FORTIPLEX Vitamin B Complex 300mg / 30mg / 25mg / 100mg / 250mcg Tablet 100's
NONRXDRUG-DRP-7264-01
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Features
Brand
Fortiplex
Full Details
Dosage Strength
300 mg / 30 mg / 25 mg / 100 mg / 250 mcg
Drug Ingredients
- Vitamin B Complex
Drug Packaging
Tablet 100's
Generic Name
Vitamin B Complex
Dosage Form
Tablet
Registration Number
DRP-7264-01
Drug Classification
Over-The-Counter (OTC)
Description
Indications/Uses
To treat deficiencies of vitamins B1, B2, B6, B12 and nicotinic acid manifested as: Muscle pain, loss of reflexes in the hands, knees, ankles, calves and feet and abnormal touch sensation such as burning and pricking.
As adjunct in the management of conditions responsive to high dose vitamins B1, B2, B6, B12 and nicotinic acid which include the following: Neuralgia (nerve pain), neuritis (inflammation of the nerves), neuropathies (disturbances in the function of the brain or spinal cord that may affect the nerves and muscles of the body).
Inherited metabolic disorders such as: Leigh's necrotizing encephalopathy (a rare neurometabolic disorder characterized by degeneration or gradual loss of ability of the central nervous system, which includes the brain, spinal cord, and optic nerve to function properly; inherited vitamin B6 dependency; methylmalonic aciduria [the accumulation of methylmalonic acid in the body characterized by progressive encephalopathy (brain disease that gets worse), dehydration, developmental delays, constipation, seizures and vomiting]; lactic acidosis (a disease caused by the build-up of lactic acid in the body characterized by deep and rapid breathing, vomiting and abdominal pain); Wernicke's encephalopathy (an alcohol-induced thiamine deficiency characterized by mental confusion, staggering and constant rapid eye movements); beri-beri (thiamine deficiency manifested as muscle weakness, loss of appetite, nerve degeneration (inability of nerves to function properly); use of drugs such as isoniazid, cycloserine, penicillamine, hydralazine and levodopa which induces increased requirement for vitamin B6; malabsorption syndromes.
As adjunct in the management of conditions responsive to high dose vitamins B1, B2, B6, B12 and nicotinic acid which include the following: Neuralgia (nerve pain), neuritis (inflammation of the nerves), neuropathies (disturbances in the function of the brain or spinal cord that may affect the nerves and muscles of the body).
Inherited metabolic disorders such as: Leigh's necrotizing encephalopathy (a rare neurometabolic disorder characterized by degeneration or gradual loss of ability of the central nervous system, which includes the brain, spinal cord, and optic nerve to function properly; inherited vitamin B6 dependency; methylmalonic aciduria [the accumulation of methylmalonic acid in the body characterized by progressive encephalopathy (brain disease that gets worse), dehydration, developmental delays, constipation, seizures and vomiting]; lactic acidosis (a disease caused by the build-up of lactic acid in the body characterized by deep and rapid breathing, vomiting and abdominal pain); Wernicke's encephalopathy (an alcohol-induced thiamine deficiency characterized by mental confusion, staggering and constant rapid eye movements); beri-beri (thiamine deficiency manifested as muscle weakness, loss of appetite, nerve degeneration (inability of nerves to function properly); use of drugs such as isoniazid, cycloserine, penicillamine, hydralazine and levodopa which induces increased requirement for vitamin B6; malabsorption syndromes.
Dosage/Direction for Use
Orally, one tablet daily. Or as directed by a doctor.
Missed Dose: If dose is missed, take the next dose and the subsequent doses at the usual recommended schedule, ie, once a day. Do not double the dose.
Missed Dose: If dose is missed, take the next dose and the subsequent doses at the usual recommended schedule, ie, once a day. Do not double the dose.
Overdosage
Vitamin B6: Although vitamin B6 has generally been considered relatively non-toxic, long-term (two months or longer) administration of large (megadose) dosages (usually 2 grams or more daily) of vitamin B6 can cause neurological symptoms manifested as paresthesia (more noticeable at night and limited to the extremities), bone pains (described as lightning, stabbing or shooting like a knitting needle or electric shocks), hyperesthesia (described as burning, pricking, stinging or itching), muscle weakness (difficulty in running, lifting, climbing stairs and loss of manual dexterity), fasciculation (described as twitching, restlessness or fidgeting), and numbness of the limbs and face.
Nicotinic acid: High-doses of nicotinic acid equivalent to 1.5 grams daily may cause dizziness, palpitations, shortness of breath, sweating, insomnia, nausea, vomiting, abdominal pain, and myalgia (muscle pain).
Nicotinic acid: High-doses of nicotinic acid equivalent to 1.5 grams daily may cause dizziness, palpitations, shortness of breath, sweating, insomnia, nausea, vomiting, abdominal pain, and myalgia (muscle pain).
Administration
May be taken with or without food.
Contraindications
Allergy to any component of the product.
Adverse Reactions
Pyridoxine (Vitamin B6): Undesirable neurologic effects have been reported after chronic administration of 500 mg vitamin B6 daily.
Nicotinic acid: Dosages of nicotinic acid in excess of 100 mg daily may cause flushing of the face, arms, and chest, itching and nausea.
Nicotinic acid: Dosages of nicotinic acid in excess of 100 mg daily may cause flushing of the face, arms, and chest, itching and nausea.
Drug Interactions
Neuromuscular blocking agents (eg, tubocuranine chloride, metocurine iodide, pancuronium bromide and vecuronium bromide) may be enhanced by high doses of vitamin B1 (>500 mg daily), although the clinical significance of this is unknown.
Take this medicine (Fortiplex) at least two hours before or after taking phenobarbital or phenytoin since high doses of vitamin B6 may reduce the blood levels of these drugs.
Take this medicine (Fortiplex) at least two hours before or after taking phenobarbital or phenytoin since high doses of vitamin B6 may reduce the blood levels of these drugs.
Storage
Store at temperatures not exceeding 30°C.
Action
Fortiplex contains B-complex vitamins (vitamins B1, B2, B6, B12 and nicotinic acid). These nutrients are required for the normal function of the nervous system and are used as adjunct in the management of various neuromuscular disorders.
B-complex vitamins also helps in the conversion of food to energy to support numerous normal body processes.
B-complex vitamins have the following known functions/effects:
Thiamine (B1): Involved in the production and release of acetylcholine, a neurotransmitter required in conveying signals between nerve cells; assists in the conversion of carbohydrate to energy; deficiency of vitamin B1 results in beri-beri manifested as muscle weakness, loss of appetite and nerve degeneration (inability of nerves to function properly).
Riboflavin (B2): Important for the formation of flavoproteins involved in energy release from carbohydrate, fat and protein; riboflavin deficiency is manifested as cheilosis (appearance of cracks or fissures at the corners of the mouth), glossitis (inflammation of the tongue) and dry, scaly skin.
Pyridoxine (B6): Required in the formation of neurotransmitters such as serotonin, gamma amino butyric acid (GABA), dopamine and epinephrine to facilitate normal nervous system function; assists in the breakdown and utilization of energy from amino acids and protein; deficiency of vitamin B6 is manifested as nausea, impaired immune function, skin disorders, mouth sores, weakness, mental depression, anemia and epileptic convulsions.
Cyanocobalamin (B12): Required for the synthesis of myelin, the white sheath that surrounds nerve fibers; essential in the breakdown and utilization of energy from fatty acids; deficiency of vitamin B12 is manifested as neuromuscular symptoms such as unsteadiness of the feet, poor muscle coordination and agitation.
Nicotinic acid: An important requirement for DNA repair and calcium metabolism; essential for energy release from carbohydrate, fat and protein; deficiency may result in pellagra, a condition characterized by poor appetite, pigmented rash, a bright red tongue and neurological symptoms such as depression, headache, fatigue and loss of memory.
B-complex vitamins also helps in the conversion of food to energy to support numerous normal body processes.
B-complex vitamins have the following known functions/effects:
Thiamine (B1): Involved in the production and release of acetylcholine, a neurotransmitter required in conveying signals between nerve cells; assists in the conversion of carbohydrate to energy; deficiency of vitamin B1 results in beri-beri manifested as muscle weakness, loss of appetite and nerve degeneration (inability of nerves to function properly).
Riboflavin (B2): Important for the formation of flavoproteins involved in energy release from carbohydrate, fat and protein; riboflavin deficiency is manifested as cheilosis (appearance of cracks or fissures at the corners of the mouth), glossitis (inflammation of the tongue) and dry, scaly skin.
Pyridoxine (B6): Required in the formation of neurotransmitters such as serotonin, gamma amino butyric acid (GABA), dopamine and epinephrine to facilitate normal nervous system function; assists in the breakdown and utilization of energy from amino acids and protein; deficiency of vitamin B6 is manifested as nausea, impaired immune function, skin disorders, mouth sores, weakness, mental depression, anemia and epileptic convulsions.
Cyanocobalamin (B12): Required for the synthesis of myelin, the white sheath that surrounds nerve fibers; essential in the breakdown and utilization of energy from fatty acids; deficiency of vitamin B12 is manifested as neuromuscular symptoms such as unsteadiness of the feet, poor muscle coordination and agitation.
Nicotinic acid: An important requirement for DNA repair and calcium metabolism; essential for energy release from carbohydrate, fat and protein; deficiency may result in pellagra, a condition characterized by poor appetite, pigmented rash, a bright red tongue and neurological symptoms such as depression, headache, fatigue and loss of memory.
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