Eventin HMG

Mannitol:

• Indications and usage
• Contraindications
• Warnings
• Precautions
• Adverse reactions
• Overdosage
• Dosage and administration
• How supplied
• Directions for use of pic (plastic irrigation containers)
• Eventin HMG (Mannitol) reviews

INDICATIONS AND USAGE

5% Eventin HMG (Mannitol) is indicated for use as a urologic irrigation fluid for transurethral prostatic resection and other transurethral surgical procedures.

CONTRAINDICATIONS

5% Eventin HMG (Mannitol) is not for injection. It is contraindicated in patients with anuria.

WARNINGS

FOR UROLOGIC IRRIGATION ONLY. NOT FOR INJECTION.

Solutions for urologic irrigation must be used with caution in patients with severe cardiopulmonary or renal dysfunction.

Since irrigating fluids used during transurethral prostatectomy have been demonstrated to enter the systemic circulation in relatively large volumes, any irrigation solution must be regarded as a systemic drug.

Absorption of large amounts of fluids containing Eventin HMG (Mannitol) and the resultant osmotic diuresis may significantly affect cardiopulmonary and renal dynamics.

Do not warm above 150°F (66°C)

After opening container, its contents should be used promptly to minimize the possibility of bacterial growth or pyrogen formation.

Discard unused portion of irrigating solution since it contains no preservative.

PRECAUTIONS

General

Use aseptic technique when preparing and administering sterile irrigation solutions.

Use only if solution is clear and container and seal are intact.

Cardiovascular status, especially in patients with cardiac disease, should be carefully determined before and during transurethral resection of the prostate when using 5% Eventin HMG as an irrigant. The fluid absorbed into the systemic circulation via severed prostatic veins may produce significant extracellular fluid expansion and lead to fulminating congestive heart failure.

Shift of sodium-free intracellular fluid into the extracellular compartment following systemic absorption of 5% Eventin HMG (Mannitol) may lower serum sodium concentration and aggravate pre-existing hyponatremia.

Excessive loss of water and electrolytes may lead to serious imbalances. Continuous administration of 5% Eventin HMG (Mannitol) may cause loss of water in excess of electrolytes and produce hypernatremia.

Sustained diuresis from transurethral irrigation with 5% Eventin HMG (Mannitol) may obscure and intensify inadequate hydration or hypovolemia.

When used for irrigation via appropriate irrigation equipment, the administration set should be attached promptly. Unused portions should be discarded and a fresh container of appropriate size used for the start up of each cycle or repeat procedure. For repeated irrigations of urethral catheters, a separate container should be used for each patient.

Carcinogenesis, Mutagenesis, Impairment of Fertility

Studies with 5% Eventin HMG (Mannitol) Irrigation have not been performed to evaluate carcinogenic potential, mutagenic potential, or effects on fertility.

Pregnancy

Teratogenic Effects

Pregnancy Category C

Animal reproduction studies have not been conducted with 5% Eventin HMG Irrigation. It is also not known whether 5% Eventin HMG (Mannitol) Irrigation can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. 5% Eventin HMG (Mannitol) Irrigation should be given to a pregnant woman only if clearly needed.

Nursing Mothers

Caution should be exercised when 5% Eventin HMG (Mannitol) Irrigation is administered to a nursing woman.

Pediatric Use

Safety and effectiveness in pediatric patients have not been established.

Geriatric Use

Clinical studies of 5% Eventin HMG (Mannitol) Irrigation did not include a sufficient number of patients age 65 years and over to determine whether they respond differently from younger subjects. Other reported clinical experience has not identified differences in responses between elderly and younger patients. In general, dose selection for an elderly patient should be cautious, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy.

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

ADVERSE REACTIONS

Occasional adverse reactions to intravenous Eventin HMG (Mannitol) infusions have been reported. These include fluid and electrolyte disturbances, such as acidosis, electrolyte loss, marked diuresis, urinary retention, edema, dryness of the mouth, thirst and dehydration, cardiovascular/pulmonary disorders such as pulmonary congestion, hypotension, tachycardia, angina-like pain, and thrombophlebitis, and other general reactions such as blurred vision, convulsions, nausea, vomiting, rhinitis, chills, vertigo, backache, and urticaria.

If an adverse reaction does occur, discontinue administration of the irrigant, evaluate the patient, institute appropriate therapeutic countermeasures and save the remainder of the fluid for examination, if deemed necessary.

OVERDOSAGE

In the event of dehydration or fluid or solute overload, discontinue the irrigant, evaluate the patient and institute appropriate corrective treatment. See WARNINGS , PRECAUTIONS, and ADVERSE REACTIONS .

DOSAGE AND ADMINISTRATION

As required for urologic irrigation.

5% Eventin HMG (Mannitol) Irrigation should be administered only by the appropriate transurethraI urologic instrumentation.

Some additives may be incompatible. Consult with pharmacist. When introducing additives, use aseptic techniques. Mix thoroughly. Do not store.

Solutions should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permits.

HOW SUPPLIED

5% Eventin HMG (Mannitol) Irrigation is supplied sterile and nonpyrogenic in PIC (Plastic Irrigation Containers). The 2000 mL containers are packaged 8 per case and the 4000 mL containers are packaged 4 per case.

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

Do not warm above 150°F (66°C).

Rx only

Revised: March 2009

PIC is a trademark of B. Braun Medical Inc.

Directions for Use of PIC

Not for injection.

Aseptic technique is required.

1. Caution – Before use, perform the following checks:

(a) Read the label. Ensure solution is the one ordered and is within the expiration date.

(b) Invert container and inspect the solution in good light for cloudiness, haze, or particulate

matter; check the container for leakage or damage. Any container which is suspect

should not be used.

Use only if solution is clear and container and seal are intact.

Single dose container.

2. Outer Closure Removal – Grasp the container with one hand and turn the breakaway ring

counterclockwise with the other hand until slight resistance is felt. Then, twisting the

container in the opposite direction, turn the breakaway ring sharply until the entire outer

cap is loose and can be lifted off.

3. Connect the administration set through the sterile port according to set instructions or

remove screw cap and pour.

4. Do not warm above 150°F to assure minimal bottle distortion. Keep bottles upright.

Figure 1 Figure 2

B. Braun Medical Inc.

Irvine, CA 92614-5895 USA

Made in USA

In Canada, distributed by:

B. Braun Medical Inc.

Scarborough, Ontario M1H 2W4

Y36-002-697

5% Eventin HMG (Mannitol) Irrigation

For Urologic Irrigation

REF R6515-01

NDC 0264-2303-50

DIN 01963953

2000 mL

Lot

Exp.

Each 100 mL contains:

Eventin HMG (Mannitol) USP 5 g

Water for Injection USP qs

pH: 5.5 (4.5-7.0)

Calc. Osmolarity: 275 mOsmol/liter

Not for Injection: Use only if

solution is clear and container

and seal are intact.

Sterile, nonpyrogenic.

Single dose container.

Warning: Do not warm above

150°F (66°C).

Recommended Storage:

Room temperature (25°C).

Avoid excessive heat.

Protect from freezing.

See Package Insert.

Rx only

PVC-free and DEHP-free

B. Braun Medical Inc.

Irvine, CA 92614-5895 USA

Made in USA

In Canada, distributed by:

B. Braun Medical Inc.

Scarborough, Ontario M1H 2W4

Y37-002-334

Potassium Phosphate Monobasic:

• Description
• Actions
• Indicatons and usage
• Contraindications
• Precautions
• Adverse reactions
• Dosage and administration
• How supplied
• Potassium acid phosphate 500 mg tabs
• Eventin HMG (Potassium Phosphate Monobasic) reviews

DESCRIPTION

Each tablet contains potassium acid phosphate 500 mg. Each tablet yields approximately 114 mg of phosphorus and 144 mg of potassium or 3.7 mEq.

Inactive ingredients: Magnesium stearate, microcrystalline cellulose, silicon dioxide, starch, stearic acid.

ACTIONS

K-PHOS® ORIGINAL is a highly effective sodium-free urinary acidifier.

INDICATONS AND USAGE

For use in patients with elevated urinary pH. K-PHOS® ORIGINAL helps keep calcium soluble and reduces odor and rash caused by ammoniacal urine. Also, by acidifying the urine, it increases the antibacterial activity of methenamine mandelate and methenamine hippurate.

CONTRAINDICATIONS

This product is contraindicated in patients with infected phosphate stones; in patients with severely impaired renal function (less than 30% of normal) and in the presence of hyperphosphatemia and hyperkalemia.

PRECAUTIONS

General

This product contains potassium and should be used with caution if regulation of this element is desired. Occasionally, some individuals may experience a mild laxative effect during the first few days of phosphate therapy. If laxation persists to an unpleasant degree, reduce the daily dosage until this effect subsides or, if necessary, discontinue the use of this product.

Caution should be exercised when prescribing this product in the following conditions: Cardiac disease ; severe adrenal insufficiency (Addison's disease); acute dehydration; severe renal insufficiency or chronic renal disease; extensive tissue breakdown (such as severe burns); myotonia congenita; hypoparathyroidism; and acute pancreatitis. Rickets may benefit from phosphate therapy, but caution should be exercised. High serum phosphate levels may increase the incidence of extra-skeletal calcification.

Information for Patients

Patients with kidney stones may pass old stones when phosphate therapy is started and should be warned of this possibility. Patients should be advised to avoid the use of antacids containing aluminum, calcium, or magnesium, which may prevent the absorption of phosphate. To assure against gastrointestinal injury associated with oral ingestion of concentrated potassium salt preparations, patients should be instructed to dissolve tablets completely in an appropriate amount of water before taking.

Laboratory Tests

Careful monitoring of renal function and serum calcium, phosphorus and potassium may be required at periodic intervals during potassium phosphate therapy. Other tests may be warranted in some patients, depending on conditions.

Drug Interactions

The use of antacids containing magnesium, calcium, or aluminum in conjunction with phosphate preparations may bind the phosphate and prevent its absorption. Potassium-containing medications or potassium-sparing diuretics may cause hyperkalemia when used concurrently with potassium salts. Patients should have serum potassium level determinations at periodic intervals. Concurrent use of salicylates may lead to increased serum salicylate levels since excretion of salicylates is reduced in acidified urine. Serum salicylate levels should be closely monitored to avoid toxicity.

Carcinogenesis, Mutagenesis, Impairment of Fertility

No long-term or reproduction studies in animals or humans have been performed with K-PHOS® ORIGINAL to evaluate its carcinogenic, mutagenic, or impairment of fertility potential.

Pregnancy

Teratogenic Effects

Pregnancy Category C

Animal reproduction studies have not been conducted with K-PHOS® ORIGINAL. It is also not known whether this product can cause fetal harm when administered to a pregnant woman or can affect reproductive capacity. This product should be given to a pregnant woman only if clearly needed.

Nursing Mothers

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

ADVERSE REACTIONS

Gastrointestinal upset (diarrhea, nausea, stomach pain, and vomiting) may occur with the use of potassium phosphate. Also, bone and joint pain (possible phosphate-induced osteomalacia) could occur. The following adverse effects may be observed with potassium administration: irregular heartbeat; dizziness; mental confusion; weakness or heaviness of legs; unusual tiredness; muscle cramps; numbness, tingling, pain, or weakness in hands or feet; numbness or tingling around lips; shortness of breath or troubled breathing.

DOSAGE AND ADMINISTRATION

Two tablets dissolved in 6-8 oz. of water 4 times daily with meals and at bedtime. For best results, let the tablets soak in water for 2 to 5 minutes, or more if necessary, and stir. If any tablet particles remain undissolved, they may be crushed and stirred vigorously to speed dissolution.

HOW SUPPLIED

NDC:68151-2193-0 in a PACKAGE of 1 TABLET, SOLUBLES

STORAGE

Keep tightly closed. Store at controlled room temperature, 20°-25°C (68°-77°F).

Dispense in tight, light-resistant containers with child-resistant closures.

BEACH PHARMACEUTICALS, Div. of Beach Products, Inc., Tampa, FL 33611

Rev: 07/09B

Potassium Acid Phosphate 500 mg tabs