VITCOFOL INJECTION- IS IT SAFE? USES, SIDE EFFECTS, DOSAGE
WHAT IS VITCOFOL INJECTION?
Vitcofol injection is a parenteral Fixed Dose Combination (FDC) brand available in Indian Market.
FDC Limited is the manufacturing and marketing company of Vitcofol Injection.
It should be stored at a temperature not exceeding 25°c and away from light.
Nutritional deficiencies is one of the main indications of Vitcofol injection and other indications are listed in the following sections.
The active ingredients in the formulation are:
- Cyanocobalamin
- Folic acid
- Nicotinamide
VITCOFOL INJECTION- IS IT SAFE? USES, SIDE EFFECTS, DOSAGE
What is the Generic name(s)?
What is its composition?
How does it work?
What are its uses?
ARE THERE ANY INCOMPATIBILITIES?
HOW EFFECTIVE IS THIS MEDICINE?
HOW SHOULD IT BE STORED?
HOW IS IT ADMINISTERED?
IS IT ADDICTIVE?
WHAT IS THE DOSAGE?
WHAT ARE THE CONTRAINDICATIONS?
WHAT IF I MISS A DOSE?
WHAT TO DO IN CASE OF AN OVERDOSAGE?
WHAT TO DO IF THERE IS AN ALLERGIC REACTION?
WHAT ARE THE SIDE EFFECTS?
DOES THIS MEDICINE HAS ANY DRUG INTERACTIONS?
PRECAUTIONS
IS IT SAFE IF I AM PREGNANT?
IS IT SAFE TO USE IF I AM BREASTFEEDING?
CAN THIS MEDICINE BE GIVEN TO CHILDREN AND INFANTS?
IS THIS MEDICINE AVAILABLE AS OVER THE COUNTER PRODUCT (OTC)?
FREQUENTLY ASKED QUESTIONS (FAQs)
Reference
WHAT ARE THE GENERIC NAME(S)?
The preparation contains the following active ingredients:
-
CYANOCOBALAMIN[1] – 500 mcg/ml
It is water soluble vitamin (vitamin B12).
Indicated for the treatment of Vitamin B12 deficiency, Megaloblastic anaemia[2], Aphthous ulcer[3], Pernicious anaemia. -
FOLIC ACID[4] – 15 mg/ml
It is a water-soluble vitamin of B complex group.
Indicated for Megaloblastic, Macrocytic anaemia[5], Prevention of Neural Tube Defect (NTD[6]) and also for Methanol poisoning[7]. -
NICOTINAMIDE[8] – 200mg/ml
It is water soluble Vitamin B3.
Indicated for Pellagra (Off label use), Niacin deficiency.
WHAT IS IT’S COMPOSITION?
Each ml of Vitcofol injection contains :
- FOLIC ACID IP – 15 mg
- CYANOCOBALAMIN IP – 500 mcg
- NICOTINAMIDE IP – 200 mg
- BENZOYL ALCOHOL – 2.5% w/v
- PHENOL IP – 0.5 w/v
- WATER FOR INJECTION – qs (Quality Sufficient)
HOW DOES IT WORK?
- FOLIC ACID
Folic acid is necessary to form Red Blood Cells[9] along with Vitamin B 12. A deficiency in Folic Acid will lead to macrocytic or megaloblastic anaemia.
Folic acid is necessary for the formation of a cell’s genetic material, i.e DNA[10] to ensure healthy replication. Pregnant women are indicated to take Folic acid to prevent the development of Neural Tube Defect in the baby and also to compromise the extra need for the RBC for the baby growing.
Patients who are under certain medication like anti-seizure drugs, Methotrexate therapy, those taking birth control pills[11] is also advised to take folic acid.
- CYANOCOBALAMIN
Also known as Vitamin B 12[12].
Vitamin B12 works closely in association with Folic acid for the synthesis of the building blocks of DNA and RNA[13], which in turn is necessary for maintaining the neurological integrity and also plays a major role in the biosynthesis of fatty acid[14] and energy production.
It is involved in protein synthesis[15] and is very much essential for cell growth, reproduction, maturation and myelin synthesis. It plays a major role in hematopoiesis and nucleo-protein synthesis.
Its deficiency will lead to neurological complications. This usually starts its manifestation with bilateral paraesthesia in extremities, deficits in proprioception and vibrations.
- NICOTINAMIDE
Also known as Vitamin B3.
Though it belongs to Vitamin classification it has got anti-hyperlipidemic action as well.
At pharmacological doses, it reduces total cholesterol, LDL (Low-Density Lipoprotein) cholesterol, Triglycerides and also increases HDL (High-Density Lipoprotein) levels. Peripheral vasodilation is also a main effect of Nicotinamide.
WHAT ARE IT’S USES?
FOLIC ACID
- Megaloblastic anaemia
- Pregnancy and Lactation
- Folic acid deficiency
- Methanol Poisoning
- Prevention of Neural Tube Defect
- Drugs causing Folic acid deficiency like methotrexate.
CYANOCOBALAMIN
- Vitamin B12 deficiency due to improper utilization
- Dietary deficiency of Vitamin B12
- Malabsorption syndromes
- Vitamin B12 absorption test
NICOTINAMIDE
- Pellagra
- Hyperlipidemia (Type IV and Type V)
- Peripheral Vascular disease
- Migraine
- Meniere disease
- Vascular spasm
- Headache
ARE THERE ANY INCOMPATIBILITIES?
Cyanocobalamin is incompatible with an alkaline solution. The permissible pH range is 4.5-7. Hence, check the pH before mixing.
Generally, the pH requirement for Folic Acid is 8-11.
HOW EFFECTIVE IS THIS MEDICINE?
CYANOCOBALAMIN
It should be administered as Intra-muscularly only.
It generally takes 20 minutes-2 hours to reach a peak concentration in the blood.
The onset of action can be seen as:
- MEGALOBLASTIC ANEMIA – Conversion from megaloblastic to normoblast generally takes 8 hours
- Reticulocyte counts generally increase within 2-5 days
Under complicated Vitamin B 12 deficiency:
- Resolution of psychiatric sequelae generally occurs within 24 hours.
- Altogether resolution of thrombocytopenia takes 10 days.
- Overall granulocytopenia resolution happens within 2 weeks
FOLIC ACID
The onset of action is within 1 hour.
Other than anaemic indications, few equally important indications (Though Off label) for folic acid are
- Methanol poisoning.
- Prevention of Neural Tube Defects.
- Reduce toxicity generally associated with anti-folate therapy.
NICOTINAMIDE
In the same way as that of Folic acid and Cyanocobalamin, Nicotinamide also shows a rapid absorption.
It shows a half-life of 45 minutes and generally 20-70 minutes to reach a peak concentration.
HOW SHOULD IT BE STORED?
The label of Vitcofol Injection has mentioned in particular that it should be stored at a temperature not exceeding 25°c.
In addition to that, it should be stored away from light as well.
HOW IS IT ADMINISTERED?
Apart from its storage conditions the label also says the dose to be administered.
Administer a dose of 1 mg/ml of the preparation, says the label.
The route of administration is Intra-muscular.
IS IT ADDICTIVE?
Until now none of the contents in Vitcofol Injection has been clinically proven to have an addiction property.
And therefore the medicine does not have any addictive action till now.
WHAT IS THE DOSAGE?
1ml/day is the general dose as per the Label Guideline.
Together with the general dosage, each active ingredient has its own dosage for each condition.
They are as listed below:
FOLIC ACID
- MEGALOBLASTIC ANEMIA (due to folate deficiency) – 0.4 – 1 mg/day
- METHANOL POISONING – 50-70 mg once every 4 hour
- PREVENTION OF NEURAL TUBE DEFECT – 0.4 mg/day
CYANOCOBALAMIN
- APHTHOUS ULCER – 1000 mcg once daily for a period of 7 days.
- VITAMIN B12 DEFICIENCY – 100 mcg once daily for a period of 1 week.
- PERNICIOUS ANEMIA – 1000 mcg every day or 1000 mcg every other day for a duration of one week. Followed by 1000mcg weekly for a period of 8 weeks. Then 1000 mcg one monthly for the lifetime.
NICOTINAMIDE
- PELLAGRA – 10-50mg following every 6 hours until the signs and symptoms resolve.
WHAT ARE THE CONTRAINDICATIONS?
We list the contraindications of each active ingredient here:
FOLIC ACID
- Known hypersensitivity to Folic Acid
- A dose greater than 0.1 mg/day in Pernicious anaemia. This would eventually lead to irreversible nerve damage.
- Megaloblastic anaemia secondary to Vitamin B12 deficiency
CYANOCOBALAMIN
- Known hypersensitivity to cobalt or Vitamin B12
- Hereditary Optic Nerve Atrophy.
- Intra Venous administration will cause anaphylactic shock.
NICOTINAMIDE
- Significant and progressive Liver disease
- Active Peptic ulcer
- Severe Hypotension
- Arterial Hemorrhage
WHAT IF I MISS A DOSE?
The formulation is a prescription only medicine. Moreover, generally, the medicine will be administered by a health care professional. They will certainly make sure that you don’t miss a regular dose of the medicine.
And if it accidentally happens that you miss a dose, take the missed dose as soon as you remember that you have forgotten it.
Normally the medicine is once daily preparation as for the maintenance dose.
If the medicine is being taken for the serious illness we advise you to follow these tips:
- Keep the medicine where your eyes can catch them easily.
- Set an alarm for each dosing interval.
WHAT TO DO IN CASE OF AN OVERDOSAGE?
Seek medical help as earlier as possible to prevent any further complication which can eventually rise up.
Another serious concern related to it is Acute toxicity. This occurs as a result of administration of a higher dose than the indicated one for a longer period of time. This has to very strictly avoided.
We advise you to keenly measure the amount of medicine you take each time for administration.
WHAT TO DO IF THERE IS AN ALLERGIC REACTION?
It is always advised that you do a hypersensitivity test before the drug administration.
Patients who are allergic to aspirin will be allergic to nicotinamide as well.
We suggest an intra-dermal test dose for those patients who suspect a cyanocobalamin hypersensitivity.
Stop the drug administration as soon as you get the reaction and seek medical help.
WHAT ARE THE SIDE EFFECTS?
Here we list the side effects of each of the constituents:
FOLIC ACID
- Flushing
- Malaise
- Erythema
- Pruritis
- Skin rash
- Broncho-spasm
- Hypersensitivity
CYANOCOBALAMIN
- Pulmonary edema
- Peripheral vascular thrombosis
- Itching
- Pruritis
- Transitory exanthema
- Sever to rapid optic nerve atrophy
- Diarrhea
- Body swelling
- Pain at injection site
- Hypokalemia
- Polycythemia Vera
NICOTINAMIDE
- Hypotension
- Tachycardia
- Dizziness
- Syncope
- A headache
- Flushing
- Pruritis
- Burning sensation
- Hyperpigmentation
- Rashes
- Blurred vision
- Dry skin
- Nausea
- Bloating
- Flatulence
- Hunger
- Vomiting
- Liver damages
- Hyperuricemia
- Hyperglycemia
- Decreased Glucose Tolerance test results
DOES THIS MEDICINE HAS ANY DRUG INTERACTIONS?
The general drug interactions will be a conclusive one of all the active constituents of Vitcofol injection.
FOLIC ACID
Following drugs when administered along with (before or after) will cause an interaction:
- Fluorouracil
- Fosphenytoin
- Phenobarbitone
- Phenytoin
- Sulfasalazine
CYANOCOBALAMIN
- Administration of Chloramphenicol meanwhile the initiation of Vitcofol will eventually decrease the haematological effects of Vitamin B12.
- Administration of Colchicine and neomycin at the same time as that of Vitcofol will straightaway decrease the Gastric absorption of the medicine.
- Excessive alcohol intake during the time of Vitamin B12 will decrease the absorption all of a sudden.
NICOTINAMIDE
- Firstly, the administration of adrenergic blocking agents during the administration of Vitcofol will instantly potentiate hypotensive effect.
- Secondly, the administration of statin drugs meanwhile the Vitcofol therapy will cause an increased risk of Myopathies and Rhabdomyolysis.
PRECAUTION
Since this is a fixed-dose combination, the precaution related to all the three drugs should be considered equally important while its administration.
FOLIC ACID
- The drug should not be administered as a mono-therapy agent for anaemia as a result of Vitamin B12 deficiency. However, is it indicated for anaemia due to folic acid deficiency.
- Administration of interacting drugs together with Folic acid is not acceptable and dose adjustments are equally important.
- On the negative side, there are cases of Resistance also reported which usually occurs in patients with alcoholism and other vitamin deficiencies.
CYANOCOBALAMIN
- Cyanocobalamin administration for a period greater than 3 months will eventually lead to an irreversible degeneration of CNS lesions.
As a consequence of this spinal cord degeneration may also occur.
Therefore specific monitoring should be carried out prior to the treatment and also occasionally meanwhile the treatment is progressing. - Very recent studies have published a conclusive report making a statement that the treatment will later lead to hypokalemia.
- As a result of treatment, there also occurs Thrombocytopenia. Therefore keep monitoring blood values.
- Few diseases which will interfere with the therapy include:
Leber disease
Polycythemia Vera
Pernicious anaemia
Megaloblastic anaemia
NICOTINAMIDE
The drug should be very carefully given for these patients with the following conditions meanwhile the therapy:
Gall bladder disease prior to the treatment
Diabetes during the therapy
Former case of jaundice
Aspirin allergy patients
IS IT SAFE IF I AM PREGNANT?
Generally, the Vitcofol injection is safe during pregnancy. Even then we would like to take your attention on all the pregnancy category details of other active ingredients as well.
FOLIC ACID – It belongs to pregnancy category C. Even though bit belong to category C, till date there have been no reports of any toxicity to the fetus. Moreover, it is indicated for all pregnant ladies up to 12th week of pregnancy to take the drug. Along with this, whoever is planning to get pregnant is also advised to take folic acid.
CYANOCOBALAMIN – It belongs to pregnancy category A and is extremely safe during pregnancy
NICOTINAMIDE – Similarly as that of Cyanocobalamin, it also belongs to pregnancy category A and till date, there have been no toxic effects in the fetus
In fact, it should be noted that all vitamins cross the placental barrier and will reach the fetus.
IS IT SAFE TO USE IF I AM BREASTFEEDING?
Generally, Vitcofol is not indicated in nursing mothers.
In particular, the explanation lies to the fact that, not all constituents are studied for their lactation category and safety.
On a positive hand cyanocobalamine is safe in nursing mother but on a negative side dose greater than the daily nutrient dose is not studied and hence not indicated in nursing mothers
Apart from this, no studies have conducted on folic acid and nicotinamide for safety concerns.
CAN THIS MEDICINE BE GIVEN TO CHILDREN AND INFANTS?
Throwing light upon the fact that there are no studies conducted on children and infants regarding the safety and hence we don’t advise its usage in the pediatric population.
On the long, there are chances that the pharmaceutical companies would come up with safety studies in children.
IS THIS MEDICINE AVAILABLE AS OVER THE COUNTER PRODUCT (OTC)?
It should be noted that Vitcofol injection is not available as an OTC drug and is available as the only prescription drug.
Any pharmacy providing it under no prescription is strictly illegal and punishable.
FREQUENTLY ASKED QUESTIONS (FAQs)
- What is the storage condition of Vitcofol?
Store it in a temperature less than 25°c and not necessarily in a fridge.
Keep it away from children - What is the route of administration?
Intramuscular route is the only advisable route for Vitcofol administration until now. As a result of IV administration, there will occur severe reactions. - What are the other brands available?
Vitcofol comes as a fixed dose combination and it is equally important to mention that it is the only brand available until now. - What to do if the vial is damaged?
Feel free to return it to the pharmacy without delay. Moreover, you can also avail a new product from there instantly. - What to do if it is consumed?
Do not panic. Call the nearest physician immediately and consult them. There will not occur any fatal conditions if you reach the hospital in time.
Reference
Wikipedia page on Malnutrition
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