Saturday, December 3, 2011

D-Feda II


Generic Name: guaifenesin and pseudoephedrine (gwye FEN e sin, SOO doe ee FED rin)

Brand Names: Altarussin PE, Ambifed, Ambifed-G, Biotuss PE, Congestac, D-Feda II, Despec-SR, Dynex, Entex PSE, ExeFen, ExeFen-IR, Guiatex II SR, Levall G, Maxifed, Maxifed-G, Medent LD, Medent-LDI, Mucinex D, Mucinex D Max Strength, Nasabid SR, Nasatab LA, Nomuc-PE, Poly-Vent, Poly-Vent IR, Poly-Vent, Jr., Pseudatex, Pseudo GG, Pseudo GG TR, Pseudo Max, Q-Tussin PE, Respaire-120 SR, Respaire-30, Respaire-60 SR, Robitussin PE, Robitussin Severe Congestion, Ru-Tuss Jr., Sinutab Non Drying, Stamoist E, SudaTex-G, Tenar PSE, Touro LA, Touro LA-LD, Triaminic Softchews Chest Congestion, We Mist II LA, We Mist LA


What is D-Feda II (guaifenesin and pseudoephedrine)?

Guaifenesin is an expectorant. It helps loosen congestion in your chest and throat, making it easier to cough out through your mouth.


Pseudoephedrine is a decongestant that shrinks blood vessels in the nasal passages. Dilated blood vessels can cause nasal congestion (stuffy nose).


The combination of guaifenesin and pseudoephedrine is used to treat stuffy nose, sinus congestion, and cough caused by allergies or the common cold.


Guaifenesin and pseudoephedrine may also be used for purposes not listed in this medication guide.


What is the most important information I should know about D-Feda II (guaifenesin and pseudoephedrine)?


Do not give this medication to a child younger than 4 years old. Alwayss ask a doctor before giving a cough or cold medicine to a child. Death can occur from the misuse of cough and cold medicines in very young children. Do not use a cough or cold medicine if you have used an MAO inhibitor such as furazolidone (Furoxone), isocarboxazid (Marplan), phenelzine (Nardil), rasagiline (Azilect), selegiline (Eldepryl, Emsam, Zelapar), or tranylcypromine (Parnate) in the last 14 days. A dangerous drug interaction could occur, leading to serious side effects. Ask a doctor or pharmacist before using any other cold, cough, or allergy medicine. Guaifenesin and pseudoephedrine are contained in many combination medicines. Taking certain products together can cause you to get too much of a certain drug. Check the label to see if a medicine contains guaifenesin or pseudoephedrine.

What should I discuss with my healthcare provider before taking D-Feda II (guaifenesin and pseudoephedrine)?


You should not use this medication if you are allergic to guaifenesin or pseudoephedrine, or to other decongestants, diet pills, stimulants, or ADHD medications. Do not use a cough or cold medicine if you have used an MAO inhibitor such as furazolidone (Furoxone), isocarboxazid (Marplan), phenelzine (Nardil), rasagiline (Azilect), selegiline (Eldepryl, Emsam, Zelapar), or tranylcypromine (Parnate) in the last 14 days. A dangerous drug interaction could occur, leading to serious side effects.

Ask a doctor or pharmacist if it is safe for you to take this medicine if you have:



  • heart disease or high blood pressure;




  • diabetes; or




  • a thyroid disorder.




It is not known whether guaifenesin and pseudoephedrine will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant while using this medication. Guaifenesin and pseudoephedrine may pass into breast milk and may harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby.

Artificially sweetened liquid cough or cold medicine may contain phenylalanine. If you have phenylketonuria (PKU), check the medication label to see if the product contains phenylalanine.


How should I take D-Feda II (guaifenesin and pseudoephedrine)?


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. Cough and cold medicine is usually taken only for a short time until your symptoms clear up.


Do not give this medication to a child younger than 4 years old. Always ask a doctor before giving a cough or cold medicine to a child. Death can occur from the misuse of cough and cold medicines in very young children. Do not crush, chew, break, or open an extended-release tablet or capsule. Swallow it whole. Breaking or opening the pill may cause too much of the drug to be released at one time.

Measure liquid medicine with a special dose-measuring spoon or medicine cup, not with a regular table spoon. If you do not have a dose-measuring device, ask your pharmacist for one.


Drink extra fluids to help loosen the congestion and lubricate your throat while you are taking this medication. Take with food if this medicine upsets your stomach. Do not take guaifenesin and pseudoephedrine for longer than 7 days in a row. Talk with your doctor if your symptoms do not improve after 7 days of treatment, or if you have a fever with a headache, cough, or skin rash.

If you need surgery, tell the surgeon ahead of time if you have taken a cough or cold medicine within the past few days.


Store at room temperature away from moisture, heat, and light.

What happens if I miss a dose?


Since cough or cold medicine is taken when needed, you may not be on a dosing schedule. If you are taking the medication regularly, 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?


Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Overdose symptoms may include nausea, vomiting, dizziness, and feeling restless or nervous.


What should I avoid while taking D-Feda II (guaifenesin and pseudoephedrine)?


This medication may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be alert. Drinking alcohol can increase certain side effects of guaifenesin and pseudoephedrine.

Avoid taking this medication if you also take diet pills, caffeine pills, or other stimulants (such as ADHD medications). Taking a stimulant together with a decongestant can increase your risk of unpleasant side effects.


Ask a doctor or pharmacist before using any other cold, cough, or allergy medicine. Guaifenesin and pseudoephedrine are contained in many combination medicines. Taking certain products together can cause you to get too much of a certain drug. Check the label to see if a medicine contains guaifenesin or pseudoephedrine.

D-Feda II (guaifenesin and pseudoephedrine) side effects


Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat. Stop using this medication and call your doctor at once if you have a serious side effect such as:

  • fast, pounding, or uneven heartbeat;




  • severe dizziness, anxiety, or nervousness;




  • easy bruising or bleeding, unusual weakness, fever, chills, body aches, flu symptoms; or




  • increased blood pressure (severe headache, blurred vision, trouble concentrating, chest pain, numbness, seizure).



Less serious side effects may include:



  • dizziness or headache;




  • feeling restless or excited;




  • sleep problems (insomnia);




  • mild nausea, vomiting, or stomach upset;




  • mild loss of appetite;




  • warmth, redness, or tingly feeling under your skin; or




  • skin rash or itching.



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 D-Feda II (guaifenesin and pseudoephedrine)?


Tell your doctor about all other medicines you use, especially:



  • methyldopa (Aldomet);




  • blood pressure medications;




  • a beta-blocker such as atenolol (Tenormin, Tenoretic), carvedilol (Coreg), labetalol (Normodyne, Trandate), metoprolol (Lopressor, Toprol), nadolol (Corgard), propranolol (Inderal, InnoPran), sotalol (Betapace), and others; or




  • an antidepressant such as amitriptyline (Elavil), clomipramine (Anafranil), imipramine (Janimine, Tofranil), and others.



This list is not complete and other drugs may interact with guaifenesin and pseudoephedrine. 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 D-Feda II resources


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


  • Congestac MedFacts Consumer Leaflet (Wolters Kluwer)

  • Entex PSE Controlled-Release Capsules MedFacts Consumer Leaflet (Wolters Kluwer)

  • Mucinex D Prescribing Information (FDA)

  • Mucinex D Consumer Overview

  • Pseudovent Consumer Overview

  • Robitussin Severe Congestion MedFacts Consumer Leaflet (Wolters Kluwer)

  • Zephrex LA Sustained-Release Tablets MedFacts Consumer Leaflet (Wolters Kluwer)



Compare D-Feda II with other medications


  • Cough and Nasal Congestion


Where can I get more information?


  • Your pharmacist can provide more information about guaifenesin and pseudoephedrine.

See also: D-Feda II side effects (in more detail)



Wednesday, August 3, 2011

Dianeal PD-2





Dosage Form: injection, solution
Dianeal PD-2 Peritoneal Dialysis Solution

AMBU-FLEX Container For Peritoneal Dialysis

For intraperitoneal administration only

Dianeal PD-2 Description


Dianeal PD-2 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 DIANEAL 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.


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 this formulation has been raised to 40 mEq/L. Serum bicarbonate levels should be monitored.


The osmolarities shown in Table 1 are calculated values. As an example, measured osmolarity by freezing point depression determination of Dianeal PD-2 peritoneal dialysis solution with 1.5% dextrose is approximately 334 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 overwrap 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 PD-2 - 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 to attempt to normalize plasma electrolyte concentrations resulting from osmosis and diffusion across the peritoneal membrane (between the plasma of the patient 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 PD-2


Peritoneal dialysis is indicated for patients in acute or chronic renal failure when nondialytic medical therapy is judged to be inadequate (Vaamonde and Perez 1977). It may also be indicated in the treatment of certain fluid and electrolyte disturbances, and for patients intoxicated with certain poisons and drugs (Knepshield et al. 1977). However, for many substances other methods of detoxification have been reported to be more effective than peritoneal dialysis (Vaamonde and Perez 1977; Chang 1977).



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 PD-2 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.


In acute renal failure patients, plasma electrolyte concentrations should be monitored periodically during the procedure. 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.


Because average plasma magnesium levels in 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 this formulation has been raised to 40 mEq/L. Serum bicarbonate levels should be monitored.


Not for use in the treatment of lactic acidosis.


Potassium is omitted from Dianeal PD-2 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 overwrap, 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). Do not flex or manipulate container when frozen. Allow container 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 peritoneal dialysis solutions. It is also not known whether DIANEAL peritoneal dialysis solutions can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. DIANEAL 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.



Dianeal PD-2 Dosage and Administration


Dianeal PD-2 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 judgement 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, 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 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 chronic 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 PD-2 Supplied


Dianeal PD-2 peritoneal dialysis solutions in AMBU-FLEX II and AMBU-FLEX III containers are available in nominal size flexible containers with fill volumes and dextrose concentrations as indicated in Table 1.


All Dianeal PD-2 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.


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.



To Open


Tear overwrap 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.


  1. Put on mask. Clean and/or disinfect hands.

  2. Prepare medication site using aseptic technique.

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

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

  5. Mix solution and medication thoroughly.


Preparation for Administration


  1. Put on mask. Clean and/or disinfect hands.

  2. Place solution container on work surface.

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

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

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

  6. Upon completion of therapy, discard unused portion.


REFERENCES


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

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

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

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

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

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

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

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

  9. 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.

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

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

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

  13. 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.

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

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

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














































































































































Table 1.
Composition/

100 mL
Osmolarity

(mOsmol/L) (calc)
pHIonic Concentration

(mEq/L)
How Supplied
*Dextrose, Hydrous, USPSodium Chloride,USP (NaCl)Sodium Lactate

(C3H5NaO3)
Calcium Chloride, USP

(CaCl2•2H2O)
Magnesium Chloride, USP

(MgCl2•6H2O)
SodiumCalciumMagnesiumChlorideLactateFill

Volume

(mL)
Container

Size

(mL)
CodeNDC
Dianeal PD-2 Peritoneal Dialysis Solution with 1.5% Dextrose

AMBU-FLEX II CONTAINER
1.5g538 mg448 mg25.7 mg5.08 mg3465.2

(4.0 to 6.5)
1323.50.596401000

2000

2500

3000

5000

6000
1000

3000

3000

3000

6000

6000
L5B5163

L5B5166

L5B5168

L5B5169

L5B5193

L5B9710
NDC 0941-0411-05

NDC 0941-0411-06

NDC 0941-0411-08

NDC 0941-0411-04

NDC 0941-0411-07

NDC 0941-0411-11
Dianeal PD-2 Peritoneal Dialysis Solution with 1.5% Dextrose

AMBU-FLEX III CONTAINER
1.5 g538 mg448 mg25.7 mg5.08 mg3465.2

(4.0 to 6.5)
1323.50.59640250

500

750

1000

1500

2000

2500

3000

5000

6000
500

1000

1000

1000

2000

2000

3000

3000

5000

6000
5B5160

5B5161

5B5162

5B5163

5B5165

5B5166

5B5168

5B5169

5B5193

5B9710
NDC 0941‑0411‑40

NDC 0941-0411-41

NDC 0941-0411-42

NDC 0941-0411-43

NDC 0941-0411-45

NDC 0941-0411-46

NDC 0941-0411-48

NDC 0941-0411-49

NDC 0941-0411-25

NDC 0941-0411-28
Dianeal PD-2 Peritoneal Dialysis Solution with 2.5% Dextrose

AMBU-FLEX II CONTAINER
2.5 g538 mg448 mg25.7 mg5.08 mg3965.2

(4.0 to 6.5)
1323.50.596401000

2000

2500

3000

5000

6000
1000

3000

3000

3000

6000

6000
L5B5173

L5B5177

L5B5178

L5B5179

L5B5194

L5B9711
NDC 0941-0413-05

NDC 0941-0413-06

NDC 0941-0413-08

NDC 0941-0413-04

NDC 0941-0413-07

NDC 0941-0413-01
Dianeal PD-2 Peritoneal Dialysis Solution with 2.5% Dextrose

AMBU-FLEX III CONTAINER
2.5 g538 mg448 mg25.7 mg5.08 mg3965.2

(4.0 to 6.5)
1323.50.59640250

500

750

1000

1000

1500

2000

2500

3000

5000

6000
500

1000

1000

1000

2000

2000

3000

3000

3000

5000

6000
5B5170

5B5171

5B5172

5B5173

5B5174

5B5175

5B5177

5B5178

5B5179

5B5194

5B9711
NDC 0941-0413-40

NDC 0941-0413-41

NDC 0941-0413-42

NDC 0941-0413-43

NDC 0941-0413-44

NDC 0941-0413-45

NDC 0941-0413-47

NDC 0941-0413-48

NDC 0941-0413-49

NDC 0941-0413-25

NDC 0941-0413-28
Dianeal PD-2 Peritoneal Dialysis Solution with 3.5% Dextrose3.5 g538 mg448 mg25.7 mg5.08 mg4475.2

(4.0 to 6.5)
1323.50.59640250030005B4804NDC 0941‑0423‑48
Dianeal PD-2 Peritoneal Dialysis Solution with 4.25% Dextrose

AMBU-FLEX II CONTAINER
4.25 g538 mg448 mg25.7 mg5.08 mg4855.2

(4.0 to 6.5)
1323.50.596401000

2000

2500

3000

5000

6000
1000

3000

3000

3000

6000

6000
L5B5183

L5B5187

L5B5188

L5B5189

L5B5195

L5B9712
NDC 0941-0415-05

NDC 0941-0415-06

NDC 0941-0415-08

NDC 0941-0415-04

NDC 0941-0415-07

NDC 0941-0415-01
Dianeal PD-2 Peritoneal Dialysis Solution with 4.25% Dextrose

AMBU-FLEX III CONTAINER
4.25 g538 mg448 mg25.7 mg5.08 mg4855.2

(4.0 to 6.5)
1323.50.59640250

500

750

1000

1000

1500

2000

2500

3000

5000

6000
500

1000

1000

1000

2000

2000

3000

3000

3000

5000

6000
5B5180

5B5181

5B5182

5B5183

5B5184

5B5185

5B5187

5B5188

5B5189

5B5195

5B9712
NDC 0941‑0415‑40

NDC 0941-0415-41

NDC 0941-0415-42

NDC 0941-0415-43

NDC 0941-0415-44

NDC 0941-0415-45

NDC 0941-0415-47

NDC 0941-0415-48

NDC 0941-0415-49

NDC 0941-0415-25

NDC 0941-0415-28


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


Baxter Healthcare Corporation


Deerfield, IL 60015 USA


Printed in USA


©Copyright 1981, 1982, 1983, 1984, 1989, 2008


Baxter Healthcare Corporation.


All rights reserved.


07-19-59-178


2008/11



PACKAGE LABEL - PRINCIPAL DISPLAY PANEL


Container Label



L5B5169

NDC 0941-0411-04


 3000 mL

(APPROX 100 mL EXCESS)


Baxter


Dianeal PD-2

Peritoneal Dialysis Solution

with 1.5% Dextrose


EACH 100 mL CONTAINS 1.5 g DEXTROSE HYDROUS USP

538 mg SODIUM CHLORIDE USP 448 mg SODIUM LACTATE

25.7 mg CALCIUM CHLORIDE USP 5.08 mg MAGNESIUM

CHLORIDE USP pH 5.2 (4.0 TO 6.5)


mEq/L SODIUM - 132 CALCIUM - 3.5 MAGNESIUM - 0.5

CHLORIDE - 96 LACTATE - 40

OSMOLARITY - 346 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






PD-21.5% Dextrose

Carton Label



L5B5169

4-3000 ML

AMBU-FLEX II CONTAINERS


1.5%


Dianeal PD-2 1.5% DEX

PERITONEAL DIALYSIS SOLUTION


EXP

XXXXX


SECONDARY BAR CODE


(17) YYMM00 (10) XXXXX


PRIMARY BAR CODE


(01) 50309410411044


LOT

XXXXX









Dianeal PD-2 PERITONEAL DIALYSIS SOLUTION WITH DEXTROSE 
dextrose, sodium chloride, sodium lactate, calcium chloride, and magnesium chloride  injection, solution










Product Information
Product TypeHUMAN PRESCRIPTION DRUGNDC Product Code (Source)0941-0411
Route of AdministrationINTRAPERITONEALDEA Schedule    




















Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DEXTROSE (DEXTROSE)DEXTROSE1.5 g  in 100 mL
SODIUM CHLORIDE (SODIUM CATION)SODIUM CHLORIDE538 mg  in 100 mL
SODIUM LACTATE (SODIUM CATION)SODIUM LACTATE448 mg  in 100 mL
CALCIUM CHLORIDE (CALCIUM CATION)CALCIUM CHLORIDE25.7 mg  in 100 mL
MAGNESIUM CHLORIDE (MAGNESIUM CATION)MAGNESIUM CHLORIDE5.08 mg  in 100 mL






Inactive Ingredients
Ingredient NameStrength
WATER 


















Product Characteristics
Color    Score    
ShapeSize
FlavorImprint Code
Contains      


































































Packaging
#NDCPackage DescriptionMultilevel Packaging
10941-0411-051000 mL In 1 BAGNone
20941-0411-062000 mL In 1 BAGNone
30941-0411-075000 mL In 1 BAGNone
40941-0411-40250 mL In 1 BAGNone
50941-0411-41500 mL In 1 BAGNone
60941-0411-42750 mL In 1 BAGNone
70941-0411-431000 mL In 1 BAGNone
80941-0411-451500 mL In 1 BAGNone
90941-0411-462000 mL In 1 BAGNone
100941-0411-482500 mL In 1 BAGNone
110941-0411-493000 mL In 1 BAGNone
120941-0411-255000 mL In 1 BAGNone
130941-0411-286000 mL In 1 BAGNone
140941-0411-116000 mL In 1 BAGNone
150941-0411-043000 mL In 1 BAGNone










Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
NDANDA01751206/17/2010






Dianeal PD-2 PERITONEAL DIALYSIS SOLUTION WITH DEXTROSE 
dextrose, sodium chloride, sodium lactate, calcium chloride, and magnesium chloride  injection, solution










Product Information
Product TypeHUMAN PRESCRIPTION DRUGNDC Product Code (Source)0941-0413
Route of AdministrationINTRAPERITONEALDEA Schedule    




















Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DEXTROSE (DEXTROSE)DEXTROSE2.5 g  in 100 mL
SODIUM CHLORIDE (SODIUM CATION)SODIUM CHLORIDE538 mg  in 100 mL
SODIUM LACTATE (SODIUM CATION)SODIUM LACTATE448 mg  in 100 mL
CALCIUM CHLORIDE (CALCIUM CATION)CALCIUM CHLORIDE25.7 mg  in 100 mL
MAGNESIUM CHLORIDE (MAGNESIUM CATION)MAGNESIUM CHLORIDE5.08 mg  in 100 mL






Inactive Ingredients
Ingredient NameStrength
WATER 


















Product Characteristics
Color    Score    
ShapeSize
FlavorImprint Code
Contains      














Packaging
#NDCPackage DescriptionMultilevel Packaging
10941-0413-051000 mL In 1 BAGNone
20941-0413-062000 mL In 1 BAGNone
3

Saturday, July 9, 2011

Diphenhydramine, hydrocodone, and phenylephrine


Generic Name: diphenhydramine, hydrocodone, and phenylephrine (dye fen HYE dra meen, hye droe KOE dohn, feh nill EH frin)

Brand names: Endal HD, Tussinate, Hydro-DP, Rindal HPD, Gestuss-HC, Dytan-HC, D-Tann HC


What is diphenhydramine, hydrocodone, and phenylephrine?

Diphenhydramine is an antihistamine. It blocks the effects of the naturally occurring chemical histamine in the body and reduces congestion.


Hydrocodone is a narcotic. It is a pain reliever and a cough suppressant.


Phenylephrine is a decongestant. It works by constricting (shrinking) blood vessels (veins and arteries) in the body. Constriction of blood vessels in the sinuses and nose decreases congestion.


Diphenhydramine, hydrocodone, and phenylephrine is used to treat cough and nasal congestion associated with upper respiratory tract infections and allergies.


Diphenhydramine, hydrocodone, and phenylephrine may also be used for purposes other than those listed in this medication guide.


What is the most important information I should know about diphenhydramine, hydrocodone, and phenylephrine?


Use caution when driving, operating machinery, or performing other hazardous activities. Diphenhydramine, hydrocodone, and phenylephrine may cause dizziness or drowsiness. If you experience dizziness or drowsiness, avoid these activities. Use alcohol cautiously. Alcohol may increase drowsiness and dizziness while taking diphenhydramine, hydrocodone, and phenylephrine.

Diphenhydramine, hydrocodone, and phenylephrine may increase the effects of other drugs that cause drowsiness, including antidepressants, alcohol, antihistamines, sedatives (used to treat insomnia), pain relievers, anxiety medicines, seizure medicines, and muscle relaxants. Tell your doctor about all medicines that you are taking, and do not take any other medicine without first talking to your doctor.


Hydrocodone is habit forming. It is possible become physically and/or psychologically dependent on the medication. Do not take more than the prescribed amount of medication or take it for longer than is directed by your doctor. Withdrawal effects may occur if diphenhydramine, hydrocodone, and phenylephrine is stopped suddenly after several weeks of continuous use. Your doctor may recommend a gradual reduction in dose.

What should I discuss with my healthcare provider before taking diphenhydramine, hydrocodone, and phenylephrine?


Do not take diphenhydramine, hydrocodone, and phenylephrine if you have taken a monoamine oxidase inhibitor (MAOI) such as isocarboxazid (Marplan), phenelzine (Nardil), or tranylcypromine (Parnate) in the last 14 days. A dangerous drug interaction could occur, leading to serious side effects.


Before taking diphenhydramine, hydrocodone, and phenylephrine, tell your doctor if you have



  • epilepsy or another seizure disorder;




  • been diagnosed with sleep apnea (periods of not breathing during sleep);




  • thyroid problems;




  • asthma;




  • gallbladder disease;




  • a head injury;




  • Addison's disease;




  • diabetes;




  • glaucoma;




  • an ulcer or an obstruction in the stomach;




  • bladder problems or difficulty urinating;



  • an enlarged prostate;


  • high blood pressure, irregular heartbeats, or any type of heart disease;



  • kidney problems; or

  • liver problems.

You may not be able to take diphenhydramine, hydrocodone, and phenylephrine, or you may require a dosage adjustment or special monitoring during treatment if you have any of the conditions listed above.


Diphenhydramine, hydrocodone, and phenylephrine is in the FDA pregnancy category C. This means that it is not known whether diphenhydramine, hydrocodone, and phenylephrine will be harmful to an unborn baby. Do not take diphenhydramine, hydrocodone, and phenylephrine without first talking to your doctor if you are pregnant or could become pregnant during treatment. It is not known whether diphenhydramine, hydrocodone, and phenylephrine passes into breast milk. Do not take diphenhydramine, hydrocodone, and phenylephrine without first talking to your doctor if you are breast-feeding a baby. If you are over 60 years of age, you may be more likely to experience side effects from diphenhydramine, hydrocodone, and phenylephrine. Your doctor may prescribe a lower dose of this medication.

How should I take diphenhydramine, hydrocodone, and phenylephrine?


Take diphenhydramine, hydrocodone, and phenylephrine exactly as directed by your doctor. If you do not understand the directions on your prescription bottle, ask your pharmacist, nurse, or doctor to explain the instructions to you.


Diphenhydramine, hydrocodone, and phenylephrine can be taken with or without food.


To ensure that you get a correct dose, measure the liquid form of diphenhydramine, hydrocodone, and phenylephrine with a special dose-measuring spoon or cup, not with a regular table spoon. If you do not have a dose-measuring device, ask your pharmacist where you can get one.


Store diphenhydramine, hydrocodone, and phenylephrine at room temperature away from moisture and heat.

See also: Diphenhydramine, hydrocodone, and phenylephrine dosage (in more detail)

What happens if I miss a dose?


Take the missed dose as soon as you remember. However, if it is almost time for the next dose, skip the missed dose and take only the next regularly scheduled dose. Do not take a double dose of this medication unless otherwise directed by your doctor.


What happens if I overdose?


Seek emergency medical attention if an overdose is suspected.

Symptoms of a diphenhydramine, hydrocodone, and phenylephrine overdose may include severe drowsiness, dizziness, headache, seizures, dry mouth, cold and clammy skin, flushing, nausea, vomiting, difficulty or decreased breathing, and unconsciousness.


What should I avoid while taking diphenhydramine, hydrocodone, and phenylephrine?


Use caution when driving, operating machinery, or performing other hazardous activities. Diphenhydramine, hydrocodone, and phenylephrine may cause dizziness or drowsiness. If you experience dizziness or drowsiness, avoid these activities. Use alcohol cautiously. Alcohol may increase drowsiness and dizziness while taking diphenhydramine, hydrocodone, and phenylephrine.

Diphenhydramine, hydrocodone, and phenylephrine may increase the effects of other drugs that cause drowsiness, including antidepressants, alcohol, antihistamines, sedatives (used to treat insomnia), pain relievers, anxiety medicines, seizure medicines, and muscle relaxants. Tell your doctor about all medicines that you are taking, and do not take any other medicine without first talking to your doctor.


Diphenhydramine, hydrocodone, and phenylephrine side effects


If you experience any of the following serious side effects, stop taking diphenhydramine, hydrocodone, and phenylephrine and seek emergency medical attention or contact your doctor immediately:

  • an allergic reaction (difficulty breathing; closing of the throat; swelling of the lips, tongue, or face; or hives); or




  • confusion, hallucinations, or unusual behavior.



Other, less serious side effects may be more likely to occur. Continue to take diphenhydramine, hydrocodone, and phenylephrine and talk to your doctor if you experience



  • dizziness, drowsiness, or sleepiness;




  • restlessness or irritability;




  • blurred vision;




  • constipation;




  • dry mouth, nausea, vomiting, or decreased appetite;




  • muscle twitches;




  • sweating;




  • itching;




  • decreased urination;




  • increased sensitivity to sunlight.




Hydrocodone is habit forming. It is possible become physically and/or psychologically dependent on the medication. Do not take more than the prescribed amount of medication or take it for longer than is directed by your doctor. Withdrawal effects may occur if diphenhydramine, hydrocodone, and phenylephrine is stopped suddenly after several weeks of continuous use. Your doctor may recommend a gradual reduction in dose.

Side effects other than those listed here may also occur. Talk to your doctor about any side effect that seems unusual or that is especially bothersome. You may report side effects to FDA at 1-800-FDA-1088.


Diphenhydramine, hydrocodone, and phenylephrine Dosing Information


Usual Adult Dose for Cough and Nasal Congestion:

Diphenhydramine/hydrocodone/phenylephrine 12.5 mg-2 mg-7.5 mg/5 mL:
10 mL orally every 4 hours not to exceed 40 mL daily.

Diphenhydramine/hydrocodone/phenylephrine 12.5 mg-3.5 mg-5 mg/5 mL:
10 mL orally every 4 to 6 hours not to exceed 40 mL daily.

Diphenhydramine/hydrocodone/phenylephrine 25 mg-3.5 mg-7.5 mg/5 mL:
5 mL to 10 mL orally every 12 hours.

Usual Pediatric Dose for Cough and Nasal Congestion:

Diphenhydramine/hydrocodone/phenylephrine 12.5 mg-2 mg-7.5 mg/5 mL:
>12 yrs: 10 mL orally every 4 hours not to exceed 40 mL daily.
6 yrs to >=12 yrs: 5 mL orally every 4 hours not to exceed 20 mL daily.

Diphenhydramine/hydrocodone/phenylephrine 12.5 mg-3.5 mg-5 mg/5 mL:
>12 yrs: 10 mL orally every 4 to 6 hours not to exceed 40 mL daily.
6 yrs to >=12 yrs: 5 mL orally every 4 to 6 hours not to exceed 20 mL daily.

Diphenhydramine/hydrocodone/phenylephrine 25 mg-3.5 mg-7.5 mg/5 mL:
>12 yrs: 5 mL to 10 mL orally every 12 hours
6 yrs to >=12 yrs: 2.5 mL to 5 mL orally every 12 hours


What other drugs will affect diphenhydramine, hydrocodone, and phenylephrine?


Do not take diphenhydramine, hydrocodone, and phenylephrine if you have taken a monoamine oxidase inhibitor (MAOI) such as isocarboxazid (Marplan), phenelzine (Nardil), or tranylcypromine (Parnate) in the last 14 days. A dangerous drug interaction could occur, leading to serious side effects.


Diphenhydramine, hydrocodone, and phenylephrine may increase the effects of other drugs that cause drowsiness, including antidepressants, alcohol, sedatives (used to treat insomnia), pain relievers, anxiety medicines, and muscle relaxants. Tell your doctor about all medicines that you are taking, and do not take any medicine without first talking to your doctor.


Drugs other than those listed here may also interact with diphenhydramine, hydrocodone, and phenylephrine. Talk to your doctor and pharmacist before taking any prescription or over-the-counter medicines, including vitamins, minerals, and herbal products.



More diphenhydramine, hydrocodone, and phenylephrine resources


  • Diphenhydramine, hydrocodone, and phenylephrine Side Effects (in more detail)
  • Diphenhydramine, hydrocodone, and phenylephrine Dosage
  • Diphenhydramine, hydrocodone, and phenylephrine Use in Pregnancy & Breastfeeding
  • Diphenhydramine, hydrocodone, and phenylephrine Drug Interactions
  • Diphenhydramine, hydrocodone, and phenylephrine Support Group
  • 0 Reviews for Diphenhydramine, hydrocodone, and phenylephrine - Add your own review/rating


Compare diphenhydramine, hydrocodone, and phenylephrine with other medications


  • Cough and Nasal Congestion


Where can I get more information?


  • Your pharmacist has more information about diphenhydramine, hydrocodone, and phenylephrine written for health professionals that you may read.

See also: diphenhydramine, hydrocodone, and phenylephrine side effects (in more detail)