Clonafit beta

Clonafit beta Medicine

Contraindications

See also:
What is the most important information I should know about Clonazepam (Clonafit BETA)?

You should not use this medication if you have severe liver disease, of if you are allergic to Clonazepam (Clonafit BETA) or to other benzodiazepines, such as alprazolam (Xanax), chlordiazepoxide (Librium), clorazepate (Tranxene), diazepam (Valium), lorazepam (Ativan), or oxazepam (Serax).

Clonazepam (Clonafit BETA) may cause harm to an unborn baby, and may cause breathing or feeding problems in a newborn. But having seizures during pregnancy could harm both mother and baby. Do not start or stop taking Clonazepam (Clonafit BETA) during pregnancy without medical advice.

You may have thoughts about suicide while taking this medication. Your doctor will need to check you at regular visits. Do not miss any scheduled appointments. Call your doctor at once if you have any new or worsening symptoms such as: mood or behavior changes, depression, anxiety, or if you feel agitated, irritable, hostile, aggressive, restless, hyperactive (mentally or physically), or have thoughts about suicide or hurting yourself.

Before you take Clonazepam (Clonafit BETA), tell your doctor if you have kidney or liver disease, glaucoma, any breathing problems, or a history of depression, suicidal thoughts, or addiction to drugs or alcohol.

Do not drink alcohol while taking Clonazepam (Clonafit BETA). This medication can increase the effects of alcohol.

Clonazepam (Clonafit BETA) 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.

See also:
What is the most important information I should know about Propranolol (Clonafit BETA)?

Propranolol (Clonafit BETA) must not be used if there is a history of bronchial asthma or bronchospasm.

Bronchospasm can usually be reversed by beta-2 agonist bronchodilators such as salbutamol. Large doses of the beta-2-agonist bronchodilator may be required to overcome the beta-blockade produced by Propranolol (Clonafit BETA) and the dose should be titrated according to the clinical response; both intravenous and inhalational administration should be considered. The use of intravenous aminophylline and/or the use of ipratropium, (given by nebuliser), may also be considered. Glucagon (1 to 2 mg given intravenously) has also been reported to produce a bronchodilator effect in asthmatic patients. Oxygen or artificial ventilation may be required in severe cases.

Propranolol (Clonafit BETA) as with other beta-blockers must not be used in patients with any of the following: Known hypersensitivity to the substance; bradycardia; cardiogenic shock; hypotension; metabolic acidosis; after prolonged fasting; severe peripheral arterial circulatory disturbances; second or third degree heart block; sick sinus syndrome; untreated (with an alpha adrenoceptor antagonist) phaeochromocytoma; uncontrolled heart failure; Prinzmetal's angina.

Propranolol (Clonafit BETA) must not be used in patients prone to hypoglycaemia, i.e., patients after prolonged fasting or patients with restricted counter-regulatory reserves. Patients with restricted-counter regulatory reserves may have reduced autonomic and hormonal responses to hypoglycaemia which includes glycogenolysis, gluconeogenesis and/or impaired modulation of insulin secretion. Patients at risk for an inadequate response to hypoglycaemia includes individuals with malnutrition, prolonged fasting, starvation, chronic liver disease, diabetes and concomitant use of drugs which block the full response to catecholamines.



Undesirable effects

See also:
What are the possible side effects of Clonazepam (Clonafit BETA)?

The adverse experiences for Clonazepam (Clonafit BETA) are provided separately for patients with seizure disorders and with panic disorder.

Seizure Disorders

The most frequently occurring side effects of Clonazepam (Clonafit BETA) are referable to CNS depression. Experience in treatment of seizures has shown that drowsiness has occurred in approximately 50% of patients and ataxia in approximately 30%. In some cases, these may diminish with time; behavior problems have been noted in approximately 25% of patients. Others, listed by system, including those identified during postapproval use of Clonazepam (Clonafit BETA) are:

Cardiovascular: Palpitations

Dermatologic: Hair loss, hirsutism, skin rash, ankle and facial edema

Gastrointestinal: Anorexia, coated tongue, constipation, diarrhea, dry mouth, encopresis, gastritis, increased appetite, nausea, sore gums

Genitourinary: Dysuria, enuresis, nocturia, urinary retention

Hematopoietic: Anemia, leukopenia, thrombocytopenia, eosinophilia

Hepatic: Hepatomegaly, transient elevations of serum transaminases and alkaline phosphatase

Musculoskeletal: Muscle weakness, pains

Miscellaneous: Dehydration, general deterioration, fever, lymphadenopathy, weight loss or gain

Neurologic: Abnormal eye movements, aphonia, choreiform movements, coma, diplopia, dysarthria, dysdiadochokinesis, ''glassy-eyed'' appearance, headache, hemiparesis, hypotonia, nystagmus, respiratory depression, slurred speech, tremor, vertigo

Psychiatric: Confusion, depression, amnesia, hallucinations, hysteria, increased libido, insomnia, psychosis (the behavior effects are more likely to occur in patients with a history of psychiatric disturbances). The following paradoxical reactions have been observed: excitability, irritability, aggressive behavior, agitation, nervousness, hostility, anxiety, sleep disturbances, nightmares and vivid dreams

Respiratory: Chest congestion, rhinorrhea, shortness of breath, hypersecretion in upper respiratory passages

Panic Disorder

Adverse events during exposure to Clonazepam (Clonafit BETA) were obtained by spontaneous report and recorded by clinical investigators using terminology of their own choosing. Consequently, it is not possible to provide a meaningful estimate of the proportion of individuals experiencing adverse events without first grouping similar types of events into a smaller number of standardized event categories. In the tables and tabulations that follow, CIGY dictionary terminology has been used to classify reported adverse events, except in certain cases in which redundant terms were collapsed into more meaningful terms, as noted below.

The stated frequencies of adverse events represent the proportion of individuals who experienced, at least once, a treatment-emergent adverse event of the type listed. An event was considered treatment-emergent if it occurred for the first time or worsened while receiving therapy following baseline evaluation.

Adverse Findings Observed In Short-Term, Placebo-Controlled TrialsAdverse Events Associated With Discontinuation Of Treatment

Overall, the incidence of discontinuation due to adverse events was 17% in Clonazepam (Clonafit BETA) compared to 9% for placebo in the combined data of two 6-to 9-week trials. The most common events ( ≥ 1%) associated with discontinuation and a dropout rate twice or greater for Clonazepam (Clonafit BETA) than that of placebo included the following:

Table 2 : Most Common Adverse Events ( ≥ 1%) Associated with Discontinuation of Treatment

Adverse Event Clonazepam (Clonafit BETA)

(N=574)

Placebo

(N=294)

Somnolence 7% 1%
Depression 4% 1%
Dizziness 1% < 1%
Nervousness 1% 0%
Ataxia 1% 0%
Intellectual Ability Reduced 1% 0%
Adverse Events Occurring At An Incidence Of 1% Or More Among Clonazepam (Clonafit BETA)-Treated Patients:

Table 3 enumerates the incidence, rounded to the nearest percent, of treatment-emergent adverse events that occurred during acute therapy of panic disorder from a pool of two 6to 9-week trials. Events reported in 1% or more of patients treated with Clonazepam (Clonafit BETA) (doses ranging from 0.5 to 4 mg/day) and for which the incidence was greater than that in placebo-treated patients are included.

The prescriber should be aware that the figures in Table 3 cannot be used to predict the incidence of side effects in the course of usual medical practice where patient characteristics and other factors differ from those that prevailed in the clinical trials. Similarly, the cited frequencies cannot be compared with figures obtained from other clinical investigations involving different treatments, uses and investigators. The cited figures, however, do provide the prescribing physician with some basis for estimating the relative contribution of drug and nondrug factors to the side effect incidence in the population studied.

Table 3 : Treatment-Emergent Adverse Event Incidence in 6-to 9Week Placebo-Controlled Clinical Trials*

Adverse Event by Body System Clonazepam (Clonafit BETA) Maximum Daily Dose
< 1mg

n=96 %

1- < 2mg

n=129 %

2- < 3mg

n=113 %

> 3mg

n=235 %

All Clonazepam (Clonafit BETA) Groups

N=574 %

Placebo

N=294 %

Central & Peripheral Nervous System
Somnolence† 26 35 50 36 37 10
Dizziness 5 5 12 8 8 4
Coordination Abnormal† 1 2 7 9 6 0
Ataxia† 2 1 8 8 5 0
Dysarthria† 0 0 4 3 2 0
Psychiatric
Depression 7 6 8 8 7 1
Memory Disturbance 2 5 2 5 4 2
Nervousness 1 4 3 4 3 2
Intellectual Ability Reduced 0 2 4 3 2 0
Emotional Lability 0 1 2 2 1 1
Libido Decreased 0 1 3 1 1 0
Confusion 0 2 2 1 1 0
Respiratory System
Upper Respiratory Tract Infection† 10 10 7 6 8 4
Sinusitis 4 2 8 4 4 3
Rhinitis 3 2 4 2 2 1
Coughing 2 2 4 0 2 0
Pharyngitis 1 1 3 2 2 1
Bronchitis 1 0 2 2 1 1
Gastrointestinal System
Constipation† 0 1 5 3 2 2
Appetite Decreased 1 1 0 3 1 1
Abdominal Pain† 2 2 2 0 1 1
Body as a Whole
Fatigue 9 6 7 7 7 4
Allergic Reaction 3 1 4 2 2 1
Musculoskeletal
Myalgia 2 1 4 0 1 1
Resistance MechanismDisorders
Influenza Urinary System 3 2 5 5 4 3
Micturition Frequency 1 2 2 1 1 0
Urinary Tract Infection† 0 0 2 2 1 0
Vision Disorders
Blurred Vision 1 2 3 0 1 1
Reproductive Disorders†
Female
Dysmenorrhea 0 6 5 2 3 2
Colpitis 4 0 2 1 1 1
Male
Ejaculation Delayed 0 0 2 2 1 0
Impotence 3 0 2 1 1 0
* Events reported by at least 1% of patients treated with Clonazepam (Clonafit BETA) and for which the incidence was greater than that for placebo.

† Indicates that the p-value for the dose-trend test (Cochran-Mantel-Haenszel) for adverse event incidence was ≤ 0.10.

‡ Denominators for events in gender-specific systems are: n=240 (Clonazepam (Clonafit BETA)), 102 (placebo) for male, and 334 (Clonazepam (Clonafit BETA)), 192 (placebo) for female.

Commonly Observed Adverse Events

Table 4 : Incidence of Most Commonly Observed Adverse Events* in Acute Therapy in Pool of 6-to 9-Week Trials

Adverse Event (Genentech Preferred Term) Clonazepam (Clonafit BETA)

(N=574)

Placebo

(N=294)

Somnolence 37% 10%
Depression 7% 1%
Coordination Abnormal 6% 0%
Ataxia 5% 0%
* Treatment-emergent events for which the incidence in the Clonazepam (Clonafit BETA) patients was ≥ 5% and at least twice that in the placebo patients.
Treatment-Emergent Depressive Symptoms

In the pool of two short-term placebo-controlled trials, adverse events classified under the preferred term “depression” were reported in 7% of Clonazepam (Clonafit BETA)-treated patients compared to 1% of placebo-treated patients, without any clear pattern of dose relatedness. In these same trials, adverse events classified under the preferred term “depression” were reported as leading to discontinuation in 4% of Clonazepam (Clonafit BETA)-treated patients compared to 1% of placebo-treated patients. While these findings are noteworthy, Hamilton Depression Rating Scale (HAM-D) data collected in these trials revealed a larger decline in HAM-D scores in the Clonazepam (Clonafit BETA) group than the placebo group suggesting that clonazepamtreated patients were not experiencing a worsening or emergence of clinical depression.

Other Adverse Events Observed During The Premarketing Evaluation Of Clonazepam (Clonafit BETA) In Panic Disorder

Following is a list of modified CIGY terms that reflect treatment-emergent adverse events reported by patients treated with Clonazepam (Clonafit BETA) at multiple doses during clinical trials. All reported events are included except those already listed in Table 3 or elsewhere in labeling, those events for which a drug cause was remote, those event terms which were so general as to be uninformative, and events reported only once and which did not have a substantial probability of being acutely life-threatening. It is important to emphasize that, although the events occurred during treatment with Clonazepam (Clonafit BETA), they were not necessarily caused by it.

Events are further categorized by body system and listed in order of decreasing frequency. These adverse events were reported infrequently, which is defined as occurring in 1/100 to 1/1000 patients.

Body as a Whole: weight increase, accident, weight decrease, wound, edema, fever, shivering, abrasions, ankle edema, edema foot, edema periorbital, injury, malaise, pain, cellulitis, inflammation localized

Cardiovascular Disorders: chest pain, hypotension postural

Central and Peripheral Nervous System Disorders: migraine, paresthesia, drunkenness, feeling of enuresis, paresis, tremor, burning skin, falling, head fullness, hoarseness, hyperactivity, hypoesthesia, tongue thick, twitching

Gastrointestinal System Disorders: abdominal discomfort, gastrointestinal inflammation, stomach upset, toothache, flatulence, pyrosis, saliva increased, tooth disorder, bowel movements frequent, pain pelvic, dyspepsia, hemorrhoids

Hearing and Vestibular Disorders: vertigo, otitis, earache, motion sickness

Heart Rate and Rhythm Disorders: palpitation

Metabolic and Nutritional Disorders: thirst, gout

Musculoskeletal System Disorders: back pain, fracture traumatic, sprains and strains, pain leg, pain nape, cramps muscle, cramps leg, pain ankle, pain shoulder, tendinitis, arthralgia, hypertonia, lumbago, pain feet, pain jaw, pain knee, swelling knee

Platelet, Bleeding and Clotting Disorders: bleeding dermal

Psychiatric Disorders: insomnia, organic disinhibition, anxiety, depersonalization, dreaming excessive, libido loss, appetite increased, libido increased, reactions decreased, aggressive reaction, apathy, attention lack, excitement, feeling mad, hunger abnormal, illusion, nightmares, sleep disorder, suicide ideation, yawning

Reproductive Disorders, Female: breast pain, menstrual irregularity

Reproductive Disorders, Male: ejaculation decreased

Resistance Mechanism Disorders: infection mycotic, infection viral, infection streptococcal, herpes simplex infection, infectious mononucleosis, moniliasis

Respiratory System Disorders: sneezing excessive, asthmatic attack, dyspnea, nosebleed, pneumonia, pleurisy

Skin and Appendages Disorders: acne flare, alopecia, xeroderma, dermatitis contact, flushing, pruritus, pustular reaction, skin burns, skin disorder

Special Senses Other, Disorders: taste loss

Urinary System Disorders: dysuria, cystitis, polyuria, urinary incontinence, bladder dysfunction, urinary retention, urinary tract bleeding, urine discoloration

Vascular (Extracardiac) Disorders: thrombophlebitis leg

Vision Disorders: eye irritation, visual disturbance, diplopia, eye twitching, styes, visual field defect, xerophthalmia

Drug Abuse And DependenceControlled Substance Class

Clonazepam (Clonafit BETA) is a Schedule IV controlled substance.

Physical And Psychological Dependence

Withdrawal symptoms, similar in character to those noted with barbiturates and alcohol (eg, convulsions, psychosis, hallucinations, behavioral disorder, tremor, abdominal and muscle cramps) have occurred following abrupt discontinuance of Clonazepam (Clonafit BETA). The more severe withdrawal symptoms have usually been limited to those patients who received excessive doses over an extended period of time. Generally milder withdrawal symptoms (eg, dysphoria and insomnia) have been reported following abrupt discontinuance of benzodiazepines taken continuously at therapeutic levels for several months. Consequently, after extended therapy, abrupt discontinuation should generally be avoided and a gradual dosage tapering schedule followed. Addiction-prone individuals (such as drug addicts or alcoholics) should be under careful surveillance when receiving Clonazepam (Clonafit BETA) or other psychotropic agents because of the predisposition of such patients to habituation and dependence.

Following the short-term treatment of patients with panic disorder in Studies 1 and 2, patients were gradually withdrawn during a 7-week downward-titration (discontinuance) period. Overall, the discontinuance period was associated with good tolerability and a very modest clinical deterioration, without evidence of a significant rebound phenomenon. However, there are not sufficient data from adequate and well-controlled long-term Clonazepam (Clonafit BETA) studies in patients with panic disorder to accurately estimate the risks of withdrawal symptoms and dependence that may be associated with such use.

See also:
What are the possible side effects of Propranolol (Clonafit BETA)?

The following serious adverse reactions are discussed in greater detail in other sections of the labeling:

  • Hypoglycemia and related events, like hypoglycemic seizure.
  • Bronchospasm.
Clinical Trials Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug may not reflect the rates observed in clinical practice.

Clinical Trials Experience with Propranolol (Clonafit BETA) in Infants with proliferating infantile hemangioma

In clinical trials for proliferating infantile hemangioma, the most frequently reported adverse reactions ( > 10%) in infants treated with Propranolol (Clonafit BETA) were sleep disorders, aggravated respiratory tract infections such as bronchitis and bronchiolitis associated with cough and fever, diarrhea, and vomiting. Adverse reactions led to treatment discontinuation in fewer than 2% of treated patients.

Overall, 479 patients in the pooled safety population were exposed to study drug in the clinical study program (456 in placebo-controlled trials). A total of 424 patients were treated with Propranolol (Clonafit BETA) at doses 1.2 mg/kg/day or 3.4 mg/kg/day for 3 or 6 months. Of these, 63% of patients were aged 91-150 days and 37% were aged 35-90 days at randomization.

The following table lists according to the dosage the most common adverse reactions (treatment-emergent adverse events with an incidence at least 3% greater on one of the two doses than on placebo).

Table 2: Treatment-emergent adverse events occurring at least 3% more often on Propranolol (Clonafit BETA) than on placebo.

Reaction Placebo

N=236

Propranolol (Clonafit BETA) 1.2 mg/kg/day

N=200

Propranolol (Clonafit BETA) 3.4 mg/kg/day

N=224

Sleep disorder 5.90% 17.50% 16.10%
Bronchitis 4.7 8 13.4
Peripheral coldness 0.4 8 6.7
Agitation 2.1 8.5 4.5
Diarrhea 1.3 4.5 6.3
Somnolence 0.4 5 0.9
Nightmare 1.7 2 6.3
Irritability 1.3 5.5 1.3
Decreased appetite 0.4 2.5 3.6
Abdominal pain 0.4 3.5 0.4

The following adverse events have been observed during clinical studies, with an incidence of less than 1%:

Cardiac disorders: Second degree atrioventricular heart block, in a patient with underlying conduction disorder, required definitive treatment discontinuation.

Skin and subcutaneous tissue disorders: Urticaria, alopecia

Investigations: Decreased blood glucose, decreased heart rate

Compassionate Use Program

More than 600 infants received Propranolol (Clonafit BETA) in a compassionate use program (CUP). Mean age at treatment initiation was 3.6 months. Mean dose of Propranolol (Clonafit BETA) was 2.2 mg/kg/day and mean treatment duration was 7.1 months.

The adverse reactions reported in the CUP were similar to the ADRs observed during clinical trials but some were more severe.

Postmarketing Experience

The following adverse reactions have been identified during post-approval use of Propranolol (Clonafit BETA). Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

These adverse reactions are as follows:

Blood and lymphatic system disorders: Agranulocytosis

Psychiatric disorders: Hallucination

Skin and subcutaneous tissues disorders: Purpura

Therapeutic indications

An indication is a term used for the list of condition or symptom or illness for which the medicine is prescribed or used by the patient. For example, acetaminophen or paracetamol is used for fever by the patient, or the doctor prescribes it for a headache or body pains. Now fever, headache and body pains are the indications of paracetamol. A patient should be aware of the indications of medications used for common conditions because they can be taken over the counter in the pharmacy meaning without prescription by the Physician.Seizure Disorders

Clonazepam (Clonafit BETA)

Orally Disintegrating Tablets USP are useful alone or as an adjunct in the treatment of the Lennox-Gastaut syndrome (petit mal variant), akinetic and myoclonic seizures. In patients with absence seizures (petit mal) who have failed to respond to succinimides, Clonazepam (Clonafit BETA)

Orally Disintegrating Tablets USP may be useful.

In some studies, up to 30% of patients have shown a loss of anticonvulsant activity, often within 3 months of administration. In some cases, dosage adjustment may reestablish efficacy.

Panic Disorder

Clonazepam (Clonafit BETA)

Orally Disintegrating Tablets USP are indicated for the treatment of panic disorder, with or without agoraphobia, as defined in DSM-IV. Panic disorder is characterized by the occurrence of unexpected panic attacks and associated concern about having additional attacks, worry about the implications or consequences of the attacks, and/or a significant change in behavior related to the attacks.

The efficacy of Clonazepam (Clonafit BETA) was established in two 6 to 9 week trials in panic disorder patients whose diagnoses corresponded to the DSM-IIIR category of panic disorder.

Panic disorder (DSM-IV) is characterized by recurrent unexpected panic attacks, i.e., a discrete period of intense fear or discomfort in which four (or more) of the following symptoms develop abruptly and reach a peak within 10 minutes: (1) palpitations, pounding heart or accelerated heart rate; (2) sweating; (3) trembling or shaking; (4) sensations of shortness of breath or smothering; (5) feeling of choking; (6) chest pain or discomfort; (7) nausea or abdominal distress; (8) feeling dizzy, unsteady, lightheaded or faint; (9) derealization (feelings of unreality) or depersonalization (being detached from oneself); (10) fear of losing control; (11) fear of dying; (12) paresthesias (numbness or tingling sensations); (13) chills or hot flushes.

The effectiveness of Clonazepam (Clonafit BETA) in long-term use, that is, for more than 9 weeks, has not been systematically studied in controlled clinical trials. The physician who elects to use Clonazepam (Clonafit BETA)

Orally Disintegrating Tablets USP for extended periods should periodically reevaluate the long-term usefulness of the drug for the individual patient.

An indication is a term used for the list of condition or symptom or illness for which the medicine is prescribed or used by the patient. For example, acetaminophen or paracetamol is used for fever by the patient, or the doctor prescribes it for a headache or body pains. Now fever, headache and body pains are the indications of paracetamol. A patient should be aware of the indications of medications used for common conditions because they can be taken over the counter in the pharmacy meaning without prescription by the Physician.Hypertension

Propranolol (Clonafit BETA) hydrochloride tablets USP are indicated in the management of hypertension. It may be used alone or used in combination with other antihypertensive agents, particularly a thiazide diuretic. Propranolol (Clonafit BETA) hydrochloride tablets USP are not indicated in the management of hypertensive emergencies.

Angina Pectoris Due to Coronary Atherosclerosis

Propranolol (Clonafit BETA) hydrochloride tablets USP are indicated to decrease angina frequency and increase exercise tolerance in patients with angina pectoris.

Atrial Fibrillation

Propranolol (Clonafit BETA) hydrochloride tablets USP are indicated to control ventricular rate in patients with atrial fibrillation and a rapid ventricular response.

Myocardial Infarction

Propranolol (Clonafit BETA) hydrochloride tablets USP are indicated to reduce cardiovascular mortality in patients who have survived the acute phase of myocardial infarction and are clinically stable.

Migraine

Propranolol (Clonafit BETA) hydrochloride tablets USP are indicated for the prophylaxis of common migraine headache. The efficacy of Propranolol (Clonafit BETA) in the treatment of a migraine attack that has started has not been established, and Propranolol (Clonafit BETA) is not indicated for such use.

Essential Tremor

Propranolol (Clonafit BETA) hydrochloride tablets USP are indicated in the management of familial or hereditary essential tremor. Familial or essential tremor consists of involuntary, rhythmic, oscillatory movements, usually limited to the upper limbs. It is absent at rest, but occurs when the limb is held in a fixed posture or position against gravity and during active movement. Propranolol (Clonafit BETA) hydrochloride tablets USP cause a reduction in the tremor amplitude, but not in the tremor frequency. Propranolol (Clonafit BETA) hydrochloride tablets USP are not indicated for the treatment of tremor associated with Parkinsonism.

Hypertrophic Subaortic Stenosis

Propranolol (Clonafit BETA) hydrochloride tablets USP improve NYHA functional class in symptomatic patients with hypertrophic subaortic stenosis.

Pheochromocytoma

Propranolol (Clonafit BETA) hydrochloride tablets USP are indicated as an adjunct to alpha-adrenergic blockade to control blood pressure and reduce symptoms of catecholamine-secreting tumors.

Clonazepam (Clonafit BETA) (Clonazepam (Clonafit BETA)) is a benzodiazepine. Clonazepam (Clonafit BETA) affects chemicals in the brain that may be unbalanced. Clonazepam (Clonafit BETA) is also a seizure medicine, also called an anti-epileptic drug.

Clonazepam (Clonafit BETA) is used to treat certain seizure disorders (including absence seizures or Lennox-Gastaut syndrome) in adults and children.

Clonazepam (Clonafit BETA) is also used to treat panic disorder (including agoraphobia) in adults.

Propranolol (Clonafit BETA) is used alone or together with other medicines to treat high blood pressure (hypertension). High blood pressure adds to the workload of the heart and arteries. If it continues for a long time, the heart and arteries may not function properly. This can damage the blood vessels of the brain, heart, and kidneys, resulting in a stroke, heart failure, or kidney failure. Lowering blood pressure may reduce the risk of stroke and heart attacks.

Propranolol (Clonafit BETA) is also used to treat severe chest pain (angina), migraine headaches, or hypertrophic subaortic stenosis (thickened heart muscle).

Propranolol (Clonafit BETA) may also be used to treat irregular heartbeats, tremors, or pheochromocytoma (adrenal gland tumor). It may also be used to reduce the risk of death in patients who have heart attacks.

Propranolol (Clonafit BETA) oral solution is used to treat proliferating infantile hemangioma.

Propranolol (Clonafit BETA) is a beta-blocker. It works by affecting the response to nerve impulses in certain parts of the body, like the heart. As a result, the heart beats slower and decreases the blood pressure. When the blood pressure is lowered, the amount of blood and oxygen is increased to the heart.

Propranolol (Clonafit BETA) is available only with your doctor's prescription.

Name of the medicinal product

Clonafit BETA

Qualitative and quantitative composition

Clonazepam (Clonafit BETA) is 5-(o-chlorophenyl)-1,3-dihydro-7-nitro-2H-1,4-benzodiazepin-2-one.

A widely used non-cardioselective beta-adrenergic antagonist. R,S-Propranolol (Clonafit BETA) Hydrochloride is used in the treatment or prevention of many disorders including acute myocardial infarction, arrhythmias, angina pectoris, hypertension, hypertensive emergencies, hyperthyroidism, migraine, pheochromocytoma, menopause, and anxiety.

Special warnings and precautions for use

Use Clonazepam (Clonafit BETA) as directed by your doctor. Check the label on the medicine for exact dosing instructions.

  • Take Clonazepam (Clonafit BETA) by mouth with or without food.
  • Do not remove the blister from the outer pouch until you are ready to take Clonazepam (Clonafit BETA). Make sure that your hands are dry when you open the blister pack. Do not push the tablet through the foil. Peel back the foil on the blister pack and place the tablet on your tongue. The tablet dissolves quickly and can be swallowed with saliva. Take Clonazepam (Clonafit BETA) with water. Take the tablet immediately after opening the blister pack. Do not store the removed tablet for future use
  • If you are taking Clonazepam (Clonafit BETA) for the prevention of seizures, taking Clonazepam (Clonafit BETA) at the same times each day will help you remember to take it.
  • Continue to take Clonazepam (Clonafit BETA) even if you feel well. Do not miss any doses. Clonazepam (Clonafit BETA) works best when there is a constant level of Clonazepam (Clonafit BETA) in your body.
  • If you miss a dose of Clonazepam (Clonafit BETA) and you are taking it regularly, take it as soon as possible. If several hours have passed or if it is nearing time for the next dose, do not double the dose to catch up, unless advised by your health care provider. Do not take 2 doses at once.

Ask your health care provider any questions you may have about how to use Clonazepam (Clonafit BETA).

Use Propranolol (Clonafit BETA) solution as directed by your doctor. Check the label on the medicine for exact dosing instructions.

  • Propranolol (Clonafit BETA) solution comes with extra patient information sheets called a Medication Guide and Instructions for Use. Read them carefully. Read them again each time you get Propranolol (Clonafit BETA) solution refilled.
  • Do NOT shake Propranolol (Clonafit BETA) solution before use.
  • Use the syringe that comes with Propranolol (Clonafit BETA) solution to measure the dose. Ask the pharmacist for help if you are unsure of how to measure the dose.
  • Give Propranolol (Clonafit BETA) solution right into your child's mouth. If needed, Propranolol (Clonafit BETA) solution may be mixed in a small amount of milk or fruit juice and given in a baby's bottle.
  • Give Propranolol (Clonafit BETA) solution with or right after a feeding.
  • Give doses of Propranolol (Clonafit BETA) solution at least 9 hours apart.
  • The dose of Propranolol (Clonafit BETA) solution may need to be changed as your child's weight changes. Have your child's weight checked often. Talk with the doctor before changing your child's dose.
  • Give Propranolol (Clonafit BETA) solution on a regular schedule to get the most benefit from it. Giving Propranolol (Clonafit BETA) solution at the same time each day will help you remember to give it.
  • If your child spits up a dose or if you are not sure your child got all of the medicine, do not give another dose. Wait until the next scheduled dose.
  • If you miss giving your child a dose of Propranolol (Clonafit BETA) solution, give it as soon as possible. If it is almost time for the next dose, skip giving the missed dose and go back to your child's regular dosing schedule. Do not give 2 doses at once.

Ask your health care provider any questions you may have about how to use Propranolol (Clonafit BETA) solution.

There are specific as well as general uses of a drug or medicine. A medicine can be used to prevent a disease, treat a disease over a period or cure a disease. It can also be used to treat the particular symptom of the disease. The drug use depends on the form the patient takes it. It may be more useful in injection form or sometimes in tablet form. The drug can be used for a single troubling symptom or a life-threatening condition. While some medications can be stopped after few days, some drugs need to be continued for prolonged period to get the benefit from it.Use: Labeled Indications

Panic disorder: Treatment of panic disorder, with or without agoraphobia.

Seizure disorders: Mono- or adjunctive therapy in the treatment of the Lennox-Gastaut syndrome (petit mal variant), akinetic, and myoclonic seizures; absence seizures (petit mal) unresponsive to succinimides.

Off Label UsesBipolar disorder, manic or mixed episodes

Data from a meta-analysis of 5 randomized, controlled trials supports the use of Clonazepam (Clonafit BETA) in the treatment of acute bipolar mania. Additional data may be necessary to further define the role of Clonazepam (Clonafit BETA) in this condition.

Based on the American Academy of Neurology guideline for the treatment of tardive syndromes, Clonazepam (Clonafit BETA) given for tardive dyskinesia is probably effective in decreasing tardive dyskinesia symptoms in the short-term (approximately 3 months) and is suggested for the short-term treatment of tardive dyskinesia.

Tic disorders

Data from a limited number of patients studied in a single-blind and two retrospective studies suggest that Clonazepam (Clonafit BETA) may be beneficial for multifocal tic disorder or Tourette disorder. Additional data may be necessary to further define the role of Clonazepam (Clonafit BETA) in these conditions.

There are specific as well as general uses of a drug or medicine. A medicine can be used to prevent a disease, treat a disease over a period or cure a disease. It can also be used to treat the particular symptom of the disease. The drug use depends on the form the patient takes it. It may be more useful in injection form or sometimes in tablet form. The drug can be used for a single troubling symptom or a life-threatening condition. While some medications can be stopped after few days, some drugs need to be continued for prolonged period to get the benefit from it.Use: Labeled Indications

Angina, chronic stable: To decrease angina frequency and increase exercise tolerance in patients with angina pectoris.

Cardiac arrhythmias: Control of supraventricular arrhythmias (eg, atrial fibrillation and flutter, atrioventricular nodal reentrant tachycardia) and ventricular tachycardias (eg, catecholamine-induced arrhythmias, digoxin toxicity).

Essential tremor: Management of familial or hereditary essential tremor.

Hypertension: Management of hypertension. Note: Beta-blockers are not recommended as first-line therapy (ACC/AHA [Whelton 2018]).

Migraine headache prophylaxis: Prophylaxis of common migraine headache.

Myocardial infarction, early treatment and secondary prevention: To reduce cardiovascular mortality in patients who have survived the acute phase of myocardial infarction and are clinically stable.

Obstructive hypertrophic cardiomyopathy: Symptomatic treatment of obstructive hypertrophic cardiomyopathy (formerly known as hypertrophic subaortic stenosis).

Pheochromocytoma: As an adjunct to alpha-adrenergic blockade to control blood pressure and reduce symptoms of catecholamine-secreting tumors.

Proliferating infantile hemangioma (Propranolol (Clonafit BETA)): Treatment of proliferating infantile hemangioma requiring systemic therapy.

Off Label UsesAkathisia, antipsychotic-induced

Data from a limited number of patients in 5 randomized, double-blind, controlled studies support the use of Propranolol (Clonafit BETA) in antipsychotic-induced akathisia.

Based on the American Association for the Study of Liver Diseases guidelines on the management of portal hypertensive bleeding in cirrhosis and the British Society of Gastroenterology guidelines on the management of variceal hemorrhage in cirrhotic patients, use of nonselective beta-blockers, such as Propranolol (Clonafit BETA), is effective and recommended for primary and secondary prophylaxis of variceal hemorrhage.

Dosage (Posology) and method of administration

Clonazepam (Clonafit BETA) is available as a tablet. The tablets should be administered with water by swallowing the tablet whole.

Seizure DisordersAdults

The initial dose for adults with seizure disorders should not exceed 1.5 mg/day divided into three doses. Dosage may be increased in increments of 0.5 to 1 mg every 3 days until seizures are adequately controlled or until side effects preclude any further increase. Maintenance dosage must be individualized for each patient depending upon response. Maximum recommended daily dose is 20 mg.

The use of multiple anticonvulsants may result in an increase of depressant adverse effects. This should be considered before adding Clonazepam (Clonafit BETA) to an existing anticonvulsant regimen.

Pediatric Patients

Clonazepam (Clonafit BETA) is administered orally. In order to minimize drowsiness, the initial dose for infants and children (up to 10 years of age or 30 kg of body weight) should be between 0.01 and 0.03 mg/kg/day but not to exceed 0.05 mg/kg/day given in two or three divided doses. Dosage should be increased by no more than 0.25 to 0.5 mg every third day until a daily maintenance dose of 0.1 to 0.2 mg/kg of body weight has been reached, unless seizures are controlled or side effects preclude further increase. Whenever possible, the daily dose should be divided into three equal doses. If doses are not equally divided, the largest dose should be given before retiring.

Geriatric Patients

There is no clinical trial experience with Clonazepam (Clonafit BETA) in seizure disorder patients 65 years of age and older. In general, elderly patients should be started on low doses of Clonazepam (Clonafit BETA) and observed closely.

Panic DisorderAdults

The initial dose for adults with panic disorder is 0.25 mg bid. An increase to the target dose for most patients of 1 mg/day may be made after 3 days. The recommended dose of 1 mg/day is based on the results from a fixed dose study in which the optimal effect was seen at 1 mg/day. Higher doses of 2, 3 and 4 mg/day in that study were less effective than the 1 mg/day dose and were associated with more adverse effects. Nevertheless, it is possible that some individual patients may benefit from doses of up to a maximum dose of 4 mg/day, and in those instances, the dose may be increased in increments of 0.125 to 0.25 mg bid every 3 days until panic disorder is controlled or until side effects make further increases undesired. To reduce the inconvenience of somnolence, administration of one dose at bedtime may be desirable.

Treatment should be discontinued gradually, with a decrease of 0.125 mg bid every 3 days, until the drug is completely withdrawn.

There is no body of evidence available to answer the question of how long the patient treated with Clonazepam (Clonafit BETA) should remain on it. Therefore, the physician who elects to use Clonazepam (Clonafit BETA) for extended periods should periodically reevaluate the long-term usefulness of the drug for the individual patient.

Pediatric Patients

There is no clinical trial experience with Clonazepam (Clonafit BETA) in panic disorder patients under 18 years of age.

Geriatric Patients

There is no clinical trial experience with Clonazepam (Clonafit BETA) in panic disorder patients 65 years of age and older. In general, elderly patients should be started on low doses of Clonazepam (Clonafit BETA) and observed closely.

How supplied

Clonazepam (Clonafit BETA) tablets are available as scored tablets with a K-shaped perforation—0.5 mg, orange (NDC 0004-0068-01); and unscored tablets with a K-shaped perforation—1 mg, blue (NDC 0004-0058-01); 2 mg, white (NDC 0004-0098-01)—bottles of 100.

Imprint on tablets:

0.5 mg — ½ Clonazepam (Clonafit BETA) (front) ROCHE (scored side)

1 mg — 1 Clonazepam (Clonafit BETA) (front) ROCHE (reverse side)

2 mg — 2 Clonazepam (Clonafit BETA) (front) ROCHE (reverse side)

Store at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F).

Distributed by: Genentech USA, Inc., A Member of the Roche Group 1 DNA Way, South San Francisco, CA 94080-4990. Revised: March 2016

General

Propranolol (Clonafit BETA) hydrochloride extended-release capsules provide Propranolol (Clonafit BETA) hydrochloride in a sustained-release capsule for administration once daily. If patients are switched from Propranolol (Clonafit BETA) hydrochloride tablets to Propranolol (Clonafit BETA) hydrochloride extended-release capsules, care should be taken to assure that the desired therapeutic effect is maintained. Propranolol (Clonafit BETA) hydrochloride extended-release capsules should not be considered a simple mg-for-mg substitute for Propranolol (Clonafit BETA) hydrochloride tablets. Propranolol (Clonafit BETA) hydrochloride extended-release capsules have different kinetics and produce lower blood levels. Retitration may be necessary, especially to maintain effectiveness at the end of the 24-hour dosing interval.

Hypertension

The usual initial dosage is 80 mg Propranolol (Clonafit BETA) hydrochloride extended-release capsules once daily, whether used alone or added to a diuretic. The dosage may be increased to 120 mg once daily or higher until adequate blood pressure control is achieved. The usual maintenance dosage is 120 to 160 mg once daily. In some instances a dosage of 640 mg may be required. The time needed for full hypertensive response to a given dosage is variable and may range from a few days to several weeks.

Angina Pectoris

Starting with 80 mg Propranolol (Clonafit BETA) hydrochloride extended-release capsules once daily, dosage should be gradually increased at three- to seven-day intervals until optimal response is obtained. Although individual patients may respond at any dosage level, the average optimal dosage appears to be 160 mg once daily. In angina pectoris, the value and safety of dosage exceeding 320 mg per day have not been established.

If treatment is to be discontinued, reduce dosage gradually over a period of a few weeks.

Migraine

The initial oral dose is 80 mg Propranolol (Clonafit BETA) hydrochloride extended-release capsules once daily. The usual effective dose range is 160 to 240 mg once daily. The dosage may be increased gradually to achieve optimal migraine prophylaxis. If a satisfactory response is not obtained within four to six weeks after reaching the maximal dose, Propranolol (Clonafit BETA) hydrochloride extended-release capsules therapy should be discontinued. It may be advisable to withdraw the drug gradually over a period of several weeks depending on the patient's age, comorbidity, and dose of Propranolol (Clonafit BETA) hydrochloride extended-release capsules.

Hypertrophic Subaortic Stenosis

The usual dosage is 80 to 160 mg Propranolol (Clonafit BETA) hydrochloride extended-release capsules once daily.

Interaction with other medicinal products and other forms of interaction

See also:
What other drugs will affect Clonazepam (Clonafit BETA)?

Effect of Clonazepam (Clonafit BETA) on the Pharmacokinetics of Other Drugs: Clonazepam (Clonafit BETA) does not appear to alter the pharmacokinetics of phenytoin, carbamazepine, or phenobarbital. The effect of Clonazepam (Clonafit BETA) on the metabolism of other drugs has not been investigated.

Effect of Other Drugs on the Pharmacokinetics of Clonazepam (Clonafit BETA): Literature reports suggest that ranitidine, an agent that decreases stomach acidity, does not greatly alter Clonazepam (Clonafit BETA) pharmacokinetics.

In a study in which the 2 mg Clonazepam (Clonafit BETA) orally disintegrating tablet was administered with and without propantheline (an anticholinergic agent with multiple effects on the GI tract) to healthy volunteers, the AUC of Clonazepam (Clonafit BETA) was 10% lower and the Cmax of Clonazepam (Clonafit BETA) was 20% lower when the orally disintegrating tablet was given with propantheline compared to when it was given alone.

Fluoxetine does not affect the pharmacokinetics of Clonazepam (Clonafit BETA). Cytochrome P-450 inducers, such as phenytoin, carbamazepine and phenobarbital, induce Clonazepam (Clonafit BETA) metabolism, causing an approximately 30% decrease in plasma Clonazepam (Clonafit BETA) levels. Although clinical studies have not been performed, based on the involvement of the cytochrome P-450 3A family in Clonazepam (Clonafit BETA) metabolism, inhibitors of this enzyme system, notably oral antifungal agents, should be used cautiously in patients receiving Clonazepam (Clonafit BETA).

Pharmacodynamic Interactions: The CNS-depressant action of the benzodiazepine class of drugs may be potentiated by alcohol, narcotics, barbiturates, nonbarbiturate hypnotics, antianxiety agents, the phenothiazines, thioxanthene and butyrophenone classes of antipsychotic agents, monoamine oxidase inhibitors and the tricyclic antidepressants, and by other anticonvulsant drugs.

See also:
What other drugs will affect Propranolol (Clonafit BETA)?

Propranolol (Clonafit BETA) hvdrochloride (Propranolol (Clonafit BETA)® (Propranolol (Clonafit BETA)) )

Patients receiving catecholamine-depleting drugs such as reserpine should be closely observed if Inderide is administered. The added catecholamine-blocking action may produce an excessive reduction of resting sympathetic nervous activity, which may result in hypotension, marked bradycardia, vertigo, syncopal attacks, or orthostatic hypotension.

Caution should be exercised when patients receiving a beta blocker are administered a calcium-channel blocking drug, especially intravenous verapamil, for both agents may depress myocardial contractility or atrioventricular conduction. On rare occasions, the concomitant intravenous use of a beta blocker and verapamil has resulted in serious adverse reactions, especially in patients with severe cardiomyopathy, congestive heart failure, or recent myocardial infarction.

Both digitalis glycosides and beta-blockers slow atrioventricular conduction and decrease heart rate. Concomitant use can increase the risk of bradycardia.

Blunting of the antihypertensive effect of beta-adrenoceptor blocking agents by nonsteroidal anti-inflammatory drugs has been reported.

Hypotension and cardiac arrest have been reported with the concomitant use of Propranolol (Clonafit BETA) and haloperidol.

Aluminum hydroxide gel greatly reduces intestinal absorption of Propranolol (Clonafit BETA).

Alcohol, when used concomitantly with Propranolol (Clonafit BETA), may increase plasma levels of Propranolol (Clonafit BETA).

Phenytoin, phenobarbitone, and rifampin accelerate Propranolol (Clonafit BETA) clearance.

Chlorpromazine, when used concomitantly with Propranolol (Clonafit BETA), results in increased plasma levels of both drugs.

Antipyrine and lidocaine have reduced clearance when used concomitantly with Propranolol (Clonafit BETA).

Thyroxine may result in a lower than expected TS concentration when used concomitantly with Propranolol (Clonafit BETA).

Cimetidine decreases the hepatic metabolism of Propranolol (Clonafit BETA), delaying elimination and increasing blood levels.

Theophylline clearance is reduced when used concomitantly with Propranolol (Clonafit BETA).

Hydrochlorothiazide

Thiazide drugs may increase the responsiveness to tubocurarine.

Thiazides may decrease arterial responsiveness to norepinephrine. This diminution is not sufficient to preclude effectiveness of the pressor agent for therapeutic use.

Insulin requirements in diabetic patients may be increased, decreased, or unchanged. Hypokalemia may develop during concomitant use of corticosteroids or ACTH.

Drug/Laboratory Test InteractionsHydrochlorothiazide

Thiazides may decrease serum FBI levels without signs of thyroid disturbance.

Thiazides should be discontinued before carrying out tests for parathyroid function.