Source: Registered Drug Product Database (NG) Publisher: SHREE VENKATESH INTERNATIONAL LIMITED, Block No. 311, Kosamba Pardi Road, Village: Nandav, Taluka: Mangrol, Dist. Surat – 394125, Gujarat- INDIA
STOPINOR TABLET (Levonorgestrel Tablets BP 1.5 mg).
| Pharmaceutical Form |
|---|
|
Oral Solid Film coated tablets. |
Each Film Coated Tablet Contains:
Levonorgestrel BP 1.5 mg
Color: Lake Erythrosine, Lake Indigo carmine, & Titanium Dioxide BP
Excipients q.s.
| Sr. No | Ingredients | Spec. | Qty / tab (mg) | Batch Qty (kg) / 150000 Tablets | Reason for inclusion |
|---|---|---|---|---|---|
| 01 | Levonorgestrel | BP | 1.500 | 0.225 | API |
| 02 | Maize Starch | BP | 67.000 | 10.050 | Diluent |
| 03 | Lactose Monohydrate | BP/USP | 67.000 | 10.050 | Diluent |
| 04 | Iso-Propyl Alcohol | BP | 13.333 | 2.000 | Solvent |
| 05 | Dichloromethane/ Methylene Chloride | BP/USP | 36.670 | 5.500 | Solvent |
| 06 | Povidone K-30/ Polyvinylpyrrolidone K-30 | BP/USP | 4.200 | 0.630 | Binder |
| 07 | Colloidal Anhydrous Silica | BP/USP | 1.200 | 0.180 | Disintegrant |
| 08 | Purified Talc | BP/USP | 1.000 | 0.150 | Glidant |
| 09 | Magnesium Stearate | BP | 1.000 | 0.150 | Lubricant |
| 10 | Sodium Starch Glycolate | BP/USP | 1.450 | 0.218 | Disintegrant |
| 11 | Dichloromethane/ Methylene Chloride | BP/USP | 43.750 | 6.563 | Solvent |
| 12 | Iso-Propyl Alcohol | BP | 43.750 | 6.563 | Solvent |
| 13 | Hypromellose/ Hydroxypropyl Methylcellulose (E15) | BP/USP | 3.500 | 0.525 | Film forming |
| 14 | Macrogol 6000/ Polyethylene glycol 6000 | BP/USP | 0.380 | 0.057 | Lubricant |
| 15 | Titanium dioxide | BP/USP | 0.200 | 0.030 | Colorant |
| 16 | Purified Talc | BP/USP | 0.723 | 0.108 | Glidant |
| 17 | Erythrosine Lake | IH | 0.200 | 30.000 gm | Colorant |
| 18 | Indigo carmine Lake | IH | 0.002 | 0.300 gm | Colorant |
* 6.5% extra Maize Starch taken due to compensate of loss of drying
| Active Ingredient |
|---|
|
The precise mode of action of levonorgestrel as an emergency contraceptive is not known. At the recommended regimen, levonorgestrel is thought to work mainly by preventing ovulation and fertilisation if intercourse has taken place in the preovulatory phase, when the likelihood of fertilisation is the highest. |
| List of Excipients |
|---|
|
Maize starch |
Primary Packing: 1 tablets Alu/PVC Blister.
Secondary Packing: 1 such blisters packed in printed carton along with the pack insert.
SHREE VENKATESH INTERNATIONAL LIMITED, Block No. 311, Kosamba Pardi Road, Village: Nandav, Taluka: Mangrol, Dist. Surat – 394125, Gujarat- INDIA
| Drug | Countries | |
|---|---|---|
| STOPINOR | Nigeria |
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