Sitomni-M-OD 100/500: Notes for Doctors and Pharmacists
Sitomni-M-OD 100/500: Sitagliptin Phosphate & Metformin Hydrochloride Tablets
Practical notes for prescribers, pharmacists and distributors handling Sitomni-M-OD 100/500, covering Schedule G and H compliance, counselling, storage at the pharmacy and sourcing.
Product and regulatory summary
Sitomni-M-OD 100/500 is a film-coated tablet containing Sitagliptin Phosphate Monohydrate IP equivalent to Sitagliptin 100 mg with Metformin Hydrochloride IP 500 mg, supplied as 10 x 10 tablets and marketed in India by EMK Omni Pharma, Mysuru. The product is manufactured for the company at GMP-certified contract manufacturing units.
The pack carries the Schedule G and Schedule H statement: it is dangerous to take this preparation except under medical supervision, and it is not to be sold by retail without the prescription of a Registered Medical Practitioner.
The label also states that tablets should not be chewed or crushed, that dosage is as directed by the physician, that the product must be kept out of reach of children, and that metformin-containing medicines require periodic kidney-function monitoring as advised by the treating doctor.
Dispensing and Schedule H handling at the pharmacy
Standard retail practice applies:
- dispense only against a legible prescription from a registered medical practitioner, with the prescriber's name, registration details, date and signature
- retain the prescription or a copy as required, and maintain the Schedule H register entry with patient name, quantity supplied and date
- supply against a proper bill showing batch number, expiry and MRP
- do not substitute a different strength or a different molecular combination without referring back to the prescriber
- check the prescription against the patient's other medicines, particularly sulfonylureas, insulin, diuretics and any recently added agent that affects renal handling
- flag to the prescriber where the patient reports reduced kidney function, an upcoming contrast imaging study or planned surgery
A short note on the bill or a sticker on the carton reminding the patient to take the tablet with food often improves early tolerance.
Patient counselling checklist
Cover these points at the counter, briefly and in the patient's own language.
- Swallow whole with water, never chew, crush or split the film-coated tablet
- Take with or just after food to reduce metformin-related gastrointestinal effects
- Keep the same time each day, and do not double up after a missed dose
- Expected early effects: nausea, loose motions, metallic taste, usually settling in the first weeks
- Red flags needing prompt medical review: deep unexplained tiredness with muscle pain, laboured or rapid breathing, severe upper abdominal pain with vomiting, facial or lip swelling, severe persistent joint pain
- Hypoglycaemia awareness where a sulfonylurea or insulin is co-prescribed, including how to treat a low and to report every episode
- Sick days: contact the doctor if vomiting, diarrhoea or fever prevents normal eating and drinking
- Before scans and surgery: tell the radiology or surgical team about the metformin component
- Monitoring: keep to the schedule for HbA1c and renal function, and mention long-term vitamin B12 checks
- Storage at home: cool, dry, dark, away from bathroom humidity and out of reach of children
Storage and stock handling at the pharmacy
Store cartons in a cool, dry area, protected from direct light and away from external walls and windows where temperature swings are greatest. Air-conditioned or well-ventilated storage helps in Karnataka summers, and dehumidified space is worth considering through the monsoon.
Keep stock in the original cartons until dispensing, rotate on a first-expiry-first-out basis, and inspect strips for foil damage, discolouration or moisture marks before supply. Do not dispense from a cut strip where the batch number and expiry are no longer legible on the portion given to the patient.
Segregate near-expiry and returned stock clearly, and follow your usual documented process for expired-goods handling rather than returning them to the shelf.
Availability through EMK Omni Pharma
Pharmacies, clinics, hospitals, stockists and distributors can enquire about Sitomni-M-OD 100/500 and the wider Diabetes Care range, which also includes Sitomni-M 50/500, Gluomni M1 and Gluomni-M2, directly with EMK Omni Pharma.
Use the contact page on emkomnipharma.com, or reach the team on WhatsApp at +91 94487 74372, with your firm name, drug licence details, location and indicative requirement. Enquiries about pack availability, batch documentation and distribution territories are handled the same way.
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-OD 100/500 fall under?
- The pack carries both Schedule G and Schedule H warnings, so retail supply requires the prescription of a registered medical practitioner and the usual record keeping.
- Can a pharmacist substitute a different sitagliptin and metformin strength?
- No. Any change in strength or combination should be referred back to the prescriber, since the dose is matched to the patient's reports and co-medication.
- What counselling point is most often missed?
- Telling patients to mention the metformin component before contrast imaging or surgery, and giving clear sick-day advice for vomiting or diarrhoea.
- How should near-expiry stock be handled?
- Rotate on first-expiry-first-out, segregate near-expiry cartons from active stock, and follow your documented expired-goods process rather than reshelving.
- Does EMK Omni Pharma manufacture the product in-house?
- EMK Omni Pharma markets the brand in India. Manufacturing is carried out for the company at GMP-certified contract manufacturing units.
- How can a distributor start an enquiry?
- Through the contact page on emkomnipharma.com or on WhatsApp at +91 94487 74372, sharing firm name, drug licence details, location and indicative requirement.
Need Sitomni-M-OD 100/500 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.