Product image of Nalador (Sulprostone) supplied by GNH India

Nalador

Active Ingredient:
Sulprostone
Origin:
EU

Nalador (Sulprostone)

Sulprostone, the active ingredient in Nalador, is a prostaglandin E2 analog presented as an injectable solution for intravenous use. It is employed to stimulate uterine contractions and facilitate cervical ripening in obstetric care, and also has activity in gastric ulcer therapy.

GNH India supplies Nalador as a licensed, GDP‑compliant international pharmaceutical product to hospitals, pharmacies and clinics worldwide. The company adheres to stringent quality standards and provides regulatory support for cross‑border distribution. Customers benefit from reliable supply chains and responsive technical assistance.

Manufacturer / TM Owner

Teofarma S.R.L.

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Indications & Clinical Uses

Sulprostone is used in obstetric and gastrointestinal settings where prostaglandin E2 activity is required.

  • Induction of labor: facilitates uterine contractions to initiate delivery.
  • Cervical ripening: softens and dilates the cervix to prepare for labor.
  • Medical abortion: induces uterine activity to complete termination of early pregnancy.
  • Treatment of gastric ulcer: promotes mucosal protection and healing through prostaglandin pathways.

How It Works

  • Sulprostone acts as an agonist at prostaglandin E2 receptors EP1 and EP3 on uterine smooth muscle. Activation of these receptors increases intracellular calcium, producing strong uterine contractions and promoting cervical remodeling. In the gastrointestinal tract, EP receptor stimulation enhances mucosal blood flow and mucus secretion, supporting ulcer healing. The combined effect results in accelerated labor progression and protective gastric mucosal effects.

Side Effects

Sulprostone may be associated with several adverse reactions, ranging from mild to severe.

Common Side Effects

  • Nausea: feeling of sickness or urge to vomit.
  • Vomiting: expulsion of stomach contents.
  • Diarrhea: loose or watery stools.
  • Abdominal pain: discomfort in the stomach area.
  • Fever: elevated body temperature.
  • Headache: mild to moderate head pain.

Serious or Rare Side Effects

  • Severe uterine hyperstimulation: excessive contractions that may compromise fetal oxygenation.
  • Pulmonary edema: fluid accumulation in the lungs.
  • Allergic reaction: rash, itching, swelling, or anaphylaxis.
  • Hypotension: marked drop in blood pressure.
  • Cardiac arrhythmia: irregular heart rhythm.

Precautions & Warnings

When using Sulprostone, several precautions should be observed to ensure patient safety.

  • Assess uterine activity: monitor contraction frequency and intensity.
  • Evaluate fetal status: perform continuous fetal heart rate monitoring.
  • Review cardiovascular history: avoid use in patients with heart failure or uncontrolled hypertension.
  • Check for hypersensitivity: discontinue if allergic signs appear.
  • Avoid in active hemorrhage: risk of increased bleeding.
  • Store at 2-8°C: keep refrigerated, protect from light, do not freeze.

Avoid Interactions

Sulprostone can interact with other medicines, altering its efficacy or safety profile.

Major Interactions (Avoid)

  • Oxytocin: additive uterine stimulation may cause hyperstimulation.
  • Non‑steroidal anti‑inflammatory drugs (NSAIDs): may reduce prostaglandin synthesis and diminish effect.
  • Antihypertensive agents: increased risk of hypotension when combined with vasodilatory effects.

Moderate Interactions (Monitor Closely)

  • Magnesium sulfate: may potentiate uterine relaxation, counteracting Sulprostone.
  • Beta‑agonists (e.g., terbutaline): may diminish uterine contractile response.
  • Anticoagulants: heightened risk of bleeding due to uterine activity.

Frequently Asked Questions

Nalador contains sulprostone, which is employed as a uterotonic agent to induce labor, promote cervical ripening, and facilitate medical abortion. It is also used in the management of gastric ulcers to support mucosal healing.

Sulprostone activates prostaglandin E2 receptors EP1 and EP3 on uterine smooth muscle, raising intracellular calcium and causing strong contractions. In the gastrointestinal tract, it stimulates EP receptors to increase blood flow and mucus production, aiding ulcer repair.

The dose of Nalador is determined by the prescribing clinician based on the specific clinical situation, such as the stage of labor or the indication for use. No fixed regimen is provided here; the prescriber tailors the amount to the patient.

Nalador is used during pregnancy for labor induction and cervical ripening, but its safety category is listed as unknown. It should only be administered under close medical supervision. Use during breastfeeding is not recommended unless the benefit outweighs potential risk.

To order Nalador, submit an enquiry on the product page at gnhindia.com, specifying the required quantity. GNH India works with hospitals, pharmacies and procurement teams worldwide, verifies trade or institutional credentials, and then provides pricing, availability, shipping details and any required import documentation.

The primary alternative uterotonic is oxytocin, which acts via oxytocin receptors rather than prostaglandin pathways. Sulprostone may produce stronger uterine contractions and also offers cervical ripening, whereas oxytocin has a shorter half‑life and different side‑effect profile.

Nalador should be stored at 2‑8 °C, kept refrigerated, protected from light, and must not be frozen or shaken. Maintain the cold chain during transport and use the product within the expiry date indicated on the label.

Nalador is supplied as an injectable solution for intravenous administration. It is given by a qualified healthcare professional, typically as a controlled infusion or bolus, with monitoring of uterine activity and fetal status as appropriate.

Serious risks include uterine hyperstimulation leading to fetal distress, pulmonary edema, severe hypotension, and cardiac arrhythmias. Prompt recognition and management of these events are essential, and continuous monitoring is recommended during treatment.

Nalador is contraindicated in patients with known hypersensitivity to sulprostone, active uterine bleeding, severe cardiovascular disease, uncontrolled hypertension, or significant pulmonary disease. It should also be avoided in women with a history of adverse reactions to prostaglandin analogues.

Published by

GNH India Pharmaceuticals Limited

Licensed pharmaceutical supplier

Last updated:

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