Cafcit

caffeine citrate

Dosage Form: injection, oral solution
Cafcit (caffeine citrate) Injection and Cafcit (caffeine citrate) Oral Solution

Rx ONLY

Cafcit Description

Both Cafcit® (caffeine citrate) Injection for intravenous administration and Cafcit® (caffeine citrate) Oral Solution are clear, colorless, sterile, non-pyrogenic, preservative-free, aqueous solutions adjusted to pH 4.7. Each mL contains 20 mg caffeine citrate (equivalent to 10 mg of caffeine base) prepared in solution by the addition of 10 mg caffeine anhydrous to 5.0 mg citric acid monohydrate, 8.3 mg sodium citrate dihydrate and Water for Injection.

Caffeine, a central nervous system stimulant, is an odorless white crystalline powder or granule, with a bitter taste. It is sparingly soluble in water and ethanol at room temperature. The chemical name of caffeine is 3,7-dihydro-1,3,7-trimethyl-1H-purine-2,6-dione. In the presence of citric acid it forms caffeine citrate salt in solution. The structural formula and molecular weight of caffeine citrate follows.

Caffeine citrate

C14H18N4O9 Mol. Wt. 386.31

Cafcit - Clinical Pharmacology

Mechanism of Action

Caffeine is structurally related to other methylxanthines, theophylline, and theobromine. It is a bronchial smooth muscle relaxant, a CNS stimulant, a cardiac muscle stimulant, and a diuretic.

Although the mechanism of action of caffeine in apnea of prematurity is not known, several mechanisms have been hypothesized. These include: (1) stimulation of the respiratory center, (2) increased minute ventilation, (3) decreased threshold to hypercapnia, (4) increased response to hypercapnia, (5) increased skeletal muscle tone, (6) decreased diaphragmatic fatigue, (7) increased metabolic rate, and (8) increased oxygen consumption.

Most of these effects have been attributed to antagonism of adenosine receptors, both A1 and A2 subtypes, by caffeine, which has been demonstrated in receptor binding assays and observed at concentrations approximating those achieved therapeutically.

Pharmacokinetics

Absorption

After oral administration of 10 mg caffeine base/kg to preterm neonates, the peak plasma level (Cmax) for caffeine ranged from 6-10 mg/L and the mean time to reach peak concentration (Tmax) ranged from 30 minutes to 2 hours. The Tmax was not affected by formula feeding. The absolute bioavailability, however, was not fully examined in preterm neonates.

Distribution

Caffeine is rapidly distributed into the brain. Caffeine levels in the cerebrospinal fluid of preterm neonates approximate their plasma levels. The mean volume of distribution of caffeine in infants (0.8-0.9 L/kg) is slightly higher than that in adults (0.6 L/kg). Plasma protein binding data are not available for neonates or infants. In adults, the mean plasma protein binding in vitro is reported to be approximately 36%.

Metabolism

Hepatic cytochrome P4501A2 (CYP1A2) is involved in caffeine biotransformation. Caffeine metabolism in preterm neonates is limited due to their immature hepatic enzyme systems.

Interconversion between caffeine and theophylline has been reported in preterm neonates; caffeine levels are approximately 25% of theophylline levels after theophylline administration and approximately 3-8% of caffeine administered would be expected to convert to theophylline.

Elimination

In young infants, the elimination of caffeine is much slower than that in adults due to immature hepatic and/or renal function. Mean half-life (T1/2) and fraction excreted unchanged in urine (Ae) of caffeine in infants have been shown to be inversely related to gestational/postconceptual age. In neonates, the T1/2 is approximately 3-4 days and the Ae is approximately 86% (within 6 days). By 9 months of age, the metabolism of caffeine approximates that seen in adults (T1/2 = 5 hours and Ae = 1%).

Special Populations

Studies examining the pharmacokinetics of caffeine in neonates with hepatic or renal insufficiency have not been conducted. Cafcit (caffeine citrate) should be administered with caution in preterm neonates with impaired renal or hepatic function. Serum concentrations of caffeine should be monitored and dose administration of Cafcit should be adjusted to avoid toxicity in this population.

Clinical Studies

One multicenter, randomized, double-blind trial compared Cafcit (caffeine citrate) to placebo in eighty five (85) preterm infants (gestational age 28 to <33 weeks) with apnea of prematurity. Apnea of prematurity was defined as having at least 6 apnea episodes of greater than 20 seconds duration in a 24-hour period with no other identifiable cause of apnea. A 1 mL/kg (20 mg/kg caffeine citrate providing 10 mg/kg as caffeine base) loading dose of Cafcit was administered intravenously, followed by a 0.25 mL/kg (5 mg/kg caffeine citrate providing 2.5 mg/kg of caffeine base) daily maintenance dose administered either intravenously or orally (generally through a feeding tube). The duration of treatment in this study was limited to 10 to 12 days. The protocol allowed infants to be "rescued" with open-label caffeine citrate treatment if their apnea remained uncontrolled during the double-blind phase of the trial.

The percentage of patients without apnea on day 2 of treatment (24-48 hours after the loading dose) was significantly greater with Cafcit than placebo. The following table summarizes the clinically relevant endpoints evaluated in this study:

 

	Cafcit	Placebo	p-value
Number of patients evaluated1	45	37
% of patients with zero apnea events on day 2	26.7	8.1	0.03
Apnea rate on day 2 (per 24 h)	4.9	7.2	0.134
% of patients with 50% reduction in apnea events from baseline on day 2	76	57	0.07

1 Of 85 patients who received drug, 3 were not included in the efficacy analysis because they had <6 apnea episodes/24 hours at baseline.

In this 10-12 day trial, the mean number of days with zero apnea events was 3.0 in the Cafcit group and 1.2 in the placebo group. The mean number of days with a 50% reduction from baseline in apnea events was 6.8 in the Cafcit group and 4.6 in the placebo group.

Indications and Usage for Cafcit

Cafcit (caffeine citrate) is indicated for the short-term treatment of apnea of prematurity in infants between 28 and <33 weeks gestational age.

Contraindications

Cafcit (caffeine citrate) is contraindicated in patients who have demonstrated hypersensitivity to any of its components.

Warnings

During the double-blind, placebo-controlled clinical trial, 6 cases of necrotizing enterocolitis developed among the 85 infants studied (caffeine=46, placebo=39), with 3 cases resulting in death. Five of the six patients with necrotizing enterocolitis were randomized to or had been exposed to Cafcit (caffeine citrate).

Reports in the published literature have raised a question regarding the possible association between the use of methylxanthines and development of necrotizing enterocolitis, although a causal relationship between methylxanthine use and necrotizing enterocolitis has not been established. Therefore, as with all preterm infants, patients being treated with Cafcit should be carefully monitored for the development of necrotizing enterocolitis.

Precautions

General

Apnea of prematurity is a diagnosis of exclusion. Other causes of apnea (e.g., central nervous system disorders, primary lung disease, anemia, sepsis, metabolic disturbances, cardiovascular abnormalities, or obstructive apnea) should be ruled out or properly treated prior to initiation of Cafcit (caffeine citrate).

Caffeine is a central nervous system stimulant and in cases of caffeine overdose, seizures have been reported. Cafcit should be used with caution in infants with seizure disorders.

The duration of treatment of apnea of prematurity in the placebo-controlled trial was limited to 10 to 12 days. The safety and efficacy of Cafcit for longer periods of treatment have not been established. Safety and efficacy of Cafcit for use in the prophylactic treatment of sudden infant death syndrome (SIDS) or prior to extubation in mechanically ventilated infants have also not been established.

Cardiovascular

Although no cases of cardiac toxicity were reported in the placebo-controlled trial, caffeine has been shown to increase heart rate, left ventricular output, and stroke volume in published studies. Therefore, Cafcit should be used with caution in infants with cardiovascular disease.

Renal and Hepatic Systems

Cafcit should be administered with caution in infants with impaired renal or hepatic function. Serum concentrations of caffeine should be monitored and dose administration of Cafcit should be adjusted to avoid toxicity in this population. (See CLINICAL PHARMACOLOGY, Elimination, Special Populations.)

Information for patients

Parents/caregivers of patients receiving Cafcit (caffeine citrate) Oral Solution should receive the following instructions:

1. Cafcit does not contain any preservatives and each vial is for single use only. Any unused portion of the medication should be discarded.

2. It is important that the dose of Cafcit be measured accurately, i.e., with a 1cc or other appropriate syringe.

3. Consult your physician if the baby continues to have apnea events; do not increase the dose of Cafcit without medical consultation.

4. Consult your physician if the baby begins to demonstrate signs of gastrointestinal intolerance, such as abdominal distention, vomiting, or bloody stools, or seems lethargic.

5. Cafcit should be inspected visually for particulate matter and discoloration prior to its administration. Vials containing discolored solution or visible particulate matter should be discarded.

Laboratory tests

Prior to initiation of Cafcit (caffeine citrate), baseline serum levels of caffeine should be measured in infants previously treated with theophylline, since preterm infants metabolize theophylline to caffeine. Likewise, baseline serum levels of caffeine should be measured in infants born to mothers who consumed caffeine prior to delivery, since caffeine readily crosses the placenta.

In the placebo-controlled clinical trial, caffeine levels ranged from 8 to 40 mg/L. A therapeutic plasma concentration range of caffeine could not be determined from the placebo-controlled clinical trial. Serious toxicity has been reported in the literature when serum caffeine levels exceed 50 mg/L. Serum concentrations of caffeine may need to be monitored periodically throughout treatment to avoid toxicity.

In clinical studies reported in the literature, cases of hypoglycemia and hyperglycemia have been observed. Therefore, serum glucose may need to be periodically monitored in infants receiving Cafcit.

Interactions

Drug interactions

Cytochrome P450 1A2 (CYP1A2) is known to be the major enzyme involved in the metabolism of caffeine. Therefore, caffeine has the potential to interact with drugs that are substrates for CYP1A2, inhibit CYP1A2, or induce CYP1A2.

Few data exist on drug interactions with caffeine in preterm neonates. Based on adult data, lower doses of caffeine may be needed following coadministration of drugs which are reported to decrease caffeine elimination (e.g., cimetidine and ketoconazole) and higher caffeine doses may be needed following coadministration of drugs that increase caffeine elimination (e.g., phenobarbital and phenytoin).

Caffeine administered concurrently with ketoprofen reduced the urine volume in four healthy volunteers. The clinical significance of this interaction in preterm neonates is not known.

Interconversion between caffeine and theophylline has been reported in preterm neonates. The concurrent use of these drugs is not recommended.

Carcinogenesis, mutagenesis, impairment of fertility

In a 2-year study in Sprague-Dawley rats, caffeine (as caffeine base) administered in drinking water was not carcinogenic in male rats at doses up to 102 mg/kg or in female rats at doses up to 170 mg/kg (approximately 2 and 4 times, respectively, the maximum recommended intravenous loading dose for infants on a mg/m2 basis). In an 18-month study in C57BL/6 mice, no evidence of tumorigenicity was seen at dietary doses up to 55 mg/kg (less than the maximum recommended intravenous loading dose for infants on a mg/m2 basis).

Caffeine (as caffeine base) increased the sister chromatid exchange (SCE) SCE/cell metaphase (exposure time dependent) in an in vivo mouse metaphase analysis. Caffeine also potentiated the genotoxicity of known mutagens and enhanced the micronuclei formation (5-fold) in folate-deficient mice. However, caffeine did not increase chromosomal aberrations in in vitro Chinese hamster ovary cell (CHO) and human lymphocyte assays and was not mutagenic in an in vitro CHO/hypoxanthine guanine phosphoribosyltransferase (HGPRT) gene mutation assay, except at cytotoxic concentrations. In addition, caffeine was not clastogenic in an in vivo mouse micronucleus assay.

Caffeine (as caffeine base) administered to male rats at 50 mg/kg/day subcutaneously (approximately equal to the maximum recommended intravenous loading dose for infants on a mg/m2 basis) for 4 days prior to mating with untreated females, caused decreased male reproductive performance in addition to causing embryotoxicity. In addition, long-term exposure to high oral doses of caffeine (3.0 g over 7 weeks) was toxic to rat testes as manifested by spermatogenic cell degeneration.

Pregnancy

Pregnancy Category C

Concern for the teratogenicity of caffeine is not relevant when administered to infants. In studies performed in adult animals, caffeine (as caffeine base) administered to pregnant mice as sustained release pellets at 50 mg/kg (less than the maximum recommended intravenous loading dose for infants on a mg/m2 basis), during the period of organogenesis, caused a low incidence of cleft palate and exencephaly in the fetuses. There are no adequate and well-controlled studies in pregnant women.

Adverse Reactions

Overall, the reported number of adverse events in the double-blind period of the controlled trial was similar for the Cafcit (caffeine citrate) and placebo groups. The following table shows adverse events that occurred in the double-blind period of the controlled trial and that were more frequent in Cafcit-treated patients than placebo.

ADVERSE EVENTS THAT OCCURRED MORE FREQUENTLY IN Cafcit-TREATED PATIENTS THAN PLACEBO DURING DOUBLE-BLIND THERAPY

Adverse Event (AE)	Cafcit N=46 n (%)	Placebo N=39 n (%)
BODY AS A WHOLE
Accidental Injury	1 (2.2)	0 (0.0)
Feeding Intolerance	4 (8.7)	2 (5.1)
Sepsis	2 (4.3)	0 (0.0)
CARDIOVASCULAR SYSTEM
Hemorrhage	1 (2.2)	0 (0.0)
DIGESTIVE SYSTEM
Necrotizing Enterocolitis	2 (4.3)	1 (2.6)
Gastritis	1 (2.2)	0 (0.0)
Gastrointestinal Hemorrhage	1 (2.2)	0 (0.0)
HEMIC AND LYMPHATIC SYSTEM
Disseminated Intravascular Coagulation	1 (2.2)	0 (0.0)
METABOLIC AND NUTRITIVE DISORDERS
Acidosis	1 (2.2)	0 (0.0)
Healing Abnormal	1 (2.2)	0 (0.0)
NERVOUS SYSTEM
Cerebral Hemorrhage	1 (2.2)	0 (0.0)
RESPIRATORY SYSTEM
Dyspnea	1 (2.2)	0 (0.0)
Lung Edema	1 (2.2)	0 (0.0)
SKIN AND APPENDAGES
Dry Skin	1 (2.2)	0 (0.0)
Rash	4 (8.7)	3 (7.7)
Skin Breakdown	1 (2.2)	0 (0.0)
SPECIAL SENSES
Retinopathy of Prematurity	1 (2.2)	0 (0.0)
UROGENITAL SYSTEM
Kidney Failure	1 (2.2)	0 (0.0)

In addition to the cases above, three cases of necrotizing enterocolitis were diagnosed in patients receiving Cafcit (caffeine citrate) during the open-label phase of the study.

Three of the infants who developed necrotizing enterocolitis during the trial died. All had been exposed to caffeine. Two were randomized to caffeine, and one placebo patient was “rescued” with open-label caffeine for uncontrolled apnea.

Adverse events described in the published literature include: central nervous system stimulation (ie, irritability, restlessness, jitteriness), cardiovascular effects (ie, tachycardia, increased left ventricular output, and increased stroke volume), gastrointestinal effects (ie, increased gastric aspirate, gastrointestinal intolerance), alterations in serum glucose (ie, hypoglycemia and hyperglycemia), and renal effects (ie, increased urine flow rate, increased creatinine clearance, and increased sodium and calcium excretion). Published long-term follow-up studies have not shown caffeine to adversely affect neurological development or growth parameters.

Overdosage

Following overdose, serum caffeine levels have ranged from approximately 24 mg/L (a postmarketing spontaneous case report in which an infant exhibited irritability, poor feeding, and insomnia) to 350 mg/L. Serious toxicity has been associated with serum levels greater than 50 mg/L (see PRECAUTIONS – Laboratory testsand DOSAGE AND ADMINISTRATION). Signs and symptoms reported in the literature after caffeine overdose in preterm infants include fever, tachypnea, jitteriness, insomnia, fine tremor of the extremities, hypertonia, opisthotonos, tonic-clonic movements, nonpurposeful jaw and lip movements, vomiting, hyperglycemia, elevated blood urea nitrogen, and elevated total leukocyte concentration. Seizures have also been reported in cases of overdose. One case of caffeine overdose complicated by development of intraventricular hemorrhage and long-term neurological sequelae has been reported. Another case of caffeine citrate overdose (from New Zealand; not Cafcit) of an estimated 600 mg caffeine citrate (approximately 322 mg/kg) administered over 40 minutes was complicated by tachycardia, ST depression, respiratory distress, heart failure, gastric distention, acidosis, and a severe extravasation burn with tissue necrosis at the peripheral intravenous injection site. No deaths associated with caffeine overdose have been reported in preterm infants.

Treatment of caffeine overdose is primarily symptomatic and supportive. Caffeine levels have been shown to decrease after exchange transfusions. Convulsions may be treated with intravenous administration of diazepam or a barbiturate such as pentobarbital sodium.

Cafcit Dosage and Administration

Prior to initiation of Cafcit (caffeine citrate), baseline serum levels of caffeine should be measured in infants previously treated with theophylline, since preterm infants metabolize theophylline to caffeine. Likewise, baseline serum levels of caffeine should be measured in infants born to mothers who consumed caffeine prior to delivery, since caffeine readily crosses the placenta.

The recommended loading dose and maintenance doses of Cafcit follow.

	Dose of Cafcit (caffeine citrate) Volume	Dose of Cafcit (caffeine citrate) mg/kg	Route	Frequency
Loading Dose	1 mL/kg	20 mg/kg	Intravenous* (over 30 minutes)	One Time
Maintenance Dose	0.25 mL/kg	5 mg/kg	Intravenous* (over 10 minutes) or Orally	Every 24 hours**

*using a syringe infusion pump

**beginning 24 hours after the loading dose

NOTE THAT THE DOSE OF CAFFEINE BASE IS ONE-HALF THE DOSE WHEN EXPRESSED AS CAFFEINE CITRATE (e.g., 20 mg of caffeine citrate is equivalent to 10 mg of caffeine base).

Serum concentrations of caffeine may need to be monitored periodically throughout treatment to avoid toxicity. Serious toxicity has been associated with serum levels greater than 50 mg/L.

Cafcit should be inspected visually for particulate matter and discoloration prior to administration. Vials containing discolored solution or visible particulate matter should be discarded.

Drug Compatibility

To test for drug compatibility with common intravenous solutions or medications, 20 mL of Cafcit (caffeine citrate) Injection were combined with 20 mL of a solution or medication, with the exception of an Intralipid® admixture, which was combined as 80 mL/80 mL. The physical appearance of the combined solutions was evaluated for precipitation. The admixtures were mixed for 10 minutes and then assayed for caffeine. The admixtures were then continually mixed for 24 hours, with further sampling for caffeine assays at 2, 4, 8, and 24 hours.

Based on this testing, Cafcit (caffeine citrate) Injection, 60 mg/3 mL is chemically stable for 24 hours at room temperature when combined with the following test products.

• Dextrose Injection, USP 5%

• 50% Dextrose Injection USP

• Intralipid® 20% IV Fat Emulsion

• Aminosyn® 8.5% Crystalline Amino Acid Solution

• Dopamine HCI Injection, USP 40 mg/mL diluted to 0.6 mg/mL with Dextrose Injection, USP 5% • Calcium Gluconate Injection, USP 10% (0.465 mEq/Ca+2/mL)

• Heparin Sodium Injection, USP 1000 units/mL diluted to 1 unit/mL with Dextrose Injection, USP 5%

• Fentanyl Citrate Injection, USP 50 μg/mL diluted to 10 μg/mL with Dextrose Injection, USP 5%

How is Cafcit Supplied

Both Cafcit (caffeine citrate) Injection and Cafcit Oral Solution are available as clear, colorless, sterile, non-pyrogenic, preservative-free, aqueous solutions in 3 mL colorless glass vials. The vials of Cafcit Injection are sealed with a teflon-faced gray rubber stopper and an aluminum overseal with a white flip-off polypropylene disk inset. The vials of Cafcit Oral Solution are sealed with a teflon-faced gray rubber stopper and a peel-off aluminum overseal with a blue flip-off polypropylene disk inset.

Both the injection and oral solution vials contain 3 mL solution at a concentration of 20 mg/mL caffeine citrate (60 mg/vial) equivalent to 10 mg/mL caffeine base (30 mg/vial).

Cafcit® (caffeine citrate) Injection

NDC 55390-357-03: 3 mL vial, individually packaged in a carton.

Cafcit® (caffeine citrate) Oral Solution

NDC 55390-358-03: 3 mL vial (NOT CHILD-RESISTANT),

10 vials per white polypropylene child-resistant container.

Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.]

Preservative free. For single use only. Discard unused portion.

ATTENTION PHARMACIST: Detach "Instructions for Use" from the package insert and dispense with Cafcit (caffeine citrate) Oral Solution prescription.

Manufactured by: Ben Venue Laboratories, Inc., Bedford, OH 44146

Manufactured for: Bedford Laboratories™, Bedford, OH 44146

November 2009

CFCO-P01

Cafcit® (caffeine citrate) Oral Solution

Rx ONLY

Each bottle (vial) of Cafcit® contains a total of 60 mg of caffeine citrate in 3 mL (20 mg/mL).

Information and Instructions for Use

This leaflet tells you about CAFClT (KAF-sit) and how to give it to your baby. Read the following information before giving this medicine to your baby. Completely discuss Cafcit with your baby’s doctor. Continue to discuss any questions you have about this medicine at your baby’s checkups.

After you remove your baby’s dose, throw away the open bottle (vial) and all medicine leftin it. Use each vial of Cafcit for only one dose. There will be extra medicine left in the vial afte one dose is removed. Leftover medicine should not be used because Cafcit does not contain preservatives. Once the vial is open, any medicine that is not used right away must be discarded.

What is Cafcit?

The main ingredient of Cafcit is caffeine citrate. Cafcit is a clear, colorless, medicine to treat apnea of prematurity—short periods when premature babies stop breathing. Apnea of prematurity is due to the baby’s breathing centers not being fully developed.

How do I give Cafcit to my baby?

Give Cafcit to your baby once a day, at about the same time each day. Your baby’s doctor will prescribe the right amount of Cafcit based on your baby’s weight and age. Carefully follow the doctor’s dosing instructions.

Measure the dose of Cafcit carefully. Your baby’s doctor, nurse, or pharmacist will give you a suitable syringe or supply of syringes to measure small but accurate doses of Cafcit.

Never change (increase or decrease) your baby’s dose without speaking to your baby’s doctor.

If your baby continues to have periods of apnea, call your baby’s doctor right away.

Cafcit can be swallowed by mouth or given through a feeding tube. Based on your baby’s own situation, your baby’s doctor or other healthcare professional should teach you how to give Cafcit correctly.

Cafcit should be clear and colorless. Before giving Cafcit, look for small particles, cloudiness, or discoloration in the medicine. Do not use vials that contain cloudy or discolored medicine, orany visible particles.

Cafcit does NOT contain any preservatives. Do not open the vial until it is time for your baby to receive the dose of medicine. Use each vial only once. After you remove your baby’s dose, throw away the vial and all medicine left in the opened vial.

Ten (10) vials of Cafcit are packaged in a child-resistant container. CAFClT vials are NOT CHILD RESISTANT. Always store vials of Cafcit in the child-resistant container. Follow the instructions below to open the child-resistant container, to open a vial of Cafcit, and to remove a dose of medicine from the vial.

To open the child-resistant container that holds the vials of Cafcit:

(Instructions with pictures are also printed on the top of the container.)

1. Hold the bottom half of the child-resistant container with one hand and push the lower semicircular section on the front of the container with your thumb.

2. With your other hand, pull the cover up until you hear it click.

3. While holding the ends of the bottom half of the container with both hands, place both index fingers on the two semicircular locking tabs on the sides of the container.

4. Press the two tabs and raise the cover up.

To open a vial of Cafcit:

1. Hold the blue plastic top between the thumb and index finger. Use your thumb to flip the blue plastic top completely off the vial.

2. Carefully lift up the metal ring.

3. Pull the metal ring away from the vial and then pull it down towards the bottom of the vial without twisting the ring.

4. After you pull the ring down and the metal band around the top of the vial is completely broken through, carefully remove the rest of the metal band by pulling it out and away from the vial.

5. Being careful not to spill any medicine, remove the rubber stopper from the top of the vial.

To remove the prescribed dose from the vial:

You will need a small syringe to measure the exact amount of medicine that your baby’s doctor prescribed. Your baby’s doctor, nurse or pharmacist will give you this small syringe. Note that a milliliter (mL) is the same as a cubic centimeter (cc).

1. Insert the tip of the syringe in the medicine and pull up on the plunger to draw the medicine into the syringe. Remove slightly more of the medicine than the exact amount to be given to your baby.

2. Turn the syringe tip up so that any air in it rises to the top. Remove the air by gently pushing up on the syringe plunger. Continue to push the syringe plunger up to remove any extra medicine in the syringe, until only the exact number of milliliters (or cubic centimeters) that your baby’s doctor prescribed remains in the syringe.

3. Give the Cafcit to your baby as your baby’s doctor instructed.

4. Throw away the sharp metal pieces, the rubber stopper, the open vial, and any medicine that remains in it after your baby receives the dose.

What are possible side effects of Cafcit?

Your baby may or may not develop side effects from taking Cafcit. Each baby is different. If your baby develops one or more of the following symptoms, speak with your baby’s doctor right away:

• restlessness, jitteriness, or shakiness

• faster heart beat

• increased urination (increased diaper wetting)

The following symptoms may be caused by serious bowel or stomach problems. Call your baby’s doctor right away if your baby develops:

• bloated abdomen (stomach area)

• vomiting

• bloody stools (bloody bowel movements)

• loss of energy, lethargy (acting sluggish)

This is not a complete list of side effects reported with Cafcit. If you have a concern about your baby, speak with your baby’s doctor. If you want more information about Cafcit, speak with your baby’s doctor or pharmacist.

Manufactured for: Bedford Laboratories™, Bedford, OH 44146

CFCO-P01

November 2009

VIAL LABEL (Injection)

Vial Label (Injection) 60 mg/3 mL

VIAL LABEL (Oral Solution)

Vial Label (Oral Solution) 60 mg/3 mL

Cafcit  caffeine citrate  injection

Product Information Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 55390-357 Route of Administration INTRAVENOUS DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength CAFFEINE CITRATE (CAFFEINE) CAFFEINE CITRATE 20 mg  in 1 mL

Inactive Ingredients Ingredient Name Strength CITRIC ACID MONOHYDRATE 5 mg  in 1 mL SODIUM CITRATE 8.3 mg  in 1 mL WATER

Product Characteristics Color      Score      Shape Size Flavor Imprint Code Contains

Packaging # NDC Package Description Multilevel Packaging 1 55390-357-03 1 VIAL In 1 BOX contains a VIAL 1 3 mL In 1 VIAL This package is contained within the BOX (55390-357-03)

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
NDA	NDA020793	11/04/2008

Cafcit  caffeine citrate  solution

Product Information Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 55390-358 Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength CAFFEINE CITRATE (CAFFEINE) CAFFEINE CITRATE 20 mg  in 1 mL

Inactive Ingredients Ingredient Name Strength CITRIC ACID MONOHYDRATE 5 mg  in 1 mL SODIUM CITRATE 8.3 mg  in 1 mL WATER

Product Characteristics Color      Score      Shape Size Flavor Imprint Code Contains

Packaging # NDC Package Description Multilevel Packaging 1 55390-358-03 10 VIAL In 1 BOX contains a VIAL 1 3 mL In 1 VIAL This package is contained within the BOX (55390-358-03)

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
NDA	NDA020793	11/04/2008

Labeler - Bedford Laboratories (884528407)

Revised: 06/2010Bedford Laboratories

More Cafcit resources

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

• Cafcit Concise Consumer Information (Cerner Multum)


• Cafcit Solution MedFacts Consumer Leaflet (Wolters Kluwer)


• Cafcit Advanced Consumer (Micromedex) - Includes Dosage Information


• Caffeine Professional Patient Advice (Wolters Kluwer)


• Caffeine MedFacts Consumer Leaflet (Wolters Kluwer)


• Caffeine; Caffeine and Sodium Benzoate Injection; Caffeine Citrate Monograph (AHFS DI)

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  Inventor(s): Dawson; Chandler R. & Bowman; Lyle M.
  Assignee(s): InSite Vision, Incorporated
  The topical application of an azalide antibiotic such as azithromycin to the eye is useful in treating or preventing ocular infections. In one embodiment, the azalide antibiotic is supplied to the eye in a depot for sustained release. A more convenient dosing regimen can also be provided by the use of an appropriate depot. Furthermore, a composition containing a combination of medicaments is also provided.
  
  Patent expiration dates:
  
  
  • March 31, 2019
    
    ✓ 
    Patent use: METHOD OF COMBATING BACTERIA IN A PATIENT
  
  



• 
  Topical treatment or prevention of ocular infections
  Patent 6,569,443
  Issued: May 27, 2003
  Inventor(s): Chandler R.; Dawson & Lyle M.; Bowman
  Assignee(s): Insite Vision, Inc.
  The topical application of an azalide antibiotic such as azithromycin to the eye is useful in treating or preventing ocular infections. In one embodiment, the azalide antibiotic is supplied to the eye in a depot for sustained release. A more convenient dosing regimen can also be provided by the use of an appropriate depot. Furthermore, a composition containing a combination of medicaments is also provided.
  
  Patent expiration dates:
  
  
  • March 31, 2019
    
    ✓ 
    Patent use: METHOD OF COMBATING BACTERIA IN A PATIENT
    ✓ 
    Drug product
  
  



• 
  Method of treating eye infections with azithromycin
  Patent 6,861,411
  Issued: March 1, 2005
  Inventor(s): Ahmed; Imran
  Assignee(s): Pfizer, Inc.
  The invention features methods and compositions for treating ocular infections. The method comprises topically administering to an eye of an animal in need of such treatment an ocular infection-treating amount of azithromycin.
  
  Patent expiration dates:
  
  
  • November 25, 2018
    
    ✓ 
    Patent use: METHOD OF COMBATING BACTERIA IN A PATIENT
  
  



• 
  Topical treatment for prevention of ocular infections
  Patent 7,056,893
  Issued: June 6, 2006
  Inventor(s): Roy; Samir & Bowman; Lyle M.
  Assignee(s): Insite Vision, Inc.
  Azalide antibiotics such as azithromycin are useful in the treatment and prevention of infections by bacteria and other parasites. Stabilized aqueous compositions containing azithromycin suitable for administration without reconstitution are provided for. Also provided for are aqueous formulations suitable for ocular administration in a employing a convenient dosing formulation suitable for administration in depot formats.
  
  Patent expiration dates:
  
  
  • March 31, 2019
    
    ✓ 
    Patent use: METHOD OF COMBATING BACTERIA IN A PATIENT
    ✓ 
    Drug product
  
  

See also...

• AzaSite Consumer Information (Drugs.com)
• Azasite Drops Consumer Information (Wolters Kluwer)
• AzaSite Consumer Information (Cerner Multum)
• AzaSite Advanced Consumer Information (Micromedex)
• Azithromycin Drops Consumer Information (Wolters Kluwer)
• Azithromycin ophthalmic Consumer Information (Cerner Multum)
• Azithromycin Ophthalmic Advanced Consumer Information (Micromedex)

Nicorette 15mg Inhalator

1. Name Of The Medicinal Product

Nicorette® 15mg Inhalator / Boots NicAssist 15 mg Inhalator.

2. Qualitative And Quantitative Composition

Nicotine 15mg per cartridge.

For a full list of excipients see section 6.1

3. Pharmaceutical Form

Inhalation cartridge for oromucosal use.

A white to slightly coloured porous plug in a sealed, transparent plastic tube.

4. Clinical Particulars

4.1 Therapeutic Indications

Nicorette Inhalator relieves and/or prevents craving and nicotine withdrawal symptoms associated with tobacco dependence. It is indicated to aid smokers wishing to quit or reduce prior to quitting, to assist smokers who are unwilling or unable to smoke, and as a safer alternative to smoking for smokers and those around them.

Nicorette Inhalator is indicated in pregnant and lactating women making a quit attempt.

4.2 Posology And Method Of Administration

Adults and Children over 12 years of age

Nicorette Inhalator should be used whenever the urge to smoke is felt or to prevent cravings in situations where these are likely to occur.

Smokers willing or able to stop smoking immediately should initially replace all their cigarettes with the Inhalator and as soon as they are able, reduce the number of cartridges used until they have stopped completely.

Smokers aiming to reduce cigarettes should use the Inhalator, as needed, between smoking episodes to prolong smoke-free intervals and with the intention to reduce smoking as much as possible.

As soon as they are ready smokers should aim to quit smoking completely.

Maximum daily dose: 6 cartridges.

When making a quit attempt behavioural therapy, advice and support will normally improve the success rate. Those who have quit smoking, but are having difficulty discontinuing their Inhalator are recommended to contact their pharmacist or doctor for advice.

Each cartridge can be used for approximately eight 5-minute sessions, with each cartridge lasting approximately 40 minutes of intense use. The more the subject is able to use the inhalator, the easier it will be to achieve maximum reduction of cigarettes and/or quit smoking completely.

Method of administration

The cartridge is inserted into the mouthpiece according to the instructions.

When a patient draws air into the mouth through the mouthpiece, nicotine is vaporised and absorbed by the buccal mucosa. Minimal nicotine reaches the lungs. The amount of nicotine from a puff is less than that from a cigarette. To compensate for less nicotine delivery from a puff it is necessary to inhale more often than when smoking a cigarette.

The number of cartridges, frequency, puffing/inhalation time and technique does vary between individuals.

The actual time that the cartridge is active depends on the intensity of use. After about 40 minutes of intense use the maximal dose is achieved and it is about then that the nicotine amounts released from the cartridge begin to fall away, such that the cartridge is rejected by the user.

4.3 Contraindications

Hypersensitivity to any component of the inhalator.

Nicorette Inhalator is contraindicated in children under the age of 12 years.

4.4 Special Warnings And Precautions For Use

Any risks that may be associated with NRT are substantially outweighed by the well established dangers of continued smoking.

Underlying cardiovascular disease: In stable cardiovascular disease Nicorette Inhalator presents a lesser hazard than continuing to smoke. However dependent smokers currently hospitalised as a result of myocardial infarction, severe dysrhythmia or CVA and who are considered to be haemodynamically unstable should be encouraged to stop smoking with non-pharmacological interventions. If this fails, Nicorette Inhalator may be considered, but as data on safety in this patient group are limited, initiation should only be under medical supervision.

Diabetes mellitus: Patients with diabetes mellitus should be advised to monitor their blood sugar levels more closely than usual when NRT is initiated as catecholamines released by nicotine can affect carbohydrate metabolism.

GI disease: Swallowed nicotine may exacerbate symptoms in patients suffering from oesophagitis, gastritis or peptic ulcers and oral NRT preparations should be used with caution in these conditions. Ulcerative stomatitis has been reported.

Renal or hepatic impairment: Nicorette Inhalator should be used with caution in patients with moderate to severe hepatic impairment and/or severe renal impairment as the clearance of nicotine or its metabolites may be decreased with the potential for increased adverse effects.

Danger in small children: Doses of nicotine tolerated by adult and adolescent smokers can produce severe toxicity in small children that may be fatal. Products containing nicotine should not be left where they may be misused, handled or ingested by children.

Phaeochromocytoma and uncontrolled hyperthyroidism: As nicotine causes release of catecholamines, Nicorette Inhalator should be used with caution in patients with uncontrolled hyperthyroidism or phaeochromocytoma.

Transferred dependence: Transferred dependence is rare and is both less harmful and easier to break than smoking dependence.

Stopping smoking: Polycyclic aromatic hydrocarbons in tobacco smoke induce the metabolism of drugs metabolised by CYP 1A2 (and possibly by CYP 1A1). When a smoker stops smoking, this may result in slower metabolism and a consequent rise in blood levels of such drugs. This is of potential clinical importance for products with a narrow therapeutic window, e.g. theophylline, clozapine and ropinirole.

Lung Disease: Patients with obstructive lung disease may find use of the Inhalator difficult. Nicotine Gum, Patch, Nasal Spray or Sublingual tablet may be preferred in such cases. Nicorette Inhalator should be used with caution in patients with chronic throat disease and bronchospastic disease.

Allergic reactions: Susceptibility to angioedema and urticaria.

Potential choking hazard: This product contains some small parts. Any unused cartridges should remain in the cartridge tray to minimise the risk of swallowing.

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

No clinically relevant interactions between nicotine replacement therapy and other drugs have definitely been established. However nicotine may possibly enhance the haemodynamic effects of adenosine i.e. increase in blood pressure and heart rate and also increase pain response (angina-pectoris type chest pain) provoked by adenosine administration.

4.6 Pregnancy And Lactation

Pregnancy

Stopping smoking is the single most effective intervention for improving the health of both the pregnant smoker and her baby, and the earlier abstinence is achieved the better. Ideally smoking cessation during pregnancy should be achieved without NRT. However, if the mother cannot (or is considered unlikely to) quit without pharmacological support, NRT may be used as the risk to the foetus is lower than that expected with smoking tobacco. Stopping completely is by far the best option but if this is not achievable Nicorette Inhalator may be used in pregnancy as a safer alternative to smoking. Because of the potential for nicotine-free periods, intermittent dose forms are preferable, but patches may be necessary if there is significant nausea and/or vomiting. If patches are used they should, if possible, be removed at night when the foetus would not normally be exposed to nicotine.

Lactation

The relatively small amounts of nicotine found in breast milk during NRT use are less hazardous to the infant than second-hand smoke. Intermittent dose forms would minimize the amount of nicotine in breast milk and permit feeding when levels were at their lowest.

4.7 Effects On Ability To Drive And Use Machines

This medicinal product has no or negligible influence on the ability to drive and use machines.

4.8 Undesirable Effects

Some symptoms may be related to nicotine withdrawal associated with stopping smoking. These can include; irritability/aggression, dysphoria/depressed mood, anxiety, restlessness, poor concentration, increased appetite/weight gain, urges to smoke (cravings), night-time awakenings/sleep disturbance and decreased heart rate.

Increased frequency of aphthous ulcer may occur after abstinence from smoking. The causality is unclear.

Nicorette Inhalator may cause adverse reactions similar to those associated with nicotine given by other means, including smoking, and these are mainly dose-dependent. At recommended doses Nicorette Inhalator has not been found to cause any serious adverse effects. Excessive use of Nicorette Inhalator by those who have not been in the habit of inhaling tobacco smoke could possibly lead to nausea, faintness or headaches.

Most of the undesirable effects reported by the patient occur during the first weeks after starting treatment. About 40% of users experience mild local reactions such as cough and irritation in the mouth and throat.

Reported adverse events associated with Nicorette Inhalator include:

Body System	Incidence*	Reported adverse event
Nervous system disorders:	Very common:	Headache
	Common:	Dizziness
Cardiac disorders:	Uncommon:	Palpitations
	Very rare:	Reversible atrial fibrillation
Respiratory, thoracic and mediastinal disorders:	Very common:	Coughing
Gastrointestinal disorders:	Common:	Gastrointestinal discomfort, hiccups, nausea, vomiting
General disorders and administration site disorders:	Very common:	Irritation in mouth and throat
	Common:	Nasal congestion

* Very common (>1/10); common (>1/100, <1/10); uncommon (>1/1 000, <1/100); rare (>1/10 000, <1/1 000); very rare (<1/10 000), including isolated reports.

4.9 Overdose

Symptoms: The minimum lethal dose of nicotine in a non-tolerant man has been estimated to be 40 to 60mg. Symptoms of acute nicotine poisoning include nausea, salivation, abdominal pain, diarrhoea, sweating headache, dizziness, disturbed hearing and marked weakness. In extreme cases, these symptoms may be followed by hypotension, rapid or weak or irregular pulse, breathing difficulties, prostration, circulatory collapse and terminal convulsions.

Management of an overdose: All nicotine in-take should stop immediately and the patient should be treated symptomatically. Artificial respiration should be instituted if necessary. Activated charcoal reduces the gastro-intestinal absorption of nicotine

5. Pharmacological Properties

5.1 Pharmacodynamic Properties

Pharmacotherapeutic Group: Drug for treatment of addiction.

ATC Code: N07B A01

Nicorette Inhalator facilitates uptake of nicotine through the buccal mucosa into the venous circulation. The amount taken up alleviates the craving symptoms caused by the absence of nicotine from smoking.

Increased appetite is a recognised symptom of nicotine withdrawal and post-cessation weight gain is common. Clinical trials have demonstrated that Nicotine Replacement Therapy can help control weight following a quit attempt.

5.2 Pharmacokinetic Properties

The following information is based on data derived from Nicorette 10mg Inhalator:

Nicotine given i.v. has a volume of the distribution of 2 or 3 l/kg with a half life of 1-2 hours. Average plasma clearance is about 1-2 l/min mainly in the liver. More than 20 metabolites are known, all less active than nicotine: cotinine, with a half life of 15-20 hours and concentrations ten times that of nicotine is the main one.

Plasma binding of nicotine below 5% means significant displacement of drugs or nicotine is unlikely. Nicotine is excreted in the urine principally as cotinine (15%), 3-hydroxycotinine (45%), nicotine (10%).

Most inhaled nicotine is absorbed via the buccal mucosa. Forced rapid inhalation over 20 minutes, results in a wide range of nicotine doses (1.3-6.2 mg). On average 2 mg of nicotine is released during 20 minutes of intensive use. Uptake is slow and free of the peaks resultant from cigarette smoking. In normal use, plasma levels of 6-8ng/ml nicotine are obtained – about one third that from smoking, which is equivalent to an hourly 2mg nicotine chewing gum.

When used like a cigarette the inhalator on average delivers 1mg in 80 puffs (e.g. 8 puffs per minute for 10 minutes). When used in this way this results in, a degree of nicotine substitution of about 50% compared to hourly smoking. Peak plasma levels occur within 15 minutes after the end of inhalation. Forced rapid inhalation for 20 minutes per hour for 12 hours achieved steady state plasma levels of 20-25ng/ml.

Ambient temperature affects volatilisation of nicotine, the biologically available dose rising by 35% for each 10°C above 20°C. Use below 15°C is not recommended.

Because the pattern of use if decided by the patient up to a limit of 6 cartridges per day to relieve craving, therapeutic levels of nicotine are individual, dictated by the level of dependence.

5.3 Preclinical Safety Data

None stated.

6. Pharmaceutical Particulars

6.1 List Of Excipients

Levomenthol

Porous plug of polyethylene

6.2 Incompatibilities

Not applicable

6.3 Shelf Life

Two years.

Once inserted into the mouthpiece the cartridge should be disposed of within 48 hours even if it has not been used.

6.4 Special Precautions For Storage

Store below 25°C.

This product works best at room temperature. In cold conditions (below 15°C) the nicotine evaporates less readily and it will be necessary to inhale more frequently, whilst in warm conditions (above 30°C) nicotine will evaporate more readily and inhalation should be less frequent to avoid overdose.

6.5 Nature And Contents Of Container

Polypropylene mouthpiece with acrylonitrile / methacrylate copolymer cartridges containing polyethylene porous plugs with polyester / aluminium foil seals.

The cartridges are provided in a PVC tray which is sealed with aluminium foil.

Pack sizes:

4 cartridges with 1 inhalator mouthpiece

20 cartridges with 1 inhalator mouthpiece

36 cartridges with 1 inhalator mouthpiece

Not all pack sizes may be marketed.

6.6 Special Precautions For Disposal And Other Handling

Potential choking hazard: This product contains some small parts. Any unused cartridges should remain in the cartridge tray to minimise the risk of swallowing.

Because of residual nicotine, used cartridges may be a hazard to children, animals and fish and so should never be thrown away or left lying around. They should be kept in the case and disposed of with household rubbish.

7. Marketing Authorisation Holder

McNeil Products Limited

Foundation Park

Roxborough Way

Maidenhead

Berkshire

SL6 3UG

UK

8. Marketing Authorisation Number(S)

PL 15513/0358

9. Date Of First Authorisation/Renewal Of The Authorisation

03 June 2011

10. Date Of Revision Of The Text

19 July 2011

Unizox

Unizox may be available in the countries listed below.

Ingredient matches for Unizox

Ceftizoxime

Ceftizoxime sodium salt (a derivative of Ceftizoxime) is reported as an ingredient of Unizox in the following countries:

• Philippines

International Drug Name Search

cocaine hydrochloride Topical

koe-KANE

Topical route(Solution)

Not for injection or ophthalmic use .

Available Dosage Forms:

• Solution


• Paste

Therapeutic Class: Anesthetic, Local

Chemical Class: Amino Ester

Uses For cocaine hydrochloride

Cocaine is a local anesthetic. It is applied to certain areas of the body (for example, the nose, mouth, or throat) to cause loss of feeling or numbness. This allows certain kinds of procedures or surgery to be done without causing pain.

Cocaine can cause psychological dependence (a strong desire to continue using the medicine because of the "high" feeling it produces). This may lead to cocaine abuse (more frequent use and/or use of larger amounts of cocaine) and to an increased chance of serious side effects. Cocaine abuse has caused death from heart or breathing failure.

Use of cocaine as a local anesthetic for an examination or surgery is not likely to cause psychological dependence or other serious side effects. However, if cocaine is absorbed into the body too quickly, serious side effects can occur. Also, some people are especially sensitive to the effects of cocaine. Unwanted effects may occur in these people even with small amounts of the medicine. Before receiving cocaine as a local anesthetic, you should discuss its use with your doctor.

Cocaine is applied only by or under the immediate supervision of your doctor.

Before Using cocaine hydrochloride

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For cocaine hydrochloride, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to cocaine hydrochloride or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Cocaine can cause serious side effects in any patient. Therefore, it is especially important that you discuss with the child's doctor the good that cocaine hydrochloride may do as well as the risks of using it.

Geriatric

Side effects, including dizziness, lightheadedness, or fast or irregular heartbeats, may be more likely to occur in elderly patients. The elderly are usually more sensitive than younger adults to the effects of cocaine.

Pregnancy

	Pregnancy Category	Explanation
All Trimesters	C	Animal studies have shown an adverse effect and there are no adequate studies in pregnant women OR no animal studies have been conducted and there are no adequate studies in pregnant women.

Breast Feeding

Studies in women breastfeeding have demonstrated harmful infant effects. An alternative to this medication should be prescribed or you should stop breastfeeding while using cocaine hydrochloride.

Interactions with Medicines

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are receiving cocaine hydrochloride, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using cocaine hydrochloride with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.

• Dihydroergotamine


• Phenelzine

Using cocaine hydrochloride with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Hyaluronidase


• St John's Wort

Using cocaine hydrochloride with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Cannabis

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using cocaine hydrochloride with any of the following may cause an increased risk of certain side effects but may be unavoidable in some cases. If used together, your doctor may change the dose or how often you use cocaine hydrochloride, or give you special instructions about the use of food, alcohol, or tobacco.

• Ethanol

Other Medical Problems

The presence of other medical problems may affect the use of cocaine hydrochloride. Make sure you tell your doctor if you have any other medical problems, especially:

• Cancer or


• Chest pain, or history of, or


• Convulsions (seizures), history of, or


• Fast or irregular heartbeat or


• Heart or blood vessel disease or


• High blood pressure or


• Liver disease or


• Myocardial infarction (heart attack), history of, or


• Overactive thyroid—The chance of serious side effects may be increased.

• Tourette's syndrome—May make this condition worse.

Proper Use of cocaine hydrochloride

Your doctor or nurse will apply the smallest amount of medicine that will produce the needed effect before the procedure.

Precautions While Using cocaine hydrochloride

Cocaine and some of its metabolites (substances to which cocaine is broken down in the body) will appear in your blood and urine for several days after you receive the medicine. Tests for possible drug use will then be "positive" for cocaine. If you must have such a test within 5 days or so after receiving cocaine, be sure to tell the person in charge that you have recently received cocaine for medical reasons. It may be helpful to have written information from your doctor stating why the medicine was used, the date on which you received it, and the amount you received.

cocaine hydrochloride Side Effects

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor or nurse immediately if any of the following side effects occur:

Less common or Rare

• Abdominal or stomach pain


• chills


• confusion


• dizziness or lightheadedness


• excitement, nervousness, restlessness, or any mood or mental changes


• fast or irregular heartbeat


• general feeling of discomfort or illness


• hallucinations or seeing, hearing, or feeling things that are not there


• headache (sudden)


• increased sweating


• nausea

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common

• Loss of sense of taste or smell (after use in the nose or mouth)

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

See also: cocaine hydrochloride Topical side effects (in more detail)

The information contained in the Thomson Reuters Micromedex products as delivered by Drugs.com is intended as an educational aid only. It is not intended as medical advice for individual conditions or treatment. It is not a substitute for a medical exam, nor does it replace the need for services provided by medical professionals. Talk to your doctor, nurse or pharmacist before taking any prescription or over the counter drugs (including any herbal medicines or supplements) or following any treatment or regimen. Only your doctor, nurse, or pharmacist can provide you with advice on what is safe and effective for you.

The use of the Thomson Reuters Healthcare products is at your sole risk. These products are provided "AS IS" and "as available" for use, without warranties of any kind, either express or implied. Thomson Reuters Healthcare and Drugs.com make no representation or warranty as to the accuracy, reliability, timeliness, usefulness or completeness of any of the information contained in the products. Additionally, THOMSON REUTERS HEALTHCARE MAKES NO REPRESENTATION OR WARRANTIES AS TO THE OPINIONS OR OTHER SERVICE OR DATA YOU MAY ACCESS, DOWNLOAD OR USE AS A RESULT OF USE OF THE THOMSON REUTERS HEALTHCARE PRODUCTS. ALL IMPLIED WARRANTIES OF MERCHANTABILITY AND FITNESS FOR A PARTICULAR PURPOSE OR USE ARE HEREBY EXCLUDED. Thomson Reuters Healthcare does not assume any responsibility or risk for your use of the Thomson Reuters Healthcare products.

More cocaine hydrochloride Topical resources

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

Compare cocaine hydrochloride Topical with other medications

• Local Anesthesia

Kromicin

Kromicin may be available in the countries listed below.

Ingredient matches for Kromicin

Azithromycin

Azithromycin dihydrate (a derivative of Azithromycin) is reported as an ingredient of Kromicin in the following countries:

• Colombia

International Drug Name Search

Monoket retard

Monoket retard may be available in the countries listed below.

Ingredient matches for Monoket retard

Isosorbide Mononitrate

Isosorbide Mononitrate is reported as an ingredient of Monoket retard in the following countries:

• Austria

International Drug Name Search

Procaterolo

Procaterolo may be available in the countries listed below.

Ingredient matches for Procaterolo

Procaterol

Procaterolo (DCIT) is also known as Procaterol (Rec.INN)

International Drug Name Search

Glossary

DCIT	Denominazione Comune Italiana
Rec.INN	Recommended International Nonproprietary Name (World Health Organization)

Click for further information on drug naming conventions and International Nonproprietary Names.

Eulexin

In the US, Eulexin (flutamide systemic) is a member of the following drug classes: antiandrogens, hormones/antineoplastics and is used to treat Hirsutism and Prostate Cancer.

US matches:

• Eulexin

Ingredient matches for Eulexin

Flutamide

Flutamide is reported as an ingredient of Eulexin in the following countries:

• Australia


• Bahrain


• Belgium


• Brazil


• Colombia


• Denmark


• Iceland


• Israel


• Italy


• Kenya


• Luxembourg


• Norway


• Oman


• Portugal


• South Africa


• Spain


• Sweden


• Turkey


• United States


• Venezuela

International Drug Name Search

Procaterol Hydrochloride

Procaterol Hydrochloride may be available in the countries listed below.

Ingredient matches for Procaterol Hydrochloride

Procaterol

Procaterol Hydrochloride (BANM, JAN, USAN) is also known as Procaterol (Rec.INN)

International Drug Name Search

Glossary

BANM	British Approved Name (Modified)
JAN	Japanese Accepted Name
Rec.INN	Recommended International Nonproprietary Name (World Health Organization)
USAN	United States Adopted Name

Click for further information on drug naming conventions and International Nonproprietary Names.

Seba-Clear Topical

Generic Name: salicylic acid (Topical route)

sal-i-SIL-ik AS-id

Commonly used brand name(s)

In the U.S.

• Akurza


• Aliclen


• Avosil


• Betasal


• Compound W


• Corn Removing


• Dermarest Psoriasis


• DHS Sal


• Drytex


• Duofilm


• Duoplant


• Durasal


• Freezone


• Fung-O


• Gets-It Corn/Callus Remover


• Gordofilm


• Hydrisalic


• Ionil


• Ionil Plus


• Keralyt


• Keralyt Scalp


• Lupicare


• Mediplast


• Mg217 Sal-Acid


• Mosco Corn & Callus Remover


• Neutrogena


• Occlusal-HP


• Off-Ezy


• Oxy Balance


• P & S


• Palmer's Skin Success Acne Cleanser


• Propa pH


• Salac


• Sal-Acid Plaster


• Salactic Film


• Salex


• Salitop


• Salkera


• Sal-Plant Gel


• Salvax


• Seba-Clear


• Stri-Dex


• Thera-Sal


• Therasoft Anti-Acne


• Tinamed


• Ti-Seb


• Virasal


• Wart-Off Maximum Strength


• Zapzyt

In Canada

• Acnex


• Acnomel Acne Mask


• Clear Away Wart Removal System


• Compound W One-Step Wart Remover


• Compound W Plus


• Dr. Scholl's Clear Away One Step Plantar Wart Remover


• Dr. Scholl's Cushlin Ultra Slim Callus Removers


• Dr. Scholl's Cushlin Ultra Slim Corn Removers


• Duoforte 27


• Freezone - One Step Callus Remover Pad


• Freezone - One Step Corn Remover Pad

Available Dosage Forms:

• Soap


• Lotion


• Liquid


• Foam


• Ointment


• Gel/Jelly


• Solution


• Cream


• Pad


• Paste


• Shampoo


• Dressing


• Stick

Therapeutic Class: Antiacne

Pharmacologic Class: NSAID

Chemical Class: Salicylate, Non-Aspirin

Uses For Seba-Clear

Salicylic acid is used to treat many skin disorders, such as acne, dandruff, psoriasis, seborrheic dermatitis of the skin and scalp, calluses, corns, common warts, and plantar warts, depending on the dosage form and strength of the preparation.

Some of these preparations are available only with your doctor's prescription.

Before Using Seba-Clear

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Young children may be at increased risk of unwanted effects because of increased absorption of salicylic acid through the skin. Also, young children may be more likely to get skin irritation from salicylic acid. Salicylic acid should not be applied to large areas of the body, used for long periods of time, or used under occlusive dressing (air-tight covering, such as kitchen plastic wrap) in infants and children. Salicylic acid should not be used in children younger than 2 years of age.

Geriatric

Elderly people are more likely to have age-related blood vessel disease. This may increase the chance of problems during treatment with this medicine.

Breast Feeding

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Interactions with Medicines

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Abciximab


• Argatroban


• Bivalirudin


• Cilostazol


• Citalopram


• Clovoxamine


• Dabigatran Etexilate


• Dipyridamole


• Escitalopram


• Femoxetine


• Flesinoxan


• Fluoxetine


• Fluvoxamine


• Fondaparinux


• Heparin


• Lepirudin


• Nefazodone


• Paroxetine


• Protein C


• Rivaroxaban


• Sertraline


• Sibutramine


• Ticlopidine


• Tirofiban


• Vilazodone


• Zimeldine

Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Acenocoumarol


• Anisindione


• Ardeparin


• Azilsartan Medoxomil


• Azosemide


• Bemetizide


• Bendroflumethiazide


• Benzthiazide


• Bumetanide


• Buthiazide


• Candesartan Cilexetil


• Certoparin


• Chlorothiazide


• Chlorthalidone


• Clopamide


• Cyclopenthiazide


• Dalteparin


• Danaparoid


• Dicumarol


• Enoxaparin


• Eprosartan


• Ethacrynic Acid


• Furosemide


• Hydrochlorothiazide


• Hydroflumethiazide


• Indapamide


• Irbesartan


• Losartan


• Methyclothiazide


• Metolazone


• Nadroparin


• Olmesartan Medoxomil


• Parnaparin


• Phenindione


• Phenprocoumon


• Piretanide


• Polythiazide


• Probenecid


• Reviparin


• Tamarind


• Tasosartan


• Telmisartan


• Tinzaparin


• Torsemide


• Trichlormethiazide


• Valsartan


• Warfarin


• Xipamide

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other Medical Problems

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

• Blood vessel disease

• Diabetes mellitus (sugar diabetes)—Use of this medicine may cause severe redness or ulceration, especially on the hands or feet

• Inflammation, irritation, or infection of the skin—Use of this medicine may cause severe irritation if applied to inflamed, irritated, or infected area of the skin

• Influenza (flu) or


• Varicella (chicken pox)—This medicine should not be used in children and teenagers with the flu or chicken pox. There is a risk of Reye's syndrome.

• Kidney disease or


• Liver disease—Using this medicine for a long time over large areas could result in unwanted effects

Proper Use of salicylic acid

This section provides information on the proper use of a number of products that contain salicylic acid. It may not be specific to Seba-Clear. Please read with care.

It is very important that you use this medicine only as directed. Do not use more of it, do not use it more often, and do not use it for a longer time than recommended on the label, unless otherwise directed by your doctor. To do so may increase the chance of absorption through the skin and the chance of salicylic acid poisoning.

If your doctor has ordered an occlusive dressing (airtight covering, such as kitchen plastic wrap) to be applied over this medicine, make sure you know how to apply it. Since an occlusive dressing will increase the amount of medicine absorbed through your skin and the possibility of salicylic acid poisoning, use it only as directed. If you have any questions about this, check with your doctor.

Keep this medicine away from the eyes and other mucous membranes, such as the mouth and inside of the nose. If you should accidentally get some in your eyes or on other mucous membranes, immediately flush them with water for 15 minutes.

To use the cream, lotion, or ointment form of salicylic acid:

• Apply enough medicine to cover the affected area, and rub in gently.

To use the gel form of salicylic acid:

• Before using salicylic acid gel, apply wet packs to the affected areas for at least 5 minutes. If you have any questions about this, check with your health care professional.


• Apply enough gel to cover the affected areas, and rub in gently.

To use the pad form of salicylic acid:

• Wipe the pad over the affected areas.


• Do not rinse off medicine after treatment.

To use the plaster form of salicylic acid for warts, corns, or calluses:

• This medicine comes with patient instructions. Read them carefully before using.


• Do not use this medicine on irritated skin or on any area that is infected or reddened. Also, do not use this medicine if you are a diabetic or if you have poor blood circulation.


• Do not use this medicine on warts with hair growing from them or on warts on the face, in or on the genital (sex) organs, or inside the nose or mouth. Also do not use on moles or birthmarks. To do so may cause severe irritation.


• Wash the area to be treated and dry thoroughly. Warts may be soaked in warm water for 5 minutes before drying.


• Cut the plaster to fit the wart, corn, or callus and apply.


• For corns and calluses:
  
  • Repeat every 48 hours as needed for up to 14 days, or as directed by your doctor, until the corn or callus is removed.
  
  
  • Corns or calluses may be soaked in warm water for 5 minutes to help in their removal.
  
  


• For warts:
  
  • Depending on the product, either:
    
    • Apply plaster and repeat every 48 hours as needed, or
      
      • Apply plaster at bedtime, leave in place for at least 8 hours, remove plaster in the morning, and repeat every 24 hours as needed.
      
      
    
    
  
  
  • Repeat for up to 12 weeks as needed, or as directed by your doctor, until wart is removed.
  
  


• If discomfort gets worse during treatment or continues after treatment, or if the wart spreads, check with your doctor.

To use the shampoo form of salicylic acid:

• Before applying this medicine, wet the hair and scalp with lukewarm water. Apply enough medicine to work up a lather and rub well into the scalp for 2 or 3 minutes, then rinse. Apply the medicine again and rinse thoroughly.

To use the soap form of salicylic acid:

• Work up a lather with the soap, using hot water, and scrub the entire affected area with a washcloth or facial sponge or mitt.


• If you are to use this soap in a foot bath, work up rich suds in hot water and soak the feet for 10 to 15 minutes. Then pat dry without rinsing.

To use the topical solution form of salicylic acid for acne:

• Wet a cotton ball or pad with the topical solution and wipe the affected areas.


• Do not rinse off medicine after treatment.

To use the topical solution form of salicylic acid for warts, corns, or calluses:

• This medicine comes with patient instructions. Read them carefully before using.


• This medicine is flammable. Do not use it near heat or open flame or while smoking.


• Do not use this medicine on irritated skin or on any area that is infected or reddened. Also, do not use this medicine if you are a diabetic or if you have poor blood circulation.


• Do not use this medicine on warts with hair growing from them or on warts on the face, in or on the genital (sex) organs, or inside the nose or mouth. Also do not use on moles or birthmarks. To do so may cause severe irritation.


• Avoid breathing in the vapors from the medicine.


• Wash the area to be treated and dry thoroughly. Warts may be soaked in warm water for 5 minutes before drying.


• Apply the medicine one drop at a time to completely cover each wart, corn, or callus. Let dry.


• For warts—Repeat one or two times a day as needed for up to 12 weeks, or as directed by your doctor, until wart is removed.


• For corns and calluses—Repeat one or two times a day as needed for up to 14 days, or as directed by your doctor, until the corn or callus is removed.


• Corns and calluses may be soaked in warm water for 5 minutes to help in their removal.


• If discomfort gets worse during treatment or continues after treatment, or if the wart spreads, check with your doctor.

Unless your hands are being treated, wash them immediately after applying this medicine to remove any medicine that may be on them.

Dosing

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

• For cream dosage form:
  
  • For corns and calluses:
    
    • Adults and children—Use the 2 to 10% cream as needed. Use the 25 to 60% cream one time every three to five days.
    
    
  
  


• For gel dosage form:
  
  • For acne:
    
    • Adults and children—Use the 0.5 to 5% gel one time a day.
    
    
  
  
  • For psoriasis:
    
    • Adults and children—Use the 5% gel one time a day.
    
    
  
  
  • For common warts:
    
    • Adults and children—Use the 5 to 26% gel one time a day.
    
    
  
  


• For lotion dosage form:
  
  • For acne:
    
    • Adults and children—Use the 1 to 2% lotion one to three times a day.
    
    
  
  
  • For dandruff and antiseborrhic dermatitis of the scalp:
    
    • Adults and children—Use the 1.8 to 2% lotion on the scalp one or two times a day.
    
    
  
  


• For ointment dosage form:
  
  • For acne:
    
    • Adults and children—Use the 3 to 6% ointment as needed.
    
    
  
  
  • For psoriasis and seborrheic dermatitis:
    
    • Adults and children—Use the 3 to 10% ointment as needed.
    
    
  
  
  • For common warts:
    
    • Adults and children—Use the 3 to 10% ointment as needed. Use the 25 to 60% ointment one time every three to five days.
    
    
  
  


• For pads dosage form:
  
  • For acne:
    
    • Adults and children—Use one to three times a day.
    
    
  
  


• For plaster dosage form:
  
  • For corns, calluses, common warts, or plantar warts:
    
    • Adults and children—Use one time a day or one time every other day.
    
    
  
  


• For shampoo dosage form:
  
  • For dandruff or seborrheic dermatitis of the scalp:
    
    • Adults and children—Use on the scalp one or two times a week.
    
    
  
  


• For soap dosage form:
  
  • For acne:
    
    • Adults and children—Use as needed.
    
    
  
  


• For topical solution dosage form:
  
  • For acne:
    
    • Adults and children—Use the 0.5 to 2% topical solution one to three times a day.
    
    
  
  
  • For common warts and plantar warts:
    
    • Adults and children—Use the 5 to 27% topical solution one or two times a day.
    
    
  
  
  • For corns and calluses:
    
    • Adults and children—Use the 12 to 27% topical solution one or two times a day.
    
    
  
  

Missed Dose

If you miss a dose of this medicine, apply it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule.

Storage

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Precautions While Using Seba-Clear

When using salicylic acid, do not use any of the following preparations on the same affected area as this medicine, unless otherwise directed by your doctor:

• Abrasive soaps or cleansers


• Alcohol-containing preparations


• Any other topical acne preparation or preparation containing a peeling agent (for example, benzoyl peroxide, resorcinol, sulfur, or tretinoin [vitamin A acid])


• Cosmetics or soaps that dry the skin


• Medicated cosmetics


• Other topical medicine for the skin

To use any of the above preparations on the same affected area as salicylic acid may cause severe irritation of the skin.

Check with your doctor right away if you have nausea, vomiting, dizziness, loss of hearing, tinnitus, lethargy hyperpnea, diarrhea, and psychic disturbances. These could be symptoms of a serious condition called salicylate toxicity, especially in children under 12 years of age and patients with kidney or liver problems.

Seba-Clear Side Effects

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor as soon as possible if any of the following side effects occur:

Less common or rare

• Skin irritation not present before use of this medicine (moderate or severe)

Frequency not known

• Dryness and peeling of skin


• flushing


• redness of skin


• unusually warm skin

Symptoms of salicylic acid poisoning

• Confusion


• diarrhea


• dizziness


• fast or deep breathing


• headache (severe or continuing)


• hearing loss


• lightheadedness


• nausea


• rapid breathing


• ringing or buzzing in ears (continuing)


• severe drowsiness


• stomach pain


• vomiting

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common

• Skin irritation not present before use of this medicine (mild)


• stinging

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

See also: Seba-Clear Topical side effects (in more detail)

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More Seba-Clear Topical resources

• Seba-Clear Topical Side Effects (in more detail)
• Seba-Clear Topical Use in Pregnancy & Breastfeeding
• Seba-Clear Topical Drug Interactions
• Seba-Clear Topical Support Group
• 1 Review for Seba-Clear Topical - Add your own review/rating

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