Prudoxin

Drowsiness occurs in over 20% of patients treated with Doxepin HCl Cream 5%, especially in patients receiving treatment to greater than 10% of their body surface area. Patients should be warned of this possibility and cautioned against driving a motor vehicle or operating hazardous machinery while being treated with PRUDOXIN (doxepin) Cream. Patients should also be warned that the effects of alcoholic beverages can be potentiated when using PRUDOXIN (doxepin) Cream. If excessive drowsiness occurs it may be necessary to reduce the number of applications, the amount of cream applied, and/or the percentage of body surface area treated, or discontinue the drug.

Keep this product away from the eyes.

Oral:

• Common side effects of doxepin include sleepiness, nausea and upset stomach.

Topical:

• Common side effects of doxepin cream include burning or stinging at site of application, dry mouth, and drowsiness.

Tell your healthcare provider if you have any side effect that bothers you or that does not go away.

These are not all the possible side effects of doxepin. For more information ask your healthcare provider or pharmacist. Call your doctor for medical advice about side effects.

Medicines can interact with certain foods. In some cases, this may be harmful and your doctor may advise you to avoid certain foods. In the case of doxepin there are no specific foods that you must exclude from your diet when receiving doxepin.

Oral:

• Tablets
  • Starting dose: 6 mg, once daily for adults and 3 mg, once daily for the elderly.
  • Take within 30 minutes of bedtime. Total daily dose should not exceed 6 mg.
  • Should not be taken within 3 hours of a meal.
• Capsules and Oral Solution
  • For most patients, a starting daily dose of 75 mg is recommended. Dosage may be increased or decreased at appropriate intervals and according to dose response. The usual dose range is 75 mg/day to 150 mg/day.
  • In more severely ill patients higher doses may be required with a gradual increase to 300 mg/day if necessary.
  • In patients with very mild symptoms, some patients may be on doses as low as 25-50 mg/day.
  • The total daily dosage of doxepin capsules may be given on a divided or once-a-day dosage schedule. If the once-a-day schedule is employed, the maximum recommended dose is 150 mg/day. This dose may be given at bedtime. The 150 mg capsule strength is not recommended for starting treatment.
  • Anti-anxiety effect will be seen before the antidepressant effect. The antidepressant effect may take 2 to 3 weeks to occur.

Topical:

• A thin film of doxepin cream should be applied four times each day with at least a 3 to 4 hour interval between applications. There are no data to establish the safety and effectiveness of doxepin cream when used for greater than 8 days. Use beyond eight days should be avoided. Use of doxepin cream for longer than 8 days may result in an increased likelihood of a hypersensitivity reaction.

Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Although the risk of serious side effects is low when doxepin topical is applied to the skin, side effects can occur if the medicine is absorbed into your bloodstream. You may feel drowsy after applying this medicine, especially if you have treated large areas of skin.

Stop using doxepin topical and call your doctor at once if you have:

• severe drowsiness;
• confusion;
• severe dry mouth;
• painful or difficult urination;
• blurred vision; or
• new or worsening skin symptoms.

Some side effects may be more likely in older adults.

Common side effects may include:

• burning or stinging where the medicine was applied;
• mild drowsiness; or
• dry mouth.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Serious overdose symptoms can occur if too much of this medicine is absorbed through your skin. Overdose symptoms may include extreme dizziness or drowsiness, feeling hot or cold, vomiting, confusion, agitation, trouble concentrating, irregular heartbeats, hallucinations, fainting, dilated pupils, muscle stiffness, or seizure (convulsions).

• Store at room temperature.
• Keep all drugs in a safe place. Keep all drugs out of the reach of children and pets.
• Check with your pharmacist about how to throw out unused drugs.

A thin film of Prudoxin Cream should be applied four times each day with at least a 3 to 4 hour interval between applications. There are no data to establish the safety and effectiveness of Prudoxin Cream when used for greater than 8 days. Chronic use beyond eight days may result in higher systemic levels and should be avoided. Use of Prudoxin Cream for longer than 8 days may result in an increased likelihood of contact sensitization.

The risk for sedation may increase with greater body surface area application of Prudoxin Cream (See WARNINGS section). Clinical experience has shown that drowsiness is significantly more common in patients applying Prudoxin Cream to over 10% of body surface area; therefore, patients with greater than 10% of body surface area (see WARNINGS section) affected should be particularly cautioned concerning possible drowsiness and other systemic adverse effects of doxepin. If excessive drowsiness occurs, it may be necessary to do one or more of the following: reduce the body surface area treated, reduce the number of applications per day, reduce the amount of cream applied, or discontinue the drug.

Occlusive dressings may increase the absorption of most topical drugs; therefore, occlusive dressings should not be utilized with Prudoxin Cream.

Common side effects of Prudoxin include: application site reaction and drowsiness. See below for a comprehensive list of adverse effects.

Applies to doxepin topical: topical cream

Local

Very common (10% or more): Burning/stinging (23%)
Common (1% to 10%): Other application site reaction
Frequency not reported: Irritation, tingling[Ref]

Nervous system

Very common (10% or more): Drowsiness (up to 22%)
Common (1% to 10%): Dizziness, taste perversion
Uncommon (0.1% to 1%): Headache
Frequency not reported: Lightheadedness, taste bitter, taste metallic[Ref]

Gastrointestinal

Common (1% to 10%): Dry mouth
Uncommon (0.1% to 1%): Numbness of tongue, nausea
Frequency not reported: Dry lips, dry throat, thirst, indigestion, vomiting, diarrhea, constipation[Ref]

Dermatologic

Common (1% to 10%): Pruritus, eczema exacerbated
Frequency not reported: Localized rash, pruritus exacerbated
Postmarketing reports: Allergic contact dermatitis[Ref]

General

The most frequently reported adverse effects were drowsiness and burning/stinging at application site.[Ref]

Genitourinary

Frequency not reported: Urinary retention[Ref]

Hypersensitivity

Frequency not reported: Type IV hypersensitivity reaction[Ref]

Ocular

Frequency not reported: Blurred vision, dry eyes[Ref]

Other

Common (1% to 10%): Fatigue/tiredness, edema
Uncommon (0.1% to 1%): Fever
Frequency not reported: Vertigo[Ref]

Psychiatric

Common (1% to 10%): Mental emotional changes
Uncommon (0.1% to 1%): Nervousness/anxiety[Ref]

Some side effects of Prudoxin may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.