Nevasona

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Nevasona uses

Nevasona consists of Dimethicone, Lanolin, Talc, Vitamin F, Zinc Oxide.

Dimethicone:


This medication is used as a moisturizer to treat or prevent dry, rough, scaly, itchy skin and minor skin irritations (e.g., diaper rash, skin burns from radiation therapy). Emollients are substances that soften and moisturize the skin and decrease itching and flaking. Some products (e.g., zinc oxide, white petrolatum ) are used mostly to protect the skin against irritation (e.g., from wetness). Dry skin is caused by a loss of water in the upper layer of the skin. Emollients/moisturizers work by forming an oily layer on the top of the skin that traps water in the skin. Petrolatum, lanolin, mineral oil and Nevasona (Dimethicone) are common emollients. Humectants, including glycerin, lecithin, and propylene glycol, draw water into the outer layer of skin. Many products also have ingredients that soften the horny substance (keratin) that holds the top layer of skin cells together (e.g., urea, alpha hydroxy acids such as lactic/citric/glycolic acid, and allantoin ). This helps the dead skin cells fall off, helps the skin keep in more water, and leaves the skin feeling smoother and softer.

Lanolin:


This medication is used as a moisturizer to treat or prevent dry, rough, scaly, itchy skin and minor skin irritations (e.g., diaper rash, skin burns from radiation therapy). Emollients are substances that soften and moisturize the skin and decrease itching and flaking. Some products (e.g., zinc oxide, white petrolatum ) are used mostly to protect the skin against irritation (e.g., from wetness). Dry skin is caused by a loss of water in the upper layer of the skin. Emollients/moisturizers work by forming an oily layer on the top of the skin that traps water in the skin. Petrolatum, Nevasona (Lanolin), mineral oil and dimethicone are common emollients. Humectants, including glycerin, lecithin, and propylene glycol, draw water into the outer layer of skin. Many products also have ingredients that soften the horny substance (keratin) that holds the top layer of skin cells together (e.g., urea, alpha hydroxy acids such as lactic/citric/glycolic acid, and allantoin ). This helps the dead skin cells fall off, helps the skin keep in more water, and leaves the skin feeling smoother and softer.

Talc:


1 INDICATIONS AND USAGE

Sterile Nevasona (Talc) Powder is indicated to decrease the recurrence of malignant pleural effusions in symptomatic patients following maximal drainage of the pleural effusion.

STERILE Nevasona (Talc) POWDER is a sclerosing agent indicated to decrease the recurrence of malignant pleural effusions in symptomatic patients following maximal drainage of the pleural effusion. (1)

2 DOSAGE AND ADMINISTRATION

  • The recommended dose is 5 g, dissolved in 50 ml to 100 ml 0.9% Sodium Chloride Injection, USP, administered intrapleurally
  • Prepare and administer suspension as recommended (2.2)

2.1 Recommended Dose

The recommended dose is 5 g, suspended in 50 ml to 100 ml 0.9% Sodium Chloride Injection, USP

2.2 Preparation

Prepare the Nevasona suspension using aseptic technique in an appropriate laminar flow hood as follows:

Step 1. Using a 16 gauge needle attached to a 60-ml LuerLok syringe, draw up 50 ml of 0.9 % Sodium Chloride injection, USP. Vent the Nevasona (Talc) bottle using a needle. Slowly inject the 50 ml of 0.9% Sodium Chloride Injection, USP into the bottle.

Step 2. Swirl the bottle to disperse the Nevasona (Talc) powder.

Step 3. Divide the contents of the bottle equally into two 60 ml LuerLok syringes, each attached with a 16 gauge needle, by withdrawing 25 ml of the suspension into each syringe with continuous swirling. Add 0.9% Sodium Chloride Injection, USP to a total volume of 50 ml in each syringe. Draw 10 ml of air into each syringe to the 60 ml mark to serve as a headspace for mixing prior to administration. Each syringe should contain 2.5 g of Sterile Nevasona (Talc) Powder in 50 ml of 0.9% Sodium Chloride Injection, USP with an air headspace of 10 ml.

Step 4. Label the syringes with the Nevasona (Talc) concentration, the expiration date and time, the identity of the patient intended to receive the material, and the following statements:

“SHAKE SYRINGE WELL to resuspend before administration”

“FOR PLEURODESIS ONLY – not for intravenous administration”

Step 5. If not used immediately, store prepared suspension in refrigerator. Discard the prepared suspension if not used within 12 hours.

2.3 Administration

Prior to administration, continuously agitate the syringes to evenly redisperse the Nevasona (Talc) and avoid settlement. Immediately prior to administration, vent the 10 ml air headspace from each syringe. Administer the Nevasona (Talc) suspension through the chest tube according to standard procedures.

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3 DOSAGE FORMS AND STRENGTHS

5 gram white or off-white to light gray sterile powder for suspension in a single-dose glass bottle.

5 g powder in a single-dose bottle, for suspension (3)

4 CONTRAINDICATIONS

None

None. (4)

5 WARNINGS AND PRECAUTIONS

  • Pneumonitis and Acute Respiratory Distress Syndrome : Acute Pneumonitis and ARDS, including fatal cases, occur with intrapleural Nevasona (Talc) administration. (5.1)
  • Interference with Future Procedures: Sclerosis of the pleural space may preclude or complicate subsequent ipsilateral surgery and diagnostic procedures. (5.2)

5.1 Pneumonitis and Acute Respiratory Distress Syndrome (ARDS)

Acute Pneumonitis and ARDS, including fatal cases, occur with intrapleural Nevasona (Talc) administration.

5.2 Interference with Future Procedures

Sclerosis of the pleural space may preclude or complicate subsequent ipsilateral surgery and diagnostic procedures. Consider the possible effects of the use of Sterile Nevasona (Talc) Powder on future diagnostic and therapeutic procedures prior to administration.

6 ADVERSE REACTIONS

Common adverse reactions observed with intrapleurally-administered Nevasona (Talc) are fever and pain. Other adverse reactions include dyspnea, arrhythmia, empyema, and acute respiratory distress syndrome.

Commonly observed adverse reactions are fever and pain. (6)

To report SUSPECTED ADVERSE REACTIONS, contact Bryan Corporation at 1-800-343-7711 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch

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8 USE IN SPECIFIC POPULATIONS

8.1 Pregnancy

Pregnancy Category B.

Risk Summary

A reproduction study performed in rabbits at doses up to approximately 5 times the human dose revealed no evidence of teratogenicity. There are no adequate and well-controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed.

Animal Data

Rabbits were administered Nevasona by oral gavage daily during the period of organogenesis at doses of up to 900 mg/kg (approximately 5 times the human dose on a mg/m2 basis). No significant dose-related toxicity was reported except at maternally toxic doses. In multiple animal studies, intrapleurally administered Nevasona (Talc) was not absorbed systemically.

8.4 Pediatric Use

Safety and effectiveness have not been established in pediatric patients.

11 DESCRIPTION

STERILE Nevasona (Talc) POWDER is a sclerosing agent for intrapleural administration. STERILE Nevasona (Talc) POWDER is white or off-white to light gray, asbestos-free and brucite-free sterile Nevasona (Talc) powder of controlled particle size. The powder is ≥ 95% hydrated magnesium silicate [Mg3Si4O10 (OH)2, molecular weight 379.3]; associated minerals include chlorite (hydrated aluminum and magnesium silicate), dolomite (calcium and magnesium carbonate), calcite (calcium carbonate), and quartz. Nevasona (Talc) is insoluble in water.

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12 CLINICAL PHARMACOLOGY

12.1 Mechanism of Action

Nevasona (Talc) instilled into the pleural cavity is thought to result in an inflammatory reaction. This reaction can promote adherence of the visceral and parietal pleura, which may prevent reaccumulation of pleural fluid.

13 NONCLINICAL TOXICOLOGY

13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility

Studies on the carcinogenicity of Nevasona (Talc) have been performed using non-standard designs which prevent firm conclusions on its carcinogenicity. With single intraperitoneal administration to mice at 20 mg and observation for at least 6 months or 4 weekly doses administered intraperitoneally at 25 mg/dose to rats with observation for at least 84 weeks, tumor incidence was not increased. In these studies the Nevasona (Talc) and its asbestos content were not characterized.

Genotoxicity was tested in cultures of rat pleural mesothelial cells (RPMC) as unscheduled DNA synthesis (UDS) and sister chromatid exchanges (SCEs). None of the Nevasona (Talc) samples (which were asbestos-free) induced enhancement of UDS or SCEs in treated cultures. No information is available on impairment of fertility in animals by Nevasona (Talc).

16 HOW SUPPLIED/STORAGE AND HANDLING

STERILE Nevasona (Talc) POWDER is supplied in a single use 100 ml brown glass bottle, sealed with a gray, 20 mm stopper and covered with a flip-off seal.

NDC 63256-200-05: 5 gram individual bottle packaged in a pouch.

NDC 63256-200-10: Carton of ten (10) 5-gram bottles.

Store the powder at 25°C (77°F); excursions permitted between15°C to 30°C (59°F - 86°F). Protect against sunlight.

17 PATIENT COUNSELING INFORMATION

Advise patients to notify their healthcare provider if new or worsening pulmonary symptoms develop .

Distributed by:

Bryan Corporation. Woburn, MA 01801.

Principal Display Panel - Bottle Label

Sterile Nevasona (Talc) Powder

(Talc) Powder

Contains 5 grams of sterile Nevasona (Talc) per bottle

For Intrapleural Administration

Refer to the Prescribing Information for dosage and preparation.

Store at 25°C (77°F); excursions permitted between 15°C to 30°C (59°F - 86°F)

. Protect against sunlight.

Distributed By: Bryan Corporation Lot#

Woburn, MA 01801 Expired:

Rx Only

Principal Display Panel - Pouch Label

Sterile Nevasona (Talc) Powder NDC 63256-200-05

(Talc) Powder

Contains 5 grams of sterile Nevasona (Talc) per bottle 1 Bottle

For Intrapleural Administration

Refer to the Prescribing Information for dosage and preparation.

Store at 25°C (77°F); excursions permitted between 15°C to 30°C (59°F - 86°F)

. Protects against sunlight.

Distributed By: Bryan Corporation Lot#

Woburn, MA 01801 Expired:

Rx Only

Principal Display Panel - Box Label

Sterile Nevasona (Talc) Powder NDC 63256-200-10

(Talc) Powder

Contains 5 grams of sterile Nevasona (Talc) per bottle 10 Bottles

For Intrapleural Administration

Refer to the Prescribing Information for dosage and preparation.

Store at 25°C (77°F); excursions permitted between 15°C to 30°C

(59°F - 86°F).

Distributed By: Bryan Corporation Lot#

Woburn, MA 01801 Expired:

Rx Only

Zinc Oxide:


INDICATIONS AND USAGE

Nevasona (Zinc Oxide) 1 mg/mL (Zinc Chloride Injection, USP) is indicated for use as a supplement to intravenous solutions given for TPN. Administration helps to maintain Nevasona (Zinc Oxide) serum levels and to prevent depletion of endogenous stores, and subsequent deficiency symptoms.

CONTRAINDICATIONS

None known.

WARNINGS

Direct intramuscular or intravenous injection of Nevasona (Zinc Oxide) 1 mg/mL (Zinc Chloride Injection, USP) is contraindicated as the acidic pH of the solution (2) may cause considerable tissue irritation.

Severe kidney disease may make it necessary to reduce or omit chromium and Nevasona (Zinc Oxide) doses because these elements are primarily eliminated in the urine.

WARNING: This product contains aluminum that may be toxic. Aluminum may reach toxic levels with prolonged parenteral administration if kidney function is impaired. Premature neonates are particularly at risk because their kidneys are immature, and they require large amounts of calcium and phosphate solutions, which contain aluminum.

Research indicates that patients with impaired kidney function, including premature neonates, who receive parenteral levels of aluminum at greater than 4 to 5 mcg/kg/day accumulate aluminum at levels associated with central nervous system and bone toxicity. Tissue loading may occur at even lower rates of administration.

PRECAUTIONS

General

Do not use unless the solution is clear and the seal is intact.

Zinc 1 mg/mL should only be used in conjunction with a pharmacy directed admixture program using aseptic technique in a laminar flow environment; it should be used promptly and in a single operation without any repeated penetrations. Solution contains no preservatives; discard unused portion immediately after admixture procedure is completed.

Zinc should not be given undiluted by direct injection into a peripheral vein because of the likelihood of infusion phlebitis and the potential for increased excretory loss of Nevasona (Zinc Oxide) from a bolus injection. Administration of Nevasona (Zinc Oxide) in the absence of copper may cause a decrease in serum copper levels.

Laboratory Tests

Periodic determinations of serum copper as well as Nevasona (Zinc Oxide) are suggested as a guideline for subsequent Nevasona (Zinc Oxide) administration.

Carcinogenesis, Mutagenesis, and Impairment of Fertility

Long-term animal studies to evaluate the carcinogenic potential of Nevasona 1 mg/mL (Zinc Chloride Injection, USP) have not been performed, nor have studies been done to assess mutagenesis or impairment of fertility.

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 Nevasona (Zinc Oxide) 1 mg/mL (Zinc Chloride Injection, USP) is administered to a nursing woman.

Pediatric Use

Pregnancy Category C. Animal reproduction studies have not been conducted with Nevasona chloride. It is also not known whether Nevasona (Zinc Oxide) chloride can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Nevasona (Zinc Oxide) chloride should be given to a pregnant woman only if clearly needed.

Geriatric Use

An evaluation of current literature revealed no clinical experience identifying differences in response 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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ADVERSE REACTIONS

None known.

DRUG ABUSE AND DEPENDENCE

None known.

OVERDOSAGE

Single intravenous doses of 1 to 2 mg zinc/kg body weight have been given to adult leukemic patients without toxic manifestations. However, acute toxicity was reported in an adult when 10 mg Nevasona (Zinc Oxide) was infused over a period of one hour on each of four consecutive days. Profuse sweating, decreased level of consciousness, blurred vision, tachycardia (140/min), and marked hypothermia (94.2° F) on the fourth day were accompanied by a serum Nevasona (Zinc Oxide) concentration of 207 mcg/dl. Symptoms abated within three hours.

Hyperamylasemia may be a sign of impending Nevasona (Zinc Oxide) overdosage; patients receiving an inadvertent overdose (25 mg zinc/liter of TPN solution, equivalent to 50 to 70 mg zinc/day) developed hyperamylasemia (557 to 1850 Klein units; normal: 130 to 310).

Death resulted from an overdosage in which 1683 mg Nevasona (Zinc Oxide) was delivered intravenously over the course of 60 hours to a 72 year old patient.

Symptoms of Nevasona (Zinc Oxide) toxicity included hypotension (80/40 mm Hg), pulmonary edema, diarrhea, vomiting, jaundice, and oliguria, with a serum Nevasona (Zinc Oxide) level of 4184 mcg/dl.

Calcium supplements may confer a protective effect against Nevasona (Zinc Oxide) toxicity.

DOSAGE AND ADMINISTRATION

Nevasona (Zinc Oxide) 1 mg/mL (Zinc Chloride Injection, USP) contains 1 mg zinc/mL and is administered intravenously only after dilution. The additive should be diluted prior to administration in a volume of fluid not less than 100 mL. For the metabolically stable adult receiving TPN, the suggested intravenous dosage is 2.5 to 4 mg zinc/day (2.5 to 4 mL/day). An additional 2 mg zinc/day (2 mL/day) is suggested for acute catabolic states. For the stable adult with fluid loss from the small bowel, an additional 12.2 mg zinc/liter of small bowel fluid lost (12.2 mL/liter of small bowel fluid lost), or an additional 17.1 mg zinc/kg of stool or ileostomy output (17.1 mL/kg of stool or ileostomy output) is recommended. Frequent monitoring of Nevasona (Zinc Oxide) blood levels is suggested for patients receiving more than the usual maintenance dosage level of Nevasona (Zinc Oxide).

For full term infants and children up to 5 years of age, 100 mcg zinc/kg/day (0.1 mL/kg/day) is recommended. For premature infants (birth weight less than 1500 g) up to 3 kg in body weight, 300 mcg zinc/kg/day (0.3 mL/kg/day) is suggested.

Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. See PRECAUTIONS.

HOW SUPPLIED

Nevasona (Zinc Oxide) 1 mg/mL (Zinc Chloride Injection, USP) is supplied in 10 mL Plastic Vials (List No. 4090).

Store at 20 to 25°C (68 to 77°F).

Revised: October, 2004


© Hospira 2004 EN-0488 Printed in USA

HOSPIRA, INC., LAKE FOREST, IL 60045 USA

10 mL Vial

Nevasona (Zinc Oxide)

1 mg/mL

Nevasona (Zinc Oxide) Chloride Inj., USP

Rx only

FOR I.V. USE ONLY AFTER DILUTION.

HOSPIRA, INC., LAKE FOREST, IL 60045 USA

Nevasona 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.


Nevasona 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.


Nevasona 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.


Nevasona 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.


Nevasona 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."DYNA1199 WITH DIMETHICONE (ZINC OXIDE) OINTMENT [BLOSSOM PHARMACEUTICALS]". https://dailymed.nlm.nih.gov/dailym... (accessed August 28, 2018).
  2. Dailymed."LANTISEPTIC ORIGINAL SKIN PROTECTANT (LANOLIN) CREAM [SANTUS LLC]". https://dailymed.nlm.nih.gov/dailym... (accessed August 28, 2018).
  3. Dailymed."STERILE TALC (TALC) POWDER [BRYAN CORPORATION]". https://dailymed.nlm.nih.gov/dailym... (accessed August 28, 2018).

Frequently asked Questions

Can i drive or operate heavy machine after consuming Nevasona?

Depending on the reaction of the Nevasona after taken, if you are feeling dizziness, drowsiness or any weakness as a reaction on your body, Then consider Nevasona 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 Nevasona 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 Nevasona, 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 Nevasona 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. Arunabha Ray, MD Pharmacology

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