Trafolic Uses, Dosage, Side Effects and more

Glycine irrigation solution contains glycine which is an amino acid and a non-electrolyte. It is therefore non-conductive and suitable for irrigation purpose. Glycine Irrigation Solution minimizes the risk of intravascular haemolysis which can occur from absorption of plain water. Glycine Irrigation Solution is rapidly degraded in the liver by glycine oxidase.

Helps trigger the release of oxygen to the energy requiring cell-making process; Important in the manufacturing of hormones responsible for a strong immune system.

Mecobalamin is the neurologically active form of vitamin B12 and occurs as a water-soluble vitamin in the body. It is a cofactor in the enzyme methionine synthase, which functions to transfer methyl groups for the regeneration of methionine from homocysteine. In anaemia, it increases erythrocyte production by promoting nucleic acid synthesis in the bone marrow and by promoting maturation and division of erythrocytes.

Trade Name	Trafolic
Generic	6s-5 Methyltetrahydrofolic Acid Glucosamine Salt + Mecobalamin + Glycine + Pyridoxal-5-phosphate
Weight	527.25mcg
Type	Tablet
Therapeutic Class
Manufacturer	Sun Pharma
Available Country	India
Last Updated:	January 7, 2025 at 1:49 am

Uses

This is used for irrigating fluid of choice in:

Transurethral resection of prostate.
Endoscopic procedures within the urinary tract.
Urinary bladder surgery etc.

Mecobalamin is used for-

Peripheral Neuropathies
Diabetic Neuropathy
Verteberal Syndrome
Nerve Compression Syndrome
Multiple sclerosis
Amyotrophic lateral sclerosis
Parkinson’s disease
Alzheimer’s disease
Diabetic retinopathy
Entrapment neuropathy
Drug induced neuropathy
Megaloblastic anemia due to Vitamin B12 deficiency

Trafolic is also used to associated treatment for these conditions: Coronary vascular graft occlusion, Deep Vein Thrombosis, Myocardial Infarction, Stroke, Transient Ischemic Attack, Vascular Occlusion, Bladder distension, Bladder irrigation therapy, Irrigation therapy, Recovery, Amino acid supplementationVitamin B12 Deficiency, Nutritional supplementation

How Trafolic works

In the CNS, there exist strychnine-sensitive glycine binding sites as well as strychnine-insensitive glycine binding sites. The strychnine-insensitive glycine-binding site is located on the NMDA receptor complex. The strychnine-sensitive glycine receptor complex is comprised of a chloride channel and is a member of the ligand-gated ion channel superfamily. The putative antispastic activity of supplemental glycine could be mediated by glycine's binding to strychnine-sensitive binding sites in the spinal cord. This would result in increased chloride conductance and consequent enhancement of inhibitory neurotransmission. The ability of glycine to potentiate NMDA receptor-mediated neurotransmission raised the possibility of its use in the management of neuroleptic-resistant negative symptoms in schizophrenia.
Animal studies indicate that supplemental glycine protects against endotoxin-induced lethality, hypoxia-reperfusion injury after liver transplantation, and D-galactosamine-mediated liver injury. Neutrophils are thought to participate in these pathologic processes via invasion of tissue and releasing such reactive oxygen species as superoxide. In vitro studies have shown that neutrophils contain a glycine-gated chloride channel that can attenuate increases in intracellular calcium and diminsh neutrophil oxidant production. This research is ealy-stage, but suggests that supplementary glycine may turn out to be useful in processes where neutrophil infiltration contributes to toxicity, such as ARDS.

Dosage

Trafolic dosage

The total volume of solution used for irrigation depends on the judgment of the attending surgeon. Height from the operating table of 60 cm (approx. 2ft) is likely to cause increased intravascular absorption of glycine.

Tablet: The usual adult dosage is one 500 mcg tablet three times daily. The dosage should be adjusted according to the age of patient and the severity of symptoms.

Injection:

Peripheral neuropathies: The usual adult dosage is one ampoule equivalent to 500 mcg of Mecobalamin, administered intramuscularly or intravenously three times a week.The dosage should be adjusted according to the age of patient and the severity of symptoms.
Megaloblastic anemia: The usual adult dosage is one ampoule equivalent to 500 mcg of Mecobalamin, administered intramuscularly or intravenously three times a week. After about two months of administration, dosage should be changed to one ampoule equivalent to 500 mcg of Mecobalamin every one to three months as maintenance therapy

Check infusion set and infusion solution prior to use
Pull moderately to tear off the protective cover of the Eurohead
Hold lightly the Eurohead but not the bag
Open the flow regulator fully and hold the giving set on the top white area, but not the membrane venting region
Insert the spike of the administration set to the Eurohead and fit the connector of the administration set firmly to the needle
Gradually allow the fluid to flow down to the needle tip and close
Remove the protective cover of the needle
Locate the veinpuncture site and clean the site with an antiseptic solution, and then insert the needle
Securely tape the puncture site
Securely tape the wings and tubing
Start infusion while adjusting drip speed

Side Effects

Large intravenous doses of glycine are known to cause nausea and salivation. Other consequences of systemic absorption of glycine include electrolyte loss, diuresis, edaema, thirst, dehydration, cardiovascular and pulmonary disorders.

Generally Mecobalamin is well tolerated. However, a few side effects like GI discomfort (including anorexia, nausea or diarrhea) & rash may be seen after administration of Mecobalamin.

Toxicity

ORL-RAT LD₅₀ 7930 mg/kg, SCU-RAT LD₅₀ 5200 mg/kg, IVN-RAT LD₅₀ 2600 mg/kg, ORL-MUS LD₅₀ 4920 mg/kg; Doses of 1 gram daily are very well tolerated. Mild gastrointestinal symptoms are infrequently noted. In one study doses of 90 grams daily were also well tole.

Precaution

Precautions: Patients with cardiovascular disease should be evaluated after transurethral resection of prostate using glycine. Care should be exercised if the liver or kidney is impaired.

Warning: Aseptic technique is essential while using glycine. Unused portion should be discarded. Do not use if the bottle is leaking, solution is cloudy, contains particles or after expiry date.

The medicine should not be used for months if there is no response at all after its use for a certain period of time.

Interaction

Additives may be incompatible. When introducing additives, use aseptic technique, mix thoroughly and do not store.

Decreased GI tract absorption with neomycin, aminosalicylic acid, H2-blockers and colchicine. Reduced serum concentrations with oral contraceptives. Reduced effects in anaemia with parenteral chloramphenicol.

Elimination Route

Absorbed from the small intestine via an active transport mechanism.

Pregnancy & Breastfeeding use

Not recommended during pregnancy & lactation.

Contraindication

Glycine Irrigation Solution is not for injection in any route. It is contraindicated in patients with anuria.

Hypersensitivity to any component of this product.

Special Warning

Use in children: Not recommended.

Storage Condition

Store at controlled room temperature, protect from light and heat

Oral: Store at room temperature. Protect from moisture and light.

Parenteral: Store at room temperature. Do not expose to direct light.