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Indications and usage:

Clonazepam (Klonopin, Rivotril) is a benzodiazepine indicated for the treatment of:

seizure disorders in people with epilepsy

specifically petit mal seizures, akinetic seizures

myoclonus, infantile myoclonic, myoclonic, as well as Lennox-Gastaut syndrome

atypical absences

panic attacks, panic disorder, with or without agoraphobia

social phobia

unexpected attacks of overwhelming panic accompanied by fear of recurrence

bipolar disorder

mania

obsessive compulsive disorder

acute psychosis-induced aggression

borderline personality disorder

temporomandibular joint disorder

burning mouth syndrome

hyperekplexia

some movement and muscle disorders as akathisia, restless legs syndrome, primary orthostatic tremor

chronic myofascial pain

cluster-tic syndrome

spasticity related to amyotrophic lateral sclerosis

alcohol and benzodiazepine withdrawal syndromes

migraine prevention

bruxism

rapid eye movement sleep behavior disorder

periodic limb movement disorder

night terrors

for recreational use

insomnia, sleep paralysis, parasomnia and other sleep disorders

for the short-term relief symptoms of anxiety


Dosage and administration:

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

Dosage of Rivotril, Klonopin is essentially individual and depends above all on the age of the patient. Dosage must be determined in each patient according to clinical response and tolerance.

The use of multiple anticonvulsants may result in an increase of depressant adverse effects. This should be borne in mind whenever this medication is added to an already existing anticonvulsant regimen.

Clonazepam should always be prescribed at the lowest effective dose for the shortest duration possible.

Klonopin, Rivotril can produce withdrawal signs and symptoms or rebound phenomena following abrupt discontinuation or rapid dose reduction. Abrupt discontinuation should be avoided and treatment - even if only of short duration - should be terminated by gradually tapering the dosage schedule under close monitoring.

Tapering should be tailored to the specific patient. Special attention should be given to patients with a history of seizure.

If a patient experiences withdrawal signs and symptoms, consider postponing the taper or raising the benzodiazepine to the previous dosage prior to proceeding with a gradual taper.

Geriatric patients in particular may be more sensitive to benzodiazepines.

Long-term use of clonazepam should be avoided in elderly patients. Enhanced monitoring is recommended.


Dosage forms and strengths:

Klonopin (Clonazepam) tablets are available as scored tablets with a K-shaped perforation 0.5 mg, orange; and unscored tablets with a K-shaped perforation 1 mg, blue; 2 mg, white.

Rivotril (Clonazepam) is available as a 0.5 mg, pale orange, cylindrical, biplane, scored tablet, edges bevelled, with ROCHE 0.5 engraved on one face, scored on the other and as a 2.0 mg, white, cylindrical, biplane, scored tablet, edges bevelled, with ROCHE 2 on one side, cross-scored on the other.


Contraindications:

Klonopin and Rivotril (Clonazepam) tablets are contraindicated in patients with the following conditions:

History of sensitivity to benzodiazepines.

Clinical or biochemical evidence of significant liver disease.

Acute narrow angle glaucoma (it may be used in patients with open angle glaucoma who are receiving appropriate therapy).


Overdosage:

Symptoms:

Human experience of clonazepam overdosage, like those produced by other CNS depressants, include somnolence, confusion, coma, and diminished reflexes.

Treatment:

Management of Clonazepam (Klonopin, Rivotril) overdose includes monitoring of respiration, pulse and blood pressure, general supportive measures and immediate gastric lavage. Intravenous fluids should be administered and an adequate airway maintained. Hypotension may be combated by the use of levarterenol or metaraminol. Dialysis is of no known value. Flumazenil, a specific benzodiazepine-receptor antagonist, is indicated for the complete or partial reversal of the sedative effects of benzodiazepines and may be used in situations when an overdose with a benzodiazepine is known or suspected. Prior to the administration of flumazenil, necessary measures should be instituted to secure airway, ventilation and intravenous access. Flumazenil is intended as an adjunct to, not as a substitute for, proper management of benzodiazepine overdose. Patients treated with flumazenil should be monitored for resedation, respiratory depression and other residual benzodiazepine effects for an appropriate period after treatment. The prescriber should be aware of a risk of seizure in association with flumazenil treatment, particularly in long-term benzodiazepine users and in cyclic antidepressant overdose.


Warnings:

Risks from concomitant use with opioids: concomitant use of benzodiazepines, including clonazepam, and opioids may result in profound sedation, respiratory depression, coma, and death.

Abuse, misuse, and addiction: the use of benzodiazepines, including Clonazepam (Rivotril, Klonopin) pills, exposes users to the risks of abuse, misuse, and addiction, which can lead to overdose or death. Abuse and misuse of benzodiazepines often (but not always) involve the use of doses greater than the maximum recommended dosage and commonly involve concomitant use of other medications, alcohol, and/or illicit substances, which is associated with an increased frequency of serious adverse outcomes, including respiratory depression, overdose, or death.

Dependence and withdrawal reactions: to reduce the risk of withdrawal reactions, use a gradual taper to discontinue this medicine or reduce the dosage.

Interference with cognitive and motor performance: since clonazepam produces CNS depression, patients receiving this drug should be cautioned against engaging in hazardous occupations requiring mental alertness, such as operating machinery or driving a motor vehicle.

Suicidal behavior and ideation: antiepileptic drugs (AEDs), including this drug, increase the risk of suicidal thoughts or behavior in patients taking these drugs for any indication.


Precautions:

Worsening of seizures: when used in patients in whom several different types of seizure disorders coexist, Clonazepam (Klonopin, Rivotril) 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 Klonopin may produce absence status.

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

Laboratory testing during long-term therapy: periodic blood counts and liver function tests are advisable during long-term therapy with this drug.

Psychiatric and paradoxical reactions: paradoxical reactions, such as agitation, irritability, aggression, anxiety, anger, nightmares, hallucinations, and psychoses are known to occur when using benzodiazepines. Should this occur, the use of the drug should be discontinued gradually. Paradoxical reactions are more likely to occur in children and in the elderly.

Caution in renally impaired patients: metabolites of clonazepam 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 medication may produce an increase in salivation. This should be considered before giving the drug to patients who have difficulty handling secretions.

Respiratory Depression: Clonazepam (Rivotril, Klonopin) may cause respiratory depression and should be used with caution in patients with compromised respiratory function (e.g., chronic obstructive pulmonary disease, sleep apnea).

Porphyria: this medicine may have a porphyrogenic effect and should be used with care in patients with porphyria.


Adverse reactions, side effects:

The most common adverse reactions of clonazepam include drowsiness, problems with walking and coordination, dizziness, depression, fatigue, problems with memory.

To report suspected adverse reactions of Clonazepam (Klonopin, Rivotril) tablets, contact Roche, Genentech pharmaceutical companies or your local FDA.


Drug interactions:

The concomitant use of benzodiazepines and opioids increases the risk of respiratory depression because of actions at different receptor sites in the CNS that control respiration. Benzodiazepines interact at GABAA sites, and opioids interact primarily at mu receptors. When benzodiazepines and opioids are combined, the potential for benzodiazepines to significantly worsen opioid-related respiratory depression exists. Limit dosage and duration of concomitant use of benzodiazepines and opioids, and follow patients closely for respiratory depression and sedation.

Clonazepam does not appear to alter the pharmacokinetics of carbamazepine or phenobarbital. This medication has the potential to influence concentrations of phenytoin. Monitoring of phenytoin concentration is recommended when clonazepam is co-administrated with phenytoin. The effect of clonazepam on the metabolism of other drugs has not been investigated.

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

In a study in which the 2 mg clonazepam 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 was 10% lower and the Cmax of clonazepam was 20% lower when the orally disintegrating tablet was given with propantheline compared to when it was given alone.

The selective serotonin reuptake inhibitors sertraline (weak CYP3A4 inducer) and fluoxetine (CYP2D6 inhibitor), and the anti-epileptic drug felbamate (CYP2C19 inhibitor and CYP3A4 inducer) do not affect the pharmacokinetics of clonazepam.

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.


Use in specific populations:

Pregnancy

There are no adequate and well-controlled studies of Clonazepam (Klonopin, Rivotril) in pregnant women. Available human data on the risk of teratogenicity are inconclusive. There is insufficient evidence in humans to assess the effect of benzodiazepine exposure during pregnancy on neurodevelopment.

Labor and delivery

The effect of clonazepam 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

The effects of this medicine on the breastfed infant and on milk production are unknown. The developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for clonazepam and any potential adverse effects on the breastfed infant from Klonopin, Rivotril or from the underlying maternal condition.

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 clonazepam is important in pediatric patients being treated for seizure disorder.

Geriatric use

Clinical studies of this drug 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.


Drug abuse and dependence:

Controlled substance: Klonopin and Rivotril contain clonazepam, which is a controlled substance in some countries (for example, Schedule IV in the United States and Canada).