Consists of Arginine, Bee Pollen, Co-Enzyme Q 10, DHA, EPA, Ginkgo Biloba Extract, Ginseng, Inositol, L-Glutamine Choline bitartrate, Lecithin, Lysine L- Carnitine, Phosphatidylserine, Royal Jelly, Safflower Oil, Soyphosphatides, Vitamin A, Wheat Germ Oil
Arginine (Kerovit) warnings
There have been two reports of possible overdosage of Arginine (Kerovit)® 10 in children.
EXTREME CAUTION MUST BE EXERCISED WHEN INFUSING Arginine (Kerovit)® 10
INTO PEDIATRIC PATIENTS. OVERDOSAGE OF Arginine (Kerovit)® 10 IN PEDIATRIC
PATIENTS CAN RESULT IN HYPERCHLOREMIC METABOLIC ACIDOSIS,
CEREBRAL EDEMA, OR POSSIBLY DEATH.
Arginine (Kerovit)® 10 should always be administered by intravenous injection because of its
hypertonicity.
A suitable antihistaminic drug should be available in the event that an allergic reaction
occurs.
Arginine (Kerovit)® 10 is a diagnostic aid and is not intended for therapeutic use.
Arginine (Kerovit)® 10 is a hypertonic (950 mOsmol/liter) and acidic (average pH of 5.6) solution
that can irritate tissues. Care should be used to insure administration of Arginine (Kerovit)® 10
through a patent catheter within a patent vein. Excessive rates of infusion may result in
local irritation and in flushing, nausea, or vomiting. Inadequate dosing or prolongation of
the infusion period may diminish the stimulus to the pituitary and nullify the test.
The Arginine (Kerovit) in Arginine (Kerovit)® 10 can be metabolized resulting in nitrogen-containing products
for excretion. The effect of an acute amino acid or nitrogen burden upon patients with
impairment of renal function should be considered when Arginine (Kerovit)® 10 is to be
administered.
The chloride content of Arginine (Kerovit)® 10 is 47.5 mEq per 100 mL of solution, and the effect
of infusing this amount of chloride into patients with electrolyte imbalance should be
evaluated before the test is undertaken.
It should be noted that the basal and post stimulation levels of growth hormone are
elevated in patients who are pregnant or are taking oral contraceptives.
Carcinogenesis, mutagenesis, and impairment of fertility
Long term animal studies have not been performed to evaluate the carcinogenic potential,
the mutagenic potential or the effect on fertility of intravenously administered Arginine (Kerovit)®
10.
Pregnancy Category B
Reproduction studies have been performed in rabbits and mice at doses 12 times the
human dose and have revealed no evidence of impaired fertility or harm to the fetus due
to Arginine (Kerovit)® 10 (10% Arginine (Kerovit) Hydrochloride Injection, USP). There have been no
adequate or well controlled studies for the use of Arginine (Kerovit)® 10 in pregnant women.
Because animal reproduction studies are not always predictive of human response, this
drug should not be used during pregnancy.
Nursing Mothers
It is not known whether intravenous administration of Arginine (Kerovit)® 10 could result in
significant quantities of Arginine (Kerovit) in breast milk. Systemically administered amino acids
are secreted into breast milk in quantities not likely to have a deleterious effect on the
infant. Nevertheless, caution should be exercised when Arginine (Kerovit)® 10 is to be administered
to nursing women.
Geriatric Use
Clinical studies of Arginine (Kerovit) did not include a sufficient number of subjects aged 65 and
over to determine whether they respond differently from younger subjects. Other reported
clinical experience has not identified differences in responses between the elderly and
younger patients.
What should I discuss with my healthcare provider before taking Arginine (Kerovit)?
- If you have an allergy to Arginine (Kerovit) or any other part of Arginine (Kerovit).
- If you are allergic to any drugs like this one, any other drugs, foods, or other substances. Tell your doctor about the allergy and what signs you had, like rash; hives; itching; shortness of breath; wheezing; cough; swelling of face, lips, tongue, or throat; or any other signs.
- If you are pregnant or may be pregnant. Do not use this medicine if you are pregnant.
This medicine may interact with other drugs or health problems.
Tell your doctor and pharmacist about all of your drugs (prescription or OTC, natural products, vitamins) and health problems. You must check to make sure that it is safe for you to take Arginine (Kerovit) with all of your drugs and health problems. Do not start, stop, or change the dose of any drug without checking with your doctor.
Arginine (Kerovit) precautions
Concerns related to adverse effects:
• Extravasation: Irritant with vesicant-like properties. Due to the hypertonicity of the IV solution, administer via IV infusion only with a patent catheter placed within a patent vein. Extravasation has resulted in burn-like reactions and skin necrosis requiring surgical intervention. Excessive rates of infusion (eg, <30 minutes) may result in local irritation.
• Hypersensitivity reactions: Severe reactions, including anaphylaxis, have been reported; if hypersensitivity occurs, discontinue and institute supportive treatment measures.
• Infusion-related reactions: Excessive rates of infusion (eg, <30 minutes) may result in flushing, nausea, or vomiting.
Disease-related concerns:
• Electrolyte imbalance: Use with caution in patients with electrolyte imbalance due to chloride content of product.
• Renal impairment: Arginine (Kerovit) metabolism results in excretion of nitrogen-containing products. Use with caution in patients with renal impairment; decreased excretion may result in an increased amino acid or nitrogen burden.
Special populations:
• Pediatric: Fatal overdose of Arginine (Kerovit) in pediatric patients has been reported. Exercise extreme caution when infusing Arginine (Kerovit). Overdosage of Arginine (Kerovit) in children can also result in hyperchloremic metabolic acidosis or cerebral edema.
What happens if I overdose Bee Pollen (Kerovit)?
Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.
What should I avoid while taking Bee Pollen (Kerovit)?
Follow your healthcare provider's instructions about any restrictions on food, beverages, or activity.
What should I discuss with my healthcare provider before taking Bee Pollen (Kerovit)?
You should not use Bee Pollen (Kerovit) if you are allergic to it.
Ask a doctor, pharmacist, or other healthcare provider if it is safe for you to use this product if you have allergies (especially to bee stings or other bee products).
It is not known whether Bee Pollen (Kerovit) will harm an unborn baby. However, there has been some concern that Bee Pollen (Kerovit) may stimulate uterine contractions. Do not use this product if you are pregnant.
It is not known whether Bee Pollen (Kerovit) passes into breast milk or if it could harm a nursing baby. Do not use this product if you are breast-feeding a baby.
Do not give any herbal/health supplement to a child without medical advice.
What happens if I miss a dose of Bee Pollen (Kerovit)?
Skip the missed dose if it is almost time for your next scheduled dose. Do not use extra Bee Pollen (Kerovit) to make up the missed dose.
Epa (Kerovit) warnings
Not available
Overdose of Ginkgo Biloba Extract (Kerovit) in details
No case of overdose has been reported.
Ginkgo Biloba Extract (Kerovit) warnings
Patients receiving anticoagulants or drugs that may affect platelet aggregation. Pregnancy category C
Ginkgo Biloba Extract (Kerovit) precautions
Single reports indicate the possibility that Ginkgo-containing preparations could increase bleeding tendency. Clinical studies do not give any evidence of an interference with blood coagulation.
It cannot be excluded that the application of Ginkgo preparations promotes the occurrence of seizures in epileptic patients. The causal relationship between such findings and the application of the product has not been demonstrated.
Patients with rare hereditary galactose intolerance, lactase deficiency or glucose-galactose malabsorption should not take Ginkgo Biloba Extract (Kerovit).
Effects in the Ability to Drive or Operate Machinery: Not relevant.
Use in pregnancy: There are no or limited amount of data from the use of Ginkgo Biloba Extract (Kerovit) in pregnant women. Animal studies do not indicate direct or indirect harmful effects with respect to reproductive toxicity. As a precautionary measure, it is preferable to avoid the use of Ginkgo Biloba Extract (Kerovit) during pregnancy.
Use in children: Ginkgo Biloba Extract (Kerovit) is not recommended for use in children and adolescents <18 years due to insufficient investigational data.
What happens if I overdose Ginseng (Kerovit)?
Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local, or emergency room immediately. Symptoms may include trouble sleeping or swelling of ankles, feet, face, or hands.
Proper storage of Ginseng (Kerovit):
Store Ginseng (Kerovit) at room temperature, between 59 and 86 degrees F (15 and 30 degrees C), in a cool, dry place. Store away from heat, moisture, and light. Do not store in the bathroom. Most herbal products are not in childproof containers. Keep Ginseng (Kerovit) out of the reach of children and away from pets.
What should I avoid while taking Ginseng (Kerovit)?
Follow your healthcare provider's instructions about any restrictions on food, beverages, or activity.
Ginseng (Kerovit) warnings
Should not be used by persons with hypoglycaemia, insulin dependent diabetes, high blood pressure or heart disorders, unless approved by their physician.
What should I discuss with my healthcare provider before taking Ginseng (Kerovit)?
Do not take Ginseng (Kerovit) without first talking to your doctor if you have a bleeding or blood clotting disorder, diabetes, high blood pressure or heart disease, or if you are taking any medicines to prevent or treat these conditions.
Talk to your doctor before taking Ginseng (Kerovit) if you have any other medical conditions, allergies (especially to plants), or if you take other medicines or herbal/health supplements. Ginseng (Kerovit) may not be recommended in some situations.
Do not take Ginseng (Kerovit) without first talking to your doctor if you are pregnant or could become pregnant. It is not known whether Ginseng (Kerovit) will harm an unborn baby.
Do not take Ginseng (Kerovit) without first talking to your doctor if you are breast-feeding a baby. It is also not known whether Ginseng (Kerovit) will harm a nursing infant.
There is no information available regarding the use of Ginseng (Kerovit) by children. Do not give any herbal/health supplement to a child without first talking to the child's doctor.
Ginseng (Kerovit) precautions
Pregnancy. Childn.
What happens if I miss a dose of Ginseng (Kerovit)?
Skip the missed dose if it is almost time for your next scheduled dose. Do not use extra Ginseng (Kerovit) to make up the missed dose.
Inositol (Kerovit) warnings
* Angina not well controlled by medical treatment (unstable angina)
* Decreased blood supply through the vessels of the brain (cerebrovascular insufficiency)
What happens if I overdose Lecithin (Kerovit)?
Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.
What should I avoid while taking Lecithin (Kerovit)?
Follow your healthcare provider's instructions about any restrictions on food, beverages, or activity.
Lecithin (Kerovit) warnings
Patients with malabsorption problems. Pregnancy.
What should I discuss with my healthcare provider before taking Lecithin (Kerovit)?
Before using Lecithin (Kerovit), talk to your healthcare provider. You may not be able to use Lecithin (Kerovit) if you have certain medical conditions.
It is not known whether Lecithin (Kerovit) will harm an unborn baby. Do not use this product without medical advice if you are pregnant.
Do not use this product without medical advice if you are breast-feeding a baby.
Do not give any herbal/health supplement to a child without medical advice.
Lecithin (Kerovit) precautions
Patients with malabsorption problems. Pregnancy.
What happens if I miss a dose of Lecithin (Kerovit)?
Skip the missed dose if it is almost time for your next scheduled dose. Do not use extra Lecithin (Kerovit) to make up the missed dose.
What happens if I overdose Royal Jelly (Kerovit)?
Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.
What should I avoid while taking Royal Jelly (Kerovit)?
Avoid taking Royal Jelly (Kerovit) with other herbal/health supplements that can lower your blood pressure. This includes andrographis, casein protein, cat's claw, coenzyme Q-10, fish oil, L-Royal Jelly (Kerovit), lycium, stinging nettle, and theanine.
Royal Jelly (Kerovit) warnings
Folic acid in doses above 1.0 mg daily may obscure pernicious anemia, in that hematologic remission can occur while neurological manifestations remain progressive.
PEDIATRIC USE
Safety and effectiveness in pediatric patients has not been established.
GERIATRIC USE
Clinical studies on this product have not been performed to determine whether elderly subjects respond differently from younger subjects. In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy.
What should I discuss with my healthcare provider before taking Royal Jelly (Kerovit)?
You should not use this product if you are allergic to Royal Jelly (Kerovit) or if you have:
-
asthma or allergies.
Ask a doctor, pharmacist, or other healthcare provider if it is safe for you to use this product if you have:
-
low blood pressure; or
-
skin irritation or swelling.
It is not known whether Royal Jelly (Kerovit) will harm an unborn baby. Do not use this product without medical advice if you are pregnant.
It is not known whether Royal Jelly (Kerovit) passes into breast milk or if it could harm a nursing baby. Do not use this product without medical advice if you are breast-feeding a baby.
Royal Jelly (Kerovit) is thought to be possibly safe in children when taken for up to 6 months. Do not give any herbal/health supplement to a child without medical advice.
What happens if I miss a dose of Royal Jelly (Kerovit)?
Skip the missed dose if it is almost time for your next scheduled dose. Do not use extra Royal Jelly (Kerovit) to make up the missed dose.
What happens if I overdose Vitamin A (Kerovit)?
Seek emergency medical attention or call the Poison Help line at 1-800-222-1222. An overdose of vitamin A can cause serious or life-threatening side effects.
Overdose symptoms may include nausea, vomiting, loss of appetite, vision changes, hair loss, peeling skin, cracked skin around your mouth, changes in menstrual periods, dizziness, drowsiness, tired feeling, bone or joint pain, severe headache, pain behind your eyes, severe stomach pain, dark urine, or jaundice (yellowing of the skin or eyes).
Overdose of Vitamin A (Kerovit) in details
The following amounts have been found to be toxic orally. Toxicity manifestations depend on the age, dosage, size, and duration of administration.
Acute toxicity — single dose (25,000 Units/kg body weight)
Infant: 350,000 Units
Adult: Over 2 million Units
Chronic toxicity (4,000 Units/kg body weight for 6 to 15 months)
Infants 3 to 6 months old: 18,500 Units (water dispersed)/day for 1 to 3 months.
Adult: 1 million Units daily for three days; 50,000 Units daily for longer than 18 months; 500,000 Units daily for two months.
Hypervitaminosis A Syndrome:
- 1.
- General manifestations:
Fatigue, malaise, lethargy, abdominal discomfort, anorexia, and vomiting.
- 2.
- Specific manifestations:
- a. Skeletal: hepatotoxicity, hard tender cortical thickening over the radius and tibia, migratory arthralgia, slow growth, and premature closure of the epiphysis leading to arrested bone growth in children.
b. Central Nervous System: irritability, headache, and increased intracranial pressure as manifested by bulging fontanels, papilledema, and exophthalmos.
c. Dermatologic: fissures of the lips, drying and cracking of the skin, alopecia, scaling, massive desquamation, and increased pigmentation.
d. Systemic: hypomenorrhea, hepatosplenomegaly, hepatotoxicity, jaundice, leukopenia, vitamin A plasma level over 1,200 Units/100 mL.
The treatment of hypervitaminosis A consists of immediate withdrawal of the vitamin along with symptomatic and supportive treatment.
What should I avoid while taking Vitamin A (Kerovit)?
Avoid taking orlistat (alli, Xenical) or mineral oil while you are taking vitamin A.
Vitamin A (Kerovit) warnings
Avoid overdosage. Keep out of the reach of children.
Pediatric Use: Polysorbates have been associated with E-Ferol syndrome (thrombocytopenia, renal dysfunction, hepatomegaly, cholestasis, ascites, hypotension and metabolic acidosis) in low birth-weight infants.
What should I discuss with my healthcare provider before taking Vitamin A (Kerovit)?
- If you have an allergy to vitamin A or any other part of Vitamin A (Kerovit) (vitamin A tablets and capsules).
- If you are allergic to any drugs like this one, any other drugs, foods, or other substances. Tell your doctor about the allergy and what signs you had, like rash; hives; itching; shortness of breath; wheezing; cough; swelling of face, lips, tongue, or throat; or any other signs.
- If you have too much vitamin A in the blood.
This medicine may interact with other drugs or health problems.
Tell your doctor and pharmacist about all of your drugs (prescription or OTC, natural products, vitamins) and health problems. You must check to make sure that it is safe for you to take this medicine with all of your drugs and health problems. Do not start, stop, or change the dose of any drug without checking with your doctor.
Vitamin A (Kerovit) precautions
General: Protect from light. Prolonged daily dose administration over 25,000 Units vitamin A should be under close supervision. Blood level assays are not a direct measure of liver storage. Liver storage should be adequate before discontinuing therapy. Single vitamin A deficiency is rare. Multiple vitamin deficiency is expected in any dietary deficiency.
Drug Interactions: Women on oral contraceptives have shown a significant increase in plasma vitamin A levels.
Carcinogenesis: There are no studies that show that administration of vitamin A will cause or prevent cancer.
Pregnancy Category X:
Nursing Mothers: The U.S. Recommended Daily Allowance (RDA) of vitamin A (5,000 Units) is recommended for nursing mothers.
What happens if I miss a dose of Vitamin A (Kerovit)?
Take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.
Wheat Germ Oil (Kerovit) warnings
in patients subjected to a restricted diet or low sugar, should be taken into account the caloric and carbohydrate intake linked to taking this drug.
Calories: 5 kcal per tablet.
References
- DailyMed. "L-GLUTAMINE: DailyMed provides trustworthy information about marketed drugs in the United States. DailyMed is the official provider of FDA label information (package inserts).". https://dailymed.nlm.nih.gov/dailyme... (accessed September 17, 2018).
- DrugBank. "Safflower - DrugBank". http://www.drugbank.ca/drugs/DB10905 (accessed September 17, 2018).
- DrugBank. "Ginseng - DrugBank". http://www.drugbank.ca/drugs/DB01404 (accessed September 17, 2018).
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Information checked by Dr. Sachin Kumar, MD Pharmacology
