Nedocromil Sodium

Class: Mast-cell Stabilizers
ATC Class: R01AC07
VA Class: RE101
Chemical Name: 9-Ethyl-6,9-dihydro-4,6-dioxo-10-propyl-4H-pyrano(3,2-g)quinoline-2,8-dicarboxylic acid disodium salt
Molecular Formula: C₁₉H₁₇NO₇•2Na
CAS Number: 69049-74-7
Brands: Tilade

Introduction

Mast cell stabilizer; a pyranoquinoline dicarboxylic acid derivative.^{1 2 3 4 5 6 7 9 10 11 1 2 3 9 10 11}

Uses for Nedocromil Sodium

Asthma

Used as an adjunct in the overall management of mild to moderate bronchial asthma.^{1 2 3 4 5 9 10 11 a}

For prophylaxis only; not indicated for reversal of acute bronchospasm, including status asthmaticus.^{a 1 9 10} (See Acute Bronchospasm under Warnings.)

Nedocromil Sodium Dosage and Administration

General

• 
  

  Initially, administer concurrently with patient’s existing maintenance dosages of β-adrenergic agonists, theophylline, and/or corticosteroids.^{a 1 2 4 5} Once clinical response is observed and asthma adequately controlled, gradual reduction in concomitant therapy may be possible.^{a 1 2 4 5}

  
  

Administration

Oral Inhalation

Administer by oral inhalation using an oral aerosol inhaler.¹

Shake inhaler well before use.^{1 8} Actuate aerosol inhaler 3 times prior to the initial use or if it has not been used for >7 days.^a

Exhale slowly and completely, invert the inhaler, place the mouthpiece of the inhaler well into the mouth, and close the lips around it.⁸ Inhale slowly and deeply through the mouth while actuating the inhaler.⁸ Hold breath for 5–10 seconds, withdraw the mouthpiece, and exhale slowly.^{2 8}

Avoid spraying in eyes.^a

Clean inhaler twice weekly. Remove metal canister and cap and rinse plastic mouthpiece in hot running water. Allow to dry overnight in a warm place.^{a 8}

Optimal therapeutic effect is dependent upon administration at regular intervals, even during symptom-free periods.^a

Dosage

Available as nedocromil sodium, dosage expressed in terms of the salt.^{a 1}

The dose of nedocromil sodium is expressed as the amount delivered from the actuator of the inhaler per metered spray.^a

Oral inhalation aerosol delivers 2 mg from the valve and 1.75 mg from the actuator per metered spray.^a Each aerosol canister delivers ≥104 metered sprays.^{a 1}

Pediatric Patients

Asthma

Oral Inhalation

Children ≥6 years of age: 3.5 mg (2 inhalations) 4 times daily at regular intervals (14 mg/day).¹

Less frequent administration may be effective if asthma is well controlled at this dose (e.g., patients only need occasional β-agonist therapy and are not experiencing serious exacerbations).^a

Adults

Asthma

Oral Inhalation

3.5 mg (2 inhalations) 4 times daily at regular intervals (14 mg/day).¹

Less frequent administration may be effective if asthma is well controlled at this dose (e.g., patients only need occasional β-agonist therapy and are not experiencing serious exacerbations).^a

Prescribing Limits

Pediatric Patients

Asthma

Oral Inhalation

Children ≥6 years of age: Maximum 3.5 mg (2 inhalations) 4 times daily (14 mg/day).¹

Adults

Asthma

Oral Inhalation

Maximum 3.5 mg (2 inhalations) 4 times daily (14 mg/day).^{a 1}

Special Populations

No special population dosage recommendations at this time.^a

Cautions for Nedocromil Sodium

Contraindications

Known hypersensitivity to nedocromil or any ingredient in the formulation.^a

Warnings/Precautions

Warnings

Acute Bronchospasm

Nedocromil is not a bronchodilator; do not use for reversal of acute bronchospasm, especially status asthmaticus.^{1 9 10 a}

Use should generally be continued during acute exacerbations, unless patient becomes intolerant to use of inhaled dosage forms.^a

Bronchospasm, possibly life-threatening, may occur immediately after administration.^a If this occurs, discontinue nedocromil and institute alternative therapy.^a

General Precautions

Concomitant Corticosteroid Dosage

Role of nedocromil as a corticosteroid-sparing agent in patients receiving oral or inhaled corticosteroids not defined.^a Monitor patients closely if systemic or inhaled corticosteroids are reduced.^a

Specific Populations

Pregnancy

Category B.^a

Lactation

Not known if nedocromil is distributed into milk.^a Caution is advised if nedocromil is used.^a

Pediatric Use

Safety and efficacy not established in children <6 years of age.^a

Common Adverse Effects

Unpleasant taste, coughing, pharyngitis, rhinitis, upper respiratory infection, dyspnea, bronchospasm, sinusitis, nausea, vomiting, headache, chest pain, fever, viral infection.^a

Interactions for Nedocromil Sodium

No formal drug interaction studies to date.^a

Nedocromil Sodium Pharmacokinetics

Absorption

Bioavailability

Absolute bioavailability is 8 and 17% for single and multiple inhaled doses, respectively.^a

Onset

Full therapeutic effect may not be obtained for ≥1 week.^a

Distribution

Plasma Protein Binding

89%.^a

Elimination

Elimination Route

Excreted principally in urine as unchanged drug.^a

Half-life

3.3 hours.^a

Special Populations

Pharmacokinetics in children 6–11 years of age appear similar to those in adults.^a

Stability

Storage

Oral Inhalation

Aerosol, Solution for Inhalation

2–30°C.^a Do not freeze.^a

Temperatures >120°F may cause aerosol canister to burst.^a

Actions

• 
  

  Inhibits acute bronchoconstrictor response and delayed inflammatory response.^{a 1 2 6 9 10 11}

  
  


• 
  

  In vitro, inhibits eosinophils, neutrophils, macrophages, mast cells, monocytes, platelets,^{a 1 2 3 9 10 11} histamine, leukotriene C₄, and prostaglandin D₂.^{a 1 2 3 5 6}

  
  


• 
  

  Inhibits bronchoconstriction caused by sulfur dioxide, inhaled neurokinin A, various antigens, exercise, cold air, fog, and adenosine monophosphate.^a

  
  


• 
  

  Exhibits no bronchodilator, antihistamine, or corticosteroid activity.^a

  
  


• 
  

  Exhibits cough suppression resulting from inhibition of neuronal reflexes in airways.^{2 6 9 10}

  
  

Advice to Patients

• 
  

  Importance of providing patient a copy of manufacturer’s patient information.^a

  
  


• 
  

  Importance of adequate understanding of proper storage, preparation, disposal, and inhalation technique.^a

  
  


• 
  

  Importance of adherence to dosing schedules, even during symptom-free periods, and of not changing dose unless otherwise instructed by a clinician.^a

  
  


• 
  

  Importance of notifying physician immediately if symptoms do not improve or condition worsens.^a

  
  


• 
  

  Importance of women informing clinicians if they are or plan to become pregnant or plan to breast-feed.^a

  
  


• 
  

  Importance of informing clinicians of existing or contemplated concomitant therapy, including prescription and OTC drugs.^a

  
  


• 
  

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

  
  

Preparations

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

Nedocromil Sodium

Routes	Dosage Forms	Strengths	Brand Names	Manufacturer
Oral Inhalation	Aerosol	1.75 mg/metered spray (from the mouthpiece)	Tilade Inhaler (with chlorofluorohydrocarbon propellants)	Monarch

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, 1959-2010, Selected Revisions May 2007. American Society of Health-System Pharmacists, Inc., 7272 Wisconsin Avenue, Bethesda, Maryland 20814.

References

1. Aventis. Tilade (nedocromil sodium) inhalation aerosol prescribing information. Kansas City, MO; 1999 Oct.

2. Gonzalez JP, Brogden RN. Nedocromil sodium: a preliminary review of its pharmacodynamic and pharmacokinetic properties, and therapeutic efficacy in the treatment of reversible obstructive airways disease. Drugs. 1987; 34:560-77. [IDIS 236663] [PubMed 2826101]

3. Rebuck AS, Kesten S, Boulet LP et al. A 3-month evaluation of the efficacy of nedocromil sodium in asthma: a randomized, double-blind, placebo-controlled trial of nedocromil sodium conducted by a Canadian multicenter study group. J Allergy Clin Immunol. 1990; 85:612-7. [IDIS 314389] [PubMed 2155958]

4. Callaghan B, Teo NC, Clancy L. Effects of the addition of nedocromil sodium to maintenance bronchodilator therapy in the management of chronic asthma. Chest. 1992; 101:787-92. [IDIS 293018] [PubMed 1311666]

5. Cherniack RM, Wasserman SI, Ramsdell JW et al. A double-blind multicenter group comparative study of the efficacy and safety of nedocromil sodium in the management of asthma. Chest. 1990; 97:1299-1306. [IDIS 289144] [PubMed 2161328]

6. Tandon MK. Double-blind crossover study of nedocromil sodium in partially reversible chronic obstructive airways disease. Chest. 1993; 103:105-10. [IDIS 308235] [PubMed 8380266]

7. Morton AR, Ogle SL, Fitch KD. Effects of nedocromil sodium, cromolyn sodium, and a placebo in exercise-induced asthma. Ann Allergy. 1992; 68:143-8. [IDIS 292497] [PubMed 1310834]

8. Fisons. Tilade (nedocromil sodium) inhalation aerosol patient information. (undated)

9. Anon. Nedocromil for asthma. Med Lett Drugs Ther. 1993; 35:62-3. [PubMed 8390598]

10. Parish RC, Miller LJ. Nedocromil sodium. Ann Pharmacother. 1993; 27:599-606. [IDIS 314179] [PubMed 8394165]

11. Lal S, Dorow PD, Venho KK et al. Nedocromil sodium is more effective than cromolyn sodium for the treatment of chronic reversible obstructive airway disease. Chest. 1993; 104:438-47. [IDIS 319804] [PubMed 8393398]

12. Fisons Pharmaceuticals, Rochester, NY: Personal communication.

13. National Asthma Education and Prevention Program. Expert panel report II: guidelines for the diagnosis and management of asthma. 1997 Feb.

14. Kemp JP. Comprehensive asthma management: guidelines for clinicians. J Asthma. 1998; 35:601-20. [PubMed 9860081]

15. Kemp JP. Guidelines update: where do the new therapies fit in the management of asthma? Drugs. 2000; 59(Suppl 1):23-8.

a. King Pharmaceuticals. Tilade (nedocromil sodium) inhalation aerosol prescribing information. Bristol, TN; 2004 July.

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• Nedocromil Sodium Use in Pregnancy & Breastfeeding
• Nedocromil Sodium Drug Interactions
• Nedocromil Sodium Support Group
• 0 Reviews for Nedocromil Sodium - Add your own review/rating

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• Asthma, Maintenance

Natural Vitamin Blend E-400IU

Generic Name: vitamin e (Oral route)

VYE-ta-min E

Commonly used brand name(s)

In the U.S.

• Alpha-E


• Aqua Gem-E


• Aquasol E


• D-Alpha Gems


• E-400


• E-600


• E-Gems


• Formula E 400


• Gamma E-Gems


• Gamma E Plus


• Key-E


• Natural Vitamin Blend E-400IU


• Nutr-E-Sol

Available Dosage Forms:

• Liquid


• Solution


• Tablet


• Capsule, Liquid Filled


• Tablet, Chewable


• Powder for Solution


• Capsule

Therapeutic Class: Nutritive Agent

Pharmacologic Class: Vitamin E (class)

Uses For Natural Vitamin Blend E-400IU

Vitamins are compounds that you must have for growth and health. They are needed in only small amounts and are available in the foods that you eat. Vitamin E prevents a chemical reaction called oxidation, which can sometimes result in harmful effects in your body. It is also important for the proper function of nerves and muscles.

Some conditions may increase your need for vitamin E. These include:

• Intestine disease


• Liver disease


• Pancreas disease


• Surgical removal of stomach

Increased need for vitamin E should be determined by your health care professional.

Infants who are receiving a formula that is not fortified with vitamin E may be likely to have a vitamin E deficiency. Also, diets high in polyunsaturated fatty acids may increase your need for vitamin E.

Claims that vitamin E is effective for treatment of cancer and for prevention or treatment of acne, aging, loss of hair, bee stings, liver spots on the hands, bursitis, diaper rash, frostbite, stomach ulcer, heart attacks, labor pains, certain blood diseases, miscarriage, muscular dystrophy, poor posture, sexual impotence, sterility, infertility, menopause, sunburn, and lung damage from air pollution have not been proven. Although vitamin E is being used to prevent certain types of cancer, there is not enough information to show that this is effective.

Lack of vitamin E is extremely rare, except in people who have a disease in which it is not absorbed into the body.

Vitamin E is available without a prescription.

Importance of Diet

For good health, it is important that you eat a balanced and varied diet. Follow carefully any diet program your health care professional may recommend. For your specific dietary vitamin and/or mineral needs, ask your health care professional for a list of appropriate foods. If you think that you are not getting enough vitamins and/or minerals in your diet, you may choose to take a dietary supplement.

Vitamin E is found in various foods including vegetable oils (corn, cottonseed, soybean, safflower), wheat germ, whole-grain cereals, and green leafy vegetables. Cooking and storage may destroy some of the vitamin E in foods.

Vitamin supplements alone will not take the place of a good diet and will not provide energy. Your body also needs other substances found in food such as protein, minerals, carbohydrates, and fat. Vitamins themselves often cannot work without the presence of other foods. For example, small amounts of fat are needed so that vitamin E can be absorbed into the body.

The daily amount of vitamin E needed is defined in several different ways.

• For U.S.—


• Recommended Dietary Allowances (RDAs) are the amount of vitamins and minerals needed to provide for adequate nutrition in most healthy persons. RDAs for a given nutrient may vary depending on a person's age, sex, and physical condition (e.g., pregnancy).


• Daily Values (DVs) are used on food and dietary supplement labels to indicate the percent of the recommended daily amount of each nutrient that a serving provides. DV replaces the previous designation of United States Recommended Daily Allowances (USRDAs).

• For Canada—


• Recommended Nutrient Intakes (RNIs) are used to determine the amounts of vitamins, minerals, and protein needed to provide adequate nutrition and lessen the risk of chronic disease.

Vitamin E is available in various forms, including d- or dl-alpha tocopheryl acetate, d- or dl-alpha tocopherol, and d- or dl-alpha tocopheryl acid succinate. In the past, the RDA for vitamin E have been expressed in Units. This term has been replaced by alpha tocopherol equivalents (alpha-TE) or milligrams (mg) of d-alpha tocopherol. One Unit is equivalent to 1 mg of dl-alpha tocopherol acetate or 0.6 mg d-alpha tocopherol. Most products available in stores continue to be labeled in Units.

Normal daily recommended intakes in milligrams (mg) of alpha tocopherol equivalents (mg alpha-TE) and Units for vitamin E are generally defined as follows:

Persons	U.S.		Canada
	mg alpha-TE	Units	mg alpha-TE	Units
Infants and children Birth to 3 years of age	3–6	5–10	3–4	5–6.7
4 to 6 years of age	7	11.7	5	8.3
7 to 10 years of age	7	11.7	6–8	10–13
Adolescent and adult males	10	16.7	6–10	10–16.7
Adolescent and adult females	8	13	5–7	8.3–11.7
Pregnant females	10	16.7	8–9	13–15
Breast-feeding females	11–12	18–20	9–10	15–16.7

Before Using Natural Vitamin Blend E-400IU

If you are taking this dietary supplement without a prescription, carefully read and follow any precautions on the label. For this supplement, 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

Problems in children have not been reported with intake of normal daily recommended amounts. You should check with your health care professional if you are giving your baby an unfortified formula. In that case, the baby must get the vitamins needed some other way. Some studies have shown that premature infants may have low levels of vitamin E. Your health care professional may recommend a vitamin E supplement.

Geriatric

Problems in older adults have not been reported with intake of normal daily recommended amounts.

Pregnancy

	Pregnancy Category	Explanation
All Trimesters	A	Adequate studies in pregnant women have not shown an increased risk of fetal abnormalities.

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 dietary supplement, 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 dietary supplement 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.

• Dicumarol

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

• Bleeding problems—Vitamin E, when taken in doses greater than 800 Units a day for long periods of time, may make this condition worse

Proper Use of vitamin e

This section provides information on the proper use of a number of products that contain vitamin e. It may not be specific to Natural Vitamin Blend E-400IU. Please read with care.

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 solution dosage form:
  
  • To prevent the following deficiencies in infants:
    
    • Infants receiving a formula high in polyunsaturated fatty acids—15 to 25 Units per day or 7 Units per 32 ounces of formula.
    
    
    • Infants with certain colon problems—15 to 25 Units per kilogram (kg) (6.8 to 11 Units per pound) of body weight per day. The water-soluble form of vitamin E must be used.
    
    
    • Infants of normal birthweight—5 Units per 32 ounces of formula.
    
    
  
  


• For oral dosage forms (capsules, tablets, oral solution):
  
  • To prevent deficiency for individuals (other than infants), the amount taken by mouth is based on normal daily recommended intakes:
    
    • For the U.S.
    
    
    • Adult and teenage males—10 milligrams (mg) of alpha tocopherol equivalents (mg alpha-TE) or 16.7 Units per day.
    
    
    • Adult and teenage females—8 mg alpha-TE or 13 Units per day.
    
    
    • Pregnant females—10 mg alpha-TE or 16.7 Units per day.
    
    
    • Breast-feeding females—11 to 12 mg alpha-TE or 18 to 20 Units per day.
    
    
    • Children 4 to 10 years of age—7 mg alpha-TE or 11.7 Units per day.
    
    
    • Children birth to 3 years of age—3 to 6 mg alpha-TE or 5 to 10 Units per day.
    
    
    • For Canada
    
    
    • Adult and teenage males—6 to 10 mg alpha-TE or 10 to 16.7 Units per day.
    
    
    • Adult and teenage females—5 to 7 mg alpha-TE or 8.3 to 11.7 Units per day.
    
    
    • Pregnant females—8 to 9 mg alpha-TE or 13 to 15 Units per day.
    
    
    • Breast-feeding females—9 to 10 mg alpha-TE or 15 to 16.7 Units per day.
    
    
    • Children 7 to 10 years of age—6 to 8 mg alpha-TE or 10 to 13 Units per day.
    
    
    • Children 4 to 6 years of age—5 mg alpha-TE or 8.3 Units per day.
    
    
    • Children birth to 3 years of age—3 to 4 mg alpha-TE or 5 to 6.7 Units per day.
    
    
  
  
  • To treat deficiency:
    
    • Adults, teenagers, and children—Treatment dose is determined by prescriber for each individual based on the severity of deficiency.
    
    
  
  

For individuals taking the oral liquid form of this dietary supplement:

• This preparation should be taken by mouth even though it comes in a dropper bottle.


• This dietary supplement may be dropped directly into the mouth or mixed with cereal, fruit juice, or other food.

Missed Dose

If you miss a dose of this medicine, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage

Store the dietary supplement 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.

Natural Vitamin Blend E-400IU 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 as soon as possible if any of the following side effects occur:

With doses greater than 400 Units a day and long-term use

• Blurred vision


• diarrhea


• dizziness


• headache


• nausea or stomach cramps


• unusual tiredness or weakness

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

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

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

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

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• 2 Reviews for Natural Vitamin Blend E-400IU - Add your own review/rating

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• Alzheimer's Disease
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Natrecor

Generic Name: nesiritide (Intravenous route)

ne-SIR-i-tide

Commonly used brand name(s)

In the U.S.

• Natrecor

Available Dosage Forms:

• Powder for Solution

Therapeutic Class: Cardiovascular Agent

Pharmacologic Class: Natriuretic Peptide

Uses For Natrecor

Nesiritide is used for patients who have severe congestive heart failure that has recently become worse. Nesiritide is for patients who are short of breath while at rest or with minimal activity.

Before Using Natrecor

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

Studies on this medicine have been done only in adult patients, and there is no specific information comparing use of nesiritide in children with use in other age groups.

Geriatric

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

Pregnancy

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

Breast Feeding

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

Interactions with Medicines

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. 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 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.

• Benazepril


• Captopril


• Cilazapril


• Enalapril Maleate


• Fosinopril


• Lisinopril


• Quinapril


• Ramipril


• Zofenopril

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:

• Heart disease (other than congestive heart failure)—Nesiritide may make heart problems worse.

• Low blood pressure—Nesiritide may make this condition worse.

Proper Use of Natrecor

Dosing

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

• For injection dosage form:
  
  • For congestive heart failure:
    
    • Adults—Dose is based on your weight and must be determined by your doctor.
    
    
    • Children—Use and dose must be determined by your doctor.
    
    
  
  

Natrecor 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

• Low blood pressure

Less common

• Bluish lips or skin


• chest pain, tightness, or discomfort


• cool, clammy skin


• difficulty in breathing or shortness of breath


• dizziness


• fainting


• lightheadedness


• fast, slow, or irregular heartbeat


• unusual tiredness or weakness

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

• Headache

Less common

• Abdominal or stomach pain


• anxiety


• back pain


• burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings on the skin


• change in vision


• confusion


• coughing or spitting up blood


• fever


• increased cough


• itching skin


• leg cramps


• nausea


• pain or irritation at the injection site


• pale skin, unusual bleeding or bruising


• rash


• sleepiness or unusual drowsiness


• sleeplessness


• sweating


• trembling or shakiness


• vomiting

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: Natrecor 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 Natrecor resources

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

• Natrecor Prescribing Information (FDA)


• Natrecor Consumer Overview


• Natrecor Monograph (AHFS DI)


• Natrecor MedFacts Consumer Leaflet (Wolters Kluwer)


• Nesiritide Professional Patient Advice (Wolters Kluwer)

Compare Natrecor with other medications

• Heart Failure

Natrecor

Generic Name: Nesiritide
Class: Vasodilating Agents, Miscellaneous
VA Class: CV900
Chemical Name: Natriuretic factor-32 (human brain clone λhBNP57)
Molecular Formula: C₁₄₃H₂₄₄N₅₀O₄₂S₄
CAS Number: 124584-08-3

Introduction

Vasodilator; a biosynthetic (recombinant DNA origin) form of human B-type natriuretic peptide (BNP).^{1 4 7 8}

Uses for Natrecor

Decompensated Congestive Heart Failure

Used alone or in conjunction with other standard therapies (e.g., diuretics, cardiac glycosides) for treatment of patients with acutely decompensated CHF who have dyspnea at rest or with minimal activity (i.e., NYHA class IV symptoms).^{1 2 5 7 8 9}

Ability to improve overall clinical status and symptoms of decompensated CHF (e.g., dyspnea, fatigue) may be comparable to that of standard IV therapy (principally dobutamine, milrinone, or nitroglycerin).^{2 7 9} However, until more data are available, some clinicians suggest reserving nesiritide for use in patients who do not respond to nitroglycerin or who cannot be treated with sodium nitroprusside.⁹

Manufacturer recommends strictly limiting use to patients with acutely decompensated CHF whose manifestations warrant hospitalization or management in emergency department.¹⁴

Manufacturer does not recommend use of intermittent, serial, or scheduled repetitive infusions in an outpatient setting for treatment of severe CHF.¹⁴ Clinical studies are ongoing.^{14 15}

Manufacturer does not recommend use as replacement therapy for diuretics, to improve renal function, and/or to enhance diuresis.¹⁴ Use is associated with dose-dependent elevations in S_cr.^{1 10 12 13 14} (See Renal Effects under Cautions.)

Natrecor Dosage and Administration

General

• 
  

  Administer only in settings where BP can be closely monitored; no specific need for arterial catheters, pulmonary artery catheters, or telemetry.^{1 7 14}

  
  

Administration

Administer IV loading dose followed by continuous IV infusion.^{1 7}

IV Administration

For solution and drug compatibility information, see Compatibility under Stability.

Reconstituted solutions contain no preservatives; solutions preferably should be prepared immediately before use.⁷

Prime IV tubing with 5 mL of diluted nesiritide solution prior to connecting the tubing to the patient’s vascular access port and prior to administering the loading dose or starting the infusion.^{1 7}

Withdraw loading dose from the infusion bag containing diluted nesiritide solution and administer through port in IV infusion set; continuous infusion should follow immediately.^{1 7}

Do not administer through a central catheter coated with heparin, since nesiritide binds to heparin.¹

Reconstitution

Remove 5 mL of a preservative-free diluent (see Solution Compatibility under Stability) from a prefilled 250-mL infusion bag and add the 5 mL of diluent to a vial labeled as containing 1.5 mg of nesiritide.^{1 7} Swirl vial gently to ensure dissolution; do not shake.^{1 7}

Dilution

Following reconstitution, add entire contents of the vial to the original 250-mL infusion bag, to yield a final nesiritide concentration of approximately 6 mcg/mL; invert bag several times to ensure complete mixing.^{1 7}

Rate of Administration

Administer loading dose over approximately 60 seconds followed immediately by continuous IV infusion of nesiritide (6 mcg/mL) at a rate of 0.1 mL/kg per hour (approximately 0.01 mcg/kg per minute).^{1 7}

The volume of diluted (6 mcg/mL) solution needed to administer a 2-mcg/kg loading dose can be calculated by using the following formula or can be obtained from the following table:^{1 7}

Loading dose volume (in mL) = patient weight (in kg) / 3

Patient Weight (kg)	Loading Dose Volume (mL)
60	20
70	23.3
80	26.7
90	30
100	33.3
110	36.7

The rate (in mL/hr) at which the diluted (6 mcg/mL) solution must be infused to deliver a dosage of 0.01 mcg/kg per minute can be calculated by using the following formula or can be obtained from the following table:^{1 7}

Continuous infusion rate (in mL/hr) = patient weight (in kg) × 0.1

Patient Weight (kg)	Continuous Infusion Rate (mL/hr)
60	6
70	7
80	8
90	9
100	10
110	11

Dosage

Because of the possibility of dose-related episodes of severe and/or protracted hypotension, do not initiate nesiritide at higher than recommended dosages.^{1 7}

Do not titrate at frequent intervals.^{1 7 10}

Adults

Decompensated Congestive Heart Failure

IV

Loading dose of 2 mcg/kg over approximately 60 seconds, followed immediately by continuous infusion of 0.01 mcg/kg per minute.^{1 7}

In VMAC study, infusion rate was increased in increments of 0.005 mcg/kg per minute, no more frequently than every 3 hours up to a maximum dosage of 0.03 mcg/kg per minute, in a limited number of patients receiving invasive hemodynamic monitoring.^{1 7}

If hypotension occurs, reduce dosage or discontinue drug and institute supportive measures (e.g., IV fluids, changes in body position).^{1 7 10} In VMAC study, nesiritide could be reinitiated without a loading dose and with a 30% reduction in infusion rate following observation and stabilization of patient.^{1 7}

Prescribing Limits

Adults

IV

Maximum 0.03 mcg/kg per minute.^{1 7}

Limited experience with infusions lasting >48 hours.¹ In clinical studies, 48% of patients received nesiritide for 24–48 hours.¹

Cautions for Natrecor

Contraindications

• 
  

  Known hypersensitivity to nesiritide or any ingredient in the formulation.¹

  
  


• 
  

  Should not be used as primary therapy for patients with cardiogenic shock or in those with SBP of <90 mm Hg.^{1 7 10}

  
  

Warnings/Precautions

Warnings

Concomitant Cardiac Disorders

Use not recommended in patients with known or suspected low cardiac filling pressures or in those for whom vasodilating agents are not appropriate (e.g., patients with substantial valvular stenosis, restrictive or obstructive cardiomyopathy, constrictive pericarditis, pericardial tamponade, or other conditions in which cardiac output depends on venous return).^{1 10}

Sensitivity Reactions

Hypersensitivity Reactions

Risk of allergic reaction with parenteral administration of proteins or Escherichia coli-derived products; however, no serious allergic or anaphylactic reactions reported to date with nesiritide.^{1 10}

General Precautions

Risk of Mortality

Pooled analyses of data from controlled clinical trials indicate numerical, but not statistically significant, increases in 30-day mortality with nesiritide compared with other therapies (generally nitroglycerin and diuretics).^{1 10 11 14} Mortality rates of 5.3 versus 4.3%^{1 10 14} and of 7.2 versus 4%¹¹ have been reported for nesiritide compared with other therapies, depending on study-selection criteria.^{1 10 11 14}

Mortality rates at 180 days: Pooled analyses of data from controlled clinical trials indicate mortality rates of 21.7% (nesiritide) or 21.5% (other therapies).^{1 10 14}

Current analyses are limited by potential confounding factors (e.g., baseline differences between treatment groups), study size (e.g., small studies with few patient deaths), and other limitations inherent in pooled analyses of existing trials.^{1 10 11 14} Adequate, prospective clinical studies are needed to determine whether nesiritide is associated with an increased risk of death in patients with acutely decompensated CHF.^{1 10 11 14}

Hypotensive Effects

Incidence of symptomatic hypotension in initial 24 hours of therapy similar with nesiritide or IV nitroglycerin (4 or 5%, respectively), but more prolonged with nesiritide (mean duration: 2.2 hours) than with nitroglycerin (mean duration: 0.7 hour).^{1 7 9 10}

Higher dosages have been associated with increased risk of hypotension.^{1 7 10 14}

If hypotension occurs, institute supportive measures (e.g., IV fluids).¹ Dosage reduction or drug discontinuance may be required.^{1 7 10}

Use with caution in patients with baseline SBP of <100 mm Hg and in those receiving other hypotensive agents concomitantly.^{1 7} (See Specific Drugs under Interactions.)

Renal Effects

Possible worsening of renal function in susceptible patients.^{1 10 12 13 14} Not known whether worsening renal function reflects hemodynamic effects or renal injury; further study is needed.^{10 12 13 14}

Possible azotemia in patients with severe CHF whose renal function depends on activity of the renin-angiotensin-aldosterone system.^{1 10 12 13 14}

Higher dosages have been associated with increased risk of elevated S_cr.^{7 10 14}

Specific Populations

Pregnancy

Category C.¹

Lactation

Not known whether nesiritide is distributed into milk;¹ use with caution in nursing women.¹

Pediatric Use

Safety and efficacy not established in children <18 years of age.^{1 7}

Geriatric Use

No substantial differences in safety and efficacy relative to younger adults, but increased sensitivity cannot be ruled out.¹

Common Adverse Effects

Hypotension,^{1 7 10} ventricular tachycardia,^{1 7 10} ventricular extrasystoles,^{1 7} angina pectoris,¹ bradycardia,¹ headache,^{1 7 10} insomnia,¹ abdominal pain,^{1 14} back pain,^{1 7} dizziness,^{1 7} anxiety,^{1 7} nausea,^{1 7 10} vomiting.¹

Interactions for Natrecor

No formal drug interaction studies to date.^{1 7} However, concomitant use of other cardiovascular agents (except IV vasodilators [e.g., nitroglycerin, sodium nitroprusside, milrinone] and IV ACE inhibitors) was allowed in clinical studies.^{1 7}

Specific Drugs

Drug	Interaction
ACE inhibitors	Increased incidence of symptomatic hypotension1 Pharmacokinetic interaction unlikely1
Angiotensin II receptor antagonists	May increase risk of hypotension1
Antiarrhythmic agents (class III)	Pharmacokinetic interaction unlikely1
Anticoagulants	Pharmacokinetic interaction unlikely1
β-Adrenergic blocking agents	May increase risk of hypotension1
Calcium-channel blocking agents	May increase risk of hypotension1
Digoxin	Pharmacokinetic interaction unlikely1
Diuretics	May increase risk of hypotension1
Dobutamine	Pharmacokinetic interaction unlikely1
HMG-CoA reductase inhibitor [statin] antilipemic agents	Pharmacokinetic interaction unlikely1
Hypotensive agents	May increase risk of hypotension1
Nitrates (oral)	Pharmacokinetic interaction unlikely1

Natrecor Pharmacokinetics

Elimination

Elimination Route

Binding to cell surface clearance receptors with subsequent cellular internalization and lysosomal proteolysis; proteolytic cleavage of the peptide by endopeptidases (e.g., neutral endopeptidase) on the vascular lumenal surface; and renal filtration.¹

Half-life

Biphasic; mean initial-phase and terminal-phase half-lives of approximately 2 and 18 minutes, respectively.¹

Stability

Storage

Parenteral

Powder for Injection

20–25°C (may be exposed to temperatures ranging from 15–30°C).¹

Store reconstituted solution at 20–25°C or refrigerate at 2–8°C; use up to 24 hours after reconstitution.^{1 7}

Compatibility

For information on systemic interactions resulting from concomitant use, see Interactions.

Parenteral

Solution Compatibility

Compatible1
Dextrose 5% in water
Dextrose 5% and 0.2 or 0.45% sodium chloride
Sodium chloride 0.9%

Drug Compatibility

Incompatible with drugs that contain the preservative sodium metabisulfite.¹

Y-site Compatibility1

Incompatible
Bumetanide
Enalaprilat
Ethacrynate sodium
Furosemide
Heparin
Hydralazine hydrochloride
Insulin

ActionsActions

• 
  

  A vasodilator that is structurally and pharmacologically identical to endogenous BNP,^{1 4 7 8} the principal natriuretic peptide responsible for maintaining normal fluid and sodium homeostasis in patients with CHF.⁸

  
  


• 
  

  Produces dose-dependent reductions in pulmonary capillary wedge pressure and systemic arterial pressure and has modest diuretic and natriuretic effects in patients with CHF.^{1 4 7 8 9}

  
  


• 
  

  Proarrhythmic effects have not been observed in patients with decompensated CHF receiving nesiritide.^{3 4 7}

  
  

Advice to Patients

• 
  

  Risk of symptomatic hypotension.^{1 7}

  
  


• 
  

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

  
  


• 
  

  Importance of women informing clinicians if they are or plan to become pregnant or plan to breast-feed.¹

  
  


• 
  

  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.

Nesiritide

Routes	Dosage Forms	Strengths	Brand Names	Manufacturer
Parenteral	For injection, for IV infusion	1.5 mg	Natrecor	Scios

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 May 2006. American Society of Health-System Pharmacists, Inc., 7272 Wisconsin Avenue, Bethesda, Maryland 20814.

References

1. Scios Inc. Natrecor (nesiritide) for injection prescribing information. Fremont, CA; 2005 Apr.

2. Colucci WS, Elkayam U, Horton DP et al. Intravenous nesiritide, a natriuretic peptide, in the treatment of decompensated congestive heart failure. N Engl J Med. 2000; 343:246-53. [IDIS 450037] [PubMed 10911006]

3. Burger AJ, Dennish G III, Dinerman J et al. Nesiritide therapy for decompensated CHF is not proarrhythmic. PRECEDENT study. Paper presented at 3rd scientific meeting of the Heart Failure Society of America. San Francisco, CA: 1999; Sept 22-25. (Abstract revision 1, 2000 Jul 27).

4. Colucci WS. Nesiritide for the treatment of decompensated heart failure. J Card Fail. 2001; 7:92-100. [PubMed 11264555]

5. Young, J. Vasodilation in the management of acute congestive heart failure (VMAC). Paper presented at 10th American Heart Association AHA) scientific sessions. New Orleans, LA: 2000; Nov 12-15. From the Medscape web site.

6. Silver MA, Ghali JK, Horton DP et al. Effect of nesiritide versus dobutamine on short-term outcomes in the treatment of acutely decompensated heart failure. J Card Fail. 1998; 4(Suppl 1):40. Abstract.

7. Scios, Sunnyvale, CA: Personal communication.

8. Hobbs RE, Mills RM, Young JB. An update on nesiritide for treatment of decompensated heart failure. Exp Opin Invest Drugs. 2001; 10:935-42.

9. Anon. Nesiritide for decompensated congestive heart failure. Med Lett Drugs Ther. 2001; 43:100-1.

10. Horton DP. Dear healthcare professional letter regarding important drug warning on Natrecor and possible adverse effects on survival and kidney function compared to control agents (e.g., nitroglycerin and diuretics). Scios Inc: Fremont, CA; 2005 May 6. From FDA web site. Accessed May 20, 2005.

11. Sackner-Bernstein JD, Kowalski M, Fox M et al. Short-term risk of death after treatment with nesiritide for decompensated heart failure: a pooled analysis of randomized controlled trials. JAMA. 2005; 293:1900-5.

12. Sackner-Bernstein JD, Skopicki HA, Aaronson KD. Risk of worsening renal function with nesiritide in patients with acutely decompensated heart failure. Circulation. 2005; 111:1487-91.

13. Teerlink JR, Massie BM. Nesiritide and worsening of renal function: the emperor’s new clothes? Circulation. 2005; 111:1459-61.

14. Horton DP. Dear healthcare professional letter regarding recommendations of an expert panel of cardiology and heart failure clinicians on the appropriate use of Natrecor (nesiritide) and the drug's effect on mortality and kidney function. Scios Inc: Fremont, CA; 2005 July 13. From FDA web site. Accessed Oct. 20, 2005.

15. Yancy CW. Treatment with B-type natriuretic peptide for chronic decompensated heart failure: insights learned from the follow-up serial infusion of nesiritide (FUSION) trial.Heart Fail Rev. 2004;9:209-16.

More Natrecor resources

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

• Natrecor Prescribing Information (FDA)


• Natrecor Consumer Overview


• Natrecor Advanced Consumer (Micromedex) - Includes Dosage Information


• Natrecor MedFacts Consumer Leaflet (Wolters Kluwer)


• Nesiritide Professional Patient Advice (Wolters Kluwer)

Compare Natrecor with other medications

• Heart Failure

nelfinavir

Generic Name: nelfinavir (nel FIN a veer)

Brand Names: Viracept

What is nelfinavir?

Nelfinavir is an antiviral medication in a group of HIV medicines called protease (PRO-tee-ayz) inhibitors. Nelfinavir prevents human immunodeficiency virus (HIV) cells from multiplying in your body.

Nelfinavir is used to treat HIV, which causes acquired immunodeficiency syndrome (AIDS). Nelfinavir is not a cure for HIV or AIDS.

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

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

A European version of nelfinavir was found to have high levels of an impurity known to cause cancer in animals. Nelfinavir in the U.S. was found to have lower levels of the impurity, which is created during the manufacturing process but can be minimized.

It is not known whether this impurity has caused harm to anyone taking nelfinavir, and it is important to keep treating your condition. Children and pregnant women should not take nelfinavir as a "first-line" treatment. If you already take nelfinavir your doctor may recommend that you keep taking it. Do not stop taking nelfinavir or change your dose without your doctor's advice.

Do not take nelfinavir with amiodarone (Cordarone, Pacerone), quinidine (Quinaglute, Quinidex), pimozide (Orap), midazolam (Versed), triazolam (Halcion), or an ergot medicine such as Ergomar, Cafergot, Wigraine, D.H.E. 45, Migranal, or Methergine. These drugs can cause life-threatening side effects if you use them while you are taking nelfinavir.

There are many other medicines that can interact with nelfinavir. Tell your doctor about all the prescription and over-the-counter medications you use. This includes vitamins, minerals, herbal products, and drugs prescribed by other doctors.

Taking this medication will not prevent you from passing HIV to other people. Talk with your doctor about safe methods of preventing HIV transmission during sex.

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

You should not take this medication if you are allergic to nelfinavir, or if you have severe liver or kidney disease.

Do not take nelfinavir with amiodarone (Cordarone, Pacerone), quinidine (Quinaglute, Quinidex), pimozide (Orap), midazolam (Versed), triazolam (Halcion), or an ergot medicine such as Ergomar, Cafergot, Wigraine, D.H.E. 45, Migranal, or Methergine. These medications can cause life-threatening side effects if you use them while you are taking nelfinavir.

If you have any of these other conditions, you may need a dose adjustment or special tests to safely take nelfinavir.

• liver disease;


• kidney disease;


• 
  

  diabetes;

  
  


• 
  

  a bleeding disorder such as hemophilia; or

  
  


• 
  

  high cholesterol or triglycerides.

  
  

FDA pregnancy category B. This medication is not expected to be harmful to an unborn baby, but HIV can be passed to the baby if the mother is not properly treated during pregnancy. Tell your doctor if you are pregnant or plan to become pregnant during treatment. Take all of your HIV medicines as directed to control your infection while you are pregnant. Nelfinavir can make birth control pills less effective. Ask your doctor about using a non-hormone method of birth control (such as a condom, diaphragm, spermicide) to prevent pregnancy while taking nelfinavir.

If you are pregnant, your name may need to be listed on an antiviral pregnancy registry when you start using this medication.

You should not breast-feed while you are using nelfinavir. Women with HIV or AIDS should not breast-feed at all. Even if your baby is born without HIV, you may still pass the virus to the baby in your breast milk. Do not give this medication to a child younger than 2 years old.

The powder form of nelfinavir may contain phenylalanine. Talk to your doctor before using this form of nelfinavir if you have phenylketonuria (PKU).

How should I take nelfinavir?

A European version of nelfinavir was found to have high levels of an impurity known to cause cancer in animals. This impurity is created during the manufacturing process but can be minimized. Nelfinavir in the U.S. is not made by the same manufacturer as the European version, and the U.S. version was found to have lower levels of the impurity.

It is not known whether this impurity has caused harm to anyone taking nelfinavir, and it is important to keep treating your condition. Children and pregnant women should not take nelfinavir as a "first-line" treatment. If you already take nelfinavir your doctor may recommend that you keep taking it. Do not stop taking nelfinavir or change your dose without your doctor's advice.

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

This medication comes with patient instructions for safe and effective use. Follow these directions carefully. Ask your doctor or pharmacist if you have any questions.

Take nelfinavir with a full glass (8 ounces) of water. Nelfinavir works best if you take it with food.

Swallow the nelfinavir tablet whole.

If you cannot swallow a whole tablet, dissolve it in a small amount of water. Stir this mixture and drink all of it right away. To make sure you get the entire dose, add a little more water to the same glass, swirl gently and drink right away.

A dose of nelfinavir powder must be mixed with liquid. You may use water, milk, formula, soy formula, soy milk, or a dietary supplement. Do not mix the powder with apple juice, orange juice, or other acidic juices or foods. Do not add the liquid directly to the bottle of nelfinavir powder.

Drink the mixture right away. If the mixture is not used right away, it may be stored in a refrigerator for up to 6 hours.

It is important to use nelfinavir regularly to get the most benefit. Get your prescription refilled before you run out of medicine completely.

HIV/AIDS is usually treated with a combination of different drugs. To best treat your condition, use all of your medications as directed by your doctor. Be sure to read the medication guide or patient instructions provided with each of your medications. Do not change your doses or medication schedule without advice from your doctor. Every person with HIV or AIDS should remain under the care of a doctor.

To be sure nelfinavir is helping your condition, your blood will need to be tested on a regular basis. Your liver function may also need to be tested. Do not miss any scheduled visits to your doctor.

Store nelfinavir at room temperature away from moisture and heat.

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, skip the missed dose and take the medicine at the next regularly scheduled time. 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. Symptoms of a nelfinavir overdose are not known.

What should I avoid while taking nelfinavir?

If you also take didanosine, take it 1 hour before or 2 hours after you take nelfinavir.

Avoid having unprotected sex or sharing needles, razors, or toothbrushes. Taking this medication will not prevent you from passing HIV to other people. Talk with your doctor about safe methods of preventing HIV transmission during sex. Sharing drug or medicine needles is never safe, even for a healthy person.

Nelfinavir side effects

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat. Stop taking nelfinavir and call your doctor at once if you have any of these serious side effects:

• 
  

  increased urination or extreme thirst;

  
  


• 
  

  easy bruising or bleeding; or

  
  


• 
  

  signs of a new infection, such as fever or chills, cough, or flu symptoms.

  
  

Less serious side effects may include:

• 
  

  nausea, vomiting, diarrhea, stomach pain, bloating, loss of appetite;

  
  


• 
  

  tired feeling;

  
  


• 
  

  headache, mood changes; or

  
  


• 
  

  changes in the shape or location of body fat (especially in your arms, legs, face, neck, breasts, and trunk).

  
  

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.

Nelfinavir Dosing Information

Usual Adult Dose for HIV Infection:

1250 mg orally every 12 hours (preferred regimen) or 750 mg every 8 hours

Usual Adult Dose for Nonoccupational Exposure:

1250 mg orally every 12 hours (preferred regimen) or 750 mg every 8 hours

Duration: Prophylaxis should be initiated as soon as possible, within 72 hours of exposure, and continued for 28 days.

In general, the alternative regimens recommended for nonoccupational postexposure HIV prophylaxis include nelfinavir as part of a protease inhibitor (PI)-based regimens.

Usual Adult Dose for Occupational Exposure:

1250 mg orally every 12 hours (preferred regimen) or 750 mg every 8 hours

Duration: Therapy should begin promptly, preferably within 1 to 2 hours postexposure and continued for 4 weeks. However, the exact duration of therapy may differ based the institution's protocol.

Usual Pediatric Dose for HIV Infection:

2 to 13 years of age: 45 to 55 mg/kg orally every 12 hours or 25 to 35 mg/kg every 8 hours
Maximum dose: 2500 mg/day

Oral powder (50 mg/g):
9 to less than 10.5 kg: 2.5 teaspoons (tsp) (10 scoops) orally every 12 hours or 1.5 tsp (6 scoops) every 8 hours
10.5 to less than 12 kg: 2.75 tsp (11 scoops) orally every 12 hours or 1.75 tsp (7 scoops) every 8 hours
12 to less than 14 kg: 3.25 tsp (13 scoops) orally every 12 hours or 2 tsp (8 scoops) every 8 hours
14 to less than 16 kg: 3.75 tsp (15 scoops) orally every 12 hours or 2.25 tsp (9 scoops) every 8 hours
16 to less than 18 kg: 2.5 tsp (10 scoops) orally every 8 hours
18 to less than 23 kg: 3 tsp (12 scoops) orally every 8 hours
23 kg or more: 3.75 tsp (15 scoops) orally every 8 hours
For twice daily dosing, nelfinavir tablets are recommended for children weighing 16 kg or more.

Crushed 250 mg tablets may be used instead of powder.

Tablets (250 mg):
10 to 12 kg: 500 mg orally every 12 hours or 250 mg every 8 hours
13 to 18 kg: 750 mg orally every 12 hours or 500 mg every 8 hours
19 to 20 kg: 1000 mg orally every 12 hours or 500 mg every 8 hours
21 kg or more: 1000 to 1250 mg orally every 12 hours or 750 mg every 8 hours

What other drugs will affect nelfinavir?

Before taking nelfinavir, tell your doctor if you are using any of the following drugs:

• 
  

  fluticasone (Advair, Flonase, Flovent);

  
  


• 
  

  itraconazole (Sporanox) or ketoconazole (Nizoral);

  
  


• 
  

  lopinavir/ritonavir (Kaletra);

  
  


• 
  

  methadone (Dolophine, Methadose);

  
  


• 
  

  omeprazole (Prilosec);

  
  


• 
  

  rifabutin (Mycobutin, or rifampin (Rifadin, Rimactane, Rifater);

  
  


• 
  

  St. John's wort;

  
  


• 
  

  antidepressants such as trazodone (Desyrel) and others;

  
  


• 
  

  a calcium channel blocker such as amlodipine (Caduet, Lotrel, Norvasc), diltiazem (Tiazac, Cartia, Dilacor), felodipine (Plendil), nifedipine (Procardia, Adalat), or verapamil (Calan, Covera, Isoptin, Verelan);

  
  


• 
  

  cholesterol-lowering medicine such as atorvastatin (Lipitor), lovastatin (Mevacor, Altocor), rosuvastatin (Crestor), or simvastatin (Zocor);

  
  


• 
  

  drugs that weaken the immune system, such as cyclosporine (Gengraf, Neoral, Sandimmune), sirolimus (Rapamune), or tacrolimus (Prograf);

  
  


• 
  

  insulin or diabetes medication you take by mouth;

  
  


• 
  

  medicines to treat erectile dysfunction, such as sildenafil (Viagra), tadalafil (Cialis), or vardenafil (Levitra); or

  
  


• 
  

  seizure medications such as carbamazepine (Carbatrol, Tegretol), phenobarbital (Luminal, Solfoton), or phenytoin (Dilantin).

  
  

This list is not complete and there are many other medicines that can interact with nelfinavir. Tell your doctor about all the prescription and over-the-counter medications you use. This includes vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start using a new medication without telling your doctor. Keep a list with you of all the medicines you use and show this list to any doctor or other healthcare provider who treats you.

More nelfinavir resources

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

• nelfinavir Advanced Consumer (Micromedex) - Includes Dosage Information


• Nelfinavir MedFacts Consumer Leaflet (Wolters Kluwer)


• Nelfinavir Mesylate Monograph (AHFS DI)


• Viracept Prescribing Information (FDA)


• Viracept Consumer Overview

Compare nelfinavir with other medications

• HIV Infection
• Nonoccupational Exposure
• Occupational Exposure

Where can I get more information?

• Your pharmacist can provide more information about nelfinavir.

See also: nelfinavir side effects (in more detail)

Nebupent

Generic Name: pentamidine (pen TAM e deen)

Brand Names: Nebupent, Pentam 300

What is Nebupent (pentamidine)?

Pentamidine is a type of antibiotic that fights protozoa in the body.

Pentamidine is used to prevent and treat serious infections such as Pneumocystis pneumonia.

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

What is the most important information I should know about Nebupent (pentamidine)?

Pentamidine may affect blood sugar levels. Contact your doctor if you experience any low blood sugar symptoms including

• 
  

  increased appetite;

  
  


• 
  

  headache;

  
  


• 
  

  chills, pale skin, shakes, cold sweats; or

  
  


• 
  

  anxiety.

  
  

Pentamidine may affect blood sugar levels. Contact your doctor if you experience any high blood sugar symptoms including

• 
  

  increased thirst;

  
  


• 
  

  loss of appetite;

  
  


• 
  

  increase in amount or frequency or urination;

  
  


• 
  

  fruity smelling breath; or

  
  


• 
  

  drowsiness.

  
  

Your doctor may want you to have regular blood, heart function, and blood sugar evaluations during treatment with pentamidine to monitor progress and side effects.

What should I discuss with my healthcare provider before taking Nebupent (pentamidine)?

Before taking this medication, tell your doctor if you have:

• 
  

  diabetes;

  
  


• 
  

  heart problems

  
  


• 
  

  blood pressure or circulation problems;

  
  


• 
  

  kidney disease;

  
  


• 
  

  pancreatitis;

  
  


• 
  

  asthma;

  
  


• 
  

  recent radiation therapy or treatment with chemotherapy;

  
  


• 
  

  a history of dehydration; or

  
  


• 
  

  special dietary restrictions.

  
  

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

Pentamidine may affect blood sugar levels. Contact your doctor if you experience any low blood sugar symptoms including

• 
  

  increased appetite;

  
  


• 
  

  headache;

  
  


• 
  

  chills, pale skin, shakes, cold sweats; or

  
  


• 
  

  anxiety.

  
  

Pentamidine may affect blood sugar levels. Contact your doctor if you experience any high blood sugar symptoms including

• 
  

  increased thirst;

  
  


• 
  

  loss of appetite;

  
  


• 
  

  increase in amount or frequency or urination;

  
  


• 
  

  fruity smelling breath; or

  
  


• 
  

  drowsiness.

  
  

Your doctor may want you to have regular blood, heart function, and blood sugar evaluations during treatment with pentamidine to monitor progress and side effects.

Talk to your doctor if you develop an infection of any kind.

Pentamidine is in the FDA pregnancy category C. This means that it is not known whether pentamidine will harm an unborn baby. Do not take this medication without first talking to your doctor if you are pregnant. It is not known whether pentamidine passes into breast milk. Do not take this medication without first talking to your doctor if you are breast-feeding a baby.

How should I take Nebupent (pentamidine)?

Injectable pentamidine can be administered as an injection into a muscle or by slow infusion. The injection should be administered in a clinical setting where a healthcare provider can monitor blood pressure other vital signs and where an emergency situation can be handled properly.

Your healthcare provider will store injectable pentamidine as directed by the manufacturer.

Pentamidine for inhalation may be administered via the Respigard II nebulizer as part of a home health regimen by a nurse, respiratory therapist or other healthcare practitioner.

Store the prepared solution for inhalation at room temperature, away from light. The solution should be used within 48 hours and any unused portion should be thrown away.

What happens if I miss a dose?

Since the medication will be administered by a healthcare provider, missing a dose should not occur. If you have any questions contact your doctor.

What happens if I overdose?

If an overdose of pentamidine is suspected, seek emergency medical attention or contact your healthcare provider immediately.

Pentamidine should be administered in a clinical setting where a healthcare provider can monitor vital signs (blood pressure, heart rates) and where an emergency situation can be handled immediately.

What should I avoid while taking Nebupent (pentamidine)?

Tell your doctor if you drink alcohol or caffeine drinks regularly, if you are a smoker or if you use illegal drugs. These factors can affect the way pentamidine works in your body.

Nebupent (pentamidine) side effects

Side effects with pentamidine are not common. Serious side effects include:

• 
  

  an allergic reaction (shortness of breath; closing of the throat; hives; swelling of the lips, face, or tongue; rash; or fainting);

  
  


• 
  

  blurred vision;

  
  


• 
  

  chest pain or irregular heart beat;

  
  


• 
  

  difficulty breathing;

  
  


• 
  

  dizziness, confusion, fainting spells or excessive tiredness;

  
  


• 
  

  drastic appetite changes;

  
  


• 
  

  pain or irritation at the injection site;

  
  


• 
  

  mouth ulcers or irritations;

  
  


• 
  

  severe stomach pain;

  
  


• 
  

  bleeding or bruising;

  
  


• 
  

  severe headache;

  
  


• 
  

  chills;

  
  


• 
  

  increased thirst; or

  
  


• 
  

  seizures.

  
  

Other, less serious side effects may be more likely to occur. Talk to your doctor if you experience

• 
  

  taste changes;

  
  


• 
  

  diarrhea; or

  
  


• 
  

  nausea or vomiting.

  
  

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

What other drugs will affect Nebupent (pentamidine)?

Before taking pentamidine, tell your doctor if you are taking any of the following medicines:

• 
  

  azathioprine (Imuran);

  
  


• 
  

  carbamazepine (Tegretol, Epitol, Carbatrol);

  
  


• 
  

  antibiotics;

  
  


• 
  

  anti-inflammatory drugs (ibuprofen (Advil), naproxen (Aleve), others)

  
  


• 
  

  cisplatin (Platinol)

  
  


• 
  

  didanosine (Videx)

  
  


• 
  

  zidovudine (Retrovir)

  
  


• 
  

  birth control pills;

  
  


• 
  

  ganciclovir (Cytovene)

  
  


• 
  

  blood pressure medications;

  
  


• 
  

  medication for diabetes;

  
  


• 
  

  valproic acid (Depakote);

  
  


• 
  

  medication for mental problems; or

  
  


• 
  

  metoclopramide (Reglan).

  
  

You may not be able to take pentamidine, or you may require a dosage adjustment or special monitoring during treatment if you are taking any of the medicines listed above.

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

More Nebupent resources

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

• Nebupent Solution MedFacts Consumer Leaflet (Wolters Kluwer)


• Nebupent Advanced Consumer (Micromedex) - Includes Dosage Information


• Pentamidine MedFacts Consumer Leaflet (Wolters Kluwer)


• NebuPent Prescribing Information (FDA)


• Pentamidine Isethionate Monograph (AHFS DI)

Compare Nebupent with other medications

• Leishmaniasis
• Pneumocystis Pneumonia
• Pneumocystis Pneumonia Prophylaxis
• Trypanosomiasis

Where can I get more information?

• Your pharmacist has additional information about pentamidine written for health professionals that you may read.

See also: Nebupent side effects (in more detail)