Febcid may be available in the countries listed below.
Ingredient matches for Febcid
Famotidine
Famotidine is reported as an ingredient of Febcid in the following countries:
- Sri Lanka
International Drug Name Search
Friday, September 30, 2016
Tilade
Generic Name: Nedocromil Sodium
Class: Mast-cell Stabilizers
ATC Class: R01AC07
VA Class: RE101
Chemical Name: 9-Ethyl-6,9-dihydro-4,6-dioxo-10-propyl-4H-pyrano(3,2-g)quinoline-2,8-dicarboxylic acid disodium salt
Molecular Formula: C19H17NO7•2Na
CAS Number: 69049-74-7
Introduction
Mast cell stabilizer; a pyranoquinoline dicarboxylic acid derivative.1 2 3 4 5 6 7 9 10 11 1 2 3 9 10 11
Uses for Tilade
Asthma
Used as an adjunct in the overall management of mild to moderate bronchial asthma.1 2 3 4 5 9 10 11 a
For prophylaxis only; not indicated for reversal of acute bronchospasm, including status asthmaticus.a 1 9 10 (See Acute Bronchospasm under Warnings.)
Tilade Dosage and Administration
General
Initially, administer concurrently with patient’s existing maintenance dosages of β-adrenergic agonists, theophylline, and/or corticosteroids.a 1 2 4 5 Once clinical response is observed and asthma adequately controlled, gradual reduction in concomitant therapy may be possible.a 1 2 4 5
Administration
Oral Inhalation
Administer by oral inhalation using an oral aerosol inhaler.1
Shake inhaler well before use.1 8 Actuate aerosol inhaler 3 times prior to the initial use or if it has not been used for >7 days.a
Exhale slowly and completely, invert the inhaler, place the mouthpiece of the inhaler well into the mouth, and close the lips around it.8 Inhale slowly and deeply through the mouth while actuating the inhaler.8 Hold breath for 5–10 seconds, withdraw the mouthpiece, and exhale slowly.2 8
Avoid spraying in eyes.a
Clean inhaler twice weekly. Remove metal canister and cap and rinse plastic mouthpiece in hot running water. Allow to dry overnight in a warm place.a 8
Optimal therapeutic effect is dependent upon administration at regular intervals, even during symptom-free periods.a
Dosage
Available as nedocromil sodium, dosage expressed in terms of the salt.a 1
The dose of nedocromil sodium is expressed as the amount delivered from the actuator of the inhaler per metered spray.a
Oral inhalation aerosol delivers 2 mg from the valve and 1.75 mg from the actuator per metered spray.a Each aerosol canister delivers ≥104 metered sprays.a 1
Pediatric Patients
Asthma
Oral Inhalation
Children ≥6 years of age: 3.5 mg (2 inhalations) 4 times daily at regular intervals (14 mg/day).1
Less frequent administration may be effective if asthma is well controlled at this dose (e.g., patients only need occasional β-agonist therapy and are not experiencing serious exacerbations).a
Adults
Asthma
Oral Inhalation
3.5 mg (2 inhalations) 4 times daily at regular intervals (14 mg/day).1
Less frequent administration may be effective if asthma is well controlled at this dose (e.g., patients only need occasional β-agonist therapy and are not experiencing serious exacerbations).a
Prescribing Limits
Pediatric Patients
Asthma
Oral Inhalation
Children ≥6 years of age: Maximum 3.5 mg (2 inhalations) 4 times daily (14 mg/day).1
Adults
Asthma
Oral Inhalation
Maximum 3.5 mg (2 inhalations) 4 times daily (14 mg/day).a 1
Special Populations
No special population dosage recommendations at this time.a
Cautions for Tilade
Contraindications
Known hypersensitivity to nedocromil or any ingredient in the formulation.a
Warnings/Precautions
Warnings
Acute Bronchospasm
Nedocromil is not a bronchodilator; do not use for reversal of acute bronchospasm, especially status asthmaticus.1 9 10 a
Use should generally be continued during acute exacerbations, unless patient becomes intolerant to use of inhaled dosage forms.a
Bronchospasm, possibly life-threatening, may occur immediately after administration.a If this occurs, discontinue nedocromil and institute alternative therapy.a
General Precautions
Concomitant Corticosteroid Dosage
Role of nedocromil as a corticosteroid-sparing agent in patients receiving oral or inhaled corticosteroids not defined.a Monitor patients closely if systemic or inhaled corticosteroids are reduced.a
Specific Populations
Pregnancy
Category B.a
Lactation
Not known if nedocromil is distributed into milk.a Caution is advised if nedocromil is used.a
Pediatric Use
Safety and efficacy not established in children <6 years of age.a
Common Adverse Effects
Unpleasant taste, coughing, pharyngitis, rhinitis, upper respiratory infection, dyspnea, bronchospasm, sinusitis, nausea, vomiting, headache, chest pain, fever, viral infection.a
Interactions for Tilade
No formal drug interaction studies to date.a
Tilade Pharmacokinetics
Absorption
Bioavailability
Absolute bioavailability is 8 and 17% for single and multiple inhaled doses, respectively.a
Onset
Full therapeutic effect may not be obtained for ≥1 week.a
Distribution
Plasma Protein Binding
89%.a
Elimination
Elimination Route
Excreted principally in urine as unchanged drug.a
Half-life
3.3 hours.a
Special Populations
Pharmacokinetics in children 6–11 years of age appear similar to those in adults.a
Stability
Storage
Oral Inhalation
Aerosol, Solution for Inhalation
2–30°C.a Do not freeze.a
Temperatures >120°F may cause aerosol canister to burst.a
Actions
Inhibits acute bronchoconstrictor response and delayed inflammatory response.a 1 2 6 9 10 11
In vitro, inhibits eosinophils, neutrophils, macrophages, mast cells, monocytes, platelets,a 1 2 3 9 10 11 histamine, leukotriene C4, and prostaglandin D2.a 1 2 3 5 6
Inhibits bronchoconstriction caused by sulfur dioxide, inhaled neurokinin A, various antigens, exercise, cold air, fog, and adenosine monophosphate.a
Exhibits no bronchodilator, antihistamine, or corticosteroid activity.a
Exhibits cough suppression resulting from inhibition of neuronal reflexes in airways.2 6 9 10
Advice to Patients
Importance of providing patient a copy of manufacturer’s patient information.a
Importance of adequate understanding of proper storage, preparation, disposal, and inhalation technique.a
Importance of adherence to dosing schedules, even during symptom-free periods, and of not changing dose unless otherwise instructed by a clinician.a
Importance of notifying physician immediately if symptoms do not improve or condition worsens.a
Importance of women informing clinicians if they are or plan to become pregnant or plan to breast-feed.a
Importance of informing clinicians of existing or contemplated concomitant therapy, including prescription and OTC drugs.a
Importance of informing patients of other important precautionary information.a (See Cautions.)
Preparations
Excipients in commercially available drug preparations may have clinically important effects in some individuals; consult specific product labeling for details.
Routes | Dosage Forms | Strengths | Brand Names | Manufacturer |
|---|---|---|---|---|
Oral Inhalation | Aerosol | 1.75 mg/metered spray (from the mouthpiece) | Tilade Inhaler (with chlorofluorohydrocarbon propellants) | Monarch |
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, 1959-2010, Selected Revisions May 2007. American Society of Health-System Pharmacists, Inc., 7272 Wisconsin Avenue, Bethesda, Maryland 20814.
References
1. Aventis. Tilade (nedocromil sodium) inhalation aerosol prescribing information. Kansas City, MO; 1999 Oct.
2. Gonzalez JP, Brogden RN. Nedocromil sodium: a preliminary review of its pharmacodynamic and pharmacokinetic properties, and therapeutic efficacy in the treatment of reversible obstructive airways disease. Drugs. 1987; 34:560-77. [IDIS 236663] [PubMed 2826101]
3. Rebuck AS, Kesten S, Boulet LP et al. A 3-month evaluation of the efficacy of nedocromil sodium in asthma: a randomized, double-blind, placebo-controlled trial of nedocromil sodium conducted by a Canadian multicenter study group. J Allergy Clin Immunol. 1990; 85:612-7. [IDIS 314389] [PubMed 2155958]
4. Callaghan B, Teo NC, Clancy L. Effects of the addition of nedocromil sodium to maintenance bronchodilator therapy in the management of chronic asthma. Chest. 1992; 101:787-92. [IDIS 293018] [PubMed 1311666]
5. Cherniack RM, Wasserman SI, Ramsdell JW et al. A double-blind multicenter group comparative study of the efficacy and safety of nedocromil sodium in the management of asthma. Chest. 1990; 97:1299-1306. [IDIS 289144] [PubMed 2161328]
6. Tandon MK. Double-blind crossover study of nedocromil sodium in partially reversible chronic obstructive airways disease. Chest. 1993; 103:105-10. [IDIS 308235] [PubMed 8380266]
7. Morton AR, Ogle SL, Fitch KD. Effects of nedocromil sodium, cromolyn sodium, and a placebo in exercise-induced asthma. Ann Allergy. 1992; 68:143-8. [IDIS 292497] [PubMed 1310834]
8. Fisons. Tilade (nedocromil sodium) inhalation aerosol patient information. (undated)
9. Anon. Nedocromil for asthma. Med Lett Drugs Ther. 1993; 35:62-3. [PubMed 8390598]
10. Parish RC, Miller LJ. Nedocromil sodium. Ann Pharmacother. 1993; 27:599-606. [IDIS 314179] [PubMed 8394165]
11. Lal S, Dorow PD, Venho KK et al. Nedocromil sodium is more effective than cromolyn sodium for the treatment of chronic reversible obstructive airway disease. Chest. 1993; 104:438-47. [IDIS 319804] [PubMed 8393398]
12. Fisons Pharmaceuticals, Rochester, NY: Personal communication.
13. National Asthma Education and Prevention Program. Expert panel report II: guidelines for the diagnosis and management of asthma. 1997 Feb.
14. Kemp JP. Comprehensive asthma management: guidelines for clinicians. J Asthma. 1998; 35:601-20. [PubMed 9860081]
15. Kemp JP. Guidelines update: where do the new therapies fit in the management of asthma? Drugs. 2000; 59(Suppl 1):23-8.
a. King Pharmaceuticals. Tilade (nedocromil sodium) inhalation aerosol prescribing information. Bristol, TN; 2004 July.
More Tilade resources
- Tilade Side Effects (in more detail)
- Tilade Use in Pregnancy & Breastfeeding
- Tilade Drug Interactions
- Tilade Support Group
- 0 Reviews for Tilade - Add your own review/rating
- Tilade Prescribing Information (FDA)
- Tilade Concise Consumer Information (Cerner Multum)
- Tilade Advanced Consumer (Micromedex) - Includes Dosage Information
- Tilade Aerosol MedFacts Consumer Leaflet (Wolters Kluwer)
Compare Tilade with other medications
- Asthma, Maintenance
Thursday, September 29, 2016
Brisair
Brisair may be available in the countries listed below.
Ingredient matches for Brisair
Fluticasone
Fluticasone propionate (a derivative of Fluticasone) is reported as an ingredient of Brisair in the following countries:
- Spain
Salmeterol
Salmeterol xinafoate (a derivative of Salmeterol) is reported as an ingredient of Brisair in the following countries:
- Spain
International Drug Name Search
narcotic analgesics and acetaminophen Oral
Class Name: narcotic analgesics and acetaminophen (Oral route)
Commonly used brand name(s):
In the U.S.
- APAP w/Codeine
- Capital w/Codeine
- Darvocet A500
- Darvocet-N 100
- Darvocet-N 50
- Endocet
- Lorcet
- Lortab
- Panlor-DC
- Panlor-SS
- Percocet
- Pyregesic-C
- Roxicet
- Vicodin
- Zerlor
Available Dosage Forms:
- Tablet
- Solution
- Elixir
- Capsule
- Liquid
- Syrup
- Suspension
Uses For This Medicine
Combination medicines containing narcotic analgesics and acetaminophen are used to relieve pain. A narcotic analgesic and acetaminophen used together may provide better pain relief than either medicine used alone. In some cases, relief of pain may come at lower doses of each medicine.
Narcotic analgesics act in the central nervous system (CNS) to relieve pain. Many of their side effects are also caused by actions in the CNS. When narcotics are used for a long time, your body may get used to them so that larger amounts are needed to relieve pain. This is called tolerance to the medicine. Also, when narcotics are used for a long time or in large doses, they may become habit-forming (causing mental or physical dependence). Physical dependence may lead to withdrawal symptoms when you stop taking the medicine.
Acetaminophen does not become habit-forming when taken for a long time or in large doses, but it may cause other unwanted effects, including liver damage, if too much is taken.
These medicines are available only with your doctor's prescription. In Canada, some acetaminophen, codeine, and caffeine combinations are available without a prescription.
Before Using This Medicine
Allergies
Tell your doctor if you have ever had any unusual or allergic reaction to medicines in this group 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
Breathing problems may be especially likely to occur when narcotic analgesics are given to children younger than 2 years of age. These children are usually more sensitive than adults to the effects of narcotic analgesics. Also, unusual excitement or restlessness may be more likely to occur in children receiving these medicines.
Acetaminophen has been tested in children and has not been shown to cause different side effects or problems in children than it does in adults.
Geriatric
Elderly people are especially sensitive to the effects of narcotic analgesics. This may increase the chance of side effects, especially breathing problems, during treatment.
Acetaminophen has been tested and has not been shown to cause different side effects or problems in older people than it does in younger adults.
Pregnancy
For acetaminophen—Although studies on birth defects with acetaminophen have not been done in pregnant women, it has not been reported to cause birth defects or other problems.
For narcotic analgesics—Although studies on birth defects with narcotic analgesics have not been done in pregnant women, they have not been reported to cause birth defects. However, hydrocodone caused birth defects in animal studies when very large doses were used. Codeine did not cause birth defects in animals, but it caused slower development of bones and other toxic or harmful effects in the fetus. Pentazocine and propoxyphene did not cause birth defects in animals. There is no information about whether dihydrocodeine or oxycodone causes birth defects in animals.
Too much use of a narcotic during pregnancy may cause the fetus to become dependent on the medicine. This may lead to withdrawal side effects in the newborn baby. Also, some of these medicines may cause breathing problems in the newborn baby if taken just before or during delivery.
For caffeine—Studies in humans have not shown that caffeine (contained in some of these combination medicines) causes birth defects. However, studies in animals have shown that caffeine causes birth defects when given in very large doses (amounts equal to those present in 12 to 24 cups of coffee a day).
Breast Feeding
Most of these medicines have not been reported to cause problems in nursing babies.
For acetaminophen and propoxyphene—These medicines do pass into the breast milk.
For codeine and other narcotic analgesics (e.g., dihydrocodeine, hydrocodone, oxycodone, and pentazocine)—Codeine is changed to morphine in the body. Some people change codeine to morphine more quickly than others. These individuals are called "ultra-rapid metabolizers of codeine". If a nursing mother is an ultra-rapid metabolizer of codeine, it could lead to a morphine overdose in the nursing baby and cause very serious side effects. A nursing mother should talk to her doctor if she has any questions about taking codeine or about how this medicine may affect her baby .
Interactions with Medicines
Using medicines in this class 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.
- Fospropofol
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 medicines in this class with any of the following is usually not recommended, but may be unavoidable in some cases. If used together, your doctor may change the dose or how often you use your 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 medicines in this class. Make sure you tell your doctor if you have any other medical problems, especially:
- Alcohol and/or other drug abuse, or history of, or
- Brain disease or head injury or
- Colitis or
- Convulsions (seizures), history of, or
- Emotional problems or mental illness or
- Emphysema, asthma, or other chronic lung disease or
- Hepatitis or other liver disease or
- Kidney disease or
- Underactive thyroid—The chance of serious side effects may be increased.
- Enlarged prostate or problems with urination or
- Gallbladder disease or gallstones—Some of the effects of narcotic analgesics may be especially serious in people with these medical problems.
- Heart disease—Caffeine (present in some of these combination medicines) can make some kinds of heart disease worse.
Proper Use of This Medicine
Take this medicine only as directed by your medical doctor or dentist. Do not take more of it, do not take it more often, and do not take it for a longer time than your medical doctor or dentist ordered. This is especially important for young children and elderly patients, who may be more sensitive than other people to the effects of narcotic analgesics. If too much of a narcotic analgesic is taken, it may become habit-forming (causing mental or physical dependence) or lead to medical problems because of an overdose. Taking too much acetaminophen may cause liver damage.
If you think that this medicine is not working properly after you have been taking it for a few weeks, do not increase the dose. Instead, check with your medical doctor or dentist.
Dosing
The dose medicines in this class 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 these medicines. 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 acetaminophen and codeine
- For oral dosage forms (capsules or tablets):
- For pain:
- Adults—1 or 2 capsules or tablets containing acetaminophen with 15 or 30 milligrams (mg) of codeine, or 1 capsule or tablet containing acetaminophen with 60 mg of codeine, every four hours as needed.
- Children—Dose must be determined by the doctor, depending on the age of the child. Most young children will receive the oral solution or suspension, rather than tablets or capsules.
- For pain:
- For oral dosage forms (solution or suspension):
- For pain:
- Adults—1 tablespoonful (3 teaspoonfuls) every four hours as needed.
- Children 7 to 12 years of age—2 teaspoonfuls three or four times a day as needed.
- Children 3 to 7 years of age—1 teaspoonful three or four times a day as needed.
- Children younger than 3 years of age—Dose must be determined by your doctor.
- For pain:
- For acetaminophen, codeine, and caffeine
- For oral dosage form (tablets):
- For pain:
- Adults—1 or 2 tablets every four hours as needed.
- Children—Dose must be determined by your doctor.
- For pain:
- For dihydrocodeine, acetaminophen, and caffeine
- For oral dosage form (capsules):
- For pain:
- Adults—2 capsules every four hours.
- Children—Dose must be determined by your doctor.
- For pain:
- For hydrocodone and acetaminophen
- For oral dosage form (capsules):
- For pain:
- Adults—1 capsule every four to six hours as needed.
- Children—Dose must be determined by your doctor.
- For pain:
- For oral dosage form (oral solution):
- For pain:
- Adults—1 to 3 teaspoonfuls every four to six hours as needed.
- Children—Dose must be determined by your doctor.
- For pain:
- For oral dosage form (tablets):
- For pain:
- Adults—1 or 2 tablets containing acetaminophen with 2.5 milligrams (mg) of hydrocodone, or 1 tablet containing acetaminophen with 5, 7.5, or 10 mg of hydrocodone, every four to six hours as needed.
- Children—Dose must be determined by your doctor.
- For pain:
- For oxycodone and acetaminophen
- For oral dosage form (solution):
- For pain:
- Adults—1 teaspoonful every four to six hours as needed.
- Children—Dose must be determined by your doctor.
- For pain:
- For pentazocine and acetaminophen
- For oral dosage form (tablets):
- For pain:
- Adults—1 tablet every four hours.
- Children—Dose must be determined by your doctor.
- For pain:
- For propoxyphene and acetaminophen
- For oral dosage form (tablets):
- For pain:
- Adults—1 or 2 tablets, depending on the strength, every four hours as needed.
- Children—Dose must be determined by your doctor.
- For pain:
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
Keep out of the reach of children.
Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.
Do not keep outdated medicine or medicine no longer needed.
Precautions While Using This Medicine
If you will be taking this medicine for a long time (for example, for several months at a time), or in high doses, 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 acetaminophen or a narcotic be especially careful, since taking them while taking this medicine may lead to overdose. If you have any questions about this, check with your medical doctor, dentist, or pharmacist.
For patients taking a codeine-containing medicine or any other narcotic analgesics (e.g., dihydrocodeine, hydrocodone, oxycodone, and pentazocine):
- Contact your doctor immediately if you experience extreme sleepiness, confusion, or shallow breathing. These symptoms may indicate that you are an "ultra-rapid metabolizer of codeine". Ultra-rapid metabolizers change codeine to morphine more quickly and completely than other people. As a result, there is too much morphine in the body and more side effects of morphine than usual
For nursing mothers taking a codeine-containing medicine or any other narcotic analgesic (dihydrocodeine, hydrocodone, oxycodone, or pentazocine):
- Call your doctor if you become extremely tired and have difficulty caring for your baby.
- Your baby should generally nurse every two to three hours and should not sleep more than four hours at a time.
- Check with your doctor or hospital emergency room immediately if your baby shows signs of increased sleepiness (more than usual), difficulty breast-feeding, difficulty breathing, or limpness. These may be symptoms of an overdose and need immediate medical attention .
The narcotic analgesic in this medicine will add to the effects of alcohol and other central nervous system (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; other prescription pain medicine or narcotics; barbiturates; medicine for seizures; muscle relaxants; or anesthetics, including some dental anesthetics. Also, there may be a greater risk of liver damage if you drink three or more alcoholic beverages while you are taking acetaminophen. Do not drink alcoholic beverages, and check with your medical doctor or dentist before taking any of the medicines listed above, while you are using this medicine.
Too much use of the acetaminophen in this combination medicine together with certain other medicines may increase the chance of unwanted effects. The risk will depend 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 this medicine together with any of the following medicines for more than a few days, unless your doctor has directed you to do so and is following your progress:
- Aspirin or other salicylates
- 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)
- 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)
This medicine may cause some people to become drowsy, dizzy, light-headed, or to feel a false sense of well-being. 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 and clearheaded.
Dizziness, light-headedness, or fainting may occur, especially when you get up suddenly from a lying or sitting position. Getting up slowly may help lessen this problem.
Nausea or vomiting may occur, especially after the first couple of doses. This effect may go away if you lie down for a while. However, if nausea or vomiting continues, check with your medical doctor or dentist. Lying down for a while may also help relieve some other side effects, such as dizziness or light-headedness, that may occur.
Before having any kind of surgery (including dental surgery) or emergency treatment, tell the medical doctor or dentist in charge that you are taking this medicine.
Narcotic analgesics may cause dryness of the mouth. 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 have been taking this medicine regularly for several weeks or more, do not suddenly stop taking it without first checking with your doctor. Your doctor may want you to reduce gradually the amount you are taking before stopping completely, to lessen the chance of withdrawal side effects. This will depend on which of these medicines you have been taking, and the amount you have been taking every day.
If you think you or someone else may have taken an overdose of this medicine, get emergency help at once. Taking an overdose of this medicine or taking alcohol or CNS depressants with this medicine may lead to unconsciousness or death. Signs of overdose of narcotics include convulsions (seizures), confusion, severe nervousness or restlessness, severe dizziness, severe drowsiness, shortness of breath or troubled breathing, and severe weakness. Signs of severe acetaminophen overdose may not occur until several days after the overdose is taken.
Flush unused, unneeded, or expired oxycodone/acetaminophen (Percocet(R)) down the toilet. Otherwise, do not flush your medicine down the toilet to dispose of it unless the medicine label or patient information specifically instructs you to do so. If you are unsure about how to dispose of your prescription medication, contact your pharmacist or doctor.
Side Effects of This Medicine
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:
If you are a nursing mother and you notice any of the following symptoms of overdose in your baby, get emergency help immediately:
- Cold, clammy skin
- confusion (severe)
- convulsions (seizures)
- diarrhea
- dizziness (severe)
- drowsiness (severe)
- increased sweating
- low blood pressure
- nausea or vomiting (continuing)
- nervousness or restlessness (severe)
- pinpoint pupils of eyes
- shortness of breath or unusually slow or troubled breathing
- slow heartbeat
- stomach cramps or pain
- weakness (severe)
- Difficulty breathing
- difficulty nursing
- increased sleepiness (more than usual)
- limpness
Check with your doctor as soon as possible if any of the following side effects occur:
Less common or rare
- Black, tarry stools
- bloody or cloudy urine
- confusion
- dark urine
- difficult or painful urination
- fast, slow, or pounding heartbeat
- frequent urge to urinate
- hallucinations (seeing, hearing, or feeling things that are not there)
- increased sweating
- irregular breathing or wheezing
- mental depression
- pain in lower back and/or side (severe and/or sharp)
- pale stools
- pinpoint red spots on skin
- redness or flushing of face
- ringing or buzzing in ears
- skin rash, hives, or itching
- sore throat and fever
- sudden decrease in amount of urine
- swelling of face
- trembling or uncontrolled muscle movements
- unusual bleeding or bruising
- unusual excitement (especially in children)
- yellow eyes or skin
Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:
More common
- Dizziness, light-headedness, or feeling faint
- drowsiness
- nausea or vomiting
- unusual tiredness or weakness
- Blurred or double vision or other changes in vision
- constipation (more common with long-term use and with codeine or meperidine)
- dry mouth
- false sense of well-being
- general feeling of discomfort or illness
- headache
- loss of appetite
- nervousness or restlessness
- nightmares or unusual dreams
- trouble in sleeping
Although not all of the side effects listed above have been reported for all of these combination medicines, they have been reported for at least one of them. However, since all of the narcotic analgesics are very similar, any of the above side effects may occur with any of these medicines.
After you stop using this medicine, your body may need time to adjust. The length of time this takes depends on which of these medicines you were taking, the amount of medicine you were using, and how long you used it. During this time check with your doctor if you notice any of the following side effects:
- Body aches
- diarrhea
- fast heartbeat
- fever, runny nose, or sneezing
- gooseflesh
- increased sweating
- increased yawning
- loss of appetite
- nausea or vomiting
- nervousness, restlessness, or irritability
- shivering or trembling
- stomach cramps
- trouble in sleeping
- weakness
Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.
Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.
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Tranexamic Acid Injection
Each mL of the sterile solution for intravenous injection contains Tranexamic Acid 100 mg and Water for Injection to 1 mL.
Formulation
Chemical Name: trans-4-(aminomethyl) cyclohexanecarboxylic acid.
Structural Formula:
Tranexamic acid is a white crystalline powder. The aqueous solution for injection has a pH of 6.5 to 8.0.
CLINICAL PHARMACOLOGY
Tranexamic acid is a competitive inhibitor of plasminogen activation, and at much higher concentrations, a noncompetitive inhibitor of plasmin, i.e., actions similar to aminocaproic acid. Tranexamic acid is about 10 times more potent in vitro than aminocaproic acid.
Tranexamic acid binds more strongly than aminocaproic acid to both the strong and weak receptor sites of the plasminogen molecule in a ratio corresponding to the difference in potency between the compounds. Tranexamic acid in a concentration of 1 mg per mL does not aggregate platelets in vitro.
Tranexamic acid in concentrations up to 10 mg per mL blood has no influence on the platelet count, the coagulation time, or various coagulation factors in whole blood or citrated blood from normal subjects. On the other hand, tranexamic acid in concentrations of 10 mg and 1 mg per mL blood prolongs the thrombin time.
The plasma protein binding of tranexamic acid is about 3% at therapeutic plasma levels and seems to be fully accounted for by its binding to plasminogen. Tranexamic acid does not bind to serum albumin.
After an intravenous dose of 1 g, the plasma concentration time curve shows a triexponential decay with a half-life of about 2 hours for the terminal elimination phase. The initial volume of distribution is about 9 to 12 liters. Urinary excretion is the main route of elimination via glomerular filtration. Overall renal clearance is equal to overall plasma clearance (110 to 116 mL/min), and more than 95% of the dose is excreted in the urine as the unchanged drug. Excretion of tranexamic acid is about 90% at 24 hours after intravenous administration of 10 mg per kg body weight.
An antifibrinolytic concentration of tranexamic acid remains in different tissues for about 17 hours, and in the serum, up to seven or eight hours.
Tranexamic acid passes through the placenta. The concentration in cord blood after an intravenous injection of 10 mg per kg to pregnant women is about 30 mg per liter, as high as in the maternal blood. Tranexamic acid diffuses rapidly into joint fluid and the synovial membrane. In the joint fluid, the same concentration is obtained as in the serum. The biological half-life of tranexamic acid in the joint fluid is about three hours.
The concentration of tranexamic acid in a number of other tissues is lower than in blood. In breast milk, the concentration is about one hundredth of the serum peak concentration. Tranexamic acid concentration in cerebrospinal fluid is about one tenth of that of the plasma. The drug passes into the aqueous humor, the concentration being about one tenth of the plasma concentration.
Tranexamic acid has been detected in semen where it inhibits fibrinolytic activity but does not influence sperm migration.
INDICATIONS AND USAGE
Tranexamic Acid Injection is indicated in patients with hemophilia for short-term use (two to eight days) to reduce or prevent hemorrhage and reduce the need for replacement therapy during and following tooth extraction.
CONTRAINDICATIONS
Tranexamic Acid Injection is contraindicated:
- In patients with acquired defective color vision, since this prohibits measuring one endpoint that should be followed as a measure of toxicity (see WARNINGS).
- In patients with subarachnoid hemorrhage. Anecdotal experience indicates that cerebral edema and cerebral infarction may be caused by Tranexamic Acid Injection in such patients.
- In patients with active intravascular clotting.
- In patients with hypersensitivity to tranexamic acid or any of the ingredients
WARNINGS
Focal areas of retinal degeneration have developed in cats, dogs and rats following oral or intravenous tranexamic acid at doses between 250 to 1600 mg/kg/day (6 to 40 times the recommended usual human dose) from 6 days to 1 year. The incidence of such lesions has varied from 25% to 100% of animals treated and was dose-related. At lower doses, some lesions have appeared to be reversible.
Limited data in cats and rabbits showed retinal changes in some animals with doses as low as 126 mg/kg/day (only about 3 times the recommended human dose) administered for several days to two weeks.
No retinal changes have been reported or noted in eye examinations in patients treated with tranexamic acid for weeks to months in clinical trials.
However, visual abnormalities, often poorly characterized, represent the most frequently reported postmarketing adverse reaction in Sweden. For patients who are to be treated continually for longer than several days, an ophthalmological examination, including visual acuity, color vision, eye-ground and visual fields, is advised, before commencing and at regular intervals during the course of treatment. Tranexamic acid should be discontinued if changes in examination results are found.
Convulsions have been reported in association with tranexamic acid treatment.
PRECAUTIONS
General
The dose of Tranexamic Acid Injection should be reduced in patients with renal insufficiency because of the risk of accumulation. (See DOSAGE AND ADMINISTRATION.)
Ureteral obstruction due to clot formation in patients with upper urinary tract bleeding has been reported in patients treated with Tranexamic Acid Injection.
Venous and arterial thrombosis or thromboembolism has been reported in patients treated with Tranexamic Acid Injection. In addition, cases of central retinal artery and central retinal vein obstruction have been reported.
Patients with a previous history of thromboembolic disease may be at increased risk for venous or arterial thrombosis.
Tranexamic Acid Injection should not be administered concomitantly with Factor IX Complex concentrates or Anti-inhibitor Coagulant concentrates, as the risk of thrombosis may be increased.
Patients with disseminated intravascular coagulation (DIC), who require treatment with Tranexamic Acid Injection, must be under strict supervision of a physician experienced in treating this disorder.
Tranexamic acid may cause dizziness and therefore may influence the ability to drive or use machines.
Drug Interactions
No studies of interaction between tranexamic acid and other drugs have been conducted.
Carcinogenesis, Mutagenesis, Impairment of Fertility
An increased incidence of leukemia in male mice receiving tranexamic acid in food at a concentration of 4.8% (equivalent to doses as high as 5 g/kg/day) may have been related to treatment. Female mice were not included in this experiment.
Hyperplasia of the biliary tract and cholangioma and adenocarcinoma of the intrahepatic biliary system have been reported in one strain of rats after dietary administration of doses exceeding the maximum tolerated dose for 22 months. Hyperplastic, but not neoplastic, lesions were reported at lower doses. Subsequent long-term dietary administration studies in a different strain of rat, each with an exposure level equal to the maximum level employed in the earlier experiment, have failed to show such hyperplastic / neoplastic changes in the liver. No mutagenic activity has been demonstrated in several in vitro and in vivo test systems.
There are no clinical or nonclinical data to assess the effects of tranexamic acid on fertility.
Pregnancy
(Category B)
Reproduction studies performed in mice, rats, and rabbits have not revealed any evidence of impaired fertility or adverse effects on the fetus due to tranexamic acid.
There are no adequate and well-controlled studies in pregnant women. However, tranexamic acid is known to pass the placenta and appears in cord blood at concentrations approximately equal to maternal concentration. Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed.
Labor and Delivery
See above under Pregnancy.
Nursing Mothers
Tranexamic acid is present in the mother's milk at a concentration of about a hundredth of the corresponding serum levels. Caution should be exercised when Tranexamic Acid Injection is administered to a nursing woman.
Pediatric Use
The drug has had limited use in pediatric patients, principally in connection with tooth extraction. The limited data suggest that dosing instructions for adults can be used for pediatric patients needing Tranexamic Acid Injection therapy.
Geriatric Use
Clinical studies of Tranexamic Acid Injection 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 (see CLINICAL PHARMACOLOGY and DOSAGE AND ADMINISTRATION).
ADVERSE REACTIONS
Gastrointestinal disturbances (nausea, vomiting, diarrhea) may occur but disappear when the dosage is reduced. Allergic dermatitis, giddiness and hypotension have been reported occasionally. Hypotension has been observed when intravenous injection is too rapid. To avoid this response, the solution should not be injected more rapidly than 1 mL per minute.
Worldwide Postmarketing Reports
Thromboembolic events (e.g., deep vein thrombosis, pulmonary embolism, cerebral thrombosis, acute renal cortical necrosis, and central retinal artery and vein obstruction) have been rarely reported in patients receiving tranexamic acid for indications other than hemorrhage prevention in patients with hemophilia. Convulsion, chromatopsia, and visual impairment have also been reported. However, due to the spontaneous nature of the reporting of medical events and the lack of controls, the actual incidence and causal relationship of drug and event cannot be determined.
OVERDOSAGE
Cases of overdosage of Tranexamic Acid Injection have been reported. Based on these reports, symptoms of overdosage may be gastrointestinal, e.g., nausea, vomiting, diarrhea; hypotensive, e.g., orthostatic symptoms; thromboembolic, e.g., arterial, venous, embolic; visual impairment; convulsions; mental status changes; myoclonus, and rash.
DOSAGE AND ADMINISTRATION
Immediately before tooth extraction in patients with hemophilia, administer 10 mg per kg body weight of Tranexamic Acid Injection intravenously together with replacement therapy (see PRECAUTIONS). Following tooth extraction, intravenous therapy, at a dose of 10 mg per kg body weight three to four times daily, may be used for 2 to 8 days.
Note: For patients with moderate to severe impaired renal function, the following dosages are recommended:
| Serum Creatinine (μmol/L) | Tranexamic Acid I.V. Dosage |
| 120 to 250 (1.36 to 2.83 mg/dL) | 10 mg/kg BID |
| 250 to 500 (2.83 to 5.66 mg/dL) | 10 mg/kg daily |
| >500 (>5.66 mg/dL) | 10 mg/kg every 48 hours or 5 mg/kg every 24 hours |
For intravenous infusion, Tranexamic Acid Injection may be mixed with most solutions for infusion such as electrolyte solutions, carbohydrate solutions, amino acid solutions, and Dextran solutions. The mixture should be prepared the same day the solution is to be used. Heparin may be added to Tranexamic Acid Injection. Tranexamic Acid Injection should NOT be mixed with blood. The drug is a synthetic amino acid, and should NOT be mixed with solutions containing penicillin.
HOW SUPPLIED
Tranexamic Acid Injection, 100 mg/mL, is a clear, colorless solution and is supplied in:
NDC 0517-0960-01 10 mL single dose vials packaged individually
NDC 0517-0960-10 10 mL single dose vials packaged in cartons of 10
STORAGE
Store at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) (See USP Controlled Room Temperature).
Discard unused portion.
AMERICAN
REGENT, INC.
SHIRLEY, NY 11967
Revised July 2011
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
Primary Display Panel – 10mL Label
NDC 0517-0960-01
TRANEXAMIC ACID
INJECTION
1000 mg/10 mL (100 mg/mL)
FOR INTRAVENOUS
USE ONLY
10mL SINGLE DOSE VIAL
Rx only
AMERICAN
REGENT, INC.
SHIRLEY, NY 11967
Primary Display Panel – 10 X 10mL Carton
NDC 0517-0960-01
Rx only
TRANEXAMIC ACID
INJECTION
1000 mg/10 mL(100 mg/mL)
FOR INTRAVENOUS USE
10 x 10mL SINGLE DOSE VIALS
AMERICAN
REGENT, INC.
SHIRLEY, NY 11967
| TRANEXAMIC ACID tranexamic acid injection, solution | ||||||||||||||||||||
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| Marketing Information | |||
| Marketing Category | Application Number or Monograph Citation | Marketing Start Date | Marketing End Date |
| ANDA | ANDA201885 | 11/15/2011 | |
| Labeler - American Regent, Inc. (622781813) |
| Registrant - PharmaForce, Inc. (113894740) |
| Establishment | |||
| Name | Address | ID/FEI | Operations |
| PharmaForce, Inc. | 113894740 | ANALYSIS | |
| Establishment | |||
| Name | Address | ID/FEI | Operations |
| PharmaForce, Inc. | 606821721 | MANUFACTURE | |
Tiapra
Tiapra may be available in the countries listed below.
Ingredient matches for Tiapra
Tiapride
Tiapride hydrochloride (a derivative of Tiapride) is reported as an ingredient of Tiapra in the following countries:
- Czech Republic
- Slovakia
International Drug Name Search
Wednesday, September 28, 2016
Magnesium Sulfate
Dosage Form: injection
Magnesium Sulfate INJECTION, USP 50%
Rx Only
2.03 mM/mL of Magnesium Sulfate Heptahydrate
Osmolarity 4.06 mOsmol/mL
MUST BE DILUTED PRIOR TO IV ADMINISTRATION
DESCRIPTION
Magnesium Sulfate Injection, USP (50%) for IV and IM use is a sterile concentrated solution of Magnesium Sulfate USP. Each mL contains: Magnesium Sulfate (Heptahydrate) 500 mg, which provides 4.06 mEq each of Magnesium (Mg++) and Sulfate (SO4=), Water for Injection q.s. The pH (5.5 - 7.0) is adjusted with Sulfuric Acid and/or Sodium Hydroxide. The solution contains no bacteriostatic agent or other preservatives. The molecular formula is MgSO4 • 7H2O and the molecular weight is 246.47.
CLINICAL PHARMACOLOGY
Magnesium is the second most plentiful cation of the intracellular fluids. It is essential for the activity of many enzyme systems and plays an important role with regard to neurochemical transmission and muscular excitability. Deficits are accompanied by a variety of structural and functional disturbances.
INDICATIONS AND USAGE
Magnesium Sulfate is indicated in the following conditions:
Convulsions (treatment) - Intravenous Magnesium Sulfate is indicated for immediate control of life-threatening convulsions in the treatment of severe toxemias (pre-eclampsia and eclampsia) of pregnancy and in the treatment of acute nephritis in children.
Hypomagnesemia (prophylaxis and treatment) - Magnesium Sulfate is indicated for replacement therapy in magnesium deficiency, especially in acute hypomagnesemia accompanied by signs of tetany similar to those of hypocalcemia.
Magnesium Sulfate is also used to prevent or treat magnesium deficiency in patients receiving total parenteral nutrition.
Tetany, uterine (treatment) - Magnesium Sulfate is indicated in uterine tetany as a myometrial relaxant.
CONTRAINDICATIONS
Magnesium Sulfate should not be administered parenterally in patients with heart block or myocardial damage.
WARNINGS
Magnesium Sulfate should be given very cautiously in the presence of serious impairment of renal function since it is excreted almost entirely by the kidneys.
The principle hazard in parenteral magnesium therapy is the production of abnormally high levels of magnesium in the plasma. Such high levels may cause flushing, sweating, hypotension, circulatory collapse and depression of cardiac and central nervous system function. The most immediate danger to life is respiratory depression.
During the period of parenteral therapy with magnesium salts, the patient should be watched carefully. A preparation of calcium, such as the gluconate or gluceptate should be at hand for intravenous administration as an antidote.
In the presence of severe renal insufficiency, no more than 20 grams of magnesium should be given within a forty-eight hour period. In eclampsia, however, renal function is not seriously impaired and magnesium may be more rapidly excreted.
This product contains aluminum that may be toxic. Aluminum may reach toxic levels with prolonged parenteral administration if kidney function is impaired. Premature neonates are particularly at risk because their kidneys are immature, and they require large amounts of calcium and phosphate solutions, which contain aluminum.
Research indicates that patients with impaired kidney function, including premature neonates, who receive parenteral levels of aluminum at greater than 4 to 5 mcg/kg/day accumulate aluminum at levels associated with central nervous system and bone toxicity. Tissue loading may occur at even lower rates of administration.
PRECAUTIONS
When barbiturates, narcotics, or other hypnotics (or systemic anesthetics) are to be given in conjunction with magnesium, their dosage should be adjusted with caution because of the additive central depressive effects of magnesium.
Pregnancy
Teratogenic Effects
Pregnancy category C. Animal reproduction studies have not been conducted with Magnesium Sulfate Injection, USP 50%. It is also not known whether Magnesium Sulfate Injection, USP 50% can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Magnesium Sulfate Injection, USP 50% should be given to a pregnant woman only if clearly needed.
ADVERSE REACTIONS
Flushing, sweating, sharply lowered blood pressure, hypothermia, stupor and ultimately, respiratory depression. Hypocalcemia with signs of tetany secondary to Magnesium Sulfate therapy for eclampsia has been reported.
DOSAGE AND ADMINISTRATION
Intramuscular: Adults and older children: For severe hypomagnesemia, 1 to 5 g (2 to 10 mL of 50% solution) daily in divided doses; administration is repeated daily until serum levels have returned to normal. If deficiency is not severe, 1 g (2 mL of 50% solution) can be given once or twice daily.Serum magnesium levels should serve as a guide to continued dosage.
Intravenous: 1 to 4 g Magnesium Sulfate may be given intravenously in 10% to 20% solution, but only with great caution; the rate should not exceed 1.5 mL of 10% solution or equivalent per minute until relaxation is obtained.
Intravenous Infusion: 4 g in 250 mL of 5% Dextrose Injection at a rate not exceeding 3 mL per minute.
Usual Dose Range: 1 to 40 g daily.
Electrolyte Replenisher: Intramuscular 1 to 2 g in 50% solution four times a day until serum magnesium is within normal limits.
Usual Pediatric Dose: Intramuscular 20 to 40 mg per kg of body weight in a 20% solution repeated as necessary.
For Eclampsia: Initially 1 to 2 g in 25% or 50% solution is given intramuscularly. Subsequently, 1 g is given every 30 minutes until relief is obtained. The blood pressure should be monitored after each injection.
Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.
HOW SUPPLIED
| Product No. | Vial Sizes | |
| NDC 0517-2602-25 | 2 mL Single Dose Vial | Boxes of 25 |
| NDC 0517-2610-25 | 10 mL Single Dose Vial | Boxes of 25 |
| NDC 0517-2650-25 | 50 mL Single Dose Vial | Boxes of 25 |
Store at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) (See USP Controlled Room Temperature).
Discard unused portion.
IN0291
Rev. 7/11
MG #7879
AMERICAN
REGENT, INC.
SHIRLEY, NY 11967
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
PRINCIPAL DISPLAY PANEL – 2 mL Container
NDC 0517-2602-25
Magnesium Sulfate INJECTION, USP
50% (0.5 g/mL)
1 gram/2 mL
(4.06 mEq/mL Magnesium)
2 mL SINGLE DOSE VIAL
FOR IM USE.
FOR IV USE AFTER DILUTION.
Rx Only
AMERICAN REGENT, INC.
SHIRLEY, NY 11967
Rev. 11/05
PRINCIPAL DISPLAY PANEL – 10 mL Container
NDC 0517-2610-25
Magnesium Sulfate INJECTION, USP
50% (0.5 g/mL)
5 grams/10 mL
(4.06 mEq/mL Magnesium)
10 mL SINGLE DOSE VIAL
FOR IM USE
FOR IV USE AFTER DILUTION
Rx Only
AMERICAN REGENT, INC.
SHIRLEY, NY 11967
Rev. 11/05
PRINCIPAL DISPLAY PANEL – 50 mL Container
NDC 0517-2650-25
Magnesium Sulfate INJECTION, USP
50% (0.5 g/mL)
25 grams/50 mL
(4.06 mEq/mL Magnesium)
50 mL SINGLE DOSE VIAL
FOR IM USE
FOR IV USE AFTER DILUTION
Rx Only
AMERICAN REGENT, INC.
SHIRLEY, NY 11967
Rev. 2/08
| Magnesium Sulfate Magnesium Sulfate injection, solution | ||||||||||||||||||||
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| Marketing Information | |||
| Marketing Category | Application Number or Monograph Citation | Marketing Start Date | Marketing End Date |
| Unapproved drug other | 09/30/1990 | ||
| Magnesium Sulfate Magnesium Sulfate injection, solution | ||||||||||||||||||||
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| Marketing Category | Application Number or Monograph Citation | Marketing Start Date | Marketing End Date |
| Unapproved drug other | 09/30/1990 | ||
| Magnesium Sulfate Magnesium Sulfate injection, solution | ||||||||||||||||||||
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| Marketing Information | |||
| Marketing Category | Application Number or Monograph Citation | Marketing Start Date | Marketing End Date |
| Unapproved drug other | 09/30/1990 | ||
| Labeler - American Regent, Inc. (622781813) |
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