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Zemplar

Generic Name: Paricalcitol (oral or injection) [Par-i-KAL-si-tol]
Drug Class: Vitamins

What is Zemplar?

Zemplar is a synthetic (man-made) version that contains vitamin D. Vitamin D is essential for the absorption of calcium in the stomach and the function of calcium in the body.Zemplar is used to treat or prevent overactive parathyroid glands (hyperparathyroidism) in people with chronic kidney disease who are on dialysis.

Zemplar oral capsules are designed for use by adults and children who are at least 10 years old. The injection can be used for children and adults who are at least 5 years old.

Warnings

You shouldn't use Zemplar when you have a high level of vitamin D or calcium in your blood.Before you take Zemplar, inform your physician if you suffer from elevated blood pressure or liver conditions as well as an imbalance in electrolytes.Do not take any other mineral or vitamin supplements unless your physician has instructed you to.

Avoid taking a calcium supplement or an antacid unless on the advice of your physician. Only use the type of antacid or supplement recommended by your doctor. Inform your doctor of all of your prescription and over-the-counter supplements, including minerals, vitamins, and herbal supplements, as well as medicines prescribed by other doctors. Don't start any new medication without first talking to your doctor.

When you take this medication, You may require blood tests in the doctor's office. Visit your doctor regularly.Get medical attention immediately. If you believe you've taken too much of this drug, A high dose of vitamin D may cause life-threatening or serious adverse effects.

The signs of a drug overdose could include weakness, headaches, or drowsiness. Dry mouth, nausea, vomiting, constipation, bone or muscle discomfort, a metallic taste in the mouth, weight loss, as well as itchy skin Changes of heartbeat, lack of interest in sexual activity or sexual activity, confusion, odd behavior or thoughts, sensations of extreme heat, intense stomach pain that extends to your back, or even fainting

Similar or related drugs

cinacalcet, Sensipar, paricalcitol, doxercalciferol, and hectorol

Before you take this drug

You shouldn't take Zemplar if you have an allergy to paricalcitol or have excessive levels of calcium or vitamin D in your body.It is not recommended to treat with Zemplar injection if you have suffered an extremely allergic reaction before.

To be sure Zemplar is appropriate for you, consult your doctor if:

  • Hypertension;
  • Liver disease
  • An electrolyte imbalance (such as a low level of magnesium or potassium within your blood).

See your doctor if you are pregnant or nursing.

If you are breastfeeding while receiving Zemplar injections, watch for signs of hypercalcemia in your child (such as feeding issues, vomiting, constipation, or seizures).

How to take Zemplar?

You should take Zemplar exactly as directed by your physician. Follow the directions on the prescription label and go through all medication guides and instruction sheets. Your doctor may alter your dosage.Zemplar is typically given every two days or three times a week. Follow the instructions of your physician with care.Zemplar capsules can be taken by mouth.You can take oral capsules either with or without meals.

Zemplar injection is administered as an injection into a vein during dialysis. Your healthcare provider will offer the injection.Inform your doctor if you experience discomfort, burning, or swelling while getting the injection.Your blood needs to be checked frequently. The doses you receive could be delayed depending on the results.

Even if there are no symptoms, tests can assist your doctor in determining the effectiveness of this medication.There is a possibility that you need to adhere to an individualized diet when using Zemplar. Follow all the instructions given by your physician or dietitian. Find out about the foods you should be aware of or avoid to keep your health in check.Keep Zemplar capsules for oral use within the room at room temperature, away from light, moisture, and temperatures.

Details on dosage

Usual Adult Dose for Secondary Hyperparathyroidism:

Injectable:
Dose initial: 0.04 to 0.1 mcg/kg (2.8 to 7 mg) is injected as a bolus dose via an access port for hemodialysis at any point during dialysis.
Maximum frequency each day
Comments:
Do not inject directly into a vein.
Treatment and prevention of secondary hyperparathyroidism resulting from chronic kidney disease stage 5
Oral:
Initial dose:
Stage 3 or 4 chronic kidney disease (CKD):
Dosing for the initial dosage is based on the baseline level of intact parathyroid hormone (iPTH):
500 pg/mL or less, 1 mg orally every day, or 2 mcg orally three times a week.
If you are over 500 mg/mL, take 2 mg orally every day or 4 mg orally three times per week.
Stage 5 CKD:
Starting dose (micrograms) = baseline iPTH level (pg/mL)/80
The dose to start is administered three times per week, orally, and only begins if your baseline serum calcium level has been adjusted to 9.5 mg/dL or less.
Comments:
If you are giving three times a week, don't give more frequently than you do every other day.
Treatment and prevention of secondary hyperparathyroidism that is associated with
Chronic Kidney Disease (CKD) stages 3 and 4 (oral item only) or
5-CKD stage 5 with hemodialysis or dialysis peritoneal (oral or injectable)

Normal Paediatric Dose for Secondary Hyperparathyroidism:

The safety and efficacy of the drug have not been proven in children.
The following are the dosages that were used in a small study for children:
The data is not available for children who are younger than five years old.
The first dose, for children between 5 and 18 years old:
0.04 mg/kg three times a week if you have a baseline of intact parathyroid hormone (iPTH) lower than 500 pg/mL.
0.08 mg/kg three times per week if the baseline iPTH is greater than 500 pg/mL.
Injected as a bolus dosage through a hemodialysis port at any point during dialysis.
Maximum frequency each day
Comments:
Don't inject directly into a vein.
Treatment and prevention of secondary hyperparathyroidism resulting from chronic kidney disease stage 5

What happens If I miss a dose?

Do not take the medicine for as long as you can. However, do not take any missed doses if you are close to the time of the next dose. Don't take two doses at a time.

Since you'll be receiving Zemplar injections in a medical setting, you're not likely to be able to miss an injection. Contact your physician for directions when you don't make an appointment for hemodialysis.

What happens if I overdose?

For medical emergencies, seek emergency medical attention or contact the Poison Help line toll-free at 1-800-222-1222.

What should be avoided?

Do not take vitamin D, calcium, or supplementation without the advice of your physician.

If you are taking Zemplar oral, consult your physician prior to using an antacid. Make sure you use only the kind that your doctor recommends.

Grapefruit can interact with paricalcitol, causing undesirable adverse effects. Do not use products containing grapefruit.

Side effects of Zemplar

See a doctor immediately. If you show symptoms that you are experiencing an allergic reaction with Zemplar, such as itching or breathing difficulties and swelling of your lips, tongue, throat, or face,

See your doctor right away. If you are suffering from:

  • Speedy, slow, or heartbeats that pound;
  • Symptoms of flu, fever, throat, and mouth ulcers;
  • New or worsening cough trouble breathing, fever
  • A seizure;
  • High levels of calcium high calcium levels nausea, vomiting, loss of appetite, constipation, more thirst or urination, weight loss, and fatigue.

There is a higher chance of suffering a fractured bone in the event that your parathyroid hormone levels drop to a low level. Discuss with your physician ways to reduce the chance of breaking bones.

Common zemplar side effects can be:

  • Nausea, vomiting;
  • Swelling of your feet or hands
  • Spinning sensation and spinning
  • Joint pain,
  • Runny nose.

This isn't a complete list of all the side effects. Other side effects could occur. Contact your doctor for advice regarding medical effects. You can report any adverse reactions to the FDA at 1-800-FDA-1088.

Interaction with other drugs

Certain medicines may cause paricalcitol to be less effective if taken together. If you are taking any of these medicines, then you should take your daily Zemplar dose at least 1 hour prior to or up to 4 hours after taking the other medication.

  • Cholestyramine;
  • Mineral oil.

Talk to your physician about all your medications that you are taking. Certain medications may interfere with paricalcitol, including:

  • Digoxin (digitalis);
  • Diuretic, also known as a "water pill";
  • Nefazodone;
  • A binder made of phosphate ferric citrate sevelamer, lanthanum carbonate;
  • Is an antibiotic one can use to treat clarithromycin and telithromycin.
  • Antifungal medicine: itraconazole, ketoconazole,
  • Antiviral medicine used to treat HIV/AIDS Indinavir, nelfinavir, ritonavir, and saquinavir

This list isn't complete, and a variety of other medications could interfere with paricalcitol. This includes prescription and over-the-counter drugs, vitamins, and herbal products. The interactions of all drugs are listed here.

DRUG STATUS

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Prescription only

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