Tylenol Cold Multi Symptom

Pronunciation: a-SEET-a-MIN-oh-fen/DEX-troe-meth-OR-fan/gwye-FEN-e-sin /FEN-il-EF-rin
Generic Name: Acetaminophen/Dextromethorphan/Guaifenesin/Phenylephrine
Brand Name: Examples include Tylenol Cold Head Congestion and Tylenol Cold Multi Symptom

Tylenol Cold Multi Symptom is used for:

Relieving pain, congestion, cough, and throat and airway irritation due to colds, flu, or hay fever. It may also be used for other conditions as determined by your doctor.

Tylenol Cold Multi Symptom is an analgesic, decongestant, cough suppressant, and expectorant combination. It works by constricting blood vessels and reducing swelling in the nasal passages, loosening mucus and lung secretions in the chest, and making coughs more productive. The analgesic and cough suppressant works in the brain to decrease pain and to help decrease the cough reflex to reduce a dry cough.

Do NOT use Tylenol Cold Multi Symptom if:

• you are allergic to any ingredient in Tylenol Cold Multi Symptom


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


• you have taken furazolidone or a monoamine oxidase (MAO) inhibitor (eg, phenelzine) within the last 14 days

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

Before using Tylenol Cold Multi Symptom:

Some medical conditions may interact with Tylenol Cold Multi Symptom. 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 a history of glaucoma, an enlarged prostate or other prostate problems, heart problems, diabetes, high blood pressure, blood vessel problems, adrenal gland problems, an overactive thyroid, seizures, stroke, liver problems, or severe kidney problems, or if you drink 3 or more drinks with alcohol per day


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


• if you smoke or have a history of addiction to alcohol

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

• Beta-blockers (eg, propranolol), catechol-O-methyltransferase (COMT) inhibitors (eg, tolcapone), furazolidone, indomethacin, isoniazid, MAO inhibitors (eg, phenelzine), or tricyclic antidepressants (eg, amitriptyline) because the risk of Tylenol Cold Multi Symptom's side effects may be increased


• Anticoagulants (eg, warfarin), digoxin, or droxidopa because the risk of side effects such as bleeding, irregular heartbeat, or heart attack may be increased


• Bromocriptine because the risk of its side effects may be increased by Tylenol Cold Multi Symptom


• Guanadrel, guanethidine, mecamylamine, methyldopa, or reserpine because their effectiveness may be decreased by Tylenol Cold Multi Symptom

This may not be a complete list of all interactions that may occur. Ask your health care provider if Tylenol Cold Multi Symptom 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 Tylenol Cold Multi Symptom:

Use Tylenol Cold Multi Symptom as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• Tylenol Cold Multi Symptom may be taken with or without food.


• Drink plenty of water while taking Tylenol Cold Multi Symptom.


• If you miss a dose of Tylenol Cold Multi Symptom, 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 Tylenol Cold Multi Symptom.

Important safety information:

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


• Do not take appetite suppressants while you use Tylenol Cold Multi Symptom unless your doctor tells you to.


• Tylenol Cold Multi Symptom contains acetaminophen, dextromethorphan, guaifenesin, and phenylephrine. Before you start any new medicine, check the label to see if it has any of these medicines in it too. If it does or if you are not sure, check with your doctor or pharmacist.


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


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


• Tylenol Cold Multi Symptom may harm your liver. Your risk may be greater if you drink alcohol while you are using Tylenol Cold Multi Symptom. Talk to your doctor before you take Tylenol Cold Multi Symptom or other fever reducers if you drink more than 3 drinks with alcohol per day.


• Tylenol Cold Multi Symptom may interfere with certain lab tests. Be sure your doctor and lab personnel know you are taking Tylenol Cold Multi Symptom.


• Tell your doctor or dentist that you take Tylenol Cold Multi Symptom before you receive any medical or dental care, emergency care, or surgery.


• Use Tylenol Cold Multi Symptom with caution in the ELDERLY; they may be more sensitive to its effects.


• Caution is advised when using Tylenol Cold Multi Symptom in CHILDREN; they may be more sensitive to its effects.


• Different brands of Tylenol Cold Multi Symptom may have different dosing instructions for CHILDREN. Follow the dosing instructions on the package labeling. If your doctor has given you instructions, follow those. If you are unsure of the dose to give a child, check with your doctor or pharmacist.


• PREGNANCY and BREAST-FEEDING: It is not known if Tylenol Cold Multi Symptom can cause harm to the fetus. If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Tylenol Cold Multi Symptom while you are pregnant. It is not known if Tylenol Cold Multi Symptom is found in breast milk. Do not breast-feed while taking Tylenol Cold Multi Symptom.

Possible side effects of Tylenol Cold Multi Symptom:

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: Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Dizziness; excitability; headache; nausea; nervousness or anxiety; trouble sleeping; weakness.

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

Severe allergic reactions (rash; hives; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); dark urine; difficulty urinating; fast or irregular heartbeat; hallucinations; seizures; severe dizziness, lightheadedness, or headache; stomach pain; tremor; yellowing of skin or eyes.

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

See also: Tylenol Cold Multi Symptom side effects (in more detail)

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately. Symptoms may include blurred vision; confusion; hallucinations; seizures; severe dizziness, lightheadedness, or headache; severe drowsiness; stomach pain; unusually fast, slow, or irregular heartbeat; vomiting; yellowing of skin or eyes.

Proper storage of Tylenol Cold Multi Symptom:

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

General information:

• If you have any questions about Tylenol Cold Multi Symptom, please talk with your doctor, pharmacist, or other health care provider.


• Tylenol Cold Multi Symptom is to be used only by the patient for whom it is prescribed. Do not share it with other people.


• If your symptoms do not improve or if they become worse, check with your doctor.


• Check with your pharmacist about how to dispose of unused medicine.

This information is a summary only. It does not contain all information about Tylenol Cold Multi Symptom. If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.

Issue Date: February 1, 2012

Database Edition 12.1.1.002

Copyright © 2012 Wolters Kluwer Health, Inc.

More Tylenol Cold Multi Symptom resources

• Tylenol Cold Multi Symptom Side Effects (in more detail)
• Tylenol Cold Multi Symptom Use in Pregnancy & Breastfeeding
• Tylenol Cold Multi Symptom Drug Interactions
• 0 Reviews for Tylenol Cold Multi Symptom - Add your own review/rating

Compare Tylenol Cold Multi Symptom with other medications

• Cold Symptoms
• Influenza

vemurafenib

Generic Name: vemurafenib (VEM ue RAF e nib)

Brand Names: Zelboraf

What is vemurafenib?

Vemurafenib is a cancer medication that interferes with the growth and spread of cancer cells in the body.

Vemurafenib is used to treat metastatic melanoma (skin cancer).

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

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

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

Before you take vemurafenib, tell your doctor if you have liver disease, an electrolyte imbalance (such as low levels of potassium or magnesium in your blood), or a personal or family history of Long QT syndrome.

Using vemurafenib may increase your risk of developing other types of skin cancer. Report any new or worsening skin lesions to your doctor right away.

There are many other drugs that can interact with vemurafenib. 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. Keep a list of all your medicines and show it to any healthcare provider who treats you.

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

You should not use vemurafenib if you are allergic to it.

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

• 
  

  liver disease;

  
  


• 
  

  a heart rhythm disorder;

  
  


• 
  

  a personal or family history of Long QT syndrome; or

  
  


• 
  

  an electrolyte imbalance (such as low levels of potassium or magnesium in your blood).

  
  

Using vemurafenib may increase your risk of developing other types of skin cancer. Report any new or worsening skin lesions to your doctor right away. FDA pregnancy category D. Do not use vemurafenib if you are pregnant. It could harm the unborn baby. Use effective birth control, and tell your doctor if you become pregnant during treatment. It is not known whether vemurafenib passes into breast milk or if it could harm a nursing baby. You should not breast-feed while you are using vemurafenib.

How should I take vemurafenib?

Before you start treatment, your doctor may perform tests to make sure vemurafenib is the best treatment for your type of skin cancer.

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

Vemurafenib is usually taken twice per day, as 2 tablets in the morning and 2 tablets in the evening. Follow your doctor's instructions.

Take this medicine with a full glass of water. You may take vemurafenib with or without food. Do not crush, chew, or break a vemurafenib tablet. Swallow it whole. To make sure this medication is helping your condition and not causing harmful effects, your skin condition will need to be checked often. Your heart function may also need to be tested with an electrocardiogram (ECG or EKG) on a regular basis. You may also need eye exams. Your cancer treatments may be delayed based on the results of these tests. Do not miss any follow-up visits to your doctor.

Your doctor may want to check your skin for several months after you stop using vemurafenib. Visit your doctor regularly.

Store at room temperature away from moisture and heat. Keep the bottle tightly closed when not in use.

See also: Vemurafenib dosage (in more detail)

What happens if I miss a dose?

Take the missed dose as soon as you remember. Skip the missed dose if your next dose is less than 4 hours away. 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.

What should I avoid while taking vemurafenib?

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

Vemurafenib side effects

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

• 
  

  severe dizziness, fainting, fast or pounding heartbeats;

  
  


• 
  

  white patches on your eyes;

  
  


• 
  

  new or worsening skin lesions; or

  
  


• 
  

  severe skin reaction -- fever, sore throat, swelling in your face or tongue, burning in your eyes, skin pain, followed by a red or purple skin rash that spreads (especially in the face or upper body) and causes blistering and peeling.

  
  

Less serious side effects may include:

• 
  

  joint pain;

  
  


• 
  

  tired feeling;

  
  


• 
  

  nausea;

  
  


• 
  

  hair loss;

  
  


• 
  

  mild rash or itching;

  
  


• 
  

  skin growths; or

  
  


• 
  

  blurred vision, increased sensitivity of your eyes to light.

  
  

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.

Vemurafenib Dosing Information

Usual Adult Dose for Melanoma - Metastatic:

960 mg orally twice a day.

What other drugs will affect vemurafenib?

Many drugs can interact with vemurafenib. Below is just a partial list. Tell your doctor if you are using:

• 
  

  a blood thinner such as warfarin (Coumadin, Jantoven);

  
  


• 
  

  cyclosporine (Gengraf, Neoral, Sandimmune), sirolimus (Rapamune) or tacrolimus (Prograf);

  
  


• 
  

  digoxin (digitalis, Lanoxin, Lanoxicaps);

  
  


• 
  

  theophylline (Elixophyllin, Theo-24, Theochron, Uniphyl);

  
  


• 
  

  ADHD medication such as Adderall, Concerta, Daytana, Metadate, Ritalin, Strattera;

  
  


• 
  

  an antibiotic such as clarithromycin (Biaxin), erythromycin (E.E.S., EryPed, Ery-Tab, Erythrocin, Pediazole), rifampin (Rifater, Rifadin, Rifamate), rifabutin (Mycobutin), rifapentine (Priftin), or telithromycin (Ketek);

  
  


• 
  

  an antidepressant such as amitriptyline (Elavil, Vanatrip, Limbitrol), desipramine (Norpramin), doxepin (Sinequan, Silenor), duloxetine (Cymbalta), fluoxetine (Prozac, Sarafem, Symbyax), nefazodone, nortriptyline (Pamelor), paroxetine (Paxil, Pexeva), sertraline (Zoloft), venlafaxine (Effexor), and others;

  
  


• 
  

  antifungal medication such as itraconazole (Sporanox), ketoconazole (Nizoral), miconazole (Oravig), or voriconazole (Vfend);

  
  


• 
  

  cancer medicine such as doxorubicin (Adriamycin, Doxil), lomustine (CeeNU), tamoxifen (Soltamox);

  
  


• 
  

  ergot medicine such as ergotamine (Ergomar, Cafergot) or dihydroergotamine (D.H.E. 45, Migranal Nasal Spray);

  
  


• 
  

  cough medicine such as dextromethorphan (Delsym, Robitussin Maximum Strength, Vicks 44, and others) or dihydrocodeine (Alahist DHC, J-Max DHC, Pancof-PD, Panlor, Trezix, Welltuss EXP, and others);

  
  


• 
  

  pain medication such as codeine (Tylenol #3), hydrocodone (Lortab, Vicodin, Vicoprofen), oxycodone (OxyContin, Combunox, Roxicodone, Percocet), or tramadol (Ultram, Ultracet);

  
  


• 
  

  heart or blood pressure medication such as betaxolol (Kerlone), captopril (Capoten), carvedilol (Coreg), labetalol (Normodyne), metoprolol (Dutoprol, Lopressor, Toprol), nicardipine (Cardene), pindolol (Visken), propranolol (Inderal), timolol (Blocadren);

  
  


• 
  

  a heart rhythm medication such as disopyramide (Norpace), flecainide (Tambocor), mexilitene (Mexitil), procainamide (Procan, Pronestyl), propafenone (Rythmol), or quinidine (Quin-G);

  
  


• 
  

  HIV/AIDS medicine such as atazanavir (Reyataz), delavirdine (Rescriptor), indinavir (Crixivan), nelfinavir (Viracept), saquinavir (Invirase), or ritonavir (Norvir, Kaletra);

  
  


• 
  

  medicine to treat psychiatric disorders, such as chlorpromazine (Thorazine), fluphenazine (Permitil), haloperidol (Haldol), pimozide (Orap), perphenazine (Trilafon), promethazine (Phenergan), risperidone (Risperdal), or thioridazine (Mellaril); or

  
  


• 
  

  seizure medication such as carbamazepine (Carbatrol, Equetro, Tegretol), divalproex (Depakote), phenobarbital (Solfoton), phenytoin (Dilantin), or valproic acid (Depakene, Stavzor).

  
  

This list is not complete and there are many other drugs that can interact with vemurafenib. 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. Keep a list of all your medicines and show it to any healthcare provider who treats you.

More vemurafenib resources

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

• vemurafenib Advanced Consumer (Micromedex) - Includes Dosage Information


• Vemurafenib Professional Patient Advice (Wolters Kluwer)


• Vemurafenib MedFacts Consumer Leaflet (Wolters Kluwer)


• Zelboraf Prescribing Information (FDA)


• Zelboraf Consumer Overview

Compare vemurafenib with other medications

• Melanoma, Metastatic

Where can I get more information?

• Your pharmacist can provide more information about vemurafenib.

See also: vemurafenib side effects (in more detail)

hyoscyamine

Generic Name: hyoscyamine (hye oh SYE a meen)

Brand names: Anaspaz, Cystospaz, Ed Spaz, HyoMax, HyoMax DT, HyoMax FT, HyoMax SL, HyoMax SR, Hyospaz, Hyosyne, IB-Stat, Levbid, Levsin, Levsin SL, Levsinex SR, NuLev, Nulev, Symax Duotab, Symax FasTab, Symax SL, Symax SR, Cystospaz-M, A-Spas S/L, Donnamar, Hyosol, Spasdel

What is hyoscyamine?

Hyoscyamine produces many effects in the body, including relief from muscle spasms.

Hyoscyamine also reduces the fluid secretions of many organs and glands in the body, such as the stomach, pancreas, lungs, saliva glands, sweat glands, and nasal passages.

Hyoscyamine is used to treat many different stomach and intestinal disorders, including peptic ulcer and irritable bowel syndrome. It is also used to control muscle spasms in the bladder, kidneys, or digestive tract, and to reduce stomach acid. Hyoscyamine is sometimes used to reduce tremors and rigid muscles in people with symptoms of Parkinson's disease.

Hyoscyamine is also used as a drying agent to control excessive salivation, runny nose, or excessive sweating.

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

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

Do not take hyoscyamine if you are allergic to it, or if you have kidney disease, a bladder or intestinal obstruction, severe ulcerative colitis, toxic megacolon, glaucoma, or myasthenia gravis.

Before taking hyoscyamine, tell your doctor if you have heart disease, congestive heart failure, a heart rhythm disorder, high blood pressure, overactive thyroid, or hiatal hernia with gastroesophageal reflux disease.

Avoid taking antacids at the same time you take hyoscyamine. Antacids can make it harder for your body to absorb hyoscyamine. If you use an antacid, take it after you have taken hyoscyamine and eaten a meal.

Hyoscyamine may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be alert. Drinking alcohol can increase drowsiness and dizziness while you are taking hyoscyamine.

Avoid becoming overheated or dehydrated during exercise and in hot weather. Hyoscyamine can decrease sweating and you may be more prone to heat stroke.

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

Do not take hyoscyamine if you are allergic to it, or if you have:

• kidney disease;


• 
  

  an enlarged prostate or problems with urination;

  
  


• 
  

  intestinal blockage;

  
  


• 
  

  severe ulcerative colitis, or toxic megacolon;

  
  


• 
  

  glaucoma; or

  
  


• 
  

  myasthenia gravis.

  
  

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

• 
  

  heart disease, congestive heart failure;

  
  


• 
  

  a heart rhythm disorder;

  
  


• 
  

  high blood pressure;

  
  


• 
  

  overactive thyroid; or

  
  


• 
  

  hiatal hernia with GERD (gastroesophageal reflux disease).

  
  

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

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

Your medication may come with patient instructions for safe and effective use. Follow these directions carefully. Ask your doctor or pharmacist if you have any questions.

Hyoscyamine is usually taken before a meal. Follow your doctor's instructions.

Do not crush, chew, or open an extended-release tablet or capsule. It is specially made to release medicine slowly in the body. Breaking or crushing the pill would cause too much of the drug to be released at one time. Your doctor may want you to break an extended-release tablet and take only half of it. Follow your doctor's instructions.

Measure the oral liquid form of hyoscyamine 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.

The sublingual tablet form of this medication must be placed under the tongue, where it will dissolve. Do not swallow the sublingual tablet whole or wash it down with water. You may drink water after the pill has completely dissolved in your mouth.

Before using hyoscyamine oral spray for the first time, you must prime the spray pump. To do this, spray 3 test sprays into the air and away from your face. Prime the spray pump at least 1 test spray any time you have not used the oral spray for longer than 2 days. Spray until a fine mist appears.

After using the oral spray, try not to swallow right away. Do not rinse your mouth or spit for 5 to 10 minutes after using the oral spray.

Store this medication at room temperature away from moisture and heat.

Do not use hyoscyamine oral spray for more than 30 sprays, even if there is medicine still left in the bottle.

See also: Hyoscyamine dosage (in more detail)

What happens if I miss a dose?

Take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.

What happens if I overdose?

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

Overdose symptoms may include headache, dizziness, dry mouth, trouble swallowing, nausea, vomiting, blurred vision, hot dry skin, and feeling restless or nervous.

What should I avoid while taking hyoscyamine?

Avoid taking antacids at the same time you take hyoscyamine. Antacids can make it harder for your body to absorb hyoscyamine. If you use an antacid, take it after you have taken hyoscyamine and eaten a meal.

Hyoscyamine may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be alert. Drinking alcohol can increase drowsiness and dizziness while you are taking hyoscyamine.

Avoid becoming overheated or dehydrated during exercise and in hot weather. Hyoscyamine can decrease sweating and you may be more prone to heat stroke.

Hyoscyamine side effects

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

• 
  

  diarrhea;

  
  


• 
  

  confusion, hallucinations;

  
  


• 
  

  unusual thoughts or behavior;

  
  


• 
  

  fast, pounding, or uneven heart rate;

  
  


• 
  

  rash or flushing (warmth, redness, or tingly feeling); or

  
  


• 
  

  eye pain.

  
  

Less serious side effects may include:

• 
  

  dizziness, drowsiness, feeling nervous;

  
  


• 
  

  blurred vision, headache;

  
  


• 
  

  sleep problems (insomnia);

  
  


• 
  

  nausea, vomiting, bloating, heartburn, or constipation;

  
  


• 
  

  changes in taste;

  
  


• 
  

  problems with urination;

  
  


• 
  

  decreased sweating;

  
  


• 
  

  dry mouth; or

  
  


• 
  

  impotence, loss of interest in sex, or trouble having an orgasm.

  
  

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Hyoscyamine Dosing Information

Usual Adult Dose for Irritable Bowel Syndrome:

Immediate-release Tablets: 0.125 to 0.25 mg orally or sublingually every 4 hours or as needed. Do not take more than 12 tablets in 24 hours.

Extended-release Tablets: 0.375 to 0.75 mg orally every 12 hours. Do not exceed 4 tablets in 24 hours.

Timecaps: 0.375 to 0.75 mg orally every 12 hours. Do not exceed 4 capsules in 24 hours

Biphasic tablets: 0.375 to 0.75 mg orally every 12 hours. Dosage may be adjusted to 0.375 mg every 8 hours if needed. Do not exceed 4 tablets in 24 hours.

Elixir: 5 to 10 mL (0.125 to 0.25 mg) every 4 hours or as needed. Do not take more than 12 teaspoonfuls in 24 hours.

Drops: 1 to 2 mL (0.125 to 0.25 mg) every 4 hours as needed. Do not take more than 12 mL in 24 hours.

Usual Adult Dose for Anesthesia:

5 mcg/kg administered 30 to 60 minutes prior to the time of induction of anesthesia or given at the time the preanesthetic narcotic or sedative are administered.

Usual Adult Dose for Endoscopy or Radiology Premedication:

Parenteral:
0.25 to 0.5 mg (0.5 to 1 mL) IV 5 to 10 minutes prior to the diagnostic procedure.

Oral Spray:
Endoscopic retrograde cholangiopancreatography: 2 sprays (0.25 mg) 20 minutes prior to the procedure.

Usual Pediatric Dose for Urinary Incontinence:

Greater than or equal to 2 to less than 12 years:
Immediate-release Tablets: 0.0625 to 0.125 mg sublingually, orally, chew, every 4 hours or as needed. Do not take more than 6 tablets in 24 hours.

Elixir: 1.25 to 5 mL (10 kg to 50 kg child) every 4 hours or as needed. Increase dose by 1.25 mL increments for a 20 kg child, and again for a 40 kg child. Do not take more than 6 teaspoonfuls in 24 hours.

Drops: 0.25 to 1 mL (0.0312 to 0.125 mg) every 4 hours as needed. Do not give more than 6 mL in 24 hours.

Biphasic tablets: 0.375 mg orally every 12 hours. Do not exceed 2 tablets in 24 hours.

Less than 2 years:
Drops: 4 drops for a 3.4 kg child (Do not give more than 24 drops in 24 hours)
5 drops for a 5 kg child (Do not give more than 30 drops in 24 hours),
6 drops for a 7 kg child (Do not give more than 36 drops in 24 hours),
8 drops for a 10 kg child (Do not give more than 48 drops in 24 hours)

Usual Pediatric Dose for Irritable Bowel Syndrome:

Study (n=28)
Greater than 9 years: 0.375 mg orally at bedtime, up to 0.75 mg, for up to 6 months.

Usual Pediatric Dose for Anesthesia:

5 mcg/kg administered 30 to 60 minutes prior to the time of induction of anesthesia or given at the time the preanesthetic narcotic or sedative are administered.

What other drugs will affect hyoscyamine?

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

• 
  

  amantadine (Symmetrel);

  
  


• 
  

  haloperidol (Haldol);

  
  


• 
  

  an MAO inhibitor such as furazolidone (Furoxone), isocarboxazid (Marplan), phenelzine (Nardil), rasagiline (Azilect), selegiline (Eldepryl, Emsam), or tranylcypromine (Parnate);

  
  


• 
  

  phenothiazines such as chlorpromazine (Thorazine), fluphenazine (Permitil, Prolixin), perphenazine (Trilafon), prochlorperazine (Compazine, Compro), promethazine (Pentazine, Phenergan, Anergan, Antinaus), thioridazine (Mellaril), or trifluoperazine (Stelazine); or

  
  


• 
  

  an antidepressant such as amitriptyline (Elavil, Vanatrip), doxepin (Sinequan), desipramine (Norpramin), imipramine (Janimine, Tofranil), nortriptyline (Pamelor), and others.

  
  

This list is not complete and other drugs may interact with hyoscyamine. Tell your doctor about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal products. Do not start a new medication without telling your doctor.

More hyoscyamine resources

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

• Hyoscyamine Monograph (AHFS DI)


• Hyoscyamine MedFacts Consumer Leaflet (Wolters Kluwer)


• Anaspaz MedFacts Consumer Leaflet (Wolters Kluwer)


• HyoMax Prescribing Information (FDA)


• Hyosyne Drops MedFacts Consumer Leaflet (Wolters Kluwer)


• Hyosyne Prescribing Information (FDA)


• IB-Stat Spray MedFacts Consumer Leaflet (Wolters Kluwer)


• Levbid Extended-Release Tablets MedFacts Consumer Leaflet (Wolters Kluwer)


• Levsin Prescribing Information (FDA)


• NuLev Orally Disintegrating Tablets MedFacts Consumer Leaflet (Wolters Kluwer)


• Symax Duotab Controlled-Release Tablets MedFacts Consumer Leaflet (Wolters Kluwer)

Compare hyoscyamine with other medications

• Anesthesia
• Crohn's Disease
• Endoscopy or Radiology Premedication
• Irritable Bowel Syndrome
• Urinary Incontinence

Where can I get more information?

• Your pharmacist can provide more information about hyoscyamine.

See also: hyoscyamine side effects (in more detail)

Methenamine

Class: Urinary Anti-infectives
Note: This monograph also contains information on Methenamine Hippurate, Methenamine Mandelate
VA Class: AM550
CAS Number: 100-97-0
Brands: Hiprex, Mandelamine, Urex

Introduction

Antibacterial.^{100 101 102}

Uses for Methenamine

Urinary Tract Infections (UTIs)

Prophylaxis or suppression of recurrent UTIs (bacteriuria), especially when long-term therapy is considered necessary.^{100 101 102}

Use only after UTI has been eradicated by other appropriate anti-infectives.^{100 101}

Not effective in systemic bacterial infections and has no effect on bacteria in blood or tissues outside the urinary tract.^a Do not use alone in the treatment of acute parenchymal infections causing systemic symptoms (e.g., chills, fever).^{100 102}

Monitor efficacy by periodic urine cultures.^{100 101}

Antibacterial effects are maximal when urine pH is ≤5.5.¹⁰² Monitor urinary pH during therapy; use supplementary acidification, if required.^{101 102} Supplementary acidification may be achieved by dietary regulation and/or concomitant administration of acidifying agents (e.g., ammonium chloride, ascorbic acid, methionine).^a This is particularly important when the causative organisms are urea-splitting strains of Proteus or Pseudomonas which increase urinary pH.^{100 101}

Methenamine Dosage and Administration

General

• 
  

  Acidic urine is essential for antibacterial activity; maximum efficacy occurs when urine pH is ≤5.5.¹⁰² Restrict alkalinizing food and medication;^{101 102} use supplemental acidification if needed.^{100 101 102 a}

  
  

Administration

Oral Administration

Administer orally.^{100 101 102}

Dosage

Available as methenamine hippurate and methenamine mandelate; dosage expressed in terms of the salt.^{100 101 102}

Pediatric Patients

Prophylaxis or Suppression of Urinary Tract Infections (UTIs)

Methenamine Hippurate

Oral

Children <6 years of age: Dosage not established.^a

Children 6–12 years of age: 500 mg to 1 g twice daily (morning and night).^{100 101}

Children >12 years of age: 1 g twice daily (morning and night).^{100 101}

Methenamine Mandelate

Oral

Children <6 years of age: 18.4 mg/kg 4 times daily, (after meals and at bedtime).¹⁰²

Children 6–12 years of age: 500 mg 4 times daily (after meals and at bedtime).¹⁰²

Children >12 years of age: 1 g 4 times daily (after meals and at bedtime).¹⁰²

Alternatively, some clinicians recommend 50 mg/kg daily in 3 divided doses for children.^a

Adults

Prophylaxis or Suppression of Urinary Tract Infections (UTIs)

Methenamine Hippurate

Oral

1 g twice daily (morning and night).^{100 101}

Methenamine Mandelate

Oral

1 g 4 times daily (after meals and at bedtime).¹⁰²

Special Populations

No special population dosage recommendations at this time.^{100 101 102}

Cautions for Methenamine

Contraindications

• 
  

  Known hypersensitivity to the drug.¹⁰²

  
  


• 
  

  Renal insufficiency.^{100 101 102}

  
  


• 
  

  Severe hepatic insufficiency^{100 101} or severe dehydration.^{100 101}

  
  

Warnings/Precautions

Warnings

Dysuria

Large doses (8 g daily for 3–4 weeks) have caused bladder irritation, painful and frequent micturition, albuminuria, and gross hematuria.^{100 101}

Dysuria may be controlled by reducing dosage and/or reducing urine acidification.¹⁰²

Hepatic Effects

Patients with preexisting hepatic insufficiency may have adverse effects from the small amounts of ammonia and formaldehyde that are produced following administration of methenamine.¹⁰⁰ Acute hepatic failure may occur in some patients.¹⁰⁰

Transient elevations in serum AST and ALT concentrations have occurred in patients receiving methenamine hippurate.^{100 101}

Perform periodic liver function tests in patients receiving methenamine hippurate, especially in those with hepatic impairment.^{100 101} (See Hepatic Impairment under Cautions.)

Sensitivity Reactions

Tartrazine Sensitivity

Hiprex tablets contain tartrazine (FD&C yellow No. 5), which may cause allergic reactions, including bronchial asthma, in susceptible individuals.¹⁰¹ Incidence of tartrazine sensitivity is low, but it frequently occurs in patients who are sensitive to aspirin.¹⁰¹

General Precautions

Acidic Urine

Ensure that urine is maintained at an acidic pH during treatment, especially when causative organisms are urea-splitting strains of Proteus or Pseudomonas.^{100 101} (See Dosage and Administration.)

Manufacturer of methenamine mandelate states the drug is not recommended if urine acidification is contraindicated or unattainable (e.g., when some urea-splitting bacteria are present).¹⁰²

Selection and Use of Anti-infectives

To reduce development of drug-resistant bacteria and maintain effectiveness of methenamine and other antibacterials, use only to prevent infections proven or strongly suspected to be caused by susceptible bacteria.¹⁰¹

When selecting or modifying anti-infective therapy, use results of culture and in vitro susceptibility testing.¹⁰¹ In the absence of such data, consider local epidemiology and susceptibility patterns when selecting anti-infectives for empiric therapy.¹⁰¹

Specific Populations

Pregnancy

Category C.^{100 102}

One manufacturer of methenamine hippurate states that safety during the last trimester is suggested, but not definitely proven.¹⁰¹

Effects of methenamine during labor and delivery are unknown and there are no recognized uses for the drug during labor or delivery.¹⁰⁰

Lactation

Distributed into milk; discontinue nursing or the drug.¹⁰⁰

Pediatric Use

Has been used in children without unusual toxicity.¹⁰⁰

Geriatric Use

Insufficient experience in patients ≥65 years of age to determine whether they respond differently than younger adults; clinical experience has not identified differences.¹⁰¹

Select dosage with caution, usually starting at the low end of the dosage range, because of possible age-related decreases in hepatic, renal, and/or cardiac function and concomitant disease and drug therapy.¹⁰¹

Hepatic Impairment

Perform periodic liver function tests.^{100 101}

Methenamine hippurate is contraindicated in those with severe hepatic insufficiency.^{100 101}

Common Adverse Effects

GI disturbances (nausea, vomiting, diarrhea, abdominal cramps, anorexia), pruritus, rash, dysuria.^{100 101 102 a}

Interactions for Methenamine

Specific Drugs and Laboratory Tests

Drug or Test	Interaction	Comments
Sulfonamides	Insoluble precipitate forms in urine between formaldehyde and some sulfonamides (e.g., sulfamethizole, sulfathiazole [not commercially available in the US])100 101 102	Avoid concomitant use100 101 102
Test for 17-hydroxycorticosteroid	Formaldehyde in urine causes falsely elevated concentrations when Porter-Silber method is used102
Test for 5-hydroxyindoleacetic acid (5HIAA)	Formaldehyde in urine causes falsely decreased concentrations when nitrosonaphthol methods are used102
Test for urinary catecholamines and vanillylmandelic acid (VMA)	Formaldehyde in urine causes erroneously high results when fluorometric procedures are used102
Test for urine estriol	Formaldehyde in urine causes falsely decreased urine estriol concentrations when acid hydrolysis techniques are used101 102	Enzymatic hydrolysis technique unaffected101 102

Methenamine Pharmacokinetics

Absorption

Bioavailability

Readily absorbed from the GI tract.^a About 10–30% of oral dose is hydrolyzed by gastric acidity to formaldehyde and ammonia.^a Enteric coating of methenamine mandelate tablets reduces hydrolysis in the GI tract and rate of absorption.^a

Plasma Concentrations

Following oral administration of a usual single dose to healthy fasting adults, concentrations of methenamine and formaldehyde in plasma are generally very low and antibacterial activity in plasma is negligible.^a

Distribution

Extent

Crosses the placenta.¹⁰⁰

Distributed into milk.¹⁰⁰

Elimination

Elimination Route

Within 24 hours, ≥70–90% of a single oral dose is excreted intact in the urine by glomerular filtration and tubular secretion.^a When urine is acidic, methenamine is hydrolyzed to formaldehyde and ammonia; maximum hydrolysis occurs when urine pH is ≤5.5.^a

Mandelic acid (mandelate) and hippuric acid (hippurate) are excreted in urine by glomerular filtration and tubular excretion.^{101 102}

Stability

Storage

Oral

Tablets

15–30°C^{100 101 102} in tight, light resistant containers.¹⁰²

Actions and SpectrumActions

• 
  

  Synthetic antibacterial agent chemically unrelated to other currently available anti-infectives.^a

  
  


• 
  

  Antibacterial effect of methenamine hippurate or methenamine mandelate depends on conversion of methenamine to formaldehyde in an acid medium (acidic urine).^a

  
  


• 
  

  Formaldehyde is a nonspecific antibacterial agent which is usually bactericidal in action.^a The acid portions of methenamine salts (hippuric acid, mandelic acid) have some nonspecific antibacterial activity and may enhance the liberation of formaldehyde from methenamine in vivo by maintaining urinary acidity.^a

  
  


• 
  

  Formaldehyde is active against both gram-positive and gram-negative bacteria including Enterobacter, Escherichia coli, Klebsiella, Proteus, Pseudomonas aeruginosa, Staphylococcus aureus, S. epidermidis, and Enterococcus faecalis (formerly Streptococcus faecalis).^a

  
  


• 
  

  Because formaldehyde, hippuric acid, and mandelic acid have nonspecific antibacterial activity, resistance does not usually develop during prolonged therapy with methenamine hippurate or methenamine mandelate.^a

  
  

Advice to Patients

• 
  

  Advise patients that antibacterials (including methenamine hippurate and methenamine mandelate) should only be used for bacterial infections and not used to treat viral infections (e.g., the common cold).¹⁰¹

  
  


• 
  

  Importance of completing full course of therapy, even if feeling better after a few days.¹⁰¹

  
  


• 
  

  Advise patients that skipping doses or not completing the full course of therapy may decrease effectiveness and increase the likelihood that bacteria will develop resistance and will not be treatable with methenamine or other antibacterials in the future.¹⁰¹

  
  


• 
  

  Importance of informing clinicians of existing or contemplated concomitant therapy, including prescription and OTC drugs or laboratory tests.^{100 101 102}

  
  


• 
  

  Importance of women informing clinicians if they are or plan to become pregnant or plan to breast-feed.^{100 101 102}

  
  


• 
  

  Importance of informing patients of other important precautionary information.^{100 101 102} (See Cautions.)

  
  

Preparations

Excipients in commercially available drug preparations may have clinically important effects in some individuals; consult specific product labeling for details.

* available from one or more manufacturer, distributor, and/or repackager by generic (nonproprietary) name

Methenamine Hippurate

Routes	Dosage Forms	Strengths	Brand Names	Manufacturer
Oral	Tablets	1 g*	Hiprex (with povidone and tartrazine; scored)	Sanofi-Aventis
			Methenamine Hippurate Tablets	Corepharma
			Urex (with povidone; scored)	Vatring

Methenamine Mandelate

Routes	Dosage Forms	Strengths	Brand Names	Manufacturer
Oral	Tablets, film-coated	500 mg	Mandelamine Hafgrams (with povidone and polyethylene glycol)	Warner Chilcott
		1 g	Mandelamine (with povidone and polyethylene glycol)	Warner Chilcott

Comparative Pricing

This pricing information is subject to change at the sole discretion of DS Pharmacy. This pricing information was updated 04/2011. Actual costs to patients will vary depending on the use of specific retail or mail-order locations and health insurance copays.

Hiprex 1GM Tablets (SANOFI-AVENTIS U.S.): 20/$49.99 or 60/$139.97

Methenamine Hippurate 1GM Tablets (COREPHARMA LLC): 100/$185.99 or 300/$535.99

Urex 1GM Tablets (VATRING PHARMACEUTICALS): 30/$68.99 or 90/$199.97

Disclaimer

This report on medications is for your information only, and is not considered individual patient advice. Because of the changing nature of drug information, please consult your physician or pharmacist about specific clinical use.

The American Society of Health-System Pharmacists, Inc. and Drugs.com represent that the information provided hereunder was formulated with a reasonable standard of care, and in conformity with professional standards in the field. The American Society of Health-System Pharmacists, Inc. and Drugs.com make no representations or warranties, express or implied, including, but not limited to, any implied warranty of merchantability and/or fitness for a particular purpose, with respect to such information and specifically disclaims all such warranties. Users are advised that decisions regarding drug therapy are complex medical decisions requiring the independent, informed decision of an appropriate health care professional, and the information is provided for informational purposes only. The entire monograph for a drug should be reviewed for a thorough understanding of the drug's actions, uses and side effects. The American Society of Health-System Pharmacists, Inc. and Drugs.com do not endorse or recommend the use of any drug. The information is not a substitute for medical care.

AHFS Drug Information. © Copyright, 1959-2011, Selected Revisions January 01, 2008. American Society of Health-System Pharmacists, Inc., 7272 Wisconsin Avenue, Bethesda, Maryland 20814.

References

100. Vatring. Urex (methenamine hippurate) prescribing information. Wytheville, VA; 2004 Aug.

101. Sanofi-Aventis. Hiprex (methenamine hippurate) prescribing information. Bridgewater, NJ; 2006 Mar.

102. Warner Chilcott. Mandelamine (methenamine mandelate) prescribing information. Rockaway, NJ; 2006 Oct.

a. AHFS Drug Information 2007. McEvoy GK, ed. Methenamine. Bethesda, MD: American Society of Health-System Pharmacists; 2007:889-90.

More Methenamine resources

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

• Methenamine Prescribing Information (FDA)


• Methenamine MedFacts Consumer Leaflet (Wolters Kluwer)


• methenamine Concise Consumer Information (Cerner Multum)


• methenamine Advanced Consumer (Micromedex) - Includes Dosage Information


• Hiprex Prescribing Information (FDA)

Compare Methenamine with other medications

• Bladder Infection
• Prevention of Bladder infection

CD33 monoclonal antibodies

A drug may be classified by the chemical type of the active ingredient or by the way it is used to treat a particular condition. Each drug can be classified into one or more drug classes.

Monoclonal antibodies used in immunotherapy are produced artificially from a cell clone therefore consist of a single type of immunoglobulin. They are targeted towards specific antigens and bind to the antigens to form a complex. These complexes can be recognized and destroyed by phagocytes or used for other diagnostic purposes.

Natural antibodies are proteins made by the B-lymphocytes in response to antigens. Each B-cell makes only one type of antibody. For therapeutic purposes a significant amount of a particular antibody is needed. These are obtained from a culture that gives a one type of antibody, which are called monoclonal antibodies.

CD33 is an antigen present on granulocyte and macrophage precursors in the bone marrow. It differentiates myelogenous leukemia cells from lymphoid or erythroid leukemias.

CD33 monoclonal antibodies are administered with other chemotherapy agents, such as cytosine arabinoside and idarubicin, to enhance the cytotoxic effects on acute myeloid leukemia (AML) cells.

See also

Medical conditions associated with CD33 monoclonal antibodies:

• Acute Myeloid Leukemia

Drug List:

Mylotarg

AK-Pentolate

cyclopentolate hydrochloride

Dosage Form: ophthalmic solution

Rx only

AK-Pentolate Description

AK-Pentolate™ (Cyclopentolate Hydrochloride Ophthalmic Solution) is an anticholinergic prepared as a sterile, borate buffered solution for topical ocular use. It is supplied in two strengths.

Chemical name:

2-(Dimethylamino)ethyl 1-hydroxy-α-phenylcyclopentaneacetate hydrochloride

MW=327.85            C17H25NO3 • HCl

The active ingredient is represented by the structural formula:

AK-Pentolate™ (Cyclopentolate Hydrochloride Ophthalmic Solution) USP, 1% & 2%

Each mL contains: Active: Cyclopentolate Hydrochloride 10 mg (1%) or 20 mg (2%).

Preservative: Benzalkonium Chloride 0.1 mg (0.01%).

Inactives: Boric Acid, Edetate Disodium, Potassium Chloride (except 2% strength), Sodium Carbonate and/or Hydrochloric Acid may be added to adjust pH (3.0 to 5.5) and Purified Water USP.

AK-Pentolate - Clinical Pharmacology

This anticholinergic preparation blocks the responses of the sphincter muscle of the iris and the accommodative muscle of the ciliary body to cholinergic stimulation, producing pupillary dilation (mydriasis) and paralysis of accommodation (cycloplegia). It acts rapidly, but has a shorter duration than atropine. Maximal cycloplegia occurs within 25 to 75 minutes after instillation. Complete recovery of accommodation usually takes 6 to 24 hours. Complete recovery from mydriasis in some individuals may require several days. Heavily pigmented irides may require more doses than lightly pigmented irides.

Indications and Usage for AK-Pentolate

Cyclopentolate hydrochloride ophthalmic solution is used to produce mydriasis and cycloplegia.

Contraindications

AK-Pentolate™ (Cyclopentolate Hydrochloride Ophthalmic Solution) should not be used when untreated narrow-angle glaucoma, or untreated anatomically narrow angles are present, or if the patient is hypersensitive to any component of this preparation.

Warnings

For topical ophthalmic use only. Not for injection. This preparation may cause CNS disturbances. This is especially true in younger age groups, but may occur at any age, especially with the stronger solutions. Infants are especially prone to CNS and cardiopulmonary side effects from cyclopentolate. To minimize absorption, use only 1 drop of 0.5% cyclopentolate hydrochloride ophthalmic solution per eye, followed by pressure applied over the nasolacrimal sac for two to three minutes. Observe infants closely for at least 30 minutes.

Mydriatics may produce a transient elevation of intraocular pressure.

Precautions

General

The lacrimal sac should be compressed by digital pressure for two to three minutes after instillation to reduce excessive systemic absorption. Caution should be observed when considering use of this medication in the presence of Down's syndrome and in those predisposed to angle-closure glaucoma.

Information for Patients

Do not touch dropper tip to any surface, as this may contaminate the solution. A transient burning sensation may occur upon instillation. Patients should be advised not to drive or engage in other hazardous activities while pupils are dilated. Patients may experience sensitivity to light and should protect eyes in bright illumination during dilation. Parents should be warned not to get this preparation in their child's mouth and to wash their own hands and the child's hands following administration. Feeding intolerance may follow ophthalmic use of this product in infants. It is recommended that feeding be withheld for four (4) hours after examination.

Drug Interactions

Cyclopentolate may interfere with the ocular anti-hypertensive action of carbachol, pilocarpine, or ophthalmic cholinesterase inhibitors.

Carcinogenesis, Mutagenesis, and Impairment of Fertility

Studies in animals or humans have not been conducted to evaluate the carcinogenic potential of cyclopentolate.

Pregnancy

Pregnancy Category C

Animal reproduction studies have not been conducted with cyclopentolate. It is also not known whether cyclopentolate can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Cyclopentolate should be administered to a pregnant woman only if clearly needed.

Nursing Mothers

It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when cyclopentolate hydrochloride is administered to a nursing woman.

Pediatric Use

Use of cyclopentolate has been associated with psychotic reactions and behavioral disturbances in pediatric patients. Increased susceptibility to cyclopentolate has been reported in infants, young children, and in children with spastic paralysis or brain damage. These disturbances include ataxia, incoherent speech, restlessness, hallucinations, hyperactivity, seizures, disorientation as to time and place, and failure to recognize people. Feeding intolerance may follow ophthalmic use of this product in infants. It is recommended that feeding be withheld for four (4) hours after examination. Observe infants closely for at least 30 minutes (see WARNINGS).

Adverse Reactions

Ocular: Increased intraocular pressure, burning, photophobia, blurred vision, irritation, hyperemia, conjunctivitis, blepharoconjunctivitis, punctate keratitis, synechiae have been reported. Non-ocular: Use of cyclopentolate has been associated with psychotic reactions and behavioral disturbances, usually in children, especially with 2% concentration. These disturbances include ataxia, incoherent speech, restlessness, hallucinations, hyperactivity, seizures, disorientation as to time and place, and failure to recognize people. This drug produces reactions similar to those of other anticholinergic drugs, but the central nervous system manifestations as noted above are more common. Other manifestations of anticholinergic drugs are skin rash, abdominal distention in infants, unusual drowsiness, tachycardia, hyperpyrexia, vasodilation, urinary retention, diminished gastrointestinal motility and decreased secretion in salivary and sweat glands, pharynx, bronchi and nasal passages. Severe manifestations of toxicity include coma, medullary paralysis and death.

Overdosage

Excessive dosage may produce behavioral disturbances, tachycardia, hyperpyrexia, hypertension, elevated intraocular pressure, vasodilation, urinary retention, diminished gastrointestinal motility and decreased secretion in salivary and sweat glands, pharynx, bronchi and nasal passages. Patients exhibiting signs of overdosage should receive supportive care and monitoring.

AK-Pentolate Dosage and Administration

Adults: Instill one or two drops of 1% or 2% solution in the eye which may be repeated in five to ten minutes if necessary. Complete recovery usually occurs in 24 hours. Complete recovery from mydriasis in some individuals may require several days. Children: Instill one or two drops of 1% or 2% solution in the eye which may be repeated five to ten minutes later by a second application of 1% solution if necessary.

How is AK-Pentolate Supplied

AK-Pentolate™ (Cyclopentolate Hydrochloride Ophthalmic Solution, USP) is a sterile ophthalmic solution supplied in white opaque plastic dropper bottles as follows:

AK-Pentolate™ (Cyclopentolate Hydrochloride Ophthalmic Solution USP, 1%)

  2 mL NDC 17478-100-20

  5 mL NDC 17478-100-10

15 mL NDC 17478-100-12

AK-Pentolate™ (Cyclopentolate Hydrochloride Ophthalmic Solution USP, 2%)

  2 mL NDC 17478-097-20

  5 mL NDC 17478-097-10

15 mL NDC 17478-097-12

DO NOT USE IF IMPRINTED SEAL IS BROKEN OR MISSING.

Storage

Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Keep tightly closed.

KEEP OUT OF THE REACH OF CHILDREN.

Akorn

Lake Forest, IL 60045

CP00N

Revised 05/08

AK-Pentolate  cyclopentolate hydrochloride  solution/ drops

Product Information Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 17478-100 Route of Administration OPHTHALMIC DEA Schedule

INGREDIENTS Name (Active Moiety) Type Strength Cyclopentolate Hydrochloride (Cyclopentolate) Active 10 MILLIGRAM  In 1 MILLILITER Benzalkonium Chloride Inactive 0.1 MILLIGRAM  In 1 MILLILITER Boric Acid Inactive   Edetate Disodium Inactive   Potassium Chloride Inactive   Sodium Carbonate Inactive   Hydrochloric Acid Inactive   Water Inactive

Product Characteristics Color      Score      Shape Size Flavor Imprint Code Contains

Packaging # NDC Package Description Multilevel Packaging 1 17478-100-20 2 mL (MILLILITER) In 1 BOTTLE, DROPPER None 2 17478-100-10 5 mL (MILLILITER) In 1 BOTTLE, DROPPER None 3 17478-100-12 15 mL (MILLILITER) In 1 BOTTLE, DROPPER None

AK-Pentolate  cyclopentolate hydrochloride  solution/ drops

Product Information Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 17478-097 Route of Administration OPHTHALMIC DEA Schedule

INGREDIENTS Name (Active Moiety) Type Strength Cyclopentolate Hydrochloride (Cyclopentolate) Active 20 MILLIGRAM  In 1 MILLILITER Benzalkonium Chloride Inactive 0.1 MILLIGRAM  In 1 MILLILITER Boric Acid Inactive   Edetate Disodium Inactive   Sodium Carbonate Inactive   Hydrochloric Acid Inactive   Water Inactive

Product Characteristics Color      Score      Shape Size Flavor Imprint Code Contains

Packaging # NDC Package Description Multilevel Packaging 1 17478-097-20 2 mL (MILLILITER) In 1 BOTTLE, DROPPER None 2 17478-097-10 5 mL (MILLILITER) In 1 BOTTLE, DROPPER None 3 17478-097-12 15 mL (MILLILITER) In 1 BOTTLE, DROPPER None

Revised: 03/2009Akorn, Inc.

More AK-Pentolate resources

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

• AK-Pentolate Concise Consumer Information (Cerner Multum)


• AK-Pentolate Ophthalmic Advanced Consumer (Micromedex) - Includes Dosage Information


• Ak-Pentolate MedFacts Consumer Leaflet (Wolters Kluwer)


• Cylate Advanced Consumer (Micromedex) - Includes Dosage Information

Compare AK-Pentolate with other medications

• Pupillary Dilation
• Refraction, Assessment
• Uveitis

Ex-Lax Senna Pills

1. Name Of The Medicinal Product

EX-LAX ^® SENNA PILLS

2. Qualitative And Quantitative Composition

Each tablet contains senna glycosides 60% 20 mg

(equivalent to sennosides 12 mg)

For excipients see section 6.1

3. Pharmaceutical Form

Coated tablets

Circular , biconvex, brownish red sugar coated tablets with approx. 6mm diameter

4. Clinical Particulars

4.1 Therapeutic Indications

Relief of constipation

4.2 Posology And Method Of Administration

The following doses are normally taken at bedtime

Adults and children over 12: 1 tablet

A second dose may be taken during the day if required. Do not exceed two doses in any 24 hours.

Not recommended for children under 12.

There is no indication that the dosage should be modified for the elderly.

Route:

Oral route of administration.

4.3 Contraindications

Ex-Lax Senna Pills should not be used when intestinal obstruction, bleeding or persistent abdominal symptoms are present.

Not recommended in cases of ileostomy or colostomy.

4.4 Special Warnings And Precautions For Use

Prolonged use is not recommended. Ex-Lax Senna Pills should not be used for more than 7 days without seeking medical advice.

Label/leaflet precaution:

If a laxative is needed every day or there is persistent abdominal pain - consult your doctor. If there is no bowel movement after 3 days consult your doctor.

If a laxative is needed every day or there is persistent abdominal pain - consult your doctor.

If there is no bowel movement after 3 days consult your doctor.

Ex-Lax Senna Pills should be used with caution shortly after bowel surgery.

During use of Ex-Lax Senna Pills, an adequate level of fluid intake should be maintained.

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

None stated.

4.6 Pregnancy And Lactation

No known adverse effects during pregnancy.

Clinical studies have shown that the breast fed infants of mothers taking a senna laxative did not show any side effects to the drug.

4.7 Effects On Ability To Drive And Use Machines

None known.

4.8 Undesirable Effects

Temporary mild griping may occur.

4.9 Overdose

Overdosage may result in diarrhoea with excessive loss of water and electrolytes, particularly potassium. Treatment should include an increase in fluid intake to reverse the loss of fluid and electrolytes.

Prolonged, excessive use of laxatives without interruption should be avoided because of the risk of electrolyte imbalances and in extreme cases the possibility of irreversible adverse effects on the bowel.

5. Pharmacological Properties

5.1 Pharmacodynamic Properties

Senna is an anthraquinone laxative which is used to treat constipation and for bowel evacuation before radiological procedures. The active anthraquinones are liberated into the colon from glycosides by colonic bacteria and an effect usually occurs 6 to 12 hours after administration.

5.2 Pharmacokinetic Properties

There is some absorption of the anthraquinones from senna preparations following hydrolysis by colonic bacteria. Excretion occurs in the urine and faeces and also in other secretions including milk.

(Although anthraquinone derivatives may be excreted in the milk of lactating mothers, following normal dosage the concentration is usually insufficient to affect the nursing infant).

5.3 Preclinical Safety Data

Not applicable.

6. Pharmaceutical Particulars

6.1 List Of Excipients

Sucrose, lactose monohydrate, maize starch, talc, acacia, titanium dioxide, glucose, stearic acid, gelatin, silica colloidal anhydrous, red iron oxide, carnauba wax

6.2 Incompatibilities

None known.

6.3 Shelf Life

36 months

6.4 Special Precautions For Storage

Do not store above 25°C

6.5 Nature And Contents Of Container

Blister pack composed of PVC/PVdC blisters sealed with aluminium foil.

Pack sizes: 6, 9, 10, 12, 18, 20, 24, 30, 36, 40 or 48 tablets.

6.6 Special Precautions For Disposal And Other Handling

Not applicable.

7. Marketing Authorisation Holder

Novartis Consumer Health UK Ltd

Wimblehurst Road

Horsham

West Sussex

RH12 5AB

Trading as Novartis Consumer Health

8. Marketing Authorisation Number(S)

PL 00030/0148

9. Date Of First Authorisation/Renewal Of The Authorisation

3 November 2000

10. Date Of Revision Of The Text

8 February 2006

Legal category: GSL