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Monday, November 14, 2016

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

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)

Compare Cafcit with other medications

Caffeine/Ergotamine

Pronunciation: ka-FEEN/er-GOT-a-meen
Generic Name: Caffeine/Ergotamine
Brand Name: Cafergot

Serious and sometimes life-threatening decreases in the blood supply to the extremities (eg, hands, feet) or brain may occur if Caffeine/Ergotamine is taken with certain other medicines, including HIV protease inhibitors (eg, ritonavir) and macrolide antibiotics (eg, erythromycin). Do not use Caffeine/Ergotamine if you are also taking these other medicines. Inform your doctor of all the medicines that you are taking.

Caffeine/Ergotamine is used for:

Preventing and treating certain kinds of headaches (eg, migraines, migraine variants, "histaminic cephalalgia"). It may also be used for other conditions as determined by your doctor.

Caffeine/Ergotamine is a combination of 2 vasoconstrictors. It works by constricting blood vessels in the lining of the brain, which helps to decrease the pain from migraine headaches.

Do NOT use Caffeine/Ergotamine if:

you are allergic to any ingredient in Caffeine/Ergotamine

you are pregnant or may become pregnant

you are in labor

you have blood vessel problems (eg, peripheral vascular disease), coronary heart disease, high blood pressure, liver or kidney problems, or severe infection (eg, sepsis)

you are taking an azole antifungal (eg, itraconazole, ketoconazole, voriconazole), delavirdine, HIV protease inhibitors (eg, delavirdine, indinavir, nelfinavir, ritonavir), efavirenz, a ketolide antibiotic (eg, telithromycin), a macrolide antibiotic (eg, clarithromycin, erythromycin), or selective 5-HT agonists (eg, sumatriptan, eletriptan)

Contact your doctor or health care provider right away if any of these apply to you.

Before using Caffeine/Ergotamine:

Some medical conditions may interact with Caffeine/Ergotamine. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

if you are planning to become pregnant or are breast-feeding

if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement

if you have allergies to medicines, foods, or other substances

if you have a history of blood problems (eg, porphyria), stroke, anxiety, trouble sleeping, or heart problems

if you smoke

Some MEDICINES MAY INTERACT with Caffeine/Ergotamine. Tell your health care provider if you are taking any other medicines, especially any of the following:

Clotrimazole, fluconazole, fluoxetine, fluvoxamine,, metronidazole, nefazodone, saquinavir, or zileuton because side effects of Caffeine/Ergotamine may be increased

Azole antifungals (eg, itraconazole, ketoconazole, voriconazole), beta-blockers (eg, propranolol), delavirdine, HIV protease inhibitors (eg, delavirdine, indinavir, nelfinavir, ritonavir), efavirenz, ketolide antibiotics (eg, telithromycin), macrolide antibiotics (eg, erythromycin, clarithromycin), or selective 5-HT agonists (eg, sumatriptan , eletriptan) because the risk of severe side effects, including irregular heartbeat or decreased oxygen to the extremities (eg, hands, feet) or brain, may be increased

Pressor agents (eg, norepinephrine) or sympathomimetics (eg, pseudoephedrine, albuterol) because risk of side effects, including severe high blood pressure, may be increased

Quinolones (eg, levofloxacin) because risk of side effects, such as nervousness, sleeplessness, and fast heartbeat, may be increased

Theophylline because actions and side effects may be increased by Caffeine/Ergotamine

This may not be a complete list of all interactions that may occur. Ask your health care provider if Caffeine/Ergotamine may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use Caffeine/Ergotamine:

Use Caffeine/Ergotamine as directed by your doctor. Check the label on the medicine for exact dosing instructions.

Caffeine/Ergotamine may be taken with or without food.

Eating grapefruit or drinking grapefruit juice may affect the amount of Caffeine/Ergotamine in your blood. Talk with your doctor before including grapefruit or grapefruit juice in your diet.

Caffeine/Ergotamine is only to be used as needed for a migraine attack.

Take Caffeine/Ergotamine at the first sign of a headache. If the initial dose does not relieve your headache, additional doses may be needed according to your doctor's instructions. Do not take a dose of Caffeine/Ergotamine within 30 minutes of your last dose.

Do not take more than 6 tablets for a single migraine headache or more than 10 tablets during any 7-day period without first checking with your doctor.

If you miss a dose of Caffeine/Ergotamine and you still have a headache, take it as soon as you remember. Do not take a dose of Caffeine/Ergotamine within 30 minutes of your last dose. Do not take 2 doses at once.

Ask your health care provider any questions you may have about how to use Caffeine/Ergotamine.

Important safety information:

Do NOT exceed the recommended dose or take Caffeine/Ergotamine for longer than prescribed without checking with your doctor. Caffeine/Ergotamine is not for long-term daily use.

Do not take Caffeine/Ergotamine for any other kind of headaches. Caffeine/Ergotamine is not effective in treating other types of headaches.

Use of nicotine may increase the risk of severe side effects with Caffeine/Ergotamine. Talk to you doctor before using Caffeine/Ergotamine if you smoke or use any other kind of nicotine.

Use Caffeine/Ergotamine with extreme caution in CHILDREN. Safety and effectiveness have not been confirmed.

PREGNANCY and BREAST-FEEDING: Do not use Caffeine/Ergotamine if you are pregnant. If you suspect that you could be pregnant, contact your doctor immediately. Caffeine/Ergotamine should not be taken during labor and delivery. Caffeine/Ergotamine is excreted in breast milk. If you are or will be breast-feeding while you are using Caffeine/Ergotamine, check with your doctor or pharmacist to discuss the risks to your baby.

When used for long periods of time or at high doses, some people develop a need to continue taking Caffeine/Ergotamine. This is known as DEPENDENCE or addiction. It is important that you take Caffeine/Ergotamine as instructed by your doctor. Caffeine/Ergotamine is not for long-term daily use.

Possible side effects of Caffeine/Ergotamine:

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Nausea.

Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); blue color of the fingers or toes; chest pain or tightness; cold or pale fingers or toes; diarrhea; dizziness; hallucinations; headache; irregular heartbeat; leg cramps or weakness; mental or mood changes; muscle pain; numbness or tingling of the hands, feet, or skin; ringing in the ears; seizure; severe or persistent nausea or vomiting; shortness of breath; swelling; temporary fast or slow heartbeat; vomiting; weak pulse.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

See also: Caffeine/Ergotamine side effects (in more detail)

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately. Symptoms may include chest pain; coma; diarrhea; difficulty breathing; drowsiness; numbness, coldness, pain, tingling, or blue color of the extremities; seizures; severe headache or dizziness; shock; vomiting; weak pulse.

Proper storage of Caffeine/Ergotamine:

Store Caffeine/Ergotamine at room temperature, between 59 and 86 degrees F (15 and 30 degrees C), in a tight, light-resistant container. Store away from heat, moisture, and light. Do not store in the bathroom. Keep Caffeine/Ergotamine out of the reach of children and away from pets.

General information:

If you have any questions about Caffeine/Ergotamine, please talk with your doctor, pharmacist, or other health care provider.

Caffeine/Ergotamine is to be used only by the patient for whom it is prescribed. Do not share it with other people.

If your symptoms do not improve or if they become worse, check with your doctor.

Check with your pharmacist about how to dispose of unused medicine.

This information is a summary only. It does not contain all information about Caffeine/Ergotamine. If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.

Issue Date: February 1, 2012

Database Edition 12.1.1.002

More Caffeine/Ergotamine resources

Caffeine/Ergotamine Side Effects (in more detail)
Caffeine/Ergotamine Dosage
Caffeine/Ergotamine Use in Pregnancy & Breastfeeding
Drug Images
Caffeine/Ergotamine Drug Interactions
Caffeine/Ergotamine Support Group
12 Reviews for Caffeine/Ergotamine - Add your own review/rating

Compare Caffeine/Ergotamine with other medications

Cluster Headaches
Migraine

Cloxacillin

Generic Name: cloxacillin (klox a SILL in)

Brand Names: Cloxapen, Tegopen

What is cloxacillin?

Cloxacillin is an antibiotic in the class of drugs called penicillins. It fights bacteria in your body.

Cloxacillin is used to treat many different types of infections caused by staphylococcus bacteria ("staph" infections).

Cloxacillin may also be used for purposes other than those listed in this medication guide.

What is the most important information I should know about cloxacillin?

Take all of the cloxacillin that has been prescribed for you even if you begin to feel better. Your symptoms may begin to improve before the infection is completely treated. Do not break, chew, open, or crush the capsules. Swallow them whole. Cloxacillin may decrease the effectiveness of birth control pills. Use a second method of birth control while taking cloxacillin to protect against pregnancy.

Who should not take cloxacillin?

If you have ever had an allergic reaction to another penicillin or to a cephalosporin, do not take cloxacillin unless your doctor is aware of your allergy and monitors your therapy.

Before taking this medication, tell your doctor if you have kidney disease, stomach or intestinal disease, or infectious mononucleosis. You may not be able to take cloxacillin because of an increased risk of side effects.

If you are a diabetic, some glucose urine tests may give false positive results while you are taking cloxacillin.

Cloxacillin is in the FDA pregnancy category B. This means that it is unlikely to harm an unborn baby. Do not, however, take cloxacillin without first talking to your doctor if you are pregnant. It is not known whether cloxacillin passes into breast milk. Do not take this medication without first talking to your doctor if you are breast-feeding a baby.

How should I take cloxacillin?

Take cloxacillin exactly as directed by your doctor. If you do not understand these instructions, ask your pharmacist, nurse, or doctor to explain them to you.

Take each dose with a full glass of water. Take cloxacillin on an empty stomach 1 hour before or 2 hours after meals.

Do not drink juice or carbonated beverages (soda) with your dose of cloxacillin. These beverages will decrease the effectiveness of the drug.

Cloxacillin should be taken at evenly spaced intervals throughout the day and night to keep the level in your blood high enough to treat the infection.

Do not crush, chew, or open the capsules. Swallow them whole. Shake the suspension well before measuring a dose. To ensure that you get a correct dose, measure the liquid form of cloxacillin with a dose-measuring spoon or cup, not a regular tablespoon. If you do not have a dose-measuring device, ask your pharmacist where you can get one. Take all of the cloxacillin that has been prescribed for you even if you begin to feel better. Your symptoms may start to improve before the infection is completely treated. Store the capsules at room temperature and store the suspension in the refrigerator for longer use. The suspension is good for 14 days if it is stored in the refrigerator. Throw away any unused liquid after this amount of time.

What happens if I miss a dose?

Take the missed dose as soon as you remember. However, if it is almost time for your next dose, skip the dose you missed and take only your next regularly scheduled dose. Do not take a double dose of this medication unless otherwise directed by your doctor.

If you have only missed one dose, you can take the rest of your scheduled doses for the day at evenly spaced intervals.

What happens if I overdose?

Seek emergency medical attention.

Symptoms of an cloxacillin overdose include muscle spasms or weakness, pain or twitching, pain in the fingers or toes, loss of feeling in the fingers or toes, seizures, confusion, coma, and agitation.

What should I avoid while taking cloxacillin?

Alcohol may irritate your stomach if taken with cloxacillin, so use it with moderation.

Cloxacillin side effects

If you experience any of the following serious side effects, stop taking cloxacillin and seek emergency medical attention:

an allergic reaction (shortness of breath; closing of your throat; hives; swelling of your lips, face, or tongue; rash; or fainting);

seizures;

severe watery diarrhea and abdominal cramps; or

unusual bleeding or bruising.

Other, less serious side effects maybe more likely to occur. Continue to take cloxacillin and talk to your doctor if you experience

mild nausea, vomiting, diarrhea, or abdominal pain;

white patches on the tongue (thrush/yeast infection);

itching or discharge of the vagina (vaginal yeast infection); or

black, "hairy" tongue or sore mouth or tongue.

Side effects other than those listed here may also occur. Talk to your doctor about any side effect that seems unusual or that is especially bothersome.

Cloxacillin Dosing Information

Usual Adult Dose for Upper Respiratory Tract Infection:

250 mg orally every 6 hours for 7 to 14 days, depending on the nature and severity of the infection.

Maximum dose: 4 g/day.

Usual Adult Dose for Pneumonia:

500 mg orally every 6 hours for up to 21 days, depending on the nature and severity of the infection.

Maximum dose: 4 g/day.

Usual Adult Dose for Skin and Structure Infection:

500 mg orally every 6 hours for 7 days, or until 3 days after acute inflammation resolves, depending on the nature and severity of the infection.

Maximum dose: 4 g/day.

Usual Adult Dose for Cystitis:

250 mg orally every 6 hours for 3 to 7 days, depending on the nature and severity of the infection. Cloxacillin is rarely indicated for the treatment of cystitis.

Maximum dose: 4 g/day.

Usual Pediatric Dose for Pneumonia:

The safety and efficacy of cloxacillin in children
>= 1 year to 18 years: 50 to 100 mg/kg/day orally divided every 6 hours.

Maximum dose: 4 g/day.

Usual Pediatric Dose for Upper Respiratory Tract Infection:

The safety and efficacy of cloxacillin in children
>= 1 year to 18 years: 50 to 100 mg/kg/day orally divided every 6 hours.

Maximum dose: 4 g/day.

Usual Pediatric Dose for Skin and Structure Infection:

The safety and efficacy of cloxacillin in children
>= 1 year to 18 years: 50 to 100 mg/kg/day orally divided every 6 hours.

Maximum dose: 4 g/day.

What other drugs will affect cloxacillin?

Some drugs may decrease the effects of cloxacillin and prevent it from properly treating your infection. Before taking cloxacillin, tell your doctor if you are taking any of the following drugs:

cholestyramine (Questran) or colestipol (Colestid); or

another antibiotic (for the same or for a different infection) such as erythromycin (Ery-Tab, E-Mycin, E.E.S., others), tetracycline (Sumycin, others), minocycline (Minocin), doxycycline (Doryx, Vibramycin, others), or any other.

Cloxacillin may decrease the effectiveness of birth control pills. Use a second method of birth control while taking cloxacillin to protect against pregnancy.

Cloxacillin increases the effects of methotrexate, and you may need a dose adjustment during therapy with cloxacillin.

Cloxacillin also increases the side effects of allopurinol (Zyloprim) and may cause a rash.

Probenecid (Benemid) increases the effects of cloxacillin. These drugs may be used together for this purpose; however, be sure your doctor is aware if you are taking probenecid. You may need a lower dose of cloxacillin.

Drugs other than those listed here may also interact with cloxacillin. Talk to your doctor and pharmacist before taking any prescription or over-the-counter medicines.

More cloxacillin resources

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

Cloxapen Advanced Consumer (Micromedex) - Includes Dosage Information

Compare cloxacillin with other medications

Bladder Infection
Pneumonia
Skin and Structure Infection
Upper Respiratory Tract Infection

Where can I get more information?

Your pharmacist has additional information about cloxacillin written for health professionals that you may read.

What does my medication look like?

Cloxacillin is available generically and with a prescription in 250 and 500 mg capsules and in a suspension formulation of 120 mg per 5 mL (1 teaspoon). Other brand or generic formulations may also be available. Ask your pharmacist any questions you have about this medication, especially if it is new to you.

See also: cloxacillin side effects (in more detail)

Sunday, November 13, 2016

Xeomin

Pronunciation: IN-koe-BOT-ue-LYE-num-TOX-in-AY
Generic Name: IncobotulinumtoxinA
Brand Name: Xeomin

Xeomin may spread from the injection site to other areas of the body, causing symptoms of a serious condition called botulism. These symptoms may occur hours to weeks after you receive Xeomin. Symptoms may include loss of strength; muscle weakness; double or blurred vision; drooping eyelids; hoarseness; change or loss of voice; loss of bladder control; or trouble speaking, breathing, or swallowing. The risk may be greater in children being treated for spasticity (muscle spasms), but these symptoms may also occur in adults. Contact your doctor immediately if these symptoms occur.

Severe and sometimes fatal breathing or swallowing problems have been reported. The risk may be greater in patients who already have breathing or swallowing problems. Tell your doctor if you have or are at risk of developing breathing or swallowing problems.

Xeomin is used for:

Reducing the severity of abnormal head position and neck pain associated with neck problems. It may be used to treat certain types of eyelid muscle spasms after you have been treated with another medicine (onabotulinumtoxinA). It may be used to temporarily improve the appearance of moderate to severe lines between the eyebrows in certain patients. It may also be used for other conditions as determined by your doctor.

Xeomin is a neurotoxin. It works by blocking nerve impulses to the muscles, temporarily paralyzing the muscle.

Do NOT use Xeomin if:

you are allergic to any ingredient in Xeomin, including botulinum neurotoxin type A, human albumin, sucrose, or to another botulinum toxin product

you have an infection at the injection site

Contact your doctor or health care provider right away if any of these apply to you.

Before using Xeomin:

Some medical conditions may interact with Xeomin. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

if you are pregnant, planning to become pregnant, or are breast-feeding

if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement

if you have allergies to medicines, foods, or other substances

if you have nerve problems or disease (eg, amyotrophic lateral sclerosis, motor neuropathy), muscle problems or disease (eg, myasthenia gravis, Lambert-Eaton syndrome), bleeding problems, or severe weakness or wasting of the muscles at the injection site

if you have a history of swallowing problems or aspiration (inhaling food or fluids into your lungs), breathing problems (eg, asthma, emphysema), eye problems (eg, glaucoma, drooping eyelid), or eye surgery

if you have a skin infection, or inflammation, scarring, or other skin disorders at the injection site

if you plan to have surgery or if you have received Xeomin or any other botulinum toxin in the past, especially within the last 4 months

if you have weakness in your forehead muscles, any change in the way your face normally looks, you plan to have surgery, or you have had surgery on your face

if you are taking an allergy or cold medicine

Some MEDICINES MAY INTERACT with Xeomin. Tell your health care provider if you are taking any other medicines, especially any of the following:

Aminoglycoside antibiotics (eg, gentamicin), muscle relaxants (eg, cyclobenzaprine), or sleep medicines (eg, zolpidem) because they may increase the risk of Xeomin's side effects

Anticoagulants (eg, warfarin) because the risk of bleeding at the injection site may be increased

This may not be a complete list of all interactions that may occur. Ask your health care provider if Xeomin may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use Xeomin:

Use Xeomin as directed by your doctor. Check the label on the medicine for exact dosing instructions.

Xeomin comes with an extra patient information sheet called a Medication Guide. Read it carefully. Read it again each time you get Xeomin refilled.

Xeomin is usually given as an injection at your doctor's office, hospital, or clinic.

If you miss a dose of Xeomin, contact your doctor right away.

Ask your health care provider any questions you may have about how to use Xeomin.

Important safety information:

Xeomin may cause dizziness, loss of strength, weakness, or blurred vision. These effects may be worse if you take it with alcohol or certain medicines. Use Xeomin with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.

Do NOT use more than the recommended dose or use for longer than prescribed without checking with your doctor.

Tell your doctor or dentist that you take Xeomin before you receive any medical or dental care, emergency care, or surgery.

Do not switch brands of Xeomin or switch it with other botulinum toxin products. Contact your doctor if you have any questions.

Xeomin contains albumin, which comes from human blood. There is a very rare risk of getting a viral disease or a central nervous system disease called Creutzfeldt-Jakob disease from products with albumin. No cases of these problems have been found in patients who have used Xeomin.

To prevent injury, resume normal activities gradually after using Xeomin.

Xeomin should be used with extreme caution in CHILDREN younger than 18 years old; safety and effectiveness in these children have not been confirmed.

PREGNANCY and BREAST-FEEDING: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Xeomin while you are pregnant. It is not known if Xeomin is found in breast milk. If you are or will be breast-feeding while you use Xeomin, check with your doctor. Discuss any possible risks to your baby.

Possible side effects of Xeomin:

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Decreased blinking; diarrhea; dry mouth; dry or irritated eyes; headache; increased cough; muscle or bone pain; muscle weakness or spasms; nausea; neck pain; pain, redness, swelling, or tenderness at the injection site; runny nose; tiredness.

Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue; unusual hoarseness); bleeding at the injection site; difficulty swallowing or breathing; dizziness; double or blurred vision or other vision changes; drooping of the upper eyelid; eye or eyelid swelling; eye pain or irritation; fainting; fever, chills, or persistent sore throat; loss of bladder control; loss of strength; severe or persistent muscle weakness or spasms; shortness of breath; speech changes or problems; wheezing.

See also: Xeomin side effects (in more detail)

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately. Symptoms may include body weakness; difficulty breathing; paralysis. Xeomin may be harmful if swallowed.

Proper storage of Xeomin:

Xeomin is usually handled and stored by a health care provider. If you are using Xeomin at home, store Xeomin as directed by your pharmacist or health care provider. Keep Xeomin out of the reach of children and away from pets.

General information:

If you have any questions about Xeomin, please talk with your doctor, pharmacist, or other health care provider.

Xeomin is to be used only by the patient for whom it is prescribed. Do not share it with other people.

If your symptoms do not improve or if they become worse, check with your doctor.

Check with your pharmacist about how to dispose of unused medicine.

This information is a summary only. It does not contain all information about Xeomin. If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.

Issue Date: February 1, 2012

Database Edition 12.1.1.002

More Xeomin resources

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

Xeomin Prescribing Information (FDA)

Xeomin Advanced Consumer (Micromedex) - Includes Dosage Information

Xeomin Consumer Overview

IncobotulinumtoxinA Professional Patient Advice (Wolters Kluwer)

Compare Xeomin with other medications

Blepharospasm
Cervical Dystonia
Facial Wrinkles

Hydroquinone with Sunscreen Cream

Pronunciation: HYE-droe-KWIN-ane
Generic Name: Hydroquinone with Sunscreen
Brand Name: Examples include Esoterica Sunscreen Formula and Solaquin Forte

Hydroquinone with Sunscreen Cream is used for:

Lightening freckles, age spots, and other skin discolorations associated with pregnancy, skin trauma, birth control pills, or hormone replacement therapy. It may also be used for other conditions as determined by your doctor.

Hydroquinone with Sunscreen Cream is a skin-bleaching agent. It works by blocking a reaction in the skin cells that produce melanin, which darkens the pigment of the skin. With less melanin available, the color of the skin fades.

Do NOT use Hydroquinone with Sunscreen Cream if:

you are allergic to any ingredient in Hydroquinone with Sunscreen Cream

Contact your doctor or health care provider right away if any of these apply to you.

Before using Hydroquinone with Sunscreen Cream:

Some medical conditions may interact with Hydroquinone with Sunscreen Cream. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

if you are pregnant, planning to become pregnant, or are breast-feeding

if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement

if you have allergies to medicines, foods, or other substances

if you have asthma

Some MEDICINES MAY INTERACT with Hydroquinone with Sunscreen Cream. Because little, if any, of Hydroquinone with Sunscreen Cream is absorbed into the blood, the risk of it interacting with another medicine is low.

Ask your health care provider if Hydroquinone with Sunscreen Cream may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use Hydroquinone with Sunscreen Cream:

Use Hydroquinone with Sunscreen Cream as directed by your doctor. Check the label on the medicine for exact dosing instructions.

Before using Hydroquinone with Sunscreen Cream for the first time, apply a small amount to an unbroken patch of skin and check in 24 hours for itching, blistering, or excessive redness or irritation. If these effects develop, contact your doctor and soon as possible and do not use Hydroquinone with Sunscreen Cream on other areas.

Wash and completely dry the affected areas. Gently rub the medicine in until it is evenly distributed. Wash your hands immediately after using Hydroquinone with Sunscreen Cream, unless your hands are part of the treated area.

If you miss a dose of Hydroquinone with Sunscreen Cream, use it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not use 2 doses at once.

Ask your health care provider any questions you may have about how to use Hydroquinone with Sunscreen Cream.

Important safety information:

Protect your skin from the sun during and after the use of Hydroquinone with Sunscreen Cream. Limit sun exposure and wear protective clothing to cover the treated areas. Hydroquinone with Sunscreen Cream contains a sunscreen. Ask your doctor or pharmacist if the use of additional sunscreen is necessary.

Hydroquinone with Sunscreen Cream is for external use only. Avoid getting Hydroquinone with Sunscreen Cream in your eyes, nose, or mouth, or on your lips. If you get Hydroquinone with Sunscreen Cream in your eyes, wash them out with water and contact your doctor. If you get Hydroquinone with Sunscreen Cream on your lips or in your nose or mouth, rinse with water.

Do not use Hydroquinone with Sunscreen Cream on irritated or injured skin.

If your symptoms do not improve within 2 months or if they get worse, check with your doctor.

Do not use Hydroquinone with Sunscreen Cream over large areas of the body without checking with your doctor.

Do not use Hydroquinone with Sunscreen Cream with products that contain hydrogen peroxide or benzoyl peroxide. This may cause a dark staining of your skin. The staining can be removed by stopping use of the peroxide and washing your skin with soap and water.

Do not use Hydroquinone with Sunscreen Cream with other medicines containing resorcinol, phenol, or salicylic acid unless otherwise directed by your doctor.

Some of these products contain sulfites. Sulfites may cause an allergic reaction in some patients (eg, asthma patients). If you have ever had an allergic reaction to sulfites, ask your pharmacist if your product has sulfites in it.

Hydroquinone with Sunscreen Cream should not be used in CHILDREN younger than 12 years old; safety and effectiveness in these children have not been confirmed.

PREGNANCY and BREAST-FEEDING: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Hydroquinone with Sunscreen Cream while you are pregnant. It is not known if Hydroquinone with Sunscreen Cream is found in breast milk. If you are or will be breast-feeding while you use Hydroquinone with Sunscreen Cream, check with your doctor. Discuss any possible risks to your baby.

Possible side effects of Hydroquinone with Sunscreen Cream:

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Dryness or cracking of the skin if applied around eyes or nose; minor redness or mild burning sensation at application site.

Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); blistered skin or excessive redness, stinging, or irritation.

See also: Hydroquinone with Sunscreen side effects (in more detail)

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately.

Proper storage of Hydroquinone with Sunscreen Cream:

Store Hydroquinone with Sunscreen Cream at room temperature, between 59 and 86 degrees F (15 and 30 degrees C). Store away from heat, moisture, and light. Keep Hydroquinone with Sunscreen Cream out of the reach of children and away from pets.

General information:

If you have any questions about Hydroquinone with Sunscreen Cream, please talk with your doctor, pharmacist, or other health care provider.

Hydroquinone with Sunscreen Cream is to be used only by the patient for whom it is prescribed. Do not share it with other people.

If your symptoms do not improve or if they become worse, check with your doctor.

Check with your pharmacist about how to dispose of unused medicine.

This information is a summary only. It does not contain all information about Hydroquinone with Sunscreen Cream. If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.

Issue Date: February 1, 2012

Database Edition 12.1.1.002

More Hydroquinone with Sunscreen resources

Hydroquinone with Sunscreen Side Effects (in more detail)
Hydroquinone with Sunscreen Use in Pregnancy & Breastfeeding
Hydroquinone with Sunscreen Support Group
2 Reviews for Hydroquinone with Sunscreen - Add your own review/rating

Compare Hydroquinone with Sunscreen with other medications

Dermatological Disorders

Calcium Citrate

Pronunciation: KAL-see-um SIT-rate with VYE-ta-min D
Generic Name: Calcium Citrate
Brand Name: Examples include Citracal+D and Citracal Petites/Vitamin D

Calcium Citrate is used for:

Treating or preventing calcium deficiency. It may also be used for other conditions as determined by your doctor.

Calcium Citrate is a dietary supplement. It works by providing extra calcium to the body.

Do NOT use Calcium Citrate if:

you are allergic to any ingredient in Calcium Citrate

you have high blood calcium levels or high blood vitamin D levels

you take aluminum salts (eg, aluminum chloride)

Contact your doctor or health care provider right away if any of these apply to you.

Before using Calcium Citrate:

Some medical conditions may interact with Calcium Citrate. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

if you are pregnant, planning to become pregnant, or are breast-feeding

if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement

if you have allergies to medicines, foods, or other substances

if you have high blood phosphate levels or high levels of calcium in the urine

if you have dehydration, heart problems, hardening of the arteries, kidney problems, kidney stones, or sarcoidosis

if you take digoxin

Some MEDICINES MAY INTERACT with Calcium Citrate. Tell your health care provider if you are taking any other medicines, especially any of the following:

Iron, quinolones (eg, ciprofloxacin), sodium polystyrene sulfonate, tetracyclines (eg, doxycycline), thyroid hormones, or verapamil because their effectiveness may be decreased by Calcium Citrate

This may not be a complete list of all interactions that may occur. Ask your health care provider if Calcium Citrate may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use Calcium Citrate:

Use Calcium Citrate as directed by your doctor. Check the label on the medicine for exact dosing instructions.

Take Calcium Citrate by mouth with or without food.

Take Calcium Citrate with a full glass of water (8 oz/240 mL).

Do not take an antacid that has aluminum in it within 1 hour before or 2 hours after you take Calcium Citrate.

If you miss a dose of Calcium Citrate, take it as soon as you remember. Continue to take it as directed by your doctor or on the package label.

Ask your health care provider any questions you may have about how to use Calcium Citrate.

Important safety information:

Do not take large doses of vitamins while you use Calcium Citrate unless your doctor tells you to.

Tell your doctor or dentist that you take Calcium Citrate before you receive any medical or dental care, emergency care, or surgery.

This product may contain tartrazine dye (FD&C Yellow No. 5). This may cause an allergic reaction in some patients. If you have ever had an allergic reaction to tartrazine, ask your pharmacist if your product has tartrazine in it.

Lab tests, including serum calcium levels, may be performed while you use Calcium Citrate. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.

Calcium Citrate should be used with extreme caution in CHILDREN; safety and effectiveness in children have not been confirmed.

PREGNANCY and BREAST-FEEDING: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Calcium Citrate while you are pregnant. It is not known if Calcium Citrate is found in breast milk. If you are or will be breast-feeding while you use Calcium Citrate, check with your doctor. Discuss any possible risks to your baby.

Possible side effects of Calcium Citrate:

All medicines may cause side effects, but many people have no, or minor side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Constipation; headache.

Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); loss of appetite; nausea; severe or persistent constipation; vomiting.

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately. Symptoms may include confusion; delirium; loss of consciousness; mood or mental changes.

Proper storage of Calcium Citrate:

Store Calcium Citrate at room temperature, between 59 and 86 degrees F (15 and 30 degrees C). Store away from heat, moisture, and light. Do not store in the bathroom. Keep Calcium Citrate out of the reach of children and away from pets.

General information:

If you have any questions about Calcium Citrate, please talk with your doctor, pharmacist, or other health care provider.

Calcium Citrate is to be used only by the patient for whom it is prescribed. Do not share it with other people.

If your symptoms do not improve or if they become worse, check with your doctor.

Check with your pharmacist about how to dispose of unused medicine.

This information is a summary only. It does not contain all information about Calcium Citrate. If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.

Issue Date: February 1, 2012

Database Edition 12.1.1.002

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