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Monuril Granules

NAFDAC Reg.-Nr. B4-4173 Medikament

Registriert bei NAFDAC. Registrierung aktivAs of 1 November 2026 · synced automatically from official sources.
Produkt-
Monuril Granules
NAFDAC-Nummer
B4-4173
Wirkstoff
Fosfomycin Trometamol
Stärke
3 g
Form
Granules for solution
VPE:
3 g x 1's (in sachet)
Hersteller
Nicht aufgeführt
Applicant (holder)
Phillips Pharmaceuticals (Nigeria) Limited
Approved
25 Sep 2024
Status
Active View on NAFDAC ↗
Registration valid to
24 Sep 2029
WER WARNT
None found
Community reports
None
Times checked
0

About the medicine: Fosfomycin trometamol: uses, dosage and brands worldwide

What we found

  • Monuril Granules is on the NAFDAC register with an active registration (B4-4173). A valid number alone does not prove a pack is genuine — counterfeiters copy real numbers, so also check the expiry date, seal and print quality.

Generated automatically from the NAFDAC register, WHO alerts and community data as of today. This is not medical advice. Always follow your doctor or pharmacist.

How to use Monuril Granules

What the official label says. If a doctor prescribed it, follow the prescription. Your pack's leaflet comes first if it is different.

Who it is for

Tromethamine Injection is indicated for the prevention and correction of metabolic acidosis. In the following conditions it may help to sustain vital functions and thus provide time for treatment of the primary disease: Metabolic Acidosis Associated with Cardiac Bypass Surgery. Tromethamine Injection has been found to be primarily beneficial in correcting metabolic acidosis which may occur during or immediately following cardiac bypass surgical procedures. Correction of Acidity of ACD Blood in Cardiac Bypass Surgery. It is well known that ACD blood is acidic and becomes more acidic on storage. Tromethamine effectively corrects this acidity. …

How to take it and how often
  • Tromethamine Injection is administered by slow intravenous infusion, by addition to pump-oxygenator ACD blood or other priming fluid or by injection into the ventricular cavity during cardiac arrest
  • For infusion by peripheral vein, a large needle should be used in the largest antecubital vein or an indwelling catheter placed in a large vein of an elevated limb to minimize chemical irritation of the alkaline solution during infusion
  • Catheters are recommended
  • Dosage and rate of administration should be carefully supervised to avoid overtreatment (alkalosis)
  • Pretreatment and subsequent determinations of blood values (e.g. pH, PCO 2 , PO 2 , glucose and electrolytes) and urinary output should be made as necessary to monitor dosage and progress of treatment
  • In general, dosage should be limited to an amount sufficient to increase blood pH to normal limits (7.35 to 7.45) and to correct acid-base derangements
  • The total quantity to be administered during the period of illness will depend upon the severity and progression of the acidosis
  • The possibility of some retention of tromethamine, especially in patients with impaired renal function, should be kept in mind
  • The intravenous dosage of Tromethamine Injection may be estimated from the buffer base deficit of the extracellular fluid in mEq/liter determined by means of the Siggaard-Andersen nomogram. …
Talk to a doctor first if
  • Tromethamine Injection is contraindicated in uremia and anuria
  • In neonates it is also contraindicated in chronic respiratory acidosis and salicylate intoxication
Warnings

Large doses of Tromethamine Injection may depress ventilation, as a result of increased blood pH and reduced CO 2 concentration. Thus, dosage should be adjusted so that blood pH is not allowed to increase above normal. In situations in which respiratory acidosis may be present concomitantly with metabolic acidosis, the drug may be used with mechanical assistance to ventilation. Care must be exercised to prevent perivascular infiltration since this can cause inflammation, necrosis and sloughing of tissue. …

Possible side effects

Generally, side effects have been infrequent. Respiratory: Although the incidence of ventilatory depression is low, it is important to keep in mind that such depression may occur. Respiratory depression may be more likely to occur in patients who have chronic hypoventilation or those who have been treated with drugs which depress respiration. In patients with associated respiratory acidosis, tromethamine should be administered with mechanical assistance to ventilation. Vascular: Extreme care should be taken to avoid perivascular infiltration. Local tissue damage and subsequent sloughing may occur if extravasation occurs. Chemical phlebitis and venospasm also have been reported. …

If you take too much

Too rapid administration and/or excessive amounts of tromethamine may cause alkalosis, hypoglycemia, overhydration or solute overload. In the event of overdosage, discontinue the infusion, evaluate the patient and institute appropriate countermeasures. (See WARNINGS , PRECAUTIONS and ADVERSE REACTIONS ). The LD 50 values for the acute intravenous toxicity of Tromethamine Injection are influenced by the rate of infusion of the dose administered. Intravenous LD 50 Mice = 3,500 mg/kg Intravenous LD 50 Rats = 2,300 mg/kg

If you miss a dose

Take it when you remember, unless it is nearly time for the next dose. Then skip the missed one. Never take two doses at once to make up for it. Check your leaflet, as some medicines are different.

From the official U.S. FDA label for this active ingredient. Your pack may have a different strength, so always read its leaflet. If a doctor prescribed it, follow the prescription. Ask a pharmacist if you are unsure. Label dated 2026-01-07.

Label for fosfomycin trometamol, the active ingredient registered with NAFDAC.

Check your pack of Monuril Granules

Add the expiry date on your pack for a full Trust Score.

Or take photos of the pack
3 free checks left today Official sources: U.S. FDA · EMA (EU) · NAFDAC · WHO alerts

About Monuril Granules

What is in Monuril Granules?

Monuril Granules contains Fosfomycin Trometamol (3 g), as granules for solution, according to its NAFDAC registration record.

Is Monuril Granules registered with NAFDAC?

Yes. Monuril Granules is listed on the NAFDAC register under registration number B4-4173, and its registration is active as of 1 November 2026.

Has Monuril Granules been flagged as fake or recalled?

No WHO falsified or substandard medical product alert currently matches Monuril Granules in our automatically synced alert list.

How can I check that my pack of Monuril Granules is genuine?

Run a free authenticity scan with the NAFDAC number B4-4173, your pack's expiry date and batch number to get a Trust Score, compare the pack with the NAFDAC record (ingredient, strength, form, manufacturer), and buy only from licensed pharmacies.

How do I take Monuril Granules?

Follow your prescription or the leaflet in your pack. The official label says: Tromethamine Injection is administered by slow intravenous infusion, by addition to pump-oxygenator ACD blood or other priming fluid or by injection into the ventricular cavity during cardiac arrest. For infusion by peripheral vein, a large needle should be used in the largest antecubital vein or an indwelling catheter placed in a large vein of an elevated limb to minimize chem…

What is Monuril Granules used for?

Tromethamine Injection is indicated for the prevention and correction of metabolic acidosis. In the following conditions it may help to sustain vital functions and thus provide time for treatment of the primary disease: Metabolic Acidosis Associated with Cardiac Bypass Surgery. Tromethamine Injection has been found to be primarily beneficial in correcting metabolic acidosis which may occur during (Summarised from the official U.S. FDA label for fosfomycin trometamol. Always follow your doctor or pharmacist.)

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