Go PLR Articles Directory Saint Vincent and the Grenadines: July 2010

Saturday, July 31, 2010

Oxaliplatine EG

Oxaliplatine EG may be available in the countries listed below.

Ingredient matches for Oxaliplatine EG

Oxaliplatin

Oxaliplatin is reported as an ingredient of Oxaliplatine EG in the following countries:

Belgium

International Drug Name Search

Tuesday, July 27, 2010

Laxaron

Laxaron may be available in the countries listed below.

Ingredient matches for Laxaron

Lactulose

Lactulose is reported as an ingredient of Laxaron in the following countries:

France

International Drug Name Search

Thursday, July 22, 2010

Pentin-LA

Pentin-LA may be available in the countries listed below.

Ingredient matches for Pentin-LA

Benzylpenicillin

Benzylpenicillin is reported as an ingredient of Pentin-LA in the following countries:

Turkey

International Drug Name Search

Thursday, July 8, 2010

Betabion

Betabion may be available in the countries listed below.

Ingredient matches for Betabion

Betaxolol

Betaxolol hydrochloride (a derivative of Betaxolol) is reported as an ingredient of Betabion in the following countries:

Poland

Thiamine

Thiamine hydrochloride (a derivative of Thiamine) is reported as an ingredient of Betabion in the following countries:

Germany

Sweden

International Drug Name Search

Monday, July 5, 2010

NAC-CT

NAC-CT may be available in the countries listed below.

Ingredient matches for NAC-CT

Acetylcysteine

Acetylcysteine is reported as an ingredient of NAC-CT in the following countries:

Germany

International Drug Name Search

Pronunciation: brome-fen-IR-a-meen/dex-troe-meth-OR-fan/sue-do-eh-FED-rin
Generic Name: Brompheniramine/Dextromethorphan/Pseudoephedrine
Brand Name: Examples include Bromfed DM and Carbodex DM

Bromfed DM Elixir is used for:

Relieving symptoms of sinus congestion, runny nose, sneezing, and cough due to colds, upper respiratory infections, and allergies. It may also be used for other conditions as determined by your doctor.

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

Do NOT use Bromfed DM Elixir if:

you are allergic to any ingredient in Bromfed DM Elixir

you have severe high blood pressure, severe heart blood vessel disease, rapid heartbeat, or severe heart problems

you are unable to urinate or are having an asthma attack

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

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

Before using Bromfed DM Elixir:

Some medical conditions may interact with Bromfed DM Elixir. 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 fast, slow, or irregular heartbeat

if you have a history of adrenal gland problems (eg, adrenal gland tumor); heart problems; high blood pressure; diabetes; heart blood vessel problems; stroke; glaucoma; a blockage of your stomach, bladder, or intestines; ulcers; trouble urinating; an enlarged prostate or other prostate problems; seizures; or an overactive thyroid

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

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

Beta-blockers (eg, propranolol), COMT inhibitors (eg, tolcapone), furazolidone, indomethacin, MAOIs (eg, phenelzine), sodium oxybate (GHB), or tricyclic antidepressants (eg, amitriptyline) because they may increase the risk of Bromfed DM Elixir's side effects

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

Bromocriptine or hydantoins (eg, phenytoin) because the risk of their side effects may be increased by Bromfed DM Elixir

Guanadrel, guanethidine, mecamylamine, methyldopa, or reserpine because their effectiveness may be decreased by Bromfed DM Elixir

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

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

Take Bromfed DM Elixir by mouth with or without food.

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

If you miss a dose of Bromfed DM Elixir, take it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once.

Ask your health care provider any questions you may have about how to use Bromfed DM Elixir.

Important safety information:

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

Do not take diet or appetite control medicines while you are taking Bromfed DM Elixir without checking with you doctor.

Bromfed DM Elixir has pseudoephedrine in it. Before you start any new medicine, check the label to see if it has pseudoephedrine in it too. If it does or if you are not sure, check with your doctor or pharmacist.

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

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

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

If you are scheduled for allergy skin testing, do not take Bromfed DM Elixir for several days before the test because it may decrease your response to the skin tests.

Tell your doctor or dentist that you take Bromfed DM Elixir before you receive any medical or dental care, emergency care, or surgery.

Use Bromfed DM Elixir with caution in the ELDERLY; they may be more sensitive to its effects.

Caution is advised when using Bromfed DM Elixir in CHILDREN; they may be more sensitive to its effects.

PREGNANCY and BREAST-FEEDING: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Bromfed DM Elixir while you are pregnant. It is not known if Bromfed DM Elixir is found in breast milk. Do not breast-feed while taking Bromfed DM Elixir.

Possible side effects of Bromfed DM Elixir:

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Constipation; diarrhea; dizziness; drowsiness; excitability; headache; loss of appetite; nausea; nervousness or anxiety; trouble sleeping; upset stomach; vomiting; weakness.

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

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); difficulty urinating or inability to urinate; fast or irregular heartbeat; hallucinations; seizures; severe dizziness, lightheadedness, or headache; tremor; trouble sleeping; vision changes.

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: Bromfed DM side effects (in more detail)

If OVERDOSE is suspected:

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

Proper storage of Bromfed DM Elixir:

Store Bromfed DM Elixir at room temperature, between 59 and 86 degrees F (15 and 30 degrees C). Store away from heat, moisture, and light. Do not store in the bathroom. Keep Bromfed DM Elixir out of the reach of children and away from pets.

General information:

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

Bromfed DM Elixir 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 Bromfed DM Elixir. 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 Bromfed DM resources

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

Compare Bromfed DM with other medications

Cough and Nasal Congestion

Friday, July 2, 2010

Dianeal Low Calcium Peritoneal Dialysis Solution

Dosage Form: injection, solution
Dianeal Low Calcium Peritoneal Dialysis Solution

AMBU-FLEX Container For Peritoneal Dialysis

For intraperitoneal administration only

Dianeal Low Calcium Peritoneal Dialysis Solution Description

Dianeal Low Calcium Peritoneal Dialysis Solutions in AMBU-FLEX containers are sterile, nonpyrogenic solutions for intraperitoneal administration only. They contain no bacteriostatic or antimicrobial agents or added buffers.

Composition, calculated osmolarity, pH and ionic concentrations are shown in Table 1.

Potassium is omitted from peritoneal dialysis solutions because dialysis may be performed to correct hyperkalemia. In situations in which there is a normal serum potassium level or hypokalemia, the addition of potassium chloride (up to a concentration of 4 mEq/L) may be indicated to prevent severe hypokalemia. Addition of potassium chloride should be made after careful evaluation of serum and total body potassium and only under the direction of a physician. Frequent monitoring of serum electrolytes is indicated.

In some patients calcium carbonate is used as a phosphate binder. Because serum calcium levels have been observed to be elevated in these patients (Slatopolsky et al. 1986), the calcium concentration of Dianeal Low Calcium Peritoneal Dialysis Solutions has been reduced to 2.5 mEq/L. Serum calcium levels should be monitored and if low, the amount of oral calcium carbonate phosphate binder may be increased or peritoneal dialysis solutions containing higher calcium concentrations may be used. If serum calcium levels rise, adjustments to the dosage of the calcium carbonate phosphate binder and/or vitamin D analogs should be considered by the physician.

Because average plasma magnesium levels in some chronic CAPD patients have been observed to be elevated (Nolph et al. 1981), the magnesium concentration of this formulation has been reduced to 0.5 mEq/L. Average plasma magnesium levels have not been reported for chronic IPD and CCPD patients. Serum magnesium levels should be monitored and if low, oral magnesium supplements, oral magnesium containing phosphate binders, or peritoneal dialysis solutions containing higher magnesium concentrations may be used.

Because average serum bicarbonate levels in some chronic CAPD patients (Nolph et al. 1981), some chronic IPD patients (La Greca et al. 1980), and some chronic CCPD patients (Diaz-Buxo et al. 1983), have been observed to be somewhat lower than normal values, the bicarbonate precursor (lactate) concentration of Dianeal Low Calcium Peritoneal Dialysis Solutions has been raised to 40 mEq/L. Serum bicarbonate levels should be monitored.

The osmolarities shown in Table 1 are calculated values. Calculated osmolarity of Dianeal Low Calcium Peritoneal Dialysis Solution with 1.5% dextrose is 344 mOsmol/L, compared with measured values in normal human serum of 280 mOsmol/L.

The plastic container is fabricated from a specially formulated polyvinyl chloride (PL 146 Plastic). The amount of water that can permeate from inside the container into the overpouch is insufficient to affect the solution significantly. Solutions in contact with the plastic container can leach out certain of its chemical components in very small amounts within the expiration period, e.g., di-2-ethylhexyl phthalate (DEHP), up to 5 parts per million; however, the safety of the plastic has been confirmed in tests in animals according to USP biological tests for plastic containers as well as by tissue culture toxicity studies.

Dianeal Low Calcium Peritoneal Dialysis Solution - Clinical Pharmacology

Peritoneal dialysis is a procedure for removing toxic substances and metabolites normally excreted by the kidneys, and for aiding in the regulation of fluid and electrolyte balance.

The procedure is accomplished by instilling peritoneal dialysis fluid through a conduit into the peritoneal cavity. With the exception of lactate, present as a bicarbonate precursor, electrolyte concentrations in the fluid have been formulated in an attempt to normalize plasma electrolyte concentrations resulting from osmosis and diffusion across the peritoneal membrane (between the patient’s plasma and the dialysis fluid). Toxic substances and metabolites, present in high concentrations in the blood, cross the peritoneal membrane into the dialyzing fluid. Dextrose in the dialyzing fluid is used to produce a solution hyperosmolar to the plasma, creating an osmotic gradient which facilitates fluid removal from the patient’s plasma into the peritoneal cavity. After a period of time (dwell time), the fluid is drained from the cavity.

Indications and Usage for Dianeal Low Calcium Peritoneal Dialysis Solution

Dianeal Low Calcium Peritoneal Dialysis Solutions are indicated for use in chronic renal failure patients being maintained on peritoneal dialysis.

Contraindications

None known.

Warnings

Peritoneal dialysis should be done with great care, if at all, in patients with a number of abdominal conditions including disruption of the peritoneal membrane or diaphragm by surgery or trauma, extensive adhesions, bowel distention, undiagnosed abdominal disease, abdominal wall infection, hernias or burns, fecal fistula or colostomy, tense ascites, obesity, and large polycystic kidneys (Vaamonde and Perez 1977). Other conditions include recent aortic graft replacement and severe pulmonary disease. When assessing peritoneal dialysis as the mode of therapy in such extreme situations, the benefits to the patient must be weighed against the possible complications.

An accurate fluid balance record must be kept and the weight of the patient carefully monitored to avoid over or under hydration with severe consequences including congestive heart failure, volume depletion, and shock.

Excessive use of Dianeal Low Calcium Peritoneal Dialysis Solution with 3.5% or 4.25% dextrose during a peritoneal dialysis treatment can result in significant removal of water from the patient.

Stable patients undergoing maintenance peritoneal dialysis should have routine periodic evaluation of blood chemistries and hematologic factors, as well as other indicators of patient status.

Not for use in the treatment of lactic acidosis.

Potassium is omitted from Dianeal Low Calcium Peritoneal Dialysis Solutions because dialysis may be performed to correct hyperkalemia. Addition of potassium chloride should be made after careful evaluation of serum and total body potassium and only under the direction of a physician.

The use of 5 or 6 liters of dialysis solution is not indicated in a single exchange.

Refer to manufacturer’s directions accompanying drugs to obtain full information on additives.

If the resealable rubber plug on the medication port is missing or partially removed, do not use product if medication is to be added.

After the pull ring has been removed, inspect connector of solution container for fluid flow. A few drops of solution within the connector or pull ring may be present due to condensation of water resulting from the sterilization process. If a continuous stream of fluid is noted, discard solution because sterility may be impaired.

After removing overpouch, check for minute leaks by squeezing container firmly. If leaks are found, discard the solution because the sterility may be impaired.

Freezing of solution may occur at temperatures below 0°C (32°F). Allow to thaw naturally in ambient conditions and thoroughly mix contents by shaking.

Precautions

Aseptic technique must be used throughout the procedure and at its termination in order to reduce the possibility of infection. If peritonitis occurs, the choice and dosage of antibiotics should be based upon the results of identification and sensitivity studies of the isolated organism(s) when possible. Prior to identification of the involved organism(s), broad-spectrum antibiotics may be indicated.

Peritoneal dialysis solutions may be warmed in the overpouch to 37°C (98.6°F) to enhance patient comfort. However, only dry heat (for example, heating pad) should be used. Solutions should not be heated in water due to an increased risk of infection. Microwave ovens should not be used to heat solutions because there is a potential for damage to the solution container. Moreover, microwave oven heating may potentially cause overheating and/or non-uniform heating of the solution that may result in patient injury or discomfort.

Significant losses of protein, amino acids and water soluble vitamins may occur during peritoneal dialysis. Replacement therapy should be provided as necessary.

Pregnancy

Teratogenic Effects

Pregnancy Category C

Animal reproduction studies have not been conducted with Dianeal Low Calcium Peritoneal Dialysis Solutions. It is also not known whether Dianeal Low Calcium Peritoneal Dialysis Solutions can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Dianeal Low Calcium Peritoneal Dialysis Solutions should be given to a pregnant woman only if clearly needed.

Do not administer unless solution is clear and seal is intact.

Adverse Reactions

Adverse reactions to peritoneal dialysis include mechanical and solution related problems as well as the results of contamination of equipment or improper technique in catheter placement. Abdominal pain, bleeding, peritonitis, subcutaneous infection around a chronic peritoneal catheter, catheter blockage, difficulty in fluid removal, and ileus are among the complications of the procedure. Solution related adverse reactions may include electrolyte and fluid imbalances, hypovolemia, hypervolemia, hypertension, hypotension, disequilibrium syndrome, and muscle cramping.

When prescribing the solution to be used for an individual patient, consideration should be given to the potential interaction between the dialysis treatment and therapy directed at other existing illnesses. For example, rapid potassium removal may create arrhythmias in cardiac patients using digitalis or similar drugs; digitalis toxicity may be masked by elevated potassium or magnesium, or by hypocalcemia. Correction of electrolytes by dialysis may precipitate signs and symptoms of digitalis excess. Conversely, toxicity may occur at suboptimal dosages of digitalis if potassium is low or calcium high. Azotemic diabetics require careful monitoring of insulin requirements during and following dialysis with dextrose containing solutions.

Dianeal Low Calcium Peritoneal Dialysis Solution Dosage and Administration

Dianeal Low Calcium Peritoneal Dialysis Solutions are intended for intraperitoneal administration only.

Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration whenever solution and container permit.

The mode of therapy (Intermittent Peritoneal Dialysis [IPD], Continuous Ambulatory Peritoneal Dialysis [CAPD], or Continuous Cyclic Peritoneal Dialysis [CCPD]), frequency of treatment, formulation, exchange volume, duration of dwell, and length of dialysis should be selected by the physician responsible for and supervising the treatment of the individual patient.

To avoid the risk of severe dehydration and hypovolemia and to minimize the loss of protein, it is advisable to select the peritoneal dialysis solution with the lowest level of osmolarity consistent with the fluid removal requirements for that exchange.

Peritoneal dialysis solutions may be warmed in the overpouch to 37°C (98.6°F) to enhance patient comfort. However, only dry heat (for example, heating pad) should be used. (See Directions for Use)

The addition of heparin to the dialysis solution may be indicated to aid in prevention of catheter blockage in patients with peritonitis, or when the solution drainage contains fibrinous or proteinaceous material (Ribot et al. 1966). 1000 to 2000 USP units of heparin per liter of solution has been recommended for adults (Furman et al. 1978). For children, 50 units of heparin per 100 mL of dialysis fluid has been recommended (Irwin et al. 1981).

Additives may be incompatible. Complete information is not available. Those additives known to be incompatible should not be used. Consult with pharmacist, if available. If, in the informed judgment of the physician, it is deemed advisable to introduce additives, use aseptic technique. Mix thoroughly when additives have been introduced. Do not store solutions containing additives.

Intermittent Peritoneal Dialysis (IPD)

For maintenance dialysis of chronic renal failure patients.

The cycle of instillation, dwell and removal of dialysis fluid is repeated sequentially over a period of hours (8 to 36 hours) as many times per week as indicated by the condition of the patient. For chronic renal failure patients, maintenance dialysis is often accomplished by periodic dialysis (3 to 5 times weekly) for shorter time periods (8 to 14 hours per session) (Mattocks and El-Bassiouni 1971).

Continuous Ambulatory Peritoneal Dialysis (CAPD) and Continuous Cyclic Peritoneal Dialysis (CCPD)

For maintenance dialysis of chronic renal failure patients.

In CAPD, typically 1.5 to 3.0 liters of dialysis solution (depending upon patient size) are instilled into the peritoneal cavity of adults and the peritoneal access device is then clamped (Kim et al. 1984; Twardowski and Janicka 1981; Twardowski and Burrows 1984). For children, 30 to 50 mL/kg body weight with a maximum of 2 liters has been recommended (Potter et al. 1981; Irwin et al. 1981). The solution remains in the cavity for dwell times of 4 to 8 hours during the day and 8 to 12 hours overnight. At the conclusion of each dwell period, the access device is opened, the solution drained and fresh solution instilled. The procedure is repeated 3 to 5 times per day, 6 to 7 days per week. Solution exchange volumes and frequency of exchanges should be individualized for adequate biochemical and fluid volume control (Moncrief et al. 1982; Twardowski et al. 1983). The majority of exchanges will utilize 1.5% or 2.5% dextrose containing peritoneal dialysis solutions, with 3.5% or 4.25% dextrose containing solutions being used when extra fluid removal is required. Patient weight is used as the indicator of the need for fluid removal (Popovich et al. 1978).

In CCPD, the patient receives 3 or 4 dialysis exchanges during the night which range from 2-1/2 to 3 hours dwell duration. Typically 1.5 to 2.0 liters of dialysis solution (depending upon patient size) are delivered each cycle by an automatic peritoneal dialysis cycler machine. After the last outflow during the night, an additional exchange is infused by the cycler machine into the peritoneum. The equipment is then disconnected from the patient, and the dialysate remains in the peritoneum for 14 to 15 hours during the day until the next nocturnal cycle (Diaz-Buxo et al. 1981). Combinations of 1.5% or 2.5% dextrose containing peritoneal dialysis solutions are usually used for the nighttime exchanges, while 3.5% or 4.25% dextrose containing solution is used when extra fluid removal is required such as during the daytime exchange. Patient weight is used as the indicator of the need for fluid removal (Popovich et al. 1978) so therapy should be individualized according to the patient’s need for ultrafiltration.

It is recommended that adult patients being placed on peritoneal dialysis or, in the case of pediatric patients, the selected caretaker, (as well as the patient, when suitable), should be appropriately trained in a program which is under the supervision of a physician. Training materials are available from Baxter Healthcare Corporation, Deerfield, IL 60015 USA to facilitate this training.

How is Dianeal Low Calcium Peritoneal Dialysis Solution Supplied

Dianeal Low Calcium Peritoneal Dialysis Solutions in AMBU-FLEX II and AMBU-FLEX III containers are available in nominal size flexible containers with fill volumes as indicated in Table 1.

All Dianeal Low Calcium Peritoneal Dialysis Solutions have overfills which are declared on container labeling.

Exposure of pharmaceutical products to heat should be minimized. Avoid excessive heat. It is recommended the product be stored at room temperature (25°C/77°F): brief exposure up to 40°C (104°F) does not adversely affect the product.

Directions for Use

Use aseptic technique.

For complete system preparation, see directions accompanying ancillary equipment.

To Open

Tear overpouch down side at slit and remove solution container. Some opacity of the plastic due to moisture absorption during the sterilization process may be observed. This is normal and does not affect the solution quality or safety. The opacity will diminish gradually. If supplemental medication is desired, follow directions below before preparing for administration. Check for minute leaks by squeezing container firmly.

To Add Medication

Additives may be incompatible.

If the resealable rubber plug on the medication port is missing or partially removed, do not use product if medication is to be added.

Put on mask. Clean and/or disinfect hands.

Prepare medication site using aseptic technique.

Using a syringe with a 1 inch long 19 to 25 gauge needle, puncture resealable medication port and inject medication.

Position container with ports up and evacuate the medication port by squeezing and tapping it.

Mix solution and medication thoroughly.

Preparation for Administration

Put on mask. Clean and/or disinfect hands.

Place solution container on work surface.

Remove pull ring from connector of the solution container. If continuous fluid flow from connector is observed, discard solution container.

Remove tip protector from tubing set and immediately attach to connector of the solution container.

Continue with therapy set-up as instructed in user manual or directions accompanying tubing sets.

Upon completion of therapy, discard unused portion.

REFERENCES

Diaz-Buxo, J.A. et al. 1981. Continuous cyclic peritoneal dialysis: a preliminary report. Int Soc Artif Organs 81:157-161.

Diaz-Buxo, J.A. et al. 1983. Observations on inadequate base buffer concentrations in peritoneal dialysis solutions. ASAIO Abstracts 43.

Furman, K.I. et al. 1978. Activity of intraperitoneal heparin during peritoneal dialysis. Clinical Nephrology 9:15-18.

Irwin, M.A. et al. 1981. Continuous ambulatory peritoneal dialysis in pediatrics. AANNT J 8:11-13, 44.

Kim, D. et al. 1984. Continuous ambulatory peritoneal dialysis with three-liter exchanges: a prospective study. Peritoneal Dial Bull 4:82-85.

La Greca, G. et al. 1980. Acid base balance on peritoneal dialysis. Clinical Nephrology 16(1):1-6.

Mattocks, A.M. and El-Bassiouni, E.A. 1971. Peritoneal dialysis: a review. J Pharm Sci 60:1767-1782.

Moncrief, J.W. et al. 1982. CAPD: Are three exchanges per day adequate? AANNT J 9:39-43.

Nolph, K.D. et al. 1981. Considerations for dialysis solution modifications. In Peritoneal Dialysis, eds. Robert C. Atkins et al. Chapter 25. New York: Churchill Livingston.

Popovich, R.P. et al. 1978. Continuous ambulatory peritoneal dialysis. Ann Intern Med 8:449-456.

Potter, D.E. et al. 1981. Continuous ambulatory dialysis (CAPD) in children. Trans Am Soc Artif Intern Organs 27:64-67.

Ribot, S. et al. 1966. Complications of peritoneal dialysis. Am J Med Sci 252:505-517.

Slatopolsky, E. et al. 1986. Calcium carbonate as a phosphate binder in patients with chronic renal failure undergoing dialysis. NEJM 3:315, 157-160.

Twardowski, Z.J. and Janicka, L. 1981. Three exchanges with a 2.5 liter volume for continuous ambulatory peritoneal dialysis. Kidney Int 20:281-284.

Twardowski, Z.J. et al. 1983. High volume low frequency continuous ambulatory peritoneal dialysis. Kidney Int 23:64-70.

Twardowski, Z.J. and Burrows, L. 1984. Two year experience with high volume, low frequency continuous ambulatory peritoneal dialysis. Peritoneal Dial Bull 4:S67.

Vaamonde, C.A. and Perez, G.O. 1977. Peritoneal dialysis today. Kidney 10:31-36.

Table 1

Composition/100mL

OSMOLARITY (mOsmol/L) (calc)

Ionic Concentration

(mEq/L)

How Supplied

*Dextrose, Hydrous, USP

Sodium

Chloride, USP

(NaCl)

Sodium Lactate

(C3H5NaO3)

Calcium Chloride, USP

(CaCl2•2H2O)

Magnesium Chloride, USP

(MgCl2•6H2O)

Sodium

Calcium

Magnesium

Chloride

Lactate

Fill

Volume

(mL)

Container

Size

(mL)

Code

NDC

Dianeal Low Calcium Peritoneal Dialysis Solution with 1.5% Dextrose

AMBU-FLEX II Container

1.5 g

538 mg

448 mg

18.3 mg

5.08 mg

344

5.2

(4.0 to 6.5)

132

2.5

0.5

2000

2500

3000

5000

6000

3000

3000

3000

6000

6000

L5B4825

L5B9718

L5B9901

L5B4826

L5B9770

NDC 0941-0409-06

NDC 0941-0409-08

NDC 0941-0409-05

NDC 0941-0409-07

NDC 0941-0409-01

DIANEAL Low Calcium Peritoneal Dialysis Solution with 1.5% Dextrose

AMBU-FLEX III Container

1.5 g

538 mg

448 mg

18.3 mg

5.08 mg

344

5.2

(4.0 to 6.5)

132

2.5

0.5

1500

2000

2500

3000

5000

6000

2000

2000

3000

3000

5000

6000

5B9715

5B4825

5B9718

5B9901

5B4826

5B9770

NDC 0941-0409-45

NDC 0941-0409-36

NDC 0941-0409-48

NDC 0941-0409-49

NDC 0941-0409-27

NDC 0941-0409-28

Dianeal Low Calcium Peritoneal Dialysis Solution with 2.5% Dextrose

AMBU-FLEX II Container

2.5 g

538 mg

448 mg

18.3 mg

5.08 mg

395

5.2

(4.0 to 6.5)

132

2.5

0.5

2000

2500

3000

5000

6000

3000

3000

3000

6000

6000

L5B9727

L5B9728

L5B9902

L5B5202

L5B9771

NDC 0941-0457-08

NDC 0941-0457-07

NDC 0941-0457-02

NDC 0941-0457-05

NDC 0941-0457-01

DIANEAL Low Calcium Peritoneal Dialysis Solution with 2.5% Dextrose

AMBU-FLEX III Container

2.5 g

538 mg

448 mg

18.3 mg

5.08 mg

395

5.2

(4.0 to 6.5)

132

2.5

0.5

1500

2000

2500

3000

5000

6000

2000

3000

3000

3000

5000

6000

5B9725

5B9727

5B9728

5B9902

5B5202

5B9771

NDC 0941-0457-45

NDC 0941-0457-47

NDC 0941-0457-48

NDC 0941-0457-49

NDC 0941-0457-25

NDC 0941-0457-28

DIANEAL Low Calcium Peritoneal Dialysis Solution with 3.5% Dextrose AMBU-FLEX III Container

3.5 g

538 mg

448 mg

18.3 mg

5.08 mg

445

5.2

(4.0 to 6.5)

132

2.5

0.5

2500

3000

5B9738

NDC 0941-0463-48

Dianeal Low Calcium Peritoneal Dialysis Solution with 4.25% Dextrose

AMBU-FLEX II Container

4.25 g

538 mg

448 mg

18.3 mg

5.08 mg

483

5.2

(4.0 to 6.5)

132

2.5

0.5

2000

2500

3000

5000

6000

3000

3000

3000

6000

6000

L5B9747

L59B748

L5B9903

L5B5203

L5B9772

NDC 0941-0459-08

NDC 0941-0459-07

NDC 0941-0459-02

NDC 0941-0459-05

NDC 0941-0459-01

DIANEAL Low Calcium Peritoneal Dialysis Solution with 4.25% Dextrose

AMBU-FLEX III Container

4.25 g

538 mg

448 mg

18.3 mg

5.08 mg

483

5.2

(4.0 to 6.5)

132

2.5

0.5

1500

2000

2500

3000

5000

6000

2000

3000

3000

3000

5000

6000

5B9745

5B9747

5B9748

5B9903

5B5203

5B9772

NDC 0941-0459-45

NDC 0941-0459-47

NDC 0941-0459-48

NDC 0941-0459-49

NDC 0941-0459-25

NDC 0941-0459-28

Baxter, DIANEAL, AMBU-FLEX, and PL 146 are trademarks of

Baxter International Inc.

Baxter Healthcare Corporation

Deerfield, IL 60015 USA

Printed in USA

07-19-60-956

2009/08

PACKAGE LABEL - PRINCIPAL DISPLAY PANEL

Container Label

L5B4825

NDC 0941-0409-06

2000 mL

(APPROX 80 mL EXCESS)

Baxter

Dianeal

Low Calcium (2.5 mEq/L)

Peritoneal Dialysis Solution

with 1.5% Dextrose

Low Calcium 1.5% Dextrose

EACH 100 mL CONTAINS 1.5 g DEXTROSE HYDROUS USP

538 mg SODIUM CHLORIDE USP 448 mg SODIUM

LACTATE 18.3 mg CALCIUM CHLORIDE USP 5.08 mg

MAGNESIUM CHLORIDE USP pH 5.2 (4.0 TO 6.5)

mEq/L SODIUM - 132 CALCIUM - 2.5 MAGNESIUM -

0.5 CHLORIDE - 95 LACTATE - 40

OSMOLARITY - 344 mOsmol/L (CALC)

STERILE NONPYROGENIC

POTASSIUM CHLORIDE TO BE ADDED ONLY

UNDER THE DIRECTION OF A PHYSICIAN

SEE PACKAGE INSERT FOR DOSAGE INFORMATION

USE AS DIRECTED BY PHYSICIAN

FOR INTRAPERITONEAL ADMINISTRATION ONLY

CAUTIONS SQUEEZE AND INSPECT INNER BAG

WHICH MAINTAINS PRODUCT STERILITY DISCARD

IF LEAKS ARE FOUND

DO NOT USE UNLESS SOLUTION IS CLEAR

DISCARD UNUSED PORTION

Rx ONLY

STORE UNIT IN MOISTURE BARRIER OVERWRAP AT

ROOM TEMPERATURE (25°C/77°F) UNTIL READY TO

USE

AVOID EXCESSIVE HEAT SEE INSERT

Ambu-Flex II CONTAINER PL 146 PLASTIC

BAXTER DIANEAL AMBU-FLEX II AND PL 146 ARE

TRADEMARKS OF BAXTER INTERNATIONAL INC

BAXTER HEALTHCARE CORPORATION

DEERFIELD IL 60015 USA

MADE IN USA

Carton Label

L5B4825

6-2000 ML

AMBU-FLEXTM II CONTAINERS

1.5%

DIANEAL LOW CALCIUM 1.5% DEX

PERITONEAL DIALYSIS SOLUTION

EXP

XXXXX

SECONDARY BAR CODE

(17) YYMM00 (10) XXXXX

PRIMARY BAR CODE

(01) 50309410409065

LOT

XXXXX

Dianeal Low Calcium Peritoneal Dialysis Solution WITH DEXTROSE
sodium chloride, sodium lactate, calcium chloride, magnesium chloride and dextrose injection, solution

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	NDC Product Code (Source)	0941-0409
Route of Administration	INTRAPERITONEAL	DEA Schedule

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
DEXTROSE (DEXTROSE)	DEXTROSE	1.5 g in 100 mL
SODIUM CHLORIDE (SODIUM CATION)	SODIUM CHLORIDE	538 mg in 100 mL
SODIUM LACTATE (SODIUM CATION)	SODIUM LACTATE	448 mg in 100 mL
CALCIUM CHLORIDE (CALCIUM CATION)	CALCIUM CHLORIDE	18.3 mg in 100 mL
MAGNESIUM CHLORIDE (MAGNESIUM CATION)	MAGNESIUM CHLORIDE	5.08 mg in 100 mL

Inactive Ingredients
Ingredient Name	Strength
WATER

Product Characteristics
Color		Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	NDC	Package Description	Multilevel Packaging
1	0941-0409-45	1500 mL In 1 BAG	None
2	0941-0409-36	2000 mL In 1 BAG	None
3	0941-0409-48	2500 mL In 1 BAG	None
4	0941-0409-49	3000 mL In 1 BAG	None
5	0941-0409-27	5000 mL In 1 BAG	None
6	0941-0409-28	6000 mL In 1 BAG	None
7	0941-0409-06	2000 mL In 1 BAG	None
8	0941-0409-07	5000 mL In 1 BAG	None
9	0941-0409-01	6000 mL In 1 BAG	None
10	0941-0409-05	3000 mL In 1 BAG	None

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
NDA	NDA017512	05/13/2010

Dianeal Low Calcium Peritoneal Dialysis Solution WITH DEXTROSE
sodium chloride, sodium lactate, calcium chloride, magnesium chloride and dextrose injection, solution

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	NDC Product Code (Source)	0941-0457
Route of Administration	INTRAPERITONEAL	DEA Schedule

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
DEXTROSE (DEXTROSE)	DEXTROSE	2.5 g in 100 mL
SODIUM CHLORIDE (SODIUM CATION)	SODIUM CHLORIDE	538 mg in 100 mL
SODIUM LACTATE (SODIUM CATION)	SODIUM LACTATE	448 mg in 100 mL
CALCIUM CHLORIDE (CALCIUM CATION)	CALCIUM CHLORIDE	18.3 mg in 100 mL
MAGNESIUM CHLORIDE (MAGNESIUM CATION)	MAGNESIUM CHLORIDE	5.08 mg in 100 mL

Inactive Ingredients
Ingredient Name	Strength
WATER

Product Characteristics
Color		Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	NDC	Package Description	Multilevel Packaging
1	0941-0457-45	1500 mL In 1 BAG	None
2	0941-0457-47	2000 mL In 1 BAG	None
3	0941-0457-48	2500 mL In 1 BAG	None
4	0941-0457-49	3000 mL In 1 BAG	None
5	0941-0457-25	5000 mL In 1 BAG

Thursday, July 1, 2010

boric acid ophthalmic

Generic Name: boric acid (ophthalmic) (BOR ik AS id off THAL mik)

Brand Names: Collyrium Fresh

What is boric acid ophthalmic?

Boric acid has mild antibiotic properties against fungal or bacterial infection.

Boric acid ophthalmic (for the eyes) is used as an eye wash to cleanse or irrigate the eyes. Boric acid provides soothing relief from eye irritation, and helps remove pollutants from the eye such as smog, chlorine, or other chemicals.

Boric acid ophthalmic may also be used for other purposes not listed in this medication guide.

What is the most important information I should know about boric acid ophthalmic?

You should not use this medication if you are allergic to boric acid.

Avoid using this medication if you have any open wound or other skin injury around your eyes.

Boric acid ophthalmic is for use only in the eyes. Do not allow the medicine to get in your mouth, nose, or ears. Avoid getting this medication on any skin wound or abrasion. Do not use boric acid ophthalmic while you are wearing contact lenses. This medication may contain a preservative that can be absorbed by soft contact lenses and cause discoloration. Wait at least 15 minutes after using boric acid ophthalmic before putting your contact lenses in. Call your doctor at once if you have a serious side effect such as severe burning or stinging of your eyes, severe eye pain, vision changes that last for several hours after use, or if your eye condition does not improve or if it gets worse after using boric acid.

Boric acid is a weak antibiotic and should not be used to treat any type of infection without the advice of a doctor. There are many other, more effective antibiotics available.

What should I discuss with my health care provider before taking boric acid ophthalmic?

You should not use this medication if you are allergic to boric acid.

Avoid using this medication if you have any open wound or other skin injury around your eyes.

Boric acid is a weak antibiotic and should not be used to treat any type of infection without the advice of a doctor. There are many other, more effective antibiotics available. Before using this medication, tell your doctor if you are pregnant or breast-feeding.

How should I take boric acid ophthalmic?

Use this medication as directed on the label, or as your doctor has prescribed. Do not use the medication in larger amounts or for longer than recommended.

Boric acid is usually given using an eye cup.

Use only a clean or sterile eye cup. Avoid touching the rim of the eye cup with your fingers while you are using it.

It may be best to use this medicine while standing over a sink or eye wash fountain.

Fill the eye cup about half way with boric acid ophthalmic solution. Bend your head forward and bring the cup to your eye. Press it tightly to your face around the eye. Then tilt your head back and open your eye wide.

Move the eye around in all directions to allow the boric acid to cleanse the eyeball thoroughly.

While still pressing the cup to your eye, bend forward over a sink. Remove the eye cup from your face and empty it into the sink. Allow any remaining boric acid solution to drain from your eye into the sink.

Repeat this procedure with your other eye if needed.

After using this medication, pat the skin dry around your eye using a clean tissue or towel. Do not rub your eyelids with the tissue or towel, or apply it directly to your eye.

Store boric acid ophthalmic at room temperature away from moisture and heat.

Keep boric acid ophthalmic solution in its sealed container until you are ready to use it.

What happens if I miss a dose?

Since boric acid ophthalmic is used only when needed, you are not likely to be on a dosing schedule. If your condition does not improve after using boric acid ophthalmic, ask your doctor before using a second dose of this medication.

What happens if I overdose?

Seek emergency medical attention if you think you have used too much of this medicine.

An overdose of boric acid ophthalmic is not likely to cause life-threatening symptoms.

What should I avoid while taking boric acid ophthalmic?

Do not use boric acid ophthalmic while you are wearing contact lenses. This medication may contain a preservative that can be absorbed by soft contact lenses and cause discoloration. Wait at least 15 minutes after using boric acid ophthalmic before putting your contact lenses in. Boric acid ophthalmic is for use only in the eyes. Do not allow the medicine to get in your mouth, nose, or ears. Avoid getting this medication on any skin wound or abrasion.

Boric acid ophthalmic 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. Call your doctor at once if you have a serious side effect such as:

severe burning or stinging of your eyes;

severe eye pain;

vision changes that last for several hours after use; or

if your eye condition does not improve or if it gets worse after using boric acid.

Less serious side effects may include:

mild stinging or eye irritation;

blurred vision;

watery eyes; or

eye redness.

This is not a complete list of side effects and others may occur. Tell your doctor about any unusual or bothersome side effect. You may report side effects to FDA at 1-800-FDA-1088.

What other drugs will affect boric acid ophthalmic?

Avoid using boric acid together with a contact lens wetting solution, or any other ophthalmic solution that contains polyvinyl alcohol.

It is not likely that other drugs you take orally or inject will have an effect on boric acid applied to the eyes. But many drugs can interact with each other. Tell your doctor about all your prescription and over-the-counter medications, vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start a new medication without telling your doctor.

More boric acid resources

Boric acid Support Group
0 Reviews for Boric acid - Add your own review/rating

Compare boric acid with other medications

Eye Dryness/Redness

Where can I get more information?

Your pharmacist can provide more information about boric acid ophthalmic.