VITADOX MELATONIN GUMMIES

Adverse effects

• Arthralgia
• Infection
• Dizziness
• Dry mouth
• Gastrointestinal discomfort
• Headaches
• Nausea
• Altered mood
• Night sweats
• Skin reactions
• Aggression
• Depression
• Disorientation
• Weight gain
• Electrolyte imbalance

Interactions

• Fluvoxamine: Severe (increases exposure)
• Givosiran: Moderate (increases exposure)
• Phenytoin: Unknown (decreases exposure)
• Axitinib: Unknown (increases exposure)
• Ritonavir: Unknown (decreases exposure)
• Leflunomide: Unknown (decreases exposure)
• Mexiletine: Unknown (increases exposure)
• Osilodrostat: Unknown (increases exposure)
• Rucaparib: Unknown (increases exposure)
• Teriflunomide: Unknown (decreases exposure)

Precautions

• Use with caution in hepatic impairment
• Use with caution in renal impairment
• Drowsiness may persist into the next day, affecting performance of skilled tasks such as driving

Pregnancy

No information available-avoid.

Breast-feeding

Present in milk-avoid.

Storage

Store in a cool, dry place away from light.

Formulations

• Modified-release tablets (Circadin®, Slenyto®)
• Immediate-release tablets (Adaflex®, Ceyesto®, Syncrodin®)
• Hard capsules
• Oral solution

Indications

• Condition A
• Condition B
• Condition C

Dosage

Children: Refer to the BNF for Children for specific dosing recommendations for paediatric patients.

Adults: Refer to the BNF for specific dosing recommendations for adults.

Mechanism of action

Action acts by inhibiting certain pathways involved in disease processes, which may include modulation of neurotransmitter activity or interference with cellular signaling mechanisms. Specific pathways and targets may vary based on the condition being treated.

Pharmacodynamics

The pharmacodynamics of Action involve its interaction with various receptors and enzymes, leading to alterations in physiological responses. These changes can result in therapeutic effects such as symptom relief or disease progression modification.

Pharmacokinetics

Action is absorbed through the gastrointestinal tract, with its bioavailability and peak plasma concentrations being influenced by food intake and other factors. It is metabolized primarily in the liver through cytochrome P450 enzymes, and its metabolites are excreted mainly via the kidneys.

Pregnancy

Use only if clearly needed, potential benefits must outweigh risks.

Breast-feeding

Caution is advised; excretion in human milk is unknown.

Storage

Store in a cool, dry place away from light.

Dosage

Children: Paediatric dosing for blends is not commonly standardized and should be approached with caution. Consultation with a healthcare provider is recommended to determine appropriate dosing based on the specific blend and the child's health needs.

Adults: Dosage for adult blends varies widely depending on the specific formulation and purpose. It is important to refer to the specific product label or consult a healthcare professional for guidance.

Mechanism of action

The mechanism of action for a blend depends on its individual components. For example, if the blend contains herbal extracts, each herb may have its own active compounds that interact with various biochemical pathways in the body, such as antioxidant activity, anti-inflammatory effects, or modulation of neurotransmitter levels. These mechanisms can vary significantly based on the specific herbs or substances included in the blend.

Pharmacodynamics

Pharmacodynamics of a blend involves understanding how the individual components affect the body. This can include synergistic effects where the combined action of substances leads to enhanced therapeutic effects, or antagonistic effects where one substance may reduce the efficacy of another. The overall pharmacodynamic profile will depend on the blend's composition and the dose of each ingredient.

Pharmacokinetics

Pharmacokinetics of a blend varies based on the components used. Factors such as absorption, distribution, metabolism, and excretion can change according to the specific substances involved. For instance, some herbal constituents may be rapidly absorbed, while others might have delayed onset of action due to slow metabolism or elimination processes. The presence of multiple ingredients may also influence the pharmacokinetics of each other through various interactions.

Pregnancy

Consult a healthcare provider before use. The effects on fetal development are not well-studied, and potential risks should be assessed based on the specific formulation and individual health circumstances.

Breast-feeding

Consult a healthcare provider before use. Safety during breastfeeding is not well-established, and potential risks to the infant should be considered.

Storage

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

Dosage

Children: Refer to specific drug information for dosing recommendations, as it varies by substance.

Adults: Refer to specific drug information for dosing recommendations, as it varies by substance.

Mechanism of action

The mechanism of action for a pure substance depends on the specific drug in question. Generally, pure drugs exert their effects by interacting with specific receptors or enzymes in the body, modulating biochemical pathways, or altering physiological functions. For instance, some pure drugs may act as agonists or antagonists at neurotransmitter receptors, while others may inhibit enzymes involved in metabolic processes.

Pharmacodynamics

Pharmacodynamics describes how a drug affects the body and involves the relationship between drug concentration and effect. Pure substances can exhibit a range of pharmacodynamic effects depending on their chemical structure and mechanism of action. The efficacy, potency, and therapeutic window of pure drugs are critical factors that influence their clinical use. Additionally, pure drugs may have dose-dependent effects, where increased concentrations lead to heightened responses or increased side effects.

Pharmacokinetics

Pharmacokinetics involves the absorption, distribution, metabolism, and excretion (ADME) of a drug. Pure substances may demonstrate distinct pharmacokinetic profiles based on their chemical properties. For example, lipophilic drugs may be rapidly absorbed through cell membranes, while hydrophilic drugs may require transport mechanisms. Metabolism often occurs in the liver, where pure drugs are converted to active or inactive metabolites. Excretion typically occurs through urine or bile, and the half-life of a pure drug can influence dosing frequency and treatment duration.

Pregnancy

There is limited data on the safety of this drug during pregnancy. Consult healthcare professionals for advice.

Breast-feeding

It is unknown whether this drug is excreted in human milk. Use with caution and consult healthcare professionals.

Storage

Store in a cool, dry place away from light. Follow specific storage instructions on the product label.

Indications

• Eczema
• Minor excoriations
• Wounds
• Hemorrhoids
• Sunburn prevention

Dosage

Children: Consult the BNF for Children for appropriate dosing information based on age and condition.

Adults: Apply to the affected area as needed, ensuring the skin is clean and dry before application. Refer to specific product guidelines for frequency.

Mechanism of action

Triple acts by providing a physical barrier to prevent skin irritation and help heal damaged skin. When inhaled, zinc oxide fumes can initiate pro-inflammatory responses in the lungs, leading to conditions such as metal fume fever by increasing pulmonary neutrophils and the release of tumor necrosis factor (TNF) and interleukins.

Pharmacodynamics

Zinc oxide exhibits astringent, soothing, and protective properties. Its topical applications are effective for various skin conditions, including eczema and minor wounds. The substance also has the ability to reflect ultraviolet radiation, making it useful in sunscreens and protection against sunburn.

Pharmacokinetics

Zinc oxide is minimally absorbed through the skin when used topically, thus its systemic effects are negligible. When inhaled, the fine particles can affect lung tissue but are typically of low concern when used as intended in topical formulations. The onset of local effects is rapid due to its barrier properties.

Adverse effects

• skin irritation
• allergic reactions
• respiratory distress if inhaled

Precautions

• Avoid inhalation of fumes, especially in poorly ventilated areas.
• Use with caution in patients with a history of allergies to zinc or other components.

Pregnancy

Zinc oxide is generally considered safe for use during pregnancy. However, it is advisable to consult a healthcare provider before use.

Breast-feeding

Zinc oxide is considered safe during breastfeeding, but it is recommended to consult a healthcare provider for individual cases.

Storage

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

Formulations

• topical creams
• ointments
• powders

Mechanism of action

Melatonin is a derivative of tryptophan. It binds to melatonin receptor type 1A, which then acts on adenylate cylcase and the inhibition of a cAMP signal transduction pathway. Melatonin not only inhibits adenylate cyclase, but it also activates phosphilpase C. This potentiates the release of arachidonate. By binding to melatonin receptors 1 and 2, the downstream signallling cascades have various effects in the body. The melatonin receptors are G protein-coupled receptors and are expressed in various tissues of the body. There are two subtypes of the receptor in humans, melatonin receptor 1 (MT1) and melatonin receptor 2 (MT2). Melatonin and melatonin receptor agonists, on market or in clinical trials, all bind to and activate both receptor types.The binding of the agonists to the receptors has been investigated for over two decades or since 1986. It is somewhat known, but still not fully understood. When melatonin receptor agonists bind to and activate their receptors it causes numerous physiological processes. MT1 receptors are expressed in many regions of the central nervous system (CNS): suprachiasmatic nucleus of the hypothalamus (SNC), hippocampus, substantia nigra, cerebellum, central dopaminergic pathways, ventral tegmental area and nucleus accumbens. MT1 is also expressed in the retina, ovary, testis, mammary gland, coronary circulation and aorta, gallbladder, liver, kidney, skin and the immune system. MT2 receptors are expressed mainly in the CNS, also in the lung, cardiac, coronary and aortic tissue, myometrium and granulosa cells, immune cells, duodenum and adipocytes. The binding of melatonin to melatonin receptors activates a few signaling pathways. MT1 receptor activation inhibits the adenylyl cyclase and its inhibition causes a rippling effect of non activation; starting with decreasing formation of cyclic adenosine monophosphate (cAMP), and then progressing to less protein kinase A (PKA) activity, which in turn hinders the phosphorilation of cAMP responsive element-binding protein (CREB binding protein) into P-CREB. MT1 receptors also activate phospholipase C (PLC), affect ion channels and regulate ion flux inside the cell. The binding of melatonin to MT2 receptors inhibits adenylyl cyclase which decreases the formation of cAMP.[4] As well it hinders guanylyl cyclase and therefore the forming of cyclic guanosine monophosphate (cGMP). Binding to MT2 receptors probably affects PLC which increases protein kinase C (PKC) activity. Activation of the receptor can lead to ion flux inside the cell. Melatonin is implicated in numerous physiological processes, including circadian rhythms, stress, and reproduction, many of which are mediated by the hypothalamus and pituitary. The physiological actions of melatonin are mainly mediated by melatonin receptors. /The authors/ describe the distribution of the melatonin receptor MT1 in the human hypothalamus and pituitary by immunocytochemistry. MT1 immunoreactivity showed a widespread pattern in the hypothalamus. In addition to the area of the suprachiasmatic nucleus (SCN), a number of novel sites, including the paraventricular nucleus (PVN), periventricular nucleus, supraoptic nucleus (SON), sexually dimorphic nucleus, the diagonal band of Broca, the nucleus basalis of Meynert, infundibular nucleus, ventromedial and dorsomedial nucleus, tuberomamillary nucleus, mamillary body, and paraventricular thalamic nucleus were observed to have neuronal MT1 receptor expression. No staining was observed in the nucleus tuberalis lateralis and bed nucleus of the stria terminalis. The MT1 receptor was colocalized with some vasopressin (AVP) neurons in the SCN, colocalized with some parvocellular and magnocellular AVP and oxytocine (OXT) neurons in the PVN and SON, and colocalized with some parvocellular corticotropin-releasing hormone (CRH) neurons in the PVN. In the pituitary, strong MT1 expression was observed in the pars tuberalis, while a weak staining was found in the posterior and ant

Pharmacodynamics

Melatonin is a hormone normally produced in the pineal gland and released into the blood. The essential amino acid L-tryptophan is a precursor in the synthesis of melatonin. It helps regulate sleep-wake cycles or the circadian rhythm. Production of melatonin is stimulated by darkness and inhibited by light. High levels of melatonin induce sleep and so consumption of the drug can be used to combat insomnia and jet lag. MT1 and MT2 receptors may be a target for the treatment of circadian and non circadian sleep disorders because of their differences in pharmacology and function within the SCN. SCN is responsible for maintaining the 24 hour cycle which regulates many different body functions ranging from sleep to immune functions

Mechanism of action

It acts by providing a physical barrier to prevent skin irritation and help heal damaged skin. ... Freshly formed fumes are ... composed of ... particles in range of 0.05 to 0.5 um, and ... /have/ increased activity when they come into contact with the alveolar walls of lung. As fumes age they become less reactive because they tend to agglomerate or form aggregates and settle out of atmosphere ... thereby reducing concn of reactive particulates in lung. ... The size of particles is important factor in producing the illness. ... Finely divided particles of metals /are/ so small that they behave much like a gas and act on the alveolar surfaces, affecting the lung tissue and not upper respiratory tract. /Zinc/ ... /That/ zinc oxide fume inhalation initiates a time-dependent sequence of proinflammatory events /was postulated/. This includes dose-dependent increases in pulmonary neutrophils and increased tumor necrosis factor (TNF) release into the pulmonary environment beginning at 3 hr after exposure, which, in turn, may lead to increases in bronchoalveolar lavage (BAL) IL-6 and the neutrophil chemoattractant IL-8. The IL-6 then enters the circulation, contributing to the development of the fever and the symptoms of metal-fume fever. /It was/ confirmed, through in vitro studies, that zinc oxide exposure stimulated U937 mononuclear cells to release TNF and IL-8, a finding consistent with in vivo observations in metal-fume fever. The pathogenesis /of metal fume fever/ is unknown, but it is thought to result from endogenous pyrogen release due to cell lysis. Extracts prepared from tracheal mucosa and from the lungs of animals with experimentally induced metal fume fever produce similar symptoms when injected into other animals. Diminish the penetration of ultraviolet (UV) light through the epidermis by absorbing UV radiation within a specific wavelength range. The amount and wavelength of UV radiation absorbed are affected by the molecular structure of the sunscreen agent. /Sunscreen agents/

Pharmacodynamics

Zinc oxide has astringent, soothing and protective properties and is used in topical preparations for eczema, slight excoriations, wounds and haemorrhoids. It also reflects ultraviolet radiation and can be used as a physical sunscreen.