Zonalon

Zonalon cream is a prescription medication used to treat itching of the skin. Zonalon belongs to a class of medications called antipruritics. These work by blocking histamine. Histamine is a substance that causes itchiness, redness, and general allergic reactions.

The cream form is to be applied to the affected area 4 times each day with at least a 3 to 4 hour interval between applications.

Common side effects of Zonalon cream include burning or stinging at site of application.

This medication may cause drowsiness. Do not drive or operate heavy machinery until you know how Zonalon affects you.

Oral:

• Doxepin is a prescription medication used to treat adults who are having difficulty staying asleep.

Topical:

• Doxepin cream is a prescription medication used to treat itching of the skin.

This medication may be prescribed for other uses. Ask your doctor or pharmacist for more information.

• Doak Dermatologics

• Lake Erie Medical Surgical & Supply DBA Quality Care Products LLC

• PharmaDerm, A division of Fougera Pharmaceuticals Inc.

• Quality Care Products, LLC

• Sandoz Inc.

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.

Tell your doctor about all of the medicines you take including prescription and nonprescription medicines, vitamins and herbal supplements.

Doxepin and other medicines may affect each other causing side effects. Doxepin may affect the way other medicines work, and other medicines may affects how doxepin works. Especially tell your healthcare provider if you take:

• a monoamine oxidase inhibitor (MAOI). 
• cimetidine (Tagamet) or other medicines that can affect certain liver enzymes
• certain allergy medicines (antihistamines) or other medicines that can make you sleepy or affect your breathing
• the diabetes medicine tolazamide

Ask your doctor or pharmacist if you are not sure if your medicine is one that is listed above.

Know the medicines you take. Keep a list of your medicines with you to show your doctor and pharmacist each time you get a new medicine.

Oral:

After taking doxepin, you may get up out of bed while not being fully awake and do an activity that you do not know you are doing. The next morning, you may not remember that you did anything during the night. You have a higher chance for doing these activities if you drink alcohol or take other medicines that make you sleepy with doxepin. Reported activities include:

• driving a car ("sleep-driving")
• making and eating food
• talking on the phone
• having sex
• sleep-walking

Call your healthcare provider right away if you find out that you have done any of the above activities after taking doxepin.

1. Take doxepin exactly as prescribed
2. Do not take doxepin:

• with alcohol
• if you take other medicines that can make you sleepy. Talk to your healthcare provider about all of your medicines. Your healthcare provider will tell you if you can take doxepin with your other medicines

Do not take doxepin if you:

• take a monoamine oxidase inhibitor (MAOI) medicine or have taken an MAOI in the last 14 days (2 weeks). Ask your healthcare provider if you are not sure if your medicine is an MAOI.
• have an eye problem called narrow angle glaucoma that is not being treated
• have trouble urinating
• are allergic to any of the ingredients in doxepin.

While taking doxepin, avoid the following:

• You should not drink alcohol while taking doxepin. Alcohol can increase your chances of getting serious side effects with doxepin.
• You should not drive, operate heavy machinery, or do other dangerous activities after doxepin.

What is the most important information I should know about this medication, depression, and other serious mental illnesses, and suicidal thoughts or actions?

1. This medication may increase suicidal thoughts or actions in some children, teenagers, and young adults within the first few months of treatment.
2. Depression and other serious mental illnesses are the most important causes of suicidal thoughts and actions. Some people may have a particularly high risk of having suicidal thoughts or actions. These include people who have (or have a family history of) bipolar illness (also called manic-depressive illness) or suicidal thoughts or actions.
3. How can I watch for and try to prevent suicidal thoughts and actions in myself or a family member?

• Pay close attention to any changes, especially sudden changes, in mood, behaviors, thoughts, or feelings. This is very important when an this medication is started or when the dose is changed.
• Call the healthcare provider right away to report new or sudden changes in mood, behavior, thoughts, or feelings.
• Keep all follow-up visits with the healthcare provider as scheduled. Call the healthcare provider between visits as needed, especially if you have concerns about symptoms.

Topical:

• There is a possibility of sedation. Do not drive a motor vehicle or operate hazardous machinery while being treated with doxepin cream.
• The sedating effects of alcoholic beverages, antihistamines, and other CNS depressants may be increased when doxepin cream is used.
• If excessive drowsiness occurs it may be necessary to reduce the frequency of applications, the amount of cream applied, and/or the amount of cream used, or discontinue the drug.
• Keep away from the eyes.
• Bandages or wraps may increase the absorption of most topical drugs; therefore, these should not be used with doxepin cream.
• Doxepin cream can cause a severe rash to form (a hypersensitivity type reaction).

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.

Before you take doxepin, tell your healthcare provider if you:

• have a history of depression, mental illness, or suicidal thoughts
• have severe sleep apnea
• have kidney or liver problems
• have a history of drug or alcohol abuse or addiction
• have a history of glaucoma or urinary retention
• have any other medical conditions
• are pregnant or plan to become pregnant. It is not known if doxepin will harm your unborn baby. Talk to your healthcare provider if you are pregnant or plan to become pregnant.
• are breastfeeding or plan to breastfeed. Doxepin can pass into your milk and may harm your baby. Talk to your healthcare provider about the best way to feed your baby if you take doxepin. You should not breast-feed while taking doxepin.

Tell your doctor about all of the medicines you take including prescription and nonprescription medicines, vitamins and herbal supplements.

Tell your doctor if you are pregnant or plan to become pregnant.

The FDA categorizes medications based on safety for use during pregnancy. Five categories - A, B, C, D, and X, are used to classify the possible risks to an unborn baby when a medication is taken during pregnancy.

This medication falls into category C. In animal studies, pregnant animals were given this medication and had some babies born with problems. No well-controlled studies have been done in humans. Therefore, this medication may be used if the potential benefits to the mother outweigh the potential risks to the unborn child.

Tell your doctor if you are breastfeeding or plan to breastfeed. Doxepin can pass into your milk and may harm your baby. Talk to your healthcare provider about the best way to feed your baby if you take doxepin. You should not breast-feed while taking doxepin.

Oral:

• Tablets (Silenor) for Insomnia
  • Take within 30 minutes of bedtime.
  • Should not be taken within 3 hours of a meal.
• Capsules and Oral Solution
  • In more severely ill patients higher doses may be required with a gradual increase to 300 mg/day if necessary.
  • If taking once a day, take the dose at bedtime.
  • 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.

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.

If you take too much doxepin, call your healthcare provider or local Poison Control Center, or seek emergency medical attention right away.

• Keep doxepin and all medicines out of the reach of children.
• Store doxepin capsules and doxepin oral solution at 20°-25°C (68°-77°F).
• Store doxepin cream at or below 27° C (80° F).

Doxepin Capsule and Doxepin Oral Solution:

Antidepressants increased the risk compared to placebo of suicidal thinking and behavior (suicidality) in children, adolescents, and young adults in short-term studies of major depressive disorder (MDD) and other psychiatric disorders. Anyone considering the use of doxepin hydrochloride or any other antidepressant in a child, adolescent, or young adult must balance this risk with the clinical need. Short-term studies did not show an increase in the risk of suicidality with antidepressants compared to placebo in adults beyond age 24; there was a reduction in risk with antidepressants compared to placebo in adults aged 65 and older. Depression and certain other psychiatric disorders are themselves associated with increases in the risk of suicide. Patients of all ages who are started on antidepressant therapy should be monitored appropriately and observed closely for clinical worsening, suicidality, or unusual changes in behavior. Families and caregivers should be advised of the need for close observation and communication with the prescriber. Doxepin hydrochloride is not approved for use in pediatric patients.