Why must prasugrel (Effient) be stored in the original bottle?

Prasugrel (Effient) is a new platelet inhibitor manufactured by Eli Lilly. During the review process by the FDA it was discovered that the base form of the medication was not as well absorbed by patients on proton-pump inhibitors or H2 antagonists (both increase the gastric PH). So the company developed a salt form of the medication prasugrel HCL which is better absorbed at high PH.

In addition, the company discovered during the quality control process of their manufacturing that a reaction occurs (strongly correlated with temperature and high humidity) that drug degrades from the salt form to the base form. Analysis was completed it was found that the Cmax is delayed, when the base form is administered in patients with high PH, which theoretically could have clinical significance as it delays the time of maximal platelet inhibition. No clinical significance of the conversion from salt to base was described in analysis submitted to the FDA in terms of outcomes from the clinical trials. Even in situations of high conversion to the base, and high PH, the pharmacodynamic effects of prasugrel were superior to clopidogrel.

This type of manufacturing quality control examination has not occurred with all medications and the extent of conversion from salt to base forms for other medications is unknown. The company has packed the medication to minimize the potential impact of the conversion of salt to base by recommending storage in the original bottle and the addition of a desiccant to control humidity.

It is currently available as 5mg tablets (bottles of 7 and 30) and 10mg tablets (bottles of 30 and unit-dose blisters 90). This leads to challenges for hospitals that dispense medications in unit-dose tablets as the 5mg tablets are not available in a unit-dose formulation. This has implications for patient safety as the manufacturer currently recommends against repackaging their product. Pharmacists are awaiting the release of a 5mg unit dose product or clarification from the company about repackaging.

How do I take suboxone?

Suboxone enters the bloodstream under the tongue.

To help get the best adsorption into the blood you should take the following steps:

1. Drink some water to moisten your mouth... it will help the tablets dissolve more easily

2. Place the tablet under your tongue, if your dose is two tablets place one tablet on the left side and one on the right side (a mirror may help with the placement), and lean your head slightly forward.

3. Do not dissolve more than 2 tablets at a time, if your prescribed dose is more than 2 tablets, dissolve 2 tablets first and put the next tablets in after the first tablets have completely dissolved.

4. It will take about 5 to 10 minutes for the tablets to dissolve.

5. DO NOT chew or swallow the tablets, DO NOT talk while the tablets dissolve, as you will not get the correct dose and it will not work as well.

What are the side effects of suboxone?

Suboxone is used for the treatment of addiction to opioids (drugs like morphine, heroin, oxycodone). The side effects caused by the medication are difficult to discern from side effects commonly seen with the use of opioids and symptoms of withdrawal.

The most commonly reported side effects with the use of this medication in clinical trials were: headache, withdrawal syndrome, pain, nausea, constipation, insomnia, hypotension (low blood pressure), and dizziness.

Important safety information about TREN-Xtreme, MASS Xtreme, ESTRO Xtreme, AH-89-Xtreme, HMG Xtreme, MMA-3 Xtreme, VNS-9 Xtreme, and TT-44-Xtreme

Important safety information has been released by the FDA that the following products: TREN-Xtreme, MASS Xtreme, ESTRO Xtreme, AH-89-Xtreme, HMG Xtreme, MMA-3 Xtreme, VNS-9 Xtreme, and TT-40-Xtreme contain steroids.

Serious adverse events are associated with the use of these products and other similar products include: liver injury, stroke, kidney failure and pulmonary embolism (blockage of an artery in the lung). It is recommended that you immediately stop using all body building products that claim to contain steroids or steroid-like substances. Consult a health care professional if you are experiencing symptoms possibly associated with these products, particularly nausea, weakness or fatigue, fever, abdominal pain, chest pain, shortness of breath, jaundice (yellowing of the skin or whites of the eyes) or brown/discolored urine.

This type of misbranding (including ingredients in a product that are not listed on the label) is common among dietary supplements. One hypothesis for some professional athletes (e.g. major league baseball players) testing positive for steroids is the use of dietary supplements such as these that contain steroids not listed on the label.

Saftey Alert Leukotriene Inhibitors: Montelukast (Singulair), Zafirlukast (Accolate), Zileuton (Zyflo and Zyflo CR)

The FDA has provided healthcare professionals with updated information about the ongoing safety review for the leukotriene inhibitors, montelukast, zafirlukast and zileuton. Neuropsychiatric events have been reported in some patients taking montelukast (Singulair), zafirlukast (Accolate), and zileuton (Zyflo and Zyflo CR). FDA has requested that manufacturers include a precaution in the drug prescribing information. The reported neuropsychiatric events include postmarket cases of agitation, aggression, anxiousness, dream abnormalities and hallucinations, depression, insomnia, irritability, restlessness, suicidal thinking and behavior (including suicide), and tremor.

• Patients and healthcare professionals should be aware of the potential for neuropsychiatric events with these medications.
• Patients should talk with their healthcare providers if these events occur.
• Healthcare professionals should consider discontinuing these medications if patients develop neuropsychiatric symptoms.

Update - Why is there a shortage of desiccated thyroid (e.g. Armour thyroid, Thyroid (dessicated), Nature-Throid, Westhroid, Thyrolar))

The tincture of time has not helped to resolve the shortage. In fact, since my last post, the shortage has worsened leaving patients with few options to manage diseases of low thyroid.

Reason for the Shortage

• Several thyroid (desiccated) products have been discontinued. The manufacturers would not provide a reason for the discontinuations; however these products are not FDA-approved. Forest states that the shortage of Armour Thyroid is due to a shortage of raw material. Major and RLC will not provide a reason for the shortage.

Estimated Resupply Dates

Major has all strengths on back order and the company cannot estimate a release date.

Forest has available Armour Thyroid 240 mg and 300 mg tablets. All other strengths are on back order and the company cannot estimate a release date.

RLC has all presentations of Nature-Throid on back order and the company estimates a release date of early-December, 2009.

RLC also has all presentations of Westhroid on back order and the company estimates a release date of early-December, 2009.

Products in short supply

Thyroid (desiccated) 120 mg tablets, Major - discontinued
Thyroid (desiccated) 30 mg tablets, Major
Thyroid (desiccated) 30 mg tablets, Major
Thyroid (desiccated) 60 mg tablets, Major
Thyroid (desiccated) 60 mg tablets, Major
Thyroid (desiccated) 120 mg tablets, Major
Thyroid (desiccated) 180 mg tablets, Major

Armour Thyroid 15 mg tablets, Forest
Armour Thyroid 30 mg tablets, Forest
Armour Thyroid 30 mg tablets, unit dose, Forest
Armour Thyroid 30 mg tablets, Forest
Armour Thyroid 60 mg tablets, Forest
Armour Thyroid 60 mg tablets, unit dose, Forest
Armour Thyroid 60 mg tablets, Forest
Armour Thyroid 90 mg tablets, Forest
Armour Thyroid 120 mg tablets, Forest
Armour Thyroid 120 mg tablets, unit dose,Forest
Armour Thyroid 120 mg tablets, Forest
Armour Thyroid 180 mg tablets, Forest
Armour Thyroid 180 mg tablets, Forest

Nature-Throid NT-1/4 16.25 mg (1/4 grain) tablets, RLC
Nature-Throid NT-1/2 32.4 mg (1/2 grain) tablets, RLC
Nature-Throid NT-1 64.8 mg (1 grain) tablets, RLC
Nature-Throid NT-2 129.6 mg (2 grain) tablets, RLC
Nature-Throid NT-3 194.4 mg (3 grain) tablets, RLC

Westhroid 32.5 mg (1/2 grain) tablets, RLC
Westhroid 32.5 mg (1/2 grain) tablets, RLC
Westhroid 65 mg (1 grain) tablets, RLC
Westhroid 65 mg (1 grain) tablets, RLC
Westhroid 130 mg (2 grain) tablets, RLC
Westhroid 130 mg (2 grain) tablets, RLC

Thyrolar tablets, Forest Laboratories - all strengths
12.5/3.1, 25/6.25, 50/12.5, 100/25, 150/37.5

Discontinued Products

Thyroid (desiccated) capsules (Bio-Tech Pharm) - discontinued
Thyroid (desiccated) tablets (Qualitest) - discontinued
Thyroid (desiccated) tablets (Time-Cap) - discontinued