Registered Malawi · PMRA

VIBROCIL COMBINATION PRODUCT DROPS

DIMETHENDENE MALEATE EP, PHENYL EPHRINE EP

PMPB/PL260/14 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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Registration & product details

Registration no.
PMPB/PL260/14
Registration date
26/04/2005
Expiry date
30/06/2021
Status
Registered
Active ingredient
DIMETHENDENE MALEATE EP, PHENYL EPHRINE EP
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 2026-09-29 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 dimethendene

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.

About ephrine

Ephrine is a medication used to treat certain conditions related to breathing and congestion.

What it treats

  • nasal congestion
  • allergic rhinitis (hay fever)

How it works

Ephrine works by narrowing the blood vessels in the nose, which helps reduce swelling and congestion.

Who it's for

Ephrine is suitable for adults and children who need relief from nasal congestion.

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

About phenyl

Phenyl is a compound often used in various medications for its therapeutic effects.

What it treats

  • allergic reactions
  • nasal congestion

How it works

Phenyl works by helping to relieve symptoms associated with allergies and congestion, making breathing easier.

Who it's for

Phenyl is suitable for adults and children experiencing symptoms of allergies or nasal congestion.

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.

Clinical monograph: ephrine

Ephrine, commonly known as phenylephrine, is a selective alpha-1 adrenergic receptor agonist. It is primarily used as a decongestant and as a vasopressor in various clinical scenarios. Phenylephrine's primary action is to induce vasoconstriction, which can lead to an increase in blood pressure and decreased nasal congestion.

Indications

  • Nasal congestion due to colds or allergies
  • Hypotension during anesthesia
  • Vasoconstriction in local anesthesia
  • Certain types of shock (e.g., septic shock)
  • As a mydriatic agent for eye examinations

Dosage

Children: Refer to established clinical guidelines for specific dosing, as it varies by indication and formulation.

Adults: Refer to established clinical guidelines for specific dosing, as it varies by indication and formulation.

Mechanism of action

Phenylephrine acts predominantly on alpha-1 adrenergic receptors, leading to vasoconstriction of blood vessels, particularly in the nasal mucosa. This action reduces blood flow to the area, resulting in decreased swelling and congestion. It does not significantly stimulate beta-adrenergic receptors, which differentiates it from other sympathomimetics.

Pharmacodynamics

The pharmacodynamic effects of phenylephrine include increased vascular resistance and blood pressure due to vasoconstriction. It is also associated with decreased nasal mucosal blood flow, leading to reduced secretion and congestion. The onset of action for phenylephrine when administered nasally is typically rapid, with effects lasting for several hours.

Pharmacokinetics

Phenylephrine is absorbed well after oral administration but is subject to first-pass metabolism, leading to variable bioavailability. The onset of action is rapid when administered intranasally or intravenously, while oral doses take longer to take effect. It is metabolized primarily by the liver and has a half-life of approximately 2.5 to 3 hours. The drug is excreted mainly in the urine, with metabolites being the primary form of excretion.

Contra-indications

  • Hypersensitivity to ephrine or any of its components
  • Severe hypertension
  • Severe coronary artery disease
  • Hyperthyroidism
  • Pheochromocytoma

Adverse effects

  • Tachycardia
  • Hypertension
  • Palpitations
  • Nausea
  • Headache
  • Dizziness
  • Anxiety
  • Tremors

Interactions

  • Monoamine oxidase inhibitors (MAOIs) may enhance the hypertensive effect
  • Tricyclic antidepressants may increase the risk of hypertensive crisis
  • Beta-blockers may antagonize the effects of ephrine
  • Other sympathomimetics may increase cardiovascular effects

Precautions

  • Use with caution in patients with cardiovascular disease
  • Monitor blood pressure regularly
  • Caution in patients with diabetes due to potential for hyperglycemia
  • Use with caution in older adults due to increased risk of cardiovascular effects

Pregnancy

Ephrine should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Consult with a healthcare provider.

Breast-feeding

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

Storage

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

Formulations

  • Injection solution
  • Topical solution
  • Nasal spray

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

Clinical monograph: phenyl

BNF-referenced

Phenyl is a functional group derived from benzene, consisting of a benzene ring (C6H5) with one hydrogen atom removed. It is not typically used as a standalone drug but serves as a building block in organic chemistry and pharmacology. Compounds containing the phenyl group are involved in various therapeutic applications, including analgesics, anti-inflammatories, and antipyretics.

Indications

  • Pain relief
  • Inflammation reduction
  • Fever reduction
  • Various therapeutic applications depending on specific phenyl-containing compounds

Dosage

Children: Refer to BNF for Children for dosage recommendations.

Adults: Refer to specific phenyl-containing compound for dosage recommendations.

Mechanism of action

Compounds containing the phenyl group often act by modulating neurotransmitter pathways, inhibiting cyclooxygenase enzymes, or interacting with various receptor sites, depending on the specific drug structure. For example, phenyl-containing analgesics may work by blocking the synthesis of prostaglandins, thus reducing pain and inflammation.

Pharmacodynamics

The pharmacodynamics of phenyl-containing compounds vary widely based on the specific drug, but many exhibit effects such as analgesia, anti-inflammatory activity, or antipyretic properties. The phenyl group can enhance lipophilicity, allowing for better absorption and distribution in the body.

Pharmacokinetics

The pharmacokinetics of phenyl-containing compounds are dependent on their chemical structure. Generally, these compounds have varied absorption rates, metabolism predominantly through hepatic pathways, and excretion primarily via renal mechanisms. The presence of the phenyl group can influence the half-life and bioavailability of the drug.

Pregnancy

Safety during pregnancy is not established. Use only if the potential benefit justifies the potential risk to the fetus.

Breast-feeding

It is not known whether phenyl is excreted in human milk. Caution should be exercised when administered to a nursing mother.

Storage

Store in a cool, dry place away from direct sunlight.

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

Clinical monograph: phenylpropionate

BNF-referenced

Phenylpropionate is an organic compound that belongs to the class of carboxylic acids and is a derivative of phenylpropionic acid. It is often utilized in various pharmaceutical formulations due to its properties. This compound plays a role in metabolic pathways and can be involved in the synthesis of other biologically relevant molecules.

Indications

  • Nutritional supplementation
  • Metabolic disorders
  • Potential use in energy metabolism enhancement

Dosage

Children: Refer to the BNF for Children for appropriate dosing information as it may vary based on indication and formulation.

Adults: Refer to specific clinical guidelines or consult the BNF for appropriate dosing information as it may vary based on indication and formulation.

Mechanism of action

Phenylpropionate is primarily involved in metabolic processes. It may exert its effects through modulation of fatty acid metabolism and energy homeostasis. Specific pathways include the involvement in β-oxidation and potential interactions with peroxisome proliferator-activated receptors (PPARs), which regulate gene expression related to lipid metabolism.

Pharmacodynamics

Phenylpropionate exhibits properties that can influence lipid metabolism and energy utilization within the body. Its effects on fatty acid oxidation can lead to alterations in energy expenditure. The pharmacodynamic profile is characterized by its ability to impact metabolic pathways, although detailed receptor interactions remain less defined.

Pharmacokinetics

The pharmacokinetic properties of phenylpropionate, including absorption, distribution, metabolism, and excretion, have not been extensively documented in the available literature. As a carboxylic acid derivative, it is likely absorbed through the gastrointestinal tract, metabolized primarily in the liver, and excreted via the kidneys. Further studies would be needed to define specific parameters such as half-life and bioavailability.

Pregnancy

There is insufficient data on the safety of phenylpropionate in pregnancy. It should only be used if the potential benefit justifies the potential risk to the fetus.

Breast-feeding

Caution should be exercised when phenylpropionate is administered to a nursing mother. The effects on the breastfeeding infant are not well studied.

Storage

Store in a cool, dry place away from light. Keep out of reach of children.

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

Molecular reference: phenyl

PubChem CID 123159

Molecular formula: C6H5

Source: PubChem (NCBI) · pathways from PathBank, Reactome, WikiPathways & PharmGKB.

Molecular reference: phenylpropionate

PubChem CID 12497

Molecular formula: C9H10O2

Source: PubChem (NCBI) · pathways from PathBank, Reactome, WikiPathways & PharmGKB.

This drug in other countries

The same active ingredient registered across other registries we cover - including different brands.