Calmin-600

Calmin-600 Uses, Dosage, Side Effects, Food Interaction and all others data.

Amino Acids is a sterile aqueous solution, consisting of crystalline amino acids and D-sorbitol with electrolytes. Amino Acids is necessary as the nitrogen sources for parenteral nutrition in which nitrogen is provided in the form of essential and non-essential amino acids. The solution is clear, colorless having a pH lying in the range of 5.7 to 7.0.

CompositionEach 100 ml contains:

i) Active ingredients Specification Quantity

L-Isoleucine USP 0.352 gm

L-Leucine USP 0.490 gm

An important compound functioning as a component of the coenzyme NAD. Its primary significance is in the prevention and/or cure of blacktongue and pellagra. Most animals cannot manufacture this compound in amounts sufficient to prevent nutritional deficiency and it therefore must be supplemented through dietary intake.

Potassium chloride is a major cation of the intracellular fluid. It plays an active role in the conduction of nerve impulses in the heart, brain and skeletal muscle; contraction of cardiac skeletal and smooth muscles; maintenance of normal renal function, acid-base balance, carbohydrate metabolism and gastric secretion.

The potassium ion is in the principle intracellular cation of most body tissues. Potassium ions participate in a number of essential physiological processes including the maintenance of intracellular tonicity, the transmission of nerve impulses, the contraction of cardiac, skeletal and smooth muscle, and the maintenance of normal renal function. The intracellular concentration of potassium is approximately 150 to 160 mEq per liter. The normal adult plasma concentration is 3.5 to 5 mEq per liter. An active ion transport system maintains this gradient across the plasma membrane. 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. The usual dietary intake of potassium is 50 to 100 mEq per day. 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. Such depletion usually develops as a consequence of therapy with diuretics, primarily or secondary hyperaldosteronism, diabetic ketoacidosis, or inadequate replacement of potassium in patients on prolonged parenteral nutrition. Depletion can develop rapidly with severe diarrhea, especially if associated with vomiting. Potassium depletion due to these causes is usually accompanied by concomitant loss of chloride and is manifested by hypokalemia and metabolic alkalosis. Potassium depletion may produce weakness, fatigue, disturbances of cardiac rhythm (primarily ectopic beats), prominent U-waves in the electrocardiogram, and, in advanced cases, flaccid paralysis and/or impaired ability to concentrate urine. If potassium depletion associated with metabolic alkalosis cannot be managed by correcting the fundamental cause of the deficiency, e.g., where the patient requires long-term diuretic therapy, supplemental potassium in the form of high potassium food or potassium chloride may be able to restore normal potassium levels. In rare circumstances (e.g., patients with renal tubular acidosis) potassium depletion may be associated with metabolic acidosis and hyperchloremia. In such patients, potassium replacement should be accomplished with potassium salts other than the chloride, such as potassium bicarbonate, potassium citrate, potassium acetate, or potassium gluconate.

Pyridoxine is a water-soluble vitamin which functions in the metabolism of carbohydrates, proteins and fats. It is essential in Hb formation and GABA synthesis within the CNS. It also aids in the release of glycogen stored in the liver and muscles.

Vitamin B6 (pyridoxine) is a water-soluble vitamin used in the prophylaxis and treatment of vitamin B6 deficiency and peripheral neuropathy in those receiving isoniazid (isonicotinic acid hydrazide, INH). Vitamin B6 has been found to lower systolic and diastolic blood pressure in a small group of subjects with essential hypertension. Hypertension is another risk factor for atherosclerosis and coronary heart disease. Another study showed pyridoxine hydrochloride to inhibit ADP- or epinephrine-induced platelet aggregation and to lower total cholesterol levels and increase HDL-cholesterol levels, again in a small group of subjects. Vitamin B6, in the form of pyridoxal 5'-phosphate, was found to protect vascular endothelial cells in culture from injury by activated platelets. Endothelial injury and dysfunction are critical initiating events in the pathogenesis of atherosclerosis. Human studies have demonstrated that vitamin B6 deficiency affects cellular and humoral responses of the immune system. Vitamin B6 deficiency results in altered lymphocyte differentiation and maturation, reduced delayed-type hypersensitivity (DTH) responses, impaired antibody production, decreased lymphocyte proliferation and decreased interleukin (IL)-2 production, among other immunologic activities.

Sodium Acetate is chemically designated CH3COONa, a hygroscopic powder very soluble in water. Sodium acetate could be used as additives in food, industry, concrete manufacture, heating pads and in buffer solutions. Medically, sodium acetate is important component as an electrolyte replenisher when given intravenously. It is mainly indicated to correct sodium levels in hyponatremic patients. It can be used also in metabolic acidosis and for urine alkalinization.

Sodium is the principal cation of extracellular fluid. It comprises more than 90% of total cations at its normal plasma concentration of approximately 140 mEq/liter. The sodium ion exerts a primary role in controlling total body water and its distribution. Acetate ions acts as hydrogen ion acceptor which is alternative to bicarbonate.

A polyhydric alcohol with about half the sweetness of sucrose. Sorbitol occurs naturally and is also produced synthetically from glucose. It was formerly used as a diuretic and may still be used as a laxative and in irrigating solutions for some surgical procedures.

Calmin-600
Uses
Dosage
Side Effect
Precautions
Interactions
Uses during Pregnancy
Uses during Breastfeeding
Accute Overdose
Food Interaction
Half Life
Volume of Distribution
Clearance
Interaction With other Medicine
Contradiction
Storage

Trade Name	Calmin-600
Generic	Amino Acids + Magnesium Oxides and Hydroxides + Nicotinamide + Potassium Chloride + Pyridoxine + Riboflavin (Vitamin B2) + Sodium Acetate + Sorbitol
Weight	50g/l, 0.477g/l, 60mg/l, 1.863g/l, 40mg/l, 2.5mg/l, 2.87g/l, 100g/l
Type	Infusion
Therapeutic Class
Manufacturer	Sami Pharmaceuticals (pvt) Ltd,
Available Country	Pakistan
Last Updated:	September 19, 2023 at 7:00 am

Uses

Amino Acids is used for a source of amino acids for protein synthesis in patients needing intravenous nutrition. It is particularly suitable for a patient with basal amino acid requirements. Amino Acids is also used for faster recovery in surgery, burns, renal insufficiency, hepatic insufficiency and effective management of Cancer.

Nicotinamide is an ingredient found in a variety of cosmetic products.

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.

Pyridoxine (vitamin B6) is used to prevent or treat low levels of vitamin B6 in people who do not get enough of the vitamin from their diets. Most people who eat a normal diet do not need extra vitamin B6. However, some conditions (such as alcoholism, liver disease, overactive thyroid, heart failure) or medications (such as isoniazid, cycloserine, hydralazine, penicillamine) can cause low levels of vitamin B6. Vitamin B6 plays an important role in the body. It is needed to maintain the health of nerves, skin, and red blood cells.

Pyridoxine has been used to prevent or treat a certain nerve disorder (peripheral neuropathy) caused by certain medications (such as isoniazid). It has also been used to treat certain hereditary disorders (such as xanthurenic aciduria, hyperoxaluria, homocystinuria).

Sodium acetate is a compound used for electrolyte replenishment and total parenteral nutrition (TPN) therapy.

Injection, USP 40 mEq is indicated as a source of sodium, for addition to large volume intravenous fluids to prevent or correct hyponatremia in patients with restricted or no oral intake. It is also useful as an additive for preparing specific intravenous fluid formulas when the needs of the patient cannot be met by standard electrolyte or nutrient solutions. Sodium acetate and other bicarbonate precursors are alkalinising agents, and can be used to correct metabolic acidosis, or for alkalinisation of the urine.

Sorbitol is a product that can be used as a laxative to relieve constipation, and also as a urologic irrigating fluid. May also be used as a pharmaceutical sweetener.

Used as a non-stimulant laxative via an oral suspension or enema.

Calmin-600 is also used to associated treatment for these conditions: Creatinine Clearance 5-15 mL/min, Uremia, Nutritional Support, Parenteral Nutrition, Total parenteral nutrition therapyGastrointestinal insufficiency, Hepatic Insufficiency, Macrocytic anemia, Secondary anemia, Vitamin Deficiency, Severe debilitation, Dietary and Nutritional Therapies, Nutritional supplementation, Dietary supplementationDehydration, 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 therapyBackache, Dizziness, Fever, Headache, Hepatic; Functional Disturbance, Hepatitis, Iron Deficiency Anemia (IDA), Ketosis, Macrocytic anemia, Menière's Disease, Menstrual Distress (Dysmenorrhea), Metabolic Acidosis, Motion Sickness, Nausea and vomiting, Neuralgia, Sciatic, Neuritis, Neurological Conditions caused by B Vitamin Deficiency, Secondary anemia, Soreness, Muscle, Toothache, Toxinfectious state, Trigeminal Neuralgia (TN), Vitamin B1 deficiency, Vitamin B12 Deficiency, Vitamin B6 Deficiency, Vitamin Deficiency, Minor aches and pains, Minor pain, Nutritional supplementation, Supplementation, Vitamin supplementation, Wellness of the LiverHyponatremia, Hypovolaemia, Mild, moderate Metabolic Acidosis, Irrigation therapy, Nutritional supplementation, Oral rehydration therapy, Parenteral Nutrition, Parenteral rehydration therapy, Total parenteral nutrition therapy, Priming solution for infusionConstipation, Constipation caused by Pregnancy, Occasional Constipation, Bladder irrigation therapy, Bowel preparation therapy, Preparation for rectoscopic or sigmoidoscopic examination

How Calmin-600 works

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

Vitamin B6 is the collective term for a group of three related compounds, pyridoxine (PN), pyridoxal (PL) and pyridoxamine (PM), and their phosphorylated derivatives, pyridoxine 5'-phosphate (PNP), pyridoxal 5'-phosphate (PLP) and pyridoxamine 5'-phosphate (PMP). Although all six of these compounds should technically be referred to as vitamin B6, the term vitamin B6 is commonly used interchangeably with just one of them, pyridoxine. Vitamin B6, principally in its biologically active coenzyme form pyridoxal 5'-phosphate, is involved in a wide range of biochemical reactions, including the metabolism of amino acids and glycogen, the synthesis of nucleic acids, hemogloblin, sphingomyelin and other sphingolipids, and the synthesis of the neurotransmitters serotonin, dopamine, norepinephrine and gamma-aminobutyric acid (GABA).

It works as a source of sodium ions especially in cases of hyponatremic patients. Sodium has a primary role in regulating extracellular fluid volume. It controls water distribution, fluid and electrolyte balance and the osmotic pressure of body fluids. Sodium is also involved in nerve conduction, muscle contraction, acid-base balance and cell nutrient uptake.

Sorbitol exerts its laxative effect by drawing water into the large intestine, thereby stimulating bowel movements.

Dosage

Calmin-600 dosage

Adults:

The nitrogen requirement for maintenance of body protein mass depends on the patient's condition (nutritional state and degree of metabolic stress).

No or minor metabolic stress and normal nutritional state: 0.10-0.15 g nitrogen/kg/day,

Moderate metabolic stress with or without malnutrition: 0.15-0.20 g nitrogen/kg/day,

Severe catabolism as in burns, sepsis and trauma: up to 0.20-0.25 g nitrogen/kg/day.

The dosage range 0.10-0.25 g nitrogen/kg/day corresponds to 15-35 ml Amino Acids/kg/day.

In obese patients, the dose should be based on the estimated ideal weight. Depending upon patients requirements, 1000-2000 ml Amino Acids may be infused intravenously per 24 hours. Amino Acids should be infused slowly, at rates 1.4-2.8 ml (30-60 drops) per minute.

Infants and Children:

In children and infants, the rate of infusion is 28-35 ml/kg body wt/day is recommended, with a stepwise increment in the rate of administration during the first week of treatment.

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+

ADULTS:

BY MOUTH:

For hereditary sideroblastic anemia: Initially, 200-600 mg of vitamin B6 is used. The dose is decreased to 30-50 mg per day after an adequate response.
For vitamin B6 deficiency: In most adults, the typical dose is 2.5-25 mg daily for three weeks then 1.5-2.5 mg per day thereafter. In women taking birth control pills, the dose is 25-30 mg per day.
For abnormally high levels of homocysteine in the blood: For reducing high levels of homocysteine in the blood after childbirth, 50-200 mg of vitamin B6 has been taken alone. Also, 100 mg of vitamin B6 has been taken in combination with 0.5 mg of folic acid.
For preventing macular degeneration: 50 mg of vitamin B6 in the form of pyridoxine has been used daily in combination with 1000 mcg of vitamin B12 (cyanocobalamin) 1000 mcg and 2500 mcg of folic acid for about 7 years.
For hardening of the arteries (atherosclerosis): A specific supplement (Kyolic, Total Heart Health, Formula 108, Wakunga) containing 250 mg of aged garlic extract, 100 mcg of vitamin B12, 300 mcg of folic acid, 12.5 mg of vitamin B6, and 100 mg of L-argininedaily for 12 months.
For kidney stones: 25-500 mg of vitamin B6 has been used daily.
For nausea during pregnancy: 10-25 mg of vitamin B6 taken three or four times per day has been used. In people who don't respond to vitamin B6 alone, a combination product containing vitamin B6 and the drug doxylamine (Diclectin, Duchesnay Inc.) is used three or four times per day. Also, another product containing 75 mg of vitamin B6, 12 mcg of vitamin B12, 1 mg of folic acid, and 200 mg of calcium (PremesisRx, KV Pharmaceuticals) is used daily.
For symptoms of premenstrual syndrome (PMS): 50-100 mg of vitamin B6 is used daily, alone or along with 200 mg of magnesium.
For treating tardive dyskinesia: 100 mg of vitamin B6 per day has been increased weekly up to 400 mg per day, given in two divided doses.

INJECTED INTO THE MUSCLE:

Hereditary sideroblastic anemia: 250 mg of vitamin B6 daily, reduced to 250 mg of vitamin B6 weekly once adequate response is achieved.

CHILDREN:

BY MOUTH:

For kidney stones: Up to 20 mg/kg daily in children aged 5 years and up.

INJECTED INTO THE VEIN OR MUSCLE:

For seizures that respond to vitamin B6 (pyridoxine-dependent seizures): 10-100 mg is recommended.

The daily recommended dietary allowances (RDAs) of vitamin B6 are:

Infants 0-6 months, 0.1 mg
Infants 7-12 months, 0.3 mg
Children 1-3 years, 0.5 mg
Children 4-8 years, 0.6 mg
Children 9-13 years, 1 mg
Males 14-50 years, 1.3 mg
Males over 50 years, 1.7 mg
Females 14-18 years, 1.2 mg
Females 19-50 years, 1.3 mg
Females over 50 years, 1.5 mg
Pregnant women, 1.9 mg
Breast-feeding women, 2 mg
Some researchers think the RDA for women 19-50 years should be increased to 1.5-1.7 mg per day.

The recommended maximum daily intake is:

Children 1-3 years, 30 mg
Children 4-8 years, 40 mg
Children 9-13 years, 60 mg

Adults, pregnant and breast-feeding women:

14-18 years, 80 mg
over 18 years, 100 mg

Side Effects

Amino Acids is usually well tolerated. Yet nausea, vomiting, flushing and sweating have been observed during infusion of Amino Acids at rates exceeding the recommended maximal rate. Hypersensitivity reactions have been reported. Like all hypertonic infusion solution, thrombophlebitis may occur when peripheral veins are used. The incidence may be reduced by the simultaneous infusion of 10% fat emulsion. If it is infused to severely ill patients, premature infants, hyperphenylalaninemia may occur.

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.

Pyridoxine usually has no side effects when used in recommended doses.

If your doctor has prescribed this medication, remember that he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Pyridoxine can cause side effects when taken in large doses for a long time. Tell your doctor right away if any of these unlikely but serious side effects occur: headache, nausea, drowsiness, numbness/tingling of arms/legs.

A very serious allergic reaction to this drug is rare. However, seek immediate medical attention if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

Toxicity

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).

Oral Rat LD50 = 4 gm/kg. Toxic effects include convulsions, dyspnea, hypermotility, diarrhea, ataxia and muscle weakness.

LD50: 25956 mg/kg (Rat.)

Acute oral toxicity (LD50): 15900 mg/kg [Rat].

Precaution

Hyperphenylalaninemia has been noted in severely ill, premature infants. In these patients, monitoring of the phenylalanine levels is recommended and the infusion rate adjusted as needed.

Do not use if the solution is turbid or contains particles. Discard any unused portion.

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.

Before taking pyridoxine, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

During pregnancy, this vitamin has been found to be safe when used in recommended doses.

This vitamin passes into breast milk and is considered to be safe during breast-feeding when used in recommended doses. Consult your doctor for more information.

Interaction

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.

The effects of some drugs can change if you take other drugs or herbal products at the same time. This can increase your risk for serious side effects or may cause your medications not to work correctly. These drug interactions are possible, but do not always occur. Your doctor or pharmacist can often prevent or manage interactions by changing how you use your medications or by close monitoring.

To help your doctor and pharmacist give you the best care, be sure to tell your doctor and pharmacist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products) before starting treatment with this product. While using this product, do not start, stop, or change the dosage of any other medicines you are using without your doctor's approval.

Some products that may interact with this vitamin include: altretamine, cisplatin, phenytoin.

This vitamin may interfere with certain laboratory tests (including urine test for urobilinogen), possibly causing false test results. Make sure laboratory personnel and all your doctors know you use this vitamin.

Volume of Distribution

Pyridoxine main active metabolite, pyridoxal 5’-phosphate, is released into the circulation (accounting for at least 60% of circulating vitamin B6) and is highly protein bound, primarily to albumin.

Elimination Route

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.

The B vitamins are readily absorbed from the gastrointestinal tract, except in malabsorption syndromes. Pyridoxine is absorbed mainly in the jejunum. The Cmax of pyridoxine is achieved within 5.5 hours.

It is readily available in the circulation after IV administration.

Half Life

The total adult body pool consists of 16 to 25 mg of pyridoxine. Its half-life appears to be 15 to 20 days.

Elimination Route

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.

The major metabolite of pyridoxine, 4-pyridoxic acid, is inactive and is excreted in urine

Both the sodium and bicarbonate ions are excreted mainly in the urine. Some sodium is excreted in the feces, and small amounts may also be excreted in saliva, sweat, bile and pancreatic secretions.

Sorbitol will either be excreted in the urine by the kidneys, or metabolized to carbon dioxide and dextrose.

Pregnancy & Breastfeeding use

Successful and safe administration of amino acid solutions during pregnancy in the human has been reported. Animal reproduction studies have not been carried out with Amino Acids.

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.

Category A: Controlled studies in women fail to demonstrate a risk to the foetus in the 1st trimester (and there is no evidence of a risk in later trimesters), and the possibility of foetal harm remains remote.

Contraindication

Amino acid is contraindicated in patients with inborn errors of amino acids metabolism, irreversible liver damage and severe uremia when dialysis facilities are not available.

Hyperchloraemia, severe renal or adrenal insufficiency.

Special Warning

In children and infants, the rate of infusion is 28-35 ml/kg body weight per day is recommended, with a step wise increase in the rate of administration during the first week.