Moxif Infusions

Mannitol:

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

INDICATIONS AND USAGE

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

CONTRAINDICATIONS

5% Moxif Infusions (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 Moxif Infusions (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% Moxif Infusions 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% Moxif Infusions (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% Moxif Infusions (Mannitol) may cause loss of water in excess of electrolytes and produce hypernatremia.

Sustained diuresis from transurethral irrigation with 5% Moxif Infusions (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% Moxif Infusions (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% Moxif Infusions Irrigation. It is also not known whether 5% Moxif Infusions (Mannitol) Irrigation can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. 5% Moxif Infusions (Mannitol) Irrigation should be given to a pregnant woman only if clearly needed.

Nursing Mothers

Caution should be exercised when 5% Moxif Infusions (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% Moxif Infusions (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 Moxif Infusions (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% Moxif Infusions (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% Moxif Infusions (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% Moxif Infusions (Mannitol) Irrigation

For Urologic Irrigation

REF R6515-01

NDC 0264-2303-50

DIN 01963953

2000 mL

Lot

Exp.

Each 100 mL contains:

Moxif Infusions (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

Moxifloxacin Hydrochloride:

• Moxif Infusions information
• Moxif Infusions indications
• Moxif Infusions warnings
• Moxif Infusions intake guidelines
• Moxif Infusions dosage
• Moxif Infusions overdose
• Moxif Infusions missed dose
• Moxif Infusions side effects
• Moxif Infusions drug interactions
• Moxif Infusions (Moxifloxacin Hydrochloride) reviews

Moxif Infusions information

This medication, also known as moxifloxacin, is a drug that belongs to a wide class of medicines called fluoroquinolones. Fluoroquinolones (therefore, also Moxif Infusions (Moxifloxacin Hydrochloride)) helps the body's immune system fight against bacteria that causes harmful effects.

Moxif Infusions indications

Moxif Infusions (Moxifloxacin Hydrochloride) is usually prescribed in the treatment of "popular" bacterial infections like the following ones:

Pneumonia

Chronic bronchitis

Sinusitis

Moxif Infusions warnings

You should discuss with your doctor before starting a treatment with Moxif Infusions (Moxifloxacin Hydrochloride). Inform your personal physician if you are suffering or have recently suffered from any of the following conditions:

You or a member of your family has suffered from any type of heart disorder (such as QT interval prolongation) If you have followed a treatment with heart medicines such as quinidine (Quinaglute, Cardioquin, Quinidex), procainamide (Procan SR, Pronestyl), amiodarone (Pacerone, Cordarone), sotalol (Betapace), etc.

Slow heart rate

Low level of K+ in the blood

Liver disease

Heart disease

Epilepsy or any other disorders that cause seizures

If you have been suffering from any of the conditions mentioned above you might not be allowed to take Moxif Infusions (Moxifloxacin Hydrochloride) or your doctor might want to monitor your treatment or to make necessary dosage adjustments.

Moxif Infusions (Moxifloxacin Hydrochloride) is a Category C FDA Pregnancy drug. Therefore, it has not been clearly established whether this drug can cause harm to an unborn child or to the carrying mother. If you are pregnant or are planning to be so soon, you should consult with your doctor before starting a treatment with this drug. Moxif Infusions (Moxifloxacin Hydrochloride) is known to pass into breast milk. If you are breastfeeding an infant you should not start taking this medicine without consulting it with your physician.

This drug should not be prescribed in patients under 18 years old.

Moxif Infusions intake guidelines

You should accompany each and every dose of Moxif Infusions (Moxifloxacin Hydrochloride) that you take with a glass of water. You may take this drug either on a full or on an empty stomach. Drink plenty of water during your treatment with Moxif Infusions (Moxifloxacin Hydrochloride) (Moxifloxacin). Do not stop your treatment with Moxif Infusions (Moxifloxacin Hydrochloride) without your doctor's consent.

Moxif Infusions dosage

Ask your doctor to calculate the dose of Moxif Infusions (Moxifloxacin Hydrochloride) that suits you best. The correct dosage varies from one person to another, as it depends on a couple of factors. This drug is usually taken only once a day.

Moxif Infusions overdose

If you are suffering from overdose with this drug you might have some of the following symptoms:

Poor coordination

Diarrhea

Seizures

Sleepiness

Tremors

Vomiting

If you are experiencing any of the symptoms listed here, you are in need of medical attention (inform your doctor immediately).

Moxif Infusions missed dose

Moxifloxacin should be taken in or on a regular basis. If you are following a treatment with Moxif Infusions (Moxifloxacin Hydrochloride), try not to miss any of your doses. If you happen to miss one take it as soon as possible and continue with your regular schedule. You should not take in a double dose of this drug unless you are instructed by your physician to do so.

Moxif Infusions side effects

Among this drug's serious side effects are:

Allergy to the drug or some of its components (difficulty in breathing, throat closure, swelling of the tongue, lips, face, and sometimes hives)

Rapid or irregular pulse

Seizures

Fainting

Liver damage (nausea, yellowing of the eyes or skin, abdominal discomfort or pain, abnormal bruising or bleeding, fatigue)

Skin rashes

Joint or muscle pains

If you are experiencing these side effects stop your treatment and inform your physician.

Moxif Infusions (Moxifloxacin Hydrochloride) can also induce other side effects (more common and less serious) such as:

Vomiting, nausea, diarrhea or abdominal pain

Headache

Dizziness

Increased skin sensitivity to direct sunlight

These mild side effects shouldn't stop you from continuing with your treatment. However, you should inform your doctor at once.

Other side effects may also occur when you take Moxif Infusions (Moxifloxacin Hydrochloride). Inform your physician immediately if you experience anything unusual while taking this drug.

Moxif Infusions drug interactions

You should consult with your personal physician before you start a treatment with Moxif Infusions (Moxifloxacin Hydrochloride). This drug can interact with drugs such as herbal products, vitamins and minerals. Among these drugs there are warfarin (Coumadin); or an anti-inflammatory non-steroidal drug (NSAID) like ibuprofen (Nuprin, Motrin, and Advil), naproxen (Naprosyn, Aleve, and Anaprox), ketoprofen (Oruvail, Orudis KT, and Orudis) and other drugs that have not been mentioned here.

Please inform you personal doctor if you are following a treatment with any of the following medicines:

Heart medicines such as quinidine (Quinaglute, Cardioquin, Quinidex), procainamide (Procan SR, Pronestyl), amiodarone (Pacerone, Cordarone), sotalol (Betapace) and any other medicine of this type

Tricyclic antidepressants such as amitriptyline (Endep, Elavil), Imipramine (Tofranil), amoxapine (Asendin), thioridazine (Mellaril), mesoridazine (Serentil), and others Erythromycin (Ery-Tab, E-Mycin, E.E.S, and any other drugs of this type)

Cisapride (Propulsid)

All the medicines stated above affect your regular pulse. You might need Moxif Infusions (Moxifloxacin Hydrochloride) dosage adjustments or special monitoring during your treatment with Moxif Infusions (Moxifloxacin Hydrochloride) if you are taking these drugs.