Sixvit Tablet

Sixvit is indicated in-

• Treatment and prevention of pyridoxine deficiency states
• Sideroblastic anaemias
• Seizures due to hereditary syndromes of pyridoxine deficiency or dependency in infants
• Depression and other symptoms associated with premenstrual syndrome & the use of oral contraceptives.
• Prophylaxis of isoniazid-induced peripheral neuritis and for the treatment of acute isoniazid toxicity.

Vitamin B6 (pyridoxine) is a water-soluble vitamin used in the prophylaxis and treatment of vitamin B6 deficiency and peripheral neuropathy in those receiving isoniazid (isonicotinic acid hydrazide, INH). Vitamin B6 has been found to lower systolic and diastolic blood pressure in a small group of subjects with essential hypertension. Hypertension is another risk factor for atherosclerosis and coronary heart disease. Another study showed pyridoxine hydrochloride to inhibit ADP- or epinephrine-induced platelet aggregation and to lower total cholesterol levels and increase HDL-cholesterol levels, again in a small group of subjects. Vitamin B6, in the form of pyridoxal 5'-phosphate, was found to protect vascular endothelial cells in culture from injury by activated platelets. Endothelial injury and dysfunction are critical initiating events in the pathogenesis of atherosclerosis. Human studies have demonstrated that vitamin B6 deficiency affects cellular and humoral responses of the immune system. Vitamin B6 deficiency results in altered lymphocyte differentiation and maturation, reduced delayed-type hypersensitivity (DTH) responses, impaired antibody production, decreased lymphocyte proliferation and decreased interleukin (IL)-2 production, among other immunologic activities.

For isoniazid-induced peripheral neuritis

Adults-

• Treatment- 50 mg three times daily
• Prophylaxis- Not suitable with this dosage form

Children: This presentation is not recommended

For idiopathic sideroblastic anaemia-

• Adults: 100 to 400 mg daily in divided doses
• Children: This presentation is not recommended

For deficiency states-

• Adults: 50 to 150 mg daily in divided doses
• Children: This presentation is not recommended
• Elderly: Dosage requirements appear to be similar to those for young adults.

Many drugs may alter the metabolism or bioavailability of pyridoxine, including isoniazid, penicillamine and oral contraceptives, which may increase the requirements for this tablet. This tablet may reduce the effect of levodopa, a drug used in the treatment of Parkinsons Disease unless a dopa decarboxylase inhibitor is also given.

Hypersensitivity to any of the ingredients.

This tablet usually has no side effects when used in recommended doses.

If your doctor has prescribed this medication, remember that he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

This tablet can cause side effects when taken in large doses for a long time. Tell your doctor right away if any of these unlikely but serious side effects occur: headache, nausea, drowsiness, numbness/tingling of arms/legs.

A very serious allergic reaction is rare. However, seek immediate medical attention if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

Data on exposed pregnancies indicate no adverse effects of pyridoxine in therapeutic doses on pregnancy or the health of the foetus or newborn child, or during lactation. Animal studies are insufficient with respect to effects on pregnancy, embryonal/foetal development, parturition or postnatal development. Caution should be exercised when prescribing to pregnant women.

If symptoms persist or worsen, seek medical advice. Do not exceed the stated dose.

If you take more tablets than you should: If you accidentally take too many tablets contact your doctor or pharmacist or nearest hospital casualty department. Take this leaflet and any remaining tablets with you to show the doctor or pharmacist.

If you miss a dose: If you forget to take a dose, take another as soon as you remember. If it is almost time for your next dose, then do not take the missed dose at all. Do not take a double dose to make up for a forgotten tablet.

Stopping tablets: You should continue to take this tablets for as long as your doctor tells you to. Do not stop taking the medicine without talking to your doctor first.

Vitamin-B preparations

Store under normal storage condition (15°C to 30°C). Protect from light.