Lofnac Suppository 2 x322x

GREENLIFE PHARMACEUTICALS LTD .

LOFNAC SUPPOSITORY Diclofenac Sodium 100mg

THE ALTERNATIVE ROUTE

DEFINITION  The term suppository comes from the latin word

which means ‘to place under’.  Suppositories are solid dosage forms intended for

istration of medicine into body orifices.

TYPES OF SUPPOSITORIES There are 3 types of suppositories  Rectal  Vagina  Urethral

SUPPOSITORY BASE  This could be classified into 2 types  (1)

Fatty bases -Cocoa butter -Synthetic triglycerides (cocoa butter -substitutes hydrogenated vegetable oils) e.g witepsol

Contd  (2) Water soluble and water miscible bases.

 -Glycerinated gelatin  -Polyethylene glycol bases (PEG)

THE FORMULATION  The medicament is incorporated into a base that

melts or dissolves at the body temperature.  Suppository base composition plays an important role in both the rate and extent of release of medications.  In the poly ethylene glycol base with the structure below

.  HOCH2(CH2-0-CH2)Nch20h  There is rapid release of the drug  Faster dissolution  It absorbs water.  It can be stored without refrigeration.  Dissolution time for polyethylene glycol Suppository

is 15-30 mins

CHARACTERISTICS OF AN IDEAL SUPPOSITORY  It should be non-toxic.  It should be physically stable i.e, during storage

and manufacture  It should be non-irritating  It should be chemically inert i.e, no colour change  Dissolve or disperse in rectal fluids  It should have high viscosity when dissolved ie, doesn’t leak from rectum or vagina

 It should be

hygroscopic  It should be convenient to handle  It should not bind with other molecules found inside the rectum

)

PHYSIOLOGY OF ABSORPTION  The rectum is highly vascularised  It consists of three main veins

Inferior haemorrhoidal vein Middle haemorrhoidal vein Superior haemorrhoidal vein

THE RECTUM

The blood supply to the anorectal region.

.  The middle and inferior veins have more blood

capillaries  When a suppository is inserted into the rectum, it is absorbed by the middle and inferior veins and transported via the ileum directly into the systemic circulation thereby bying the portal vein and first metabolism does not occur

.  When inserting, do not insert too deep into the

rectum as the drug will be absorbed by the superior veins, then to the portal vein.  The drug then es through first metabolism.

PHARMACOKINETICS OF PEG  Plasma concentrations obtained with PEG is greater

than that with cocoa butter, therefore PEG enhances the bioavailability of the drug than cocoa butter.

ADVANTAGES OF SUPPOSITORIES  Effective in cases of nausea and vomiting with oral

medication  Protect drug from harsh GI conditions  Portal circulation is byed, thereby side effect is reduced  Oral intake is restricted before surgery, suppository comes in useful  Self istration  Alternative route for drugs that are not palatable or have bitter taste

LOFNAC SUPPOSITORY  LOFNAC SUPPOSITORIES (diclofenac sodium

100mg). A non-steroidal anti inflammatory agent used in management of pains, t stiffness and inflammation

LOFNAC SUPPOSITORY Early post-operative relief of pain and shivering using diclofenac suppository versus intravenous pethidine in spinal anesthesia.

Ali Janpour Ebrahim et al( 2014): Journal of Anaesthesiology Clinical Pharmacology, vol 30: iss 2 Pg243-247

ABSTRACT Background: Pain and shivering are two challenging components in the post operative period. Many drugs were used for prevention and treatment of them. The aim of this study was to compare the effects of prophylactic prescription of diclofenac suppository versus intravenous (IV) pethidine in spinal anesthesia

METHOD  A multi-centered,prospective, double-blinded,

randomized clinical trial was conducted with a total of 180 patient scheduled for surgery under spinal anesthesia which include 60 patient in three groups.  Patient were randomly allocated to receive 100mg diclofenac sodium suppository or 30mg IV Pethidine or placebo

METHOD  Categorical and continuous variables were analyzed

by Chi-square, t-test, Mann-Whiteney and ANOVA or Kruskal-Wallis test

RESULTS  There was no statistical difference with regard to

patient characteristics and hemodynamics indices among the 3 groups. 15%, 16.65% and 40% in diclofenac, pethidine and control group respectively reported pain.  Prutitis was repetitive in pethidine group and was statistically significant (p=0.0036)

CONCLUSION A

single dose of sodium diclofenac suppository can provide satisfactory analgesia immediately after surgery and decrease shivering without remarkable complications.  This investigation highlights the role of preoperative istration of a single dose of rectal diclofenac as a sole analgesic for early post operative period.

Dosage and application • One suppository should be inserted daily into

the rectum. APPLICATIONS • Clean the area around the rectum. • Position the patient flat on back or on one side, with anal exposed.

Dosage and Application Cont • Remove wrapper by holding the suppository upright

and carefully peel the wrapper.

LOFNAC SUPPOSITORY • Gently insert well into the rectum. Use fingertips to

complete insertion. • Note: Avoid excessive handling as suppository melts

at body temperature.

LOFNAC SUPPOSITORY Indications • Post surgical pains • Rhematoid Arthritis • Osteoarthritis • Dysmenorrea • Ankylosing spondylitis • Pains and inflammation after injuries or minor surgeries.

LOFNAC SUPPOSITORY. Contra-indications: • Hypersensitivity to Diclofenac sodium • Gastric and/or duodenal ulcers

WHY YOU SHOULD PRSCRIBE SUPPOSITORIES  Useful when patient cannot swallow e.g in

   

unconscious patients, E.N.T patients and emergency cases Absorption is rapid Drugs avoid first metabolism in the liver Effective in cases of nausea and vomiting especially after surgery Reduce the pain of giving injection

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