Nervamine^® is indicated in the treatment of peripheral neuropathies.

Posology

Usual adult dose

The usual daily dose for adults is 3 tablets, equivalent to a total of 1500 mcg of Mecobalamin.

Administrated orally in 3 divided doses.

The dose should be adjusted according to the age of patient and severity of symptoms.

Method of administration

Oral use

Nervamine^® should not be administrated for extensive periods (months) to patients who show no clinical response.

Prolonged use of larger doses of Nervamine^® is not recommended for patients whose occupation requires handling mercury or its compounds.

Nervamine^® has the potential to interact with certain medications such as:

·       Chloramphenicol.

·       Proton pump inhibitors.

·       H2 receptor antagonitists.

·       Metformin

·       Use during pregnancy

Nervamine^® may be taken during pregnancy if the benefit to the mother is greater than the risk to the baby. You are best to talk to your doctor and make a decision together.

·       Use during lactation

Methylcobalamin is distributed into breast milk in amounts similar to those in maternal plasma, and distribution in breast milk allows for adequate intakes of methylcobalamin by beast- feeding infants.

It is unlikely that Nervamine^® would cause an impairment of driving performance or compromise the ability to use machinery.

The most common adverse reactions include:

·       Gastrointestinal symptoms such as anorexia.

·       Gastrointestinal disorder.

·       Nausea – vomiting.

·       Diarrhea.

·       Skin rash.

To report any side effect(s):

• Saudi Arabia:

The National Pharmacovigilance Center (NPC):

SFDA Call Center: 19999

E-mail: npc.drug@sfda.gov.sa

Website: https://ade.sfda.gov.sa

• Other GCC States:

Please contact the relevant competent authority

Vitamin B12 preparations in general are usually nontoxic, even in large doses.

Pharmacotherapeutic group: Vitamin B 12 supplement, ATC Code: B03BA05                                                       

1. Promotion of the metabolism of nucleic acids, proteins and lipids
Experiments with a brain-derived cell line from albino rats have shown that mecobalamin, by acting as a coenzyme in the formation of methionine from homocysteine, is involved in the synthesis of thymidylate from deoxyundylate, and promotes the synthesis of DNA and RNA. It has also been demonstrated. In experiments using neuroglia, that mecobalamin enhances the formation of lecithin, a major component of the myelin sheath.
2. Extensive uptake by nerve tissues and improvement of metabolic disturbances
Mecobalamin, a methylated form of vitamin B12 (CH3-B12) that occurs in high concentrations in the blood and the cerebrospinal fluid, has been observed in rats to be taken up into nerve cell organelles more actively and extensively than CN-B12. Experimentation using sciatic nerve cells from rats with experimental diabetes has also demonstrated that Mecobalamin helps maintain axonal function by promoting the synthesis of structural proteins and by normalizing the transport velocity of these proteins.
3. Repair of nerve injury

Mecobalamin has been demonstrated, by neuropathological and electrophysiological studies, to inhibit nerve fiber degeneration in rats and rabbits with neuropathy induced by drugs such as Adriamycin and Vincristine or with Streptozotocin - induced diabetes. The effects of mecobalamin were also studied in guinea pig models with compression-induced facial palsy. The recovery process was evaluated using examinations of the blink reflex, evoked electromyograms, and histological observations. Mecobalamin was found to be as effective as steroids in accelerating the repair of injured nerve tissue.

Pharmacotherapeutic group: Vitamin B 12 supplement, ATC Code: B03BA05.

Animal Studies
1. Distribution

In rats given a 25 mcg oral dose of 57Co-labelled mecobalamin, radioactivity was found to be higher in the kidneys, adrenal glands, pancreas, liver, and stomach (listed in order of magnitude), whereas the muscles, testes, brain, and nerves did not show significant radioactivity 72 hours after administration.

2. Acute toxicity LD50 (mg/kg)

3. Subacute toxicity

The oral administration of mecobalamin, at doses of 0.2, 2.0 and 20mg/kg/day to rats of both sexes for 1 consecutive month, resulted in no remarkable changes in the general condition of the animals, the body weights, blood and urine analytical results, organ weights, or histopathology.

4. Chronic toxicity

In rats of both sexes, given an oral dose of 0.2, 2.0 and 20mg/kg/day of mecobalamin for 6 consecutive months, no remarkable changes were noted in the general condition of the animals, the body weights, blood and urine analytical results, organ weights, or histopathology.

5. Reproduction tests

In mature nulliparous mice and rats, administered an oral dose of 0.2, 2.0, and 20mg/kg/day of mecobalamin during organogenesis, no abnormalities or signs of teratogenicity were noted in fetuses or neonates.

Silicified microcrystalline cellulose, lactose monohydrate, calcium carbonate, croscarmellose sodium, anhydrous colloidal silica, magnesium stearate, hydroxypropylmethylcellulose, titanium dioxide, talc, polyethylene glycol, FD&C Red #40.

None.

Store below 30°C in dry place.

Protect from moisture and light.

Nervamine^® 500 mcg: Red oval biconvex film coated tablet engraved with H77 on
one face and scored on the other face, presented in white opaque high density polyethylene bottle and white opaque polypropylene cap with silica gel desiccator, intended for oral use.

Pack size: 30 Film Coated Tablets/Bottle.

Any unused medicinal product or waste material should be disposed of in accordance with local requirements.