Hylorel
30/06/10
Generic Name: guanadrel (GWAH na drel)
Brand Names: Hylorel
What is Hylorel (guanadrel)?
Guanadrel lowers blood pressure by decreasing the levels of certain chemicals in the blood. This allows the blood vessels (veins and arteries) to relax (widen).
Guanadrel is used to treat hypertension (high blood pressure).
Guanadrel may also be used for purposes other than those listed in this medication guide.
What is the most important information I should know about Hylorel (guanadrel)?
Do not stop taking guanadrel suddenly without first talking to your doctor. This could cause severely high blood pressure, nervousness, and anxiety. Use caution when driving, operating machinery, or performing other hazardous activities. Guanadrel may cause dizziness or drowsiness. If you experience dizziness or drowsiness, avoid these activities.
Use caution when rising from a sitting or lying position, especially first thing in the morning. Dizziness may occur while taking guanadrel and may result in a fall.
What should I discuss with my healthcare provider before taking Hylorel (guanadrel)?
Do not take guanadrel without first talking to your doctor if you
-
have congestive heart failure;
-
have pheochromocytoma; or
-
are taking a monoamine oxidase inhibitor (MAOI) such as isocarboxazid (Marplan), phenelzine (Nardil), or tranylcypromine (Parnate).
Before taking this medication, tell your doctor if you have
-
peptic ulcer disease (stomach ulcers);
-
ulcerative colitis;
- kidney disease; or
-
asthma.
You may require a dosage adjustment or special monitoring during treatment if you have any of the conditions listed above.
Guanadrel is in the FDA pregnancy category B. This means that it is not expected to be harmful to an unborn baby. Do not take guanadrel without first talking to your doctor if you are pregnant or could become pregnant during treatment. Guanadrel passes into breast milk and it may be harmful to a nursing infant. Do not take guanadrel without first talking to your doctor if you are breast-feeding a baby.
How should I take Hylorel (guanadrel)?
Take guanadrel exactly as directed. If you do not understand these directions, ask your pharmacist, nurse, or doctor to explain them to you.
Take each dose with a full glass of water. Take guanadrel with food or milk if it causes stomach upset.
It is important to take guanadrel regularly to get the most benefit.
Do not stop taking guanadrel suddenly without first talking to your doctor. This could cause severely high blood pressure, nervousness, and anxiety.
Your doctor may want you to have blood pressure monitoring or other medical evaluations during treatment with guanadrel to monitor progress and side effects.
Store this medication at room temperature away from moisture and heat.
What happens if I miss a dose?
Take the missed dose as soon as you remember. However, if it is almost time for the next dose, skip the dose you missed and take only the next regularly scheduled dose. Do not take a double dose of this medication.
What happens if I overdose?
Seek emergency medical attention if an overdose is suspected.
Symptoms of a guanadrel overdose include low blood pressure (fainting, dizziness, weakness); a slow pulse; low body temperature; diarrhea; and slow breathing.
What should I avoid while taking Hylorel (guanadrel)?
Use caution when driving, operating machinery, or performing other hazardous activities. Guanadrel may cause dizziness or drowsiness. If you experience dizziness or drowsiness, avoid these activities.
Use caution when rising from a sitting or lying position, especially first thing in the morning. Dizziness may occur while taking guanadrel and may result in a fall.
Avoid alcohol while taking guanadrel. It may increase drowsiness an dizziness caused by guanadrel. Use caution even with small amounts of alcohol.
Guanadrel may increase the effects of other drugs that cause drowsiness, including antidepressants, alcohol, antihistamines, pain relievers, anxiety medicines, seizure medicines, and muscle relaxants. Dangerous sedation, dizziness, or drowsiness may occur if guanadrel is taken with any of these medications. Tell your doctor about all medicines that you are taking, and do not take any medicine without first talking to your doctor.
Avoid becoming overheated in hot weather or during exercise. Also avoid standing for long periods of time and use caution if you have a fever. These situations increase the effects of guanadrel in the body and may cause dizziness.
Before having surgery, tell your doctor or dentist that you are taking this medication.
Hylorel (guanadrel) side effects
If you experience any of the following serious side effects, stop taking guanadrel and seek emergency medical attention or contact your doctor immediately:
-
an allergic reaction (difficulty breathing; closing of the throat; swelling of the lips, tongue, or face; or hives);
-
irregular heartbeats;
-
heart failure (shortness of breath, swelling of ankles or legs, sudden weight gain of 5 pounds or more); or
-
chest pain.
Other, less serious side effects are more likely to occur. Continue to take guanadrel and talk to your doctor if you experience
-
unusual fatigue or drowsiness;
-
dizziness (avoid standing up to quickly and use caution when performing hazardous activities);
-
anxiety, depression, or nightmares;
-
diarrhea, nausea, or vomiting (take guanadrel with food or milk if it upsets your stomach);
-
a stuffy nose or a dry mouth (sucking on ice chips or sugarless hard candy may relieve a dry mouth);
-
blurred vision;
-
weight gain; or
- impotence or difficulty ejaculating.
Side effects other than those listed here may also occur. Talk to your doctor about any side effect that seems unusual or that is especially bothersome.
What other drugs will affect Hylorel (guanadrel)?
Do not take guanadrel without first talking to your doctor if you have taken a monoamine oxidase inhibitor (MAOI) such as isocarboxazid (Marplan), phenelzine (Nardil), or tranylcypromine (Parnate) in the last 14 days
Before taking guanadrel, tell your doctor if you are taking any of the following medicines:
-
a respiratory medicine such as albuterol (Ventolin, Proventil, Volmax, others), pirbuterol (Maxair), salmeterol (Serevent), and others;
-
a beta-blocker such as atenolol (Tenormin), acebutolol (Sectral), bisoprolol (Zebeta), carteolol (Cartrol), carvedilol (Coreg), labetalol (Trandate, Normodyne), metoprolol (Lopressor), nadolol (Corgard), propranolol (Inderal), pindolol (Visken), and timolol (Blocadren);
-
a phenothiazine such as chlorpromazine (Thorazine), prochlorperazine (Compazine), perphenazine (Trilafon), fluphenazine (Prolixin), thioridazine (Mellaril), and others;
-
other heart medications such as hydralazine (Apresoline) or minoxidil (Loniten); or
-
a tricyclic antidepressant such as amitriptyline (Elavil, Endep), imipramine (Tofranil), doxepin (Sinequan), nortriptyline (Pamelor), and others.
You may require special monitoring or a dosage adjustment if you are taking any of the medicines listed above.
Guanadrel may increase the effects of other drugs that cause drowsiness, including antidepressants, alcohol, antihistamines, sedatives (used to treat insomnia), pain relievers, anxiety medicines, seizure medicines, and muscle relaxants. Tell your doctor about all medicines that you are taking, and do not take any medicine without first talking to your doctor.
Drugs other than those listed here may also interact with guanadrel or affect your condition. Talk to your doctor and pharmacist before taking any prescription or over-the-counter medicines, including vitamins, minerals, and herbal products.
Where can I get more information?
- Your pharmacist has additional information about guanadrel written for health professionals that you may read.
What does my medication look like?
Guanadrel is available with a prescription under the brand name Hylorel. Other brand or generic formulations may also be available. Ask your pharmacist any questions you have about this medication, especially if it is new to you.
-
Hylorel 10 mg–light-orange, elliptical, scored tablets
-
Hylorel 25 mg–white, elliptical, scored tablets
- 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.
Copyright 1996-2006 Cerner Multum, Inc. Version: 6.02. Revision Date: 2/13/04 4:00:59 PM.
Hyoscyamine Elixir
30/06/10
Generic Name: Hyoscyamine (HYE-oh-SYE-a-meen)
Brand Name: Hyosyne
Hyoscyamine Elixir is used for:
Treating certain stomach, intestinal, and bladder conditions, including spasms. It is used to control stomach secretions and cramps. It is used to relieve the symptoms of colic, runny nose, and Parkinson-like problems. It is used to treat excessive sweating or saliva production. It may also be used for other conditions as determined by your doctor.
Hyoscyamine Elixir is an anticholinergic agent. It works by decreasing the motion of muscles in the stomach, intestines, and bladder. It also decreases the production of stomach acid.
Do NOT use Hyoscyamine Elixir if:
- you are allergic to any ingredient in Hyoscyamine Elixir
- you have severe esophagus problems (eg, irritation, narrowing); a blockage of the stomach, bowel, or bladder; bowel motility problems; or severe bowel problems (eg, severe ulcerative colitis, toxic megacolon)
- you have glaucoma, myasthenia gravis, or heart problems caused by severe bleeding
Contact your doctor or health care provider right away if any of these apply to you.
Before using Hyoscyamine Elixir:
Some medical conditions may interact with Hyoscyamine Elixir. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:
- if you are pregnant, 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 nerve problems, prostate problems, esophagus problems (eg, reflux), stomach or bowel problems, heart or blood vessel problems (eg, fast or irregular heartbeat, heart failure, coronary heart disease), hiatal hernia, kidney problems, an overactive thyroid, high blood pressure, urinary problems, paralysis, or brain damage, or if you are at risk for glaucoma
- if you have diarrhea or fever, have been very ill, or are in poor health
Some MEDICINES MAY INTERACT with Hyoscyamine Elixir. Tell your health care provider if you are taking any other medicines, especially any of the following:
- Amantadine, antihistamines (eg, diphenhydramine), haloperidol, monoamine oxidase inhibitors (MAOIs) (eg, phenelzine), other anticholinergics (eg, scopolamine), phenothiazines (eg, thioridazine), or tricyclic antidepressants (eg, amitriptyline) because they may increase the risk of Hyoscyamine Elixir’s side effects
- Narcotic pain medicines (eg, codeine) or potassium chloride because the risk of their side effects may be increased by Hyoscyamine Elixir
- Ketoconazole or metoclopramide because their effectiveness may be decreased by Hyoscyamine Elixir
This may not be a complete list of all interactions that may occur. Ask your health care provider if Hyoscyamine Elixir may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.
How to use Hyoscyamine Elixir:
Use Hyoscyamine Elixir as directed by your doctor. Check the label on the medicine for exact dosing instructions.
- Hyoscyamine Elixir is usually taken 30 to 60 minutes before a meal. Follow your doctor’s instructions for taking Hyoscyamine Elixir.
- Use a measuring device marked for medicine dosing. Ask your pharmacist for help if you are unsure of how to measure your dose.
- If you also take antacids, take Hyoscyamine Elixir before meals and the antacid after meals, unless directed otherwise by your doctor.
- If you miss a dose of Hyoscyamine Elixir, take it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once.
Ask your health care provider any questions you may have about how to use Hyoscyamine Elixir.
Important safety information:
- Hyoscyamine Elixir may cause drowsiness, dizziness, blurred vision, or lightheadedness. These effects may be worse if you take it with alcohol or certain medicines. Use Hyoscyamine Elixir 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 Hyoscyamine Elixir; it may add to their effects. Ask your pharmacist if you have questions about which medicines may cause drowsiness.
- Do NOT take more than the recommended dose or use for longer than prescribed without checking with your doctor.
- Do not become overheated or dehydrated in hot weather or while you are being active; heatstroke may occur.
- Drink plenty of fluids, maintain good oral hygiene, and suck on sugarless hard candy to relieve dry mouth.
- Proper dental care is important while you are taking Hyoscyamine Elixir. Brush and floss your teeth and visit the dentist regularly.
- Hyoscyamine Elixir may make your eyes more sensitive to sunlight. It may help to wear sunglasses.
- Tell your doctor or dentist that you take Hyoscyamine Elixir before you receive any medical or dental care, emergency care, or surgery.
- Use Hyoscyamine Elixir with caution in the ELDERLY; they may be more sensitive to its effects, especially constipation, trouble urinating, dry mouth, drowsiness, agitation, confusion, excitability, or memory problems.
- Caution is advised when using Hyoscyamine Elixir in CHILDREN; they may be more sensitive to its effects, including excitability.
- Hyoscyamine Elixir should be used with extreme caution in CHILDREN younger than 2 years old; safety and effectiveness in these children have not been confirmed.
- PREGNANCY and BREAST-FEEDING: It is not known if Hyoscyamine Elixir can cause harm to the fetus. If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Hyoscyamine Elixir while you are pregnant. Hyoscyamine Elixir is found in breast milk. If you are or will be breast-feeding while taking Hyoscyamine Elixir, check with your doctor. Discuss any possible risks to your baby.
Possible side effects of Hyoscyamine Elixir:
All medicines may cause side effects, but many people have no, or minor side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:
Bloated feeling; blurred vision; constipation; decreased sweating; dizziness; drowsiness; dry mouth; enlarged pupils; excitability; headache; nausea; nervousness; trouble sleeping; 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); agitation; behavior changes; confusion; decreased sexual ability; diarrhea; difficulty focusing eyes; disorientation; exaggerated sense of well-being; fast or irregular heartbeat; hallucinations; loss of consciousness; loss of coordination; memory loss; mental or mood changes; severe or persistent trouble sleeping; speech changes; taste changes or loss; trouble urinating; unusual tiredness or weakness; vision changes; 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. Symptoms may include disorientation; excessive thirst or excitability; fever; hot, dry skin; seizures; severe dry mouth; severe or persistent blurred vision, dizziness, headache, nausea, or vomiting; trouble breathing or swallowing.
Proper storage of Hyoscyamine Elixir:
Store Hyoscyamine Elixir at room temperature, between 59 and 86 degrees F (15 and 30 degrees C). Store away from heat, moisture, and light. Do not store in the bathroom. Keep Hyoscyamine Elixir out of the reach of children and away from pets.
General information:
- If you have any questions about Hyoscyamine Elixir, please talk with your doctor, pharmacist, or other health care provider.
- Hyoscyamine Elixir is to be used only by the patient for whom it is prescribed. Do not share it with other people.
- If your symptoms do not improve or if they become worse, check with your doctor.
This information is a summary only. It does not contain all information about Hyoscyamine Elixir. If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.
Generic Name: Hyoscyamine (HYE-oh-SYE-a-meen)
Brand Name: Symax Duotab
Hyoscyamine Controlled-Release Tablets are used for:
Treating certain stomach, intestinal, and bladder conditions, including spasms. It is used to control stomach secretions and cramps. It is used to relieve the symptoms of colic or runny nose. It may also be used for other conditions as determined by your doctor.
Hyoscyamine Controlled-Release Tablets are an anticholinergic agent. It works by decreasing the motion of muscles in the stomach, intestines, and bladder. It also decreases the production of stomach acid.
Do NOT use Hyoscyamine Controlled-Release Tablets if:
- you are allergic to any ingredient in Hyoscyamine Controlled-Release Tablets
- you have severe esophagus problems (eg, irritation, narrowing); a blockage of the stomach, bowel, or bladder; bowel motility problems; or severe bowel problems (eg, severe ulcerative colitis, toxic megacolon)
- you have glaucoma, myasthenia gravis, or heart problems caused by severe bleeding
Contact your doctor or health care provider right away if any of these apply to you.
Before using Hyoscyamine Controlled-Release Tablets:
Some medical conditions may interact with Hyoscyamine Controlled-Release Tablets. 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 nerve problems, prostate problems, esophagus problems (eg, reflux), stomach or bowel problems, heart or blood vessel problems (eg, fast or irregular heartbeat, heart failure, coronary heart disease), hiatal hernia, kidney problems, an overactive thyroid, high blood pressure, urinary problems, paralysis, or brain damage, or if you are at risk for glaucoma
- if you have diarrhea or fever, have been very ill, or are in poor health
Some MEDICINES MAY INTERACT with Hyoscyamine Controlled-Release Tablets. Tell your health care provider if you are taking any other medicines, especially any of the following:
- Amantadine, antihistamines (eg, diphenhydramine), haloperidol, monoamine oxidase inhibitors (MAOIs) (eg, phenelzine), other anticholinergics (eg, scopolamine), phenothiazines (eg, thioridazine), or tricyclic antidepressants (eg, amitriptyline) because they may increase the risk of Hyoscyamine Controlled-Release Tablets’s side effects
- Narcotic pain medicines (eg, codeine) or potassium chloride because the risk of their side effects may be increased by Hyoscyamine Controlled-Release Tablets
- Ketoconazole or metoclopramide because their effectiveness may be decreased by Hyoscyamine Controlled-Release Tablets
This may not be a complete list of all interactions that may occur. Ask your health care provider if Hyoscyamine Controlled-Release Tablets 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 Hyoscyamine Controlled-Release Tablets:
Use Hyoscyamine Controlled-Release Tablets as directed by your doctor. Check the label on the medicine for exact dosing instructions.
- Hyoscyamine Controlled-Release Tablets are usually taken 30 to 60 minutes before a meal. Follow your doctor’s instructions for taking Hyoscyamine Controlled-Release Tablets.
- Swallow Hyoscyamine Controlled-Release Tablets whole. Do not break, crush, or chew before swallowing.
- If you also take antacids, ask your doctor or pharmacist how to take them with Hyoscyamine Controlled-Release Tablets.
- If you miss a dose of Hyoscyamine Controlled-Release Tablets, 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 Hyoscyamine Controlled-Release Tablets.
Important safety information:
- Hyoscyamine Controlled-Release Tablets may cause drowsiness, dizziness, blurred vision, or lightheadedness. These effects may be worse if you take it with alcohol or certain medicines. Use Hyoscyamine Controlled-Release Tablets 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 Hyoscyamine Controlled-Release Tablets; it may add to their effects. Ask your pharmacist if you have questions about which medicines may cause drowsiness.
- Do NOT take more than the recommended dose or use for longer than prescribed without checking with your doctor.
- Do not become overheated or dehydrated in hot weather or while you are being active; heatstroke may occur.
- Drink plenty of fluids, maintain good oral hygiene, and suck on sugarless hard candy to relieve dry mouth.
- Proper dental care is important while you are taking Hyoscyamine Controlled-Release Tablets. Brush and floss your teeth and visit the dentist regularly.
- Hyoscyamine Controlled-Release Tablets may make your eyes more sensitive to sunlight. It may help to wear sunglasses.
- Tell your doctor or dentist that you take Hyoscyamine Controlled-Release Tablets before you receive any medical or dental care, emergency care, or surgery.
- Use Hyoscyamine Controlled-Release Tablets with caution in the ELDERLY; they may be more sensitive to its effects, especially constipation, trouble urinating, dry mouth, drowsiness, agitation, confusion, excitability, or memory problems.
- Caution is advised when using Hyoscyamine Controlled-Release Tablets in CHILDREN; they may be more sensitive to its effects, including excitability.
- Hyoscyamine Controlled-Release Tablets should be used with extreme caution in CHILDREN younger than 2 years old; safety and effectiveness in these children have not been confirmed.
- PREGNANCY and BREAST-FEEDING: It is not known if Hyoscyamine Controlled-Release Tablets can cause harm to the fetus. If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Hyoscyamine Controlled-Release Tablets while you are pregnant. Hyoscyamine Controlled-Release Tablets are found in breast milk. If you are or will be breast-feeding while taking Hyoscyamine Controlled-Release Tablets, check with your doctor. Discuss any possible risks to your baby.
Possible side effects of Hyoscyamine Controlled-Release Tablets:
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:
Bloated feeling; blurred vision; constipation; decreased sweating; dizziness; drowsiness; dry mouth; enlarged pupils; excitability; headache; nausea; nervousness; trouble sleeping; 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); agitation; behavior changes; confusion; decreased sexual ability; diarrhea; difficulty focusing eyes; disorientation; exaggerated sense of well-being; fast or irregular heartbeat; hallucinations; loss of consciousness; loss of coordination; memory loss; mental or mood changes; severe or persistent trouble sleeping; speech changes; taste changes or loss; trouble urinating; unusual tiredness or weakness; vision changes; 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. Symptoms may include disorientation; excessive thirst or excitability; fever; hot, dry skin; seizures; severe dry mouth; severe or persistent blurred vision, dizziness, headache, nausea, or vomiting; trouble breathing or swallowing.
Proper storage of Hyoscyamine Controlled-Release Tablets:
Store Hyoscyamine Controlled-Release Tablets at room temperature, between 59 and 86 degrees F (15 and 30 degrees C). Store away from heat, moisture, and light. Do not store in the bathroom. Keep Hyoscyamine Controlled-Release Tablets out of the reach of children and away from pets.
General information:
- If you have any questions about Hyoscyamine Controlled-Release Tablets, please talk with your doctor, pharmacist, or other health care provider.
- Hyoscyamine Controlled-Release Tablets are 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 Hyoscyamine Controlled-Release Tablets. 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.
Hyoscyamine
30/06/10
Generic Name: Hyoscyamine (HYE-oh-SYE-a-meen)
Brand Name: Levsin
Hyoscyamine is used for:
Treating certain stomach or bowel problems (eg, ulcers, spasms or cramping, irritable bowel syndrome, symptoms of colic), certain bladder problems (eg, spastic bladder, cystitis), and excessive secretions caused by inflammation of the pancreas, and for aiding in certain medical procedures or surgery. It may also be used for other conditions as determined by your doctor.
Hyoscyamine is an anticholinergic agent. It works by decreasing the motion of the stomach and intestines and the secretion of stomach fluids, including acid.
Do NOT use Hyoscyamine if:
- you are allergic to any ingredient in Hyoscyamine
- you have severe esophagus problems (eg, irritation, narrowing); a blockage of the stomach, bowel, or bladder; bowel motility problems; or severe bowel problems (eg, severe ulcerative colitis, toxic megacolon)
- you have glaucoma, myasthenia gravis, or heart problems caused by severe bleeding
Contact your doctor or health care provider right away if any of these apply to you.
Before using Hyoscyamine:
Some medical conditions may interact with Hyoscyamine. 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 nerve problems, prostate problems, esophagus problems (eg, reflux), stomach or bowel problems, heart or blood vessel problems (eg, fast or irregular heartbeat, heart failure, coronary heart disease), hiatal hernia, kidney problems, an overactive thyroid, high blood pressure, urinary problems, paralysis, or brain damage, or if you are at risk for glaucoma
- if you have diarrhea or fever, have been very ill, or are in poor health
Some MEDICINES MAY INTERACT with Hyoscyamine. Tell your health care provider if you are taking any other medicines, especially any of the following:
- Amantadine, antihistamines (eg, diphenhydramine), haloperidol, monoamine oxidase inhibitors (MAOIs) (eg, phenelzine), other anticholinergics (eg, scopolamine), phenothiazines (eg, thioridazine), or tricyclic antidepressants (eg, amitriptyline) because they may increase the risk of Hyoscyamine’s side effects
- Narcotic pain medicines (eg, codeine) or potassium chloride because the risk of their side effects may be increased by Hyoscyamine
- Ketoconazole or metoclopramide because their effectiveness may be decreased by Hyoscyamine
This may not be a complete list of all interactions that may occur. Ask your health care provider if Hyoscyamine 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 Hyoscyamine:
Use Hyoscyamine as directed by your doctor. Check the label on the medicine for exact dosing instructions. Check the label on the medicine for exact dosing instructions.
- Hyoscyamine is usually given as an injection at your doctor’s office, hospital, or clinic. If you will be using Hyoscyamine at home, a health care provider will teach you how to use it. Be sure you understand how to use Hyoscyamine. Follow the procedures you are taught when you use a dose. Contact your health care provider if you have any questions.
- Do not use Hyoscyamine if it contains particles, is cloudy or discolored, or if the vial is cracked or damaged.
- 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.
- If you miss a dose of Hyoscyamine, use it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not use 2 doses at once.
Ask your health care provider any questions you may have about how to use Hyoscyamine.
Important safety information:
- Hyoscyamine may cause drowsiness, dizziness, blurred vision, or lightheadedness. These effects may be worse if you take it with alcohol or certain medicines. Use Hyoscyamine 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 Hyoscyamine; it may add to their effects. Ask your pharmacist if you have questions about which medicines may cause drowsiness.
- Do NOT take more than the recommended dose or use for longer than prescribed without checking with your doctor.
- Do not become overheated or dehydrated in hot weather or while you are being active; heatstroke may occur.
- Drink plenty of fluids, maintain good oral hygiene, and suck on sugarless hard candy to relieve dry mouth.
- Proper dental care is important while you are taking Hyoscyamine. Brush and floss your teeth and visit the dentist regularly.
- Hyoscyamine may make your eyes more sensitive to sunlight. It may help to wear sunglasses.
- Tell your doctor or dentist that you take Hyoscyamine before you receive any medical or dental care, emergency care, or surgery.
- Use Hyoscyamine with caution in the ELDERLY; they may be more sensitive to its effects, especially constipation, trouble urinating, dry mouth, drowsiness, agitation, confusion, excitability, or memory problems.
- Caution is advised when using Hyoscyamine in CHILDREN; they may be more sensitive to its effects, including excitability.
- Hyoscyamine should be used with extreme caution in CHILDREN younger than 12 years old; safety and effectiveness in these children have not been confirmed.
- PREGNANCY and BREAST-FEEDING: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Hyoscyamine while you are pregnant. Hyoscyamine is found in breast milk. Do not breast-feed while taking Hyoscyamine.
Possible side effects of Hyoscyamine:
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:
Bloated feeling; blurred vision; constipation; decreased sweating; dizziness; drowsiness; dry mouth; enlarged pupils; excitability; headache; nausea; nervousness; trouble sleeping; 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); agitation; behavior changes; confusion; decreased sexual ability; diarrhea; difficulty focusing eyes; disorientation; exaggerated sense of well-being; fast or irregular heartbeat; hallucinations; loss of consciousness; loss of coordination; memory loss; mental or mood changes; severe or persistent trouble sleeping; speech changes; taste changes or loss; trouble urinating; unusual tiredness or weakness; vision changes; 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. Symptoms may include blurred vision; difficulty breathing; difficulty swallowing; disorientation; dizziness; dry mouth; dry skin; enlarged pupils; excessive thirst; excitability; headache; muscle weakness; nausea; rapid heartbeat with weak pulse; seizures; vomiting.
Proper storage of Hyoscyamine:
Hyoscyamine is usually handled and stored by a health care provider. If you are using Hyoscyamine at home, store Hyoscyamine as directed by your pharmacist or health care provider. Keep Hyoscyamine out of the reach of children and away from pets.
General information:
- If you have any questions about Hyoscyamine, please talk with your doctor, pharmacist, or other health care provider.
- Hyoscyamine 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 Hyoscyamine. 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.
Generic Name: Hyoscyamine (HYE-oh-SYE-a-meen)
Brand Name: Levsinex
Hyoscyamine Extended-Release Capsules are used for:
Treating certain stomach, intestinal, and bladder conditions, including spasms. It is used to control stomach secretions and cramps. It is used to relieve the symptoms of colic, runny nose, and Parkinson-like problems. It is used to treat excessive sweating or saliva production. It may also be used for other conditions as determined by your doctor.
Hyoscyamine Extended-Release Capsules are an anticholinergic agent. It works by decreasing the motion of muscles in the stomach, intestines, and bladder. It also decreases the production of stomach acid.
Do NOT use Hyoscyamine Extended-Release Capsules if:
- you are allergic to any ingredient in Hyoscyamine Extended-Release Capsules
- you have severe esophagus problems (eg, irritation, narrowing); a blockage of the stomach, bowel, or bladder; bowel motility problems; or severe bowel problems (eg, severe ulcerative colitis, toxic megacolon)
- you have glaucoma, myasthenia gravis, or heart problems caused by severe bleeding
Contact your doctor or health care provider right away if any of these apply to you.
Before using Hyoscyamine Extended-Release Capsules:
Some medical conditions may interact with Hyoscyamine Extended-Release Capsules. 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 nerve problems, prostate problems, esophagus problems (eg, reflux), stomach or bowel problems, heart or blood vessel problems (eg, fast or irregular heartbeat, heart failure, coronary heart disease), hiatal hernia, kidney problems, an overactive thyroid, high blood pressure, urinary problems, paralysis, or brain damage, or if you are at risk for glaucoma
- if you have diarrhea or fever, have been very ill, or are in poor health
Some MEDICINES MAY INTERACT with Hyoscyamine Extended-Release Capsules. Tell your health care provider if you are taking any other medicines, especially any of the following:
- Amantadine, antihistamines (eg, diphenhydramine), haloperidol, monoamine oxidase inhibitors (MAOIs) (eg, phenelzine), other anticholinergics (eg, scopolamine), phenothiazines (eg, thioridazine), or tricyclic antidepressants (eg, amitriptyline) because they may increase the risk of Hyoscyamine Extended-Release Capsules’s side effects
- Narcotic pain medicines (eg, codeine) or potassium chloride because the risk of their side effects may be increased by Hyoscyamine Extended-Release Capsules
- Ketoconazole or metoclopramide because their effectiveness may be decreased by Hyoscyamine Extended-Release Capsules
This may not be a complete list of all interactions that may occur. Ask your health care provider if Hyoscyamine Extended-Release Capsules 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 Hyoscyamine Extended-Release Capsules:
Use Hyoscyamine Extended-Release Capsules as directed by your doctor. Check the label on the medicine for exact dosing instructions.
- Hyoscyamine Extended-Release Capsules are usually taken 30 to 60 minutes before a meal. Follow your doctor’s instructions for taking Hyoscyamine Extended-Release Capsules.
- Swallow Hyoscyamine Extended-Release Capsules whole. Do not break, crush, or chew before swallowing.
- If you also take antacids, ask your doctor or pharmacist how to take them with Hyoscyamine Extended-Release Capsules.
- If you miss a dose of Hyoscyamine Extended-Release Capsules, 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 Hyoscyamine Extended-Release Capsules.
Important safety information:
- Hyoscyamine Extended-Release Capsules may cause drowsiness, dizziness, blurred vision, or lightheadedness. These effects may be worse if you take it with alcohol or certain medicines. Use Hyoscyamine Extended-Release Capsules 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 Hyoscyamine Extended-Release Capsules; it may add to their effects. Ask your pharmacist if you have questions about which medicines may cause drowsiness.
- Do NOT take more than the recommended dose or use for longer than prescribed without checking with your doctor.
- Do not become overheated or dehydrated in hot weather or while you are being active; heatstroke may occur.
- Drink plenty of fluids, maintain good oral hygiene, and suck on sugarless hard candy to relieve dry mouth.
- Proper dental care is important while you are taking Hyoscyamine Extended-Release Capsules. Brush and floss your teeth and visit the dentist regularly.
- Hyoscyamine Extended-Release Capsules may make your eyes more sensitive to sunlight. It may help to wear sunglasses.
- Tell your doctor or dentist that you take Hyoscyamine Extended-Release Capsules before you receive any medical or dental care, emergency care, or surgery.
- Use Hyoscyamine Extended-Release Capsules with caution in the ELDERLY; they may be more sensitive to its effects, especially constipation, trouble urinating, dry mouth, drowsiness, agitation, confusion, excitability, or memory problems.
- Caution is advised when using Hyoscyamine Extended-Release Capsules in CHILDREN; they may be more sensitive to its effects, including excitability.
- Hyoscyamine Extended-Release Capsules should be used with extreme caution in CHILDREN younger than 2 years old; safety and effectiveness in these children have not been confirmed.
- PREGNANCY and BREAST-FEEDING: It is not known if Hyoscyamine Extended-Release Capsules can cause harm to the fetus. If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Hyoscyamine Extended-Release Capsules while you are pregnant. Hyoscyamine Extended-Release Capsules are found in breast milk. If you are or will be breast-feeding while taking Hyoscyamine Extended-Release Capsules, check with your doctor. Discuss any possible risks to your baby.
Possible side effects of Hyoscyamine Extended-Release Capsules:
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:
Bloated feeling; blurred vision; constipation; decreased sweating; dizziness; drowsiness; dry mouth; enlarged pupils; excitability; headache; nausea; nervousness; trouble sleeping; 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); agitation; behavior changes; confusion; decreased sexual ability; diarrhea; difficulty focusing eyes; disorientation; exaggerated sense of well-being; fast or irregular heartbeat; hallucinations; loss of consciousness; loss of coordination; memory loss; mental or mood changes; severe or persistent trouble sleeping; speech changes; taste changes or loss; trouble urinating; unusual tiredness or weakness; vision changes; 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. Symptoms may include disorientation; excessive thirst or excitability; fever; hot, dry skin; seizures; severe dry mouth; severe or persistent blurred vision, dizziness, headache, nausea, or vomiting; trouble breathing or swallowing.
Proper storage of Hyoscyamine Extended-Release Capsules:
Store Hyoscyamine Extended-Release Capsules at room temperature, between 59 and 86 degrees F (15 and 30 degrees C). Store away from heat, moisture, and light. Do not store in the bathroom. Keep Hyoscyamine Extended-Release Capsules out of the reach of children and away from pets.
General information:
- If you have any questions about Hyoscyamine Extended-Release Capsules, please talk with your doctor, pharmacist, or other health care provider.
- Hyoscyamine Extended-Release Capsules are 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 Hyoscyamine Extended-Release Capsules. 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.
Hylenex
30/06/10
Generic Name: hyaluronidase (Subcutaneous route, Injection route)
hye-al-ure-ON-i-dase
Commonly used brand name(s):
In the U.S.
- Amphadase
- Hydase
- Hylenex
- Vitrase
Available Dosage Forms:
- Powder for Solution
- Solution
Therapeutic Class: Tissue Permeability Modifier
Pharmacologic Class: Enzyme
Uses For Hylenex
Hyaluronidase is a natural substance found in the body. Hyaluronidase is collected from either cows or pigs. It is cleaned up to remove animal substances. Hyaluronidase is a spreading substance. Hyaluronidase is used with other drugs given under the skin to improve their uptake by the body. This method of drug delivery is only used when the drug cannot be given by injection into a vein.
This medicine is available only with your doctor’s prescription.
Before Using Hylenex
In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:
Allergies
Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.
Pediatric
This medicine has been tested in children and, in effective doses, has not been shown to cause different side effects or problems than it does in adults.
Geriatric
This medicine has been tested and has not been shown to cause different side effects or problems in older people than it does in younger adults.
Pregnancy
| Pregnancy Category | Explanation | |
|---|---|---|
| All Trimesters | 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
Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.
- Benzocaine
- Bupivacaine
- Butacaine
- Chloroprocaine
- Cocaine
- Dibucaine
- Etidocaine
- Lidocaine
- Mepivacaine
- Prilocaine
- Procaine
- Proparacaine
- Propoxycaine
- Ropivacaine
- Tetracaine
Interactions with Food/Tobacco/Alcohol
Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.
Other Medical Problems
The presence of other medical problems may affect the use of hyaluronidase. Make sure you tell your doctor if you have any other medical problems.
Proper Use of hyaluronidase
This section provides information on the proper use of a number of products that contain hyaluronidase. It may not be specific to Hylenex. 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 injection dosage form:
- For better uptake of other drugs:
- Adults—Use and dose must be determined by your doctor.
- Children—Use and dose must be determined by your doctor.
- For better uptake of other drugs:
Storage
Store in the refrigerator. Do not freeze.
Keep out of the reach of children.
Do not keep outdated medicine or medicine no longer needed.
Ask your healthcare professional how you should dispose of any medicine you do not use.
Precautions While Using Hylenex
Some people may be allergic to this medicine. Tell your doctor if you develop red or itching skin or if you have trouble breathing after you receive hyaluronidase.
Hylenex Side Effects
Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.
Check with your doctor immediately if any of the following side effects occur:
Rare
- Cough
- difficulty swallowing
- dizziness
- fast heartbeat
- hives or welts
- itching
- large, hive-like swelling on face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs
- puffiness or swelling of the eyelids or around the eyes, face, lips or tongue
- redness of skin
- shortness of breath
- skin rash
- tightness in chest
- unusual tiredness or weakness
- wheezing
Symptoms of Overdose
Get emergency help immediately if any of the following symptoms of overdose occur:
- Blurred vision
- chills
- confusion
- dizziness
- dizziness, faintness, or lightheadedness when getting up from a lying or sitting position suddenly
- fast, pounding, or irregular heartbeat or pulse
- flushing
- nausea
- redness of skin
- swelling
- unusually warm skin
- sweating
- unusual tiredness or weakness
- vomiting
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
- 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 injection site
Incidence not known
- Swelling
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.
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Hylenex Recombinant
30/06/10
Generic Name: hyaluronidase recombinant human
Dosage Form: injection, solution
1. INDICATIONS AND USAGE
Subcutaneous Fluid Administration
Hylenex Recombinant is indicated as an adjuvant in subcutaneous fluid administration for achieving hydration.
Dispersion and Absorption of Injected Drugs
Hylenex Recombinant is indicated as an adjuvant to increase the dispersion and absorption of other injected drugs.
Subcutaneous Urography
Hylenex Recombinant is indicated as an adjunct in subcutaneous urography for improving resorption of radiopaque agents.
2. DOSAGE AND ADMINISTRATION
Always use aseptic precautions. Lightly pinch the skin up into a small mound and insert the needle/catheter into the subcutaneous space. Inject Hylenex Recombinant through the catheter hub or injection port closest to the needle/catheter. Begin administration of the injection solution. Solution should start in readily.
Subcutaneous Fluid Administration
150 U of Hylenex Recombinant injected prior to start of subcutaneous fluid administration will facilitate absorption of 1,000 mL or more of solution. As with all parenteral fluid therapy, observe effect closely, with the same precautions for restoring fluid and electrolyte balance as in intravenous injections. The dose, the rate of injection, and the type of solution (saline, glucose, Ringer’s, etc.) must be adjusted carefully to the individual patient. When solutions devoid of inorganic electrolytes are administered subcutaneously, hypovolemia may occur. This may be prevented by using solutions containing adequate amounts of inorganic electrolytes and/or controlling the volume and speed of administration.
Hylenex Recombinant may be added to small volumes of solution, such as fluid replacement solutions or solutions of drugs for subcutaneous injection. Subcutaneous fluids should be administered as directed by a physician. The dosage of subcutaneous fluids administered is dependent upon the age, weight, and clinical condition of the patient as well as laboratory determinations. The rate and volume of subcutaneous fluid administration should not exceed those employed for intravenous infusion. For premature infants or during the neonatal period, the daily dosage should not exceed 25 mL/kg of body weight, and the rate of administration should not be greater than 2 mL per minute.
Dispersion and Absorption of Injected Drugs
Dispersion and absorption of other injected drugs may be enhanced by adding 50-300 U, most typically 150 U hyaluronidase, to the injection solution.
It is recommended that appropriate references be consulted regarding physical or chemical incompatibilities before adding Hylenex Recombinant to a solution containing another drug.
Subcutaneous Urography
The subcutaneous route of administration of urographic contrast media is indicated when intravenous administration cannot be successfully accomplished, particularly in infants and small children. With the patient prone, 75 U of Hylenex Recombinant is injected subcutaneously over each scapula, followed by injection of the contrast medium at the same sites.
Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration whenever solution and container permit.
3. DOSAGE FORMS AND STRENGTHS
150 USP units/mL single dose vials
4. CONTRAINDICATIONS
HYLENEX is contraindicated in patients with known hypersensitivity to hyaluronidase or any of the excipients in HYLENEX. A preliminary skin test for hypersensitivity to Hylenex Recombinant can be performed. The skin test is made by an intradermal injection of approximately 0.02 mL (3 Units) of a 150 Unit/mL solution. A positive reaction consists of a wheal with pseudopods appearing within 5 minutes and persisting for 20 to 30 minutes and accompanied by localized itching. Transient vasodilation at the site of the test, i.e., erythema, is not a positive reaction.
5. WARNINGS AND PRECAUTIONS
Spread of Localized Infection
Hyaluronidase should not be injected into or around an infected or acutely inflamed area because of the danger of spreading a localized infection.
Hyaluronidase should not be used to reduce the swelling of bites or stings.
Ocular Damage
Hyaluronidase should not be applied directly to the cornea. It is not for topical use.
Enzyme Inactivation with Intravenous Administration
Hylenex Recombinant should not be administered intravenously. Its effects relative to dispersion and absorption of other drugs are not produced when it is administered intravenously because the enzyme is rapidly inactivated.
6. ADVERSE REACTIONS
The following adverse reactions have been identified during post-approval use of hyaluronidase products. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
The most frequently reported adverse experiences have been mild local injection site reactions such as erythema and pain. Hyaluronidase has been reported to enhance the adverse events associated with co-administered drug products. Edema has been reported most frequently in association with subcutaneous fluid administration. Allergic reactions (urticaria or angioedema) have been reported in less than 0.1% of patients receiving hyaluronidase. Anaphylactic-like reactions following retrobulbar block or intravenous injections have occurred, rarely.
7. DRUG INTERACTIONS
Incompatibilities
Furosemide, the benzodiazepines and phenytoin have been found to be incompatible with hyaluronidase.
Drug-Specific Precautions
Hyaluronidase should not be used to enhance the dispersion and absorption of dopamine and/or alpha agonist drugs.
When considering the administration of any other drug with hyaluronidase, it is recommended that appropriate references first be consulted to determine the usual precautions for the use of the other drug.
Local Anesthetics
When hyaluronidase is added to a local anesthetic agent, it hastens the onset of analgesia and tends to reduce the swelling caused by local infiltration, but the wider spread of the local anesthetic solution increases its absorption; this shortens its duration of action and tends to increase the incidence of systemic reaction.
Salicylates, Cortisone, ACTH, Estrogens and Antihistamines
Patients receiving large doses of salicylates, cortisone, ACTH, estrogens or antihistamines may require larger amounts of hyaluronidase for equivalent dispersing effect, since these drugs apparently render tissues partly resistant to the action of hyaluronidase.
8. USE IN SPECIFIC POPULATIONS
Pregnancy
Pregnancy Category C. Animal reproduction studies have not been conducted with Hylenex Recombinant. It is also not known whether Hylenex Recombinant can cause fetal harm when administered to a pregnant woman. Hylenex Recombinant should be given to a pregnant woman only if clearly needed.
Labor and Delivery
Administration of hyaluronidase during labor was reported to cause no complications: no increase in blood loss or differences in cervical trauma were observed.
Nursing Mothers
It is not known whether hyaluronidase is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when hyaluronidase is administered to a nursing woman.
Pediatric Use
Clinical hydration requirements for children can be achieved through administration of subcutaneous fluids facilitated with Hylenex Recombinant.
The dosage of subcutaneous fluids administered is dependent upon the age, weight, and clinical condition of the patient as well as laboratory determinations. The potential for chemical or physical incompatibilities should be kept in mind [See Drug Interactions (7)].
The rate and volume of subcutaneous fluid administration should not exceed those employed for intravenous infusion. For premature infants or during the neonatal period, the daily dosage should not exceed 25 mL/kg of body weight, and the rate of administration should not be greater than 2 mL per minute.
During subcutaneous fluid administration, special care must be taken in pediatric patients to avoid over hydration by controlling the rate and total volume of the infusion. [See Dosage and Administration (2.1)].
Geriatric Use
No overall differences in safety or effectiveness have been observed between elderly and younger adult patients.
11. DESCRIPTION
Hylenex Recombinant is a purified preparation of the enzyme recombinant human hyaluronidase. Hylenex Recombinant is produced by genetically engineered Chinese Hamster Ovary (CHO) cells containing a DNA plasmid encoding for a soluble fragment of human hyaluronidase (PH20). The purified hyaluronidase glycoprotein contains 447 amino acids with an approximate molecular weight of 61,000 Daltons.
Hylenex Recombinant is supplied as a sterile, clear, colorless, nonpreserved, ready for use solution. Each mL contains 150 USP units of recombinant human hyaluronidase with 8.5 mg sodium chloride, 1.4 mg dibasic sodium phosphate, 1.0 mg albumin human, 0.9 mg edetate disodium, 0.3 mg calcium chloride, and sodium hydroxide added for pH adjustment.
Hylenex Recombinant has an approximate pH of 7.4 and an osmolality of 290 to 350 mOsm.
12. CLINICAL PHARMACOLOGY
Mechanism of Action
Hyaluronidase is a dispersion agent, which modifies the permeability of connective tissue through the hydrolysis of hyaluronic acid, a polysaccharide found in the intercellular ground substance of connective tissue, and of certain specialized tissues, such as the umbilical cord and vitreous humor. Hyaluronic acid is also present in the capsules of type A and C hemolytic streptococci. Hyaluronidase hydrolyzes hyaluronic acid by splitting the glucosaminidic bond between C1 of an N-acetylglucosamine moiety and C4 of a glucuronic acid moiety. This temporarily decreases the viscosity of the cellular cement and promotes dispersion of injected fluids or of localized transudates or exudates, thus facilitating their absorption.
Hyaluronidase cleaves glycosidic bonds of hyaluronic acid and, to a variable degree, some other acid mucopolysaccharides of the connective tissue. The activity is measured in vitro by monitoring the decrease in the amount of an insoluble serum albumin-hyaluronic acid complex as the enzyme cleaves the hyaluronic acid component.
Pharmacodynamics
In the absence of hyaluronidase, material injected subcutaneously disperses very slowly. Hyaluronidase facilitates dispersion, provided local interstitial pressure is adequate to furnish the necessary mechanical impulse. Such an impulse is normally initiated by injected solutions. The rate and extent of dispersion and absorption is proportionate to the amount of hyaluronidase and the volume of solution.
The reconstitution of the dermal barrier removed by intradermal injection of hyaluronidase (20, 2, 0.2, 0.02, and 0.002 U/mL) to adult humans indicated that at 24 hours the restoration of the barrier is incomplete and inversely related to the dosage of hyaluronidase; at 48 hours, the barrier is completely restored in all treated areas.
Results from an experimental study, in humans, on the influence of hyaluronidase in bone repair support the conclusion that hyaluronidase alone, in the usual clinical dosage, does not deter bone healing.
Pharmacokinetics
Knowledge of the mechanisms involved in the disappearance of injected hyaluronidase is limited. It is known, however, that the components in blood of a number of mammalian species bring about the inactivation of hyaluronidase.
Studies have demonstrated that hyaluronidase is antigenic; repeated injections of relatively large amounts of hyaluronidase preparations may result in the formation of neutralizing antibodies.
13. NONCLINICAL TOXICOLOGY
Carcinogenesis, Mutagenesis, Impairment of Fertility
Long-term animal studies have not been performed to assess the carcinogenic or mutagenic potential of hyaluronidase. Hyaluronidase is found in most tissues of the body.
Human studies on the effect of intravaginal hyaluronidase in sterility due to oligospermia indicated that hyaluronidase may have aided conception. Thus, it appears that hyaluronidase may not adversely affect fertility in females.
14. CLINICAL STUDIES
Hylenex Recombinant facilitated the administration of subcutaneous fluids in pediatric patients with mild to moderate dehydration in an open-label, multicenter, single arm study in fifty-one (51) patients. A subcutaneous injection of 1 mL (150 U) of Hylenex Recombinant was immediately followed by subcutaneous infusion of isotonic fluids in either the mid-anterior thigh or the inter-scapular area of the upper back.
The safety and flow rate of subcutaneously administered Lactated Ringer’s (LR) solution with and without Hylenex Recombinant was evaluated in a prospective, randomized, double-blinded, placebo-controlled, within-subject, single-center study in fifty-four (54) healthy volunteers. The mean Hylenex Recombinant facilitated infusion rate was 464 mL/hr versus 118 mL/hr for the saline control (p < 0.001, paired t-test).
16. HOW SUPPLIED/STORAGE AND HANDLING
Hylenex Recombinant is supplied sterile as 150 USP units of nonpreserved recombinant human hyaluronidase per mL in a single-use glass vial.
1 mL Single Dose Vial available in boxes of 4 (NDC 60977-319-03)
Not Recommended for IV Use.
Store unopened in a refrigerator at 2° to 8°C (36° to 46° F).
DO NOT FREEZE.
17. PATIENT COUNSELING INFORMATION
Important Precautions Regarding Hylenex Recombinant
Instruct patient that Hylenex Recombinant is being used to increase the dispersion and absorption of fluids or other injected drugs, as appropriate to the intended use.
Instruct patient that there may be mild local injection site signs and symptoms, such as redness, swelling, itching, or pain localized to the site of injection.
What Patients Should Know About Adverse Reactions
The most frequently reported adverse reactions have been mild local injection site reactions such as redness, swelling, itching, or pain.
Anaphylactic-like reactions, and allergic reactions, such as hives, have been reported rarely in patients receiving hyaluronidases.
Patients Should Inform Their Doctors If Taking Other Medications
You may not receive furosemide, the benzodiazepines, phenytoin, dopamine and/or alpha agonists with HYLENEX. These medications have been found to be incompatible with hyaluronidase.
If you are taking salicylates (e.g., aspirin), steroids (e.g., cortisone or estrogens), or antihistamines your doctor may need to prescribe larger amounts of hyaluronidase for equivalent dispersing effect.
Baxter and Hylenex are registered trademarks of Baxter International Inc.
Halozyme is a registered trademark of Halozyme Therapeutics, Inc.
Baxter
Marketed by: Baxter Healthcare Corporation
Deerfield, IL 60015 USA
Halozyme
THERAPEUTICS
Manufactured for: Halozyme Therapeutics, Inc.
San Diego, CA 92121
By Baxter Pharmaceutical Solutions LLC
Bloomington, IN 47403
For Product Inquiry 1 800 ANA DRUG (1-800-262-3784)
PRINCIPAL DISPLAY PANEL – 1 mL Vial Carton
NDC 60977-319-02
Hylenex 1 mL
recombinant
(hyaluronidase
human injection)
150 USP units/mL
NOT FOR IV USE
Rx only
REFRIGERATE
Single Dose Vial
Marketed by
Baxter Healthcare Corporation
Deerfield, IL 60015 USA
Manufactured for
Halozyme Therapeutics, Inc.
San Diego, CA 92121
by Baxter Pharmaceutical Solutions LLC
Bloomington, IN 47403

| Hylenex Recombinant hyaluronidase recombinant human injection, solution |
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| Marketing Information | |||
| Marketing Category | Application Number or Monograph Citation | Marketing Start Date | Marketing End Date |
| NDA | NDA021859 | 12/02/2005 | |
| Labeler - Baxter Healthcare Corporation (005083209) |
| Establishment | |||
| Name | Address | ID/FEI | Operations |
| Baxter Pharmaceutical Solutions, LLC | 604719430 | MANUFACTURE | |
Revised: 12/2009Baxter Healthcare Corporation
