Brand Information

Updated On: 27-02-2024

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NAC

Brand:
NAC

Manufacturer:
SYSTOPIC

Manufacturer Details
SYSTOPIC

Compositions:
Diclofenanc sodium 50mg tablets-, Diclofenanc sodium 75mg NAC SR tablets, Diclofenanc sodium 100mg NAC SR tablets, Diclofenanc sodium 75mg NAC AQ INJECTION,

Strength	Rate	Packing Style
50mg	15.50	10s tablets
75mg s.r	34.00	10s s.r Tablets- Nac S.R. 75
100mg s.r.	40.00	10s s.r tablets - Nac SR 100
75mg per ml	13.50	1 vial injection - Nac AQ injection

List of Related Indications:

Musculo-skeletal disorders -acute

List Of Drugs:

Diclofenac Sodium -Other derivatives@- ( FDC- List )( Jul 2007)

Indication Type Description:

Drug Interaction

Indication

Adverse Reaction

Contra-Indications

Dosages/ Overdosage Etc

Other Information

Patient Information

Pharmacology/ Pharmacokinetics

Interaction with Food

Pregnancy and lactation

Drug Interaction:

NSAIDs include-

Propionic acid- Fenoprofen, Flurbiprofen, Ibiprofen, Ketoprofen, Naproxen, Naproxen Sodium, Oxaprozin

Acetic acids- Diclofenac sodium, Etodolac, Indomethicin, Ketorolac, Nabumetone, Sulindac, Tolmetin Fenamates

(anthralic acids) - Meclofenamate, Mefenamic acxid Oxicams- Piroxicam

Refer- Ibuprofen

Increases blood levels of lithium and digoxin, Inhibits diuretics but potentiates potassium sparing diuretics. Increases toxicity of methotrexate. Lowers serum level concentration of salicylates.

Indication:

U.S. FDA APPROVED DRUGS FROM 01-01-08 TO 31-12-08

Drug name Indication Date of Approval

29. Diclofenac 50mg 24-01-08

+ Serratiopeptidase 10mg enteric coated tabs

For the treatment of acute pain in adults

38. Diclofenac sodium 50mg 28-01-08

+Dicyclomine HCL 20mg per ml injection

For the treatment of acute coliky pain in adults

57. Diclofenac sodium 50mg 30-01-08

Paracetamol 500mg

For the symptomatic treatment of acute pain

inflammation in patients with osteoarthiritis,

rheumatoid arthiritis and ankylosing spondylolitis

73.Diclofenac Sodium 100mg (SR Pellets) 31.01-08

+ Rabeprazole Sodium 20mg (EC Pellets)

Capsules

For treatment of painful inflamatory conditions

associated with gastroduodenal ulcers

144. Diclofenac Sodium 50mg 02-06-08

+ Codeine Phosphate 50mg tablets

For the treatment of adult patients with signs &

symptoms of acute painful conditions

228. Diclofenac 21-10-08

+ Thiocolochicolate (50mg EC+8mg)

Capsules

For the treatment of acute inflammation conditions

associated with spasm in adults only

270. Diclofenac 24-12-08

+ Thiocolchicoside (50mg+ 4mg)

Capsules

(Addl.lower Stgth)

U.S FDA APPROVED DRUGS DURING 2004

221. Diclofenac Transdermal patch 100mg/50cm2 10-08-2004

For Osteoarthiritis & soft tissue injury

244. Diclofenac Transedermal Patch 06-10-2004

(200mg/75cm2)

For pain relief

U.S FDA APPROVED DRUGS DURING 2006

23. Diclofenac Sodium 975/50mg) as EC + 28-02-2006

+ Misoprostol 200mcg

For OA & RA

U.S FDA APPROVED DRUGS DURING 2007

115. Diclofenac Sodium (75mg/ml) 30-07-07

injection(addl.stgth)

For management of painful conditions in

post-operative cases,rheumatoid arthiritis

and osteoarthiritis

Approved by (DCI) Drug Controller GENERAL - India For Marketing (Ref- IDMA Publication)

Name of Drug Indication Date of Approval

1.Diclofenac EC Tabs 25mg+ 31-05-2011

paracetamol 325mg capsule

Addl.stgth

Same as approved

2.Diclofenac colystyramine 145mg 25-02- 2013

Capsule corresponding to

Diclofenac sodium 75mg

Addl.:Indication

For the treatment of post-traumatic or post-operative swelling and

Inflammation

3.Diclofenac Diethylamine BP 4.64% 21-12-2012

w/v equiv. to Diclofenac sodium IP 4%

+ absolute alcohol IP 10% v/v topical solution

For the treatment of Acute lower back pain

4.Diclofenac Sodium Injecction 75mg/2ml 04-12-2012

For acute painful conditions in post operative pain , renal colic

and acute exacerbation of Gouty arthiritis

5. Diclofenac + Thiocolchicoside 24-12-2008

50mg+ 4mg Capsules

Addl. Lower stgth

6. Diclofenac + Thiocolchicoside 21-10-2008

50mg EC + 8mg capsules

For the treatment of acute inflammatory conditions associated

with spasms in adults only

7. Diclofenac 50mg + 16-03-2010

Chlorzoxazone 500mg tablets

For the treatment of acute inflammatory conditions associated

with spasms only

8.Diclofenac 50mg + 24-01-2008

Serratiopeptidase 10mg EC tablets

For the treatment of acute pain in adults

9. Diclofenac Colestyramine 145.6mg 19-05-2011

Corresponding to 75mg Diclofenac

Sodium capsules

For the treatment of acute arthiriris (including attacks of Gout),

chronic arthiitis especially Rheumatoid arthiritis ( chronic

polyarthiritis) ankylosing spondylosis ( Morbus Bechterew)

and other inflammatory , Rheumatoid syndromes of vertebral

column

10.Diclofenac Diethylamine BP 2.32% 01-01-2013

w/w eq. to diclofenac sodium 2%w/v+

Methyl salicylate IP 10% w/v +

Menthol IP 10% v/v topical solution

(Addl. stgth.)

For the treatment of acute lower back pain

11.Diclofenac diethylamine transdermal 04-12-2009

patch 100mg/37.5 sq.cm ( Addl.Stgth.)

Same as approved

12. Diclofenac Potassium 50mg + 08-04-2008

Serriatopeptidase (as EC pellets)

15mg Capsules

( Addl.Stgth.)

For the treatment of acute pain in adults

13.Diclofenac Sodium 75/50mg) as EC 28-02-2006

+ Misoprostol 200mcg

For OA & RA

14. Diclofenac Sodium SR 100mg+ 24-08-2011

Esperisone Hcl SR 150mg capsules

For the treatment of patient with acute musculoskeletal spasm

associated with low back pain

15. Diclofenac Sodium 75mg/ml 30-07-2007

injection ( Addl.Stgth.)

For the management of painful conditions in post-operative cases,

rheumatoid arthiritis and osteoarthiritis

16.Diclofenac Sodium 100mg SR pellets + 31-01-2008

Rabeprazole Sodium 20mg EC pellets

Capsules

For the treatment of painful inflammatory conditions associated

with Gastroduodenal ulcers

17.Diclofenac Sodium 50mg + 02-06-2008

Codeine Phosphate 50mg tablets

For the treatment of adult patients with signs and symptoms of

acute painful conditions

18. Diclofenac Sodium 50mg + 28-01-2008

Dicyclomine Hcl 20mg/ml of Injection

For the treatment of acute colicky pain in adults

19. Diclofenac Sodium 50mg + 30-01-2008

Paracetamol 500mg tablets

For the symptomatic treatment of acute pain and inflammation in

patients with osteoarthiritis, rheumatoid arthiritis and ankylosing

spondylitis

20. Diclofenac Sodium SR (two layered 20-12-2013

tablet) 150mg . Each tablet contains

Diclofenac Sodium IP 125mg Slow release

Diclofenac IP 25mg - Immediate release

( Addl.dosage Form)

For symptomatic treatment of pain and inflammation in irritation in

association with degenertive joint diasease / osteoarthiritis

21. Diclofenac Sodium SR tablet 150mg 26-03-2010

For the treatment of rheumatoid arthiritis, osteoarthiritis, ankylosing

spondilytis, Gout, Painful post operative pain, following Dental

surgery etc.

22. Diclofenac transdermal patch 6-10-2004

200mg/75 cm2

For pain relief

23. Diclofenac Sodium IP ( as SR pellets) 15-11-2011

100mg + Thiocolchicoside ( as SR pellets)

16mg capsule

( New Dosage Form)

For the treatment of acute inflammation conditions associated with

spasm in adult only

24. Diclofenac Sodium IP (ER granules) 06-01-2012

50mg + Eperisone HCl IP (tablet) 50mg

Hard gelatin capsules

( New Dosage Form)

For the treatment of patients with acute musculoskeletal spasm associated

with low back pain

FIXED DOSE COMBINATIONS APPROVED BY DCG(I)

FROM JANUARY 1961 TILL NOVEMBER 2014

Name of Drug Indication Date of Approval

1.Diclofenac 100mg EC+ 06-07-2010

Thiocolchicoside 8mg capsule

For secondary prophylaxis of ischemic herat disease in patients

where use of such combinations is appropiate

2. Diclofenac 50mg + 24-01-2008

Serratiopeptidase 10mg enteric coated tablets

For the treatment of acute pain in adults

3. Diclofenac Diethylamine 1.16% w/w eq. to 09-06-2008

Diclofenac Sodium 1%w/w+

Methyl Salicylate , Linseed Oil, Menthol)

For the treatment of acute painful condition

(Swelling and inflamation) due to musculoskeletal

disorder

4.Diclofenac Diethylamine BP 2.32 % eq. to 01-01-2013

Diclofenac Sodium 2.0% w/v +

Methyl salicylate IP 10.0% +

Menthol 5.0% w/v +

Absolute Alcohlol IP 10.0% v/v Topical Solution

(Addl.Sgth.)

For the treatment of Lower back Pain

5.Diclofenc Potassium 50mg + 08-04-2008

Serratiopeptidase (as enteric coated pellets)

15mg capsules

Addl.stgth

For the treatment of acute pain in adults

6. Doclofenac Sodium 1mg + 26-03-1999

Gentamycin Sodium 3mg/ml

Inflammation of the interior segmant of the eye where

there is a risk of bactrial occular infection

Indication

Rheumatoid arthritis

NSAIDs include-

Propionic acid- Fenoprofen, Flurbiprofen, Ibuprofen, Ketoprofen, Naproxen, Naproxen Sodium, Oxaprozin

Acetic acids- Diclofenac sodium, Etodolac, Indomethicin, Ketorolac, Nabumetone, Sulindac, Tolmetin

Fenamates (anthralic acids) - Meclofenamate, Mefenamic acxid

Oxicams- Piroxicam

Refer- Ibuprofen

Adverse Reaction:

Perforation of gastric ulcers,GIT haemorrhage,blood dyscrasias and anapylaxis(rare) GI disturbances, headache, dizziness, rash, pruritis, peripheral oedema.

GI bleeding. Peptic ulcer. Abnormalities of liver and kidney function.

Contra-Indications:

Peptic ulcer,hypersentivity to diclofenac in patients in whom diclofenac sodium, aspirin or other drugs with prostagladin synthetase inhibiting activity, may induce attacks of asthma or acute rhinitis.

Special precautions:

Patients with history of GI ulceration,hematemisis, impaired hepatic, cardiac or renal function, allergic reaction in patients with history of cardiac decompensation, hypotension and in pregnancy.

Dosages/ Overdosage Etc:

For the treatment of patients with acute musculoskeletal spasm associated

with low back pain

Indications:

Rheumatoid arthritis

Dosage:

Osteoarthritis - 100 to 159 mg/day in divided doses. Rheumatoid arthritis- 150 to 200 mg/day in divided dose.

Other Information:

For Availability/supplies

Contact -

1.Indian Drug Manufacturers Association (IDMA)

Phone- 022- 24944624/ 24974308

Fax- 022- 24950723

Email- idma@vsnl.com

Website: www.idma-assn.org

2.Bulk Drug Manufacturers Association (India)(BDMA)

Phone - 040-23703910/ 23706718

Fax- 040-23704804

Email- info@bdmai.org

Website: www.info@bdmai.org

Patient Information:

Refer- Ibuprofen

1. NSAIDs can cause discomfort and rarely more serious side effects such as GI bleeding which may result in hospitalisation and even fatalities.

2.Avoid aspirin and alcoholic beverages while taking medication.

3. If GI upset occurs, take with food, milk or antacids. For GI upset with tolmetin, use antacids other than sodium bicarbonate.

4. Notify physician, if skin rash, itching, visual disturbances, weight gain, edema occurs

5. Mefanamic acid and metclofenate: if rash, diarrhoea, or digestive problem occr discontinue use and consult physician

6. Ibuprofen- Do not take for more than 3 days for fever or 10 days for pain. If these symptoms persists,consult a physican.

Pharmacology/ Pharmacokinetics:

Refer NSAIDs- Ibuprofen

Interaction with Food:

Absorption delayed but not significant

Pregnancy and lactation:

Refer NSAIDs- Ibuprofen

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