Drug Interaction:
Concomittant intraarticular injections-
Do not coadminister with other intraarticular injectables.
Safety and efficacy has not been established
Indication:
U.S FDA APPROVED DRUGS FROM 01-01-08 TO 31-12-08
Drug name Indication Date of Approval
52. Hyaluronic acid salt 25mg 30-01-08
+ Cross-Linked Hyaluronic acid 25mg/ml
in prefilled syringe
For intradermal implantation and facial soft
tissue agumentation
Osteoarthiritis
Approved by (DCI) Drug Controller GENERAL - India For Marketing
(Ref- IDMA Publication)
Name of Drug Indication Date of Approval
Cross linked Hyaluronic acid 24mg+ 28-05-2010
Lidocaine 3mg prefilled syringe
For filling any medium sized depression of the skin via mid dermis injection
as well as for lipdefinition .
The presence of lignocaine is meant to reduce the patients pain during the
treatment
New drugs approved For Marketing by Drug Controller General of India(DCGI )
during the period January 1988 to November 2014
(Ref- IDMA Annual Publication 2015)
Name of Drug Indication Date of Approval
1.Hyaluronic acid (cross linked) 31-01-2009
prefilled syringe 18mg/0.6ml
and 24mg/0.8ml
For intradermal implantation and facial soft tissue augumentation
2.Hyaluronic acid salt 25mg 30-01-2008
+ cross linked hyaluronic acid 25mg/ml
in prefilled syringe
For intradermal implantation and facial soft tissue augumentation
3.Hyaluronic acid salt 31-03-2009
i Each 15gm tube contains :
Hyaluronic acid sodium salt 0.2gm/100gm
II Sterile gauze pads impregnated with cream:
Each gauze pad contains
Hyaluronic acid sodium salt 50/100mg
For the treatment of wound of different etiology
4. Hyaluronic acid sodium salt 0.2gm 31-03-2009
+ Silver sulfadiazine 1.0gm/25gm tube
Hyaluronic acid sodium salt 50mg
+ Silver sulphadiazine 1.0gm/100gm
gauze pads impregnated with cream
For the treatment of wound of diffrent etiology
Adverse Reaction:
Cardiovascular - blood pressure 3%
CNS - fatigue 1% pareesthesia 1%
GI - nausea 1%
Musculoskeletal - arthalgia 8% arthosis 1% back pain 5% joint disorder 1%
joint swelling 1% pain in limb 1% tendonitis 1%
Respiratory - rhinitis 3%
Miscellaneous - infection 1%
Contra-Indications:
Hypersensitivity to the drug
Special Precaution
Avian allergies- use caution in patients allergic to avian proteins, feathers, and egg products
Inflammed knee - safety and efficacy in severely inflammed knee joints have not been established
Inflammatory arthiritis- transcient increase in inflammation in infected knee following injections
with sodium hyaluronase have been reported in some patients with inflammatory arthiritis
( rheumatoid or gouty arthiritis )
Intraarticular administration- administer by intraarticular injection only.
Avoid intravascular , extra-articular , synovial tissue and capsule administeration.
Rare systemic adverse reactions reported
Safety and efficacy of intraarticular adminstration in locations other than the knee and for
conditions other than OA have not been established
Joint effusion- remove joint effusion before using hylanuronic acid derivatives.
Latex sensitivity - use caution in patients with a possible latex senstivity
Lymphatic or venous statis- use synvisc with caution when evidence of lymphatic or
venous or statis exists in treatment leg
Quarternary ammonium salts- avoid concomittant use of disinfectants for skin preparation
containing quarternary ammonium salts , such as benzyl ammonium chloride ,precipitation
of drug may occur.
Treatment cycle- the efficacy of a single treatment cycle of less than the recomended number
of injections has not been established. 3 injection are recommended. Safety and efficacy of
repeat cycles has not been established
Hypersensitivity reactions- anaphylactoid reactions have occured. All anaphylatic reactions
were classfied as mild to moderate
Pregnancy - safety and efficacy have not been established in pregnant women. Give to
pregnant woman only if needed
Lactation- excercise caution when administering to a breast feeding woman.
Children- safety and efficacy have not been established
Dosages/ Overdosage Etc:
Indication-
Osteoarthiritis
Dosage-
Administer 2mL (2.5 ml ) by intramuscular injection in affected knee once weekly for the
recommended number of injections per treatment cycle.
If the treatment is bilateral use a separate 2ml vial/syringe for each knee
Do not prepare injection site with skin disinfectant containing quaternary ammonium salts,
precipation of drug can occur.
Do not give intra-articular injectables concomittantly
Patient Information:
1. Inform patient that transcient pain and/or swelling of the treated joint may occur after injection
2. Inform patients to avoid strenous or prolonged ( more than 1 hour ) weight bearing activities
( eg jogging, tennis,) within 48 hours following treatment
3. Advice patients that the safety and efficacy of repeated treatments cycles have not been
studied
4. Avoid patients receiving synvisc that transceint effusion may occur. In some cases the
effusion may be considerable and cause pronounced pain. Advice patients to consult
with their health care providers if swelling is intensive.
Pregnancy and lactation:
Pregnancy -
Safety and efficacy have not been established in pregnant women. Give to
pregnant woman only if needed
Lactation-
Excercise caution when administering to a breast feeding woman.
Children-
Safety and efficacy have not been established