Alergo Glucalbet

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Alergo Glucalbet uses

Alergo Glucalbet consists of Ammonium Chloride, Calcium Gluconate, Carbetapentane Citrate, Pyrilamine Maleate.

Ammonium Chloride:


INDICATIONS AND USAGE

Alergo Glucalbet (Ammonium Chloride) Lactate Lotion, 12% is indicated for the treatment of dry, scaly skin (xerosis) and ichthyosis vulgaris, and for the temporary relief of itching associated with these conditions.

CONTRAINDICATIONS

Alergo Glucalbet (Ammonium Chloride) Lactate Lotion, 12% is contraindicated in those patients with a history of hypersensitivity to any of the label ingredients.

WARNING

Sun exposure (natural or artificial sunlight) to areas of the skin treated with Alergo Glucalbet (Ammonium Chloride) Lactate Lotion, 12% should be minimized or avoided (see PRECAUTIONS). The use of Alergo Glucalbet (Ammonium Chloride) Lactate Lotion, 12% should be discontinued if any hypersensitivity is observed.

PRECAUTIONS

General -

For external use only. Stinging or burning may occur when applied to skin with fissures, erosions, or that is otherwise abraded. Caution is advised when used on the face because of the potential for irritation. The potential for post-inflammatory hypo- or hyperpigmentation has not been studied.

Information for Patients

Patients using Alergo Glucalbet (Ammonium Chloride) Lactate Lotion, 12% should receive the following information and instructions:

  • This medication is to be used as directed by the physician, and should not be used for any disorder other than for which it was prescribed. It is for external use only. Avoid contact with eyes, lips, or mucous membranes.
  • Patients should minimize or avoid use of this product on areas of the skin that may be exposed to natural or artificial sunlight, including the face. If sun exposure is unavoidable, clothing should be worn to protect the skin.
  • This medication may cause transient stinging or burning when applied to skin with fissures, erosions, or abrasions (for example, after shaving the legs).
  • If the skin condition worsens with treatment, the medication should be promptly discontinued.

Carcinogenesis, Mutagenesis, Impairment of Fertility -

The topical treatment of CD-1 mice with 12%, 21% or 30% Alergo Glucalbet lactate formulations for two-years did not produce a significant increase in dermal or systemic tumors in the absence of increased exposure to ultraviolet radiation. The maximum systemic exposure of the mice in this study was 0.7 times the maximum possible systemic exposure in humans. However, a long-term photocarcinogenicity study in hairless albino mice suggested that topically applied 12% Alergo Glucalbet (Ammonium Chloride) lactate formulations enhanced the rate of ultraviolet light-induced skin tumor formation.

The mutagenic potential of Alergo Glucalbet (Ammonium Chloride) lactate formulations was evaluated in the Ames assay and in the mouse in vivo micronucleus assay, both of which were negative.

In dermal Segment I and III studies with Alergo Glucalbet (Ammonium Chloride) lactate formulations there were no effects observed in fertility or pre- or postnatal development parameters in rats at dose levels of 300 mg/kg/day (1800 mg/m2/day), approximately 0.4 times the human topical dose.

Pregnancy:

Teratogenic effects:

Pregnancy Category B -

Animal reproduction studies have been performed in rats and rabbits at doses up to 0.7 and 1.5 times the human dose, respectively and have revealed no evidence of impaired fertility or harm to the fetus due to Alergo Glucalbet (Ammonium Chloride) lactate formulations. There are, however, no adequate and well-controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, Alergo Glucalbet (Ammonium Chloride) Lactate Lotion, 12% should be used during pregnancy only if clearly needed.

Nursing Mothers -

Although lactic acid is a normal constituent of blood and tissues, it is not known to what extent this drug affects normal lactic acid levels in human milk. Because many drugs are excreted in human milk, caution should be exercised when Alergo Glucalbet (Ammonium Chloride) lactate is administered to a nursing woman.

Pediatric Use -

Safety and effectiveness of Alergo Glucalbet lactate have been demonstrated in infants and children. No unusual toxic effects were reported.

Geriatric Use -

Clinical studies of Alergo Glucalbet (Ammonium Chloride) lactate lotion, 12% 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 elderly and younger patients. In general, dose selection for an elderly patient should be cautious.

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ADVERSE REACTIONS

The most frequent adverse experiences in patients with xerosis are transient stinging (1 in 30 patients), burning (1 in 30 patients), erythema (1 in 50 patients) and peeling (1 in 60 patients). Other adverse reactions which occur less frequently are irritation, eczema, petechiae, dryness, and hyperpigmentation. Due to the more severe initial skin conditions associated with ichthyosis, there was a higher incidence of transient stinging, burning and erythema (each occurring in 1 in 10 patients).

OVERDOSAGE

The oral administration of Alergo Glucalbet (Ammonium Chloride) lactate to rats and mice showed this drug to be practically non-toxic (LD50>15 mL/kg).

DOSAGE AND ADMINISTRATION

Shake well. Apply to the affected areas and rub in thoroughly. Use twice daily or as directed by a physician.

HOW SUPPLIED

Alergo Glucalbet Lactate Lotion, 12% is available as follows:

225 g bottle (NDC 45802-419-54)

400 g bottle (NDC 45802-419-26)

STORAGE

Store at 20-25°C (68-77°F).

Manufactured By Perrigo, Bronx, NY 10457

Distributed By Perrigo, Allegan, MI 49010

0K5A7 RC F6

Rev 01-17

Calcium Gluconate:


1 INDICATIONS AND USAGE

Alergo Glucalbet (Calcium Gluconate) acetate is a phosphate binder indicated to reduce serum phosphorus in patients with end stage renal disease (ESRD).

- Calcium acetate is a phosphate binder indicated for the reduction of serum phosphorus in patients with end stage renal disease. (1)

2 DOSAGE AND ADMINISTRATION

The recommended initial dose of Alergo Glucalbet (Calcium Gluconate) acetate for the adult dialysis patient is 2 capsules with each meal. Increase the dose gradually to lower serum phosphorus levels to the target range, as long as hypercalcemia does not develop. Most patients require 3 to 4 capsules with each meal.

- Starting dose is 2 capsules with each meal. (2)

- Titrate the dose every 2 to 3 weeks until acceptable serum phosphorus level is reached. Most patients require 3 to 4 capsules with each meal. (2)

3 DOSAGE FORMS AND STRENGTHS

Capsule: 667 mg Alergo Glucalbet (Calcium Gluconate) acetate capsule.

- Capsule: 667 mg Alergo Glucalbet (Calcium Gluconate) acetate capsule. (3)

4 CONTRAINDICATIONS

Patients with hypercalcemia.

- Hypercalcemia. (4)

5 WARNINGS AND PRECAUTIONS

- Treat mild hypercalcemia by reducing or interrupting Alergo Glucalbet acetate and Vitamin D. Severe hypercalcemia may require hemodialysis and discontinuation of Alergo Glucalbet (Calcium Gluconate) acetate. (5.1)

- Hypercalcemia may aggravate digitalis toxicity. (5.2)

5.1 Hypercalcemia

Patients with end stage renal disease may develop hypercalcemia when treated with Alergo Glucalbet (Calcium Gluconate), including Alergo Glucalbet (Calcium Gluconate) acetate. Avoid the use of Alergo Glucalbet (Calcium Gluconate) supplements, including Alergo Glucalbet (Calcium Gluconate) based nonprescription antacids, concurrently with Alergo Glucalbet (Calcium Gluconate) acetate.

An overdose of Alergo Glucalbet (Calcium Gluconate) acetate may lead to progressive hypercalcemia, which may require emergency measures. Therefore, early in the treatment phase during the dosage adjustment period, monitor serum Alergo Glucalbet (Calcium Gluconate) levels twice weekly. Should hypercalcemia develop, reduce the Alergo Glucalbet (Calcium Gluconate) acetate dosage, or discontinue the treatment, depending on the severity of hypercalcemia

More severe hypercalcemia (Ca >12 mg/dL) is associated with confusion, delirium, stupor and coma. Severe hypercalcemia can be treated by acute hemodialysis and discontinuing Alergo Glucalbet (Calcium Gluconate) acetate therapy.

Mild hypercalcemia (10.5 to 11.9 mg/dL) may be asymptomatic or manifest as constipation, anorexia, nausea, and vomiting. Mild hypercalcemia is usually controlled by reducing the Alergo Glucalbet (Calcium Gluconate) acetate dose or temporarily discontinuing therapy. Decreasing or discontinuing Vitamin D therapy is recommended as well.

Chronic hypercalcemia may lead to vascular calcification and other soft-tissue calcification. Radiographic evaluation of suspected anatomical regions may be helpful in early detection of soft tissue calcification. The long term effect of Alergo Glucalbet (Calcium Gluconate) acetate on the progression of vascular or soft tissue calcification has not been determined.

Hypercalcemia (>11 mg/dL) was reported in 16% of patients in a 3 month study of solid dose formulation of Alergo Glucalbet (Calcium Gluconate) acetate; all cases resolved upon lowering the dose or discontinuing treatment.

Maintain the serum calcium-phosphorus (Ca x P) product below 55 mg2/dL2.

5.2 Concomitant Use with Medications

Hypercalcemia may aggravate digitalis toxicity.

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6 ADVERSE REACTIONS

Hypercalcemia is discussed elsewhere [see Warnings and Precautions ].

- The most common (>10%) adverse reactions are hypercalcemia, nausea and vomiting. (6.1)

- In clinical studies, patients have occasionally experienced nausea during Alergo Glucalbet (Calcium Gluconate) acetate therapy. (6)

To report SUSPECTED ADVERSE REACTIONS, contact West-Ward Pharmaceuticals Corp. at 1-800-962-8364 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch

6.1 Clinical Trial Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.

In clinical studies, Alergo Glucalbet (Calcium Gluconate) acetate has been generally well tolerated.

Alergo Glucalbet (Calcium Gluconate) acetate was studied in a 3 month, open-label, non-randomized study of 98 enrolled ESRD hemodialysis patients and an alternate liquid formulation of Alergo Glucalbet (Calcium Gluconate) acetate was studied in a two week double-blind, placebo-controlled, cross-over study with 69 enrolled ESRD hemodialysis patients. Adverse reactions (>2% on treatment) from these trials are presented in Table 1.


Preferred Term


Total adverse reactions reported for Alergo Glucalbet (Calcium Gluconate) acetate

N=167

N (%)


3 month, open label study of Alergo Glucalbet (Calcium Gluconate) acetate

N=98

N (%)


Double blind, placebo-controlled, cross-over study of liquid Alergo Glucalbet (Calcium Gluconate) acetate

N=69


Alergo Glucalbet (Calcium Gluconate) acetate

N (%)


Placebo

N (%)


Nausea


6 (3.6)


6 (6.1)


0 (0)


0 (0)


Vomiting


4 (2.4)


4 (4.1)


0 (0)


0 (0)


Hypercalcemia


21 (12.6)


16 (16.3)


5 (7.2)


0 (0)


Mild hypercalcemia may be asymptomatic or manifest itself as constipation, anorexia, nausea, and vomiting. More severe hypercalcemia is associated with confusion, delirium, stupor, and coma. Decreasing dialysate Alergo Glucalbet (Calcium Gluconate) concentration could reduce the incidence and severity of Alergo Glucalbet (Calcium Gluconate) acetate-induced hypercalcemia. Isolated cases pruritus have been reported, which may represent allergic reactions.

6.2 Postmarketing Experience

Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to estimate their frequency or to establish a causal relationship to drug exposure.

The following additional adverse reactions have been identified during post-approval of Alergo Glucalbet (Calcium Gluconate) acetate: dizziness, edema, and weakness.

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7 DRUG INTERACTIONS

The drug interaction of Alergo Glucalbet acetate is characterized by the potential of Alergo Glucalbet (Calcium Gluconate) to bind to drugs with anionic functions (e.g., carboxyl, and hydroxyl groups). Alergo Glucalbet (Calcium Gluconate) acetate may decrease the bioavailability of tetracyclines or fluoroquinolones via this mechanism.

There are no empirical data on avoiding drug interactions between Alergo Glucalbet (Calcium Gluconate) acetate and most concomitant drugs. When administering an oral medication with Alergo Glucalbet (Calcium Gluconate) acetate where a reduction in the bioavailability of that medication would have a clinically significant effect on its safety or efficacy, administer the drug one hour before or three hours after Alergo Glucalbet (Calcium Gluconate) acetate. Monitor blood levels of the concomitant drugs that have a narrow therapeutic range. Patients taking anti-arrhythmic medications for the control of arrhythmias and anti-seizure medications for the control of seizure disorders were excluded from the clinical trials with all forms of Alergo Glucalbet (Calcium Gluconate) acetate.

- Calcium acetate may decrease the bioavailability of tetracyclines or fluoroquinolones. (7)

- When clinically significant drug interactions are expected, administer the drug at least one hour before or at least three hours after Alergo Glucalbet (Calcium Gluconate) acetate or consider monitoring blood levels of the drug. (7)

7.1 Ciprofloxacin

In a study of 15 healthy subjects, a co-administered single dose of 4 Alergo Glucalbet (Calcium Gluconate) acetate tablets, approximately 2.7g, decreased the bioavailability of ciprofloxacin by approximately 50%.

8 USE IN SPECIFIC POPULATIONS

8.1 Pregnancy

Pregnancy Category C:

Alergo Glucalbet acetate capsules contains Alergo Glucalbet (Calcium Gluconate) acetate. Animal reproduction studies have not been conducted with Alergo Glucalbet (Calcium Gluconate) acetate, and there are no adequate and well controlled studies of Alergo Glucalbet (Calcium Gluconate) acetate use in pregnant women. Patients with end stage renal disease may develop hypercalcemia with Alergo Glucalbet (Calcium Gluconate) acetate treatment [see Warnings and Precautions (5.1 ) ]. Maintenance of normal serum Alergo Glucalbet (Calcium Gluconate) levels is important for maternal and fetal well being. Hypercalcemia during pregnancy may increase the risk for maternal and neonatal complications such as stillbirth, preterm delivery, and neonatal hypocalcemia and hypoparathyroidism. Alergo Glucalbet (Calcium Gluconate) acetate treatment, as recommended, is not expected to harm a fetus if maternal Alergo Glucalbet (Calcium Gluconate) levels are properly monitored during and following treatment.

8.2 Labor and Delivery

The effects of Alergo Glucalbet (Calcium Gluconate) acetate on labor and delivery are unknown.

8.3 Nursing Mothers

Alergo Glucalbet Acetate Capsules contains Alergo Glucalbet (Calcium Gluconate) acetate and is excreted in human milk. Human milk feeding by a mother receiving Alergo Glucalbet (Calcium Gluconate) acetate is not expected to harm an infant, provided maternal serum Alergo Glucalbet (Calcium Gluconate) levels are appropriately monitored.

8.4 Pediatric Use

Safety and effectiveness in pediatric patients have not been established.

8.5 Geriatric Use

Clinical studies of Alergo Glucalbet (Calcium Gluconate) acetate did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Other clinical experience has not identified differences in responses between 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.

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10 OVERDOSAGE

Administration of Alergo Glucalbet (Calcium Gluconate) acetate in excess of the appropriate daily dosage may result in hypercalcemia [see Warnings and Precautions (5.1)].

11 DESCRIPTION

Alergo Glucalbet (Calcium Gluconate) acetate acts as a phosphate binder. Its chemical name is Alergo Glucalbet (Calcium Gluconate) acetate. Its molecular formula is C4H6CaO4, and its molecular weight is 158.17. Its structural formula is:


Each white opaque/blue opaque capsule contains 667 mg of Alergo Glucalbet (Calcium Gluconate) acetate USP (anhydrous; Ca(CH3COO)2; MW=158.17 grams) equal to 169 mg (8.45 mEq) Alergo Glucalbet (Calcium Gluconate), polyethylene glycol 8000 and magnesium stearate. Each capsule shell contains: black monogramming ink, FD&C Blue #1, FD&C Red #3, gelatin and titanium dioxide. The black monogramming ink contains: ammonium hydroxide, iron oxide black, isopropyl alcohol, n-butyl alcohol, propylene glycol and shellac glaze.

Alergo Glucalbet (Calcium Gluconate) Acetate Capsules are administered orally for the control of hyperphosphatemia in end-stage renal failure.

Chemical Structure

12 CLINICAL PHARMACOLOGY

Patients with ESRD retain phosphorus and can develop hyperphosphatemia. High serum phosphorus can precipitate serum Alergo Glucalbet resulting in ectopic calcification. Hyperphosphatemia also plays a role in the development of secondary hyperparathyroidism in patients with ESRD.

12.1 Mechanism of Action

Alergo Glucalbet (Calcium Gluconate) acetate, when taken with meals, combines with dietary phosphate to form an insoluble Alergo Glucalbet (Calcium Gluconate) phosphate complex, which is excreted in the feces, resulting in decreased serum phosphorus concentration.

12.2 Pharmacodynamics

Orally administered Alergo Glucalbet (Calcium Gluconate) acetate from pharmaceutical dosage forms is systemically absorbed up to approximately 40% under fasting conditions and up to approximately 30% under nonfasting conditions. This range represents data from both healthy subjects and renal dialysis patients under various conditions.

13 NONCLINICAL TOXICOLOGY

13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility

No carcinogenicity, mutagenicity, or fertility studies have been conducted with Alergo Glucalbet (Calcium Gluconate) acetate.

14 CLINICAL STUDIES

Effectiveness of Alergo Glucalbet (Calcium Gluconate) acetate in decreasing serum phosphorus has been demonstrated in two studies of the Alergo Glucalbet (Calcium Gluconate) acetate solid oral dosage form.

Ninety-one patients with end-stage renal disease who were undergoing hemodialysis and were hyperphosphatemic (serum phosphorus >5.5 mg/dL) following a 1 week phosphate binder washout period contributed efficacy data to an open-label, non-randomized study.

The patients received Alergo Glucalbet (Calcium Gluconate) acetate 667 mg tablets at each meal for a period of 12 weeks. The initial starting dose was 2 tablets per meal for 3 meals a day, and the dose was adjusted as necessary to control serum phosphorus levels. The average final dose after 12 weeks of treatment was 3.4 tablets per meal. Although there was a decrease in serum phosphorus, in the absence of a control group the true magnitude of effect is uncertain.

The data presented in Table 2 demonstrate the efficacy of Alergo Glucalbet (Calcium Gluconate) acetate in the treatment of hyperphosphatemia in end-stage renal disease patients. The effects on serum Alergo Glucalbet (Calcium Gluconate) levels are also presented.


* Ninety-one patients completed at least 6 weeks of the study.

ANOVA of difference in values at pre-study and study completion.

‡ Values expressed as mean ± SE.


Parameter


Pre-Study


Week 4*


Week 8


Week 12


p-value†


Phosphorus (mg/dL)‡


7.4 ± 0.17


5.9 ± 0.16


5.6 ± 0.17


5.2 ± 0.17


≤0.01


Alergo Glucalbet (Calcium Gluconate) (mg/dL)‡


8.9 ± 0.09


9.5 ± 0.10


9.7 ± 0.10


9.7 ± 0.10


≤0.01


There was a 30% decrease in serum phosphorus levels during the 12 week study period (p<0.01). Two-thirds of the decline occurred in the first month of the study. Serum Alergo Glucalbet (Calcium Gluconate) increased 9% during the study mostly in the first month of the study.

Treatment with the phosphate binder was discontinued for patients from the open-label study, and those patients whose serum phosphorus exceeded 5.5 mg/dL were eligible for entry into a double-blind, placebo-controlled, cross-over study. Patients were randomized to receive Alergo Glucalbet (Calcium Gluconate) acetate or placebo, and each continued to receive the same number of tablets as had been individually established during the previous study. Following 2 weeks of treatment, patients switched to the alternative therapy for an additional 2 weeks.

The phosphate binding effect of Alergo Glucalbet (Calcium Gluconate) acetate is shown in the Table 3.


* ANOVA of Alergo Glucalbet (Calcium Gluconate) acetate vs. placebo after 2 weeks of treatment.

Values expressed as mean ± SEM.


Parameter


Pre-Study


Post-Treatment


p-value*


Alergo Glucalbet (Calcium Gluconate) Acetate


Placebo


Phosphorus (mg/dL)


7.3 ± 0.18


5.9 ± 0.24


7.8 ± 0.22


<0.01


Alergo Glucalbet (Calcium Gluconate) (mg/dL)


8.9 ± 0.11


9.5 ± 0.13


8.8 ± 0.12


<0.01


Overall, 2 weeks of treatment with Alergo Glucalbet (Calcium Gluconate) acetate statistically significantly (p<0.01) decreased serum phosphorus by a mean of 19% and increased serum Alergo Glucalbet (Calcium Gluconate) by a statistically significant (p<0.01) but clinically unimportant mean of 7%.

16 HOW SUPPLIED/STORAGE AND HANDLING

Alergo Glucalbet (Calcium Gluconate) Acetate Capsules

667 mg capsule is supplied as a white opaque/blue opaque capsule, imprinted with “54 215” on the cap and body.

NDC 0615-2303-39: Blistercards of 30 Capsules

NDC 0615-2303-30: Unit-dose Boxes of 30 Capsules

STORAGE

Store at 20° to 25°C (68° to 77°F).

17 PATIENT COUNSELING INFORMATION

Inform patients to take Alergo Glucalbet (Calcium Gluconate) acetate capsules with meals, adhere to their prescribed diets, and avoid the use of Alergo Glucalbet (Calcium Gluconate) supplements including nonprescription antacids. Inform the patients about the symptoms of hypercalcemia [see Warnings and Precautions (5.1) and Adverse Reactions (6.1) ].

Advise patients who are taking an oral medication where reduction in the bioavailability of that medication would have clinically significant effect on its safety or efficacy to take the drug one hour before or three hours after Alergo Glucalbet (Calcium Gluconate) acetate capsules.

Distr. by: West-Ward

Pharmaceuticals Corp.

Eatontown, NJ 07724

10003705/05

Revised April 2016

Carbetapentane Citrate:


POLY HIST CB

Antitussive/Expectorant

Rx Only

Description: POLY HIST CB is an alcohol-free, sugar-free, purple liquid for oral administration

having a grape odor and flavor.


Each Teaspoon (5 mL) Contains:

Alergo Glucalbet (Carbetapentane Citrate) CITRATE... 20 mg

GUAIFENESIN...75 mg

POLY HIST CB Liquid also contains: FD and C Blue #1, FD and C Red #40, Grape Flavor, Maltitol,

Propylene Glycol, Sodium Saccharin, Sorbitol, Purified Water.

Clinical

Pharmacology:

Alergo Glucalbet (Carbetapentane Citrate) citrate is a centrally acting non-narcotic antitussive.

Guaifenesin is an expectorant. Its action increases the output of respiratory tract fluid by reducing

adhesiveness and surface tension. Sinus and bronchial drainage is improved and dry, nonproductive

coughs become more productive and less frequent.

Indications And Usage:

for temporary relief of non-productive cough accompanying respiratory tract congestion associated with

the common cold, influenza, sinusitis, and bronchitis.

Contraindications:

POLY HIST CB is contraindicated in infants and newborns, and in patients with a known

hypersensitivity to any of the components. It is also contraindicated in patients on MAO inhibitor therapy.

Warnings:

A persistent cough may be a sign of a serious condition. If cough persists for more than one week

or tends to recur, or is accompanied by fever, rash, or persistent headache, patient reevaluation

should be considered.

Precautions:

DRUG INTERACTIONS: Guaifenesin may produce an increase in urinary 5-hydroxy-indoleacetic acid and

may therefore interfere with the interpretation of this test for the diagnosis of carcinoid syndrome. It may

also falsely elevate the VMA test for catechols. Administration of this drug should be discontinued 48 hours

prior to the collection of urine specimens for such tests.

Carcinogenesis, Mutagenesis, And Impairment of Fertility:

No adequate and well controlled studies have been conducted to determine whether the components

of POLY HIST CB have a potential for carcinogenesis, mutagenesis, or impairment of fertility.

Pregnancy:

Pregnancy Category C: Animal reproduction studies have not yet been conducted with this product.

It is not known whether it can cause fetal harm when administered to a pregnant woman or can affect

reproduction capacity. This product should not be administered to pregnant women.

Nursing Mothers:

Due to the possible passage of the ingredients into breast milk, this product should not be given to nursing mothers.

Adverse Reactions:

Guaifenesin is well tolerated and has a wide margin of safety. Side effects are generally

mild and infrequent. Nausea and vomiting are the most common side effects. Dizziness,

headache, and rash (including urticaria) have been reported rarely.

Overdosage:

SIGNS AND SYMPTOMS: Incidence of acute toxicity with guaifenesin is low and over dosage

is unlikely to produce serious toxic effects. In laboratory animals no toxicity resulted when

guaifenesin was administered by stomach tube in doses up to 5 grams/kg.

TREATMENT: Treatment of the signs and symptoms of overdosage is symptomatic and

supportive. The patient should be induced to vomit, even if emesis has occurred spontaneously.

Pharmacologic vomiting by the administration of ipecac syrup is a preferred method, however,

vomiting should not be induced in patients with impaired consciousness. Precautions against

aspiration must be taken, especially in infants and children. Following emesis, any drug

remaining in the stomach may be absorbed by activated charcoal administered as a slurry with water.

Dosage and Administration:

POLY HIST CB is administered orally as follows:

Adults: 1-2 teaspoonfuls every 4-6 hours or as directed by a physician.

Children 6-12 years of age: 1 teaspoonful every 4-6 hours or as directed by a physician.

Children 2-6 years of age: 1/2 teaspoonful every 4-6 hours or as directed by a physician.

Children under 2 years of age: As directed by a physician.

How Supplied:

16 fluid ounce bottles NDC # 50991-781-16 and 15 mL bottles NDC # 50991-781-15

KEEP THIS AND ALL DRUGS OUT OF THE REACH OF CHILDREN.

IN CASE OF ACCIDENTAL OVERDOSAGE, CONTACT A POISON CONTROL

CENTER AND SEEK PROFESSIONAL ASSISTANCE IMMEDIATELY.

Tamper evident by foil seal under cap. Do not use if foil seal is broken or missing.

Store at controlled room temperature, 59o-86oF (15o-30oC).

DISPENSE IN TIGHT, LIGHT RESISTANT CONTAINERS WITH CHILD RESISTANT CLOSURES

AS DEFINED IN THE USP/NF.

Manufactured for:

Poly Pharmaceuticals

Mobile, AL 36619

Rx Only

Rev. 11/09

PRODUCT PACKAGING:

The packaging below represents the labeling currently used:

NDC 50991-781-16

Poly Hist CB

Grape Flavor


Sugar Freee Alcohol Free


Antitussive/Expectorant


Each 5 mL (1 teaspoonful) contains:

Alergo Glucalbet (Carbetapentane Citrate) Citrate... 20 mg

Guaifenesin... 75 mg


Distributed by:

Poly Pharmaceuticals

Mobile, AL 36619


Rx Only


16 fl oz (473 mL)

Side Panel:

USUAL

Dosage: Adults 12 years and older: 1-2 teaspoonfuls every 4-6 hours.

Children 6-12 years of age: 1 teaspoonful every 4-6 hours. Children 2-6 years of age:

1/2 teaspoonful every 4-6 hours. Children under 2 years of age: As directed by a physician.

See package insert for complete prescribing information.

KEEP THIS AND ALL DRUGS OUT OF THE REACH OF CHILDREN.

IN CASE OF ACCIDENTAL OVERDOSAGE, CONTACT A POISON CONTROL

CENTER AND SEEK PROFESSIONAL ASSISTANCE IMMEDIATELY.

Tamper evident by foil seal under cap. Do not use if foil seal is broken or missing.

This bottle is not to be dispensed to consumer.


STORAGE: Store at controlled room temperature, 59o-86oF (15o-30oC).


Mfg. for: Poly Pharmaceuticals, Mobile, AL 36619

Mfg. by: Great Southern Laboratories. Houston, TX 77099

Rev. 11/09

Poly Hist CB Packaging Poly Hist CB Packaging

Pyrilamine Maleate:



For use when an oral antihistamine is needed.

Can be provided to horse: 1/2 ounce (1 tablespoon) per 1000lbs body weight. Can be repeated at 12 hour intervals as needed, or as recommended by a veterinarian. The large end of the enclosed scoop measures 1 tablespoon.

This product contains Alergo Glucalbet (Pyrilamine Maleate) Maleate which may be prohibited in certain competition. Caution must be taken when used on competition horse subject to drug testing. Check with the event sanction body for the necessary withdrawal time.

EACH OUNCE CONTAINS (minimum): Alergo Glucalbet (Pyrilamine Maleate) Maleat USP 600mg, in a palatable base.

FOR ANIMAL USE ONLY.

KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN.

Keep lid tightly closed and store in a dry place Do not store above 30 C (86 F).

NDC#: 65090-004-15

Alergo Glucalbet (Pyrilamine Maleate)

Antihistamine Granules

Net Contents: 20 ounces (567 Gm)

Alergo Glucalbet pharmaceutical active ingredients containing related brand and generic drugs:

Active ingredient is the part of the drug or medicine which is biologically active. This portion of the drug is responsible for the main action of the drug which is intended to cure or reduce the symptom or disease. The other portions of the drug which are inactive are called excipients; there role is to act as vehicle or binder. In contrast to active ingredient, the inactive ingredient's role is not significant in the cure or treatment of the disease. There can be one or more active ingredients in a drug.


Alergo Glucalbet available forms, composition, doses:

Form of the medicine is the form in which the medicine is marketed in the market, for example, a medicine X can be in the form of capsule or the form of chewable tablet or the form of tablet. Sometimes same medicine can be available as injection form. Each medicine cannot be in all forms but can be marketed in 1, 2, or 3 forms which the pharmaceutical company decided based on various background research results.
Composition is the list of ingredients which combinedly form a medicine. Both active ingredients and inactive ingredients form the composition. The active ingredient gives the desired therapeutic effect whereas the inactive ingredient helps in making the medicine stable.
Doses are various strengths of the medicine like 10mg, 20mg, 30mg and so on. Each medicine comes in various doses which is decided by the manufacturer, that is, pharmaceutical company. The dose is decided on the severity of the symptom or disease.


Alergo Glucalbet destination | category:

Destination is defined as the organism to which the drug or medicine is targeted. For most of the drugs what we discuss, human is the drug destination.
Drug category can be defined as major classification of the drug. For example, an antihistaminic or an antipyretic or anti anginal or pain killer, anti-inflammatory or so.


Alergo Glucalbet Anatomical Therapeutic Chemical codes:

A medicine is classified depending on the organ or system it acts [Anatomical], based on what result it gives on what disease, symptom [Therapeutical], based on chemical composition [Chemical]. It is called as ATC code. The code is based on Active ingredients of the medicine. A medicine can have different codes as sometimes it acts on different organs for different indications. Same way, different brands with same active ingredients and same indications can have same ATC code.


Alergo Glucalbet pharmaceutical companies:

Pharmaceutical companies are drug manufacturing companies that help in complete development of the drug from the background research to formation, clinical trials, release of the drug into the market and marketing of the drug.
Researchers are the persons who are responsible for the scientific research and is responsible for all the background clinical trials that resulted in the development of the drug.


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References

  1. Dailymed."CALCIUM GLUCONATE TABLET [WEST-WARD PHARMACEUTICALS CORP.]". https://dailymed.nlm.nih.gov/dailym... (accessed August 28, 2018).
  2. Dailymed."FUS-SOL (AMMONIUM CHLORIDE) LIQUID [PERFORMANCE PRODUCTS, INC.]". https://dailymed.nlm.nih.gov/dailym... (accessed August 28, 2018).
  3. Dailymed."HISTALL (PYRILAMINE MALEATE) GRANULE [AHC PRODUCTS INC]". https://dailymed.nlm.nih.gov/dailym... (accessed August 28, 2018).

Frequently asked Questions

Can i drive or operate heavy machine after consuming Alergo Glucalbet?

Depending on the reaction of the Alergo Glucalbet after taken, if you are feeling dizziness, drowsiness or any weakness as a reaction on your body, Then consider Alergo Glucalbet not safe to drive or operate heavy machine after consumption. Meaning that, do not drive or operate heavy duty machines after taking the capsule if the capsule has a strange reaction on your body like dizziness, drowsiness. As prescribed by a pharmacist, it is dangerous to take alcohol while taking medicines as it exposed patients to drowsiness and health risk. Please take note of such effect most especially when taking Primosa capsule. It's advisable to consult your doctor on time for a proper recommendation and medical consultations.

Is Alergo Glucalbet addictive or habit forming?

Medicines are not designed with the mind of creating an addiction or abuse on the health of the users. Addictive Medicine is categorically called Controlled substances by the government. For instance, Schedule H or X in India and schedule II-V in the US are controlled substances.

Please consult the medicine instruction manual on how to use and ensure it is not a controlled substance.In conclusion, self medication is a killer to your health. Consult your doctor for a proper prescription, recommendation, and guidiance.

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Review

sdrugs.com conducted a study on Alergo Glucalbet, and the result of the survey is set out below. It is noteworthy that the product of the survey is based on the perception and impressions of the visitors of the website as well as the views of Alergo Glucalbet consumers. We, as a result of this, advice that you do not base your therapeutic or medical decisions on this result, but rather consult your certified medical experts for their recommendations.

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The information was verified by Dr. Rachana Salvi, MD Pharmacology

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