ORALTEK¨ PERLINGUAL SPRAY Price

Overview

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This medicine contains an important and useful components, as it consists of
Allergen extract of Alternaria alternata Ph. Eur. is available in the market in concentration

Name

Citric Acid Monohydrate 5% + Potassium Citrate 30%

Precaution

Citric acid monohydrate 5% combined with potassium citrate 30% is commonly used in the treatment of urinary tract conditions, particularly for managing conditions related to kidney stones and maintaining urinary pH balance. Before initiating therapy, patients should be evaluated for any pre-existing renal issues, such as kidney disease or a history of renal failure, as potassium citrate may increase potassium levels in the blood (hyperkalemia), which can be dangerous in individuals with impaired kidney function. This combination product should also be used with caution in patients with conditions such as adrenal insufficiency, severe dehydration, or a history of gastrointestinal disorders, including peptic ulcers or gastritis, as citric acid can increase gastric acidity. Monitoring of potassium levels is recommended, especially in patients on other potassium-sparing medications or those taking ACE inhibitors, potassium supplements, or diuretics that retain potassium. In pregnant and breastfeeding women, citric acid and potassium citrate should only be used when the benefits outweigh potential risks, as there is limited data on their safety during these times. The patient should consult with a healthcare provider to ensure appropriate use in special populations, including those with diabetes, hypertension, or electrolyte imbalances.

Indication

The combination of citric acid monohydrate 5% and potassium citrate 30% is primarily used for the prevention and treatment of kidney stones, particularly those composed of uric acid or cystine. It works by alkalinizing the urine, which helps dissolve uric acid stones and prevents the formation of new stones. Additionally, potassium citrate helps to increase urinary pH, which can inhibit the crystallization of stone-forming salts. This therapy is often indicated for patients who are prone to recurrent kidney stones, especially when they have conditions such as hyperuricosuria or gout. The combination product is also used to prevent stone formation in patients with metabolic abnormalities, such as renal tubular acidosis. Off-label uses may include its application in patients with urinary tract infections (UTIs) to manage acidity levels in urine, although the evidence for this indication is less robust. The primary mechanism of action—alkalinizing the urine—is what makes this combination effective for a range of urinary-related conditions that involve pH imbalances and stone formation.

Contra indication

This combination product is contraindicated in patients with a known hypersensitivity to any of its components, including citric acid or potassium citrate. It should also be avoided in individuals with hyperkalemia (high potassium levels), as excessive potassium intake can lead to severe cardiovascular and muscular complications. Additionally, citric acid and potassium citrate should not be used in patients with acute or chronic renal failure or those with significantly impaired kidney function, as the kidneys may be unable to eliminate excess potassium, leading to dangerous levels in the blood. The product is contraindicated in individuals with conditions that predispose them to hyperkalemia, such as Addison’s disease or severe dehydration. It should not be used in those with a history of peptic ulcers or gastrointestinal bleeding, as citric acid may irritate the gastrointestinal tract. Patients with a history of potassium sensitivity or who are on medications that increase potassium levels, such as potassium-sparing diuretics, should avoid using this combination without close medical supervision.

Side Effect

The most common side effects associated with citric acid monohydrate 5% + potassium citrate 30% are gastrointestinal in nature, including nausea, bloating, or abdominal discomfort. Some patients may experience an upset stomach, indigestion, or a sour taste in the mouth due to the citric acid content. These effects are generally mild and can often be reduced by taking the medication with food or adjusting the dosage. In some cases, the medication may cause diarrhea, which could be a result of the alkalinizing effect on the digestive system. More serious, though less common, side effects include hyperkalemia (high potassium levels), which can lead to symptoms such as muscle weakness, fatigue, irregular heartbeat, and, in severe cases, cardiac arrest. Patients who develop any of these symptoms should seek immediate medical attention. Additionally, citric acid may irritate the stomach lining, leading to gastric discomfort or the potential for peptic ulcers, particularly in individuals with a history of gastritis or ulcers. Severe allergic reactions, including rash, swelling, or difficulty breathing, are rare but may occur in sensitive individuals. If any signs of an allergic reaction appear, the patient should discontinue use and consult a healthcare provider immediately.

Pregnancy Category ID

3

Mode of Action

The primary mode of action of citric acid monohydrate 5% + potassium citrate 30% is the alkalinization of urine, which helps prevent the formation of kidney stones and promotes the dissolution of uric acid stones. Citric acid, as an acidic compound, is metabolized in the body to form bicarbonate ions, which increase the pH of urine, making it more alkaline. The increased urinary pH reduces the likelihood of uric acid and calcium oxalate stones forming by inhibiting the crystallization of these salts. Potassium citrate plays a critical role by providing citrate ions, which bind to calcium in the urine, forming soluble calcium-citrate complexes and preventing calcium from combining with oxalate to form stones. This combination is particularly effective for preventing the formation of uric acid stones, as the alkalinizing effect helps to dissolve existing stones and prevent new ones from forming. By promoting a more favorable environment in the urinary system, the combination of citric acid and potassium citrate aids in reducing the frequency of stone formation in susceptible individuals, while also offering potential therapeutic benefits in patients with metabolic disorders like renal tubular acidosis.

Interaction

Citric acid monohydrate 5% + potassium citrate 30% may interact with several medications, particularly those that affect potassium levels or kidney function. Potassium-sparing diuretics, such as spironolactone or amiloride, may exacerbate the risk of hyperkalemia when used in combination with potassium citrate, so careful monitoring of potassium levels is recommended. Similarly, ACE inhibitors or angiotensin receptor blockers (ARBs), which are commonly used in the treatment of hypertension or heart failure, may also increase potassium levels, potentially leading to life-threatening hyperkalemia. Medications that affect renal function, such as nonsteroidal anti-inflammatory drugs (NSAIDs) or certain antibiotics (e.g., aminoglycosides), may also increase the risk of kidney toxicity when combined with this product. Alkalinizing agents like sodium bicarbonate or other forms of citrate could lead to additive effects, increasing the risk of metabolic alkalosis or electrolyte imbalances. Patients should avoid high-sodium diets, as excess sodium can counteract the effect of potassium citrate. Additionally, alcohol consumption may increase the risk of dehydration, which can exacerbate electrolyte imbalances, so moderation is recommended. Patients should consult their healthcare provider about potential drug interactions before starting this combination therapy.

Pregnancy Category Note

Information not available

Adult Dose

The standard dosage of citric acid monohydrate 5% + potassium citrate 30% for adults varies depending on the severity of the condition and individual patient response. The typical starting dose is 5 to 10 mL of the solution three times a day, administered orally. In some cases, the dose may be increased to up to 20 mL per dose, depending on the clinical need and tolerability. The total daily dose typically does not exceed 60 mL in divided doses. It is recommended to take the solution with food to reduce the risk of gastrointestinal irritation. The dosage may need to be adjusted based on urinary pH levels or potassium levels, as monitoring is essential for ensuring safe use. The product should be taken consistently to achieve and maintain the desired effects. For patients with renal impairment or those on medications that affect potassium levels, lower doses or careful monitoring may be required. It is crucial to follow the prescribing healthcare provider's instructions and regularly monitor blood potassium levels during therapy.

Child Dose

The use of citric acid monohydrate 5% + potassium citrate 30% in children should be approached with caution, and the dosage should be based on the child’s age, weight, and specific medical condition. Pediatric dosing is typically lower than the adult dose, and the drug should only be used in children under the supervision of a healthcare provider. In children, the starting dose usually ranges from 1 to 3 mL of the solution, administered two to three times a day. The dose may be gradually increased depending on the child's response and tolerance, but the total daily dose should not exceed 10–20 mL. Careful monitoring of potassium levels and renal function is essential, as children are more vulnerable to electrolyte imbalances. The safety and efficacy of this combination product in pediatric patients have not been well-studied, so it should only be prescribed when necessary, and under the guidance of a healthcare provider familiar with the child’s medical history.

Renal Dose

In patients with renal impairment, particularly those with chronic kidney disease or severe renal dysfunction, the use of citric acid monohydrate 5% + potassium citrate 30% requires careful consideration. Since citric acid and potassium citrate can affect electrolyte levels, particularly potassium, monitoring kidney function and serum potassium levels is essential in patients with reduced renal function. For those with mild renal impairment (creatinine clearance 60–90 mL/min), the standard dose may be used with periodic monitoring. However, for patients with moderate to severe renal impairment (creatinine clearance <60 mL/min), the dose should be reduced to avoid the risk of hyperkalemia, and more frequent monitoring is necessary. In patients with end-stage renal disease, the use of this product is generally contraindicated, as their kidneys are unable to adequately clear potassium, leading to a risk of dangerous potassium accumulation. Close supervision and regular blood tests are necessary to ensure safe use in those with renal impairment.

Administration

Information not available