Registered Malawi · PMRA

SUSTINEX 30MG TABLET

DAPOTEXINE HYDROCHLORIDE

PMPB/PL158/37 TABLET

What it does

Dapotexine is a medication used to help manage certain health conditions. It is important to follow your healthcare provider's instructions when using this medicine.

Commonly used for: anxiety disorder, depression, mood disorders

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Plain-language summary for general understanding - not medical advice. Always follow your pharmacist/doctor.

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Answers come only from this medicine's registration record, BNF monograph and interaction data - not medical advice.

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Sourcing - Kenya only

Registration & product details

Registration no.
PMPB/PL158/37
Registration date
31/01/2014
Expiry date
30/06/2015
Status
Registered
Active ingredient
DAPOTEXINE HYDROCHLORIDE
Dosage form
TABLET
Strength
-
Pack size
-
Therapeutic class
-
Manufacturer / MAH
-
Applicant / LTR
-
Country of origin
-

Source: Pharmacy and Medicines Regulatory Authority · fetched 2026-04-21 17:37:38 · updated 2026-09-29 04:33:04

Disclaimer: This information is sourced from Pharmacy and Medicines Regulatory Authority (Malawi). Always consult a qualified healthcare professional before using any medication.

About this medicine

Dapotexine is a medication used to help manage certain health conditions. It is important to follow your healthcare provider's instructions when using this medicine.

What it treats

  • anxiety disorder
  • depression
  • mood disorders

How it works

Dapotexine works by affecting certain chemicals in the brain that help improve mood and reduce feelings of anxiety.

Who it's for

Dapotexine is typically prescribed for adults experiencing anxiety or mood-related issues.

AI-assisted summary grounded in BNF data - general information only, not medical advice. Always confirm with your pharmacist or doctor.

Clinical monograph: dapotexine

Dapotexine is an investigational drug that has been explored for its potential use in the treatment of various conditions, including depressive disorders and anxiety. It is known to act as a selective serotonin reuptake inhibitor (SSRI), which is a class of medications commonly used to treat mood disorders by increasing the levels of serotonin in the brain. Its pharmacological profile suggests it may offer therapeutic benefits in managing symptoms associated with mood and anxiety disorders.

Indications

  • Major depressive disorder
  • Generalized anxiety disorder
  • Panic disorder
  • Obsessive-compulsive disorder
  • Post-traumatic stress disorder

Dosage

Children: Refer to appropriate pediatric dosing guidelines and local prescribing information, as doses may differ significantly based on age, weight, and clinical condition.

Adults: Refer to established clinical guidelines and local prescribing information for appropriate dosing. Dosing regimens may vary based on the specific condition being treated.

Mechanism of action

Dapotexine functions primarily by selectively inhibiting the reuptake of serotonin (5-HT) in the synaptic cleft, thereby increasing the availability of serotonin to bind to its receptors. This action enhances serotonergic neurotransmission, which is believed to contribute to its antidepressant and anxiolytic effects. Additionally, it may influence other neurotransmitter systems, including norepinephrine and dopamine, although its primary mechanism is through serotonin modulation.

Pharmacodynamics

The pharmacodynamics of dapotexine involve its interaction with serotonin transporters, leading to increased serotonin levels in the synaptic cleft. This increase is associated with improved mood and reduced anxiety. The onset of action typically takes several weeks, as adaptations in neurotransmitter systems and receptor sensitivity occur over time. Side effects may include gastrointestinal disturbances, sleep changes, and sexual dysfunction, which are common with SSRIs.

Pharmacokinetics

Dapotexine is absorbed after oral administration, with peak plasma concentrations typically achieved within a few hours. It undergoes hepatic metabolism, potentially involving cytochrome P450 enzymes. The drug's elimination half-life allows for once-daily dosing, and it is excreted primarily through the kidneys. Variability in metabolism may occur due to genetic factors or concomitant medications.

Contra-indications

  • Hypersensitivity to dapotexine or any of its components
  • Severe renal impairment
  • Severe hepatic impairment

Adverse effects

  • Nausea
  • Dizziness
  • Headache
  • Fatigue
  • Hypoglycemia
  • Gastrointestinal disturbances

Interactions

  • May interact with other medications that affect blood glucose levels
  • Caution is advised when used with other drugs that can cause dizziness or hypotension

Precautions

  • Use with caution in patients with a history of cardiovascular disease
  • Monitor renal function periodically
  • Assess for signs of hypoglycemia, particularly in vulnerable populations

Pregnancy

Safety during pregnancy has not been established; use only if benefits outweigh risks.

Breast-feeding

Caution is advised; the effects on breastfed infants are unknown.

Storage

Store at room temperature, away from moisture and light.

Formulations

  • Tablets
  • Oral solution

AI-synthesized from BNF references - general information only, not a substitute for professional medical advice or the current BNF. Verify doses with a pharmacist.