E-DRUG: Use of Cotrimoxazole (Sulfametoxazole/Trimetoprim) suspension
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Bactrim/Cotrimoxazole (Sulfametoxazole/Trimetoprim) suspension is one of
the widely used antibiotics for treatment of different types of bacterial
infection. Could someone discuss about the appropriate use of Cotrimoxazole
suspension for pediatrics once the bottle is opened for use. The practice
is different here from a week to a month. Is it for a week? for 2 weeks?
or a month or...? . I think, the recommendation for suspension use is one
month after the container is opened (if there is no other description by
the manufacture). I have also read from MSF Essential practical guidelines
2010th edition, cotrimoxazole suspension should be used for maximum of 7
days once the bottle is opened. But, there is no information with this
regard in the leaflets and packs of Bactrim/Septra/Cotrimoxazole
preparations. Could you share some information about this?
My question is related to the prevention of HIV-related Opportunistic Infections for pediatric patients and the reason I mentioned this is there is nothing stated in the label or product description (but I got one guideline saying for a week) and I also know some pharmacists dispensed for 2 weeks to 1 month. If we provide for a week we will dispense 4 bottles for a patient. Logistic issue??? specially for developing countries. Of-course we will not compromise just for the sake of logistics if it is not acceptable clinically or have no advantage in doing this. You may send me resources related with this.
Thank you
Seid Bati
Pharmacist
working in Ethiopia
<seidbati@gmail.com>
E-DRUG: Use of Cotrimoxazole (Sulfametoxazole/Trimetoprim) suspension (3)
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Dear Seid
Cotrimoxazole dry powder for oral suspension comes as a dry powder in a bottle. One needs to add an amount of potable water as stated on the label by the manufacturer to reconstitute (make) the powder into a suspension. The reconstituted suspension is often stable for 7-10 days from the date water is added- most of them require refrigeration after reconstitution. it cannot be used beyond 7-10 days. The dry powder for oral suspension is therefore not suitable for long term use since the patient has to throw away any remaining reconstituted suspension after 7 days and then has to prepare a fresh bottle.
Cotrimoxazole dispersible tablets or tablets for oral suspensionare similar to the dry powder for oral suspension, have the advantage that each dose of the "dry powder" is compacted into a tablet. One needs to reconstitute only one or two tablets in a small volume of potable water at the time of use. There is no concern for storage of the "reconstituted tablet" as it is used immediately and only the number of tablets required for each dose is reconstituted. The remaining tablets are safe and intact until they are required for administration to the patient.
Cotrimoxazole ready to use suspension comes ready to use. The general rule of thumb is that once opened, it should be discarded within one month, but, depending on the formulation, each manufacturer may have variations. For such products, manufacturers are required to conduct in-use stability studies and provide this information with the product. In the context of frequent use, I would advise that the manufacturer be required to provide oral syringes with adaptors that make it possible to draw the amount of liquid required from the bottle without dipping the syringe in the suspension.
Cotrimoxazole powder for oral suspension and ready to use suspension were not originally designed for long term use, but for short term antimicrobial therapy. For longer term use. and where there are challenges with maintaining the integrity of the product during use, I would advise that you consider the Cotrimoxazole tablets for oral suspension/dispersible tablets.
I am happy to provide more information
Atieno Ojoo
Technical Specialist, pharmaceuticals
Unicef Supply Division
Unicef Plads, Freeport
2100 Copenhagen
Denmark
Tel; +45 35 27 31 03
Fax: +45 35 26 94 21
http//www.unicef.org/supply
Email: atisojoo@yahoo.co.uk
E-DRUG: Use of Cotrimoxazole (Sulfametoxazole/Trimetoprim) suspension (4)
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Dear Said Bati
Dry Powdered suspensions are the ones which are not stable for long and usually lose potency after 7 days of reconstitution. When the same is stored in a refrigerator at 2-8 degrees centigrade it is stable for 14 days.
All suspensions which are in ready to use form are stable till their expiration date indicated by the manufacturer irrespective of the date of opening provided they are stored at the recommended storage conditions stipulated by the manufacturer. Usually in cool, dry place, away from direct sunlight and temperatures below 25 degrees centigrade but in tropical climate below 30 degrees is acceptable.
Fayyaz Mohammedtaqi BPharm; MSc (Clin Pharm)
Manager, Pharmacy Services
The Aga Khan Hospital (Dar es Salaam)
Tel: +255 22 2115151/2/3/4 Ext. 4592
chiefpharmacist@akhst.org
"Fayyaz taqiMohammed" <fajata@hotmail.com>
E-DRUG: Use of Cotrimoxazole (Sulfametoxazole/Trimetoprim) suspension (5)
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Thank you for the information on Cotrimaxazole suspension . Has that difference in potency after reconstitution of dry powder of Cotrimoxazole and suspension of Cotrimoxazole been presented and accepted in any International Conference? What about the WHO word on it?
Dr J Chembele,
Dodoma
Tanzania
Jacob chembele <chembelej@yahoo.com>
E-DRUG: Shelf life of proprietary liquid preparations after opening
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Dear ALL,
I believe the expiry date as noted on the label of proprietory liquid
formulations holds true so long the phial is not opened or the seal is not
broken and provided that the storage conditions as recommended by the
manufacturer is complied with. In resource poor settings (incidentally a
major proportion of such settings are located in tropical climates, zone
IV), complete compliance of storage recommendations is hardly achieved,
besides the fact that the contents of a liquid formulation phial may be
consumed over a period of many months for different patients.
In my understanding this practice runs the risk of using medications that might
have been decomposed/ degraded / lost their potency. I suppose there should
be clear instructions on the label of a liquid medicinal formulation about
how long it can be used safely after the seal is broken.
I invite comments of others on this issue.
Dr Santanu K Tripathi, MD, DM
Professor of Clinical Pharmacology
Calcutta School of Tropical Medicine
Kolkata 700073, INDIA
Phone 0-9230566771
Santanu Tripathi <tripathi.santanu@gmail.com>
E-DRUG: Shelf life of proprietary liquid preparations after opening (3)
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In most cases these types of formulations lack the information on how long they can be used after been opened on their label. I am not sure if even the dispensers do mention anything on this to patients/caretakers. Should this be a requirement for the manufacturers who produce these formulation?
Are there study findings on the quality of liquid preparations which have been kept for long after they have been opened? (Temperature zone specific)
Anybody with informations on how long ARVs liquid preparations can be used after being opened in the tropical zone please help.
[It is the moderator's view that shelflife of preparations in liquid oral preparation after opening depends on whether it is preserved or not. Chemically it will normally be as stable as if it was not opened, but it will be liable to microbial contamination once you open it and start to use it. Such general shelflife recommendations for different dosage forms is in many European countries at least developed by regulatory bodies put in a general guideline. As an aswer to your question, I assume ARV liquid formulations will be as stable as a bottle that has not yet been opened.]
Vicent Manyilizu
Pharmacist working in Tanzania
vicentmanyilizu@yahoo.com
E-DRUG: Shelf life of proprietary liquid preparations after opening (2)
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Dear Dr Santanu,
I believe you are referring to the utilization shelf life for which the
drug control authorities now are requiring manufacturers to declare using
documented "In-use stability study", this is for multi-dose products.
This varies depends on the product, some products have two weeks shelf life
after opening, some other are stable all over the whole shelf life of the
product.
Thanks and best regards
Ahmed Abdelwahab
Kuala Lumpur
abdelwahab@gmail.com
E-DRUG: Shelf life of proprietary liquid preparations after opening (6)
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[The debate is now closed as nothing new has been added. The topic remains unresolved. Moderator]
Dear all:
I agree with Dr Santanu.
Often, the shelf life after opening is unknown to most of the nurses. As it
is not written on the bottle.
When nurses are the ones who really need to know this info as unused/balance drug are often kept in the fridge for next use.
They often call up the Pharmacy to enquire and we will need to check in the
product insert.
I feel that this important information on ' stability of drug after
opening/after reconstitution' should be on the label for easy access of
information to our end users eg nurses/administrators of medicines.
Thank you
Michelle Tan Hwee Pheng
Drug Information Pharmacist
PPUKM
9145-5401
hptan@ppukm.ukm.my