Flavoxate

Dosage Form: tablet
Flavoxate Hydrochloride Tablets 100 mg, Film-Coated

Rx only

Flavoxate Description

Flavoxate hydrochloride tablets contain Flavoxate hydrochloride, a synthetic urinary tract spasmolytic.

Chemically, Flavoxate hydrochloride is 2-piperidinoethyl 3-methyl-4-oxo-2-phenyl-4H-1-benzopyran-8-carboxylate hydrochloride. The empirical formula of Flavoxate hydrochloride is C24H25NO4•HCl. The molecular weight is 427.94. The structural formula appears below.

Figure 1

Each tablet for oral administration contains 100 mg Flavoxate hydrochloride. In addition, each tablet contains the following inactive ingredients: colloidal silicon dioxide, corn starch, dibasic calcium phosphate dihydrate, hypromellose, polydextrose, magnesium stearate, titanium dioxide and triacetin.

Flavoxate - Clinical Pharmacology

Flavoxate hydrochloride counteracts smooth muscle spasm of the urinary tract and exerts its effect directly on the muscle.

In a single study of 11 normal male subjects, the time to onset of action was 55 minutes. The peak effect was observed at 112 minutes. 57% of the Flavoxate hydrochloride was excreted in the urine within 24 hours.

Indications and Usage for Flavoxate

Flavoxate hydrochloride tablets are indicated for symptomatic relief of dysuria, urgency, nocturia, suprapubic pain, frequency and incontinence as may occur in cystitis, prostatitis, urethritis, urethrocystitis/urethrotrigonitis. Flavoxate hydrochloride tablets are not indicated for definitive treatment, but are compatible with drugs used for the treatment of urinary tract infections.

Contraindications

Flavoxate hydrochloride is contraindicated in patients who have any of the following obstructive conditions: pyloric or duodenal obstruction, obstructive intestinal lesions or ileus, achalasia, gastrointestinal hemorrhage and obstructive uropathies of the lower urinary tract.

Warnings

Flavoxate hydrochloride should be given cautiously in patients with suspected glaucoma.

Precautions

Information for Patients

Patients should be informed that if drowsiness and blurred vision occur, they should not operate a motor vehicle or machinery or participate in activities where alertness is required.

Carcinogenesis, Mutagenesis, Impairment of Fertility

Mutagenicity studies and long-term studies in animals to determine the carcinogenic potential of Flavoxate hydrochloride have not been performed.

Pregnancy

Teratogenic Effects-Pregnancy Category B.

Reproduction studies have been performed in rats and rabbits at doses up to 34 times the human dose and revealed no evidence of impaired fertility or harm to the fetus due to Flavoxate hydrochloride. There are, however, no well-controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed.

Nursing Mothers

It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when Flavoxate hydrochloride is administered to a nursing woman.

Pediatric Use

Safety and effectiveness in children below the age of 12 years have not been established.

Adverse Reactions

The following adverse reactions have been observed, but there are not enough data to support an estimate of their frequency.

Gastrointestinal: Nausea, vomiting, dry mouth.

CNS: Vertigo, headache, mental confusion, especially in the elderly, drowsiness, nervousness.

Hematologic: Leukopenia (one case which was reversible upon discontinuation of the drug).

Cardiovascular: Tachycardia and palpitation.

Allergic: Urticaria and other dermatoses, eosinophilia and hyperpyrexia.

Ophthalmic: Increased ocular tension, blurred vision, disturbance in eye accommodation.

Renal: Dysuria.

Overdosage

The oral LD50 for Flavoxate hydrochloride in rats is 4273 mg/kg. The oral LD50 for Flavoxate hydrochloride in mice is 1837 mg/kg.

It is not known whether Flavoxate hydrochloride is dialyzable.

Flavoxate Dosage and Administration

Adults and children over 12 years of age

One or two 100 mg tablets 3 or 4 times a day. With improvement of symptoms, the dose may be reduced. This drug cannot be recommended for infants and children under 12 years of age because safety and efficacy have not been demonstrated in this age group.

How is Flavoxate Supplied

Flavoxate hydrochloride 100 mg tablets are available as white, round biconvex, film-coated tablets, debossed “Є 58” on one side and plain on the other side, and are available in bottles of 100 and 1000.

Store at 20° - 25°C (68° - 77°F) [see USP Controlled Room Temperature]. Dispense contents in a tight, light-resistant container.

Manufactured by

Epic Pharma, LLC

Laurelton, NY 11413

Made in USA

Issued 01/11

MF058IS01/11

OE1140

PACKAGE/LABEL PRINCIPAL DISPLAY PANEL

Flavoxate HYDROCHLORIDE  Flavoxate hydrochloride  tablet

Product Information Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 42806-058 Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Flavoxate HYDROCHLORIDE (Flavoxate) Flavoxate 100 mg

Inactive Ingredients Ingredient Name Strength DIBASIC CALCIUM PHOSPHATE DIHYDRATE   STARCH, CORN   SILICON DIOXIDE   MAGNESIUM STEARATE   TITANIUM DIOXIDE   POLYDEXTROSE   HYPROMELLOSE PHTHALATE (24% PHTHALATE, 55 CST)   TRIACETIN

Product Characteristics Color WHITE Score no score Shape ROUND Size 11mm Flavor Imprint Code E58 Contains

Packaging # NDC Package Description Multilevel Packaging 1 42806-058-01 100 TABLET In 1 BOTTLE None 2 42806-058-10 1000 TABLET In 1 BOTTLE None

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA076835	02/21/2011

Labeler - Epic Pharma, LLC (827915443)

Registrant - Epic Pharma, LLC (827915443)

Establishment
Name	Address	ID/FEI	Operations
Epic Pharma, LLC		827915443	MANUFACTURE

Revised: 06/2011Epic Pharma, LLC

More Flavoxate resources

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

• Flavoxate Professional Patient Advice (Wolters Kluwer)


• Flavoxate MedFacts Consumer Leaflet (Wolters Kluwer)


• Flavoxate Hydrochloride Monograph (AHFS DI)


• flavoxate Advanced Consumer (Micromedex) - Includes Dosage Information


• flavoxate Concise Consumer Information (Cerner Multum)

Compare Flavoxate with other medications

• Dysuria
• Overactive Bladder
• Urinary Incontinence

FluMist

Generic Name: influenza virus vaccine, live (Nasal route)

n-floo-EN-za VYE-rus VAX-een, lyve

Commonly used brand name(s)

In the U.S.

• FluMist

Available Dosage Forms:

• Solution

Therapeutic Class: Vaccine

Uses For FluMist

Influenza virus vaccine is used to prevent infection by the influenza viruses. The vaccine works by causing your body to produce its own protection (antibodies) against the disease.

There are many kinds of influenza viruses, but not all will cause problems in any given year. Therefore, before the influenza vaccine is produced each year, the World Health Organization (WHO) and the U.S. and Canadian Public Health Services decide which viruses will most likely cause influenza infections for that year. The antigens, which are substances that cause protective antibodies to be formed, for these viruses are included in the influenza vaccine. Usually, the U.S. and Canada use the same influenza vaccine; however, they are not required to do so.

It is necessary to receive an influenza vaccine each year, since influenza infections are usually caused by different kinds of viruses and the protection gained by the vaccine lasts less than a year.

Influenza is a virus infection of the throat, bronchial tubes, and lungs. Influenza infection causes fever, chills, cough, headache, muscle aches, and pains in your back, arms, and legs. In addition, adults and children weakened by other diseases or medical conditions, and persons 50 years of age and over, even if they are healthy, may get a much more serious illness that may have to be treated in a hospital. Each year thousands of people die as a result of an influenza infection.

The best way to help prevent influenza infections is to get an influenza vaccination each year, usually in early November. Immunization (getting a vaccine) against influenza is approved for infants 6 months of age and over, all children, and all adults.

This vaccine is to be administered only by or under the supervision of your doctor or other health care professional.

Before Using FluMist

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

Appropriate studies performed to date have not demonstrated pediatric-specific problems that would limit the usefulness of nasal influenza virus vaccine in children 2 years of age and older. However, this vaccine is not indicated for children younger than 2 years of age.

Children younger than 5 years of age with one or more episodes of wheezing in the past year should not receive this vaccine.

Geriatric

Appropriate studies have not been performed on the relationship of age to the effects of nasal influenza virus vaccine in adults 50 years of age and older. Safety and efficacy have not been established.

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

Studies in women suggest that this medication poses minimal risk to the infant when used during 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. When you are receiving this vaccine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Receiving this vaccine with any of the following medicines is not recommended. Your doctor may decide not to use this vaccine or change some of the other medicines you take.

• Aspirin

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

• Aclarubicin


• Adalimumab


• Aldesleukin


• Altretamine


• Amonafide


• Amsacrine


• Asparaginase


• Azacitidine


• Azathioprine


• Bleomycin


• Broxuridine


• Busulfan


• Capecitabine


• Carboplatin


• Carmustine


• Certolizumab Pegol


• Chlorambucil


• Cisplatin


• Cladribine


• Cyclophosphamide


• Cytarabine


• Cytarabine Liposome


• Dacarbazine


• Dactinomycin


• Daunorubicin


• Daunorubicin Citrate Liposome


• Decitabine


• Docetaxel


• Doxifluridine


• Doxorubicin Hydrochloride


• Doxorubicin Hydrochloride Liposome


• Edatrexate


• Eflornithine


• Epirubicin


• Estramustine


• Etanercept


• Etoposide


• Everolimus


• Fingolimod


• Floxuridine


• Fludarabine


• Fluorouracil


• Fotemustine


• Gallium Nitrate


• Gemcitabine


• Golimumab


• Hydroxyurea


• Idarubicin


• Ifosfamide


• Irinotecan


• Lomustine


• Mechlorethamine


• Melphalan


• Mercaptopurine


• Methotrexate


• Mitolactol


• Mitomycin


• Mitotane


• Mitoxantrone


• Mycophenolic Acid


• Oxaliplatin


• Paclitaxel


• Pegaspargase


• Pentostatin


• Pipobroman


• Pirarubicin


• Plicamycin


• Procarbazine


• Raltitrexed


• Rilonacept


• Rituximab


• Sirolimus


• Streptozocin


• Teceleukin


• Tegafur


• Temsirolimus


• Teniposide


• Thioguanine


• Thiotepa


• Topotecan


• Treosulfan


• Trimetrexate


• Trofosfamide


• Uracil Mustard


• Ustekinumab


• Vinblastine


• Vincristine


• Vincristine Liposome


• Vindesine


• Vinorelbine


• Warfarin

Receiving this vaccine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Abatacept


• Carbamazepine


• Leflunomide


• Vaccinia Immune Globulin, Human

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

• Allergy to eggs, egg products, gentamicin, gelatin, or arginine (an amino acid), history of—Should not be used in patients with these conditions.

• Asthma, severe or


• Diabetes or


• Heart disease or


• Kidney disease or


• Lung disease or


• Wheezing, history of—Use with caution. May make these conditions worse.

• Guillain-Barré syndrome (GBS, a severe nerve and muscle problem), history of—Use with caution. May cause the symptoms of this condition to return.

• Immune system problems (e.g., cancer, HIV)—This vaccine may not work as well if you have weak immune system.

• Severe illness with fever—Should not be given when a fever is present. Your doctor will decide when you are well enough to get your influenza virus vaccine.

Proper Use of FluMist

A nurse or other trained health professional will give you or your child this vaccine. This vaccine is given as a nasal spray.

Use the nasal spray only in the nose. Do not get any of it in your eyes or on your skin. If it does get on these areas, rinse it off right away.

Before using the nasal spray, gently blow your nose to clear the nostrils.

Children 2 to 8 years of age who have not received the nasal vaccine before should receive 2 doses at least 1 month apart.

This vaccine comes with a patient information insert. It is very important that you read and understand this information. Be sure to ask your doctor about anything you do not understand.

Precautions While Using FluMist

It is very important that your child return to your doctor's office at the right time for the second dose. Be sure to notify your doctor of any side effects that occur after you receive this vaccine.

This vaccine should not be given to children and teenagers (2 to 17 years of age) who are also using aspirin or any medicine that contains aspirin (e.g., Aggrenox®, Ecotrin®, Excedrin®, Soma® Compound, and many cold medicines). Also, children and teenagers should not be given aspirin for 4 weeks after getting FluMist® unless your doctor tells you otherwise.

Children younger than 2 years of age are usually not given the flu vaccine nasal spray. Young children who need the flu vaccine are usually given the flu vaccine injection (a shot).

This vaccine may cause a serious type of allergic reaction called anaphylaxis. Anaphylaxis can be life-threatening and requires immediate medical attention. Tell your doctor right away if you or your child have a rash, itching, swelling of the tongue and throat, or trouble breathing after you receive the vaccine.

The nasal mist vaccine (FluMist®) contains a live virus. Avoid contact with people who are sick or at increased risk of getting the infection after you or your child receive this vaccine. Talk to your doctor about this if you have concerns.

Influenza virus vaccine will not treat flu symptoms if you already have the virus. Also, this vaccine may not protect all persons given the vaccine.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

FluMist Side Effects

In 1976, a number of people who received the “swine flu” influenza vaccine developed Guillain-Barré syndrome (GBS), which is a disease that may cause paralysis. Most of these people were over 25 years of age. Although only 10 out of every one million people who received the vaccine actually developed GBS, this number was 6 times higher than would normally have been expected. Most of the people who got GBS recovered completely.

It is assumed that the “swine flu” virus included in the 1976 vaccine caused the problem, but this has not been proven. Since that time, the “swine flu” virus has not been used in influenza vaccines, and there has been no recurrence of GBS that was associated with influenza vaccinations.

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 or nurse immediately if any of the following side effects occur:

More common

• Chills


• cough


• decreased appetite


• fever


• headache


• muscle aches


• sore throat


• stuffy or runny nose


• tiredness or weakness

Less common

• Earache


• pain or tenderness around the eyes and cheekbones


• redness or swelling in the ear


• shortness of breath or troubled breathing


• sneezing


• tightness of the chest or wheezing

Rare

• Difficulty with breathing or swallowing


• hives


• itching, especially of the feet or hands


• reddening of the skin, especially around the ears


• swelling of the eyes, face, or inside of the nose


• unusual tiredness or weakness (sudden and severe)

Incidence not known

• Anxiety


• bloody nose


• blue or pale skin


• chest pain, possibly moving to the left arm, neck, or shoulder


• confusion


• diarrhea


• dizziness


• drowsiness


• fast heartbeat


• general feeling of illness


• hoarseness


• inability to move the arms and legs


• irritation


• itching


• joint pain, stiffness, or swelling


• nausea


• puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue


• severe headache


• skin rash


• stiff neck and/or back


• sudden numbness and weakness in the arms and legs


• swelling or puffiness of the face


• unusual drowsiness, dullness, tiredness, weakness, or feeling of sluggishness


• unusual tiredness or weakness


• vomiting


• weakness of the muscles in your face

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

More common

• Abdominal or stomach pain


• irritability


• loss of appetite

Incidence not known

• Welts

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: FluMist 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 FluMist resources

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

• FluMist MedFacts Consumer Leaflet (Wolters Kluwer)


• FluMist Monograph (AHFS DI)


• Flumist Consumer Overview


• Flumist Prescribing Information (FDA)


• Influenza Virus Vaccine Inactivated Monograph (AHFS DI)

Compare FluMist with other medications

• Influenza Prophylaxis

Fluocinolone Shampoo

Pronunciation: floo-oh-SIN-oh-lone
Generic Name: Fluocinolone
Brand Name: Capex

Fluocinolone Shampoo is used for:

Treating seborrheic dermatitis (itching, redness, irritation, and flaking) of the scalp. It may also be used for other conditions as determined by your doctor.

Fluocinolone Shampoo is a topical corticosteroid. Exactly how it works is unknown.

Do NOT use Fluocinolone Shampoo if:

• you are allergic to any ingredient in Fluocinolone Shampoo

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

Before using Fluocinolone Shampoo:

Some medical conditions may interact with Fluocinolone Shampoo. 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 measles, chickenpox, or tuberculosis


• if you have hardening or thinning of the skin or a skin infection


• if you have recently been vaccinated or you have had a positive tuberculin skin test

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

Ask your health care provider if Fluocinolone Shampoo 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 Fluocinolone Shampoo:

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

• Fluocinolone Shampoo is for external use only.


• Shake well before each use.


• Rinse hair and scalp completely with water. Apply no more than 1 ounce of Fluocinolone Shampoo to the scalp area daily unless otherwise directed by your doctor. Lather and allow the medicine to remain on the scalp for 5 minutes, and then completely rinse hair and scalp twice.


• Do not bandage or wrap the affected area unless directed otherwise by your doctor.


• If you miss a dose of Fluocinolone Shampoo, 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 Fluocinolone Shampoo.

Important safety information:

• Avoid contact with eyes. In case of contact, wash eyes liberally with water.


• Fluocinolone Shampoo 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 if you are not sure, check with your doctor or pharmacist.


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


• Do not use Fluocinolone Shampoo for any conditions other than the one for which it was prescribed.


• Talk with your doctor before you receive any vaccine while you are using Fluocinolone Shampoo.


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


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

Possible side effects of Fluocinolone Shampoo:

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:

Dryness; itching.

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; excessive hair growth; inflamed hair follicles; inflammation around the mouth; irritation, burning, redness, or swelling not present before using Fluocinolone Shampoo; 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.

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 increased thirst or urination; muscle weakness; unusual weight gain, especially in the face.

Proper storage of Fluocinolone Shampoo:

Store Fluocinolone Shampoo at room temperature, between 59 and 86 degrees F (15 and 30 degrees C). Store away from heat, moisture, and light. Throw away any unused medicine after 3 months. Do not store in the bathroom. Keep Fluocinolone Shampoo out of the reach of children and away from pets.

General information:

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


• Fluocinolone Shampoo 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 Fluocinolone Shampoo. 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 Fluocinolone resources

• Fluocinolone Use in Pregnancy & Breastfeeding
• Fluocinolone Drug Interactions
• Fluocinolone Support Group
• 3 Reviews for Fluocinolone - Add your own review/rating

Compare Fluocinolone with other medications

• Atopic Dermatitis
• Dermatitis
• Lichen Sclerosus

Flebogamma DIF

Pronunciation: i-MUNE GLOB-ue-lin
Generic Name: Immune Globulin (Human)
Brand Name: Examples include Flebogamma DIF, Gamunex, and Privigen

Flebogamma DIF may increase the risk of serious and sometimes fatal kidney problems. The risk may be greater if you already have kidney problems. The risk may also be greater if you have diabetes, dehydration or low blood volume, a blood infection, or abnormal proteins in the blood. You may also be at increased risk if you are older than 65 years or if you take another medicine that may harm your kidneys. Contact your doctor right away if you experience decreased urination, lower back or flank pain, swelling or bloating, sudden weight gain, shortness of breath, or weakness.

Flebogamma DIF is used for:

Providing antibodies to help prevent infection in certain patients who have a weakened immune system. It may also be used for other conditions as determined by your doctor.

Flebogamma DIF is an immune globulin. It works to prevent infection by providing antibodies that fight infection.

Do NOT use Flebogamma DIF if:

• you are allergic to any ingredient in Flebogamma DIF or to immune globulin (human)


• you have had a severe allergic reaction (eg, severe rash, hives, difficulty breathing, dizziness) to blood or products that are produced from blood


• you have immunoglobulin A (IgA) deficiency, unless your doctor tells you otherwise

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

Before using Flebogamma DIF:

Some medical conditions may interact with Flebogamma DIF. 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 high levels of proline in your blood (hyperprolinemia)


• if you have recently received any vaccinations or will be receiving a live vaccine (eg, measles, mumps)


• if you have heart problems, blood vessel problems (eg, narrowed arteries), bleeding or blood clotting problems, thick blood, or a history of a stroke, a heart attack, or blood clots


• if you will be confined to a bed or chair for a long period of time


• if you have kidney problems, diabetes, dehydration or low blood volume, a blood infection, a weakened immune system, abnormal proteins or high protein levels in the blood, or asthma


• if you have a history of migraine headaches

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

• Medicines that may harm the kidney (eg, aminoglycoside antibiotics [eg, gentamicin], amphotericin B, cyclosporine, nonsteroidal anti-inflammatory drugs [NSAIDs] [eg, ibuprofen], tacrolimus, vancomycin) because the risk of kidney side effects may be increased. Ask your doctor if you are unsure if any of your medicines might harm the kidney


• Hydantoins (eg, phenytoin) because unexpected hypersensitivity reactions may occur


• Live vaccines (eg, measles, mumps, and rubella) because their effectiveness may be decreased by Flebogamma DIF

This may not be a complete list of all interactions that may occur. Ask your health care provider if Flebogamma DIF 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 Flebogamma DIF:

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

• Flebogamma DIF is usually given as an injection at your doctor's office, hospital, or clinic.


• Do not use Flebogamma DIF if it contains particles, is cloudy or discolored, or if the vial is cracked or damaged.


• Do not use Flebogamma DIF if it has ever been frozen.


• Keep this product, as well as syringes and needles, out of the reach of children and pets. Do not reuse needles, syringes, or other materials. Ask your health care provider how to dispose of these materials after use. Follow all local rules for disposal.


• If you miss a dose of Flebogamma DIF, contact your doctor right away.

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

Important safety information:

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


• Patients who receive some of these medicines for the first time, who switch from another brand of immune globulin, or who have not received immune globulin therapy within the past 8 weeks may have a risk of developing fever, chills, nausea, or vomiting. Tell your doctor right away if you experience any of these side effects.


• Aseptic meningitis syndrome (AMS) has been reported to occur rarely in association with the use of Flebogamma DIF. This usually begins within several hours to 2 days following treatment. Symptoms include severe headache, neck stiffness, unusual drowsiness, fever, painful eye movements, sensitivity to light, nausea, and vomiting.


• You may need to wait for a period of time after you use Flebogamma DIF before you receive a live vaccine (eg, measles, mumps). Talk with your doctor before you receive any vaccine.


• Flebogamma DIF is made from human plasma. There is an extremely low risk of developing a viral infection (eg, parvovirus, hepatitis A) or Creutzfeldt-Jakob disease (CJD) after using Flebogamma DIF. Discuss any questions or concerns with your doctor.


• Flebogamma DIF may interfere with certain lab tests. Be sure your doctor and lab personnel know you are using Flebogamma DIF.


• Lab tests, including kidney function, blood thickness, and antibody levels, may be performed while you use Flebogamma DIF. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.


• Use Flebogamma DIF with caution in the ELDERLY; they may be more sensitive to its effects, especially kidney problems and blood clots.


• Use Flebogamma DIF with extreme caution in CHILDREN; safety and effectiveness of certain products have not been established for certain age groups. Check with your doctor or pharmacist if you have questions about the use of Flebogamma DIF in a child.


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

Possible side effects of Flebogamma DIF:

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:

Back pain; chills; cough; diarrhea; dizziness; ear pain; fatigue; flushing; headache; muscle cramps; nausea; pain, swelling, muscle stiffness, or redness at the injection site; sore throat; stuffy nose; weakness.

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

Severe allergic reactions (rash; itching; hives; difficulty breathing or swallowing; tightness in the chest; swelling of the mouth, hands, face, lips, eyes, throat, or tongue; unusual hoarseness); blue lips, hands, or feet; calf or leg pain, tenderness, or swelling; chest pain or tightness; confusion; coughing up blood; eye pain or sensitivity to light; fainting; fast or irregular heartbeat; fever; increased or painful urination; numbness of an arm or a leg; one-sided weakness; red, swollen, blistered, or peeling skin; seizures; severe headache, dizziness, or stomach pain; shortness of breath or trouble breathing; speech problems; symptoms of kidney problems (eg, decreased urination, lower back or flank pain, swelling or bloating, sudden weight gain); symptoms of liver problems (eg, yellowing of the skin or eyes, dark urine, pale stools, nausea, stomach pain, loss of appetite, unusual tiredness); symptoms of parvovirus infection (eg, fever, drowsiness, chills, runny nose, rash, joint pain); unusual bruising or bleeding; vision problems; wheezing.

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 Flebogamma DIF:

Flebogamma DIF is usually handled and stored by a health care provider. If you are using Flebogamma DIF at home, store Flebogamma DIF as directed by your pharmacist or health care provider. Keep Flebogamma DIF out of the reach of children and away from pets.

General information:

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


• Flebogamma DIF 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 Flebogamma DIF. 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 Flebogamma DIF resources

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

Compare Flebogamma DIF with other medications

• Autoimmune Neutropenia
• Bone Marrow Transplantation
• Chronic Inflammatory Demyelinating Polyradiculoneuropathy
• Chronic Lymphocytic Leukemia
• Evan's Syndrome
• HIV Infection
• Idiopathic Thrombocytopenic Purpura
• Kawasaki Disease
• Myasthenia Gravis
• Polymyositis/Dermatomyositis
• Primary Immunodeficiency Syndrome

Flagyl I.V. RTU

Generic Name: metronidazole (Oral route)

met-roe-NYE-da-zole

Oral route(Tablet;Tablet, Extended Release;Capsule)

Metronidazole has been shown to be carcinogenic in mice and rats. Unnecessary use of the drug should be avoided. Its use should be reserved only for conditions for which it is approved .

Commonly used brand name(s)

In the U.S.

• Flagyl


• Flagyl ER

Available Dosage Forms:

• Tablet, Extended Release


• Capsule


• Tablet


• Suspension

Therapeutic Class: Antibiotic

Chemical Class: Nitroimidazole

Uses For Flagyl I.V. RTU

Metronidazole is used to treat bacterial infections in different areas of the body. The extended-release tablets are used to treat women with vaginal infections (bacterial vaginosis).

Metronidazole belongs to the class of medicines known as antibiotics. It works by killing bacteria or preventing their growth. However, this medicine will not work for colds, flu, or other virus infections.

This medicine is available only with your doctor's prescription.

Once a medicine has been approved for marketing for a certain use, experience may show that it is also useful for other medical problems. Although these uses are not included in product labeling, metronidazole is used in certain patients with the following medical conditions:

• Clostridium difficile diarrhea or colitis (antibiotic-associated colitis).


• Crohn's disease (inflammatory bowel disease).


• Gastritis or stomach ulcers due to Helicobacter pylori.


• Giardiasis (parasite infection in the intestines).

Before Using Flagyl I.V. RTU

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

Appropriate studies have not been performed on the relationship of age to the effects of metronidazole to treat bacterial infections in the pediatric population. Safety and efficacy have not been established.

Appropriate studies performed to date have not demonstrated pediatric-specific problems that would limit the usefulness of metronidazole in children with amebiasis.

Geriatric

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of metronidazole in the elderly. However, elderly patients are more likely to have age-related liver problems, which may require caution and an adjustment in the dose for patients receiving metronidazole.

Pregnancy

	Pregnancy Category	Explanation
All Trimesters	B	Animal studies have revealed no evidence of harm to the fetus, however, there are no adequate studies in pregnant women OR animal studies have shown an adverse effect, but adequate studies in pregnant women have failed to demonstrate a risk to the fetus.

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. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

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

• Amprenavir


• Disulfiram

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

• Amiodarone


• Busulfan


• Fluorouracil


• Mycophenolate Mofetil


• Warfarin

Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Carbamazepine


• Cholestyramine


• Cyclosporine


• Lithium


• Milk Thistle


• Tacrolimus

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. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following is not recommended. Your doctor may decide not to treat you with this medication, change some of the other medicines you take, or give you special instructions about the use of food, alcohol, or tobacco.

• Ethanol

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:

• Leukopenia (low white blood cells), history of or


• Optic neuropathy (eye disease with vision changes), history of or


• Oral thrush (Candida infection) or


• Peripheral neuropathy (nerve disease with pain, numbness, or tingling), history of or


• Seizures, history of or


• Vaginal yeast infection (Candida infection)—Use with caution. May make these conditions worse.

• Liver disease, severe—Use with caution. The effects may be increased because of slower removal of the medicine from the body.

Proper Use of metronidazole

This section provides information on the proper use of a number of products that contain metronidazole. It may not be specific to Flagyl I.V. RTU. Please read with care.

Take this medicine only as directed by your doctor. Do not take more of it, do not take it more often, and do not take it for a longer time than your doctor ordered.

The regular tablet or capsule can be taken with or without food. If the medicine upsets your stomach, it is best to take it with a meal or snack.

The extended–release tablet must be taken without food, one hour before or two hours after a meal.

Swallow the extended-release tablet whole. Do not break, crush, or chew it.

To help clear up your infection completely, keep using this medicine for the full time of treatment, even if you begin to feel better after a few days. If you stop using this medicine too soon, your infection may return.

This medicine works best when there is a constant amount in the blood. To help keep the amount constant, do not miss any doses. Also, it is best to take the doses at evenly spaced times during the day. If you need help planning the best times to take your medicine, check with your doctor.

If you have taken a medicine called disulfiram (Antabuse®) within the last 2 weeks, do not take metronidazole until you talk to your doctor. Disulfiram is used to help people who have a drinking problem. If these 2 medicines are taken close together, serious unwanted effects may occur.

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 oral dosage forms (capsules or tablets):
  
  • For amebiasis infections:
    
    • Adults and teenagers—500 or 750 milligrams (mg) 3 times per day for 5 to 10 days.
    
    
    • Children—Dose is based on body weight and must be determined by your doctor. The dose is usually 35 to 50 milligrams (mg) per kilogram (kg) of body weight per day, divided and given in 3 doses, for 10 days.
    
    
  
  
  • For bacterial infections:
    
    • Adults and teenagers—Dose is based on body weight and must be determined by your doctor. The dose is usually 7.5 milligrams (mg) per kilogram (kg) of body weight, up to a maximum dose of 1 gram, every 6 hours for 7 to 10 days.
    
    
    • Children—Use and dose must be determined by your doctor.
    
    
  
  
  • For trichomoniasis infections:
    
    • Adults and teenagers—The tablet can be given 3 different ways: as a single dose of 2 grams; or as 1 gram 2 times per day for 1 day; or as 250 milligrams (mg) 3 times per day for 7 days. The capsule dose is 375 mg 2 times per day for 7 days.
    
    
    • Children—Use and dose must be determined by your doctor.
    
    
  
  


• For oral dosage form (extended-release tablets):
  
  • For bacterial vaginosis:
    
    • Adults and teenagers—750 milligrams (mg) once a day for 7 days.
    
    
    • Children—Use and dose must be determined by your doctor.
    
    
  
  

Missed Dose

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

Storage

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

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Precautions While Using Flagyl I.V. RTU

It is important that your doctor check your progress after you finish taking this medicine. This is to make sure that the infection is cleared up. Blood tests may be needed to check for unwanted effects.

If your symptoms do not improve within a few days after you start this medicine or if they become worse, check with your doctor.

Drinking alcoholic beverages while using this medicine may cause stomach pain, nausea, vomiting, headache, or flushing or redness of the face. Other alcohol-containing preparations (e.g., elixirs, cough syrups, tonics) may also cause problems. These problems may last for at least one day after you stop using metronidazole. This medicine may also cause alcoholic beverages to taste different. You should not drink alcoholic beverages or take other alcohol-containing preparations while you are using this medicine and for at least 3 days after stopping it.

Using this medicine while you are pregnant (especially during the first 3 months of pregnancy) can harm your unborn baby. Use an effective form of birth control to keep from getting pregnant. If you think you have become pregnant while using the medicine, tell your doctor right away.

If you are using this medicine for trichomoniasis (an infection of the sex organs in men or women), your doctor may want to treat your sexual partner at the same time you are being treated, even if he or she has no symptoms. Also, it may be desirable to use a condom (rubber) during sexual intercourse. These measures will help to keep you from getting the infection back again from your partner. If you have any questions about this, check with your doctor.

Check with your doctor right away if you are having burning, numbness, tingling, or painful sensations in the arms, hands, legs, or feet. These could be symptoms of a condition called peripheral neuropathy.

Check with your doctor right away if you have dizziness, problems with muscle control or coordination, shakiness or an unsteady walk, slurred speech, or trouble with speaking. These may be symptoms of a serious brain condition called encephalopathy.

Call your doctor right away if you have confusion, drowsiness, fever, a general feeling of illness, a headache, loss of appetite, nausea, a stiff neck or back, or vomiting. These could be symptoms of a serious condition called aseptic meningitis.

Metronidazole may cause dry mouth, an unpleasant or sharp metallic taste, and a change in taste sensation. For temporary relief of dry mouth, use sugarless candy or gum, melt bits of ice in your mouth, or use a saliva substitute. If your mouth continues to feel dry for more than 2 weeks, check with your medical doctor or dentist. Continuing dryness of the mouth may increase the chance of dental disease, including tooth decay, gum disease, and fungus infections.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

Flagyl I.V. RTU 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:

More common

• Agitation


• back pain


• blindness


• blurred vision


• burning, numbness, tingling, or painful sensations in the hands or feet


• changes in speech patterns


• confusion


• convulsions


• decreased vision


• depression


• dizziness


• drowsiness


• eye pain


• fever


• hallucinations


• headache


• irritability


• lack of coordination


• mood or mental changes


• nausea


• seizures


• shakiness and unsteady walk


• slurred speech


• stiff neck or back


• trouble with speaking


• unsteadiness, trembling, or other problems with muscle control or coordination


• unusual tiredness or weakness


• vomiting


• weakness in the arms, hands, legs, or feet

Less common

• Black, tarry stools


• blood in the urine or stools


• body aches or pain


• chills


• clumsiness or unsteadiness


• difficulty with breathing


• ear congestion


• feeling of pelvic pressure


• frequent or painful urination


• loss of voice


• nasal congestion


• pinpoint red spots on the skin


• runny nose


• skin rash, hives, redness, or itching


• sneezing


• stomach and back pain (severe)


• unusual bleeding or bruising


• vaginal irritation, discharge, or dryness not present before taking the medicine

Rare

• Bleeding gums


• bloating


• chest pain


• constipation


• cough


• dark-colored urine


• fast heartbeat


• indigestion


• loss of appetite


• painful or difficult urination


• pains in the stomach, side, or abdomen, possibly radiating to the back


• shortness of breath


• sore throat


• sores, ulcers, or white spots on the lips or in the mouth


• swollen glands


• yellow eyes or skin

Incidence not known

• Blistering, peeling, or loosening of the skin


• bloody or cloudy urine


• burning while urinating


• continuing diarrhea


• continuing stomach pain


• diarrhea


• feeling of warmth


• increased volume of pale, dilute urine


• joint or muscle pain


• loss of bladder control


• red irritated eyes


• red skin lesions, often with a purple center


• redness of the face, neck, arms, and occasionally, upper chest


• redness of the skin

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

More common

• Abdominal or stomach cramps


• dizziness or lightheadedness


• feeling of constant movement of self or surroundings


• heartburn


• sensation of spinning


• sleeplessness


• trouble sleeping


• unable to sleep


• weight loss

Less common or rare

• Change in taste sensation


• congestion


• dry mouth


• pain or tenderness around the eyes and cheekbones


• stuffy nose


• tender, swollen glands in the neck


• trouble with swallowing


• unpleasant or sharp metallic taste


• voice changes

Incidence not known

• Decreased interest in sexual intercourse


• inability to have or keep an erection


• loss in sexual ability, desire, drive, or performance


• painful sexual intercourse

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

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

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

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

More Flagyl I.V. RTU resources

• Flagyl I.V. RTU Use in Pregnancy & Breastfeeding
• Drug Images
• Flagyl I.V. RTU Drug Interactions
• Flagyl I.V. RTU Support Group
• 107 Reviews for Flagyl I.V. RTU - Add your own review/rating

• Flagyl Prescribing Information (FDA)


• Flagyl Consumer Overview


• Flagyl Monograph (AHFS DI)


• Flagyl MedFacts Consumer Leaflet (Wolters Kluwer)


• Flagyl ER Extended-Release Tablets MedFacts Consumer Leaflet (Wolters Kluwer)


• Flagyl ER Prescribing Information (FDA)


• Metronidazole Prescribing Information (FDA)


• Metronidazole Professional Patient Advice (Wolters Kluwer)


• Metronidazole MedFacts Consumer Leaflet (Wolters Kluwer)

Compare Flagyl I.V. RTU with other medications

• Amebiasis
• Aspiration Pneumonia
• Bacteremia
• Bacterial Infection
• Bacterial Vaginitis
• Bone infection
• Clostridial Infection
• Crohn's Disease, Acute
• Crohn's Disease, Maintenance
• Deep Neck Infection
• Dental Abscess
• Diverticulitis
• Dracunculiasis
• Endocarditis
• Giardiasis
• Helicobacter Pylori Infection
• Intraabdominal Infection
• Joint Infection
• Meningitis
• Pelvic Inflammatory Disease
• Peritonitis
• Pneumonia
• Pseudomembranous Colitis
• Skin Infection
• Surgical Prophylaxis
• Trichomoniasis

Pipethanen

Pipethanen may be available in the countries listed below.

Ingredient matches for Pipethanen

Piroxicam

Piroxicam is reported as an ingredient of Pipethanen in the following countries:

• Japan

International Drug Name Search

factor IX complex

Generic Name: factor IX complex (FAK tor NINE KOM plex)

Brand names: Bebulin VH, Konyne 80, Profilnine SD, Proplex T, Mononine (obsolete1), Alphanine SD (obsolete1), AlphaNine SD (obsolete)

What is factor IX complex?

Factor IX (nine) is a naturally occurring protein in the blood that helps blood to clot. A lack of clotting factors can cause uncontrolled bleeding, as the blood is unable to clot properly.

Factor IX complex is a combination of four different clotting factors and other proteins. This medication works by temporarily raising levels of these clotting factors in the blood to aid in clotting.

Factor IX complex is used to treat or prevent bleeding episodes in people with hemophilia B. It is also used to control bleeding related to surgery or dentistry in people with hemophilia B.

Factor IX may also be used for other purposes not listed in this medication guide.

What is the most important information I should know about factor IX complex?

Before using factor IX complex, your specific blood clotting disorder must be diagnosed as factor IX or factor VIII (eight) deficiency.

Your doctor may want you to receive a hepatitis vaccination before you start using factor IX complex.

Use this medication exactly as it was prescribed for you. Do not use the medication in larger amounts, or use it for longer than recommended by your doctor. Follow the instructions on your prescription label. Always check the strength of the medicine on the label to be sure you are using the correct potency.

Carry an ID card or wear a medical alert bracelet stating that you have hemophilia in case of emergency. Any doctor, dentist, or emergency medical care provider who treats you should know that you have a bleeding or blood-clotting disorder.

Factor IX complex is made from human plasma (part of the blood) and may contain viruses and other infectious agents that can cause disease. Although donated human plasma is screened, tested, and treated to reduce the risk of it containing anything that could cause disease, there is still a small possibility it could transmit disease. Talk with your doctor about the risks and benefits of using this medication.

What should I discuss with my healthcare provider before using factor IX complex?

Before using factor IX complex, your specific blood clotting disorder must be diagnosed as factor IX or factor VIII (eight) deficiency.

FDA pregnancy category C. This medication may be harmful to an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant during treatment. It is not known whether factor IX complex passes into breast milk or if it could harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby.

Factor IX complex is made from human plasma (part of the blood) and may contain viruses and other infectious agents that can cause disease. Although donated human plasma is screened, tested, and treated to reduce the risk of it containing anything that could cause disease, there is still a small possibility it could transmit disease. Talk with your doctor about the risks and benefits of using this medication.

Your doctor may want you to receive a hepatitis vaccination before you start using factor IX complex.

How should I use factor IX complex?

Use this medication exactly as it was prescribed for you. Do not use the medication in larger amounts, or use it for longer than recommended by your doctor. Follow the instructions on your prescription label. Always check the strength of the medicine on the label to be sure you are using the correct potency.

Factor IX complex is given as an injection through a needle placed into a vein. Your doctor, nurse, or other healthcare provider will give you this injection. You may be shown how to use your medicine at home. Do not self-inject this medicine if you do not fully understand how to give the injection and properly dispose of needles, IV tubing, and other items used in giving the medicine.

Always wash your hands before preparing and giving your injection.

Factor IX complex must be mixed with a liquid (diluent) before injecting it. If you store your medicine in the refrigerator, take a medicine and diluent vial out of the refrigerator and allow each to warm to room temperature before mixing them. Do not heat the medicine or diluent.

After mixing, gently swirl the mixture and allow the medicine to completely dissolve.

After mixing the medicine and diluent, the mixture should be kept at room temperature and must be used within 3 hours. Do not put mixed medicine into the refrigerator.

Draw your dose into a syringe only when you are ready to give yourself an injection. Each vial is for one use only. After measuring your dose, throw the vial away, even if there is medicine left in it.

Do not use this medication if it has changed colors or has any particles in it. Call your doctor for a new prescription.

Check your pulse before and during your injection. If your pulse rate changes, slow or stop the injection until your pulse rate returns to normal.

Use each disposable needle only one time. Throw away used needles in a puncture-proof container (ask your pharmacist where you can get one and how to dispose of it). Keep this container out of the reach of children and pets.

Carry an ID card or wear a medical alert bracelet stating that you have hemophilia in case of emergency. Any doctor, dentist, or emergency medical care provider who treats you should know that you have a bleeding or blood-clotting disorder. Store the medication and the diluent in the refrigerator and do not allow them to freeze.

Throw away any leftover medicine and diluent if the expiration date has passed.

What happens if I miss a dose?

Factor IX is sometimes used only as needed, so you may not be on a dosing schedule. If you are using the medication regularly, use the missed dose as soon as you remember. If it is almost time for your next dose, skip the missed dose and use the medicine at your next regularly scheduled time. Do not use extra medicine to make up the missed dose.

What happens if I overdose?

Call your doctor if you think you have used too much of this medicine. An overdose of factor IX complex is not expected to produce life-threatening symptoms.

What should I avoid while using factor IX complex?

Follow your doctor's instructions about any restrictions on food, beverages, or activity while you are using factor IX complex.

Factor IX complex side effects

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; nausea, vomiting; feeling light-headed, fainting; swelling of your face, lips, tongue, or throat. Stop using this medication and call your doctor at once if you have any of these serious side effects:

• 
  

  cough, chest pain;

  
  


• 
  

  weak or shallow breathing;

  
  


• 
  

  feeling short of breath;

  
  


• 
  

  headache, feeling like you might pass out;

  
  


• 
  

  fever, chills, drowsiness, and runny nose followed by skin rash and joint pain 2 weeks later;

  
  


• 
  

  nausea, stomach pain, low fever, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes);

  
  


• 
  

  easy bruising, increased bleeding episodes; or

  
  


• 
  

  bleeding from a wound or where the medicine was injected.

  
  

Less serious side effects may include:

• 
  

  mild nausea or stomach pain; or

  
  


• 
  

  mild tingly or jittery feeling.

  
  

This is not a complete list of side effects and others may occur. Tell your doctor about any unusual or bothersome side effect. You may report side effects to FDA at 1-800-FDA-1088.

Factor IX complex Dosing Information

Usual Adult Dose for Factor IX Deficiency:

Units required to raise blood level percentages: 1.0 unit/kg x body weight (in kg) x desired increase (% of normal).
In preparation for and following surgery, levels above 25%, maintained for at least a week after surgery, are suggested. Laboratory control to assure such levels is recommended. To maintain levels above 25% for a reasonable time, each dose should be calculated to raise the level to 40% to 60% of normal.

Usual Adult Dose for Hemophilia B:

Units required to raise blood level percentages: 1.0 unit/kg x body weight (in kg) x desired increase (% of normal).
In preparation for and following surgery, levels above 25%, maintained for at least a week after surgery, are suggested. Laboratory control to assure such levels is recommended. To maintain levels above 25% for a reasonable time, each dose should be calculated to raise the level to 40% to 60% of normal.

Usual Adult Dose for Factor VII Deficiency:

Proplex T (only):
Units required to raise blood level percentages: 0.5 unit/kg x body weight (in kg) x desired increase (% of normal). Repeat dose every 4 to 6 hours as needed.
In preparation for and following surgery, levels above 25%, maintained for at least a week after surgery, are suggested. Laboratory control to assure such levels is recommended. To maintain levels above 25% for a reasonable time, each dose should be calculated to raise the level to 40 to 60% of normal.

Usual Adult Dose for Hemophilia A with Inhibitors:

Proplex T (only):
Treatment of hemarthroses occurring in hemophiliacs with inhibitors to Factor VIII:
75 Factor IX units per kg of body weight.

What other drugs will affect factor IX complex?

There may be other drugs that can affect factor IX complex. Tell your doctor about all the prescription and over-the-counter medications you use. This includes vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start using a new medication without telling your doctor.

More factor IX complex resources

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

• Bebulin VH Prescribing Information (FDA)


• Bebulin VH MedFacts Consumer Leaflet (Wolters Kluwer)


• Profilnine SD Prescribing Information (FDA)


• factor ix complex Intravenous, Injection Advanced Consumer (Micromedex) - Includes Dosage Information

Compare factor IX complex with other medications

• Factor IX Deficiency
• Factor VII Deficiency
• Hemophilia A with Inhibitors
• Hemophilia B

Where can I get more information?

• Your doctor or pharmacist can provide more information about factor IX.

See also: factor IX complex side effects (in more detail)