diosmiplex, hydrocortisone, and pramoxine

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Pronunciation: dye OS me plex, HYE droe KORT i sone, and pra MOX een

Brand: Analpram Advanced

What is the most important information I should know about diosmiplex, hydrocortisone, and pramoxine ?

You should not use this medication if you are allergic to diosmiplex, hydrocortisone, or pramoxine.

Before using diosmiplex, hydrocortisone, and pramoxine , tell your doctor if you have liver or kidney disease, diabetes, or a history of cancer.

Do not use this medication on a child without a doctor's advice. Children are more sensitive to the effects of topical hydrocortisone.

Do not cover the treated rectal areas with a bandage or other covering unless your doctor has told you to. If you are treating the diaper area of a baby, do not use plastic pants or tight-fitting diapers. Covering the area that is treated with hydrocortisone topical can increase the amount of the drug your skin absorbs, which may lead to unwanted side effects. Follow your doctor's instructions.

Contact your doctor if your condition does not improve or if it gets worse after using this medication.

Do not use diosmiplex, hydrocortisone, and pramoxine to treat any condition that has not been checked by your doctor.

What is diosmiplex, hydrocortisone, and pramoxine ?

Diosmiplex (Vasculera) is a medical food for people with chronic venous insufficiency, a blood circulation disorder. Diosmiplex affects the function of blood vessels in the body.

Pramoxine is an anesthetic. It works by interfering with pain signals sent from the nerves to the brain.

Hydrocortisone is a steroid. It reduces the actions of chemicals in the body that cause inflammation.

Diosmiplex is a oral tablet you take by mouth. Diosmiplex, hydrocortisone, and pramoxine are combined into a cream to be applied to the rectum. The two forms of medicine are supplied in a kit that also contains cleansing wipes.

The diosmiplex, hydrocortisone, and pramoxine kit is used to treat itching, swelling, or irritation caused by hemorrhoids.

Diosmiplex, hydrocortisone, and pramoxine may also be used for purposes not listed in this medication guide.

What should I discuss with my healthcare provider before taking diosmiplex, hydrocortisone, and pramoxine ?

You should not use this medication if you are allergic to diosmiplex, hydrocortisone, or pramoxine.

To make sure you can safely use this medication, tell your doctor if you have any of these other conditions:

  • liver disease;
  • kidney disease; or
  • if you have ever had cancer.

Also tell your doctor if you have diabetes. Steroid medicines may increase the glucose (sugar) levels in your blood or urine. You may also need to adjust the dose of your diabetes medications.

FDA pregnancy category C. It is not known whether diosmiplex, hydrocortisone, and pramoxine will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant while using this medication.

It is not known whether this medication passes into breast milk or if it could harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby.

Do not use this medication on a child without a doctor's advice. Children are more sensitive to the effects of topical hydrocortisone.

How should I use diosmiplex, hydrocortisone, and pramoxine ?

Use exactly as prescribed by your doctor. Do not use in larger or smaller amounts or for longer than recommended. Follow the directions on your prescription label.

Wash your hands before and after applying this medication.

Before you apply the rectal cream, clean the rectal area with a cleansing wipe provided with the Analpram Advanced kit. Follow the directions on the label.

Use only a small amount of medicine when applying the hydrocortisone and pramoxine cream around the outside of the rectum. You may apply the cream 3 to 4 times daily or as directed by your doctor.

Do not cover the treated rectal area with a bandage or other covering unless your doctor has told you to. If you are treating the diaper area of a baby, do not use plastic pants or tight-fitting diapers. Covering the area that is treated with hydrocortisone topical can increase the amount of the drug your skin absorbs, which may lead to unwanted side effects. Follow your doctor's instructions.

Do not use diosmiplex, hydrocortisone, and pramoxine for any condition that has not been checked by a doctor.

Contact your doctor if your condition does not improve or if it gets worse after using this medication.

Store at room temperature away from moisture, heat, and light.

What happens if I miss a dose?

Use the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not use extra medicine to make up the missed dose.

What happens if I overdose?

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

An overdose of hydrocortisone applied to the rectum is not expected to produce life-threatening symptoms. However, long-term use of high steroid doses can lead to symptoms such as thinning skin, easy bruising, changes in the shape or location of body fat (especially in your face, neck, back, and waist), increased acne or facial hair, menstrual problems, impotence, or loss of interest in sex.

What should I avoid while taking diosmiplex, hydrocortisone, and pramoxine ?

Avoid getting this medication in your eyes.

Avoid applying other rectal medications on the same treatment area with diosmiplex, hydrocortisone, and pramoxine , unless your doctor has told you to.

What are the possible side effects of diosmiplex, hydrocortisone, and pramoxine ?

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

Stop using this medication and call your doctor at once if you have a serious side effect such as:

  • severe burning, itching or irritation of the treated area; or
  • rectal bleeding.

Less serious side effects may include:

  • mild burning, itching, or dryness of the treated area.
  • headache;
  • mild skin rash;
  • leg cramps;
  • upset stomach; or
  • swelling in your hands or feet.

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.

What other drugs will affect diosmiplex, hydrocortisone, and pramoxine ?

There may be other drugs that can interact with diosmiplex, hydrocortisone, and pramoxine. Tell your doctor about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal products. Do not start a new medication without telling your doctor.

Where can I get more information?

Your pharmacist can provide more information about diosmiplex, hydrocortisone, and pramoxine .

Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.

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