Doltrix: Pharmacology, Indications, Contraindications, Warnings and Precautions

Refers to a spectrum selective antispasmodic.

The Doltrix (lysine hydrochloride) 15%. It is a sterile dose from which it contains several single doses for use in a pharmacy mixing program in the preparation of intravenous parenteral fluids.

What is Doltrix (lysine hydrochloride) 15% for

Doltrix (lysine hydrochloride) 15% is an essential amino acid. Essential means that it is not produced by the body and therefore must be taken through diet or by taking supplements.

Doltrix (lysine hydrochloride) 15% is found in foods such as lentils, red meat, pork, poultry, cod, sardines, walnuts, eggs, soybeans, brewer’s yeast, and dairy products.

Doltrix (lysine hydrochloride) 15% has been used in alternative medicine as an aid to prevent cold sores around the mouth (caused by the herpes simplex virus). This product can make cold sores occur less often and may reduce the number of days that cold sores last. Doltrix is ​​not a cure for herpes.

Other uses for Doltrix (lysine hydrochloride) 15% include treating metabolic acidosis, improving athletic performance, and helping the body absorb calcium supplements. Not all uses for Doltrix have been approved by the FDA. Doltrix should not be used in place of the medicines prescribed for you by your doctor.

Pharmacology

The Doltrix (lysine hydrochloride) 15% Amino Acid Injection, provides seven crystalline amino acids. This fully usable substrate promotes protein synthesis and wound healing and reduces the rate of protein catabolism.

 Total parenteral nutrition (central infusion)

When enteral feeding is not recommended, Doltrix (lysine hydrochloride) 15% given by central venous infusion in combination with energy sources, vitamins, trace elements and electrolytes, will fully satisfy the weight maintenance or weight gain requirements, depending on the dose. selected.

The energy component in central infusion parenteral nutrition can be derived solely from dextrose, and can be provided by a combination of dextrose and intravenous fat emulsion.

The addition of the intravenous fat emulsion provides essential fatty acids and allows a dietary balance of fats and carbohydrates, while offering the option of reducing the dextrose load and / or increasing the total caloric input.

An adequate energy supply is essential for the optimal utilization of amino acids.

Total parenteral nutrition (peripheral infusion)

Doltrix (lysine hydrochloride) 15% can also be administered as part of a total parenteral nutrition (TPN) program by peripheral vein when the enteral route is inadvisable and the use of the central venous catheter is contraindicated.

Reduction of protein loss can be achieved by using diluted Doltrix in combination with dextrose and intravenous fat emulsion by peripheral fusion.

Complete peripheral intravenous nutrition can be achieved in patients with low caloric requirements by a Doltrix (lysine hydrochloride) 15% -dextrose-fat regimen.

Indications and use

Doltrix (lysine hydrochloride) 15% is indicated as a source of amino acids (nitrogen) in parenteral nutrition regimens.

This use is appropriate when the enteral route is inadvisable, inappropriate or not possible, such as when:

  • Gastrointestinal absorption is affected by obstruction, inflammatory disease or its complications, or antineoplastic therapy.
  • It is necessary due to gastrointestinal surgery or its complications such as ileus, fistulas or anastomotic leaks.
  • Tube feeding methods alone cannot provide adequate nutrition.

Contraindications

This solution should not be used in patients with hepatic coma, severe renal failure, metabolic disorders involving poor nitrogen utilization, or hypersensitivity to one or more amino acids.

Warnings

Administration of amino acid solutions at excessive rates or to patients with hepatic impairment can lead to plasma amino acid imbalances, hyperammonemia, prerenal azotemia, stupor, and coma.

Conservative doses of amino acids should be administered to these patients, dictated by the nutritional status of the patient. In the event of symptoms of hyperammonemia, the administration of amino acids should be discontinued and the clinical status of the patient should be evaluated.

Doltrix contains sodium metabisulfite, a sulfite that can cause allergic-type reactions, including anaphylactic symptoms and life-threatening or less severe asthmatic episodes in certain susceptible individuals.

The overall prevalence of sulfite sensitivity in the general population is unknown and probably low. Sulfite sensitivity is seen more often in asthmatic people than in non-asthmatic people.

This product contains aluminum which can be toxic. Aluminum can reach toxic levels with prolonged parenteral administration if kidney function is impaired.

Preterm infants are at special risk because their kidneys are immature and require large amounts of aluminum-containing calcium and phosphate solutions.

Research indicates that kidney failure patients, including premature infants, who receive parenteral aluminum levels greater than 4 to 5 mcg / kg / day accumulate aluminum at levels associated with central nervous system and bone toxicity.

Tissue loading can occur at even lower rates of administration.

General precautions

Providing adequate calories at the same time is essential if parenterally administered amino acids are to be retained by the body and used for protein synthesis.

Administration of Doltrix (lysine hydrochloride) 15% as part of total parenteral nutrition with large volumes of hyperosmotic fluids requires periodic monitoring of the patient for signs of:

  • Hyperosmolarity
  • Hyperglycemia
  • Glucosuria.
  • Hypertriglyceridemia.

During parenteral nutrition with concentrated dextrose and amino acid solutions, essential fatty acid deficiency syndrome may develop, but may not be clinically evident.

Early demonstration of this condition can only be achieved by gas liquid chromatographic analysis of plasma lipids. The syndrome can be prevented or corrected by appropriate treatment with intravenous fat emulsions.

For complete nutritional support, TPN regimens should also include multiple vitamins and trace elements.

Potentially incompatible ions, such as calcium and phosphate, can be added to alternate infusion bottles to avoid precipitation. Although the metabolizable acetate ion in Doltrix (lysine hydrochloride) 15% reduces the risk of acidosis, the doctor should be aware of the possible appearance of this disorder.

The initiation and termination of TPN fluid infusions should be gradual to allow adjustment of endogenous insulin release.

Undiluted, Doltrix (lysine hydrochloride) 15% should not be administered peripherally. When administered centrally, it must be diluted with appropriate diluents, eg, dextrose, electrolytes, and other nutrient components, to at least half its strength.

Caution should be exercised against volume overload. The drug does not contain more than 25 mcg / L of aluminum.

Lab tests

Infusion of Doltrix (lysine hydrochloride) 15% without concomitant infusion of an adequate number of calories without protein may result in elevated BUN.

BUN monitoring and adjustment between Doltrix (lysine hydrochloride) 15% and calorie source may require adjustments.

Frequent clinical evaluations and laboratory determinations are required to prevent complications that can occur during administration of the solutions used in TPN.

Laboratory tests should include:

  • Blood glucose.
  • Serum electrolytes.
  • Liver and kidney function.
  • Serum osmolarity.
  • Ammonia in blood.
  • Serum protein.
  • PH.
  • Hematocrit
  • White blood cells
  • Urinary glucose.

When Doltrix (lysine hydrochloride) 15% is combined with electrolytes, care should be taken when administering this solution to patients with congestive heart failure, kidney failure, edema, adrenal hyperactivity, acid-base imbalance, and those receiving diuretics or antihypertensive therapy.

The total volume infused should be closely monitored. Serum electrolytes should be monitored daily in these patients.

Carcinogenesis, mutagenesis, impaired fertility

No studies have been performed with Doltrix (lysine hydrochloride) 15% to evaluate carcinogenic potential, mutagenic potential, or effects on fertility.

Pregnancy category C

Animal reproduction studies have not been conducted with Doltrix. It is also not known whether Doltrix can cause fetal harm when administered to pregnant women or can affect the ability to reproduce.

Doltrix should be administered to a pregnant woman only if clearly necessary.

Nursing Mothers: Caution should be exercised when Doltrix is ​​administered to a nursing woman.

Pediatric use

The safety and efficacy of Doltrix Amino Acid Injection in pediatric patients have not been established through adequate and well-controlled studies.

However, the use of amino acid injections in pediatric patients as an adjunct in compensating for nitrogen loss or in treating negative nitrogen balance is mentioned in the medical literature.

Special Precautions for Central Infusion

TPN delivered by indwelling catheter through a central or large peripheral vein is a special technique that requires a team effort on the part of the doctor, nurse, and pharmacist.

The responsibility for administering this therapy should be limited to those trained in the procedures and alert to signs of complications.

Complications known to occur from central venous catheter placement include:

  • Pneumothorax.
  • Hemothorax.
  • Hydrothorax.
  • Puncture and transection of the artery.
  • Brachial plexus injury.
  • Catheter malposition.
  • Formation of arteriovenous fistula.
  • Phlebitis, thrombosis, and air / catheter emboli.

The risk of sepsis is present during intravenous therapy, especially when central venous catheters are used for long periods.

Additions

Additives should be prepared under a laminar flow hood using aseptic technique. Mixtures should be stored under refrigeration and should be administered within 24 hours of removal from the refrigerator.

Filters with a pore size less than 1.2 microns should not be used with additives containing fat emulsion.

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

Overdose

In the event of overhydration or solute overload, reevaluate the patient and institute appropriate corrective measures.

The appropriate daily dose of amino acids to be used with dextrose or with dextrose and intravenous fat emulsion will depend on the metabolic status and clinical response of the patient as therapy progresses.

Doses that achieve nitrogen balance or positive balance are the most desirable.

The dosage on the first day should be approximately half of the anticipated optimal dose and should be increased gradually to minimize glycosuria; similarly, abstinence should be done gradually to avoid rebound hypoglycemia.

The amount administered is dosed on the basis of amino acids / kg of body weight / day. In general, two to three g / kg of body weight for infants and children with adequate calories is sufficient to meet protein needs and promote a positive nitrogen balance.

In pediatric patients, the final solution should not exceed twice normal serum (718 mOsmol / L).