Nimesulida Mepha may be available in the countries listed below.
Ingredient matches for Nimesulida Mepha
Nimesulide
Nimesulide is reported as an ingredient of Nimesulida Mepha in the following countries:
- Portugal
International Drug Name Search
Thursday, 29 September 2016
Vivitrol
Vivitrol® (naltrexone for extended-release injectable suspension) is supplied as a microsphere formulation of naltrexone for suspension, to be administered by intramuscular injection. Naltrexone is an opioid antagonist with little, if any, opioid agonist activity.
Naltrexone is designated chemically as morphinan-6-one, 17-(cyclopropylmethyl)-4,5-epoxy-3,14-dihydroxy-(5α) (CAS Registry # 16590-41-3). The molecular formula is C20H23NO4 and its molecular weight is 341.41 in the anhydrous form (i.e., < 1% maximum water content). The structural formula is:
Naltrexone base anhydrous is an off-white to a light tan powder with a melting point of 168-170º C (334-338º F). It is insoluble in water and is soluble in ethanol.
Vivitrol is provided as a carton containing a vial each of Vivitrol microspheres and diluent, one 5-mL syringe, one ½-inch 20-gauge preparation needle, and two 1½-inch 20-gauge administration needles with safety device.
Vivitrol microspheres consist of a sterile, off-white to light tan powder that is available in a dosage strength of 380-mg naltrexone per vial. Naltrexone is incorporated in 75:25 polylactide-co-glycolide (PLG) at a concentration of 337 mg of naltrexone per gram of microspheres.
The diluent is a clear, colorless solution. The composition of the diluent includes carboxymethylcellulose sodium salt, polysorbate 20, sodium chloride, and water for injection. The microspheres must be suspended in the diluent prior to injection.
CLINICAL PHARMACOLOGY:
Pharmacodynamics
Mechanism of Action
Naltrexone is an opioid antagonist with highest affinity for the mu opioid receptor. Naltrexone has few, if any, intrinsic actions besides its opioid blocking properties. However, it does produce some pupillary constriction, by an unknown mechanism.
The administration of Vivitrol is not associated with the development of tolerance or dependence. In subjects physically dependent on opioids, Vivitrol will precipitate withdrawal symptomatology.
Occupation of opioid receptors by naltrexone may block the effects of endogenous opioid peptides. The neurobiological mechanisms responsible for the reduction in alcohol consumption observed in alcohol-dependent patients treated with naltrexone are not entirely understood. However, involvement of the endogenous opioid system is suggested by preclinical data.
Naltrexone blocks the effects of opioids by competitive binding at opioid receptors. This makes the blockade produced potentially surmountable, but overcoming full naltrexone blockade by administration of opioids may result in non-opioid receptor-mediated symptoms such as histamine release.
Vivitrol is not aversive therapy and does not cause a disulfiram-like reaction either as a result of opiate use or ethanol ingestion.
Pharmacokinetics
Absorption
Vivitrol is an extended-release, microsphere formulation of naltrexone designed to be administered by intramuscular (IM) gluteal injection every 4 weeks or once a month. After IM injection, the naltrexone plasma concentration time profile is characterized by a transient initial peak, which occurs approximately 2 hours after injection, followed by a second peak observed approximately 2 - 3 days later. Beginning approximately 14 days after dosing, concentrations slowly decline, with measurable levels for greater than 1 month.
Maximum plasma concentration (Cmax) and area under the curve (AUC) for naltrexone and 6β-naltrexol (the major metabolite) following Vivitrol administration are dose proportional. Compared to daily oral dosing with naltrexone 50 mg over 28 days, total naltrexone exposure is 3 to 4-fold higher following administration of a single dose of Vivitrol 380 mg. Steady state is reached at the end of the dosing interval following the first injection. There is minimal accumulation (<15%) of naltrexone or 6β-naltrexol upon repeat administration of Vivitrol.
Distribution
In vitro data demonstrate that naltrexone plasma protein binding is low (21%).
Metabolism
Naltrexone is extensively metabolized in humans. Production of the primary metabolite, 6β-naltrexol, is mediated by dihydrodiol dehydrogenase, a cytosolic family of enzymes. The cytochrome P450 system is not involved in naltrexone metabolism. Two other minor metabolites are 2-hydroxy-3-methoxy-6β-naltrexol and 2-hydroxy-3-methoxy-naltrexone. Naltrexone and its metabolites are also conjugated to form glucuronide products.
Significantly less 6β-naltrexol is generated following IM administration of Vivitrol compared to administration of oral naltrexone due to a reduction in first-pass hepatic metabolism.
Elimination
Elimination of naltrexone and its metabolites occurs primarily via urine, with minimal excretion of unchanged naltrexone.
The elimination half life of naltrexone following Vivitrol administration is 5 to 10 days and is dependent on the erosion of the polymer. The elimination half life of 6β-naltrexol following Vivitrol administration is 5 to 10 days.
Special Populations
Hepatic Impairment: The pharmacokinetics of Vivitrol are not altered in subjects with mild to moderate hepatic impairment (Groups A and B of the Child-Pugh classification). Dose adjustment is not required in subjects with mild or moderate hepatic impairment. Vivitrol pharmacokinetics were not evaluated in subjects with severe hepatic impairment (see PRECAUTIONS).
Renal Impairment: A population pharmacokinetic analysis indicated mild renal insufficiency (creatinine clearance of 50-80 mL/min) had little or no influence on Vivitrol pharmacokinetics and that no dosage adjustment is necessary (see PRECAUTIONS). Vivitrol pharmacokinetics have not been evaluated in subjects with moderate and severe renal insufficiency (see PRECAUTIONS).
Gender: In a study in healthy subjects (n=18 females and 18 males), gender did not influence the pharmacokinetics of Vivitrol.
Age: The pharmacokinetics of Vivitrol have not been evaluated in the geriatric population.
Race: The effect of race on the pharmacokinetics of Vivitrol has not been studied.
Pediatrics: The pharmacokinetics of Vivitrol have not been evaluated in a pediatric population.
Drug-Drug Interactions
Clinical drug interaction studies with Vivitrol have not been performed.
Naltrexone antagonizes the effects of opioid-containing medicines, such as cough and cold remedies, antidiarrheal preparations and opioid analgesics (see PRECAUTIONS).
CLINICAL STUDIES:
The efficacy of Vivitrol in the treatment of alcohol dependence was evaluated in a 24-week, placebo-controlled, multi-center, double-blind, randomized trial of alcohol dependent (DSM-IV criteria) outpatients. Subjects were treated with an injection every 4 weeks of Vivitrol 190 mg, Vivitrol 380 mg or placebo. Oral naltrexone was not administered prior to the initial or subsequent injections of study medication. Psychosocial support was provided to all subjects in addition to medication.
Subjects treated with Vivitrol 380 mg demonstrated a greater reduction in days of heavy drinking than those treated with placebo. Heavy drinking was defined as self-report of 5 or more standard drinks consumed on a given day for male patients and 4 or more drinks for female patients. Among the subset of patients (n=53, 8% of the total study population) who abstained completely from drinking during the week prior to the first dose of medication, compared with placebo-treated patients, those treated with Vivitrol 380 mg had greater reductions in the number of drinking days and the number of heavy drinking days. In this subset, patients treated with Vivitrol were also more likely than placebo-treated patients to maintain complete abstinence throughout treatment. The same treatment effects were not evident among the subset of patients (n=571, 92% of the total study population) who were actively drinking at the time of treatment initiation.
INDICATIONS AND USAGE:
Vivitrol is indicated for the treatment of alcohol dependence in patients who are able to abstain from alcohol in an outpatient setting prior to initiation of treatment with Vivitrol.
Patients should not be actively drinking at the time of initial Vivitrol administration.
Treatment with Vivitrol should be part of a comprehensive management program that includes psychosocial support.
CONTRAINDICATIONS:
Vivitrol is contraindicated in:
- Patients receiving opioid analgesics (see PRECAUTIONS).
- Patients with current physiologic opioid dependence (see WARNINGS).
- Patients in acute opiate withdrawal (see WARNINGS).
- Any individual who has failed the naloxone challenge test or has a positive urine screen for opioids.
- Patients who have previously exhibited hypersensitivity to naltrexone, PLG, carboxymethylcellulose, or any other components of the diluent.
WARNINGS:
Hepatotoxicity
Naltrexone has the capacity to cause hepatocellular injury when given in excessive doses.
Naltrexone is contraindicated in acute hepatitis or liver failure, and its use in patients with active liver disease must be carefully considered in light of its hepatotoxic effects.
The margin of separation between the apparently safe dose of naltrexone and the dose causing hepatic injury appears to be only five-fold or less. Vivitrol does not appear to be a hepatotoxin at the recommended doses.
Patients should be warned of the risk of hepatic injury and advised to seek medical attention if they experience symptoms of acute hepatitis. Use of Vivitrol should be discontinued in the event of symptoms and/or signs of acute hepatitis.
Eosinophilic pneumonia
In clinical trials with Vivitrol, there was one diagnosed case and one suspected case of eosinophilic pneumonia. Both cases required hospitalization, and resolved after treatment with antibiotics and corticosteroids. Should a person receiving Vivitrol develop progressive dyspnea and hypoxemia, the diagnosis of eosinophilic pneumonia should be considered (see ADVERSE REACTIONS). Patients should be warned of the risk of eosinophilic pneumonia, and advised to seek medical attention should they develop symptoms of pneumonia. Clinicians should consider the possibility of eosinophilic pneumonia in patients who do not respond to antibiotics.
Unintended Precipitation of Opioid Withdrawal
To prevent occurrence of an acute abstinence syndrome (withdrawal) in patients dependent on opioids, or exacerbation of a pre-existing subclinical abstinence syndrome, patients must be opioid-free for a minimum of 7-10 days before starting Vivitrol treatment. Since the absence of an opioid drug in the urine is often not sufficient proof that a patient is opioid-free, a naloxone challenge test should be employed if the prescribing physician feels there is a risk of precipitating a withdrawal reaction following administration of Vivitrol.
Opioid Overdose Following an Attempt to Overcome Opiate Blockade
Vivitrol is not indicated for the purpose of opioid blockade or the treatment of opiate dependence. Although Vivitrol is a potent antagonist with a prolonged pharmacological effect, the blockade produced by Vivitrol is surmountable. This poses a potential risk to individuals who attempt, on their own, to overcome the blockade by administering large amounts of exogenous opioids. Indeed, any attempt by a patient to overcome the antagonism by taking opioids is very dangerous and may lead to fatal overdose. Injury may arise because the plasma concentration of exogenous opioids attained immediately following their acute administration may be sufficient to overcome the competitive receptor blockade. As a consequence, the patient may be in immediate danger of suffering life-endangering opioid intoxication (e.g., respiratory arrest, circulatory collapse). Patients should be told of the serious consequences of trying to overcome the opioid blockade (see INFORMATION FOR PATIENTS).
There is also the possibility that a patient who had been treated with Vivitrol will respond to lower doses of opioids than previously used. This could result in potentially life-threatening opioid intoxication (respiratory compromise or arrest, circulatory collapse, etc.). Patients should be aware that they may be more sensitive to lower doses of opioids after Vivitrol treatment is discontinued (see INFORMATION FOR PATIENTS).
PRECAUTIONS:
General
When Reversal of Vivitrol Blockade Is Required for Pain Management
In an emergency situation in patients receiving Vivitrol, a suggested plan for pain management is regional analgesia, conscious sedation with a benzodiazepine, and use of non-opioid analgesics or general anesthesia.
In a situation requiring opioid analgesia, the amount of opioid required may be greater than usual, and the resulting respiratory depression may be deeper and more prolonged.
A rapidly acting opioid analgesic which minimizes the duration of respiratory depression is preferred. The amount of analgesic administered should be titrated to the needs of the patient. Non-receptor mediated actions may occur and should be expected (e.g., facial swelling, itching, generalized erythema, or bronchoconstriction), presumably due to histamine release.
Irrespective of the drug chosen to reverse Vivitrol blockade, the patient should be monitored closely by appropriately trained personnel in a setting equipped and staffed for cardiopulmonary resuscitation.
Depression and Suicidality
In controlled clinical trials of Vivitrol, adverse events of a suicidal nature (suicidal ideation, suicide attempts, completed suicides) were infrequent overall, but were more common in patients treated with Vivitrol than in patients treated with placebo (1% vs. 0). In some cases, the suicidal thoughts or behavior occurred after study discontinuation, but were in the context of an episode of depression which began while the patient was on study drug. Two completed suicides occurred, both involving patients treated with Vivitrol.
Depression-related events associated with premature discontinuation of study drug were also more common in patients treated with Vivitrol (~1%) than in placebo-treated patients (0).
In the 24-week, placebo-controlled pivotal trial, adverse events involving depressed mood were reported by 10% of patients treated with Vivitrol 380 mg, as compared to 5% of patients treated with placebo injections.
Alcohol dependent patients, including those taking Vivitrol, should be monitored for the development of depression or suicidal thinking. Families and caregivers of patients being treated with Vivitrol should be alerted to the need to monitor patients for the emergence of symptoms of depression or suicidality, and to report such symptoms to the patient’s healthcare provider.
Injection Site Reactions
Vivitrol injections may be followed by pain, tenderness, induration, swelling, erythema or pruritus. In the clinical trials, one patient developed an area of induration that continued to enlarge after 4 weeks, with subsequent development of necrotic tissue that required surgical excision. Additional cases of injection site reaction with features including abscess, sterile abscess, induration, and necrosis, some of which resulted in surgical intervention, have been reported during postmarketing surveillance. Patients should be informed that any concerning injection site reactions should be brought to the attention of the physician (see INFORMATION FOR PATIENTS).
Renal Impairment
Vivitrol pharmacokinetics have not been evaluated in subjects with moderate and severe renal insufficiency. Because naltrexone and its primary metabolite are excreted primarily in the urine, caution is recommended in administering Vivitrol to patients with moderate to severe renal impairment.
Alcohol Withdrawal
Use of Vivitrol does not eliminate nor diminish alcohol withdrawal symptoms.
Intramuscular injections
As with any intramuscular injection, Vivitrol should be administered with caution to patients with thrombocytopenia or any coagulation disorder (e.g., hemophilia and severe hepatic failure).
Information for Patients
Physicians should discuss the following issues with patients for whom they prescribe Vivitrol:
- Patients should be advised to carry documentation to alert medical personnel to the fact that they are taking Vivitrol (naltrexone for extended-release injectable suspension). This will help to ensure that the patients obtain adequate medical treatment in an emergency.
- Patients should be advised that administration of large doses of heroin or any other opioid while on Vivitrol may lead to serious injury, coma, or death.
- Patients should be advised that because Vivitrol can block the effects of opiates and opiate-like drugs, patients will not perceive any effect if they attempt to self-administer heroin or any other opioid drug in small doses while on Vivitrol. Also, patients on Vivitrol may not experience the same effects from opioid containing analgesic, antidiarrheal, or antitussive medications.
- Patients should be advised that if they previously used opioids, they may be more sensitive to lower doses of opioids after Vivitrol treatment is discontinued.
- Patients should be advised that Vivitrol may cause liver injury in people who develop liver disease from other causes. Patients should immediately notify their physician if they develop symptoms and/or signs of liver disease.
- Patients should be advised that Vivitrol may cause an allergic pneumonia. Patients should immediately notify their physician if they develop signs and symptoms of pneumonia, including dyspnea, coughing or wheezing.
- Patients should be advised that a reaction at the site of Vivitrol injection may occur. Reactions include pain, tenderness, induration, swelling, erythema, and pruritus. Rarely, serious injection site reactions may occur. Patients should be advised to seek medical attention for worsening skin reactions, particularly if the reaction does not improve one month following the injection.
- Patients should be advised that they may experience nausea following the initial injection of Vivitrol. These episodes of nausea tend to be mild and subside within a few days post-injection. Patients are less likely to experience nausea in subsequent injections.
- Patients should be advised that because Vivitrol is an intramuscular injection and not an implanted device, once Vivitrol is injected, it is not possible to remove it from the body.
- Patients should be advised that Vivitrol has been shown to treat alcohol dependence only when used as part of a treatment program that includes counseling and support.
- Patients should be advised to notify their physician if they:
- become pregnant or intend to become pregnant during treatment with Vivitrol.
- are breast-feeding.
- experience respiratory symptoms such as dyspnea, coughing, or wheezing when taking Vivitrol.
- experience significant pain or redness at the site of injection, particularly if the reaction does not improve one month following the injection.
- experience other unusual or significant side effects while on Vivitrol therapy.
- become pregnant or intend to become pregnant during treatment with Vivitrol.
Drug Interactions
Patients taking Vivitrol may not benefit from opioid-containing medicines (see PRECAUTIONS, Pain Management).
Because naltrexone is not a substrate for CYP drug metabolizing enzymes, inducers or inhibitors of these enzymes are unlikely to change the clearance of Vivitrol. No clinical drug interaction studies have been performed with Vivitrol to evaluate drug interactions, therefore prescribers should weigh the risks and benefits of concomitant drug use.
The safety profile of patients treated with Vivitrol concomitantly with antidepressants was similar to that of patients taking Vivitrol without antidepressants.
Carcinogenesis, mutagenesis, impairment of fertility
Carcinogenicity studies have not been conducted with Vivitrol.
Carcinogenicity studies of oral naltrexone hydrochloride (administered via the diet) have been conducted in rats and mice. In rats, there were small increases in the numbers of testicular mesotheliomas in males and tumors of vascular origin in males and females. The clinical significance of these findings is not known.
Naltrexone was negative in the following in vitro genotoxicity studies: bacterial reverse mutation assay (Ames test), the heritable translocation assay, CHO cell sister chromatid exchange assay, and the mouse lymphoma gene mutation assay. Naltrexone was also negative in an in vivo mouse micronucleus assay. In contrast, naltrexone tested positive in the following assays: Drosophila recessive lethal frequency assay, non-specific DNA damage in repair tests with E. coli and WI-38 cells, and urinalysis for methylated histidine residues.
Naltrexone given orally caused a significant increase in pseudopregnancy and a decrease in pregnancy rates in rats at 100 mg/kg/day (600 mg/m2/day). There was no effect on male fertility at this dose level. The relevance of these observations to human fertility is not known.
Pregnancy Category C
Reproduction and developmental studies have not been conducted for Vivitrol. Studies with naltrexone administered via the oral route have been conducted in pregnant rats and rabbits.
Teratogenic Effects: Oral naltrexone has been shown to increase the incidence of early fetal loss in rats administered ≥ 30 mg/kg/day (180 mg/m2/day) and rabbits administered ≥ 60 mg/kg/day (720 mg/m2/day).
There are no adequate and well-controlled studies of either naltrexone or Vivitrol in pregnant women. Vivitrol should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.
Labor and Delivery
The potential effect of Vivitrol on duration of labor and delivery in humans is unknown.
Nursing Mothers
Transfer of naltrexone and 6β-naltrexol into human milk has been reported with oral naltrexone. Because of the potential for tumorigenicity shown for naltrexone in animal studies, and because of the potential for serious adverse reactions in nursing infants from Vivitrol, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.
Pediatric Use
The safety and efficacy of Vivitrol have not been established in the pediatric population.
Geriatric Use
In trials of alcohol dependent subjects, 2.6% (n=26) of subjects were >65 years of age, and one patient was >75 years of age. Clinical studies of Vivitrol did not include sufficient numbers of subjects age 65 and over to determine whether they respond differently from younger subjects.
ADVERSE REACTIONS
In all controlled and uncontrolled trials during the premarketing development of Vivitrol, more than 900 patients with alcohol and/or opioid dependence have been treated with Vivitrol. Approximately 400 patients have been treated for 6 months or more, and 230 for 1 year or longer.
Adverse Events Leading to Discontinuation of Treatment
In controlled trials of 6 months or less, 9% of patients treated with Vivitrol discontinued treatment due to an adverse event, as compared to 7% of the patients treated with placebo. Adverse events in the Vivitrol 380-mg group that led to more dropouts were injection site reactions (3%), nausea (2%), pregnancy (1%), headache (1%), and suicide-related events (0.3%). In the placebo group, 1% of patients withdrew due to injection site reactions, and 0% of patients withdrew due to the other adverse events.
Common Adverse Events
The table lists all adverse events, regardless of causality, occurring in ≥5% of patients with alcohol dependence, for which the incidence was greater in the combined Vivitrol group than in the placebo group. A majority of patients treated with Vivitrol in clinical studies had adverse events with a maximum intensity of “mild” or “moderate.”
Post-marketing Reports
Reports From Other Intramuscular Drug Products Containing Polylactide-co-glycolide (PLG) Microspheres – Not With Vivitrol
Retinal Artery Occlusion
Retinal artery occlusion after injection with another drug product containing polylactide-co-glycolide (PLG) microspheres has been reported very rarely during post-marketing surveillance. This event has been reported in the presence of abnormal arteriovenous anastomosis. No cases of retinal artery occlusion have been reported during Vivitrol clinical trials or post-marketing surveillance. Vivitrol should be administered by intramuscular (IM) injection into the gluteal muscle, and care must be taken to avoid inadvertent injection into a blood vessel (see DOSAGE AND ADMINISTRATION).
| Body system | Adverse Event/Preferred Term | Placebo | Naltrexone for extended-release injectable suspension | ||||||||
| N = 214 | 400 mg N = 25 | 380 mg N = 205 | 190 mg N = 210 | All N = 440 | |||||||
| N | % | N | % | N | % | N | % | N | % | ||
| Gastrointestinal disorders | Nausea | 24 | 11 | 8 | 32 | 68 | 33 | 53 | 25 | 129 | 29 |
| Vomiting NOS | 12 | 6 | 3 | 12 | 28 | 14 | 22 | 10 | 53 | 12 | |
| Diarrhea1 | 21 | 10 | 3 | 12 | 27 | 13 | 27 | 13 | 57 | 13 | |
| Abdominal pain2 | 17 | 8 | 4 | 16 | 23 | 11 | 23 | 11 | 50 | 11 | |
| Dry mouth | 9 | 4 | 6 | 24 | 10 | 5 | 8 | 4 | 24 | 5 | |
| Infections and infestations | Upper respiratory tract infection–Other3 | 28 | 13 | 0 | 0 | 27 | 13 | 25 | 12 | 52 | 12 |
| Pharyngitis4 | 23 | 11 | 0 | 0 | 22 | 11 | 35 | 17 | 57 | 13 | |
| Psychiatric disorders | Insomnia, sleep disorder | 25 | 12 | 2 | 8 | 29 | 14 | 27 | 13 | 58 | 13 |
| Anxiety5 | 17 | 8 | 2 | 8 | 24 | 12 | 16 | 8 | 42 | 10 | |
| Depression | 9 | 4 | 0 | 0 | 17 | 8 | 7 | 3 | 24 | 5 | |
| General disorders and administration site conditions | Any ISR | 106 | 50 | 22 | 88 | 142 | 69 | 121 | 58 | 285 | 65 |
| Injection site tenderness | 83 | 39 | 18 | 72 | 92 | 45 | 89 | 42 | 199 | 45 | |
| Injection site induration | 18 | 8 | 7 | 28 | 71 | 35 | 52 | 25 | 130 | 30 | |
| Injection site pain | 16 | 7 | 0 | 0 | 34 | 17 | 22 | 10 | 56 | 13 | |
| Other ISR (primarily nodules, swelling) | 8 | 4 | 8 | 32 | 30 | 15 | 16 | 8 | 54 | 12 | |
| Injection site pruritus | 0 | 0 | 0 | 0 | 21 | 10 | 13 | 6 | 34 | 8 | |
| Injection site ecchymosis | 11 | 5 | 0 | 0 | 14 | 7 | 9 | 4 | 23 | 5 | |
| Asthenic conditions6 | 26 | 12 | 3 | 12 | 47 | 23 | 40 | 19 | 90 | 20 | |
| Musculoskeletal and connective tissue disorders | Arthralgia, arthritis, joint stiffness | 11 | 5 | 1 | 4 | 24 | 12 | 12 | 6 | 37 | 9 |
| Back pain, back stiffness | 10 | 5 | 1 | 4 | 12 | 6 | 14 | 7 | 27 | 6 | |
| Muscle cramps7 | 3 | 1 | 0 | 0 | 16 | 8 | 5 | 2 | 21 | 5 | |
| Skin and subcutaneous tissue disorders | Rash8 | 8 | 4 | 3 | 12 | 12 | 6 | 10 | 5 | 25 | 6 |
| Nervous system disorders | Headache9 | 39 | 18 | 9 | 36 | 51 | 25 | 34 | 16 | 94 | 21 |
| Dizziness, syncope | 9 | 4 | 4 | 16 | 27 | 13 | 27 | 13 | 58 | 13 | |
| Somnolence, sedation | 2 | 1 | 3 | 12 | 8 | 4 | 9 | 4 | 20 | 5 | |
| Metabolism and nutrition disorders | Anorexia, appetite decreased NOS, appetite disorder NOS | 6 | 3 | 5 | 20 | 30 | 14 | 13 | 6 | 48 | 11 |
1 Includes the preferred terms: diarrhea NOS; frequent bowel movements; gastrointestinal upset; loose stools
2 Includes the preferred terms: abdominal pain NOS; abdominal pain upper; stomach discomfort; abdominal pain lower
3 Includes the preferred terms: upper respiratory tract infection NOS; laryngitis NOS; sinusitis NOS
4 Includes the preferred terms: nasopharyngitis; pharyngitis streptococcal; pharyngitis NOS
5 Includes the preferred terms: anxiety NEC; anxiety aggravated; agitation; obsessive compulsive disorder; panic attack; nervousness; post-traumatic stress
6 Includes the preferred terms: malaise; fatigue (these two comprise the majority of cases); lethargy; sluggishness
7 Includes the preferred terms: muscle cramps; spasms; tightness; twitching; stiffness; rigidity
8 Includes the preferred terms: rash NOS; rash papular; heat rash
9 Includes the preferred terms: headache NOS; sinus headache; migraine; frequent headaches
Laboratory Tests
In clinical trials, subjects on Vivitrol had increases in eosinophil counts relative to subjects on placebo. With continued use of Vivitrol, eosinophil counts returned to normal over a period of several months.
Vivitrol 380-mg was associated with a decrease in platelet count. Patients treated with high dose Vivitrol experienced a mean maximal decrease in platelet count of 17.8 x 103/µL, compared to 2.6 x 103/µL in placebo patients. In randomized controlled trials, Vivitrol was not associated with an increase in bleeding related adverse events.
In short-term, controlled trials, the incidence of AST elevations associated with Vivitrol treatment was similar to that observed with oral naltrexone treatment (1.5% each) and slightly higher than observed with placebo treatment (0.9%).
In short-term controlled trials, more patients treated with Vivitrol 380 mg (11%) and oral naltrexone (17%) shifted from normal creatinine phosphokinase (CPK) levels before treatment to abnormal CPK levels at the end of the trials, compared to placebo patients (8%). In open-label trials, 16% of patients dosed for more than 6 months had increases in CPK. For both the oral naltrexone and Vivitrol 380-mg groups, CPK abnormalities were most frequently in the range of 1-2 x ULN. However, there were reports of CPK abnormalities as high as 4x ULN for the oral naltrexone group, and 35 x ULN for the Vivitrol 380-mg group. Overall, there were no differences between the placebo and naltrexone (oral or injectable) groups with respect to the proportions of patients with a CPK value at least three times the upper limit of normal. No factors other than naltrexone exposure were associated with the CPK elevations.
Vivitrol may be cross-reactive with certain immunoassay methods for the detection of drugs of abuse (specifically opioids) in urine. For further information, reference to the specific immunoassay instructions is recommended.
Other Events Observed During the Premarketing Evaluation of Vivitrol
The following is a list of preferred terms that reflect events reported by alcohol and/or opiate dependent subjects treated with Vivitrol in controlled trials. The listing does not include those events already listed in the previous tables or elsewhere in labeling, those events for which a drug cause was remote, those events which were so general as to be uninformative, and those events reported only once which did not have a substantial probability of being acutely life-threatening.
Gastrointestinal Disorders – constipation, toothache, flatulence, gastroesophageal reflux disease, hemorrhoids, colitis, gastrointestinal hemorrhage, paralytic ileus, perirectal abscess
Infections and Infestations – influenza, bronchitis, urinary tract infection, gastroenteritis, tooth abscess, pneumonia, cellulitis
General Disorders and Administration Site Conditions – pyrexia, lethargy, rigors, chest pain, chest tightness, weight decreased
Psychiatric Disorders – irritability, libido decreased, abnormal dreams, alcohol withdrawal syndrome, agitation, euphoric mood, delirium
Nervous System Disorders – dysgeusia, disturbance in attention, migraine, mental impairment, convulsions, ischemic stroke, cerebral arterial aneurysm
Musculoskeletal and Connective Tissue Disorders – pain in limb, muscle spasms, joint stiffness
Skin and Subcutaneous Tissue Disorders – sweating increased, night sweats, pruritus
Respiratory, Thoracic, and Mediastinal Disorders – pharyngolaryngeal pain, dyspnea, sinus congestion, chronic obstructive airways disease
Metabolism and Nutrition Disorders – appetite increased, heat exhaustion, dehydration, hypercholesterolemia
Vascular Disorders – hypertension, hot flushes, deep venous thrombosis, pulmonary embolism
Eye Disorders – conjunctivitis
Blood and Lymphatic System Disorders – lymphadenopathy (including cervical adenitis), white blood cell count increased
Cardiac Disorders – palpitations, atrial fibrillation, myocardial infarction, angina pectoris, angina unstable, cardiac failure congestive, coronary artery atherosclerosis
Immune System Disorders – seasonal allergy, hypersensitivity reaction (including angioneurotic edema and urticaria)
Pregnancy, Puerperium, and Perinatal Conditions – abortion missed
Hepatobiliary Disorders – cholelithiasis, aspartate aminotransferase increased, alanine aminotransferase increased, cholecystitis acute
DRUG ABUSE AND DEPENDENCE:
Controlled Substance Class
Vivitrol is not a controlled substance.
Physical and Psychological Dependence
Naltrexone, the active ingredient in Vivitrol, is a pure opioid antagonist that does not lead to physical or psychological dependence. Tolerance to the opioid antagonist effect is not known to occur.
OVERDOSAGE:
There is limited experience with overdose of Vivitrol. Single doses up to 784 mg were administered to 5 healthy subjects. There were no serious or severe adverse events. The most common effects were injection site reactions, nausea, abdominal pain, somnolence, and dizziness. There were no significant increases in hepatic enzymes.
In the event of an overdose, appropriate supportive treatment should be initiated.
DOSAGE AND ADMINISTRATION:
Vivitrol must be administered by a health care professional.
The recommended dose of Vivitrol is 380 mg delivered intramuscularly every 4 weeks or once a month. The injection should be administered by a health care professional as an intramuscular (IM) gluteal injection, alternating buttocks, using the carton components provided (see HOW SUPPLIED). Vivitrol must not be administered intravenously.
If a patient misses a dose, he/she should be instructed to receive the next dose as soon as possible.
Pretreatment with oral naltrexone is not required before using Vivitrol.
Reinitiation of Treatment in Patients Previously Discontinued
There are no data to specifically address reinitiation of treatment.
Switching From Oral Naltrexone for Alcohol Dependence
There are no systematically collected data that specifically address the switch from oral naltrexone to Vivitrol.
Preparation of Dose
Vivitrol must be suspended only in the diluent supplied in the carton and must be administered with the needle supplied in the carton. All components (i.e., the microspheres, diluent, preparation needle, and an administration needle with safety device) are required for administration. A spare administration needle is provided in case of clogging. Do not substitute any other components for the components of the carton.
HOW SUPPLIED:
Vivitrol (naltrexone for extended-release injectable suspension) is supplied in single use cartons. Each carton contains one 380 mg vial of Vivitrol microspheres, one vial containing 4 mL (to deliver 3.4 mL) Diluent for the suspension of Vivitrol, one 5-mL prepackaged syringe, one 20-gauge ½-inch needle, and two 20-gauge 1½-inch needles with safety device: NDC 63459-300-42.
Storage and Handling
The entire dose pack should be stored in the refrigerator (2 - 8ºC, 36 - 46ºF). Unrefrigerated, Vivitrol can be stored at temperatures not exceeding 25ºC (77ºF) for no more than 7 days prior to administration. Do not expose the product to temperatures above 25ºC (77ºF). Vivitrol should not be frozen.
Parenteral products should be visually inspected for particulate matter and discoloration prior to administration whenever solution and container permit. A properly mixed
Serobif
Serobif may be available in the countries listed below.
Ingredient matches for Serobif
Interferon beta
Interferon beta is reported as an ingredient of Serobif in the following countries:
- Italy
International Drug Name Search
Wednesday, 28 September 2016
Amisulpride Ratiopharm
Amisulpride Ratiopharm may be available in the countries listed below.
Ingredient matches for Amisulpride Ratiopharm
Amisulpride
Amisulpride is reported as an ingredient of Amisulpride Ratiopharm in the following countries:
- France
- Slovakia
International Drug Name Search
Motretinide
Scheme
Rec.INN
ATC (Anatomical Therapeutic Chemical Classification)
D10AD05
CAS registry number (Chemical Abstracts Service)
0056281-36-8
Chemical Formula
C23-H31-N-O2
Molecular Weight
353
Therapeutic Category
Dermatological agent: Keratolytic
Chemical Name
2,4,6,8-Nonatetraenamide, N-ethyl-9-(4-methoxy-2,3,6-trimethylphenyl)-3,7-dimethyl-, (all-E)-
Foreign Names
- Motretinidum (Latin)
- Motretinid (German)
- Motrétinide (French)
- Motretinida (Spanish)
Generic Names
- Motretinide (OS: USAN)
- Motrétinide (OS: DCF)
- Ro 11-1430 (IS)
Brand Name
- Tasmaderm
Gebro, Switzerland
International Drug Name Search
Glossary
| DCF | Dénomination Commune Française |
| IS | Inofficial Synonym |
| OS | Official Synonym |
| Rec.INN | Recommended International Nonproprietary Name (World Health Organization) |
| USAN | United States Adopted Name |
Click for further information on drug naming conventions and International Nonproprietary Names.
Pädiacrom
Pädiacrom may be available in the countries listed below.
Ingredient matches for Pädiacrom
Cromoglicic Acid
Cromoglicic Acid disodium salt (a derivative of Cromoglicic Acid) is reported as an ingredient of Pädiacrom in the following countries:
- Germany
International Drug Name Search
Sulfatiazolo
Sulfatiazolo may be available in the countries listed below.
Ingredient matches for Sulfatiazolo
Sulfathiazole
Sulfatiazolo (DCIT) is also known as Sulfathiazole (Rec.INN)
International Drug Name Search
Glossary
| DCIT | Denominazione Comune Italiana |
| Rec.INN | Recommended International Nonproprietary Name (World Health Organization) |
Click for further information on drug naming conventions and International Nonproprietary Names.
Matil
Matil may be available in the countries listed below.
Ingredient matches for Matil
Amisulpride
Amisulpride is reported as an ingredient of Matil in the following countries:
- Greece
International Drug Name Search
Tuesday, 27 September 2016
Tetra Sanbe
Tetra Sanbe may be available in the countries listed below.
Ingredient matches for Tetra Sanbe
Tetracycline
Tetracycline hydrochloride (a derivative of Tetracycline) is reported as an ingredient of Tetra Sanbe in the following countries:
- Indonesia
International Drug Name Search
Vitussin Expectorant
Generic Name: guaifenesin and hydrocodone (gwye FEN e sin and HYE droe KOE done)
Brand Names: A-Cof DH, Canges-XP, Codiclear DH, Condasin, Cotuss V, Execlear, Extendryl HC, Hycotuss Expectorant, Hydrocod-GF, Kwelcof, Monte-G HC, Narcof, Pancof XP, Pneumotussin 2.5, Relasin-HCX, Touro HC, Tussicle, Tusso-DF, Vi-Q-Tuss, Vitussin Expectorant, Xpect-HC, Z-Cof HCX
What is Vitussin Expectorant (guaifenesin and hydrocodone)?
Guaifenesin is an expectorant. It helps loosen congestion in your chest and throat, making it easier to cough out through your mouth.
Hydrocodone is a narcotic cough suppressant.
Guaifenesin and hydrocodone is used to treat cough and reduce chest congestion caused by the common cold, flu, or allergies.
Guaifenesin and hydrocodone may also be used for purposes not listed in this medication guide.
What is the most important information I should know about Vitussin Expectorant (guaifenesin and hydrocodone)?
This medication may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be alert. Drinking alcohol can increase certain side effects of guaifenesin and hydrocodone. Tell your doctor if you regularly use other medicines that make you sleepy (such as other cold or allergy medicine, narcotic pain medicine, sleeping pills, muscle relaxers, and medicine for seizures, depression, or anxiety). They can add to sleepiness caused by guaifenesin and hydrocodone. Hydrocodone may be habit-forming and should be used only by the person it was prescribed for. Keep the medication in a secure place where others cannot get to it.
What should I discuss with my healthcare provider before taking Vitussin Expectorant (guaifenesin and hydrocodone)?
Hydrocodone may be habit forming and should be used only by the person it was prescribed for. Never share this medication with another person, especially someone with a history of drug abuse or addiction. Keep the medication in a place where others cannot get to it. Do not use this medicine if you are allergic to hydrocodone or guaifenesin.
To make sure you can safely take guaifenesin and hydrocodone, tell your doctor if you have any of these other conditions:
liver or kidney disease;
asthma;
urination problems;
an enlarged prostate;
a thyroid disorder;
seizures or epilepsy;
gallbladder disease;
a head injury; or
Addison's disease.
FDA pregnancy category C. It is not known whether this medication will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant. Guaifenesin and hydrocodone can pass into breast milk and may harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby.
How should I take Vitussin Expectorant (guaifenesin and hydrocodone)?
Take exactly as prescribed by your doctor. Do not take in larger or smaller amounts or for longer than recommended. Follow the directions on your prescription label.
Guaifenesin and hydrocodone can be taken with or without food.
Measure liquid medicine with a special dose-measuring spoon or cup, not a regular table spoon. If you do not have a dose-measuring device, ask your pharmacist for one.
Call your doctor if your symptoms do not improve, or if they get worse. Store at room temperature away from moisture and heat.
Keep track of the amount of medicine used from each new bottle. Guaifenesin and hydrocodone is a drug of abuse and you should be aware if anyone is using your medicine improperly or without a prescription.
What happens if I miss a dose?
Take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.
What happens if I overdose?
Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.
Overdose symptoms may include extreme drowsiness, sweating, pinpoint pupils, nausea, vomiting, dry mouth, confusion, cold and clammy skin, muscle weakness, fainting, weak pulse, slow heart rate, seizure (convulsions), weak or shallow breathing, or breathing that stops.
What should I avoid while taking Vitussin Expectorant (guaifenesin and hydrocodone)?
This medication may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be alert. Drinking alcohol can increase certain side effects of guaifenesin and hydrocodone.
Ask a doctor or pharmacist before using any other cough, cold, allergy, pain, or sleep medicine. Guaifenesin is contained in many combination medicines. Taking certain products together can cause you to get too much guaifenesin. Check the label to see if a medicine contains guaifenesin.
Vitussin Expectorant (guaifenesin and hydrocodone) side effects
Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat. Stop using this medication and call your doctor at once if you have a serious side effect such as:
slow heart rate, weak or shallow breathing;
feeling like you might pass out;
confusion, fear, unusual thoughts or behavior;
seizure (convulsions); or
urinating less than usual or not at all.
Less serious side effects may include:
dizziness, drowsiness;
nausea, vomiting, upset stomach;
blurred vision;
constipation;
dry mouth; or
sweating.
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
What other drugs will affect Vitussin Expectorant (guaifenesin and hydrocodone)?
Tell your doctor if you regularly use other medicines that make you sleepy (such as other cold or allergy medicine, narcotic pain medicine, sleeping pills, muscle relaxers, and medicine for seizures, depression, or anxiety). They can add to sleepiness caused by guaifenesin and hydrocodone.
Tell your doctor about all other medicines you use, especially:
antidepressants such as amitriptyline (Elavil, Vanatrip, Limbitrol), doxepin (Sinequan), nortriptyline (Pamelor), and others;
atropine (Donnatal, and others), benztropine (Cogentin), dimenhydrinate (Dramamine), glycopyrrolate (Robinul), mepenzolate (Cantil), methscopolamine (Pamine), or scopolamine (Transderm-Scop);
bladder or urinary medications such as darifenacin (Enablex), flavoxate (Urispas), oxybutynin (Ditropan, Oxytrol), tolterodine (Detrol), or solifenacin (Vesicare);
a bronchodilator such as ipratropium (Atrovent) or tiotropium (Spiriva); or
irritable bowel medications such as dicyclomine (Bentyl), hyoscyamine (Anaspaz, Cystospaz, Levsin, and others), or propantheline (Pro-Banthine).
This list is not complete and other drugs may interact with guaifenesin and hydrocodone. Tell your doctor about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal products. Do not start a new medication without telling your doctor.
More Vitussin Expectorant resources
- Vitussin Expectorant Side Effects (in more detail)
- Vitussin Expectorant Use in Pregnancy & Breastfeeding
- Vitussin Expectorant Drug Interactions
- Vitussin Expectorant Support Group
- 0 Reviews for Vitussin Expectorant - Add your own review/rating
- CodiCLEAR DH Liquid MedFacts Consumer Leaflet (Wolters Kluwer)
- Entuss Liquid MedFacts Consumer Leaflet (Wolters Kluwer)
- Tusso-HC Sustained-Release Tablets MedFacts Consumer Leaflet (Wolters Kluwer)
Compare Vitussin Expectorant with other medications
- Cough
Where can I get more information?
- Your pharmacist can provide more information about guaifenesin and hydrocodone.
See also: Vitussin Expectorant side effects (in more detail)
Tamsulosina Tosicina
Tamsulosina Tosicina may be available in the countries listed below.
Ingredient matches for Tamsulosina Tosicina
Tamsulosin
Tamsulosin hydrochloride (a derivative of Tamsulosin) is reported as an ingredient of Tamsulosina Tosicina in the following countries:
- Spain
International Drug Name Search
Medazepam Q
Medazepam Q may be available in the countries listed below.
Ingredient matches for Medazepam Q
Medazepam
Medazepam is reported as an ingredient of Medazepam Q in the following countries:
- Hungary
International Drug Name Search
Xionil
Xionil may be available in the countries listed below.
Ingredient matches for Xionil
Bromazepam
Bromazepam is reported as an ingredient of Xionil in the following countries:
- Bangladesh
International Drug Name Search
Unguentum Neomycini
Unguentum Neomycini may be available in the countries listed below.
Ingredient matches for Unguentum Neomycini
Neomycin
Neomycin sulfate (a derivative of Neomycin) is reported as an ingredient of Unguentum Neomycini in the following countries:
- Poland
International Drug Name Search
Realdiron
Realdiron may be available in the countries listed below.
Ingredient matches for Realdiron
Interferon alfa
Interferon alfa Interferon alfa-2b (Arg-23; His-34) (a derivative of Interferon alfa) is reported as an ingredient of Realdiron in the following countries:
- Bulgaria
- Latvia
- Lithuania
- Serbia
International Drug Name Search
Monday, 26 September 2016
Fluoxetina Cinfa
Fluoxetina Cinfa may be available in the countries listed below.
Ingredient matches for Fluoxetina Cinfa
Fluoxetine
Fluoxetine hydrochloride (a derivative of Fluoxetine) is reported as an ingredient of Fluoxetina Cinfa in the following countries:
- Portugal
- Spain
International Drug Name Search
Calcio Cloruro Bioindustria Lim
Calcio Cloruro Bioindustria Lim may be available in the countries listed below.
Ingredient matches for Calcio Cloruro Bioindustria Lim
Calcium Chloride
Calcium Chloride dihydrate (a derivative of Calcium Chloride) is reported as an ingredient of Calcio Cloruro Bioindustria Lim in the following countries:
- Italy
International Drug Name Search
Omeprazol Winthrop
Omeprazol Winthrop may be available in the countries listed below.
Ingredient matches for Omeprazol Winthrop
Omeprazole
Omeprazole is reported as an ingredient of Omeprazol Winthrop in the following countries:
- Portugal
- Spain
International Drug Name Search
Ceftazidime Mylan Enfants et Nourrissons
Ceftazidime Mylan Enfants et Nourrissons may be available in the countries listed below.
Ingredient matches for Ceftazidime Mylan Enfants et Nourrissons
Ceftazidime
Ceftazidime pentahydrate (a derivative of Ceftazidime) is reported as an ingredient of Ceftazidime Mylan Enfants et Nourrissons in the following countries:
- France
International Drug Name Search
Klallergine
Klallergine may be available in the countries listed below.
Ingredient matches for Klallergine
Loratadine
Loratadine is reported as an ingredient of Klallergine in the following countries:
- Russian Federation
International Drug Name Search
AlleRx Dose Pack PE
phenylephrine hydrochloride, chlorpheniramine maleate, and methscopolamine nitrate
Dosage Form: tablets
AlleRx® DOSE PACK PE
AM Dose - 40 mg phenylephrine HCI and 2.5 mg methscopolamine nitrate
PM Dose - 10 mg phenylephrine HCI, 8 mg chlorpheniramine maleate and 2.5 mg methscopolamine nitrate
AlleRx® DOSE PACK PE 30
AM Dose - 40 mg phenylephrine HCI and 2.5 mg methscopolamine nitrate
PM Dose - 10 mg phenylephrine HCI, 8 mg chlorpheniramine maleate and 2.5 mg methscopolamine nitrate
DESCRIPTION
| Each AM tablet contains: | Each PM tablet contains: |
| Phenylephrine HCl ................ 40 mg | Phenylephrine HCl ....................10 mg |
| Methscopolamine Nitrate ..... 2.5 mg | Chlorpheniramine Maleate .......8 mg |
| Methscopolamine Nitrate .........2.5 mg |
Phenylephrine hydrochloride is a decongestant having the chemical name (-)-m-Hydroxy-α-[(methyl amino)methyl] benzyl alcohol hydrochloride.
Chlorpheniramine maleate is an antihistamine having the chemical name 2-pyridinepropanamine, gamma-(4 chlorophenyl)-N, N-dimethyl-, (Z)-2-butenedioate (1:1).
Methscopolamine nitrate is an anticholinergic having the chemical name 3-oxa-9-azoniatricyclo [3.3.1.0 2, 4] nonane, 7-(3-hydroxy-1-oxo-2-phenylpropoxy)-9, 9-dimethyl-, nitrate, [7(S)-(1α, 2β, 4β, 5α, 7β)]; C 17H21NO4•CH3NO3, MW = 80.4.
Inactive Ingredients:
AM tablets: Each orange AM tablet contains Hypromellose, Dicalcium Phosphate, Talc, Magnesium Stearate, Stearic Acid, D&C Red #30 and D&C Yellow #10.
PM tablets: Each blue PM tablet contains Hypromellose, Dicalcium Phosphate, Talc, FD&C Blue # 1, Stearic Acid and Magnesium Stearate.
CLINICAL PHARMACOLOGY
Phenylephrine HCl is a sympathomimetic amine which acts on the alpha adrenergic receptors. Clinically, phenylephrine shrinks swollen mucous membranes, reduces tissue hyperemia, edema, and nasal congestion, and increases nasal airway patency.
Chlorpheniramine maleate is an alkylamine-type antihistamine. This group of antihistamines is among the most active histamine antagonists and is generally effective in relatively low doses.
Methscopolamine nitrate is a quaternary ammonium derivative of the anticholinergic scopolamine which possesses the peripheral actions of the belladonna alkaloids, but does not exhibit the central actions because of its lack of ability to cross the blood-brain barrier. Its antimuscarinic effect causes inhibition of salivary secretions, reduction in volume and total acid content of gastric secretion, and inhibition of gastrointestinal motility. It is poorly and unreliably absorbed. Drug effects appear in about one hour and persist for about 4 to 6 hours. It is excreted primarily in the urine and bile, or as unabsorbed drug in feces.
INDICATIONS AND USAGE
For the temporary relief of symptoms associated with allergic rhinitis.
CONTRAINDICATIONS
This product is contraindicated in patients with hypersensitivity to phenylephrine HCl, methscopolamine nitrate, and chlorpheniramine maleate. AlleRx® PE is contraindicated in patients with severe hypertension, severe coronary artery disease, patients on monoamine oxidase inhibitor (MAOI) therapy or within 14 days of stopping monoamine oxidase inhibitor (MAOI) therapy, and in nursing mothers. AlleRx PE is also contraindicated in patients with narrow-angle glaucoma, urinary retention, peptic ulcer, and during an asthmatic attack.
WARNINGS
Sympathomimetic amines should be used cautiously in patients with hypertension, diabetes mellitus, ischemic heart disease, hyperthyroidism, increased intraocular pressure, and prostatic hypertrophy. Sympathomimetics may produce central nervous system stimulation with convulsions or cardiovascular collapse with accompanying hypotension. The elderly (60 years or older) are more likely to exhibit adverse reactions. Antihistamines may cause excitability, especially in children. At dosages higher than the recommended dose, nervousness, dizziness, or sleeplessness may occur. Do not exceed recommended dosage.
Methscopolamine nitrate may produce drowsiness or blurred vision. The patient should be cautioned regarding activities requiring mental alertness such as operating a motor vehicle or performing hazardous work while taking AlleRx PE.
Co-administration of sildenafil citrate and other organic nitrates has been shown to potentiate the hypotension effects of nitrates. Co-administration of AlleRx PE and sildenafil citrate has not been studied. Therefore, the use of sildenafil citrate and AlleRx PE together is not recommended.
PRECAUTIONS
General: AlleRx PE should be used with caution in patients with diabetes mellitus, cardiovascular disease, and hyperactivity to sympathomimetic amines. Hypertensive patients should only use with medical advice, as they may experience a change in blood pressure due to added vasoconstriction. Antihistamines may cause drowsiness, and ambulatory patients who operate machinery or motor vehicles should be cautioned accordingly. Methscopolamine nitrate should be used with caution in the elderly and all patients with autonomic neuropathy, hepatic or renal disease, or ulcerative colitis.
Drug Interactions: Monoamine oxidase (MAO) inhibitors and beta-adrenergic blockers increase the effects of sympathomimetic amines. Sympathomimetic amines may reduce the antihypertensive effects of methyldopa, guanethidine, mecamylamine, reserpine and veratrum alkaloids. Additive anticholinergic effects may result from concomitant use with antipsychotics, tricyclic antidepressants, and other drugs with anticholinergic effects. Concomitant administration with antacids may interfere with the absorption of methscopolamine nitrate.
Carcinogenesis, Mutagenesis, Impairment of Fertility: Animal studies to assess the long-term carcinogenic and mutagenic potential or the effect on fertility in animals or humans have not been performed.
Pregnancy Category C: It is not known whether AlleRx can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. AlleRx should be given to a pregnant woman only if clearly needed.
Nursing Mothers: It is not known whether this combination drug is excreted in human milk. However, phenylephrine HCl administered alone distributes into the breast milk of lactating human females; therefore, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.
Pediatric Use: The safety and effectiveness in children under 12 years of age have not been established.
Geriatric Use: The elderly (60 years and older) are more likely to experience adverse reactions to sympathomimetics. Overdosage of sympathomimetics in this age group may cause hallucinations, convulsions, CNS depression, and/or death. Demonstrate safe use of a short-acting sympathomimetic amine before use of an extended-action formulation.
Adverse Reactions
Adverse reactions include drowsiness, lassitude, nausea, giddiness, dryness of mouth, blurred vision, cardiac palpitations, flushing, and increased irritability or excitement (especially in children). Some individuals may display sympathomimetic amine effects such as tachycardia, palpitations, headache, dizziness, or nausea. Sympathomimetics have been associated with certain untoward reactions including fear, anxiety, nervousness, restlessness, tremor, weakness, pallor, respiratory difficulty, dysuria, insomnia, hallucinations, convulsions, CNS depression, arrhythmias, and cardiovascular collapse with hypotension. Urinary retention may occur in patients with prostatic hypertrophy. Antihistamines and anticholinergics may cause drowsiness, dizziness, blurred vision, and excessive dryness of the nose, throat, and mouth.
DRUG ABUSE AND DEPENDENCE:
Central nervous system stimulants such as phenylephrine have been abused. At high doses, subjects commonly experience an elevation of mood, sense of increased energy and alertness, and decreased appetite. With continued use, tolerance develops, the user increases the dose, and toxic signs and symptoms appear. Depression may follow rapid withdraw.
OVERDOSAGE AND TREATMENT OF OVERDOSAGE
The treatment of overdosage should provide symptomatic and supportive care. Induction of emesis and gastric lavage may be performed if the patient is alert and seen within early hours after ingestion. Drug remaining in the stomach may be absorbed by the administration of activated charcoal. Stimulants should not be used because they may precipitate convulsions. If convulsions or marked CNS excitement occurs, treatment with appropriate measures is indicated. Since the effects of AlleRx last up to 12 hours, the patient should be monitored for at least that length of time and treated as necessary.
DOSAGE AND ADMINISTRATION
Adults and adolescents 12 years of age and over: One orange AM tablet in the morning and one blue PM tablet in the evening. AlleRx is not recommended for children under 12 years of age.
HOW SUPPLIED
(NDC 10122-705-20) AlleRx PE Tablets 10 Day Treatment Regimen, containing 20 tablets as follows:
10 orange, elongated and scored AM tablets debossed with “CBP” on one side and “04” to the right of the score on the other side, each containing 40 mg phenylephrine HCl and 2.5 mg of methscopolamine nitrate. 10 blue, elongated and scored PM tablets debossed with “CBP” on one side and “05” to the right of the score on the other side, each containing 10 mg phenylephrine HCl, 8 mg of chlorpheniramine maleate and 2.5 mg of methscopolamine nitrate.
(NDC 10122-705-60) AlleRx PE Tablets 30 Day Treatment Regimen, containing 60 tablets as follows:
30 orange, elongated and scored AM tablets debossed with “CBP” on one side and “04” to the right of the score on the other side, each containing 40 mg phenylephrine HCl and 2.5 mg of methscopolamine nitrate. 30 blue, elongated and scored PM tablets debossed with “CBP” on one side and “05” to the right of the score on the other side, each containing 10 mg phenylephrine HCl, 8 mg of chlorpheniramine maleate and 2.5 mg of methscopolamine nitrate.
(NDC 10122-705-02) AlleRx PE Tablets 2-pack sample containing 1 orange AM tablet and 1 blue PM tablet per sample.
Keep out of reach of pediatric population.
Store at 20° - 25°C (68° - 77°F); excursions permitted to 15° – 30° C (59° – 86° F). See USP Controlled Room Temperature.
Distributed by Cornerstone Therapeutics Inc., Cary, NC 27518.
This product is licensed and protected under U.S. Patent No. 6,843,372 issued 01/18/2005.
Rx Only
CORNERSTONE THERAPEUTICS INC.™
© 2009 Cornerstone Therapeutics Inc., Cary, NC 27518
CTA726F0109
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| Marketing Information | |||
| Marketing Category | Application Number or Monograph Citation | Marketing Start Date | Marketing End Date |
| unapproved drug other | 09/01/2006 | ||
| Labeler - Cornerstone Therapeutics Inc. (153886994) |
| Establishment | |||
| Name | Address | ID/FEI | Operations |
| Sovereign Pharmaceuticals, Ltd. | 623168267 | MANUFACTURE | |
More AlleRx Dose Pack PE resources
- AlleRx Dose Pack PE Side Effects (in more detail)
- AlleRx Dose Pack PE Use in Pregnancy & Breastfeeding
- AlleRx Dose Pack PE Drug Interactions
- AlleRx Dose Pack PE Support Group
- 0 Reviews for AlleRx Dose Pack PE - Add your own review/rating
Compare AlleRx Dose Pack PE with other medications
- Nasal Congestion
- Rhinitis
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