Hyosophen

Pronunciation: bell-a-DON-a/fee-noe-BAR-bih-tal
Generic Name: Belladonna Alkaloids/Phenobarbital
Brand Name: Examples include Donnatal and Hyosophen

Hyosophen is used for:

Treating irritable bowel syndrome and intestinal inflammation in combination with other medicines. It may also be used along with other medicines to treat intestinal ulcers. It may also be used for other conditions as determined by your doctor.

Hyosophen is an anticholinergic and barbiturate combination. It works by decreasing the motion of the muscles in the stomach and intestine and providing mild sedation.

Do NOT use Hyosophen if:

• you are allergic to any ingredient in Hyosophen


• you have previously experienced restlessness or excitement after taking phenobarbital


• you have glaucoma; severe irritation of the esophagus or other serious problems with the esophagus (eg, esophageal achalasia); a blockage of the stomach, bowel, or bladder; bowel motility problems; severe bowel inflammation (eg, ulcerative colitis); certain muscle problems (eg, myasthenia gravis); or heart problems with severe bleeding


• you have a history of the blood disorder porphyria


• you have a history of alcohol or substance abuse or dependence or may be at risk for an addiction


• you are taking methoxyflurane, sodium oxybate (GHB), or voriconazole

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

Before using Hyosophen:

Some medical conditions may interact with Hyosophen. 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 nerve problems, prostate problems, heart or blood vessel problems (eg, fast or irregular heartbeat, heart failure, coronary heart disease), hiatal hernia, diarrhea, fever, risk factors for glaucoma, kidney or liver problems, gallbladder problems, lung or breathing problems, an overactive thyroid, high blood pressure, difficulty urinating, or ulcer


• if you have depression, pain, a history of suicidal thoughts or attempts, or are in shock


• if you have been very ill or severely weakened


• if you regularly consume alcohol

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

• Amantadine, antihistamines (eg, diphenhydramine), haloperidol, monoamine oxidase (MAO) inhibitors (eg, phenelzine), phenothiazines (eg, thioridazine), quinine, stiripentol, tricyclic antidepressants (eg, amitriptyline), valproic acid, or other anticholinergics (eg, scopolamine) because they may increase the risk of Hyosophen's side effects


• Methoxyflurane orsodium oxybate (GHB) because the risk of their side effects may be increased by Hyosophen


• Anticoagulants (eg, warfarin), beta-blockers (eg, propranolol), clozapine, corticosteroids (eg, hydrocortisone), cyclosporine, doxorubicin, doxycycline, erlotinib, estrogens (eg, estradiol), imatinib, metronidazole, quinidine, steroidal contraceptives (eg, birth control pills), theophylline, or voriconazole because their effectiveness may be decreased by Hyosophen


• Halothane because Hyosophen may mask the symptoms of halothane toxicity.

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

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

• Take Hyosophen by mouth with or without food.


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

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

Important safety information:

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


• Do not drink alcohol or use medicines that may cause drowsiness (eg, sleep aids, muscle relaxers) while you are using Hyosophen; it may add to their effects. Ask your pharmacist if you have questions about which medicines may cause drowsiness.


• Do not become overheated in hot weather or while you are being active; heatstroke may occur.


• Drink plenty of fluids, maintain good oral hygiene, and suck on sugarless hard candy to relieve dry mouth.


• Hyosophen may make your eyes more sensitive to sunlight. It may help to wear sunglasses.


• Use Hyosophen with caution in the ELDERLY; they may be more sensitive to its effects, especially excitement, agitation, or drowsiness.


• Hyosophen should be used with extreme caution in CHILDREN; safety and effectiveness in children have not been confirmed.


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


• PREGNANCY and BREAST-FEEDING: Hyosophen has been shown to cause harm to the fetus. If you think you may be pregnant, contact your doctor. You will need to discuss the benefits and risks of using Hyosophen while you are pregnant. Hyosophen is found in breast milk. If you are or will be breast-feeding while you use Hyosophen, check with your doctor. Discuss any possible risks to your baby.

When used for long periods of time or at high doses, Hyosophen may not work as well and may require higher doses to obtain the same effect as when originally taken. This is known as TOLERANCE. Talk with your doctor if Hyosophen stops working well. Do not take more than prescribed.

Some people who use Hyosophen for a long time may develop a need to continue taking it. People who take high doses are also at risk. This is known as DEPENDENCE or addiction. If you stop taking Hyosophen suddenly, you may have WITHDRAWAL symptoms. These may include anxiety, nausea, sleeplessness, body aches, seizures, and delirium.

Possible side effects of Hyosophen:

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:

Bloated feeling; blurred vision; clumsiness; constipation; decreased sweating; dizziness; drowsiness; dry mouth; excessive daytime drowsiness ("hangover effect"); feeling of a whirling motion; headache; lightheadedness; nausea; nervousness; tired feeling; trouble sleeping.

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); agitation; confusion; diarrhea; difficulty focusing eyes; disorientation; exaggerated feeling of well-being; excitement; fainting; fast or irregular heartbeat; hallucinations; loss of coordination; loss of taste; memory loss; muscle pain; pounding in the chest; severe or persistent trouble sleeping; trouble urinating; unusual weakness; very slow breathing; vision changes; vomiting.

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

See also: Hyosophen side effects (in more detail)

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately. Symptoms may include change in size of pupil; deep sleep; hot, dry skin; loss of consciousness; severe dry mouth; severe or persistent headache or nausea; slowed or fast breathing; trouble swallowing; vomiting.

Proper storage of Hyosophen:

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

General information:

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


• Hyosophen 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 Hyosophen. 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 Hyosophen resources

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

Generic Name: Influenza Virus Vaccine Live Intranasal
Class: Vaccines
VA Class: IM100

Introduction

Live, attenuated virus vaccine.^{1 100} Seasonal influenza virus vaccine live intranasal is a trivalent vaccine containing live (cold-adapted) influenza virus types A and B and is used to stimulate active immunity to influenza virus strains contained in the vaccine.^{1 100}

Uses for FluMist

Prevention of Seasonal Influenza A and B Virus Infections

Prevention of seasonal influenza virus infection in children ≥2 years of age, adolescents, and adults 18 through 49 years of age.^{1 100 200}

Influenza is an acute viral infection; influenza viruses spread from person to person mainly through large-particle respiratory droplet transmission.¹⁰⁰ In the US, epidemics of seasonal influenza occur annually, usually during late fall through early spring.¹⁰⁰ Influenza viruses can cause illness in any age group; children have highest rate of infection.¹⁰⁰ Influenza can exacerbate underlying medical conditions or lead to pneumonia in certain individuals.¹⁰⁰ Individuals ≥65 years of age, children <2 years of age, and individuals with chronic medical conditions have highest risk of influenza-related complications and death.¹⁰⁰

Annual vaccination is the most effective strategy for preventing seasonal influenza and its complications.¹⁰⁰

Beginning in the 2010–2011 influenza season, the US Public Health Service Advisory Committee on Immunization Practices (ACIP) recommends routine influenza vaccination for all adults, adolescents, and infants and children ≥6 months of age using an age-appropriate seasonal influenza vaccine, unless contraindicated.¹⁰⁰ However, seasonal influenza vaccination efforts should continue to target individuals at higher risk of influenza or influenza-related complications and those who live with or care for such individuals (e.g., health-care personnel, household or other close contacts).¹⁰⁰

For prevention of seasonal influenza infection, 2 different types of influenza vaccine are commercially available in the US: intranasal vaccine containing live, attenuated virus^{1 100} and parenteral (IM) vaccine containing inactivated virus subunits.^{3 5 12 15 17 18 100} Both vaccine types contain influenza virus strains antigenically equivalent to the annually recommended seasonal influenza strains.¹⁰⁰ Possible advantages of the intranasal live vaccine include its potential to induce a broad mucosal and systemic immune response, ease of administration, and improved acceptance of intranasal rather than IM administration;¹⁰⁰ possible disadvantages include restrictions based on age or medical conditions and risk that the live vaccine virus could be transmitted from the vaccinee to close contacts who are severely immunocompromised.¹⁰⁰ (See Transmission of Vaccine Virus under Cautions.)

ACIP, AAP, American Academy of Family Physicians (AAFP), and other experts state that either seasonal intranasal live influenza vaccine or seasonal parenteral inactivated vaccine can be used for prevention of seasonal influenza infection in healthy, nonpregnant individuals 2 through 49 years of age who do not have underlying medical conditions that put them at higher risk for influenza complications.^{100 105 200} This includes health-care personnel, household contacts, and other individuals (e.g., day-care providers) who are in close contact with individuals at high risk of influenza complications or in close contact with certain immunocompromised individuals (e.g., those not requiring a protective environment, those with diabetes or HIV infection, asthma patients taking corticosteroids).^{100 200}

Do not use seasonal intranasal live influenza vaccine in health-care workers, household members, or other individuals who have close contact with severely immunocompromised individuals requiring a protective environment (e.g., hematopoietic stem cell transplant [HSCT] recipients).¹⁰⁰ (See Individuals with Altered Immunocompetence and Their Close Contacts under Cautions.) Use the seasonal parenteral inactivated influenza vaccine in these individuals.¹⁰⁰

Travelers who want to reduce their risk for influenza infection should receive vaccination with seasonal influenza vaccine, preferably at least 2 weeks before departure.^{100 117} The risk for exposure to seasonal influenza during travel depends on the time of year and destination.^{100 117} In the tropics, influenza can occur throughout the year.^{100 117} In temperate regions of the southern hemisphere, influenza activity generally occurs from April through September; in temperate climates, travelers also may be exposed to influenza during the summer (especially when traveling as part of large tourist groups that include individuals from areas of the world where influenza is circulating).^{100 117} ACIP recommends that travelers (especially those at high risk for influenza complications) be vaccinated against seasonal influenza before travel if they were not vaccinated during the preceding fall or winter, will be traveling to the tropics, traveling with organized tourist groups at any time of year, or traveling to the southern hemisphere between April and September.¹⁰⁰

Safety and efficacy of seasonal intranasal live influenza vaccine not established in children <2 years of age or adults ≥50 years of age;¹ use the parenteral inactivated seasonal influenza vaccine in these age groups.¹⁰⁰

Safety of seasonal intranasal live influenza vaccine not established in individuals with underlying medical conditions that may predispose them to severe disease following influenza infection;^{1 100} use the parenteral inactivated seasonal influenza vaccine in these individuals.¹⁰⁰

Seasonal influenza vaccines are not effective against all strains of influenza, but may be effective against those strains (and closely related strains) represented in the vaccines.¹⁰⁰

Seasonal influenza vaccines for the 2010–2011 influenza season are expected to provide protection against infection with the 2009 pandemic influenza A (H1N1) virus, previously referred to as the novel 2009 influenza A (H1N1) virus or swine-origin influenza A (H1N1) virus.¹⁰⁰

Individuals who received the influenza A (H1N1) 2009 monovalent vaccine during the 2009–2010 influenza season should receive the 2010–2011 seasonal influenza vaccine, unless contraindicated. The 2009 pandemic influenza A (H1N1) virus is expected to continue to circulate during the 2010–2011 season and the duration of protection after receipt of the monovalent vaccine is unknown and likely declines over time.¹⁰⁰ In addition, the seasonal vaccine also provides protection against influenza A (H3N2) and influenza B.¹⁰⁰ ACIP states that there is no harm in administering 2010–2011 seasonal influenza vaccine to an individual who was previously infected with the 2009 pandemic influenza A (H1N1) virus.¹⁰⁰

Seasonal influenza vaccines are not expected to provide protection against infection with avian influenza A viruses, including avian influenza A (H5N1).¹⁰⁰

Information regarding influenza surveillance and updated recommendations for prevention and treatment of seasonal influenza is available from CDC at .

FluMist Dosage and Administration

Administration

Intranasal Administration

Administer intranasally using the prefilled, single-use sprayer supplied by the manufacturer.¹

Do not administer IM, IV, or intradermally.¹⁰⁰

Intranasal live influenza vaccine is a colorless to pale yellow liquid and may be clear to slightly cloudy.¹ Do not mix with any other vaccine or solution.¹¹⁸

Administer every year before exposure to seasonal influenza.^{1 100} Optimum time for annual vaccination against seasonal influenza cannot be determined since influenza seasons vary in timing and duration and more than one outbreak might occur in a single community during a single year.¹⁰⁰ In the US, localized outbreaks indicating start of the annual influenza season can occur as early as October; peak influenza activity often occurs in January or February, but has occurred as late as April or May.¹⁰⁰ Begin vaccination efforts each year by October or as soon as the seasonal influenza vaccine is available; continue vaccination efforts throughout influenza season, even after influenza activity has begun in the community.¹⁰⁰

Intranasal live influenza vaccine must be administered by a health-care provider.¹ Severely immunosuppressed individuals should not administer the vaccine.¹⁰⁰ (See Administration Precautions under Cautions.) Other individuals at high risk of influenza complications (e.g., those with underlying medical conditions, pregnant women, individuals with asthma, individuals >50 years of age) may administer the vaccine.¹⁰⁰

Place recipient in an upright position.¹ Administer approximately one-half the contents of the prefilled, single-use sprayer into each nostril.¹ Consult manufacturer’s labeling for specific information regarding use of the sprayer.¹

After administering vaccine, carefully dispose of the sprayer (i.e., discard using standard procedures for medical waste).^{1 119}

If vaccine recipient sneezes after receiving a dose, do not repeat the dose.¹⁰⁰

If nasal congestion might impede delivery of vaccine to nasopharyngeal mucosa, defer administration until symptoms subside.¹⁰⁰ Alternatively, use the parenteral inactivated seasonal influenza vaccine.¹⁰⁰

May be given simultaneously with other age-appropriate vaccines during same health-care visit.^{100 105 118 200} (See Interactions.)

Dosage

Dosing schedule for prevention of seasonal influenza depends on individual’s age and vaccination status.^{1 100 105}

A single-dose regimen of seasonal influenza vaccine is used in children ≥9 years of age, adolescents, and adults 18 through 49 years of age.^{1 100 105 200}

ACIP and AAP state that a single-dose regimen of 2010–2011 seasonal influenza vaccine can be used in children 2 through 8 years of age who received 2 doses of any type of seasonal influenza vaccine during the 2009–2010 influenza season and received at least 1 dose of any type of influenza A (H1N1) 2009 monovalent vaccine during the 2009–2010 season.^{100 105} A single-dose regimen also can be used in children 2 through 8 years of age who were vaccinated against seasonal influenza prior to the 2009–2010 influenza season and received at least 1 dose of any type of influenza A (H1N1) 2009 monovalent vaccine during the 2009–2010 season.^{100 105}

However, ACIP and AAP state that a 2-dose regimen of 2010–2011 seasonal influenza vaccine should be used in children 2 through 8 years of age who did not receive any doses of influenza A (H1N1) 2009 monovalent vaccine during the 2009–2010 influenza season or have an uncertain history regarding vaccination with the influenza A (H1N1) 2009 monovalent vaccine.^{100 105}

A 2-dose regimen of 2010–2011 seasonal influenza vaccine also is necessary in children 2 through 8 years of age who have not previously received any type of seasonal influenza vaccine,^{100 105} received seasonal influenza vaccine for the first time during the 2009–2010 season but received only a single dose,^{100 105} or have an uncertain history regarding vaccination with seasonal influenza vaccine.^{100 105}

ACIP states that there is no harm in administering 2 doses of 2010–2011 seasonal influenza vaccine to a child who was previously infected with the 2009 pandemic influenza A (H1N1) virus.¹⁰⁰ However, at the clinician's discretion, children with a history of laboratory-confirmed 2009 pandemic H1N1 virus infection (i.e., confirmed with reverse transcription polymerase chain reaction [PCR] testing or virus culture specific for 2009 pandemic influenza A [H1N1] virus) can be considered to have been vaccinated against this virus when determining whether a single- or 2-dose regimen of seasonal influenza vaccine is needed.¹⁰⁰ Children 2 through 8 years of age who had a febrile respiratory illness during 2009–2010 and did not receive specific diagnostic testing for the 2009 pandemic influenza A (H1N1) virus (i.e., were not tested or were tested with a rapid antigen test) cannot be assumed to have had influenza A (H1N1) virus infection and, therefore, should receive 2 doses of 2010–2011 seasonal influenza vaccine.¹⁰⁰

A single dose consists of the entire contents of the sprayer (0.2 mL).¹

Pediatric Patients

Prevention of Seasonal Influenza A and B Virus Infections

Children 2 through 8 Years of Age

Intranasal

Received 2 doses of any type of seasonal influenza vaccine during the 2009–2010 influenza season and received at least 1 dose of any type of influenza A (H1N1) 2009 monovalent vaccine during the 2009–2010 season^{100 105} : Single dose consisting of 0.2 mL (0.1 mL in each nostril).^{1 100 105}

Received any type of seasonal influenza vaccine prior to the 2009–2010 influenza season and received at least 1 dose of any type of influenza A (H1N1) 2009 monovalent vaccine during the 2009–2010 season^{100 105} : Single dose consisting of 0.2 mL (0.1 mL in each nostril).^{1 100 105}

Did not previously receive any type of seasonal influenza vaccine or received seasonal influenza vaccine for the first time during the 2009–2010 season and received only a single dose: 2 doses administered at least 1 month apart.^{100 105} Each dose consists of 0.2 mL (0.1 mL in each nostril).^{1 100 105}

Did not receive any doses of influenza A (H1N1) 2009 monovalent vaccine during the 2009–2010 influenza season: 2 doses administered at least 1 month apart.^{100 105} Each dose consists of 0.2 mL (0.1 mL in each nostril).^{1 100 105}

Uncertain history of previous vaccination with any type of seasonal influenza vaccine and/or uncertain history regarding vaccination with influenza A (H1N1) 2009 monovalent vaccine during the 2009–2010 season: 2 doses administered at least 1 month apart.^{100 105} Each dose consists of 0.2 mL (0.1 mL in each nostril).^{1 100 105}

Children and Adolescents 9 through 17 Years of Age

Intranasal

Single dose consisting of 0.2 mL (0.1 mL in each nostril).^{1 100 105}

Adults

Prevention of Seasonal Influenza A and B Virus Infections

Adults 18 through 49 Years of Age

Intranasal

Single dose consisting of 0.2 mL (0.1 mL in each nostril).^{1 100}

Special Populations

Hepatic Impairment

No specific dosage recommendations.¹

Renal Impairment

No specific dosage recommendations.¹

Geriatric Patients

Not indicated in adults ≥50 years of age, including geriatric adults.¹

Cautions for FluMist

Contraindications

• 
  

  History of hypersensitivity (especially anaphylactic reactions) to egg or egg proteins, gentamicin, gelatin, or arginine.¹

  
  


• 
  

  Life-threatening reaction to previous dose of influenza vaccine.¹

  
  


• 
  

  Children and adolescents 2–17 years of age receiving aspirin or aspirin-containing therapy because of association of Reye's syndrome with aspirin use and wild-type influenza infection.¹

  
  

Warnings/Precautions

Sensitivity Reactions

Hypersensitivity Reactions

Hypersensitivity reactions (e.g., anaphylactic reaction, facial edema, urticaria) reported.¹

Seasonal intranasal live influenza vaccine is produced using eggs,^{1 100 105 118} and can contain residual egg protein that may induce immediate hypersensitivity reactions, including anaphylaxis, in individuals with severe egg allergy.^{100 118} The manufacturer, ACIP, and AAP state that influenza vaccines should not be used in individuals with a history of anaphylactic or other immediate hypersensitivity reaction (e.g., hives, angioedema, allergic asthma) to eggs or egg proteins.^{1 100 105 118} (See Contraindications under Cautions.) AAP states that less severe or local manifestations of allergy to eggs or feathers are not contraindications to routine administration of influenza vaccine.¹⁰⁵ ACIP states that asking patients if they can eat eggs without adverse effects is a reasonable way to identify those who may be at risk for allergic reactions if they receive the vaccine.^{100 118} Those who can eat eggs or egg products safely usually can receive influenza vaccine; those with a history of anaphylactic or other immediate hypersensitivity reaction (e.g., hives, angioedema, allergic asthma) to eggs or egg proteins should not receive the vaccine.¹¹⁸

Appropriate medical treatment and supervision must be readily available in case anaphylaxis occurs.¹

Do not administer additional vaccine doses to any individual who had a life-threatening reaction to a previous dose.¹ (See Contraindications under Cautions.)

Infants <24 Months of Age

Do not use in infants <24 months of age; increased risk of wheezing and hospitalization reported in clinical trials in this age group.¹ (See Pediatric Use under Cautions.)

Individuals with Asthma or Recurrent Wheezing

Do not use in individuals with asthma or in children <5 years of age with history of recurrent wheezing or a recent wheezing episode (i.e., during the past 12 months)^{1 100 105} unless potential benefits outweigh risks;¹ increased risk of wheezing in such individuals.¹ (See Pediatric Use under Cautions.)

Do not use under any circumstances in individuals with severe asthma or active wheezing; not evaluated to date in such individuals.¹

Guillain-Barré Syndrome

Carefully consider possible benefits and potential risks of intranasal live influenza vaccine in individuals who experienced Guillain-Barré syndrome (GBS) within 6 weeks of previous influenza vaccination.¹

Unclear whether influenza vaccination increases risk of recurrence of GBS.^{100 105} AAP states that influenza vaccines should not be used in children who developed GBS within 6 weeks after a previous dose of any influenza vaccine.¹⁰⁵ ACIP states that, as a precaution, individuals who are not at high risk for severe influenza complications and who developed GBS within 6 weeks of a previous dose of influenza vaccine generally should avoid influenza vaccination.¹⁰⁰ Although data are limited, ACIP states that use of influenza vaccine can be considered in individuals with a history of GBS who are at high risk for severe complications from influenza.¹⁰⁰

Individuals with Altered Immunocompetence and Their Close Contacts

Only limited data available regarding safety and efficacy in immunocompromised individuals.¹ Carefully consider possible benefits and potential risks in such individuals.¹

ACIP states that live viral vaccines (including intranasal live influenza vaccine) usually should not be used in immunocompromised individuals, except in certain circumstances.¹¹⁸ These experts state that use of live virus vaccines can be considered in patients with leukemia, lymphoma, or other malignancies if the disease is in remission and chemotherapy was terminated at least 3 months prior to vaccination.¹¹⁸ (See Specific Drugs under Interactions.)

Has been used in a limited number of HIV-infected adults (asymptomatic or mildly symptomatic) in a clinical study;¹ no serious adverse effects reported, but efficacy not evaluated.¹ CDC, NIH, IDSA, AAP, and other experts state that HIV-infected children, adolescents, and adults should receive annual vaccination against seasonal influenza; however, the parenteral inactivated influenza vaccine (not the intranasal live vaccine) should be used for prevention of seasonal influenza in HIV-infected individuals.^{105 155 156}

Because of possible transmission of live vaccine viruses, intranasal live influenza vaccine should not be administered to close contacts of severely immunocompromised individuals requiring a protective environment (e.g., HSCT recipients); however, ACIP states that the vaccine may be administered to close contacts of less severely immunocompromised individuals (e.g., those not requiring a protective environment).¹⁰⁰

In addition, because of possible transmission of live vaccine viruses, ACIP states that health-care workers who have received the intranasal vaccine should avoid contact with severely immunocompromised patients requiring a protective environment (e.g., HSCT recipients) for 7 days after vaccination.¹⁰⁰ Hospital visitors who have received the vaccine should avoid contact with severely immunosuppressed patients for 7 days after vaccination but may visit patients who are not severely immunosuppressed.¹⁰⁰

Individuals with Medical Conditions that Increase Risk of Influenza Complications

Safety not established in individuals with underlying medical conditions that increase risk for complications following wild-type influenza infection.^{1 100 105}

Individuals at increased risk of influenza complications include those with chronic pulmonary (including asthma), cardiovascular (except hypertension), renal, hepatic, neurologic, hematologic, or metabolic (including diabetes mellitus) disorders and those who are immunosuppressed (including immunosuppression caused by drug therapy or HIV infection).¹⁰⁰ (See Individuals with Altered Immunocompetence and Their Close Contacts under Cautions.) Do not use in these individuals unless possible benefits outweigh risks.¹

Transmission of Vaccine Virus

Intranasal influenza vaccine contains live, attenuated virus.^{1 100} Vaccine virus capable of infection and replication is present in nasal secretions of vaccine recipients¹ and viral shedding occurs in adults and children who have received the intranasal live vaccine.^{1 100}

Relationship between vaccine virus replication in vaccine recipients and transmission of vaccine virus to other individuals not established.¹ Transmission of vaccine virus has occurred rarely between recipients of intranasal influenza vaccine and their contacts.^{1 100}

Duration of vaccine virus replication and shedding in vaccine recipients not established.¹

Limitations of Vaccine Effectiveness

May require up to 2 weeks for protection to develop following seasonal influenza vaccination.¹⁰⁰

May not protect all vaccine recipients against influenza.¹

Seasonal influenza vaccine is formulated annually to contain influenza A and B antigens predicted to represent strains of influenza virus likely to circulate in the US during the upcoming influenza season.^{1 100} (See Actions.) Efficacy of the seasonal vaccine during any given year depends on how closely viral strains represented in the vaccine match viral strains circulating during the season.¹⁰⁰

Intranasal influenza vaccine for the 2010–2011 influenza season is expected to provide protection against the 2009 pandemic influenza A (H1N1) virus, previously referred to as the novel 2009 influenza A (H1N1) virus or swine-origin influenza A (H1N1) virus,¹⁰⁰ but is not expected to provide protection against infection with avian influenza A viruses, including avian influenza A (H5N1).¹⁰⁰

Duration of Immunity

Immunity declines during the year after seasonal influenza vaccination.¹ In addition, circulating strains of seasonal influenza virus change from year to year.^{1 23 100} Annual vaccination is needed for prevention of seasonal influenza.^{1 100}

Do not administer influenza vaccine from a previous influenza season in an attempt to provide protection during a subsequent influenza season.¹⁰⁰

Concomitant Illness

ACIP states that minor acute illness, such as mild diarrhea or mild upper respiratory tract infection (with or without fever), generally does not preclude vaccination.^{100 118} If nasal congestion will impede delivery of the vaccine to the nasopharyngeal mucosa, defer administration until illness resolves.¹⁰⁰

Administration Precautions

Health-care personnel who are severely immunosuppressed should not administer intranasal live influenza vaccine to patients.¹⁰⁰ Small amounts of vaccine virus are likely to be introduced into the environment; the risk of acquiring vaccine virus from the environment is unknown, but presumed to be low.¹⁰⁰

Improper Storage and Handling

Improper storage or handling of vaccines may result in loss of vaccine potency and reduced immune response in vaccinees.¹¹⁸

Inspect all vaccines upon delivery and monitor during storage to ensure that the appropriate temperature is maintained.^{118 119}

Do not administer vaccine that has been mishandled or has not been stored at the recommended temperature.^{1 118} (See Storage under Stability.) If there are concerns about mishandling, contact the manufacturer or state or local health departments for guidance on whether the vaccine is usable.^{118 119}

Specific Populations

Pregnancy

Category C.¹

Manufacturer states that the vaccine should be used in pregnant women only when clearly needed.¹

ACIP, American College of Obstetricians and Gynecologists (ACOG), American College of Physicians (ACP), NIH, IDSA, and other experts state that parenteral inactivated influenza vaccine (not intranasal live influenza vaccine) should be used for prevention of seasonal influenza in pregnant women.^{100 118 155 200}

Lactation

Not known whether influenza virus live is distributed into milk.¹ Manufacturer recommends caution.¹

ACIP states that either seasonal intranasal live influenza vaccine or seasonal parenteral inactivated influenza vaccine can be used for prevention of seasonal influenza in nursing women, unless contraindicated.¹⁰⁰

Pediatric Use

Safety and efficacy established only in children ≥2 years of age.¹

Not indicated in infants <24 months of age.¹ Increased incidence of wheezing and hospitalization reported in a clinical trial in infants 6–23 months of age† who received intranasal live influenza vaccine compared with those who received parenteral inactivated seasonal influenza vaccine.¹

Do not use in children with asthma or in children 2 through 4 years of age with a history of recurrent wheezing or a recent wheezing episode (i.e., during the past 12 months).^{1 100 105}

When considering use in children 2 through 4 years of age, ACIP and AAP recommend that clinicians screen for possible reactive airways diseases by consulting the child's medical record and asking the child's parent or guardian if wheezing or asthma episodes were identified by a health-care provider within the past 12 months.^{100 105} Use seasonal parenteral inactivated influenza vaccine (not intranasal live influenza vaccine) for prevention of seasonal influenza in such children.^{100 105}

Protection of young infants against seasonal influenza virus depends on immunization of their close contacts.^{100 105} All household contacts, health-care and day-care providers, and other close contacts of young infants should receive seasonal influenza vaccination appropriate for their age and target group.^{100 105}

Adults 50–64 Years of Age

Not indicated for use in adults 50–64 years of age.¹ Efficacy not demonstrated in adults 50–64 years of age.¹ Use seasonal parenteral inactivated influenza vaccine (not intranasal live influenza vaccine) for prevention of seasonal influenza in this age group.¹⁰⁰

Geriatric Use

Not indicated for use in geriatric individuals ≥65 years of age.¹ Use seasonal parenteral inactivated influenza vaccine (not intranasal live influenza vaccine) for prevention of seasonal influenza in geriatric adults.¹⁰⁰

Common Adverse Effects

Children 2–6 years of age: Runny nose/nasal congestion, decreased appetite, irritability, lethargy, sore throat, fever, headache, muscle aches, chills.¹

Older children and adolescents up to 17 years of age: Adverse effects similar to those reported in younger children; in addition, abdominal pain and decreased activity.¹

Adults 18–49 years of age: Runny nose, headache, sore throat, tiredness/weakness, muscle aches, cough, chills, nasal congestion, sinusitis.¹

Interactions for FluMist

Inactivated Vaccines and Toxoids

Safety and immunogenicity of intranasal live influenza vaccine administered concomitantly with age-appropriate inactivated vaccines not determined.¹ Manufacturer states risks versus benefits of concomitant administration of the intranasal live influenza vaccine and inactivated vaccines should be considered.¹

ACIP states that, in the absence of specific data indicating interference, inactivated vaccines or toxoids can be administered simultaneously with or at any interval before or after seasonal intranasal live influenza vaccine.¹⁰⁰

Live Vaccines

Intranasal influenza vaccine is a live, attenuated virus vaccine.^{1 100 105 118} ACIP states that influenza virus vaccine live intranasal and other live vaccines generally may be administered simultaneously on the same day.^{100 118}

ACIP states that some oral live vaccines (e.g., typhoid vaccine live oral) can be administered concomitantly with or at any interval before or after intranasal live influenza vaccine.¹¹⁸ However, because of theoretical concerns that the immune response to other live virus vaccines might be impaired if given within 30 days of another live virus vaccine, ACIP states that if intranasal live influenza vaccine and other live vaccines are not administered on the same day, they should be administered at least 4 weeks apart.^{100 118} (See Specific Drugs under Interactions.)

Specific Drugs

Drug	Interaction	Comments
Antiviral agents active against influenza (amantadine, rimantadine, oseltamivir, zanamivir)	Concomitant use of intranasal live influenza vaccine and antivirals used for treatment or prevention of influenza not studied; these antivirals potentially could decrease response to the live vaccine1 100	Do not administer intranasal live influenza vaccine until at least 48 hours after influenza antiviral agent discontinued; do not administer influenza antiviral agent until at least 2 weeks after the vaccine, unless medically necessary1 100 If influenza antiviral agent and intranasal live influenza vaccine are administered concomitantly, consider revaccination if appropriate;1 ACIP recommends revaccination if an influenza antiviral was given 2 days before to 14 days after intranasal live influenza vaccine100
Aspirin	Association of Reye's syndrome with aspirin and wild-type influenza infection 1 100	Contraindicated in children and adolescents receiving aspirin or aspirin-containing therapy1 100
Blood products		Intranasal live influenza vaccine may be administered simultaneously with or at any time before or after whole blood, packed red blood cells, plasma, and platelet products without substantially decreasing antibody response to the vaccine118
Immune globulin (immune globulin IM [IGIM], immune globulin IV [IGIV]) or specific immune globulin (hepatitis B immune globulin [HBIG], rabies immune globulin [RIG], tetanus immune globulin [TIG], varicella zoster immune globulin [VZIG])	No evidence that immune globulin preparations interfere with immune response to intranasal live influenza vaccine118	Intranasal live influenza vaccine may be given simultaneously with or at any interval before or after immune globulin preparations118
Immunosuppressive agents (e.g., alkylating agents, antimetabolites, corticosteroids, radiation)	Potential for decreased antibody response to intranasal live influenza vaccine and increased risk of adverse reactions118	Intranasal live influenza vaccine should not be used in those receiving immunosuppressive therapy105 118 Optimum interval between discontinuance of immunosuppressive therapy and subsequent administration of a live viral vaccine has not been determined118 Live viral vaccines generally should not be administered for at least 3 months after immunosuppressive therapy is discontinued, including chemotherapy or radiation for leukemia, other hematopoietic malignancies, or solid tumors, or after solid organ transplant 118 Systemic corticosteroid therapy (prednisone or equivalent) in a dosage ≥2 mg/kg daily or ≥20 mg daily given for ≥2 weeks is considered immunosuppressive;118 delay administration of live vaccines for at least 1 month after such therapy is discontinued118 Corticosteroid therapy involving short-term (<2 weeks), low- to moderate-dose systemic therapy (<20 mg prednisone or equivalent daily); long-term, alternate-day systemic therapy using short-acting drugs; maintenance physiologic doses (replacement therapy); topical therapy (e.g., cutaneous, ophthalmic); inhalation; or intra-articular, bursal, or tendon injections should not be immunosuppressive and does not usually contraindicate use of live vaccines118
Intranasal preparations (e.g., corticosteroids)	Concomitant administration not evaluated1
Measles, mumps, and rubella vaccine (MMR)	Simultaneous administration of intranasal live influenza vaccine with MMR and monovalent varicella vaccine in infants 12–15 months of age did not interfere with the immune response to any of the antigens and did not increase frequency of adverse effects;1 25 100 safety and immunogenicity of simultaneous administration not evaluated in infants >15 months of age1	If not given simultaneously, give at least 4 weeks apart whenever possible100 118
Rotavirus vaccine (RV)	Concomitant use not studied;26 rotavirus vaccine not indicated in children ≥2 years of age (the age group that can receive intranasal live influenza vaccine)26
Varicella vaccine (VAR)	Simultaneous administration of intranasal live influenza vaccine with monovalent varicella vaccine and MMR vaccine in infants 12–15 months of age did not interfere with the immune response to any of the antigens and did not increase frequency of adverse effects;1 25 100 safety and immunogenicity of concomitant administration not evaluated in infants >15 months of age1	If not given simultaneously, give at least 4 weeks apart whenever possible100 118

Stability

Storage

Intranasal Spray

Suspension

2–8°C; do not freeze.¹

Does not contain thimerosal or any other preservatives.¹

ActionsActions

• 
  

  Influenza virus vaccine live intranasal that is used for prevention of seasonal influenza is a trivalent vaccine containing live, attenuated (cold-adapted) influenza virus types A and B.^{1 100}

  
  


• 
  

  Seasonal influenza vaccines are formulated annually to contain antigens representative of the influenza A (H1N1), influenza A (H3N2), and influenza B viruses likely to circulate in the US during the upcoming influenza season.^{1 100 104}

  
  


• 
  

  Seasonal intranasal live influenza vaccine is considered antigenically equivalent to seasonal parenteral inactivated influenza vaccine.¹⁰⁰

  
  


• 
  

  The 2010–2011 seasonal intranasal live influenza vaccine for the US contains A/California/7/2009 (H1N1), A/Perth/16/2009 (H3N2), and B/Brisbane/60/2008.^{1 100 104} The A/California/7/2009 (H1N1) antigen is derived from the pandemic 2009 influenza A (H1N1) virus and is the same antigen used in the previously available intranasal live influenza A (H1N1) 2009 monovalent vaccine.¹⁰⁰

  
  


• 
  

  Only 1 of 3 antigens contained in the 2010–2011 seasonal influenza vaccine (the influenza type B component) is the same as that contained in the seasonal influenza vaccine used during the previous influenza season (2009–2010).^{100 104}

  
  


• 
  

  Influenza vaccines stimulate active immunity to influenza virus strains represented in the vaccines.^{1 100}

  
  


• 
  

  Following administration of intranasal live influenza vaccine, vaccine virus replicates in cells lining the nasopharynx.^{1 100} Protective mechanism not completely understood; may involve both serum and mucosal antibodies.^{1 100}

  
  


• 
  

  Efficacy of seasonal influenza vaccine in preventing seasonal influenza virus infection depends on whether the virus strains represented in the vaccine are antigenically similar to influenza virus strains circulating during the influenza season.¹⁰⁰

  
  


• 
  

  Seasonal influenza vaccines for the 2010–2011 influenza season are expected to provide protection against the 2009 pandemic influenza A (H1N1) virus, previously referred to as the novel 2009 influenza A (H1N1) or swine-origin influenza A (H1N1) virus.¹⁰⁰

  
  

Advice to Patients

• 
  

  Prior to administration of seasonal influenza virus vaccine live, provide a copy of the appropriate CDC Vaccine Information Statement (VIS) to the patient or patient's legal representative (VISs are available at ).²⁰

  
  


• 
  

  Advise patient and/or patient's parent or guardian of the risks and benefits of vaccine administration.¹

  
  


• 
  

  Importance of annual vaccination against seasonal influenza.^{1 100}

  
  


• 
  

  Advise patient and/or patient's parent or guardian that a single dose of seasonal influenza vaccine is necessary each year in adults, adolescents, and children ≥9 years of a

Visonex

Generic Name: guaifenesin and phenylephrine (gwye FEN e sin and FEN il EFF rin)

Brand Names: Aldex G, Aquatab D, Crantex, D-Phen 1000, D-Tab, Deconex, Deconsal II, Deconsal Pediatric, Despec, Donatussin Drops, Duomax, Duraphen 1000, Duraphen II, Duratuss, Dynex LA, ExeTuss, Extendryl G, Fenesin PE IR, Genexa LA, Gentex LA, Gilphex TR, Guaiphen-D 1200, Guaiphen-D 600, Guaiphen-PD, Guiadex PD, Guiatex PE, J-Max, Liquibid D-R, Liquibid-D, Liquibid-PD, Lusonex, Maxiphen, Medent-PE, MontePhen, Mucinex Children's Cold, Mucus Relief Sinus, Mydex, Nariz, Nasex, Nescon-PD, Nexphen PD, Norel EX, PE-Guai, Pendex, Prolex D, Refenesen PE, Reluri, Rescon-GG, Respa-PE, Robitussin Head & Chest Congestion, Simuc, Simuc-GP, Sina-12X, Sinupan, SINUvent PE, Sitrex PD, Sudafed PE Non-Drying Sinus, Sudex, Triaminic Chest & Nasal Congestion, Visonex, Wellbid-D, Xedec, Xedec II, Xpect-PE, Zotex GPX

What is Visonex (guaifenesin and phenylephrine)?

There are many brands and forms of guaifenesin and phenylephrine available and not all brands are listed on this leaflet.

Guaifenesin is an expectorant. It helps loosen congestion in your chest and throat, making it easier to cough out through your mouth.

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

The combination of guaifenesin and phenylephrine is used to treat stuffy nose and sinus congestion, and to reduce chest congestion caused by the common cold or flu.

Guaifenesin and phenylephrine may also be used for purposes not listed in this medication guide.

What is the most important information I should know about Visonex (guaifenesin and phenylephrine)?

There are many brands and forms of guaifenesin and phenylephrine available and not all brands are listed on this leaflet.

Do not give this medication to a child younger than 4 years old. Always ask a doctor before giving a cough or cold medicine to a child. Death can occur from the misuse of cough and cold medicines in very young children. Ask a doctor or pharmacist before using any other cough, cold, or allergy medicine. Guaifenesin and phenylephrine are contained in many combination medicines. Taking certain products together can cause you to get too much of a certain drug. Check the label to see if a medicine contains guaifenesin or phenylephrine.

What should I discuss with my healthcare provider before taking Visonex (guaifenesin and phenylephrine)?

You should not use this medication if you are allergic to guaifenesin or phenylephrine, or to other decongestants, diet pills, stimulants, or ADHD medications. Do not use guaifenesin and phenylephrine if you have used an MAO inhibitor such as furazolidone (Furoxone), isocarboxazid (Marplan), phenelzine (Nardil), rasagiline (Azilect), selegiline (Eldepryl, Emsam, Zelapar), or tranylcypromine (Parnate) in the last 14 days. Serious, life threatening side effects can occur if you use guaifenesin and phenylephrine before the MAO inhibitor has cleared from your body.

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

• 
  

  heart disease or high blood pressure;

  
  


• 
  

  diabetes;

  
  


• 
  

  circulation problems;

  
  


• 
  

  glaucoma;

  
  


• 
  

  overactive thyroid; or

  
  


• 
  

  enlarged prostate or problems with urination.

  
  

It is not known if this medication may be harmful to an unborn baby. Do not use this medication without your doctor's advice if you are pregnant. This medication passes into breast milk and could harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby.

Artificially-sweetened liquid forms of cold medicine may contain phenylalanine. This would be important to know if you have phenylketonuria (PKU). Check the ingredients and warnings on the medication label if you are concerned about phenylalanine.

How should I take Visonex (guaifenesin and phenylephrine)?

Use exactly as directed on the label, or as prescribed by your doctor. Do not use in larger or smaller amounts or for longer than recommended. Cold medicine is usually taken only for a short time until your symptoms clear up.

Do not give this medication to a child younger than 4 years old. Always ask a doctor before giving cough or cold medicine to a child. Death can occur from the misuse of cough or cold medicine in very young children.

Measure the liquid form of this 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.

Do not crush, chew, break, or open an extended-release tablet or capsule. Swallow it whole. Breaking or opening the pill may cause too much of the drug to be released at one time. Take guaifenesin and phenylephrine with food if it upsets your stomach. Talk with your doctor if your symptoms do not improve after 7 days of treatment, or if you have a fever with a headache, cough, or skin rash. Drink extra fluids to help loosen the congestion and lubricate your throat while you are taking this medication. Store at room temperature away from moisture and heat.

What happens if I miss a dose?

Since cough or cold medicine is taken as needed, you may not be on a dosing schedule. If you are taking the medication regularly, take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Overdose symptoms may include nausea, vomiting, numbness or tingly feeling, dizziness, and feeling restless or nervous.

What should I avoid while taking Visonex (guaifenesin and phenylephrine)?

This medication may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be alert. Drinking alcohol can increase certain side effects of guaifenesin and phenylephrine. Ask a doctor or pharmacist before using any other cough, cold, or allergy medicine. Guaifenesin and phenylephrine are contained in many combination medicines. Taking certain products together can cause you to get too much of a certain drug. Check the label to see if a medicine contains guaifenesin or phenylephrine.

Avoid taking this medication with diet pills, caffeine pills, or other stimulants (such as ADHD medications) without your doctor's advice. Taking a stimulant together with a decongestant can increase your risk of unpleasant side effects.

Visonex (guaifenesin and phenylephrine) 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 using this medication and call your doctor at once if you have any of these serious side effects:

• 
  

  fast, pounding, or uneven heartbeat;

  
  


• 
  

  severe dizziness, anxiety, restless feeling, or nervousness;

  
  


• 
  

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

  
  


• 
  

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

  
  


• 
  

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

  
  

Less serious side effects may include:

• 
  

  vomiting, upset stomach;

  
  


• 
  

  warmth, tingling, or redness under your skin;

  
  


• 
  

  feeling excited or restless (especially in children);

  
  


• 
  

  sleep problems (insomnia);

  
  


• 
  

  skin rash or itching;

  
  


• 
  

  headache; or

  
  


• 
  

  dizziness.

  
  

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What other drugs will affect Visonex (guaifenesin and phenylephrine)?

Ask a doctor or pharmacist if it is safe for you to take guaifenesin and phenylephrine if you are also using any of the following drugs:

• 
  

  medicines to treat high blood pressure;

  
  


• 
  

  a beta-blocker such as atenolol (Tenormin, Tenoretic), carvedilol (Coreg), labetalol (Normodyne, Trandate), metoprolol (Dutoprol, Lopressor, Toprol), nadolol (Corgard), propranolol (Inderal, InnoPran), sotalol (Betapace), and others; or

  
  


• 
  

  an antidepressant such as amitriptyline (Elavil, Vanatrip, Limbitrol), doxepin (Sinequan, Silenor), desipramine (Norpramin), imipramine (Janimine, Tofranil), nortriptyline (Pamelor), and others.

  
  

This list is not complete and other drugs may interact with guaifenesin and phenylephrine. Tell your doctor about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal products. Do not start a new medication without telling your doctor.

More Visonex resources

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

• Crantex Prescribing Information (FDA)


• Despec Drops MedFacts Consumer Leaflet (Wolters Kluwer)


• Entex LA Sustained-Release Capsules MedFacts Consumer Leaflet (Wolters Kluwer)


• Gentex LA Sustained-Release Tablets (12 Hour) MedFacts Consumer Leaflet (Wolters Kluwer)


• Guiatex PE Prescribing Information (FDA)


• Lusonex Controlled-Release Tablets MedFacts Consumer Leaflet (Wolters Kluwer)


• Rescon-GG Liquid MedFacts Consumer Leaflet (Wolters Kluwer)


• Sina-12X Suspension MedFacts Consumer Leaflet (Wolters Kluwer)

Compare Visonex with other medications

• Cough and Nasal Congestion
• Sinus Symptoms

Where can I get more information?

• Your pharmacist can provide more information about guaifenesin and phenylephrine.

See also: Visonex side effects (in more detail)

Striant

Generic Name: testosterone (Buccal route)

tes-TOS-ter-one

Commonly used brand name(s)

In the U.S.

• Striant

Available Dosage Forms:

• Patch, Extended Release

Therapeutic Class: Endocrine-Metabolic Agent

Pharmacologic Class: Androgen

Uses For Striant

Testosterone are male hormones. Some are naturally produced in the body and are responsible for the growth and development of male sex organs

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

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

• Female-to-male transsexualism in patients with gender identity disorder, (person who is born as a woman but adapts to a man's lifestyle, sees herself as a man, and feels like a man instead of a woman)

Before Using Striant

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 on adult patients, and there is no specific information comparing use of testosterone 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. However older men may be at increased risk for development of prostatic hyperplasia and prostatic cancer.

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.

• Anisindione


• Bupropion


• Dicumarol


• Paclitaxel


• Paclitaxel Protein-Bound


• Phenprocoumon


• Warfarin

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

• Licorice

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:

• Breast cancer (in males) or


• Prostate cancer—Androgens can cause growth of these tumors.

• Diabetes mellitus (sugar diabetes)—Testosterone may decrease blood sugar levels. Careful monitoring of blood glucose should be done.

• Heart disease or


• Kidney disease or


• Liver disease—These conditions can be worsened by the fluid retention (keeping too much water in the body) that can be caused by androgens. Also, liver disease can prevent the body from removing the medicine from the bloodstream as fast as it normally would. This could increase the chance of side effects occurring.

• Sleep apnea—This condition may become worse, especially in patients with risk factors such as obesity or chronic lung disease.

Proper Use of Striant

Importance of reading the patient directions carefully before using the buccal system

Proper administration technique

Proper dosing. Use this medicine only as directed.

Proper storage

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 buccal dosage form:
  
  • For testosterone hormone replacement in men
    
    • Adults—30 milligrams (mg) applied to your upper gum above the left or right incisor twice a day
    
    
  
  

Missed Dose

Call your doctor or pharmacist for instructions.

If the buccal system fails to properly adhere to the gum or should fall off during the 12-hour dosing interval, the old one should be removed and a new buccal system applied. If the old one falls out within 4 hours before the next dose, a new system should be applied and it may remain in place until the time of the next regularly scheduled dosing. 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 Striant

If you will be taking this medicine for a long time, it is very important that your doctor check you at regular visits to check your progress during therapy.

For patients with diabetes mellitus (sugar diabetes), this medicine may lower blood sugar levels. If you notice a change in the results of your blood or urine sugar tests or if you have any questions, check with your doctor.

Tell your doctor if you have too frequent or persistent erections of the penis.

Tell your doctor if you have any nausea, vomiting, changes in skin color or swelling of the ankles.

Tell your doctor if you experience any breathing problems, including those while you sleep.

Regularly check your gums where the buccal system is applied to check for any abnormalities and report findings to your doctor.

Striant Side Effects

Symptoms of Overdose

Get emergency help immediately if any of the following symptoms of overdose occur:

• Blurred vision


• headache


• sudden and severe inability to speak


• seizures


• slurred speech


• temporary blindness


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

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

• Gum or mouth irritation

Less common

• Abnormal liver function test


• abnormal renal function


• bad unusual or unpleasant (after) taste


• bleeding gums


• blemishes on the skin, pimples


• blurred vision


• breast enlargement


• breast pain


• buccal inflammation


• change in taste


• cough


• crying


• depersonalization


• diarrhea


• difficulty breathing


• discouragement


• dry mouth


• dizziness


• dysphoria


• euphoria


• fear


• feeling sad or empty


• fever or chills


• gum blister


• gum pain


• headache


• hoarseness


• indigestion


• irritability;


• itching skin


• loss of appetite


• loss of interest or pleasure


• lower back or side pain


• mental depression


• mouth ulcers


• nausea


• nervousness


• noisy breathing


• paranoia


• painful or difficult urination


• passing of gas


• pounding in the ears


• quick to react or overreact emotionally


• rapidly changing moods


• redness and swelling of gums


• shortness of breath


• slow or fast heartbeat


• stomach cramps


• stomach pain, fullness or discomfort


• stinging of lips


• swelling of gums


• swelling or inflammation of the mouth


• swelling of the nose


• taste bitter


• tightness in chest


• tiredness


• toothache


• trouble concentrating


• trouble sleeping


• unusual tiredness or weakness


• vomiting


• wheezing

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: Striant 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 Striant resources

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

• Striant MedFacts Consumer Leaflet (Wolters Kluwer)


• Striant Prescribing Information (FDA)


• Striant Consumer Overview


• Testosterone Prescribing Information (FDA)


• Testosterone Professional Patient Advice (Wolters Kluwer)


• Testosterone Monograph (AHFS DI)


• AndroGel Prescribing Information (FDA)


• AndroGel Gel MedFacts Consumer Leaflet (Wolters Kluwer)


• Androderm Prescribing Information (FDA)


• Androderm Patch MedFacts Consumer Leaflet (Wolters Kluwer)


• Androgel Consumer Overview


• Axiron Solution MedFacts Consumer Leaflet (Wolters Kluwer)


• Axiron Consumer Overview


• Axiron Prescribing Information (FDA)


• Delatestryl MedFacts Consumer Leaflet (Wolters Kluwer)


• Delatestryl Prescribing Information (FDA)


• Depo-Testosterone MedFacts Consumer Leaflet (Wolters Kluwer)


• Depo-Testosterone Prescribing Information (FDA)


• Fortesta Gel MedFacts Consumer Leaflet (Wolters Kluwer)


• Fortesta Consumer Overview


• Testim Gel MedFacts Consumer Leaflet (Wolters Kluwer)


• Testim Prescribing Information (FDA)


• Testosterone Cypionate Prescribing Information (FDA)


• Testosterone Enanthate Prescribing Information (FDA)

Compare Striant with other medications

• Hypogonadism, Male

Vicon Forte

Pronunciation: MUL-ti-VYE-ta-mins/MIN-er-als
Generic Name: Multivitamins with Minerals
Brand Name: Examples include Protegra and Vicon Forte

Vicon Forte is used for:

Treating or preventing low levels of vitamins and minerals in the body. It may also be used for other conditions as determined by your doctor.

Vicon Forte is a vitamin and mineral supplement. It works by providing extra vitamins and minerals to the body.

Do NOT use Vicon Forte if:

• you are allergic to any ingredient in Vicon Forte

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

Before using Vicon Forte:

Some medical conditions may interact with Vicon Forte. 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

Some MEDICINES MAY INTERACT with Vicon Forte.

Ask your health care provider if Vicon Forte 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 Vicon Forte:

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

• Take Vicon Forte by mouth with or without food. If stomach upset occurs, take with food to reduce stomach irritation.


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

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

Important safety information:

• Do not take large doses of vitamins while you use Vicon Forte unless your doctor tells you to.


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

Possible side effects of Vicon Forte:

All medicines may cause side effects, but many people have no, or minor, side effects. No COMMON side effects have been reported with Vicon Forte. 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).

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

See also: Vicon Forte side effects (in more detail)

If OVERDOSE is suspected:

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

Proper storage of Vicon Forte:

Store Vicon Forte at room temperature. Store away from heat, moisture, and light. Do not store in the bathroom. Keep Vicon Forte out of the reach of children and away from pets.

General information:

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


• Vicon Forte 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.

This information is a summary only. It does not contain all information about Vicon Forte. 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 Vicon Forte resources

• Vicon Forte Side Effects (in more detail)
• Vicon Forte Use in Pregnancy & Breastfeeding
• Drug Images
• Vicon Forte Drug Interactions
• Vicon Forte Support Group
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