Gerovital H3 injection — the treatment schedule in the leaflet, the sensitivity test and what the studies say

Gerovital H3 injection contains 100 mg of procaine hydrochloride in a 5 ml ampoule and is given intramuscularly; intravascular injection — and therefore an IV drip — is listed among the contraindications. The schedule in the leaflet is one ampoule three times a week for four weeks, repeated 5–6 times a year, and it must begin with a procaine sensitivity test.

What it contains

Gerovital H3 100 mg/5 ml solution for injection is made by Zentiva, in Romania, and is a prescription-only medicine. According to the Summary of Product Characteristics (SmPC — *RCP* in Romanian) published by ANM (the Romanian National Agency for Medicines):

• active substance — procaine hydrochloride, 100 mg in 5 ml;
• excipients — benzoic acid, potassium metabisulphite, disodium phosphate and water for injections;
• packs — boxes of 5 or 10 brown glass ampoules.

There is also an oral form, Gerovital H3 100 mg film-coated tablets, with its own leaflet. Procaine has a long history in medicine: the SmPC describes it as a substance first used as a local anaesthetic and later as an antiarrhythmic. Its systemic use for age-related processes goes back to the work of Prof. Dr. Ana Aslan (the Romanian gerontologist who developed Gerovital).

The indication in the SmPC

The current SmPC has a single indication: "Prophylaxis of degenerative phenomena due to age."

It is worth reading exactly as written. This is the wording of the marketing authorisation, not a promise of rejuvenation. Some sources attribute other indications to it; in the current SmPC published by ANM, which we read in full, this is the only indication. What can be said about measured effects is below, in the section on the evidence.

The treatment schedule in the leaflet

The SmPC describes treatment in series, not a one-off injection:

A full series therefore means 12 injections. The oral treatment between series is described in the SmPC of the injection in terms of sugar-coated tablets; the oral form authorised today has its own leaflet, and that is the one you follow. The SmPC also mentions the possibility of an oral-only treatment, in series, depending on the situation.

The actual schedule — whether it is done at all, how many series, what breaks — is set by the doctor. The SmPC states explicitly that treatment is given under medical supervision, especially the first series, to establish the right dose.

The procaine test is not a formality

Before starting treatment, testing for sensitivity to procaine is mandatory. First 1 ml is injected subcutaneously, and after 24 hours the test is repeated with 1.5 ml intramuscularly. If any allergic reaction occurs, the treatment is contraindicated.

The practical consequence: a patient receiving it for the first time cannot have the injection on the same day. At least 24 hours must pass between the test and the first ampoule of the series, so we are talking about separate visits. Any offer promising an "injection on the spot" at the first visit skips a step that the leaflet makes mandatory.

Why there is no "Gerovital drip"

It is searched for often, so the answer needs to be clear: there is no authorised form of Gerovital H3 for infusion.

The SmPC lists "intravascular injection" among the contraindications — that is, administration directly into a blood vessel. The reason is in the section on overdose: toxic effects can appear immediately after accidental intravascular injection and include:

• effects on the central nervous system — restlessness, tremor, vertigo, ringing in the ears, up to seizures;
• respiratory effects — rapid breathing, then respiratory arrest;
• cardiovascular effects — a drop in blood pressure up to collapse, extrasystoles, ventricular fibrillation, atrioventricular block, up to cardiac arrest.

This is not a stylistic precaution. It is the reason why, with an intramuscular injection, staff check the position of the needle before injecting.

Contraindications and precautions

From the SmPC, contraindications:

• hypersensitivity to procaine or to the excipients;
• severe arterial hypotension;
• concomitant treatment with sulphonamides (except antidiabetic ones) or with anticholinesterases — neostigmine, physostigmine, pyridostigmine — and cholinesterase deficiency;
• epilepsy not controlled by medication;
• second- or third-degree atrioventricular block without a pacemaker;
• intravascular injection.

Precautions:

• orthostatic hypotension;
• prolonged QT interval — high plasma concentrations can cause severe ventricular rhythm disturbances;
• cancer — the SmPC does not recommend the medicine for cancer patients;
• pregnancy and breastfeeding — not recommended;
• the metabisulphite in the formulation can, rarely, cause severe hypersensitivity reactions and bronchospasm.

Why sulphonamides matter

The contraindication linked to sulphonamides seems odd until you read the pharmacokinetics in the SmPC. In the body, procaine is broken down by an enzyme, procaine esterase, into two metabolites: diethylaminoethanol and para-aminobenzoic acid (PABA). Antibacterial sulphonamides work precisely by blocking bacteria from using PABA, and the SmPC describes the interaction as an "antagonistic mechanism of action". The exception is the antidiabetic sulphonamides. Anticholinesterases — neostigmine, physostigmine, pyridostigmine — and cholinesterase deficiency belong to the other side of the metabolism: procaine is broken down by esterases in the blood, and when these are inhibited or missing, procaine stays in the circulation longer. That is why the list of medicines you take is discussed before the test, not after.

What you may feel after the injection

The SmPC describes minor reactions, especially at the start of treatment: dizziness, weakness, fainting and palpitations. They can be avoided if the patient stays lying down for 10–15 minutes after the injection — which is why the observation period is part of the session.

Allergic reactions, from rash and itching to anaphylactic shock, require treatment to be stopped immediately.

What the evidence says, honestly

This is the part missing from most pages about Gerovital.

• A review published in 1977 in the Journal of the American Geriatrics Society analysed 285 articles and books, covering more than 100,000 patients treated over 25 years. Its conclusion: apart from a possible antidepressant effect, there is no convincing evidence that procaine or Gerovital has value in treating diseases of old age.
• A 2008 Cochrane review on procaine for cognition and dementia found more adverse effects with procaine than with placebo (20 of 208 participants, compared with 3 of 207). Two old studies in healthy older people suggested a positive effect on memory, but the authors concluded that the evidence of adverse effects is stronger than the evidence of benefit and that marketing claims should be withdrawn until there are good-quality studies.

In short: Gerovital H3 is an authorised medicine with an important history in Romanian medicine, but it has no modern evidence supporting an anti-ageing effect. We do not present it otherwise.

How we work

We give Gerovital H3 intramuscularly — 300 RON per administration (one 5 ml ampoule), with the medical assessment included.

• at the clinic only, not at home;
• intramuscularly only — we do not and will not give Gerovital as an IV drip;
• the procaine test at a separate visit, before the first administration;
• an observation period after each injection.

At the assessment we ask about your blood pressure and any dizzy spells when you stand up, about rhythm disturbances and any ECG showing a prolonged QT interval, about epilepsy, about a cancer diagnosis and about all your current medicines, including recent antibiotics. If anything on the list applies, the discussion stops there.

The price is per administration. The leaflet describes a series of 12 injections; how many administrations are right in your case is decided at the assessment, and we tell you the total cost before you start.

If you have one of the contraindications above, or are on treatment with sulphonamides or anticholinesterases, we will tell you at the assessment that it is not an option for you.

Sources

Gerovital H3 100 mg/5 ml solution for injection — Summary of Product Characteristics, ANM (in Romanian): composition, indication, administration schedule, testing, contraindications, overdose.

Gerovital H3 100 mg/5 ml solution for injection — Package leaflet, ANM (in Romanian): information for the patient.

Ostfeld A., Smith C.M., Stotsky B.A. — The systemic use of procaine in the treatment of the elderly: a review, Journal of the American Geriatrics Society, 1977.

Szatmári S., Bereczki D. — Procaine treatments for cognition and dementia, Cochrane Database of Systematic Reviews, 2008.

Nomenclature of medicinal products for human use, ANM (in Romanian): the authorised forms of Gerovital H3, consulted on 13 September 2026.

Informational article. Gerovital H3 is a prescription-only medicine; the schedule and whether treatment is appropriate are decided by a doctor.