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DRUGS & SUPPLEMENTS
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Bisoprolol:
Corbis-H (Bisoprolol) FUMARATE should be used with care when myocardial depressants or inhibitors of AV conduction, such as certain calcium antagonists (particularly of the phenylalkylamine [verapamil] and benzothiazepine [diltiazem] classes), or antiarrhythmic agents, such as disopyramide, are used concurrently.
Both digitalis glycosides and beta-blockers slow atrioventricular conduction and decrease heart rate. Concomitant use can increase the risk of bradycardia.
Concurrent use of rifampin increases the metabolic clearance of Corbis-H (Bisoprolol) FUMARATE, resulting in a shortened elimination half-life of Corbis-H (Bisoprolol) FUMARATE. However, initial dose modification is generally not necessary. Pharmacokinetic studies document no clinically relevant interactions with other agents given concomitantly, including thiazide diuretics and cimetidine. There was no effect of Corbis-H (Bisoprolol) FUMARATE on prothrombin time in patients on stable doses of warfarin.
Risk of Anaphylactic Reaction: While taking beta-blockers, patients with a history of severe anaphylactic reaction to a variety of allergens may be more reactive to repeated challenge, either accidental, diagnostic, or therapeutic. Such patients may be unresponsive to the usual doses of epinephrine used to treat allergic reactions.
Patients subject to spontaneous hypoglycemia, or diabetic patients receiving insulin or oral hypoglycemic agents, should be cautioned that beta-blockers may mask some of the manifestations of hypoglycemia, particularly tachycardia, and Corbis-H (Bisoprolol) fumarate should be used with caution.
Patients should know how they react to this medicine before they operate automobiles and machinery or engage in other tasks requiring alertness.
Reproduction studies in rats did not show any impairment of fertility at doses up to 150 mg/kg/day of Corbis-H (Bisoprolol) fumarate, or 375 and 77 times the MRHD on the basis of body weight and body surface area, respectively.
There are no adequate and well-controlled studies in pregnant women. Corbis-H (Bisoprolol) FUMARATE should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.
Observed reductions in heart rate were slightly greater in the elderly than in the young and tended to increase with increasing dose. In general, no disparity in adverse experience reports or dropouts for safety reasons was observed between older and younger patients. Dose adjustment based on age is not necessary.
In Study A, doses of 5, 10, and 20 mg Corbis-H fumarate were administered for 4 weeks. In Study B, doses of 2.5, 10, and 40 mg of Corbis-H (Bisoprolol) fumarate were administered for 12 weeks. A total of 273 patients were treated with 5 to 20 mg of Corbis-H (Bisoprolol) fumarate; 132 received placebo.
Withdrawal of therapy for adverse events was 3.3% for patients receiving Corbis-H (Bisoprolol) fumarate and 6.8% for patients on placebo. Withdrawals were less than 1% for either bradycardia or fatigue/lack of energy.
The following table presents adverse experiences, whether or not considered drug related, reported in at least 1% of patients in these studies, for all patients studied in placebo-controlled clinical trials (2.5 to 40 mg), as well as for a subgroup that was treated with doses within the recommended dosage range (5 to 20 mg). Of the adverse events listed in the table, bradycardia, diarrhea, asthenia, fatigue, and sinusitis appear to be dose related.
Body System / Adverse Experience | All AdverseExperiences (% a ) Bisoprolol Fumarate | ||
| Placebo | 5 to 20 mg | 2. 5 to 40 mg |
| ( n = 132 )
| ( n = 273 )
| ( n = 404 )
|
| % | % | % |
a percentage of patients with event | |||
| |||
Skin
| | | |
increased sweating | 1.5 | 0.7 | 1.0 |
Musculoskeletal
| | | |
arthralgia | 2.3 | 2.2 | 2.7 |
Central Nervous System
| | | |
dizziness | 3.8 | 2.9 | 3.5 |
headache | 11.4 | 8.8 | 10.9 |
hypoesthesia | 0.8 | 1.1 | 1.5 |
Autonomic Nervous System
| | | |
dry mouth | 1.5 | 0.7 | 1.3 |
Heart Rate / Rhythm
| | | |
bradycardia | 0 | 0.4 | 0.5 |
Psychiatric
| | | |
vivid dreams | 0 | 0 | 0 |
insomnia | 2.3 | 1.5 | 2.5 |
depression | 0.8 | 0 | 0.2 |
Gastrointestinal
| | | |
diarrhea | 1.5 | 2.6 | 3.5 |
nausea | 1.5 | 1.5 | 2.2 |
vomiting | 0 | 1.1 | 1.5 |
Respiratory
| | | |
bronchospasm | 0 | 0 | 0 |
cough | 4.5 | 2.6 | 2.5 |
dyspnea | 0.8 | 1.1 | 1.5 |
pharyngitis | 2.3 | 2.2 | 2.2 |
rhinitis | 3.0 | 2.9 | 4.0 |
sinusitis | 1.5 | 2.2 | 2.2 |
URI | 3.8 | 4.8 | 5.0 |
Body as a Whole
| | | |
asthenia | 0 | 0.4 | 1.5 |
chest pain | 0.8 | 1.1 | 1.5 |
fatigue | 1.5 | 6.6 | 8.2 |
edema (peripheral) | 3.8 | 3.7 | 3.0 |
In addition, a variety of adverse effects have been reported with other beta-adrenergic blocking agents and should be considered potential adverse effects of Corbis-H FUMARATE:
Central Nervous System
Reversible mental depression progressing to catatonia, hallucinations, an acute reversible syndrome characterized by disorientation to time and place, emotional lability, slightly clouded sensorium.
Allergic
Fever, combined with aching and sore throat, laryngospasm, respiratory distress.
Hematologic
Agranulocytosis, thrombocytopenia, thrombocytopenic purpura.
Gastrointestinal
Mesenteric arterial thrombosis, ischemic colitis.
Miscellaneous
The oculomucocutaneous syndrome associated with the beta-blocker practolol has not been reported with Corbis-H (Bisoprolol) FUMARATE during investigational use or extensive foreign marketing experience.
Sporadic liver test abnormalities have been reported. In the U.S. controlled trials experience with Corbis-H (Bisoprolol) fumarate treatment for 4-12 weeks, the incidence of concomitant elevations in SGOT and SGPT from 1 to 2 times normal was 3.9%, compared to 2.5% for placebo. No patient had concomitant elevations greater than twice normal.
In the long-term, uncontrolled experience with Corbis-H (Bisoprolol) fumarate treatment for 6-18 months, the incidence of one or more concomitant elevations in SGOT and SGPT from 1 to 2 times normal was 6.2%. The incidence of multiple occurrences was 1.9%. For concomitant elevations in SGOT and SGPT of greater than twice normal, the incidence was 1.5%. The incidence of multiple occurrences was 0.3%. In many cases these elevations were attributed to underlying disorders, or resolved during continued treatment with Corbis-H (Bisoprolol) fumarate.
Other laboratory changes included small increases in uric acid, creatinine, BUN, serum potassium, glucose, and phosphorus and decreases in WBC and platelets. These were generally not of clinical importance and rarely resulted in discontinuation of Corbis-H (Bisoprolol) fumarate.
As with other beta-blockers, ANA conversions have also been reported on Corbis-H (Bisoprolol) fumarate. About 15% of patients in long-term studies converted to a positive titer, although about one-third of these patients subsequently reconverted to a negative titer while on continued therapy.
In general, if overdose occurs, Corbis-H (Bisoprolol) FUMARATE therapy should be stopped and supportive and symptomatic treatment should be provided. Limited data suggest that Corbis-H (Bisoprolol) fumarate is not dialyzable. Based on the expected pharmacologic actions and recommendations for other beta-blockers, the following general measures should be considered when clinically warranted:
Bradycardia
Administer IV atropine. If the response is inadequate, isoproterenol or another agent with positive chronotropic properties may be given cautiously. Under some circumstances, transvenous pacemaker insertion may be necessary.
Hypotension
IV fluids and vasopressors should be administered. Intravenous glucagon may be useful.
Heart Block (second or third degree)
Patients should be carefully monitored and treated with isoproterenol infusion or transvenous cardiac pacemaker insertion, as appropriate.
Congestive Heart Failure
Initiate conventional therapy (i.e., digitalis, diuretics, inotropic agents, vasodilating agents).
Bronchospasm
Administer bronchodilator therapy such as isoproterenol and/or aminophylline.
Hypoglycemia
Administer IV glucose.
Product: 63629-5173
NDC: 63629-5173-1 30 TABLET in a BOTTLE
NDC: 63629-5173-2 100 TABLET in a BOTTLE
NDC: 63629-5173-3 90 TABLET in a BOTTLE
Manufactured by:
UNICHEM LABORATORIES LTD.
Pilerne Ind. Estate, Pilerne, Bardez,
Goa 403 511, India.
Marketed by:
Hasbrouck Heights, NJ 07604.
02-R-06/2016
13007902
Hydrochlorothiazide:
Corbis-H (Hydrochlorothiazide) is an antihypertensive, diuretic drug that acts on the electrolyte reabsorption in the renal tubular mechanism increasing the excretion of chloride and sodium in equivalent amounts. The exact mechanism of its antihypertensive action is not known at this time.
Corbis-H (Hydrochlorothiazide) is typically employed for the treatment of patients suffering from hypertension, either as monotherapy or in combination with other antihypertensive medication. It is also employed in some cases as a diuretic agent. Corbis-H (Hydrochlorothiazide) therapy may also be prescribed for the treatment of hepatic cirrhosis, edema (in patients suffering from congestive heart failure), nephrotic syndrome, drug induced edema, chronic renal failure or acute glomerulonephritis. Health care professionals may prescribe this drug in order to treat other medical conditions as well; if you would like to know more about the reasons you have been prescribed this drug, it is advised to ask your personal physician.
Corbis-H (Hydrochlorothiazide) may not be used in the treatment of patients who are allergic to this drug, any of its components or other sulfonamide-derived medication. Also, this drug may not be suitable for use in patients that are suffering from anuria, azotemia or impaired renal functions. Caution should be employed if the patient is suffering from hepatic disease. Other medical conditions may also influence the examining health care provider's decision of prescribing Corbis-H (Hydrochlorothiazide); it is strongly recommended to make sure that the health care professional is fully aware of your health condition and medical history before starting a treatment with this drug.
Use of Corbis-H (Hydrochlorothiazide) during pregnancy or breast-feeding is also not recommended. This medicine may affect an unborn baby and it also passes into breast milk. As such, use of this drug in pregnant women or breast-feeding mothers should not be employed.
You should always take Corbis-H (Hydrochlorothiazide) as you have been directed by the prescribing health care specialist. While in some cases daily administration of the drug is recommended, other patients may be prescribed an intermittent therapy. Also, the number of daily doses may vary. As such, it is best that you do not follow another patient's intake schedule. If you have difficulties understanding the intake guidelines that your prescribing health care professional has provided, you should ask for further explanations from an authorized health care specialist - such as a pharmacist, a doctor or a nurse.
The exact Corbis-H (Hydrochlorothiazide) dosage may vary greatly from one case to another, depending on the condition being treated, on the patient's medical history and general health condition, on his or her age as well as on a number of other factors. As such you are advised to use the exact Corbis-H (Hydrochlorothiazide) dosage that has been prescribed to you and never use the dosage prescribed to another patient or a dosage that you have been prescribed in the past. Taking a different Corbis-H (Hydrochlorothiazide) dose may cause the treatment to not have the desired effect, and if you take this drug in larger doses you may have a higher risk of developing side effects, or you may suffer from an overdose.
You should never exceed the Corbis-H (Hydrochlorothiazide) prescribed dosage, in order to avoid an overdose with this medication. However, if you consider that you are affected by an overdose with this drug it is advised to immediately consult your personal health care provider, the local poisons center or to go to the nearest medical facility to seek emergency medical attention. The common symptoms of an overdose with Corbis-H (Hydrochlorothiazide) are dehydration and cardiac arrhythmia. The patient may also suffer from electrolyte depletion and thus may present the relevant signs and symptoms.
In case you have missed a dose of Corbis-H (Hydrochlorothiazide), it is advised that you take the dose as soon as you remember. If the moment when you remember is too close to another intake of the medication, you should completely skip the missed Corbis-H (Hydrochlorothiazide) dose and take the next scheduled dose on time. You should never take a larger dose of the drug in order to make up for a missed dose, unless your prescribing health care provider directs you to do so.
In some patients Corbis-H (Hydrochlorothiazide) may cause side effects. While they are not very common, it is recommended to let your personal health care provider know if you begin experiencing any side effects. Several types of symptoms are possible: dizziness, headache, paresthesias, gastric irritation, anorexia, nausea and vomiting, diarrhea or constipation, pancreatitis, jaundice, hypotension. Metabolic side effects may include glycosuria, hyperglycemia, hyperuricemia, hypokalemia or hyponatremia. Renal failure or dysfunction may develop, as well as interstitial nephritis. Some patients reported experiencing muscle spasms, restlessness, unusual weakness and blurred vision. In some cases photosensitivity, anaphylactic reactions, respiratory distress, fever, rashes, vasculitis or toxic epidermal necrolysis have occurred.
Corbis-H (Hydrochlorothiazide) may interact with barbiturates and narcotics, as well as with alcohol. If you are also following a treatment course with antidiabetic drugs, their dosage may need to be adjusted before starting to take Corbis-H (Hydrochlorothiazide). This drug may have an additive effect with other antihypertensive medication. ACE inhibitors, ACTH, corticosteroids and skeletal muscle relaxants may also interact with this drug causing unwanted effects. This drug may not be properly absorbed if the patient is also taking Colestipol resins or Cholestyramine. NSAIDs, lithium and Pressor amines may affect or be affected by Corbis-H (Hydrochlorothiazide), and as such it is strongly recommended to let the prescribing health care provider know if you are taking these or any other drugs before starting a therapy course with this medicine. Other drug interactions that are not listed here are also possible.
Depending on the reaction of the Corbis-H after taken, if you are feeling dizziness, drowsiness or any weakness as a reaction on your body, Then consider Corbis-H not safe to drive or operate heavy machine after consumption. Meaning that, do not drive or operate heavy duty machines after taking the capsule if the capsule has a strange reaction on your body like dizziness, drowsiness. As prescribed by a pharmacist, it is dangerous to take alcohol while taking medicines as it exposed patients to drowsiness and health risk. Please take note of such effect most especially when taking Primosa capsule. It's advisable to consult your doctor on time for a proper recommendation and medical consultations.
Is Corbis-H addictive or habit forming?Medicines are not designed with the mind of creating an addiction or abuse on the health of the users. Addictive Medicine is categorically called Controlled substances by the government. For instance, Schedule H or X in India and schedule II-V in the US are controlled substances.
Please consult the medicine instruction manual on how to use and ensure it is not a controlled substance.In conclusion, self medication is a killer to your health. Consult your doctor for a proper prescription, recommendation, and guidiance.
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The information was verified by Dr. Rachana Salvi, MD Pharmacology