immune globulin (intravenous) IGIV

Generic Name: immune globulin (intravenous) (IGIV) (im MYOON GLOB yoo lin)

Brand names: Carimune, Flebogamma, Gammagard (obsolete), Gammagard S/D, Gammaplex, Gammar-P I.V., Gamunex, Octagam, Polygam S/D, Privigen, Sandoglobulin, ...show all 20 brand names.Venoglobulin-S 5%, Venoglobulin-S 10%, Gammar I.V., Iveegam, Gamimune N 5%, Gamimune N 10%, Panglobulin, Iveegam En, Panglobulin NF

What is immune globulin intravenous (IVIG)?

Immune globulin intravenous is a sterilized solution made from human plasma. It contains the antibodies to help your body protect itself against infection from various diseases.

Immune globulin is used to treat primary immune deficiency, and to reduce the risk of infection in individuals with poorly functioning immune systems such as those with chronic lymphocytic leukemia (CLL). IGIV is also used to increase platelets (blood clotting cells) in people with idiopathic thrombocytopenic purpura (ITP) and to prevent aneurysm caused by a weakening of the main artery in the heart associated with Kawasaki syndrome.

Immune globulin is also used to treat chronic inflammatory demyelinating polyneuropathy (CIDP), a debilitating nerve disorder that causes muscle weakness and can affect daily activities.

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

What is the most important information I should know about immune globulin?

Immune globulin can harm your kidneys, and this effect is increased when you also use certain other medicines harmful to the kidneys. Before using immune globulin, tell your doctor about all other medications you use. Many other drugs (including some over-the-counter medicines) can be harmful to the kidneys.

Before using immune globulin intravenous, tell your doctor if you have kidney disease, diabetes (especially if you use insulin), a history of stroke or blood clot, heart disease, high blood pressure, a condition called paraproteinemia, or if you are over 65 years old.

To be sure this medicine is helping your condition and is not causing harmful effects, your blood will need to be tested often. Your kidney function may also need to be tested. Visit your doctor regularly.

This medication can cause unusual results with certain blood glucose tests. Tell any doctor who treats you that you are using immune globulin.

Immune globulin is made from human plasma (part of the blood) which may contain viruses and other infectious agents. Donated plasma is tested and treated to reduce the risk of it containing infectious agents, but there is still a small possibility it could transmit disease. Talk with your doctor about the risks and benefits of using this medication.

What should I discuss with my health care provider before using immune globulin?

You should not use this medication if you have ever had an allergic reaction to an immune globulin or if you have immune globulin A (IgA) deficiency with antibody to IgA.

To make sure you can safely use immune globulin, tell your doctor if you have any of these other conditions:

• 
  

  kidney disease;

  
  


• 
  

  diabetes (especially if you use insulin);

  
  


• 
  

  a history of stroke or blood clot;

  
  


• 
  

  heart disease or high blood pressure;

  
  


• 
  

  a condition called paraproteinemia; or

  
  


• 
  

  if you are over 65 years old.

  
  

FDA pregnancy category C. It is not known whether immune globulin 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 if immune globulin 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.

Immune globulin is made from human plasma (part of the blood) which may contain viruses and other infectious agents. Donated plasma is tested and treated to reduce the risk of it containing infectious agents, but there is still a small possibility it could transmit disease. Talk with your doctor about the risks and benefits of using this medication.

How is immune globulin intravenous given?

Immune globulin intravenous is injected into a vein through an IV. You may be shown how to use an IV at home. Do not self-inject this medicine if you do not fully understand how to give the injection and properly dispose of used needles, IV tubing, and other items used to inject the medicine.

IVIG should not be injected into a muscle or under the skin.

Do not use the medication if it has changed colors or has particles in it. Call your doctor for a new prescription. Throw away any unused medicine that is left over after injecting your dose.

Use each disposable needle only one time. Throw away used needles in a puncture-proof container (ask your pharmacist where you can get one and how to dispose of it). Keep this container out of the reach of children and pets.

IVIG is usually given every 3 to 4 weeks. Your dosing schedule may be different. Follow your doctor's instructions.

Your doctor may occasionally change your dose to make sure you get the best results.

To be sure this medicine is helping your condition and is not causing harmful effects, your blood will need to be tested often. Your kidney function may also need to be tested. Visit your doctor regularly.

This medication can cause unusual results with certain blood glucose tests. Tell any doctor who treats you that you are using immune globulin.

Some brands of immune globulin should be stored in a refrigerator, while others can be kept at room temperature. Follow the directions on your prescription label or ask your pharmacist if you have questions about how to store the medication. Do not allow the medicine to freeze.

What happens if I miss a dose?

Call your doctor for instructions if you miss a dose of this medication.

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 immune globulin?

Do not receive a "live" vaccine while using IVIG. The vaccine may not work as well during this time, and may not fully protect you from disease. Live vaccines include measles, mumps, rubella (MMR), oral polio, typhoid, chickenpox (varicella), BCG (Bacillus Calmette and Guérin), and nasal flu vaccine.

Immune globulin 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. Call your doctor at once if you have a serious side effect such as:

• 
  

  urinating less than usual or not at all;

  
  


• 
  

  drowsiness, confusion, mood changes, increased thirst, loss of appetite, nausea and vomiting;

  
  


• 
  

  swelling, weight gain, feeling short of breath;

  
  


• 
  

  wheezing, chest tightness;

  
  


• 
  

  feeling like you might pass out;

  
  


• 
  

  fever with headache, neck stiffness, chills, increased sensitivity to light, purple spots on the skin, and/or seizure (convulsions); or

  
  


• 
  

  pale or yellowed skin, dark colored urine, fever, confusion or weakness.

  
  

Less serious side effects may include:

• 
  

  mild headache;

  
  


• 
  

  dizziness;

  
  


• 
  

  tired feeling;

  
  


• 
  

  back pain, muscle cramps;

  
  


• 
  

  minor chest pain; or

  
  


• 
  

  flushing (warmth, redness, or tingly feeling).

  
  

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.

Immune globulin (intravenous) Dosing Information

Usual Adult Dose for Bone Marrow Transplantation:

20 years or older: 400 to 500 mg/kg/dose IV, given as an infusion, every week for 3 months, then once a month

Usual Adult Dose for Chronic Lymphocytic Leukemia:

400 mg/kg/dose IV, given as an infusion, every 3 weeks

Usual Adult Dose for Idiopathic (Immune) Thrombocytopenic Purpura:

Initial dose: 400 to 1000 mg/kg/day IV, given as an infusion, for 2 to 5 days
Maintenance: 400 to 1000 mg/kg/dose IV, given as an infusion, every 3 to 6 weeks based on clinical response and platelet count

Usual Adult Dose for Kawasaki Disease:

2000 mg/kg IV, given as an infusion, over 10 to 12 hours
The dose may need to be repeated if response is inadequate.

Usual Adult Dose for Primary Immunodeficiency Syndrome:

300 to 600 mg/kg/dose IV, given as an infusion, once every 3 to 4 weeks

Usual Adult Dose for Chronic Inflammatory Demyelinating Polyradiculoneuropathy:

Loading dose: 2 g/kg IV, given as an infusion, in divided doses over 2 to 4 consecutive days
Maintenance dose: 1 g/kg IV, given as an infusion, over 1 day or 0.5 g/kg IV infusion on 2 consecutive days, every 3 weeks

Usual Adult Dose for Polymyositis/Dermatomyositis:

Study (n=35)
1 g/kg/day IV, given as an infusion, for 2 consecutive days per month, for 4 to 6 months

Usual Pediatric Dose for Chronic Lymphocytic Leukemia:

400 mg/kg/dose IV, given as an infusion, every 3 to 4 weeks

Usual Pediatric Dose for HIV Infection:

400 mg/kg/dose every 2 to 4 weeks in those patients with hypogammaglobulinemia (IgG less than 400 mg/dL). Consider IGIV for HIV-infected children who have recurrent, serious bacterial infections during a 1 year period.

Usual Pediatric Dose for Idiopathic (Immune) Thrombocytopenic Purpura:

Initial dose: 400 to 1000 mg/kg/day IV, given as an infusion, for 2 to 5 consecutive days (total dose: 2 g/kg)

Maintenance: 400 to 1000 mg/kg/dose IV, given as an infusion, every 3 to 6 weeks based on clinical response and platelet count

Usual Pediatric Dose for Kawasaki Disease:

2000 mg/kg IV, given as a single dose, over 10 to 12 hours; should be used in combination with aspirin. If signs and symptoms persist greater than or equal to 36 hours after completion of the infusion, retreatment with a second 2000 mg/kg infusion should be considered.

Usual Pediatric Dose for Primary Immunodeficiency Syndrome:

Primary immunodeficiency disorders: Adjust dose/frequency based on desired IgG concentration and clinical response. Manufacturers dosing recommendations vary based on individual product used.
General dosing range: 200 to 800 mg/kg IV every 3 to 4 weeks; maintain a trough IgG concentration of 500 mg/dL.

Usual Pediatric Dose for Chronic Inflammatory Demyelinating Polyradiculoneuropathy:

400 mg/kg/day for 5 days once each month or 1 g/kg/day for 2 days once each month

What other drugs will affect immune globulin?

Immune globulin can harm your kidneys. This effect is increased when you also use other medicines harmful to the kidneys. You may need dose adjustments or special tests if you have recently used:

• 
  

  lithium (Lithobid);

  
  


• 
  

  methotrexate (Rheumatrex, Trexall);

  
  


• 
  

  pain or arthritis medicines such as aspirin (Anacin, Excedrin), acetaminophen (Tylenol), diclofenac (Cataflam, Voltaren), etodolac (Lodine), ibuprofen (Advil, Motrin), indomethacin (Indocin), meloxicam (Mobic), nabumetone (Relafen), naproxen (Aleve, Naprosyn), piroxicam (Feldene), and others;

  
  


• 
  

  medicines used to treat ulcerative colitis, such as mesalamine (Pentasa) or sulfasalazine (Azulfidine);

  
  


• 
  

  medicines used to prevent organ transplant rejection, such as cyclosporine (Gengraf, Neoral, Sandimmune), sirolimus (Rapamune) or tacrolimus (Prograf);

  
  


• 
  

  IV antibiotics such as amphotericin B (Fungizone, AmBisome, Amphotec, Abelcet), amikacin (Amikin), bacitracin (Baci-IM), capreomycin (Capastat), gentamicin (Garamycin), kanamycin (Kantrex), streptomycin, or vancomycin (Vancocin, Vancoled);

  
  


• 
  

  antiviral medicines such as adefovir (Hepsera), cidofovir (Vistide), or foscarnet (Foscavir); or

  
  


• 
  

  cancer medicine such as aldesleukin (Proleukin), carmustine (BiCNU, Gliadel), cisplatin (Platinol), ifosfamide (Ifex), oxaliplatin (Eloxatin), streptozocin (Zanosar), or tretinoin (Vesanoid).

  
  

This list is not complete and other drugs may interact with immune globulin. 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 immune globulin (intravenous) resources

• Immune globulin (intravenous) Dosage
• Immune globulin (intravenous) Use in Pregnancy & Breastfeeding
• Immune globulin (intravenous) Drug Interactions
• Immune globulin (intravenous) Support Group
• 5 Reviews for Immune globulin (intravenous) - Add your own review/rating

Compare immune globulin (intravenous) with other medications

• Autoimmune Neutropenia
• Bone Marrow Transplantation
• Chronic Inflammatory Demyelinating Polyradiculoneuropathy
• Chronic Lymphocytic Leukemia
• Evan's Syndrome
• HIV Infection
• Idiopathic Thrombocytopenic Purpura
• Kawasaki Disease
• Myasthenia Gravis
• Polymyositis/Dermatomyositis
• Primary Immunodeficiency Syndrome

Where can I get more information?

• Your pharmacist can provide more information about immune globulin intravenous.

iobenguane i 131 Intravenous

eye-oh-BEN-gwane I 131

Available Dosage Forms:

• Solution

Therapeutic Class: Diagnostic Agent, Radiopharmaceutical Imaging

Uses For iobenguane i 131

Radioiodinated iobenguane is a radiopharmaceutical. Radiopharmaceuticals are radioactive agents, which may be used to find and treat certain diseases or to study the function of the body's organs.

Radioiodinated iobenguane is used to treat certain kinds of cancer of the adrenal glands.

When very small doses of radioiodinated iobenguane are given, the radioactivity taken up by the adrenal gland helps find tumors of the adrenal glands. An image of the gland on film or on a computer screen can be provided to help with the diagnosis.

The information that follows applies only to the use of radioiodinated iobenguane in treating cancer of the adrenal gland.

Radioiodinated iobenguane is to be given only by or under the direct supervision of a doctor with specialized training in nuclear medicine.

Before Using iobenguane i 131

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 iobenguane i 131, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to iobenguane i 131 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

Children and adolescents are especially sensitive to the effects of radiation. This may increase the chance of side effects during and after treatment. Be sure you have discussed this with your doctor.

Geriatric

Radioiodinated iobenguane has been used in older people and has not been shown to cause different side effects or problems in older people than it does in younger adults.

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 iobenguane i 131, 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 iobenguane i 131 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.

• Labetalol

Interactions with Food/Tobacco/Alcohol

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

Other Medical Problems

The presence of other medical problems may affect the use of radioiodinated iobenguane. Make sure you tell your doctor if you have any other medical problems.

Proper Use of iobenguane i 131

Dosing

The dose of iobenguane i 131 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 iobenguane i 131. 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.

iobenguane i 131 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:

Rare

• Pale skin


• sore throat and fever


• unusual bleeding or bruising


• unusual tiredness or weakness

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

Less common or rare

• Flushing of skin


• nausea


• slight and temporary increase in blood pressure

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.

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 iobenguane i 131 Intravenous resources

• Iobenguane i 131 Intravenous Drug Interactions
• Iobenguane i 131 Intravenous Support Group
• 0 Reviews for Iobenguane i31 Intravenous - Add your own review/rating

Compare iobenguane i 131 Intravenous with other medications

• Diagnosis and Investigation

Urea Cream

Pronunciation: you-REE-ah
Generic Name: Urea
Brand Name: Examples include Carmol 40 and Keralac

Urea Cream is used for:

Promoting the healing of certain skin conditions (eg, hyperkeratotic conditions). It may also be used for certain other skin conditions (eg, corns; calluses; rough, dry skin) as determined by your doctor.

Urea Cream is a debriding agent. It works by helping the breakdown of dead skin and pus, which helps to loosen and shed hard and scaly skin.

Do NOT use Urea Cream if:

• you are allergic to any ingredient in Urea Cream

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

Before using Urea Cream:

Some medical conditions may interact with Urea Cream. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

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


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


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

Some MEDICINES MAY INTERACT with Urea Cream. Because little, if any, of Urea Cream is absorbed into the blood, the risk of it interacting with another medicine is low.

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

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

• Urea Cream is for external use only.


• Wash hands before and after using Urea Cream unless your hands are part of the treated area.


• Apply a small amount of Urea Cream to the affected area as directed by your doctor. If you get Urea Cream on any skin that is not part of the treated area, wash it off thoroughly.


• You may cover the affected area unless directed otherwise by your doctor.


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

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

Important safety information:

• Urea Cream is for external use only. Do not get it in the eyes, nose, or mouth. If you get Urea Cream in the eyes, rinse them immediately with a generous amount of cool water.


• Do not apply to broken or severely irritated skin.


• Do not exceed the recommended dose, use Urea Cream for longer than prescribed, or use Urea Cream for other skin conditions without checking with your doctor.


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

Possible side effects of Urea Cream:

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:

Mild skin irritation; temporary burning, stinging, or itching.

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); redness; severe or persistent irritation.

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.

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.

Proper storage of Urea Cream:

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

General information:

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


• Urea Cream is to be used only by the patient for whom it is prescribed. Do not share it with other people.


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


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

This information is a summary only. It does not contain all information about Urea Cream. 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 Urea resources

• Urea Use in Pregnancy & Breastfeeding
• Urea Support Group
• 9 Reviews for Urea - Add your own review/rating

Compare Urea with other medications

• Dermatological Disorders
• Dry Skin
• Pityriasis rubra pilaris

Lamisil AT 1% Spray

1. Name Of The Medicinal Product

Lamisil® AT 1% Spray

2. Qualitative And Quantitative Composition

10mg terbinafine hydrochloride per 1g spray solution

For excipients, see Section 6.1.

3. Pharmaceutical Form

Cutaneous spray, solution

4. Clinical Particulars

4.1 Therapeutic Indications

The treatment of tinea pedis (athlete's foot) and tinea cruris, (dhobie (jock) itch) caused by Trichophyton (e.g. T. rubrum, T. mentagrophytes, T. verrucosum, T. violaceum) and Epidermophyton floccosum.

4.2 Posology And Method Of Administration

Adults

Lamisil AT 1% Spray is applied once daily, for one week. Cleanse and dry the affected areas thoroughly before applying Lamisil AT 1% Spray from a distance of 5 to 10 cm. A sufficient amount of spray solution should be applied to wet the treatment area(s) thoroughly, and to cover the affected skin and surrounding area.

Duration and frequency of treatment:

Interdigital type tinea pedis, and tinea cruris: Once a day for one week.

Relief of clinical symptoms usually occurs within a few days. Irregular use or premature discontinuation of treatment carries the risk of recurrence. If there are no signs of improvement after two weeks, a physician should be consulted.

Use of Lamisil AT 1% Spray in the elderly

There is no evidence to suggest that elderly patients require different dosages or experience side effects different from those in younger patients.

Use of Lamisil AT 1% Spray in children

Not to be used in children under 16 years of age. Experience with Lamisil AT 1% Spray in children is limited and its use cannot, therefore, be recommended.

4.3 Contraindications

Known hypersensitivity to terbinafine or any of the excipients contained in the spray solution (see 6.1 List of excipients).

4.4 Special Warnings And Precautions For Use

Lamisil AT 1% Spray should be used with caution in patients with lesions where alcohol could be irritating.

Lamisil AT 1% Spray is for external use only. It may be irritating to the eyes. Lamisil AT 1% Spray should not be used on the face.

In case of accidental contact with the eyes, rinse eyes thoroughly with running water.

Avoid inhalation. In case of accidental inhalation, consult a physician if any symptoms develop or persist.

Lamisil AT 1% Spray should be kept out of the reach of children.

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

No drug interactions are known with Lamisil AT 1% Spray, however as a precaution it is recommended that other medicinal products are not applied on the treated areas.

4.6 Pregnancy And Lactation

Animal studies did not reveal any teratogenic or embryofoetotoxic potential of terbinafine. No cases of malformations in humans have been reported with Lamisil to date. However, since clinical experience in pregnant women is very limited, Lamisil AT 1% Spray should be used only if clearly indicated during pregnancy. Terbinafine is excreted in breast milk and therefore, mothers should not receive Lamisil AT 1% Spray whilst breast-feeding. Infants should also not be allowed to come into contact with any treated skin, including the breast.

4.7 Effects On Ability To Drive And Use Machines

Not applicable.

4.8 Undesirable Effects

Redness, itching or stinging may occur at the site of application; however, treatment rarely has to be discontinued for this reason. These harmless symptoms must be distinguished from allergic reactions such as pruritus, rash, bullous eruptions and hives, which are rare but require discontinuation.

4.9 Overdose

No case of overdosage has been reported with Lamisil AT 1% Spray. Should, however, Lamisil AT 1% Spray be inadvertently ingested, adverse effects similar to those observed with an overdosage of Lamisil Tablets (e.g. headache, nausea, epigastric pain and dizziness) are to be expected. The alcohol content (23.5%) of the spray solution has to be taken into account.

5. Pharmacological Properties

5.1 Pharmacodynamic Properties

Pharmacotherapeutic group: Antifungal for topical use (ATC code D01 A)

Terbinafine is an allylamine which has a broad spectrum of antifungal activity in fungal infections of the skin caused by dermatophytes such as Trichophyton (e.g. T. rubrum, T. mentagrophytes, T. verrucosum, T. violaceum), Microsporum canis and Epidermophyton floccosum. At low concentrations terbinafine is fungicidal against dermatophytes and moulds. The activity against yeasts is fungicidal (e.g. Pityrosporum orbiculare or Malassezia furfur) or fungistatic, depending on the species.

Terbinafine interferes specifically with fungal sterol biosynthesis at an early step. This leads to a deficiency in ergosterol and to an intracellular accumulation of squalene, resulting in fungal cell death. Terbinafine acts by inhibition of squalene epoxidase in the fungal cell membrane. The enzyme squalene epoxidase is not linked to the cytochrome P450 system. Terbinafine does not influence the metabolism of hormones or other drugs.

5.2 Pharmacokinetic Properties

Less than 5% of the dose is absorbed after topical application to humans; systemic exposure is thus very slight.

5.3 Preclinical Safety Data

In long-term studies (up to 1 year) in rats and dogs no marked toxic effects were seen in either species up to oral doses of about 100mg/kg a day. At high oral doses, the liver and possibly also the kidneys were identified as potential target organs.

In a two-year oral carcinogenicity study in mice, no neoplastic or other abnormal findings attributable to treatment were made up to doses of 130 (males) and 156 (females) mg/kg a day. In a two-year oral carcinogenicity study in rats at the highest dose level, 69mg/kg a day, an increased incidence of liver tumours was observed in males. The changes, which may be associated with peroxisome proliferation, have been shown to be species-specific since they were not seen in the carcinogenicity study in mice or in other studies in mice, dogs or monkeys.

During the studies of high dose oral terbinafine in monkeys, refractile irregularities were observed in the retina at the higher doses (non-toxic effect level was 50mg/kg). These irregularities were associated with the presence of a terbinafine metabolite in ocular tissue and disappeared after drug discontinuation. They were not associated with histological changes.

A standard battery of in vitro and in vivo genotoxicity tests revealed no evidence of a mutagenic or clastogenic potential for the drug.

No adverse effects on fertility or other reproduction parameters were observed in studies in rats or rabbits.

6. Pharmaceutical Particulars

6.1 List Of Excipients

Purified water

Ethanol (23.5% w/w)

Propylene glycol

Cetomacrogol 1000

6.2 Incompatibilities

Not applicable.

6.3 Shelf Life

3 years

6.4 Special Precautions For Storage

Do not store above 30°C. Do not refrigerate.

6.5 Nature And Contents Of Container

Lamisil AT 1% Spray is available as a white round HDPE bottle with a crimped mouth and spray pump in pack sizes of 15ml and 30ml.

6.6 Special Precautions For Disposal And Other Handling

See 4.2 Posology and method of administration and 4.4 Special warnings and precautions for use.

For manipulation of the spray pump the bottle can be held in the upright or inverted position.

When using Lamisil AT 1% Spray for the first time, the patient will need to depress the actuator a few times (usually up to 3 actuations) before the solution is dispensed.

7. Marketing Authorisation Holder

Novartis Consumer Health UK Ltd.

Wimblehurst Road

Horsham

RH12 5AB

UK

Trading as Novartis Consumer Health

8. Marketing Authorisation Number(S)

PL 00030/0147

9. Date Of First Authorisation/Renewal Of The Authorisation

7th December 2001

10. Date Of Revision Of The Text

27^th April 2009

Legal Category: GSL

Zephrex LA Sustained-Release Tablets

Pronunciation: gwye-FEN-ah-sin/sue-do-eh-FED-rin
Generic Name: Guaifenesin/Pseudoephedrine
Brand Name: Examples include Entex PSE and Zephrex LA

Zephrex LA Sustained-Release Tablets are used for:

Relieving congestion, cough, and throat and airway irritation due to colds, flu, or hay fever. It may also be used for other conditions as determined by your doctor.

Zephrex LA Sustained-Release Tablets are a decongestant and expectorant combination. It works by constricting blood vessels, reducing swelling in the nasal passages, and thinning and loosening mucus in the airway. This allows you to breathe more easily and makes coughs more productive.

Do NOT use Zephrex LA Sustained-Release Tablets if:

• you are allergic to any ingredient in Zephrex LA Sustained-Release Tablets


• you have severe high blood pressure, rapid heartbeat, or other severe heart problems (eg, heart blood vessel disease)


• you have taken furazolidone or 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 Zephrex LA Sustained-Release Tablets:

Some medical conditions may interact with Zephrex LA 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 a fast, slow, or irregular heartbeat


• if you have a history of adrenal gland problems (eg, tumor), heart problems, high blood pressure, diabetes, heart blood vessel problems, stroke, glaucoma, an enlarged prostate, seizures, or an overactive thyroid


• if you have chronic cough

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

• Beta-blockers (eg, propranolol), COMT inhibitors (eg, tolcapone), furazolidone, indomethacin, MAO inhibitors (eg, phenelzine), or tricyclic antidepressants (eg, amitriptyline) because they may increase the risk of Zephrex LA Sustained-Release Tablets's side effects


• Digoxin or droxidopa because the risk of irregular heartbeat or heart attack may be increased


• Bromocriptine because the risk of its side effects may be increased by Zephrex LA Sustained-Release Tablets


• Guanethidine, guanadrel, mecamylamine, methyldopa, or reserpine because their effectiveness may be decreased by Zephrex LA Sustained-Release Tablets

This may not be a complete list of all interactions that may occur. Ask your health care provider if Zephrex LA 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 Zephrex LA Sustained-Release Tablets:

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

• Take Zephrex LA Sustained-Release Tablets by mouth with or without food.


• Take Zephrex LA Sustained-Release Tablets with a full glass of water (8 oz/240 mL) unless your doctor tells you otherwise.


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

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

Important safety information:

• Zephrex LA Sustained-Release Tablets may cause dizziness. These effects may be worse if you take it with alcohol or certain medicines. Use Zephrex LA Sustained-Release Tablets with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.


• Do not take appetite suppressants while you are taking Zephrex LA Sustained-Release Tablets without checking with your doctor.


• Zephrex LA Sustained-Release Tablets has pseudoephedrine in it. Before you start any new medicine, check the label to see if it has pseudoephedrine in it too. If it does or if you are not sure, check with your doctor or pharmacist.


• Do NOT take more than the recommended dose or use for longer than prescribed without checking with your doctor.


• If your symptoms do not get better within 5 to 7 days or if they get worse, check with your doctor.


• Zephrex LA Sustained-Release Tablets may interfere with certain lab test results. Make sure that all of your doctors and lab personnel know that you are taking Zephrex LA Sustained-Release Tablets.


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


• Use Zephrex LA Sustained-Release Tablets with caution in the ELDERLY; they may be more sensitive to its effects.


• Caution is advised when using Zephrex LA Sustained-Release Tablets in CHILDREN; they may be more sensitive to its effects.


• PREGNANCY and BREAST-FEEDING: If you become pregnant while taking Zephrex LA Sustained-Release Tablets, contact your doctor. You will need to discuss the benefits and risks of using Zephrex LA Sustained-Release Tablets while pregnant. It is not known if Zephrex LA Sustained-Release Tablets are found in breast milk. Do not breast-feed while taking Zephrex LA Sustained-Release Tablets.

Possible side effects of Zephrex LA 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:

Dizziness; excitability; headache; nausea; nervousness or anxiety; trouble sleeping; weakness.

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); difficulty urinating; fast or irregular heartbeat; hallucinations; seizures; severe dizziness, lightheadedness, or headache; tremor.

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: Zephrex LA 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 blurred vision; confusion; hallucinations; seizures; severe dizziness, lightheadedness, or headache; severe drowsiness; unusually fast, slow, or irregular heartbeat; vomiting.

Proper storage of Zephrex LA Sustained-Release Tablets:

Store Zephrex LA Sustained-Release Tablets 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 Zephrex LA Sustained-Release Tablets out of the reach of children and away from pets.

General information:

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


• Zephrex LA 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 Zephrex LA 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

Copyright © 2012 Wolters Kluwer Health, Inc.

More Zephrex LA resources

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

Compare Zephrex LA with other medications

• Cough and Nasal Congestion

Aquacillin

Dosage Form: FOR ANIMAL USE ONLY
Drug Facts

Description General Information

Procaine penicillin G is a potent antibacterial agent which is effective against a variety of pathogenic organisms, chiefly in the Gram-positive category. Aquacillin is a free-flowing product prepared by combining penicillin G and procaine, molecule for molecule, with dispersing agents.

Residue Warnings

RESIDUE WARNINGS: (FDA Requested Revision) 100mL & 250mL-Label

Milk taken from animals during treatment and for 48 hours (4 milkings) after the latest treatment must not be used for food. A withdrawal period has not been established for this product in preruminating calves. Do not use in calves to be processed for veal.

Discontinue use of this drug for the following time periods before treated animals are slaughtered for food: Cattle-10 days, Sheep-9 days, Swine-7 days. Not for use in horses intended for food.

RESIDUE WARNINGS:(FDA Requested Revision) 100mL & 250mL-Onsert

Milk that has been taken from animals during treatment and for 48 hours (4 milkings) after the latest treatment must not be used for food. A withdrawal period has not been established for this product in preruminating calves. Do not use in calves to be processed for veal.

Discontinue use of this drug for the following time periods before treated animals are slaughtered for food: Cattle-10 days, Sheep-9 days, Swine-7 days. Not for use in horses intended for food.

WARNING: (Old revision) 500mL-Label

Milk taken from animals during treatment and for 48 hours (4 milkings) after the latest treatment must not be used for food. A withdrawal period has not been established for this product in preruminating calves. Do not use in veal calves.

Discontinue use of this drug for the following time periods before treated animals are slaughtered for food: Cattle-10 days, Sheep-9 days, Swine-7 days. Not for use in horses intended for food.

WARNING: (Old revision) 500mL-Onsert

Milk that has been taken from animals during treatment and for 48 hours (4 milkings) after the latest treatment must not be used for food. A withdrawal period has not been established for this product in preruminating calves. Do not use in veal calves.

Discontinue use of this drug for the following time periods before treated animals are slaughtered for food: Cattle-10 days, Sheep-9 days, Swine-7 days. Not for use in horses intended for food.

Aquacillin is a registered trademark of VEDCO, Inc.

LOT

EXP DATE

760001

Directions for Use

Aquacillin should be administered by the intramuscular route. A thoroughly cleaned, sterile needle and syringe should be used for each injection (needles and syringes may be sterilized by boiling in water for 15 minutes). Before withdrawing the solution from the bottle, disinfect the rubber cap on the bottle with a suitable disinfectant such as 70 percent alcohol. The injection site should be similarly cleaned with the disinfectant. Needles of 16 to 18 gauge and 1 to 1½ inches long are adequate for intramuscular injection.

INTRAMUSCULAR INJECTION: In livestock, intramuscular injection should be made by directing the needle of suitable gauge and length into the fleshy part of a thick muscle such as the rump, hip, or thigh region; avoid blood vessels and major nerves. Before injecting the solution, pull back gently on the plunger. If blood appears in the syringe, a blood vessel has been entered; withdraw the needle and select a different site. No more than 10mL should be injected at any one site in adult livestock; rotate injection sites for each succeeding treatment.

Care of sick animals: The use of antibiotics in the management of disease is based on an accurate diagnosis and an adequate course of treatment. When properly used in the treatment of diseases caused by penicillin-susceptible organisms. Most animals treated with Aquacillin show a noticeable improvement within 24 to 48 hours. If improvement does not occur within this period of time, the diagnosis and course of treatment should be re-evaluated. It is recommended that the diagnosis and treatment of animal diseases be carried out by a veterinarian. Since many diseases look alike but require different types of treatment, the use of professional veterinary and laboratory services can reduce treatment time, cost, and needless losses. Good housing, sanitation, and nutrition are important in the maintenance of healthy animals and are essential in the treatment of disease

Contains

Each mL of Aquacillin contains 300,000 units of procaine penicillin G and approximately: 0.08% sodium citrate; 0.15% sodium carboxymethylcellulose; 25% sorbitol solution; 0.06% povidone; 0.6% lecithin; 0.1% methylparaben; 0.01% propylparaben; 0.25% phenol.

Store between 2°-8°C (36°-46°F)

Restricted Drug (California)

Refer to package insert for complete directions.

 SHAKE WELL BEFORE USING.

Manufactured for VEDCO, Inc.

Manufactured By Teva Animal Health, Inc. Fort Dodge, IA 50501

Front Panel Label

Aquacillin

Penicillin-G Procaine In Aqueous Suspension

Injectable Antibiotic

For the treatment of disease in cattle, swine, sheep and horses.

For Intramuscular Use Only.

NOT FOR HUMAN USE

USE ONLY AS DIRECTED

NADA 65-110, Approved by FDA

Indications

INDICATIONS: (FDA Requested Revision) 100mL & 250mL-label

Aquacillin is recommended for treatment of bacterial pneumonia (shipping fever) caused by Pasteurella multocida in cattle and sheep, erysipelas caused by Erysipelothrix rhusiopathiae in swine, and strangles caused by streptococcus equi in horses.

INDICATIONS: (Old reversion) 500mL-label

Aquacillin is recommended for treatment of bacterial pneumonia (shipping fever) caused by Pasteurella multocida in cattle and sheep, erysipelas caused by Erysipelothrix insidiosa in swine, and strangles caused by streptococcus equi in horses.

DOSAGE LEVELS: The recommended daily dosage of penicillin is 3,000 units per pound of body weight (one mL per 100lb body weight). Continue daily treatment until recovery is apparent and for at least 1 day after symptoms disappear, usually in 2 or 3 days. Treatment should not exceed 4 consecutive days.

Precautions

Exceeding the highest recommended daily dosage of 3,000 units per pound of body weight, administering at recommended levels for more than 4 consecutive days, and/or exceeding 10mL intramuscularly per injection site may result in antibiotic residues beyond the withdrawal time.

Aquacillin should be injected deep within the fleshy muscles of the hip, rump, round, or thigh. Do not inject this material subcutaneously (under the skin), into a blood vessel, or near a major nerve.

Procaine penicillin G is a substance of low toxicity. However, side effects, or so-called allergic or anaphylactic reactions-sometimes fatal, have been known to occur in animals hypersensitive to penicillin and procaine. Such reactions can occur unpredictably with varying intensity. Animals administered Aquacillin should be kept under close observation for at least one-half hour. Should allergic or anaphylactic reactions occur, discontinue use of the product and immediately administer epinephrine following manufacturer’s recommendations; call a veterinarian. As with all antibiotic preparations, use of this drug may result in overgrowth of non-susceptible organisms, including fungi. A lack of response by the treated animal, or the development of new signs or symptoms suggest that an overgrowth of non-susceptible organisms has occurred. In such instances, consult your veterinarian. Since bactericidal drugs may interfere with the bacteriostatic action of tetracyclines, it is advisable to avoid giving penicillin in conjunction with tetracyclines. Penicillin-G should be stored between 2-8°C (36-46°F). Warm to room temperature and shake before using.

Directions

A thoroughly cleaned, sterile needle and syringe should be used for each injection (needles and syringes may be sterilized by boiling in later for 15 minutes). Before withdrawing the solution from the bottle, disinfect the rubber cap on the bottle with a suitable disinfectant such as 70 percent alcohol. The injection site should be similarly cleaned with the disinfectant. Needles of 16 to 18 gauge and not more than 1 to 1½ inch long are adequate for injections.

A subcutaneous injection should be made by pinching up a fold of the skin between the thumb and forefinger. The mid-neck region is the preferred injection site. Insert the needle under the fold in a direction approximately parallel to the surface of the body. When the needle is inserted in this manner the medication will be delivered underneath the skin between the skin and the muscles. Proper restraint, such as the use of a chute and nose lead, is needed for proper administration of the product.

SHAKE WELL BEFORE USING

FOR ANIMAL USE ONLY

RESTRICTED DRUG (CALIFORNIA)

USE ONLY AS DIRECTED

NOT FOR HUMAN USE

Storage

Store between 2°-8°C (36°-46°F)

Restricted Drug (California)-Use Only As Directed

Refer to label insert for complete directions.

SHAKE WELL BEFORE USING.

760001-

Rev

Manufactured By Teva Animal Health, Inc. Fort Dodge, IA 50501

Package Information

Aquacillin available in vials of 100mL, 250mL and 500mL with each mL containing 300,000 units of procaine penicillin G. The 500mL vial is intended for use with automatic syringes

FOR ANIMAL USE ONLY

RESTRICTED DRUG (California)

USE ONLY AS DIRECTED.

NOT FOR HUMAN USE.

Principle Display Panel

Principle Display Panel

Principle Display Panel

Aquacillin  penicillin g procaine  injection, suspension

Product Information Product Type OTC ANIMAL DRUG NDC Product Code (Source) 50989-660 Route of Administration INTRAMUSCULAR DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength PENICILLIN G PROCAINE (PENICILLIN G) PENICILLIN G PROCAINE 300000 ug  in 1 mL

Inactive Ingredients Ingredient Name Strength No Inactive Ingredients Found

Product Characteristics Color      Score      Shape Size Flavor Imprint Code Contains

Packaging # NDC Package Description Multilevel Packaging 1 50989-660-12 100 mL In 1 BOTTLE, GLASS None 2 50989-660-15 250 mL In 1 BOTTLE, GLASS None 3 50989-660-16 500 mL In 1 BOTTLE, GLASS None

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
NADA	NADA65110	07/18/2003	07/31/2009

Labeler - Vedco, Inc. (021634266)

Revised: 02/2010Vedco, Inc.

Gynazole-1 Cream

Pronunciation: byoo-toe-KOE-na-zole
Generic Name: Butoconazole
Brand Name: Gynazole-1

Gynazole-1 Cream is used for:

Treating vaginal yeast infections.

Gynazole-1 Cream is an antifungal agent. It works by weakening the cell wall of sensitive fungi, causing the cell contents to leak. This kills the fungi.

Do NOT use Gynazole-1 Cream if:

• you are allergic to any ingredient in Gynazole-1 Cream

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

Before using Gynazole-1 Cream:

Some medical conditions may interact with Gynazole-1 Cream. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

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


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


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

Some MEDICINES MAY INTERACT with Gynazole-1 Cream. However, no specific interactions with Gynazole-1 Cream are known at this time.

Ask your health care provider if Gynazole-1 Cream 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 Gynazole-1 Cream:

Use Gynazole-1 Cream as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• Gynazole-1 Cream is for vaginal use only. Do not use in the eyes or take by mouth.


• Wash your hands before and after using Gynazole-1 Cream. Insert 1 applicator-full of cream into the vagina. Throw the applicator away after using it.


• Only one dose of Gynazole-1 Cream is required. If you forget to use Gynazole-1 Cream, use it as soon as you remember.

Ask your health care provider any questions you may have about how to use Gynazole-1 Cream.

Important safety information:

• If your symptoms do not get better within a few days or if they get worse, check with your doctor.


• If your infection clears up and occurs again in a few weeks, see your doctor. Recurrent vaginal infections, especially those that are difficult to cure, may be an early sign of HIV infection in women who are considered at risk for HIV infection.


• Gynazole-1 Cream may be used during your period. Use a sanitary pad rather than a tampon to prevent staining of clothing.


• Gynazole-1 Cream contains mineral oil, which may weaken latex or rubber products such as condoms and diaphragms. Do not use condoms or diaphragms within 72 hours of using Gynazole-1 Cream.


• Gynazole-1 Cream 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 Gynazole-1 Cream while you are pregnant. It is not known if Gynazole-1 Cream is found in breast milk. If you are or will be breast-feeding while you use Gynazole-1 Cream, check with your doctor. Discuss any possible risks to your baby.

Possible side effects of Gynazole-1 Cream:

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:

Burning, itching, soreness, or swelling in or around the vagina not present before using Gynazole-1 Cream.

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); pain or cramping in the stomach or pelvic area.

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: Gynazole-1 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. Gynazole-1 Cream may be harmful if swallowed.

Proper storage of Gynazole-1 Cream:

Store Gynazole-1 Cream at 77 degrees F (25 degrees C). Brief storage at temperatures between 59 and 86 degrees F (15 and 30 degrees C) is permitted. Keep Gynazole-1 Cream out of the reach of children and away from pets.

General information:

• If you have any questions about Gynazole-1 Cream, please talk with your doctor, pharmacist, or other health care provider.


• Gynazole-1 Cream is to be used only by the patient for whom it is prescribed. Do not share it with other people.


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


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

This information is a summary only. It does not contain all information about Gynazole-1 Cream. 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 Gynazole-1 resources

• Gynazole-1 Side Effects (in more detail)
• Gynazole-1 Use in Pregnancy & Breastfeeding
• Gynazole-1 Support Group
• 2 Reviews for Gynazole-1 - Add your own review/rating

Compare Gynazole-1 with other medications

• Vaginal Yeast Infection