Sorax

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.

Pseudoephedrine is a decongestant of the mucous membranes of the upper respiratory tract, especially the nasal mucosa, sinuses and eustachian tube. It is used for the symptomatic relief of allergic rhinitis (hay fever), vasomotor rhinitis, the common cold, influenza (flu) and ear congestion caused by ear inflammation or infection. Pseudoephedrine can also be used as a bronchodilator.

Pseudoephedrine is a stereoisomer of Ephedrine with similar but less potent pharmacological activity. It has nasal and bronchial decongestant activity.

Potassium bicarbonate is an ingredient used as an antacid or to treat hypokalemia.

Potassium bicarbonate is used as an antacid, electrolyte replenisher and potassium supplement. It can also be used as an excipient in drug formulations. An antacid is a medication used to neutralize gastric acid in a short timeframe after ingestion and the effect is soon overcome by meal-stimulated acid secretion.

Renal Tubular Acidosis (RTA) With Calcium Stones: Potassium citrate is used for the management of renal tubular acidosis

Hypocitraturic Calcium Oxalate Nephrolithiasis Of Any Etiology: Potassium citrate is used for the management of Hypocitraturic calcium oxalate nephrolithiasis

Uric Acid Lithiasis With Or Without Calcium Stones: Potassium citrate is used for the management of Uric acid lithiasis with or without calcium stones

Terpin hydrate is an expectorant used to treat bronchitis, pneumonia, bronchiectasis, COPD, and infectious or inflammatory diseases of the upper respiratory tract.

Terpin hydrate is used in the treatment of acute and chronic bronchitis, pneumonia, bronchiectasis, chronic obstructive pulmonary disease, infectious and inflammatory diseases of the upper respiratory tract.

Sorax 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, PotassiumAllergic Disorder, Bronchial Asthma, Common Cold, Cough, Depression, Fever, General Anesthesia Induced Hypotension, Headache, Joint Pain, Myasthenia Gravis, Narcolepsy, Nasal Congestion, Rhinorrhoea, Sore Throat, Dry coughArrhythmias Cardiac caused by Hypokalemia, Gastro-esophageal Reflux Disease (GERD), Hypocitraturia, Hypokalemia, Ketoacidosis caused by Hypokalemia, Kidney Stones, Neuromuscular Disorders caused by Hypokalemia, Uric Acid Stones, Calcium oxalate calculi Renal CalculiAcidosis, Renal Tubular, Bowel preparation therapy, Constipation, Hypocitraturic calcium oxalate nephrolithiasis, Kidney Stones, Metabolic Acidosis, Uremia, Uric Acid Nephrolithiasis, Chronic metabolic acidosis, Uric acid lithiasis, LaxativeCough caused by Common Cold, Coughing caused by Bronchitis, Rhinorrhoea, Airway secretion clearance therapy

How Sorax 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.

Ephedrine is a direct and indirect sympathomimetic amine. Ephedrine activates adrenergic α and β-receptors as well as inhibiting norepinephrine reuptake, and increasing the release of norepinephrine from vesicles in nerve cells. These actions combined lead to larger quantities of norepinephrine present in the synapse, for longer periods of time, increasing stimulation of the sympathetic nervous system. Ephedrine's stimulation of α-1 receptors causes constriction of veins and a rise in blood pressure, stimulation of β-1 adrenergic receptors increase cardiac chronotropy and inotropy, stimulation of β-2 adrenergic receptors causes bronchodilation.

The antacid potential of potassium bicarbonate is attained by increasing the gastrointestinal pH by neutralizing hydrochloric acid. The increase in pH results in suppression of the action of pepsin which is the enzyme that exacerbates ulceration due to the presence of acid.

After oral administration of potassium citrate, its metabolism yields alkaline load. Potassium Citrate therapy appears to increase urinary citrate mainly by modifying the renal handling of citrate, rather than by increasing the filtered load of citrate. In addition to raising urinary pH and citrate, Potassium Citrate increases urinary potassium by approximately the amount contained in the medication. In some patients, Potassium Citrate causes a transient reduction in urinary calcium.

Terpin hydrate improves mucociliary function by working directly on the bronchial secretory cells in the lower respiratory tract to liquify and facilitate the elimination of bronchial secretionsas well as exerting a weak antiseptic effect on the pulmonary parenchyma. It is thought to increase the amount of fluid in the respiratory tract, which increases the flow and clearance of local irritants and as well as reducing the viscosity of mucus .

Dosage

Sorax dosage

As a decongestant and symptomatic treatment for upper respiratory tract infections the recommended dose is:

Adults: 1 tablet every 4 to 6 hours, up to maximum of 240 mg in 24 hours

Children:

• 6-12 years of age: 1/2 tablet every 4 to 6 hours daily
• 2-5 years of age: 1/4 tablet every 4 to 6 hours daily
• Less than 2 years of age: This drug is not advised unless specifically recommended by a physician.

Dosing Instructions: Treatment with extended release potassium citrate should be added to a regimen that limits salt intake (avoidance of foods with high salt content and of added salt at the table) and encourages high fluid intake (urine volume should be at least two liters per day). Theobjectiveof treatment with Potassium Citrate is to provide Potassium Citrate in sufficient dosage to restore normal urinary citrate (greater than 320 mg/day and as close to the normal mean of 640 mg/day as possible), and to increase urinary pH to a level of 6.0 or 7.0.

Monitor serum electrolytes (sodium, potassium, chloride andcarbon dioxide), serum creatinine and complete blood counts every four months and more frequently in patients with cardiac disease, renal disease or acidosis. Perform electrocardiograms periodically. Treatment should be discontinued if there ishyperkalemia, a significant rise in serum creatinine or a significant fall in blood hemocrit orhemoglobin.

Severe Hypocitraturia: In patients with severe hypocitraturia (urinary citrate <150 mg/day), therapy should be initiated at a dosage of 60 mEq/day (30 mEq two times/day or 20 mEq three times/day with meals or within 30 minutes after meals or bedtime snack). Twenty-four hour urinary citrate and/or urinary pH measurements should be used to determine the adequacy of the initial dosage and to evaluate the effectiveness of any dosage change. In addition, urinary citrate and/or pH should be measured every four months. Doses of Potassium Citrate greater than 100 mEq/day have not been studied and should be avoided.

Mild To Moderate Hypocitraturia: In patients with mild to moderate hypocitraturia (urinary citrate > 150 mg/day) therapy should be initiated at 30 mEq/day (15 mEq two times/day or 10 mEq three times/day within 30 minutes after meals or bedtime snack). Twenty-four hour urinary citrate and/or urinary pH measurements should be used to determine the adequacy of the initial dosage and to evaluate the effectiveness of any dosage change. Doses of Potassium Citrate greater than 100 mEq/day have not been studied and should be avoided.

Side Effects

Serious adverse effects associated with the use of Pseudoephedrine are rare. Symptoms of central nervous system excitation may occur, including sleep disturbances and, rarely, hallucinations have been reported. Skin rashes, with or without irritation, have occasionally been reported.

Nausea, vomiting, diarrhea, and stomach pain may occur. Taking it after meals will help prevent these side effects. An empty tablet shell may appear in your stool. This is harmless because your body has already absorbed the medication.

This drug may cause serious stomach or intestinal problems (e.g., bleeding, blockage, puncture). This medication may cause high potassium levels in the blood (hyperkalemia). A very serious allergic reaction to this drug is rare.

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.

Patients experiencing an overdose of ephedrine will present with rapidly increasing blood pressure. Manage overdose with blood pressure monitoring, and possibly the administration of parenteral antihypertensives. The LD₅₀ in mice after oral administration is 785mg/kg, after intraperitoneal administration if 248mg/kg, and after subcutaneous administration is 425mg/kg.

Potassium bicarbonate does not contain any toxic chemicals and it is not listed as a carcinogenic or a potential carcinogen. Potassium bicarbonate is also considered safe in pregnancy as the current data do not suggest a teratogenic potential or any developmental toxicity.

LD50 (dog): Intravenous 176 mg/kg.

Overdose can cause nausea, vomiting and abdominal pain.

Precaution

Although Pseudoephedrine has virtually no pressor effects in normotensive patients, it should be used with caution in patients suffering mild to moderate hypertension. As with other sympathomimetic agents, Pseudoephedrine should be used with caution in patients with hypertension, heart disease, diabetes, hyperthyroidism, elevated intraocular pressure and prostatic enlargement. Caution should be exercised when using the product in the presence of severe hepatic impairment or moderate to severe renal impairment.

This medication should not be used ifpatient have (Addison's disease), current bladder infection, uncontrolled diabetes, severe heart disease (e.g., recent heart attack, heart damage), certain stomach/intestinal problems (diabetic gastroparesis, conditions decreasing gut movement, peptic ulcer, blockage), severe kidney disease (e.g., inability to make urine), potassium-restricted diet, high potassium levels, severe loss of body water (dehydration).

Before using this medication, tell your doctor or pharmacist your medical history, especially of: low calcium levels, severe diarrhea, heart problems (e.g., irregular heartbeat, heart failure), kidney disease, stomach/gut problems (e.g., irritable bowel), severe tissue damage (e.g., severe burns). Before having surgery, tell your doctor or dentist that you are taking this medication.

Volume of Distribution

Data not found.

Oral ephedrine has an average volume of distribution of 215.6L.

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.

Oral ephedrine reaches an average C_max of 79.5ng/mL, with a T_max of 1.81h, and a bioavailability of 88%.

Potassium bicarbonate intake is done mainly in the small intestine in which approximately 90% of the potassium will be absorbed by passive diffusion.

Half Life

Unknown

Oral ephedrine has a plasma elimination half life of approximately 6 hours, but there is a large degree of inter-patient variability.

Some reports have shown that after absorption, most body potassium exchanges rapidly with a half-life of less than 7 hours.

Clearance

Data not found.

Oral ephedrine has a clearance of 23.3L/h but there is a high degree of inter-patient variability.

Elimination Route

Excretion: Urine

Ephedrine is mainly eliminated in the urine. Approximately 60% is eliminated as the unmetabolized parent compound, 13% as benzoic acid conjugates, and 1% as 1,2-dihydroxypropylbenzene.

Approximately 90% of the exogenous potassium consumed is lost in the urine while the other 10% is excreted in feces and a very small amount can be found in the sweat. The excreted potassium is freely filtered by the glomerulus of the kidney.

Urinary; less than 5% unchanged.

Pregnancy & Breastfeeding use

Although Pseudoephedrine has been in widespread use for many years without apparent ill consequence, there are no specific data on its use during pregnancy. Caution should therefore be exercised by balancing the potential benefit of treatment to the mother against any possible hazards to the developing foetus. Pseudoephedrine is excreted in breast milk in small amounts but the effect of this on breast-fed infants is not known.

Pregnancy Category C. Animal reproduction studies have not been conducted. It is also not known whether Potassium Citrate can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Potassium Citrate should be given to a pregnant woman only if clearly needed.

Nursing Mothers: The normal potassium ion content of human milk is about 13 mEq/L. It is not known if Potassium Citrate has an effect on this content. Potassium Citrate should be given to a woman who is breast feeding only if clearly needed.

Contraindication

Pseudoephedrine is contraindicated in-

• Hypersensitivity of individuals to this drug
• Severe hypertension and coronary artery disease
• Concurrent use of Mono Amine Oxidase Inhibitor (MAOI) drugs

Potassium Citrate is contraindicated:

• In patients with hyperkalemia (or who have conditions pre-disposing them to hyperkalemia), as a further rise in serum potassium concentration may produce cardiac arrest. Such conditions include: chronic renal failure, uncontrolled diabetes mellitus, acute dehydration, strenuous physical exercise in unconditioned individuals, adrenal insufficiency, extensive tissue breakdown or the administration of a potassium-sparing agent (such as triamterene, spironolactone or amiloride).
• In patients in whom there is cause for arrest or delay in tablet passage through the gastrointestinal tract, such as those suffering from delayed gastric emptying, esophageal compression, intestinal obstruction or stricture, or those taking anticholinergic medication.
• In patients with peptic ulcer disease because of its ulcerogenic potential.
• In patients with active urinary tract infection (with either urea-splitting or other organisms, in association with either calcium or struvite stones). The ability of Potassium Citrate to increase urinary citrate may be attenuated by bacterial enzymatic degradation of citrate. Moreover, the rise in urinary pH resulting from Potassium Citrate therapy might promote further bacterial growth.
• In patients with renal insufficiency (glomerular filtration rate of less than 0.7 ml/kg/min), because of the danger of soft tissue calcification and increased risk for the development of hyperkalemia.

Special Warning

Pediatric Use: Safety and effectiveness in children have not been established.

Acute Overdose

As with other sympathomimetic agents, symptoms of overdosage include irritability, restlessness, tremor, convulsions, palpitations, hypertension and difficulty in micturition. Necessary measures should be taken to maintain and support respiration and control convulsions. Gastric lavage should be performed if indicated. If desired, the elimination of Pseudoephedrine can be accelerated by acid diuresis or by dialysis.

Treatment Of Overdosage: The administration of potassium salts to persons without predisposing conditions for hyperkalemia rarely causes serious hyperkalemia at recommended dosages. It is important to recognize that hyperkalemia is usually asymptomatic and may be manifested only by an increased serum potassium concentration and characteristic electrocardiographic changes (peaking of T-wave, 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.

Treatment measures for hyperkalemia include the following:

• Patients should be closely monitored for arrhythmias and electrolyte changes.
• Elimination of medications containing potassium and of agents with potassium-sparing properties such as potassium-sparing diuretics, ARBs, ACE inhibitors, NSAIDs, certain nutritional supplements and many others.
• Elimination of foods containing high levels of potassium such as almonds, apricots, bananas, beans (lima, pinto, white), cantaloupe, carrot juice (canned), figs, grapefruit juice, halibut, milk, oat bran, potato (with skin), salmon, spinach, tuna and many others.
• Intravenous calcium gluconate if the patient is at no risk or low risk of developing digitalis toxicity.
• Intravenous administration of 300-500 mL/hr of 10% dextrose solution containing 10-20 units of crystalline insulin per 1,000 mL.
• Correction of acidosis, if present, with intravenous sodium bicarbonate.
• Hemodialysis or peritoneal dialysis.
• Exchange resins may be used. However, this measure alone is not sufficient for the acute treatment of hyperkalemia.

Lowering potassium levels too rapidly in patients taking digitalis can produce digitalis toxicity.

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