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Methaver

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Overview

What is Methaver?

Methaver is an orally administered prescription vitamin specifically formulated for the dietary management of patients with unique nutritional needs requiring increased folate levels, as well as other Vitamin B supplementation.

Methaver should be administered under the supervision of a licensed medical practitioner. Each capsule contains the following ingredients:

Each capsule contains:Folic Acid............................................................................1mgThiamin hydrochloride..……………………………………..27mgRiboflavin……………………………………………………..29mgPyridoxine hydrochloride..............,...................................50mgMethylcobalamin……………....….……………..……………2mg

Each capsule contains the following inactive ingredients: Lactose Monohydrate, Gelatin (bovine), Silicon Dioxide, Magnesium Stearate, Titanium Dioxide, FD&C Blue #1, FD&C Red #40.

* This product is a prescription vitamin that – due to increased folate levels (AUG 2 1973 FR 20750), requires an Rx on the label because of increased risk associated with masking of B12 deficiency. As such, this product requires licensed medical supervision, an Rx status, and a National Drug Code (NDC) as required by pedigree reporting requirements.

FOLAT E REGULAT ION

The term "folate" are B vitamins that include folic acid and any forms of active pteroylglutamates regardless of the reduction state of the molecule. Folates, or vitamin B9, are primarily hydrolyzed in the intestinal jejunum and the liver to the active circulating form of folate.

Folic acid, including reduced forms1 such as folinic acid, may obscure pernicious anemia above 0.1 mg doses, and must be administered under the supervision o f a licensed medical practitioner.



What does Methaver look like?



What are the available doses of Methaver?

Sorry No records found.

What should I talk to my health care provider before I take Methaver?

Sorry No records found

How should I use Methaver?

Methaver is indicated for the distinct nutritional requirements of patients in need of dietary supplementation as determined by a licensed medical practitioner. Methaver should be administered under the supervision o f a licensed medical practitioner.

One capsule daily or as directed by a licensed medical practitioner.

Methaver capsules are supplied as purple capsules printed with 353 dispensed in HDPE plastic bottles of 30ct.

NDC 69336-353-30


What interacts with Methaver?

This product is contraindicated in patients with a known hypersensitivity to any of the ingredients.



What are the warnings of Methaver?

(4) Use in Pregnancy: There are no adequate and well-controlled studies of fluconazole in pregnant women. Available human data do not suggest an increased risk of congenital anomalies following a single maternal dose of 150 mg. A few published case reports describe a rare pattern of distinct congenital anomalies in infants exposed to high dose maternal fluconazole (400 to 800 mg/day) during most or all of the first trimester. These reported anomalies are similar to those seen in animal studies. If this drug is used during pregnancy or if the patient becomes pregnant while taking the drug, the patient should be informed of the potential hazard to the fetus. (See .)


What are the precautions of Methaver?

GeneralFolic acid when administered as a single agent in doses above 0.1 mg daily may obscure pernicious anemia, in that hematologic remission can occur while neurological manifestations remain progressive. The 2 mgs of B12 (cyanocobalamin), the amount contained in Methaver, has been shown to provide an adequate amount of B12 to address this precaution. Unmetabolized folic acid has been shown in one study of 105 postmenopausal women (50-75 yrs) to have the potential to reduce natural killer cells’ cytotoxicity, which may result in an impaired immune response.

B12 should not be used in those with Leber’s optic atrophy. Decreased levels of B have been associated with reduced ability to detoxify the cyanide in exposed individuals and B may increase the risk of irreversible neurological damage from optic atrophy in those affected with the disorder. Hydroxocobalamin can aid in the detoxification of cyanide. This form of B12, although not in this product, is an acceptable form for >B12 supplementation in those with this disorder.

Caution should be exercised when Methaver is administered to patients with diabetic nephropathy. One published study showed that among patients with diabetic nephropathy given high dose folic acid, vitamin B12, and vitamin B (pyridoxine) versus a placebo, there was a greater decrease in glomerular filtration rate (GRF).

Pregnant women and nursing mothers may be recommended to use 12 microgram doses of B12 from nutritional supplements, although higher doses should only be taken on the recommendations of a prescribing medical professional. Administration of doses of vitamin B12 greater than 10 micrograms daily may produce a hematological response in those with anemia secondary to folate deficiency.

Folate, when administered as a sing le agent in doses about 0.1 mg daily, may obscure the detection of vitamin B12 deficiency (specifically, the administration of folic acid may reverse the hematological manifestations of B12 deficiency, including pernicious anemia, while not addressing the neurological manifestations).

Folate therapy alone is inadequate for treatment of a vitamin B12 deficiency.


What are the side effects of Methaver?

Allergic sensitization has been reported following both oral and parental administration of folic acid, and may possibly occur with other forms of folate. Paresthesia, somnlence, nausea and headaches have been reported with vitamin B6. Mild transient diarrhea, polycythemiavera, itching, transitory exanthema and the feeling of swelling of the entire body have been associated with vitamin B12.


What should I look out for while using Methaver?

This product is contraindicated in patients with a known hypersensitivity to any of the ingredients.

Caution is recommended in patients with a history of bipolar illness.


What might happen if I take too much Methaver?

Sorry No Records found


How should I store and handle Methaver?

Sorry No Records found


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Clinical Information

Chemical Structure

No Image found
Clinical Pharmacology

Non-Clinical Toxicology
This product is contraindicated in patients with a known hypersensitivity to any of the ingredients.

Caution is recommended in patients with a history of bipolar illness.

Dual Blockade of the Renin-Angiotensin System (RAS)

Dual blockade of the RAS with angiotensin receptor blockers, ACE inhibitors, or aliskiren is associated with increased risks of hypotension, hyperkalemia, and changes in renal function (including acute renal failure) compared to monotherapy. Most patients receiving the combination of two RAS inhibitors do not obtain any additional benefit compared to monotherapy. In general, avoid combined use of RAS inhibitors. Closely monitor blood pressure, renal function, and electrolytes in patients on enalapril maleate tablets and other agents that affect the RAS.

Do not coadminister aliskiren with enalapril maleate in patients with diabetes. Avoid use of aliskiren with enalapril maleate in patients with renal impairment (GFR
Hypotension - Patients on Diuretic Therapy:

Patients on diuretics and especially those in whom diuretic therapy was recently instituted, may occasionally experience an excessive reduction of blood pressure after initiation of therapy with enalapril. The possibility of hypotensive effects with enalapril can be minimized by either discontinuing the diuretic or increasing the salt intake prior to initiation of treatment with enalapril. If it is necessary to continue the diuretic, provide close medical supervision after the initial dose for at least two hours and until blood pressure has stabilized for at least an additional hour (see and ).

Agents Causing Renin Release:

The antihypertensive effect of enalapril maleate is augmented by antihypertensive agents that cause renin release (e.g., diuretics).

GeneralFolic acid when administered as a single agent in doses above 0.1 mg daily may obscure pernicious anemia, in that hematologic remission can occur while neurological manifestations remain progressive. The 2 mgs of B12 (cyanocobalamin), the amount contained in Methaver, has been shown to provide an adequate amount of B12 to address this precaution. Unmetabolized folic acid has been shown in one study of 105 postmenopausal women (50-75 yrs) to have the potential to reduce natural killer cells’ cytotoxicity, which may result in an impaired immune response.

B12 should not be used in those with Leber’s optic atrophy. Decreased levels of B have been associated with reduced ability to detoxify the cyanide in exposed individuals and B may increase the risk of irreversible neurological damage from optic atrophy in those affected with the disorder. Hydroxocobalamin can aid in the detoxification of cyanide. This form of B12, although not in this product, is an acceptable form for >B12 supplementation in those with this disorder.

Caution should be exercised when Methaver is administered to patients with diabetic nephropathy. One published study showed that among patients with diabetic nephropathy given high dose folic acid, vitamin B12, and vitamin B (pyridoxine) versus a placebo, there was a greater decrease in glomerular filtration rate (GRF).

Pregnant women and nursing mothers may be recommended to use 12 microgram doses of B12 from nutritional supplements, although higher doses should only be taken on the recommendations of a prescribing medical professional. Administration of doses of vitamin B12 greater than 10 micrograms daily may produce a hematological response in those with anemia secondary to folate deficiency.

Folate, when administered as a sing le agent in doses about 0.1 mg daily, may obscure the detection of vitamin B12 deficiency (specifically, the administration of folic acid may reverse the hematological manifestations of B12 deficiency, including pernicious anemia, while not addressing the neurological manifestations).

Folate therapy alone is inadequate for treatment of a vitamin B12 deficiency.

Allergic sensitization has been reported following both oral and parental administration of folic acid, and may possibly occur with other forms of folate. Paresthesia, somnlence, nausea and headaches have been reported with vitamin B6. Mild transient diarrhea, polycythemiavera, itching, transitory exanthema and the feeling of swelling of the entire body have been associated with vitamin B12.

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Reference

This information is obtained from the National Institute of Health's Standard Packaging Label drug database.
"https://dailymed.nlm.nih.gov/dailymed/"

While we update our database periodically, we cannot guarantee it is always updated to the latest version.

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Professional

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Tips

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Interactions

Interactions

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