Summer's Eve Specialcare

Generic Name: hydrocortisone (Topical application route)

hye-droe-KOR-ti-sone

Commonly used brand name(s)

In the U.S.

• Ala-Cort


• Ala-Scalp HP


• Anusol HC


• Aquanil HC


• Beta HC


• Caldecort


• Cetacort


• Corta-Cap


• Cortagel Extra Strength


• Cortaid


• CortAlo With Aloe


• Corticaine


• Corticool Maximum Strength


• Cortizone-10


• Cortizone-5


• Cotacort


• Delacort


• Dermarest


• Dermtex-HC


• Foille Cort


• Gly-Cort


• Hydrozone Plus


• Hytone


• Instacort-10


• Ivy Soothe


• IvyStat


• Keratol HC


• Kericort 10


• Lacticare-HC


• Locoid


• Locoid Lipocream


• Medi-Cortisone Maximum Strength


• Microcort


• Mycin Scalp


• Neutrogena T/Scalp


• NuCort


• Nupercainal HC


• Nutracort


• Pandel


• Pediaderm HC Kit


• Preparation H Hydrocortisone


• Proctocream-HC


• Recort Plus


• Sarnol-HC Maximum Strength


• Scalacort


• Scalpcort


• Summer's Eve Specialcare


• Texacort


• Therasoft Anti-Itch & Dermatitis


• U-Cort


• Westcort

In Canada

• Barriere-Hc


• Cortate


• Cort-Eze


• Cortoderm Mild Ointment


• Cortoderm Regular Ointment


• Emo-Cort


• Emo-Cort Scalp Solution


• Hydrocortisone Cream


• Novo-Hydrocort


• Novo-Hydrocort Cream


• Prevex Hc


• Sarna Hc

Available Dosage Forms:

• Solution


• Cream


• Spray


• Lotion


• Ointment


• Pad


• Liquid


• Gel/Jelly


• Kit


• Foam


• Stick


• Paste

Therapeutic Class: Corticosteroid, Weak

Pharmacologic Class: Adrenal Glucocorticoid

Uses For Summer's Eve Specialcare

Hydrocortisone topical is used to help relieve redness, itching, swelling, or other discomfort caused by skin conditions. This medicine is a corticosteroid (cortisone-like medicine or steroid).

This medicine is available both over-the-counter (OTC) and with your doctor's prescription.

Before Using Summer's Eve Specialcare

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

Allergies

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

Pediatric

Appropriate studies performed to date have not demonstrated pediatric-specific problems that would limit the usefulness of hydrocortisone topical in the pediatric population. However, because of this medicine's toxicity, it should be used with caution. Children may absorb large amounts through the skin, which can cause serious side effects. If your child is using this medicine, follow your doctor's instructions very carefully.

Geriatric

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

Interactions with Medicines

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

Interactions with Food/Tobacco/Alcohol

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

Other Medical Problems

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

• Cushing's syndrome (adrenal gland disorder) or


• Diabetes or


• Hyperglycemia (high blood sugar) or


• Intracranial hypertension (increased pressure in the head)—Use with caution. May make these conditions worse.

• Infection of the skin at or near the place of application or


• Large sores, broken skin, or severe skin injury at the place of application—The chance of side effects may be increased.

Proper Use of hydrocortisone

This section provides information on the proper use of a number of products that contain hydrocortisone. It may not be specific to Summer's Eve Specialcare. Please read with care.

It is very important that you use this medicine only as directed by your doctor. Do not use more of it, do not use it more often, and do not use it for a longer time than your doctor ordered. To do so may cause unwanted side effects or skin irritation.

This medicine is for use on the skin only. Do not get it in your eyes. Do not use it on skin areas that have cuts, scrapes, or burns. If it does get on these areas, rinse it off right away with water.

This medicine should only be used for skin conditions that your doctor is treating. Check with your doctor before using it for other conditions, especially if you think that a skin infection may be present. This medicine should not be used to treat certain kinds of skin infections or conditions, such as severe burns.

To use:

• Wash your hands with soap and water before and after using this medicine.


• Apply a thin layer of this medicine to the affected area of the skin. Rub it in gently.


• With the lotion, shake it well before using.


• Do not bandage or otherwise wrap the skin being treated unless directed to do so by your doctor.


• If the medicine is applied to the diaper area of an infant, do not use tight-fitting diapers or plastic pants unless directed to do so by your doctor.


• If your doctor ordered an occlusive dressing or airtight covering to be applied over the medicine, make sure you know how to apply it. Occlusive dressings increase the amount of medicine absorbed through your skin, so use them only as directed. If you have any questions about this, check with your doctor.

Dosing

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

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 redness, itching, and swelling of the skin:
  
  • For topical dosage form (cream):
    
    • Adults—Apply to the affected area of the skin two or three times per day.
    
    
    • Children—Apply to the affected area of the skin two or three times per day.
    
    
  
  
  • For topical dosage form (lotion):
    
    • Adults—Apply to the affected area of the skin two to four times per day.
    
    
    • Children—Apply to the affected area of the skin two to four times per day.
    
    
  
  
  • For topical dosage form (ointment):
    
    • Adults—Apply to the affected area of the skin three or four times per day.
    
    
    • Children—Apply to the affected area of the skin three or four times per day.
    
    
  
  
  • For topical dosage form (solution):
    
    • Adults—Apply to the affected area of the skin three or four times per day.
    
    
    • Children—Apply to the affected area of the skin three or four times per 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.

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

Precautions While Using Summer's Eve Specialcare

It is very important that your doctor check your or your child's progress at regular visits for any unwanted effects that may be caused by this medicine.

If your or your child's symptoms do not improve within a few days, or if they become worse, check with your doctor.

Using too much of this medicine or using it for a long time may increase your risk of having adrenal gland problems. The risk is greater for children and patients who use large amounts for a long time. Talk to your doctor right away if you or your child have more than one of these symptoms while you are using this medicine: blurred vision; dizziness or fainting; a fast, irregular, or pounding heartbeat; increased thirst or urination; irritability; or unusual tiredness or weakness.

Stop using this medicine and check with your doctor right away if you or your child have a skin rash, burning, stinging, swelling, or irritation on the skin.

Do not use cosmetics or other skin care products on the treated areas.

Summer's Eve Specialcare Side Effects

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

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

Incidence not known

• Blistering, burning, crusting, dryness, or flaking of the skin


• irritation


• itching, scaling, severe redness, soreness, or swelling of the skin


• redness and scaling around the mouth


• thinning of the skin with easy bruising, especially when used on the face or where the skin folds together (e.g. between the fingers)


• thinning, weakness, or wasting away of the skin

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

Incidence not known

• Acne or pimples


• burning and itching of the skin with pinhead-sized red blisters


• burning, itching, and pain in hairy areas, or pus at the root of the hair


• increased hair growth on the forehead, back, arms, and legs


• lightening of normal skin color


• lightening of treated areas of dark skin


• reddish purple lines on the arms, face, legs, trunk, or groin


• softening of the skin

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 Summer's Eve Specialcare resources

• Summer's Eve Specialcare Use in Pregnancy & Breastfeeding
• Summer's Eve Specialcare Drug Interactions
• Summer's Eve Specialcare Support Group
• 15 Reviews for Summer's Eve Specialcare - Add your own review/rating

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• Aphthous Stomatitis, Recurrent
• Atopic Dermatitis
• Dermatitis
• Eczema
• Gingivitis
• Hemorrhoids
• Proctitis
• Pruritus
• Psoriasis
• Seborrheic Dermatitis
• Skin Rash
• Ulcerative Colitis, Active

Pancof EXP Syrup

Pronunciation: dye-hye-droe-KOE-deen/gwye-FEN-e-sin /sue-doe-eh-FED-rin
Generic Name: Dihydrocodeine/Guaifenesin/Pseudoephedrine
Brand Name: Examples include Hydro-Tussin EXP and Pancof EXP

Pancof EXP Syrup is 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.

Pancof EXP Syrup is a decongestant, cough suppressant, and expectorant combination. It works by constricting blood vessels and reducing swelling in the nasal passages, loosening mucus and lung secretions in the chest, and making coughs more productive. The cough suppressant works in the brain to help decrease the cough reflex to reduce a dry cough.

Do NOT use Pancof EXP Syrup if:

• you are allergic to any ingredient in Pancof EXP Syrup or any other codeine or morphine related medicine (eg, oxycodone)


• you have severe high blood pressure, a rapid heartbeat, other severe heart problems (eg, heart blood vessel disease), severe bowel problems (eg, paralytic ileus), severe asthma, or you are having an asthma attack


• you are taking sodium oxybate (GHB) or 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 Pancof EXP Syrup:

Some medical conditions may interact with Pancof EXP Syrup. 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 had a severe allergic reaction (eg, severe rash, hives, difficulty breathing, dizziness) to morphine, codeine, or any other opiate (eg, hydrocodone, dihydrocodeine, oxycodone)


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


• if you have a history of stomach problems, bowel problems (eg, chronic inflammation or ulceration of the bowel), gallbladder problems (eg, gallstones), a blockage of your bladder or bowel, kidney or liver problems, or if you have had recent abdominal surgery


• if you have a history of asthma, chronic cough, lung problems (eg, chronic bronchitis, emphysema), or chronic obstructive pulmonary disease (COPD), or if your cough occurs with large amounts of mucus


• if you have recently had any head injury, brain injury or tumor, increased pressure in the brain, infection of the brain or nervous system, epilepsy, or seizures


• if you have a history of alcohol abuse, drug abuse, or suicidal thoughts or behavior

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

• Beta-blockers (eg, propranolol), catechol-O-methyltransferase (COMT) inhibitors (eg, tolcapone), cimetidine, furazolidone, HIV protease inhibitors (eg, ritonavir), indomethacin, MAO inhibitors (eg, phenelzine), or tricyclic antidepressants (eg, amitriptyline) because the risk of side effects from Pancof EXP Syrup may be increased


• Digoxin, droxidopa, or sodium oxybate (GHB) because the risk of severe drowsiness, breathing problems, seizures, irregular heartbeat, or heart attack may be increased


• Naltrexone and quinidine because the effectiveness of Pancof EXP Syrup may be decreased.


• Bromocriptine because the risk of side effects may be increased by Pancof EXP Syrup


• Guanadrel, guanethidine, mecamylamine, methyldopa, or reserpine because effectiveness may be decreased by Pancof EXP Syrup

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

Use Pancof EXP Syrup as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• Take Pancof EXP Syrup by mouth with or without food.


• Drink plenty of water while taking Pancof EXP Syrup.


• Use a measuring device marked for medicine dosing. Ask your pharmacist for help if you are unsure of how to measure your dose.


• If you miss a dose of Pancof EXP Syrup, 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 Pancof EXP Syrup.

Important safety information:

• Pancof EXP Syrup may cause drowsiness or dizziness. These effects may be worse if you take it with alcohol or certain medicines. Use Pancof EXP Syrup 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 Pancof EXP Syrup without checking with your doctor.


• Pancof EXP Syrup 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.


• Pancof EXP Syrup may interfere with certain lab tests. Be sure your doctor and lab personnel know you are taking Pancof EXP Syrup.


• Tell your doctor or dentist that you take Pancof EXP Syrup before you receive any medical or dental care, emergency care, or surgery.


• Use Pancof EXP Syrup with caution in the ELDERLY; they may be more sensitive to its effects.


• Pancof EXP Syrup should not be used in CHILDREN younger than 2 years old; 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 Pancof EXP Syrup while you are pregnant. It is not known if Pancof EXP Syrup is found in breast milk. Do not breast-feed while taking Pancof EXP Syrup.

Possible side effects of Pancof EXP Syrup:

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; drowsiness; 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; severe drowsiness; 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: Pancof EXP 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 Pancof EXP Syrup:

Store Pancof EXP Syrup 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 Pancof EXP Syrup out of the reach of children and away from pets.

General information:

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


• Pancof EXP Syrup 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 Pancof EXP Syrup. 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 Pancof EXP resources

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

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Conivaptan

Pronunciation: KOE-ni-VAP-tan
Generic Name: Conivaptan
Brand Name: Vaprisol

Conivaptan is used for:

Treating low blood sodium levels in certain patients.

Conivaptan is an arginine vasopressin receptor antagonist. It works by increasing fluid removal from the body, which helps to normalize blood sodium levels.

Do NOT use Conivaptan if:

• you are allergic to any ingredient in Conivaptan or to corn or corn products


• you have low blood sodium levels along with low blood or fluid volume


• you have severe kidney problems or you are not able to urinate


• you are taking certain azole antifungals (eg, ketoconazole, itraconazole), an HIV protease inhibitor (eg, indinavir, ritonavir), certain macrolide antibiotics (eg, clarithromycin), nefazodone, or telithromycin

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

Before using Conivaptan:

Some medical conditions may interact with Conivaptan. 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 congestive heart failure, liver problems, or kidney problems


• if you have poor nutrition or you have an alcohol addiction

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

• Azole antifungals (eg, itraconazole, ketoconazole), HIV protease inhibitors (eg, indinavir, ritonavir), macrolides (eg, clarithromycin), nefazodone, or telithromycin because they may increase the risk of Conivaptan's side effects


• Amlodipine, benzodiazepines (eg, alprazolam, midazolam), or digoxin because the risk of their side effects may be increased by Conivaptan


• HMG-CoA reductase inhibitors (eg, atorvastatin) because the risk of serious muscle problems may be increased

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

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

• Conivaptan is given as an injection at your doctor's office, hospital, or clinic.


• Do not use Conivaptan if it contains particles, is cloudy or discolored, or if the container is cracked or damaged.


• If you miss a dose of Conivaptan, contact your doctor right away.

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

Important safety information:

• Conivaptan may cause dizziness. This effect may be worse if you take it with alcohol or certain medicines. Use Conivaptan with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.


• Conivaptan may cause dizziness, lightheadedness, or fainting; alcohol, hot weather, exercise, or fever may increase these effects. To prevent them, sit up or stand slowly, especially in the morning. Sit or lie down at the first sign of any of these effects.


• Severe side effects may occur if your blood sodium levels rise too quickly. Contact your doctor right away if you develop abnormal speech (eg, you are unable to speak), trouble swallowing, mental or mood changes, seizures, sluggishness, or weakness in the arms and legs.


• Diabetes patients - Conivaptan may affect your blood sugar. Check blood sugar levels closely. Ask your doctor before you change the dose of your diabetes medicine.


• Lab tests, including blood sodium levels and neurologic tests, may be performed while you use Conivaptan. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.


• Conivaptan should be used with extreme caution in CHILDREN; safety and effectiveness in children have not been confirmed.


• PREGNANCY and BREAST-FEEDING: Conivaptan may cause harm to the fetus. If you think you may be pregnant, contact your doctor. You will need to discuss the benefits and risks of using Conivaptan while you are pregnant. It is not known if Conivaptan is found in breast milk. Do not breast-feed while taking Conivaptan.

Possible side effects of Conivaptan:

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:

Constipation; diarrhea; dry mouth; headache; increased thirst; nausea; trouble sleeping; vomiting.

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); blood in the urine; confusion; drowsiness; fast or irregular heartbeat; fever; increased or painful urination; increased sweating; mental or mood changes; muscle pain, weakness, or cramping; pain, irritation, redness, or swelling at the injection site; rapid breathing; severe or persistent dizziness; severe or persistent increase in thirst; tremor; unusual tiredness or weakness; white patches in the mouth.

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: Conivaptan 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 (http://www.aapcc.org ), or emergency room immediately. Symptoms may include fainting; severe or persistent dizziness; severe or persistent increase in thirst.

Proper storage of Conivaptan:

Conivaptan is usually handled and stored by a health care provider. If you are using Conivaptan at home, store Conivaptan as directed by your pharmacist or health care provider. Keep Conivaptan out of the reach of children and away from pets.

General information:

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


• Conivaptan 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 Conivaptan. 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 Conivaptan resources

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

• conivaptan Intravenous Advanced Consumer (Micromedex) - Includes Dosage Information


• Conivaptan Hydrochloride Monograph (AHFS DI)


• Vaprisol Prescribing Information (FDA)


• Vaprisol Consumer Overview

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Codipar 15mg / 500mg Effervescent Tablets

1. Name Of The Medicinal Product

Codipar 15mg/500mg Effervescent Tablets

2. Qualitative And Quantitative Composition

Each tablet contains Codeine Phosphate hemihydrate 15mg.and Paracetamol 500mg,

Excipients: Each tablet also contains 389mg of sorbitol and 379 mg of sodium.

For a full list of excipients, see 6.1.

3. Pharmaceutical Form

Effervescent Tablet

Bevelled, flat, round, white tablet

4. Clinical Particulars

4.1 Therapeutic Indications

For the relief of mild to severe acute pain

4.2 Posology And Method Of Administration

Method of administration: Oral

The tablets should be placed in a glass of water and allowed to be dissolved completely. The resulting solution should be drunk immediately.

Adults: The usual dose is two tablets every four hours as required. The total daily dose should not exceed 4 g paracetamol (8 tablets in a day).

Elderly; As for adults, however a reduced dose may be required (see section 4.4)

Paediatric population: Not recommended in children below the age of 18 years (see section 5.1).

4.3 Contraindications

Hypersensitivity to either paracetamol or codeine, or any of the excipients of Codipar tablets.

Conditions where morphine and opioids are contraindicated e.g., acute asthma, respiratory depression, acute alcoholism, head injuries, raised intra-cranial pressure and following biliary tract surgery; monoamine oxidase inhibitor therapy, concurrent or within 14 days.

Codipar is also contraindicated in severe liver disease and severe renal impairment. The hazards of overdose could be greater in those with alcoholic liver disease.

Use of codeine containing products is contraindicated in mothers who are breastfeeding unless prescribed by a doctor (see section 4.6).

4.4 Special Warnings And Precautions For Use

Care should be observed in administering the product to any patient whose condition may be exacerbated by opioids, including the elderly, who may be sensitive to their central and gastro-intestinal effects, those on concurrent CNS depressant drugs, those with prostatic hypertrophy / urethral stricture and those with inflammatory or obstructive bowel disorders. Care should also be observed if prolonged therapy is contemplated, since side effects are more frequent and may lead to intolerance of the product with regular, long-term use.

Codeine at high doses has the same disadvantages as morphine, including respiratory depression. Drug dependence of the morphine type can be produced by codeine, and the potential for drug abuse with codeine must be considered. Codeine may impair mental or physical abilities required in the performance of potentially hazardous tasks.

Prolonged regular use, except under medical supervision, may lead to physical and psychological dependence (addiction) and result in withdrawal symptoms such as restlessness and irritability, once the drug is stopped.

Care should be taken in patients with liver and kidney disease with suitable dose reductions as appropriate.

Prolonged use except on the doctor's advice may be harmful.

This product should be used only when clearly necessary.

Immediate medical advice should be sought in the event of overdosage, even if the patient feels well, because of the risk of irreversible liver damage.

Patients must be advised not to exceed the recommended dose and not to take other paracetamol containing products concurrently.

The risk-benefit of continued use should be assessed regularly by the prescriber.

Patients must be advised not to take other products containing paracetamol or opiate derivatives when taking Codipar, and to consult their doctor if symptoms persist.

The cough suppressant effect of codeine may be undesirable in patients with some respiratory conditions.

As the effervescent tablet contains 389mg of sorbitol, patients with rare hereditary problems of fructose intolerance should not take this medicine

This medicine contains 379 mg sodium in each tablet. This should be taken into consideration by patients on a controlled sodium (salt) diet.

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

The hypotensive effects of antihypertensive agents, including diuretics, may be potentiated by codeine.

The CNS depressant action of Codipar may be enhanced by coadministration with any other drug which has a CNS depressant effect (e.g. anxiolytics, hypnotics, antidepressants, antipsychotics and alcohol). Concomitant use of any drug with a CNS depressant action should be avoided. If combined therapy is necessary, the dose of one or both agents should be reduced.

Concomitant administration of Codipar and MAOIs or tricyclic antidepressants may increase the effect of either the antidepressant or codeine.

Concomitant administration of codeine and anticholinergics may cause paralytic ileus.

Concomitant administration of codeine with an anti-diarrhoeal agent increases the risk of severe constipation, and coadministration with an antimuscarinic drug may cause urinary retention.

The absorption of paracetamol may be enhanced by metoclopramide or domperidone, and absorption may be reduced by cholestyramine.

The metabolism of paracetamol is increased in patients taking enzyme-inducing antiepileptics (carbamazepine, phenytoin, phenobarbital, primidone). Isolated reports describe unexpected hepatotoxicity in patients taking phenobarbital, phenytoin, or carbamazepine after taking paracetamol.

The anticoagulant effect of warfarin and other coumarins may be increased by long term regular daily use of paracetamol, with increased risk of bleeding. Occasional doses of paracetamol do not have a significant effect on these anticoagulants.

Dependence of codeine hypoalgesia on morphine formation via CYP2D6 makes this effect liable to interaction with drugs that are inhibitors of CYP2D6. Examples of potent inhibitors of CYP2D6 are quinidine, some selective serotonin reuptake inhibitors, some neuroleptics and ritornavir.

Codeine may delay the absorption of mexilitine

4.6 Pregnancy And Lactation

Pregnancy: On the basis of published literature (Danish National Birth Cohort), paracetamol use during any time of pregnancy was associated with a small but statistically significant increased risk of physician-diagnosed asthma or bronchitis among children at 18 months.

Use of codeine during pregnancy may lead to withdrawal symptoms in neonates, and use during labour may cause neonatal respiratory depression.

Codipar is then not recommended during pregnancy.

Lactation: Codeine is excreted in the human milk. The decision to use codeine in nursing women should be based on clinical judgment. If used in such patients, codeine should be administered in the lowest effective dosage for the shortest possible time.

In nursing mothers, who are ultra-rapid metabolisers of codeine, higher than expected serum and breast milk morphine levels can occur. Morphine toxicity in babies can cause excessive somnolence, hypotonia, miosis and difficulty breastfeeding or breathing. In severe cases respiratory depression and death can occur. In severe cases, naloxone may be appropriate to reverse the effects. The lowest effective dose should be used, for the shortest possible time.

Nursing mothers should be informed about carefully monitoring the infant during treatment for any signs and/or symptoms of morphine toxicity such as increased drowsiness or sedation, difficulty breastfeeding, breathing difficulties, miosis and decreased tone, and seeking immediate medical care if such symptoms or signs are noticed. The nursing mother should be informed about monitoring for signs and symptoms of maternal opioid toxicity as well. Should such signs/symptoms be noted in mother or baby, the mother should immediately stop taking all codeine-containing medicines and seek medical advice.

Paracetamol is distributed in human milk, although its concentration is 20% lower than in plasma. For these reasons, Codipar should be avoided during breast-feeding.

4.7 Effects On Ability To Drive And Use Machines

Patients should be advised not to drive or operate machinery if Codipar causes dizziness or sedation. Codeine may cause visual disturbances.

4.8 Undesirable Effects

Reported adverse reactions seem more prominent in ambulatory than non-ambulatory patients and some of these effects may be alleviated if the patient lies down.

The most commonly (>1/100, <1/10) reported reactions are:

Central nervous system:	Dizziness Light-headedness Sedation Headache
Gastro-Intestinal:	Nausea & vomiting Constipation Abdominal pain
Psychiatric:	Dysphoria Euphoria
Respiratory:	Shortness of breath
Skin:	Pruritus Rash Urticaria

In clinical use of paracetamol-containing products, blood dyscrasias (including thrombocytopenia and agranulocytosis) are reported rarely (>1/10000, <1/1000).

Also, rarely hypersensitivity including skin rash may occur with paracetamol use. _

The frequencies of the following side effects are not known or cannot be estimated from the data available:

Eye disorders: Miosis

Renal and urinary disorders: Urinary retention

Codeine can cause respiratory depression particularly in overdosage and in patients with compromised respiratory function (see Section 4.9).

Liver damage in association with therapeutic use of paracetamol has been documented; most cases have occurred in conjunction with chronic alcohol abuse.

Regular prolonged use of codeine is known to lead to addiction and symptoms of restlessness and irritability may result when treatment is then stopped.

4.9 Overdose

Codeine

Large doses of codeine produce respiratory depression and hypotension, with circulatory failure and deepening coma. Convulsions may occur from respiratory failure. Blood concentrations of codeine ranged from 1.4 to 5.6 mg/l in eight adults whose deaths were attributed primarily to codeine overdosage.

Primary attention should be given to the re-establishment of adequate respiratory exchange through the provision of a patent airway and the institution of controlled ventilation. Oxygen, intravenous fluids, vasopressors and other supportive measures should be employed as indicated. Opioid antagonists may be employed. Gastric lavage should be considered. Patients should remain under observation, as per hospital guidelines and on a case per case basis.

Paracetamol

Because of its ready availability, paracetamol is often taken in overdosage. Toxicity is likely if more than 150 mg/kg of paracetamol is ingested. The major complication is acute hepatic necrosis, although without treatment fewer than 10% of unselected patients are at risk of severe liver damage (plasma aminotransferase > 1000 mg/l). About 1% develop fulminant hepatic failure which is usually fatal. Renal failure from acute tubular necrosis is a further uncommon complication which may develop in the absence of hepatic failure. There are no specific early manifestations of severe paracetamol poisoning. Consciousness is not impaired except in the occasional unusually severely poisoned patient with metabolic acidosis, and maximum abnormality of liver function tests is delayed for at least 3 days.

Emergency estimation of the plasma paracetamol concentration is therefore necessary to determine the severity of intoxication and the need for specific therapy with N-acetylcysteine (NAC).

Patients who have ingested more than 150 mg/kg should have gastric lavage performed if they present within an hour of ingestion. Activated charcoal may also be given. A plasma paracetamol level will indicate the likelihood of a patient developing high ALT/AST activities (i.e> 1,000 i.u. /L) and must be measured at least 4 hours after ingestion. Plasma levels measured less than 4 hours post-ingestion cannot be interpreted. Patients with a plasma level above the treatment line require N-acetylcysteine (NAC). A paracetamol normogram should be employed to determine treatment levels.

Patients who present to an Accident and Emergency Department more than 8 hours after ingesting a paracetamol overdose are at greater risk of developing hepatic damage. In cases of severe poisoning, hepatic failure may progress to encephalopathy, coma and death.

Blood should be taken for a plasma level, but the NAC infusion should be started as soon as possible if more than 150 mg/kg was taken. The NAC infusion should not be delayed while awaiting the result of the plasma paracetamol level. Administration of the antidote should be stopped if the plasma level is subsequently found to be below the treatment line. General supportive measures must be available.

At the end of the NAC infusion, blood should be taken to check the INR and creatinine concentration. If the investigations are abnormal, a further infusion of NAC (at 16 hour dose), to be continued until recovery or death, should be considered.

In the range of concentrations associated with overdosage, paracetamol may give a false positive result for plasma salicylate in tests based on the direct colour reaction with ferric ions. In the same circumstances it may induce spuriously high results for blood dextrose estimated with the YSI and Yellow Springs Model 23AM dextrose analyzers. Conversely, it may cause falsely low results for dextrose when the dextrose peroxidase/dextrose-6-phosphate dehydrogenase method is used

Liver damage following overdosage is relatively uncommon in young children.

5. Pharmacological Properties

5.1 Pharmacodynamic Properties

Pharmacotherapeutic group: Anilides, Paracetamol combinations

ATC Code: NO2B E51

Paracetamol is an analgesic which acts peripherally, probably by blocking impulse generation at the bradykinin sensitive chemo-receptors which evoke pain. Paracetamol is a weak, reversible, isoform-nonspecific cyclooxygenase inhibitor at dosages of 1 g daily. The inhibitory effect of paracetamol on cyclooxygenase-1 is limited, and the drug does not inhibit platelet function. Animal studies have indicated that paracetamol strongly inhibits prostaglandin synthetase in the brain (which may account for its antipyretic and analgesic effects) but that it has little effect on peripheral tissue prostaglandins (which are involved in inflammatory reactions).

Codeine is a centrally acting analgesic. Codeine exerts its effect through µ opioid receptors, although codeine has an exceptionally low affinity or these receptors, and its analgesic effect is due to its conversion to morphine. However, its antitussive actions may involve distinct receptors that bind codeine itself.

The conversion of codeine to morphine is effected by the CYP2D6. Well-characterised genetic polymorphism in CYP2D6 lead to the inability to covert codeine to morphine, thus making codeine ineffective as an analgesic for about 10% of the Caucasian population.

The fixed combination of paracetamol and codeine has been shown to be effective in acute nociceptive pain. However, data in chronic pain, cancer pain and neuropathic pain are lacking.

5.2 Pharmacokinetic Properties

Paracetamol is rapidly and completely absorbed after oral administration, with peak plasma concentrations occurring between 15 min and 2 h after ingestion. Paracetamol is distributed throughout most body tissues, with an apparent volume of distribution of approximately 1 L/kg of body weight. Concentrations in whole blood are up to 20% higher and in breast milk about 20% lower. Paracetamol crosses the placenta. Paracetamol is extensively metabolised in the liver and the total body clearance is about 5 ml/min/1/kg. Some 2-5% of a therapeutic dose of paracetamol is excreted unchanged in the urine.

Codeine is absorbed rapidly following oral administration; peak plasma concentrations occur in about 1 h and the plasma half-life is about 3.5 h. The volume of distribution is approximately 3.6 l/kg. The total body clearance of codeine is approximately 0.85 l/min. Codeine crosses the placenta and is present in the milk of lactating mothers.

Codeine is metabolised in the liver by O-demethylation to form morphine (codeine is in fact a pro-drug to morphine), and other metabolites. After an oral dose, about 86% is excreted in the urine in 24 h as free drug and metabolites, mostly in the form of metabolites. Some of a dose of codeine is excreted in the bile and trace amounts are found in the faeces. Unchanged drug accounts for 6-8% of the dose in urine in 24 h.

The bioavailabilities of paracetamol and codeine, when given as the combination, are similar to those when they are given separately.

5.3 Preclinical Safety Data

There are no findings of relevance to the prescriber other than those already mentioned elsewhere in the SPC.

6. Pharmaceutical Particulars

6.1 List Of Excipients

Sodium Hydrogen carbonate

Sodium carbonate anhydrous

Citric acid anhydrous

Sorbitol Neosorb P60 W

Povidone K30

Sodium Saccharin

Macrogol 6000

Grapefruit flavour

6.2 Incompatibilities

Not applicable

6.3 Shelf Life

2 years

6.4 Special Precautions For Storage

Do not store above 25°C

6.5 Nature And Contents Of Container

Strips of Aluminium / polyethylene foils

Each strip contains 4 tablets individually packed in cardboard containers.of 100 tablets.

6.6 Special Precautions For Disposal And Other Handling

The tablets should be placed in a glass of water and allowed to be dissolved completely. The resulting solution should be drunk immediately.

No special requirements for disposal

7. Marketing Authorisation Holder

Goldshield Pharmaceuticals Ltd

NLA Tower 12-16 Addiscombe Road

Croydon CR0 0XT

United Kingdom

8. Marketing Authorisation Number(S)

PL 12762/0405

9. Date Of First Authorisation/Renewal Of The Authorisation

16/08/2010

10. Date Of Revision Of The Text

07/02/2011

Varicella Pneumonitis Medications

There are currently no drugs listed for "Varicella Pneumonitis".

Learn more about Varicella Pneumonitis

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• Varicella

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• Chickenpox

Drug List:

Urokinase 10,000 I.U.

1. Name Of The Medicinal Product

Urokinase medac 10,000 I.U.

Powder for solution for injection or infusion

2. Qualitative And Quantitative Composition

Each vial contains 10,000 I.U. of human urokinase extracted from human urine.

For a full list of excipients, see section 6.1.

3. Pharmaceutical Form

Powder for solution for injection or infusion

4. Clinical Particulars

4.1 Therapeutic Indications

Intravascular lysis of blood clots in the following conditions:

• extensive acute proximal deep vein thrombosis

• acute massive pulmonary embolism

• acute occlusive peripheral arterial disease with limb threatening ischemia

• thrombosed arteriovenous haemodialysis shunts

• thrombosed central venous catheters

4.2 Posology And Method Of Administration

Urokinase medac should only be used by physicians experienced in the management of thrombotic diseases in hospitals where adequate diagnostic and monitoring techniques are available.

Depending on the indication, the route of administration of Urokinase medac is by systemic intravenous infusion, by local intra-arterial catheter-directed infusion during arteriography, or by local instillation.

It must not be given by subcutaneous or intramuscular injection.

For instructions regarding reconstitution and further dilution, see section 6.6.

Adults

The dosage may be adjusted individually depending on the clinical condition. The following dose regimens should be used as a guideline.

Deep vein thrombosis

Urokinase medac should be administered by intravenous infusion into a peripheral vein using an initial dose of 4,400 I.U./kg bodyweight infused over 10 – 20 min, followed by a maintenance dose of 100,000 I.U. per hour for 2 – 3 days.

Pulmonary embolism

Urokinase medac should be administered by intravenous infusion into a peripheral vein using an initial dose of 4,400 I.U./kg bodyweight infused over 10 – 20 min, followed by a maintenance dose of 4,400 I.U./kg bodyweight per hour for 12 hours.

Occlusive peripheral arterial disease

Urokinase medac should be administered by local intra-arterial catheter-directed graded infusion using an initial dose of 4,000 I.U./min (i.e. 240,000 I.U. per hour) for 2 – 4 hours or until restoration of antegrade flow, followed by a dose of 1,000 – 2,000 I.U./min until complete lysis or a maximum of 48 hours.

Thrombosed arteriovenous haemodialysis shunts

Urokinase medac should be administered by local forced periodic infusion (pulse spray) into both branches of the shunt at a concentration of 5,000 to 25,000 I.U./ml up to a total dose of 250,000 I.U. If necessary, the application can be repeated every 30 – 45 minutes up to a maximum of 2 hours.

Thrombosed central venous catheters

Urokinase medac should be dissolved in physiological saline at a concentration of 5,000 I.U./ml. A volume sufficient to completely fill the lumen of the occluded catheter should be instilled and either locked for a duration of 20 to 60 minutes or pushed with aliquots of saline before the lysate is aspirated. The procedure may be repeated if necessary.

Special populations

• Elderly patients: Available data are limited in patients over 65 years and it is not known whether they respond differently from younger subjects. Urokinase medac should be used with caution in elderly patients (see section 4.4).

• Patients with renal or hepatic impairment: A dose reduction may be required in patients with impaired renal and/or hepatic function. In these cases, the fibrinogen level should not fall below 100 mg/dl.

Paediatric patients

There is very limited experience with urokinase in children with thromboembolic occlusive vascular disease and urokinase should not be used in this indication.

Urokinase medac may be used in children of all ages for the treatment of thrombosed central venous catheters using the same lock procedure as in adults.

Therapeutic monitoring

Before starting thrombolytic therapy, haemostasis tests should be performed including haematocrit, platelet count, thrombin time (TT) and activated partial thromboplastin time (aPTT).

If heparin has been given, it should be discontinued and the aPTT should be less than twice the normal control value before urokinase therapy is initiated.

For systemic administration, a 3 to 5 fold prolongation of the TT measured 4 hours after initiation of therapy is generally considered sufficient. However, results of coagulation tests and fibrinolytic activity do not reliably predict either efficacy or risk of bleeding.

Follow-up treatment

In order to prevent recurrent thrombosis subsequent administration of anticoagulants should be instituted provided the aPTT is less than twice the normal control value.

4.3 Contraindications

• Hypersensitivity to the active substance or to any of the excipients

• Active clinically relevant bleeding

• Aneurysm and arteriovenous malformation

• Intracranial neoplasm or other neoplasm with risk of haemorrhage

• Decreased blood coagulation (haemorrhagic diathesis, concomitant therapy with anticoagulants, spontaneous fibrinolysis) and severe thrombocytopenia

• Severe uncontrolled arterial hypertension (systolic > 200 mmHg, diastolic > 100 mmHg; grade III or IV hypertensive retinopathy)

• Acute pancreatitis, pericarditis, bacterial endocarditis, sepsis

• Recent cerebrovascular accident (e.g. within 2 months)

• Recent trauma including cardiopulmonary resuscitation, thoracic surgery or neurosurgery (e.g. within 2 months)

• Recent major surgery until primary wound healing, recent organ biopsy, lumbar puncture, translumbal aortography (e.g. within 10 days)

4.4 Special Warnings And Precautions For Use

In the following conditions, the risk of bleeding may be increased and should be weighed against the anticipated benefits:

• Recent severe gastrointestinal bleeding

• Recent surgery other than thoracic or neurosurgery, recent obstetrical delivery, puncture of non-compressible vessels

• Moderate coagulation defects including those due to severe hepatic or renal diseases

• Cavernous pulmonary diseases

• Genitourinary tract diseases with existing or potential sources of bleeding (e.g. implanted bladder catheter)

• High likelihood of a left heart thrombus (e.g. mitral stenosis with atrial fibrillation) with possible risk of cerebral embolism

• Known septic thrombotic disease

• Severe cerebrovascular disease

• Elderly patients (especially those over 75 years)

Concomitant administration of urokinase with other thrombolytic agents, anticoagulants, or agents inhibiting platelet function may further increase the risk of serious bleeding (see section 4.5).

When bleeding occurs in patients receiving urokinase, it may be difficult to control. Although urokinase is intended to produce sufficient amounts of plasmin to lyse intravascular deposits of fibrin, other fibrin deposits including those which provide haemostasis (at sites of needle puncture, catheter insertion, cut, etc.) are also subject to lysis, and bleeding from such sites may result. Oozing of blood from sites of percutaneous trauma occurs frequently.

The possibility of bruising or haematoma formation, especially after intramuscular injections, is high during urokinase therapy. Intramuscular injections and unnecessary handling of the patient should be avoided. Venipunctures and invasive venous procedures should be performed as infrequently as possible and with care to minimize bleeding. If bleeding from an invasive site is not serious, urokinase therapy may be continued while closely observing the patient; local measures such as application of pressure should be initiated immediately.

Arterial invasive procedures must be avoided before and during urokinase treatment to minimise bleeding. If an arterial puncture is absolutely essential, it should be performed by a physician experienced in the procedure, using a radial or brachial rather than a femoral artery. Direct pressure should be applied at the puncture site for at least 30 minutes, a pressure dressing applied, and the site checked frequently for evidence of bleeding.

If severe bleeding occurs following systemic treatment with urokinase, infusion should be stopped immediately and measures to manage the bleeding implemented. Plasma volume expanders other than dextrans may be used to replace blood volume deficits; if blood loss has been extensive, administration of packed red blood cells is preferred to whole blood. If very rapid reversal of the fibrinolytic state is required, administration of an antifibrinolytic agent such as epsilon-aminocaproic acid may be considered (see section 4.9).

Urokinase medac is a highly purified enzyme produced from human urine. It also contains human serum albumin. Products manufactured from human source materials have the potential to transmit infectious agents. Procedures to control such risks strongly reduce but cannot completely eliminate the risk of transmitting infectious agents.

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

Anticoagulants

Oral anticoagulants or heparin may increase the risk of haemorrhage and should not be used concomitantly with urokinase.

Active substances affecting platelet function

Due to increased risk of haemorrhage, concomitant use of urokinase and active substances that affect platelet function (e.g., acetylsalicylic acid, other non-steroidal anti-inflammatory agents, dipyridamole, dextrans) should be avoided.

Contrast agents

Contrast agents may delay fibrinolysis.

4.6 Pregnancy And Lactation

There are no adequate data from the use of urokinase in pregnant women. Animal studies are insufficient with respect to effects on pregnancy, embryonal/fetal development, parturition or postnatal development. The potential risk for humans is unknown. However, low-molecular urokinase fragments and active plasmin cross the placenta.

Urokinase should not be used during pregnancy or in the immediate post-partum period unless clearly necessary.

It is unknown whether urokinase is excreted into human breast milk. Breast-feeding should be avoided during treatment with urokinase.

4.7 Effects On Ability To Drive And Use Machines

Not relevant.

4.8 Undesirable Effects

Haemorrhage

The most frequent and severe adverse effect of urokinase therapy is haemorrhage. The haemostatic status of the patient may be more profoundly altered with urokinase therapy than with heparin or coumarin-derivative anticoagulant therapy.

Severe spontaneous bleeding, including fatalities resulting from cerebral haemorrhage, has occurred during urokinase therapy. Less severe spontaneous bleeding has occurred approximately twice as frequently as that occurring during heparin therapy. Patients with pre-existing haemostatic defects have the greatest risk of spontaneous bleeding.

Moderate decreases in haematocrit not accompanied by clinically detectable bleeding have been reported in approximately 20 % of patients receiving urokinase.

Hypersensitivity reactions

In contrast to streptokinase, urokinase is reportedly non-antigenic. However, mild allergic reactions including bronchospasm and rash have been reported rarely. In addition, very rare cases of fatal anaphylaxis have been reported.

Infusion reactions

Fever and chills, including shaking chills (rigors), have been reported occasionally in patients receiving urokinase. Symptomatic treatment is usually sufficient to alleviate discomfort caused by urokinase-induced fever; however, acetylsalicylic acid should not be used.

Other infusion reactions reported with urokinase therapy include dyspnoea, cyanosis, hypoxemia, acidosis, back pain, and nausea and/or vomiting; these reactions generally occurred within one hour of beginning urokinase infusion.

The following frequency convention was used as a basis for the evaluation of undesirable effects:

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

Immune system disorders

Rare	Hypersensitivity reactions including dyspnoea, hypotension, flushing, urticaria, rash
Very rare	Anaphylactic reactions

Vascular disorders

Very common	Haemorrhage from puncture sites, wounds
Haematoma
Epistaxis, gingival bleeding
Haematuria (microscopic)
Common	Intracranial haemorrhage
Gastrointestinal haemorrhage, retroperitoneal haemorrhage
Urogenital haemorrhage
Muscle haemorrhage
Embolism, including cholesterol embolism
Uncommon	Intrahepatic haemorrhage

General disorders and administration site conditions

Common

Fever, chills

Investigations

Very common

Decrease in haematocrit without clinically detectable haemorrhage Transient increase in transaminases

4.9 Overdose

Haemorrhage that occurs during treatment with urokinase may be controlled with local pressure and treatment continued. If severe bleeding occurs, treatment with urokinase must be stopped and inhibitors such as aprotinin, epsilon-aminocaproic acid, p-aminoethylbenzoic acid or tranexamic acid can be given. In serious cases, human fibrinogen, factor XII, packed red cells or whole blood should be given as appropriate. For correction of volume deficiency, dextrans should be avoided.

5. Pharmacological Properties

5.1 Pharmacodynamic Properties

ATC code: B01A D04, antithrombotic agent.

Urokinase medac is a highly purified form of naturally occurring human urokinase extracted from urine. Urokinase exists in two distinct molecular entities, a high molecular weight (approximately 54,000 daltons) and a low molecular weight (approximately 33,000 daltons). Urokinase medac contains more than 85 % of the HMW form.

Urokinase is a thrombolytic agent which converts plasminogen into plasmin (fibrinolysin) a proteolytic enzyme that degrades fibrin as well as fibrinogen and other plasma proteins. The activity of urokinase leads to a dose-dependent decrease in plasminogen and fibrinogen levels and to increased presence of fibrin and fibrogen degradation products, which have an anticoagulant effect and potentiate the effect of heparin. These effects persist for 12 – 24 hours after the end of urokinase infusion.

5.2 Pharmacokinetic Properties

Urokinase is eliminated rapidly from the circulation by the liver with a half-life of 10 to 20 minutes. The inactive degradation products are excreted via the bile and primarily via the kidneys.

Elimination is delayed in patients with liver disease and impaired kidney function.

5.3 Preclinical Safety Data

There is no preclinical safety data of additional value to the prescribing physician.

6. Pharmaceutical Particulars

6.1 List Of Excipients

Disodium phosphate dodecahydrate, sodium dihydrogen phosphate dihydrate, human albumin.

6.2 Incompatibilities

No information is available regarding loss of activity in PVC containers or plastic bags/syringes.

6.3 Shelf Life

26 months

Use reconstituted material immediately.

After reconstitution and dilution, chemical and physical stability has been demonstrated for 72 hours at room temperature. From a microbiological point of view, the product should be used immediately after reconstitution and dilution. If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user and would normally not be longer than 24 hours at 2 °C to 8 °C.

6.4 Special Precautions For Storage

Do not store above 25 ºC.

Keep the vial in the outer container to protect from light.

6.5 Nature And Contents Of Container

All presentations are contained in borosilicate clear type 1 glass vials closed with chlorobutyl rubber stoppers and sealed with an aluminium flip-off cap.

6.6 Special Precautions For Disposal And Other Handling

The powder for solution for infusion should be dissolved in water for injection and further diluted with 0.9 % sodium chloride solution or glucose 5 % or glucose 10 % solution.

The powder is to be reconstituted as follows:

For a 10,000 I.U. vial use 2 ml of water for injection.

After reconstitution the solution must be clear and colourless.

7. Marketing Authorisation Holder

medac

Gesellschaft für klinische

Spezialpräparate mbH

Fehlandtstr. 3

20354 Hamburg

Germay

Phone: +49 (0)4103 8006-0

Fax: +49 (0)4103 8006-100

8. Marketing Authorisation Number(S)

PL 11587/0065

9. Date Of First Authorisation/Renewal Of The Authorisation

17/03/2010

10. Date Of Revision Of The Text

22/09/2010

Urogesic Blue

Dosage Form: tablet
UROGESIC-BLUE™

Rx Only

Description

Each tablet contains:

	Methenamine, USP	81.6 mg
	Monobasic Sodium Phosphate, USP	40.8 mg
	Methylene Blue, USP	10.8 mg
	Hyoscyamine Sulfate, USP	0.12 mg

Inactive Ingredients include: microcrystalline cellulose, NF, mannitol, USP, croscarmellose sodium, NF, magnesium stearate, NF and lake blend blue.

HYOSCYAMINE SULFATE is an alkaloid of belladonna. Exists as a white crystalline powder. Affected by light. It is very soluble in water; freely soluble in alcohol; practically insoluble in ether.

METHENAMINE exists as colorless, lustrous crystals or white crystalline powder. Its solutions are alkaline to litmus. Freely soluble in water; soluble in alcohol and in chloroform.

METHYLENE BLUE exists as dark green crystals. It is soluble in water and in chloroform; sparingly soluble in alcohol.

MONOBASIC SODIUM PHOSPHATE exists as a white crystalline powder. Its solutions are acidic to litmus. It is freely soluble in water and practically insoluble in alcohol.

Urogesic Blue - Clinical Pharmacology

HYOSCYAMINE is a parasympatholytic which relaxes smooth muscles and thus produces an antispasmodic effect. It is well absorbed from the gastrointestinal tract and is rapidly distributed throughout body tissues. Most is excreted in the urine within 12 hours, 13% to 50% being unchanged. Its biotransformation is hepatic. Its protein binding is moderate.

METHENAMINE degrades in an acidic urine environment releasing formaldehyde which provides bactericidal or bacteriostatic action. It is well absorbed from the gastrointestinal tract. 70% to 90% reaches the urine unchanged at which point it is hydrolyzed if the urine is acidic. Within 24 hours it is almost completely (90%) excreted; of this amount at pH 5, approximately 20% is formaldehyde. Protein binding: some formaldehyde is bound to substances in the urine and surrounding tissues. Methenamine is freely distributed to body tissue and fluids but is not clinically significant as it does not hydrolyze at pH greater than 6.8.

METHYLENE BLUE possesses weak antiseptic properties. It is well absorbed in the gastrointestinal tract and is rapidly reduced to leukomethylene blue which is stabilized in some combination form in the urine. 75% is excreted unchanged.

MONOBASIC SODIUM PHOSPHATE helps to maintain an acid pH in the urine necessary for the degradation of methenamine.

Indications and Usage for Urogesic Blue

UROGESIC-BLUE™ is indicated for the treatment of symptoms of irritative voiding. Indicated for the relief of local symptoms, such as hypermotility which accompany lower urinary tract infections and as antispasmodic. Indicated for the relief of urinary tract symptoms caused by diagnostic procedures.

Contraindications

UROGESIC-BLUE™ is contraindicated in patients with a hypersensitivity to any of the ingredients. Risk-benefit should be considered when the following medical problems exist: Cardiac disease (especially cardiac arrythmias, congestive heart failure, coronary heart disease, mitral stenosis); gastrointestinal tract obstructive disease; glaucoma; myasthenia gravis; acute urinary retention may be precipitated in obstructive uropathy (such as bladder neck obstruction due to prostatic hypertrophy).

Warnings

Do not exceed recommended dosage. If rapid pulse, dizziness, or blurring of vision occurs discontinue use immediately.

Precautions

Cross sensitivity and/or related problems

patients intolerant of belladonna alkaloids may be intolerant of this medication also.

Pregnancy/Reproduction

Pregnancy Category C

hyoscyamine and methenamine cross the placenta. Studies have not been done in animals or humans. It is not known whether UROGESIC-BLUE™ tablets cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. UROGESIC-BLUE™ tablets should be given to a pregnant woman only if clearly needed.

Breast-feeding

problems in humans have not been documented; however, methenamine and traces of hyoscyamine are excreted in breast milk.

Prolonged use

there have been no studies to establish the safety of prolonged use in humans. No known long-term animal studies have been performed to evaluate carcinogenic potential.

Pediatric

infants and young children are especially susceptible to the toxic effect of the belladonna alkaloids.

Geriatric

use with caution in elderly patients as they may respond to usual doses of hyoscyamine with excitement, agitation, drowsiness, or confusion.

Drug Interactions

because of this product's effect on gastrointestinal motility and gastric emptying, it may decrease the absorption of other oral medications during concurrent use such as: urinary alkalizers; thiazide diuretics (may cause the urine to become alkaline reducing the effectiveness of methenamine by inhibiting its conversion to formaldehyde); antimuscarinics (concurrent use may intensify antimuscarinic effects of hyoscyamine because of secondary antimuscarinic activities of these medications); antacids/antidiarrheals (may reduce absorption of hyoscyamine, concurrent use with antacids may cause urine to become alkaline reducing effectiveness of methenamine by inhibiting its conversion to formaldehyde) doses of these medications should be spaced 1 hour apart from doses of hyoscyamine; antimyasthenics (concurrent use with hyoscyamine may further reduce intestinal motility); ketoconazole (patients should be advised to take this combination at least 2 hours after ketoconazole); monoamine oxidase (MAO) Inhibitors (concurrent use may intensify antimuscarinic side effects, opoid (narcotic) analgesics may result in increased risk of severe constipation); sulfonamides (these drugs may precipitate with formaldehyde in the urine, increasing the danger of crystalluria).

Patients should be advised that the urine may become blue to blue green and the feces may be discolored as a result of the excretion of methylene blue.

Adverse Reactions

Cardiovascular – rapid pulse, flushing

Central Nervous System – blurred vision, dizziness

Respiratory – shortness of breath or troubled breathing

Genitourinary – difficulty micturition, acute urinary retention

Gastrointestinal – dry mouth, nausea/vomiting

Drug Abuse and Dependence

A dependence on the use of UROGESIC-BLUE™ has not been reported and due to the nature of its ingredients, abuse of UROGESIC-BLUE™ is not expected.

Overdosage

Emesis or gastric lavage. Slow intravenous administration of physostigmine in doses of 1 mg to 4 mg (0.5 mg to 1 mg in children), repeated as needed in one to two hours to reverse severe antimuscarinic symptoms. Administration of small doses of diazepam to control excitement and seizures. Artificial respiration with oxygen if needed for respiratory depression. Adequate hydration. Symptomatic treatment as necessary.

Urogesic Blue Dosage and Administration

Adults

One tablet orally 4 times per day followed by liberal fluid intake.

Older Children

Dosage must be individualized by physician. Not recommended for use in children up to 6 years of age.

How is Urogesic Blue Supplied

UROGESIC-BLUE™ are light blue to blue, oval, biconvex tablets debossed with "ED UB" with scoreline on one side and plain on the other side. Supplied in bottles of 100 tablets (NDC 0485-0051-01).

CAUTION

RX ONLY

STORAGE

Store at 25° C (77° F); excursions permitted to 15° C to 30° C (59° F to 86° F) [See USP Controlled Room Temperature]. Keep container tightly closed.

Manufactured for:

Edwards Pharmaceutical, Inc.

111 W. Mulberry St. Ripley, Mississippi 38663

Manufactured by:

Belcher Pharmaceuticals, Inc.

Largo, FL 33777

January 2010                    R - 0110

PRINCIPAL DISPLAY PANEL - 100 count Tablet Bottle Label

NDC 0485-0051-01

UROGESIC-BLUE ™

URINARY ANTISEPTIC

ANTISPASMODIC

DESCRIPTION: Each tablet contains:

Methenamine, USP	81.6 mg
Monobasic Sodium Phosphate, USP	40.8 mg
Methylene Blue, USP	10.8 mg
Hyoscyamine Sulfate, USP	0.12 mg

CONTENTS: 100 TABLETS

RX ONLY

Manufactured for

EDWARDS

PHARMACEUTICAL, INC.

Ripley, MS 38663

Urogesic Blue  methenamine, sodium phosphate, monobasic, methylene blue, and hyoscyamine sulfate  tablet

Product Information Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 0485-0051 Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength METHENAMINE (METHENAMINE) METHENAMINE 81.6 mg SODIUM PHOSPHATE, MONOBASIC (SODIUM CATION) SODIUM PHOSPHATE, MONOBASIC 40.8 mg METHYLENE BLUE (METHYLENE BLUE) METHYLENE BLUE 10.8 mg HYOSCYAMINE SULFATE (HYOSCYAMINE) HYOSCYAMINE SULFATE 0.12 mg

Inactive Ingredients Ingredient Name Strength CELLULOSE, MICROCRYSTALLINE   MANNITOL   CROSCARMELLOSE SODIUM   MAGNESIUM STEARATE

Product Characteristics Color BLUE Score 2 pieces Shape OVAL (biconvex) Size 13mm Flavor Imprint Code ED;UB Contains

Packaging # NDC Package Description Multilevel Packaging 1 0485-0051-01 100 TABLET In 1 BOTTLE, PLASTIC None

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Unapproved drug other		04/30/2010

Labeler - EDWARDS PHARMACEUTICAL, INC. (195118880)

Establishment
Name	Address	ID/FEI	Operations
BELCHER PHARMACEUTIALS, INC.		175968069	MANUFACTURE, ANALYSIS, PACK, LABEL

Revised: 04/2010EDWARDS PHARMACEUTICAL, INC.

More Urogesic Blue resources

• Urogesic Blue Use in Pregnancy & Breastfeeding
• Urogesic Blue Drug Interactions
• Urogesic Blue Support Group
• 16 Reviews for Urogesic Blue - Add your own review/rating

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