Tetracycline

Pronunciation: tet-ra-SYE-kleen
Generic Name: Tetracycline
Brand Name: Sumycin

Tetracycline is used for:

Treating infections caused by certain bacteria.

Tetracycline is a tetracycline antibiotic. It works by slowing the growth of sensitive bacteria by interfering with the production of proteins needed by the bacteria to grow. Slowing the bacteria's growth allows the body's defense mechanisms to destroy them.

Do NOT use Tetracycline if:

• you are allergic to any ingredient in Tetracycline or other tetracycline antibiotics (eg, doxycycline)


• you are taking acitretin or methoxyflurane

Contact your doctor or health care provider right away if any of these apply to you.

Before using Tetracycline:

Some medical conditions may interact with Tetracycline. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

• if you are pregnant, planning to become pregnant, or are breast-feeding


• if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement


• if you have allergies to medicines, foods, or other substances


• if you have diarrhea, a stomach infection, or kidney problems

Some MEDICINES MAY INTERACT with Tetracycline. Tell your health care provider if you are taking any other medicines, especially any of the following:

• Acitretin or isotretinoin because side effects, such as increased pressure in the fluid surrounding the brain, may occur


• Digoxin, methotrexate, methoxyflurane, or oral anticoagulants (eg, warfarin) because the risk of their side effects may be increased by Tetracycline


• Atovaquone, lithium, oral contraceptives (birth control pills), or penicillins (eg, amoxicillin) because their effectiveness may be decreased by Tetracycline

This may not be a complete list of all interactions that may occur. Ask your health care provider if Tetracycline may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use Tetracycline:

Use Tetracycline as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• Take Tetracycline by mouth on an empty stomach at least 1 hour before or 2 hours after eating.


• Take Tetracycline with a full glass of water (8 oz/240 mL). Do not lie down for 30 minutes after taking Tetracycline.


• If you also take antacids containing aluminum, calcium, or magnesium; preparations containing bismuth, iron, zinc, or sodium bicarbonate; or calcium rich foods (eg, milk, dairy products, calcium-enriched juices), do not take them within 2 to 3 hours before or after taking Tetracycline. Check with your doctor if you have questions.


• To clear up your infection completely, take Tetracycline for the full course of treatment. Keep taking it even if you feel better in a few days.


• If you miss a dose of Tetracycline, take it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once.

Ask your health care provider any questions you may have about how to use Tetracycline.

Important safety information:

• Tetracycline may cause dizziness or blurred vision. These effects may be worse if you take it with alcohol or certain medicines. Use Tetracycline with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.


• Contact your doctor right away if stomach pain or cramps, severe diarrhea, or bloody stools occur. Do not treat diarrhea without first checking with your doctor.


• Be sure to use Tetracycline for the full course of treatment. If you do not, the medicine may not clear up your infection completely. The bacteria could also become less sensitive to this or other medicines. This could make the infection harder to treat in the future.


• Tetracycline may cause you to become sunburned more easily. Avoid the sun, sunlamps, or tanning booths until you know how you react to Tetracycline. Use a sunscreen or wear protective clothing if you must be outside for more than a short time.


• Do not use after expiration date. Outdated medicine is highly toxic to the kidneys.


• Long-term or repeated use of Tetracycline may cause a second infection. Tell your doctor if signs of a second infection occur. Your medicine may need to be changed to treat this.


• Hormonal birth control (eg, birth control pills) may not work as well while you are using Tetracycline. To prevent pregnancy, use an extra form of birth control (eg, condoms).


• Lab tests may be performed while you use Tetracycline. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.


• Use of Tetracycline in CHILDREN may cause permanent discoloring of the teeth.


• Tetracycline should be used with extreme caution in CHILDREN younger than 8 years old; safety and effectiveness in these children have not been confirmed.


• PREGNANCY and BREAST-FEEDING: Tetracycline has been shown to cause harm to the fetus. If you think you may be pregnant, contact your doctor. You will need to discuss the benefits and risks of using Tetracycline while you are pregnant. Tetracycline is found in breast milk. Do not breast-feed while taking Tetracycline.

Possible side effects of Tetracycline:

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Black hairy tongue; blurred vision; bulky loose stools; diarrhea; difficulty swallowing; fever; headache; hives; hoarseness; indigestion; inflammation or redness of tongue; joint pain; loss of appetite; mouth sores; nausea; rash; sensitivity to sunlight; sore throat; stomach pain; swelling and itching of the rectum.

Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); infection (fever, chills, sore throat); itching; nausea; severe skin reaction to the sun; vaginal irritation or discharge; vomiting.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately.

Proper storage of Tetracycline:

Store Tetracycline at room temperature, between 68 and 77 degrees F (20 and 25 degrees C), in a tightly closed, light-resistant container. Keep away from heat, moisture, and light. Do not store in the bathroom. Keep Tetracycline out of the reach of children and away from pets.

General information:

• If you have any questions about Tetracycline, please talk with your doctor, pharmacist, or other health care provider.


• Tetracycline is to be used only by the patient for whom it is prescribed. Do not share it with other people.


• If your symptoms do not improve or if they become worse, check with your doctor.


• Check with your pharmacist about how to dispose of unused medicine.

This information is a summary only. It does not contain all information about Tetracycline. If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.

Issue Date: February 1, 2012

Database Edition 12.1.1.002

Copyright © 2012 Wolters Kluwer Health, Inc.

More Tetracycline resources

• Tetracycline Dosage
• Tetracycline Use in Pregnancy & Breastfeeding
• Drug Images
• Tetracycline Drug Interactions
• Tetracycline Support Group
• 5 Reviews for Tetracycline - Add your own review/rating

• Tetracycline Monograph (AHFS DI)


• Tetracycline Prescribing Information (FDA)


• tetracycline Concise Consumer Information (Cerner Multum)


• tetracycline Mucous membrane, oral Advanced Consumer (Micromedex) - Includes Dosage Information


• Sumycin Prescribing Information (FDA)

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Fluorouracil Topical Solution

Fluorouracil Topical SolutionS

Rx only

FOR TOPICAL USE ONLY - NOT FOR OPHTHALMIC, ORAL, OR INTRAVAGINAL USE.

DESCRIPTION

Fluorouracil Solutions are topical preparations containing the fluorinated pyrimidine 5-fluorouracil, an antineoplastic antimetabolite.

Fluorouracil Solution consists of 2% or 5% fluorouracil on a weight/weight basis, compounded with propylene glycol, tris (hydroxymethyl) aminomethane, hydroxypropyl cellulose, parabens (methyl and propyl), disodium edentate and purified water.

Chemically, fluorouracil is 5-fluoro-2,4(1H,3H)-pyrimidinedione. It is a white to practically white, crystalline powder which is sparingly soluble in water and slightly soluble in alcohol. One gram of fluorouracil is soluble in 100 mL of propylene glycol. The molecular weight of 5-fluorouracil is 130.08 and the structural formula is:

CLINICAL PHARMACOLOGY

There is evidence that the metabolism of fluorouracil in the anabolic pathway blocks the methylation reaction of deoxyuridylic acid to thymidylic acid. In this manner fluorouracil interferes with the synthesis of deoxyribonucleic acid (DNA) and to a lesser extent inhibits the formation of ribonucleic acid (RNA). Since DNA and RNA are essential for cell division and growth, the effect of fluorouracil may be to create a thymine deficiency which provokes unbalanced growth and death of the cell. The effects of DNA and RNA deprivation are most marked on those cells which grow more rapidly and take up fluorouracil at a more rapid rate. The catabolic metabolism of fluorouracil results in degradation products (e.g., CO2, urea, α-fluoro-β-alanine) which are inactive.

Systemic absorption studies of topically applied fluorouracil have been performed on patients with actinic keratoses using tracer amounts of 14C labeled fluorouracil added to a 5% preparation. All patients had been receiving non labeled fluorouracil until the peak of the inflammatory reaction occurred (2 to 3 weeks), ensuring that the time of maximum absorption was used for measurement. One gram of labeled preparation was applied to the entire face and neck and left in place for 12 hours. Urine samples were collected. At the end of 3 days, the total recovery ranged between 0.48% and 0.94% with an average of 0.76%, indicating that approximately 5.98% of the topical dose was absorbed systemically. If applied twice daily, this would indicate systemic absorption of topical fluorouracil to be in the range of 5 to 6 mg per daily dose of 100 mg. In an additional study, negligible amounts of labeled material were found in plasma, urine and expired CO2 after 3 days of treatment with topically applied 14C-labeled fluorouracil.

INDICATIONS & USAGE

Fluorouracil is recommended for the topical treatment of multiple actinic or solar keratoses. In the 5% strength it is also useful in the treatment of superficial basal cell carcinomas when conventional methods are impractical, such as with multiple lesions or difficult treatment sites. Safety and efficacy in other indications have not been established.

The diagnosis should be established prior to treatment, since this method has not been proven effective in other types of basal cell carcinomas. With isolated, easily accessible basal cell carcinomas, surgery is preferred since success with such lesions is almost 100%. The success rate with Fluorouracil Solution is approximately 93%, based on 113 lesions in 54 patients. Twenty-five lesions treated with the solution produced 1 failure.

CONTRAINDICATIONS

Fluorouracil may cause fetal harm when administered to a pregnant woman.

There are no adequate and well-controlled studies in pregnant women with either the topical or the parenteral forms of fluorouracil. One birth defect (cleft lip and palate) has been reported in the newborn of a patient using Fluorouracil as recommended. One birth defect (ventricular septal defect) and cases of miscarriage have been reported when Fluorouracil was applied to mucous membrane areas. Multiple birth defects have been reported in a fetus of a patient treated with intravenous fluorouracil.

Animal reproduction studies have not been conducted with Fluorouracil. Fluorouracil administered parenterally has been shown to be teratogenic in mice, rats, and hamsters when given at doses equivalent to the usual human intravenous dose; however, the amount of fluorouracil absorbed systemically after topical administration to actinic keratoses is minimal (see CLINICAL PHARMACOLOGY). Fluorouracil exhibited maximum teratogenicity when given to mice as single intraperitoneal injections of 10 to 40 mg/kg on Day 10 or 12 of gestation. Similarly, intraperitoneal doses of 12 to 37 mg/kg given to rats between Days 9 and 12 of gestation and intramuscular doses of 3 to 9 mg/kg given to hamsters between Days 8 and 11 of gestation were teratogenic and/or embryotoxic (i.e., resulted in increased resorptions or embryolethality). In monkeys, divided doses of 40 mg/kg given between Days 20 and 24 of gestation were not teratogenic. Doses higher than 40 mg/kg resulted in abortion.

Fluorouracil should not be used in patients with dihydropyrimidine dehydrogenase (DPD) enzyme deficiency. A large percentage of fluorouracil is catabolized by the DPD enzyme. DPD enzyme deficiency can result in shunting of fluorouracil to the anabolic pathway, leading to cytotoxic activity and potential toxicities.

Fluorouracil is contraindicated in women who are or may become pregnant

during therapy. If this drug is used during pregnancy, or if the patient becomes pregnant while using this drug, the patient should be apprised of the potential hazard to the fetus.

Fluorouracil is also contraindicated in patients with known hypersensitivity to any of its components.

WARNINGS

Application to mucous membranes should be avoided due to the possibility of local inflammation and ulceration. Additionally, cases of miscarriage and a birth defect (ventricular septal defect) have been reported when Fluorouracil was applied to mucous membrane areas during pregnancy.

Occlusion of the skin with resultant hydration has been shown to increase percutaneous penetration of several topical preparations. If any occlusive dressing is used in treatment of basal cell carcinoma, there may be an increase in the severity of inflammatory reactions in the adjacent normal skin. A porous gauze dressing may be applied for cosmetic reasons without increase in reaction.

Exposure to ultraviolet rays should be minimized during and immediately following treatment with Fluorouracil because the intensity of the reaction may be increased.

Patients should discontinue therapy with Fluorouracil if symptoms of DPD enzyme deficiency develop (see CONTRAINDICATIONS section).

Rarely, life-threatening toxicities such as stomatitis, diarrhea, neutropenia, and neurotoxicity have been reported with intravenous administration of fluorouracil in patients with DPD enzyme deficiency. One case of life threatening systemic toxicity has been reported with the topical use of Fluorouracil in a patient with DPD enzyme deficiency. Symptoms included severe abdominal pain, bloody diarrhea, vomiting, fever, and chills. Physical examination revealed stomatitis, erythematous skin rash, neutropenia, thrombocytopenia, inflammation of the esophagus, stomach, and small bowel. Although this case was observed with 5% fluorouracil cream, it is unknown whether patients with profound DPD enzyme deficiency would develop systemic toxicity with lower concentrations of topically applied fluorouracil.

PRECAUTIONS

General: There is a possibility of increased absorption through ulcerated or inflamed skin.

Information for Patients: Patients should be forewarned that the reaction in the treated areas may be unsightly during therapy and, usually, for several weeks following cessation of therapy. Patients should be instructed to avoid exposure to ultraviolet rays during and immediately following treatment with Fluorouracil because the intensity of the reaction may be increased. If Fluorouracil is applied with the fingers, the hands should be washed immediately afterward. Fluorouracil should not be applied on the eyelids or directly into the eyes, nose or mouth because irritation may occur.

Laboratory Tests: Solar keratoses which do not respond should be biopsied to confirm the diagnosis. Follow-up biopsies should be performed as indicated in the management of superficial basal cell carcinoma.

Carcinogenesis, Mutagenesis, Impairment of Fertility: Adequate long term studies in animals to evaluate carcinogenic potential have not been conducted with fluorouracil. Studies with the active ingredient of Fluorouracil, 5-fluorouracil, have shown positive effects in in vitro tests for mutagenicity and on impairment of fertility.

5-Fluorouracil was positive in three in vitro cell neoplastic transformation assays. In the C3H/10T1⁄ 2 clone 8 mouse embryo cell system, the resulting morphologically transformed cells formed tumors when inoculated into immunosuppressed syngeneic mice.

While no evidence for mutagenic activity was observed in the Ames test (3 studies), fluorouracil has been shown to be mutagenic in the survival count rec-assay with Bacillus subtilis and in the Drosophilia wing-hair spot test. Fluorouracil produced petite mutations in Saccharomyces cerevisiae and was positive in the micronucleus test (bone marrow cells of male mice).

Fluorouracil was clastogenic in vitro (i.e., chromatid gaps, breaks and exchanges) in Chinese hamster fibroblasts at concentrations of 1.0 and 2.0 mg/mL and has been shown to increase sister chromatid exchange in vitro in human lymphocytes. In addition, 5-fluorouracil has been reported to produce an increase in numerical and structural chromosome aberrations in peripheral lymphocytes of patients treated with this product.

Doses of 125 to 250 mg/kg, administered intraperitoneally, have been shown to induce chromosomal aberrations and changes in chromosome organization of spermatogonia in rats. Spermatogonial differentiation was also inhibited by fluorouracil, resulting in transient infertility. However, in studies with a strain of mouse which is sensitive to the induction of sperm head abnormalities after exposure to a range of chemical mutagens and carcinogens, fluorouracil was inactive at oral doses of 5 to 80 mg/kg/day. In female rats, fluorouracil administered intraperitoneally at doses of 25 and 50 mg/kg during the preovulatory phase of oogenesis significantly reduced the incidence of fertile matings, delayed the development of preimplantation and postimplantation embryos, increased the incidence of preimplantation lethality and induced chromosomal anomalies in these embryos. Single dose intravenous and intraperitoneal injections of 5-fluorouracil have been reported to kill differentiated spermatogonia and spermatocytes (at 500 mg/kg) and to produce abnormalities in spermatids (at 50 mg/kg) in mice.

Pregnancy:

Teratogenic Effects:

Pregnancy Category X: See CONTRAINDICATIONS section.

Nursing Mothers: It is not known whether Fluorouracil is excreted in human milk. Because there is some systemic absorption of fluorouracil after topical administration (see CLINICAL PHARMACOLOGY), because many drugs are excreted in human milk, and because of the potential for serious adverse reactions in nursing infants, a decision should be made whether to discontinue nursing or to discontinue use of the drug, taking into account the importance of the drug to the mother.

Pediatric Use: Safety and effectiveness in children have not been established.

ADVERSE REACTIONS

The most frequent adverse reactions to Fluorouracil occur locally and are often related to an extension of the pharmacological activity of the drug. These include burning, crusting, allergic contact dermatitis, erosions, erythema, hyperpigmentation, irritation, pain, photosensitivity, pruritus, scarring, rash, soreness and ulceration. Ulcerations, other local reactions, cases of miscarriage and a birth defect (ventricular septal defect) have been reported when Fluorouracil was applied to mucous membrane areas. Leukocytosis is the most frequent hematological side effect.

Although a causal relationship is remote, other adverse reactions which have been reported infrequently are:

Central Nervous System: Emotional upset, insomnia, irritability.

Gastrointestinal: Medicinal taste, stomatitis.

Hematological: Eosinophilia, thrombocytopenia, toxic granulation.

Integumentary: Alopecia, blistering, bullous pemphigoid, discomfort, ichthyosis, scaling, suppuration, swelling, telangiectasia, tenderness, urticaria, skin rash.

Special Senses: Conjunctival reaction, corneal reaction, lacrimation, nasal irritation.

Miscellaneous: Herpes simplex.

OVERDOSAGE

There have been no reports of overdosage with Fluorouracil.

Studies with a 5% topical solution yielded an oral LD50 of 214 mg/kg in rats and 28.5 mg/kg in dogs, corresponding to 10.7 and 1.43 mg/kg of fluorouracil, respectively.

DOSAGE & ADMINISTRATION

When Fluorouracil is applied to a lesion, a response occurs with the following sequence: erythema, usually followed by vesiculation, desquamation, erosion and reepithelialization.

Fluorouracil should be applied preferably with a nonmetal applicator or suitable glove. If Fluorouracil is applied with the fingers, the hands should be washed immediately afterward.

Actinic or Solar Keratosis: Apply solution twice daily in an amount sufficient to cover the lesions. Medication should be continued until the inflammatory response reaches the erosion stage, at which time use of the drug should be terminated. The usual duration of therapy is from 2 to 4 weeks. Complete healing of the lesions may not be evident for 1 to 2 months following cessation of Fluorouracil therapy.

Superficial Basal Cell Carcinomas: Only the 5% strength is recommended. Apply solution twice daily in an amount sufficient to cover the lesions. Treatment should be continued for at least 3 to 6 weeks. Therapy may be required for as long as 10 to 12 weeks before the lesions are obliterated. As in any neoplastic condition, the patient should be followed for a reasonable period of time to determine if a cure has been obtained.

HOW SUPPLIED

Fluorouracil Solution is available in 10-mL drop dispensers containing either 2% (NDC 43547-259-01) or 5% (NDC 43547-258-01) fluorouracil on a weight/weight basis compounded with propylene glycol, tris (hydroxymethyl) aminomethane, hydroxypropyl cellulose, parabens (methyl and propyl), disodium edentate and purified water.

Store at 25°C (77°F); excursions permitted to 15°C-30°C (59°F-86°F).

Manufactured by:

Legacy Pharmaceuticals Puerto Rico, LLC

Humacao, Puerto Rico 00791

Distributed by:


Solco Healthcare US, LLC

Humacao, Puerto Rico 00791

Rev. April, 2010

Code: 02-3608-EX-02

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Fluorouracil 2% Topical Solution

NDC 43547-259-01

Bottle Label

Carton Label

Fluorouracil 2% Topical Solution

NDC 43547-259-01

Packer Label

Fluorouracil 5% Topical Solution

NDC 43547-258-01

Bottle Label

Carton Label

FLUOROURACIL  fluorouracil  solution

Product Information Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 43547-259 Route of Administration TOPICAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength FLUOROURACIL (FLUOROURACIL) FLUOROURACIL 20 mg  in 1 mL

Inactive Ingredients Ingredient Name Strength No Inactive Ingredients Found

Product Characteristics Color      Score      Shape Size Flavor Imprint Code Contains

Packaging # NDC Package Description Multilevel Packaging 1 43547-259-01 10 mL In 1 BOTTLE, PLASTIC None

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
NDA	NDA016831	06/01/2010

FLUOROURACIL  fluorouracil  solution

Product Information Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 43547-258 Route of Administration TOPICAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength FLUOROURACIL (FLUOROURACIL) FLUOROURACIL 50 mg  in 1 mL

Inactive Ingredients Ingredient Name Strength No Inactive Ingredients Found

Product Characteristics Color      Score      Shape Size Flavor Imprint Code Contains

Packaging # NDC Package Description Multilevel Packaging 1 43547-258-01 10 mL In 1 BOTTLE, PLASTIC None

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
NDA	NDA016831	06/01/2010

Labeler - Solco Healthcare US LLC (828343017)

Registrant - Solco Healthcare US LLC (828343017)

Establishment
Name	Address	ID/FEI	Operations
Legacy Pharmaceuticals Puerto Rico LLC		026611520	ANALYSIS, API MANUFACTURE, LABEL

Revised: 05/2010Solco Healthcare US LLC

More Fluorouracil Topical Solution resources

• Fluorouracil Topical Solution Use in Pregnancy & Breastfeeding
• Fluorouracil Topical Solution Support Group
• 23 Reviews for Fluorouracil Topical - Add your own review/rating

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Verdeso Foam

Pronunciation: DES-oh-nide
Generic Name: Desonide
Brand Name: Verdeso

Verdeso Foam is used for:

Treating mild to moderate itching, redness, and swelling caused by certain skin conditions.

Verdeso Foam is a topical corticosteroid. It works by reducing skin inflammation (redness, swelling, itching, and irritation).

Do NOT use Verdeso Foam if:

• you are allergic to any ingredient in Verdeso Foam

Contact your doctor or health care provider right away if any of these apply to you.

Before using Verdeso Foam:

Some medical conditions may interact with Verdeso Foam. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

• if you are pregnant, planning to become pregnant, or are breast-feeding


• if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement


• if you have allergies to medicines, foods, or other substances


• if you have any kind of skin infection, cuts, scrapes, or lessened blood flow to your skin


• if you have measles, tuberculosis (TB), a positive TB skin test, chickenpox, or shingles, or if you have recently had a vaccination


• if you are taking an oral corticosteroid (eg, prednisone)

Some MEDICINES MAY INTERACT with Verdeso Foam. Because little, if any, of Verdeso Foam is absorbed into the blood, the risk of it interacting with another medicine is low.

Ask your health care provider if Verdeso Foam may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use Verdeso Foam:

Use Verdeso Foam as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• Wash your hands before using Verdeso Foam.


• Shake well before each use.


• Hold canister upside down to dispense the medicine. Apply the smallest amount necessary to cover the entire affected area with a thin layer of medicine as directed by your doctor. Gently rub the medicine in until it is evenly distributed.


• If you are using Verdeso Foam on your face, do NOT dispense it directly onto your face. Dispense it into your hands, and then gently massage onto your face until the medicine disappears.


• Wash your hands immediately after applying Verdeso Foam, unless your hands are part of the treated area.


• Do not cover the treated area(s) with bandages or other dressings unless advised to do so by your health care provider.


• If you miss a dose of Verdeso Foam, use it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not use 2 doses at once.

Ask your health care provider any questions you may have about how to use Verdeso Foam.

Important safety information:

• Verdeso Foam is for external use only. Do not get it in your eyes, nose, or mouth. If you get it any of these areas, flush right away with cool tap water.


• Do NOT use more than the recommended dose or use for longer than 4 weeks without checking with your doctor.


• If your symptoms do not get better within 4 weeks or if they get worse, contact your doctor.


• Talk with your doctor before you use any other medicines or cleansers on your skin.


• Do not apply Verdeso Foam over large areas of the body, to open wounds, or to scraped, infected, or burned skin without first checking with your doctor.


• Do not use Verdeso Foam for other skin conditions at a later time.


• Overuse of topical products may worsen your condition.


• If Verdeso Foam is being used to treat the diaper area of a child, avoid using tight-fitting diapers or plastic pants.


• Check with your doctor before you receive any vaccine while you are using Verdeso Foam.


• Verdeso Foam has a corticosteroid in it. Before you start any new medicine, check the label to see if it has a corticosteroid in it too. If it does or you are not sure, check with your doctor or pharmacist.


• Tell your doctor or dentist that you take Verdeso Foam before you receive any medical or dental care, emergency care, or surgery.


• Contact your doctor if you have a cut or sore that does not heal.


• Serious side effects may occur if too much of Verdeso Foam is absorbed through the skin. This may be more likely to occur if you use Verdeso Foam over a larger area of the body. It may also be more likely if you wrap or bandage the area after you apply Verdeso Foam. The risk is greater in children. Do not use more than the prescribed dose. Contact your doctor right away if you develop unusual weight gain (especially in the face), muscle weakness, increased thirst or urination, confusion, unusual drowsiness, severe or persistent headache, or vision changes. Discuss any questions or concerns with your doctor.


• Verdeso Foam is flammable. Do not store or use near an open flame or while smoking.


• Caution is advised when using Verdeso Foam in CHILDREN; they may be more sensitive to its effects.


• Corticosteroids may affect growth rate in CHILDREN and teenagers in some cases. They may need regular growth checks while they use Verdeso Foam.


• Verdeso Foam should be used with extreme caution in CHILDREN younger than 3 months old; safety and effectiveness in these children have not been confirmed.


• PREGNANCY and BREAST-FEEDING: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Verdeso Foam while you are pregnant. It is not known if Verdeso Foam is found in breast milk after topical use. If you are or will be breast-feeding while you use Verdeso Foam, check with your doctor. Discuss any possible risks to your baby.

Possible side effects of Verdeso Foam:

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Mild, temporary stinging or burning when first applied.

Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); acne-like rash; inflamed hair follicles; inflammation around the mouth; severe or persistent burning, irritation, redness, or swelling of the skin; thinning, softening, or discoloration of the skin.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

See also: Verdeso side effects (in more detail)

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately. Symptoms may include blurred vision or other vision changes; muscle weakness; severe or persistent headache; symptoms of high blood sugar (eg, increased thirst or urination, confusion, unusual drowsiness); unusual weight gain, especially in the face.

Proper storage of Verdeso Foam:

Store Verdeso Foam at room temperature, between 68 and 77 degrees F (20 and 25 degrees C). Store in a tightly closed container. Store away from heat, moisture, and light. Do not expose to heat or store at temperatures above 120 degrees F (49 degrees C). Do not puncture, break, or burn the canister even if it appears to be empty. Keep Verdeso Foam out of the reach of children and away from pets.

General information:

• If you have any questions about Verdeso Foam, please talk with your doctor, pharmacist, or other health care provider.


• Verdeso Foam is to be used only by the patient for whom it is prescribed. Do not share it with other people.


• If your symptoms do not improve or if they become worse, check with your doctor.


• Check with your pharmacist about how to dispose of unused medicine.

This information is a summary only. It does not contain all information about Verdeso Foam. If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.

Issue Date: February 1, 2012

Database Edition 12.1.1.002

Copyright © 2012 Wolters Kluwer Health, Inc.

More Verdeso resources

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

Compare Verdeso with other medications

• Atopic Dermatitis
• Dermatitis
• Eczema
• Psoriasis

PBZ

Generic Name: tripelennamine (tri pel EH na meen)

Brand Names: PBZ, PBZ-SR

What is PBZ (tripelennamine)?

Tripelennamine is an antihistamine. Tripelennamine blocks the effects of the naturally occurring chemical histamine in the body.

Tripelennamine is used to treat sneezing; runny nose; itching, watery eyes; hives; rashes; itching; and other symptoms of allergies and the common cold.

Tripelennamine may also be used for purposes other than those listed in this medication guide.

What is the most important information I should know about PBZ (tripelennamine)?

Use caution when driving, operating machinery, or performing other hazardous activities. Tripelennamine may cause dizziness or drowsiness. If you experience dizziness or drowsiness, avoid these activities. Use alcohol cautiously. Alcohol may increase drowsiness and dizziness while taking tripelennamine. Do not crush, chew, or break the sustained-release forms of tripelennamine. Swallow them whole. They are specially formulated to release slowly in the body.

What should I discuss with my healthcare provider before taking PBZ (tripelennamine)?

Do not take tripelennamine if you have taken a monoamine oxidase inhibitor (MAOI) such as isocarboxazid (Marplan), phenelzine (Nardil), or tranylcypromine (Parnate) in the last 14 days. A dangerous drug interaction could occur, leading to serious side effects.

Before taking this medication, tell your doctor if you have

• 
  

  glaucoma or increased pressure in the eye;

  
  


• 
  

  a stomach ulcer;

  
  


• 
  

  an enlarged prostate, bladder problems, or difficulty urinating;

  
  


• 
  

  an overactive thyroid (hyperthyroidism);

  
  


• 
  

  high blood pressure or any type of heart problem; or

  
  


• 
  

  asthma.

  
  

You may not be able to take tripelennamine, or you may require a dosage adjustment or special monitoring during treatment if you have any of the conditions listed above.

It is not known whether tripelennamine will be harmful to an unborn baby. Do not take tripelennamine without first talking to your doctor if you are pregnant. Tripelennamine may be harmful to a nursing baby. Do not take tripelennamine without first talking to your doctor if you are breast-feeding. If you are over 60 years of age, you may be more likely to experience side effects from tripelennamine. You may require a lower dose of this medication.

How should I take PBZ (tripelennamine)?

Take tripelennamine exactly as directed by your doctor. If you do not understand these directions, ask your pharmacist, nurse, or doctor to explain them to you.

Take each dose with a full glass of water. Tripelennamine can be taken with food to lessen stomach upset. Do not crush, chew, or break the sustained-release forms of tripelennamine. Swallow them whole. They are specially formulated to release slowly in the body.

To ensure that you get a correct dose, measure the elixir form of tripelennamine with a special dose-measuring spoon or cup, not with a regular table spoon. If you do not have a dose-measuring device, ask your pharmacist where you can get one.

Never take more of this medication than is prescribed for you. The regular-release tablets can be taken up to six times per day (every 4 hours) to a maximum of 600 mg for adults. The sustained-release tablets can be taken two or three times per day (every 8 to 12 hours) to a maximum of 300 mg for adults.

Store tripelennamine at room temperature away from moisture and heat.

What happens if I miss a dose?

Take the missed dose as soon as you remember. However, if it is almost time for the next dose, skip the missed dose and take only the next regularly scheduled dose. Do not take a double dose of this medication unless otherwise directed by your doctor.

What happens if I overdose?

Seek emergency medical attention.

Symptoms of a tripelennamine overdose include extreme sleepiness, confusion, weakness, ringing in the ears, blurred vision, large pupils, dry mouth, flushing, fever, shaking, insomnia, hallucinations, and possibly seizures.

What should I avoid while taking PBZ (tripelennamine)?

Use caution when driving, operating machinery, or performing other hazardous activities. Tripelennamine may cause dizziness or drowsiness. If you experience dizziness or drowsiness, avoid these activities. Use alcohol cautiously. Alcohol may increase drowsiness and dizziness while taking tripelennamine.

Tripelennamine may increase the effects of other drugs that cause drowsiness, including antidepressants, alcohol, antihistamines, pain relievers, anxiety medicines, seizure medicines, and muscle relaxants. Dangerous sedation, dizziness, or drowsiness may occur if tripelennamine is taken with any of these medications.

PBZ (tripelennamine) side effects

Stop taking tripelennamine and seek emergency medical attention if you experience an allergic reaction (difficulty breathing; closing of the throat; swelling of the lips, tongue, or face; or hives).

Other, less serious side effects may be more likely to occur. Continue to take tripelennamine and talk to your doctor if you experience

• 
  

  sleepiness, fatigue, or dizziness;

  
  


• 
  

  headache;

  
  


• 
  

  dry mouth; or

  
  


• 
  

  difficulty urinating or an enlarged prostate.

  
  

Side effects other than those listed here may also occur. Talk to your doctor about any side effect that seems unusual or that is especially bothersome. You may report side effects to FDA at 1-800-FDA-1088.

What other drugs will affect PBZ (tripelennamine)?

Do not take tripelennamine if you have taken a monoamine oxidase inhibitor (MAOI) such as isocarboxazid (Marplan), phenelzine (Nardil), or tranylcypromine (Parnate) in the last 14 days. A dangerous drug interaction could occur, leading to serious side effects.

Tripelennamine may increase the effects of other drugs that cause drowsiness, including antidepressants, alcohol, antihistamines, pain relievers, anxiety medicines, seizure medicines, and muscle relaxants. Dangerous sedation, dizziness, or drowsiness may occur if tripelennamine is taken with any of these medications.

Drugs other than those listed here may also interact with tripelennamine. Talk to your doctor and pharmacist before taking any prescription or over-the-counter medicines, including herbal products.

More PBZ resources

• Drug Images
• PBZ Drug Interactions
• 0 Reviews for PBZ - Add your own review/rating

Compare PBZ with other medications

• Conjunctivitis, Allergic
• Eye Dryness/Redness
• Eye Redness/Itching
• Hay Fever
• Rhinorrhea
• Upper Respiratory Tract Infection
• Urticaria

Where can I get more information?

• Your pharmacist has more information about tripelennamine written for health professionals that you may read.

Esocor P

Generic Name: chlorpheniramine, dextromethorphan, and pseudoephedrine (klor feh NEER a meen, dex tro meh THOR fan, and soo doe eh FEH drin)

Brand Names: AccuHist PDX Drops, Atuss DS, Children's NyQuil, Creomulsion Cough/Cold/Allergy, Creomulsion Pediatric, Dicel DM, Dicel DM Chewables, Entre-S, Esocor P, Kidcare Cough and Cold, M-End DM, Mesehist DM, Neutrahist PDX Drops, Nyquil Child Cough and Cold, Pediatric Cough & Cold Medicine, Rescon-DM, Robitussin Pediatric Night Relief, Robitussin PM Cough & Cold, Triaminic Cold and Cough, Triaminic Multi-Sympton, Triaminic Night Time, Triaminic Softchew Cold and Cough, Triaminic-D Multi-Symptom Cold, Vicks 44M Pediatric, Vicks Pediatric Formula 44M

What is Esocor P (chlorpheniramine, dextromethorphan, and pseudoephedrine)?

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

Dextromethorphan is a cough suppressant. It affects the signals in the brain that trigger cough reflex.

Pseudoephedrine is a decongestant that shrinks blood vessels in the nasal passages. Dilated blood vessels can cause nasal congestion (stuffy nose).

The combination of chlorpheniramine, dextromethorphan, and pseudoephedrine is used to treat runny or stuffy nose, sneezing, itching, watery eyes, cough, and sinus congestion caused by allergies, the common cold, or the flu.

Dextromethorphan will not treat a cough that is caused by smoking, asthma, or emphysema.

Chlorpheniramine, dextromethorphan, and pseudoephedrine may also be used for purposes not listed in this medication guide.

What is the most important information I should know about Esocor P (chlorpheniramine, dextromethorphan, and pseudoephedrine)?

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 use a cough or cold medicine if you have used an MAO inhibitor such as furazolidone (Furoxone), isocarboxazid (Marplan), phenelzine (Nardil), rasagiline (Azilect), selegiline (Eldepryl, Emsam, Zelapar), or tranylcypromine (Parnate) in the last 14 days. A dangerous drug interaction could occur, leading to serious side effects.

Ask a doctor or pharmacist before taking this medicine if you have heart disease, high blood pressure, kidney disease, diabetes, glaucoma, a thyroid disorder, emphysema or bronchitis, an enlarged prostate, or urination problems.

Do not use cold or cough medicine without your doctor's advice if you are pregnant or breast-feeding. Ask a doctor or pharmacist before using any other cold, cough, or allergy medicine. Chlorpheniramine, dextromethorphan, and pseudoephedrine are contained in many combination medicines. Taking certain products together can cause you to get too much of a certain drug. Check the label to see if a medicine contains an antihistamine, cough suppressant, or decongestant. Do not take this medicine for longer than 7 days in a row. Talk with your doctor if your symptoms do not improve after 7 days of treatment, or if you have a fever with a headache, cough, or skin rash.

What should I discuss with my healthcare provider before taking Esocor P (chlorpheniramine, dextromethorphan, and pseudoephedrine)?

Do not use a cough or cold medicine if you have used an MAO inhibitor such as furazolidone (Furoxone), isocarboxazid (Marplan), phenelzine (Nardil), rasagiline (Azilect), selegiline (Eldepryl, Emsam, Zelapar), or tranylcypromine (Parnate) in the last 14 days. A dangerous drug interaction could occur, leading to serious side effects.

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

• 
  

  heart disease or high blood pressure;

  
  


• 
  

  kidney disease;

  
  


• 
  

  diabetes;

  
  


• 
  

  glaucoma;

  
  


• 
  

  a thyroid disorder;

  
  


• 
  

  emphysema or chronic bronchitis;

  
  


• 
  

  an enlarged prostate; or

  
  


• 
  

  problems with urination.

  
  

FDA pregnancy category C. It is not known whether chlorpheniramine, dextromethorphan, and pseudoephedrine will harm an unborn baby. Do not use this medication without medical advice if you are pregnant. Chlorpheniramine, dextromethorphan, and pseudoephedrine may pass into breast milk and may harm a nursing baby. Do not use cold or cough medicine without medical advice if you are breast-feeding a baby.

Artificially sweetened liquid cough or cold medicine may contain phenylalanine. If you have phenylketonuria (PKU), check the medication label to see if the product contains phenylalanine.

How should I take Esocor P (chlorpheniramine, dextromethorphan, and pseudoephedrine)?

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. Cough or cold medicine is usually taken only for a short time until your symptoms clear up.

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.

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.

The chewable tablet should be chewed before you swallow it.

Shake the oral suspension well just before you measure a dose. Do not take this medicine for longer than 7 days in a row. Talk with your doctor if your symptoms do not improve after 7 days of treatment, or if you have a fever with a headache, cough, or skin rash.

This medication can cause unusual results with allergy skin tests. Tell any doctor who treats you that you are taking an antihistamine.

If you need surgery, tell the surgeon ahead of time if you have taken a cough or cold medicine within the past few days. Store at room temperature away from moisture and heat.

What happens if I miss a dose?

Since cough or cold 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.

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

What should I avoid while taking Esocor P (chlorpheniramine, dextromethorphan, and pseudoephedrine)?

This medication may cause blurred vision and may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be alert and able to see clearly.

Avoid becoming overheated or dehydrated during exercise and in hot weather. Chlorpheniramine can decrease sweating and you may be more prone to heat stroke.

Drinking alcohol can increase certain side effects of this medication.

Avoid taking this medication if you also take diet pills, caffeine pills, or other stimulants (such as ADHD medications). Taking a stimulant together with a decongestant can increase your risk of unpleasant side effects.

Ask a doctor or pharmacist before using any other cold, cough, or allergy medicine. Chlorpheniramine, dextromethorphan, and pseudoephedrine are contained in many combination medicines. Taking certain products together can cause you to get too much of a certain drug. Check the label to see if a medicine contains an antihistamine, cough suppressant, or decongestant.

Esocor P (chlorpheniramine, dextromethorphan, and pseudoephedrine) 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. Stop using this medicine and call your doctor at once if you have a serious side effect such as:

• 
  

  fast, pounding, or uneven heartbeats;

  
  


• 
  

  slow, shallow breathing;

  
  


• 
  

  confusion, hallucinations, unusual thoughts or behavior;

  
  


• 
  

  severe dizziness, anxiety, restless feeling, or nervousness;

  
  


• 
  

  urinating less than usual or not at all;

  
  


• 
  

  easy bruising or bleeding, unusual weakness, fever, chills, body aches, flu symptoms; or

  
  


• 
  

  dangerously high blood pressure (severe headache, blurred vision, buzzing in your ears, anxiety, confusion, chest pain, shortness of breath, uneven heartbeats, seizure).

  
  

Less serious side effects may include:

• 
  

  dry mouth, nose, or throat;

  
  


• 
  

  mild stomach pain, constipation;

  
  


• 
  

  blurred vision;

  
  


• 
  

  dizziness, drowsiness, mild headache;

  
  


• 
  

  sleep problems (insomnia);

  
  


• 
  

  feeling restless or excited (especially in children);

  
  


• 
  

  problems with memory or concentration; or

  
  


• 
  

  flushing (warmth, redness, or tingly feeling).

  
  

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 Esocor P (chlorpheniramine, dextromethorphan, and pseudoephedrine)?

Before using this medicine, tell your doctor if you regularly use other medicines that make you sleepy (such as sedatives, narcotic pain medicine, sleeping pills, muscle relaxers, and medicine for seizures, depression, or anxiety). They can add to sleepiness caused by chlorpheniramine, dextromethorphan, and pseudoephedrine.

Ask a doctor or pharmacist if it is safe for you to use chlorpheniramine, dextromethorphan, and pseudoephedrine if you are also using any of the following drugs:

• 
  

  glycopyrrolate (Robinul);

  
  


• 
  

  mepenzolate (Cantil);

  
  


• 
  

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

  
  


• 
  

  bladder or urinary medications such as darifenacin (Enablex), flavoxate (Urispas), oxybutynin (Ditropan, Oxytrol), tolterodine (Detrol), or solifenacin (Vesicare);

  
  


• 
  

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

  
  


• 
  

  a diuretic (water pill), or blood pressure medicine;

  
  


• 
  

  irritable bowel medications such as dicyclomine (Bentyl), hyoscyamine (Hyomax), or propantheline (Pro Banthine); or

  
  


• 
  

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

  
  

This list is not complete and other drugs may interact with chlorpheniramine, dextromethorphan, and pseudoephedrine. 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 Esocor P resources

• Esocor P Side Effects (in more detail)
• Esocor P Use in Pregnancy & Breastfeeding
• Esocor P Drug Interactions
• 0 Reviews for Esocor P - Add your own review/rating

• AccuHist PDX Drops MedFacts Consumer Leaflet (Wolters Kluwer)


• AccuHist PDX Drops Prescribing Information (FDA)


• Dicel DM Chewables Chewable Tablets MedFacts Consumer Leaflet (Wolters Kluwer)


• Entre-S Prescribing Information (FDA)

Compare Esocor P with other medications

• Cough and Nasal Congestion

Where can I get more information?

• Your pharmacist can provide more information about chlorpheniramine, dextromethorphan, and pseudoephedrine.

See also: Esocor P side effects (in more detail)

Thytropar

Generic Name: thyrotropin (Injection route)

thye-roe-TROE-pin

Commonly used brand name(s)

In the U.S.

• Thyrogen

In Canada

• Thytropar

Available Dosage Forms:

• Powder for Solution

Therapeutic Class: Diagnostic Agent, Thyroid Function

Pharmacologic Class: Pituitary Hormone, Anterior

Uses For Thytropar

Thyrotropin is used in a test to determine how well your thyroid is working. It may also be used for other conditions as determined by your doctor.

Thyrotropin is to be administered only by or under the immediate supervision of your doctor.

Before Using Thytropar

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine 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

This medicine has been tested in children and has not been shown to cause different side effects or problems than it does in adults.

Geriatric

Many medicines have not been studied specifically in the elderly. Therefore, it may not be known whether they work exactly the same way they do in younger adults. Although there is no specific information comparing the use of thyrotropin in the elderly with use in other age groups, this medicine is not expected to cause different side effects or problems in older people than it does in younger adults.

Pregnancy

	Pregnancy Category	Explanation
All Trimesters	C	Animal studies have shown an adverse effect and there are no adequate studies in pregnant women OR no animal studies have been conducted and there are no adequate studies in pregnant women.

Breast Feeding

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

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. Tell your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.

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 this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

• Hardening of the arteries or


• Heart disease or


• High blood pressure—Thyrotropin increases body metabolism and causes the heart to work harder, which may make these conditions worse

• Untreated underactive adrenal gland or


• Untreated underactive pituitary gland—Use of thyrotropin may severely worsen these conditions

Proper Use of thyrotropin

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

For your doctor to properly treat your medical condition, you must receive every dose of this medicine. After the last dose, the doctor may want to perform certain tests that are very important.

It is important that your doctor check your progress to make sure that this medicine is working properly and to check for unwanted effects.

Dosing

The dose of this medicine 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 this medicine. 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 injection dosage form:
  
  • For testing the thyroid gland:
    
    • Adults and children—10 International Units (IU) injected under the skin or into a muscle once a day for one to three days. If thyroid testing is being done after surgery, this medicine will usually be given for three to seven days.
    
    
  
  

Thytropar 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.

Check with your doctor immediately if any of the following side effects occur:

Rare - more common in patients who have received thyrotropin previously

• Faintness


• itching, redness, or swelling at place of injection


• skin rash


• tightness of throat


• wheezing

Symptoms of overdose

• Chest pain


• fast or irregular heartbeat


• irritability


• nervousness


• shortness of breath


• sweating

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

• Flushing of face


• frequent urge to urinate


• headache


• nausea and vomiting


• stomach discomfort

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.

See also: Thytropar side effects (in more detail)

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.

More Thytropar resources

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

Compare Thytropar with other medications

• Diagnosis and Investigation
• Thyroid Cancer

Sulfacetamide/Urea Emulsion

Pronunciation: sul-fa-SEE-ta-mide/yoor-EE-a
Generic Name: Sulfacetamide/Urea
Brand Name: Examples include Rosula Cleanser and Sulfatol Cleanser

Sulfacetamide/Urea Emulsion is used for:

Treating certain skin conditions (eg, seborrheic dermatitis), dandruff, and certain bacterial infections of the skin. It may also be used for other conditions as determined by your doctor.

Sulfacetamide/Urea Emulsion is a sulfonamide antibiotic. It works by killing bacteria, helping to shed scaly skin, and softening the skin.

Do NOT use Sulfacetamide/Urea Emulsion if:

• you are allergic to any ingredient in Sulfacetamide/Urea Emulsion


• you have had a severe allergic reaction (eg, severe rash, hives, difficulty breathing, dizziness) to any other sulfonamide medicine, such as acetazolamide, celecoxib, certain diuretics (eg, hydrochlorothiazide), glyburide, probenecid, sulfamethoxazole, valdecoxib, or zonisamide


• you are taking methenamine

Contact your doctor or health care provider right away if any of these apply to you.

Before using Sulfacetamide/Urea Emulsion:

Some medical conditions may interact with Sulfacetamide/Urea Emulsion. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

• if you are pregnant, planning to become pregnant, or are breast-feeding


• if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement


• if you have allergies to medicines, foods, or other substances


• if you have a history of lupus

Some MEDICINES MAY INTERACT with Sulfacetamide/Urea Emulsion. Tell your health care provider if you are taking any other medicines, especially any of the following:

• Silver-containing products (eg, silver sulfadiazine) because they may decrease Sulfacetamide/Urea Emulsion's effectiveness


• Methenamine because it may increase the risk of Sulfacetamide/Urea Emulsion's side effects

This may not be a complete list of all interactions that may occur. Ask your health care provider if Sulfacetamide/Urea Emulsion may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use Sulfacetamide/Urea Emulsion:

Use Sulfacetamide/Urea Emulsion as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• Sulfacetamide/Urea Emulsion is for use on the skin only. Wash your hands before and immediately after using Sulfacetamide/Urea Emulsion. Clean the affected area before applying Sulfacetamide/Urea Emulsion. Wet skin and apply plenty of Sulfacetamide/Urea Emulsion. Rub gently into the skin for 10 to 20 seconds to form a full lather, rinse completely, and pat dry.


• To clear up your infection completely, use Sulfacetamide/Urea Emulsion for the full course of treatment. Keep using it even if you feel better in a few days.


• Sulfacetamide/Urea Emulsion works best if it is used at the same time each day.


• Continue to use Sulfacetamide/Urea Emulsion even if you feel well. Do not miss any doses.


• If you miss a dose of Sulfacetamide/Urea Emulsion, use it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not use 2 doses at once.

Ask your health care provider any questions you may have about how to use Sulfacetamide/Urea Emulsion.

Important safety information:

• It may take several days for Sulfacetamide/Urea Emulsion to work fully.


• Avoid getting Sulfacetamide/Urea Emulsion in your eyes, nose, or mouth.


• Talk with your doctor before you use any other medicines or cleansers on your skin.


• Contact your doctor right away if stomach pain or cramps, severe diarrhea, or bloody stools occur. Do not treat diarrhea without first checking with your doctor.


• Sulfacetamide/Urea Emulsion only works against bacteria; it does not treat viral infections.


• Be sure to use Sulfacetamide/Urea Emulsion for the full course of treatment. If you do not, the medicine may not clear up your infection completely. The bacteria could also become less sensitive to this or other medicines. This could make the infection harder to treat in the future.


• Long-term or repeated use of Sulfacetamide/Urea Emulsion may cause a second infection. Tell your doctor if signs of a second infection occur. Your medicine may need to be changed to treat this.


• Sulfacetamide/Urea Emulsion should be used with extreme caution in CHILDREN younger than 12 years old; safety and effectiveness in these children have not been confirmed.


• PREGNANCY and BREAST-FEEDING: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Sulfacetamide/Urea Emulsion while you are pregnant. It is not known if Sulfacetamide/Urea Emulsion is found in breast milk after topical use. If you are or will be breast-feeding while you use Sulfacetamide/Urea Emulsion, check with your doctor. Discuss any possible risks to your baby.

Possible side effects of Sulfacetamide/Urea Emulsion:

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Irritation, stinging, or burning of the skin.

Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); bloody diarrhea; fever; joint pain; red, swollen, or blistered skin; severe diarrhea; sores in the mouth; stomach cramps/pain.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately. Sulfacetamide/Urea Emulsion may be harmful if swallowed. Symptoms of ingestion may include change in the amount of urine; nausea; vomiting.

Proper storage of Sulfacetamide/Urea Emulsion:

Store Sulfacetamide/Urea Emulsion at room temperature, between 68 and 77 degrees F (20 and 25 degrees C). Store away from heat, moisture, and light. Do not store in the bathroom. Do not freeze. Keep Sulfacetamide/Urea Emulsion out of the reach of children and away from pets.

General information:

• If you have any questions about Sulfacetamide/Urea Emulsion, please talk with your doctor, pharmacist, or other health care provider.


• Sulfacetamide/Urea Emulsion is to be used only by the patient for whom it is prescribed. Do not share it with other people.


• If your symptoms do not improve or if they become worse, check with your doctor.


• Check with your pharmacist about how to dispose of unused medicine.

This information is a summary only. It does not contain all information about Sulfacetamide/Urea Emulsion. If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.

Issue Date: February 1, 2012

Database Edition 12.1.1.002

Copyright © 2012 Wolters Kluwer Health, Inc.

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