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|Raudixin

RAUWOLFIA ALKALOIDS (Systemic)

Some commonly used brand names are:

In the U.S.—

• Harmonyl ¹
• Raudixin ²
• Rauval ²
• Rauverid ²
• Serpalan ³
• Wolfina ²

In Canada—

• Novoreserpine ³
• Reserfia ³
• Serpasil ³

Category

• Antihypertensive—Deserpidine; Rauwolfia Serpentina; Reserpine
• Vasospastic therapy adjunct—Deserpidine; Rauwolfia Serpentina; Reserpine

Description

Rauwolfia alkaloids belong to the general class of medicines called antihypertensives. They are used to treat high blood pressure (hypertension).

High blood pressure adds to the workload of the heart and arteries. If it continues for a long time, the heart and arteries may not function properly. This can damage the blood vessels of the brain, heart, and kidneys, resulting in a stroke, heart failure, or kidney failure. High blood pressure may also increase the risk of heart attacks. These problems may be less likely to occur if blood pressure is controlled.

Rauwolfia alkaloids work by controlling nerve impulses along certain nerve pathways. As a result, they act on the heart and blood vessels to lower blood pressure.

Rauwolfia alkaloids may also be used to treat other conditions as determined by your doctor.

These medicines are available only with your doctor"s prescription, in the following dosage forms:

• Oral
• Deserpidine
  • Tablets (U.S.)
• Rauwolfia Serpentina
  • Tablets (U.S.)
• Reserpine
  • Tablets (U.S. and Canada)

Before Using This Medicine

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For rauwolfia alkaloids, the following should be considered:

Allergies—Tell your doctor if you have ever had any unusual or allergic reaction to rauwolfia alkaloids. Also tell your health care professional if you are allergic to any other substance, such as foods, preservatives, or dyes.

Pregnancy—Rauwolfia alkaloids have not been studied in pregnant women. However, too much use of rauwolfia alkaloids during pregnancy may cause unwanted effects (difficult breathing, low temperature, loss of appetite) in the baby. In rats, use of rauwolfia alkaloids during pregnancy causes birth defects and in guinea pigs decreases newborn survival rates. Before taking this medicine, make sure your doctor knows if you are pregnant or if you may become pregnant.

Breast-feeding—Rauwolfia alkaloids pass into breast milk and may cause unwanted effects (difficult breathing, low temperature, loss of appetite) in infants of mothers taking large doses of this medicine. Be sure you have discussed this with your doctor before taking this medicine.

Children—Although there is no specific information comparing use of rauwolfia alkaloids in children with use in other age groups, rauwolfia alkaloids are not expected to cause different side effects or problems in children than they do in adults.

Older adults—Many medicines have not been studied specifically in older people. Therefore, it may not be known whether they work exactly the same way they do in younger adults. Although there is no specific information comparing use of rauwolfia alkaloids in the elderly with use in other age groups, dizziness or drowsiness may be more likely to occur in the elderly, who are more sensitive to the effects of rauwolfia alkaloids.

Other medicines—Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking rauwolfia alkaloids, it is especially important that your health care professional know if you are taking any of the following:

• Monoamine oxidase (MAO) inhibitor activity (isocarboxazid [e.g., Marplan], phenelzine [e.g., Nardil], procarbazine [e.g., Matulane], selegiline [e.g., Eldepryl], tranylcypromine [e.g., Parnate])—Taking a rauwolfia alkaloid while you are taking or within 2 weeks of taking MAO inhibitors may increase the risk of central nervous system depression or may cause a severe high blood pressure reaction

Other medical problems—The presence of other medical problems may affect the use of rauwolfia alkaloids. Make sure you tell your doctor if you have any other medical problems, especially:

• Allergies or other breathing problems such as asthma—Rauwolfia alkaloids can cause breathing problems

• Epilepsy

• Gallstones or
• Stomach ulcer or
• Ulcerative colitis—Rauwolfia alkaloids increase activity of the stomach, which may make the condition worse

• Heart disease—Rauwolfia alkaloids can cause heart rhythm problems or slow heartbeat

• Kidney disease—Some patients may not do well when blood pressure is lowered by rauwolfia alkaloids

• Mental depression (or history of)—Rauwolfia alkaloids cause mental depression

• Parkinson"s disease—Rauwolfia alkaloids can cause parkinsonism-like effects

• Pheochromocytoma

Proper Use of This Medicine

For patients taking this medicine for high blood pressure :

• In addition to the use of the medicine your doctor has prescribed, treatment for your high blood pressure may include weight control and care in the types of foods you eat, especially foods high in sodium. Your doctor will tell you which of these are most important for you. You should check with your doctor before changing your diet.
• Many patients who have high blood pressure will not notice any signs of the problem. In fact, many may feel normal. It is very important that you take your medicine exactly as directed and that you keep your appointments with your doctor even if you feel well.
• Remember that this medicine will not cure your high blood pressure but it does help control it. Therefore, you must continue to take it as directed if you expect to lower your blood pressure and keep it down. You may have to take high blood pressure medicine for the rest of your life . If high blood pressure is not treated, it can cause serious problems such as heart failure, blood vessel disease, stroke, or kidney disease.

To help you remember to take your medicine, try to get into the habit of taking it at the same time each day.

This medicine is sometimes given together with certain other medicines. If you are using a combination of drugs, make sure that you take each medicine at the proper time and do not mix them. Ask your health care professional to help you plan a way to remember to take your medicines at the right times.

If this medicine upsets your stomach, it may be taken with meals or milk. If stomach upset (nausea, vomiting, stomach cramps or pain) continues or gets worse, check with your doctor.

Dosing—The dose of these medicines will be different for different patients. Follow your doctor"s orders or the directions on the label . The following information includes only the average doses of these medicines. If your dose is different, do not change it unless your doctor tells you to do so.

The number of tablets that you take depends on the strength of the medicine.

• For deserpidine
• For oral dosage form (tablets):
  • For high blood pressure:
    • Adults—250 to 500 micrograms (mcg) a day. This may be taken as a single dose or divided into two doses.
    • Children—Dose must be determined by your doctor.

• For rauwolfia serpentina
• For oral dosage form (tablets):
  • For high blood pressure:
    • Adults—50 to 200 milligrams (mg) a day. This may be taken as a single dose or divided into two doses.
    • Children—Dose must be determined by your doctor.

• For reserpine
• For oral dosage form (tablets):
  • For high blood pressure:
    • Adults—100 to 250 micrograms (mcg) a day.
    • Children—Dose is based on body weight and must be determined by your doctor. The usual dose is 5 to 20 mcg per kilogram (kg) (2.27 to 9.1 mcg per pound) of body weight a day. This may be taken as a single dose or divided into two doses.

Missed dose—If you miss a dose of this medicine, do not take the missed dose at all and do not double the next one. Instead, go back to your regular dosing schedule.

Storage—To store this medicine:

• Keep out of the reach of children.
• Store away from heat and direct light.
• Do not store in the bathroom, near the kitchen sink, or in other damp places. Heat or moisture may cause the medicine to break down.
• Do not keep outdated medicine or medicine no longer needed. Be sure that any discarded medicine is out of the reach of children.

Precautions While Using This Medicine

It is important that your doctor check your progress at regular visits to make sure that this medicine is working properly.

For patients taking this medicine for high blood pressure :

• Do not take other medicines unless they have been discussed with your doctor . This especially includes over-the-counter (nonprescription) medicines for appetite control, asthma, colds, cough, hay fever, or sinus problems, since they may tend to increase your blood pressure.

Before having any kind of surgery (including dental surgery) or emergency treatment, tell the medical doctor or dentist in charge that you are taking this medicine .

In some patients, this medicine may cause mental depression. Tell your doctor right away :

• if you or anyone else notices unusual changes in your mood.
• if you start having early-morning sleeplessness or unusually vivid dreams or nightmares.

This medicine will add to the effects of alcohol and other CNS depressants (medicines that slow down the nervous system, possibly causing drowsiness). Some examples of CNS depressants are antihistamines or medicine for hay fever, other allergies, or colds; sedatives, tranquilizers, or sleeping medicine; prescription pain medicine or narcotics; barbiturates; medicine for seizures; muscle relaxants; or anesthetics, including some dental anesthetics. Check with your doctor before taking any of the above while you are using this medicine .

This medicine may cause some people to become drowsy or less alert than they are normally. This is more likely to happen when you begin to take it or when you increase the amount of medicine you are taking. Make sure you know how you react to this medicine before you drive, use machines, or do anything else that could be dangerous if you are not alert .

This medicine may cause dryness of the mouth. For temporary relief, use sugarless candy or gum, melt bits of ice in your mouth, or use a saliva substitute. However, if dry mouth continues for more than 2 weeks, check with your medical doctor or dentist. Continuing dryness of the mouth may increase the chance of dental disease, including tooth decay, gum disease, and fungus infections.

This medicine often causes stuffiness in the nose. However, do not use nasal decongestant medicines without first checking with your health care professional.

Side Effects of This Medicine

Suggestions that rauwolfia alkaloids may increase the risk of breast cancer occurring later have not been proven. However, rats and mice given 100 to 300 times the human dose had an increased number of tumors.

Other side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. However, check with your doctor if any of the following side effects continue or are bothersome:

After you stop using this medicine, it may still produce some side effects that need attention. During this period of time check with your doctor immediately if you notice any of the following side effects:

Drowsiness or faintness; impotence or decreased sexual interest; irregular or slow heartbeat; lack of energy or weakness; mental depression or inability to concentrate; nervousness or anxiety; vivid dreams or nightmares or early-morning sleeplessness

Other side effects not listed above may also occur in some patients. If you notice any other effects, check with your doctor.

Additional Information

Once a medicine has been approved for marketing for a certain use, experience may show that it is also useful for other medical problems. Although this use is not included in product labeling, reserpine is used in certain patients with the following medical condition:

• Raynaud"s disease

Other than the above information, there is no additional information relating to proper use, precautions, or side effects for this use.

Revised: 08/19/1998

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