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Overview

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This medicine contains an important and useful components, as it consists of
Aluminium OH, Liquorice extract, Magnesium carbonate, Sodium bicarbonateis available in the market in concentration

Name

Doxepin

Precaution

Doxepin is a tricyclic antidepressant (TCA) that requires cautious use in certain populations. It should be used with care in patients with a history of heart disease, including arrhythmias, as TCAs can prolong the QT interval and increase the risk of fatal arrhythmias. Doxepin can also lower the seizure threshold, so patients with a history of seizures or those at increased risk should be monitored closely. Caution is also advised in patients with a history of glaucoma, urinary retention, or prostatic hypertrophy, as doxepin has anticholinergic properties that can exacerbate these conditions by causing urinary retention or increased intraocular pressure. In elderly patients, the risk of sedation, orthostatic hypotension, and confusion may be higher, so a lower starting dose should be considered, with gradual titration. Doxepin is contraindicated in patients who are currently taking monoamine oxidase inhibitors (MAOIs) or have taken them within the past 14 days, as this combination can result in severe hypertension and potentially fatal interactions. Pregnant women should use doxepin only if the benefits outweigh the risks, as it is classified as a Category C drug during pregnancy. Doxepin passes into breast milk, so it should be used cautiously in breastfeeding women. Regular monitoring of patients on long-term therapy is recommended to assess for side effects like changes in mood, worsening depression, suicidal ideation, or cardiac arrhythmias. Doxepin also has a potential for misuse in patients with a history of substance use disorders, particularly for its sedative effects.

Indication

Doxepin is primarily indicated for the treatment of major depressive disorder (MDD) and anxiety disorders, including generalized anxiety disorder (GAD) and panic disorder. It works by increasing the levels of neurotransmitters like serotonin and norepinephrine in the brain, which are thought to be low in individuals with depression or anxiety. Doxepin is also approved for the treatment of insomnia, particularly for individuals who have trouble staying asleep due to its sedative effects. Off-label uses include the management of chronic pain conditions, such as fibromyalgia or neuropathic pain, as well as for the treatment of pruritus (itching) associated with dermatologic conditions like eczema or psoriasis. It may also be used in the management of post-traumatic stress disorder (PTSD), though its efficacy for this condition is less well established compared to other therapeutic agents.

Contra indication

Doxepin is contraindicated in patients with a known hypersensitivity to the drug or its components, as well as in individuals with a history of severe cardiovascular conditions, including recent myocardial infarction (MI) or arrhythmias. It is also contraindicated in patients with angle-closure glaucoma due to its anticholinergic effects, which can increase intraocular pressure. Patients taking monoamine oxidase inhibitors (MAOIs) should avoid doxepin for at least 14 days after discontinuing an MAOI, as this combination can cause severe, life-threatening reactions such as hypertensive crises. Doxepin is also contraindicated in patients with urinary retention, particularly those with benign prostatic hyperplasia, as it can worsen symptoms of urinary retention. The drug should not be used in patients with a history of seizures or those at risk for seizures, as it can lower the seizure threshold. Age-related factors must be considered, as elderly patients may be more sensitive to the anticholinergic and sedative effects, and the risk of side effects may be increased.

Side Effect

Common side effects of doxepin include sedation, dry mouth, constipation, urinary retention, and blurred vision, which are primarily attributed to its anticholinergic properties. These side effects are more likely to occur at higher doses and can significantly impair a patient's quality of life. Patients should be advised to avoid activities requiring mental alertness, such as driving or operating heavy machinery, until they understand how the medication affects them. Less common side effects include weight gain, dizziness, orthostatic hypotension, and sexual dysfunction. Doxepin may also cause confusion or cognitive impairment, particularly in older adults, and should be used with caution in these patients. Serious but rare side effects include seizures, cardiac arrhythmias, particularly those related to QT interval prolongation, and an increased risk of suicidal thoughts or behavior, especially in young adults and adolescents. Long-term use of doxepin may lead to tolerance or physical dependence in some individuals, particularly when used for insomnia. To mitigate side effects, dose adjustments, slower titration, and careful monitoring of renal and hepatic function may be required, especially in the elderly or those with comorbid conditions.

Pregnancy Category ID

0

Mode of Action

Doxepin is a tricyclic antidepressant (TCA) that exerts its therapeutic effects through the inhibition of the reuptake of serotonin and norepinephrine in the brain, thereby increasing the levels of these neurotransmitters in the synaptic cleft. This results in improved mood and reduced symptoms of depression and anxiety. Doxepin also has some antagonistic effects on histamine (H1) and acetylcholine receptors, which contribute to its sedative and anticholinergic properties. At low to moderate doses, doxepin primarily exerts its antidepressant and anxiolytic effects by modulating serotonin and norepinephrine. At higher doses, its sedative effects are more pronounced, which is why it is also used for the treatment of insomnia. The mechanism by which doxepin improves sleep is not fully understood but may be related to its ability to block histamine receptors, resulting in a sedative effect that promotes sleep. Pharmacokinetically, doxepin is well absorbed after oral administration, and it is extensively metabolized by the liver. It has a relatively long half-life, allowing for once-daily dosing in many patients. The drug is metabolized by cytochrome P450 enzymes, particularly CYP2D6, and its metabolism can be affected by the presence of inhibitors or inducers of these enzymes.

Interaction

Doxepin has several significant drug-drug interactions that must be carefully managed. When used with other central nervous system (CNS) depressants, such as alcohol, benzodiazepines, or opioids, there is an increased risk of sedation, respiratory depression, and overdose. The combination with other antidepressants, particularly selective serotonin reuptake inhibitors (SSRIs) or monoamine oxidase inhibitors (MAOIs), can lead to serotonin syndrome, a potentially fatal condition marked by agitation, confusion, hyperreflexia, and autonomic dysfunction. The combination of doxepin with other QT-prolonging drugs (such as certain antipsychotics, antiarrhythmics, or antihistamines) increases the risk of serious cardiac arrhythmias. Caution should be exercised when coadministering doxepin with drugs that affect cytochrome P450 enzymes, especially CYP2D6 inhibitors, as they may increase doxepin’s concentration, leading to toxicity. Additionally, doxepin can interact with antihypertensive drugs, potentially causing excessive hypotension, particularly in elderly patients or those on concurrent medications that lower blood pressure. It may also interact with anticholinergic drugs, increasing the risk of side effects such as dry mouth, constipation, urinary retention, and blurred vision.

Pregnancy Category Note

Information not available

Adult Dose

The typical starting dose for depression and anxiety in adults is 25 to 50 mg daily, taken at bedtime due to its sedative effects. The dose can be gradually increased based on patient response and tolerance, up to a maximum of 150 mg per day for depression and anxiety. For insomnia, lower doses are typically effective, with the usual dose ranging from 6 to 25 mg taken at bedtime. For patients with liver or renal impairment, a lower starting dose and slower titration may be required to avoid toxicity. Elderly patients are particularly sensitive to the sedative effects and may require dose reductions to prevent excessive sedation and dizziness. It is important to adjust the dose based on the patient's response to therapy, ensuring that both therapeutic effects and side effects are appropriately managed.

Child Dose

Doxepin is not typically recommended for pediatric patients, as safety and efficacy have not been well established in children under the age of 12. For adolescents (ages 12 to 18), the starting dose for depression or anxiety may range from 25 to 50 mg per day, with gradual increases based on response. For insomnia in children and adolescents, the dose should be reduced, and treatment should be initiated at the lowest effective dose. Long-term safety, particularly regarding growth and development, should be monitored carefully, and pediatric patients should be evaluated for any signs of mood changes, suicidal thoughts, or behavior.

Renal Dose

In patients with renal impairment, doxepin should be used with caution. Since doxepin is metabolized by the liver, the risk of toxicity is lower in those with renal dysfunction, but reduced renal clearance may lead to prolonged drug effects. For patients with moderate to severe renal impairment, the dose should be reduced, and careful monitoring of renal and hepatic function is necessary. The starting dose should be lower, and the dose should be titrated cautiously based on therapeutic response.

Administration

Information not available