Visine Eye Drops

Pronunciation: teh-trah-high-DRAHZ-ah-leen
Generic Name: Tetrahydrozoline
Brand Name: Examples include Altazine Moisture Relief and Visine

Visine Eye Drops are used for:

Relieving redness due to minor eye irritation.

Visine Eye Drops are a decongestant. It works by constricting swollen blood vessels in the eye, which reduces redness. Irritants cause blood vessels to swell.

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

Do NOT use Visine Eye Drops if:

• you are allergic to any ingredient in Visine Eye Drops


• you are taking furazolidone or have taken a monoamine oxidase (MAO) inhibitor (eg, phenelzine) within the last 14 days

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

Before using Visine Eye Drops:

Some medical conditions may interact with Visine Eye Drops. 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 narrow-angle glaucoma, an overactive thyroid, or high blood pressure

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

• Furazolidone and MAO inhibitors (eg, phenelzine) because side effects, such as headache, high blood pressure, and elevated body temperature, may occur


• Tricyclic antidepressants (eg, amitriptyline) because they may decrease Visine Eye Drops's effectiveness


• Bromocriptine or catechol-O-methyltransferase (COMT) inhibitors (eg, tolcapone, St. John's wort) because their actions and side effects may be increased by Visine Eye Drops

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

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

• Visine Eye Drops are for use in the eye only. Avoid contact with mucous membranes.


• If you wear contact lenses, remove them before using Visine Eye Drops.


• To use Visine Eye Drops, wash your hands. Tilt your head back. Using your index finger, pull the lower eyelid away from the eye to form a pouch. Drop the medicine into the pouch and gently close your eyes. Immediately use your finger to apply pressure to the inside corner of the eye and continue to apply pressure for 1 to 2 minutes after using the medicine. Do not blink.


• Remove excess medicine around your eye with a clean tissue, being careful not to touch your eye.


• Wash your hands to remove any medicine that may be on them. To prevent germs from contaminating your medicine, do not touch the applicator tip to any surface, including your eye.


• Keep the container tightly closed.


• Do not use Visine Eye Drops if solution changes color or becomes cloudy.


• If you miss a dose of Visine Eye Drops and you are using it regularly, use it as soon as possible. If it is much more than 1 hour since your missed dose, skip the missed dose and go back to your regular dosing schedule. Do not use 2 doses at once.

Ask your health care provider any questions you may have about how to use Visine Eye Drops.

Important safety information:

• Visine Eye Drops may cause blurred vision. Do not drive, operate machinery, or do anything else that could be dangerous unless you can see clearly.


• Do not use Visine Eye Drops for longer than 3 days without checking with your doctor.


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


• Using too much of Visine Eye Drops may increase redness of the eye.


• Visine Eye Drops are not recommended for use in CHILDREN younger than 6 years of age. Safety and effectiveness in this age group have not been confirmed.


• PREGNANCY and BREAST-FEEDING: If you become pregnant, discuss with your doctor the benefits and risks of using Visine Eye Drops during pregnancy. It is unknown if Visine Eye Drops are excreted in breast milk. If you are or will be breast-feeding while you are using Visine Eye Drops, check with your doctor or pharmacist to discuss the risks to your baby.

Possible side effects of Visine Eye Drops:

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:

Blurring, tearing, or stinging of the eye; dilation of pupils.

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

Severe allergic reactions (rash; hives; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); change in vision; continued redness or irritation of the eye; eye pain; headache.

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: Visine 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. Visine Eye Drops may be harmful if swallowed, especially in children.

Proper storage of Visine Eye Drops:

Store Visine Eye Drops at room temperature, between 59 and 86 degrees F (15 and 30 degrees C). Store away from heat, moisture, and light. Do not store in the bathroom. Keep Visine Eye Drops out of the reach of children and away from pets.

General information:

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


• Visine Eye Drops 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 Visine Eye Drops. If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.

Issue Date: February 1, 2012

Database Edition 12.1.1.002

Copyright © 2012 Wolters Kluwer Health, Inc.

More Visine resources

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

Compare Visine with other medications

• Eye Dryness/Redness

Varicella Zoster Immune Globulin

Class: Serums
ATC Class: J06BB03
VA Class: IM100
Brands: VariZIG

Introduction

Specific immune globulin (hyperimmune globulin).^{13 31} Varicella zoster immune globulin (VZIG) contains antibody to varicella zoster virus (VZV) prepared from plasma of donors with high titers of anti-VZV and is used to provide temporary passive immunity to VZV.^{13 41 49}

Uses for Varicella Zoster Immune Globulin

Postexposure Prophylaxis of Varicella Zoster Virus (VZV)

Postexposure prophylaxis to prevent or reduce severity of varicella (chickenpox) in pregnant women who do not have evidence of varicella immunity and were exposed to VZV within the last 4 days (96 hours).^{31 39 41 49 50 51 52}

Postexposure prophylaxis to prevent or reduce severity of varicella in neonates† whose mothers had signs and symptoms of varicella at the time of delivery (i.e., from 5 days before to 2 days after delivery).^{31 41 52} Such neonates are at risk of severe, potentially fatal varicella and should receive VZIG regardless of whether the mother received VZIG.^{31 41 51}

Postexposure prophylaxis to prevent or reduce severity of varicella in certain premature neonates† exposed to VZV during neonatal period.^{31 41 52} VZIG recommended for exposed premature neonates born at <28 weeks of gestation or with birthweight ≤1 kg, regardless of maternal history of varicella or varicella vaccination.^{31 41 52} Also recommended for exposed premature neonates born at ≥28 weeks of gestation if mother does not have evidence of varicella immunity.^{31 41 52}

Postexposure prophylaxis to prevent or reduce severity of varicella in immunocompromised children† or immunocompromised adults† who do not have evidence of varicella immunity and were exposed to VZV within the last 4 days (96 hours).^{31 39 41 52} This includes those with primary or acquired immunodeficiency disorders (including HIV infection), neoplastic disease, and those receiving immunosuppressive therapy.^{31 39 41} Individuals receiving immune globulin IV (IGIV) replacement therapy (≥400 mg/kg once monthly) are likely to be protected from VZV and probably do not require VZIG if last IGIV dose was administered ≤3 weeks before exposure.^{31 39 41}

VZIG provides temporary passive immunity and may prevent or reduce severity of VZV infection if administered within 4 days (96 hours) after exposure.^{31 41 49 52} May not be effective if administered >4 days (>96 hours) after exposure.^{41 49 52}

Active immunization with varicella vaccine preferred for postexposure prophylaxis in most immunocompetent individuals exposed to VZV who have not previously received age-appropriate vaccination with varicella vaccine and do not have evidence of varicella immunity.^{31 41 51 52}

Passive immunization with VZIG recommended for postexposure prophylaxis in individuals without evidence of varicella immunity if varicella vaccine is contraindicated or cannot be used and exposed individual is at risk for severe disease and complications (e.g., pregnant women, neonates, immunocompromised individuals).^{31 52}

VZIG not indicated for postexposure prophylaxis in healthy term infants exposed postnatally or in susceptible immunocompetent children, adolescents, or adults.³¹

When varicella vaccine is contraindicated or cannot be used and VZIG is unavailable (cannot be obtained within 96 hours of exposure), consider use of IGIV as an alternative since it contains anti-VZV.^{31 41 52}

Decisions to administer VZIG should be made on an individual basis and depend on whether patient lacks evidence of varicella immunity, exposure is likely to result in infection, and patient is at greater risk for varicella complications than the general population.^{31 41}

ACIP states that evidence of varicella immunity includes documentation of age-appropriate vaccination against varicella, laboratory evidence of immunity or laboratory confirmation of prior varicella, birth in the US before 1980 (except pregnant women, immunocompromised individuals, health-care personnel), diagnosis or verification of history of varicella by health-care provider, or diagnosis or verification of history of herpes zoster (shingles, zoster) by health-care provider.⁴¹ Individuals without such evidence should be considered susceptible.⁴¹

ACIP states that exposures likely to result in varicella in individuals without evidence of immunity are those that involve direct contact (i.e., face-to-face contact with an infectious person while indoors).⁴¹ Some experts suggest use of VZIG be considered if duration of close contact was >5 minutes, others define close contact as >1 hour.^{31 41} Those with continuous exposure to household members with varicella or disseminated ter are at greatest risk for infection.⁴¹ For hospital contacts, substantial exposure consists of sharing the same hospital room or direct face-to-face contact with an infectious person.⁴¹

VZIG has not been shown to be useful for treatment of clinical varicella or herpes zoster or for preventing disseminated zoster and is not recommended for such use.^{31 41}

Varicella Zoster Immune Globulin Dosage and Administration

Administration

Administer by IV or IM injection.⁴⁹

Monitor patient for adverse effects for at least 20 minutes after administration of VZIG.⁴⁹ (See Cautions.)

Do not mix with any other drug or solution.⁴⁹

Do not administer concomitantly with varicella vaccine.^{31 41 52} (See Specific Drugs and Laboratory Tests under Interactions.)

IV Administration

If a preexisting catheter must be used for the IV injection, flush line with 0.9% sodium chloride for injection prior to giving VZIG dose.⁴⁹

Reconstitution

Add 2.5 mL of diluent supplied by the manufacturer to the vial of lyophilized powder using a suitable syringe and needle.⁴⁹ Inject diluent slowly at an angle so that liquid is directed onto the wall of the vial.⁴⁹ Wet pellet by gently tilting and inverting vial.⁴⁹ Avoid frothing.⁴⁹ Gently swirl upright vial until pellet dissolves; do not shake.⁴⁹

Inspect visually for particulate matter and discoloration.⁴⁹ Solution should be clear or slightly opalescent; do not use if it is cloudy or contains deposits.⁴⁹

Reconstituted solution for IV administration contains 50 units/mL.⁴⁹

Reconstituted solution may be stored for up to 12 hours at 2–8°C.⁴⁹ (See Storage under Stability.) Allow solution to warm to room or body temperature before use.⁴⁹

Rate of Administration

Inject directly into a vein over 3–5 minutes.⁴⁹

IM Administration

Administer IM into deltoid muscle or anterolateral aspect of upper thigh.⁴⁹

Because of risk of injection-associated injury to the sciatic nerve, use gluteal region only when necessary and use only the upper, outer quadrant.⁴⁹

Reconstitution

Add 1.25 mL of diluent supplied by the manufacturer to the vial of lyophilized powder using a suitable syringe and needle.⁴⁹ Inject diluent slowly at an angle so that liquid is directed onto the wall of the vial.⁴⁹ Wet pellet by gently tilting and inverting vial.⁴⁹ Avoid frothing.⁴⁹ Gently swirl upright vial until pellet dissolves; do not shake.⁴⁹

Inspect visually for particulate matter and discoloration.⁴⁹ Solution should be clear or slightly opalescent; do not use if it is cloudy or contains deposits.⁴⁹

Reconstituted solution for IM administration contains 100 units/mL.⁴⁹

Reconstituted solution may be stored for up to 12 hours at 2–8°C.⁴⁹ (See Storage under Stability.) Allow solution to warm to room or body temperature before use.⁴⁹

Dosage

Pediatric Patients

Postexposure Prophylaxis of Varicella Zoster Virus (VZV)

Neonates (Including Premature Neonates)†

IV or IM

Single dose of 125 units/10 kg of body weight (up to 625 units).^{41 52}

Give dose within 4 days (96 hours) of exposure to VZV, preferably as soon as possible.^{31 41 49 52}

Susceptible Immunocompromised Children or Adolescents <18 Years of Age†

IV or IM

Single dose of 125 units/10 kg of body weight (up to 625 units).^{41 52}

Give dose within 4 days (96 hours) of exposure to VZV, preferably as soon as possible.^{31 41 49 52}

Adults

Postexposure Prophylaxis of Varicella Zoster Virus (VZV)

Susceptible Pregnant Women

IV or IM

Single dose of 125 units/10 kg of body weight (up to 625 units).^{41 49 52}

Give dose within 96 hours of exposure to VZV, preferably as soon as possible.^{31 41 49 52}

Susceptible Immunocompromised Adults†

IV or IM

Single dose of 125 units/10 kg of body weight (up to 625 units).^{41 52}

Give dose within 4 days (96 hours) of exposure to VZV, preferably as soon as possible.^{31 41 49 52}

Prescribing Limits

Pediatric Patients

Minimum dose is 125 units; maximum dose is 625 units.^{41 49}

Adults

Minimum dose is 125 units; maximum dose is 625 units.^{41 49}

Special Populations

Hepatic Impairment

No specific dosage recommendations.⁴⁹

Renal Impairment

No specific dosage recommendations.⁴⁹

Geriatric Patients

No specific dosage recommendations.⁴⁹ (See Geriatric Use under Cautions.)

Cautions for Varicella Zoster Immune Globulin

Contraindications

• 
  

  Hypersensitivity to VZIG or any ingredient in the formulation or component of the container.⁴⁹

  
  


• 
  

  History of anaphylactic or other severe systemic reactions to immune globulins.⁴⁹

  
  


• 
  

  Known immunity to VZV (i.e., previous varicella infection or age-appropriate vaccination with varicella vaccine).⁴⁹

  
  


• 
  

  IgA deficiency.⁴⁹ (See Selective IgA Deficiency under Cautions.)

  
  

Warnings/Precautions

Warnings

Risk of Transmissible Agents in Plasma-derived Preparations

Because VZIG is prepared from pooled human plasma, it 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 Creutzfeldt-Jakob disease (CJD) or variant CJD (vCJD).^{49 55}

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.⁴⁹

The manufacturing process for VZIG includes a solvent/detergent inactivation process and a filtering procedure to remove both enveloped and non-enveloped viruses.⁴⁹

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 VZIG only when a benefit is expected.⁴⁹

Any infection believed to have been transmitted by VZIG should be reported to the manufacturer at 800-768-2304.⁴⁹

Sensitivity Reactions

Hypersensitivity Reactions

Although not reported to date with VZIG,⁴⁹ anaphylaxis reported rarely following administration of other human immune globulins.⁵⁶

Weigh potential benefit of VZIG against potential for hypersensitivity reactions.⁴⁹

Epinephrine and other appropriate therapy should be readily available in case anaphylaxis occurs.⁴⁹

If hypotension or a hypersensitivity reaction (e.g., anaphylaxis) occurs, immediately discontinue VZIG and institute appropriate therapy (e.g., epinephrine) as indicated.⁴⁹

Selective IgA Deficiency

Individuals with IgA deficiency may have antibodies to IgA or may develop such antibodies following administration of VZIG preparations containing IgA.⁴⁹ Hypersensitivity (including anaphylactic reactions) may occur.⁴⁹

VariZIG contains trace amounts (<40 mcg/mL) of IgA.⁴⁹ As little as 15 mcg of IgA per mL of blood product may elicit an anaphylactic reaction in individuals with IgA deficiency.⁴⁹

General Precautions

Administration Precautions

Administer under supervision of a qualified health professional experienced in use of passive immunizing agents and management of pregnant women exposed to VZV.⁴⁹

Administer in clinical settings with adequate diagnostic and treatment facilities readily available to manage therapy and any possible complications.⁴⁹

Monitor patient for adverse effects for at least 20 minutes after administration of VZIG.⁴⁹

Thrombotic Events

Thrombotic events reported in patients receiving IGIV.⁴⁹ Patients at risk for such events include those with a history of atherosclerosis, multiple cardiovascular risk factors, advanced age, impaired cardiac output, hypercoagulable disorders, prolonged periods of immobilization, and/or known or suspected hyperviscosity.⁴⁹

Potential for thrombotic events is significantly lower with VZIG than with IGIV because of differences in amount of protein infused, volume infused, and relative health of the patient population receiving VZIG.⁴⁹

Although risk for thrombotic events with VZIG appears to be extremely low, use caution in those at risk for hyperviscosity (e.g., those with cryoglobulins, fasting chylomicronemia/markedly high triglycerides, monoclonal gammopathies).⁴⁹ IM administration of VZIG may be preferred instead of IV administration in such patients since thrombotic events have only been reported following IV administration of immune globulins.⁴⁹

Renal Effects

Renal dysfunction, acute renal failure, osmotic nephrosis, proximal tubular nephropathy, and death reported in patients receiving IGIV.⁴⁹ Patients at increased risk for IGIV-associated acute renal failure include those receiving known nephrotoxic drugs and those with any degree of preexisting renal insufficiency or with diabetes mellitus, volume depletion, sepsis, or paraproteinemia.⁴⁹

Adverse renal effects occur most frequently with IGIV preparations stabilized with sucrose and given in dosages providing ≥400 mg of sucrose daily.⁴⁹ VZIG does not contain sucrose as a stabilizer and contains lower amounts of protein than IGIV preparations.⁴⁹

Transfusion-related Acute Lung Injury

Transfusion-related acute lung injury (noncardiogenic pulmonary edema) reported in patients receiving IGIV.⁴⁹ Typically occurs within 1–6 hours after the IGIV infusion and is characterized by severe respiratory distress, pulmonary edema, hypoxemia, normal left ventricular function, and fever.⁴⁹

The potential for severe respiratory complications is significantly lower with VZIG than with IGIV because of differences in amount of protein infused, volume infused, and relative health of the patient population receiving VZIG.⁴⁹

Although risk for severe respiratory complications with VZIG appears to be extremely low, use caution in those with preexisting respiratory conditions.⁴⁹ IM administration of VZIG may be preferred instead of IV administration in such patients since severe respiratory adverse events have only been reported following IV administration of immune globulins.⁴⁹

Monitor for adverse pulmonary reactions.⁴⁹ If transfusion-related acute lung injury is suspected, perform appropriate tests for the presence of antineutrophil antibodies in both the product and patient serum.⁴⁹ Manage with oxygen therapy with adequate ventilatory support.⁴⁹

Individuals with Altered Immunocompetence

May be administered to individuals immunosuppressed as the result of disease or immunosuppressive therapy.^{39 41}

Immunocompromised individuals without evidence of varicella immunity are at high risk of severe or disseminated varicella and generally should receive VZIG for postexposure prophylaxis.^{31 41 51}

VZIG is recommended for postexposure prophylaxis in individuals without evidence of varicella immunity who are immunosuppressed because they are receiving corticosteroid therapy (prednisone or equivalent) in a dosage ≥2 mg/kg daily or ≥20 mg daily.⁴¹

VZIG is recommended for postexposure prophylaxis in HIV-infected children and adults (including pregnant women) without evidence of varicella immunity.^{31 39}

Not indicated for individuals who previously received age-appropriate varicella vaccination and subsequently became immunocompromised as the result of disease or immunosuppressive therapy later in life.⁴¹

Bone marrow transplant recipients should be considered susceptible to varicella, regardless of previous history of varicella or varicella vaccination in themselves or in their donors.⁴¹ However, those who develop varicella or herpes zoster after transplantation should be considered immune to varicella.⁴¹

Limitations of Effectiveness

May prevent or modify varicella if given within 4 days (96 hours) of exposure.⁴¹ Immune globulins not effective once disease is established.³¹

Use of VZIG for postexposure prophylaxis in pregnant women exposed to VZV may prevent or reduce severity of varicella in the woman, but such prophylaxis in the mother does not prevent fetal infection.^{31 41}

In some patients, VZIG may not prevent varicella and may prolong the incubation period from 10–21 days to ≥28 days.^{31 41} Closely observe patient for signs and symptoms of varicella for 28 days after exposure; immediately initiate antiviral therapy if signs or symptoms of varicella occur.⁴¹

Passive immunization with VZIG only provides short-term protection against VZV (see Duration of Immunity under Cautions).^{31 41} Unless varicella vaccine is contraindicated, patients who receive VZIG for postexposure prophylaxis should receive active immunization with the vaccine ≥5 months after VZIG.^{31 41} (See Specific Drugs and Laboratory Tests under Interactions.) Varicella vaccine is not needed if the patient developed varicella despite administration of VZIG.^{31 41}

Duration of Immunity

Duration of protection against VZV following administration of VZIG unknown.⁴¹ Single dose of VZIG provides passive immunity to VZV that should last about 3 weeks.⁴¹

Administer a second dose of VZIG if another exposure to VZV occurs in a susceptible individual at high risk who cannot receive varicella vaccine.⁴¹

Serologic Testing

After a dose of VZIG, passively-acquired anti-VZV may interfere with serologic tests used to determine immunity to VZV for ≥3 months.⁴⁹ (See Specific Drugs and Laboratory Tests under Interactions.)

Because some patients who receive VZIG for postexposure prophylaxis may have asymptomatic varicella infections, some experts recommend follow-up serologic testing ≥2 months after VZIG to determine immune status in case a subsequent exposure occurs.³¹ Other experts suggest that serologic tests are unreliable in immunocompromised individuals and asymptomatic infections in such individuals may not confer lasting protection; these experts recommend use of VZIG in immunocompromised individuals after subsequent VZV exposure regardless of serologic test results.³¹

When serologic testing is performed to determine immune status after natural varicella, positive antibody results are reliable but negative antibody results may not be reliable.³¹

Specific Populations

Pregnancy

Category C.⁴⁹

A decision to use VZIG for postexposure prophylaxis of VZV in a pregnant woman should be made on an individual basis taking into consideration the woman's health status, type of exposure, and likelihood of previously unrecognized varicella infection.⁴⁹

Because of potential risks to the neonate from exposure to VZV infection, pregnancy is not considered a contraindication to use of VZIG when indicated.⁴⁹

ACIP states there are no known risks associated with use of immune globulins for passive immunization in pregnant women.¹³

Lactation

Not known whether VZIG is distributed into milk; use caution.⁴⁹

Pediatric Use

Safety and efficacy not established in children <18 years of age.⁴⁹

Although specific studies evaluating currently available VZIG in pediatric patients not available, previously available preparations of VZIG have been effective in at-risk pediatric populations and similar efficacy is likely.⁴⁹

ACIP and AAP recommend use of VZIG in neonates† whose mothers had signs and symptoms of varicella at the time of delivery (i.e., from 5 days before to 2 days after delivery) and in certain premature infants†.^{41 52} ACIP and AAP also recommend use of VZIG in susceptible immunocompromised children† exposed to VZV.^{31 39 41 52} (See Postexposure Prophylaxis of Varicella Zoster Virus [VZV] under Uses.)

Geriatric Use

Safety and efficacy not established in geriatric individuals >65 years of age.⁴⁹ Data not available to date regarding use in this age group.⁴⁹

Common Adverse Effects

Pain at injection site, headache, rash, chills, fever, vomiting, nausea, arthralgia, low back pain, allergic reactions.⁴⁹

Interactions for Varicella Zoster Immune Globulin

Live Vaccines

Antibodies present in immune globulins, including VZIG, may interfere with the immune response to certain live virus vaccines (e.g., measles virus vaccine live, mumps virus vaccine live, rotavirus vaccine live oral, rubella virus vaccine live, varicella virus vaccine live); these vaccines should not be administered simultaneously with or for specified intervals before or after administration of VZIG.^{13 31 41 49 52} (See Specific Drugs and Laboratory Tests 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).¹³

Inactivated Vaccines and Toxoids

Immune globulins, including VZIG, 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 VZIG.^{13 31} Neonates who received VZIG at birth can receive age-appropriate inactivated vaccines according to the usually recommend childhood immunization schedule.³¹

Specific Drugs and Laboratory Tests

Drug	Interaction	Comments
Immunosuppressive agents (e.g., alkylating agents, antimetabolites, corticosteroids, radiation)	Individuals receiving immunosuppressive therapy who are exposed to VZV and do not have evidence of varicella immunity are at high risk of severe or disseminated varicella31 41 51 Corticosteroid therapy (prednisone or equivalent) in a dosage ≥2 mg/kg daily or ≥20 mg daily given for ≥2 weeks is considered immunosuppressive41	Recommendations for use of immune globulins in patients receiving immunosuppressive agents are the same as those for patients not receiving such agents13
Influenza vaccine	Intranasal live Influenza vaccine : No evidence that immune globulin preparations interfere with the immune response to the vaccine13 Parenteral inactivated influenza vaccine: Interference with the immune response to this inactivated vaccine not expected13	Intranasal live influenza vaccine or parenteral inactivated influenza vaccine may be given simultaneously with or at any interval before or after VZIG13
Measles, mumps, and rubella vaccine (MMR)	VZIG may interfere with the immune response to measles vaccine live and rubella vaccine live; the effect of immune globulin on the immune response to mumps vaccine live is unknown49	MMR (or its individual components) should not be administered simultaneously with VZIG13 Manufacturer of VZIG states live virus vaccines should be deferred for approximately 3 months after VZIG and those who receive VZIG shortly after a live virus vaccine should be revaccinated 3 months after the VZIG dose49 ACIP states MMR (or its individual components) should be deferred until 8 months after immune globulin given for postexposure prophylaxis; if given simultaneously with or within 14 days before a dose of immune globulin, the MMR dose (or its individual components) should be repeated ≥8 months after the immune globulin unless serologic testing is feasible and indicates a response to the vaccine was attained13 49
Rotavirus vaccine	Safety and efficacy data not available regarding use of rotavirus vaccine in infants who have received an immune globulin within 42 days13 54	If possible, defer dose of rotavirus vaccine until 42 days (6 weeks) after the immune globulin; use a shorter interval if the 42-day deferral would result in the first dose of rotavirus vaccine being scheduled at ≥13 weeks of age13
Tests, Coombs'	Passively-acquired anti-VZV from VZIG persists for ≥6 weeks after a single dose; these antibodies may cause false-positive results in the Coombs' test49
Tests, VZV immunity	Passively-acquired anti-VZV from VZIG may result in false-positives in serologic tests used to determine immunity to VZV49	Serologic tests to determine VZV immunity should not be performed until ≥3 months after administration of VZIG49
Typhoid vaccine	Oral live typhoid vaccine (Vivotif): No evidence that immune globulin preparations interfere with the immune response to the vaccine13 Parenteral inactivated typhoid vaccine (Typhim Vi): Interference with the immune response to this inactivated vaccine not expected13	Oral live typhoid vaccine (Vivotif): May be given simultaneously with or at any time before or after VZIG13 Parenteral inactivated typhoid vaccine (Typhim Vi): May be given simultaneously with (using different syringes and injection sites) or at any time before or after VZIG13
Varicella vaccine	Passively acquired anti-VZV from VZIG may interfere with the active immune response to varicella vaccine live13 41 49 52	Varicella vaccine live should not be administered simultaneously with and should be deferred until 5 months after VZIG31 41 52 If a dose of varicella vaccine live is given simultaneously with or within 14 days before a dose of VZIG, the vaccine dose should be repeated ≥5 months after the VZIG dose unless serologic testing is feasible and indicates a response to the vaccine was attained13 41 49 52
Yellow fever vaccine	No evidence that immune globulin preparations interfere with the immune response to yellow fever virus vaccine live13 31	Yellow fever vaccine may be given simultaneously with VZIG (using different syringes and different injection sites) or at any time before or after VZIG13 31

Varicella Zoster Immune Globulin Pharmacokinetics

Absorption

Bioavailability

Following IV administration of VZIG, peak serum concentrations of immune globulin are attained in <3 hours.⁴⁹

Following IM administration of VZIG, bioavailability is expected to be almost 100%.⁴⁹ Anti-VZV antibodies are detected within 2–3 days and peak within 3–7 days.⁴⁹

Although concentrations of passively-acquired antibody are higher and achieved more quickly following IV administration than IM administration,⁵⁰ levels of circulating antibodies over time are expected to be similar with both routes.⁴⁹

Distribution

Extent

Following IV administration of VZIG, anti-VZV is expected to be quickly distributed between plasma and extravascular spaces.⁴⁹

Not known whether VZIG is distributed into milk.⁴⁹

Elimination

Metabolism

Immune globulins are metabolized in the reticuloendothelial system.⁴⁹

Half-life

Half-life of hyperimmune globulins generally is about 18–24 days following IV administration and 24–30 days following IM administration.⁴⁹ Half-life is expected to show interindividual variation.⁴⁹

Anti-VZV antibodies persist for ≥6 weeks after a single dose of VZIG.⁴⁹ Protection against VZV may last approximately 3 weeks.⁴¹

Stability

Storage

Parenteral

Powder, for Injection

2–8°C.⁴⁹ Do not freeze.⁴⁹

After reconstitution, store for up to 12 hours at 2–8°C.⁴⁹

Does not contain thimerosal or any other preservatives.⁴⁹

ActionsActions

• 
  

  Currently available VZIG is a lyophilized preparation of purified IgG fraction containing anti-VZV prepared from plasma of healthy adults with high titers of anti-VZV.⁴⁹

  
  


• 
  

  Potency of VZIG is expressed in international units by comparison to the WHO international anti-VZV immune globulin reference preparation.⁴⁹

  
  


• 
  

  Primary VZV infection results in varicella (chickenpox); reactivation of infection results in herpes zoster.⁵¹

  
  


• 
  

  Varicella usually is self-limited in otherwise healthy children.^{31 41 51} In neonates or immunocompromised children or adults, varicella is associated with a high risk of severe or disseminated disease (e.g., pneumonia, encephalitis, multiple organ system involvement) and death.^{6 9 31 41 51}

  
  


• 
  

  Maternal-fetal transmission of VZV can cause congenital varicella syndrome resulting in low birthweight, cutaneous scarring, limb hypoplasia, microcephaly, cortical atrophy, chorioretinitis, cataracts, and other anomalies and may result in fetal death.^{31 41 51} Congenital varicella syndrome occurs most frequently in infants born to women who had varicella at about 13–20 weeks of gestation.^{31 41 51} Severe neonatal infection, including fatalities, can occur when varicella develops in neonates born to women who had onset of varicella from 5 days before to 2 days after delivery.^{31 41 51}

  
  


• 
  

  Varicella is highly contagious; the secondary infection rate is 85% in healthy, susceptible individuals exposed through household contact.⁴¹ Individuals usually are contagious from 1–2 days before rash onset through 5–6 days after rash onset.⁴¹ Immunocompromised individuals may be contagious for a longer period of time, presumably because their immune system is depressed allowing viral replication to persist.⁴¹

  
  


• 
  

  In susceptible pregnant women exposed to varicella, postexposure prophylaxis with VZIG decreases the rate of infection to about 30%.^{41 49} Although use of VZIG in susceptible pregnant women may prevent or ameliorate clinical disease in the mother, such prophylaxis in the mother does not appear to prevent viremia, fetal infection, congenital varicella syndrome, or varicella in her neonate.^{31 41}

  
  


• 
  

  When VZIG postexposure prophylaxis is used in neonates exposed to VZV in utero within 7 days of delivery, the rate of infection is not substantially decreased compared with neonates who do not receive postexposure prophylaxis; however the incidence of severe neonatal varicella and fatal outcomes is substantially decreased in those who do become infected.⁴¹

  
  


• 
  

  In susceptible immunocompromised children exposed to VZV, postexposure prophylaxis with VZIG decreases, but does not eliminate, the risk of infection (attack rate following such prophylaxis is decreased to ≤60%); however, VZIG substantially decreases the incidence of severe varicella in those who do become infected.⁴¹

  
  

Advice to Patients

• 
  

  Advise patient and/or patient's parent or guardian of the risks and benefits of VZIG.⁴⁹

  
  


• 
  

  Advise patient and/or patient's parent or guardian that VZIG is prepared from pooled human plasma.⁴⁹ Although improved donor screening and viral-inactivating and purification procedures used in manufacture of plasma-derived preparations have reduced the risk of pathogen transmission, VZIG 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.^{49 55}

  
  


• 
  

  Advise patients that allergic or anaphylactic reactions to VZIG are rare, but these reactions can occur in individuals with a history of allergy to blood products or with IgA deficiency.⁴⁹ Importance of informing clinician of any prior allergic reactions to blood products or prior diagnosis of IgA deficiency.⁴⁹

  
  


• 
  

  Because VZIG may impair the immune response to certain live virus vaccines (e.g., measles vaccine, mumps vaccine, rotavirus vaccine, rubella vaccine, varicella vaccine),^{13 31 41 49 52} importance of informing clinician of any recent vaccinations.⁴⁹

  
  


• 
  

  Importance of women informing clinicians if they are or plan to become pregnant or plan to breast-feed.⁴⁹

  
  


• 
  

  Importance of informing patients of other important precautionary information.⁴⁹ (See Cautions.)

  
  

Preparations

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

VZIG is no longer commercially available in the US, but is available under an IND expanded access protocol.⁵² Contact the distributor, FFF Enterprises, at 800-843-7477 for information regarding the IND protocol and how to obtain VZIG.^{52 53}

Varicella Zoster Immune Globulin

Routes	Dosage Forms	Strengths	Brand Names	Manufacturer
Parenteral	For injection	125 units of varicella zoster antibody per vial	VariZIG (solvent/detergent treated; with glycine 0.1M; preservative-free; available in single-dose vials with diluent)	Cangrene

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 June 2008. 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

1. Massachusetts Public Health Biologic Laboratories. Varicella-zoster immune globulin (human) prescribing information. Boston, MA. 2000 Apr.

2. Zaia JA, Levin MJ, Wright GG et al. A practical method for preparation of varicella-zoster immune globulin. J Infect Dis. 1978; 137:601-4. [PubMed 207788]

3. Centers for Disease Control. Varicella-zoster immune globulin—United States. MMWR Morb Mortal Wkly Rep. 1981; 30:15-23. [IDIS 126301] [PubMed 6789088]

5. Oxman MN. Varicella. In: Braude AI, Davis CE, Fierer J, eds. Medical microbiology and infectious diseases. Philadelphia: WB Saunders Company; 1981:1652-63.

6. Feldman S, Hughes WT, Daniel CB. Varicella in children with cancer: seventy-seven cases. Pediatrics. 1975; 56:388-97. [IDIS 57341] [PubMed 1088828]

7. Brunell PA. Varicella-zoster virus. In: Mandell GL, Douglas RG Jr, Bennett JE, eds. Principles and practices of infectious diseases. New York: John Wiley & Sons; 1979:1295-1306.

8. Winsnes R. Efficacy of zoster immunoglobulin in prophylaxis of varicella in high risk patients. Drugs. 1979; 17:507.

9. Dolin R, Reichman RC, Mazur MH et al. Herpes zoster-varicella infections in immunos

Visine

Generic Name: tetrahydrozoline ophthalmic (TE tra hye DROZ oh leen)

Brand Names: Altazine, Geneye Extra, Geneyes, Opti-Clear, Optigene 3, Redness Relief, Redness Relief Original, Visine, Visine Maximum Redness Relief, Vision Clear

What is Visine (tetrahydrozoline ophthalmic)?

Tetrahydrozoline ophthalmic narrows the blood vessels (veins and arteries) in your eyes.

Tetrahydrozoline ophthalmic (for the eyes) is used to relieve redness, burning, irritation, and dryness of the eyes caused by wind, sun, and other minor irritants.

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

What is the most important information I should know about Visine (tetrahydrozoline ophthalmic)?

Do not use tetrahydrozoline ophthalmic without medical advice if you have glaucoma. Do not use this medication while wearing contact lenses. Tetrahydrozoline ophthalmic may contain a preservative that can discolor soft contact lenses. Wait at least 15 minutes after using tetrahydrozoline ophthalmic before putting your contact lenses in. Do not allow the tip of the dropper to touch any surface, including your eyes or hands. If the dropper becomes contaminated it could cause an infection in your eye, which can lead to vision loss or serious damage to the eye. Do not use tetrahydrozoline ophthalmic more often than recommended, or use it for longer than 48 to 72 hours without medical advice. Long-term use of this medication may damage the blood vessels in the eyes. Call your doctor if your symptoms do not improve or if they get worse.

What should I discuss with my healthcare provider before using Visine (tetrahydrozoline ophthalmic)?

Do not use tetrahydrozoline ophthalmic without medical advice if you have glaucoma.

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

• 
  

  heart disease or coronary artery disease;

  
  


• 
  

  high blood pressure;

  
  


• 
  

  diabetes; or

  
  


• 
  

  a thyroid disorder.

  
  

FDA pregnancy category C. It is not known whether tetrahydrozoline ophthalmic 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 tetrahydrozoline nasal 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 give this medication to a child without a doctor's advice.

How should I use Visine (tetrahydrozoline ophthalmic)?

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.

Do not use tetrahydrozoline ophthalmic more often than recommended, or use it for longer than 48 to 72 hours without medical advice. Long-term use of this medication may damage the blood vessels in the eyes. Call your doctor if your symptoms do not improve or if they get worse. Do not use this medication while you are wearing contact lenses. This medication may contain a preservative that can be absorbed by soft contact lenses. Wait at least 15 minutes after using tetrahydrozoline before putting your contact lenses in. Wash your hands before and after using the eye drops.

To apply the eye drops:

• 
  

  Tilt your head back slightly and pull down your lower eyelid to create a small pocket. Hold the dropper above the eye with the tip down. Look up and away from the dropper as you squeeze out a drop, then close your eye.

  
  


• 
  

  Gently press your finger to the inside corner of the eye (near your nose) for about 1 minute to keep the liquid from draining into your tear duct.

  
  


• 
  

  Do not allow the dropper tip to touch any surface, including the eyes or hands. If the dropper becomes contaminated it could cause an infection in your eye, which can lead to vision loss or serious damage to the eye.

  
  

Do not allow the tip of the dropper to touch any surface, including your eyes or hands. If the dropper becomes contaminated it could cause an infection in your eye, which can lead to vision loss or serious damage to the eye.

Do not use the eye drops if the liquid has changed colors or has particles in it.

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

What happens if I miss a dose?

Since tetrahydrozoline ophthalmic is used on an as needed basis, you are not likely to miss a dose.

What happens if I overdose?

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

What should I avoid while using Visine (tetrahydrozoline ophthalmic)?

Do not use other eye medications during treatment with tetrahydrozoline ophthalmic unless your doctor tells you to.

Visine (tetrahydrozoline ophthalmic) 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 tetrahydrozoline ophthalmic and call your doctor at once if you have a serious side effect such as:

• 
  

  severe burning, stinging, swelling, or other irritation after using the eye drops;

  
  


• 
  

  fast or pounding heartbeats; or

  
  


• 
  

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

  
  

Less serious side effects may include:

• 
  

  burning, stinging, pain, or increased redness of the eye;

  
  


• 
  

  tearing or blurred vision;

  
  


• 
  

  nausea;

  
  


• 
  

  nervousness, dizziness, drowsiness;

  
  


• 
  

  sleep problems (insomnia); or

  
  


• 
  

  headache.

  
  

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 Visine (tetrahydrozoline ophthalmic)?

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

• 
  

  an MAO inhibitor such as furazolidone (Furoxone), isocarboxazid (Marplan), phenelzine (Nardil), rasagiline (Azilect), selegiline (Eldepryl, Emsam, Zelapar), or tranylcypromine (Parnate); or

  
  


• 
  

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

  
  

This list is not complete and other drugs may interact with tetrahydrozoline ophthalmic. 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 Visine resources

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

• Visine Eye Drops MedFacts Consumer Leaflet (Wolters Kluwer)


• Clarinex Monograph (AHFS DI)

Compare Visine with other medications

• Eye Dryness/Redness

Where can I get more information?

• Your pharmacist can provide more information about tetrahydrozoline ophthalmic.

See also: Visine side effects (in more detail)

Visken

pindolol

Dosage Form: Tablets

T1999-39

89003701

   Visken®

   (pindolol)

   tablets, USP

   Rx only

Visken Description

Visken® (pindolol), a synthetic beta-adrenergic receptor blocking agent with intrinsic sympathomimetic activity is 1-(Indol-4-yloxy)-3-(isopropylamino)-2-propanol.

Its structural formula is:

Pindolol is a white to off-white odorless powder soluble in organic solvents and aqueous acids. Visken® (pindolol) is intended for oral administration.

5 mg and 10 mg Tablets

Active Ingredient: pindolol

Inactive Ingredients: colloidal silicon dioxide, magnesium stearate, microcrystalline cellulose, and pregelatinized starch.

Visken - Clinical Pharmacology

Visken® (pindolol) is a non-selective beta-adrenergic antagonist (beta-blocker) which possesses intrinsic sympathomimetic activity (ISA) in therapeutic dosage ranges but does not possess quinidine-like membrane stabilizing activity.

PHARMACODYNAMICS

In standard pharmacologic tests in man and animals, Visken® (pindolol) attenuates increases in heart rate, systolic blood pressure, and cardiac output resulting from exercise and isoproterenol administration, thus confirming its beta-blocking properties. The ISA or partial agonist activity of Visken® (pindolol) is mediated directly at the adrenergic receptor sites and may be blocked by other beta-blockers. In catecholamine-depleted animal experiments, ISA is manifested as an increase in the inotropic and chronotropic activity of the myocardium. In man, ISA is manifested by a smaller reduction in the resting heart rate (4-8 beats/min) than is seen with drugs lacking ISA. There is also a smaller reduction in resting cardiac output. The clinical significance of this observation has not been evaluated and there is no evidence, or reason to believe, that exercise cardiac output is less affected by Visken® (pindolol).

Visken® (pindolol) has been shown in controlled, double-blind clinical studies to be an effective antihypertensive agent when used as monotherapy, or when added to therapy with thiazide-type diuretics. Divided dosages in the range of 10-60 mg daily have been shown to be effective. As monotherapy, Visken® (pindolol) is as effective as propranolol, α-methyldopa, hydrochlorothiazide, and chlorthalidone in reducing systolic and diastolic blood pressure. The effect on blood pressure is not orthostatic, i.e. Visken® (pindolol) was equally effective in reducing the supine and standing blood pressure.

In open, long-term studies up to 4 years, no evidence of diminution of the blood pressure-lowering response was observed.

An average 3-pound increase in body weight has been noted in patients treated with Visken® (pindolol) alone, a larger increase than was observed with propranolol or placebo. The weight gain appeared unrelated to blood pressure response and was not associated with an increased risk of heart failure, although edema was more common than in control patients. Visken® (pindolol) does not have a consistent effect on plasma renin activity.

The mechanism of the antihypertensive effects of beta-blocking agents has not been established, but several mechanisms have been postulated: 1) an effect on the central nervous system resulting in a reduced sympathetic outflow to the periphery, 2) competitive antagonism of catecholamines at peripheral (especially cardiac) adrenergic receptor sites, leading to decreased cardiac output, 3) an inhibition of renin release. These mechanisms appear less likely for pindolol than other beta-blockers in view of the modest effect on resting cardiac output and renin.

Beta-blockade therapy is useful when it is necessary to suppress the effects of beta-adrenergic agonists in order to achieve therapeutic goals. However, in certain clinical situations, (e.g., cardiac failure, heart block, bronchospasm), the preservation of an adequate sympathetic tone may be necessary to maintain vital functions. Although a beta-antagonist with ISA such as Visken® (pindolol) does not eliminate sympathetic tone entirely, there is no controlled evidence that it is safer than other beta-blockers in such conditions as heart failure, heart block, or bronchospasm or is less likely to cause those conditions. In single dose studies of the effects of beta-blockers on FEV1, Visken® (pindolol) was indistinguishable from other non-cardioselective agents in its reduction of FEV1, and its reduction in the effectiveness of an exogenous beta agonist.

Exacerbation of angina and, in some cases, myocardial infarction and ventricular dysrhythmias have been reported after abrupt discontinuation of therapy with beta-adrenergic blocking agents in patients with coronary artery disease. Abrupt withdrawal of these agents in patients without coronary artery disease has resulted in transient symptoms, including tremulousness, sweating, palpitation, headache, and malaise. Several mechanisms have been proposed to explain these phenomena, among them increased sensitivity to catecholamines because of increased numbers of beta receptors.

PHARMACOKINETICS AND METABOLISM

Visken® (pindolol) is rapidly and reproducibly absorbed (greater than 95%), achieving peak plasma concentrations within 1 hour of drug administration. Visken® (pindolol) has no significant first-pass effect. The blood concentrations are proportional in a linear manner to the administered dose in the range of 5-20 mg. Upon repeated administration to the same subject, variation is minimal. After a single dose, intersubject variation for peak plasma concentrations was about 4fold (e.g., 45-167 ng/mL for a 20 mg dose). Upon multiple dosing, intersubject variation decreased to 2-2.5 fold. Visken® (pindolol) is only 40% bound to plasma proteins and is evenly distributed between plasma and red cells. The volume of distribution in healthy subjects is about 2 L/kg.

Visken® (pindolol) undergoes extensive metabolism in animals and man. In man, 35%-40% is excreted unchanged in the urine and 60%-65% is metabolized primarily to hydroxy-metabolites which are excreted as glucuronides and ethereal sulfates. The polar metabolites are excreted with a half-life of approximately 8 hours and thus multiple dosing therapy (q.8H) results in a less than 50% accumulation in plasma. About 6%-9% of an administered intravenous dose is excreted by the bile into the feces.

The disposition of Visken® (pindolol) after oral administration is monophasic with a half-life in healthy subjects or hypertensive patients with normal renal function of approximately 3-4 hours. Following t.i.d. administration (q.8H), no significant accumulation of Visken® (pindolol) is observed.

In elderly hypertensive patients with normal renal function, the half-life of Visken® (pindolol) is more variable, averaging about 7 hours, but with values as high as 15 hours.

In hypertensive patients with renal diseases, the half-life is within the range expected for healthy subjects. However, a significant decrease (50%) in volume of distribution (VD) is observed in uremic patients and VD appears to be directly correlated to creatinine clearance. Therefore, renal drug clearance is significantly reduced in uremic patients, resulting in a significant decrease in urinary excretion of unchanged drug. Uremic patients with a creatinine clearance of less than 20 mL/min generally excreted less than 15% of the administered dose unchanged in the urine.

In patients with histologically diagnosed cirrhosis of the liver, the elimination of Visken® (pindolol) was more variable in rate and generally significantly slower than in healthy subjects. The total body clearance of Visken® (pindolol) in cirrhotic patients ranged from about 50-300 mL/min and was directly correlated to antipyrine clearance. The half-life ranges from 2.5 hours to greater than 30 hours. These findings strongly suggest that caution should be exercised in dosage adjustments of Visken® (pindolol) in such patients.

The bioavailability of Visken® (pindolol) is not significantly affected by co-administration of food, hydralazine, hydrochlorothiazide or aspirin. Visken® (pindolol) has no effect on warfarin activity or the clinical effectiveness of digoxin, although small transient decreases in plasma digoxin concentrations were noted.

Indications and Usage for Visken

Visken® (pindolol) is indicated in the management of hypertension. It may be used alone or concomitantly with other antihypertensive agents, particularly with a thiazide-type diuretic.

Contraindications

Visken® (pindolol) is contraindicated in: 1) bronchial asthma; 2) overt cardiac failure; 3) cardiogenic shock; 4) second and third degree heart block; 5) severe bradycardia.

(See WARNINGS)

Warnings

Cardiac Failure

Sympathetic stimulation may be a vital component supporting circulatory function in patients with congestive heart failure, and its inhibition by beta-blockade may precipitate more severe failure. Although beta-blockers should be avoided in overt congestive heart failure, if necessary, Visken® (pindolol) can be used with caution in patients with a history of failure who are well-compensated, usually with digitalis and diuretics. Beta-adrenergic blocking agents do not abolish the inotropic action of digitalis on heart muscle.

In Patients Without History of Cardiac Failure

In patients with latent cardiac insufficiency, continued depression of the myocardium with beta-blocking agents over a period of time can in some cases lead to cardiac failure. At the first sign or symptom of impending cardiac failure, patients should be fully digitalized and/or be given a diuretic, and the response observed closely. If cardiac failure continues, despite adequate digitalization and diuretic, Visken® (pindolol) therapy should be withdrawn (gradually if possible).

Exacerbation of Ischemic Heart Disease Following Abrupt Withdrawal

Hypersensitivity to catecholamines has been observed in patients withdrawn from beta-blocker therapy; exacerbation of angina and, in some cases, myocardial infarction have occurred after abrupt discontinuation of such therapy. When discontinuing chronically administered Visken® (pindolol), particularly in patients with ischemic heart disease, the dosage should be gradually reduced over a period of 1-2 weeks and the patient should be carefully monitored. If angina markedly worsens or acute coronary insufficiency develops, Visken® (pindolol) administration should be reinstituted promptly, at least temporarily, and other measures appropriate for the management of unstable angina should be taken. Patients should be warned against interruption or discontinuation of therapy without the physician’s advice. Because coronary artery disease is common and may be unrecognized, it may be prudent not to discontinue Visken® (pindolol) therapy abruptly even in patients treated only for hypertension.

Nonallergic Bronchospasm (e.g., chronic bronchitis, emphysema) - Patients with Bronchospastic Diseases Should in General Not Receive Beta-Blockers

Visken® (pindolol) should be administered with caution since it may block bronchodilation produced by endogenous or exogenous catecholamine stimulation of beta2 receptors.

Major Surgery

Because beta blockade impairs the ability of the heart to respond to reflex stimuli and may increase the risks of general anesthesia and surgical procedures, resulting in protracted hypotension or low cardiac output, it has generally been suggested that such therapy should be gradually withdrawn several days prior to surgery. Recognition of the increased sensitivity to catecholamines of patients recently withdrawn from beta-blocker therapy, however, has made this recommendation controversial. If possible, beta-blockers should be withdrawn well before surgery takes place. In the event of emergency surgery, the anesthesiologist should be informed that the patient is on beta-blocker therapy.

The effects of Visken® (pindolol) can be reversed by administration of beta-receptor agonists such as isoproterenol, dopamine, dobutamine, or levarterenol. Difficulty in restarting and maintaining the heart beat has also been reported with beta-adrenergic receptor blocking agents.

Diabetes and Hypoglycemia

Beta-adrenergic blockade may prevent the appearance of premonitory signs and symptoms (e.g., tachycardia and blood pressure changes) of acute hypoglycemia. This is especially important with labile diabetics. Beta-blockade also reduces the release of insulin in response to hyperglycemia; therefore, it may be necessary to adjust the dose of antidiabetic drugs.

Thyrotoxicosis

Beta-adrenergic blockade may mask certain clinical signs (e.g., tachycardia) of hyperthyroidism. Patients suspected of developing thyrotoxicosis should be managed carefully to avoid abrupt withdrawal of beta-blockade which might precipitate a thyroid crisis.

Precautions

Impaired Renal or Hepatic Function

Beta-blocking agents should be used with caution in patients with impaired hepatic or renal function. Poor renal function has only minor effects on Visken® (pindolol) clearance, but poor hepatic function may cause blood levels of Visken® (pindolol) to increase substantially.

Information for Patients

Patients, especially those with evidence of coronary artery insufficiency, should be warned against interruption or discontinuation of Visken® (pindolol) therapy without the physician’s advice. Although cardiac failure rarely occurs in properly selected patients, patients being treated with beta-adrenergic blocking agents should be advised to consult the physician at the first sign or symptom of impending failure.

Drug Interactions

Catecholamine-depleting drugs (e.g., reserpine) may have an additive effect when given with beta-blocking agents. Patients receiving Visken® (pindolol) plus a catecholamine-depleting agent should, therefore, be closely observed for evidence of hypotension and/or marked bradycardia which may produce vertigo, syncope, or postural hypotension.

Visken® (pindolol) has been used with a variety of antihypertensive agents, including hydrochlorothiazide, hydralazine, and guanethidine without unexpected adverse interactions.

Visken® (pindolol) has been shown to increase serum thioridazine levels when both drugs are co-administered. Visken® (pindolol) levels may also be increased with this combination.

Risk of Anaphylactic Reaction:

While taking beta blockers, patients with a history of severe anaphylactic reaction to a variety of allergens may be more reactive to repeated challenge, either accidental, diagnostic, or therapeutic. Such patients may be unresponsive to the usual doses of epinephrine used to treat allergic reaction.

Carcinogenesis, Mutagenesis, Impairment of Fertility

In chronic oral toxicologic studies (1-2 years) in mice, rats, and dogs, Visken® (pindolol) did not produce any significant toxic effects. In 2-year oral carcinogenicity studies in rats and mice in doses as high as 59 mg/kg/day and 124 mg/kg/day (50 and 100 times the maximum recommended human dose), respectively, Visken® (pindolol) did not produce any neoplastic, preneoplastic, or nonneoplastic pathologic lesions. In fertility and general reproductive performance studies in rats, Visken® (pindolol) caused no adverse effects at a dose of 10 mg/kg.

In the male fertility and general reproductive performance test in rats, definite toxicity characterized by mortality and decreased weight gain was observed in the group given 100 mg/kg/day. At 30 mg/kg/day, decreased mating was associated with testicular atrophy and/or decreased spermatogenesis. This response is not clearly drug related, however, as there was no dose response relationship within this experiment and no similar effect on testes of rats administered Visken® (pindolol) as a dietary admixture for 104 weeks. There appeared to be an increase in prenatal mortality in males given 100 mg/kg but development of offspring was not impaired.

In females administered Visken® (pindolol) prior to mating through day 21 of lactation, mating behavior was decreased at 100 mg/kg and 30 mg/kg. At these dosages there also was increased mortality of offspring. Prenatal mortality was increased at 10 mg/kg but there was not a clear dose response relationship in this experiment. There was an increased resorption rate at 100 mg/kg observed in females necropsied on the 15th day of gestation.

Pregnancy

Category B:

Studies in rats and rabbits exceeding 100 times the maximum recommended human doses, revealed no embryotoxicity or teratogenicity. Since there are no adequate and well-controlled studies in pregnant women, and since animal reproduction studies are not always predictive of human response, Visken® (pindolol), as with any drug, should be employed during pregnancy only if the potential benefit justifies the potential risk to the fetus.

Nursing Mothers

Since Visken® (pindolol) is secreted in human milk, nursing should not be undertaken by mothers receiving the drug.

Pediatric Use

Safety and effectiveness in pediatric patients have not been established.

CLINICAL LABORATORY

Minor persistent elevations in serum transaminases (SGOT, SGPT) have been noted in 7% of patients during Visken® (pindolol) administration, but progressive elevations were not observed. These elevations were not associated with any other abnormalities that would suggest hepatic impairment, such as decreased serum albumin and total proteins. During more than a decade of worldwide marketing, there have been no reports in the medical literature of overt hepatic injury. Alkaline phosphatase, lactic acid dehydrogenase (LDH), and uric acid are also elevated on rare occasions. The significance of these findings is unknown.

Adverse Reactions

Most adverse reactions have been mild. The incidences listed in the following table are derived from 12-week comparative double-blind, parallel design trials in hypertensive patients given Visken® (pindolol) as monotherapy, given various active control drugs as monotherapy, or given placebo. Data for Visken® (pindolol) and the positive controls were pooled from several trials because no striking differences were seen in the individual studies, with 1 exception. When considering all adverse reactions reported, the frequency of edema was noticeably higher in positive control trials [16% Visken® (pindolol) vs. 9% positive control] than in placebo controlled trials [6%Visken® (pindolol) vs. 3% placebo]. The table includes adverse reactions either volunteered or elicited, and at least possibly drug related, which were reported in greater than 2% of Visken® (pindolol) patients and other selected important reactions.

Adverse Reactions Which Were Volunteered or Elicited(and at least possibly drug related)

Body System/ Adverse Reactions	Visken®  (pindolol) (N=322) %	Active Controls* (N=188) %	Placebo (N=78) %
Central Nervous System
Bizarre or Many Dreams	5	0	6
Dizziness	9	11	1
Fatigue	8	4	4
Hallucinations	<1	0	0
Insomnia	10	3	10
Nervousness	7	3	5
Weakness	4	2	1
Autonomic Nervous System
Paresthesia	3	1	6
Cardiovascular
Dyspnea	5	4	6
Edema	6	3	1
Heart Failure	<1	<1	0
Palpitations	<1	1	0
Musculoskeletal
Chest Pain	3	1	3
Joint Pain	7	4	4
Muscle Cramps	3	1	0
Muscle Pain	10	9	8
Gastrointestinal
Abdominal Discomfort	4	4	5
Nausea	5	2	1
Skin
Pruritus	1	<1	0
Rash	<1	<1	1

*Active Controls: Patients received either propranolol, α-methyldopa or a diuretic (hydrochlorothiazide or chlorthalidone).

The following selected (potentially important) adverse reactions were seen in 2% or fewer patients and their relationship to Visken® (pindolol) is uncertain. CENTRAL NERVOUS SYSTEM: anxiety, lethargy; AUTONOMIC NERVOUS SYSTEM: visual disturbances, hyperhidrosis; CARDIOVASCULAR: bradycardia, claudication, cold extremities, heart block, hypotension, syncope, tachycardia, weight gain; GASTROINTESTINAL: diarrhea, vomiting; RESPIRATORY: wheezing; UROGENITAL: impotence, pollakiuria; MISCELLANEOUS: eye discomfort or burning eyes.

POTENTIAL ADVERSE EFFECTS

In addition, other adverse effects not aforementioned have been reported with other beta-adrenergic blocking agents and should be considered potential adverse effects of Visken® (pindolol).

Central Nervous System: Reversible mental depression progressing to catatonia; an acute reversible syndrome characterized by disorientation for time and place, short-term memory loss, emotional lability, slightly clouded sensorium, and decreased performance on neuropsychometrics.

Cardiovascular: Intensification of AV block. (See CONTRAINDICATIONS)

Allergic: Erythematous rash; fever combined with aching and sore throat; laryngospasm; respiratory distress.

Hematologic: Agranulocytosis; thrombocytopenic and nonthrombocytopenic purpura.

Gastrointestinal: Mesenteric arterial thrombosis; ischemic colitis.

Miscellaneous: Reversible alopecia; Peyronie’s disease.

The oculomucocutaneous syndrome associated with the beta-blocker practolol has not been reported with Visken® (pindolol) during investigational use and extensive foreign experience amounting to over 4 million patient-years.

Overdosage

No specific information on emergency treatment of overdosage is available. Therefore, on the basis of the pharmacologic actions of Visken® (pindolol), the following general measures should be employed as appropriate in addition to gastric lavage:

Excessive Bradycardia: administer atropine; if there is no response to vagal blockade, administer isoproterenol cautiously.

Cardiac Failure: digitalize the patient and/or administer diuretic. It has been reported that glucagon may be useful in this situation.

Hypotension: administer vasopressors, e.g., epinephrine or levarterenol, with serial monitoring of blood pressure. (There is evidence that epinephrine may be the drug of choice.)

Bronchospasm: administer a beta2 stimulating agent such as isoproterenol and/or a theophylline derivative.

A case of an acute overdosage has been reported with an intake of 500 mg of Visken® (pindolol) by a hypertensive patient. Blood pressure increased and heart rate was ≥80 beats/min. Recovery was uneventful. In another case, 250 mg of Visken® (pindolol) was taken with 150 mg diazepam and 50 mg nitrazepam, producing coma and hypotension. The patient recovered in 24 hours.

Visken Dosage and Administration

The dosage of Visken® (pindolol) should be individualized. The recommended initial dose of Visken® (pindolol) is 5 mg b.i.d. alone or in combination with other antihypertensive agents. An antihypertensive response usually occurs within the first week of treatment. Maximal response, however, may take as long as or occasionally longer than 2 weeks. If a satisfactory reduction in blood pressure does not occur within 3-4 weeks, the dose may be adjusted in increments of 10 mg/day at these intervals up to a maximum of 60 mg/day.

How is Visken Supplied

Visken® (pindolol) tablets, USP

White, uncoated, heart-shaped tablets; 5 mg and 10 mg, packages of 100. 5 mg tablets engraved “Visken 5’’ on one side, and embossed “V’’ on other side (NDC 0078-0111-05). 10 mg tablets engraved “Visken 10’’ on one side, and embossed “V’’ on other side (NDC 0078-0073-05).

Store and Dispense

Below 86°F (30°C); tight, light-resistant container.

Manufactured by:

Novartis Pharmaceuticals Canada Inc.

Dorval (Quebec) Canada H9R 4P5

Distributed by:

Novartis Pharmaceuticals Corporation

East Hanover, New Jersey 07936

REV: NOVEMBER 1998                         T1999-39

89003701

2162-25-99A

©1998 Novartis

Visken  pindolol  tablet

Product Information Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 0078-0111 Route of Administration ORAL DEA Schedule

INGREDIENTS Name (Active Moiety) Type Strength pindolol (pindolol) Active 5 MILLIGRAM  In 1 TABLET colloidal silicon dioxide Inactive   magnesium stearate Inactive   microcrystalline cellulose Inactive   pregelatinized starch Inactive

Product Characteristics Color WHITE Score no score Shape FREEFORM Size 7mm Flavor Imprint Code Visken;5;V Contains          Coating false Symbol false

Packaging # NDC Package Description Multilevel Packaging 1 0078-0111-05 100 TABLET In 1 PACKAGE None

Visken  pindolol  tablet

Product Information Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 0078-0073 Route of Administration ORAL DEA Schedule

INGREDIENTS Name (Active Moiety) Type Strength pindolol (pindolol) Active 10 MILLIGRAM  In 1 TABLET colloidal silicon dioxide Inactive   magnesium stearate Inactive   microcrystalline cellulose Inactive   pregelatinized starch Inactive

Product Characteristics Color WHITE Score no score Shape FREEFORM Size 8mm Flavor Imprint Code Visken;10;V Contains          Coating false Symbol false

Packaging # NDC Package Description Multilevel Packaging 1 0078-0073-05 100 TABLET In 1 PACKAGE None

Revised: 10/2006Novartis Pharmaceuticals Corporation

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