Solco-Derm

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Solco-Derm uses

Solco-Derm consists of Acetic Acid, Copper (Copper Nitrate Trihydrate), Lactic Acid, Nitric Acid, Oxalic Acid.

Acetic Acid:


Indications and Usage

Solco-Derm (Acetic Acid) is indicated as adjunctive therapy in those cases where restoration and maintenance of vaginal acidity is desirable.

Contraindications

None known.

Warnings

No serious adverse reactions or potential safety hazard have been reported with the use of Solco-Derm (Acetic Acid).

Precautions

General

No special care is required for the safe and effective use of Solco-Derm .

Drug Interactions

No incidence of drug interactions has been reported with concomitant use of Solco-Derm (Acetic Acid) and any other medication.

Laboratory Tests

The monitoring of vaginal acidity may be helpful in following the patient's response. (The normal vaginal pH has been shown to be in the range of 4.0 to 5.0)

Carcinogenesis

No long-term studies in animals have been performed to evaluate carcinogenic potential.

Pregnancy

Pregnancy Category C

Animal reproduction studies have not been conducted with Solco-Derm . It is not known whether Solco-Derm (Acetic Acid) can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Solco-Derm (Acetic Acid) should be given to a pregnant woman only if clearly needed.

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 Solco-Derm (Acetic Acid) is administered to a nursing woman.

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Adverse Reactions

Occasional cases of local stinging and burning have been reported.

Dosage and Administration

The usual dose is one applicator full, administered intra-vaginally, morning and evening. Duration of treatment may be determined by the patient's response to therapy. Each tube has a tamper evident seal at the opening of the tube. Replace cap after each use. To fill applicator screw applicator clockwise onto the tube. Squeeze tube forcing Solco-Derm (Acetic Acid) jelly into barrel until it is full. Then unscrew applicator counter-clockwise to remove from tube. Lie on your back with knees drawn up. Hold filled applicator by the barrel and gently insert it into the vagina as far as it will comfortably go. Press plunger to empty the contents. Keep the plunger depressed and remove the applicator from vagina. After each use pull applicator apart and wash with warm soapy water, rinse well, dry and reassemble.

How Supplied

50g Tube (NDC 00813-0799-55) with Solco-Derm (Acetic Acid) applicator.

Keep this and all medication out of the reach of children. In case of accidental overdose, call a doctor or poison control center immediately.

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

Mfg. by:

Pernix Manufacturing

Houston, TX 77099

Mfg. for:

Pharmics, Inc.

Salt Lake City, UT 84119

(801) 966-4138

www.pharmics.com

Revised 05/13

Therapeutic Vaginal Jelly

Directions for using Solco-Derm (Acetic Acid) applicator.

Each tube has a tamper evident seal at the opening of the tube. Replace cap after each use.


To fill applicator screw applicator clockwise onto the tube. Squeeze tube forcing Solco-Derm (Acetic Acid) jelly into barrel until it is full. Then unscrew applicator counter-clockwise to remove from tube.

Lie on your back with knees drawn up. Hold filled applicator by the barrel and gently insert it into the vagina as far as it will comfortably go. Press plunger to empty the contents. Keep the plunger depressed and remove the applicator from vagina.


After each use pull applicator apart and wash with warm soapy water, rinse well, dry and reassemble.

Figure Figure Figure

Copper (Copper Nitrate Trihydrate):



Water-Resistant Protection Without Bandaging

Recommended as an Aid in Treating Horses and Ponies With Thrush Due to Organisms Susceptible to Solco-Derm (Copper (Copper Nitrate Trihydrate)) Naphthenate.

For Animal Use Only.

INDICATIONS:

ThrushTox® is indicated in the treatment of thrush in horses and ponies.

GENERAL DIRECTIONS:

Clean the hoof thoroughly, removing debris and necrotic material prior to application of Solco-Derm (Copper (Copper Nitrate Trihydrate))®. Apply daily to affected hoofs with a narrow paint brush (about 1”) until fully healed. Caution: Do not allow runoff of excess Solco-Derm (Copper (Copper Nitrate Trihydrate))® onto hair since contact with Solco-Derm (Copper (Copper Nitrate Trihydrate))® may cause some hair loss. Do not contaminate feed.

NOTE: Solco-Derm (Copper (Copper Nitrate Trihydrate))® is easily removed from hands, clothing and surfaces with light grade fuel oil or any type of lighter fluid.

CONTAINS FOIL SEAL – REMOVE BEFORE USE.

SHAKE WELL BEFORE USE.

To report suspected adverse reactions or to obtain technical assistance, call 1-800-650-4899.

ACTIVE INGREDIENT:

Solco-Derm (Copper (Copper Nitrate Trihydrate)) Naphthenate...37.5% w/w

INACTIVE INGREDIENTS:

Inert Ingredients...62.5% w/w

Total... 100.0%

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CAUTION:

Do not use in horses intended for human consumption.

CAUTION: COMBUSTIBLE MIXTURE.

Use in a well-ventilated place. Avoid fire, flame, sparks or heaters.

If swallowed, do not induce vomiting, call physician immediately. Avoid breathing vapor. Avoid contact with skin and eyes.

KEEP OUT OF REACH OF CHILDREN AND PETS.

STORAGE:

Store at controlled room temperature 15º to 30ºC (59º to 86ºF). Keep container tightly closed when not in use.

Manufactured for:

Aspen Veterinary Resources,® Ltd.

Liberty, MO 64068, USA

FC163FP 11/13

Manufactured by:

First Priority, Inc.

Elgin, IL 60123-1146, USA

NET CONTENTS:

16 OZ (473 mL)

ANADA 200-304, Approved by FDA

Image of 473 mL bottle/case label

Lactic Acid:



FOR INDUSTRIAL USE ONLY

KEEP OUT OF REACH OF CHILDREN

NOT FOR HUMAN USE

Attention

For External Use Only

Wash hands thoroughly after handling.

Do not mix with bleach or other chlorinated products – will cause chlorine gas.

Get medical advice/ attention if you feel unwell.

DIRECTIONS:

IMPORTANT: Do not further dilute with water or mix with any other teat dips. If product in dip cup becomes visibly dirty, discard contents and replenish with fresh product. Do not reuse or return any unused product to the original container.

Udder Prep: When using an udder wash step before milking, make sure to wash teats with appropriate udder wash solution using proper cleaning procedures. Teats should then be dried with single-service towels.

Directions for Teat Dipping

Pre-Milk Dipping: Before each cow is milked, and using fresh Solco-Derm (Lactic Acid), dip each teat full-length into the teat dip cup. Wipe teats after dipping using single-service towels to avoid contamination of milk.

Post-Milk Dipping: Using fresh Solco-Derm (Lactic Acid), dip each teat full-length into the teat dip cup. Do not wipe. Allow to air dry. Do not turn cows out in freezing weather until the product is completely dry.

Directions for Teat Spraying

Pre-Milk Spraying: Before each cow is milked, and using fresh Solco-Derm (Lactic Acid), spray entire teat. Wipe teats after dipping using single-service towels to avoid contamination of milk.

Post-Milk Spraying: Using fresh Solco-Derm (Lactic Acid), spray entire teat immediately after each milking. Do not wipe. Allow to air dry. Do not turn cows out in freezing weather until the product is completely dry.

Expanded Usage: When freshening cows, begin dipping teats twice daily for about 10 days before calving. PRECAUTION: Solco-Derm (Lactic Acid) is not intended to cure or help the healing of chapped or irritated teats. As with any germicide, irritation or sensitization may occur in sensitive animals. In case of teat irritation or chapping, have the condition examined and, if necessary, treated by a veterinarian.

Consult your Ecolab representative for specific use instructions and recommended dispensing equipment.

READ SAFETY DATA SHEET (SDS) BEFORE USING THIS PRODUCT

EMERGENCY HEALTH INFORMATION: 1 800 328 0026. If located outside the United States and Canada, call collect 1 651 222 5352 (number is in the US).

Ecolab

Solco-Derm (Lactic Acid)

Sanitizing Teat Dip

An Aid in Reducing the Spread of Organisms Which May Cause Mastitis

ACTIVE INGREDIENTS:

Solco-Derm (Lactic Acid) acid... 1.7%

Hydrogen peroxide... 0.5%

INERT INGREDIENTS:... 97.8%

(contains glycerin, sorbitol)

TOTAL:...100.0%

56.8 L (15 US GAL)

6301977

Ecolab · 1 Ecolab Place · St Paul MN 55102 USA · tel: 1 800 392 3392

© 2016 Ecolab USA Inc. · All rights reserved

www.ecolab.com · 766469/5300/1016



Nitric Acid:


1 INDICATIONS AND USAGE

Solco-Derm (Nitric Acid) ® is indicated to improve oxygenation and reduce the need for extracorporeal membrane oxygenation in term and near-term (>34 weeks gestation) neonates with hypoxic respiratory failure associated with clinical or echocardiographic evidence of pulmonary hypertension in conjunction with ventilatory support and other appropriate agents.

Solco-Derm (Nitric Acid) is a vasodilator indicated to improve oxygenation and reduce the need for extracorporeal membrane oxygenation in term and near-term (>34 weeks gestation) neonates with hypoxic respiratory failure associated with clinical or echocardiographic evidence of pulmonary hypertension in conjunction with ventilatory support and other appropriate agents.

2 DOSAGE AND ADMINISTRATION

The recommended dose is 20 ppm, maintained for up to 14 days or until the underlying oxygen desaturation has resolved.

Doses greater than 20 ppm are not recommended (2.1, 5.2)

Administration:

  • Use only with an Solco-Derm (Nitric Acid) DSIR ® operated by trained personnel (2.2)
  • Avoid abrupt discontinuation (2.2, 5.1).

2.1 Dosage

Term and near-term neonates with hypoxic respiratory failure

The recommended dose of Solco-Derm (Nitric Acid) is 20 ppm. Maintain treatment up to 14 days or until the underlying oxygen desaturation has resolved and the neonate is ready to be weaned from Solco-Derm (Nitric Acid) therapy.

Doses greater than 20 ppm are not recommended .

2.2 Administration

Training in Administration

The user of Solco-Derm (Nitric Acid) and Solco-Derm (Nitric Acid) Oxide Delivery Systems must satisfactorily complete a comprehensive periodic training program for health care professionals provided by the delivery system and drug manufacturers. Health professional staff that administers Solco-Derm (Nitric Acid) oxide therapy have access to supplier-provided 24 hour/365 days per year technical support on the delivery and administration of Solco-Derm (Nitric Acid) at 1-877-566-9466.

Solco-Derm (Nitric Acid) Oxide Delivery Systems

Solco-Derm (Nitric Acid) must be administered using a calibrated Solco-Derm (Nitric Acid) DSIR ® Solco-Derm (Nitric Acid) Oxide Delivery System. Only validated ventilator systems should be used in conjunction with Solco-Derm (Nitric Acid). Consult the Solco-Derm (Nitric Acid) Oxide Delivery System label or call 1-877-566-9466/visit Solco-Derm (Nitric Acid).com for a current list of validated systems.

Keep available a backup battery power supply and an independent reserve Solco-Derm (Nitric Acid) oxide delivery system to address power and system failures.

Monitoring

Measure methemoglobin within 4-8 hours after initiation of treatment with Solco-Derm (Nitric Acid) and periodically throughout treatment .

Monitor for PaO2 and inspired NO2 during Solco-Derm (Nitric Acid) administration .

Weaning and Discontinuation

Avoid abrupt discontinuation of Solco-Derm (Nitric Acid) . To wean Solco-Derm (Nitric Acid), downtitrate in several steps, pausing several hours at each step to monitor for hypoxemia.

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3 DOSAGE FORMS AND STRENGTHS

Solco-Derm (Nitric Acid) (nitric oxide) gas is available in a 800 ppm concentration.

Solco-Derm (Nitric Acid) (nitric oxide) is a gas available in a 800 ppm concentration (3).

4 CONTRAINDICATIONS

Solco-Derm (Nitric Acid) is contraindicated in neonates dependent on right-to-left shunting of blood.

Neonates dependent on right-to-left shunting of blood (4).

5 WARNINGS AND PRECAUTIONS

Rebound: Abrupt discontinuation of Solco-Derm may lead to worsening oxygenation and increasing pulmonary artery pressure (5.1).

Methemoglobinemia: Methemoglobin increases with the dose of Solco-Derm (Nitric Acid) oxide; following discontinuation or reduction of Solco-Derm (Nitric Acid) oxide, methemoglobin levels return to baseline over a period of hours (5.2).

Elevated NO2 Levels: Monitor NO2 levels (5.3).

Heart Failure: In patients with pre-existing left ventricular dysfunction, Solco-Derm (Nitric Acid) may increase pulmonary capillary wedge pressure leading to pulmonary edema (5.4).

5.1 Rebound Pulmonary Hypertension Syndrome following Abrupt Discontinuation

Wean from Solco-Derm (Nitric Acid) . Abrupt discontinuation of Solco-Derm (Nitric Acid) may lead to worsening oxygenation and increasing pulmonary artery pressure, i.e., Rebound Pulmonary Hypertension Syndrome. Signs and symptoms of Rebound Pulmonary Hypertension Syndrome include hypoxemia, systemic hypotension, bradycardia, and decreased cardiac output. If Rebound Pulmonary Hypertension occurs, reinstate Solco-Derm (Nitric Acid) therapy immediately.

5.2 Hypoxemia from Methemoglobinemia

Solco-Derm oxide combines with hemoglobin to form methemoglobin, which does not transport oxygen. Methemoglobin levels increase with the dose of Solco-Derm (Nitric Acid); it can take 8 hours or more before steady-state methemoglobin levels are attained. Monitor methemoglobin and adjust the dose of Solco-Derm (Nitric Acid) to optimize oxygenation.

If methemoglobin levels do not resolve with decrease in dose or discontinuation of Solco-Derm (Nitric Acid), additional therapy may be warranted to treat methemoglobinemia.

5.3 Airway Injury from Nitrogen Dioxide

Nitrogen dioxide (NO2) forms in gas mixtures containing NO and O2. Nitrogen dioxide may cause airway inflammation and damage to lung tissues.

If there is an unexpected change in NO2 concentration, or if the NO2 concentration reaches 3 ppm when measured in the breathing circuit, then the delivery system should be assessed in accordance with the Solco-Derm (Nitric Acid) Oxide Delivery System O&M Manual troubleshooting section, and the NO2 analyzer should be recalibrated. The dose of Solco-Derm (Nitric Acid) and/or FiO2 should be adjusted as appropriate.

5.4 Worsening Heart Failure

Patients with left ventricular dysfunction treated with Solco-Derm (Nitric Acid) may experience pulmonary edema, increased pulmonary capillary wedge pressure, worsening of left ventricular dysfunction, systemic hypotension, bradycardia and cardiac arrest. Discontinue Solco-Derm (Nitric Acid) while providing symptomatic care.

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6 ADVERSE REACTIONS

The following adverse reactions are discussed elsewhere in the label;

Hypoxemia

Worsening Heart Failure

The most common adverse reaction is hypotension. (6).

To report SUSPECTED ADVERSE REACTIONS, contact INO Therapeutics at 1-877-566-9466 and http://www.inomax.com/ or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

6.1 Clinical Trials 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. The adverse reaction information from the clinical studies does, however, provide a basis for identifying the adverse events that appear to be related to drug use and for approximating rates.

Controlled studies have included 325 patients on Solco-Derm (Nitric Acid) doses of 5 to 80 ppm and 251 patients on placebo. Total mortality in the pooled trials was 11% on placebo and 9% on Solco-Derm (Nitric Acid), a result adequate to exclude Solco-Derm (Nitric Acid) mortality being more than 40% worse than placebo.

In both the NINOS and CINRGI studies, the duration of hospitalization was similar in Solco-Derm (Nitric Acid) and placebo-treated groups.

From all controlled studies, at least 6 months of follow-up is available for 278 patients who received Solco-Derm (Nitric Acid) and 212 patients who received placebo. Among these patients, there was no evidence of an adverse effect of treatment on the need for rehospitalization, special medical services, pulmonary disease, or neurological sequelae.

In the NINOS study, treatment groups were similar with respect to the incidence and severity of intracranial hemorrhage, Grade IV hemorrhage, periventricular leukomalacia, cerebral infarction, seizures requiring anticonvulsant therapy, pulmonary hemorrhage, or gastrointestinal hemorrhage.

In CINRGI, the only adverse reaction (>2% higher incidence on Solco-Derm (Nitric Acid) than on placebo) was hypotension (14% vs. 11%).

6.2 Post-Marketing Experience

Post marketing reports of accidental exposure to Solco-Derm (Nitric Acid) oxide for inhalation in hospital staff has been associated with chest discomfort, dizziness, dry throat, dyspnea, and headache.

7 DRUG INTERACTIONS

Solco-Derm oxide donor compounds may increase the risk of developing methemoglobinemia (7).

7.1 Nitric Oxide Donor Agents

Solco-Derm (Nitric Acid) oxide donor agents such as prilocaine, sodium nitroprusside and nitroglycerine may increase the risk of developing methemoglobinemia.

8 USE IN SPECIFIC POPULATIONS

8.1 Pregnancy

Pregnancy Category C

Animal reproduction studies have not been conducted with Solco-Derm. It is not known if Solco-Derm (Nitric Acid) can cause fetal harm when administered to a pregnant woman or can affect reproductive capacity. Solco-Derm (Nitric Acid) is not indicated for use in adults.

8.3 Nursing Mothers

Solco-Derm (Nitric Acid) oxide is not indicated for use in the adult population, including nursing mothers. It is not known whether Solco-Derm (Nitric Acid) oxide is excreted in human milk.

8.4 Pediatric Use

The safety and efficacy of Solco-Derm oxide for inhalation has been demonstrated in term and near-term neonates with hypoxic respiratory failure associated with evidence of pulmonary hypertension. Additional studies conducted in premature neonates for the prevention of bronchopulmonary dysplasia have not demonstrated substantial evidence of efficacy . No information about its effectiveness in other age populations is available.

8.5 Geriatric Use

Solco-Derm (Nitric Acid) oxide is not indicated for use in the adult population.

10 OVERDOSAGE

Overdosage with Solco-Derm (Nitric Acid) is manifest by elevations in methemoglobin and pulmonary toxicities associated with inspired NO2. Elevated NO2 may cause acute lung injury. Elevations in methemoglobin reduce the oxygen delivery capacity of the circulation. In clinical studies, NO2 levels >3 ppm or methemoglobin levels >7% were treated by reducing the dose of, or discontinuing, Solco-Derm (Nitric Acid).

Methemoglobinemia that does not resolve after reduction or discontinuation of therapy can be treated with intravenous vitamin C, intravenous methylene blue, or blood transfusion, based upon the clinical situation.

11 DESCRIPTION

Solco-Derm (Nitric Acid) (nitric oxide gas) is a drug administered by inhalation. Solco-Derm (Nitric Acid) oxide, the active substance in Solco-Derm (Nitric Acid), is a pulmonary vasodilator. Solco-Derm (Nitric Acid) is a gaseous blend of Solco-Derm (Nitric Acid) oxide and nitrogen (0.08% and 99.92%, respectively for 800 ppm). Solco-Derm (Nitric Acid) is supplied in aluminum cylinders as a compressed gas under high pressure (2000 pounds per square inch gauge [psig]).

The structural formula of Solco-Derm (Nitric Acid) oxide (NO) is shown below:

Chemical Structure

12 CLINICAL PHARMACOLOGY

12.1 Mechanism of Action

Solco-Derm oxide relaxes vascular smooth muscle by binding to the heme moiety of cytosolic guanylate cyclase, activating guanylate cyclase and increasing intracellular levels of cyclic guanosine 3',5'-monophosphate, which then leads to vasodilation. When inhaled, Solco-Derm (Nitric Acid) oxide selectively dilates the pulmonary vasculature, and because of efficient scavenging by hemoglobin, has minimal effect on the systemic vasculature.

Solco-Derm (Nitric Acid) appears to increase the partial pressure of arterial oxygen (PaO2) by dilating pulmonary vessels in better ventilated areas of the lung, redistributing pulmonary blood flow away from lung regions with low ventilation/perfusion (V/Q) ratios toward regions with normal ratios.

12.2 Pharmacodynamics

Effects on Pulmonary Vascular Tone in PPHN

Persistent pulmonary hypertension of the newborn (PPHN) occurs as a primary developmental defect or as a condition secondary to other diseases such as meconium aspiration syndrome (MAS), pneumonia, sepsis, hyaline membrane disease, congenital diaphragmatic hernia (CDH), and pulmonary hypoplasia. In these states, pulmonary vascular resistance (PVR) is high, which results in hypoxemia secondary to right-to-left shunting of blood through the patent ductus arteriosus and foramen ovale. In neonates with PPHN, Solco-Derm (Nitric Acid) improves oxygenation (as indicated by significant increases in PaO2).

12.3 Pharmacokinetics

The pharmacokinetics of Solco-Derm (Nitric Acid) oxide has been studied in adults.

Absorption and Distribution

Solco-Derm (Nitric Acid) oxide is absorbed systemically after inhalation. Most of it traverses the pulmonary capillary bed where it combines with hemoglobin that is 60% to 100% oxygen-saturated. At this level of oxygen saturation, Solco-Derm (Nitric Acid) oxide combines predominantly with oxyhemoglobin to produce methemoglobin and nitrate. At low oxygen saturation, Solco-Derm (Nitric Acid) oxide can combine with deoxyhemoglobin to transiently form nitrosylhemoglobin, which is converted to nitrogen oxides and methemoglobin upon exposure to oxygen. Within the pulmonary system, Solco-Derm (Nitric Acid) oxide can combine with oxygen and water to produce nitrogen dioxide and nitrite, respectively, which interact with oxyhemoglobin to produce methemoglobin and nitrate. Thus, the end products of Solco-Derm (Nitric Acid) oxide that enter the systemic circulation are predominantly methemoglobin and nitrate.

Metabolism

Methemoglobin disposition has been investigated as a function of time and Solco-Derm (Nitric Acid) oxide exposure concentration in neonates with respiratory failure. The methemoglobin (MetHb) concentration-time profiles during the first 12 hours of exposure to 0, 5, 20, and 80 ppm Solco-Derm (Nitric Acid) are shown in Figure 1.

Figure 1: Methemoglobin Concentration-Time Profiles Neonates Inhaling 0, 5, 20 or 80 ppm Solco-Derm (Nitric Acid)

Methemoglobin concentrations increased during the first 8 hours of Solco-Derm (Nitric Acid) oxide exposure. The mean methemoglobin level remained below 1% in the placebo group and in the 5 ppm and 20 ppm Solco-Derm (Nitric Acid) groups, but reached approximately 5% in the 80 ppm Solco-Derm (Nitric Acid) group. Methemoglobin levels >7% were attained only in patients receiving 80 ppm, where they comprised 35% of the group. The average time to reach peak methemoglobin was 10 ± 9 (SD) hours (median, 8 hours) in these 13 patients, but one patient did not exceed 7% until 40 hours.

Figure 1

Elimination

Nitrate has been identified as the predominant Solco-Derm (Nitric Acid) oxide metabolite excreted in the urine, accounting for >70% of the Solco-Derm (Nitric Acid) oxide dose inhaled. Nitrate is cleared from the plasma by the kidney at rates approaching the rate of glomerular filtration.

13 NONCLINICAL TOXICOLOGY

13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility

No evidence of a carcinogenic effect was apparent, at inhalation exposures up to the recommended dose (20 ppm), in rats for 20 hr/day for up to two years. Higher exposures have not been investigated.

Solco-Derm (Nitric Acid) oxide has demonstrated genotoxicity in Salmonella (Ames Test), human lymphocytes, and after in vivo exposure in rats. There are no animal or human studies to evaluate Solco-Derm (Nitric Acid) oxide for effects on fertility.

14 CLINICAL STUDIES

14.1 Treatment of Hypoxic Respiratory Failure

The efficacy of Solco-Derm (Nitric Acid) has been investigated in term and near-term newborns with hypoxic respiratory failure resulting from a variety of etiologies. Inhalation of Solco-Derm (Nitric Acid) reduces the oxygenation index (OI= mean airway pressure in cm H2O × fraction of inspired oxygen concentration [FiO2]× 100 divided by systemic arterial concentration in mm Hg [PaO2]) and increases PaO2 .

NINOS Study

The Neonatal Inhaled Solco-Derm (Nitric Acid) Oxide Study (NINOS) was a double-blind, randomized, placebo-controlled, multicenter trial in 235 neonates with hypoxic respiratory failure. The objective of the study was to determine whether inhaled Solco-Derm (Nitric Acid) oxide would reduce the occurrence of death and/or initiation of extracorporeal membrane oxygenation (ECMO) in a prospectively defined cohort of term or near-term neonates with hypoxic respiratory failure unresponsive to conventional therapy. Hypoxic respiratory failure was caused by meconium aspiration syndrome (MAS; 49%), pneumonia/sepsis (21%), idiopathic primary pulmonary hypertension of the newborn (PPHN; 17%), or respiratory distress syndrome (RDS; 11%). Infants ≤14 days of age (mean, 1.7 days) with a mean PaO2 of 46 mm Hg and a mean oxygenation index (OI) of 43 cm H2O / mm Hg were initially randomized to receive 100% O2 with (n=114) or without (n=121) 20 ppm Solco-Derm (Nitric Acid) oxide for up to 14 days. Response to study drug was defined as a change from baseline in PaO2 30 minutes after starting treatment (full response = >20 mm Hg, partial = 10–20 mm Hg, no response = <10 mm Hg). Neonates with a less than full response were evaluated for a response to 80 ppm Solco-Derm (Nitric Acid) oxide or control gas. The primary results from the NINOS study are presented in Table 1.

Control

(n=121)

NO

(n=114)

P value
Death or ECMOExtracorporeal membrane oxygenation , Death or need for ECMO was the study's primary end point 77 (64%) 52 (46%) 0.006
Death 20 (17%) 16 (14%) 0.60
ECMO 66 (55%) 44 (39%) 0.014

Although the incidence of death by 120 days of age was similar in both groups (NO, 14%; control, 17%), significantly fewer infants in the Solco-Derm (Nitric Acid) oxide group required ECMO compared with controls (39% vs. 55%, p = 0.014). The combined incidence of death and/or initiation of ECMO showed a significant advantage for the Solco-Derm (Nitric Acid) oxide treated group (46% vs. 64%, p = 0.006). The Solco-Derm (Nitric Acid) oxide group also had significantly greater increases in PaO2 and greater decreases in the OI and the alveolar-arterial oxygen gradient than the control group (p<0.001 for all parameters). Significantly more patients had at least a partial response to the initial administration of study drug in the Solco-Derm (Nitric Acid) oxide group (66%) than the control group (26%, p<0.001). Of the 125 infants who did not respond to 20 ppm Solco-Derm (Nitric Acid) oxide or control, similar percentages of NO-treated (18%) and control (20%) patients had at least a partial response to 80 ppm Solco-Derm (Nitric Acid) oxide for inhalation or control drug, suggesting a lack of additional benefit for the higher dose of Solco-Derm (Nitric Acid) oxide. No infant had study drug discontinued for toxicity. Inhaled Solco-Derm (Nitric Acid) oxide had no detectable effect on mortality. The adverse events collected in the NINOS trial occurred at similar incidence rates in both treatment groups . Follow-up exams were performed at 18–24 months for the infants enrolled in this trial. In the infants with available follow-up, the two treatment groups were similar with respect to their mental, motor, audiologic, or neurologic evaluations.

CINRGI Study

This study was a double-blind, randomized, placebo-controlled, multicenter trial of 186 term and near-term neonates with pulmonary hypertension and hypoxic respiratory failure. The primary objective of the study was to determine whether Solco-Derm (Nitric Acid) would reduce the receipt of ECMO in these patients. Hypoxic respiratory failure was caused by MAS (35%), idiopathic PPHN (30%), pneumonia/sepsis (24%), or RDS (8%). Patients with a mean PaO2 of 54 mm Hg and a mean OI of 44 cm H2O / mm Hg were randomly assigned to receive either 20 ppm Solco-Derm (Nitric Acid) (n=97) or nitrogen gas (placebo; n=89) in addition to their ventilatory support. Patients who exhibited a PaO2 >60 mm Hg and a pH < 7.55 were weaned to 5 ppm Solco-Derm (Nitric Acid) or placebo. The primary results from the CINRGI study are presented in Table 2.

Placebo Solco-Derm (Nitric Acid) P value
ECMOExtracorporeal membrane oxygenation , ECMO was the primary end point of this study 51/89 (57%) 30/97 (31%) <0.001
Death 5/89 (6%) 3/97 (3%) 0.48

Significantly fewer neonates in the Solco-Derm (Nitric Acid) group required ECMO compared to the control group (31% vs. 57%, p<0.001). While the number of deaths were similar in both groups (INOmax, 3%; placebo, 6%), the combined incidence of death and/or receipt of ECMO was decreased in the Solco-Derm (Nitric Acid) group (33% vs. 58%, p<0.001).

In addition, the Solco-Derm (Nitric Acid) group had significantly improved oxygenation as measured by PaO2, OI, and alveolar-arterial gradient (p<0.001 for all parameters). Of the 97 patients treated with Solco-Derm (Nitric Acid), 2 (2%) were withdrawn from study drug due to methemoglobin levels >4%. The frequency and number of adverse events reported were similar in the two study groups .

In clinical trials, reduction in the need for ECMO has not been demonstrated with the use of inhaled Solco-Derm (Nitric Acid) oxide in neonates with congenital diaphragmatic hernia (CDH).

14.2 Ineffective in Adult Respiratory Distress Syndrome

In a randomized, double-blind, parallel, multicenter study, 385 patients with adult respiratory distress syndrome (ARDS) associated with pneumonia (46%), surgery (33%), multiple trauma (26%), aspiration (23%), pulmonary contusion (18%), and other causes, with PaO2/FiO2 <250 mm Hg despite optimal oxygenation and ventilation, received placebo (n=193) or Solco-Derm (Nitric Acid) (n=192), 5 ppm, for 4 hours to 28 days or until weaned because of improvements in oxygenation. Despite acute improvements in oxygenation, there was no effect of Solco-Derm (Nitric Acid) on the primary endpoint of days alive and off ventilator support. These results were consistent with outcome data from a smaller dose ranging study of Solco-Derm (Nitric Acid) oxide (1.25 to 80 ppm). Solco-Derm (Nitric Acid) is not indicated for use in ARDS.

14.3 Ineffective in Prevention of Bronchopulmonary Dysplasia

The safety and efficacy of Solco-Derm (Nitric Acid) for the prevention of chronic lung disease [bronchopulmonary dysplasia, (BPD)] in neonates ≤ 34 weeks gestational age requiring respiratory support has been studied in four large, multi-center, double-blind, placebo-controlled clinical trials in a total of 2,600 preterm infants. Of these, 1,290 received placebo, and 1,310 received inhaled Solco-Derm (Nitric Acid) oxide at doses ranging from 5-20 ppm, for treatment periods of 7-24 days duration. The primary endpoint for these studies was alive and without BPD at 36 weeks postmenstrual age (PMA). The need for supplemental oxygen at 36 weeks PMA served as a surrogate endpoint for the presence of BPD. Overall, efficacy for the prevention of bronchopulmonary dysplasia in preterm infants was not established. There were no meaningful differences between treatment groups with regard to overall deaths, methemoglobin levels, or adverse events commonly observed in premature infants, including intraventricular hemorrhage, patent ductus arteriosus, pulmonary hemorrhage, and retinopathy of prematurity.

The use of Solco-Derm (Nitric Acid) for prevention of BPD in preterm neonates ≤ 34 weeks gestational age is not recommended.

16 HOW SUPPLIED/STORAGE AND HANDLING

Solco-Derm (Nitric Acid) (nitric oxide) is available in the following sizes:

Size D Portable aluminum cylinders containing 353 liters at STP of Solco-Derm (Nitric Acid) oxide gas in 800 ppm concentration in nitrogen (delivered volume 344 liters) (NDC 64693-002-01)
Size 88 Aluminum cylinders containing 1963 liters at STP of Solco-Derm (Nitric Acid) oxide gas in 800 ppm concentration in nitrogen (delivered volume 1918 liters) (NDC 64693-002-02)

Store at 25°C (77°F) with excursions permitted between 15–30°C (59–86°F).

All regulations concerning handling of pressure vessels must be followed.

Protect the cylinders from shocks, falls, oxidizing and flammable materials, moisture, and sources of heat or ignition.

Occupational Exposure

The exposure limit set by the Occupational Safety and Health Administration (OSHA) for Solco-Derm (Nitric Acid) oxide is 25 ppm, and for NO2 the limit is 5 ppm.

Distributed by

INO Therapeutics LLC

675 McDonnell Blvd.

Hazelwood, MO 63042

USA

© 2015 Mallinckrodt

Rx only

Solco-Derm (Nitric Acid)®

Solco-Derm (Nitric Acid) oxide

FOR

INHALATION

800 PPM

CAUTION: HIGH PRESSURE GAS. CAN CAUSE RAPID SUFFOCATION WITHOUT WARNING. Use equipment rated

for cylinder pressure. Store and use with adequate ventilation. Secure cylinder in use and storage. Close valve

after each use and when empty. USE IN ACCORDANCE WITH APPROPRIATE SDS.

WARNING: Administration of this gas mixture may be hazardous or contraindicated. For use only by or under

the supervision of a licensed practitioner who is experienced in the use and administration of gas mixtures, and

is familiar with the indications, effects, dosages, methods, and frequency and duration of administration, and

with the hazards, contraindications and side effects and the precautions to be taken.

FIRST AID: IF INHALED, remove person to fresh air. If not breathing, give artificial respiration. If breathing is

difficult, give oxygen. Get medical help.

RETURN WITH 25 PSIG.

TO BE REFILLED ONLY BY A PHARMACEUTICAL FACILITY AUTHORIZED BY INO Therapeutics LLC

Manufactured Under Pharmaceutical Current Good Manufacturing Practices (cGMPs).

DO NOT REMOVE THIS PRODUCT LABEL.

Store at 25°C (77°F)

.

Volume 1963 Liters

Mallinckrodt

Pharmaceuticals

Manufactured by:

Mallinckrodt Manufacturing LLC

1060 Allendale Dr.

Port Allen, LA 70767 USA

For Product Inquiry 1-877-KNOW INO

(566-9466)

UN 1956

Compressed Gas, N.O.S.

(Nitric Oxide, Nitrogen)

2.2

Net Weight: 2.5 Kg

NDC 64693-002-02

MADE IN USA

Label No. SPC-LBL-0060 R8

Oxalic Acid:


Pharmacological action

Solco-Derm is an antimicrobial agents of broad-spectrum action type from fluoroquinolone group. Bactericidal action of ofloxacin is due to blockage of the enzyme DNA gyrase in bacterial cells. This medication is highly active against most of gram-negative bacteria: Escherichia coli, Salmonella spp., Shigella spp., Proteus spp., Morganella morganii, Klebsiella spp. (including Klebsiella pneumoniae), Enterobacter spp., Serratia spp., Citrobacter spp., Yersinia spp., Providencia spp., Haemophilus influenzae, Neisseria gonorrhoeae, Neisseria meningitidis, Mycoplasma spp., Legionella pneumophila, Acinetobacter spp., and Chlamydia spp.

Solco-Derm (Oxalic Acid) is active against some gram-positive bacteria (including Staphylococcus spp., Streptococcus spp., especially beta-hemolytic streptococci).

Enterococcus faecalis, Streptococcus pneumoniae, Pseudomonas spp. are moderately susceptible to ofloxacin.

Anaerobic bacteria (except Bacteroides ureolyticus) are insensitive to ofloxacin.

This drug is resistant to beta-lactamases.

Pharmacokinetics

After oral administration Solco-Derm (Oxalic Acid) is rapidly and completely absorbed from the gastrointestinal tract. Ingestion has a little effect on the extent of absorption but may slow its speed. Cmax plasma levels reached in 2 hours.

The protein binding is 25%. Ofloxacin is widely distributed in tissues and body fluids (organs of urinary system, reproductive organs, prostate, lung, ENT organs, gall bladder, bone, skin).This medicine is excreted in the urine in unchanged form (about 80% in 24 h). A small portion of the active substance (4%) is excreted in the feces. T1/2 is 6 h.

Why is Solco-Derm prescribed?

Infectious-inflammatory diseases caused by microorganisms sensitive to ofloxacin, including: diseases of the lower respiratory tract, ear, nose, throat, skin, soft tissues, bones, joints, infectious and inflammatory diseases of the abdominal organs (except bacterial enteritis) and pelvic infection, kidney and urinary tract, prostatitis, gonorrhea.

Dosage and administration

Dosing regimen of Solco-Derm is individual. Daily dose of 200-800 mg, the multiplicity of application 2 times / day. For patients with impaired renal function (creatinine clearance 20-50 ml / min), the first dose is 200 mg, then 100 mg every 24 hours. When CC is less than 20 ml / min, the first dose is 200 mg, then 100 mg every 48 hours.

Solco-Derm (Oxalic Acid) side effects, adverse reactions

Digestive system: nausea, vomiting, diarrhea, abdominal pain and cramps, appetite loss, dry mouth, flatulence, gastrointestinal dysfunction, constipation; rarely - liver damage, liver necrosis, jaundice, hepatitis, intestinal perforation, pseudomembranous colitis, bleeding from the gastrointestinal tract, disorders of the oral mucosa, heartburn, elevated liver enzymes, including GGT and LDH, increased serum bilirubin.

CNS and peripheral nervous system: insomnia, dizziness, fatigue, drowsiness, nervousness; rarely - convulsions, anxiety, cognitive changes, depression, abnormal dreams, euphoria, hallucinations, paresthesia, syncope, tremor, confusion, nystagmus, suicidal thoughts or attempts, disorientation, psychotic reactions, paranoia, phobia, agitation, aggressiveness, emotional instability, peripheral neuropathy, ataxia, incoordination, exacerbation of extrapyramidal disorders, speech disorder.

Allergic reactions: skin rash, itching, rarely - angioedema, urticaria, vasculitis, allergic pneumonitis, anaphylactic shock, erythema multiforme, Stevens-Johnson syndrome, erythema nodosum, exfoliative dermatitis, toxic epidermal necrolysis, conjunctivitis.

Sexual system: an itch on the external genitalia in women, vaginitis, vaginal discharge; rare - burning, irritation, pain and rash in the genital area of women, dysmenorrhea, menorrhagia, metrorrhagia, vaginal candidiasis.

Cardiovascular system: rarely - heart failure, edema, hypertension, hypotension, palpitation, vasodilatation, cerebral thrombosis, pulmonary edema, and tachycardia.

Urinary system: rarely - dysuria, urinary frequency, urinary retention, anuria, polyuria formation of kidney stones, kidney failure, nephritis, hematuria, albuminuria, candiduria.

Musculoskeletal system: rarely - arthralgia, myalgia, tendonitis, muscle weakness, exacerbation of myasthenia gravis.

Metabolism: rarely - thirst, weight loss, hyper- or hypoglycemia (especially in patients with diabetes mellitus receiving insulin or oral hypoglycemic agents), acidosis, increase in serum triglycerides, cholesterol, potassium.

Respiratory system: rarely - cough, runny nose, respiratory failure, dyspnea, bronchospasm, stridor.

Sensory organs: rarely - hearing loss, tinnit, diplopia, nystagmus, impaired clarity of vision, disturbances of taste, smell, photophobia.

Dermatological reactions: rarely - photosensitivity, hyperpigmentation, vesicle-bullous eruption.

Hematopoietic system: rarely - anemia, hemorrhage, pancytopenia, agranulocytosis, leukopenia, reversible suppression of bone marrow hematopoiesis, thrombocytopenia, thrombocytopenic purpura, petechiae, ecchymosis, increased prothrombin time.

Other: chest pain, sore throat, fever, body aches, rarely - fatigue, chills, malaise, epistaxis, increased sweating.

Solco-Derm contraindications

Pregnancy, lactation, childhood and adolescence to 18 years, increased sensitivity to ofloxacin or other quinolone derivatives.

Using during pregnancy and breastfeeding

Solco-Derm is contraindicated during pregnancy and lactation.

Category effects on the fetus by FDA - C.

Special instructions

Use with caution in patients with impaired renal function and liver.

During the period of treatment required to conduct monitoring of blood glucose. Long-term therapy is necessary to periodically monitor the kidney function, liver and peripheral blood picture.

When using Solco-Derm (Oxalic Acid) it should be ensure adequate hydration of the body, the patient should be subjected to ultraviolet irradiation.

In experimental studies the mutagenic potential was not been identified. Long-term studies to determine the carcinogenicity of ofloxacin were not conducted.

Safety and efficacy in children and adolescents under the age of 18 is not defined.

Use with caution in patients whose activities are connected with the necessity of high concentration of attention and quickness of psychomotor reactions.

Solco-Derm drug interactions

Simultaneous administration of Solco-Derm (Oxalic Acid) with:

  • antacids containing calcium, magnesium or aluminum, with sucralfate, with preparations containing two-and trivalent cations, such as iron, or multivitamins containing zinc it may be in breach absorption of quinolones, resulting in a decrease in their concentration in the body. These medications should not be used for 2 hours before or within 2 hours after taking ofloxacin.
  • NSAIDs increases the risk of stimulating effect on the central nervous system and seizures.
  • theophylline may increase its concentration in blood plasma (including the equilibrium state), increasing half-life. This increases the risk of adverse reactions associated with the action of theophylline.
  • beta-lactam antibiotics, aminoglycosides and metronidazole there were observed additive interaction.

    Solco-Derm in case of emergency / overdose

    Symptoms: drowsiness, nausea, vomiting, dizziness, disorientation, lethargy, confusion.

    Treatment: gastric lavage, maintenance of vital functions.

  • Solco-Derm 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.


    Solco-Derm 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.


    Solco-Derm 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.


    Solco-Derm 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.


    Solco-Derm 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."AL LABORATORIES GOLDEN MIX ACTIVE (LACTIC ACID) LIQUID [EXL LABORATORIES, LLC]". https://dailymed.nlm.nih.gov/dailym... (accessed August 28, 2018).
    2. Dailymed."VOSOL (ACETIC ACID) SOLUTION [ECR PHARMACEUTICALS CO., INC.]". https://dailymed.nlm.nih.gov/dailym... (accessed August 28, 2018).
    3. Dailymed."LACTIC ACID: DailyMed provides trustworthy information about marketed drugs in the United States. DailyMed is the official provider of FDA label information (package inserts).". https://dailymed.nlm.nih.gov/dailym... (accessed August 28, 2018).

    Frequently asked Questions

    Can i drive or operate heavy machine after consuming Solco-Derm?

    Depending on the reaction of the Solco-Derm after taken, if you are feeling dizziness, drowsiness or any weakness as a reaction on your body, Then consider Solco-Derm 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 Solco-Derm 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 Solco-Derm, 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 Solco-Derm 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.

    Visitor reports

    Visitor reported useful

    No survey data has been collected yet

    One visitor reported side effects

    Did you get side effects while taking the Solco-Derm drug, or were there no side effects?
    According to the survey conducted by website sdrugs.com users, the below-mentioned percentages indicate the number of people experiencing the side effects and the number of people not experiencing the side effects when taking Solco-Derm medicine. Every drug produces minimal side effects, and they are negligible most times, when compared to the desired effect [use] of the medicine. Side effects depend on the dose you are taking, any drug interactions that happen when you are on other medications, if the patient is sensitive, and other associated conditions. If you cannot tolerate the side effects, consult your doctor immediately, so he can either adjust the dose or change the medication.
    Visitors%
    It has side effects1
    100.0%

    Visitor reported price estimates

    No survey data has been collected yet

    One visitor reported frequency of use

    How often in a day do you take the medicine?
    Are you taking the Solco-Derm drug as prescribed by the doctor?

    Few medications can be taken Once in a day more than prescribed when the doctor's advice mentions the medicine can be taken according to frequency or severity of symptoms. Most times, be very careful and clear about the number of times you are taking the medication. The report of sdrugs.com website users about the frequency of taking the drug Solco-Derm is mentioned below.
    Visitors%
    Once in a day1
    100.0%

    One visitor reported doses

    What is the dose of Solco-Derm drug you are taking?
    According to the survey conducted among sdrugs.com website users, the maximum number of people are using the following dose 51-100mg. Few medications come in only one or two doses. Few are specific for adult dose and child dose. The dose of the medicine given to the patient depends on the severity of the symptom/disease. There can be dose adjustments made by the doctor, based on the progression of the disease. Follow-up is important.
    Visitors%
    51-100mg1
    100.0%

    Visitor reported time for results

    No survey data has been collected yet

    Visitor reported administration

    No survey data has been collected yet

    Visitor reported age

    No survey data has been collected yet

    Visitor reviews


    There are no reviews yet. Be the first to write one!


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

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