Quinoderm 10% / 0.5% w / w Cream

1. Name Of The Medicinal Product

Quinoderm 10% / 0.5% w/w Cream

2. Qualitative And Quantitative Composition

Benzoyl Peroxide, hydrous	10.0% w/w
Potassium Hydroxyquinoline Sulphate	0.5% w/w

Excipients: Also includes cetostearyl alcohol, approx 0.825% w/w

For full list of excipients, see section 6.1

3. Pharmaceutical Form

Quinoderm Cream is a creamy white astringent vanishing cream. It is intended for topical use only.

4. Clinical Particulars

4.1 Therapeutic Indications

Acne vulgaris, acneform eruptions, folliculitis.

4.2 Posology And Method Of Administration

Route of administration

For topical use only.

Adults, children and the elderly

By gentle massage over all the affected area two or three times daily.

4.3 Contraindications

Acne rosacea. Patients with known sensitivity to either of the active ingredients should not use Quinoderm Cream.

4.4 Special Warnings And Precautions For Use

Contact with mouth and eyes should be avoided. Care should be taken to avoid contact with dyed fabrics as this product may adversely affect dye fastness.

In a few isolated cases, overreaction to Quinoderm Cream may occur. To minimise this possibility, select a small area of skin behind the ear, apply the cream and leave for 12 hours. If severe irritation or pronounced redness occurs, do not proceed with treatment.

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

Benzoyl Peroxide is an oxidising agent. Hence, Quinoderm Cream should not be used at the same time as other topical agents which would react with an oxidising agent.

4.6 Pregnancy And Lactation

Quinoderm Cream is not contra-indicated in pregnancy or lactation.

4.7 Effects On Ability To Drive And Use Machines

Not applicable.

4.8 Undesirable Effects

Skin & Subcutaneous Tissue Disorders

Local irritation or inflammation may result; in such cases use should be interrupted or frequency reduced. Itch or rash may occur in which instance treatment should cease and a Physician or Pharmacist consulted.

4.9 Overdose

Not applicable.

5. Pharmacological Properties

5.1 Pharmacodynamic Properties

Pharmacotherapeutic Group: Peroxides, Benzoyl Peroxide

ATC Code: D10AE01

Potassium Hydroxyquinoline Sulphate – not known.

The combination of the mild keratolytic properties of benzoyl peroxide and the antibacterial and antifungal properties of potassium hydroxyquinoline sulphate in a specially formulated bland water-miscible base make this preparation valuable in the treatment of acne vulgaris, acneform eruptions and folliculitis.

5.2 Pharmacokinetic Properties

Not applicable.

5.3 Preclinical Safety Data

None stated.

6. Pharmaceutical Particulars

6.1 List Of Excipients

Lactic Acid,

White Soft Paraffin,

Edetic Acid,

Sodium Dihydrogen Phosphate Dihydrate ,

Maize Starch,

Cetostearyl Alcohol

Sodium Cetostearyl Sulphate

Macrogol 40 Castor Oil

Purified Water.

6.2 Incompatibilities

Any topical agent that would react with an oxidising agent

6.3 Shelf Life

Three years.

6.4 Special Precautions For Storage

Do not store above 25ºC. Do not refrigerate.

6.5 Nature And Contents Of Container

Quinoderm Cream is available in heat sealed low density polyethylene tubes with flush fitting cap containing 25 g, 40g and 50 g of product. Each tube is cartoned and contains a patient information leaflet.

Not all pack sizes may be marketed.

6.6 Special Precautions For Disposal And Other Handling

None.

7. Marketing Authorisation Holder

Ferndale Pharmaceuticals Ltd,

12 York Place,

Leeds,

LS1 2DS,

United Kingdom.

8. Marketing Authorisation Number(S)

PL 20685/0022

9. Date Of First Authorisation/Renewal Of The Authorisation

23 April 2004

10. Date Of Revision Of The Text

05 November 2010

11 DOSIMETRY

n/a

12 INSTRUCTIONS FOR PREPARATION OF RADIOPHARMACEUTICALS (IF APPLICABLE)

n/a

Florinef Acetate

Generic Name: fludrocortisone (FLOO droe KOR ti sone)

Brand Names: Florinef Acetate

What is Florinef Acetate (fludrocortisone)?

Fludrocortisone is in a class of drugs called steroids. Fludrocortisone prevents the release of substances in the body that cause inflammation.

Fludrocortisone is used to treat conditions in which the body does not produce enough of its own steroids, such as Addison's disease, and salt-losing adrenogenital syndrome.

Fludrocortisone may also be used for other purposes not listed in this medication guide.

What is the most important information I should know about Florinef Acetate (fludrocortisone)?

You should not use this medication if you are allergic to fludrocortisone, or if you have a fungal infection anywhere in your body.

Before taking fludrocortisone, tell your doctor about all of your medical conditions, and about all other medicines you are using. There are many other diseases that can be affected by steroid use, and many other medicines that can interact with steroids.

Your steroid medication needs may change if you have any unusual stress such as a serious illness, fever or infection, or if you have surgery or a medical emergency. Tell your doctor about any such situation that affects you during treatment.

Steroid medication can weaken your immune system, making it easier for you to get an infection or worsening an infection you already have or have recently had. Tell your doctor about any illness or infection you have had within the past several weeks.

Avoid being near people who are sick or have infections. Call your doctor for preventive treatment if you are exposed to chicken pox or measles. These conditions can be serious or even fatal in people who are using steroid medication.

Do not receive a "live" vaccine while you are taking fludrocortisone. Vaccines may not work as well while you are taking a steroid.

Do not stop using fludrocortisone suddenly, or you could have unpleasant withdrawal symptoms. Talk to your doctor about how to avoid withdrawal symptoms when stopping the medication. Carry an ID card or wear a medical alert bracelet stating that you are taking a steroid, in case of emergency.

What should I discuss with my healthcare provider before taking Florinef Acetate (fludrocortisone)?

You should not use this medication if you are allergic to fludrocortisone, or if you have a fungal infection anywhere in your body.

Steroid medication can weaken your immune system, making it easier for you to get an infection. Steroids can also worsen an infection you already have, or reactivate an infection you recently had. Before taking this medication, tell your doctor about any illness or infection you have had within the past several weeks.

Other medical conditions you should tell your doctor about before taking fludrocortisone include:

• 
  

  liver disease (such as cirrhosis);

  
  


• 
  

  kidney disease;

  
  


• 
  

  a thyroid disorder;

  
  


• 
  

  diabetes;

  
  


• 
  

  a history of malaria;

  
  


• 
  

  tuberculosis;

  
  


• 
  

  osteoporosis;

  
  


• 
  

  a muscle disorder such as myasthenia gravis;

  
  


• 
  

  glaucoma or cataracts;

  
  


• 
  

  herpes infection of the eyes;

  
  


• 
  

  stomach ulcers, ulcerative colitis, or diverticulitis;

  
  


• 
  

  depression or mental illness;

  
  


• 
  

  congestive heart failure; or

  
  


• 
  

  high blood pressure

  
  

If you have any of these conditions, you may need a dose adjustment or special tests to safely take fludrocortisone.

FDA pregnancy category C. This medication may be harmful to an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant during treatment. Fludrocortisone can pass into breast milk and may harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby.

How should I take Florinef Acetate (fludrocortisone)?

Take this medication exactly as it was prescribed for you. Do not take the medication in larger amounts, or take it for longer than recommended by your doctor. Follow the directions on your prescription label.

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

Your steroid medication needs may change if you have unusual stress such as a serious illness, fever or infection, or if you have surgery or a medical emergency. Tell your doctor about any such situation that affects you.

This medication can cause you to have unusual results with certain medical tests. Tell any doctor who treats you that you are using fludrocortisone.

Do not stop using fludrocortisone suddenly, or you could have unpleasant withdrawal symptoms. Talk to your doctor about how to avoid withdrawal symptoms when stopping the medication. Carry an ID card or wear a medical alert bracelet stating that you are taking a steroid, in case of emergency. Any doctor, dentist, or emergency medical care provider who treats you should know that you are taking steroid medication. Store fludrocortisone at room temperature away from moisture and heat.

What happens if I miss a dose?

Take the missed dose as soon as you remember. If it is almost time for your next dose, wait until then to take the medicine and skip the missed dose. Do not take extra medicine to make up the missed dose.

What happens if I overdose?

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

Overdose symptoms may include swelling, weight gain, feeling short of breath, confusion, uneven heart rate, increased thirst or urination, leg discomfort, and muscle pain or weakness.

What should I avoid while taking Florinef Acetate (fludrocortisone)?

Avoid being near people who are sick or have infections. Call your doctor for preventive treatment if you are exposed to chicken pox or measles. These conditions can be serious or even fatal in people who are using steroid medication.

Do not receive a "live" vaccine while you are being treated with fludrocortisone. Vaccines may not work as well while you are taking a steroid.

Florinef Acetate (fludrocortisone) side effects

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

• 
  

  problems with your vision;

  
  


• 
  

  swelling, rapid weight gain, feeling short of breath;

  
  


• 
  

  severe depression, unusual thoughts or behavior, seizure (convulsions);

  
  


• 
  

  bloody or tarry stools, coughing up blood;

  
  


• 
  

  pancreatitis (severe pain in your upper stomach spreading to your back, nausea and vomiting, fast heart rate);

  
  


• 
  

  low potassium (confusion, uneven heart rate, extreme thirst, increased urination, leg discomfort, muscle weakness or limp feeling); or

  
  


• 
  

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

  
  

Less serious side effects may include:

• 
  

  sleep problems (insomnia), mood changes;

  
  


• 
  

  acne, dry skin, thinning skin, bruising or discoloration;

  
  


• 
  

  slow wound healing;

  
  


• 
  

  increased sweating;

  
  


• 
  

  headache, dizziness, spinning sensation;

  
  


• 
  

  nausea, stomach pain, bloating; or

  
  


• 
  

  changes in the shape or location of body fat (especially in your arms, legs, face, neck, breasts, and waist).

  
  

This is not a complete list of side effects and others may occur. Tell your doctor about any unusual or bothersome side effect. You may report side effects to FDA at 1-800-FDA-1088.

What other drugs will affect Florinef Acetate (fludrocortisone)?

There are many other medicines that can interact with steroids. Below is only a partial list of these medicines:

• 
  

  aspirin (taken on a daily basis or at high doses);

  
  


• 
  

  amphotericin B (Fungizone);

  
  


• 
  

  a diuretic (water pill);

  
  


• 
  

  digoxin (digitalis, Lanoxin);

  
  


• 
  

  phenytoin (Dilantin);

  
  


• 
  

  rifampin (Rifadin, Rifater, Rifamate, Rimactane);

  
  


• 
  

  birth control pills or hormone replacement therapy;

  
  


• 
  

  a blood thinner such as warfarin (Coumadin);

  
  


• 
  

  insulin or diabetes medications you take by mouth;

  
  


• 
  

  an anabolic steroid such as oxymetholone (Anadrol-50), nandrolone (Durabolin, others), and others; or

  
  


• 
  

  a barbiturate such as amobarbital (Amytal), butabarbital (Butisol), mephobarbital (Mebaral), secobarbital (Seconal), or phenobarbital (Luminal, Solfoton).

  
  

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

More Florinef Acetate resources

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

• Florinef Acetate Monograph (AHFS DI)


• Florinef Acetate Advanced Consumer (Micromedex) - Includes Dosage Information


• Fludrocortisone Prescribing Information (FDA)


• Fludrocortisone MedFacts Consumer Leaflet (Wolters Kluwer)

Compare Florinef Acetate with other medications

• Addison's Disease
• Adrenogenital Syndrome
• Dysautonomia
• Postural Orthostatic Tachycardia Syndrome

Where can I get more information?

• Your pharmacist can provide more information about fludrocortisone.

See also: Florinef Acetate side effects (in more detail)

Selexid Tablets

Selexid Tablets

Pivmecillinam hydrochloride

Please read all of this leaflet carefully before you start taking this medicine.

• Keep this leaflet. You may need to read it again.


• If you have any further questions, ask your doctor or pharmacist.


• This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.


• If any of the side effects become serious, or you notice any side effects not listed in this leaflet please tell your doctor or pharmacist.


• In this leaflet Selexid Tablets will be called Selexid.

In this leaflet:

• 1. What Selexid is and what it is used for


• 2. Before you take Selexid


• 3. How to take Selexid


• 4. Possible side effects


• 5. How to store Selexid


• 6. Further information

What Selexid Is And What It Is Used For

Selexid belongs to a group of medicines called penicillins. It is a type of antibiotic.

Selexid works by killing germs (bacteria) that cause infections.

If the infection is not treated germs can continue to grow in your body. The infection will make you feel very unwell, and could even be life-threatening.

Selexid is used to treat:

• Infections of the bladder or tubes leading from the kidneys (urinary tract infections).


• Infections caused by a bacteria called Salmonella (salmonellosis).

Before You Take Selexid

Do not take Selexid

• If you are allergic (hypersensitive) to pivmecillinam or any of the other ingredients in your medicine. You can find a list of these ingredients in section 6 of this leaflet.


• If you are allergic (hypersensitive) to other antibiotics. Such antibiotics include penicillin or cephalosporins.


• If you know that your food pipe has become narrow.


• If you know that you have any blockages in your digestive system.


• If you know you have any condition that may reduce the amount of a substance called carnitine in your body. Such conditions include primary carnitine deficiency or kidney dialysis.

Do not give this medicine to a baby under three months old.

Take special care with Selexid

Before you take Selexid tell your doctor:

• If you have problems with your kidneys.


• If you know that you have a condition called porphyria.


• If you are taking other medicines used to treat epilepsy, called valproic acid or valproate.


• If you are taking another antibiotic called pivampicillin.


• If you have recently taken a course of Selexid.


• If you have been taking Selexid for a long time already.

If you take Selexid for a long time your doctor may take regular blood tests. This is to check if your kidneys and liver are working properly.

Taking other medicines

Please tell your doctor or pharmacist if you are taking, or have recently taken any other medicines. This includes any medicines which you have bought without a prescription.

You must tell your doctor or pharmacist if you are taking any of the following medicines:

• Methotrexate: for arthritis or psoriasis. You may need to take a different dose of methotrexate.


• Probenecid: for gout. This may increase the effect of Selexid.


• Valproic acid or valproate: for epilepsy.


• Any other antibiotic: for treating an infection. This may increase the effect of Selexid.

Taking Selexid with food and drink

Tablets must be swallowed whole during or immediately after a meal with at least half a glass of water, while sitting or standing.

It is important to take your medicine with plenty of liquid. This will stop you getting mouth ulcers or ulcers in your food pipe. Please read section 4 of this leaflet so you can spot any signs this may be happening to you.

Pregnancy and breast-feeding

Please ask your doctor or pharmacist for advice before taking Selexid:

• If you are pregnant, or think you are pregnant.


• If you are breast-feeding.

Tell your doctor if you become pregnant while taking this medicine.

Driving and using machines

Usually your medicine may have very little effect on your ability to drive or use machines. Check with your doctor if you feel any side effect that may stop you from driving or using machines.

How To Take Selexid

Always use Selexid exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.

How much Selexid to take

Your doctor will tell you how many tablets to take, or give to your child. Your doctor will tell you how many times each day to take your medicine.

You should take the medicine at equally spaced times in the day.

Remember to always swallow the tablets whole during or immediately after a meal and with at least half a glass of water, while sitting or standing.

It is very important to take all the medicine your doctor has told you to take.

Urinary Tract Infections:

Adults and children weighing more than 40 kg:

• Acute infection:
  
  The usual starting dose is 2 tablets taken immediately. Then take one tablet every 8 hours. Continue until you have taken all 10 tablets in the pack.


• Repeated infection:
  
  The usual dose is 6-8 tablets each day. Take two tablets 3 or 4 times each day.

For other type of infections or for children weighing less than 40 kg:

Your doctor will prescribe the right dose for you.

If you take more Selexid than you should

Tell your doctor straight away. You may need to stop taking this medicine.

You may be sick, or feel sick, or get an upset stomach.

If you forget to take Selexid

If you forget to take your medicine, take it as soon as you remember. If you can, take it during or immediately after a meal, but always take it with half a glass of water, while sitting or standing. Then take the next dose at the usual time.

If you stop taking Selexid

It is very important to take all the medicine that your doctor has told you to take. You must finish this medicine even if you feel better. You must do this because otherwise you may feel ill again.

If you have any further questions about taking this medicine, please ask your doctor or pharmacist.

Selexid Tablets Side Effects

Like all medicines, Selexid can cause side effects, although not everybody gets them.

Important side effects to look out for:

You must get urgent medical help if you have any of the following symptoms. You may be having an allergic reaction:

• 
  You have difficulty breathing.
  


• 
  Your face or throat swell.
  


• 
  Your skin develops a severe rash or areas of sudden swelling.
  

Other possible side effects:

Common side effects are digestive and skin problems.

Very rare side effects are allergic reactions, blood problems, and liver problems.

Digestive problems:

• Being sick (vomiting).


• Feeling sick (nausea).


• Indigestion.


• Stomach pain.


• Diarrhoea. This may be because your bowel is inflamed (colitis).


• Trouble chewing or swallowing your food. This may be due to mouth ulcers or ulcers in your food pipe from taking the tablets with insufficient fluids.

Skin problems:

• Rash.


• Hives (urticaria).


• Itching skin (pruritus).

Liver problems:

• Yellowing of the skin or eyes.


• Unusually dark urine.


• Small changes in blood test results. Your doctor can explain this more.

Blood problems:

• Bruising or bleeding more easily.


• Getting a fever or infections more often.

Changes to certain cells found in your blood may cause these symptoms.

Other problems:

• Muscle weakness or muscle loss.


• Tiredness or lack of energy.

Not enough of a substance called carnitine in your body may cause these symptoms.

If any of the side effects become serious, or you notice any side effects not listed in this leaflet, tell your doctor or pharmacist.

How To Store Selexid

• Keep out of the reach and the sight of children.


• Do not use the tablets after the expiry date on the carton. The expiry date is the last day of that month.


• Store below 25°C in a dry place.

Medicines should not be thrown away in waste water or in household waste. Please ask your pharmacist how to throw away any medicine you do not need anymore. If you do this you will help protect the environment.

Further Information

What Selexid contains

• The active ingredient is pivmecillinam hydrochloride.
  
  Selexid contains 200 milligrams of pivmecillinam hydrochloride in each tablet.


• The other ingredients are cellulose microcrystalline, hydroxypropylcellulose, magnesium stearate, hypromellose, simethicone and synthetic paraffin.

What Selexid looks like and contents of the pack

Selexid is a white tablet. There is a picture of a lion on one side of the tablet. The other side has 137 written on it.

Selexid comes in blister packs of 10 tablets.

Marketing Authorisation Holder / Manufacturer

Marketing Authorisation Holder:

LEO Laboratories Limited

Princes Risborough

Bucks

HP27 9RR

UK

Manufacturer:

Recipharm Strängnäs AB

Mariefredsvägen 35

S-645 41 Strängnäs

Sweden

This leaflet was last revised in November 2009.

This leaflet was last approved in January 2010.

Registered Trade Mark

LEO

023719-02

063339

samarium sm 153 lexidronam Intravenous

sa-MAR-ee-um Sm 153 lex-ID-roe-nam

Commonly used brand name(s)

In the U.S.

• Quadramet

Available Dosage Forms:

• Injectable


• Solution

Therapeutic Class: Radiopharmaceutical, Antineoplastic

Uses For samarium sm 153 lexidronam

Samarium Sm 153 lexidronam is a radiopharmaceutical. Radiopharmaceuticals are radioactive agents that may be used to diagnose some diseases by studying the function of the body's organs or to treat certain diseases.

Samarium Sm 153 lexidronam is used to help relieve the bone pain that may occur with certain kinds of cancer. The radioactive samarium is taken up in the bone cancer area and gives off radiation that helps provide relief of pain.

Samarium Sm 153 lexidronam is to be given only by or under the direct supervision of a doctor with specialized training in nuclear medicine or radiation oncology.

Before Using samarium sm 153 lexidronam

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 samarium sm 153 lexidronam, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to samarium sm 153 lexidronam 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

Studies on samarium sm 153 lexidronam have been done only in adult patients, and there is no specific information comparing use of samarium Sm 153 lexidronam in children with use in other age groups.

Geriatric

Samarium Sm 153 lexidronam has been used in older people and has not been shown to cause different side effects or problems in older people than it does in younger adults.

Pregnancy

	Pregnancy Category	Explanation
All Trimesters	D	Studies in pregnant women have demonstrated a risk to the fetus. However, the benefits of therapy in a life threatening situation or a serious disease, may outweigh the potential risk.

Breast Feeding

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

Interactions with Medicines

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. 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 samarium Sm 153 lexidronam. Make sure you tell your doctor if you have any other medical problems.

Proper Use of samarium sm 153 lexidronam

Your doctor may have special instructions for you to follow to get ready for your treatment. If you do not understand them or if you have not received such instructions, check with your doctor in advance.

This radiopharmaceutical may accumulate in your bladder. Therefore, to increase the flow of urine and lessen the amount of radiation to your bladder your doctor may instruct you to drink plenty of liquids before receiving samarium Sm 153 lexidronam and urinate often afterwards.

If you have a problem controlling your bladder, tell your doctor before receiving samarium Sm 153 lexidronam. Special precautions will need to be taken to prevent radiation contamination of clothing, bed linens, and the environment.

Dosing

The dose of samarium sm 153 lexidronam 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 samarium sm 153 lexidronam. 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.

Precautions While Using samarium sm 153 lexidronam

It is very important that your doctor check your progress at regular visits to make sure that samarium sm 153 lexidronam is working properly and to check for unwanted effects. You may need to have blood tests done regularly.

Follow these guidelines for 12 hours after receiving samarium Sm 153 lexidronam, to help reduce the chance of contaminating other persons or the environment with radiation:

• Use a normal toilet, if available, instead of a urinal.


• Samarium Sm 153 lexidronam is passed mainly in the urine. To prevent contamination of your home environment, flush the toilet twice after using.


• Wipe any spilled urine with a tissue and flush it away.


• Wash your hands after using or cleaning the toilet.


• Wash your clothes and bed linens immediately, if they become soiled with your urine or blood. Wash them separately from other clothes.


• If you cut yourself, wash away any spilled blood.

Samarium Sm 153 lexidronam can temporarily lower the number of white blood cells in your blood, increasing the chance of getting an infection. It can also lower the number of platelets, which are necessary for proper blood clotting. If your blood count becomes abnormally low, there are certain precautions you can take to reduce the risk of infection or bleeding, such as:

• With abnormally low white blood cell counts:
  
  • If you can, avoid people with infections. Check with your doctor immediately if you think you are getting an infection or if you get a fever or chills, cough or hoarseness, lower back or side pain, or painful or difficult urination.
  
  
  • Be careful when using a regular toothbrush, dental floss, or toothpick. Your medical doctor, dentist, or nurse may recommend other ways to clean your teeth and gums. Check with your medical doctor before having any dental work done.
  
  
  • Do not touch your eyes or the inside of your nose unless you have just washed your hands and have not touched anything else in the meantime.
  
  


• With abnormally low platelet blood counts:
  
  • Check with your doctor immediately if you notice any unusual bleeding or bruising; black, tarry stools; blood in urine or stools; or pinpoint red spots on your skin.
  
  
  • Be careful not to cut yourself when you are using sharp objects such as a safety razor or fingernail or toenail cutters.
  
  
  • Avoid contact sports or other situations where bruising or injury could occur.
  
  

samarium sm 153 lexidronam Side Effects

Along with its needed effects, a medicine may cause some unwanted effects. Blood problems, such as a decrease in the number of white blood cells or platelets, may occur in some patients using samarium Sm 153 lexidronam.

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

More common

• Black, tarry stools


• blood in urine or stools


• cough or hoarseness


• fever or chills


• lower back or side pain


• painful or difficult urination


• pinpoint red spots on skin


• unusual bleeding or bruising

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

Less common

• Irregular heartbeat

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

• Increase in bone pain (transient)


• nausea and vomiting

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.

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Ambifed CD

Pronunciation: KOE-deen/gwye-FEN-e-sin/SOO-doe-e-FED-rin
Generic Name: Codeine/Guaifenesin/Pseudoephedrine
Brand Name: Examples include Ambifed CD and Maxifed-G CDX

Ambifed CD 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.

Ambifed CD is a decongestant, cough suppressant, and expectorant combination. The decongestant works by constricting blood vessels and reducing swelling in the nasal passages. The cough suppressant works in the brain to help decrease the cough reflex to reduce a dry cough. The expectorant loosens mucus and lung secretions in the chest and makes coughs more productive.

Do NOT use Ambifed CD if:

• you are allergic to any ingredient in Ambifed CD or any other codeine- or morphine-related medicine (eg, oxycodone)


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


• you are having an asthma attack


• you are taking sodium oxybate (GHB) or if you have taken furazolidone or a monoamine oxidase inhibitor (MAOI) (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 Ambifed CD:

Some medical conditions may interact with Ambifed CD. 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, dihydrocodeine, hydrocodone, 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; liver or kidney problems; blockage of the stomach, bowel, or bladder; adrenal gland problems; or thyroid problems


• if you have a history of constipation, stomach problems (eg, ulcers), bowel problems (eg, chronic inflammation or ulceration of the bowel), or gallbladder problems (eg, gallstones), or if you have had recent stomach, bowel, or urinary surgery


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


• if you have a fever, severe drowsiness, recent head or brain injury, brain tumor, increased pressure in the brain, infection of the brain or nervous system, or a seizure disorder (eg, epilepsy)


• if you have very poor health or a history of alcohol abuse, other substance abuse, or suicidal thoughts or actions


• if you are taking medicine for high blood pressure or depression

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

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


• Beta-blockers (eg, propranolol), catechol-O-methyltransferase (COMT) inhibitors (eg, tolcapone), cimetidine, furazolidone, HIV protease inhibitors (eg, ritonavir), indomethacin, MAOIs (eg, phenelzine ), or tricyclic antidepressants (eg, amitriptyline) because they may increase the risk of Ambifed CD's side effects


• Naltrexone, quinidine, or rifamycins (eg, rifampin) because they may decrease Ambifed CD's effectiveness


• Bromocriptine or sodium oxybate (GHB) because the risk of their side effects may be increased by Ambifed CD


• Guanadrel, guanethidine, mecamylamine, methyldopa, or reserpine because their effectiveness may be decreased by Ambifed CD

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

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

• Take Ambifed CD by mouth with or without food. If stomach upset occurs, take with food to reduce stomach irritation.


• Drink plenty of water while taking Ambifed CD.


• If you miss a dose of Ambifed CD, 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 Ambifed CD.

Important safety information:

• Ambifed CD may cause dizziness or drowsiness. These effects may be worse if you take it with alcohol or certain medicines. Use Ambifed CD with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.


• Do not drink alcohol or use medicines that may cause drowsiness (eg, sleep aids, muscle relaxers) while you are using Ambifed CD; it may add to their effects. Ask your pharmacist if you have questions about which medicines may cause drowsiness.


• Ambifed CD 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.


• Do not take diet or appetite control medicines while you are taking Ambifed CD without checking with your doctor.


• Ambifed CD 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 days, if they get worse, or if they go away and then come back, check with your doctor.


• If your symptoms occur along with fever, rash, or persistent headache, contact your doctor.


• Do not use Ambifed CD for a cough with a lot of mucus. Do not use it for a long-term cough (eg, caused by asthma, emphysema, smoking). However, you may use it for these conditions if your doctor tells you to.


• Ambifed CD may cause you to become sunburned more easily. Avoid the sun, sunlamps, or tanning booths until you know how you react to Ambifed CD. Use a sunscreen or wear protective clothing if you must be outside for more than a short time.


• Ambifed CD may interfere with certain lab tests. Be sure your doctor and lab personnel know you are taking Ambifed CD.


• Tell your doctor or dentist that you take Ambifed CD before you receive any medical or dental care, emergency care, or surgery.


• Use Ambifed CD with caution in the ELDERLY; they may be more sensitive to its effects, especially confusion, dizziness, drowsiness, dry mouth, excitability, low blood pressure, and trouble urinating.


• Caution is advised when using Ambifed CD in CHILDREN; they may be more sensitive to its effects, especially excitability.


• Ambifed CD should not be used in CHILDREN younger than 6 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 Ambifed CD while you are pregnant. Ambifed CD is found in breast milk. Do not breast-feed while taking Ambifed CD.

Possible side effects of Ambifed CD:

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; dizziness; drowsiness; excitability; headache; nausea; nervousness or anxiety; trouble sleeping; vomiting; 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); blurred vision or other vision changes; confusion; difficulty urinating; fainting; fast, slow, or irregular heartbeat; hallucinations; mental or mood changes; persistent trouble sleeping; seizures; severe dizziness, lightheadedness, or headache; severe drowsiness; shallow breathing; tremor; uncontrolled muscle movement.

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: Ambifed CD 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; shallow or rapid breathing; unusually fast, slow, or irregular heartbeat; vomiting.

Proper storage of Ambifed CD:

Store Ambifed CD 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 Ambifed CD out of the reach of children and away from pets.

General information:

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


• Ambifed CD 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 Ambifed CD. 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.

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Sitagliptin/Simvastatin

Pronunciation: SYE-ta-GLIP-tin /SIM-va-STAT-in
Generic Name: Sitagliptin/Simvastatin
Brand Name: Juvisync

Sitagliptin/Simvastatin is used for:

Treating type 2 diabetes and lowering high cholesterol and triglycerides in certain patients. It also increases high-density lipoprotein (HDL, "good") cholesterol levels. It is used along with diet and exercise. It is used in certain patients to reduce the risk of heart attack, stroke, and death due to coronary heart disease. It is also used to reduce the need for medical procedures to open blocked blood vessels. It may also be used for other conditions as determined by your doctor.

Sitagliptin/Simvastatin is a dipeptidyl peptidase-4 (DPP-4) inhibitor and HMG-CoA reductase inhibitor (statin) combination. The DPP-4 inhibitor works by increasing the amount of insulin released by your body and decreasing the amount of sugar made by your body. The statin works by reducing the production of certain fatty substances in the body, including cholesterol.

Do NOT use Sitagliptin/Simvastatin if:

• you are pregnant, may become pregnant, or are breast-feeding


• you are allergic to any ingredient in Sitagliptin/Simvastatin


• you have type 1 diabetes


• you have high blood or urine ketone levels (diabetic ketoacidosis)


• you have moderate or severe kidney problems


• you have liver problems or unexplained abnormal liver function tests


• you take cyclosporine, danazol, gemfibrozil, a hepatitis C virus (HCV) protease inhibitor (eg, boceprevir, telaprevir), an HIV protease inhibitor (eg, ritonavir), itraconazole, ketoconazole, certain macrolide antibiotics (eg, clarithromycin, erythromycin), mibefradil, nefazodone, posaconazole, or telithromycin


• you take or have taken conivaptan within the past 7 days

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

Before using Sitagliptin/Simvastatin:

Some medical conditions may interact with Sitagliptin/Simvastatin. 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 able to become pregnant


• 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 angioedema (swelling of the hands, face, lips, eyes, throat, or tongue; difficulty swallowing or breathing; or hoarseness) caused by another DPP-4 inhibitor (eg, saxagliptin)


• if you have low blood pressure, kidney problems, low thyroid function, muscle problems or a family history of muscle problems, or serious metabolism, hormonal, or electrolyte problems


• if you drink alcohol or have a history of seizures, liver problems, or alcohol abuse


• if you have a history of inflammation of the pancreas (pancreatitis) or stones in your gallbladder (gallstones)


• if you are scheduled for major surgery, have recently had major surgery or a serious injury, or if you have a serious infection


• if you have had an organ transplant and are taking medicine to suppress a rejection reaction

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

• Amiodarone, amlodipine, azole antifungals (eg, itraconazole, ketoconazole, posaconazole, voriconazole), colchicine, conivaptan, cyclosporine, danazol, daptomycin, delavirdine, diltiazem, dronedarone, fibrates (eg, gemfibrozil, clofibrate, fenofibrate), fusidic acid, HCV protease inhibitors (eg, boceprevir, telaprevir), HIV protease inhibitors (eg, ritonavir), imatinib, macrolide antibiotics (eg, clarithromycin, erythromycin), mibefradil, nefazodone, niacin, ranolazine, risperidone, streptogramins (eg, dalfopristin, quinupristin), telithromycin, or verapamil because they may increase the risk of muscle or kidney problems


• Rosiglitazone because the risk of swelling of the hands, legs, or feet may be increased


• Insulin or sulfonylureas (eg, glipizide) because the risk of low blood sugar may be increased


• Bosentan, carbamazepine, efavirenz, rifamycins (eg, rifampin), or St. John's wort because they may decrease Sitagliptin/Simvastatin's effectiveness


• Anticoagulants (eg, warfarin), digoxin, or macrolide immunosuppressants (eg, tacrolimus) because the risk of their side effects may be increased by Sitagliptin/Simvastatin

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

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

• Sitagliptin/Simvastatin comes with an extra patient information sheet called a Medication Guide. Read it carefully. Read it again each time you get Sitagliptin/Simvastatin refilled.


• Take Sitagliptin/Simvastatin by mouth with or without food in the evening, unless directed otherwise by your doctor.


• Swallow Sitagliptin/Simvastatin whole. Do not break, crush, or chew before swallowing.


• Eating grapefruit or drinking grapefruit juice may increase the amount of Sitagliptin/Simvastatin in your blood, which may increase your risk for serious side effects. The risk may be greater with large amounts of grapefruit or grapefruit juice. Avoid large amounts of grapefruit or grapefruit juice (eg, more than 1 quart daily). Talk with your doctor or pharmacist if you have questions about including grapefruit or grapefruit juice in your diet while you are taking Sitagliptin/Simvastatin.


• Take Sitagliptin/Simvastatin on a regular schedule to get the most benefit from it.


• Continue to take Sitagliptin/Simvastatin even if you feel well. Do not miss any doses.


• If you miss a dose of Sitagliptin/Simvastatin, 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 Sitagliptin/Simvastatin.

Important safety information:

• Sitagliptin/Simvastatin may cause liver problems. Rarely, severe and sometimes fatal liver failure has been reported in patients taking Sitagliptin/Simvastatin. Your risk of developing liver problems may be greater if you drink alcohol daily or in large amounts with Sitagliptin/Simvastatin, or if you have a history of liver problems. Check with your doctor before drinking alcohol while you are taking Sitagliptin/Simvastatin. Tell your doctor right away if you experience symptoms of liver problems (eg, yellowing of the skin or eyes; dark urine; pale stools; severe or persistent nausea, loss of appetite, or stomach pain; unusual tiredness).


• Carry an ID card at all times that says you have diabetes.


• Follow the diet and exercise program given to you by your health care provider. Proper diet, regular exercise, and regular blood sugar testing are important for best results with Sitagliptin/Simvastatin.


• Check your blood sugar levels as directed by your doctor. If they are often higher or lower than they should be and you take Sitagliptin/Simvastatin exactly as prescribed, tell your doctor.


• It may be harder to control your blood sugar during times of stress, such as fever, infection, injury, or surgery. Talk with your doctor about how to control your blood sugar if any of these occur. Do not change the dose of your medicine without checking with your doctor.


• Tell your doctor or dentist that you take Sitagliptin/Simvastatin before you receive any medical or dental care, emergency care, or surgery. Sitagliptin/Simvastatin may need to be stopped for a few days before certain types of surgery.


• Do NOT take more than the recommended dose without checking with your doctor.


• Muscle problems (myopathy) may occur with Sitagliptin/Simvastatin. The risk of muscle problems may be greater in people who take higher doses of Sitagliptin/Simvastatin, in people older than 64 years old, in women, or in people who have kidney problems or low thyroid function. It may also be greater in those who take it with certain other medicines (eg, niacin), especially in Chinese patients. Tell your doctor right away if you notice any unexplained muscle pain, tenderness, or weakness, especially if you also have a fever or general body discomfort.


• Sitagliptin/Simvastatin usually does not cause low blood sugar. However, low blood sugar may occur when it is used along with certain other medicines for diabetes (eg, insulin, sulfonylureas). Low blood sugar may make you anxious, sweaty, weak, dizzy, drowsy, or faint. It may also make your heart beat faster; make your vision change; give you a headache, chills, or tremors; or make you hungrier. It is a good idea to carry a reliable source of glucose (eg, tablets, gel) to treat low blood sugar. If this is not available, you should eat or drink a quick source of sugar like table sugar, honey, candy, orange juice, or non-diet soda. This will raise your blood sugar level quickly. Tell your doctor right away if this happens. To prevent low blood sugar, eat meals at the same time each day and do not skip meals.


• Severe and sometimes fatal inflammation of the pancreas has been reported in patients taking Sitagliptin/Simvastatin. Discuss any questions or concerns with your doctor. Contact your doctor immediately if you develop severe stomach or back pain with or without nausea or vomiting.


• Check blood sugar levels closely. Ask your doctor before you change the dose of your diabetes medicine.


• Rarely, changes to the skin, hair, and nails (eg, discoloration, dryness, hair loss) may occur. Check with your doctor if these effects become bothersome or cause you concern.


• Lab tests, including blood cholesterol levels, blood glucose, hemoglobin A_1c, liver and kidney function, and creatine phosphokinase (CPK) blood levels, may be performed while you use Sitagliptin/Simvastatin. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.


• Use Sitagliptin/Simvastatin with caution in the ELDERLY; they may be more sensitive to its effects, especially muscle problems.


• Sitagliptin/Simvastatin should be used with extreme caution in CHILDREN younger than 18 years old; safety and effectiveness in children have not been confirmed.


• Women who are able to become pregnant should use effective birth control while taking Sitagliptin/Simvastatin. Check with your doctor if you have questions about using birth control.


• PREGNANCY and BREAST-FEEDING: Do not use Sitagliptin/Simvastatin if you are pregnant. It may cause harm to the fetus. Avoid becoming pregnant while you are taking it. If you think you may be pregnant, contact your doctor right away. It is not known if Sitagliptin/Simvastatin is found in breast milk. Do not breast-feed while taking Sitagliptin/Simvastatin.

Possible side effects of Sitagliptin/Simvastatin:

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; headache; mild stomach pain; nausea; runny or stuffy nose; sore throat; upper respiratory tract infection.

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

Severe allergic reactions (rash; hives; itching; difficulty breathing or swallowing; tightness in the chest; swelling of the mouth, face, lips, throat, or tongue; unusual hoarseness); burning, numbness, or tingling; change in the amount of urine produced; dark or red-colored urine; decreased sexual ability; depression; dizziness; fast or irregular heartbeat; fever, chills, or persistent cough or sore throat; joint pain; memory problems; muscle pain, tenderness, or weakness (with or without fever and fatigue); red, swollen, blistered, or peeling skin; shortness of breath; swelling of the hands, legs, or feet; symptoms of liver problems (eg, dark urine, loss of appetite, pale stools, severe or persistent nausea or stomach pain, yellowing of the skin or eyes); symptoms of pancreas inflammation (eg, severe stomach or back pain with or without nausea or vomiting); trouble sleeping; unusual bruising or bleeding; unusual tiredness or weakness; vomiting.

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

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately.

Proper storage of Sitagliptin/Simvastatin:

Store Sitagliptin/Simvastatin at room temperature, between 68 and 77 degrees F (20 and 25 degrees C). Store away from heat, moisture, and light. Do not store in the bathroom. Keep Sitagliptin/Simvastatin out of the reach of children and away from pets.

General information:

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


• Sitagliptin/Simvastatin 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 Sitagliptin/Simvastatin. 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.

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• Sitagliptin/Simvastatin Dosage
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Zyclara

Generic Name: imiquimod topical (i MI kwi mod TOP ik al)

Brand Names: Aldara, Zyclara

What is imiquimod topical?

Imiquimod is an immune response modifier. Imiquimod topical is used to treat actinic keratosis (a condition caused by too much sun exposure) on the face and scalp.

Imiquimod topical (for the skin) is also used to treat a minor form of skin cancer called superficial basal cell carcinoma, when surgery would not be an appropriate treatment.

Imiquimod topical also treats genital warts that appear on the outside of the body, but this medicine is not a cure for genital warts. Imiquimod may be used in adults and children who are at least 12 years.

Imiquimod topical may also be used for purposes not listed in this medication guide.

What is the most important information I should know about imiquimod topical?

Using too much of this medicine, or using it for too long can increase your risk of severe skin reactions. Follow your doctor's instructions.

Do not use imiquimod topical on areas of broken, wounded, or burned skin. Wait until these conditions have healed before using imiquimod topical.

Before using this medication, tell your doctor if you have a weak immune system, an autoimmune disorder, graft-versus-host disease, or if you have recently received a bone marrow transplant or cord blood transplant.

When treating genital warts around the vagina, avoid getting the cream on the more sensitive inner layers of vaginal tissue. This could result in vaginal swelling or irritation and painful urination. Avoid exposure to sunlight or tanning beds. Imiquimod topical can make you sunburn more easily. Wear protective clothing and use sunscreen (SPF 30 or higher) when you are outdoors.

Imiquimod topical is not a cure for genital warts and it may not keep you from spreading this condition to others through vaginal, anal, or oral sex. You may develop new lesions during treatment with imiquimod topical. For best results, keep using the medicine for the entire length of time prescribed by your doctor.

Imiquimod will not protect against sexually transmitted diseases such as chlamydia, gonorrhea, herpes, HIV, syphilis, and trichomoniasis.

If you are treating the genital or rectal area with imiquimod topical, avoid sexual activity while the medicine is on your skin. Imiquimod topical can weaken the rubber that condoms or diaphragms are made out of. If you use a condom or diaphragm for birth control, these items could break if the rubber weakens and an unplanned pregnancy could result.

What should I discuss with my healthcare provider before using imiquimod topical?

To make sure you can safely take imiquimod topical, tell your doctor if you have any of these other conditions:

• 
  

  sunburn or other skin problems;

  
  


• 
  

  a weak immune system or autoimmune disorder;

  
  


• 
  

  graft-versus-host disease;

  
  


• 
  

  if you have recently been treated for actinic keratosis or genital warts with surgery or other medications; or

  
  


• 
  

  if you have recently received a bone marrow transplant or cord blood transplant.

  
  

FDA pregnancy category C. It is not known whether imiquimod topical will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant while using this medication. If you are treating the genital or rectal area with imiquimod topical, avoid sexual activity while the medicine is on your skin. Imiquimod topical can weaken the rubber that condoms or diaphragms are made out of. If you use a condom or diaphragm, these items could break if the rubber weakens, and an unplanned pregnancy could result. It is not known whether imiquimod topical passes into breast milk or if it could harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby. Do not use this medicine on a child younger than 12 years old. Imiquimod topical is for use in treating genital warts in patients who are at least 12 years old. All other uses of this medication are for adults over 18 only.

How should I apply imiquimod topical?

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

Using too much of this medicine, or using it for too long can increase your risk of severe skin reactions.

Before applying imiquimod topical, wash your hands and wash the skin area to be treated. Allow the skin to dry for at least 10 minutes before applying the medicine. Always wash your hands after applying the medicine also. Do not use imiquimod topical on areas of broken, wounded, or burned skin. Wait until these conditions have healed before using imiquimod topical.

Imiquimod topical is normally used 2 to 5 times per week for up to 16 weeks. How you use this medication will depend on the condition you are treating. Follow your doctor's instructions.

Actinic keratosis:

Aldara is usually applied 2 times per week (such as Monday and Thursday, or Tuesday and Friday) for a full 16 weeks. Zyclara is applied once daily for 2 weeks followed by 2 weeks without treatment. Apply the cream to the treatment area in a thin layer, and rub in the cream until it disappears. Use the medicine before going to bed and leave it on for 8 hours. In the morning, wash off the medicine with water and a mild soap.

Superficial basal cell carcinoma:

Usually applied 5 times per week (such as Monday through Friday) for a full 6 weeks. Apply the cream from one imiquimod topical packet to the treatment area and the border of skin around it, and rub in the cream until it disappears. Use the medicine before going to bed and leave it on for 8 hours. In the morning, wash off the medicine with water and a mild soap.

Genital warts:

Usually applied 3 times per week (such as Monday, Wednesday, and Friday) for no longer than 16 weeks. Apply the cream from one imiquimod topical packet to the treatment area, and rub in the cream until it disappears. Do not cover the treated skin areas with any type of plastic bandaging, and avoid nylon underwear. You may wear cotton gauze or underwear over the treated area. Use the medicine before going to bed and leave it on for 6 to 10 hours. Then wash off the medicine with water and a mild soap.

When treating genital warts under the foreskin of an uncircumcised penis, pull back the foreskin and wash it with mild soap and water before applying imiquimod topical. Clean this area daily during treatment. When treating genital warts around the vagina, avoid getting the cream on the more sensitive inner layers of vaginal tissue. This could result in vaginal swelling or irritation and painful urination.

Imiquimod topical is not a cure for genital warts and it may not keep you from spreading this condition to others through vaginal, anal, or oral sex. You may develop new lesions during treatment with imiquimod topical. For best results, keep using the medicine for the entire length of time prescribed by your doctor.

All conditions:

Your doctor will need to check your skin on a regular basis, especially if you have a more severe skin reaction to the medication. Do not miss any scheduled appointments.

Call your doctor if your skin condition does not improve or if it gets worse during treatment.

Do not use imiquimod topical to treat any skin condition that has not been checked by a doctor. Do not share this medication with anyone else, even if they have the same symptoms you have.

Each packet of imiquimod topical is for a single application only. Throw away the packet after one use, even if there is medicine left in it. If you treat more than one skin area at a time, ask your doctor how many packets to use.

Store at room temperature away from moisture and heat. Do not freeze. Keep each packet unopened until you are ready to use it.

What happens if I miss a dose?

Skip the missed dose and wait until the next time you are getting ready for bed to use the medicine. Do not use extra medicine to make up the missed dose.

What happens if I overdose?

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

Overdose symptoms may include severe skin irritation, feeling light-headed, or fainting.

What should I avoid while using imiquimod topical?

Avoid getting this medication in your eyes, mouth, and nose, or on your lips. Do not place the cream in your rectum, vagina, or urethra. If it does get into any of these areas, rinse with water. Do not use imiquimod topical on sunburned, windburned, dry, chapped, irritated, or broken skin.

Avoid using other medications on the areas you treat with imiquimod topical unless you doctor tells you to.

Avoid exposure to sunlight or tanning beds. Imiquimod topical can make you sunburn more easily. Wear protective clothing and use sunscreen (SPF 30 or higher) when you are outdoors.

Avoid having unprotected sex. Imiquimod is not a cure for genital warts, and it will not protect against sexually transmitted diseases such as chlamydia, gonorrhea, herpes, HIV, syphilis, and trichomoniasis. Talk with your doctor about safe ways to prevent transmission during sex.

Imiquimod topical side effects

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat. Wash off the medicine and call your doctor at once if you have a serious skin reaction such as severe itching, burning, oozing, bleeding, or skin changes where the medicine is applied. Stop using imiquimod topical and call your doctor at once if you have a serious side effect such as flu symptoms such as fever, chills, body aches, tired feeling, swollen glands. When treating genital warts around the vagina, if you have severe swelling or urination problems, stop using imiquimod topical and call your doctor right away.

Less serious side effects may include:

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  mild skin irritation, itching, dryness, flaking, scabbing, crusting, redness, or hardening of the skin where the medicine was applied;

  
  


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  changes in the color of treated skin;

  
  


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  headache, dizziness, chest pain, back pain;

  
  


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  cold sores, fever blisters;

  
  


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  cold symptoms such as stuffy nose, sneezing, sore throat;

  
  


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  nausea, diarrhea, loss of appetite; or

  
  


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  vaginal itching or discharge.

  
  

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 imiquimod topical?

It is not likely that other drugs you take orally or inject will have an effect on topically applied imiquimod topical. But many drugs can interact with each other. Tell your doctor about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal products. Do not start a new medication without telling your doctor.

More Zyclara resources

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

• Zyclara Prescribing Information (FDA)


• Zyclara Topical Advanced Consumer (Micromedex) - Includes Dosage Information


• Zyclara Cream MedFacts Consumer Leaflet (Wolters Kluwer)


• Zyclara Consumer Overview


• Aldara Prescribing Information (FDA)


• Aldara Monograph (AHFS DI)


• Aldara MedFacts Consumer Leaflet (Wolters Kluwer)


• Aldara Consumer Overview

Compare Zyclara with other medications

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Where can I get more information?

• Your pharmacist can provide more information about imiquimod topical.

See also: Zyclara side effects (in more detail)