Melokan

Melokan may be available in the countries listed below.

Ingredient matches for Melokan

Meloxicam

Meloxicam is reported as an ingredient of Melokan in the following countries:

• Russian Federation

International Drug Name Search

trimethoprim

Generic Name: trimethoprim (trye METH oh prim)

Brand names: Primsol, Proloprim, Trimpex

What is trimethoprim?

Trimethoprim is an antibiotic that fights bacteria in the body.

Trimethoprim is used to treat bladder infection caused by certain bacteria.

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

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

You should not use this medication if you are allergic to trimethoprim, or if you have any type of anemia (lack of red blood cells).

Before using trimethoprim, tell your doctor if you have kidney disease, liver disease, or a folic acid deficiency.

Take this medication for the full prescribed length of time. Your symptoms may improve before the infection is completely cleared. Trimethoprim will not treat a viral infection such as the common cold or flu. Avoid exposure to sunlight or artificial UV rays (sunlamps or tanning beds). Trimethoprim can make your skin more sensitive to sunlight and sunburn may result. Use a sunscreen (minimum SPF 15) and wear protective clothing if you must be out in the sun.

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

You should not use this medication if you are allergic to trimethoprim, or have certain conditions. Be sure your doctor knows if you have any type of anemia (lack of red blood cells).

Before using trimethoprim, tell your doctor if you are allergic to any drugs, or if you have:

• 
  

  kidney disease;

  
  


• 
  

  liver disease; or

  
  


• 
  

  a folate (folic acid) deficiency.

  
  

If you have any of these conditions, you may need a dose adjustment or special tests to safely use trimethoprim.

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. Trimethoprim can pass into breast milk and may harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby.

How should I take trimethoprim?

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

Take your medicine with a full glass of water.

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

Take this medication for the full prescribed length of time. Your symptoms may improve before the infection is completely cleared. Trimethoprim will not treat a viral infection such as the common cold or flu.

This medication can cause you to have unusual results with certain medical tests. Tell any doctor who treats you that you are using trimethoprim.

Store trimethoprim at room temperature away from moisture and heat.

See also: Trimethoprim dosage (in more detail)

What happens if I miss a dose?

Take the missed dose as soon as you remember. If it is almost time for your next dose, wait until then to take the medicine and skip the missed dose. Do not take extra medicine to make up the missed dose.

What happens if I overdose?

Seek emergency medical attention if you think you have used too much of this medicine.

Overdose symptoms may include nausea, vomiting, dizziness, headache, confusion, weakness, or flu symptoms.

What should I avoid while taking trimethoprim?

Avoid exposure to sunlight or artificial UV rays (sunlamps or tanning beds). Trimethoprim can make your skin more sensitive to sunlight and sunburn may result. Use a sunscreen (minimum SPF 15) and wear protective clothing if you must be out in the sun.

Trimethoprim 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. Call your doctor at once if you have a serious side effect such as:

• 
  

  pale skin, easy bruising or bleeding;

  
  


• 
  

  fever, chills, sore throat, flu symptoms; or

  
  


• 
  

  severe blistering, peeling, and red skin rash.

  
  

Less serious side effects may include:

• 
  

  nausea, vomiting;

  
  


• 
  

  sore or swollen tongue; or

  
  


• 
  

  mild itching or skin rash.

  
  

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.

Trimethoprim Dosing Information

Usual Adult Dose for Cystitis:

100 mg orally every 12 hours or 200 mg orally every 24 hours for 10 days.

Usual Adult Dose for Cystitis Prophylaxis:

100 mg orally at bedtime for 6 weeks to 6 months.

Usual Adult Dose for Pneumocystis Pneumonia:

15 to 20 mg/kg/day in divided doses every 6 hours (in addition to dapsone 100 mg daily). Therapy should be continued for approximately 14 days in non-HIV patients and 21 days in HIV patients.

Trimethoprim has been used with sulfamethoxazole or dapsone for the treatment of Pneumocystis jiroveci (P carinii) pneumonia.

Usual Pediatric Dose for Cystitis:

2 months to 12 years: 2 to 3 mg/kg every 12 hours for 10 days. The efficacy of trimethoprim as a single agent has not been established in children under 12 years.

12 to 18 years: 100 mg orally every 12 hours or 200 mg orally every 24 hours for 10 days.

Usual Pediatric Dose for Otitis Media:

>=6 months: 5 mg/kg every 12 hours for 10 days (investigational).

What other drugs will affect trimethoprim?

Tell your doctor about all other medications you use, especially phenytoin (Dilantin).

This list is not complete and there may be other drugs that can interact with trimethoprim. Tell your doctor about all your prescription and over-the-counter medications, vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start a new medication without telling your doctor.

More trimethoprim resources

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

• trimethoprim Advanced Consumer (Micromedex) - Includes Dosage Information


• Trimethoprim Prescribing Information (FDA)


• Trimethoprim MedFacts Consumer Leaflet (Wolters Kluwer)


• Trimethoprim Monograph (AHFS DI)


• Primsol Solution MedFacts Consumer Leaflet (Wolters Kluwer)


• Proloprim Prescribing Information (FDA)

Compare trimethoprim with other medications

• Bladder Infection
• Otitis Media
• Pneumocystis Pneumonia
• Prevention of Bladder infection

Where can I get more information?

• Your pharmacist can provide more information about trimethoprim.

See also: trimethoprim side effects (in more detail)

Tarceva

Generic Name: erlotinib (Oral route)

er-LOE-ti-nib

Commonly used brand name(s)

In the U.S.

• Tarceva

Available Dosage Forms:

• Tablet

Therapeutic Class: Antineoplastic Agent

Pharmacologic Class: Tyrosine Kinase Inhibitor

Uses For Tarceva

Erlotinib belongs to the group of medicines called antineoplastics. It is used for the treatment and maintenance therapy of advanced or metastatic (cancer that has already spread) non-small cell lung cancer after the failure of other chemotherapy treatment. It is also used together with another medicine called gemcitabine (e.g., Gemzar®) to treat cancer of the pancreas.

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

Before Using Tarceva

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 erlotinib 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 erlotinib 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 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 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.

• Carbamazepine


• Esomeprazole


• Fosphenytoin


• Lansoprazole


• Omeprazole


• Pantoprazole


• Phenobarbital


• Phenytoin


• Rabeprazole


• Rifabutin


• Rifampin


• Rifapentine


• St John's Wort

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.

• Aluminum Carbonate, Basic


• Aluminum Hydroxide


• Aluminum Phosphate


• Calcium Carbonate


• Ciprofloxacin


• Dihydroxyaluminum Aminoacetate


• Dihydroxyaluminum Sodium Carbonate


• Ketoconazole


• Magaldrate


• Magnesium Carbonate


• Magnesium Hydroxide


• Magnesium Oxide


• Magnesium Trisilicate


• Ranitidine


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

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:

• Bleeding problems (e.g., hemolytic anemia, thrombocytopenia) or


• Dehydration or


• Eye or vision problems or


• Heart attack, history of or


• Intestinal or stomach problems (e.g., peptic ulcer), or history of or


• Lung or breathing problems (e.g., interstitial lung disease), history of or


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

• Kidney disease or


• Liver disease—Use with caution. The chance of serious side effects is greatly increased.

Proper Use of Tarceva

Medicines used to treat cancer are very strong and can have many side effects. Before receiving this medicine, make sure you understand all the risks and benefits. It is important for you to work closely with your doctor during your treatment.

It is important that you take erlotinib one hour before or at least two hours after the ingestion of food.

Do not eat grapefruit or drink grapefruit juice while you are using this medicine.

Avoid smoking cigarettes or using other tobacco products while you are using this medicine.

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 form (tablets):
  
  • For lung cancer, non-small cell:
    
    • Adults—150 milligrams (mg) once a day. Your doctor may adjust your dose as needed.
    
    
    • Children—Use and dose must be determined by your doctor.
    
    
  
  
  • For cancer of the pancreas:
    
    • Adults—100 milligrams (mg) once a day. Your doctor may adjust your dose as needed.
    
    
    • 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 Tarceva

It is very important that your doctor check your progress at regular visits to make sure this medicine is working properly. Blood and urine tests may be needed to check for unwanted effects.

Using this medicine while you are pregnant can harm your unborn baby. Use an effective form of birth control to keep from getting pregnant. You should continue to use birth control at least 14 days after you have stopped taking this medicine. However, if you think you have become pregnant while using the medicine, tell your doctor right away.

It is important that you talk to your doctor right away if you have severe or continuing diarrhea, nausea, loss of appetite, or vomiting.

Call your doctor right away if you have unexplained shortness of breath, cough, and fever that comes on suddenly.

Check with your doctor right away if you have bloody or black, tarry stools; severe stomach pain; or vomiting of blood or material that looks like coffee grounds. These could be symptoms of a serious stomach or bowel problem.

Liver problems may occur while you are using this medicine. Stop using this medicine and check with your doctor right away if you are having more than one of these symptoms: abdominal pain or tenderness; clay-colored stools; dark urine; decreased appetite; fever; headache; itching; loss of appetite; skin rash; swelling of the feet or lower legs; unusual tiredness or weakness; or yellow eyes or skin.

Serious skin reactions can occur with this medicine. Check with your doctor right away if you have blistering, peeling, or loosening of the skin; red skin lesions; severe acne or skin rash; sores or ulcers on the skin; or fever or chills while you are using this medicine.

You may use alcohol-free emollient creams, sunscreen, or sun blocking lotions to prevent dry skin and other serious skin reactions.

Check with your doctor immediately if blurred vision, difficulty in reading, any other change in vision, or eye pain or irritation occurs during or after treatment. Your doctor may want you to have your eyes checked by an ophthalmologist (eye doctor).

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 (St. John's wort) or vitamin supplements.

Tarceva 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

• Burning, tingling, numbness or pain in the hands, arms, feet, or legs


• cough or hoarseness


• diarrhea, severe


• difficult or labored breathing


• fever or chills


• lower back or side pain


• painful or difficult urination


• rash, severe


• sensation of pins and needles


• shortness of breath


• stabbing chest pain


• tightness in the chest


• wheezing

Rare

• Bloody or black, tarry stool


• blurred vision


• chest pain or discomfort


• constipation


• convulsions (seizures)


• eye irritation or redness


• inability to speak


• pain or discomfort in the arms, jaw, back, or neck


• severe stomach pain


• slurred speech


• sudden, severe chest pain


• sudden, severe headache


• sudden, severe weakness in the arm or leg on one side of the body


• sweating


• vision changes


• vomiting of blood or material that looks like coffee grounds

Incidence not known

• Agitation


• blistering, peeling, or loosening of the skin


• bloody nose


• burning feeling in the chest or stomach


• burning upper abdominal or stomach pain


• coma


• confusion


• dark-colored urine


• darkening of the skin


• decreased urine output


• general feeling of tiredness or weakness


• headache


• increased thirst


• irregular heartbeat


• lethargy


• light-colored stools


• loss of appetite


• mood changes


• muscle twitching


• nausea or vomiting


• rapid weight gain


• red skin lesions, often with a purple center


• sore throat


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


• stomach pain, continuing


• stupor


• swelling of the face, ankles, or hands


• tenderness in the stomach area


• trouble breathing


• unusual tiredness or weakness


• yellow eyes or 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

• Acid or sour stomach


• belching


• blemishes on the skin


• bloated, full feeling


• bone pain


• burning, dry, or itching eyes


• diarrhea, mild


• difficulty with moving


• dizziness


• dry eyes


• dry skin


• excess air or gas in the stomach or intestines


• excessive tearing


• fear


• feeling sad or empty


• feeling unusually cold


• hair loss


• headache


• heartburn


• indigestion


• irritability


• itching skin


• joint pain


• loss of interest or pleasure


• muscle aching or cramping


• muscle pains or stiffness


• nervousness


• passing gas


• pimples


• rash, mild


• redness, pain, or swelling of the eye, eyelid, or inner lining of the eyelid


• shivering


• sleeplessness


• stomach discomfort, upset, or pain


• swelling


• swelling or inflammation of the mouth


• swollen joints


• thinning of the hair


• tiredness


• trouble with concentrating


• trouble or inability to sleep


• weight loss

Less common

• Loosening of the fingernails


• redness or soreness around the fingernails

Incidence not known

• Brittle and loose nails


• discharge, excessive tearing


• increased hair growth, especially on the face

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: Tarceva 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 Tarceva resources

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

• Tarceva Prescribing Information (FDA)


• Tarceva Consumer Overview


• Tarceva Monograph (AHFS DI)


• Tarceva MedFacts Consumer Leaflet (Wolters Kluwer)


• Erlotinib Professional Patient Advice (Wolters Kluwer)

Compare Tarceva with other medications

• Non-Small Cell Lung Cancer
• Pancreatic Cancer
• Renal Cell Carcinoma

Tarocort

Generic Name: hydrocortisone valerate (Topical application route)

hye-droe-KOR-ti-sone VAL-er-ate

Commonly used brand name(s)

In the U.S.

• Westcort

In Canada

• Hydroval


• Tarocort

Available Dosage Forms:

• Ointment


• Cream

Therapeutic Class: Corticosteroid, Intermediate

Pharmacologic Class: Hydrocortisone

Uses For Tarocort

Hydrocortisone valerate topical is used to help relieve redness, itching, swelling, or other discomfort caused by skin conditions. This medicine is a corticosteroid (cortisone-like medicine or steroid).

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

Before Using Tarocort

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 hydrocortisone valerate topical in the pediatric population. However, because of this medicine's toxicity, it should be used with caution. Children and teenagers who must use this medicine should be checked often by their doctor since hydrocortisone valerate topical may be absorbed through the skin and can affect growth or cause other unwanted effects. Safety and effectiveness have not been established.

Geriatric

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

Interactions with Medicines

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. Tell your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.

Interactions with Food/Tobacco/Alcohol

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

Other Medical Problems

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

• Cushing's syndrome (adrenal gland disorder) or


• Diabetes or


• Hyperglycemia (high blood sugar) or


• Intracranial hypertension (increased pressure in the head)—Use with caution. May make these conditions worse.

• Infection at or near the place of application or


• Large sores, broken skin, or severe injury at the area of application—The chance of side effects may be increased.

Proper Use of hydrocortisone valerate

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

Use this medicine exactly as directed by your doctor. Do not use it for any other condition without first checking with your doctor. This medicine may cause unwanted effects if it is used too much, because more of it is absorbed into the body through the skin.

Wash your hands with soap and water before and after using this medicine.

Be very careful not to get this medicine in your eyes. Wash your hands after using your finger to apply the medicine. If you accidentally get this medicine in your eyes, flush them with water.

Apply a thin layer of this medicine to the affected area of the skin. Rub it in gently.

Unless otherwise directed by your doctor, do not apply this medicine to open wounds, burns, or broken or inflamed skin.

This medicine should only be used for problems being treated by your doctor. Check with your doctor before using it for other problems, especially if you think that an infection may be present. This medicine should not be used to treat certain kinds of skin infections or serious problems, such as severe burns.

Do not bandage or otherwise wrap the skin being treated unless directed to do so by your doctor.

If your doctor has ordered an occlusive dressing (airtight covering, such as kitchen plastic wrap or a special patch) to be applied over this medicine, make sure you know how to apply it. Since occlusive dressings increase the amount of medicine absorbed through your skin and the possibility of side effects, use them only as directed. If you have any questions about this, check with your doctor.

Do not use this medicine on the face, groin, or underarms unless directed to do so by your doctor.

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 topical dosage forms (cream and ointment):
  
  • For redness, itching, and swelling of the skin:
    
    • Adults—Apply to the affected area of the skin two or three times a day.
    
    
    • Children—Use and dose must be determined by your doctor.
    
    
  
  

Missed Dose

If you miss a dose of this medicine, apply 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.

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 Tarocort

It is very important that your doctor check your or your child's progress at regular visits for any problems or unwanted effects that may be caused by this medicine.

If your symptoms do not improve within 2 weeks, or if it become worse, check with your doctor.

After applying this medicine to the skin of your child, watch the child carefully to make sure that he or she does not get any of the medicine in the eyes or mouth. This medicine can cause serious side effects, especially in children, if it gets into the mouth and is swallowed.

Using too much of this medicine or using it for a long time may increase your risk of having adrenal gland problems. The risk is greater for children and for patients who use large amounts for a long time. Talk to your doctor if you or your child have more than one of these symptoms while you are using this medicine: blurred vision; dizziness or fainting; fast, irregular, or pounding heartbeat; increased thirst or urination; irritability; or unusual tiredness or weakness.

Stop using this medicine and check with your doctor right away if you or your child have a skin rash, burning, stinging, swelling, or irritation on the skin.

Avoid using tight-fitting diapers or plastic pants on a child if this medicine is being used on the child's diaper area. Plastic pants and tight-fitting diapers may increase the chance of absorption of the medicine through the skin and the chance of side effects.

Do not use cosmetics or other skin care products on the treated skin areas.

Tarocort 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

• Skin rash, encrusted, scaly, and oozing


• stinging

Less common

• Burning, itching, redness, skin rash, swelling, or soreness at the application site


• cough or hoarseness


• dry skin


• fever or chills


• itching in the genital or other skin areas


• lower back or side pain


• painful or difficult urination


• rash


• rash with flat lesions or small raised lesions on the skin


• skin irritation

Incidence not known

• Blistering, burning, crusting, dryness, or flaking of the skin


• itching, scaling, severe redness, soreness, or swelling of the skin


• redness and scaling around the mouth


• thinning of the skin with easy bruising, especially when used on facial or intertriginous areas

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:

Less common

• Diarrhea


• indigestion


• loss of appetite


• nausea or vomiting


• passing of gas


• stomach pain, fullness, or discomfort

Incidence not known

• Acne or pimples


• burning and itching of the skin with pinhead-sized red blisters


• burning, itching, and pain in hairy areas, or pus at the root of the hair


• increased hair growth on the forehead, back, arms, and legs


• lightening of normal skin color


• lightening of treated areas of dark skin


• reddish purple lines on the arms, face, legs, trunk, or groin


• softening of the skin

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.

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More Tarocort resources

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

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• Anal Itching
• Aphthous Stomatitis, Recurrent
• Atopic Dermatitis
• Dermatitis
• Eczema
• Gingivitis
• Hemorrhoids
• Proctitis
• Pruritus
• Psoriasis
• Seborrheic Dermatitis
• Skin Rash
• Ulcerative Colitis, Active

Haemophilus B Conjugate/Hepatitis B Vaccine

Pronunciation: hem-OFF-fill-us B KON-ju-get/hep-a-TYE-tiss
Generic Name: Haemophilus B Conjugate/Hepatitis B
Brand Name: Comvax

Haemophilus B Conjugate/Hepatitis B Vaccine is used for:

Preventing infection caused by Haemophilus influenzae type B bacteria and hepatitis B virus.

Haemophilus B Conjugate/Hepatitis B Vaccine is a vaccine. It works by stimulating the body to produce antibodies against Haemophilus influenzae type B bacteria and hepatitis B virus.

Do NOT use Haemophilus B Conjugate/Hepatitis B Vaccine if:

• you are allergic to any ingredient in Haemophilus B Conjugate/Hepatitis B Vaccine


• you have a fever

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

Before using Haemophilus B Conjugate/Hepatitis B Vaccine:

Some medical conditions may interact with Haemophilus B Conjugate/Hepatitis B Vaccine. 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 an infection, heart or lung problems, multiple sclerosis, a bleeding disorder (eg, hemophilia), low platelet counts, or cancer


• if you have a weakened immune system or are taking an immunosuppressive medicine (eg, cyclosporine)

Some MEDICINES MAY INTERACT with Haemophilus B Conjugate/Hepatitis B Vaccine. Tell your health care provider if you are taking any other medicines, especially any of the following:

• Immunosuppressive medicines (eg, cyclosporine) because they may decrease Haemophilus B Conjugate/Hepatitis B Vaccine's effectiveness

This may not be a complete list of all interactions that may occur. Ask your health care provider if Haemophilus B Conjugate/Hepatitis B Vaccine 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 Haemophilus B Conjugate/Hepatitis B Vaccine:

Use Haemophilus B Conjugate/Hepatitis B Vaccine as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• Haemophilus B Conjugate/Hepatitis B Vaccine is usually administered as an injection at your doctor's office, hospital, or clinic.


• If Haemophilus B Conjugate/Hepatitis B Vaccine contains particles or is discolored, or if the vial is cracked or damaged in any way, do not use it.


• If you miss a dose of Haemophilus B Conjugate/Hepatitis B Vaccine, contact your doctor immediately.

Ask your health care provider any questions you may have about how to use Haemophilus B Conjugate/Hepatitis B Vaccine.

Important safety information:

• Haemophilus B Conjugate/Hepatitis B Vaccine may cause fever, irritability, and redness, tenderness, or a lump at the injection site. These symptoms should go away within 1 to 2 days.


• Haemophilus B Conjugate/Hepatitis B Vaccine is not recommended for use in CHILDREN younger than 6 weeks of age or older than 15 years of age. Safety and effectiveness in these age groups have not been confirmed.


• PREGNANCY and BREAST-FEEDING: Do not use Haemophilus B Conjugate/Hepatitis B Vaccine if you are pregnant. If you suspect that you could be pregnant, contact your doctor immediately. It is unknown if Haemophilus B Conjugate/Hepatitis B Vaccine is excreted in breast milk. If you are or will be breast-feeding while you are using Haemophilus B Conjugate/Hepatitis B Vaccine, check with your doctor or pharmacist to discuss the risks to your baby.

Possible side effects of Haemophilus B Conjugate/Hepatitis B Vaccine:

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:

Crying; irritability; loss of appetite; low-grade fever; redness, tenderness, or a lump at the injection site; sleepiness; vomiting.

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); high fever (above 103 degrees F).

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 Haemophilus B Conjugate/Hepatitis B Vaccine:

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

General information:

• If you have any questions about Haemophilus B Conjugate/Hepatitis B Vaccine, please talk with your doctor, pharmacist, or other health care provider.


• Haemophilus B Conjugate/Hepatitis B Vaccine 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 Haemophilus B Conjugate/Hepatitis B Vaccine. 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 Haemophilus B Conjugate/Hepatitis B resources

• Haemophilus B Conjugate/Hepatitis B Use in Pregnancy & Breastfeeding
• Haemophilus B Conjugate/Hepatitis B Drug Interactions
• Haemophilus B Conjugate/Hepatitis B Support Group
• 0 Reviews for Haemophilus B Conjugate/Hepatitis B - Add your own review/rating

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• Haemophilus influenzae Prophylaxis
• Hepatitis B Prevention

Habitek

Habitek may be available in the countries listed below.

Ingredient matches for Habitek

Cetirizine

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

• Greece

International Drug Name Search

Telavancin Hydrochloride

Class: Glycopeptides
ATC Class: J01XA03
VA Class: AM900
Chemical Name: Vancomycin, N3″-[2-(decylamino)ethyl}-29-{[(phosphono-methyl)-amino]-methyl}-hydrochloride
Molecular Formula: C₈₀H₁₀₆C₁₂N₁₁O₂₇P • xHCl (where x=1 to 3)
CAS Number: 380636-75-9
Brands: Vibativ

• Fetal Risk


• 
  

  Women of childbearing potential should have a serum pregnancy test to exclude pregnancy prior to administration of telavancin.¹

  
  


• 
  

  Avoid use of telavancin during pregnancy unless potential benefits to the woman outweigh potential risks to the fetus.¹

  
  


• 
  

  Concerns about potential adverse developmental outcomes in humans based on adverse developmental outcomes observed in 3 animal species given telavancin at clinically relevant doses during the period of organogenesis.¹ (See Pregnancy under Cautions.)

  
  

REMS:

FDA approved a REMS for telavancin to ensure that the benefits of a drug outweigh the risks. The REMS may apply to one or more preparations of telavancin and consists of the following: medication guide and communication plan. See the FDA REMS page () or the ASHP REMS Resource Center ().

Introduction

Antibacterial; lipoglycopeptide; synthetic derivative of vancomycin.^{1 2 3 4 5}

Uses for Telavancin Hydrochloride

Skin and Skin Structure Infections

Treatment of complicated skin and skin structure infections caused by susceptible Staphylococcus aureus (including methicillin-resistant S. aureus [MRSA; also known as oxacillin-resistant S. aureus or ORSA]), Streptococcus pyogenes (group A β-hemolytic streptococci), S. agalactiae (group B streptococci), S. anginosus group (includes S. anginosus, S. intermedius, S. constellatus), or Enterococcus faecalis (vancomycin-susceptible strains only).¹

Indicated only for treatment of certain infections caused by certain gram-positive bacteria; if documented or presumed pathogens include gram-negative or anaerobic bacteria, concomitant use of another anti-infective may be clinically indicated.¹

Telavancin Hydrochloride Dosage and Administration

Administration

Administer by IV infusion.¹

IV Infusion

Must be reconstituted and then further diluted prior to administration.¹

Should not be admixed or added to solutions containing other drugs.¹

If the same IV line is used for sequential infusion of other drugs, flush the IV line with 0.9% sodium chloride injection, 5% dextrose injection, or lactated Ringer's injection before and after the telavancin infusion.¹

Reconstitution

Reconstitute vials containing 250 or 750 mg of telavancin with 15 or 45 mL, respectively, of 5% dextrose injection, sterile water for injection, or 0.9% sodium chloride injection to provide a solution containing 15 mg/mL.¹

Discard vial if the vacuum is insufficient to pull diluent into vial.¹

Mix thoroughly and ensure that drug has dissolved completely.¹ Usually reconstitutes in <2 minutes, but reconstitution may take up to 20 minutes.¹

Dilution

For doses of 150–800 mg, withdraw correct dose from the reconstituted vial and add to 100–250 mL of appropriate IV infusion fluid (i.e., 0.9% sodium chloride injection, 5% dextrose injection, lactated Ringer's injection).¹

For doses <150 mg or >800 mg, withdraw correct dose from the reconstituted vial and add to a volume of appropriate IV infusion fluid (i.e., 0.9% sodium chloride injection, 5% dextrose injection, lactated Ringer's injection) that results in a final concentration of 0.6–8 mg/mL.¹

Rate of Administration

Administer by IV infusion over 1 hour.¹ Avoid rapid IV infusion.¹ (See Infusion Reactions under Cautions.)

Dosage

Available as telavancin hydrochloride; dosage is expressed in terms of telavancin.¹

Adults

Skin and Skin Structure Infections

IV

10 mg/kg once every 24 hours for 7–14 days.¹

Duration of therapy based on severity and location of infection and patient's clinical and bacteriologic response.¹

Special Populations

Hepatic Impairment

Dosage adjustment not needed in adults with mild to moderate hepatic impairment.^{1 8}

Renal Impairment

Reduce dosage in adults with Cl_cr 10–50 mL/minute.¹ Data insufficient to make dosage recommendations for adults with end-stage renal disease (Cl_cr <10 mL/minute), including those undergoing hemodialysis.¹

Table 1. Telavancin Dosage for Adults with Renal Impairment1

Clcr Calculated Using Cockcroft-Gault Formula (mL/minute)	Telavancin Dosage
>50	10 mg/kg once every 24 hours
30–50	7.5 mg/kg once every 24 hours
10 to <30	10 mg/kg once every 48 hours

Geriatric Patients

Select dosage with caution because of age-related decreases in renal function.¹ (See Geriatric Use under Cautions.)

Cautions for Telavancin Hydrochloride

Contraindications

• 
  

  Manufacturer states none known.¹

  
  

Warnings/Precautions

Warnings

Fetal/Neonatal Morbidity

Adverse developmental outcomes reported in 3 animal species given telavancin at clinically relevant doses during the period of organogenesis.¹

Exclude pregnancy (negative serum pregnancy test) prior to initiation of telavancin in females of childbearing potential (i.e., those who have not had complete absence of menses for ≥24 months, medically confirmed menopause or primary ovarian failure, hysterectomy, bilateral oophorectomy, or tubal ligation).¹

Use effective contraception to prevent pregnancy during treatment.¹

Avoid use of telavancin during pregnancy unless potential benefits to the woman outweigh potential risks to the fetus.¹ (See Pregnancy under Cautions.)

FDA required and approved a Risk Evaluation and Mitigation Strategy (REMS) for telavancin;¹⁷ goal of the telavancin REMS is to avoid unintended telavancin exposure in pregnant women by educating health-care providers and patients about potential risk of fetal developmental toxicity and recommended measures to exclude and prevent pregnancy.¹⁷ The REMS requires that a telavancin medication guide be provided to patient each time the drug is dispensed and outlines a communication plan requiring initial and periodic communications from manufacturer to certain targeted groups of prescribers and pharmacists.¹⁷

Nephrotoxicity

Renal impairment reported in patients receiving telavancin.¹ In patients with normal baseline S_cr concentrations, increased S_cr (1.5 times baseline) reported more frequently in telavancin-treated patients than in vancomycin-treated patients.¹

Adverse renal effects more likely in patients with conditions known to increase the risk of renal impairment (e.g., preexisting renal disease, diabetes mellitus, CHF, hypertension) and in those receiving concomitant therapy with an agent that affects renal function (e.g., NSAIAs, certain diuretics, ACE inhibitors).¹

Monitor renal function (i.e., S_cr, Cl_cr).¹ Perform renal function tests prior to initiation of telavancin, every 48–72 hours during therapy (more frequently if indicated), and at end of therapy.¹

If renal function decreases, weigh benefits of continuing telavancin versus discontinuing the drug and initiating an alternative anti-infective.¹

Infusion Reactions

Rapid IV administration of glycopeptide anti-infectives (including telavancin) can result in a reaction referred to as the “red-man syndrome.”¹ Flushing of the upper body, urticaria, pruritus, or rash may occur.¹

To reduce risk of infusion-related reactions, give IV infusion over 1 hour.¹ If an infusion reaction occurs, the reaction may cease if the infusion is discontinued or slowed.¹

Superinfection/Clostridium difficile-associated Diarrhea and Colitis (CDAD)

Possible emergence and overgrowth of nonsusceptible organisms, including fungi.¹ Monitor carefully; institute appropriate therapy if superinfection occurs.¹

Treatment with anti-infectives alters normal colon flora and may permit overgrowth of Clostridium difficile.^{1 12 13 14 15 16} C. difficile-associated diarrhea and colitis (CDAD; also known as antibiotic-associated diarrhea and colitis or pseudomembranous colitis) has been reported with nearly all anti-infectives and may range in severity from mild diarrhea to fatal colitis.¹ Hypertoxin-producing strains of C. difficile are associated with increased morbidity and mortality since they may be refractory to anti-infectives and colectomy may be required.¹

Consider CDAD if diarrhea develops during or after therapy and manage accordingly.^{1 12 13 14 15 16} Obtain a careful medical history since CDAD may occur as late as ≥2 months after anti-infective therapy is discontinued.¹

If CDAD is suspected or confirmed, anti-infectives not directed against C. difficile may need to be discontinued.¹ Manage moderate to severe cases with fluid, electrolyte, and protein supplementation, anti-infective therapy active against C. difficile (e.g., oral metronidazole or vancomycin), and surgical evaluation when clinically indicated.^{1 12 13 14 15 16}

Selection and Use of Anti-infectives

To reduce development of drug-resistant bacteria and maintain effectiveness of telavancin and other antibacterials, use only for treatment of infections proven or strongly suspected to be caused by susceptible bacteria.¹

When selecting or modifying anti-infective therapy, use results of culture and in vitro susceptibility testing.¹ In the absence of such data, consider local epidemiology and susceptibility patterns when selecting anti-infectives for empiric therapy.¹

If documented or presumed pathogens include gram-negative or anaerobic bacteria, concomitant use of an anti-infective active against such bacteria may be clinically indicated.¹ (See Uses.)

Cardiovascular Effects

Prolongation of the QT_c interval reported.¹ Caution advised if used with drugs known to prolong QT interval.¹

Avoid use in individuals with congenital long QT syndrome, known prolongation of the QT_c interval, uncompensated heart failure, or severe left ventricular hypertrophy; such individuals not included in telavancin clinical trials.¹

Hematologic Effects

Does not interfere with coagulation and has no effect on platelet aggregation.¹ Increased risk of bleeding not observed in clinical trials.¹ Evidence of hypercoagulability not observed; healthy adults receiving telavancin have normal levels of D-dimer and fibrin degradation products.¹

Interferes with certain tests used to monitor coagulation (i.e., PT, INR, aPTT, activated clotting time, tests based on factor Xa).¹ (See Specific Drugs and Laboratory Tests under Interactions.)

Specific Populations

Pregnancy

Category C.¹ Pregnancy registry at 888-658-4228.¹

In reproduction studies in rats, rabbits, and minipigs, there was evidence that telavancin has the potential to cause limb and skeletal malformations and reduced fetal weight.¹

Has not been evaluated in pregnant women, but animal data raise concerns about potential adverse developmental outcomes in humans.¹ Avoid use during pregnancy unless potential benefits to the patient outweigh potential risks to the fetus.¹ (See Fetal/Neonatal Morbidity under Cautions.)

Lactation

Not known whether telavancin is distributed into milk in humans.¹ Use with caution.¹

Pediatric Use

Safety and efficacy not established in children or adolescents <18 years of age.¹

Geriatric Use

In clinical studies evaluating telavancin for treatment of complicated skin and skin structure infections, the drug appeared to be less effective in adults ≥65 years of age relative to adults <65 years of age.¹

No overall differences in frequency of treatment-emergent adverse events compared with younger adults; however, incidence of adverse events indicating renal impairment was higher in geriatric adults than in younger adults.¹

Substantially eliminated by kidneys; select dosage with caution since geriatric patients are more likely to have decreased renal function.¹

Hepatic Impairment

Pharmacokinetics not altered in adults with moderate hepatic impairment (Child-Pugh class B);^{1 8} pharmacokinetics not evaluated in those with severe hepatic impairment (Child-Pugh class C).¹ Dosage adjustment not needed in adults with mild to moderate hepatic impairment.^{1 8}

Renal Impairment

In clinical studies evaluating telavancin for treatment of complicated skin and skin structure infections, the drug appeared to be less effective in adults with Cl_cr ≤50 mL/minute relative to those with Cl_cr >50 mL/minute.¹ Consider possible reduced effectiveness when selecting an anti-infective for adults with baseline moderate or severe renal impairment (Cl_cr ≤50 mL/minute).¹

Risk of adverse renal effects may be greater in patients with preexisting renal impairment or risk factors for renal dysfunction.¹ (See Nephrotoxicity under Cautions.)

Reduce dosage in adults with Cl_cr 10–50 mL/minute.¹ (See Renal Impairment under Dosage and Administration.)

Hydroxypropyl-β-cyclodextrin (an inactive ingredient in the formulation) may accumulate in individuals with renal impairment.¹ If renal toxicity is suspected, consider an alternative anti-infective.¹

Common Adverse Effects

GI effects (taste disturbance,^{1 2 3} nausea,^{1 2 3} vomiting,^{1 2 3} constipation² ), headache,^{2 3} insomnia,^{2 3} foamy urine.^{1 2}

Interactions for Telavancin Hydrochloride

Drugs Affecting or Metabolized by Hepatic Microsomal Enzymes

Inhibits CYP 3A4/5.¹

Specific Drugs and Laboratory Tests

Drug or Test	Interaction	Comments
Aminoglycosides (amikacin, gentamicin)	Gentamicin: In vitro evidence of synergistic antibacterial effects against MRSA6 Amikacin or gentamicin: No in vitro evidence of antagonistic antibacterial effects against telavancin-susceptible staphylococci, streptococci, or enterococci1
Aztreonam	No effect on pharmacokinetics of either drug1 9 No in vitro evidence of antagonistic antibacterial effects against telavancin-susceptible staphylococci, streptococci, or enterococci1	Dosage adjustments not needed1
Carbapenems (imipenem, meropenem)	Meropenem: In vitro evidence of synergistic antibacterial effects against MRSA6 Imipenem or meropenem: No in vitro evidence of antagonistic antibacterial effects against telavancin-susceptible staphylococci, streptococci, or enterococci1
Cephalosporins	Cefepime or ceftriaxone: In vitro evidence of synergistic antibacterial effects against MRSA6 Cefepime or ceftriaxone: No in vitro evidence of antagonistic antibacterial effects against telavancin-susceptible staphylococci, streptococci, or enterococci1
Co-trimoxazole	No in vitro evidence of antagonistic antibacterial effects against telavancin-susceptible staphylococci, streptococci, or enterococci1
Fluoroquinolones	Ciprofloxacin: In vitro evidence of synergistic antibacterial effects against MRSA6 Ciprofloxacin: No in vitro evidence of antagonistic antibacterial effects against telavancin-susceptible staphylococci, streptococci, or enterococci1
Midazolam	No effect on pharmacokinetics of either drug1 7
Penicillins	Piperacillin and tazobactam: No effect on pharmacokinetics of either drug1 9 Oxacillin or piperacillin and tazobactam: No in vitro evidence of antagonistic antibacterial effects against telavancin-susceptible staphylococci, streptococci, or enterococci1	Piperacillin and tazobactam: Dosage adjustments not needed1
Rifampin	In vitro evidence of synergistic antibacterial effects against MRSA6 No in vitro evidence of antagonistic antibacterial effects against telavancin-susceptible staphylococci, streptococci, or enterococci1
Tests, coagulation	Telavancin interferes with PT, INR, aPTT, activated clotting time, and tests based on factor Xa if blood samples are drawn 0–18 hours after a dose of the anti-infective1 Does not affect thrombin time, whole blood (Lee-White) clotting time, ex vivo platelet aggregation, chromogenic factor Xa assay, functional (chromogenic) factor X assay, bleeding time, or tests for D-dimer or fibrin degradation products1	Draw blood samples for PT, INR, aPTT, activated clotting time, and tests based on factor Xa just before a telavancin dose1
Tests, urine protein	Telavancin interferes with urine qualitative dipstick protein assays and quantitative dye methods used to measure urine protein (e.g., pyrogallol red-molybdate);1 does not affect microalbumin assays1	Use microalbumin assays to monitor urinary protein excretion in patients receiving telavancin1

Telavancin Hydrochloride Pharmacokinetics

Absorption

Plasma Concentrations

In healthy young adults, pharmacokinetics are linear following single IV doses of 5–12.5 mg/kg or multiple IV doses of 7.5–15 mg/kg given once daily for up to 7 days.¹

Steady-state concentrations achieved by day 3 of once-daily dosage.¹

Special Populations

AUC increased in patients with renal impairment.¹

Distribution

Extent

Concentration in skin blister fluid is 40% of plasma concentrations after administration of 7.5 mg/kg once daily for 3 days.¹

Not known whether telavancin is distributed into milk in humans.¹

Plasma Protein Binding

90%, primarily albumin.¹ Protein binding not affected by renal or hepatic impairment.¹

Elimination

Metabolism

Metabolic pathway not elucidated to date.¹ Three hydroxylated metabolites identified; the major metabolite is THRX-651540.¹

Not metabolized by CYP isoenzymes 1A2, 2C9, 2C19, 2D6, 3A4, 3A5, or 4A11.¹

Elimination Route

Approximately 76% of a dose recovered in urine; <1% of dose recovered in feces.¹

In adults with end-stage renal disease, approximately 5.9% of a dose is removed by 4 hours of hemodialysis.¹ In vitro date indicate telavancin may be removed by continuous venovenous hemofiltration (CVVH).¹

Half-life

Approximately 8 hours in adults.¹

Special Populations

Pharmacokinetics not altered in geriatric individuals based solely on age.¹

Pharmacokinetics altered by decreased renal function.¹

No clinically important change in pharmacokinetics in adults with moderate hepatic impairment (Child-Pugh class B).^{1 8} Not evaluated in adults with severe hepatic impairment (Child-Pugh class C).¹

Stability

Storage

Parenteral

Powder for Injection

2–8°C; may be exposed to temperatures up to 25°C.¹ Avoid excessive heat.¹

Following reconstitution and further dilution, administer within 4 hours when stored at room temperature or within 72 hours when stored at 2–8°C.¹

Actions

• 
  

  Lipoglycopeptide antibacterial.^{1 2 3 4 5} Synthetic derivative of vancomycin.^{1 2 3 4 5}

  
  


• 
  

  Usually bactericidal in action.¹ Inhibits bacterial cell wall synthesis by inhibiting peptidoglycan synthesis and blocking the transglycosylation step.^{1 4} Binds to the bacterial membrane and disrupts membrane barrier function.^{1 4}

  
  


• 
  

  Active against some gram-positive bacteria, including Staphylococcus aureus (including methicillin-resistant S. aureus [MRSA; also known as oxacillin-resistant S. aureus or ORSA]),^{1 2 3 5 11} Streptococcus pyogenes (group A β-hemolytic streptococci),¹ S. agalactiae (group B streptococci),¹ S. anginosus group (includes S. anginosus, S. intermedius, S. constellatus),¹ and Enterococcus faecalis (vancomycin-susceptible strains only).^{1 5}

  
  


• 
  

  Some vancomycin-resistant enterococci have reduced susceptibility to telavancin.^{1 5} Cross-resistance between telavancin and other anti-infectives not reported to date.¹

  
  

Advice to Patients

• 
  

  Telavancin medication guide must be provided to patient each time the drug is dispensed;¹⁷ importance of patient reading the medication guide prior to initiating telavancin therapy and each time the prescription is refilled.¹

  
  


• 
  

  Advise patients that antibacterials (including telavancin) should only be used to treat bacterial infections and not used to treat viral infections (e.g., the common cold).¹

  
  


• 
  

  Importance of completing full course of therapy, even if feeling better after a few days.¹

  
  


• 
  

  Advise patients that skipping doses or not completing the full course of therapy may decrease effectiveness and increase the likelihood that bacteria will develop resistance and will not be treatable with telavancin or other antibacterials in the future.¹

  
  


• 
  

  Advise patients that diarrhea is a common problem caused by anti-infectives and usually ends when the drug is discontinued.¹ Importance of contacting a clinician if watery and bloody stools (with or without stomach cramps and fever) occur during or as late as 2 months or longer after the last dose.¹

  
  


• 
  

  Advise patients about the common adverse effects reported with telavancin (e.g., taste disturbance, nausea, vomiting, headache, foamy urine) and importance of informing a clinician if any unusual symptom develops or if any known symptom persists or worsens.¹

  
  


• 
  

  Importance of informing clinicians of existing or contemplated concomitant therapy, including prescription and OTC drugs, and any concomitant illnesses.¹

  
  


• 
  

  Importance of women informing clinicians if they are or plan to become pregnant or plan to breast-feed.¹ Advise women of childbearing potential about potential risk of fetal harm if telavancin is used during pregnancy.¹ (See Pregnancy under Cautions.)

  
  


• 
  

  Importance of excluding pregnancy with a serum pregnancy test before starting telavancin.¹ Advise women of childbearing potential to use effective contraception to prevent pregnancy during telavancin therapy and to notify a clinician if pregnancy occurs during telavancin therapy.¹ (See Pregnancy under Cautions.)

  
  


• 
  

  Importance of informing patients of other important precautionary information.¹ (See Cautions.)

  
  

Preparations

Excipients in commercially available drug preparations may have clinically important effects in some individuals; consult specific product labeling for details.

Telavancin Hydrochloride

Routes	Dosage Forms	Strengths	Brand Names	Manufacturer
Parenteral	For injection, for IV infusion	250 mg (of telavancin)	Vibativ	Theravance
		750 mg (of telavancin)	Vibativ	Theravance

Disclaimer

This report on medications is for your information only, and is not considered individual patient advice. Because of the changing nature of drug information, please consult your physician or pharmacist about specific clinical use.

The American Society of Health-System Pharmacists, Inc. and Drugs.com represent that the information provided hereunder was formulated with a reasonable standard of care, and in conformity with professional standards in the field. The American Society of Health-System Pharmacists, Inc. and Drugs.com make no representations or warranties, express or implied, including, but not limited to, any implied warranty of merchantability and/or fitness for a particular purpose, with respect to such information and specifically disclaims all such warranties. Users are advised that decisions regarding drug therapy are complex medical decisions requiring the independent, informed decision of an appropriate health care professional, and the information is provided for informational purposes only. The entire monograph for a drug should be reviewed for a thorough understanding of the drug's actions, uses and side effects. The American Society of Health-System Pharmacists, Inc. and Drugs.com do not endorse or recommend the use of any drug. The information is not a substitute for medical care.

AHFS Drug Information. © Copyright, 1959-2011, Selected Revisions October 27, 2011. American Society of Health-System Pharmacists, Inc., 7272 Wisconsin Avenue, Bethesda, Maryland 20814.

References

1. Theravance. Vibativ (telavancin) for injection prescribing information. South San Francisco, CA; 2009 Sep.

2. Stryjewski ME, Graham DR, Wilson SE et al. Telavancin versus vancomycin for the treatment of complicated skin and skin-structure infections caused by gram-positive organisms. Clin Infect Dis. 2008; 46:1683-93. [PubMed 18444791]

3. Stryjewski ME, Chu VH, O'Riordan WD et al. Telavancin versus standard therapy for treatment of complicated skin and skin structure infections caused by gram-positive bacteria: FAST 2 study. Antimicrob Agents Chemother. 2006; 50:862-7. [PubMed 16495243]

4. Shaw JP, Seroogy J, Kaniga K et al. Pharmacokinetics, serum inhibitory and bactericidal activity, and safety of telavancin in healthy subjects. Antimicrob Agents Chemother. 2005; 49:195-201. [PubMed 15616296]

5. Dunbar LM, Tang DM, Manausa RM. A review of telavancin in the treatment of complicated skin and skin structure infections (cSSSI). Ther Clin Risk Manag. 2008; 4:235-44. [PubMed 18728713]

6. Lin G, Pankuch GA, Ednie LM et al. Antistaphylococcal activity of telavancin tested alone and in combination by time-kill assay. Antimicrob Agents Chemother. 2010; :.

7. Wong SL, Goldberg MR, Ballow CH et al. Effect of Telavancin on the pharmacokinetics of the cytochrome P450 3A probe substrate midazolam: a randomized, double-blind, crossover study in healthy subjects. Pharmacotherapy. 2010; 30:136-43. [PubMed 20099988]

8. Goldberg MR, Wong SL, Shaw JP et al. Lack of effect of moderate hepatic impairment on the pharmacokinetics of telavancin. Pharmacotherapy. 2010; 30:35-42. [PubMed 20030471]

9. Wong SL, Sörgel F, Kinzig M et al. Lack of pharmacokinetic drug interactions following concomitant administration of telavancin with aztreonam or piperacillin/tazobactam in healthy participants. J Clin Pharmacol. 2009; 49:816-23. [PubMed 19443680]

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13. Gerding DN, Johnson S, Peterson LR et al for the Society for Healthcare Epidemiology of America. Position paper on Clostridium difficile-associated diarrhea and colitis. Infect Control Hosp Epidemiol. 1995; 16:459-77. [PubMed 7594392]

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15. American Society of Health-System Pharmacists Commission on Therapeutics. ASHP therapeutic position statement on the preferential use of metronidazole for the treatment of Clostridium difficile-associated disease. Am J Health-Syst Pharm. 1998; 55:1407-11. [IDIS 407213] [PubMed 9659970]

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17. NDA 22-110 Vibativ (telavancin) risk evaluation and mitigation strategy (REMS). From FDA website.

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