflunomide (Arava);




  • topiramate (Topamax);




  • zonisamide (Zonegran);




  • diphenhydramine (Benadryl) applied to the skin;




  • an antibiotic, antifungal medicine, sulfa drug, or tuberculosis medicine;




  • an antidepressant;




  • birth control pills or hormone replacement therapy;




  • bladder or urinary medications;




  • blood pressure medication;




  • a bronchodilator;




  • cancer medicine;




  • cholesterol-lowering medications such as Lipitor, Niaspan, Zocor, Vytorin, and others;




  • gout or arthritis medications (including gold injections);




  • HIV/AIDS medication;




  • medication for nausea and vomiting, stomach ulcers, or irritable bowel syndrome;




  • medicines to treat psychiatric disorders;




  • an NSAID such as Advil, Aleve, Arthrotec, Cataflam, Celebrex, Indocin, Motrin, Naprosyn, Treximet, Voltaren, others; or




  • seizure medication.



This list is not complete and other drugs may interact with acetaminophen and diphenhydramine. Tell your doctor about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal products. Do not start a new medication without telling your doctor.



More Tylenol Cold Relief Nighttime Caplet resources


  • Tylenol Cold Relief Nighttime Caplet Side Effects (in more detail)
  • Tylenol Cold Relief Nighttime Caplet Use in Pregnancy & Breastfeeding
  • Drug Images
  • Tylenol Cold Relief Nighttime Caplet Drug Interactions
  • Tylenol Cold Relief Nighttime Caplet Support Group
  • 13 Reviews for Tylenol Cold Relief Nighttime Caplet - Add your own review/rating


Compare Tylenol Cold Relief Nighttime Caplet with other medications


  • Headache
  • Insomnia
  • Pain


Where can I get more information?


  • Your pharmacist can provide more information about acetaminophen and diphenhydramine.

See also: Tylenol Cold Relief Nighttime Caplet side effects (in more detail)


Sodium Picosulfate




Scheme

Rec.INN

ATC (Anatomical Therapeutic Chemical Classification)

A06AB08

CAS registry number (Chemical Abstracts Service)

0010040-45-6

Chemical Formula

C18-H13-N-Na2-O8-S2

Molecular Weight

481

Therapeutic Categories

Laxative, antiresorptive and/or secretagogue

Stimulant laxative

Chemical Name

Phenol, 4,4'-(2-pyridinylmethylene)bis-, bis(hydrogen sulfate) (ester), disodium salt

Foreign Names

  • Natrii picosulfas (Latin)
  • Natrium picosulfat (German)
  • Picosulfate de sodium (French)
  • Picosulfato sodico (Spanish)

Generic Names

  • Picosulfate de sodium (OS: DCF)
  • Picosulfato sodico (OS: DCIT)
  • Sodium Picosulfate (OS: JAN, BAN)
  • DA 1773 (IS)
  • LA 391 (IS)
  • Sodium Picosulphate (IS)
  • Natrii picosulfas (PH: Ph. Eur. 6, Ph. Eur. 6)
  • Sodium Picosulfate (PH: Ph. Eur. 6, BP 2007, Ph. Eur. 6)
  • Natriumpicosulfat (PH: Ph. Eur. 6)
  • Sodium (picosulfate de) (PH: Ph. Eur. 6)
  • Sodium Picosulfate (PH: BP 2010)

Brand Names

  • Actilax
    Medic, Denmark


  • Agaffin Abführgel
    Merck, Austria


  • Agarol chicles
    Interbelle, Argentina


  • Agarol
    Johnson & Johnson, Peru; Pfizer, Argentina; Pfizer, Colombia


  • Agiolax Pico
    Rottapharm/Madaus, Germany


  • Agiopic
    Madaus, Austria


  • Anara
    Chinoin, Costa Rica; Chinoin, Dominican Republic; Chinoin, Guatemala; Chinoin, Mexico; Chinoin, Nicaragua; Chinoin, Panama; Chinoin, El Salvador


  • Chaldol
    Taiyo Pharmaceutical, Japan


  • Cirulaxia
    Altana, Argentina


  • Contumax
    Casen, Spain


  • Cremalax
    Abbott, India


  • Dagol Cetus
    Cetus, Argentina


  • Darmol
    Omegin, Germany


  • Dibrolax
    Farmindustria, Peru; K2 Pharmavida, Peru


  • Dulco-lax perles
    Boehringer Ingelheim, Ireland


  • Dulcolax
    Boehringer Ingelheim, Argentina; Boehringer Ingelheim, Belgium; Boehringer Ingelheim, Chile; Boehringer Ingelheim, United Kingdom


  • Dulcolax Picosulfat Pearls
    Boehringer Ingelheim, Switzerland


  • Euchessina CM
    Antonetto, Italy


  • Evacuol
    Almirall, Spain


  • Ezor
    Lainco, Spain


  • Factor Laxante Ilab
    Inmunolab, Argentina


  • Falquigut gocce
    Falqui, Italy


  • Feen-A-Mint
    Interbelle, Argentina


  • Fisiolax
    Ethical, Dominican Republic


  • Fructines
    DB, France; Pharmethic, Belgium; Uhlmann-Eyraud Pharma, Switzerland


  • Gocce
    SIT, Italy


  • Gotalax
    Mertens, Argentina


  • Gutalax
    Boehringer Ingelheim, Spain


  • Guttalax
    Boehringer Ingelheim, Austria; Boehringer Ingelheim, Brazil; Boehringer Ingelheim, Czech Republic; Boehringer Ingelheim, Estonia; Boehringer Ingelheim, Georgia; Boehringer Ingelheim, Greece; Boehringer Ingelheim, Hungary; Boehringer Ingelheim, Italy; Boehringer Ingelheim, Lithuania; Boehringer Ingelheim, Latvia; Boehringer Ingelheim, Malta; Boehringer Ingelheim, Portugal; Boehringer Ingelheim, Russian Federation; Boehringer Ingelheim, Slovakia; Silesia, Chile; Wolfs, Luxembourg


  • Kritel
    Monserrat, Argentina; Monserrat, Argentina


  • Laxamin
    Temis-Lostalo, Argentina


  • Laxantil
    Chemopharma, Chile


  • Laxasan
    Gebro, Austria; Gebro, Switzerland


  • Laxatol
    Omega, Greece


  • Laxoberal
    Boehringer Ingelheim, Chile; Boehringer Ingelheim, Denmark; Boehringer Ingelheim, Ireland; Boehringer Ingelheim, Malta; Boehringer Ingelheim, Norway; Boehringer Ingelheim, Sweden; Teijin Pharma, Japan


  • Laxoberon
    Boehringer Ingelheim, Belgium; Boehringer Ingelheim, Switzerland; Boehringer Ingelheim, Colombia; Boehringer Ingelheim, Finland; Boehringer Ingelheim, Indonesia; Boehringer Ingelheim, Luxembourg; Boehringer Ingelheim, Mexico; Boehringer Ingelheim, Peru; Teijin Pharma, Japan


  • Laxodal
    Baldacci, Portugal


  • Laxolax
    Roxfarma, Peru


  • Laxygal
    Ivax, Czech Republic; Ivax, Estonia; Ivax, Hungary; Ivax, Lithuania; Ivax, Latvia; Teva, Slovakia


  • Lubrilax
    Normon, Spain


  • Natrijum pikosulfat
    Zdravlje, Serbia


  • Picate
    Candor, India


  • Picolax
    Eipico, United Arab Emirates; Eipico, Bahrain; Eipico, Iraq; Eipico, Jordan; Eipico, Kuwait; Eipico, Lebanon; Eipico, Libya; Eipico, Oman; Eipico, Qatar; Eipico, Saudi Arabia; Eipico, Sudan; Eipico, Yemen; Ferring, Ireland; Neo-Farmacêutica, Portugal


  • Picolaxine
    Pharmacobel, Belgium


  • Picolon
    Medic, Denmark


  • Pilules de Vichy
    Omega, Belgium; Omega, Luxembourg


  • Rapilax
    Merck, Argentina


  • Regulax Picosulphate
    Krewel, Latvia


  • Regulax
    Krewel, Germany; Krewel, Estonia; Krewel Meuselbach, Georgia


  • Skilax
    Almirall, Burkina Faso; Almirall, Benin; Almirall, Congo; Almirall, Cote D'ivoire; Almirall, Cameroon; Almirall, Spain; Almirall, Gabon; Almirall, Guinea; Almirall, Madagascar; Almirall, Mali; Almirall, Mauritania; Almirall, Mauritius; Almirall, Niger; Almirall, Senegal; Almirall, Chad; Almirall, Togo; Almirall, Zaire; Prodes, Oman; Refasa, Peru


  • Trali
    Pfizer, Argentina


  • Uphatin
    Uphace, Vietnam


  • Verilax
    Laboratorios, Argentina


  • Yodolin
    Hexa, Argentina


  • Aperil
    Nichi-Iko PharmaceuticalJMA, Japan


  • Berberon
    Nichi-Iko PharmaceuticalJMA, Japan


  • Cilaxoral
    Ferring, Sweden


  • Dulcolax Pico
    Istituto de Angeli, Bulgaria


  • Dulcolax NP
    Boehringer Ingelheim, Germany


  • Dulcolax Picosulfat
    Boehringer Ingelheim, Switzerland


  • Dulcopic
    Boehringer Ingelheim, Romania


  • Falestack
    Towa Yakuhin, Japan


  • Farthrough
    Fushimi Seiyaku, Japan


  • Flurale
    Takata Seiyaku, Japan


  • Konsuben
    Tsuruhara Seiyaku, Japan


  • Laxaid
    Toyo Seiyaku KaseiOriental, Japan


  • Laxans-ratiopharm Pico
    Ratiopharm, Germany


  • Laxoberal
    Boehringer Ingelheim, Germany


  • Laxoberon
    Boehringer Ingelheim, Finland


  • Laxodate
    Kobayashi Kako, Japan


  • Laxoselin
    Choseido Pharmaceutical, Japan


  • Panhodiel
    Nipro GenephaNipurojenefa, Japan


  • Picoben
    Nippon Universal Pharmaceutical, Japan


  • Picodarm
    Nisshin Seiyaku - Yamagata, Japan


  • Picorula
    Nihon Seiyaku, Japan


  • Picoslon
    Teikoku Medix, Japan


  • Picosulfat
    Toyo Capseru, Japan


  • Regulax Picosulfat
    Krewel, Czech Republic; Krewel, Germany; Krewel Meuselbach, Lithuania


  • Shinluck
    Iwaki Seiyaku, Japan


  • Sultimin
    Sawai Seiyaku, Japan


  • Sunailin
    Abbott, Japan


  • Youpis
    Isei, Japan

International Drug Name Search

Glossary

BANBritish Approved Name
DCFDénomination Commune Française
DCITDenominazione Comune Italiana
ISInofficial Synonym
JANJapanese Accepted Name
OSOfficial Synonym
PHPharmacopoeia Name
Rec.INNRecommended International Nonproprietary Name (World Health Organization)

Click for further information on drug naming conventions and International Nonproprietary Names.

Di-Fedril




Di-Fedril may be available in the countries listed below.


Ingredient matches for Di-Fedril



Diphenhydramine

Diphenhydramine hydrochloride (a derivative of Diphenhydramine) is reported as an ingredient of Di-Fedril in the following countries:


  • Venezuela

International Drug Name Search