Vitafol5 ml

Vitafol is a combination antihypoxant/metabolic-support preparation used mainly as an adjunctive treatment in conditions associated with tissue hypoxia and impaired cellular energy metabolism. It is not a first-line or curative therapy and does not replace standard emergency or disease-specific treatment.

Established/adjunctive uses

• Adjunct (add-on) therapy, together with standard treatment, in acute ischemic stroke and other acute cerebral ischemic/hypoxic events, to support cellular energy metabolism during the recovery phase.
• Adjunct in post-hypoxic and toxic/metabolic encephalopathy, to support tissue oxygen utilisation.
• Adjunct in chronic cerebrovascular insufficiency and recovery after cerebral ischemic injury, as part of a broader treatment plan directed by a physician.

Uses requiring combination therapy / limited evidence

• Used in some markets as supportive/metabolic therapy for conditions of tissue hypoxia (e.g., following surgery, in intensive care settings), always alongside standard disease-specific management.

Note: The evidence base for this specific four-component combination is limited and varies by region compared with conventional, guideline-directed therapies. It should be used only as directed by a physician and only as an adjunct, never as a substitute for standard emergency treatment of acute ischemic events.

Sodium Succinate + Cytochrome C + Adenosine + Nicotinamide is a fixed combination of four active substances that support cellular energy (mitochondrial) metabolism:

• Sodium succinate - a salt of succinic acid, an intermediate of the citric acid (Krebs) cycle.
• Cytochrome C - a protein component of the mitochondrial electron transport chain.
• Adenosine - a naturally occurring purine nucleoside involved in cellular energy (ATP) metabolism.
• Nicotinamide - the amide form of vitamin B3 (niacin), a precursor of NAD+/NADH.

Exact strengths per ampoule/vial or dosage unit vary by manufacturer and formulation; always check the specific product label/pack insert for the precise composition of Sodium Succinate + Cytochrome C + Adenosine + Nicotinamide being dispensed.

Vitafol is a multi-component metabolic/antihypoxant preparation, typically given by injection, that combines a Krebs-cycle intermediate (succinate), an electron-transport-chain protein (cytochrome C), a purine nucleoside (adenosine) and a vitamin B3 derivative (nicotinamide). Together, these components are intended to support cellular energy production and reduce oxidative stress in tissues exposed to hypoxia or ischemia. It is marketed in certain regions as adjunctive therapy for conditions involving tissue hypoxia, and is used alongside - never instead of - standard, guideline-directed treatment.

Vitafol belongs to the Antihypoxant / Cellular Metabolic and Antioxidant Support Combination therapeutic class.

The components of Sodium Succinate + Cytochrome C + Adenosine + Nicotinamide act together to support mitochondrial energy metabolism under conditions of reduced oxygen supply:

• Sodium succinate is oxidised via succinate dehydrogenase in the Krebs cycle and can support ATP generation through the electron transport chain even when oxidative phosphorylation is impaired by hypoxia.
• Cytochrome C is a key electron carrier between Complex III and Complex IV of the mitochondrial respiratory chain; supplementation is proposed to help restore electron transport and cellular respiration in hypoxic/ischaemic tissue.
• Adenosine contributes to resynthesis of ATP/ADP pools, has vasodilatory properties in vascular tissue, and is believed to exert cytoprotective effects during ischaemia-reperfusion.
• Nicotinamide is a precursor of NAD+/NADH, cofactors required for numerous oxidation-reduction reactions in cellular respiration and energy metabolism, and has antioxidant-supportive properties.

The overall pharmacodynamic rationale is to enhance cellular tolerance to hypoxia/ischaemia and to limit oxidative injury; clinical outcome data for this specific four-component combination are more limited than for standard first-line therapies.

Pharmacokinetics

Detailed pharmacokinetic data (absorption, distribution, metabolism, elimination) for the fixed combination as a whole are not well characterised in international literature. Individual components (succinate, adenosine, nicotinamide) are endogenous or near-endogenous metabolites with short biological half-lives; cytochrome C, as a protein, is expected to be metabolised via proteolysis.

Vitafol is generally administered by slow intravenous infusion after dilution in a compatible infusion fluid (e.g., 0.9% sodium chloride or 5% dextrose), as specified on the product label; rapid intravenous injection (bolus) is generally avoided due to the risk of flushing, hypotension, and bradycardia related to the adenosine component.

• Administer only under medical supervision, typically in a hospital/clinic setting where vital signs (heart rate, blood pressure) can be monitored, particularly during the first infusion.
• Because cytochrome C is a protein of animal origin, some prescribers use a small test dose before the first full administration to check for hypersensitivity (see Precautions and Warnings).
• Do not mix with other medicines in the same syringe/infusion bag unless compatibility has been confirmed.
• Discard any unused solution remaining after a single use; do not reuse opened ampoules.

Vitafol has the following clinically relevant interactions, related mainly to its adenosine and nicotinamide components:

• Methylxanthines (caffeine, theophylline, aminophylline): these competitively antagonise adenosine receptors and may reduce the intended effect of the adenosine component.
• Dipyridamole: inhibits cellular reuptake of adenosine and can potentiate its effects (increased risk of hypotension, flushing, bradycardia); avoid or use with extra caution and monitoring.
• Drugs that slow cardiac conduction (e.g., digoxin, verapamil, diltiazem, beta-blockers): concurrent use with the adenosine component may increase the risk of bradycardia or atrioventricular block; monitor cardiac status closely.
• Carbamazepine: nicotinamide can inhibit carbamazepine metabolism, raising carbamazepine plasma levels and the risk of carbamazepine toxicity; dose adjustment and monitoring may be needed if co-administered.

Tell your physician about all other medicines, supplements, and herbal products you are taking before starting Vitafol.

Reported side effects of Vitafol include:

Common

• Transient flushing, warmth, or a feeling of heat, mainly related to the adenosine component
• Injection/infusion-site discomfort, redness, or irritation
• Headache
• Nausea or mild gastrointestinal discomfort
• Transient changes in blood pressure or heart rate (e.g., mild hypotension or bradycardia) during infusion

Less common/serious

• Hypersensitivity reactions, including skin rash, itching, or, rarely, anaphylactoid/anaphylactic reactions - cytochrome C is a protein of animal origin and carries a recognised risk of allergic reaction (see Precautions and Warnings)
• Significant bradycardia or transient atrioventricular conduction disturbance, usually self-limited given the short duration of action of adenosine

Contact your physician promptly if you notice breathing difficulty, swelling of the face/throat, severe dizziness, chest pain, or a marked change in heart rate after receiving Vitafol.

Data on the use of Vitafol in human pregnancy and lactation are limited. As a precaution, it should be used in pregnancy only if clearly needed and if the potential benefit is judged by the treating physician to outweigh the potential risk to the fetus; it is not recommended for routine use in pregnancy. Similarly, use during breastfeeding should occur only on medical advice, weighing the benefit to the mother against any possible risk to the nursing infant, since it is not known whether the components (or their metabolites) pass into breast milk in clinically significant amounts. Always consult a physician before use in pregnancy or while breastfeeding.

Before using Vitafol, discuss the following with your physician:

• Hypersensitivity/anaphylaxis risk: because cytochrome C is derived from animal tissue, it can act as a foreign protein and provoke allergic or anaphylactoid reactions; a test dose may be used before the first full dose, and the infusion should be given where reactions can be promptly managed.
• Cardiac conduction disorders: use with caution in patients with pre-existing bradyarrhythmia, sick sinus syndrome, or high-grade atrioventricular block, because of the adenosine component's effects on cardiac conduction; monitor heart rate/rhythm during administration.
• Gout/hyperuricaemia: the adenosine (purine) component may modestly raise uric acid turnover; use with caution and monitor in patients with a history of gout or hyperuricaemia.
• Not a substitute for emergency care: in acute ischaemic stroke or other acute ischaemic emergencies, this product is only an adjunct and must never replace time-critical standard treatments (e.g., thrombolysis, emergency stroke protocols).
• Renal/hepatic impairment: limited data are available; use with caution and closer monitoring (see Use in Special Populations).
• Driving/operating machinery: transient dizziness, hypotension, or flushing may occur after administration; avoid driving or operating machinery until you know how you respond.

Specific data on overdose with Vitafol are limited. Excessive dosing may be expected to increase the frequency/severity of known effects, particularly adenosine-related effects such as pronounced flushing, hypotension, bradycardia, or, rarely, significant atrioventricular conduction block, or hypersensitivity-type reactions related to cytochrome C. There is no specific antidote. If an overdose is suspected, stop the infusion/medicine immediately and seek immediate medical attention or contact a poison control centre/emergency services; treatment is supportive and symptomatic, with continuous monitoring of vital signs (heart rate, blood pressure, breathing) in a medical facility.

Store at room temperature (below 30°C), away from light and moisture. Keep out of reach of children. Do not use after the expiry date. Check the specific product pack for any additional storage instructions (e.g., some injectable formulations may require refrigeration or protection from freezing).

Renal impairment: use Vitafol with caution; well-established dose-adjustment data are not available, so closer clinical monitoring is advised.

Hepatic impairment: use with caution given limited data; monitor clinically.

Elderly patients: may be more sensitive to cardiovascular effects (hypotension, bradycardia); start under close monitoring, especially if other cardiac medicines are being taken.

Children: safety and efficacy have not been established (see Pediatric Uses).

Pregnancy/breastfeeding: see Pregnancy and Lactation above.

Treatment with Vitafol is typically given as a short, defined course (commonly around 7-10 days) as an adjunct during the acute or early recovery phase of the underlying condition, rather than as long-term/continuous therapy. Whether a repeat course is appropriate, and after what interval, should be decided by the treating physician based on clinical response; do not extend or repeat the course on your own.

Antihypoxants; Cellular metabolic/energy support agents; Antioxidant-supportive combinations

Sodium Succinate + Cytochrome C + Adenosine + Nicotinamide works by combining a Krebs-cycle substrate (succinate), a mitochondrial electron-transport-chain protein (cytochrome C), a nucleoside involved in cellular energy turnover (adenosine), and a NAD+/NADH precursor (nicotinamide) to support mitochondrial energy production and help reduce oxidative stress in tissue exposed to hypoxia or ischaemia.

The safety and efficacy of Vitafol in children and adolescents have not been well established through controlled paediatric studies. It should generally not be used in children unless specifically directed and closely supervised by a paediatric specialist, who will weigh the potential benefit against the limited safety data in this age group.