GMP Certified / Diclofenac Sodium Suppositories 25mg

• Customization: Available
• Quality Standard: Bp, USP
• Ctd Dossier: Ready
• Model NO.: suppository
• Documentation: Copp, COA
• Factory Certification: GMP
• Transport Package: Carton
• Specification: 25mg
• Trademark: Sinolead
• Origin: China
• Production Capacity: 100, 000, 000 Per Year

Product Description

Product Description

Generic Name	Diclofenac Sodium Suppositories
Strength	25 mg
Packing	10 suppositories /box
Origin	China

Value-added services:
 Packaging design by our team
 Registration service by our team
 Registration dossier available by our team
-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------

Product name:
Diclofenac Sodium Suppositories

Character:
This product is white or light yellow suppository.

Indications:
Anti-inflammatory and analgesic drugs. For rheumatoid arthritis, pain after surgery and fever due to various causes.

Adverse reactions:
Gastrointestinal reaction: mainly anal irritation symptoms, stomach discomfort, burning sensation, acid reflux, poor appetite, nausea, etc., can disappear after withdrawal or symptomatic treatment. A few of them can appear ulcer, bleeding, perforation;
Nervous system showed headache, dizziness, lethargy, excitement, etc.
Kidney caused edema, oliguria, electrolyte disorders and other serious renal adverse reactions;
Other rare liver enzyme transient elevation, very rare jaundice, rash, irregular heart rate, granulocytopenia, thrombocytopenia and so on are reversible.

Pharmacology and toxicology:
1. Pharmacological effect
This product is a derivative of isobutyfenic acid, its analgesic, anti-inflammatory and antipyretic effects than indomethacin 2 to 2.5 times stronger than 26 to 50 times stronger than aspirin. The analgesic and anti-inflammatory effects of this product are through the inhibition of epoxide and the reduction of prostaglandin, and the inhibition of lipoxygenase and the reduction of leukotrienes, bradykinin and other products.
2. Toxicological studies
The rats were given diclofenac sodium orally at 2mg/kg per day, and no increase in tumor incidence was found after long-term observation. In a two-year study of mice, a daily dose of 2mg/kg did not show any tumor predisposition. Various burst studies did not find that diclofenac sodium induced gene mutation. The rats were given 4mg/kg daily. Sterility was not observed in both sexes.
Acute toxicity test results: The oral LD50 of rats was 150mg/kg; Mice transoral 390mg/kg.

Storage:
Dark, sealed, stored below 30ºC.