Sivofenac SR 100 Diclofenac Potassium Tablets

SIVOFENAC-SR 100 TABLET
Diclofenac Potassium Tablets 100mg
For the use of registered medical practitioners & hospitals
 

DESCRIPTION

Diclofenac Potassium is a benzeneacetic acid derivative. The chemical name is 2-[(2,6- dichlorophenyl) amino] benzeneacetic acid, monopotassium salt. The molecular weight is 334.25. Its molecular form C14H10CI2NKO2.

 

LABEL CLAIM

Each film coated tablet contains:

Diclofenac Potassium BP 100mg

Excipients q.s

Colour: Erythrosine

 

MECHANISM OF ACTION (PHARMACODYNAMICS)

Diclofenac Potassium tablets contain the potassium salt of diclofenac, a non-steroidal compound with pronounced and clinically demonstrable analgesic, anti-inflammatory and anti-pyretic properties. Diclofenac is a potent inhibitor of prostaglandin biosynthesis and a modulator of arachidonic acid release and uptake.

 

PHARMACOKINETICS

Absorption

DicIofenac is 100% absorbed after oral administration compared to IV administration as measured by urine recovery. However due to first-pass metabolism, only about 50% of the absorbed dose is systemically available.

Distribution

The apparent volume of distribution (V/F) of Diclofenac Potassium is 1.3L/kg. Diclofenac is more than 99% bound to human serum proteins, primary to albumin.

Metabolism

Five diclofenac metabolites have been identified in human plasma and urine. The metabolites include 4’-hydroxy-, 5-hydroxy-, 3’-hydroxy-, 4’,5-dihydroxy- and 3’-hydroxy-4’-methoxy diclofenac.

Excretion

Diclofenac is eliminated through metabolism and subsequent urinary and biliary excretion of the glucuronide and the sulfate conjugates of the metaboiltes.

 

INDICATIONS

Diclofenac potassium tablets are indicated:

• For treatment of primary dysmenorrhea

• For relief of mild to moderate pain

• For relief of the signs and symptoms of osteoarthritis

• For relief of the signs and symptoms of rheumatoid arthritis

 

DOSAGE

For treatment of pain or primary dysmenorrhea the recommended dosage is 100mg
For the relief of osteoarthritis the recommended dosage is 100 to 150 mg/day in divided doses.

For the relief of rheumatoid arthritis the recommended dosage is 150 to 200 mg/day in divided doses.

 

CONTRAINDICATION

Diclofenac potassium tablets are contraindicated in patients with known hypersensitivity to diclofenac. Diclofenac potassium tablets should not be given to patients who have experienced asthma, urticaria, or other allergic type reactions.

 

DRUG INTERACTION

Aspirin

When Diclofenac Potassium immediate-release tablets are administered with aspirin, its protein binding is reduced.

 

PRECAUTION

Diclofenac potassium tablets cannot be expected to substitute for corticosteroids or to treat corticosteroid insufficiency. Abrupt discontinuation of corticosteroids may lead to disease exacerbation. Patients on prolonged corticosteroid therapy should have their therapy tapered slowly if a decision is made to discontinue corticosteroids.

 

WARNING

Pregnancy

In late pregnancy as with other NSAIDs, Diclofenac Potassium immediate-release tablets should be avoided because it may cause premature closure of the ductus arteriosus.

 

SIDE EFFECTS

Gastrointestinal experiences including: abdominal pain, constipation, diarrhea, dyspepsia, flatulence, gross bleeding/perforation, heartburn nausea, GI ulcers (gastric/duodenal) and vomiting. Abnormal renal function, anemia, dizziness, edema, elevated liver enzymes.

 

OVERDOSAGE

Symptoms following acute NSAID overdoses are usually limited to lethargy, drowsiness, nausea, vomiting, and epigastric pain, which are generally reversible with supportive care.

 

STORAGE INSTRUCTIONS

Store in a cool, dry and dark place.

KEEP OUT OF THE REACH OF CHILDREN

 

SHELF LIFE

The expiry date of the product is indicated on the label or Packaging or Carton.

 

NAFDAC Regn. No.: A4-8616

 

Manufactured in India by

Rhydburg PharmaceuticaIs Ltd.

C-2 & 3, S.I.E.L., Selaqui, Dehradun

Uttarakhand, INDIA
 

Manufactured for

Adpharm Pharmaceuticals Ltd.

60, Ajao Road Surulere, Lagos State,

Nigeria.

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