A-Caro-25

Name: A-Caro-25

Importance of Diet

For good health, it is important that you eat a balanced and varied diet. Follow carefully any diet program your health care professional may recommend. For your specific dietary vitamin and/or mineral needs, ask your health care professional for a list of appropriate foods. If you think that you are not getting enough vitamins and/or minerals in your diet, you may choose to take a dietary supplement.

It is documented that people who consume diets high in fruits and vegetables have a reduced risk of heart disease and certain cancers. Fruits and vegetables are rich in beta-carotene and other nutrients that may be beneficial.

Beta-carotene is found in carrots; dark-green leafy vegetables, such as spinach and green leaf lettuce; sweet potatoes; broccoli; cantaloupe; and winter squash. The body converts beta-carotene into vitamin A. Ordinary cooking does not destroy beta-carotene.

Vitamins alone will not take the place of a good diet and will not provide energy. Your body needs other substances found in food, such as protein, minerals, carbohydrates, and fat. Vitamins themselves often cannot work without the presence of other foods. For example, some fat is needed so that beta-carotene can be absorbed into the body.

Uses of A-Caro-25

  • It is used to treat or prevent vitamin A deficiency.
  • It may be given to you for other reasons. Talk with the doctor.

If OVERDOSE is suspected

If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

Consumer Information Use and Disclaimer

  • If your symptoms or health problems do not get better or if they become worse, call your doctor.
  • Do not share your drugs with others and do not take anyone else's drugs.
  • Keep a list of all your drugs (prescription, natural products, vitamins, OTC) with you. Give this list to your doctor.
  • Talk with the doctor before starting any new drug, including prescription or OTC, natural products, or vitamins.
  • Some drugs may have another patient information leaflet. Check with your pharmacist. If you have any questions about this medicine, please talk with your doctor, nurse, pharmacist, or other health care provider.
  • If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

This information should not be used to decide whether or not to take A-Caro-25 or any other medicine. Only the healthcare provider has the knowledge and training to decide which medicines are right for a specific patient. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about this medicine. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to A-Caro-25. This information is not specific medical advice and does not replace information you receive from the healthcare provider. You must talk with the healthcare provider for complete information about the risks and benefits of using this medicine.

Review Date: October 4, 2017

Drug Interactions

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. Tell your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.

Other Interactions

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

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 one 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.

If you miss a dose and you are using it as 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.

Storage

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Do not refrigerate. Keep from freezing.

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.

Beta-Carotene Levels and Effects while Breastfeeding

Summary of Use during Lactation

Beta-carotene is a plant pigment that is converted into vitamin A in the body. Maternal vitamin A requirements are increased during lactation, but there are no specific guidelines for increased beta-carotene intake or indications for high-dose supplementation in nursing mothers. Typical beta-carotene intake in a Western diet is 6 to 8 mg daily. Beta-carotene is a normal component of human colostrum and mature milk, where it contributes to antioxidant defenses in the neonate.[1] Average concentrations are 1.12 mg/L and 230 mcg/L, respectively, in the Unites States.[2] Beta-carotene supplementation during pregnancy and for 6 months postpartum in nursing mothers with poor diets in a resource-poor setting reduced the number of days of illness in the mothers,[3] but does not reduce infant morbidity or mortality according to another study.[4] The bioavailability of beta-carotene is dependent on the fat content of the meal and the form in which it is administered, with synthetic pharmaceutical forms having the best bioavailability. High-dose beta-carotene supplements lead to a slow increase in breastmilk beta-carotene concentrations, with an accumulation half-life of about 9 days. Levels drop towards baseline slowly over several weeks after discontinuation. In general, beta-carotene is well tolerated, although excessive maternal intake of beta-carotene can lead to a harmless, reversible discoloration of the breastfed infant's skin.[5] In HIV-infected women, high-dose beta-carotene plus vitamin A supplementation increases the rate of HIV viral shedding into breastmilk and increases HIV infection in breastfed infants, although the mortality rate over the first 2 years of life is not increased.[6][7] The viral shedding may be a result of an increase in subclinical mastitis caused by beta-carotene.[8] Beta-carotene concentration in breastmilk is not affected by refrigeration, freezing, or low-temperature microwaving. The concentration does decrease when milk passes through a tube feeding system, regardless of light exposure.[9]

Dietary supplements do not require extensive pre-marketing approval from the U.S. Food and Drug Administration. Manufacturers are responsible to ensure the safety, but do not need to prove the safety and effectiveness of dietary supplements before they are marketed. Dietary supplements may contain multiple ingredients, and differences are often found between labeled and actual ingredients or their amounts. A manufacturer may contract with an independent organization to verify the quality of a product or its ingredients, but that does not certify the safety or effectiveness of a product. Because of the above issues, clinical testing results on one product may not be applicable to other products. More detailed information about dietary supplements is available elsewhere on the LactMed Web site.

Drug Levels

Maternal Levels. Healthy nursing mothers in the United States were given either 60 mg (n = 6) or 210 mg (n = 6) of beta-carotene as capsules (Hoffmann-La Roche, Inc., Nutley, NJ) as a single dose. Both doses increased breastmilk beta-carotene levels to a similar extent, with peak concentrations of around 1.1 mcg/L of lipid occurring 2 to 3 days after the dose. Mothers with higher baseline beta-carotene levels had higher peak concentrations.[10]

Healthy nursing mothers in the United States were given either 7 doses of a placebo (n = 4) or of an algae-derived beta-carotene supplement containing 64 mg of all-trans beta-carotene and 69 mg 9-cis beta-carotene (Henkel Corp., LaGrange, Il). Foremilk samples of breastmilk were obtained daily for 8 days and again at 1 month after the first dose. All-trans beta-carotene levels in milk increased to about 2.1 mg/L of whole milk after 5 days of supplementation and further increased only slightly by day 8. Levels were still elevated above baseline at 1 month. Milk levels of 9-cis beta-carotene increased steadily from baseline to day 8, with a much lower peak value of about 40 ng/L. The lower value was possibly the result of isomerization of 9-cis beta-carotene to all-trans beta-carotene.[11]

Five healthy exclusively breastfeeding mothers over 1 month postpartum (average 279 days postpartum) in the United States were given 30 mg of beta-carotene as capsules (Hoffmann-La Roche, Inc. Nutley, NJ) daily for 28 days with high-fat yogurt. Milk beta-carotene levels increased an average of 6.4 fold over the 28-day period, with an average maximum concentration of about 200 mcg/L. The accumulation half-life of beta-carotene in milk was 9 days, which was almost twice a long as the accumulation half-life in serum. At one month after the end of supplementation, milk levels remained about double of baseline levels.[12]

Twenty-one postpartum women in the United States received either water-dispersible beadlets of beta-carotene in capsules (n = 11), which were assayed to contain 31 to 35 mg of beta-carotene and 1.2 mg of alpha-carotene, or an identical placebo (n = 10) daily for 4 weeks starting on 4 days postpartum. During the 4 weeks of the study, there was no significant change in average breastmilk beta-carotene concentrations, whereas those in the placebo group had a decrease in average beta-carotene milk concentrations which as not statistically significant. Differences between this study and previous studies was suggested to be caused by differences in subjects' milkfat levels which were lower in this study.[13]

A study compared 4 groups of women in West Java, Indonesia who received supplementation during pregnancy until delivery. All groups received 30 mg of iron and 0.4 mg of folic acid daily. Experimental groups received either beta-carotene 4.5 mg daily as a water-soluble granulate, zinc 30 mg daily, beta-carotene 4.5 mg plus zinc 30 mg daily, or only the iron and folic acid as a control group. Milk samples were collected during the first and sixth months postpartum. The milk beta-carotene level was significantly different from the control group only in the 6-month sample of the zinc plus beta-carotene group. The vitamin A status of the mothers and their infants was also better in the group that received beta-carotene and zinc.[14]

A study of 866 HIV-infected women in Tanzania were enrolled in a study to receive 1 of 4 supplements during pregnancy and lactation. Groups received either multivitamins, multivitamins plus vitamin A and beta-carotene, vitamin A and beta-carotene alone, or placebo daily. The beta-carotene dose was 30 mg. At 24 months of age, the multivitamin-supplemented group's infants had significantly better growth parameters than the other groups.[15]

A study of HIV-infected women in Tanzania were enrolled in a study to receive 1 of 4 supplements during pregnancy and lactation. Groups receive either multivitamins (thiamine, riboflavin, vitamin B6, niacin, vitamin B12, vitamin C, vitamin E, and folic acid), multivitamins plus vitamin A and beta-carotene, vitamin A and beta-carotene alone, or placebo daily. The beta-carotene dose was 30 mg. Breastmilk samples were collected at delivery and at 3-month intervals thereafter. Average breastmilk beta-carotene concentrations in the beta-carotene supplemented groups were consistently about 10-fold higher than in the groups that received no beta-carotene at any time up to 1 year of age.[16]

Twelve women were given carrot paste and 14 were given tomato paste with a high-fat meal once daily for 3 days. The carrot supplement contained 15 mg of all-trans beta-carotene and the tomato supplement contained 15 mg of all-trans lycopene. Breastmilk beta-carotene levels nearly doubled after 3 days of supplementation, whereas lycopene levels increased by about 15% one day after the 3 days of supplementation.[17]

Infant Levels. Relevant published information was not found as of the revision date.

Effects in Breastfed Infants

A nursing mother was eating 2 to 3 pounds of carrots a week as raw and cooked carrots. The mother's skin was yellow in color, but her sclera were clear. At 2 months of age, her breastfed infant was diagnosed as having jaundice because of a yellow coloration of the skin. Breastfeeding was discontinued and the infant's skin returned to a normal color. The mother continued her diet and examination of the maternal serum found elevated levels of beta-carotene which was probably the cause of her infant's skin discoloration.[5]

HIV-infected women in Tanzania received 1 of 4 supplements during pregnancy and lactation in a series of studies. Groups received either multivitamins (thiamine, riboflavin, vitamin B6, niacin, vitamin B12, vitamin C, vitamin E, and folic acid), multivitamins plus vitamin A and beta-carotene, vitamin A and beta-carotene alone, or placebo daily. The beta-carotene dose was 30 mg. At 24 months of age, the multivitamin-supplemented group's infants had significantly better growth parameters than the other groups.[15] One study found that the infants of mothers supplemented with vitamin A and beta-carotene had a higher rate of HIV transmission than those supplemented with multivitamins alone or placebo.[6] After 6 months postpartum, women who received vitamin A plus beta-carotene had greater shedding of the HIV virus into breastmilk than women who had not; multivitamins without vitamin A and beta-carotene did not increase viral shedding.[6] Beta-carotene appeared to have a shedding effect that was independent of vitamin A.[7] One possible explanation comes from another similar study in which those who received vitamin A plus beta-carotene alone had a 45% increased risk of severe subclinical mastitis and those who received multivitamins plus vitamin A and beta-carotene had a 29% increased risk of severe subclinical mastitis.[8]

Effects on Lactation and Breastmilk

Relevant published information was not found as of the revision date.

References

1. Ostrea EM Jr, Balun JE, Winkler R, Porter T. Influence of breast-feeding on the restoration of the low serum concentration of vitamin E and beta-carotene in the newborn infant. Am J Obstet Gynecol. 1986;154:1014-7. PMID: 3706423

2. Lawrence RA, Lawrence RM. Breastfeeding: a guide for the medical profession, 7th ed. Mosby. Maryland Heights, MO. 2011;741.

3. Christian P, West KP Jr, Khatry SK et al. Vitamin A or beta-carotene supplementation reduces symptoms of illness in pregnant and lactating Nepali women. J Nutr. 2000;130:2675-82. PMID: 11053506

4. Gogia S, Sachdev HS. Maternal postpartum vitamin A supplementation for the prevention of mortality and morbidity in infancy: a systematic review of randomized controlled trials. Int J Epidemiol. 2010;39:1217-26. PMID: 20522482

5. Thomson ML. Carotinaemia in a suckling. Arch Dis Child. 1943;18:112. Letter. PMID: 21032250

6. Fawzi WW, Msamanga GI, Hunter D et al. Randomized trial of vitamin supplements in relation to transmission of HIV-1 through breastfeeding and early child mortality. AIDS. 2002;16:1935-44. PMID: 12351954

7. Villamor E, Koulinska IN, Aboud S et al. Effect of vitamin supplements on HIV shedding in breast milk. Am J Clin Nutr. 2010;92:881-6. PMID: 20739426

8. Arsenault JE, Aboud S, Manji KP et al. Vitamin supplementation increases risk of subclinical mastitis in HIV-infected women. J Nutr. 2010;140:1788-92. PMID: 20739447

9. Tacken KJ, Vogelsang A, van Lingen RA et al. Loss of triglycerides and carotenoids in human milk after processing. Arch Dis Child Fetal Neonatal Ed. 2009;94:F447-50. PMID: 19416803

10. Canfield LM, Giuliano AR, Neilson EM et al. beta-Carotene in breast milk and serum is increased after a single beta-carotene dose. Am J Clin Nutr. 1997;66:52-61. PMID: 9209169

11. Johnson EJ, Qin J, Krinsky NI, Russell RM. Beta-carotene isomers in human serum, breast milk and buccal mucosa cells after continuous oral doses of all-trans and 9-cis beta-carotene. J Nutr. 1997;127:1993-9. PMID: 9311956

12. Canfield LM, Giuliano AR, Neilson EM et al. Kinetics of the response of milk and serum beta-carotene to daily beta-carotene supplementation in healthy, lactating women. Am J Clin Nutr. 1998;67:276-83. PMID: 9459376

13. Gossage CP, Deyhim M, Yamini S et al. Carotenoid composition of human milk during the first month postpartum and the response to beta-carotene supplementation. Am J Clin Nutr. 2002;76:193-7. PMID: 12081834

14. Dijkhuizen MA, Wieringa FT, West CE, Muhilal. Zinc plus beta-carotene supplementation of pregnant women is superior to beta-carotene supplementation alone in improving vitamin A status in both mothers and infants. Am J Clin Nutr. 2004;80:1299-307. PMID: 15531679

15. Villamor E, Saathoff E, Bosch RJ et al. Vitamin supplementation of HIV-infected women improves postnatal child growth. Am J Clin Nutr. 2005;81:880-8. PMID: 15817867

16. Webb AL, Aboud S, Furtado J et al. Effect of vitamin supplementation on breast milk concentrations of retinol, carotenoids and tocopherols in HIV-infected Tanzanian women. Eur J Clin Nutr. 2009;63:332-9. PMID: 17940544

17. Haftel L, Berkovich Z, Reifen R. Elevated milk beta-carotene and lycopene after carrot and tomato paste supplementation. Nutrition. 2015;31:443-5. PMID: 25701332

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