Clonafit Overdose

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What happens if I overdose Clonafit?

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately. Symptoms may include clumsiness; confusion; difficult or slow breathing; dizziness; drowsiness leading to unresponsiveness or coma; lightheadedness, especially upon standing; loss of consciousness.

Proper storage of Clonafit orally disintegrating tablets:

Store Clonafit orally disintegrating tablets at 77 degrees F (25 degrees C). Brief storage at temperatures between 59 and 86 degrees F (15 and 30 degrees C) is permitted. Store in original foil packaging until just before use. Store away from heat, moisture, and light. Do not store in the bathroom. Keep Clonafit orally disintegrating tablets out of the reach of children and away from pets.

Overdose of Clonafit in details

When a dose is taken in higher dose than the recommended doses, it is called Overdose. Overdose always needs a clinical supervision. Any medicine or drug when consumed in Overdose produces untoward side effects on one or various organs in the body. A medicine is excreted in the kidney or metabolized in the liver most of the times. This process goes without any hurdles when taken in normal dose, but when taken in an overdose, the body is not able to metabolize it or send it out properly which causes the effects of anoverdose.
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Symptoms: Benzodiazepines commonly cause drowsiness, ataxia, dysarthria and nystagmus. Overdosage of Clonafit is seldom life-threatening if Clonafit is taken alone, but may lead to areflexia, apnea, hypotension, cardiorespiratory depression and coma. Coma, if it occurs, usually lasts a few hours but it may be more protracted and cyclical, particularly in elderly patients. Benzodiazepine respiratory depressant effects are more serious in patients with respiratory disease.

Benzodiazepines increase the effects of other central nervous system (CNS) depressants, including alcohol.

Treatment: Monitor the patient's vital signs and institute supportive measures as indicated by the patient's clinical state. In particular, patients may require symptomatic treatment for cardiorespiratory effects or CNS effects.

Further absorption should be prevented using an appropriate method eg, treatment within 1-2 hrs with activated charcoal. If activated charcoal is used airway protection is imperative for drowsy patients. In case of mixed ingestion gastric lavage may be considered, however not as a routine measure.

If CNS depression is severe consider the use of flumazenil (Anexate), a benzodiazepine antagonist. This should only be administered under closely monitored conditions. It has a short t½ (about an hour), therefore, patients administered flumazenil will require monitoring after its effects have worn off. Flumazenil is to be used with extreme caution in the presence of drugs that reduce seizure threshold (eg, tricyclic antidepressants). Refer to the prescribing information for flumazenil (Anexate), for further information on the correct use of Clonafit.

What should I avoid while taking Clonafit?

Avoid drinking alcohol. Dangerous side effects could occur.

Clonafit may impair your thinking or reactions. Avoid driving or operating machinery until you know how this medicine will affect you. Dizziness or severe drowsiness can cause falls or other accidents.

Clonafit warnings

Warnings are a mix of Precautions. Contraindications and interactions and serious harmful effects associated with the medicine intake. A diabetic or Hypertensive patient need to be warned about few drug interactions. A known hypersensitivity patient needs to be careful about the reactions or anaphylactic shock. A pregnant woman or a breastfeeding woman should be warned of certain medications. A Hepatitis [liver disease] patient or a cardiac patient should avoid few drugs.
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General

Worsening of Seizures: When used in patients in whom several different types of seizure disorders coexist, Clonafit may increase the incidence or precipitate the onset of generalized tonic-clonic seizures (grand mal). This may require the addition of appropriate anticonvulsants or an increase in their dosages. The concomitant use of valproic acid and Clonafit may produce absence status.

Laboratory Testing During Long-Term Therapy

Periodic blood counts and liver function tests are advisable during long-term therapy with Clonafit.

Risks of Abrupt Withdrawal

The abrupt withdrawal of Clonafit, particularly in those patients on long-term, high-dose therapy, may precipitate status epilepticus. Therefore, when discontinuing Clonafit, gradual withdrawal is essential. While Clonafit is being gradually withdrawn, the simultaneous substitution of another anticonvulsant may be indicated.

Caution in Renally Impaired Patients

Metabolites of this medicine are excreted by the kidneys; to avoid their excess accumulation, caution should be exercised in the administration of the drug to patients with impaired renal function.

Hypersalivation

this medicine may produce an increase in salivation. This should be considered before giving the drug to patients who have difficulty handling secretions. Because of this and the possibility of respiratory depression, this medicine should be used with caution in patients with chronic respiratory diseases.

Carcinogenesis, Mutagenesis, Impairment of Fertility

Carcinogenicity studies have not been conducted with Clonafit.

The data currently available are not sufficient to determine the genotoxic potential of Clonafit.

In a two-generation fertility study in which Clonafit was given orally to rats at 10 and 100 mg/kg/day (low dose approximately 5 times and 24 times the maximum recommended human dose of 20 mg/day for seizure disorder and 4 mg/day for panic disorder, respectively, on a mg/m2 basis), there was a decrease in the number of pregnancies and in the number of offspring surviving until weaning.

Pregnancy

Teratogenic Effects: Pregnancy Category D

The effect of this medicine on labor and delivery in humans has not been specifically studied; however, perinatal complications have been reported in children born to mothers who have been receiving benzodiazepines late in pregnancy, including findings suggestive of either excess benzodiazepine exposure or of withdrawal phenomena.

Nursing Mothers

Mothers receiving this medicine should not breastfeed their infants.

Pediatric Use

Because of the possibility that adverse effects on physical or mental development could become apparent only after many years, a benefit-risk consideration of the long-term use of this medicine is important in pediatric patients being treated for seizure disorder.

Safety and effectiveness in pediatric patients with panic disorder below the age of 18 have not been established.

Geriatric Use

Clinical studies of this medicine did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Other reported clinical experience has not identified differences in responses between the elderly and younger patients. In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy.

Because Clonafit undergoes hepatic metabolism, it is possible that liver disease will impair Clonafit elimination. Metabolites of this medicine are excreted by the kidneys; to avoid their excess accumulation, caution should be exercised in the administration of the drug to patients with impaired renal function. Because elderly patients are more likely to have decreased hepatic and/or renal function, care should be taken in dose selection, and it may be useful to assess hepatic and/or renal function at the time of dose selection.

Sedating drugs may cause confusion and over-sedation in the elderly; elderly patients generally should be started on low doses of this medicine and observed closely.

What should I discuss with my healthcare provider before taking Clonafit?

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

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

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

Clonafit precautions

Certain people who are very sick or very old or who are sensitive show an exacerbation of side effect of the drug which can turn dangerous at times. So, it is very important to remember the precautions while taking the medicine. Pregnancy and Breastfeeding are also special categories wherein extra care or precaution is needed when taking a drug. Few patients may have a hypersensitivity reaction to few medications, and that can be life-threatening rarely. Penicillin hypersensitivity is one example. Diarrhea, rashes are few other symptoms which need a watch. A patient with other co-existing diseases like liver disease, heart disease, kidney disease should take special precautions.
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General

Worsening of Seizures

When used in patients in whom several different types of seizure disorders coexist, Clonafit may increase the incidence or precipitate the onset of generalized tonic-clonic seizures (grand mal). This may require the addition of appropriate anticonvulsants or an increase in their dosages. The concomitant use of valproic acid and Clonafit may produce absence status.

Laboratory Testing During Long-Term Therapy

Periodic blood counts and liver function tests are advisable during long-term therapy with Clonafit.

Risks of Abrupt Withdrawal

The abrupt withdrawal of Clonafit, particularly in those patients on long-term, high-dose therapy, may precipitate status epilepticus. Therefore, when discontinuing Clonafit, gradual withdrawal is essential. While Clonafit is being gradually withdrawn, the simultaneous substitution of another anticonvulsant may be indicated.

Caution in Renally Impaired Patients

Metabolites of Clonafit are excreted by the kidneys; to avoid their excess accumulation, caution should be exercised in the administration of the drug to patients with impaired renal function.

Hypersalivation

Clonafit may produce an increase in salivation. This should be considered before giving the drug to patients who have difficulty handling secretions.

Respiratory Compromise

Clonafit should be used with caution in patients with compromised respiratory function.

Porphyria

Clonafit may have a porphyrogenic effect and should be used with care in patients with porphyria.

Information for Patients

A Clonafit Medication Guide must be given to the patient each time Clonafit is dispensed, as required by law. Patients should be instructed to take Clonafit only as prescribed. Physicians are advised to discuss the following issues with patients for whom they prescribe Clonafit:

Dose Changes

To assure the safe and effective use of benzodiazepines, patients should be informed that, since benzodiazepines may produce psychological and physical dependence, it is advisable that they consult with their physician before either increasing the dose or abruptly discontinuing this drug.

Interference With Cognitive and Motor Performance

Because benzodiazepines have the potential to impair judgment, thinking or motor skills, patients should be cautioned about operating hazardous machinery, including automobiles, until they are reasonably certain that Clonafit therapy does not affect them adversely.

Suicidal Thinking and Behavior

Patients, their caregivers, and families should be counseled that AEDs, including Clonafit, may increase the risk of suicidal thoughts and behavior and should be advised of the need to be alert for the emergence or worsening of symptoms of depression, any unusual changes in mood or behavior, or the emergence of suicidal thoughts, behavior, or thoughts about self-harm. Behaviors of concern should be reported immediately to healthcare providers.

Pregnancy

Patients should be advised to notify their physician if they become pregnant or intend to become pregnant during therapy with Clonafit. Patients should be encouraged to enroll in the North American Antiepileptic Drug (NAAED) Pregnancy Registry if they become pregnant. This registry is collecting information about the safety of antiepileptic drugs during pregnancy. To enroll, patients can call the toll free number 1-888-233-2334.

Nursing

Patients should be advised not to breastfeed an infant if they are taking Clonafit.

Concomitant Medication

Patients should be advised to inform their physicians if they are taking, or plan to take, any prescription or over-the-counter drugs, since there is a potential for interactions.

Alcohol

Patients should be advised to avoid alcohol while taking Clonafit.

Drug Interactions

Effect of Clonafit on the Pharmacokinetics of Other Drugs

Clonafit does not appear to alter the pharmacokinetics of phenytoin, carbamazepine or phenobarbital. The effect of Clonafit on the metabolism of other drugs has not been investigated.

Effect of Other Drugs on the Pharmacokinetics of Clonafit

Literature reports suggest that ranitidine, an agent that decreases stomach acidity, does not greatly alter Clonafit pharmacokinetics.

In a study in which the 2 mg Clonafit 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 Clonafit was 10% lower and the Cmax of Clonafit 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 Clonafit. Cytochrome P-450 inducers, such as phenytoin, carbamazepine and phenobarbital, induce Clonafit metabolism, causing an approximately 30% decrease in plasma Clonafit levels. Although clinical studies have not been performed, based on the involvement of the cytochrome P-450 3A family in Clonafit metabolism, inhibitors of this enzyme system, notably oral antifungal agents, should be used cautiously in patients receiving Clonafit.

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.

Carcinogenesis, Mutagenesis, Impairment of Fertility

Carcinogenicity studies have not been conducted with Clonafit.

The data currently available are not sufficient to determine the genotoxic potential of Clonafit.

In a two-generation fertility study in which Clonafit was given orally to rats at 10 and 100 mg/kg/day (low dose approximately 5 times and 24 times the maximum recommended human dose of 20 mg/day for seizure disorder and 4 mg/day for panic disorder, respectively, on a mg/m2 basis), there was a decrease in the number of pregnancies and in the number of offspring surviving until weaning.

Pregnancy

Teratogenic Effects

Pregnancy Category D

.

To provide information regarding the effects of in utero exposure to Clonafit, physicians are advised to recommend that pregnant patients taking Clonafit enroll in the NAAED Pregnancy Registry. This can be done by calling the toll free number 1-888-233-2334, and must be done by patients themselves. Information on this registry can also be found at the website http://www.aedpregnancyregistry.org/.

Labor and Delivery

The effect of Clonafit on labor and delivery in humans has not been specifically studied; however, perinatal complications have been reported in children born to mothers who have been receiving benzodiazepines late in pregnancy, including findings suggestive of either excess benzodiazepine exposure or of withdrawal phenomena.

Nursing Mothers

Mothers receiving Clonafit should not breastfeed their infants.

Pediatric Use

Because of the possibility that adverse effects on physical or mental development could become apparent only after many years, a benefit-risk consideration of the long-term use of Clonafit is important in pediatric patients being treated for seizure disorder.

Safety and effectiveness in pediatric patients with panic disorder below the age of 18 have not been established.

Geriatric Use

Clinical studies of Clonafit did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Other reported clinical experience has not identified differences in responses between the elderly and younger patients. In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy.

Because Clonafit undergoes hepatic metabolism, it is possible that liver disease will impair Clonafit elimination. Metabolites of Clonafit are excreted by the kidneys; to avoid their excess accumulation, caution should be exercised in the administration of the drug to patients with impaired renal function. Because elderly patients are more likely to have decreased hepatic and/or renal function, care should be taken in dose selection, and it may be useful to assess hepatic and/or renal function at the time of dose selection.

Sedating drugs may cause confusion and over-sedation in the elderly; elderly patients generally should be started on low doses of Clonafit and observed closely.

What happens if I miss a dose of Clonafit?

When you miss a dose, you should take it as soon as you remember, but you should take care that it should be well spaced from the next dose. You should not take an extra dose at the time of the second dose as it will become a double dose. The double dose can give unwanted side effects, so be careful. In chronic conditions or when you have a serious health issue, if you miss a dose, you should inform your health care provider and ask his suggestion.

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.



References

  1. DailyMed. "CLONAZEPAM: DailyMed provides trustworthy information about marketed drugs in the United States. DailyMed is the official provider of FDA label information (package inserts).". https://dailymed.nlm.nih.gov/dailyme... (accessed September 17, 2018).
  2. DrugBank. "clonazepam". http://www.drugbank.ca/drugs/DB01068 (accessed September 17, 2018).
  3. MeSH. "Anticonvulsants". https://www.ncbi.nlm.nih.gov/mesh/68... (accessed September 17, 2018).

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