Uvadex

Generic Name: methoxsalen (Injection route)

meth-OX-a-len

Injection route(Solution)

Methoxsalen sterile solution should be used only by physicians who have special competence in the diagnosis and treatment of cutaneous T-cell lymphoma and who have special training and experience in the UVAR(R) or UVAR(R) XTS(TM) Photopheresis System .

Commonly used brand name(s)

In the U.S.

• Uvadex

Available Dosage Forms:

• Solution


• Injectable

Therapeutic Class: Antipsoriatic

Chemical Class: Psoralen

Uses For Uvadex

Methoxsalenbelongs to the group of medicines called psoralens. It is used along with ultraviolet light (found in sunlight and some special lamps) to treat the white blood cells from your blood in a process called photopheresis. The treated white blood cells are returned to your body to control skin problems associated with cutaneous T-cell lymphoma, a cancer of the lymph system.

Methoxsalen is to be administered only by or under the supervision of your doctor or other health care professional.

Before Using Uvadex

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

Studies on this medicine have been done only in adult patients, and there is no specific information comparing use of methoxsalen in children with use in other age groups.

Geriatric

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

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 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.

• Phenytoin

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:

• Albinism (pigment lacking in the skin, hair, and eyes, or eyes only) or


• Erythropoietic protoporphyria or


• Lupus erythematosus or


• Porphyria cutanea tarda or


• Skin cancer or


• Variegate porphyria or


• Xeroderma pigmentosum—Methoxsalen treatment may make condition worse

• Eye problems, such as cataracts or loss of the lens of the eye—Methoxsalen and light treatment may make these conditions worse or may cause damage to the eye

Proper Use of Uvadex

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.

Precautions While Using Uvadex

Eating certain foods while you are receiving methoxsalen treatment may increase your skin's sensitivity to sunlight. To help prevent this, avoid eating limes, figs, parsley, parsnips, mustard, carrots, and celery while you are being treated with this medicine.

Your doctor should check your progress at regular visits to make sure this treatment is working and that it does not cause unwanted effects. You also should have regular eye examinations.

This medicine increases the sensitivity of your skin to sunlight and also may cause premature aging of the skin. Therefore, exposure to the sun, even through window glass or on a cloudy day, could cause a serious burn. If you must go out during the daylight hours:

• After each treatment, cover your skin with protective clothing for at least 24 hours. In addition, use a sun block product that has a skin protection factor (SPF) of at least 15 on those areas of your body that cannot be covered. If you have any questions about this, check with your health care professional.

For 24 hours after your methoxsalen treatment, your eyes should be protected during daylight hours with special wraparound sunglasses that totally block or absorb ultraviolet light (ordinary sunglasses are not adequate). This is to prevent cataracts. Your doctor will tell you what kind of sunglasses to use. These glasses should be worn even in indirect light, such as light coming through a window, or on a cloudy day.

Uvadex 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:

Rare

• Fever


• irregular heartbeat


• redness or pain at catheter site

Symptoms of overdose

• Blistering and peeling of skin


• reddened, sore 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:

• Reddening of skin, slight

Treatment with this medicine usually causes a slight reddening of your skin 24 to 48 hours after the treatment. This is an expected effect and is no cause for concern. However, check with your doctor right away if your skin becomes sore and red or blistered.

There is an increased risk of developing skin cancer after use of methoxsalen. You should check your body regularly and show your doctor any skin sores that do not heal, new skin growths, or skin growths that have changed in the way they look or feel.

Premature aging of the skin may occur as a result of prolonged methoxsalen therapy. This effect is permanent and is similar to what happens when a person sunbathes for long periods of time.

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: Uvadex side effects (in more detail)

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

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

More Uvadex resources

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

• Uvadex Prescribing Information (FDA)


• Methoxsalen Professional Patient Advice (Wolters Kluwer)


• 8-MOP Hard-Gelatin Capsules MedFacts Consumer Leaflet (Wolters Kluwer)


• 8-MOP Prescribing Information (FDA)


• 8-Mop Concise Consumer Information (Cerner Multum)


• Oxsoralen-Ultra Soft-Gelatin Capsules MedFacts Consumer Leaflet (Wolters Kluwer)


• Oxsoralen-Ultra Prescribing Information (FDA)

Compare Uvadex with other medications

• Cutaneous T-cell Lymphoma

Lidocaine Hydrochloride Injection BP 1% w / v

LIDOCAINE HYDROCHLORIDE INJECTION 1%

This leaflet will provide you with important information about your medicine. Please read it carefully before your medicine is administered. If, after reading it, you still have some questions, please speak to your doctor, nurse or pharmacist.

What’s in your medicine?

The active ingredient in this medicine is lidocaine hydrochloride. This is the new name for lignocaine hydrochloride. The ingredient itself has not changed.

Lidocaine Hydrochloride Injection 1% is a clear, colourless, sterile solution in a clear glass ampoule containing 2, 5, 10 or 20 ml. It contains 10 mg of the active ingredient lidocaine hydrochloride in each 1 ml of solution.

It also contains the following inactive ingredients: hydrochloric acid, sodium hydroxide and water for injections.

About your medicine

Lidocaine hydrochloride is a local anaesthetic. It numbs the area of the body where it is administered. It may also be used after heart attacks.

Holder of Product Licence:

hameln pharmaceuticals ltd

Gloucester

United Kingdom

Manufacturer:

hameln pharmaceuticals gmbh

Langes Feld 13

31789 Hameln

Germany

PL 01502/0002R

Uses

Lidocaine Hydrochloride Injection 1% may be used to:

• Produce local anaesthesia and stop pain being felt in the area of the body where it is administered.


• Suppress extra heartbeats and racing heart especially after a heart attack.

Before you receive your medicine

Lidocaine hydrochloride should not be used in patients who are allergic to lidocaine hydrochloride, or to one or more of the ingredients of Lidocaine Hydrochloride Injection 1%.

Tell your doctor if you ever had an allergic or bad reaction, for example, skin rash or breathlessness, to any local anaesthetic medicines.

Before you receive this medicine, you should also tell your doctor if:

• you suffer from heart, lung or breathing disorder


• you have kidney or liver disease


• you are feeling unwell or run down for any reason


• you suffer from epilepsy or have fits


• you are pregnant or breast-feeding


• you have inflammation or infection in the area to be injected

You should also tell your doctor if you are taking any other medication, in particular any of the following:

• cimetidine (for stomach ulcer or heartburn)


• beta-blockers, for example, propranolol, (for angina, high blood pressure or other heart problems).

Driving and Operating Machinery:

Depending on where and how lidocaine hydrochloride is used, it may affect your ability to drive or operate machinery. Ask your doctor about when it would be safe to drive or operate machines.

How your medicine is administered

Lidocaine hydrochloride may be given by injection into a vein, a muscle or under the skin, by drip into a vein, or into the epidural space near the spinal cord.

Adults:

As a guide, 20 ml is the usual maximum dose. Your doctor will decide on the most appropriate dose for you. A smaller dose may be used if you are elderly or weak.

Children:

A smaller dose is usually used for children depending on their age, physical condition and the procedure to be performed.

After you receive your medicine

Like all medicines, Lidocaine Hydrochloride Injection 1% can have side effects:

Lidocaine is generally well tolerated, but along with its needed effects, all medicine can cause unwanted effects. Lidocaine may occasionally cause the following side effects:

• pain, inflammation or numbness at the site of injection after the effects of the injection should
  have worn off


• nervousness


• tremor


• blurred or double vision


• dizziness or drowsiness


• convulsions (seizures)


• nausea or vomiting


• slowed heart beat or low blood pressure

Allergic reactions to lidocaine hydrochloride are rare, but tell your doctor immediately if you get any difficulty with your breathing, a rash or itchy skin.

After spinal injection of lidocaine, you should tell your doctor if you experience any of the following
side effects:

• pain or numbness in the back or lower legs


• difficulty in walking


• problems with controlling your bladder or bowels


• faintness or lightheaded feeling


• slow heart rate or pulse rate

If you notice any side effects not mentioned in this leaflet, please inform your doctor or pharmacist.

For patients going home before the numbness or loss of feeling caused by a local anaesthetic wears off:

During the time that the injected area feels numb, serious injury can occur without your knowing about it. Be especially careful to avoid injury until the anaesthetic wears off or feeling returns to the area.

Storing your medicine

The ampoules should be stored protected from light, at less than 25°C and out of reach of children. Your doctor will not use the drug after the expiry date shown on the ampoule and carton. If only part of an ampoule is used, the remainder should be discarded.

This leaflet was prepared on August 6^th 2004.

43829/18/04

aspirin and dipyridamole

Generic Name: aspirin and dipyridamole (AS pi rin and dye peer ID a mole)

Brand Names: Aggrenox

What is aspirin and dipyridamole?

Aspirin is in a group of drugs called salicylates (sa-LIS-il-ates). It works by reducing substances in the body that cause pain, fever, and inflammation.

Dipyridamole keeps platelets in your blood from sticking together to form clots.

The combination of aspirin and dipyridamole is used to reduce the risk of stroke in people who have had blood clots or a "mini-stroke" (also called a transient ischemic attack or TIA).

Aspirin and dipyridamole may also be used for other purposes not listed in this medication guide.

What is the most important information I should know about aspirin and dipyridamole?

Do not use this medication without telling your doctor if you are pregnant. It could cause harm to the unborn baby. Use an effective form of birth control, and tell your doctor if you become pregnant during treatment. Do not use any other over-the-counter pain medication without first asking your doctor or pharmacist. Aspirin, salicylates, and NSAIDs (non-steroidal anti-inflammatory drugs) are contained in many medicines available over the counter. If you take certain products together you may accidentally take too much of a certain type of drug. Read the label of any other medicine you are using to see if it contains aspirin, ibuprofen, naproxen, ketoprofen, magnesium and/or choline salicylate. Aspirin should not be given to a child or teenager who has a fever, especially if the child also has flu symptoms or chicken pox. Aspirin can cause a serious and sometimes fatal condition called Reye's syndrome in children.

Stop using this medication and call your doctor at once if you have any symptoms of bleeding in your stomach or intestines. Symptoms include weakness or fainting, black, bloody, or tarry stools, and coughing up blood or vomit that looks like coffee grounds.

Avoid drinking alcohol while you are taking aspirin and dipyridamole. Alcohol may increase your risk of stomach bleeding. If you drink more than three alcoholic beverages per day, do not take aspirin and dipyridamole without your doctor's advice.

What should I discuss with my healthcare provider before taking aspirin and dipyridamole?

Aspirin should not be given to a child or teenager who has a fever, especially if the child also has flu symptoms or chicken pox. Aspirin can cause a serious and sometimes fatal condition called Reye's syndrome in children. Do not use this medication if you are allergic to aspirin or dipyridamole (Persantine), or if you have:

• 
  

  asthma;

  
  


• 
  

  nasal polyps; or

  
  


• 
  

  a history of allergy to an NSAID (non-steroidal anti-inflammatory drug) such as Advil, Motrin, Aleve, Orudis, Indocin, Lodine, Voltaren, Toradol, Mobic, Relafen, Feldene, and others.

  
  

Before taking aspirin and dipyridamole, tell your doctor if you are allergic to any drugs, or if you have:

• 
  

  a history of stomach ulcers or bleeding;

  
  


• 
  

  a bleeding disorder such as hemophilia;

  
  


• 
  

  heart disease, congestive heart failure, or recent heart attack;

  
  


• liver disease;


• kidney disease; or


• 
  

  low blood pressure.

  
  

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

FDA pregnancy category D. This medication can cause harm to an unborn baby. Do not use aspirin and dipyridamole without telling your doctor if you are pregnant. It could harm the unborn baby. Use effective birth control, and tell your doctor if you become pregnant during treatment. Aspirin and dipyridamole 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 aspirin and dipyridamole?

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.

Take each dose with a full glass (8 ounces) of water.

You may take aspirin and dipyridamole with or without food.

Do not crush, chew, break, or open an extended-release capsule. Swallow the pill whole. It is specially made to release medicine slowly in the body. Breaking or opening the pill would cause too much of the drug to be released at one time.

Taking the combination of aspirin and dipyridamole (Aggrenox) is not equivalent to taking each of the medications separately. Take only the medication your doctor has prescribed.

If you need to have any type of surgery, tell the surgeon ahead of time that you are taking aspirin. You may need to stop using the medicine for a short time.

Store aspirin and dipyridamole at room temperature away from moisture and heat.

See also: Aspirin and dipyridamole dosage (in more detail)

What happens if I miss a dose?

Take the missed dose as soon as you remember. If it is almost time for the next dose, skip the missed dose and wait until your next regularly scheduled dose. Do not use 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 warmth or tingly feeling, sweating, restlessness, dizziness, weakness, feeling light-headed, or fainting.

What should I avoid while taking aspirin and dipyridamole?

Avoid drinking alcohol while you are taking aspirin. Alcohol may increase your risk of stomach bleeding. Do not use any other over-the-counter pain medication without first asking your doctor or pharmacist. Aspirin, salicylates, and NSAIDs (non-steroidal anti-inflammatory drugs) are contained in many medicines available over the counter. If you take certain products together you may accidentally take too much of a certain type of drug. Read the label of any other medicine you are using to see if it contains aspirin, ibuprofen, naproxen, ketoprofen, magnesium and/or choline salicylate.

Aspirin and dipyridamole 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. Stop using this medication and call your doctor at once if you have any of these serious side effects:

• 
  

  weakness or fainting;

  
  


• 
  

  black, bloody, or tarry stools;

  
  


• 
  

  coughing up blood or vomit that looks like coffee grounds;

  
  


• 
  

  severe nausea, vomiting, or stomach pain;

  
  


• 
  

  fever lasting longer than 3 days;

  
  


• 
  

  swelling, or pain lasting longer than 10 days; or

  
  


• 
  

  hearing problems, ringing in your ears.

  
  

Less serious side effects may include:

• 
  

  upset stomach, mild heartburn, nausea, vomiting, diarrhea;

  
  


• 
  

  joint pain;

  
  


• 
  

  drowsiness; or

  
  


• 
  

  headache.

  
  

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.

Aspirin and dipyridamole Dosing Information

Usual Adult Dose for Ischemic Stroke -- Prophylaxis:

1 capsule (25 mg aspirin/200 mg extended-release dipyridamole) orally, twice a day; 1 in the morning and 1 in the evening.

What other drugs will affect aspirin and dipyridamole?

Before taking aspirin and dipyridamole, tell your doctor if you are using any of the following drugs:

• 
  

  acetazolamide (Diamox);

  
  


• 
  

  methotrexate (Rheumatrex, Trexall);

  
  


• 
  

  diabetes medications that you take by mouth;

  
  


• 
  

  gout medications such as probenecid (Benemid) or sulfinpyrazone (Anturane);

  
  


• 
  

  an ACE inhibitor such as benazepril (Lotensin), captopril (Capoten), enalapril (Vasotec), lisinopril (Prinivil, Zestril), quinapril (Accupril), ramipril (Altace), and others;

  
  


• 
  

  Alzheimer medications such as donepezil (Aricept), galantamine (Reminyl), or rivastigmine (Exelon);

  
  


• 
  

  a beta-blocker such as atenolol (Tenormin), carvedilol (Coreg), esmolol (Brevibloc), metoprolol (Lopressor, Toprol), propranolol (Inderal, InnoPran), sotalol (Betapace), timolol (Blocadren), and others;

  
  


• 
  

  a diuretic (water pill) such as amiloride (Midamor, Moduretic), furosemide (Lasix), hydrochlorothiazide (HCTZ, HydroDiuril, Hyzaar, Lopressor, Vasoretic, Zestoretic), spironolactone (Aldactazide, Aldactone), triamterene (Dyrenium, Maxzide, Dyazide), and others;

  
  


• 
  

  seizure medication such as carbamazepine (Carbatrol, Tegretol), phenytoin (Dilantin), or phenobarbital (Luminal, Solfoton); or

  
  


• 
  

  aspirin or other NSAIDs (non-steroidal anti-inflammatory drugs) such as ibuprofen (Motrin, Advil), naproxen (Aleve, Naprosyn), indomethacin (Indocin), ketoprofen (Orudis), meloxicam (Mobic), nabumetone (Relafen), piroxicam (Feldene), and others.

  
  

This list is not complete and there may be other drugs that can interact with aspirin and dipyridamole. 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 aspirin and dipyridamole resources

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

Compare aspirin and dipyridamole with other medications

• Ischemic Stroke, Prophylaxis

Where can I get more information?

• Your pharmacist can provide more information about aspirin and dipyridamole.

See also: aspirin and dipyridamole side effects (in more detail)

milnacipran

Generic Name: milnacipran (mil NA si pran)

Brand Names: Savella

What is milnacipran?

Milnacipran affects certain chemicals in the brain called neurotransmitters. An abnormality in these chemicals is thought to be related to fibromyalgia. Milnacipran is not used to treat depression but how it works in the body is similar to how some antidepressants work.

Milnacipran is used to treat a chronic pain disorder called fibromyalgia.

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

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

Do not take milnacipran together with thioridazine (Mellaril), or a monoamine oxidase inhibitor (MAOI) such as isocarboxazid (Marplan), phenelzine (Nardil), rasagiline (Azilect), selegiline (Eldepryl, Emsam), or tranylcypromine (Parnate). You must wait at least 14 days after stopping an MAOI before you can take milnacipran. After you stop taking milnacipran, you must wait at least 5 days before you start taking an MAOI.

You may have thoughts about suicide when you first start taking this medication, especially if you are younger than 24 years old. Your doctor will need to check you at regular visits for at least the first 12 weeks of treatment.

Report any new or worsening symptoms to your doctor, such as: mood or behavior changes, anxiety, panic attacks, trouble sleeping, or if you feel impulsive, irritable, agitated, hostile, aggressive, restless, hyperactive (mentally or physically), more depressed, or have thoughts about suicide or hurting yourself. Avoid drinking alcohol. It may increase your risk of liver damage. Tell your doctor if you regularly use other medicines that make you sleepy (such as cold or allergy medicine, sedatives, narcotic pain medicine, sleeping pills, muscle relaxers, and medicine for seizures, depression, or anxiety). They can add to sleepiness caused by milnacipran. Milnacipran may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be alert.

What should I discuss with my healthcare provider before taking milnacipran?

Do not use milnacipran together with thioridazine (Mellaril), or an MAO inhibitor such as isocarboxazid (Marplan), tranylcypromine (Parnate), phenelzine (Nardil), rasagiline (Azilect), or selegiline (Eldepryl, Emsam). Serious and sometimes fatal reactions can occur when these medicines are taken with milnacipran. You must wait at least 14 days after stopping an MAO inhibitor before you can take milnacipran. After you stop taking milnacipran, you must wait at least 5 days before you start taking an MAOI. You should not use this medication if you are allergic to milnacipran, or if you have untreated or uncontrolled narrow-angle glaucoma.

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

• liver or kidney disease;


• 
  

  heart disease, high blood pressure, heart rhythm disorder;

  
  


• 
  

  seizures or epilepsy;

  
  


• 
  

  glaucoma;

  
  


• 
  

  a bleeding or blood clotting disorder such as hemophilia;

  
  


• 
  

  enlarged prostate, urination problems;

  
  


• 
  

  bipolar disorder (manic depression);

  
  


• 
  

  a history of heavy alcohol use;

  
  


• 
  

  a history of suicidal thoughts or actions; or

  
  


• 
  

  if you are allergic to aspirin or yellow food dye.

  
  

You may have thoughts about suicide while taking this medication, especially if you are younger than 24 years old. Tell your doctor if you have new or worsening depression or suicidal thoughts during the first several weeks of treatment, or whenever your dose is changed.

Your family or other caregivers should also be alert to changes in your mood or symptoms. Your doctor will need to check you at regular visits for at least the first 12 weeks of treatment.

FDA pregnancy category C. It is not known whether milnacipran will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant while using this medication. It is not known whether milnacipran 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.

Older adults may be more sensitive to the side effects of this medication.

Do not give milnacipran to anyone younger than 17 years old without the advice of a doctor.

How should I take milnacipran?

Take exactly as prescribed by your doctor. Do not take in larger or smaller amounts or for longer than recommended. Follow the directions on your prescription label. Your doctor may occasionally change your dose to make sure you get the best results.

Take the medicine with food if it upsets your stomach.

Your blood pressure will need to be checked often. Visit your doctor regularly.

Do not stop using milnacipran suddenly, or you could have unpleasant withdrawal symptoms such as dizziness, anxiety, feeling irritable, confusion, headache, ringing in your ears, and sleep problems. Talk to your doctor about how to avoid withdrawal symptoms when you stop using milnacipran. Store at room temperature away from moisture and heat.

See also: Milnacipran dosage (in more detail)

What happens if I miss a dose?

Take the missed dose as soon as you remember. Skip the missed dose if it is almost time for 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 extreme drowsiness, slow heart rate, weak pulse, fainting, and slow breathing (breathing may stop).

What should I avoid while taking milnacipran?

Avoid drinking alcohol. It may increase your risk of liver damage. Milnacipran may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be alert.

Milnacipran side effects

Get emergency medical help if you have any of these signs of an allergic reaction: skin rash or hives; difficulty breathing; swelling of your face, lips, tongue, or throat. Report any new or worsening symptoms to your doctor, such as: mood or behavior changes, anxiety, panic attacks, trouble sleeping, or if you feel impulsive, irritable, agitated, hostile, aggressive, restless, hyperactive (mentally or physically), more depressed, or have thoughts about suicide or hurting yourself.

Call your doctor at once if you have any of these serious side effects:

• 
  

  pounding heartbeats or fluttering in your chest;

  
  


• 
  

  painful or difficult urination;

  
  


• 
  

  easy bruising or bleeding, nosebleeds, bloody or tarry stools, coughing up blood;

  
  


• 
  

  severe weakness, seizure (convulsions);

  
  


• 
  

  chills or goose bumps, memory problems, trouble concentrating,

  
  


• 
  

  agitation, hallucinations, fast heart rate, overactive reflexes, nausea, vomiting, diarrhea, loss of coordination, fainting;

  
  


• 
  

  very stiff (rigid) muscles, high fever, confusion, fast or uneven heartbeats, tremors, feeling like you might pass out;

  
  


• 
  

  high blood pressure (severe headache, blurred vision, buzzing in your ears, chest pain, shortness of breath, uneven heartbeats); or

  
  


• 
  

  stomach pain, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes).

  
  

Less serious side effects may include:

• 
  

  headache;

  
  


• 
  

  dizziness, drowsiness, tired feeling;

  
  


• 
  

  swelling in your hands or feet;

  
  


• 
  

  constipation, upset stomach, bloating;

  
  


• 
  

  dry mouth;

  
  


• 
  

  sleep problems (insomnia);

  
  


• 
  

  hot flashes, sweating;

  
  


• 
  

  weight changes; or

  
  


• 
  

  decreased sex drive, impotence, or difficulty having an orgasm.

  
  

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.

Milnacipran Dosing Information

Usual Adult Dose for Fibromyalgia:

Dosing should be titrated according to the following schedule:
Initial dose on day 1: 12.5 mg once
Days 2 and 3: 12.5 mg twice daily
Days 4 through 7: 25 mg twice daily
After day 7: 50 mg twice daily

Recommended maintenance dose: 50 mg twice daily

Based on individual patient response, the dose may be increased to 100 mg twice daily. Doses above 200 mg/day have not been studied.

Milnacipran should be tapered and not abruptly discontinued after extended use.

Milnacipran may be given orally with or without food. However, taking milnacipran with food may improve the tolerability of the drug.

Usual Pediatric Dose for Fibromyalgia:

17 years and older:
Dosing should be titrated according to the following schedule:
Initial dose on day 1: 12.5 mg once
Days 2 and 3: 12.5 mg twice daily
Days 4 through 7: 25 mg twice daily
After day 7: 50 mg twice daily

Recommended maintenance dose: 50 mg twice daily

Based on individual patient response, the dose may be increased to 100 mg twice daily. Doses above 200 mg/day have not been studied.

Milnacipran should be tapered and not abruptly discontinued after extended use.

Milnacipran may be given orally with or without food. However, taking milnacipran with food may improve the tolerability of the drug.

What other drugs will affect milnacipran?

Before using milnacipran, tell your doctor if you regularly use other medicines that make you sleepy (such as cold or allergy medicine, sedatives, narcotic pain medicine, sleeping pills, muscle relaxers, and medicine for seizures, depression, or anxiety). They can add to sleepiness caused by milnacipran.

Ask your doctor before taking any medicine for pain, arthritis, fever, or swelling. This includes aspirin, ibuprofen (Advil, Motrin), naproxen (Aleve, Naprosyn), diclofenac (Voltaren), indomethacin, piroxicam (Feldene), nabumetone (Relafen), etodolac (Lodine), and others. Taking any of these drugs with milnacipran may cause you to bruise or bleed easily.

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

• 
  

  a blood thinner such as warfarin (Coumadin);

  
  


• 
  

  clonidine (Catapres, Clorpres);

  
  


• 
  

  a diuretic (water pill);

  
  


• 
  

  digoxin (digitalis, Lanoxin);

  
  


• 
  

  epinephrine (Epi-Pen);

  
  


• 
  

  lithium (Lithobid, Eskalith);

  
  


• 
  

  tramadol (Ultram);

  
  


• 
  

  tryptophan (sometimes called L-tryptophan);

  
  


• 
  

  medicine to treat a psychiatric disorder;

  
  


• 
  

  medicines to treat Parkinson's disease, restless leg syndrome, or pituitary gland tumor (prolactinoma);

  
  


• 
  

  migraine headache medicine such as almotriptan (Axert), frovatriptan (Frova), naratriptan (Amerge), rizatriptan (Maxalt), sumatriptan (Imitrex, Treximet), or zolmitriptan (Zomig); or

  
  


• 
  

  an antidepressant such as citalopram (Celexa), duloxetine (Cymbalta), desvenlafaxine (Pristiq), fluoxetine (Prozac, Sarafem, Symbyax), paroxetine (Paxil), sertraline (Zoloft), or venlafaxine (Effexor).

  
  

This list is not complete and other drugs may interact with milnacipran. 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 milnacipran resources

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

• milnacipran Advanced Consumer (Micromedex) - Includes Dosage Information


• Milnacipran MedFacts Consumer Leaflet (Wolters Kluwer)


• Savella Prescribing Information (FDA)


• Savella Consumer Overview

Compare milnacipran with other medications

• Fibromyalgia
• Reflex Sympathetic Dystrophy Syndrome

Where can I get more information?

• Your pharmacist can provide more information about milnacipran.

See also: milnacipran side effects (in more detail)

Liver Fluke (Clornorchis sinensis) Medications

Drugs associated with Liver Fluke

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

Drug List:

Albenza

Biltricide

Retin-A Gel 0.025%

1. Name Of The Medicinal Product

RETIN-A^® Gel 0.025% w/w.

2. Qualitative And Quantitative Composition

Tretinoin 0.025% w/w.

Excipients:

Butylated hydroxytoluene.

For full list of excipients, see section 6.1.

3. Pharmaceutical Form

Gel.

Retin-A Gel 0.025% is a clear yellow gel.

4. Clinical Particulars

4.1 Therapeutic Indications

Treatment of acne vulgaris.

Retin-A Gel is suitable for use on oily skin.

4.2 Posology And Method Of Administration

Adults

Retin-A should be applied once or twice daily to the area of skin where acne lesions occur.

Only apply sufficient to cover the affected areas lightly, using a gauze swab, cotton wool or the tips of clean fingers. Avoid over-saturation to the extent that excess medication could run into the eyes, angles of the nose or other areas where treatment is not intended.

Initial application may cause transitory stinging and a feeling of warmth. The correct frequency of administration should produce a slight erythema similar to that of mild sunburn.

If Retin-A is applied excessively, no more rapid or better results will be obtained and marked redness, peeling or discomfort may occur. Should this occur accidentally or through over enthusiastic use, application should be discontinued for a few days.

Patience is needed in this treatment, since the therapeutic effects will not usually be observed until after 6-8 weeks of treatment. During the early weeks of treatment, an apparent exacerbation of inflammatory lesions may occur. This is due to the action of the medication on deep, previously unseen comedones and papules.

Once the acne lesions have responded satisfactorily, it should be possible to maintain the improvement with less frequent applications.

Moisturisers and cosmetics may be used during treatment with Retin-A but should not be applied to the skin at the same time. The skin should be thoroughly washed before application of Retin-A. Astringent toiletries should be avoided.

Children

The safety and efficacy of tretinoin in children aged less than 10 years has not been established.

Method of administration

Cutaneous use.

4.3 Contraindications

Retin-A is contraindicated in patients with:

- A history of sensitivity/hypersensitivity reactions to any of the components

- Pregnancy

- Personal or familial history of cutaneous epithelioma

- Acute eczemas (as tretinoin has been reported to cause severe irritation on eczematous skin)

- Rosacea and perioral dermatitis.

4.4 Special Warnings And Precautions For Use

Local irritation

The presence of cutaneous irritative signs (eg erythema, peeling, pruritus, sunburn, etc) should prohibit initiation or recommencement of treatment with Retin-A until the symptoms resolve.

In certain sensitive individuals, topical use may induce severe local erythema, swelling, pruritus, warmth, burning or stinging, blistering, crusting and/or peeling at the site of application. If the degree of local irritation warrants, the patient should be directed to apply the medication less frequently or discontinue its use temporarily. If a patient experiences severe or persistent irritation, the patient should be advised to discontinue application of Retin-A completely and, if necessary, consult a physician.

Weather extremes, such as wind or cold, also may be irritating to patients being treated with Retin-A.

Exposure to sunlight, including ultraviolet sunlamps, should be avoided or minimised during the use of tretinoin. Patients with sunburn should be advised not to use the product until fully recovered because of potential severe irritation to skin. A patient who experiences considerable sun exposure due to occupational duties and/or anyone inherently sensitive to the sun should exercise particular caution. When exposure to sunlight cannot be avoided, use of sunscreen products and protective clothing over treated areas is recommended.

General precautions for use:

Before application of Retin-A, areas to be treated should be cleansed thoroughly.

Abstain from washing the treated area frequently: twice daily is sufficient. Use of mild soap is recommended. Dry skin without rubbing.

Avoid contact with eyes, eyelids, nostrils, mouth and mucous membranes. If contact in these areas occurs, careful washing with water is recommended.

Warning:

The weight of evidence indicates that topical tretinoin is not carcinogenic. In a lifetime study of CD-1 mice, a low incidence of skin tumours was seen at 100 and 200 times the estimated clinical dose but, although no such tumours were seen in the study controls, the incidence in these treated animals was within the historic control range for CD-1 mice.

Studies in hairless albino mice suggest that tretinoin may accelerate the tumorigenic potential of UVB light from a solar simulator. In other studies, when lightly pigmented hairless mice treated with tretinoin were exposed to carcinogenic doses of UVB light, the photocarcinogenic effects of tretinoin were not observed. Due to significantly different experimental conditions, no strict comparison of this disparate data is possible. Although the significance of these studies in man is not clear, patients should avoid or minimise exposure to sunlight.

The weight of evidence indicates that topical tretinoin is not mutagenic. The mutagenic potential of tretinoin was evaluated in the Ames assay and the in vivo mouse micronucleus assay, both of which showed negative findings.

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

Retin-A should be used with caution in the presence of:

− concomitant topical medications

− toiletry preparations having a strong drying, abrasive or desquamative effect.

Following prolonged use of a peeling agent it is advisable to 'rest' a patient's skin until the effects of the peeling agent subside before the use of Retin-A is begun. When Retin-A and peeling agents are alternated contact dermatitis may result and the frequency of application may have to be reduced.

4.6 Pregnancy And Lactation

The topical human dose used in a 50 kg adult applying a maximum volume of 500 mg of 0.05% Retin-A cream is 0.005 mg/kg. In animal reproductive studies, oral tretinoin is known to be teratogenic and has been shown to be foetotoxic in rats when given in doses 500 times the topical human dose. In reproduction studies in rats and rabbits, topical tretinoin, when used at doses 500 and 320 times the topical human dose, respectively, induced minor skeletal abnormalities, eg irregularly contoured or partially ossified skull bones. These changes may be considered variants of normal development and are usually corrected after weaning. Retin-A should not be used during pregnancy.

It is not known whether tretinoin is excreted in human milk, therefore caution should be exercised when Retin-A is administered to a nursing mother.

4.7 Effects On Ability To Drive And Use Machines

Retin-A is administered topically and is unlikely to have an effect on one's ability to drive or operate machinery.

4.8 Undesirable Effects

Local reactions frequently reported during therapy included: dry or peeling skin, burning, stinging, warmth, erythema, pruritus, rash and temporary hypo- and hyper-pigmentation. These skin reactions were usually mild to moderate and were generally well-tolerated. They usually occurred early in therapy and, except for dry or peeling skin which persisted during therapy, generally decreased over the course of therapy.

Rarely reported undesirable effects are blistering and crusting of the skin, eye irritation and oedema.

True contact allergy to topical tretinoin is rarely encountered. Heightened susceptibility to either sunlight or other sources of UVB light has been reported.

4.9 Overdose

Excessive application of Retin-A does not improve the results of treatment and may induce marked irritation, eg erythema, peeling, pruritus, etc. Oral ingestion of Retin-A may lead to the same effects associated with excessive oral intake of vitamin A (eg pruritus, dry skin, arthralgias, anorexia, vomiting). In the event of accidental ingestion, if the ingestion is recent an appropriate method of gastric emptying should be used as soon as possible.

5. Pharmacological Properties

5.1 Pharmacodynamic Properties

Pharmacotherapeutic group: Retinoids for topical use in acne

ATC code: D10AD01

Tretinoin (β-all trans retinoic acid, vitamin A acid) produces profound metabolic changes in keratinizing epithelia. Tretinoin increases the proliferative activity of epidermal cells in in vivo and in vitro studies, and cellular differentiation (keratinization and cornification) is also altered.

5.2 Pharmacokinetic Properties

Absorption

Tretinoin is an endogenous metabolite of Vitamin A metabolism in man. Upon topical application, tretinoin is minimally absorbed, penetrating both the epidermis and dermis.

Percutaneous absorption of tretinoin, as determined by the cumulative excretion of radiolabeled drug into urine and feces, was assessed in healthy men and women after single and/or repeated daily applications of a 0.05%, 0.1% or 0.5% tretinoin cream formulation or a 0.01% tretinoin gel formulation, at doses of 100, 150 or 500 mg. The mean percutaneous absorption ranged from 1.0 to 4.3%. Endogenous plasma concentrations of tretinoin and its metabolites, 13-cis-retinoic acid, all-trans-4-oxo-retinoic acid and 13-cis-4-oxo-retinoic acid were essentially unaltered after either single or multiple daily applications relative to baseline levels.

Distribution

Approximately 80% of tretinoin applied remains on the skin surface, whereas its penetration through the stratum corneum and the hair follicle is vehicle-dependent. After the initial diffusion into the stratum corneum that occurs within a few minutes, further diffusion into epidermis and dermis proceeds more slowly.

Metabolism

Topically-applied tretinoin is metabolized by CYP2S1 and CYP26. Metabolites are 13-cis-retinoic acid, all-trans-4-oxo-retinoic acid and 13-cis-4-oxo-retinoic acid.

Elimination

After application of radiolabelled tretinoin emollient cream or cream, urinary excretion occurred mainly in the first 48 hours, whereas radioactivity was eliminated in the faeces throughout the 7 days after dose application. On average 1 – 1.5% of the radioactivity was recovered in urine and less than 1 % was recovered in feces.

Paediatric Population

Although there is limited data available, it is considered likely that the pharmacokinetic behaviour of tretinoin topical formulations and drug-drug interactions with tretinoin topical formulations will be similar to those in adults. In a study in 20 adolescent patients with moderate to severe acne treated for 12 weeks with tretinoin gel, none of the plasma samples obtained at Week 12 of the treatment period contained quantifiable tretinoin levels.

5.3 Preclinical Safety Data

See Sections 4.4 (Special warnings and precautions) and 4.6 (Pregnancy and lactation).

6. Pharmaceutical Particulars

6.1 List Of Excipients

Butylated hydroxytoluene

Hydroxypropyl cellulose

Undenatured ethanol

6.2 Incompatibilities

Not applicable.

6.3 Shelf Life

3 years.

6.4 Special Precautions For Storage

Do not store above 25°C.

6.5 Nature And Contents Of Container

Aluminium tube with polypropylene cap.

Aluminium tube may contain 10, 15, 20 or 60 g of gel per pack.

6.6 Special Precautions For Disposal And Other Handling

Not applicable

7. Marketing Authorisation Holder

Janssen-Cilag Ltd

50-100 Holmers Farm Way

High Wycombe

Buckinghamshire

HP12 4EG

UK

8. Marketing Authorisation Number(S)

PL 00242/0268

9. Date Of First Authorisation/Renewal Of The Authorisation

1 September 1995/21 May 2003

10. Date Of Revision Of The Text

26 October 2011

Humulin L

Generic Name: human insulin zinc suspension

Dosage Form: Lente Human Insulin Injection

INFORMATION FOR THE PATIENT

WARNINGS

THIS LILLY HUMAN INSULIN PRODUCT DIFFERS FROM ANIMAL-SOURCE INSULINS BECAUSE IT IS STRUCTURALLY IDENTICAL TO THE INSULIN PRODUCED BY YOUR BODY'S PANCREAS AND BECAUSE OF ITS UNIQUE MANUFACTURING PROCESS.

ANY CHANGE OF INSULIN SHOULD BE MADE CAUTIOUSLY AND ONLY UNDER MEDICAL SUPERVISION. CHANGES IN STRENGTH, MANUFACTURER, TYPE (E.G., REGULAR, NPH, LENTE®), SPECIES (BEEF, PORK, BEEF-PORK, HUMAN), OR METHOD OF MANUFACTURE (rDNA VERSUS ANIMAL-SOURCE INSULIN) MAY RESULT IN THE NEED FOR A CHANGE IN DOSAGE.

SOME PATIENTS TAKING HUMULIN®(HUMAN INSULIN, rDNA ORIGIN) MAY REQUIRE A CHANGE IN DOSAGE FROM THAT USED WITH ANIMAL-SOURCE INSULINS. IF AN ADJUSTMENT IS NEEDED, IT MAY OCCUR WITH THE FIRST DOSE OR DURING THE FIRST SEVERAL WEEKS OR MONTHS.

DIABETES

Insulin is a hormone produced by the pancreas, a large gland that lies near the stomach. This hormone is necessary for the body's correct use of food, especially sugar. Diabetes occurs when the pancreas does not make enough insulin to meet your body's needs.

To control your diabetes, your doctor has prescribed injections of insulin products to keep your blood glucose at a near-normal level. You have been instructed to test your blood and/or your urine regularly for glucose. Studies have shown that some chronic complications of diabetes such as eye disease, kidney disease, and nerve disease can be significantly reduced if the blood sugar is maintained as close to normal as possible. The American Diabetes Association recommends that if your premeal glucose levels are consistently above 130 mg/dL or your hemoglobin A1c (HbA1c) is more than 7%, consult your doctor. A change in your diabetes therapy may be needed. If your blood tests consistently show below-normal glucose levels, you should also let your doctor know. Proper control of your diabetes requires close and constant cooperation with your doctor. Despite diabetes, you can lead an active and healthy life if you eat a balanced diet, exercise regularly, and take your insulin injections as prescribed.

Always keep an extra supply of insulin as well as a spare syringe and needle on hand. Always wear diabetic identification so that appropriate treatment can be given if complications occur away from home.

LENTE HUMAN INSULIN

Description

Humulin is synthesized in a special non-disease-producing laboratory strain of Escherichia coli bacteria that has been genetically altered by the addition of the gene for human insulin production. Humulin L is an amorphous and crystalline suspension of human insulin with zinc providing an intermediate-acting insulin with a slower onset and a longer duration of activity (up to 24 hours) than regular insulin. The time course of action of any insulin may vary considerably in different individuals or at different times in the same individual. As with all insulin preparations, the duration of action of Humulin L is dependent on dose, site of injection, blood supply, temperature, and physical activity. Humulin L is a sterile suspension and is for subcutaneous injection. It should not be used intramuscularly. The concentration of Humulin L is 100 units/mL (U-100).

Identification

Human insulin by Eli Lilly and Company has the trademark Humulin and is available in 6 formulations — Regular (R), NPH (N), Lente (L), Ultralente® (U), 50% Human Insulin Isophane Suspension [NPH]/50% Human Insulin Injection [regular] (50/50), and 70% Human Insulin Isophane Suspension [NPH]/30% Human Insulin Injection [regular] (70/30). Your doctor has prescribed the type of insulin that he/she believes is best for you. DO NOT USE ANY OTHER INSULIN EXCEPT ON HIS/HER ADVICE AND DIRECTION.

Always check the carton and the bottle label for the name and letter designation of the insulin you receive from your pharmacy to make sure it is the same as that your doctor has prescribed.

Always examine the appearance of your bottle of insulin before withdrawing each dose. A bottle of Humulin L must be carefully shaken or rotated before each injection so that the contents are uniformly mixed. Humulin L should look uniformly cloudy or milky after mixing. Do not use it if the insulin substance (the white material) remains at the bottom of the bottle after mixing. Do not use a bottle of Humulin L if there are clumps in the insulin after mixing. Always check the appearance of your bottle of insulin before using, and if you note anything unusual in the appearance of your insulin or notice your insulin requirements changing markedly, consult your doctor.

Storage

Not in-use (unopened): Humulin L not in-use should be stored in a refrigerator (2° to 8°C [36° to 46°F]), but not in the freezer. Do not use Humulin L if it has been frozen.

In-use: Humulin L bottles in-use should be refrigerated. If refrigeration is not possible, the bottle of Humulin L that you are currently using can be kept unrefrigerated as long as it is kept at room temperature (below 30°C [86°F]), and away from heat and light. Do not use Humulin L if it has been frozen.

Do not use a bottle of Humulin L after the expiration date stamped on the label.

INJECTION PROCEDURES

NEVER SHARE NEEDLES AND SYRINGES

Correct Syringe Type

Doses of insulin are measured in units. U-100 insulin contains 100 units/mL (1 mL=1 cc). With Humulin L, it is important to use a syringe that is marked for U-100 insulin preparations. Failure to use the proper syringe can lead to a mistake in dosage, causing serious problems for you, such as a blood glucose level that is too low or too high.

Syringe Use

To help avoid contamination and possible infection, follow these instructions exactly.

Disposable plastic syringes and needles should be used only once and then discarded in a responsible manner.

Reusable glass syringes and needles must be sterilized before each injection. Follow the package directions supplied with your syringe. Described below are 2 methods of sterilizing.

Boiling

1. Put syringe, plunger, and needle in strainer, place in saucepan, and cover with water. Boil for 5 minutes.


2. Remove articles from water. When they have cooled, insert plunger into barrel, and fasten needle to syringe with a slight twist.


3. Push plunger in and out several times until water is completely removed.

Isopropyl Alcohol

If the syringe, plunger, and needle cannot be boiled, as when you are traveling, they may be sterilized by immersion for at least 5 minutes in Isopropyl Alcohol, 91%. Do not use bathing, rubbing, or medicated alcohol for this sterilization. If the syringe is sterilized with alcohol, it must be absolutely dry before use.

Preparing the Dose

1. Wash your hands.


2. Carefully shake or rotate the insulin bottle several times to completely mix the insulin.


3. Inspect the insulin. Humulin L should look uniformly cloudy or milky. Do not use Humulin L if you notice anything unusual in the appearance.


4. If using a new bottle, flip off the plastic protective cap, but do not remove the stopper. When using a new bottle, wipe the top of the bottle with an alcohol swab.


5. If you are mixing insulins, refer to the instructions for mixing that follow.


6. Draw air into the syringe equal to your insulin dose. Put the needle through rubber top of the insulin bottle and inject the air into the bottle.


7. Turn the bottle and syringe upside down. Hold the bottle and syringe firmly in one hand and shake gently.


8. Making sure the tip of the needle is in the insulin, withdraw the correct dose of insulin into the syringe.


9. Before removing the needle from the bottle, check your syringe for air bubbles which reduce the amount of insulin in it. If bubbles are present, hold the syringe straight up and tap its side until the bubbles float to the top. Push them out with the plunger and withdraw the correct dose.


10. Remove the needle from the bottle and lay the syringe down so that the needle does not touch anything.

Mixing Humulin L with Regular or Ultralente Human Insulin

1. Lente human insulin should be mixed with regular or Ultralente human insulin only on the advice of your doctor.


2. Draw air into your syringe equal to the amount of Humulin L you are taking. Insert the needle into the Humulin L bottle and inject the air. Withdraw the needle.


3. Now inject air into your regular or Ultralente human insulin bottle in the same manner, but do not withdraw the needle.


4. Turn the bottle and syringe upside down.


5. Making sure the tip of the needle is in the insulin, withdraw the correct dose of regular or Ultralente insulin into the syringe.


6. Before removing the needle from the bottle, check your syringe for air bubbles which reduce the amount of insulin in it. If bubbles are present, hold the syringe straight up and tap its side until the bubbles float to the top. Push them out with the plunger and withdraw the correct dose.


7. Remove the needle from the bottle of regular or Ultralente insulin and insert it into the bottle of Humulin L. Turn the bottle and syringe upside down. Hold the bottle and syringe firmly in one hand and shake gently. Making sure the tip of the needle is in the insulin, withdraw your dose of Humulin L.


8. Remove the needle and lay the syringe down so that the needle does not touch anything.

Follow your doctor's instructions on whether to mix your insulins ahead of time or just before giving your injection. It is important to be consistent in your method.

Syringes from different manufacturers may vary in the amount of space between the bottom line and the needle. Because of this, do not change:

• the sequence of mixing, or


• the model and brand of syringe or needle that the doctor has prescribed.

Injection

Once you have chosen an injection site, cleanse the skin with alcohol where the injection is to be made. Stabilize the skin by spreading it or pinching up a large area. Insert the needle as instructed by your doctor. Push the plunger in as far as it will go. Pull the needle out and apply gentle pressure over the injection site for several seconds. Do not rub the area. To avoid tissue damage, give the next injection at a site at least 1/2 inch from the previous injection site. The usual sites of injection are abdomen, thighs, and arms. Place the used needle in a puncture-resistant disposable container and properly dispose of it as directed by your Health Care Professional.

DOSAGE

Your doctor has told you which insulin to use, how much, and when and how often to inject it. Because each patient's case of diabetes is different, this schedule has been individualized for you.

Your usual insulin dose may be affected by changes in your food, activity, or work schedule. Carefully follow your doctor's instructions to allow for these changes. Other things that may affect your insulin dose are:

Illness

Illness, especially with nausea and vomiting, may cause your insulin requirements to change. Even if you are not eating, you will still require insulin. You and your doctor should establish a sick day plan for you to use in case of illness. When you are sick, test your blood glucose/urine glucose and ketones frequently and call your doctor as instructed.

Pregnancy

Good control of diabetes is especially important for you and your unborn baby. Pregnancy may make managing your diabetes more difficult. If you are planning to have a baby, are pregnant, or are nursing a baby, consult your doctor.

Medication

Insulin requirements may be increased if you are taking other drugs with hyperglycemic activity, such as oral contraceptives, corticosteroids, or thyroid replacement therapy. Insulin requirements may be reduced in the presence of drugs with hypoglycemic activity, such as oral antidiabetic agents, salicylates (for example, aspirin), sulfa antibiotics, and certain antidepressants. Always discuss any medications you are taking with your doctor.

Exercise

Exercise may lower your body's need for insulin during and for some time after the activity. Exercise may also speed up the effect of an insulin dose, especially if the exercise involves the area of injection site (for example, the leg should not be used for injection just prior to running). Discuss with your doctor how you should adjust your regimen to accommodate exercise.

Travel

Persons traveling across more than 2 time zones should consult their doctor concerning adjustments in their insulin schedule.

COMMON PROBLEMS OF DIABETES

Hypoglycemia (Low Blood Sugar)

Hypoglycemia (too little glucose in the blood) is one of the most frequent adverse events experienced by insulin users. It can be brought about by:

1. Taking too much insulin.


2. Missing or delaying meals.


3. Exercising or working more than usual.


4. An infection or illness (especially with diarrhea or vomiting).


5. A change in the body's need for insulin.


6. Diseases of the adrenal, pituitary, or thyroid gland, or progression of kidney or liver disease.


7. Interactions with other drugs that lower blood glucose, such as oral antidiabetic agents, salicylates (for example, aspirin), sulfa antibiotics, and certain antidepressants.


8. Consumption of alcoholic beverages.

Symptoms of mild to moderate hypoglycemia may occur suddenly and can include:

sweating dizziness palpitation tremor hunger restlessness tingling in the hands, feet, lips, or tongue lightheadedness inability to concentrate headache

drowsiness sleep disturbances anxiety blurred vision slurred speech depressed mood irritability abnormal behavior unsteady movement personality changes

Signs of severe hypoglycemia can include:

disorientation unconsciousness

seizures death

Therefore, it is important that assistance be obtained immediately.

Early warning symptoms of hypoglycemia may be different or less pronounced under certain conditions, such as long duration of diabetes, diabetic nerve disease, medications such as beta-blockers, change in insulin preparations, or intensified control (3 or more insulin injections per day) of diabetes.

A few patients who have experienced hypoglycemic reactions after transfer from animal-source insulin to human insulin have reported that the early warning symptoms of hypoglycemia were less pronounced or different from those experienced with their previous insulin.

Without recognition of early warning symptoms, you may not be able to take steps to avoid more serious hypoglycemia. Be alert for all of the various types of symptoms that may indicate hypoglycemia. Patients who experience hypoglycemia without early warning symptoms should monitor their blood glucose frequently, especially prior to activities such as driving. If the blood glucose is below your normal fasting glucose, you should consider eating or drinking sugar-containing foods to treat your hypoglycemia.

Mild to moderate hypoglycemia may be treated by eating foods or drinks that contain sugar. Patients should always carry a quick source of sugar, such as candy mints or glucose tablets. More severe hypoglycemia may require the assistance of another person. Patients who are unable to take sugar orally or who are unconscious require an injection of glucagon or should be treated with intravenous administration of glucose at a medical facility.

You should learn to recognize your own symptoms of hypoglycemia. If you are uncertain about these symptoms, you should monitor your blood glucose frequently to help you learn to recognize the symptoms that you experience with hypoglycemia.

If you have frequent episodes of hypoglycemia or experience difficulty in recognizing the symptoms, you should consult your doctor to discuss possible changes in therapy, meal plans, and/or exercise programs to help you avoid hypoglycemia.

Hyperglycemia and Diabetic Ketoacidosis (DKA)

Hyperglycemia (too much glucose in the blood) may develop if your body has too little insulin. Hyperglycemia can be brought about by:

1. Omitting your insulin or taking less than the doctor has prescribed.


2. Eating significantly more than your meal plan suggests.


3. Developing a fever, infection, or other significant stressful situation.

In patients with type 1 or insulin-dependent diabetes, prolonged hyperglycemia can result in DKA. The first symptoms of DKA usually come on gradually, over a period of hours or days, and include a drowsy feeling, flushed face, thirst, loss of appetite, and fruity odor on the breath. With DKA, urine tests show large amounts of glucose and ketones. Heavy breathing and a rapid pulse are more severe symptoms. If uncorrected, prolonged hyperglycemia or DKA can lead to nausea, vomiting, dehydration, loss of consciousness or death. Therefore, it is important that you obtain medical assistance immediately.

Lipodystrophy

Rarely, administration of insulin subcutaneously can result in lipoatrophy (depression in the skin) or lipohypertrophy (enlargement or thickening of tissue). If you notice either of these conditions, consult your doctor. A change in your injection technique may help alleviate the problem.

Allergy to Insulin

Local Allergy— Patients occasionally experience redness, swelling, and itching at the site of injection of insulin. This condition, called local allergy, usually clears up in a few days to a few weeks. In some instances, this condition may be related to factors other than insulin, such as irritants in the skin cleansing agent or poor injection technique. If you have local reactions, contact your doctor.

Systemic Allergy— Less common, but potentially more serious, is generalized allergy to insulin, which may cause rash over the whole body, shortness of breath, wheezing, reduction in blood pressure, fast pulse, or sweating. Severe cases of generalized allergy may be life threatening. If you think you are having a generalized allergic reaction to insulin, notify a doctor immediately.

ADDITIONAL INFORMATION

Additional information about diabetes may be obtained from your diabetes educator.

DIABETES FORECAST is a magazine designed especially for people with diabetes and their families. It is available by subscription from the American Diabetes Association (ADA), P.O. Box 363, Mt. Morris, IL 61054-0363, 1-800-DIABETES (1-800-342-2383).

Another publication, COUNTDOWN, is available from the Juvenile Diabetes Research Foundation International (JDRFI), 120 Wall Street 19th Floor, New York, NY 10005, 1-800-533-CURE (1-800-533-2873).

Additional information about Humulin can be obtained by calling The Lilly Answers Center at 1-800-LillyRx (1-800-545-5979).

Literature revised November 22, 2004

Eli Lilly and Company, Indianapolis, IN 46285, USA

Copyright © 1997, 2004, Eli Lilly and Company. All rights reserved.

Humulin L LENTE  human insulin and zinc oxide  injection, suspension

Product Information Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 0002-8415 Route of Administration SUBCUTANEOUS DEA Schedule

INGREDIENTS Name (Active Moiety) Type Strength insulin human (insulin human) Active 100 UNITS  In 1 MILLILITER glycerin Inactive   metacresol Inactive   zinc oxide Inactive   sodium hydroxide Inactive   hydrochloric acid Inactive

Product Characteristics Color      Score      Shape Size Flavor Imprint Code Contains

Packaging # NDC Package Description Multilevel Packaging 1 0002-8415-01 10 mL (MILLILITER) In 1 VIAL None

Revised: 12/2005Eli Lilly and Company

More Humulin L resources

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

• Humulin L Concise Consumer Information (Cerner Multum)

Compare Humulin L with other medications

• Diabetes, Type 1
• Diabetes, Type 2
• Gestational Diabetes

SymlinPen 60

Generic Name: pramlintide (PRAM lin tide)

Brand Names: Symlin, SymlinPen 120, SymlinPen 60

What is SymlinPen 60 (pramlintide)?

Pramlintide is a man-made form of a hormone that occurs naturally in the body. Pramlintide lowers blood sugar in three ways. It slows the rate that food moves from your stomach to your intestines, which keeps your blood sugar from rising too fast. Pramlintide also lowers the amount of glucose (sugar) your liver produces. Lastly, pramlintide triggers the feeling of fullness after meals to help control your appetite and decrease how much food you eat.

Pramlintide is used together with insulin to treat type 1 or type 2 diabetes.

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

What is the most important information I should know about SymlinPen 60 (pramlintide)?

Do not mix pramlintide and insulin together in the same syringe.

You will need to use a lower dose of insulin than you used before you started using pramlintide. Your doctor will determine your correct dose.

Call your doctor if you have severe nausea that lasts for several days. This may be a sign that your dose is too high. If you skip a meal, do not take your dose of pramlintide. Wait until your next meal.

If you stop using pramlintide for a short time, you may need to restart the medication at a lower dose. Do not change your doses or medication schedule without your doctor's advice.

Take care not to let your blood sugar get too low, causing hypoglycemia. Severe hypoglycemia may occur within 3 hours after your pramlintide injection. Carry hard candy or glucose tablets with you in case you have low blood sugar. Be sure your family and close friends know how to help you in an emergency.

What should I discuss with my doctor before using SymlinPen 60 (pramlintide)?

Do not use this medication if you are allergic to pramlintide or metacresol. Do not use if you have a digestive condition called "delayed gastric emptying," or if you cannot recognize symptoms of low blood sugar.

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

• 
  

  a history of delayed gastric emptying;

  
  


• 
  

  if you are unable to check your blood sugars regularly up to several times daily;

  
  


• 
  

  if you have had severe hypoglycemia more than once in the past 6 months;

  
  

FDA pregnancy category C. It is not known whether pramlintide will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant while using this medication.. It is not known whether pramlintide 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. Pramlintide should not be used in children.

How should I use SymlinPen 60 (pramlintide)?

Use pramlintide exactly as it was prescribed for you. Do not use the medication in larger or smaller amounts, or use it for longer than recommended by your doctor. You may not be able to keep using pramlintide if you do not follow the dosing instructions.

Pramlintide is injected under the skin, at the same time as your insulin injection but in a separate syringe or injector pen. Do not self-inject this medicine if you do not fully understand how to give the injection and properly dispose of used needles and syringes. Do not mix pramlintide and insulin together in the same syringe.

Use only the syringe or injection pen recommended by your doctor. Ask your pharmacist about which needles to buy for proper use of the syringe or injection pen.

Pramlintide is usually given just before each major meal. Follow your doctor's instructions. If you skip a meal, do not take your dose of pramlintide. Wait until your next meal. Pramlintide should be at room temperature when you inject it.

Use a different place on your stomach or thigh each time you give the injection. Inject your insulin in a separate skin area. Do not inject insulin or pramlintide into the same place two times in a row. Do not use the medication if it has changed colors or has particles in it. Call your doctor for a new prescription.

Use a disposable needle only one time. Throw away used needles in a puncture-proof container (ask your pharmacist where you can get one and how to dispose of it). Keep this container out of the reach of children and pets.

Call your doctor if you have severe nausea that lasts for several days. This may be a sign that your dose is too high.

If you stop using pramlintide for a short time, you may need to restart the medication at a lower dose. Follow your doctor's instructions.

You will need to use a lower dose of insulin than you used before you started using pramlintide. Your doctor will determine the correct insulin dose based on the type of diabetes you have.

Do not change your doses or medication schedule without your doctor's advice. Your blood sugar will need to be checked often, and you may need other blood tests at your doctor's office. Visit your doctor regularly.

Take care not to let your blood sugar get too low, causing hypoglycemia. Severe hypoglycemia may occur within 3 hours after your pramlintide injection. Symptoms include headache, hunger, sweating, tremor, irritability, or trouble concentrating. Carry hard candy or glucose tablets with you in case you have low blood sugar. Be sure your family and close friends know how to help you in an emergency.

Severe hypoglycemia may cause loss of consciousness, seizures, or death. If you have severe hypoglycemia and cannot eat or drink, use an injection of glucagon. Your doctor can give you a prescription for a glucagon emergency injection kit and tell you how to give the injection. Storing unopened vials or injection pens: Keep in the carton and store in a refrigerator, protected from light. Throw away any insulin not used before the expiration date on the medicine label.

Do not freeze pramlintide, and throw away the medication if it has become frozen.

Storing after your first use: You may keep "in-use" vials or injection pens in the refrigerator or at room temperature. Use within 30 days.

What happens if I miss a dose?

Take the missed dose as soon as you remember, but only if you are getting ready to eat a meal. Skip the missed dose if it is almost time for 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 may cause diarrhea, vomiting, dizziness, cold sweats, warmth or tingly feeling.

What should I avoid while using SymlinPen 60 (pramlintide)?

Do not remove pramlintide from an injector pen and put it in a syringe. You may receive too high a dose. Avoid drinking alcohol. It can lower your blood sugar.

SymlinPen 60 (pramlintide) 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:

• 
  

  severe nausea that lasts for 3 to 7 days; or

  
  


• 
  

  more frequent high blood sugar levels.

  
  

Less serious side effects may include:

• 
  

  runny or stuffy nose, sore throat, cough;

  
  


• 
  

  nausea, loss of appetite;

  
  


• 
  

  headache, tired feeling; or

  
  


• 
  

  joint pain.

  
  

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 SymlinPen 60 (pramlintide)?

The following drugs can interact with pramlintide. Tell your doctor if you are using any of these:

• 
  

  acarbose (Precose) or miglitol (Glyset);

  
  


• 
  

  disopyramide (Norpace);

  
  


• 
  

  fluoxetine (Luvox);

  
  


• 
  

  pentoxyfylline (Trental);

  
  


• 
  

  propoxyphene (Darvon, Darovcet);

  
  


• 
  

  diabetes medications you take by mouth;

  
  


• 
  

  atropine (Atreza, Sal-Tropine), dicyclomine (Bentyl), hyoscyamine (Hyomax), oxybutynin (Ditropan, Oxytrol);

  
  


• 
  

  an ACE inhibitor such as benazepril (Lotensin), fosinopril (Monopril), enalapril (Vasotec), lisinopril (Prinivil, Zestril), quinapril (Accupril), ramipril (Altace), and others; or

  
  


• 
  

  cholesterol-lowering medication such as fenofibrate (Lofibra, Fenoglide, TriCor, Lipofen) or gemfibrozil (Lopid).

  
  

Using certain medicines can make it harder for you to tell when you have low blood sugar. Tell your doctor if you use any of the following:

• 
  

  albuterol (Proventil, Ventolin);

  
  


• 
  

  clonidine (Catapres); or

  
  


• 
  

  a beta-blocker such as atenolol (Tenormin, Tenoretic), carvedilol (Coreg), labetalol (Normodyne, Trandate), metoprolol (Lopressor, Toprol), nadolol (Corgard), propranolol (Inderal, InnoPran), sotalol (Betapace), and others.

  
  

You may be more likely to have high or low blood sugar if you are using pramlintide with other drugs that raise or lower blood sugar. This includes:

• 
  

  isoniazid;

  
  


• 
  

  probenecid (Benemid);

  
  


• 
  

  aspirin or other salicylates (including Pepto-Bismol);

  
  


• 
  

  birth control pills and other hormones;

  
  


• 
  

  diet pills or medicines to treat asthma, colds or allergies;

  
  


• 
  

  diuretics (water pills);

  
  


• 
  

  a monoamine oxidase inhibitor (MAOI);

  
  


• 
  

  phenothiazines (Compazine and others);

  
  


• 
  

  steroids (prednisone and others);

  
  


• 
  

  seizure medicines (Dilantin and others);

  
  


• 
  

  some nonsteroidal anti-inflammatory drugs (NSAIDs); and

  
  


• 
  

  sulfa drugs (Bactrim, Gantanol, Gantrisin, Septra, SMX-TMP, and others).

  
  

These lists are not complete and other drugs may interact with pramlintide. 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 SymlinPen 60 resources

• SymlinPen 60 Side Effects (in more detail)
• SymlinPen 60 Use in Pregnancy & Breastfeeding
• SymlinPen 60 Drug Interactions
• SymlinPen 60 Support Group
• 0 Reviews for SymlinPen 60 - Add your own review/rating

• pramlintide Subcutaneous Advanced Consumer (Micromedex) - Includes Dosage Information


• Pramlintide MedFacts Consumer Leaflet (Wolters Kluwer)


• Pramlintide Acetate Monograph (AHFS DI)


• Symlin Prescribing Information (FDA)


• Symlin Vial MedFacts Consumer Leaflet (Wolters Kluwer)


• Symlin Consumer Overview

Compare SymlinPen 60 with other medications

• Diabetes, Type 1
• Diabetes, Type 2

Where can I get more information?

• Your pharmacist can provide more information about pramlintide.

See also: SymlinPen 60 side effects (in more detail)