Betex-DN

Betex-DN

Manufacturer:

Favorex

Distributor:

DKSH
Full Prescribing Info
Contents
Methylcobalamin, alpha lipoic acid, pyridoxine hydrochloride, folic acid, thiamine mononitrate.
Description
Each hard gelatin capsule contains: Methylcobalamin 1500 mcg, Alpha Lipoic Acid USP 300 mg, Pyridoxine Hydrochloride BP 10 mg, Folic Acid BP 1.5 mg, Thiamine Mononitrate BP 100 mg, Excipients q.s.
Approved colour used for capsule shell.
Action
Pharmacology: Pharmacodynamics: Methylcobalamin 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. It is needed for nerve cells and red blood cells, and to make DNA. Vitamin B12 deficiency is the cause of several forms of anemia.
Alpha Lipoic acid is readily absorbed from the diet or as a supplement. It can regenerate vitamin C from its oxidized form, dehydroascorbic acid, and regenerate other antioxidants. Chelates transition metal ions (e.g. iron and copper), it can enhance the synthesis of glutathione, the main antioxidant within our cells. Glutathione effectively mops up all types of toxins and free radicals. However, we cannot take supplements of this antioxidant since it is unable to cross cell membranes. It can even pitch in and help when the body is lacking vitamin E. When laboratory animals were depleted of their vitamin E stores because their diet lacked this nutrient, they displayed obvious symptoms of vitamin E deficiency. However, when their diet was supplemented with ALA, the animals were completely protected.
Folic acid is vital for the biosynthesis of purines and thymidylate of nucleic acids. Defective purine biosynthesis due to folate deficiency leads to megaloblastic anemia and macrocytic anemia.
Thiamine hydrochloride (Vitamin B1): Vitamin B1 is essential for proper carbohydrate metabolism and plays an essential role in the decarboxylatlon of alpha keto acids.
Pyridoxine hydrochloride (Vitamin B6): Vitamin B6 is a constituent of the co-enzymes, pyridoxal pyrophosphate and pyridoxamine phosphate, both of which play an important role in protein metabolism.
Pharmacokinetics: Methylcobalamin: It is a water soluble vitamin. It is absorbed in the stomach by proteolysis with the help of Intrinsic Factor and is absorbed by active carrier transport mechanism. The Intrinsic Factor - B12 complex is absorbed in the terminal Ileum. It is stored in the liver. It undergoes enterohepatic circulation and is excreted in small quantities in the urine.
Alpha Lipoic acid: Exogenous racemic alpha lipoic acid orally administered is readily and nearly completely absorbed. Urinary excretion does not play a significant role in its elimination. Therefore, biliary excretion, further electrochemically inactive degradation products, and complete utilization of alpha lipoic acid as a primary substrate in the endogenous metabolism should be considered.
Folic acid: Folic acid is rapidly absorbed in the proximal portion of the small intestine. After oral administration, the Cmax can be achieved within one hour. As tetrahydrofolic acid derivative, folic acid is well-distributed in all over the body tissues and stored in hepatic tissues. Folic acid is metabolized in liver into dihydrofolate and tetrahydrofolate forms. About 90% of the administered dose is excreted via the urine.
Thiamine Mononitrate: Thiamine is absorbed from the GI tract and is widely distributed to most body tissues. It is not stored to any appreciable extent in the body and amounts in excess of requirements are excreted in the urine as unchanged thiamine or metabolites.
Pyridoxine Hydrochloride: Pyridoxine is absorbed from the GI tract and is converted to the active form pyridoxal phosphate. It is excreted in the urine as 4-pyridoxic acid.
Indications/Uses
Maintains healthy nervous system; Normalizes every system in the human body; Aids in replenishing blood levels in the body; Promotes energy metabolism; Prevents primary birth defects in pregnant women.
Dosage/Direction for Use
As a dietary supplement, take 1 capsule daily with food or as directed by a physician.
Administration: Oral Route.
Overdosage
Methylcobalamin, show a wide therapeutic range During recommended usage symptoms of overdose are not known.
High doses of alpha lipoic acid could also potentially lower blood sugar. This is often beneficial to patients who have diabetes, but it requires close monitoring of blood sugar levels.
In case of Folic acid no special procedures or antidote are likely to be needed.
Vitamin B1: Thiamine has a broad therapeutic range. Very high doses (over 10 g) have a ganglion-blocking effect, similar to that of curare, and suppress the conduction of nerve impulses.
Vitamin B6: The toxic potential of vitamin B6 can be considered as very low.
Long-term treatment (>6-12 months) of a daily dosage >50 mg vitamin B6 may, however, cause peripheral sensory neuropathy.
Contraindications
Hypersensitivity to the active substances or to any of the excipients.
Chronic conditions such as diabetes, thyroid dysfunction may be affected by alpha-lipoic acid supplementation. Please monitor such individuals closely if supplementation is needed. Also, lipoic acid may affect blood glucose control procedures during and after surgery. Patients should discontinue use at least 2 weeks before scheduled surgical procedures.
Special Precautions
Chronic conditions such as diabetes, thyroid dysfunction may be affected by alpha-lipoic acid. Please monitor such individuals closely if supplementation is needed.
Protect medicines from moisture and light.
Effects on Ability to Drive and Use Machines: Does not affect ability to drive and to use machinery.
Use In Pregnancy & Lactation
It is considered to be safe in pregnant and lactating women.
Adverse Reactions
Nausea or stomach upset, along with over-stimulation, fatigue, and insomnia.
High doses of alpha lipoic acid could also potentially lower blood sugar. This is often beneficial to patients who have diabetes, but it requires close monitoring of blood sugar levels.
Drug Interactions
Excessive alcohol consumption, antibiotics, anti-acne drugs, anti-retrovirals, anti-gout drugs, anti-hypertensives, anti-tuberculosis drugs, anti-ulcer drugs, biguanides (oral anti-diabetic drugs), histamine (H2) blocking drugs, oral contraceptives, proton pump inhibitors, sulfonamides (anti-infectives), tetracyclines (anti-infectives) and epilepsy (seizure) medications can deplete vitamin B12 levels.
Thiamine is inactivated by 5-fluorouracil as the latter competitively inhibits the phosphorylation of thiamine to thiamine pyrophosphate.
Loop diuretics, e.g. furosemide that inhibit tubular reabsorption may cause increased excretion of thiamine in long-term therapy and, thus, lowering of the thiamine level.
If taken simultaneously with L-dopa, vitamin B6 can lessen the dopa effect.
The simultaneous administration of pyridoxine antagonists (e.g. Isoniazide (INH), hydralazine, D-penicillamine or cycloserine) may increase the vitamin B6 requirement.
Beverages containing sulphite (e.g. wine) enhance thiamine degradation.
Alpha-lipoic acid may have additive effects when administered with anti-diabetic drugs. Alpha-lipoic acid may also increase the efficiency of chemotherapeutic drugs.
Storage
Store in a dry place below 30°C.
Protect from moisture & light.
ATC Classification
V06DX - Other combinations of nutrients ; Used as general nutrients.
Presentation/Packing
Cap 1's.
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