Alti-Orciprenaline

Generic Name: metaproterenol (Oral route)

met-a-proe-TER-e-nol

Commonly used brand name(s)

In the U.S.

• Alupent

In Canada

• Alti-Orciprenaline

Available Dosage Forms:

• Syrup


• Tablet

Therapeutic Class: Bronchodilator

Pharmacologic Class: Beta-2 Adrenergic Agonist

Uses For Alti-Orciprenaline

Metaproterenol is used to treat asthma and bronchospasm in patients with bronchitis, emphysema, and other lung diseases.

Metaproterenol belongs to the family of medicines known as adrenergic bronchodilators. Adrenergic bronchodilators are medicines that open up the bronchial tubes (air passages) in the lungs. They relieve cough, wheezing, shortness of breath, and troubled breathing by increasing the flow of air through the bronchial tubes.

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

Before Using Alti-Orciprenaline

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

Appropriate studies have not been performed on the relationship of age to the effects of metaproterenol oral solution and tablets in children younger than 6 years of age. Safety and efficacy have not been established.

Geriatric

No information is available on the relationship of age to the effects of metaproterenol in geriatric patients.

Pregnancy

	Pregnancy Category	Explanation
All Trimesters	C	Animal studies have shown an adverse effect and there are no adequate studies in pregnant women OR no animal studies have been conducted and there are no adequate studies in pregnant women.

Breast Feeding

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Interactions with Medicines

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. 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 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.

• Acebutolol


• Alprenolol


• Arotinolol


• Atenolol


• Befunolol


• Betaxolol


• Bevantolol


• Bisoprolol


• Bopindolol


• Bucindolol


• Bupranolol


• Carteolol


• Carvedilol


• Celiprolol


• Dilevalol


• Esmolol


• Labetalol


• Landiolol


• Levobetaxolol


• Levobunolol


• Mepindolol


• Metipranolol


• Metoprolol


• Nadolol


• Nebivolol


• Nipradilol


• Oxprenolol


• Penbutolol


• Pindolol


• Propranolol


• Sotalol


• Talinolol


• Tertatolol


• Timolol

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other Medical Problems

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

• Diabetes or


• Heart or blood vessel disease or


• Hypertension (high blood pressure) or


• Hyperthyroidism (overactive thyroid) or


• Seizures—Use with caution. May make these conditions worse.

• Heart rhythm problems (e.g., arrhythmia) or


• Tachycardia (fast or rapid heartbeat)—Should not be used in patients with these conditions.

Proper Use of metaproterenol

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

Use this medicine only as directed by your doctor. Do not use more of it and do not use it more often than your doctor ordered. Also, do not stop using this medicine or any asthma medicine without telling your doctor. To do so may increase the chance for breathing problems.

Measure the oral liquid with a marked measuring spoon, oral syringe, or medicine cup. The average household teaspoon may not hold the right amount of liquid.

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 asthma and bronchospasm:
  
  • For oral dosage form (solution):
    
    • Adults—Two teaspoonfuls (10 milliliters [mL]) three or four times a day. Your doctor may adjust your dose as needed.
    
    
    • Children older than 9 years of age or weighing more than 60 pounds (lbs)—Two teaspoonfuls (10 mL) three or four times a day. Your doctor may adjust your dose as needed.
    
    
    • Children 6 to 9 years of age or weighing less than 60 lbs—One teaspoonful (5 mL) three or four times a day. Your doctor may adjust your dose as needed.
    
    
    • Children younger than 6 years of age—Use and dose must be determined by your child's doctor.
    
    
  
  
  • For oral dosage form (tablets):
    
    • Adults—20 milligrams (mg) three or four times a day. Your doctor may adjust your dose as needed.
    
    
    • Children older than 9 years of age or weighing more than 60 pounds (lbs)—20 mg three or four times a day. Your doctor may adjust your dose as needed.
    
    
    • Children 6 to 9 years of age or weighing less than 60 lbs—10 mg three or four times a day. Your doctor may adjust your dose as needed.
    
    
    • Children younger than 6 years of age—Use is not recommended.
    
    
  
  

Missed Dose

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

Storage

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

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

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

Precautions While Using Alti-Orciprenaline

It is very important that your doctor check your progress or your child's progress at regular visits. This will allow your doctor to see if the medicine is working properly and to check for any unwanted effects.

Check with your doctor at once if you or your child continue to have breathing problems after using a dose of this medicine or if your condition gets worse.

Do not change your dose or stop using this medicine without asking your doctor first.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines for appetite control, asthma, colds, cough, hay fever, or sinus problems, and herbal or vitamin supplements.

Alti-Orciprenaline Side Effects

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

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

More common

• Fast, pounding, or irregular heartbeat or pulse

Less common

• Shakiness in the legs, arms, hands, or feet


• trembling or shaking of the hands or feet


• worsening of asthma

Rare

• Blurred vision


• chest pain


• chills


• cough


• diarrhea


• dizziness


• fainting


• fever


• general feeling of discomfort or illness


• headache


• increased sweating


• joint pain


• loss of appetite


• muscle aches and pains


• nausea


• nervousness


• pounding in the ears


• puffiness of the face and fingers


• runny nose


• shivering


• slow or fast heartbeat


• sore throat


• sweating


• swelling


• trouble sleeping


• unusual tiredness or weakness


• vomiting

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

Symptoms of overdose

• Arm, back, or jaw pain


• chest discomfort


• chest tightness or heaviness


• confusion


• dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position


• dry mouth


• general feeling of discomfort or illness


• shortness of breath


• sleeplessness


• unable to sleep

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:

Less common

• Abdominal or stomach pain

Rare

• Bad, unusual, or unpleasant (after) taste


• change in appetite


• drowsiness


• dry mouth or throat


• itching skin


• pain


• raised red swellings on the skin, lips, tongue, or in the throat


• tightening of the muscles


• 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.

See also: Alti-Orciprenaline side effects (in more detail)

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.

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More Alti-Orciprenaline resources

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

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Levofloxacin

Pronunciation: LEE-voe-FLOX-a-sin
Generic Name: Levofloxacin
Brand Name: Levaquin

Levofloxacin is associated with an increased risk of tendon problems. These include pain, swelling, inflammation, and possible breakage of tendons. The risk of tendon problems is greater in patients who are older than 60 years, patients who take corticosteroids (eg, prednisone), and in those who have received kidney, heart, or lung transplants. The Achilles tendon in the back of the foot/ankle is most often affected. However, problems may also occur in other tendons (eg, in the shoulder, arm, or hand). Problems may occur while you take Levofloxacin or up to several months after you stop taking it.

Signs of tendon problems may include pain, soreness, redness, or swelling of a tendon or joint; bruising right after an injury in a tendon area; hearing or feeling a snap or pop in a joint or tendon area; or inability to move or bear weight on a joint or tendon area. Tell your doctor right away if you experience any of these symptoms while you take Levofloxacin or within several months after you stop taking it.

Levofloxacin may worsen muscle weakness and breathing problems in patients with myasthenia gravis. Do not take Levofloxacin if you have a history of myasthenia gravis.

Levofloxacin is used for:

Treating infections caused by certain bacteria. It may also be used to prevent or slow anthrax after exposure.

Levofloxacin is a quinolone antibiotic. It works by killing sensitive bacteria.

Do NOT use Levofloxacin if:

• you are allergic to any ingredient in Levofloxacin or to any other quinolone antibiotic (eg, ciprofloxacin)


• you have a certain type of irregular heartbeat (QT prolongation, long QT syndrome) or low blood potassium levels


• you have a history of myasthenia gravis


• you are taking cisapride or certain antiarrhythmics (eg, amiodarone, procainamide, quinidine, sotalol)

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

Before using Levofloxacin:

Some medical conditions may interact with Levofloxacin. Tell your health care provider if you have any medical conditions, especially if any of the following apply to you:

• if you are pregnant, planning to become pregnant, or are breast-feeding


• if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement


• if you have allergies to medicines, foods, or other substances


• if you have a history of severe or persistent diarrhea, skin sensitivity to the sun, diabetes, low blood potassium levels, chest pain, angina, heart problems (eg, enlarged heart, heart failure), a heart attack, irregular heartbeat (eg, QT prolongation), or if you have a family member with a history of fast, slow, or irregular heartbeat (eg, QT prolongation)


• if you have a stomach infection, liver problems, brain or nervous system problems, muscle problems (eg, myasthenia gravis), increased pressure in the brain, Alzheimer disease, brain blood vessel problems, or a history of seizures


• if you have a history of bone, joint, or tendon problems; rheumatoid arthritis; liver problems; kidney problems or decreased kidney function; or a heart, kidney, or lung transplant


• if you take corticosteroids (eg, prednisone) or participate in strenuous physical work or exercise

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

• Antiarrhythmics (eg, amiodarone , procainamide, quinidine, sotalol), arsenic, astemizole, cisapride, dofetilide, droperidol, haloperidol, imidazoles (eg, ketoconazole), macrolides (eg, erythromycin), methadone, paliperidone, phenothiazines (eg, chlorpromazine), pimozide, ranolazine, serotonin receptor antagonists (eg, dolasetron), telithromycin, terfenadine, or ziprasidone because the risk of serious heart problems, including irregular heartbeat, may be increased


• Insulin or oral diabetes medicines (eg, glyburide) because the risk of high or low blood sugar may be increased


• Corticosteroids (eg, prednisone) because the risk of tendon problems may be increased


• Anticoagulants (eg, warfarin) because the risk of bleeding may be increased


• Nonsteroidal anti-inflammatory drugs (NSAIDs) (eg, ibuprofen) or theophylline because the risk of serious side effects, including seizures, may be increased


• Serotonin-norepinephrine reuptake inhibitors (SNRIs) (eg, duloxetine) because the risk of their side effects may be increased by Levofloxacin

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

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

• Levofloxacin comes with an extra patient information sheet called a Medication Guide. Read it carefully. Read it again each time you get Levofloxacin refilled.


• Drinking extra fluids while you are taking Levofloxacin is recommended. Check with your doctor for instructions.


• Levofloxacin is usually given as an injection at your doctor's office, hospital, or clinic. If you will be using Levofloxacin at home, a health care provider will teach you how to use it. Be sure you understand how to use Levofloxacin. Follow the procedures you are taught when you use a dose. Contact your health care provider if you have any questions.


• Do not use Levofloxacin if it contains particles, is cloudy or discolored, or if the vial is cracked or damaged.


• Keep this product, as well as syringes and needles, out of the reach of children and pets. Do not reuse needles, syringes, or other materials. Ask your health care provider how to dispose of these materials after use. Follow all local rules for disposal.


• Levofloxacin works best if it is used at the same time each day.


• To clear up your infection completely, use Levofloxacin for the full course of treatment. Keep using it even if you feel better in a few days.


• Do not miss any doses of Levofloxacin. If you miss a dose of Levofloxacin, use it as soon as you remember. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not use 2 doses at once.

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

Important safety information:

• Levofloxacin may cause dizziness or light-headedness. These effects may be worse if you take it with alcohol or certain medicines. Use Levofloxacin with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.


• Mild diarrhea is common with antibiotic use. However, a more serious form of diarrhea (pseudomembranous colitis) may rarely occur. This may develop while you use the antibiotic or within several months after you stop using it. Contact your doctor right away if stomach pain or cramps, severe diarrhea, or bloody stools occur. Do not treat diarrhea without first checking with your doctor.


• Levofloxacin only works against bacteria; it does not treat viral infections (eg, the common cold).


• Be sure to use Levofloxacin for the full course of treatment. If you do not, the medicine may not clear up your infection completely. The bacteria could also become less sensitive to this or other medicines. This could make the infection harder to treat in the future.


• Long-term or repeated use of Levofloxacin may cause a second infection. Tell your doctor if signs of a second infection occur. Your medicine may need to be changed to treat this.


• Tell your doctor right away if you experience pain or swelling of a tendon or weakness or loss of use of a joint area. Rest the area and avoid exercise until further instruction from your doctor.


• Levofloxacin may cause you to become sunburned more easily. Avoid the sun, sunlamps, or tanning booths until you know how you react to Levofloxacin. Use a sunscreen or wear protective clothing if you must be outside for more than a short time.


• If you are scheduled to receive a typhoid vaccine while you are using Levofloxacin, talk with your doctor. Levofloxacin may decrease the effectiveness of the vaccine.


• Diabetes patients - Levofloxacin may affect your blood sugar. Check blood sugar levels closely. Ask your doctor before you change the dose of your diabetes medicine.


• Levofloxacin may interfere with certain lab tests. Be sure your doctor and lab personnel know you are using Levofloxacin.


• Lab tests, including liver and kidney function and complete blood cell counts, may be performed while you use Levofloxacin. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.


• Use Levofloxacin with caution in the ELDERLY; they may be more sensitive to its effects (eg, tendon problems), especially if they take corticosteroids (eg, prednisone). They may also be more sensitive to other effects (eg, irregular heartbeat, liver problems).


• Levofloxacin should be used with extreme caution in CHILDREN younger than 18 years; they may be more sensitive to its effects, especially joint and tendon problems.


• PREGNANCY and BREAST-FEEDING: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Levofloxacin while you are pregnant. Levofloxacin is found in breast milk. Do not breast-feed while using Levofloxacin.

Possible side effects of Levofloxacin:

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; diarrhea; dizziness; gas; headache; light-headedness; nausea; stomach pain.

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; unusual hoarseness); bloody or tarry stools; chest pain; decreased or painful urination; fainting; fast or irregular heartbeat; fever, chills, sore throat, or unusual cough; hallucinations; inability to move or bear weight on a joint or tendon area; moderate or severe sunburn; mood or mental changes (eg, new or worsening anxiety, nervousness, agitation, confusion, depression, restlessness, sleeplessness); muscle pain or weakness; new or worsening nightmares; pain, soreness, redness, swelling, weakness, or bruising of a tendon or joint area; red, swollen, blistered, or peeling skin; seizures; severe or persistent diarrhea; severe or persistent dizziness, light-headedness, tiredness, or weakness; severe or persistent stomach pain or cramps; shortness of breath or trouble breathing; suicidal thoughts or actions; symptoms of high or low blood sugar (eg, dizziness; fainting; fast breathing; flushing; increased thirst, hunger, or urination; increased sweating; vision changes); symptoms of liver problems (eg, dark urine, loss of appetite, pale stools, yellowing of the skin or eyes); symptoms of nerve problems (eg, changes in perception of heat or cold; decreased sensation of touch; unusual burning, numbness, tingling, pain, or weakness of the arms, hands, legs, or feet); tremors; unusual bruising or bleeding; vaginal discharge, irritation, or odor; vision changes; wheezing.

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.

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.

Proper storage of Levofloxacin:

Levofloxacin is usually handled and stored by a health care provider. If you are using Levofloxacin at home, store Levofloxacin as directed by your pharmacist or health care provider. Keep Levofloxacin out of the reach of children and away from pets.

General information:

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


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


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


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

This information is a summary only. It does not contain all information about Levofloxacin. 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 Levofloxacin resources

• Levofloxacin Use in Pregnancy & Breastfeeding
• Drug Images
• Levofloxacin Drug Interactions
• Levofloxacin Support Group
• 157 Reviews for Levofloxacin - Add your own review/rating

• Levofloxacin Prescribing Information (FDA)


• Levofloxacin Professional Patient Advice (Wolters Kluwer)


• Levofloxacin Monograph (AHFS DI)


• levofloxacin Advanced Consumer (Micromedex) - Includes Dosage Information


• Levaquin Prescribing Information (FDA)


• Levaquin Consumer Overview

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Chlorpheniramine/Codeine/Pseudoephedrine Suspension

Pronunciation: klor-fen-IR-a-meen/KOE-deen/SOO-doe-e-FED-rin
Generic Name: Chlorpheniramine/Codeine/Pseudoephedrine
Brand Name: Zodryl DAC

Chlorpheniramine/Codeine/Pseudoephedrine Suspension is used for:

Relieving symptoms of sinus congestion, runny nose, sneezing, itchy nose or throat, itchy or watery eyes, and cough due to colds, upper respiratory infections, or allergies. Chlorpheniramine/Codeine/Pseudoephedrine Suspension may also be used for other conditions as determined by your doctor.

Chlorpheniramine/Codeine/Pseudoephedrine Suspension is a decongestant, antihistamine, and cough suppressant combination. The decongestant works by constricting blood vessels and reducing swelling in the nasal passages. The antihistamine works by blocking the action of histamine, which helps reduce symptoms such as watery eyes and sneezing. The cough suppressant works in the brain to help decrease the cough reflex to reduce a dry cough.

Do NOT use Chlorpheniramine/Codeine/Pseudoephedrine Suspension if:

• you are allergic to any ingredient in Chlorpheniramine/Codeine/Pseudoephedrine Suspension or any other codeine- or morphine-related medicine (eg, dihydrocodeine, oxycodone)


• you have severe high blood pressure, severe heart blood vessel disease, rapid heartbeat, severe heart problems, increased pressure in the brain, respiratory depression, stomach ulcer, or narrow-angle glaucoma


• you are unable to urinate or are having an asthma attack


• you take droxidopa, sodium oxybate (GHB) or you have taken furazolidone or a monoamine oxidase inhibitor (MAOI) (eg, phenelzine) within the last 14 days

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

Before using Chlorpheniramine/Codeine/Pseudoephedrine Suspension:

Some medical conditions may interact with Chlorpheniramine/Codeine/Pseudoephedrine Suspension. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

• if you are pregnant, planning to become pregnant, or are breast-feeding


• if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement


• if you have allergies to medicines, foods, or other substances


• if you have a history of adrenal gland problems (eg, adrenal gland tumor), heart problems (eg, cor pulmonale; fast, slow, or irregular heartbeat; heart disease), high or low blood pressure, liver problems, low blood volume, diabetes, blood vessel problems, stroke, glaucoma or increased pressure in the eye, or thyroid problems


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


• if you have severe drowsiness, recent head or brain injury, brain tumor or lesions, increased pressure in the brain, infection of the brain or nervous system, or a seizure disorder (eg, epilepsy)


• if you have a history of constipation, stomach problems (eg, ulcers), bowel problems (eg, chronic inflammation, ulceration of the bowel, or diarrhea due to antibiotic use); a blockage of your stomach, bladder, or intestines; trouble urinating; an enlarged prostate or other prostate problems; or if you have had recent stomach, bowel, or urinary surgery


• if you have a history of alcohol abuse, drug abuse, mental or mood problems (eg, depression), or suicidal thoughts or behavior, or if you are in poor health or are very overweight

Some MEDICINES MAY INTERACT with Chlorpheniramine/Codeine/Pseudoephedrine Suspension. Tell your health care provider if you are taking any other medicines, especially any of the following:

• Digoxin or droxidopa because the risk of irregular heartbeat or heart attack may be increased


• Furazolidone, linezolid, or MAOIs (eg, phenelzine), because severe high blood pressure and fever may occur


• Barbiturates (eg, phenobarbital), beta-blockers (eg, propranolol), cimetidine, HIV protease inhibitors (eg, ritonavir), muscle relaxants (eg, cyclobenzaprine), opioid analgesics (eg, hydrocodone), phenothiazines (eg, chlorpromazine), sodium oxybate (GHB), tricyclic antidepressants (eg, amitriptyline), or urinary alkalinizers (eg, sodium bicarbonate) because they may increase the risk of Chlorpheniramine/Codeine/Pseudoephedrine Suspension's side effects


• Anticholinergics (eg, scopolamine) because a serious bowel motility problem (paralytic ileus) may occur


• Quinidine or rifamycins (eg, rifampin) because they may decrease Chlorpheniramine/Codeine/Pseudoephedrine Suspension's effectiveness


• Naltrexone because it may decrease Chlorpheniramine/Codeine/Pseudoephedrine Suspension's effectiveness. Withdrawal symptoms may also occur in patients who are physically dependent on opioids. Do not take naltrexone until you have stopped taking Chlorpheniramine/Codeine/Pseudoephedrine Suspension for 7 to 10 days and you have had a negative naloxone challenge test


• Bromocriptine or hydantoins (eg, phenytoin) because the risk of their side effects may be increased by Chlorpheniramine/Codeine/Pseudoephedrine Suspension


• Guanadrel, guanethidine, mecamylamine, methyldopa, or reserpine because their effectiveness may be decreased by Chlorpheniramine/Codeine/Pseudoephedrine Suspension

This may not be a complete list of all interactions that may occur. Ask your health care provider if Chlorpheniramine/Codeine/Pseudoephedrine Suspension 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 Chlorpheniramine/Codeine/Pseudoephedrine Suspension:

Use Chlorpheniramine/Codeine/Pseudoephedrine Suspension as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• Take Chlorpheniramine/Codeine/Pseudoephedrine Suspension by mouth with or without food. If stomach upset occurs, take with food to reduce stomach irritation.


• Shake well before use.


• Take Chlorpheniramine/Codeine/Pseudoephedrine Suspension with a full glass of water (8 oz/240 mL).


• Drink plenty of water while taking Chlorpheniramine/Codeine/Pseudoephedrine Suspension.


• Use a measuring device marked for medicine dosing. Ask your pharmacist for help if you are unsure of how to measure your dose.


• If you miss a dose of Chlorpheniramine/Codeine/Pseudoephedrine Suspension and you are taking it regularly, take it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once.

Ask your health care provider any questions you may have about how to use Chlorpheniramine/Codeine/Pseudoephedrine Suspension.

Important safety information:

• Chlorpheniramine/Codeine/Pseudoephedrine Suspension may cause drowsiness, dizziness, or blurred vision. These effects may be worse if you take it with alcohol or certain medicines. Use Chlorpheniramine/Codeine/Pseudoephedrine Suspension with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.


• Chlorpheniramine/Codeine/Pseudoephedrine Suspension may cause dizziness, lightheadedness, or fainting; alcohol, hot weather, exercise, or fever may increase these effects. To prevent them, sit up or stand slowly, especially in the morning. Sit or lie down at the first sign of any of these effects.


• Do not drink alcohol or use medicines that may cause drowsiness (eg, muscle relaxers, sleep aids) while you are using Chlorpheniramine/Codeine/Pseudoephedrine Suspension; it may add to their effects. Ask your pharmacist if you have questions about which medicines may cause drowsiness.


• Do not take diet or appetite control medicines while you take Chlorpheniramine/Codeine/Pseudoephedrine Suspension without checking with your doctor.


• Before you start any new medicine, check the label to see if it has a decongestant, antihistamine, or cough suppressant in it too. If it does or if you are not sure, check with your doctor or pharmacist.


• Do not use Chlorpheniramine/Codeine/Pseudoephedrine Suspension for a cough with a lot of mucus. Do not use it for a long-term cough (eg, caused by asthma, emphysema, smoking). However, you may use it for these conditions if your doctor tells you to.


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


• If your symptoms do not get better within 5 to 7 days, if they get worse, or if they occur along with a fever, check with your doctor.


• Chlorpheniramine/Codeine/Pseudoephedrine Suspension may cause you to become sunburned more easily. Avoid the sun, sunlamps, or tanning booths until you know how you react to Chlorpheniramine/Codeine/Pseudoephedrine Suspension. Use a sunscreen or wear protective clothing if you must be outside for more than a short time.


• Chlorpheniramine/Codeine/Pseudoephedrine Suspension may interfere with skin allergy tests. If you are scheduled for a skin test, talk to your doctor. You may need to stop taking Chlorpheniramine/Codeine/Pseudoephedrine Suspension for a few days before the tests.


• Tell your doctor or dentist that you take Chlorpheniramine/Codeine/Pseudoephedrine Suspension before you receive any medical or dental care, emergency care, or surgery.


• Use Chlorpheniramine/Codeine/Pseudoephedrine Suspension with caution in the ELDERLY; they may be more sensitive to its effects, especially confusion, dizziness, drowsiness, low blood pressure, excitability, dry mouth, and trouble urinating.


• Caution is advised when using Chlorpheniramine/Codeine/Pseudoephedrine Suspension in CHILDREN; they may be more sensitive to its effects, especially excitability.


• Chlorpheniramine/Codeine/Pseudoephedrine Suspension should not be used in CHILDREN younger than 2 years old; safety and effectiveness in these children have not been confirmed. They may be at greater risk for severe and possibly fatal breathing problems.


• PREGNANCY and BREAST-FEEDING: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Chlorpheniramine/Codeine/Pseudoephedrine Suspension while you are pregnant. Chlorpheniramine/Codeine/Pseudoephedrine Suspension is found in breast milk. Do not breast-feed while taking Chlorpheniramine/Codeine/Pseudoephedrine Suspension.

When used for long periods of time or at high doses, Chlorpheniramine/Codeine/Pseudoephedrine Suspension may not work as well and may require higher doses to obtain the same effect as when originally taken. This is known as TOLERANCE. Talk with your doctor if Chlorpheniramine/Codeine/Pseudoephedrine Suspension stops working well. Do not take more than prescribed.

Some people who use Chlorpheniramine/Codeine/Pseudoephedrine Suspension for a long time may develop a need to continue taking it. People who take high doses are also at risk. This is known as DEPENDENCE or addiction.

If you suddenly stop taking Chlorpheniramine/Codeine/Pseudoephedrine Suspension, you may experience WITHDRAWAL symptoms including anxiety; diarrhea; fever, runny nose, or sneezing; goose bumps and abnormal skin sensations; nausea; vomiting; pain; rigid muscles; rapid heartbeat; seeing, hearing, or feeling things that are not there; shivering or tremors; sweating; and trouble sleeping.

Possible side effects of Chlorpheniramine/Codeine/Pseudoephedrine Suspension:

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; dizziness; drowsiness; dry mouth, nose, or throat; excitability; headache; loss of appetite; nausea; nervousness or anxiety; trouble sleeping; upset stomach; vomiting; weakness.

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

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); confusion; difficulty urinating or inability to urinate; fainting; fast, slow, or irregular heartbeat; fever, chills, or persistent sore throat; hallucinations; loss of coordination; mental or mood changes (eg, depression); persistent trouble sleeping; ringing in the ears; seizures; severe dizziness, lightheadedness, or headache; severe drowsiness; shallow breathing; tremor; uncontrolled muscle movements; unusual bruising or bleeding; unusual weakness or tiredness; vision changes or blurred vision.

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: Chlorpheniramine/Codeine/Pseudoephedrine side effects (in more detail)

If OVERDOSE is suspected:

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

Proper storage of Chlorpheniramine/Codeine/Pseudoephedrine Suspension:

Store Chlorpheniramine/Codeine/Pseudoephedrine Suspension at 77 degrees F (25 degrees C). Store away from heat, moisture, and light. Do not store in the bathroom. Keep Chlorpheniramine/Codeine/Pseudoephedrine Suspension out of the reach of children and away from pets.

General information:

• If you have any questions about Chlorpheniramine/Codeine/Pseudoephedrine Suspension, please talk with your doctor, pharmacist, or other health care provider.


• Chlorpheniramine/Codeine/Pseudoephedrine Suspension is to be used only by the patient for whom it is prescribed. Do not share it with other people.


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


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

This information is a summary only. It does not contain all information about Chlorpheniramine/Codeine/Pseudoephedrine Suspension. 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.

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Phenazopyridine Tablets

Dosage Form: tablet
PHENAZOPYRIDINE HYDROCHLORIDE TABLETS, USP

Rx Only

CAUTION: Federal law prohibits dispensing without prescription.

DESCRIPTION

Phenazopyridine Hydrochloride is light or dark red to dark violet, odorless, slightly bitter, crystalline powder. It has a specific local analgesic effect in the urinary tract, promptly relieving burning and pain. It has the following structural formula:

Phenazopyridine HCl tablets contain the following inactive ingredients: carnauba wax, croscarmellose sodium, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, povidone, pregelatinized starch.

CLINICAL PHARMACOLOGY

Phenazopyridine HCl is excreted in the urine where it exerts a topical analgesic effect on the mucosa of the urinary tract. This action helps to relieve pain, burning, urgency and frequency. The precise mechanism of action is not known.

The pharmacokinetic properties of Phenazopyridine HCl have not been determined. Phenazopyridine HCl is rapidly excreted by the kidneys, with as much as 66% of an oral dose being excreted unchanged in the urine.

INDICATIONS AND USAGE

Phenazopyridine HCl is indicated for the symptomatic relief of pain, burning, urgency, frequency, and other discomforts arising from irritation of the lower urinary tract mucosa caused by infection, trauma, surgery, endoscopic procedures, or the passage of sounds or catheters. The use of Phenazopyridine HCl for relief of symptoms should not delay definitive diagnosis and treatment of causative conditions. Because it provides only symptomatic relief, prompt appropriate treatment of the cause of pain must be instituted and Phenazopyridine HCl should be discontinued when symptoms are controlled.

The analgesic action may reduce or eliminate the need for systemic analgesics or narcotics. It is, however, compatible with antibacterial therapy and can help to relieve pain and discomfort during the interval before antibacterial therapy controls the infection. Treatment of a urinary tract infection with Phenazopyridine HCl should not exceed 2 days because there is a lack of evidence that the combined administration of Phenazopyridine HCl and an antibacterial provides greater benefit than administration of the antibacterial alone after 2 days. (See DOSAGE AND ADMINISTRATION section.)

CONTRAINDICATIONS

Phenazopyridine HCl should not be used in patients who have previously exhibited hypersensitivity to it. The use of Phenazopyridine HCl is contraindicated in patients with renal insufficiency.

ADVERSE REACTIONS

Headache, rash, pruritus and occasional gastrointestinal disturbance. An anaphylactoid-like reaction has been described. Methemoglobinemia, hemolytic anemia, renal and hepatic toxicity have been reported, usually at overdosage levels (see Overdosage Section).

PRECAUTIONS

General: A yellowish tinge of the skin or sclera may indicate accumulation due to impaired renal excretion and the need to discontinue therapy. The decline in renal function associated with advanced age should be kept in mind.

NOTE: Patients should be informed that Phenazopyridine HCl produces a reddish-orange discoloration of the urine and may stain fabric. Staining of contact lenses has been reported.

Laboratory Test Interaction: Due to its properties as an azo dye, Phenazopyridine HCl may interfere with urinalysis based on spectrometry or color reactions.

Carcinogenesis, Mutagenesis, Impairment of Fertility: Long-term administration of Phenazopyridine HCl has induced neoplasia in rats (large intestine) and mice (liver).

Although no association between Phenazopyridine HCl and human neoplasia has been reported, adequate epidemiological studies along these lines have not been conducted.

Pregnancy Category B: Reproduction studies have been performed in rats at doses up to

50 mg/kg/day and have revealed no evidence of impaired fertility or harm to the fetus due to Phenazopyridine HCl. There are, however, no adequate and well controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed.

Nursing mothers: No information is available on the appearance of Phenazopyridine HCl, or its metabolites in human milk.

DOSAGE AND ADMINISTRATION

100 mg Tablets: Average adult dosage is two tablets 3 times a day after meals.

200 mg Tablets: Average adult dosage is one tablet 3 times a day after meals.

When used concomitantly with an antibacterial agent for the treatment of a urinary tract infection, the administration of Phenazopyridine HCl should not exceed 2 days.

OVERDOSAGE

Exceeding the recommended dose in patients with good renal function or administering the usual dose to patients with impaired renal function (common in elderly patients) may lead to increased serum levels and toxic reactions. Methemoglobinemia generally follows a massive, acute overdose. Methylene blue, 1 to 2 mg/kg/body weight intravenously or ascorbic acid 100 to 200 mg given orally should cause prompt reduction of the methemoglobinemia and disappearance of the cyanosis which is an aid in diagnosis. Oxidative Heinz body hemolytic anemia may also occur, and “bite cells” (degmacytes) may be present in a chronic overdosage situation. Red blood cell G-6-PD deficiency may predispose to hemolysis. Renal and hepatic impairment and occasional failure, usually due to hypersensitivity, may also occur.

HOW SUPPLIED

100 mg Tablets: Supplied in bottles of 100 (NDC 65162-517-10) counts.

Appearance: Deep brown to maroon colored, round, film coated tablets debossed “AN” above “1” on one side and plain on the other.

200 mg Tablets: Supplied in bottles of 100 (NDC 65162-520-10) counts.

Appearance: Deep brown to maroon colored, round, film coated tablets debossed “AN” above “2” on one side and plain on the other.

DISPENSE contents with a child-resistant closure (as required) and in a tight container as defined in the USP.

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].

Manufactured by:

Amneal Pharmaceuticals

Paterson, NJ 07504

Distributed by:

Amneal Pharmaceuticals

Glasgow, KY 42141

Rev. 08-2010

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

PHENAZOPYRIDINE HYDROCHLORIDE  phenazopyridine  tablet

Product Information Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 65162-517 Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength PHENAZOPYRIDINE HYDROCHLORIDE (PHENAZOPYRIDINE) PHENAZOPYRIDINE HYDROCHLORIDE 100 mg

Inactive Ingredients Ingredient Name Strength CARNAUBA WAX   CROSCARMELLOSE SODIUM   HYPROMELLOSES   MAGNESIUM STEARATE   CELLULOSE, MICROCRYSTALLINE   POLYETHYLENE GLYCOL   POVIDONE   STARCH, CORN

Product Characteristics Color BROWN (MAROON) Score no score Shape ROUND Size 10mm Flavor Imprint Code AN;1 Contains

Packaging # NDC Package Description Multilevel Packaging 1 65162-517-10 100 TABLET In 1 BOTTLE None

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Unapproved drug other		02/01/2011

PHENAZOPYRIDINE HYDROCHLORIDE  phenazopyridine  tablet

Product Information Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 65162-520 Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength PHENAZOPYRIDINE HYDROCHLORIDE (PHENAZOPYRIDINE) PHENAZOPYRIDINE HYDROCHLORIDE 200 mg

Inactive Ingredients Ingredient Name Strength CARNAUBA WAX   CROSCARMELLOSE SODIUM   HYPROMELLOSES   MAGNESIUM STEARATE   CELLULOSE, MICROCRYSTALLINE   POLYETHYLENE GLYCOL   POVIDONE   STARCH, CORN

Product Characteristics Color BROWN (MAROON) Score no score Shape ROUND Size 10mm Flavor Imprint Code AN;2 Contains

Packaging # NDC Package Description Multilevel Packaging 1 65162-520-10 100 TABLET In 1 BOTTLE None

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Unapproved drug other		02/01/2011

Labeler - Amneal Pharmaceuticals (123797875)

Registrant - Amneal Pharmaceuticals (123797875)

Establishment
Name	Address	ID/FEI	Operations
Amneal Pharmaceuticals		791930568	ANALYSIS, LABEL, MANUFACTURE, PACK

Revised: 07/2011Amneal Pharmaceuticals

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Pro-Epanutin Concentrate for Infusion / Solution for Injection (Pfizer Limited)

1. Name Of The Medicinal Product

Pro-Epanutin 75 mg/ml, Concentrate for solution for infusion/Solution for injection

(Pro-Dilantin, PROAURANTIN, Cereneu)

2. Qualitative And Quantitative Composition

One ml of Pro-Epanutin contains 75 mg of fosphenytoin sodium (equivalent to 50 mg of phenytoin sodium) and referred to as 50 mg PE (see Section 4.2).

Each 10 ml vial contains 750 mg of fosphenytoin sodium (equivalent to 500 mg of phenytoin sodium) and referred to as 500 mg PE.

Each 2 ml vial contains 150 mg of fosphenytoin sodium (equivalent to 100 mg of phenytoin sodium) and referred to as 100 mg PE.

For a full list of excipients, see Section 6.1

3. Pharmaceutical Form

Concentrate for solution for infusion/Solution for injection.

Pro-Epanutin is a clear, colourless to pale yellow, sterile solution buffered with trometamol adjusted to pH 8.6 to 9.0 with hydrochloric acid.

4. Clinical Particulars

4.1 Therapeutic Indications

Pro-Epanutin is indicated:

• for the control of status epilepticus of the tonic-clonic (grand mal) type (see Section 4.2).

• for prevention and treatment of seizures occurring in connection with neurosurgery and/or head trauma.

• as substitute for oral phenytoin if oral administration is not possible and/or contra-indicated.

4.2 Posology And Method Of Administration

IMPORTANT NOTE: Throughout all Pro-Epanutin product labelling, the amount and concentration of fosphenytoin is always expressed in terms of phenytoin sodium equivalents (PE) to avoid the need to perform molecular weight-based adjustments when converting between fosphenytoin and phenytoin sodium doses. Pro-Epanutin should always be prescribed and dispensed in phenytoin sodium equivalent units (PE). Note, however, that fosphenytoin has important differences in administration from parenteral phenytoin sodium (see Section 4.4 Special Warnings and Precautions for Use).

Phenytoin sodium equivalents (PE):

1.5 mg of fosphenytoin is equivalent to 1 mg PE (phenytoin sodium equivalent)

Administration:

Pro-Epanutin may be administered by IV infusion or by IM injection. The intramuscular route should be considered when there is not an urgent need to control seizures. Pro-Epanutin should not be administered by IM route in emergency situations such as status epilepticus.

Products with particulate matter or discoloration should not be used.

Intravenous infusion:

For IV infusion, Pro-Epanutin should be diluted in 5% glucose or 0.9% sodium chloride solution. The concentration should range from 1.5 to 25 mg PE/mL.

Because of the risk of hypotension, the recommended rate of administration by IV infusion in routine clinical settings is 50-100 mg PE/minute. Even in an emergency, it should not exceed 150 mg PE/minute. The use of a device controlling the rate of infusion is recommended.

Please refer to tables 1 to 10 for examples of dosing, dilution and infusion time calculations.

Continuous monitoring of electrocardiogram, blood pressure and respiratory function for the duration of the infusion is essential. The patient should also be observed throughout the period where maximal plasma phenytoin concentrations occur. This is approximately 30 minutes after the end of the Pro-Epanutin infusions.

Cardiac resuscitative equipment should be available (see Section 4.4 Special Warnings and Precautions for Use).

Please refer to Tables 1-10 for examples of dosing, dilution, and infusion time calculations
Population	Indication	Dosing Table
Adults	Status epilepticus	Loading dose	Table 1
Status epilepticus	Maintenance dose	Table 2
Seizure treatment or prophylaxis	Loading dose	Table 3
Seizure treatment or prophylaxis	Maintenance dose	Table 4
Temporary substitution for oral phenytoin	Table 5
Children	Status epilepticus	Loading dose	Table 6
Status epilepticus	Maintenance dose	Table 7
Seizure treatment or prophylaxis	Loading dose	Table 8
Seizure treatment or prophylaxis	Maintenance dose	Table 9
Temporary substitution for oral phenytoin	Table 10

DOSAGE IN ADULTS

(For Dose reduction in the Elderly please see guidance towards the end of this section.)

Status Epilepticus

Intramuscular administration of Pro-Epanutin is contra-indicated in the treatment of status epilepticus.

Loading dose:

In order to obtain rapid seizure control in patients with continuous seizure activity, IV diazepam or lorazepam should be administered prior to administration of Pro-Epanutin.

The loading dose of Pro-Epanutin is 15 mg PE/kg administered as a single dose by IV infusion.

Recommended IV infusion rate for loading dose: 100 to 150mg PE/min (should not exceed 150 mg PE/minute even for emergency use). See Table 1 for infusion times.

If administration of Pro-Epanutin does not terminate seizures, the use of alternative anticonvulsants should be considered.

Table 1: displays dosing information for status epilepticus loading dose in adults.

TABLE 1 STATUS EPILEPTICUS LOADING DOSE (ADULTS)
Examples of IV loading doses of 15mg PE/kg, and recommendations for dilution (to 25mg PE/ml) and IV infusion times (at maximum rate of 150 mg PE/min) by body weight
Weight (Kg)	Dose (mg PE)	Volume of Pro-Epanutin (50mg PE/ml)	Volume (ml) of diluent (5% glucose or 0.9% sodium chloride) for final concentration of 25 mg PE/ml	Minimum Infusion Time (mins) to achieve the maximum recommended infusion rate of 150mg PE / minute
No. of 10 ml vials to open	Volume (ml) to draw up
100	1500	3	30	30	10
95	1425	3	28.5	28.5	9.5
90	1350	3	27	27	9
85	1275	3	25.5	25.5	8.5
80	1200	3	24	24	8
75	1125	3	22.5	22.5	7.5
70	1050	3	21	21	7
65	975	2	19.5	19.5	6.5
60	900	2	18	18	6
55	825	2	16.5	16.5	5.5
50	750	2	15	15	5
45	675	2	13.5	13.5	4 .5

Maintenance dose:

The recommended maintenance dose of Pro-Epanutin of 4 to 5 mg PE/kg/day may be given by IV infusion or by IM injection. The total daily dose may be given in one or two divided doses.

Recommended IV infusion rate for maintenance dose: 50 to 100 mg PE/minute. See Table 2 for infusion times.

Maintenance doses should be adjusted according to patient response and trough plasma phenytoin concentrations (see Therapeutic Drug Monitoring).

Transfer to maintenance therapy with oral phenytoin should be made when appropriate.

Table 2: displays dosing information for status epilepticus maintenance dose in adults.

TABLE 2 STATUS EPILEPTICUS MAINTENANCE DOSE (ADULTS)
Examples for maximum IV maintenance doses of 5mg PE/kg, recommendations for dilution* (to 25mg PE/ml or to 1.5mg PE/ml), and IV infusion times (at maximum rate of 100mg PE/minute) by body weight
Weight (Kg)	Dose (mg PE)	Volume of Pro-Epanutin (50mg PE/ml)	Volume (ml) of diluent* ( 5% glucose or 0.9% sodium chloride)	Minimum Infusion Time (mins) to achieve the maximum recommended infusion rate of 100mg PE / minute
No. of 10ml vials to open	Volume (ml) to draw up	for final concentration of 25 mg PE/ml	for final concentration of 1.5 mg PE/ml
100	500	1	10	10	323	5
90	450	1	9	9	291	4.5
80	400	1	8	8	259	4
70	350	1	7	7	226	3.5
60	300	1	6	6	194	3
50	250	1	5	5	162	2.5
*For IV infusion the final concentration should range between 1.5 and 25 mg PE/ml

Treatment or Prophylaxis of Seizures

Loading dose:

The loading dose of Pro-Epanutin is 10 to 15 mg PE/kg given as a single dose by IV infusion or by IM injection.

Recommended IV infusion rate for treatment or prophylaxis of seizures loading dose: 50 to 100 mg PE/minute (should not exceed 150 mg PE/minute). See Table 3 for infusion times.

Table 3 displays dosing information for seizure treatment or prophylaxis loading dose in adults

TABLE 3 TREATMENT OR PROPHYLAXIS OF SEIZURES LOADING DOSE (ADULTS)
Examples for IV loading doses of 10mg PE/kga, and recommendations for dilution* (to 25mg PE/ml or to 1.5mg PE/ml) and IV infusion times (at maximum rate of 100mg PE/minute) by body weight
Weight (Kg)	Dose (mg PE)	Volume of Pro-Epanutin (50mg PE/ml)	Volume (ml) of diluent* ( 5% glucose or 0.9% sodium chloride)	Minimum Infusion Time (mins) to achieve the maximum recommended infusion rate of 100mg PE / minute
No. of 10ml vials to open	Volume (ml) to draw up	for final concentration of 25 mg PE/ml	For final concentration of 1.5mg PE/ml
100	1000	2	20	20	647	10
90	900	2	18	18	582	9
80	800	2	16	16	517	8
70	700	2	14	14	453	7
60	600	2	12	12	388	6
50	500	1	10	10	323	5
*For IV infusion the final concentration should range between 1.5 and 25 mg PE/ml a Please refer to Table 1 for examples of calculations for loading doses of 15mg PE/kg

Maintenance dose:

The recommended maintenance dose of Pro-Epanutin of 4 to 5 mg PE/kg/day may be given by IV infusion or by IM injection. The total daily dose may be given in one or two divided doses.

Recommended IV infusion rate for maintenance dose: 50 to 100 mg PE/minute. See Table 4 for infusion times.

Maintenance doses should be adjusted according to patient response and trough plasma phenytoin concentrations (see Therapeutic Drug Monitoring).

Transfer to maintenance therapy with oral phenytoin should be made when appropriate.

Table 4 displays dosing information for seizure treatment or prophylaxis maintenance dose in adults.

TABLE 4 TREATMENT OR PROPHYLAXIS OF SEIZURES MAINTENANCE DOSE (ADULTS)
Examples for maximum IV maintenance doses of 5mg PE/kg, recommendations for dilution* (to 25mg PE/ml or to 1.5mg PE/ml), and IV infusion times (at maximum infusion rate of 100mg PE/minute) by body weight
Weight (Kg)	Dose (mg PE)	Volume of Pro-Epanutin (50mg PE/ml)	Volume (ml) of diluent* ( 5% glucose or 0.9% sodium chloride)	Minimum Infusion Time (mins) to achieve the maximum recommended infusion rate of 100mg PE / minute
No. of 10ml vials to open	Volume (ml) to draw up	for final concentration of 25 mg PE/ml	for final concentration of 1.5mg PE/ml
100	500	1	10	10	323	5
90	450	1	9	9	291	4.5
80	400	1	8	8	259	4
70	350	1	7	7	226	3.5
60	300	1	6	6	194	3
50	250	1	5	5	162	2.5
*For IV infusion the final concentration should range between 1.5 to 25 mg PE/ml

Temporary substitution of oral phenytoin therapy with Pro-Epanutin.

The same dose and dosing frequency as for oral phenytoin therapy should be used and can be administered by IV infusion or by IM injection.

Recommended IV infusion rate for temporary substitution dosing: 50 to 100 mg PE/minute. See Table 5 for infusion times.

Therapeutic drug monitoring may be useful whenever switching between products and/or routes of administration. Doses should be adjusted according to patient response and trough plasma phenytoin concentrations (see Therapeutic Drug Monitoring).

Fosphenytoin has not been evaluated systemically for more than 5 days.

Table 5 displays dosing information for the temporary substitution of oral phenytoin in adults.

TABLE 5 TEMPORARY SUBSTITUTION OF ORAL PHENYTOIN THERAPY (ADULTS)
Examples of equivalent doses and recommendations for dilution* (to 25mg PE/ml or to 1.5mg PE/ml), and IV infusion times (at maximum rate of 100mg PE/minute)
Dose (mg phenytoin sodium)	Dose (mg PE)	Volume of Pro-Epanutin (50mg PE/ml)	Volume (ml) of diluent* ( 5% glucose or 0.9% sodium chloride)	Minimum Infusion Time (mins) to achieve the maximum recommended infusion rate of 100mg PE / minute
No. of 10 ml vials to open	Volume (ml) to draw up	for final concentration of 25 mg PE/ml	for final concentration of 1.5mg PE/ml
500	500	1	10	10	323	5
450	450	1	9	9	291	4.5
400	400	1	8	8	259	4
350	350	1	7	7	226	3.5
300	300	1	6	6	194	3
250	250	1	5	5	162	2.5
*For IV infusion the final concentration should range between 1.5 to 25 mg PE/ml

DOSAGE IN CHILDREN

Pro-Epanutin may be administered to children (ages 5 and above) by IV infusion only, at the same mg PE/kg dose used for adults. The doses of Pro-Epanutin for children have been predicted from the known pharmacokinetics of Pro-Epanutin in adults and children aged 5 to 10 years and of parenteral phenytoin in adults and children.

Intramuscular administration in children is not recommended.

Status Epilepticus

Loading dose

In order to obtain rapid seizure control in patients with continuous seizure activity IV diazepam or lorazepam should be administered prior to administration of Pro-Epanutin.

The loading dose of Pro-Epanutin is 15 mg PE/kg administered as a single dose by IV infusion.

Recommended IV infusion rate loading dose: 2 to 3 mg PE/kg/min (should not exceed 3mg PE/kg/minute or 150mg PE/minute). See Table 6 for infusion times.

If administration of Pro-Epanutin does not terminate seizures, the use of alternative anticonvulsants should be considered.

Table 6 displays dosing information for status epilepticus loading dose in children.

TABLE 6 STATUS EPILEPTICUS LOADING DOSE (CHILDREN)