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(last updated May 2016)
There are many concerns today over how education technology companies protect data and whether they profit from the sale of that data or advertising. From its launch in 2004, School Loop has never and will never sell any student or parent data (or any system data for that matter). We don't sell ads or carry advertising. And we regularly review and update our industry-standard security practices and systems.
This document discusses data security in general, FERPA compliance, and the requirements of AB1584, SB177 SOPIPA Compliance.
With regards to FERPA and the use of School Loop, in general, districts are guided by the U.S. Department of Ed's ruling on Edline and the Clark County School District (Las Vegas, Nevada). http://www.ed.gov/policy/gen/guid/fpco/ferpa/library/clarkcty062806.html. Edline was competitor offering similar services. The Department of Education conclusion is as follows:
Based on the information provided, it appears that the arrangement schools within the District have with Edline meets these requirements for disclosing specified information from education records to Edline as a "school official" under this FERPA exception. In particular, 1) Edline provides online hosting services that permit parents to view some of their children's education records, and Edline uses the information from education records to perform those services that would otherwise be provided by school employees; 2) Edline's online access services provide it with "legitimate educational interests" in the information disclosed to Edline by each school; and 3) Edline's use and maintenance of personally identifiable information from education records is subject to the direct control of each school within the District. Each school or the District must ensure that Edline does not redisclose or permit the redisclosure of any personally identifiable information from education records except as specifically authorized by the school or District that is responsible for the contract. The school (or District), in turn, remains responsible for any FERPA violations committed by its service provider. In that regard, we note that Edline takes reasonable and appropriate steps to ensure that information from education records is not disclosed or made available to other parties and does not use the information for any other purpose.
Based on this guidance, districts in California and across the country use systems like School Loop and stay within the law.
As noted, School Loop offers a variety of account types and settings that help districts enforce their policies. These accounts have access to different types of content. Access to those accounts can be controlled in various ways.
School Loop offers roles for certificated employees (teachers, principals, and certificated staff), classified employees (we call those accounts Associates), parents, students, and a class of account we label Afterschool Professional (ASP). ASP accounts are optional for districts and allow districts and parents to approve accounts for tutors, social workers, people who run after school programs, and others they deem fit.
Parents and students can only see their own grades and attendance information, and other such information published specifically to them as members of classes and schools. Parents and students self-register, and districts are given the choice of approving each account before any access is granted (approval being whatever process they set up to verify that the registrant is legit), or allowing limited access to parents and requiring verification for grades and attendance. Additionally, all parents and students have a tool that allows them to challenge the membership of any other person who registers as a parent. This Challenge tool sends an alert to administrators, and admins can then suspend or delete the account, ignore the challenge, or ask for more information.
Classified staff have no access to individual student data. ASPs need to be approved by the parent to gain access at one of two levels. One level gives ASPs access to homework information, and the ability to send email to the other members of the students Learning Management Team -- a student's teachers and parents, and any other member of staff that has joined the team. A higher level of access set by the school allows ASPs the same access as certificated employees (see below).
Certificated employees by default have access to all student grades and attendance, homework information, submitted work, a digital locker than can contain pertinent information about that student (accommodations, for instance), and a threaded "Intervention" discussion group -- a way that members of the Learning Management Team can discuss a student. That access can be turned off for certificated employees as well.
The combination of account types, access rights, control over account registration, and control over access to content has proved successful at helping hundreds of districts enforce their privacy policies in different ways. In addition, there are a variety of fine-tuning settings that allow you to further limit access, mask the identity of a student, and restrict parent accounts for students.
Over our history, we have repeatedly refined these tools to help districts use School Loop safely and within their policy guidelines. We are quite concerned over privacy and protecting students, and take our responsibilities to do so seriously.
School Loop implements industry-standard security procedures for storing and accessing informationto avoid the loss or theft of any data, with an emphasis on protecting personal data, defined as login credentials, permanent student IDs, addresses, phone numbers. If we detect a breach involving the loss or theft of personal data our notification plan is as follows:
Within 24 hours:
Upon resolution:
Within 60 days (CA only):


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Postal Explorer >
- International Mail Manual >
Individual Country Listings
Afghanistan - Belgium
Prohibitions (130)
Coins; banknotes; currency notes (paper money); securities payable to bearer; platinum, gold or silver, manufactured or not.
Infectious materials.
Perishable biological substances.
Radioactive materials.
Traveler's checks, precious stones, jewelry, and other valuable articles are admitted only in registered First-Class Mail International shipments.
First-Class Mail International shipments may not contain dutiable articles.
Customs Forms Required (123)
First-Class Mail International items and Priority Mail International Flat Rate Envelopes and Small Flat Rate Priced Boxes: PS Form 2976 (see 123.61)
Priority Mail International parcels:PS Form 2976-A inside 2976-E (envelope)
Global Express Guaranteed (210) Price Group 6
Refer to Notice 123, Price List, for the applicable retail, commercial base, or commercial plus price.
Weight Limit: 70 lbs.
Insurance (212.5)
Insured Amount
not over
No Fee
For document reconstruction insurance or non-document insurance coverage above $800, add $1.00 per $100 or fraction thereof, up to a maximum of $2,499 per shipment.
$2,499 max.
Value Limit (212.1)
The maximum value of a GXG shipment to this country is $2,499 or a lesser amount if limited by content or value.
Size Limits (211.22)
The surface area of the address side of the item to be mailed must be large enough to completely contain the GlobalExpress Guaranteed Air Waybill/Shipping Invoice (shipping label), postage, endorsement, and any applicable markings.The shipping label is approximately 5.5 inches high and 9.5 inches long.
Maximum length: 46 inchesMaximum width: 35 inchesMaximum height: 46 inchesMaximum length and girth combined: 108 inches
General Conditions for Mailing
See Publication 141, Global Express Guaranteed Service Guide, for information about areas served in the destination country, allowable contents, packaging and labeling requirements, tracking and tracing, service standards, and other conditions for mailing.
Express Mail International (220)
Not Available
Priority Mail International (230) Price Group 6
Weight Limit: 66 lbs.
Note: Ordinary Priority Mail International includes indemnity at no cost based on weight. (See 230.)
Priority Mail International — Flat Rate
Flat Rate Envelopes or Small Flat Rate Priced Boxes: The maximum weight is 4 pounds. Refer to Notice 123, Price List, for the applicable retail, commercial base, or commercial plus price.
Flat Rate Boxes — Medium and Large: The maximum weight is 20 pounds, or the limit set by the individual country, whichever is less. Refer to Notice 123, Price List, for the retail, commercial base, or commercial plus price.
Insurance (232.92)
NOT Available
Size Limits (231.22)
Maximum length: 42 inches
Maximum length and girth combined: 79 inches
First-Class Mail International (240) Price Group 6
For the prices and maximum weights for letters, large envelopes (flats), packages (small packets), and postcards, see Notice 123, Price List.
Size Limits
Letters: See 241.212
Postcards: See 241.221
Large Envelopes (Flats): See 241.232
Packages (Small Packets): See 241.242 and 241.243
Airmail M-bags (260) —
Direct Sack to One Addressee Price Group 6
Weight Limit: 66 lbs.
Matter for the Blind (270)
Free when sent as First-Class Mail International, including Priority Mail International Flat Rate Envelopes and Small Flat Rate Priced Boxes. Weight limit: 4 pounds.
Free when sent as Priority Mail International. Weight limit: 15 pounds.
Extra Services
Certificate of Mailing (313)
Individual Pieces
Individual article (PS Form 3817)
Firm mailing books (PS Form 3877), per article listed (minimum 3)
Duplicate copy of PS Form 3817 or PS Form 3877 (per page)
Bulk Quantities
First 1,000 pieces (or fraction thereof)
Each additional 1,000 pieces (or fraction thereof)
Duplicate copy of PS Form 3606
COD and Certified
NOT for International Mail
International Business Reply Service (382)
Fee: Envelopes up to 2 ounces $1.50; Cards $1.00
International Postal Money Order (371)
International Reply Coupons (381)
Fee: $2.20
Registered Mail (330)
Fee: $11.75
Maximum Indemnity: $47.33
Available for First-Class Mail International, including postcards and Flat Rate Envelopesand Small Flat Rate Priced Boxes, and matterfor the blind or other physically handicapped persons. Not applicable to M-bags.
Restricted Delivery (350)
Return Receipt (340)
Fee: $2.35
Available for registered mail only.

subset: commoncrawl


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FsM v27 MIUI theme with 3D icons for Xiaomi and Redmi phones
Hi Xiaomi and Redmi fans, today I'm sharing a new MIUI theme FsM v27 for your MIUI phone. This MIUI theme can change the look of your Xiaomi, Redmi and POCO phone, personalize your phone with awesome look and make it different with others.
FsM v27 MIUI theme is an attractive theme for your Xiaomi and Redmi phone. It bring you the new well designed icons, fresh wallpapers, new status bar, cool lock screen, stylish Always-on Display and many other great changes which you'll love using it on your smartphone. This Xiaomi theme is completely free to use, so just download and apply it making a good feeling everyday.
FsM v27 MIUI theme is compatible with MIUI 14, MIUI 13, MIUI 12 and works on Xiaomi, Redmi and POCO smartphones. If you like to try new themes on your smartphone and want a different look over your stock themes, then just download the FsM v27 MIUI theme and share it to others.
FsM v27 MIUI Theme Preview
FsM v27 MIUI Theme Details
- Theme Size: 17.27 MB
- Designer: Taha2
- Region/Server: Global
- Compatibility: MIUI 14, MIUI 13, MIUI 12.5 and MIUI 12
Theme's description:
Theme support miui 12,/13 and miui 14
Designer by Taha2
For feedback
e-mail = [email protected]
You may also like: Best MIUI Theme You Should Try [2023]
How to Apply MIUI Themes [Stock Roms]
If you have MIUI Global Stable ROM(Stock ROM) running on your device, please follow this instruction to install and apply the theme.
- Open this page with Firefox browser.
- Click the "Official Theme Store Link" in the download area.
- This will open a xiaomi theme page in Chinese language, then open the 3 dots in the right corner, select "Open in app".
- It will open the Theme Store APP "Themes Store" to download the theme.
- Download and Apply the theme.
If you have MIUI 14 ROM, please follow this instruction to install and apply the theme.
Note: If the "Official Theme Store Link" does not work then please open this page in Chrome Browser or the Default Xiaomi Browser and try again, the other browsers may not work.
How to Apply MIUI Themes on [Custom ROMs]
If you have any MIUI 11, 12, 12.5, 13 or MIUI 14 based custom ROMs like Xiaomi EU ROM, MIUIRoom and others, you can install MIUI theme with MTZ file.
- Download the mtz theme file from the download link.
- Open the Theme Store APP and tap to Themes option.
- Swipe to bottom and click Import.
- Import the xxx.mtz file just downloaded.
- Apply the theme.


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L'Amour Le Allure
Instagram: Lamour_le_allure
Updated 3/8/2023
Rose Gold Roman Goddess Top and Skirt with Rhinestone Fringe
Regular price $415.00
Unit price
Shipping calculated at checkout.
Welcome to L'Amour Le Allure
Sample item Information:
- Most sample items can be remade in any size that includes plus size!
- Recreation may vary depending on available supplies and due date
- Please specify if you would like any changes to the design such as colors, beading, trim...etc
- Send us a custom request from this listing with all your information (name, size(bra/bottom), padded or non-padded) and any changes you would like)
For all custom orders and made to order items please read below:
- We will create all custom outfits using your bra size and personal measurements
- Prices may vary depending on materials, time needed to create items and complexity of the item itself
- Larger bras/corsets may cost more to create due to amount of material used
- Custom orders and made to order items take from 1 Day to 8 weeks to make
Instagram: Lamour_le_allure
Facebook: L'Amour Le Allure
Updated 3/8/2023


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Karom Kilim Cushion E00373 Lumbar Pouf Southern Geometric Garden
Karom Kilim Cushion E00373 Lumbar Pouf Southern Geometric Garden
Sale Sold out
Regular price $71.00 USD
Regular priceUnit price per
Sale price
Kilim Pillow Cover Size: 16x24 inches / 40x60 cm.
Turkish Pillow Case Materials: Vintage Turkish handwoven kilim rug panel (40-90 years old) on the front, 100% cotton fabric on the back with a hidden zipper.
Pillow sham only, no insert pillows or materials included.
Square Kilim Pillow Covers:
Rectangular Kilim Pillow Covers:
Perfect Turkish item for, vintage, boho, bohemian, ethnic, tribal, rustic, southwestern, authentic, antique, shabby chic, modern decor styles.


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Peached Cotton Canvas Bucket Hat for Men in Yellow
This peached cotton canvas bucket hat will be your new summertime staple. With a casual look and fresh design, it's made up of 100% cotton, and has a comfy cotton sheeting sweatband.
We offer a range of delivery options, depending on the service that suits your personal needs. Find out more by reading below about the services offered by Timberland.
Standard Delivery
Standard service, delivered within 5 working days.
Delivery is Monday to Saturday.
Standard delivery is free for all orders above £100.
Returning an item to us is quick, easy and free. If for any reason you are not happy with a product you've purchased, you can return it to us within 30 days for a refund. Once we've inspected the item, we'll refund the price you paid, back to your original payment method.
In Store Availability
Use your location or enter your city / zip code to find the nearest stores
STORES - Available as of 08 December 2023 21:35:46 EST


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The milk from the evening is left to rest overnight in containers, letting the cream come to the surface in a natural way. This milk is partially skimmed in the morning and then mixed with the morning's whole milk. Only milk and rennet of organic origin are mixed in large copper kettles from which, after heating and coagulation, the wheels will be made. Every day, 10 wheels of Parmigiano Reggiano are made. For a kilo of Parmigiano Reggiano to be made, 17 liters of milk will be used. The cheese is immersed in brine for 21 days, then turned, cleaned and seasoned for 24 months.
We had the good fortune to sample this cheese at the SANA in Bologna. We were bowled over by the incredible sweet, floral, fruity fragrance and the rich, pure flavor. Clearly, the additional work needed to achieve an organic product, the small scale of the co-op and the unique flavor that comes from its mountainous territory pays off to create nothing short of a masterpiece.


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Special financing options help you get what you really want or need
You don't have to let a small budget keep you from getting what you really want or need. That's why Cooling Carolina, LLC offers special financing options.
Our financing can provide you with promotional financing for major purchases, offering you a budget-friendly way to help you get what you really want or need. Expand your purchasing power and convenience with:
- A simple application process, and fast credit decisions
- Unsecured, generous, revolving credit lines
- Open credit line for future purchases
- Convenient monthly payment options
- Competitive interest rates
- No prepayment penalties
And unlike Visa MasterCard and other bank cards, we provide multiple promotional financing options including:
- Deferred interest
- Or fixed payment with interest plans offering APRs and interest rates much lower than most bank card rates


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The page you are looking for is no longer available or has been moved.
- Try these tips:
- If you entered the URL yourself, please make sure that the spelling is correct.
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- Visit our home page to Explore Toshiba
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Gallery Grand - Warlord of Whipped Cream
Nancy's time honored art presented on water-resistant, fade-resistant canvas, printed with eco-solvent, archival ink then hand-stretched over a 2" deep wooden frame. Finished on the back with an artist bio and ready to hang.
Available in 3 standard sizes. 10"x10"x2", 15"x15"x2" or 24"x24".
The smaller sizes look great on tabletops, bookcases and countertops too!
Custom sizes available. Contact us for pricing.
Also available with custom sides. Choose from black/white check, pink/white check, green/white stripes or brown basketweave or choose any color on the print. Enter side choice in notes section of the order form. If no selection is made print will come with sides shown here. Contact us for more information.
Nancy Thomas Gallery products are proudly handcrafted and assembled in the USA.
Click here for care notes for this beautiful piece.


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Canadian Trappers Talk ForumAll content posted is the sole property of the forum member who made the post. Such content shall not be reproduced in anyway without written consent from the individual member who made the post. Any act to do so will be considered copyright infringement.
|It is currently Mon Dec 11, 2023 7:01 pm
View unanswered posts | View active topics
All times are UTC - 4 hours [ DST ]
All times are UTC - 4 hours [ DST ]


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Can't find a dataset and want to make a suggestion? Please click on Suggest a Dataset below and fill out the form description with as much detail as possible. The SEED team will action your request as soon as we can and thank you for your feedback.
Urban Renewal
Repealed SEPP
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Seems adblock is enabled on your browser. We do NOT use pop-up ads and the subtle ad on each page helps keep Lacartes.com completely and permanently free.
In addition, Adblock can sometimes block essential pop-ups that are part of the website's function such as pop-up registration or contact forms.
Please support us by disabling adblock on lacartes.com. We are grateful for your understanding and co-operation!


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The Random Compression Challenge Turns Ten
Ten years ago I issued a simple challenge to the compression community: reduce the size of roughly half a megabyte of random data - by as little as one byte - and be the first to actually have a legitimate claim to this accomplishment.
Ten years later, my challenge is still unmet. After making a small cake and blowing out the candles, I thought this would be a good time to revisit this most venerable quest for coders who think outside the box.
Some History
In George Dyson's great book on the early history of electronic computers, Turing's Cathedral, he describes how much of the impetus for computation in the 40's and 50's was from the US military's urge to design better fission and fusion bombs. A powerful technique used in this design work was the Monte Carlo method, which relied on streams of random numbers to drive simulations.
The problem then, as now, is that coming up with random numbers is not always an easy task. John von Neumann was intimately involved in all this, and is famously quoted as having said:
any one who considers arithmetical methods of producing random digits is, of course, in a state of sin.
The book describes how the RAND corporation, flush with bomb money, took on the task of using physical processes to generate a handy bucket of random numbers, eventually published as A Million Random Digits with 100,000 Normal Deviates.
Since my tax dollars paid for those numbers, I thought it only fair that I make it the basis of my challenge. I took the decimal digits, converted them to a base two number, stored it in AMillionRandomDigits.bin, and challenged the world to compress it. (The original USENET post was followed with a more findable blog posting that contains a bit more detail.)
Ten years later, there have been no serious entrants, although there are a few dedicated souls who are continuing to attack the problem. Unfortunately for all who are working on it, it seems that those RAND scientists back in the 50's did a really, really good job of scrubbing those numbers.
The 2012 Edition
For a few different reasons, it is time to close down the older versions of the contest and issue an updated 2012 challenge. Nothing much has changed, but over the years I've bumped into a few points of confusion that I can clear up, and in addition, I would like to slightly widen the contest's scope. And most importantly, the comments section of the previous contest is way out of hand, and issuing an update lets me close that stream down and open a new one.
For the 2012 edition, I am actually giving entrants two possible ways to win the prize. The first challenge is essentially a reprise of the original, with minor tweaks and updates. The second poses a more difficult problem that is a superset of the first.
Meeting either challenge brings you worldwide fame, a cash prize of $100, and the knowledge that you have defeated a problem that many said was untouchable.
Likewise, both problems are governed by one meta-rule which seeks to implement an overarching principle: the point of this is to win algorithmically, not to game the contest. I will disqualify any entry that wins through means such as hiding data in filenames, environment variables, kernel buffers, or whatever. Someone can always find a way to win with monkey business like this, but that is beside the point of the contest. No hiding data.
Challenge Version 1 - A Kolmogorov Compressor
The original version of the challenge is basically unchanged. Your goal is to find the shortest program possible that will produce the million random digit file. In other words, demonstrate that its Kolmogorov complexity is less than its size. So the heart of Challenge 1 is the question of whether the file is compressible a la Kolmogorov and standard, general purpose computing machines.
The interesting part about this challenge is that it is only very likely impossible. Turing, and Godel before him, made sure that we can't state with any certainty that there is no program of size less than 415,241 bytes that will produce the file. All it takes is a lucky strike. Maybe the digits are a prime? Maybe they just happen to be nested in the expansion of some transcendental number? Or better yet, maybe the RANDians overlooked some redundancy, hidden somewhere in a fifth order curve, just waiting to be fit. There are no telling how many different ways you could hit the jackpot.
However, the dismal logic of The Counting Argument tells us that there are always going to be some files of size 415,241 bytes that are not compressible by the rules of Challenge 1. And of course, it's actually much worse than that - when you cast a critical eye on the task, it turns out that nearly all files are incompressible. But for a given file, we don't really have any way of proving incompressibility.
I want everyone to have the best chance possible to win this challenge. The basic rule is that your program file, possibly combined with a data file, must be less than 415,241 bytes. Clarifications on questions that have come up in the past included:
- Programs written in C or some other compiled language can be measured by the length of their source, not their compiled product.
- Using external programs to strip comments, rename variables, etc. is all fine. It would be nice to have the unmangled source available as your input, with the mangling step part of the submission process.
- Programs that link to standard libraries included with the language don't have to include the length of those libraries against their total. Hiding data in standard libraries is of course not allowed. (And don't even think of hiding it in the kernel!)
- Source code can be submitted in a compressed container of your choice, and I will only count the bytes used by the container against you.
- Likewise, any data files can be submitted in a compressed container, and I will only count the bytes used in the container against you.
- You own the code, and just because you win, I don't have the right to publish it. If you insist on an NDA, I may be willing to comply.
- In general, you need to submit source code that I can build and execute in a relatively standard VM or container. If you are paranoid and insist on binaries only, we might be able to come to terms, but no guarantees.
- The nature of this contest is such that gaming the rules is pointless. You aren't entering in a quest to beat the rules, you are entering in a quest to beat the data.
- Your program might take a long, long time to run, but we will have to draw the line somewhere.
If there is anyone who deserves to beat this file, it is Ernst Berg, who has been relentlessly attacking it from various directions for years now. Ernst doesn't seem to be doing this to feed his ego - he'll share his results with all comers, and is always willing to listen to someone's new approach. I consider him to be the unofficial Sergeant-at-Arms of this enterprise.
But Ernst will also be the first to tell you what a harsh mistress the file can be - always taking, but never giving.
Challenge Version 2 - A General Purpose Random Compressor
Challenge 1 is interesting because it is nearly, but not assuredly impossible. Challenge 2 is more along the lines of troll bait, because it is patently impossible: create a system to compress and then decompress any file of size 415,241 bytes. In other words, create a compressed file that is smaller than the input, then use only that compressed file to restore the original data.
Unlike Challenge 1, there are no size limitations on Challenge 2. Your compressor and decompressor can be as large as you like. Because the programs have to be able to handle any input data, size is of no particular advantage - there is no data to hide.
This challenge is for the contestant who is sure that he or she has figured out a way to compress the million digit file, but finds that their program takes 100 MB of space. Okay, that's fine, we shall first see if it can compress the file. It then must be able to correctly compress and decompress a file of the same size. Let's say, on 1,000 different files.
To keep it simple, the files will be simple permutations of the million digit file - scrambled with an encryption system, or perhaps a random number generator, XORed with a one-time pad, or whatever. The point is, they should have all the same numeric characteristics as the original file, just organized slightly differently.
Again, I will emphasize that Challenge 2 is at its heart provably impossible to beat. No program can compress all files of a given size, and the chances of any program being able to compress 1,000 different files of this length is so vanishingly small that it can safely be ruled out, even if every computer on earth was working on it from now until we are engulfed in flames during Sol's red giant phase.
It seems unlikely that there will be any developments in lossless compression that change the terms of this contest. No doubt I'll reissue the challenge in another ten years or so, but if it is beatable, the tools are already at hand. Good luck to those of you who are tackling the challenge. Beating this will not get you the fame associated with something like the Clay Millenium Prizes, but in the small world of data compression, you will sit alone on a throne of your own making, and deservedly so.
2018 Notes
My WordPress site did not have a good system for handling all the comments on this page. For that and a few other reasons, I am converting all my pages to static pages, which will load much more quickly. In the future, comments will be handled by Disqus, which I think ought to be a better way of doing things.
An archive of the previous 166 pages of comments can be found in this file: Archived Comments.pdf.


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Due to the handmade nature of Jaye Design's production process, measurements will vary slightly. Please do not drill your installation before receiving your hardware order.
Available in all ten finishes. Custom finish quote available upon request.
Installation Photo 1 | Installation Photo 2 | Installation Photo 3
Handmade in the USA
home | about jaye design | products | finishes | installation pictures | rapid ship | where to buy it | price list | press room | catalog | displays
let's get social!
© 2023 Jaye Design LLC • San Francisco, CA
tel: 415.822.4040 • email: email@example.com
All images, logos, trademarks, etc. contained in this website are property of Jaye Design LLC and may not be used without
explicit permission granted by Jaye Design LLC. Permission must be obtained in writing for each specific use.
Permission granted is not transferable to a third party or to be interpreted as being granted for any additional uses.


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Art Deco Cherry Seat Pad Cover
From the Arts & Crafts collection by iLiv
4.9 / 5
Please use our free post sample service
Images are designed to be a representation of how your customised product will look. The scale, size and colour may vary.
Our Price: ...
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Choose 'No Rush Delivery' at the checkout to save £ off your order.
Pay in installments with Klarna. No fees. Learn more
- Made to measure in the UK
- Brand: iLiv
- Product Code: BI00016-SPC
- Availability: Available
- Product Type: Seat Pad Cover
Need Help?
Chat to us online for help and advice on your made to measure items.
Art Deco Cherry is part of our British made to measure Seat Pad Covers range. Art Deco Cherry is made from 100% Cotton and designed by iLiv. This inspirational fabric design is a perfect match for all interiors. Made to measure with a range of different options and extras your custom made Art Deco Cherry Seat Pad Coverswill bring individuality back into your home.
|Art Deco Cherry - Fabric
|Arts & Crafts
|100% Cotton
|Fabric Width (cm)
|Pattern Repeat (cm)
|Price (per metre)
Tags: iLiv, Red, Floral, 100% Cotton
Highest Quality Fabrics
Our fabrics are sourced from the top fabric suppliers within the UK, every fabric is meticulously checked before it goes into production with absolutely no compromise on quality, we always strive for perfection.
A Complete Look
We offer many made to measure items to complete the look of your room, including door stops, table cloths, valances, pelmets and much more.
Made In The UK
Every made to measure item we provide is made in-house here in the UK. This ensures that our high standards of quality are met every time.
Guaranteed Unbeatable Prices
There is absolutely no compromise on quality. Our mission is to transform every one of our customer's homes into a place they are excited about and proud to be at. We are determined to do this at the most affordable prices possible anywhere in the UK, if you can find a product cheaper elsewhere let us know and we will beat the price.
Order a Fabric Sample
Art Deco Cherry
by iLiv
Would you like a sample of this fabric?
Order a sample of Art Deco Cherry by iLiv from just £1.30.
How soon can I get my Seat Pad Cover?
Standard Mainland UK
Made to measure in 25 working days
Priority Ordering
Made to measure in 14 working days


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Home & Garden Pesticides Market research report is the new statistical data source added by A2Z Market Research.
"Home & Garden Pesticides Market is growing at a High CAGR during the forecast period 2021-2027. The increasing interest of the individuals in this industry is that the major reason for the expansion of this market".
Home & Garden Pesticides Market research is an intelligence report with meticulous efforts undertaken to study the right and valuable information. The data which has been looked upon is done considering both, the existing top players and the upcoming competitors. Business strategies of the key players and the new entering market industries are studied in detail. Well explained SWOT analysis, revenue share and contact information are shared in this report analysis.
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Note – In order to provide more accurate market forecast, all our reports will be updated before delivery by considering the impact of COVID-19.
Top Key Players Profiled in this report are:
Bayer (Bayer Advanced), Bonide Products, Central Garden & Pet, Espoma.
The key questions answered in this report:
- What will be the Market Size and Growth Rate in the forecast year?
- What are the Key Factors driving Home & Garden Pesticides Market?
- What are the Risks and Challenges in front of the market?
- Who are the Key Vendors in Home & Garden Pesticides Market?
- What are the Trending Factors influencing the market shares?
- What are the Key Outcomes of Porter's five forces model?
- Which are the Global Opportunities for Expanding the Home & Garden Pesticides Market?
Various factors are responsible for the market's growth trajectory, which are studied at length in the report. In addition, the report lists down the restraints that are posing threat to the global Home & Garden Pesticides market. It also gauges the bargaining power of suppliers and buyers, threat from new entrants and product substitute, and the degree of competition prevailing in the market. The influence of the latest government guidelines is also analyzed in detail in the report. It studies the Home & Garden Pesticides market's trajectory between forecast periods.
Global Home & Garden Pesticides Market Segmentation:
Market Segmentation: By Type
* Insecticides
* Herbicides
* Fungicides
* Other Pesticides
Market Segmentation: By Application
* Household
* Commercial
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Regions Covered in the Global Home & Garden Pesticides Market Report 2021:
• The Middle East and Africa (GCC Countries and Egypt)
• North America (the United States, Mexico, and Canada)
• South America (Brazil etc.)
• Europe (Turkey, Germany, Russia UK, Italy, France, etc.)
• Asia-Pacific (Vietnam, China, Malaysia, Japan, Philippines, Korea, Thailand, India, Indonesia, and Australia)
The cost analysis of the Global Home & Garden Pesticides Market has been performed while keeping in view manufacturing expenses, labor cost, and raw materials and their market concentration rate, suppliers, and price trend. Other factors such as Supply chain, downstream buyers, and sourcing strategy have been assessed to provide a complete and in-depth view of the market. Buyers of the report will also be exposed to a study on market positioning with factors such as target client, brand strategy, and price strategy taken into consideration.
The report provides insights on the following pointers:
Market Penetration: Comprehensive information on the product portfolios of the top players in the Home & Garden Pesticides market.
Product Development/Innovation: Detailed insights on the upcoming technologies, R&D activities, and product launches in the market.
Competitive Assessment: In-depth assessment of the market strategies, geographic and business segments of the leading players in the market.
Market Development: Comprehensive information about emerging markets. This report analyzes the market for various segments across geographies.
Market Diversification: Exhaustive information about new products, untapped geographies, recent developments, and investments in the Home & Garden Pesticides market.
Table of Contents
Global Home & Garden Pesticides Market Research Report 2021 – 2027
Chapter 1 Home & Garden Pesticides Market Overview
Chapter 2 Global Economic Impact on Industry
Chapter 3 Global Market Competition by Manufacturers
Chapter 4 Global Production, Revenue (Value) by Region
Chapter 5 Global Supply (Production), Consumption, Export, Import by Regions
Chapter 6 Global Production, Revenue (Value), Price Trend by Type
Chapter 7 Global Market Analysis by Application
Chapter 8 Manufacturing Cost Analysis
Chapter 9 Industrial Chain, Sourcing Strategy and Downstream Buyers
Chapter 10 Marketing Strategy Analysis, Distributors/Traders
Chapter 11 Market Effect Factors Analysis
Chapter 12 Global Home & Garden Pesticides Market Forecast
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Label: BUSPIRONE HYDROCHLORIDE tablet
- NDC Code(s): 71610-608-60
- Packager: Aphena Pharma Solutions - Tennessee, LLC
- This is a repackaged label.
- Source NDC Code(s): 51407-414
- Category: HUMAN PRESCRIPTION DRUG LABEL
- DEA Schedule: None
- Marketing Status: Abbreviated New Drug Application
Drug Label Information
Updated November 8, 2021
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
Buspirone hydrochloride is an antianxiety agent that is not chemically or pharmacologically related to the benzodiazepines, barbiturates, or other sedative/anxiolytic drugs.
Buspirone hydrochloride is a white crystalline, water soluble compound with a molecular weight of 422.0. Chemically, buspirone hydrochloride is 8-[4-[4-(2-pyrimidinyl)-1-piperazinyl]butyl]-8-azaspiro[4,5]decane-7,9-dione monohydrochloride. The empirical formula C21H31N5O2.HCl is represented by the following structural formula:
Buspirone hydrochloride tablets, USP for oral administration, contains 5 mg, 7.5 mg, 10 mg, 15 mg or 30 mg of buspirone hydrochloride, USP (equivalent to 4.6 mg, 6.9 mg, 9.1 mg, 13.7 mg and 27.4 mg of buspirone free base respectively). The 5 mg and 10 mg tablets are scored so they can be bisected. Thus, the 5 mg tablet can also provide a 2.5 mg dose, and the 10 mg tablet can provide a 5 mg dose. The 15 mg tablets are scored such that they may be bisected or trisected. Thus, a single 15 mg tablet can provide the following doses: 15 mg (entire tablet), 10 mg (two thirds of a tablet), 7.5 mg (one-half of a tablet), or 5 mg (one-third of a tablet). The 30 mg tablets are scored such that they may be bisected or trisected. A single 30 mg tablet can provide the following doses: 30 mg (entire tablet), 20 mg (two-thirds of a tablet), 15 mg (one-half of a tablet), or 10 mg (one-third of a tablet). Buspirone hydrochloride tablets, USP contain the following inactive ingredients: colloidal silicon dioxide, lactose monohydrate, magnesium stearate, microcrystalline cellulose, and sodium starch glycolate.
The mechanism of action of buspirone is unknown. Buspirone differs from typical benzodiazepine anxiolytics in that it does not exert anticonvulsant or muscle relaxant effects. It also lacks the prominent sedative effect that is associated with more typical anxiolytics. In vitro preclinical studies have shown that buspirone has a high affinity for serotonin (5-HT 1A) receptors. Buspirone has no significant affinity for benzodiazepine receptors and does not affect GABA binding in vitro or in vivo when tested in preclinical models.
Buspirone has moderate affinity for brain D 2-dopamine receptors. Some studies do suggest that buspirone may have indirect effects on other neurotransmitter systems.
Buspirone is rapidly absorbed in man and undergoes extensive first-pass metabolism. In a radiolabeled study, unchanged buspirone in the plasma accounted for only about 1% of the radioactivity in the plasma. Following oral administration, plasma concentrations of unchanged buspirone are very low and variable between subjects. Peak plasma levels of 1 ng/mL to 6 ng/mL have been observed 40 to 90 minutes after single oral doses of 20 mg. The single-dose bioavailability of unchanged buspirone when taken as a tablet is on the average about 90% of an equivalent dose of solution, but there is large variability.
The effects of food upon the bioavailability of buspirone have been studied in eight subjects. They were given a 20 mg dose with and without food; the area under the plasma concentration-time curve (AUC) and peak plasma concentration (C max) of unchanged buspirone increased by 84% and 116% respectively, but the total amount of buspirone immunoreactive material did not change. This suggests that food may decrease the extent of presystemic clearance of buspirone (see DOSAGE AND ADMINISTRATION).
A multiple-dose study conducted in 15 subjects suggests that buspirone has nonlinear pharmacokinetics. Thus, dose increases and repeated dosing may lead to somewhat higher blood levels of unchanged buspirone than would be predicted from results of single-dose studies.
An in vitro protein binding study indicated that approximately 86% of buspirone is bound to plasma proteins. It was also observed that aspirin increased the plasma levels of free buspirone by 23%, while flurazepam decreased the plasma levels of free buspirone by 20%. However, it is not known whether these drugs cause similar effects on plasma levels of free buspirone in vivo, or whether such changes, if they do occur, cause clinically significant differences in treatment outcome. An in vitro study indicated that buspirone did not displace highly protein-bound drugs such as phenytoin, warfarin, and propranolol from plasma protein, and that buspirone may displace digoxin.
Buspirone is metabolized primarily by oxidation, which in vitro has been shown to be mediated by cytochrome P450 3A4 (CYP3A4) (see PRECAUTIONS, Drug Interactions). Several hydroxylated derivatives and a pharmacologically active metabolite, 1-pyrimidinylpiperazine (1-PP), are produced. In animal models predictive of anxiolytic potential, 1-PP has about one quarter of the activity of buspirone, but is present in up to 20 fold greater amounts. However, this is probably not important in humans: blood samples from humans chronically exposed to buspirone hydrochloride do not exhibit high levels of 1-PP; mean values are approximately 3 ng/mL and the highest human blood level recorded among 108 chronically dosed patients was 17 ng/mL, less than 1/200th of 1-PP levels found in animals given large doses of buspirone without signs of toxicity.
In a single-dose study using 14C-labeled buspirone, 29% to 63% of the dose was excreted in the urine within 24 hours, primarily as metabolites; fecal excretion accounted for 18% to 38% of the dose. The average elimination half-life of unchanged buspirone after single doses of 10 to 40 mg is about 2 to 3 hours.
Special Populations
After single or multiple doses in adults, no significant differences in buspirone pharmacokinetics (AUC and Cmax) were observed between elderly and younger subjects or between men and women.
Hepatic Impairment
After multiple-dose administration of buspirone to patients with hepatic impairment, steady-state AUC of buspirone increased 13 fold compared with healthy subjects (see PRECAUTIONS).
Renal Impairment
After multiple-dose administration of buspirone to renally impaired (Clcr = 10 - 70 mL/min/1.73 m 2) patients, steady-state AUC of buspirone increased 4 fold compared with healthy (Clcr ≥ 80 mL/min/1.73 m2) subjects (see PRECAUTIONS).
Race Effects
The effects of race on the pharmacokinetics of buspirone have not been studied.
Buspirone hydrochloride tablets are indicated for the management of anxiety disorders or the short-term relief of the symptoms of anxiety. Anxiety or tension associated with the stress of everyday life usually does not require treatment with an anxiolytic.
The efficacy of buspirone has been demonstrated in controlled clinical trials of outpatients whose diagnosis roughly corresponds to Generalized Anxiety Disorder (GAD). Many of the patients enrolled in these studies also had coexisting depressive symptoms and buspirone relieved anxiety in the presence of these coexisting depressive symptoms. The patients evaluated in these studies had experienced symptoms for periods of 1 month to over 1 year prior to the study, with an average symptom duration of 6 months. Generalized Anxiety Disorder (300.02) is described in the American Psychiatric Association's Diagnostic and Statistical Manual, III 1 as follows:
Generalized, persistent anxiety (of at least 1 month continual duration), manifested by symptoms from three of the four following categories:
- Motor tension: shakiness, jitteriness, jumpiness, trembling, tension, muscle aches, fatigability, inability to relax, eyelid twitch, furrowed brow, strained face, fidgeting, restlessness, easy startle.
- Autonomic hyperactivity: sweating, heart pounding or racing, cold, clammy hands, dry mouth, dizziness, lightheadedness, paresthesias (tingling in hands or feet), upset stomach, hot or cold spells, frequent urination, diarrhea, discomfort in the pit of the stomach, lump in the throat, flushing, pallor, high resting pulse and respiration rate.
- Apprehensive expectation: anxiety, worry, fear, rumination, and anticipation of misfortune to self or others.
- Vigilance and scanning: hyperattentiveness resulting in distractibility, difficulty in concentrating, insomnia, feeling "on edge", irritability, impatience.
The above symptoms would not be due to another mental disorder, such as a depressive disorder or schizophrenia. However, mild depressive symptoms are common in GAD.
The effectiveness of buspirone in long-term use, that is, for more than 3 to 4 weeks, has not been demonstrated in controlled trials. There is no body of evidence available that systematically addresses the appropriate duration of treatment for GAD. However, in a study of long-term use, 264 patients were treated with buspirone for 1 year without ill effect. Therefore, the physician who elects to use buspirone for extended periods should periodically reassess the usefulness of the drug for the individual patient.
Buspirone hydrochloride tablets are contraindicated in patients hypersensitive to buspirone hydrochloride.
The use of monoamine oxidase inhibitors (MAOIs) intended to treat depression with buspirone or within 14 days of stopping treatment with buspirone is contraindicated because of an increased risk of serotonin syndrome and/or elevated blood pressure. The use of buspirone within 14 days of stopping an MAOI intended to treat depression is also contraindicated.
Starting buspirone in a patient who is being treated with reversible MAOIs such as linezolid or intravenous methylene blue is also contraindicated because of an increased risk of serotonin syndrome. (see WARNINGS, DOSAGE AND ADMINISTRATION AND DRUG INTERACTIONS)
The administration of buspirone to a patient taking a monoamine oxidase inhibitor (MAOI) may pose a hazard. There have been reports of the occurrence of elevated blood pressure when buspirone hydrochloride has been added to a regimen including an MAOI. Therefore, it is recommended that buspirone not be used concomitantly with an MAOI.
Serotonin Syndrome
The development of a potentially life threatening serotonin syndrome has been reported with SNRIs SSRIs, and other serotonergic drugs, including buspirone, alone but particularly with concomitant use of other serotonergic drugs (including triptans), with drugs that impair metabolism of serotonin (in particular, MAOIs, including reversible MAOIs such as linezolid and intravenous methylene blue), or with antipsychotics or other dopamine antagonists.
Serotonin syndrome symptoms may include mental status changes (e.g., agitation, hallucinations, delirium, and coma), autonomic instability (e.g., tachycardia, labile blood pressure, dizziness, diaphoresis, flushing, hyperthermia), neuromuscular changes (e.g., tremor, rigidity, myoclonus, hyperreflexia, incoordination), seizures, and/or gastrointestinal symptoms (e.g., nausea, vomiting, diarrhea).Patients should be monitored for emergence of serotonin syndrome.
The concomitant use of buspirone with MAOIs intended to treat depression is contraindicated. Buspirone should also not be started in a patient who is being treated with reversible MAOIs such as linezolid or intravenous methylene blue. All reports with methylene blue that provided information on the route of administration involved intravenous administration in the dose range of 1 mg/kg to 8 mg/kg. There have been no reports involving the administration of methylene blue by other routes (such as oral tablets or local tissue injection) or at lower doses. There may be circumstances when it is necessary to initiate treatment with a reversible MAOI such as linezolid or intravenous methylene blue in a patient taking buspirone. Buspirone should be discontinued before initiating treatment with the reversible MAOI [see CONTRAINDICATIONS, DOSAGE AND ADMINISTRATION AND DRUG INTERACTIONS].
If concomitant use of buspirone with a 5-hydroxytryptmine receptor agonist (triptan) is clinically warranted, careful observation of the patient is advised, particularly during treatment initiation and dose increases.
The concomitant use of buspirone with serotonin precursors (such as tryptophan) is not recommended.
Treatment with buspirone and any concomitant serotonergic or antidopaminergic agents, including antipsychotics, should be discontinued immediately if the above events occur and supportive symptomatic treatment should be initiated.
Because buspirone hydrochloride tablets have no established antipsychotic activity, it should not be employed in lieu of appropriate antipsychotic treatment.
Interference with Cognitive and Motor Performance
Studies indicate that buspirone is less sedating than other anxiolytics and that it does not produce significant functional impairment. However, its CNS effects in any individual patient may not be predictable. Therefore, patients should be cautioned about operating an automobile or using complex machinery until they are reasonably certain that buspirone treatment does not affect them adversely.
While formal studies of the interaction of buspirone hydrochloride with alcohol indicate that buspirone does not increase alcohol-induced impairment in motor and mental performance, it is prudent to avoid concomitant use of alcohol and buspirone.
Potential for Withdrawal Reactions in Sedative/Hypnotic/Anxiolytic Drug-Dependent Patients
Because buspirone does not exhibit cross-tolerance with benzodiazepines and other common sedative/hypnotic drugs, it will not block the withdrawal syndrome often seen with cessation of therapy with these drugs. Therefore, before starting therapy with buspirone, it is advisable to withdraw patients gradually, especially patients who have been using a CNS-depressant drug chronically, from their prior treatment. Rebound or withdrawal symptoms may occur over varying time periods, depending in part on the type of drug, and its effective half-life of elimination.
The syndrome of withdrawal from sedative/hypnotic/anxiolytic drugs can appear as any combination of irritability, anxiety, agitation, insomnia, tremor, abdominal cramps, muscle cramps, vomiting, sweating, flu-like symptoms without fever, and occasionally, even as seizures.
Possible Concerns Related to Buspirone's Binding to Dopamine Receptors
Because buspirone can bind to central dopamine receptors, a question has been raised about its potential to cause acute and chronic changes in dopamine-mediated neurological function (e.g., dystonia, pseudo-parkinsonism, akathisia, and tardive dyskinesia). Clinical experience in controlled trials has failed to identify any significant neuroleptic-like activity; however, a syndrome of restlessness, appearing shortly after initiation of treatment, has been reported in some small fraction of buspirone-treated patients. The syndrome may be explained in several ways. For example, buspirone may increase central noradrenergic activity; alternatively, the effect may be attributable to dopaminergic effects (i.e., represent akathisia). See ADVERSE REACTIONS, Postmarketing Experience.
Information for Patients
To assure safe and effective use of Buspirone hydrochloride tablets, the following information and instructions should be given to patients:
- Do not take a monoamine oxidase inhibitor (MAOI). Ask your healthcare provider or pharmacist if you are not sure if you take an MAOI, including the antibiotic linezolid.
- Do not take an MAOI within 2 weeks of stopping buspirone unless directed to do so by your physician
- Do not start buspirone if you stopped taking an MAOI in the last 2 weeks unless directed to do so by your physician.
- Inform your physician about any medications, prescription or non-prescription, alcohol, or drugs that you are now taking or plan to take during your treatment with buspirone.
- Inform your physician if you are pregnant, or if you are planning to become pregnant, or if you become pregnant while you are taking buspirone.
- Inform your physician if you are breast-feeding an infant.
- Until you experience how this medication affects you, do not drive a car or operate potentially dangerous machinery.
- You should take buspirone consistently, either always with or always without food.
- During your treatment with buspirone, avoid drinking large amounts of grapefruit juice.
Drug Interactions
MAO inhibitors: The use of monoamine oxidase inhibitors (MAOIs) intended to treat depression with buspirone or within 14 days of stopping treatment with buspirone is contraindicated because of an increased risk of serotonin syndrome and/or elevated blood pressure. The use of buspirone within 14 days of stopping an MAOI intended to treat depression is also contraindicated.
Starting buspirone in a patient who is being treated with reversible MAOIs such as linezolid or intravenous methylene blue is also contraindicated because of an increased risk of serotonin syndrome. (see WARNINGS, DOSAGE AND ADMINISTRATION AND CONCOMITANT DRUG)
Amitriptyline: After addition of buspirone to the amitriptyline dose regimen, no statistically significant differences in the steady-state pharmacokinetic parameters (Cmax, AUC, and Cmin) of amitriptyline or its metabolite nortriptyline were observed.
Diazepam: After addition of buspirone to the diazepam dose regimen, no statistically significant differences in the steady-state pharmacokinetic parameters (Cmax, AUC, and Cmin) were observed for diazepam, but increases of about 15% were seen for nordiazepam, and minor adverse clinical effects (dizziness, headache, and nausea) were observed.
Haloperidol: In a study in normal volunteers, concomitant administration of buspirone and haloperidol resulted in increased serum haloperidol concentrations. The clinical significance of this finding is not clear.
Nefazodone: (see Inhibitors and Inducers of Cytochrome P450 3A4 [CYP3A4])
Trazodone: There is one report suggesting that the concomitant use of trazodone hydrochloride and buspirone may have caused 3 to 6 fold elevations on SGPT (ALT) in a few patients. In a similar study attempting to replicate this finding, no interactive effect on hepatic transaminases was identified.
Triazolam/Flurazepam: Coadministration of buspirone with either triazolam or flurazepam did not appear to prolong or intensify the sedative effects of either benzodiazepine.
Other Psychotropics: Because the effects of concomitant administration of buspirone with most other psychotropic drugs have not been studied, the concomitant use of buspirone with other CNS-active drugs should be approached with caution.
Inhibitors and Inducers of Cytochrome P450 3A4 [CYP3A4]
Buspirone has been shown in vitro to be metabolized by CYP3A4. This finding is consistent with the in vivo interactions observed between buspirone and the following:
Diltiazem and Verapamil: In a study of nine healthy volunteers, coadministration of buspirone (10 mg as a single dose) with verapamil (80 mg t.i.d.) or diltiazem (60 mg t.i.d.) increased plasma buspirone concentrations (verapamil increased AUC and Cmax of buspirone 3.4 fold while diltiazem increased AUC and Cmax 5.5 fold and 4 fold, respectively). Adverse events attributable to buspirone may be more likely during concomitant administration with either diltiazem or verapamil. Subsequent dose adjustment may be necessary and should be based on clinical assessment.
Erythromycin: In a study in healthy volunteers, coadministration of buspirone (10 mg as a single dose) with erythromycin (1.5 g/day for 4 days) increased plasma buspirone concentrations (5 fold increase in Cmax and 6 fold increase in AUC). These pharmacokinetic interactions were accompanied by an increased incidence of side effects attributable to buspirone. If the two drugs are to be used in combination, a low dose of buspirone (e.g., 2.5 mg b.i.d.) is recommended. Subsequent dose adjustment of either drug should be based on clinical assessment.
Grapefruit juice: In a study in healthy volunteers, coadministration of buspirone (10 mg as a single dose) with grapefruit juice (200 mL double-strength t.i.d. for 2 days) increased plasma buspirone concentrations (4.3 fold increase in Cmax; 9.2 fold increase in AUC). Patients receiving buspirone should be advised to avoid drinking such large amounts of grapefruit juice.
Itraconazole: In a study in healthy volunteers, coadministration of buspirone (10 mg as a single dose) with itraconazole (200 mg/day for 4 days) increased plasma buspirone concentrations (13 fold increase in Cmax and 19 fold increase in AUC). These pharmacokinetic interactions were accompanied by an increased incidence of side effects attributable to buspirone. If the two drugs are to be used in combination, a low dose of buspirone (e.g., 2.5 mg q.d.) is recommended. Subsequent dose adjustment of either drug should be based on clinical assessment.
Nefazodone: In a study of steady-state pharmacokinetics in healthy volunteers, coadministration of buspirone (2.5 or 5 mg b.i.d.) with nefazodone (250 mg b.i.d.) resulted in marked increases in plasma buspirone concentrations (increases up to 20 fold in Cmax and up to 50 fold in AUC) and statistically significant decreases (about 50%) in plasma concentrations of the buspirone metabolite 1-PP. With 5 mg b.i.d. doses of buspirone, slight increases in AUC were observed for nefazodone (23%) and its metabolites hydroxynefazodone (HO-NEF) (17%) and metachlorophenylpiperazine (9%). Slight increases in Cmax were observed for nefazodone (8%) and its metabolite HO-NEF (11%). Subjects receiving buspirone 5 mg b.i.d. and nefazodone 250 mg b.i.d experienced lightheadedness, asthenia, dizziness, and somnolence, adverse events also observed with either drug alone. If the two drugs are to be used in combination, a low dose of buspirone (e.g., 2.5 mg q.d.) is recommended. Subsequent dose adjustment of either drug should be based on clinical assessment.
Rifampin: In a study in healthy volunteers, coadministration of buspirone (30 mg as a single dose) with rifampin (600 mg/day for 5 days) decreased the plasma concentrations (83.7% decrease in Cmax; 89.6% decrease in AUC) and pharmacodynamic effects of buspirone. If the two drugs are to be used in combination, the dosage of buspirone may need adjusting to maintain anxiolytic effect.
Other inhibitors and inducers of CYP3A4: Substances that inhibit CYP3A4, such as ketoconazole or ritonavir, may inhibit buspirone metabolism and increase plasma concentrations of buspirone while substances that induce CYP3A4, such as dexamethasone, or certain anticonvulsants (phenytoin, phenobarbital, carbamazepine), may increase the rate of buspirone metabolism. If a patient has been titrated to a stable dosage on buspirone, a dose adjustment of buspirone may be necessary to avoid adverse events attributable to buspirone or diminished anxiolytic activity. Consequently, when administered with a potent inhibitor of CYP3A4, a low dose of buspirone used cautiously is recommended. When used in combination with a potent inducer of CYP3A4 the dosage of buspirone may need adjusting to maintain anxiolytic effect.
Other Drugs
Cimetidine: Coadministration of buspirone with cimetidine was found to increase Cmax (40%) and Tmax (2 fold), but had minimal effects on the AUC of buspirone.
Protein Binding
In vitro, buspirone does not displace tightly bound drugs like phenytoin, propanolol, and warfarin from serum proteins. However, there has been one report of prolonged prothrombin time when buspirone was added to the regimen of a patient treated with warfarin. The patient was also chronically receiving phenytoin, phenobarbital, digoxin, and levothyroxine sodium. In vitro, buspirone may displace less firmly bound drugs like digoxin. The clinical significance of this property is unknown.
Therapeutic levels of aspirin, desipramine, diazepam, flurazepam, ibuprofen, propranolol, thioridazine, and tolbutamide had only a limited effect on the extent of binding of buspirone to plasma proteins (see CLINICAL PHARMACOLOGY).
Drug/Laboratory Test Interactions
Buspirone is not known to interfere with the urinary metanephrine/catecholamine assay. It has been mistakenly read as metanephrine during routine assay testing for pheochromocytoma, resulting in a false positive laboratory result. Buspirone hydrochloride should therefore be discontinued for at least 48 hours prior to undergoing a urine collection for catecholamines.
Carcinogenesis, Mutagenesis, Impairment of Fertility
No evidence of carcinogenic potential was observed in rats during a 24-month study at approximately 133 times the maximum recommended human oral dose; or in mice, during an 18-month study at approximately 167 times the maximum recommended human oral dose.
With or without metabolic activation, buspirone did not induce point mutations in five strains of Salmonella typhimurium (Ames Test) or mouse lymphoma L5178YTK+ cell cultures, nor was DNA damage observed with buspirone in Wi-38 human cells. Chromosomal aberrations or abnormalities did not occur in bone marrow cells of mice given one or five daily doses of buspirone.
Pregnancy: Teratogenic Effects
Pregnancy category B: No fertility impairment or fetal damage was observed in reproduction studies performed in rats and rabbits at buspirone doses of approximately 30 times the maximum recommended human dose. In humans, however, adequate and well-controlled studies during pregnancy have not been performed. Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed.
Labor and Delivery
The effect of buspirone on labor and delivery in women is unknown. No adverse effects were noted in reproduction studies in rats.
Nursing Mothers
The extent of the excretion in human milk of buspirone or its metabolites is not known. In rats, however, buspirone and its metabolites are excreted in milk. Buspirone administration to nursing women should be avoided if clinically possible.
Pediatric Use
The safety and effectiveness of buspirone were evaluated in two placebo-controlled 6 week trials involving a total of 559 pediatric patients (ranging from 6 to 17 years of age) with GAD. Doses studied were 7.5 mg to 30 mg b.i.d. (15 to 60 mg/day). There were no significant differences between buspirone and placebo with regard to the symptoms of GAD following doses recommended for the treatment of GAD in adults. Pharmacokinetic studies have shown that, for identical doses, plasma exposure to buspirone and its active metabolite, 1-PP, are equal to or higher in pediatric patients than adults. No unexpected safety findings were associated with buspirone in these trials. There are no long-term safety or efficacy data in this population.
Geriatric Use
In one study of 6632 patients who received buspirone for the treatment of anxiety, 605 patients were ≥ 65 years old and 41 were ≥ 75 years old; the safety and efficacy profiles for these 605 elderly patients (mean age = 70.8 years) were similar to those in the younger population (mean age = 43.3 years). Review of spontaneously reported adverse clinical events has not identified differences between elderly and younger patients, but greater sensitivity of some older patients can not be ruled out.
There were no effects of age on the pharmacokinetics of buspirone (see CLINICAL PHARMACOLOGY, Special Populations).
Use in Patients With Impaired Hepatic or Renal Function
Buspirone is metabolized by the liver and excreted by the kidneys. A pharmacokinetic study in patients with impaired hepatic or renal function demonstrated increased plasma levels and a lengthened half-life of buspirone. Therefore, the administration of Buspirone Hydrochloride Tablets, USP to patients with severe hepatic or renal impairment cannot be recommended (see CLINICAL PHARMACOLOGY).
Commonly Observed
The more commonly observed untoward events associated with the use of buspirone not seen at an equivalent incidence among placebo-treated patients include dizziness, nausea, headache, nervousness, lightheadedness, and excitement.
Associated With Discontinuation of Treatment
One guide to the relative clinical importance of adverse events associated with buspirone is provided by the frequency with which they caused drug discontinuation during clinical testing. Approximately 10% of the 2200 anxious patients who participated in the buspirone premarketing clinical efficacy trials in anxiety disorders lasting 3 to 4 weeks discontinued treatment due to an adverse event. The more common events causing discontinuation included: central nervous system disturbances (3.4%), primarily dizziness, insomnia, nervousness, drowsiness, and lightheaded feeling; gastrointestinal disturbances (1.2%), primarily nausea; and miscellaneous disturbances (1.1%), primarily headache and fatigue. In addition, 3.4% of patients had multiple complaints, none of which could be characterized as primary.
Incidence in Controlled Clinical Trials
The table that follows enumerates adverse events that occurred at a frequency of 1% or more among buspirone hydrochloride patients who participated in 4 week, controlled trials comparing buspirone with placebo. The frequencies were obtained from pooled data for 17 trials. The prescriber should be aware that these figures cannot be used to predict the incidence of side effects in the course of usual medical practice where patient characteristics and other factors differ from those which prevailed in the clinical trials. Similarly, the cited frequencies cannot be compared with figures obtained from other clinical investigations involving different treatments, uses, and investigators. Comparison of the cited figures, however, does provide the prescribing physician with some basis for estimating the relative contribution of drug and nondrug factors to the side-effect incidence rate in the population studied.
(Percent of Patients Reporting)
*Events reported by at least 1% of buspirone patients are included.
- Incidence less than 1%.
Adverse Experience
(n = 477)
(n = 464)
Decreased Concentration
Blurred Vision
Dry Mouth
Abdominal/Gastric Distress
Musculoskeletal Aches/Pains
Skin Rash
Other Events Observed During the Entire Premarketing Evaluation of Buspirone
During its premarketing assessment, buspirone was evaluated in over 3500 subjects. This section reports event frequencies for adverse events occurring in approximately 3000 subjects from this group who took multiple doses of buspirone in the dose range for which buspirone is being recommended (i.e., the modal daily dose of buspirone fell between 10 and 30 mg for 70% of the patients studied) and for whom safety data were systematically collected. The conditions and duration of exposure to buspirone varied greatly, involving well-controlled studies as well as experience in open and uncontrolled clinical settings. As part of the total experience gained in clinical studies, various adverse events were reported. In the absence of appropriate controls in some of the studies, a causal relationship to buspirone hydrochloride treatment cannot be determined. The list includes all undesirable events reasonably associated with the use of the drug.
The following enumeration by organ system describes events in terms of their relative frequency of reporting in this data base. Events of major clinical importance are also described in the PRECAUTIONS section.
The following definitions of frequency are used: Frequent adverse events are defined as those occurring in at least 1/100 patients. Infrequent adverse events are those occurring in 1/100 to 1/1000 patients, while rare events are those occurring in less than 1/1000 patients.
Frequent was nonspecific chest pain; infrequent were syncope, hypotension, and hypertension; rare were cerebrovascular accident, congestive heart failure, myocardial infarction, cardiomyopathy, and bradycardia.
Central Nervous System
Frequent were dream disturbances; infrequent were depersonalization, dysphoria, noise intolerance, euphoria, akathisia, fearfulness, loss of interest, dissociative reaction, hallucinations, involuntary movements, slowed reaction time, suicidal ideation, and seizures; rare were feelings of claustrophobia, cold intolerance, stupor, and slurred speech and psychosis.
Frequent were tinnitus, sore throat, and nasal congestion; infrequent were redness and itching of the eyes, altered taste, altered smell, and conjunctivitis; rare were inner ear abnormality, eye pain, photophobia, and pressure on eyes.
Infrequent were flatulence, anorexia, increased appetite, salivation, irritable colon, and rectal bleeding; rare was burning of the tongue.
Infrequent were urinary frequency, urinary hesitancy, menstrual irregularity and spotting, and dysuria; rare were amenorrhea, pelvic inflammatory disease, enuresis, and nocturia.
Infrequent were muscle cramps, muscle spasms, rigid/stiff muscles, and arthralgias; rare was muscle weakness.
Infrequent were hyperventilation, shortness of breath, and chest congestion; rare was epistaxis.
Sexual Function
Infrequent were decreased or increased libido; rare were delayed ejaculation and impotence.
Infrequent were edema, pruritus, flushing, easy bruising, hair loss, dry skin, facial edema, and blisters; rare were acne and thinning of nails.
Clinical Laboratory
Infrequent were increases in hepatic aminotransferases (SGOT, SGPT); rare were eosinophilia, leukopenia, and thrombocytopenia.
Postmarketing Experience
Postmarketing experience has shown an adverse experience profile similar to that given above. Voluntary reports since introduction have included rare occurrences of allergic reactions (including urticaria), angioedema, cogwheel rigidity, dizziness (rarely reported as vertigo), dystonic reactions (including dystonia), ataxias, extrapyramidal symptoms, dyskinesias (acute and tardive), ecchymosis, emotional lability, serotonin syndrome, transient difficulty with recall, urinary retention, visual changes (including tunnel vision), parkinsonism, akathisia, restless leg syndrome, and restlessness. Because of the uncontrolled nature of these spontaneous reports, a causal relationship to buspirone treatment has not been determined.
Physical and Psychological Dependence
In human and animal studies, buspirone has shown no potential for abuse or diversion and there is no evidence that it causes tolerance, or either physical or psychological dependence. Human volunteers with a history of recreational drug or alcohol usage were studied in two double-blind clinical investigations. None of the subjects were able to distinguish between buspirone and placebo. By contrast, subjects showed a statistically significant preference for methaqualone and diazepam. Studies in monkeys, mice, and rats have indicated that buspirone lacks potential for abuse.
Following chronic administration in the rat, abrupt withdrawal of buspirone did not result in the loss of body weight commonly observed with substances that cause physical dependency.
Although there is no direct evidence that buspirone causes physical dependence or drug-seeking behavior, it is difficult to predict from experiments the extent to which a CNS-active drug will be misused, diverted, and/or abused once marketed. Consequently, physicians should carefully evaluate patients for a history of drug abuse and follow such patients closely, observing them for signs of buspirone misuse or abuse (e.g., development of tolerance, incrementation of dose, drug-seeking behavior).
Call your doctor for medical advice about side effects. You may report side effects to Strides Pharma Inc. at 1-877-244-9825 or go to www.strides.com.
Signs and Symptoms
In clinical pharmacology trials, doses as high as 375 mg/day were administered to healthy male volunteers. As this dose was approached, the following symptoms were observed: nausea, vomiting, dizziness, drowsiness, miosis, and gastric distress. A few cases of overdosage have been reported, with complete recovery as the usual outcome. No deaths have been reported following overdosage with buspirone alone. Rare cases of intentional overdosage with a fatal outcome were invariably associated with ingestion of multiple drugs and/or alcohol, and a causal relationship to buspirone could not be determined. Toxicology studies of buspirone yielded the following LD 50 values: mice, 655 mg/kg; rats, 196 mg/kg; dogs, 586 mg/kg; and monkeys, 356 mg/kg. These dosages are 160 to 550 times the recommended human daily dose.
Recommended Overdose Treatment
General symptomatic and supportive measures should be used along with immediate gastric lavage. Respiration, pulse, and blood pressure should be monitored as in all cases of drug overdosage. No specific antidote is known to buspirone, and dialyzability of buspirone has not been determined.
The recommended initial dose is 15 mg daily (7.5 mg b.i.d.). To achieve an optimal therapeutic response, at intervals of 2 to 3 days the dosage may be increased 5 mg per day, as needed. The maximum daily dosage should not exceed 60 mg per day. In clinical trials allowing dose titration, divided doses of 20 to 30 mg per day were commonly employed.
The bioavailability of buspirone is increased when given with food as compared to the fasted state (see CLINICAL PHARMACOLOGY). Consequently, patients should take buspirone in a consistent manner with regard to the timing of dosing; either always with or always without food.
When buspirone is to be given with a potent inhibitor of CYP3A4 the dosage recommendations described in the PRECAUTIONS: Drug Interactions section should be followed.
Switching a Patient To or From a Monoamine Oxidase Inhibitor (MAOI) Antidepressant
At least 14 days should elapse between discontinuation of an MAOI intended to treat depression and initiation of therapy with buspirone hydrochloride tablets. Conversely, at least 14 days should be allowed after stopping buspirone hydrochloride tablets before starting an MAOI antidepressant CONTRAINDICATIONS and DRUG INTERACTIONS).
Use of buspirone hydrochloride tablets with (Reversible) MAOIs, Such as Linezolid or Methylene Blue
Do not start buspirone hydrochloride tablets in a patient who is being treated with a reversible MAOI such as linezolid or intravenous methylene blue because there is an increased risk of serotonin syndrome. In a patient who requires more urgent treatment of a psychiatric condition, non-pharmacological interventions, including hospitalization, should be considered (see CONTRAINDICATIONS and DRUG INTERACTIONS).
In some cases, a patient already receiving therapy with buspirone hydrochloride tablets may require urgent treatment with linezolid or intravenous methylene blue. If acceptable alternatives to linezolid or intravenous methylene blue treatment are not available and the potential benefits of linezolid or intravenous methylene blue treatment are judged to outweigh the risks of serotonin syndrome in a particular patient, buspirone hydrochloride tablets should be stopped promptly, and linezolid or intravenous methylene blue can be administered. The patient should be monitored for symptoms of serotonin syndrome for 2 weeks or until 24 hours after the last dose of linezolid or intravenous methylene blue, whichever comes first. Therapy with buspirone hydrochloride tablets may be resumed 24 hours after the last dose of linezolid or intravenous methylene blue (see WARNINGS).
The risk of administering methylene blue by non-intravenous routes (such as oral tablets or by local injection) or in intravenous doses much lower than 1 mg per kg with buspirone hydrochloride tablets is unclear. The clinician should, nevertheless, be aware of the possibility of emergent symptoms of serotonin syndrome with such use (see CONTRAINDICATIONS, WARNINGS and DRUG INTERACTIONS).
Buspirone Hydrochloride Tablets, USP are available as:
5 mg
100 tablets in a bottle
White to off white ovoid- rectangular uncoated functionally scored tablet with score line on one side and engraved '5' on the other side.
500 tablets in a bottle
7.5 mg
100 tablets in a bottle
White to off white colour, oval, biconvex tablets, debossed with 7.5 on one side and score line on other side.
10 mg 100 tablets in a bottle
White to off white ovoid- rectangular uncoated functionally scored tablet with score line on one side and engraved '10' on the other side.
500 tablets in a bottle
15 mg 500 tablets in a bottle
White to off white rectangular uncoated functionally scored tablet with bisected score lines on one side and trisected score line with engraved '5' on each trisection of other side. The 15 mg tablet is in xx tablet design and functionally scored so that it can be either bisected or trisected.
60 tablets in a bottle
30 mg
60 tablets in a bottle
White to off white rectangular uncoated functionally scored tablet with bisected score lines on one side and trisected score line with engraved '10' on each trisection of other side.
Store at 20 °C to 25 °C (68 °F to 77 °F); excursions permitted between 15 °C to 30 °C (59 °F to 86 °F) [See USP controlled room temperature]. Dispense in a tight, light-resistant container (USP).
Rx only
HOW TO USE BUSPIRONE HYDROCHLORIDE TABLETS, 15 mg
Response to buspirone varies among individuals. Your physician may find it necessary to adjust your dosage to obtain the proper response.
This tablet design makes dosage adjustments easy. Each tablet is scored and can be broken accurately to provide any of the following dosages:
To break a tablet accurately and easily, hold the tablet between your thumbs and index fingers close to the appropriate tablet score (groove) as shown below. Then, with the tablet score facing you, apply pressure and snap the tablet segments apart (segments breaking incorrectly should not be used).
HOW TO USE BUSPIRONE HYDROCHLORIDE TABLETS, 30 mg
Response to buspirone varies among individuals. Your physician may find it necessary to adjust your dosage to obtain the proper response.
This tablet design makes dosage adjustments easy. Each tablet is scored and can be broken accurately to provide any of the following dosages:
To break a tablet accurately and easily, hold the tablet between your thumbs and index fingers close to the appropriate tablet score (groove) as shown below. Then, with the tablet score facing you, apply pressure and snap the tablet segments apart (segments breaking incorrectly should not be used).
Distributed by:
Strides Pharma Inc.
East Brunswick, NJ 08816
Revised: 01/2021
Marketed/Packaged by:
GSMS, Inc.
Camarillo, CA USA 93012
Repackaging Information
Please reference the How Supplied section listed above for a description of individual tablets. This drug product has been received by Aphena Pharma - TN in a manufacturer or distributor packaged configuration and repackaged in full compliance with all applicable cGMP regulations. The package configurations available from Aphena are listed below:
Count 7.5 mg 90 71610-608-60
Store between 20°-25°C (68°-77°F). See USP Controlled Room Temperature. Dispense in a tight light-resistant container as defined by USP. Keep this and all drugs out of the reach of children.
Repackaged by:
Cookeville, TN 38506
- PRINCIPAL DISPLAY PANEL - 7.5 mg
buspirone hydrochloride tablet
Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:71610-608(NDC:51407-414) Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength BUSPIRONE HYDROCHLORIDE (UNII: 207LT9J9OC) (BUSPIRONE - UNII:TK65WKS8HL) BUSPIRONE HYDROCHLORIDE 7.5 mg Inactive Ingredients Ingredient Name Strength CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U) LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X) MAGNESIUM STEARATE (UNII: 70097M6I30) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2) WATER (UNII: 059QF0KO0R) Product Characteristics Color white Score 2 pieces Shape OVAL Size 10mm Flavor Imprint Code 7;5 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:71610-608-60 90 in 1 BOTTLE; Type 0: Not a Combination Product 10/26/2021 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA202330 02/17/2017 Labeler - Aphena Pharma Solutions - Tennessee, LLC (128385585) Establishment Name Address ID/FEI Business Operations Aphena Pharma Solutions - Tennessee, LLC 128385585 REPACK(71610-608)