Drug Interaction:
Vitamin B1- none reported.
Vitamin B2- none reported.
Vitamin B3- Lovastatin- coadmin of niacin may result in rhabdomysis - one report Sulfinpyrazones uricosuric effect may be inhibited.
Vitamin B5- none reported.
Vitamin B6- levodopa- pyridoxine reduces levodopas effectiveness.
With Phenobarbital- phenobarbital serum levels may be decreased.
With Phenytoin- phenytoin serum levels may be decreased.
Drug/lab test interactions:
Vitamin B3- decreased glucose tolerance,abnormalities of hepatic function tests,hyperuremia.
Indication:
FIXED DOSE COMBINATIONS APPROVED BY DCG(I)
FROM JANUARY 1961 TILL NOVEMBER 2014
Name of Drug Indication Date of Approval
1. Niacin 1000mg ER + 31-03-2010
Laropiprant 20mg tablet
For the treatment of dyslipidemia, particularly in
patients with combined mixed dyslipidemia
( characterized by elevated levels of LDL -
chloesterol and triglycerides and low HDL-
chloesterol ) and inpatients with primary
hypercholesterolemia ( heterozygous
familial and non-familial ) in combinatio with
HMG-CoA eductase inhibitor when cholesterol
lowering effect of HMG CoA reductase inhibitor
monotherapy is inadequate.
It can be used as momotherapy only in patients in
whom HMG-CoG reductase inhibitors are considered
as inapproprioate or not tolerated
2.Thiamine mononitrate IP 10.0mg + 26-02-2009
Riboflavin IP 10mg +
Pyridoxime HCL IP 3mg +
Vit B12 IP 15mcg +
Niacinamide IP 100mg +
Cal Pantothenate USP 50mg+
Folic acid IP 1.5mg +
Biotin USP 100mcg +
Ascorbic Acid IP 150mg capsule
For various deficiency states
3.Thiamine monohydrate IP 10mg + 26-02-2009
Riboflavin IP 10mg +
Pyrodoxine HCL IP 3mg +
Vit B12 IP 15mcg +
Niacinamide IP 100mg+
Cal Pantothenate IP 50mg +
Folic acid IPm 1.5mg+
Biotin USP 100mcg+
Ascotbic acid IP 150mg +
Zinc sulphate monohdrate USP 41.4mg
eq to 15mg Elem Zinc ) capsule
For various deficiency states
Adverse Reaction:
Vitamin B1- feeling of warmth, pruritus, urticaria, weakness, sweating, restlessness, tightness of throat, angioneurotic edema, cyanosis, pulmonary oedema, haemorrhage into GI tract, cardiovascular collapse, death. Some tenderness and induration may follow IM use.
Vitamin B2- none reported.
Vitamin B3- flushing,pruritus, GI distress appear frequently with nicotinic acid oral therapy. Activation of peptic ulcer, nausea, vomiting, abdominal pain, diarhoea. Severe generalised flushing, sensation of warmth, keratosis nigricans, pruritus, skin rash, dry skin, tingling. Toxic ambyopia, hypotension, transient headache, artial fibrillation and other cardiac arrhythmias.
Vitamin B5- none reported.
Vitamin B6- sensory neuropathic syndromes, unstable gait, numg feet, awkwardness of hands, perioral numbness, decreased sensation to touch, temperature and vibration, parathesia, somnolence, low serum folic acid levels.
Contra-Indications:
Vitamin B1- thiamine hcl.- hypersensitivity to thiamine
Vitamin B2- Riboflavin- none reported. Vitamin B5- Calcium patothenate- none reported.
Vitamin B3- Nicotinic acid- hepatic dysfunction, active peptic ulcer.
Vitamin B6- Pyridoxine- hypersensitivity to pyridoxine.
Special precautions:
Vitamin B1- sensitivity reactions can occur. Deaths have resulted from IV use. An interdermal test dose is recommended in patients with suspected sensitivity.
Risks to fetal abnormalities reported, use during only if clearly needed. Use with caution in nursing women.
Vitamin B2- Ribloflavin deficiency seldom occurs alone, often associated with B vitamins. May cause yellow/orange discolouration of urine.
Vitamin B3- schizophrenia- no convincing evidence to support megadoses of nicotinic acid in the treatment of schiziphrenzia. High doses are associated with considerable toxicity. Use doses in excess of nutritional requirements during pregnancy and lactation only when clearly needed and when the potential benefits outweigh the potential hazards to the fetus or nursing infant.
Vitamin B6- pregnancy and lactation- pyridoxine requirements are increased during pregnancy and lactation. Pyridoxine varies in concentration in breast milk in response to changes in maternal intake of the vitamin. Admininster high doses with caution.
Other Information:
For Availability/supplies
Contact -
1.Indian Drug Manufacturers Association (IDMA)
Phone- 022- 24944624/ 24974308
Fax- 022- 24950723
Email- idma@vsnl.com
Website: www.idma-assn.org
2.Bulk Drug Manufacturers Association (India)(BDMA)
Phone - 040-23703910/ 23706718
Fax- 040-23704804
Email- info@bdmai.org
Website: www.info@bdmai.org
Patient Information:
Ref - USP PDI Vol II 17th Edition (1997)
PANTOTHENIC ACID - Vitamin B 5 -Systemic
1.Allergies-
Tell your doctor if you are allergic to any substances, such as foods,
preservatives or dyes.
2.Pregnancy-
It is especially important that you are receiving enough vitamins when you
become pregnant and you continue to receive the right amount of vitamins
throughout the pregnancy. However, taking large amounts of nutrional
supplement may be harmful to the mother and/ or the fetus and should
be avoided.
3. Breast-feeding-
It is especially important that you receive the right amount of vitamins so that
the baby will also get the vitamins needed to grow. However, taking large
amounts of nutritional supplement while breast feeding may be harmful to the
mother and the baby and should be avoided
4.Children-
Problems in children have not been reported with intake of normal daily
recommended amounts.
5.Older adults-
Problems in older adults have not reported with intake of normal daily
recommended amounts.
6. Other medicines-
Tell your doctor if you are using any other prescription or non-prescription
(Over-the counter) OTC medicine or dietary supplements
Manufacturer Details