Sunday, 19 August 2012

Conditions of Licence for Allopathic Loan Licence Manufacturing



Drugs & Cosmetics Rules, 1945 
Conditions of Licence for Allopathic Loan Licence 
Manufacturing 
74-B. Conditions of license in Form 25-A.-  

(1). The license in Form 25-A shall be deemed to be cancelled or suspended, if the 
license owned by the licensee in Form 25 whose manufacturing facilities have 
been availed of by the licensee is cancelled or suspended as the case may be, 
under these rules. 

(2). The licensee shall comply with the provisions of the Act and of these rules 
and with such further requirements if any, as may be specified in any rules 
subsequently made under Chapter IV of the Act; provided that where such 
further requirements are specified in the rules, these would come into force 
four months after publication in the Official Gazette.

(3). The licensee shall test each batch or lot of the raw material used by him for 
the manufacture of his products and also each batch of the final product and 
shall maintain records or registers showing the particulars in respect of such 
tests as specified in Schedule U. The records or registers shall be retained for 
a period of five years  from the date of manufacture. The licensee shall allow 
an Inspector to inspect all registers and records maintained under these rules 
and shall supply to the Inspector such information as he may require for the 
purpose of ascertaining whether the provisions of the Act and these rules have 
been observed. 

(4). The licensee shall either- 
(i). Provide and maintain to the satisfaction of the licensing 
authority adequate staff and adequate laboratory facilities for 
carrying out tests of strength, quality and purity fo he substances 
manufactured by him; or 
(ii). Make arrangements with some institution approved by the 
licensing authority [under Part XV(A) of these Rules] for such 
tests to be regularly carried out on his behalf by the institution.

(5). The licensee shall maintain reference samples from each batch of the drugs 
manufactured by him in a quantity which is at least twice  the quantity of the 
drug required to conduct all the tests performed on the batch. In case of drugs 
bearing an expiry date on the label the reference samples shall be maintained 
for a period of three months beyond the date of expiry of potency. 
      In case of drugs where no date of expiry of potency is specified on the label,      
the  reference samples shall be maintained for a period of three years from the 
date of manufacture. 

(6). The licensee shall maintain an Inspection Book in  Form 35 to enable an 
Inspector to record his impressions and the defects noticed. Drugs & Cosmetics Rules, 1945 

Conditions of Licence for Allopathic Drug Manufacturing 
74. Conditions of licence in [Form 25 and Form 25-F].- A licence in [Form 25 and 
Form 25-F] shall be subject to the conditions stated therein and to  the  following further 
conditions, namely- 

(a) the licensee shall provide and maintain staff, premise and the equipment as 
specified in Rule 71

(b) the licensee shall comply with the provisions of the Act and of these rules and 
with such further requirements, if any, as may be specified in any  rules 
subsequently made under Chapter IV of the Act, provided that where such 
further requirements are specified in the rules, these would come into force, 
four months after publication in the Official Gazette; 

(c) the licensee shall either in his own laboratory or in any other laboratory 
approved by the licensing authority [under Part XV(A) of these Rules] test 
each batch or lot of the raw material used by him for the manufacture of his 
products and also each batch of the final product and shall maintain records or 
registers showing the particulars in respect of such tests as specified in 
Schedule U. The records or registers shall be retained for a period of 5 years 
from the date of manufacture; 

(d)   the licensee shall keep records of the details of manufacture as per 
particulars given in Schedule U of each batch of the drugs manufactured by 
him and such records shall be retained for   a period of five years; 

(e) the licensee shall allow an [Inspector authorised by the Act] to enter, with or 
without prior notice, any premises and to inspect the plant and the process of 
manufacture and the means employed in standardizing and testing the drugs; 

(f) the licensee shall allow an [Inspector authorised by the Act] to inspect all 
registers and records maintained under these rules and to take samples of the 
manufactured drugs and shall supply to such Inspector such information as he 
may require for the purpose of ascertaining whether the provisions of the Act 
and the rules thereunder have been observed; 

(g) the licensee shall, from time to time, report to the licensing authority any 
changes in the expert staff responsible for the manufacture or testing of the 
drugs and any material alterations in the premises or plant used for the 
purpose which have  been made since the date of the last inspection made on 
behalf of the licensing authority; 

(h) the licensee shall, on request, furnish to the  licensing authority, the 
controlling authority or to such authorities as the licensing authority or the 
controlling authority may direct, from every batch or batches of drugs as the 
licensing authority or the controlling authority may from time to time specify, 
a sample of such quantity as may be considered adequate by such authority for 
any examination and, if so required, also furnish full protocols of tests which 
have been applied;
 (i) if the licensing authority [or the controlling authority] so directs and if 
requested by the licensee who had also furnished prim a facie reasons for such 
directions, the licensee shall not sell or offer for sale any batch in respect of 
which a sample is or protocols are furnished under clause (h) until a certificate 
authorising the sale of batch has been issued to him by or on behalf of the 
licensing authority [or the controlling authority]; 
(j) the licensee shall on being informed by the licensing authority [or the 
controlling authority] that any part of any batch of the drug has been found by 
the licensing authority [or the controlling authority] not to conform with the 
standards of strength, quality or purity specified in these rules and on being 
directed so to do, withdraw the remainder of the batch from sale, and, so far as 
may in the particular circumstances of the case be practicable, recall all issues 
already made from that batch; 
(k) the licensee shall maintain an Inspection Book in Form 35 to enable an 
Inspector to record his impressions and the defects noticed; 
(l) the licensee shall maintain reference samples from each batch of the drugs 
manufactured by him in a quantity which is at least twice the quantity of the 
drug required to conduct all the tests performed on the batch. In case of drugs 
bearing an expiry date on the label, the reference samples shall be maintained 
for a period of three months beyond the date of expiry of potency. In case of 
drugs where no daate of expiry of potency is specified on the label, the 
reference samples shall be maintained for a period of three years from the date 
of manufacture; 
(m) the licensee, who has been granted a license in Form 25-F, shall- 
(i). forward to the licensing authority of the concerned States of 
manufacture and supply of the drug a statement of the sales 
effected to the manufacturers, wholesalers, retailers, hospitals, 
dispensaries and nursing homes and Registered Medical 
Practitioners every three months; 
(ii).  maintain accounts of all transactions giving details as indicated 
below in a register bound and serially page numbered and such 
records shall be retained for a period of five years or one year 
after the expiry of potency, whichever is later:- 
A. Accounts of the drugs specified in Schedule X used for the 
manufacture:- 
1. Date of issue. 
2. Name of the drug. 
3. Opening balance of stock on the production day. 
4. Quantity received, if any, and source from where received. 
5. Quantity used in manufacture. 
6. Balance quantity on hand at the end of the production day. 
7. Signature of the person in charge. 
B. Accounts of production:- 1. Date of manufacture. 
2. Name of the drug. 
3. Batch Number. 
4. Quantity of raw material used in manufacture. 
5. Anticipated yield. 
6. Actual yield. 
7. Wastage. 
8. Quantity of the manufactured goods transferred. 
C. Accounts of the manufactured drugs:- 
1. Date of manufacture. 
2. Name of the drug. 
3. Batch Number. 
4. Opening Balance. 
5. Quantity manufactured. 
6. Quantity sold. 
7. Name of the purchaser and his address. 
8. Balance quantity at the end of the day. 
9. Signature of the person in charge. 
(n) The licensee shall store drugs specified in Schedule X in bulk form and when 
any of such drug is required for manufacture in a place other than its place of 
storage it shall be kept in a separate place under the direct custody of a 
responsible person. 
(o) The licensee shall comply with the requirements of ‘Good Manufacturing 
Practices’ as laid down in Schedule M. 
78. Conditions of licence.- A licence in Form 28, Form 28-B or Form 28-D shall be 
subject to the special conditions, if any, set out in Schedule F or Schedule F(1), as the 
case may be, which relate to substance in respect of which the licence is granted and to 
the following general conditions: 
(a)  
(i) The licensee shall provide and maintain an adequate staff and adequate  
                 premises and plant for the proper manufacture and storage of the                 
 substances in respect of which the licence is issued. 
(ii) Without prejudice to the generality of the foregoing requirements,   
                  every holder of a licence who for any purpose engaged in the culture              
       or manipulation of pathogenic spore-bearing micro-organisms shall     
       provide to the satisfaction of the Licensing Authority separate      
       laboratories and utensils and apparatus required for the culture or   
       manipulation of such micro-organisms, the laboratories, utensils and   
       apparatus so provided not being used for the manufacture of any other         
       substance. 
(b)  The licensee shall provide and maintain staff, promises and equipment                               
as specified in Rule 76. 
(c)  (i) The licensee shall maintain records of manufacture as per particulars     
given in Schedule U.  
(ii). The licensee shall either in his own laboratory or in any laboratory   
approved by the Licensing Authority under Part XV(A) to these Rules        
test each batch or lot of the raw material used by him for the 
manufacture of his product and also each batch of the final product          
and shall maintain records or registers showing the particulars in        
respect of such tests as specified in Schedule U. The records or          
registers shall be retained in the  case of a  substance for such date,           
and in the case of other substances for a period of five years from the          
date of manufacture. 
(d) The licensee shall allow an Inspector, appointed under the Act, to enter, 
with or without prior notice, any premises, where the manufacture is 
carried on and to inspect the premises, and in the case of substances 
specified in Schedule C and C(1), to inspect the plant and the process of 
manufacture and the means employed for standardizing and testing the 
substance. 
(e) The licensee shall allow an Inspector, appointed under the Act, to 
inspect all registers and records maintained under these rules and to take 
samples of the manufactured product and shall supply to each Inspector 
such information as he may require for the purpose of ascertaining 
whether the provisions of the Act and Rules thereunder have been 
observed. 
(f) The licensee shall from time to time report to the Licensing Authority 
any changes in the expert staff responsible for the manufacture or 
testing of the substances and any material alterations in the premises or 
plant used for that purpose which have been made since the date of the 
last inspection made on behalf of the Licensing Authority before the 
issue of the licence. 
(g) The licensee shall on request furnish to the Licensing Authority, 
controlling authority or to such authorities as the Licensing Authority or 
the controlling authority may direct, from every batch of drugs as the 
Licensing Authority or the controlling authority may from time to time 
specify, a sample of such quantity as may be considered adequate by 
such authority for any examination and, if so required, also furnish full 
protocols of the tests which have been applied. 
(h) If the Licensing Authority or the controlling authority so directs, the 
licensee shall not sell or offer for sale any batch in respect of which a 
sample is, or protocols are furnished under the last preceding subparagraph until a certificate authorizing the sale of the batch has been 
issued to him by or on behalf of the Licensing Authority or the 
controlling authority. 
(i) The licensee shall on being informed by the Licensing Authority or the 
controlling authority that any part of any batch of the substance has 
been found by the Licensing Authority or the controlling authority not 
to conform with the standards of strength, quality or purity specified in these Rules and on being directed so to do, withdraw the remainder of 
the case be practicable recall all issues already made from that batch. 
(j) No drug manufactured under the licence shall be sold unless the 
precautions necessary for preserving its properties have been observed 
throughout the period after manufacture. 
(k) The licensee shall comply with the provisions of the Act and of these 
rules and with such further requirements, if any, as may be specified in 
any rules subsequently made under Chapter IV of the Act, provided that 
where such further requirements are specified in the rules, these would 
come into force four months after publication in the Official Gazette. 
(l) The licensee shall maintain an Inspection Book in Form 35 to enable an 
Inspector to record his impressions and defects noticed. 
(m) The licensee shall maintain reference samples from each batch of the 
drugs manufactured by him in a quantity which is at least twice the 
quantity of the drug required to conduct all the tests performed on the 
batch. In case of  drugs bearing an expiry date on the label the reference 
samples shall be maintained for a period of three months beyond the 
date of expiry of potency. In case of drugs where no date of expiry of 
potency is specified on the label, the reference samples shall be 
maintained for a period of three years from the date of manufacture. 
(n) The licensee, who has been granted a license in Form 28-B shall- 
(i) Forward to the Licensing Authority of the concerned Stated of 
manufacture and supply of drug a statement of the sales effected 
to the manufactures, wholesalers, retailers, hospitals, dispensaries, 
Nursing Homes and Registered Medical Practitioners every three 
months. 
(ii) Maintain accounts of all transactions giving details as indicated 
below in a register bound and serially page numbered, and such 
records shall be retained for a period of five years or one year 
after the date of expiry of potency, whichever is later. 
A. Accounts of the drugs specified in Schedule X used for the 
manufacture:- 
1. Date of issue. 
2. Name of the drug. 
3. Opening balance of stock on the production day. 
4. Quantity received, if any, and source from where received. 
5. Quantity used in manufacture. 
6. Balance quantity on hand at the end of the production day. 
7. Signature of the person in charge. 
B. Accounts of Production:- 
1. Date of manufacture. 
2. Name of the drug. 
3. Batch Number. 
4. Quantity of raw material used in manufacture. 
5. Anticipated yield. 
6. Actual yield. 7. Wastage. 
8. Quantity of the manufactured goods transferred to stock. 
C. Accounts of manufactured drugs:- 
1. Date of manufacture. 
2. Name of the drug. 
3. Batch Number. 
4. Opening Balance. 
5. Quantity manufactured. 
6. Quantity sold. 
7. Name of the purchaser and his address. 
8. Balance quantity at the end of the day. 
(o) The licensee shall store drugs specified  in Schedule X in bulk form and 
when any such drug is required for manufacture it shall be kept in a 
separate place under direct custody of a responsible person. 
(p) The licensee shall comply with the requirements of ‘Good 
Manufacturing Practices’ as laid down in Schedule M. 
78-A.Conditions of licence in Form 28-A.        
(1). The licence in Form 28-A shall be deemed to be cancelled or suspended, if 
the licence owned by the licensee in Form 28 whose manufacturing facilities 
have availed of by the licensee is cancelled  or suspended, as the case may be, 
under these rules.
(2). The licensee shall comply with the provisions of the Act, and of these rules 
and with such further requirements if any, as may be specified in any rules 
subsequently made under Chapter IV of the Act, provided that where such 
further requirements are specified in the rules, those would come into force 
four months after publication in the official Gazette.
(3). The licensee shall test each batch or lot of the raw material used by him for 
the manufacture of his products and also each batch of the final product and 
shall maintain records or registers showing the particulars in respect of such 
tests as specified in the Schedule U. Records or registers shall be retained, in 
the case of a substance for which a potency date is fixed, for a period of two 
years from the expiry of such date and in the case of other substances, for a 
period of five years from the date of manufacture. The licensee shall allow an 
Inspector to inspect all registers and records maintained under these rules and 
shall supply to the Inspector such information as he may require for the 
purpose of ascertaining whether the provisions of the Act and these rules 
have been observed.
(4). The licensee shall either (1) provide and maintain to the satisfaction of the 
Licensing Authority adequate Laboratory facilities for carrying out tests of 
the Strength, quality and purity of the substances manufactured by him, or (2) 
make arrangements with some institution approved by the Licensing 
Authority for such tests to be regularly carried out on the behalf by the 
institution.
(5). The licensee shall furnish to the Licensing Authority, if required to do so, 
data on the stability of drugs which are likely to deteriorate for fixing the date of expiry which would be printed on the labels of such drugs on the basis of 
the data so furnished. 
(6). The licensee shall maintain reference samples from each batch of the drugs 
manufactured by him in a quantity which is atleast twice the quantity of the 
drug required to conduct all the tests performed on the batch. In case of drugs 
bearing an expiry date on the labels, the reference samples shall be 
maintained for a period of three months beyond the dated of expiry of 
potency. In case of drugs where no date of expiry of potency is specified on 
the label, the reference samples shall be maintained for a period of three 
years from the date of manufacture. 
(7). The licensee shall maintain an Inspection Book in Form 35 to enable an 
Inspector to record his impressions and the defects noticed. 

source: drugscontrol.org

Thursday, 16 August 2012

Drug Patent Expirations for the week of August 12, 2012


Drug Patent Expirations for the week of August 12, 2012

TradenameApplicantGeneric NamePatent NumberPatent Expiration
EXELONNovartisrivastigmine tartrate4,948,807Aug 14, 2012
EXELONNovartisrivastigmine4,948,807Aug 14, 2012
VITRAVENE PRESERVATIVE FREENovartisfomivirsen sodium5,442,049Aug 15, 2012
VITRAVENE PRESERVATIVE FREENovartisfomivirsen sodium5,595,978Aug 15, 2012
*Drugs may be covered by multiple patents or regulatory protections. See the DrugPatentWatch database for complete details.

Wednesday, 15 August 2012

HAPPY 66TH INDEPENDENCE DAY-INDIA


Jana Gana Mana Full Anthem Lyrics


Jana Gana Mana is a five-stanza Brahmo hymn composed and scored in a highly Sanskritized Bengali by Nobel laureate Rabindranath Tagore. The first stanza of the song has been adopted as the National Anthem of India.

Written By: Rabindranath Tagore
Composed and Scored by: Rabindranath Tagore
Release Date: Bengali song had been written in 1911
and adopted as National Anthem of India on 24 January 1950.



Stanza 1 (National Anthem of India)

Jana Gana Mana Adhinaayak Jaya Hey,
Bhaarat Bhaagya Vidhaataa
Panjaab Sindhu Gujarat Maraatha,
Draavid Utkal Banga
Vindhya Himaachal Yamuna Ganga, 
Uchchhal Jaladhi Taranga
Tav Shubh Naamey Jaagey, 
Tav Shubh Aashish Maange
Gaahey Tav Jayagaathaa
Jana Gana Mangal Daayak, 
Jaya Hey Bhaarat Bhaagya Vidhaataa
Jaya Hey, Jaya Hey, Jaya Hey,
Jaya Jaya Jaya, Jaya Hey




Stanza 2 (National Anthem of India)

Ohoroha Toba Aahbaana Prachaarita,
Suni Tab Udaar Vaani
Hindu Bauddh Shikha Jain,
Parasik Musolman Christaani
Purab Pashchim Aashey,
Tab Singhaasana Paashey
Premohaara Hawye Gaanthaa
Jana Gana Oikya Vidhaayak Jaya Hey,
Bhaarat Bhaagya Vidhaataa
Jaya Hey, Jaya Hey, Jaya Hey,
Jaya Jaya Jaya, Jaya Hey




Stanza 3 (National Anthem of India)

Potona Abhbhudaya Bandhura Pantha,
Yug Yug Dhaabit Yaatri
Hey Chir Saarathi, 
Tab Ratha Chakrey Mukharit Patha Din Raatri
Daarun Viplab Maajhey,
Tab Shankh dhwani Bajey
Sankat Dukh Trata
Jana Gana Path Parichaayak,
Jaya Hey Bhaarat Bhaagya Vidhaataa
Jayo Hey, Jayo Hey, Jayo Hey,
Jayo Jayo Jayo, Jayo Hey

Stanza 4 (National Anthem of India)

Ghor Timir Ghan Nibiro,
Nishithey Peedit Murchhit Deshey
Jagrat Chhil Tab Abichal Mangal,
Nato Nayan Animeshey
Duswapney Aatankey,
Raksha Kariey Ankey
Snehamayi Tumi Mata
Jana Gana Duhkh Trayak,
Jaya Hey Bharat Bhagya Vidhaataa
Jaya Hey, Jaya Hey, Jaya Hey,
Jaya Jaya Jaya, Jaya Hey




Stanza 5 (National Anthem of India)

Raatri Prabhatil Udil Ravichhabi, 
Purb Uday Giri Bhaaley
Gaahey Vihangam Punya Sumiran, 
Nav Jeevan Rash Dhaley
Tab Karunaarun Raage,
Nidrit Bhaarat Jagey
Tab Charane Nat Maatha
Jaya Jaya JayA Hey, Jaya Rajeshwar,
Bhaarat Bhaagya Vidhaataa
Jaya Hey, Jaya Hey, Jaya Hey,
Jaya Jaya Jaya, Jaya Hey

Source: lyricsmint.com

Friday, 10 August 2012

WHO Model List of Essential Drugs (EDL)






Explanatory notes      EDL by drug name

source: drugscontrol.org



1. ANAESTHETICS1.1 General anaesthetics and oxygen
ether, anaesthetic(1c, 2)inhalation
halothane(2)inhalation
ketamine(2)injection, 50 mg (as hydrochloride)/ml in 10-ml vial
nitrous oxide(2)inhalation
oxygeninhalation (medicinal gas)
*thiopental(2)powder for injection, 0.5 g, 1.0 g (sodium salt) in ampoule
1.2 Local anaesthetics
*bupivacaine(2, 9)injection, 0.25%, 0.5% (hydrochloride) in vial; injection for spinal anaesthesia, 0.5% in 4-ml ampoule to be mixed with 7.5% glucose solution
*lidocaineinjection, 1%, 2% (hydrochloride) in vial; injection for spinal anaesthesia, 5% in 2-ml ampoule to be mixed with 7.5% glucose solution; topical forms, 2-4%
*lidocaine + epinephrine (adrenaline)injection 1%, 2% (hydrochloride)+ epinephrine 1:200 000 in vial; dental cartridge 2% + epinephrine 1:80 000
Complementary drug
ephedrine(C)injection, 30 mg/ml in 1-ml ampoule(To prevent hypotension in spinal anaesthesia during delivery)
1.3 Preoperative medication and sedation for short-term procedures
atropineinjection, 1 mg (sulfate) in 1-ml ampoule
chloral hydratesyrup, 200 mg/5-ml
*diazepam(1b)injection, 5 mg/ml in 2-ml ampoule; tablet, 5 mg
*morphine(1a)injection, 10 mg (sulfate or hydrochloride) in 1-ml ampoule
*promethazineelixir or syrup, 5 mg (hydrochloride)/5-ml
2. ANALGESICS, ANTIPYRETICS, NON-STEROIDAL ANTI-INFLAMMATORY DRUGS (NSAIDs), DRUGS USED TO TREAT GOUT AND DISEASE MODIFYING AGENTS IN RHEUMATOID DISORDERS (DMARDs)2.1 Non-opioids and NSAIDs
acetylsalicylic acidtablet, 100-500 mg; suppository, 50-150 mg
*ibuprofentablet, 200 mg, 400 mg
paracetamoltablet, 100-500 mg; suppository, 100 mg; syrup, 125 mg/5-ml
2.2 Opioid analgesics
*codeine(1a)tablet, 30 mg (phosphate)
*morphine(1a)injection, 10 mg in 1-ml ampoule (sulfate or hydrochloride); oral solution, 10 mg (sulfate or hydrochloride)/5 ml; tablet, 10 mg (sulfate)
Complementary drug
*pethidine(A) (1a, 4)injection, 50 mg (hydrochloride) in 1-ml ampoule; tablet, 50 mg, 100 mg
2.3 Drugs used to treat gout
allopurinol(4)tablet, 100 mg
colchicine(7)tablet, 500 micrograms
2.4 Disease modifying agents used in rheumatoid disorders (DMARDs)
azathioprine(2)tablet, 50 mg
chloroquine(2)tablet, 100 mg, 150 mg (as phosphate or sulfate)
cyclophosphamide(2)tablet, 25 mg
methotrexate(2)tablet, 2.5 mg (as sodium salt)
penicillamine(2)capsule or tablet, 250 mg
sulfasalazine(2)tablet, 500 mg
3. ANTIALLERGICS AND DRUGS USED IN ANAPHYLAXIS
*chlorphenaminetablet, 4 mg (hydrogen maleate); injection, 10 mg (hydrogen maleate) in 1-ml ampoule
*dexamethasonetablet, 500 micrograms, 4 mg; injection, 4 mg dexamethasone phosphate (as disodium salt) in 1-ml ampoule
epinephrine (adrenaline)injection, 1 mg (as hydrochloride or hydrogen tartrate) in 1-ml ampoule
hydrocortisonepowder for injection, 100 mg (as sodium succinate) in vial
*prednisolonetablet, 5 mg
4. ANTIDOTES AND OTHER SUBSTANCES USED IN POISONING4.1 Non-specific
*charcoal, activatedpowder
ipecacuanhasyrup, containing 0.14% ipecacuanha alkaloids calculated as emetine
4.2 Specific
acetylcysteine (N-)injection, 200 mg/ml in 10-ml ampoule
atropineinjection, 1 mg (sulfate) in 1-ml ampoule
calcium gluconate(2, 8)injection, 100 mg in 10-ml ampoule
deferoxaminepowder for injection, 500 mg (mesilate) in vial
dimercaprol(2)injection in oil, 50 mg/ml in 2-ml ampoule
*dl-methioninetablet, 250 mg
methylthioninium chloride (methylene blue)injection, 10 mg/ml in 10-ml ampoule
naloxoneinjection, 400 micrograms (hydrochloride) in 1-ml ampoule
penicillamine(2)capsule or tablet, 250 mg
potassium ferric hexacyano-ferrate(II) ·2H20 (Prussian blue)powder for oral administration
sodium calcium edetate(2)injection, 200 mg/ml in 5-ml ampoule
sodium nitriteinjection, 30 mg/ml in 10-ml ampoule
sodium thiosulfateinjection, 250 mg/ml in 50-ml ampoule
5. ANTICONVULSANTS/ANTIEPILEPTICS
carbamazepine(10,11)scored tablet, 100 mg, 200 mg
*diazepam(1b)injection, 5 mg/ml in 2-ml ampoule (intravenous or rectal)
ethosuximidecapsule, 250 mg; syrup, 250 mg/5-ml
magnesium sulfateinjection, 500 mg/ml in 2-ml ampoule
phenobarbital(1b, 11)tablet, 15-100 mg; elixir, 15 mg/5-ml
phenytoin(7, 11)capsule or tablet, 25 mg, 50 mg, 100 mg (sodium salt); injection, 50 mg/ml in 5-ml vial
valproic acid(7, 11)enteric coated tablet, 200 mg, 500 mg (sodium salt)
Complementary drug
*clonazepam(B) (1b)scored tablets 500 micrograms
6. ANTI-INFECTIVE DRUGS6.1 Anthelminthics6.1.1 Intestinal anthelminthics
albendazolechewable tablet, 400 mg
levamisoletablet, 50 mg; 150 mg (as hydrochloride)
*mebendazolechewable tablet, 100 mg, 500 mg
niclosamidechewable tablet, 500 mg
praziquanteltablet, 150 mg, 600 mg
pyrantelchewable tablet 250 mg (as embonate); oral suspension, 50 mg (as embonate)/ml
6.1.2 Antifilarials
diethylcarbamazinetablet, 50 mg, 100 mg ( dihydrogen citrate)
ivermectinscored tablet, 3 mg, 6 mg
Complementary drug
suramin sodium(B) (2, 7)powder for injection, 1 g in vial
6.1.3 Antischistosomals and anti-trematode drugs
praziquanteltablet, 600 mg
triclabendazoletablet, 250 mg
Complementary drug
oxamniquine(C) (8)capsule, 250 mg; syrup, 250 mg/5-ml
6.2 Antibacterials6.2.1 Beta lactam drugs
*amoxicillin(4)capsule or tablet, 250 mg, 500 mg (anhydrous); powder for oral suspension, 125 mg (anhydrous)/5 ml
ampicillinpowder for injection, 500 mg, 1 g (as sodium salt) in vial
benzathine benzylpenicillinpowder for injection, 1.44 g benzylpenicillin (=2.4 million IU) in 5-ml vial
benzylpenicillinpowder for injection, 600 mg (= 1 million IU), 3 g (= 5 million IU) (sodium or potassium salt) in vial
*cloxacillincapsule, 500 mg, 1 g (as sodium salt); powder for oral solution, 125 mg (as sodium salt)/5 ml; powder for injection, 500 mg (as sodium salt) in vial
phenoxymethylpenicillintablet, 250 mg (as potassium salt); powder for oral suspension, 250 mg (as potassium salt)/5 ml
procaine benzylpenicillinpowder for injection, 1 g (=1 million IU), 3 g (=3 million IU)
Restricted Indications
*amoxicillin + *clavulanic acid(D)tablet, 500 mg + 125 mg
ceftazidime(D)powder for injection, 250 mg (as pentahydrate) in vial
*ceftriaxone(D)powder for injection, 250 mg (as sodium salt) in vial
imipenem + cilastatin(D)powder for injection 250 mg (as monohydrate) + 250 mg (as sodium salt), 500 mg (as monohydrate) + 500 mg (as sodium salt) in vial
6.2.2 Other antibacterials
*chloramphenicol(7)capsule, 250 mg; oral suspension, 150 mg (as palmitate)/5 ml; powder for injection, 1 g (sodium succinate) in vial
*ciprofloxacintablet 250 mg (as hydrochloride)
*doxycycline(5, 6)capsule or tablet, 100 mg (hydrochloride)
*erythromycincapsule or tablet, 250 mg (as stearate or ethyl succinate) ; powder for oral suspension, 125 mg (as stearate or ethyl succinate); powder for injection, 500 mg (as lactobionate) in vial
*gentamicin(2, 4, 7, 11)injection, 10 mg, 40 mg (as sulfate)/ml in 2-ml vial
*metronidazoletablet, 200-500 mg; injection, 500 mg in 100-ml vial; suppository, 500 mg, 1 g; oral suspension, 200 mg (as benzoate)/5 ml
nalidixic acid(8)tablet 250 mg, 500 mg
nitrofurantoin(4, 8)tablet, 100 mg
spectinomycin(8)powder for injection, 2 g (as hydrochloride) in vial
*sulfadiazine(4)tablet, 500 mg
*sulfadiazine(4)injection, 250 mg (sodium salt) in 4-ml ampoule
*sulfamethoxazole + trimethoprim(4)tablet, 100 mg + 20 mg, 400 mg + 80 mg; oral suspension, 200 mg + 40 mg/5 ml; injection, 80 mg + 16 mg/ml in 5-ml and 10-ml ampoules
trimethoprim(8)tablet, 100 mg, 200 mg; injection 20 mg/ml in 5-ml ampoule
Complementary drugs
chloramphenicol(C)oily suspension for injection 0.5 g (as sodium succinate)/ml in 2-ml ampoule
clindamycin(B) (8)capsule, 150 mg; injection, 150 mg (as phosphate)/ml
Restricted Indications
vancomycin(D)powder for injection, 250 mg (as hydrochloride) in vial
6.2.3 Antileprosy drugs
clofaziminecapsule, 50 mg, 100 mg
dapsonetablet, 25 mg, 50 mg, 100 mg
rifampicincapsule or tablet, 150 mg, 300 mg
6.2.4 Antituberculosis drugs
ethambutol(4)tablet, 100 mg-400 mg (hydrochloride)
isoniazidtablet, 100 -300 mg
isoniazid + ethambutol(5)tablet, 150 mg + 400 mg
pyrazinamidetablet, 400 mg
rifampicincapsule or tablet, 150 mg, 300 mg
rifampicin + isoniazid(5)tablet, 60 mg + 30 mg; 150 mg + 75 mg; 300 mg + 150 mg; 150 mg + 150 mg(For intermittent use three times weekly.)
rifampicin + isoniazid + pyrazinamide(5)tablet, 60 mg + 30 mg + 150 mg; 150 mg + 75 mg + 400 mg; 150 mg + 150 mg + 500 mg (For intermittent use three times weekly.)
rifampicin + isoniazid + pyrazinamide + ethambutoltablet, 150 mg + 75 mg +400 mg + 275 mg
streptomycin(4)powder for injection, 1 g (as sulfate) in vial
Complementary drug
thioacetazone + isoniazid(A) (5, 7)tablet, 50 mg + 100 mg; 150 mg + 300 mg
Restricted Indications
Additional reserve second-line drugs for the treatment of multidrug-resistant tuberculosis (MDR-TB) should be used in specialized centres adhering to WHO standards for TB control. (D)
6.3 Antifungal drugs
amphotericin B(4)powder for injection, 50 mg in vial
*fluconazolecapsule 50 mg; injection 2 mg/ml in vial; oral suspension 50 mg/5-ml
griseofulvin(7)capsule or tablet, 125 mg, 250 mg
nystatintablet, 100,000, 500,000 IU; lozenge 100,000 IU; pessary, 100,000 IU
Complementary drugs
flucytosine(B) (4, 8)capsule, 250 mg; infusion, 2.5 g in 250 ml
potassium iodide(A)saturated solution
6.4 Antivirals6.4.1 Antiherpes
aciclovir(8)tablet, 200 mg; powder for injection 250 mg (as sodium salt) in vial
6.4.2 Antiretrovirals
Adequate resources and specialist oversight are a prerequisite for the introduction of this class of drugs..
nevirapine(8)tablet 200 mg; oral solution 50 mg/5-mL
zidovudine(8)capsules 100 mg, 250 mg; injection, 10 mg/ml in 20-ml vial; oral solution 50 mg/5-ml
Drugs for treatment of HIV/AIDS include nucleoside reverse transcriptase inhibitors (NRTIs), non-nucleoside reverse transcriptase inhibitors (NNRTIs) and protease inhibitors (PIs). The drugs zidovudine and nevirapine have been shown to reduce or prevent mother-to-child transmission. THIS IS THE ONLY INDICATION FOR WHICH IT IS INCLUDED HERE. Single drug use with zidovudine, except in pregnancy, is now regarded as obsolete, because of the development of resistance. Triple therapy is beyond the budgets of most national drug programmes and therefore HIV/AIDS treatment policies must be decided at country or institutional level.
6.5 Antiprotozoal drugs6.5.1 Antiamoebic and antigiardiasis drugs
*diloxanidetablet, 500 mg (furoate)
*metronidazoletablet, 200-500 mg; injection, 500 mg in 100-ml vial; oral suspension 200 mg (as benzoate)/5 ml
6.5.2 Antileishmaniasis drugs
*meglumine antimoniateinjection, 30%, equivalent to approximately 8.5% antimony, in 5-ml ampoule
pentamidine(5)powder for injection, 200 mg, 300 mg (isetionate) in vial
Complementary drug
amphotericin B(B) (4)powder for injection, 50 mg in vial
6.5.3 Antimalarial drugs6.5.3.1 For curative treatment
*chloroquinetablet 100 mg, 150 mg (as phosphate or sulfate); syrup, 50 mg (as phosphate or sulfate)/5 ml; injection 40 mg (as hydrochloride, phosphate or sulfate)/ml in 5-ml ampoule
primaquinetablet, 7.5 mg, 15 mg (as diphosphate)
*quininetablet, 300 mg (as bisulfate or sulfate); injection, 300 mg (as dihydrochloride)/ml in 2-ml ampoule
Complementary drugs
*doxycycline(B)capsule or tablet, 100 mg (hydrochloride)(For use only in combination with chloroquine.)
mefloquine(B)tablet, 250 mg (hydrochloride)
*sulfadoxine + pyrimethamine(B)tablet, 500 mg + 25 mg
Restricted Indications
artemether(D)injection, 80 mg/ml in 1-ml ampoule
Restricted Indications
artesunate(D)tablet, 50 mg
6.5.3.2 For prophylaxis
chloroquinetablet, 150 mg (as phosphate or sulfate); syrup, 50 mg (as phosphate or sulfate)/5 ml
doxycyclinecapsule or tablet, 100 mg ( hydrochloride)
mefloquinetablet, 250 mg (as hydrochloride)
proguaniltablet, 100 mg (hydrochloride)(For use only in combination with chloroquine.)
6.5.4 Anti-pneumocystosis and anti-toxoplasmosis drugs
pentamidine(2)tablet 200 mg, 300 mg
pyrimethaminetablet, 25 mg
sulfamethoxazole + trimethopriminjection 80 mg + 16 mg in 5-ml ampoule
6.5.5. Antitrypanosomal drugs6.5.5 (a) African trypanosomiasis
melarsoprol(2)injection, 3.6% solution
pentamidine(5)powder for injection, 200 mg, 300 mg (isetionate) in vial
suramin sodiumpowder for injection, 1 g in vial
Complementary drug
eflornithine(C)injection, 200 mg ( hydrochloride)/ml in 100-ml bottles
6.5.5 (b) American trypanosomiasis
benznidazole(7)tablet, 100 mg
nifurtimox(2, 8)tablet, 30 mg; 120 mg; 250 mg
6.6 Insect repellents
diethyltoluamidetopical solution, 50%, 75%
7. ANTIMIGRAINE DRUGS7.1 For treatment of acute attack
acetylsalicylic acidtablet, 300 -500 mg
ergotamine(7)tablet, 1 mg (tartrate)
paracetamoltablet, 300-500 mg
7.2 For prophylaxis
*propranololtablet, 20 mg, 40 mg (hydrochloride)
8. ANTINEOPLASTIC, IMMUNOSUPPRESSIVES AND DRUGS USED IN PALLIATIVE CARE8.1 Immunosuppressive drugs
Adequate resources and specialist oversight are a prerequisite for this class of drugs.
*azathioprine(2)tablet, 50 mg; powder for injection, 100 mg (as sodium salt) in vial
*ciclosporin(2)capsule, 25 mg; concentrate for injection 50 mg/ml in 1-ml ampoule(For organ transplantation.)
8.2 Cytotoxic drugs
Adequate resources and specialist oversight are a prerequisite for this class of drugs.
asparaginase(2)powder for injection, 10,000 IU in vial
bleomycin(2)powder for injection, 15 mg (as sulfate) in vial
calcium folinate(2)tablet, 15 mg; injection, 3 mg/ml in 10-ml ampoule
chlorambucil(2)tablet 2 mg
chlormethine(2)powder for injection, 10 mg (hydrochloride) in vial
cisplatin(2)powder for injection, 10 mg, 50 mg in vial
cyclophosphamide(2)tablet, 25 mg; powder for injection, 500 mg in vial
cytarabine(2)powder for injection, 100 mg in vial
dacarbazine(2)powder for injection, 100 mg in vial
dactinomycin(2)powder for injection, 500 micrograms in vial
daunorubicin(2)powder for injection, 50 mg (as hydrochloride) in vial
*doxorubicin(2)powder for injection, 10 mg, 50 mg (as hydrochloride) in vial
etoposide(2)capsule, 100 mg; injection, 20 mg/ml in 5-ml ampoule
fluorouracil(2)injection, 50 mg/ml in 5-ml ampoule
levamisole(2)tablet, 50 mg (as hydrochloride)
mercaptopurine(2)tablet, 50 mg
methotrexate(2)tablet, 2.5 mg; powder for injection, 50 mg (as sodium salt) in vial
procarbazinecapsule, 50 mg (as hydrochloride)
vinblastine(2)powder for injection, 10 mg (sulfate) in vial
vincristine(2)powder for injection, 1 mg, 5 mg (sulfate) in vial
8.3 Hormones and antihormones
*prednisolonetablet, 5 mg; powder for injection, 20 mg in vial, 25 mg (as sodium phosphate or sodium succinate) in vial
tamoxifentablet, 10 mg, 20 mg (as citrate)
8.4 Drugs used in palliative care
The WHO Expert Committee on the Use of Essential Drugs recommended that all the drugs mentioned in the WHO publication Cancer Pain Relief: with a Guide to Opioid Availability, second edition, be considered essential. The drugs are included in the relevant sections of the Model List, according to their therapeutic use, e.g. analgesics.
9. ANTIPARKINSONISM DRUGS
*biperidentablet, 2 mg (hydrochloride); injection, 5 mg (lactate) in 1-ml ampoule
levodopa + *carbidopa(5, 6)tablet, 100 mg + 10 mg; 250 mg + 25 mg
10. DRUGS AFFECTING THE BLOOD10.1 Anti-anaemia drugs
ferrous salttablet, 60 mg iron; oral solution, 25 mg iron (as sulfate)/1 ml
ferrous salt + folic acidtablet equivalent to 60 mg iron + 400 micrograms folic acid(Nutritional supplement for use during pregnancy.)
folic acid(2)injection, 1 mg (as sodium salt) in 1-ml ampoule
hydroxocobalamin(2)injection, 1 mg in 1-ml ampoule
Complementary drug
*iron dextran(B) (5)injection, equivalent to 50 mg iron/ml in 2-ml ampoule
10.2 Drugs affecting coagulation
desmopressin(8)injection, 4 micrograms (acetate)/ml in 1-ml ampoule; nasal spray 10 micrograms/metered dose
heparin sodiuminjection, 1000 IU/ml, 5000 IU/ml, 20,000 IU (acetate)/ml in 1-ml ampoule
phytomenadioneinjection, 10 mg/ml in 5-ml ampoule; tablet, 10 mg
protamine sulfateinjection, 10 mg/ml in 5-ml ampoule
*warfarin(2, 6)tablet, 1 mg, 2 mg and 5 mg (sodium salt)
11. BLOOD PRODUCTS AND PLASMA SUBSTITUTES11.1 Plasma substitutes
*dextran 70injectable solution, 6%
*polygelineinjectable solution, 3.5%
11.2 Plasma fractions for specific use
All plasma fractions should comply with the WHO Requirements for the Collection, Processing and Quality Control of Blood, Blood Components, and Plasma Derivatives (Revised 1992). WHO Technical Report Series, No. 840, 1994, Annex 2.
Complementary drugs
*factor VIII concentrate(C) (2, 8)(dried)
*factor IX complex concentrate (coagulation factors, II, VII, IX, X)(C) (2, 8)(dried)
12. CARDIOVASCULAR DRUGS12.1 Antianginal drugs
*atenololtablet, 50 mg, 100 mg
glyceryl trinitratetablet (sublingual), 500 micrograms
*isosorbide dinitratetablet (sublingual), 5 mg
*verapamil(10)tablet, 40 mg, 80 mg (hydrochloride)
12.2 Antiarrhythmic drugs
*atenololtablet, 50 mg, 100 mg
digoxin(4, 11)tablet, 62.5 micrograms, 250 micrograms; oral solution 50 micrograms; injection 250 micrograms/ml in 2-ml ampoule.
lidocaineinjection, 20 mg (hydrochloride)/ml in 5-ml ampoule
verapamil(8, 10)tablet, 40 mg, 80 mg (hydrochloride); injection, 2.5 mg (hydrochloride)/ml in 2-ml ampoule
Complementary drugs
epinephrine (adrenaline)(C)injection 1 mg (as hydrochloride) in 1-ml ampoule
isoprenaline(C)injection, 20 micrograms (hydrochloride)/ml
*procainamide(B)tablet, 250 mg, 500 mg (hydrochloride); injection, 100 mg (hydrochloride)/ml in 10-ml ampoule
*quinidine(A) (7)tablet, 200 mg (sulfate)
12.3 Antihypertensive drugs
*atenololtablet, 50 mg, 100 mg
*captoprilscored tablet, 25 mg
*hydralazinetablet, 25 mg, 50 mg (hydrochloride); powder for injection, 20 mg (hydrochloride) in ampoule
*hydrochlorothiazidescored tablet, 25 mg
methyldopa(7)tablet, 250 mg
*nifedipine(10)sustained release formulations, tablet 10 mg
*reserpinetablet, 100 micrograms, 250 micrograms; injection, 1 mg in 1-ml ampoule
Complementary drugs
*prazosin(B)tablet, 500 micrograms, 1 mg
*sodium nitroprusside(C) (2, 8)powder for infusion, 50 mg in ampoule
12.4 Drugs used in heart failure
*captopril(4, 11)scored tablet, 25 mg
*digoxin(4, 11)tablet, 62.5 micrograms, 250 micrograms; oral solution, 50 micrograms/ml; injection, 250 micrograms/ml in 2-ml ampoule
dopamineinjection, 40 mg (hydrochloride)in 5-ml vial
*hydrochlorothiazidetablet, 25 mg, 50 mg
12.5 Antithrombotic drugs
acetylsalicylic acidtablet, 100 mg
Complementary drug
streptokinase(C)powder for injection, 100,000 IU, 750,000 IU in vial
12.6 Lipid-lowering agents
The WHO Expert Committee on Use of Essential Drugs recognizes the value of lipid-lowering drugs in treating patients with hyperlipidaemia. HMG-CoA reductase inhibitors, often referred to as "statins", are a family of potent and effective lipid-lowering drugs with a good tolerability profile. Several of these drugs have been shown to reduce the incidence of fatal and non-fatal myocardial infarction, stroke and mortality (all causes), as well as the need for coronary by-pass surgery . All remain very costly but may be cost effective for secondary prevention of cardiovascular disease as well as for primary prevention in some very high-risk patients. Since no single drug has been shown to be significantly more effective or less expensive than others in the group, none is included in the Model List; the choice of drug for use in patients at highest risk should be decided at the national level.
13. DERMATOLOGICAL DRUGS (topical)13.1 Antifungal drugs
benzoic acid + salicylic acidointment or cream, 6% + 3%
*miconazoleointment or cream, 2% (nitrate)
sodium thiosulfatesolution, 15%
Complementary drug
selenium sulfide(C)detergent-based suspension, 2%
13.2 Anti-infective drugs
*methylrosanilinium chloride (gentian violet)aqueous solution, 0.5%; tincture, 0.5%
neomycin sulfate + *bacitracinointment, 5 mg + 500 IU bacitracin zinc/g
*potassium permanganateaqueous solution 1:10 000
silver sulfadiazinecream, 1%, in 500-g container
13.3 Anti-inflammatory and antipruritic drugs
*betamethasone(3)ointment or cream, 0.1% (as valerate)
*calamine lotionlotion
*hydrocortisoneointment or cream, 1% (acetate)
13.4 Astringent drugs
aluminium diacetatesolution, 13% for dilution
13.5 Drugs affecting skin differentiation and proliferation
benzoyl peroxidelotion or cream, 5%
coal tarsolution, 5%
dithranolointment, 0.1%-2%
fluorouracilointment, 5%
*podophyllum resin(7)solution, 10-25%
salicylic acidsolution 5%
ureaointment or cream, 10%
13.6 Scabicides and pediculicides
*benzyl benzoatelotion, 25%
permethrincream 5%; lotion 1%
13.7 Ultraviolet blocking agents
Complementary drugs
topical sun protection agent with activity against UVA and UVB(C)cream, lotion or gel
14. DIAGNOSTIC AGENTS14.1 Ophthalmic drugs
fluoresceineye drops, 1% (sodium salt)
*tropicamideeye drops, 0.5%
14.2 Radiocontrast media
amidotrizoateinjection, 140-420 mg iodine (as sodium or meglumine salt)/ml in 20-ml ampoule
barium sulfateaqueous suspension
*iohexolinjection 140 -350 mg iodine/ml in 5-ml, 10-ml and 20-ml ampoule
*iopanoic acidtablet, 500 mg
*propyliodoneoily suspension, 500-600 mg/ml in 20-ml ampoule(For administration only into the bronchial tree.)
Complementary drug
*meglumine iotroxate(C)solution, 5-8 g iodine in 100-250 ml
15. DISINFECTANTS AND ANTISEPTICS15.1 Antiseptics
*chlorhexidinesolution, 5% ( digluconate) concentrate for dilution
*ethanolsolution, 70% (denatured)
*polyvidone iodinesolution, 10%
15.2 Disinfectants
*chlorine base compoundpowder (0.1% available chlorine) for solution
*chloroxylenolsolution, 5%
glutaralsolution, 2%
16. DIURETICS
*amiloride(4, 7, 8)tablet, 5 mg (hydrochloride)
*furosemidetablet, 40 mg; injection, 10 mg/ml in 2-ml ampoule
*hydrochlorothiazidetablet, 25 mg, 50 mg
spironolactone(8)tablet, 25 mg
Complementary drug
*mannitol(C)injectable solution, 10%, 20%
17. GASTROINTESTINAL DRUGS17.1 Antacids and other antiulcer drugs
aluminium hydroxidetablet, 500 mg; oral suspension, 320 mg/5 ml
*cimetidinetablet, 200 mg; injection, 200 mg in 2-ml ampoule
magnesium hydroxideoral suspension, 550 mg equivalent to magnesium oxide/10 ml
17.2 Antiemetic drugs
metoclopramidetablet, 10 mg (hydrochloride); injection, 5 mg (hydrochloride)/ml in 2-ml ampoule
*promethazinetablet, 10 mg, 25 mg (hydrochloride); elixir or syrup, 5 mg (hydrochloride)/5 ml; injection, 25 mg (hydrochloride)/ml in 2-ml ampoule
17.3 Antihaemorrhoidal drugs
*local anaesthetic, astringent and anti-inflammatory drugointment or suppository
17.4 Anti-inflammatory drugs
*hydrocortisone(B)suppository 25 mg (acetate); *retention enema
*sulfasalazine(2)tablet, 500 mg; suppository 500 mg; retention enema
17.5 Antispasmodic drugs
*atropinetablet, 0.6 mg (sulfate); injection, 1 mg (sulfate) in 1-ml ampoule
17.6 Laxatives
*sennatablet, 7.5 mg (sennosides) (or traditional dosage forms)
17.7 Drugs used in diarrhoea17.7.1 Oral rehydration
oral rehydration salts (for glucose-electrolyte solution)powder, 27.9 g/l; Components to reconstitute 1 litre of glucose-electrolyte solution:sodium chloride 3.5 g/l;
trisodium citrate dihydrate* 2.9 g/l; potassium chloride 1.5 g/l;
glucose, anhydrous 20.0 g/l
*Trisodium citrate dihydrate may be replaced by sodium bicarbonate (sodium hydrogen carbonate) 2.5g/l. However, as the stability of this latter formulation is very poor under tropical conditions, it is only recommended when manufactured for immediate use.
17.7.2 Antidiarrhoeal (symptomatic) drugs
*codeine(1a)tablet, 30 mg (phosphate)
18. HORMONES, OTHER ENDOCRINE DRUGS AND CONTRACEPTIVES18.1 Adrenal hormones and synthetic substitutes
*dexamethasonetablet 500 micrograms, 4 mg; injection 4 mg dexamethasone phosphate (as disodium salt) in 1-ml ampoule
hydrocortisonepowder for injection, 100 mg (as sodium succinate) in vial
*prednisolonetablet 1 mg, 5 mg
Complementary drug
fludrocortisone(C)tablet, 100 micrograms (acetate)
18.2 Androgens
Complementary drug
testosterone(C) (2)injection, 200 mg (enantate) in 1-ml ampoule
18.3 Contraceptives18.3.1 Hormonal contraceptives
*ethinylestradiol + *levonorgestreltablet, 30 micrograms + 150 micrograms
*ethinylestradiol + *levonorgestreltablet, 50 micrograms + 250 micrograms (pack of four)
*ethinylestradiol + *norethisteronetablet, 35 micrograms + 1.0 mg
levonorgestreltablets, 750 micrograms (pack of two)
Complementary drugs
*levonorgestrel(B)tablets, 30 micrograms
medroxyprogesterone acetate(B) (7, 8)depot injection, 150 mg/ml in 1-ml vial
norethisterone enantate(B) (7, 8)oily solution, 200 mg/ml in 1-ml ampoule
18.3.2 Intrauterine devices
copper-containing device
18.3.3 Barrier methods
condoms with or without spermicide (nonoxinol)
diaphragms with spermicide (nonoxinol)
18.4 Estrogens
*ethinylestradioltablet, 10 micrograms, 50 micrograms
18.5 Insulins and other antidiabetic agents
*glibenclamidetablets, 2.5 mg, 5 mg
insulin (soluble)injection, 40 IU/ml in 10-ml vial, 100 IU/ml in 10-ml vial
intermediate-acting insulininjection, 40 IU/ml in 10 ml vial; 100 IU/ml in 10 ml vial (as compound insulin zinc suspension or isophane insulin)
metformintablet, 500 mg (hydrochloride)
18.6 Ovulation inducers
*clomifene(2, 8)tablet, 50 mg (citrate)
18.7 Progestogens
norethisteronetablet, 5 mg
Complementary drug
medroxyprogesterone acetate(B)tablet, 5 mg
18.8 Thyroid hormones and antithyroid drugs
levothyroxinetablet, 50 micrograms, 100 micrograms (sodium salt)
potassium iodidetablet, 60 mg
*propylthiouraciltablet, 50 mg
19. IMMUNOLOGICALS19.1 Diagnostic agents
All tuberculins should comply with the WHO Requirements for Tuberculins (Revised 1985). WHO Expert Committee on Biological Standardization Thirty sixth report, WHO Technical Report Series, No. 745, 1987, Annex 1..
tuberculin, purified protein derivative (PPD)injection
19.2 Sera and immunoglobulins
All plasma fractions should comply with the WHO Requirements for the Collection, Processing and Quality Control of Blood, Blood Components and Plasma Derivatives (Revised 1992). WHO Expert Committee on Biological Standardization Forty-third report, WHO Technical Report Series, No. 840, 1994, Annex 2..
anti-D immunoglobulin (human)injection, 250 micrograms in single-dose vial
*antitetanus immunoglobulin (human)injection, 500 IU in vial
antivenom seruminjection
diphtheria antitoxininjection, 10,000 IU, 20,000 IU in vial
immunoglobulin, human normal(2)intramuscular injection
immunoglobulin, human normal(2, 8)intravenous injection
*rabies immunoglobulininjection, 150 IU/ml
19.3 Vaccines
All vaccines should comply with the WHO Requirements for Biological Substances..
19.3.1 For universal immunization
BCG
diphtheria
hepatitis B
measles
pertussis
poliomyelitis
tetanus
19.3.2 For specific groups of individuals
influenza
meningitis
rabies
rubella
typhoid
yellow fever
20. MUSCLE RELAXANTS (PERIPHERALLY ACTING) AND CHOLINESTERASE INHIBITORS
*alcuronium chloride(2)injection, 5 mg/ml in 2-ml ampoule
*neostigminetablet, 15 mg (bromide); injection, 500 micrograms in 1-ml ampoule; 2.5 mg (metilsulfate) in 1-ml ampoule
pyridostigmine bromide(2, 8)tablet, 60 mg; injection, 1 mg in 1-ml ampoule
suxamethonium chloride(2)injection, 50 mg/ml in 2-ml ampoule; powder for injection
Complementary drug
vecuronium bromide(C)powder for injection, 10 mg in vial
21. OPHTHALMOLOGICAL PREPARATIONS21.1 Anti-infective agents
*gentamicinsolution (eye drops), 0.3% (sulfate)
*idoxuridinesolution (eye drops), 0.1%; eye ointment, 0.2%
silver nitratesolution (eye drops), 1%
*tetracyclineeye ointment, 1% (hydrochloride)
21.2 Anti-inflammatory agents
*prednisoloneeye drops, 0.5% (sodium phosphate)
21.3 Local anaesthetics
*tetracainesolution (eye drops), 0.5% (hydrochloride)
21.4 Miotics and antiglaucoma drugs
acetazolamidetablet, 250 mg
*pilocarpinesolution (eye drops), 2%, 4% (hydrochloride or nitrate)
*timololsolution (eye drops), 0.25%, 0.5% (as maleate)
21.5 Mydriatics
atropinesolution (eye drops), 0.1%; solution 0.5%, 1% (sulfate)
Complementary drug
epinephrine (adrenaline)(A)solution (eye drops), 2% (as hydrochloride)
22. OXYTOCICS AND ANTIOXYTOCICS22.1 Oxytocics
*ergometrinetablet, 200 micrograms (hydrogen maleate); injection, 200 micrograms (hydrogen maleate) in 1-ml ampoule
oxytocininjection, 10 IU in 1-ml ampoule
22.2 Antioxytocics
*salbutamol(2)tablet, 4 mg (as sulfate); injection, 50 micrograms (as sulfate)/ml in 5-ml ampoule
23. PERITONEAL DIALYSIS SOLUTION
intraperitoneal dialysis solution (of appropriate composition)parenteral solution
24. PSYCHOTHERAPEUTIC DRUGS24.1 Drugs used in psychotic disorders
*chlorpromazinetablet, 100 mg (hydrochloride); syrup, 25 mg (hydrochloride)/5ml; injection, 25 mg (hydrochloride)/ml in 2-ml ampoule
*fluphenazine decanoate(5)injection, 25 mg (decanoate or enantate) in 1-ml ampoule
*haloperidoltablet, 2 mg, 5 mg; injection, 5 mg in 1-ml ampoule
24.2 Drugs used in mood disorders24.2.1 Drugs used in depressive disorders
*amitriptylinetablet, 25 mg (hydrochloride)
24.2.2 Drugs used in bipolar disorders
carbamazepine(10, 11)scored tablet, 100 mg, 200 mg
lithium carbonate(2, 4)capsule or tablet, 300 mg
valproic acid(7, 11)enteric coated tablet, 200 mg, 500 mg (sodium salt)
24.3 Drugs used in generalized anxiety and sleep disorders
*diazepam(1b)scored tablet, 2 mg, 5 mg
24.4 Drugs used for obsessive compulsive disorders and panic attacks
clomipraminecapsules, 10 mg, 25 mg (hydrochloride)
25. DRUGS ACTING ON THE RESPIRATORY TRACT25.1 Antiasthmatic drugs
*aminophylline(2)injection, 25 mg/ml in 10 ml ampoule
*beclometasoneinhalation (aerosol), 50 micrograms per dose (dipropionate); 250 micrograms (dipropionate) per dose
*epinephrine (adrenaline)injection, 1 mg (as hydrochloride or hydrogen tartrate) in 1-ml ampoule
*ipratropium bromideinhalation, 20 micrograms/metered dose
*salbutamoltablet, 2 mg, 4 mg; inhalation (aerosol), 100 micrograms (as sulfate) per dose; syrup, 2 mg/5 ml; injection, 50 micrograms (as sulfate)/ml in 5-ml ampoule; respirator solution for use in nebulizers, 5 mg (as sulfate)/ml
*theophylline(10, 11)tablet, 100 mg, 200 mg, 300 mg
Complementary drug
*cromoglicic acid(B)inhalation (aerosol), 20 mg (sodium salt) per dose
25.2 Antitussives
*dextromethorphan(1a)oral solution, 3.5 mg (bromide)/5 ml
26. SOLUTIONS CORRECTING WATER, ELECTROLYTE AND ACID-BASE DISTURBANCES26.1 Oral
oral rehydration salts (for glucose-electrolyte solution)see section 17.7.1
potassium chloridepowder for solution
26.2 Parenteral
glucoseinjectable solution, 5% isotonic, 10% isotonic; 50% hypertonic
glucose with sodium chlorideinjectable solution, 4% glucose, 0.18% sodium chloride (equivalent to Na+ 30 mmol/l, Cl- 30 mmol/l)
potassium chloride(2)solution, 11.2% in 20-ml ampoule, (equivalent to K+1.5 mmol/ml, Cl- 1.5 mmol/ml)
sodium chlorideinjectable solution, 0.9% isotonic (equivalent to Na+154 mmol/l, Cl- 154 mmol/l); injectable solution, 0.18% (Na+ 30 mmol/l, Cl- 30 mmol/l) + glucose, 4%
sodium hydrogen carbonateinjectable solution, 1.4% isotonic (equivalent to Na+167 mmol/l, HCO3- 167 mmol/l); solution, 8.4% in 10-ml ampoule (equivalent to NA+ 1000 mol/l, HCO3-1000 mol/l)
*sodium lactate, compound solutioninjectable solution
26.3 Miscellaneous
water for injection2-ml, 5-ml, 10-ml ampoules
27. VITAMINS AND MINERALS
ascorbic acidtablet, 50 mg
*ergocalciferolcapsule or tablet, 1.25 mg (50,000 IU); oral solution, 250 micrograms/ml (10,000 IU/ml)
iodine(8)iodized oil, 0.5 ml (240 mg of iodine/ml), 1 ml (480 mg iodine/1 ml) in ampoule (oral or injectable); solution, 0.57 ml (308 mg iodine) in dispenser bottle; capsule, 200 mg.
*nicotinamidetablet, 50 mg
pyridoxinetablet, 25 mg (hydrochloride)
*retinolsugar-coated tablet, 10,000 IU (as palmitate) (5.5 mg); capsule, 200,000 IU (as palmitate) (110 mg); oral oily solution 100,000 IU (as palmitate)/ml in multidose dispenser; water-miscible injection 100,000 IU (as palmitate) (55 mg) in 2-ml ampoule
riboflavintablet, 5 mg
*sodium fluoridein any appropriate formulation
thiaminetablet, 50 mg (hydrochloride)
Complementary drug
calcium gluconate(C), (2, 8)injection, 100 mg/ml in 10-ml ampoule