Orphengesic

Generic Name: orphenadrine, aspirin, and caffeine (Oral route)

or-FEN-a-dreen SIT-rate, AS-pir-in, KAF-een

Commonly used brand name(s)

In the U.S.

• Norgesic


• Norgesic Forte


• Orphenadrine w/A.C.


• Orphengesic


• Orphengesic Forte

Available Dosage Forms:

• Tablet

Therapeutic Class: Skeletal Muscle Relaxant, Centrally Acting/Salicylate, Aspirin Combination

Pharmacologic Class: Orphenadrine

Chemical Class: Salicylate, Aspirin

Uses For Orphengesic

Orphenadrine and aspirin combination is used to help relax certain muscles in your body and relieve the pain and discomfort caused by strains, sprains, or other injury to your muscles. However, this medicine does not take the place of rest, exercise, or other treatment that your doctor may recommend for your medical problem.

Orphenadrine acts in the central nervous system (CNS) to produce its muscle relaxant effects. Actions in the CNS may also be responsible for some of its side effects. Orphenadrine also has other actions (antimuscarinic) that may be responsible for some of its side effects.

This combination medicine also contains caffeine.

In the U.S., this combination medicine is available only with your doctor's prescription.

Before Using Orphengesic

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

Do not give a medicine containing aspirin to a child or a teenager with a fever or other symptoms of a virus infection, especially flu or chickenpox, without first discussing its use with your child's doctor. This is very important because aspirin may cause a serious illness called Reye's syndrome in children with fever caused by a virus infection, especially flu or chickenpox. Children who do not have a virus infection may also be more sensitive to the effects of aspirin, especially if they have a fever or have lost large amounts of body fluid because of vomiting, diarrhea, or sweating. This may increase the chance of side effects during treatment.

There is no specific information about the use of orphenadrine in children.

Geriatric

Elderly people are especially sensitive to the effects of aspirin. This may increase the chance of side effects during treatment.

There is no specific information about the use of orphenadrine in the elderly.

Pregnancy

	Pregnancy Category	Explanation
All Trimesters	D	Studies in pregnant women have demonstrated a risk to the fetus. However, the benefits of therapy in a life threatening situation or a serious disease, may outweigh the potential risk.

Breast Feeding

AspirinOrphenadrine

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.

Caffeine

Studies in women suggest that this medication poses minimal risk to the infant when used during breastfeeding.

Interactions with Medicines

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

Using this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.

• Influenza Virus Vaccine, Live


• Ketorolac

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.

• Acenocoumarol


• Alteplase, Recombinant


• Anisindione


• Beta Glucan


• Cilostazol


• Citalopram


• Clovoxamine


• Dabigatran Etexilate


• Desirudin


• Desvenlafaxine


• Dicumarol


• Duloxetine


• Eptifibatide


• Escitalopram


• Femoxetine


• Flesinoxan


• Fluoxetine


• Fluvoxamine


• Ginkgo


• Heparin


• Ketoprofen


• Methotrexate


• Milnacipran


• Naproxen


• Nefazodone


• Paroxetine


• Phenindione


• Phenprocoumon


• Reteplase, Recombinant


• Rivaroxaban


• Sertraline


• Ticlopidine


• Varicella Virus Vaccine


• Venlafaxine


• Vilazodone


• Warfarin


• Zimeldine

Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Anagrelide


• Ardeparin


• Azosemide


• Bemetizide


• Bendroflumethiazide


• Benzthiazide


• Betamethasone


• Bumetanide


• Buthiazide


• Captopril


• Celecoxib


• Certoparin


• Chlorothiazide


• Chlorpropamide


• Chlorthalidone


• Clopamide


• Cortisone


• Cyclopenthiazide


• Dalteparin


• Danaparoid


• Deflazacort


• Delapril


• Dexamethasone


• Diltiazem


• Enalaprilat


• Enalapril Maleate


• Enoxaparin


• Ethacrynic Acid


• Furosemide


• Glyburide


• Hydrochlorothiazide


• Hydroflumethiazide


• Ibuprofen


• Imidapril


• Indapamide


• Lisinopril


• Methyclothiazide


• Methylprednisolone


• Metolazone


• Nadroparin


• Nitroglycerin


• Paramethasone


• Parnaparin


• Perphenazine


• Piretanide


• Polythiazide


• Prednisolone


• Prednisone


• Probenecid


• Reviparin


• Rofecoxib


• Streptokinase


• Tamarind


• Temocapril


• Tenecteplase


• Tinzaparin


• Tirofiban


• Tolbutamide


• Torsemide


• Triamcinolone


• Trichlormethiazide


• Valproic Acid


• Verapamil


• Xipamide

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. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following may cause an increased risk of certain side effects but may be unavoidable in some cases. If used together, your doctor may change the dose or how often you use this medicine, or give you special instructions about the use of food, alcohol, or tobacco.

• Ethanol

Other Medical Problems

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

• Anemia or


• Overactive thyroid or


• Stomach ulcer or other stomach problems—Aspirin may make your condition worse

• Asthma, allergies, and nasal polyps, history of or


• Glucose-6-phosphate dehydrogenase (G6PD) deficiency or


• Kidney disease or


• Liver disease—The chance of side effects may be increased

• Disease of the digestive tract, especially esophagus disease or intestinal blockage, or


• Enlarged prostate or


• Fast or irregular heartbeat or


• Glaucoma or


• Myasthenia gravis or


• Urinary tract blockage—Orphenadrine has side effects that may be harmful to people with these conditions

• Gout—Aspirin can make this condition worse and can also lessen the effects of some medicines used to treat gout

• Heart disease—The chance of some side effects may be increased. Also, the caffeine present in this combination medicine can make your condition worse

• Hemophilia or other bleeding problems or


• Vitamin K deficiency—Aspirin may increase the chance of bleeding

Proper Use of orphenadrine, aspirin, and caffeine

This section provides information on the proper use of a number of products that contain orphenadrine, aspirin, and caffeine. It may not be specific to Orphengesic. Please read with care.

Take this medicine with food or a full glass (8 ounces) of water to lessen stomach irritation.

Do not take this medicine if it has a strong vinegar-like odor. This odor means the aspirin in it is breaking down. If you have any questions about this, check with your health care professional.

Do not take more of this medicine than your doctor ordered to lessen the chance of side effects or overdose.

Dosing

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

• For oral dosage forms (tablets):
  
  • For muscle pain and stiffness:
    
    • Adults and teenagers—One or two tablets containing 25 milligrams (mg) of orphenadrine and 385 mg of aspirin, or one-half or one tablet containing 50 mg of orphenadrine and 770 mg of aspirin, three or four times a day.
    
    
    • Children—Dose must be determined by your doctor.
    
    
  
  

Missed Dose

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

Storage

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

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Precautions While Using Orphengesic

If you will be taking this medicine for a long time (for example, more than a few weeks), your doctor should check your progress at regular visits.

Check the labels of all nonprescription (over-the-counter [OTC]) and prescription medicines you now take. If any contain orphenadrine or aspirin or other salicylates be especially careful, since taking them while taking this medicine may lead to overdose. If you have any questions about this, check with your health care professional.

Too much use of acetaminophen or certain other medicines together with the aspirin in this combination medicine may increase the chance of unwanted effects. The risk depends on how much of each medicine you take every day, and on how long you take the medicines together. If your doctor directs you to take these medicines together on a regular basis, follow his or her directions carefully. However, do not take acetaminophen or any of the following medicines together with this combination medicine for more than a few days, unless your doctor has directed you to do so and is following your progress:

• Diclofenac (e.g., Voltaren)


• Diflunisal (e.g., Dolobid)


• Etodolac (e.g., Lodine)


• Fenoprofen (e.g., Nalfon)


• Floctafenine (e.g., Idarac)


• Flurbiprofen, oral (e.g., Ansaid)


• Ibuprofen (e.g., Motrin)


• Indomethacin (e.g., Indocin)


• Ketoprofen (e.g., Orudis)


• Ketorolac (e.g., Toradol)


• Meclofenamate (e.g., Meclomen)


• Mefenamic acid (e.g., Ponstel)


• Nabumetone (e.g., Relafen)


• Naproxen (e.g., Naprosyn)


• Oxaprozin (e.g., Daypro)


• Phenylbutazone (e.g., Butazolidin)


• Piroxicam (e.g., Feldene)


• Sulindac (e.g., Clinoril)


• Tenoxicam (e.g., Mobiflex)


• Tiaprofenic acid (e.g., Surgam)


• Tolmetin (e.g., Tolectin)

For diabetic patients:

• The aspirin in this combination medicine may cause false urine sugar test results if you are regularly taking 6 or more of the regular-strength tablets or 3 or more of the double-strength tablets of this medicine a day. Smaller doses or occasional use of aspirin usually will not affect urine sugar tests. If you have any questions about this, check with your health care professional especially if your diabetes is not well controlled.

Do not take this medicine for 5 days before any surgery, including dental surgery, unless otherwise directed by your medical doctor or dentist. Taking aspirin during this time may cause bleeding problems.

The orphenadrine in this combination medicine may add to the effects of alcohol and other CNS depressants (medicines that slow down the nervous system, possibly causing drowsiness). Some examples of CNS depressants are antihistamines or medicine for hay fever, other allergies, or colds; sedatives, tranquilizers, or sleeping medicine; prescription pain medicine or narcotics; barbiturates; medicine for seizures; other muscle relaxants; or anesthetics, including some dental anesthetics. Also, stomach problems may be more likely to occur if you drink alcoholic beverages while you are taking aspirin. Do not drink alcoholic beverages, and check with your doctor before taking any of the medicines listed above, while you are using this medicine.

This medicine may cause some people to have blurred vision or to become drowsy, dizzy, lightheaded, faint, or less alert than they are normally. Make sure you know how you react to this medicine before you drive, use machines, or do anything else that could be dangerous if you are dizzy or are not alert.

Dryness of the mouth may occur while you are taking this medicine. For temporary relief, use sugarless candy or gum, melt bits of ice in your mouth, or use a saliva substitute. However, if dry mouth continues for more than 2 weeks, check with your dentist. Continuing dryness of the mouth may increase the chance of dental disease, including tooth decay, gum disease, and fungus infections.

If you think that you or someone else may have taken an overdose of this medicine, get emergency help at once. Taking an overdose of this medicine may cause unconsciousness or death. Signs of overdose include convulsions (seizures), hearing loss, confusion, ringing or buzzing in the ears, severe drowsiness or tiredness, severe excitement or nervousness, and fast or deep breathing.

Orphengesic 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.

Get emergency help immediately if any of the following symptoms of overdose occur:

Symptoms of overdose in children

• Changes in behavior


• drowsiness or tiredness (severe)


• fast or deep breathing

• Any loss of hearing


• bloody urine


• confusion


• convulsions (seizures)


• diarrhea


• dizziness or lightheadedness (severe)


• drowsiness (severe)


• excitement or nervousness (severe)


• fast or deep breathing


• hallucinations (seeing, hearing, or feeling things that are not there)


• headache (severe or continuing)


• increased sweating


• nausea or vomiting (severe or continuing)


• ringing or buzzing in the ears (continuing)


• uncontrollable flapping movements of the hands, especially in elderly patients


• unexplained fever


• unusual thirst


• vision problems

Check with your doctor as soon as possible if any of the following side effects occur:

Less common or rare

• Abdominal or stomach pain, cramping, or burning (severe)


• bloody or black, tarry stools


• decreased urination


• eye pain


• fainting


• fast or pounding heartbeat


• shortness of breath, troubled breathing, tightness in chest, or wheezing


• skin rash, hives, itching, or redness


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


• swollen and/or painful glands


• unusual bleeding or bruising


• unusual tiredness or weakness


• vomiting of blood or material that looks like coffee grounds

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

• Abdominal or stomach cramps, pain, or discomfort (mild to moderate)


• dryness of mouth


• heartburn or indigestion


• nausea or vomiting (mild)

Less common

• Blurred or double vision or other vision problems


• confusion


• constipation


• difficult urination


• dizziness or lightheadedness


• drowsiness


• excitement, nervousness, or restlessness


• headache


• muscle weakness


• trembling


• unusually large pupils of eyes

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

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

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

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

More Orphengesic resources

• Orphengesic Use in Pregnancy & Breastfeeding
• Orphengesic Drug Interactions
• Orphengesic Support Group
• 0 Reviews for Orphengesic - Add your own review/rating

• Norgesic Prescribing Information (FDA)


• Norgesic Concise Consumer Information (Cerner Multum)

Compare Orphengesic with other medications

• Muscle Pain
• Muscle Spasm

OB Complete 400

Pronunciation: pree-NATE-al muhl-tee-VYE-ta-min/VYE-ta-min A/MIN-er-als/EYE-urn/FOE-lik AS-id
Generic Name: Prenatal Multivitamin without Vitamin A with Minerals, Iron, Folic Acid, DHA
Brand Name: Examples include OB Complete 400 and PreferaOB One

Accidental overdose of products that contain iron is a leading cause of fatal poisoning in children younger than 6 years old. Keep this and all medicines out of the reach of children. In case of accidental ingestion, call the poison control center or doctor at once.

OB Complete 400 is used for:

Treating or preventing a lack of vitamins or minerals before, during, and after pregnancy and while breast-feeding. It may also be used for other conditions as determined by your doctor.

OB Complete 400 is a vitamin, mineral, iron, folic acid, and docosahexaenoic acid (DHA) combination. It works by providing vitamins and minerals to the body to help meet nutritional requirements.

Do NOT use OB Complete 400 if:

• you are allergic to any ingredient in OB Complete 400


• you have hemochromatosis (a disorder of iron metabolism)

Contact your doctor or health care provider right away if this applies to you.

Before using OB Complete 400:

Some medical conditions may interact with OB Complete 400. 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 (including soybeans, fish, or fish oil)


• if you have stomach or intestinal problems (eg, colitis, Crohn disease, diverticulitis), pernicious anemia or other blood problems (eg, anemia, porphyria), bleeding problems (eg, hemophilia), peptic ulcer, or kidney stones


• if you have had multiple blood transfusions

Some MEDICINES MAY INTERACT with OB Complete 400. Tell your health care provider if you are taking any other medicines, especially any of the following:

• Oral anticoagulants (eg, warfarin) because the risk of bleeding may be increased by OB Complete 400


• Aliskiren, angiotensin-converting enzyme (ACE) inhibitors (eg, captopril), eplerenone, or potassium-sparing diuretics (eg, triamterene) because high blood potassium levels may occur


• Fluorouracil because the risk of its side effects may be increased by OB Complete 400


• Doxycycline, hydantoins (eg, phenytoin), levodopa, methyldopa, mycophenolate, penicillamine, or thyroid hormones (eg, levothyroxine) because their effectiveness may be decreased by OB Complete 400

This may not be a complete list of all interactions that may occur. Ask your health care provider if OB Complete 400 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 OB Complete 400:

Use OB Complete 400 as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• Check with your doctor or pharmacist to see if you should take OB Complete 400 with food or on an empty stomach. If stomach upset occurs, take with food to reduce stomach irritation.


• Take OB Complete 400 by mouth with a full glass of water (8 oz/240 mL).


• Do not take an antacid within 1 hour before or 2 hours after you take OB Complete 400.


• Avoid taking OB Complete 400 with dairy products; they may interfere with the absorption of the iron in OB Complete 400.


• Many medicines (eg, used for infection, blood pressure, immune system suppression, low blood platelet levels, osteoporosis, thyroid problems) should not be taken at the same time as OB Complete 400; their effectiveness may be decreased. Ask your doctor or pharmacist if your dose of OB Complete 400 should be separated from your dose of any of your other medicines.


• If you miss a dose of OB Complete 400, 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 OB Complete 400.

Important safety information:

• Do NOT take more than the recommended dose without checking with your doctor.


• Do not take large doses of vitamins while you use OB Complete 400 unless your doctor tells you to.


• Tell your doctor or dentist that you take OB Complete 400 before you receive any medical or dental care, emergency care, or surgery.


• OB Complete 400 may discolor the stools. This is normal and not a cause for concern.


• OB Complete 400 has iron in it. Iron overdose is a leading cause of fatal poisoning in children younger than 6 years old. In case of an overdose, call a doctor or poison control center right away.


• OB Complete 400 has pyridoxine (vitamin B₆) and folic acid in it. Before you start any medicine, check the label to see if it has pyridoxine or folic acid in it too. If it does or if you are not sure, check with your doctor or pharmacist.


• Some brands of OB Complete 400 may contain fish oil or soy. If you have had an allergic reaction to fish, fish oil, or soy ask your pharmacist if your brand contains fish oil or soy.


• PREGNANCY and BREAST-FEEDING: OB Complete 400 is intended for use during pregnancy and breast-feeding. If you are or will be breast-feeding while you use OB Complete 400, check with your doctor.

Possible side effects of OB Complete 400:

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:

Constipation; dark or discolored stools; diarrhea; nausea; stomach upset; vomiting.

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

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); black, tarry stools; blood or streaks of blood in the stools; stomach pain or cramping.

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: OB Complete 400 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 black, tarry stools; chest pain; lack of feeling alert; loss of balance; seizure; severe nausea, vomiting, diarrhea, or stomach pain; shortness of breath; sluggishness; trouble breathing; unusual tiredness or weakness; unusually pale skin; weak pulse.

Proper storage of OB Complete 400:

Store OB Complete 400 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 OB Complete 400 out of the reach of children and away from pets.

General information:

• If you have any questions about OB Complete 400, please talk with your doctor, pharmacist, or other health care provider.


• OB Complete 400 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 summary only. It does not contain all information about OB Complete 400. 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 OB Complete 400 resources

• OB Complete 400 Side Effects (in more detail)
• OB Complete 400 Use in Pregnancy & Breastfeeding
• OB Complete 400 Drug Interactions
• 0 Reviews for OB Complete 400 - Add your own review/rating

• Advance Care Plus Concise Consumer Information (Cerner Multum)


• CitraNatal Assure Prescribing Information (FDA)


• CitraNatal Harmony Prescribing Information (FDA)


• Concept DHA Prescribing Information (FDA)


• Docosavit Prescribing Information (FDA)


• Folcal DHA Prescribing Information (FDA)


• Folcaps Care One Prescribing Information (FDA)


• Gesticare DHA Prescribing Information (FDA)


• Inatal Advance Prescribing Information (FDA)


• Inatal Ultra Prescribing Information (FDA)


• Multi-Nate DHA Prescribing Information (FDA)


• Multi-Nate DHA Extra Prescribing Information (FDA)


• Multifol Plus Concise Consumer Information (Cerner Multum)


• Natelle One Prescribing Information (FDA)


• Paire OB Plus DHA Prescribing Information (FDA)


• PreNexa Prescribing Information (FDA)


• PreferaOB Prescribing Information (FDA)


• Prenatal Plus Prescribing Information (FDA)


• Prenatal Plus Iron Prescribing Information (FDA)


• Prenate Elite tablets


• Prenate Elite Prescribing Information (FDA)


• Prenate Essential Prescribing Information (FDA)


• PrimaCare ONE capsules


• Renate DHA Prescribing Information (FDA)


• Se-Natal 19 Prescribing Information (FDA)


• Tandem DHA Prescribing Information (FDA)


• Tandem OB Prescribing Information (FDA)


• TriAdvance Prescribing Information (FDA)


• Triveen-PRx RNF Prescribing Information (FDA)


• UltimateCare ONE NF Prescribing Information (FDA)


• Vinate AZ Prescribing Information (FDA)


• Zatean-CH Prescribing Information (FDA)

Compare OB Complete 400 with other medications

• Vitamin/Mineral Supplementation during Pregnancy/Lactation

Oticin Ear Drops

chloroxylenol and pramoxine hydrochloride

Dosage Form: ear drops
Oticin Ear Drops

DESCRIPTION

Each 10 mL for otic administration contains:

Parachlorometaxylenol …..….. 0.010 gm

Proxazocain HCl …………..…. 0.100 gm

Parachlorometaxylenol (4-chloro-3,5-xylenol) is a wide spectrum antimicrobial agent.

Proxazocain (p-butoxyphenyl γ-morpholinopropyl ether), used as the hydrochloride salt, is a topical anesthetic.

INACTIVE INGREDIENT

Oticin Ear Drops also contains propylene glycol USP as an inactive ingredient.

CLINICAL PHARMACOLOGY

Parachlorometaxylenol in low concentrations is a germicide that may be used to treat bacterial and fungal infections. It is a halogenated phenol, non-toxic, non-corrosive, non-staining with a high phenol coefficient. It may be applied directly to a wound and shows no chemical reactivity toward blood.

Proxazocain HCl is a topical anesthetic which is chemically unrelated to procaine and the other "caines". It provides temporary relief from itching and pain by stabilizing the neuronal membranes of nerve endings with which it comes into contact.

INDICATIONS AND USAGE

For the treatment of superficial infections of the external ear caused by microbes and to control the accompanying itching.

CONTRAINDICATIONS

This medication is contraindicated in patients sensitive to any of the components of this preparation. This medication should not be applied in the external auditory canal where there is a perforated eardrum or when this medication can reach the middle ear.

WARNINGS

This product is not intended for ophthalmic or oral use. If irritation or sensitization occurs, promptly discontinue use of this preparation and institute other measures.

PRECAUTIONS

General

Treatment should not be continued for longer than ten days and the source of infection and/or inflammation or sensitization evaluated to determine whether therapy should be changed.

Information for Patients: Patients using this medication should be advised of the following:

• This medication is to be used as directed by a physician.

• Do not use this medication for any disorder other than for which it was prescribed. Check with your physician before using this medication for future ear problems.

• Report any signs of local adverse reactions to your physician.

• Keep this and all medications out of the reach of children. In case of accidental overdose or ingestion, seek professional assistance or contact a poison control center immediately.

• Store at controlled room temperature between 15(- 30(C (59(- 86(F).

Carcinogenesis, Mutagenesis, Impairment of Fertility

No long-term studies have been performed to evaluate the carcinogenic or mutagenic potential of this product.

Pregnancy

Pregnancy category C: There are no adequate and well-controlled studies in pregnant women. Oticin Ear Drops should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

DOSAGE AND ADMINISTRATION

The external ear that is the auricle and the auditory canal should be thoroughly cleansed and dried. Four (4) to five (5) drops of Oticin Ear Drops should be instilled into the affected ear 3 to 4 times daily. For infants and small children, 3 drops are suggested because of the smaller capacity of the ear canal. The patient should lie with the affected ear upward to instill the drops and this position maintained for at least 5 minutes to facilitate penetration of the drops into the ear canal. Repeat, if necessary for the opposite affected ear. If preferred, a gauze ear plug or wick may be inserted into the ear canal prior to applying Oticin Ear Drops. When using a wick, a few drops of sterile water should be applied directly to the wick following insertion to facilitate hydration. It should then be saturated with Oticin Ear Drops. The patient should be instructed to add a few drops of Oticin Ear Drops to the wick every four hours, and to remove the wick after 24 hours. Five (5) drops of Oticin Ear Drops should continue to be instilled 3 or 4 times daily thereafter. When using a gauze earplug, the external ear canal is first treated with drops of Oticin Ear Drops. Next, the gauze is inserted into the ear canal to contain medication. The gauze ear plug or the expanded wick are easily removed by fingers, forceps, or tweezers. This product may continue to be used in the unaffected ear 3 times daily as a preventative.

HOW SUPPLIED

Oticin Ear Drops are supplied as a clear liquid in plastic dropper vials of 10 mL, NDC 68436-115-10.

KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN. IN CASE OF ACCIDENTAL OVERDOSE, SEEK PROFESSIONAL ASSISTANCE OR CONTACT A POISON CONTROL CENTER IMMEDIATELY.

Storage and Handling

Storage: Store at 15(- 30(C (59(- 86(F).

Pharmacist: Protect from light. Dispense in this container.

Rx Only

Manufactured for:

Teral, Inc.

Ponce, P.R. 00716

500388    Iss. 05/09

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Figure 1: Oticin Container Label

OTICIN  chloroxylenol / pramoxine hcl  solution/ drops

Product Information Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 68436-115 Route of Administration AURICULAR (OTIC) DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength CHLOROXYLENOL (CHLOROXYLENOL) CHLOROXYLENOL 0.010 g  in 10 mL PRAMOXINE HYDROCHLORIDE (PRAMOXINE) PRAMOXINE HYDROCHLORIDE 0.1 g  in 10 mL

Inactive Ingredients Ingredient Name Strength PROPYLENE GLYCOL

Product Characteristics Color      Score      Shape Size Flavor Imprint Code Contains

Packaging # NDC Package Description Multilevel Packaging 1 68436-115-10 1 BOTTLE In 1 PACKAGE contains a BOTTLE, DROPPER 1 10 mL In 1 BOTTLE, DROPPER This package is contained within the PACKAGE (68436-115-10)

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Unapproved drug other		11/12/2009

Labeler - Teral, Inc. (186958810)

Registrant - Teral, Inc. (186958810)

Establishment
Name	Address	ID/FEI	Operations
Sovereign Pharmaceuticals, LLC		623168267	MANUFACTURE

Revised: 11/2009Teral, Inc.

More Oticin Ear Drops resources

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

Compare Oticin Ear Drops with other medications

• Otitis Externa

Osmitrol

mannitol

Dosage Form: injection, solution
Osmitrol Injection (Mannitol Injection, USP)

in VIAFLEX Plastic Container

For Therapeutic Use Only

Osmitrol Description

Osmitrol Injection (Mannitol Injection, USP) is a sterile, nonpyrogenic solution of Mannitol, USP in a single dose container for intravenous administration. It contains no antimicrobial agents. Mannitol** is a six carbon sugar alcohol prepared commercially by the reduction of dextrose. Although virtually inert metabolically in humans, it occurs naturally in fruits and vegetables. Mannitol is an obligatory osmotic diuretic. The pH is adjusted with sodium hydroxide or hydrochloric acid. Composition, osmolarity, and pH are shown in Table 1

* Normal physiologic osmolarity range is approximately 280 to 310 mOsmol/L. Administration of substantially hypertonic solutions (≥600 mOsmol/L) may cause vein damage.
Table 1.
		Composition
	Size (mL)	**Mannitol, USP (g/L)	*Osmolarity (mOsmol/L) (calc)	pH
5% Osmitrol Injection (5% Mannitol Injection, USP)	1000	50	274	5.0 (4.5 TO 7.0)
10% Osmitrol Injection (10% Mannitol Injection, USP)	500	100	549	5.0 (4.5 TO 7.0)
	1000
15% Osmitrol Injection (15% Mannitol Injection, USP)	500	150	823	5.0 (4.5 TO 7.0)
20% Osmitrol Injection (20% Mannitol Injection, USP)	250	200	1098	5.0 (4.5 TO 7.0)
	500

The VIAFLEX plastic container is fabricated from a specially formulated polyvinyl chloride (PL 146 Plastic). The amount of water that can permeate from inside the container into the overwrap is insufficient to affect the solution significantly. Solutions in contact with the plastic container can leach out certain of its chemical components in very small amounts within the expiration period, e.g., di-2-ethylhexyl phthalate (DEHP), up to 5 parts per million. However, the safety of the plastic has been confirmed in tests in animals according to USP biological tests for plastic containers as well as by tissue culture toxicity studies.

Osmitrol - Clinical Pharmacology

Osmitrol Injection (Mannitol Injection, USP) is one of the nonelectrolyte, obligatory, osmotic diuretics. It is freely filterable at the renal glomerulus, only poorly reabsorbed by the renal tubule, not secreted by the tubule, and is pharmacologically inert.

Mannitol, when administered intravenously, exerts its osmotic effect as a solute of relatively small molecular size being largely confined to the extracellular space. Only relatively small amounts of the dose administered is metabolized. Mannitol is readily diffused through the glomerulus of the kidney over a wide range of normal and impaired kidney function. In this fashion, approximately 80% of a 100 gram dose of mannitol will appear in the urine in three hours with lesser amounts thereafter. Even at peak concentrations, mannitol will exhibit less than 10% of tubular reabsorption and is not secreted by tubular cells. Mannitol will hinder tubular reabsorption of water and enhance excretion of sodium and chloride by elevating the osmolarity of the glomerular filtrate.

This increase in extracellular osmolarity effected by the intravenous administration of mannitol will induce the movement of intracellular water to the extracellular and vascular spaces. This action underlies the role of mannitol in reducing intracranial pressure, intracranial edema, and elevated intraocular pressure.

Indications and Usage for Osmitrol

Osmitrol Injection (Mannitol Injection, USP) is indicated for:

The promotion of diuresis, in the prevention and/or treatment of the oliguric phase of acute renal failure before irreversible renal failure becomes established;

The reduction of intracranial pressure and treatment of cerebral edema by reducing brain mass;

The reduction of elevated intraocular pressure when the pressure cannot be lowered by other means, and

Promoting the urinary excretion of toxic substances.

Contraindications

Osmitrol Injection (Mannitol Injection, USP) is contraindicated in patients with:

Well established anuria due to severe renal disease,

Severe pulmonary congestion or frank pulmonary edema,

Active intracranial bleeding except during craniotomy,

Severe dehydration,

Progressive renal damage or dysfunction after institution of mannitol therapy, including increasing oliguria and azotemia, and

Progressive heart failure or pulmonary congestion after institution of mannitol therapy.

Warnings

In patients with severe impairment of renal function, a test dose should be utilized (see Dosage and Administration). A second test dose may be tried if there is an inadequate response, but no more than two test doses should be attempted.

The obligatory diuretic response following rapid infusion of 15% or 20% mannitol injection may further aggravate preexisting hemoconcentration. Excessive loss of water and electrolytes may lead to serious imbalances. Serum sodium and potassium should be carefully monitored during mannitol administration.

If urine output continues to decline during mannitol infusion, the patient’s clinical status should be closely reviewed and mannitol infusion suspended if necessary. Accumulation of mannitol may result in overexpansion of the extracellular fluid which may intensify existing or latent congestive heart failure.

fxcessive loss of water and electrolytes may lead to serious imbalances. With continued administration of mannitol, loss of water in excess of electrolytes can cause hypernatremia. Electrolyte measurements, including sodium and potassium, are therefore, of vital importance in monitoring the infusion of mannitol.

Osmotic nephrosis, a reversible vacuolization of the tubules of unknown clinical significance, may proceed to severe irreversible nephrosis, so that the renal function must be closely monitored during mannitol infusion.

Precautions

The cardiovascular status of the patient should be carefully evaluated before rapidly administering mannitol since sudden expansion of the extracellular fluid may lead to fulminating congestive heart failure.

Shift of sodium free intracellular fluid into the extracellular compartment following mannitol infusion may lower serum sodium concentration and aggravate preexisting hyponatremia.

By sustaining diuresis, mannitol administration may obscure and intensify inadequate hydration or hypovolemia.

Electrolyte free mannitol injections should not be given conjointly with blood. If it is essential that blood be given simultaneously, at least 20 mEq of sodium chloride should be added to each liter of mannitol solution to avoid pseudoagglutination.

When exposed to low temperatures, solutions of mannitol may crystallize. Concentrations greater than 15% have a greater tendency to crystallization. Inspect for crystals prior to administration. If crystals are visible, redissolve by warming the solution up to 70°C, with agitation. Allow the solution to cool to room temperature before reinspection for crystals. Administer intravenously using sterile, filter-type administration set.

Laboratory Tests

Although blood levels of mannitol can be measured, there is little if any clinical virtue in doing so. The appropriate monitoring of blood levels of sodium and potassium; degree of hemoconcentration or hemodilution, if any; indices of renal, cardiac and pulmonary function are paramount in avoiding excessive fluid and electrolyte shifts. The routine features of physical examination and clinical chemistries suffice in achieving an adequate degree of appropriate patient monitoring.

Pregnancy: Teratogenic Effects

Pregnancy Category C

Animal reproduction studies have not been conducted with mannitol. It is also not known whether mannitol can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Mannitol should be given 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 mannitol is administered to a nursing woman.

Pediatric Use

Safety and effectiveness in children below the age of 12 have not been established.

Usage in Children

Dosage requirements for patients 12 years of age and under have not been established.

Geriatric Use

Clinical studies of Osmitrol Injection (Mannitol Injection, USP) did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Other reported clinical experience has not identified differences in responses between the elderly and younger patients. In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy.

This drug is known to be substantially excreted by the kidney, and the risk of toxic reactions to this drug may be greater in patients with impaired renal function. Because elderly patients are more likely to have decreased renal function, care should be taken in dose selection, and it may be useful to monitor renal function.

Adverse Reactions

Extensive use of mannitol over the last several decades has produced recorded adverse events, in a variety of clinical settings, that are isolated or idiosyncratic in nature. None of these adverse reactions have occurred with any great frequency nor with any security in attributing them to mannitol.

The inability to clearly exclude the drug related nature of such events in these isolated reports prompts the necessity to list the reactions that have been observed in patients during or following mannitol infusion. In this fashion, patients have exhibited nausea, vomiting, rhinitis, local pain, skin necrosis and thrombophlebitis at the site of injection, chills, dizziness, urticaria, hypotension, hypertension, tachycardia, fever and angina-like chest pains.

Of far greater clinical significance is a variety of events that are related to inappropriate recognition and monitoring of fluid shifts. These are not intrinsic adverse reactions to the drug but the consequence of manipulating osmolarity by any agency in a therapeutically inappropriate manner. Failure to recognize severe impairment of renal function with the high likelihood of nondiuretic response can lead to aggravated dehydration of tissues and increased vascular fluid load. Induced diuresis in the presence of preexisting hemoconcentration and preexisting deficiency of water and electrolytes can lead to serious imbalances. Expansion of the extracellular space can aggravate cardiac decompensation or induce it in the presence of latent heart failure. Pulmonary congestion or edema can be seriously aggravated with the expansion of the extracellular and therefore intravascular fluid load. Hemodilution and dilution of the extracellular fluid space by osmotic shift of water can induce or aggravate preexisting hyponatremia.

If unrecognized, such fluid and/or electrolyte shift can produce the reported adverse reactions of pulmonary congestion, acidosis, electrolyte loss, dryness of mouth, thirst, edema, headache, blurred vision, convulsions and congestive cardiac failure.

These are not truly adverse reactions to the drug and can be appropriately prevented by evaluation of degree of renal failure with a test dose response to mannitol when indicated; evaluation of hypervolemia and hypovolemia; sodium and potassium levels; hemodilution or hemoconcentration; and evaluation of renal, cardiac and pulmonary function at the onset of therapy.

Osmitrol Dosage and Administration

Osmitrol Injection (Mannitol Injection, USP) should be administered only by intravenous infusion. The total dosage, concentration, and rate of administration should be governed by the nature and severity of the condition being treated, fluid requirement, and urinary output. The usual adult dosage ranges from 20 to 100 g in a 24 hour period, but in most instances an adequate response will be achieved at a dosage of approximately 50 to 100 g in a 24 hour period. The rate of administration is usually adjusted to maintain a urine flow of at least 30 to 50 mL/hour. This outline of administration and dosage is only a general guide to therapy.

Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration whenever solution and container permit. Use of a final filter is recommended during administration of all parenteral solutions, where possible.

Test Dose: A test dose of mannitol should be given prior to instituting Osmitrol Injection (Mannitol Injection, USP) therapy for patients with marked oliguria, or those believed to have inadequate renal function. Such a test dose may be approximately 0.2 g/kg body weight (about 75 mL of a 20% solution or 100 mL of a 15% solution) infused in a period of three to five minutes to produce a urine flow of at least 30 to 50 mL/hour. If urine flow does not increase, a second test dose may be given; if there is an inadequate response, the patient should be reevaluated.

Prevention of Acute Renal Failure (Oliguria): When used during cardiovascular and other types of surgery, 50 to 100 g of mannitol as a 5, 10, or 15% solution may be given. The concentration will depend upon the fluid requirements of the patient.

Treatment of Oliguria: The usual dose for treatment of oliguria is 100 g administered as a 15 or 20% solution.

Reduction of Intraocular Pressure: A dose of 1.5 to 2.0 g/kg as a 20% solution (7.5 to 10 mL/kg) or as a 15% solution (10 to 13 mL/kg) may be given over a period as short as 30 minutes in order to obtain a prompt and maximal effect. When used preoperatively the dose should be given one to one and one-half hours before surgery to achieve maximal reduction of intraocular pressure before operation.

Reduction of Intracranial Pressure: Usually a maximum reduction in intracranial pressure in adults can be achieved with a dose of 0.25 g/kg given not more frequently than every six to eight hours. An osmotic gradient between the blood and cerebrospinal fluid of approximately 10 mOsmol will yield a satisfactory reduction in intracranial pressure.

Adjunctive Therapy for Intoxications: As an agent to promote diuresis in intoxications, 5%, 10%, 15% or 20% mannitol is indicated. The concentration will depend upon the fluid requirement and urinary output of the patient.

Measurement of glomerular filtration rate by creatinine clearance may be useful for determination of dosage.

All injections in VIAFLEX containers are intended for intravenous administration using sterile equipment.

The use of supplemental additive medication is not recommended.

How is Osmitrol Supplied

Osmitrol Injection (Mannitol Injection, USP) in VIAFLEX plastic containers is available as follows:

Code	Size (mL)	NDC	Product Name
2D5604	1000	0338-0351-04	5% Osmitrol Injection (5% Mannitol Injection, USP)
2D5613	500	0338-0353-03	10% Osmitrol Injection (10% Mannitol Injection, USP)
2D5614	1000	0338-0353-04
2D5623	500	0338-0355-03	15% Osmitrol Injection (15% Mannitol Injection, USP)
2D5632	250	0338-0357-02	20% Osmitrol Injection (20% Mannitol Injection, USP)
2D5633	500	0338-0357-03

Exposure of pharmaceutical products to heat should be minimized. Avoid excessive heat. It is recommended the product be stored at room temperature (25°C); brief exposure up to 40°C does not adversely affect the product.

DIRECTIONS FOR USE OF VIAFLEX PLASTIC CONTAINER

Warning: Do not use plastic container in series connections. Such use could result in air embolism due to residual air being drawn from the primary container before administration of the fluid from the secondary container is completed.

To Open

Tear overwrap down side at slit and remove solution container. Some opacity of the plastic due to moisture absorption during the sterilization process may be observed. This is normal and does not affect the solution quality or safety. The opacity will diminish gradually. Check for minute leaks by squeezing inner bag firmly. If leaks are found, discard solution as sterility may be impaired.

Preparation for Administration

1. Suspend container from eyelet support.

2. Remove plastic protector from outlet port at bottom of container.

3. Attach administration set. Refer to complete directions accompanying set.

Baxter Healthcare Corporation

Deerfield, IL 60015 USA

Printed in USA

Baxter, Osmitrol, VIAFLEX, and PL 146 are trademarks of Baxter International Inc.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

5% Osmitrol Injection Container Label

2D5604

NDC 0338-0351-04

5% Osmitrol

Injection

(5% Mannitol

Injection USP)

1000 mL

EACH 100 mL CONTAINS 5 g MANNITOL USP pH ADJUSTED WITH

SODIUM HYDROXIDE OR HYDROCHLORIC ACID pH 5.0 (4.5 TO 7.0)

OSMOLARITY 274 mOsmol/L (CALC) STERILE NONPYROGENIC

SINGLE DOSE CONTAINER OSMOTIC DIURETIC DOSAGE INTRAVENOUSLY

AS DIRECTED BY A PHYSICIAN SEE DIRECTIONS CAUTIONS SQUEEZE AND

INSPECT INNER BAG WHICH MAINTAINS PRODUCT STERILITY DISCARD IF

LEAKS ARE FOUND DO NOT ADMINISTER SIMULTANEOUSLY WITH BLOOD

MUST NOT BE USED IN SERIES CONNECTIONS DO NOT USE UNLESS

SOLUTION IS CLEAR RX ONLY STORE UNIT IN MOISTURE BARRIER

OVERWRAP AT ROOM TEMPERATURE (25°C/77ºF) UNTIL READY TO USE

AVOID EXCESSIVE HEAT SEE INSERT

VIAFLEX CONTAINER

PL 146 PLASTIC

FOR PRODUCT INFORMATION

1-800-933-0303

BAXTER Osmitrol VIAFLEX

AND PL 146 ARE TRADEMARKS OF

BAXTER INTERNATIONAL INC 

BAXTER HEALTHCARE CORPORATION

DEERFIELD IL 60015 USA

MADE IN USA

5% Osmitrol Injection Carton Label

FOR HI-RES INK JET:

2D5604X 14-1000 ML

VIAFLEX CONTAINER

5% Osmitrol INJECTION

5% MANNITOL INJECTION, USP

EXP

XXXXX

SECONDARY BAR CODE

(01) 50303380351041

(17) YYMM00 (10) XXXXX

LOT

XXXXX

NOTE: YY=Year, MM=Month and Date will always be 00.

(Where applicable) Lot and Exp. Date added at the time of printing. Secondary bar code human readable is variable and will be added at time of printing. The parentheses are not encoded in actual bar code.

Osmitrol  mannitol  injection, solution

Product Information Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 0338-0351 Route of Administration INTRAVENOUS DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength MANNITOL (MANNITOL) MANNITOL 5 g  in 100 mL

Inactive Ingredients Ingredient Name Strength WATER   SODIUM HYDROXIDE   HYDROCHLORIC ACID

Product Characteristics Color      Score      Shape Size Flavor Imprint Code Contains

Packaging # NDC Package Description Multilevel Packaging 1 0338-0351-04 1000 mL In 1 BAG None

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
NDA	NDA013684	06/08/1964

Osmitrol  mannitol  injection, solution

Product Information Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 0338-0353 Route of Administration INTRAVENOUS DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength MANNITOL (MANNITOL) MANNITOL 10 g  in 100 mL

Inactive Ingredients Ingredient Name Strength WATER   SODIUM HYDROXIDE   HYDROCHLORIC ACID

Product Characteristics Color      Score      Shape Size Flavor Imprint Code Contains

Packaging # NDC Package Description Multilevel Packaging 1 0338-0353-03 500 mL In 1 BAG None 2 0338-0353-04 1000 mL In 1 BAG None

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
NDA	NDA013684	06/08/1964

Osmitrol  mannitol  injection, solution

Product Information Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 0338-0355 Route of Administration INTRAVENOUS DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength MANNITOL (MANNITOL) MANNITOL 15 g  in 100 mL

Inactive Ingredients Ingredient Name Strength WATER   SODIUM HYDROXIDE   HYDROCHLORIC ACID

Product Characteristics Color      Score      Shape Size Flavor Imprint Code Contains

Packaging # NDC Package Description Multilevel Packaging 1 0338-0355-03 500 mL In 1 BAG None

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
NDA	NDA013684	06/08/1964

Osmitrol  mannitol  injection, solution

Product Information Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 0338-0357 Route of Administration INTRAVENOUS DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength MANNITOL (MANNITOL) MANNITOL 20 g  in 100 mL

Inactive Ingredients Ingredient Name Strength WATER   SODIUM HYDROXIDE   HYDROCHLORIC ACID

Product Characteristics Color      Score      Shape Size Flavor Imprint Code Contains

Packaging # NDC Package Description Multilevel Packaging 1 0338-0357-02 250 mL In 1 BAG None 2 0338-0357-03 500 mL In 1 BAG None

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
NDA	NDA013684	06/08/1964

Labeler - Baxter Healthcare Corporation (005083209)

Establishment
Name	Address	ID/FEI	Operations
Baxter Healthcare Corporation		059140764	MANUFACTURE

Revised: 12/2009Baxter Healthcare Corporation

More Osmitrol resources

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

• Osmitrol Monograph (AHFS DI)


• Osmitrol MedFacts Consumer Leaflet (Wolters Kluwer)


• Aridol Consumer Overview


• Aridol Advanced Consumer (Micromedex) - Includes Dosage Information

Compare Osmitrol with other medications

• Cerebral Edema
• Oliguria

Osteo Bi-Flex Advanced

Generic Name: chondroitin, glucosamine, and methylsulfonylmethane (kon DROI tin, gloo KOSE a meen, and METH il sul FON il METH ane)

Brand Names: Glucosamine & Chondroitin with MSM, Glucosamine Chondroitin MSM Complex, Osteo Bi-Flex Advanced, Osteo Bi-Flex Plus MSM

What is Osteo Bi-Flex Advanced (chondroitin, glucosamine, and methylsulfonylmethane)?

Chondroitin is a naturally occurring substance formed of sugar chains. Chondroitin is believed to help the body maintain fluid and flexibility in the joints.

Glucosamine is a naturally occurring substance that is believed to help develop and renew cartilage (the hard connective tissue mainly located on bones near joints in the body), and keep it lubricated for better joint movement and flexibility.

Methylsulfonylmethane is a naturally occurring form of sulfur that helps support muscles and tendons in the body.

The combination of chondroitin, glucosamine, and methylsulfonylmethane is used to aid in maintaining healthy joints. It is also used as a nutritional supplement in people with osteoarthritis or other inflammatory joint disorders.

Not all uses for chondroitin, glucosamine, and methylsulfonylmethane have been approved by the FDA. Chondroitin, glucosamine, and methylsulfonylmethane should not be used in place of medication prescribed for you by your doctor.

Chondroitin, glucosamine, and methylsulfonylmethane is often sold as an herbal supplement. There are no regulated manufacturing standards in place for many herbal compounds and some marketed supplements have been found to be contaminated with toxic metals or other drugs. Herbal/health supplements should be purchased from a reliable source to minimize the risk of contamination.

Chondroitin, glucosamine, and methylsulfonylmethane may also be used for purposes not listed in this product guide.

What is the most important information I should know about Osteo Bi-Flex Advanced (chondroitin, glucosamine, and methylsulfonylmethane)?

Not all uses for this product have been approved by the FDA. Chondroitin, glucosamine, and methylsulfonylmethane should not be used in place of medication prescribed for you by your doctor.

Chondroitin, glucosamine, and methylsulfonylmethane is often sold as an herbal supplement. There are no regulated manufacturing standards in place for many herbal compounds and some marketed supplements have been found to be contaminated with toxic metals or other drugs. Herbal/health supplements should be purchased from a reliable source to minimize the risk of contamination.

Before using this product, talk to your doctor, pharmacist, herbalist, or other healthcare provider. You may not be able to use chondroitin, glucosamine, and methylsulfonylmethane if you have diabetes, a bleeding or blood clotting disorder such as hemophilia, if you have allergies to certain drugs, if you are overweight, or if you are on a low-salt diet.

Do not take chondroitin, glucosamine, and methylsulfonylmethane without the medical advice if you are using insulin, or a blood thinner such as warfarin (Coumadin, Jantoven). Avoid taking chitosan (usually marketed as a weight-loss product) while you are taking chondroitin, glucosamine, and methylsulfonylmethane. Chitosan can make it harder for your body to absorb chondroitin.

What should I discuss with my healthcare provider before taking Osteo Bi-Flex Advanced (chondroitin, glucosamine, and methylsulfonylmethane)?

You should not use this product if you are allergic to it.

Ask a doctor, pharmacist, herbalist, or other healthcare provider if it is safe for you to use this product if you have:

• 
  

  diabetes;

  
  


• 
  

  a bleeding or blood clotting disorder such as hemophilia;

  
  


• 
  

  if you have allergies to certain drugs;

  
  


• 
  

  if you are overweight; or

  
  


• 
  

  if you are on a low-salt diet.

  
  

It is not known whether chondroitin, glucosamine, and methylsulfonylmethane will harm an unborn baby. Tell your healthcare provider if you are pregnant or plan to become pregnant while using this product. It is not known whether chondroitin, glucosamine, and methylsulfonylmethane passes into breast milk or if it could harm a nursing baby. Do not use this product without telling your healthcare provider if you are breast-feeding a baby.

How should I take Osteo Bi-Flex Advanced (chondroitin, glucosamine, and methylsulfonylmethane)?

When considering the use of herbal supplements, seek the advice of your doctor. You may also consider consulting a practitioner who is trained in the use of herbal/health supplements.

If you choose to use chondroitin, glucosamine, and methylsulfonylmethane, use it as directed on the package or as directed by your doctor, pharmacist, or other healthcare provider. Do not use more of this product than is recommended on the label.

It may take up several weeks before your symptoms improve. Keep using the medication as directed and tell your doctor if your symptoms do not improve after a few weeks of treatment.

Glucosamine may increase the glucose (sugar) levels in your blood. If you have diabetes, you may need to check your blood sugar more often while taking this medication. You may also need to adjust your insulin dosage. Do not change your dose or medication schedule without advice from your doctor.

Chondroitin, glucosamine, and methylsulfonylmethane may be only part of a complete program of treatment that also includes diet, exercise, and weight control. Follow your diet, medication, and exercise routines very closely.

Store at room temperature away from moisture, heat, and light.

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.

What should I avoid while taking Osteo Bi-Flex Advanced (chondroitin, glucosamine, and methylsulfonylmethane)?

Avoid taking chitosan (usually marketed as a weight-loss product) while you are taking chondroitin, glucosamine, and methylsulfonylmethane. Chitosan can make it harder for your body to absorb chondroitin.

Osteo Bi-Flex Advanced (chondroitin, glucosamine, and methylsulfonylmethane) 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.

Less serious side effects may include:

• 
  

  mild nausea, upset stomach;

  
  


• 
  

  heartburn; or

  
  


• 
  

  diarrhea.

  
  

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

What other drugs will affect Osteo Bi-Flex Advanced (chondroitin, glucosamine, and methylsulfonylmethane)?

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

• 
  

  insulin; or

  
  


• 
  

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

  
  

This list is not complete and other drugs may interact with chondroitin, glucosamine, and methylsulfonylmethane. Tell your healthcare provider 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 Osteo Bi-Flex Advanced resources

• Osteo Bi-Flex Advanced Drug Interactions
• Osteo Bi-Flex Advanced Support Group
• 0 Reviews for Osteo Bi-Flex Advanced - Add your own review/rating

Compare Osteo Bi-Flex Advanced with other medications

• Dietary Supplementation
• Osteoarthritis

Where can I get more information?

• Consult with a licensed healthcare professional before using any herbal/health supplement. Whether you are treated by a medical doctor or a practitioner trained in the use of natural medicines/supplements, make sure all your healthcare providers know about all of your medical conditions and treatments.