PHOSPHASAL- methenamine, sodium phosphate, monobasic, monohydrate, phenyl salicylate, methylene blue, and hyoscyamine sulfate ta

United States - English - NLM (National Library of Medicine)

Buy It Now

Active ingredient:
SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE (UNII: 593YOG76RN) (SODIUM CATION - UNII:LYR4M0NH37), PHENYL SALICYLATE (UNII: 28A37T47QO) (PHENYL SALICYLATE - UNII:28A37T47QO), HYOSCYAMINE SULFATE (UNII: F2R8V82B84) (HYOSCYAMINE - UNII:PX44XO846X), METHYLENE BLUE (UNII: T42P99266K) (METHYLENE BLUE CATION - UNII:ZMZ79891ZH), METHENAMINE (UNII: J50OIX95QV) (METHENAMINE - UNII:J50OIX95QV)
Available from:
BioComp Pharma
Administration route:
ORAL
Prescription type:
PRESCRIPTION DRUG
Therapeutic indications:
Phosphasal ® tablets are indicated for the treatment of symptoms of irritative voiding. Indicated for the relief of local symptoms, such as inflammation, hypermotility, and pain, which accompany lower urinary tract infections. Indicated for the relief of urinary tract symptoms caused by diagnostic procedures. Hypersensitivity to any of the ingredients is possible. Risk benefits should be carefully considered when the following medical problems exist: cardiac disease (especially cardiac arrhythmias, congestive heart failure, coronary heart disease, and mitral stenosis); gastrointestinal tract obstructive disease; glaucoma; myasthenia gravis, acute urinary retention may be precipitated in obstructive uropathy (such as bladder neck obstruction due to prostatic hypertrophy). A dependence on the use of Phosphasal ® tablets has not been reported and due to the nature of its ingredients, abuse of Phosphasal ® tablets is not expected.
Product summary:
Phosphasal ® tablets are blue tablets imprinted with "SAT" on one side and "902" on opposite side. NDC 44523-742-01, Bottle of 100 Tablets. Dispense in a tight, light-resistant container as defined in the USP/NF with a child resistant closure. Store at controlled room temperature 15°-30°C (59°-86°F). Keep in a cool, dry place. Keep container tightly closed.
Authorization status:
unapproved drug other
Authorization number:
44523-742-01

PHOSPHASAL- methenamine, sodium phosphate, monobasic, monohydrate, phenyl salicylate,

methylene blue, and hyoscyamine sulfate tablet

BioComp Pharma

Disclaimer: This drug has not been found by FDA to be safe and effective, and this labeling has not been

approved by FDA. For further information about unapproved drugs, click here.

----------

Phosphasal

Rx Only

100 Tablets

DESCRIPTION

Phosphasal

tablets for oral administration

Each tablet contains:

Methenamine

81.6 mg

Sodium Phosphate Monobasic

40.8 mg

Phenyl Salicylate

36.2 mg

Methylene Blue

10.8 mg

Hyoscyamine Sulfate

0.12 mg

HYOSCYAMINE SULFATE. [620-61-1][3(S)-endo]-α-(Hydroxymethyl)-benzeneacetic acid 8-methyl-

8-azabicyclo[3.2.1]oct-3-yl ester sulfate(2:1)(salt); 1αH,5αH-tropan-3α-ol(-)-tropate(ester)

sulfate(2:1)(salt);3α-tropanyl S-(-)-tropate; l-tropic acid ester with tropine; l-tropine tropate. C

S. Hyoscyamine Sulfate is an alkaloid of belladonna. Exists as a white crystalline powder. Its

solutions are alkaline to litmus. Affected by light, it is slightly soluble in water; freely soluble in

alcohol; sparingly soluble in ether.

METHENAMINE. [100-97-0] 1,3,5,7-Tetraazatricyclo [3.3.1.-1

] decane; hexamethylenetetramine;

HMT; HMTA; hexamine; 1,3,5,7-tetraazaadamantane hexamethylenemine; Uritone; Urotropin. C

; mol wt 140.19; C 51.40%, H 8.63%, N 39.96%. Methenamine (hexamethylenetetramine) exists as

colorless, lustrous crystals or white crystalline powder. Its solutions are alkaline to litmus. Freely

soluble in water, soluble in alcohol and in chloroform.

METHYLENE BLUE. [61-73-4] 3,7-Bis(dimethylamino) phenothiazin-5-ium chloride; C.I. Basic Blue

9; methylthioninium chloride; tetramethylthionine chloride; 3,7-bis(dimethylamino) phenazathionium

chloride. C

S; mol wt 319.85, C 60.08%, H 5.67%, Cl 11.08%, N 13.14%, S 10.03%.

Methylene Blue (Methylthionine chloride) exists as dark green crystals. It is soluble in water and in

chloroform; sparingly soluble in alcohol.

PHENYL SALICYLATE. [118-55-8] 2-Hydroxybenzoic acid phenyl ester; Salol. C

; mol wt

214.22, C 72.89%, H 4.71%, O 22.41%. Made by the action of phosphorus oxy-chloride on a mixture

of phenol and salicylic acid. Phenyl Salicylate exists as white crystals with a melting point of 41°-43°

C. It is very slightly soluble in water and freely soluble in alcohol.

SODIUM PHOSPHATE MONOBASIC. [7558-80-7] Phosphoric acid sodium salt (1:1); Sodium

biphosphate; sodium dihydrogen phosphate; acid sodium phosphate; monosodium orthophosphate;

primary sodium phosphate; H

P; mol wt 119.98, H 1.68%, Na 19.16%, O 53.34%, P 25.82%.

Monohydrate, white, odorless slightly deliquesce crystals or granules. At 100° C loses all its water;

when ignited it converts to metaphosphate. It is freely soluble in water and practically insoluble in

alcohol. The aqueous solution is acid. pH of 0.1 molar aqueous solution at 25° C: 4.5.

®

®

®

Phosphasal

tablets contain inactive ingredients: Crospovidone, Dicalcium Phosphate, FD&C Blue #1

Aluminum Lake, Magnesium Stearate, Microcrystalline Cellulose, Polyethylene Glycol, Polyvinyl

Alcohol, Stearic Acid, Talc, and Titanium Dioxide.

CLINICAL PHARMACOLOGY

HYOSCYAMINE SULFATE is a parasympatholytic which relaxes smooth muscles and thus produces

an antispasmodic effect. It is well absorbed from the gastrointestinal tract and is rapidly distributed

throughout the body tissues. Most is excreted in the urine within 12 hours, 13% to 50% being

unchanged. Its biotransformation is hepatic. Its protein binding is moderate.

METHENAMINE degrades in an acidic urine environment releasing formaldehyde which provides

bactericidal or bacteriostatic action. It is well absorbed from the gastrointestinal tract. 70%-90%

reaches the urine unchanged at which point it is hydrolyzed if the urine is acidic. Within 24 hours it is

almost completely (90%) excreted; of this at a pH of 5, approximately 20% is formaldehyde. Protein

binding - some formaldehyde is bound to substances in the urine and surrounding tissues. Methenamine

is freely distributed to body tissue and fluids but is not clinically significant as it does not hydrolyze at

pH greater than 6.8.

METHYLENE BLUE possesses weak antiseptic properties. It is well absorbed by the gastrointestinal

tract and rapidly reduced to leukomethylene blue which is stabilizied in some combination form in the

urine. 75% is excreted unchanged.

PHENYL SALICYLATE releases salicylate, a mild analgesic for pain.

SODIUM PHOSPHATE MONOBASIC an acidifier, helps to maintain an acid pH in the urine necessary

for the degradation of methenamine.

INDICATIONS AND USAGE

Phosphasal

tablets are indicated for the treatment of symptoms of irritative voiding. Indicated for the

relief of local symptoms, such as inflammation, hypermotility, and pain, which accompany lower urinary

tract infections. Indicated for the relief of urinary tract symptoms caused by diagnostic procedures.

CONTRAINDICATIONS

Hypersensitivity to any of the ingredients is possible.

Risk benefits should be carefully considered when the following medical problems exist: cardiac

disease (especially cardiac arrhythmias, congestive heart failure, coronary heart disease, and mitral

stenosis); gastrointestinal tract obstructive disease; glaucoma; myasthenia gravis, acute urinary retention

may be precipitated in obstructive uropathy (such as bladder neck obstruction due to prostatic

hypertrophy).

WARNINGS

Do not exceed recommended dosage. If rapid pulse, dizziness or blurring of vision occurs discontinue

use immediately.

PRECAUTIONS

Cross sensitivity and/or related problems

patients intolerant of belladonna alkaloids or salicylates may be intolerant of this medication also. Delay

in gastric emptying could complicate the management of gastric ulcers.

®

®

Pregnancy/Reproduction

FDA Pregnancy Category C

hyoscyamine and methenamine cross the placenta. Studies concerning the effect of hyoscyamine and

methenamine on pregnancy and reproduction have not been done in animals or humans. Thus it is not

known whether Phosphasal

tablets cause fetal harm when administered to a pregnant woman or can

affect reproduction capacity and should be given to a pregnant woman only if clearly needed.

Breast feeding

problems in humans have not been documented; however, methenamine and traces of hyoscyamine are

excreted in breast milk. Accordingly, Phosphasal

tablets should be given to a nursing mother with

caution and only if clearly needed.

Prolonged use

there have been no studies to establish the safety of prolonged use in humans. No known long-term

animal studies have been performed to valuate carcinogenic potential.

Pediatric

infants and young children are especially susceptible to the toxic effect of the belladonna alkaloids.

Geriatric Use

use with caution in elderly patients as they may respond to usual doses of hyoscyamine with excitement,

agitation, drowsiness or confusion.

ADVERSE REACTIONS

Cardiovascular: rapid heartbeat, flushing

Central Nervous System: blurred vision, dizziness, drowsiness

Genitourinary: difficult micturition, acute urinary retention

Gastrointestinal: dry mouth, nausea and vomiting

Respiratory: shortness of breath or trouble breathing

Serious allergic reactions to this drug are rare. Seek immediate medical attention if you notice

symptoms of a serious allergic reaction, including itching, rash, severe dizziness, swelling or trouble

breathing.

This medication can cause urine and sometimes stools to turn blue to blue-green. This effect is

harmless and will subside after medication is stopped.

Call your doctor or physician for medical advice about side effects. To report SUSPECTED

ADVERSE REACTIONS, contact BioComp Pharma at 1-866-762-2365 or FDA at 1-800-FDA-

1088, www.fda.gov/medwatch.

Drug interactions

because of this product's effect on gastrointestinal motility and gastric emptying, it may decrease the

absorption of other oral medications during concurrent use such as: urinary alkalizers; thiazide diuretics

(may cause the urine to become alkaline reducing the effectiveness of methenamine by inhibiting its

conversion to formaldehyde); antimuscarinics (concurrent use may intensify antimuscarinic effects of

hyoscyamine because of secondary antimuscarinic activities of these medications);

antacids/antidiarrheals (may reduce absorption of hyoscyamine, concurrent use with antacids may cause

urine to become alkaline, reducing effectiveness of methenamine by inhibiting its conversion to

®

®

formaldehyde). Doses of these medications should be spaced 1 hour apart from doses of hyoscyamine;

antimyasthenics (concurrent use with hyoscyamine may further reduce intestinal motility); ketoconazole

(patients should be advised to take this combination at least 2 hours after ketoconazole); monoamine

oxidase (MAO) inhibitors (concurrent use may intensify antimuscarinic side effects), opioid (narcotic

analgesics may result in increased risk of severe constipation); sulfonamides (these drugs may

precipitate with formaldehyde in the urine, increasing the danger of crystalluria). Patients should be

advised that the urine may become blue to blue-green and the feces may be discolored as a result of the

excretion of the Methylene blue.

DRUG ABUSE AND DEPENDENCE

A dependence on the use of Phosphasal

tablets has not been reported and due to the nature of its

ingredients, abuse of Phosphasal

tablets is not expected.

OVERDOSAGE

Emesis or gastric lavage. Slow intravenous administration of physostigmine in doses of 1 to 4 mg (0.5

to 1 mg in children), repeated as needed in one to two hours to reverse severe antimuscarinic symptoms.

Administration of small doses of diazepam to control excitement and seizures. Artificial respiration

with oxygen if needed for respiratory depression. Adequate hydration. Symptomatic treatment as

necessary.

If overdose is suspected, contact your local poison center or emergency room immediately. US

residents can contact the US National Poison Hotline at 1-800-222-1222.

HOW SUPPLIED

Phosphasal

tablets are blue tablets imprinted with "SAT" on one side and "902" on opposite side.

NDC 44523-742-01, Bottle of 100 Tablets.

STORAGE

Dispense in a tight, light-resistant container as defined in the USP/NF with a child resistant closure.

Store at controlled room temperature 15°-30°C (59°-86°F).

Keep in a cool, dry place.

Keep container tightly closed.

DOSAGE AND ADMINISTRATION

Adults - one tablet orally 4 times per day followed by liberal fluid intake.

Older Children - Dosage must be individualized by physician. Not recommended for use in children

six years of age or younger.

Phosphasal Bottle Label

®

®

®

WARNING: Keep this and all drugs out of reach of children.

Rx Only

Distributed by:

BIOCOMP PHARMA, INC.

San Antonio, Texas 78230

PHOSPHASAL

methenamine, sodium phosphate, monobasic, monohydrate, phenyl salicylate, methylene blue, and hyoscyamine

sulfate tablet

Product Information

Product T ype

HUMAN PRESCRIPTION DRUG

Ite m Code (Source )

NDC:44523-742

Route of Administration

ORAL

Active Ingredient/Active Moiety

Ingredient Name

Basis of Strength

Stre ng th

SO DIUM PHO SPHATE, MO NO BASIC, MO NO HYDRATE (UNII: 59 3YOG76 RN)

(SODIUM CATION - UNII:LYR4M0 NH37)

SODIUM PHOSPHATE, MONOBASIC,

MONOHYDRATE

40 .8 mg

PHENYL SALICYLATE (UNII: 28 A37T47QO) (PHENYL SALICYLATE -

UNII:28 A37T47QO)

PHENYL SALICYLATE

36 .2 mg

HYO SCYAMINE SULFATE (UNII: F2R8 V8 2B8 4) (HYOSCYAMINE -

UNII:PX44XO8 46 X)

HYOSCYAMINE SULFATE

0 .12 mg

METHYLENE BLUE (UNII: T42P9 9 26 6 K) (METHYLENE BLUE CATION -

UNII:ZMZ79 8 9 1ZH)

METHYLENE BLUE

10 .8 mg

METHENAMINE (UNII: J50 OIX9 5QV) (METHENAMINE - UNII:J50 OIX9 5QV)

METHENAMINE

8 1.6 mg

BioComp Pharma

Inactive Ingredients

Ingredient Name

Stre ng th

CRO SPO VIDO NE (UNII: 6 8 40 19 6 0 MK)

ANHYDRO US DIBASIC CALCIUM PHO SPHATE (UNII: L11K75P9 2J)

ALUMINUM O XIDE (UNII: LMI26 O6 9 33)

MAGNESIUM STEARATE (UNII: 70 0 9 7M6 I30 )

CELLULO SE, MICRO CRYSTALLINE (UNII: OP1R32D6 1U)

PO LYETHYLENE GLYCO L (UNII: 3WJQ0 SDW1A)

PO LYVINYL ALCO HO L (UNII: 532B59 J9 9 0 )

STEARIC ACID (UNII: 4ELV7Z6 5AP)

TALC (UNII: 7SEV7J4R1U)

TITANIUM DIO XIDE (UNII: 15FIX9 V2JP)

Product Characteristics

Color

blue

S core

no sco re

S hap e

OVAL

S iz e

12mm

Flavor

Imprint Code

SAT;9 0 2

Contains

Packag ing

#

Item Code

Package Description

Marketing Start Date

Marketing End Date

1

NDC:44523-742-0 1

10 0 in 1 BOTTLE; Type 0 : No t a Co mbinatio n Pro duct

0 9 /21/20 10

Marketing Information

Marke ting Cate gory

Application Numbe r or Monograph Citation

Marke ting Start Date

Marke ting End Date

unappro ved drug o ther

0 9 /21/20 10

Labeler -

BioComp Pharma (829249718)

Revised: 8/2019

Similar products

Search alerts related to this product

View documents history

Share this information