Orajel Denture

Generic Name: benzocaine topical (BENZ oh kane TOP ik al)

Brand Names: Americaine, Americaine Hemorrhoidal, Anacaine, Anbesol Gel, Anbesol Liquid, Babee Teething Lotion, Benzo-O-Stetic, Boil Ease Pain Relieving, Cepacol Extra Strength, Cepacol Fizzlers, Dent-O-Kain, Dermoplast, Detane, Hurricaine, Lanacane, Maintain, Medicone Maximum Strength, Num-Zit, Numzident, Orabase, Orabase Gel-B, Orajel, Orajel Denture, Oral Pain Relief, OraMagic Plus, Outgro Pain Relief, Retre-Gel, Rid-A-Pain, Skeeter Stik, Solarcaine Aerosol, Sting-Kill, Topex, Trocaine, Vagisil Feminine Cream, zilactin-B

What is Orajel Denture (benzocaine topical)?

Benzocaine is a local anesthetic (numbing medication). It works by blocking nerve signals in your body.

Benzocaine topical is used to reduce pain or discomfort caused by minor skin irritations, sore throat, sunburn, teething pain, vaginal or rectal irritation, ingrown toenails, hemorrhoids, and many other sources of minor pain on a surface of the body. Benzocaine is also used to numb the skin or surfaces inside the mouth, nose, throat, vagina, or rectum to lessen the pain of inserting a medical instrument such as a tube or speculum.

There are many brands and forms of benzocaine topical available and not all brands are listed on this leaflet.

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

What is the most important information I should know about Orajel Denture (benzocaine topical)?

There are many brands and forms of benzocaine topical available and not all brands are listed on this leaflet.

Benzocaine topical used in the mouth or throat may cause a life-threatening condition in which the amount of oxygen in your blood stream becomes dangerously low. This condition is called methemoglobinemia (met-HEEM-oh glo-bin-EE-mee-a) and it may occur after only one use of benzocaine or after several uses.

Signs and symptoms of methemoglobinemia may occur within minutes or up to 2 hours after using benzocaine topical in the mouth or throat. GET EMERGENCY MEDICAL HELP IF YOU HAVE ANY OF THESE SYMPTOMS: headache, tired feeling, confusion, fast heart rate, and feeling light-headed or short of breath, with a pale, blue, or gray appearance of your skin, lips, or fingernails.

Do not use benzocaine topical if you have ever had methemoglobinemia in the past. Do not use this medicine on a child younger than 2 years old without medical advice. An overdose of numbing medications can cause fatal side effects if too much of the medicine is absorbed through your skin and into your blood. This is more likely to occur when using a numbing medicine without the advice of a medical doctor (such as during a cosmetic procedure like laser hair removal). Overdose symptoms may include uneven heartbeats, seizure (convulsions), coma, slowed breathing, or respiratory failure (breathing stops).

Use the smallest amount of this medication needed to numb the skin or relieve pain. Do not use large amounts of benzocaine topical, or cover treated skin areas with a bandage or plastic wrap without medical advice. Be aware that many cosmetic procedures are performed without a medical doctor present.

Your body may absorb more of this medication if you use too much, if you apply it over large skin areas, or if you apply heat, bandages, or plastic wrap to treated skin areas. Skin that is cut or irritated may also absorb more topical medication than healthy skin.

Before using benzocaine topical, tell your doctor if you have any type of inherited enzyme deficiency, heart disease, a breathing disorder such as asthma, bronchitis, or emphysema, or if you smoke.

If you are treating a sore throat, call your doctor if the pain is severe or lasts longer than 2 days, especially if you also develop a fever, headache, skin rash, swelling, nausea, vomiting, cough, or breathing problems.

What should I discuss with my health care provider before using Orajel Denture (benzocaine topical)?

Do not use benzocaine topical if you have ever had methemoglobinemia in the past. An overdose of numbing medications can cause fatal side effects if too much of the medicine is absorbed through your skin and into your blood. This is more likely to occur when using a numbing medicine without the advice of a medical doctor (such as during a cosmetic procedure like laser hair removal). Overdose symptoms may include uneven heartbeats, seizure (convulsions), coma, slowed breathing, or respiratory failure (breathing stops).

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

• 
  

  asthma, bronchitis, emphysema, or other breathing disorder;

  
  


• 
  

  heart disease;

  
  


• 
  

  a personal or family history of methemoglobinemia, or any genetic (inherited) enzyme deficiency; or

  
  


• 
  

  if you smoke.

  
  

FDA pregnancy category C. It is not known whether benzocaine topical will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant while using this medication.. It is not known whether benzocaine topical passes into breast milk or if it could harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby. Do not use this medicine on a child younger than 2 years old without medical advice.

How should I use Orajel Denture (benzocaine topical)?

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.

Your body may absorb more of this medication if you use too much, if you apply it over large skin areas, or if you apply heat, bandages, or plastic wrap to treated skin areas. Skin that is cut or irritated may also absorb more topical medication than healthy skin.

Use the smallest amount of medicine needed to numb the skin or relieve pain. Do not use large amounts of benzocaine topical, or cover treated skin areas with a bandage or plastic wrap without medical advice. Be aware that many cosmetic procedures are performed without a medical doctor present.

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

To treat minor skin conditions, apply a thin layer of benzocaine topical to the affected area up to 4 times per day. If using the spray, hold the container 6 to 12 inches away from the skin. Do not spray this medication onto your face. Spray it instead on your hands and then rub it onto the face, avoiding contact with your eyes.

To treat hemorrhoids, clean the area with soap and water before applying benzocaine topical. Apply the medication up to 6 times per day. If you are using the rectal suppository, try to empty your bowel and bladder before inserting the suppository. Remove the outer wrapper from the suppository before inserting it. Avoid handling the suppository too long or it will melt in your hands.

Do not use benzocaine topical to treat large skin areas or deep puncture wounds. Avoid using the medicine on skin that is raw or blistered, such as a severe burn or abrasion.

Call your doctor if your symptoms do not improve or if they get worse within the first 7 days of using benzocaine topical. Also call your doctor if your symptoms had cleared up but then came back.

If you are treating a sore throat, call your doctor if the pain is severe or lasts longer than 2 days, especially if you also develop a fever, headache, skin rash, swelling, nausea, vomiting, cough, or breathing problems.

Store at room temperature away from moisture and heat. Do not freeze.

What happens if I miss a dose?

Since benzocaine topical is used as needed, you may not be on a dosing schedule. If you are using the medication regularly, use the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not use 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. An overdose of benzocaine topical applied to the skin can cause life-threatening side effects such as uneven heartbeats, seizure (convulsions), coma, slowed breathing, or respiratory failure (breathing stops).

What should I avoid while taking Orajel Denture (benzocaine topical)?

Avoid eating within 1 hour after using benzocaine topical on your gums or inside your mouth.

Benzocaine topical is for use only on the surface of your body, or just inside the mouth, vagina, or rectum. Avoid getting this medication in your eyes. Avoid swallowing the gel, liquid, or ointment while applying it to your gums or the inside of your mouth. The throat spray or oral lozenge may be swallowed gradually during use.

Do not apply other medications to the same affected areas you treat with benzocaine topical, unless your doctor has told you otherwise.

Orajel Denture (benzocaine topical) side effects

Benzocaine topical used in the mouth or throat may cause a life-threatening condition in which the amount of oxygen in your blood stream becomes dangerously low. This condition is called methemoglobinemia (met-HEEM-oh glo-bin-EE-mee-a) and it may occur after only one use of benzocaine or after several uses.

Signs and symptoms may occur within minutes or up to 2 hours after using benzocaine topical in the mouth or throat. GET EMERGENCY MEDICAL HELP IF YOU HAVE:

• 
  

  headache, tired feeling, confusion;

  
  


• 
  

  fast heart rate;

  
  


• 
  

  feeling light-headed or short of breath; and

  
  


• 
  

  pale, blue, or gray appearance of your skin, lips, or fingernails.

  
  

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 benzocaine topical and call your doctor at once if you have any of these other serious side effects:

• 
  

  headache, weakness, dizziness, breathing problems, fast heart rate, and gray or bluish colored skin (rare but serious side effects of benzocaine);

  
  


• 
  

  severe burning, stinging, or sensitivity where the medicine is applied;

  
  


• 
  

  swelling, warmth, or redness; or

  
  


• 
  

  oozing, blistering, or any signs of infection.

  
  

Less serious side effects may include:

• 
  

  mild stinging, burning, or itching where the medicine is applied;

  
  


• 
  

  skin tenderness or redness; or

  
  


• 
  

  dry white flakes where the medicine was applied.

  
  

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 Orajel Denture (benzocaine topical)?

It is not likely that other drugs you take orally or inject will have an effect on topically applied benzocaine topical. But many drugs can interact with each other. 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.

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Compare Orajel Denture with other medications

• Oral and Dental Conditions

Where can I get more information?

• Your pharmacist can provide more information about benzocaine topical.

See also: Orajel Denture side effects (in more detail)

Tetanus Immune Globulin

Class: Serums
ATC Class: J07AM52
VA Class: IM500
Brands: HyperTET S/D

Introduction

Specific immune globulin (hyperimmune globulin).^{104 106} Tetanus immune globulin (TIG) contains tetanus antitoxin and is used to provide temporary passive immunity to tetanus.^{104 106 110 111} TIG commercially available in the US is prepared from plasma of donors immunized with tetanus toxoid.¹⁰⁴ Other tetanus antitoxin preparations (e.g., equine tetanus antitoxin) may be available in other countries.¹⁰¹

Uses for Tetanus Immune Globulin

Postexposure Prophylaxis of Tetanus

Postexposure prophylaxis of tetanus in individuals with tetanus-prone wounds who have previously received <3 doses of a preparation containing tetanus toxoid adsorbed or whose tetanus vaccination status is uncertain.^{100 101 103 104 110 112 113 115}

TIG provides temporary passive immunity against tetanus.^{100 104 110} It is not a substitute for active immunization with a preparation containing tetanus toxoid adsorbed and is not a substitute for adequate medical and surgical care of contaminated or potentially contaminated wounds.^{100 101} (See General under Dosage and Administration.)

Tetanus is a potentially fatal disease caused by a neurotoxic exotoxin produced by Clostridium tetani (tetanospasmin).^{101 110 111} C. tetani spores are ubiquitous in the environment and are found in soil and in animal (e.g., horses, sheep, cattle, dogs, cats, rats, guinea pigs, chickens) and human intestinal tracts.^{100 101 110 111} The spores can contaminate open wounds, especially puncture wounds or those with devitalized tissue; anaerobic wound conditions allow the spores to germinate and produce exotoxins that disseminate through the blood and lymphatic system.^{101 110} Neonatal tetanus occurs in infants born under nonsterile conditions to women inadequately vaccinated against tetanus; infection usually involves a contaminated umbilical stump and occurs because infant does not have passively acquired maternal antibodies against tetanus.^{100 101 110 111 115} Obstetric tetanus occurs within 6 weeks after delivery or termination of pregnancy because of contaminated wounds or abrasions or unclean deliveries or abortions.¹¹⁵ Generalized tetanus is characterized by rigidity and convulsive muscle spasms that usually involve the jaw (lockjaw) and neck and then become generalized.^{101 110 111} Tetanus occurs worldwide, almost exclusively in individuals who are unvaccinated or inadequately vaccinated against the disease.^{101 111} An average of 31 cases reported each year in the US from 2000 through 2007 (case fatality rate 10%);¹¹⁰ 20 cases reported in 2003.¹¹⁰ Most cases of tetanus in the US occur following acute injuries or wounds (puncture wounds, lacerations, abrasions) and usually occur in adults ≥40 years of age; however, an increase in the disease has been reported in younger adults (e.g., heroin abusers).^{110 116}

Tetanus-prone wounds include wounds contaminated with dirt, feces, soil, or saliva; puncture wounds; avulsions; and wounds resulting from crushing, burns, or frostbite.^{100 101 103 110 111} Tetanus also has been associated with apparently clean, superficial wounds, surgical procedures, insect bites, animal bites, dental infections, chronic sores and infections, and IV drug abuse.^{110 111} Tetanus is not transmitted person-to-person.^{110 111}

TIG is not necessary for tetanus postexposure prophylaxis in patients with clean, minor wounds (regardless of their immunization status) or for patients with tetanus-prone wounds who have previously received ≥3 doses of a preparation containing tetanus toxoid adsorbed.^{100 101 103}

In the event of injury and possible exposure to tetanus, the need for active immunization against tetanus with or without passive immunization with TIG depends on the individual’s vaccination status and the likelihood of contamination with tetanus bacilli (e.g., condition of wound, source of contamination).^{100 101 110 112 113 115} See Table 1 for ACIP guidelines regarding tetanus postexposure prophylaxis.^{100 112 113}

Tetanus toxoid, reduced diphtheria toxoid and acellular pertussis vaccine adsorbed (Tdap). A dose of Tdap is preferred to a dose of Td in adolescents and adults 11 through 64 years of age who have not previously received a dose of Tdap. Use Td in individuals in this age group who previously received a dose of Tdap.

Tetanus and diphtheria toxoids adsorbed (Td). Td is used in adults, adolescents, and children ≥7 years of age. For children 6 weeks through 6 years of age, DTaP usually is indicated, but DT can be used if pertussis antigens are contraindicated. Monovalent tetanus toxoid adsorbed generally is used only when preparations containing tetanus and diphtheria antigens and preparations containing tetanus, diphtheria, and pertussis antigens are contraindicated or unavailable.

If only 3 doses of tetanus toxoid fluid (no longer commercially available in the US) have been received previously, a fourth dose should be given as a preparation containing tetanus toxoid adsorbed.

Yes, if it has been >10 years since last dose of tetanus toxoid-containing preparation.

Yes, if it has been >5 years since last dose of tetanus toxoid-containing preparation; more frequent booster doses not needed and can accentuate adverse effects.

Adapted from the Recommendations of the Immunization Practices Advisory Committee (ACIP) on prevention of diphtheria, tetanus, and pertussis published in MMWR Recomm Rep. 1991; 40(RR-10):1-28, MMWR Recomm Rep. 2006; 55(RR-3):1-43, and MMWR Recomm Rep. 2006; 55(RR-17):1-37.

Table 1. Summary Guide to Tetanus Prophylaxis in Routine Wound Management100112113

	Clean, Minor Wounds	All Other Wounds
Previous Doses of Tetanus Toxoid Adsorbed Received	Tdap or Td	TIG	Tdap or Td	TIG
Unknown or <3	Yes	No	Yes	Yes
≥3	No	No	No	No

Any individual whose tetanus vaccination status is unknown or uncertain should be considered to have had no previous doses of tetanus toxoid adsorbed.^{100 104 112 113 115}

Anti-infectives are not indicated for tetanus postexposure prophylaxis.^{100 110}

Treatment of Tetanus

Treatment of tetanus.^{101 104 110 111 115} Used in conjunction with an anti-infective active against C. tetani (e.g., metronidazole, penicillin G) and with sedatives and muscle relaxants as needed.^{101 111 115}

Treatment of neonatal tetanus in conjunction with an anti-infective active against C. tetani (e.g., penicillin G).^{108 109}

Evidence of effectiveness of TIG in the treatment of active tetanus infection is limited and optimum dosage not established.^{101 104} Although TIG can neutralize unbound exotoxin, it does not affect toxin already bound to nerve endings.¹¹⁰

Recovery from tetanus does not result in naturally-acquired tetanus immunity.^{100 104 110 111} As soon as possible, initiate or complete active immunization against tetanus using a preparation containing tetanus toxoid adsorbed.^{100 104 110 111}

Tetanus Immune Globulin Dosage and Administration

General

• 
  

  Wound care is an essential part of postexposure prophylaxis or treatment of tetanus.^{100 101 104 110 111} Wound care is necessary regardless of vaccination status.^{100 101 104 110} Clean and debride wounds properly, especially if dirt or necrotic tissue is present; remove all necrotic tissue and foreign material.^{101 110}

  
  


• 
  

  For treatment of tetanus, an anti-infective active against C. tetani (e.g., metronidazole or penicillin G given for 10–14 days) may be indicated in addition to TIG.¹⁰¹ Control tetanic muscle spasms as indicated.^{101 111} (See Treatment of Tetanus under Uses.)

  
  

Administration

IM Administration

Administer by deep IM injection.¹⁰⁴

Do not administer IV^{101 104} or intrathecally.¹⁰¹ (See Administration Precautions under Cautions.)

Some clinicians recommend that part of the TIG dose be infiltrated locally around wound;^{101 110} efficacy of this approach not proven.¹⁰¹

IM injections of TIG preferably should be made into the anterolateral aspect of the thigh or deltoid muscle.¹⁰⁴ Because of the risk of injury to the sciatic nerve, the gluteal muscle should not be used as an injection site.¹⁰⁴

Although the manufacturer recommends that aspiration (i.e., pulling back on the syringe plunger after needle insertion and before injection) be performed to ensure that a blood vessel has not been entered,¹⁰⁴ ACIP and AAP state this procedure is not required because large blood vessels are not present at recommended IM injection sites.^{101 106}

Do not administer TIG in the same syringe or at the same injection site as tetanus toxoid adsorbed.^{100 101 104 106 115} (See Specific Drugs under Interactions.)

Do not mix with other immune globulins, vaccines, or solutions.^{101 104}

Dosage

Pediatric Patients

Postexposure Prophylaxis of Tetanus

Children <7 Years of Age†

IM

Single dose of 4 units/kg.¹⁰⁴ Consider using adult dosage (single dose of 250 units) regardless of child’s size since theoretically the amount of toxin produced by C. tetani in a child’s body would be the same as that produced in an adult’s body.¹⁰⁴

Children ≥7 Years of Age†

IM

Single dose of 250 units.¹⁰⁴

Treatment of Tetanus

Children†

IM

3000–6000 units usually recommended.^{101 110} Optimum dosage not established;^{101 104} adjust dosage according to severity of infection.¹⁰⁴

Some clinicians suggest that a portion of the TIG dose be infiltrated locally around the wound,^{101 110} although efficacy of this approach has not been established.¹⁰¹

Neonatal Tetanus†

IM

500 units has been administered in conjunction with anti-infective therapy (e.g., 10-day regimen of penicillin G).^{108 109}

Adults

Postexposure Prophylaxis of Tetanus

IM

Single dose of 250 units.^{100 101 104}

Treatment of Tetanus

IM

3000–6000 units usually recommended.^{101 110} Optimum dosage not established;^{101 104} adjust dosage according to severity of infection.¹⁰⁴

Some clinicians suggest that a portion of the TIG dose be infiltrated locally around the wound,^{101 110} although efficacy of this approach has not been established.¹⁰¹

Special Populations

Hepatic Impairment

No specific dosage recommendations.

Renal Impairment

No specific dosage recommendations.

Geriatric Patients

No specific dosage recommendations.

Cautions for Tetanus Immune Globulin

Contraindications

• 
  

  Manufacturer states none known.¹⁰⁴

  
  

Warnings/Precautions

Warnings

Risk of Transmissible Agents in Plasma-derived Preparations

Because TIG is prepared from pooled human plasma, it may carry a risk of transmitting infectious agents, including the causative agents of viral hepatitis and HIV infection, and theoretically may carry a risk of transmitting the causative agent of Creutzfeldt-Jakob disease (CJD) or variant CJD (vCJD).^{104 107}

Improved donor screening, viral-inactivation procedures (e.g., solvent/detergent treatment), and/or filtration procedures have reduced, but not completely eliminated, risk of pathogen transmission with plasma-derived preparations.¹⁰⁴

The manufacturing process for TIG includes certain chemical (solvent/detergent) treatment procedures and/or heat-treatment procedures to reduce viral infectious potential.¹⁰⁴

Because no purification method has been shown to be totally effective in removing the risk of viral infectivity from plasma-derived preparations and because new blood-borne viruses or other disease agents may emerge which may not be inactivated by the manufacturing process or the chemical (solvent/detergent) treatment procedures currently used, administer TIG only when a benefit is expected.¹⁰⁴

Any infection believed to have been transmitted by TIG should be reported to the manufacturer at 800-520-2807.¹⁰⁴

Sensitivity Reactions

Hypersensitivity Reactions

Sensitization to repeated injections of human immune globulin occurs rarely.¹⁰⁴

Angioedema, nephrotic syndrome, and anaphylactic shock reported rarely.¹⁰⁴

Use caution in individuals who have exhibited previous systemic allergic reactions to immune globulin.¹⁰⁴

Skin testing (i.e., intradermal injection of concentrated IgG solutions) is unreliable since localized areas of inflammation may occur as the result of localized tissue irritation and can be misinterpreted as a positive allergy reaction.¹⁰⁴

Epinephrine and other appropriate agents should be readily available in case anaphylaxis or other serious allergic reaction occurs.¹⁰⁴

General Precautions

Individuals with Altered Immunocompetence

Recommendations regarding use of TIG in individuals with altered immunocompetence are the same as those for individuals who are not immunocompromised.¹⁰⁵

ACIP states that recommendations concerning use of TIG in patients with altered immunocompetence, including HIV-infected individuals or those severely immunocompromised because of congenital immunodeficiency, leukemia, lymphoma, aplastic anemia, generalized malignancy, or therapy with alkylating agents, antimetabolites, radiation, or corticosteroids, are the same as those for patients who are not immunocompromised.¹⁰⁵

AAP states that TIG should be used in the management of tetanus prone wounds in all HIV-infected individuals, regardless of their tetanus immunization history.¹⁰¹

Administration Precautions

Do not administer TIG in the same syringe or at the same injection site as tetanus toxoid adsorbed.^{100 101 104 106} (See Specific Drugs under Interactions.)

Avoid inadvertent IV administration of TIG; serious systemic reactions (e.g., precipitous decrease in BP, anaphylaxis-like reaction) have occurred following inadvertent IV administration of immune globulin intended for IM administration.¹⁰⁴

Individuals with Bleeding Disorders

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 in such individuals only if benefits outweigh risks.^{104 106}

ACIP states that IM injections can be used in individuals who have bleeding disorders or are receiving anticoagulant therapy if a clinician familiar with the patient's bleeding risk determines that the injection can be administered with reasonable safety.¹⁰⁶ In these cases, use a fine needle (23 gauge) to administer the dose and apply firm pressure to the injection site (without rubbing) for ≥2 minutes.¹⁰⁶ If patient is receiving antihemophilia therapy, administer the IM dose shortly after a scheduled dose of such therapy.¹⁰⁶

Advise individual and/or their family about the risk of hematoma from IM injections.¹⁰⁶

Duration of Immunity

TIG provides only short-term protection against tetanus.^{104 110}

As soon as possible, initiate or complete active immunization against tetanus using a preparation containing tetanus toxoid adsorbed.^{100 110}

Specific Populations

Pregnancy

Category C.¹⁰⁴

Use during pregnancy only when clearly needed.¹⁰⁴

ACIP states that pregnancy is not generally considered a contraindication to use of TIG for treatment or postexposure prophylaxis of tetanus.^{103 115}

Pediatric Use

Safety and efficacy not established in children.¹⁰⁴

AAP recommends that postexposure prophylaxis (including use of TIG) in children follow the same guidelines as those in adults.¹⁰¹

Geriatric Use

Information not available regarding differences in efficacy and safety between geriatric and younger individuals.

Common Adverse Effects

Slight soreness at site of injection, low-grade fever.¹⁰⁴

Interactions for Tetanus Immune Globulin

Inactivated Vaccines and Toxoids

Immune globulins, including TIG, are not expected to have a clinically important effect on the immune response to inactivated vaccines or toxoids; inactivated vaccines, recombinant vaccines, polysaccharide vaccines, and toxoids may be administered simultaneously with (using different syringes and different injection sites) or at any interval before or after administration of TIG.¹⁰⁶

Live Vaccines

Antibodies present in immune globulins, including TIG, may interfere with the immune response to certain live virus vaccines (e.g., measles, mumps, and rubella virus vaccine live [MMR], rotavirus vaccine live oral, varicella virus vaccine live).^{101 104 106} (See Specific Drugs under Interactions.) There is no evidence that immune globulin preparations interfere with the immune response to yellow fever virus vaccine live, typhoid vaccine live oral, influenza virus vaccine live intranasal, or poliovirus vaccine live oral (OPV; no longer commercially available in the US).¹⁰⁶

Specific Drugs

Drug	Interaction	Comments
Influenza vaccine	Intranasal live influenza vaccine: No evidence that immune globulin preparations interfere with the immune response to the vaccine106 Parenteral inactivated influenza vaccine: Interference with the immune response to this inactivated vaccine is not expected106	Intranasal live influenza vaccine or parenteral inactivated influenza vaccine may be given simultaneously with or at any interval before or after TIG106
Measles, mumps, and rubella vaccine (MMR)	Immune globulin preparations, including TIG, may interfere with the immune response to measles and rubella antigens contained in MMR; the effect of TIG on the immune response to mumps antigen in the vaccine is unknown106	MMR should not be administered simultaneously with or within 3 months before or after TIG104 106 If TIG is administered <14 days after MMR, revaccination is necessary at least 3 months after the TIG dose, unless serologic testing indicates that there was an adequate antibody response to all 3 antigens contained in MMR106
Rotavirus vaccine	TIG may interfere with the immune response to rotavirus vaccine106 Safety and efficacy data not available regarding use of rotavirus vaccine in infants who have received an immune globulin within 42 days114	Rotavirus vaccine may be administered simultaneously with or at any time before or after blood or antibody-containing preparations117 118
Tetanus toxoid adsorbed		Active immunization against tetanus should be initiated at the same time as passive immunization with TIG; however, TIG and preparations containing tetanus toxoid adsorbed should be given at separate sites using different syringes101 104 112 113 115
Typhoid vaccine	Oral live typhoid vaccine (Vivotif): No evidence that immune globulin preparations interfere with the immune response to the vaccine106 Parenteral inactivated typhoid vaccine (Typhim Vi): Specific studies evaluating concomitant use with immune globulins not available; interaction not expected since this is an inactivated vaccine106	Oral live typhoid vaccine (Vivotif): May be given simultaneously with or at any time before or after TIG106 Parenteral inactivated vaccines may be given simultaneously with TIG (using different syringes and injection sites) or at any time before or after TIG106
Varicella vaccine	Immune globulin preparations, including TIG, may interfere with the immune response to varicella vaccine live106	Varicella vaccine live should not be administered simultaneously with or within 3 months before or after TIG106 If TIG is administered <14 days after varicella vaccine live, revaccination is necessary at least 3 months after the TIG dose, unless serologic testing indicates that there was an adequate antibody response to the vaccine106
Yellow fever vaccine	No evidence that immune globulin preparations interfere with the immune response to yellow fever virus vaccine live106	Yellow fever vaccine may be given simultaneously with TIG (using different syringes and injection sites) or at any time before or after TIG106

Tetanus Immune Globulin Pharmacokinetics

Elimination

Half-life

Approximately 28 days.^a

Stability

Storage

Parenteral

Injection, for IM Use

2–8°C.¹⁰⁴ Do not freeze; if freezing occurs, discard TIG.¹⁰⁴

Does not contain thimerosal or any other preservatives.¹⁰⁴

ActionsActions

• 
  

  TIG is a sterile, concentrated, nonpyrogenic solution of immunoglobulins prepared by cold alcohol fractionation from plasma of adults immunized with tetanus toxoid.¹⁰⁴

  
  


• 
  

  TIG contains 15–18% protein.¹⁰⁴ It is standardized against US Standard Antitoxin and US Control Tetanus Toxin to contain ≥250 tetanus antitoxin units per dose.¹⁰⁴

  
  


• 
  

  Used to provide temporary passive immunity to tetanus.^{100 101 104 110 112 113 115}

  
  


• 
  

  Tetanus antitoxin antibodies in TIG neutralize exotoxin produced by C. tetani, the causative organism of tetanus.^{104 115} TIG can only neutralize unbound exotoxin, it does not affect toxin already bound to nerve endings.¹¹⁰

  
  


• 
  

  Tetanus incubation period is usually 8–10 days (range 3–21 days) following infection of a wound.^{101 110 111} Symptoms of neonatal tetanus usually occur during the first 2 weeks of life.^{101 110}

  
  

Advice to Patients

• 
  

  Advise patient and/or patient's parent or guardian of the risks and benefits of TIG.¹⁰⁴

  
  


• 
  

  Advise patient and/or patient's parent or guardian that TIG is only one component of a postexposure regimen used to prevent tetanus in unvaccinated or incompletely vaccinated individuals with a tetanus-prone wound.¹⁰⁴ Importance of completing active immunization with a preparation containing tetanus toxoid adsorbed as soon as possible.^{101 104 110}

  
  


• 
  

  Importance of informing clinicians if any adverse reactions (e.g., hypersensitivity reactions) occur.¹⁰⁴

  
  


• 
  

  Advise patient and/or patient's parent or guardian that HyperTET S/D is prepared from pooled human plasma.¹⁰⁴ Although improved donor screening and viral-inactivating and purification procedures used in manufacture of plasma-derived preparations have reduced the risk of pathogen transmission, TIG is a potential vehicle for transmission of human viruses, including the causative agents of viral hepatitis and HIV infection, and theoretically may carry a risk of transmitting the causative agent of CJD or vCJD.¹⁰⁴

  
  


• 
  

  Importance of informing clinicians of existing or contemplated concomitant therapy, including prescription and OTC drugs, and any concomitant illnesses.¹⁰⁴

  
  


• 
  

  Importance of women informing clinicians if they are or plan to become pregnant or plan to breastfeed.¹⁰⁴

  
  


• 
  

  Importance of informing patients of other important precautionary information. (See Cautions.) ¹⁰⁴

  
  

Preparations

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

Tetanus Immune Globulin

Routes	Dosage Forms	Strengths	Brand Names	Manufacturer
Parenteral	Injection, for IM use	≥250 units	HyperTET S/D (solvent/detergent treated)	Talecris

Disclaimer

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

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

AHFS Drug Information. © Copyright, 1959-2011, Selected Revisions September 2010. American Society of Health-System Pharmacists, Inc., 7272 Wisconsin Avenue, Bethesda, Maryland 20814.

† Use is not currently included in the labeling approved by the US Food and Drug Administration.

References

Only references cited for selected revisions after 1984 are available electronically.

100. Centers for Disease Control. Diphtheria, tetanus, and pertussis: recommendations for vaccine use and other preventive measures: Recommendations of the Immunization Practices Advisory Committee (ACIP). MMWR Recomm Rep. 1991; 40(RR-10):1-28.

101. American Academy of Pediatrics. Red Book: 2009 Report of the Committee on Infectious Diseases. 28th ed. Elk Grove Village, IL: American Academy of Pediatrics; 2009.

102. Abrutyn E, Berlin JA. Intrathecal therapy in tetanus: a meta-analysis. JAMA. 1991;266:2262-7.

103. Centers for Disease Control. Update on adult immunization: recommendations of the Immunization Practices Advisory Committee (ACIP). MMWR Recomm Rep. 1991; 40(RR-12):18,49,70,87. [PubMed 1956371]

104. Talecris Biotherapeutics. HyperTET S/D (tetanus immune globulin [human]) solvent/detergent treated prescribing information. Research Triangle Park, NC; 2008 May.

105. Centers for Disease Control and Prevention. Recommendations of the Advisory Committee on Immunization Practices (ACIP): use of vaccines and immune globulins in persons with altered immunocompetence. MMWR Recomm Rep. 1993; 42(RR-4):1-18.

106. Centers for Disease Control and Prevention. General recommendations on immunization: recommendations of the Advisory Committee on Immunization Practices (ACIP). MMWR Recomm Rep. 2006; 55(RR-15):1-48.

107. US Department of Health and Human Services, Food and Drug Administration, Center for Biologics Evaluation and Research (CBER). Guidance for industry. Revised preventive measures to reduce the possible risk of transmission of Creutzfeldt-Jakob disease (CJD) and variant Creutzfeldt-Jakob disease (vCJD) by blood and blood products. May 2010. From FDA website.

108. Craig AS, Reed GW, Mohon RT et al. Neonatal tetanus in the United States: a sentinel event in the foreign-born. Pediatr Infect Dis J. 1997; 16:955-9. [PubMed 9380471]

109. Centers for Disease Control and Prevention. Neonatal tetanus—Montana, 1998. MMWR Morb Mortal Wkly Rep. 1998; 47:928-30. [IDIS 414319] [PubMed 9822366]

110. Centers for Disease Control and Prevention. Epidemiology and prevention of vaccine-preventable diseases. 11th ed. Washington, DC: Public Health Foundation; 2009.

111. Centers for Disease Control and Prevention. Health information for international travel, 2010. Atlanta, GA: US Department of Health and Human Services; 2010. Updates available from CDC website.

112. Kretsinger K, Broder KR, Cortese MM et al. Preventing tetanus, diphtheria, and pertussis among adults: use of tetanus toxoid, reduced diphtheria toxoid and acellular pertussis vaccine recommendations of the Advisory Committee on Immunization Practices (ACIP) and recommendation of ACIP, supported by the Healthcare Infection Control Practices Advisory Committee (HICPAC), for use of Tdap among health-care personnel. MMWR Recomm Rep. 2006; 55:1-37.

113. Broder KR, Cortese MM, Iskander JK et al. Preventing tetanus, diphtheria, and pertussis among adolescents: use of tetanus toxoid, reduced diphtheria toxoid and acellular pertussis vaccines recommendations of the Advisory Committee on Immunization Practices (ACIP). MMWR Recomm Rep. 2006; 55:1-34.

114. Merck & Co. RotaTeq (rotavirus vaccine, live, oral, pentavalent) prescribing information. Whitehouse Station, NJ; 2009 Dec.

115. Murphy TV, Slade BA, Broder KR et al. Prevention of pertussis, tetanus, and diphtheria among pregnant and postpartum women and their infants recommendations of the Advisory Committee on Immunization Practices (ACIP). MMWR Recomm Rep. 2008; 57:1-51. [PubMed 18509304]

116. Pascual FB, McGinley EL, Zanardi LR et al. Tetanus surveillance--United States, 1998--2000. MMWR Surveill Summ. 2003; 52:1-8. [PubMed 12825541]

117. Cortese MM, Parashar UD, Centers for Disease Control and Prevention (CDC). Prevention of rotavirus gastroenteritis among infants and children: recommendations of the Advisory Committee on Immunization Practices (ACIP). MMWR Recomm Rep. 2009; 58:1-25.

118. Committee on Infectious Diseases, American Academy of Pediatrics. Prevention of rotavirus disease: updated guidelines for use of rotavirus vaccine. Pediatrics. 2009; 123:1412-20. [PubMed 19332437]

a. AHFS drug information 2010. McEvoy GK, ed. Tetanus immune globulin. Bethesda, MD: American Society of Health-System Pharmacists; 2010:3343-5.

More Tetanus Immune Globulin resources

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

• tetanus immune globulin Intramuscular Advanced Consumer (Micromedex) - Includes Dosage Information


• Hypertet S/D Prescribing Information (FDA)

Compare Tetanus Immune Globulin with other medications

• Tetanus
• Tetanus Prophylaxis

Trazo

Trazo may be available in the countries listed below.

Ingredient matches for Trazo

Trazodone

Trazodone hydrochloride (a derivative of Trazodone) is reported as an ingredient of Trazo in the following countries:

• Taiwan

International Drug Name Search

OraMagic Plus

Generic Name: benzocaine (Oral route, Oromucosal route)

BEN-zoe-kane

Commonly used brand name(s)

In the U.S.

• Anbesol


• Babee Teething


• Benzodent


• Benz-O-Sthetic


• Bi-Zets/Benzo-Troches


• Dentemp's


• Dent-O-Kain/20


• Detane


• Gumsol


• HAD


• Hurricaine


• Hurricane Spray Kit


• Kank-A Soft Brush


• Larynex


• Miradyne-3


• Mycinette


• Orabase-B


• Oracaine


• Ora film


• Orajel


• OraMagic Plus


• Orasol


• Red Cross Canker Sore


• Thorets


• Trocaine


• Zetts


• Zilactin


• Zilactin-B

In Canada

• Anbesol Extra Strength


• Anbesol Liquid


• Baby Anbesol


• Baby Orajel


• Baby Orajel Liquid


• Maximum Strength Orajel Pm


• Orajel Extra Strength

Available Dosage Forms:

• Liquid


• Gel/Jelly


• Solution


• Lozenge/Troche


• Film


• Lotion


• Ointment


• Powder for Suspension


• Cream


• Tablet, Disintegrating


• Swab


• Spray


• Gum


• Paste

Therapeutic Class: Anesthetic, Local

Chemical Class: Amino Ester

Uses For OraMagic Plus

Benzocaine lozenges are used to relieve pain and irritation caused by sore throat, sore mouth, or canker sores.

This medicine is available without a prescription; however, your doctor may have special instructions on the proper use and dose for your medical problem.

Before Using OraMagic Plus

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

No information is available on the relationship of age to the effects of benzocaine lozenges in the pediatric population. Safety and efficacy have not been established in children below 5 years of age.

Geriatric

No information is available on the relationship of age to the effects of benzocaine in geriatric patients.

Interactions with Medicines

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

Interactions with Food/Tobacco/Alcohol

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

Other Medical Problems

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

• Infection in or around your mouth or


• Large sores in or around your mouth—The chance of side effects may be increased.

Proper Use of benzocaine

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

Use this medicine exactly as directed by your doctor. Do not use more of this medicine, do not use it more often, and do not use it for a longer time than directed. To do so may increase the chance of absorption into the body and the risk of side effects.

This medicine should be used only for problems being treated by your doctor or conditions listed in the package directions. Check with your doctor before using it for other problems, especially if you think that an infection may be present.

Do not use this medicine for more than 2 days without checking first with your doctor.

Dosing

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

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

• For oral dosage form (lozenges):
  
  • For sore throat and mouth pain:
    
    • Adults, teenagers, and children 5 years of age and older—One lozenge, dissolved slowly in the mouth every 2 hours as needed.
    
    
    • Children younger than 5 years of age—Use is not recommended.
    
    
  
  

Missed Dose

If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Precautions While Using OraMagic Plus

If your condition does not improve within 7 days, or if it becomes worse, check with your doctor.

Call your doctor right away if you start to have a severe sore throat or sore throat that occurs with a high fever, headache, nausea, or vomiting. These maybe signs of an infection.

OraMagic Plus Side Effects

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

Incidence not known

• Headache


• high fever


• nausea


• vomiting


• worsening of pain, redness, swelling, or irritation in or around the mouth

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: OraMagic Plus 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 OraMagic Plus resources

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

• OraMagic Plus Suspension MedFacts Consumer Leaflet (Wolters Kluwer)


• OraMagic Plus Concise Consumer Information (Cerner Multum)


• Americaine Ointment MedFacts Consumer Leaflet (Wolters Kluwer)


• Benz-O-Sthetic Gel MedFacts Consumer Leaflet (Wolters Kluwer)


• Lanacane Aerosol Spray MedFacts Consumer Leaflet (Wolters Kluwer)

Compare OraMagic Plus with other medications

• Oral and Dental Conditions

OraVerse

Generic Name: phentolamine (Injection route)

fen-TOL-a-meen

Commonly used brand name(s)

In the U.S.

• OraVerse


• Regitine

Available Dosage Forms:

• Solution


• Injectable


• Powder for Solution

Therapeutic Class: Antihypertensive

Pharmacologic Class: Alpha-Adrenergic Blocker

Uses For OraVerse

Phentolamine given by injection causes blood vessels to expand, thereby increasing blood flow. When injected into the penis (intracavernosal), it increases blood flow to the penis, which results in an erection.

This medicine should not be used as a sexual aid by men who do not have erectile dysfunction. If the medicine is not used properly, permanent damage to the penis and loss of the ability to have erections could result.

Phentolamine may also be used to reverse the effects of an anesthetic medicine in soft tissues, such as the lips and tongue. It may be used to help quickly restore normal sensation and function in patients who have received local dental anesthesia .

Phentolamine 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 this use is not included in product labeling, phentolamine is used in certain patients with the following medical conditions:

• Low doses of a three-drug combination of phentolamine, papaverine, and alprostadil as an injection may be used to treat erectile dysfunction.

Before Using OraVerse

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Appropriate studies have not been performed on the relationship of age to the effects of phentolamine for the reversal of soft-tissue anesthesia in children younger than 6 years of age. Safety and efficacy have not been established .

Geriatric

Many medicines have not been studied specifically in older people. Therefore, it may not be known whether they work exactly the same way they do in younger adults or if they cause different side effects or problems in older people. Although there is no specific information comparing the use of phentolamine for erectile dysfunction in the elderly, it is not expected to cause different side effects or problems in older people than it does in younger adults.

Pregnancy

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

Breast Feeding

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

Interactions with Medicines

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines 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.

• Tadalafil

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.

• Acebutolol


• Alprenolol


• Atenolol


• Betaxolol


• Bevantolol


• Bisoprolol


• Bucindolol


• Carteolol


• Carvedilol


• Celiprolol


• Dilevalol


• Esmolol


• Labetalol


• Levobunolol


• Mepindolol


• Metipranolol


• Metoprolol


• Nadolol


• Nebivolol


• Oxprenolol


• Penbutolol


• Pindolol


• Propranolol


• Sotalol


• Talinolol


• Tertatolol


• Timolol


• Vardenafil

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:

• Bleeding problems—These conditions increase the risk of bleeding at the place of injection.

• Priapism (history of) or


• Sickle cell disease—Patients with these conditions have an increased risk of priapism (erection lasting longer than 4 hours) while using phentolamine.

Proper Use of phentolamine

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

To give the injection:

• Cleanse the injection site with alcohol. Using a sterile needle, inject the medicine slowly and directly into the base of the penis as instructed by your doctor. It should not be injected just under the skin. The injection is usually not painful, although you may feel some tingling in the tip of your penis. If the injection is very painful or you notice bruising or swelling at the place of injection, that means you are injecting the medicine under the skin. Stop, withdraw the needle, and reposition it properly before continuing with the injection.


• After you have completed the injection, put pressure on the place of injection to prevent bruising. Then massage your penis as instructed by your doctor. This helps the medicine spread to all parts of the penis, so that it will work better.

This medicine usually begins to work in about 10 minutes. You should attempt intercourse within 2 hours after injecting the medicine.

To reverse the effects of a soft-tissue anesthetic medicine, a dentist or other trained health professional will give you this medicine. This medicine is usually injected at the same spot where you have received the local dental anesthesia .

Dosing

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

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

• For injection dosage form:
  
  • For the treatment of impotence:
    
    • Adults— 0.5 to 1 milligram (mg) injected very slowly into the area of your penis as directed by your doctor. Allow one or two minutes to completely inject the dose. Do not inject more than one dose in a day. Also, do not use this medicine more than two days in a row or more than three times a week.
    
    
  
  

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 OraVerse

Use the injection exactly as directed by your doctor. Do not use more of it and do not use it more often than ordered. If too much is used, the erection may become so strong that it lasts too long and does not reverse when it should. This condition is called priapism, and it can be very dangerous. If the effect is not reversed, the blood supply to the penis may be cut off and permanent damage may occur.

Contact your doctor immediately if the erection lasts for longer than 4 hours or if it becomes painful. This may be a sign of priapism and must be treated right away to prevent permanent damage.

If you notice bleeding at the site when you inject the medicine, put pressure on the spot until the bleeding stops. If it doesn't stop, check with your doctor.

It is important for you to examine your penis regularly. Check with your doctor if you find a lump where the medicine has been injected or if you notice that your penis is becoming curved. These may be signs that unwanted tissue is growing (called fibrosis), which should be seen by your doctor.

OraVerse Side Effects

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

Rare

• Dizziness


• erection continuing for more than 4 hours, or painful erection


• lumps in the penis

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

Less common or rare

• Bruising or bleeding at place of injection


• burning (mild) along penis


• difficulty in ejaculating


• swelling at place of injection

Phentolamine injected into the penis may cause tingling at the tip of the penis. This is no cause for concern.

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: OraVerse 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 OraVerse resources

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

• OraVerse Prescribing Information (FDA)


• OraVerse Consumer Overview


• Phentolamine Prescribing Information (FDA)


• Phentolamine Professional Patient Advice (Wolters Kluwer)


• Phentolamine Mesylate Monograph (AHFS DI)


• Regitine Prescribing Information (FDA)

Compare OraVerse with other medications

• Reversal of Anesthesia

Germolene Antiseptic Ointment

1. Name Of The Medicinal Product

Germolene Antiseptic Ointment

2. Qualitative And Quantitative Composition

Zinc Oxide Ph. Eur. 6.55%, Methyl Salicylate Ph. Eur. 3%, Phenol Ph. Eur. 1.19% and Octafonium Chloride 0.3%.

3. Pharmaceutical Form

Ointment for topical administration.

4. Clinical Particulars

4.1 Therapeutic Indications

For minor cuts and grazes, minor burns and scalds and blisters, sore or rough skin, wash-day hands, sunburn and the symptomatic relief of muscular pain and stiffness.

4.2 Posology And Method Of Administration

Minor cuts and grazes etc.: Clean the wound and apply directly or on a dressing.

Minor burns, scalds and blisters: Apply liberally and cover with a light bandage.

Sore, rough skin, wash-day hands, sunburn etc.: Apply directly and rub in gently.

Stiff, aching muscles: Apply liberally and massage in thoroughly.

4.3 Contraindications

Hypersensitivity to any of the ingredients.

4.4 Special Warnings And Precautions For Use

For external use only.

Keep out of the reach of children.

If symptoms persist, consult your doctor.

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

None known.

4.6 Pregnancy And Lactation

Use in pregnancy and lactation is not contraindicated. However, as with all medicines during pregnancy, caution should be exercised.

4.7 Effects On Ability To Drive And Use Machines

None.

4.8 Undesirable Effects

Local allergic reactions may occur. Very rarely, contact dermatitis may occur.

4.9 Overdose

It is very unlikely that overdose would occur with this pharmaceutical form. Theoretically, frequently repeated topical application on the same site could lead to skin irritation. However, since the product is only intended for minor skin trauma, extensive exposure is unlikely.

5. Pharmacological Properties

5.1 Pharmacodynamic Properties

Zinc oxide is a mild astringent. Methyl salicylate is a topical analgesic and anti-inflammatory. Phenol is an antiseptic and local anaesthetic. Octafonium chloride is an antiseptic. Wool fat, yellow soft paraffin, white soft paraffin, light liquid paraffin and starch all have emollient properties.

5.2 Pharmacokinetic Properties

Not applicable.

5.3 Preclinical Safety Data

There are no preclinical data of any relevance additional to that already included in other sections of the SmPC.

6. Pharmaceutical Particulars

6.1 List Of Excipients

Also contains wool fat Ph. Eur., yellow soft paraffin B. P., white soft paraffin B. P., light liquid paraffin Ph. Eur., starch Ph. Eur., menthol and colours: ponceau 4R (E124) & tartrazine (E102).

6.2 Incompatibilities

None.

6.3 Shelf Life

Three years.

6.4 Special Precautions For Storage

None.

6.5 Nature And Contents Of Container

Flexible aluminium tube, unlacquered internally, fitted with an integral nozzle and a polypropylene cap, containing 27g of ointment.

6.6 Special Precautions For Disposal And Other Handling

Replace closure firmly after use.

Administrative Data

7. Marketing Authorisation Holder

Bayer plc

Trading as: Bayer plc; Consumer Care Division

Bayer House

Strawberry Hill

Newbury

Berkshire

RG14 1JA

United Kingdom

8. Marketing Authorisation Number(S)

PL 00010/0262

9. Date Of First Authorisation/Renewal Of The Authorisation

1^st July 2000

10. Date Of Revision Of The Text

April 2007

Orinase

Generic Name: tolbutamide (tole BUE ta mide)

Brand Names: Orinase

What is Orinase (tolbutamide)?

Tolbutamide is an oral diabetes medicine that helps control blood sugar levels. This medication helps your pancreas produce insulin.

Tolbutamide is used together with diet and exercise to treat type 2 diabetes. Other diabetes medicines are sometimes used in combination with tolbutamide if needed.

Tolbutamide should not be used by itself to treat type 1 diabetes.

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

What is the most important information I should know about Orinase (tolbutamide)?

Do not use this medication if you are allergic to tolbutamide, or if you are in a state of diabetic ketoacidosis. Call your doctor for treatment with insulin.

Before taking tolbutamide, tell your doctor if you have kidney or liver disease, a disorder of your pituitary or adrenal glands, an enzyme deficiency called G6PD, a history of heart disease, or if you are malnourished.

Take care not to let your blood sugar get too low. Low blood sugar (hypoglycemia) can occur if you skip a meal, exercise too long, drink alcohol, or are under stress. Symptoms include headache, hunger, weakness, sweating, tremors, irritability, or trouble concentrating. Carry hard candy or glucose tablets with you in case you have low blood sugar. Other sugar sources include orange juice and milk. Be sure your family and close friends know how to help you in an emergency.

Also watch for signs of blood sugar that is too high (hyperglycemia). These symptoms include increased thirst, increased urination, hunger, dry mouth, fruity breath odor, drowsiness, dry skin, blurred vision, and weight loss. Your blood sugar will need to be checked often, and you may need to adjust your tolbutamide dose.

Tolbutamide is only part of a complete program of treatment that may also include diet, exercise, weight control, and testing your blood sugar. Follow your diet, medication, and exercise routines very closely. Changing any of these factors can affect your blood sugar levels.

What should I discuss with my doctor before taking Orinase (tolbutamide)?

Do not use this medication if you are allergic to tolbutamide, or if you are in a state of diabetic ketoacidosis. Call your doctor for treatment with insulin.

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

• liver disease;


• kidney disease;


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  a disorder of your pituitary or adrenal glands;

  
  


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  an enzyme deficiency called glucose-6-phosphate dehydrogenase deficiency (G6PD);

  
  


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  a history of heart disease; or

  
  


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  if you are malnourished.

  
  

Certain oral diabetes medications may increase your risk of serious heart problems. However, not treating your diabetes can damage your heart and other organs. Talk to your doctor about the risks and benefits of treating your diabetes with tolbutamide. FDA pregnancy category C. It is not known whether tolbutamide will harm an unborn baby. Similar diabetes medications have caused severe hypoglycemia in newborn babies whose mothers had used the medication near the time of delivery. Tell your doctor if you are pregnant or plan to become pregnant while using this medication. It is not known whether tolbutamide passes into breast milk or if it could be harmful to a nursing baby. You should not breast-feed while you are taking tolbutamide.

How should I take Orinase (tolbutamide)?

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.

Follow your doctor's instructions about how often to take tolbutamide, and whether or not you should take it with food.

Your blood sugar will need to be checked often, and you may need other blood tests at your doctor's office. Visit your doctor regularly.

Know the signs of low blood sugar (hypoglycemia) and how to recognize them: headache, hunger, weakness, sweating, tremor, irritability, or trouble concentrating.

Always keep a source of sugar available in case you have symptoms of low blood sugar. Sugar sources include orange juice, glucose gel, candy, or milk. If you have severe hypoglycemia and cannot eat or drink, use an injection of glucagon. Your doctor can give you a prescription for a glucagon emergency injection kit and tell you how to give the injection.

Also watch for signs of blood sugar that is too high (hyperglycemia). These symptoms include increased thirst, increased urination, hunger, dry mouth, fruity breath odor, drowsiness, dry skin, blurred vision, and weight loss.

Check your blood sugar carefully during a time of stress or illness, if you travel, exercise more than usual, drink alcohol, or skip meals. These things can affect your glucose levels and your dose needs may also change.

Your doctor may want you to stop taking tolbutamide for a short time if you become ill, have a fever or infection, or if you have surgery or a medical emergency.

Ask your doctor how to adjust your tolbutamide dose if needed. Do not change your medication dose or schedule without your doctor's advice.

Tolbutamide is only part of a complete program of treatment that may also include diet, exercise, weight control, and testing your blood sugar. Follow your diet, medication, and exercise routines very closely. Changing any of these factors can affect your blood sugar levels.

Use tolbutamide regularly to get the most benefit. Get your prescription refilled before you run out of medicine completely.

Store at room temperature away from moisture, heat, and light.

What happens if I miss a dose?

Take the missed dose as soon as you remember. Be sure to take the medication with food if your doctor instructs you to. 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. An overdose of tolbutamide can cause severe hypoglycemia.

Symptoms of severe hypoglycemia include extreme weakness, blurred vision, sweating, trouble speaking, tremors, stomach pain, confusion, and seizure (convulsions).

What should I avoid while taking Orinase (tolbutamide)?

Avoid drinking alcohol. It lowers blood sugar and may interfere with your diabetes treatment. Avoid exposure to sunlight or tanning beds. Tolbutamide can make you sunburn more easily. Wear protective clothing and use sunscreen (SPF 30 or higher) when you are outdoors.

Orinase (tolbutamide) 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.

Hypoglycemia, or low blood sugar, is the most common side effect of tolbutamide. Symptoms include headache, hunger, weakness, sweating, tremor, irritability, trouble concentrating, rapid breathing, fast heartbeat, fainting, or seizure (severe hypoglycemia can be fatal). Carry hard candy or glucose tablets with you in case you have low blood sugar.

Stop taking tolbutamide and call your doctor at once if you have a serious side effect such as:

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  easy bruising or bleeding, unusual weakness;

  
  


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  pale or yellowed skin, dark colored urine, fever, confusion; or

  
  


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  memory problems, loss of appetite, feeling unsteady, or hallucinations.

  
  

Less serious side effects may include:

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  mild nausea, heartburn, full feeling;

  
  


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  headache;

  
  


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  unusual or unpleasant taste in your mouth; or

  
  


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  skin rash, redness, or itching.

  
  

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 Orinase (tolbutamide)?

You may be more likely to have hyperglycemia (high blood sugar) if you take tolbutamide with other drugs that can raise blood sugar, such as:

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  isoniazid;

  
  


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  diuretics (water pills);

  
  


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  steroids (prednisone and others);

  
  


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  heart or blood pressure medication (Cartia, Cardizem, Covera, Isoptin, Verelan, and others);

  
  


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  niacin (Advicor, Niaspan, Niacor, Simcor, Slo-Niacin, and others);

  
  


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  phenothiazines (Compazine and others);

  
  


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  thyroid medicine (Synthroid and others);

  
  


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  birth control pills and other hormones;

  
  


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  seizure medicines (Dilantin and others);

  
  


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  diet pills or medicines to treat asthma, colds or allergies; and

  
  


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  heart or blood pressure medication such as diltiazem (Cartia, Cardizem), nifedipine (Nifedical, Procardia), verapamil (Calan, Covera, Isoptin, Verelan), and others.

  
  

You may be more likely to have hypoglycemia (low blood sugar) if you take tolbutamide with other drugs that can lower blood sugar, such as:

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  exenatide (Byetta);

  
  


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  probenecid (Benemid);

  
  


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  some nonsteroidal anti-inflammatory drugs (NSAIDs);

  
  


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  aspirin or other salicylates (including Pepto-Bismol);

  
  


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  a blood thinner (warfarin, Coumadin, Jantoven, and others);

  
  


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  heart or blood pressure medication (Accupril, Altace, Lotensin, Prinivil, Vasotec, Zestril, and others);

  
  


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  sulfa drugs (Bactrim, Gantanol, Gantrisin, Septra, SMX-TMP, and others);

  
  


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  a monoamine oxidase inhibitor (MAOI); or

  
  


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  other oral diabetes medications, especially acarbose (Precose), metformin (Glucophage), miglitol (Glyset), pioglitazone (Actos), or rosiglitazone (Avandia).

  
  

These lists are not complete and there are many other medicines that can increase or decrease the effects of tolbutamide on lowering your blood sugar. 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 Orinase resources

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

• Tol-Tab Advanced Consumer (Micromedex) - Includes Dosage Information


• Tolbutamide Prescribing Information (FDA)


• Tolbutamide Professional Patient Advice (Wolters Kluwer)


• Tolbutamide Monograph (AHFS DI)


• Tolbutamide MedFacts Consumer Leaflet (Wolters Kluwer)

Compare Orinase with other medications

• Diabetes, Type 2

Where can I get more information?

• Your pharmacist can provide more information about tolbutamide.

See also: Orinase side effects (in more detail)