Zemplar

Zemplar is a calcitriol analog used for the treatment and prevention of hyperparathyroidism in patients with chronic kidney disease who are on dialysis.

Hyperparathyroidism is a condition that is caused when the parathyroid glands overproduce parathyroid hormone which controls the concentrations of calcium and phosphorus in your blood.

This drug helps lower the amount of PTH which lowers the calcium and phosphorus concentrations. This drug requires a prescription.

Before using Zemplar, you must know all about the risks and complications associated with it. Inform your healthcare provider for any allergic reactions to these drugs or any other drugs, foods, dyes, preservatives, or animals. Carefully read the label of non-prescription drugs for any possible allergic reaction or contraindications.

Studies in children 5 years of age and older have not demonstrated any pediatric-specific problems that would limit the utility of paricalcitol injection. Studies in the elderly have not demonstrated any geriatric-specific problems that would limit the utility of paricalcitol injection.

Adverse effects have been reported in animal studies but studies in pregnant women or animals are still inadequate. Infant risk is still undetermined when using this drug during breastfeeding. Discuss with your healthcare professional about the potential risks and benefits of taking this drug while breastfeeding.

Drugs should not be taken together to prevent any interactions but in necessary cases inquire your healthcare provider regarding the adjustments in dosage or any other necessary precautions to prevent any unwanted side effects.

Inform your healthcare professional if you are taking any other drugs such as Ketoconazole. Intake of specific food or using alcohol or tobacco with this drug is associated with an increased risk of certain side effects.

Your healthcare professional can give you special instructions about the use of food, alcohol, or tobacco. Inform your healthcare provider for any other medical problems such as bone disease, heart rhythm problems, hypercalciuria, hyperphosphatemia, hypercalcemia, or Vitamin D overdose.

Proper usage of Zemplar requires strict adherence to your doctor’s orders. You can take this drug with or without food.

The special diet advised to you must be followed. Using antacids or phosphate binders containing aluminum or supplements containing vitamin D, phosphate, or calcium is not recommended.

You may be advised to limit your dietary intake of phosphate. Foods that are high in phosphate include beans, beer, chocolate, cheese, cola soft drinks, ice cream, milk, nuts, peas, whole grain products, and yogurt.

The dose of this drug will be variable for different patients. The directions on the label or the prescription by your healthcare professional should be followed. The dosage of this drug you take depends on the medical problem for which you are using this drug.

Adults with hyperparathyroidism together with chronic kidney disease are given 1 to 2 micrograms once a day or 2 to 4 mcg three times a week as directed by your healthcare professional.

Your healthcare professional may adjust your dose if necessary. Use and dose in children must be determined by your healthcare professional. A missed dose should be taken as soon as possible.

However, skip the missed dose and go back to your regular dosing schedule if it is almost time for your next dose.

Store the drug in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing. Keep out of the reach of children.

Dispose any outdated or expired drugs and ask your healthcare professional for the proper disposal of the drugs.

Before using Zemplar, there are some precautions you must take. Regular visits should be made to your healthcare provider to track your progress and to monitor the effectiveness of the drug. Unwanted effects can be screened using blood and urine tests.

This drug can cause hypercalcemia which can manifest as:

• abdominal or stomach pain
• confusion
• constipation
• depression
• dry mouth
• headache
• incoherent speech
• increased urination
• loss of appetite
• metallic taste
• muscle weakness
• nausea
• thirst
• unusual tiredness
• vomiting
• weight loss

Check with your healthcare professional immediately if you have any of these symptoms.

This drug may increase the aluminum in your blood and may cause harm to your bones if used together with products containing aluminum such as antacids or phosphate binders.

Do not take other drugs unless they have been discussed with your doctor. Your dose may be changed it you are taking another drug, especially digoxin together with paricalcitol.

Make sure you meet with your doctor in using Zemplar to avoid unwanted potential side effects. Side effects may vary for each individual and prompt medical attention should be given if they occur.

Seek advice from your healthcare professional immediately if you experience any unusual symptoms such as:

• black, tarry stools
• bleeding from the rectum or bloody stools
• chest pain or discomfort
• dizziness
• faintness, or lightheadedness when getting up suddenly from a lying or sitting position
• fainting
• fast, slow, irregular, pounding or racing heartbeat or pulse
• swelling of the face, arms, hands, lower legs or feet
• unusual bleeding or bruising
• unusual weight gain
• vomiting of blood or material that looks like coffee grounds
• abdominal or stomach cramps or pain
• chills
• constipation
• cough
• depression
• difficult or labored breathing difficulty with swallowing
• dry mouth or skin
• fever
• inability to speak
• incoherent speech
• increased thirst
• increased urination
• joint pain
• loss of appetite
• metallic taste
• mood or mental changes
• muscle aches and pains
• muscle cramps in the hands, arms, feet, legs or face
• muscle spasms or weakness
• nausea or vomiting
• numbness and tingling in the mouth, fingertips or feet
• pain, redness or swelling at the injection site
• pale skin
• pounding in the ears
• rapid, shallow breathing
• severe or a sudden headache
• shivering
• shortness of breath
• slurred speech
• sweating
• thirst
• tightness in the chest
• tingling of the hands or feet
• tremor
• trouble thinking
• troubled breathing with exertion
• unusual tiredness or weakness
• weakness in the arm or leg on one side of the body
• sudden and severe weight loss
• wheezing
• blurred vision
• confusion
• hoarseness
• large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet or sex organs
• slow or irregular breathing
• trouble sleeping

Some side effects may occur that usually do not need medical attention. As your body adjusts to the medicine, the side effects will slowly disappear. Ask your healthcare professional about ways to prevent or reduce some of these side effects.

If any of the following side effects persists or are inconvenient, or if you notice any other effects, or if you have any questions about them, consult with your health care professional. Report any side effects to the FDA hotline at 1-800-FDA-1088.