Announcing: Advanced Diaper Reviews

In 2013, we first created the ADISC standardized diaper review format with a goal of creating a library of diaper reviews that had objective data and could be meaningfully compared to each other. 5 years later, I'm proud to and excited to announce a big step forward: ADISC is again raising the game on diaper reviews with what we've chosen to call "Advanced Diaper Reviews".

For this project, I reworked our testing protocol to generate far more robust data. Under our new protocol, our capacity testing data both includes more replicates of our previous quantitative test and adds a new and improved test – going forward, we will test all diapers with a new saline dosing test which borrows ideas from an existing industry test and yields more realistic real-world numbers. Using this new testing protocol, I've spent the past couple of months testing and re-testing nearly every ABDL diaper on the US market.

So, what does this mean in terms of releasing content?

(1) Today, we're releasing the summary data for the entire initial panel of ABDL diapers for this project, which you can read here. I think you're really going to want to read this because it includes charts like this:



(2) Over roughly the next 2 weeks, we'll be releasing one diaper review every day, in count-up order from least to most cost-efficient in the testing panel. Since we combine reviews for diapers that are the same except for print and a few Rearz and ABU products have different prints at different price points, this works out to 15 reviews. Half of these will be completely new, and half will be upgraded versions of previous reviews with our expanded testing results and other updates.

This means that our review of LittleForBig Little Trunks is being released today, which you can read here, and we'll finish with the release of our new Thrust Vector Crinklz review 15 days from now.

(3) After we finish releasing these reviews, stay tuned! There are a lot of diapers already announced for sale in the next few months.

I'm looking forward to getting my paws on PeekABU for a review very soon, and several other manufacturers including Tykables and Diaper Connoisseur have announced products for release in the next few months. There are also plans in the works to do a round-up of premium medical diapers and review any ABDL diapers readily available in the US that didn't make it into this January panel.

Announcing: Advanced Diaper Reviews

Announcing: Advanced Diaper Reviews

In 2013, we first created the ADISC standardized diaper review format with a goal of creating a library of diaper reviews that had objective data and could be meaningfully compared to each other. 5 years later, I'm proud to and excited to announce a big step forward: ADISC is again raising the game on diaper reviews with what we've chosen to call "Advanced Diaper Reviews".

For this project, I reworked our testing protocol to generate far more robust data. Under our new protocol, our capacity testing data both includes more replicates of our previous quantitative test and adds a new and improved test – going forward, we will test all diapers with a new saline dosing test which borrows ideas from an existing industry test and yields more realistic real-world numbers. Using this new testing protocol, I've spent the past couple of months testing and re-testing nearly every ABDL diaper on the US market.

So, what does this mean in terms of releasing content?

(1) Today, we're releasing the summary data for the entire initial panel of ABDL diapers for this project, which you can read here. I think you're really going to want to read this because it includes charts like this:



(2) Over roughly the next 2 weeks, we'll be releasing one diaper review every day, in count-up order from least to most cost-efficient in the testing panel. Since we combine reviews for diapers that are the same except for print and a few Rearz and ABU products have different prints at different price points, this works out to 15 reviews. Half of these will be completely new, and half will be upgraded versions of previous reviews with our expanded testing results and other updates.

This means that our review of LittleForBig Little Trunks is being released today, which you can read here, and we'll finish with the release of our new Thrust Vector Crinklz review 15 days from now.

(3) After we finish releasing these reviews, stay tuned! There are a lot of diapers already announced for sale in the next few months.

I'm looking forward to getting my paws on PeekABU for a review very soon, and several other manufacturers including Tykables and Diaper Connoisseur have announced products for release in the next few months. There are also plans in the works to do a round-up of premium medical diapers and review any ABDL diapers readily available in the US that didn't make it into this January panel.

Announcing: Advanced Diaper Reviews

OXYGEN Gas [Gilmore Liquid Air Company]

OXYGEN REFRIGERATED LIQUID USP UN1073  CONTENTS_________ LITERS  ALWAYS KEEP CONTAINER IN UPRIGHT POSITION.  WARNING: DO NOT CHANGE OR FORCE FIT CONNECTIONS.  EXTREMELY COLD LIQUID AND GAS UNDER PRESSURE.  VIGOROUSLY ACCELERATES COMBUSTION.  NO SMOKING IN THE PRESENCE OF OXYGEN OR A FIRE MAY RESULT.  COMBUSTIBLES IN CONTACT WITH LIQUID OXYGEN MAY EXPLODE ON IGNITION OR IMPACT.  CAN CAUSE SEVERE FROSTBITE.  KEEP OIL, GREASE AND COMBUSTIBLES AWAY.  USE ONLY WITH EQUIPMENT CLEANED FOR OXYGEN SERVICE.  STORE AND USE WITH ADEQUATE VENTILATION.  DO NOT GET LIQUID IN EYES, ON SKIN OR CLOTHING.  FOR LIQUID WITHDRAWAL, WEAR FACE SHIELD AND GLOVES.  DO NOT DROP.  USE SUITABLE HAND TRUCK FOR CONTAINER MOVEMENT.  AVOID SPILLS.  DO NOT WALK OR ROLL EQUIPMENT OVER SPILLS  CONTAINER TEMPERATURE SHOULD NOT EXCEED 52C (125 F)  CLOSE VALVE AFTER EACH USE AND WHEN EMPTY.  USE A BACK FLOW PREVENTATIVE DEVICE IN THE PIPING.  USE IN ACCORDANCE WITH THE MATERIAL SAFETY DATA SHEET (MSDS)  

FIRST AID: IN CASE OF FROSTBITE OBTAIN MEDICAL TREATMENT IMMEDIATELY.

WARNING: FOR EMERGENCY USE ONLY WHEN ADMINISTERED BY PROPERLY TRAINED PERSONNEL FOR OXYGEN DEFICIENCY AND RESUSCITATION.  FOR ALL OTHER MEDICAL APPLICATIONS Rx ONLY.  UNINTERRUPTED USE OF HIGH CONCENTRATIONS OF OXYGEN OVER A LONG DURATION WITHOUT MONITORING ITS EFFECT ON OXYGEN CONTENT OF ARTERIAL BLOOD MAY BE HARMFUL.  USE ONLY WITH PRESSURE REDUCING EQUIPMENT AND APPARATUS DESIGNED FOR OXYGEN.  DO NOT ATTEMPT TO USE ON PATIENTS WHO HAVE STOPPED BREATHING, UNLESS USED IN CONJUNCTION WITH RESUSCITATIVE EQUIPMENT.  PRODUCED BY AIR LIQUEFACTION.  DO NOT REMOVE THIS PRODUCT LABEL.

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OXYGEN Gas [Gilmore Liquid Air Company]

ZENIQUIN (Marbofloxacin) Tablet [Zoetis Inc.]

Marbofloxacin is rapidly and almost completely absorbed from the gastrointestinal tract following oral administration to fasted animals. Divalent cations are generally known to diminish the absorption of fluoroquinolones. The effects of concomitant feeding on the absorption of marbofloxacin have not been determined. (See Drug Interactions.) In the dog, approximately 40% of an oral dose of marbofloxacin is excreted unchanged in the urine1. Excretion in the feces, also as unchanged drug, is the other major route of elimination in dogs. Ten to 15% of marbofloxacin is metabolized by the liver in dogs.

In vitro plasma protein binding of marbofloxacin in dogs was 9.1% and in cats was 7.3%. In the cat, approximately 70% of an oral dose is excreted in the urine as marbofloxacin and metabolites with approximately 85% of the excreted material as unchanged drug. Pharmacokinetic parameters related to intravenous dosing were estimated in a study of 6 healthy adult beagle dogs, and are summarized in Table 1. The absolute bioavailability following dosing of oral tablets to the same animals was 94%.

Marbofloxacin plasma concentrations were determined over time in healthy adult beagle dogs (6 dogs per dosage group) following single oral doses of 1.25 mg/lb or 2.5 mg/lb. Absorption of orally administered marbofloxacin increases proportionally over the dose range of 1.25 to 2.5 mg/lb. Marbofloxacin plasma concentrations were determined over time in 7 healthy adult male cats following a single oral dose of 2.5 mg/lb. Plasma pharmacokinetic parameters following oral dosing of dogs and cats are summarized in Figures 2 and 3 and in Table 2. Based on the terminal elimination half-life and the dosing interval, steady-state levels are reached after the third dose and are expected to be approximately 25% greater in dogs and 35% greater in cats than those achieved after a single dose. Marbofloxacin is widely distributed in canine tissues. Tissue concentrations of marbofloxacin were determined in healthy male beagle dogs (4 dogs per time period) at 2, 18 and 24 hours after a single oral dose (1.25 or 2.5 mg/lb) and are summarized in Tables 3a and 3b.

Table 1: Mean pharmacokinetic parameters following intravenous administration of marbofloxacin to 6 adult beagle dogs at a dosage of 2.5 mg/lb.

* SD = standard deviation

Table 2: Mean pharmacokinetic parameters following oral administration of marbofloxacin tablets to adult beagle dogs at a nominal dosage of 1.25 mg/lb or
2.5 mg/lb and to cats at 2.5 mg/lb.†

† mean actual dosages administered to dogs were 1.22 mg/lb and 2.56 mg/lb, respectively, and the mean
actual dosage administered to cats was 2.82 mg/lb.
* SD = standard deviation

Figure 2: Mean plasma concentrations (µg/mL) following single oral administration of marbofloxacin to adult beagle dogs at dosages of 1.25 mg/lb or 2.5 mg/lb.

* See Table 4 in Microbiology section for MIC data.

Figure 3: Mean plasma concentrations (µg/mL) following single oral administration of marbofloxacin to adult cats at a dosage of 2.5 mg/lb.

* See Table 5 in Microbiology section for MIC data.

Table 3a: Tissue distribution following a single oral administration of marbofloxacin tablets to adult beagle dogs at a dosage of 1.25 mg/lb*.

* SD = standard deviation

Table 3b: Tissue distribution following a single oral administration of marbofloxacin tablets to adult beagle dogs at a dosage of 2.5 mg/lb.

* SD = standard deviation

Microbiology

The primary action of fluoroquinolones is to inhibit the bacterial enzyme, DNA gyrase. In susceptible organisms, fluoroquinolones are rapidly bactericidal at relatively low concentrations. Marbofloxacin is bactericidal against a broad range of gram-negative and gram-positive organisms. The minimum inhibitory concentrations (MICs) of pathogens isolated in clinical field studies performed in the United States were determined using National Committee for Clinical Laboratory Standards (NCCLS) standards, and are shown in Tables 4 and 5.

Table 4. MIC Values* (μg/mL) of marbofloxacin against pathogens isolated from skin, soft tissue and urinary tract infections in dogs enrolled in clinical studies conducted during 1994–1996.

* The correlation between in vitro susceptibility data (MIC) and clinical response has not been
determined.
** MIC50 and MIC90 not calculated due to insufficient number of isolates.

Table 5: MIC Values* (μg/mL) of marbofloxacin against pathogens isolated from
skin and soft tissue infections in cats enrolled in clinical studies conducted in 1995
and 1998.

* The correlation between in vitro susceptibility data (MIC) and clinical response has not been
determined.

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ZENIQUIN (Marbofloxacin) Tablet [Zoetis Inc.]

BETAMETHASONE DIPROPIONATE Cream, Augmented [E. Fougera Co. A Division Of Fougera Pharmaceuticals Inc.]

Betamethasone Dipropionate Cream USP (Augmented), 0.05% contains betamethasone dipropionate USP, a synthetic adrenocorticosteroid, for topical use in a white to off-white cream base. Betamethasone, an analog of prednisolone, has a high degree of corticosteroid activity and a slight degree of mineralocorticoid activity. Betamethasone dipropionate is the 17,21-dipropionate ester of betamethasone.

Chemically, betamethasone dipropionate is 9-fluoro-11β,17,21-trihydroxy-16β-methylpregna-1,4-diene-3,20-dione 17,21-dipropionate, with the molecular formula C28H37FO7, a molecular weight of 504.6, and the following structural formula:

Betamethasone dipropionate is a white to creamy white, odorless crystalline powder, insoluble in water.

Each gram of Betamethasone Dipropionate Cream USP (Augmented), 0.05% contains: 0.643 mg betamethasone dipropionate, USP (equivalent to 0.5 mg betamethasone) in a white to off-white cream base of purified water, chlorocresol, white petrolatum, white wax (beeswax), cyclomethicone, sorbitol solution, glyceryl monooleate, propylene glycol, ceteareth-30, carbomer 980, and sodium hydroxide.

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BETAMETHASONE DIPROPIONATE Cream, Augmented [E. Fougera Co. A Division Of Fougera Pharmaceuticals Inc.]

METFORMIN HYDROCHLORIDE Tablet, Extended Release [AvKARE, Inc.]

Store at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature]. Keep tightly closed (protect from moisture). Protect from light. Avoid excessive heat and humidity.

Mfg. Rev. 02/16

PATIENT INFORMATION ABOUT

Metformin Hydrochloride Extended-release Tablets

 (met-FOR-min HYE-droe-KLOR-ide)

Q1. Why do I need to take metformin hydrochloride extended-release tablets?

Your doctor has prescribed metformin hydrochloride extended-release tablets to treat your type 2 diabetes, a condition in which blood sugar (blood glucose) is elevated. There are two types of diabetes. Metformin hydrochloride extended-release tablets are indicated for the most common type, known as type 2 diabetes.

Q2. Why is it important to control type 2 diabetes?

Type 2 diabetes has multiple possible complications, including blindness, kidney failure, and circulatory and heart problems. Lowering your blood sugar to a normal level may prevent or delay these complications.

Q3. How is type 2 diabetes usually controlled?

High blood sugar can be lowered by diet and exercise, by a number of oral medications and by insulin injections. Your doctor may recommend that you try lifestyle modifications such as improved diet and exercise before initiating drug treatment for type 2 diabetes. Each patient will be treated individually by his or her physician, and should follow all treatment recommendations.

Q4. Do metformin hydrochloride extended-release tablets work differently from other glucose control medications?

Yes. Metformin hydrochloride extended-release tablets, as well as other formulations of metformin, lowers the amount of sugar in your blood by controlling how much sugar is released by the liver. Metformin hydrochloride extended-release tablets do not cause your body to produce more insulin. Metformin hydrochloride extended-release tablets rarely causes hypoglycemia (low blood sugar) and it does not usually cause weight gain when taken alone. However, if you do not eat enough, if you take other medications to lower blood sugar, or if you drink alcohol, you can develop hypoglycemia. Specifically, when metformin hydrochloride extended-release tablets is taken together with a sulfonylurea or with insulin, hypoglycemia and weight gain are more likely to occur.

Q5. What happens if my blood sugar is still too high?

If your blood sugar is high, consult your physician. When blood sugar cannot be lowered enough by either metformin hydrochloride extended-release tablets or a sulfonylurea, the two medications can be effective when taken together. Other alternatives involve switching to other oral antidiabetic drugs (e.g., alpha glucoside inhibitors or glitazones). Metformin hydrochloride extended-release tablets may be stopped and replaced with other drugs and/or insulin. If you are unable to maintain your blood sugar with diet, exercise and glucose-control medications taken orally, then your doctor may prescribe injectable insulin to control your diabetes.

Q6. Why should I take metformin hydrochloride extended-release release tablets in addition to insulin if I am already on insulin alone?

Adding metformin hydrochloride extended-release tablets to insulin can help you better control your blood sugar while reducing the insulin dose and possibly reducing your weight.

Q7. Can metformin hydrochloride extended-release tablets cause side effects?

Metformin hydrochloride extended-release tablets, like all blood sugar-lowering medications, can cause side effects in some patients. Most of these side effects are minor and will go away after you've taken metformin hydrochloride extended-release tablets for a while. However, there are also serious but rare side effects related to metformin hydrochloride extended-release tablets (see below).

Q8. What kind of side effects can metformin hydrochloride extended-release tablets cause?

If side effects occur, they usually occur during the first few weeks of therapy. They are normally minor ones such as diarrhea, nausea, abdominal pain and upset stomach. Metformin hydrochloride extended-release tablets are generally taken with meals, which reduce these side effects.

Although these side effects are likely to go away, call your doctor if you have severe discomfort or if these effects last for more than a few weeks. Some patients may need to have their doses lowered or stop taking metformin hydrochloride extended-release tablets, either temporarily or permanently. You should tell your doctor if the problems come back or start later on during the therapy.

WARNING: A rare number of people who have taken metformin have developed a serious condition called lactic acidosis. Properly functioning kidneys are needed to help prevent lactic acidosis. You should not take metformin hydrochloride extended-release tablets if you have impaired kidney function, as measured by a blood test (see Q9-13).

Q9. Are there any serious side effects that metformin hydrochloride extended-release tablets can cause?

Metformin hydrochloride extended-release tablets rarely cause serious side effects. The most serious side effect that metformin hydrochloride extended-release tablets can cause is called lactic acidosis.

Q10. What is lactic acidosis and can it happen to me?

Lactic acidosis is caused by a build-up of lactic acid in the blood. Lactic acidosis associated with metformin is rare and has occurred mostly in people whose kidneys were not working normally. Lactic acidosis has been reported in about one in 33,000 patients taking metformin over the course of a year. Although rare, if lactic acidosis does occur, it can be fatal in up to half the cases.

It is also important for your liver to be working normally when you take metformin hydrochloride extended-release tablets. Your liver helps to remove lactic acid from your bloodstream. Your doctor will monitor your diabetes and may perform blood tests on you from time to time to make sure your kidneys and your liver are functioning normally. There is no evidence that metformin hydrochloride extended-release tablets causes harm to the kidneys or liver.

Q11. Are there other risk factors for lactic acidosis?

Your risk of developing lactic acidosis from taking metformin hydrochloride extended-release tablets is very low as long as your kidneys and liver are healthy. However, some factors can increase your risk because they can affect kidney and liver function. You should discuss your risk with your physician. You should not take metformin hydrochloride extended-release tablets if:

• You have some forms of kidney or liver problems
• You have congestive heart failure which is treated with medications, e.g., digoxin (Lanoxin ®) or furosemide (Lasix ®)
• You drink alcohol excessively (all the time or short-term "binge" drinking)
• You are seriously dehydrated (have lost a large amount of body fluids)
• You are going to have, within a few days, certain x-ray tests with injectable contrast agents
• You are going to have surgery
• You develop a serious condition such as a heart attack, severe infection, or a stroke
• You are 80 years of age or older and have NOT had your kidney function tested

Q12. What are the symptoms of lactic acidosis?

Some of the symptoms include feeling very weak, tired or uncomfortable, unusual muscle pain, trouble breathing, unusual or unexpected stomach discomfort, feeling cold, feeling dizzy or lightheaded, or suddenly developing a slow or irregular heartbeat. If you notice these symptoms, or if your medical condition has suddenly changed, stop taking metformin hydrochloride extended-release tablets and call your doctor right away. Lactic acidosis is a medical emergency that must be treated in a hospital.

Q13. What does my doctor need to know to decrease my risk of lactic acidosis?

Tell your doctor if you have an illness that results in severe vomiting, diarrhea and/or fever, or if your intake of fluids is generally reduced. These situations can lead to severe dehydration, and it may be necessary to stop taking metformin hydrochloride extended-release tablets temporarily. You should let your doctor know if you are going to have any surgery or specialized x-ray procedures that require injection of contrast agents. Metformin hydrochloride extended-release tablets therapy will need to be stopped temporarily in such instances.

Q14. Can I take metformin hydrochloride extended-release tablets with other medications?

Remind your doctor and/or pharmacist that you are taking metformin hydrochloride extended-release tablets when any new drug is prescribed or a change is made in how you take a drug already prescribed. Metformin hydrochloride extended-release tablets may interfere with the way some drugs work and some drugs may interfere with the action of metformin hydrochloride extended-release tablets.

Q15. What if I become pregnant while taking metformin hydrochloride extended-release tablets?

Tell your doctor if you plan to become pregnant or have become pregnant. As with other oral glucose-control medications, you should not take metformin hydrochloride extended-release tablets during pregnancy. Usually your doctor will prescribe insulin while you are pregnant.

Q16. How do I take metformin hydrochloride extended-release tablets?

Metformin hydrochloride extended-release tablets should not be cut, crushed, or chewed and should be taken whole with a full glass of water once daily with the evening meal. Occasionally, the inactive ingredients of metformin hydrochloride extended-release tablets may be eliminated as a soft mass in your stool that may look like the original tablet; this is not harmful and will not effect the way metformin hydrochloride extended-release tablets works to control diabetes. Metformin hydrochloride extended-release tablets should be taken once a day with food. You will be started on a low dose of metformin hydrochloride extended-release tablets and your dosage will be increased gradually until your blood sugar is controlled.

Q17. Where can I get more information about metformin hydrochloride extended-release tablets?

This leaflet is a summary of the most important information about metformin hydrochloride extended-release tablets. If you have any questions or problems, you should talk to your doctor or other healthcare provider about type 2 diabetes as well as metformin hydrochloride extended-release tablets and its side effects.

Manufactured for:

Manufactured for:
AvKARE, Inc.
Pulaski, TN 38478

Mfg. Rev. 02/16
AV 01/17 (P) 

                                                  

           

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METFORMIN HYDROCHLORIDE Tablet, Extended Release [AvKARE, Inc.]