Diclofenac sodium suppositories

The result may be in this case Diclofenac sodium suppositories 12.5 mg, followed by a list of the excipients, for example hard fat and lactose... 

In the case of diclofenac sodium suppositories 12.5 mg the prescriber should know that these suppositories may be given to children up to 12 years of age for pain and inflanunations, and what may be the known side-effects and/or COTitra-indications. 

For the diclofenac sodium suppositories 12.5 mg, understandable information for the patient about how to use the product should be available, as well as information about the dosage, the desired effect and the possible side effects of the product etcetera. (However, be aware that this an example. In some cotmtries it is not permitted to claim a therapeutic effect for a pharmacy preparation, this being reserved for licensed products). 

For the diclofenac sodium suppositories 12.5 mg information may be obtained from international reference works or national formularies, with additional information on these characteristics. 

Diclofenac sodium is a well-known non-steroidal anti inflammatory active substance, widely described in literature. For the diclofenac sodium suppositories 12.5 mg good references will be available with regard to bioavail-abihty but also what is known from literature about the rectal availability of diclofenac sodium in general and what can be expected from the particular pharmacy preparation. 

Any experience with the use of diclofenac sodium suppositories 12.5 mg will be collected in this part of the file. 

For the diclofenac sodium suppositories 12.5 mg not only the choice of the composition (amounts and type of base or any other excipient) is explained, but also the quality requirements for the active substance and the excipients are described in this part. For the quality requirements reference may be made to the European Pharmacopoeia, both for the active substance and for the excipients. Also the size and quality of the suppository molds is described here. 

For the diclofenac sodium suppositories 12.5 mg the specifications of the product are outlined, together with information about the sources of these specifications. For the specification on the content of active substance may be referred to national laws, for a specification on the uniformity of dosage units referral may be made of the European Pharmacopoeia, but for the appearance own specifications may be used, for example no holes or cracks . 

For diclofenac sodium suppositories 12.5 mg it should be clear at least how sampling is performed, e.g. from the start, the middle and the end of preparation, and which parameters should be tested appearance, identity content, tmiformity of dosage units, disintegration. Also the frequency of testing is described, and preferably which analytical techniques are used. 

For diclofenac sodium suppositories 12.5 mg a description may be given of the choices that have been made concerning the production technique, the pouring temperature, the homogeneity, the way of sampling, the ranges for the batch size that have been chosen and how aU these have been tested. 

For diclofenac sodium suppositories 12.5 mg all results from stability tests that have been performed are given here, together with the considerations and conclusions that have led to the chosen storage period. 

N. M. Idkaidek, G. L. Amidon, D. E. Smith, N. M. Najib, and M. M. Hassan, Determination of the population pharmacokinetic parameters of sustained-release and enteric-coated oral formulations, and the suppository formulation of diclofenac sodium by simultaneous data fitting nsing NONMEM. Biopharm Drug Dispos 19 169-174 (1998). 

Ramakrishna, S. Fadnavis, N.W. Diwan, P.V. Comparative pharmacokinetic evaluation of compressed suppositories of diclofenac sodium in humans. Arzneimittelforschung, 1996, 46, 175-177... 

Here a copy of the batch preparation record of the diclofenac sodium 12.5 mg suppositories could be included in the product file. Additional information may be given to explain the reasons for the choice of the excipients, the melting temperature of the hard fat base, the choice of the preparation method, the determination of overages, and of the number of suppositories that are expected to be rejected during production, etcetera. 

Diclofenac is a phenylacetic acid derivative used mainly as sodium salt for the treatment of various pain and inflammation. Intramuscular injection occasionally causes tissue damage at the injection site. Suppositories may cause local irritation transient burning and stinging are reported when used for the eye and large doses can cause aplastic anemia.14... 

Diclofenac dates from the beginning of the 1970s, and was developed by Ciba-Geigy (now part of Novartis). It is marketed as its sodium or potassium salt in various formulations and dosage forms (injectable solutions, suppositories and capsules). 

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