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Procainamide

Pronunciation: proe-KANE-a-mide
Generic Name: Procainamide
Brand Name: Generic only. No brands available.

Taking Procainamide for a prolonged period of time may lead to the development of antibodies in your blood that are sometimes associated with autoimmune diseases such as lupus. If you experience butterfly-shaped rash on the face, swollen or tender joints, unexplained fever, or severe or persistent tiredness, seizures, or mental or mood changes, contact your doctor.

Procainamide should only be used to treat life-threatening irregular heartbeat. It has been associated with an increased risk of death when used to treat non-life-threatening irregular heartbeat. Talk with your doctor for more information.

Procainamide may cause severe and sometimes fatal blood problems (eg, bone marrow suppression, low blood platelet or white blood cell levels, anemia). These side effects have occurred most often during the first 12 weeks of therapy. Lab tests, such as complete blood cell counts, may be performed weekly for the first 3 months of therapy and then periodically to monitor for these side effects. If you experience fever, chills, sore throat, mouth sores or irritation, or unusual bruising or bleeding, contact your doctor immediately. Your risk may be greater if you already have bone marrow or blood problems.

Procainamide is used for:

Treating certain abnormal heart rhythms.

Procainamide is an antiarrhythmic. It works by stabilizing the heart rhythm in conditions in which the heart is beating too fast or in an irregular rhythm (antiarrhythmic effect).

Do NOT use Procainamide if:

you are allergic to any ingredient in Procainamide

you have had a severe allergic reaction (eg, severe rash, hives, difficulty breathing, dizziness) to a local anesthetic (eg, procaine)

you have complete heart block, lupus, or certain severe abnormal heart rhythms (eg, torsades de pointes)

you are taking astemizole, cisapride, dofetilide, a phenothiazine (eg, chlorpromazine), a phosphodiesterase type 5 inhibitor (eg, sildenafil), terfenadine, or ziprasidone

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

Before using Procainamide:

Some medical conditions may interact with Procainamide. 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 liver or kidney disease; congestive heart failure, heart block, QT prolongation, or other heart problems; bone marrow problems; blood problems (eg, low blood platelet or white blood cell levels); myasthenia gravis; or digitalis (digoxin) toxicity

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

Antiarrhythmics (eg, amiodarone, quinidine), anticholinergics (eg, hyoscyamine), arsenic, astemizole, cisapride, dofetilide, droperidol, H₂ antagonists (eg, cimetidine), ketolide antibiotics (eg, telithromycin), macrolide antibiotics (eg, erythromycin), phenothiazines (eg, chlorpromazine), phosphodiesterase type 5 inhibitors (eg, sildenafil), pimozide, quinolone antibiotics (eg, ciprofloxacin), serotonin receptor antagonists (eg, dolasetron), terfenadine), trimethoprim, or ziprasidone because the risk of side effects, including irregular heartbeat, may be increased

Neuromuscular blockers (eg, succinylcholine) because actions or side effects may be increased by Procainamide

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

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

Procainamide is usually administered as an injection at your doctor's office, hospital, or clinic. If you are using Procainamide at home, carefully follow the injection procedures taught to you by your health care provider.

If Procainamide contains particles or is discolored, or if the vial is cracked or damaged in any way, do not use it.

Keep this product, as well as syringes and needles, out of the reach of children and away from pets. Do not reuse needles, syringes, or other materials. Dispose of properly after use. Ask your doctor or pharmacist to explain local regulations for proper disposal.

Take Procainamide regularly to receive the most benefit from it.

Continue to use Procainamide even if you feel well. Do not miss any doses.

If you miss a dose of Procainamide, take it as soon as possible. If it is almost time for our 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 Procainamide.

Important safety information:

Procainamide may cause dizziness or blurred vision. Do not drive, operate machinery, or do anything else that could be dangerous until you know how you react to Procainamide.

Drinking alcohol may decrease the effectiveness of Procainamide. Check with your doctor before drinking alcohol.

Do not exceed the recommended dose or use Procainamide for longer than prescribed without checking with your doctor.

Do not suddenly stop taking Procainamide without checking with your doctor.

Procainamide may reduce the number of clot-forming cells (platelets) in your blood. To prevent bleeding, avoid situations in which bruising or injury may occur. Report any unusual bleeding, bruising, blood in stools, or dark, tarry stools to your doctor.

Procainamide may lower your body's ability to fight infection. Prevent infection by avoiding contact with people with colds or other infections. Notify your doctor of any signs of infection, including fever, sore throat, rash, or chills.

Before you have any medical or dental treatments, emergency care, or surgery, tell the doctor or dentist that you are using Procainamide.

Procainamide may interfere with certain lab tests. Make sure your doctor and laboratory personnel know you are using Procainamide.

Some of these products contain sulfites, which can cause allergic reactions in certain individuals (eg, asthma patients). If you have previously had allergic reactions to sulfites, contact your pharmacist to determine if the product you are taking contains sulfites.

LAB TESTS, including heart function tests, complete blood cell counts, and serum ANA titers, may be performed to monitor your progress or to check for side effects. Be sure to keep all doctor and lab appointments.

Use Procainamide with caution in the ELDERLY because they may be more sensitive to its effects.

Use Procainamide with extreme caution in CHILDREN. Safety and effectiveness have not been confirmed.

PREGNANCY and BREAST-FEEDING: If you become pregnant, discuss with your doctor the benefits and risks of using Procainamide during pregnancy. Procainamide is excreted in breast milk. Do not breast-feed while you are taking Procainamide.

Possible side effects of Procainamide:

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:

Pain, swelling, or redness at the injection site.

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); butterfly-shaped rash on the face; chest pain; dark urine; depression; diarrhea; dizziness or lightheadedness; fainting; fast, slow, or irregular heartbeat; fever, chills, or sore throat; hallucinations; loss of appetite; mood or mental changes; mouth sores or irritation; muscle pain or weakness; nausea; pale stools; seizures; stomach pain; severe or persistent tiredness; shortness of breath; swollen or tender joints; unusual bruising or bleeding; unusual tiredness or weakness; vomiting; wheezing; yellowing of the skin or eyes.

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

See also: Procainamide 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 (http://www.aapcc.org ), or emergency room immediately. Symptoms may include dizziness; fast or irregular heartbeat; irregular or difficult breathing; severe drowsiness; tremor.

Proper storage of Procainamide:

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

General information:

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

Procainamide 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 Procainamide. 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

More Procainamide resources

Procainamide Side Effects (in more detail)
Procainamide Use in Pregnancy & Breastfeeding
Drug Images
Procainamide Drug Interactions
Procainamide Support Group
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Procainamide Prescribing Information (FDA)

procainamide injection Concise Consumer Information (Cerner Multum)

procainamide Intravenous Advanced Consumer (Micromedex) - Includes Dosage Information

Procainamide Hydrochloride Monograph (AHFS DI)

Procanbid Prescribing Information (FDA)

Pronestyl Prescribing Information (FDA)

Pronestyl-SR Prescribing Information (FDA)

Compare Procainamide with other medications

Arrhythmia

Potassium Chloride

Potassium

Chloride

Extended-release Tablets, USP

8 mEq and 10 mEq

Potassium Chloride Description

Potassium Chloride Extended-release Tablets, USP are a solid oral dosage form of Potassium Chloride. Each contains 600 mg or 750 mg of Potassium Chloride equivalent to 8 mEq or 10 mEq of potassium in a wax matrix tablet. This formulation is intended to provide an extended-release of potassium from the matrix to minimize the likelihood of producing high, localized concentrations of potassium within the gastrointestinal tract.

Potassium Chloride Extended-release Tablets are an electrolyte replenisher. The chemical name is Potassium Chloride, and the structural formula is KCl. Potassium Chloride, USP is a white, granular powder or colorless crystals. It is odorless and has a saline taste. Its solutions are neutral to litmus. It is freely soluble in water and insoluble in alcohol.

Inactive Ingredients

Hydrogenated vegetable oil, magnesium stearate, polyethylene glycol, polyvinyl alcohol, silicon dioxide, talc and titanium dioxide. Dark blue tablets also contain FD&C Blue No. 1 aluminum lake.

Potassium Chloride - Clinical Pharmacology

The potassium ion is the principal intracellular cation of most body tissues. Potassium ions participate in a number of essential physiological processes including the maintenance of intracellular tonicity, the transmission of nerve impulses, the contraction of cardiac, skeletal and smooth muscle and the maintenance of normal renal function.

The intracellular concentration of potassium is approximately 150 to 160 mEq per liter. The normal adult plasma concentration is 3.5 to 5 mEq per liter. An active ion transport system maintains this gradient across the plasma membrane.

Potassium is a normal dietary constituent and under steady state conditions the amount of potassium absorbed from the gastrointestinal tract is equal to the amount excreted in the urine. The usual dietary intake of potassium is 50 to 100 mEq per day.

Potassium depletion will occur whenever the rate of potassium loss through renal excretion and/or loss from the gastrointestinal tract exceeds the rate of potassium intake. Such depletion usually develops slowly as a consequence of prolonged therapy with oral diuretics, primary or secondary hyperaldosteronism, diabetic ketoacidosis, severe diarrhea, or inadequate replacement of potassium in patients on prolonged parenteral nutrition. Depletion can develop rapidly with severe diarrhea, especially if associated with vomiting. Potassium depletion due to these causes is usually accompanied by a concomitant loss of chloride and is manifested by hypokalemia and metabolic alkalosis. Potassium depletion may produce weakness, fatigue, disturbances of cardiac rhythm (primarily ectopic beats), prominent U-waves in the electrocardiogram and, in advanced cases, flaccid paralysis and/or impaired ability to concentrate urine.

If potassium depletion associated with metabolic alkalosis cannot be managed by correcting the fundamental cause of the deficiency, e.g., where the patient requires long term diuretic therapy, supplemental potassium in the form of high potassium food or Potassium Chloride may be able to restore normal potassium levels.

In rare circumstances (e.g., patients with renal tubular acidosis) potassium depletion may be associated with metabolic acidosis and hyperchloremia. In such patients potassium replacement should be accomplished with potassium salts other than the chloride, such as potassium bicarbonate, potassium citrate, potassium acetate or potassium gluconate.

The Potassium Chloride in Potassium Chloride Extended-release Tablets is completely absorbed before it leaves the small intestine. The wax matrix is not absorbed and is excreted in the feces; in some instances the empty matrices may be noticeable in the stool. When the bioavailability of the potassium ion from the Potassium Chloride Extended-release Tablets is compared to that of a true solution the extent of absorption is similar.

The extended-release properties of Potassium Chloride Extended-release Tablets are demonstrated by the finding that a significant increase in time is required for renal excretion of the first 50% of the Potassium Chloride Extended-release Tablets dose as compared to the solution.

Increased urinary potassium excretion is first observed 1 hour after administration of Potassium Chloride Extended-release Tablets, reaches a peak at approximately 4 hours, and extends up to 8 hours. Mean daily steady-state plasma levels of potassium following daily administration of Potassium Chloride Extendedrelease Tablets cannot be distinguished from those following administration of Potassium Chloride solution or from control plasma levels of potassium ion.

Indications and Usage for Potassium Chloride

BECAUSE OF REPORTS OF INTESTINAL AND GASTRIC ULCERATION AND BLEEDING WITH EXTENDED-RELEASE Potassium Chloride PREPARATIONS, THESE DRUGS SHOULD BE RESERVED FOR THOSE PATIENTS WHO CANNOT TOLERATE OR REFUSE TO TAKE LIQUID OR EFFERVESCENT POTASSIUM PREPARATIONS OR FOR PATIENTS IN WHOM THERE IS A PROBLEM OF COMPLIANCE WITH THESE PREPARATIONS.

For the therapeutic use of patients with hypokalemia, with or without metabolic alkalosis; in digitalis intoxication; and in patients with hypokalemic familial periodic paralysis. If hypokalemia is the result of diuretic therapy, consideration should be given to the use of a lower dose of diuretic, which may be sufficient without leading to hypokalemia.

For the prevention of hypokalemia in patients who would be at particular risk if hypokalemia were to develop, e.g., digitalized patients or patients with significant cardiac arrhythmias.

The use of potassium salts in patients receiving diuretics for uncomplicated essential hypertension is often unnecessary when such patients have a normal dietary pattern and when low doses of the diuretic are used. Serum potassium should be checked periodically, however, and if hypokalemia occurs, dietary supplementation with potassium-containing foods may be adequate to control milder cases. In more severe cases, and if dose adjustment of the diuretic is ineffective or unwarranted, supplementation with potassium salts may be indicated.

Contraindications

Potassium supplements are contraindicated in patients with hyperkalemia since a further increase in serum potassium concentration in such patients can produce cardiac arrest. Hyperkalemia may complicate any of the following conditions: chronic renal failure, systemic acidosis such as diabetic acidosis, acute dehydration, extensive tissue breakdown as in severe burns, adrenal insufficiency or the administration of a potassiumsparing diuretic (e.g., spironolactone, triamterene or amiloride) ( see OVERDOSAGE).

Extended-release formulations of Potassium Chloride have produced esophageal ulceration in certain cardiac patients with esophageal compression due to an enlarged left atrium. Potassium supplementation, when indicated in such patients, should be given as a liquid preparation.

All solid oral dosage forms of Potassium Chloride are contraindicated in any patient in whom there is structural, pathological (e.g., diabetic gastroparesis) or pharmacologic (use of anticholinergic agents or other agents with anticholinergic properties at sufficient doses to exert anticholinergic effects) cause for arrest or delay in tablet passage through the gastrointestinal tract.

Warnings

Hyperkalemia

(see OVERDOSAGE)

In patients with impaired mechanisms for excreting potassium, the administration of potassium salts can produce hyperkalemia and cardiac arrest. This occurs most commonly in patients given potassium by the intravenous route but may also occur in patients given potassium orally. Potentially fatal hyperkalemia can develop rapidly and be asymptomatic.

The use of potassium salts in patients with chronic renal disease, or any other condition which impairs potassium excretion, requires particularly careful monitoring of the serum potassium concentration and appropriate dosage adjustment.

Interaction with Potassium-sparing Diuretics

Hypokalemia should not be treated by the concomitant administration of potassium salts and a potassium-sparing diuretic (e.g., spironolactone, triamterene or amiloride), since the simultaneous administration of these agents can produce severe hyperkalemia.

Interaction with Angiotensin Converting Enzyme Inhibitors

Angiotensin converting enzyme (ACE) inhibitors (e.g., captopril, enalapril) will produce some potassium retention by inhibiting aldosterone production. Potassium supplements should be given to patients receiving ACE inhibitors only with close monitoring.

Gastrointestinal Lesions

Solid oral dosage forms of Potassium Chloride can produce ulcerative and/or stenotic lesions of the gastrointestinal tract. Based on spontaneous adverse reaction reports, enteric-coated preparations of Potassium Chloride are associated with an increased frequency of small bowel lesions (40-50 per 100,000 patient years) compared to extended-release wax matrix formulations (less than one per 100,000 patient years). Because of the lack of extensive marketing experience with microencapsulated products, a comparison between such products and wax matrix or enteric-coated products is not available. Potassium Chloride Extended-release Tablets are wax matrix tablets formulated to provide an extended rate of release of Potassium Chloride and thus to minimize the possibility of high local concentration of potassium near the gastrointestinal wall.

Prospective trials have been conducted in normal human volunteers in which the upper gastrointestinal tract was evaluated by endoscopic inspection before and after one week of solid oral Potassium Chloride therapy. The ability of this model to predict events occurring in usual clinical practice is unknown. Trials which approximated usual clinical practice did not reveal any clear differences between the wax matrix and microencapsulated dosage forms. In contrast, there was a higher incidence of gastric and duodenal lesions in subjects receiving a high dose of a wax matrix extended-release formulation under conditions which did not resemble usual or recommended clinical practice (i.e., 96 mEq per day in divided doses of Potassium Chloride administered to fasted patients, in the presence of an anticholinergic drug to delay gastric emptying). The upper gastrointestinal lesions observed by endoscopy were asymptomatic and were not accompanied by evidence of bleeding (hemoccult testing). The relevance of these findings to the usual conditions (i.e., non-fasting, no anticholinergic agent, smaller doses) under which extended-release Potassium Chloride products are used is uncertain; epidemiologic studies have not identified an elevated risk, compared to microencapsulated products, for upper gastrointestinal lesions in patients receiving wax matrix formulations. Potassium Chloride Extendedrelease Tablets should be discontinued immediately and the possibility of ulceration, obstruction or perforation considered if severe vomiting, abdominal pain, distention or gastrointestinal bleeding occurs.

Metabolic Acidosis

Hypokalemia in patients with metabolic acidosis should be treated with an alkalinizing potassium salt such as potassium bicarbonate, potassium citrate, potassium acetate or potassium gluconate.

Precautions

General

The diagnosis of potassium depletion is ordinarily made by demonstrating hypokalemia in a patient with a clinical history suggesting some cause for potassium depletion. In interpreting the serum potassium level, the physician should be aware that acute alkalosis per se can produce hypokalemia in the absence of a deficit in total body potassium while acute acidosis per se can increase the serum potassium concentration into the normal range even in the presence of a reduced total body potassium. The treatment of potassium depletion, particularly in the presence of cardiac disease, renal disease or acidosis requires careful attention to acid-base balance and appropriate monitoring of serum electrolytes, the electrocardiogram and the clinical status of the patient.

Information for Patients

Physicians should consider reminding the patient of the following:

: To take each dose with meals and with a full glass of water or other liquid.
: To take this medicine following the frequency and amount prescribed by the physician. This is especially important if the patient is also taking diuretics and/or digitalis preparations.
: To check with the physician if there is trouble swallowing the tablets or if the tablets seem to stick in the throat.
: To check with the physician at once if tarry stools or other evidence of gastrointestinal bleeding is noticed.
: To take each dose without crushing, chewing or sucking the tablets.

Laboratory Tests

When blood is drawn for analysis of plasma potassium it is important to recognize that artifactual elevations can occur after improper venipuncture technique or as a result of in vitro hemolysis of the sample.

Drug Interactions

Potassium-sparing diuretic, angiotensin converting enzyme inhibitors (see WARNINGS).

Carcinogenesis, Mutagenesis, Impairment of Fertility

Carcinogenicity, mutagenicity and fertility studies in animals have not been performed. Potassium is a normal dietary constituent.

Pregnancy

Pregnancy Category C

Animal reproduction studies have not been conducted with Potassium Chloride Extended-release Tablets. It is unlikely that potassium supplementation that does not lead to hyperkalemia would have an adverse effect on the fetus or would affect reproductive capacity.

Nursing Mothers

The normal potassium ion content of human milk is about 13 mEq per liter. It is not known if Potassium Chloride Extended-release Tablets have an effect on this content. Since oral potassium becomes part of the body potassium pool, so long as body potassium is not excessive, the contribution of Potassium Chloride supplementation should have little or no effect on the level in human milk.

Pediatric Use

Safety and effectiveness in the pediatric population have not been established.

Geriatric Use

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

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

Adverse Reactions

One of the most severe adverse effects is hyperkalemia (see CONTRAINDICATIONS, WARNINGS and OVERDOSAGE). There also have been reports of upper and lower gastrointestinal conditions including obstruction, bleeding, ulceration and perforation (see CONTRAINDICATIONS and WARNINGS).

The most common adverse reactions to oral potassium salts are nausea, vomiting, flatulence, abdominal pain/discomfort and diarrhea. These symptoms are due to irritation of the gastrointestinal tract and are best managed by taking the dose with meals or reducing the amount taken at one time.

Skin rash has been reported rarely.

Overdosage

The administration of oral potassium salts to persons with normal excretory mechanisms for potassium rarely causes serious hyperkalemia. However, if excretory mechanisms are impaired, or if potassium is administered too rapidly intravenously, potentially fatal hyperkalemia can result (see CONTRAINDICATIONS and WARNINGS). It is important to recognize that hyperkalemia is usually asymptomatic and may be manifested only by an increased serum potassium concentration (6.5-8.0 mEq/L) and characteristic electrocardiographic changes (peaking of T-waves, loss of P-wave, depression of S-T segment and prolongation of the QT interval). Late manifestations include muscle paralysis and cardiovascular collapse from cardiac arrest (9-12 mEq/L).

Treatment measures for hyperkalemia include the following:

Elimination of foods and medications containing potassium and of any agents with potassium-sparing properties.

Intravenous administration of 300 to 500 mL/hr of 10% dextrose solution containing 10-20 units of crystalline insulin per 1,000 mL.

Correction of acidosis, if present, with intravenous sodium bicarbonate.

Use of exchange resins, hemodialysis or peritoneal dialysis.

In treating hyperkalemia, it should be recalled that in patients who have been stabilized on digitalis, too rapid a lowering of the serum potassium concentration can produce digitalis toxicity.

The extended release feature means that absorption and toxic effects may be delayed for hours. Consider standard measures to remove any unabsorbed drug.

Potassium Chloride Dosage and Administration

The usual dietary potassium intake by the average adult is 50 to 100 mEq per day. Potassium depletion sufficient to cause hypokalemia usually requires the loss of 200 mEq or more of potassium from the total body store.

Dosage must be adjusted to the individual needs of each patient. The dose for the prevention of hypokalemia is typically in the range of 20 mEq per day. Doses of 40-100 mEq per day or more are used for the treatment of potassium depletion. Dosage should be divided if more than 20 mEq per day is given such that no more than 20 mEq is given in a single dose.

Each Potassium Chloride Extended-release Tablet provides 8 mEq or 10 mEq of Potassium Chloride.

Potassium Chloride Extended-release Tablets should be taken with meals and with a glass of water or other liquid. This product should not be taken on an empty stomach because of its potential for gastric irritation (see WARNINGS).

NOTE: Potassium Chloride Extended-release Tablets must be swallowed whole and never crushed, chewed or sucked.

How is Potassium Chloride Supplied

Film-coated Potassium Chloride 8 mEq (dark-blue, debossed with "USL 8"), Potassium Chloride 10 mEq (white, debossed with "USL 10"), round tablets containing:

: 600 mg Potassium Chloride (equivalent to 8 mEq) in bottles of 100 (NDC 0781-1516-01), 500 (NDC 0781-1516-05) and 1,000 (NDC 0781-1516-10).
: 750 mg Potassium Chloride (equivalent to 10 mEq) in bottles of 100 (NDC 0781-1526-01), 500 (NDC 0781-1526-05) and 1,000 (NDC 0781-1526-10).

Store at controlled room temperature, 15-30°C (59-86°F). Protect from light and moisture. Dispense in a tight container with child-resistant closure.

Manufactured by

UPSHER-SMITH LABORATORIES, INC.

Minneapolis, MN 55447

for

Sandoz Inc.

Princeton, NJ 08540

Revised 0809

PRINCIPAL DISPLAY PANEL - 600 mg Tablet Bottle Label

NDC 0781-1516-01

Potassium Chloride

Extended-Release

Tablets, USP

8 mEq (600 mg)

Rx only

100 Tablets

SANDOZ

PRINCIPAL DISPLAY PANEL - 750 mg Tablet Bottle Label

NDC 0781-1526-01

Potassium Chloride

Extended-Release

Tablets, USP

10 mEq (750 mg)

Rx only

100 Tablets

SANDOZ

Potassium Chloride
Potassium Chloride tablet, film coated, extended release

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	NDC Product Code (Source)	0781-1516
Route of Administration	ORAL	DEA Schedule

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Potassium Chloride (Potassium Cation)	Potassium Chloride	600 mg

Inactive Ingredients
Ingredient Name	Strength
hydrogenated cottonseed oil
magnesium stearate
polyethylene glycols
polyvinyl alcohol
silicon dioxide
talc
titanium dioxide
FD&C BLUE NO. 1

Product Characteristics
Color	BLUE (dark blue)	Score	no score
Shape	ROUND	Size	11mm
Flavor		Imprint Code	USL;8
Contains

Packaging
#	NDC	Package Description	Multilevel Packaging
1	0781-1516-01	100 TABLET In 1 BOTTLE	None
2	0781-1516-05	500 TABLET In 1 BOTTLE	None
3	0781-1516-10	1000 TABLET In 1 BOTTLE	None

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
NDA	NDA019123	04/17/1986

Potassium Chloride
Potassium Chloride tablet, film coated, extended release

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	NDC Product Code (Source)	0781-1526
Route of Administration	ORAL	DEA Schedule

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Potassium Chloride (Potassium Cation)	Potassium Chloride	750 mg

Inactive Ingredients
Ingredient Name	Strength
hydrogenated cottonseed oil
magnesium stearate
polyethylene glycols
polyvinyl alcohol
silicon dioxide
talc
titanium dioxide

Product Characteristics
Color	WHITE	Score	no score
Shape	ROUND	Size	13mm
Flavor		Imprint Code	USL;10
Contains

Packaging
#	NDC	Package Description	Multilevel Packaging
1	0781-1526-01	100 TABLET In 1 BOTTLE	None
2	0781-1526-05	500 TABLET In 1 BOTTLE	None
3	0781-1526-10	1000 TABLET In 1 BOTTLE	None

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
NDA	NDA019123	04/17/1986

Labeler - Sandoz Inc. (110342024)

Registrant - Upsher-Smith Laboratories, Inc. (047251004)

Establishment
Name	Address	ID/FEI	Operations
Upsher-Smith Laboratories, Inc.		047251004	ANALYSIS

Establishment
Name	Address	ID/FEI	Operations
Upsher-Smith Laboratories, Inc.		618927206	MANUFACTURE

Establishment
Name	Address	ID/FEI	Operations
Sandoz Inc.		110342024	MANUFACTURE

Revised: 01/2012Sandoz Inc.

Protopam Chloride

Generic Name: pralidoxime (PRAL i DOX eem)

Brand Names: Protopam Chloride

What is Protopam Chloride (pralidoxime)?

Pralidoxime reverses muscle weakness or paralysis caused by a poison or certain drug overdose.

Pralidoxime is used as an antidote to treat poisoning by a chemical or pesticide (insect spray), or by a drug used to treat a muscle disorder.

This medication is not effective as an antidote for all types of pesticide poisonings.

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

What is the most important information I should know about Protopam Chloride (pralidoxime)?

If possible, before you receive pralidoxime, tell your doctor if you have kidney disease, or if you are allergic to any drugs. Also tell your doctor if you are pregnant or breast-feeding. In an emergency situation it may not be possible before you are treated to tell your caregivers about your health conditions or if you are pregnant or breast-feeding. Make sure any doctor caring for you afterward knows that you have received this medication.

What should I discuss with my health care provider before receiving Protopam Chloride (pralidoxime)?

If possible, before you receive pralidoxime, tell your doctor if you have kidney disease, or if you are allergic to any drugs. FDA pregnancy category C. It is not known whether pralidoxime is harmful to an unborn baby. Tell your doctor if you are pregnant. It is not known whether pralidoxime passes into breast milk or if it could harm a nursing baby.

In an emergency situation, it may not be possible before you are treated with pralidoxime to tell your caregivers if you are pregnant or breast-feeding. However, make sure any doctor caring for your pregnancy or your baby knows that you have received this medication.

How is pralidoxime given?

Pralidoxime is usually given as soon as possible after the onset of poisoning or overdose symptoms. You may need to receive pralidoxime for several days.

Pralidoxime is injected into a muscle, under the skin, or into a vein through an IV. A healthcare provider will give you this injection. Pralidoxime must be given slowly. The IV infusion can take up to 30 minutes to complete.

Your breathing, blood pressure, oxygen levels, kidney function, and other vital signs will be watched closely while you are receiving this medication.

After treatment with pralidoxime, you may be watched for up to 72 hours to make sure the medicine has been effective and you no longer have any effects of the poison or drug overdose.

What happens if I miss a dose?

Since pralidoxime is given by a healthcare professional in an emergency setting, you are not likely to miss a dose.

What happens if I overdose?

Since this medication is given by a healthcare professional in a medical setting, an overdose is unlikely to occur.

Overdose symptoms may include some of the side effects listed in this medication guide.

What should I avoid after receiving Protopam Chloride (pralidoxime)?

Follow your doctor's instructions about any restrictions on food, beverages, or activity.

Protopam Chloride (pralidoxime) side effects

Some of the side effects of pralidoxime may be similar to the symptoms of poisoning. Your caregivers will watch you closely to determine whether your body is responding well to the medication, or if you are having any serious side effects.

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat. Tell your caregivers at once if you have a serious side effect such as:

fast heart rate;

rapid breathing;

increased muscle stiffness;

a choking feeling;

Less serious side effects may include:

pain where the medicine was injected;

blurred vision;

feeling dizzy or drowsy;

headache; or

nausea.

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

What other drugs will affect Protopam Chloride (pralidoxime)?

If possible, before you receive this medication, tell your doctor about all other medicines you use, especially:

aminophylline (Phyllocontin, Truphylline);

atropine (Atreza, Sal-Tropine, and others);

morphine (Avinza, Kadian, MS Contin, Oramorph);

reserpine;

theophylline (Elixophyllin, Theo-24, Uniphyl);

a barbiturate such as butabarbital (Butisol), secobarbital (Seconal), pentobarbital (Nembutal), or phenobarbital (Solfoton); or

a tranquilizer such as chlorpromazine (Thorazine), fluphenazine (Permitil), perphenazine (Trilafon), prochlorperazine (Compazine), thioridazine (Mellaril), or trifluperazine (Stelazine).

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

More Protopam Chloride resources

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

Protopam Chloride Advanced Consumer (Micromedex) - Includes Dosage Information

Pralidoxime Chloride Monograph (AHFS DI)

Compare Protopam Chloride with other medications

Anticholinesterase Overdose
Nerve Agent Poisoning
Organophosphate Poisoning

Where can I get more information?

Your doctor or pharmacist can provide more information about pralidoxime.

See also: Protopam Chloride side effects (in more detail)

Prenate DHA

Generic Name: prenatal multivitamins (PRE nay tal VYE ta mins)

Brand Names: Advance Care Plus, Bright Beginnings, Cavan Folate, Cavan One, Cavan-Heme OB, Cenogen Ultra, CitraNatal Rx, Co Natal FA, Complete Natal DHA, Complete-RF, CompleteNate, Concept OB, Docosavit, Dualvit OB, Duet, Edge OB, Elite OB 400, Femecal OB, Folbecal, Folcaps Care One, Folivan-OB, Foltabs, Gesticare, Icar Prenatal, Icare Prenatal Rx, Inatal Advance, Infanate DHA, Kolnatal DHA, Lactocal-F, Marnatal-F, Maternity, Maxinate, Mission Prenatal, Multi-Nate 30, Multinatal Plus, Nata 29 Prenatal, Natachew, Natafort, Natelle, Neevo, Nestabs, Nexa Select with DHA, Novanatal, NovaStart, O-Cal Prenatal, OB Complete, OB Natal One, Ob-20, Obtrex DHA, OptiNate, Paire OB Plus DHA, PNV Select, PNV-Total, PR Natal 400, Pre-H-Cal, Precare, PreferaOB, Premesis Rx, PrenaCare, PrenaFirst, PrenaPlus, Prenatabs OBN, Prenatabs Rx, Prenatal 1 Plus 1, Prenatal Elite, Prenatal Multivitamins, Prenatal Plus, Prenatal S, Prenatal-U, Prenate Advanced Formula, Prenate DHA, Prenate Elite, Prenavite FC, PreNexa, PreQue 10, Previte Rx, PrimaCare, Pruet DHA, RE OB Plus DHA, Renate, RightStep, Rovin-NV, Se-Care, Se-Natal One, Se-Plete DHA, Se-Tan DHA, Select-OB, Seton ET, Strongstart, Stuart Prenatal with Beta Carotene, Tandem OB, Taron-BC, Tri Rx, TriAdvance, TriCare, Trimesis Rx, Trinate, Triveen-PRx RNF, UltimateCare Advance, Ultra-Natal, Vemavite PRX 2, VeNatal FA, Verotin-BY, Verotin-GR, Vinacal OR, Vinatal Forte, Vinate Advanced (New Formula), Vinate AZ, Vinate Care, Vinate Good Start, Vinate II (New Formula), Vinate III, Vinate One, Vitafol-OB, VitaNatal OB plus DHA, Vitaphil, Vitaphil Aide, Vitaphil Plus DHA, Vitaspire, Viva DHA, Vol-Nate, Vol-Plus, Vol-Tab Rx, Vynatal F.A., Zatean-CH, Zatean-PN

What are Prenate DHA (prenatal multivitamins)?

There are many brands and forms of prenatal vitamin available and not all brands are listed on this leaflet.

Prenatal vitamins are a combination of many different vitamins that are normally found in foods and other natural sources.

Prenatal vitamins are used to provide the additional vitamins needed during pregnancy. Minerals may also be contained in prenatal multivitamins.

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

What is the most important information I should know about prenatal vitamins?

There are many brands and forms of prenatal vitamin available and not all brands are listed on this leaflet.

Never take more than the recommended dose of a multivitamin. Avoid taking any other multivitamin product within 2 hours before or after you take your prenatal vitamins. Taking similar vitamin products together at the same time can result in a vitamin overdose or serious side effects.

Many multivitamin products also contain minerals such as calcium, iron, magnesium, potassium, and zinc. Minerals (especially taken in large doses) can cause side effects such as tooth staining, increased urination, stomach bleeding, uneven heart rate, confusion, and muscle weakness or limp feeling. Read the label of any multivitamin product you take to make sure you are aware of what it contains.

Seek emergency medical attention if you think you have used too much of this medicine. An overdose of vitamins A, D, E, or K can cause serious or life-threatening side effects and can also harm your unborn baby. Certain minerals contained in a prenatal multivitamin may also cause serious overdose symptoms or harm to the baby if you take too much.

Overdose symptoms may include stomach pain, vomiting, diarrhea, constipation, loss of appetite, hair loss, peeling skin, tingly feeling in or around your mouth, changes in menstrual periods, weight loss, severe headache, muscle or joint pain, severe back pain, blood in your urine, pale skin, and easy bruising or bleeding.

Do not take this medication with milk, other dairy products, calcium supplements, or antacids that contain calcium. Calcium may make it harder for your body to absorb certain ingredients of the multivitamin.

What should I discuss with my healthcare provider before taking prenatal vitamins?

Many vitamins can cause serious or life-threatening side effects if taken in large doses. Do not take more of this medication than directed on the label or prescribed by your doctor.

Before taking prenatal vitamins, tell your doctor about all of your medical conditions.

You may need to continue taking prenatal vitamins if you breast-feed your baby. Ask your doctor about taking this medication while breast-feeding.

How should I take prenatal vitamins?

Use exactly as directed on the label, or as prescribed by your doctor. Do not use in larger or smaller amounts or for longer than recommended.

Never take more than the recommended dose of prenatal vitamins.

Take your prenatal vitamin with a full glass of water.

Swallow the regular tablet or capsule whole. Do not break, chew, crush, or open it.

The chewable tablet must be chewed or allowed to dissolve in your mouth before swallowing. You may also allow the chewable tablet to dissolve in drinking water, fruit juice, or infant formula (but not milk or other dairy products). Drink this mixture right away.

Use prenatal vitamins regularly to get the most benefit. Get your prescription refilled before you run out of medicine completely.

Store at room temperature away from moisture and heat. Keep prenatal vitamins in their original container. Storing vitamins in a glass container can ruin the medication.

What happens if I miss a dose?

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

What happens if I overdose?

What should I avoid while taking prenatal vitamins?

Avoid taking any other multivitamin product within 2 hours before or after you take your prenatal vitamins. Taking similar vitamin products together at the same time can result in a vitamin overdose or serious side effects.

Avoid the regular use of salt substitutes in your diet if your multivitamin contains potassium. If you are on a low-salt diet, ask your doctor before taking a vitamin or mineral supplement.

Prenatal vitamins side effects

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

When taken as directed, prenatal vitamins are not expected to cause serious side effects. Less serious side effects may include:

upset stomach;

headache; or

unusual or unpleasant taste in your mouth.

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

What other drugs will affect prenatal vitamins?

Vitamin and mineral supplements can interact with certain medications, or affect how medications work in your body. Before taking a prenatal vitamin, tell your doctor if you also use:

diuretics (water pills);

heart or blood pressure medications;

tretinoin (Vesanoid);

isotretinoin (Accutane, Amnesteen, Clavaris, Sotret);

trimethoprim and sulfamethoxazole (Cotrim, Bactrim, Gantanol, Gantrisin, Septra, TMP/SMX); or

an NSAID (non-steroidal anti-inflammatory drug) such as ibuprofen (Advil, Motrin), naproxen (Aleve, Naprosyn, Naprelan, Treximet), celecoxib (Celebrex), diclofenac (Cataflam, Voltaren), indomethacin (Indocin), meloxicam (Mobic), and others.

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

More Prenate DHA resources

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

Prenate DHA MedFacts Consumer Leaflet (Wolters Kluwer)

Cal-Nate MedFacts Consumer Leaflet (Wolters Kluwer)

CareNatal DHA MedFacts Consumer Leaflet (Wolters Kluwer)

CitraNatal 90 DHA MedFacts Consumer Leaflet (Wolters Kluwer)

CitraNatal Assure Prescribing Information (FDA)

CitraNatal Harmony Prescribing Information (FDA)

Concept DHA Prescribing Information (FDA)

Docosavit Prescribing Information (FDA)

Duet DHA with Ferrazone MedFacts Consumer Leaflet (Wolters Kluwer)

Folbecal MedFacts Consumer Leaflet (Wolters Kluwer)

Folcal DHA Prescribing Information (FDA)

Folcaps Care One Prescribing Information (FDA)

Gesticare DHA Prescribing Information (FDA)

Gesticare DHA MedFacts Consumer Leaflet (Wolters Kluwer)

Inatal Advance Prescribing Information (FDA)

Inatal Ultra Prescribing Information (FDA)

Multi-Nate DHA Prescribing Information (FDA)

Multi-Nate DHA Extra Prescribing Information (FDA)

MultiNatal Plus MedFacts Consumer Leaflet (Wolters Kluwer)

Natelle One Prescribing Information (FDA)

Neevo Caplets MedFacts Consumer Leaflet (Wolters Kluwer)

OB Complete 400 MedFacts Consumer Leaflet (Wolters Kluwer)

Paire OB Plus DHA Prescribing Information (FDA)

PreNexa MedFacts Consumer Leaflet (Wolters Kluwer)

PreNexa Prescribing Information (FDA)

PreferaOB Prescribing Information (FDA)

Prenatal Plus Prescribing Information (FDA)

Prenatal Plus Iron Prescribing Information (FDA)

Prenate Elite MedFacts Consumer Leaflet (Wolters Kluwer)

Prenate Elite Prescribing Information (FDA)

Prenate Elite tablets

Prenate Essential Prescribing Information (FDA)

PrimaCare Advantage MedFacts Consumer Leaflet (Wolters Kluwer)

PrimaCare ONE capsules

PrimaCare One MedFacts Consumer Leaflet (Wolters Kluwer)

Renate DHA Prescribing Information (FDA)

Se-Natal 19 Prescribing Information (FDA)

Se-Natal 19 Chewable Tablets MedFacts Consumer Leaflet (Wolters Kluwer)

Tandem DHA Prescribing Information (FDA)

Tandem OB Prescribing Information (FDA)

TriAdvance Prescribing Information (FDA)

Triveen-One MedFacts Consumer Leaflet (Wolters Kluwer)

Triveen-PRx RNF Prescribing Information (FDA)

UltimateCare ONE NF Prescribing Information (FDA)

Ultra NatalCare MedFacts Consumer Leaflet (Wolters Kluwer)

Vinate AZ Prescribing Information (FDA)

Vitafol-One MedFacts Consumer Leaflet (Wolters Kluwer)

Zatean-CH Prescribing Information (FDA)

Compare Prenate DHA with other medications

Vitamin/Mineral Supplementation during Pregnancy/Lactation

Where can I get more information?

Your pharmacist can provide more information about prenatal vitamins.

See also: Prenate DHA side effects (in more detail)

Phospha 250 Neutral Oral, Parenteral

Generic Name: phosphate supplement (Oral route, Parenteral route)

Commonly used brand name(s)

In the U.S.

Fleet Phospho-soda EZ-Prep

K-Phos Neutral

K-Phos Original

OsmoPrep

Phospha 250 Neutral

Phospho-Soda

Visicol

Available Dosage Forms:

Tablet

Tablet, Enteric Coated

Liquid

Uses For Phospha 250 Neutral

Phosphates are used as dietary supplements for patients who are unable to get enough phosphorus in their regular diet, usually because of certain illnesses or diseases. Phosphate is the drug form (salt) of phosphorus. Some phosphates are used to make the urine more acid, which helps treat certain urinary tract infections. Some phosphates are used to prevent the formation of calcium stones in the urinary tract.

Injectable phosphates are to be administered only by or under the supervision of your health care professional. Some of these oral preparations are available only with a prescription. Others are available without a prescription; however, your health care professional may have special instructions on the proper dose of this medicine for your medical condition. You should take phosphates only under the supervision of your health care professional.

Importance of Diet

For good health, it is important that you eat a balanced and varied diet. Follow carefully any diet program your health care professional may recommend. For your specific dietary vitamin and/or mineral needs, ask your health care professional for a list of appropriate foods. If you think that you are not getting enough vitamins and/or minerals in your diet, you may choose to take a dietary supplement.

The best dietary sources of phosphorus include dairy products, meat, poultry, fish, and cereal products.

The daily amount of phosphorus needed is defined in several different ways.

For U.S.—

Recommended Dietary Allowances (RDAs) are the amount of vitamins and minerals needed to provide for adequate nutrition in most healthy persons. RDAs for a given nutrient may vary depending on a person's age, sex, and physical condition (e.g., pregnancy).

Daily Values (DVs) are used on food and dietary supplement labels to indicate the percent of the recommended daily amount of each nutrient that a serving provides. DV replaces the previous designation of United States Recommended Daily Allowances (USRDAs).

For Canada—

Recommended Nutrient Intakes (RNIs) are used to determine the amounts of vitamins, minerals, and protein needed to provide adequate nutrition and lessen the risk of chronic disease.

Normal daily recommended intakes for phosphorus are generally defined as follows:

Persons	U.S. (mg)	Canada (mg)
Infants birth to 3 years of age	300–800	150–350
Children 4 to 6 years of age	800	400
Children 7 to 10 years of age	800	500–800
Adolescent and adult males	800–1200	700–1000
Adolescent and adult females	800–1200	800–850
Pregnant females	1200	1050
Breast-feeding females	1200	1050

Before Using Phospha 250 Neutral

If you are taking a dietary supplement without a prescription, carefully read and follow any precautions on the label. For these supplements, the following should be considered:

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

Problems in children have not been reported with intake of normal daily recommended amounts. However, use of enemas that contain phosphates in children has resulted in high blood levels of phosphorus.

Geriatric

Problems in older adults have not been reported with intake of normal daily recommended amounts.

Pregnancy

It is especially important that you are receiving enough vitamins and minerals when you become pregnant and that you continue to receive the right amount of vitamins and minerals throughout your pregnancy. The healthy growth and development of the fetus depend on a steady supply of nutrients from the mother. However, taking large amounts of a dietary supplement in pregnancy may be harmful to the mother and/or fetus and should be avoided.

Breast Feeding

It is especially important that you receive the right amount of vitamins and minerals so that your baby will also get the vitamins and minerals needed to grow properly. However, taking large amounts of a dietary supplement while breast-feeding may be harmful to the mother and/or baby and should be avoided.

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 any of these dietary supplements, 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 dietary supplements in this class with any of the following medicines is not recommended. Your doctor may decide not to treat you with dietary supplements in this class or change some of the other medicines you take.

Amantadine

Atropine

Belladonna

Belladonna Alkaloids

Benztropine

Biperiden

Cisapride

Clidinium

Darifenacin

Dicyclomine

Dronedarone

Eplerenone

Glycopyrrolate

Hyoscyamine

Mesoridazine

Methscopolamine

Oxybutynin

Pimozide

Procyclidine

Scopolamine

Solifenacin

Sparfloxacin

Thioridazine

Tolterodine

Trihexyphenidyl

Using dietary supplements 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.

Alacepril

Alfuzosin

Amiloride

Amiodarone

Amitriptyline

Amoxapine

Apomorphine

Arsenic Trioxide

Asenapine

Astemizole

Azithromycin

Benazepril

Canrenoate

Captopril

Chloroquine

Chlorpromazine

Cilazapril

Ciprofloxacin

Citalopram

Clarithromycin

Clomipramine

Clozapine

Crizotinib

Dasatinib

Delapril

Desipramine

Disopyramide

Dofetilide

Dolasetron

Droperidol

Enalaprilat

Enalapril Maleate

Erythromycin

Flecainide

Fluconazole

Fosinopril

Gatifloxacin

Gemifloxacin

Granisetron

Halofantrine

Haloperidol

Ibutilide

Iloperidone

Imidapril

Imipramine

Indomethacin

Lapatinib

Levofloxacin

Lisinopril

Lopinavir

Lumefantrine

Mefloquine

Methadone

Moexipril

Moxifloxacin

Nilotinib

Norfloxacin

Nortriptyline

Octreotide

Ofloxacin

Ondansetron

Paliperidone

Pazopanib

Pentopril

Perflutren Lipid Microsphere

Perindopril

Posaconazole

Procainamide

Prochlorperazine

Promethazine

Propafenone

Protriptyline

Quetiapine

Quinapril

Quinidine

Quinine

Ramipril

Ranolazine

Salmeterol

Saquinavir

Solifenacin

Sorafenib

Sotalol

Spirapril

Spironolactone

Sunitinib

Telavancin

Telithromycin

Temocapril

Terfenadine

Tetrabenazine

Toremifene

Trandolapril

Trazodone

Triamterene

Trifluoperazine

Trimipramine

Vandetanib

Vardenafil

Vemurafenib

Voriconazole

Ziprasidone

Zofenopril

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.

Proper Use of phosphate supplement

This section provides information on the proper use of a number of products that contain phosphate supplement. It may not be specific to Phospha 250 Neutral. Please read with care.

For patients taking the tablet form of this medicine:

Do not swallow the tablet. Before taking, dissolve the tablet in ¾ to 1 glass (6 to 8 ounces) of water. Let the tablet soak in water for 2 to 5 minutes and then stir until completely dissolved.

For patients using the capsule form of this medicine:

Do not swallow the capsule. Before taking, mix the contents of 1 capsule in one-third glass (about 2½ ounces) of water or juice or the contents of 2 capsules in two-thirds glass (about 5 ounces) of water and stir well until dissolved.

For patients using the powder form of this medicine:

Add the entire contents of 1 bottle (2¼ ounces) to enough warm water to make 1 gallon of solution or the contents of one packet to enough warm water to make 1/3 of a glass (about 2.5 ounces) of solution. Shake the container for 2 or 3 minutes or until all the powder is dissolved.

Do not dilute solution further.

This solution may be chilled to improve the flavor; do not allow it to freeze.

Discard unused solution after 60 days.

Take this medicine immediately after meals or with food to lessen possible stomach upset or laxative action.

To help prevent kidney stones, drink at least a full glass (8 ounces) of water every hour during waking hours, unless otherwise directed by your health care professional.

Take this medicine only as directed. Do not take more of it and do not take it more often than recommended on the label, unless otherwise directed by your health care professional.

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 potassium phosphates

For oral dosage form (solution):
- To replace phosphorus lost by the body or to make the urine more acid or to prevent the formation of kidney stones in the urinary tract:
  - Adults and teenagers—The equivalent of 228 milligrams (mg) of phosphorus (2 tablets) dissolved in six to eight ounces of water four times a day, with meals and at bedtime.
- To replace phosphorus lost by the body:
  - Children over 4 years of age—The equivalent of 228 mg of phosphorus (2 tablets) dissolved in six to eight ounces of water four times a day, with meals and at bedtime.
  - Children up to 4 years of age—The dose must be determined by your doctor.

For oral dosage forms (capsules or oral solution):
- To replace phosphorus lost by the body:
  - Adults, teenagers, and children over 4 years of age—The equivalent of 250 mg of phosphorus (contents of 1 capsule) dissolved in two and one-half ounces of water or juice four times a day, after meals and at bedtime.
  - Children up to 4 years of age—Dose must be determined by your doctor.

For oral dosage forms (powder for oral solution):
- To replace phosphorus lost by the body:
  - Adults, teenagers, and children over 4 years of age—The equivalent of 250 mg of phosphorus dissolved in two and one-half ounces of water four times a day, after meals and at bedtime.
  - Children up to 4 years of age—Dose must be determined by your doctor.

For potassium and sodium phosphates

For oral dosage form (solution):
- To replace phosphorus lost by the body or to make the urine more acid or to prevent the formation of kidney stones in the urinary tract:
  - Adults and teenagers—The equivalent of 250 milligrams (mg) of phosphorus dissolved in eight ounces of water four times a day, after meals and at bedtime.
- To replace phosphorus lost by the body:
  - Children over 4 years of age—The equivalent of 250 mg of phosphorus dissolved in eight ounces of water four times a day, after meals and at bedtime.
  - Children up to 4 years of age—Dose must be determined by your doctor.

For oral dosage forms (capsules or solution):
- To replace phosphorus lost by the body:
  - Adults, teenagers, and children over 4 years of age—The equivalent of 250 mg of phosphorus (the contents of 1 capsule) dissolved in two and one-half ounces of water or juice four times a day, after meals and at bedtime.
  - Children up to 4 years of age—Dose must be determined by your doctor.

For oral dosage forms (powder for solution):
- To replace phosphorus lost by the body:
  - Adults, teenagers, and children over 4 years of age—The equivalent of 250 mg of phosphorus dissolved in two and one-half ounces of water four times a day, after meals and at bedtime.
  - Children up to 4 years of age—Dose must be determined by your doctor.

For oral dosage forms (tablets for solution):
- To replace phosphorus lost by the body:
  - Adults, teenagers, and children over 4 years of age—The equivalent of 250 mg of phosphorus (1 tablet) dissolved in eight ounces of water four times a day.
  - Children up to 4 years of age—Dose must be determined by your doctor.

Missed Dose

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

Storage

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 Phospha 250 Neutral

Your health care professional should check your progress at regular visits to make sure that this medicine does not cause unwanted effects.

Do not take iron supplements within 1 to 2 hours of taking this medicine. To do so may keep the iron from working properly.

For patients taking potassium phosphate-containing medicines:

Check with your health care professional before starting any strenuous physical exercise, especially if you are out of condition and are taking other medication. Exercise and certain medicines may increase the amount of potassium in the blood.

For patients on a potassium-restricted diet:

This medicine may contain a large amount of potassium. If you have any questions about this, check with your health care professional.

Do not use salt substitutes and low-salt milk unless told to do so by your health care professional. They may contain potassium.

For patients on a sodium-restricted diet:

This medicine may contain a large amount of sodium. If you have any questions about this, check with your health care professional.

Phospha 250 Neutral 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 as soon as possible if any of the following side effects occur:

Less common or rare

Confusion

convulsions (seizures)

decrease in amount of urine or in frequency of urination

fast, slow, or irregular heartbeat

headache or dizziness

increased thirst

muscle cramps

numbness, tingling, pain, or weakness in hands or feet

numbness or tingling around lips

shortness of breath or troubled breathing

swelling of feet or lower legs

tremor

unexplained anxiety

unusual tiredness or weakness

weakness or heaviness of legs

weight gain

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:

Diarrhea

nausea or vomiting

stomach pain

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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Poly-Pred

prednisolone acetate, neomycin sulfate, polymyxin b sulfate

Dosage Form: ophthalmic suspension
Poly-Pred®

(prednisolone acetate, neomycin sulfate, polymyxin B

sulfate ophthalmic suspension, USP)

sterile

Poly-Pred Description

Poly-Pred® (prednisolone acetate, neomycin sulfate, polymyxin B sulfate ophthalmic suspension, USP) is a topical anti-inflammatory/anti-infective combination product for ophthalmic use with a pH of 5.0 - 7.0 and an osmolality of 260-340 mOsm/kg.

Structural Formulas:

Chemical Name:

Prednisolone acetate: 11β, 17, 21-Trihydroxypregna-1, 4-diene-3, 20-dione 21-acetate.

Neomycin sulfate is the sulfate salt of neomycin B and neomycin C which are produced by the growth of Streptomyces fradiae (Fam. Streptomycetaceae). It has a potency equivalent to not less than 600 micrograms per milligram of neomycin base, calculated on an anhydrous basis.

Polymyxin B sulfate is the sulfate salt of polymyxin B1 and polymyxin B2 which are produced by the growth of Bacillus polymyxa (Prazmowski) Migula(Fam. Bacillaceae). It has a potency of not less than 6,000 polymyxin B units per milligram, calculated on an anhydrous basis.

Contains: Actives: prednisolone acetate (microfine suspension) 0.5%, neomycin sulfate equivalent to 0.35% neomycin base, polymyxin B sulfate 10,000 units/mL. Inactives: polysorbate 80; polyvinyl alcohol; propylene glycol; purified water; sodium acetate; and thimerosal 0.001% (preservative). The pH range is 5.0 - 7.0.

Poly-Pred - Clinical Pharmacology

Corticosteroids suppress the inflammatory response to a variety of agents and they probably delay or slow healing. Since corticosteroids may inhibit the body's defense mechanism against infection, a concomitant antimicrobial drug may be used when this inhibition is considered to be clinically significant in a particular case.

The anti-infective components in Poly-Pred® ophthalmic suspension are included to provide action against specific organisms susceptible to them. Neomycin sulfate and polymyxin B sulfate are considered active against the following microorganisms: Staphylococcus aureus; Escherichia coli; Hemophilus influenzae; Klebsiella/ Enterobacter species; Neisseria species; and Pseudomonas aeruginosa.

When a decision to administer both a corticosteroid and an antimicrobial is made, the administration of such drugs in combination has the advantage of greater patient compliance and convenience, with the added assurance that the appropriate dosage of both drugs is administered. When both types of drugs are in the same formulation, compatibility of ingredients is assured and the correct volume of drug is delivered and retained.

The relative potency of corticosteroids depends on the molecular structure, concentration and release from the vehicle.

Indications and Usage for Poly-Pred

A steroid/anti-infective combination is indicated for steroid-responsive inflammatory ocular conditions for which a corticosteroid is indicated and where bacterial infection or a risk of bacterial ocular infection exists.

Ocular steroids are indicated in inflammatory conditions of the palpebral and bulbar conjunctiva, cornea, and anterior segment of the globe where the inherent risk of steroid use in certain infective conjunctivitides is accepted to obtain a diminution in edema and inflammation. They are also indicated in chronic anterior uveitis and corneal injury from chemical, radiation, or thermal burns or penetration of foreign bodies.

The use of a combination drug with an anti-infective component is indicated where the risk of infection is high or where there is an expectation that potentially dangerous numbers of bacteria will be present in the eye.

The particular anti-infective drugs in this product are active against the following common bacterial eye pathogens: Staphylococcus aureus; Escherichia coli; Hemophilus influenzae; Klebsiella/ Enterobacter species; Neisseria species; and Pseudomonas aeruginosa.

The product does not provide adequate coverage against: Serratia marcescens; Streptococci, including Streptococcus pneumoniae.

Contraindications

Epithelial herpes simplex keratitis (dendritic keratitis), vaccinia, varicella, and many other viral diseases of the cornea and conjunctiva. Mycobacterial infection of the eye. Fungal diseases of the ocular structures. Hypersensitivity to a component of the medication. (Hypersensitivity to the antibiotic component occurs at a higher rate than for other components.)

The use of these combinations is always contraindicated after uncomplicated removal of a corneal foreign body.

Warnings

NOT FOR INJECTION INTO THE EYE.

Prolonged use may result in glaucoma, with damage to the optic nerve, defects in visual acuity and fields of vision, and in posterior subcapsular cataract formation. Prolonged use may suppress the host response and thus increase the hazard of secondary ocular infections. In those diseases causing thinning of the cornea or sclera, perforations have been known to occur with the use of topical steroids. In acute purulent conditions of the eye, steroids may mask infection or enhance existing infection. If these products are used for 10 days or longer, intraocular pressure should be routinely monitored even though it may be difficult in children and uncooperative patients.

Employment of a steroid medication in the treatment of herpes simplex requires great caution.

There exists a potential for neomycin sulfate to cause cutaneous sensitization. The exact incidence of this reaction is unknown. The manifestations of sensitization to topical antibiotics are usually itching, reddening, and edema of the conjunctiva and eyelid. A sensitization reaction may manifest simply as a failure to heal. During long-term use of topical antibiotic products, periodic examination for such signs is advisable, and the patient should be told to discontinue the product if they are observed. Symptoms usually subside quickly on withdrawing the medication. Application of products containing these ingredients should be avoided for the patient thereafter (see PRECAUTIONS: General).

Precautions

General:

The initial prescription and renewal of the medication order beyond 20 milliliters should be made by a physician only after examination of the patient with the aid of magnification, such as slit lamp biomicroscopy and, where appropriate, fluorescein staining.

The possibility of persistent fungal infections of the cornea should be considered after prolonged steroid dosing.

As with other antimicrobial preparations, prolonged use may result in overgrowth of nonsusceptible organisms, including fungi. If superinfection occurs, appropriate therapy should be initiated.

Bacterial resistance to Poly-Pred® ophthalmic suspension may also develop. If purulent discharge, inflammation, or pain becomes aggravated, the patient should discontinue use of the medicatioin and consult a physician.

Allergic cross-reactions may occur which could prevent the use of any or all of the following antibiotics for the treatment of future infections: kanamycin, paromomycin, streptomycin, and possibly gentamicin.

Information for Patients:

If inflammation or pain persists longer than 48 hours or becomes aggravated, the patient should be advised to discontinue use of the medication and consult a physician (See WARNINGS).

This product is sterile when packaged. To prevent contamination, care should be taken to avoid touching the applicator tip to eyelids or to any other surface. The use of this bottle by more than one person may spread infection. Keep bottle tightly closed when not in use. Keep out of the reach of children.

Patients should be advised not to wear contact lenses if they have signs and symptoms of ocular bacterial infections.

Carcinogenesis, Mutagenesis, Impairment of Fertility:

No studies have been conducted in animals or in humans to evaluate the potential of these effects due to prednisolone.

Treatment of human lymphocytes in-vitro with neomycin increased the frequency of chromosome aberrations at the highest concentration (80 μg/mL) tested; however, the effects of neomycin on carcinogenesis and mutagenesis in humans are unknown.

No studies have been conducted with polymyxin B sulfate to evaluate carcinogenic or mutagenic potential. Polymyxin B has been reported to impair the motility of equine sperm, but its effects on male or female fertility are unknown.

Pregnany: Teratogenic Effects:

Pregnancy Category C. Prednisolone has been shown to be teratogenic in rabbits, hamsters, and mice. In mice, prednisolone has been shown to be teratogenic when given in doses 1 to 10 times the human ocular dose. Dexamethasone, hydrocortisone and prednisolone were applied to both eyes of pregnant mice five times per day on days 10 through 13 of gestation. A significant increase in the incidence of cleft palate was observed in the fetuses of the treated mice. There are no adequate well-controlled studies in pregnant women dosed with corticosteroids.

Animal reproduction studies have not been conducted with polymyxin B sulfate or neomycin sulfate. It is also not known whether polymyxin B sulfate or neomycin sulfate can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity.

Poly-Pred® ophthalmic suspension should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

Nursing Mothers:

This drug is excreted in human milk. Caution should be exercised when Poly-Pred® ophthalmic suspension is administered to a nursing woman.

Pediatric Use:

Safety and effectiveness in pediatric patients have not been established.

Geriatric Use:

No overall differences in safety or effectiveness have been observed between elderly and younger patients.

Adverse Reactions

Adverse reactions have occurred with steroid/anti-infective combination drugs which can be attributed to the steroid component, the anti-infective component, or the combination. Exact incidence figures are not available since no denominator of treated patients is available.

Reactions occurring most often from the presence of the anti-infective ingredients are allergic sensitizations including itching, swelling, and conjunctival erythema (see WARNINGS). More serious hypersensitivity reactions, including anaphylaxis, have been reported rarely. The reactions due to the steroid component in decreasing order of frequency are: elevation of intraocular pressure (IOP) with possible development of glaucoma, and infrequent optic nerve damage; posterior subcapsular cataract formation; and delayed wound healing.

Although systemic effects are extremely uncommon, there have been rare occurences of systemic hypercorticoidism after use of topical steroids.

Corticosteroid-containing preparations have also been reported to cause perforation of the globe. Keratitis, conjunctivitis, corneal ulcers, and conjunctival hyperemia have occasionally been reported following local use of steroids.

Secondary infection: The development of secondary infection has occurred after use of combinations containing steroids and antimicrobials. Fungal infections of the cornea are particularly prone to develop coincidentally with long-term applications of steroids. The possibility of fungal invasion must be considered in any persistent corneal ulceration where steroid treatment has been used.

Secondary bacterial ocular infection following suppression of host responses also occurs.

Poly-Pred Dosage and Administration

TO TREAT THE EYE: Instill 1 or 2 drops every 3 or 4 hours, or more frequently as required. Acute infections may require administration every 30 minutes, with frequency of administration reduced as the infection is brought under control. TO TREAT THE LIDS: Instill 1 or 2 drops in the eye every 3 to 4 hours, close the eye and rub the excess on the lids and lid margins.

Not more than 20 milliliters should be prescribed initially and the prescription should not be refilled without further evaluation as outlined in the PRECAUTIONS section above.

How is Poly-Pred Supplied

Poly-Pred® (prednisolone acetate, neomycin sulfate, polymyxin B sulfate ophthalmic suspension, USP) is supplied sterile in opaque white LDPE plastic bottles with droppers with white high impact polystyrene (HIPS) caps as follows:

5 mL in 10 mL bottle – NDC 0023-0028-05

Note: Store at 15 - 25˚C (59 - 77˚F). Protect from freezing. Shake well before using. Store in an upright position.

Rx Only

Revised December 2004

Irvine, CA 92612, U.S.A.

® Marks owned by Allergan, Inc.

6399X

71746US10P

ALLERGAN

NDC 0023-0028-05

Rx Only

Poly-Pred®

(prednisolone

acetate, neomycin

sulfate, polymyxin

B sulfate

ophthalmic

suspension, USP)

sterile

5 mL

ALLERGAN

NDC 0023-0028-05 Rx Only

Poly-Pred®

(prednisolone acetate, neomycin

sulfate, polymyxin B sulfate

ophthalmic suspension, USP)

5 mL sterile

Poly-Pred
prednisolone acetate, neomycin sulfate, polymyxin b sulfate suspension/ drops

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	NDC Product Code (Source)	0023-0028
Route of Administration	OPHTHALMIC	DEA Schedule

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
prednisolone acetate (prednisolone)	prednisolone acetate	5 mg in 1 mL
neomycin sulfate (neomycin)	neomycin sulfate	3.5 mg in 1 mL
polymyxin B sulfate (polymyxin B)	polymyxin B sulfate	10000 [USP'U] in 1 mL

Inactive Ingredients
Ingredient Name	Strength
polysorbate 80
polyvinyl alcohol
propylene glycol
water
sodium acetate
thimerosal

Product Characteristics
Color		Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	NDC	Package Description	Multilevel Packaging
1	0023-0028-05	1 BOTTLE In 1 CARTON	contains a BOTTLE, DROPPER
1		5 mL In 1 BOTTLE, DROPPER	This package is contained within the CARTON (0023-0028-05)

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
NDA	NDA050081	12/15/1981

Labeler - Allergan, Inc. (144796497)

Establishment
Name	Address	ID/FEI	Operations
Allergan, Inc.		362898611	MANUFACTURE

Revised: 08/2011Allergan, Inc.

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Poly-Pred Side Effects (in more detail)
Poly-Pred Dosage
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