Somavert

Pronunciation: peg-VI-soe-mant
Generic Name: Pegvisomant
Brand Name: Somavert

Somavert is used for:

Treating acromegaly in patients who have not responded to surgery, radiation therapy, or other medical procedures, or who are not candidates for those treatments.

Somavert is a growth hormone receptor antagonist. It works by blocking the site of action for growth hormone, which helps to block the effects of growth hormone.

Do NOT use Somavert if:

• you are allergic to any ingredient in Somavert, including polyethylene glycol


• you are allergic to latex

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

Before using Somavert:

Some medical conditions may interact with Somavert. 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 diabetes, a tumor or other growths, liver problems, or a history of alcohol abuse

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

• Narcotic pain medicine (eg, codeine) because it may decrease Somavert's effectiveness


• Insulin or oral hypoglycemic agents because the risk of their side effects may be increased by Somavert

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

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

• An extra patient leaflet is available with Somavert. Talk to your pharmacist if you have questions about this information.


• Somavert is usually given as an injection at your doctor's office, hospital, or clinic. If you will be using Somavert at home, a health care provider will teach you how to use it. Be sure you understand how to use Somavert. Follow the procedures you are taught when you use a dose. Contact your health care provider if you have any questions.


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


• Use the proper technique taught to you by your doctor. Inject deep under the skin, NOT into muscle.


• Somavert must be mixed before you use it. Follow your doctor's instructions on how to mix Somavert.


• Do not shake Somavert after mixing it. Hold the vial between the palms of both hands and gently roll it to dissolve the powder.


• Use Somavert within 6 hours after mixing it. Throw away any unused medicine left in the vial after your dose. If you do not use Somavert within 6 hours after you mix it, throw it away.


• Choose a different injection site each day (eg, upper arm, upper thigh, stomach area, buttocks) to help prevent lumps at the injection sites.


• 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 Somavert 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 Somavert.

Important safety information:

• Somavert may cause dizziness. This effect may be worse if you take it with alcohol or certain medicines. Use Somavert with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.


• Diabetes patients - Somavert may affect your blood sugar. Check blood sugar levels closely. Ask your doctor before you change the dose of your diabetes medicine.


• Somavert may interfere with certain lab tests, including some growth hormone level tests. Be sure your doctor and lab personnel know you are taking Somavert.


• Lab tests, including growth hormone blood levels, insulin-like growth factor blood levels, and liver function, may be performed while you use Somavert. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.


• Somavert should be used with extreme caution in CHILDREN; safety and effectiveness in 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 Somavert while you are pregnant. It is not known if Somavert is found in breast milk. If you are or will be breast-feeding while you use Somavert, check with your doctor. Discuss any possible risks to your baby.

Possible side effects of Somavert:

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; diarrhea; dizziness; flu-like symptoms (eg, mild fever or chills, muscle aches, weakness); nausea; pain, redness, or itching at the injection site; sinus inflammation.

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); chest pain; swelling of the legs and feet; symptoms of liver problems (eg, yellowing of the skin or eyes, dark urine, pale stools, unusual tiredness, severe or persistent nausea or stomach pain, loss of appetite); thickening of the skin or lumps at the injection site; unusual weight gain.

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: Somavert 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 increased fatigue.

Proper storage of Somavert:

Before mixing, store Somavert in the refrigerator between 36 and 46 degrees F (2 and 8 degrees C). Do not freeze. After mixing, Somavert may be kept at room temperature for up to 6 hours. Store away from heat, moisture, and light. Do not store in the bathroom. Keep Somavert out of the reach of children and away from pets.

General information:

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


• Somavert 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 Somavert. 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 Somavert resources

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

• Somavert Prescribing Information (FDA)


• Somavert Consumer Overview


• Somavert Monograph (AHFS DI)


• Somavert Advanced Consumer (Micromedex) - Includes Dosage Information


• Pegvisomant Professional Patient Advice (Wolters Kluwer)

Compare Somavert with other medications

• Acromegaly

Keppra Tablets

Pronunciation: LEE-va-tye-RA-se-tam
Generic Name: Levetiracetam
Brand Name: Keppra

Keppra is used for:

Treating partial-onset, myoclonic, or generalized tonic-clonic seizures in patients with epilepsy. It is used in combination with other medicines. It may also be used for other conditions as determined by your doctor.

Keppra is an anticonvulsant. Exactly how it works is not known, but it may work by slowing abnormal nerve impulses in the brain.

Do NOT use Keppra if:

• you are allergic to any ingredient in Keppra

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

Before using Keppra:

Tell your health care provider 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 kidney problems or you are on dialysis


• if you have a history of mental or mood problems (eg, depression), or suicidal thoughts or actions

Some MEDICINES MAY INTERACT with Keppra. However, no specific interactions with Keppra are known at this time.

Ask your health care provider if Keppra 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 Keppra:

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

• Keppra comes with an extra patient information sheet called a Medication Guide. Read it carefully. Read it again each time you get Keppra refilled.


• Take Keppra by mouth with or without food.


• Swallow Keppra whole. Do not break, crush, or chew before swallowing.


• Keppra works best if it is taken at the same time(s) each day.


• Continue to take Keppra even if you feel well. Do not miss any doses.


• If you miss a dose of Keppra, 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 Keppra.

Important safety information:

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


• Do not suddenly stop taking Keppra or your other seizure medicines. You may have an increased risk of side effects (eg, seizures). If you need to stop Keppra or add a new medicine, your doctor will gradually lower your dose.


• Contact your health care provider if your seizures become worse or if you have a new type of seizure.


• Patients who take Keppra may be at increased risk for suicidal thoughts or actions. The risk may be greater in patients who have had suicidal thoughts or actions in the past. Watch patients who take Keppra closely. Contact the doctor at once if new, worsened, or sudden symptoms such as depressed mood; anxious, restless, or irritable behavior; panic attacks; or any unusual changes in mood or behavior occur. Contact the doctor right away if any signs of suicidal thoughts or actions occur.


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


• Use Keppra with caution in the ELDERLY; they may be more sensitive to its effects.


• Keppra should be used with extreme caution in CHILDREN younger than 4 years old; safety and effectiveness in these children have not been confirmed.


• Caution is advised when using Keppra in CHILDREN; they may be more sensitive to its effects, especially weakness and mood or behavior changes.


• PREGNANCY and BREAST-FEEDING: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Keppra while you are pregnant. Keppra is found in breast milk. Do not breast-feed while taking Keppra.

Possible side effects of Keppra:

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:

Dizziness; drowsiness; irritability; runny nose; sore throat; tiredness; vomiting; weakness.

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); abnormal thoughts; dark urine; decreased coordination; extreme drowsiness, dizziness, tiredness, or weakness; fever, chills, or persistent sore throat; hallucinations; memory loss; mouth sores; new or worsening mental, mood, or behavior changes (eg, aggression, agitation, anger, anxiety, apathy, depression, hostility, irritability, panic attacks, restlessness); new or worsening seizures; suicidal thoughts or attempts; trouble sleeping; unusual bruising or bleeding; vision changes; yellowing of the skin or eyes.

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: Keppra 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 aggression; agitation; difficult or slow breathing; loss of consciousness; severe drowsiness.

Proper storage of Keppra:

Store Keppra at 77 degrees F (25 degrees C). Brief storage at temperatures between 59 and 86 degrees F (15 and 30 degrees C) is permitted. Store away from heat, moisture, and light. Do not store in the bathroom. Keep Keppra out of the reach of children and away from pets.

General information:

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


• Keppra 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 Keppra. 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 Keppra resources

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

Compare Keppra with other medications

• Bipolar Disorder
• Epilepsy
• Hyperekplexia
• Neuralgia
• New Daily Persistent Headache
• Seizures

Tygacil

Generic Name: tigecycline (Intravenous route)

tye-ge-SYE-kleen

Commonly used brand name(s)

In the U.S.

• Tygacil

Available Dosage Forms:

• Powder for Solution

Therapeutic Class: Antibiotic

Chemical Class: Glycylcycline

Uses For Tygacil

Tigecycline is an antibiotic. It is used to treat bacterial infections in many different parts of the body (e.g., infections on the skin, stomach, or lungs). 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.

Before Using Tygacil

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 tigecycline in the pediatric population. Safety and efficacy have not been established.

Geriatric

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of tigecycline in the elderly.

Pregnancy

	Pregnancy Category	Explanation
All Trimesters	D	Studies in pregnant women have demonstrated a risk to the fetus. However, the benefits of therapy in a life threatening situation or a serious disease, may outweigh the potential risk.

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 receiving 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 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.

• Warfarin

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:

• Diarrhea from an antibiotic or


• Liver disease or


• Pancreatitis (inflammation of the pancreas)—Use with caution. May make these conditions worse.

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

Proper Use of Tygacil

A nurse or other trained health professional will give you this medicine. This medicine is given through a needle placed in one of your veins. This medicine is given slowly, so the needle will remain in place for about 30 to 60 minutes.

Precautions While Using Tygacil

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

Using this medicine while you are pregnant 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.

Birth control pills may not work while you are using tigecycline. To keep from getting pregnant, use another form of birth control along with your birth control pills. Other forms include condoms, a diaphragm, or a contraceptive foam or jelly.

This medicine may cause serious allergic reactions, including anaphylaxis, which can be life-threatening and require immediate medical attention. Call your doctor right away if you have itching; hives; hoarseness; shortness of breath; trouble breathing; trouble swallowing; or any swelling of your hands, face, or mouth after you receive this medicine.

Tigecycline may cause diarrhea, and in some cases it can be severe. Do not take any medicine to treat diarrhea without first checking with your doctor. Diarrhea medicines may make the diarrhea worse or make it last longer. If you have any questions about this or if mild diarrhea continues or gets worse, check with your doctor.

Tigecycline may cause your skin to be more sensitive to sunlight than it is normally. Exposure to sunlight, even for brief periods of time, may cause a skin rash, itching, redness or other discoloration of the skin, or a severe sunburn. Use a sunscreen when you are outdoors. Wear protective clothing (including a hat) and sunglasses. Avoid sunlamps and tanning beds or booths.

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.

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

More common

• Cough or hoarseness


• dizziness


• fever or chills


• headache


• lower back or side pain


• pain, warmth, or burning in the fingers, toes, and legs


• painful or difficult urination


• problems with vision or hearing

Less common

• Abdominal or stomach pain


• accumulation of pus


• bloating or swelling of the face, arms, hands, lower legs, or feet


• bluish color


• blurred vision


• changes in skin color


• confusion


• convulsions


• decreased urine


• diarrhea


• difficult or labored breathing


• dizziness, faintness, or lightheadedness when getting up from a lying or sitting position suddenly


• dry mouth


• eye pain


• fat in the stool


• flushed, dry skin


• fruit-like breath odor


• general feeling of illness


• increased hunger


• increased thirst


• increased urination


• irregular heartbeat


• loss of appetite


• mood changes


• muscle pain or cramps


• nausea or vomiting


• nervousness


• numbness or tingling in the hands, feet, or lips


• pain


• pale skin


• pounding in the ears


• rapid weight gain


• shortness of breath


• slow or fast heartbeat


• sore throat


• sweating


• swollen, red, tender area of infection


• tenderness


• tightness in the chest


• troubled breathing with exertion


• unexplained weight loss


• unusual bleeding or bruising


• unusual tiredness or weakness


• unusual weight gain or loss


• wheezing

Rare

• Abdominal or stomach cramps


• anxiety


• black, tarry stools


• bleeding gums


• blood in the urine or stools


• chest pain or discomfort


• clay-colored stools


• cold sweats


• coma


• cool, pale skin


• dark urine


• depression


• difficulty in breathing


• itching


• muscle cramps in the hands, arms, feet, legs, or face


• nightmares


• pinpoint red spots on the skin


• rash


• shakiness


• slurred speech


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


• swelling of the face, ankles, or hands


• swollen glands


• tremor


• unpleasant breath odor


• vomiting of blood


• yellow eyes or skin

Incidence not known

• Bloating


• constipation


• difficulty in swallowing


• hives


• indigestion


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


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

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

• Red streaks on the skin


• swelling, tenderness, or pain at the injection site

Less common

• Acid or sour stomach


• belching


• heartburn


• lack or loss of strength


• sleeplessness


• stomach discomfort, upset, or pain


• trouble sleeping


• unable to sleep

Rare

• Bleeding, blistering, burning, coldness, discoloration of the skin, feeling of pressure, hives, infection, inflammation, itching, lumps, numbness, pain, rash, redness, scarring, soreness, stinging, swelling, tenderness, tingling, ulceration, or warmth at the injection site


• change in taste or bad unusual or unpleasant (after) taste


• increased clear or white vaginal discharge


• itching of the vagina or genital area


• pain during sexual intercourse


• sleepiness or unusual drowsiness


• thick, white vaginal discharge with no odor or with a mild odor


• vaginal yeast infection

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: Tygacil 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 Tygacil resources

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

• Tygacil Prescribing Information (FDA)


• Tygacil Consumer Overview


• Tygacil Monograph (AHFS DI)


• Tygacil MedFacts Consumer Leaflet (Wolters Kluwer)


• Tigecycline Professional Patient Advice (Wolters Kluwer)

Compare Tygacil with other medications

• Intraabdominal Infection
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• Skin and Structure Infection
• Skin Infection

Tetradure

Dosage Form: FOR ANIMAL USE ONLY
Tetradure™

300

(OXYTETRACYCLINE) INJECTION

ANTIBIOTIC

Each mL contains 300 mg of oxytetracycline base as amphoteric oxytetracycline.

For Use in Beef Cattle, Non-lactating Dairy Cattle, Calves, Including Pre-ruminating (Veal) Calves and Swine.

READ ENTIRE BROCHURE CAREFULLY BEFORE USING THIS PRODUCT.

Caution: Federal law restricts this drug to use by or on the order of a licensed veterinarian.

INTRODUCTION

Tetradure™ 300 (Oxytetracycline) Injection is a sterile, ready to use solution of the broad-spectrum antibiotic oxytetracycline dihydrate. Oxytetracycline is an antimicrobial agent that is effective in treatment of a wide range of diseases caused by susceptible gram-positive and gram-negative bacteria.

Tetradure™ 300 should be stored at room temperature 59°-86°F (15°-30°C). The antibiotic activity of oxytetracycline is not appreciably diminished in the presence of body fluids, serum or exudates.

INGREDIENTS

Tetradure™ 300 (oxytetracycline) Injection is a sterile, pre-constituted solution of the broad-spectrum antibiotic oxytetracycline dihydrate. Each mL contains 300 mg oxytetracycline as base, 40% (v/v) glycerol formal, 10% (v/v) polyethylene glycol 200, 2.7% (w/v) magnesium oxide, 0.4% (w/v) sodium formaldehyde sulphoxylate (as a preservative) and monoethanolamine (as required to adjust pH).

INDICATIONS

Tetradure™ 300 is intended for use in treatment for the following disease when due to oxytetracycline-susceptible organisms:

Beef cattle, non-lactating dairy cattle, calves, including pre-ruminating (veal) calves

Tetradure™ 300 is indicated in the treatment of pneumonia and shipping fever complex associated with Pasteurella spp., and Histophilus spp. Tetradure™ 300 is indicated for the treatment of the infectious bovine keratoconjunctivitis (pink eye) caused by Moraxella bovis, foot-rot and diphtheria caused by Fusobacterium necrophorum; bacterial enteritis (scours) caused by Escherichia coli; wooden tongue caused by Actinobacillus lignieresi; leptospirosis caused by Leptospira pomona; and wound infections and acute metritis caused by strains of staphylococcal and streptococcal organisms sensitive to oxytetracycline. Also, it is indicated for the control of respiratory disease in cattle at high risk of developing BRD associated with Mannheimia (Pasteurella) haemolytica.

Swine

Tetradure™ 300 is indicated in the treatment of bacterial enteritis (scours, colibacillosis) caused by Escherichia coli; pneumonia caused by Pasteurella multocida; and leptospirosis caused by Leptospira pomona.

In sows Tetradure™ 300 is indicated as an aid in control of infectious enteritis (baby pig scours, colibacillosis) in suckling pigs caused by Escherichia coli.

PHARMACOLOGY

Oxytetracycline is derived from the metabolic activity of the actinomycete, Streptomyces rimosus. Oxytetracycline is an antimicrobial agent that is effective in the treatment of a wide range of diseases caused by susceptible gram-positive and gram-negative bacteria.

The antibiotic activity of oxytetracycline is not appreciably diminished in the presence of body fluids, serum or exudates.

Studies have shown that the half-life of oxytetracycline in blood following intramuscular treatment with Tetradure™ 300 at 5 mg per pound of bodyweight is approximately 23 hours in cattle and 18 hours in swine.

Studies have shown when Tetradure™ 300 is administered once intramuscularly to cattle or swine at 9 mg per pound of bodyweight, blood oxytetracycline concentration of greater than 0.2 mcg/mL have been observed for 3 to 4 days.

Studies have shown when Tetradure™ 300 is administered once intramuscularly or subcutaneously to cattle at 13.6 mg per pound of bodyweight, blood oxytetracycline concentration of greater than 0.2 mcg/mL have been observed for at least 7 to 8 days.

Tetradure Dosage and Administration

Beef cattle, non-lactating dairy cattle, calves, including pre-ruminating (veal) calves

A single intramuscular or subcutaneous dosage of 13.6 mg of oxytetracycline per pound of bodyweight, Tetradure™ 300 is recommended for the control of respiratory disease in cattle at high risk of developing BRD associated with Mannheimia (Pasteurella) haemolytica.

At a single intramuscular or subcutaneous dose range of 9 to 13.6 mg of oxytetracycline per pound of bodyweight, Tetradure™ 300 is recommended in the treatment of the following conditions:

(1)

Bacterial pneumonia caused by Pasteurella spp (shipping fever) in calves and yearlings where retreatment is impractical due to husbandry conditions, such as cattle on range, or where their repeated restraint is inadvisable.

(2)

Infectious bovine keratoconjunctivitis (pink eye) caused by Moraxella bovis.

For other indications Tetradure™ 300 is to be administered intramuscularly, subcutaneously or intravenously at a level of 3 to 5 mg of oxytetracycline per pound of bodyweight per day. In treatment of foot-rot and advanced cases of other indicated diseases, a dosage level of 5 mg per pound of bodyweight per day is recommended. Treatment should be continued 24 to 48 hours following remission of disease signs, however, not to exceed a total of four (4) consecutive days. If improvement is not noted within 24 to 48 hours of the beginning of treatment, diagnosis and therapy should be re-evaluated.

Do not administer intramuscularly in the neck of small calves due to lack of sufficient muscle mass.

Use extreme care when administering this product by intravenous injection. Perivascular injection or leakage from an intravenous injection may cause severe swelling at the injection site.

Swine

A single dosage of 9 mg of oxytetracycline per pound of bodyweight administered intramuscularly is recommended in the treatment of bacterial pneumonia caused by Pasteurella multocida in swine, where retreatment is impractical due to husbandry conditions or where repeated restraint is inadvisable.

Tetradure™ 300 can also be administered by intramuscular injection at a level of 3 to 5 mg of oxytetracycline per pound of bodyweight per day. Treatment should be continued 24 to 48 hours following remission of disease signs; however, not to exceed a total of four (4) consecutive days. If improvement is not noted within 24 to 48 hours of the beginning of treatment, diagnosis and therapy should be re-evaluated.

For sows, administer once intramuscularly 3 mg of oxytetracycline per pound of bodyweight approximately eight (8) hours before farrowing or immediately after completion of farrowing as an aid in the control of infectious enteritis in baby pigs.

For swine weighing 25 lbs of bodyweight and under, Tetradure™ 300 should be administered undiluted for treatment at 9 mg/lb but should be administered diluted for treatment at 3 or 5 mg/lb.

	9 mg dosage of undiluted Tetradure™ 300	3 or 5 mg/lb dosage volume of diluted Tetradure™ 300
Bodyweight	9 mg/lb	3 mg/lb	Dilution*	5 mg/lb
* To prepare dilutions, add one part of Tetradure™ 300 to three (3), five (5) or seven (7) parts of the sterile water, or 5% dextrose solution as indicated; the diluted product should be used immediately.
5 lb	0.15 mL	0.4 mL	37.5 mg/mL	0.7 mL
10 lb	0.30 mL	0.6 mL	50 mg/mL	1.0 mL
25 lb	0.75 mL	1.0 mL	75 mg/mL	1.7 mL

Precautions

Exceeding the highest recommended level of drug per pound of bodyweight per day, administering more than the recommended number of treatments, and/or exceeding 10 mL intramuscularly or subcutaneously per injection site in adult beef cattle and non-lactating dairy cattle and 5 mL intramuscularly per injection site in adult swine, may result in antibiotic residues beyond the withdrawal time.

Consult with your veterinarian prior to administering this product in order to determine to proper treatment required in the event of an adverse reaction. At the first sign of any adverse reaction, discontinue use of the product and seek the advice of your veterinarian. Some of the reactions may be attributable either to anaphylaxis (an allergic reaction) or to cardiovascular collapse of unknown cause.

Shortly after injection treated animals may have transient hemoglobinuria resulting in darkened urine.

As with all antibiotic preparations, use of this drug may result in overgrowth of non-susceptible organisms, including fungi. The absence of a favourable response following treatment, or the development of new signs or symptoms may suggest an overgrowth of non-susceptible organisms. If superinfections occur, the use of this product should be discontinued and appropriate specific therapy should be instituted.

Since bacteriostatic drugs may interfere with the bactericidal action of penicillin, it is advisable to avoid giving Tetradure™ 300 in conjunction with penicillin.

STORAGE

Store at room temperature, 59°-86°F (15°-30°C). Keep from freezing.

Warnings

WARNINGS: Discontinue treatment at least 28 days prior to slaughter of cattle and swine. Not for use in lactating dairy animals. Rapid intravenous administration may result in animal collapse. Oxytetracycline should be administered intravenous slowly over a period of at least 5 minutes.

The Material Safety Data Sheet (MSDS) contains more detailed occupational safety information. To report adverse effects, obtain an MSDS or for assistance, contact Merial at 1-888-637-4251.

CAUTION

Intramuscular or subcutaneous injection may result in local tissue reactions which persist beyond the slaughter withdrawal period. This may result in trim loss of edible tissue at slaughter.

Intramuscular injection in the rump area may cause mild temporary lameness associated with swelling at the injection site. Subcutaneous injection in the neck area may cause swelling at the injection site.

Adverse Reactions

Reports of adverse reactions associated with oxytetracycline administration include injection site swelling, restlessness, ataxia, trembling, swelling of eyelids, ears, muzzle, anus and vulva (or scrotum and sheath in males), respiratory abnormalities (labored breathing), frothing at the mouth, collapse and possibly death. Some of these reactions may be attributed either to anaphylaxis (an allergic reaction) or to cardiovascular collapse of unknown cause.

PRESENTATION

Tetradure™ 300 is available in 100 mL, 250 mL and 500 mL vials.

Livestock Drug - Not for Human Use.

Restricted Drug(s) California. Use Only as Directed.

DISTRIBUTED BY:

Merial Limited

Duluth, GA 30096-4640, USA

™Tetradure is a trademark and Cattle Head Logo is a registered trademark of Merial Limited.

MADE IN THE UK

U.S. Patent No. 6,110,905

U.S. Patent No. 6,310,053

Rev. 06-2003

008630109

NADA 141-143, APPROVED BY THE FDA

PRINCIPAL DISPLAY PANEL - 100 mL Carton

Tetradure™

300

(OXYTETRACYCLINE) INJECTION

ANTIBIOTIC

Each mL contains 300 mg of Oxytetracycline

base as amphoteric oxytetracycline.

For the treatment of diseases in beef cattle,

non-lactating dairy cattle, calves, including

pre-ruminating (veal) calves and swine.

Caution: Federal law restricts this drug to use

by or on the order of a licensed veterinarian.

NADA 141-143, Approved By FDA

U.S. Patent No. 6,110,905

U.S. Patent No. 6,310,053

Net Contents:

100 mL

MERIAL

Tetradure 300  oxytetracycline  injection, solution

Product Information Product Type PRESCRIPTION ANIMAL DRUG NDC Product Code (Source) 50604-0415 Route of Administration INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength oxytetracycline (oxytetracycline) oxytetracycline 300 mg  in 1 mL

Inactive Ingredients Ingredient Name Strength glycerol formal   polyethylene glycol   magnesium oxide   sodium formaldehyde sulfoxylate

Product Characteristics Color      Score      Shape Size Flavor Imprint Code Contains

Packaging # NDC Package Description Multilevel Packaging 1 50604-0415-1 1 BOTTLE In 1 CARTON contains a BOTTLE, GLASS 1 100 mL In 1 BOTTLE, GLASS This package is contained within the CARTON (50604-0415-1) 2 50604-0415-2 1 BOTTLE In 1 CARTON contains a BOTTLE, GLASS 2 250 mL In 1 BOTTLE, GLASS This package is contained within the CARTON (50604-0415-2) 3 50604-0415-3 1 BOTTLE In 1 CARTON contains a BOTTLE, GLASS 3 500 mL In 1 BOTTLE, GLASS This package is contained within the CARTON (50604-0415-3)

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
NADA	NADA141143	07/31/1993

Labeler - Merial Limited (034393582)

Revised: 09/2010Merial Limited

Sildenafil

Generic Name: sildenafil (oral) (sil DEN a fil)

Brand Names: Revatio, Viagra

What is sildenafil?

Sildenafil relaxes muscles and increases blood flow to particular areas of the body.

Sildenafil under the name Viagra is used to treat erectile dysfunction (impotence) in men. Another brand of sildenafil is Revatio, which is used to treat pulmonary arterial hypertension and improve exercise capacity in men and women.

Do not take Viagra while also taking Revatio, unless your doctor tells you to.

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

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

Do not take sildenafil if you are also using a nitrate drug for chest pain or heart problems. This includes nitroglycerin (Nitrostat, Nitrolingual, Nitro-Dur, Nitro-Bid, and others), isosorbide dinitrate (Dilatrate-SR, Isordil, Sorbitrate), and isosorbide mononitrate (Imdur, ISMO, Monoket). Nitrates are also found in some recreational drugs such as amyl nitrate or nitrite ("poppers"). Taking sildenafil with a nitrate medicine can cause a sudden and serious decrease in blood pressure. During sexual activity, if you become dizzy or nauseated, or have pain, numbness, or tingling in your chest, arms, neck, or jaw, stop and call your doctor right away. You could be having a serious side effect of sildenafil. Do not take sildenafil more than once a day. Allow 24 hours to pass between doses. Contact your doctor or seek emergency medical attention if your erection is painful or lasts longer than 4 hours. A prolonged erection (priapism) can damage the penis.

Sildenafil can decrease blood flow to the optic nerve of the eye, causing sudden vision loss. This has occurred in a small number of people taking sildenafil, most of whom also had heart disease, diabetes, high blood pressure, high cholesterol, or certain pre-existing eye problems, and in those who smoke or are over 50 years old. It is not clear whether sildenafil is the actual cause of vision loss.

Stop using sildenafil and get emergency medical help if you have sudden vision loss.

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

Do not take sildenafil if you are also using a nitrate drug for chest pain or heart problems. This includes nitroglycerin (Nitrostat, Nitrolingual, Nitro-Dur, Nitro-Bid, and others), isosorbide dinitrate (Dilatrate-SR, Isordil, Sorbitrate), and isosorbide mononitrate (Imdur, ISMO, Monoket). Nitrates are also found in some recreational drugs such as amyl nitrate or nitrite ("poppers"). Taking sildenafil with a nitrate medicine can cause a sudden and serious decrease in blood pressure.

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

• 
  

  heart disease or heart rhythm problems;

  
  


• 
  

  a recent history (in the past 6 months) of a heart attack, stroke, or congestive heart failure;

  
  


• 
  

  high or low blood pressure;

  
  


• 
  

  coronary artery disease;

  
  


• 
  

  liver or kidney disease;

  
  


• 
  

  a blood cell disorder such as sickle cell anemia, multiple myeloma, or leukemia;

  
  


• 
  

  a bleeding disorder such as hemophilia;

  
  


• 
  

  a stomach ulcer;

  
  


• 
  

  retinitis pigmentosa (an inherited condition of the eye);

  
  


• 
  

  a physical deformity of the penis (such as Peyronie's disease); or

  
  


• 
  

  if you have been told you should not have sexual intercourse for health reasons.

  
  

Sildenafil can decrease blood flow to the optic nerve of the eye, causing sudden vision loss. This has occurred in a small number of people taking sildenafil, most of whom also had heart disease, diabetes, high blood pressure, high cholesterol, or certain pre-existing eye problems, and in those who smoke or are over 50 years old. It is not clear whether sildenafil is the actual cause of vision loss. Stop using sildenafil and get emergency medical help if you have sudden vision loss. FDA pregnancy category B: This medication is not expected to be harmful to an unborn baby. Do not use sildenafil without telling your doctor if you are pregnant or plan to become pregnant during treatment. It is not known if sildenafil 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.

How should I take sildenafil?

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

Revatio is usually taken three times each day, about 4 to 6 hours apart.

Viagra is usually taken only when needed, 30 minutes to 1 hour before sexual activity. You may take it up to 4 hours before sexual activity. Do not take Viagra more than once per day.

Viagra can help you have an erection when sexual stimulation occurs. An erection will not occur just by taking a pill. Follow your doctor's instructions.

During sexual activity, if you become dizzy or nauseated, or have pain, numbness, or tingling in your chest, arms, neck, or jaw, stop and call your doctor right away. You could be having a serious side effect of sildenafil. Store at room temperature away from moisture and heat.

See also: Sildenafil dosage (in more detail)

What happens if I miss a dose?

Viagra is used as needed, so you are not likely to be on a dosing schedule.

If you miss a dose of Revatio, 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 chest pain, nausea, irregular heartbeat, and feeling light-headed or fainting.

What should I avoid while taking sildenafil?

Drinking alcohol can increase certain side effects of sildenafil. Avoid using other medicines to treat impotence, such as alprostadil (Caverject, Muse, Edex) or yohimbine (Yocon, Yodoxin, others), without first talking to your doctor.

Sildenafil side effects

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat. During sexual activity, if you become dizzy or nauseated, or have pain, numbness, or tingling in your chest, arms, neck, or jaw, stop and call your doctor right away. You could be having a serious side effect of sildenafil. Stop using sildenafil and call your doctor at once if you have a serious side effect such as:

• 
  

  sudden vision loss;

  
  


• 
  

  ringing in your ears, or sudden hearing loss;

  
  


• 
  

  chest pain or heavy feeling, pain spreading to the arm or shoulder, nausea, sweating, general ill feeling;

  
  


• 
  

  irregular heartbeat;

  
  


• 
  

  swelling in your hands, ankles, or feet;

  
  


• 
  

  shortness of breath;

  
  


• 
  

  vision changes;

  
  


• 
  

  feeling light-headed, fainting; or

  
  


• penis erection that is painful or lasts 4 hours or longer.

Less serious side effects may include:

• 
  

  warmth or redness in your face, neck, or chest;

  
  


• 
  

  stuffy nose;

  
  


• 
  

  headache;

  
  


• 
  

  memory problems;

  
  


• 
  

  upset stomach; or

  
  


• 
  

  back pain.

  
  

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.

Sildenafil Dosing Information

Usual Adult Dose for Erectile Dysfunction:

Initial (oral): 50 mg orally administered as needed 1 hour prior to anticipated sexual activity. A maximum of one dose per day is recommended.
Maintenance (oral): 25 to 100 mg orally as needed 30 minutes to 4 hours prior to anticipated sexual activity. A maximum of one dose per day is recommended.

Usual Adult Dose for Pulmonary Hypertension:

20 mg orally three times a day taken at least 4 to 6 hours apart
or
10 mg (corresponding to 12.5 mL) administered as an intravenous bolus injection three times a day. A 10 mg dose of the injection is predicted to provide pharmacological effect of sildenafil and its N-desmethyl metabolite equivalent to that of a 20 mg oral dose. The injection is for the continued treatment of patients with pulmonary arterial hypertension (PAH) who are currently prescribed oral sildenafil and who are temporarily unable to take oral medication.

Usual Geriatric Dose for Erectile Dysfunction:

25 mg orally as needed 1 hour prior to anticipated sexual activity.

Usual Pediatric Dose for Pulmonary Hypertension:

Safety and effectiveness of sildenafil in pediatric pulmonary hypertension patients have not been established. Limited pediatric information exists; most pediatric literature consists of case reports or small studies; further studies are needed.

Neonates: Note: A wide range of doses and interpatient variability has been reported; careful dose titration is necessary.

Pulmonary hypertension: Reported range: 0.5 to 3 mg/kg/dose orally every 6 to 12 hours; the largest study was a double-blind, randomized, placebo-controlled trial and used an initial dose of 3 mg/kg/dose every 6 hours in 31 patients; earlier studies used 0.3 to 2 mg/kg/dose every 6-24 hours; duration not established.

Pulmonary hypertension, facilitation of inhaled nitric oxide wean: 0.3 mg/kg/dose orally given once 70 to 90 minutes prior to inhaled nitric oxide discontinuation was used in three patients. Multiple dose therapy in neonates and infants has been reported consisting of 0.22 to 0.47 mg/kg/dose every 6 hours (average duration: 28 days) to facilitate weaning from inhaled nitric oxide in patients who previously failed; duration not established.

Older than 1 yr:
Pulmonary hypertension:
Initial dose: 0.25 to 0.5 mg/kg orally every 4 to 8 hours, increase if needed and if tolerated to 1 mg/kg/dose every 4 to 8 hours; doses as high as 2 mg/kg/dose every 4 hours have been used in several case reports; a wide range of doses has been reported, duration not established. A retrospective trial of 25 patients with chronic lung disease reported treatment duration of 28 to 950 days (median: 241 days).

Pulmonary hypertension, facilitation of inhaled nitric oxide wean (in patients who have not previously failed inhaled nitric oxide wean): Single dose: 0.4 mg/kg/dose (range: 0.3 to 0.5 mg/kg/dose) given once 60 minutes prior to inhaled nitric oxide discontinuation was used in 15 patients (median age: 5.6 months).

What other drugs will affect sildenafil?

Do not take sildenafil with similar medications such as tadalafil (Cialis) or vardenafil (Levitra).

Before taking sildenafil, tell your doctor about all other medications you use for erectile dysfunction, or if you are using any of the following medications:

• 
  

  bosentan (Tracleer);

  
  


• 
  

  cimetidine (Tagamet);

  
  


• 
  

  conivaptan (Vaprisol);

  
  


• 
  

  imatinib (Gleevec);

  
  


• 
  

  isoniazid (for treating tuberculosis);

  
  


• 
  

  rifampin (Rifadin, Rimactane Rifater, Rifamate);

  
  


• 
  

  an antidepressant such as nefazodone;

  
  


• 
  

  an antibiotic such as clarithromycin (Biaxin), dalfopristin/quinupristin (Synercid), erythromycin (E.E.S., EryPed, Ery-Tab, Erythrocin, Pediazole), or telithromycin (Ketek);

  
  


• 
  

  antifungal medication such as itraconazole (Sporanox), ketoconazole (Nizoral), miconazole (Oravig), or voriconazole (Vfend);

  
  


• 
  

  heart or blood pressure medication such as diltiazem (Cardizem, Dilacor, Tiazac), doxazosin (Cardura), nicardipine (Cardene), quinidine (Quin-G), or verapamil (Calan, Covera, Isoptin, Verelan); or

  
  


• 
  

  HIV/AIDS medicine such as atazanavir (Reyataz), delavirdine (Rescriptor), fosamprenavir (Lexiva), indinavir (Crixivan), nelfinavir (Viracept), saquinavir (Invirase), or ritonavir (Norvir, Kaletra).

  
  

This list is not complete and other drugs may interact with sildenafil. 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 sildenafil resources

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

• sildenafil Advanced Consumer (Micromedex) - Includes Dosage Information


• Sildenafil MedFacts Consumer Leaflet (Wolters Kluwer)


• Revatio Prescribing Information (FDA)


• Revatio Consumer Overview


• Sildenafil Citrate Monograph (AHFS DI)


• Viagra Prescribing Information (FDA)


• Viagra MedFacts Consumer Leaflet (Wolters Kluwer)


• Viagra Consumer Overview

Compare sildenafil with other medications

• Erectile Dysfunction
• Pulmonary Arterial Hypertension
• Sexual Dysfunction, SSRI Induced

Where can I get more information?

• Your pharmacist can provide more information about sildenafil.

See also: sildenafil side effects (in more detail)

Tysabri

Pronunciation: NA-ta-LIZ-oo-mab
Generic Name: Natalizumab
Brand Name: Tysabri

Tysabri increases the risk of a certain type of viral brain infection (progressive multifocal leukoencephalopathy [PML]). PML may cause severe disability or death. Your risk of PML may be greater if you currently take or have recently taken other medicines that may weaken your immune system, such as immunosuppressants (eg, 6-mercaptopurine, azathioprine, cyclosporine, methotrexate) or immunomodulators (eg, interferon beta). Your risk of developing PML may also increase with the number of infusions of Tysabri you receive. Tell your doctor at once if you notice any new or worsening symptoms. These may include changes in thinking, eyesight, balance, memory, or strength; clumsiness; confusion; or personality changes.

You can only get Tysabri through a special program called the TOUCH Prescribing Program. Talk with your health care provider if you have questions about this program.

Tysabri is used for:

Treating certain forms of multiple sclerosis (MS) by slowing the worsening of physical disability and reducing the number of symptom flare-ups. It is usually given to patients who cannot use other MS treatments or for whom other MS treatments have not worked well enough. Tysabri is also used to treat moderate to severe Crohn disease in certain patients.

Tysabri is a monoclonal antibody. Exactly how it works is not known. It may block certain inflammatory cells from getting into the brain, which may help slow the progression of MS. Tysabri does not cure MS.

Do NOT use Tysabri if:

• you are allergic to any ingredient in Tysabri


• you have ever had PML


• you have Crohn disease and are also using an immunosuppressant (eg, 6-mercaptopurine, azathioprine, cyclosporine, methotrexate) or a tumor necrosis factor-alpha (TNF-alpha) inhibitor (eg, adalimumab)

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

Before using Tysabri:

Some medical conditions may interact with Tysabri. 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 liver problems, immune system problems, a fever, herpes, shingles, or an infection


• if you have a condition that may weaken your immune system (eg, HIV infection, leukemia, lymphoma) or you have had an organ transplant


• if you are receiving chemotherapy or radiation treatments, or you are taking corticosteroids (eg, prednisone)

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

• Antineoplastics (eg, cisplatin), corticosteroids (eg, prednisone), immunomodulators (eg, interferon beta), immunosuppressants (eg, 6-mercaptopurine, azathioprine, cyclosporine, methotrexate), or TNF-alpha inhibitors (eg, adalimumab) because the risk of developing PML may be increased

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

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

• Tysabri comes with an extra patient information sheet called a Medication Guide. Read it carefully. Read it again each time you get Tysabri refilled.


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


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

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

Important safety information:

• Tysabri may cause dizziness. This effect may be worse if you take it with alcohol or certain medicines. Use Tysabri with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.


• Tysabri is not a cure for MS or Crohn disease. Remain under the care of your doctor.


• Tysabri may lower the ability of your body to fight infection. Avoid contact with people who have colds or infections. Tell your doctor if you notice signs of infection like fever, sore throat, rash, or chills.


• Serious allergic reactions have occurred with the use of Tysabri. If a serious reaction occurs, it is usually within 2 hours after you receive Tysabri. However, a serious reaction may occur at any time. Contact your doctor at once if you develop hives, itching, trouble breathing, chest pain, dizziness, chills, rash, nausea, or flushing.


• Tell your doctor or dentist that you use Tysabri before you receive any medical or dental care, emergency care, or surgery.


• Talk with your doctor before you receive any vaccine.


• Lab tests, including complete blood cell counts, liver function, and magnetic resonance imaging (MRI) scans, may be performed while you use Tysabri. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.


• You will need to see your doctor 3 months and 6 months after your first dose of Tysabri. You will also need to see your doctor at least every 6 months after that. Be sure to keep all doctor and lab appointments.


• Tysabri should be used with extreme caution in CHILDREN younger than 18 years; safety and effectiveness in these children have not been confirmed. Tysabri is not approved for use in children.


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

Possible side effects of Tysabri:

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:

Diarrhea; headache; indigestion; joint pain; mild stomach discomfort; muscle cramps; pain in the arms or legs; tiredness.

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); anxiety; changes in balance, eyesight, memory, strength, or thinking; chest pain or discomfort; clumsiness; confusion; depression; dizziness; fainting; fast heartbeat; feeling cold; fever, chills, cough, or persistent sore throat; flushing; muscle pain; nausea; painful menstrual periods; painful urination or changes in the amount of urine; personality changes; severe or persistent headache or tiredness; severe or persistent stomach or back pain; shortness of breath or wheezing; suicidal thoughts or attempts; swelling of the hands, ankles, or legs; symptoms of liver problems (eg, dark urine; pale stools; right-sided stomach pain; unusual loss of appetite, nausea, vomiting, or weakness; yellowing of the skin or eyes); tremor; vaginal discharge, itching, or odor.

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: Tysabri 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.

Proper storage of Tysabri:

Tysabri is usually handled and stored by a health care provider. Keep Tysabri out of the reach of children and away from pets.

General information:

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


• Tysabri 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 Tysabri. 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 Tysabri resources

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

• Tysabri Prescribing Information (FDA)


• Tysabri Consumer Overview


• Tysabri Monograph (AHFS DI)


• Tysabri Advanced Consumer (Micromedex) - Includes Dosage Information


• Natalizumab Professional Patient Advice (Wolters Kluwer)

Compare Tysabri with other medications

• Crohn's Disease, Maintenance
• Multiple Sclerosis

Saluron

Dosage Form: Tablets

Description

Saluron® (hydroflumethiazide) is a potent oral diuretic-antihypertensive agent of low toxicity. Each tablet contains 50 mg of hydroflumethiazide.

Saluron® is 2H-1,2,4-Benzothiadiazine-7-sulfonamide, 3,4-dihydro-6-(trifluoromethyl)-, 1,1-dioxide. Hydroflumethiazide is very slightly soluble in water, soluble in methanol and freely soluble in acetone. Inactive ingredients: microcrystalline cellulose, lactose, magnesium stearate, colloidal silicon dioxide, and sodium starch glycolate. It has the following structural formula:

Clinical Pharmacology

Hydroflumethiazide is incompletely but fairly rapidly absorbed from the gastrointestinal tract. It appears to have a biphasic biological half-life with an estimated alpha-phase of about 2 hours and an estimated beta-phase of about 17 hours; it has a metabolite with a longer half-life, which is extensively bound to the red blood cells. Hydroflumethiazide is excreted in the urine; its metabolite has also been detected in the urine.

The mechanism of action results in an interference with the renal tubular mechanism of electrolyte reabsorption. At maximal therapeutic dosage, all thiazides are approximately equal in their diuretic potency. The mechanism whereby thiazides function in the control of hypertension is unknown.

Indications and Usage

Saluron® is indicated as adjunctive therapy in edema associated with congestive heart failure, hepatic cirrhosis and corticosteroid and estrogen therapy.

Saluron® has also been found useful in edema due to various forms of renal dysfunction, such as nephrotic syndrome, acute glomerulonephritis, and chronic renal failure.

Saluron® is indicated in the management of hypertension, either as the sole therapeutic agent or to enhance the effectiveness of other antihypertensive drugs in the more severe forms of hypertension.

Usage In Pregnancy

The routine use of diuretics in an otherwise healthy woman is inappropriate and exposes mother and fetus to unnecessary risk. Diuretics do not prevent development of toxemia of pregnancy, and there is no satisfactory evidence that they are useful in the treatment of developed toxemia.

Edema during pregnancy may arise from pathological causes or from the physiologic and mechanical consequences of pregnancy. Thiazides are indicated in pregnancy when edema is due to pathologic causes, just as they are in the absence of pregnancy (however, see Warnings below). Dependent edema in pregnancy, resulting from restriction of venous return by the expanded uterus, is properly treated through elevation of the lower extremities and use of support hose. Use of diuretics to lower intravascular volume in this case is illogical and unnecessary. There is hypervolemia during normal pregnancy which is harmful to neither the fetus nor the mother (in the absence of cardiovascular disease), but which is associated with edema, including generalized edema, in the majority of pregnant women. If this edema produces discomfort, increased recumbency will often provide relief. In rare instances, this edema may cause extreme discomfort which is not relieved by rest. In these cases, a short course of diuretics may provide relief and may be appropriate.

Contraindications

Saluron® is contraindicated in patients with anuria or hypersensitivity to this or other sulfonamide-derived drugs.

Warnings

Saluron® should be used with caution in severe renal disease. In patients with renal disease, thiazide may precipitate azotemia. Cumulative effects of the drug may develop in patients with impaired renal function.

Thiazides should be used with caution in patients with impaired hepatic function or progressive liver disease, since minor alterations of fluid and electrolyte balance may precipitate hepatic coma.

Thiazides may be additive or potentiative of the action of other antihypertensive drugs. Potentiation occurs with ganglionic or peripheral adrenergic blocking drugs.

Sensitivity reactions may occur in patients with a history of allergy or bronchial asthma.

The possibility of exacerbation or activation of systemic lupus erythematosus has been reported.

Precautions

General

All patients receiving thiazide therapy should be observed for clinical signs of fluid or electrolyte imbalance, namely, hyponatremia. hypochloremic alkalosis, and hypokalemia. Serum and urine electrolyte determinations are particularly important when the patient is vomiting excessively or receiving parenteral fluids. Medication such as digitalis may also influence serum electrolytes. Warning signs, irrespective of cause, are: dryness of mouth, thirst, weakness, lethargy, drowsiness, restlessness, muscle pains or cramps, muscular fatigue, hypotension, oliguria, tachycardia, and gastrointestinal disturbances such as nausea and vomiting.

Hypokalemia may develop with thiazides as with any other potent diuretic, especially with brisk diuresis. when severe cirrhosis is present, or during concomitant use of corticosteroids, including ACTH.

Interference with adequate oral electrolyte intake will also contribute to hypokalemia. Digitalis therapy may exaggerate the metabolic effects of hypokalemia, especially with respect to myocardial activity.

Any chloride deficit is generally mild and usually does not require specific treatment, except under extraordinary circumstances (as in liver disease or renal disease). Dilutional hyponatremia may occur in edematous patients in hot weather. Appropriate therapy is water restriction, rather than administration of salt, except in rare instances when the hyponatremia is life-threatening. In actual salt depletion, appropriate replacement is the therapy of choice.

Hyperuricemia may occur or frank gout may be precipitated in certain patients receiving thiazide therapy.

Insulin requirements in diabetic patients may be increased, decreased, or unchanged. Latent diabetes mellitus may become manifested during thiazide administration.

Thiazide drugs may increase the responsiveness to tubocurarine.

The antihypertensive effects of the drug may be enhanced in the postsympathectomy patient.

Thiazides may decrease arterial responsiveness to norepinephrine. This diminution is not sufficient to preclude effectiveness of the pressor agent for therapeutic use.

If progressive renal impairment becomes evident, as indicated by rising nonprotein nitrogen or blood urea nitrogen, a careful reappraisal of therapy is necessary with consideration given to withholding or discontinuing diuretic therapy.

Thiazides may decrease serum PBI levels without signs of thyroid disturbance.

Lithium generally should not be given with diuretics, because they reduce its renal clearance and increase the risk of lithium toxicity. Read circulars for lithium preparations before use of such concomitant therapy with Saluron®.

Information for Patients

This medicine may cause a loss of potassium from your body. To help prevent this, your doctor may want you to:

• take another medicine or


• eat or drink foods having high potassium content (such as orange or other citrus fruit juices), or


• take a potassium supplement

It is very important to follow these directions. Also, it is important not to change your diet on your own. This is more important if you are already on a special diet (as for diabetes), or if you are taking a potassium supplement or a medicine to reduce potassium loss. Extra potassium may not be necessary and, in some cases, could be harmful.

Check with your doctor if you become sick and have severe or continuing vomiting or diarrhea. These problems may cause you to lose additional water and potassium.

Caution: Diabetics-Thiazide diuretics may raise blood sugar levels. While you are using this medicine, be especially careful in testing for sugar in your urine. If you have any questions about this, check with your doctor.

A few people who take this medicine may become more sensitive to sunlight than they are normally. When you begin to take this medicine, avoid too much sun or use of a sunlamp until you see how you react, especially if you tend to burn easily. If you have a severe reaction, check with your doctor.

For patients taking this medicine for high blood pressure:

•Do not take other medicines unless they have been discussed with your doctor. This especially includes over-the-counter (nonprescription) medicines for appetite control, asthma, colds, cough, hay fever, or sinus.

Laboratory Tests

Periodic determination of serum electrolytes to detect possible electrolyte imbalance should be performed at appropriate intervals.

Drug Interactions

Anticoagulants (oral): effects may be decreased when used concurrently with thiazide diuretics; dosage adjustments may be necessary.

Antigout medications: thiazide diuretics may raise the level of blood uric acid; dosage adjustment of antigout medications may be necessary to control hyperuricemia and gout.

Other antihypertensive medications, especially diazoxide; pre-anesthetic and anesthetic agents used in surgery; skeletal muscle relaxants, nondepolarizing, used in surgery: effects may be potentiated when used concurrently with thiazide diuretics; dosage adjustments may be necessary.

Amphotericin B or Corticosteroids, including Corticotropin (ACTH): concurrent use with thiazide diuretics may intensify electrolyte imbalance, particularly hypokalemia.

Cardiac glycosides: concurrent use with thiazide diuretics may enhance the possibility of digitalis toxicity associated with hypokalemia.

Colestipol: may inhibit gastrointestinal absorption of the thiazide diuretics; administration 1 hour before or 4 hours after colestipol is recommended.

Hypoglycemics: thiazide diuretics may raise blood glucose levels. For adult-onset diabetics, dosage adjustment of hypoglycemic medications may be necessary during and after thiazide diuretic therapy; insulin requirements may be increased, decreased, or unchanged.

Lithium salts: concurrent use with thiazide diuretics is not recommended, as they may provoke lithium toxicity because of reduced renal clearance.

Methenamine: effectiveness may be decreased when used concurrently with thiazide diuretics, because of alkalinization of the urine.

Diagnostic Interference

With expected physiologic effects.

Blood and urine glucose levels: usually only in patients with a predisposition to glucose intolerance.

Serum bilirubin levels: displacement from albumin binding.

Serum calcium levels: thiazide diuretics should be discontinued before parathyroid function tests are carried out.

Serum uric acid levels: may be increased.

Serum magnesium, potassium, and sodium levels: may be decreased, serum magnesium levels may increase in uremic patients.

Serum protein-bound iodine (PBI) levels: may be decreased.

Carcinogenesis, Mutagenesis, Impairment of Fertility

No long-term studies in animals have been performed to evaluate carcinogenic or mutagenic potential or impairment of fertility.

Pregnancy

Pregnancy Category D. See "WARNINGS"Section.

Teratogenic Effects

Saluron® can cause fetal harm when administered to a pregnant woman. The hazards include fetal or neonatal jaundice, thrombocytopenia, and possibly other adverse reactions which have occurred in adults. If this drug is used during pregnancy, or if the patient becomes pregnant while taking this drug, the patient should be apprised of the potential hazard to the fetus.

Nonteratogenic Effects

Fetal or neonatal jaundice, thrombocytopenia, and possibly other adverse reactions which have occurred in adults.

Nursing Mothers

Thiazides appear in breast milk. If use of the drug is deemed essential, the patient may consider stopping nursing.

Pediatric Use

Safety and effectiveness in children have not been established.

Adverse Reactions

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

Gastrointestinal system reactions: anorexia, gastric irritation, nausea, vomiting, cramping, diarrhea, constipation, jaundice (intrahepatic cholestatic jaundice), pancreatitis.

Central nervous system reactions: dizziness, vertigo, parathesias, headache, xanthopsia.

Hematologic reactions: leukopenia, agranulocytosis, thrombocytopenia, aplastic anemia.

Dermatologic-Hypersensitivity reactions: purpura, photosensitivity, rash, urticaria, necrotizing angiitis (vasculitis) (cutaneous vasculitis).

Cardiovascular reaction: orthostatic hypotension may occur and may be aggravated by alcohol, barbiturates, or narcotics.

Other: hyperglycemia, glycosuria, hyperuricemia, muscle spasm, weakness, restlessness.

Whenever adverse reactions are moderate or severe, thiazide dosage should be reduced or therapy withdrawn.

Overdosage

Signs and Symptoms

Diuresis, lethargy progressing to coma, with minimal cardiorespiratory depression and with or without significant serum electrolyte changes or dehydration; GI irritation; hypermotility; transient elevation of BUN level.

Treatment

Empty stomach by gastric lavage, taking care to avoid aspiration. Monitor serum electrolyte levels and renal function, and institute supportive measures, as required to maintain hydration, electrolyte balance, respiration, and cardiovascular and renal function. Treat GI effects symptomatically.

Dosage and Administration

In the treatment of edema, the usual initial dose is 50 to 200 mg daily, in 1 or 2 divided doses, reduced to a dose of 25 to 50 mg on alternate days or intermittently. In the treatment of hypertension, the usual dose is 25 to 50 mg daily in 1 or 2 divided doses, either alone, or in conjunction with other antihypertensive agents. A suggested initial dose for children is 1 mg per kg of body weight daily, reduced for maintenance.

Therapy should be individualized according to patient response. This therapy should be titrated to gain maximal therapeutic response, as well as the minimal dose possible to maintain that therapeutic response.

How Supplied

Saluron® Tablets, scored, 50 mg in bottles of 100.

NDC 54092-055-01

Store from 15° to 25°C (59° to 77°F).

Keep this and all medication out of the reach of children.

CAUTION: Federal law prohibits dispensing without prescription.

Saluron  hydroflumenthiazide  tablet

Product Information Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 54092-055 Route of Administration ORAL DEA Schedule

INGREDIENTS Name (Active Moiety) Type Strength hydroflumethiazide (hydroflumethiazide) Active 50 MILLIGRAM  In 1 TABLET microcrystalline cellulose Inactive   lactose Inactive   magnesium stearate Inactive   colloidal silicon dioxide Inactive   sodium starch glycolate Inactive

Product Characteristics Color WHITE Score 2 pieces Shape ROUND Size 8mm Flavor Imprint Code RPC;055 Contains          Coating false Symbol false

Packaging # NDC Package Description Multilevel Packaging 1 54092-055-01 100 TABLET In 1 BOTTLE None

Revised: 07/2006Shire

More Saluron resources

• Saluron Side Effects (in more detail)
• Saluron Dosage
• Saluron Use in Pregnancy & Breastfeeding
• Saluron Drug Interactions
• Saluron Support Group
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