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Friday, 7 September 2012

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 IV¹⁰¹ 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†

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†

Single dose of 250 units.¹⁰⁴

Treatment of Tetanus

Children†

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†

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.

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Tuesday, 4 September 2012

polycarbophil

Generic Name: polycarbophil (POL ee KAR boe fil)

Brand names: Equalactin, Fiber Lax, FiberCon, Fiberlax, Fibernorm, Konsyl Fiber, Perdiem Fiber Caplet, Mitrolan, Fiber Laxative, Fibertab, Polycarb, Fiberall Tablets

What is polycarbophil?

Polycarbophil is a bulk-forming laxative that increases the amount of water in your stools to help make them softer and easier to pass.

Polycarbophil is used to treat constipation and to help maintain regular bowel movements.

Polycarbophil may also be used in some cases to treat diarrhea or irritable bowel syndrome.

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

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

You should not use this medication if you are allergic to polycarbophil or to mineral oil, sodium laurel sulfate, or povidone (such as Betadine).

Before using polycarbophil, tell your doctor if you are allergic to any drugs, or if you have trouble swallowing, a blockage in your intestines, stomach pain with nausea or vomiting, a history of bleeding from your rectum, or a sudden change in your bowel habits that has lasted for 2 weeks or longer.

Ask your doctor before taking polycarbophil if you are pregnant or breast-feeding. The polycarbophil tablet may expand in your throat and cause you to choke if you do not use enough liquid to help swallow the pill. Be sure to drink a full 8-ounce glass of water or other liquid while swallowing the regular tablet or after chewing the chewable tablet.

Polycarbophil is usually taken up to 4 times per day. Do not take more than recommended by your doctor or listed on the medicine label.

Polycarbophil should cause you to have a bowel movement within 12 to 72 hours.

Do not take polycarbophil for longer than 7 days unless your doctor tells you to.

What should I discuss with my health care provider before taking polycarbophil?

You should not use this medication if you are allergic to polycarbophil or to mineral oil, sodium laurel sulfate, or povidone (such as Betadine).

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

trouble swallowing;

a blockage in your intestines;

stomach pain with nausea or vomiting;

a history of bleeding from your rectum; or

a sudden change in your bowel habits that has lasted for 2 weeks or longer.

If you have any of these conditions, you may not be able to take polycarbophil, or you may need a dose adjustment or special tests during treatment.

Ask your doctor before taking polycarbophil if you are pregnant or breast-feeding.

Some forms of polycarbophil may contain phenylalanine. Talk to your doctor before using this medication if you have phenylketonuria (PKU).

Do not give this medicine to a young child without the advice of a doctor.

How should I take polycarbophil?

Use this medication exactly as directed on the label, or as prescribed by your doctor. Do not use it in larger amounts or for longer than recommended.

Take this medicine with a full glass (8 ounces) of water or other liquid. The tablet may expand in your throat and cause you to choke if you do not use enough liquid to help swallow the pill. Unless you need to restrict your fluid intake, drink plenty of fluids each day while you are taking polycarbophil.

The chewable tablet must be chewed before your swallow it.

Older adults may be more likely to choke while taking this medication. Be sure to drink a full glass of water while swallowing the regular tablet, or after chewing the chewable tablet.

Polycarbophil is usually taken up to 4 times per day. Do not take more of this medicine than recommended by your doctor or printed on the medicine label.

Polycarbophil should cause you to have a bowel movement within 12 to 72 hours. Call your doctor if your constipation does not improve after 3 days of taking this medication.

Do not take polycarbophil for longer than 7 days unless your doctor tells you to. Overuse of a laxative may cause damage to the nerves, muscles, or tissues in your intestines. Store polycarbophil at room temperature away from moisture and heat.

What happens if I miss a dose?

Since polycarbophil is usually taken as needed, you will not be on a long-term dosing schedule. If you are taking the medication daily for up to 7 days, take the missed dose as soon as you remember. If it is almost time for your next dose, wait until then to take the medicine and skip the missed dose. Do not take extra medicine to make up the missed dose.

What happens if I overdose?

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

An overdose of polycarbophil is not likely to produce life-threatening side effects.

What should I avoid while taking polycarbophil?

Avoid taking polycarbophil within 2 hours before or after you take any other medications. A laxative can make it harder for your body to absorb other medicines.

Polycarbophil side effects

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

vomiting;

choking on the tablet;

trouble swallowing;

chest pain; or

rectal bleeding.

Less serious side effects may include:

mild stomach pain;

bloating; or

gas.

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 polycarbophil?

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

More polycarbophil resources

Drug Images
Polycarbophil Drug Interactions
Polycarbophil Support Group
1 Review for Polycarbophil - Add your own review/rating

Compare polycarbophil with other medications

Constipation

Where can I get more information?

Your pharmacist can provide more information about polycarbophil.

Monday, 3 September 2012

imipramine

im-IP-ra-meen

Oral route(Tablet)

Antidepressants increased the risk of suicidal thinking and behavior in children, adolescents, and young adults in short-term studies with major depressive disorder (MDD) and other psychiatric disorders. Short term studies did not show an increase in the risk of suicidality with antidepressants compared to placebo in adults beyond age 24, and there was a reduction in risk with antidepressants compared to placebo in adults aged 65 and older. This risk must be balanced with the clinical need. Monitor patients closely for clinical worsening, suicidality, or unusual changes in behavior. Families and caregivers should be advised of the need for close observation and communication with the prescriber. Not approved for use in pediatric patients except for patients with nocturnal enuresis .

Oral route(Capsule)

Commonly used brand name(s)

In the U.S.

Tofranil

Tofranil-PM

Available Dosage Forms:

Tablet

Capsule

Therapeutic Class: Antidepressant

Pharmacologic Class: Antidepressant, Tricyclic

Uses For imipramine

Imipramine is used to treat the symptoms of depression. It works on the central nervous system (CNS) to increase levels of certain chemicals in the brain. imipramine is a tricyclic antidepressant (TCA).

Imipramine tablets are also used to treat enuresis (bedwetting) in children.

imipramine is available only with your doctor's prescription.

Before Using imipramine

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 imipramine, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to imipramine 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 imipramine capsules in the pediatric population. Safety and efficacy have not been established.

Appropriate studies have not been performed on the relationship of age to the effects of imipramine tablets in children with enuresis (bedwetting) under 6 years of age. Safety and efficacy have not been established.

Geriatric

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of imipramine in the elderly. However, elderly patients are more likely to have age-related kidney, liver, or heart problems, which may require an adjustment in the dose for patients receiving imipramine.

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 imipramine, 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 imipramine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.

Bepridil

Cisapride

Clorgyline

Dronedarone

Grepafloxacin

Isocarboxazid

Levomethadyl

Linezolid

Mesoridazine

Methylene Blue

Metoclopramide

Moclobemide

Phenelzine

Pimozide

Ranolazine

Selegiline

Sparfloxacin

Terfenadine

Thioridazine

Tranylcypromine

Using imipramine 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.

Acecainide

Alfuzosin

Amiodarone

Amisulpride

Amitriptyline

Amoxapine

Amprenavir

Apomorphine

Aprindine

Arsenic Trioxide

Asenapine

Astemizole

Atazanavir

Azimilide

Azithromycin

Bretylium

Chloral Hydrate

Chloroquine

Chlorpromazine

Ciprofloxacin

Clarithromycin

Clomipramine

Clonidine

Clozapine

Crizotinib

Darifenacin

Dasatinib

Desipramine

Dextromethorphan

Disopyramide

Dofetilide

Dolasetron

Droperidol

Enflurane

Epinephrine

Erythromycin

Etilefrine

Flecainide

Fluconazole

Fluoxetine

Foscarnet

Gatifloxacin

Gemifloxacin

Granisetron

Halofantrine

Haloperidol

Halothane

Ibutilide

Iloperidone

Indacaterol

Iproniazid

Isoflurane

Isradipine

Lapatinib

Levofloxacin

Lidoflazine

Lorcainide

Lumefantrine

Mefloquine

Methadone

Methoxamine

Midodrine

Moricizine

Moxifloxacin

Nefopam

Nialamide

Nilotinib

Norepinephrine

Norfloxacin

Nortriptyline

Octreotide

Ofloxacin

Oxilofrine

Paliperidone

Pargyline

Pazopanib

Pentamidine

Perflutren Lipid Microsphere

Phenylephrine

Posaconazole

Procainamide

Procarbazine

Prochlorperazine

Promethazine

Propafenone

Protriptyline

Quetiapine

Quinidine

Quinine

Rasagiline

Risperidone

Saquinavir

Sematilide

Sertindole

Sertraline

Sodium Phosphate

Sodium Phosphate, Dibasic

Sodium Phosphate, Monobasic

Solifenacin

Sorafenib

Sotalol

Spiramycin

Sulfamethoxazole

Sultopride

Sunitinib

Tapentadol

Tedisamil

Telavancin

Telithromycin

Tetrabenazine

Toloxatone

Toremifene

Tramadol

Trazodone

Trifluoperazine

Trimethoprim

Vandetanib

Vardenafil

Vasopressin

Vemurafenib

Venlafaxine

Voriconazole

Ziprasidone

Zolmitriptan

Zotepine

Using imipramine 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.

Acenocoumarol

Alprazolam

Arbutamine

Atomoxetine

Butalbital

Cannabis

Carbamazepine

Cimetidine

Citalopram

Dicumarol

Fenfluramine

Fluvoxamine

Mibefradil

Paroxetine

Phenindione

Phenprocoumon

Phenytoin

Ritonavir

S-Adenosylmethionine

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using imipramine with any of the following may cause an increased risk of certain side effects but may be unavoidable in some cases. If used together, your doctor may change the dose or how often you use imipramine, or give you special instructions about the use of food, alcohol, or tobacco.

Ethanol

Proper Use of imipramine

Take imipramine only as directed by your doctor to benefit your condition as much as possible. Do not take more of it, do not take it more often, and do not take it for a longer time than your doctor ordered.

imipramine comes with a medication guide. Read and follow these instructions carefully. Ask your doctor if you have any questions.

Dosing

The dose of imipramine 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 imipramine. 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 (capsules):
- For depression:
  - Adults—At first, 75 milligrams (mg) once a day. Your doctor may adjust your dose as needed. However, the dose is usually not more than 200 mg per day, unless you are in the hospital. Some hospitalized patients may need higher doses.
  - Teenagers and Older Adults—At first, 25 to 50 milligrams (mg) per day using the tablets. Your doctor may adjust your dose as needed and switch you to the capsule form. However, the dose is usually not more than 100 mg per day.
  - Children—Use and dose must be determined by your doctor.

For oral dosage form (tablets):
- For depression:
  - Adults—At first, 75 milligrams (mg) per day. Your doctor may adjust your dose as needed. However the dose is usually not more than 200 mg per day. Some hospitalized patients may need higher doses.
  - Teenagers and Older Adults—30 to 40 milligrams (mg) per day. Your doctor may adjust your dose as needed. However, the dose is usually not more than 100 mg per day.
  - Children—Use and dose must be determined by your doctor.
- For enuresis (bedwetting):
  - Children 6 years of age and older—At first, 25 milligrams (mg) once a day, taken one hour before bedtime. Your doctor may adjust the dose as needed.
  - Children below 6 years of age—Use and dose must be determined by your doctor.

Missed Dose

If you miss a dose of imipramine, 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.

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

Do not keep outdated medicine or medicine no longer needed.

Precautions While Using imipramine

It is very important that your doctor check your progress at regular visits to allow for changes in your dose and to check for any unwanted effects. Blood tests may be needed to check for any unwanted effects. Check with your doctor right away if you start having a fever or sore throat while taking imipramine.

Imipramine may cause some people to be agitated, irritable, or display other abnormal behaviors. It may also cause some people to have suicidal thoughts and tendencies or to become more depressed. If you, your child, or your caregiver notice any of these side effects, tell your doctor or your child's doctor right away.

Do not take imipramine if you have taken a monoamine oxidase (MAO) inhibitor (isocarboxazid [Marplan®], phenelzine [Nardil®], selegiline [Eldepryl®, or tranylcypromine [Parnate®]) in the past two weeks. Do not start taking a MAO inhibitor within 5 days of stopping imipramine. If you do, you may develop confusion, agitation, restlessness, stomach or intestinal symptoms, sudden high body temperature, extremely high blood pressure, or severe convulsions.

Do not stop taking imipramine without first checking with your doctor. Your doctor may want you to gradually reduce the amount you are using before stopping it completely. This may help prevent a possible worsening of your condition and reduce the possibility of withdrawal symptoms, such as headache, nausea, or a general feeling of discomfort or illness.

imipramine will add to the effects of alcohol and other central nervous system (CNS) depressants (medicines that cause drowsiness). Some examples of CNS depressants are antihistamines or medicine for hay fever, other allergies or colds; sedatives, tranquilizers, or sleeping medicines; prescription pain medicine or narcotics; barbiturates; medicine for seizures; muscle relaxants; or anesthetics, including some dental anesthetics. Check with your doctor before taking any of the above while you are using imipramine.

Before having any kind of surgery, tell the medical doctor in charge that you are using imipramine. Taking imipramine together with medicines used during surgery may increase the risk of side effects.

imipramine may affect blood sugar levels. If you notice a change in the results of your blood or urine sugar tests, or if you have any questions, check with your doctor.

imipramine may make your skin more sensitive to sunlight. Use a sunscreen when you are outdoors. Avoid sunlamps and tanning beds.

imipramine may cause some people to become drowsy or less alert than they are normally. Make sure you know how you react to imipramine before you drive, use machines, or do anything else that could be dangerous if you are drowsy or not alert.

imipramine 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

Abdominal or stomach pain

actions that are out of control

agitation

anxiety

black, tarry stools

bleeding and bruising

bleeding gums

blood in urine or stools

blurred vision burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings

chest pain or discomfort

clay-colored stools

cold sweats

coma

confusion about identity, place, and time

continuing ringing or buzzing or other unexplained noise in ears

convulsions

cool, pale skin

cough or hoarseness

dark urine

decrease in frequency of urination

decreased urine output or volume

depression

difficulty in passing urine (dribbling)

difficulty in speaking

dizziness, faintness, or lightheadedness when getting up from a lying or sitting position suddenly

double vision

drooling

dry mouth

false beliefs that cannot be changed by facts

fast, pounding, or irregular heartbeat or pulse

fear or nervousness

feeling of warmth

feeling, seeing, or hearing things that are not there

feeling that others are watching you or controlling your behavior

feeling that others can hear your thoughts

fever with or without chills

flushed, dry skin

fruit-like breath odor

general feeling of tiredness or weakness

headache

hearing loss

hostility

hyperventilation

inability to move arms, legs, or facial muscles

inability to speak

increased hunger

increased need to urinate

increased thirst

increased urination

irritability

itching

lack of coordination

lethargy

loss of appetite

loss of balance control

lower back or side pain

mood or mental changes

muscle spasm or jerking of all extremities

muscle trembling, jerking, or stiffness

muscle twitching

nausea

nightmares

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

painful or difficult urination

passing urine more often

perspiration

pinpoint red or purple spots on skin

pounding in the ears

rapid weight gain

rash

redness of the face, neck, arms, and occasionally, upper chest

restlessness

seizures

shakiness and unsteady walk

shortness of breath

shuffling walk

sleeplessness

slow speech

slurred speech

sore throat

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

stiffness of limbs

stupor

sudden loss of consciousness

sweating

swelling of face, ankles, legs, or hands

swollen glands

talking, feeling, and acting with excitement

trouble in holding or releasing urine

trouble sleeping

twisting movements of body

unable to sleep

uncontrolled movements, especially of face, neck, and back

unpleasant breath odor

unsteadiness, awkwardness, trembling, or other problems with muscle control or coordination

unusual behavior

unusual bleeding or bruising

unusual tiredness or weakness

vomiting of blood

weakness in arms, hands, legs, or feet

weight gain or loss

yellow eyes or skin

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

Symptoms of overdose

Bluish color of fingernails, lips, skin, palms, or nail beds

change in consciousness

cold clammy skin

confusion

decreased awareness or responsiveness

difficult or troubled breathing

difficulty sleeping

disorientation

drowsiness to profound coma

fast, weak pulse

hallucination increased or excessive unconscious or jerking movements

irregular, fast, slow, or shallow breathing

lethargy

loss of consciousness

mood or other mental changes

muscle stiffness or tightness

pale or blue lips, fingernails, or skin

severe sleepiness

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:

Incidence not known

Abdominal cramps

bigger, dilated, or enlarged pupils (black part of eye)

black tongue

bloating

decreased interest in sexual intercourse

diarrhea

difficulty having a bowel movement (stool)

disturbance of accommodation

enlargement of the breast

hair loss, thinning of hair

heartburn

hives or welts

inability to have or keep an erection

increased in sexual ability, desire, drive, or performance

increased interest in sexual intercourse

increased sensitivity of eyes to light

increased sensitivity of skin to sunlight

increased urge to urinate during the night

loss in sexual ability, desire, drive, or performance

pain or discomfort in chest, upper stomach, or throat

peculiar taste

redness or other discoloration of skin

severe sunburn

small red or purple spots on skin

swelling of testicles

swelling of the breasts or breast soreness in both females and males

swelling or inflammation of the mouth

swollen, painful, or tender lymph glands on side of face or neck

unexpected or excess milk flow from breasts

waking to urinate at night

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: imipramine 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 imipramine resources

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

imipramine Concise Consumer Information (Cerner Multum)

Imipramine Prescribing Information (FDA)

Imipramine MedFacts Consumer Leaflet (Wolters Kluwer)

Imipramine Professional Patient Advice (Wolters Kluwer)

Imipramine Hydrochloride Monograph (AHFS DI)

Tofranil Prescribing Information (FDA)

Tofranil-PM Prescribing Information (FDA)

Tofranil-PM MedFacts Consumer Leaflet (Wolters Kluwer)

Compare imipramine with other medications

ADHD
Depression
Interstitial Cystitis
Irritable Bowel Syndrome
Night Terrors
Pain
Panic Disorder
Primary Nocturnal Enuresis

Sunday, 2 September 2012

Slow-Mag Sustained-Release Tablets

Pronunciation: mag-NEE-zee-um KLOR-ide
Generic Name: Magnesium Chloride
Brand Name: Examples include Mag-SR and Slow-Mag

Slow-Mag Sustained-Release Tablets are used for:

Treating low magnesium levels or maintaining the proper amount of magnesium in the body. It also may be used for other conditions as determined by your doctor.

Slow-Mag Sustained-Release Tablets are an essential mineral. It works by adding magnesium to your body if your magnesium levels are low.

Do NOT use Slow-Mag Sustained-Release Tablets if:

you are allergic to any ingredient in Slow-Mag Sustained-Release Tablets

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

Before using Slow-Mag Sustained-Release Tablets:

Some medical conditions may interact with Slow-Mag Sustained-Release Tablets. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

if you are pregnant, planning to become pregnant, or are breast-feeding

if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement

if you have allergies to medicines, foods, or other substances

if you have appendicitis, diarrhea, a blockage of your intestines, heart problems, or kidney problems

Some MEDICINES MAY INTERACT with Slow-Mag Sustained-Release Tablets. Tell your health care provider if you are taking any other medicines, especially any of the following:

Anticoagulants (eg, warfarin) because the risk of their side effects may be increased by Slow-Mag Sustained-Release Tablets

Bisphosphonates (eg, risedronate), digoxin, penicillamine, quinolone antibiotics (eg, ciprofloxacin), or tetracyclines (eg, doxycycline) because their effectiveness may be decreased by Slow-Mag Sustained-Release Tablets

This may not be a complete list of all interactions that may occur. Ask your health care provider if Slow-Mag Sustained-Release Tablets may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use Slow-Mag Sustained-Release Tablets:

Use Slow-Mag Sustained-Release Tablets as directed by your doctor. Check the label on the medicine for exact dosing instructions.

Take Slow-Mag Sustained-Release Tablets by mouth with food.

If you miss a dose of Slow-Mag Sustained-Release Tablets and are using it regularly, take it as soon as possible. If it is almost time for the next dose, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once.

Ask your health care provider any questions you may have about how to use Slow-Mag Sustained-Release Tablets.

Important safety information:

Tell your doctor or dentist that you take Slow-Mag Sustained-Release Tablets before you receive any medical or dental care, emergency care, or surgery.

Lab tests, including magnesium levels, may be performed while you use Slow-Mag Sustained-Release Tablets. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.

Slow-Mag Sustained-Release Tablets should be used with extreme caution in CHILDREN; safety and effectiveness in children have not been confirmed.

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

Possible side effects of Slow-Mag Sustained-Release Tablets:

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Diarrhea.

Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); nausea; slow reflexes.

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

See also: Slow-Mag side effects (in more detail)

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately. Symptoms may include confusion; dizziness; flushing; loss of consciousness; muscle weakness; severe drowsiness; slow heartbeat.

Proper storage of Slow-Mag Sustained-Release Tablets:

Store Slow-Mag Sustained-Release Tablets at room temperature, between 68 and 77 degrees F (20 and 25 degrees C). Store away from heat, moisture, and light. Do not store in the bathroom. Keep Slow-Mag Sustained-Release Tablets out of the reach of children and away from pets.

General information:

If you have any questions about Slow-Mag Sustained-Release Tablets, please talk with your doctor, pharmacist, or other health care provider.

Slow-Mag Sustained-Release Tablets are to be used only by the patient for whom it is prescribed. Do not share it with other people.

If your symptoms do not improve or if they become worse, check with your doctor.

Check with your pharmacist about how to dispose of unused medicine.

This information is a summary only. It does not contain all information about Slow-Mag Sustained-Release Tablets. If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.

Issue Date: February 1, 2012

Database Edition 12.1.1.002

More Slow-Mag resources

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

Compare Slow-Mag with other medications

Heart Attack
Hypomagnesemia

Saturday, 1 September 2012

Migrazone

Generic Name: isometheptene, dichloralphenazone, and acetaminophen (Oral route)

eye-soe-meth-EP-teen MUE-kate, dye-klor-al-FEN-a-zone, a-seet-a-MIN-oh-fen

Commonly used brand name(s)

In the U.S.

Amidrine

Diacetazone

Duradrin

Epidrin

Iso-Acetazone

Midrin

Migquin

Migratine

Migrazone

Migrin-A

Nodolor

Va-Zone

Available Dosage Forms:

Capsule

Therapeutic Class: Acetaminophen Combination

Pharmacologic Class: Isometheptene

Uses For Migrazone

Isometheptene, dichloralphenazone, and acetaminophen combination is used to treat certain kinds of headaches, such as “tension” headaches and migraine headaches. This combination is not used regularly (for example, every day) to prevent headaches. It should be taken only after headache pain begins, or after a warning sign that a migraine is coming appears. Isometheptene helps to relieve throbbing headaches, but it is not an ordinary pain reliever. Dichloralphenazone helps you to relax, and acetaminophen relieves pain.

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

Before Using Migrazone

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

Allergies

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

Pediatric

Studies with this medicine have been done only in adult patients, and there is no specific information about its use in children.

Geriatric

Many medicines have not been tested 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. There is no specific information comparing use of this combination medicine in the elderly with use in other age groups.

Breast Feeding

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 not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.

Clorgyline

Iproniazid

Isocarboxazid

Moclobemide

Nialamide

Pargyline

Phenelzine

Procarbazine

Selegiline

Toloxatone

Tranylcypromine

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.

Bromocriptine

Fospropofol

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.

Acenocoumarol

Carbamazepine

Isoniazid

Phenytoin

Warfarin

Zidovudine

Interactions with Food/Tobacco/Alcohol

Using this medicine with any of the following is usually not recommended, but may be unavoidable in some cases. If used together, your doctor may change the dose or how often you use this medicine, or give you special instructions about the use of food, alcohol, or tobacco.

Ethanol

Using this medicine with any of the following may cause an increased risk of certain side effects but may be unavoidable in some cases. If used together, your doctor may change the dose or how often you use this medicine, or give you special instructions about the use of food, alcohol, or tobacco.

Cabbage

Proper Use of isometheptene, dichloralphenazone, and acetaminophen

This section provides information on the proper use of a number of products that contain isometheptene, dichloralphenazone, and acetaminophen. It may not be specific to Migrazone. Please read with care.

Take this medicine only as directed by your doctor. Do not take more of it, do not take it more often than directed, and do not take it every day for several days in a row. If the amount you are to take does not relieve your headache, check with your doctor. If a headache medicine is used too often, it may lose its effectiveness or even cause a type of physical dependence. If this occurs, your headaches may actually get worse. Also, taking too much acetaminophen can cause liver damage.

This medicine works best if you:

Take it as soon as the headache begins. If you get warning signals of a migraine, take this medicine as soon as you are sure that the migraine is coming. This may even stop the headache pain from occurring.

Lie down in a quiet, dark room until you are feeling better.

People who get a lot of headaches may need to take a different medicine to help prevent headaches. It is important that you follow your doctor's directions, even if your headaches continue to occur. Headache-preventing medicines may take several weeks to start working. Even after they do start working, your headaches may not go away completely. However, your headaches should occur less often, and they should be less severe and easier to relieve, than before. This will reduce the amount of headache relievers that you need. If you do not notice any improvement after several weeks of headache-preventing treatment, check 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.

For “tension” headaches:
- Adults: 1 or 2 capsules every 4 hours, as needed. Not more than 8 capsules a day.
- Children: Dose must be determined by the doctor.

For migraine headaches:
- Adults: 2 capsules for the first dose, then 1 capsule every hour, as needed. Not more than 5 capsules in 12 hours.
- Children: Dose must be determined by the doctor.

Precautions While Using Migrazone

Check with your doctor:

If the medicine stops working as well as it did when you first started using it. This may mean that you are in danger of becoming dependent on the medicine. Do not try to get better relief by increasing the dose.

If you are having headaches more often than you did before you started using this medicine. This is especially important if a new headache occurs within 1 day after you took your last dose of headache medicine, headaches begin to occur every day, or a headache continues for several days in a row. This may mean that you are dependent on the medicine. Continuing to take this medicine will cause even more headaches later on. Your doctor can give you advice on how to relieve the headaches.

Check the labels of all nonprescription (over-the-counter [OTC]) and prescription medicines you now take. Taking other medicines that contain acetaminophen together with this medicine may lead to an overdose. If you have any questions about this, check with your health care professional.

This medicine may cause some people to become drowsy, dizzy, or less alert than they are normally. These effects may be especially severe if you also take CNS depressants (medicines that slow down the nervous system, possibly causing drowsiness) together with this medicine. Some examples of CNS depressants are antihistamines or medicine for hay fever, other allergies, or colds; sedatives, tranquilizers, or sleeping medicine; prescription pain medicine or narcotics; barbiturates; medicine for seizures; muscle relaxants; antiemetics (medicines that prevent or relieve nausea or vomiting), and anesthetics. If you are not able to lie down for a while, make sure you know how you react to this medicine or combination of medicines before you drive, use machines, or do anything else that could be dangerous if you are drowsy or dizzy or are not alert.

Do not drink alcoholic beverages while taking this medicine. To do so may increase the chance of liver damage caused by acetaminophen, especially if you drink large amounts of alcoholic beverages regularly. Also, because drinking alcoholic beverages may make your headaches worse or cause new headaches to occur, people who often get headaches should probably avoid alcohol.

Migrazone Side Effects

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

Check with your doctor as soon as possible if any of the following side effects occur:

Less common

Unusual tiredness or weakness

Rare

Black, tarry stools

blood in urine or stools

pinpoint red spots on skin

skin rash, hives, or itching

sore throat and fever

unusual bleeding or bruising

yellow eyes or skin

Symptoms of dependence on this medicine

Headaches, more severe and/or more frequent than before

Symptoms of acetaminophen overdose

Diarrhea

increased sweating

loss of appetite

nausea or vomiting

pain, tenderness, and/or swelling in the upper abdominal (stomach) area

stomach cramps or pain

More common

Drowsiness

Rare

Dizziness

fast or irregular heartbeat

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: Migrazone side effects (in more detail)

More Migrazone resources

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

Migrazone Concise Consumer Information (Cerner Multum)

Duradrin MedFacts Consumer Leaflet (Wolters Kluwer)

Compare Migrazone with other medications

Headache

Prepcat Suspension

barium sulfate

Dosage Form: suspension
LAFAYETTE

PREPCAT™

BARIUM SULFATE SUSPENSION

FOR COMPUTED TOMOGRAPHY

Rx only

Prepcat Suspension Description

Prepcat is a strawberry flavored ready-to-use barium sulfate suspension for use as an aid for computed tomography of the gastrointestinal tract.

The contrast medium contains 1.5% w/w (w/v) barium sulfate USP, with sorbitol, simethicone, suspending agent, potassium sorbate, flavoring, citric acid, saccharin sodium and water. Barium sulfate has the empirical formula BaSO4.

Prepcat Suspension - Clinical Pharmacology

Barium sulfate is an insoluble material which, because of its density, provides a positive contrast during x-ray examination. Barium sulfate is an inert radiopaque material which is not absorbed or metabolized and is eliminated intact from the body in a manner similar to other non-absorbed inorganic materials. Excretion rate is a function of gastrointestinal transit time.

Indications and Usage for Prepcat Suspension

Prepcat is indicated for use as a diagnostic aid (contrast medium) for computed tomography of the gastrointestinal tract.

Contraindications

Barium sulfate products are contraindicated in patients with known or suspected obstruction of the colon, known or suspected gastrointestinal tract perforation, suspected tracheoesophageal fistula, obstructing lesions of the small intestine, pyloric stenosis or known hypersensitivity to barium sulfate formulations.

Barium sulfate suspensions should not be used for infants with swallowing disorders or for newborns with complete duodenal or jejunal obstruction or when distal small bowel or colon obstruction is suspected. Barium sulfate suspension is not recommended for very small preterm infants and young babies requiring small volumes of contrast media or for infants and young children when there is a possibility of leakage from the gastrointestinal tract, such as necrotizing enterocolitis, unexplained pneumoperitoneum, gasless abdomen, other bowel perforation, esophageal perforation or post operative anastomosis.

Known hypersensitivity or allergy to latex is a contraindication for the use of balloon retention enema tips containing latex.

The use of a retention cuff enema tip is not necessary or desirable in patients with normal sphincter tone. The presence of adequate sphincter tone can be judged by preliminary rectal digital examination.

Warnings

Serious adverse reactions, including death, have been reported with the administration of barium sulfate formulations and are usually associated with the technique of administration, the underlying pathological condition and/or patient hypersensitivities.

Diarrhea, with or without cramping, has been reported following oral administration of barium sulfate suspension. It is usually associated with the large volume of suspension used for CT examinations. The frequency of diarrhea is normally reduced by giving small volumes of suspension in divided doses.

Vomiting following oral administration of barium sulfate may lead to aspiration pneumonitis. Oral administration of barium sulfate suspension by an infant sucking a bottle and administration of large quantities by catheter are reported to be likely to result in aspiration into the tracheobronchial tree. Cardiopulmonary arrest leading to fatality has been reported in infants following aspiration. Aspiration of smaller amounts may cause inflammation.

Barium sulfate preparations used as radiopaque media contain a number of additives to provide diagnostic properties and patient palatability. Allergic responses following the use of barium sulfate suspensions have been reported. Skin irritation, redness, inflammation and hives have been reported for infants and small children following spillage of barium sulfate suspension on their skin. These responses are thought to be caused by the flavors and/or preservatives used in the product.

Barium sulfate suspension has been reported to cause obstruction of the small bowel (impaction) in pediatric patients with cystic fibrosis. It has also been reported to cause fluid overload from the absorption of water during studies in infants when Hirschsprung’s Disease is suspected.

In patients with increased cranial pressure, barium sulfate suspension enemas present an additional risk of further increasing intracranial pressure.

Care must be taken during the insertion of an enema tip into the patient to prevent application of pressure to the vagus nerve which can lead to vasovagal reactions and syncopal episodes. Cardiac arrhythmia or other cardiovascular side effects can occur as a result of colon distention.

Precautions

General

Diagnostic procedures which involve the use of radiopaque contrast agents should be carried out under the direction of personnel with the requisite training and with a thorough knowledge of the particular procedure to be performed. A history of bronchial asthma, atopy, as evidenced by hay fever and eczema, a family history of allergy, or a previous reaction to a contrast agent warrant special attention. Caution should be exercised with the use of radiopaque media in severely debilitated patients and in those with marked hypertension or advanced cardiac disease.

An increased risk of perforation has been reported in neonates with intussusception. In patients with cystic fibrosis or blind loops of the bowel or ileus, there is a risk of inspissation leading to partial or complete obstruction.

In neonates and infants with motility disorders such as Hirschsprung’s Disease retention of large amounts of barium sulfate suspension may result in absorption of water from the suspension and fluid overload. The addition of small amounts of salt to the barium sulfate suspension has been reported to reduce the problem.

Ingestion of barium sulfate suspension is not recommended in patients with a history of food aspiration. If barium sulfate suspension is aspirated into the larynx, further administration of the suspension should be immediately discontinued.

Patient preparation for diagnostic gastrointestinal examinations frequently requires cathartics and a liquid diet. The various preparations can result in water loss for the patient. Patients should be rehydrated quickly following a barium sulfate suspension examination of the gastrointestinal tract. In patients with reduced colon motility, saline cathartics may be required after the barium sulfate suspension enema. Saline cathartics are recommended on a routine basis in patients with a history of constipation unless clinically contraindicated.

Where enema tips are used, care must be taken during insertion into the patient, since forceful or too deep insertion may cause tearing or perforation of the rectum. When balloon retention tips are used, care should be taken to avoid overinflation of the balloon, since overfilling or asymmetrical filling with displacement of the tip may occur. Such a displacement can lead to rectal perforation or barium sulfate granulomas. Inflation of the balloon should be done under fluoroscopic control by qualified medical personnel. Do not unnecessarily move the enema tip once inserted.

A specially designed enema tip is required for a barium sulfate suspension examination of a colostomy patient.

Intubation of an enteroclysis catheter should be done by qualified medical personnel. Perforation of the duodenum has been reported.

Because of reported anaphylactoid reactions to latex, the use of non-latex gloves during the procedure should be considered.

Pregnancy

Safe use of barium sulfate during pregnancy has not been established. Barium sulfate should be used in pregnant women only if the possible benefits outweigh the potential risks. Elective radiography of the abdomen is considered to be contraindicated during pregnancy due to the risk to the fetus from radiation exposure. Radiation is known to cause harm to the unborn fetus exposed in utero.

Pediatric Use

The radiographic contrast agents used for examination of children do not differ substantially from those used for adults. The variation in physical sizes of pediatric patients requires more thorough attention to individualizing dosage. The volume of barium sulfate suspension and the barium sulfate content required will also depend upon the technique used and the clinical need.

Adverse Reactions

Adverse reactions accompanying the use of barium sulfate formulations are infrequent and usually mild, though severe reactions (approximately 1 in 500,000) and fatalities (approximately 1 in 2,000,000) have occurred. Procedural complications are rare, but may include aspiration pneumonitis, barium sulfate impaction, granuloma formation, intravasation, embolization and peritonitis following intestinal perforation, vasovagal and syncopal episodes, and fatalities. EKG changes have been shown to occur following or during barium sulfate suspension enemas. It is of the utmost importance to be completely prepared to treat any such occurrence.

Due to the increased likelihood of allergic reactions in atopic patients, a complete history of known and suspected allergies as well as allergic-like symptoms, such as rhinitis, bronchial asthma, eczema and urticaria, must be obtained prior to any medical procedure.

Aspiration of large amounts of barium sulfate suspension may cause pneumonitis or nodular granulomas of interstitial lung tissues and lymph nodes; asphyxiation and death have been reported.

Transient bacteremia, beginning almost immediately and lasting up to 15 minutes, may also occur during rectal administration of barium sulfate suspension, and rarely septicemia has been reported.

A rare mild allergic reaction would most likely be generalized pruritus, erythema or urticaria (approximately 1 in 100,000 reactions). Such reactions will often respond to an antihistamine. More serious reactions (approximately 1 in 500,000) may result in laryngeal edema, bronchospasm or hypotension.

Severe reactions which may require emergency measures are often characterized by peripheral vasodilation, hypotension, reflex tachycardia, dyspnea, bronchospasm, agitation, confusion and cyanosis, progressing to unconsciousness. Treatment should be initiated immediately according to established standard of care.

Apprehensive patients may develop weakness, pallor, tinnitus, diaphoresis and bradycardia following the administration of any diagnostic agent. Such reactions are usually non-allergic in nature.

Allergic reactions to the enema accessories, in particular to retention catheters (tips) with latex cuffs, can occur. Such reactions could occur immediately and result in the previously mentioned acute allergic-like responses or might be delayed in appearance and result in a contact dermatitis. Known atopic patients, particularly those with a history of asthma or eczema, should be evaluated for alternative methods of administration in order to avoid these adverse reactions. These plastic/rubber accessories are disposable, single-use devices that must not be reused or left in the body cavity for an extended period of time.

Postmarketing Experiences

The following adverse experiences have been reported in patients receiving products containing barium sulfate. These adverse experiences are listed alphabetically: abdominal cramping, abdominal pain, diarrhea, fever, foreign body trauma relating to procedural complications, headache, laryngeal burning and irritation, leukocytosis, nausea, procedural site reactions, rash and vomiting.

Overdosage

In rare instances, immediate repeat oral examinations utilizing standard dosages may lead to severe stomach cramps and diarrhea. Cases reported implicate a total dose in the range of 30 ounces (900 mL) of suspension. Instances of this type have resolved spontaneously and they are not considered to be life-threatening.

Prepcat Suspension Dosage and Administration

Individual technique will determine the suspension quantity and specific procedure used. The following are suggested for Prepcat use as an aid for computed tomography.

Upper G.I. Opacification

The patient should drink 300 mL of ready-to-use Prepcat approximately 2 hours before the CT scan and an additional 300 mL approximately 15 minutes prior to examination.

If rapid upper gastrointestinal tract transit is desired, administer the product chilled.

Total Bowel Opacification

The patient should drink 300 mL the night preceding the examination, 300 mL two hours prior to the examination and 300 mL approximately 15 minutes prior to examination.

Rectal/Colon Administration

Rectally administered Prepcat should be at room temperature to body temperature. Transfer the desired quantity of ready-to-use Prepcat into an enema administration unit, such as Empty Enema Kit. Close the slide clamp. Lubricate the tip and carefully insert. If Empty Enema Kit is used, invert and squeeze the red ball into the bag. Return the bag to upright and with the patient in the left lateral position, open the slide clamp to administer the suspension. Coating of the entire colon may be achieved by rotating the patient 360°. For increased patient comfort, excess suspension may be drained back into the enema bag.

Pediatric Use

The quantity of suspension used and the barium sulfate concentration will depend upon patient size, technique used and clinical need.

For single patient use only. Properly discard unused portion.

How is Prepcat Suspension Supplied

Catalog No. 169415. NDC 68240-126-45. 450 mL (15 fl. oz.) bottle; twenty-four (24) bottles with straws per case.

Store at 25°C (77°F); excursions permitted to 15º to 30ºC (59 to 86ºF). Protect from freezing.

Shake well before using.

DIN: 00794260

Distributed in Canada by:

tyco Healthcare

Pointe-Claire, QC, Canada H9R 5H8

Establishment License # 100689-A

Made in Mexico

Manufactured by:

Mallinckrodt Inc.

St. Louis, MO 63042 USA

www.Mallinckrodt.com

MID 1304678 Rev 04/2009

CT CONTRAST

G.I. EXAMS

Pre-mixed

Ready-to-use

Flavored

tyco

Healthcare

Mallinckrodt

Package Label - Principal Display Panel - 450 mL Bottle

L A F A Y E T T E

PREPCAT™

BARIUM SULFATE SUSPENSION

Catalog No. 169415

O3™ ANTIMICROBIAL TECHNOLOGY

CT CONTRAST / G.I. EXAMS

Rx only

450 mL

PREPCAT

Barium Sulfate Suspension USP

NDC 68240-126-45

Catalog No. 169415

A strawberry flavored, ready-to-use, 1.5% w/w (w/v), barium sulfate USP suspension for use as an aid for computed tomography of the gastrointestinal tract.

Contents: Barium sulfate USP, sorbitol, simethicone, suspending agent, potassium sorbate, flavoring, citric acid, saccharin sodium and water.

Contraindications: Do not use in patients with suspected gastrointestinal tract perforation or known hypersensitivity to barium sulfate formulations.

Dosage and Administration: See package insert for complete instructions.

For single patient use only. Properly discard unused portion.

Shake well before using.

Storage: Store at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F). Protect from freezing.

Net Contents: 450 mL (15 fl. oz.)

DIN: 00794260

Distributed in Canada by:

tyco Healthcare

Pointe-Claire, QC, Canada H9R 5H8

Establishment License # 100689-A

Made in Mexico

Manufactured by:

Mallinckrodt Inc.

St. Louis, MO 63042 USA

www.Mallinckrodt.com

MID 1170010

Rev 04/2009

tyco

Healthcare

Mallinckrodt

PREPCAT
barium sulfate suspension

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	NDC Product Code (Source)	68240-126
Route of Administration	ORAL, RECTAL	DEA Schedule

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BARIUM SULFATE (BARIUM CATION)	BARIUM SULFATE	150 mg in 1 mL

Inactive Ingredients
Ingredient Name	Strength
SACCHARIN SODIUM
SODIUM HYPOCHLORITE
POTASSIUM SORBATE
HYDROGEN PEROXIDE
SORBITOL
CITRIC ACID MONOHYDRATE
WATER
XANTHAN GUM

Product Characteristics
Color		Score
Shape		Size
Flavor	STRAWBERRY	Imprint Code
Contains

Packaging
#	NDC	Package Description	Multilevel Packaging
1	68240-126-45	24 BOTTLE In 1 CASE	contains a BOTTLE, PLASTIC
1		450 mL In 1 BOTTLE, PLASTIC	This package is contained within the CASE (68240-126-45)

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved other		12/01/2009

Labeler - Mallinckrodt Inc. (810407189)

Establishment
Name	Address	ID/FEI	Operations
Mallinckrodt Medical, S.A. de C.V.		810407189	analysis, manufacture

Revised: 06/2009Mallinckrodt Inc.

More Prepcat Suspension resources

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

Compare Prepcat Suspension with other medications

Computed Tomography