Doxiderm 5% Cream

Doxiderm is a tricyclic antidepressant. It is used in the treatment of insomnia (difficulty in sleeping). It is also used in patients intolerant of or unresponsive to alternative (other) treatment options for depression and anxiety disorders. Doxiderm works by increasing the levels of chemical messengers in the brain that stabilizes and enhances the mood. It is usually advised to take it before bedtime because it can make you feel drowsy. It can be taken with or without food, but you should take it at a fixed time each day for better efficacy. The dose and duration will be decided by your doctor so that you get the right amount to control your symptoms. If you have missed any dose, take it as soon as you remember it. Do not skip any dose and finish the full course of treatment even if you feel better. This medication must not be stopped suddenly without talking to the doctor. Your dose may be modified or gradually decreased before stopping the medicine. The most common side effects of this medicine include increased heart rate, blurred vision, dryness in the mouth, difficulty in urination and constipation. Initially, this medicine may also cause a sudden drop in the blood pressure, especially when you change positions. It may even cause dizziness and sleepiness, so do not drive or do anything that requires mental focus until you know how this medicine affects you. To lower the chances of dizziness, rise slowly if you have been sitting or lying down. It may also lead to weight gain in some people. Most of the common side effects tend to be mild and temporary. Your doctor may be able to suggest ways of preventing or reducing side effects if they bother you or do not go away. Serious side effects associated with this medicine are rare. Before taking this medicine, it is important to tell your doctor if you are taking or have recently taken any other medicines for the same or any other diseases. Pregnant and breastfeeding women should take this medicine with proper consultation and caution. This medicine is not known to be addictive, but you can experience additional side effects (withdrawal symptoms) if you stop taking it suddenly. If you notice any sudden mood change or get suicidal or self-harm thoughts, you must consult the doctor without delay. Also, remember to take this medicine as advised by the doctor as an overdose of this medication may lead to a serious health emergency. Consumption of alcohol should be avoided as alcohol interacts with this medicine to cause serious health issues.

Uses of Doxiderm

• Insomnia
• Depression
• Anxiety

Side effects of Doxiderm

Common

• Constipation
• Difficulty in urination
• Dryness in mouth
• Increased heart rate
• Orthostatic hypotension (sudden lowering of blood pressure on standing)
• Weight gain

How to use Doxiderm

Take this medicine in the dose and duration as advised by your doctor. Do not chew, crush or break it. Doxiderm may be taken with or without food, but it is better to take it at a fixed time.

How Doxiderm works

Doxiderm is a tricyclic antidepressant. It increases the levels of chemical messengers in the brain that help in regulating the mood and treat depression.

What if you forget to take Doxiderm?

If you miss a dose of Doxiderm, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular schedule. Do not double the dose.

Quick Tips

• Doxiderm helps in the treatment of insomnia, depression and anxiety.
• Inform your doctor if you notice behavioral changes, mood changes and suicidal thoughts while taking this medicine.
• Inform your doctor if you notice a loss of consciousness, agitation, reduced breathing rate, convulsions, muscle rigidity, and mouth dryness.
• You may be asked for regular blood tests to monitor the blood cell count or level of sodium and sugar in the blood.
• Do not drive or do anything that requires concentration until you know how the medicine affects you.
• Do not stop taking the medication suddenly without talking to your doctor.

Brief Description

Indication

Pruritus, Chronic idiopathic urticaria (hives), Atopic dermatitis, lichen simplex chronicus

Description
Doxepin hydrochloride is one of a class of agents known as dibenzoxepin tricyclic antidepressant compounds. Although doxepin HCl does have H1 and H2 histamine receptor blocking actions, the exact mechanism by which doxepin exerts its antipruritic effect is unknown. It can produce drowsiness in significant numbers of patients, and this sedation may reduce awareness, including awareness of pruritic symptoms.

Indications
Doxiderm cream is indicated for the short-term (upto 8 days) management of moderate pruritus in adult patients with atopic dermatitis or lichen simplex chronicus.

Dosage & Administration
Adult and child over 12 years: apply thinly 3–4 times daily; usual max. 3 g per application; usual total max. 12 g daily; coverage should be less than 10% of body surface area.
Use in Children:
The use of Doxiderm cream in pediatric patients is not recommended. Safe conditions for use of cream in children have not been established.
Use in Elderly Patients:
Dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal or cardiac function, and of concomitant disease or other drug therapy.

Side Effects
Drowsiness, local burning, stinging, irritation, tingling, rash; systemic side-effects such as antimuscarinic effects, headache, fever, dizziness, gastro-intestinal disturbances has been reported.

Precautions
Cautions should be exercised if there is susceptibility to angle-closure glaucoma, urinary retention, severe liver impairment, mania and also in pregnancy and breast-feeding. Drowsiness may affect performance of skilled tasks (e.g. driving) so patient should be careful.

Use in Pregnancy & Lactation
Pregnancy: Category B-There are no adequate and well-controlled studies in pregnant women. This drug should be used during pregnancy only if clearly needed.

Nursing Mothers: Doxepin is excreted in human milk after oral administration. It is possible that doxepin may also be excreted in human milk following topical application of Doxiderm cream.
Drug Interaction
Concomitant use of tricyclic antidepressants with drugs that can inhibit cytochrome P450 2D6 like MAO inhibitors, cimetidine, alcohol may require lower doses than usually prescribed for either the tricyclic antidepressant or the other drug. MAO inhibitors should be discontinued at least two weeks prior to the cautious initiation of therapy with Doxiderm cream.

Over Dose
If overdosage with topical application of Doxiderm cream occur, the signs and symptoms may include cardiac dysrhythmias, severe hypotension, convulsions, and CNS depression, including coma. Changes in the electrocardiogram, particularly in QRS axis or width, are clinically significant indicators of tricyclic antidepressant toxicity. Other signs of overdose may include confusion, disturbed concentration, transient visual hallucinations, dilated pupils, agitation, hyperactive reflexes, stupor, drowsiness, muscle rigidity, vomiting, hypothermia, hyperpyrexia.

Adult Dose

Adult: apply thinly 3-4 times daily; usual max. 3 g per application; usual total max. 12 g daily; coverage should be less than 10% of body surface area. Use in Elderly Patients: Dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range.

Child Dose

Child over 12 years: apply thinly 3-4 times daily; usual max. 3 g per application; usual total max. 12 g daily; coverage should be less than 10% of body surface area. The use of Doxepin cream in pediatric patients is not recommended.

Contraindication

Patients with untreated narrow angle glaucoma or a tendency to urinary retention because doxepin HCl has an anticholinergic effect Individuals who have shown previous sensitivity to any of its components

Mode of Action

Potent histamine H1- & H2-receptor antagonist activity.

Precaution

Cautions should be exercised if there is susceptibility to angle-closure glaucoma, urinary retention, severe liver impairment, mania and also in pregnancy and breast-feeding. Drowsiness may affect performance of skilled tasks (e.g. driving) so patient should be careful. Lactation: may pass into breast milk; do not nurse

Side Effect

>10% Burning/stinging (23%),Drowsiness (20%; esp if applied to >10% BSA) 1-10% Dizziness,Dry mouth,Eczema exacerbated,Edema,Fatigue,Mental changes,Pruritus,Taste perversion

Pregnancy Category Note

Pregnancy Category: B Lactation: May pass into breast milk; do not nurse

Interaction

Methylphenidate may increase plasma doxepin levels. Potentially Fatal: Potentiates hypertensive action of sympathomimetics. Increased anticholinergic effects with MAOIs. Additive CNS effects with anticholinergics, CNS depressants and alcohol.