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SymPak DM

30/06/10

Generic Name: Phenylephrine/Guaifenesin/Dextromethorphan (FEN-il-EF-rin/gwye-FEN-e-sin/DEX-troe-meth-OR-fan and KLOR-fen-IR-a-meen/FEN-il-EF-rin/METH-skoe-POL-a-meen)
Brand Name: SymPak DM

SymPak DM is used for:

Relieving nasal and chest congestion, sneezing, runny nose, and itchy, watery eyes due to colds, flu, or allergies. It is also used to reduce coughing and to make a dry cough more productive and less frequent. It may also be used for other conditions as determined by your doctor.

SymPak DM is a combination pack containing a morning dose and an evening dose. The morning dose has a decongestant, expectorant, and cough suppressant. The evening dose has an antihistamine, decongestant, and anticholinergic. The decongestant works by shrinking swollen tissue in the nose. The expectorant works by thinning mucus in the lungs. The cough suppressant works in the brain to reduce coughing. The antihistamine works by blocking histamine, a substance in the body that causes sneezing, runny nose, and watery eyes. The anticholinergic works by drying mucous membranes in the nose and chest.

Do NOT use SymPak DM if:

you are allergic to any ingredient in SymPak DM
you are pregnant or breast-feeding
you are taking droxidopa, furazolidone, sodium oxybate (GHB), or a monoamine oxidase inhibitor (MAOI) (eg, phenelzine), or if you have taken an MAOI within the past 14 days
you have severe heart blood vessel problems, severe high blood pressure, narrow-angle glaucoma, difficulty urinating due to enlarged prostate, peptic ulcer, or uncontrolled bleeding
you are having an asthma attack

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

Before using SymPak DM:

Some medical conditions may interact with SymPak DM. 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 bladder blockage, blood vessel problems (eg, hardening of the arteries), diabetes, an enlarged prostate, glaucoma or increased pressure in the eye, heart problems (eg, irregular heartbeat, heart failure), heart blood vessel problems, high blood pressure, inflammation of the esophagus from reflux disease, kidney problems, a hiatal hernia, an adrenal gland tumor (pheochromocytoma), myasthenia gravis (muscle weakness), stomach or bowel problems (eg, constipation, inflammation, motility problems, blockage), trouble sleeping, or an overactive thyroid
if you have chronic cough, chronic bronchitis, or any lung or breathing problems, such as asthma, emphysema, sleep apnea, or chronic obstructive pulmonary disease (COPD)
if you have a history of alcohol abuse
if you take potassium chloride tablets

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

Droxidopa or sodium oxybate (GHB ) because the risk of severe drowsiness, breathing problems, seizures, irregular heartbeat, or heart attack may be increased
Beta-blockers (eg, propranolol), catechol-O-methyltransferase (COMT) inhibitors (eg, tolcapone), furazolidone, MAOIs (eg, phenelzine), selective serotonin reuptake inhibitors (SSRIs) (eg, fluoxetine), or tricyclic antidepressants (eg, amitriptyline) because they may increase the risk of SymPak DM’s side effects
Bromocriptine because the risk of its side effects may be increased by SymPak DM
Guanadrel, guanethidine, mecamylamine, methyldopa, reserpine, or other medicine for high blood pressure because their effectiveness may be decreased by SymPak DM

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

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

Take SymPak DM by mouth with or without food.
Swallow SymPak DM whole. Do not break, crush, or chew before swallowing. Some brands of SymPak DM may be broken in half before taking. If you have difficulty swallowing the whole tablet, ask your pharmacist if your brand of medicine may be broken in half.
This product contains 2 different tablets; one for the morning and one for the evening. Be sure you understand how to take SymPak DM. Check with your doctor or pharmacist if you are not sure which tablet to take in the morning or in the evening.
If you miss a dose of SymPak DM and you are taking it regularly, take it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once.

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

Important safety information:

SymPak DM may cause drowsiness, dizziness, or blurred vision. These effects may be worse if you take it with alcohol or certain medicines. Use SymPak DM with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.
Do not drink alcohol or use medicines that may cause drowsiness (eg, sleep aids, muscle relaxers) while you are using SymPak DM; it may add to their effects. Ask your pharmacist if you have questions about which medicines may cause drowsiness.
The risk of dizziness, nervousness, and trouble sleeping may be greater if you take SymPak DM in high doses or for a long time. Do NOT take more than the recommended dose without checking with your doctor.
If your cough or other symptoms persist for more than 1 week, come back, or if you also have fever, rash, or persistent headache, check with your doctor.
SymPak DM may interfere with certain lab test results. Be sure your doctors and laboratory personnel know that you are taking SymPak DM.
Tell your doctor or dentist that you take SymPak DM before you receive any medical or dental care, emergency care, or surgery.
SymPak DM may cause dry mouth. To relieve dry mouth, suck on sugarless hard candy or ice chips, chew sugarless gum, drink water, or use a saliva substitute.
SymPak DM may reduce sweating. Do not become overheated in hot weather or during exercise or other activities because heatstroke may occur.
SymPak DM has phenylephrine, chlorpheniramine, and dextromethorphan in it. Before you start any new medicine, check the label to see if it has phenylephrine, chlorpheniramine, and dextromethorphan in it too. If it does or if you are not sure, check with your doctor or pharmacist.
Do not take diet or appetite control medicines while you are taking SymPak DM without checking with your doctor.
Diabetes patients – SymPak DM may affect your blood sugar. Check blood sugar levels closely and ask your doctor before adjusting the dose of your diabetes medicine.
Use SymPak DM with caution in the ELDERLY; they may be more sensitive to its effects.
SymPak DM should be used with extreme caution in CHILDREN younger than 6 years old; safety and effectiveness in these children have not been confirmed.
Caution is advised when using SymPak DM in CHILDREN; they may be more sensitive to its effects, especially excitability.
PREGNANCY and BREAST-FEEDING: It is not known if SymPak DM can cause harm to the fetus. If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using SymPak DM while you are pregnant. SymPak DM is found in breast milk. Do not breast-feed while taking SymPak DM.

Possible side effects of SymPak DM:

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:

Blurred vision; dizziness; drowsiness; dry mouth, nose, or throat; excitability or irritability (especially in children); giddiness; headache; lightheadedness; nausea; nervousness; trouble sleeping; unusual tiredness or weakness.

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

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); fast or irregular heartbeat; flushing; hallucinations; mental or mood changes; seizures severe drowsiness; tremor; vomiting.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. You may also report side effects at http://www.fda.gov/medwatch.

If OVERDOSE is suspected:

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

Proper storage of SymPak DM:

Store SymPak DM in a tightly closed container between 68 and 77 degrees F (20 and 25 degrees C). Store away from heat, moisture, and light. Do not store in the bathroom. Keep SymPak DM out of the reach of children and away from pets.

General information:

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

This information is a summary only. It does not contain all information about SymPak DM. 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: May 5, 2010

Database Edition 10.2.1.002

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Sympt-X

30/06/10

Generic Name: glutamine (Oral route)

GLOO-ta-meen

Commonly used brand name(s):

In the U.S.

Enterex Glutapak-10
Resource Glutasolve
Sympt-X
Sympt-X G.I.

Available Dosage Forms:

Powder for Solution
Powder for Suspension
Tablet
Capsule
Powder
Packet

Therapeutic Class: Amino Acid Supplement

Uses For Sympt-X

Glutamine is a substance naturally produced in the body to help regulate cell growth and function. There may also be man-made versions of these substances. Glutamine is used along with human growth hormone and a specialized diet to treat short bowel syndrome

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

Importance of Diet

For good health, it is important that you eat a balanced and varied diet. Follow carefully any diet program your health care professional may recommend. For your specific dietary vitamin and/or mineral needs, ask your health care professional for a list of appropriate foods. If you think that you are not getting enough vitamins and/or minerals in your diet, you may choose to take a dietary supplement.

Before Using Sympt-X

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:

In deciding to use glutamine, the risks of taking it must be weighed against the good it will do. This is a decision you and your doctor will make. For glutamine, 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 glutamine 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 glutamine in the elderly with use in other age groups. However, elderly patients are more likely to be sensitive requiring the need for dosage adjustment.

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. 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.

Proper Use of glutamine

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

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 form (powder for oral solution):
- For short bowel syndrome
  - Adults—30 grams per day in divided doses (5 grams taken 6 times a day) for up to 16 weeks. Taken with meals or snacks, 2 to 3 hours apart while awake.
  - Children—Use and dose must be determined by your doctor.

Missed Dose

If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage

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

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

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

Precautions While Using Sympt-X

It is very important that your doctor check you at regular visits.

Sympt-X 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

Blood in urine
changes in skin color
chills
cold hands and feet
confusion
cough
difficulty swallowing
dizziness
fainting
fast heartbeat
fever
frequent and painful urination
headache
hives
itching
lightheadedness
lower back or side pain
pain, redness, or swelling in arm or leg
puffiness or swelling of the eyelids or around the eyes, face, lips or tongue
rapid, shallow breathing
shortness of breath
skin rash
stomach pain
sudden decrease in amount of urine
tightness in chest
unusual tiredness or weakness
wheezing

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

Cough or hoarseness
frequent urge to defecate
straining while passing stool

Less common

Abnormal or decreased touch sensation
back pain
bacterial infection
bleeding after defecation
bleeding, blistering, burning, coldness, discoloration of skin, feeling of pressure, hives, infection, inflammation, itching, lumps, numbness, pain, rash, redness, scarring, soreness, stinging, swelling, tenderness, tingling, ulceration, or warmth at site
bloated full feeling
body aches or pain
breast pain, female
chest pain
change in the color, amount, or odor of vaginal discharge
congestion
constipation
Crohn’s disease, aggravated
dark urine
decreased urination
diarrhea
difficulty having a bowel movement (stool)
difficulty in moving
discoloration of fingernails or toenails
discouragement
dry mouth
dryness or soreness of throat
ear or hearing symptoms
excess air or gas in stomach or intestines
feeling sad or empty
feeling unusually cold shivering
flatulence
full or bloated feeling
general feeling of discomfort or illness
increase in heart rate
indigestion
irritability
joint pain;
lack of appetite
light-colored stools
loss of appetite
loss of interest or pleasure
muscle aches and pains
muscle pain or stiffness
nausea
pain in joints
pain or burning while urinating
pains in stomach, side, or abdomen, possibly radiating to the back
passing gas
pressure in the stomach
rash
rectal bleeding
runny nose
shivering
sleeplessness
sneezing
sore throat
stomach bloating, burning, cramping, or pain
stuffy nose
sunken eyes
sweating
swelling of abdominal or stomach area
swelling of face
swelling of hands, ankles, feet, or lower legs
swollen joints
tender, swollen glands in neck;
thirst
trouble concentrating
trouble sleeping
trouble in swallowing
unable to sleep
uncomfortable swelling around anus
unpleasant breath odor
unusual tiredness or weakness
voice changes
vomiting
vomiting of blood
weight loss
wrinkled skin
yellow eyes or skin

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

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

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

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

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SYMPT-X G.I.

30/06/10

Generic Name: glutamine (GLOO ta meen)
Brand Names: GlutaSolve, NutreStore, SYMPT-X G.I., SYMPT-X Glutamine

What is SYMPT-X G.I. (glutamine)?

Glutamine is an amino acid that affect the processes of growth and function of cells in the stomach and intestines.

Glutamine is a medical food product that is used to supplement dietary sources of glutamine, to treat a glutamine deficiency, or to treat a loss of glutamine caused by injury or illness.

Glutamine is also used in combination with human growth hormone to treat short bowel syndrome.

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

What is the most important information I should know about SYMPT-X G.I. (glutamine)?

Before you take glutamine, tell your doctor if you have liver or kidney disease.

The number of times per day you take glutamine depends on the reason you are using it. Always follow your doctor’s instructions.

Take glutamine oral powder with a meal or snack unless directed otherwise. Take glutamine tablets on an empty stomach, at least 1 hour before or 2 hours after a meal.

Follow your doctor’s instructions about any restrictions on food, beverages, or activity while you are using glutamine.

Do not pour dry glutamine powder directly into a tube feeding formula. Always mix the powder with water and infuse it directly into the feeding tube using a syringe.

Glutamine may be only part of a complete program of treatment that may also include a special diet, tube feedings, and IV fluids. It is very important to follow the diet and medication plan created for you by your doctor or nutrition counselor.

What should I discuss with my health care provider before taking SYMPT-X G.I. (glutamine)?

Before you take glutamine, tell your doctor if you have liver or kidney disease. You may need a dose adjustment or special tests to safely use this medication.

FDA pregnancy category C. It is not known whether glutamine is harmful to an unborn baby. Before taking this medication, tell your doctor if you are pregnant or plan to become pregnant during treatment. It is not known whether glutamine passes into breast milk or if it could harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby.

How should I take SYMPT-X G.I. (glutamine)?

Use this medication as directed on the label, or as your doctor has prescribed. Do not use the medication in larger amounts or for longer than recommended.

When treating short bowel syndrome, you may need to take glutamine 6 times per day for up to 16 weeks.

The number of times per day you take glutamine depends on the reason you are using it. Always follow your doctor’s instructions.

Take glutamine oral powder with a meal or snack unless directed otherwise. Take glutamine tablets on an empty stomach, at least 1 hour before or 2 hours after a meal. Dissolve your dose of glutamine oral powder in at least 8 ounces of hot or cold liquid. You may also mix the powder with a soft food such as pudding, applesauce, or yogurt. Stir this mixture and use all of it right away. Do not pour dry glutamine powder directly into a tube feeding formula. Always mix the powder with water and infuse it directly into the feeding tube using a syringe.

To be sure this medication is not causing harmful effects, your kidney and liver function may need to be checked with blood or urine tests on a regular basis. Do not miss any scheduled appointments.

Store glutamine at room temperature away from moisture and heat. Keep each dose of the oral powder in its packet until you are ready to use the medication.

What happens if I miss a dose?

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

What happens if I overdose?

An overdose of glutamine is not expected to produce life-threatening symptoms.

What should I avoid while taking SYMPT-X G.I. (glutamine)?

Follow your doctor’s instructions about any restrictions on food, beverages, or activity while you are using glutamine.

SYMPT-X G.I. (glutamine) 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:

chest pain;
hearing problems; or
signs of infection such as fever, chills, sore throat, flu symptoms, mouth sores, unusual weakness.

Less serious side effects may include:

nausea, vomiting, stomach pain, gas;
dry mouth, runny nose;
swelling in your hands or feet;
muscle or joint pain, back pain;
headache, dizziness, tired feeling;
mild skin rash or itching; or
increased sweating.

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 SYMPT-X G.I. (glutamine)?

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

Where can I get more information?

Your pharmacist can provide more information about glutamine.

Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.
Every effort has been made to ensure that the information provided by Cerner Multum, Inc. (‘Multum’) is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Multum’s drug information does not endorse drugs, diagnose patients or recommend therapy. Multum’s drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

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Symlin Pen

30/06/10

Generic Name: Pramlintide (PRAM-lin-tide)
Brand Name: Symlin Pen

Symlin Pen is used along with insulin. It may increase the risk of severe low blood sugar caused by insulin. The risk may be higher in patients with type 1 diabetes. If this occurs, it is seen within 3 hours after an injection of Symlin Pen. Use caution if you will be driving or performing other possibly unsafe tasks. Be sure you understand how to use Symlin Pen and how to recognize low blood sugar. Discuss any questions or concerns with your health care provider.

Symlin Pen is used for:

Treating diabetes in certain patients who also use insulin.

Symlin Pen is an amylin analog. It works by slowing down food digestion. This prevents blood sugar from rising as quickly after you eat. It may also help you feel full faster.

Do NOT use Symlin Pen if:

you are allergic to any ingredient in Symlin Pen, including metacresol
you have a condition that causes your stomach to empty very slowly (gastroparesis)
you cannot tell when your blood sugar is low
you take an alpha glucosidase inhibitor (eg, acarbose) or an anticholinergic (eg, scopolamine, hyoscyamine)

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

Before using Symlin Pen:

Some medical conditions may interact with Symlin Pen. 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 vision or coordination problems, or a history of stomach or bowel problems
if you have had severe low blood sugar within the past 6 months, have diabetic nerve disease (eg, peripheral neuropathy), or have high hemoglobin A_1c
if you have trouble using your insulin therapy or monitoring your blood sugar levels
if you are on dialysis
if you take medicine that helps food move through your stomach more quickly

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

Beta blockers (eg, propranolol), clonidine, guanethidine, or reserpine because they may hide the symptoms of low blood sugar
Angiotensin-converting enzyme (ACE) inhibitors (eg, enalapril), disopyramide, fibrates (eg, clofibrate), fluoxetine, monoamine oxidase inhibitors (MAOIs) (eg, phenelzine), pentoxifylline, propoxyphene, salicylates (eg, aspirin), sulfonamide antibiotics (eg, sulfamethoxazole), or sulfonylureas (eg, glipizide) because the risk of low blood sugar may be increased
Alpha glucosidase inhibitors (eg, acarbose) or anticholinergics (eg, scopolamine, hyoscyamine) because they may increase the risk of Symlin Pen’s side effects

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

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

Symlin Pen comes with an extra patient information sheet called a Medication Guide. It also comes with a “Patient Instructions for Use” sheet. Read these information sheets carefully before you use Symlin Pen. Read them again each time you get Symlin Pen refilled.
Use Symlin Pen immediately before major meals, as directed by your health care provider.
A health care provider will teach you how to use Symlin Pen. Be sure you understand how to use it. Follow the procedures you are taught when you use a dose. Contact your health care provider if you have any questions.
Be sure you understand how to use the pen-injector. Be sure to check the dosing window before each injection to make sure you receive the correct amount of medicine. Ask your doctor or other health care provider any questions that you may have about Symlin Pen or about using the pen-injector.
Do not use Symlin Pen if it contains particles, is cloudy or discolored, or if the container is cracked or damaged.
Symlin Pen is given as an injection under the skin, usually in the stomach area or upper thigh. Do not inject Symlin Pen into the arm, because it may not absorb properly. Rotate injection sites so you do not use the same site repeatedly.
Do not transfer medicine from the pen-injector into a syringe. This may cause you to receive too much medicine per dose and may increase your risk of serious side effects.
Do not mix Symlin Pen with insulin or inject it in the same area as insulin. Inject Symlin Pen at least 2 inches away from where you inject your insulin.
If you store Symlin Pen in the refrigerator, allow it to warm to room temperature before you inject a dose. This may decrease the chance of a reaction at the injection site.
Symlin Pen may affect the way other medicines are absorbed into your body. Some medicines may need to be taken at least 1 hour before or 2 hours after using Symlin Pen. Talk with your doctor or pharmacist about how you should take any other medicines with Symlin Pen.
Keep this product, as well as syringes and needles, out of the reach of children and pets. Do not reuse needles, syringes, or other materials. Ask your health care provider how to dispose of these materials after use. Follow all local rules for disposal.
Continue to use Symlin Pen even if you feel well. Do not miss any doses.
If you miss a dose of Symlin Pen, 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 Symlin Pen.

Important safety information:

Dizziness may occur while you are using Symlin Pen. This effect may be worse if you take it with alcohol or certain medicines. Use Symlin Pen with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.
Do not drink alcohol without discussing it with your doctor. Drinking alcohol may increase the risk of developing low blood sugar.
Nausea is a common side effect of Symlin Pen. Mild nausea is more likely during the first weeks of treatment and usually does not last long. Tell your doctor if nausea continues or is bothersome.
Do NOT use Symlin Pen if your blood sugar is too low, you skip a meal, you plan to eat a meal with fewer than 250 calories or 30 grams of carbohydrates, you are sick and cannot eat your usual meal, you are having surgery or a medical test in which you cannot eat, or you are pregnant or breast-feeding and have not talked to your doctor.
Do not use more than your prescribed dose of Symlin Pen without checking with your doctor. Using more than the prescribed dose may cause nausea and vomiting, and you may not be able to eat the amount of food you usually eat. If you use more of Symlin Pen than the prescribed dose, pay close attention to the amount of insulin use. You may have greater risk of developing low blood sugar. Contact your doctor or other health care provider for instructions.
Tell your doctor or dentist that you take Symlin Pen before you receive any medical or dental care, emergency care, or surgery.
Talk with your health care provider about all of your diabetes medicines and how to use them. Do not start, stop, or change the dose of any diabetes medicine unless your doctor tells you to.
If you stop using Symlin Pen for any reason (eg, surgery, illness), contact your doctor. Follow your doctor’s instructions for restarting Symlin Pen.
Symlin Pen may increase the risk of severe low blood sugar caused by insulin. Low blood sugar may also occur if you use too much of Symlin Pen, use too much insulin, skip a meal, or exercise more than usual. Low blood sugar may make you anxious, sweaty, weak, dizzy, drowsy, or faint. It may also make your heart beat faster; make your vision change; give you a headache, chills, or tremors; or make you more hungry. It is a good idea to carry a reliable source of glucose (eg, tablets or gel) to treat low blood sugar. If this is not available, you should eat or drink a quick source of sugar like table sugar, honey, candy, orange juice, or non-diet soda. This will raise your blood sugar level quickly. Tell your doctor right away if this happens. To prevent low blood sugar, eat meals at the same time each day and do not skip meals.
Carry an ID card at all times that says you take Symlin Pen.
Monitor your blood sugar levels as directed by your health care provider. Most patients will monitor blood sugar before meals, after meals, and at bedtime. If your blood sugar is often higher or lower than it should be, check with your doctor.
Follow the diet and exercise program given to you by your health care provider.
Ask your health care provider what you should do if you miss a dose of your insulin.
It may be harder to control your blood sugar during times of stress such as fever, infection, injury, or surgery. If any of these occur, talk with your doctor. A change in your medicine may be needed.
Lab tests, including fasting blood sugar levels and hemoglobin A_1c, may be performed while you use Symlin Pen. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.
Symlin Pen should not be used in CHILDREN; safety and effectiveness have not been confirmed.
PREGNANCY and BREAST-FEEDING: If you become pregnant while taking Symlin Pen, contact your doctor. You will need to discuss the benefits and risks of using Symlin Pen while you are pregnant. It is not known if Symlin Pen is found in breast milk. If you are or will be breast-feeding while you are using Symlin Pen, check with your doctor. Discuss any possible risks to your baby.

Possible side effects of Symlin Pen:

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:

Decreased appetite; indigestion; minor redness, swelling, itching, or pain at the injection site; nausea; stomach pain; tiredness; vomiting.

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

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); seizure; severe of persistent nausea; symptoms of low blood sugar (eg, chills, dizziness, drowsiness, fainting, fast heartbeat, headache, increased hunger, irritability, nervousness, sweating, tremor, trouble concentrating, weakness).

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center (http://www.aapcc.org), or emergency room immediately. Symptoms may include diarrhea; dizziness; flushing; severe nausea; vomiting.

Proper storage of Symlin Pen:

Store new (unused) pen-injectors in the refrigerator, between 36 and 46 degrees F (2 and 8 degrees C). Do not freeze. Store opened (used) pen-injectors in the refrigerator or at room temperature, up to 86 degrees F (30 degrees C). Store away from heat, moisture, and light. Do not store in the bathroom. Throw away used pen-injectors after 30 days, even if they still contain medicine. Do not use Symlin Pen if it has been frozen or heated above room temperature, or if it is expired. Keep Symlin Pen out of the reach of children and away from pets.

General information:

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

This information is a summary only. It does not contain all information about Symlin Pen. 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: May 5, 2010

Database Edition 10.2.1.002

Med-facts,S

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SymlinPen

30/06/10

Generic Name: pramlintide (Subcutaneous route)

PRAM-lin-tide

Subcutaneous routeSolution

Pramlintide acetate is used with insulin and has been associated with an increased risk of insulin-induced severe hypoglycemia, particularly in patients with type 1 diabetes. When severe hypoglycemia associated with pramlintide acetate use occurs, it is seen within 3 hours following a pramlintide acetate injection. If severe hypoglycemia occurs while operating a motor vehicle, heavy machinery, or while engaging in other high-risk activities, serious injuries may occur. Appropriate patient selection, careful patient instruction, and insulin dose adjustments are critical elements for reducing this risk .

Pramlintide acetate is used with insulin and has been associated with an increased risk of insulin-induced severe hypoglycemia. When severe hypoglycemia associated with pramlintide acetate use occurs, it is seen within 3 hours following a pramlintide acetate injection. Appropriate patient selection, careful patient instruction, and insulin dose adjustments are critical elements for reducing this risk .

Commonly used brand name(s):

In the U.S.

Symlin
SymlinPen

Available Dosage Forms:

Solution

Therapeutic Class: Antidiabetic

Uses For SymlinPen

Pramlintide is used to treat high blood sugar in patients with type 1 and type 2 diabetes. This medicine will decrease the time it takes for food to move through the stomach. It also works to prevent the liver from making sugar. Pramlintide is always used together with insulin to lower the high blood sugar that occurs after meals.

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

Before Using SymlinPen

Allergies

Pediatric

Appropriate studies have not been performed on the relationship of age to the effects of pramlintide in the pediatric population. Safety and efficacy have not been established.

Geriatric

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

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

Interactions with Medicines

Interactions with Food/Tobacco/Alcohol

Proper Use of pramlintide

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

When you start using this medicine, it is very important that you check your blood sugar often, especially before and after meals and at bedtime. This will help lower the chance of having very low blood sugar.

This medicine should come with a medication guide and patient information insert. Read and follow these instructions carefully. Ask your doctor if you have any questions.

You will be using pramlintide at home. Your doctor will teach you how the injections are to be given. Be sure you understand exactly how the medicine is to be injected. Tell your doctor if you have dexterity (skill in using the hands) or vision problems.

This medicine is available in 2 forms. You may use a vial or a SymlinPen™ pen-injector. Your doctor will tell you which dosage form is right for you.

You should never mix your insulin and pramlintide injections together. These injections are always given separately. Also, this medicine should not be used in an insulin infusion pump. If you have questions about this, ask your doctor or pharmacist.

This medicine is given as a shot under the skin of your stomach or upper thigh. Inject pramlintide at a site that is more than 2 inches away from your insulin injection. Never inject insulin and pramlintide in the same site.

Allow the medicine to warm at room temperature before you inject it. If the medicine in the vial or pen-injector has changed color, looks cloudy, or if you see particles in it, do not use it.

Use a new needle and syringe each time you inject your medicine.

Throw away used needles and syringes in a hard, closed container that the needles cannot poke through (puncture-resistant). Keep this container away from children and pets.

Carefully follow the special meal plan your doctor gave you. This is the most important part of controlling your diabetes, and is necessary for the medicine to work properly. Also, exercise regularly and test for sugar in your blood or urine as directed.

Dosing

For injection dosage form:
- For Type 1 diabetes:
  - Adults—The dose is based on your blood sugar and how well your body adjusts to the medicine. This must be determined by your doctor. The starting dose is 15 micrograms (mcg) injected under the skin right before major meals. A major meal has at least 250 calories or 30 grams of carbohydrates. Your doctor may adjust your dose as needed.
  - Children—Use and dose must be determined by your doctor.
- For Type 2 diabetes:
  - Adults—The dose is based on your blood sugar and how well your body adjusts to the medicine. This must be determined by your doctor. The starting dose is 60 micrograms (mcg) injected under the skin right before major meals. A major meal has at least 250 calories or 30 grams of carbohydrates. Your doctor may adjust your dose as needed.
  - Children—Use and dose must be determined by your doctor.

Missed Dose

If you miss a dose of this medicine, 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 in the refrigerator. Do not freeze.

Store the unopened vial or pen-injector in the refrigerator until you are ready to use it. Protect the vial or pen-injector from bright light.

A vial or pen-injector that has been used may be kept in the refrigerator or at room temperature for up to 30 days. Throw away any medicine that has not been used after 30 days.

Precautions While Using SymlinPen

It is very important that your doctor check your progress at regular visits, especially during the first few weeks you receive this medicine. Blood tests may be needed to see how well you have adjusted to the medicine.

It is very important to follow carefully any instructions from your health care team about:

Alcohol—Drinking alcohol (including beer and wine) may cause severe low blood sugar. Discuss this with your health care team.
Other medicines—Do not take other medicines unless they have been discussed with your doctor. This especially includes nonprescription medicines such as aspirin, and medicines for appetite control, asthma, colds, cough, hay fever, or sinus problems.
Counseling—Other family members need to learn how to prevent side effects or help with side effects if they occur. Also, patients with diabetes, especially teenagers, may need special counseling about pramlintide dosing changes that might occur because of lifestyle changes, such as changes in exercise and diet. Furthermore, counseling on contraception and pregnancy may be needed because of the problems that can occur in women with diabetes who become pregnant.
Travel—Keep a recent prescription and your medical history with you. Be prepared for an emergency as you would normally. Make allowances for changing time zones and keep your meal times as close as possible to your usual meal times, and store pramlintide properly.

In case of emergency—There may be a time when you need emergency help for a problem caused by your diabetes. You need to be prepared for these emergencies. It is a good idea to:

Wear a medical identification (ID) bracelet or neck chain at all times. Also, carry an ID card in your wallet or purse that says that you have diabetes and lists all of your medicines.
Keep an extra supply of insulin and syringes with needles on hand in case high blood sugar occurs.
Keep some kind of quick-acting sugar handy to treat low blood sugar.
Have a glucagon kit available in case severe low blood sugar occurs. Check and replace any expired kits regularly.

When used together with insulin, pramlintide may cause low blood sugar (also called hypoglycemia or insulin reaction), especially in patients with type 1 diabetes. Symptoms of low blood sugar must be treated before they lead to unconsciousness (passing out). Different people may feel different symptoms of low blood sugar. It is important that you learn what symptoms of low blood sugar you usually have so that you can treat it quickly.

Symptoms of low blood sugar can include: anxious feeling, behavior change similar to being drunk, blurred vision, cold sweats, confusion, cool pale skin, difficulty in concentrating, drowsiness, excessive hunger, fast heartbeat, headache, nausea, nervousness, nightmares, restless sleep, shakiness, slurred speech, and unusual tiredness or weakness.
The symptoms of low blood sugar may develop quickly and result from:
- delaying or missing a scheduled meal or snack.
- exercising more than usual.
- drinking a significant amount of alcohol.
- taking certain medicines.
- using too much insulin.
- sickness (especially with vomiting or diarrhea).
Know what to do if symptoms of low blood sugar occur. Eating some form of quick-acting sugar when symptoms of low blood sugar first appear will usually prevent them from getting worse. Good sources of sugar include:
- Glucose tablets or gel, fruit juice or nondiet soft drink (4 to 6 ounces [one-half cup]), corn syrup or honey (1 tablespoon), sugar cubes (six one-half inch size), or table sugar (dissolved in water).
  - If a snack is not scheduled for an hour or more you should also eat a light snack, such as cheese and crackers, half a sandwich, or drink an 8-ounce glass of milk.
  - Do not use chocolate because the fat slows down the sugar getting into the blood.
- Glucagon is used in emergency situations such as unconsciousness. Have a glucagon kit available and know how to prepare and use it. Members of your household also should know how and when to use it.

High blood sugar (hyperglycemia) is another problem related to uncontrolled diabetes. If you have any symptoms of high blood sugar, contact your health care team right away. If high blood sugar is not treated, severe hyperglycemia can occur, leading to ketoacidosis (diabetic coma) and death.

The symptoms of mild high blood sugar appear more slowly than those of low blood sugar. Symptoms can include: blurred vision; drowsiness; dry mouth; flushed and dry skin; fruit-like breath odor; increased urination (frequency and volume); loss of appetite; stomachache, nausea, or vomiting; tiredness; troubled breathing (rapid and deep); and unusual thirst.
Symptoms of severe high blood sugar (called ketoacidosis or diabetic coma) that need immediate hospitalization include: flushed and dry skin, fruit-like breath odor, ketones in urine, passing out, and troubled breathing (rapid and deep).
High blood sugar symptoms may occur if you:
- have diarrhea, a fever, or an infection.
- do not take enough insulin or skip a dose of insulin.
- do not exercise as much as usual.
- overeat or do not follow your meal plan.
Know what to do if high blood sugar occurs. Your doctor may recommend changes in your pramlintide and/or insulin dose or meal plan to avoid high blood sugar. Symptoms of high blood sugar must be corrected before they progress to more serious conditions. Check with your doctor often to make sure you are controlling your blood sugar. Your doctor might discuss the following with you:
- Increasing your insulin dose when you plan to eat an unusually large dinner, such as on holidays. This type of increase is called an anticipatory dose.
- Decreasing your dose for a short time for special needs, such as when you cannot exercise as you normally do. Changing only one type of insulin dose (usually the first dose) and anticipating how the change may affect other doses during the day. Contacting your doctor if you need a permanent change in dose.
- Delaying a meal if your blood glucose is over 200 mg/dL to allow time for your blood sugar to go down. An extra insulin dose may be needed if your blood sugar does not come down shortly.
- Not exercising if your blood glucose is over 240 mg/dL and reporting this to your doctor immediately.
- Being hospitalized if ketoacidosis or diabetic coma occurs.

You may have some skin redness, swelling, or itching at the injection site. If this irritation is severe or does not go away, call your doctor.

SymlinPen Side Effects

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

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

More common

Anxiety
blurred vision
chills
cold sweats
coma
confusion
cool pale skin
cough
depression
difficulty swallowing
dizziness
fast heartbeat
headache
hives
increased hunger
itching
nausea
nervousness
nightmares
puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
seizures
shakiness
shortness of breath
skin rash
slurred speech
tightness in the chest
unusual tiredness or weakness
wheezing

More common

Difficulty with moving
inflicted injury
loss of appetite
muscle pain or stiffness
pain in the joints
stomach pain
vomiting
weight loss

Less common

Body aches or pain
congestion
dryness or soreness of the throat
fever
hoarseness
runny nose
tender, swollen glands in the neck
trouble in swallowing
voice changes

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.

Advanced,S

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SymlinPen 120

30/06/10

Generic Name: pramlintide (PRAM lin tide)
Brand Names: Symlin, SymlinPen 120, SymlinPen 60

What is SymlinPen 120 (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 120 (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 120 (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 120 (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 120 (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 120 (pramlintide) 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 120 (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.

Where can I get more information?

Your pharmacist can provide more information about pramlintide.

Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.
Every effort has been made to ensure that the information provided by Cerner Multum, Inc. (‘Multum’) is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Multum’s drug information does not endorse drugs, diagnose patients or recommend therapy. Multum’s drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

Concise,S

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SymlinPen 60

30/06/10

Generic Name: pramlintide (PRAM lin tide)
Brand Names: Symlin, SymlinPen 120, SymlinPen 60

What is SymlinPen 60 (pramlintide)?

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.

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.

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

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;

How should I use SymlinPen 60 (pramlintide)?

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.

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 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?

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

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).

Where can I get more information?

Your pharmacist can provide more information about pramlintide.

Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.
Every effort has been made to ensure that the information provided by Cerner Multum, Inc. (‘Multum’) is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Multum’s drug information does not endorse drugs, diagnose patients or recommend therapy. Multum’s drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

Concise,S

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Symmetrel

30/06/10

Generic Name: amantadine (a MAN ta deen)
Brand Names: Symmetrel

What is Symmetrel (amantadine)?

Amantadine is an antiviral medication. It blocks the actions of viruses in your body.

Amantadine is used to treat and to prevent influenza A (a viral infection). There may be some flu seasons during which amantadine is not recommended because certain flu strains may be resistant to this drug.

Amantadine is also used to treat Parkinson’s disease and “Parkinson-like” symptoms such as stiffness and shaking that may be caused by the use of certain drugs.

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

What is the most important information I should know about Symmetrel (amantadine)?

Before taking amantadine, tell your doctor if you have epilepsy or other seizure disorder, congestive heart failure, kidney or liver disease, low blood pressure, eczema, glaucoma, or a history of mental illness, suicide attempt, or drug/alcohol addiction.

Amantadine can cause side effects that may impair your thinking, vision, or reactions. Be careful if you drive or do anything that requires you to be alert and able to see clearly. If you are taking amantadine to treat influenza A, take the medication for the entire length of time prescribed by your doctor. Your symptoms may get better before the infection is completely treated. If you are taking amantadine to treat Parkinson symptoms, do not stop taking the medication without first talking to your doctor. If you stop taking amantadine suddenly, your condition may become worse.

You may have increased sexual urges, unusual urges to gamble, or other intense urges while taking this medication. Talk with your doctor if you believe you have any intense or unusual urges while taking amantadine.

What should I discuss with my healthcare provider before taking Symmetrel (amantadine)?

You should not use this medication if you are allergic to amantadine, or if you have received a nasal flu vaccine (FluMist) within the past 14 days.

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

epilepsy or other seizure disorder;
congestive heart failure;
kidney disease;
liver disease;
low blood pressure or fainting;
eczema;
glaucoma; or
a history of mental illness, suicide attempt, or drug/alcohol addiction.

You may have increased sexual urges, unusual urges to gamble, or other intense urges while taking amantadine. It is not known whether the medicine actually causes this effect. Talk with your doctor if you believe you have any intense or unusual urges while taking amantadine.

Some people taking medicines for Parkinson’s disease have developed skin cancer (melanoma). However, people with Parkinson’s disease may have a higher risk than most people for developing melanoma. Talk to your doctor about your specific risk and what skin symptoms to watch for. You may need to have regular skin exams.

FDA pregnancy category C. It is not known whether this medication is harmful to an unborn baby. Before taking amantadine, tell your doctor if you are pregnant or plan to become pregnant during treatment. Amantadine 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 Symmetrel (amantadine)?

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 this medicine with a full glass of water.

Measure the liquid form of amantadine with a special dose-measuring spoon or cup, not a regular table spoon. If you do not have a dose-measuring device, ask your pharmacist for one.

If you are taking amantadine to treat influenza A, start taking the medication within 24 to 48 hours after flu symptoms begin. Keep taking the medication for the entire length of time prescribed by your doctor. Your symptoms may get better before the infection is completely treated. If you are taking amantadine to treat Parkinson symptoms, do not stop taking the medication without first talking to your doctor. If you stop taking amantadine suddenly, your condition may become worse. Store amantadine at room temperature away from moisture and heat.

What happens if I miss a dose?

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

What happens if I overdose?

Seek emergency medical attention if you think you have used too much of this medicine. An overdose of amantadine can be fatal.

Overdose symptoms may include fever, anxiety, severe headache, confusion, hallucinations, agitation, aggression, personality changes, tremor, problems with balance or walking, fast or uneven heart rate, urinating less than usual or not at all, trouble breathing, seizure (convulsion), or fainting.

What should I avoid while taking Symmetrel (amantadine)?

Do not use FluMist nasal influenza “live vaccine” while you are being treated with amantadine and for at least 48 hours after you stop taking amantadine. The nasal vaccine may not be as effective if you receive it while you are taking amantadine. Before taking amantadine, tell your doctor if you have received a nasal flu vaccine within the past 14 days. Amantadine can cause side effects that may impair your vision, thinking, or reactions. Be careful if you drive or do anything that requires you to be alert and able to see clearly.

Avoid getting up too fast from a sitting or lying position, or you may feel dizzy. Get up slowly and steady yourself to prevent a fall.

Avoid drinking alcohol. It can increase some of the side effects of amantadine.

Avoid taking diet pills, caffeine pills, or other stimulants (such as ADHD medications) without your doctor’s advice. Taking a stimulant together with amantadine can increase your risk of unpleasant side effects.

Symmetrel (amantadine) side effects

feeling short of breath, even with mild exertion;
swelling, rapid weight gain;
feeling depressed, agitated, or aggressive;
behavior changes, hallucinations, thoughts of hurting yourself;
urinating less than usual or not at all;
high fever, stiff muscles, confusion, sweating, fast or uneven heartbeats, rapid breathing, feeling like you might pass out;
restless muscle movements in your eyes, tongue, jaw, or neck; or
tremor (uncontrolled shaking).

Less serious side effects may include:

dizziness, drowsiness, headache;
sleep problems (insomnia), strange dreams;
feeling nervous;
nausea, diarrhea, constipation, loss of appetite;
dry mouth, dry nose; or
loss of balance or coordination.

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 Symmetrel (amantadine)?

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

atropine (Atreza, Sal-Tropine, and others);
dicyclomine (Bentyl);
glycopyrrolate (Robinul);
hyoscyamine (Anaspaz, Levbid, Levsin, Nulev, and others);
mepenzolate (Cantil);
methscopolamine (Pamine);
propantheline (Pro-Banthine);
scopolamine (Maldemar, Scopace, Transderm-Scop).
quinine (Qualaquin);
quinidine (Cardioquin, Quinaglute);
a diuretic (water pill) such as triamterene (Dyrenium), hydrochlorothiazide (HCTZ, Dyazide, HydroDiuril, Hyzaar, Lopressor, Vasoretic, Zestoretic), and others; or
phenothiazines such as prochlorperazine (Compazine), thioridazine (Mellaril), and others.

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

Where can I get more information?

Your pharmacist can provide more information about amantadine.

Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed
Every effort has been made to ensure that the information provided by Cerner Multum, Inc. (‘Multum’) is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Multum’s drug information does not endorse drugs, diagnose patients or recommend therapy. Multum’s drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

Concise,S

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Symlin

30/06/10

Generic Name: pramlintide (PRAM lin tide)
Brand Names: Symlin, SymlinPen 120, SymlinPen 60

What is pramlintide?

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 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.

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.

What should I discuss with my doctor before using pramlintide?

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;

How should I use pramlintide?

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.

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 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?

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 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.

Pramlintide 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 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).

Where can I get more information?

Your pharmacist can provide more information about pramlintide.

Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.
Every effort has been made to ensure that the information provided by Cerner Multum, Inc. (‘Multum’) is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Multum’s drug information does not endorse drugs, diagnose patients or recommend therapy. Multum’s drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

Concise,S

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Symlin Vial

30/06/10

Generic Name: Pramlintide (PRAM-lin-tide)
Brand Name: Symlin

Symlin Vial is used along with insulin. It may increase the risk of severe low blood sugar caused by insulin. The risk may be higher in patients with type 1 diabetes. If this occurs, it is seen within 3 hours after an injection of Symlin Vial. Use caution if you will be driving or performing other possibly unsafe tasks. Be sure you understand how to use Symlin Vial and how to recognize low blood sugar. Discuss any questions or concerns with your health care provider.

Symlin Vial is used for:

Treating diabetes in certain patients who also use insulin.

Symlin Vial is an amylin analog. It works by slowing down food digestion. This prevents blood sugar from rising as quickly after you eat. It may also help you feel full faster.

Do NOT use Symlin Vial if:

you are allergic to any ingredient in Symlin Vial, including metacresol
you have a condition that causes your stomach to empty very slowly (gastroparesis)
you cannot tell when your blood sugar is low
you take an alpha glucosidase inhibitor (eg, acarbose) or an anticholinergic (eg, scopolamine, hyoscyamine)

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

Before using Symlin Vial:

Some medical conditions may interact with Symlin Vial. 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 vision or coordination problems, or a history of stomach or bowel problems
if you have had severe low blood sugar within the past 6 months, have diabetic nerve disease (eg, peripheral neuropathy), or have high hemoglobin A_1c
if you have trouble using your insulin therapy or monitoring your blood sugar levels
if you are on dialysis
if you take medicine that helps food move through your stomach more quickly

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

Beta blockers (eg, propranolol), clonidine, guanethidine, or reserpine because they may hide the symptoms of low blood sugar
Angiotensin-converting enzyme (ACE) inhibitors (eg, enalapril), disopyramide, fibrates (eg, clofibrate), fluoxetine, monoamine oxidase inhibitors (MAOIs) (eg, phenelzine), pentoxifylline, propoxyphene, salicylates (eg, aspirin), sulfonamide antibiotics (eg, sulfamethoxazole), or sulfonylureas (eg, glipizide) because the risk of low blood sugar may be increased
Alpha glucosidase inhibitors (eg, acarbose) or anticholinergics (eg, scopolamine, hyoscyamine) because they may increase the risk of Symlin Vial’s side effects

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

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

Symlin Vial comes with an extra patient information sheet called a Medication Guide. It also comes with a “Patient Instructions for Use” sheet. Read these information sheets carefully before you use Symlin Vial. Read them again each time you get Symlin Vial refilled.
Use Symlin Vial immediately before major meals, as directed by your health care provider.
A health care provider will teach you how to use Symlin Vial. Be sure you understand how to use it. Follow the procedures you are taught when you use a dose. Contact your health care provider if you have any questions.
Do not use Symlin Vial if it contains particles, is cloudy or discolored, or if the vial is cracked or damaged.
Symlin Vial is given as an injection under the skin, usually in the stomach area or upper thigh. Do not inject Symlin Vial into the arm, because it may not absorb properly. Rotate injection sites so you do not use the same site repeatedly.
Do not mix Symlin Vial in the same syringe with insulin or inject it in the same area as insulin. Inject Symlin Vial at least 2 inches away from where you inject your insulin.
If you store Symlin Vial in the refrigerator, allow it to warm to room temperature before you inject a dose. This may decrease the chance of a reaction at the injection site.
Symlin Vial may affect the way other medicines are absorbed into your body. Some medicines may need to be taken at least 1 hour before or 2 hours after using Symlin Vial. Talk with your doctor or pharmacist about how you should take any other medicines with Symlin Vial.
Keep this product, as well as syringes and needles, out of the reach of children and pets. Do not reuse needles, syringes, or other materials. Ask your health care provider how to dispose of these materials after use. Follow all local rules for disposal.
Continue to use Symlin Vial even if you feel well. Do not miss any doses.
If you miss a dose of Symlin Vial, 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 Symlin Vial.

Important safety information:

Dizziness may occur while you are using Symlin Vial. This effect may be worse if you take it with alcohol or certain medicines. Use Symlin Vial with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.
Do not drink alcohol without discussing it with your doctor. Drinking alcohol may increase the risk of developing low blood sugar.
Nausea is a common side effect of Symlin Vial. Mild nausea is more likely during the first weeks of treatment and usually does not last long. Tell your doctor if nausea continues or is bothersome.
Do NOT use Symlin Vial if your blood sugar is too low, you skip a meal, you plan to eat a meal with fewer than 250 calories or 30 grams of carbohydrates, you are sick and cannot eat your usual meal, you are having surgery or a medical test for which you cannot eat, or you are pregnant or breast-feeding and have not talked to your doctor.
Do not use more than your prescribed dose of Symlin Vial without checking with your doctor. Using more than the prescribed dose may cause nausea and vomiting, and you may not be able to eat the amount of food you usually eat. If you use more of Symlin Vial than the prescribed dose, pay close attention to the amount of insulin use. You may have greater risk of developing low blood sugar. Contact your doctor or other health care provider for instructions.
Tell your doctor or dentist that you take Symlin Vial before you receive any medical or dental care, emergency care, or surgery.
Talk with your health care provider about all of your diabetes medicines and how to use them. Do not start, stop, or change the dose of any diabetes medicine unless your doctor tells you to.
If you stop using Symlin Vial for any reason (eg, surgery, illness), contact your doctor. Follow your doctor’s instructions for restarting Symlin Vial.
Symlin Vial may increase the risk of severe low blood sugar caused by insulin. Low blood sugar may also occur if you use too much of Symlin Vial, use too much insulin, skip a meal, or exercise more than usual. Low blood sugar may make you anxious, sweaty, weak, dizzy, drowsy, or faint. It may also make your heart beat faster; make your vision change; give you a headache, chills, or tremors; or make you more hungry. It is a good idea to carry a reliable source of glucose (eg, tablets or gel) to treat low blood sugar. If this is not available, you should eat or drink a quick source of sugar like table sugar, honey, candy, orange juice, or non-diet soda. This will raise your blood sugar level quickly. Tell your doctor right away if this happens. To prevent low blood sugar, eat meals at the same time each day and do not skip meals.
Carry an ID card at all times that says you take Symlin Vial.
Monitor your blood sugar levels as directed by your health care provider. Most patients will monitor blood sugar before meals, after meals, and at bedtime. If your blood sugar is often higher or lower than it should be, check with your doctor.
Follow the diet and exercise program given to you by your health care provider.
Ask your health care provider what you should do if you miss a dose of your insulin.
It may be harder to control your blood sugar during times of stress such as fever, infection, injury, or surgery. If any of these occur, talk with your doctor. A change in your medicine may be needed.
Lab tests, including fasting blood sugar levels and hemoglobin A_1c, may be performed while you use Symlin Vial. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.
Symlin Vial should not be used in CHILDREN; safety and effectiveness have not been confirmed.
PREGNANCY and BREAST-FEEDING: If you become pregnant while taking Symlin Vial, contact your doctor. You will need to discuss the benefits and risks of using Symlin Vial while you are pregnant. It is not known if Symlin Vial is found in breast milk. If you are or will be breast-feeding while you are using Symlin Vial, check with your doctor. Discuss any possible risks to your baby.

Possible side effects of Symlin Vial:

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:

Decreased appetite; indigestion; minor redness, swelling, itching, or pain at the injection site; nausea; stomach pain; tiredness; vomiting.

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

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); seizure; severe of persistent nausea; symptoms of low blood sugar (eg, chills, dizziness, drowsiness, fainting, fast heartbeat, headache, increased hunger, irritability, nervousness, sweating, tremor, trouble concentrating, weakness).

If OVERDOSE is suspected:

Proper storage of Symlin Vial:

Store new (unused) vials in the refrigerator, between 36 and 46 degrees F (2 and 8 degrees C). Do not freeze. Store opened (used) vials in the refrigerator or at room temperature, up to 86 degrees F (30 degrees C). Store away from heat, moisture, and light. Do not store in the bathroom. Throw away used vials after 30 days, even if they still contain medicine. Do not use Symlin Vial if it has been frozen or heated above room temperature, or if it is expired. Keep Symlin Vial out of the reach of children and away from pets.

General information:

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

This information is a summary only. It does not contain all information about Symlin Vial. 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: May 5, 2010

Database Edition 10.2.1.002

Med-facts,S

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Drugs & Medications:A-Z

Recent Posts

Blogroll

30/06/10

SymPak DM is used for:

Do NOT use SymPak DM if:

Before using SymPak DM:

How to use SymPak DM:

Important safety information:

Possible side effects of SymPak DM:

If OVERDOSE is suspected:

General information:

30/06/10

Uses For Sympt-X

Importance of Diet

Before Using Sympt-X

Allergies

Pediatric

Geriatric

Pregnancy

Breast Feeding

Interactions with Medicines

Interactions with Food/Tobacco/Alcohol

Other Medical Problems

Proper Use of glutamine

Dosing

Missed Dose

Storage

Precautions While Using Sympt-X

Sympt-X Side Effects

30/06/10

What is SYMPT-X G.I. (glutamine)?

What is the most important information I should know about SYMPT-X G.I. (glutamine)?

What should I discuss with my health care provider before taking SYMPT-X G.I. (glutamine)?

How should I take SYMPT-X G.I. (glutamine)?

What happens if I miss a dose?

What happens if I overdose?

What should I avoid while taking SYMPT-X G.I. (glutamine)?

SYMPT-X G.I. (glutamine) side effects

What other drugs will affect SYMPT-X G.I. (glutamine)?

Where can I get more information?

30/06/10

Symlin Pen is used for:

Do NOT use Symlin Pen if:

Before using Symlin Pen:

How to use Symlin Pen:

Important safety information:

Possible side effects of Symlin Pen:

If OVERDOSE is suspected:

General information:

30/06/10

Uses For SymlinPen

Before Using SymlinPen

Allergies

Pediatric

Geriatric

Pregnancy

Breast Feeding

Interactions with Medicines

Interactions with Food/Tobacco/Alcohol

Other Medical Problems

Proper Use of pramlintide

Dosing

Missed Dose

Storage

Precautions While Using SymlinPen

SymlinPen Side Effects

30/06/10

What is SymlinPen 120 (pramlintide)?

What is the most important information I should know about SymlinPen 120 (pramlintide)?

What should I discuss with my doctor before using SymlinPen 120 (pramlintide)?

How should I use SymlinPen 120 (pramlintide)?

What happens if I miss a dose?

What happens if I overdose?

What should I avoid while using SymlinPen 120 (pramlintide)?

SymlinPen 120 (pramlintide) side effects

What other drugs will affect SymlinPen 120 (pramlintide)?

Where can I get more information?

30/06/10

What is SymlinPen 60 (pramlintide)?