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Excipients with Known Action


Announcement: List of Excipients with Known effect available in the medicines authorized for use in Lebanon

Date March 5th, 2024

The Lebanese National Pharmacovigilance Program (LNPVP) at the Ministry of Public Health (MoPH) has undertaken a comprehensive review of the available medicines authorized for use in the Lebanese market, with the collaboration and support of drug distributors and Marketing Authorization Holders (MAH) who actively contributed to the project.

The Role of Excipients in Medicines

According to the European Medicines Agency (EMA), excipients, constituents in medicines excluding the active substance, play crucial roles in drug formulation. These roles range from aiding in manufacturing processes to enhancing stability, bioavailability, and patient acceptability.

Understanding Excipients with Known Effect in Drug Formulation

Excipients contribute to product identification, overall safety attributes, effectiveness, and the delivery of the drug in use. Additionally, they play a key role in maintaining the integrity of drug products during storage. Although excipients are generally considered 'inert’, it is important to note that some may have a recognized action or effect in specific circumstances. Excipients with known effects may pose challenges in sensitive patients (those with allergies or specific intolerance syndromes), necessitating particular precautions during use. Therefore, to ensure the highest level of safety, it is advisable to consider these excipients when prescribing, dispensing, or providing advice on any medication.

The objective of the project

The main objective of the project was to establish a thorough compilation of excipients with known effects present in medications authorized for use in the Lebanese market in 2024. This compilation specifically focused on drugs for which input was received from both drug distributors and Marketing Authorization Holders (MAHs). As such the list is not exhaustive, and Healthcare professionals should give special care to controlling the excipients when prescribing or dispensing any medication.The received list underwent rigorous cleaning, validation, and compilation processes to serve as a valuable reference for identifying excipients with known effects that might be subject to inquiry.

List of Excipients with Known effect available in the medicines authorized for use in Lebanon
 
Excipients with a Known Effect List to be filled by the drug distributors
 
On behalf of the Lebanese National Pharmacovigilance Program (LNPVP) at the Ministry of Public Health (MoPH), we kindly request to provide information regarding your products in the context of a project on “Excipients with a Known Effect or Action”. 

The information related to pharmaceutical excipients with known effects is important in pharmacy practice. In general, excipients are considered to be ‘inert’. Whilst it is desirable that excipients should have little or no pharmacological action of their own, some do indeed have a recognized action or effect in certain circumstances. Excipients with a known effect have the particularity of being poorly tolerated in sensitive patients (allergic or presenting a particular intolerance syndrome) and require certain precautions for use. Consequently, in order to guarantee the best level of safety, it is useful to take these excipients into account when prescribing, dispensing or even advising of any medication.

The project aims to provide a list of drugs marketed in Lebanon with their corresponding excipients that have a known action or effect in certain circumstances.
 
You are therefore kindly requested to identify, from the provided list (Excipients with a Known Effect List to be filled by the drug distributors), the excipients with a known effect that are present in your corresponding drug products.

To this end, you are kindly invited to apply the following instructions:

The below link for the excel sheet (Excipients with a Known Effect List to be filled by the drug distributors) is a list of the products marketed in Lebanon with their relevant information. It is extracted from the latest Drugs Public Price List from the MoPH’s official website. (extracted on 7th March, 2023) Excipient List to be filled by drug distributors in Lebanon
 
For each of your products:
  1. In the “Agent” column (Column C), apply the filter to choose your company name; this will display only your products in the “Brand name” column (Column D).
  2. In the “Excipients” column (Column K), choose for each of your products the identified excipients from the dropdown list provided. To access the dropdown list, select the cell (under the ‘Excipient” column) corresponding to each product; a downwards arrow will appear at the lower-right corner of the cell. Select it and choose from the provided list of excipients.
  3. If your product contains more than one excipient, include each in a separate column (Columns M and O). Add as much columns as needed. If your product doesn’t contain any of the listed excipients, select the “None” option from the excipients’ dropdown list.
  4. Fill the “Route of Administration” column (Column J) appropriately using the drop down list. (Capitalize only the first letter)
  5. Fill the “Comment” column (Column Q) with any information present on the label and /or package leaflet regarding the identified excipients. If nothing is mentioned keep the cell blank.
  6. Please refer to raw number 4 as an example.
  7. Send us the filled excel sheet at the following email addresses: excipients.moph@gmail.com or excipients@moph.gov.lb
  8. Ensure that your file is named as follow: (name of the distributor-excipientlist2023),Example: Mersaco-excipientlist2023
 
You are kindly expected to reply back within 2 months after receiving this email (by May 31st, 2023), the latest.
 
Thank you for your time and cooperation.

Reminder,

Reference to previous communication related to the submission of Excipients with a known Action list, we would like to kindly remind all drug distributers and local manufacturers to complete this list by May 31st, 2023.

As per the previously shared instruction, the list must be filled out with utmost accuracy. It is essential to carefully select the appropriate excipient(s) and indicate the salt with its corresponding dose in the excipient dose section. Additionally, it is important to include any relevant package leaflet information in the comment section. We stress the importance of adhering to these instructions to ensure the safety and efficacy of medication use.

In case there are there are no excipients with known action in your corresponding products, please verify this by an email to excipients.moph@gmail.com.

We appreciate your cooperation in this matter.

Quality Assurance of Pharmaceutical Products Department
Lebanese National Pharmacovigilance Program
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ATC Name B/G Ingredients Dosage Form Price
C01BC04 FLECAINIDE BIOGARAN L.P. G Flecainide acetate - 50mg 50mg Capsule, extended release 1,154,361 L.L
J01AA08 VULGA XR G Minocycline - 55mg 55mg Tablet, film coated 1,983,512 L.L
L01EA01 IMATINIB SPC G Imatinib - 400mg 400mg Tablet, film coated 62,161,280 L.L
M01AB05 DICLOGESIC 12.5 CHILDREN G Diclofenac sodium - 12.5mg 12.5mg Suppository 83,318 L.L
N01AX10 DORMIFOR G Propofol - 1% 1% Injectable emulsion 1,081,473 L.L
N03AX14 LEVETIRACETAM BIOGARAN G Levetiracetam - 250mg 250mg Tablet, coated, scored 1,350,562 L.L
N05BA25 SEDOXIL G Mexazolam - 1mg 1mg Tablet 1,705,336 L.L
P02CB01 VERMIFUGE G Piperazine citrate - 1g/5ml 1g/5ml Syrup 148,463 L.L
V07AB01 EAU POUR PREPARATION INJECTABLE PROAMP G Water for injection - Water for injection, irrigation 1,240,367 L.L
A10BB12 ORBIDE G Glimepiride - 4mg 4mg Tablet 357,078 L.L
B01AB12 HIBOR G Bemiparin Sodium - 3,500IU 3,500IU Injectable solution 1,029,383 L.L
B05BB02 DEXTROSE 5% SODIUM CHLORIDE 0.9% INJECTION, USP G Sodium chloride - 0.9%, Glucose - 5% Injectable solution 186,167 L.L
C09DX01 ARBITEN AM PLUS G Valsartan - 160mg, Amlodipine - 5mg, Hydrochlorothiazide - 12.5mg Tablet 857,372 L.L
D06AX DERMOTRACIN G Neomycin sulfate - 165.000IU/150ml, Bacitracin - 15.500IU/150ml Powder 737,770 L.L
J01EE01 PAEDIATRIC CO-TRIMOXAZOLE MIXTURE G Trimethoprim - 40mg/5ml, Sulfamethoxazole - 200mg/5ml Suspension 190,698 L.L
L01EA01 SAGITTA G Imatinib - 400mg 400mg Capsule, hard 51,723,840 L.L
L02BA01 TAMOXIFENE BIOGARAN G Tamoxifen (citrate) - 10mg 10mg Tablet 415,247 L.L
N01AX10 PROPOFOL 1% MCT/LCT FRESENIUS G Propofol - 1% 1% Injectable emulsion 847,965 L.L
N03AX14 LEVIPRAM 250 G Levetiracetam - 250mg 250mg Tablet, film coated 1,087,873 L.L
N05CD08 MIDAZOLAM HAMELN G Midazolam (HCl) - 5mg/5ml 5mg/5ml Injectable solution 529,474 L.L
P02CB01 PIPERAZINE CITRATE G Piperazine citrate - 750mg/5ml 750mg/5ml Elixir 113,907 L.L
R06AB02 HISTAMED G Dexchlorpheniramine maleate - 1% 1% Gel 477,384 L.L
V07AB01 EAU POUR PREPARATION INJECTABLE PROAMP G Water for injection - Water for injection, irrigation 1,034,759 L.L
A10BB12 JOSWE GLEMAX 6 G Glimepiride - 6mg 6mg Caplet 663,858 L.L
B01AB12 HIBOR G Bemiparin Sodium - 5,000IU 5,000IU Injectable solution 1,466,132 L.L
B05BB02 MIXTE SIMPLE (2) G Sodium chloride - 0.9g/100ml, Dextrose, H2O - 5g/100ml Injectable solution 182,720 L.L
C01BD01 AMIODARONE BIOGARAN G Amiodarone (HCl) - 200mg 200mg Tablet 345,368 L.L
C09DX01 LOTEVAN PLUS G Valsartan - 160mg, Amlodipine - 5mg, Hydrochlorothiazide - 12.5mg Tablet, film coated 857,372 L.L
D06AX PENICILLIN DERMIC OINTMENT G Penicillin - 5,000IU 5,000IU Ointment 80,631 L.L
J01AA12 TAGIX G Tigecycline - 50mg 50mg Injectable lyophilised powder for solution 2,436,386 L.L
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