Senadexin (Tablets) Instructions for Use
ATC Code
A06AB06 (Sennosides A and B)
Active Substance
Senna (BP British Pharmacopoeia)
Clinical-Pharmacological Group
Laxative drug that stimulates intestinal peristalsis
Pharmacotherapeutic Group
Drugs for the treatment of constipation; contact laxatives
Pharmacological Action
A laxative of plant origin. Senna leaves contain dianthrone glycosides (about 3%) – sennosides A, A1, B-G; a small amount of anthraquinone glycosides, including aloe-emodin and rhein 8-glycosides; about 10% mucilage; flavonoids, including kaempferol derivatives; naphthalene glycosides.
It stimulates peristalsis of the large intestine, causing a normal bowel movement 8-10 hours after administration. It acts selectively on the colon, restores normal bowel function, and does not affect digestion.
Indications
- Constipation due to hypotension and sluggish peristalsis of the large intestine.
- Regulation of bowel movements in hemorrhoids, proctitis, and anal fissures.
- Spastic and atonic constipation of various etiologies.
ICD codes
| ICD-10 code | Indication |
| K59.0 | Constipation |
| K60 | Fissure and fistula of anus and rectum |
| K62.8 | Other specified diseases of anus and rectum (including proctitis) |
| K64 | Hemorrhoids and perianal venous thrombosis |
| ICD-11 code | Indication |
| DB32.1 | Slow-transit constipation |
| DB50.Z | Fissure or fistula of anal region, unspecified |
| DB6Z | Hemorrhoids or perianal venous diseases, unspecified |
| DB70.Z | Infections of anal and rectal regions, unspecified |
| DB72.Z | Some specified diseases of the anal canal, unspecified |
| DD91.1 | Functional constipation |
| DE2Z | Diseases of the digestive system, unspecified |
| EG61 | Infections of the anus or perianal skin |
Dosage Regimen
| The method of application and dosage regimen for a specific drug depend on its form of release and other factors. The optimal dosage regimen is determined by the doctor. It is necessary to strictly adhere to the compliance of the dosage form of a specific drug with the indications for use and dosage regimen. |
Take orally in the evening after meals. The dose depends on the dosage form used.
For tablets, the specific dosage should be determined by a physician based on the patient’s condition and age. The effect typically occurs within 8-10 hours after administration.
Adverse Reactions
Possibleallergic reactions, abdominal pain, flatulence, and diarrhea.
With long-term use, the development of colitis and melanosis coli is possible. Prolonged use can lead to water-electrolyte imbalance and habituation, requiring dose escalation for effect.
Drug Interactions
Preparations reduce the absorption of tetracycline and other concurrently administered oral medications.
Concomitant use with thiazide diuretics, corticosteroids, or licorice root may increase the risk of hypokalemia. Monitor potassium levels with long-term concurrent use.
Contraindications
- Hypersensitivity to senna or any component of the formulation.
- Intestinal obstruction, abdominal pain of unknown origin, and acute inflammatory diseases of the abdominal organs.
- Severe water-electrolyte imbalance, dehydration, and gastrointestinal bleeding.
- Acute stage of proctitis, hemorrhoids, or strangulated hernia.
- Spastic constipation, cystitis, and uterine bleeding.
- Pregnancy, lactation, and childhood depending on the specific dosage form.
Overdose
Symptoms include severe abdominal pain, cramping, and profuse watery diarrhea, which may lead to fluid and electrolyte loss, hypokalemia, and dehydration.
Treatment is symptomatic and supportive. Ensure adequate fluid and electrolyte replacement. Discontinue use immediately. Do not administer anti-diarrheal medications.
Use in Pregnancy and Lactation
Contraindicated for use during pregnancy and lactation (breastfeeding).
Use in Hepatic Impairment
Use with caution in liver diseases.
Use in Renal Impairment
Use with caution in kidney diseases.
Pediatric Use
Use in children of appropriate age categories is possible strictly according to indications, in recommended doses and dosage forms. It is necessary to strictly follow the instructions in the drug leaflets regarding contraindications for the use of specific senna dosage forms in children of different ages.
Special Precautions
With long-term use of senna preparations, habituation may develop, so it is advisable to alternate them with other laxatives.
Storage Conditions
Store at 2°C (36°F) to 25°C (77°F). Keep in original packaging, protected from light. Keep out of reach of children.
Dispensing Status
Over-the-Counter
Important Safety Information
This information is for educational purposes only and does not replace professional medical advice. Always consult your doctor before use. Dosage and side effects may vary. Use only as prescribed.
Medical DisclaimerBrand (or Active Substance), Marketing Authorisation Holder, Dosage Form
Tablets 0.07 g: 20 or 30 pcs.
Marketing Authorization Holder
Vifitech, CJSC (Russia)
Dosage Form
| Senadexin | Tablets 0.07 g: 20 or 30 pcs. |
Dosage Form, Packaging, and Composition
Tablets from grayish-brown to brown in color with darker and lighter specks, round, flat-cylindrical in shape with a bevel and a score, with a faint characteristic odor.
| 1 tab. | |
| Sum of calcium salts of sennosides A and B from senna leaves calculated on dry substance 20% (senadexin)* | 0.07 g |
* the pharmaceutical substance, the sum of calcium salts of sennosides A and B (senadexin), is obtained from the medicinal plant raw material senna leaves: collected during the flowering and fruiting phase, dried and threshed leaves of wild and cultivated perennial shrubs of Cassia acutifolia Del. (C. senna L.) and Cassia angustifolia Vahl., family Fabaceae.
Excipients: corn starch – 0.1373 g, lactose monohydrate – 0.034 g, talc – 0.0049 g, calcium stearate – 0.002 g, magnesium stearate – 0.0015 g, vanillin – 0.0003 g.
10 pcs. – contour cell packs (2) – cardboard packs.
10 pcs. – contour cell packs (3) – cardboard packs.
Tablets 70 mg: 10 or 20 pcs.
Marketing Authorization Holder
Pharmaceutical Company Zdorovye, LLC (Ukraine)
Manufactured By
Pharmaceutical Company Zdorovye, LLC (Ukraine)
Quality Control Release
PHARMACEUTICAL COMPANY ZDOROVYE, LLC (Ukraine)
Or
KIROV PHARMACEUTICAL FACTORY, JSC (Russia)
Dosage Form
| Senadexin | Tablets 70 mg: 10 or 20 pcs. |
Dosage Form, Packaging, and Composition
Tablets from gray-brown to brown in color with specks of darker and lighter color, flat-cylindrical in shape, with a score and a bevel, with a vanillin odor.
| 1 tab. | |
| Calcium sennosides (as 20% calcium salts of sennosides A and B from senna leaves) | 70 mg |
Excipients: lactose monohydrate, potato starch, corn starch, vanillin, magnesium stearate, methylparahydroxybenzoate (nipagin), stearic acid, talc, microcrystalline cellulose, croscarmellose sodium.
10 pcs. – contour cell packs (1) – cardboard packs.
10 pcs. – contour cell packs (2) – cardboard packs.
