Beechams Veno’s Expectorant

1. Name Of The Medicinal Product

Beechams Veno's Expectorant

Veno's Expectorant

2. Qualitative And Quantitative Composition

Guaifenesin 100 mg, Glucose, liquid 3.0 g, Treacle 1.35 g

3. Pharmaceutical Form

Oral solution

4. Clinical Particulars

4.1 Therapeutic Indications

An expectorant for the symptomatic relief of coughs (including bronchial cough) and chesty cataarh, particularly associated with colds and flu.

The product also has a soothing, protective, demulcent action on a sore, irritated, tickling and inflamed throat.

4.2 Posology And Method Of Administration

Adults and children over the age of 12: Take one 10ml dose (two 5ml spoonfuls) and repeat every 2 to 3 hours.

Route of Administration

Oral

4.3 Contraindications

Known hypersensitivity to guaifenesin, treacle, glucose or to any of the excipients.

4.4 Special Warnings And Precautions For Use

Patients suffering from chronic cough or asthma should consult a physician before taking this product.

Patients should stop using the product and consult a health care professional if cough lasts for more than 5 days or comes back, or is accompanied by a fever, rash or persistent headache.

Do not take with a cough suppressant.

Special Label Warnings

Keep out of the reach and sight of children.

If symptoms persist, consult your doctor.

Do not exceed the stated dose.

Do not use with other cough and cold medicines.

Contains 6.68 g total sugars per 10 ml dose. This should be taken into account in patients with diabetes mellitus.

Patients with rare glucose-galactose malabsorption should not take this medicine.

Contains 9.6 mg sodium per 10 ml dose. This should be taken into consideration in patients on a controlled sodium diet.

Contains sodium benzoate and sodium metabisulphite, which may rarely cause severe allergic reactions and bronchospasm.

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

None.

4.6 Pregnancy And Lactation

Use in pregnancy and lactation is not contraindicated. However, as with all medicines, caution should be exercised during pregnancy and lactation.

4.7 Effects On Ability To Drive And Use Machines

None.

4.8 Undesirable Effects

Immune system disorders:

Unknown: allergic reactions, angioedema, anaphylactic reactions

Respiratory, thoracic and mediastinal disorders:

Unknown: Dyspnoea (in association with other symptoms of hypersensitivity)

Skin and subcutaneous disorders:

Unknown: Rash, urticaria

Gatrsointestinal disorders:

Unknown: nausea, vomiting, abdominal discomfort

4.9 Overdose

Very large doses of guaifenesin cause nausea and vomiting. Vomiting would be treated by fluid replacement and monitoring of electrolytes if indicated.

5. Pharmacological Properties

5.1 Pharmacodynamic Properties

Guaifenesin is an expectorant.

Treacle and liquid glucose are demulcents.

5.2 Pharmacokinetic Properties

None Stated.

5.3 Preclinical Safety Data

There are no preclinical data of any relevance additional to that already included in other sections of the SmPC.

6. Pharmaceutical Particulars

6.1 List Of Excipients

Macrogol, Glacial acetic acid, Sodium benzoate (E211), Capsicum tincture, Sodium metabisulphite (E223), Aniseed oil, Xanthan gum, Levomenthol, Camphor, Sodium cyclamate, Acesulfame potassium, Liquorice aniseed flavour and Caramel colour (E150).

6.2 Incompatibilities

None.

6.3 Shelf Life

Unopened: Three years.

Opened: Six months.

6.4 Special Precautions For Storage

None.

6.5 Nature And Contents Of Container

Amber cylindrical glass bottle fitted with a child resistant and tamper evident plastic screw cap.

Pack size: 100 or 160 ml.

6.6 Special Precautions For Disposal And Other Handling

None.

7. Marketing Authorisation Holder

Beecham Group Plc

980 Great West Road

Brentford

Middlesex

TW8 9GS

United Kingdom

trading as: GlaxoSmithKline Consumer Healthcare, Brentford, TW8 9GS, U.K.

8. Marketing Authorisation Number(S)

PL 00079/0208

9. Date Of First Authorisation/Renewal Of The Authorisation

31 January 1983 / 10 December 1998

10. Date Of Revision Of The Text

September 2010

SSD AF

Generic Name: silver sulfadiazine topical (SIL ver SUL fa DYE a zeen TOP ik al)

Brand Names: Silvadene, SSD, SSD AF, Thermazene

What is SSD AF (silver sulfadiazine topical)?

Silver sulfadiazine is an antibiotic. It fights bacteria and fungus on the skin.

Silver sulfadiazine topical (for the skin) is used to treat or prevent infections on areas of burned skin.

Silver sulfadiazine topical may also be used for purposes other than those listed in this medication guide.

What is the most important information I should know about SSD AF (silver sulfadiazine topical)?

You should not use this medication if you are allergic to silver sulfadiazine or another sulfa medication.

Before using this medication, tell your doctor if you have liver disease, kidney disease, or an enzyme deficiency called glucose-6-phosphate dehydrogenase deficiency (G6PD).

The person applying this medication to burn wounds should wear sterile disposable gloves. Take care to keep the treatment area as clean as possible to prevent further infection.

Use this medication for the full prescribed length of time. Your symptoms may improve before the infection is completely cleared.

Avoid exposing treated skin areas to sunlight, sunlamps, or tanning beds. Silver sulfadiazine can make your skin more sensitive to sunlight, and a sunburn may result. Wear protective clothing when you are outdoors. Call your doctor at once if you have a serious side effect such as fever, chills, flu symptoms, easy bruising or bleeding, unusual weakness, pale or yellowed skin, dark colored urine, ulcers on treated skin areas, swelling or weight gain, urinating less than usual, or a severe blistering or peeling red skin rash.

What should I discuss with my healthcare provider before using SSD AF (silver sulfadiazine topical)?

You should not use this medication if you are allergic to silver sulfadiazine or another sulfa medication.

If you have any of these other conditions, you may need a dose adjustment or special tests to safely use this medication:

• liver disease;


• kidney disease; or


• 
  

  an enzyme deficiency called glucose-6-phosphate dehydrogenase deficiency (G6PD).

  
  

FDA pregnancy category B. Silver sulfadiazine is not expected to be harmful to an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant during treatment. It is not known whether silver sulfadiazine passes into breast milk or if it could harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby.

How should I use SSD AF (silver sulfadiazine topical)?

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

Wash your hands before and after applying silver sulfadiazine cream. The person applying this medication to burn wounds should wear sterile disposable gloves. Take care to keep the treatment area as clean as possible to prevent further infection.

Clean the area to be treated as directed by your doctor. Apply enough of the medication to cover the affected area evenly. Silver sulfadiazine cream should be applied in a layer about one 16th of an inch thick (1.5 millimeter).

Silver sulfadiazine cream is usually applied 1 or 2 times daily. Burn wounds must be kept covered with this medication at all times. Treated skin areas can be left uncovered, or you may use a gauze bandage if directed by your doctor.

If needed, apply more cream to replace any medication that has come off on bandages, clothing, or bed linens. Reapply the cream after bathing or water therapy.

To be sure this medication is not causing harmful effects, your blood may need to be tested on a regular basis. Your kidney function may also need to be tested. Do not miss any follow-up visits to your doctor.

Use this medication for the full prescribed length of time. Your symptoms may improve before the infection is completely cleared.

Store silver sulfadiazine topical at room temperature away from moisture and heat.

What happens if I miss a dose?

Apply the missed dose as soon as you remember. Your burn wounds should be kept covered with silver sulfadiazine cream at all times.

What happens if I overdose?

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

An overdose of silver sulfadiazine is not likely to cause life-threatening symptoms.

What should I avoid while using SSD AF (silver sulfadiazine topical)?

Avoid exposing treated skin areas to sunlight, sunlamps, or tanning beds. Silver sulfadiazine can make your skin more sensitive to sunlight, and a sunburn may result. Wear protective clothing when you are outdoors. Avoid getting this medication in your mouth or eyes. If it does get into any of these areas, rinse with water. Do not use silver sulfadiazine topical on sunburned, windburned, dry, chapped, irritated, or broken skin.

SSD AF (silver sulfadiazine topical) side effects

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

• 
  

  fever, chills, body aches, flu symptoms;

  
  


• 
  

  easy bruising or bleeding, unusual weakness;

  
  


• 
  

  pale or yellowed skin, dark colored urine;

  
  


• 
  

  ulcers on treated skin areas;

  
  


• 
  

  blood in your urine;

  
  


• 
  

  urinating less than usual or not at all;

  
  


• 
  

  drowsiness, confusion, mood changes, nausea and vomiting;

  
  


• 
  

  swelling, weight gain; or

  
  


• 
  

  fever, sore throat, and headache with a severe blistering, peeling, and red skin rash.

  
  

Less serious side effects may include:

• 
  

  brown or gray discoloration of treated skin;

  
  


• 
  

  mild itching or burning; or

  
  


• 
  

  upset stomach.

  
  

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What other drugs will affect SSD AF (silver sulfadiazine topical)?

Tell your doctor about all other medications you use, especially cimetidine (Tagamet).

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

More SSD AF resources

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

• SSD AF Topical Advanced Consumer (Micromedex) - Includes Dosage Information


• Silvadene MedFacts Consumer Leaflet (Wolters Kluwer)


• Silvadene Prescribing Information (FDA)


• Thermazene Prescribing Information (FDA)

Compare SSD AF with other medications

• Burns, External

Where can I get more information?

• Your pharmacist can provide more information about silver sulfadiazine topical.

See also: SSD AF side effects (in more detail)

Combivent

Generic Name: ipratropium and albuterol (Inhalation route)

ip-ra-TROE-pee-um BROE-mide, al-BUE-ter-ol SUL-fate

Commonly used brand name(s)

In the U.S.

• Combivent


• Combivent Respimat


• Duoneb

In Canada

• Ratio-Ipra Sal Udv

Available Dosage Forms:

• Aerosol Powder


• Solution


• Spray


• Aerosol Liquid

Therapeutic Class: Bronchodilator

Pharmacologic Class: Ipratropium

Uses For Combivent

Ipratropium and albuterol combination is used to help control the symptoms of lung diseases, such as asthma, chronic bronchitis, and emphysema. It is also used to treat air flow blockage and prevent the worsening of chronic obstructive pulmonary disease (COPD) in patients who need another medicine.

Ipratropium and albuterol belong to the family of medicines known as bronchodilators. Bronchodilators are medicines that are breathed in through the mouth to open up the bronchial tubes (air passages) in the lungs.

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

Before Using Combivent

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 have not been performed on the relationship of age to the effects of ipratropium and albuterol combination in the pediatric population. Safety and efficacy have not been established.

Geriatric

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of Combivent® Respimat® spray in the elderly.

No information is available on the relationship of age to the effects of Combivent® 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. 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.

• Acebutolol


• Alprenolol


• Arotinolol


• Atenolol


• Atomoxetine


• Befunolol


• Betaxolol


• Bevantolol


• Bisoprolol


• Bopindolol


• Brofaromine


• Bucindolol


• Bupranolol


• Carteolol


• Carvedilol


• Celiprolol


• Clorgyline


• Dilevalol


• Esmolol


• Furazolidone


• Iproniazid


• Isocarboxazid


• Labetalol


• Landiolol


• Lazabemide


• Levobetaxolol


• Levobunolol


• Linezolid


• Mepindolol


• Metipranolol


• Metoprolol


• Moclobemide


• Nadolol


• Nebivolol


• Nialamide


• Nipradilol


• Oxprenolol


• Pargyline


• Penbutolol


• Phenelzine


• Pindolol


• Procarbazine


• Propranolol


• Rasagiline


• Selegiline


• Sotalol


• Talinolol


• Tertatolol


• Timolol


• Toloxatone


• Tranylcypromine

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.

• Betel Nut

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:

• Allergy to soya lecithin, soybean, or peanuts, history of—Combivent® brand should not be used in patients with this condition.

• Blood circulation problems or


• Heart or blood vessel disease or


• Heart rhythm problems (e.g., arrhythmia) or


• Hypertension (high blood pressure)—Use with caution. May increase risk for serious side effects.

• Diabetes or


• Difficult urination or


• Enlarged prostate or


• Hyperthyroidism (an overactive thyroid) or


• Hypokalemia (low potassium in the blood) or


• Narrow-angle glaucoma or


• Seizures or


• Urinary bladder blockage—Use with caution. May make these conditions worse.

Proper Use of ipratropium and albuterol

This section provides information on the proper use of a number of products that contain ipratropium and albuterol. It may not be specific to Combivent. Please read with care.

This medicine usually comes with patient directions or instructions. Read them carefully before using the medicine. If you do not understand the directions or you are not sure how to use the inhaler or nebulizer, ask your doctor to show you how to use it.

Use this medicine only as directed by your doctor. Do not use more of it and do not use it more often than your doctor ordered. Also, do not stop using this medicine without telling your doctor. To do so may cause your lung condition to become worse.

When you use the inhalation solution, make sure you use a jet nebulizer that is connected to an air compressor with a good air flow. Use a face mask or mouthpiece to inhale the medicine.

Keep the spray away from your eyes. This medicine may cause eye pain or discomfort, irritation, blurred vision, or start seeing halos or odd colors when you look at things. If it does come into contact with your eyes, check with your doctor right away.

To use the Combivent® inhaler:

• Insert the metal canister firmly and fully into the clear end of the Combivent® Inhalation Aerosol mouthpiece. This mouthpiece should not be used with other inhaled medicines.


• Remove the cap and look at the mouthpiece to make sure it is clean.


• Shake the inhaler for at least 10 seconds and test spray it in the air 3 times before using it for the first time or if the inhaler has not been used for 24 hours.


• To inhale this medicine, breathe out fully, trying to get as much air out of the lungs as possible. Put the mouthpiece just in front of your mouth with the canister upright.


• Open your mouth and breathe in slowly and deeply (like yawning), and at the same time firmly press down once on the top of the canister.


• Hold your breath for about 10 seconds, then breathe out slowly.


• If you are supposed to use more than one puff, wait 1 to 2 minutes before inhaling the second puff. Repeat these steps for the second puff, starting with shaking the inhaler.


• When you have finished all of your doses, rinse your mouth with water.


• Clean the inhaler mouthpiece every day with hot water. Dry it thoroughly before use.

To use the Combivent® Respimat® spray:

• Insert the cartridge into the Combivent® Respimat® inhaler.


• Before using the inhaler, prime it by spraying the medicine towards the ground (away from your face), until an aerosol cloud is visible. Repeat 3 more times. The inhaler is now ready for use.


• If the inhaler is not used for more than 3 days, prime the inhaler once to prepare it for use. If it not used for more than 21 days, prime the inhaler 3 times.


• To inhale this medicine, breathe out fully, trying to get as much air out of the lungs as possible.


• Open your mouth and breathe in slowly and deeply (like yawning), and at the same time firmly press down once the release button of the inhaler.


• Hold your breath for about 10 seconds, then breathe out slowly.


• After using the inhaler, clean the mouthpiece with a damp cloth or tissue at least once a week.


• This inhaler has a dose indicator window that shows how much medicine is left. When the pointer enters the red area of the scale, it is time that you need to refill your prescription.


• Throw away the inhaler 3 months from its first use or when the inhaler is locked (after 120 puffs).

Use only the brand of this medicine that your doctor prescribed. Different brands may not work the same way.

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 symptoms of chronic obstructive pulmonary disease (COPD):
  
  • For inhalation aerosol dosage form (used with an inhaler):
    
    • Adults—2 puffs four times a day and as needed. Do not use more than 12 puffs in any 24-hour period.
    
    
    • Children—Use and dose must be determined by your doctor.
    
    
  
  
  • For inhalation solution dosage form (used with a nebulizer):
    
    • Adults—Use one 3 milliliter (mL) vial in the nebulizer four times a day. You may use 2 additional treatments per day if needed.
    
    
    • Children—Use and dose must be determined by your doctor.
    
    
  
  
  • For inhalation spray dosage form (used with an inhaler):
    
    • Adults—One puff four times a day. You may take additional doses per day if needed. Do not use more than 6 puffs in any 24-hour period.
    
    
    • Children—Use and dose must be determined by your doctor.
    
    
  
  

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 canister at room temperature, away from heat and direct light. Do not freeze. Do not keep this medicine inside a car where it could be exposed to extreme heat or cold. Do not poke holes in the canister or throw it into a fire, even if the canister is empty.

Keep the medicine in the foil pouch until you are ready to use it. Store at room temperature, away from heat and direct light. Do not freeze.

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 Combivent

It is very important that your doctor check your progress closely while you are using this medicine to see if it is working properly and to help reduce any unwanted effects.

This medicine may cause paradoxical bronchospasm, which means your breathing or wheezing will get worse. Paradoxical bronchospasm may be life-threatening. Stop using this medicine and check with your doctor right away if you have coughing, difficulty breathing, shortness of breath, or wheezing after using this medicine.

Check with your doctor at once if difficulty with breathing continues after using a dose of this medicine or if your condition gets worse.

This medicine may cause serious types of allergic reactions, including anaphylaxis. Anaphylaxis can be life-threatening and requires immediate medical attention. Call your doctor right away if you have a rash; itching; hives; hoarseness; trouble with breathing; trouble with swallowing; or any swelling of your hands, face, or mouth while you are using this medicine.

Tell your doctor right away if you feel chest pain, notice any changes in your blood pressure (such as feeling lightheaded or changes in vision), or notice your heart beating faster or slower .

Take all of your COPD medicines as your doctor ordered. If you use any type of corticosteroid medicine to control your breathing, keep using it as ordered by your doctor. This includes corticosteroid medicines that are taken by mouth or inhaled (such as prednisone, Azmacort®, or Flovent®). If any of your COPD medicines do not seem to be working as well as usual, call your doctor right away. Do not change your doses or stop using your medicines without asking your doctor.

This medicine may cause dizziness, blurred vision, or trouble in seeing clearly. Make sure you know how you react to this medicine before you drive, use machines, or do other jobs that require you to be alert, well-coordinated, or able to see well.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines for appetite control, asthma, colds, cough, hay fever, or sinus problems, and herbal or vitamin supplements. .

Combivent 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:

More common

• Body aches or pain


• chills


• cough


• cough producing mucus


• difficulty with breathing


• ear congestion


• fever


• headache


• loss of voice


• runny nose


• shortness of breath


• sneezing


• sore throat


• stuffy nose


• tightness in the chest


• unusual tiredness or weakness


• wheezing

Less common

• Bladder pain


• bloody or cloudy urine


• blurred vision


• burning while urinating burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings


• chest pain


• congestion


• diarrhea


• difficult, burning, or painful urination


• dizziness


• fainting


• fast, slow, irregular, pounding, or racing heartbeat or pulse


• frequent urge to urinate


• general feeling of discomfort or illness


• hoarseness


• increased sputum


• joint pain


• loss of appetite


• lower back or side pain


• muscle aches and pains


• nausea


• nervousness


• noisy breathing


• pain


• pain or tenderness around the eyes and cheekbones


• pounding in the ears


• shakiness in the legs, arms, hands, or feet


• shivering


• sweating


• swelling


• tender, swollen glands in the neck


• trembling or shaking of the hands or feet


• trouble with sleeping


• trouble with swallowing


• voice changes


• vomiting

Rare

• Skin rash or hives


• swelling of the face, lips, eyelids, mouth, or throat

Incidence not known

• Chest discomfort


• decrease in the frequency of urination


• decrease in urine volume


• difficulty in passing urine (dribbling)


• difficulty with swallowing


• itching skin


• large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs


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


• puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue


• redness of the skin


• welts

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

Less common

• Acid or sour stomach


• bad, unusual, or unpleasant (after) taste


• belching


• change in taste


• diarrhea


• difficulty with moving


• dry mouth


• heartburn


• hoarseness


• indigestion


• muscle pain or stiffness


• sleeplessness


• stomach discomfort, upset, or pain


• trouble sleeping


• unable to sleep


• voice changes

Less common or rare

• Nervousness


• tremor

Incidence not known

• Bigger, dilated, or enlarged pupils (black part of the eye)


• blindness


• change in near or distance vision


• decreased vision


• difficulty in focusing eyes


• dry throat


• eye pain


• increased sensitivity of the eyes to light


• itching, redness, tearing, or other sign of eye irritation not present before use of this medicine or becoming worse during use


• lack or loss of strength


• noisy breathing


• redness of the white part of the eyes or inside of the eyelids


• swelling of the eye


• swelling or inflammation of the mouth


• tearing

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: Combivent side effects (in more detail)

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More Combivent resources

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

• Combivent Prescribing Information (FDA)


• Combivent Consumer Overview


• Combivent Aerosol MedFacts Consumer Leaflet (Wolters Kluwer)


• DuoNeb Prescribing Information (FDA)


• DuoNeb Consumer Overview


• DuoNeb Solution MedFacts Consumer Leaflet (Wolters Kluwer)

Compare Combivent with other medications

• COPD, Maintenance

Lamisil AT Cream

terbinafine hydrochloride

Dosage Form: cream
Drug Facts

Active ingredient

Terbinafine hydrochloride

Purpose

Antifungal

Uses

• cures most athlete’s foot (tinea pedis)


• cures most jock itch (tinea cruris) and ringworm (tinea corporis)


• relieves itching, burning, cracking and scaling which accompany these conditions

Warnings

For external use only

Do Not Use

• on nails or scalp


• in or near the mouth or eyes


• for vaginal yeast infections

When using this product

do not get into eyes. If eye contact occurs, rinse thoroughly with water.

Stop use and ask doctor

if too much irritation occurs or gets worse

Keep out of reach of children

If swallowed, get medical help or contact a poison control center right away.

Directions

• adults and children 12 years and over:

    • use the tip of the cap to break the seal and open the tube

    • wash the affected skin with soap and water and dry completely before applying

    • for athlete’s foot wear well-fitting, ventilated shoes. Change shoes and socks at least once daily

        • between the toes only: apply twice a day (morning and night) for 1 week or as directed by a doctor

1 week between the toes

        • on the bottom or sides of the foot: apply twice a day (morning and night) for 2 weeks or as directed by a doctor

2 weeks on the bottom or sides of the foot

    • for jock itch and ringworm: apply once a day (morning or night) for 1 week or as directed by a doctor

    • wash hands after each use

• children under 12 years: ask a doctor

Other information

• do not use if seal on tube is broken or is not visible


• store at controlled room temperature 20-25°C (68-77°F)

Inactive ingredients

benzyl alcohol, cetyl alcohol, cetyl palmitate, isopropyl myristate, polysorbate 60, purified water, sodium hydroxide, sorbitan monostearate, stearyl alcohol.

Questions

call 1-800-452-0051

Novartis Consumer Health, Inc.

Parsippany, NJ 07054-0622 ©2008

Principal display panel

Lamisil AT Cream

LAMISIL  AT terbinafine hydrochloride  cream

Product Information Product Type HUMAN OTC DRUG NDC Product Code (Source) 0067-3998 Route of Administration TOPICAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength TERBINAFINE HYDROCHLORIDE (TERBINAFINE) TERBINAFINE HYDROCHLORIDE 10 mg  in 1 g

Inactive Ingredients Ingredient Name Strength BENZYL ALCOHOL   CETYL ALCOHOL   CETYL PALMITATE   ISOPROPYL MYRISTATE   POLYSORBATE 60   WATER   SODIUM HYDROXIDE   SORBITAN MONOSTEARATE   STEARYL ALCOHOL

Product Characteristics Color      Score      Shape Size Flavor Imprint Code Contains

Packaging # NDC Package Description Multilevel Packaging 1 0067-3998-85 1 TUBE In 1 CARTON contains a TUBE 1 24 g In 1 TUBE This package is contained within the CARTON (0067-3998-85) 2 0067-3998-42 1 TUBE In 1 CARTON contains a TUBE 2 12 g In 1 TUBE This package is contained within the CARTON (0067-3998-42) 3 0067-3998-15 1 TUBE In 1 CARTON contains a TUBE 3 15 g In 1 TUBE This package is contained within the CARTON (0067-3998-15) 4 0067-3998-28 1 TUBE In 1 CARTON contains a TUBE 4 28 g In 1 TUBE This package is contained within the CARTON (0067-3998-28) 5 0067-3998-30 1 TUBE In 1 CARTON contains a TUBE 5 30 g In 1 TUBE This package is contained within the CARTON (0067-3998-30) 6 0067-3998-40 1 TUBE In 1 CARTON contains a TUBE 6 40 g In 1 TUBE This package is contained within the CARTON (0067-3998-40) 7 0067-3998-36 36 g In 1 TUBE None 8 0067-3998-43 42 g In 1 TUBE None 9 0067-3998-54 54 g In 1 TUBE None

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
NDA	NDA020980	08/10/2005

Labeler - Novartis Consumer Health, Inc. (879821635)

Revised: 01/2010Novartis Consumer Health, Inc.

More Lamisil AT Cream resources

• Lamisil AT Cream Side Effects (in more detail)
• Lamisil AT Cream Use in Pregnancy & Breastfeeding
• Lamisil AT Cream Support Group
• 4 Reviews for Lamisil AT - Add your own review/rating

Compare Lamisil AT Cream with other medications

• Tinea Corporis
• Tinea Cruris
• Tinea Pedis

Triaminic Allergy-Congestion Elixir

Pronunciation: sue-do-eh-FED-rin/dex-troe-meth-OR-fan
Generic Name: Pseudoephedrine/Dextromethorphan
Brand Name: Examples include Dexatrex D and Tussin Pediatric

Triaminic Allergy-Congestion Elixir is used for:

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

Triaminic Allergy-Congestion Elixir is a decongestant and cough suppressant combination. It works by constricting blood vessels and reducing swelling in the nasal passages, which helps you to breathe more easily. The cough suppressant works in the brain to help decrease the cough reflex.

Do NOT use Triaminic Allergy-Congestion Elixir if:

• you are allergic to any ingredient in Triaminic Allergy-Congestion Elixir


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


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

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

Before using Triaminic Allergy-Congestion Elixir:

Some medical conditions may interact with Triaminic Allergy-Congestion Elixir. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

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


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


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


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


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

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

• Beta-blockers (eg, propranolol), COMT inhibitors (eg, tolcapone), furazolidone, indomethacin, MAO inhibitors (eg, phenelzine), or tricyclic antidepressants (eg, amitriptyline) because the risk of side effects from Triaminic Allergy-Congestion Elixir may be increased


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


• Bromocriptine because the risk of side effects may be increased by Triaminic Allergy-Congestion Elixir


• Guanadrel, guanethidine, mecamylamine, methyldopa, or reserpine because their effectiveness may be decreased by Triaminic Allergy-Congestion Elixir

This may not be a complete list of all interactions that may occur. Ask your health care provider if Triaminic Allergy-Congestion Elixir 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 Triaminic Allergy-Congestion Elixir:

Use Triaminic Allergy-Congestion Elixir as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• Triaminic Allergy-Congestion Elixir may be taken with or without food.


• 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 Triaminic Allergy-Congestion Elixir, 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 Triaminic Allergy-Congestion Elixir.

Important safety information:

• Triaminic Allergy-Congestion Elixir may cause dizziness or drowsiness. Do not drive, operate machinery, or do anything else that could be dangerous until you know how you react to Triaminic Allergy-Congestion Elixir. Using Triaminic Allergy-Congestion Elixir alone, with certain other medicines, or with alcohol may lessen your ability to drive or perform other potentially dangerous tasks.


• Do not take appetite suppressants while you are taking Triaminic Allergy-Congestion Elixir without checking with your doctor.


• Triaminic Allergy-Congestion Elixir contains pseudoephedrine. Before you begin taking any new prescription or nonprescription medicine, read the ingredients to see if it also contains pseudoephedrine. If it does or if you are uncertain, contact your doctor or pharmacist.


• Do NOT exceed the recommended dose or take Triaminic Allergy-Congestion Elixir for longer than prescribed without checking with your doctor.


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


• Triaminic Allergy-Congestion Elixir may interfere with certain lab test results. Make sure that all of your doctors and lab personnel know that you are taking Triaminic Allergy-Congestion Elixir.


• Before you have any medical or dental treatments, emergency care, or surgery, tell the doctor or dentist that you are using Triaminic Allergy-Congestion Elixir.


• Use Triaminic Allergy-Congestion Elixir with caution in the ELDERLY because they may be more sensitive to its effects.


• Caution is advised when using Triaminic Allergy-Congestion Elixir in CHILDREN because they may be more sensitive to its effects.


• PREGNANCY and BREAST-FEEDING: If you become pregnant while taking Triaminic Allergy-Congestion Elixir, discuss with your doctor the benefits and risks of using Triaminic Allergy-Congestion Elixir during pregnancy. It is unknown if Triaminic Allergy-Congestion Elixir is excreted in breast milk. Do not breast-feed while taking Triaminic Allergy-Congestion Elixir.

Possible side effects of Triaminic Allergy-Congestion Elixir:

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

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

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

Severe allergic reactions (rash; hives; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); difficulty urinating; fast or irregular heartbeat; hallucinations; seizures; severe dizziness, lightheadedness, or headache; tremor.

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

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 Triaminic Allergy-Congestion Elixir:

Store Triaminic Allergy-Congestion Elixir 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 Triaminic Allergy-Congestion Elixir out of the reach of children and away from pets.

General information:

• If you have any questions about Triaminic Allergy-Congestion Elixir, please talk with your doctor, pharmacist, or other health care provider.


• Triaminic Allergy-Congestion Elixir 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 Triaminic Allergy-Congestion Elixir. 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 Triaminic Allergy-Congestion resources

• Triaminic Allergy-Congestion Use in Pregnancy & Breastfeeding
• Triaminic Allergy-Congestion Drug Interactions
• Triaminic Allergy-Congestion Support Group
• 0 Reviews for Triaminic Allergy-Congestion - Add your own review/rating

Compare Triaminic Allergy-Congestion with other medications

• Cough and Nasal Congestion

Levophed

Generic Name: norepinephrine bitartrate

Dosage Form: injection, solution, concentrate
Levophed (Norepinephrine Bitartrate) 4 mg Injection, USP 4 mL Ampule

Description

Rx Only

Norepinephrine (sometimes referred to as l-arterenol/Levarterenol or l-norepinephrine) is a sympathomimetic amine which differs from epinephrine by the absence of a methyl group on the nitrogen atom. Norepinephrine Bitartrate is (-)-a-(aminomethyl)-3,4-dihydroxybenzyl alcohol tartrate (1:1) (salt) monohydrate and has the following structural formula:

Levophed is supplied in sterile aqueous solution in the form of the bitartrate salt to be administered by intravenous infusion following dilution. Norepinephrine is sparingly soluble in water, very slightly soluble in alcohol and ether, and readily soluble in acids. Each mL contains the equivalent of 1 mg base of norepinephrine, sodium chloride for isotonicity, and not more than 2 mg of

sodium metabisulfite as an antioxidant. It has a pH of 3 to 4.5. The air in the ampuls has been displaced by nitrogen gas.

Clinical Pharmacology

Levophed functions as a peripheral vasoconstrictor (alpha-adrenergic action) and as an inotropic stimulator of the heart and dilator of coronary arteries (beta-adrenergic action).

Indications and Usage

For blood pressure control in certain acute hypotensive states (e.g., pheochromocytomectomy, sympathectomy, poliomyelitis, spinal

anesthesia, myocardial infarction, septicemia, blood transfusion, and drug reactions).

As an adjunct in the treatment of cardiac arrest and profound hypotension.

Contraindications

Levophed should not be given to patients who are hypotensive from blood volume deficits except as an emergency measure to maintain coronary and cerebral artery perfusion until blood volume replacement therapy can be completed. If Levophed is continuously administered to maintain blood pressure in the absence of blood volume replacement, the following may occur: severe peripheral and visceral vasoconstriction, decreased renal perfusion and urine output, poor systemic blood flow despite “normal” blood pressure, tissue hypoxia, and lactate acidosis.

Levophed should also not be given to patients with mesenteric or peripheral vascular thrombosis (because of the risk of increasing ischemia and extending the area of infarction) unless, in the opinion of the attending physician, the administration of Levophed is necessary as a life-saving procedure. Cyclopropane and halothane anesthetics increase cardiac autonomic irritability and therefore seem to sensitize the myocardium to the action of intravenously administered epinephrine or norepinephrine. Hence, the use of Levophed during cyclopropane and halothane anesthesia is generally considered contraindicated because of the risk of producing ventricular tachycardia or fibrillation. The same type of cardiac arrhythmias may result from the use of Levophed in patients with profound hypoxia or hypercarbia.

Precautions

General

Avoid Hypertension: Because of the potency of Levophed and because of varying response to pressor substances, the possibility always exists that dangerously high blood pressure may be produced with overdoses of this pressor agent. It is desirable, therefore, to record the blood pressure every two minutes from the time administration is started until the desired blood pressure is obtained, then every five minutes if administration is to be continued. The rate of flow must be watched constantly, and the patient should never be left unattended while receiving Levophed. Headache may be a symptom of hypertension due to overdosage.

Site of Infusion: Whenever possible, infusions of Levophed should be given into a large vein, particularly an antecubital vein because, when administered into this vein, the risk of necrosis of the overlying skin from prolonged vasoconstriction is apparently very slight. Some authors have indicated that the femoral vein is also an acceptable route of administration. A catheter tie-in technique should be avoided, if possible, since the obstruction to blood flow around the tubing may cause stasis and increased local concentration of the drug. Occlusive vascular diseases (for example, atherosclerosis, arteriosclerosis, diabetic endarteritis, Buerger’s disease) are more likely to occur in the lower than in the upper extremity. Therefore, one should avoid the veins of the leg in elderly patients or in those suffering from such disorders. Gangrene has been reported in a lower extremity when infusions of Levophed were given in an ankle vein.

Extravasation:The infusion site should be checked frequently for free flow. Care should be taken to avoid extravasation of Levophed into the tissues, as local necrosis might ensue due to the vasoconstrictive action of the drug. Blanching along the course of the infused vein, sometimes without obvious extravasation, has been attributed to vasa vasorum constriction with increased permeability of the vein wall, permitting some leakage. This also may progress on rare occasions to superficial slough, particularly during infusion into leg veins in elderly patients or in those suffering from obliterative vascular disease. Hence, if blanching occurs, consideration should be given to the advisability of changing the infusion site at intervals to allow the effects of local vasoconstriction to subside.

IMPORTANT #Antidote for Extravasation Ischemia: To prevent sloughing and necrosis in areas in which extravasation has taken place, the area should be infiltrated as soon as possible with 10 mL to 15 mL of saline solution containing from 5 mg to 10 mg of Regitine® (brand of phentolamine), an adrenergic blocking agent. A syringe with a fine hypodermic needle should be used, with the solution being infiltrated liberally throughout the area, which is easily identified by its cold, hard, and pallid appearance. Sympathetic blockade with phentolamine causes immediate and conspicuous local hyperemic changes if the area is infiltrated within 12 hours. Therefore, phentolamine should be given as soon as possible after the extravasation is noted.

Drug Interactions:

Cyclopropane and halothane anesthetics increase cardiac autonomic irritability and therefore seem to sensitize the myocardium to the action of intravenously administered epinephrine or norepinephrine. Hence, the use of Levophed during cyclopropane and halothane anesthesia is generally considered contraindicated because of the risk of producing ventricular tachycardia or fibrillation. The same type of cardiac arrhythmias may result from the use of Levophed in patients with profound hypoxia or hypercarbia. Levophed should be used with extreme caution in patients receiving monoamine oxidase inhibitors (MAOI) or antidepressants of the triptyline or imipramine types, because severe, prolonged hypertension may result.


Carcinogenesis, Mutagenesis, Impairment of Fertility:

Studies have not been performed.


Pregnancy Category C:

Animal reproduction studies have not been conducted with Levophed. It is also not known whether Levophed can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Levophed should be given to a pregnant woman only if clearly needed.


Nursing Mothers:

It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when Levophed is administered to a nursing woman.


Pediatric Use:

Safety and effectiveness in pediatric patients has not been established.


Geriatric Use:

Clinical studies of Levophed did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Other reported clinical experience has not identified differences in responses between the elderly and younger patients. In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy. Levophed infusions should not be administered into the veins in the leg in elderly patients (see PRECAUTIONS, General).

Adverse Reactions

The following reactions can occur:

Body As A Whole: Ischemic injury due to potent vasoconstrictor action and tissue hypoxia.

Cardiovascular System: Bradycardia, probably as a reflex result of a rise in blood pressure, arrhythmias.

Nervous System: Anxiety, transient headache.

Respiratory System: Respiratory difficulty.

Skin and Appendages: Extravasation necrosis at injection site.

Prolonged administration of any potent vasopressor may result in plasma volume depletion which should be continuously corrected by appropriate fluid and electrolyte replacement therapy. If plasma volumes are not corrected, hypotension may recur when Levophed is discontinued, or blood pressure may be maintained at the risk of severe peripheral and visceral vasoconstriction (e.g., decreasedrenal perfusion) with diminution in blood flow and tissue perfusion with subsequent tissue hypoxia and lactic acidosis and possible  ischemic injury. Gangrene of extremities has been rarely reported. Overdoses or conventional doses in hypersensitive persons (e.g., hyperthyroid patients) cause severe hypertension with violent headache, photophobia, stabbing retrosternal pain, pallor, intense sweating, and vomiting.

Overdosage

Overdosage with Levophed may result in headache, severe hypertension, reflex bradycardia, marked increase in peripheral resistance, and decreased cardiac output. In case of accidental overdosage, as evidenced by excessive blood pressure elevation, discontinue Levophed until the condition of the patient stabilizes.

Dosage and Administration

Norepinephrine Bitartrate Injection is a concentrated, potent drug which must be diluted in dextrose containing solutions prior to infusion. An infusion of Levophed should be given into a large vein (see PRECAUTIONS).

Restoration of Blood Pressure in Acute Hypotensive States

Blood volume depletion should always be corrected as fully as possible before any vasopressor is administered. When, as an emergency measure, intraaortic pressures must be maintained to prevent cerebral or coronary artery ischemia, Levophed can be administered before and concurrently with blood volume replacement.

Diluent: Levophed should be diluted in 5 percent dextrose injection or 5 percent dextrose and sodium chloride injections. These dextrose containing fluids are protection against significant loss of potency due to oxidation. Administration in saline solution alone is not recommended. Whole blood or plasma, if indicated to increase blood volume, should be administered separately (for example, by use of a Y-tube and individual containers if given simultaneously).

Average Dosage: Add a 4 mL ampul (4 mg) of Levophed to 1,000 mL of a 5 percent dextrose containing solution. Each mL of this dilution contains 4 mcg of the base of Levophed. Give this solution by intravenous infusion. Insert a plastic intravenous catheter through a suitable bore needle well advanced centrally into the vein and securely fixed with adhesive tape, avoiding, if possible, a catheter tie-in technique as this promotes stasis. An IV drip chamber or other suitable metering device is essential to permit an accurate estimation of the rate of flow in drops per minute. After observing the response to an initial dose of 2 mL to 3 mL (from 8 mcg to 12 mcg of base) per minute, adjust the rate of flow to establish and maintain a low normal blood pressure (usually 80 mm Hg to 100 mm Hg systolic) sufficient to maintain the circulation to vital organs. In previously hypertensive patients, it is recommended

that the blood pressure should be raised no higher than 40 mm Hg below the preexisting systolic pressure. The average maintenance dose ranges from 0.5 mL to 1 mL per minute (from 2 mcg to 4 mcg of base).

High Dosage: Great individual variation occurs in the dose required to attain and maintain an adequate blood pressure. In all cases, dosage of Levophed should be titrated according to the response of the patient. Occasionally much larger or even enormous daily doses (as high as 68 mg base or 17 ampuls) may be necessary if the patient remains hypotensive, but occult blood volume depletion should always be suspected and corrected when present. Central venous pressure monitoring is usually helpful in detecting and treating this situation.

Fluid Intake: The degree of dilution depends on clinical fluid volume requirements. If large volumes of fluid (dextrose) are needed at a flow rate that would involve an excessive dose of the pressor agent per unit of time, a solution more dilute than 4 mcg per mL should be used. On the other hand, when large volumes of fluid are clinically undesirable, a concentration greater than 4 mcg per mL may be necessary.

Duration of Therapy: The infusion should be continued until adequate blood pressure and tissue perfusion are maintained without therapy. Infusions of Levophed should be reduced gradually, avoiding abrupt withdrawal. In some of the reported cases of vascular collapse due to acute myocardial infarction, treatment was required for up to six days.

Adjunctive Treatment in Cardiac Arrest

Infusions of Levophed are usually administered intravenously during cardiac resuscitation to restore and maintain an adequate blood pressure after an effective heartbeat and ventilation have been established by other means. [Levophed’s powerful betaadrenergic stimulating action is also thought to increase the strength and effectiveness of systolic contractions once they occur.]

Average Dosage: To maintain systemic blood pressure during the management of cardiac arrest, Levophed is used in the same manner as described under Restoration of Blood Pressure in Acute Hypotensive States. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to use, whenever solution and container permit.

Do not use the solution if its color is pinkish or darker than slightly yellow or if it contains a precipitate. Avoid contact with iron salts, alkalis, or oxidizing agents.

How Supplied

Levophed, norepinephrine bitartrate injection, USP, contains the equivalent of 4 mg base of Levophed per each 4 mL ampul (1 mg/mL).

Supplied as:

Ampuls of 4 mL in boxes of 10 (List 1443)

Store at 25°C (77°F); excursions permitted to 15 - 30°C (59 - 86°F).

Protect from light.

Regitine, trademark, CIBA Pharmaceuticals Company.

©Hospira 2004

EN-0198

Printed in USA

HOSPIRA, INC., LAKE FOREST, IL 60045, USA

Sample Package Label

Levophed  norepinephrine bitartrate  injection, solution, concentrate

Product Information Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 52584-443 (0409-1443) Route of Administration INTRAVENOUS DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Norepinephrine Bitartrate (Norepinephrine ) Norepinephrine Bitartrate 1 mg  in 1 mL

Inactive Ingredients Ingredient Name Strength No Inactive Ingredients Found

Product Characteristics Color      Score      Shape Size Flavor Imprint Code Contains

Packaging # NDC Package Description Multilevel Packaging 1 52584-443-04 1 AMPULE In 1 BAG contains a AMPULE 1 4 mL In 1 AMPULE This package is contained within the BAG (52584-443-04)

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
NDA	NDA007513	03/01/2010

Labeler - General Injectables & Vaccines, Inc (108250663)

Revised: 08/2011General Injectables & Vaccines, Inc

More Levophed resources

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

Compare Levophed with other medications

• Hypotension
• Shock

Hibistat

Generic Name: chlorhexidine (Topical application route)

klor-HEX-i-deen

Commonly used brand name(s)

In the U.S.

• Betasept


• Biopatch w/Chlorhexidine Gluconate


• Chlorostat


• Dyna-Hex


• Dyna-Hex2


• Hibiclens


• Hibistat


• Operand Chg Surgical Scrub Brush


• Operand Chlorhexidine Gluconate


• Operand Closed Loop Chg Scrub

In Canada

• Stanhexidine Solution


• Stanley Chlorhexidine Tinted


• Stanley Chlorhexidine Untinted

Available Dosage Forms:

• Dressing


• Gel/Jelly


• Lotion


• Solution


• Liquid


• Pad


• Sponge


• Cream

Therapeutic Class: Antibacterial Cleansing Agent

Uses For Hibistat

Chlorhexidine belongs to a group of medicines called antiseptic antibacterial agents. It is used to clean the skin after an injury, before surgery, or before an injection. Chlorhexidine is also used to clean the hands before a procedure. It works by killing or preventing the growth of bacteria on the skin.

Before Using Hibistat

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

Because of chlorhexidine's potential for causing excessive skin irritation and the risk of increased absorption through the skin, use in children less than 2 months of age is not recommended.

Geriatric

No information is available on the relationship of age to the effects of chlorhexidine 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:

• Deep or open skin wounds—Some products should not be used for this condition. Use the medicine only as directed by your doctor.

Proper Use of chlorhexidine

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

Some of the chlorhexidine products will be used in a hospital or clinic setting. The medicine will be applied by a nurse or other trained health professional.

You may be instructed to use this medicine at home. 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 irritation of the skin.

Different forms of the medicine are used in different ways. Be sure you understand the directions for the product you are given before you use it. Ask your doctor or pharmacist if you have any questions.

Follow your doctor's instructions about how to clean and care for your skin before and after you use this medicine. Make sure you understand all of the directions, and ask questions if you find something is not clear.

Chlorhexidine should only be used on the skin. Do not swallow it or get it in the eyes, ears, mouth, or nose. Do not use it on the genital area (sex organs) or anal area. If it does get on these areas, rinse it off right away.

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 topical dosage form (hand rinse or wipe, solution, or swabstick applicator):
  
  • To clean the hands (eg, Hibistat®):
    
    • The Hibistat® product contains large amounts of alcohol (70%) and is flammable. Apply the medicine in a well-ventilated place and do not use it while you are smoking.
    
    
    • Adults, teenagers, and children 2 months of age and older:
      
      • Wash your hands with soap and water. Dry your hands with a towel.
      
      
      • Rub the hands with the hand wipe for 15 seconds. Make sure to use the wipe under the fingernails and between the fingers. The medicine will dry quickly so you should not use a towel for drying. Do not wet your hands a second time.
      
      
      • Pour 1 teaspoonful (5 milliliters) of the hand rinse in your cupped hand. Rub the hands together for 15 seconds. Make sure to apply the rinse under the fingernails and between the fingers. The medicine will dry quickly so you should not use a towel for drying. Do not wet your hands a second time.
      
      
    
    
    • Children younger than 2 months of age—Use is not recommended.
    
    
  
  
  • To clean the skin or a wound (eg, Betasept®, Hibiclens®):
    
    • Adults, teenagers, and children 2 months of age and older—Rinse the area to be cleaned with water. Apply the smallest amount of liquid needed to cover the skin or wound area and wash gently. Thoroughly rinse the area again with water.
    
    
    • Children younger than 2 months of age—Use is not recommended.
    
    
  
  
  • To use before surgery or an injection (eg, Chloraprep®):
    
    • The Chloraprep® product contains large amounts of alcohol (70%) and is flammable. Do not use it on skin areas that have cuts or scrapes. Apply the medicine in a well-ventilated place and do not use it while you are smoking.
    
    
    • Adults, teenagers, and children 2 months of age and older:
      
      • Open the pouch and use the handle to remove the swabstick applicator. Do not touch the applicator tip. Rub the applicator on the skin with the flat side against the skin. Use a back and forth motion for 30 seconds.
      
      
      • Make sure the skin is completely wet. Let the skin air dry for one minute. Do not use a towel for drying.
      
      
      • Do not cover the treated area until the skin is completely dry. This is usually one minute or longer for hairless skin. If you must apply the medicine to a hairy area of the body, wipe the area with a towel to remove extra medicine.
      
      
    
    
    • Children younger than 2 months of age—Use is not recommended.
    
    
  
  

Storage

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

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

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

The Chloraprep® and Hibistat® products contain large amounts of alcohol (70%) and are flammable. Do not store them near a flame, heater, or electrical device.

Precautions While Using Hibistat

Check with your doctor if your skin problem becomes worse. Call your doctor if you have skin irritation that does not go away, such as redness, itching, or burning in the area where you used this medicine.

This medicine should not be used for an extended period of time on large areas of the body. Follow your doctor's instructions about how long to use this medicine.

This medicine may cause serious and permanent injury when placed in the eyes, ears, or mouth. Carefully follow all instructions before using this medicine to prevent serious side effects.

This medicine may cause a brown stain on clothing when chlorine is also present. These stains may not be removed by regular washing. Use only non-chlorine products to wash or bleach fabrics exposed to this medicine. If the medicine has directions on the package about washing fabrics, follow them carefully.

The Chloraprep® and Hibistat® products contain large amounts of alcohol (70%) and are flammable. Do not use them or store them near a flame, heater, or electrical device. Do not use the medicine while you are smoking. Apply the medicine in a well-ventilated place.

Hibistat 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, itching, peeling, skin rash, redness, swelling, or other signs of irritation on the skin


• swelling of the face, hands, or feet


• trouble breathing

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: Hibistat side effects (in more detail)

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More Hibistat resources

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

• Hibistat Concise Consumer Information (Cerner Multum)


• Betasept Liquid MedFacts Consumer Leaflet (Wolters Kluwer)


• Betasept Concise Consumer Information (Cerner Multum)


• Peridex Prescribing Information (FDA)


• Peridex oral rinse Concise Consumer Information (Cerner Multum)


• Peridex Solution MedFacts Consumer Leaflet (Wolters Kluwer)


• PerioGard Prescribing Information (FDA)


• Periochip Prescribing Information (FDA)

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