Parlodel

Generic name: bromocriptine

What is Parlodel used for?

Parlodel is used to treat acromegaly. It is used to treat high prolactin levels. Parlodel is also used to treat Parkinson’s disease.

It is used to treat some prolactin-secreting tumors.

Parlodel may be given to you for other reasons. Talk to your doctor.

Description

Parlodel(bromocriptine mesylate) is an ergot derivative with potent dopamine receptor agonist activity. Each Parlodel(bromocriptine mesylate) SnapTabs® tablet for oral administration contains 2½ mg and each capsule contains 5 mg bromocriptine (as the mesylate). Bromocriptine mesylate is chemically designated as Ergotaman-3′, 6′, 18-trione, 2-bromo-12′- hydroxy-2′- (1-methylethyl) -5′-(2-methylpropyl) -, (5′α) -monomethanesulfonate (salt).

 

The structural formula for Parlodel® (bromocriptine mesylate) is an ergot derivative with potent dopamine receptor agonist activity. Each Parlodel® (bromocriptine mesylate) SnapTabs® tablet for oral administration contains 2½ mg and each capsule contains 5 mg bromocriptine (as the mesylate). Bromocriptine mesylate is chemically designated as Ergotaman 3′, 6′, 18 trione, 2-bromo-12′- hydroxy 2′ (1 methylethyl) 5′ (2 methylpropyl) , (5′α) monomethanesulfonate (salt).

2½ mg SnapTabs

Active Ingredient: bromocriptine mesylate, USP

Inactive Ingredients: colloidal silicon dioxide, lactose, magnesium stearate, maleic acid, povidone, starch, and another ingredient

5 mg Capsules

Active Ingredient: bromocriptine mesylate, USP

Inactive Ingredients: colloidal silicon dioxide, gelatin, lactose, magnesium stearate, red iron oxide, silicon dioxide, sodium lauryl sulfate, starch, maleic acid, titanium dioxide, yellow iron oxide, and another ingredient

Before taking Parlodel, tell your doctor:

  • If you are allergic to Parlodel; any part of this medicine; or any other drugs, foods, or substances. Tell your doctor about the allergy and what signs you had.
  • If you have high blood pressure.
  • If you have a rare hereditary problem of galactose intolerance, Lapp lactase deficiency, or glucose-galactose malabsorption.
  • If you take any drugs (prescription or OTC, natural products, vitamins) that must not be taken with Parlodel, like certain drugs that are used for mental or mood problems, migraines, or stomach or bowel problems. There are many drugs that must not be taken with Parlodel.
  • If you are pregnant or plan to get pregnant.
  • If you have just had a baby.
  • If you are breast-feeding. Do not breast-feed while you take Parlodel.

This is not a list of all drugs or health problems that interact with this medicine.

Tell your doctor and pharmacist about all of your drugs (prescription or OTC, natural products, vitamins) and health problems. You must check to make sure that it is safe for you to take Parlodel with all of your drugs and health problems. Do not start, stop, or change the dose of any drug without checking with your doctor.

What are some things I need to know or do while I take Parlodel?

  • Tell all of your health care providers that you take Parlodel. This includes your doctors, nurses, pharmacists, and dentists.
  • Avoid driving and doing other tasks or actions that call for you to be alert until you see how Parlodel affects you.
  • If you have ever felt sleepy or have fallen asleep all of a sudden when taking Parlodel, avoid doing tasks or actions that may not be safe for you or others if you pass out. These are driving, climbing, and swimming.
  • To lower the chance of feeling dizzy or passing out, rise slowly if you have been sitting or lying down. Be careful going up and down stairs.
  • Talk with your doctor before you drink alcohol.
  • Check your blood pressure as you have been told.
  • Have blood work checked as you have been told by the doctor. Talk with the doctor.
  • If you have been taking Parlodel for many weeks, talk with your doctor before stopping. You may want to slowly stop Parlodel.
  • Some people who took Parlodel to treat acromegaly had bleeding from the stomach or bowel ulcers. Sometimes this has been deadly. If you have questions, talk with the doctor.
  • If you are trying to avoid pregnancy, use a non-hormone kind of birth control like a condom when taking Parlodel. You may need to also have pregnancy tests while taking Parlodel.

Parkinson’s disease:

  • The chance of a type of skin cancer called melanoma may be raised in people with Parkinson’s disease. It is not known if Parlodel may also raise the chance. Have skin exams while you take Parlodel. Talk with your doctor.

How is Parlodel best taken?

Use Parlodel as ordered by your doctor. Read all information given to you. Follow all instructions closely.

  • Take with food to prevent an upset stomach.
  • Keep taking Parlodel as you have been told by your doctor or other health care provider, even if you feel well.

What do I do if I miss a dose?

  • Take a missed dose as soon as you think about it.
  • If it is close to the time for your next dose, skip the missed dose and go back to your normal time.
  • Do not take 2 doses at the same time or extra doses.

What are the side effects of Parlodel that I need to call my doctor about immediately?

WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:

For all uses of Parlodel:

  • Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing, swallowing, or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
  • Signs of high or low blood pressure like very bad headache or dizziness, passing out, or change in eyesight.
  • Mental, mood, or behavior changes that are new or worse.
  • Weakness on 1 side of the body, trouble speaking or thinking, change in balance, drooping on one side of the face, or blurred eyesight.
  • Chest pain or pressure.
  • Shortness of breath, a big weight gain, or swelling in the arms or legs.
  • Falling asleep during activities such as eating or talking.
  • Back pain.
  • Not able to pass urine or change in how much urine is passed.
  • Seizures.
  • Black, tarry, or bloody stools.
  • Throwing up blood or throw up that looks like coffee grounds.
  • Very bad belly pain.
  • Hallucinations (seeing or hearing things that are not there).
  • Feeling confused.
  • Strong urges that are hard to control (such as eating, gambling, sex, or spending money).

Parkinson’s disease:

  • Trouble controlling body movements that is new or worse.

What are some other side effects of Parlodel?

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:

  • Headache.
  • Upset stomach or throwing up.
  • Constipation.
  • Feeling dizzy, sleepy, tired, or weak.
  • Trouble sleeping.

These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.

You may report side effects to the FDA at 1-800-332-1088. You may also report side effects at https://www.fda.gov/medwatch.

If overdose is suspected:

If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

Label

  • NDC 30698-202-30
    Parlodel®
    (bromocriptine mesylate) tablets, USP
    2 ½ mg 30 Snap Tabs®
    Rx Only

    PRINCIPAL DISPLAY PANEL NDC 30698-202-30 Parlodel® (bromocriptine mesylate) tablets, USP 2 ½ mg 30 Snap Tabs® Rx Only

    Imprint PARLODEL 2 1/2 - Parlodel 2.5 mg

  • NDC 30698-202-01
    Parlodel®
    (bromocriptine mesylate) tablets, USP
    2 ½ mg 100 Snap Tabs®
    Rx Only

    PRINCIPAL DISPLAY PANEL NDC 30698-202-01 Parlodel® (bromocriptine mesylate) tablets, USP 2 ½ mg 100 Snap Tabs® Rx Only

  • NDC 30698-201-30
    Parlodel®
    (bromocriptine mesylate) capsules, USP
    5 mg 30 Capsules
    Rx Only

    PRINCIPAL DISPLAY PANEL NDC 30698-201-30 Parlodel® (bromocriptine mesylate) capsules, USP 5 mg 30 Capsules Rx Only

     Parlodel 2

  • NDC 30698-201-01
    Parlodel®
    (bromocriptine mesylate) capsules, USP
    5 mg 100 Capsules
    Rx Only

    PRINCIPAL DISPLAY PANEL NDC 30698-201-01 Parlodel® (bromocriptine mesylate) capsules, USP 5 mg 100 Capsules Rx Only

 

How supplied/storage

Parlodel (bromocriptine mesylate) SnapTabs

2½ mg

Parlodel is available in bottle containing 30 and 100 tablets of 2 ½ mg, each bottle contains a desiccant.

Round, off-white, bevelled-edge SnapTabs, each containing 2½ mg bromocriptine (as the mesylate). Engraved “PARLODEL 2½” on one side and “017” on the scored side. Complies with USP dissolution test 1.

Packages of 30………………………………………………..NDC 30698-202-30

Packages of 100………………………………………………NDC 30698-202-01

Parlodel (bromocriptine mesylate) Capsules

5 mg

Caramel and white capsules, each containing 5 mg bromocriptine (as the mesylate). Imprinted in red ink “PARLODEL 5 mg” on one half and “102” on other half.

Packages of 30………………………………………………..NDC 30698-201-30

Packages of 100………………………………………………NDC 30698-201-01

Store and Dispense

Store at 68º to 77ºF (20º to 25ºC); excursions permitted to 59º to 86ºF (15º to 30ºC) [See USP Controlled Room Temperature].

Dispense in a tight, light-resistant container.

 

Manufactured for and Distributed by:
Validus Pharmaceuticals LLC
Parsippany, NJ 07054
[email protected]
www.validuspharma.com
1-866-982-5438

SRC: NLM .

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