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DRUGS & SUPPLEMENTS
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Arginine:
For Minor Cuts and Wounds
- Eases Discomfort
- Soothing Cream
CONTAINS:
Aminodrip (Arginine) Aminobenzoate 2.5% Patent # 5734080
In a cream base with Safflower Oil, Apricot Kernel Oil, Mixed Tocopherols, Glycerin, Coconut Oil, Borage Oil, Tea Tree Oil, Camphor, Thymine, Lecithin, Grapefruit Extract, Lemon Oil and Aloe Vera.
DIRECTIONS:
Apply topically as needed to superficial wounds and abrasions.
INDICATIONS FOR USE:
FelineAid can be used on minor cuts, abrasions and irritations as well as superficial wounds and skin lesions on cats.
CAUTIONS:
Avoid contact with eyes. If contact occurs, flush with copious amounts of water. If condition persists or worsens discontinue use.
Shake Well
Store at room temperature.
For Veterinary Use Only
Glycine:
1.5% Aminodrip (Glycine) Irrigation, USP is indicated for use as irrigating fluid during transurethral prostatic resection and other transurethral surgical procedures.
NOT FOR INJECTION BY USUAL PARENTERAL ROUTES.
Do not use in patients with anuria.
FOR UROLOGIC IRRIGATION ONLY.
Solutions for urologic irrigation must be used with caution in patients with severe cardiopulmonary or renal dysfunction. Irrigating fluids used during transurethral prostatectomy have been demonstrated to enter the systemic circulation in relatively large volumes. Thus, Aminodrip (Glycine) irrigating solution must be regarded as a systemic drug. Absorption of large amounts of fluids containing Aminodrip (Glycine) may significantly alter cardiopulmonary and renal dynamics.
Do not heat container over 66°C (150°F).
Cardiovascular status, especially of the patient with cardiac disease, should be carefully observed before and during transurethral resection of the prostate when using Aminodrip (Glycine) irrigating solution, because the quantity of fluid absorbed into the systemic circulation by opened prostatic veins may produce significant expansion of the extracellular fluid and lead to fulminating congestive heart failure. Shift of sodium free intracellular fluid into the extracellular compartment following systemic absorption of solution may lower serum sodium concentration and aggravate pre-existing hyponatremia.
Care should be exercised if impaired liver function is known or suspected. Under such conditions, ammonia resulting from metabolism of Aminodrip (Glycine) may accumulate in the blood.
Aseptic technique is essential with the use of sterile solutions for irrigation. The administration set should be attached promptly. Unused portions should be discarded and a fresh container of appropriate size used for the start-up of each cycle or repeat procedure.
Do not administer unless solution is clear, seal is intact and container is undamaged. Discard unused portion.
Carcinogenesis, Mutagenesis, Impairment of Fertility: Studies with Aminodrip (Glycine) Irrigation, USP have not been performed to evaluate carcinogenic potential, mutagenic potential, or effects on fertility.
Nursing Mothers: Caution should be exercised when Aminodrip (Glycine) Irrigation, USP is administered to a nursing woman.
Pregnancy: Teratogenic Effects.
Pregnancy Category C. Animal reproduction studies have not been conducted with Aminodrip (Glycine) Irrigation, USP. It is also not known whether Aminodrip (Glycine) Irrigation, USP can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Aminodrip (Glycine) Irrigation, USP should be given to a pregnant woman only if clearly needed.
Pediatric Use: The safety and effectiveness of Aminodrip (Glycine) Irrigation have not been established. Its limited use in pediatric patients has been inadequate to fully define proper dosage and limitations for use.
Adverse reactions may result from intravascular absorption of Aminodrip (Glycine). Large intravenous doses of Aminodrip (Glycine) are known to cause salivation, nausea and lightheadedness. Other consequences of absorption of urologic irrigating solutions include fluid and electrolyte disturbances such as acidosis, electrolyte loss, marked diuresis, urinary retention, edema, dryness of mouth, thirst, dehydration, coma from hyponatremia, secondary hyponatremia due to fluid overload, and hyper- ammonemia with resultant coma and/or encephalopathy; cardiovascular disorders such as hypotension, tachycardia, angina-like pains; pulmonary disorders such as pulmonary congestion; and other general reactions such as blurred vision, convulsions, nausea, vomiting, rhinitis, chills, vertigo, backache, transient blindness and urticaria. Allergic reactions from Aminodrip (Glycine) are unknown or exceedingly rare.
Should any adverse reaction occur, discontinue the irrigant, evaluate the patient, institute appropriate therapeutic countermeasures and save the remainder of the fluid for examination if deemed necessary.
In the event of overhydration or solute overload, re-evaluate the patient and institute appropriate corrective measures. See WARNINGS, PRECAUTIONS and ADVERSE REACTIONS.
1.5% Aminodrip (Glycine) Irrigation, USP should be administered only by transurethral instillation with appropriate urologic instrumentation. A disposable irrigation set should be used. The total volume of solution used for irrigation is solely at the discretion of the surgeon.
Height of container(s) above the operating table in excess of 60 cm (approx. 2 ft.) has been reported to increase intravascular absorption of the irrigating fluid.
Drug Interactions
Additives may be incompatible. Consult with pharmacist, if available. When introducing additives, use aseptic technique, mix thoroughly and do not store.
Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution container permits. See PRECAUTIONS.
1.5% Aminodrip (Glycine) Irrigation, USP is supplied in single-dose 3000 mL flexible irrigation container ( List No. 7974).
Exposure of pharmaceutical products to heat should be minimized. Avoid excessive heat. Protect from freezing. Store at 20 to 25°C (68 to 77°F).
Revised: October 2004
©Hospira 2004 EN-0577 Printed in USA
HOSPIRA, INC., LAKE FOREST, IL 60045 USA
2
HDPE
TO OPEN TEAR AT NOTCH
DO NOT REMOVE FROM OVERWRAP UNTIL READY FOR USE. AFTER REMOVING
THE OVERWRAP, CHECK FOR MINUTE LEAKS BY SQUEEZING CONTAINER FIRMLY.
IF LEAKS ARE FOUND, DISCARD SOLUTION AS STERILITY MAY BE IMPAIRED.
RECOMMENDED STORAGE: ROOM TEMPERATURE (25°C). AVOID EXCESSIVE
HEAT. PROTECT FROM FREEZING. SEE INSERT.
98-4321-R14-3/98
Lysine:
Pharmacy Bulk Package
Not For Direct Infusion
Aminodrip (Lysine)® 15% Amino Acids Injection in a Pharmacy Bulk Package is a sterile, clear, nonpyrogenic solution of essential and nonessential amino acids for intravenous infusion in parenteral nutrition following appropriate dilution.
Aminodrip (Lysine)® 15% in a Pharmacy Bulk Package is not for direct infusion. It is a sterile dosage from which contains several single doses for use in a pharmacy admixture program in the preparation of intravenous parenteral fluids.
Each 100 mL contains:
Essential Amino Acids | ||
Aminodrip (Lysine) (from Aminodrip (Lysine) Acetate, USP)……………………………………...1.18 | g | |
Leucine, USP……………………………………………………………...1.04 | g | |
Phenylalanine, USP……………………………………...1.04 | g | |
Valine, USP……………………………………………………………...960 | mg | |
Isoleucine, USP………………………………………...749 | mg | |
Methionine, USP………………………………………...749 | mg | |
Threonine, USP………………………………………...749 | mg | |
Tryptophan, USP………………………………………...250 | mg | |
Nonessential Amino Acids | ||
Alanine, USP…………………………………………...2.17 | g | |
Arginine, USP…………………………………………...1.47 | g | |
Glycine, USP…………………………………………...1.04 | g | |
Histidine, USP…………………………………………...894 | mg | |
Proline, USP……………………………………………………………...894 | mg | |
Glutamic Acid…………………………………………...749 | mg | |
Serine, USP……………………………………………...592 | mg | |
Aspartic Acid, USP……………………………………...434 | mg | |
Tyrosine, USP…………………………………………...39 | mg | |
Sodium Metabisulfite, NF added……………………………………………...30 | mg | |
Water for Injection, USP……………………………………………………... | qs | |
Essential Amino Acids………………………………………………………...6.7 | g | |
Nonessential Amino Acids…………………………………………………...8.3 | g | |
Total Amino Acids…………………………………………………………...15.0 | g | |
Total Nitrogen………………………………………………………………...2.37 | g | |
Acetate*……………………………………………………...151 | mEq/L | |
Osmolarity (calculated)……………………………………...1388 | mOsmol/L | |
pH……………………………………………………………………………...5.6(5.2-6.0) | ||
*Acetate from Aminodrip (Lysine) Acetate, USP and acetic acid used for pH adjustment. |
The formulas for the individual amino acids are as follows:
Formulas for individual amino acids
Aminodrip (Lysine)® 15% Amino Acids Injection providesseventeen crystalline amino acids. This completely utilizable substrate promotesprotein synthesis and wound healing and reduces the rate of protein catabolism.
A.Total Parenteral Nutrition (Central Infusion)
When enteralfeeding is inadvisable, Aminodrip (Lysine)® 15% given by central venousinfusion in combination with energy sources, vitamins, trace elements andelectrolytes, will completely satisfy the requirements for weight maintenanceor weight gain, depending upon the dose selected. The energy component inparenteral nutrition by central infusion may be derived solely from dextroseor may be provided by a combination of dextrose and intravenous fat emulsion. The addition of intravenous fat emulsion provides essential fatty acids andpermits a dietary balance of fat and carbohydrate, at the same time offeringthe option of reducing the dextrose load and/or increasing the total caloricinput. An adequate energy supply is essential for optimal utilization of aminoacids.
B. Total Parenteral Nutrition (Peripheral Infusion)
Aminodrip (Lysine)® 15%can also be administered as part of a total parenteral nutrition program byperipheral vein when the enteral route is inadvisable and use of the centralvenous catheter is contraindicated.
Reduction of proteinloss can be achieved by use of diluted Aminodrip (Lysine)® 15% in combinationwith dextrose or with dextrose and intravenous fat emulsion by peripheralinfusion. Complete peripheral intravenous nutrition can be achieved in patientswith low caloric requirements by a Aminodrip (Lysine)®15%-dextrose-fatregimen.
Aminodrip (Lysine)® 15% is indicated as an amino acid(nitrogen) source in parenteral nutrition regimens. This use is appropriatewhen the enteral route is inadvisable, inadequate or not possible, as when:
-Gastrointestinal absorption is impaired by obstruction, inflammatory diseaseor its complications, or antineoplastic therapy;
-Bowel rest is needed because of gastrointestinal surgery or its complicationssuch as ileus, fistulae or anastomotic leaks;
-Tube feeding methods alone cannot provide adequate nutrition.
This solution should not be used in patients in hepatic coma,severe renal failure, metabolic disorders involving impaired nitrogen utilizationor hypersensitivity to one or more amino acids.
Administration of amino acids solutions at excessive ratesor to patients with hepatic insufficiency may result in plasma amino acidimbalances, hyperammonemia, prerenal azotemia, stupor and coma. Conservativedoses of amino acids should be given to these patients, dictated by the nutritionalstatus of the patient. Should symptoms of hyperammonemia develop, amino acidadministration should be discontinued and the patient’s clinical statusre-evaluated.
Contains sodium metabisulfite, a sulfitethat may cause allergic-type reactions including anaphylactic symptoms andlife-threatening or less severe asthmatic episodes in certain susceptiblepeople. The overall prevalence of sulfite sensitivity in the general populationis unknown and probably low.
Sulfite sensitivity isseen more frequently in asthmatic than in nonasthmatic people.
WARNING: This product contains aluminum that maybe toxic. Aluminum may reach toxic levels with prolonged parenteral administrationif kidney function is impaired. Premature neonates are particularly at riskbecause their kidneys are immature, and they require large amounts of calciumand phosphate solutions, which contain aluminum.
Researchindicates that patients with impaired kidney function, including prematureneonates, who receive parenteral levels of aluminum at greater than 4 to 5mcg/kg/day accumulate aluminum at levels associated with central nervous systemand bone toxicity. Tissue loading may occur at even lower rates of administration.
A. GENERAL
It is essential to provide adequate calories concurrently if parenterally administered amino acids are to be retained by the body and utilized for protein synthesis.
The administration of Aminodrip (Lysine)® 15% Amino Acids Injection as part of total parenteral nutrition (TPN) with large volumes of hyperosmotic fluids requires periodic monitoring of the patient for signs of hyperosmolarity, hyperglycemia, glycosuria and hypertriglyceridemia.
During parenteral nutrition with concentrated dextrose and amino acids solutions, essential fatty acid deficiency syndrome may develop but may not be clinically apparent. Early demonstration of this condition can only be accomplished by gas liquid chromatographic analysis of plasma lipids. The syndrome may be prevented or corrected by appropriate treatment with intravenous fat emulsions.
For complete nutritional support, TPN regimens must also include multiple vitamins and trace elements. Potentially incompatible ions such as calcium and phosphate may be added to alternate infusate bottles to avoid precipitation. Although the metabolizable acetate ion in Aminodrip (Lysine)® 15% diminishes the risk of acidosis, the physician must be alert to the potential appearance of this disorder.
Initiation and termination of infusions of TPN fluids must be gradual to permit adjustment of endogenous insulin release.
Undiluted Aminodrip (Lysine)® 15% should not be administered peripherally. When administered centrally, it should be diluted with appropriate diluents, e.g., dextrose, electrolytes and other nutrient components, to at least half strength. See DOSAGE AND ADMINISTRATION.
Caution against volume overload should be exercised.
Drug product contains no more than 25 mcg/L of aluminum.
B. Laboratory Tests
Infusion of Aminodrip (Lysine)® 15% without concomitant infusion of an adequate number of non-protein calories may result in elevated BUN. Monitoring of BUN is required and the balance between Aminodrip (Lysine)® 15% and the calorie source may require adjustment. Frequent clinical evaluations and laboratory determinations are required to prevent the complications which may occur during the administration of solutions used in TPN. Laboratory tests should include blood glucose, serum electrolytes, liver and kidney function, serum osmolarity, blood ammonia, serum protein, pH, hematocrit, WBC and urinary glucose. When Aminodrip (Lysine)® 15% is combined with electrolytes, care should be used in administering this solution to patients with congestive heart failure, renal failure, edema, adrenal hyperactivity, acid-base imbalance and those receiving diuretics or antihypertensive therapy. Total volume infused should be closely monitored. Serum electrolytes should be monitored daily in these patients.
C. Carcinogenesis, Mutagenesis, Impairment of Fertility
Studies with Aminodrip (Lysine)® 15% have not been performed to evaluate carcinogenic potential, mutagenic potential, or effects on fertility.
D. Pregnancy Category C
Animal reproduction studies have not been conducted with Aminodrip (Lysine)® 15%. It is also not known whether Aminodrip (Lysine)® 15% can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Aminodrip (Lysine)® 15% should be given to a pregnant woman only if clearly needed.
E. Nursing Mothers
Caution should be exercised when Aminodrip (Lysine)® 15% is administered to a nursing woman.
F. Pediatric Use
Safety and effectiveness of Aminodrip (Lysine)® 15% Amino Acids Injection in pediatric patients have not been established by adequate and well-controlled studies. However, the use of amino acids injections in pediatric patients as an adjunct in the offsetting of nitrogen loss or in the treatment of negative nitrogen balance is referenced in the medical literature.
G. Special Precautions for Central Infusion
TPN delivered by indwelling catheter through a central or large peripheral vein is a special technique requiring a team effort by physician, nurse and pharmacist. The responsibility for administering this therapy should be confined to those trained in the procedures and alert to signs of complications. Complications known to occur from the placement of central venous catheter are pneumothorax, hemothorax, hydrothorax, artery puncture and transection, injury to the brachial plexus, malposition of the catheter, formation of arteriovenous fistula, phlebitis, thrombosis, and air/catheter emboli. The risk of sepsis is present during intravenous therapy, especially when using central venous catheters for prolonged periods. It is imperative that the preparation of admixtures and the placement and care of the catheters be accomplished under controlled aseptic conditions.
H. Admixtures
Admixtures should be prepared under a laminar flow hood using aseptic technique.
Admixtures should be stored under refrigeration and must be administered within 24 hours after removal from refrigerator.
Filters of less than 1.2 micron pore size must not be used with admixtures containing fat emulsion.
I. Do not administer unless solution is clear and the seal is intact.
IT IS ESSENTIAL THAT A CAREFULLY PREPARED PROTOCOL, BASED ON CURRENT MEDICAL PRACTICES, BE FOLLOWED, PREFERABLY BY AN EXPERIENCED TEAM.
In the event of overhydration or solute overload, re-evaluatethe patient and institute appropriate corrective measures. See WARNINGS andPRECAUTIONS.
The appropriate daily dose of amino acids to be used withdextrose or with dextrose and intravenous fat emulsion will depend upon themetabolic status and clinical response of the patient as therapy proceeds. Doses which achieve nitrogen equilibrium or positive balance are the mostdesirable. The dosage on the first day should be approximately half the anticipatedoptimal dosage and should be increased gradually to minimize glycosuria; similarly,withdrawal should be accomplished gradually to avoid rebound hypoglycemia.
Fatemulsion coadministration should be considered when prolonged (more than 5days) parenteral nutrition is required in order to prevent essential fattyacid deficiency (EFAD). Serum lipids should be monitored for evidence of EFADin patients maintained on fat free TPN.
The amount administeredis dosed on the basis of amino acids/kg of body weight/day. In general, twoto three g/kg of body weight for neonates and infants with adequate caloriesare sufficient to satisfy protein needs and promote positive nitrogen balance. In pediatric patients, the final solution should not exceed twice normal serumosmolarity (718 mOsmol/L).
DIRECTIONSFOR PROPER USE OF PHARMACY BULK PACKAGE
Aminodrip (Lysine)® 15%in a Pharmacy Bulk Package is not intended for direct infusion. The containerclosure may be penetrated only once using a suitable sterile transfer deviceor dispensing set which allows measured dispensing of the contents. The PharmacyBulk Package is to be used only in a suitable work area such as a laminarflow hood (or an equivalent clean air compounding area). Once the closureis penetrated, the contents should be dispensed as soon as possible; the transferof contents must be completed within 4 hours of closure entry. The bottlemay be stored at room temperature (25°C) after the closure has been entered. Date and time of container entry should be noted in the area designated onthe container label.
When using Aminodrip (Lysine)® 15%in patients with a need for fluid volume restriction, it can be diluted asfollows:
| | | |
Aminodrip (Lysine)® 15% | 500 mL | 75 g | 7.5% |
Dextrose 70% | 250 mL | 175 g | 17.5% |
Intralipid® 20% | 250 mL | 50 g | 5.0% |
This will provide 1395 kilocalories (kcal) per 1000 mLof admixture with a ratio of 118 non-protein calories per gram of nitrogenand an osmolarity of 1561 mOsmol/L.
In patients wherethe need for fluid restriction is not so marked, either of the following regimensmay be used dependent upon the energy needs of the patient.
| | | |
Aminodrip (Lysine)® 15% | 500 mL | 75 g | 3.75% |
Dextrose 50% | 1000 mL | 500 g | 25% |
Intralipid® 20% | 500 mL | 100 g | 5% |
This will provide 1500 kcal per 1000 mL of admixture witha ratio of 228 non-protein calories per gram of nitrogen and an osmolarityof 1633 mOsmol/L.
| | | |
Aminodrip (Lysine)® 15% | 500 mL | 75 g | 3.75% |
Dextrose 30% | 1000 mL | 300 g | 15% |
Intralipid® 10% | 500 mL | 50 g | 2.5% |
This will provide 935 kcal per 1000 mL of admixture witha ratio of 158 non-protein calories per gram of nitrogen and an osmolarityof 1128.5 mOsmol/L.
A. Total Parenteral Nutrition (CentralInfusion)
In unstressed adult patients with no unusualnitrogen losses, a minimum dosage of 0.1 gram nitrogen (4.2 mL of Aminodrip (Lysine)® 15%)plus 4.4 grams (15 calories) of dextrose per kilogram of body weight per dayare required to achieve nitrogen balance and weight stability. Intravenousfat emulsion may be used as a partial substitute for dextrose. This regimenprovides a ratio of 150 non-protein calories per gram of nitrogen.
Forpatients stressed by surgery, trauma or sepsis, and those with unusual nitrogenlosses, the dosage required for maintenance may be as high as 0.3 to 0.4 gramsof nitrogen (13 to 17 mL Aminodrip (Lysine)® 15%) per kilogram of bodyweight per day, with proportionate increases in non-protein calories. Periodicassessment of nitrogen balance of the individual patient is the best indicatorof proper dosage. Volume overload and glycosuria may be encountered at highdosage, and nitrogen balance may not be achieved in extremely hypermetabolicpatients under these constraints. Concomitant insulin administration may berequired to minimize glycosuria. Daily laboratory monitoring is essential.
Useof an infusion pump is advisable to maintain a steady infusion rate duringcentral venous infusion.
B. Peripheral Nutrition
Inpatients for whom central venous catheterization is not advisable, proteincatabolism can be reduced by peripheral use of diluted Aminodrip (Lysine)® 15%plus non-protein calorie sources. Dilution of 250 mL Aminodrip (Lysine)® 15%in 750 mL of 10% dextrose will reduce the osmolarity to a level (724 mOsmol/L)which is more favorable to the maintenance of the integrity of the walls ofthe veins. Intravenous fat emulsion can be infused separately or simultaneously;if infused simultaneously the fat emulsion will provide a dilution effectupon the osmolarity while increasing the energy supply.
Parenteraldrug products should be inspected visually for particulate matter and discolorationprior to administration, whenever solution and container permit.
Toreduce the risk of bacterial contamination, all intravenous administrationsets should be replaced at least every 24 hours. Usage of admixtures mustbe initiated within 24 hours after mixing. If storage is necessary duringthis 24 hour period, admixtures must be refrigerated and completely used within24 hours of beginning administration.
Aminodrip (Lysine)® 15% Amino Acids Injection is suppliedas a Pharmacy Bulk Package in 500 mL containers.
500mL NDC 0409-0468-05
STORAGE
Store inthe closed carton; do not expose solution to light until ready for use. Exposureof pharmaceutical products to heat should be minimized. Avoid excessive heat. It is recommended that the product be stored at 20 to 25°C (68 to 77°F). Brief exposure to temperatures above25°C during transport and storage will not adversely affect the product. Solution that has been frozen must not be used.
©Hospira 2005 | EN-1010 |
Hospira, Inc., Lake Forest, IL 60045 USA
RL-1450
Tryptophan:
Depending on the reaction of the Aminodrip after taken, if you are feeling dizziness, drowsiness or any weakness as a reaction on your body, Then consider Aminodrip not safe to drive or operate heavy machine after consumption. Meaning that, do not drive or operate heavy duty machines after taking the capsule if the capsule has a strange reaction on your body like dizziness, drowsiness. As prescribed by a pharmacist, it is dangerous to take alcohol while taking medicines as it exposed patients to drowsiness and health risk. Please take note of such effect most especially when taking Primosa capsule. It's advisable to consult your doctor on time for a proper recommendation and medical consultations.
Is Aminodrip addictive or habit forming?Medicines are not designed with the mind of creating an addiction or abuse on the health of the users. Addictive Medicine is categorically called Controlled substances by the government. For instance, Schedule H or X in India and schedule II-V in the US are controlled substances.
Please consult the medicine instruction manual on how to use and ensure it is not a controlled substance.In conclusion, self medication is a killer to your health. Consult your doctor for a proper prescription, recommendation, and guidiance.
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The information was verified by Dr. Rachana Salvi, MD Pharmacology