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Friday, 9 March 2012

Floxin

Generic Name: ofloxacin (oh FLOX a sin)

Brand Names: Floxin

What is ofloxacin?

Ofloxacin is in a group of antibiotics called fluoroquinolones (flor-o-KWIN-o-lones). Ofloxacin fights bacteria in the body.

Ofloxacin is used to treat bacterial infections that cause bronchitis, pneumonia, chlamydia, gonorrhea, skin infections, urinary tract infections, and infections of the prostate.

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

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

You should not use this medication if you have a history of myasthenia gravis, or if you are allergic to ofloxacin or similar antibiotics such as ciprofloxacin (Cipro), gemifloxacin (Factive), levofloxacin (Levaquin), moxifloxacin (Avelox), norfloxacin (Noroxin), and others.

Before taking ofloxacin, tell your doctor if you have kidney or liver disease, joint problems, myasthenia gravis, seizures or epilepsy, diabetes, low levels of potassium in your blood (hypokalemia), or a personal or family history of Long QT syndrome.

Avoid taking antacids, vitamin or mineral supplements, sucralfate (Carafate), or didanosine (Videx) powder or chewable tablets within 2 hours before or after you take ofloxacin. These other medicines can make ofloxacin much less effective when taken at the same time. Ofloxacin may cause swelling or tearing of a tendon (the fiber that connects bones to muscles in the body), especially in the Achilles' tendon of the heel. These effects may be more likely to occur if you are over 60, if you take steroid medication, or if you have had a kidney, heart, or lung transplant. Stop taking ofloxacin and call your doctor at once if you have sudden pain, swelling, tenderness, stiffness, or movement problems in any of your joints. Rest the joint until you receive medical care or instructions. Do not share this medication with another person (especially a child), even if they have the same symptoms you have.

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

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

heart rhythm disorder, especially if you take quinidine (Quin-G), disopyramide (Norpace), bretylium (Bretylol), procainamide (Pronestyl, Procan SR), amiodarone (Cordarone, Pacerone), or sotalol (Betapace);

a history of allergic reaction to an antibiotic;

muscle weakness or trouble breathing;

joint problems;

kidney or liver disease;

epilepsy or a history of seizures;

diabetes;

low levels of potassium in your blood (hypokalemia); or

a personal or family history of Long QT syndrome.

Ofloxacin can pass into breast milk and may harm a nursing baby. You should not breast-feed while you are using ofloxacin. FDA pregnancy category C. It is not known whether ofloxacin will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant while using this medication. Ofloxacin may cause swelling or tearing of a tendon (the fiber that connects bones to muscles in the body), especially in the Achilles' tendon of the heel. These effects may be more likely to occur if you are over 60, if you take steroid medication, or if you have had a kidney, heart, or lung transplant. Stop taking ofloxacin and call your doctor at once if you have sudden pain, swelling, tenderness, stiffness, or movement problems in any of your joints. Rest the joint until you receive medical care or instructions. Do not share this medication with another person (especially a child), even if they have the same symptoms you have.

How should I take ofloxacin?

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

Take ofloxacin with a full glass of water (8 ounces). Drink several extra glasses of fluid each day to prevent crystals from forming in the urine.

You may take ofloxacin with or without food, but take it at the same time each day.

If you are being treated for gonorrhea, your doctor may also have you tested for syphilis, another sexually transmitted disease.

Take this medication for the full prescribed length of time. Your symptoms may improve before the infection is completely cleared. Skipping doses may also increase your risk of further infection that is resistant to antibiotics. Ofloxacin will not treat a viral infection such as the common cold or flu.

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

Store at room temperature away from moisture and heat. Keep the bottle tightly closed when not in use.

See also: Floxin dosage (in more detail)

What happens if I miss a dose?

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 drowsiness, nausea, hot or cold feeling, confusion, and slurred speech.

What should I avoid while taking ofloxacin?

You may be taking certain other medicines that should not be taken at the same time as ofloxacin. Avoid taking the following medicines within 2 hours before or after you take ofloxacin. These other medicines can make ofloxacin much less effective when taken at the same time:

antacids that contain calcium, magnesium or aluminum (such as Tums, Mylanta, or Rolaids);

the ulcer medicine sucralfate (Carafate);

didanosine (Videx) powder or chewable tablets; or

vitamin or mineral supplements that contain calcium, iron, or zinc.

Avoid exposure to sunlight or tanning beds. Ofloxacin can make you sunburn more easily. Wear protective clothing and use sunscreen (SPF 30 or higher) when you are outdoors. Call your doctor if you have severe burning, redness, itching, rash, or swelling after being in the sun.

Antibiotic medicines can cause diarrhea, which may be a sign of a new infection. If you have diarrhea that is watery or bloody, stop taking ofloxacin and call your doctor. Do not use anti-diarrhea medicine unless your doctor tells you to.

Ofloxacin may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be alert.

Ofloxacin side effects

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat. Stop using ofloxacin and call your doctor at once if you have a serious side effect such as:

diarrhea that is watery or bloody;

seizure (convulsions);

confusion, hallucinations, anxiety, feeling resltess, tremors, insomnia, nightmares, unusual thoughts or behavior, feeling light-headed;

severe dizziness, fainting, fast or pounding heartbeat;

sudden pain, snapping or popping sound, bruising, swelling, tenderness, stiffness, or loss of movement in any of your joints;

easy bruising or bleeding;

fever, swollen glands, general ill feeling;

urinating less than usual or not at all;

numbness, burning pain, or tingly feeling in your hands or feet;

pale skin, dark colored urine, fever, weakness, jaundice (yellowing of the skin or eyes);;

the first sign of any skin rash, no matter how mild; or

severe skin reaction -- fever, sore throat, swelling in your face or tongue, burning in your eyes, skin pain, followed by a red or purple skin rash that spreads (especially in the face or upper body) and causes blistering and peeling.

Less serious side effects may include:

nausea, vomiting, mild diarrhea;

headache, dizziness;

changes in your sense of taste;

vaginal itching or discharge; or

mild skin itching.

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

What other drugs will affect ofloxacin?

Tell your doctor about all other medicines you use, especially:

a blood thinner such as warfarin (Coumadin, Jantoven);

cimetidine (Tagamet);

cyclosporine (Neoral, Sandimmune, Gengraf);

insulin or oral diabetes medication such as glyburide (Micronase, Diabeta, Glynase);

probenecid (Benemid);

theophylline (Elixophyllin, Theo-24, Theochron, Uniphyl);

an NSAID (non-steroidal anti-inflammatory drug) such as ibuprofen (Advil, Motrin), naproxen (Aleve, Naprosyn, Naprelan, Treximet), celecoxib (Celebrex), diclofenac (Arthrotec, Cambia, Cataflam, Voltaren, Flector Patch, Pennsaid, Solareze), indomethacin (Indocin), meloxicam (Mobic), and others; or

steroid medication (prednisone and others).

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

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

Floxin Prescribing Information (FDA)

Floxin Advanced Consumer (Micromedex) - Includes Dosage Information

Floxin Consumer Overview

Floxin MedFacts Consumer Leaflet (Wolters Kluwer)

Ofloxacin Professional Patient Advice (Wolters Kluwer)

Ofloxacin Monograph (AHFS DI)

Ofloxacin Prescribing Information (FDA)

Floxin I.V.

Compare Floxin with other medications

Anthrax
Anthrax Prophylaxis
Bladder Infection
Bone infection
Bronchitis
Campylobacter Gastroenteritis
Cervicitis
Chancroid
Chlamydia Infection
Epididymitis, Non-Specific
Epididymitis, Sexually Transmitted
Gonococcal Infection, Disseminated
Gonococcal Infection, Uncomplicated
Joint Infection
Kidney Infections
Methicillin-Resistant Staphylococcus Aureus Infection
Mycobacterium avium-intracellulare, Treatment
Nongonococcal Urethritis
Pelvic Inflammatory Disease
Plague
Pneumonia
Prostatitis
Salmonella Enteric Fever
Salmonella Gastroenteritis
Shigellosis
Skin Infection
Traveler's Diarrhea
Tuberculosis, Active
Urinary Tract Infection

Where can I get more information?

Your pharmacist can provide more information about ofloxacin.

See also: Floxin side effects (in more detail)

Thursday, 8 March 2012

Typhoid Vaccine

Class: Vaccines
ATC Class: J07AP01
VA Class: IM100
Brands: Typhim Vi, Vivotif

Introduction

Live, attenuated vaccine (Vivotif)¹⁰¹ ¹⁰² ¹⁰³ ^b and inactivated vaccine (Typhim Vi).¹⁰¹ ¹⁰² ¹²³ ^b Typhoid vaccine live oral (Vivotif) contains the Ty21a strain of Salmonella typhi.¹⁰¹ ¹⁰² ¹⁰³ Parenteral typhoid Vi polysaccharide vaccine (Typhim Vi) contains purified cell surface polysaccharide antigens extracted from S. typhi of the Ty2 strain.¹⁰¹ ¹⁰² ¹²³ Typhoid vaccines are used to stimulate active immunity to typhoid fever.¹⁰¹ ¹⁰² ¹⁰³ ¹²³ Different typhoid vaccines (e.g., whole-cell vaccines) may be available in other countries.¹⁰¹ ¹⁰² ¹¹⁴ ¹²⁶ ¹³⁴ ¹³⁵

Uses for Typhoid Vaccine

Prevention of Typhoid Fever

Prevention of typhoid fever in individuals at risk of intimate exposure to a known typhoid carrier (e.g., continued household contact), in those traveling to areas where typhoid fever is endemic because of poor food or water sanitation, and in laboratory workers with frequent contact with Salmonella typhi bacilli.¹⁰² ¹⁰³ ¹²³ ^b

Typhoid fever is an acute, life-threatening febrile illness caused by S. typhi bacteria transmitted via food and/or water contaminated with feces, urine, vomitus, or respiratory secretions from typhoid fever carriers.^a Typhoid fever is uncommon in the US, but is endemic in many less well-developed areas of the world that have poor sanitation and primitive water systems.¹⁰¹ ¹³⁷ WHO estimates that about 22 million cases of typhoid fever occur with about 200,000 related deaths annually.¹⁰¹ ^c Approximately 2–4% of individuals with acute typhoid develop a chronic carrier state.¹⁰³ ¹²³ CDC receives reports of about 400 cases of typhoid fever each year in the US, mostly among recent travelers to other countries.¹⁰¹ ¹⁰² ^b

USPHS Advisory Committee on Immunization Practices (ACIP) and AAP do not currently recommend routine immunization against typhoid fever for individuals residing in the US.¹⁰² ¹⁰³ ¹²³ Although immunization against typhoid fever was recommended in the past for individuals in the US attending summer camps or residing in areas where natural disasters (e.g., flooding) had occurred or for control of common-source outbreaks of typhoid fever, this no longer is considered necessary because of the low probability of exposure in the US.¹⁰² ¹⁰³ ¹²³ Routine immunization against typhoid fever is warranted for sewage workers only in areas with endemic typhoid.¹⁰²

ACIP and AAP recommend vaccination using oral live typhoid vaccine (Vivotif) or parenteral inactivated typhoid vaccine (Typhim Vi) for adults, adolescents, and children at high risk of exposure to S. typhi bacilli.¹⁰¹ ¹⁰² ^b Efficacy of these vaccines appears to be comparable when administered as recommended;¹⁰² ¹⁰⁵ ¹⁰⁷ ¹⁰⁹ ¹¹¹ ¹¹⁴ ¹¹⁵ ¹¹⁶ ¹¹⁷ ¹¹⁸ ¹¹⁹ ¹²⁰ ¹²¹ ¹²³ ¹²⁴ ¹²⁵ ¹²⁶ however, the vaccines have different contraindications (see Contraindications under Cautions) and different minimum age limits for use in children (see Pediatric Use under Cautions).¹⁰² ¹⁰³ ¹²³

Other factors to consider when selecting a typhoid vaccine include immunization schedule, response time, patient compliance, storage facilities, and immune status of the vaccinee.¹⁰² ¹²³ ¹²⁶ Because Vivotif is self-administered over a 1-week period and compliance errors (i.e., dosing errors, improper storage) have been reported, Typhim Vi may be preferred in patients in whom compliance is likely to be a problem.¹³¹

Individuals with acute typhoid infection and those who are chronic typhoid carriers should not receive typhoid vaccine.¹⁰³ ¹²³

Vivotif and Typhim Vi will not prevent typhoid fever caused by Salmonella species other than S. typhi (e.g., S. paratyphi type A or B) and will not prevent infections caused by other bacteria known to cause enteric disease.¹⁰³ ¹²³

Preexposure Vaccination Against Typhoid Fever in High-risk Groups

Preexposure vaccination in individuals who are or will be at high risk of exposure to S. typhi.¹⁰¹ ¹⁰² ^b

Household contacts of known typhoid carriers should be vaccinated with typhoid vaccine because of increased risk of exposure to typhoid fever.¹⁰² ¹⁰³ ¹²³ ^b

Travelers to areas where there is a recognized risk of exposure to typhoid fever (e.g., many countries in Africa, Asia, Central and South America) should be vaccinated against typhoid fever.¹⁰¹ ¹⁰³ ¹²³ ¹³⁷ ^b Although vaccination is not currently required for international travel,¹⁰¹ ¹³⁷ it is recommended for travelers who may have prolonged exposure to contaminated food and drink in areas with persistent typhoid epidemics or in smaller villages or rural areas outside the usual tourist itinerary.¹⁰¹ ¹²³ ¹³⁷ ^b In addition to vaccination, travelers should use caution in selecting food and water in these areas since the vaccines are not 100% effective and vaccine-induced immunity can be overwhelmed by a large inoculum of S. typhi.¹⁰¹ ¹⁰³ ¹²³ ^b (See Limitations of Vaccine Effectiveness under Cautions.)

HIV-infected individuals should not receive Vivotif since the vaccine contains live, attenuated bacteria.¹⁰² ¹⁰³ ¹²² If typhoid vaccine is indicated, HIV-infected individuals may receive Typhim Vi.¹⁰² ¹²² USPHS/IDSA Prevention of Opportunistic Infections Working Group recommends use of Typhim Vi in HIV-infected individuals at risk of exposure to typhoid fever.¹³⁶ (See Individuals with Altered Immunocompetence under Cautions.)

Typhoid Vaccine Dosage and Administration

Administration

Vivotif is administered orally;¹⁰³ Typhim Vi is administered by IM injection.¹²³

Oral Administration

Vivotif: Administer orally.¹⁰¹ ¹⁰² ¹⁰³ ^b ^d Do not administer parenterally.¹⁰³

Take on an empty stomach (approximately 1 hour before or 2 hours after a meal).¹⁰¹ ¹⁰² ¹⁰³ ¹¹⁴ ^b ^d

Do not chew or open the enteric-coated capsules.¹⁰³ ¹¹⁴ ^d Swallow whole with cool or lukewarm (≤37°C [body temperature]) liquid (water).¹⁰¹ ¹⁰² ¹⁰³ ^b ^d

Do not drink alcohol within 2 hours after the dose.^d (See Specific Drugs under Interactions.)

It is essential that remaining capsules be stored in a refrigerator until the vaccination series is completed.¹⁰³ (See Storage under Stability.)

IM Administration

Typhim Vi: Administer by IM injection.¹⁰¹ ¹⁰² ¹²³ ^b Do not administer IV.¹²³

IM injections preferably should be made into the deltoid area in adults and into the deltoid or the vastus lateralis in children.¹²³ To ensure delivery into muscle, IM injections should be made at a 90° angle to the skin using a needle length appropriate for the individual's age and body mass.¹⁰⁰

Administer undiluted.¹²³ Do not mix with any other vaccine or solution.¹⁰⁰ ¹²³ ^b

Avoid use of the gluteal area or any area where there may be a nerve trunk.¹²³ Generally, do not administer vaccines into buttock muscle in children because of potential for injection-associated injury to the sciatic nerve.¹⁰⁰

Avoid injection of vaccines into or near blood vessels.¹²³

Dosage

Dose and dosing schedule vary according to the individual's age and specific vaccine administered (Vivotif, Typhim Vi).¹⁰³ ¹²³ ^b Follow dosage recommendations for the specific preparation used.¹⁰²

Pediatric Patients

Preexposure Vaccination Against Typhoid Fever in High-risk Groups

Children and Adolescents 6–18 Years of Age (Vivotif)

Oral

Primary immunization consists of 4 doses.¹⁰¹ ¹⁰² ¹⁰³ ^b Each dose consists of one enteric-coated capsule.¹⁰² ¹⁰³

Give first dose on a selected date; give second, third, and fourth doses every other day after the first dose over a 1-week period.¹⁰¹ ¹⁰² ¹⁰³ ^b

Primary immunization with the recommended vaccination series before an expected exposure to typhoid fever ensures the highest level of protection.¹⁰² ¹⁰³ Those who complete the 4-dose series at least 1 week prior to possible typhoid exposure probably will be protected.¹⁰² ¹⁰³ ^b ^c ^d

Data not available concerning use of Vivotif as a booster in individuals who received primary immunization with a different typhoid vaccine.¹⁰² ¹⁰³ ACIP states that the 4-dose Vivotif vaccination series is a reasonable alternative for booster immunization in individuals previously vaccinated with a parenteral inactivated typhoid vaccine.¹⁰²

Duration of immunity and need for subsequent doses not fully determined.¹⁰² ¹⁰³ ^b For travelers or individuals at continued or repeated risk of exposure to typhoid fever, additional (booster) doses (i.e., 4-dose vaccination series) are recommended every 5 years.¹⁰² ¹⁰³ ^b (See Duration of Immunity under Cautions.)

Children and Adolescents 2 –18 Years of Age (Typhim Vi)

Primary immunization consists of a single 25-mcg dose.¹⁰² ¹²³ ^b Each dose consists of 0.5 mL from the commercially available prefilled single-dose syringe or multidose vial.¹⁰² ¹²³ ^b

Those who receive the recommended dose given at least 2 weeks prior to possible exposure to typhoid fever probably will be protected.¹⁰² ¹²³ ^b ^c

Data not available concerning use of Typhim Vi for booster immunization in individuals who received primary immunization with a different typhoid vaccine.¹⁰² ¹²³ ^b ACIP states that a single dose of Typhim Vi is a reasonable alternative as a booster for individuals previously vaccinated with another parenteral inactivated typhoid vaccine.¹⁰²

Duration of immunity and need for subsequent doses not fully determined.¹⁰² ¹²³ ¹¹⁴ ^b For travelers or individuals at continued or repeated risk of exposure to typhoid fever, an additional (booster) dose of 0.5 mL is recommended every 2 years.¹⁰² ¹²³ ¹¹⁴ ^b (See Duration of Immunity under Cautions.)

Adults

Preexposure Vaccination Against Typhoid Fever in High-risk Groups

Adults ≥19 Years of Age (Vivotif)

Oral

Primary immunization consists of 4 doses.¹⁰² ¹⁰³ ^b Each dose consists of one enteric-coated capsule.¹⁰² ¹⁰³

Give first dose on a selected date; give second, third, and fourth doses every other day after the first dose over a 1-week period.¹⁰² ¹⁰³ ^b

Data not available concerning use of Vivotif as a booster in individuals who received primary immunization with a different typhoid vaccine.¹⁰² ¹⁰³ ^b ACIP states that the 4-dose Vivotif vaccination series is a reasonable alternative as a booster for individuals previously vaccinated with a parenteral inactivated typhoid vaccine.¹⁰²

Duration of immunity and need for subsequent doses not fully determined.¹⁰² ¹⁰³ ¹¹⁴ ^b For travelers or individuals at continued or repeated risk of exposure to typhoid fever, additional (booster) doses (i.e., 4-dose vaccination series) are recommended every 5 years.¹⁰³ ¹¹⁴ ^b (See Duration of Immunity under Cautions.)

Adults ≥19 Years of Age (Typhim Vi)

Primary immunization consists of a single 25-mcg dose.¹⁰² ¹²³ ^b Each dose consists of 0.5 mL from the commercially available prefilled single-dose syringe or multidose vial.¹⁰² ¹²³ ^b

Those who receive the recommended single dose at least 2 weeks prior to possible exposure to typhoid fever probably will be protected.¹⁰² ¹²³ ^b

Duration of immunity and need for subsequent doses not fully determined.¹⁰² ¹²³ ^b For travelers or individuals at continued or repeated risk of exposure to typhoid fever, an additional (booster) dose of 0.5 mL is recommended every 2 years.¹²³ ^b (See Duration of Immunity under Cautions.)

Special Populations

Hepatic Impairment

No specific dosage recommendations.

Renal Impairment

No specific dosage recommendations.

Geriatric Patients

No specific dosage recommendations.

Cautions for Typhoid Vaccine

Contraindications

Oral live typhoid vaccine (Vivotif): Hypersensitivity to any ingredient in the formulation.¹⁰¹ ¹⁰³ Also contraindicated in individuals with altered immunocompetence and in those with acute febrile illness.¹⁰¹ ¹⁰² ¹⁰³

Parenteral inactivated typhoid vaccine (Typhim Vi): Hypersensitivity to any ingredient in the formulation.¹⁰¹ ¹²³ Also contraindicated in individuals with previous hypersensitivity reactions to any typhoid vaccine.¹⁰¹ ¹⁰² ¹²³ ^b

Warnings/Precautions

Warnings

Individuals with Altered Immunocompetence

Because severe complications have been reported following vaccination with live, attenuated virus or bacterial vaccines in individuals with altered immunocompetence (e.g., patients with leukemia, lymphoma, generalized malignancy, asymptomatic or symptomatic HIV infection, those receiving immunosuppressive therapy)¹⁰¹ and because safety of oral live typhoid vaccine (Vivotif) has not been established in immunocompromised individuals, this vaccine should not be used in such individuals.¹⁰¹ ¹⁰² ¹⁰³ ¹²² However, ACIP states that Vivotif can be used, if indicated, in patients who have altered immunocompetence because of asplenia, renal failure, diabetes, alcoholism, or alcoholic cirrhosis.¹²²

If typhoid vaccination is considered necessary in individuals with altered immunocompetence, parenteral inactivated typhoid vaccine (Typhim Vi) theoretically would be a safer alternative than the oral vaccine.¹⁰² ¹²² However, the vaccine may be less immunogenic in immunocompromised individuals than in immunocompetent individuals.¹²² ¹²³ ACIP currently states that recommendations concerning use of parenteral inactivated typhoid vaccine in individuals with altered immunocompetence generally are the same as those for individuals who are not immunocompromised.¹²²

Individuals with GI Disorders

Oral live typhoid vaccine (Vivotif) should not be used in individuals with acute GI illness since the vaccine requires replication in the gut for effectiveness.¹⁰³ ^b ^d Postpone initiating the vaccination series in patients with persistent diarrhea or vomiting.¹⁰³ ^d

Sensitivity Reactions

Hypersensitivity Reactions

Allergic reactions (e.g., anaphylactic shock, pruritus, rash, urticaria, difficulty breathing, hypotension, serum sickness) have been reported rarely with typhoid vaccine.¹⁰³ ¹²³

A history of previous sensitivity reactions to typhoid vaccine should be obtained prior to administration.¹⁰² ¹²³

Epinephrine and other appropriate agents should be readily available in case anaphylaxis or other serious allergic reaction occurs.¹²³

General Precautions

Transmission of Vaccine Bacteria

Oral typhoid vaccine (Vivotif) contains live, attenuated bacteria.¹⁰³ Secondary transmission of vaccine bacteria has not been documented following administration of Vivotif; however, these organisms may be shed transiently in the stools of vaccinees.¹⁰² ¹⁰³

Concomitant Illness

A decision to administer or delay vaccination in an individual with a current or recent febrile illness depends on the severity of symptoms and etiology of the illness.¹⁰⁰

Manufacturer of Vivotif states that the vaccine should not be administered to individuals during an acute febrile illness. ¹⁰³ Manufacturer of Typhim Vi states that the vaccine may be given to individuals with acute infection or febrile illness if withholding the vaccine poses greater risk to the patient.¹²³

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, but vaccination should be deferred in individuals with moderate or severe acute illness (with or without fever) until they have recovered from the acute phase of the illness.¹⁰⁰

Individuals with Bleeding Disorders

Parenteral inactivated typhoid vaccine (Typhim Vi): Because bleeding may occur following IM administration in individuals with thrombocytopenia or a bleeding disorder (e.g., hemophilia) or in those receiving anticoagulant therapy, use caution in such individuals.¹⁰⁰ ¹²³

ACIP states that vaccines may be given IM to individuals who have bleeding disorders or are receiving anticoagulant therapy if a clinician familiar with the patient's bleeding risk determines that the preparation can be administered with reasonable safety.¹⁰⁰ In these cases, use a fine needle (23 gauge) to administer the vaccine and apply firm pressure to the injection site (without rubbing) for ≥2 minutes.¹⁰⁰ If patient is receiving antihemophilia therapy, administer the IM vaccine shortly after a scheduled dose of such therapy.¹⁰⁰

Advise individual and/or their family about the risk of hematoma from IM injections.¹⁰⁰

Limitations of Vaccine Effectiveness

May not protect all vaccine recipients against typhoid fever infection.¹⁰³ ¹²³ ^b Vaccine-induced immunity can be overwhelmed by large inocula of S. typhi.¹⁰² Even travelers who have been immunized against typhoid fever should take precautions to avoid contact with or ingestion of potentially contaminated food or water.¹⁰³

Oral live typhoid vaccine (Vivotif): Optimum immune response may not be achieved unless the complete 4-dose vaccination series is used.¹⁰¹ ¹⁰² ¹⁰³ ^b Individuals who complete the 4-dose series at least 1 week prior to possible typhoid exposure probably will be protected.¹⁰¹ ¹⁰² ¹⁰³ ^b

Parenteral inactivated typhoid vaccine (Typhim Vi): Individuals who receive a single dose given at least 2 weeks prior to possible typhoid exposure probably will be protected.¹⁰¹ ¹⁰² ¹²³

May not prevent infection in individuals who do not achieve protective antibody titers; the minimum titer needed to confer immunity has not been established.¹⁰³ ¹²³

Vivotif and Typhim Vi provide protection only against S. typhi.¹⁰³ ¹²³ These vaccines do not provide protection against other Salmonella species (e.g., S. paratyphi A or B).¹²³

Duration of Immunity

Duration of protection and need for subsequent doses after initial and additional (booster) doses of typhoid vaccine not fully determined.¹⁰² ¹⁰³ ¹¹⁴ ¹²³ Natural infection with S. typhi generally confers lifelong immunity; however, the nature of this immunity is complex and includes both humoral and cell-mediated components.^a

Oral live typhoid vaccine (Vivotif): Although additional long-term follow-up studies are needed, limited evidence suggests that protective levels of antibodies following the recommended 4-dose vaccination series may persist for at least 5 years.¹⁰² ¹⁰³ Additional (booster) doses (i.e., 4-dose oral vaccination series) of Vivotif recommended every 5 years if continued or renewed exposure to typhoid fever is expected.¹⁰² ¹⁰³

Parenteral inactivated typhoid vaccine (Typhim Vi): Limited data indicate that antibody titers remain elevated for at least 12 months after a single dose in children 5–15 years of age residing in typhoid-endemic areas and for at least 36 months in healthy US adults.¹²³ ¹²⁸ ¹²⁹ Additional (booster) dose of Typhim Vi recommended every 2 years if continued or renewed exposure to typhoid fever is expected.¹²³

Improper Storage and Handling

Improper storage or handling of vaccines may result in loss of vaccine potency and reduced immune response in vaccinees.¹⁰⁰

Oral live typhoid vaccine (Vivotif): Unstable when exposed to ambient temperatures.¹⁰³ ¹²⁶ ¹³¹ Remaining capsules must be stored in a refrigerator until the vaccination series is completed.¹⁰³ Do not administer Vivotif that has been mishandled or has not been stored at the recommended temperature (2–8°C).¹⁰³ ¹²⁶ ¹³¹ (See Storage under Stability.)

Parenteral inactivated typhoid vaccine (Typhim Vi): Not adversely affected by elevated temperatures (e.g., those that occur in tropical areas).¹²⁴ ¹²⁶ Therefore, the parenteral vaccine may be preferred in situations in which continuous refrigeration cannot be ensured.¹²⁴ ¹²⁶

Inspect all vaccines upon delivery and monitor during storage to ensure that the appropriate temperature is maintained.¹⁰⁰

Specific Populations

Pregnancy

Oral live typhoid vaccine (Vivotif) and parenteral inactivated typhoid vaccine (Typhim Vi): Category C.¹⁰³ ¹²³

Safety data not available on use of typhoid vaccines in pregnant women.¹⁰¹ ¹⁰² ^b Typhoid vaccine should be given to pregnant women only if clearly needed.¹⁰³ ¹²³

AAP states that Vivotif is contraindicated in pregnant women.^b

Because Typhim Vi is an inactivated vaccine, the theoretical risk to the fetus is expected to be low.¹⁰⁰ AAP states that use of Typhim Vi may be considered on an individual basis.^b When giving a vaccine during pregnancy, delaying vaccination until the second or third trimester, if possible, is a reasonable precaution to minimize the possibility of teratogenicity.¹²³ ^b

Lactation

Not known whether antigens contained in typhoid vaccine are distributed into milk following oral or IM administration.¹⁰³ ¹²³ Use with caution in nursing women.¹⁰³ ¹²³

Because inactivated vaccines (e.g., Typhim Vi) do not multiply within the body, they should not pose any unusual problems for lactating women or their infants.¹⁰⁰ ¹⁰¹

The manufacturers state that there currently are no data to warrant use of typhoid vaccines in nursing women in an attempt to provide passive transfer of antibodies to protect an infant from typhoid fever.¹⁰³ ¹²³

Pediatric Use

Oral live typhoid vaccine (Vivotif): Safety and efficacy not established in children <6 years of age.¹⁰² ¹⁰³ Although efficacy not established, limited evidence indicates adverse effects were uncommon when the vaccine was used in children 1–5 years of age†.¹⁰² Has not been studied in children <1 year of age.¹⁰²

Parenteral inactivated typhoid vaccine (Typhim Vi): Safety and efficacy not established in children <2 years of age.¹⁰² ¹²³ Has not been studied in children <1 year of age.¹⁰¹ ¹⁰²

Common Adverse Effects

Oral live typhoid vaccine (Vivotif): Abdominal pain, nausea, headache, fever, diarrhea, vomiting, skin rash.¹⁰¹ ¹⁰² ¹⁰³ ¹¹⁴ ^b ^d

Parenteral inactivated typhoid vaccine (Typhim Vi): Injection site reactions (pain, tenderness, erythema, induration),¹⁰² ¹²³ ¹²⁵ ¹³⁰ ¹³⁵ ^b malaise/generalized aches,¹²³ ¹²⁹ ¹³⁰ headache,¹⁰² ¹²³ ¹²⁵ ¹³⁰ ¹³⁵ ^b myalgia/muscle aches,¹²³ ¹³⁰ nausea,¹²³ ¹²⁵ ¹³⁰ diarrhea,¹²³ ¹³⁰ feverishness,¹²³ ¹³⁰ decreased activity/lethargy,¹²³ ¹³⁰ vomiting.¹²³

Interactions for Typhoid Vaccine

Live Vaccines

Oral live typhoid vaccine (Vivotif): May be administered simultaneously with or at any interval before or after a parenteral live vaccine (e.g., measles, mumps, and rubella virus vaccine live [MMR], varicella virus vaccine live, yellow fever vaccine).¹⁰⁰ Data not available regarding the immunogenicity of Vivotif administered concurrently or within 30 days of other live virus vaccines.¹⁰⁰ However, ACIP and AAFP state that if use of Vivotif is warranted, it should not be delayed because of administration of other live virus vaccines (injectable or intranasal).¹⁰⁰ ¹⁰²

Parenteral inactivated typhoid vaccine (Typhim Vi): Specific interaction studies involving Typhim Vi and other vaccines have not been conducted to date.¹²³ However, since Typhim Vi is an inactivated vaccine, it generally can be administered simultaneously with (using different syringes and different injection sites) or at any interval before or after live vaccines.¹⁰⁰

Inactivated Vaccines and Toxoids

Oral live typhoid vaccine (Vivotif): Can be administered simultaneously with or at any interval before or after inactivated vaccines.¹⁰⁰

Parenteral inactivated typhoid vaccine (Typhim Vi): Specific drug interaction studies involving Typhim Vi and other vaccines commonly administered prior to international travel (e.g., hepatitis A, meningococcal, poliovirus, tetanus) have not been conducted to date.¹²³ However, since Typhim Vi is an inactivated vaccine, it generally can be administered simultaneously with (using different syringes and different injection sites) or at any interval before or after other inactivated vaccines.¹⁰⁰

Specific Drugs

Drug	Interaction	Comments
Alcohol	Vivotif: Alcohol may affect dissolution of the vaccine capsules and may inactivate the vaccine^d	Vivotif: Avoid alcohol for 2 hours after each vaccine dose^d
Anti-infective agents (e.g., sulfonamides)	Vivotif: Potential for anti-infectives with activity against S. typhi to inhibit immune response to the vaccine¹⁰³ Typhim Vi: Manufacturer states that specific drug interaction studies involving the vaccine and other drugs (e.g., anti-infectives) not conducted to date¹²³	Vivotif: Manufacturer states do not use in individuals receiving anti-infectives;¹⁰³ ^d ACIP, CDC, and AAFP state an interval of ≥24 hours should elapse between administration of an anti-infective dose and the vaccine;¹⁰⁰ ¹⁰¹ ¹⁰² AAP states that anti-infectives should be avoided for ≥24 hours before the first dose and for 7 days after the fourth vaccine dose^b
Antimalarial agents (e.g., chloroquine, mefloquine, proguanil)	Vivotif: Potential for antimalarials with antibacterial activity against Salmonella to inhibit the immune response to the vaccine¹⁰³ Vivotif: Although mefloquine inhibits growth of S. typhi in vitro, including the Ty21a strain contained in the vaccine,¹⁰² ¹³² ¹³³ no clinical evidence to date that mefloquine or chloroquine interferes with the immune response to the vaccine¹⁰³ ^b Vivotif: Concurrent use of proguanil (200 mg daily; not commercially available in the US as a single-entity preparation) with the vaccine resulted in decreased immune response¹⁰³ Typhim Vi: Manufacturer states specific drug interaction studies involving the vaccine and other drugs (e.g., antimalarial agents) not conducted to date¹²³	Vivotif: Manufacturer states the vaccine may be administered in patients receiving mefloquine¹⁰³ To minimize the potential for an inhibitory effect, ACIP states the vaccine should be administered ≥24 hours before or after a mefloquine dose;¹⁰⁰ ¹⁰² ¹³² ¹³³ AAP states mefloquine may be administered simultaneously with the vaccine^b Vivotif: Although an interval of ≥7 days was previously recommended between vaccination and initiation of chloroquine antimalarial prophylaxis, more recent evidence indicates special precautions not necessary¹⁰² ¹⁰³ ¹³² ¹³³ ^b Vivotif: Manufacturer and AAP state that proguanil therapy should be delayed until ≥10 days after the fourth vaccine dose¹⁰³ ^b
Hepatitis A (HepA) vaccine	Vivotif: Data not available regarding simultaneous administration with HepA vaccine¹⁰³ Typhim Vi: Concomitant administration of HepA vaccine and parenteral inactivated typhoid vaccine does not appear to affect the immune response or adverse reactions to the vaccines^e
Immune globulin (IGIM, IGIV) or specific immune globulin (HBIG, RIG, TIG, VZIG)	Vivotif: No evidence that immune globulin preparations interfere with the immune response to the vaccine¹⁰⁰ ¹⁰¹ ¹⁰² Typhim Vi: Specific drug interaction studies not available¹²³	Vivotif: May be administered simultaneously with or at any time before or after antibody-containing preparations without a substantial decrease in the immune response to the vaccine¹⁰⁰ ¹⁰¹ Typhim Vi: May be administered simultaneously (using different syringes and different injection sites) or at any time before or after immune globulins¹⁰⁰
Immunosuppressive agents (e.g., alkylating agents, antimetabolites, corticosteroids, radiation)	Typhim Vi: Immune response may be reduced in patients receiving immunosuppressive agents¹²² ¹²³	Vivotif: Contraindicated in patients receiving immunosuppressive therapy¹⁰² ¹⁰³ ¹²² If typhoid vaccination is considered necessary in individuals receiving immunosuppressive agents, Typhim Vi is recommended¹⁰² ¹²²
Measles, mumps, and rubella vaccine (MMR)	Vivotif: Data not available regarding the immunogenicity of oral live typhoid vaccine administered concurrently or within 30 days of MMR ¹⁰⁰ ¹⁰²	Vivotif: May be administered simultaneously with or at any interval before or after MMR¹⁰⁰ ¹⁰² Typhim Vi: May be administered simultaneously with (using different syringes and different injection sites) or at any interval before or after MMR¹⁰⁰
Meningococcal vaccine	Vivotif: Data not available regarding simultaneous administration with meningococcal vaccine¹⁰³ Typhim Vi: Has been administered concomitantly with MCV4 (Menactra) without reduced antibody response or increased adverse effects^g	Typhim Vi: May be administered simultaneously with MCV4 (Menactra) or at any interval before or after meningococcal vaccine (using different syringes and different injection sites)^g
Poliovirus vaccine live oral (OPV; no longer commercially available in the US)	Vivotif: Although there is a theoretical risk that oral typhoid vaccine may interfere with the immune response to OPV,¹⁰⁹ no evidence that OPV suppresses the immune response to typhoid vaccine¹⁰³	Vivotif: Some experts suggest that ≥2 weeks should elapse between the last dose of Vivotifand OPV ¹⁰⁹
Tetanus toxoid	Data not available regarding simultaneous administration of tetanus vaccine and Vivotif or Typhim Vi¹⁰³ ¹²³
Varicella vaccine	Vivotif: Specific data not available regarding immunogenicity of oral live typhoid vaccine administered concurrently or within 30 days of varicella vaccine¹⁰⁰ ¹⁰² Typhim Vi: Since this typhoid vaccine is an inactivated vaccine, interactions with live vaccines such as varicella vaccine are unlikely¹⁰⁰	Vivotif: May be administered simultaneously with or at any interval before or after varicella vaccine¹⁰⁰ Typhim Vi: May be administered simultaneously (using different syringes and different injection sites) or at any interval before or after varicella vaccine¹⁰⁰
Yellow fever vaccine	Vivotif: Although specific data not available regarding simultaneous administration, a bivalent vaccine (not commercially available in the US) containing a live oral typhoid vaccine and a cholera vaccine has been administered concomitantly with yellow fever vaccine without a decrease in immune response to the typhoid vaccine or an increase in adverse effects^f Typhim Vi: Yellow fever va

Balneum Plus Bath Oil

Balneum Plus

Active substances: lauromacrogols 15 %, soya oil 82.95 %

Read all of this leaflet carefully before you start using this medicine.

Keep this leaflet. You may need to read it again.

If you have any further questions, ask your doctor or pharmacist.

This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.

If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

In this leaflet:

1. What Balneum Plus is and what it is used for

2. Before you use Balneum Plus

3. How to use Balneum Plus

4. Possible side effects

5. How to store Balneum Plus

6. Further information

What Balneum Plus Is And What It Is Used For

Balneum Plus is a bath additive that contains lauromacrogols and soya oil and is used for the treatment of dry skin disorders such as eczema and dermatitis where itching is a problem. Balneum Plus rapidly relieves symptoms associated with dry, itchy skin whilst also cleansing and helping to protect the skin against further drying.

Soya oil is an emollient which soothes and softens dry skin by helping to replace lost oils.

The oil forms tiny droplets in the water which leaves a thin film on your skin. This film helps to stop your skin drying out and so makes it feel soft.

The lauromacrogols are local anaesthetics for the relief of itching associated with eczema, dermatitis and problem dry skin.

Before You Use Balneum Plus

Do not use Balneum Plus

If you are allergic (hypersensitive) to soya, peanut or any of the other ingredients.

If you suffer from fresh pustular forms of Psoriasis (Psoriasis pustulosa).

All full baths - including those to which Balneum Plus has been added - should only be taken after consultation with your doctor in the following cases: major skin injuries, acute skin diseases of unknown cause, feverish and infectious diseases, heart failure and high blood pressure.

If the above applies to you, do not use this medicine and talk to your doctor.

Take special care with Balneum Plus

Avoid getting Balneum Plus in your eyes, however, if this should occur, rinse immediately with clean water.

If eye irritation remains please see your doctor.

Undiluted Balneum Plus should not be swallowed. If this happens talk to your doctor or pharmacist immediately.

Make sure the bath or shower water is not too hot, as this can make your skin condition worse.

Take care not to slip in the bath or shower.

Always clean the bath immediately after you have used Balneum Plus. To do this rinse thoroughly with hot water and then clean with a household cleaner.

If your symptoms do not get better, go and see your doctor.

Using other medicines

There are no known interactions when using Balneum Plus with other medicines but please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.

Pregnancy and breast-feeding

Ask your doctor or pharmacist for advice before taking any medicine.

You may use Balneum Plus whilst you are pregnant.

Driving and using machines

Balneum Plus is not expected to have any effect on your ability to drive or use machines.

Important information about some of the ingredients of Balneum Plus

Due to its propylene glycol content this medicine may cause skin irritation.

Balneum Plus contains soya oil: If you are allergic to peanut or soya, do not use this, medicinal product.

The perfume contains benzylbenzoate which may be mildly irritant to the skin, eyes and mucous membranes.

How To Use Balneum Plus

Always use Balneum Plus exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.

Balneum Plus is for external use by patients of all ages.

Always shake the bottle before using Balneum Plus to make sure the ingredients are well mixed.

Pour the appropriate amount of Balneum Plus liquid into the bath as the bath is filling (please see below for correct measurements), be careful the water is not too hot.

Stay in the bath for at least 10 minutes.

Do not use soap since this will remove Balneum Plus from your skin and can also dry the skin.

If only a small area of skin is affected, you may be able to bathe the affected area in a bowl or sink.

Measurements:

For a full bath (Adults dose) - 1 capful (about 20 ml)

For a child's or baby's bath - 1/4 of a capful (about 5 ml)

For a partial bath in a bowl or sink - 1/8 of a capful (about 2.5 ml)

If you have very dry skin, you can use two or three times the above amounts.

Balneum Plus can also be used in the shower.

In this case the liquid should be evenly applied over the body without dilution and then rinsed off under the shower.

After bathing or showering gently pat dry with a towel. If you wipe or rub your skin too much the Balneum Plus will not work as well.

Adults and children should bathe or shower with Balneum Plus at least 3 times a week or as often as required. Your doctor will advise you how often you should use Balneum Plus depending on how severe your skin condition is. For babies and infants a daily bath is recommended.

Duration of treatment

Your doctor will tell you for how long you need to use Balneum Plus.

If you have any further questions on the use of this product, ask your doctor or pharmacist.

Possible Side Effects

Like all medicines, Balneum Plus can cause side effects, although not everybody gets them.

Very rarely during use there may be cases of reddening, itching and burning.

In very rare cases soya oil may cause allergic reactions.

If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

How To Store Balneum Plus

Keep out of the reach and sight of children.

Do not use Balneum Plus after the expiry date which is stated on the label and the carton after EXP.

The expiry date refers to the last day of that month.

You should store Balneum Plus in its original pack.

Ask your pharmacist how to dispose of medicines no longer required.

These measures will help to protect the environment.

Further Information

What Balneum Plus contains

The active substances are soya oil 82.95% and lauromacrogols 15%.

The other ingredients are ascorbyl palmitate, glyceryl stearate citrate, propylene glycol and perfume oil.

What Balneum Plus looks like and contents of the pack

Balneum Plus is a clear bath oil.

Your medicinal product comes in either 20 ml, 95 ml, 100 ml, 150 ml, 200 ml, 225 ml, 250 ml, 300 ml, 500 ml, 600 ml, and 1000 ml high density polyethylene bottles with a screw cap and also in 10 ml and 20 ml foil laminate sachets and 20 ml polyethylene/foil blisters.

Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Almirall Hennal GmbH

Scholtzstraße 3

21465 Reinbek

Germany

Tel:+49 -40 727 04-0

Fax:+49 -40 722 92 96

This leaflet was last approved in: 01.07.2010

OTHER INFORMATION

Self Help Measures

Eczema and dermatitis have many different causes and there are various self help measures you can adopt.

If you want to find out more, you may find the following organisation helpful:

National Eczema Society

Hill House

Highgate Hill

London

N 19 5 NA

Telephone Number:020 7281 3553

8000xxxx/ GB / 0410

Sunday, 4 March 2012

Tetracaine

Class: Local Anesthetics
ATC Class: S01HA03
VA Class: OP700
CAS Number: 136-47-0
Brands: Altacaine, Pontocaine, Tetcaine, Tetravisc

Introduction

Local anesthetic.^a ^b ^c

Uses for Tetracaine

Ophthalmic Anesthesia

Applied topically to the eye to produce local anesthesia for diagnostic and therapeutic procedures (e.g., tonometry, gonioscopy, removal of foreign bodies or sutures from the cornea, conjunctival and corneal scraping for diagnostic purposes, paracentesis of the anterior chamber, thorough examination and irrigation of painful injuries, short procedures involving the cornea and conjunctiva).^a ^b ^c

Rhinolaryngeal Anesthesia

Applied topically to produce anesthesia of the nose and throat.^a ^b

Used to abolish laryngeal and esophageal reflexes prior to diagnostic procedures (e.g., bronchoscopy, bronchography, esophagoscopy).^a ^b

Tetracaine Dosage and Administration

Administration

Apply topically to the eye as a 0.5% ophthalmic solution.^a ^b ^c Apply directly to larynx, trachea, or esophagus as a 0.25 or 0.5% topical solution, or administer via oral inhalation as a nebulized 0.5% solution.^a ^b

Do not use if solution contains crystals or is cloudy or discolored.^a ^b ^c

Ophthalmic Administration

Apply 0.5% ophthalmic solution topically to eye.^a ^c For topical anesthesia only;^b do not inject.^c Not for self-medication.^b

May add epinephrine 0.1% to produce vascular constriction when necessary.^b

Do not touch eyelids or surrounding area with dropper tip.^c

Do not touch or rub eye until the anesthetic effect has worn off.^c

Rhinolaryngeal Administration

Apply directly to larynx, trachea, or esophagus as a 0.25 or 0.5% topical solution, or administer via oral inhalation as a nebulized 0.5% solution.^a ^b

Commercially available 2% topical solution contains FD&C blue No. 1 to guard against accidental injection.^b

To avoid rapid absorption and high blood levels, do not administer in a coarse stream or by forceful injection.^b

Manufacturer recommends adding 0.06 mL epinephrine 0.1% to each mL of anesthetic solution to retard absorption.^b

Use care when measuring dose; measure dose accurately in every instance.^b (See Systemic Toxicity under Cautions.)

Dosage

Available as tetracaine hydrochloride; dosage expressed in terms of the salt.

Use the lowest dose resulting in effective anesthesia.^b (See Systemic Toxicity under Cautions.)

Adults

Ophthalmic Anesthesia

Ophthalmic Topical

Short-duration procedures: Instill 1–2 drops just prior to evaluation.^a ^b ^c

Minor surgical procedures: Instill 1–2 drops every 5–10 minutes for 1–3 doses.^c

Prolonged anesthesia: Instill 1–2 drops every 5–10 minutes for 3–5 doses.^c

Not for prolonged use.^b

Rhinolaryngeal Anesthesia

Rhinolaryngeal Topical

Administer as a 0.25 or 0.5% topical solution directly to larynx, trachea, or esophagus (total absorbed dose ≤20 mg).^a ^b

Oral Inhalation

Administer as a nebulized 0.5% solution (total absorbed dose ≤20 mg).^a ^b

Prescribing Limits

Adults

Rhinolaryngeal Anesthesia

Rhinolaryngeal Topical or Oral Inhalation

Maximum total absorbed dose: 20 mg (8 mL of a 0.25% solution or 4 mL of a 0.5% solution).^a ^b

Special Populations

Geriatric, Debilitated, or Acutely Ill Patients

Manufacturer recommends reduced doses commensurate with weight, age, and physical status; however, no specific dosage recommendations at this time.^b (See Systemic Toxicity under Cautions.)

Cautions for Tetracaine

Contraindications

Known hypersensitivity to tetracaine or other local anesthetics of the ester type, to p-aminobenzoic acid or its derivatives, or to any ingredient in the formulation.^a ^b ^c

Self-administration of ophthalmic solution by patients without clinician supervision.^c

Warnings/Precautions

Warnings

Systemic Toxicity

Rarely, use of local anesthetics causes reactions resulting in death.^b When a local anesthetic is used (e.g., tetracaine for rhinolaryngeal anesthesia), ensure immediate availability of resuscitative equipment and drugs.^b Excessive doses or rapid absorption may produce serious or fatal reactions.^b (See Administration and also Prescribing Limits under Dosage and Administration).

Systemic reactions following rhinolaryngeal administration may involve the CNS (e.g., excitation, depression, nervousness, dizziness, blurred vision, tremors, drowsiness, convulsions, unconsciousness, respiratory arrest) and cardiovascular system (e.g., myocardial depression, BP changes [typically hypotension], cardiac arrest).^b

Fatal reactions may occur even in the absence of a history of hypersensitivity.^b (See Hypersensitivity Reactions under Cautions.)

Following ophthalmic administration, systemic toxicity (mainly CNS stimulation followed by depression) occurs very rarely.^a

Use caution when administering to patients with abnormal or reduced levels of plasma esterases.^b

Prolonged Ophthalmic Use

Avoid prolonged use of ophthalmic solution.^a ^b ^c Corneal epithelial erosions, retardation or prevention of healing of corneal erosions, severe keratitis, and permanent corneal opacification and scarring with accompanying reduction of visual acuity or visual loss have occurred.^a ^b ^c

Ocular Effects

Protect anesthetized eye from irritating chemicals, foreign bodies, and rubbing to prevent corneal and conjunctival damage.^b ^c

Rarely, local idiosyncratic reactions (e.g., lacrimation, photophobia, chemosis) may occur.^a ^b

Serious Adverse Effects associated with Local Anesthetics

Risk of serious adverse effects (e.g., seizures, coma, irregular heart beat, respiratory depression) with use of topical local anesthetics; generally reported following application of extemporaneously prepared topical preparations containing high concentrations of anesthetics.^k

Potential for life-threatening adverse effects (e.g., irregular heart beat, seizures, breathing difficulties, coma, death) when topical local anesthetics are applied to a large area of skin, when the area of application is covered with an occlusive dressing, if a large amount of topical anesthetic is applied, if the anesthetic is applied to irritated or broken skin, or if the skin temperature increases (from exercise or use of a heating pad).¹⁰¹ ¹⁰²

Lidocaine 4% gel has been investigated to reduce discomfort during mammography.¹⁰¹ ¹⁰³ Whether such use could result in serious reactions has not been determined.¹⁰¹ ¹⁰³ Patients should speak with their clinician if they are considering using a topical anesthetic before obtaining a mammogram.¹⁰¹

When a topical anesthetic is needed for a procedure, use of an FDA-approved preparation has been recommended.^k Use a preparation containing the lowest concentration of anesthetic likely to be effective; apply a small amount of the preparation to the affected area for the shortest period necessary for the desired effect,^k and do not apply to broken or irritated skin.¹⁰¹

Sensitivity Reactions

Hypersensitivity Reactions

Following ophthalmic administration, rare, severe, immediate allergic corneal reaction reported (acute diffuse epithelial keratitis with filament formation and/or sloughing of large areas of necrotic epithelium, diffuse stromal edema, descemetitis, and iritis).^c Discontinue use if signs or symptoms of allergy or sensitivity occur.^a ^b

Following rhinolaryngeal administration, systemic allergic reactions may occur (e.g., cutaneous lesions [e.g., urticaria], edema, other allergic manifestations); possibly caused by hypersensitivity, idiosyncrasy, or diminished tolerance.^b Skin testing is of limited value in detecting sensitivity.^b

Rarely, severe allergic reactions, including anaphylaxis, have occurred following rhinolaryngeal administration; not typically dose related.^b

Specific Populations

Pregnancy

Category C.^b

Lactation

Not known whether tetracaine is distributed into milk.^b Use caution.^b

Pediatric Use

Safety and efficacy of ophthalmic and topical solutions not established.^a ^b

Common Adverse Effects

Ophthalmic topical: Stinging, burning, conjunctival redness.^c

Tetracaine Pharmacokinetics

Absorption

Onset

Ophthalmic solution: 25–30 seconds.^a ^c

Rhinolaryngeal topical solution: 5–10 minutes.^a ^b

Duration

Ophthalmic solution: ≥15 minutes.^a

Rhinolaryngeal topical solution: 30 minutes.^a ^b

Elimination

Metabolism

Systemically absorbed drug is detoxified in blood by plasma esterases.^b

Stability

Storage

Ophthalmic

Solution

Tight, light-resistant containers at 15–30°C; avoid freezing.^a ^c

Topical

Solution

Tight, light-resistant containers at 2–8°C.^a ^b

ActionsActions

Local anesthetic of the ester type, related to procaine.^a ^b ^c

Stabilizes neuronal membrane; prevents initiation and transmission of nerve impulses thereby effecting local anesthesia.^b ^c

Usually does not dilate the pupil, disturb accommodation, or increase intraocular pressure when applied to conjunctiva.^a ^b

Approximately equipotent to proparacaine hydrochloride.^a

Advice to Patients

Importance of not touching or rubbing eye(s) until anesthesia from ophthalmic solution has worn off.^a ^b ^c

Advise patient not to instill ophthalmic solution repeatedly; risk of severe eye damage.^b ^c

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

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

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

Preparations

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

* available from one or more manufacturer, distributor, and/or repackager by generic (nonproprietary) name

Tetracaine Hydrochloride
Routes	Dosage Forms	Strengths	Brand Names	Manufacturer
Ophthalmic	Solution*	0.5%*	Altacaine	Altaire
			Pontocaine Hydrochloride	Hospira
			Tetcaine	Ocusoft
			Tetracaine Hydrochloride Ophthalmic Solution
			Tetravisc	Ocusoft
Topical	Solution	2%	Pontocaine Hydrochloride	Hospira

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.

References

a. AHFS Drug Information 2008. McEvoy GK, ed. Tetracaine hydrochloride. Bethesda, MD: American Society of Health-System Pharmacists; 2008:2902-3.

b. Hospira, Inc. Pontocaine (tetracaine hydrochloride, USP) ophthalmology 0.5% solution and rhinolaryngology 2% solution prescribing information. Lake Forest, IL; 2004 Nov.

c. Bausch & Lomb Incorporated. Tetracaine hydrochloride ophthalmic solution USP, 0.5% prescribing information. Tampa, FL; 2004 Jan.

k. Food and Drug Administration. FDA Public Health Advisory: Life-threatening side effects with use of skin products containing numbing ingredients for cosmetic procedures. 2007 Feb 6, updated 2007 Feb 9. From FDA website ().

101. Food and Drug Administration. FDA Public Health Advisory: Potential hazards of skin products containing numbing ingredients for relieving pain from mammography and other medical tests and conditions. 2009 Jan 16. From FDA website ().

102. Food and Drug Administration. Topical Anesthetics. MedWatch alert. Rockville, MD; 2009 Jan 16. From FDA website (

103. Lambertz CK, Johnson CJ, Montgomery PG et al. Premedication to reduce discomfort during screening mammography. Radiology. 2008; 248:765-72. [PubMed 18647845]

More Tetracaine resources

Tetracaine Use in Pregnancy & Breastfeeding
Tetracaine Support Group
0 Reviews · Be the first to review/rate this drug

Tetracaine Drops MedFacts Consumer Leaflet (Wolters Kluwer)

Tetracaine Prescribing Information (FDA)

tetracaine Ophthalmic Advanced Consumer (Micromedex) - Includes Dosage Information

Saturday, 3 March 2012

magnesium oxide

Generic Name: magnesium oxide (mag NEE see um OCK side)

Brand names: Mag-200, Mag-Ox 400, MagGel, Uro-Mag, Phillips' Cramp-free

What is magnesium oxide?

Magnesium is a naturally occurring mineral. Magnesium is important for many systems in the body especially the muscles and nerves.

Magnesium oxide is used as a supplement to maintain adequate magnesium in the body.

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

What is the most important information I should know about magnesium oxide?

Before taking magnesium oxide, tell your doctor if you have any other medical conditions, allergies, or if you take other medicines or other herbal/health supplements. Magnesium oxide may not be recommended in some situations.

Who should not take magnesium oxide?

Do not take magnesium oxide without first talking to your doctor if you have kidney disease.

It is not known whether magnesium oxide will harm an unborn baby. Do not take magnesium oxide without first talking to your doctor if you are pregnant or planning a pregnancy. It is not known whether magnesium oxide will harm an nursing baby. Do not take magnesium oxide without first talking to your doctor if you are breast-feeding a baby.

How should I take magnesium oxide?

Take magnesium oxide exactly as directed by your doctor or as directed on the package. If you do not understand these directions, ask your pharmacist, nurse, or doctor to explain them to you.

Take the tablets and capsules with a full glass of water.

To ensure that you get the correct dose, measure the liquid form of magnesium with a dose-measuring spoon or cup, not with a regular table spoon. If you do not have a dose-measuring device, ask your pharmacist where you can get one.

Do not take more magnesium oxide than is directed. Store magnesium oxide at room temperature away from moisture and heat.

See also: Magnesium oxide dosage (in more detail)

What happens if I miss a dose?

Take the missed dose as soon as you remember. However, if it is almost time for the next dose, skip the dose you missed and take only the next regularly scheduled dose. Do not take a double dose of this medication.

What happens if I overdose?

Seek emergency medical attention.

Symptoms of an magnesium oxide overdose include nausea, vomiting, flushing, low blood pressure, a slow heartbeat, drowsiness, coma, and death.

What should I avoid while taking magnesium oxide?

There are no restrictions on food, beverages, or activity while taking magnesium oxide unless otherwise directed by your doctor.

Magnesium oxide side effects

Stop taking magnesium oxide and seek emergency medical attention if you experience an allergic reaction (difficulty breathing; closing of your throat; swelling of your lips, tongue, or face; or hives).

Other, less serious side effects may be more likely to occur. Continue to take magnesium oxide and talk to your doctor if you experience diarrhea or an upset stomach.

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.