Product image of Mysimba (Bupropion Hydrochloride, Naltrexone Hydrochloride) supplied by GNH India

Mysimba

Active Ingredient:
Bupropion Hydrochloride, Naltrexone Hydrochloride
Origin:
EU

Mysimba (Bupropion Hydrochloride, Naltrexone Hydrochloride)

Bupropion hydrochloride and naltrexone hydrochloride, the active ingredients in Mysimba, are a combined antiobesity agent presented as a combination tablet for oral use. It is indicated for the management of obesity and overweight in adults when used together with a reduced‑calorie diet and increased physical activity.

GNH India supplies Mysimba as a licensed, GDP‑compliant international pharmaceutical supplier serving hospitals, pharmacies and clinics worldwide. The company adheres to stringent quality standards and provides regulatory documentation for global distribution, including batch release certificates and stability data.

Manufacturer / TM Owner

Orexigen Therapeutics Ireland Limited

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Indications & Clinical Uses

Mysimba is used in the management of excess body weight and related metabolic conditions.

  • Obesity: helps achieve clinically significant weight loss when combined with diet and exercise.
  • Overweight with comorbidities: supports reduction of body weight and improvement of associated risk factors.
  • Weight management in adults: aids long‑term maintenance of reduced weight as part of a comprehensive lifestyle program.

How It Works

  • Mysimba combines bupropion, a norepinephrine‑dopamine reuptake inhibitor, with naltrexone, an opioid receptor antagonist. Bupropion stimulates pro‑opiomelanocortin (POMC) neurons in the hypothalamus, increasing the release of α‑melanocyte‑stimulating hormone, while naltrexone blocks the inhibitory feedback on these neurons. The synergistic activation of POMC pathways reduces appetite and enhances energy expenditure, leading to weight loss. This dual mechanism also modulates reward pathways and improves satiety signals, contributing to the overall anti‑obesity effect.

Side Effects

Mysimba may be associated with a range of adverse reactions, which are categorized by frequency.

Common Side Effects

  • Nausea
  • Headache
  • Dry mouth
  • Insomnia

Serious or Rare Side Effects

  • Seizures
  • Hypertension
  • Severe allergic reactions (anaphylaxis, angioedema)

Precautions & Warnings

When prescribing Mysimba, clinicians should consider several precautionary measures to ensure patient safety.

  • Cardiovascular assessment: evaluate blood pressure and heart disease before initiating therapy.
  • Seizure risk: avoid use in patients with a history of seizures or conditions lowering seizure threshold.
  • Psychiatric monitoring: watch for mood changes, depression, or suicidal ideation during treatment.
  • Concomitant medications: review all drugs for potential interactions, especially MAO inhibitors and opioid agonists.
  • Store at ambient temperature: keep in the original packaging, protect from moisture.

Avoid Interactions

Mysimba can interact with other medicines, requiring careful management of co‑administration.

Major Interactions (Avoid)

  • MAO inhibitors: risk of hypertensive crisis; must be discontinued at least 14 days before starting Mysimba.
  • Other bupropion‑containing products: increased risk of seizures.
  • Opioid agonists (e.g., morphine, oxycodone): naltrexone blocks analgesic effect, leading to loss of pain control.

Moderate Interactions (Monitor Closely)

  • CYP2B6 inhibitors or inducers (e.g., ritonavir, carbamazepine): may alter bupropion plasma levels.
  • Antihypertensive agents: additive blood pressure‑lowering effect may require dose adjustment.

Frequently Asked Questions

Mysimba is prescribed for the management of obesity and overweight in adults. It is intended to be used alongside a reduced‑calorie diet and increased physical activity to help patients achieve clinically meaningful weight loss and improve related health risk factors.

The combination pairs bupropion, which inhibits norepinephrine and dopamine reuptake, with naltrexone, an opioid receptor antagonist. Together they activate pro‑opiomelanocortin (POMC) neurons in the hypothalamus, enhancing satiety signals and increasing energy expenditure, which together promote weight loss.

The dosing regimen for Mysimba is individualized and set by a qualified prescriber. The physician will consider factors such as the patient’s weight, medical history, and response to therapy, and will titrate the dose according to approved prescribing information.

Safety data for Mysimba in pregnancy and lactation are limited. It should only be used if the potential benefit justifies the potential risk to the fetus or infant, and the decision should be made in consultation with a healthcare professional.

To place an enquiry, submit the required quantity on the Mysimba product page at gnhindia.com. GNH India supplies hospitals, pharmacies and procurement teams across international markets, verifies trade or institutional credentials, and then provides pricing, availability, shipping details and any necessary import documentation.

Mysimba’s dual mechanism of norepinephrine‑dopamine reuptake inhibition plus opioid antagonism differs from agents that act solely on appetite pathways, such as GLP‑1 analogues. This unique synergy can offer additional weight‑loss benefit for patients who have not responded adequately to single‑target therapies.

Mysimba tablets should be stored at ambient temperature, below 25 °C, in the original container to protect them from moisture and light. Keep the product out of reach of children and do not use after the expiry date printed on the packaging.

Mysimba is taken orally, usually once daily with food. The tablet is swallowed whole with a full glass of water. Patients should follow the titration schedule provided by their prescriber to minimize the risk of adverse effects.

The most serious risks include the potential for seizures, severe hypertension, and rare but life‑threatening allergic reactions such as anaphylaxis. Patients should be monitored closely for any signs of these events and seek immediate medical attention if they occur.

Mysimba is contraindicated in individuals with a current seizure disorder, uncontrolled hypertension, or those taking monoamine oxidase inhibitors (MAOIs). It should also be avoided in patients with known hypersensitivity to bupropion, naltrexone, or any of the tablet’s excipients.

Published by

GNH India Pharmaceuticals Limited

Licensed pharmaceutical supplier

Last updated:

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