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Overview

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This medicine contains an important and useful components, as it consists of
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Name

Glyceryl Trinitrate 0.4% (nitroglycerine) Rectal prep

Precaution

Glyceryl trinitrate 0.4% rectal preparation is commonly used in the treatment of anal fissures and as an adjunctive therapy for conditions like chronic anal pain or hemorrhoidal disease. Although it is effective in these areas, it comes with certain precautions. Patients should exercise caution if they have a history of cardiovascular disease, including hypotension (low blood pressure), as glyceryl trinitrate can cause systemic vasodilation, leading to a decrease in blood pressure. It is also important to monitor for symptoms of lightheadedness, dizziness, or fainting, especially during the initiation of treatment or dose adjustments. Pregnant or breastfeeding women should use this medication only if the benefits outweigh the risks, as its safety during pregnancy has not been fully established. This preparation should also be avoided in patients who are allergic to any components of the formulation. Due to the systemic absorption of glyceryl trinitrate, patients with a history of head trauma or stroke should be cautious when using this medication, as it may increase intracranial pressure. Additionally, patients with severe anemia, glaucoma, or dehydration should avoid using nitroglycerin unless under medical supervision. As tolerance may develop with prolonged use, cycling or adjusting the dose may be necessary to maintain efficacy.

Indication

The primary indication for glyceryl trinitrate 0.4% rectal preparation is the treatment of anal fissures, which are painful tears or cracks in the skin around the anus. Nitroglycerin works by relaxing the anal sphincter muscle, which reduces anal pressure and promotes healing of the fissure. The reduction in sphincter tone also helps to alleviate the pain associated with these tears, thereby improving quality of life for affected individuals. This medication may also be used off-label to treat other conditions related to rectal discomfort, such as chronic anal pain or hemorrhoidal disease, though this is less common. In these cases, it may provide relief by promoting vasodilation and improving blood flow to the affected area. Glyceryl trinitrate has a potent effect in relaxing smooth muscles and dilating blood vessels, which can also be beneficial in reducing symptoms of acute anal spasms. However, its use in conditions other than anal fissures is typically determined by a healthcare provider, and there are limited studies supporting its off-label application.

Contra indication

Glyceryl trinitrate 0.4% rectal preparation is contraindicated in patients with known hypersensitivity to nitroglycerin or any of the excipients in the formulation. It should not be used in individuals with a history of severe hypotension, as the vasodilatory effects of glyceryl trinitrate can significantly lower blood pressure. This preparation is also contraindicated in patients with head trauma, intracranial hemorrhage, or increased intracranial pressure, as it may exacerbate these conditions. Additionally, glyceryl trinitrate should be avoided in individuals with severe anemia, as it could worsen the oxygen-carrying capacity of the blood. The use of this medication in conjunction with other nitrates or phosphodiesterase type 5 inhibitors (e.g., sildenafil, tadalafil) is also contraindicated, as the combination can cause a dangerous drop in blood pressure. This formulation should be avoided in children under 18 years of age unless specifically prescribed by a healthcare provider, as there is limited evidence on its safety and efficacy in pediatric patients. Caution is also warranted in patients with glaucoma, dehydration, or other conditions that affect blood pressure regulation.

Side Effect

The most common side effects of glyceryl trinitrate 0.4% rectal preparation include headaches, which result from the vasodilation of blood vessels, and mild dizziness or lightheadedness due to the blood pressure-lowering effects of the drug. These side effects are typically more pronounced at the beginning of treatment and may diminish over time as the body adjusts to the medication. Some individuals may also experience local irritation or discomfort at the application site, including a burning or tingling sensation. Rarely, patients may experience more severe reactions such as fainting, severe dizziness, or persistent headaches. Other possible side effects include nausea, flushing, and palpitations (increased heart rate). These effects are usually transient but should be monitored, especially in patients who are prone to hypotension or who are using other blood pressure-lowering medications. In the case of severe side effects, such as prolonged dizziness, severe headaches, or fainting, patients should seek medical attention immediately. To reduce the risk of side effects, patients are often advised to begin treatment with lower doses and titrate up gradually. It is also essential to avoid excessive use, as prolonged application may increase the risk of tolerance and diminished therapeutic effect.

Pregnancy Category ID

3

Mode of Action

Glyceryl trinitrate exerts its therapeutic effects by releasing nitric oxide (NO) upon absorption into the body. Nitric oxide activates the enzyme guanylate cyclase in vascular smooth muscle cells, leading to the production of cyclic GMP (cGMP). This increase in cGMP causes the smooth muscle cells to relax, resulting in the dilation of blood vessels. When applied rectally, glyceryl trinitrate primarily targets the anal sphincter muscle, reducing its tone and alleviating spasm and pressure. This action is particularly beneficial in conditions like anal fissures, where increased sphincter pressure contributes to pain and impaired healing. The relaxation of the anal sphincter allows for improved blood flow to the area, which facilitates healing and reduces the pain associated with anal fissures. Additionally, the vasodilation induced by glyceryl trinitrate improves circulation and oxygen delivery to tissues, further promoting the healing of damaged areas. The systemic vasodilatory effects of the drug can also reduce the preload and afterload on the heart, improving overall circulatory function, though this is more of an indirect effect in rectal applications. Overall, nitroglycerin’s action provides significant relief in conditions where smooth muscle relaxation and improved blood flow are desired.

Interaction

Glyceryl trinitrate 0.4% rectal preparation can interact with a variety of medications, particularly those that affect blood pressure. Concurrent use with phosphodiesterase type 5 inhibitors (e.g., sildenafil, tadalafil, vardenafil), commonly used for erectile dysfunction, can lead to a severe and dangerous reduction in blood pressure, resulting in dizziness, fainting, and potential cardiovascular collapse. To avoid this interaction, at least 24 hours should elapse between the use of glyceryl trinitrate and these medications. Other antihypertensive drugs, such as beta-blockers, calcium channel blockers, or ACE inhibitors, can amplify the blood pressure-lowering effects of nitroglycerin, increasing the risk of hypotension, dizziness, and fainting. Alcohol consumption can also potentiate the hypotensive effects of glyceryl trinitrate, so it is advised to avoid alcohol while using this medication. The combination of nitroglycerin with other nitrates, either oral or topical, should be avoided to prevent excessive vasodilation and risk of severe hypotension. Additionally, glyceryl trinitrate may interact with certain antidepressants, antihistamines, and narcotic pain relievers, all of which could exacerbate the vasodilatory effects and contribute to dizziness, fainting, or other systemic symptoms. As with all medications, patients should inform their healthcare provider of all current medications, including over-the-counter drugs, to ensure safe and effective treatment.

Pregnancy Category Note

Information not available

Adult Dose

The standard adult dose of glyceryl trinitrate 0.4% rectal preparation is typically applied to the anal region two to three times a day, depending on the severity of the condition. A small amount of the ointment is usually applied directly to the affected area (e.g., anal fissures) using a clean finger or an applicator. The dose can be adjusted based on the patient’s response to treatment, with the goal of reducing pain and promoting healing. Treatment duration typically lasts for several weeks, and patients should be monitored for side effects such as headache or dizziness. If there is no improvement in symptoms or if side effects become intolerable, the treatment should be reassessed by a healthcare provider. For patients with significant discomfort, glyceryl trinitrate may be used in conjunction with other therapies, such as stool softeners or topical anesthetics, to provide comprehensive relief from anal fissures or hemorrhoidal pain. It is important to avoid using excessive amounts of the preparation to prevent systemic side effects like hypotension or tolerance to the drug.

Child Dose

The use of glyceryl trinitrate 0.4% rectal preparation in pediatric patients is not well-studied, and there are limited data on its safety and efficacy in children. Therefore, its use in children should be avoided unless prescribed by a healthcare provider with expertise in pediatric care. If used in children for conditions like anal fissures, the dosage would likely be adjusted based on the child’s weight and severity of symptoms, but specific dosing guidelines are lacking. Pediatric patients are generally more susceptible to systemic side effects, such as hypotension, dizziness, and fainting, so careful monitoring is essential if the drug is used. Parents and caregivers should ensure that any rectal preparation is applied correctly and in appropriate doses to avoid adverse effects, and the treatment should be discontinued if side effects occur. As with all medications, it is essential to consult with a healthcare provider before starting treatment in children.

Renal Dose

Glyceryl trinitrate 0.4% rectal preparation is minimally absorbed systemically when applied topically, which means that there is no significant renal dosing adjustment required for patients with renal impairment. Since the drug is primarily metabolized in the liver, renal dysfunction does not substantially affect its pharmacokinetics. However, patients with severe renal impairment should be monitored for signs of dehydration or electrolyte imbalances, particularly if they are using other medications that may affect fluid balance or blood pressure. As glyceryl trinitrate has a vasodilatory effect that may lower blood pressure, careful monitoring of renal function and blood pressure is recommended for patients with existing renal disease, especially those on dialysis or with end-stage renal disease.

Administration

Information not available