Cesamet

nabilone

Dosage Form: capsule
Cesamet® CII

(nabilone)

Capsules

For Oral Administration

Cesamet Description

Cesamet® (nabilone) is a synthetic cannabinoid for oral administration. Nabilone as a raw material occurs as a white to off-white polymorphic crystalline powder. In aqueous media, the solubility of nabilone is less than 0.5 mg/L, with pH values ranging from 1.2 to 7.0.

Chemically, nabilone is similar to the active ingredient found in naturally occurring Cannabis sativa L. [Marijuana; delta-9-tetrahydrocannabinol (delta-9-THC)]. Nabilone is (±) - trans - 3 - (1,1 - dimethylheptyl) - 6,6a,7,8,10,10a - hexahydro - 1 - hydroxy - 6 - 6 - dimethyl - 9H - dibenzo[b,d]pyran - 9 - one and has the empirical formula C24H36O3. It has a molecular weight of 372.55. The structural formula is as follows:

Each 1 mg Cesamet capsule contains 1 mg of nabilone and the following inactive ingredients: povidone and corn starch. The capsule shells contain the following inactive ingredients: FD&C Blue No. 2 (indigo carmine), red iron oxide, gelatin, and titanium dioxide.

Cesamet - Clinical Pharmacology

Pharmacodynamics

Cesamet (nabilone) is an orally active synthetic cannabinoid which, like other cannabinoids, has complex effects on the central nervous system (CNS). It has been suggested that the antiemetic effect of nabilone is caused by interaction with the cannabinoid receptor system, i.e., the CB (1) receptor, which has been discovered in neural tissues.

Nontherapeutic Effects: Cesamet, a synthetic cannabinoid, has the potential to be abused and to produce psychological dependence. Cesamet has complex effects on the central nervous system. Its effects on the mental state (i.e., "inner mental life") are similar to those of cannabis. Subjects given Cesamet may experience changes in mood (euphoria, detachment, depression, anxiety, panic, paranoia), decrements in cognitive performance and memory, a decreased ability to control drives and impulses, and alterations in the experience of reality (e.g., distortions in the perception of objects and the sense of time, hallucinations). These phenomena appear to be more common when larger doses of Cesamet are administered; however, a full-blown picture of psychosis (psychotic organic brain syndrome) may occur in patients receiving doses within the lower portion of the therapeutic range.

Data on the chronic use of Cesamet are not available; experience with cannabis suggests that chronic use of cannabinoids may be associated with a variety of untoward effects on motivation, cognition, judgment, as well as other mental status changes. Whether these phenomena reflect the underlying character of individuals chronically abusing cannabis or are a result of the use of cannabis is not known.

The simultaneous use of Cesamet and alcohol or barbiturates may produce additive depressive effects on central nervous system function. Possible changes in mood and other adverse behavioral effects may occur in patients receiving Cesamet. Patients should remain under supervision of a responsible adult while using Cesamet.

Cesamet has central nervous system activity. It produces relaxation, drowsiness, and euphoria in the recommended dosage range. Tolerance to these effects develops rapidly and is readily reversible.

In addition to effects on the mental state, Cesamet has several systemic actions; most prominent are dry mouth and hypotension. Cesamet has been observed to elevate supine and standing heart rates and to cause supine and orthostatic hypotension. In clinical studies, oral administration of 2 mg of Cesamet did produce some decrease in airway resistance in normal controls but had no effect in patients with asthma. No other nontherapeutic effects of clinical significance due to Cesamet have been reported.

Pharmacokinetics

Absorption and Distribution: Cesamet (nabilone) appears to be completely absorbed from the human gastrointestinal tract when administered orally. Following oral administration of a 2 mg dose of radiolabeled nabilone, peak plasma concentrations of approximately 2 ng/mL nabilone and 10 ng equivalents/mL total radioactivity are achieved within 2.0 hours. The plasma half-life (T1/2) values for nabilone and total radioactivity of identified and unidentified metabolites are about 2 and 35 hours, respectively. The initial rapid disappearance of radioactivity represents uptake and distribution of nabilone into tissue and the slower phase elimination by metabolism and excretion. The apparent volume of distribution of nabilone is about 12.5 L/kg.

Nabilone exhibits dose linearity within its therapeutic range. Clinical data suggests that the intake of food does not significantly affect either the rate or extent of absorption.

Metabolism: Metabolism of nabilone is extensive and several metabolites have been identified. Precise information concerning the metabolites that may accumulate is not available. The relative activities of the metabolites and the parent drug have not been established. There are at least two metabolic pathways involved in the biotransformation of nabilone. A minor pathway is initiated by the stereospecific enzymatic reduction of the 9-keto moiety of nabilone to produce the isomeric carbinol metabolite. The peak concentrations of nabilone and its carbinol metabolites are comparable, but their combined exposures in plasma do not account for more than 20% of that of total radioactivity. Secondly, a metabolite of nabilone in feces has been identified as a diol formed by reduction of the 9-keto group plus oxidation at the penultimate carbon of the dimethylheptyl side chain. In addition, there is evidence of extensive metabolism of Cesamet by multiple P450 enzyme isoforms. In vitro P450 inhibition studies using human liver microsomes showed that nabilone did not significantly inhibit CYP1A2, 2A6, 2C19, 2D6, and 3A4 (using midazolam and nifedipine as substrates). Nabilone had a weak inhibitory effect on CYP 2E1 and 3A4 (testosterone IC50 > 50 µM) and had a moderate inhibitory effect on CYP2C8 and 2C9 (IC50 > 10 µM). However, in clinical use, the very low nabilone plasma concentration is unlikely to interfere with the P450-mediated degradation of co-administered drugs. Chronic oral administration of 1 mg t.i.d. for 14 days to 3 subjects gave no indication there was any significant accumulation of nabilone. Available evidence suggests that one or more of the metabolites has a terminal elimination half-life that exceeds that of nabilone. Consequently, in repeated use, the metabolites may accumulate at concentrations in excess of the parent drug.

Elimination: The route and rate of the elimination of nabilone and its metabolites are similar to those observed with other cannabinoids, including delta-9-THC (dronabinol). When nabilone is administered intravenously, the drug and its metabolites are eliminated mainly in the feces (approximately 67%) and to a lesser extent in the urine (approximately 22%) within 7 days. Of the 67% recovered from the feces, 5% corresponded to the parent compound and 16% to its carbinol metabolite. Following oral administration about 60% of nabilone and its metabolites were recovered in the feces and about 24% in urine. Therefore, it appears that the major excretory pathway is the biliary system.

The effects of age, gender, hepatic dysfunction, and renal insufficiency on the metabolism and elimination of nabilone have not been determined.

Special Populations: The pharmacokinetic profile of Cesamet has not been investigated in either pediatric (See PRECAUTIONS, Pediatric Use) or geriatric patients (See PRECAUTIONS, Geriatric Use).

Clinical Trials

Cesamet was evaluated for its effectiveness and safety in the treatment of nausea and vomiting induced by cancer chemotherapy in patients receiving a wide variety of chemotherapy regimens, including low-dose cisplatin (20 mg/m2) in both placebo-controlled and active controlled (prochlorperazine) trials.

During Cesamet treatment patients reported a higher incidence of adverse effects. The most frequent were drowsiness, vertigo, dry mouth and euphoria. However, most of the adverse effects occurring with Cesamet were of mild to moderate severity (See ADVERSE REACTIONS).

Indications and Usage for Cesamet

Cesamet capsules are indicated for the treatment of the nausea and vomiting associated with cancer chemotherapy in patients who have failed to respond adequately to conventional antiemetic treatments. This restriction is required because a substantial proportion of any group of patients treated with Cesamet can be expected to experience disturbing psychotomimetic reactions not observed with other antiemetic agents.

Because of its potential to alter the mental state, Cesamet is intended for use under circumstances that permit close supervision of the patient by a responsible individual particularly during initial use of Cesamet and during dose adjustments.

Cesamet contains nabilone, which is controlled in Schedule II of the Controlled Substances Act. Schedule II substances have a high potential for abuse. Prescriptions for Cesamet should be limited to the amount necessary for a single cycle of chemotherapy (i.e., a few days).

Cesamet capsules are not intended to be used on as needed basis or as a first antiemetic product prescribed for a patient.

As with all controlled drugs, prescribers should monitor patients receiving nabilone for signs of excessive use, abuse and misuse. Patients who may be at increased risk for substance abuse include those with a personal or family history of substance abuse (including drug or alcohol abuse) or mental illness.

Contraindications

Cesamet is contraindicated in any patient who has a history of hypersensitivity to any cannabinoid.

Warnings

• The effects of Cesamet may persist for a variable and unpredictable period of time following its oral administration. Adverse psychiatric reactions can persist for 48 to 72 hours following cessation of treatment.


• Cesamet has the potential to affect the CNS, which might manifest itself in dizziness, drowsiness, euphoria “high”, ataxia, anxiety, disorientation, depression, hallucinations and psychosis.


• Cesamet can cause tachycardia and orthostatic hypotension.


• Because of individual variation in response and tolerance to the effects of Cesamet, patients should remain under supervision of a responsible adult especially during initial use of Cesamet and during dose adjustments.


• Patients receiving treatment with Cesamet should be specifically warned not to drive, operate machinery, or engage in any hazardous activity while receiving Cesamet.


• Cesamet should not be taken with alcohol, sedatives, hypnotics, or other psychoactive substances because these substances can potentiate the central nervous system effects of nabilone.

Precautions

General

The benefit/risk ratio of Cesamet use should be carefully evaluated in patients with the following medical conditions because of individual variation in response and tolerance to the effects of Cesamet.

• Since Cesamet can elevate supine and standing heart rates and cause postural hypotension, it should be used with caution in the elderly, and in patients with hypertension or heart disease.


• Cesamet should also be used with caution in patients with current or previous psychiatric disorders, (including manic depressive illness, depression, and schizophrenia) as the symptoms of these disease states may be unmasked by the use of cannabinoids.


• Cesamet should be used with caution in individuals receiving concomitant therapy with sedatives, hypnotics, or other psychoactive drugs because of the potential for additive or synergistic CNS effects.


• Cesamet should be used with caution in patients with a history of substance abuse, including alcohol abuse or dependence and marijuana use, since Cesamet contains a similar active compound to marijuana.


• The safety aspects of the effects of hepatic and renal impairment have not been investigated.


• Nabilone is purportedly highly bound to plasma proteins and undergoes extensive first pass hepatic metabolism. Those properties have the potential to lead to drug-drug interactions affecting the pharmacokinetics of similar behaving co-administered drugs or of Cesamet itself.


• The effects of QT prolongation potential by Cesamet have not been determined.


• Cesamet should be used with caution in pregnant patients, nursing mothers, or pediatric patients because it has not been studied in these patient populations.

Information for Patients

Persons taking Cesamet should be alerted to the potential for additive central nervous system depression resulting from simultaneous use of Cesamet and alcohol or other central nervous system depressants such as benzodiazepines and barbiturates. This combination should be avoided. Patients receiving treatment with Cesamet should be specifically warned not to drive, operate machinery, or engage in any hazardous activity. Patients using Cesamet should be made aware of possible changes in mood and other adverse behavioral effects of the drug so as to avoid panic in the event of such manifestations. Patients should remain under supervision of a responsible adult while using Cesamet.

Drug Interactions

Potential interactions between Cesamet 2 mg, and diazepam 5 mg; sodium secobarbital 100 mg; alcohol 45 mL (absolute laboratory alcohol); or codeine 65 mg, were evaluated in 15 subjects. Only a single combination was utilized at any one time. The subjects were evaluated according to physiologic (i.e., heart rate and blood pressure), psychometric, psychomotor, and subjective parameters. In this study, as expected, the depressant effects of the combinations were additive. Psychomotor function was particularly impaired with concurrent use of diazepam. Caution must thus be used when administering nabilone in combination with any CNS depressant.

Nabilone is purportedly highly bound to plasma proteins, and therefore, might displace other protein-bound drugs. Therefore, practitioners should monitor patients for a change in dosage requirements when administering nabilone to patients receiving other highly protein-bound drugs. Published reports of drug-drug interactions involving cannabinoids are summarized in the following table.

CONCOMITANT DRUG	CLINICAL EFFECT(S)
Amphetamines, cocaine, other sympathomimetic agents	Additive hypertension, tachycardia, possibly cardiotoxicity
Atropine, scopolamine, antihistamines, other anticholinergic agents	Additive or super-additive tachycardia, drowsiness
Amitriptyline, amoxapine, desipramine, other tricyclic antidepressants	Additive tachycardia, hypertension, drowsiness
Barbiturates, benzodiazepines, ethanol, lithium, opioids, buspirone, antihistamines, muscle relaxants, other CNS depressants	Additive drowsiness and CNS depression
Disulfiram	A reversible hypomanic reaction was reported in a 28 y/o man who smoked marijuana; confirmed by dechallenge and rechallenge
Fluoxetine	A 21 y/o female with depression and bulimia receiving 20 mg/day fluoxetine X 4 wks became hypomanic after smoking marijuana; symptoms resolved after 4 days
Antipyrine, barbiturates	Decreased clearance of these agents, presumably via competitive inhibition of metabolism
Theophylline	Increased theophylline metabolism reported with smoking of marijuana; effect similar to that following smoking tobacco
Opioids	Cross-tolerance and mutual potentiation
Naltrexone	Oral THC effects were enhanced by opioid receptor blockade.
Alcohol	Increase in the positive subjective mood effects of smoked marijuana

Animal Pharmacology and/or Toxicology

Monkeys treated with Cesamet at doses as high as 2 mg/kg/day for a year experienced no significant adverse events. This result contrasts with the findings in a planned 1-year dog study that was prematurely terminated because of deaths associated with convulsions in dogs receiving as little as 0.5 mg/kg/day. The earliest deaths, however, occurred at 56 days in dogs receiving 2 mg/kg/day. The unusual vulnerability of the dog to Cesamet is not understood; it is hypothesized, however, that the explanation lies in the fact that the dog differs markedly from other species in its metabolism of Cesamet.

Carcinogenesis, Mutagenesis, Impairment of Fertility

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

Nabilone was not genotoxic in the Ames test, the rat hepatocyte unscheduled DNA synthesis (UDS) test, the Chinese hamster bone marrow cell sister chromatid exchange (SCE) test, the male rat dominant lethal tests nor the rat micronucleus test.

Dietary administration of nabilone up to 4 mg/kg/day (about 6 times the recommended maximum human dose based on body surface area) was found to have no effect on fertility and reproductive performance of male and female rats.

Pregnancy: Teratogenic Effects. Pregnancy Category C

Teratology studies conducted in pregnant rats at doses up to 12 mg/kg/day (about 16 times the human dose on a body surface area basis) and in pregnant rabbits at doses up to 3.3 mg/kg/day (about 9 times the human dose on a body surface area basis) did not disclose any evidence for a teratogenic potential of nabilone. However, there was dose related developmental toxicity in both species as evidenced by increases in embryo lethality, fetal resorptions, decreased fetal weights and pregnancy disruptions. In rats, postnatal developmental toxicity was also observed. There are no adequate and well-controlled studies in pregnant women. Because animal studies cannot rule out the possibility of harm, Cesamet should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

Nursing Mothers

It is not known whether this drug is excreted in breast milk. Because many drugs including some cannabinoids are excreted in breast milk it is not recommended that Cesamet be given to nursing mothers.

Pediatric Use

Safety and effectiveness have not been established in patients younger than 18 years of age. Caution is recommended in prescribing Cesamet to children because of psychoactive effects.

Geriatric Use

Clinical studies of Cesamet did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy. Cesamet should be used with caution in elderly patients aged 65 and over because they are generally more sensitive to the psychoactive effects of drugs and Cesamet can elevate supine and standing heart rates and cause postural hypotension.

Adverse Reactions

To report SUSPECTED ADVERSE REACTIONS, contact Meda Pharmaceuticals Inc. at 1-800-526-3840 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Commonly Encountered Reactions: During controlled clinical trials of Cesamet, virtually all patients experienced at least one adverse reaction. The most commonly encountered events were drowsiness, vertigo, dry mouth, euphoria (feeling “high”), ataxia, headache, and concentration difficulties.

Comparative Incidence of Reactions: Accurate estimates of the incidence of adverse events associated with the use of any drug are difficult to obtain. Estimates are influenced by factors such as drug dose, detection technique, setting, and physician judgments, among others. Consequently, the tables presented below are presented solely to indicate the relative frequency of adverse events reported in representative controlled clinical studies conducted to evaluate the safety and efficacy of Cesamet under relatively similar conditions of use. The figures cited cannot be used to predict precisely the incidence of untoward events in the course of usual medical practice, in which patient characteristics and other factors may differ from those that prevailed in the clinical trials. These incidence figures also cannot be compared with those obtained from other clinical studies involving related drug products because each group of drug trials is conducted under a different set of conditions.

Finally, it is important to emphasize that these tabulations do not reflect the relative severity and/or clinical importance of the adverse events. A better perspective on the serious adverse events associated with the use of Cesamet is provided in the WARNINGS and PRECAUTIONS sections.

The following tables list in order of decreasing frequency the adverse reactions encountered by a substantial proportion of patients treated with Cesamet participating in representative controlled clinical trials.

Incidence of Adverse Reactions in Placebo-Controlled Studies
	Nabilone (n=132)		Placebo (n=119)
Adverse Event	Patients	Percent	Patients	Percent
Vertigo	69	52	3	3
Drowsiness	69	52	6	5
Dry Mouth	47	36	2	2
Ataxia	19	14	0	0
Euphoria	14	11	1	1
Sleep Disturbance	14	11	1	1
Dysphoria	12	9	0	0
Headache	8	6	0	0
Nausea	5	4	0	0
Disorientation	3	2	0	0
Depersonalization	2	2	1	1

Incidence of Adverse Reactions in Active-Controlled Studies
	Nabilone (n=250)		Prochlorperazine (n=232)
Adverse Event	Patients	Percent	Patients	Percent
Drowsiness	165	66	108	47
Vertigo/Dizziness	147	59	53	23
Euphoria	95	38	12	5
Dry Mouth	54	22	11	5
Depression	35	14	37	16
Ataxia	32	13	4	2
Visual Disturbance	32	13	9	4
Concentration Difficulties	31	12	3	1
Hypotension	20	8	3	1
Asthenia	19	8	10	4
Anorexia	19	8	22	9
Headache	18	7	14	6
Sedation	7	3	2	1
Increased Appetite	6	2	2	1

Adverse Reactions by Body System—The following list of adverse events is organized by decreasing frequency within body systems for patients treated with Cesamet in controlled clinical trials. All events are listed regardless of causality assessment.

Blood and Hematopoietic—Anemia

Cardiovascular—Orthostatic hypotension, hypotension, tachycardia, syncope, palpitation, flushing, hypertension, arrhythmia, and cerebral vascular accident.

Eye and Ear—Vision disturbance, ear tightness, eye irritation, eye dryness, equilibrium dysfunction, tinnitus, eye disorder, amblyopia, eye swelling, eyelid diseases, pupil dilation, photophobia, and visual field defect.

Gastrointestinal—Dry mouth, nausea, anorexia, vomiting, diarrhea, abdominal pain, constipation, aphthous ulcer, mouth irritation, gastritis, and dyspepsia.

Genitourinary—Increased urination, decreased urination, hot flashes, urinary retention, and frequency of micturition.

Infection—Bacterial infection

Metabolic and Endocrine—Thirst

Musculoskeletal—Muscle pain, back pain, neck pain, joint pain, and unspecified pain.

Nervous System—Drowsiness, vertigo, ataxia, decreased concentration, sedation, hallucinations, paresthesia, tremor, memory disturbance, perception disturbance, convulsions, dystonia, numbness, and akathisia.

Psychiatric—Euphoria (feeling “high”), sleep disturbance, depression, confusion, disorientation, anxiety, depersonalization syndrome, speech disorder, abnormal dreams, insomnia, mood swings, inebriated feeling, toxic psychosis, paranoia, apathy, thought disorder, withdrawal, panic disorder, phobic neurosis, emotional disorder, and hyperactivity.

Respiratory—Dyspnea, pharyngitis, nasal congestion, sinus headache, thick tongue, dry throat, dry nose, wheezing, nosebleed, cough, voice change, and chest pain.

Skin and Appendages—Anhidrosis, photosensitivity, pruritus, rash, and allergic reactions.

Miscellaneous and Ill-Defined Conditions—Headache, fatigue, lightheadedness, coordination disturbance, asthesia, dysphoria, dizziness, taste change, excessive appetite, chills, excessive sweating, nervousness, malaise, postural dizziness, twitch, irritability, fever, inhibited walking, unconsciousness, hypotonia, and impaired urination.

Postmarketing Adverse Reactions—Cesamet has been marketed internationally since 1982. The following adverse reactions listed in order of decreasing frequency by body system have been reported since Cesamet has been marketed. All events are listed regardless of causality assessment.

Blood and Hematopoietic—Leukopenia

Cardiovascular—Hypotension and tachycardia

Eye and Ear—Visual disturbances

Gastrointestinal—Dry mouth, nausea, vomiting, and constipation

Nervous System—Hallucinations, CNS depression, CNS stimulation, ataxia, stupor, vertigo, convulsion, and circumoral paresthesia

Psychiatric—Somnolence, confusion, euphoria, depression, dysphoria, depersonalization, anxiety, psychosis, and emotional lability

Miscellaneous and Ill-Defined Conditions—Dizziness, headache, insomnia, abnormal thinking, chest pain, lack of effect, and face edema

Drug Abuse and Dependence

Controlled Substance—Cesamet, a synthetic cannabinoid pharmacologically related to Cannabis sativa L. (Marijuana; (delta-9-THC) is a highly abusable substance. Cesamet is controlled under Schedule II (CII) of the Controlled Substances Act. Prescriptions for Cesamet should be limited to the amount necessary for a single cycle of chemotherapy (i.e., a few days). Cesamet may produce subjective side effects which may be interpreted as a euphoria or marijuana-like "high" at therapeutic doses.

It is not known what proportion of individuals exposed chronically to Cesamet or other cannabinoids will develop either psychological or physical dependence. Long term use of these compounds has, however, been associated with disorders of motivation, judgment, and cognition. It is not clear, though, if this is a manifestation of the underlying personalities of chronic users of this class of drugs or if cannabinoids are directly responsible for these effects. An abstinence syndrome has been reported following discontinuation of delta-9-THC at high doses of 200 mg per day for 12 to 16 consecutive days. The acute phase was characterized by psychic distress, insomnia, and signs of autonomic hyperactivity (sweating, rhinorrhea, loose stools, hiccups). A protracted abstinence phase may have occurred in subjects who reported sleep disturbances for several weeks after delta-9-THC discontinuation.

Abuse—Cesamet may produce subjective side effects that may be interpreted as a euphoria or marijuana-like "high" at therapeutic doses. Cesamet was shown to be qualitatively and quantitatively similar to delta-9-THC in the production of cannabis-like effects, thus demonstrating that Cesamet has a high potential for abuse.

Preclinical studies performed in both dogs and monkeys demonstrated that Cesamet was cannabinoid-like. As with delta-9-THC, tolerance develops rapidly to the pharmacological effects in both the dog and the monkey. Cross-tolerance between Cesamet and delta-9-THC was demonstrated in the monkey.

Dependence—The physical dependence capacity of Cesamet is unknown at this time. Patients who participated in clinical trials of up to 5 days' duration evidenced no withdrawal symptoms on cessation of dosing.

Overdosage

Signs and Symptoms—Signs and symptoms of overdosage are an extension of the psychotomimetic and physiologic effects of Cesamet.

Treatment—To obtain up-to-date information about the treatment of overdose, a good resource is your certified Regional Poison Control Center. Telephone numbers of certified poison control centers are listed in the Physicians' Desk Reference (PDR). In managing overdosage, consider the possibility of multiple drug overdoses, interaction among drugs, and unusual drug kinetics in your patient.

Overdosage may be considered to have occurred, even at prescribed dosages, if disturbing psychiatric symptoms are present. In these cases, the patient should be observed in a quiet environment and supportive measures, including reassurance, should be used. Subsequent doses should be withheld until patients have returned to their baseline mental status; routine dosing may then be resumed if clinically indicated. In such instances, a lower initiating dose is suggested. In controlled clinical trials, alterations in mental status related to the use of Cesamet resolved within 72 hours without specific medical therapy.

In overdose settings, attention should be paid to vital signs, since both hypertension and hypotension have been known to occur; tachycardia and orthostatic hypotension were most commonly reported.

No cases of overdosage with more than 10 mg/day of nabilone were reported during clinical trials. Signs and symptoms that would be expected to occur in large overdose situations are psychotic episodes, including hallucinations, anxiety reactions, respiratory depression, and coma.

If psychotic episodes occur, the patient should be managed conservatively, if possible. For moderate psychotic episodes and anxiety reactions, verbal support and comforting may be sufficient. In more severe cases, antipsychotic drugs may be useful; however, the utility of antipsychotic drugs in cannabinoid psychosis has not been systematically evaluated. Support for their use is drawn from limited experience using antipsychotic agents to manage cannabis overdoses. Because of the potential for drug-drug interactions (e.g., additive CNS depressant effects due to nabilone and chlorpromazine), such patients should be closely monitored.

Protect the patient's airway and support ventilation and perfusion. Meticulously monitor and maintain, within acceptable limits, the patient's vital signs, blood gases, serum electrolytes, as well as other laboratory values and physical assessments. Absorption of drugs from the gastrointestinal tract may be decreased by giving activated charcoal, which, in many cases, is more effective than emesis or lavage; consider charcoal instead of or in addition to gastric emptying. Repeated doses of charcoal over time may hasten elimination of some drugs that have been absorbed. Safeguard the patient's airway when employing gastric emptying or charcoal.

The use of forced diuresis, peritoneal dialysis, hemodialysis, charcoal hemoperfusion, or cholestyramine has not been reported. In the presence of normal renal function, most of a dose of nabilone is eliminated through the biliary system.

Treatment for respiratory depression and comatose state consists in symptomatic and supportive therapy. Particular attention should be paid to the occurrence of hypothermia. If the patient becomes hypotensive, consider fluids, inotropes, and/or vasopressors.

The estimated oral median lethal dose in female mice is between 1,000 and 2,000 mg/kg; in the female rat, it is greater than 2,000 mg/kg, (See CLINICAL PHARMACOLOGY).

Cesamet Dosage and Administration

The usual adult dosage is 1 or 2 mg 2 times a day. On the day of chemotherapy, the initial dose should be given 1 to 3 hours before the chemotherapeutic agent is administered. To minimize side effects, it is recommended that the lower starting dose be used and that the dose be increased as necessary. A dose of 1 or 2 mg the night before may be useful. The maximum recommended daily dose is 6 mg given in divided doses 3 times a day.

Cesamet may be administered 2 or 3 times a day during the entire course of each cycle of chemotherapy and, if needed, for 48 hours after the last dose of each cycle of chemotherapy.

How is Cesamet Supplied

Cesamet® capsules (blue and white): 1 mg (bottles of 50 capsules) NDC 0037-1221-50. Capsules are imprinted with MEDA on the blue cap and a four-digit code (1221) on the white body. Store at controlled room temperature, 25°C (77°F); excursions permitted to 15-30°C (59-86°F) [see USP Controlled Room Temperature].

Rx Only

To report SUSPECTED ADVERSE REACTIONS, contact Meda Pharmaceuticals Inc. at 1-800-526-3840 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Revised: March 2010

Part No. 12-1352-001

Manufactured by:

Valeant Canada Ltd., Quebec, Canada

For:

Meda Pharmaceuticals®

Meda Pharmaceuticals Inc.

Somerset, New Jersey 08873-4120

©2009 Meda Pharmaceuticals Inc.

Made in Canada

Cesamet® is a trademark of Valeant Pharmaceuticals North America.

Package Label - Principal Display Panel – 50-Count Bottle Label

NDC 0037-1221-50

Rx Only

Cesamet® CII

(Nabilone Capsules)

1 mg

Each capsule contains 1 mg nabilone


50 Capsules

Meda Pharmaceuticals®


7013186-001

Rev. 12/09

Cesamet® is a registered trademark of

Valeant Pharmaceuticals North America.

Usual Dosage: 1 or 2 mg twice a day.

The maximum recommended daily dose

is 6 mg given in divided doses three times

a day. See package insert for dosage information.

Store at controlled room temperature

25°C (77°F). Excursions permitted

to 15°C-30°C (59°-86°F). [See USP

Controlled Room Temperature]

Mfd by: Valeant Canada Ltd., Quebec, Canada

For: Meda Pharmaceuticals®

Meda Pharmaceuticals Inc.

Somerset, NJ 08873-4120

Made in Canada

Package Label - Principal Display Panel – 50-Count Carton

NDC 0037-1221-50

Rx Only


Cesamet® CII

(Nabilone Capsules)


1 mg


Each capsule

contains1 mg

nabilone


50 Capsules


Meda Pharmaceuticals®

Cesamet   nabilone  capsule

Product Information Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 0037-1221 Route of Administration ORAL DEA Schedule CII

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength NABILONE (NABILONE) NABILONE 1 mg

Inactive Ingredients Ingredient Name Strength No Inactive Ingredients Found

Product Characteristics Color BLUE (Imprint is MEDA on blue side of capsule) , WHITE (Imprint is 1221 on white side of capsule) Score no score Shape CAPSULE Size 18mm Flavor Imprint Code MEDA;1221 Contains

Packaging # NDC Package Description Multilevel Packaging 1 0037-1221-50 1 BOTTLE In 1 CARTON contains a BOTTLE 1 50 CAPSULE In 1 BOTTLE This package is contained within the CARTON (0037-1221-50)

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
NDA	NDA018677	03/01/2010

Labeler - Meda Pharmaceuticals Inc. (051229602)

Revised: 05/2010Meda Pharmaceuticals Inc.

More Cesamet resources

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

• Cesamet Monograph (AHFS DI)


• Cesamet Consumer Overview


• Cesamet Advanced Consumer (Micromedex) - Includes Dosage Information


• Cesamet MedFacts Consumer Leaflet (Wolters Kluwer)


• Nabilone Professional Patient Advice (Wolters Kluwer)

Compare Cesamet with other medications

• Nausea/Vomiting, Chemotherapy Induced

Alcoholic Gastritis Medications

There are currently no drugs listed for "Alcoholic Gastritis".

Learn more about Alcoholic Gastritis

Micromedex Care Notes:

• Gastritis

Medical Encyclopedia:

• Gastritis

Drug List:

Boots Pharmacy Heartburn 10mg Tablets

Boots Pharmacy Heartburn 10 mg Tablets

(Omeprazole)

Read all of this leaflet carefully because it contains important information for you.

This medicine is available without prescription to treat minor conditions. However, you still need to take it carefully to get the best results from it.

• Keep this leaflet, you may need to read it again


• Ask your pharmacist if you need more information or advice

What this medicine is for

This medicine contains Omeprazole which belongs to a group of medicines called proton pump inhibitors, which act to reduce the amount of acid in your stomach.

It can be used to relieve acid reflux and heartburn, but it will not provide immediate relief of symptoms.

Before you take this medicine

This medicine can be taken by adults aged 18 years and over. However, some people should not take this medicine or should seek the advice of their pharmacist or doctor first.

Do not take:

• 
  If you are allergic to any of the ingredients


• 
  If you are under 18 years old
  


• 
  If you have an intolerance to some sugars, unless your doctor tells you to (this medicine contains lactose)


• 
  If you are pregnant or breastfeeding
  

Talk to your doctor:

• If you have had to take indigestion or heartburn medicine continuously for 4 weeks or more, to control your symptoms


• If you have long term recurrent symptoms of indigestion or heartburn


• If you are 45 years old or over and this is the first time you have had these symptoms, or your symptoms have recently changed


• If you have lost weight without trying, are frequently tired or run down


• If you have a bleeding stomach (you may be sick and it contains blood or dark particles that look like coffee grounds, pass blood in your stools or pass black tarry stools)


• If you have a lump in your stomach


• If you have stomach pain, pain on swallowing, difficulty in swallowing


• If you are persistently being sick


• If you have had a stomach ulcer or surgery


• If you have jaundice, or any other liver or kidney problems


• If you are due to have an endoscopy or a breath test called a C-urea test

Talk to your pharmacist or doctor:

• If you are 45 years old or over and taking any non-prescription (over the counter) medicines for indigestion or heartburn on a regular basis

Other important information

Driving and using machines: On rare occasions this medicine may cause drowsiness. You should not drive or operate machinery until you are sure you are not affected.

This medicine reduces the amount of acid that your stomach produces, and can upset the bacteria that live in your stomach. This may make you more susceptible to food poisoning.

If you have any blood tests tell the doctor you are taking these tablets.

If you take other medicines

Before you take these tablets, make sure that you tell your pharmacist about ANY other medicines you might be using at the same time, particularly the following:

• Other medicines to reduce stomach acid production (e.g. cimetidine, famotidine, ranitidine or lansoprazole)


• Diazepam (for your nerves), phenytoin (for epilepsy), warfarin (a blood thinner)


• Ketoconazole, itraconazole or voriconazole (for fungal infections)


• Digoxin (for heart problems)


• Cilostazol (for leg pain)


• Tacrolimus (to reduce the effect of the immune system)

If you are unsure about interactions with any other medicines, talk to your pharmacist. This includes medicines prescribed by your doctor and medicine you have bought for yourself, including herbal and homeopathic remedies.

How to take this medicine

Check the foil is not broken before use. If it is, do not take that tablet.

Adults aged 18 years and over: Take two capsules once a day, before meals

If your symptoms improve, reduce the number of tablets to one tablet a day. Increase to two tablets a day if your symptoms return.

You should always take the lowest amount that controls your symptoms.

Swallow the tablets whole with a drink of water or fruit juice. Do not crush or chew the tablets.

Do not give to children or adolescents under 18 years.

Do not take more than the amount recommended.

If symptoms do not improve within 2 weeks talk to your doctor.

If you require continuous treatment for more than 4 weeks to relieve your symptoms, talk to your doctor.

If your symptoms reappear shortly after you stop taking these tablets, talk to your doctor.

If you take too many tablets: Talk to a doctor straight away. Take your medicine and this leaflet with you.

Possible side effects

Most people will not have problems, but some may get some.

If you get any of these serious side effects, stop taking the tablets.

See a doctor at once:

• Difficulty in breathing, swelling of the face, neck, tongue or throat (severe allergic reactions)

These other effects are less serious. If they bother you talk to a pharmacist:

• Muscle or joint pain


• Confusion, agitation, depression, hallucinations


• Feeling sick, being sick, diarrhoea, constipation, wind, stomach pain


• Headache, dizziness, light headedness, feeling faint, vertigo, pins and needles


• Drowsiness, difficulty in sleeping


• Skin rash, itchy or lumpy skin (hives)


• Rarely, a rash when going into the sun (photosensitivity), hair loss, dry mouth, thrush


• Unusual bruising, or infections such as sore throats – this may be a sign of very rare changes in the blood


• Very rarely, blurred vision, taste disturbances, aggression, swelling of the hands and feet, low blood sodium levels, sweating, breast enlargement in men, impotence, general discomfort, fever, brain disease in patients with liver problems, kidney problems, increase in liver enzymes, inflammation of the liver with or without yellowing of the skin (jaundice), liver failure

If any side effect becomes severe, or you notice any side effect not listed here, please tell your pharmacist or doctor.

How to store this medicine

Do not store above 30°C. Store in the original package.

Keep this medicine in a safe place out of the sight and reach of children, preferably in a locked cupboard.

Use by the date on the end flap of the carton.

What is in this medicine

Each gastro-resistant coated tablet contains Omeprazole 10 mg, which is the active ingredient.

As well as the active ingredient, the tablets also contain lactose monohydrate, sodium starch glycolate, sodium stearate, sodium stearyl furmarate, hypromellose acetate succinate, talc, triethyl citrate, menoethanolamine, sodium laurilsulfate, sepisperse AP-3527 (containing propylene glycol, titanium dioxide (E171), red iron oxide (E172), hypromellose, yellow iron oxide (E172)), carnauba wax.

The pack contains 14 brownish-pink, capsule-shaped film coated tablets.

Who makes this medicine

Manufactured for

Boots Pharmacy

Nottingham

NG2 3AA

by the Marketing Authorisation holder

Dexcel-Pharma Ltd

1 Cottesbrooke Park

Heartlands Business Park

Daventry Northamptonshire

NN11 8YL

Leaflet prepared November 2008

If you would like any further information about this medicine, please contact

The Boots Company PLC

Nottingham

NG2 3AA

Component code

Other formats

To request a copy of this leaflet in Braille, large print or audio please call, free of charge:

0800 198 5000 (UK only)

Please be ready to give the following information:

Product name: Boots Pharmacy Heartburn 10 mg Tablets

Reference number: 14017/0069

This is a service provided by the Royal National Institute of Blind People.

Exforge HCT

Pronunciation: am-LOE-di-peen/val-SAR-tan/HYE-droe-KLOR-oh-THYE-a-zide
Generic Name: Amlodipine/Valsartan/Hydrochlorothiazide
Brand Name: Exforge HCT

Exforge HCT may cause birth defects or fetal or newborn death if you take it while you are pregnant. If you think you may be pregnant, contact your doctor right away.

Exforge HCT is used for:

Treating high blood pressure. It may also be used for other conditions as determined by your doctor.

Exforge HCT is a calcium channel blocker, angiotensin II receptor blocker, and thiazide diuretic combination. It works by relaxing the blood vessels and helping the kidneys remove fluid from the body.

Do NOT use Exforge HCT if:

• you are allergic to any ingredient in Exforge HCT or to any other sulfonamide medicine (eg, sulfamethoxazole)


• you are pregnant


• you have severe liver problems, severe kidney problems, or you are unable to urinate


• you are taking dofetilide or ketanserin

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

Before using Exforge HCT:

Some medical conditions may interact with Exforge HCT. 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 a woman of childbearing age


• 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 angioedema (eg, swelling of the hands, face, lips, eyes, throat, or tongue; difficulty swallowing or breathing; hoarseness), including angioedema caused by treatment with another angiotensin II receptor blocker (eg, losartan) or an angiotensin-converting enzyme (ACE) inhibitor (eg, lisinopril)


• if you are dehydrated, have low blood volume, have swelling or fluid retention, are on a low-salt (sodium) diet, or have high or low blood electrolyte levels (eg, sodium, magnesium, potassium, calcium)


• if you have gallbladder, liver, or kidney problems; asthma; gout or high blood levels of uric acid; lupus; parathyroid gland problems; low blood pressure; blood vessel problems; heart problems (eg, heart failure, angina, narrowing of heart blood vessels), or high blood cholesterol or lipid levels


• if you have a history of a stroke, heart attack, or recent kidney transplant


• if you have diabetes, especially if you are also taking aliskiren


• if you are on dialysis, will be having surgery, or you have recently had nerve surgery


• if you are taking another medicine for blood pressure or heart problems


• if you have never taken another medicine for high blood pressure

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

• Dofetilide or ketanserin because the risk of irregular heartbeat may be increased


• Aliskiren, potassium-sparing diuretics (eg, amiloride, spironolactone, triamterene), or potassium supplements because the risk of high blood potassium levels may be increased


• ACE inhibitors (eg, ramipril) because the risk of kidney problems and high blood potassium levels may be increased


• Nonsteroidal anti-inflammatory drugs (NSAIDs) (eg, celecoxib, ibuprofen, naproxen) because they may decrease Exforge HCT's effectiveness and the risk of serious kidney problems may be increased


• Adrenocorticotropic hormone (ACTH), barbiturates (eg, phenobarbital), conivaptan, corticosteroids (eg, prednisone), cyclosporine, diuretics (eg, furosemide), itraconazole, ketoconazole, narcotic pain relievers (eg, morphine), HIV protease inhibitors (eg, ritonavir), rifampin, sildenafil, or other medicines for high blood pressure because they may increase the risk of Exforge HCT's side effects


• Aspirin, cholestyramine, or colestipol because they may decrease Exforge HCT's effectiveness


• Carbamazepine, diazoxide, digoxin, lithium, or simvastatin because the risk of their side effects and toxic effects may be increased by Exforge HCT


• Insulin or other diabetes medicines (eg, glipizide, metformin) because their effectiveness may be decreased by Exforge HCT

This may not be a complete list of all interactions that may occur. Ask your health care provider if Exforge HCT 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 Exforge HCT:

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

• An extra patient leaflet is available with Exforge HCT. Talk to your pharmacist if you have questions about this information.


• Take Exforge HCT by mouth with or without food.


• Exforge HCT may increase the amount of urine or cause you to urinate more often when you first start taking it. To keep this from disturbing your sleep, try to take your dose before 6 pm.


• If you take cholestyramine or colestipol, ask your doctor or pharmacist how to take it with Exforge HCT.


• Take Exforge HCT on a regular schedule to get the most benefit from it. Taking Exforge HCT at the same time each day will help you remember to take it.


• Continue to take Exforge HCT even if you feel well. Do not miss any doses.


• If you miss a dose of Exforge HCT, take 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 take 2 doses at once.

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

Important safety information:

• Exforge HCT may cause drowsiness, dizziness, or blurred vision. These effects may be worse if you take it with alcohol or certain medicines. Use Exforge HCT with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.


• Exforge HCT may cause dizziness, light-headedness, or fainting; alcohol, hot weather, exercise, or fever may increase these effects. To prevent them, sit up or stand slowly, especially in the morning. Sit or lie down at the first sign of any of these effects.


• It may take up to 2 weeks or more for Exforge HCT to work fully. Do not stop using Exforge HCT or change your dose of Exforge HCT without checking with your doctor.


• Exforge HCT contains hydrochlorothiazide, a sulfonamide, which can cause certain eye problems (myopia, angle-closure glaucoma). Your risk may be increased if you are allergic to sulfonamide medicines (eg, sulfamethoxazole) or to penicillin antibiotics (eg, amoxicillin). Untreated angle-closure glaucoma can lead to permanent vision loss. If these eye problems occur, symptoms usually occur within hours to weeks of starting Exforge HCT. Contact your doctor immediately if you experience symptoms such as vision changes (eg, decreased vision clearness) or eye pain.


• Patients who take medicine for high blood pressure often feel tired or run down for a few weeks after starting treatment. Be sure to take your medicine even if you may not feel "normal." Tell your doctor if you develop any new symptoms.


• Your doctor may also prescribe a potassium supplement for you. If so, take the potassium supplement exactly as prescribed. Do not start taking additional potassium on your own or change your diet to include more potassium without first checking with your doctor.


• Check with your doctor before you use a salt substitute or a product that has potassium in it.


• If vomiting, diarrhea, or excessive sweating occur, you will need to take care not to become dehydrated. This could increase your risk for low blood pressure. Contact your doctor for instructions.


• Exforge HCT may cause you to become sunburned more easily. Avoid the sun, sunlamps, or tanning booths until you know how you react to Exforge HCT. Use a sunscreen or wear protective clothing if you must be outside for more than a short time.


• Exforge HCT may raise your blood sugar. High blood sugar may make you feel confused, drowsy, or thirsty. It can also make you flush, breathe faster, or have a fruit-like breath odor. If these symptoms occur, tell your doctor right away.


• Diabetes patients - Check blood sugar levels closely. Ask your doctor before you change the dose of your diabetes medicine.


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


• Talk with your doctor or pharmacist about all of your blood pressure medicines and how to use them. Do not start, stop, or change the dose of any blood pressure medicine unless your doctor tells you to.


• Exforge HCT may interfere with certain lab tests, including parathyroid function. Be sure your doctor and lab personnel know you are taking Exforge HCT.


• Lab tests, including blood pressure, kidney function, and blood electrolyte levels, may be performed while you use Exforge HCT. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.


• Use Exforge HCT with caution in the ELDERLY; they may be more sensitive to its effects.


• Exforge HCT should be used with extreme caution in CHILDREN; safety and effectiveness in children have not been confirmed.


• PREGNANCY and BREAST-FEEDING: Exforge HCT may cause birth defects, or fetal or newborn death if you take it while you are pregnant. If you think you may be pregnant, contact your doctor right away. Exforge HCT is found breast milk. Do not breast-feed while taking Exforge HCT.

Possible side effects of Exforge HCT:

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:

Dizziness; headache; indigestion; light-headedness; mild back pain; muscle spasms; nausea; sore throat or discomfort when swallowing; stuffy nose; tiredness; upset stomach.

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); blurred vision or other vision changes (eg, decreased vision clearness); burning, numbness, or tingling; change in the amount of urine produced; chest pain; confusion; eye pain; fainting; fast or irregular heartbeat; fever, chills, or persistent sore throat; joint pain, swelling, warmth, or redness (especially of the big toe joint); mental or mood changes (eg, depression); numbness of an arm or leg; red, swollen, blistered, or peeling skin; restlessness; seizures; severe or persistent dizziness, drowsiness, or light-headedness; severe or persistent dry mouth; severe or persistent muscle pain, tenderness, or cramps; severe or persistent nausea, vomiting, or stomach or back pain; shortness of breath; sluggishness; sudden, severe headache; sudden, unexplained weight gain; swelling of the feet, ankles, or hands; symptoms of liver problems (eg, dark urine, loss of appetite, pale stools, severe or persistent stomach pain, yellowing of the eyes or skin); unusual bruising or bleeding; unusual thirst, tiredness, or weakness.

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: Exforge HCT 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 fainting; flushing; severe or persistent dizziness or light-headedness; symptoms of blood electrolyte problems (eg, confusion; irregular heartbeat; mental or mood changes; muscle pain, weakness, or cramping; seizures; sluggishness); symptoms of dehydration (eg, drowsiness; dry eyes; fast heartbeat; nausea; restlessness; unusual thirst, tiredness, or weakness; vomiting).

Proper storage of Exforge HCT:

Store Exforge HCT 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 Exforge HCT out of the reach of children and away from pets.

General information:

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


• Exforge HCT 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 Exforge HCT. 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

Copyright © 2012 Wolters Kluwer Health, Inc.

More Exforge HCT resources

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

• Exforge HCT Prescribing Information (FDA)


• Exforge HCT Advanced Consumer (Micromedex) - Includes Dosage Information


• Exforge HCT Consumer Overview

Compare Exforge HCT with other medications

• High Blood Pressure

Irbetan

Irbetan may be available in the countries listed below.

Ingredient matches for Irbetan

Irbesartan

Irbesartan is reported as an ingredient of Irbetan in the following countries:

• Japan

International Drug Name Search

cefoxitin Intravenous

sef-OX-i-tin

Commonly used brand name(s)

In the U.S.

• Mefoxin

Available Dosage Forms:

• Powder for Solution


• Solution

Therapeutic Class: Antibiotic

Pharmacologic Class: 2nd Generation Cephalosporin

Uses For cefoxitin

Cefoxitin injection is used to treat bacterial infections in many different parts of the body. cefoxitin is also given before certain types of surgery to prevent infections.

Cefoxitin injection belongs to the class of medicines known as cephalosporin antibiotics. It works by killing bacteria or preventing their growth. However, cefoxitin will not work for colds, flu, or other virus infections.

cefoxitin is available only with your doctor's prescription.

Before Using cefoxitin

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 cefoxitin, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to cefoxitin 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

Appropriate studies performed to date have not demonstrated pediatric-specific problems that would limit the usefulness of cefoxitin injection in children. However, safety and efficacy have not been established in children younger than 3 months old.

Geriatric

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of cefoxitin injection in the elderly. However, elderly patients are more likely to have age-related kidney problems, which may require caution and an adjustment in the dose for patients receiving cefoxitin injection.

Pregnancy

	Pregnancy Category	Explanation
All Trimesters	B	Animal studies have revealed no evidence of harm to the fetus, however, there are no adequate studies in pregnant women OR animal studies have shown an adverse effect, but adequate studies in pregnant women have failed to demonstrate a risk to the fetus.

Breast Feeding

Studies in women suggest that this medication poses minimal risk to the infant when used during 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. Tell your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.

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 cefoxitin. Make sure you tell your doctor if you have any other medical problems, especially:

• Colitis (inflammation in gut), history of or


• Diarrhea, severe, history of or


• Seizures—Use with caution. May make these conditions worse.

• Kidney disease—Use with caution. The effects may be increased because of slower removal of the medicine from the body.

Proper Use of cefoxitin

A nurse or other trained health professional will give you cefoxitin. cefoxitin is given through a needle placed in one of your veins.

Precautions While Using cefoxitin

If your symptoms or your child's symptoms do not improve within a few days, or if they become worse, check with your doctor.

Cefoxitin injection may cause diarrhea, and in some cases it can be severe. Do not take any medicine or give medicine to your child to treat diarrhea without first checking with your doctor. Diarrhea medicines may make the diarrhea worse or make it last longer. If you have any questions about this or if mild diarrhea continues or gets worse, check with your doctor.

Before you or your child have any medical tests, tell the medical doctor in charge that you are receiving cefoxitin. The results of some tests may be affected by cefoxitin.

cefoxitin 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:

More common

• Changes in skin color


• pain


• swelling of the foot or leg


• tenderness

Rare

• Agitation


• coma


• confusion


• decreased urine output


• depression


• dizziness


• headache


• hostility


• irritability


• lethargy


• muscle twitching


• nausea


• rapid weight gain


• seizures


• stupor


• swelling of the face, ankles, or hands


• unusual tiredness or weakness

Incidence not known

• Abdominal or stomach cramps or tenderness


• back, leg, or stomach pains


• bleeding and bruising


• bleeding gums


• blistering, peeling, or loosening of the skin


• bloating


• bloody or cloudy urine


• bloody, black, or tarry stools


• chest pain


• chills


• clay-colored stools


• cloudy urine


• cough


• coughing up blood


• cracks in the skin


• dark urine


• decrease in urine output or decrease in urine-concentrating ability


• diarrhea


• diarrhea, watery and severe, which may also be bloody


• difficult or labored breathing


• difficult or painful urination


• difficulty with breathing, chewing, swallowing, or talking


• dizziness


• double vision


• drooping eyelids


• fast heartbeat


• feeling of discomfort


• fever


• general body swelling


• greatly decreased frequency of urination or amount of urine


• headache


• high fever


• hives


• increased menstrual flow or vaginal bleeding


• increased thirst


• inflammation of the joints


• itching


• itching of the vagina or genital area


• joint or muscle pain


• large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs


• loss of appetite


• loss of heat from the body


• muscle aches


• muscle weakness


• nosebleeds


• pain during sexual intercourse


• pale skin


• paralysis


• prolonged bleeding from cuts


• puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue


• rash


• red or black, tarry stools


• red or dark brown urine


• red skin lesions, often with a purple center


• red, irritated eyes


• red, swollen skin


• scaly skin


• severe tiredness


• shortness of breath


• sore throat


• sores, ulcers, or white spots on the lips or in the mouth


• sudden decrease in the amount of urine


• swelling of the feet or lower legs


• swollen lymph glands


• swollen or painful glands


• thick, white vaginal discharge with no odor or with a mild odor


• tightness in the chest


• troubled breathing with exertion


• unexplained bleeding or bruising


• unpleasant breath odor


• unusual bleeding or bruising


• unusual weight loss


• vomiting


• vomiting of blood


• wheezing


• yellowing of the eyes or skin

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

• Red streaks on the skin


• swelling, tenderness, or pain at the injection site

Incidence not known

• Hives or welts


• redness of the skin

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: cefoxitin Intravenous 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 cefoxitin Intravenous resources

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

Compare cefoxitin Intravenous with other medications

• Aspiration Pneumonia
• Bone infection
• Cesarean Section
• Cholecystitis
• Deep Neck Infection
• Endometritis
• Gonococcal Infection, Uncomplicated
• Intraabdominal Infection
• Joint Infection
• Kidney Infections
• Pelvic Inflammatory Disease
• Peritonitis
• Pneumonia
• Septicemia
• Skin and Structure Infection
• Skin Infection
• Surgical Prophylaxis
• Urinary Tract Infection

Vaccines

Vaccines are a special preparation of antigenic material (live or inactivated) that are used to stimulate the development of antibodies, to produce immunity against a specific disease.

Vaccines can be produced by making bacteria and viruses nonpathogenic, under conditions that make them lose their virulence but not their antigenic nature. They won’t cause disease but are able to stimulate the immune system to produce antibodies against a particular organism.

See also

• bacterial vaccines
• toxoids
• viral vaccines

Drug List:

Imbys

Imbys may be available in the countries listed below.

Ingredient matches for Imbys

Azithromycin

Azithromycin is reported as an ingredient of Imbys in the following countries:

• Belize


• Costa Rica


• Dominican Republic


• El Salvador


• Guatemala


• Honduras


• Nicaragua


• Panama

International Drug Name Search

Zaditor

Generic Name: ketotifen (Ophthalmic route)

kee-toe-TYE-fen

Commonly used brand name(s)

In the U.S.

• Alaway


• Claritin Eye


• Zaditor


• Zyrtec Itchy Eye

Available Dosage Forms:

• Solution

Therapeutic Class: Ophthalmologic Agent

Pharmacologic Class: Mast Cell Stabilizer

Chemical Class: Piperidine

Uses For Zaditor

Ketotifen ophthalmic (eye) solution is used to temporarily prevent itching of the eye caused by a condition known as allergic conjunctivitis. It works by acting on certain cells, called mast cells, to prevent them from releasing substances that cause the allergic reaction.

This medicine is available both over-the-counter (OTC) and with your doctor's prescription.

Before Using Zaditor

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

Studies on this medicine have been done only in adult patients, and there is no specific information comparing use of ketotifen in children younger than 3 years of age with use in other age groups.

Geriatric

Many medicines have not been studied specifically in older people. Therefore, it may not be known whether they work exactly the same way they do in younger adults or if they cause different side effects or problems in older people. There is no specific information comparing use of ophthalmic ketotifen in the elderly with use in other age groups.

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

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. Tell your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.

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.

Proper Use of ketotifen

This section provides information on the proper use of a number of products that contain ketotifen. It may not be specific to Zaditor. Please read with care.

Do not wear contact lenses if your eyes are red . Also, do not use this medicine to treat irritation related to contact lens use. If you wear contact lenses: Take out your contact lenses before using ketotifen eye drops. Wait at least 10 minutes after putting the eye drops in before putting the contact lenses back in.

To use the eye drops:

• First, wash your hands. Tilt the head back and, pressing your finger gently on the skin just beneath the lower eyelid, pull the lower eyelid away from the eye to make a space. Drop the medicine into this space. Let go of the eyelid and gently close the eyes. Do not blink. Keep the eyes closed for 1 to 2 minutes to allow the medicine to be absorbed by the eye.


• If you think you did not get the drop of medicine into your eye properly, use another drop.


• To keep the medicine as germ-free as possible, do not touch the applicator tip to any surface (including the eye). Also, keep the container tightly closed.

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 ophthalmic dosage form (eye drops):
  
  • For prevention of itching of the eye due to allergic conjunctivitis (eye allergy):
    
    • Adults and children 3 years of age and older—Use one drop in each affected eye every 8 to 12 hours.
    
    
    • Children up to 3 years of age—Use and dose must be determined by your doctor.
    
    
  
  

Missed Dose

If you miss a dose of this medicine, take 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. Do not double doses.

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.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Precautions While Using Zaditor

If your symptoms do not improve or if your condition becomes worse, check with your doctor.

Zaditor 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:

More common

• Eye redness and swelling

Less common

• Eye discharge


• eye discomfort


• eye pain


• hives


• increased itching of eyes


• rash.

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

• Headaches


• stuffy or runny nose

Less common

• Burning or stinging of eyes


• dry eyes


• eyelid disorder


• eye sensitivity to light


• fever, tiredness, achiness, and sore throat


• increase in size of pupils


• sore throat


• tearing.

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: Zaditor 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 Zaditor resources

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

• Zaditor Prescribing Information (FDA)


• Zaditor Drops MedFacts Consumer Leaflet (Wolters Kluwer)


• Zaditor Concise Consumer Information (Cerner Multum)


• Zaditor Monograph (AHFS DI)


• Zyrtec Itchy Eye Prescribing Information (FDA)

Compare Zaditor with other medications

• Conjunctivitis, Allergic