Triaz Foaming Cloth

benzoyl peroxide foaming cloth

Dosage Form: cloth
TRIAZ®

(benzoyl peroxide) 3%, 6%, & 9%

Foaming Cloths

Rx Only

Triaz Foaming Cloth Description

TRIAZ (benzoyl peroxide) 3%, 6%, and 9% Foaming Cloths are topical preparations containing benzoyl peroxide for use in the treatment of acne vulgaris. Benzoyl peroxide is an oxidizing agent that possesses antibacterial properties and is classified as a keratolytic. Benzoyl peroxide (C14H10O4) is represented by the following chemical structure:

TRIAZ 3% and 6% Foaming Cloths contain, respectively, benzoyl peroxide 3% and 6% as the active ingredient in a cleanser-based formulation consisting of: purified water USP, sodium cocoyl isethionate, sodium methyl cocoyl taurate, cetyl alcohol NF, sodium lauryl sulfoacetate and disodium laureth sulfosuccinate, carbomer 1342 NF, sodium hydroxide NF, glycolic acid, hydroxypropyl methylcellulose, zinc lactate, sodium PCA, glycerin USP, docusate sodium USP, sodium hyaluronate, and simethicone USP.

TRIAZ 9% Foaming Cloths contains benzoyl peroxide 9% as the active ingredient in a cleanser-based formulation consisting of: puried water USP, sodium cocoyl isethionate, sodium methyl cocoyl taurate, cetyl alcohol NF, sodium lauryl sulfoacetate and disodium laureth sulfosuccinate, carbomer copolymer type B NF, glycolic acid, sodium hydroxide NF, hydroxypropyl methylcellulose, zinc lactate, sodium PCA, glycerin USP, docusate sodium USP, sodium hyaluronate, and simethicone USP.

Triaz Foaming Cloth - Clinical Pharmacology

The mechanism of action of benzoyl peroxide is not totally understood but its antibacterial activity against Propionibacterium acnes is thought to be a major mode of action. In addition, patients treated with benzoyl peroxide show a reduction in lipids and free fatty acids, and mild desquamation (drying and peeling activity) with simultaneous reduction in comedones and acne lesions. Little is known about the percutaneous penetration, metabolism, and excretion of benzoyl peroxide, although it has been shown that benzoyl peroxide absorbed by the skin is metabolized to benzoic acid and then excreted as benzoate in the urine. There is no evidence of systemic toxicity caused by benzoyl peroxide in humans.

Indications and Usage for Triaz Foaming Cloth

TRIAZ 3%, 6%, and 9% Foaming Cloths are indicated for the topical treatment of acne vulgaris.

Contraindications

These preparations are contraindicated in patients with a history of hypersensitivity to any of their components.

Warnings

When using this product, avoid unnecessary sun exposure and use a sunscreen. Keep out of reach of children.

Precautions

General

For external use only. If severe irritation develops, discontinue use and institute appropriate therapy. After reaction clears, treatment may often be resumed with less frequent application. These preparations should not be used in or near the eyes or on mucous membranes.

Information for Patients

Avoid contact with eyes, eyelids, lips and mucous membranes. If accidental contact occurs, rinse with water. Contact with any colored material (including hair and fabric) may result in bleaching or discoloration. If excessive irritation develops, discontinue use and consult your physician.

Carcinogenesis, Mutagenesis, Impairment of Fertility

Data from several studies employing a strain of mice that are highly susceptible to developing cancer suggest that benzoyl peroxide acts as a tumor promoter. The clinical significance of these findings to humans is unknown. Benzoyl peroxide has not been found to be mutagenic (Ames Test) and there are no published data indicating it impairs fertility.

Pregnancy

Teratogenic Effects

Pregnancy Category C

Animal reproduction studies have not been conducted with benzoyl peroxide. It is not known whether benzoyl peroxide can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Benzoyl peroxide should be used by a pregnant woman only if clearly needed. There are no available data on the effect of benzoyl peroxide on the later growth, development and functional maturation of the unborn child.

Nursing Mothers

It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when benzoyl peroxide is administered to a nursing woman.

Pediatric Use

Safety and effectiveness in children have not been established.

Adverse Reactions

Allergic contact dermatitis and dryness have been reported with topical benzoyl peroxide therapy.

Overdosage

If excessive scaling, erythema or edema occurs, the use of these preparations should be discontinued. To hasten resolution of the adverse effects, cool compresses may be used. After symptoms and signs subside, a reduced dosage schedule may be cautiously tried if the reaction is judged to be due to excessive use and not allergenicity.

Triaz Foaming Cloth Dosage and Administration

Wash affected areas once or twice daily, or as directed by your physician. Wet face with water. Wet cloth with a little water and work into a full lather. Cleanse face with cloth for 10–20 seconds. Avoid eyes or mucous membranes. Rinse thoroughly and pat dry. If drying occurs, it may be controlled by rinsing sooner or using less often. Throw away cloth. Do not flush.

How is Triaz Foaming Cloth Supplied

	SIZE	NDC NUMBER
TRIAZ 3% Foaming Cloths	3.2 g. Individual foil-wrapped cloths, 60 per box
		NDC 99207-224-60
TRIAZ 6% Foaming Cloths	3.2 g. Individual foil-wrapped cloths, 60 per box
		NDC 99207-225-60
TRIAZ 9% Foaming Cloths	3.2 g. Individual foil-wrapped cloths, 60 per box
		NDC 99207-226-60

Store at 15°–25°C (59°–77°F).

U.S. Patent 5,648,389 and Patents Pending

Manufactured for:

Medicis, The Dermatology Company, Scottsdale, AZ 85256

by: Tapemark, West St. Paul, MN 55118

Made in U.S.A.

Prescribing information as of July 2009

www.Triaz.com

15100077

PRINCIPAL DISPLAY PANEL - 60 Cloth Carton (3%)

NDC 99207-224-60

TRIAZ®

(benzoyl peroxide)

3%

Foaming Cloths

60

Cloths

Net wt.

3.2 g each

PRINCIPAL DISPLAY PANEL - 60 Cloth Carton (6%)

NDC 99207-225-60

TRIAZ®

(benzoyl peroxide)

6%

Foaming Cloths

60

Cloths

Net wt.

3.2 g each

PRINCIPAL DISPLAY PANEL - 60 Cloth Carton (9%)

NDC 99207-226-60

TRIAZ®

(benzoyl peroxide)

9%

Foaming Cloths

60

Cloths

Net wt.

3.2 g each

TRIAZ  benzoyl peroxide  cloth

Product Information Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 99207-224 Route of Administration TOPICAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength benzoyl peroxide (benzoyl peroxide) benzoyl peroxide 30 mg  in 1 g

Inactive Ingredients Ingredient Name Strength water   cetyl alcohol   sodium lauryl sulfoacetate   disodium laureth sulfosuccinate   sodium hydroxide   glycolic acid   hypromelloses   zinc lactate   sodium pyrrolidone carboxylate   glycerin   docusate sodium   hyaluronate sodium   silicon dioxide   dimethicone

Product Characteristics Color      Score      Shape Size Flavor Imprint Code Contains

Packaging # NDC Package Description Multilevel Packaging 1 99207-224-03 30 POUCH In 1 CARTON contains a POUCH 1 3.2 g In 1 POUCH This package is contained within the CARTON (99207-224-03) 2 99207-224-60 60 POUCH In 1 CARTON contains a POUCH (99207-224-01) 2 99207-224-01 3.2 g In 1 POUCH This package is contained within the CARTON (99207-224-60)

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
UNAPPROVED DRUG OTHER		05/27/2009	03/04/2011

TRIAZ  benzoyl peroxide  cloth

Product Information Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 99207-225 Route of Administration TOPICAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength benzoyl peroxide (benzoyl peroxide) benzoyl peroxide 60 mg  in 1 g

Inactive Ingredients Ingredient Name Strength water   cetyl alcohol   sodium lauryl sulfoacetate   disodium laureth sulfosuccinate   sodium hydroxide   glycolic acid   hypromelloses   zinc lactate   sodium pyrrolidone carboxylate   glycerin   docusate sodium   hyaluronate sodium   silicon dioxide   dimethicone

Product Characteristics Color      Score      Shape Size Flavor Imprint Code Contains

Packaging # NDC Package Description Multilevel Packaging 1 99207-225-03 30 POUCH In 1 CARTON contains a POUCH 1 3.2 g In 1 POUCH This package is contained within the CARTON (99207-225-03) 2 99207-225-60 60 POUCH In 1 CARTON contains a POUCH (99207-225-01) 2 99207-225-01 3.2 g In 1 POUCH This package is contained within the CARTON (99207-225-60)

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
UNAPPROVED DRUG OTHER		03/15/2009	03/04/2011

TRIAZ  benzoyl peroxide  cloth

Product Information Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 99207-226 Route of Administration TOPICAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength benzoyl peroxide (benzoyl peroxide) benzoyl peroxide 90 mg  in 1 g

Inactive Ingredients Ingredient Name Strength water   cetyl alcohol   sodium lauryl sulfoacetate   disodium laureth sulfosuccinate   glycolic acid   sodium hydroxide   hypromelloses   zinc lactate   sodium pyrrolidone carboxylate   glycerin   docusate sodium   hyaluronate sodium   silicon dioxide   dimethicone

Product Characteristics Color      Score      Shape Size Flavor Imprint Code Contains

Packaging # NDC Package Description Multilevel Packaging 1 99207-226-03 30 POUCH In 1 CARTON contains a POUCH 1 3.2 g In 1 POUCH This package is contained within the CARTON (99207-226-03) 2 99207-226-60 60 POUCH In 1 CARTON contains a POUCH (99207-226-01) 2 99207-226-01 3.2 g In 1 POUCH This package is contained within the CARTON (99207-226-60)

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
UNAPPROVED DRUG OTHER		02/01/2010	03/04/2011

Labeler - Medicis Pharmaceutical Corp. (182837492)

Establishment
Name	Address	ID/FEI	Operations
Tapemark		006154595	MANUFACTURE

Establishment
Name	Address	ID/FEI	Operations
Contract Pharmaceutical Limited		248761249	MANUFACTURE

Revised: 03/2011Medicis Pharmaceutical Corp.

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Iobenguane sulfate I 131

Iobenguane sulfate I 131 Injection

Diagnostic - For Intravenous Use

Iobenguane sulfate I 131 Description

Iobenguane sulfate I 131 Injection is a sterile, pyrogen free radiopharmaceutical for intravenous injection. Each milliliter contains 0.69 mg of iobenguane sulfate, 85.1 MBq (2.30 mCi) of I 131 (as Iobenguane sulfate I 131 at calibration), 0.36 mg of sodium acetate, 0.27 mg of acetic acid, 4.2 mg of sodium chloride, 0.56 mg of methyl paraben, 0.056 mg of propylparaben and 0.01 mL of benzyl alcohol. Iobenguane sulfate I 131 is also known as I 131-meta-iodobenzylguanidine sulfate (I 131 MIBG) and has the following structural formula:

Iobenguane sulfate I 131

(I 131-meta-iodobenzylguanidine sulfate)

Physical Characteristics

Iobenguane sulfate I 131 is a radioiodinated arylalkylguanidine. It is similar in structure to the anti-hypertensive drug guanethidine and to the neurotransmitter norepinephrine.

Iodine 131 decays by beta and gamma emission and has a physical half-life of 8.04 days. The principal beta particles and those photons that are useful for detection and imaging are listed in Table 1.

Table 1: Principal Radiation Emission Data

Radiation	Mean Percentage Disintegration	Energy (kev)
Beta-1	2.1	69.4 avg
Beta-3	7.4	96.6 avg
Beta-4	89.3	191.6 avg
Gamma-7	6.14	284.3
Gamma-14	81.7	364.5
Gamma-17	7.17	637.0

External Radiation

The specific gamma ray constant for I 131 is 2.2 R/mCi/hr at 1cm. The first half-value thickness of lead (Pb) for I 131 is 0.24 cm. The relative attenuation of the radiation emitted by this radionuclide that results from interposition of various thicknesses of Pb is shown in Table 2; i.e. the use of 2.55 cm of Pb will decrease the external radiation exposure by a factor of about 1,000.

Table 2: Radiation Attenuation by Lead Shielding*

* Calculations include the effect of buildup factors (the contribution of scatter photons to the dose rate). Radioactive decay factors should be applied to the stated value for radioactive concentration at the time of injection and are given in Table 3. [Data from the Oak Ridge Associated Universities, Radiopharmaceutical Internal Dose Information Center, 1987.]
Shield Thickness (Pb) cm	Coefficient of Attenuation
0.24	0.5
0.89	10-1
1.60	10-2
2.55	10-3
3.73	10-4

Table 3: Physical Decay Chart: I 131 Half-life = 8.04 Days

Days	Activity x Calibration	Days	Activity x Calibration
-14	3.343	1	0.917
-13	3.067	2	0.842
-12	2.814	3	0.772
-11	2.581	4	0.708
-10	2.368	5	0.650
-9	2.173	6	0.596
-8	1.993	7	0.547
-7	1.828	8	0.502
-6	1.677	9	0.460
-5	1.539	10	0.422
-4	1.412	11	0.387
-3	1.295	12	0.355
-2	1.188	13	0.326
-1	1.090	14	0.299
Calibration Date	1.000

Iobenguane sulfate I 131 - Clinical Pharmacology

General

Iobenguane sulfate I 131 enters adrenergic neurons and chromaffin cells primarily by the type I (active transport) mechanism of catecholamine uptake into adrenergic storage granules. Its uptake is blocked by drugs which interfere with catecholamine uptake (see drug interaction section). Within about 2 hours, 80% of Iobenguane sulfate I 131 distributes from plasma to erythrocytes and body tissues. After background clearance, visualization of abnormal adrenal medullary tissue peaks at about 48 hours post-injection. Normal adrenal glands are seen faintly in 2% of patients. Normal salivary glands, liver, spleen, and urinary bladder may also be seen to a lesser extent. Excretion is primarily by the kidneys.

Pharmacokinetics

The pharmacokinetics profile of Iobenguane sulfate I 131 fits a 3 compartment model. The physical half-life of I 131 is 8.04 days. The maximum biologic half-life of Iobenguane sulfate I 131 (including metabolites), computed by the Sigma minus method from urinary excretion data from patients with normal renal function, is about 5 days.

Metabolism

In patients with normal renal function, the major metabolites that account for less than 10% of the administered dose are m-iodohippuric action (MIHA), m-iodobenzoic acid (MIBA) and 4-hydroxy-3-iodobenzylguanidine (HIBG) and radioiodide. The enzymatic process responsible for metabolism has not been well characterized and the pharmacologic activity of these metabolites has not been studied.

In patients with normal renal function, about 50% of the injected radioactivity was recovered in urine during the first 24 hours after the infusion. About 90% was recovered in the urine by 4 days, primarily as unchanged iobenguane. Elimination is relatively independent of dose from 0.5 mCi (0.15 mg) to approximately 213 mCi (5mg).

Pharmacodynamics

Iobenguane sulfate I 131 localizes within intracellular adrenergic storage granules. Glomerular filtration is primarily responsible for extracellular clearance of Iobenguane sulfate I 131 from the body. In a 192 hour study of an anephric patient, elimination was not noted. The formation of metabolites increases in patients with renal impairment and may increase in patients with substantial tumor burdens (e.g.; an extensively metabolizing pheochromocytoma). Elimination by other routes is not well characterized. Iobenguane sulfate I 131 is not cleared by dialysis. Dosage adjustments in renally impaired patients have not been studied.

CLINICAL TRIALS

Three clinical trials were performed in a total of 397 evaluable patients with suspected pheochromocytoma. Of these subjects, 212 were males and 185 were females. The mean age was 46.3 years (range of 1-85 years). About two-thirds of the patients were between 31 and 60 years of age; 25 subjects were less than 20 years; 5 were less than 10 years of age. The mean weight of all subjects was 78.6 kg (range of 7.6-189 kgs).A racial distribution is not available.

Patients were entered into the study who, after consideration of their clinical history, physical examination and laboratory findings, were considered to have reasonable suspicion of having pheochromocytoma. Pregnant women were excluded. The diagnosis of pheochromocytoma was confirmed by other diagnostic procedures (plasma and urinary catecholamine, clonidine suppression tests and abdominal CT scans). Adult patients up to 65 kg received 0.5 mCi Iobenguane sulfate I 131, those >65 kg received 0.3 mCi/m2. Children received 0.3 mCi/m2.

Based upon dosimetry calculation from biodistribution studies, the mean dose was 0.519 mCi (range 0.10 to 1.10 mCi). All subjects had their thyroid gland iodine uptake blocked with Potassium Iodide Oral Solution (120 mg KI/day = 0.12 mL/day) or Lugol’s Solution (up to 40 mg I/day = 0.3 mL/day). In diagnosing pheochromocytoma, Iobenguane sulfate I 131 had an overall sensitivity of 71% and overall specificity rate of 94%. Within a subgroup of 293 patients who had the presence or absence of disease confirmed, there were 25 false negative and 7 false positive scans.

In further analysis of patients with confirmed pheochromocytoma, in patients who were not on medications that could potentially interfere with Iobenguane sulfate I 131 uptake, the sensitivity was 83%; in patients on potentially interfering medications, the sensitivity was reduced to 52%. The specificity was not altered. This suggests that in previously undiagnosed pheochromocytoma patients, the concomitant use of potentially blocking medications may confound the scan results.

In another trial, 72 patients were studied for suspected neuroblastoma. Of these subjects, there was an equal gender distribution. The mean age was 4.3 years (range 0.3-27 years); 46 of the 72 patients were between 1 and 5 years of age, 3 patients were over 15 years, 11 patients were under 1 year of age. The mean weight was 19.2 kg (range 3.1-115.1 kgs). A racial distribution is not available.

Patients suspected clinically of having neuroblastoma were included in the study. Most patients had other diagnostic procedures (bone scans, CT scans, MRI, etc.) before they were asked to participate in the study. Critically ill patients were generally excluded. Adults up to 65 kg received 0.5 mCi, those >65 kg received 0.3 mCi/m2 Iobenguane sulfate I 131. Children received 0.3 mCi/m2. Based on dosimetry calculations from biodistribution studies, the mean dose was 0.231 mCi (range from 0.063 to 1.031 mCi). All subjects received Potassium Iodide Oral Solution (120 mg KI/day = 0.12 mL/day) or Lugol’s Solution (up to 40 mg I/day = 0.3 mL/day) to block thyroid uptake. In this trial, Iobenguane sulfate I 131 localized neuro-blastomas with an 85.1% sensitivity and 92.0% specificity. There were 4 false negative and 2 false positive scans. None of the children on these trials were on medication that could potentially interfere with the uptake of Iobenguane sulfate I 131.

Indications and Usage for Iobenguane sulfate I 131

Iobenguane sulfate I 131 Injection is indicated as an adjunctive diagnostic agent in the localization of primary or metastatic pheochromocytomas and neuroblastomas.

GERIATRIC USE

Clinical studies of Iobenguane sulfate I 131 did not include sufficient numbers 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. 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.

Contraindications

Iobenguane sulfate I 131 is contraindicated in patients with known hypersensitivity to iobenguane sulfate.

Warnings

As with other I 131 containing agents, in order to decrease thyroid accumulation of I 131, block the thyroid gland with iodine. (See DOSAGE AND ADMINISTRATION section)

During and following the injection, patients with known or suspected pheochromocytoma should be carefully monitored for hypertensive crises.

Precautions

General

Iobenguane sulfate I 131 IS CLEARED BY GLOMERULAR FILTRATION AND IS NOT DIALYZABLE. Caution should be exercised when administering the drug to renally impaired patients. Iobenguane sulfate I 131 is not recommended in anephric patients. The radiation dose to the anephric patient would be substantially increased due to the delayed biological elimination of the drug. Also, because of the lack of clearance, the target-to-background ratios would severely compromise the outcome of the study. Iobenguane sulfate I 131 use in patients with impaired renal function should be carefully considered. As with all radio-iodinated compounds, the patient should be well hydrated before and during examination.

Although iodinated contrast imaging agents have been confirmed to cause anaphylactic reactions in patients with hypersensitivity to iodine, the incidence of hypersensitivity reactions to Iobenguane sulfate I 131 is rare. Since hypersensitivity or immune reactions are not concentration dependent, emergency treatment measures should be available.

Cardiac

Electrocardiographic (ECG) changes have been documented in dogs after the administration of 18 times the mg/m2 conversion of the maximum human dose of Iobenguane sulfate I 131. The maximum no observable effect level (NOEL) is not known. It is unknown if Iobenguane sulfate I 131 can produce changes in ECG recordings in man.

Drug Interactions

There are literature reports about patients and about in-vitro systems which suggest that the following drugs have the potential to decrease uptake of Iobenguane sulfate I 131 in neuro-endocrine tumors and may lead to false negative results if administered concomitantly: anti-hypertensives (labetalol, reserpine, calcium channel blockers), amitriptyline and derivatives, imipramine and derivatives, doxepin, amoxapin, and loxapin, sympathetic-amines (phenyl-ephrine, phenylpropanolamine, pseudoephedrine, ephedrine) and cocaine. The clinical studies were not designed to show which drugs could cause false negative results. It is unknown if other drugs in the same classes have the same potential to inhibit the uptake of Iobenguane sulfate I 131. Increasing the dose of Iobenguane sulfate I 131 will not overcome any potential uptake-limiting effect of these drugs.

Normal biodistribution and excretion of Iobenguane sulfate I 131 leads to localization in adrenergic storage granules of the adrenal gland. It is also localized in salivary glands, liver, spleen and urinary bladder. As in all nuclear imaging procedures, careful positioning may be useful in distinguishing normal biodistribution of the agent from localization in sites of pathology.

Carcinogenesis, Mutagenesis, Impairment of Fertility

Studies with Iobenguane sulfate I 131 have not been conducted to evaluate carcinogenic potential, mutagenic potential, or effects on fertility.

Pregnancy Category C

Animal reproduction studies have not been conducted with Iobenguane sulfate I 131. It is also not known whether Iobenguane sulfate I 131 can cause fetal harm when administered to a pregnant woman or if it can affect reproductive capacity. Therefore, Iobenguane sulfate I 131 should not be administered to a pregnant woman unless the potential benefit justifies the potential risk to the fetus.

Nursing Mothers

I 131 is excreted in human milk; it is not known if Iobenguane sulfate I 131 is excreted in human milk. Therefore, breast feeding should be substituted with formula feeding until the Iobenguane sulfate I 131 has cleared from the body of the nursing woman.

PEDIATRIC USE

The safety and effectiveness of Iobenguane sulfate I 131 have been reasonably established in pediatric patients with neuroblastoma and pheochromocytoma.

Safety, effectiveness, metabolism, urinary excretion and tumor specificity of Iobenguane sulfate I 131 is unknown in neonates.

Adverse Reactions

Transient episodes of marked hypertension have been reported in patients after injection of Iobenguane sulfate I 131. Some of these patients were on anti-hypertensives and others were not.

Nausea, vomiting and sleepiness have been reported after injection of higher than the recommended doses of Iobenguane sulfate I 131. The no effect level for these reactions has not been identified. An episode of fever, chills and hypotension has been reported. In clinical trials, no deaths have been attributed to the drug.

Iobenguane sulfate I 131 Dosage and Administration

Before administration of Iobenguane sulfate I 131, the patient’s thyroid gland should be blocked with Potassium Iodide Oral Solution (120 mg KI/day = 0.12 mL/day) or Lugol’s Solution (up to 40 mg I/day = 0.3 mL/day). The blocking iodine should be administered one day before and daily for 5 to 7 days after the dose of Iobenguane sulfate I 131

Adults

The recommended dose in adults is 0.5 mCi. In obese patients over 1.7 m2 (65 kg), the dose should be 0.3 mCi/m2 up to a maximum of 1.0 mCi.

Pediatric Patients

The recommended dose in pediatric patients is 0.3 mCi/m2 up to a maximum total dose of 0.5 mCi. The minimum recommended dose for adequate imaging is 0.135 mCi.

Iobenguane sulfate I 131 should be injected by slow intravenous infusion over 15-30 seconds (longer if necessary). Since the possibility of rebound hypertension exists, the patient’s vital signs should be carefully monitored during and after injection.

In order to maintain sterility, it is essential that the user follow directions and adhere to strict aseptic procedure. As in the use of any radioactive material, care should be taken to insure minimum radiation exposure to the patient and clinical personnel.

Waterproof gloves should be worn by the user and a shielded syringe should be used during the preparation and administration of the dose. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration.

The patient dose should be measured by a suitable radioactivity calibration system immediately prior to administration.

Radiopharmaceuticals should be used only by physicians who are qualified by training and experience in the safe use of radionuclides, and whose experience and training have been approved by the appropriate government agency authorized to license the use of radionuclides.

Radiation Dosimetry

The estimated absorbed radiation doses to adults and children from an intravenous dose of Iobenguane sulfate I 131 are shown in Table 4.

Table 4: Estimated Absorbed Radiation Doses*: Iobenguane Sulfate I-131

Organ	Adult		15 Years		10 years		5 years		1 years		Newborn
	mGy/ 37 MBq	rads/ 1mCi	mGy/ 18.5 MBq	rads/ 0.5 mCi	mGy/ 18.5 MBq	rads/ 0.5 mCi	mGy/ 18.5 MBq	rads/ 0.5 mCi	mGy/ 18.5 MBq	rads/ 0.5 mCi	mGy/ 18.5 MBq	rads/ 0.5 mCi
Urinary
Bladder
Wall	28.0	2.8	18.5	1.9	28.0	2.8	43.5	4.4	85.0	8.5	215.0	21.5
Liver	29.0	2.9	19.0	1.9	29.5	3.0	43.5	4.4	85.0	8.5	190.0	19.0
Spleen	22.0	2.2	15.5	1.6	24.5	2.5	38.5	3.9	70.0	7.0	195.0	19.5
Heart Wall	2.9	0.3	1.9	0.2	2.9	0.3	4.5	0.5	8.5	0.9	19.5	2.0
Adrenals	7.5	0.8	5.5	0.6	8.0	0.8	10.5	1.1	16.5	1.7	16.5	1.7
Gallbladder
Wall	5.1	0.5	3.0	0.3	4.4	0.4	7.0	0.7	12.5	1.3	28.0	2.8
Pancreas	3.8	0.4	2.4	0.2	3.8	0.4	6.0	0.6	10.5	1.1	23.5	2.4
Thyroid	3.3	0.3	2.6	0.3	4.0	0.40	8.5	0.9	16.5	1.7	24.0	2.4
Kidneys	3.2	0.3	2.0	0.2	3.1	0.3	4.9	0.5	8.5	0.9	20.0	2.0
Uterus	3.3	0.3	2.1	0.2	3.3	0.3	5.0	0.5	9.5	1.0	22.0	2.2
Ovaries	2.7	0.3	1.8	0.2	2.8	0.3	4.4	0.4	8.5	0.9	19.5	2.0
Testes	2.2	0.2	1.4	0.1	2.3	0.2	3.7	0.4	7.0	.7	17.5	1.8
Brain	1.7	0.2	1.1	0.1	1.9	0.2	3.1	0.3	6.0	0.6	15.0	1.5
Effective Dose Equivalent (rem)		0.7		0.5		0.8		1.2		2.2		5.0

* Based on data gathered in patients – Jacobsson et al, 4 International Radiopharmaceutical 

Dosimetry Symposium, CONF – 851113, pp. 389-398. 

Estimate calculated using phantoms of Christy & Eckerman (Report ORNL/TM-8381/V1 & V7).

The effective dose equivalent is a quantity which may be suitable for comparing risks of different procedures in nuclear medicine, radiology, and other applications involving ionizing radiation, but should not be construed to give information about risks to individual patients and should not be applied to situations involving radiation therapy.

The following organs each receive less than 1 rad per adult procedure: breasts, LLI wall, small intestine, stomach, ULI wall, lungs, muscle, red marrow, bone surfaces, skin and thymus.

If 0.5 mCi of Iobenguane sulfate I 131 is used for an adult dose, the organ burden would be half of the doses listed above. The thyroid gland estimated burden is in the unblocked state. When the thyroid gland is blocked with Lugol’s solution, uptake in minimal.

Peak scans were generally noted at 48 hours post-injection. However, serial scans at 24, 48 and 72 hours post-injection may be needed to optimally define the tumor.

How is Iobenguane sulfate I 131 Supplied

Each 2 ml glass vial contains a total volume of 0.5 mL with a total activity of, at calibration time,

42.6 MBq (1.15 mCi) of Iobenguane sulfate I 131 Injection.

Store the drug frozen at a temperature of -20 to -10°C.

 

Note

Two to three hours prior to use, thaw the vial in the leaded container, at room temperature.

Discard the unused portion of the drug after 4-6 hours if kept at room temperature.

In conformance with USP recommendations, Iodine 131 preparations should not be used after

the expiration date stated on the label.

NDC # 45567-0100-1

Manufactured in the USA by

Pharmalucence, Inc.

10 DeAngelo Drive

Bedford, MA 01730

 

This radiopharmaceutical is approved for distribution to persons licensed to use radioactive material listed in Section 120.547, Code of Massachusetts Regulation 105, or under equivalent license of the U.S. Nuclear Regulatory Commission or an Agreement State.

RM 2I-006

03/08

Iobenguane sulfate I 131 INJECTION  Iobenguane sulfate I 131 injection  injection

Product Information Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 45567-0100 Route of Administration INTRAVENOUS DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength IOBENGUANE I-131 (IOBENGUANE I-131) IOBENGUANE I-131 2.3 mCi  in 2 mL

Inactive Ingredients Ingredient Name Strength IOBENGUANE I-131 0.69 mg  in 2 mL SODIUM ACETATE 0.36 mg  in 2 mL ACETIC ACID 0.27 mg  in 2 mL SODIUM CHLORIDE 4.2 mg  in 2 mL METHYLPARABEN 0.56 mg  in 2 mL PROPYLPARABEN 0.056 mg  in 2 mL BENZYL ALCOHOL 0.01 mL  in 2 mL

Product Characteristics Color      Score      Shape Size Flavor Imprint Code Contains

Packaging # NDC Package Description Multilevel Packaging 1 45567-0100-1 2 mL In 1 VIAL None

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
NDA	NDA020084	03/25/1994	09/07/2009

Labeler - Pharmalucence, Inc. (139261648)

Revised: 09/2009Pharmalucence, Inc.

More Iobenguane sulfate I 131 resources

• Iobenguane sulfate I 131 Drug Interactions
• Iobengua

Antidiabetic combinations

A drug may be classified by the chemical type of the active ingredient or by the way it is used to treat a particular condition. Each drug can be classified into one or more drug classes.

Antidiabetic combinations are medicines with two or more classes of antidiabetic agents (with different mechanisms of action) in one pill or dose. Just having one pill may improve compliance and better glycemic control.

See also

Medical conditions associated with antidiabetic combinations:

• Cardiovascular Risk Reduction
• Diabetes, Type 2
• High Cholesterol
• High Cholesterol, Familial Heterozygous
• High Cholesterol, Familial Homozygous

Drug List:

Actoplus-Met-Xr-Extended-Release-Tablets

Duetact

Kombiglyze-Xr

Avandaryl

Janumet

Glucovance

Actoplus_Met

Avandamet

Juvisync

Metaglip

Prandimet

PreNexa

Pronunciation: pree-NATE-al MUL-tee-VYE-ta-mins/VYE-ta-min A/MIN-er-als/EYE-urn/FOE-lik AS-id/DOK-ue-sate SOE-dee-um
Generic Name: Prenatal Multivitamin without Vitamin A with Minerals, Iron, Folic Acid, Docusate Sodium, and DHA
Brand Name: Examples include PreNexa and Taron-Prex

Accidental overdose of products that contain iron is a leading cause of fatal poisoning in children younger than 6 years old. Keep this and all medicines out of the reach of children. In case of accidental ingestion, call your local poison control center or your doctor at once.

PreNexa is used for:

Treating or preventing a lack of vitamins or minerals before, during, and after pregnancy and while breast-feeding. It may also be used for other conditions as determined by your doctor.

PreNexa is a vitamin, mineral, iron, folic acid, docosahexaenoic acid (DHA), and stool softener combination. It works by providing vitamins and minerals to the body to help meet nutritional requirements. The stool softener helps prevent constipation that may occur with iron products.

Do NOT use PreNexa if:

• you are allergic to any ingredient in PreNexa, including soy, fish, or fish oil


• you have hemochromatosis (a disorder of iron metabolism)

Contact your doctor or health care provider right away if any of these apply to you.

Before using PreNexa:

Some medical conditions may interact with PreNexa. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

• if you are pregnant, planning to become pregnant, or are breast-feeding


• if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement


• if you have allergies to medicines, foods, or other substances


• if you have stomach or intestinal problems (eg, colitis, Crohn disease, diverticulitis, peptic ulcer), blood problems (eg, pernicious anemia, other types of anemia, porphyria), bleeding problems (eg, hemophilia), or a history of kidney stones


• if you have had multiple blood transfusions


• if you are taking mineral oil

Some MEDICINES MAY INTERACT with PreNexa. Tell your health care provider if you are taking any other medicines, especially any of the following:

• Oral anticoagulants (eg, warfarin) because the risk of bleeding may be increased by PreNexa


• Fluorouracil because its actions and the risk of its side effects may be increased by PreNexa


• Hydantoins (eg, phenytoin), methyldopa, or penicillamine because their effectiveness may be decreased by PreNexa

This may not be a complete list of all interactions that may occur. Ask your health care provider if PreNexa may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use PreNexa:

Use PreNexa as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• Take PreNexa by mouth with or without food. If stomach upset occurs, take with food to reduce stomach irritation.


• Take PreNexa by mouth with a full glass of water (8 oz/240 mL).


• Do not take an antacid within 1 hour before or 2 hours after you take PreNexa.


• Avoid taking PreNexa with dairy products; they may interfere with the absorption of the iron in PreNexa.


• Many medicines (eg, used for infection, blood pressure, low blood platelets, osteoporosis, thyroid problems) should not be taken at the same time as PreNexa; their effectiveness may be decreased. Ask your doctor or pharmacist if your dose of PreNexa should be separated from your dose of any of your other medicines.


• If you miss a dose of PreNexa, take it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once.

Ask your health care provider any questions you may have about how to use PreNexa.

Important safety information:

• PreNexa may discolor the stools. This is normal and not a cause for concern.


• PreNexa has iron in it. Iron overdose is a leading cause of fatal poisoning in children younger than 6 years old. In case of an overdose, call a doctor or poison control center right away.


• PreNexa has pyridoxine (vitamin B₆) in it. Before you start any new medicine, check the label to see if it has pyridoxine (vitamin B₆) in it too. If it does or if you are not sure, check with your doctor or pharmacist.


• Some brands of PreNexa may contain fish oil or soy. If you have had an allergic reaction to fish, fish oil, or soy, ask your pharmacist if your brand contains fish oil.


• This product may contain tartrazine dye (FD&C Yellow No. 5). This may cause an allergic reaction in some patients. If you have ever had an allergic reaction to tartrazine, ask your pharmacist if your product has tartrazine in it.


• Do not take large doses of vitamins while you use PreNexa unless your doctor tells you to.


• PREGNANCY and BREAST-FEEDING: PreNexa is intended for use during pregnancy and breast-feeding. If you are or will be breast-feeding while you use PreNexa, check with your doctor.

Possible side effects of PreNexa:

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Constipation; dark or discolored stools; diarrhea; nausea; stomach upset; vomiting.

Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); black, tarry stools; blood or streaks of blood in the stools; stomach pain or cramping.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

See also: PreNexa side effects (in more detail)

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately. Symptoms may include black, tarry stools; chest pain; lack of feeling alert; loss of balance; seizure; severe nausea, vomiting, diarrhea, or stomach pain; shortness of breath; sluggishness; trouble breathing; unusual tiredness or weakness; unusually pale skin; weak pulse.

Proper storage of PreNexa:

Store PreNexa at room temperature, between 68 and 77 degrees F (20 and 25 degrees C). Store away from heat, moisture, and light. Do not store in the bathroom. Keep PreNexa out of the reach of children and away from pets.

General information:

• If you have any questions about PreNexa, please talk with your doctor, pharmacist, or other health care provider.


• PreNexa is to be used only by the patient for whom it is prescribed. Do not share it with other people.


• If your symptoms do not improve or if they become worse, check with your doctor.


• Check with your pharmacist about how to dispose of unused medicine.

This information is a summary only. It does not contain all information about PreNexa. If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.

Issue Date: February 1, 2012

Database Edition 12.1.1.002

Copyright © 2012 Wolters Kluwer Health, Inc.

More PreNexa resources

• PreNexa Side Effects (in more detail)
• PreNexa Use in Pregnancy & Breastfeeding
• PreNexa Drug Interactions
• PreNexa Support Group
• 2 Reviews for PreNexa - Add your own review/rating

• PreNexa Concise Consumer Information (Cerner Multum)


• PreNexa Prescribing Information (FDA)


• CitraNatal Assure Prescribing Information (FDA)


• CitraNatal Harmony Prescribing Information (FDA)


• Concept DHA Prescribing Information (FDA)


• Docosavit Prescribing Information (FDA)


• Folcal DHA Prescribing Information (FDA)


• Folcaps Care One Prescribing Information (FDA)


• Gesticare DHA Prescribing Information (FDA)


• Inatal Advance Prescribing Information (FDA)


• Inatal Ultra Prescribing Information (FDA)


• Multi-Nate DHA Prescribing Information (FDA)


• Multi-Nate DHA Extra Prescribing Information (FDA)


• Multifol Plus Concise Consumer Information (Cerner Multum)


• Natelle One Prescribing Information (FDA)


• Paire OB Plus DHA Prescribing Information (FDA)


• PreferaOB Prescribing Information (FDA)


• Prenatal Plus Prescribing Information (FDA)


• Prenatal Plus Iron Prescribing Information (FDA)


• Prenate Elite tablets


• Prenate Elite Prescribing Information (FDA)


• Prenate Essential Prescribing Information (FDA)


• PrimaCare ONE capsules


• Renate DHA Prescribing Information (FDA)


• Se-Natal 19 Prescribing Information (FDA)


• Tandem DHA Prescribing Information (FDA)


• Tandem OB Prescribing Information (FDA)


• TriAdvance Prescribing Information (FDA)


• Triveen-PRx RNF Prescribing Information (FDA)


• UltimateCare ONE NF Prescribing Information (FDA)


• Vinate AZ Prescribing Information (FDA)


• Zatean-CH Prescribing Information (FDA)

Compare PreNexa with other medications

• Vitamin/Mineral Supplementation during Pregnancy/Lactation

Folivan-OB

Generic Name: prenatal multivitamins (PRE nay tal VYE ta mins)

Brand Names: Advance Care Plus, Bright Beginnings, Cavan Folate, Cavan One, Cavan-Heme OB, Cenogen Ultra, CitraNatal Rx, Co Natal FA, Complete Natal DHA, Complete-RF, CompleteNate, Concept OB, Docosavit, Dualvit OB, Duet, Edge OB, Elite OB 400, Femecal OB, Folbecal, Folcaps Care One, Folivan-OB, Foltabs, Gesticare, Icar Prenatal, Icare Prenatal Rx, Inatal Advance, Infanate DHA, Kolnatal DHA, Lactocal-F, Marnatal-F, Maternity, Maxinate, Mission Prenatal, Multi-Nate 30, Multinatal Plus, Nata 29 Prenatal, Natachew, Natafort, Natelle, Neevo, Nestabs, Nexa Select with DHA, Novanatal, NovaStart, O-Cal Prenatal, OB Complete, OB Natal One, Ob-20, Obtrex DHA, OptiNate, Paire OB Plus DHA, PNV Select, PNV-Total, PR Natal 400, Pre-H-Cal, Precare, PreferaOB, Premesis Rx, PrenaCare, PrenaFirst, PrenaPlus, Prenatabs OBN, Prenatabs Rx, Prenatal 1 Plus 1, Prenatal Elite, Prenatal Multivitamins, Prenatal Plus, Prenatal S, Prenatal-U, Prenate Advanced Formula, Prenate DHA, Prenate Elite, Prenavite FC, PreNexa, PreQue 10, Previte Rx, PrimaCare, Pruet DHA, RE OB Plus DHA, Renate, RightStep, Rovin-NV, Se-Care, Se-Natal One, Se-Plete DHA, Se-Tan DHA, Select-OB, Seton ET, Strongstart, Stuart Prenatal with Beta Carotene, Tandem OB, Taron-BC, Tri Rx, TriAdvance, TriCare, Trimesis Rx, Trinate, Triveen-PRx RNF, UltimateCare Advance, Ultra-Natal, Vemavite PRX 2, VeNatal FA, Verotin-BY, Verotin-GR, Vinacal OR, Vinatal Forte, Vinate Advanced (New Formula), Vinate AZ, Vinate Care, Vinate Good Start, Vinate II (New Formula), Vinate III, Vinate One, Vitafol-OB, VitaNatal OB plus DHA, Vitaphil, Vitaphil Aide, Vitaphil Plus DHA, Vitaspire, Viva DHA, Vol-Nate, Vol-Plus, Vol-Tab Rx, Vynatal F.A., Zatean-CH, Zatean-PN

What are Folivan-OB (prenatal multivitamins)?

There are many brands and forms of prenatal vitamin available and not all brands are listed on this leaflet.

Prenatal vitamins are a combination of many different vitamins that are normally found in foods and other natural sources.

Prenatal vitamins are used to provide the additional vitamins needed during pregnancy. Minerals may also be contained in prenatal multivitamins.

Prenatal vitamins may also be used for purposes not listed in this medication guide.

What is the most important information I should know about prenatal vitamins?

There are many brands and forms of prenatal vitamin available and not all brands are listed on this leaflet.

Never take more than the recommended dose of a multivitamin. Avoid taking any other multivitamin product within 2 hours before or after you take your prenatal vitamins. Taking similar vitamin products together at the same time can result in a vitamin overdose or serious side effects.

Many multivitamin products also contain minerals such as calcium, iron, magnesium, potassium, and zinc. Minerals (especially taken in large doses) can cause side effects such as tooth staining, increased urination, stomach bleeding, uneven heart rate, confusion, and muscle weakness or limp feeling. Read the label of any multivitamin product you take to make sure you are aware of what it contains.

Seek emergency medical attention if you think you have used too much of this medicine. An overdose of vitamins A, D, E, or K can cause serious or life-threatening side effects and can also harm your unborn baby. Certain minerals contained in a prenatal multivitamin may also cause serious overdose symptoms or harm to the baby if you take too much.

Overdose symptoms may include stomach pain, vomiting, diarrhea, constipation, loss of appetite, hair loss, peeling skin, tingly feeling in or around your mouth, changes in menstrual periods, weight loss, severe headache, muscle or joint pain, severe back pain, blood in your urine, pale skin, and easy bruising or bleeding.

Do not take this medication with milk, other dairy products, calcium supplements, or antacids that contain calcium. Calcium may make it harder for your body to absorb certain ingredients of the multivitamin.

What should I discuss with my healthcare provider before taking prenatal vitamins?

Many vitamins can cause serious or life-threatening side effects if taken in large doses. Do not take more of this medication than directed on the label or prescribed by your doctor.

Before taking prenatal vitamins, tell your doctor about all of your medical conditions.

You may need to continue taking prenatal vitamins if you breast-feed your baby. Ask your doctor about taking this medication while breast-feeding.

How should I take prenatal vitamins?

Use exactly as directed on the label, or as prescribed by your doctor. Do not use in larger or smaller amounts or for longer than recommended.

Never take more than the recommended dose of prenatal vitamins.

Many multivitamin products also contain minerals such as calcium, iron, magnesium, potassium, and zinc. Minerals (especially taken in large doses) can cause side effects such as tooth staining, increased urination, stomach bleeding, uneven heart rate, confusion, and muscle weakness or limp feeling. Read the label of any multivitamin product you take to make sure you are aware of what it contains.

Take your prenatal vitamin with a full glass of water.

Swallow the regular tablet or capsule whole. Do not break, chew, crush, or open it.

The chewable tablet must be chewed or allowed to dissolve in your mouth before swallowing. You may also allow the chewable tablet to dissolve in drinking water, fruit juice, or infant formula (but not milk or other dairy products). Drink this mixture right away.

Use prenatal vitamins regularly to get the most benefit. Get your prescription refilled before you run out of medicine completely.

Store at room temperature away from moisture and heat. Keep prenatal vitamins in their original container. Storing vitamins in a glass container can ruin the medication.

What happens if I miss a dose?

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.

What happens if I overdose?

Seek emergency medical attention if you think you have used too much of this medicine. An overdose of vitamins A, D, E, or K can cause serious or life-threatening side effects and can also harm your unborn baby. Certain minerals contained in a prenatal multivitamin may also cause serious overdose symptoms or harm to the baby if you take too much.

Overdose symptoms may include stomach pain, vomiting, diarrhea, constipation, loss of appetite, hair loss, peeling skin, tingly feeling in or around your mouth, changes in menstrual periods, weight loss, severe headache, muscle or joint pain, severe back pain, blood in your urine, pale skin, and easy bruising or bleeding.

What should I avoid while taking prenatal vitamins?

Avoid taking any other multivitamin product within 2 hours before or after you take your prenatal vitamins. Taking similar vitamin products together at the same time can result in a vitamin overdose or serious side effects.

Avoid the regular use of salt substitutes in your diet if your multivitamin contains potassium. If you are on a low-salt diet, ask your doctor before taking a vitamin or mineral supplement.

Do not take this medication with milk, other dairy products, calcium supplements, or antacids that contain calcium. Calcium may make it harder for your body to absorb certain ingredients of the prenatal vitamin.

Prenatal vitamins side effects

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

When taken as directed, prenatal vitamins are not expected to cause serious side effects. Less serious side effects may include:

• 
  

  upset stomach;

  
  


• 
  

  headache; or

  
  


• 
  

  unusual or unpleasant taste in your mouth.

  
  

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What other drugs will affect prenatal vitamins?

Vitamin and mineral supplements can interact with certain medications, or affect how medications work in your body. Before taking a prenatal vitamin, tell your doctor if you also use:

• 
  

  diuretics (water pills);

  
  


• 
  

  heart or blood pressure medications;

  
  


• 
  

  tretinoin (Vesanoid);

  
  


• 
  

  isotretinoin (Accutane, Amnesteen, Clavaris, Sotret);

  
  


• 
  

  trimethoprim and sulfamethoxazole (Cotrim, Bactrim, Gantanol, Gantrisin, Septra, TMP/SMX); or

  
  


• 
  

  an NSAID (non-steroidal anti-inflammatory drug) such as ibuprofen (Advil, Motrin), naproxen (Aleve, Naprosyn, Naprelan, Treximet), celecoxib (Celebrex), diclofenac (Cataflam, Voltaren), indomethacin (Indocin), meloxicam (Mobic), and others.

  
  

This list is not complete and other drugs may interact with prenatal vitamins. Tell your doctor about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal products. Do not start a new medication without telling your doctor.

More Folivan-OB resources

• Folivan-OB Use in Pregnancy & Breastfeeding
• Folivan-OB Drug Interactions
• Folivan-OB Support Group
• 0 Reviews for Folivan-OB - Add your own review/rating

• Cal-Nate MedFacts Consumer Leaflet (Wolters Kluwer)


• CareNatal DHA MedFacts Consumer Leaflet (Wolters Kluwer)


• CitraNatal 90 DHA MedFacts Consumer Leaflet (Wolters Kluwer)


• CitraNatal Assure Prescribing Information (FDA)


• CitraNatal Harmony Prescribing Information (FDA)


• Concept DHA Prescribing Information (FDA)


• Docosavit Prescribing Information (FDA)


• Duet DHA with Ferrazone MedFacts Consumer Leaflet (Wolters Kluwer)


• Folbecal MedFacts Consumer Leaflet (Wolters Kluwer)


• Folcal DHA Prescribing Information (FDA)


• Folcaps Care One Prescribing Information (FDA)


• Gesticare DHA Prescribing Information (FDA)


• Gesticare DHA MedFacts Consumer Leaflet (Wolters Kluwer)


• Inatal Advance Prescribing Information (FDA)


• Inatal Ultra Prescribing Information (FDA)


• Multi-Nate DHA Prescribing Information (FDA)


• Multi-Nate DHA Extra Prescribing Information (FDA)


• MultiNatal Plus MedFacts Consumer Leaflet (Wolters Kluwer)


• Natelle One Prescribing Information (FDA)


• Neevo Caplets MedFacts Consumer Leaflet (Wolters Kluwer)


• Neevo DHA MedFacts Consumer Leaflet (Wolters Kluwer)


• OB Complete 400 MedFacts Consumer Leaflet (Wolters Kluwer)


• Paire OB Plus DHA Prescribing Information (FDA)


• PreNexa MedFacts Consumer Leaflet (Wolters Kluwer)


• PreNexa Prescribing Information (FDA)


• PreferaOB Prescribing Information (FDA)


• Prenatal Plus Prescribing Information (FDA)


• Prenatal Plus Iron Prescribing Information (FDA)


• Prenate Elite Prescribing Information (FDA)


• Prenate Elite MedFacts Consumer Leaflet (Wolters Kluwer)


• Prenate Elite tablets


• Prenate Essential Prescribing Information (FDA)


• PrimaCare Advantage MedFacts Consumer Leaflet (Wolters Kluwer)


• PrimaCare ONE capsules


• PrimaCare One MedFacts Consumer Leaflet (Wolters Kluwer)


• Renate DHA Prescribing Information (FDA)


• Se-Natal 19 Chewable Tablets MedFacts Consumer Leaflet (Wolters Kluwer)


• Se-Natal 19 Prescribing Information (FDA)


• Tandem DHA Prescribing Information (FDA)


• Tandem OB Prescribing Information (FDA)


• TriAdvance Prescribing Information (FDA)


• Triveen-One MedFacts Consumer Leaflet (Wolters Kluwer)


• Triveen-PRx RNF Prescribing Information (FDA)


• UltimateCare ONE NF Prescribing Information (FDA)


• Ultra NatalCare MedFacts Consumer Leaflet (Wolters Kluwer)


• Vinate AZ Prescribing Information (FDA)


• Vitafol-One MedFacts Consumer Leaflet (Wolters Kluwer)


• Zatean-CH Prescribing Information (FDA)

Compare Folivan-OB with other medications

• Vitamin/Mineral Supplementation during Pregnancy/Lactation

Where can I get more information?

• Your pharmacist can provide more information about prenatal vitamins.