Low-Dose Naltrexone

Benefits:

• Possible uses include treatment of fibromyalgia, auto-immune diseases (i.e., Crohn's disease, rheumatoid arthritis, ulcerative colitis, etc.), multiple sclerosis, cancer, autism, depression, pain management and improvement in immune system function.
• Doctors may prescribe medications for off-label use, meaning the FDA has not approved the medication to treat that specific condition. Ask your pharmacist or physician if you have any questions regarding the use of your medication.
• The amount of time it takes to see the full effects of the medication varies between each patient. Consult your prescriber for additional information.

Side Effects

• Possible side effects include nausea, abdominal cramps or pain, or difficulty sleeping.
• Severe side effects are rare but may occur. Severe side effects include liver damage, with signs of yellowing skin or eyes, dark urine, abdominal pain, and fever.
• If you experience a severe adverse event, please call your physician immediately and you may also report your experience to the FDA Med-Watch Program at 1-800-FDA-1088.

Administration

• Always follow the directions on your prescription label on how to take your medication.
• Oral Forms:

1. Capsule: swallow whole. Do not crush or chew.
2. Tablet: follow the directions on your prescription
3. Oral liquid: swallow prescribed amount using measuring tool provided
4. Sublingual tablet: place under the tongue and let tablet dissolve
5. Topical: clean and dry the designated area, then apply the recommended amount of medication to the area and rub in well for 2 minutes. After administration, wash hand thoroughly to prevent transferring medication onto others.

Duty to Warn for Topical Medications

It is possible for topical medications to be transferred on to other individuals through casual contact which can lead to unwanted side effects in those individuals. To prevent their exposure, don’t allow skin-to-skin to contact of the treated area with other adults, children or pets. Keep the treated area covered with loose fitting clothing or lightly wrapped gauze until the drug is completely absorbed, which can take up to 4 hours.

Hand washing does not remove all the drug residue from your skin. It is best to apply medication with a disposable glove. Ask your pharmacist about any questions or concerns you might have.

Additional Information/Warnings

• Do not take this medication with opioid drugs.
• If you miss a dose of this medication, take it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once and if you have any questions, please contact your physician or pharmacist.
• Before taking this medication, tell your healthcare provider about all the medicines, herbal supplements, vitamins, and over the counter medications that you are currently taking.
• Call your doctor immediately if you are pregnant, intend to become pregnant, or intend to breastfeed. Your doctor will need to review each medication used during pregnancy or breastfeeding.
• Continue to have routine follow-up within order to assess and monitor your medication for your disease state as recommended by your healthcare provider.
• Do not share medication with another person, even if they have the same symptoms you are experiencing.
• The information in this patient advisory leaflet is not intended to cover all possible uses, directions, precautions, drug interactions, or adverse effects. If you have questions about the medicines, you are taking or would like more information, check with your doctor or pharmacist.
• This compound medication is customized for the patient and is exclusively available with the prescription from a prescriber.
• Please refer to receipt for a list of ingredients in your medication.

Storage

• Refer to the label on your prescription for refrigeration requirements (do not freeze).
• If refrigeration is NOT required- store medication at room temperature in a cool, dry place. Do not store it in the bathroom, a vehicle, or any other location with varying temperatures or humidity.
• If refrigeration is required, store in the refrigerator out of reach of children.
• Compounded medications are not usually prepared in child resistant containers and should be kept away from children and pets. If you would like to have a lockable zip lock bag for your compounded medications, please call the pharmacy and ask the technician to include child resistant packaging with your refills.
• Unused medications left in the medicine cabinet can be a temptation for children and teenagers. Discard unused medications promptly. Do not flush drugs down the toilet or into the sink drain as they could be hazardous to the environment. Contact your local disposal company for more details about how to safely discard medications when they are expired or no longer needed. Big Red barrel and Yellow Jug are national drug disposal programs. Visit www.bigredbarrel.com

Expiration of your prescription & Beyond Use Date of the medication

• Refer to the label for the expiration date of your “prescription.”
• Your prescription expires in two ways:

1. One, you have used all the refills prescribed.
2. Two, the prescription has reached the expiration date of one year or six months for controlled drugs.

• Allow plenty of time to visit your doctor and for the pharmacist to compound our prescription renewal.
• Refer to the discard date or beyond use date on your bottle to learn when your “medication” should be discarded. Compounded medications have a shorter shelf life than those of manufactured drugs. The beyond use date is the longest date we can guarantee full potency of your medication.

Consumer Information Use and Disclaimer:

This information should not be used to decide whether or not to take this medication or any other medication. Only the healthcare provider has the knowledge and training to decide which medicines are right for a specific patient.This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about this medicine. It does not include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to this medicine.

For questions about the source of any of the information provided herein, pharmacists at Valiant Pharmacy are available. This information is not specific medical advice and does not replace information you receive from the healthcare provider. You must talk with the healthcare provider for complete information about the risks and benefits of this medicine.

Please contact Valiant Compounding Pharmacy at 734-545-1117 or toll free at 855-466-2583 with any questions or concerns about your medication.