| you first receive medication to treat ADHD and each time you get a refill, in case there are any changes to the Guide. The Guide is in a user-friendly format; the information covered is described below.12
Parts of the Medication Guide
What is the most important information I should know about
[this drug]?
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| This section contains: |
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Important side effects that have been reported with the use of the drug |
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Medical conditions your child may have that the doctor should know about before your child uses the drug |
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Side effects that should be reported promptly to your child’s physician should they occupy |
What is [this drug]?
This section explains how the medication acts and describes its use in ADHD.
Controlled substance warning
There will be a Boxed Warning if the drug is a controlled substance, meaning the drug can be abused or lead to dependence.
Who should not take [this drug]?
This section lists other health issues that would be reasons why your child should not take this drug. It also lists medical conditions in your child or your family that you should tell your doctor about.
Can [this drug] be taken with other medicines?
This section explains that you should tell your child’s physician about all the medications he or she takes, including prescription and nonprescription drugs, vitamins and herbal preparations.
How should [this drug] be taken?
This section describes how and when to take the medication.
What are possible side effects of [this drug]?
Serious and common side effects are listed here.
How should I store [this drug]?
This section explains how to properly store the drug.
General information about [this drug].
This section discusses information about the drug and how to obtain further information.
What are the ingredients in [this drug]?
This section lists the active and inactive ingredients as well as the manufacturer, distributor and marketer.
In addition to the Medication Guide, you may receive other printed information about the medication from the pharmacist. This information is known as the Prescribing Information (PI), and is usually available on the product’s Web site.
The PI is prepared by the drug company and approved by the Food and Drug Administration (FDA). While the PI may contain information geared to you and your child, it provides comprehensive and pertinent information for the doctor to ensure the medication is being used safely and appropriately. The style of PIs vary from company to company, but the FDA requires PIs to contain specific information, including the drug’s approved uses, potential side effects, and contraindications (a symptom, product, or condition that makes a particular treatment or procedure inadvisable).13
Given the complicated terminology, you can tell that PIs were never intended for general consumers; they are written for medical professionals. They can be very useful though, so the following section of the Kit will help you translate the information into terms you can more easily understand and discuss with your child’s doctor. Typically, simpler versions of PIs, known as patient information, are provided by the pharmacist or available on the product’s Web site. Below is a description of the terms and information you will find in a PI. This information may be helpful, but should not be a substitute for talking with your doctor or pharmacist about the medicine your child is about to take.
Parts of the Prescribing Information
| Description
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The generic (chemical) name (i.e., methylphenidate) and brand name of the medication |
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Dosage form (i.e., capsules, tablets, liquid, etc.), the way it is administered (i.e., taken by mouth, injected, etc.), and available strengths (i.e., 5 mg) |
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Pharmacological or therapeutic class (i.e., central nervous system stimulant) |
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Chemical name, structural formula, and active and inactive ingredients |
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Any other appropriate information, such as how the medication is delivered and absorbed into the body |
Clinical Pharmacology
This section refers to the properties and actions of the medication or how it works in the body.
Indication and Usage
This section states which medical conditions the medication can treat, as approved by the FDA based on clinical studies.
Contraindications
This section outlines a summary of the situations or conditions in which the drug should not be used because the risk clearly outweighs any possible therapeutic benefit.14
Warnings and Precautions15
All medicines – both prescription and over the counter – have risks as well as benefits. This section outlines the possible serious side effects (also known as adverse events) the medication may cause, and provides important information for the doctor in deciding if the medication is right for your child.
In some cases, the FDA can require a drug manufacturer to place a “black box” in the PI to call the doctor’s attention to a side effect that requires special attention or has been observed to be life threatening.
Adverse Reactions16
It’s important to remember that every person responds to medications differently. Adverse events can range from mild to severe. This section includes a listing of adverse reactions that have been observed in studies or frequently reported, and that may have caused serious outcomes or prompted patients to stop taking the medication.
Medication Abuse and Dependence17
This section discusses whether or not the medication is considered to have potential for abuse, dependence or withdrawal issues.
Overdose18
This section describes the signs, symptoms and associated complications that can occur if your child takes more medication than was prescribed.
Dosing and Administration19
This section provides instructions on how to give the medication to your child. It offers guidelines as to the usual dosage range, timing between doses, the length of treatment and any modification of dosage needed for specific patients – such as children or people with particular diseases.
Because everyone has a unique response to medication, a physician may need to adjust your child’s dose over time to determine what’s optimal. This adjustment is called "titration." Titration is used with many medications, from blood pressure control to cholesterol management. When your doctor first prescribes your child’s ADHD medicine, he or she will prescribe a starting dose. If needed, your child's doctor may periodically increase or decrease this dose until symptoms are effectively under control. This dosing “titration” may happen in the beginning of your child's medication therapy, or sometime later, as his or her needs change.
How Supplied20
This area describes characteristics of the medicine. For example, whether it is available in liquid or tablet form, the shape and color of the medication to help identification, special handling and storage conditions, and how the medication is packaged for the pharmacy, such as in bottles of 100.
Additional Sections
The package insert may also contain these additional section headings, if appropriate, and in compliance with federal regulations:
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Animal pharmacology.21 During the life cycle of any medicine being tested and put on the market, the FDA requires testing the safety of the medication in animals. If they find significant adverse effects in animals, those will be noted here. It’s important to note that humans do not always have the same reactions as animals, but this information is sometimes included in the package insert for your doctor’s information.
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Clinical studies or references.22 As mentioned above, before a medication can be put on the market, the FDA requires testing of its safety and effectiveness in humans. This section shows the results of testing this medication among humans. |
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