Sitomni-M 50/500: Notes for Doctors and Pharmacists
Sitomni-M 50/500: Sitagliptin & Metformin Hydrochloride Tablets
Practical notes for prescribers, pharmacists and distributors handling Sitomni-M 50/500: Schedule G and H obligations, counselling points, pharmacy storage and sourcing from EMK Omni Pharma.
Product and Regulatory Summary
Sitomni-M 50/500 is presented as Sitagliptin and Metformin Hydrochloride Tablets containing Sitagliptin Phosphate IP equivalent to Sitagliptin 50 mg and Metformin Hydrochloride IP 500 mg, with approved excipients. It is a film-coated tablet supplied in a 10 x 10 pack and sits in the Diabetes Care category.
The pack carries the statement that it is a Schedule G and Schedule H prescription drug, with the caution that it is dangerous to take this preparation except under medical supervision and that it is not to be sold by retail without the prescription of a registered medical practitioner. It also carries the instruction to keep the medicine out of reach of children.
EMK Omni Pharma, Mysuru, markets the brand. Manufacture is undertaken at GMP-certified contract manufacturing units.
Dispensing and Schedule H Handling at the Counter
Retail pharmacies should apply the usual Schedule H discipline.
- Dispense only against a legible prescription from a registered medical practitioner, with the prescriber's name, registration number, date and signature
- Record the sale in the prescription register with patient name, prescriber details, quantity supplied and batch number
- Retain prescriptions or records for the period required under the Drugs and Cosmetics Rules
- Dispense in the original blister and carton wherever possible, so batch, expiry and MRP travel with the product
- Do not substitute strength or molecule at the counter; refer back to the prescriber
- Flag any concurrent sulfonylurea or insulin on the same prescription for the prescriber's confirmation, given the additive hypoglycaemia risk
- Check for repeat purchases at unusually short intervals, which may indicate dose confusion at home
Patient Counselling Checklist
A short structured conversation at the counter improves adherence more than a long leaflet.
- Timing and food: take with or immediately after a meal to reduce gastrointestinal effects; keep timing consistent
- Administration: swallow the film-coated tablet whole with water; do not crush or chew unless the prescriber advises it
- Early effects: nausea, loose motions, abdominal discomfort and metallic taste often settle within a few weeks
- Missed dose: take when remembered unless the next dose is near; never double up
- Hypoglycaemia: explain the symptoms and the need for fast-acting sugar, particularly if insulin or a sulfonylurea is co-prescribed
- Sick-day rule: advise contacting the prescriber during vomiting, diarrhoea, high fever or reduced fluid intake
- Imaging and surgery: instruct the patient to declare metformin use before contrast-enhanced imaging or planned procedures
- Alcohol: explain the risk associated with heavy intake
- Monitoring: reinforce periodic renal function, HbA1c and, in long-term use, vitamin B12 assessment
- Red flags: severe upper abdominal pain radiating to the back, or deep rapid breathing with severe weakness, warrants immediate medical attention
Storage and Stock Handling at the Pharmacy
The labelled condition is storage in a cool, dry and dark place below 25 degrees Celsius, protected from direct sunlight, heat and moisture.
- Keep a calibrated thermometer and, ideally, a humidity indicator in the dispensing area, and log readings during peak summer
- Avoid shelving stock against west-facing walls, near shutters, or under lighting that runs hot
- Maintain FEFO rotation so the shortest-dated stock moves first
- Inspect cartons at goods inward for crushing, moisture staining or broken seals, and verify batch, manufacturing date, expiry and MRP against the invoice
- Segregate and label near-expiry and expired stock immediately, and process returns per your distributor agreement
- Store away from strongly scented products and away from any area exposed to monsoon leakage or condensation
- Never dispense from a strip with damaged blister cavities or an illegible batch print
Availability Through EMK Omni Pharma
Sitomni-M 50/500 is available to pharmacies, clinics, hospitals and distributors through EMK Omni Pharma, Mysuru, Karnataka.
For stock enquiries, distribution and stockist appointments, product documentation or institutional supply discussions, reach the team through the contact page on the EMK Omni Pharma website, or on WhatsApp at +91 94487 74372.
When you write in, it helps to include your firm name, drug licence number, location, the pack quantity you are enquiring about and whether the requirement is for retail, hospital or institutional supply. Product-related queries from prescribers and pharmacists, including questions about presentation and pack details, are welcome through the same channels.
Adverse events observed in practice should be reported through the established pharmacovigilance route and may also be intimated to EMK Omni Pharma through the contact page. This article is for general information only and is not a substitute for advice from a registered medical practitioner.
Frequently asked questions
- What schedule does Sitomni-M 50/500 fall under?
- The pack carries a Schedule G and Schedule H prescription drug warning, so it must not be sold by retail without the prescription of a registered medical practitioner.
- What counselling point is most often missed at the counter?
- The sick-day rule. Patients frequently continue metformin-containing tablets through vomiting, diarrhoea or fever, when they should be contacting the prescriber.
- How should a pharmacy store this product during the monsoon?
- Below 25 degrees Celsius in a dry, shaded area away from leakage and condensation, with humidity monitored and stock rotated on a first-expiry-first-out basis.
- Can a pharmacist substitute a different strength if 50/500 is out of stock?
- No. Strength changes affect both molecules and depend on renal function and current control. Refer the patient back to the prescriber.
- How can a distributor or hospital source Sitomni-M 50/500?
- Contact EMK Omni Pharma through the contact page on the website or on WhatsApp at +91 94487 74372, with firm name, drug licence number, location and requirement.
- What should be verified at goods inward?
- Batch number, manufacturing date, expiry date and MRP against the invoice, plus carton integrity, intact blister seals and no signs of moisture or heat exposure.
Need Sitomni-M 50/500 for your pharmacy, hospital or clinic?
EMK Omni Pharma supplies through authorised channels across Karnataka. Send an enquiry and our team will respond during business hours.
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Medical Disclaimer
This product information is intended for general awareness only and should not be considered medical advice. Please consult a registered medical practitioner before using any prescription medicine.