Registered Malawi · PMRA

FENISTIL 1MG/ML DROPS

DIMETHENDENE MALEATE

PMPB/PL260/9 DROPS

What it does

Dimethendene is an antihistamine that helps relieve allergy symptoms.

Commonly used for: allergic reactions, hay fever (allergic rhinitis), itching, rash

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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/PL260/9
Registration date
26/04/2005
Expiry date
30/06/2018
Status
Registered
Active ingredient
DIMETHENDENE MALEATE
Dosage form
DROPS
Strength
-
Pack size
-
Therapeutic class
-
Manufacturer / MAH
-
Applicant / LTR
-
Country of origin
-

Source: Pharmacy and Medicines Regulatory Authority · fetched 2026-04-21 17:37:39 · updated 2026-09-19 04:30:22

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

Dimethendene is an antihistamine that helps relieve allergy symptoms.

What it treats

  • allergic reactions
  • hay fever (allergic rhinitis)
  • itching
  • rash

How it works

It blocks the action of histamine, a substance in the body that causes allergic symptoms.

Who it's for

This medicine is suitable for adults and children who are experiencing allergy-related symptoms.

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

Clinical monograph: dimethendene

Dimethendene is an antihistamine belonging to the first generation of H1 receptor antagonists. It is primarily used for the treatment of allergic conditions, including hay fever, allergic rhinitis, and urticaria. Due to its sedative effects, it is also used to alleviate symptoms of motion sickness and to induce sedation prior to surgical procedures.

Indications

  • Allergic rhinitis
  • Urticaria (hives)
  • Motion sickness
  • Sedation prior to surgical procedures

Dosage

Children: Refer to the BNF for Children for specific dosing information.

Adults: Refer to the BNF for specific dosing information.

Mechanism of action

Dimethendene exerts its effects by competitively inhibiting the action of histamine at the H1 receptor sites. This leads to a reduction in the physiological effects of histamine, such as vasodilation and increased permeability of blood vessels, which are responsible for allergic symptoms. Additionally, dimethendene has anticholinergic properties, which contribute to its effects in treating motion sickness.

Pharmacodynamics

As a first-generation antihistamine, dimethendene not only blocks H1 receptors but also crosses the blood-brain barrier, leading to central nervous system effects. These effects include sedation and potential impairment of cognitive function. The drug's efficacy in alleviating allergic symptoms is usually observed within 1 hour of administration, with a duration of action that can last several hours.

Pharmacokinetics

Dimethendene is absorbed rapidly from the gastrointestinal tract, with peak plasma concentrations occurring within 1 to 2 hours after oral administration. The drug is extensively metabolized in the liver, primarily through cytochrome P450 enzymes. Its metabolites are excreted via the urine. The elimination half-life of dimethendene is generally around 4 to 8 hours, but this can vary based on individual patient factors.

Contra-indications

  • Hypersensitivity to dimethendene or any components of the formulation
  • Severe liver impairment
  • Closed-angle glaucoma
  • Prostatic hypertrophy

Adverse effects

  • Drowsiness
  • Dry mouth
  • Dizziness
  • Nausea
  • Vomiting
  • Constipation
  • Blurred vision
  • Urinary retention

Interactions

  • CNS depressants (e.g., alcohol, benzodiazepines) may enhance sedative effects
  • Anticholinergic drugs may increase the risk of adverse effects
  • MAO inhibitors may intensify the effects of antihistamines

Precautions

  • Caution in patients with asthma or other respiratory conditions due to potential drying effects on respiratory secretions
  • Use with caution in the elderly due to increased susceptibility to side effects
  • Monitor for sedation in patients operating machinery or driving

Pregnancy

The safety of dimethendene in pregnancy has not been established. It should only be used if the benefits outweigh the risks.

Breast-feeding

It is not known whether dimethendene is excreted in human milk. Caution is advised when administering to nursing mothers.

Storage

Store at room temperature, away from moisture and heat. Keep out of reach of children.

Formulations

  • Tablets
  • Syrup
  • Injectable 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.