Thiamilate (Oral, Injection)

Vitamins are substances that your body needs for growth and health. You only need them in small amounts, and they usually come from the foods you eat. Thiamine (vitamin B 1) is important for breaking down carbohydrates.

Certain conditions may increase your need for thiamine, such as:

• Alcoholism
• Burns
• Diarrhea (ongoing)
• Fever (ongoing)
• Illness (ongoing)
• Intestinal disease
• Liver disease
• Overactive thyroid
• Stress (ongoing)
• Surgical removal of stomach

Additionally, the following groups of people might have low thiamine levels:

• Patients using an artificial kidney (on hemodialysis)
• Individuals who do heavy manual labor daily

Your health care professional should determine if you need more thiamine.

Not getting enough thiamine can lead to a condition called beriberi. Signs of beriberi can include loss of appetite, constipation, muscle weakness, pain or tingling in the arms or legs, and possible swelling in the feet or lower legs. In severe cases, a lack of thiamine may cause mental depression, memory issues, weakness, shortness of breath, and a fast heartbeat. Your health care professional may treat this by prescribing thiamine.

Thiamine may also be used for other conditions as decided by your health care professional.

Claims that thiamine is effective for treating skin issues, chronic diarrhea, tiredness, mental problems, multiple sclerosis, nerve issues, and ulcerative colitis (a disease of the intestines), or as an insect repellent or to boost appetite have not been proven.

Injectable thiamine is given only by or under the supervision of your health care professional. Other forms of thiamine can be obtained without a prescription.

To maintain good health, it is important to eat a balanced and varied diet. Carefully follow any diet plan your health care professional recommends. For your specific dietary vitamin and/or mineral needs, ask your health care professional for a list of suitable foods. If you think you are not getting enough vitamins and/or minerals from your diet, you might consider taking a dietary supplement.

Thiamine is found in various foods, including cereals (whole-grain and enriched), peas, beans, nuts, and meats (especially pork and beef). Some thiamine in foods may be lost during cooking.

Vitamins alone cannot replace a good diet and will not provide energy. Your body also needs other substances found in food, such as protein, minerals, carbohydrates, and fat. Vitamins often cannot function properly without other foods.

The daily amount of thiamine needed is defined in several ways.

• For U.S.—
• Recommended Dietary Allowances (RDAs) are the amounts of vitamins and minerals required for adequate nutrition in most healthy individuals. RDAs for a specific nutrient may vary based on a person's age, sex, and physical condition (e.g., pregnancy).
• Daily Values (DVs) are used on food and dietary supplement labels to show the percent of the recommended daily amount of each nutrient that a serving provides. DV replaces the previous term of United States Recommended Daily Allowances (USRDAs).

• For Canada—
• Recommended Nutrient Intakes (RNIs) are used to determine the amounts of vitamins, minerals, and protein necessary for adequate nutrition and to reduce the risk of chronic disease.

Normal daily recommended intakes in milligrams (mg) for thiamine are generally defined as follows:

If you are taking this dietary supplement without a prescription, please read and follow any precautions on the label carefully. For this supplement, consider the following:

Allergies

Inform your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also, let your healthcare professional know if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

No problems in children have been reported with normal daily recommended amounts.

Geriatric

No problems in older adults have been reported with normal daily recommended amounts. Studies show that older adults may have lower blood levels of thiamine than younger adults. Your healthcare professional may suggest that you take a vitamin supplement that includes thiamine.

Breast Feeding

Studies in women indicate that this medication poses minimal risk to the infant when used during breastfeeding.

Interactions with Medicines

Some medicines should not be used together at all, while in other cases, two different medicines may be used together even if an interaction might happen. In these situations, your doctor may want to adjust the dose or take other precautions. When you are taking this dietary supplement, it is very important that your healthcare professional knows if you are taking any of the following medicines. The following interactions have been chosen based on their potential importance and may not include all possible interactions.

Using this dietary supplement with any of the following medicines may increase the risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you take one or both of the medicines.

• Capecitabine
• Doxifluridine
• Fluorouracil
• Tegafur

Interactions with Food/Tobacco/Alcohol

Some medicines should not be taken at or around mealtimes or with certain types of food due to possible interactions. Using alcohol or tobacco with certain medicines may also cause interactions. Talk to your healthcare professional about using your medicine with food, alcohol, or tobacco.

Along with its needed effects, a medicine may cause some unwanted effects. Not all of these side effects may occur, but if they do, they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

Rare

Soon after receiving injection only

• Coughing
• difficulty in swallowing
• hives
• itching of skin
• swelling of face, lips, or eyelids
• wheezing or difficulty in breathing

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

In the U.S.

• Thiamilate

Available Dosage Forms:

• Tablet
• Solution

Therapeutic Class: Nutritive Agent

Pharmacologic Class: Vitamin B (class)

Dosing

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

• For oral dosage forms (tablets, oral solution): To prevent deficiency, the amount taken by mouth is based on normal daily recommended intakes: For the U.S. Adult and teenage males—1.2 to 1.5 milligrams (mg) per day. Adult and teenage females—1 to 1.1 mg per day. Pregnant females—1.5 mg per day. Breast-feeding females—1.6 mg per day. Children 7 to 10 years of age—1 mg per day. Children 4 to 6 years of age—0.9 mg per day. Children birth to 3 years of age—0.3 to 0.7 mg per day. For Canada Adult and teenage males—0.8 to 1.3 mg per day. Adult and teenage females—0.8 to 0.9 mg per day. Pregnant females—0.9 to 1 mg per day. Breast-feeding females—1 to 1.2 mg per day. Children 7 to 10 years of age—0.8 to 1 mg per day. Children 4 to 6 years of age—0.7 mg per day. Children birth to 3 years of age—0.3 to 0.6 mg per day. To treat deficiency: Adults and teenagers—Treatment dose is determined by prescriber for each individual based on the severity of deficiency. The following dosage has been established: Beriberi—Oral, 5 to 10 mg three times a day. Children—Treatment dose is determined by prescriber for each individual based on the severity of deficiency. The following dosage has been established: Beriberi—Oral, 10 a day.

Missed Dose

If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

If you miss taking a vitamin for 1 or more days there is no cause for concern, since it takes some time for your body to become seriously low in vitamins. However, if your health care professional has recommended that you take this vitamin, try to remember to take it as directed every day.

Storage

Store the dietary supplement in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.