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Sunday, 4 March 2012

Freezone Topical

Generic Name: salicylic acid (Topical route)

sal-i-SIL-ik AS-id

Commonly used brand name(s)

In the U.S.

Akurza

Aliclen

Avosil

Betasal

Compound W

Corn Removing

Dermarest Psoriasis

DHS Sal

Drytex

Duofilm

Duoplant

Durasal

Freezone

Fung-O

Gets-It Corn/Callus Remover

Gordofilm

Hydrisalic

Ionil

Ionil Plus

Keralyt

Keralyt Scalp

Lupicare

Mediplast

Mg217 Sal-Acid

Mosco Corn & Callus Remover

Neutrogena

Occlusal-HP

Off-Ezy

Oxy Balance

P & S

Palmer's Skin Success Acne Cleanser

Propa pH

Salac

Sal-Acid Plaster

Salactic Film

Salex

Salitop

Salkera

Sal-Plant Gel

Salvax

Seba-Clear

Stri-Dex

Thera-Sal

Therasoft Anti-Acne

Tinamed

Ti-Seb

Virasal

Wart-Off Maximum Strength

Zapzyt

In Canada

Acnex

Acnomel Acne Mask

Clear Away Wart Removal System

Compound W One-Step Wart Remover

Compound W Plus

Dr. Scholl's Clear Away One Step Plantar Wart Remover

Dr. Scholl's Cushlin Ultra Slim Callus Removers

Dr. Scholl's Cushlin Ultra Slim Corn Removers

Duoforte 27

Freezone - One Step Callus Remover Pad

Freezone - One Step Corn Remover Pad

Available Dosage Forms:

Soap

Lotion

Liquid

Foam

Ointment

Gel/Jelly

Solution

Cream

Paste

Shampoo

Dressing

Stick

Therapeutic Class: Antiacne

Pharmacologic Class: NSAID

Chemical Class: Salicylate, Non-Aspirin

Uses For Freezone

Salicylic acid is used to treat many skin disorders, such as acne, dandruff, psoriasis, seborrheic dermatitis of the skin and scalp, calluses, corns, common warts, and plantar warts, depending on the dosage form and strength of the preparation.

Some of these preparations are available only with your doctor's prescription.

Before Using Freezone

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

Allergies

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

Pediatric

Young children may be at increased risk of unwanted effects because of increased absorption of salicylic acid through the skin. Also, young children may be more likely to get skin irritation from salicylic acid. Salicylic acid should not be applied to large areas of the body, used for long periods of time, or used under occlusive dressing (air-tight covering, such as kitchen plastic wrap) in infants and children. Salicylic acid should not be used in children younger than 2 years of age.

Geriatric

Elderly people are more likely to have age-related blood vessel disease. This may increase the chance of problems during treatment with this medicine.

Breast Feeding

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

Interactions with Medicines

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

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

Abciximab

Argatroban

Bivalirudin

Cilostazol

Citalopram

Clovoxamine

Dabigatran Etexilate

Dipyridamole

Escitalopram

Femoxetine

Flesinoxan

Fluoxetine

Fluvoxamine

Fondaparinux

Heparin

Lepirudin

Nefazodone

Paroxetine

Protein C

Rivaroxaban

Sertraline

Sibutramine

Ticlopidine

Tirofiban

Vilazodone

Zimeldine

Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

Acenocoumarol

Anisindione

Ardeparin

Azilsartan Medoxomil

Azosemide

Bemetizide

Bendroflumethiazide

Benzthiazide

Bumetanide

Buthiazide

Candesartan Cilexetil

Certoparin

Chlorothiazide

Chlorthalidone

Clopamide

Cyclopenthiazide

Dalteparin

Danaparoid

Dicumarol

Enoxaparin

Eprosartan

Ethacrynic Acid

Furosemide

Hydrochlorothiazide

Hydroflumethiazide

Indapamide

Irbesartan

Losartan

Methyclothiazide

Metolazone

Nadroparin

Olmesartan Medoxomil

Parnaparin

Phenindione

Phenprocoumon

Piretanide

Polythiazide

Probenecid

Reviparin

Tamarind

Tasosartan

Telmisartan

Tinzaparin

Torsemide

Trichlormethiazide

Valsartan

Warfarin

Xipamide

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.

Proper Use of salicylic acid

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

It is very important that you use this medicine only as directed. Do not use more of it, do not use it more often, and do not use it for a longer time than recommended on the label, unless otherwise directed by your doctor. To do so may increase the chance of absorption through the skin and the chance of salicylic acid poisoning.

If your doctor has ordered an occlusive dressing (airtight covering, such as kitchen plastic wrap) to be applied over this medicine, make sure you know how to apply it. Since an occlusive dressing will increase the amount of medicine absorbed through your skin and the possibility of salicylic acid poisoning, use it only as directed. If you have any questions about this, check with your doctor.

Keep this medicine away from the eyes and other mucous membranes, such as the mouth and inside of the nose. If you should accidentally get some in your eyes or on other mucous membranes, immediately flush them with water for 15 minutes.

To use the cream, lotion, or ointment form of salicylic acid:

Apply enough medicine to cover the affected area, and rub in gently.

To use the gel form of salicylic acid:

Before using salicylic acid gel, apply wet packs to the affected areas for at least 5 minutes. If you have any questions about this, check with your health care professional.

Apply enough gel to cover the affected areas, and rub in gently.

To use the pad form of salicylic acid:

Wipe the pad over the affected areas.

Do not rinse off medicine after treatment.

To use the plaster form of salicylic acid for warts, corns, or calluses:

This medicine comes with patient instructions. Read them carefully before using.

Do not use this medicine on irritated skin or on any area that is infected or reddened. Also, do not use this medicine if you are a diabetic or if you have poor blood circulation.

Do not use this medicine on warts with hair growing from them or on warts on the face, in or on the genital (sex) organs, or inside the nose or mouth. Also do not use on moles or birthmarks. To do so may cause severe irritation.

Wash the area to be treated and dry thoroughly. Warts may be soaked in warm water for 5 minutes before drying.

Cut the plaster to fit the wart, corn, or callus and apply.

For corns and calluses:
- Repeat every 48 hours as needed for up to 14 days, or as directed by your doctor, until the corn or callus is removed.
- Corns or calluses may be soaked in warm water for 5 minutes to help in their removal.

For warts:
- Depending on the product, either:
  - Apply plaster and repeat every 48 hours as needed, or
    - Apply plaster at bedtime, leave in place for at least 8 hours, remove plaster in the morning, and repeat every 24 hours as needed.
- Repeat for up to 12 weeks as needed, or as directed by your doctor, until wart is removed.

If discomfort gets worse during treatment or continues after treatment, or if the wart spreads, check with your doctor.

To use the shampoo form of salicylic acid:

Before applying this medicine, wet the hair and scalp with lukewarm water. Apply enough medicine to work up a lather and rub well into the scalp for 2 or 3 minutes, then rinse. Apply the medicine again and rinse thoroughly.

To use the soap form of salicylic acid:

Work up a lather with the soap, using hot water, and scrub the entire affected area with a washcloth or facial sponge or mitt.

If you are to use this soap in a foot bath, work up rich suds in hot water and soak the feet for 10 to 15 minutes. Then pat dry without rinsing.

To use the topical solution form of salicylic acid for acne:

Wet a cotton ball or pad with the topical solution and wipe the affected areas.

Do not rinse off medicine after treatment.

To use the topical solution form of salicylic acid for warts, corns, or calluses:

This medicine comes with patient instructions. Read them carefully before using.

This medicine is flammable. Do not use it near heat or open flame or while smoking.

Do not use this medicine on irritated skin or on any area that is infected or reddened. Also, do not use this medicine if you are a diabetic or if you have poor blood circulation.

Do not use this medicine on warts with hair growing from them or on warts on the face, in or on the genital (sex) organs, or inside the nose or mouth. Also do not use on moles or birthmarks. To do so may cause severe irritation.

Avoid breathing in the vapors from the medicine.

Wash the area to be treated and dry thoroughly. Warts may be soaked in warm water for 5 minutes before drying.

Apply the medicine one drop at a time to completely cover each wart, corn, or callus. Let dry.

For warts—Repeat one or two times a day as needed for up to 12 weeks, or as directed by your doctor, until wart is removed.

For corns and calluses—Repeat one or two times a day as needed for up to 14 days, or as directed by your doctor, until the corn or callus is removed.

Corns and calluses may be soaked in warm water for 5 minutes to help in their removal.

If discomfort gets worse during treatment or continues after treatment, or if the wart spreads, check with your doctor.

Unless your hands are being treated, wash them immediately after applying this medicine to remove any medicine that may be on them.

Dosing

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

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

For cream dosage form:
- For corns and calluses:
  - Adults and children—Use the 2 to 10% cream as needed. Use the 25 to 60% cream one time every three to five days.

For gel dosage form:
- For acne:
  - Adults and children—Use the 0.5 to 5% gel one time a day.
- For psoriasis:
  - Adults and children—Use the 5% gel one time a day.
- For common warts:
  - Adults and children—Use the 5 to 26% gel one time a day.

For lotion dosage form:
- For acne:
  - Adults and children—Use the 1 to 2% lotion one to three times a day.
- For dandruff and antiseborrhic dermatitis of the scalp:
  - Adults and children—Use the 1.8 to 2% lotion on the scalp one or two times a day.

For ointment dosage form:
- For acne:
  - Adults and children—Use the 3 to 6% ointment as needed.
- For psoriasis and seborrheic dermatitis:
  - Adults and children—Use the 3 to 10% ointment as needed.
- For common warts:
  - Adults and children—Use the 3 to 10% ointment as needed. Use the 25 to 60% ointment one time every three to five days.

For pads dosage form:
- For acne:
  - Adults and children—Use one to three times a day.

For plaster dosage form:
- For corns, calluses, common warts, or plantar warts:
  - Adults and children—Use one time a day or one time every other day.

For shampoo dosage form:
- For dandruff or seborrheic dermatitis of the scalp:
  - Adults and children—Use on the scalp one or two times a week.

For soap dosage form:
- For acne:
  - Adults and children—Use as needed.

For topical solution dosage form:
- For acne:
  - Adults and children—Use the 0.5 to 2% topical solution one to three times a day.
- For common warts and plantar warts:
  - Adults and children—Use the 5 to 27% topical solution one or two times a day.
- For corns and calluses:
  - Adults and children—Use the 12 to 27% topical solution one or two times a day.

Missed Dose

If you miss a dose of this medicine, apply it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule.

Storage

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

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Precautions While Using Freezone

When using salicylic acid, do not use any of the following preparations on the same affected area as this medicine, unless otherwise directed by your doctor:

Abrasive soaps or cleansers

Alcohol-containing preparations

Any other topical acne preparation or preparation containing a peeling agent (for example, benzoyl peroxide, resorcinol, sulfur, or tretinoin [vitamin A acid])

Cosmetics or soaps that dry the skin

Medicated cosmetics

Other topical medicine for the skin

To use any of the above preparations on the same affected area as salicylic acid may cause severe irritation of the skin.

Check with your doctor right away if you have nausea, vomiting, dizziness, loss of hearing, tinnitus, lethargy hyperpnea, diarrhea, and psychic disturbances. These could be symptoms of a serious condition called salicylate toxicity, especially in children under 12 years of age and patients with kidney or liver problems.

Freezone Side Effects

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

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

Less common or rare

Skin irritation not present before use of this medicine (moderate or severe)

Frequency not known

Dryness and peeling of skin

flushing

redness of skin

unusually warm skin

Symptoms of salicylic acid poisoning

Confusion

diarrhea

dizziness

fast or deep breathing

headache (severe or continuing)

hearing loss

lightheadedness

nausea

rapid breathing

ringing or buzzing in ears (continuing)

severe drowsiness

stomach pain

vomiting

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:

More common

Skin irritation not present before use of this medicine (mild)

stinging

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

See also: Freezone Topical side effects (in more detail)

The information contained in the Thomson Reuters Micromedex products as delivered by Drugs.com is intended as an educational aid only. It is not intended as medical advice for individual conditions or treatment. It is not a substitute for a medical exam, nor does it replace the need for services provided by medical professionals. Talk to your doctor, nurse or pharmacist before taking any prescription or over the counter drugs (including any herbal medicines or supplements) or following any treatment or regimen. Only your doctor, nurse, or pharmacist can provide you with advice on what is safe and effective for you.

The use of the Thomson Reuters Healthcare products is at your sole risk. These products are provided "AS IS" and "as available" for use, without warranties of any kind, either express or implied. Thomson Reuters Healthcare and Drugs.com make no representation or warranty as to the accuracy, reliability, timeliness, usefulness or completeness of any of the information contained in the products. Additionally, THOMSON REUTERS HEALTHCARE MAKES NO REPRESENTATION OR WARRANTIES AS TO THE OPINIONS OR OTHER SERVICE OR DATA YOU MAY ACCESS, DOWNLOAD OR USE AS A RESULT OF USE OF THE THOMSON REUTERS HEALTHCARE PRODUCTS. ALL IMPLIED WARRANTIES OF MERCHANTABILITY AND FITNESS FOR A PARTICULAR PURPOSE OR USE ARE HEREBY EXCLUDED. Thomson Reuters Healthcare does not assume any responsibility or risk for your use of the Thomson Reuters Healthcare products.

Compare Freezone Topical with other medications

Acne
Dermatological Disorders

Vicks VapoSteam Liquid

Pronunciation: KAM-for
Generic Name: Camphor
Brand Name: Vicks VapoSteam

Vicks VapoSteam Liquid is used for:

Temporarily relieving cough due to the common cold. It is used along with a steam vaporizer. It may also be used for other conditions as determined by your doctor.

Vicks VapoSteam Liquid is a cough suppressant. It works by helping steam to moisten breathing passages.

Do NOT use Vicks VapoSteam Liquid if:

you are allergic to any ingredient in Vicks VapoSteam Liquid

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

Before using Vicks VapoSteam Liquid:

Some medical conditions may interact with Vicks VapoSteam Liquid. 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 have a persistent cough (eg, due to smoking), breathing or lung problems (eg, asthma, emphysema), or a cough with a lot of mucus

Some MEDICINES MAY INTERACT with Vicks VapoSteam Liquid. However, no specific interactions with Vicks VapoSteam Liquid are known at this time.

Ask your health care provider if Vicks VapoSteam Liquid 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 Vicks VapoSteam Liquid:

Use Vicks VapoSteam Liquid as directed by your doctor. Check the label on the medicine for exact dosing instructions.

Add Vicks VapoSteam Liquid to cold water only in a hot steam vaporizer as directed by your doctor or on the product label.

Follow the manufacturer's directions for using a vaporizer. Ask your doctor or pharmacist if you have any questions on how to use a vaporizer.

Breathe in medicated vapors. Do not allow steam to get too close to your face.

If you miss a dose of Vicks VapoSteam Liquid, use it as soon as you remember. Continue to use it as directed by your doctor or on the package label.

Ask your health care provider any questions you may have about how to use Vicks VapoSteam Liquid.

Important safety information:

Vicks VapoSteam Liquid may cause harm if it is swallowed. If you may have taken it by mouth, contact your poison control center or emergency room right away.

Vicks VapoSteam Liquid is for external use only. Do not take it by mouth. Do not get Vicks VapoSteam Liquid in your eyes. If you get it in your eyes, rinse at once with cool water.

Vicks VapoSteam Liquid is flammable. Do not use it near an open flame. Do not heat or microwave Vicks VapoSteam Liquid.

If your symptoms do not get better within 7 days, get worse, or if you develop a high fever or persistent headache, check with your doctor.

Vicks VapoSteam Liquid should not be used in CHILDREN younger than 2 years old without first checking with your child's doctor; safety and effectiveness in these 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 Vicks VapoSteam Liquid while you are pregnant. If you are or will be breast-feeding while you use Vicks VapoSteam Liquid, check with your doctor. Discuss any possible risks to your baby.

Possible side effects of Vicks VapoSteam Liquid:

All medicines may cause side effects, but many people have no, or minor, side effects. No COMMON side effects have been reported with Vicks VapoSteam Liquid. 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).

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: Vicks VapoSteam 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.

Proper storage of Vicks VapoSteam Liquid:

Store Vicks VapoSteam Liquid at room temperature, between 68 and 77 degrees F (20 and 25 degrees C). Store away from heat. Keep Vicks VapoSteam Liquid out of the reach of children and away from pets.

General information:

If you have any questions about Vicks VapoSteam Liquid, please talk with your doctor, pharmacist, or other health care provider.

Vicks VapoSteam Liquid is to be used only by the patient for whom it is prescribed. Do not share it with other people.

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

This information is a summary only. It does not contain all information about Vicks VapoSteam Liquid. If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.

Issue Date: February 1, 2012

Database Edition 12.1.1.002

More Vicks VapoSteam resources

Vicks VapoSteam Side Effects (in more detail)
Vicks VapoSteam Use in Pregnancy & Breastfeeding
Vicks VapoSteam Support Group
0 Reviews · Be the first to review/rate this drug

Saturday, 3 March 2012

immune globulin Injection

i-MUNE GLOB-ue-lin

Intravenous route(Powder for Solution;Solution)

Immune globulin intravenous (IGIV) products have been reported to be associated with renal dysfunction, acute renal failure, osmotic nephrosis, and death. Use caution in patients predisposed to acute renal failure and administer at the minimum concentration available and the minimum rate of infusion practicable in such patients. Higher rates of renal failure were associated with IGIV products containing sucrose . Flebogamma(R) 5%, Flebogamma(R) 5% DIF, Flebogamma(R) 10% DIF, Gammagard (R), Gamunex(R)-C, and Previgen(R) do not contain sucrose . Glycine is used as a stabilizer in Gamunex(R)-C .

Subcutaneous route(Solution)

Commonly used brand name(s)

In the U.S.

Baygam

Carimune

Gamimune N

Gammagard

Gammar-P

Hizentra

Iveegam EN

Octagam

Panglobulin NF

Polygam S/D

Sandoglobulin

Vivaglobin

Available Dosage Forms:

Solution

Powder for Solution

Therapeutic Class: Immune Serum

Uses For immune globulin

Immune globulin injection belongs to a group of medicines known as immunizing agents. It is used to prevent or treat diseases that occur when your body has a weak immune system. Immune globulin contains antibodies that make your immune system stronger. It is used for patients who have primary humoral immunodeficiency (PI), idiopathic thrombocytopenic purpura (ITP), and chronic inflammatory demyelinating polyneuropathy (CIDP).

immune globulin is to be administered only by or under the supervision of your doctor.

Once a medicine has been approved for marketing for a certain use, experience may show that it is also useful for other medical problems. Although these uses are not included in product labeling, immune globulin is used in certain patients with the following medical conditions:

Chronic parvovirus B19 infection (treatment).

Dermatomyositis (treatment).

Guillain-Barré syndrome (treatment).

Hyperimmunoglobulinemia E syndrome (treatment).

Infections in low-birth-weight preterm high-risk neonates (prophylaxis and treatment adjunct).

Lambert-Eaton myasthenic syndrome (treatment).

Multifocal motor neuropathy (treatment).

Relapsing-remitting multiple sclerosis (treatment).

Before Using immune globulin

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 immune globulin, the following should be considered:

Allergies

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

Pediatric

Appropriate studies performed to date have not demonstrated pediatric-specific problems that would limit the usefulness of immune globulin injection in children. However, safety and efficacy have not been established in children with CIDP, safety and efficacy have not been established for Flebogamma® and subcutaneous injection of Gamunex®-C in children with PI, and safety and efficacy have not been established for Gammagard Liquid and Vivaglobin® in children younger than 2 years of age.

Geriatric

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of immune globulin injection in the elderly. However, elderly patients are more likely to have age-related blood clotting problems, kidney disease, or heart disease, which may require caution for patients receiving immune globulin injection.

Pregnancy

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

Breast Feeding

Studies in women suggest that this medication poses minimal risk to the infant when used during breastfeeding.

Interactions with Medicines

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

Interactions with Food/Tobacco/Alcohol

Proper Use of immune globulin

A doctor or other trained health professional will give you or your child immune globulin. immune globulin is given through a needle placed in one of your veins, as a shot into one of your muscles, or as a shot under your skin.

immune globulin comes with a patient information insert. Read and follow the instructions carefully. Ask your doctor if you have any questions.

While you or your child are being treated with immune globulin injection, do not have any immunizations (vaccines) without your doctor's approval. Live virus vaccines should not be given for 3 months after receiving immune globulin.

The Gammagard Liquid, Gamunex®-C, Hizentra®, and Vivaglobin® products may sometimes be given at home to patients who do not need to be in the hospital or clinic. They are given as an infusion under your skin once every week. If you or your child are using immune globulin at home, your doctor will teach you how to prepare and infuse the medicine. Be sure you understand how to use the medicine.

Do not change the brand or type of your immune globulin unless your doctor tells you to. If you or your child must change the brand or type of medicine, talk to your doctor before giving yourself an injection.

If you or your child are using Gammagard Liquid, Gamunex®-C, Hizentra®, or Vivaglobin® at home, you will be shown the body areas where the medicine can be given. Use a different body area each time you give yourself an infusion. Keep track of where you give each infusion to make sure you rotate body areas. This will help prevent skin problems.

Allow the Gammagard Liquid, Gamunex®-C, or Vivaglobin® brand to reach room temperature before using it.

To use Gammagard Liquid, Gamunex®-C, Hizentra®, or Vivaglobin®:

First, gather the items you will need on a clean, flat surface using a cloth or towel in a well-lighted area.

Wash your hands with soap and water before and after using immune globulin.

If you have been told to wear gloves when preparing your infusion, put the gloves on.

Check the liquid in the vial (glass container). It should be clear and slightly yellow to light brown in color. If it is cloudy, discolored, or contains large flecks (particles), do not use the vial. Select another vial.

If the liquid is clear, place it on the clean, flat surface. Do not heat up or shake the medicine.

Follow your doctor's instructions on how to prepare the correct amount of medicine.

Choose an injection site on your body (e.g., abdomen or stomach area, thigh, upper arm, upper leg, or hip). Clean the injection site with a fresh alcohol wipe, and let it dry.

With two fingers, pinch together the skin at the injection site. Insert the needle with the tube under the skin.

Put sterile gauze and tape over the injection site to keep the needle from coming out.

Before starting the infusion, make sure no blood is flowing into the infusion tube. If blood is present, remove and throw away the used needle and tube.

Follow your doctor's instructions on how to use the infusion pump.

Remove the peel-off portion of the label from the used vial. Place this label in your treatment diary or log book. Write down the amount of medicine you used, the date, and the time of your treatment.

It usually takes about 60 minutes for each infusion.

When all of the medicine has been infused, turn off the pump.

Take the gauze off and remove the needle and tube from your skin.

Clean and store the infusion pump.

Throw away used needles and tubes in a hard, closed container that the needles cannot poke through. Keep this container away from children and pets.

Missed Dose

immune globulin needs to be given on a fixed schedule. If you miss a dose or forget to use your medicine, call your doctor or pharmacist for instructions.

Storage

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

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

Store the Hizentra® product at room temperature, away from heat and moisture. Keep from freezing.

Protect the Hizentra® product from direct light. Keep the medicine in the original package until you are ready to use it.

Store the Gamunex®-C and Vivaglobin® products in the refrigerator, but do not freeze the medicine. Store it in the original container.

You may store the Gammagard Liquid product in the refrigerator for 36 months, or at room temperature for up to 12 months (if within the first 24 months of the date of manufacture). Check the box for the date of manufacture. Store it in the original container. Do not freeze. Talk with your pharmacist if you have questions about storage of this product.

Precautions While Using immune globulin

It is very important that your doctor check the progress of you or your child at regular visits for any problems that may be caused by immune globulin. Blood and urine tests may be needed to check for unwanted effects.

Patients with idiopathic thrombocytopenic purpura (ITP) should not be treated with Gamunex®-C that is injected under the skin (subcutaneously). Doing so may increase the risk of having a hematoma (buildup of blood under the skin).

immune globulin may cause fever, chills, flushing, headaches, nausea, and vomiting, especially if you are receiving it for the first time or if you have not received it for more than 8 weeks. Check with your doctor or nurse right away if you have any of these symptoms.

immune globulin is made from donated human blood. Some human blood products have transmitted certain viruses to people who have received them. The risk of getting a virus from medicines made from human blood has been greatly reduced in recent years. This is the result of required testing of human donors for certain viruses, and required testing of the medicine when it is made. Although the risk is low, talk with your doctor if you have concerns.

immune globulin may cause a serious type of allergic reaction, including anaphylaxis, which can be life-threatening and requires immediate medical attention. Tell your doctor right away if you or your child have a rash, itching, hives, chest pain, dizziness or lightheadedness, trouble breathing, trouble swallowing, or any swelling of your hands, face, or mouth after receiving immune globulin. Certain people, including those with IgA (an immunoglobulin) deficiency and antibodies against IgA and a history of hypersensitivity to human immunoglobulin products should not use immune globulin.

Check with your doctor right away if you or your child start to have a stiff neck, drowsiness, fever, severe headache, nausea or vomiting, painful eye movements, or eye sensitivity to light. These could be symptoms of a serious condition called aseptic meningitis syndrome (AMS).

immune globulin may cause bleeding (hemolysis) or hemolytic anemia. Tell your doctor right away if you or your child have stomach or back pain, dark urine, decreased urination, difficulty with breathing, an increased heart rate, tiredness, or yellow eyes or skin after you receive the medicine.

Check with your doctor right away if you or your child start having chest pain; difficult, fast, or noisy breathing, sometimes with wheezing; blue lips and fingernails; fever; pale skin; increased sweating; coughing that sometimes produces a pink frothy sputum; shortness of breath; or swelling of the legs and ankles, after receiving immune globulin. These may be symptoms of a serious lung problem.

immune globulin may cause blood clots. This is more likely to occur if you have a history of blood clotting problems, heart disease, or atherosclerosis (hardening of the arteries), or if you are obese, take medicines containing estrogen, or must stay in bed for a long time because of surgery or illness. Check with your doctor right away if you or your child suddenly have chest pain, shortness of breath, a severe headache, leg pain, or problems with vision, speech, or walking. .

Check with your doctor right away if you or your child start having red or dark brown urine; lower back or side pain; a sudden weight gain; a swollen face, arms, or legs; decreased urine output; or any problems with urination after you receive immune globulin. These may be symptoms of a serious kidney problem.

Make sure any doctor or dentist who treats you knows that you are using immune globulin. immune globulin may affect the results of certain medical tests.

immune globulin 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 or nurse immediately if any of the following side effects occur:

More common

Chills

cough

difficulty with breathing

fast, pounding, or irregular heartbeat or pulse

fever

noisy breathing

shortness of breath

tightness in the chest

troubled breathing

unusual tiredness or weakness

Less common

Bluish coloring of the lips or nailbeds

burning sensation in the head

faintness or lightheadedness

Rare

Difficulty with swallowing

hives or welts

itching, especially of the feet or hands

reddening of the skin, especially around the ears

swelling of the eyes, face, or inside of the nose

Incidence not known

Back, leg, or stomach pains

bleeding gums

blistering, peeling, or loosening of the skin

bloody, black, or tarry stools

blurred vision

change in consciousness

chest pain or discomfort

cold, clammy, or pale skin

confusion

convulsions

coughing that sometimes produces a pink frothy sputum

dark urine

decrease in urine amount

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

fever with or without chills

headache that is severe and occurs suddenly

increased sweating

light-colored stools

loss of appetite

loss of bladder control

loss of consciousness

low blood pressure or pulse

muscle spasm or jerking of all extremities

nausea or vomiting

nosebleeds

painful or difficult urination

pains in the chest, groin, or legs, especially calves of the legs

red skin lesions, often with a purple center

red, irritated eyes

shakiness in the legs, arms, hands, or feet

shivering

skin blisters

slurred speech that occurs suddenly

slow breathing

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

sudden loss of consciousness

sudden loss of coordination

sudden vision changes

sudden, severe weakness or numbness in the arm or leg

sweating

swelling in the legs and ankles

tightness in the chest

trembling or shaking of the hands or feet

unusual bleeding or bruising

yellow eyes or skin

More common

Diarrhea

dizziness

headache

joint pain

muscle pain

redness, swelling, itching, or pain at the injection site

skin rash

Less common

Hip pain

leg cramps

Incidence not known

Feeling of warmth

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

stomach pain

swollen glands

tiredness

weakness

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.

More immune globulin Injection resources

Immune globulin Injection Use in Pregnancy & Breastfeeding
Immune globulin Injection Drug Interactions
Immune globulin Injection Support Group
5 Reviews for Immune globulin Injection - Add your own review/rating

Compare immune globulin Injection 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

Valaciclovir 500mg film coated tablets

1. Name Of The Medicinal Product

Valaciclovir 500mg film coated tablets

2. Qualitative And Quantitative Composition

Each film-coated tablet contains valaciclovir 500 mg as valaciclovir hydrochloride.

For a full list of excipients, see section 6.1.

3. Pharmaceutical Form

Film coated tablet.

White, oblong, biconvex film coated tablets

4. Clinical Particulars

4.1 Therapeutic Indications

Treatment of shingles (herpes zoster) infection.

Herpes simplex infections of the skin and mucous membranes, including initial and recurrent genital herpes.

Prophylaxis of recurrent herpes simplex infections of the skin and mucous membranes, including genital herpes.

Prophylaxis of cytomegalovirus (CMV) infection following renal transplantation.

4.2 Posology And Method Of Administration

Treatment of shingles (herpes zoster)

The dosage in adults is 1000 mg three times a day for 7 days. The treatment should be started as soon as possible after the symptoms appear, preferably within 72 hours.

Treatment of herpes simplex infections

The dosage in adults is 500 mg of valaciclovir twice daily.

For recurrent infections, treatment should be maintained for 5 days. For initial episodes, which can be more severe, treatment may have to be extended to 10 days. Dosing should begin as early as possible. For recurrent episodes of herpes simplex, this should ideally be during the prodromal period or as soon as the first signs appear.

Prophylaxis of recurrences of herpes simplex infections

Immunocompetent patients should take 500 mg of valaciclovir once daily.

Some patients with very frequent recurrences (e.g. more than 10 per year) may benefit from the daily dose of 500 mg being taken as a divided dose (250 mg twice daily). Valaciclovir 500mg film coated tablets is not suitable for these patients since it is not available as 250 mg tablets.

For immunocompromised adult patients the dose is 500 mg twice daily.

Reduction of transmission of genital herpes:

Valaciclovir 500mg film coated tablets can reduce transmission of genital herpes when taken as suppressive therapy and combined with safer sex practices.

Recommended dosage in immunocompetent heterosexual adult patients with 9 or fewer recurrences per year, 500 mg of Valaciclovir 500mg film coated tablets to be taken once daily by the infected partner in order to reduce transmission to a sexual partner negative for HSV-2 antibodies. Safer sex practices (particularly condom use) should be maintained, and sexual contact avoided if lesions are present.

There are no data on the reduction of transmission beyond 8 months in other patient populations.

Prophylaxis of cytomegalovirus infection (CMV)

Dosage in adults and children over 12 years of age

Two g (four tablets) four times a day. The first dose should be administered as early as possible post-transplant. This dose should be reduced according to creatinine clearance (see Dosage in patients with renal impairment below).

The duration of treatment will usually be 90 days, but may need to be extended in high risk patients.

Dosage in patients with renal impairment

Herpes zoster treatment and herpes simplex treatment or prophylaxis:

The dosage of valaciclovir should be reduced in patients with significantly impaired renal function as shown in the table below:

Indication	Creatinine clearance ml/min	Dosage
Shingles (Herpes zoster)	15-30	1 g twice daily
	less than 15	1 g once daily

Herpes simplex (treatment)	less than 15	500 mg once daily

Herpes simplex (prophylaxis):
- immunocompetent patients	less than 15	250 mg once daily
- immunocompromised patients Reduction of transmission of genital herpes:	less than 15 less than 15	500 mg once daily 250 mg once daily

In patients on haemodialysis the same dosage is recommended as for patients with creatinine clearance less than 15 ml/min. The dose should be administered following each dialysis.

Prophylaxis of cytomegalovirus infection:

Doses for patients with impaired renal function should be adjusted according to the following table:

Creatinine clearance ml/min

Dosage

>75

50 to less than 75

25 to less than 50

10 to less than 25

<10 or dialysis*

2 g four times daily

1.5 g four times a day

1.5 g three times a day

1.5 g twice a day

1.5 g once a day

*Administration to dialysis patients should follow each dialysis.

The creatinine clearance should be monitored closely, especially during periods when renal function is changing rapidly e.g. immediately after transplantation or engraftment. The dosage should be adjusted according to creatinine clearance.

Dosage in patients with hepatic impairment:

Studies with a single 1 g dose of valaciclovir show that dose adjustment is not required in patients with mild or moderate cirrhosis (hepatic synthetic function maintained). Pharmacokinetic data in patients with advanced cirrhosis, (impaired hepatic synthetic function and evidence of portal-systemic shunting) do not indicate the need for dosage adjustment; but clinical experience is limited. For high doses recommended in CMV prophylaxis, see section 4.4.

Dosage in children under 12 years of age:

No information with respect to this age group is available.

Dosage in the elderly:

No dose adjustment is necessary except in case of severe renal impairment (see Dosage in patients with renal impairment above). Sufficient fluid intake must be considered.

4.3 Contraindications

Hypersensitivity to valaciclovir, aciclovir or any of the excipients.

4.4 Special Warnings And Precautions For Use

Fluid balance

Care should be taken to ensure adequate fluid intake in patients who are at risk of dehydration, particularly the elderly and patients with reduced creatinine clearance.

Use in patients with renal impairment

The dosage should be adjusted in patients with renal impairment (see section 4.2). Patients with a history of renal impairment are also at increased risk of developing neurological effects (see section 4.8).

Use of higher doses of the medicinal product in patients with hepatic impairment

There is no data available on the use of higher doses of the product (8 g/day) in patients with liver disease. Caution should therefore be exercised when administering higher doses of valaciclovir to these patients.

This medicinal product contains lactose. Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicine.

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

No clinically significant interactions have been identified.

Aciclovir is excreted primarily unchanged in the urine via active renal tubular secretion. Any medicinal products administered concurrently that are excreted the same way may increase aciclovir blood concentrations following valaciclovir administration.

Following administration of 1 g of valaciclovir, cimetidine and probenecid increase the AUC of aciclovir by this mechanism, and reduce aciclovir urine excretion. However, no dosage adjustment is necessary at this dose because of the high therapeutic index of aciclovir.

In patients receiving higher doses of valaciclovir (8 g /day) as cytomegalovirus prophylaxis, caution is required during concurrent administration with medicinal products which compete with aciclovir for elimination, because of the potential for increased blood levels of one or both products. Increases in AUCs of aciclovir and of the inactive metabolite of mycophenolate mofetil, an immunosuppressant agent used in transplant patients, have been seen when the medicinal products are co-administered.

Caution is also required (with monitoring for changes in renal function) if administering high doses of valaciclovir with medicinal products which affect other aspects of renal function (e.g. ciclosporin, tacrolimus).

4.6 Pregnancy And Lactation

Pregnancy

There is limited data on the use of valaciclovir in pregnancy. Valaciclovir should only be used in pregnancy if the potential benefits of treatment outweigh the potential risk.

Pregnancy registries have documented the pregnancy outcomes in women exposed to valaciclovir or to any formulation of aciclovir (the active metabolite of valaciclovir); 111 and 1246 cases (29 and 756 exposed during the first trimester of pregnancy), respectively. The findings of the aciclovir pregnancy registry have not shown an increase in the number of birth defects amongst aciclovir-exposed subjects compared with the general population, and any birth defects showed no uniqueness or consistent pattern to suggest a common cause. Given the small number of women enrolled into the valaciclovir pregnancy registry, reliable and definitive conclusions could not be reached regarding the safety of valaciclovir in pregnancy. (See also section 5.2).

Lactation

The principle metabolite of valaciclovir is aciclovir which is excreted in breast milk. Aciclovir has been detected in breast milk at concentrations ranging from 0.6 to 4.1 times the corresponding aciclovir blood concentrations. Following oral administration of 200 mg aciclovir five times a day, the peak plasma concentration (C^ssmax) is 3.1 microM (0.7 mcg/ml). These levels would potentially expose nursing infants to aciclovir dosages of up to 0.3 mg/kg/day. The elimination half-life of aciclovir from breast milk has been measured 2.8 hours, similar to that in blood. Caution is therefore advised if valaciclovir is to be administered to nursing women. However aciclovir is used to treat neonatal herpes simplex at intravenous doses of 30 mg/kg/day.

4.7 Effects On Ability To Drive And Use Machines

The clinical status of the patient and the adverse event profile of valaciclovir should be borne in mind when considering the patient's ability to drive or operate machinery. There have been no studies to investigate the effect of valaciclovir on driving performance or the ability to operate machinery. A detrimental effect on such activities cannot be predicted from the pharmacology of the active substance.

4.8 Undesirable Effects

Adverse reactions are listed below by MedDRA body system organ class and by frequency.

The frequency categories used are:

Very common
Common
Uncommon
Rare
Very rare	< 1/10,000

Results from clinical trials have been used to evaluate the frequency of adverse reactions, when the trials established association with valaciclovir (i.e. there was a statistically significant difference between the incidence in patients taking valaciclovir and placebo). The frequency of other adverse reactions has been assessed by post-marketing adverse reactions reports.

Clinical Trial Data

Nervous system disorders

Common: Headache.

Gastrointestinal disorders

Common: Nausea.

Post Marketing Data

Blood and lymphatic system disorders

Very rare: Thrombocytopenia, leukopenia

Immune system disorders

Very rare: Anaphylaxis.

Psychiatric and nervous system disorders

Rare: Dizziness, confusion, hallucinations, decreased consciousness.

Very rare: Tremor, ataxia, dysarthria, convulsions, encephalopathy, coma.

The above adverse reactions are reversible and usually seen in patients with renal impairment or with other predisposing factors. In organ transplant patients receiving high doses (8 g daily) of valaciclovir for cytomegalovirus infection prophylaxis, neurological reactions occurred more frequently compared with lower doses.

Respiratory, thoracic and mediastinal disorders

Uncommon: Dyspnoea.

Gastrointestinal disorders

Rare: Abdominal discomfort, vomiting, diarrhoea.

Hepato-biliary disorders

Very rare: Reversible increases in liver function tests, which are occasionally described as hepatitis.

Skin and subcutaneous tissue disorders

Uncommon: Rashes including photosensitivity.

Rare: Pruritus.

Very rare: Urticaria, angioedema.

Renal and urinary disorders

Rare: Renal impairment.

Very rare: Acute renal failure.

Other adverse reactions

There have been reports of renal impairment, microangiopathic haemolytic anaemia and thrombocytopenia (sometimes in combination) in severely immunocompromised patients, particularly those with advanced HIV disease, receiving high doses (8 g daily) of valaciclovir for prolonged periods. These findings have also been observed in patients not treated with valaciclovir who have the same underlying or concurrent conditions.

4.9 Overdose

There is limited data available on overdosage with valaciclovir. However patients have ingested single overdoses of up to 20 g of aciclovir, which is only partially absorbed in the gastrointestinal tract, usually without toxic effects. Accidental, repeated overdoses of oral aciclovir over several days have been associated with gastrointestinal effects (such as nausea and vomiting) and neurological effects (headache and confusion). Overdosage of intravenous aciclovir has resulted in elevations of serum creatinine and subsequent renal failure. Neurological effects including confusion, hallucinations, agitation, seizures and coma have been described in association with intravenous overdosage.

Haemodialysis significantly enhances the removal of aciclovir from the blood and may, therefore, be considered a management option in the event of overdose.

5. Pharmacological Properties

5.1 Pharmacodynamic Properties

Pharmacotherapeutic group: Nucleosides and nucleotides excl. reverse transcriptase inhibitors,

ATC code: J 05 A B 11

Valaciclovir is the L-valine ester of aciclovir. Aciclovir is a guanine nucleoside analogue.

Following absorption valaciclovir is rapidly and almost completely converted to aciclovir and valine, probably by the enzyme referred to as valaciclovir hydrolase.

Aciclovir is a specific inhibitor of the herpes viruses with in vitro activity against herpes simplex viruses (HSV) type 1 and type 2, varicella zoster virus (VZV), cytomegalovirus (CMV), Epstein-Barr Virus (EBV), and human herpes virus 6 (HHV-6). Aciclovir inhibits herpes virus DNA synthesis once it has been phosphorylated to the active triphosphate form.

The first stage of phosphorylation requires the activity of a virus-specific enzyme. In the case of HSV, VZV and EBV this enzyme is the viral thymidine kinase, which is only present in virus infected cells. Selectivity is maintained in CMV with phosphorylation, at least in part, being mediated through the phosphotransferase gene product of UL97. This requirement for activation of aciclovir by a virus specific enzyme largely explains its selectivity.

The phosphorylation process is completed (conversion from mono- to triphosphate) by cellular kinases. Aciclovir triphosphate competitively inhibits the virus DNA polymerase and incorporation of this nucleoside analogue results in obligate chain termination, halting virus DNA synthesis and thus blocking virus replication.

Extensive monitoring of clinical HSV and VZV isolates from patients receiving aciclovir therapy or prophylaxis has revealed that virus with reduced sensitivity to aciclovir is extremely rare in the immunocompetent and is only found infrequently in severely immunocompromised individuals e.g. organ or bone marrow transplant recipients, patients receiving chemotherapy for malignant disease and people infected with the human immunodeficiency virus (HIV).

Resistance is normally due to a thymidine kinase deficient phenotype which results in a virus which is profoundly disadvantaged in the natural host. Infrequently, reduced sensitivity to aciclovir has been described as a result of subtle alterations in either the virus thymidine kinase or DNA polymerase. The virulence of these variants resembles that of the wild-type virus.

5.2 Pharmacokinetic Properties

General characteristics:

After oral administration valaciclovir is well absorbed and rapidly and almost completely converted to aciclovir and valine. This conversion is probably mediated by an enzyme isolated from human liver referred to as valaciclovir hydrolase.

The bioavailability of aciclovir from 1000 mg valaciclovir is 54%, and is not reduced by food. Mean peak aciclovir concentrations are 10-37 microM (2.2-8.3mcg/ml) following single doses of 250-2000 mg valaciclovir to healthy subjects with normal renal function, and occur at a mean time of 1.00-2.00 hours post dose.

Peak plasma concentrations of valaciclovir are only 4% of aciclovir levels, occur at a mean time of 30 to 100 minutes post dose, and are at or below the limit of quantification 3 hours after dosing. The valaciclovir and aciclovir pharmacokinetic profiles are similar after single and repeat dosing. Binding of valaciclovir to plasma proteins is very low (15%).

In patients with normal renal function the plasma elimination half-life of aciclovir after both single and multiple dosing with valaciclovir is approximately 3 hours. In patients with end-stage renal disease, the average elimination half-life of aciclovir after valaciclovir administration is approximately 14 hours. Less than 1% of the administered dose of valaciclovir is recovered in the urine as unchanged drug. Valaciclovir is excreted in the urine principally as aciclovir (greater than 80% of the recovered dose) and the known aciclovir metabolite, 9-(carboxymethoxy)methylguanine (CMMG).

Characteristics in patients:

Herpes zoster and herpes simplex do not significantly alter the pharmacokinetics of valaciclovir and aciclovir after oral administration of valaciclovir.

In a study of the pharmacokinetics of valaciclovir and aciclovir during late pregnancy, the daily aciclovir AUC (area under plasma concentration-time curve) following valaciclovir 1000 mg was approximately 2 times greater than that observed with oral aciclovir at 1200 mg daily.

In patients with HIV infection, the disposition and pharmacokinetic characteristics of aciclovir after oral administration of single or multiple doses of valaciclovir 1000 mg or 2000 mg are unaltered compared with healthy subjects.

In transplant recipients receiving valaciclovir 2000 mg 4 times daily, aciclovir peak concentrations are similar to or greater than those in healthy volunteers receiving the same dose. The estimated daily AUCs are appreciably greater.

5.3 Preclinical Safety Data

Mutagenicity:

The results of mutagenicity tests in vitro and in vivo indicate that valaciclovir is unlikely to pose a genetic risk to humans.

Carcinogenicity:

Valaciclovir was not carcinogenic in studies performed in mice and rats.

Teratogenicity

Valaciclovir was not teratogenic in rats and rabbits. Valaciclovir is almost completely metabolised to aciclovir. Experiments with subcutaneous administration of aciclovir did not produce teratogenic effects in rats and rabbits. In additional studies in rats, foetal abnormalities were observed at subcutaneous doses that produced plasma levels of 100 mcg/ml and maternal toxicity.

Fertility

Oral valaciclovir did not affect fertility in male or female rats.

6. Pharmaceutical Particulars

6.1 List Of Excipients

Tablet core

Calcium hydrogen phosphate (dehydrate), sodium starch glycolate, hydroxy prophyl cellulose, talcum, magnesium stearate.

Film-coat

Hypromellose, lactose (monohydrate), titanium dioxide (E171), macrogol 4000

6.2 Incompatibilities

Not applicable.

6.3 Shelf Life

36 months

6.4 Special Precautions For Storage

Store below 30°C.

6.5 Nature And Contents Of Container

PVC/PE/PVDC/aluminium blister packs:

Pack sizes:

10 tablets, 40 tablets or 42 tablets.

6.6 Special Precautions For Disposal And Other Handling

No special requirements.

7. Marketing Authorisation Holder

Beacon Pharmaceuticals Ltd., 85 High St., Tunbridge Wells, TN1 1YG, UK.

8. Marketing Authorisation Number(S)

PL 18157/0226

9. Date Of First Authorisation/Renewal Of The Authorisation

22/01/2010

10. Date Of Revision Of The Text

22/01/2010

Simply Stuffy

Generic Name: pseudoephedrine (Oral route)

soo-doe-e-FED-rin

Commonly used brand name(s)

In the U.S.

12 Hour Cold Maximum Strength

Biofed

Cenafed

Chlor-Trimeton Nasal Decongestant

Contac 12-Hour

Dimetapp Decongestant

Efidac 24 Pseudoephedrine

ElixSure Congestion Children's

Genaphed

Pediacare Decongestant Infants

Simply Stuffy

Sudafed

Available Dosage Forms:

Capsule, Extended Release

Tablet, Chewable

Tablet, Extended Release

Solution

Syrup

Liquid

Tablet

Capsule

Capsule, Liquid Filled

Suspension

Therapeutic Class: Decongestant

Pharmacologic Class: Alpha-Adrenergic Agonist

Uses For Simply Stuffy

Pseudoephedrine is used to relieve nasal or sinus congestion caused by the common cold, sinusitis, and hay fever and other respiratory allergies. It is also used to relieve ear congestion caused by ear inflammation or infection.

Some of these preparations are available only with your doctor's prescription.

Do not give any over-the-counter (OTC) cough and cold medicine to a baby or child under 4 years of age. Using these medicines in very young children might cause serious or possibly life-threatening side effects .

Before Using Simply Stuffy

Allergies

Pediatric

Pseudoephedrine may be more likely to cause side effects in infants, especially newborn and premature infants, than in older children and adults.

Geriatric

Many medicines have not been studied specifically in older people. Therefore, it may not be known whether they work exactly the same way they do in younger adults or if they cause different side effects or problems in older people. There is no specific information comparing use of pseudoephedrine in the elderly with use in other age groups.

Breast Feeding

Studies in women suggest that this medication poses minimal risk to the infant when used during breastfeeding.

Interactions with Medicines

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

Clorgyline

Dihydroergotamine

Furazolidone

Iproniazid

Isocarboxazid

Linezolid

Moclobemide

Nialamide

Pargyline

Phenelzine

Procarbazine

Rasagiline

Selegiline

Toloxatone

Tranylcypromine

Guanethidine

Methyldopa

Midodrine

Interactions with Food/Tobacco/Alcohol

Proper Use of pseudoephedrine

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

For patients taking pseudoephedrine extended-release capsules:

Swallow the capsule whole. However, if the capsule is too large to swallow, you may mix the contents of the capsule with jam or jelly and swallow without chewing.

Do not crush or chew before swallowing.

For patients taking pseudoephedrine extended-release tablets:

Swallow the tablet whole.

Do not break, crush, or chew before swallowing.

To help prevent trouble in sleeping, take the last dose of pseudoephedrine for each day a few hours before bedtime. If you have any questions about this, check with your doctor.

Take this medicine only as directed. Do not take more of it, do not take it more often, and do not take it for a longer period of time than recommended on the label (usually 7 days), unless otherwise directed by your doctor. To do so may increase the chance of side effects.

Dosing

For nasal or sinus congestion:
- For regular (short-acting) oral dosage form (capsules, oral solution, syrup, or tablets):
  - Adults and children 12 years of age and older—60 milligrams (mg) every four to six hours. Do not take more than 240 mg in twenty-four hours.
  - Children 6 to 12 years of age—30 mg every four to six hours. Do not take more than 120 mg in twenty-four hours.
  - Children 4 to 6 years of age—15 mg every four to six hours. Do not take more than 60 mg in twenty-four hours.
  - Children and infants up to 4 years of age—Use is not recommended .
- For long-acting oral dosage form (extended-release capsules or extended-release tablets):
  - Adults and children 12 years of age and older—120 mg every 12 hours, or 240 mg every 24 hours. Do not take more than 240 mg in 24 hours.
  - Infants and children up to 12 years of age—Use is not recommended .

Missed Dose

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

Storage

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

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Precautions While Using Simply Stuffy

If symptoms do not improve within 7 days or if you also have a high fever, check with your doctor since these signs may mean that you have other medical problems.

Simply Stuffy 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 - more common with high doses

Convulsions (seizures)

hallucinations (seeing, hearing, or feeling things that are not there)

irregular or slow heartbeat

shortness of breath or troubled breathing

Symptoms of overdose

Convulsions (seizures)

fast breathing

hallucinations (seeing, hearing, or feeling things that are not there)

increase in blood pressure

irregular heartbeat (continuing)

shortness of breath or troubled breathing (severe or continuing)

slow or fast heartbeat (severe or continuing)

unusual nervousness, restlessness, or excitement

More common

Nervousness

restlessness

trouble in sleeping

Less common

Difficult or painful urination

dizziness or light-headedness

fast or pounding heartbeat

headache

increased sweating

nausea or vomiting

trembling

unusual paleness

weakness

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

See also: Simply Stuffy side effects (in more detail)

More Simply Stuffy resources

Simply Stuffy Side Effects (in more detail)
Simply Stuffy Use in Pregnancy & Breastfeeding
Drug Images
Simply Stuffy Drug Interactions
Simply Stuffy Support Group
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Nasal Congestion

Wednesday, 28 December 2011

Diltiazem Clorhidrato Genfar

Diltiazem Clorhidrato Genfar may be available in the countries listed below.

Ingredient matches for Diltiazem Clorhidrato Genfar

Diltiazem

Diltiazem hydrochloride (a derivative of Diltiazem) is reported as an ingredient of Diltiazem Clorhidrato Genfar in the following countries:

Chile

International Drug Name Search

Friday, 23 December 2011

Demethylchlortetracycline Hydrochloride

Demethylchlortetracycline Hydrochloride may be available in the countries listed below.

Ingredient matches for Demethylchlortetracycline Hydrochloride

Demeclocycline

Demethylchlortetracycline Hydrochloride (JAN) is known as Demeclocycline in the US.

International Drug Name Search

Glossary

JAN

Japanese Accepted Name

Click for further information on drug naming conventions and International Nonproprietary Names.

Sunday, 4 March 2012

Commonly used brand name(s)

Uses For Freezone

Before Using Freezone

Allergies

Pediatric

Geriatric

Breast Feeding

Interactions with Medicines

Interactions with Food/Tobacco/Alcohol

Other Medical Problems

Proper Use of salicylic acid

Dosing

Missed Dose

Storage

Precautions While Using Freezone

Freezone Side Effects

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Vicks VapoSteam Liquid is used for:

Do NOT use Vicks VapoSteam Liquid if:

Before using Vicks VapoSteam Liquid:

How to use Vicks VapoSteam Liquid:

Important safety information:

Possible side effects of Vicks VapoSteam Liquid:

If OVERDOSE is suspected:

General information:

More Vicks VapoSteam resources

Saturday, 3 March 2012

Commonly used brand name(s)

Uses For immune globulin

Before Using immune globulin

Allergies

Pediatric

Geriatric

Pregnancy

Breast Feeding

Interactions with Medicines

Interactions with Food/Tobacco/Alcohol

Other Medical Problems

Proper Use of immune globulin

Missed Dose

Storage

Precautions While Using immune globulin

immune globulin Side Effects

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1. Name Of The Medicinal Product

2. Qualitative And Quantitative Composition

3. Pharmaceutical Form

4. Clinical Particulars

4.1 Therapeutic Indications

4.2 Posology And Method Of Administration

4.3 Contraindications

4.4 Special Warnings And Precautions For Use

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

4.6 Pregnancy And Lactation

4.7 Effects On Ability To Drive And Use Machines

4.8 Undesirable Effects

4.9 Overdose

5. Pharmacological Properties

5.1 Pharmacodynamic Properties

5.2 Pharmacokinetic Properties

5.3 Preclinical Safety Data

6. Pharmaceutical Particulars

6.1 List Of Excipients

6.2 Incompatibilities

6.3 Shelf Life

6.4 Special Precautions For Storage

6.5 Nature And Contents Of Container

6.6 Special Precautions For Disposal And Other Handling

7. Marketing Authorisation Holder

8. Marketing Authorisation Number(S)

9. Date Of First Authorisation/Renewal Of The Authorisation

10. Date Of Revision Of The Text

Commonly used brand name(s)

Uses For Simply Stuffy

Before Using Simply Stuffy

Allergies

Pediatric