Cotaryl

Uses

1. Expectorant in cough syrups.
2. The ammonium ion (NH4+) in the body plays an important role in the maintenance of acid-base balance. The kidney uses ammonium (NH4+) in place of sodium (Na+) to combine with fixed anions in maintaining acid-base balance, especially as a homeostatic compensatory mechanism in metabolic acidosis. The therapeutic effects of Ammonium Chloride depend upon the ability of the kidney to utilize ammonia in the excretion of an excess of fixed anions and the conversion of ammonia to urea by the liver, thereby liberating hydrogen (H+) and chloride (Cl–) ions into the extracellular fluid. Ammonium Chloride Injection, USP, after dilution in isotonic sodium chloride injection, may be indicated in the treatment of patients with: (1) hypochloremic states and (2) metabolic alkalosis.

Calcium Lactate is used for heartburn, calcium supplement, calcium deficiencies.

This is used for irrigating fluid of choice in:

• Transurethral resection of prostate.
• Endoscopic procedures within the urinary tract.
• Urinary bladder surgery etc.

Lactic acid is an emollient and keratolytic used agent in various cosmetic products and used as an additive in various pharmaceutical products for its antibacterial properties.

For use as an alkalinizing agent.

Magnesium chloride is an ionic compound and source of magnesium used for electrolyte replenishment and conditions associated with magnesium deficiencies.

Magnesium chloride is used in several medical and topical (skin related) applications. Magnesium chloride usp, anhydrous uses as electrolyte replenisher, pharmaceutic necessity for hemodialysis and peritoneal dialysis fluids.

Potassium chloride is used for drug induced hypokalemia, liver cirrhosis, nausea, vomiting, cholera, diarrhoea, muscular weakness, paralysis, cardiac and congestive heart failure, diabetic ketoacidosis, ulcerative colitis, weakness, anorexia, drowsiness, Cushing's syndrome, pyloric stenosis, low blood pressure etc.

Urea 25% cream is used for the treatment of dry, cracked skin and hyperkeratosis on the soles of the feet including the heels. Suitable for general and diabetic foot care.

Cotaryl is also used to associated treatment for these conditions: Allergic Reaction, Allergic cough, Common Cold, Cough, Cough caused by Common Cold, Diabetes, High Blood Pressure (Hypertension), Metabolic Alkalosis, Nasal Congestion, Nasal Congestion Due to Allergic Rhinitis, Productive cough, Rhinorrhoea, Sneezing, Bronchial congestion, Dry cough, Excess mucus or phlegm, Hypochloremic state, Airway secretion clearance therapy, Bronchodilation, Parenteral rehydration therapy, Weight Loss, PotassiumCalcium DeficiencyCoronary vascular graft occlusion, Deep Vein Thrombosis, Myocardial Infarction, Stroke, Transient Ischemic Attack, Vascular Occlusion, Bladder distension, Bladder irrigation therapy, Irrigation therapy, Recovery, Amino acid supplementationCorns, Dehydration, Fluid Loss, Hyperkeratosis, Lichenification, Shock, Hypovolemic, Vasoplegic Shock, Warts, Mild Metabolic acidosis, Mild, moderate Metabolic Acidosis, Moderate Metabolic acidosis, Chemical contraception, Electrolyte replacement, Fluid replacement therapy, Parenteral Nutrition, Peritoneal dialysis therapy, Urine alkalinization therapyElectrolyte imbalance, Magnesium Deficiency, Mild Metabolic acidosis, Automated peritoneal dialysis, Continuous Renal Replacement Therapy, Continuous ambulatory peritoneal dialysis therapy, Fluid replacement therapy, Hemodialysis Treatment, Irrigation therapy, Organ Preservation, Parenteral rehydration therapy, Peritoneal dialysis therapy, Total parenteral nutrition therapy, Urine alkalinization therapy, Fluid and electrolyte maintenance therapyDehydration, Dry Mouth, Hypokalemia, Hypotonic Dehydration, Hypovolaemia, Isotonic Dehydration, Markedly Reduced Food Intake, Metabolic Acidosis, Hypodermoclysis, Mild Metabolic acidosis, Mild, moderate Metabolic Acidosis, Ocular edema, Acid-Base Balance, Bowel preparation therapy, Electrolyte replacement, Fluid replacement therapy, Hemodialysis Treatment, Hemofiltration, Parenteral Nutrition, Parenteral rehydration therapy, Plasma Volume Replacement, Urine alkalinization therapy, Fluid and electrolyte maintenance therapyDermatitis, Dermatitis, Contact, Dermatitis, Eczematous, Dry Eyes, Dry Skin, Dry Skin; Eczema, Eczema, Dyshidrotic, Eye pruritus, Helicobacter Pylori Infection, Insect Bites, Lichen Planus (LP), Neurodermatitis, Nummular Dermatitis, Psoriasis, Seborrheic Dermatitis, Sunburn, Allergic skin manifestations, Anal eczema, Calluses, Moisturizing

How Cotaryl works

Ammonium chloride increases acidity by increasing the amount of hydrogen ion concentrations.

Ammonium chloride can be used as an expectorant due to its irritative action on the bronchial mucosa. This effect causes the production of respiratory tract fluid which in order facilitates the effective cough.

In aqueous environments such as the gastrointestinal (GI) tract, calcium lactate will dissociate into calcium cation and lactic acid anions, the conjugate base of lactic acid. Lactic acid is a naturally-occurring compound that serves as fuel or energy in mammals by acting as an ubiquitous intermediate in the metabolic pathways . Lactic acid diffuses through the muscles and is transported to the liver by the bloodstream to participate in gluconeogenesis .

In the CNS, there exist strychnine-sensitive glycine binding sites as well as strychnine-insensitive glycine binding sites. The strychnine-insensitive glycine-binding site is located on the NMDA receptor complex. The strychnine-sensitive glycine receptor complex is comprised of a chloride channel and is a member of the ligand-gated ion channel superfamily. The putative antispastic activity of supplemental glycine could be mediated by glycine's binding to strychnine-sensitive binding sites in the spinal cord. This would result in increased chloride conductance and consequent enhancement of inhibitory neurotransmission. The ability of glycine to potentiate NMDA receptor-mediated neurotransmission raised the possibility of its use in the management of neuroleptic-resistant negative symptoms in schizophrenia.
Animal studies indicate that supplemental glycine protects against endotoxin-induced lethality, hypoxia-reperfusion injury after liver transplantation, and D-galactosamine-mediated liver injury. Neutrophils are thought to participate in these pathologic processes via invasion of tissue and releasing such reactive oxygen species as superoxide. In vitro studies have shown that neutrophils contain a glycine-gated chloride channel that can attenuate increases in intracellular calcium and diminsh neutrophil oxidant production. This research is ealy-stage, but suggests that supplementary glycine may turn out to be useful in processes where neutrophil infiltration contributes to toxicity, such as ARDS.

Lactate ions are metabolized ultimately to carbon dioxide and water, which requires the consumption of hydrogen cations.

Mechanism of action of magnesium chloride studied in 10 adult volunteers. Results suggested magnesium ion in duodenum is relatively weak stimulus to pancreas and gall bladder. It is weak stimulant to cholecystokinin release and inhibits net jejunal water absorption. The oral administration of a single 800 mg dose of magnesium chloride in healthy volunteers resulted in a diminished rate of intraluminal lipid and protein digestion. The most pronounced effect of magnesium chloride, however, was a decreased gastric emptying rate of both test meals. After correction for gastric emptying, no differences were noted in intraluminal lipid or protein digestion. Therefore, the lower lipid levels noted after magnesium supplementation are unlikely to be the result of altered lipid assimilation. Magnesium chloride slows gastric emptying but does not influence lipid digestion.

Supplemental potassium in the form of high potassium food or potassium chloride may be able to restore normal potassium levels.

Dosage

Cotaryl dosage

19-50 year: 1,000 mg elemental Calcium Lactate per day.

>50 year: 1,200 mg elemental Calcium Lactate per day.

The total volume of solution used for irrigation depends on the judgment of the attending surgeon. Height from the operating table of 60 cm (approx. 2ft) is likely to cause increased intravascular absorption of glycine.

Oral:Dosage must be adjusted to the individual needs of each patient.

• Adults: In severe deficiencies 3-6 tablets or 4-8 teaspoonful or 25-50 mmol per day orally in divided doses for some days with fruit juice, sweet or plain water.
• Children: ½-1 teaspoonful twice daily or 1-3 mmol/kg body weight a day in several divided doses.

Patient should take Potassium chloride with meals.

Intravenous:

Severe acute hypokalaemia:

• Adult: If serum potassium level >2.5 mEq/L, give at a rate not exceeding 10 mEq/hr in a concentration of up to 40 mEq/L. Max dose: 200 mEq/24 hr. If serum potassium level <2 mEq/L, may infuse at a rate of up to 40 mEq/hr. Continuous cardiac monitoring is essential. Max dose: 400 mEq/24 hr.

75 mg KCl equivalent to 1 mmol K+

Apply a small amount twice daily to the skin after washing or bathing.

In extreme cases, before bed you may choose to cover the feet with plastic wrap and then put socks over the plastic wrap to increase the hydration rate.

Recommended for use on adults and children over 12 years.

After use, wear sandals or slippers to avoid staining carpets.

• Check infusion set and infusion solution prior to use
• Pull moderately to tear off the protective cover of the Eurohead
• Hold lightly the Eurohead but not the bag
• Open the flow regulator fully and hold the giving set on the top white area, but not the membrane venting region
• Insert the spike of the administration set to the Eurohead and fit the connector of the administration set firmly to the needle
• Gradually allow the fluid to flow down to the needle tip and close
• Remove the protective cover of the needle
• Locate the veinpuncture site and clean the site with an antiseptic solution, and then insert the needle
• Securely tape the puncture site
• Securely tape the wings and tubing
• Start infusion while adjusting drip speed

Side Effects

Gl discomfort e.g. nausea, vomiting, constipation; bradycardia, arrhythmias. Dry mouth, increased thirst or increased urination. Mental confusion, milk-alkali syndrome.

Large intravenous doses of glycine are known to cause nausea and salivation. Other consequences of systemic absorption of glycine include electrolyte loss, diuresis, edaema, thirst, dehydration, cardiovascular and pulmonary disorders.

GI ulceration (sometimes with haemorrhage and perforation or with late formation of strictures) following the use of enteric-coated K chloride preparation; hyperkalaemia. Oral: Nausea, vomiting, diarrhoea and abdominal cramps. IV: Pain or phloebitis; cardiac toxicity.

May irritate inflamed skin or exudative lesions. Transient stinging may occur in deep cracks. Discontinue use if local irritation or rash occurs during use.

Toxicity

LD50 "Rat" after oral administration is: 1650 mg/kg. Overdosage of Ammonium Chloride has resulted in a serious degree of metabolic acidosis, disorientation, confusion and coma. If metabolic acidosis occur following overdosage, the administration of an alkalinizing solution such as sodium bicarbonate or sodium lactate will serve to correct the acidosis.

Patients administering Ammonium chloride should be watched to the signs of ammonia toxicity including (pallor, sweating, irregular breathing, bradycardia, cardiac arrhythmias, local and general twitching, tonic convulsions and coma). It should be used with caution in patients with high total CO2 and buffer base secondary to primary respiratory acidosis. Intravenous administration should be slow to avoid local irritation and toxic effects.

The LDLo of calcium lactate pentahydrate following intravenous administration in mouse is 140 mg/kg .

ORL-RAT LD₅₀ 7930 mg/kg, SCU-RAT LD₅₀ 5200 mg/kg, IVN-RAT LD₅₀ 2600 mg/kg, ORL-MUS LD₅₀ 4920 mg/kg; Doses of 1 gram daily are very well tolerated. Mild gastrointestinal symptoms are infrequently noted. In one study doses of 90 grams daily were also well tole.

Mouse LD50 775mg/kg (intraperitoneal) Mouse LD50 : 7600mg/kg (oral) Rat LD 50 : 8100mg/kg (oral) Rat LD50 176mg/kg (intravenous) Severe toxicity occurs most often after intravenous infusions. It can also occur after chronic excessive oral doses, often in patients with renal insufficiency. Early manifestations are lethargy, hyporeflexia, followed by weakness, paralysis, hypotension, ECG changes (prolonged PR and QRS intervals), CNS depression, seizures, and respiratory depression. In overdose, magnesium impairs neuromuscular transmission, manifested as weakness and hyporeflexia.

The administration of oral potassium salts to persons with normal excretory mechanisms for potassium rarely causes serious hyperkalemia. However, if excretory mechanisms are impaired, of if potassium is administered too rapidly intravenously, potentially fatal hyperkalemia can result. It is important to recognize that hyperkalemia is usually asymptomatic and may be manifested only by an increased serum potassium concentration (6.5-8.0 mEq/L) and characteristic electrocardiographic changes (peaking of T-waves, loss of P-wave, depression of S-T segment, and prolongation of the QT interval). Late manifestations include muscle paralysis and cardiovascular collapse from cardiac arrest (9-12 mEq/L).

Precaution

Sarcoidosis; history of nephrolithiasis. Avoid IV admin of calcium in patients on cardiac glycosides. Increased risk of hypercalcaemia and hypercalciuria in hypoparathyroid patients receiving high doses of vitamin D. Caution when used in patients with history of kidney stones. Patients should be advised to administer vitamin D concurrently to optimise calcium absorption. Pregnancy.

Precautions: Patients with cardiovascular disease should be evaluated after transurethral resection of prostate using glycine. Care should be exercised if the liver or kidney is impaired.

Warning: Aseptic technique is essential while using glycine. Unused portion should be discarded. Do not use if the bottle is leaking, solution is cloudy, contains particles or after expiry date.

Renal or adrenocortical insufficiency; cardiac disease; acute dehydration; extensive tissue destruction. Pregnancy. Ensure adequate urine output; monitor plasma-potassium and other electrolyte concentrations. Discontinue treatment if severe nausea, vomiting or abdominal distress develops. Accumulation of potassium may occur in renal impairment.

Interaction

May reduce the efficacy of calcium-channel blockers. Concurrent admin of IV calcium salt with cardiac glycosides may lead to serious adverse events. Increased risk of hypercalcaemia when used with thiazide diuretics. May reduce absorption of tetracycline, alendronate, atenolol, iron, quinolone antibiotics, sodium fluoride and zinc.

Additives may be incompatible. When introducing additives, use aseptic technique, mix thoroughly and do not store.

Potassium-sparing diuretics, ACE inhibitors, ciclosporin and potassium-containing drugs. Antimuscarinics delay gastric emptying time consequently increasing risk of GI adverse effects esp of solid oral dosage forms.

Volume of Distribution

Data not found.

The majority of calcium absorbed (99%) is stored in the skeleton and teeth for structural integrity .

Bone (50% to 60%); extracellular fluid (1% to 2%)

Elimination Route

Completely absorbed within 3–6 h. In healthy persons, absorption of ammonium chloride given by mouth was practically complete. Only 1 to 3% of the dose was recovered in the feces.

In order to be absorbed, calcium must be in its freely soluble form (Ca2+) or bound to a soluble organic molecule. Calcium absorption mainly occurs at the duodenum and proximal jejunum due to more acidic pH and the abundance of the calcium binding proteins . The mean calcium absorption is about 25% of calcium intake (range is 10 – 40%) in the small intestine, and is mediated by both passive diffusion and active transport .

Absorbed from the small intestine via an active transport mechanism.

Oral: Inversely proportional to amount ingested; 40% to 60% under controlled dietary conditions; 15% to 36% at higher doses

Potassium is a normal dietary constituent and under steady-state conditions the amount of potassium absorbed from the gastrointestinal tract is equal to the amount excreted in the urine.

Half Life

Unknown

No pharmacokinetic data available.

Elimination half-life has been reported to be 27.7 hours following an overdose of 400 mEq magnesium in an adult.

Clearance

Data not found.

No pharmacokinetic data available.

Maximum magnesium clearance is directly proportional to creatinine clearance.

Elimination Route

Excretion: Urine

Following oral administration to a human volunteer, 20 to 30% of a dose of lactic acid of up to 3000 mg was excreted via the urine during a period of 14 hours .

Magnesium is excreted in urine. Unabsorbed magnesium is excreted in feces

Potassium is a normal dietary constituent and, under steady-state conditions, the amount of potassium absorbed from the gastrointestinal tract is equal to the amount excreted in the urine. Potassium depletion will occur whenever the rate of potassium loss through renal excretion and/or loss from the gastrointestinal tract exceeds the rate of potassium intake.

Pregnancy & Breastfeeding use

Pregnancy Category-C. Animal reproduction studies have shown an adverse effect on the fetus and there are no adequate and well-controlled studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks

Category C: Either studies in animals have revealed adverse effects on the foetus (teratogenic or embryocidal or other) and there are no controlled studies in women or studies in women and animals are not available. Drugs should be given only if the potential benefit justifies the potential risk to the foetus.

Urea cream can be used during pregnancy and lactation.

Contraindication

Conditions associated with hypercalcaemia and hypercalciuria.

Glycine Irrigation Solution is not for injection in any route. It is contraindicated in patients with anuria.

Hyperchloraemia, severe renal or adrenal insufficiency.

For use only on the soles of the feet and heels unless otherwise directed by the prescriber. Pregnant women should consult their Healthcare Professional before use. For External Use Only. Avoid contact with eyes. Keep out of reach of children. Always replace cap after use. Do not use if tube seal is broken or appears tampered with.

Storage Condition

Store at controlled room temperature, protect from light and heat

Intravenous: Store at 15-30° C.

Oral: Store below 30° C.

Store between 10° – 30° C in a dry place. Keep lid tightly closed.

Innovators Monograph

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