Aptivus 100 mg / ml oral solution

Aptivus 100 mg/ml oral solution

Tipranavir

Read all of this leaflet carefully before your child starts taking this medicine.

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


• If you have any further questions, please ask your child’s doctor or pharmacist.


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


• If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your child’s doctor or pharmacist.

In this leaflet:

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


• 2. Before your child takes APTIVUS


• 3. How to take APTIVUS


• 4. Possible side effects


• 5. How to store APTIVUS


• 6. Further information

What Aptivus Is And What It Is Used For

APTIVUS belongs to a group of medicines called protease inhibitors and is used in the treatment of Human Immunodeficiency Virus (HIV) infection. APTIVUS is an inhibitor of the HIV protease enzyme which the HIV needs to multiply. By inhibiting the protease enzyme APTIVUS helps control HIV infection. Your child must take APTIVUS together with:

• low dose ritonavir (this helps APTIVUS to reach a high enough level in your child’s blood)


• other HIV medicines. Your child’s doctor will decide which other medicines they should take. This will depend on, for example:
  
  
  • which other medicines your child has already taken for HIV
  • which medicines your child’s HIV is resistant to. If your child’s HIV is resistant to some HIV medicines, this means that the medicine will not work so well.

APTIVUS is specifically used for the treatment of HIV which is resistant to most other protease inhibitors. Before starting treatment, your child’s doctor will have taken blood samples to test the resistance of your child’s HIV. These tests will have confirmed that the HIV in your child’s blood is resistant to most other protease inhibitors. APTIVUS treatment is therefore appropriate for your child. Your child should not use APTIVUS if they have never received antiretroviral therapy or have other antiretroviral options available.

APTIVUS oral solution is indicated for:

• children from 2 to 12 years of age

Before Your Child Takes Aptivus

Your child must take APTIVUS in combination with low dose ritonavir and other antiretroviral medicines. It is therefore important that you know about these medicines too. You should therefore carefully read the Package Leaflets of ritonavir and your child’s other antiretroviral medicines. If you have any further questions about ritonavir or the other medicines your child is prescribed, please ask your child’s doctor or pharmacist.

Do NOT give APTIVUS

• if your child is allergic (hypersensitive) to tipranavir


• if your child is allergic (hypersensitive) to any of the other ingredients of APTIVUS. See Section 6 for a list of other ingredients


• if your child has moderate to severe liver problems. Your child’s doctor will take a blood sample to test how well your child’s liver is working (your child’s liver function). Depending on your child’s liver function they may have to delay or stop APTIVUS treatment


• if your child is currently taking products containing:
  
  
  • rifampicin (used to treat tuberculosis)
  • cisapride (used to treat stomach problems)
  • pimozide or sertindole (used to treat schizophrenia)
  • triazolam or oral midazolam (taken by mouth). These medicines are used to treat anxiety or sleep disorders
  • ergot derivatives (used to treat headaches)
  • astemizole or terfenadine (used to treat allergies or hay fever)
  • simvastatin or lovastatin (used to lower blood cholesterol)
  • amiodarone, bepridil, flecainide, propafenone or quinidine (used to treat heart disorders)
  • metoprolol (used to treat heart failure)

Your child must not take products containing St John’s wort (a herbal remedy for depression). This may stop APTIVUS from working properly.

Take special care with APTIVUS

Tell your child’s doctor if they have:

• type A or B haemophilia


• diabetes


• liver disease.

If your child has:

• high liver function tests results


• hepatitis B or C infection

your child is at increased risk of severe and potentially fatal liver damage while taking antiretroviral therapy in general, including APTIVUS. Your child’s doctor will monitor their liver function by blood tests before and during APTIVUS treatment. If your child has liver disease or hepatitis, their doctor will decide if they need additional testing. You should inform your child’s doctor as soon as possible if you notice your child has the signs or symptoms of hepatitis:

• fever


• malaise (feeling generally unwell)


• nausea (feeling sick)


• vomiting


• abdominal pain


• tiredness


• jaundice (yellowing of the skin or the eyeballs)

APTIVUS is not a cure for HIV infection:

You should know that your child may continue to develop infections and other illnesses associated with HIV disease. You should therefore remain in regular contact with your child’s doctor. In addition, APTIVUS does not prevent the risk of passing on HIV to others through blood or sexual contact. Your child should therefore continue to use appropriate precautions to prevent HIV transmission. For example your child should use a condom and your child should not breast-feed or donate blood.

Rash:

Mild to moderate rash, including:

• hives


• rash with flat or raised small red spots


• sensitivity to the sun

have been reported in approximately 1 in 10 patients receiving APTIVUS. Some patients who developed rash also had:

• joint pain or stiffness


• throat tightness


• generalized itching

Redistribution, accumulation or loss of body fat may occur in patients receiving combination antiretroviral therapy. Contact your child’s doctor if you notice changes in body fat.

Your child’s doctor may decide to monitor their levels of blood lipids (fats) before and during APTIVUS treatment.

In some patients with advanced HIV infection (AIDS) and a history of opportunistic infection, signs and symptoms of inflammation from previous infections may occur soon after anti-HIV treatment is started. It is believed that these symptoms are due to an improvement in the body’s immune response, enabling the body to fight infections that may have been present with no obvious symptoms. If you notice any symptoms of infection, please inform your child’s doctor immediately.

Bone problems: Some patients taking combination antiretroviral therapy may develop a bone disease called osteonecrosis (death of bone tissue caused by loss of blood supply to the bone). The length of combination antiretroviral therapy, corticosteroid use, alcohol consumption, severe immunosuppression, higher body mass index, among others, may be some of the many risk factors for developing this disease. Signs of osteonecrosis are joint stiffness, aches and pains (especially of the hip, knee and shoulder) and difficulty in movement. If you notice any of these symptoms please inform your child’s doctor.

Children:

APTIVUS should neither be used by children under 2 years of age nor by adolescents 12 years of age or older.

APTIVUS oral solution contains vitamin E. Your child should not take any additional vitamin E supplements.

Taking other medicines

Please tell your child’s doctor or pharmacist if they are taking or have recently taken any other medicines, including medicines obtained without a prescription.

This is very important. If your child takes other medicines at the same time as APTIVUS and ritonavir, this can strengthen or weaken the effect of the medicines. These effects are called interactions, and can lead to serious side effects, or prevent proper control of other conditions your child may have.

Interactions with other HIV medicines:

• Abacavir and zidovudine. These belong to a class of HIV medicines called nucleoside reverse transcriptase inhibitors (NRTIs). Your child’s doctor will only prescribe them abacavir and zidovudine if they are unable to take other NRTIs. Otherwise, your child can take APTIVUS, together with ritonavir, with HIV reverse transcriptase inhibitors including:
  
  
  • stavudine
  • lamivudine
  • tenofovir
  • didanosine: If your child is taking didanosine enteric coated tablets, they should take them at least two hours before or after APTIVUS.
    
    


• Protease Inhibitors (PIs): Taking APTIVUS may cause large decreases in the blood levels of other HIV protease inhibitors. For example the protease inhibitors amprenavir, atazanavir, lopinavir and saquinavir will be decreased.

Taking APTIVUS, with atazanavir, may cause the blood levels of APTIVUS and ritonavir to increase a lot.

Your child’s doctor will carefully consider whether to treat them with combinations of APTIVUS and these protease inhibitors.

Other medicines with which APTIVUS may interact include:

• oral contraceptives/hormone replacement therapy (HRT):
  
  If your child is taking the contraceptive pill to prevent pregnancy they should use an additional or different type of contraception (e.g. barrier contraception like condoms). Generally, it is not recommended to take APTIVUS, with ritonavir, together with oral contraceptives or hormone replacement therapy (HRT). You should check with your child’s doctor if they do wish to continue taking oral contraceptives or HRT. If your child uses oral contraceptives or HRT they have an increased chance of developing a skin rash while taking APTIVUS. If a rash occurs, it is usually mild to moderate. You should talk to your child’s doctor as they may need to temporarily stop taking either APTIVUS or their oral contraceptives or HRT


• carbamazepine, phenobarbital and phenytoin (used to treat epilepsy). These may decrease the effectiveness of APTIVUS.


• sildenafil, vardenafil, tadalafil (medicines used to produce and maintain an erection). The effects of sildenafil and vardenafil are likely to be increased if taken with APTIVUS. Tadalafil should not be prescribed until APTIVUS has been taken for 7 days or more.


• omeprazole, esomeprazole, lansoprazole, pantoprazole, rabeprazole (proton pump inhibitors used to reduce the gastric acid production)


• metronidazole (used to treat infections)


• disulfiram (used to treat alcohol dependence)

The following medications are not recommended:

• fluticasone (used to treat asthma)


• atorvastatin (used to lower blood cholesterol).

APTIVUS may lead to a loss of effectiveness of some medicines including:

• methadone, meperidine (pethidine), used as morphine substitutes

Your child’s doctor may have to increase or decrease the dose of other medicines which they take together with APTIVUS.

Examples include:

• rifabutin and clarithromycin (antibiotics)


• theophylline (used to treat asthma)


• desipramine, trazodone and bupropion (used to treat depression; bupropion is also used for smoking cessation)


• midazolam (when given by injection); midazolam is a sedative used to treat anxiety and to help your child sleep.

Tell your child’s doctor if they receive medication such as antiplatelet agents and anticoagulants, or if they are taking vitamin E. Your child’s doctor may wish to consider certain precautionary measures in such circumstances.

Pregnancy and breast-feeding

Tell your child’s doctor if they are pregnant or planning to become pregnant. If your child is pregnant they should only take APTIVUS after careful discussion with their doctor. It is not known whether APTIVUS may be used safely during pregnancy. See also Section 2, under “Oral contraceptives/ hormone replacement therapy (HRT)”.

Make sure you tell your child’s doctor if they are breast-feeding. Your child must not breast-feed their baby because it is possible that the baby can become HIV-infected through the breast milk.

Ask your child’s doctor or pharmacist for advice before they take any medicine.

Driving and using machines

Some of the side effects of APTIVUS may affect your child’s ability to drive or operate machinery (e.g. dizziness and sleepiness). If affected, your child should not drive or operate machinery.

How To Take Aptivus

Your child must always take APTIVUS exactly as their doctor has told them. You should check with your child’s doctor or pharmacist if you are not sure. Your child must take APTIVUS together with ritonavir.

APTIVUS oral solution should be taken with food.

The dose for children, age 2 to 12 years, will be calculated by the doctor. This will be based on the child’s body surface area in metres squared. The dose for children should not exceed 5 ml (500 mg) twice a day. Be sure your child’s doctor clearly informs you what the correct dose for your child should be. You should measure the exact dose using the supplied measuring syringe and adapter, as follows:

• 1. Check that the oral solution is clear (see below).


• 2. Open the bottle by pressing down on the cap and turning it in an anti-clockwise direction.


• 3. Remove the syringe cap covering the tip of the syringe (the cap will not be attached if this is the first time you are using the syringe).


• 4. Insert the syringe into the adapter located in the neck of the bottle. Make sure the syringe is tightly inserted. The maximum volume you can withdraw at one time is 5ml (equivalent to 500mg tipranavir), which is the maximum single dose for a child with a Body Surface Area of greater than 1.33 square metres.


• 5. Turn the bottle upside down and gently withdraw the required amount of APTIVUS oral solution.


• 6. Gently empty APTIVUS oral solution from the syringe into your child’s mouth.


• 7. After use of the syringe, replace the syringe cap.

Before giving APTIVUS you should check that the oral solution is clear. Crystals may be seen as a paper-thin layer at the bottom of the bottle when it is stored upright. There may be other particles at the bottom of the bottle.

A small amount of crystals does not affect the strength or safety of your child’s medicine.

You should return the bottle to your child’s pharmacist or doctor for a replacement as soon as possible if:

• there is more than a thin layer of crystals at the bottom of the bottle, or


• you are uncertain about the amount of crystals you see or


• any other particles are visible.

Until you exchange the bottle, please continue to give your child their usual doses of APTIVUS oral solution.

Your child will always have to take APTIVUS in combination with other antiretroviral medicines. You should follow the instructions for these medicines within the supplied Package Leaflets.

Your child should continue to take APTIVUS for as long as your child’s doctor tells them. At the age of 12 years, children treated with APTIVUS should be switched from the oral solution to the capsules.

If your child takes more APTIVUS than they should

Inform your child’s doctor as soon as possible if they take more than the prescribed dose of APTIVUS.

If your child forgets to take APTIVUS

If your child misses a dose of APTIVUS or ritonavir by more than 5 hours, wait and then give the next dose of APTIVUS and ritonavir at the regularly scheduled time. If your child misses a dose of APTIVUS and/or ritonavir by less than 5 hours, give the missed dose immediately. Then give the next dose of APTIVUS and ritonavir at the regularly scheduled time.

If your child stops taking APTIVUS

It has been shown that taking all doses at the appropriate times:

• greatly increases the effectiveness of your child’s combination antiretroviral medicines


• reduces the chances of your child’s HIV becoming resistant to their antiretroviral medicines.

Therefore, it is important that your child continues taking APTIVUS correctly, as described above. Your child must NOT stop taking APTIVUS unless their doctor instructs them to do so.

If you have any further questions on the use of this product, ask your child’s doctor or pharmacist.

Possible Side Effects

Like all medicines, APTIVUS can cause side effects, although not everybody gets them. It may be difficult to tell the difference between:

• side effects caused by APTIVUS


• side effects caused by the other medicines your child is also taking


• complications of HIV infection.

For this reason it is very important that you tell your child’s doctor about any changes in their health.

Important side effects associated with Aptivus:

• Abnormal liver function
  
  
  • Hepatitis and fatty liver (which can occur in less than 1 in a 100 patients treated)
  • Liver failure (which can occur in less than 1 in a 1,000 patients treated). This can lead to death
  • Increased blood levels of bilirubin (a breakdown product of haemoglobin)

You should inform your child’s doctor if they experience:

• Loss of appetite


• Nausea (feeling sick)


• Vomiting and/or jaundice

which may be symptoms of abnormal liver function

• Bleeding
  
  • Bleeding in the brain. This can lead to permanent disability or death, and has occurred in some patients treated with APTIVUS in clinical trials. In the majority of these patients the bleeding may have had other causes. For example they had other medical conditions or were receiving other medicine that may have caused the bleeding.

Possible side effects:

The frequency of possible side effects listed below is defined using the following convention:

• very common (affects more than 1 user in 10)


• common (affects 1 to 10 users in 100)


• uncommon (affects 1 to 10 users in 1,000)


• rare (affects 1 to 10 users in 10,000)


• very rare (affects less than 1 user in 10,000)


• not known (frequency cannot be estimated from the available data).

Adults

Very common

• Diarrhoea


• Nausea (feeling sick)


• Increases in blood lipid (fat) levels

Common

• Vomiting


• Abdominal pain (tummy pain)


• Flatulence (breaking wind more often)


• Tiredness


• Headache


• Mild rashes e.g. with hives or with flat or raised small red spots


• Increases in liver enzyme activity.

Uncommon

• Reduction in red and white blood cells


• Reduction in blood platelets


• Allergic (hypersensitivity) reactions


• Decreased appetite


• Diabetes


• Increased blood levels of:
  
  
  • the pancreas enzymes amylase and lipase
  • cholesterol


• Sleeplessness and other sleep disorders (including sleepiness)


• Dizziness


• Numbness and/or tingling and/or pain in the feet or hands


• Breathing difficulties


• Heartburn


• Inflammation of the pancreas


• Skin inflammation


• Loss or gain of body fat and other changes in fat distribution (see below)


• Muscle cramp


• Muscle pain


• Kidney disease


• Flu like symptoms (feeling unwell with fever)


• Weight loss.

Rare

• Dehydration (when the body does not have enough water)


• Thinning of the face


• Increased blood sugar.

Further information on possible side effects related to combination antiretroviral treatment:

• Blood
  
  Combination antiretroviral therapy may also cause:
  
  
  • Raised lactic acid in the blood.
  • Raised sugar in the blood. The effect of insulin (used to treat diabetics to reduce blood sugar) may be reduced.
  • Hypertriglyceridaemia (increased triglycerides (fats) in the blood)
  • Hypercholesterolaemia (increased cholesterol in the blood)


• Bleeding
  
  
  • Increased bleeding. If your child has haemophilia type A and B, they may experience increased bleeding. This may be in the skin or joints. If your child suffers increased bleeding you should see your child’s doctor immediately.

Combination antiretroviral therapy may cause changes in body shape due to changes in fat distribution. These may include loss of fat from legs, arms and face, increased fat in the abdomen (belly) and other internal organs, breast enlargement and fatty lumps on the back of the neck (‘buffalo hump’). The cause and long-term health effects of these conditions are not known at this time.

Muscle disorders

There have been reports of muscle pain, tenderness or weakness. These occur particularly when APTIVUS or other protease inhibitors are taken together with nucleoside analogues. Rarely these muscle disorders have been serious, involving breakdown of muscle tissue (rhabdomyolysis).

Children

The most common side effects were generally similar to those described in adults. Vomiting, rash and fever were observed more frequently in children than in adults.

If any of the side effects gets serious, or if you notice any side effects not mentioned in this leaflet, please tell your child’s doctor or pharmacist.

How To Store Aptivus

Keep out of the reach and sight of children.

Do not use APTIVUS after the expiry date which is stated on the bottle after EXP. The expiry date refers to the last day of that month.

Do not store below 15°C. Do not refrigerate or freeze. Once the bottle is opened your child should use the medicine within 60 days. You should write the date of opening the bottle on the label and/or outer carton. Keep the container in the outer carton.

If you notice more than a thin layer of crystals at the bottom of the bottle you should:

• give the next dose


• return the bottle to the pharmacist or doctor as soon as possible for a fresh supply.

Medicines should not be disposed of via wastewater or household waste. Ask your child’s pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

Further Information

What APTIVUS contains

• The active substance is tipranavir. Each ml contains 100 mg tipranavir.


• The other ingredients are macrogol, vitamin E polyethylene glycol succinate, purified water, propylene glycol, mono/ diglycerides of caprylic/capric acid, sucralose, ascorbic acid, Butter Mint and Butter Toffee flavourings.

What APTIVUS looks like and contents of the pack

APTIVUS oral solution is a clear yellow liquid.

APTIVUS oral solution is supplied in amber glass bottles containing 95 ml of oral solution. A 5 ml syringe and adapter is supplied for dosing.

APTIVUS is also available as soft capsules.

Marketing Authorisation Holder

Boehringer Ingelheim International GmbH

Binger Strasse 173

D-55216 Ingelheim am Rhein

Germany

Manufacturer

Boehringer Ingelheim Pharma GmbH & Co. KG

Binger Strasse 173

D-55216 Ingelheim am Rhein

Germany

For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:

This leaflet was last approved in 11/2009

Detailed information on this medicine is available on the European Medicines Agency (EMEA) web site: http://www.emea.europa.eu.

72941-02

Cortisporin Ointment

Pronunciation: BAS-i-TRAY-sin/HYE-droe-KOR-ti-sone/NEE-oh-MYE-sin/POL-ee-MIX-in
Generic Name: Bacitracin/Hydrocortisone/Neomycin/Polymyxin
Brand Name: Cortisporin

Cortisporin Ointment is used for:

Treating steroid-sensitive skin disorders that have a secondary infection caused by bacteria.

Cortisporin Ointment is a combination of 3 antibiotics and a corticosteroid. The antibiotics kill the bacteria and hydrocortisone reduces inflammation.

Do NOT use Cortisporin Ointment if:

• you are allergic to any ingredient in Cortisporin Ointment


• you have a fungal (eg, ringworm), viral (eg, herpes simplex, chickenpox), or tuberculosis (TB) infection of the skin

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

Before using Cortisporin Ointment:

Some medical conditions may interact with Cortisporin Ointment. 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 recently received or will be receiving a vaccine, or you have had a positive TB skin test


• if you have thinning of the skin

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

Ask your health care provider if Cortisporin Ointment 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 Cortisporin Ointment:

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

• Cortisporin Ointment is for external use only. Avoid contact with the eyes.


• Before using Cortisporin Ointment, clean the affected area. Apply a small amount of Cortisporin Ointment (an amount equal to the surface of the tip of a finger) on the area as directed. The treated area may be covered with a clean bandage.


• To clear up your infection completely, use Cortisporin Ointment for the full course of treatment. Keep using it even if you feel better in a few days.


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

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

Important safety information:

• Cortisporin Ointment only works against bacteria; it does not treat viral infections (eg, the common cold).


• Be sure to use Cortisporin Ointment for the full course of treatment. If you do not, the medicine may not clear up your infection completely. The bacteria could also become less sensitive to this or other medicines. This could make the infection harder to treat in the future.


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


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


• Long-term or repeated use of Cortisporin Ointment may cause a second infection. Tell your doctor if signs of a second infection occur. Your medicine may need to be changed to treat this.


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


• Corticosteroids may affect growth rate in CHILDREN and teenagers in some cases. They may need regular growth checks while they use Cortisporin Ointment.


• PREGNANCY and BREAST-FEEDING: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Cortisporin Ointment while you are pregnant. It is not known if Cortisporin Ointment is found in breast milk. If you are or will be breast-feeding while you are using Cortisporin Ointment, check with your doctor or pharmacist to discuss the risks to your baby.

Possible side effects of Cortisporin Ointment:

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

Burning, dryness, or itching of skin; worsening of condition.

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); hearing or kidney problems; second infection.

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: Cortisporin side effects (in more detail)

If OVERDOSE is suspected:

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

Proper storage of Cortisporin Ointment:

Store Cortisporin Ointment at room temperature, between 59 and 77 degrees F (15 and 25 degrees C). Store away from heat, moisture, and light. Keep Cortisporin Ointment out of the reach of children and away from pets.

General information:

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


• Cortisporin Ointment 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 Cortisporin Ointment. 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 Cortisporin resources

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

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• Bacterial Skin Infection
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Tenuate Dospan

Generic Name: diethylpropion (dye eth ill PROE pee on)

Brand Names: Tenuate

What is Tenuate Dospan (diethylpropion)?

Diethylpropion is an appetite suppressant similar to an amphetamine. Diethylpropion stimulates your central nervous system (nerves and brain), which increases your heart rate and blood pressure and decreases your appetite.

Diethylpropion is used as together with diet and exercise to treat of obesity.

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

What is the most important information I should know about Tenuate Dospan (diethylpropion)?

Taking diethylpropion in combination with other diet pills or appetite suppressants can cause serious or life threatening medical problems. Do not use any other diet medications while taking diethylpropion, unless your doctor tells you to. You should not take this medication if you are allergic to diethylpropion or if you have pulmonary hypertension, severe coronary artery disease, glaucoma, overactive thyroid, uncontrolled high blood pressure, a history of drug or alcohol addiction, if you are agitated, or if you are taking any other diet pills. Do not use diethylpropion if you have used an MAO inhibitor such as furazolidone (Furoxone), isocarboxazid (Marplan), phenelzine (Nardil), rasagiline (Azilect), selegiline (Eldepryl, Emsam, Zelapar), or tranylcypromine (Parnate) in the last 14 days. A dangerous drug interaction could occur, leading to serious side effects.

Before you take diethylpropion, tell your doctor if you have a heart murmur, heart valve disorder, heart rhythm disorder, epilepsy, or if you have taken other diet pills within the past 12 months.

This medication may cause blurred vision and may impair your thinking or reactions. Diethylpropion may also cause restless feelings that can hide the symptoms of extreme tiredness. Be careful if you drive or do anything that requires you to be alert and able to see clearly. Diethylpropion may be habit-forming and should be used only by the person it was prescribed for. Keep the medication in a secure place where others cannot get to it. Do not stop using diethylpropion suddenly after long-term use, or you could have unpleasant withdrawal symptoms. Ask your doctor how to avoid withdrawal symptoms when you stop using diethylpropion.

What should I discuss with my healthcare provider before taking Tenuate Dospan (diethylpropion)?

Taking diethylpropion in combination with other diet pills or appetite suppressants can cause serious or life threatening medical problems. Do not use any other diet medications while taking diethylpropion, unless your doctor tells you to. You should not take this medication if you are allergic to diethylpropion or similar medicines (stimulants, diet pills, cold or allergy medicines), or if you have:

• 
  

  pulmonary hypertension;

  
  


• 
  

  severe coronary artery disease (hardened arteries);

  
  


• 
  

  glaucoma;

  
  


• 
  

  overactive thyroid;

  
  


• 
  

  severe or uncontrolled high blood pressure;

  
  


• 
  

  a history of drug or alcohol addiction;

  
  


• 
  

  if you are in an agitated state; or

  
  


• 
  

  if you are taking any other appetite suppressants or diet pills.

  
  

Do not use diethylpropion if you have used an MAO inhibitor such as furazolidone (Furoxone), isocarboxazid (Marplan), phenelzine (Nardil), rasagiline (Azilect), selegiline (Eldepryl, Emsam, Zelapar), or tranylcypromine (Parnate) in the last 14 days. A dangerous drug interaction could occur, leading to serious side effects.

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

• 
  

  a heart murmur, heart valve disorder, or heart rhythm disorder;

  
  


• 
  

  epilepsy or other seizure disorder; or

  
  


• 
  

  if you have taken other diet pills within the past 12 months.

  
  

Diethylpropion may be habit forming and should be used only by the person it was prescribed for. Never share diethylpropion with another person, especially someone with a history of drug abuse or addiction. Keep the medication in a place where others cannot get to it. FDA pregnancy category B. Diethylpropion is not expected to harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant during treatment. Diethylpropion 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. Do not give this medicine to a child younger than 16 years old.

How should I take Tenuate Dospan (diethylpropion)?

Take exactly as prescribed. Never take diethylpropion in larger amounts, or for longer than recommended by your doctor. Follow the directions on your prescription label. Tell your doctor if the medicine seems to stop working as well in relieving your hunger.

Tell your doctor if you do not lose at least 4 pounds after taking the medication for 4 weeks along with a low calorie diet.

Diethylpropion is usually taken once a day in the midmorning.

Do not crush, chew, or break a controlled release tablet. Swallow it whole. Breaking or opening the pill may cause too much of the drug to be released at one time. Store at room temperature away from moisture and heat.

Keep track of the amount of medicine used from each new bottle. Diethylpropion is a drug of abuse and you should be aware if anyone is using your medicine improperly or without a prescription.

What happens if I miss a dose?

Take the missed dose as soon as you remember. Skip the missed dose if it is already evening. Wait until the next morning to take your next scheduled dose. Do not take 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 forms of some of the side effects listed in this medication guide.

What should I avoid while taking Tenuate Dospan (diethylpropion)?

This medication may cause blurred vision and may impair your thinking or reactions. Diethylpropion may also cause restless feelings that can hide the symptoms of extreme tiredness. Be careful if you drive or do anything that requires you to be alert and able to see clearly. Drinking alcohol can increase certain side effects of diethylpropion.

Tenuate Dospan (diethylpropion) 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. Stop using diethylpropion and call your doctor at once if you have a serious side effect such as:

• 
  

  fast, pounding, or uneven heartbeats;

  
  


• 
  

  chest pain, feeling short of breath (even with mild exertion);

  
  


• 
  

  feeling like you might pass out;

  
  


• 
  

  swelling in your ankles or feet;

  
  


• 
  

  confusion, hallucinations, unusual thoughts or behavior;

  
  


• 
  

  seizure (convulsions);

  
  


• 
  

  muscle movements you cannot control; or

  
  


• 
  

  sudden numbness or weakness, especially on one side of the body.

  
  

Less serious side effects may include:

• 
  

  nausea, vomiting, diarrhea, upset stomach;

  
  


• 
  

  headache, blurred vision;

  
  


• 
  

  feeling nervous, anxious, or jittery;

  
  


• 
  

  sleep problems (insomnia);

  
  


• 
  

  dizziness, drowsiness, tired feeling;

  
  


• 
  

  depressed mood;

  
  


• 
  

  dry mouth, unpleasant taste in your mouth;

  
  


• 
  

  decreased sex drive; or

  
  


• 
  

  mild itching or rash.

  
  

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 Tenuate Dospan (diethylpropion)?

Tell your doctor about all other medicines you use, especially:

• 
  

  insulin or oral diabetes medication;

  
  


• 
  

  blood pressure medication; or

  
  


• 
  

  stimulants, cold or allergy medicines, ADHD (attention deficit hyperactivity disorder) medicine such as Adderall or Ritalin.

  
  

This list is not complete and other drugs may interact with diethylpropion. 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 Tenuate Dospan resources

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

• Tenuate Dospan Advanced Consumer (Micromedex) - Includes Dosage Information


• Tenuate Dospan Controlled-Release Tablets MedFacts Consumer Leaflet (Wolters Kluwer)


• Diethylpropion Prescribing Information (FDA)


• Diethylpropion MedFacts Consumer Leaflet (Wolters Kluwer)


• Diethylpropion Hydrochloride Monograph (AHFS DI)


• Tenuate Consumer Overview

Compare Tenuate Dospan with other medications

• Obesity

Where can I get more information?

• Your pharmacist can provide more information about diethylpropion.

See also: Tenuate Dospan side effects (in more detail)

nelarabine

Generic Name: nelarabine (nel AR a been)

Brand Names: Arranon

What is nelarabine?

Nelarabine interferes with the growth of cancer cells and slows their growth and spread in the body.

Nelarabine is used to treat T-cell acute lymphoblastic leukemia and T-cell lymphoblastic lymphoma.

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

What is the most important information I should know about nelarabine?

Nelarabine may cause serious side effects of the central nervous system, such as problems with balance, coordination, or fine motor skills. These symptoms may not go away even after you stop receiving nelarabine. Talk with your doctor if you have concerns about any possible long-term side effects.

Do not use nelarabine if you are pregnant. It could harm the unborn baby.

Before you receive nelarabine, tell your doctor if you have liver or kidney disease, a nerve disorder, a history of chemotherapy or radiation treatment of your head, neck, or spinal cord.

Nelarabine can lower blood cells that help your body fight infections. This can make it easier for you to bleed from an injury or get sick from being around others who are ill. Your blood will need to be tested often. Visit your doctor regularly.

Do not receive a "live" vaccine while you are being treated with nelarabine, and avoid coming into contact with anyone who has recently received a live vaccine. There is a chance that the virus could be passed on to you. Nelarabine may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be awake and alert.

What should I discuss with my healthcare provider before receiving nelarabine?

Do not receive this medication if you are allergic to nelarabine.

If you have any of these other conditions, you may need a dose adjustment or special tests:

• 
  

  liver disease;

  
  


• 
  

  kidney disease;

  
  


• 
  

  a nerve disorder;

  
  


• 
  

  a history of radiation treatment of your head, neck, or spinal cord; or

  
  


• 
  

  a history of cancer medicine injected around your spinal cord.

  
  

FDA pregnancy category D. Do not use nelarabine if you are pregnant. It could harm the unborn baby. Use effective birth control, and tell your doctor if you become pregnant during treatment. It is not known whether nelarabine passes into breast milk or if it could harm a nursing baby. Do not receive this medication without telling your doctor if you are breast-feeding a baby.

How is nelarabine given?

Nelarabine is injected into a vein through an IV. You will receive this injection in a clinic or hospital setting. Nelarabine must be given slowly, and the IV infusion can take up to 2 hours to complete.

Nelarabine can lower the blood cells that help your body fight infections. This can make it easier for you to bleed from an injury or get sick from being around others who are ill.

To be sure this medicine is helping your condition and is not causing harmful effects, your blood will need to be tested often. Your nervous system and kidney function may also need to be tested. Your cancer treatments may be delayed based on the results of these tests. Visit your doctor regularly.

What happens if I miss a dose?

Call your doctor for instructions if you miss an appointment for your nelarabine injection.

What happens if I overdose?

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

Overdose can cause paralysis or coma.

What should I avoid while receiving nelarabine?

Avoid being near people who are sick or have infections. Tell your doctor at once if you develop signs of infection.

Do not receive a "live" vaccine while using nelarabine, and avoid coming into contact with anyone who has recently received a live vaccine. There is a chance that the virus could be passed on to you. Live vaccines include measles, mumps, rubella (MMR), oral polio, typhoid, chickenpox (varicella), BCG (Bacillus Calmette and Guérin), and nasal flu vaccine. Nelarabine may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be awake and alert.

Nelarabine side effects

Nelarabine may cause serious side effects of the central nervous system. These symptoms may not go away even after you stop receiving nelarabine. Talk with your doctor if you have concerns about any possible long-term side effects.

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

• 
  

  confusion or clumsiness;

  
  


• 
  

  loss of balance or coordination;

  
  


• 
  

  weakness or trouble walking;

  
  


• 
  

  numbness and tingling in the hands, fingers, feet, or toes;

  
  


• 
  

  problems with buttoning clothes or picking up small items with your fingers;

  
  


• 
  

  blurred vision;

  
  


• 
  

  seizure (convulsions);

  
  


• 
  

  black, bloody or tarry stools; or

  
  


• 
  

  signs of infection such as fever, chills, sore throat, flu symptoms, easy bruising or bleeding (nosebleeds or bleeding gums), loss of appetite, or mouth sores.

  
  

Less serious side effects may include:

• 
  

  cough;

  
  


• 
  

  headache;

  
  


• 
  

  mild stomach pain, nausea, vomiting, diarrhea, constipation;

  
  


• 
  

  redness, pain, or swelling around the IV needle; or

  
  


• 
  

  dizziness, extreme drowsiness.

  
  

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.

Nelarabine Dosing Information

Usual Adult Dose for Acute Lymphoblastic Leukemia:

Initial dose: 1,500 mg/m2 administered intravenously over 2 hours on days 1, 3, and 5 repeated every 21 days

The dose is administered as a two-hour infusion in adult patients.

Usual Adult Dose for Lymphoma:

Initial dose: 1,500 mg/m2 administered intravenously over 2 hours on days 1, 3, and 5 repeated every 21 days

The dose is administered as a two-hour infusion in adult patients.

Usual Pediatric Dose for Acute Lymphoblastic Leukemia:

Initial dose: 650 mg/m2 administered intravenously over 1 hour daily for 5 consecutive days repeated every 21 days.

The dose is administered as a one-hour infusion in pediatric patients.

Usual Pediatric Dose for Lymphoma:

Initial dose: 650 mg/m2 administered intravenously over 1 hour daily for 5 consecutive days repeated every 21 days.

The dose is administered as a one-hour infusion in pediatric patients.

What other drugs will affect nelarabine?

Before receiving nelarabine, tell your doctor if you are also using pentostatin (Nipent).

There may be other drugs that can interact with nelarabine. 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 nelarabine resources

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

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


• Nelarabine Professional Patient Advice (Wolters Kluwer)


• Nelarabine MedFacts Consumer Leaflet (Wolters Kluwer)


• Nelarabine Monograph (AHFS DI)


• Arranon Prescribing Information (FDA)


• Arranon Consumer Overview

Compare nelarabine with other medications

• Acute Lymphoblastic Leukemia
• Lymphoma

Where can I get more information?

• Your doctor or pharmacist can provide more information about nelarabine.

See also: nelarabine side effects (in more detail)

Agitation Medications

Drugs associated with Agitation

The following drugs and medications are in some way related to, or used in the treatment of Agitation. This service should be used as a supplement to, and NOT a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners.

Topics under Agitation

• Agitated State (2 drugs)

• ICU Agitation (11 drugs)

Learn more about Agitation

Medical Encyclopedia:

• Agitation

Drug List:

Duo-Vil-2-10

Etrafon-2-10

Etrafon-Forte

Triavil

Zyprexa-Intramuscular

Hyalgan L/L Injection

Generic Name: hyaluronic acid (Injection route)

hye-al-ure-ON-ate AS-id

Commonly used brand name(s)

In the U.S.

• Euflexxa


• Hyalgan


• Hyalgan L/L


• Orthovisc


• Supartz

Available Dosage Forms:

• Solution

Therapeutic Class: Cartilaginous Defect Repair Agent

Uses For Hyalgan L/L

Hyaluronic acid injection is used to treat knee pain caused by osteoarthritis (OA) in patients who have already been treated with pain relievers (e.g., acetaminophen) and other treatments that did not work well.

Hyaluronic acid is similar to a substance that occurs naturally in the joints. It works by acting like a lubricant and shock absorber in the joints and helps the joints to work properly.

This medicine is to be administered only by or under the immediate supervision of your doctor.

Before Using Hyalgan L/L

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 hyaluronic acid injection in the pediatric population. Safety and efficacy have not been established.

Geriatric

No information is available on the relationship of age to the effects of hyaluronic acid injection in geriatric patients.

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 this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

• Allergy to bacterial proteins, gram positive or


• Allergy to hyaluronate preparations or


• Skin or knee joint infections or other problems at the place where the injection is to be given—Should not be given in patients with these conditions.

• Joint effusion (too much fluid in the knees)—Patients with this condition should be treated first before receiving this medicine.

Proper Use of hyaluronic acid

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

A nurse or other trained health professional will give you this medicine. This medicine is given as a shot into your knee joint. It may take more than one injection for the pain to go away.

You will receive a series of shots of this medicine one week apart for a total of three or four injections.

Precautions While Using Hyalgan L/L

Your doctor will check your progress closely while you are receiving this medicine. This will allow your doctor to see if the medicine is working properly and to decide if you should continue to receive it.

Do not strain your knee joint for two days after receiving this medicine. Avoid activities such as jogging, soccer, tennis, heavy lifting, or standing on your feet for a long time.

Temporary pain or swelling in the knee joint may occur after receiving hyaluronic acid injection. Call your doctor if the pain or swelling in the knee persists or becomes worse after receiving this medicine.

Do not use this medicine with disinfectants containing quaternary ammonium salts (e.g., benzalkonium chloride). This may prevent hyaluronic acid injection from working properly.

Hyalgan L/L Side Effects

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

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

More common

• Difficulty with moving


• muscle pain or stiffness


• pain in the joints

Less common

• Swelling or redness in the joints

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

• Bleeding, blistering, burning, coldness, discoloration of the skin, feeling of pressure, hives, infection, inflammation, itching, lumps, numbness, pain, rash, redness, scarring, soreness, stinging, swelling, tenderness, tingling, ulceration, or warmth at the injection site

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

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

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

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

Aredia Dry Powder

AREDIA DRY POWDER 15, 30, 60 and 90 mg

(pamidronate disodium)

What you need to know about Aredia Dry Powder

Your doctor has decided that you need this medicine to help treat your condition.

Please read this leaflet carefully before you start to take your medicine. It contains important information. Keep the leaflet in a safe place because you may want to read it again.

If you have any other questions, or if there is something you don’t understand, please ask your doctor or pharmacist.

This medicine has been prescribed for you. Never give it to someone else. It may not be the right medicine for them even if their symptoms seem to be the same as yours.

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

This medicine will usually be referred to just as Aredia in this leaflet.

In this leaflet:

• 1. What Aredia is and what it’s used for


• 2. Things to consider before you start to take Aredia


• 3. How to take Aredia


• 4. Possible side effects


• 5. How to store Aredia


• 6. Further information

What Aredia is and what it’s used for

The Aredia pack includes vials containing the Aredia powder, and ampoules containing Water for Injections. These are used to make up the injection solution.

The active ingredient in Aredia is called pamidronate disodium. This is one of a group of medicines called biphosphonates which can help to regulate the amount of calcium in the blood.

High blood calcium levels (hypercalcaemia) occur in a number of conditions, including some types of cancer. Often, hypercalcaemia is caused by the release of calcium from bones. Aredia sticks to bones and helps to reduce the release of calcium into the blood. If untreated, hypercalcaemia can cause symptoms such as nausea, tiredness and confusion.

Aredia is used to treat high blood calcium levels caused by some cancers. In some patients with cancer, it is also used to treat bone disease and to help relieve bone pain.

Aredia is also used to treat Paget’s disease.

Things to consider before you take Aredia

Some people MUST NOT take Aredia. Talk to your doctor if:

• you think you may be allergic to Aredia or any other biphosphonate, or to the other ingredients of Aredia powder (these are listed at the end of the leaflet).


• you are pregnant or breastfeeding.

Aredia is not suitable for treating children.

You should also ask yourself these questions before taking Aredia:

• Do you suffer from any kidney disease?


• Do you suffer from any heart problems?


• Do you have any liver problems?


• Have you ever had thyroid problems?


• Are you likely to suffer from calcium or Vitamin D deficiency?


• Have you had any problems with your teeth or jaw?


• Are you suffering from a feverish illness e.g. flu or something similar?

If the answer to any of these questions is YES, tell your doctor or nurse because Aredia might not be the right medicine for you.

Are you taking other medicines?

Some medicines can interfere with your treatment. Tell the doctor or nurse if you are taking any of the following:

• Other medicines for high calcium levels such as calcitonin


• Other biphosphonates


• Other medicines that may affect the kidneys (Your doctor or nurse will know which drugs these are.)


• Thalidomide (used to treat some cancers).

Always tell your doctor about all the medicines you are taking. This means medicines you have bought yourself as well as medicines on prescription from your doctor.

Other special warnings

• Because treatment with Aredia may affect your jaw bone, you must make sure that your dentist knows that you are having Aredia before you have any dental treatment or surgery.


• You must make sure that you do not become dehydrated while you are being treated with Aredia. Talk to your doctor to make sure you are aware how much you must drink.


• Whilst you are being treated with Aredia, your doctor will want to check your progress by carrying out a number of tests e.g. blood tests and kidney function tests. Remind your doctor you are taking Aredia before he/she does any tests. Aredia may affect the results.

Will there be any problems with driving or using machinery?

If you feel sleepy or dizzy after being treated with Aredia, do not drive or use machinery until these effects wear off.

How to take Aredia

Your doctor will have decided on the right dose depending on your condition.

A doctor or nurse will prepare the injection by dissolving Aredia powder in the water provided and then diluting this solution with a special infusion fluid. The made-up solution must be stored in a refrigerator and used with 24 hours.

Aredia is given by very slow injection into a vein (intravenous infusion). The infusion will take from one to several hours depending on the dose. Your doctor will decide how many infusions you need and how often they will be given.

Dosage guidelines are as follows:

For hypercalcaemia

15-90 mg given as a single or several infusions.

For bone diseases and bone pain

90 mg every 4 weeks. In some patients the dose may be given every 3 weeks at the same time as chemotherapy.

For Paget’s disease

180 mg given as either 30 mg once a week for 6 weeks, or 60 mg every other week for 6 weeks

Your doctor may also give you a test dose of 30 mg to see how you respond to the treatment.

Your doctor may also have prescribed treatment with Calcium and Vitamin D at the same time as Aredia.

What if you have had too much Aredia? (Overdose)

If you think you have either been given or have taken too much Aredia tell your doctor or nurse straight away. If you think you have either been given it or have taken it too often, also tell your doctor or nurse straight away.

What if you miss a dose of Aredia?

If you miss one of your appointments, please let your doctor or nurse know immediately.

Possible side effects

Aredia is suitable for most people, but, like all medicines, it can sometimes cause side effects. The side effects are usually mild and disappear as treatment continues. It is sometimes not clear whether the symptoms are related to your illness or to your treatment.

A very common effect is a mild fever with flu like symptoms such as sore throat, shivering, high temperature or hot flushes, which occur at the start of treatment and last for 24-48 hours. Some patients notice an increase in bone pain soon after starting treatment. This usually improves after a few days. If it does not, tell your doctor.

Some side effects can be serious

Tell the doctor straight away if you notice:

• Bronchospasm with wheezing or coughing and difficulty in breathing, or swelling of your face, lips or hands.


• If you feel faint (you might have low blood pressure), have a rash, or experience itching or facial swelling.

These might be the result of an allergic reaction which is very rare (likely to affect fewer than 1 in 10,000 patients).

The side effects listed below have also been reported.

Up to 1 in 10 people have experienced:

• Pain, redness or swelling at the infusion site


• Skin rash or unexplained bruising/increased bleeding


• Joint or muscle pain


• Nausea, vomiting , loss of appetite, stomach pain, gastritis, constipation or diarrhoea


• Headache, sleeplessness, tiredness


• Conjunctivitis


• Tingling in hands and feet and muscle spasms (symptoms of low level of calcium)


• High blood pressure


• Low level of white blood cells (leucopenia) or red blood cells (anaemia)


• Changes in blood test results (including low potassium, low phosphate, low magnesium and raised serum creatinine levels or, very rarely, raised potassium or sodium levels).

Up to 1 in 100 people have experienced:

• Muscle cramps


• Dizziness, lethargy, feeling agitated, seizures


• Problems with vision, painful red eyes


• Low blood pressure


• Itching, indigestion


• Deterioration of kidney function (e.g. unexpected change in the amount of urine produced and/or its appearance), abnormal liver function tests or increases in serum urea


• Problems with teeth or jaw.

Up to 1 in 1,000 people have experienced:

A change in kidney function known as glomerulosclerosis, some of the symptoms of this condition may be, fluid retention, nausea and fatigue. Tell your doctor if you suspect that you might have these symptoms

Up to 1 in 10,000 people have experienced:

• Cardiac effects which may include a difficulty in breathing and fluid retention


• Worsening of an existing kidney problem e.g. blood in urine


• A flare-up of cold sores or shingles


• Confusion or visual hallucinations (seeing things that are not there).

If any of the symptoms become troublesome, or if you notice anything else not mentioned here, please go and see your doctor.

How to store Aredia

The vials of Aredia powder before they are made up into the injection should be stored below 30°C. The made-up solution must be stored in a refrigerator and used with 24 hours.

Any unused solution should be thrown away.

Keep out of the reach and sight of children.

Do not use Aredia after the expiry date which is printed on the outside of the pack.

If your doctor tells you to stop taking Aredia and you have been keeping some at home, please take any unused vials back to your pharmacist to be destroyed. Do not
throw them away with your normal household water or waste. This will help to protect the environment.

Further information

Aredia is available in clear glass vials containing either 15, 30, 60 or 90 mg of pamidronate disodium powder. The vials also contain the inactive ingredients mannitol and phosphoric acid.

Aredia packs contain 1, 2 or 4 vials of powder. Each pack also contains 1 ampoule of water (5 ml ampoules for 15 and 30 mg vials and 10 ml ampoules for 60 and 90 mg vials) for every Aredia vial.

Not all of the pack sizes are marketed.

The product licence holder is

Novartis Pharmaceuticals UK Limited

trading as Ciba Laboratories

Frimley Business Park

Frimley

Camberley

Surrey

GU16 7SR

England

The manufacturer responsible for the release on to the market is

Novartis Pharmaceuticals UK Limited

Wimblehurst Road

Horsham

West Sussex

RH12 5AB

England

This leaflet was revised in January 2007.

If you would like any more information, or would like the leaflet in a different format, please contact Medical Information at Novartis Pharmaceuticals UK Ltd, telephone number 01276 698370.

AREDIA is a registered Trade Mark

Copyright Novartis Pharmaceuticals UK Limited

Ziagen

Generic Name: abacavir (Oral route)

a-BAK-a-vir

Oral route(Tablet;Solution)

Serious hypersensitivity reactions, lactic acidosis, severe hepatomegaly with steatosis (including fatal cases) have been reported. Risk is increased in patients carrying the HLA-B*5701 allele. Discontinue if hypersensitivity reaction is suspected and do not restart .

Commonly used brand name(s)

In the U.S.

• Ziagen

Available Dosage Forms:

• Tablet


• Solution

Therapeutic Class: Antiretroviral Agent

Pharmacologic Class: Nucleoside Reverse Transcriptase Inhibitor

Uses For Ziagen

Abacavir is used together with other medicines to treat human immunodeficiency virus (HIV) infection. HIV is the virus that causes acquired immunodeficiency syndrome (AIDS).

Abacavir will not cure or prevent HIV infection or the symptoms of AIDS. It helps keep the HIV virus from reproducing, and appears to slow the destruction of the immune system. This may help delay the development of serious health problems that are usually related to AIDS or HIV infection. Abacavir will not keep you from spreading HIV to other people. People who receive this medicine may continue to have other problems related to AIDS or HIV infection.

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

Before Using Ziagen

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 abacavir in infants younger than 3 months of age. 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 abacavir in the elderly. However, elderly patients are more likely to have age-related liver, kidney, or heart problems, which may require caution and an adjustment in the dose for patients receiving abacavir.

Pregnancy

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

Breast Feeding

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

Interactions with Medicines

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

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

• Ribavirin

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.

• Methadone


• Tipranavir

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:

• Diabetes or


• Heart disease or


• Hyperlipidemia (high cholesterol or fats in the blood) or


• Hypertension (high blood pressure)—Use with caution. May make these conditions worse.

• Genetic condition (e.g., gene variation called HLA-B*5701)—This condition may increase the risk for serious and life-threatening side effects.

• Liver disease, moderate or severe—Should not be used in patients with this condition.

Proper Use of Ziagen

Take this medicine exactly as directed by your doctor. Do not take more of it, do not take it more often, and do not take it for a longer time than your doctor ordered. Also, do not stop taking this medicine without checking first with your doctor.

It is important to take abacavir together with other HIV medicines. Take all of the medicines your doctor prescribed at the right time of day. These medicines work best when there is a constant amount in the blood. To help keep the amount constant, do not miss any doses. If you need help with planning the best times to take your medicines, check with your doctor.

When your supply of this medicine runs low, get more from your pharmacy or from your doctor. The amount of virus in your blood may increase if the medicine is stopped, even for a short time. The virus may develop resistance to this medicine and be harder to treat.

You may take this medicine with or without food.

Measure the oral liquid with a marked measuring spoon, oral syringe, or medicine cup.

This medicine will come with a Medication Guide. Read and follow these instructions carefully. Read the guide again each time you refill your prescription in case there is new information. Talk to your doctor if you have any questions.

Use only the medicine that your doctor prescribed. Do not share your medicine with others.

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 oral dosage forms (solution or tablets):
  
  • For HIV infection:
    
    • Adults—300 milligrams (mg) two times per day or 600 mg once per day.
    
    
    • Children and infants 3 months of age and older—Dose is based on body weight and must be determined by your child's doctor. The dose is usually 8 milligrams (mg) per kilogram (kg) of body weight two times per day.
    
    
    • Infants younger than 3 months of age—Use and dose must be determined by your child's 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

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

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

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

You may also store the oral liquid in the refrigerator, but do not freeze it.

Precautions While Using Ziagen

It is very important that your doctor check the progress of you or your child at regular visits to make sure that this medicine is working properly. Blood tests may be needed to check for unwanted effects.

This medicine may cause a severe allergic reaction in some patients. This reaction usually occurs within 6 weeks after the medicine is started but may occur at any time. If untreated, it can lead to severe low blood pressure and even death. Stop taking this medicine and check with your doctor immediately if you or your child notice sudden fever, skin rash, diarrhea, nausea, stomach pain, vomiting, or a feeling of unusual tiredness or illness, cough, shortness of breath, or sore throat.

When you begin taking this medicine, you or your child will be given a warning card which describes symptoms of severe allergic reactions that may be caused by abacavir. The warning card also provides information about how to treat these allergic reactions. For your safety, you should carry the warning card with you at all times.

Do not stop using this medicine unless your doctor tells you to do so. If you stop using this medicine for any reason, do not start taking it again without talking first to your doctor.

If you must stop using abacavir because of an allergic reaction, you should never use the medicine again. Return the unused medicine to your doctor or pharmacist. A worse reaction, possibly even death, can occur if you use the medicine again. Tell your doctor right away if you or your child have ever taken abacavir, especially if you have experienced an allergic reaction to it in the past.

Two rare but serious reactions to this medicine are lactic acidosis (too much acid in the blood) and liver toxicity, which includes an enlarged liver. These are more common if you are female, very overweight (obese), or have been taking anti-HIV medicines for a long time. Call your doctor right away if you or your child have more than one of these symptoms: stomach discomfort or cramping; dark urine; decreased appetite; diarrhea; general feeling of discomfort; light-colored stools; muscle cramping or pain; nausea; unusual tiredness or weakness; trouble breathing; vomiting; or yellow eyes or skin.

When you start taking HIV medicines, your immune system may get stronger. If you or your child have certain infections that are hidden in your body, such as pneumonia or tuberculosis, you may notice new symptoms when your body tries to fight them. If this occurs, tell your doctor right away.

This medicine will not keep you from giving HIV to your partner during sex. Make sure you understand and practice safe sex, such as using latex condoms, even if your partner also has HIV. Do not share needles, toothbrushes, and razor blades with anyone.

This medicine may cause you to have excess body fat. Tell your doctor if you or your child notice changes in your body shape, such as an increased amount of fat in the upper back and neck, or around the chest and stomach area; or a loss of fat from the legs, arms, and face.

This medicine may increase your risk of having a heart attack. This is more likely to occur if you smoke or already have heart disease, high blood pressure, or high cholesterol or fats in the blood. Call your doctor right away if you have chest pain or discomfort; nausea; pain or discomfort in the arms, jaw, back or neck; shortness of breath; sweating; or vomiting. These could be symptoms of a heart attack.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

Ziagen 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:

Less common

• Abdominal or stomach pain


• cough


• diarrhea


• difficult or labored breathing


• fever


• headache


• joint or muscle pain


• nausea


• numbness or tingling of the hands, feet, or face


• redness and soreness of the eyes


• shortness of breath


• skin rash


• sore throat


• sores in the mouth


• swelling of the feet or lower legs


• unusual feeling of discomfort or illness


• unusual tiredness


• vomiting

Rare

• Abdominal or stomach swelling


• decreased appetite


• fast, shallow breathing


• sleepiness

Incidence not known

• Blistering, peeling, or loosening of the skin


• chest pain or discomfort


• chills


• dark urine


• itching


• light-colored stools


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


• red, irritated eyes


• red skin lesions, often with a purple center


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


• sweating


• unusual weakness


• upper right abdominal or stomach pain


• yellow eyes and skin

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

More common

• Headache

Less common

• Trouble with sleeping

Incidence not known

• Breast enlargement


• buffalo hump


• central obesity


• facial wasting


• gaining weight around your neck, upper back, breast, face, or waist


• peripheral wasting

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: Ziagen side effects (in more detail)

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More Ziagen resources

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

• Ziagen Prescribing Information (FDA)


• Ziagen Concise Consumer Information (Cerner Multum)


• Ziagen Monograph (AHFS DI)


• Ziagen MedFacts Consumer Leaflet (Wolters Kluwer)

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